DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Applicant claims domestic benefit under 35 U.S.C. 199(e) to U.S. Provisional Patent Application Nos 63/189,314, filed May 17, 2021; 63/244,821, filed September 16, 2021; and 63/267,191, filed January 26, 2022. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6/1/2023; 6/16/2023; 7/24/2023; 1/30/2024; 7/31/2024; 10/23/2024; 10/23/2024; and 5/5/2025 is acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 99-119 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “whole-protein” in claim 99 is a relative special term which renders the claim indefinite. The term “whole-protein” is not clearly and specifically defined in the specification. Further, the term is not defined by the claim, the specification does not provide a clear standard for ascertaining the meaning of the term, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In other words, there is no indication as to what amounts to a whole-protein, when compared to any other possible protein. Is the “whole-protein” a separate isolated protein that is added to composition? Or is the “whole-protein” protein that is produced by the fungi and/or bacteria otherwise present in the composition. Further, another possible meaning of “whole-protein” is that a protein is fully intact, i.e. has not undergone any steps of degradation, hydrolysis, or cleavage. Due to these issues with multiple interpretations of the term, one would not be able to determine the metes and bounds of the claim protection which is sought and the claim is indefinite.
The dependent claims 102-106 further limit the claimed whole protein to whole-protein having a certain threshold of a digestibility amino acid score. The specification states, at [0073], that “The protein can be a whole-protein, meaning that it has a protein digestibility amino acid score (PDCAAS) equal to at least any of 0.8, 0.85, 0.9, 0.95 or 1.0 e.g., equal to at least 0.9, e.g., 1.0.”. See also the provided NPL document Schaafsma G. “The protein digestibility-corrected amino acid score (PDCAAS)—a concept for describing protein quality in foods and food ingredients: a critical review”. Journal of AOAC International. 2005 May 1;88(3):988-94.
Therefore, these limitations have been interpreted, under the B.R.I. of the terms in view of the specification and of the level of knowledge of the art, to refer to the PDCAAS score, which is known to the art. However, such limitations do not render the claim definite, because it remains unclear if the whole-protein is derived from and the claimed fungal and bacterial composition, or whether the whole-protein is a separate entity added to the composition. Further, there is a new issue because one cannot determine if the whole-protein that has the requisite PDCAAS score is separate and distinct from all of the protein that might exist in the culture of the fungi and bacteria, or if the claim is only referring to a portion of the protein, i.e. the edible proteins which meet the claimed criteria regarding digestibility.
Clarification and/or amendments are requested.
Claims 101-119 each recite “the composition of claim 1”, referencing the presently cancelled claim 1. This is indefinite as no claim 1 exists in the pending claims. However, it can be inferred that the claims should instead say “the composition of claim 99” and have been afforded this interpretation to undergo examination on the merits. Correction is requested.
Claim Interpretation
In light of the 112(b) rejections and issues of indefiniteness discussed above, for the purposes of evaluating the prior art for compact prosecution, the claims have been interpreted under the Broadest Reasonable Interpretation (B.R.I.), in light of the specification and general knowledge in the art, as referencing any intact protein (i.e. whole protein) that may be found in a composition or culture of bacteria and fungi.
The limitations reciting a “digestibility amino acid score” have been interpreted, as discussed above, as requiring that the protein has a protein digestibility amino acid score (PDCAAS) equal to or greater than the recited value (for claims 102-106).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 99-110 and 113-119 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
For determining subject matter eligibility, the following analysis was considered, per MPEP § 2106.
Patent Eligibility Analysis Step 1: Step 1 of the eligibility analysis asks: is the claim to a process, machine, manufacture or composition of matter? Yes, the claims are directed to a composition. (Claims 99-119, STEP 1: YES).
Patent Eligibility Analysis Step 2A Prong 1: Step 2A, prong 1 asks: does the claim recite an abstract idea, law of nature, or a natural phenomenon (product of nature)?
Claims 99-119 all recite a composition comprising a cellulose scaffold and a whole-protein, wherein the cellulose scaffold is produced by a microbial consortium comprising:(i) one or more filamentous fungi; and(ii) one or more cellulose-producing bacteria. The one or more cellulose-producing bacteria comprise one or more of Komagataeibacter, Acetobacter, and Gluconacetobacter, the one or more filamentous fungi comprise one or more of Aspergillus, Neurospora, and Fusarium, and/or the microbial consortium may include a species of Saccharomyces, according to dependent claims 107-110. These are all naturally occurring organisms. No manipulation to the microorganisms is described. Thus, the B.R.I. of claims 99-119 include limitations encompassing natural products.
When a claim recites a nature-based product limitation, the markedly different characteristics (MDC) analysis is used to determine whether the natural product has markedly different characteristics from its natural counterpart (see MPEP 2106.04(c)). MPEP § 2106.04(c) explains “Where the claim is to a nature-based product produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts.”
In this case, the appropriate natural counterpart for the microbial consortium of claims 99-119 would be a combination of at least one of the natural occurring filamentous fungi and at least one cellulose-producing bacteria. Fungi and Bacteria are living organisms and thus clearly produce protein. The interpretation of “whole-protein” as described above indicates that proteins are wholly digestible.
The second step in the MDC analysis is to identify appropriate characteristics to compare. Appropriate characteristics can be expressed as the nature-based product’s structure, function, and/or other properties, and are evaluated on a case-by-case basis. In this case, the appropriate characteristics include: biological functions or activities including the production of cellulose by the bacteria and the presence of any useful digestible proteins; phenotypic characteristics which include functional and structural characteristics such as the shape, size, color, and behavior of an organism; and structure and form (chemical, genetic or physical) of the natural components. The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally-occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally-occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, the inventor must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart (MPEP § 2016.04(c).II.C.). If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception.
No characteristics of the individual naturally-derived microbial consortium are markedly changed in the claimed composition. The bacteria and fungi that comprise the consortium are all naturally occurring. Further, bacteria, including cellulose-producing bacteria Komagataeibacter, Acetobacter, and/or Gluconacetobacter, can be found together in natural or fermenting samples with filamentous fungi. See, for example the evidence and data presented in Figures 1 and 5 of Nie et al. (“Unraveling the correlation between microbiota succession and metabolite changes in traditional Shanxi aged vinegar.” Sci Rep. 2017 Aug 23;7(1):9240); Figure 6 of Jiang et al. (“Microbial dynamics and flavor formation during the traditional brewing of Monascus vinegar.” Food Research International. 2019 Nov 1;125:108531); and Figure 2 of Brischetto et al. (“The microbiome analysis of ripen grape berries supports the complex etiology of sour rot.” Frontiers in Microbiology. 2024 Nov 7;15:1450443). The art cited is evidence that microbe communities found in naturally rotting and/or fermenting biomaterial may comprise a combination of natural microorganisms including those as claimed herein. Further, the cited art provides examples wherein the fermentation mixture and or rotting plant product contains Saccharomyces.
When considered as a whole composition, there is no evidence or suggestion that the claimed product has any markedly different characteristic than a combination of the individual naturally occurring products.
Therefore, the claimed product lacks markedly different characteristics, and is a product of nature exception (Claims 99-110 and 113-119, Step 2A, Prong 1: YES).
However, claims 111 and 112 require that the composition is shaped into a food product, including various shapes. This would result in transformed structural characteristics such as changed shape, size, and behavior, and thus the composition of claims 111 and 112 is clearly not directed to a natural product (Claims 111 and 112, Step 2A, Prong 1: NO).
Patent Eligibility Analysis Step 2A Prong 2: Step 2A, prong 2 asks: does the claim recite additional elements that integrate the judicial exception into a practical application?
Claim 99 recites that there is a cellulose scaffold produced by the microbial consortium. This is considered a natural produce of the cellulose-producing bacteria, including the naturally occurring Komagataeibacter, Acetobacter, and/or Gluconacetobacter. Thus, the cellulose scaffold cannot integrate the natural product exception into a practical application because this element is a natural product itself.
Claims 107-110 merely limit the composition further by reciting specific genus of the microorganisms. These are all considered product-of-nature exceptions, and consortiums having one or more of these organisms are known in nature, as indicated by the cited art above.
Claim 100 recites that the cellulose scaffold comprises killed bacteria and/or fungi. Claim 101 recites that the cellulose scaffold is not dehydrated. The limitations of claim 100 and 101 are directed to natural states of the bacteria and fungi consortium. Microorganisms are found in either living or dead states in nature. Further, the state of being not dehydrated is the common growing conditions for such bacteria and fungus (i.e. in liquid or moist environments).
Claims 102-106 recites functional limitations regarding the whole-protein. These have been found to be natural properties of the provided proteins, according to the specification. Such limitations amount to properties arising from the ineligible microorganisms. These do not integrate the judicial exception into a natural product.
Claim 113-119 recite additional properties of the compositions, by having a certain amount of fiber (presumably derived from the naturally-occurring cellulose) or protein which must be present, but these concentrations do not differentiate the claims from a natural product, nor does it recite a practical application thereof.
The additional elements recited in the claims do not integrate the judicial exception into a practical application as these functional limitations merely reflects innate capabilities of the natural product, and does not require a particular or directed application.
Therefore, the judicial exception is not integrated into a practical application because the claims do not recite any additional elements other than the naturally-occurring product(s) and innate functional characteristics thereof (Claims 99-110 and 113-119, Step 2A, Prong 2: NO).
Patent Eligibility Analysis Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Claim 99 recites that there is a cellulose scaffold produced by the microbial consortium. The cellulose scaffold is itself a natural product, and thus is not considered an additional element that amounts to significantly more than the ineligible natural product.
None of the additional elements recited in the dependent claims 100-110 and 113-119 amount to significantly more than the ineligible natural product.
Claims 107-110 do not include additional elements other than limiting the selection of the microorganisms. These are all considered product-of-nature exceptions, and consortiums having one or more of these organisms are known in nature, as indicated by the cited art above.
Claim 100 recites that the cellulose scaffold comprises killed bacteria and/or fungi. Claim 101 recites that the cellulose scaffold is not dehydrated. The limitations of claim 100 and 101 are directed to natural states of the bacteria and fungi consortium. When considered as a whole, this does not represent an inventive concept amounting to significantly more than the natural product in a natural environment.
Claims 102-106 recites functional limitations regarding the whole-protein. These have been found to be natural properties of the provided proteins, according to the specification. Such limitations amount to properties arising from the ineligible microorganisms. Claim 113-119 also recite additional properties of the compositions, by having a certain amount of fiber (presumably derived from the naturally-occurring cellulose) or protein which must be present.
These limitations do not practically limit the claims to anything other than the natural product(s), instead these merely recite specific elements or functional properties of the product. The recitation of an innate property or characteristic of a natural bacteria does not result in significantly more than the judicial exception.
Further, the providing in a groups or consortium, as well as adjustments or optimization of a concentration of a natural product, does not result in any particular transformation of the ineligible natural product, nor does an adjustment of concentration constitute an inventive concept. Adjustment of concentration to optimize a particular activity of a microorganisms (such as metabolism, fermentation, or compound degradation) does not result in significantly more than the ineligible natural product. The providing of the claimed composition does not result in significantly more than a mixture of ineligible natural products.
See for example, MPEP (2106.04(b).I, which describes that: “[t]he courts have identified the following concepts and products as examples of laws of nature or natural phenomena… ii. qualities of bacteria such as their ability to create a state of inhibition or non-inhibition in other bacteria, Funk Bros., 333 U.S. at 130, 76 USPQ at 281”. The instant claims are reciting similar naturally occurring properties of bacteria as explained therein. Production of cellulose is a naturally occurring activity of cellulose-producing bacteria, and any benefits conveyed by having the cellulose in the composition would also intrinsically be present in natural consortia.
When considered individual or in combination, the claims as a whole do not amount to more than the judicial exception.
Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception (Claims 99-110 and 113-119, Step 2B: NO).
As such, the claims do not qualify as eligible subject matter. For these reasons, claims 99-110 and 113-119 are rejected under section 101 as being directed to ineligible subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 99-101 and 107-119 are rejected under 35 U.S.C. 103 as being unpatentable over Macur et al. (US PGPub 20200270559 to Sustainable Bioproducts, Inc, cited on IDS filed 6/1/2023) in view of Lu et al. (WO2021035115, provided with IDS filed 1/30/2024).
Macur et al. (‘559) discloses edible filamentous fungal biomat formulations provided as standalone protein sources and/or protein ingredients in foodstuffs (Title, Abstract). Macur also teaches methods associated therewith, foodstuffs containing edible filamentous fungi, and methods and uses thereof ([0002]). Macur teaches that only certain protein food sources are “complete” proteins, meaning that they contain all of the essential amino acids (thus “whole-protein”, as best understood from the instant specification) ([0004]). Macur teaches that one source of complete protein can be obtained from edible filamentous fungi, such as Fusarium venenatum (formerly classified as Fusarium graminearum) ([0005]).
Macur teaches that the edible filamentous fungi is grown in the form of biomat comprising at least one membrane that may be comprised of polymers, including, inter alia, cellulose acetate, mixed cellulose esters, and other fabrics or molding materials ([0078]-[0084]). Macur also teaches that the method may further comprise providing cyanobacteria in the bioreactor, wherein the cyanobacteria provide at least one of oxygen gas and carbon to promote the growth of the biomat ([0078]). Macur teaches that the fungal biomats can be grown in trays (i.e. molds), under various culture conditions ([0309]-[0315]). Macur also teaches examples wherein the fungi biomats are grown in encapsulated bioreactors with membranes comprising polypropylene and polycarbonate ([0316]).
In regards to claim 100, Macur teaches that biomats comprising the fungi food product are steamed at least to the point where biomat viability is reduced such that further biomat growth and/or cellular reproduction within a biomat is negligible ([0222]), thus Macur teaches that the microorganisms are killed (i.e. subjected to high temperature steam), yielding inactivated edible filamentous fungal biomats that can be used directly as a protein source ([0223] and [0217]: “Elimination of cell viability and the potential of further biomat growth is desired in some instances”).
Regarding claim 101, Macur teaches that the food product may be dried, such as in Example 19 ([0356]), yet other examples teach non-dehydrated products, such as meat replacements (i.e. chicken nugget shapes of Example 13 and sausages of Example 14) which involved substantially no drying steps.
Regarding claims 108 and 109, Macur teaches that in some embodiments the filamentous fungi is selected from the genera Fusarium, Aspergillus, Trichoderma, and Rhizopus ([0177]). Macur also teaches that the protein product can include Aspergillus, such as Aspergillus oryzae or Aspergillus sojae, to make a soy sauce food product ([0248]).
Regarding claim 110, Macur teaches that Saccharomyces cerevisiae or other yeasts used in brewing or baking may be added with the fungal protein composition to make e.g. a baked good-analog food ([0248]).
Regarding claims 111 and 112, Macur teaches that the food product can be shaped into a food product, including shapes of a strip, a log, or a slab, among others (e.g. [0327]: “Portions of this biomat mixture (˜30 g) were formed into nugget shapes”; [0454]: “Strain MK7 biomat was cut into strips”; [0525]: “Each portion of dough was rolled into a shape similar to that of a hot dog”, a hot dog clearly being a shape of a log or cylinder).
Regarding claim 113, Macur teaches that a product including the filamentous fungi Fusarium strain MK7 has a total fiber content of 23.3% and one made from Fusarium venenatum has a total fiber content of 25.1% (see [0364]-[0366], Example 23).
Regarding claims 114-119, Macur teaches that filamentous fungi can comprise protein in “a range between 30 wt. % and 80 wt. or in any whole number percentage range between 30 wt. % and 80 wt. %. See Examples 21-23” ([0182]). In Example 23, Macur teaches that a product of the filamentous fungi Fusarium strain MK7 has a total protein content of 43-52% and one made of Fusarium venenatum has a total protein content of 42 (see [0364]-[0366]).
However, Macur does not teach in a single embodiment, a microbial consortium comprising:(i) one or more filamentous fungi; and (ii) one or more cellulose-producing bacteria, used to produce the cellulose scaffold.
Lu et al. (WO ‘115) teaches compositions and methods for bacterial cellulose materials with engineered microbial co-cultures (Title, [002]). Lu teaches that bacteria cellulose is beneficial for its use in engineered living materials (ELMs), which recreate desirable properties from natural biological materials ([003]). Lu teaches that certain gram-negative acetic acid bacteria - particularly members of the Komagataeibacter and Gluconacetobacter genera - are able to produce large quantities of extracellular cellulose, and when grown in static liquid culture, these BC-producing bacteria secrete cellulose, in the form of numerous individual glucan chains bundled into ribbon-like fibrils ([0062]). Lu states that “Over the course of several days, a thick floating mat forms - referred to as a pellicle - which is composed of a network BC fibrils, within which the BC-producing bacteria become embedded” (Fig 1A, [0062]).
Lu teaches that in addition to the cellulose-producing bacteria, the co-culture comprises a cell, which may be a fungal cell such as Saccharomyces spp., Schizosaccharomyces spp., Pichia spp., Paffia spp., Kluyveromyces spp., Candida spp., … and Aspergillus spp., Pennicilium spp., Fusarium spp., Rhizopus spp., Acremonium spp., Neurospora, among others. ([00117]).
Lu teaches, in embodiments, that the bacterial-produced cellulose is derived from, for example, a species of the genus Komagataeibacter and comprises a pellicle ([0030], Figure 1A). Lu teaches, in some aspects, isolated bacterial cellulose (BC)-based living compositions that comprise a stable co-culture of Komagataeibacter rhaeticus ( K . rhaeticus) and an engineered Saccharomyces cerevisiae ( S . cerevisiae ) strain ([0010]).
Lu et al. explains that benefits of the co-culture system are that the co-culture approach can be used to grow functional materials that provide higher yield BC production and result in stable, cultures, which survive over many cycles of passaging (see [00118]-[00119]).
Therefore, before the effective filing date of the claimed invention, to one of ordinary skill in the art, it would have been obvious to produce a composition comprising a bacterial-derived cellulose scaffold as claimed, wherein the product includes a filamentous fungi having a whole protein as taught in Macur et al, wherein the composition includes a co-culture (i.e. a consortium) of a cellulose-producing bacteria and a filamentous fungi in a cellulose pellicle, wherein the pellicle or scaffold is produced by the bacteria as taught in Lu et al. for the predictable benefits of improved cellulose yield and an improved food production process.
The production of useful edible fungi products such as Fusarium-derived whole protein is taught in the art, as evidenced in Macur. The inclusion of other filamentous fungi such as Fusarium, Aspergillus or Neurospora would have also been reasonable with the methods taught in Lu as these are all possible fungus/yeast alternatives described in the methods of Lu et al..
Therefore, one would have been adequately motivated to produce a filamentous fungi-derived protein including the protein food source taught in Macur, derived from Fusarium, with a bacterial cellulose scaffold because the art teaches that these are complete protein source containing all of the important dietary amino acids. The improvements of a co-culture of a cellulose-producing bacteria with fungi are taught in Lu et al., and include improved yield and long-term stable culture propagation.
Further, the use of bacteria-derived cellulose to produce the food product taught in Macur would predictably eliminate the use of plastic or artificial material such as the polypropylene discussed in embodiments therein. Indeed, Macur suggests that other cellulose-containing materials could be employed as the membrane for the biomat. The selection of a bacterial-produced cellulose yielding a pellicle as the culture scaffold as taught in Lu would have been readily known to one of ordinary skill in the art. It would thus logically follow from the combined teachings of Lu et al. and Macur et al. that a co-culture of a cellulose-producing bacteria and a filamentous fungi would yield a cellulose pellicle harboring the consortium of bacteria, including the whole protein derived from the fungi.
Regarding claims 100 and 101, Macur teaches that the microorganisms are killed (i.e. subjected to high temperature steam), yielding inactivated edible filamentous fungal biomats that can be used directly as a protein source and teaches the production of non-dehydrated products, such as meat replacements which involved substantially no drying steps. These would have been obvious implementations and variations of the composition having a co-culture described above.
Regarding claim 107, Lu et al. establishes that Komagataeibacter and Gluconacetobacter are known cellulose producing bacteria in the art, and thus the selection of either of these for making a pellicle-containing food product would have been obvious to one of ordinary skill.
Regarding claims 108 and 109, Macur teaches that the filamentous fungi for the protein source is selected from genera including Fusarium, Aspergillus, and Rhizopus.
Regarding claim 110, Macur teaches that Saccharomyces cerevisiae or other yeasts used in brewing or baking may be added with the fungal protein composition to make e.g. a baked good-analog food ([0248]). Additionally, Lu et al. teaches specific embodiments including Saccharomyces cerevisiae in a co-cultured cellulose pellicle from Komagataeibacter.
The selection and providing of these fungi and additional yeast would have been a matter of routine selection and optimization to one of ordinary skill in the art.
Regarding claims 111 and 112, Macur teaches that the food product can be shaped into a food product, including shapes of a strip, a log, or a slab, among others (e.g. [0327]: “Portions of this biomat mixture (˜30 g) were formed into nugget shapes”; [0454]: “Strain MK7 biomat was cut into strips”; [0525]: “Each portion of dough was rolled into a shape similar to that of a hot dog”, a hot dog clearly being a shape of a log or cylinder).
Regarding claim 113, Macur teaches that a product including the filamentous fungi Fusarium strain MK7 has a total fiber content of 23.3% and one made from Fusarium venenatum has a total fiber content of 25.1% (see [0364]-[0366], Example 23).
Regarding claims 114-119, Macur teaches that filamentous fungi can comprise protein in “a range between 30 wt. % and 80 wt. or in any whole number percentage range between 30 wt. % and 80 wt”. Thus, the food products expressly taught in Macur are above the claimed amounts. The adjustment of concentrations of a cultured product to fall within any of the claimed ranges would be well within the level of ordinary skill in the art. Increasing the protein content would amount to routine optimization and adjustment of working conditions.
From the teachings of the cited references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as each reference pertains to fungal culturing techniques, both discus the co-culturing of fungus and bacteria, and one could have reasonably predicted that culturing a filamentous fungi with a cellulose-producing bacteria yields a pellicle harboring the consortium, including the whole protein derived from the fungi.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 99-119 are rejected under 35 U.S.C. 103 as being unpatentable over Macur et al. (US PGPub 20200270559) and Lu et al. (WO2021035115), as applied to claims 99-101 and 107-119 above, and further in view of “Edwards” (Edwards DG, Cummings JH. The protein quality of mycoprotein. Proceedings of the Nutrition Society. 2010;69(OCE4):E331. doi:10.1017/S0029665110001400) (to include the rejections of claims 102-106).
The combined teachings of Macur and Lu make obvious a composition comprising a bacterial-derived cellulose scaffold including a filamentous fungi having a whole protein and a cellulose-producing bacteria.
However, the teachings of Macur and Lu do not explicitly teach that the whole protein has a digestibility amino acid score of greater than 0.8, 0.85, 0.9, or 0.95.
Edwards teaches that a mycoprotein food ingredient produced by the continuous fermentation of Fusarium venenatum possess a protein digestibility corrected amino acid score (PDCAAS) of 0.996 (see the last paragraph: “Using this more cautious figure gives a PDCAAS of 0.996, confirming the high protein quality of mycoprotein.”). Edwards also teaches that mycoprotein products can form the central part of a main meal, so the protein provided is likely to be significant for some individuals, and therefore having a high protein digestibility score is critical (first paragraph).
Thus, to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, it would have been prima facie obvious to produce a whole-protein containing composition as claimed, wherein the composition comprises a consortium of a cellulose-producing bacteria and a filamentous fungi in a cellulose pellicle, as made obvious by the teachings of Macur et al. and Lu et al., and wherein the fungus-derived whole protein has a digestibility amino acid score of greater than 0.99 as taught in Edwards et al..
One would have been strongly motivated to include in a food product intended for protein replacement a filamentous fungi that produces a high quality protein product, including the Fusarium sp. protein with a PDCAAS score of higher than 0.95, as demonstrated in Edwards. The selection of a useful edible fungal species known to provide high quality protein would have been a matter of judicial selection to one of ordinary skill, in view of the cited art teachings.
Based on all the cited teachings of Edwards, Macur, and Lu, there would have existed a reasonable expectation of success into doing so because the high digestibility of these fungus proteins is demonstrated in the art, and such filamentous fungi are explicitly taught as suitable food replacements in both Edwards and Macur.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 99-101, 107-109, and 111-115 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-11, and 29 of U.S. Pat. No. 11,918,020.
Claims 99-101 and 107-112 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 18, and 21-24 of U.S. Pat. No. 11,986,001.
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter recited in the claims of the issued patents renders obvious the claims of the instant invention.
Claim 1 of the ‘020 patent recites a method of producing an edible pellicle comprising: (a) preparing a fermentation culture by combining, in a fermentation vessel: (i) one or more filamentous fungi; (ii) one or more cellulose-producing bacteria; and (iii) a culture medium; (b) incubating the culture under culture conditions for a time sufficient to produce a pellicle comprising a bacterial cellulose scaffold and fungi mycelia embedded in the scaffold, wherein the pellicle comprises at least 5% fungal protein by dry weight and at least 5% fiber by dry weight; (c) killing the bacteria and fungi in the pellicle to produce an edible pellicle; and (d) harvesting the edible pellicle, wherein the edible pellicle is not dehydrated.
Similarly, claim 1 of the ‘001 patent recites a method of producing a bacterial cellulose composition, comprising: preparing a microbial consortium fermentation culture comprising:
(i) one or more filamentous fungi; (ii) one or more cellulose-producing bacteria; and (iii) a culture medium; incubating the culture for a time sufficient to produce a bacterial cellulose composition; and harvesting the bacterial cellulose composition, wherein the bacterial cellulose composition is not dehydrated.
The reference claims do not explicitly recite that there is a “whole-protein”, however the issued patents are drawn to using the same fungal species, which would predictably yield protein compositions identical, or nearly identical to, the instantly claimed compositions.
Therefore, in view of the claimed subject matter of both of the reference patent, performing the methods disclosed therein would produce a composition which either anticipates or clearly makes obvious the instantly-claimed composition, comprising a whole-protein and a cellulose scaffold, produced by a microbial consortium comprising:(i) one or more filamentous fungi; and(ii) one or more cellulose-producing bacteria.
The whole-protein is obtained from the cocultured filamentous fungi and the cellulose-producing bacteria and would therefore be inherently present in the edible pellicle recited in the claims of the reference patents 11,918,020 and 11,986,001.
Regarding the instant claims 100 and 101, claim 1 of the ‘020 patent recites that the bacteria and fungi is killed, while claim 2 of the ‘001 patent requires this. Further, claim 1 of both of the reference patents recites that the wherein the edible pellicle (i.e. the bacterial cellulose) composition is not dehydrated.
Regarding the instant claim 107, claim 8 of the ‘020 patent and claim 4 of the ‘001 patent each recites that the one or more bacteria comprise one or more of Komagataeibacter, Acetobacter, and Gluconacetobacter
In regards to claim 108, claims 9-10 of the ‘020 patent and claims 5-6 of the ‘001 patent recite that the one or more filamentous fungi comprise one or more of Aspergillus, Neurospora, and Fusarium.
Regarding claim 109, claim 11 of the ‘020 patent and claim 7 of the ‘001 patent each recites that the microbial consortium comprises Komagataelbacter and Aspergillus.
Regarding claim 110, claim 10 of the ‘001 patent recites that the microbial consortium further comprises one or more yeast, which, when one turns to the specification to determine the intended limits and meanings of the element, clearly encompasses the exemplary yeast Saccharomyces cerevisiae (see [0042]). MPEP §804.II.B.1. establishes that "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004);” and also describes that “the portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. Thus, the inclusion of a Saccharomyces yeast, as in the instant claim 110, would be obvious over the subject matter claimed in the ‘001 patent.
Regarding claims 111 and 112, the claims of the reference patents both disclose that the edible pellicle (i.e. the cellulose containing composition) may be shaped into various shapes, including food product shapes. Claim 3 of the ‘020 patent and claim 21 of the ‘001 patent recites that the edible food article or pellicle is shaped into a strip, a ring, a disk, a log, a crescent, a fan, a rectangle, a triangle, a medallion, or a slab. Claim 4 of the ‘020 patent and claims 22-25 of the ‘001 patent each recite that the product is in the shape of various food products, including seafood products, a patty, or a nugget.
Regarding claims 113, 114, and 115, claim 1 of the ‘020 patent recites that the pellicle comprises at least 5% fungal protein by dry weight and at least 5% fiber by dry weight; while claim 29 of the ‘020 patent further limits the pellicle to comprising at least 10% fungal protein by dry weight and at least 10% fiber by dry weight.
Therefore, the claims of the instant invention are not patentably distinct from the cited reference patents because practicing at least one of the reference patent methods (which are essentially identical in scope) would result in a product that is not patentably distinguishable from that instantly claimed, which are at least obvious variants of the edible pellicles of the reference patents. All of the additional limitations are either referenced directly or clearly obvious over the prior patented claims.
Claims 113-119 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-11, and 29 of U.S. Patent No. 11,918,020 and as being unpatentable over claims 1-10, 18, and 21-24 of U.S. Patent No. 11,986,001, each in view of Macur et al. (US PGPub 20200270559 to Sustainable Bioproducts, Inc).
The claims of the 11,918,020 patent do not explicitly teach that the method results in an edible pellicle having greater than 20% protein by weight. The claims of the 11,986,001 patent do not particularly point out that the bacterial cellulose composition has a fiber content of at least 5% and a protein content of greater than 5%. However, these additional nutritional limitations of the composition would have been prima facie obvious over the teachings of the art.
The relevant teachings of Macur et al. (‘559) include all of those discussed above. Macur pertains to edible filamentous fungal biomat formulations provided as protein sources and/or protein ingredients in foodstuffs (Title, Abstract). Macur teaches methods associated therewith, foodstuffs containing edible filamentous fungi, and methods and uses thereof ([0002]). Macur teaches that only certain protein food sources are “complete” proteins, meaning that they contain all of the essential amino acids (thus “whole-protein”, as best understood from the instant specification) ([0004]). Macur teaches that one source of complete protein can be obtained from edible filamentous fungi, such as Fusarium venenatum ([0005]).
Regarding claim 113, Macur teaches that a product including the filamentous fungi Fusarium strain MK7 has a total fiber content of 23.3% and one made from Fusarium venenatum has a total fiber content of 25.1% (see [0364]-[0366], Example 23). Regarding claims 114-119, Macur teaches that filamentous fungi can comprise protein in “a range between 30 wt. % and 80 wt. or in any whole number percentage range between 30 wt. % and 80 wt”. Specific examples given in Macur include products with greater than 50% protein (see [0364]-[0366] and [0182]). Thus, the food products expressly taught in Macur are above the claimed amounts.
From the teachings of the cited reference Macur, it would have been prima facie obvious to one having ordinary skill in the art to adjust the fiber content and protein contents to desirable amounts when producing the cellulose-containing compositions made obvious by the subject matter in the ‘020 and ‘001 reference patents.
The adjustment of concentrations of a cultured product to fall within any of the claimed ranges would be well within the level of ordinary skill in the art. Increasing the protein content would amount to routine optimization and adjustment of working conditions. It is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as each reference pertains to bacterial and fungal culturing techniques, and one could have reasonably predicted that culturing a filamentous fungi with a cellulose-producing bacteria yields a pellicle harboring the consortium, including a product having a high amount of a whole protein derived from the fungi, as taught in Macur.
For these reasons, the products of the instant claims 113-119 would have been prima facie obvious over the subject matter of the reference patents, in view of Macur.
Claims 102-106 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-11, and 29 of U.S. Patent No. 11,918,020 and over claims 1-10, 18, and 21-24 of U.S. Patent No. 11,986,001, each in view of “Edwards” (Edwards DG, Cummings JH. The protein quality of mycoprotein. Proceedings of the Nutrition Society. 2010, of record).
The subject matter of the cited reference claims (in the ‘020 and ‘001 patents) make obvious a composition comprising a bacterial-derived cellulose scaffold including a filamentous fungi having a whole protein and a cellulose-producing bacteria.
However, the claims from the reference patents do not explicitly teach that the whole protein has a digestibility amino acid score of greater than 0.8, 0.85, 0.9, or 0.95.
Edwards discusses a mycoprotein food ingredient produced by the fermentation of Fusarium venenatum which possess a protein digestibility corrected amino acid score (PDCAAS) of 0.996 (see the last paragraph: “Using this more cautious figure gives a PDCAAS of 0.996, confirming the high protein quality of mycoprotein.”). Edwards teaches that mycoprotein products may form the central part of a main meal, so therefore having a high protein digestibility score is critical (first paragraph).
Thus, to one of ordinary skill in the art it would have been prima facie obvious to produce a whole-protein containing composition as claimed, wherein the composition comprises a consortium of a cellulose-producing bacteria and a filamentous fungi in a pellicle, as taught in the claims of the reference patents ‘020 and ‘001, such that the fungus-derived whole protein has a digestibility amino acid score of greater than 0.99 as taught in Edwards.
One would have been motivated to include in an edible product intended for protein replacement a filamentous fungi that produces a high quality protein product, including the Fusarium sp. protein with a PDCAAS score of higher than 0.95, as demonstrated in Edwards. The selection of a useful edible fungal species known to provide high quality protein would have been a matter of judicial selection to one of ordinary skill, in view of the cited art teachings.
Based on the cited t