Fonterra Co-operative Group Ltd. v Perfect Day, Inc
[2022] APO 59
•23 August 2022
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Fonterra Co-operative Group Ltd. v Perfect Day, Inc. [2022] APO 59
Patent Application: 2015305271
Title:Compositions comprising a casein and methods of producing the same
Patent Applicant: Perfect Day, Inc.
Opponent: Fonterra Co-operative Group Ltd.
Delegate: Leslie F. McCaffery
Decision Date: 23 August 2022
Hearing Date: 19 May 2022 by video conference
Catchwords: PATENTS – opposition to the grant of a patent under section 59 – consideration of information filed pursuant to Regulation 5.23 – inventive step – clear enough and complete enough disclosure – support – utility – opposition successful – claims lack support – specification is not clear enough and complete enough to be performed by the person skilled in the art – applicant given 2 months from date of decision to propose amendments – costs awarded.
Representation: Patent attorney for the applicant: Linda Govenlock of Allens Patent & Trade Mark Attorneys
Counsel for the opponent: Claire Cunliffe
Patent attorney for the opponent: Tim Jackson of AJ Park
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2015305271
Title:Compositions comprising a casein and methods of producing the same
Patent Applicant: Perfect Day, Inc.
Date of Decision: 23 August 2022
DECISION
The opposition is successful.
The claims lack support under section 40(3).
The complete specification does not 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 (section 40(2)(a)).
Applicant given two (2) months from the date of this decision to file amendments to attempt to overcome the deficiencies.
Costs according to Schedule 8 are awarded against the applicant, Perfect Day, Inc.
REASONS FOR DECISION
Background
Patent application 2015305271 (the application) in the name of Perfect Day, Inc. (the applicant) was filed on 21 August 2015 under the provisions of the Patent Cooperation Treaty. The application claims an earliest priority date of 21 August 2014.
Following examination, the application was advertised as accepted on 26 September 2019. A notice of opposition was file by Fonterra Co-operative Group Ltd (the opponent) on 23 December 2019. The statement of grounds and particulars (SGP) was filed on 23 March 2020, and set out the grounds of lack of novelty, inventive step, utility, clear enough and complete enough disclosure (“sufficiency”), and support. A first request to amend the SGP was filed on 24 December 2020 to include the ground of lack of best method. The amendment was allowed on 20 January 2021.
A second request to amend the SGP was filed on 5 May 2022 to remove the grounds of novelty and best method, as well as to amend some particulars. Because of the relatively short time available before the hearing, the usual practice of seeking comments from the applicant could not be followed, and the matter was held over for consideration at the hearing.
Evidence in support (EIS) was completed on 23 June 2020. Evidence in answer was completed on 23 October 2020, and evidence in reply was completed on 24 December 2020. The evidence comprised the following material:
| Declarant, dated | Exhibits | |
| EIS | Stephen Richard Davis (Davis 1), 23 June 2020 | SRD-1 to SRD-9 |
| Colin Robert South (South 1), 22 June 2020 | CS-1 to CS-3 | |
| Colin Robert South (South 2), 22 June 2020 | CS-4 to CS-10 | |
| EIA | Tiffany Reiter (Reiter), 20 September 2020 | Exhibit A |
| Tonya Schoenfuss (Schoenfuss 1), 22 September 2020 | Exhibits A to J | |
| Tonya Schoenfuss (Schoenfuss 2), 21 September 2020 | none | |
| Donald McMahon (McMahon 1), 12 October 2020 | Exhibits A to D | |
| Donald McMahon (McMahon 2), 22 September 2020 | none | |
| EIR | Stephen Richard Davis (Davis 2), 21 December 2020 | SRD-10 |
| Colin Robert South (South 3), 21 December 2020 | CS-11 to CS-12 | |
| Matt Duncan Golding (Golding), 23 December 2020 | MDG-1 to MDG-2 | |
| Jeremy Paul Hill (Hill), 18 December 2020 | JH-1 to JH-2 |
Following a request from the applicant, the Commissioner directed that the following paragraphs are not strictly evidence in reply and do not form part of the evidence in the opposition:
(a)Hill, paragraphs 2.1(i), 2.7-2.12 and 2.19-2.22, and exhibit JH-2
(b)Golding, paragraphs 3.1-3.4, 6.2, 6.6-6.7, 6.12-6.13 and 6.16-6.17.
(c)South 3, the last sentence of 2.16 and the last sentence of 4.4.
On 17 June 2021, the applicant filed a request under Regulation 5.23(1) that the Commissioner consider the following documents:
| Declarant | Exhibits |
| Tonya Schoenfuss (Schoenfuss 3), 14 June 2021 | TS-1 to TS-4 |
| Ravi Jhala (Jhala), 17 June 2021 (Corrected version filed on 18 June 2021) | RJ-1 |
The delegate advised the parties that they considered it appropriate to have regard to the documents, with the exception of paragraphs [6]-[14] and [29]-[33] of Schoenfuss 3. Comments were sought from the parties, and on 27 September 2021, the delegate advised the parties that they maintained this view. The opponent indicated that they wished to be heard on the matter. The parties were advised that this would be held over to the substantive hearing. On 8 December 2021 the opponent filed evidence in response under Reg 5.23 (2).
| Declarant | Exhibits |
| John Anthony Lucey (Lucey), 7 December 2021 | JAL-1 to JAL-18 |
| Colin Robert South (South 4), 7 December 2021 | CSR3-1 |
The matter was set for hearing for 19 May 2022. The opponent pressed the grounds of inventive step, utility, sufficiency and support at hearing.
The substantive amendments to the Patents Act 1990 (Cth) (the Act) brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) (the Raising the Bar Act) apply to the present case. The standard of proof in opposition proceedings is the balance of probabilities. If the Commissioner is satisfied, on the balance of probabilities, that a ground of opposition to the grant of the standard patent exists, the Commissioner may refuse the application. The opponent bears the onus of proof.
The principles of construction
10. I note the guidance of Middleton J in Eli Lilly and Company Limited v Apotex Pty Ltd:
“It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date.”[1]
[1] [2013] FCA 214; 100 IPR 451 at 139.
The person skilled in the art
11. The task of construing the specification is undertaken from the viewpoint of a person skilled in the art and the prevailing common general knowledge at the priority date. The person skilled in the art is a hypothetical non-inventive person or team likely to have a practical interest in the subject matter of the invention:[2]
“He is the person to whom the patent is addressed and who must construe it. He is the person whose knowledge will determine whether a patent is novel. He is the person who will judge whether a patent is obvious.”[3]
[2] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70]-[72].
[3] Ibid at [70].
12. The opponent submitted that the skilled person is a team of a dairy scientist and someone who understands the genetics of dairy proteins and the techniques for making recombinant proteins.[4] They acknowledged that all of the experts including the applicant’s experts, had relevant experience that fell within the hypothetical team’s skill set, but submitted that their evidence should be given limited weight for other reasons.[5] At the hearing they also submitted that Mr Jhala’s evidence of common general knowledge should be given lesser weight because he had worked for several years in the area directly related to the invention and therefore his experience was not a true reflection of the ordinary worker in that field.
[4] Opponent’s submissions (OS) at [43].
[5] OS at [44] and [14].
13. The applicant described the person skilled in the art as a team consisting of a dairy food scientist, and in particular a food technologist, with the knowledge and skills relevant to making dairy substitute food compositions, and a microbiologist, specifically with knowledge and skills relevant to microbial production of recombinant dairy proteins in fungal systems. On the basis of this description, they did not dispute that each of the opponent’s witnesses has knowledge of matters relevant to dairy science. However, they argued that they are not reflective of the state of knowledge of the person skilled in the art since none of them were microbiologists with experience in making recombinant dairy proteins, nor a food technologist. In the case of Dr Golding, the applicant submitted that while he is a food technologist his knowledge in relation to colloids goes well beyond the knowledge of the ordinary person skilled in the art.[6]
[6] AS at [76].
14. Given the nature of the invention disclosed, I consider the skilled person to comprise a team of food technologists together with a microbiologist with knowledge and skills in the preparation of recombinant proteins. I consider the team will have knowledge of milk proteins and skills in the preparation of dairy products and dairy substitutes. However, contrary to the applicant’s submissions, I do not consider the skilled person is limited to having direct experience in the use of fungal recombinant systems for the preparation of milk proteins since this would, in effect, constrain the skilled person to the specific solution provided by the specification.
15. Given this assessment, the expert witnesses all have knowledge and experience relevant to the team. The applicant submitted that Mr Jhala’s evidence is substantially factual evidence directed to the production of products made with a-lactalbumin and b-lactoglobulin as the sole milk proteins,[7] but I note that some of his evidence includes background technical information and for that reason I include him in the present consideration. In the case of Dr Golding, I do not consider it necessary to exclude his evidence on the basis of his background. Like all of the witnesses, he has a high level of knowledge and expertise. However, this in itself does not exclude his evidence (or indeed the evidence of any other expert), but rather is a factor in the weight that the evidence is given. To this end a key consideration will be whether the evidence is from the perspective of a hypothetical skilled person, rather than the expert themselves. I have not included Ms Reiter here since she only provided information related to the prosecution of the corresponding US patent application.
[7] AS at [70].
16. In addition to the suitability of the experts to provide evidence on technical matters, both parties questioned the independence of witnesses. The applicant noted that Drs Hill, South, Davis, and Golding are either currently employed, have been previously employed by the opponent or have received funding from the opponent. The opponent noted that Ms Reiter is a US patent agent who represents the applicant on the prosecution of the present application, and Mr Jhala is an employee of the applicant. I agree that the identity of the expert witness and their independence may be a relevant consideration when assessing the weight that can be given to their evidence, but these are not the only considerations in that assessment. Other considerations may include the nature and relevance of their experience and evidence, and as discussed above, whether the evidence is provided from the point of view of the person skilled in the particular art. Taking these broader considerations into account, I do not consider the issues identified by the parties justifies the exclusion of evidence from any of the witnesses, even though it may necessitate a detailed consideration as to the weight it can be given under all the circumstances.
The specification[8]
[8] Specification and claims as accepted.
17. At hearing the opponent highlighted that the focus of the specification is on compositions comprising casein proteins, while the claims are limited to the use of a-lactalbumin and b-lactoglobulin in compositions in which no other milk protein (including casein) is present. This is a significant issue in the determination, and I therefore consider the description in greater detail under the grounds of utility, support and sufficiency below.
18. The field of the invention is said to relate to dairy substitutes, methods of manufacturing the same, compositions comprising animal-free milk fats and proteins for food applications such as milk, butter, cheese, yoghurt, and cream.[9]
[9] Specification at page 1, lines 11 to 13.
19. The background of the invention estimates the global dairy market to be about $500b, with bovine milk attributing a significant portion of the market. Plant-based alternatives account for about $1b in the US, with lactose-intolerant milk accounting for about $700m. Bovine milk is known to have four specific caseins, a-s1-casein, a-s2-casein, b-casein, and k-casein. Mammalian milk comprises several thousand components, including water, lipids, sugars, proteins, and inorganic salts and other compounds.
20. The specification goes on to say that various alternatives, such as plant- or nut-based milks have been pursued for reasons relating to allergenicity, lactose intolerance, personal preference or perceived environmental benefits.[10] However, existing dairy milk alternatives are said to fall short both in flavour and functionality. A large part of the industrial and cultural significance of dairy milk stems from its usefulness in derivative products such as cheese, yoghurt, cream or butter. Non-dairy plant-based milks are said to almost universally fail to form such derivative products when subjected to the same processes used for dairy milk.[11] The specification goes on to say that there is a need for a dairy substitute or composition that has desirable flavour and performance characteristics, 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.[12]
[10] Specification at page 1, lines 16 to 31.
[11] Specification at page 2, lines 13 to 19.
[12] Specification at page 2, lines 28 to 30.
21. Under the “Summary of the Invention”, the present invention is said to be 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.[13] The “Detailed description of the Invention” commences with a similar statement, and states that in view of this discovery compositions, methods of making the compositions, kits including these compositions and mixtures for making these compositions are provided. The specification continues:
“The compositions provided herein provide for compositions that have a similar taste, mouth feel, aroma, and nutritional value as compared to a mammal-based 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). The compositions provided herein also have an improved shelf-life as compared to mammal-produced milk, and can have an improved aroma profile as compared to a mammal-produced milk.”[14]
[13] Specification at page 2, lines 28 to 31.
[14] Specification at page 29, lines 23 to 30.
22. The specification comprises 30 claims which are given in full in the attached Annex. Claim 1 is the only independent claim. This claim mirrors a “consistory clause”[15] that was incorporated in the summary of the invention with the amendments filed on 21 August 2019 in response to the first examination report:
[15] Specification at page 16, line 25 to page 16a, line 6.
1. A food composition comprising
(i)a recombinant b-lactoglobulin and a recombinant a-lactalbumin, wherein one or both of the recombinant b-lactoglobulin protein and the recombinant a-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).
23. The specification describes various specific compositions and kits, methods of making recombinant proteins, methods of making micelles, and methods of making various compositions. The examples include methods of making recombinant proteins as well as milk and cream formulations. These formulations all comprise casein proteins. This is discussed in greater detail below.
24. I note that the claim defines that “one or both” of the defined proteins comprises a sequence that is at least 90% identical to the bovine protein sequence and has been produced by a fungal cell. I understand this to mean that only one of the recombinant b-lactoglobulin and a-lactalbumin proteins needs to meet both of these two requirements. At the hearing the applicant submitted that where only one of the proteins met these two requirements, the composition of the second protein is determined by the general definition of “milk protein”, being at least 80% identical to the sequence of a protein that is found in mammal-produced milk.[16] I consider this a reasonable interpretation.
[16] Specification at page 18, lines 11 to 17.
25. At first blush, the claim appears to define a food product that comprises the specific composition of the two recombinant milk proteins, sweetening agents, ash and lipids per se. However, the food product is further characterised in that it has certain characteristics of a dairy food product. A key issue is the extent to which this limits the scope of the claims.
26. Neither of the terms “food composition” and “dairy food product” is defined in the specification, and the properties of the compositions defined by the claims was a point of some difference between the parties. The gist of the opponent’s arguments was that the term “food composition” requires certain properties, most notably palatability, to be achieved. They argued that absent this limitation, the claims are so broad that they would include virtually any composition that includes the listed components, whether or not the characteristics make it a food composition.[17]
[17] OS at [69].
27. The applicant acknowledged that the term “food composition” is not defined in the specification and submitted that it should therefore be given its ordinary meaning – that is, a substance that is eaten or taken into the body for nourishment.[18] They also submitted that the food compositions defined by the claims have a range of acceptable properties that make them suitable to be substituted for a dairy food product, but they need not be identical in all respects to any particular dairy food product.[19] They argued that it was clear from the language of Claim 1 and the description that the invention is related to dairy substitutes,[20] and that “properly construed and in line with the principle of purposive construction, the food composition of claim 1 is a dairy substitute food composition with the characteristics of a dairy food that is suitable to be substituted for a dairy food product.”[21]
[18] AS at [87].
[19] AS at [89].
[20] AS at [88].
[21] Ibid.
28. Claim 1 certainly does not appear to require that the food product is the same as, or even similar to, a “traditional” mammalian-based dairy food product. This is apparent from the definition of the food product having as few as one of the defined characteristics of a dairy food product. Moreover, there is no explicit requirement that the composition possess any particular level of palatability. No evidence appears to have been provided on the meaning of the term, but my understanding is that palatability is a subjective assessment of the personal preference for a food (that is, the extent to which a consumer finds the food agreeable). Some of the characteristics defined in the claim might contribute the palatability of a food product (taste, aroma, mouthfeel etc.), but there are other functional properties that do not appear to contribute to the palatability of a food product (elasticity, springiness and leavening). Given the food product can possesses as few as one of the defined characteristics it does not appear that the claim necessarily requires that the food product is palatable, provided it possesses at least one other of the defined properties of a dairy food product.
29. Nevertheless, the claim does define a food composition, and I understand this to require that it in some way is suitable for that purpose. I therefore accept the applicant’s submission that the term should be given its ordinary meaning. The subsequent consideration is whether the definition of the composition possessing one or more characteristics of a dairy food product limits the scope of the claim to a “dairy substitute food composition” as submitted by the applicant.
30. In this regard the applicant has argued that a purposive approach to construction should be taken. The basic approach to a purposive construction was considered by the Full Court of the Federal court in Artcraft Urban Group Pty Ltd v Streetworx Pty Ltd.[22] The Court cited with approval the approach set out in Kirin Amgen Inc v Hoechst Marion Roussel Ltd:
“Construction, whether of a patent or any other document, is of course not directly concerned with what the author meant to say. There is no window into the mind of the patentee or the author of any other document. Construction is objective in the sense that it is concerned with what a reasonable person to whom the utterance was addressed would have understood the author to be using the words to mean. Notice, however, that it is not, as is sometimes said, “the meaning of the words the author used”, but rather what the notional addressee would have understood the author to mean by using those words. The meaning of words is a matter of convention, governed by rules, which can be found in dictionaries and grammars. What the author would have been understood to mean by using those words is not simply a matter of rules. It is highly sensitive to the context of, and background to, the particular utterance. It depends not only upon the words the author has chosen but also upon the identity of the audience he is taken to have been addressing and the knowledge and assumptions which one attributes to that audience.”[23]
[22] [2016] FCAFC 29 at [79].
[23] [2004] UKHL 46; [2005] RPC 169.
31. As indicated above, a purposive approach is made through the eyes of the person skilled in the art, in this case the team of food technologists and microbiologists I identified above. While I am not required to take evidence on matters of construction,[24] I consider there is some value in considering the evidence on this point.
[24] Sequenom Inc. v Ariosa Diagnostics, Inc. [2019] FCA 1011 at [1250].
32. Here the invention is said to be based on the discovery that only a subset of components in mammal-produced milk can be used to generate a composition that has similar flavour, appearance, nutritional value, aroma and mouth feel of mammal produced milk.[25] However, the claim characterises the food composition in terms of the properties of a dairy food product, which I consider results in the claim taking on a different meaning and including dairy food products other than just milk.
[25] Specification at page 29, lines 17 to 22.
33. Dr Davis stated that he understood that the food compositions described in the specification are intended to be substitutes for compositions made with mammalian milk/milk products, and it is intended that the substitute compositions will taste and smell like a natural dairy product and will have similar nutritional and functional properties.[26] He subsequently referred to them as dairy food substitutes.[27] Dr Davis considered that the term “characteristics of a dairy product” is not clear in what it encompasses since, for example, the dairy products yoghurt, cheese, milk and whey protein all have different tastes, aromas, and functional properties. He went on to state that there is no definitive set of characteristics common to all dairy products, but that “the skilled worker could say what the typical ‘characteristics’ of a particular dairy product are if given parameters (e.g., taste)”.[28] I understand Dr Davis’ concerns on this point to relate to the use of the indefinite article in the claim, so that a composition having the properties of a dairy product would be assessed against all dairy products as opposed to the comparison being with the corresponding dairy product (for example, a like for like comparison of, say, a yoghurt with a yoghurt substitute). I consider that a common-sense interpretation would dictate that this comparison would be made on a like-for-like basis.
[26] Davis 1 at [3.8].
[27] Davis 2 at [2.2].
[28] Davis 1 at [4.12].
34. Dr Schoenfuss stated that the claims are not directed to a dairy food, but to a food composition having one or more defined characteristics of a dairy food. She stated that there are no standards for substitute dairy foods, and the only defining feature of a substitute dairy foods is its acceptance by consumers. This is typically determined by conducting tastings by consumer panels.[29] She also stated that there are a number of substitute dairy products on the market, including plant-based milks, cheese and yoghurt and their characteristics were well known as of the date of filing of the application.[30]
[29] Schoenfuss 1 at [7.8b].
[30] Schoenfuss 1 at [4.11].
35. On balance I consider it a reasonable construction that the claim is directed to compositions that are substitute dairy foods inasmuch as they possess characteristics of a dairy food product. I understand compositions containing the recombinant milk proteins are able to be processed using traditional methods to obtain properties in down-stream products that are usually provided by the wild-type proteins in mammalian milks.[31] This is consistent with the disclosure in the specification that the methods and compositions of the invention can be used to provide a wide variety of dairy substitute products. These include milk, whole milk, buttermilk, skim milk, infant formula, condensed milk, dried milk, evaporated milk, butter, clarified butter, cream, and various types of cheese,[32] as well as methods of making butter, cheese, caseinate and yoghurt using the compositions of the invention as a starting material.[33] Given that the claims require as little as a single property in common with the corresponding dairy food product, the resulting dairy substitute product may be a poor substitute, but it is a substitute nonetheless.
[31] Specification at page 2, lines 20 to 25.
[32] Specification at page 78, lines 18 to 21.
[33] Specification at page 75, line 27 to page 76, line 6.
36. However, I do not consider that the definition of the food composition extends to all food products comprising the defined combination of recombinant proteins, sweetening agents, ash and lipids. The specification appears to distinguish between dairy substitute products and other “food applications” in which the compositions of the invention replace dairy products. These include ice cream, frozen custard, frozen yoghurt, cookies, cakes, cottage cheese, cream cheese, crème fraiche, curds and yoghurt.[34] I understand these “applications” to involve the use of milk proteins to supplement another product, including where a “normal” dairy product is supplemented using the recombinant proteins of the invention. The resulting products in such cases would of course be excluded from the claim as a result of the limitation that the food product does not contain any milk proteins other than the two defined recombinant proteins. But it also follows from my interpretation above that the claim does not extend to food products that do not retain the properties of a dairy food product, or that would not be considered a substitute dairy product, such as cakes, cookies and other food compositions in which milk proteins are added as a supplement.
[34] Specification at page 78, lines 22 to 25.
37. I will note here that I have significant concerns with the manner in which the invention is characterised in terms of properties of a dairy food product. The applicant submitted that, following a purposive construction, a food composition having only one of the characteristics of a dairy product that is not an acceptable dairy substitute food composition would not fall within the scope of the claim. I consider this raises issues about the clarity of the claims and whether a skilled person could determine whether they are performing an act that would constitute an infringement of the claim of Claim 1. Moreover, given the evidence of Dr Schoenfuss mentioned above, this determination appears to require a subjective measure of consumer acceptance by tasting panels. I consider this would impose an undue burden of experimentation on the part of the addressee to work the invention across the full scope of the claim (and indeed to determine if they are working within the scope of the claim). However, clarity was not a ground of opposition raised by the opponent, and the opponent’s submissions on sufficiency and support were ultimately successful for other reasons, so my concerns in this regard are probably moot.
38. In summary, for the present determination I consider that Claim 1 can be construed as defining dairy substitute products that possess one or more characteristic properties of a corresponding dairy product. This includes substitutes of dairy products such as milk, cheese, whey and yoghurt, but does not extend to other food products that do not retain the properties of a dairy product or that are food applications that would not ordinarily be considered a dairy product (such as some types of downstream products incorporating the compositions defined in Claim 1). All of the claims are dependent on Claim 1, so this interpretation flows through to the construction given to them. There are no other significant construction issues in the remaining claims that require detailed consideration here.
The Request under Regulation 5.23.
39. Reg 5.23 states that
(1) For the purposes of deciding an opposition, the Commissioner may consult a document that:
(a) is relevant to the opposition; and
(b) has not been filed under this Chapter; and
(c) is available in the Patent Office
40. The overarching principle for whether documents should be allowed under Reg 5.23(1) was given in Merial v Bayer Intellectual Property GmbH (Merial v Bayer) as follows:[35]
“… a decision under regulation 5.23 must have regard to the nature of the information and whether the information is likely, if not certain, to change the outcome of the opposition in a significant way.”
[35] Merial v Bayer, [2015] APO 16 at [24].
41. The applicant’s request of the 17th and 18th June 2021 for the Commissioner to consider the documents Jhala and Schoenfuss 3 was made on the basis that this evidence was directly relevant to the key issues in dispute, and that it addressed points articulated by the opponent for the first time in its evidence in reply. They argued that the opponent’s case had shifted, with the grounds of support and sufficiency being expanded, and novelty and best method abandoned. This evidence the subject of the reg 5.23 request included:
· evidence that dairy substitute products comprising β-lactoglobulin and α-lactalbumin proteins, and no other diary proteins (including no casein), can in fact be made as claimed
· evidence that such products can be (and were) made (without casein) using routine methods based on the teaching provided in the specification and the skilled person's common general knowledge and with no “special or unusual steps”
· evidence that such products comprising β-lactoglobulin and α-lactalbumin proteins as the sole dairy proteins have appropriate properties
· evidence as to how the claims are supported by the specification as originally filed, including disclosures in the originally filed specification relating to the use of subsets of dairy proteins (including only β-lactoglobulin and α-lactalbumin proteins) to prepare dairy substitute products
· evidence that fungal-derived proteins have attributes that contribute to properties (e.g., gelation) of the dairy substitute products.
42. On 27 September 2021 the delegate advised the parties that they considered it appropriate to consult the Jhala and Schoenfuss 3 declarations, with the exception of Schoenfuss 3 at [6]-[14] and [29]-[33] and exhibits referenced therein. The parties were given the opportunity to comment on the proposed direction to exclude this material. Despite the submissions from both parties, the delegate maintained this position. On 7 October 2021 the opponent indicated that it wished to be heard regarding the request under Reg 5.23(1), as well as advising that they intended to file responding evidence. On 8 December 2021, the opponent filed the Lucey and South 4 declarations under Reg 5.23(2).
43. At hearing the opponent submitted that it would not press their objection to the documents filed under Reg 5.23 provided the responsive evidence (South 4 and Lucey) was admitted. The applicant reiterated the submissions made before the delegate and also provided a table of references in South 4 and Lucey that they considered were not responsive to the Jhala and Schoenfuss 3 declarations (AS at [51]).[36] The opponent provided verbal submissions at hearing on these points. I have taken all of this material into account in the present determination.
[36] Applicant submissions (AS) at [51].
44. In Reflex Instructions Asia Pacific Pty Ltd v Minnovare Limited,[37] in addition to the relevance and importance of the evidence, the delegate considered factors such as the circumstances leading up to the evidence not being filed earlier, the public interest and the balance of convenience of the parties if the information is considered. These factors were considered by the delegate in their preliminary views that:
· The evidence at Schoenfuss 3 [6]-[14] and [29]-[33] are unlikely to change the outcome of the opposition in a significant way.
· In relation to submissions from the opponent that Mr Jhala and Dr Schoenfuss were not independent witnesses, the delegate noted that the independence of an expert might impact on weight attributed to their evidence but found that it is not prima facie apparent that the evidence was of such low weight that it is incapable of changing the outcome of the opposition.
· The evidence given at Jhala [15]-[22] and Schoenfuss 3 at [18]-[28] is likely to be crucial to the determination in that it provides a basis for the proposition that non-milk dairy substitute products may be made without proteins (e.g. casein) additional to β-lactoglobulin and α-lactalbumin.
· The specification does not exemplify any products containing only β-lactoglobulin and α-lactalbumin as the only milk proteins. Dr Schoenfuss’ evidence at [34]-[46], [50] is complementary to the Jhala Declaration and provides evidence as to the common general knowledge and the content of the opposed application regarding the preparation of dairy substituted products. This evidence is significantly better than that already on file and likely to be crucial with respect to the sufficiency case.
[37] [2017] APO 8 at [52].
45. The delegate concluded that:
“I will say that it is not clear to me why much of this evidence was not or could not have been filed earlier (for example, there is no apparent reason why details regarding the preparation of dairy substitute products referred to in the evidence in answer were not described). However, I am inclined to a consider, based on observations made by the Opponent with respect to the evidence in reply, the Applicant’s submissions, and item 5.4 of the statement of grounds and particulars, that the capacity to produce substitute dairy products within the scope of the claims, and the resulting characteristics thereof, is a matter likely to be of significance in the opposition. The evidence now filed is, in my view, significantly better than that already on file with respect to this point. On balance, my preliminary view is that it is appropriate to consult the Jhala Declaration and accompanying exhibits and the Third Schoenfuss Declaration and accompanying exhibits (excluding [6]-[14] and [29]-[33] and exhibits referenced therein) under regulation 5.23.”
46. After the hearing, on 7 June 2022, I wrote to the parties to advise them that I agreed with the delegate’s view that Jhala and Schoenfuss 3 should be considered in the opposition. I also agreed that the evidence in Schoenfuss 3 at [6]-[14] and [29]-[33] should be excluded. Schoenfuss 3 at [6]-[14] merely describes the information given at various parts of the specification and gives no further explanation or information beyond that which would be self-evident on the face of the specification. In the case of the evidence in Schoenfuss 3 at [29]-[33], the evidence is apparently intended to assist with the understanding of the scope of the claims and in particular the extent to which a product must possess the characteristics of a dairy product. This determination appears to be made from the viewpoint of the intended market for the products (vegans) and their environmental concerns, rather than from the point of view of the person skilled in the art and the meaning they would attribute to the terminology used. I agreed with the delegate that this evidence is of little value in the opposition.
47. One of the key issues in the hearing was whether the specification provided a clear enough and complete enough disclosure. A significant consideration in this regard is whether the specification, read in light of the common general knowledge, enables the skilled person to perform the invention over the whole width of the claims without undue burden or the need for further invention. A prima facie consideration of the evidence suggested it could be crucial in making this assessment, including the extent to which the steps to make a food product falling within the scope are disclosed in the specification or would constitute an undue burden over such disclosure.
48. Where the Commissioner proposes to rely on a document filed under Reg 5.23(1), the parties must be given the opportunity to give evidence or make representations about the document. In this regard the opponent has provided evidence in the form of declarations and accompanying exhibits (Lucey and South 4), and both parties had the opportunity to make representations about the documents at the hearing. Therefore, this requirement of the regulations has also been addressed.
49. The remaining issue is the extent to which Lucey and South 4 are responsive to Jhala and Schoenfuss 3. The submissions from the applicant provided a paragraph-by-paragraph comparison of Jhala and Schoenfuss 3 with the responding evidence. While there may be instances where the responding evidence is not specific to the point raised in a particular paragraph, I consider the evidence to be broadly responsive to the evidence provided in Jhala and Schoenfuss 3 and in particular to the points raised by the applicant in their request. However, I agree with the applicant that South 4, paragraphs 2.11 and 2.12 are not in response to Jhala because this extrinsic material does not relate to the issues raised by Mr Jhala or to any of the issues at the core of the material provided under Reg 5.23 (a record of the USPTO examination prosecution, and discussion of a citation raised during prosecution of the Australian patent application). I do not consider that this evidence is crucial to the grounds being considered in the opposition.
50. I therefore will have regard to the following material in my determination pursuant to regulation 5.23:
The Jhala and Schoenfuss 3 declarations, with the exception of Schoenfuss 3 at [6]-[14] and [29]-[33] and exhibits referenced therein.
The Lucey declaration and the South 4 declaration, with the exception of paragraphs 2.11 and 2.12 and exhibits referenced therein.
51. The Lucey and South 4 declarations having been filed as responsive evidence under regulation 5.23(2), I advised the parties with my letter of 7 June 2022 that there was no requirement for any further evidence from the parties. Furthermore, there are no outstanding issues in relation to the request for amendment of the SGP filed on 5 May 2022 and I allow that amendment.
Inventive Step
52. Section 7(2) of the Act sets out that an invention is taken to involve an inventive step unless it would have been obvious to the person skilled in the art in the light of the common general knowledge, either considered alone or together with information of the kind set out in section 7(3) of the Act.
53. In Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd (Wellcome), Aickin J formulated the test for whether an invention is obvious as whether it would have been a matter of routine to proceed to the claimed invention.[38] In Aktiebolaget Hassle v Alphapharm Pty Ltd (Alphapharm),[39] the High Court accepted the approach taken by Graham J in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd (Olin Mathieson), where he posed the reformulated Cripps question:
“Would the notional research group at the relevant date, in all the circumstances, ... directly be led as a matter of course to try [the claimed combination] in the expectation that it might well produce a [useful or better result]?”[40]
[38] [1981] HCA 12; 148 CLR 262 at 286 (Wellcome).
[39] [2002] HCA 59 at [53]; (2002) 212 CLR 411 at [53].
[40] Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157 at [187].
54. The approaches taken in Wellcome and in Olin Mathieson are not at odds, and indeed the High Court in Alphapharm considered the two approaches have an affinity.[41] The similarity of the approaches was recognised by the Full Court in Generic Health Pty Ltd v Bayer Pharma AG:
“We do not think that the plurality in Alphapharm were saying that the reformulated Cripps question was the test to be applied in every case. Rather, it is a formulation of the test which will be of assistance in cases, particularly those of a similar nature to Alphapharm. The plurality did not reject as an alternative expression of the test the question whether experiments were of a routine character to be tried as a matter of course… We do not think there is a divide here in terms of whether an expectation of success is relevant between a test which refers to routine steps to be tried as a matter of course and the reformulated Cripps question. It is difficult to think of a case where an expectation that an experiment might well succeed is not implicit in the characterisation of steps as routine and to be tried as a matter of course. On the other hand, we think a test formulated in terms of worthwhile to try was firmly rejected by the High Court in Alphapharm…”[42]
[41] Aktiebolaget Hassle v Alphapharm Pty Ltd supra at [53].
[42] (2014) 222 FCR 336 at [71].
55. Following this guidance the opponent submitted that the often-asked Cripps question is not always appropriate, particularly where more than one thing might be obvious, and that in such cases the question of whether experiments were of a routine character to be tried as a matter of course remains relevant.[43] They made submissions in relation to a lack of inventive step on the basis of common general knowledge alone, as well as lack of inventive step based on the common general knowledge considered together with the information provided by the following two documents:
D1 US 8809259
D2 WO 1995/002692
[43] OS at [127]-[129] and references cited therein.
56. The opponent’s submissions took two separate lines of reasoning – obviousness where the claim construction requires that the compositions are palatable, and obviousness where the claimed compositions are not required to be palatable. Given my interpretation of the claims and my conclusion that the claims do not necessarily require that the composition be palatable, I will concentrate on the latter, but I consider that this distinction would ultimately make no difference to the outcome.
57. The applicant suggested the use of a problem-solution approach and identified the problem to be solved as being to make a dairy substitute food composition using non-dairy components that has a desirable flavour and performance characteristics. As noted above, the opponent did not propose a problem-solution approach, so therefore did not identify a problem to be solved.
58. The problem suggested by the applicant appears to differ in several respects to the one suggested by the specification. In particular, the specification indicates that existing dairy milk alternatives such as soy, almond and coconut milk, can alleviate concerns with environmental impact of dairy farming and foodborne pathogens, but fall short both in flavour and in functionality. The specification also indicates that a large part of the industrial and cultural significance of dairy milk stems from its usefulness in derivative products such as cheese, yoghurt, cream and butter. However, such non-dairy plant-based milks “almost universally” fail to form such derivative products when subjected to the same processes used for dairy milk.[44] The specification then states that:
“What is needed, therefore, is a dairy substitute or composition that has desirable flavor and performance characteristics, e.g., a composition that replicates dairy flavors minimizes 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.”[45]
[44] Specification at page 2, lines 13 to 19.
[45] Specification at page 2, lines 20 to 25.
59. Thus, the problem set out in the specification appears to include that the milk substitute is capable of being processed in a manner similar to dairy milk to provide derivative products. This is not necessarily the same as simply providing a dairy food substitute. Moreover, the problem the applicant has proposed includes the aim of providing a dairy food substitute with desirable flavour and performance characteristics, while the claim as defined requires only one or more of a particular range of taste and functional characteristics. Taking these factors into account I do not agree with the problem proposed by the applicant. Under the circumstances I do not consider it necessary to identify an alternative problem, but instead will adopt the approach suggested by the opponent in asking whether it would be routine for the skilled person to arrive at the claimed compositions for use as dairy food substitutes as a matter of course.
60. The gist of the opponent’s submissions was that it would be obvious, in view of the common general knowledge alone, to use recombinant β-lactoglobulin and α-lactalbumin to create whey food compositions, such as ricotta or mozzarella, or powdered compositions. They also submitted that it would be possible to make low quality dairy substitutes with these ingredients. Their second line of argument was that the claimed invention is obvious in view of each of D1 and D2 in view of the common general knowledge. I will deal with each of these in turn.
Obviousness in view of the common general knowledge alone
61. β-Lactoglobulin and α-lactalbumin, together with other proteins including lactoferrin, transferrin and serum albumin, are found in whey which is the liquid remaining after milk has been curdled and strained. β-Lactoglobulin is the major whey protein of cow and sheep’s milk but is not found in human, rodent, rabbit or camel milk.[46] Whey, whey protein isolate and whey protein concentrate have been used as food ingredients.[47] It was not disputed that β-lactoglobulin has useful functional properties such as gelation and film forming,[48] though the applicant noted that it was not used alone or only with α-lactalbumin in food products for that purpose.[49]
[46] Davis 1 at [4.5].
[47] Schoenfuss 3 at [18].
[48] OS at [36].
[49] AS at [112].
62. The opponent submitted that it was known as of the priority date that it may be desirable to make recombinant dairy proteins. For example, lactoferrin had been produced by the genetic modification of rice, mice, cows, fungi and yeasts,[50] and Dr South had been involved in research into making recombinant β-lactoglobulin and α-lactalbumin in a fungal system.[51] I note that while information may be known, it must be established that the information has been widely accepted in the art in order for it to be considered common general knowledge. The evidence provided does not establish this to be the case and therefore I do not consider this information to be common general knowledge.
[50] OS at [35].
[51] South 1 at [7.7].
63. The applicant submitted that it was not common general knowledge to use isolated β-lactoglobulin and α-lactalbumin as ingredients to make dairy substitute food compositions.[52] This appears consistent with the opponent’s submission that as of August 2014, in order to come close to replicating the performance and flavour (and other sensory attributes) of typical dairy milk products, the composition of a dairy product would require the integration of specific components including casein proteins and minerals, and that whey compositions typically have an unpleasant taste and aroma and would not replicate a whole milk composition in terms of taste, aroma and functional properties.[53]
[52] AS at [113(b)].
[53] OS at [37] to [38].
64. Given that the use of recombinant β-lactoglobulin and α-lactalbumin as food ingredients, as well as the specific use of this combination as a whey substitute, was not common general knowledge, it follows that the claims are not obvious in view of the common general knowledge alone. That is, it would not have been a matter of routine for the skilled person in the art to prepare a dairy substitute product using this combination of recombinant proteins.
Common general knowledge combined with D1
65. D1 discloses nutritive compositions comprising recombinant proteins. The emphasis of this disclosure is on proteins having desirable solubilities and ratios of branched amino acid to total amino acids. The opponent referred to the evidence of Dr South, who stated that:
“the process for expressing recombinant proteins in a fungal cell was being use (sic) and was well understood in 2014. The whey proteins claimed and their sequences were well known. β-lactoglobulin and α-lactalbumin would have been obvious for the skilled person to select as target proteins for a food product. It would have been obvious for the skilled person to begin with a sequence as close as possible to the wild type protein. Allowing for up to 10% modification of the protein sequence theoretically permits changes to be made to improve (say) protein digestibility, and is facile from a technical perspective.”[54]
[54] South 2 at [5.2].
66. Dr South went on to state that since D1 discloses each of β-lactoglobulin and α-lactalbumin, sweetening agents, ash and lipids, which could be incorporated into a dairy food product it was obvious to make the invention claimed in Claim 1.[55]
[55] South 2 at [5.5].
67. On the other hand, Dr Schoenfuss noted that D1 discloses a large number of proteins (the applicant’s submissions suggest there is 70[56]), and went on to state that:
“D1 does not provide any guidance as to which of these proteins can be used to produce food compositions having characteristics of dairy foods… If a person in my field at the time of filing Perfect days patent application (August 21 2014) had been instructed to select from the list of proteins provided in D1 a protein or combination of proteins for the production of food compositions that have one or more characteristics of a dairy food product, it is my opinion… that the person skilled in the art would not have chosen the specific combination of beta-lactoglobulin and alpha-lactalbumin, but rather would have chosen other milk proteins, particularly the caseins.”
[56] AS at [141].
68. Dr McMahon similarly considered that caseins would have been selected if seeking to prepare a dairy food product in view of D1, reasoning that caseins are known to be the major structural components of dairy food products.
69. On balance I find the applicant’s submissions to be persuasive. D1 discloses a wide range of nutritive proteins, including β-lactoglobulin and α-lactalbumin, and while α-lactalbumin is mentioned, it is not specifically prepared. Recombinant β-lactoglobulin is prepared, but D1 does not specifically use a fungal expression system in the examples, even though there is a broad reference to such expression systems. There is no disclosure or suggestion of the use of the specific combination of β-lactoglobulin and α-lactalbumin, or the aim of obtaining the flavour or functional properties of a dairy food product. Given the number of differences between the prior art disclosure and the claimed invention, I do not consider that it would be obvious in view of D1, even combined with the common general knowledge in the art, to make a product comprising the specific combination defined by the present claims for use in a food product.
Common general knowledge combined with D2
70. The opponent submitted that D2 discloses α-lactalbumin protein having at least 90% homology with the reference protein, sweetening agents, ash and lipids where the composition does not contain any other milk proteins,[57] and discloses that the modified α-lactalbumin could be used, for example, in ice cream.[58] They also noted that D2 discloses the use of fungal expression system.[59] The opponent submitted that it would be obvious to combine α-lactalbumin with a second recombinant protein, β-lactoglobulin.
[57] South 2 at [5.10].
[58] South 2 at [5.11].
[59] South 2 at [5.10].
71. The applicant noted that the recombinant α-lactalbumin described in D2 has been modified to remove phenylalanine so that it may be consumed by patients suffering from phenylketonuria, and there was no disclosure of a food composition comprising recombinant β-lactoglobulin and α-lactalbumin.[60] They submitted that neither Dr Schoenfuss nor Dr McMahon saw any motivation in D2 to combine β-lactoglobulin and α-lactalbumin as the sole milk proteins, and to the contrary as β-lactoglobulin contains four phenylalanine residues, there is a motivation not to include it with α-lactalbumin that has been modified to exclude phenylalanine as it would defeat the purpose of excluding phenylalanine.[61] Furthermore, the only mention of β-lactoglobulin in D2 is that it is thought to be a potent antigen in susceptible humans, which the opponent argued does not rise to the level of a clear suggestion or motivation to add it.[62]
[60] Schoenfuss 1 at [3.5].
[61] Schoenfuss 1 at [3.5], McMahon 1 at [3.5].
[62] AS at [145].
72. I find these submissions persuasive. The skilled person would not be led to the claimed combination of β-lactoglobulin and α-lactalbumin in view of D2, and to the contrary, the phenylalanine content of β-lactoglobulin would act as a disincentive to combine it with the protein disclosed in D2. The claims therefore are inventive in view of D2.
73. In summary, all claims are inventive in view of the common general knowledge alone, or D1 or D2 combined with the common general knowledge.
Support
74. Section 40(3) of the Act requires that the claims must be supported by matter disclosed in the specification. At the heart of this consideration is the principle that the “extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported, or justified.”[63]
[63] EXXON/Fuel Oils (T409/91) [1994] OJ EPO 653.
75. In CSR Building Products Limited v United States Gypsum Company (CSR),[64] the delegate took the following approach to determine whether the claimed matter is supported by the matter disclosed in the specification:
(a)Construe the claims to determine the scope of the invention claimed.
(b)Construe the description and the technical contribution to the art, that is how far the concept has carried forward the state of the art.
(c)Decide whether the claims are supported by the technical contribution to the art.
[64] [2015] APO 72 at [115].
76. The Federal Court has approved of this approach.[65]
What does the specification disclose?
[65] Cytec Industries Inc v Nalco Company (2021) 162 IPR 202.
77. Aldous J in Schering Biotech Corp’s Application (Schering) stated that:
“[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.”[66]
[66] [1993] RPC 249 at [252].
78. This guidance is particularly relevant to the present case. The opponent noted that present claim 1 and a corresponding consistory clause at page 16 to 16a were only incorporated during the examination of the application.[67] They argued that there was no guidance in the specification for the preparation of the invention defined by Claim 1, including from this consistory statement.[68] At the hearing the applicant noted that the consideration of whether the claims are supported is based on the application as accepted, so the consistory statements are to be taken into account when determining whether the claims are supported.
[67] OS at [84].
[68] Citing South 3 at [3.9].
79. I agree with the applicant on this point, but following the above guidance provided in Schering, I do not consider that a claim will meet the support requirement simply by the inclusion of a corresponding consistory clause. Support requires more than “mere mention” of features. In Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd (Jusand),[69] Rofe J had regard to the principles set out by the UK Supreme Court decision in Regeneron,[70] which stated that in the case of a product claim, the contribution to the art is the ability of the skilled person to make the product itself, rather than (if different) the invention. Rofe J continued:
“Lord Justice Briggs expanded upon the second point at [58]. In the case of a product, the contribution to the art is the product which is enabled to be made by the disclosure. Sufficiency requires substantially the whole range of products within the scope of the claim to be enabled to be made by means of the disclosure in the patent, and this both reflects and applies the principle that the contribution to the art is to be measured by the products which can thereby be made as at the priority date, not by the contribution which the invention may make to the value and utility of the products, the ability to make which, if at all, lies in the future.
Enablement across the scope of a product claim is not established merely by showing that all products within the relevant range will, if and when they can be made, no matter how much ingenuity is required, deliver the same general benefit intended to be generated by the invention.”[71]
[69] [2022] FCA 540.
[70] Regeneron Pharmaceuticals Inc v Kymab Ltd[2020] UKSC 27.
[71] Jusand, supra at [503]-[504].
80. As noted in Jusand, a key consideration in the case of a product is what the specification enabled, at the priority date, to be made. In the present case the opponent submitted that, on a fair reading, the application does not suggest that it is possible to make a food composition comprising β-lactoglobulin and α-lactalbumin and no other milk protein where the composition has one or more of the qualities of dairy products. They argued that the teaching in the specification is directed to compositions containing casein, and highlights the importance of micelles, which the application does not show can be produced using β-lactoglobulin and α-lactalbumin. Because the applicant has not enabled the invention across the full scope of the claims, they do not reflect the technical contribution of the application.[72] The fact that the applicant has subsequently managed to produce products that fall within this description does not affect this conclusion. Dr South and Dr Lucey stated that each of the products described in the Jhala declaration uses a product designated as “PD cream” as a base, but there is no discussion of the use of a base product in the application, and the examples neither use nor result in a product like the PD cream.[73]
[72] OS at [81] to [88].
[73] OS at [85].
81. The applicant acknowledged that the embodiments disclosed in the specification comprise casein but argued that the embodiments were not limited to these.[74] At hearing the applicant sought to distinguish the present case from Regeneron since that case depended on further and different inventions made some years after the priority date. They argued that this is not the case here because once the skilled person was in possession of the application, they would be able to make the invention across the scope of the claim because the claimed embodiment is not based on any further and different inventiveness.
[74] AS at [185].
82. As an initial point, I note that the applicant’s submissions are not simply that recombinant β-lactoglobulin and α-lactalbumin can be used as replacements for whey proteins in whey-based milk substitute products. Rather the specific recombinant proteins are substitutes for casein proteins, or put differently, the form of the invention defined by the claims, specifically lacks casein. They submitted that the technical contribution is premised on a surprising and previously unrecognised principle of general application, namely, that a subset of proteins of mammal produced milk expressed in fungal systems can be used to prepare a dairy substitute food composition.[75] They stated that the technical contribution includes a specific application of the general principle, namely that recombinant β-lactoglobulin and α-lactalbumin may be used as the sole milk proteins (therefore without casein) to make a dairy substitute composition when combined with ash, sweetening agents and lipids. At the hearing the applicant also suggested that the following boilerplate statement in the specification provided guidance to the skilled addressee to prepare food compositions according to the claims:
“As one of skill in the art can appreciate, the amount of each component used in these methods can be calculated in order to produce any of the compositions described herein.”
[75] AS at [192].
83. The applicant’s submissions arguably highlight the lack of any specific disclosure in the specification of compositions containing only recombinant β-lactoglobulin and α-lactalbumin as the only milk proteins. When determining whether a claim is supported, an important consideration will be whether the technical contribution is a general principle, or whether it is the specific examples in the specification.[76] A principle of general application simply refers to the situation where a claim, or an integer of a claim, is drafted in general terms because it is reasonable to expect the invention will work across the full scope of the invention claimed.[77] In most cases a number of embodiments will be provided from across the range of a general term in order to establish that there is a principle of general application, though in some cases a single example may be enough if that example can be considered representative of the entire group. Here the claims do not define the invention in terms of a principle of general application, but instead are very specific in relation to the milk proteins and other ingredients. However, the applicant has sought to establish support for the claims based on the broad reference to a subset of milk proteins together with various general references to β-lactoglobulin and α-lactalbumin throughout the description, rather than any specific embodiment(s) of such compositions.
[76] CSR at [113].
[77] Kirin-Amgen Inc. v Hoechst Marion Roussel Ltd supra note 23 at [112].
84. In this regard, the specification does not provide an explicit definition of the milk proteins that make up the “subset” of components that achieve the desired flavour and functional properties of the dairy food substitute. The applicant referred me to the following parts of the specification (emphasis provided by applicant) in support of their submissions:
“Disclosed herein are methods and compositions to produce dairy substitutes. In some embodiments, methods and compositions are provided for a dairy substitute food product comprising one or more isolated milk protein components, fats, carbohydrates and ash.”[78]
“The term ‘milk protein component’ refers 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 herein.”[79]
“Also provided herein are methods and compositions for dairy substitute food product comprising one or more isolated milk protein components, fats, carbohydrates and ash.”[80]
[78] Specification at page 15, lines 19-22.
[79] Specification at page 18, lines 7 to 10.
[80] Specification at page 30, lines 1 to 3.
85. The applicant also submitted that Examples 6 to 8 would teach the person skilled in the art to make a dairy substitute food product comprising recombinant β-lactoglobulin and α-lactalbumin proteins as the sole milk proteins using a fungal expression system.
86. I note the generality of the text highlighted by the applicant in the above references to isolated milk protein components and whey, rather than specifically to the combination of recombinant β-lactoglobulin and α-lactalbumin. I also note that the summary of the invention states that the invention is based on the discovery that only a “subset of components” in mammalian milk are required to provide a milk-like product. The term “components” in this context is broader in meaning than just the milk proteins and includes other non-protein components of mammalian milk such as ash, carbohydrates and the like.[81]
[81] Specification at page 19, lines 4 to 5.
87. Despite the applicant’s submissions, I agree with the opponent to the extent that the specification is directed to dairy substitute foods that comprise casein protein(s). Contrary to the applicant’s submissions, examples 6 to 8 do not teach the preparation of a dairy substitute composition comprising only recombinant β-lactoglobulin and α-lactalbumin proteins as the sole milk proteins. Example 6 describes the preparation of recombinant milk proteins, including β-lactoglobulin and α-lactalbumin proteins, which are said to be useful in the production of food products. However, the specific food compositions described in examples 7 and 8 include casein (and specifically micellar casein) and use whey protein rather than the specific combination of recombinant β-lactoglobulin and α-lactalbumin, together with other non-protein components.
88. Furthermore, examples 3 and 4 also describe the preparation of milk formulations, and example 4 is said to be a preliminary proof of concept. These examples describe the properties of milk formulations comprising various amounts of milk components (casein, whey, sugars and salts). Poor results, and particularly poor mouthfeel, are said to occur as a result of the presence of ash in the protein mixture and the separation of a significant proportion of whey (which the opponent submitted at hearing indicated that too much whey was undesirable),[82] lack of whey protein in mixtures comprising casein only,[83] and bad casein micelle formation in mixtures of whey and casein without any calcium ion.[84] There is nothing in these examples that would teach the use of whey protein (and more specifically the recombinant β-lactoglobulin and α-lactalbumin) without casein in milk formulations. To the contrary, Table 4 indicates that casein is required (1-10% w/v) but whey proteins are optional (0-1% w/v).
[82] Specification at page 93, lines 20 to 23.
[83] Specification at page 94, lines 16 to 17.
[84] Specification at page 95, lines 2 to 3.
89. Pages 3 to 15 of the specification set out an extensive number of compositions and methods provided by the invention, none of which specifically uses the combination of β-lactoglobulin and α-lactalbumin proteins. There is a specific reference to β-lactoglobulin and α-lactalbumin proteins at page 6, line 16, but this is to casein-containing compositions further including these proteins rather than them being the sole milk proteins. Besides the consistory clauses on pages 16 to 16a, the most specific disclosure of the combination of β-lactoglobulin and α-lactalbumin is perhaps provided in a general description of whey proteins, where the typical proteins in whey are discussed before stating:
“In one embodiment, a select combination of whey proteins comprising β-lactoglobulin and α-lactalbumin are used as the primary component or at least a part of the milk protein component or composition.”[85]
[85] Specification at page 37, lines 6 to 8.
90. While this passage highlights the use of a combination of β-lactoglobulin and α-lactalbumin, the combination is said to be the primary (or main) component or at least part of the milk protein component. I do not understand this to mean that the two proteins are the sole milk protein components in the final food products. To the contrary, I take the reference here to be in relation to the whey milk protein component used together with casein in the dairy food compositions.
91. In short, 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 β-lactoglobulin and α-lactalbumin, 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.
92. The applicant sought to rely on the evidence of Mr Jhala in support of their submissions that the skilled person in possession of the specification would be able to work the invention across the full scope of the claims. However, I do not consider that Mr Jhala’s evidence provides such support. In particular, Mr Jhala stated that he personally observed that fungal derived protein has comparable solubility, heat stability, gel water binding capacity and emulsification to that of WPI, but has enhanced clarity, and importantly has enhanced gel strength and foaming stability. As a result, casein is not required in the manufacturing process to make satisfactory substitute dairy products. He also observed that pure fungal derived β-lactoglobulin has a more neutral taste than WPI. On the basis of these differences and his own experience, he stated that it is possible to make substitute dairy products with α-lactalbumin and β-lactoglobulin as the sole milk proteins while still preserving important properties such as structure, texture, mouthfeel and aggregation properties traditionally attributed to casein. In particular, he stated that:
“I have been asked by Allens to comment on the proposition that casein is essential to achieving the characteristics of dairy food in products of the type referred to in this declaration. When using α-lactalbumin and β-lactoglobulin as the sole milk proteins, no special or unusual steps were required to replicate the characteristics usually contributed by casein in those products.”
93. I see no suggestion in the specification that α-lactalbumin and β-lactoglobulin 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.[86] Notably, Mr Jhala does not state that he gleaned the purported properties from the specification, but rather from his own observations and personal experience.
[86] Specification at page 37, lines 5 to 6.
94. I also do not consider the applicant’s submissions to be persuasive in regard to the claims being an embodiment of a principle of general application that a subset of milk proteins expressed in fungal systems can be used to prepare a dairy food product. Given my interpretation above, the specification does not describe a principle of general application that any combination of milk proteins can provide suitable dairy substitute food products, but rather a specific combination of milk proteins, including casein, as well as other dairy milk components, is required. The mere presence of a consistory clause that mirrors the language of Claim 1 does not address this deficiency. As noted in Regeneron the technical contribution to the art is the product which is enabled by the disclosure, in this case compositions containing specific milk components (including casein), and not the invention itself (or the idea), as set out here in the claims and in the consistory clause.
95. Finally, as an aside I acknowledge that this determination brings into question whether the amendment that was made during examination to incorporate the specific form of the invention defined by the present claims and corresponding consistory clause was allowable. This issue was not raised in the opposition, and I have not considered the matter, and the pursuant issue of priority, any further here.
96. Given my determination, it is unnecessary to further consider the specific submissions from the opponent on the definitions of caseinates, micelles and sequence homology. In summary, I consider that all claims lack support.
Sufficiency
97. Section 40(2)(a) of the Act requires that the 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 relevant art.
98. In CSR Building Products Ltd v United States Gypsum Company,[87] the delegate formulated the following three steps:
(1) Construe the claims to determine the scope of the invention as claimed;
(2) Construe the description to determine what it discloses to the person skilled in the art; and
(3) Decide whether the specification provides an enabling disclosure of all the things that fall within the scope of the claims.
[87] [2015] APO 72.
99. In Evolva SA,[88] the third question was reformulated in the following two-step consideration:
(1) Is it plausible that the invention can be worked across the full scope of the invention?
(2) Can the invention be performed across the full scope of the claims without undue experimentation?
[88] [2017] APO 57.
100. This approach has found approval with the Federal Court.[89]
[89] Cytec Industries Inc v Nalco Company, supra at [143]-[146].
101. The gist of the opponent’s submissions was that, for similar reasons to those outlined for the ground of support, the applicants have not demonstrated that the invention could be performed across the full scope of the invention. They also argued that the evidence of the products subsequently made by Mr Jhala suggested that the applicant needed to develop process steps which are not disclosed in the specification and are not part of the common general knowledge in order to make anything within the scope of the claims. In particular, the products rely on the use of PD cream as a base, but there is no discussion of this base product in the specification, and the examples neither use nor result in a product like the PD cream.[90]
[90] OS at [85].
102. The opponent acknowledged that it is reasonable that the skilled person would be able to prepare some types of products based on their common general knowledge. For example, Dr Golding stated that the ability to make a substitute dairy product with only alpha-lactalbumin and beta-lactoglobulin with ‘generally used methods’ would vary depending on the nature of the dairy product that was being approximated because the protein component of milk is important for many foods.[91] He considered that products that are traditionally made with whey proteins could be made with just recombinant a-lactalbumin and b-lactoglobulin, for example ricotta. Dairy products that don’t rely on milk proteins for their structural or functional properties, such as milk or cream, might also be possible since their structural and functional properties are largely provided by lipids, and so long as those components remain, he considered that swapping the native milk proteins for a subset of milk proteins would be unlikely to have a significant effect on the final product.[92] I note as an aside that Dr Golding’s evidence on this point is predicated on the assumption that recombinant whey proteins obtained from a fungal expression system have similar properties to the wild-type whey proteins, which as noted above, does not appear to be the case from Mr Jhala’s evidence.
[91] Golding at [6.5].
[92] Golding at [6.8].
103. Dr Golding went on to say that other types of products would have required a significant amount of experimental work to make a substitute with just α-lactalbumin and β-lactoglobulin, because specific protein functionalities are required to achieve desired properties such as taste, texture, structure and melting behaviour. One for one replacement of casein with a non-casein protein would be unlikely to replicate the properties of any casein-structured product such as cheese which generally rely on casein for the protein network that is the basis of their structure, and which provides the desirable sensory characteristics in terms of flavour and texture.[93]
[93] Golding at [6.10].
104. The applicant submitted that the opponent’s arguments were directly contradicted by the fact that Mr Jhala produced food compositions according to the claims, which were said to be obtained by conventional methods.[94] In particular, Mr Jhala described the preparation of products that contain α-lactalbumin and β-lactoglobulin as the sole milk protein component:
(a) Substitute cream (PD cream)
(b) Frozen dessert
(c) Cream cheese
(d) Yoghurt, and
(e) Sour cream.
[94] AS at [218].
105. Mr Jhala described the preparation of a 40% fat PD cream using water (52.6%), sunflower oil (26.4%), coconut oil (12.6%), sugar (4%), β-lactoglobulin (2.4%), α-lactalbumin (0.8%), mono and diglyceride emulsifier (1.0%) and mineral blend (0.3%).[95] The dry ingredients were mixed with warm water using a standard high shear mixer, pasteurised, homogenised and cooled. I note that the quantities used in the composition correspond in most respects to the theoretical cream formulation provided in Table 12, with the exception that α-lactalbumin (0.8%) and β-lactoglobulin (2.4%) are used in place of micellar casein (2.4%) and whey protein (0.6%). This suggests to me that the β-lactoglobulin is substituted for the casein protein. Mr Jhala went on to state that he supervised the preparation of the other products, which he said were made using traditional methods ordinarily used to make the corresponding dairy product. The key difference was said to lie in the use of the PD cream base rather than the usual cream component,[96] but I note that additional β-lactoglobulin is used to make the final products (with no further α-lactalbumin).[97] These therefore do not appear to be “traditional methods” since the common general knowledge in the art does not include the use of β-lactoglobulin as a food additive by itself.[98]
[95] Jhala at [25].
[96] Jhala at [28].
[97] Jhala at [29], [33], [37], and [41].
[98] AS at [112].
106. While the opponent’s submissions were directed at the need for the PD cream for the preparation of the various dairy substitute foods, I consider the root of the issue lies with the functional properties of recombinant α-lactalbumin and β-lactoglobulin made using fungal expression systems. In particular, Mr Jhala stated that the key differences between recombinant α- lactalbumin and β-lactoglobulin produced by a fungal expression system and that formed by a mammalian cell and extracted from bovine milk are that the recombinant proteins are produced in a pure form which is free of other components generally present in a whey protein concentrate or whey protein isolate (WPI), and differences in post-translational modification, including glycosylation and protein folding.[99] As noted above, he stated that α-lactalbumin and β-lactoglobulin can be used to replace casein and provide properties such as structure, texture, mouthfeel and aggregation properties traditionally attributed to casein.
[99] Jhala at [17].
107. Dr Schoenfuss stated that fungal produced proteins are likely to gel better than mammal produced proteins because of the known differences in glycosylation and folding, and that it is a general rule that fungal-produced protein is more likely to expose hydrophobic parts of the protein, and to aggregate and gel better than its mammalian counterpart.”[100] In contrast Dr Lucey stated that substituting casein with whey proteins would result in weaker, softer gels with altered mouthfeel, assuming some other ingredient like starch can assist in forming some type of gel.[101] He noted that Dr Schoenfuss provided no data to support an opinion of different folding or glycosylation patterns in recombinant proteins, and recent studies on non-glycosylated recombinant whey proteins from microbial expression systems have similar folding to bovine forms.[102]
[100] Schoenfuss 3 at [25]-[26].
[101] Lucey at [3.16].
[102] Lucey at [4.10] and JAL-5.
108. On balance, I am not satisfied that the evidence clearly establishes that the properties of recombinant α-lactalbumin and β-lactoglobulin produced by fungal expression systems were common general knowledge, or indeed even known, at the time of filing of the application. The evidence differs as to the characteristics that would be possessed by recombinant proteins and there is no information provided in the specification as to the properties of each of the two proteins or the mixture, including gelling properties. While Mr Jhala states that he has personally observed that recombinant α-lactalbumin and β-lactoglobulin provide important properties such as structure, texture, mouthfeel and aggregation properties traditionally attributed to casein, he did not appear to glean these properties from the disclosure in the specification or from the common general knowledge, but rather from his specific experience.
109. I consider that the specification provides no guidance, or even a suggestion, that α-lactalbumin and/or β-lactoglobulin 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.
110. This extends further to the definition of milk proteins to have as little as 90% identity with the wild-type proteins. On the facts of the case, my determination above, and specifically the lack of any detail or common general knowledge as to the relationship between the structural (such as glycosylation) and functional properties (such as gelation), it would be an undue burden for the person skilled in the art to work the invention across the full scope of the claimed matter.
111. In summary I consider the specification does not 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.
Utility
112. Section 18(1)(c) of the Act requires that the claimed invention be useful.
113. A useful summary of relevant principles was provided by the Full Court of the Federal Court in Artcraft Urban Group v Streetworx :
It is “no objection” to the validity of an innovation patent granted under the Act that it is “commercially impracticable”. The utility of the patent depends upon whether, by following the teaching of the specification, the result claimed is produced...
The “basic principle” of inutility is that if an invention “does what it is intended by the patentee to do, and the end attained is itself useful, the invention is a useful invention”... What the invention is “intended” to do is a matter to be gathered from the “title and the whole of the specification”.
Put another way, the two questions are: first, what is the promise of the invention derived from the whole of the specification?; second, by following the teaching of the specification, does the invention, as claimed in the patent, attain the result promised for it by the patentee?... Further, “everything” that is within the scope of a claim must be useful, that is, attain the result promised for the invention by the patentee. [citations omitted][103]
[103] Artcraft Urban Group Pty Ltd v Streetworx Pty Ltd [2016] FCAFC 29 at [118]-[121].
114. The opponent submitted that the application promises:
“…a dairy substitute or composition that has desirable flavor and performance characteristics, e.g., a composition that replicates dairy flavors, minimizes 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.”[104]
[104] OS at [117], citing the specification at page 2, lines 20 to 25.
115. The applicant accepted that the object of the invention was reflected in the above passage from the specification inasmuch as it related to a dairy substitute or composition that has desirable flavour and performance characteristics. However, they noted that the specific characteristics in the remainder of the quoted passage were exemplary and not promissory. They submitted that contrary to the evidence and arguments put forward by the opponent, the application does not promise that the dairy substitute food is identical to any particular dairy product in all respects and does not promise that it will have exactly the same flavour, same appearance, same aroma and same mouthfeel as any particular dairy product.
116. The opponent submitted that a composition that includes only one (or less than all) characteristics of a dairy food product would not meet the promise made, and that it was apparent from the evidence that some of the food compositions that fall within the scope of the opposed application will not fulfil the promise made and it would not be possible to make the full range of products covered by the claims using a recombinant β-lactoglobulin protein and a recombinant α-lactalbumin as the only milk proteins.[105] The opponent argued that it is apparent from the evidence that the application claims things which are not useful, since each of the claims requires that the recombinant proteins are 90% identical to the bovine protein amino acid sequence, and that such proteins will have very different functional properties to the bovine protein and will not be useful. A person skilled in the art would need to undertake a significant and lengthy research and development programme to determine how the modified proteins can be used in combination with other ingredients and processing conditions to create products with one or more properties of dairy products.[106] They submitted that it was not to the point that the skilled addressee might know which changes to avoid because a claim is bad if it covers means that will not produce the desired results even if a skilled person would know which means to avoid.[107]
[105] OS at [119].
[106] OS at [115].
[107] OS at [116].
117. I agree with the submissions by the applicant to the extent that the claim does not require that the food product defined by the claims are identical to the corresponding dairy products. However, the parties agree that the promise of the invention includes both desirable flavour and desirable performance characteristics. The claims, however, define that the food composition has as few as one of the listed characteristics of a dairy food product. The applicant argued that Claim 1, by its proper construction, is to a dairy food composition, and therefore a dairy product that is not an acceptable dairy substitute food would not fall within the scope of the claim. This particular submission highlights the concerns I identified during my construction of the claims as to the clarity and undue burden associated with determining whether a product would fall within the scope of the claims.
118. Notwithstanding my concerns in this regard, the opponent has not established by evidence that the claimed invention would not produce a useful result in any particular case,[108] such as whether a product possessing only one of the defined features would constitute a dairy substitute food but not meet the promise of the invention. Admittedly this task is not assisted by the manner in which the invention is claimed, nor by the late inclusion of the evidence of Mr Jhala, which shows that compositions falling within the scope of the claims could be prepared, albeit by means that required additional information and research to achieve such a result. In any case, I consider the opponent’s submissions essentially go to the issue of whether the specification is sufficient and the extent to which research would be required to work the invention, rather than whether the promise of the invention has been met.
[108] Apotex Pty Ltd v Astrazeneca AB (No 4) (2013) 100 IPR 285 at [352].
119. On balance I am not satisfied that the opponent has discharged the onus in establishing that the claims lack utility.
Conclusion
120. The opposition is successful.
121. The claims lack support, and the specification does not 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.
122. Under the circumstances I see no means by which the applicant could amend the specification to overcome the deficiencies identified. However, I will provide the applicant two (2) months from the date of this decision to file amendments to attempt to overcome the deficiencies.
Costs
123. Costs generally follow the event. I see no reason to depart from that approach.
124. The opposition has been successful. I therefore award costs according to Schedule 8 against the applicant, Perfect Day Inc.
Leslie F. McCaffery
Delegate of the Commissioner of Patents
Annex
Claims
1. 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 αlactalbumin 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).
2. The food composition of claim 1, wherein:
the recombinant β-lactoglobulin 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; 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.
3. The food composition of claim 1, wherein the fungal cell is selected from the group consisting of: a strain of Aspergillus nidulans, a strain of Aspergillus niger, a strain of Aspergillus oryzae, a strain of Candida albicans, a strain of Trichoderma reesei, a strain of Chrysosporium lucknowense, a strain of Fusarium gramineum, a strain of Fusarium venenatum, a strain of Physcomitrella patens, and a strain of Neurospora crassa.
4. The food composition of claim 1, wherein one or both of the recombinant β-lactoglobulin protein and the recombinant α-lactalbumin protein has been secreted by a fungal cell.
5. The food composition of claim 1, wherein the food composition does not include an animal-derived compound.
6. The food composition of claim 1, wherein the food composition does not include any compound isolated from a milk produced by a mammal.
7. The food composition of claim 1, wherein the food composition does not include at least one compound otherwise present in a mammal-produced milk.
8. The food composition of claim 1, wherein the food composition comprises a plurality of micelles.
9. The food composition of claim 8, wherein the plurality of micelles comprises one or both of the recombinant β-lactoglobulin protein and the recombinant α-lactalbumin protein.
10. The food composition of claim 1, wherein the food composition comprises one or more lipids selected from the group consisting of: plant-derived oils, plant-derived monoglycerides, plant-derived diglycerides, plant-derived triglycerides, plant-derived free fatty acids, and plant-derived phospholipids.
11. The food composition of claim 1, wherein the one or more sweetening agents are saccharides selected from the group consisting of: glucose, mannose, maltose, fructose, galactose, lactose, sucrose, monatin, and tagatose.
12. The food composition of claim 1, wherein the one or more sweetening agents are artificial sweeteners selected from the group consisting of: stevia, aspartame, cyclamate, saccharin, sucralose, mogrosides, brazzein, curculin, erythritol, glycyrrhizin, inulin, isomalt, lacititol, mabinlin, malititol, mannitol, miraculin, monatin, monelin, osladin, pentadin, sorbitol, thaumatin, xylitol, acesulfame potassium, advantame, alitame, aspartame-acesulfame, sodium cyclamate, dulcin, glucin, neohesperidin dihydrochalcone, neotame, and P-4000.
13. The food composition of claim 1, wherein the ash comprises one or more of: calcium, phosphorous, phosphate, potassium, sodium, citrate, sulfate, carbonate, chloride, magnesium, iron, copper, zinc, manganese, selenium, iodine, retinol, carotene, vitamins, vitamin D, vitamin E, vitamin B12, thiamin, and riboflavin, or a salt(s) thereof.
14. The food composition of claim 1, wherein the ash has a final concentration in the food composition of about 5% w/w to about 7% w/w.
15. The food composition of claim 1, wherein the food composition is selected from the group consisting of: a yogurt, a cheese, a milk, a butter, a caseinate, a cream, an infant formula, an ice cream, a frozen custard, a cottage cheese, a cream cheese, a crème fraiche, and a curd.
16. The food composition of claim 1, wherein the food composition is a powder composition.
17. The food composition of claim 15 wherein the food composition is a yogurt.
18. The food composition of claim 15, wherein the food composition is a butter.
19. The food composition of claim 15, wherein the food composition is a caseinate.
20. The food composition of claim 15, wherein the food composition is a cream.
21. The food composition of claim 15, wherein the food composition is an ice cream.
22. The food composition of claim 15, wherein the food composition is a frozen custard.
23. The food composition of claim 15, wherein the food composition is a cottage cheese.
24. The food composition of claim 15, wherein the food composition is a cream cheese.
25. The food composition of claim 15, wherein the food composition is a crème fraiche.
26. The food composition of claim 15, wherein the food composition is a curd.
27. The food composition of claim 7, wherein the food composition does not include lactose.
28. The food composition of claim 7, wherein the food composition does not include a
hormone.
29. The food composition of claim 15, wherein the food composition is a milk.
30. The food composition of claim 15, wherein the food composition is a cheese.
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