Marlow Foods Limited v The Fynder Group, Inc - [2023] APO 18

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Marlow Foods Limited v The Fynder Group, Inc. [2023] APO 18

Patent Application: 2017227612

Title:Filamentous fungal biomats, methods of their production and methods of their use

Patent Applicant:                   The Fynder Group, Inc.
Opponent:  Marlow Foods Limited
Delegate:  Dr A. Lim
Decision Date:  4 April 2023
Hearing Date:  15 February 2023, via video conference

Catchwords: PATENTS – section 59 – opposition to the grant of a patent – amendments filed during opposition – it has not been established that any of the claims fail to comply with the grounds of manner of manufacture, novelty, inventive step, utility, sufficiency, disclosure of best method, support, and clarity – opposition unsuccessful – split award of costs

Representation: Counsel for the applicant: Mr Ben Fitzpatrick
Patent attorney for the applicant: Mr Mark O’ Donnell and Dr Michael Dow from Madderns Pty Ltd
No written submissions were filed by the opponent.

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2017227612

Title:Filamentous fungal biomats, methods of their production and methods of their use

Patent Applicant: The Fynder Group, Inc.
Date of Decision: 4 April 2023
DECISION
The opposition is unsuccessful.
The opponent has not established that claims 1-39 fail to comply with the grounds of manner of manufacture, novelty, inventive step, utility, sufficiency, disclosure of best method, support, and clarity.
Subject to appeal, I direct the application to proceed to grant.
I award costs according to schedule 8 of the Patents Regulations 1991 incurred before 7 September 2022 against the applicant, The Fynder Group, Inc. I award costs according to schedule 8 incurred after 7 September 2022 against the opponent, Marlow Foods Limited.
REASONS FOR DECISION
Background

Patent application 2017227612 (the opposed application) was filed on 28 February 2017 under the provisions of the Patent Cooperation Treaty. The applicant at the time of filing the opposed application was Sustainable Bioproducts Holdings, LLC. Sustainable Bioproducts Holdings, LLC subsequently changed its name to The Fynder Group Inc. A request to change the name of the applicant for the opposed application, and certificate of change of name, were filed by The Fynder Group Inc (the applicant) on 25 September 2020. The opposed application claims priority from three US provisional applications and the earliest filing date of these applications is 1 March 2016.[1]
[1] The three US provisional applications from which the opposed application, 2017227612, claims priority are US 62/302,123 having a filing date of 1 March 2016, US 62/340,381 having a filing date of 23 May 2016, and US 62/345,973 having a filing date of 6 June 2016.
The opposed application was examined and advertised accepted by the Commissioner on 13 May 2021. Marlow Foods Limited (the opponent) served a notice of opposition on 13 August 2021 and filed a statement of grounds and particulars (SGP) on 15 November 2021.
Evidence in support (EIS) was filed by the opponent on 14 February 2022. Evidence in answer (EIA) was filed by the applicant on 17 May 2022, along with a request to make voluntary amendments to the description and claims of the opposed application. Leave to amend the specification was granted and details of the request to amend were subsequently advertised on 30 June 2022 for opposition purposes. The opponent advised on 15 July 2022 it would not file Evidence in Reply. On 26 August 2022, the opponent also advised the Commissioner it did not wish to attend an oral hearing set for the opposition and requested the opposition be decided on the evidence as filed.
No opposition was filed regarding the applicant’s amendments of 17 May 2022. The amendments were allowed on 7 September 2022, the applicant was notified of the allowance on the same day, and allowance of the amendments was published on 22 September 2022. However, an excess claim fee which applied to the request to amend the specification had not been paid before allowance of the amendments. The excess claim fee was due within two months after the date on which the notice to grant of leave is published, that is, by 30 August 2022.[2] As the applicant paid the excess claim fee on 15 September 2022, regulation 22.2EA determined that the request for leave to amend the complete specification was taken not to have been filed. Therefore, allowance of the amendments on 7 September 2022 was ultra vires. This unfortunate situation was not identified by the Commissioner until January 2023. On 17 January 2023 a delegate of the Commissioner wrote to the parties to explain the situation and allowed time for the parties to respond.
[2] Patents Regulations (1991), regulation 22.2EA.
On 19 January 2023, the applicant filed a request for an extension of time under s 223(2)(a). The applicant also filed a declaration that it was always the intention of the applicant to pay the excess claims fee and an error was made that caused the due date for payment to be missed. The delegate of the Commissioner assessed the extension of time to be allowable and invited comments from the opponent. The opponent chose not to comment, and the extension of time was allowed on 3 February 2023. On the same day, the applicant’s amendments of 17 May 2022 were properly allowed within the legislative requirements and incorporated into the specification. Consequently, the applicant’s amendments of 17 May 2022 form part of the specification and the opposition proceeds in respect of the amended claims.
The opponent chose not to make any submissions for the hearing. The applicant accordingly directed its submissions to the grounds of opposition identified in the SGP and I will decide the opposition as particularised. This approach is somewhat complicated by the fact that the claims have been amended quite significantly and the opponent’s evidence and particulars are not directed to the claims in their present form. In any event, subsequent references to the opponent’s allegations relate to those made in the SGP.
The opposition
The grounds of opposition stated in the SGP are:
·claimed invention is not for a manner of manufacture,
·lack of novelty.
·lack of inventive step,
·lack of utility,
·lack of a clear enough and complete enough disclosure in the specification,
·no disclosure of the best method,
·lack of support, and
·lack of clarity
The opponent also alleged that the unamended claims of the opposed application are not entitled to claim an earlier priority date from any of the three US provisional applications I mentioned above. This is because the opponent alleged these provisional applications do not disclose the claimed invention in a manner that is clear enough and complete enough.[3] I will discuss the issue of priority date later in my decision.
[3] The SGP dated 15 November 2021 at section 2.
The evidence is summarised in the table below.

Evidence Declarant Exhibits Date Reference

In Support Douglas Bruce Kell DBK-1 to DBK-20 10 February 2022 Kell

In Answer Phillip T Olson PO-1 to PO-9 16 May 2022 Olson

Mark A Kozubal MAK-1 12 May 2022 Kozubal

There are a total of 7 documents which the opponent alleged were relevant to the current opposition.[4]
[4] These documents were filed together with the SGP on 15 November 2021.
Since the opposed application was filed on 28 February 2017, this application is governed by the Patents Act 1990 (the Act) as amended by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012. This includes subsection 60(3A) of the Act which states:
(3A) If the Commissioner is satisfied, on the balance of probabilities, that a ground of opposition to the grant of the standard patent exists, the Commissioner may refuse the application.
The standard of proof that applies to the present opposition is the balance of probabilities, and the opponent carries the onus of proof.
The specification
The field of the invention relates to isolated filamentous fungi strains within several species, methods of conducting surface fermentation to produce filamentous fungi biomats from the fungal strains and use of filamentous fungi to produce useful products including a foodstuff. The filamentous fungi strains mentioned are Ascomycota, Zygomycota, Basidiomycota, Glomermycota, and Chytridiomycota phyla, such as Fusarium species, Aspergillus species, Tricoderma species, Penicillium species, species within the order Mucorales, including Rhizopus species, the acidophilic filamentous fungal strain designated as MK7 and their progeny.[5]
[5] The specification at [1], [5].
Copies of Budapest Treaty deposit receipts for MK7 have been filed in support of the opposed application. The receipt stated that MK7, identified as a Fusarium oxysporum, was deposited on 2 March 2010 in the American Type Culture Collection (ATCC®) and the patent deposit designation is PTA-10698. The ATCC® accession deposit reference is cited in the specification.[6]
[6] The specification at [10A], [10D], [84] and [105].
The specification as amended up to this point in time has 39 claims. Claims 1, 23 and 39 are the independent claims. The claim set is reproduced in Annex A of this decision. I have inserted emphasis (underlining) in Annex A to indicate features of the claims that were added by the amendments of 17 May 2022. I note Annex A does not show text deleted by the amendments.
Principles of construction
Before commencing to construe the specification, I note what Middleton J said in Eli Lilly and Company Limited v Apotex Pty Ltd:
“It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date.”[7]
[7] [2013] FCA 214 at [139]; 100 IPR 451.
The person skilled in the art (PSA)
It is well established that many of the issues in an opposition are answered by reference to the PSA:
“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.”[8]
[8] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70]; 177 ALR 231.
However, the PSA is an artificial construct that is used as a tool of analysis, and there is a danger in trying to identify them as an actual person or persons:
“The notional person is not an avatar for expert witnesses whose testimony is accepted by the court. It is a pale shadow of a real person – a tool of analysis which guides the court in determining, by reference to expert and other evidence, whether an invention as claimed does not involve an inventive step.”[9]
[9] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23]; 89 ALJR 798.
An understanding of the PSA is based on evidence from persons with knowledge of the art as to the things that they know and do, and what they understand to be commonly known and done. The qualifications of the expert witnesses, relevant to the present opposition, are summarised below.
Professor Douglas Bruce Kell has many years’ academic experience and has worked in fermentation, biotechnology, pharmaceutical, machine learning and related industries in various roles. Professor Kell is also an inventor of a biomass sensor and founding director of Aber Instruments which markets the biomass sensor to the fermentation industry.[10]
[10] Kell at [2], [5]; Exhibit DBK-1.
Mr Phillip Olson has many years’ research experience in microbial fermentation. He has worked in various roles in Bio-Technical Resources (BTR), Manitowec, Wisconsin, which is a specialist fermentation company that develops new strains and processes for making products based on microbial fermentation. Mr Olson has managed approximately 40 different types of fermentation and downstream recovery processes involving bacteria, yeast, and fungi. He regularly reviews and reads scientific papers relating to fermentation, particularly fungal fermentation.[11]
[11] Olson at [6]-[8]; Exhibit PO-1.
Dr Mark Kozubal is named as a co-inventor on the opposed application. Dr Kozubal is a co-founder and Chief Science Officer of the applicant. He has skills in the field of producing filamentous fungal material, with expertise in the growth of filamentous fungal biomats by surface fermentation.[12]
[12] Kozubal at [1]-[2].
I consider all the declarants mentioned above are able to provide evidence as to what the PSA knew and would have done. The weighing and evaluating of the evidence to decide the characteristics of the PSA is part of the normal work of a delegate of the Commissioner.
The background to the invention
The cells of most fungi are described to grow as tubular, elongated and thread-like structures called hyphae. Hyphae grow at their tips and the growth process leads to the development of a collection of the hyphae termed a mycelium. The mycelium is viewed as the main form of the fungus and the fungus is often described as being filamentous.[13] I understand fungi which can develop mycelia to be characterised as filamentous fungi.
[13] The specification at [2]-[3].
The specification states that the Ascomycota and Zygomycota phyla of the Fungi kingdom, particularly, have many filamentous species and members of these phyla make many products such as proteins, oils, medicines (e.g., penicillin), food (e.g., tempeh), food preservatives (e.g., citric acid) as well as being used to make cheese, wine, and beer.[14]
[14] The specification at [5].
The specification states that “[s]tate of the art solid-substrate fermentation (SSF) suffers from several disadvantages”. [15] The disadvantages include:
[15] The specification at [6].
·the fungal biomass, being the final product, and the solid substrate are intimately mixed and, therefore, difficult to separate from each other,
·low yield of fungal biomass,
·difficulties and high costs of implementing and maintaining the right amount of water activity for effective fermentation,
·improper water activity and poor aeration resulting in overheating and deficient oxygen supply, and
·the resulting biomass, characterised as having randomly orientated filaments, being of limited utility in certain applications, e.g., food or animal feed.[16]
[16] Ibid.
SSF is used in the specification to refer to both solid-substrate fermentation and solid-state fermentation.[17] Given the context in which SSF is used in the specification, I consider it is reasonable to interpret that the terms solid-state fermentation and solid-substrate fermentation are used interchangeably. Solid-state fermentation is used to refer to microbial fermentation that occurs on solids at low water content, typically below 50%.[18] The microorganism is grown on a solid support, such as rice or wheat bran, with low water levels. The solid support is described to be saturated with water, but little of it is free flowing.[19]
[17] The specification at [6], [28], [202]-[204], [208].
[18] The specification at [202].
[19] The specification at [73].
The term “biomass” is used in the specification to refer to biological material derived from living or recently living organisms, e.g., stems, leaves, materials derived from algae or animals or industrial by-products and waste streams.[20]
[20] The specification at [54].
Another state-of-the-art fermentation method described in the specification is submerged fermentation.[21] Submerged fermentation is used in the specification to refer to fermentation where the microorganisms utilised grow in a submerged state within fermentation media.[22] This method is described as a batch-based continuous process that uses costly bioreactors. Separation of the fungal biomass from the fermentation liquid also requires centrifugation which is described as a capital intensive and energy demanding process. The biomass produced is characterised as having short filaments and therefore limited in ability to directly convert to food or feed products without introducing binding agents and subsequent process steps which incur additional costs and effort to manage.[23] I understand submerged fermentation to be a form of liquid-state fermentation.[24] Quorn™, a product comprised primarily of a biomass of Fusarium venenatum, is described as produced by submerged fermentation.
[21] The specification at [7].
[22] The specification at [72].
[23] The specification at [7].
[24] Kell at [24].
The specification states that “there is a need in the industry for a streamlined approach to filamentous mycelia filamentous fungi biomat formation”.[25]
[25] The specification at [9].
Aim of the invention
The specification states:
“The current disclosure has been developed in view of the limitation of the processes currently used. Here, filamentous fungi biomats are generated via surface fermentation after inoculation of the desired fungal strain into a novel growth media where no aeration is required. This method of surface fermentation is applicable to a large variety of fungal species which are able to produce a wide assortment of products across a spectrum of different industries. The media developed desirably generates rapid cell growth, creates high density filamentous fungi biomats with long filaments, produces small waste streams, and allows engineering of the filamentous fungi biomat produced as a function of carbon source, carbon to nitrogen ratio (C:N), and process parameters. The desirable overall effect is one in which high production rates occur with minimal environmental impact as measured by water usage, energy usage, equipment requirements, and carbon footprint.”[26]
[26] The specification at [10].
I infer the aim of the invention is to provide an alternative method of producing filamentous mycelia from filamentous fungi, in the form of a biomat.
The invention as described in the specification
The specification describes several aspects of the invention, and each aspect generally mirrors an independent claim in the claim set (as amended on 17 May 2022) of the present application. A first aspect is a filamentous fungal biomat described as having a thickness of 1 mm to 30 mm and comprises at least two structurally different cell layers in contact with each other. These cell layers include an aerial hyphae layer and a bottom layer in contact with an artificial medium. The aerial hyphae layer is less dense than the bottom layer. The biomat has a cell density of at least 30 g dry weight/L media and sufficient tensile strength and structural integrity to be handled without tearing. The biomat is produced by a surface fermentation method which comprises
(i)growing the filamentous fungi on the surface of an aqueous media in an undisturbed state to a cell density of at least 30 g dry weight /L media, wherein the aqueous media comprises nutrients in dissolved or submerged form comprising a carbon source supporting aerial hyphae formation and a carbon to nitrogen ratio (C:N) of 7.5:1 or less supporting production of protein in the biomat; and
(ii)harvesting the filamentous fungal biomat by a process comprising inactivation of viability, deactivation of enzymes or a combination thereof. [27]
[27] The specification at [10A].
The ratio of thickness of the bottom layer of the biomat to the thickness the upper aerial hyphae layer of the biomat may be at least 0.41.[28] In certain embodiments, the tensile strength of the biomat is at least 0.2 kg/cm of mat width.[29] In some embodiments, the biomat has an average filament length of between 0.05 cm and 2 cm.[30]
[28] The specification at [10Ai].
[29] The specification at [10Aiv].
[30] The specification at [10Av].

In some embodiments, the filamentous fungi are selected from the group consisting of Fusarium, Fusisporium, Pseudofusarium, Gibberella, Sporotrichella, Aspergillus, Penicillium, Trichoderma, species within the order Mucorales, the filamentous fungal strain designated as MK7, yeasts capable of producing filaments, and combinations thereof. In other embodiments, the filamentous fungi are selected from a group consisting of a Fusarium species and a Rhizopus species. In certain embodiments, the filamentous fungi are selected from a group consisting of the strain designated as MK7 (ATCC Accession Deposit No. PTA-10698), Fusarium venenatum and Rhizopus oligosporus.[31]
[31] The specification at [10Aii].
In some embodiments, the biomat comprises amino acids selected from one or more of the essential amino acids which are produced by the filamentous fungi. In other embodiments, the biomat comprises all the essential amino acids. In certain embodiments, the biomat comprises protein comprising about 20% branched chain amino acids.[32] The biomat disclosed in the specification is described as a food product which may be a human food, fish feed or animal feed.[33]
[32] The specification at [10Avi].
[33] The specification at [10B].
A second aspect of the invention described is a method of producing a filamentous fungal biomat suitable for use in a food product by a surface fermentation method. The surface fermentation method described for the second aspect comprises inoculating an effective amount of at least one filamentous fungus into an aqueous artificial growth media, incubating the inoculated growth media in an undisturbed state by surface fermentation to produce a filamentous fungal biomat of a cell density of at least 30 g dry weight/L media, and harvesting the filamentous fungal biomat by a process comprising inactivation of viability, deactivation of enzymes or a combination thereof. The content of the growth media described for the second aspect is the same as that described for the first aspect and supports production of protein content. The biomat harvested has a cell density of at least 30 g dry weight/L media and is 1 mm to 30 mm thick.[34]
[34] The specification at [10C].
The third aspect of the invention described is a method of removing carbon and nitrogen from feedlot lagoon water comprising: (a) adjusting the lagoon water to a pH 2.6; (b) inoculating the adjusted lagoon water with strain MK7 (ATCC Accession Deposit No. PTA-10698); and (c) producing a filamentous fungi biomat on the surface of the lagoon; wherein the biomat contains the carbon and nitrogen removed from the lagoon water.[35]
[35] The specification at [10D].
The specification defines the meaning of several terms, and it is useful to provide the definitions of some of these terms here.
Filamentous fungi biomat
The terms “filamentous fungi biomat” and “filamentous biomat” are used interchangeably in the specification and refer to biomats produced by, and containing, filamentous fungi.[36] The biomats are described as being produced by solid-substrate surface fermentation.[37]
[36] The specification at [56].
[37] The specification at [78].
Fermentation
The specification uses the term “fermentation” or “fermentation process” to refer to a process in which an organism or biocatalyst is cultivated in a culture medium containing raw materials, such as a carbon source and nutrients, wherein the organism or biocatalyst converts those raw materials into products.[38]
[38] The specification at [53]
Surface fermentation
Surface fermentation refers to those fermentations in which the microorganisms employed grow on the surface of the fermentation media without any further support. The media is described as typically a free-flowing media. The specification suggests, without being bound by theory, that filamentous biomats result from some combination of aerobic, microaerobic and/or anaerobic metabolism. For example, the surface of the biomat is thought to rely on aerobic respiration while the bottom of the biomat may be microaerobic to highly anaerobic.[39]
[39] The specification at [70].
Solid substrate surface fermentation
Solid substrate surface fermentation (SSSF) refers to those fermentations in which the microorganisms employed grow on the surface of the fermentation media using carbon and nutrients supplied by solids that are submerged in the fermentation media. The specification explains that in some embodiments, some portion of the biomat may be partially submerged.[40]
[40] The specification at [71].
The specification also explains that extracellular enzymes excreted from the fungus degrade the solid carbon substrate, releasing soluble carbon that can be taken up by the biomat at or near the biomat/water surface. The liquid layer above the submerged carbon source is generally about 0.01-1.0 cm deep. If there is too little liquid, there is no mat formation and solid-state fermentation and/or submerged fermentation results. If there is too much liquid, the result is inefficient substrate conversion to filamentous biomat and a depressed biomat growth cycle.[41]
[41] The specification at [78].
Carbon source
The specification uses the term “carbon source” to refer to a substance suitable to be used as a source of carbon for prokaryotic or eukaryotic cell growth. Carbon sources include carbohydrates (e.g., starch, sucrose, polysaccharides, and monosaccharides), whey, acid whey, glycerol, lignocellulosic feedstock and/or combinations thereof.[42]
[42] The specification at [10Ci], [51].
Feedstock
The specification uses the term “feedstock” to refer to any renewable, biological material that can be used directly as a fuel or converted to another form of fuel or energy product. Biomass feedstocks are described as the plant and algal materials used to derive fuels like ethanol, butanol, biodiesel, and other hydrocarbon fuels.[43]
[43] The specification at [36].
Lignocellulosic feedstock
The term “lignocellulosic feedstock” is used to refer to feedstocks containing lignocellulose. Examples of lignocellulose feedstock include agricultural crop residues (e.g., wheat straw, barley straw, rice straw, small grain straw, corn stover), corn fibres, corn steep liquor, beet pulp and a combination thereof.[44]
[44] The specification at [37].
Artificial media for growth of filamentous fungi biomat
The specification describes an artificial media is used to produce a filamentous fungal biomat. The artificial media provides the nutrients required for increased growth rates as compared to those found in nature and results in increased cell density. The artificial media is described to comprise at least nitrogen (N), phosphorus (P), calcium (Ca), magnesium (Mg), carbon (C), potassium (K) and sulphur (S). Trace nutrients such as iron, boron, chromium, copper, selenium, manganese, molybdenum, vanadium, and zinc can be added to the media to supplement carbon sources.[45]
[45] The specification at [76].
The carbon to nitrogen ratio (C:N) within the artificial media can be manipulated to significantly influence the composition of the biomat produced by the fungal species or strain(s). A low C:N ratio, such as a C:N ratio of 7.5:1 or less, favours production of amino acids and proteins as compared to lipids. A C:N ratio of more than 7.5:1 favours production of lipids as compared to proteins. Lipid production is particularly favoured when the artificial media has a C:N ratio of 10:1, 15:1, 20:1, 26:1, 30:1, 40:1 or 50:1.[46]
[46] The specification at [82].
The pH of the artificial media is determined based on the products desired, and the fungal species or strain(s) employed. For Fusisporium, Pseudofusarium, Gibberella, Sporotrichella, Aspergillus, Penicillium, Triocoderma, species within the order Mucorales sp. (e.g., Rhizopus sp.), the isolated filamentous acidophilic fungal strain designated as MK7, and combinations thereof, high lipid production takes place over pH 2.0-7.0 and optimally at a pH of less than 3.5. High protein production, while predominantly influenced as a function of C:N ratios, is described to require a pH of at least 2.7 and preferably a pH between 4.5 and 5.5.[47]
[47] The specification at [83].
Cultures and compositions comprising isolated fungal species or strains
The specification describes that the culture used for the invention can be a pure culture of an isolated fungal species or strain, a pure co-culture of two fungal species or strains, or a substantially pure culture of three or more fungal species or strains.[48] As previously mentioned a large number of isolated filamentous fungal species or strains can be used. Many of the examples of the opposed application, which I will discuss shortly, use the isolated filamentous acidophilic fungal strain designated as MK7 (ATCC Accession Deposit No. PTA-10698). However, the specification also describes the use of Rhizopus oligosporus and Fusarium venenatum to form biomats.[49]
[48] The specification at [84].
[49] The specification at [26], [27], [198]-[201], Example 17, Figures 12 and 13.
The filamentous acidophilic MK7 fungal strain is described as a new strain of acidophilic fungus which can directly convert carbon sources such as lignocellulose carbon sources, carbohydrates, acid whey, and algal biomass into filamentous fungi biomats comprising protein and lipids.[50]
[50] The specification at [85].
Filamentous fungi biomat grown by surface fermentation
The specification describes that surface fermentation is initiated by inoculating artificial media with inoculum culture at a concentration that will produce a mature mat in the desired period. Typically, inoculation with 0.5-1.0 g of cells per litre of growth media will produce a biomat in 3 to 6 days. No external oxygen is introduced to the artificial media by bubbling or other means, sufficient oxygen can be gathered from ambient or near ambient conditions.[51]
[51] The specification at [91].
The specification states:
“Without being bound by theory, it is thought that because cell growth is much more rapid in the presence of oxygen, conidia present at the surface of the artificial media where more oxygen is present will grow rapidly and begin formation of the mycelial biomat. It is believed that oxygen concentrations are much lower only a few micrometers below the surface of the artificial media and consequently would place fungal cells located in those regions in a stress environment. Stress is known to increase excretion of extracellular polysaccharides, which have a ‘sticky’ phenotype, and would thus aid in the rapid formation of the filamentous fungi biomat by adhering to the cells proliferating at the surface. Substrate concentration, however, also has a significant effect. For example, when the carbon substrate concentration is below 4%, filamentous fungi biomats will not form. It should be noted that initial environmental stress to form mats does not necessarily infer that a stressed mat, i.e. a mat containing toxins excreted by the stressed organism is formed.”[52]
[52] The specification at [92].
The specification explains that shallow trays containing artificial media are used for surface fermentation under controlled conditions of temperature, humidity, and airflow suitable for the fungal species or strain(s) employed. Sufficient airflow is maintained to remove heat and carbon dioxide produced from microbial respiration and supply oxygen without agitating the surface of the artificial media and disrupting fungal hyphae growth.[53]
[53] The specification at [93].
The specification describes:
“In general, a ‘skin’ begins to form on the surface of the artificial media on day 2 after inoculation. This ‘skin’ is the initial filamentous fungi biomat which frequently includes aerial hyphae as well as hyphae in contact with the artificial media and which continues to grow and increase in cell density. Typically, three to six days after inoculation, the resultant filamentous fungi biomats are 1 to 30 mm thick and have sufficient tensile strength and structural integrity to be handled without tearing.”[54]
[54] The specification at [94].
The biomats formed using the methods of the opposed application are described to have a significantly greater cell density than those found in nature. The specification describes that the produced filamentous fungi biomat is very dense, typically 50-200 g/L. The produced filamentous fungi biomat is described to commonly have 5-20% solids. In contrast, filamentous fungi produced by natural and submerged processes commonly result in biomass densities of about 15 g/L and less than 1.5% solids.[55]
[55] The specification at [96].
The specification describes several characteristics of the filamentous fungi biomat produced by the methods of the present invention which distinguish the produced filamentous biomat from naturally formed filamentous fungi biomat.[56] Firstly, naturally formed filamentous fungi biomats are not composed of a pure culture, co-culture or substantially pure culture but typically contain algae or bacteria in addition to a filamentous fungal species.[57]
[56] The specification at [95]-[98].
[57] The specification at [95].
Secondly, the filamentous biomats produced by the methods of the opposed application have a significantly greater cell density than those found in nature. The specification states:
“One result of the densities achieved, the filamentous nature, and the extracellular matrix found in these dense biomats is an ability to be maintained as a cohesive mat upon drying. This is in stark contrast to the powdery and/or non-cohesive form normally found with other dried filamentous fungi biomats.”[58]
[58] The specification at [96].
Thirdly, the “biomats formed using the methods and techniques described herein have a high tensile strength compared to naturally occurring biomats, allowing them to be lifted and moved without breakage.”[59]
[59] The specification at [97].
Fourthly, the produced filamentous fungi biomats are described to have a defined structure. In some embodiments, the defined structure comprises at least two different layers: (a) a dense bottom layer and (b) an aerial hyphae layer. The aerial hyphae layer is described to be significantly less dense than the bottom layer of the biomat. The aerial hyphae are predominantly oriented perpendicular to the biomat-air or biomat-media interface. The dense layer comprises long filaments which are aligned parallel with the biomat-air or biomat-media interface. The resulting biomat of the preferred embodiment has essentially pure fungal biomass.[60]
[60] The specification at [98].
The specification suggests that the aerial hyphae accelerate growth of the biomat as disruptions to the aerial hyphae layer negatively impact the growth of the biomat. Disruptions include contact with a solid object, contact with water droplets, and fissures caused from agitation of the liquid media upon which the biomat grows. Typically, no further growth occurs in the disrupted biomat area when the cause of disruption is removed.[61] The specification postulates that aerial hyphae and mycelia play an important role in supplying oxygen for the respiration of cells in the entire biomat.[62]
[61] The specification at [100].
[62] The specification at [156], [172].
Acidophilic fungal species or strains are described to be capable of rapid, high density cell growth under the culturing conditions. The cell densities that can be achieved by these microorganisms include at least 30g/L media and higher.[63] The growth of the acidophilic fungal species can be further increased by adjusting the fermentation conditions. For example, the temperature, pH, concentration of ions, time of incubation or gas concentration can be adjusted.[64]
[63] The specification at [110].
[64] The specification at [111].
Harvesting of the biomats is described to normally occur between day 3 and day 12 after inoculation, depending on the species or strains used and the product desired, although later harvest times are also possible. The methods used in harvesting include rinsing, inactivation of viability procedures and physical processing (e.g., size reduction, pressure treatment, dehydration). In some embodiments, the filamentous fungi biomats are harvested, rinsed with water, and either dried at a temperature-controlled oven to deactivate any of the enzymes and limit biochemical transformation within the biomat, or frozen.[65]
[65] The specification at [101].
Examples in the specification
The 27 examples and 18 figures of the specification describe various aspects of the invention. I will discuss some of the examples as these explain the nature of the invention.
Example 2 describes the preparation of the artificial media MK7-1 and MK7-3. The ingredients of MK7-1 liquid medium with glycerol as the carbon source are listed in Table 1A.[66] The MK7-1 liquid medium of Table 1A is described to have 75g/L glycerol (equivalent to 7.5% glycerol content) with a C:N ratio of 7.5:1.[67] Another MK7-1 liquid medium, termed “modified MK7-1” and described in Table 2, has glucose (125 g/L) as the carbon source and also a C:N ratio of 7.5:1.[68] Both types of MK7-1 media produced high-density filamentous fungi biomats by surface fermentation.[69]
[66] The specification at pages 40-41.
[67] The specification at [18].
[68] The specification at [160].
[69] The specification at [[150]-[154], [160].
Example 3 describes the process of preparing an inoculum of filamentous acidophilic MK7 fungal strain in a 10 L reactor.[70] The inoculum is subsequently used in Example 4 to inoculate trays where growth of MK7 by surface fermentation produces filamentous fungi biomats.[71] For use as inoculum in the trays, the culture cell density in the 10 L reactor should be above 6 g/L dry weight and in late exponential growth phase, that is just prior to cessation of exponential growth when the cell growth rates begin to decline. Lower cell densities are described to result in significantly slower biomat formation and are undesirable.[72] The specification explains that dry filamentous biomass is measured by collecting a sample of the liquid culture from the 10L reactor, filtering a known volume through a 0.22 µm filter using a vacuum filter apparatus, drying the wet filamentous biomass at 50^oC for 4h and then determining the weight of the dried filamentous biomass.[73]
[70] The specification at [139]-[145]
[71] The specification at [146]-[157].
[72] The specification at [142]-[143].
[73] The specification at [142].
Example 4 describes the dimensions of trays that are used for growing MK7 by surface fermentation. However, the specification notes that different tray sizes can be used. A commercially available rack system is used to hold the trays and clear plastic (Saran®-like wrap) was used to wrap and enclose the rack system and isolate the trays from the surrounding room. This enabled control of humidity and airflow and minimised contamination. Humidified sterile air was blown into the enclosed rack at a rate of 800ml/minute via bubbling through 200 ml deionised water (18.2 Mohm), which had a water temperature 22-30^oC, and passage of the air through an autoclaved 0.2µm filter to remove microorganisms.[74]
[74] The specification at [147].
The specification explains that airflow should be such that it flushes out carbon dioxide and excess heat produced by fungal cell respiration and supply adequate oxygen to the respiring cells. However, airflow should not be strong enough to perturb the fungal hyphae and inhibit their growth and function.[75] The temperature of the tray system ranged from 25^oC ± 2^oC during growth.[76] The specification also describes the amount of the inoculum (prepared in Example 3) that is added to the MK7-1 medium for rapid growth of fungal cells and mat formation.[77]
[75] The specification at [148].
[76] The specification at [149].
[77] The specification at [150].
After 6 days incubation, the resultant biomats were 3 to 10 mm thick with enough tensile strength and structural integrity so that they could be handled without tearing. The biomats were removed from the trays by hand, rinsed with water and dried or frozen. For drying, the biomats were placed in a temperature-controlled oven and heated to 60^o ± 1^o C for 45 minutes to deactivate many of the enzymes and limit biochemical transformations within the mat, followed by heating at 50^o ± 1^o C for approximately 48-72 h until the dry weight did not change.[78]
[78] The specification at [153].

The specification describes that the typical growth pattern for MK7 in shallow trays show an initial lag phase where biomass accumulation rates are relatively slow, followed by an exponential growth phase.[79] The specification explains:
[79] The specification at [21], Figure 7.
“Cells grow in a planktonic (homogenous/evenly distributed cells throughout the medium) state until about 48 hours of growth. After 48 hours, the cells aggregate at the surface of the medium and begin to form a biofilm; in other words, a microbial mat where cells are intertwined and stuck together. The mat is a very thin skin at first, but continues to grow rapidly until some limiting factor such as lack carbon substrate or other nutrient limits growth.”[80] (emphasis added)
[80] The specification at [154].
The specification also explains that it is important that the trays remain undisturbed and the integrity of the biomat is maintained during the entire growth period. Disturbances result in loss of the advantages of rapid growth rates and high filamentous biomass accumulation per liquid volume and surface area.[81]
[81] The specification at [155].
Example 8 describes the use of transmitted light microscopy and cryosectioning to determine the structure of a biomat produced from MK7 grown on MK7-1 medium with 7.5% glycerol.[82] As discussed above, this medium has a C:N ratio of 7.5:1.[83] The biomats were observed to have a visibly dominant aerial hyphae layer, followed by a dense bottom layer. In some samples, a transition zone layer is visible between the aerial hyphae layer and the dense bottom layer.[84] The visible ratio of the (a) dense bottom layer to the (b) aerial hyphae layer to the (c) transition zone layer is about 3.68 to about 9.43 to about 1.[85]
[82] The specification at [169]-[170].
[83] The specification at [18].
[84] The specification at Figures 10A and 10B.
[85] The specification at [171].
Example 9 describes the evaluation of the tensile strength of the biomat. One end of the mat was clamped into a stationary position while the other end was clamped to a free moving apparatus. The free moving apparatus was itself attached to a scale that measures applied tension. A steady and slow tension was applied to the mat by pulling on the scale over several seconds until the mat broke. For a biomat grown on MK7-3 medium with glycerol as a carbon source, the average tensile strength was 0.2 kg/cm mat width.[86]
[86] The specification at [177]-[178]. The ingredients of MK7-3 are listed in Table 1B, page 41 of the specification.
Examples 10, 11, 12, 14, 15 and 20 describe the growth of MK7 biomats on different feedstock (for example, corn steep liquor and acid whey) as a replacement for MK7-1 nutrients. Filamentous fungi biomats are produced in each example.[87]
[87] The specification at [[179]-[185], [188]-[197], [215]-[239].
Example 17 evaluates the growth of two different filamentous fungi, Rhizopus oligosporus and Fusarium venenatum, using the surface fermentation techniques described in Examples 2 and 3 for MK7.[88] Rhizopus oligosporus is used for Tempeh production. Tempeh is an Asian food made from soybeans fermented with Rhizopus oligosporus or R. oryzae fungus which incorporates the soybeans in the product as residual material in what is essentially a solid substrate fermentation.[89] Fusarium venenatum is used in Quorn™ food production.[90]
[88] The specification at [198]-[201].
[89] Olson at [30].
[90] The specification at [200].
Rhizopus oligosporus strain ATCC 22595, obtained from the ATCC, was grown in MK7-1 medium at pH 4.1 with 5% glycerol.[91] The specification explains that Fusarium venenatum was culled from a Quorn Chik’n Nuggets package purchased from a supermarket.[92] The isolated Fusarium venenatum was grown in MK7-1 medium at pH 5.0 and 12.5% glycerol.[93] Images of biomats formed after 6 days of growth are shown in Figures 12 and 13 of the specification. The figures also show images of the hyphae in the mats using light microscopy.
[91] The specification at [26], [199].
[92] The specification at [200].
[93] The specification at [27], [200]-[201].
Example 18 compares biomass produced by solid substrate surface fermentation (SSSF) with that produced by solid state fermentation (SSF).[94] The key differences in the SSSF and SSF methodologies are summarised in Table 6 of the specification which is reproduced here.
[94] The specification at [202]-[209].

SSF SSSF

Density (g dry weight strain MK7 biomass/kg of medium: substrate mixture) <5 120-180

Tensile Strength Not measurable
Wet biomass: 0.05-0.24 kg/com width, average ~0.009 kg/com width. Dry biomass (no subsequent processing): 2-6 kg/com width, average -3 kg/com

width

Osmotic pressure of medium

(atm)
3.4 18.6

Ionic strength of medium

(molar)
0.077 0.368

Cell type used for inoculum Stationary phase filamentous cells (i.e. cells> 100 μm in length) Late exponential phase
planktonic cells (i.e. cells <20 μm in length)

Lignocellulose in medium

(%)
>25 2.5-25

Average filament length 0.001-0.02 cm 0.05-2 cm

Filament orientation Random Parallel

Final composition (%) Less than 5% fungi Grater than 95% fungi

Final biomat consistency Fragile, not cohesive,
heterogeneous
Robust, cohesive,

Homogenous

Example 25 describes an evaluation of the amino acid profile of filamentous biomass from a biomat produced by the acidophilic MK7 fungal strain using the method described in Examples 2 and 3 in MK7-1 medium. Amino acids were analysed using internationally recognised published methods. The amino acid composition of the sample from the MK7 fungal strain was compared with published amino acid compositions of Fusarium venenatum used for fish food, egg albumin and Rhizopus oligosporus.[95] The results of the comparative analyses, showing amino acid concentration as a percent of total amino acids, are summarised in Table 8 of the specification, and reproduced below. The total protein concentration of the MK7 fungal strain sample was measured as 41.5% of a 4.5% moisture content biomass. The MK7 fungal strain had a higher concentration of essential amino acid (denoted with an asterisk) compared to all of the four other protein sources.[96]
[95] The specification at [243]-[244].
[96] The specification at [243].
Example 27 describes toxicity analyses of strain MK7. Five samples of strain MK7 grown under different conditions were assayed for the presence of mycotoxins. The different conditions relate to glycerol content, C:N ratio, pH, and peptone supplement. Mycotoxins were extracted from wet biomass using a commercially available assay kit and analysed by chromatography methods.[97] The measured values for all toxins tested were below the regulatory levels for human consumption set by the U.S. Food and Drug Administration.[98] The non-toxic character of MK7 culture medium and biomass was further verified by bioassays with Daphnia magna, a highly sensitive macroinvertebrate commonly used for toxicity assays. No significant differences in survival rates were observed between D. magna treated with MK7 culture medium and biomass, and the experimental controls.[99] The toxicity of the MK7 biomass was additionally tested on Goldfish (Carassius auratus). Goldfish were fed daily with dried MK7 biomass, as produced by the method described in Example 3, or a control fish feed. All Goldfish survived and appeared healthy, vigorously swimming, after 60 days of feeding.[100]
[97] The specification at [253]-[258].
[98] The specification at [259]-[260], Table 11.
[99] The specification at [261].
[100] The specification at [262].
Example 13 describes growth of filamentous fungi biomats using cattle feedlot lagoon water as the sole carbon and nutrient source. The initial dissolved organic carbon content of the waters was 4 g/L and initial total dissolved nitrogen content was 0.8 g/L. Feedlot lagoon water was adjusted to pH 2.6 with concentrated HCl and inoculated with a 7% MK7 strain inoculum as prepared in Example 3. Sterilised trays were filled with the inoculated wastewater and incubated in a tray rack system at 24^o±1^oC. Two days after inoculation, filamentous fungi biomats began to form on the surface of the liquid. After 10 days, the filamentous fungi biomats and remaining liquid were collected and dried prior to analysis for total C and N. Analyses of the mats and residual liquid revealed that about 77% of the carbon and 99-100% of the nitrogen were removed from the feedlot lagoon wastewater by the mats. Carbon and nitrogen removal rates for the system were 6.8 and 1.2 mg/L/h when averaged over the 10-day period.[101]
[101] The specification at [186]-[187].
Priority date
The opponent alleged that the unamended claims are not entitled to the mentioned priority dates of the US provisional applications.[102] The applicant noted the opponent adduced no evidence to support this allegation against the unamended claims, let alone the amended claims.[103]
[102] The SGP dated 15 November 2021 at section 2.
[103] The applicant’s written submissions filed 8 February 2023 at [60].
The applicant also noted that, even if the opposed application is not entitled to an earliest priority date of 1 March 2016, the only prior art document that becomes available for the purposes of assessment for the novelty and inventive step requirements is the journal article, published in March 2016, entitled “Screening and optimization of some inorganic salts for the production of ergot alkaloids from Penicillium species using surface culture fermentation process” (herein referred to as D1).[104] The applicant has argued that the amended claims are clearly novel and inventive over D1 and consequently nothing turns on D1 qualifying as prior art if the asserted priority date is not maintained.[105] For reasons I will discuss shortly, I agree with the applicant that, even if D1 is part of the prior art base, the amended claims do not fail for lack of novelty or inventive step when assessed against D1.
[104] The citation details of D1 are Pak. J. Pharm. Sci, Vol.29, No.2, March 2016, pp 407-414. A copy of D1 was filed on 15 November 2021 as part of the SGP mentioned documents.
[105] The applicant’s written submissions filed 8 February 2023 at [61].
It is arguable whether US 62/302,123 (the priority document of the opposed application having the earliest filing date of 1 March 2016) discloses all the features of the biomat claimed in the amended claims in a clear enough and complete enough manner. For example, while US 62/302,123 discloses a biomat having a thickness of 3 to 10 mm, the document does not explicitly disclose a biomat thickness of 1 to 30 mm.[106] There appears to be no evidence or submissions on whether there is implicit disclosure of this feature in US 62/302,123. Since nothing turns on D1 qualifying as prior art if the asserted priority date is not maintained, I do not need to decide whether the claims are entitled to claim priority from US 62/302,123.
[106] US 62/302,123 at [89], [136].
Common general knowledge (CGK)
Before construing the claims, it is helpful to review what was already known in the art before the earliest priority date, 1 March 2016, in the field of filamentous fungi, fermentation processes for producing filamentous fungi and the use of filamentous fungi as a foodstuff.
The opponent’s expert witness, Professor Kell, made statements in evidence regarding what was already known in the art as of 1 March 2016.[107] Professor Kell was advised by the opponent’s representatives to assume 1 March 2016 as the earliest claimed priority for the opposed application, but that the priority date was a matter at issue in the opposition, and that the relevant priority date may be later, and could be as late as 28 February 2017.[108] While Professor Kell was also advised to indicate if there were material changes in what was commonly known between 1 March 2016 and 28 February 2017, I note there appears no such indication in his declaration. I consider it is reasonable to infer that the CGK did not relevantly change between 1 March 2016 and 28 February 2017.
[107] Kell at [15].
[108] Kell at [12].
CGK is the background knowledge and experience available to all those working in the relevant art:
“The notion of common general knowledge itself involves the use of that which is known or used by those in the relevant trade. It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge.”[109]
[109] Minnesota Mining and Manufacturing Co v Beiersdorf (Aust) Ltd [1980] HCA 9 at [115]; 144 CLR 253 at page 292.
The CGK is not limited to knowledge which the PSA might have memorised but also includes information which the skilled person knows exists and would have referred to as a matter of course. Emmett J stated:
“The common general knowledge is the technical background to the hypothetical skilled worker in the relevant art. It is not limited to material which might be memorised and retained at the front of the skilled workers mind but also includes material in the field in which he is working which he knows exists and to which he would refer as a matter of course. It might, for example, include:
·     standard texts and handbooks;
·     standard English dictionaries;
·     technical dictionaries relevant to the field;
·     magazines and other publications specific to the field.”[110]
[110] ICI Chemicals & Polymers Ltd v Lubrizol Corp Inc [1999] FCA 345; 45 IPR 577 at [112].
However, it is not enough that information is recorded in a document, even if that document is widely circulated − it is only part of the CGK when it is generally known and accepted. Middleton J stated:
“… information does not constitute common general knowledge merely because it might be found, for example, in a journal, even if widely read by persons in the art … Reference in this regard is made to the words of Luxmoore J in British Acoustic Films (1936) 53 RPC 221 at 250, cited by Lehane J in Aktiebolaget Hässle v Alphapharm Pty Ltd (1999) 44 IPR 593; [1999] FCA 628 at 605 [39]:
In my judgment it is not sufficient to prove common general knowledge that a particular disclosure is made in an article, or series of articles, in a scientific journal, no matter how wide the circulation of that journal may be, in the absence of any evidence that the disclosure is accepted generally by those who are engaged in the art to which the disclosure relates. A piece of particular knowledge as disclosed in a scientific paper does not become common general knowledge merely because it is widely read, and still less because it is widely circulated. Such a piece of knowledge only becomes general knowledge when it is generally known and accepted without question by the bulk of those who are engaged in the particular art; in other words, when it becomes part of their common stock of knowledge relating to the art.”[111]
[111] Ranbaxy Laboratories Limited v AstraZeneca AB [2013] FCA 368; 101 IPR 11 at [217].
Professor Kell summarised a list of what he believes to be the CGK in his declaration.[112] The applicant’s expert witness, Mr Olson, disagreed with some of the items in Professor Kell’s list.[113] Having read the statements of the experts witnesses of both parties, I consider it is reasonable to conclude that there is general agreement between the experts that the following forms part of the CGK as of 1 March 2016:
[112] Kell at [71].
[113] Olson at [13]-[16].
·It is well known to produce fungal biomass or mycelia by fermentation.
·There is a very large number of fungal species which may be fermented to produce fungal biomass.
·There are a range of different types of fermentation processes including solid state fermentations (where fermentation is undertaken on a solid which has suitable water content) and liquid state fermentation (where fermentation is undertaken in or on a liquid).
Professor Kell explained that liquid state fermentation may involve surface fermentation where fungal mycelium forms and floats on a surface of a liquid which contains nutrients, or may involve submerged fermentation where mycelium forms within a nutrient-containing liquid.[114] A well-known process of liquid state fermentation is that used by the opponent to produce the mycoprotein sold under Quorn™.[115] I understand the production of Quorn™ involves a liquid submerged fermentation process where fermentation is undertaken in the liquid.
[114] Kell at [22].
[115] Kell at [24]-[25].
Professor Kell also stated that liquid surface fermentation is a well-known liquid state fermentation process. He described the production of penicillin using shallow containers, around the time of the Second World War, to be a form of liquid surface fermentation. [116] Professor Kell also described the production of citric acid by Aspergillus niger to involve liquid surface fermentation.[117] He further described the penicillin and citric acid fermentations to form fungal biomass, in the form of a mat, which floats on the surface of the nutrient-containing liquid.[118]
[116] Kell at [26]-[30].
[117] Kell at [29].
[118] Kell at [30].
Mr Olson stated that the early processes for producing penicillin and citric acid using fungi fermentation in shallow containers result in the generation of a surface-residing layer of fungal biomass that may be aptly described as a “mat” or “biomat”, but which does not have the characteristics and features of the biomat mentioned in the opposed application.[119] I understand Mr Olson’s statements to mean the fungal biomass which forms on the surface of the liquid during fungi fermentation, using shallow trays, for producing penicillin and citric acid is not a thick and cohesive mat of filamentous fungi that has sufficient tensile strength to be handled without tearing.
[119] Olson at [17], [23].
Mr Olson cites two journal articles in support of his expectation that a fungal mat produced from the early fermentation processes, using shallow trays, is not thick and cohesive.[120] The Holtman article discloses production of penicillin using a surface culture technique. The article notes that it was sometimes difficult to produce a continuous growth of mould over the entire surface of the medium and that corn oil and lanolin were used in attempts to improve the uniformity.[121] The article also discusses how, at the time of writing, production of penicillin by submerged culture was an important commercial method.[122] The Currie article (filed with Professor Kell’s declaration) discloses the production of citric acid using a surface culture technique and discusses how the mycelium floats on the surface of the substrate but wrinkles in such a manner that presents an enormous surface of contact, and the wrinkled structures often project 5 to 6 cm into the substrate.[123]
[120] Holtman, D.F., Antibiotic products of Fungi, The Botanical Review XIII(2), February 1947, pp59-91 (Holtman article), filed as Exhibit PO-3; Currie, J.N., The citric acid fermentation of Aspergillus niger, J. Bio. Chem. 31:15-37, 20 April 1917 (Currie article), filed as Exhibit DBK8.
[121] Holtman article at page 74.
[122] Holtman article at page 70.
[123] Currie article at page 17, Figure 5.
The Holtman article describes that penicillin is extracted from the fermentation medium by filtering off the biomass.[124] The Currie article describes citric acid is extracted from the fermentation medium by pressing the biomass.[125] The Currie article also discusses that the conditions most favourable for a high yield of end products (i.e., mycelia) are least favourable for the formation of the intermediate product (i.e., citric acid).[126] Mr Olson stated that he understood the reverse to be true; that is, that conditions most favourable for the production of citric acid (or penicillin) are least favourable for a high yield of fungal biomass. In his declaration, Mr Olson referred to intermediate products as metabolites or secondary metabolites.[127]
[124] Holtman article at page 72.
[125] Currie article at page 36.
[126] Currie article at page 22.
[127] Olson at [21], [34].

I consider the early methods of liquid surface fermentation using shallow trays discussed above were for the purposes of obtaining secondary metabolites (citric acid and penicillin) which were extracted from the fermentation medium. The purpose of these early methods was not to produce a mycelial biomat. Additionally, I consider the evidence of Professor Kell does not clearly indicate that the structure of the fungal biomass produced by the early methods was thick and cohesive to form a mycelial biomat that has sufficient tensile strength to be handled without tearing.[128]
[128] Kell at [30].
The invention as claimed and clarity
The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd. (Lundbeck):
“the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear … while the claims define the monopoly claimed in the words of the patentee's choosing, the specification should be read as a whole … it is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification … terms in the claim which are unclear may be defined or clarified by reference to the body of the specification”[129]
It is a requirement of subsection 40(3) of the Act that the claims must be clear. As stated by the court in Flexible Steel Lacing Company v Beltreco Ltd., and cited with approval in Austral Ships Sales Pty Ltd v Stena Rederi Aktiebolag:
“…Lack of precise definition in claims is not fatal to their validity, so long as they provide a workable standard suitable to their intended use. The consideration is whether, on any reasonable view, the claim has meaning. In determining this, the expression in question must be understood in a practical, commonsense manner. Absurd constructions should be avoided and mere technicalities should not defeat the grant of protection.”[130]
A claim will lack clarity if a third party could not ascertain whether a proposed action would fall within the ambit of the claim.[131]
Claim 1
[129] [2009] FCAFC 70 at [118] – [120]; 81 IPR 228.
[130] [2000] FCA 890 at [81]; 49 IPR 331. Cited with approval in [2008] FCAFC 121; 77 IPR 229.
[131] Monsanto Co v Commissioner of Patents (1974) 48ALJR 59.

100. It is convenient to parse claim 1, the first independent claim of the opposed application (as amended), as done in the applicant’s written submissions. I reproduce claim 1 as parsed here.[132]
[132] The applicant’s submissions filed 8 February 2023 at [37].
a) A filamentous fungal biomat comprising a filamentous fungi;
b) wherein the biomat: is of a thickness of 1 mm to 30 mm and comprises at least two structurally different cell layers in contact with each other, comprising an aerial hyphae layer and a bottom mycelium layer;
c) wherein the aerial hyphae layer is;
d) less dense than the bottom mycelium layer;
e) has a cell density of at least 30 g dry weight /L media;
f) has sufficient tensile strength and structural integrity to be handled without tearing; and
g) is produced by a surface fermentation method, said method comprising:
h) growing the filamentous fungi on the surface of an aqueous media in an undisturbed state to a cell density of at least 30 g dry weight /L media, wherein the aqueous media comprises nutrients in dissolved or submerged form comprising a carbon source supporting aerial hyphae formation and a carbon to nitrogen ratio (C:N) of 7.5:1 or less supporting production of protein in the biomat; and
i) harvesting the filamentous fungal biomat by a process comprising inactivation of viability, deactivation of enzymes or a combination thereof.

101. I will now consider the meaning of several terms in claim 1.
filamentous fungal biomat comprising a filamentous fungi
102. The opponent alleged the term “biomat” is not considered a recognised term in the art and lacks clarity.[133] The applicant submitted:
“… the term ‘biomat’… is an entirely apt term for the relatively thick and cohesive mats of filamentous fungi described in the Opposed Application. Paragraph [154] of the Opposed Application describes the formation of a biomat and refers to a ‘microbial mat’, and the description of the structure of ‘biomats’ produced by strain MK7 at Example 8. The PSA would understand the term as referring to a relatively thick layer of mycelial mass that may be formed on the surface of liquid media by liquid surface fermentation”[134]
[133] The SGP dated 15 November 2021 at section 3.
[134] The applicant’s submissions filed 8 February 2023 at [245] citing Olson at [37].

103. Paragraph [154] of the opposed application describes that “[a]fter 48 hours, the [fungal] cells aggregate at the surface of the medium and begin to form a biofilm; in other words, a microbial mat where cells are intertwined and stuck together. The mat is a very thin skin at first, but continues to grow rapidly until some limiting factor such as lack carbon substrate or other nutrient limits growth.”
104. I consider “biomat” is a term which the PSA would understand in the context of the description in the specification and agree with the applicant’s submissions. From the plain meaning of the words and their arrangement in the context of the whole claim, it is clear a “biomat” of claim 1 means a mat produced by a biological method using a fungus that can develop mycelia (filamentous fungi) and a surface formation method which has the steps defined in integers (h) and (i). As described previously, the growth conditions and composition of the aqueous media used for the surface fermentation method (and defined in claim 1) result in the production of filamentous fungal biomat with a particular structure on the surface of the aqueous media. The structure of the filamentous fungal biomat is also defined by the integers of claim 1. I consider the term “biomat” is clear to the PSA.
the biomat: is of a thickness of 1 mm to 30 mm
105. The opponent alleged that it is unclear if the biomat has a thickness in the range 1 mm to 30 mm across its entire extent, or if the biomat has a single thickness value which is constant and with the mentioned range across its entire extent, or if the average thickness across the entire biomat is within the mentioned range.[135]
[135] The SGP dated 15 November 2021 at section 3.
106. I consider the plain meaning of the words to be that that the overall thickness of the biomat is 1 mm to 30 mm. To the extent that there is ambiguity regarding the uniformity of the thickness of the biomat, reference can be made to the specification. Mr Olson analysed this point using the specification and I agree with his analyses. He stated:
“If I look in the Accepted Application, I note that the liquid medium in the tray is undisturbed and certainly flat, so it is reasonable to assume that the biomat is also flat. Indeed, the mats shown in Figure 1C and Figure 6 of the Accepted Application appear to be substantially uniform and flat. This is reflected in the uniform edge of the rolled up biomat depicted in Figure 1D. I have noted that biomats produced under different conditions can be of different thickness as described in the Examples (see Example 11, paragraph [182] and paragraph [183]; where Treatment 1 produced a mat with a thickness of 2.7 mm and Treatment 2 produced a mat thickness of 6.4 mm). Accordingly, I understand that the biomat defined in claim I has a thickness (of 1 mm to 30 mm) which is substantially uniform across its dimensions.”[136]
[136] Olson at [40].

107. I consider the terms defining the thickness of the biomat to be clear.
biomat…has a cell density of at least 30 g dry weight /L media
108. The opponent alleged that it is unclear if the cell density is different from the density of the biomat. The opponent also appears to be alleging it is unclear how cell density, expressed as dry weight/L media, is measured. [137]
[137] The SGP dated 15 November 2021 at section 3.
109. A perusal of the specification reveals “cell density” is expressed as dry weight per litre media (g dry weight/L) and is explained as the amount of dry filamentous fungi that can be produced per litre of media.[138] Example 4 describes the use of 1.5 L of growth media to culture fungal cells and after 6 days of growth the resulting mats were rinsed in water, dried, and heated in an oven to deactivate enzymes and limit biochemical transformations within the mat. The average dry weight of the biomats was 81 g filamentous biomass per tray, which is described as equivalent to a cell density of 54 g /L.[139] In the context of the words of claim 1 and a reading of the whole specification, I consider it is clear “cell density” refers to the dry weight of the filamentous fungi produced per litre of media.
sufficient tensile strength and structural integrity to be handled without tearing
[138] The specification at [110], [111], [143], [153].
[139] The specification at [153].
110. The meaning of the words is evident and mean that the structure of the filamentous fungal biomat provides sufficient strength and integrity such that when handled the biomat does not tear.
harvesting the filamentous fungal biomat by a process comprising inactivation of viability, deactivation of enzymes or a combination thereof
111. The plain meaning of the words indicates that the harvesting process inactivates the viability of microorganisms, deactivates enzymes, or both. As previously discussed, the specification describes that the practical effect of these processes, such as heating or drying, is limiting biochemical transformations within the mat.[140]
Claims 2-22
[140] The specification at [101], [153].
112. The appended claims 2-20 define further features of the filamentous fungal biomat. Claim 21 defines “[a] food product, comprising the biomat defined in any one of the preceding claims.” Claim 22 further defines the food product of claim 21.

113. I have discussed the different features that are defined in the appended claims when discussing the invention as described in the specification. The opponent alleged unamended claims 6, 7, 12-14 and 17 are not clear.[141] The allegations generally relate to units of measurement which are now part of amended claims 4, 9-11 and 14.[142]
[141] The SGP dated 15 November 2021 at section 3.
[142] Unamended claim 7 has been deleted from the claim set as amended on 17 May 2022.

114. Claim 4 (as amended) defines the protein content of the biomat as a percentage. The opponent alleged that the protein content percentage is unclear because no unit is defined. A reference to the specification clarifies that this percentage is calculated as a proportion by weight of the dried biomat.[143] Mr Olson also states this to be his interpretation.[144] I consider the scope of claim 4 to be clear.
[143] The specification at [243] which states “ [t]he total protein content was measured as 41.5% of a 4.5% moisture content biomass.”
[144] Olson at [45].

115. Claim 9 (as amended) defines the biomat as comprising between 5% and 20% solids. The opponent alleged that it is unclear how these percentages are calculated. I consider the PSA would understand how these percentages are calculated. Mr Olson stated that determining the solid content is easy and involves weighing the wet biomat, followed by drying the biomat, and then weighing the dried biomat again. The difference in weight gives the solid content which is expressed as a percentage. Mr Olson also stated that it is customary to describe percentage solids as grams of solids per 100 grams of material; in this case, 5-20 g solids per 100 grams of biomat.[145] I consider the scope of claim 9 to be clear.
[145] Olson at [47].

116. Claim 10 (as amended) defines the tensile strength of the biomat to be at least 0.2 kg/cm of the mat width. The opponent alleged that the claim is unclear because the method of how to define the parameter is not defined. I interpret claim 10 to define a particular value of a tensile strength of a biomat that is within the scope of “sufficient tensile strength ….to be handled without tearing”. A reference to Example 9 in the specification clarifies one method of measuring tensile strength. I have previously discussed this example. I consider the scope of claim 10 to be clear.

117. Claim 11 (as amended) defines the biomat to have an average filament length of between 0.05 cm and 2 cm. The opponent alleged the claim is unclear because the method of how to measure this property is not defined. It is evident to me that claim 11 is defining what the average filament length in the biomat is. I also consider the PSA would understand how filament length is measured. Mr Olson stated that this measurement is easy to do and performed with a microscope stage micrometer.[146] I consider the scope of claim 11 is clear.
[146] Olson at [49].

118. Claim 14 (as amended) defines the biomat to comprise protein comprising about 20% branched chain amino acids. The opponent alleged the claim is unclear as no unit is defined. A reference to Table 8 in the specification clarifies amino acid concentration to be expressed as a percentage of total amino acids.[147] I understand this to mean that, if there are 20 branched chain amino acids in a 100 amino acid protein, there is 20% branched chain amino acids. I consider the scope of claim 14 is clear.
Claim 23
[147] The specification at [244]. Table 8 has also been reproduced in this decision.
119. Independent claim 23 is directed to a method of producing a filamentous fungal biomat by a surface fermentation method suitable for use in a food product. Claim 23 is reproduced in full in Annex A. In short, aqueous artificial growth media inoculated with at least one filamentous fungi is incubated in an undisturbed state to produce a filamentous fungal biomat by surface fermentation. The growth conditions, artificial media, and structure of the biomat formed is defined in claim 23 in the same terms as that used in claim 1. The filamentous fungi biomat is harvested by a process comprising inactivation of viability, deactivation of enzymes or a combination thereof. As with my consideration of claim 1, claim 23 is clear.
Claims 24-38
120. The appended claims 24-38 define further features of the method of claim 23. I have discussed many of the further features defined in these claims when I discussed the invention as described. I consider the terms used to define the further features of claims 24-38 are readily understood using the plain meaning of the terms or by the PSA.
Claim 39
121. Independent claim 39 (reproduced in Annex A) is directed to a method of removing carbon and nitrogen from feedlot lagoon water. The method uses the specific and deposited filamentous fungal strain MK7. I consider the terms used in claim 39 would be readily understood using the plain meaning of the terms.
122. I conclude that the opponent has not established that any one of the claims of the opposed application lacks clarity.
Clear enough and complete enough disclosure (Sufficiency)
123. Section 40(2)(a) of the Act requires that the complete specification must disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art.
124. In CSR Building Products Limited v United States Gypsum Company (CSR), a Deputy Commissioner determined that the steps involved in assessing whether the disclosure requirement is satisfied are:
(i) Construe the claims to determine the scope of the invention as claimed;
(ii) Construe the description to determine what it discloses to the person skilled in the art; and
[148] [2015] APO 72 at [95]Cytec at [143].
(iii) Decide whether the specification provides an enabling disclosure of all the things that fall within the scope of the claims.”[148]

125. In Evolva SA [2017] APO 57 (Evolva), another Deputy Commissioner reformulated the third question stated in CSR as a two-step consideration:
(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?[149]
[149] [2017] APO 57 Cytec at [144].

126. The approaches taken in CSR and Evolva have found approval with the Federal Court in Cytec Industries Inc. v Nalco Company (Cytec).[150]
The opponent’s allegations
[150] [2021] FCA 970 at [143]-[149]; 162 IPR 202.
127. The opponent contended that the specification does not comply with s 40(2)(a) because it did not disclose the alleged invention in a manner that is clear enough and complete enough to be performed by the PSA across the full scope as claimed in any of the unamended claims 1-34 without undue experimentation. The underlying basis for the opponent’s allegations under this ground is that the art is so complex and unpredictable that, despite the description of invention in the opposed application, the skilled reader would be unable to perform the methodology taught.[151] The applicant noted that these allegations stand in stark contrast to the Opponent’s assertions as to the CGK of the PSA and the opponent’s pleading in relation to inventive step.[152] The applicant, therefore, submitted the opponent’s pleadings in relation to s 40(2)(a) need to be understood in the context of the opponent’s own allegations about the CGK and what the PSA is asserted to understand about the art.
[151] The SGP dated 15 November 2021 at section 9.
[152] The applicant’s submissions filed 8 February 2023 at [182].
128. Regarding the PSA, the opponent alleged that “a skilled addressee looking to produce a filamentous fungal material has knowledge of how to prepare and manufacture various filamentous fungal materials. The skilled addressee would also have knowledge of the properties of various filamentous fungal materials, methods of preparation and modification of properties.”[153]
[153] The SGP dated 15 November 2021 at section 7.1.
129. The opponent also alleged that:
“[t]he common general knowledge of a person skilled in the art at the relevant priority date may comprise:
i.various fermentation methods are routinely used to produce filamentous fungal materials such as mycelial mats;
ii.various media including aqueous media are routinely used and adjusted to develop and produce filamentous fungal materials including mats;
iii.filamentous fungus materials are routinely used in a range of applications including food products.”[154]
[154] The SGP dated 15 November 2021 at section 7.2.

What is the invention as claimed? What does the specification disclose?
130. I have previously discussed the invention as claimed and as described. In summary, the specification discloses a growth media that is described to generate rapid cell growth, create high density filamentous fungi biomats with long filaments, and allows engineering of the filamentous fungi biomat produced as a function of carbon source, C:N, and process parameters. The growth conditions described allow fungal cells to grow by surface fermentation in an undisturbed state to a high cell density (at least 30 dry weight/L), producing a biomat having structurally different layers with sufficient tensile strength and structural integrity to be handled without tearing. Relevantly, the results of the growth conditions and media are the high cell densities achieved, the filamentous nature of the biomat and presence of an extracellular matrix (extracellular polysaccharides with a ‘sticky’ phenotype) found in the bottom mycelium layer. These features are described to provide the biomat with an ability to be maintained as a cohesive mat upon drying.
Is it plausible to obtain the filamentous fungal biomat defined in claim 1 by following the teachings of the specification?
131. A significant question regarding sufficiency of disclosure is whether the opposed application provides clear guidance telling the skilled person how to obtain a filamentous fungal biomat that falls within the scope of claim 1 (as amended) from any species or strains of filamentous fungi.

[216] US 5,854,056 (D2) at column 11.
[217] US 5,854,056 (D2) at column 7 and 8.
[218] US 5,854,056 (D2) at column 7.
[219] US 5,854,056 (D2) at column 8.
[220] Olson at [84].
202. The applicant submitted:
“D2 appears to mention a mat at column 3, line 5, in Figure 4 and a ‘dense mat’ at various locations (column 8, lines 37 and 59, column 9, line 5 and column 10 line 3), but does not include any actual description of the mat.”

and
“D2 also does not disclose a biomat having ‘a cell density of at least 30 g dry weight /L media’”[221]
[221] The applicant’s submissions filed 8 February 2023 at [95]-[96].

and
“D2 also does not disclose the integer of a biomat having ‘sufficient tensile strength and structural integrity to be handled without tearing’. As noted by Mr Olson ‘it is only when the dense mat product in D2 is dried into a “parchment” that it is described as ‘fairly rigid but strong enough not to break (see col. 11, lines 7-9)’ and that ‘there would be many substances that are rigid when dry but do not have sufficient strength to be handled when wet’.”[222]

and
“D2 also does not disclose the integer ‘a carbon source supporting aerial hyphae formation and a carbon to nitrogen ratio (C:N) of 7.5:1 or less supporting production of protein in the biomat’.”[223]
[222] The applicant’s submissions filed 8 February 2023 at [100], citing Olson at [83].
[223] The applicant’s submissions filed 8 February 2023 at [102].

203. The applicant also summarised a list of features recited in the claims which are not disclosed by D2.[224]
[224] The applicant’s submissions filed 8 February 2023 at [103].
204. I agree with the applicant that D2 does not provide a clear and unmistakable disclosure of all the features as defined in claims 1 and 23. I conclude that the opponent has not established that claim 1, claim 23 or any other claims of the opposed application lacks novelty in view of D2.
D3: Weber et al., Mycologist 20(2), pp 57-61, May 2006

205. D3 discloses the growth of a microbial mat on freshly cut birch stumps. The Birch stumps are described as prolific producers of “slime-flux”, an exudate, and the exudate supports growth of a thick (2-10 mm) slimy or rubbery microbial mat of yellow, orange and while colours.[225] The microbial consortia comprise nine different fungi, Xanthophyllomyces dendrorhous being the dominant yeast.[226]
[225] Weber et al., Mycologist 20(2), pp 57-61, May 2006 (D3) at page 57, section 1; page 58, Figures 1-4.
[226] Weber et al., Mycologist 20(2), pp 57-61, May 2006 (D3) at page 57, abstract.
206. Mr Olson stated that “D3 describes what is basically a solid substrate fermentation” which is “quite different from a tray fermentation (ie a surface fermentation method comprising growth on the surface of an aqueous media comprising nutrients in dissolved or submerged form).”[227]
[227] Olson at [131].

207. I agree with the applicant that D3 discloses a fermentation method which is quite different to the method described in the opposed application. Additionally, D3 does not provide a clear and unmistakable disclosure of all the features as defined in claims 1 and 23. I conclude that the opponent has not established that claim 1, claim 23 or any other claims of the opposed application lacks novelty in view of D3.
D4: WO 2016/004380, published 7 January 2016
208. D4 is related to work done on behalf of Montana State University which was subsequently assigned to the applicant of the opposed application (previously known as Sustainable Bioproducts).[228] D4 discloses the use of Fusarium oxysporum MK7 (ACTT Deposit No. PTA-10698) or its progeny for converting ligno-cellulosic feedstocks, algal biomass, and glycerol into energy-rich metabolites for bioenergy, for producing enzymes, antibiotics, fatty acids and lipids for commercial applications, and other useful processes and products.[229] Example 2 discloses lipid production by a Fusarium oxysporum MK7. Fusarium oxysporum MK7 inoculum and liquid media is disclosed as mixed with ligno-cellosic feedstocks, ligno-cellulosic feedstocks, carbon containing waste products or sugar monomers in an aerobic system. Figure 2 shows a fungal biomass of Fusarium oxysporum MK 7 after 7 days of growth on wheat straw at pH 2.5 under aerobic conditions. The fungal mat is disclosed as ready for lipid extraction.[230]
[228] The applicant’s submissions filed 8 February 2023 at [106].
[229] WO 2016/004380 (D4) at pages 1-2.
[230] WO 2016/004380 (D4) at pages 74-74; Figure 2.
209. Dr Kozubal, a co-inventor of D4, stated that Example 2 relates to a wet solid state fermentation process and explained that fungal inoculum was mixed with the feedstock so that mycelium grows throughout the feedstock and was totally integrated with the wheat straw.[231] I did not find any explicit disclosure in D4 of the type of fermentation that was used for Example 2. I am satisfied D4 does not provide a clear and unmistakable disclosure of a surface fermentation method to produce the claimed fungal biomat.
[231] Kozubal at [23].

210. The applicant summarised a list of features recited in the claims which are not disclosed by D4.[232] The list includes a carbon to nitrogen ratio (C:N) of 7.5:1 or less supporting production of protein in the biomat.
[232] The applicant’s submissions filed 8 February 2023 at [109].

211. I agree with the applicant that D4 does not provide a clear and unmistakable disclosure of all the features as defined in claims 1 and 23. I conclude that the opponent has not established that claim 1, claim 23 or any other claims of the opposed application lacks novelty in view of D4.
D5: Darouneh et al., African Journal of Microbiology Res. 3(9), pp 541-545, September 2009.
212. D5 discloses surface and submerged fermentation methods to produce citric acid by Aspergillus niger using chemically defined media or cane molasses. In the surface fermentation method, A. niger is disclosed to be cultivated on the liquid surface of media contained in trays. D5 discloses quantification of citric acid production but not quantification of fungal biomass.[233]
[233] Darouneh et al., African Journal of Microbiology Res. 3(9), pp 541-545, September 2009 (D5) at Figure 1, Table 1.
213. Regarding the “biomat” integer of claim 1, the opponent alleged that, although D5 does not use the term “biomat”, surface fermentation is undertaken in stainless steel trays.[234] The applicant submitted that it is far from inevitable that surface fermentation will result in a biomat as defined and claimed in the opposed application.[235] I tend to agree with the applicant.
[234] Ibid.
[235] The applicant’s submissions filed 8 February 2023 at [112].

214. Mr Olson noted that as D5 is directed to the production of citric acid, the conditions of fermentation would favour the production of citric acid (a metabolite) and would not favour the production of mycelium.[236] As discussed previously, I am of the view that the conditions that favour production of metabolite are not expected to produce thick and cohesive mats.
[236] Olson at [102].

215. Regarding the feature of “cell density of at least 30 g dry weight/L media”, Professor Kell estimated that the cell density in D5 as “around 50g/L”[237] However, the applicant submitted that:
“… D5 does not disclose the amount of citric acid produced per gram of fungal cell. It is therefore not possible to estimate the number of grams of the surface culture per litre of media. …Accordingly, the density integer is not inherently disclosed in D5.”[238]
[237] Kell at [92]-[93].
[238] The applicant’s submissions filed 8 February 2023 at [116].

I agree with the applicant.
216. The applicant submitted that D5 does not disclose “harvesting the filamentous fungal biomat by a process comprising inactivation of viability, deactivation of enzymes or a combination thereof”.[239] I agree.
[239] The applicant’s submissions filed 8 February 2023 at [114].
217. The applicant also summarised a list of other features recited in the claims which are not disclosed by D5.[240] I am satisfied that D5 does not provide a clear and unmistakable disclosure of all the features as defined in claims 1 and 23. I conclude that the opponent has not established that claim 1, claim 23 or any other claims of the opposed application lacks novelty in view of D5.
Conclusion on novelty
[240] The applicant’s submissions filed 8 February 2023 at [117].
218. I conclude that the opponent has not established that any of the claims of the opposed application lacks novelty in view of the cited prior art documents.
Inventive step
219. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, involves an inventive step. Subsection 7(2) states:
For the purposes of this Act, an invention is to be taken to involve an inventive step when compared with the prior art base unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed (whether in or out of the patent area) before the priority date of the relevant claim, whether that knowledge is considered separately or together with the information mentioned in subsection (3).

220. Subsection 7(3) prescribes the information that may be considered as:
The information for the purposes of subsection (2) is:
(a) any single piece of prior art information; or
(b) a combination of any 2 or more pieces of prior art information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have combined.

221. The prior art base for the purposes of inventive step is made up of (1) information in a document that is publicly available anywhere, and (2) information that is made publicly available through doing an act anywhere.[241]
[241] The Act, Schedule 1, definition of prior art base.
222. Once the CGK and relevant information have been identified, 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 Aickin J stated:
“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 be the steps of the inventor or not.”[242]
[242] [1981] HCA 12 at [45]; 148 CLR 262 at 286.

223. An expectation of success is not an additional requirement over and above matters of routine:
“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.”[243]
[243] Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] FCAFC 73 (Generic Health); 314 ALR 91 at [71].

Obviousness in light of CGK alone
224. The opponent alleged that any of unamended claims 1-34 lacks an inventive step in light of CGK. In particular, the opponent alleged “the combination of known features identified in the claims and in the manner described by the opposed application is obvious to the person skilled in the art.”[244] Additionally, the opponent alleged that:
“[t]he common general knowledge of a person skilled in the art at the relevant priority date may comprise:
i.various fermentation methods are routinely used to produce filamentous fungal materials such as mycelial mats;
ii.various media including aqueous media are routinely used and adjusted to develop and produce filamentous fungal materials including mats;
iii.filamentous fungus materials are routinely used in a range of applications including food products.” [245]
[244] The SGP dated 15 November 2021 at section 7.2.
[245] Ibid.

225. The applicant submitted:
“Professor Kell (and the Opponent) does not explain why it would have been obvious to combine all of the integers of each the various independent claims.

Even if the Opponent’s assertions as to CGK were accepted, this generalised characterisation of the common general knowledge is manifestly insufficient to render the particular combination of integers of the amended claims obvious.”[246]
[246] The applicant’s submissions filed 8 February 2023 at [144]-[145].

226. As discussed previously, Professor Kell’s declaration stated what he believed to be the CGK as at 1 March 2016, and Mr Olson disagreed with some matters considered CGK by Professor Kell. Both Professor Kell’s evidence and the opponent’s allegations do not explain why it would have been obvious to combine all the integers of each of the claims as amended (independent and appended claims). Even if I accept Professor Kell’s characterisation of the CGK at the priority date, it is apparent that the knowledge is insufficient to render the combination of integers defined in any one of the claims (as amended) obvious.[247]
[247] Kell at [71].
227. The applicant particularly noted Professor Kell’s characterisation of what he believed formed the CGK regarding the degree of aeration during surface liquid fermentation, and Mr Olson’s responses:
“… Professor Kell, in describing the factors necessary to achieve maximum mat thickness including aeration, states ‘the degree or [sic] aeration of the mat is important. If the mat cannot obtain sufficient air, then growth will stop or be curtailed. Aeration may be improved by agitation of the mat or nutrient medium.’ At [67], Professor Kell explained that maximum mycelia concentration will be dependent on a number of factors, including the degree of any agitation to facilitate aeration of the fermentation media and/or biomass.
As noted by Mr Olson these statements of Professor Kell ‘are at odds with what the Applicant seems to have identified as important for the production of the relatively thick and cohesive biomats described in the [opposed application]’, specifically, as discussed above at, particularly, paragraph 28(i) and (v), the Applicant found that the surface fermentation should be conducted in a manner wherein the surface of the aqueous media is undisturbed.’ (Emphasis added). Amended claim 1 includes this feature.”[248]
[248] The applicant’s submissions filed 8 February 2023 at [146]-[147].

228. Considering the statements of the experts on the issue of aeration and the insufficient knowledge in the CGK to render the combination of integers defined in the any one of the claims obvious, I am satisfied that, in light of the CGK alone, before the priority date, the PSA would not have taken routine steps leading to the combination claimed in any one of the claims (as amended) of the opposed application.

229. Consequently, I conclude that the opponent has not established that any of the claims of the opposed application lacks an inventive step in light of CGK before the priority date of the claims.
Obviousness in light of citations considered together with CGK
230. The opponent relies on the following 7 citations to allege lack of inventive step of unamended claims 1-34:
·Shahid et al., Pak. J. Pharm. Sci. 29(2), pp 407-414, published March 2016 (D1)
·US 5,854,056, published 29 December 1998 (D2)
·Weber et al., Mycologist 20(2), pp 57-61, published May 2006 (D3)
·WO 2016/004380, published 7 January 2016 (D4)
·Darouneh et al., African Journal of Microbiology Res. 3(9), pp 541-545, published September 2009 (D5)
·WO 2004/052103, published 24 June 2004 (herein referred to as D6); and
·Speelman, Fungal mats in solid state fermentation, Wageningen University, published 2005 (herein referred to as D7)[249]
[249] These documents are referred to as D1-D7 in the SGP. A copy of each document was provided with filing of the SGP, and are also provided in evidence as Exhibits DBK13- DBK19 of the declaration of Douglas B Kell dated 10 February 2022.

D1-D5
231. I have previously discussed the disclosures of D1-D5. None of D1-D5 discloses the claimed biomat which is uniquely thick, cohesive and has sufficient strength to enable it to be readily handled without tearing. D1-D5 also do not indicate how fermentation processes could be modified to obtain such a biomat. Furthermore, the documents do not provide a motivation for modifying the disclosure to obtain such a mat. The applicant submitted that the opponent’s evidence and assertions which are to the contrary are “plainly infected by hindsight”.[250] I would agree.
[250] The applicant’s submissions filed 8 February 2023 at [151], [153].
232. The applicant also submitted that D1 and D5 are directed to “surface fermentation processes with a goal to produce a metabolite (e.g., penicillin or citric acid), with the consequences that the fermentation conditions will be less favourable for biomass production.”[251] I agree with the applicant that this is quite different to the goal to produce fungal biomass. Additionally, the applicant noted that, since the prior art processes of D1 and D5 directed to the production of metabolites, they do not teach or suggest the inactivation step required by the claims.[252]
[251] The applicant’s submissions filed 8 February 2023 at [152].
[252] Ibid.

233. I conclude that the opponent has not established that any of the claims of the opposed application lacks an inventive step in light of any one of D1, D2, D3, D4 or D5 considered together with the CGK before the priority date of the claims.
D6: WO 2004/052103, published 24 June 2004
234. D6 discloses a process of preparing a biopesticide formulation for use against coffee berry borer (CBB). The process comprises the steps of isolating the fungus Beauveria bassiana from CBB cadavers, culturing the isolated fungus in a liquid medium to form a mycelial mat, inoculating mycelial agar plugs cut from the mycelial mat into a broth, incubating the broth and harvesting the conidiated mycelial by decantation.[253] The mycelial mat may be lyophilised.[254]
[253] WO 2004/052103 (D6), abstract.
[254] WO 2004/052103 (D6) at page 7.
235. D6 discloses that the use of B. bassiana as a pesticide relies on the asexual conidia of the fungus attaching to the host cuticle and degrading pectin, chitin, and lipids of the insect integument by various enzymatic activities. The fungus kills the host insects by depletion of their haemolymph nutrients and/or due to toxemia caused by fungal toxic metabolites.[255]
[255] WO 2004/052103 (D6) at page 4.

236. I note that D6 does not clearly disclose whether the mycelial mat is produced by surface fermentation or submerged fermentation. There is also no discussion of the tensile strength or structural integrity of the produced mycelial mats.

237. The applicant submitted that:
·Lyophilisation is not equivalent to inactivating the viability, or deactivating the enzymes, of fungal biomass of B. bassiana. Rather, lyophilisation results in different functionality and properties. Many filamentous fungi remain viable for many weeks or months after lyophilisation and are used as an inoculum in later fermentations as disclosed in D6.[256]
·The B. bassiana mats made according to D6 are functional as a biopesticide only if the fungus remains viable and enzymatically active, such that it can metabolise within the body of the pest insect host. This would not be possible if lyophilisation or any other process step taught by D6 resulted in inactivation of viability and/or deactivation of enzymes as the claims require.[257]
[256] The applicant’s submissions filed 8 February 2023 at [157].
[257] The applicant’s submissions filed 8 February 2023 at [158].

238. I agree with the applicant that D6 explicitly teaches away from inactivation of viability and or deactivation of enzymes of the B. bassiana mats.
239. I conclude that the opponent has not established that any of the claims of the opposed application lacks an inventive step in light of D6 considered together with the CGK before the priority date of the claims.

D7: Speelman, Fungal mats in solid state fermentation, Wageningen University, D7 is a PhD thesis regarding solid state fermentation using fungi. D7 describes the relevance and importance of interactions between fungal mycelia and the underlying solid substrate.[258]
[258] Speelman, Fungal mats in solid state fermentation, Wageningen University, (D7) at page 11, first paragraph; page 13, second paragraph; page 18, first paragraph; page 107, second paragraph; page 147, second paragraph page 148, second paragraph.
241. Since solid state fermentation is different from liquid surface fermentation, I cannot see the relevance of D7. I find there is no motivation for a PSA to modify the teachings of D7 to arrive at the invention claimed in the opposed application.

242. I conclude that the opponent has not established that any of the claims of the opposed application lacks an inventive step in light of D7 considered together with the CGK before the priority date of the claims.
Conclusion on inventive step
243. I conclude that the opponent has not established that any of the claims of the opposed application lacks an inventive step in light of CGK before the priority date of the claims, whether that knowledge is considered separately or together with the information in the cited documents.
Manner of manufacture
244. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies. It is well established that this involves asking whether the necessary quality of inventiveness is apparent on the face of the specification (“the threshold requirement”). In NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd the High Court said:
“if it is apparent upon the face of the specification, when properly construed, that the quality of inventiveness necessary for there to be a proper subject of letters patent under the Statute of Monopolies is absent, one need go no further”.[259]

and in Bristol-Myers Squibb Co v FH Faulding & Co Ltd the Federal Court said:
“if, on the basis of what was known, as revealed on the face of the specification, the invention was obvious or did not involve an inventive step – that is, would be obvious to the hypothetical non-inventive and unimaginative skilled worker in the field – then the threshold requirement of inventiveness is not met.”[260]
[259] [1995] HCA 15; 183 CLR 655 at [9].
[260] [2000] FCA 316; 46 IPR 553 at [30].

245. Another formulation of the requirement is found in Commissioner of Patents v Microcell Ltd:
“We have in truth nothing but a claim for the use of a known material in the manufacture of known articles for the purpose of which its known properties make that material suitable. A claim for nothing more than that cannot be subject matter of a patent, …”[261]
[261] [1959] HCA 71; (1959) 102 CLR 232 at 251.

246. The opponent alleged that the invention claimed in the unamended claims 1-34 of the opposed application are not for a manner of manufacture. The core of the opponent’s allegation generally relates to the so-called “threshold requirement” of inventiveness in the face of the specification.[262]
[262] The SGP dated 15 November 2021 at section 4.
247. The applicant submitted:
“Here, the specification positively asserts that the method and the resulting biomat are new and inventive. The specification does not anywhere admit that the claimed matter is not new and inventive over the prior art. Thus, there is no evidence that the specification ‘on its face’ shows the claimed invention is not a manner of new manufacture.”
The various integers of the claims are clearly defined to be in an arrangement that would be readily understood by the skilled reader to be in a working interrelationship. This is apparent from the claim language itself.
The specification (including the claims) clearly explains the advantages of the claimed biomat over the prior art, and nowhere suggests that the claimed invention is a mere working direction or mere collocation of known components.
This ground must fail.”

I agree.
248. The opponent has not established that the invention in any of the claims of the opposed application is not a manner of manufacture.
Conclusions
249. The opponent has not established that claims 1-39 of the opposed application fail to comply with the grounds of manner of manufacture, novelty, inventive step, utility, sufficiency, disclosure of best method, support, and clarity. Therefore, the opposition is unsuccessful.

250. Subject to appeal, I direct the application proceed to grant.
Costs
251. Both the applicant and the opponent seek the cost of the opposition proceedings.[263] During the oral hearing, the applicant noted that the opponent had not withdrawn the opposition despite not filing any evidence directed to the amended claims, not filing any written submissions, and not attending the oral hearing. I agree that the opponent’s lack of action appears to indicate that the opponent lost interest in prosecuting the opposition. I note that when an opponent has lost interest, the usual and appropriate course of action is for the opponent to withdraw their opposition. In that circumstance the Commissioner’s usual practice is to consider whether the application should be re-examined based on the material filed in the opposition prior to grant.
[263] The applicant’s submissions filed 8 February 2023 at [246]; the SGP dated 15 November 2021, last page.
252. Costs normally follow the event. However, in the present case the applicant filed amendments during the opposition that were ultimately allowed. As is clear from the reasons in my decision, the amendments introduced one or more features that:
a.correspond to the technical contribution to the art;
b.was not clearly and unmistakably disclosed in any one of D1-D7; and
c.was not part of the CGK.

253. Since the amendments introduced features that contributed to at least overcoming the ground regarding lack of support, the opponent had a degree of success in the opposition despite the opposition being ultimately unsuccessful.
254. As discussed previously, the applicant was notified of allowance of the amendments on 7 September 2022, but the allowance was ultra vires because an excess claim fee had not been paid by the due date. While the amendments were properly allowed on 3 February 2023, the notification of allowance on 7 September 2022 clearly informed the parties of the basis upon which the opposition would subsequently proceed. In view of the facts of this case, I consider it is reasonable to consider the award of costs based on the parties’ actions before and after 7 September 2022.
255. In the present circumstances, the amendments filed during the opposition clearly influenced the overall result of the opposition. Consequently, I award costs according to schedule 8 of the Patents Regulations 1991 incurred before 7 September 2022 against the applicant, The Fynder Group, Inc. I award costs according to schedule 8 incurred after 7 September 2022 against the opponent, Marlow Foods Limited.
Dr A. Lim
Delegate of the Commissioner of Patents
Annex A: The claims of the opposed specification
1. A filamentous fungal biomat comprising a filamentous fungi, wherein the biomat: is of a thickness of 1 mm to 30 mm and comprises at least two structurally different cell layers in contact with each other, comprising an aerial hyphae layer and a bottom mycelium layer, wherein the aerial hyphae layer is less dense than the bottom mycelium layer; has a cell density of at least 30 g dry weight /L media; has sufficient tensile strength and structural integrity to be handled without tearing; and is produced by a surface fermentation method, said method comprising:
(i) growing the filamentous fungi on the surface of an aqueous media in an undisturbed state to a cell density of at least 30 g dry weight /L media, wherein the aqueous media comprises nutrients in dissolved or submerged form comprising a carbon source supporting aerial hyphae formation and a carbon to nitrogen ratio (C:N) of 7.5:1 or less supporting production of protein in the biomat; and
(ii) harvesting the filamentous fungal biomat by a process comprising inactivation of viability, deactivation of enzymes or a combination thereof.
2. The biomat according to claim 1, wherein the cell density is at least 50 g dry weight/L media or at least 75 g dry weight /L media.
3. The biomat according to claim 1 or 2, wherein the ratio of thickness of the bottom layer to the thickness of the upper aerial hyphae layer is at least 0.41.
4. The biomat according to any one of the preceding claims, wherein the biomat has a protein content of at least 40%.
5. The biomat according to any one of the preceding claims, wherein the filamentous fungi is selected from the group consisting of Fusarium, Fusisporium, Pseudofusarium, Gibberella, Sporotrichella, Aspergillus, Penicillium, Trichoderma, a species within the order Mucorales, the filamentous fungal strain designated as MK7, yeasts capable of producing filaments, and combinations thereof.
6. The biomat according to any one of the preceding claims, wherein the filamentous fungi are selected from the group consisting of a Fusarium species and a Rhizopus species.
7. The biomat according to any one of the preceding claims, wherein the filamentous fungi is selected from the group consisting of the strain designated as MK7 (ATCC Accession Deposit No. PTA-10698), Fusarium venenatum and Rhizopus oligosporus.
8. The biomat according to any one of the preceding claims, wherein the filamentous fungi is the strain designated as MK7 (ATCC Accession Deposit No. PTA-10698).
9. The biomat according to any one of the preceding claims, wherein the biomat comprises between 5% and 20% solids.
10. The biomat according to any one of the preceding claims, wherein the tensile strength of the biomat is at least 0.2 kg/cm of mat width.
11. The biomat according to any one of the preceding claims, wherein the biomat has an average filament length of between 0.05 cm and 2 cm.
12. The biomat according to any one of the preceding claims, wherein the biomat comprises amino acids selected from tryptophan, cysteine, methionine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, isoleucine, leucine, phenylalanine, proline, serine, threonine, lysine, tyrosine and valine produced by the filamentous fungi.
13. The biomat according to any one of the preceding claims, wherein the biomat comprises all essential amino acids.
14. The biomat according to any one of the preceding claims, wherein the biomat comprises protein comprising about 20% branched chain amino acids.
15. The biomat according to any one of the preceding claims, wherein the pH of the aqueous media is at least 2.7.
16. The biomat according to any one of the preceding claims, wherein the pH of the aqueous media is less than 7.0.
17. The biomat according to any one of the preceding claims, wherein the pH of the aqueous media is between 4.5 and 5.5.
18. The biomat according to any one of the preceding claims, wherein the harvesting process comprises drying the biomat in a temperature controlled oven.
19. The biomat according to any one of the preceding claims, wherein the harvesting process comprises drying the biomat in a temperature controlled oven at 60° ± 1°C for 45 minutes.
20. The biomat according to any one of the preceding claims, wherein the aqueous media comprises a carbon source selected from the group consisting of sugars, starch, carbohydrates, glycerol, whey, lignocellulosic feedstock, acid whey and combinations thereof.
21. A food product, comprising the biomat defined in any one of the preceding claims.
22. The food product according to claim 21, wherein the food product is selected from the group consisting of a human food, fish feed and animal feed.
23. A method of producing a filamentous fungal biomat by a surface fermentation method suitable for use in a food product comprising:
(a) inoculating an effective amount of at least one filamentous fungus into an aqueous artificial growth media; wherein the growth media comprises nutrients in dissolved or submerged form comprising a carbon source supporting aerial hyphae formation and a carbon to nitrogen ratio (C:N) of about 7.5:1 or less supporting production of protein content;
(b) incubating the inoculated growth media in an undisturbed state by surface fermentation to produce a filamentous fungal biomat of a cell density of at least 30 g dry weight /L media; and
(c) harvesting the filamentous fungal biomat by a process comprising inactivation of viability, deactivation of enzymes or a combination thereof,

wherein the biomat: is of a thickness of 1 mm to 30 mm and comprises at least two structurally different cell layers in contact with each other, comprising an aerial hyphae layer and a bottom mycelium layer, wherein the aerial hyphae layer is less dense than the bottom mycelium layer; has a cell density of at least 30 g dry weight/L media; and has sufficient tensile strength and structural integrity to be handled without tearing.
24. The method according to claim 23, wherein the artificial growth media comprises a carbon source selected from the group consisting of sugars, starch, carbohydrates, glycerol, whey, lignocellulosic feedstock, acid whey and combinations thereof.
25. The method of claim 24, wherein the sugar is selected from glucose, galactose, mannose, trehalose, sucrose, arabinose, maltose, xylose and/or fructose.
26. The method of claim 24, wherein the lignocellulosic feedstock is selected from the group consisting of wheat straw, barley straw, rice straw, small grain straw, corn stover, corn fibers, corn steep liquor, beet pulp and a combination thereof.
27. The method of claim 24, wherein the carbohydrate is selected from the group consisting of monosaccharides, disaccharides, oligosaccharides, polysaccharides and a combination thereof.
28. The method according to claim 23, wherein the artificial growth media comprises a carbon source comprising a waste selected from the group consisting of an agricultural waste, a clinical organic waste, a municipal organic waste, a food processing waste, a biofuel production waste, an industrial waste, a lignocellulosic containing waste, dairy waste, slaughterhouse waste and a combination thereof.
29. The method according to any one of claims 23 to 28, wherein the artificial growth media has an osmotic pressure of about 18.6 atm.
30. The method according to any one of claims 23 to 29, wherein the artificial growth media has an ionic strength of about 0.368 molar.
31. The method according to any one of claims 23 to 30, wherein the artificial growth media comprises ammonium nitrate, urea, potassium dihydrogen phosphate, calcium chloride, magnesium sulfate, and yeast extract.
32. The method according to claim 31, wherein the artificial growth media further comprises iron sulfate, zinc sulfate, manganese chloride, cobalt chloride, copper sulfate, and boric acid.
33. The method according to any one of claims 23 to 32, wherein the artificial growth media comprises a nitrogen source.
34. The method according to claim 33, wherein the nitrogen source is selected from the group consisting of nitrate salts, ammonium salts, proteins, peptides, urea, waste streams
comprising nitrogen, and combinations thereof.
35. The method according to any one of claims 23 to 34, wherein the pH of the artificial growth media is at least 2.7.
36. The method according to any one of claims 23 to 34, wherein the pH of the artificial growth media is between 4.5 and 5.5.
37. The method according to any one of claims 23 to 36, wherein the harvesting process comprises drying the biomat in a temperature controlled oven.
38. The method according to any one of claims 23 to 37, wherein the harvesting process comprises drying the biomat in a temperature controlled oven at 60° ± 1°C for 45 minutes.
39. A method of removing carbon and nitrogen from a feedlot lagoon water comprising:
(a) adjusting the lagoon water to a pH 2.6;
(b) inoculating the adjusted lagoon water with strain MK7 (ATCC Accession Deposit No. PTA-10698); and
(c) producing a filamentous fungi biomat on the surface of the lagoon;

wherein the biomat contains the carbon and nitrogen removed from the lagoon water.

Evidence	Declarant	Exhibits	Date	Reference
In Support	Douglas Bruce Kell	DBK-1 to DBK-20	10 February 2022	Kell
In Answer	Phillip T Olson	PO-1 to PO-9	16 May 2022	Olson
Mark A Kozubal	MAK-1	12 May 2022	Kozubal

SSF	SSSF
Density (g dry weight strain MK7 biomass/kg of medium: substrate mixture)	<5	120-180
Tensile Strength	Not measurable	Wet biomass: 0.05-0.24 kg/com width, average ~0.009 kg/com width. Dry biomass (no subsequent processing): 2-6 kg/com width, average -3 kg/com width
Osmotic pressure of medium (atm)	3.4	18.6
Ionic strength of medium (molar)	0.077	0.368
Cell type used for inoculum	Stationary phase filamentous cells (i.e. cells> 100 μm in length)	Late exponential phase planktonic cells (i.e. cells <20 μm in length)
Lignocellulose in medium (%)	>25	2.5-25
Average filament length	0.001-0.02 cm	0.05-2 cm
Filament orientation	Random	Parallel
Final composition (%)	Less than 5% fungi	Grater than 95% fungi
Final biomat consistency	Fragile, not cohesive, heterogeneous	Robust, cohesive, Homogenous