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 Invention I (claims 1-17) in the reply filed on 12/10/2025 is acknowledged.
Claims 18-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Accordingly, claims 1-17 have been examined on the merits.
Priority
The instant application claims the priority benefit of U.S. Provisional Application Nos. 63/421087 (filed on 10/31/2022) and 63318653 (filed on 3/10/2022) under 35 U.S.C. 119(e).
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 7/20/2023 and 12/13/2023 are in compliance with the provisions of 37 C.F.R. 1.97. Accordingly, all references cited in both IDSs have been fully considered.
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.
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 1-7, 10-13, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ross et al. (Pub. No. US 2018/0014468 A1).
According to Ross et al., filamentous fungi have the natural tendency to join together smaller pieces of branching, colonial hyphae into a larger constituent whole, assembling and weaving strands and sheets of tissues called mycelium. Mycelium can adhere to, and possibly engulf, any other materials it comes in contact with through the extension of hyphae that use neighbor sensing and searching functions as guidance in their exploration into space beyond sources of nutritional sustenance (par. [0004]). If provided adequate enclosure and environmental controls, a substrate colonized with fungal hyphae will generate a layer of fungal hyphae growing from the top of said substrate that will expand into space as a layer in a fuzzy and undifferentiated manner in one to three days (par. [0007]).
Ross et al. states that there is a need for a method of producing a fungal tissue material having variable thickness, density and other qualities for use by various industrial processes and applications. Such a method would include an intermediate layer placed upon a growing expression of hyphae from the surface of a colonized substrate. It would also further allow the manipulation of fungal materials to grow in particular and predetermined directions such as purposefully engineered structures, lattices, and other two or three-dimensional orientations of matter, as well as allow the formation of multiple sheets of fungal material which can be stacked or arranged in a continuous form (par. [0016]).
To address this need, Ross et al. discloses methods for growing a fungus polymer matrix using an inoculum of a desired fungal strain to inoculate a colonizable substrate, upon which an intermediate layer is placed to control the interaction of the forming fungal tissue structure with the substrate. Live fungal hyphae grow from the substrate and through the intermediate layer (par. [0017]). The hyphae can be stimulated or directed to fuse (i.e., forms a mycelium; par. [0170]-[0179]).
A preferred embodiment of the disclosed methods comprises: placing a nutritive vehicle that includes discrete particles and nutrients within an enclosure; inoculating the nutritive vehicle within the enclosure with a fungal inoculum comprising a desired fungal strain; placing an intermediate layer on the top surface of the nutritive vehicle; placing an optional additional material on top of the intermediate layer and/or mycelial layer, throughout which fungal material can grow to form a composite material; stimulating the growth of the fungal inoculum into a dense network of hyphae and allowing the hyphae to produce the fungal material on the nutritive vehicle and the intermediate layer; periodically manipulating the growth of the fungal material to grow the fungal material with desired characteristics; delaminating the intermediate layer from the nutritive vehicle to obtain a fungal material structure; and processing the fungal materials (par. [0132], [0134]).
Preferably, the fungal inoculum is a species of Ganodermas such as Ganoderma lucidum, Ganoderma tsugae, Ganoderma applanatum, Ganoderma resinaceum, and Ganoderma oregonense (par. [0136]).
Example 3 shows different embodiments of engineering the mycelium. One of them involves vertically depressing the mycelium to create void spaces and filling them with secondary material/additives and other fungal species. This alteration results in the production of a pattern on the vertical and horizontal aspects (par. [0280]; Figures 15A-15G).
Ross et al. is comparable to the instant application’s method of growing an aerial mycelium biopolymer for the following reasons:
Regarding claim 1: inoculating a nutritive vehicle comprising discrete particles with a fungal inoculum within an enclosure is equivalent to “providing an inoculated substrate, the inoculated substrate comprising: a first substrate; and a first spawn interspersed throughout the first substrate”.
The nutritive vehicle also comprising nutrients meets “the first spawn comprising a second substrate for fungal growth”, while the fungal inoculum comprising a desired fungal strain like Ganoderma lucidum (which produces aerial mycelium) satisfies the requirement that the first spawn comprises “a first fungus”.
The embodiment of creating void spaces throughout the outer surface of the inoculated nutritive vehicle and filling said void spaces with a secondary material/additive and other fungal species is analogous to “providing a second spawn comprising… a second fungus; and positioning the second spawn in a growth pattern approximately parallel to an outer surface of the inoculated substrate”.
Forming a pattern vertically and horizontally to control mycelial growth of the fungal strain and the other fungal species is the same as “wherein the growth pattern is configured to affect a growth topology of aerial mycelium growing from the first spawn and the second spawn”.
Using an intermediate layer on top of the inoculated nutritive vehicle to allow uniform growth and physical isolation of the fungal strain’s mycelium from the nutritive vehicle (par. [0144]-[0147]) and controlling the growth environment to maximize the production of mycelium (par. [0203]) fulfill the intended function of the claimed method to grow “an aerial mycelium biopolymer”, wherein the term “aerial mycelium” is defined by applicant as referring to “mycelium obtained from extra-particle aerial mycelial growth, and which is substantially free of growth matrix” (par. [0085], specification).
Ross et al. is different from the claimed invention in that it does not explicitly teach that the void spaces are filled with “a third substrate for fungal growth”.
Nonetheless, the prior art teaches filling the void spaces with a secondary material/additive and other fungal species (par. [0280]). Since the other fungal species would need nutrients for growth over a period of time (par. [0134]), a person with ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to also fill the void spaces with another nutritive vehicle comprising nutrients that support the growth of the other fungal species as the secondary material. It can be predicted that such modification would ensure that the other fungal species grows. The obviousness of the instant claim is based on some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP § 2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Claim 1 is thus obvious over Ross et al..
Regarding claim 2: the formed pattern producing an engineered mycelium of two different fungi in an organized manner corresponds to “wherein the growth pattern is configured to increase the homogeneity of the growth topology”.
Regarding claim 3: the inoculated nutritive vehicle comprising discrete particles which can be solid lignocellulosic material(s) like straw, hay, hemp, wool, cotton, rice hulls and/or recycled sawdust (par. [0134], [0189]) meets “wherein the first spawn comprises a solid fungal inoculum”.
Regarding claims 4-5: the prior art teaches depositing cellulose-based, synthetic or other organic fibers including various textile forms of preferred lengths and structural characteristics on the exposed surface of the growing fungal tissue, or 2D and 3D matrices on the surface or between layers of fungal material (par. [0164]-[0165]), is akin to “further comprising forming a layer of uninoculated substrate on at least one of the inoculated substrate and the second spawn, wherein the uninoculated substrate comprises a fourth substrate without substantially any fungus” and “wherein forming the layer of uninoculated substrate comprises forming a first layer of uninoculated substrate on the inoculated substrate and forming a second layer of uninoculated substrate on the second spawn”.
Regarding claim 6: the other fungal species being placed in the void spaces created on the outer surface of the inoculated nutritive vehicle satisfies “wherein positioning comprises positioning the second spawn directly onto the outer surface of the inoculated substrate”.
Regarding claim 7: the intermediate layer can be a membrane or fabric that is permeable to the growing fungal material (par. [0144], [0194]) and therefore fulfills “wherein the method further comprises providing a first topology adjustment layer, wherein the first topology adjustment layer comprises one or more openings”.
Regarding claim 10: the intermediate layer comprising openings and having a grid-like structure (par. [0210]; “204” in Figure 5A-5C) is the same as “wherein the one or more openings of the first topology adjustment layer comprise a plurality of holes in a grid pattern across the first topology adjustment layer”.
Regarding claim 11: the prior art teaches that other membranes, sheets, meshes, pellicles and tissues can be used as an intermediate layer (par. [0256]), thereby meeting the limitation “further comprising providing a second topology adjustment layer”.
Regarding claim 12: the intermediate layer being placed on the top surface of the inoculated nutritive vehicle, wherein said intermediate layer has openings that allow a dense network of hyphae to extend through and enable unform growth (par. [0144], [0210]), satisfies “wherein positioning further comprises positioning the first topology adjustment layer adjacent to the outer surface of the inoculated substrate, wherein one or more of the one or more openings of the first topology adjustment layer comprise perforations, and wherein the first topology adjustment layer is configured to allow for growth through the perforations and further affect the growth topology of aerial mycelium growing from the first spawn and the second spawn”.
Regarding claim 13: growing the fungi in a growth enclosure containing the nutritive vehicle and allows control of environmental factors like temperature, humidity, light levels, and CO2 and O2 concentrations in order to maximize the growth of mycelium (par. [0138], [0203]-[0206]) is analogous to “further comprising: placing the inoculated substrate and the second spawn into an incubation chamber; maintaining the incubation chamber with a predetermined growth environment of humidity, temperature, carbon dioxide content and oxygen content sufficient to produce an aerial mycelium biopolymer consisting essentially of fungal mycelium; and incubating the inoculated substrate and the second spawn in the incubation chamber for a period of time sufficient to produce the aerial mycelium biopolymer”.
Regarding claim 16: allowing the hyphae of the fungi to grow and extend through the openings of the intermediate layer is identical to “further comprising growing the aerial mycelium through the one or more openings of the first topology adjustment layer”.
Regarding claim 17: delaminating the intermediate sheet to dissociate the mycelium from the nutritive vehicle (par. [0018], [0212]) corresponds to “further comprising peeling the first topology adjustment layer to separate the aerial mycelium biopolymer from the inoculated substrate”.
Claims 1-7 and 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ross et al. (Pub. No. US 2018/0014468 A1) in view of Kaplan-Bie et al. (Pub. No. WO 2019/099474 A1).
The teachings of Ross et al. are set forth above and applied herein. Ross et al. is found to render claims 1-7, 10-13, and 16-17 obvious.
Ross et al. is similar to the claims below:
Regarding claim 14: the growth pattern having vertical and horizontal aspects is equivalent to “wherein the growth topology of aerial mycelium comprises a vertical growth topology and a horizontal growth topology”.
Ross et al. differs from the instant claim in that it does not explicitly teach “maintaining the carbon dioxide content within the incubation chamber at a level between about 0.6% to about 7% to affect the vertical growth topology of aerial mycelium”.
Kaplan-Bie et al., however, teaches a method of growing a biopolymer by incubating containers of growth media comprising nutritive substance and a fungus in a closed chamber. The closed chamber generates an airflow directed parallel or perpendicularly to the surfaces of the growth media while maintaining a predetermined environment of humidity, temperature, oxygen, and carbon dioxide (Abstract). The airflow provides a directed force that regulates the structure of the aerial mycelium and a consistent homogenization of the incubation environment (second par. in page 5). A vertical airflow, for example, leads to a morphology that is pulled upward (second par. in page 13). To grow the biopolymer material, the chamber is maintained at 5% CO2 (last par. in page 8; first par. in page 9). Given that Ross et al. aims to grow a mycelium in a controlled environment, it would have been obvious to use an incubation chamber such as Kaplan-Bie et al.’s closed chamber and expect that providing a vertical airflow and maintaining the CO2 concentration at 5% would help the fungi to grow a mycelium and affect its vertical growth topology.
Hence, claim 14 is obvious over Ross et al. in view of Kaplan-Bie et al..
Regarding claim 15: the growth pattern having vertical and horizontal aspects is the same as “wherein the growth topology of aerial mycelium comprises a vertical growth topology and a horizontal growth topology”.
Ross et al. does not teach “wherein maintaining the incubation chamber comprises maintaining the humidity by introducing aqueous mist into the incubation chamber at a rate of about 0.01 mg/cm2/hr to about 1 mg/cm2/hr to affect the vertical growth topology of aerial mycelium”
Kaplan-Bie et al. teaches that a localized high humidity environment is needed to allow for continued expansion and prevent collapse of hyphae (fourth par. in page 16). Thus, the disclosed closed chamber not only comprises an air flow system that provides vertical or horizontal airflow but also an atomizer misting system that controls deposition of mist onto growing fungi (last par. in page 16; first par. in page 17). Kaplan-Bie et al. teaches producing a total volume moisture of 0.8 µS/cm per minute and a target deviation in moisture across the panel surface of 0.00014 g/min (second par. in page 17). Accordingly, one with ordinary skill in the art would have grown Ross et al.’s mycelium using Kaplan-Bie et al.’s closed chamber comprising an air flow system and an atomizer system with reasonable expectation that providing a vertical air flow and mist would affect the vertical growth topology of said mycelium. Although Kaplan-Bie et al. does not disclose the rate of mist being deposited in terms of mg/cm2/hr, it can be predicted that a person with ordinary skill in the art would have found the recited misting rate through routine experimentation and optimization.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public pol4icy (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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of co-pending Application No. 18/826794.
The co-pending application is directed to a method of growing an aerial mycelium material comprising: (i) pasteurizing a substrate in an at least one tool located at a select physical location to form a pasteurized substrate; (ii) inoculating the pasteurized substrate with a fungal inoculum in a targeted fashion in the at least one tool at the select physical location to form a pasteurized and inoculated substrate, such that the targeted fashion of inoculating results in mycelium growing from the pasteurized and inoculated substrate in a regular geometric distribution upon a surface of the pasteurized and inoculated substrate; (iii) incubating the pasteurized and inoculated substrate to promote mycelial growth and form the aerial mycelium; and (iv) harvesting the aerial mycelium from the substrate.
The fungal inoculum is selected from a group that includes a solid fungal inoculum. Moreover, the substrate can be provided in at least one growth rack, bed, or tool within an incubation chamber.
Although the claims at issue are not identical, they are not patentably distinct from each other because the disclosed method’s inoculating step can comprise a first inoculation step and a second inoculation step in which the latter is accomplished by injecting or punching a fungal inoculum to a vertical level of the substrate that is different from the vertical level of the fungal inoculum from the first inoculation step. In an embodiment, the inoculating step comprises first and second depositing steps, wherein the first and second depositing steps are accomplished by two different depositing methods, wherein the substrate comprises two layers of substrate, whereby the fungal inoculum is deposited in a distinct pattern or geometric configuration within or upon the two layers of substrate, or wherein an at least one of the two different depositing methods comprises placing the fungal inoculum below the upper surface of the two layers of substrate, or wherein the two different depositing methods comprise depositing the fungal inoculum in two different patterns within or upon the two layers of substrate. These teachings suggest that a second fungus can be used to inoculate a second layer of substrate.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651