Federal Court of Australia

Perfect Day, Inc. v Commissioner of Patents [2025] FCA 270

ORDERS

THE COURT ORDERS THAT:

1.    By 4 April 2025, the parties are to confer as to the appropriate form of orders to give effect to these reasons, including the dispensation of costs of the appeal and any further application to amend Australian Patent Application No. 2015305271.

2.    By 4 April 2025, the parties are to provide to the Court:

(a)    a joint set of orders which may be made by consent;

(b)    to the extent that agreement has not been reached:

(i)    competing sets of proposed orders; and

(ii)    an agreed proposed timetable for the filing of any further submissions concerning those competing orders.

3.    The proceeding be listed for a case management hearing on a day after 4 April 2025, such date to be arranged in consultation with the Associate to Rofe J.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT

ROFE J:

Introduction

1    Perfect Day, Inc., is the applicant for the Australian Patent Application No. 2015305271, entitled “Compositions comprising a casein and methods of producing the same” (the Application).

2    Perfect Day appeals from the opposition decision, Fonterra Co-operative Group Ltd v Perfect Day, Inc. [2022] APO 59 delivered on 23 August 2022 (the Decision or D), in which the delegate found that the claims of the Application lacked support, and the specification did not disclose the invention in a manner which was clear enough and complete enough for the invention to be performed by a person skilled in the art, as required by ss 40(2)(a) and 40(3) of the Patents Act 1990 (Cth). Perfect Day was given two months to file amendments to the Application in an attempt to address these deficiencies.

3    On 13 September 2022, Perfect Day commenced proceedings in this Court seeking to appeal the Decision (the Appeal Proceeding). Perfect Day also filed two interlocutory applications in this matter, first on 2 March 2023 (the First Amendment Application) and second on 18 July 2024 (the Second Amendment Application), both seeking to amend the Application. I refer to the First Amendment Application and the Second Amendment Application together as the Amendment Applications. The final iteration of the claims of the Application, including as proposed to be amended, are set out in Annexure A to the Second Amendment Application. The orders sought by Perfect Day are for the amendments in the Second Amendment Application to be allowed, the Decision to be set aside, dismissal of the opposition, and the Application as amended to be allowed to proceed to grant.

4    For the reasons that follow, I consider that the claims of the Application, including in their amended form, lack support and the specification fails to 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 therefore should not proceed to grant.

The change in parties to the Appeal Proceeding

5    Fonterra Co-operative Group Ltd, the successful opponent, initially filed a Notice of Contention and appeared as the respondent in the Appeal Proceeding. However, it later sought, and was granted, leave to withdraw as the respondent on 13 April 2023.

6    As a consequence, the Commissioner of Patents became a party to the proceedings under r 34.23(2) of the Federal Court Rules 2011 (Cth).

7    Having regard to the interests of the public in ensuring that registration is not extended to invalid patents, the Commissioner has appeared in the Appeal Proceeding to assist the Court by presenting the view, contrary to that of Perfect Day, that any patent granted on the Application, or the Application as proposed to be amended, would be invalid on the grounds that it does not comply with ss 40(3) and/or 40(2)(a) of the Patents Act.

Broad overview of the Appeal Proceeding

8    By its proposed amendments, Perfect Day seeks to narrow the claimed invention in claim 1 to a food composition suitable as a dairy substitute comprising two identified recombinant milk proteins and not casein.

9    The Commissioner contends that the entire disclosure of the specification is directed towards a food composition that includes casein, so that the proposed amended claims to a food substitute which does not include casein lack sufficiency and support. The Commissioner also contends that there is no support for a food composition that includes two or more of the Listed Characteristics (as they are defined at [88] below) in claim 1.

10    The Application claims an earliest priority date of 21 August 2014 from a United States priority document. Therefore, the amendments to the Patents Act as made by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) apply.

11    The Application is currently entitled “Compositions comprising a casein and methods of producing the same”. Perfect Day also seeks to amend the title to “Food compositions comprising milk proteins and methods of producing the same”.

12    The field of the invention is said to be directed to dairy substitutes, methods of manufacturing the same, and compositions comprising animal-free milk fats and proteins for food applications, such as milk, butter, cheese, yogurt and cream.

13    The “Background of the Invention” begins by discussing mammal or mammalian produced milk. The Application notes that although mammal-produced milk, such as bovine milk, is considered by many to be an ideal source of nutrition, there are some downsides to it and its production, including environmental impacts of production, lactose intolerance, allergenicity and the presence of food borne pathogens.

14    The Application notes that existing dairy alternatives, such as soy, almond and coconut milks, fall short in both flavour and in functionality. While addressing environmental and health concerns, these non-dairy alternatives “almost universally fail to form” derivative products such as cheese, yogurt, cream or butter. What is said to be needed is a dairy substitute or composition that has desirable flavour and performance characteristics, minimises foodborne pathogens, and has a lower environmental impact in production while retaining the ability to be used for derivative or downstream applications of dairy milk and while providing a similar nutritional profile as a mammal or mammalian-produced milk.

15    The “Summary of the Invention” states that the “present invention” is based on the discovery that only a subset of components in mammal-produced milk can be used to generate a composition that has a similar flavour, a similar appearance, a similar nutritional value, a similar aroma, and a similar mouth feel of mammal-produced milk.

16    Milk proteins include β-casein, κ-casein, α-s1-casein, α-s2-casein, α-lactalbumin, β-lactoglobulin, lactoferrin, transferrin, and serum albumin. Of most relevance to the present Application are the casein proteins (which I will refer to globally as casein), the α-lactalbumin (ALA) and β-lactoglobulin (BLG) proteins and their recombinant equivalents, which shall be referred to as rALA and rBLG herein.

17    The Application describes six compositions “provided” by the invention (from page 3, line 1 to page 8 line 16). The first five compositions described are liquid compositions, the sixth composition (described at page 8, line 17) is a powder composition. Each composition provided is said to comprise at least κ-casein and β-casein. The Application states (at page 3, line 23 to 27) that:

In some embodiments of these compositions, the composition does not include at least one component found in a mammal-produced milk selected from the group of: lactose, bacteria, mycobacteria, allergens, viruses, prions, yeast, growth hormones, leukocytes, antibiotics, heavy metals, immunoglobulins, lactoferrin, lactoperoxidase, and lipase.

18    Casein is not identified as one of the components found in mammal-produced milk that may not be included in the composition of the invention.

19    The Application provides that, in some embodiments of any of the compositions described, “the composition further includes” ALA and/or BLG (at page 6, lines 16 to 19). A similar phrase is employed in relation to protein mixture compositions (at page 11, lines 23 to 26): “further includes one or more proteins selected from the group of: [ALA], [BLG]…”.

20    Further, the Application describes the following methods provided by the invention (from page 9, line 22 to page 11, line 26).

(a)    Methods of producing “a recombinant milk protein” that is unglycosylated or has a nonmammalian glycosylation pattern.

(b)    Methods of producing a micelle including a ß-casein and a κ-casein.

(c)    Methods of supplementing a mammal produced milk that include mixing into the milk at least one of a ß-casein; a κ-casein; and a micelle including a ß-casein and a κ-casein.

(d)    Methods of producing a composition that include, inter alia, sonicating a liquid including a protein mixture comprising ß-casein protein and κ-casein protein, or comprising micelles comprising ß-casein protein and κ-casein protein. Relevantly, the Application states (at page 11, lines 23 to 26) that:

In some embodiments of these methods, the protein mixture further includes one or more proteins selected from the group of: α-lactalbumin, β-lactoglobulin, α-s1-casein, α-s2-casein, lactoferrin, transferrin, and serum albumin.

(e)    “Also provided” is a composition produced by any of the methods described in the Application and a method of making butter, cheese, caseinate, or yogurt that includes: providing any of the compositions described within the Application; and producing the butter, cheese, caseinate, or yogurt using any of the compositions described within the Application as a starting material.

21    The Application states that “also provided are kits that include: (a) a mixture of one or more milk proteins, one or more fats, and one or more flavour compounds; and (b) a mixture of ash and at least one sweetening agent” (at page 12, lines 1 to 3). In some embodiments of the kits, “the one or more milk proteins are selected from the group of: β-casein, κ-casein, [ALA], [BLG] … and serum albumin” (at page 12, lines 4 to 6). Perfect Day relies on this reference as being a disclosure of the ALA and BLG proteins being in a food composition independently of casein.

22    The Application further provides that compositions may include “one or more isolated milk protein components” (at page 13, lines 9 to 10; page 15, lines 19 to 22 and page 30, lines 1 to 3). Perfect Day also relies on these references as being a disclosure of the ALA and BLG proteins being in a food composition independently of casein.

23    Advantages of the methods and dairy compositions of the invention are said to include reduction or removal of antibiotic residues, heavy metals, bacterial and adulterations commonly found in natural dairy products as well as reducing environmental impact.

24    The consistory clause for claim 1 is found from page 16, line 25 to page 16a, line 5 of the Application. This was included by way of an amendment to the specification dated 21 August 2019.

25    Relevantly, the following terms are defined in the Application (from page 17, line 11 to page 29, line 18).

(a)    “Milk protein component” is said to refer to proteins or protein equivalents and variants found in milk such as casein, whey or the combination of casein and whey, including their subunits, which are derived from various sources and as further defined within the Patent.

(b)    “Milk protein” refers to a protein found in a mammal-produced milk or a protein having a sequence that is at least 80% identical to the sequence of a protein that is found in a mammal-produced milk.

(c)    “Casein protein” is said to be an “art-known term” and represents a family of proteins that is present in mammal-produced milk and is capable of self-assembling with other proteins in the family to form micelles and/or precipitate out of an aqueous solution at an acidic pH level.

(d)    “Ash” is said to be an “art-known term” and represents one or more ions, elements, minerals and/or compounds that can be found in mammal-produced milk.

(e)    “Micelle” refers to a generally (or roughly) spherical supramolecular structure that exists as a dispersion within a composition. A micelle can have, for example, a surface that is composed of a charged outer layer. A micelle can encapsulate one or more biomolecules. For example, a micelle can encapsulate two or more proteins. A micelle can have diameter of between about 10nm and about 350nm. Additional aspects and characteristics of micelles are known in the art.

(f)    “Essentially free of” is used to indicate the indicated component, if present, is present in an amount that does not contribute, or contributes only in a de minimis fashion, to the properties of the composition. In various embodiments, where a composition is essentially free of a particular component, the component is present in less than a functional amount or in trace amounts.

26    The detailed description of the invention states (at page 29, lines 23 to 28) that:

The compositions provided herein provide for compositions that have a similar taste, mouth feel, aroma, and nutritional value as compared to a mammal-produced milk, but lack one or more of the components of a mammal produced milk that may be considered to be undesirable (e.g., allergens, lactose, antibiotics, hormones (e.g., stress hormones and/or growth hormones), heavy metals, bacteria (e.g., E. coli), viruses, and prions).

27    The importance of casein micelles for the optimum behaviour of milk is described at page 35, lines 13 to 15:

In bovine milk, casein or casein micelles usually makes up 2.5% of the entire mixture in suspension. If sufficient casein is not present the micelles, which are very important for the optimum behaviour of milk, will not form. Too much protein does not go into solution properly resulting in an undesirable mixture.

28    Whey proteins, as discussed in the Application (from page 37, lines 2 to 9), are said to be commonly known as the by-product of cheese and are also known to be one of the causes of allergies to milk. A typical whey composition is said to comprise a mixture of BLG and ALA, serum albumin, immunoglobulins, lactoferrin, and transferrin. In a phrase relied on by Perfect Day, the Application states (at page 37, lines 6 to 8) in “one embodiment, a select combination of whey proteins comprising [BLG] and [ALA] are used as the primary component”, although as the Commissioner notes, not the only component, of at least part of the milk protein component or composition. These include ALA, BLG, lactoferrin, transferrin and serum albumin. Professor Phillip Tong, an independent expert witness engaged by Perfect Day, gave evidence that whey proteins are also referred to as serum proteins.

29    A detailed description of the compositions provided by the Application is found from pages 45 to 67. Each of the compositions described comprise at least casein. The Application specifies that (at page 52, lines 6 to 10):

In some embodiments of these compositions, the composition does not include at least one component found in a mammal-produced milk selected from the group of: lactose, bacteria, mycobacteria, allergens, viruses, prions, yeast, growth hormones, leukocytes, antibiotics, heavy metals, immunoglobulins, lactoferrin, lactoperoxidase, and lipase.

(Emphasis added.)

30    Furthermore, the Application states (at page 58, lines 4 to 10) that:

In some examples of any of the compositions described herein can further include: a final concentration of [ALA and/or BLG] …

(Emphasis added.)

31    “Methods of making a composition” are described from pages 73 to 76. Each of the methods described include the use of a protein mixture comprising casein (from page 73, line 25 to page 76, line 6).

32    In some embodiments of these methods, the protein mixture is said “to further comprise” one or more proteins selected from the group of: ALA, BLG, α-S1-casein, α-S2-casein, lactoferrin, transferrin, and serum albumin (at page 75, lines 16 to 23) (emphasis added).

33    The specification also provides (at page 76, lines 9 to 17) for kits that include:

(a)    a mixture of one or more milk proteins (any one or more of the β-casein proteins, α-S1-proteins, α-S2-proteins, ALA, BLG, lactoferrins proteins, transferrin proteins and serum albumin proteins), one or more lipids, and one or flavour compounds; and

(b)    a mixture of ash and at least one sweetening agent.

34    Under the heading “Dairy substitute products” the Application states that, in some embodiments, whey compositions can comprise about 0.001% (at page 79, line 15).

35    The specification provides nine examples, none of which include any composition that does not include casein, or a composition that is specified to include ALA and BLG as the only milk proteins.

36    Table 4, as shown in example 3 (Milk formulation), depicts a milk formulation which has casein in the range 1–10% w/v (10–100 g/L) and whey proteins in the range 0–1% w/v (0–10 g/L). Accordingly, casein proteins must be present in this formulation, whereas whey proteins may be omitted.

37    Example 4 is described as a “preliminary proof of concept” and contains tables 5 to 9. Table 5 records the observations made in respect of three casein containing formulations. Following table 5, there is recorded the hypothesis that bad mouthfeel was due to the lack of whey protein (as none of the formulations contained whey proteins). Table 6 records the observations for four formulations, each of which contain casein. The hypothesis recorded under table 6 is that bad mouth feel was because of bad casein micelle formulation, the addition of calcium would allow the micelle to reform. Each of the formulations in tables 5 and 6 contained casein. There were no examples of formulations which contained only whey.

38    Example 6 relates to the recombinant production of milk proteins and includes the method for producing recombinant proteins including rALA, rBLG and casein, noting that the proteins produced by the yeast will either be non-glycosylated or have a nonmammalian glycosylation pattern.

39    Examples 7 (method of making a composition) and 8 (example formulations) all include formulations with casein. Example 7 describes a method for making an exemplary composition by reference to a flowchart in figure 9. The example formulations in example 8 are said to be made using the necessary modifications to the process described in example 7 and to have a similar taste and texture profile as whole milk, cream, high protein milk, fat-free milk, and sugar-free milk. The compositions of the examples are set out in tables 11 to 15. All compositions contain micellular casein.

40    Example 9 is said to be an exemplary composition, made by the presently described methods, and depicted in a photograph in figure 10.

41    The Application ends with 30 claims to food compositions. Claim 1 is the only independent claim. Claim 1 claims:

A food composition comprising:

(i)    a recombinant β-lactoglobulin protein and a recombinant α-lactalbumin protein, wherein one or both of the recombinant β-lactoglobulin protein and the recombinant α-lactalbumin protein comprises a sequence that is at least 90% identical to the bovine protein amino acid sequence and has been produced by a fungal cell;

(ii)    one or more sweetening agents;

(iii)    ash; and

(iv)    optionally, one or more lipids,

wherein:

the food composition has one or more characteristics of a dairy food product selected from the group consisting of: taste, aroma, appearance, handling, mouthfeel, density, structure, texture, elasticity, springiness, coagulation, binding, leavening, aeration, foaming, creaminess, and emulsification; and

the food composition does not comprise any other milk proteins than those in (i).

42    The latest version of the proposed amendments to the Application, among other changes, excludes cottage cheese and hard cheese from the food composition claimed in claim 1.

Delegate’s Decision

43    The delegate considered the person skilled in the art to comprise a team of food technologists, together with a microbiologist, with knowledge and skills in the preparation of recombinant proteins. The delegate considered that the person skilled in the art would have knowledge of milk proteins and skills in the preparation of dairy products and dairy substitutes, however the delegate did not consider that the person skilled in the art was limited to having direct experience in the use of fungal recombinant systems for the preparation of milk proteins: at D [14].

44    The delegate observed that claim 1 does not require that the food product is the same as, or even similar to, a “traditional” mammalian based dairy food product: at D [28]. The delegate noted that this was apparent from the definition of the food product having as few as one of the defined characteristics of a dairy food product, and the absence of an explicit requirement that the composition possesses any particular level of palatability. The delegate then concluded that, given that the claims require as little as a single property in common with the corresponding dairy food product, the resulting dairy food substitute product may be a poor substitute, but it is a substitute nonetheless: at D [35].

45    The delegate considered that the specification is directed to dairy substitute foods that comprise casein protein or proteins. In so doing, the delegate expressly rejected Perfect Day’s submission that examples 6 to 8 would teach the person skilled in the art to make a dairy substitute food product comprising only rALA and rBLG as the sole milk proteins: at D [87].

46    The delegate went on further to observe that:

[91]    … with the exception of the consistory clause that was added during examination, there is no specific disclosure of dairy substitute food product comprising the claimed combination of [BLG] and [ALA], ash, sweetener and (optional) lipid. There is no explicit statement that casein can be omitted, or that the recombinant proteins can replace casein proteins. The proof of concept provided by examples 3 and 4 teaches that the subset of components of milk required to obtain a satisfactory milk substitute product includes micellar casein, whey protein, sugars and ash.

…

[93]    I see no suggestion in the specification that [ALA] and [BLG] provide such characteristics or can be used to replace casein and provide properties such as structure, texture, mouthfeel and aggregation properties traditionally attributed to casein. All teaching is towards casein being used in combination with whey proteins, and rather than possessing aggregation properties traditionally attributed to casein, the whey proteins retain the typical properties of whey including that they remain in solution at low pH while casein proteins do not…

47    Ultimately, the delegate concluded that all claims lacked support: at D [96].

48    Regarding sufficiency, the delegate considered at D [109] that:

… the specification provides no guidance, or even a suggestion, that [ALA] and/or [BLG] could be used as a replacement for casein and would provide the structure, texture, mouthfeel and aggregation properties traditionally attributed to casein. The lack of guidance, the uncertainty in the research and the associated trial and error that would inherently be required to work the present invention based on a specification that essentially describes a completely different invention would, based on the evidence before me, constitute an undue burden. While the applicant sought to rely on the evidence of Mr Jhala to establish that compositions according to the claims could be prepared, I consider his evidence shows that it would not be a matter of routine experimentation based on the knowledge provided by the specification. Additional information about the functional properties of the proteins would be required to work the invention across the full scope of the claims, which was not provided by the specification, nor part of the common general knowledge. This would appear to require a process of discovery involving further research and invention, rather than a matter of routine trial and error to validate the disclosure of the specification.

49    The delegate concluded that the specification did not disclose the invention in a manner which was clear enough and complete enough for the invention to be performed by a person skilled in the relevant art: at D [111]. Perfect Day was provided an opportunity to file amendments to attempt to overcome the deficiencies.

Amendment Applications

50    The Court has the power to hear and determine an application made by a patentee to amend a patent application pursuant to ss 105(1A) and 112A of the Patents Act in the course of an appeal from the decision of a delegate of the Commissioner: Meat and Livestock Australia Ltd v Branhaven LLC (2020) 154 IPR 402 at [17]–[20], [91]–[93] (per Kenny, Nicholas and Burley JJ). Moreover, in contrast to the Commissioner’s power to amend a patent upon application under s 104 of the Patents Act, the Court’s power to decide upon proposed amendments pursuant to s 105(1A) is discretionary in nature: Meat & Livestock Australia Ltd v Cargill, Inc (No 2) (2019) 139 IPR 47 at [342] (per Beach J).

51    On 16 December 2022, Perfect Day informed the Commissioner of its intention to apply to the Court for an order under s 105(1A) of the Patents Act to amend the complete specification of the Application.

52    On 6 January 2023, the Commissioner advised Perfect Day that the proposed changes to the specification and claims, later outlined in the First Amendment Application, were allowable under s 102 of the Patents Act. Following this confirmation, Perfect Day filed the First Amendment Application on 2 March 2023.

53    In support of its motion to amend the Application, Perfect Day relies on two affidavits of Ms Naomi Kate Pearce, Principal of its legal representatives, Pearce IP, who filed three affidavits in total in this proceeding. Ms Pearce made an affidavit dated 2 March 2023 in support of the First Amendment Application (Pearce No. 2) and another dated 2 September 2024 (Pearce No. 3) in support of the Second Amendment Application.

54    In Pearce No. 2, Ms Pearce explained the reasons for Perfect Day requesting the initial amendments to the Application, which included to narrow the issues to be determined at the hearing, by addressing minor errors in the description, reinforcing, and more specifically, identifying the scope of protection sought.

55    On 8 July 2024, Perfect Day notified the Commissioner that it intended to apply for further amendments to the Application and provided a copy of the proposed changes.

56    In Perfect Day’s subsequent attempt to amend the Application, Ms Pearce outlined the following reasons in Pearce No. 3 at [14]–[15] to support the additional proposed changes to the Application:

[14]    The version of the amended Patent Application appearing in the Advertisement and attached to the Second Amendment Application marks-up the further amendments sought pursuant to the Second Amendment Application against a copy of the Patent Application in which the amendments sought in the First Amendment Application had been accepted (the Further Amended Patent Application). For completeness, I note that one of the amendments sought to the specification in the First Amendment Application (including as advertised in the Australian Official Journal of Patents Supplement) was erroneously omitted from the Further Amended Patent Application.

Reasons for the Proposed Amendments

[15]    I am informed by Ms Harsha [Rohatgi], a patent attorney at Perfect Day, that Perfect Day seeks the Proposed Further Amendments in order to narrow the issues to be determined at the hearing, and that each of the Proposed Further Amendments is made to the Patent Application for the following specific reasons:

(a)    claim 1 is narrowed to require that both the recombinant β-lactoglobulin and α-lactalbumin proteins comprise a sequence that is at least 90% identical to the bovine protein amino acid sequence and has been produced by a fungal cell in accordance with claim 2 (and hence claim 2 is deleted);

(b)    the words “other than a cottage cheese and a hard cheese” are included in claim 1 to qualify and narrow the claimed “food composition”;

(c)    the word "leavening" is deleted from claim 1 to narrow the claim;

(d)    amendments corresponding to those made to claim 1 (described in (a) to (c) above) are made to the consistory clause for consistency;

(e)    claims 9 and 10 are deleted to narrow the claims;

(f)    claim 11 is amended to correct obvious typographical errors and corresponding amendments are made to the specification; and

(g)    claims 18, 25, 32 and 35 are deleted or narrowed to qualify that the cheese of the claimed food composition is a whey cheese and excludes a cottage cheese.

57    On 11 July 2024, the Commissioner indicated to Perfect Day that no opposition was intended regarding the grant of the amendments, following notification that Perfect Day sought leave to further amend the specification.

58    On 15 July 2024, the Court made orders by consent, including a timetable for the Second Amendment Application. The Second Amendment Application was subsequently filed on 18 July 2024. No opposition was raised by the Commissioner regarding the proposed amendments, nor was a request made to be heard on the Second Amendment Application. Moreover, in addressing this application, the Commissioner did not raise any matters relevant to the Court’s exercise of its discretion.

59    Overall, both Amendment Applications and respective sets of proposed amendments to the Application aim to refine and narrow the scope of the claims. The key amendments are as follows.

(a)    Updates to the title and the description: the title has been amended to “Food compositions comprising milk proteins and methods of producing the same”. Additionally, terminology and references in the description have been corrected to clearly define the invention as a food composition suitable as a dairy substitute.

(b)    Addition of a consistory clause: the phrase “other than a cottage cheese or hard cheese, that is suitable as a dairy substitute, said food composition” has been inserted under the “Background of the Invention”, effectively creating a consistory clause for claim 1.

(c)    Omission of leavening characteristic: Perfect Day’s expert witness, Professor Tong, explained that leavening is generally not applicable to dairy products but rather to bakery products. At this point, it is useful to again set out the language of claim 1, this time with the proposed changes marked up:

A food composition, other than a cottage cheese or a hard cheese, that is suitable as a dairy substitute, said food composition comprising:

(i)    a recombinant β-lactoglobulin protein and a recombinant α-lactalbumin protein, wherein one or both of the recombinant β-lactoglobulin protein and the recombinant α-lactalbumin protein comprises a sequence that is at least 90% identical to the bovine protein amino acid sequence and has been produced by a fungal cell;

(ii)    one or more sweetening agents;

(iii)    ash; and

(iv)    optionally, one or more lipids,

wherein:

the food composition has one or more characteristics of a dairy food product selected from the group consisting of: taste, aroma, appearance, handling, mouthfeel, density, structure, texture, elasticity, springiness, coagulation, binding, leavening, aeration, foaming, creaminess, and emulsification; and the food composition does not comprise any other milk proteins than those in (i).

(Emphasis added. Single underline denotes the first set of proposed amendments, while the double underline denotes the second set of additional proposed amendments.)

(d)    Correction of errors in website references within the specification.

(e)    Narrowing of claims to specify that the composition must be a dairy substitute containing recombinant proteins (rBLG and rALA from fungal cells), one of which must have a sufficiently high sequence correspondence to bovine protein. Additional limitations include ash content and alternative fungal cell types.

(f)    Typographical corrections: various minor typographical errors and misspellings throughout the document have been corrected.

(g)    Administrative oversight addressed: an oversight in the second round of amendments, where certain amendments were not carried forward from the first round, has been addressed. No objections were raised regarding this issue.

(h)    Clarification of composition requirements: it has been explicitly stated that the food composition must include a sweetening agent, ash, and optionally a lipid, while exhibiting at least one characteristic of a dairy product to ensure its suitability as a substitute.

60    Both sets of amendments were advertised in accordance with r 34.41 of the Rules in the Australian Official Journal of Patents on 19 January 2023 and 1 August 2024, respectively.

61    No factors relevant to the exercise of the Court’s discretion were raised. There was no evidence of any equivalent amendments being made to related foreign applications, nor was there any evidence of any decision in relation to a foreign counterpart that would require any of the amendments to be made in order to defeat a validity challenge.

62    The Commissioner has indicated that the first set of proposed amendments is allowable and does not object or seek to be heard in relation to the second set of proposed amendments. No factors relevant to the Court’s exercise of its discretion were raised in relation to the proposed amendments, as such I will allow the proposed amendments to the Application. From here on, these reasons discuss the Amended Application unless otherwise noted.

The Appeal

63    The question for the Court is whether the Amended Application discloses the invention in a manner that is clear enough and complete enough for a person skilled in the relevant art to perform it, and whether the claims are clear, succinct, and supported by the matter disclosed in the specification, such that the Amended Application complies with ss 40(2)(a) and 40(3) of the Patents Act.

64    As no other grounds of invalidity have been asserted, for the purposes of this appeal, the claimed invention is taken to be novel, inventive and have utility.

Nature of appeal

65    It is well-established that an appeal from a decision of the Commissioner by their delegate is not an appeal in the strict sense. Rather, it is conducted as a hearing de novo in the original jurisdiction of the Court: Commissioner of Patents v Sherman (2008) 79 IPR 426 at [18] (per Heerey, Kenny and Middleton JJ). Essentially, the Court will stand in the shoes of the Commissioner to consider the opposition afresh, and in regard to the Amended Application.

Onus

66    Perfect Day contends that it does not bear the onus of proving that the Amended Application is sufficient and supported. Perfect Day highlights the lack of any evidence which indicates that the person skilled in the art could not have made food compositions as claimed, using the specification, without undue burden or experimentation.

67    The Commissioner accepts bearing the burden of establishing the grounds of opposition in the Appeal Proceeding. In this regard, the Commissioner, in contending that an analogous situation arises here, drew attention to the observations of Nicholas J in ToolGen Incorporated v Fisher (No 2) [2023] FCA 794, where his Honour discerned at [19] that:

Even though the burden of proof is on the respondents, circumstances may still arise in which [the patentee’s] failure to adduce any evidence or any sufficient evidence on some particular matter (eg. a fact which it asserts was common general knowledge) may ultimately lead the Court to conclude, on the totality of the relevant evidence, that the invention cannot be performed across the full scope of the claims without undue burden. This may be particularly true in relation to matters in respect of which [the document] is wholly silent.

(Emphasis added.)

Evidence

68    In Cadbury Schweppes Plc v Effem Foods Pty Ltd (2006) 69 IPR 584, Lindgren J acknowledged at [16] that an applicant is not required to submit evidentiary material that was before the Commissioner or any other evidence relating to the merits of the appeal or potential grounds of opposition. In accordance with this practice, Perfect Day did not initially file any evidence.

69    However, following receipt of the Commissioner’s submissions in answer, Perfect Day sought, and was granted leave, to file evidence from its independent expert witness, Professor Tong. Perfect Day was later granted leave to file a second affidavit of Professor Tong, which clarified and expanded upon certain matters in his first affidavit. Perfect Day relies on both affidavits of Professor Tong, affirmed on 7 July 2024 (Tong No. 1) and 24 November 2024 (Tong No. 2), respectively. Professor Tong was cross-examined during the hearing by video.

70    The Commissioner sought to tender certain paragraphs from submissions filed on behalf of Perfect Day in the opposition proceedings as admissions regarding what was, and was not, common general knowledge as at the priority date. Specifically, the Commissioner referenced [112]–[113], [116]–[118] and [133] of Perfect Day’s written submissions. Perfect Day did not object to the Commissioner’s reliance on these paragraphs but disputed the conclusions the Commissioner sought to draw from them.

71    The Commissioner cautioned against accepting what it described as Perfect Day’s “unsupported assertions of fact”, and submissions based on evidence previously presented to the delegate. There was extensive expert evidence before the delegate in the opposition proceedings; however, none of that evidence is before me in this appeal, nor have any of the experts from the opposition been called to give evidence. The Commissioner submits that, in these circumstances, any evidence or submissions based on the evidence before the delegate should be disregarded, as Perfect Day has neither sought leave to tender that evidence nor made any of those witnesses available for cross-examination. I accept this submission.

Professor Tong

72    Professor Tong is a Professor Emeritus at California Polytechnic State University and is self-employed as a consultant to the food and dairy industry.

73    Professor Tong has over 35 years of experience in dairy food science and technology, with 28 years in academia. He earned his Bachelor of Science in Food Science and Technology from the University of California, Davis, in 1977 and gained early industry experience at Foremost Research and Development Center, where he worked on cultured dairy products. He later pursued a Master of Science and a PhD at Cornell University, with his doctoral research focusing on membrane filtration of whey in cheesemaking.

74    Throughout his career, Professor Tong held various academic and industry positions, including roles at the New Food Products Group of Clorox, Refrigerated Products Group of the Kraft Technology Center, and Cal Poly. He joined Cal Poly in 1986 as an Associate Professor in the Dairy Science Department and later became a professor, a position he held until his retirement in 2016. At Cal Poly, he played a key role in establishing the Dairy Products Technology Center, led research initiatives, and developed outreach programs for the dairy industry. His research, including research that he has supervised, focussed on a range of processes to improve the quality and functionality of dairy foods such as dried dairy ingredients, fluid and fermented milks, frozen desserts, cheddar cheese, butter and cream cheese. Relevantly, Professor Tong has worked with various milk proteins including whey proteins (including BLG and ALA) and the influence of milk proteins on qualities such as colour, flavour and viscosity.

75    Beyond academia, Professor Tong served in leadership roles for organisations such as the American Dairy Products Institute and the California Creamery Operators Association. He has also provided consultancy services to dairy companies and legal firms, addressing technical matters related to dairy science. His contributions to dairy research and education have been widely recognised through various industry awards and memberships in professional organisations.

76    The Commissioner accepted that Professor Tong was representative of a member of a team comprised of persons skilled in the art.

Person skilled in the art

77    The person skilled in the art is not a reference to a specific person but is a legal construct drawn by reference to the available evidence. As French CJ explained in AstraZeneca AB v Apotex Pty Ltd (2015) 257 CLR 356 at [23]:

… The notional person is not an avatar for expert witnesses whose testimony is accepted by the court. It is a pale shadow of a real person — a tool of analysis which guides the court in determining, by reference to expert and other evidence, whether an invention as claimed does not involve an inventive step.

78    Moreover, the skilled addressee will be a person who also has knowledge and experience in the field of the invention and who will bring to the reading of the relevant document the background knowledge and experience available to those working in that field: Neurim Pharmaceuticals (1991) Ltd v Generic Partners Pty Ltd (No 5) [2024] FCA 360 at [70] (per Nicholas J).

79    The legal construct may be a single person or may be a team of persons “whose combined skills would normally be employed in that art in interpreting and carrying into effect instructions such as those which are contained in the document to be construed”: General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd [1972] RPC 457 at 485 (per Sachs LJ, Buckley and Orr LJJ). The hypothetical construct is unimaginative and without inventive capacity.

80    The delegate found that the person skilled in the art was a team of food technologists together with a microbiologist with knowledge and skills in the preparation of recombinant proteins: at D [14]. The delegate’s person skilled in the art was accepted by Perfect Day and the Commissioner, and I see no reason to depart from that finding. It was common ground that Professor Tong was representative of a member of a team comprised of persons skilled in the art.

Against the background of the common general knowledge set out at 7.6 above, it is not plausible that the invention claimed in claim 1 can be worked across the full scope of the claim (a composition with two, three or all of the Listed Characteristics) without undue burden.

81    What is typically referred to as the common general knowledge attributed to the person skilled in the art is “the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old”: Minnesota Mining and Manufacturing Company v Beiersdorf (Australia) Limited (1980) 144 CLR 253 at 292 (per Aickin J).

82    Perfect Day admits that each of the following matters were part of the common general knowledge at the priority date of the Application.

(a)    Native BLG protein and ALA were purified from milk only for research purposes rather than making food.

(b)    Whey, whey protein isolates and whey protein concentrate (which each contain BLG and ALA in addition to other mammalian proteins) were used as food ingredients (and as the main component of a limited number of particular products, such as ricotta). These other mammalian proteins included serum albumin, immunoglobulins, lactoferrin and transferrin, as well as other proteins such as glycomacropeptide, residual casein and casein derivatives.

(c)    Casein was an important component of dairy products and also had properties, contributing to, for example, structure of dairy food products.

(d)    It was not obvious, and there was no reasonable expectation, that a subset of proteins of mammal produced milk, namely ALA and BLG expressed in fungal systems, could be used to generate a dairy substitute food composition.

83    Perfect Day also admits that each of the following matters were not common general knowledge at the priority date of the Application.

(a)    The use of isolated milk proteins as ingredients to make dairy substitute food compositions.

(b)    The use of BLG protein and ALA protein (in native or recombinant forms) as ingredients to make dairy substitute food compositions.

(c)    The use of isolated forms of native or rBLG protein and rALA protein as the sole protein component in dairy substitute food compositions.

(d)    That a subset of proteins of mammal produced milk, namely ALA and BLA proteins expressed in fungal systems, could be used to generate a dairy substitute food composition.

84    The Commissioner noted that Perfect Day had previously acknowledged in its written submissions before the delegate that, at the priority date, it was common general knowledge that isolating native BLG and ALA proteins was both difficult and costly. These proteins were typically purified from milk for research purposes rather than for food production. Additionally, it was widely accepted that casein was an essential component of dairy products, contributing to their structure and functional properties.

85    Professor Tong, in course of his cross-examination, shed light on the knowledge and experience of a person skilled in the relevant art. His evidence disclosed that the person skilled in the art would not have had experience with milks that lacked casein, nor would they have encountered a synthetic milk product containing only ALA and BLG without any other milk proteins. Additionally, the person skilled in the art would have had no experience in producing synthetic milk using solely ALA and BLG, and they would never have used rALA or rBLG to create a food composition or for research purposes. Furthermore, they would not know whether rALA and rBLG shared the same properties as their native counterparts.

86    Moreover, the person skilled in the art would recognise that casein micelles play a crucial role in the behaviour of milk across various applications. Professor Tong understood “behaviour” to refer to the characteristics of milk. Micelles contribute to the mouthfeel of cow’s milk, and synthetic milk without casein micelles would likely exhibit a different texture and structure. Additionally, milk without casein would be incapable of forming a rennet curd, as whey proteins do not form micelles and possess distinct properties compared to casein in milk. If sufficient casein is not present, the micelles will not form.

87    Finally, the person skilled in the art would have considered, and would still consider today, that the challenges involved in replicating all the characteristics of animal-free milk are “tremendous”.

Construction

88    Claim 1 of the Amended Application claims a food composition suitable as a dairy substitute which has “one or more” characteristics of a dairy food selected from the group consisting of 17 listed characteristics (the Listed Characteristics).

89    Professor Tong explained that the Listed Characteristics provides an exhaustive list of characteristics which include physical properties, sensory properties and properties which can be measured in a laboratory by analytical techniques. Professor Tong expanded upon these groupings of the properties in the Listed Characteristics:

(a)    The sensory (or organoleptic) characteristics are taste, aroma, appearance and texture.

(b)    The properties quantifiable using analytical techniques are density, structure, elasticity, springiness, coagulation, binding.

90    According to Professor Tong, not all of the Listed Characteristics were applicable to each claimed food composition. For example, he did not consider that the properties of springiness and elasticity were applicable to beverages and instead would be more commonly used in the context of cheeses. References to “characteristics” within these reasons will refer to the traits specified in the Listed Characteristics.

91    An issue emerged during the hearing as to the construction of claim 1, in particular the phrase “one or more” used in relation to the Listed Characteristics, and whether the claim covered a food composition suitable as a dairy substitute that had:

(1)    one of the Listed Characteristics;

(2)    more than one of the Listed Characteristics; or

(3)    all of the Listed Characteristics.

92    Perfect Day contends that claim 1 claims a food composition that has one of the Listed Characteristics, not a food composition having all the Listed Characteristics or even a minimum number of Listed Characteristics. In contrast, the Commissioner propounds a broader construction in which the claim encompasses a food composition with one Listed Characteristic, more than one Listed Characteristic or all the Listed Characteristics.

93    Senior counsel for Perfect Day sought to illustrate the propounded construction with a reference to infringement of the claim. In his submission, the claim would be infringed if a product had one of the Listed Characteristics, even if it had more than one. Whilst that might be true, the patent applicant has chosen to use the phrase “one or more” in relation to the Listed Characteristics, rather than “one of”, and construction is not driven by infringement.

94    I consider that the claim encompasses a food composition suitable as a dairy substitute that includes only one of the Listed Characteristics, as well as a food composition that has two or more of the Listed Characteristics, or indeed all of the Listed Characteristics. This broad scope of the claim has ramifications for the Commissioner’s sufficiency and support challenges.

95    Perfect Day submitted that the Commissioner’s sufficiency challenge, as articulated in the Commissioner’s Amended Grounds of Opposition, did not involve a challenge based on the enablement of a food composition which had more than one of the Listed Characteristics, i.e., a food composition on the spectrum of having from two to all of the Listed Characteristics. I will return to this in section 7.9 below.

Support

96    Section 40(3) of the Patents Act requires that the claim or claims must be “supported by matter disclosed in the specification”. Support requires that the claims defining the patent should themselves be supported by matter disclosed in the specification.

97    Section 40(3) in its current form was introduced following the passage of the Raising the Bar Act. In Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd (2023) 176 IPR 336 at [161], Perram J noted that both ss 40(3) and 40(2)(a) are ‘ambiguous’ within the meaning of s 15AB(1)(b)(i) of the Acts Interpretation Act 1901 (Cth), and as such, the Court is authorised to look to materials beyond the Patents Act, including Explanatory Memoranda, to ascertain the meaning of the requirements.

98    Item 9 of the Explanatory Memorandum to the Raising the Bar Act notes that the Patents Act was amended to replace the “fair basis” requirement with a “support” requirement. Referring to European and United Kingdom (UK) authorities, the Explanatory Memorandum describes “support” as picking up the following two concepts:

There must be a basis in the description for each claim; and

The scope of the claims must not be broader than is justified by the extent of the description, drawings and contribution to the art.

99    In Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) (2020) 155 IPR 1, Burley J considered the law of support in Australia from [544] onwards. At [547], Burley J noted that the approach outlined in Schering Biotech Corp’s Application [1993] RPC 249 at 252–3 broadly encapsulated the support obligation under s 40(3) of the Patents Act. Justice Burley at [547] in Merck endorsed Aldous J’s assessment of the support requirement in Schering Biotech at 252–3, where Aldous J said:

[T]o decide whether the claims are supported by the description it is necessary to ascertain what is the invention which is specified in the claims and then compare that with the invention which has been described in the specification. Thereafter the court’s task is to decide whether the invention in the claims is supported by description. I do not believe that the mere mention in the specification of features appearing in the claim will necessarily be a sufficient support. The word “support” means more than that and requires the description to be the base which can fairly entitle the patentee to the monopoly of the width claimed.

100    The question of whether a disclosure in a patent application fairly entitles the patentee to a monopoly of the width claimed calls for an assessment of the patentee’s contribution to the art, which must be weighed against the scope of the patentee’s monopoly as defined by the claims. The monopoly, according to European and UK authorities, must be justified by the technical contribution to the art that arises from the disclosure of the specification: ToolGen at [396].

101    Discussion of s 40(3) is often focussed on the breadth of the claim. However, some claims may also lack support because the claim includes a feature not disclosed in the specification, or omits a feature that is disclosed, resulting in a lack of support because the invention claimed is materially different from the invention disclosed: Calix Ltd v Grenof Pty Ltd (2023) 171 IPR 582 at [128] (per Nicholas J).

102    As to the requirement of an enabling disclosure in the context of the support obligation, the technical contribution to the art, at least in the case of a product claim, is the product which can thereby be made as a result of the disclosure. Relevantly, Nicholas J observed the following in ToolGen at [410]:

… it is difficult to see how a claim to an invention for which there was no enabling disclosure could meet the support requirement. In such circumstances, the scope of the monopoly defined by the claim could not be justified by the technical contribution to the art …

103    The Commissioner submits that the claimed invention lacks support on two bases. First, the Commissioner contends that the body of the specification does not support the claims to food compositions comprising BLG and ALA and no other milk proteins. The invention, as defined in the claims, is fundamentally different from the invention disclosed in the body of the specification and there is no enabling disclosure as to how to make such food compositions, such that the invention as claimed is not supported by the technical contribution to the art.

104    The Commissioner contends that the invention described in the specification, properly characterised, is broadly a food composition that includes casein and may further include other milk proteins, and methods of making the same. Whereas, properly characterised, the invention claimed in claim 1 is a food composition that comprises rALA and rBLG as the only milk proteins and does not include casein.

105    The Commissioner observes that, save for the consistory clause, there is no mention in the Amended Application of a food composition that is suitable as a dairy substitute comprising BLG and ALA and no other milk proteins and there is no description of any method for making such a food composition.

106    Second, the Commissioner contends that the technical contribution of the invention described in the specification does not support the scope of the invention claimed. The Commissioner submits that there is no support in the specification for a food composition which has more than one, or all of the Listed Characteristics.

107    Perfect Day submits that the invention claimed is not “fundamentally different from the invention disclosed in the body of the specification” — it is one of the inventions described and claimed in the Application. While the body of the specification must be read as a whole to ascertain the invention which is described and claimed, there may be a number of inventions or aspects thereof described, not all of which are claimed. In the present case, the claims are far narrower than the description in the specification. That is a common and legitimate practice. Thus, Perfect Day maintains that the invention, as narrowly claimed, is disclosed and supported. Perfect Day relies on the consistory clause, and corresponding claim 1, and the references in the Application set out at [21] above.

108    As to the Commissioner’s second challenge, that a composition with more than one (or all) the Listed Characteristics is not supported, Perfect Day submits that when the claims are read in context, they are to a narrow invention which is disclosed and supported in the specification. The Listed Characteristics do not go to the essence of the invention. The claimed dairy substitute food composition does not have to be a good dairy substitute, it might only have one of the Listed Characteristics, but if that was the important characteristic to replicate in the dairy substitute, then that was enough. The combination of all the Listed Characteristics goes beyond what the patent applicant asserts as being the essence of the invention. According to Perfect Day, the technical contribution to the art is a dairy substitute food composition consisting of ALA and BLG and no other milk proteins that replicates a characteristic of the dairy food it seeks to substitute.

109    Perfect Day contended that it would be possible to redraft claim 1 into 16 different claims that each claimed a food composition consisting of ALA and BLG and no other milk proteins, with one of the Listed Characteristics. That these claims would be enabled on the evidence, demonstrated that finding the current claim 1 to be not supported (or insufficient) would be a triumph of form over substance.

110    However, the flaw in this submission is that each of the 16 proposed claims would define a different invention from the one currently claimed. Splitting the claims in this manner would remove any claim to a food composition comprising combinations of more than one, or all of the Listed Characteristics — combinations that are currently captured within the existing form of claim 1.

111    The Commissioner acknowledged that, following amendment, the Amended Application will disclose an embodiment of the claims. The Commissioner notes that it is one single embodiment amongst the many thousands of embodiments in the specification, and as such it does not change the disclosure in the specification when read as a whole. Perfect Day contends that one embodiment plus the consistory clause should be an end to the debate as to whether the claimed invention is disclosed and supported in the specification. The fact that there are many other embodiments simply does not matter.

112    During oral submissions, senior counsel for Perfect Day sought to illustrate their contention by drawing attention to the observations of Nicholas J in Tramanco Pty Ltd v BPW Transpec Pty Ltd (2014) 105 IPR 18. Reliance was placed on [207] where his Honour expressed discomfort with applying the principles developed by the High Court in Kimberly-Clark Australia Pty Limited v Arico Trading International Pty Limited (2001) 207 CLR 1 to test a claim of this sort. Justice Nicholas gave the example of a claim for a method of producing one or more of outcomes A, B or C which might be infringed if the alleged infringer used the method to produce outcome A, but not outcome B or C at [207]:

… Whether there is infringement in such a case will depend upon (inter alia) the proper construction of the claim and, in particular, whether it requires the use of the method to produce only one or more of outcomes A, B or C, as opposed to all three of them. Assuming the former construction (in the present case it appears to have been assumed by both parties at the trial and on appeal that claim 1 is to be construed in this way), it would seem to me to be wrong in principle to hold that the description of the invention is sufficient if the specification enables the use of the method to achieve outcome A, but not outcomes B or C. It would be inconsistent with the purposes of the Act to confer a monopoly on a patentee for a method of producing any of outcomes A, B or C, if the patentee’s disclosure only enabled the use of the method to produce some of those outcomes.

113    The specification of the Application describes six compositions listed below.

(a)    Composition 1, which contains ҡ‐casein protein, β‐casein protein, lipids, flavour compounds, sweetening agents, ash and does not include an animal derived component.

(b)    Composition 2, which contains ҡ‐casein protein, β‐casein protein, lipids, flavour compounds, sweetening agents and ash. Further, this composition does not include at least one component found in a mammal‐produced milk; includes at least one component not present in a mammal‐produced milk; and/or includes a higher or lower concentration of at least one component as compared to the concentration of at least one component in a mammal‐produced milk.

(c)    Composition 3, which contains ҡ‐casein protein that is unglycosylated or has a nonmammalian glycosylation pattern, β‐casein protein that is unglycosylated or has a nonmammalian glycosylation pattern, lipids, flavour compounds, sweetening agents and ash.

(d)    Composition 4, made up of micelles including a ҡ‐casein protein and a β‐casein protein, where the ҡ‐casein protein and the β‐casein protein are unglycosylated or have a nonmammalian glycosylation pattern.

(e)    Composition 5, being supplemented milk compositions. Also provided are compositions including: a mammalian‐produced milk or a processed mammal‐produced milk; and one or both of a ҡ‐casein protein that is unglycosylated or has a nonmammalian glycosylation pattern, and a β‐casein protein that is unglycosylated or has a nonmammalian glycosylation pattern.

(f)    Composition 6, which are dry compositions, being powder compositions. These contain ҡ‐casein protein, β‐casein protein, sweetening agents, lipids, ash, water, unglycosylated and/or has a nonmammalian glycosylation pattern, and/or the β‐casein protein is an unglycosylated is an unglycosylated and/or has a non‐mammalian glycosylation pattern.

114    On the plain wording of claim 1, I consider that it claims, at its broadest, the combination of all the Listed Characteristics. That is what must be supported by the disclosure in the specification for claim 1 to endure.

115    First, it is necessary to consider whether there is a basis in the description for each claim.

116    As Perfect Day contends, the requirement of support (and sufficiency) must be judged by reference to the invention as claimed, not by reference to statements made in the specification. That accords with the well accepted principle of construction, that there be no glosses drawn from the specification in construing the claim. It is the invention as claimed which must be supported by the disclosure in the specification for the purposes of s 40(2)(a) of the Patents Act and which must be disclosed and enabled by the disclosure in the specification for the purposes of s 40(3).

117    Perfect Day relies on the consistory clause (and claim) and the references to the Application set out at [21] above as providing support for the invention.

118    As the Explanatory Memorandum makes clear, the intention of the Raising the Bar Act was to ‘raise the bar’ on patentability. The requirement of ‘support’ replaced the old requirement of ‘fair basis’. Given the intention to ‘raise the bar’, it would be a strange result if a claim that would not be fairly based prior to the implementation of the Raising the Bar Act, however, could satisfy the support requirement following its introduction merely through coincidence of language with a consistory clause which is inconsistent with the disclosure in the specification when read as a whole.

119    Prior to the Raising the Bar Act, disclosure in a consistory clause, was not sufficient to provide fair basis where a reading of the specification as a whole revealed a different invention. What was required was a real and reasonably clear disclosure in the body of the specification of what was claimed. A consistory clause inconsistent with that real and reasonably clear disclosure was, in truth, only loose or stray remarks and did not provide fair basis by mere coincidence of language: Lockwood Security Products Pty Limited v Doric Products Pty Limited (2004) 217 CLR 274 at [69] and [91] (per Gleeson CJ, McHugh, Gummow, Hayne and Heydon JJ).

120    According to the Explanatory Memorandum, the first concept picked up by ‘support’ is that there must be a basis in the description for each claim. That description ought to be, at a minimum, a real and reasonably clear description of the kind discussed in Lockwood at [69] with respect to the previous ‘fair basing’ requirement, rather than a mere coincidence of language between a consistory clause and the claim. As noted in Schering Biotech by Aldous J at 252–3, “mere mention” is not enough, and ‘support’ requires the description to be a base which can fairly entitle the patentee to the monopoly of the width claimed.

121    Putting aside the Listed Characteristics for a moment, properly characterised, the invention claimed is a food composition that comprises rALA and rBLG proteins as the only milk proteins and does not include casein (or any other milk proteins). I consider this to be a different invention to the invention disclosed in the specification when read as a whole, which describes a food composition that includes casein and may further include other milk proteins, and methods of making the same. It is this food composition which is said to achieve the environmental and health benefits alleged in the specification.

122    Save for the consistory clause (and its corresponding claim), as Professor Tong accepted, there is no mention in the Application of a food composition that is suitable as a dairy substitute comprising BLG and ALA and no other milk proteins, nor is there any description of making such a food composition, or any such compositions in the examples. As the Commissioner noted there are six compositions disclosed in the specification. Each of those disclosed compositions includes casein (in one form or another).

123    Specifically, in respect of synthetic milk, the body of the specification positively recommends that:

(a)    if sufficient casein is not present, micelles will not form;

(b)    micelles are very important for the optimum behaviour of milk; and

(c)    bad casein micelle formation can be attributed to bad mouth feel in synthetic milk products.

124    In addition to the consistory clause, Perfect Day cites the selected phrases noted above in section 4 as providing support for the invention claimed. The strongest of those is the discussion under the heading “Whey Proteins” which noted one embodiment in which a select combination of whey proteins “comprising BLG and ALA” are used as the primary component “of at least a part of the milk protein component or composition”. As the Commissioner submits, that is not a disclosure of BLG and ALA being the only milk proteins in a composition. I do not accept that “used as the primary component of at least a part of the milk protein component or composition” conveys an inferential disclosure of a composition comprising ALA and BLG and no other milk proteins. In the context of the extensive specification which describes compositions and provides examples which all include casein, an absence of casein (and all other milk proteins) from an embodiment comprising BLG and ALA would require express wording to that effect.

125    The disclosure in the specification read as a whole is of a food composition that includes casein and may further include other milk proteins, and methods of making the same. Other than the coincidence of language from the presence of the consistory clause, I do not consider that the specification read as a whole provides a description of the invention claimed in claim 1. The selected phrases relied upon by Perfect Day to support the invention claimed in claim 1 are no more than loose or stray remarks. The invention claimed in claim 1 is a different invention to that described in the specification when read as a whole. For that reason, I do not consider that the invention claimed is supported by the description.

126    It is also necessary to consider whether the monopoly claimed is justified by the technical contribution to the art that arises from the disclosure of the specification.

127    In the case of a product, the contribution to the art is the product which is enabled to be made by the disclosure: Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] RPC 22 at [56], [58] (per Briggs LJ with Reed, Hodge and Sales LJJ agreeing), cited with approval by the Full Court in Jusand at [173] (per Perram J, Nicholas J and McElwaine J agreeing).

128    Perfect Day contends that the technical contribution to the art is a dairy substitute food composition consisting of rALA and rBLG and no other milk proteins that replicates a Listed Characteristic of the dairy food it seeks to substitute. It is Perfect Day’s position that the claimed invention is founded on the surprising discovery that rALA and rBLG proteins, when expressed in fungal systems, can be used to create a dairy substitute food composition with the flavour and functional properties of the dairy food. This concept is said to be counter to what was known and accepted in the common general knowledge and, relevantly, it is submitted that the evidence showed that this was not an obvious approach and that there was no reasonable expectation of success. Perfect Day notes that the delegate found there to be an inventive step.

129    As outlined above, Perfect Day contends that the invention is a narrow one, that the essence of the invention (or technical contribution) is not the Listed Characteristics, but the production of a dairy substitute composition that replicates the desired characteristic or property of the dairy food sought to be substituted (be it milk, cheese, yogurt etc), using only rALA and rBLG and no other milk proteins. That contention should be rejected.

130    Whilst that may be the invention Perfect Day intended to claim, I do not consider that is what is actually claimed by claim 1. The ordinary meaning of the claim claims a food composition comprising rALA and rBLG and no other milk proteins that has one or more of the Listed Characteristics. In other words, the claim encompasses compositions which might have one of the Listed Characteristics, as well as compositions which have two or even all of the Listed Characteristics.

131    Professor Tong’s evidence makes it clear that what is included within the scope of the claimed invention — a composition with all of the Listed Characteristics — exceeds the technical contribution the Application makes to the art. Professor Tong agreed that he would have considered at the priority date, and would still consider today, that the challenges of recreating at least all of the Listed Characteristics of animal-free milk were “tremendous”.

132    Against the background of the common general knowledge set out at 7.6 above, it is not plausible that the invention claimed in claim 1 can be worked across the full scope of the claim (a composition with two, three or all of the Listed Characteristics) without undue burden.

133    Also, as discussed further below, not all the Listed Characteristics are applicable to all possible dairy substitute compositions and hence, the claims, as framed, do not sufficiently disclose the appropriate characteristics of the claimed invention.

134    The Application does not teach the person skilled in the art how to make any food composition comprising rBLG and rALA and no other milk proteins. None of the examples are to compositions other than ones containing casein. Nor was a dairy substitute comprising rBLG and rALA a matter of common general knowledge.

135    Professor Tong gave evidence that despite there being no formulation described in the Application which he could follow from start to finish, he could make a composition within claim 1 which had one characteristic “reminiscent” of cow’s milk, yogurt, cream, butter and ricotta. In Tong No. 2, he expanded upon his evidence to note which characteristics he considered were not applicable to particular dairy substitutes.

136    Professor Tong gave evidence about how he would make a formulation within the claim. The Commissioner contended that the process he described was not implementing the teaching of the Application, or working from any invention described in the Application, but was instead applying his knowledge gained from his life’s work to make something in the scope of the claims independently of what the Application taught him, including about the importance of casein.

137    In order to make the substitute dairy composition, the person skilled in the art would have to make multiple formulations in multiple different ways and then test them to assess their characteristics, adjusting the ingredients and/or processing condition variables depending on the test results. Professor Tong considered that there would be challenges along the way that would need to be addressed by using the available alternative technologies that might be available.

138    Professor Tong agreed that the presence of micelles contributed to the mouthfeel of cow’s milk. He agreed that the person skilled in the art would know that casein micelles are very important for characteristic behaviour (i.e., optimum behaviour) of milk for many applications. The Application tells the reader of the importance of micelles that “[i]f sufficient casein is not present the micelles, which are very important for the optimum behaviour of milk, will not form”: Application at page 35, lines 13 to 15. However, as Professor Tong agreed, the Application does not tell the reader how to achieve the same “ultra” structural aspects of milk (micelle structures) in the absence of casein.

139    In cross-examination, Professor Tong suggested micelles could form in milk without casein because “in some cases, you can do some post-translational modifications of other – other milk proteins that could result in some micellar formation”. Professor Tong did not know whether rALA and rBLG would do that and would have to carry out research to determine whether that was the case. The Application did not tell him how to do that and he would not have otherwise known how to do that.

140    The Application also does not tell the reader how to achieve coagulation with rennet or other enzymes in the absence of casein. Professor Tong would have to do experiments to convince himself that coagulation occurs. Ultimately, he accepted that he could not make a product that resembled a traditional enzymatic curd in its appearance, or structure.

141    It became clear from Professor Tong’s evidence that different considerations applied depending upon the nature of the dairy substitute composition sought to be produced: whether it be milk, milk powder, infant formula, ice cream, hard cheese, yogurt, cream, ricotta, curd, crème fraiche, frozen custard and so on. Different considerations also applied to the Listed Characteristics sought to be replicated depending upon the particular dairy substitute composition to be produced. For example, Professor Tong considered that the properties of elasticity, springiness or leavening were not apt for beverages, and the characteristics of binding, coagulation, elasticity, springiness or leavening were not applicable to butter.

142    For these reasons, I consider that claim 1 of the Amended Application lacks support.

143    Section 40(2)(a) of the Patents Act provides that a complete specification must 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 art.

144    Section 40(2)(a) requires that the complete specification make the necessary disclosure. Since the claims form part of the complete specification, they may contribute to the disclosure. The disclosure obligation relates to the invention as claimed: ToolGen at [175]. What the invention is depends on the proper construction of the claim.

145    In ToolGen, Nicholas J recognised at [192] that s 40(2)(a) requires that the invention be disclosed in the specification. His Honour discussed the nature of the disclosure at [193] in the context of the disclosure in a priority document in order to found priority. However, given that the priority disclosure requirement in s 43(2A) uses the same wording as s 40(2)(a), I consider that Nicholas J’s observations are equally apposite to the disclosure requirement in s 40(2)(a). Adapting them to the s 40(2)(a) requirement; it is not sufficient for the specification to provide a starting point from which the person skilled in the art may transition from one invention to another by the use of the common general knowledge. The mere fact that it would be obvious to the person skilled in the art to use the disclosure in the specification to produce what is claimed is not enough if, properly characterised, the disclosure in the specification and the claim are for different inventions: ToolGen at [193].

146    The question is whether the complete specification as a whole discloses the invention claimed and provides an enabling disclosure of the invention claimed. As I discussed above in relation to support, I consider that the invention disclosed in the specification when read as a whole is different to the invention claimed in claim 1.

147    Whether an invention is disclosed in a manner which is clear enough and complete enough depends on whether, given what is contained in the specification, the person skilled in the art can readily perform the invention without undue burden or experimentation beyond the ordinary steps of trial and error, or the need for further invention: Calix at [118]; Jusand at [157(a)]; Cytec Industries Inc v Nalco Company (2021) 162 IPR 202 at [149] (per Burley J). See also ToolGen at [167]–[192] and [383].

148    The Commissioner makes two sufficiency arguments. The first is that the invention claimed in the specification — a dairy substitute food composition which includes casein — is not that disclosed in the specification when read as a whole. Second, that the specification gives the person skilled in the art no meaningful assistance as to how to produce the claimed products, in particular where the claimed products include combinations of the Listed Characteristics. The Application provides at best a ‘starting point’ from which the person skilled in the art is left to rely on their common general knowledge alone.

149    Perfect Day objected to the Commissioner’s second argument, saying that it was not raised in the Amended Grounds of Opposition. The Commissioner submitted that the particulars to the sufficiency challenge in the Amended Grounds of Opposition were broad enough to encompass the second argument. The Commissioner’s senior counsel also observed that the Commissioner’s submissions dated 12 July 2024 made it clear that the Commissioner was contending that the person skilled in the art could not perform the invention as claimed over the whole of the scope of the claim without undue experimentation. In particular, this included “food compositions that have one (or more) of” the Listed Characteristics.

150    I consider that Perfect Day was sufficiently on notice of the second sufficiency argument. Professor Tong’s evidence directly addressed the issue. For example, in his first affidavit, Professor Tong gave evidence as to the making of a food composition of the type claimed in claim 1 that has one or more characteristics of a selection of dairy products (including cream, infant formula, butter and cheese).

151    According to Perfect Day, the relevant range of the claims for the purposes of sufficiency and support is “a food composition that is suitable as a dairy substitute … having one or more of the characteristics of a dairy food product selected from an identified list of characteristics”. Perfect Day contends that as the food composition of claim 1 is not claimed to replicate the characteristics of milk entirely, just that it be suitable as a dairy substitute by possessing one of the Listed Characteristics, satisfaction of the sufficiency requirement should not require more than just one (at a time) of the Listed Characteristics to be enabled.

152    Perfect Day relies on the disclosure in the consistory clause (and corresponding claim) as being sufficient disclosure of the invention in the specification for the purposes of s 40(2)(a). Perfect Day submits that the evidence of Professor Tong shows that a food composition with one of each of the Listed Characteristics can be produced without undue burden or experimentation beyond ordinary trial and error.

153    Relevantly, the person skilled in the art:

(a)    would know that casein was an important component of dairy products;

(b)    would not know of the use of BLG and ALA as the sole protein components in dairy substitute food compositions;

(c)    would have no reasonable expectation that ALA and BLG proteins expressed in fungal systems could be used to generate a dairy substitute food composition; and

(d)    would understand from the Application that in relation to synthetic milk:

(i)    if sufficient casein is not present, micelles will not form;

(ii)    micelles are very important for the optimum behaviour of milk; and

(iii)    bad casein micelle formation is attributable to bad mouth feel in synthetic milk products.

154    Professor Tong gave evidence about making a formulation within the claim. Despite there being no formulation described in the Application which he could follow from start to finish, Professor Tong was confident that he could make a composition within claim 1 which had one Listed Characteristic of cow’s milk.

155    The Commissioner submits that the process described by Professor Tong was not implementing the teaching of the Application, or working from any invention described in the Application, but was instead applying his knowledge gained from his life’s work to fill in the gaps in order to make something in the scope of the claims independently of what the Application taught him, including about the importance of casein.

156    The Commissioner contends that, at best, the Application provides information which the person skilled in the art might use as a starting point when seeking to implement the invention claimed in claim 1, and that the person skilled in the art seeking to implement the claimed invention, even with that starting point, would face an undue burden and prolonged research, enquiry or experimentation in order to implement the invention.

157    It is the Commissioner’s contention that Professor Tong’s evidence does not establish that the person skilled in the art could perform the invention as claimed over the whole of the scope of the claim without undue experimentation.

158    The starting point in the Application is a casein containing composition as there is no description of how to produce any composition in the specification of any kind of dairy substitute composition comprising rALA and rBLG and no other milk proteins, which could be used as a starting point. Nor are there any compositions provided in the examples other than casein containing compositions.

159    Professor Tong described his “starting point” in making a milk substitute composition as simply replacing the casein (and presumably all other milk proteins) in the milk product, from table 11 in example 8 of the Application, with rALA and rBLG. He agreed that he could not predict the properties of the composition in advance.

PR. TONG: I could vary the amounts [of rALA and rBLG] and see what properties would occur as a result of that variation in the concentration of the protein in solution.

MS BEATTIE SC: And that’s not something you would predict in advance, so you would have to, what, prepare some formulations with different amounts and test them?

PR. TONG: That’s right.

MS BEATTIE SC: You don’t just replace the casein with ALA and BLG?

PR. TONG: I think that might be my starting point. Whether that would result in properties that were what I was trying to achieve, that would remain to be seen, based on the trial.

160    Professor Tong agreed that he would not know whether, as a result of post-translational modification (glycosylation), the rALA and rBLG might form micelles, when he knew that the native forms would not. He also agreed that the Application provided no information as to whether post-translational modification caused rALA or rBLG to form micelles. The only information provided by the Application as to micelle formulation (and their importance) related to casein containing compositions.

161    The Application also does not tell the reader how to achieve coagulation with rennet or other enzymes in the absence of casein. Coagulation of rennet is necessary for cheese. Professor Tong hypothesised that one option to explore could be adding heat to the enzymatic coagulation. He agreed that he would have to do experiments to convince himself that coagulation occurs. Ultimately, he accepted that he could not make a product that resembled a traditional enzymatic curd in its appearance, or structure.

162    It was also apparent from Professor Tong’s evidence that issues might arise during the conduct of the trials and studies that would be required to produce a dairy substitute requiring modification of the experimental ingredients or conditions and that the difficulties encountered were likely to vary depending on the dairy substitute product sought to be produced, and which of the Listed Characteristics were sought to be replicated in that dairy substitute:

MS BEATTIE SC: …so in order to make the synthetic product we’ve been describing, you would have to make multiple formulations in multiple different ways and then test them to assess their characteristics?

PR. TONG: I think so. That’s pretty typical of any kind of developmental work that you would do would be to conduct trials and do the studies to determine what the targets would be.

…

MS BEATTIE SC: Is it fair to say that the application doesn’t tell you how you should address those challenges?

PR. TONG: Again, I guess I would refer to the idea that it says it’s – it’s known in the art, and so, like in the case of mouthfeel, there are many ingredients that can contribute to certain mouthfeel characteristics and certain modifications in ingredient processing that can contribute to mild field characteristics. So those are – are practised in the formulation of – of many food products.

163    Many experiments might be required to produce a particular dairy substitute composition with the desired characteristic or characteristics:

MS BEATTIE SC: Do you accept that, in order to make this product you’ve described, it would require a large number of experiments – in the realm of 100?

PR. TONG: That’s hard to say. You know, I think we – we have a starting point, and, really, until I have actually done some of this work, since this is such a novel area, it really would be hard to know until I’ve started to initiate the work.

MS BEATTIE SC: Thank you, Professor? ---

PR. TONG: But it would be – you know, I think it would be more than 10. It may not take 100.

164    In Calix, like in the present case, the complete specification did not provide any working examples of the claimed invention. However, in Calix, the claims were found to be sufficient because the method of performing the invention was itself set out in the claims in suit, which was itself a well-known method of producing hydroxide slurries: at [123]. Moreover, Nicholas J there found the claimed method to be obvious: at [112]–[117]. As noted above, there is no obviousness challenge here.

165    The Application provides no guidance to the person skilled in the art seeking to perform the invention by making a dairy substitute composition with two or more of the Listed Characteristics. In order to make a dairy substitute composition with two or more of the Listed Characteristics, the person skilled in the art would need to undertake a process of prolonged testing, enquiry and experiment. It would not be the work of a non-inventive person skilled in the art, rather, requiring an exercise of inventive skill or ingenuity or undue effort. Accordingly, I consider that claim 1 lacks sufficiency. The specification does not disclose the invention claimed in claim 1 in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art.

166    As I observed above in relation to support, the difficulties encountered during the trials and experiments required to produce a dairy substitute will depend upon the particular dairy substitute sought to be produced and the characteristic sought to be replicated in that substitute.

167    Professor Tong gave evidence that he considered he could produce a number of dairy substitute compositions with one of the characteristics. However, he also acknowledged that he would not be able to produce some, noting that not all the Listed Characteristics were appropriate for each possible dairy substitute. During cross-examination, Professor Tong used the example of Havarti as a soft, whey-based cheese to illustrate this point. While most of the Listed Characteristics would be applicable, others such as aeration and foaming, would not be applicable.

MS BEATTIE SC: …I’m asking whether you could produce a food composition that has all of the characteristics you’ve just mentioned of a semi-soft cheese? ---

PR. TONG: At the same time or ---

MS BEATTIE SC: Yes, at the same time in one product?

PR. TONG: I think that in any type of cheese making, you – you have trade-offs between one character versus another, even within a variety of Havarti. So if you want to make it have more springiness, you’re going to sacrifice on creaminess. So to – to say that you can’t have all of these, I would say you would have aspects of all of them, but you would – in a typical cheese making, you accentuate some of those characteristics over another for the type of market or target market that you’re trying to reach.

MS BEATTIE SC: And so is the answer to my question no? You could not make a product that has all of those characteristics you mentioned in a single synthetic cheese – whatever you call it?

PR. TONG: Well, as I said before, those that I mentioned, a cheese made that – that I described in this affidavit would have the characteristics that I mentioned.

168    As I have found claim 1 to lack sufficiency on my construction that it encompasses dairy substitute compositions with two or more of the Listed Characteristics, I do not propose to work through the permutations of possible dairy substitutes and any of these characteristics to determine what, if any, particular combinations of a dairy substitute composition with one Listed Characteristic is enabled on the evidence.

Disposition

169    It follows that claim 1 of the Amended Application lacks support and sufficiency and for those reasons the Amended Application should not proceed to grant with the claims in their amended form.

Associate:

Dated:    28 March 2025