Intellectual Property – Patents – Appeals from an opposition – sufficiency – enablement
Perfect Day, Inc., had a less-than-perfect day before Justice Rofe when the Commissioner of Patents stepped in after the original opponent withdrew from the appeal from a successful opposition. Justice Rofe upheld the Commissioner’s Decision that the specification was insufficient and that the claims were not supported, despite the fact that the Commissioner led no evidence, only relying on admissions made by Perfect Day in the Patent Office and cross-examination of Perfect Day’s expert.
These authors note that this judgment makes it clear that a patent that does not comply with the old law of fair basis will not comply with the new law of support. They also note that the decision demonstrates a creative approach by the Commissioner, by relying on submissions made by Perfect Day in the patent office in the context of inventive step and cross-examination rather than leading any evidence of lack of support or sufficiency.
Perfect Day was the applicant for Australian Patent Application No. 2015305271, titled “Compositions comprising a casein and methods of producing the same”.
Perfect Day appealed an opposition decision, Fonterra Co-operative Group Ltd v Perfect Day, Inc.[2022] APO 59, in which the Commissioner found that the claims of the Application lacked support, and the specification did not disclose the invention in a manner which was clear enough and complete enough for the invention to be performed by a person skilled in the art, as required by ss 40(2)(a) and 40(3) of the Patents Act 1990 (Cth). Fonterra, the successful opponent, initially filed a Notice of Contention and appeared as the respondent but later sought, and was granted, leave to withdraw.
As a consequence, the Commissioner became a party pursuant to r 34.23(2) of the Federal Court Rules 2011 (Cth), and (relatively unusually) participated in the opposition. The authors note that if the Commissioner had not actively participated, the patent application would very likely have gone through to grant: see Daiichi Sankyo Company, Limited v Alethia Biotherapeutics Inc. [2016] FCA 1540.
Perfect Day filed two interlocutory applications, both seeking to amend the Application,
during the litigation (the Amendment Applications). Perfect Day sought orders for the amendments in the second Amendment Application to be allowed, the Decision to be set aside, the opposition to be dismissed, and the amended Application to be allowed to proceed to grant. By its Amendment Applications, Perfect Day sought to narrow the claimed invention to a food composition suitable as a dairy substitute comprising two identified recombinant milk proteins, and not casein.
The Commissioner contended that the entire disclosure of the specification is directed towards a food composition that includes casein, so that the proposed amended claims to a food substitute which did not include casein lacked sufficiency and support. The Commissioner also contended that there was no support for a food composition that includes two or more characteristics of a dairy food selected from a group consisting of seventeen Listed Characteristics.
The Application
The Application was titled “Compositions comprising a casein and methods of producing the same” (although Perfect Day sought to amend the title to “Food compositions comprising milk proteins and methods of producing the same” – removing reference to “casein”). The field of the invention was dairy substitutes, methods of manufacturing the same, and compositions comprising animal-free milk fats and proteins for food applications, such as milk, butter, cheese, yogurt and cream.
The “Summary of the Invention” states that the “present invention” is based on the discovery that only a subset of components in mammal-produced milk can be used to generate a composition that has a similar flavour, a similar appearance, a similar nutritional value, a similar aroma, and a similar mouth feel of mammal-produced milk. Milk proteins include casein proteins, α-lactalbumin, β-lactoglobulin, lactoferrin, transferrin, and serum albumin.
The Application describes a number of compositions “provided” by the invention. Importantly, each comprise casein proteins.
The Application provided that, in some embodiments of the compositions described, “the composition further includes” ALA and/or BLG proteins. The Application states that “also provided are kits that include: (a) a mixture of one or more milk proteins, one or more fats, and one or more flavour compounds; and (b) a mixture of ash and at least one sweetening agent”. In some embodiments of the kits, “the one or more milk proteins are selected from the group of: β-casein, κ-casein, [ALA], [BLG] ... and serum albumin”. The Application further provides that compositions may include “one or more isolated milk protein components”. Perfect Day relied on these references as disclosing ALA and BLG proteins in a food composition, independently of casein.
The importance of casein micelles for the optimum behaviour of milk was described in the specification.
The consistory clause for claim 1 was included by way of an amendment to the specification dated 21 August 2019 (i.e., considerably after the Application was filed).
Evidence and Onus
Perfect Day contended that it did not bear the onus of proving that the Amended Application was sufficient and supported, and relied on the lack of evidence filed by the Commissioner indicating that the person skilled in the art could not have made food compositions as claimed, using the specification, without undue burden or experimentation.
The Commissioner accepted that it had the burden of establishing the grounds of opposition in the appeal proceeding, but relied on Nicholas J’s comments in ToolGen Incorporated v Fisher (No 2) [2023] FCA 794 at [19] that (emphasis added):
"Even though the burden of proof is on the respondents, circumstances may still arise in which [the patentee’s] failure to adduce any evidence or any sufficient evidence on some particular matter (eg. a fact which it asserts was common general knowledge) may ultimately lead the Court to conclude, on the totality of the relevant evidence, that the invention cannot be performed across the full scope of the claims without undue burden. This may be particularly true in relation to matters in respect of which [the document] is wholly silent".
Neither party initially sought to file evidence in the Appeal. But, after receiving the Commissioner’s submissions in answer, Perfect Day sought leave to file evidence from an independent expert witness, Professor Tong. Perfect Day filed two affidavits from Professor Tong, a Professor Emeritus at California Polytechnic State University with over 35 years of experience in dairy food science and technology. Professor Tong was cross-examined during the hearing by video. It was common ground that Professor Tong was representative of a member of a team comprised of persons skilled in the art (PSA).
The Commissioner cautioned against accepting what it described as Perfect Day’s “unsupported assertions of fact”, and submissions based on the extensive expert evidence before the Delegate of the Commissioner in the opposition proceedings, which had not been read into evidence before the Court. Since none of that evidence was before Justice Rofe in this appeal, the Commissioner submitted, and Justice Rofe accepted, that any evidence or submissions based on the evidence before the Delegate should be disregarded.
The Commissioner sought to tender certain paragraphs from submissions filed on behalf of Perfect Day in the opposition proceedings as admissions regarding what was, and was not, common general knowledge (CGK) as at the priority date. Perfect Day did not object to the Commissioner’s reliance on these paragraphs but disputed the conclusions the Commissioner sought to draw from them.
Common General Knowledge
Perfect Day admitted that it was CGK at the priority date that it was not obvious, and there was no reasonable expectation, that a subset of proteins of mammal produced milk, namely ALA and BLG proteins expressed in fungal systems, could be used to generate a dairy substitute food composition. It also admitted that it was not CGK at the priority date that isolated milk proteins (including ALA and BLG proteins) could be used as ingredients to make dairy substitute food compositions.
The Commissioner noted that Perfect Day had previously acknowledged in its written submissions before the Delegate that, at the priority date, it was CGK that isolating native ALA and BLG proteins was both difficult and costly. These proteins were typically purified from milk for research purposes rather than for food production. Additionally, it was widely accepted that casein was an essential component of dairy products, contributing to their structure and functional properties.
Professor Tong’s cross-examination disclosed that the PSA would not have had experience with milks that lacked casein, nor would they have encountered a synthetic milk product or produced a recombinant milk containing only ALA and BLG proteins (or recombinant versions thereof) without any other milk proteins. Moreover, the PSA would recognise that casein micelles play a crucial role in the behaviour of milk across various applications. Finally, the PSA would have considered that the challenges involved in replicating all the characteristics of milk are “tremendous”.
Claim Construction
Claim 1 of the Amended Application claims a food composition suitable as a dairy substitute which has “one or more” characteristics of a dairy food selected from the group consisting of the seventeen Listed Characteristics. Professor Tong explained that the Listed Characteristics were an exhaustive list of characteristics which included physical properties, sensory properties and properties which could be measured in a laboratory by analytical techniques.
An issue emerged during the hearing as to the phrase “one or more” used in relation to the Listed Characteristics, and whether the claim covered a food composition suitable as a dairy substitute that had: (1) one of the Listed Characteristics; (2) more than one of the Listed Characteristics; or (3) all of the Listed Characteristics.
Perfect Day contended that claim 1 claims a food composition that has one of the Listed Characteristics, not a food composition having all the Listed Characteristics or even a minimum number of Listed Characteristics. The Commissioner propounded a broader construction in which the claim encompasses a food composition with one Listed Characteristic, more than one Listed Characteristic or all the Listed Characteristics. Justice Rofe accepted the Commissioner’s construction.
Support – section 40(3)
The Commissioner submitted that the claimed invention lacks support on two bases.
First, the Commissioner contended that the body of the specification does not support the claims to food compositions comprising BLG and ALA proteins and no other milk proteins. The Commissioner said that the invention, as defined in the claims, is fundamentally different from the invention disclosed in the body of the specification and there is no enabling disclosure as to how to make such food compositions, such that the invention as claimed is not supported by the technical contribution to the art.
Second, the Commissioner contended that the technical contribution of the invention described in the specification did not support the scope of the invention claimed because there is no support in the specification for a food composition which has more than one, or all of the Listed Characteristics.
A composition with BLG and ALA and no other proteins was not supported
Perfect Day submitted that the invention claimed is not “fundamentally different from the invention disclosed in the body of the specification”, that there were a number of inventions or aspects thereof described, not all of which are claimed, and that it was legitimate to have claims far narrower than the description in the specification. Perfect Day relied on the consistory clause, corresponding to claim 1, and the references in the Application summarised above.
As to whether there was a basis in the description for each claim, her Honour noted (by reference to Lockwood Security Products Pty Limited v Doric Products Pty Limited [2004] HCA 58; (2004) 217 CLR 274 at [69] and [91]) that the intention of the Raising the Bar Act was to “raise the bar” on patentability, and that it would be a strange result if a claim that would not be fairly based prior to the implementation of the Raising the Bar Act could satisfy the support requirement following its introduction through coincidence of language with a consistory clause which is inconsistent with the disclosure in the specification as a whole.
Her Honour considered that, putting aside the Listed Characteristics, the invention claimed is a food composition that comprises ALA and BLG proteins as the only milk proteins and does not include casein (or any other milk proteins), and that this was a different invention to the invention disclosed in the specification, when read as a whole, which describes a food composition that includes casein and may further include other milk proteins, and methods of making them.
Save for the consistory clause (and its corresponding claim), there is no mention in the Application of a food composition that is suitable as a dairy substitute comprising BLG and ALA and no other milk proteins, nor any description of making such a food composition. Her Honour did not accept that the passages relied upon by Perfect Day conveyed an inferential disclosure of a composition comprising ALA and BLG with no other milk proteins, given the extensive specification which describes compositions and provides examples which all include casein. Her Honour concluded that the selected phrases relied upon by Perfect Day to support the invention claimed in claim 1 were no more than loose or stray remarks, and that the invention claimed in claim 1 is a different invention to that described in the specification when read as a whole, and was therefore not supported.
The claims went beyond the technical contribution
Perfect Day submitted that the Listed Characteristics did not go to the essence of the invention. The claimed dairy substitute food composition does not have to be a good dairy substitute, and might only have one of the Listed Characteristics. It said the combination of all the Listed Characteristics went beyond what it asserted as being the essence of the invention.
Perfect Day contended that it would be possible to redraft claim 1 into 16 different claims that each claimed a food composition consisting of ALA and BLG and no other milk proteins, with one of the Listed Characteristics, and that each of these claims would be enabled, demonstrating that finding claim 1 to be not supported (or insufficient) would be a triumph of form over substance.
Justice Rofe rejected that submission on the basis that each of the sixteen putative claims would define a different invention from the one currently claimed, because splitting the claims would remove any claim to a food composition comprising combinations of more than one, or all of the Listed Characteristics. Her Honour concluded that claim 1 claimed, at its broadest, the combination of all the Listed Characteristics. That is what had to be supported by the disclosure in the specification.
Her Honour also considered that, in the case of a product, the contribution to the art is the product which is enabled to be made by the disclosure (citing Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] UKSC 27; [2020] RPC 22 at [56], [58]). Professor Tong’s evidence made it clear that a composition with all of the Listed Characteristics exceeded the technical contribution the Application makes, and the challenges of recreating at least all of the Listed Characteristics of animal-free milk were “tremendous”. Her Honour concluded that, against the background of the CGK, it was not plausible that the invention claimed in claim 1 could be worked across the full scope of the claim, without undue burden, as required.
Her Honour therefore concluded that claim 1 of the Amended Application lacked support.
Sufficiency – section 40(2)(a)
The Commissioner made two sufficiency arguments. First, the invention claimed— a dairy substitute food composition which excludes casein — was not disclosed in the specification when read as a whole. Second, the specification did not give the PSA meaningful assistance about how to produce the claimed products, particularly where the claimed products include combinations of the Listed Characteristics. At best, the Application provided a “starting point” from which the PSA is left to rely on their common general knowledge alone.
Her Honour agreed with the Commissioner’s first argument: that the invention disclosed in the specification when read as a whole is different to the invention claimed in claim 1. The authors note that the sufficiency requirement in section 40(2)(a) of the Patents Act is concerned with the specification as a whole, including the claims (unlike the support requirement in section 40(3) which compares the claims to the rest of the patent specification). Arguably, given that fact, the invention disclosed in the specification cannot be different to the claimed invention because the specification includes the claims. However, her Honour may have been treating the claim as going no higher than a consistory clause for the purposes of sufficiency, which itself cannot provide disclosure, if it is contrary to the remainder of the specification.
In relation to the second argument, her Honour concluded (by reference to Nicholas J’s comments at [192]-[193] of ToolGen in relation to the priority date requirement), that it is not sufficient for the specification to provide a starting point from which the PSA may transition from one invention to another by the use of CGK. The mere fact that it would be obvious to the PSA to use the disclosure in the specification to produce what is claimed is not enough if, properly characterised, the disclosure in the specification and the claim are for different inventions: ToolGen at [193]. The authors query if this is correct, since the test for priority date in ToolGen appeared to suggest that, as is the case in the UK, there is a requirement in the UK that the priority document disclose the “same invention”, and there is not an explicit “same invention” requirement for sufficiency in section 40(2)(a) of the Act. Priority date is concerned with a comparison between the invention claimed in each claim and the whole priority document and according to ToolGen, involves a question of whether the invention as claimed is disclosed in the priority document and, separately, whether the claimed invention is enabled by the priority document. The former question, according to her Honour and Nicholas J in ToolGen, does not permit the application of CGK whereas the latter, enablement, does. The authors also note that for enablement in section 40(2)(a), the PSA can use CGK to assist. Perhaps Rofe J, like Nicholas J in ToolGen in relation to s 43(2A), saw work to do for the word “disclose” in s 40(2)(a), independently of the enablement requirement. This might come as no surprise, given her Honour was a member of the Full Court in Glass Hardware v TCT Group Pty Ltd [2024] FCAFC 95, which held at [79] that “the disclosure requirements for external and internal sufficiency are the same” but which made no express mention of any “same invention” requirement in s 43(2A) or s 40(2)(a).
Professor Tong’s evidence was that his “starting point” in making a milk substitute composition was simply replacing the casein (and presumably all other milk proteins) from an example of the Application with recombinant ALA and recombinant BLG proteins. He agreed that he could not predict the properties of the composition in advance. It was apparent from Professor Tong’s evidence that issues might arise during the conduct of the trials and studies that would be required and that the difficulties encountered were likely to vary depending on the intended dairy substitute product.
Her Honour concluded that the Application provided no guidance to the PSA seeking to perform the invention by making a dairy substitute composition with two or more of the Listed Characteristics, and that the PSA would need to undertake a process of prolonged testing, enquiry and experiment requiring inventive skill or ingenuity or undue effort.
Accordingly, her Honour concluded claim 1 also lacked sufficiency.
For these reasons, the Court concluded that the claims of the Application, even as amended, lacked support and the specification failed to disclose the invention in a manner which was clear enough and complete enough for the invention to be performed by a PSA, and therefore should not proceed to grant.
