QIP Nominees Pty Ltd v Marlow Foods Limited
[2023] APO 19
•17 April 2023
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
QIP Nominees Pty Ltd v Marlow Foods Limited [2023] APO 19
Patent Application: 2016211049
Title:Edible fungi
Patent Applicant: Marlow Foods Limited
Opponent:QIP Nominees Pty Ltd
Delegate:Felix White
Decision Date: 17 April 2023
Hearing Date: 10 May 2022, by videoconference
Catchwords: PATENTS – edible fungal composition suitable for vegans – opposition under s59 – inventive step – clarity – support – sufficiency – utility – nature of the invention and the technical contribution – nature of problem to be solved – significance of acetate ions – opposition succeeds for lack of inventive step of claims 1-14, 18, 21-29 but fails on other grounds – opportunity to amend - costs awarded
Representation: Patent attorney for the applicant: John Landells, FB Rice
Counsel for the opponent: Craig Smith
Patent attorney for the opponent: FPA Patent Attorneys
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2016211049
Title:Edible fungi
Patent Applicant: Marlow Foods Limited
Date of Decision: 17 April 2023
DECISION
The Opposition succeeds on the grounds of lack of inventive step for claims 1-14, 18 and 21-29 and fails on the other grounds. I allow the Applicant 60 days from the date of this decision to propose appropriate amendments. I award costs according to Schedule 8 in favour of the Opponent.
REASONS FOR DECISION
Background
Australian patent application 2016211049 (“the application”) is the national phase entry of international application PCT/GB2016/050144 in the name of Marlow Foods Limited (“the Applicant”) and claims priority to UK patent application 1501320.4 with a priority date of 27 January 2015. It entered the Australian national phase on 11 July 2017. Following a direction from the Commissioner, examination was requested on 18 October 2018 and the application proceeded to acceptance which was advertised on 19 December 2019.
A notice of opposition under s59 of the Patents Act 1990[1] (“the Act”) was filed on 19 March 2020 by QIP Nominees Pty Ltd (“the Opponent”). The Statement of Grounds and Particulars (“SG&P”), filed on 19 June 2020 listed grounds of opposition as lack of manner of manufacture, lack of novelty, lack of inventive step, lack of utility, lack of clarity, lack of clear enough and complete disclosure, lack of best method and lack of support. The SG&P also contested the entitlement to priority.
[1] All statutory references are to this Act and the associated Patents Regulations 1991 unless indicated otherwise.
The evidence tendered in this proceeding is as follows:
In Support Filed 21 September 2020 Declaration of David Moore (“Moore #1”) Exhibits DM-1 to DM-32 In Answer Filed 24 February 2021 Declaration of Timothy Finnigan (“Finnigan”) Exhibits TF-1 to TF-7
In Reply Filed 26 April 2021 Second declaration of David Moore (“Moore #2”) Exhibits DM-33 to DM-37 Declaration of John Leslie (“Leslie”) Exhibits JL-1 to JL-13 Declaration of Ramin Pirzad (“Pirzad”) Exhibits RP-1 to RP-5
Prior to the hearing there was a dispute between the parties as to whether the Pirzad declaration was properly in reply, and whether further evidence tendered by the Applicant on 23 July 2021 should be considered under the provisions of Regulation 5.23. As set out in a letter from the Commissioner’s delegate on 18 November 2021, this was resolved to the effect that the Pirzad declaration is properly in reply and that none of the additional evidence should be consulted, as it was not “likely if not certain to change the outcome of the opposition”. I have therefore limited my consideration to the evidence set out above.
The Applicant filed an amendment to the accepted specification under s104 on 11 February 2021. These amendments were unopposed and were allowed on 4 June 2021. This amended specification forms the basis of the present decision.
Subsequent to the amendment to the specification, the Opponent dropped some of the grounds from the SG&P, and only pressed the following grounds at the hearing:
·Lack of manner of manufacture
·Lack of inventive step in view of
i.Common general knowledge
ii.D8 (WO1996/021362)
iii.D13 (US4663171)
iv.D18 (US4880654)
·Lack of support
·Lack of sufficiency
·Failure to disclose best method
·Lack of clarity
·Lack of utility
Applicable Law
The present application is governed by the Act as amended by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 as the application was filed after 15 April 2013. Thus, the standard of proof that applies in the present case is the balance of probabilities. I must accept the application if I am satisfied, on the balance of probabilities, that the application complies with the Act. If I am not so satisfied, then I can refuse the application, but not before giving the Applicant a reasonable opportunity to amend (subsection 60(3B)).
The opposed application
The opposed application consists of thirteen (13) pages of description, one figure and twenty-nine (29) claims.
The description begins with a background statement that edible filamentous fungi had been used as meat substitutes such as those sold under the trademark QUORN, and that in such uses, filaments of the fungi are bound together with egg albumin to resemble muscle fibres and produce a meat-like appearance and texture. The description then sets out that it is an object of the present invention to reduce or eliminate the amount of egg albumin used, e.g. to reduce cost or to make a product suitable for vegans. The latter embodiment is pointed out specifically at page 1A.
10.At the bottom of p. 1 the description states “According to a first object aspect [sic] of the invention, there is provided an edible formulation comprising edible fungal particles of a filamentous fungus and calcium ions.”
11.The description at p. 2-3 goes on to describe properties that the edible formulation “may”, “preferably” or “suitably” have. These include: being a meat substitute; the amount of filamentous fungus (5 to 80 wt%); the amount and location of calcium ions (2,000 or more mg/Kg fungus, 0.1 to 1 wt% of the total product) which can be intracellular or extracellular; the presence of water, polysaccharides, alginate, gluten or additional protein sources. My understanding of this (and indeed most of the following passages) is that while these properties may be desirable, they are not essential to the invention.
12.At the passage bridging p. 3-4 the description states that calcium chloride, if used as the calcium source, may give a disagreeable taste. The formulation therefore preferably includes acetate moieties (e.g. as calcium acetate) which have been found to counter this disagreeable taste.
13.At p. 5-6 the description gives information about the fungal particles. It discloses that the filamentous fungi used preferably do not produce fruiting bodies, but if fruiting bodies are present it is preferable to have less than 20% fruiting bodies, ideally none at all. It discloses that preferable fungi have a cell wall including chitin, chitosan, polymeric glucosamine and/or beta-glucans. The description refers to known fungal strains with reference to earlier patent documents (WO00/15045, WO96/21361, WO95/23843) and a strain of Fusarium venenatum A3/5 deposited at the ATCC (PTA-2684). The description states that the fungal particles are preferably non viable and treated to reduce their RNA content. Preferential values for the length, diameter, and aspect ratio of the fungal filaments. The weight ratio of fungus to water is definitively stated to be at least 0.05 on a dry matter basis.
14.The description then states that the formulation may be provided in a package, which may also comprise a receptacle, and gives preferable amounts of the formulation in the package (e.g. at least 10g fungal particles or 50g total).
15.The description then describes, at p. 6-7, a second aspect of the invention which is making an edible formulation by contacting a formulation of edible filamentous fungal particles with calcium ions. The formulation prepared “may” be as described in the first aspect, and the description goes on to repeat some preferable properties of the fungal particles that had been described earlier such as low RNA content.
16.The description concludes with five Examples as specific embodiments of the invention. After some definitions of materials used in the Examples (including mycoprotein paste), the description states at p. 8 lines 10-14 that “It is found that the addition of calcium cations (via calcium chloride and calcium acetate) to the ingredients described in the examples produce a rise in firmness and produces acceptable quality of the product produced. It is believed the calcium cations interact with the mycoprotein paste to increase its firmness and strength.”
17.Example 1 relates to a general method for producing mycoprotein-containing products with reference to Figure 1 (the only figure) which I will reproduce below:
18.In this general method, mycoprotein paste (referred to in the figure as “Mycoprotein”) is mixed with other ingredients as desired to produce a homogenous mass, which is formed and then steamed. The chilling step is said to improve the texture of the product by firming it. The size reduction process is said to be optional – the freezing step is said to be a second texturization step. The final texturisation is said to be 7 days storage at -18oC for at least seven days after packaging.
19.It is worth noting at this point that “mycoprotein paste” is defined quite specifically at p. 7 lines 26-35 as being a mass of filamentous fungus derived from Fusarium venenatum A3/5 (ATCC deposit PTA-2684) with low RNA content and specified fungal hyphae parameters. It is said to be available from Marlow Foods Limited (the Applicant) and as being described in two earlier patent publications.
20.Examples 2-5 give tables of ingredients for making a variety of vegan products: “vegan pieces recipe”, “vegan mince recipe”, vegan burger recipe” and “vegan sausage recipe”. Notably all of these refer to the process of Example 1. Notably, the following ingredients are present in all recipes:
·Mycoprotein paste
·Water
·Calcium acetate
·Calcium chloride
·Potato protein
·Sodium alginate
·Vital wheat gluten
·Flavour
21.Additional ingredients and proportions of the shared ingredients vary according to the type of product. Although little turns on this, I note that all the products in the examples are suitable for vegans but there is no evidence of any comparison made between vegan and non-vegan products, nor any comparison of products with calcium ions vs those without. Indeed there is no evidence of any texture or palatability testing, notwithstanding the “finding” of “acceptable quality” described above.
The claims
22.The amended specification ends with 29 claims, all of which depend directly or indirectly from claim 1 (line breaks added for clarity):
1. An edible formulation comprising edible fungal particles of a filamentous fungus and calcium ions,
wherein said edible formulation includes 0 wt% of components derived from animals,
wherein said edible formulation includes at least 2,000 mg of calcium ions per Kg of filamentous fungus on a dry matter [sic],
wherein said edible formulation is provided in a package which includes at least 50 g of said edible formulation,
and wherein said fungal particles comprise cells of Fusarium.
23.The dependent claims further specify various aspects of the formulation, including the amount of fungal particles or protein, the ratio of calcium to fungus, the presence of other components in the formulation such as alginate or acetate.
Construction
24.The task of construing the specification and claims is one that should be approached through the eyes of the skilled worker and with reference to the specification as a whole; although evidence of what the experts understand the claims to mean can be useful for this task, the task is ultimately a legal on for the Commissioner’s delegate and it must be done above all with a generous measure of common sense.[2]
[2] Cf Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214 at 139
25.In the present case it seems to me that the description and claims could be (and indeed has been) characterised in two very different ways depending on the way that the reader approaches the specification. On the one hand, the specification could be read as solving the problem of making a vegan version of the QUORN™ [3] fungal meat substitute, which at the time the patent was filed required egg albumin to provide an acceptable texture. This is the perspective that is apparently endorsed by the Applicant and is reflected throughout their submissions.
[3] Notwithstanding Dr. Finnegan’s differentiation between the terms “mycoprotein” and “Quorn™” at paragraphs 55-59 of his declaration, the description refers to the trademark QUORN in relation to fungal meat substitutes and I am content to use the term QUORN™ to refer to Marlow Food’s Fusarium venenatum-based meat substitute.
26.On the other hand, the specification could be read as simply providing a formulation of Fusarium fungal protein suitable for vegans. This is the perspective adopted by the Opponent which is evident from e.g. paragraph 1-2 of their submissions.
27.As will be apparent from the following consideration, I have found myself in general agreement with the Opponent’s perspective.
The person skilled in the art
28.It is well established that many of the issues in an opposition are answered by reference to the person skilled in the art:
“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.”[4]
[4]Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at 70.
29.The hypothetical skilled person works in the field with which the invention is connected and is a non-inventive person or team likely to have a practical interest in the subject matter of the invention.[5] However it must be borne in mind that the person skilled in the art is not a real person but an artificial construct, a “pale shadow”[6] that is nonetheless useful as a tool of analysis.
[5]Op cit at 70-72.
[6] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at 23
Field of the Application
30.The application is entitled “Edible Fungi”. The opening paragraph of the specification states that it “particularly, but not exclusively, relates to edible formulations comprising edible fungal particles for use as meat substitutes”. Informed by the amended claims, I understand the field of the invention relates to edible formulations comprising fungal particles, not necessarily meat substitutes, which are suitable for vegans.
Common General Knowledge
31.Common general knowledge has been defined as something that “is generally known and accepted without question by the bulk of those who are engaged in the particular art”.[7] As an administrative decision maker I will draw inferences as to what common general knowledge is, based on my understanding of the available evidence.[8]
[7] British Acoustic Films Ltd v Nettlefold Productions (1936) RPC 221 at 250
[8] Commissioner of Patents v Emperor Sports Pty Ltd [2006] FCAFC 26 at 33
The expert witnesses
32.Dr Moore is a retired mycologist with more than 50 years research experience in mycology, biochemistry and genetics.[9] Although he has not directly researched on Fusarium[10] he has authored journal articles related to Fusarium mycoprotein[11] as part of a body of work that includes several hundred peer reviewed articles and a number of books including mycology textbooks, and he has had informal collaborations with researchers involved in the development of the QUORN mycoprotein.[12]
[9] Moore #1 at 1
[10] Moore #1 at 5
[11] Moore #1 at 14
[12] Moore #1 at 28
33.Dr Moore’s evidence in chief includes a CV of his research and publications in the field of mycology (paragraphs 2-16 and DM-1); a helpful summary of his understanding of knowledge in the field of fungal material as meat substitutes (17-35) including QUORN™ (28-35); vegan products (36-37); the use of calcium in foods as a nutritional substitute and as a firming agent (38-41); his comments on the sixteen prior art documents originally mentioned in the SG&P (42-156); his reading of the opposed application including the examples (157-179) and the claims prior to amendment (180-213); and his opinion as to the relevance of the prior art documents to the claims (214-256).
34.Some notable points:
·The Fusarium strain used in QUORN™ was selected from a large-scale screen; this fungus is grown in continuous culture with hyphae being harvested continuously;
·RNA levels in the fungus need to be reduced to meet WHO guidelines on uric acid toxicity; freezing the harvested fungus is important as ice crystals align the filaments to mimic muscle fibres;
·The fibres are set using a binder, which Dr Moore mentions as being egg albumin;
·Dr Moore was aware of an alternative mycoprotein meat substitute product produced using a different fermentation technique; and
·Dr Moore was aware of vegan QUORN™ products which use potato starch in place of albumin as a binder.
35.However it is important to note that this last point was mentioned with reference to an article (DM-7) written by Dr Moore after the priority date which also stated that both vegetarian and vegan QUORN™ formulations contain calcium chloride and calcium acetate.
36.Dr Moore’s evidence in reply includes comments on the amended claims (6-18), and comments on Dr Finnegan’s declaration relating to the nature of the invention (20-27), the production of QUORN™ at Marlow Foods Ltd (28-46), and responses to Dr Finnegan’s criticism of his evidence in chief (47-93)
37.Dr Finnegan is the Chief Scientific Advisor of the Applicant, where he has been employed since 1988. He clearly has an intimate knowledge of the Applicant’s technology.[13] Both prior to and during this employment he has been involved in the development of foodstuffs.[14] Dr Finnegan appears to draw a distinction between the production of mycoprotein paste raw material which is overseen by his colleague Dr Rob Johnson at an industrial fermentation site in Belasis business park,[15] whereas processing of the raw material into foodstuffs is carried out at a site in nearby Stokesley by food scientists such as himself.[16]
[13] See e.g. Finnegan at 3 and 68
[14] Finnegan at 3-15
[15] In Billingham, UK
[16] Finnegan at 62-66
38.Dr Finnegan’s evidence in answer includes his CV (5-53), evidence relating to his knowledge of production of QUORN™ at Marlow Foods Ltd (54-84) and commentary on parts of Dr Moore’s evidence in chief including Dr Moore’s knowledge of filamentous fungi as a meat substitute (85-131) and his opinions on the prior art (132-159).
39.Some notable points:
·Marlow Foods have separate facilities for producing mycoprotein paste and transforming it into foodstuffs. The “Food Scientists” responsible for the latter process need not have any knowledge about how the mycoprotein paste is produced.
·Dr Finnegan understands “Mycoprotein paste” to be the material defined in the present application as same, and differentiates it from QUORN™ which is a trademark of finished products.
·In Dr Finnegan’s opinion, texture creation is highly unpredictable and complex, and in particular the effects of egg albumin as a binder cannot be fully understood, and other similar gelling proteins such as whey do not create satisfactory texture.
·In general, Dr Finnegan’s evidence is written from a Food Science perspective in that he places more weight on firming and texturing requirements. Furthermore, Dr Finnegan does not believe Dr Moore has particular experience in food formulation and as such is not qualified to comment on Food Science aspects.
40.Prof Leslie is a professor of plant pathology who is trained in fungal genetics and has researched on Fusarium specifically.[17] He is clearly able to provide evidence as to the common general knowledge relating to Fusarium fungi.
[17] Leslie at 3-9
41.Prof Leslie’s declaration provides an overview of his knowledge on the size, complexity, diversity and toxicity of the genus Fusarium.
42.Dr Pirzad is a consultant whose evidence was limited to an attempt to source a sample of mycoprotein from the Applicant.
43.The field of the invention is edible formulations of fungal particles suitable for vegans. The Opponent submitted that the person skilled in the art is a person with knowledge of edible fungi and their incorporation into foods.[18] The Applicant drew attention to the description of fungal particles as meat substitutes in the description, and focused on the importance of food product development as opposed to simply the nutritional aspects of fungi.[19] As such the Applicant submitted that the evidence of Dr Finnegan should be preferred as he was more experienced in food product development.
[18] Opponents written submissions (“OS”) at 23
[19] Applicants written submissions (“AS”) at 17
44.Given that I have found the field as being edible vegan formulations containing fungal particles in general, it follows that knowledge of the nutritional properties of fungus would be at least as relevant as food product development to the nominal skilled worker in that field. With this in mind, I can use evidence of the expert witnesses to inform my conclusions as to what the hypothetical skilled person would have known or done. I will weigh this evidence as appropriate throughout my consideration.
Construction of Claims
45.Having established the field of the invention and the relevance of the expert evidence to the corresponding nominal person skilled in at field, I will attempt to construe the claims through the eyes that nominal skilled worker. Along with the usual cautions to construe with common sense and to take the specification into account without importing impermissible glosses, I will begin with a plain reading of the claims.[20]
[20] Per Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70; 81 IPR 228 at [118] – [120]
46.I have taken some dependent claims into account in construing claim 1 based on the venerable principle of construing against redundancy.[21]Other dependent claims that may become significant to grounds of this opposition will be discussed at the relevant point of the decision. But for the purposes of establishing the field of the invention, the skilled worker and common general knowledge, it is sufficient to begin with claim 1.
[21] The presumption is that each claim is of differing scope and, where possible, claims should be construed accordingly (Parkinson v Simon (1894) 11 RPC 493)
47.It is clear from claim 1 that the invention is directed to a packaged edible formulation at least 50g in weight.
48.“Edible” is not defined in the specification and the experts have not indicated specifically what they understand “edible” to mean. Dr Moore did not appear to explain what he understood “edible” to mean although at paragraph 181 he remarked that the “edible formulation” of claim 1 could encompass up to 12 million different fungi including those which are poisonous. As most of Dr Moore’s comments on the claims seemed to highlight unworkable embodiments, I am not convinced interpretation of “edible” is to be preferred. On the other hand, at paragraph 236 he understands wild mushrooms as edible formulations. Dr Finnegan, despite referring regularly to edible formulations, does not set out exactly what he understands the term to mean either.
49.The Macquarie Dictionary’s definition of edible as “fit to be eaten as food”. However the description uses the word “edible” to describe the particles themselves (p. 1 line 32, p. 6 line 32 and p. 7 lines 5-15) which strongly implies that it does not have any requirement for texture or palatability. Hence I have construed this term as simply meaning capable of being safely eaten.
50.It is also clear from claim 1 that the formulation is free of animal derived products i.e. is suitable for vegans.
51.It is also clear that the formulation contains particles of Fusarium fungus, although the nature of the particles and amount of the fungus in the formulation is not specified.
52.It is also clear that the formulation includes calcium ions in proportion to the amount of fungus (on a dry matter basis). It follows that if there is only a relatively small amount of Fusarium fungus in the formulation, then only a correspondingly small amount of calcium ions need be present.
53.Notably claim 1 is not limited to a meat substitute. Dependent claim 24 specifies that it is a meat substitute, however that claim does not specify the amount of fungal particles in the meat substitute.
54.Neither is Claim 1 is limited to Fusarium venenatum A3/5 which is the strain used for the commercial QUORN™ product. (This is specified in dependent claims 27 and 29). The evidence on file suggests that most Fusarium fungi are known to be toxic.[22] Prof Leslie states that Fusarium venenatum A3/5 is “atypical” and “unusual” within Fusarium species in that it is “Generally Regarded as Safe”[23] but the experts recognised that at least one alternative Fusarium mycoprotein product is apparently under development.[24] Since I have construed “edible” as having a requirement for non-toxicity, and other non-toxic Fusarium strains clearly exist, I consider the claims can encompass the use of fungal particles from those strains.
[22] Moore #2 at 9-12, Leslie at 21-25
[23] Leslie at 26-27
[24] Moore #1 at 35 and 30, although Dr Finnegan disputes whether the 3F product is yet commercially available at 68
55.Claim 1 is therefore directed to:
· A packaged vegan foodstuff of 50g or more (i.e. a saleable ingredient or ready meal)
· Which comprises some unspecified amount of particles derived from an edible Fusarium fungus
· And which has at least 2000 mg of calcium per kg (dry weight) of the Fusarium
o Given that Fusarium naturally comprises up to 1800 mg/kg calcium[25] the claimed foodstuff only requires a relatively small amount of additional calcium to satisfy this integer.
[25] See Moore #2 at 69 and DM-37
What does this claim encompass?
56.The Opponent submitted that the claim was very broad, and that a range of possible foodstuffs could fall with the scope of the claims.[26] At the oral hearing, the Opponent submitted that claim 1 (and the majority of the dependent claims) encompass at least the embodiments set out below. Given my construction above, I find these embodiments to be consistent with the scope of the claims.
[26] OS at 2
Fortified Fusarium
57.It appears to be common ground that it was common general knowledge that Fusarium fungus is a source of protein suitable for vegans (albeit considered unpalatable in its raw form). The Opponent submitted at the oral hearing that vegan diets often require supplementation for minerals, such as calcium, which are usually found in an animal-based diet. Although there is no declaratory evidence on this point, I understand this to be the case.
58.I am satisfied that a package of crude Fusarium fungal protein supplemented (“sprinkled”) with calcium would fall within the scope of claim 1 and would not be an absurd construction.
Tofu pie
59.The Opponent pointed out there is no lower limit on the amount of Fusarium protein in the composition. Because the content of calcium in the formulation is defined relative to the amount of Fusarium protein, a high-calcium vegan food product, such as one containing tofu[27] would fall within the claims if it contained a small amount of Fusarium protein. So I am satisfied that the embodiment of a vegan tofu pie with a small amount of Fusarium protein would fall within the scope of claim 1 and would not be an absurd construction.
[27] According to tofu can contain 1300 mg/Kg calcium
Alginate gel
60.Alginate gels are mentioned in the art[28] as texturing agents for meat substitutes, and are clearly vegan. Calcium can be used as a crosslinking agent for alginate gels. Therefore, a vegan meat substitute based on Fusarium protein using a calcium-crosslinked alginate texturing agent would be likely fall within the scope of claim 1 as long as the calcium alginate provided the missing 200 mg Ca2+ per kg of Fusarium (a ratio of 1:5000 w/w). This construction was relied upon by the Opponent for one of its inventive step arguments and I also do not consider it unreasonable.
[28] See e.g. OS 59 with reference to D8 (WO96/21362), D13 (US4663171) and D18 (US4880654)
Vegan QUORN™
61.An embodiment that is specifically contemplated by the description is a QUORN™ type meat substitute that is suitable for vegans. As described in the specification, (and consistent with the evidence of Dr Finnigan) QUORN™ was a commercially successful, palatable vegan meat substitute based on Fusarium venenatum A3/5 mycoprotein paste. Previous commercial formulations had required egg albumin as a firming agent. Therefore, a vegan form of QUORN™ in which calcium replaced egg albumin as the firming agent would certainly fall within the scope of the claims.
62.I asked the Applicant during the hearing whether it would be reasonable to construe the Fusarium fungal particles in claim 1 as limited to the “mycoprotein paste” used in the present Examples. The Applicant’s submission was that it should not be so limited and could encompass other Fusarium derived edible particles. Therefore, consistent with my construction above, it is clear that the claims extend beyond the Vegan QUORN™ embodiment.
Clarity
63.The standard for clarity is that the scope of the claimed monopoly is clear and can be understood by the skilled addressee – e.g. there is a “workable standard” that a potential infringing product can be assessed against.[29]
[29] Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd [1980] HCA 9 at [46].
64.The Opponent’s position on clarity is that the terms “edible” and “package” are unclear.[30] With respect to “edible”, they assert there is no workable standard for whether “edible” has a requirement for palatability or non-toxicity, and if so, that there is no clear level where a formulation becomes edible. With respect to “package”, they assert there are no structural or functional requirement for the package and therefore no way of assessing whether something is a package or not. The Opponent questions whether mesh, open boxes, wrapping paper or bowls would constitute a package.
[30] OS at 129-130
65.With respect to the term “edible”, I have found above that that this term simply means “capable of being safely eaten. Although arguably a consumer might not be in a position to ascertain whether a product is toxic or not, a food technologist undoubtedly would.[31]
[31] Dr Leslie was aware that at least the A3/5 strain was Generally Regarded as Safe (Leslie at 27). It follows that any other safe Fusarium strains would be generally known to the skilled worker.
66.With respect to the food packaging point, I cannot see any difficulty in any addressee (be they a food technologist or a consumer) identifying whether a food product is packaged as opposed to unpackaged.[32] There is nothing in the evidence on file to suggest that there is any such difficulty either. The experts do not seem to identify any confusion as to what a “package” is.
[32] With respect to the Opponent’s hypotheticals, wrapping paper could be plausibly construed to be packaging (at least in some cases) as could, potentially, mesh (e.g. orange bags). It seems less likely that the others could be construed as packages. This does not affect my conclusion that an addressee would be able to make a determination without difficulty whether any given product was “packaged” or not.
67.On balance, I am satisfied that these terms can be understood by the skilled addressee. I do not see any difficulty in construing a packaged edible formulation – it clearly must be suitable for consumption so the Fusarium used in the formulation must be sufficiently non-toxic. It seems clear from the evidence that the skilled worker would be able to recognise and distinguish suitably non-toxic Fusarium strains for use in the claimed formulation.
68.The ground of lack of clarity is not made out.
Inventive step
Legal standards
69.The test for whether an invention is obvious is to ask whether it would have been a matter of routine to proceed to the claimed invention. In Wellcome Foundation Ltd v V. R. Laboratories (Aust.) Pty Ltd[33] Aickin J stated:
[33] (1981) 148 CLR 262 at 286
“The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they are the steps of the inventor or not.”
70.More recently, the High Court in Aktiebolaget Hassle v Alphapharm Pty Ltd[34] referred to this approach with approval and further held:
[34] (2002) 212 CLR 411 at 53
“That way of approaching the matter has an affinity with the reformulation of the ‘Cripps question’ by Graham J in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157. This court had been referred to Olin in the argument in Wellcome Foundation. Graham J had posed the 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 invention] in the expectation that it might well produce [the desired result]?'
That approach should be accepted.”
71.This “reformulated Cripps question” is not the only way to approach inventive step but it is a useful approach that has been endorsed by the High Court.
72.The expectation of success was considered in Nichia Corporation v Arrow Electronics Australia Pty Ltd[35] (“Nichia”) which was mentioned only briefly in the Opponent’s written submissions but was expanded upon by the Opponent at the oral hearing. The Full Court in Nichia noted that the relevant test is merely an expectation that the steps may work, and stressed that “directly led” and “in the expectation” in the Cripps question are not separate tests but are a single qualified question, citing with approval the observation in Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft[36] that 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”.
[35] [2019] FCAFC 2
[36] [2014] FCAFC 73 at 71
The Full Court in Nichia also pointed to the importance of correctly construing the problem to be solved (also described as the outcome to be sought or the useful result). It agreed that considering the issue of obviousness by reference to “the outcome that is sought” is an orthodox approach.[37]
[37] Nichia at 81
In the case at issue in Nichia, the Full Court criticised the primary judgment for applying “too high a standard” of expecting a white LED which is durable, with good colour tone and high luminance,[38] whereas the primary judge had found that the claims and specification read as a whole disclosed that the invention in Nichia need meet only one of those objects.[39] The Full Court then emphasised that “the concept of a useful result, for the purposes of the Cripps question, cannot exceed that which the claims and the specification as a whole in the context of the prior art identifies as useful.”[40]
[38] Nichia at 120
[39] Nichia at 118
[40] Nichia at 119
However the Full Court did not accept the proposition that the qualitative aspects of the useful result needed to be integers in the claims[41] and cited with approval Middleton J in Eli Lilly and Co Ltd v Apotex Pty Ltd: “It is impermissible to divorce olanzapine from its context and subject it to an obviousness test that completely disregards its utility as an antipsychotic drug”.[42]
[41] Nichia at 68
[42] Nichia at 76, citing [2013] FCA 214 at 533
From the above guidance, the nature of the problem to be solved (referred to as “useful result” or “outcome to be sought” in Nichia) is critical to the determination of inventive step according to the reformulated Cripps question, as it is the nature of the problem to be solved which provides the context for determining the skilled worker’s expectation of success.
It also follows that the problem to be solved must be commensurate with the whole scope of the claims. It is not appropriate to use a problem associated with “too high a standard” that only applies to some but not all of the claim scope.
I note that the Opponent submitted that the reformulated Cripps question is not the only way to approach inventive step[43]: pointing out that other statements of the inventive step test include that there be ‘a scintilla of invention’, or ‘some difficulty overcome, some barrier crossed’, and something ‘beyond the skill of the calling’. Although this is relevant to the Opponent’s second line of argument, as will be seen from the following I am satisfied that the Opponent’s case for lack of inventive step can be made out using the conventional Cripps question approach.
[43] OS at 43-44
The Applicant’s submissions on the legal standards for inventive step highlighted the need to avoid hindsight[44] and that a “scintilla of invention” can be sufficient to establish inventive step.[45] However I do note that the Applicant’s submissions as to hindsight in particular are based on its formulation of the problem to be solved as a way of replacing egg albumin for texturizing filamentous fungal particles (i.e. producing vegan QUORNTM).[46]
[44] AS at 52-55 and 61
[45] AS at 56
[46] AS at e.g. 55, 60
The problem to be solved
As per the discussion of Nichia above, the problem to be solved must be something that “the claims and the specification as a whole in the context of the prior art identifies as useful”. Once again I am presented with a selection of different problems to be solved.
The Applicant’s preferred problem is replacing egg albumin as a binding agent within the “vegan QUORNTM” embodiment.
The Opponent presented three lines of argument, each of which with a different associated problem. The first line, presented in the oral hearing[47] is that the invention is directed to supplementing a vegan foodstuff with calcium. This is consistent with the “Fortified Fusarium” or “Tofu Pie” embodiments. The second line[48] is that there is no problem solved at all as there is no interaction between calcium and Fusarium protein demonstrated in the description. In the Opponent’s submission this would enliven the “no barrier crossed” principle of lack of inventive step. The third line[49] is that the invention is directed to providing firmness to a vegan foodstuff with alginate as a gelling agent. This is consistent with “Alginate gel” embodiment.
[47] And referred to tangentially at OS 52
[48] OS at 63
[49] OS at 64-67
Since I understand from Nichia that the problem to be solved should be one that is accomplished over the full scope of the claims, and I have found that all the above embodiments fall within the scope of the claims,[50] I am satisfied that either the Opponent’s first or third lines could provide appropriate problems.
[50] Since only part of a claim need be obvious for it to fail s18(1)(b)(ii) (cf OS at 45), it follows that a problem that only applies to a part of the claim is legitimate for the Cripps analysis, as long as the problem satisfies all the usual caveats such as being known to the skilled worker and not importing aspects of the solution.
Submissions
The Applicant’s submissions on inventive step are almost entirely from the perspective of solving the problem of replacing egg albumin as a binding agent. Although that is one possible problem to be solved, I have found above that it does not extend over the full scope of the claim and it falls foul of Nichia’s caution against “applying too high a standard” that is not shared by the other embodiments that fall within the claim scope.
To the extent that they engage with the other problems to be solved, the Applicant’s submissions appear to be as follows:
· The fact that calcium is a known ingredient does not make it obvious to combine it with filamentous fungal particles.[51] I am not convinced by this, as I am happy to accept that calcium supplementation of vegan food products would have been common general knowledge.
[51] AS at 69
· The amount of calcium ions required by the claim is significantly higher than that naturally present in Fusarium (at least 200 mg/Kg for claim 1, at least 6200 mg/Kg for claims 4, 3200 mg/Kg or more for claim 6, claim 5 specifies that all the calcium is extracellular) and is effective to provide at least some texture creation for the filamentous fungal particles.[52] I am not convinced by this. Although some of these mg/Kg levels appear quite high, they are measured with respect to the amount of Fusarium present, so if the product were to contain a relatively small amount of Fusarium (such as the “Tofu pie” embodiment) then much smaller amounts of calcium would satisfy the claims. I also note there is no requirement in the claims for texture creation. Based on my reading of the specification as a whole, any texture creation from calcium seems to come from the mixing of mycoprotein paste with the ingredients (including calcium) prior to carrying out the forming steps shown in Figure 1. However the claims are not limited to this and could include calcium added later.
[52] AS at 70
· With respect to the “Alginate gel” embodiment, the Applicant submits that “[t]he use of calcium ions in gelling agents is a different application to the specific use of a certain minimum amount of calcium ions in creating texture to filamentous fungal particles in the absence of egg albumin”.[53] I am not convinced by this either. The purpose, or “application”, of the calcium ions in the composition is not relevant for determining the scope of the claim, which merely requires the presence of calcium ions along with Fusarium particles.
[53] AS at 71
It might be the case that the Applicant’s arguments could be relevant for compositions that were made and formulated according to the examples of the specification (although I note that all the examples in the specification also contain the gelling agent sodium alginate). However currently no claims are limited to that.
D8
D8 does not provide a clear and unmistakable direction of a packaged formulation comprising the specified amounts of Fusarium particles and calcium. This is acknowledged by the Opponent, who did not press the ground of lack of novelty.
D8 is directed to textured foodstuffs comprising edible filamentous fungus (such as Fusarium[54]) mixed with edible hydrocolloids.[55] The hydrocolloid is disclosed as being preferably egg albumin and whey protein, or an alginate gel.[56] D8 discloses that alginates can be gelated either by heating or by addition of calcium ions.[57]
[54] D8 refers to Fusarium graminearum at p. 1 line 2 but Dr Moore understands this as a classification error for the fungus known now as Fusarium venenatum.
[55] See e.g. claim 1 of D8.
[56] See p. 2 lines 29-30, p. 3 lines 23-24 and claim 5 of D8.
[57] See p. 3 lines 23-29
The Applicant pointed out that in the preferred and exemplified embodiments of D8, egg albumin is used exclusively, and argues that any reading of a vegan formulation comprising calcium and alginate is hindsight. I disagree.
D8 clearly contemplates alginate as an alternative to egg albumin (see claim 5 of D8). I have previously concluded that providing firmness to a vegan foodstuff can be used as one of the problems to be solved for the Cripps question. From this point of view, the skilled worker would be motivated to choose the alginate embodiment over the egg albumin embodiment. The only option left is to choose the mode of gelation, which D8 clearly teaches either heat or calcium, and it is an accepted principle that the mere existence of alternatives does not preclude lack of inventive step.[58]
[58] OS at 46, accepted at AS 50.
This leaves the question of the amount of the calcium. Clearly D8 is silent as to the amount of calcium required. But I consider it more likely than not, on the balance of probabilities, that more than 200 mg per Kg[59] Fusarium would have been added to set the hydrogel, bearing in mind that the skilled worker would have had some freedom to vary the proportion of hydrogel:fungal particles. Inventive step does not require the accuracy of a sniper.
[59] As discussed above, Fusarium naturally contains up to 1800 mg/Kg calcium. Therefore only 200 additional mg calcium per kg Fusarium would be required. This is 1 part calcium per 5000 parts fungus.
At least claim 1 lacks inventive step in view of D8.
D13 and D18
I am less convinced by the Opponent’s submissions on these documents. Although both of them describe the use of calcium alginate gels as gelifying agents in foodstuff compositions, neither of them disclose Fusarium and D18 does not explicitly disclose fungal particles at all. From the point of view of the problem of providing firmness to a vegan foodstuff, I am not convinced that the evidence suggests that the skilled worker would have been directly led to the combination of Fusarium and calcium alginate.
Other lines of the Opponent’s argument
I have found above that at least claim 1 lacks inventive step in view of D8, from the perspective of the “Alginate Gel” embodiment and the associated problem of making a textured vegan foodstuff. I will briefly touch on the implications of their other lines of argument.
The first line (obviousness in view of common general knowledge, based on the “Fortified Fusarium” or “Tofu Pie” embodiments) appears to me to be even more potent. From the perspective of the associated problem of supplementing a vegan foodstuff, it does not appear that there would be any difficulty in adding calcium to a Fusarium based product such as that of D8, either in the form of calcium salts or in the form of a high calcium component such as tofu. In fact this argument would be equally applicable to other disclosures of Fusarium protein suitable for vegans (such as D7[60] or D9,[61] although these were not pressed at the hearing).
[60] WO 2002/090527 A1
[61] WO 95/23843 A1
The second line (that no problem has been solved at all) I have less sympathy for – clearly the Applicant has done something inasmuch as that they have created a number of vegan formulations that are apparently palatable. However the claims do not correspond in scope to the examples; and on the other hand, no submissions have been advanced that the specific examples in the application were obvious. I therefore do not see any value in following this line of argument further.
Dependent claims
The Opponent’s submissions on inventive step of the dependent claims[62] were cursory at best. The Applicant did not address them either, as its arguments were focused on the inventive step of claim 1. I can, however, accept that the Opponents assertion that “nor is there any suggestion that any other component (or ratio of components) listed in any of the dependent claims … gives rise to any invention or contributes the necessary inventive step” applies for some, but not all of the dependent claims.
[62] OS at 67
It is convenient to deal with the dependent claims in a number of groups:
· Amount of calcium (claims 4-7, 18)
· Amount of other nutritional components (claims 2-3, 8-14)
· Presence and amount of acetate (claims 15-17, 19-20)
· Properties of the package (claims 23-26)
· Properties of the Fusarium (claims 21, 27, 29)
· Method of making the composition (claim 28)
With respect to the amount of calcium, these are mainly expressed as being in relation to the amount of Fusarium protein (although claim 7 specifies a range of 0.1%-1% calcium total). In the case of the “tofu pie” embodiment[63] all of these claims could be satisfied by simply providing a small amount of Fusarium protein in a tofu based mixture.
[63] As noted above tofu naturally contains up to 0.13% calcium.
With respect to the other nutritional components, I note that at least water and alginate were already specified in D8. The features of non-wheat vegetable protein and gluten would also be provided by the “tofu pie” embodiment. There does not appear to be anything particularly significant about the weight ranges set out for the other nutritional components.
With respect to the presence of acetate, the specification indicates at p. 3 lines 30-34 that acetate has been found to counter the disagreeable taste of calcium chloride. This does strike me as solving a technical problem and there does not appear to be any evidence on file that acetate has been disclosed for the purpose before the priority date. Although Dr Moore does mention acetate in his evidence in chief, this is only in the context of D1 (which the Opponent appears to have conceded is not part of the prior art base under the grace period provisions) or Exhibit DM-7 (which was also published after the priority date). At the hearing the Opponent’s submissions on acetate were that it only related to flavour. However I can accept that improving palatability is a technical problem. Since nothing on file suggests providing acetate to solve this problem, I am satisfied that these claims have an inventive step.
The specification of size and properties of the package in claims 23-26 do not appear out of bounds of a typical packaged food product. I note that claim 24 specifies that the composition is a meat substitute, which is nevertheless disclosed in D8.
The features of the Fusarium including the strain nomenclature (IMI 145425 – cf p. 5 lines 19-20 of the instant description) and the reduced RNA content are also disclosed in D8 (p. 4 lines 21-25 and p. 5 lines 25-26).
Finally, the method of making the formulation by contacting the fungal particles with calcium does not add anything to the subject matter of the previous claims. It is difficult to imagine how one could create a composition comprising fungal particles and calcium in any other way.
In summary, claims 1-14, 18 and 21-29 lack inventive step.
Support
Legal standards
In their submissions on support, both parties referred to Burley J’s decision in Merck[64] which was the first Federal Court decision to consider the post-Raising the Bar support requirement. I note that this decision in turn referred to the Deputy Commissioner’s decision in CSR[65] which stated that the claimed invention must reflect the technical contribution of the application. The parties’ submissions pointed to a number of additional principles referred to in Merck, which were in turn mainly taken from the decision of the Supreme Court of the United Kingdom in Regeneron.[66]
[64] Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477
[65] CSR Building Products Limited v United States Gypsum Company [2015] APO 72
[66] Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] UKSC 27.
However I note that these principles, including
· Claims should give protection to things that could not have been envisaged without the invention but should not extend to ways of producing an outcome which owe nothing to the teaching of the patent;[67]
[67] Biogen Inc v Medeva Plc [1997] RPC 1 (“Biogen”)
· Claims which extend to products which cannot be made using the disclosure if the patent will exceed the contribution to the art; however this only applies to variables which significantly affect the utility of the product for the disclosed purpose;[68]
[68] Regeneron at 56(vii)
· Support may be satisfied by a “principle of general application” that enables a skilled worker to make products across the range claimed.
are mainly of use when the claimed invention defines a product by its properties (as was the case in Regeneron and Biogen) rather than a product defined simply by its constituent parts as is the case here. I also note (as did Burley J in Merck at 544) that UK jurisprudence corresponding to the Australian support requirement necessitates disentangling so-called “Biogen insufficiency” (which corresponds to lack of support) from “classical insufficiency”.
In the present case, the main difficulty appears to be establishing the technical contribution of the application.
There is minimal guidance on how to go about determining the technical contribution as it is recognised to be a task of construction.
In the case of a product claim, the contribution to the art has been said to be the ability of the skilled person to make the product itself.[69] A similar statement is seen at CSR at 112 quoting Neubeger LJ in Generics.[70]
[69] Merck at 542(ii) quoting Regeneron at 56(ii)
[70] Generics (UK) Ltd v H Lundbeck A/S [2009] RPC 13
That quoted passage of Neuberger LJ’s in Generics also suggests that the technical contribution can often be equated with non-obvious novelty, although elsewhere in Generics Walker LJ pointed out that the inventive step (or inventive concept) is not necessarily the same as the technical contribution and that a more useful test for technical contribution may be “how far forward has it carried the state of the art?”[71]
[71] Generics at 30
Another caveat is that a “mere mention” of a feature in the specification may not be sufficient to satisfy the support requirement.[72]
[72] Merck at 546 quoting Schering Biotech Corp.'s Application [1993] RPC 249 via CSR at 114
Given that the present claims appear to fall squarely into the category of “simple products” I will bear the above three factors in mind when assessing the technical contribution.
Submissions
The Opponent advanced a number of lines of argument in relation to support. On the one hand the Opponent submitted there is no technical contribution in the application at all.[73] On the other hand the Opponent submitted that the technical contribution is at best limited to the examples. The Opponent further presented a number of reasons why the claims are broad and not limited by any technical contribution.[74] I can summarise these as arguing that none of the integers in the claims appear to confer any technical effect; to the extent that a technical contribution is present in the examples the claims do not reflect the corresponding features; and the claim is open to other components that are likely to affect the properties so any technical contribution would not be reflected across the range claimed.
[73] OS at 79
[74] OS at 82-96
The Applicant identified their technical contribution as being the identification that a minimum amount of calcium ions can be used in place of egg albumin to increase firmness and strength in formulations of filamentous fungal particles to make a product suitable for vegans. In doing so, the Applicant pointed to statements on the first page of the application about the need to replace egg albumin and the general disclosure of “an edible formulation comprising edible fungal particles of a filamentous fungus and calcium ions”. The Applicant pointed to the stated effect of calcium cations to the ingredients described in the examples. The Applicant also pointed to the stated disclosure of an interaction between fungal particles and calcium ions.
The Applicant further sought to supplement the disclosure of the specification with evidence taken from D1[75] and D2[76] originally cited in the SG&P.[77]
[75] GB2516491 A
[76] GB2518725 A
[77] These documents, earlier patent publications by the Applicant, were not pressed for the grounds of novelty or inventive step. They would appear to be excluded from the prior art base under the grace period provisions of s24(1)(a).
I note that much of the Applicant’s submissions on support appear more directed to the sufficiency ground, with respect to the effort required by the skilled worker to carry out the invention.
The reference to extraneous evidence is likewise more relevant to the ground of sufficiency (it appears to relate to a principle from Regeneron that supplemental data can be used to confirm a prediction made in the description – to my understanding this relates to plausibility which is also an arm of the sufficiency test in Australian law).
Consideration – application of the CSR test
From the description as filed, I can see two potential technical contributions that relate to the invention of claim 1. One is the simple disclosure at p. 1 of a fungal formulation comprising calcium ions, supplemented with statements of preference from p. 2, 5 and 6 with respect to the amount of calcium ions, the identity of the fungus and the presence and size of the package. The other is the statement at p. 8 that acceptable firmness and quality of a vegan product is obtained by addition of calcium to the ingredients described in the examples.
If the first one is an actual technical contribution, it clearly corresponds to the invention of claim 1 (and corresponding contribution statements) can be found for the remaining claims. In favour of this possibility is the fact that for a simple product claim, all that is needed is the ability to make the product (which is satisfied by simply describing the product).
If the second one is in fact the technical contribution, the Opponent’s ground would clearly be made out. It is clear that the statement on p. 8 only relates to the Examples which are much narrower than the scope of claim 1. In favour of this possibility is that this passage points to at least an alleged benefit, and as such represents an improvement in the art. Also in favour of this possibility is that it corresponds more closely to the Applicant’s own submissions on technical contribution. However I am loath give evidentiary weight to those submissions – the Applicant cannot “choose” their own technical contribution in retrospect.
The standard for assessment of all grounds of this opposition is the balance of probabilities. Taking the above factors into account, and also taking into account that I considered the problem to be solved for inventive step to be much broader than that solved in the examples, I find that the balance falls in favour of the technical contribution of the application being the ability to make the claimed formulation.
This being so, neither claim 1 nor any of the other claims on file lack support.
Sufficiency
Legal principles
The principles governing s40(2)(a) (“Clear enough and complete enough disclosure” or “Sufficiency”) were first reviewed post the Raising the Bar Bill in Evolva SA [2017] APO 57 (“Evolva”), and they have been considered again by Burley J in Merck, quoting the following statement from the UK Supreme court:
The heart of the test is: Can the skilled person readily perform the invention over the whole area claimed without undue burden and without needing inventive skill?
In Evolva, the Deputy Commissioner set forth the following test:
Does the specification provide an enabling disclosure of all the things that fall within the scope of the claims, and in particular:
(a) Is it plausible that the invention can be worked across the full scope of the claim?
(b) Can the invention be performed across the full scope of the claim without undue burden? [78]
[78] Evolva at 45
Earlier in Evolva, the Deputy Commissioner had also found that:
An invention may be defined in general terms provided the specification discloses a principle of general application inasmuch as it can be reasonably expected the invention will work with anything falling within the scope of these terms.[79]
[79] Evolva at 37
Submissions
The Applicant’s submissions are to the effect that in view of the background material discussed in the specification (particularly earlier patents that describe the deposited Fusarium strain and methods of preparing filamentous fungi) and also in view of Dr Moore’s understanding of the state of knowledge at the priority date, the skilled worker would have no difficulty working the invention across the scope of the claims.[80]
[80] AS at 130-131
The Opponent’s submissions, insofar as they relate to application of principles to the facts, are that essential texturization steps are omitted[81] and that the starting material of mycoprotein paste was not commercially available.[82]
[81] OS at 111-114
[82] OS at 115
In my view the Opponent’s submissions in this regard seem more directed to the Best Method requirement than sufficiency (Best method will be discussed below) and I do not find them apposite to the facts of the present case.
Consideration
Turning to the first line of argument, there is in fact no explicit requirement for texturization in the claims at all. As to the second requirement, I am not aware of any legal requirement to be able to reproduce examples exactly e.g. with the same starting material. It is trite to say that claims will always include embodiments that cannot be easily obtained by the skilled worker. What is important is that all products within the scope of the claim will, if made, deliver the same general benefit intended to be generated by the invention.[83]
[83] Regeneron at 56 vii-viii
Which brings me back to the scope and nature of the claimed invention.[84] As I have found that the claims are broad enough to encompass a large number of embodiments such as “Tofu pie” or even “Fortified Fusarium” it does not make sense to assess the benefits of the invention against a more specific problem. Simply put, there are no “functional limitations”, such as requirements for palatability or texture in the claims. In order to carry out the invention across the scope of the claims it is merely sufficient to mix the claimed components together.
[84] This was also acknowledged by the Opponent at 106-107 of their submissions.
I therefore found the Applicant’s submissions persuasive, and the ground of lack of sufficiency not made out.
Best method
The best method requirement, as pointed out by the Opponent in their submissions[85] is a question of policy as part of the patent bargain: an applicant must act in good faith and not keep information required to get the best results to themselves. As succinctly summarised in Les Laboratoires Servier v Apotex [2016] FCAFC 27 (“Servier”) at 81 “the patentee was required to disclose, as an example of the implement, the implement with the better method of operation found to have been known to the patentee.”
[85] OS at 118-119
There are some cautions attached to this. The best method required to be disclosed must be related to the nature of the invention.[86] So concerns raised by the Opponent as to the identification of undisclosed flavours[87] are misplaced.
[86] Servier at 108
[87] OS at 123
Furthermore the question of whether the required disclosure has been met is a factual one: a useful test adopted by Bennet J in Expo-net[88] (adopted from South African jurisprudence and cited with approval by the Full Court in Servier) is as follows:
[88] Expo-Net Danmark A/S v Buono-Net Australia Pty Ltd (No 2) [2011] FCA 710
The applicant for revocation must show that the method which the patentee failed to disclose is a method of performing the invention; that the method is in fact a better method; that the method was known to the patentee at the time when the application was lodged; that the method is not disclosed in the specification; and that the patentee knew that the method was better than the method described in the specification.
In the present case, the Opponent relied on elements of Dr Finnigan’s declaration relating to appropriate texturisation steps whereas the specification only refers in general to steps of steaming, chilling and size reduction.[89] The Opponent also relied on Dr Pirzad’s evidence that he was unable to obtain a sample of the mycoprotein paste to support the proposition that the Applicant does not make the starting material available.[90]
[89] OS at 121 and 111-114
[90] OS at 122
However I agree with the Applicant that the Opponent has not provided any evidence that a better texturisation method was known to the Applicant at the time the application was filed (particularly because the claimed invention is vegan and the passages of the Finnigan declaration cited by the opponent relate to albumin-based products). Furthermore the best method requirement does not literally require the Applicant to make the claimed process or its starting material commercially available.
Therefore I do not find that this ground has been made out.
Manner of Manufacture
It is a well-established principle under Australian patent law that collocations of known integers with no working interrelationship between them do not constitute patentable subject matter. This was summarised in the Opponent’s submissions at 30-34 and is uncontroversial.
The Opponent pointed to Smith & Nephew[91] to support the proposition that placing an otherwise new integer in a package leads to the combination being an unpatentable collocation as there is no working interrelationship between the integer and the package.
[91] Smith & Nephew Pty Ltd v Wake Forest University Health Sciences [2009] FCAFC 142
In Smith & Nephew the court accepted that the aseptic package provided an advantage of reducing the need for the contents of the package to be sterilised but nevertheless concluded that this was unrelated to the inventive concept of the contents which was a negative pressure bandage. Therefore the court concluded there was no working interrelationship between the negative pressure bandage and the aseptic package.
At the hearing, the Applicant submitted that the feature of at least 50g of edible formulation provided in a package emphasises that the product is a processed commercial food item. The Applicant submitted that this is an artificial state of affairs, and it distinguishes the claimed formulation from unintended embodiments (such as a wild fungus, or even a cooked vegan meal where calcium may have been added in the form of tofu or nut milks).
I find the Applicant’s submissions persuasive. The present case can be distinguished from Smith & Nephew on that basis, and I further consider that the packaged form is related to the inventive concept in that the calcium is improving the properties of the Fusarium in the context of making a commercial food item. Figure 1 also shows that packaging is not the final step in the general method of production of mycoprotein containing products - a subsequent texturization step is carried out after packaging.
I also remarked during the hearing that “packaged” in this claim seems to be doing similar work to the term “isolated” in chemical or biological inventions, which is not controversial.
The Opponent also advanced a position that the claims are directed to a “mere admixture” and as such are not a manner of manufacture.[92]This is more of a potential concern under s50. The Patent Manual of Practice and Procedure does discuss admixtures but directs the examiner to either inventive step or s50.[93] I am not aware of any precedent relating to unpatentability of admixtures under the provisions of s18.
[92] OS 39
[93] See Patent Manual of Practice and Procedure at 2.9.3.2 and 2.9.2.16.3
As to whether the claims are directed to a “mere” admixture or not, I can appreciate that the “fortified Fusarium” or “tofu pie” embodiments may be simply a mixture of food ingredients which could have the potential to enliven s50.[94] However given the other findings of this decision, any action under s50 would be premature.
[94] 50 Application or grant may be refused in certain cases
The ground of lack of manner of manufacture is therefore not made out.
Utility
Although the test for utility includes the requirement that the invention have a specific, substantial and credible utility,[95] the Opponent has only pressed the ground that the claims do not achieve the benefit promised by the specification.
[95] AS at 145
It appears to be common ground that the key question is “Does the invention do what it is intended by the Applicant to do and is the end result itself useful?”[96]
[96] OS at 132-133, AS at 147
The Opponent’s substantive submissions on the application of the law to the facts were twofold: firstly that the claims include toxic Fusarium species which are not useful for consumption, and also that the claims encompass embodiments that do not have organoleptic properties that are consistent with being a meat substitute.
As to the first point, I have already found that the term “edible” imparts a requirement for non-toxicity. Therefore nothing within the scope of the claim would not be useful for consumption.
As to the second point, in making the assertion that the Applicant’s intention is to provide a meat substitute, the Opponent appears to have elided the words “particularly, but not exclusively” from p. 1 line 3. Certainly the embodiments I identified above as falling within the scope of the claim would not all satisfy as meat substitutes. However, as pointed out in the Full Court decision in ESCO[97] the specification can have multiple promises. The broadest possible promise is simply “an edible formulation comprising edible fungal particles of a filamentous fungus and calcium ions”[98] which is certainly satisfied by the claimed formulations.
[97] ESCO Corp v Ronneby Road Pty Ltd (2018) 131 IPR 1
[98] Description at p. 1 lines 31-33
I therefore find that the ground of lack of utility is not made out.
Conclusion
I have found that the Opposition succeeds on the ground of lack of inventive step (for claims 1-14, 18, and 21-29) and fails on all other grounds. Pursuant to s60(3B) I allow the Applicant a period of 60 days to propose appropriate amendments.
Since the Opposition was at least partially successful even after the Applicant amended the claims during the process, I award costs according to Schedule 8 in favour of the Opponent.
Felix White
Delegate of the Commissioner of Patents
Annex – Claims as amended
An edible formulation comprising edible fungal particles of a filamentous fungus and calcium ions, wherein said edible formulation includes 0 wt% of components derived from animals, wherein said edible formulation includes at 5 least 2,000 mg of calcium ions per Kg of filamentous fungus on a dry matter, wherein said edible formulation is provided in a package which includes at least 50 g of said edible formulation, and wherein said fungal particles comprise cells of Fusarium.
A formulation according to claim 1, wherein said edible formulation includes at least 5 wt% of said filamentous fungus on a dry matter basis.
A formulation according to claim 1 or claim 2, wherein said edible formulation includes at least 20 wt% of said filamentous fungus on a dry matter basis.
A formulation according to any one of claims 1 to 3, wherein said edible formulation includes at least 8,000 mg of calcium ions per Kg of filamentous fungus on a dry matter.
A formulation according to any one of claims 1 to 4, wherein said edible formulation includes at least 8,000 mg per Kg of filamentous fungus on a dry matter basis, of extracellular calcium ions.
A formulation according to any one of claims 1 to 5, wherein the total amount of calcium ions in said edible formulation is at least 5,000 mg per Kg, and is less than 40,000 mg per Kg of filamentous fungus.
A formulation according to any one of claims 1 to 6, wherein said edible formulation includes at least 0.100 wt% and less than 1 wt% of calcium ions in total, on a dry weight basis.
A formulation according to any one of claims 1 to 7, wherein said edible formulation includes at least 50 wt% of water.
A formulation according to any one of claims 1 to 8, wherein said edible formulation includes a polysaccharide.
10.A formulation according to any one of claims 1 to 9, wherein said edible formulation includes an alginate.
11.A formulation according to any one of claims 1 to 10, wherein 5 said edible formulation includes gluten.
12.A formulation according to any one of claims 1 to 11, wherein said edible formulation includes a protein source (A) in addition to said edible fungal particles.
13.A formulation according to claim 12, wherein said protein source (A) is a source of vegetable protein but is not a wheat-based protein.
14.A formulation according to claim 12 or claim 13, wherein said edible formulation, on a dry weight basis, includes at least 5 wt% of protein source (A), and it includes less than 20 wt% of protein source (A).
15.A formulation according to any one of claims 1 to 14, wherein said edible formulation includes acetate moieties.
16.A formulation according to any one of claims 1 to 15, wherein in said edible formulation, the ratio of the wt% of acetate ions divided by the wt% of filamentous fungus on a dry matter basis is at least 0.005 and is less than 0.04.
17.A formulation according to any one of claims 1 to 16, wherein said edible formulation includes at least 0.10 wt% and includes less than 2.00 wt% of acetate ions on a dry matter basis.
18.A formulation according to any one of claims 1 to 17, wherein said edible formulation includes:
- 5,000 mg of calcium ions per Kg of filamentous fungus on a dry matter basis;
- less than 25,000 mg of calcium ions per Kg of filamentous fungus on a dry matter basis; and
- at least 50 wt% of water.19.A formulation according to any one of claims 1 to 18, wherein in said edible formulation, the ratio of the wt% of acetate ions divided by the wt% of filamentous fungus on a dry matter basis is at least 0.005.
20.A formulation according to any one of claims 1 to 19, wherein said edible formulation includes at least 0.10 wt% and less than 1.5 wt% of acetate ions, on a dry matter basis.
21.A formulation according to any one of claims 1 to 20, wherein said fungal particles have a RNA content on a dry weight basis of less than 1.9 wt%.
22.A formulation according to any one of claims 1 to 21, wherein in said edible formulation, the ratio of the wt% of filamentous fungus (on a dry matter basis) divided by the wt% of water is at least 0.05 and said ratio is less than 0.5.
23.A formulation according to any one of claims 1 to 22, wherein said package includes at least 100 g of said edible formulation.
24.A formulation according to any one of claims 1 to 23, wherein said edible formulation is a meat substitute.
25.A formulation according to any one of claims 1 to 24, wherein said edible formulation is surrounded by packaging material which comprises a receptacle.
26.A formulation according to any one of claims 1 to 25, wherein said package includes said edible formulation and includes at least 10 g of edible fungal particles on a dry matter basis.
27.A formulation according to any one of claims 1 to 26, wherein said fungal particles comprise cells of Fusarium venenatum A3/5.
28.A method of making an edible formulation, as described in any one of claims 1 to 27, the method comprising:
(i) selecting a formulation comprising edible fungal particles of a filamentous fungus, which comprise cells of Fusarium; and
(ii) contacting said formulation with calcium ions.29.A method according to claim 28, wherein said formulation comprising edible fungal particles of a filamentous fungus comprise cells of Fusarium venenatum A3/5.
(1) The Commissioner may refuse to accept a request and specification relating to a standard patent, or to grant a standard patent:
(a) for an invention the use of which would be contrary to law; or
(b) on the ground that the specification claims as an invention:
(i) a substance that is capable of being used as food or medicine (whether for human beings or animals and whether for internal or external use) and is a mere mixture of known ingredients; or
(ii) a process producing such a substance by mere admixture.
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