FEDERAL COURT OF AUSTRALIA
Vald Pty Ltd v KangaTech Pty Ltd (No 5) [2024] FCA 333
Table of Corrections | |
In paragraph 367, in the first sentence, the word “however” has been removed and replaced with “in any event” | |
ORDERS
VALD PTY LTD (ACN 603 446 171) Applicant | ||
AND: | KANGATECH PTY LTD (ACN 609 070 340) Respondent | |
AND BETWEEN: | KANGATECH PTY LTD (ACN 609 070 340) Cross-Claimant | |
AND: | VALD PTY LTD (ACN 603 446 171) Cross-Respondent |
DATE OF ORDER: |
THE COURT ORDERS THAT:
1. The parties are to confer and provide to the chambers of Downes J an agreed form of order giving effect to the reasons for judgment and proposed directions as to the further conduct of this proceeding by 12.00 pm AEST on 12 April 2024.
2. If the parties are unable to agree upon a form of order and proposed directions, the parties shall each provide their proposed draft of same to the chambers of Downes J by 12.00 pm AEST on 16 April 2024 accompanied by any written submissions not exceeding three (3) pages.
Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.
[1] | |
[14] | |
[14] | |
[17] | |
[21] | |
[22] | |
[25] | |
[25] | |
[31] | |
[52] | |
[73] | |
[78] | |
[80] | |
[81] | |
5.2 Whether claims require assessment of strength in reliable and accurate way | [84] |
[93] | |
[143] | |
[144] | |
[147] | |
[160] | |
[162] | |
[162] | |
[163] | |
[164] | |
[179] | |
[186] | |
[188] | |
[188] | |
[197] | |
[199] | |
[200] | |
[219] | |
[231] | |
[232] | |
[232] | |
[255] | |
[261] | |
[264] | |
[282] | |
[282] | |
7.5.2 The demonstrations of the Other Nordics on Post-SM KT360 | [288] |
[309] | |
[316] | |
[327] | |
[334] | |
7.6 Whether exploitation of claims by sale of Post-First SM KT360 | [336] |
[343] | |
[347] | |
[362] | |
7.8 Whether KangaTech has authorised infringement of the claims | [371] |
[374] |
DOWNES J:
1 The applicant and cross-respondent (Vald) is the registered proprietor of Australian Standard Patent No. 2012388708 entitled “Apparatus and method for knee flexor assessment” (Patent).
2 The Patent claims a priority date of 3 September 2012 (the priority date).
3 In general terms, the Patent concerns an apparatus for use in assessing the strength of a knee flexor muscle of a person and, in one example, for assessing hamstring strength while the person performs an eccentric knee flexor contraction. In passing, I observe that the first “e” in “eccentric” in this context is pronounced with a long vowel sound, like “email”.
4 The respondent and cross-claimant (KangaTech) carries on the business of developing and commercialising testing devices to assist athletic performance and the prevention of physical injuries. KangaTech admits that it has made, sold and supplied, and offered to make, sell and supply (among other acts) in Australia the following devices:
(1) before approximately November 2018, the KangaTech Product (also called the KT Product);
(2) since approximately December 2018, the KT360 (also called the KangaTech360). The software code of the KT360 was modified in December 2019 and again in July 2022.
5 Vald alleges that, by its conduct, KangaTech has infringed claims 1–4, 6–14 and 16–20 of the Patent. Vald does not press its allegations of infringement of claims 5 or 15 of the Patent.
6 KangaTech accepts that, if any of claims 1–3, 6–14 and 18–20 are found to be valid, then KangaTech’s exploitation of the KangaTech Product infringed such claims. For the following reasons, claims 4, 16 and 17 were also infringed.
7 KangaTech also did not challenge the infringement case in relation to the KT360 prior to the software modifications being made to that device.
8 However, KangaTech did challenge the infringement case in relation to the versions of the KT360 following the software modifications. For the reasons which follow, that challenge was successful.
9 KangaTech otherwise denies infringement for reasons which include that the claims of the Patent are invalid for lack of support (s 40(3) of the Patents Act 1990 (Cth)), lack of sufficiency (s 40(2)(a) of the Patents Act) and want of inventive step. However, it did not press these claims if I adopted a particular construction of claim 1 of the Patent (which, for the following reasons, I have done).
10 By its cross-claim, it seeks orders which include an order revoking the claims of the Patent pursuant to s 138 of the Patents Act. That cross-claim should therefore be dismissed.
11 The present hearing concerns liability only, liability and quantum having been separated by an order of Greenwood J made on 21 August 2019. While Vald seeks additional damages, it is common ground that Vald’s entitlement to, and the quantum of, any additional damages is to be determined as part of any quantum phase of the proceeding.
12 I will order the parties to confer with a view to drafting a form of order giving effect to my findings and draft directions in relation to the further conduct of this proceeding. Subject to hearing from the parties, my preference is that any costs orders await the outcome of the further hearing.
13 Additionally, the parties should have leave to appeal and, if necessary, leave to cross-appeal.
2. WITNESSES CALLED BY THE PARTIES
14 Dr Tania Pizzari is a physiotherapist and academic and the expert witness called by Vald in this proceeding. Dr Pizzari holds a Bachelor of Physiotherapy and a Doctorate of Philosophy in the field of physiotherapy. Since 1997, she has worked as a physiotherapy clinician in hospitals, rehabilitation centres and private practice. Since 2000, Dr Pizzari has worked as a lecturer and researcher within the La Trobe University School of Allied Health. Her research focus includes the prevention and treatment of sport-related soft tissue injuries, including hamstring injuries. Since 2014, Dr Pizzari has been an Adjunct Senior Research Fellow at the Australian Centre for Research into Injury in Sports and its Prevention and has managed the Australian Football League (AFL) soft tissue registry which receives, collates and researches data provided by AFL clubs on all hamstring injuries that occur in players. Dr Pizzari is widely published and is regularly invited to present her research at national and international sports medicine and physiotherapy conferences. Dr Pizzari’s evidence was contained in three affidavits which were filed on 4 February 2021, 2 June 2022 and 6 July 2023. Dr Pizzari gave oral evidence together with the expert called by KangaTech (Dr Lovell) during a concurrent session on the second and third day of trial.
15 Ms Grace Gunn, solicitor, affirmed an affidavit dated 30 June 2023 and was cross-examined on the first day of trial.
16 Ms Ashleigh Sams, solicitor, swore an affidavit dated 4 February 2021 and was not required for cross-examination.
2.2 Witnesses called by KangaTech
17 Mr Carl Dilena is a non-executive Director and Chairman of the Board of KangaTech. He is qualified as a Chartered Accountant and holds a Bachelor of Economics and a Master of Business Administration. Mr Dilena affirmed one affidavit in this proceeding dated 17 July 2023 (with an unsigned version filed on 7 December 2021). Mr Dilena was cross-examined on the first day of trial.
18 Mr David Scerri is the Chief Technical Officer of Biarri Optimisation Pty Ltd, a company which develops bespoke commercial mathematics software for businesses. Mr Scerri holds a Bachelor of Science (majoring in computer science) from Royal Melbourne Institute of Technology University. From November 2015 until July 2020, he was the Chief Technical Officer of KangaTech. Mr Scerri affirmed one affidavit in this proceeding dated 18 July 2023 (with an unsigned version filed on 7 December 2021). Mr Scerri was cross-examined on the second day of trial.
19 Dr Steven Saunders is a science and medicine consultant, clinician and researcher. He holds a Bachelor of Applied Science, Physiotherapy from Sydney University and a PhD from the University of Queensland. He is also a founder and director of KangaTech. Dr Saunders affirmed three affidavits in this proceeding dated 19 July 2023 (with unsigned versions being filed on 7 December 2021, 8 July 2022 and 3 July 2023). Dr Saunders was not required for cross-examination.
20 Dr Ric Lovell, a sports scientist and academic, is the expert called by KangaTech in this proceeding. Dr Lovell holds a Bachelor of Sports Studies and a Masters of Sport Science from Teesside University in Middlesbrough, United Kingdom, and a Doctorate in Sport and Exercise Science from the University of Hull, United Kingdom. Dr Lovell worked as a sports physiologist at the University of Hull from 2006 to 2011. Since 2011, he has worked as a Senior Lecturer and, since 2019, has been an Associate Professor in Sport and Exercise Science at the University of Western Sydney. Dr Lovell’s primary research focus is optimal preparation and athletic development strategies for soccer players, including injury prevention and monitoring training and match loads. Dr Lovell has worked with various sports organisations in roles that include measuring and recording athletes’ lower limb muscle strength to assist their preparation, development and injury prevention. Dr Lovell’s evidence was contained in two affidavits which were filed on 7 January 2022 and 8 July 2022. Dr Lovell, together with Dr Pizzari, gave oral evidence during the concurrent session on the second and third day of trial.
21 A joint expert report was prepared with the helpful assistance of a judicial registrar of this Court. The report followed a conclave attended by the expert witnesses, Dr Pizzari (for Vald) and Dr Lovell (for KangaTech). The report is dated 5 June 2023 and was filed on 29 June 2023 (JER).
2.4 Observations about the experts
22 The primary role of the independent experts was to assist the Court in understanding the technical background to, and the purpose of, the invention. In this regard, for the reasons given below and elsewhere in the judgment, the evidence of Dr Lovell has generally been preferred to the evidence of Dr Pizzari, where their evidence is in conflict.
23 Dr Lovell gave careful and considered answers to questions asked of him during the hearing, appeared to be attempting to assist the Court and, by his answers and general demeanour, did not appear to be favouring any party or outcome in the dispute.
24 By contrast, Dr Pizzari did, on occasion, appear to be seeking to assist Vald when answering questions asked of her during the concurrent session, which affected my perception of her independence. This was particularly evident when Dr Pizzari gave oral evidence about key disputed terms in the claims. During that evidence, Dr Pizzari appeared determined to ignore the plain meaning of parts of the specification which was inconsistent with her preferred construction of the claims. This occurred when Dr Pizzari gave oral evidence concerning her understanding of the consistory clauses and even extended to Dr Pizzari giving evidence that claim 18 – which refers to “securing the lower legs of the subject, using the respective securing members” – also encompasses only one leg being secured (which was inconsistent with her own affidavit evidence but which was evidence which was favourable to Vald’s case).
25 The Patent claims an earliest priority date of 3 September 2012, being the date on which the application was filed under the terms of the Patent Cooperation Treaty: s 30 of the Patents Act; reg 3.5AA(a) of the Patents Regulations 1991 (Cth). That application was filed by the Queensland University of Technology (QUT) and entered the national phase of processing on 25 February 2015.
26 The Commissioner of Patents issued a direction to QUT to request an examination of the Patent on 5 October 2016. In compliance with that direction, QUT requested an expedited examination of the Patent on 22 November 2016. Relevantly, because the examination was requested after the commencement of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth), the Patent is subject to the Patents Act as amended by that Act: s 2 and Sch 1 item 55.
27 On 2 November 2017, IP Australia accepted an application by QUT to amend the Patent. Those amendments will become relevant later in these reasons.
28 The Patent was granted on 8 March 2018.
29 Relevantly, by a licence agreement dated 16 December 2014, QUT had earlier granted QUTBluebox Pty Ltd an exclusive licence to exploit the Patent.
30 On 11 November 2019, QUT and QUTBluebox Pty Ltd entered a deed of assignment with Vald, by which they assigned to Vald all of their property, rights, title and interest in and to the Patent, including all rights of action. As such, on 15 November 2019, Vald became the registered proprietor of the Patent.
3.2 Nordic curl or Nordic Hamstring Exercise
31 The primary muscle group that flexes (bends) the knee is the hamstring muscle group. The hamstrings are made up of the semimembranosus, the semitendinosus and the bicep femoris. Other muscles that contribute to knee flexion include the gracilis, the gastrocnemius and the sartorius. These muscles are referred to at [0074] of the specification of the Patent as the knee flexor muscles.
32 During an eccentric contraction, the muscle lengthens as the resistance becomes greater than the force which the muscle is producing whereas during a concentric contraction, the tension in the muscle increases to meet the resistance then remains stable as the muscle shortens. During an isometric contraction, the muscle does not change length during a contraction.
33 A Nordic curl or Nordic Hamstring Exercise (NHE) is an exercise thought to contribute to a reduction in hamstring injury (or HSI). According to Dr Lovell’s evidence in his first affidavit:
…This is primarily because it is an exercise which builds strength in the hamstrings through an eccentric contraction – that is, as the hamstrings are lengthening while they are under significant tension…
In its modern form, the NHE is performed [as follows]. That is, the athlete kneels on a padded surface of some sort – facing away from either a person (who will restrain her/his ankles) or, if being performed without assistance, with the athlete placing their ankles under an immovable restraint which may or may not be attached to the pad on which the subject kneels (for example, gymnasium wall-bars, a loaded barbell, sit-up apparatus, or common resistance training equipment). At the start, the torso is vertical, and the athlete then slowly leans forward from the knees, lowering their torso in a controlled manner. The pivot point is the knees rather than the hips. While doing this, athlete’s ankles/lower legs are restrained from moving upwards – either by another person or a firm restraint against which their ankles are pressing.
The motion forward in the NHE is done in a slow and controlled manner as the aim of the exercise is to benefit from the eccentric contraction of the hamstrings. This eccentric contraction controls (slows) the gradual lengthening of the hamstrings while they are under tension resisting the forward motion of the torso. Most people – unless they are elite athletes – are unable to control the movement of their torso much beyond 30 degrees (from a vertical position) and accordingly, they will need to catch their upper body with their hands at the end of the exercise.
The building of strength using the NHE, as a training exercise not only strengthens the hamstrings but, because that strengthening is performed while the muscle is under tension and is also increasing in length – the NHE is also thought to assist in preventing HSI. The NHE can also assist an athlete to regain strength (and confidence) after suffering a hamstring injury as they prepare to return to their athletic discipline.
In order to determine whether these benefits are achieved and to assist athletes to reach their potential and, wherever possible to evaluate the risk of injury, sports scientists and those working in the field of training elite athletes, seek to accurately measure the forces generated by muscles in performing various knee flexion/extension actions.
(Emphasis original.)
34 When a subject’s knee flexor muscle force is measured during a Nordic curl, inferences can be drawn as to injuries, recovery rates and improvements from, for example, muscle strengthening activities.
35 Typically, the Nordic curl is performed using the knee flexor muscles in both legs (also called a bilateral Nordic curl). In such a situation, both legs are secured (such as by holding both ankles). However, the Nordic curl may also be performed using one leg (also called a unilateral Nordic curl). In performing a unilateral Nordic curl, the intention is for the subject (as best as they can) to hold their body up during descent using the hamstring muscles in one leg. The leg not in use is called the contralateral leg and must not be secured. If the contralateral leg is secured, the exercise being performed is no longer a unilateral Nordic curl but a bilateral Nordic curl.
36 In his first affidavit, Dr Lovell expressed concerns about asking an athlete to perform a one-legged NHE on the basis that it would be encouraging the performance of an activity that may lead to an HSI. He further stated:
In my opinion there would only be a small proportion of highly elite athletes who might be capable of performing such an exercise without unacceptable risk. It is not something I would ask an athlete to do, nor would I prescribe a unilateral NHE as part of an exercise program.
37 In his second affidavit, Dr Lovell stated that:
In my experience, even most elite athletes are unable to perform what I would describe as a controlled lengthening of the knee flexor unless both his or her legs are restrained or their body weight is, at least partly, supported in some manner – for example with resistance bands…
(Emphasis original.)
38 During the concurrent evidence session, Dr Lovell stated that:
I would say that it’s a relatively limited group of people that were familiar and advocating this kind of exercise [as at 3 September 2012], in my opinion. I would also state that performing unilateral in the way that you mention can certainly have some benefits but only, in my opinion, having read this information, only in the context of having some form of support to perform that unilateral exercise. So I agree that the unilateral exercise is important. Personally I wouldn’t do it without some additional support to stop rotation of the body during the exercise and also to make sure that we don’t exacerbate risk to the client.
(Emphasis added.)
39 This was consistent with the evidence of Dr Lovell in the JER that:
I consider unilateral (single leg) Nordic Curls to be of limited value unless performed with adequate support for both the contralateral leg and the torso to provide the necessary time under tension to either a) stimulate musculotendon unit adaptations or b) assess the eccentric hamstring muscle strength of a single limb with adequate measurement precision... Having been introduced to the concept, I agree that by using external support structures …, time under tension can be increased and the exercise can be useful in increasing unilateral eccentric strength. I maintain that without such support, assessment of unilateral hamstring strength via single leg Nordic curls is confounded by the stability requirements of the contralateral limb, and the speed of descent.
40 By contrast, Dr Pizzari did not think it was necessary to have support to reduce risk when performing a unilateral Nordic.
41 However, Dr Pizzari’s evidence concerning the topic of unilateral Nordic curls was difficult to follow and, in some respects, confusing and inconsistent. By her second affidavit, she stated that:
In my view, a single leg Nordic curl was (before the Relevant Date) and is an appropriate exercise for various athletes or subjects who have been specifically focused on building up hamstring strength through prior exercises.
42 During the concurrent evidence session, Dr Pizzari agreed that the NHE was not commonplace amongst elite sportspeople, indicated that she prescribed it for “younger athletes” and volunteered that “Most people don’t do Nordics if they’re not athletic”. Dr Pizzari also gave this evidence:
MR FITZPATRICK: And how did those patients perform the unilateral Nordic hamstring exercise?
DR PIZZARI: So within the clinic we had the gym bars, so the railings that are set up, stuck to the wall. And so they would hook their ankle heel under those gym bars or – and perform the Nordic in that way.
MR FITZPATRICK: So they perform these exercises in your – in the setting of your practice?
DR PIZZARI: Correct. And then they were encouraged to find a way to do that at home. So some people would do it just under their bed railings, for example, and some people may have had assistance by someone else holding their leg, which is reasonably common practice way of doing Nordic as well.
MR FITZPATRICK: Yes. And these exercises, when they were conducted in your practice, were supervised by you.
DR PIZZARI: Not always. They were – certainly initially when we – they were prescribed, but then if they came to the practice and were doing a gym sort of program that was part of it, then certainly they could be doing that independently.
MR FITZPATRICK: And did any of the patients performing this exercise measure the muscle force generated by the exercise?
DR PIZZARI: No.
(Emphasis added.)
43 Dr Pizzari also gave evidence at trial that she did not think that an eccentric contraction necessarily has to be controlled: T159/1–5. She later repeated this evidence, saying that:
An eccentric contraction, to be called eccentric, doesn’t have to be controlled, but I think a Nordic hamstring exercise, to the best that the person can perform it, should try and minimise that fall….
(Emphasis added.)
44 However, in Dr Pizzari’s first affidavit, in the context of discussing her interpretation of the Patent, she stated that:
An eccentric knee flexor contraction involves the controlled lengthening of the knee flexor as the subject lengthens his or her leg from a kneeling position, specifically a “Nordic contraction”.
(Emphasis added.)
45 This inconsistency between her affidavit and oral evidence raises a real doubt as to precisely what type of exercise Dr Pizzari was asking her patients to perform as at the priority date, and about her understanding of the unilateral Nordic curl (both as at the priority date and in the context of her evidence concerning her understanding of the claims). Further and in any event, Dr Pizzari did not obtain force measurements from the performance of this exercise by her patients.
46 This raises a real question about whether the performance of a unilateral or one-legged Nordic curl for the purposes of obtaining a reliable force measurement (and how that would be done) was common general knowledge as at the priority date.
47 As Vald submits, the common general knowledge is that which is “known and accepted without question by the bulk” of those in the art: see Idenix Pharmaceuticals LLC v Gilead Sciences Pty Ltd (2017) 134 IPR 1; [2017] FCAFC 196 at [192] (Nicholas, Beach and Burley JJ). Further, as Vald also submits, the fact that witnesses knew something at the priority date does not establish that it was common general knowledge. Conversely, that an expert was not aware of certain information “may be evidence, possibly powerful evidence depending on the circumstances”, that the information was not common general knowledge: Boehringer Ingelheim Animal Health USA Inc v Elanco New Zealand (2021) 164 IPR 17; [2021] FCA 1457 at [180] (Besanko J).
48 In this case, there is such powerful evidence, being that of Dr Lovell, an experienced sports scientist who has worked in the United Kingdom and Australia, and who has consulted for or worked with (for example) the English Premier League, Football Australia and the AFL before the priority date. His evidence is that he has never asked someone to perform an NHE, or observed an NHE being performed, with only one lower leg of the subject being restrained – whether using an apparatus said to fall within this Patent or any other apparatus – either in clinical practice or in training or strength assessments. I accept this evidence. One would have expected Dr Lovell to have been taught about, seen or himself asked someone to perform a unilateral Nordic curl at some stage between 2002 (when he obtained his first degree) and the priority date in 2012, a decade later, if such an exercise was common general knowledge as at the priority date.
49 Vald submits that nothing turns on whether unilateral Nordic curls were common general knowledge as at the priority date; however, I disagree. It is relevant to both construction of the specification as well as invalidity.
50 For these reasons, I find that the performance of a unilateral or one-legged Nordic curl for the purposes of obtaining a reliable force measurement, and the manner in which such an exercise would be done, are matters which were not common general knowledge as at the priority date.
51 My concerns about Dr Pizzari’s evidence also causes me to prefer the evidence of Dr Lovell (which is set out above) on the topic of unilateral Nordic curls generally. For that reason, I find that there is a real risk of an HSI if a person attempts to use the hamstring muscles in one leg only to stop their body from falling forward in a kneeling position (that is, if they attempt to perform a unilateral Nordic curl). The use of a support will reduce the risk, will stop rotation of the body and, if the exercise is being done for strengthening purposes, a support will assist in providing control so as to enable the gradual lengthening of the hamstrings while they are under tension.
52 The invention is entitled “Apparatus and method for knee flexor assessment”.
53 At [0001], the “Background of the Invention” is stated as follows:
The present invention relates to an apparatus for use in assessing the strength of at least one knee flexor muscle of a subject, and in one example, for assessing at least the hamstring strength in at least one leg of the subject while the subject performs an eccentric knee flexor contraction.
54 In the section entitled “Description of the Prior Art” at [0003] and [0004], the specification refers to the prevalence of HSIs in amateur and elite participants in a number of sports, and the high rate of reoccurrence after an initial HSI, with the period of recovery increasing following subsequent HSIs. It observes that numerous investigations have been conducted into the factors that influence a subject’s susceptibility to HSI, as well as circumstances which aid a subject’s recovery and decrease instances of reoccurrence. It refers to a study concerning the correlation between hamstring strength and the incidence of HSIs and then refers to another patent (WO-03/094732) as providing an example apparatus for performing eccentric exercises including a padded board and ankle straps.
55 The specification then details various limitations with existing devices for quantitatively assessing knee flexor muscle strength, such as the current “gold standard” laboratory based isokinetic dynamometer. At [0005], the specification explains that during assessment on an isokinetic dynamometer:
[A] subject is seated, or prone, with an ankle secured to a rotatable arm such that the torque applied by the leg upon rotating the arm is sensed, while the maximum velocity of rotation is constrained by the dynamometer. Isokinetic dynamometers are, however, expensive, require experienced operators, have limited portability, and require significant time to assess each leg of a subject independently... Thus they are largely used for research purposes and only occasionally by elite athletes or sporting teams to assess players at a higher risk of HSI, or to monitor rehabilitation progress. Furthermore, there is a perception among some sporting support personnel that isokinetic dynamometry itself poses an injury risk.
56 After identifying other disclosures and devices, the specification then explains at [0012]:
It will be appreciated that the abovementioned disclosures suffer from a number of disadvantages including a substantial size or weight which impedes portability, and, significant assessment times that preclude mass screenings, for example, of entire sporting teams. Furthermore, previous methods and apparatus have failed to provide simultaneous assessment of hamstring strength in both legs, independently, during a bilateral exercise, or a combined assessment of hamstring strength in both legs during a bilateral exercise. Additionally existing techniques have questionable reliability and repeatability of measurements of between limb strength imbalances.
57 In clause [0013], the specification states that the invention seeks to ameliorate “one or more” of the problems associated with the prior art.
58 Under the heading “Summary of the Present Invention”, the specification goes on to describe the invention in what are termed three “broad forms” or consistory clauses. Each of these broad forms describes an apparatus in which both legs of the subject are secured or constrained by the securing members.
59 In relation to the first broad form, which is addressed at [0014] to [0039], the following is stated:
[0014] In a first broad form the present invention seeks to provide an apparatus for use in assessing strength of at least one knee flexor muscle of a subject, the apparatus including:
a) a support;
b) two securing members, each securing member securing a respective lower leg of the subject in a position that in use is substantially fixed relative to the support; and,
c) at least one sensor, which in use senses a force indicative of the strength of the at least one knee flexor muscle in at least one leg of the subject while the subject performs an eccentric contraction of the at least one knee flexor muscle.
[0015] Typically the at least one sensor is coupled to at least one of the two securing members, and wherein the sensor senses a force exerted at an [sic] lower leg of the subject.
[0016] Typically the at least one sensor includes two sensors, each sensor being coupled to a respective securing member to thereby sense the force indicative of the strength of the at least one knee flexor muscle in each leg of the subject.
[0017] Typically in use the sensors sense the force indicative of the strength of the at least one knee flexor muscle in each leg of the subject simultaneously.
[0018] Typically in use the sensors sense the force indicative of the strength of the at least one knee flexor muscle in each leg of the subject at different times.
…
[0038] Typically the sensor senses a force indicative of the hamstring strength in at least one leg of the subject while the subject performs a Nordic hamstring exercise.
[0039] Typically the at least one knee flexor muscle includes at least a hamstring muscle.
(Emphasis added.)
60 The second broad form describes the same apparatus for assessing the muscle strength of a subject and is not confined to the measurement of knee flexor muscle strength. It is addressed at [0040] in these terms:
In a second broad form the present invention seeks to provide an apparatus for use in assessing muscle strength of a subject, the apparatus including:
a) a support;
b) two securing members, each securing member constraining movement of a respective lower leg of the subject relative to the support; and,
c) at least one sensor, which in use senses a force indicative of the muscle strength while the subject performs an exercise of the muscle, the exercise exerting at least some force on the sensor.
(Emphasis added.)
61 The third broad form describes a method for assessing hamstring strength of a subject using the apparatus. It is addressed at [0041] to [0047]. This part of the specification includes the following:
[0041] In a third broad form the present invention seeks to provide a method of assessing hamstring strength of a subject using an apparatus including a support, two securing members, and at least one sensor, the method including:
a) securing two lower legs of a subject using the respective securing members, at a position that is in use substantially fixed relative to the support;
b) sensing a force indicative of the strength of the at least one knee flexor muscle in at least one leg of the subject using the sensor while the subject performs an eccentric contraction of at least a hamstring.
[0042] Typically at least one sensor includes two sensors, each sensor being coupled to a respective securing member, and wherein the method includes sensing the force indicative of the strength of the at least one knee flexor muscle in each leg of the subject.
[0043] Typically the method includes sensing the force indicative of the strength of the at least one knee flexor muscle in each leg of the subject simultaneously.
[0044] Typically the method includes sensing the force indicative of the hamstring strength in at least one leg of the subject while the subject performs a Nordic hamstring exercise.
(Emphasis added.)
62 The specification then contains a “Brief Description of the Drawings”, being examples of the invention. Those drawings will be addressed in these reasons where relevant. However, it suffices to observe that the drawings portray various examples of the apparatus, including examples of the apparatus in use by a subject performing a bilateral NHE. There is no drawing of a subject performing a unilateral NHE on any example of the apparatus.
63 Figures 1D to 1F are schematic drawings of a first example of a subject performing an eccentric contraction of at least a knee flexor using the apparatus: [0050]. They depict a subject performing a bilateral NHE (with both legs secured in the securing members) as follows:
64 The various drawings are referred to throughout the section of the specification entitled “Detailed Description of the Preferred Embodiments”. The following is stated in relation to Figures 1A to 1F:
[0072] In this example, the apparatus 100 includes a support 110, and two securing members 121, 122, that in use secure a respective lower leg of the subject S in a position that is substantially fixed relative to the support 110.
[0073] The apparatus 100 further includes two sensors 130.1, 130.2 that, in use, sense a force indicative of the strength of at least one knee flexor muscle in one or both legs of the subject S while the subject S performs an eccentric contraction of the at least one knee flexor muscle.
[0074] It should be noted that the knee flexor muscles typically include the three major hamstring muscles, semitendinosus, semimembranosus and biceps femoris, as well as the minor knee flexors, sartorius, gastrocnemius, and gracilis. For ease, the following description will refer primarily to measuring the strength of the hamstring. However, it will be appreciated that the techniques can apply to measuring any one or more of the knee flexor muscles and that reference to the hamstring is not intended to be limiting.
[0075] Figures 1D to 1F show a subject S performing an eccentric contraction of at least a hamstring using the apparatus 100. In this respect, Figure 1D shows the subject S in an initial kneeling position prior to commencing the contraction, in which the subject’s lower legs are secured using the respective securing members 121, 122 in a position that in use is substantially fixed relative to the support. The subject S subsequently proceeds to lower their upper body toward the support 110 in a controlled manner, while substantially maintaining alignment of the upper legs or thighs and torso, as shown in Figure 1E. Figure 1F shows a final position, with the subject S laying substantially prone on the support 110. It will be appreciated that the abovementioned eccentric contraction is typically called the ‘Nordic hamstring exercise’, ‘Nordic curl’, or the like.
[0076] Accordingly, the above-described arrangement provides apparatus 100 for use in assessing hamstring strength of a subject S, in which the force exerted at the lower leg of the subject S while they perform an eccentric contraction of at least the hamstring is indicative of hamstring strength. In this regard, the apparatus 100 can be utilised to monitor hamstring strength, including any changes in hamstring strength over time, for example, to detect injury precursors such as temporal strength differences, imbalances between legs at rest (i.e. not fatigued) or in response to fatigue, to monitor rehabilitation progress, to monitor progress during strength training, or to benchmark against a population. Additionally or alternatively, the apparatus 100 can also be used in order to strengthen the hamstring, for example, by performing repetitions of an eccentric contraction of the hamstring using the apparatus 100, such as shown in Figures 1D to 1F.
…
[0079] It will also be appreciated that the apparatus 100 including two sensors 130.1, 130.2 allows the assessment of the hamstring strength of both hamstrings of a subject S, at the same time. Accordingly the sensors 130.1, 130.2 may sense the force indicative of at least the hamstring strength in each leg of the subject S simultaneously. In this regard, the assessment may be performed in significantly less time than existing methods, for example isokinetic dynamometry, which is limited to assessing hamstrings of opposing legs at different times. The apparatus also appears to provide enhanced sensitivity and reliability for the assessment of between limb strength imbalances compared to existing techniques. This reduces the time required to assess a subject S, which allows the assessment of hamstring strength to become accessible to entire sporting teams as part of regular health and fitness assessments. In this example, two sensors 130.1, 130.2 are shown, however this is not essential and any number of sensors, including a single sensor may be used for monitoring force in one leg, or alternatively a single sensor may be used to monitor the combined hamstring strength of both legs.
[0080] In this example, an eccentric contraction of at least the hamstring of a subject S is shown in Figures 1D to 1F, however it will be appreciated that any suitable exercise which includes an eccentric contraction of the hamstring may be performed. For example, the subject’s hip may be positioned differently, such that the eccentric contraction is performed with the subject's hip and trunk flexed forward. However, this is not essential, and although in this example, the apparatus 100 is for use during an eccentric contraction of at least the hamstring of a subject S, it will be appreciated that the apparatus 100 may be used to measure other muscles or muscles groups while performing other types of muscle contractions. For example, the apparatus 100 may be used to assess any suitable muscle or muscle group, such as the knee flexor, hip flexor, knee extensor, quadriceps, or the like. In this regard, the assessment may be made during an eccentric, isometric, or concentric contraction, or the like, of the respective muscle or muscle group.
65 At [0083], it is stated that a number of further features will now be described.
66 The section of the specification following this statement includes [0085], which was the focal point of the expert evidence of Dr Pizzari in support of Vald’s posited construction of claim 1:
Furthermore, the assessment of hamstring strength may occur during a unilateral or bilateral contraction/s of the hamstring/s. For example, during a bilateral contraction, two sensors 130.1, 130.2 may be used to sense the force in each leg of the subject simultaneously or at different times, or alternatively a single sensor 130.1, 130.2 may be used to sense the force in either or both legs. During a unilateral contraction, the apparatus may include one sensor 130.1, 130.2 which is interchangeable between the lower legs of the subject, by repositioning the sensor 130.1, 130.2 and/or the securing members 121, 122 and/or the subject S relative to the support 110, such that the hamstring strength in both legs can be assessed sequentially. However, this feature is not essential.
67 The specification addresses the support from [0088] to [0095] (which is relevant to one of the issues of construction).
68 For example, at [0091], it is stated that the support 110 may include any suitable shape, including oval, circular, polygonal, square, rectangular, ergonomic, or the like. Furthermore, the support 110 may be composed of any suitable material in order to withstand the weight of at least part of the subject S, such as timber, medium density fibreboard (MDF), plastic, fibreglass, carbon fibre reinforced polymer (CFRP), aluminium, or the like.
69 At [0093], it is stated that:
It will also be appreciated that whilst a single unitary support is shown, this is for ease of illustration only and that in practice the support could be formed from multiple support members, which may or may not be interconnected. In one example, the support could include two parallel support members, each of which is for coupling to a respective securing member.
70 The specification addresses IT aspects of the apparatus and methods of assessment from [0145] to [0169].
71 The specification then describes the various experiments that were performed to demonstrate the effectiveness of the invention as arranged in Figures 1A to 1C. These experiments are addressed in further detail below.
72 Finally, the specification stated at [0192] that:
Persons skilled in the art will appreciate that numerous variations and modifications will become apparent. All such variations and modifications which become apparent to persons skilled in the art, should be considered to fall within the spirit and scope that the invention broadly appearing before described. Thus, for example, it will be appreciated that features from different examples above may be used interchangeably where appropriate.
73 The Patent has two independent claims. Independent claim 1 provides (with the integers identified for convenience):
1.1 An apparatus for use in assessing strength of at least one knee flexor muscle of a subject, the apparatus including:
1.2 two securing members;
1.3 each securing member being configured to secure a respective lower leg of the subject in a position that, in use, is substantially fixed relative to a support when the subject lowers the subject’s upper body from a kneeling position to perform an eccentric contraction of the at least one knee flexor muscle of the subject; and
1.4 at least one sensor coupled to at least one of the securing members;
1.5 to sense a force applied to the at least one securing member by the subject’s knee flexor muscle acting in eccentric contraction while the subject lowers the subject’s upper body, the force being indicative of the strength of the at least one knee flexor muscle acting in eccentric contraction.
74 Independent claim 18 provides (with the integers identified for convenience):
18.1 A method of assessing strength of at least one knee flexor muscle of a subject using an apparatus including:
18.2 two securing members; and
18.3 at least one sensor coupled to at least one of the two securing members;
18.4 the method including securing the lower legs of the subject, using the respective securing members, in a position that is substantially fixed relative to the support when the subject lowers the subject’s upper body from a kneeling position to perform an eccentric contraction; and
18.5 sensing, with the, or each, sensor a force applied to at least one of the securing members by the at least one knee flexor muscle acting in eccentric contraction while the subject lowers the subject’s upper body from the kneeling position to perform an eccentric contraction of the at least one knee flexor muscle while the subject’s lower legs are secured to the respective securing members, which force is indicative of the strength of the at least one knee flexor muscle.
75 The claims which are dependent on claim 1 are as follows:
(1) Claim 2: The apparatus according to claim 1, wherein the at least one sensor is coupled to the at least one of the two securing members;
(2) Claim 3: The apparatus according to claim 1 or 2, wherein the at least one sensor includes two sensors, each sensor being coupled to a respective securing member to sense the force indicative of the strength of the at least one knee flexor muscle in each leg of the subject;
(3) Claim 4: The apparatus according to any one of the preceding claims, wherein the securing members are movably mounted to the support;
(4) Claim 5: The apparatus according to any one of the preceding claims, wherein the securing members include any one of a strap, a cuff and a tie;
(5) Claim 6: The apparatus according to any one of the preceding claims, which includes at least one knee support that, in use, supports at least one knee of the subject;
(6) Claim 7: The apparatus according to any one of the preceding claims, wherein the sensors are configured to sense the force indicative of the strength of the at least one knee flexor muscle in each leg of the subject simultaneously;
(7) Claim 8: The apparatus according to any one of claims 1 to 6, wherein the sensors are configured to sense the force indicative of the strength of the at least one knee flexor muscle in each leg of the subject at different times;
(8) Claim 9: The apparatus according to any one of the preceding claims, wherein the apparatus includes an electronic processing device for monitoring signals from the at least one sensor and generating, at least in part using the signals, an indicator indicative of a strength of the at least one knee flexor muscle of the subject;
(9) Claim 10: The apparatus according to claim 9, wherein the indicator is indicative of at least one of an instantaneous force, a rate of force development, an average force, a peak force, an impulse, work, an instantaneous torque, a rate of torque development, an average torque, changes in force over time, changes in torque over time, and a peak torque;
(10) Claim 11: The apparatus according to claim 9 or 10, wherein the electronic processing device is configured to compare the signals, at least in part, and reference data, and to generate the indicator in accordance with the results of the comparison;
(11) Claim 12: The apparatus according to claim 11, wherein the reference data includes at least one of a tolerance determined from a normal population, a predetermined range, a predetermined reference, a previously generated indicator and an indicator generated for another leg;
(12) Claim 13: The apparatus according to claim 11 or 12, wherein the indicator is indicative of the signals, at least in part, and the reference data, and a difference between the signals, at least in part, and the reference data;
(13) Claim 14: The apparatus according to any one of claims 9 to 13, wherein the apparatus includes an output for presenting at least the indicator to the user;
(14) Claim 15: The apparatus according to any one of the preceding claims, wherein the apparatus includes an input, thereby allowing a user to input data;
(15) Claim 16: The apparatus according to any one of the preceding claims, wherein the support is elongated and wherein the securing members are provided at a first end of the support and a second end of the support is configured to support a weight of the subject;
(16) Claim 17: The apparatus according to any one of the preceding claims, wherein the sensor includes any one of a load cell, a force plate, a piezoresistive force sensor, a strain gauge and a hydraulic pressure gauge, the sensor being configured to sense any one of compression and tension.
76 Claim 19 is dependent on claim 18. It states:
The method according to claim 18, which includes monitoring signals from the at least one sensor and generating, at least in part using the signals, an indicator indicative of the strength of the at least one knee flexor muscle.
77 Claim 20 is also dependent on claim 18. It states:
The method according to claim 19, the method including comparing the signals, at least in part, and reference data, and generating the indicator in accordance with the results of the comparison.
78 The person skilled in the art is the hypothetical person to whom the patent specification is addressed and who, generally speaking, works in the art or science with which the invention is connected: see, e.g., Root Quality Pty Ltd v Root Control Technologies Pty Ltd (2000) 49 IPR 225; [2000] FCA 980 at [70]–[71] (Finkelstein J). It is not a reference to a specific person but is a legal construct or notional person who may have an interest in using the products or methods of the invention, making the products of the invention, or making products used to carry out the methods of the invention either alone or in collaboration with others having such an interest: Aristocrat Technologies Australia Pty Ltd v Konami Australia Pty Ltd (2015) 114 IPR 28; [2015] FCA 735 at [26] (Nicholas J); Hanwha Solutions Corporation v REC Solar Pte Ltd [2023] FCA 1017 at [86] (Burley J).
79 Based on the subject matter of the Patent, the person skilled in the art has skills (at least) in sports medicine, being a person with knowledge of and familiarity with exercise and training apparatus (for example, as a physiotherapist or sports scientist). There was no dispute in this case that both experts had such expertise.
80 The focus of the construction debate concerned claim 1 of the Patent. To the extent that there was a dispute concerning other claims (namely 4 and 16), that debate will be addressed as part of the reasons relating to infringement.
81 The principles of claim construction are not relevantly in dispute and are conveniently set out in Jupiters Ltd v Neurizon Pty Ltd (2005) 65 IPR 86; [2005] FCAFC 90 at [67] (Hill, Finn and Gyles JJ) as follows:
(i) the proper construction of a specification is a matter of law: Décor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385 at 400;
(ii) a patent specification should be given a purposive, not a purely literal, construction: Flexible Steel Lacing Company v Beltreco Ltd (2000) 49 IPR 331; [2000] FCA 890 at [81] (Flexible Steel Lacing); and it is not to be read in the abstract but is to be construed in the light of the common general knowledge and the art before the priority date: Kimberley-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1; 177 ALR 460; 50 IPR 513; [2001] HCA 8 at [24];
(iii) the words used in a specification are to be given the meaning which the normal person skilled in the art would attach to them, having regard to his or her own general knowledge and to what is disclosed in the body of the specification: Décor Corporation Pty Ltd at 391;
(iv) while the claims are to be construed in the context of the specification as a whole, it is not legitimate to narrow or expand the boundaries of monopoly as fixed by the words of a claim by adding to those words glosses drawn from other parts of the specification, although terms in the claim which are unclear may be defined by reference to the body of the specification: Kimberley-Clark v Arico at [15]; Welch Perrin & Co Pty Ltd v Worrel (1961) 106 CLR 588 at 610; Interlego AG v Toltoys Pty Ltd (1973) 130 CLR 461 at 478; the body of a specification cannot be used to change a clear claim for one subject matter into a claim for another and different subject matter: Electric & Musical Industries Ltd v Lissen Ltd [1938] 4 All ER 221 at 224–5; (1938) 56 RPC 23 at 39;
(v) experts can give evidence on the meaning which those skilled in the art would give to technical or scientific terms and phrases and on unusual or special meanings to be given by skilled addressees to words which might otherwise bear their ordinary meaning: Sartas No 1 Pty Ltd v Koukourou & Partners Pty Ltd (1994) 30 IPR 479 at 485–6 (Sartas No 1 Pty Ltd); the Court is to place itself in the position of some person acquainted with the surrounding circumstances as to the state of the art and manufacture at the time (Kimberley-Clark v Arico at [24]); and
(vi) it is for the Court, not for any witness however expert, to construe the specification; Sartas No 1 Pty Ltd at 485–6.
82 As point (iv) in the summary in Jupiters makes clear, the claims are to be read in the context of the specification as a whole. However, balanced against that is the requirement that the body of a specification cannot be used to change a clear claim for one subject matter into a claim for another different subject matter. Put another way, the correct approach to construction is to read the document in its context, including the claims: see Fresenius Medical Care Australia Pty Ltd v Gambro Pty Ltd (2005) 67 IPR 230; [2005] FCAFC 220 at [44], [94] (Wilcox, Branson and Bennett JJ).
83 It is for the Court to determine the meaning of the language of the claims, aided by the evidence of experts to assist in understanding unfamiliar terms and the technical context of the subject matter. Expert opinion does not supplant the judicial role: see Airco Fasteners Pty Ltd v Illinois Tool Works Inc (2023) 170 IPR 225; [2023] FCAFC 7 at [59] (Rares, Moshinsky and Burley JJ).
5.2 Whether claims require assessment of strength in reliable and accurate way
84 The first issue concerns whether the claims require the assessment of the strength of a knee flexor muscle in a reliable and accurate way to provide clinically relevant information (KangaTech’s characterisation of the issue) or whether the claims require perfect or even near perfect accuracy or reliability in assessing such strength (Vald’s characterisation of the issue). However, the latter characterisation overstates KangaTech’s position on this issue.
85 By its opening submissions on infringement, KangaTech did not refer to perfection, instead submitting that:
…the disclosure of the invention, including the apparatus, is always conditioned by reference to its use in effectively and reliably assessing the strength of at least one knee flexor muscle by the user performing an NHE.
86 Although complaint was made by Vald that this construction issue was not raised by KangaTech through its pleadings, it was opened by KangaTech both orally (for example, at T44/10–45) and in writing as set out above, and without objection by Vald. As addressed in more detail below, the experts addressed issues relating to reliability and accuracy, including in the JER. Further, Vald sought a finding that the force measurement from unilateral Nordic curls is sufficiently reliable. Finally, Vald addressed this construction issue in its closing submissions, both orally in and writing. Specifically, by reference to its characterisation of the issue above, Vald submits that:
(1) The claims do not specifically refer to reliability or accuracy, let alone quantitative thresholds thereof. See also e.g., Lovell T301.19-37 and cf T69.17-20.
(2) Neither the claim nor the specification requires any specific duration of descent. See also e.g., Lovell T300.39-301.19.
(3) The Patent is aimed at something that is “a bit more functional” than an ISD; i.e., “easier to test multiple athletes, but not quite as controlled”: Lovell T293.46-3.
87 Although the claims do not refer to reliability or accuracy expressly, integer 1.1 describes the apparatus as one “for use in assessing strength of at least one knee flexor muscle of a subject”. Integer 1.5 describes a force being sensed which is “indicative of the strength” of at least one knee flexor muscle acting in eccentric contraction.
88 Similarly, integer 18.1 describes the method as one of “assessing strength of at least one knee flexor muscle of a subject using an apparatus”. Integer 18.5 describes a force being sensed which is “indicative of the strength” of at least one knee flexor muscle acting in eccentric contraction.
89 The Patent discloses that the result which is achieved by the assessments of strength conducted by the disclosed apparatus and method are accurate and reliable in that:
(1) the apparatus overcomes disadvantages of existing techniques which were known as at the priority date, which are said to have “questionable reliability and repeatability of measurements of between limb strength imbalances” and the apparatus “appears to provide enhanced sensitivity and reliability for the assessment of between limb strength imbalances compared to existing techniques”: [0012], [0079];
(2) the apparatus “displays acceptable levels of test-retest reliability when measuring peak or average peak knee flexor force during a bilateral NHE”: [0179];
(3) the apparatus displays acceptable reliability for “the measurement of between limb strength differences” when the NHE was “completed bilaterally, and peak force was average across six contractions”: [0179];
(4) “a bilateral NHE performed with multiple repetitions across a number of sets to determine average eccentric peak knee flexor force produces optimal reliability”: [0179];
(5) “the apparatus 100 is capable of effectively assessing the hamstring strength of a subject S, and in particular displays acceptable levels of test-retest reliability and correlation with gold standard, i.e. isokinetic dynamometry, assessments”: [0189].
90 In circumstances where the person skilled in the art has skills in sports medicine, the purposive, common-sense construction of the claims is that they describe an apparatus (claim 1 and its dependent claims) and a method (claim 18 and its dependent claims) which can be used to assess strength of at least one knee flexor muscle of a subject in a reliable and accurate way in order to provide clinically relevant information.
91 In other words, in construing the claims in the context of the specification as a whole (as addressed above), a person skilled in the art would understand the reference to an apparatus for use in assessing strength of at least one knee flexor muscle of a subject in integer 1.1, or to a method of assessing strength of at least one knee flexor muscle of a subject using an apparatus in integer 18.1, as only being capable of achieving that result if that assessment is a reliable and accurate one.
92 Dr Lovell’s commentary around what the claims and the specification do, or do not, contain (as highlighted in Vald’s closing submissions) does not detract from this conclusion.
5.3 Whether claim 1 requires both legs to be secured
93 A central issue in this case is whether claim 1 requires that both legs be secured in the securing members (KangaTech’s construction) or whether claim 1 requires that either one or both legs be so secured (Vald’s construction).
94 Claim 1 refers to two securing members, each securing member being configured to secure a respective lower leg of the subject in a position that, in use, is substantially fixed relative to a support when the subject lowers the subject’s upper body from a kneeling position to perform an eccentric contraction of the at least one knee flexor muscle of the subject (integers 1.2 and 1.3).
95 In support of its construction, Vald submits, and I accept, that the word “configured” in claim 1 is not a word which has a technical meaning and nor is it a word to which the specification ascribes a special meaning. The ordinary meaning of the word “configured” means “designed or adapted to form a desired configuration”.
96 Vald also contrasts the words of claim 1 to that of claim 18, which is a method claim and which it submits requires a performative action, that is, “securing the lower legs of the subject, using the respective securing members” (emphasis added).
97 Finally, Vald cites s 116 of the Patents Act and observes that the reference to “securing” was contained in the original version of claim 1 but that this was amended as follows (with the mark up showing the amendments):
two securing members, each securing member securing being configured to secure a respective lower leg of the subject in a position that, in use, is substantially fixed relative to the support when the subject lowers the subject’s upper body from a kneeling position to perform an eccentric contraction of the at least one knee flexor muscle of the subject.
98 However, notwithstanding these matters, the proper construction of claim 1, when read in the context of the specification as a whole (rather than selected parts of it), is that both legs must be secured in the securing members.
99 That is for the following reasons.
100 The “Background of the Invention” describes the invention as being an apparatus for use in assessing the strength of at least one knee flexor muscle of a subject. The reference to at least one knee flexor muscle being tested, even if that muscle is only tested in one but not both legs, does not have the consequence that only one leg is secured for the purpose of testing that knee flexor muscle. That is made plain by, for example, [0038] and [0039] of the specification.
101 The “Background of the Invention” then states to the effect that, in one example, the invention relates to an apparatus for use in assessing at least the hamstring strength in at least one leg of the subject while the subject performs an eccentric knee flexor contraction. While the superficial impression of these words is that only one leg is secured (the hamstring strength of which is being tested), it will be seen that the Patent contemplates the testing of only one leg using one sensor, with the other leg being secured but not tested.
102 As observed above, the specification refers to existing devices, including the “gold standard” isokinetic dynamometer, which device assesses the strength in each leg independently (one leg at a time), with the specification stating that this requires “significant time”: [0005].
103 At [0012], the specification reiterates that a disadvantage of existing devices is “significant assessment times” and further states that, “previous methods and apparatus have failed to provide simultaneous assessment of hamstring strength in both legs, independently, during a bilateral exercise, or a combined assessment of hamstring strength in both legs during a bilateral exercise” (emphasis added). No mention is made of deficiencies in existing devices by reference to unilateral exercises.
104 Further, taking into account the emphasis in [0005] and [0012] upon the undue length of assessment times where each leg is tested one at a time (particularly through use of the isokinetic dynamometer), the solution which is proffered by the Patent is an apparatus which permits the hamstring strength in both legs to be tested at the same time, either independently or on a combined basis, thereby reducing the assessment time. If the apparatus was one which tested the hamstring strength of one leg at a time (which would be the case if only one leg was secured), this would not reduce the assessment time, and would not be regarded as overcoming the perceived disadvantage of existing devices.
105 In the “Summary of the Present Invention”, the specification reveals that the invention seeks to ameliorate “one or more” of the abovementioned problems. It goes on to describe the invention in three broad forms at [0014], [0040] and [0041]. Each of these broad forms or consistory clauses contains wording which indicates that both legs are secured by the securing members, namely:
(1) “two securing members, each securing member securing a respective lower leg of the subject…”: [0014];
(2) “two securing members, each securing member constraining movement of a respective lower leg of the subject…”: [0040];
(3) “securing two lower legs of a subject using the respective securing members…”: [0041].
106 There is nothing in the part of the specification described as the “Summary of the Present Invention” which contemplates that only one leg is secured by a securing member. If this was contemplated, one would expect to see at least some reference to it here.
107 Each of the consistory clauses also refers to the apparatus having “at least one sensor” which is then described as, in effect, sensing a force indicative of the strength of at least one knee flexor muscle in at least one leg. However, the reference to and use of only one sensor does not mean that only one leg is secured; it simply means that a knee flexor muscle of one of the two secured legs is being assessed by that one sensor when the bilateral Nordic curl is performed using the apparatus.
108 This construction is supported by [0015] (for example), where reference is made to at least one sensor being coupled to at least one of the two securing members. It is also supported by the words used in the consistory clauses such as [0014] which provides:
at least one sensor, which in use senses a force indicative of the strength of the at least one knee flexor muscle in at least one leg of the subject while the subject performs an eccentric contraction of the at least one knee flexor muscle.
109 Further support for this construction is found at (for example) [0044] which provides that: “Typically the method includes sensing the force indicative of the hamstring strength in at least one leg of the subject while the subject performs a Nordic hamstring exercise”. This paragraph is connected with the third broad form which is in turn the consistory clause of claim 18 (the method claim) which Vald accepts requires both legs to be secured. Yet [0044] refers to sensing the force indicative of the hamstring strength in at least one leg of the subject. Although only one leg is referred to in [0044] as being tested, both legs are secured using the method described in [0041].
110 An example of the invention is then described with reference to the drawings. Figures 1D, 1E and 1F are shown above. At [0050], these drawings are described as schematic drawings of a first example of a subject performing an eccentric contraction of at least a knee flexor using the apparatus.
111 The Detailed Description of the Preferred Embodiments provides an example of the apparatus by reference to Figures 1A to 1F.
112 As already identified above, the specification then states:
[0072] In this example, the apparatus 100 includes a support 110, and two securing members 121, 122, that in use secure a respective lower leg of the subject S in a position that is substantially fixed relative to the support 110.
[0073] The apparatus 100 further includes two sensors 130.1, 130.2 that, in use, sense a force indicative of the strength of at least one knee flexor muscle in one or both legs of the subject S while the subject S performs an eccentric contraction of the at least one knee flexor muscle.
113 Pausing there, although the words refer to an eccentric contraction of the at least one knee flexor muscle, the description refers to an example shown in drawings which depict the apparatus being used with both legs secured by the securing members.
114 At [0075], it is stated that:
Figures 1D to 1F show a subject S performing an eccentric contraction of at least a hamstring using the apparatus 100. In this respect, Figure 1D shows the subject S in an initial kneeling position prior to commencing the contraction, in which the subject's lower legs are secured using the respective securing members 121, 122 in a position that in use is substantially fixed relative to the support. The subject S subsequently proceeds to lower their upper body toward the support 110 in a controlled manner, while substantially maintaining alignment of the upper legs or thighs and torso, as shown in Figure 1E. Figure 1F shows a final position, with the subject S laying substantially prone on the support 110. It will be appreciated that the abovementioned eccentric contraction is typically called the 'Nordic hamstring exercise', 'Nordic curl', or the like.
(Emphasis added.)
115 There is no drawing which depicts, and nor does the specification identify, how the subject S lowers their upper body toward the support 110 in a controlled manner, while substantially maintaining alignment of the upper legs or thighs and torso, if only one leg is secured in a securing member.
116 At [0076], it is stated that:
Accordingly, the above-described arrangement provides apparatus 100 for use in assessing hamstring strength of a subject S, in which the force exerted at the lower leg of the subject S while they perform an eccentric contraction of at least the hamstring is indicative of hamstring strength. …
117 Again, the advantage of the apparatus over the existing methods is emphasised at [0079] by reference to the fact that each leg may be tested at the same time, as follows:
It will also be appreciated that the apparatus 100 including two sensors 130.1, 130.2 allows the assessment of the hamstring strength of both hamstrings of a subject S, at the same time. Accordingly the sensors 130.1, 130.2 may sense the force indicative of at least the hamstring strength in each leg of the subject S simultaneously. In this regard, the assessment may be performed in significantly less time than existing methods, for example isokinetic dynamometry, which is limited to assessing hamstrings of opposing legs at different times. …
118 At [0083], it is stated that a number of further features will now be described. At [0084] and [0085], the following is then stated:
[0084] In another example, each sensor 130.1, 130.2 is coupled to a respective securing member 121, 122 that secures the ankles of a subject S relative to the support 110 and accordingly the force sensed at the ankles is indicative of hamstring strength. However, this feature is not essential and it will be appreciated that the sensors 130.1, 130.2 may sense a force exerted at any part of the lower leg, for example under the knees of the subject S.
[0085] Furthermore, the assessment of hamstring strength may occur during a unilateral or bilateral contraction/s of the hamstring/s. For example, during a bilateral contraction, two sensors 130.1, 130.2 may be used to sense the force in each leg of the subject simultaneously or at different times, or alternatively a single sensor 130.1, 130.2 may be used to sense the force in either or both legs. During a unilateral contraction, the apparatus may include one sensor 130.1, 130.2 which is interchangeable between the lower legs of the subject, by repositioning the sensor 130.1, 130.2 and/or the securing members 121, 122 and/or the subject S relative to the support 110, such that the hamstring strength in both legs can be assessed sequentially. However, this feature is not essential.
(Emphasis added.)
119 Dr Pizzari’s evidence (both affidavit and oral evidence) concerning the construction of the Patent (which favoured Vald) was centred upon [0085] of the specification in particular.
120 In reliance upon Dr Pizzari’s evidence, Vald points to the emphasised words in [0085] to contend that claim 1 should not be construed as requiring both legs to be secured by the securing members on the basis that a person skilled in the art as at the priority date would know that, in order to perform a unilateral contraction of the hamstring, one leg must be unsecured.
121 However, I do not accept this submission having regard to my finding as to the common general knowledge as at the priority date.
122 My view as to the proper construction of claim 1 aligns with that of Dr Lovell, whose evidence I prefer to that of Dr Pizzari for the reasons already stated. Dr Lovell gave the following evidence in his first affidavit (which evidence I accept):
111. In my opinion, none of the claims of the Patent encompass a subject performing an NHE with only one lower leg secured. While there are references to testing ‘at least one knee flexor’, I read this as meaning the force generated by only a single leg may be measured but that both the subject’s lower legs are both secured in their respective securing members.
112. My understanding of the apparatus described and claimed in the Patent is that it encompasses:
• an apparatus where the subject has both their legs secured (i.e., fixed relative to the support (platform);
• An NHE is performed to cause an eccentric contraction of at least one hamstring (knee flexor) – that eccentric contraction being necessary to resist the subject’s upper body falling forward; and
• The force which the subject leaning forward – and the resultant eccentric contraction generates – being measured in one or both legs – via a sensor (or sensors) connected to the securing member(s).
…
114. While there is no specific reference to the contralateral leg (being the leg for which force is not being measured) being secured, in my opinion that leg must also be secured for stability purposes.
115. In my opinion, the stability required to perform an NHE in a way which would produce any useful form of measurement in one leg, would require that the other ‘contralateral’ lower limb – being the leg for which no force measurement was being taken – was supported and/or restrained or otherwise stabilised by some form of support, platform or restraint.
…
121. While, at paragraph 173, the Patent refers to the performance of “unilateral contractions” and NHEs being performed “unilaterally”, it is unclear to me whether this is referring to unilateral measurements (i.e. measuring the force exerted in one leg whilst the other leg remains secured) or that it contemplates a one-legged Nordic curl being performed. To the extent that it is the latter, the Patent does not explain how this is done and the drawings do not depict this activity. Accordingly, while the Patent refers to both bilateral and unilateral NHE’s, it does not explain how a unilateral NHE is performed and measured in any meaningful way.
122. …Furthermore, any force results obtained in carrying out [a one-legged NHE] would, in my view be of very limited value.
(Emphasis original.)
123 An additional reason in support of my construction rests upon my finding that claim 1 requires the apparatus to assess strength in a reliable and accurate way to provide clinically relevant information. That is because, based upon Dr Lovell’s evidence as follows (which evidence I accept), such an assessment is not achieved when a unilateral NHE is performed on the apparatus disclosed in claim 1. Dr Lovell explained in his first affidavit that:
[P]erforming an NHE in the way outlined above, with one leg restrained and the other stabilised, supported or held in a different manner, would compromise the accuracy of the assessment as the contralateral limb (i.e., the limb not restrained in the same way) would inevitably be absorbing a proportion of the force generated in performing an NHE but that force would not be measured in any way.
124 Returning then to the Patent itself, there are many strong indicators within it that Vald’s construction is not the correct one. Some of these have already been addressed above. Others will now be considered.
125 Use of the apparatus with only one leg secured by a securing member is not depicted in any of the drawings, and [0085] does not state in express terms that only one ankle or one leg of the subject is secured (unlike other paragraphs in the specification which refer expressly to the ankles or legs of the subject being secured, such as [0075], [0081] and [0084]). Nor does the specification (whether through any drawing or otherwise) describe where the unsecured leg is to be placed (for example) or, as already observed, how the subject S lowers their upper body toward the support 110 in a controlled manner, while substantially maintaining alignment of the upper legs or thighs and torso, if only one leg is secured in a securing member.
126 The specification is detailed in its description of the different means of using the apparatus with both legs secured, including by reference to numerous drawings, but is silent as to how this is to be achieved with only one leg secured. These matters tell against a construction of claim 1 which does not require both legs to be secured. If it was a simple matter of informing the person skilled in the art to perform a bilateral Nordic curl on the apparatus and leaving it to them to understand how to undertake that process, these details and drawings would not be required. Having regard to the evidence of Dr Lovell, a unilateral Nordic curl is more difficult for a person to perform, and there are impediments to obtaining a reliable force measurement from such an exercise without the use of a support. This makes it more, not less, likely that there would be an explanation in the specification about the manner of performing a strength assessment on the apparatus with only one leg secured if claim 1 encompassed that.
127 This is especially as one of the advantages which the Patent holds the apparatus out as having is better reliability and repeatability of measurements of between limb strength imbalances. It is to the issue of reliability that I now turn.
128 At [0012] of the specification, after addressing existing methods and devices for testing hamstring strength, the specification identifies that existing techniques have questionable reliability and repeatability of measurements of between limb strength imbalances.
129 In the Detailed Description of the Preferred Embodiments at [0079], it is stated that the apparatus also appears to provide enhanced sensitivity and reliability for the assessment of between limb strength imbalances compared to existing techniques.
130 At [0170], it is stated that, “A number of experiments were performed in order to demonstrate the effectiveness of the abovementioned apparatus 100…”.
131 The section which follows is entitled “Reliability and Validity Experiments” and appears at [0171]–[0182] of the specification.
132 These experiments involved 30 subjects (initially 31, but one was excluded). One session involved the determination of eccentric knee flexor strength via isokinetic dynamometry and the apparatus, and another session involved the assessment of eccentric knee flexor force via the apparatus only, to allow for test-retest reliability to be determined. Participants were asked to perform two sets of “three maximal NHEs bilaterally (with both legs) and unilaterally (using only one leg)”.
133 The specification identified at [0177] that:
(1) on the whole absolute force measurements taken during bilateral contractions were more reliable than the unilateral contractions;
(2) with respect to between limb imbalances in force, only the bilateral average peak force condition displayed acceptable reliability.
134 The specification then continued as follows:
[0179] From the data presented, the apparatus 100 displays acceptable levels of test-retest reliability when measuring peak or average peak knee flexor force during a bilateral NHE and approaches an acceptable level of reliability for average peak force during unilateral contractions. For the measurement of between limb strength differences, only when the NHE was completed bilaterally, and peak force was average across six contractions, did the measure display acceptable reliability. Hence, the findings from the current study suggests that the single most reliable method to acquire eccentric knee flexor force and between limb force ratios from the apparatus 100 is via a bilateral NHE with peak force averaged across six contractions. There is also the capability to assess eccentric knee flexor strength during a bilateral contraction but using a single peak measure instead of an average of peak forces, or during unilateral contraction, however the between limb strength comparisons, and in some cases the absolute force measures, do not appear to be reliable for these methods. Therefore, it appears that a bilateral NHE performed with multiple repetitions across a number of sets to determine average eccentric peak knee flexor force produces optimal reliability. For the purposes of maximal strength assessment it is important to minimise the number of repetitions per set to reduce the impact of fatigue throughout a set because this will have a significant impact on average peak force. In the current study two sets of three repetitions were performed, but similar set and repetition formats (i.e. three sets of two repetitions) are also feasible. It is also recommend [sic] that measures of eccentric knee flexor strength and between limb strength imbalances be used to compare within but not between athletes. This is due to the varying factors which influence the performance of the NHE, such as lever lengths and upper body mass that would differ markedly between athletes, but would be expected to remain mostly similar within an athlete.
…
[0181] It might also be expected that the difference in laterality between the bilateral NHE and the unilateral dynamometry testing would contribute to some of the variability, however on the whole, the unilateral NHE displayed weaker correlations than the bilateral contractions. This may be due in part to the difficulty participants experienced in becoming comfortable with the unilateral condition, as exemplified by the greater amount of familiarisation time that was required to be devoted to the unilateral contractions.
[0182] Aside from the bilateral NHE condition displaying the highest level of test-retest reliability, the ability to assess unilateral eccentric knee flexor strength during bilateral contractions may have additional benefits. It is well known that there are complexities in the neural control of bilateral and unilateral contractions, with the bilateral deficit a primary example of such a phenomenon. It would appear feasible that under bilateral conditions, in a task with a known but ever increasing load such as the NHE, the nervous system may elect to protect a weaker or more vulnerable muscle/limb and consequently chose to ‘load’ the more capable muscle or limb more aggressively. As such bilateral testing may be better able to detect between limb strength imbalances, if they exist, compared with unilateral strength assessments which have already shown some predictive ability. This is particularly pertinent for the monitoring of HSI risk in athletes, given between limb strength difference have been reported to increase the risk of injury in athletes. Indeed, unpublished observations show that in elite athletes with a previous unilateral HSI history, the apparatus 100 has been able to better predict the previously injured limb compared to the isokinetic dynamometer, based on between limb eccentric strength deficits.
(Emphasis added.)
135 The specification next addresses the results of what is described as an “Intervention Experiment” which was performed using the apparatus, with the participants’ eccentric knee flexor strength measured using the apparatus by performing two sets of two bilateral NHEs on the apparatus both prior to and following the completion of the intervention. At [0185], it is stated that the apparatus can reliably detect improvements in hamstring strength over a period of training.
136 The specification then addresses what are described as “Injured Cross-sectional Experiments” which involved participants with clinically diagnosed unilateral hamstring strain injury. The participants performed two sets of two bilateral NHEs on the apparatus to determine eccentric knee flexor strength for both the injured and uninjured limb, and then further tests were performed. At [0187], the results are stated as being that the previously injured limb was significantly weaker than the uninjured limb.
137 At [0189], it is stated that, in view of these experiments, it will be appreciated that the apparatus is capable of effectively assessing the hamstring strength of a subject, and in particular displays acceptable levels of test-retest reliability and correlation with gold standard, i.e. isokinetic dynamometry assessments. It also states that the apparatus displays promising results in intervention and cross-sectional injury investigations.
138 Having regard to the earlier sections of the specification which precede the conclusions at [0189], as set out above, these conclusions relate only to the performance of bilateral NHEs on the apparatus. As it was common ground between the experts that a unilateral NHE could not be performed on the apparatus if both legs were secured by the securing members, which evidence I accept, it follows that these conclusions are directed to use of the apparatus in which both legs are secured by the securing members.
139 There are no similar conclusions which are referable to the performance of unilateral NHEs on the apparatus (being with only one leg secured). Rather, the results of the testing demonstrate that either the performance of unilateral NHEs on the apparatus did not display acceptable reliability with respect to limb imbalances in average peak force condition ([0177]), only approached (but I interpret, did not achieve) an acceptable level of test-retest reliability for average peak force ([0179]) and displayed weaker correlations with isokinetic dynamometry assessments ([0181]).
140 The conclusions at [0189] are an echo of the identified issues with the prior art at [0012] being “questionable reliability and repeatability of measurements of between limb strength imbalances”. Having commenced with identification of the problems with existing devices and methods, the specification then seeks to demonstrate that the performance of bilateral NHEs on the apparatus has overcome these problems through the experiments conducted on the apparatus.
141 At [0190], the specification again highlights the decreased assessment times as compared to the isokinetic dynamometer, being something which is achieved by assessing the hamstring strength of each leg simultaneously (through a bilateral Nordic curl), rather than one leg at a time such as occurs when using the isokinetic dynamometer.
142 For these reasons, the Patent teaches away from unilateral Nordic curls being performed on the apparatus, being the use of the apparatus with only one leg secured by a securing member.
5.4 Whether claim 1 is a product or method claim
143 A further issue of construction related to the proper characterisation of claim 1, being whether it is a product claim limited by result (as contended by Vald) or whether it is, as KangaTech contended, “not a true product claim” and thus, in effect, a “disguised” method or process claim.
5.4.1 The contentions by the parties
144 In summary, Vald submits that:
(1) in a product claim, the claimed product “is defined only by features describing the product itself, e.g. by reference to its properties, capabilities, materials, parts and their interrelationship, etc”: Foxtel Management Pty Ltd v Advanced Technology Group Pty Ltd (2021) 166 IPR 632; [2021] APO 36 at [37], cited with approval in Bodkin C, Patent Law in Australia (Thomson, Westlaw) at [41100];
(2) in contrast, a claim referring to a product is a method claim where the product is required in the actual performance of an action (as distinct from the “mere capability of the product to perform the action”): Foxtel at [37].
145 Vald submits that claim 1 does not require the actual performance of an action (which would be the subject of a method claim). Vald further submits that it is permissible for a product claim to “define the physical characteristics of the article by a suitable reference to the results which it is to achieve”: Mullard Radio Valve Co Ltd v British Belmont Radio Ltd (1939) 56 RPC 1 at 10 (Greene MR), quoted with approval in Axent Holdings Pty Ltd v Compusign Australia Pty Ltd (2020) 154 IPR 431; [2020] FCA 1373 at [264] (Kenny J). It submits that doing so does not convert a product claim into a method claim, relying on Axent at [265], [269], [270] and [275].
146 In summary, KangaTech submits that:
(1) following “the introductory chapeau to claim 1”, the apparatus, in use, is further defined in claim 1 by the integers which do not define structural or functional limitations of an apparatus but rather the actions that the user must take in relation to the apparatus to assess the strength of at least one knee flexor muscle of a subject. The use is also defined by the functional requirement that the force generated by the actions is indicative of the strength of at least one of the knee flexor muscles (emphasis in submissions);
(2) central to Vald’s construction of claim 1 (and its dependencies) is an assertion that only the structural features of claim 1 should be given meaning and that Vald “seeks to construe claim 1 to remove any of the integers conditioning the use of the apparatus”;
(3) the practical consequence of Vald’s construction is that claim 1 would encompass any apparatus that had two securing members fixed to a support, and at least one sensor coupled to a securing member, irrespective of how such an apparatus may be used;
(4) the wording of claim 1 should be given meaning, which wording conditions the suitability for use of the apparatus to assess the strength of at least one knee flexor muscle;
(5) claim 1 includes a definition of a product; however, it is further limited by particular actions to be performed and the forces measured as a result of those actions;
(6) Vald’s construction is entirely inconsistent with the disclosure of the invention in the Patent. The disclosure of the invention, including the apparatus, is always conditioned by reference to its use in accurately and reliably assessing the strength of at least one knee flexor muscle by the user performing an NHE. The Patent does not characterise the inventive concept as attaching sensors to an apparatus. It is apparent from the evidence that that was well known at the priority date.
147 In D’Arcy v Myriad Genetics Inc (2015) 258 CLR 334; [2015] HCA 35 at [145], Gageler J (as his Honour then was) and Nettle J observed that:
…More generally, an “invention is to be understood as a matter of substance and not merely as a matter of form”. If a claim drafted as a product claim is in truth a “disguised” process claim, it will be treated as such.
(Citations omitted.)
148 In Axent, Kenny J observed at [262] and [263] that:
…the authorities draw a distinction between a product claim containing a limitation by result (or functionality limitation) and a method (or process) claim. In Blanco White’s Patents for Inventions and the Protection of Industrial Designs (5th ed, 1983) (Blanco White) at 4–413, the author stated:
To amount to a limitation by result, what is in the claim must at least be a limitation: something that draws a line between two classes of things that would otherwise fall within the claim: with the implication that conditions of the manufacture can be adjusted, by the reader of the specification, to secure the specified result. It is, of course, a matter of construction to determine whether words in the claim effect a limitation or merely assert that complying with the claim will secure a certain result, and this like other questions of construction affecting validity is likely in present-day conditions to be decided in favour of an otherwise meritorious patentee.
A claim will be construed as a method or process claim if it employs a method of definition appropriate only to a method or process claim: see Rescare Ltd v Anaesthetic Supplies Pty Ltd (1992) 111 ALR 205; 25 IPR 119 at 126, citing Mullard Radio Valve Co Ltd v British Belmont Radio Ltd (1938) 56 RPC 1, at 10–11.
(Emphasis omitted.)
149 In Mullard at page 10, Sir Wilfrid Greene, M.R. (as his Lordship then was) stated:
Unlike Claim 1, which is a process claim, the amended Claim 2 is, as was the original Claim 2, an apparatus claim and it must stand or fall as such. In such a claim it is permissible in a proper case to define the physical characteristics of the article by a suitable reference to the results which it is to achieve. It is no objection to such a method of definition in cases where it is appropriate that experiment may be required in order that a worker in the art may know whether an article which he has made does or does not infringe the patent. A permissible reference to results is in truth as much a description of the physical characteristics of the article as a reference to its size or strength or chemical composition would be, and in many cases such a reference is the only practical method of describing the article or some characteristic which it possesses. On the other hand, it is not permissible to import into an apparatus claim a method of definition which is appropriate only to a process claim. Thus an article which is not in itself patentable cannot be made the subject of a good apparatus claim merely by pointing out that, if it is used in a particular way or in a particular collocation, it will produce novel and useful results. This does not, of course, mean that there may not be a patentable piece of apparatus in which such an article forms one element, for the combination of the article with other elements may be novel and useful and may require an exercise of the inventive faculty to produce it. Nor does it mean that there cannot be a good claim for a process in which user of the article in a particular way or in a particular collocation may produce or help to produce a novel and useful result...
150 In Interlego A.G. v Toltoys Pty Ltd (1973) 130 CLR 461 at 480, Barwick CJ and Mason J observed that it is permissible to limit a claim by reference to result, so long as, in the case of an article, the limitation is “sufficient to characterize the construction of the article claimed” (quoting Mullard at page 16): see also GlaxoSmithKline Consumer Healthcare Investments (Ireland) (No 2) Ltd v Apotex Pty Ltd (2016) 119 IPR 1; [2016] FCA 608 at [700] (Beach J).
151 I turn then to consider claim 1.
152 Claim 1 commences with language indicative of a product claim. Integer 1.1 states, “An apparatus for use in assessing strength of at least one knee flexor muscle of a subject, the apparatus including” and this is followed by the other integers of claim 1. There is no dispute between the parties that the words “for use” in integer 1.1 means “suitable for use” in, or “capable of”, assessing strength of at least one knee flexor muscle of a subject, and I agree with that construction.
153 The remaining integers of claim 1 (which are repeated for convenience) are:
1.2 two securing members;
1.3 each securing member being configured to secure a respective lower leg of the subject in a position that, in use, is substantially fixed relative to a support when the subject lowers the subject’s upper body from a kneeling position to perform an eccentric contraction of the at least one knee flexor muscle of the subject; and
1.4 at least one sensor coupled to at least one of the securing members;
1.5 to sense a force applied to the at least one securing member by the subject’s knee flexor muscle acting in eccentric contraction while the subject lowers the subject’s upper body, the force being indicative of the strength of the at least one knee flexor muscle acting in eccentric contraction.
154 These integers identify physical features of the disclosed apparatus (such as two securing members) as well as functional limitations being that, when the apparatus is in use:
(1) each securing member is substantially fixed relative to a support when the subject lowers their upper body from a kneeling position to perform an eccentric contraction of at least one knee flexor muscle. Thus, each securing member of the apparatus will fall within the meaning of integer 1.3 if, when the subject lowers their body in the way described in that integer, it is substantially fixed relative to a support; and
(2) there is at least one sensor coupled to one of the securing members which senses a force applied to that securing member when the subject lowers their upper body in performance of the said eccentric contraction, the force being indicative of the strength of the at least one knee flexor muscle acting in eccentric contraction. Thus, the apparatus will fall within claim 1 if there is at least one sensor coupled to one of the securing members, which sensor will fall within the meaning of integer 1.5 if, when the subject lowers their body in the way described in that integer, it senses a force applied to that securing member, the force being indicative of the strength of the at least one knee flexor muscle acting in eccentric contraction.
155 The result is that by means of an apparatus as claimed, an assessment of the strength of at least one knee flexor muscle of a subject can be undertaken in a reliable and accurate way in order to provide clinically relevant information. An apparatus which does not achieve this result is not claimed.
156 I am satisfied that the functional limitations or limitations by result which are disclosed in claim 1 are sufficient to characterise the construction of the apparatus claimed such that “a worker in the art may know whether an article which he has made does or does not infringe the patent” (Mullard at page 10) or “conditions of their manufacture can be adjusted by the reader of the specification, to secure the specified result” (Axent at [275]).
157 Further, this is not a claim of the kind described in Foxtel at [37] (upon which KangaTech relied) in which the product described in the claim is actually required to perform an action.
158 For these reasons, I construe claim 1 as a product claim limited by result.
159 By accepting that claim 1 is a product claim limited by result, I do not agree that Vald “seeks to construe claim 1 to remove any of the integers conditioning the use of the apparatus” as submitted by KangaTech. That is because the functional limitations referred to above are integers conditioning the use of the apparatus and so have not been “removed”. For the same reasons, I do not accept KangaTech’s submission that the practical consequence of this construction is that claim 1 would capture “any apparatus that had [two] securing members fixed to a support, and at least one sensor coupled to a securing member, irrespective of how such an apparatus may be used”.
160 By its cross-claim, KangaTech alleges that each of the claims of the Patent are invalid for lack of sufficiency (also called lack of disclosure) and lack of support, as well as for lack of inventive step. This case was only pressed if it was found that claim 1 encompassed a situation where only one leg was secured by the securing member.
161 Although such a finding was not made, the allegations concerning validity will be addressed in any event and on the hypothesis that claim 1 does not require both legs to be secured in the securing members (which is contrary to my construction).
6.1 Lack of disclosure and lack of support
162 In Jusand Nominees Pty Ltd v Rattlejack Inventions Pty Ltd [2023] FCAFC 178, Perram J, with whom Nicholas and McElwaine JJ agreed, stated the following in relation to these grounds of invalidity at [154]–[155]:
Amongst the various grounds on which a patent may be found invalid are two which concern the relationship between the claims of the patent and its specification. This relationship is regulated by ss 40(2)(a) and (3) of the Act which provide:
(2) A complete specification must:
(a) disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art; and
…
(3) The claim or claims must be clear and succinct and supported by matter disclosed in the specification.
The requirement in s 40(2)(a) is often referred to as the sufficiency obligation whilst the requirement in s 40(3) is referred to as the support requirement. The sufficiency requirement requires that the patentee should sufficiently disclose in the specification how to perform the invention. The support requirement requires that the claims defining the patent should themselves be supported by what appears in the specification. In many cases these obligations may tend to be the same since they are describing the same relationship although viewed from the differing perspectives of the claims and the specification. As Burley J has observed in Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477; 155 IPR 1 (‘Merck Sharp’) at [543], they may often be viewed as two sides of the same coin. But they may nevertheless sometimes differ as Birss J (as his Lordship then was) explained in Illumina Cambridge Ltd v Latvia MGI Tech SIA [2021] EWHC 57 (Pat); RPC 12 (‘Illumina’) at [255].
163 KangaTech relies upon the same particulars for lack of disclosure and lack of support.
6.1.3 Consideration: particular (i)
164 The first particular of invalidity is as follows:
To the extent that the claims of the Patent extend beyond the use of an apparatus where the subject has both their legs secured (i.e., fixed relative to the support (platform) in order to perform an eccentric contraction of at least one hamstring (knee flexor) there is no support for such a claim.
165 While the use of the product is not ordinarily relevant to an inquiry into disclosure or support for a product claim, where that claim is for a product limited by result (as I have found), and the words “for use” appear in the claim, the disclosure of the configuration of the product such that it can be used to achieve that result is required.
166 Vald submits that the specification explains how a unilateral Nordic curl would be performed at [0085] of the specification, and that “Patent specifications need not set out every detail necessary for performance but can leave the skilled man to use his skill to perform the invention”, citing Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) (2020) 155 IPR 1; [2020] FCA 1477 at [524] (Burley J). It also disputes that undue experimentation or modification would be needed to allow the performance of a unilateral Nordic curl.
167 The experts agreed that a unilateral Nordic curl could be performed on the apparatus if one leg was left unsecured. However, the experts disagreed on whether the Patent provides sufficient information on how to perform a unilateral Nordic curl using the apparatus.
168 Dr Lovell’s opinion is that the apparatus is not suitable for the performance of a unilateral Nordic curl without modification. His opinion is that performing a unilateral Nordic curl on the apparatus as depicted in the Patent could not be performed in a controlled manner by most subjects, and as such, would not be properly described as them having performed a Nordic curl and would be a measure of limited utility in a clinical sense. Given that the claims require the assessment of strength of a knee flexor muscle in a reliable and accurate way to provide clinically relevant information, Dr Lovell’s expressed concerns that use of the disclosed apparatus to perform unilateral Nordic curls would not lead to an accurate measure of force or a clinically relevant assessment of strength provides a strong indication that there is not an enabling disclosure of all of the things falling within the scope of the claims.
169 Dr Lovell expressed the opinion in the JER that, for the apparatus to be suitable, the subject’s contralateral leg ought to be secured and that a support structure for the subject’s body weight ought to be added. The Patent does not refer to either of these features. Further, the Patent does not provide any detail on where the contralateral leg is to be positioned, whether secured or not, and Dr Lovell considers that the manner in which that leg was to be positioned would not be known by the skilled addressee as at the priority date.
170 Dr Pizzari refers to [0085] and [0173] of the specification as providing suitable information for a unilateral Nordic curl to be performed. It will be recalled that [0085] of the specification states as follows:
Furthermore, the assessment of hamstring strength may occur during a unilateral or bilateral contraction/s of the hamstring/s. For example, during a bilateral contraction, two sensors 130.1, 130.2 may be used to sense the force in each leg of the subject simultaneously or at different times, or alternatively a single sensor 130.1, 130.2 may be used to sense the force in either or both legs. During a unilateral contraction, the apparatus may include one sensor 130.1, 130.2 which is interchangeable between the lower legs of the subject, by repositioning the sensor 130.1, 130.2 and/or the securing members 121, 122 and/or the subject S relative to the support 110, such that the hamstring strength in both legs can be assessed sequentially. However, this feature is not essential.
(Emphasis added.)
171 However, the above description does not provide any information about the configuration of the sensor, securing members, or the subject. Rather, by [0085], the Patent itself contemplates that the apparatus requires some modification, even if only of the repositioning of its constituent parts, for a unilateral Nordic curl to be performed.
172 Further, [0173] of the specification (which refers to exercises performed during the Reliability and Validity Experiments) does not provide any further guidance on how the apparatus is to be configured for the performance of a unilateral Nordic curl.
173 The content of [0085] and [0173] stands in stark contrast to the level of detail contained in the lengthy specification (including multiple drawings) concerning the performance of a bilateral Nordic curl on the disclosed apparatus.
174 Further, I have found that the performance of a unilateral or one-legged Nordic curl for the purposes of obtaining a reliable force measurement, or the manner in which such an exercise would be done, was not common general knowledge as at the priority date.
175 Having regard to this finding and to the evidence of Dr Lovell (which I prefer to that of Dr Pizzari for the reasons explained above), the disclosure in the Patent does not enable the person skilled in the art to work the product in such a way as for it to be suitable for the performance of a unilateral Nordic curl without inventive skill or undue burden: see Merck at [525].
176 For these reasons, if Vald’s construction of claim 1 had been the correct one such that it encompassed only one leg being secured by a securing member, I would have found that particular (i) is made out, and that claim 1 and its dependent claims would be invalid for lack of disclosure.
177 In ToolGen Incorporated v Fisher (No 2) [2023] FCA 794 at [410], Nicholas J observed that “it is difficult to see how a claim to an invention for which there was no enabling disclosure could meet the support requirement”.
178 In this case, the inquiry for lack of support is the same as that set out above for lack of disclosure. This has the consequence that, if Vald’s construction of claim 1 had been the correct one such that it encompassed only one leg being secured by a securing member, I would have found that particular (i) is made out, and that claim 1 and its dependent claims would be invalid for lack of support.
6.1.4 Consideration: particular (ii)
179 The second particular of invalidity is as follows:
To the extent that the claims of the Patent extend beyond the use of an apparatus where (at least one of) the securing members is attached via the sensor(s) to the support (platform) there is no support for such a claim.
180 KangaTech’s submissions on this aspect of its case are as follows:
To the extent that the claims of the Patent extend beyond the use of an apparatus where (at least one of) the securing members is attached via the sensor(s) to the support there is no support… for such a claim.
Both experts agree that, in the context of the claims, the “support” means the base of the device where the subjects [sic] knees rest and that the intention of the “support” is to support the subject’s body weight during an exercise. This construction is consistent with numerous passages in the Patent.
The Patent does not describe a securing member attached to the support other than directly via the sensor (to which it is coupled), where that sensor is attached directly to the support. In particular, it does not describe a securing member indirectly mounted to the support by being mounted on a separate part of the apparatus.
(Footnotes omitted.)
181 However, this claimed ground of invalidity is rejected because the invention described in the specification does not require the securing members to be attached via the sensor(s) to the support.
182 In various examples of the apparatus depicted in the specification, the securing members 121 or 122 are not attached to the support 110 via the sensor 130, namely:
(1) in Figure 3H, the securing member 121 is coupled to the sensor 130 by a movable coupling 310 through an aperture 311 in the support 110: see, e.g., [0104]. As such, neither the securing member nor the sensor is attached directly to the support;
(2) in Figures 4A and 4B, the sensors 130 are attached to a movable coupling 310, which itself is coupled to the support 110: see, e.g., [0106];
(3) in Figures 4C and 4D, the securing members 121, 122 are movably mounted to the support 110 via movable portions 453, 454 using guiding members such as guide rails, pins and pin holes: see, e.g., [0110]–[0111].
183 Further, in the example for Figures 4A to 4H (commencing at [0105]), it is made clear that it is “not essential” for the securing members to be coupled to the support: see [0109] which states:
In this example, it will be appreciated that additionally, the one or more securing members 121, 122 may be coupled to the support 110. However, this feature is not essential.
184 Finally, the three broad forms of the invention do not require the securing members to be attached via the sensor(s) to the support.
185 As such, I do not agree that there is a lack of disclosure or lack of support as contended by KangaTech, with the consequence that the ground of invalidity as set out in particular (ii) is not established.
186 For these reasons, had Vald’s construction of claim 1 been the correct one such that claim 1 encompassed only one leg being secured by a securing member (which it is not), particular (i) would be made out with the consequence that claim 1 and its dependent claims are invalid for lack of disclosure and support.
187 However, irrespective of the construction of claim 1, the ground of invalidity as set out in particular (ii) fails.
188 Section 7(2) of the Patents Act provides that:
For the purposes of this Act, an invention is to be taken to involve an inventive step when compared with the prior art base unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed (whether in or out of the patent area) before the priority date of the relevant claim, whether that knowledge is considered separately or together with the information mentioned in subsection (3).
189 Section 7(3) of the Patents Act provides that:
The information for the purposes of subsection (2) is:
(a) any single piece of prior art information; or
(b) a combination of any 2 or more pieces of prior art information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have combined.
190 Section 7(2) of the Patents Act is a deeming provision and will defeat a claim of lack of inventive step unless the party challenging validity discharges its onus of establishing that the claim is obvious: AstraZeneca AB v Apotex Pty Ltd (2015) 257 CLR 356; [2015] HCA 30 at [18] (French CJ).
191 In Hanwha, Burley J observed at [414]–[415]:
The law concerning the requirement for an inventive step reflects a balance of policy considerations in patent law of encouraging and rewarding inventors without impeding advances and improvements by skilled, non-inventive persons: Lockwood No 2 at [48] (Gummow, Hayne, Callinan, Heydon and Crennan JJ). The cases over the years have made a number of statements as to what is required to answer the “jury question” of whether or not an invention is obvious. It is a question of fact. The question is not what is obvious to a court, but depends on analysis of the invention as claimed having regard to the state of the common general knowledge, any information relied upon for the purpose of s 7(3), and the approach taken to it by the person skilled in the art: Lockwood No 2 at [51].
As a basic premise, the question is always “is the step taken over the prior art an ‘obvious step’ or an ‘inventive step’?” This is often an issue borne out by the evidence of the experts: Lockwood No 2 [52]. Whilst the question remains one for the courts to determine, the courts do so by reference to the available evidence, including that of persons who might be representative of the skilled person in the art: AstraZeneca (HC) at [70] (Kiefel J, as her Honour then was).
192 Contrary to the submissions of KangaTech, it is not enough to ask whether the person skilled in the art would have arrived at the invention from the s 7(3) prior art by “taking merely routine steps” – that shorthand terminology does not reflect the nature of that inquiry. Rather, the “routine steps” inquiry is whether the steps from the prior art to the invention were “of a routine character” and would have been taken by the person skilled in the art “as a matter of course”, with the implicit expectation that such steps might well succeed: see for example, Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft (2014) 222 FCR 336; [2014] FCAFC 73 at [71] (Besanko, Middleton and Nicholas JJ); Aktiebolaget Hässle v Alphapharm Pty Limited (2002) 212 CLR 411; [2002] HCA 59 at [50]–[52] (Gleeson CJ, Gaudron, Gummow and Hayne JJ).
193 In Aktiebolaget Hässle at [53], it was observed that the routine steps approach outlined above has an affinity with the reformulation of the “Cripps question” by Graham J in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157. The High Court accepted the reformulated Cripps question as a test for obviousness (re-affirmed in AstraZeneca at [15]). Graham J’s reformulation involves asking whether the person skilled in the art would, at the relevant date and in all the circumstances, be directly led as a matter of course to try the claimed invention in the expectation that it might well produce a useful or better alternative. The expectation is a reasonable expectation of success: see Technological Resources Pty Ltd v Tettman (2019) 147 IPR 423; [2019] FCA 1889 at [226] (Jagot J), citing Ranbaxy Laboratories Ltd v AstraZeneca AB (2013) 101 IPR 11; [2013] FCA 368 at [209] (Middleton J).
194 The question does not require, as a criterion of obviousness, that the inventive step would be perceived by the person skilled in the art as “worthwhile to try” or “obvious to try”: AstraZeneca at [15]; see also Technological Resources at [226].
195 This Court has regularly adopted the reformulated Cripps question across varied areas of technology, including in the context of “apparatus for” claims: see, for example, Root Quality at [91]–[93] (container suitable for growing plants); Technological Resources at [226], [287]–[288] (apparatus for upgrading ore); JMVB Enterprises Pty Ltd v Camoflag Pty Ltd (2005) 67 IPR 68; [2005] FCA 1474 at [88], [127] (Crennan J) (collapsible campervans); Bitech Engineering v Garth Living Pty Ltd (2009) 84 IPR 78; [2009] FCA 1393 at [137] (Foster J) (apparatus for simulating flames); Davies v Lazer Safe Pty Ltd (2018) 132 IPR 202; [2018] FCA 702 at [361], [385], [402], [404] (McKerracher J) (safety system for use with machinery having moving parts); Nichia Corp v Arrow Electronics Australia Pty Ltd (2019) 175 IPR 187; [2019] FCAFC 2 at [67], [113] (Jagot J, with whom Besanko and Nicholas JJ agreed) (white light emitting device).
196 An invention will not be obvious “where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful” or “where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it”: Aktiebolaget Hässle at [76] quoting Judge Rich in In re O’Farrell (1988) 853 F 2d 894 at 903.
197 KangaTech relies on:
(1) articles described as Nadler 1 and Nadler 2 (together, the Nadler Articles) (being articles published by Scott Nadler and others in the Archives of Physical and Medical Rehabilitation, Volume 81 (August 2000) at page 1072 and in Volume 85 (April 2004) at page 598. The second Nadler paper is a continuation of the work described in the first paper); and
(2) United States Patent 6,149,550, described as the Shteingold Patent which was filed on 30 September 1999 and dated 21 November 2000,
considered in the context of the common general knowledge as at the priority date.
198 There was no dispute that Nadler 1, Nadler 2 and the Shteingold Patent were prior art which fell within s 7(3) of the Patents Act.
6.2.3 Common general knowledge
199 There was no dispute that the following matters were common general knowledge as at the priority date:
(1) HSIs are relatively common in athletes at virtually all levels of sport and represent the most prevalent injury in athletics and various team sports, such as soccer, rugby and AFL;
(2) sports medicine specialists, physiotherapists and sport scientists have focused on ways in which HSIs can be prevented and treated for many years. One specific exercise known to minimise the risk of HSI is the Nordic curl or NHE;
(3) sports medicine specialists, physiotherapists and sport scientists have, for many years, performed muscle strength testing. This is done to evaluate muscle strength, identify imbalances or weakness that may be potential risk factors for muscle injury, evaluate the efficacy of a training intervention, and for the purpose of prescribing exercises for strength development and as part of injury recovery;
(4) the commonly used methods for measuring muscle strength were the use of isokinetic dynamometers, hand-held devices (dynamometers) and manual testing;
(5) isokinetic dynamometers are electromechanical accommodating resistance equipment which automatically adjusts to provide a counterforce to variations in force generated by the muscle group being assessed through its range in motion. They are expensive, require experienced operators, have limited portability and require significant time to assess each leg of a subject independently;
(6) hand-held devices (dynamometers) are muscle force measuring devices that are small enough to be held in the assessor’s hand. They were known to have limitations, including as to the degree of expertise required from the tester to ensure results are accurate and reliable. For example, the tester needs to ensure that the resistance force (against which the person’s muscle force was to be measured) was the same on each occasion.
200 Nadler 1 is entitled: “Portable Dynamometer Anchoring Station for Measuring Strength of the Hip Extensors and Abductors”. Nadler 2 is entitled: “The Intra- and Interrater Reliability of Hip Muscle Strength Assessments Using a Handheld Versus a Portable Dynamometer Anchoring Station.”
201 Both articles discuss the testing of subjects in order to assess the reliability of a dynamometer anchoring station or DAS. The DAS is comprised of a commercial dynamometer attached to a specially designed portable and adjustable mechanical platform, which is then affixed to an examination table. The dynamometer contains a force plate on a pressure transducer, which interfaces with a control pad.
202 The testing which was performed using the DAS and discussed in Nadler 1 was of the hip abductors (with the subject lying on their side and pushing their top leg against the force plate) and the hip extensor muscles (with the subject lying on their stomach and raising one leg to push against the force plate). The conclusion reached in Nadler 1 was that:
The dynamometer anchoring station has been specially designed to allow highly reliable measures of hip girdle muscle strength. The platform, which stabilizes the dynamometer, allows measures to be collected without support from the examiner and maintains results unaffected by the examiner’s strength and ability. Strength of the proximal hip musculature can now be reliably and rapidly obtained for use in large-scale screenings. This may be used to accurately assess the role of hip strength and/or side-to-side muscle balance on injury occurrence or postinjury treatment outcome.
203 The testing which was performed using the DAS and discussed in Nadler 2 was of strength measurements of hip flexors, abductors and extensors which were collected bilaterally. The same two types of tests were performed as had been reported in Nadler 1 to test hip extensors and hip abductors, but a third test was performed which was of the hip flexors. To test hip flexors, the subject was seated at the end of the examination table with their hips and knees at a 90° angle, with their lower legs hanging off the table. The force plate was lowered to just above the subject’s distal anterior femur, and the subject pressed their leg against it with as much force as necessary to maintain the dynamometer in a static position. The conclusions reached in Nadler 2 were as follows:
Fair to good interrater reliability was shown for the DAS in the measurement of hip flexion and abduction, whereas measurement of hip extension may be less reliable. Low interrater ICC values were most likely because of testing of multiple muscles on numerous occasions with subject fatigue and motivation to exert a maximal contraction as a potential factor. The DAS was more reliable than the HHD in the assessment of hip flexion and abduction, whereas the HHD was more reliable for hip extension. This may reflect the limited visualization of the transducer while the subject was prone in the DAS testing. Overall, the DAS was easy to secure to a table, easy to adjust, and minimized tester influence during assessments. The HHD may be difficult to stabilize in a tester with less physical strength, especially when testing the powerful hip girdle musculature. Future testing may include assessment of individual muscle groups, so that the chance of mental or physical fatigue is minimized.
204 After summarising the content of the articles, KangaTech’s closing submissions on inventive step were as follows:
While the DAS was developed for measuring the force exerted by hip extensors and abductors, the DAS could be used – either as it is or with minor modifications – to measure the strength of a knee flexor during performance of an NHE.
To the extent that any modifications to the DAS were required to enable the performance of an NHE, it would be a simple matter to use material that were structurally suited for the purpose and ensuring that: (a) the clamps supporting the DAS were securely fixed to the examination table (or any other flat surface) which is forming the ‘support’; and (b) the cross-bar to which the dynamometer is fixed (which on the DAS is wooden) was sturdy enough to resist the upward force of the subjects ankles.
Furthermore, adding another dynamometer to the DAS so that both legs could be tested simultaneously would be a routine matter as it would only involve duplicating the sensor that was already present on the force plate of the DAS apparatus disclosed in Nadler 1.
205 The thrust of KangaTech’s submissions is that modifications could be made to the DAS to enable the performance of an NHE, which KangaTech describes as “minor”, “a simple matter” and “a routine matter” without referencing these descriptions to any expert evidence.
206 However, as already observed, the question is not whether the person skilled in the art could have taken steps to “modify” the prior art so that it has features of the claimed invention. Rather, the question is whether the person skilled in the art would, as at the priority date, have been directly led from the Nadler Articles to the claimed invention with a reasonable expectation of success or, otherwise, whether such steps as were necessary to go from the Nadler Articles to the claimed invention were “of a routine character” and would have been taken by the person skill in the art “as a matter of course” with the implicit expectation that such steps would succeed.
207 KangaTech’s closing written submissions as to modifications appear to have been based on the evidence of Dr Lovell. Having first been given the Patent and commenting on it in detail, he was then given the Nadler Articles (and the Shteingold Patent).
208 Dr Lovell then opined that the devices disclosed in the prior art could be used to enable a subject to perform a Nordic curl, including with particular modifications to those devices. When he expressed that opinion, he was already familiar with the patented apparatus, its features and the solution which it provides. In that context, he was “thinking about… what steps [he] would make” so that an eccentric Nordic curl could be done on the DAS.
209 Although Dr Lovell’s evidence may be taken to establish that a person skilled in the art could have arrived at the claimed invention by modifying prior art, namely the DAS disclosed in the Nadler articles, Dr Lovell’s evidence does not establish that he would have made these modifications as a matter of course.
210 In any event, the weight to be given to this evidence is diminished by Dr Lovell having been given the Patent, and thus being aware of the solution in it, before commenting on the prior art.
211 In Minnesota Mining & Manufacturing Co v Tyco Electronics Pty Ltd (2002) 56 IPR 248; [2002] FCAFC 315 at [45]–[46] (Heerey, Emmett and Dowsett JJ), the Full Court observed that where, as here, an expert witness is first provided with a copy of the patent, this is:
…hardly calculated to result in objective evidence as to what the hypothetical uninventive but skilled worker would have done. To give the patent to a prospective witness is tantamount to leading the witness… where evidence is obtained in circumstances such as just described, the evidence is not likely to be helpful at all.
212 In PAC Mining Pty Ltd v Esco Corporation (2009) 80 IPR 1; [2009] FCAFC 18 at [80] (Sundberg, Jessup and Middleton JJ), the Full Court found that the primary judge was correct to hold that an expert witness’ evidence about what would have been done was “compromised” because he was “exposed” to the solution in the patents before he explained how a piece of prior art could be “adjusted” to fall within the claims of those patents.
213 In addition, KangaTech’s submissions did not grapple with the expert evidence especially where that evidence either did not support or contradicted the submissions.
214 In the JER, the experts agreed that, as at the priority date, the DAS presented in the Nadler articles would have been understood to be an externally fixed dynamometer capable of measuring isometric hip abduction, hip extension and (in the case of Nadler 2 only) hip flexion strength. They agreed that there is no reference in the Nadler articles to use of the DAS for performing a NHE.
215 Further, both experts agreed that performing a Nordic curl on the DAS “may be unsafe”. Dr Lovell considered that the DAS would not have been stable enough, especially for heavier and stronger clients within the potential client base. The experts agreed that the DAS would require modifications to make it sufficiently stable to accept the weight of a Nordic curl, including that it should be connected to support closer to the ground and, in Dr Lovell’s view, the device would need to be constructed from a stronger substance than wood in order to be used for heavier/stronger clients. Contrary to KangaTech’s submissions, the DAS therefore could not be used “as it is” to measure the strength of a knee flexor during performance of a Nordic curl.
216 The differences between the DAS and the claims are substantial. As set out in the JER, the experts agree that the Nadler Articles do not, or otherwise cannot be said to, disclose independent claim features: 1.1, 1.2, 1.3, 1.5, 18.2 and 18.4 and dependent claims features: 2.2, 3.2, 3.3, 4.2, 5.2, 6.2, 8.2, 11.2, 12.1, 12.2, 13.1, 13.2, 15.2, 16.2, 16.3, 16.4 and 20.2. Dr Pizzari’s unchallenged evidence was that dependent claim features 7.2, 9.3 and 19.2 are also not disclosed. With that in mind, KangaTech does not explain how it can be said that only minor modifications would be required to the DAS.
217 Further, the evidence does not support KangaTech’s assertions that the so-called “modifications” from the DAS disclosed in the Nadler Articles to the claimed invention were “routine”. Even if they had wanted to modify the DAS to have the features of claim 1 of the Patent, “plenty of… practitioners and clinicians” would have looked at the DAS at the priority date and been unable to do so, according to Dr Lovell. For example:
(1) the DAS “would essentially have needed to be rebuilt”: for instance, an additional force plate transducer and dynamometer would be required as well as an additional arcuate member, but (at least in Dr Pizzari’s view) the DAS does not have enough space to fit this;
(2) it would take significant modification, and be difficult, to extend the crossbar so as to fit two securing members, given the clamps’ positioning;
(3) the addition of securing members would have required force plates to be identified that were compatible with the CSD-500 force transducer. However, the force plate pictured in the Nadler articles appears to be the standard force plate provided with the dynamometer, rather than one which features greater curvature to improve the ability to secure the subject’s leg(s). It is unknown if alternative compatible securing members were available;
(4) as the experts agreed, the DAS does not have a support. According to Dr Pizzari, its width limits the nature of any support to be added. Further, attaching a support would make it less portable, in circumstances where (according to Dr Lovell) portability was a significant feature of the DAS.
218 Importantly, the expert evidence established that the person skilled in the art would not have been directly led to modify the DAS to make it suitable for the performance of an NHE. For example:
(1) Dr Lovell agreed that the steps he proposed to modify the DAS would not have been taken as a matter of course;
(2) Dr Pizzari explained that most people in sports medicine at the priority date would not have looked at the DAS and thought it would be appropriate to utilise for a Nordic curl.
219 The Abstract of the Shteingold Patent describes the apparatus as follows:
A muscle strength testing and measuring apparatus contains a bar-like strength testing mechanism slidably placed over a pair of upright posts for adjustment of vertical position and allowing a variety of muscle groups to be tested by the user without any specialized knowledge. The apparatus can be used for physical training before and after exercise as well as for rehabilitation purposes. The position adjustment mechanism includes a jamming cylinder controlled by a link plate, which in turn can be activated by simple lifting or lowering the bar-like mechanism. Piezo-electric tensile sensors are placed in the middle portion of the mechanism to indicate the muscle force which signal is then transmitted to a display unit. Additional pull force strength testing units are placed over the same posts allowing also for adjustment of height position. A great number of configurations are described that can be achieved by easily switching the apparatus from one position to the next.
220 Below the Abstract, and also depicted as Figure 1, is the following drawing:
221 The Summary of the Invention (columns 2 and 3) states as follows:
Accordingly, it is an object of the present invention to overcome these and other drawbacks of the prior art by providing a novel muscle strength testing and displaying apparatus designed to indicate the strength of a wide variety if not most major groups of muscles of a human being with easy and fast changes of apparatus configurations.
It is another object of the present invention to provide a muscle strength testing apparatus capable of easy adaptation to users of various size and physical abilities. It is yet a further object of the present invention to provide a muscle strength testing apparatus for use by a person without any specialized skills.
According to the invention, there is provided a muscle testing apparatus consisting of a horizontal bar-like muscle strength testing mechanism for measuring of applied force. This mechanism is capable of sliding over a couple of vertical posts each containing a position adjustment mechanism between the post and that muscle testing mechanism. Each position adjustment mechanism contains a sliding cylinder designed to jam against the post when tilted by a link plate in turn activated by the movement of the muscle testing mechanism.
The middle portion of the muscle testing mechanism contains a number of tensile sensors such as a piezo-electric sensor. When the user applies force through a clearly marked grip area of the mechanism, the signal from the tensile sensors is transmitted through a computational block to a display unit.
Additionally, pull force testing units are provided on one or preferably both vertical posts that are designed to allow adjustment of their position as well along the posts. Each unit contains a spring-loaded housing and a force displaying gauge activated by pulling on a flexible link such as a cable or a rope. Depressing of a spring via a lever releases the housing and allows repositioning along the post.
For a better understanding of the invention, its operating advantages and the specific objects attained by its uses, reference should be made to the accompanying drawings and descriptive matter in which there is illustrated a preferred embodiment of the present invention.
222 In the above drawing, the “middle portion” is part of item 2 which is also depicted in Figure 2 (not reproduced here). The “grip zones” are labelled 12, and they “indicate to the user the correct position of applying force to the mechanism (1) to insure [sic] accurate measurements”.
223 In the JER, the experts agreed that, at the priority date, the apparatus in the Shteingold Patent “would have been understood to be an externally fixed force measurement device allowing the objective measurement of force during a range of different exercises”.
224 The differences between this apparatus and the claims are substantial. The experts agreed that the apparatus disclosed in the Shteingold Patent does not contain securing members or a support and does not depict that eccentric strength of at least one knee flexor can be measured in an NHE. In the JER, the experts also agreed that the Shteingold Patent does not, or otherwise cannot be said to, disclose independent claim features: 1.2, 1.3, 1.4, 1.5, 18.2, 18.3, 18.4, 18.5 and dependent claim features: 2.2, 3.3, 4.2, 5.2, 6.2, 7.2, 8.2, 15.2, 16.2, 16.3, 16.4.
225 After summarising the apparatus disclosed in the Shteingold Patent, KangaTech submitted as follows:
The primary object and advantage of the apparatus disclosed in the Shteingold Patent is “to indicate the strength of a wide variety if not most major groups of muscles of a human being with easy and fast changes of apparatus configurations.” (see column 2 lines 45-54).
The Shteingold Patent does not explicitly refer to the NHE or depict it being performed. However, consistent with the primary objective of the invention described, the apparatus could be readily configured, and would have the requisite strength, to allow a subject to perform a NHE and to measure the strength of the hamstring muscles while performing an eccentric contraction of the knee flexors.
In particular, the user could vertically adjust the horizontal cross-bar so that it was relatively close to the ground but still high enough to enable the user to place her/his ankles against the clearly marked grip zones - depicted as a cross-hatched area (item 12) in figure 1 - such that the lower legs were ‘secured’. As the user then lowered their upper body slowly to the ground, engaging the hamstring muscles to slow their descent, the user’s ankles would press against the grip zones such that the sensors in the grip zones would measure the force produced by lower legs during the NHE.
Apart from the adjustment of the horizontal bar referred to above, the only other modification necessary to measure the hamstring forces generated during an NHE using the apparatus would involve adding an extra sensor and display unit.
(Emphasis original.)
226 As was the case for the Nadler articles, the question is not whether the person skilled in the art could have taken steps to “modify” the prior art so that it has features of the claimed invention. Rather, the question is whether the person skilled in the art would, as at the priority date, have been directly led from the Shteingold Patent to the claimed invention with a reasonable expectation of success or, otherwise, whether such steps as were necessary to go from the Shteingold Patent to the claimed invention were “of routine character” and would have been taken by the person skilled in the art “as a matter of course” with the implicit expectation that such steps would succeed.
227 As to this, the experts agreed during the concurrent evidence session that a skilled person at the priority date would not look at the Shteingold Patent and be minded to make modifications to it to make an apparatus having the features of claim 1 of the Patent. The experts also agreed that modifying the Shteingold apparatus to have the features of claim 1 of the Patent would not be simple.
228 Further, the Shteingold Patent does not give any guidance as to the use of the apparatus disclosed for the purpose of performing a Nordic curl. Given the (lack of) stability of the entire frame, Dr Pizzari considered that it would not be feasible to do Nordic curls on the apparatus.
229 The experts also agreed in the JER that other modifications would be required to enable the measurement of the force generated by a subject performing an NHE on that apparatus as at the priority date which are not referred to in KangaTech’s submissions. In particular, there would need to be an anchor to support the subject’s lower legs and separate force transducers (to measure force in both legs simultaneously).
230 Finally, applying the same reasoning as set out above in relation to the Nadler Articles, little weight can be given to Dr Lovell’s affidavit evidence about the Shteingold Patent, which evidence formed the basis of KangaTech’s submissions about the required modifications.
231 For these reasons, irrespective of the construction of claim 1, KangaTech failed to rebut the presumption provided by s 7(2) of the Patents Act with the consequence that the invention in the Patent is to be taken to involve an inventive step.
232 KangaTech admits that it has made, sold and supplied, and offered to make, sell and supply (among other acts) in Australia the KangaTech Product and the KT360. In addition to selling it to them, KangaTech has also leased the KT360 to customers.
233 The KangaTech Product comprised a single portable frame which consisted of a base plate, with a mounting socket on each side; two vertical frame members mounted and secured to the base plate; a horizontal crossbar mounted on the vertical frame members which was parallel to and above the base plate; and two JTech dynamometers affixed to the horizontal crossbar or to the vertical members (depending on the particular exercise) to measure and transmit the force data to the software running on a tablet or laptop. The horizontal crossbar, and the position of the dynamometers on the horizontal crossbar and/or upright bar or frame members, were adjustable. As a result, the KangaTech Product had flexibility to test and train over 25 different muscle groups across the foot, ankle, knee, thigh, hip, lumbo-pelvic trunk, shoulder and neck regions. However, the dynamometers had periodic connectivity and battery issues and required time-consuming repositioning on the frame using screw threads to allow all tests to be performed, and the frame and base (while stable) were aesthetically not up to standard.
234 The KT360 is a more sophisticated and complex system involving both hardware and software components. In particular, for the KT360 to work, the user must first select a protocol from the tablet. The selection of this protocol then results in the sensors, appropriate for that exercise, to light up. It also activates those sensors, so that those sensors can measure and record force data.
235 The KT360 hardware is comprised of three main components being: a circular base pad; two vertical supports which are mounted into sockets on either side of the base pad; and a rotatable sensor unit located on a horizontal member mounted on the vertical supports, which is height adjustable and contains seven sensors. The horizontal member can slide up and down on the vertical supports and be readily clamped in position. The seven sensors are mounted at different locations within the sensor unit to reflect the different muscle groups being measured. Those sensors detect a force applied to them by the user and transmit that data via Bluetooth to a tablet or laptop.
236 An image of the KT360 is below:
237 Unlike the KangaTech Product, the design of the KT360 allowed the unit to be rotated in its entirety for different exercise setups without having to move individual force sensors. The KT360 enables an athlete to perform over 35 isometric and eccentric testing and training protocols across the whole body.
238 The KT360 frame has been designed with sufficient stiffness to ensure all forces generated during protocols are captured and not dampened or lost during the testing process. The KT360 hardware utilises grid markings on the base and poles and a gyroscope in the central sensor housing to ensure subjects are in the same posture, joints at the same angles, muscles at the same length and the sensors appropriately positioned at right angles to the test lever arm during all testing. These factors contribute to its ability to provide repeatable and accurate data and results.
239 The KT360 software comprises onboard firmware, contained within the main board located within the sensor unit. The main board controls the seven sensors and communicates via encrypted Bluetooth with the user’s tablet or laptop using a custom communication protocol. However, the user of the KT360 also requires software on the tablet or laptop which provides a User Interface and facilitates communication with the KT360. The firmware (contained in the main board) sends power to (and thus ‘activates’) the sensors which are to be used for a particular muscle measurement required for the session which the user wishes to conduct on the KT360. It also then receives the force measurement data from the activated sensors and transmits that data to the user’s tablet or laptop which will display the force and submit it to KangaTech’s cloud-based software.
240 The tablet enables the user to create and perform various sessions or exercise measurements and is the link between the firmware and the KangaTech software on the server.
241 The software allows monitoring and comparison of an athlete’s data over time, generation of reports and the export of data to a management system.
242 The exercise protocols are set out in the KangaTech User Guide to which all KT360 customers have access via a hyperlink accessible at: http://help.kanga-tech.com/. When a particular exercise protocol is selected by a user, the KT360 designates the particular sensors on the KT360 to be used (out of the seven available sensors) and activates only these sensors. These sensors light up to guide the user. It also provides details of the sensor housing position and angle and general set up to be adopted. Selection of a particular protocol also ensures that all data is stored under the correct test/exercise database enabling reference to previous tests/exercises conducted for that athlete and other athletes.
243 The main board will only activate sensors if it receives the appropriate message over the communication protocol, and if the device has first been unlocked using an encrypted session key. The session key is also used to decrypt the communicated messages between the tablet and the KT360. The session key is generated using the KangaTech master key and a unique session identifier which is generated by the firmware and changes daily. The KangaTech master key is stored only on KangaTech’s servers in the cloud and is not available to the tablet software. A session key is valid for a maximum of 24 hours and an authenticated connection to the server is required to obtain a new session key. KangaTech can ensure that only authorised users can communicate with the KT360, and can revoke access for specific user accounts on its servers, ensuring that new session keys are unable to be obtained.
244 The user of the KT360 has no control over the firmware installed on the KT360 device, other than via the user interface of the software tablet. The main board also includes a security measure which ensures only firmware that has been cryptographically signed by KangaTech will run on the board. A KT360 user also has no control over KangaTech’s server-based software which is controlled by KangaTech.
245 In December 2019, KangaTech made software modifications to the KT360. The version of the KT360 after this first set of modifications is described as the Post-First SM KT360.
246 In general terms, the modifications made in 2019 involved removing the NHE from all available “protocols” and modifying the software to disable the relevant sensors if an NHE was attempted on the KT360. The software modifications ensured that the two sensors used in detecting muscle force during an NHE – being sensors 2 and 6 as push (facing down) or pull (facing up) sensors – were unable to measure any force if anything greater than a negligible load/force was applied to them.
247 The software modifications also ensured that for any session using either or both sensors 2 and 6, a check is performed every 200 milliseconds to detect whether an NHE is being performed. If such forces are detected – that is on both sensors – the software immediately sends a message to the main board to disable all sensors in the sensor unit. At the same time, a message is displayed on the tablet or laptop in use. A message is also submitted to KangaTech’s servers to record the event.
248 The functionality which detects an NHE can give rise to false positives, such as instances where the user is not attempting an NHE but has inadvertently applied forces on sensors 2 and 6 simultaneously, triggering the deactivation.
249 The modified software code was released on 16 December 2019 via the internet and activated remotely from 31 December 2019. The KT360s sold, leased and supplied, etc, before 31 December 2019 are described as Pre-SM KT360.
250 The software modifications are not reversible or changeable by any user of a KT360 device. Any such change to the KT360 can only be done via a modification to the KangaTech software by KangaTech.
251 The requirement for the encryption key to enable communication with the firmware also prevents any KT360 user or any external third-party from communicating with the firmware using their own software to circumvent the removal of the NHE feature.
252 On 25 July 2022, further modifications were made to the KT360 software to prevent any force measurements when a Two Sensor Bilateral Nordic (which is defined below) is performed. The version of the KT360 after such modifications is described as the Post-Second SM KT360.
253 KangaTech has offered undertakings to the Court, which include an undertaking to not reverse, alter or otherwise change the modifications to the KT360 as described in identified affidavit evidence of Mr Scerri and Dr Saunders.
254 The references below to the Post-SM KT360 relate to that device post both tranches of software modifications.
255 Vald alleges that, by its conduct in relation to KangaTech Product and the KT360 (in all iterations), KangaTech has infringed various claims of the Patent.
256 These allegations are summarised in Vald’s closing submissions as follows.
257 First, Vald alleges that KangaTech’s exploitation of the KangaTech Product infringed claims 1–4, 6–14, 16 and 18–20.
258 Second, Vald alleges that KangaTech’s exploitation of the Pre-SM KT360 infringed claims 1–4, 6–14 and 16–20.
259 Third, Vald alleges that the Post-SM KT360 infringes the claims in three ways: by KangaTech exploiting various of the claims, under s 117 of the Patents Act and by authorising the customer’s infringement of the claims. Vald’s position is that the:
(1) Post-First SM KT360 infringed claims 1–2, 4, 6, 9–14 and 16–20;
(2) Post-Second SM KT360 infringes claims 1–2, 4, 6, 9–14, 16 and 17.
260 Each of these allegations will now be addressed.
261 KangaTech accepts that if any of claims 1–3, 6–14 and 18–20 are found to be valid (which they have been), then KangaTech’s exploitation of the KangaTech Product infringed such claims.
262 Dr Pizzari’s unchallenged evidence was that the KangaTech Product possesses all of the integers of claims 1–4, 6–14 and 16, or as used falls within the method in claims 18–20 of the Patent. KangaTech did not file any evidence answering this evidence and nor did it challenge this evidence at trial. Further, KangaTech did not make any submissions against a finding of infringement of claims 4 and 16 in relation to the KangaTech Product.
263 For these reasons, I find that, by its conduct in respect of the KangaTech Product, KangaTech has infringed claims 1–4, 6–14, 16 and 18–20.
264 With the Pre-SM KT360, a subject performing a bilateral Nordic curl would have his or her legs supported by placing them in the c-shaped securing members. These securing members were coupled with sensors 2 and 6, as depicted below:
265 The means by which an NHE was performed on the Pre-SM KT360 was described by Dr Saunders in his second affidavit by reference to sensors 2 and 6 as follows:
…The designated sensors are two out of seven in the sensor unit. These sensors were placed at this width (27.5cm) specifically to accommodate the average width of the human pelvis (distance between the hip joints) in the elite sporting populations we were dealing with. This spacing meant that a number or testing protocols for the lower limb would be made more accurate and reliable and decrease testing time by minimising the need to adjust, move or manufacture athlete/patient positions between tests. In the case of the NHE, this width provides a stable base on which to perform the NHE and minimises inadvertent/inappropriate adduction, abduction, medial or lateral rotation of the hip that would likely bias the recruitment of the medial or lateral knee flexor muscle groups.
Before modification, an NHE could be performed by the subject, kneeling on a marked knee pad facing away from the KT360 sensor unit and placing his or her lower legs/ankles against the two arcuate components secured in sensors 2 and 6. The subject would commence the exercise with his or her torso held vertically and, as the subject leant his or her torso forward, lowering it as slowly as possible, the descent of their torso would be controlled primarily by an eccentric contraction of the knee flexors with their lower legs/ankles pressing firmly against the arcuate components. The force of that pressure on the arcuate components would be measured by the designated sensors into which they were screwed.
My description above, describes a subject using the KT360 with the sensor unit slightly raised (on its vertical uprights) and rotated so that the relevant sensors face broadly downwards. Accordingly, the subject’s lower legs/ankles would be placed under the sensor unit, with each ankle resting against each of the arcuate components attached to sensors 2 and 6. Importantly, the housing rotation is fine-tuned in a manner that ensures the sensors remain at right angles to the lower leg or shin to ensure accurate measurement.
…
I note that the designated sensors into which the arcuate components were screwed were “designated” as they were mounted (within the sensor unit) at the correct distance apart laterally to ensure that the subject would, when placing his or her ankles against the arcuate components, have his or her knees roughly hip or pelvic width apart (~27cm) as described above. This is the correct width apart for the lower legs to ensure that the NHE is performed correctly i.e., without inappropriate positioning of the thigh or shin that may lead to differential recruitment of knee flexors and bias the test in a manner that skewed results and or made any comparisons between tests and/or between individuals invalid.
(Emphasis original.)
266 This evidence was not the subject of any challenge, nor was any submission made that it ought not be accepted. In these circumstances and having regard to the qualifications of Dr Saunders, I accept this evidence.
267 The experts agreed, or there was otherwise no dispute between them, that the Pre-SM KT360 possesses all of the integers of claims 1–3 and 6–14 and, when used in the manner described above, falls within the method in claims 18–20 of the Patent.
268 As to claim 17, this relevantly provides, “The apparatus according to any one of the preceding claims, wherein the sensor includes any one of a load cell… [among other options]… the sensor being configured to sense any one of compression and tension”. KangaTech’s evidence is that the KT360’s sensors are “load cell sensors”. Dr Pizzari’s unchallenged evidence is that an eccentric knee flexor contraction involves “compression”. It follows that the KT360 (in all of its iterations) possesses a sensor within the meaning of claim 17.
269 The only dispute between the experts concerning whether the KT360 possessed the integers of claims 4 and 16 turned on the proper construction of those claims. During closing submissions, KangaTech did not resist the construction of those claims as posited by Vald.
270 Claim 4 provides: “The apparatus according to any one of the preceding claims, wherein the securing members are movably mounted to the support.” The issue of construction is whether claim 4 requires that the securing members to be directly mounted to the support (Dr Lovell), or whether they can also be indirectly mounted to the support (Dr Pizzari).
271 At [0110]–[0111] of the specification, an embodiment of the invention is described which provides that “movable portions” may be “movably mounted to the support” using first and second guiding members, such as guide rails, pins and pin holes. This is exemplified in Figures 4C and 4D, which show that the movable portions (453 and 454) are movably mounted between the securing members (121, 122) and the support (110). This underscores that the securing members need not be directly fixed to the support. Dr Lovell agreed during the trial that these passages discussed “an indirect mounting on the support”.
272 For these reasons, claim 4 encompasses an apparatus where the securing members are indirectly, as well as directly, movably mounted to the support. The KT360 is such an apparatus. As explained by Dr Pizzari in the JER, the securing members are connected to grey casing and are indirectly attached, and therefore mounted, to the support. Further, the movement of the grey casing necessarily involves the movement of the securing members.
273 Claim 16 provides: “The apparatus according to any one of the preceding claims, wherein the support is elongated and wherein the securing members are provided at a first end of the support and a second end of the support is configured to support a weight of the subject.”
274 Relevantly:
(1) the second end of the support may be configured to support the “weight of the subject” at the end of the exercise. There is nothing in claim 16 which requires it to be configured to support the “weight of the subject” only during the exercise; and
(2) the support can be any suitable shape and can be formed by multiple members (whether or not interconnected): see [0091], [0093] of the specification.
275 Turning to the KT360, the dispute appears to be whether the “additional padding (rectangular shape with one arcuate end)” supports the weight of the subject within the meaning of claim 16. The padding is elongated within the meaning of claim 16 because it is longer than it is wide.
276 Dr Pizzari’s opinion is that the padding supports the weight of the subject “as they conclude the exercise and fall to the ground”.
277 Dr Lovell’s opinion is that the “support” in the KT360 is limited to the “circular platform”, apparently because the padding was not “contributing to the resistance and the stability of the exercise”. However, as already observed, claim 16 has no such requirement.
278 It follows that the KT360 (in all of its forms) has a support within the meaning of claim 16.
279 No submissions were made by KangaTech against a finding of infringement being made in relation to the Pre-SM KT360.
280 Instead, by its closing submissions, KangaTech conceded that, before the modifications were made to the KT360 “[An] NHE could be performed by the subject kneeling on a marked knee pad and placing her lower legs/ankles against the two arcuate components secured in sensors 2 and 6”. KangaTech also identified that the fundamental dispute between the parties in connection with infringement related to the KT360 after the modifications.
281 For these reasons, I find that, by its conduct in respect of the Pre-SM KT360, KangaTech has infringed claims 1–4, 6–14 and 16–20.
7.5 Performance of Other Nordics
282 In the Post-SM KT360, when both sensors 2 and 6 detect forces which are consistent with a bilateral Nordic curl being performed, the software immediately sends a message to the main board to deactivate the sensors and the forces are not measured.
283 However, Vald’s allegations of infringement in connection with the Post-First SM KT360 is premised on obtaining factual findings that users are able to perform and obtain force measurements using the sensors within the meaning of claims 1 and 18 for the following forms of Nordic curl (described by it as the Other Nordics):
(1) a bilateral Nordic curl in which the subject’s leg to be measured is secured in one c-shaped securing member and the subject’s other leg is constrained by the subject hooking it elsewhere (such as beneath the casing) (Single Sensor Bilateral Nordic);
(2) a unilateral Nordic curl, where the subject’s leg to be measured is secured in one c-shaped securing member and the other leg is unsupported (One Leg Nordic);
(3) a bilateral Nordic curl in which the positioning of one or both of the c-shaped securing members is adjusted from sensor 2 and/or sensor 6 to the middle sensor located between sensors 2 and 6, following which the subject’s legs are secured by respective securing members (Two Sensor Bilateral Nordic).
284 As already observed, on 25 July 2022, further modifications to the KT360 software were implemented. These prevent any force measurements when a Two Sensor Bilateral Nordic is performed. Thus, Vald’s allegations of infringement in connection with the Post-Second SM KT360 are only premised on obtaining factual findings that users are able to perform and obtain force measurements using the sensors within the meaning of claim 1 for the Single Sensor Bilateral Nordic and the One Leg Nordic.
285 Based on my construction of claim 1, even if the evidence established that users of the Post-SM KT360 were, or are, able to perform and obtain force measurements using the sensors within the meaning of claim 1 for the Single Sensor Bilateral Nordic and the One Leg Nordic, I would not make the factual findings sought by Vald because both legs are not secured by the securing members during these exercises.
286 This has the consequence, and I find, that:
(1) there has been no infringement by KangaTech of claims 1–2, 4, 6, 9–14, 16 and 17 in relation to the Post-First SM KT360 insofar as that case concerns the Single Sensor Bilateral Nordic and One Leg Nordic;
(2) there has been no infringement by KangaTech of claims 1–2, 4, 6, 9–14, 16 and 17 in relation to the Post-Second SM KT360. It follows that Vald’s infringement claim in relation to the Post-Second SM KT360 fails.
287 In any event, there are additional reasons that Vald’s infringement case fails in relation to the Post-SM KT360, which will now be addressed.
7.5.2 The demonstrations of the Other Nordics on Post-SM KT360
288 No evidence was adduced by Vald to show that the Post-SM KT360 was being used by any customers to perform the Other Nordics. Instead, Vald’s case on infringement rested upon acceptance of the expert evidence of Dr Pizzari, who (according to her second affidavit) performed an inspection of the Post-SM KT360 after being provided with “brief instructions” by Dr Saunders as to its operation. Dr Pizzari then instructed a “test subject” (as she described him in her second affidavit) to perform each of the Other Nordics on that device, and these demonstrations were filmed by Vald’s solicitors.
289 The evidence about this inspection and the exercises performed by the test subject was addressed in six paragraphs of Dr Pizzari’s second affidavit, and the short videos taken of the three exercises performed by the test subject (which make up the Other Nordics) were an exhibit to that affidavit.
290 During the concurrent session, other evidence emerged concerning the circumstances relating to the inspection, and the exercises which were demonstrated on the Post-SM KT360 during that inspection. This evidence was not disclosed in the affidavit of Dr Pizzari, but it necessarily reduces the weight which can be attached to Dr Pizzari’s evidence and to the evidence of the demonstrations. This is particularly because all of the relevant facts on which her expert evidence was based were not exposed in her evidence or otherwise proven. Further, the facts which were not revealed until the trial raise questions about the veracity of the demonstrations, and the conclusions which can be reached based on those demonstrations. They also raise questions about what other information surrounding these demonstrations was not before the Court.
291 This other evidence will now be considered.
292 First, Dr Pizzari spoke to the test subject before the exercises were performed and discovered that he was an employee of Vald, but she did not disclose that fact in her affidavit. Mr Ruddy (the test subject in question) was not selected by Dr Pizzari, and the person who selected him and the reasons that he was selected to be the test subject were not disclosed by the evidence. There was no suggestion that Mr Ruddy had been selected randomly; that he had not received any information from anyone at Vald about how to perform the exercises on the Post-SM KT360; that he was not aware of the purpose of the exercises he would be asked to perform or their relevance in showing that the Post-SM KT360 infringed the claims; and that he had not had any prior experience on the KT360 or the NordBord (the commercial embodiment of the invention), such that he represented a typical subject who could be asked to perform exercises on the Post-SM KT360. For obvious reasons, he was not independent.
293 The omission of such information is a serious deficiency. That is because Dr Pizzari’s evidence on infringement was predominantly dependent upon her observations and interpretation of what occurred during these demonstrations. Both experts gave evidence during the concurrent session about the performance of the exercises by Mr Ruddy: see, for example, T267/20–21; T286/32–34. Further, senior counsel for Vald cross-examined Dr Lovell by reference to the videos of the demonstrations: see, for example, T305/38; T316/36; T320/29. The absence of the information identified above reduces the weight which can be given to the demonstration of the Other Nordics by Mr Ruddy, and the evidence given by the experts by reference to those demonstrations, because it is not known (for example) whether the test subject was motivated to assist in demonstrating that the exercises could be performed or had been tutored by his employer as to how best to perform them in order to lead to a finding of infringement.
294 Second, according to Dr Pizzari, Mr Ruddy performed:
…upwards of 10, 15, maybe even 20 Nordic curls in various positions to test the device. And most people get very fatigued at that point…He performed some warm ups, and again this is from a memory of over a year ago, and then [we] trialled some different exercises…From memory, he performed some bilateral exercises as a warm up. And then he trialled the exercises that [are] in the affidavit…before videoing it.
295 This evidence tends to suggest that Mr Ruddy is not like “most people” in that he is stronger than most people; however, we do not know because the evidence discloses nothing about him other than what he looks like (from the videos) and that he is a Vald employee. The omission of such evidence is problematic because it would have been relevant to the issue of whether a reliable force measurement can be obtained from the performance of a One Leg Nordic on the KT360, being an issue addressed by the experts in the JER. As to this, Dr Lovell gave evidence that a person’s strength and familiarity with the exercises could impact either hip rotation or contribution by the contralateral (unsecured) limb to the force measurement which was obtained from a One Leg Nordic. Dr Pizzari also accepted that fatigue of the subject would affect the validity of the results recorded on the machine.
296 More importantly, Dr Pizzari’s evidence as referred to above reveals that:
(1) Mr Ruddy engaged in the exercise of performing up to 20 Nordic curls “in various positions” to test the device and so it appears that he, under Dr Pizzari’s supervision and potentially in the presence of Vald’s lawyers, sought to find ways of performing different exercises on the Post-SM KT360 which could then be said to fall within the claims. The nature of these tests, their duration and what they involved (including whether Dr Pizzari or any other person was involved in them), were matters which were not shown in the videos or addressed in Dr Pizzari’s affidavits;
(2) contrary to the impression given by the videos and by her affidavit evidence, Mr Ruddy was not asked to perform each of the Other Nordics by Dr Pizzari, which exercise he then immediately proceeded to perform as instructed. Instead, Mr Ruddy performed trials of the Other Nordics before the exercises were performed. However, the nature of these trials, their duration and what they involved (including whether Dr Pizzari or any other person was involved in them), were matters which were not shown in the videos or addressed in Dr Pizzari’s affidavits.
297 Third, Dr Pizzari was told (presumably by Dr Saunders), and then accepted after searching for it, that there was no protocol provided on the KT360 for performing an NHE. She gave evidence that she “selected knee flexion, I believe”. Later, when pressed on why she selected the knee flexion test, she agreed that she did so “because [she] considered that to be the closest parameter to performing a Nordic hamstring exercise”, despite having accepted that the knee flexion test is “quite a different exercise” to the NHE. She also agreed that she selected the knee flexion test because she knew it would activate sensors 2 and 6. Dr Pizzari could not recall how many protocols there were on the device but agreed that the protocols provided for a wide range of exercises to be performed on the KT360. Dr Pizzari also gave evidence that:
As I mooted, I was trying to select a protocol where I could have at least one outside sensor working to determine whether I could conduct those other exercises mentioned in the affidavit. And in fact, obviously not in the video, but in becoming acquainted with the device, we trialled a number of different protocols just to determine, you know, what they actually did in terms of how long they lasted from a time point of view, which sensors they activated and so on.
298 The trialling of different protocols (and what they were), and the selection of the knee flexion test protocol from amongst those protocols, were issues which were not addressed in Dr Pizzari’s affidavits.
299 Dr Pizzari did not agree with the proposition that the absence of a protocol on a device would indicate to her that that device was not meant to be used for that exercise, giving evidence to the effect that she would try to adapt the use of strength-testing equipment to produce the desired information. This aligned with one of the contentions of Vald in its infringement case, being that the absence of the NHE protocol on the Post-SM KT360 did not suffice to avoid infringement, because professionals such as Dr Pizzari and Dr Lovell would adapt their use of the Post-SM KT360 to conduct the desired testing. However, the ease or otherwise of such adaptation (including the length of time it would take to perform such an adaptation, the steps taken to adapt the Post-SM KT360 and the degree of difficulty involved in identifying those steps) is important evidence which is relevant to such a case.
300 For these reasons, to the extent that Dr Pizzari’s evidence conflicts with that of Dr Lovell concerning the Other Nordics, I prefer the evidence of Dr Lovell. I otherwise place little weight on the evidence contained in the videos of the demonstrations.
301 Many of the concessions by Dr Lovell during the concurrent evidence session and upon which Vald relies upon in its submissions related to the performance of the Other Nordics by Mr Ruddy during the demonstrations. For the same reasons, I place little weight on these concessions.
302 Further evidence emerged during the concurrent expert session which detracts from the findings which Vald seeks in relation to its claim of infringement.
303 First, Dr Pizzari accepted that the exercises which she had asked Mr Ruddy to perform on the Post-SM KT360 were ones which she had never asked anyone to perform on any other apparatus. This evidence only served to increase my concerns around the scientific veracity of the demonstrations; that is, rather than constituting independent evidence of the means by which the Post-SM KT360 could be used to perform the Other Nordics, the demonstrations were instead artificial, showing exercises which are unlikely to be performed on the Post-SM KT360.
304 Second, Dr Pizzari accepted that the aim of the demonstrations was to show that there would be some force measured irrespective of whether that measurement was accurate. Indeed, Dr Pizzari did not even record the force measurements let alone seek to assess the reliability and accuracy of the force data which arose from the various exercises performed by Mr Ruddy. Both experts agreed that determining whether results showing improvement in strength could be considered to be a clinically meaningful change is uncertain and, in Dr Pizzari’s view, would require further testing. Further, although Dr Lovell accepted that a video of one of the demonstrations shows there would be “force results” and “force measurements”, he questioned the reliability and validity of the results of those measurements. This was consistent with earlier evidence he gave during the concurrent evidence session that there are two main components when considering the accuracy of a measurement, being reliability (that is, consistency of the measurement from one test to the next) and measurement validity (that is, whether the test measures what it intends to measure). Dr Lovell then raised concerns around the exercises performed during the demonstrations in connection with these issues; in particular, he queried whether doing the exercises actually measures eccentric hamstring strength or measures a force from extraneous movement or stabilisation.
305 Having regard to this evidence, and in circumstances where the Patent is addressed to persons who have skills in sports medicine, and where it claims an apparatus for use in assessing strength of at least one knee flexor muscle of a subject, any conclusion that the Post-SM KT360 is able to produce a measurement of the strength of that muscle of any kind is insufficient to establish that the Post-SM KT360 is in fact an apparatus for use in assessing strength of at least one knee flexor muscle of a subject (i.e. within the meaning of integer 1.1). Applying the same reasoning, such a conclusion is insufficient to establish that the Post-SM KT360 uses a method of assessing strength of at least one knee flexor muscle of a subject (i.e. within the meaning of integer 18.1).
306 This conclusion is fortified by my earlier findings on the proper construction of the claims such that:
(1) an apparatus which falls within claim 1 (and its dependent claims) is one which, in use, is capable of assessing strength of at least one knee flexor muscle of a subject;
(2) a method which falls within claim 18 (and its dependent claims) is one which assesses the strength of at least one knee flexor muscle of a subject;
(3) an apparatus for use in assessing strength of at least one knee flexor muscle of a subject in integer 1.1 is only one which is capable of achieving that result if that assessment is a reliable and accurate one;
(4) a method of assessing strength of at least one knee flexor muscle of a subject in integer 18.1 only achieves that result if that assessment is a reliable and accurate one.
307 For these reasons, the evidence adduced by Vald failed to demonstrate that the Post-First SM KT360 and that the Post-Second SM KT360 has such capabilities.
308 This conclusion finds further support when one has regard to the evidence concerning the Other Nordics, to which I now turn.
7.5.3 Single Sensor Bilateral Nordic
309 As already observed, this was a bilateral Nordic curl in which the subject’s leg to be measured is secured in one c-shaped securing member and the subject’s other leg is constrained by the subject hooking it elsewhere, such as beneath the casing of the sensor unit.
310 The location of Mr Ruddy’s feet during the demonstration of this type of Nordic exercise is shown by this photograph:
311 After viewing Mr Ruddy performing this exercise in the video, Dr Lovell’s evidence in his second affidavit was that the subject has his knees at different angles, and in potentially different positions, with heels at different heights leading to different foot angles, and potentially differently flexed calves leading to different foot angles. Based on these observations, Dr Lovell expressed the opinion that the exercise would not provide accurate and reliable measurements. In particular, he considered that the different knee angles and heel heights would be likely to lead to a different pressure being placed on the sensor (connected to the arcuate component) than would be the case if both ankles/lower legs were each pressing into an arcuate component at the same height and restrained with the knee and ankle at the same angle (and knee flexors at the same length) in the way that the KT360 has been designed.
312 Dr Pizzari did not know whether the different knee angles and heel heights would be likely to lead to a different pressure being placed on the sensor than would be the case if both ankles were each pressing into the arcuate component at the same height as this would require further testing. However, Dr Pizzari did accept that the contribution of the contralateral knee flexor (that is, the leg that is not secured to the securing member) is not measured in this exercise and is therefore unknown.
313 Vald relies on Dr Pizzari’s evidence that, “If you do the same exercise in the same way each time, then it should be an accurate measure… theoretically, if you do the same exercise in the same way, then you should get a reliable measure”, with which proposition Dr Lovell did not disagree. Vald also relies on the evidence of Dr Pizzari that, given that the subject would be performing the Other Nordics in the same way, the results would be “reproducible and could be compared over time”.
314 The fundamental difficulty which I have with this evidence is that, because one leg is not being secured in a securing member but is constrained by hooking it elsewhere, the person conducting the testing will need to recall with precision where the contralateral leg was constrained on the previous occasion(s) that the testing was performed in order to ensure that the “same exercise” is done in the “same way” each time. Otherwise, based on Dr Pizzari’s own evidence, the results cannot be compared over time.
315 In any event, having regard to the evidence of Dr Lovell, which evidence I accept and whose evidence I prefer to that of Dr Pizzari for reasons already given, I am not persuaded that the performance of a Single Sensor Bilateral Nordic on the Post-SM KT360 would provide an accurate and reliable force measurement which is indicative of the strength of at least one knee flexor muscle acting in eccentric contraction.
316 The One Leg Nordic is a unilateral Nordic curl, where the subject’s leg to be measured is secured in a c-shaped securing member and the subject’s other leg is unsupported.
317 The location of Mr Ruddy’s feet during the demonstration of this type of Nordic exercise is shown by this photograph:
318 Once again, as one foot is located at a position which could differ on each occasion that the person performs the tests, the person conducting the testing will need to recall with precision where the contralateral leg was located on the previous occasion(s) that the testing was performed in order to ensure that the “same exercise” is done in the “same way” each time. Otherwise, based on Dr Pizzari’s own evidence, the results cannot be compared over time and clinically meaningful results cannot be obtained.
319 Dr Lovell considers that such an exercise is, in any event, not capable of providing an accurate measurement of the force being exerted by the knee flexors of the secured leg which is being measured.
320 Dr Lovell also critiques the performance of the exercise by Mr Ruddy, stating that the video shows:
(1) the subject unevenly placed in front of the KT360;
(2) the subject’s hips as uneven and partially rotated;
(3) the subject’s secured leg appearing to rotate and apply a degree of lateral force; and
(4) the subject descending significantly faster than he considers appropriate for the performance of an NHE.
321 Dr Lovell considers that, to be of value (which I interpret as meaning clinically relevant), NHEs must be conducted in a controlled manner and with a controlled descent, ensuring that the subject’s body is positioned correctly so as to avoid extraneous forces affecting the measurement. He contends that when the One Leg Nordic is performed on the KT360, it is not performed in this manner.
322 Dr Pizzari accepted that when the subject performed this exercise, the right arcuate member rotated in response to the forces applied in the single-legged Nordic exercise. Vald accepted that there might be some rotation of the securing member but sought a finding that such rotation would not impact the accuracy of the measurement. However, the evidence was insufficient to establish that such a finding should be made. Further, Vald did not address the issue concerning the rotation of the secured leg, or the other issues identified by Dr Lovell with the performance of the One Leg Nordic or unilateral Nordics generally (which are addressed in his affidavit evidence).
323 In particular, Dr Lovell opines in his second affidavit at [90] that:
…not only would performing (or attempting to perform) a single legged NHE on an apparatus such as that described in the Patent be a relatively high-risk exercise, but any force measured during such a unilateral NHE performed on the apparatus described in the Patent, with the contralateral leg unsupported and unsecured, would be unreliable. In my view, the force(s) measured would not be force(s) generated exclusively by the eccentric action of the hamstrings while performing that NHE. Depending to some extent on both the subject’s body mass and stature, the force detected would be likely to also include forces generated by other (extraneous) muscles/muscle groups arising from the subject keeping his or her body stabilised.
(Emphasis original.)
324 In the JER, Dr Lovell explains that:
Such measurements do not likely represent the strength of the knee flexor alone, they likely include those forces generated by the torso and contralateral limb in trying to support the descent and avoid body rotation during an unbalanced exercise ... Such imbalances would be further exacerbated when the orientation of support is of a different height or angle, as would be the case in the exercises described here using the KT360. Indeed keeping the trunk and hips neutral throughout is also considered a requisite feature of the Nordic lower…
325 Dr Pizzari’s opinions in the JER in response were premised on her observations of the demonstrations: see [8.8] and [8.9] JER. For the reasons already explained, little weight is given to this evidence.
326 Based on the evidence of Dr Lovell, which I prefer to the evidence of Dr Pizzari for the reasons already given, I am not prepared to make the further finding sought by Vald that “on the balance of probabilities [any] force measurement from unilateral Nordics is sufficiently reliable”. To the contrary, I am not persuaded that the performance of a One Leg Nordic on the Post-SM KT360 would provide an accurate and reliable force measurement which is indicative of the strength of at least one knee flexor muscle acting in eccentric contraction.
7.5.5 Two Sensor Bilateral Nordic
327 It will be recalled that this is a bilateral Nordic curl in which the positioning of one or both of the c-shaped securing members is adjusted from sensor 2 and/or sensor 6 to the middle sensor located between sensors 2 and 6, following which the subject’s legs are secured by respective securing members. Doing this would enable a subject to have both legs restrained, and while the central sensor would not measure any force, the outer sensor would do so.
328 The location of Mr Ruddy’s feet during the demonstration of this type of Nordic exercise is shown by this photograph:
329 As to this exercise, Dr Lovell raised concerns in his affidavit evidence that the subject’s knees and feet are laterally very close during such an exercise, whereas it is desirable that they be hip-width apart when performing an NHE. He said that this lack of lateral space leads to a subject staggering the position of his or her knees and lower legs where they fit into the arcuate components, which will inevitably result in the lower legs effectively having different length levers acting on the sensors. He said that this is likely to cause the force readings taken by each of the sensors in the measurement of an NHE to indicate a different force – even where the knee flexors of the subject have in effect exerted the same force. He concluded that this may result in an apparent asymmetry being indicated when none exists.
330 Dr Lovell’s evidence coincided with the unchallenged evidence of Dr Saunders that about 27cm (representing roughly hip or pelvic width) is the correct width apart for the lower legs to ensure that the NHE is performed correctly i.e., without inappropriate positioning of the thigh or shin that may lead to differential recruitment of knee flexors and bias the test in a manner that skewed results and/or made any comparisons between tests and/or individuals invalid.
331 At trial, Dr Pizzari gave this evidence about the Two Sensor Bilateral Nordic (which was described in [89(c)] of her second affidavit):
MR FITZPATRICK: Do you accept that the original spacing of sensors 2 and 6 on the KT360 for the performance of a Nordic hamstring exercise was to accommodate the average width of the human pelvis, that is, the distance between the hip joints.
DR PIZZARI: Yes.
MR FITZPATRICK: Thank you. And do you accept that this width provides a stable base on which to perform a Nordic hamstring exercise?
DR PIZZARI: Yes.
MR FITZPATRICK: And do you accept that this width between the two sensors minimises the risk of [abduction], medial and/or lateral rotation of the hip. I can break that down.
DR PIZZARI: I don’t think in either exercise where the sensors are 2 and 6, or middle and 6 or middle and 2, changes that very much. You still minimise all of those actions by being secured.
MR FITZPATRICK: Do you accept that, as a result of your changing the sensor from the end position to the middle position, that the space in between the two – the subject is essentially half that if the sensors had remained in their original positions, that is, positions 2 and 6.
DR PIZZARI: Without measuring, I accept that that’s probably close to true.
MR FITZPATRICK: Essentially half. Yes.
DR PIZZARI: Yes.
MR FITZPATRICK: And do you accept that, as a result of this, that the hip and knee angles of the subject are different in that configuration than if they had both feet secured in positions 2 and 6.
DR PIZZARI: I accept that the hip angles are different. I don’t accept that the knee angles are significantly different.
MR FITZPATRICK: So do you accept that that [difference] in hip angle is likely to affect muscle recruitment in the performance of the exercise?
DR PIZZARI: There’s a possibility it could affect it.
332 During the concurrent evidence session, Dr Lovell (twice) expressed concerns about the validity of the measurements taken from performance on the KT360 of the Two Sensor Bilateral Nordic: T293/37–41; T320/25–27. On the second occasion, he asked (rhetorically): “are we measuring what we intend to measure because our hips are not in a neutral width position?”
333 Having regard to the evidence of Dr Lovell, which evidence I accept and whose evidence I prefer to that of Dr Pizzari for reasons already given, I am not persuaded that the performance of a Two Sensor Bilateral Nordic on the Post-SM KT360 would provide an accurate and reliable force measurement which is indicative of the strength of at least one knee flexor muscle acting in eccentric contraction.
334 For these reasons, the evidence was insufficient to establish that the Post-First SM KT360 was, or the Post-Second SM KT360 is, an apparatus for use in assessing strength of at least one knee flexor muscle of a subject within the meaning of claim 1 (and its dependent claims) or (relevantly to the Post-First SM KT360) that it uses a method of assessing strength of at least one knee flexor muscle of a subject within the meaning of claim 18 (and its dependent claims).
335 This conclusion provides an additional reason to find that the infringement claims concerning the Post-SM KT360 must fail.
7.6 Whether exploitation of claims by sale of Post-First SM KT360
336 Vald contends that KangaTech’s “sale etc of the Post-SM KT360 involves KangaTech exploiting the invention in each of claims 1, 2, 4, 6, 9–14, 16 and 17 within the meaning of subparagraph (a) of the definition of “exploit” [in the Patents Act] and thus constitutes an infringement”.
337 In its closing submissions, Vald relied upon the evidence of Mr Dilena given under cross-examination in late July 2023. It submits that:
The Post-SM KT360 is supplied in a kit form (as a box): Dilena T98.33-34, 98.45-47; Ex 7. The customer then assembles the KT360 from the kit based on KangaTech’s instructions: 98.45-47. KangaTech admits that Ex 8 is the instructions provided to customers: T100.28-34.
Where (as here) a supply in kit form is the ordinary course of supply, a supply of a “complete set of parts” in kit form which when assembled falls within a product claim constitutes a sale (or hire) within the meaning of the term “exploit” as defined in the Act: Grove Hill Pty Ltd v Great Western Corp Pty Ltd (2002) 55 IPR 257 at [334]-[335] per Gyles J (with whom French and Dowsett J agreed); Windsurfing International Inc v Petit [1984] 2 NSWLR 196 at 207A-C.
338 However, as the Post-First SM KT360 was in existence between approximately January 2020 (after the first software modifications had been made) and July 2022, Mr Dilena’s evidence did not establish that the Post-First SM KT360 was supplied in a kit form, that it was a supply of a “complete set of parts” in kit form or that customers assembled it based on KangaTech’s instructions.
339 That is because Mr Dilena agreed with the proposition that the “KT360” is supplied in a box of the kind showed in a photograph (which became Exhibit 7) but he did not know if it had always been supplied like that, and he did not know whether all of the parts of the KT360 are supplied to the customer at once (although he made an unhelpful assumption that this was so, to which I attach no weight as it was plain that he was speculating).
340 Mr Dilena later agreed that the KT360 is supplied as a kit with the user to assemble it based on instructions. He was then shown instructions downloaded from the internet and dated 21 June 2023 (Exhibit 8). KangaTech admitted that the instructions which became Exhibit 8 are the instructions that “are provided”, but that was the extent of the admission.
341 Having regard to this evidence, the submissions by Vald insofar as they relate to the Post-First SM KT360 cannot be accepted as they rely upon facts which were not proven.
342 This aspect of the infringement case relating to the alleged exploitation of the Post-First SM KT360 therefore fails for this additional reason and in any event.
7.7 Whether infringement by supply of Post-SM KT360
343 Vald’s position is that by its “supply” of the Post-SM KT360, KangaTech has also infringed claims 1, 2, 4, 6, 9–14 and 16–20 pursuant to s 117 of the Patents Act.
344 Section 117(1) of the Patents Act relevantly provides: “If the use of a product by a person would infringe a patent, the supply of that product by one person to another is an infringement of the patent by the supplier unless the supplier is the patentee or licensee of the patent”.
345 “Supply” includes “supply by way of sale, exchange, lease, hire or hire-purchase” and any offers to do the aforementioned: see Schedule 1 to the Patents Act.
346 Section 117(2) defines the three circumstances in which s 117(1) applies. Vald relies on two of them, namely s 117(2)(b) and s 117(2)(c).
7.7.1 Section 117(2)(b) Patents Act
347 A person (the supplier) will infringe a claim of a patent within the meaning of s 117(2)(b) of the Patents Act if: (a) that person has “reason to believe” that the receiver of the product would put the product to a particular use; (b) that use of the product would infringe the patent; and (c) the supplied product is not a “staple commercial product”.
348 As to this last element, KangaTech admits that the Post-SM KT360 is not a staple commercial product.
349 A supplier need not have an actual belief that the product would be put to an infringing use. The test is an objective one, such that it does not matter whether KangaTech actually held the belief: Fuchs Lubricants (Australasia) Pty Ltd v Quaker Chemical (Australasia) Pty Ltd (2021) 284 FCR 174; [2021] FCAFC 65 at [340]–[346] (Beach, Moshinsky and Thawley JJ).
350 The question is whether there are factual matters known to the supplier that would lead a reasonable person to believe that the product will be put to an infringing use: Generic Health at [35] and [61]. The relevant “use” is the actual or intended use by the third party of the product being supplied: see Northern Territory v Collins (2008) 235 CLR 619; [2008] HCA 49 at [128]–[132] (Crennan J).
351 In this case, the relevant question is whether there are factual matters known to KangaTech that would lead a reasonable person to believe that the Post-SM KT360 would be used by customers to perform the Other Nordics, and thereby obtain a force measurement of at least one knee flexor muscle.
352 For the following reasons, I am not persuaded that there were such matters.
353 It was common ground that customers of KangaTech would be sports clubs and institutions with highly qualified scientists and training staff. KangaTech would be aware of its customer base. The experts called by the parties (i.e. a physiotherapist and a sports scientist) were therefore representative of the types of people who would be employed by KangaTech’s customers and who would be operating the Post-SM KT360.
354 Dr Pizzari’s evidence was that, if a protocol for the exercise she wanted a patient to perform existed on an apparatus, she would select that protocol but that if it did not exist, she would not regard the absence of a protocol as indicating the apparatus was not meant to be used for that exercise. Dr Pizzari further explained, “we try to use exercise strength-testing equipment to produce the information that we desire. So if I desired to do a Nordic hamstring exercise and get the strength from that, then I would be happy to modify the use of that device”.
355 However, Dr Lovell was more circumspect, only saying during the concurrent evidence session that “if the rigour of the assessment” was satisfactory he would “absolutely” use a different protocol to test something that did not have a specific protocol. He also gave evidence that:
[W]e often customise and bespoke… equipment… to get whatever it is that we need to measure, of course with the highest respect for the integrity of the data that we’re collecting. So… I would often customise the use of equipment, where possible, to get whatever research information I needed to get, or data.
356 That is, Dr Lovell would use a different protocol if it would provide him with clinically meaningful data. Having regard to his evidence concerning the Other Nordics, which I have accepted, Dr Lovell did not consider that the use of the Post-SM KT360 to perform the Other Nordics would provide him with such data. Further, it is apparent from his evidence that he did not consider that the performance of the Other Nordics on the Post-SM KT360 would be capable of assessing the strength of a knee flexor muscle.
357 A reasonable person in the position of KangaTech would know the capabilities of the Post-SM KT360, and would be aware that its customers, who are paying large sums of money to acquire or lease the Post-SM KT360, would be using the Post-SM KT360 to test athletes (and potentially elite athletes). A reasonable person would therefore know that its customers would be using the Post-SM KT360 for the purposes of obtaining clinically meaningful data (that is, data which is reliable and accurate).
358 A reasonable person in the position of KangaTech would therefore not believe that the Post-SM KT360 would be used in a way that would not provide reliable and accurate results.
359 As the performance of the Other Nordics on the Post-SM KT360 do not provide reliable and accurate results, being something which a reasonable person in the position of KangaTech would know, it follows that there are not factual matters known to KangaTech that would lead a reasonable person to believe that the Post-SM KT360 would be used by customers to perform the Other Nordics, and thereby obtain a force measurement of at least one knee flexor muscle.
360 This conclusion is fortified by the fact that:
(1) the ease or otherwise of adapting the Post-SM KT 360 to enable a subject to perform an NHE by means of the Other Nordics is uncertain having regard to the evidence adduced by Vald concerning the demonstrations. At the least, it appears that the selection of the knee flexion protocol and the devising of the Other Nordics was not a straightforward task; and
(2) the Other Nordics were exercises which Dr Pizzari had never asked anyone to perform on any apparatus,
which matters reduce the likelihood of a customer using the Post-SM KT360 to perform the Other Nordics.
361 The infringement case based on s 117(2)(b) of the Patents Act therefore fails in any event.
7.7.2 Section 117(2)(c) Patents Act
362 Relevantly to this case, a person (the supplier) will infringe a claim of a patent within the meaning of s 117(2)(c) of the Patents Act if (a) the use of a product by a person would infringe a patent and (b) the use of the product is in accordance with any instructions for the use of the product, or any inducement to use the product, given to the person by the supplier.
363 The relevant principles include as follows:
(1) There is a distinction between a document specifying a use and the provision of instructions for that use: see, for example, Hood v Bush Pharmacy Pty Ltd (2020) 158 IPR 229; [2020] FCA 1686 (Nicholas J) at [257]–[269];
(2) An inducement may include a statement that expressly or impliedly encourages or promotes the use of the relevant product in a manner that infringes. The language need not be “clear or unambiguous”: Hood at [215];
(3) A statement about what a user can do, or is capable of doing, with the product can constitute an “instruction” or “inducement” within s 117(2)(c);
(4) The use must be “in accordance with” any instructions or inducement. It follows that, if the instructions do not instruct the user to add the missing integer to the patented product or modify the product in order to achieve the missing integer, there will be no infringement.
364 The statement on which Vald relies for the purposes of s 117(2)(c) is the part of the error message which a user encounters if attempting to undertake unilateral testing by performing a bilateral Nordic, being the words “try again”. The error message is as follows:
365 Vald submits that this message invites the user to perform an NHE again, but by removing a force from sensor 2 and 6. It submits that, at the least, a finding should be made that the statement would impliedly encourage the user to perform one or more of the Other Nordics.
366 Dr Pizzari’s evidence in her second affidavit is that the wording of the error message would have given her encouragement to perform each of the Other Nordics, but does not explain why that was the case. For that reason, I attach no weight to this evidence.
367 There is, in any event, insufficient evidence that would enable me to conclude that customers would read into the error notice an instruction that the Post-SM KT360 should be used to perform an NHE again or to perform one or more of the Other Nordics.
368 That is because the user would already be aware that there was no protocol for the NHE on the Post-SM KT360. In that context, the user would not be attempting to have a subject perform an NHE using sensors 2 and 6 and if such an attempt was being made, then receipt of the error message would confirm what they already knew to be the case – that measurement of hamstring strength by means of an NHE was not able to be performed on the Post-SM KT360. That is, it would be discouragement rather than encouragement.
369 As to an implied instruction or inducement to perform the Other Nordics, the words “try again” are insufficient to give rise to such an instruction or inducement. They beg the question – try what again? The same thing? Something else? If so, what? To paraphrase the language of Yates J in Otsuka Pharmaceutical Co Ltd v Generic Health Pty Ltd (2012) 291 ALR 763; [2012] FCA 239 at [102]–[103], it is not sufficient that users will or might use the Post-SM KT360 in an (alleged) infringing manner after viewing the error message; there must be an instruction or inducement for them to do so.
370 The infringement case based on s 117(2)(c) of the Patents Act therefore fails in any event.
7.8 Whether KangaTech has authorised infringement of the claims
371 Vald’s position is that KangaTech’s sale etc of the Post-SM KT360 involves KangaTech authorising users to exploit the invention in the claims identified at [259] above, and thus constitutes an infringement.
372 Vald seeks a finding that, by its conduct in relation to the Post-First SM KT360 and the Post-Second SM KT360, KangaTech has authorised infringement of those claims. As part of this, Vald seeks an inference that “primary infringements have occurred”.
373 Having regard to the findings which I have made, I decline to draw that inference and to make that finding.
374 Vald has achieved partial success on its infringement claim in relation to the KangaTech Product and the Pre-SM KT360, and there will need to be a further hearing concerning relief.
375 Vald has failed in its infringement claim in relation to the Post-First SM KT360 and the Post-Second SM KT360.
376 KangaTech did not press its cross-claim in the event that the claims were construed in a particular way (which they have been) with the result that the cross-claim should be dismissed.
377 I will request the parties to confer and provide orders which reflect these reasons, and which address directions relating to the further conduct of this proceeding.
I certify that the preceding three hundred and seventy-seven (377) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Downes. |
Associate: