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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 11/19/2025 is acknowledged.
Claims 17-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/19/2025.
Claims 1-16 are being examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 23, 2024 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Drawings
The drawings were received on November 8, 2023. These drawings are acceptable.
Claim Objections
Claims 3-16 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims 3-16 would not have been further treated on the merits. However, the claims have been interpreted as containing the dependent limitation and have been examined further below based on this claim interpretation.
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 1-5 and 7-16 are rejected under 35 U.S.C. 101 because the claimed composition is directed to a product of nature without significantly more. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since the claim is directed to a composition comprising a composition comprising fungal and animal cells the claim is a composition of matter. Step 2A prong one of the analyses evaluates whether the claim is a judicial exception (see MPEP 2106.04). Because the claim states the nature-based products fungal and animal cells the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within animals and fungi. Animal and fungal cells are cells of different organisms and are the judicial exceptions. The animal and fungal cells being claimed are no different than their counterparts found existing in nature. The applicant is merely claiming these components together in a composition which is not enough to overcome the 101 rejection. These cells have the same properties, functions and structural components of their natural counterparts and are therefore no different than claiming what exists in nature. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found within the plants they come from.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. This judicial exception is not integrated into a practical application because the claims are only directed to a composition comprising the fungal and animal cells.
Doing so would be implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature and the addition of an intended use does not impart any added benefit to the compounds or integrate the composition into a practical application.
Step 2 B evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05(b)). The claims also recite different species and further limit the size of the fungal pellet (cells) which does not amount to significantly more than the recited exceptions. Claiming these cells together is also taken into consideration however fungal cells are indeed found coexisting with, in and on animal cells in their natural environment.
Please also note, the mere modifying the concentration and proportions of the product/composition is not sufficient to remove the claimed composition from a judicial exception.
Therefore, admixing the claimed naturally-occurring ingredients at such a high degree of generality merely involves applying the natural principal and appears to be no more than a drafting effort to claim the judicial exception itself; a mixture of naturally-occurring components that is not markedly different from its’ closest-occurring natural counterpart and which does not offer significantly more than the judicial exception.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-7, 9-14 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eben Bayer et. al. (US20200157506A1).
Regarding claims 1, 4-5 and 16, Bayer describes a method of generating a mycelial scaffold comprising the steps of placing a substrate of a nutritive substrate and a fungus in a defined environment with a temperature of from 85° F. to 95° F. and a carbon dioxide content of from 3% to 7% of the environment; said fungus characterized in being a. biocompatible species; incubating said substrate in said environment to induce mycological biopolymer growth from said substrate without producing a stipe, cap or spore therein; and removing the growth of mycological biopolymer from said substrate as a one piece self-contained billet (see claim 1).
A method as set forth in claim 1 wherein said fungus is a filamentous organism and which further comprises the step of introducing a non-filamentous organism into said substrate for incubation and co-cultivation of said filamentous organism and said non-filamentous organism into said billet (see claim 2).
A method as set forth in claim 2 wherein said non-filamentous organism is a chordate myocyte of one of a bovine, avian and fish cell line (see claim 3). This would describe creating the instant composition wherein animal cells are in connection with the fungal pellet and wherein the fungal pellet is inviable and wherein the fungal cells are intact fungal cells.
Regarding claim 6, Bayer discloses wherein filamentous scaffold is removed from final tissue using thermochemical applications (see 0231) and with the broadest reasonable interpretation of “heat-treated” and “chemically-treated” this would be the same as either/both.
Regarding claim 7, Bayer discloses wherein the filamentous organism is saprophytic fungus of the genus Rhizopus (see claim 5).
Regarding claims 9-10 and 12, Bayer discloses wherein the animal cells are mammalian and non-human (see 0012, claim 12) as Bayer discloses the cells to be cow myocytes.
Regarding claim 11, Bayer discloses wherein the cells can be fish (see 0067).
Regarding claim 13, Bayer discloses wherein the generally considered safe for human consumption (see 0064).
Regarding claim 14, Bayer discloses wherein the fungal rhizomorphs are ranging from less than 1mm in diameter to 5 mm (see 0201), wherein 1mm diameter would anticipate the instant size range since the range encompasses this size.
Regarding claim 16, Bayer discloses the product as “foodstuff” (see 0017).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-7and 9-16 are rejected under 35 U.S.C. 103 as being unpatentable over Eben Bayer et. al. (US20200157506A1).
Regarding claims 1, 4-5 and 16, Bayer describes a method of generating a mycelial scaffold comprising the steps of placing a substrate of a nutritive substrate and a fungus in a defined environment with a temperature of from 85° F. to 95° F. and a carbon dioxide content of from 3% to 7% of the environment; said fungus characterized in being a. biocompatible species; incubating said substrate in said environment to induce mycological biopolymer growth from said substrate without producing a stipe, cap or spore therein; and removing the growth of mycological biopolymer from said substrate as a one piece self-contained billet (see claim 1); see pellet (0096).
A method as set forth in claim 1 wherein said fungus is a filamentous organism and which further comprises the step of introducing a non-filamentous organism into said substrate for incubation and co-cultivation of said filamentous organism and said non-filamentous organism into said billet (see claim 2).
A method as set forth in claim 2 wherein said non-filamentous organism is a chordate myocyte of one of a bovine, avian and fish cell line (see claim 3). This would describe creating the instant composition wherein animal cells are in connection with the fungal pellet and wherein the fungal pellet is inviable and wherein the fungal cells are intact fungal cells.
Regarding claim 6, Bayer discloses wherein filamentous scaffold is removed from final tissue using thermochemical applications (see 0231) and with the broadest reasonable interpretation of “heat-treated” and “chemically-treated” this would be the same as either/both.
Regarding claim 7, Bayer discloses wherein the filamentous organism is saprophytic fungus of the genus Rhizopus (see claim 5).
Regarding claims 9-10 and 12, Bayer discloses wherein the animal cells are mammalian and non-human (see 0012, claim 12) as Bayer discloses the cells to be cow myocytes.
Regarding claim 11, Bayer discloses wherein the cells can be fish (see 0067).
Regarding claim 13, Bayer discloses wherein the generally considered safe for human consumption (see 0064).
Regarding claim 14, Bayer discloses wherein the fungal rhizomorphs are ranging from less than 1mm in diameter to 5 mm (see 0201), wherein 1mm diameter would anticipate the instant size range since the range encompasses this size.
Regarding claim 16, Bayer teaches the product as “foodstuff” (see 0017).
Bayer does not specifically teach that the animal cells are located on the exterior surface or interior of the fungal pellet, or the specifically teach the size of the pellet as between 0.013 mm3 to 0.018 mm3, however Bayer teaches the scaffold remains part of the formed tissue throughout the intended usable life of the tissue (see 0231), teaches the filamentous fungi to be cocultured with the animal cells and that the pellets bind together through filamentous extension into a cohesive mass of the given geometry with beef myocytes. Therefore it would be obvious to persons having skill in the art before the effective filing date and/or expected that the filamentous fungal pellet to be on the interior and/or exterior of the animal cell as being claimed.
It would have also been obvious to create fungal pellets between 0.013 mm3 to 0.018 mm3 because pellets form in three dimensions and Bayer teaches wherein the size can be less than 1 mm and thus creating pellets within this size is mere matter of judicious selection and an optimization any person having skill could do without any undue experimentation.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Eben Bayer et. al. (US20200157506A1) as applied to claims 1-7 and 9-16 above, and further in view of Augustus H. Pattillo (US11470871B2).
Bayer teaches the instant invention, however is silent on the fungal species being one selected from claim 8.
Pattillo’ s general disclosure is to enhanced aerobic fermentation methods for producing edible fungal mycelium blended meats and meat analogue compositions (see abstract).
Pattillo teaches a method of producing a meat analogue food product from a filamentous fungal mycelium (see claim 1), wherein the filamentous fungal species can be Aspergillus oryzae (see examples 3, 5, 10).
Therefore it would be obvious to persons having skill in the art before the effective filing date to select Aspergillus oryzae as a filamentous fungal species for the composition taught by Bayer, because this species is taught for being useful for the same purpose. Combining prior art elements according to known methods to yield predictable results and combining equivalents known for the same purpose is prima fascia obvious.
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655