CTFR 18/504,646 CTFR 95735 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Response to Amendment Applicant's amendment and argument filed 04/08/2026 in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn. 08-06 AIA Claim s 1, 4-7, 9-27 and 29-31 are pending of which claims 17-27 and 29-30 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/19/202 Claims 1, 4-7, 9-16 and 31 are being examined on the merits . Claim Rejections - 35 USC § 112 07-30-02 AIA 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. Claim 31 is 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. Claim 31 recites an edible composition made by the processing according to claim 1, however there is no processing required of claim 1 which renders the claim limitation confusing and indefinite and lacks antecedent basis. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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. This rejection is maintained due to the amendments and arguments filed on 04/08/2026. Claims 1-5, 7-16 and 31 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. Response to Arguments 07-37 AIA Applicant's arguments filed 04/08/2026 have been fully considered but they are not persuasive. The applicant argues that since the fungal pellet requires processing by a human that this somehow overcomes the 101 rejection. Just because the pellet requires processing does not mean that it cannot be found in nature. The applicant only claims a fungal pellet and animal cells and wherein the animal cells or a portion thereof are located on an exterior surface of the fungal pellet, an interior or both. Fungal pellets are merely aggregates of fungal hyphae and these can indeed be found contacting animal cells on their exterior. The applicant argues that somehow the viability of C2C12 cells on various fungal microcarriers after 3 days of cultivation supports a markedly different characteristic. It is not understood what the viability of C2C12 cells has to do with the judicial exceptions being markedly different from their counterparts. The applicant argues that the individual fungal pellets and animal cells on their own would not be able to form scalable meat production. The animal cells and the fungal pellet, on their own would not have to form scalable meat products in order for the claims as currently written to be rejected. The applicant is only claiming fungal cells and animal cells being in contact with each other and nothing more. Fungi are ubiquitous in nature and are indeed found growing even on animal cells . Claim Rejections - 35 USC § 103 07-103 AIA The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. 07-21-aia AIA Claim s 1-7, 9-16 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Eben Bayer et. al. (US20200157506A1). This rejection is maintained with slight modifications due to the amendments and arguments filed on 04/08/2026 . 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). Bayer also teaches wherein “if a solid substrate or surface is included in the vessel, the three-dimensional filamentous network will develop with attachment to the surface” (see 0031). Bayer also claims “delivering a flow of beef myocytes into said decellularized filamentous scaffold for attachment to and in said filamentous scaffold to form a composite mass of hyphae and myocytes; 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 mm 3 to 0.018 mm 3 , 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 mm 3 to 0.018 mm 3 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 . 07-22-aia AIA Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Eben Bayer et. al. (US20200157506A1) as applied to claim s 1-7, 9-16 and 31 above, and further in view of Augustus H. Pattillo (US11470871B2). This rejection is maintained with slight modifications due to the amendments and arguments filed on 04/08/2026 . 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 . Response to Arguments 07-37 AIA Applicant's arguments filed 04/08/2026 have been fully considered but they are not persuasive. The applicant argues that persons having skill in the art would not turn to Pattillo to select a species of filamentous fungi to use in the composition taught by Bayer because Pattillo’s art is directed to creating shelf-stable protein food ingredients and because Bayer’s is directed to a method of generating a mycelial scaffold comprising placing a substrate of nutritive substrate and a fungus in a defined environment etc. The applicant argues that persons having ordinary skill would not expect the fungal species of Pattillo to be functional in the same sense as the fungal species of Bayer. The applicant makes this argument however does not articulate any reason for this to be the case or show any evidence to support this statement. The filamentous fungi would merely be expected to grow and the expectation for this happening would be expected as Bayer teaches growing filamentous fungi in a bioreactor with culture support and substrate support. There is no reason that one would not expect the species taught in Pattillo to not grow as argued by the applicant. The applicant argues that Pattillo is not directed to creating support scaffolding for growing non-filamentous organisms into the filamentous scaffold. Pattillo’s invention does not have the be the same as the applicant’s to be relied upon. The applicant argues that the unexpected results of cultivating of A. oryzae with bESC cells are not obvious but once again does not articulate why these results would be unobvious or unexpected. Merely stating so does not make it so. Fungi are known to grow on substrates and cells are also known to grow where nutrients are supplied. Additionally, the claims being examined are to a composition and not a method of culturing cells or biomass on fungal components as what is being argued. The process of acquiring the composition is not being examined . The applicant argues that Bayer teaches that the scaffold remains part of the formed tissue throughout the intended usable life of the tissue. Bayer teaches delivering a flow of beef myocytes into said decellularized filamentous scaffold for attachment to and in said filamentous scaffold to form a composite mass of hyphae and myocytes. This would teach that the animal cells are in in the interior of the fungal pellet. Conclusion Currently no claims are allowed. 07-40 AIA Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL . See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. JACOB A BOECKELMANExaminer, Art Unit 1655 /ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655 Application/Control Number: 18/504,646 Page 2 Art Unit: 1655 Application/Control Number: 18/504,646 Page 3 Art Unit: 1655 Application/Control Number: 18/504,646 Page 4 Art Unit: 1655 Application/Control Number: 18/504,646 Page 5 Art Unit: 1655 Application/Control Number: 18/504,646 Page 6 Art Unit: 1655 Application/Control Number: 18/504,646 Page 7 Art Unit: 1655 Application/Control Number: 18/504,646 Page 8 Art Unit: 1655 Application/Control Number: 18/504,646 Page 9 Art Unit: 1655 Application/Control Number: 18/504,646 Page 10 Art Unit: 1655 Application/Control Number: 18/504,646 Page 11 Art Unit: 1655 Application/Control Number: 18/504,646 Page 12 Art Unit: 1655
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