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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/31/2026 has been entered.
Response to Amendment
Applicant's amendment and argument filed 08/31/2026 in response to the final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1, 4, 7, 9-19, 21, 24-27 and 29-31 are pending of which claims 17-19, 21, 24-27 and 29-30 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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
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 processing the composition of claim 1, and the claim limitation is confusing as to what the metes and bounds are for the term processing. What needs to happen for this limitation to be met? Is the applicant trying to limit the product to a product by process for creating the composition and if so by including what steps? The claim is indefinite.
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.
This rejection is maintained due to the amendments and arguments filed on 08/31/2026. Claims 1, 4, 7, 9-16 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. Another consideration is the claimed heat treatment, chemical treatment and/or lyophilization treatment. When claimed as an option and when claimed so broadly there is no requirement for any specific chemical or range of temperature from the heat treatment that would necessarily change the structural components of the cells. For instance, not all chemicals will change the function and/or structure of a cell, and neither would any temperature of heat.
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
Applicant's arguments filed the 08/31/2026 have been fully considered but they are not persuasive. The applicant argues that incorporating claim 6 that was previously not included in the 101 rejection would render the claim rejection moot. On second consideration the claim limitations would not overcome the rejection because of the claimed heat treatment, chemical treatment and/or lyophilization treatment. When claimed as an option and when claimed so broadly there is no requirement for any specific chemical or range of temperature from the heat treatment that would necessarily change the structural components of the cells.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4, 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 08/31/2026.
Regarding claims 1, 4 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 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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Eben Bayer et. al. (US20200157506A1) as applied to claims 1, 4, 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 08/31/2026.
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
Applicant's arguments filed the 08/31/2026 have been fully considered but they are not persuasive. The applicant argues that Bayer does not teach or suggest a composition comprising of a fungal pellet and animal cells, wherein the fungal pellet is a filamentous biomass providing a 3-dimensional surface for the growth of the animal cells, wherein the animal (presumably fungal) cells are selected from Aspergillus sojae, Aspergillus awamori, Aspergillus oryzae, Aspergillus tubingensis, Aspergillus nishimurae, Penicillium chrysogenum and combinations thereof. Bayer indeed teaches each limitation except for the species of fungus, and the Office relies on Patillo to teach the species as being Aspergillus oryzae.
The applicant argues that Patillo teaches fermented shelf-stable protein food ingredients. The shelf-stable protein food ingredients can comprise fungi cultivated in optimized fermentation systems. Pattillo teaches growing filamentous fungal mycelium separately and then adding or blending it with meat products (such as chicken). It would have been obvious to a person having ordinary skill in the art to look to Pattillo and select a fungal species which would be compatible in Bayer’s composition. The species are both taught to be used in creating food compositions from fungal species and there would have been a reasonable expectation of success in arriving at the instant invention given the relied upon art.
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 BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
