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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/02/2025 has been entered.
Priority
This application claims benefit of priority to United Kingdom of Great Britain and Northern Ireland Application No. GB2102595.2 filed on 02/24/2021. Receipt is acknowledged of certified copies of paper required by 37 CFR 1.55.
Drawings
The Drawings filed on 02/23/2022 are accepted by the Examiner.
Restriction/Election
Newly submitted claim 39 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 39 is directed to a method of using the product of claim 25. The product of claim 25 and the method of claim 39 are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the product of claim 25, the mycelium-based material, can be used in a materially different process of using that product, such as a food product.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 39 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Amendments and Claim Status
In the reply filed on 10/02/2025, Applicant amended claims 25-27 and 37 and added new claims 38-43. Claims 1-24 were previously canceled. As discussed above, claim 39 is withdrawn by the Examiner as it is directed to a non-elected invention.
Claims 25-43 are currently pending.
Claim 39 is withdrawn.
Claims 25-38 and 40-43 are under examination.
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.
Claims 25-38 and 40-43 are 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.
The term “substantially” in claims 25-27 is a relative term which renders the claims indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is noted the instant Specification does not recite the term ‘substantially’ at all. While the instant Specification does state “the mycelium may be deactivated or otherwise rendered biologically inactive. In this way, the mycelium-based material comprises relatively little or no living mycelium” on Page 14 in the last paragraph, it does not recite ‘substantially’. Thus, it is unclear, even in light of the instant Specification, how much living mycelium can be present in the mycelium-based material for the material to have ‘substantially no living mycelium present.’ Therefore, claims 25-27, and all claims dependent upon these claims, are rendered indefinite.
Claim 38 recites the limitation "wherein the mycelium-based material comprises substantially no target substrate". There is insufficient antecedent basis for this limitation in the claim. Claim 25, the claim from which claim 38 depends, does not recite anything regarding a ‘target substrate.’ Thus, there is insufficient antecedent basis for this limitation in the claim.
The term “substantially” in claim 38 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much target substrate can be present for the mycelium-based material to comprise ‘substantially no target substrate’. For example, it is unclear if ‘substantially no target substrate’ means there is very little target substrate or if the mycelium-based material can comprise less target substrate than other components, meaning the other components make up the substantial portion of the mycelium-based material, and still be considered to comprise ‘substantially no target substrate.’ Thus, claim 38 is indefinite.
Claim 41 recites the limitation "wherein the mycelium-based material comprises little to no target substrate". There is insufficient antecedent basis for this limitation in the claim. Claim 26, the claim from which claim 41 depends, does not recite anything regarding a ‘target substrate.’ Thus, there is insufficient antecedent basis for this limitation in the claim.
The phrase “little to no target substrate” in claim 41 is a relative phrase which renders the claim indefinite. The phrase “little to no target substrate” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is noted the instant Specification states “ … the target substrate is significantly consumed by the mycelium such that little (e.g., less than 1 wt%, less than or equal to 0.1 wt%) to no target substrate is present …” on Page 12 in the last paragraph. However, the examples of less than 1 wt%, less than or equal to 0.1 wt%, are simply a few examples of what ‘little target substrate’ could be, not a definition of exactly how much ‘little target substrate’ is. It is unclear if there are other amounts of substrate that would fall within the realm of ‘little to no target substrate.’ Thus, claim 41 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.
Claims 25-38 and 40-43 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to a product of nature.
Claims 25-38 and 40-43 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite an organism comprising a mycelium-based material. This judicial exception is not integrated into a practical application because only this microorganism is claimed. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only a microorganism comprising a mycelium-based material is claimed.
With regard to Step 1, the microorganism as claimed in claims 25-38 and 40-43 is a composition of matter.
With regard to Step 2A, prong one, claims 25 and 26 encompass a microorganism of mycelium comprising a mycelium-based material. Thus, claims 25 and 26 are generally directed to a microorganism. It is indicated in the instant Specification that the methods described herein may be used to prepare materials that comprise mycelium. Additionally, the mycelium-based materials may include mycelium or one or more components from mycelium (e.g., hyphal filaments, mycelium cell walls). The Specification also notes mycelium forms the vegetative root portion of a fungus and may have branching, thread-like hyphae that can extend into a substrate (Specification, Page 3, Paragraph 2). Claim 27 recites a target substrate mixed with the plurality of hyphal filaments. The Specification notes the substrate comprises a biomaterial, such as hemp, flax, cotton, cork, sheep’s wool, wood, and/or coconut fibers, without limitation (Specification, Page 4, Paragraph 2). Thus, the broadest reasonable interpretation is the organism with other naturally occurring judicial exceptions, reading on the organism in its natural environment. It is noted mycelium is a naturally occurring microorganism. It is further noted that removing a natural organism from its natural environment and placing it in a non-natural environment does not alter the structure of the microorganism. Thus, it appears the mycelium is a natural form of a natural product that has been removed and included in the material as claimed. As such, the material of the claims, is deemed to be a natural product.
With regard to Step 2A, prong two, claims 25 and 26 do not recite any elements in addition to mycelium. Claim 27 recites a substrate in addition to the mycelium. The broadest reasonable interpretation of a substrate encompasses judicial exceptions such as the biomaterials listed above from the instant Specification. The microorganism and substrate do not interact in such a way to amount to significantly more than the judicial exception itself.
With regard to Step 2B, claims 25 and 26 do not recite any elements in addition to mycelium. Claim 27 recites a substrate in addition to the mycelium. The mentioned substrates, which include wood and coconut fibers, are elements abundantly found in nature. The combination of mycelium and a substrate is not deemed to render the composition non-natural. As such, the claims do not recite additional elements that alone or together amount to significantly more than the judicial exception itself.
Regarding dependent claims 28-38 and 40-43, it is noted that these claims only recite elements that further characterize the natural product, or further natural components that can be included with the composition. With regard to claims 28 and 32, the specific arrangement of hyphal filaments does not change the structure of the organism, thus this limitation does not render the composition non-natural. With regard to claims 29 and 31, the mycelium-based material further comprising a target substrate and a given amount of that substrate, which includes other elements abundantly found in nature like wood or coconut fibers, does not render the composition non-natural. With regard to claim 30, the amount of chitin within the hyphal filament is an inherent characteristic and further characterizes the natural product as the amount of chitin is specific to species and environmental conditions, such as what the mycelium is grown on, as evidenced by Manan et al. (Journal of Bioresources and Bioproducts, 01/07/2021). With regard to claim 33, the porosity of the mycelium does not render the composition non-natural as the porosity of mycelium is an inherent characteristic and further characterizes the natural product as the porosity of mycelium can differ by age of the mycelium as evidenced by Olivero et al. (Scientific Reports, 11/07/2023). With regard to claim 34, the thickness of the mycelium composition does not change the structure of the organism, thus this limitation does not render the composition non-natural. With regard to claim 35, the amount of water present in the composition does not change the structure of the organism, thus this limitation does not render the composition non-natural. With regard to claim 36, the absence of a coating does not change the structure of the organism, thus this limitation does not render the composition non-natural. With regard to claim 37, the Young’s modulus of the substrate, which includes other elements abundantly found in nature, is an inherent characteristic of the substrate and does not change the structure of the organism, thus this limitation does not render the composition non-natural. With regard to claims 38 and 41, the mycelium-based material comprising substantially no target substrate, leaving just the mycelium, does not render the composition non-natural. With regard to claim 40, the mycelium-based material further comprising hemp, cotton, wood or coconut fibers, all natural products, does not render the composition non-natural. With regard to claims 42-43, the amount of chitin within the hyphal filaments is an inherent characteristic of the mycelium, as discussed above, and does not render the composition non-natural.
35 USC § 101 – Response to Arguments
In the reply filed on 10/02/2025, Applicant made multiple arguments, all of which will be addressed below.
Applicant argued a mycelium-based material based on deactivated mycelium, including deactivated mycelial components such as hyphal filaments, is not a product of nature since in nature, all of the mycelium in a material would not be simultaneously deactivated – that requires human intervention (Page 6, Last Paragraph).
Applicant’s arguments have been fully considered but are not persuasive. The instant Specification states “the mycelium may be deactivated or otherwise rendered biologically inactive,” indicating deactivated and biologically inactive are one in the same. It is well known that microorganisms in nature die, reading on deactivated or biologically inactive. If the mycelium died, the hyphal filaments would all simultaneously be deactivated. Additionally, it is noted Amstislavski et al. disclose when fungal species that are used for the manufacture of mycelium-based materials originate from warm regions, these species typically become dormant or biologically inert when exposed to colder temperatures (Paragraph [0075]). Thus, it is clear that mycelium can be rendered deactivated, or biologically inert, in nature due to temperature shifts. Therefore, it would not necessarily require human intervention for mycelium to become deactivated as it occurs in nature.
Applicant further argued a mycelium-based material comprising crosslinked hyphal filaments is not a product of nature, since in nature, the hyphal filaments would not be crosslinked (Page 7, Paragraph 2).
Applicants arguments have been fully considered but are not persuasive. It is noted the instant Specification does not provide a definition of ‘crosslinked’ or ‘fused,’ just simply states “ … the hyphal filaments of the mycelium-based material may be fused and/or crosslinked … in some cases, the hyphal tips may become crosslinked amongst each other … in some cases, the hyphal tips may make contact with other hyphal tips of the mycelium and may fuse to one another” (Specification, Page 20, Paragraph 2). The instant Specification does not appear to delineate between ‘fused’ and ‘crosslinked’ in a meaningful manner as neither term is defined and both appear to be drawn to the hyphal filaments (tips) being connected or linked to one another. Thus, if the hyphal filaments are fused, they are also crosslinked, and vice versa. Therefore, fusion of hyphal filaments reads on the hyphal filaments being crosslinked. Moreover, it appears, absent evidence to the contrary that the hyphal filaments comprising mycelium are naturally crosslinked or fused, as evidenced by Islam et al. (Of Record). Islam et al. disclose mycelium grows out by apical tip expansion of hypha from a spore or an inoculum. After an isotrophic growth phase, hypha initiates random branching, forming fractal tree-like colonies. Colonies interconnect randomly through hyphal fusion (anastomosis) to form a random fiber network structure (Page 1, Paragraph 3). Accordingly, it appears the mycelium hypha, reading on hyphal filaments, naturally grow in a disordered network where the hypha interconnect randomly through hyphal fusion, reading on being crosslinked and/or fused.
Applicant additionally argued the Patent Office has not (a) selected an appropriate naturally occurring counterpart, (b) identified appropriate characteristics for analysis, or (c) evaluated characteristics to determine whether they are different (Page 7, Paragraph 3). Further, that mycelium-based materials comprising substantially no living mycelium are markedly different from their counterpart, in particular, when the material contains living mycelium (Page 7, Paragraphs 4 and 5).
Applicants arguments have been fully considered but are not persuasive. As disclosed above, the closest naturally-occurring counterpart to the claimed mycelium-based material is mycelium as it exists in nature. As just discussed, mycelium in nature can naturally be deactivated, or rendered biologically inert, and is naturally crosslinked. Thus, the closest naturally occurring counterpart is mycelium as it exists in nature and there are no markedly different characteristics in the claimed mycelium-based product as it is simply mycelium exactly as it is found in nature.
Claim Rejections - 35 USC § 103
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 25-34, 36-37, 40 and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Amstislavski et al. (US 20170218327 A1, 08/03/2017) (Of Record) in view of Synowiecki et al. (Food Chemistry, 1997), Akitsu et al. (JP 6756069 B1, 09/16/2020) (Of Record), and Islam et al. (Scientific Reports, 10/12/2017) (Of Record).
Regarding claims 25-27, 30 and 42-43, Amstislavski et al. disclose:
methods for producing a biodegradable insulation material comprising forming a structural scaffold; inoculating the structural scaffold with at least one temperature resilient fungus in the presence of a nutritive media under environmental conditions that allow for mycelium growth; and allowing mycelium of the temperature resilient fungus to achieve desired density, thermal conductivity, elastic moduli, Young’s modulus, compressive strength, and thickness (See entire document, More specifically, Paragraph [0019]).
Amstislavski et al. further disclose a biodegradable insulation material comprising a) a structural scaffold comprising a nutritive media for fungal mycelium; and b) at least one temperature resilient fungus (Claim 1 of Amstislavski et al.). Mycelium, the vegetative part of the fungus, is a hollow structure consisting of a mass of branching, hollow tubular, chitinous hyphae which provides a fast growing, safe and inert material as the matrix for a new generation of natural foams, or biofoams (Paragraph [0145]). As the mycelium grows, a network of branching hyphae, primarily composed of chitin, binds together the nutritive substrate consisting of biomass and creates a vast three-dimensional matrix (Paragraph [0145]).
Amstislavski et al. further disclose for applications where biomass expansion is not desirable, the fungal mycelium is rendered biologically inert by heating the blocks to 60 degrees centigrade or higher in a dryer during the manufacturing process (Paragraph [0126]). It is noted the instant Specification states “the mycelium may be deactivated or otherwise rendered biologically inactive” on Page 14 in the last paragraph. Thus, the disclosure of Amstislavski et al. of rendering the fungal mycelium biologically inert reads on the mycelium-based material being deactivated.
Amstislavski et al. do not disclose wherein a wt% of chitin within the hyphal filaments is greater than or equal to 1% of 5% wt or less than or equal to 50 wt%.
However, Synowiecki et al. disclose the mycelia of Mucor rouxii can be used as a source of chitin for many purposes (Abstract). The contents of chitin and chitosan in the mycelia from 2-day old cultures were 8.9 and 7.3% on a dry basis, respectively (Abstract).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the mycelium of Mucor rouxii as the mycelium in the method of Amstislavski et al. to create a biodegradable insulation material comprising mycelium as the method does not require a specific species of mycelium and Mucor roxii was a known and effective mycelium species useful for many purposes that contains at least 8.9% chitin as taught by Synowiecki et al. motivated by the desire to create an effective insulation material with at least 8.9% chitin. The disclosure of 8.9% chitin reads on greater than or equal to 1% or 5% wt and less than or equal to 50 wt%. It is noted mycelium is comprised of the hyphae, or hyphal filaments, therefore, the mycelium comprising 8.9% chitin by dry weight reads on the hyphal filaments comprising 8.9% chitin by dry weight.
Regarding the hyphal filaments being crosslinked. Amstislavski et al. do not explicitly state the hyphal filaments are crosslinked. However, Islam et al. disclose mycelium grows out by apical tip expansion of hypha from a spore or an inoculum. After an isotrophic growth phase, hypha initiates random branching, forming fractal tree-like colonies. Colonies interconnect randomly through hyphal fusion (anastomosis) to form a random fiber network structure (Page 1, Paragraph 3). Accordingly, it appears the mycelium hypha, reading on hyphal filaments, naturally grow in a disordered network where the hypha interconnect randomly through hyphal fusion, reading on being crosslinked. See the response to arguments below regarding ‘crosslinked’ and ‘fused.’ Thus, it would be expected the mycelium of Amstislavski et al. would necessarily have these same properties of the hypha being fused, or crosslinked.
Regarding thermal conductivity, Amstislavski et al. disclose the dried samples had a thermal conductivity ranging from 0.05 to 0.07 W/m·K (Paragraph [0173]), reading on less than 0.1 W/m·K. The dried samples have a lower thermal conductivity than the live samples due to the fact that the varying amount of moisture existing in the substrates and mycelium of live samples is replaced with low-thermal-conductivity air during the drying process (Paragraph [0173]). Moreover, lower thermal conductivity is desirable for thermal insulation materials (Paragraph [0175]).
Amstislavski et al. do not disclose wherein the thermal conductivity is less than or equal to 0.03 W/m·K.
However, as discussed above, Amstislavski et al. do disclose a thermal conductivity range of 0.05 to 0.07 W/m·K and that lower thermal conductivity is desirable for thermal insulation materials. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP 2144.05(II)(A). See also, In re Aller, 220 F .2d 454, 456,105 USPQ 233, 235 (CCPA 1955). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine all operable and optimal thermal conductivities of the mycelium because thermal conductivity is an art-recognized result-effective variable wherein low thermal conductivity is desirable for thermal insulation materials as disclosed by the prior art above. Therefore, the thermal conductivity would have been routinely and predictably optimized to create a mycelium based material that posses the desired properties, including thermal conductivity. Although the prior art does not teach the specific thermal conductivity claimed, it would have been conventional and within the skill level of an ordinary artisan to modify the thermal conductivity motivated by the desire to create an effective mycelium-based thermal insulation material.
Regarding the heat of combustion, Amstislavski et al. disclose microcombustion calorimetry tests showed that cotton fabric coated with chitin, the structural component of a biodegradable insulation material, had a significantly lower peak heat-release and total heat-release values compared with that of uncoated cotton fabric. Thus, the biodegradable insulation material can have similar fire-retardant properties (Paragraph [0137]). It is noted microcombustion calorimetry tests measure the heat released during the combustion of small samples of a material. It is further noted the heat of combustion is the amount of heat released when a substance completely burns, or combusts. Thus, the microcombustion calorimetry test is directly related to the heat of combustion.
Amstislavski et al. do not disclose the heat of combustion of the mycelium-based material is less than or equal to 30 or 17 MJ/kg.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have created a mycelium-based product with a low heat of combustion, such as less than or equal to 30 or 17 MJ/kg, through routine experimentation as it is known that having a low heat of combustion is an important property for fire safety. One would be motivated to create a mycelium-based material with a low heat of combustion to create a fire retardant insulation material as taught by Amstislavski et al.
Amstislavski et al. disclose higher precision in controlling thermal, mechanical, and fire retardant properties of the resultant biodegradable insulation material during the manufacturing process is critical because it affords the manufacturer to program the shape and material properties needed for a specific application by specifying the scaffold’s thickness, porosity, nutrient content, shape and other variables that effect biodegradable insulation material’s performance for a given application (Paragraph [0129]).
Amstislavski et al. do not disclose a porosity greater than or equal to 1%.
However, Akitsu et al. disclose a porosity of 35-70% (Page 3, Paragraph 6). Akitsu et al. further disclose when the porosity is less than 35%, the gap structure is likely to be blocked before the mycelium grows sufficiently and if the porosity is more than 70% the mycelium density is unlikely to increase (Page 3, Paragraph 6).
Generally, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I). As such, it would have been prima facie obvious to one of ordinary skill in the art before effective filing date of the claimed invention to have used the method of Amstislavski et al. to create a mycelium based composition with a porosity of 35 – 70% as that range allows the mycelium to grow sufficiently and the density to increase as taught by Akitsu et al.
Claim 27, and 31, additionally recites a target substrate mixed with the plurality of hyphal filaments, wherein the wt% of target substrate in the mycelium-based material is greater than or equal to 1 wt%. Amstislavski et al. disclose the biodegradable insulation material of claim 1, wherein the scaffold, reading on a target substrate, is colonized by mycelium of the temperature resilient fungus (Claim 12).
Amstislavski et al. does not disclose wherein the substrate is greater than or equal to 1 wt%.
However, Akitsu et al. disclose a base material, like sawdust, rice straw and bark, reading on a substrate, wherein the ratio of plant matter is 10 to 40% volume with respect to the total volume of the mixture of all the components of the medium containing water (Page 2, Paragraph 13). Generally, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I). As such, it would have been prima facie obvious to one of ordinary skill in the art before effective filing date of the claimed invention to use the method of Amstislavski et al. to create a mycelium based composition wherein the substrate is 10-40% volume, falling within the claimed range of greater than 1%, as that range was a known and effective range as taught by Akitsu et al., with a reasonable expectation of success. The substrate being 10-40% also reads on the substrate being greater than or equal to 5 wt%, the limitation of instant claim 31.
Regarding claims 28 and 32, Amstislavski et al. do not disclose wherein the plurality of hyphal filaments is arranged to form a disordered network or wherein the hyphal filaments are at least partially crosslinked or fused.
However, Islam et al. disclose mycelium grows out by apical tip expansion of hypha from a spore or an inoculum. After an isotropic growth phase, hypha initiates random branching, forming fractal tree-like colonies. Colonies interconnect randomly through hyphal fusion (anastomosis) to form a random fiber network structure (Page 1, Paragraph 3).
Accordingly, it appears the mycelium hypha naturally grow in a disordered network where the hypha interconnect randomly through hyphal fusion. As such, it would be expected the mycelium of Amstislavski et al. would necessarily have these same properties.
Regarding claim 29, Amstislavski et al. disclose the biodegradable insulation material of claim 1, wherein the scaffold, reading on a target substrate, is colonized by mycelium of the temperature resilient fungus (Claim 12 of Amstislavski et al.).
Regarding claim 33, Amstislavski et al. do not disclose a porosity greater than or equal to 1% and/or less than or equal to 70%.
However, However, Akitsu et al. disclose a porosity of 35-70% (Page 3, Paragraph 6). Akitsu et al. further disclose when the porosity is less than 35%, the gap structure is likely to be blocked before the mycelium grows sufficiently and if the porosity is more than 70% the mycelium density is unlikely to increase (Page 3, Paragraph 6).
Generally, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05(I). As such, it would have been prima facie obvious for one of ordinary skill in the art before effective filing date of the claimed invention to use the method of Amstislavski et al. to create a mycelium based composition with a porosity of 35 – 70%, which falls with the claimed range, as that range allows the mycelium to grow sufficiently and the density to increase as taught by Akitsu et al.
Regarding claim 34, Amstislavski et al. disclose the thickness can vary based on how much room is present in the infrastructure to be insulated. In some instances, the thickness can be 2.5 cm to 10 cm (Paragraph [0094]). The disclosed range reads on greater than 1 mm and/or less than 150 mm as 2.5 cm converts to 25 mm and 10 cm converts to 100 mm.
Regarding claim 36, Amstislavski et al. disclose the hydrophobic properties of mycelium due to self-skinning. Self-skinning occurs when a solid face, film-like barrier is produced by the mycelium when it encounters a non-nutritive barrier. This self-skinning property produces a self-healing, hydrophobic skin that prevents water-logging (Paragraph [0124]).
Amstislavski et al. do not explicitly state the mycelium-based material is absent any coating.
However, as Amstislavski et al. disclose the mycelium itself produces a protective outer skin, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the mycelium based material would be absent any coating due to there being no need for a coating considering the mycelium creates its own outer skin that functions as a coating would and protects it from the elements, such as water-logging.
Regarding claim 37, Amstislavski et al. disclose a method for producing a mycelium based material that includes pressing the scaffold colonized by mycelium of the temperature resilient fungus to achieve desired density, thermal conductivity, elastic moduli, Young’s modulus, compressive strength, and thickness (Paragraph [0019]). Amstislavski et al. further disclose biofoam samples with an average Young’s modulus of 21.18 ±16.21 (MPa) (Paragraph 0138]).
Amstislavski et al. do not explicitly disclose the substrate having a Young’s modulus greater than or equal to 1 GPa and/or less than or equal to 130 GPa. 1 MPa is equivalent is 0.001 GPa. As such, the disclosure of a mycelium based material with an average Young’s modulus of 21.18 ±16.21 (MPa) reads on less than 130 GPa as the substrate must have a Young’s modulus within the claimed range if the material as whole, which includes the substrate, falls within the claimed range.
Regarding claim 40, Amstislavski et al. disclose various substrate materials including wood pulp, millet grain, wheat bran, natural fiber and calcium sulfate (Paragraph [0180]). Wood pulp reads on wood.
Claims 25-38 and 40-43 are rejected under 35 U.S.C. 103 as being unpatentable over Amstislavski et al. (US 20170218327 A1, 08/03/2017) (Of Record) in view of Synowiecki et al. (Food Chemistry, 1997), Akitsu et al. (JP 6756069 B1, 09/16/2020) (Of Record), and Islam et al. (Scientific Reports, 10/12/2017) (Of Record) and further in view of Manan et al. (Journal of Bioresources and Bioproducts, 01/07/2021).
Regarding claim 35, the prior art discussed above does not disclose the amount of water present in the mycelium-based material is less than or equal to 20 wt%.
However, Manan et al. disclose synthesis and applications of fungal mycelium-based advanced functional materials (See entire document, More specifically, Title). Manan et al. further disclose the water holding capacity of mycelium is largely dependent on the substrate, for example, the water content of a T. multicolor-based material ranged between 5.8% - 7.2% and 7.6% - 9.6% when grown on cotton and rapeseed straw, respectively (Page 4, Paragraph 3).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the water content would vary depending on the substate used with the mycelium. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize T. multicolor and either cotton or rapeseed straw as the mycelium and substrate in the method of Amstislavski et al. to create a mycelium-based material because the method does not require a specific species of mycelium or substrate and would produce a mycelium-based material with a water content between 5.8 – 9.6% as taught by Manan et al. The water content being between 5.8 – 9.6% reads on less than 20 wt%.
Regarding claims 38 and 41, see 112b above. The prior art discussed above does not disclose the mycelium-based material comprises substantially no target substrate or little to no target substrate.
However, Manan et al. disclose mycelium-based materials are produced by growing the vegetative part of the mushroom-forming fungi on different organic substrates. Pure mycelium-based materials are obtained through complete degradation of the substrate (Page 2, Paragraph 1).
Thus, it would have been obvious to one of ordinary skill in the art to utilize a substrate that could be completely degraded by the mycelium in the method of Amstislavski et al. motivated by the desire to create a mycelium-based material that was pure mycelium as taught by Manan et al.
The Supreme court acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable varition..103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions…
…the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) emphasis added.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
The Examiner is therefore of the opinion that from the combined teachings of the references cited above, that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art especially in the absence of unexpected results.
35 USC § 103 – Response to Arguments
Applicant argued the claims have been amended to specify that the hyphal filaments are crosslinked, and previously, claim 32 was rejected solely based on an allegation that the cited art teaches fused hyphal filaments. Applicant further stated the crosslinking of hyphal filaments was not addressed (Page 8, Paragraph 2).
Applicants arguments have been fully considered and the Examiner agrees that ‘crosslinking’ specifically was not addressed. However, ‘crosslinking’ was not addressed because claim 32 previously recited “wherein the hyphal filaments are at least partially crosslinked or fused.” Thus, as the prior art specifically disclosed “hyphal fusion,” the Examiner based the rejection on the hyphal filaments being fused. It is noted the instant Specification does not provide a definition of ‘crosslinked’ or ‘fused,’ just simply states “ … the hyphal filaments of the mycelium-based material may be fused and/or crosslinked … in some cases, the hyphal tips may become crosslinked amongst each other … in some cases, the hyphal tips may make contact with other hyphal tips of the mycelium and may fuse to one another” (Specification, Page 20, Paragraph 2). The instant Specification does not appear to delineate between ‘fused’ and ‘crosslinked’ in a meaningful manner as neither term is defined and both appear to be drawn to the hyphal filaments (tips) being connected or linked to one another. Thus, if the hyphal filaments are fused, they are also crosslinked, and vice versa. Therefore, fusion of hyphal filaments reads on the hyphal filaments being crosslinked.
Applicant further argued the Patent Office misunderstood Amstislavski et al. and misapplied the law. Applicant stated Amstislavski et al. was misunderstood because a person of ordinary skill in the art would know that the hyphae are not primarily composed of chitin and the cited language of Amstislavski et al. must instead refer to the network or some other portion of the material taught by Amstislavski et al. Applicant also stated references are interpreted as one of ordinary skill in the art would interpret them, not using the broadest reasonable interpretation (Page 9, Paragraph 1).
Applicant’s arguments have been fully considered but are not persuasive. The Examiner agrees references are interpreted as one of ordinary skill in the art would, which is how Amstislavski et al. was interpreted. One of ordinary skill in the art, reading Amstislavski et al., who specifically teach “as the mycelium grow, a network of branching hyphae, primarily composed of chitin …” in Paragraph [0145], would interpret that to mean exactly what is stated, the branching hyphae, reading on hyphal filaments, are primarily composed of chitin. Thus, the interpretation of Amstislavski et al. is not the broadest reasonable interpretation, it is simply what is specifically stated by Amstislavski et al.
Applicant additionally argued the quotations from Elsoud are not supported from the actual teachings of Elsoud.
The Examiner agrees some portions of Elsoud were misinterpreted. Thus, Elsoud is not part of the rejection set forth above.
Conclusion
Claims 25-38 and 40-43 are rejected.
No claims are allowed.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653