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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10 December 2025 has been entered.
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 13 June 2025.
CLAIMS UNDER EXAMINATION
Claims 15, 18-23, 26-28, 30-34 and 36 are pending and have been examined on their merits.
PRIORITY
Provisional Application 62/701,906, filed on 23 Jul 2018, is acknowledged. The Provisional Application does not provide support for a “thickness direction being defined by a growth direction of the matrix of mycelium fibers and having a smaller dimension that a perpendicular dimension and a transverse dimension” as recited in claim 15. The specification filed on 23 July 2019 does not provide support for these limitations.
REJECTIONS
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15-16, 18-23, 26-28, 30-34 and 36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 15 has been amended to recite a “thickness direction being defined by a growth direction of the matrix of mycelium fibers and having a smaller dimension that a perpendicular dimension and a transverse dimension”. The arguments filed on12 December 2025 state support for this limitation “can be found within at least the figures and corresponding descriptions” of US Application 16/190585 (Patent US11266085), which is incorporated by reference. The Applicant does not point to any specific drawings or sections of the disclosure.
A search of the instant specification, and the 16/190585 application, does not disclose a “thickness direction” defined by a “growth direction” having a smaller dimension than a perpendicular dimension and a transverse dimension. The terms “thickness direction” and “growth direction” are not disclosed. The term “transverse” does not appear in either disclosure. While the term “perpendicular” is present in the 16/190585 disclosure, it is in reference to the direction of “air flow”.
An amendment to the claims or the addition of a new claim must be supported by the description of the invention in the application as filed. In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989). Applicant is required to cancel the new matter in the reply to this Office Action.
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 15, 18-19, 21, 23, 26-28, 31-34 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Greetham et al. (previously cited; Mycological Biopolymers Gown In Void Space Tooling. US20150033620 published 05 February 2015) as evidenced by Carlton et al. (previously cited; US2022/0354068), Patel et al. (previously cited; Coleus Forskohlii 2022 pages 1-25), Hartl et al. (previously cited; Fungal chitinases: diversity, mechanistic properties and biotechnological potential. Appl Microbiol Biotechnol (2012)93:533–543) and Millipore (previously cited; chelators, pages 1-4).
Greetham teaches a mycological biopolymer product consisting entirely of fungal mycelium (Abstract). The material is “free of any stipe, cap, or spores” (see Abstract; see claim 1 of Greetham). The biopolymer product is undifferentiated (Abstract). As evidenced by Carlton et al. (US2022/0354068), US20150033620 (Greetham) discloses an undifferentiated aerial mycelium mycological biopolymer. Therefore the product taught by Greetham is an undifferentiated fungal aerial mycelium.
The mycological biopolymer material is used to make functional products ([0005]).
The art teaches environmental conditions that “accelerate tissue production” and prevent differentiation of the fungus into a mushroom ([0012]). Therefore the product is a tissue.
The instant specification identifies an 18-inch by 11-inch by 2.5-inch piece of mycological biopolymer as being a panel ([0026]). Therefore a panel is broadly interpreted to be a rectangle. Greetham uses a rectangular shaped tool to produce the biopolymer (see Figure 4). Therefore the art is interpreted to produce a panel.
The art teaches a horizontal tool to create a horizontal mycelium (Figure 6B). The art teaches the structure making up the horizontal mycelium (FIG. 6B) is extremely aligned with a highly oriented network. These morphological differences have a great effect on the material properties of biopolymer produced. The horizontally grown biopolymer has greater tensile strength in the direction of growth ([0090]).
The instant specification discloses the mycological biopolymer panel is formed by growth under humidity, temperature, carbon dioxide and oxygen sufficient to produce a mycelium biopolymer while preventing full differentiation (see page 2 last two lines bridging first two lines of page 3; also see last paragraph of page 4 bridging first paragraph of page 5). 16/190585 (Patent US11266085), which is incorporated by reference, discloses growth using 5% carbon dioxide content and a temperature of 85-90°F. The Application discloses US 2015/0033620 (Greetham) uses these conditions (see column 1, lines 12-17 of Patent US11266085). 16/190585 (Patent US11266085), discloses the growth conditions that prevent full differentiation.
Greetham teaches the environmental conditions for producing the mycological biopolymer product include high carbon dioxide content from 5-7% by volume and elevated temperature (from 80° to 95° F) to prevent full differentiation of the fungus into a mushroom (Abstract; [0012] [0045]). Therefore the biopolymer taught by Greetham is made using the same conditions.
While Greetham teaches inoculation with a nutritive substrate, the product is extracted from the substrate (Abstract). Therefore the product does not comprise any growth media.
Morphological modifiers may be sprayed onto the surface of the biopolymer or misted in the environment to alter the morphology of the mycelia, for example using hormones, forskolin, calcium, calcium blockers (cobalt chloride) ([0061] [0096]). Forskolin acts by activating that production of cAMP in the cell that triggers a signaling cascade, which increases the branching, or cross-linking, of the material. As evidenced by Patel, forskolin is derived from a plant, has a sweet aroma and a bitter taste. Therefore the art is broadly interpreted to teach a plant-derived flavoring ingredient (see page).
It would have been obvious to add forskolin to the biopolymer. One would have been motivated to do so to alter the morphology of the mycelia, as taught by Greetham. KSR Rationale E indicates that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and commonsense” (MPEP 2143 “Rationale E. Obvious to Try” section). One would have had a reasonable expectation of success since Greetham teaches it can be done.
Claim 15 recites the orientation defined by a “growth direction” of the product. Greetham teaches an undifferentiated mycelium without stipe, cap or spores that is produced using the conditions disclosed in the specification. Therefore the matrix of mycelium fibers would be expected to have the characteristics recited in claim 1. Any slight variation would be rendered obvious. See MPEP 2113 II. Once a product appearing to be substantially identical is found and a prior art rejection is made, the burden shits to the Applicant to show a nonobvious difference. Because the art teaches a mycological biopolymer panel that reads on the claim, it is suitable for use as a foodstuff. Therefore claim 15 is rendered obvious.
Greetham teaches water can be added ([0034]). As evidenced by Millipore, water is a natural chelator (see page 1). Therefore water reads on claims 18-19.
Forskolin is broadly interpreted to read on an aromatic since it has a sweet smell. Therefore claim 21 is included in this rejection.
The art teaches various morphological modifiers may be sprayed onto the surface of the biopolymer or misted in the environment to alter the morphology of the mycelia, for example calcium ([0061] [0096]). Calcium is a mineral. Therefore claim 23 is included in this rejection.
Greetham teaches the product of the invention literally grows itself, using little to no energy to produce the biopolymer apart from the energy used in sterilization, growth conditions, and drying ([0009]). Therefore the art suggests sterilization. A sterilized product reads on the limitations recited in claim 26.
Because the biopolymer taught by Greetham reads on the undifferentiated aerial mycelium with well-aligned macromolecular structures recited in claim 15, it would be expected to have the properties recited in claims 27-28.
As evidenced by Hartl et al., chitinases are naturally occurring enzymes found in fungi (see Abstract). Therefore chitinases would be present in the fungi taught by Greetham. Therefore claims 31-32 are included in this rejection.
After drying the art teaches the product can be sanded, cut or milled to shape. Cutting is interpreted to read on trimming. Therefore claim 33 is rendered obvious.
Greetham teaches calcium can be added to the product (supra). Therefore it is an additive. Claim 34 recites an “animal-derived additive”. This is a product by process limitation that does not distinguish the claimed additive from the calcium additive taught by the art. Therefore claim 34 is included in this rejection.
The art teaches the product is treated to increase strength and density ([0064]). The art teaches compressing the biopolymer material to the desired dimensions and density or 3D shape and incubated for an additional 0 to 72 hours to increase strength and density ([0064]). Therefore one would optimize the incubation time to achieve the desired density. Therefore claim 36 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
APPLICANT’S ARGUMENTS
The arguments made in the response filed on 10 December 2025 are acknowledged. The Applicant argues Greetham does not teach fibers oriented in a “thickness direction” and “growth direction” as now claimed. The Applicant argues Figures 6A (vertical mycelium) and 6B (horizontal mycelium) does not disclose the orientation as recited in claim 15.
EXAMINER’S RESPONSE
The arguments are not persuasive. The instant specification discloses the claimed product is formed by growth under humidity, temperature, carbon dioxide and oxygen sufficient to produce a mycelium biopolymer while preventing full differentiation (see page 2 last two lines bridging first two lines of page 3; also see last paragraph of page 4 bridging first paragraph of page 5).
Greetham teaches differentiation is prevented. Greetham teaches the environmental conditions for producing the mycological biopolymer product include high carbon dioxide content from 5-7% by volume and elevated temperature (from 80° to 95° F) to prevent full differentiation of the fungus into a mushroom (Abstract; [0012] [0045]). Greetham teaches the relative humidity, temperature, carbon dioxide and oxygen levels are manipulated on the surface of the matrix allowing for the production of the mycological biopolymer ([0093]). Because the art teaches the method of growth disclosed in the specification, it would be expected to produce a product with a thickness direction and growth direction as now claimed. The Applicant has provided arguments, but no evidence demonstrating a non-obvious difference between the claimed product and that taught by the prior art. The burden is shifted to Applicant to provide evidence of a non-obvious difference (see MPEP 2113 II).
Claims 20, 22 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Greetham as applied to claim 15 above, and further in view of Kozubal et al. (Edible foodstuffs and bioreactor design. US2022/0400726 with benefit of 16/116836 filed on 29 August 2018 now Patent 1144251) as evidenced by Wrona et al. (previously cited; 10 Powerful Nutrients Found Only in Meat. 09 June 2022).
Claim 15 is rejected on the grounds set forth above. The teachings of Greetham are reiterated.
The art is silent regarding the use of a colorant (claim 20).
Greetham does not teach the use of heme molecules (claim 22).
Greetham is silent regarding the presence of pin holes (claim 30).
Kozubal et al. disclose a food material comprising fungal mycelium and animal meat (see claim 1 of Kozubal). Kozubal teaches the fungal mycelium comprises aerial hyphae (see claim 13 of Kozubal). The art teaches the use of color additives ([0097]).
It would have been obvious to add a colorant to the composition taught by Greetham. One would have been motivated to do so since Greetham teaches a mycelial composition and Kozubal teaches colorants can be added to mycelial compositions. One would add color when formulating into a meat like product, as taught by Kozubal. One would have had a reasonable expectation of success since Kozubal teaches colorant can be added to compositions comprising fungal mycelium. One would have expected similar results since both references are directed to products made of aerial mycelium Therefore claim 20 is included in this rejection.
Kozubal teaches the composition comprises animal meat. As evidenced by Wrona et al., animal meat contains heme iron (see page 13).
It would have been obvious to combine animal meat with the composition taught by Greetham. One would have been motivated to do so since Greetham teaches a mushroom product and Kozubal teaches adding meat (containing heme) to a mushroom product. One would do so when using the mushroom product as a food. One would have had a reasonable expectation of success since Kozubal teaches meat can be added to a product containing aerial mycelium. One would have expected similar results since both references are directed to products made of aerial mycelium. Therefore claim 22 is included in this rejection.
Kozubal teaches perforation with a fork, knife or other tenderizer tool ([0185]). Perforation with a fork is broadly interpreted to produce an array of pin holes.
It would have been obvious to perforate the product taught by Greetham with pin holes. One would have been motivated to do so since Greetham teaches a mushroom product and Kozubal teaches perforating a mushroom product. One would do so when using the mushroom product as a food as taught by Kozubal. One would have had a reasonable expectation of success since Kozubal teaches products containing aerial mycelium can be perforated. One would have expected similar results since both references are directed to products made of aerial mycelium. Therefore claim 30 is included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 270-8439.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NATALIE M MOSS/ Examiner, Art Unit 1653