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 .
Priority
The present application is a § 371 National Stage Entry of PCT/US2021/064524 (filed on 12/21/2021) and claims benefit of U.S. provisional application 63/130,491 (filed on 12/24/2020).
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 06/23/2023 and 09/20/2023 are in compliance with the provisions of 37 C.F.R. 1.97. All references cited in these IDSs have been fully considered.
Claim Status
Claims 1-7, 9, 12-16, 18, 22, 25-27, 29, and 31 are currently pending and have been examined on their merits.
Drawings
The drawings are objected to for the following minor informalities.
Figs. 7-19 and 24-25 contain text which is too small and which is in insufficient quality to be readable when reproduced;
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to for the following minor informalities.
Page 81 presents “Example 20”. This example should be renumbered to “Example 18” because it is preceded by Example 17.
The use of the following terms, which are trade names or a marks used in commerce, have been noted in this application. These term should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. These terms are Bakelite, Kevlar, Mylar, Neoprene, Nomex, Orlon, Rilsan, Technora, Teflon, Twaron, Ultem, Vectran, Viton, Zylon, Pyrex, and Biosyn.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
Claim 7 is objected to because it recites a Markush grouping (“the group consisting of”) which is terminated by the conjunction “or”. Because the group is a closed group, the appropriate conjunction is “and”.
Claim 18 is objected to because conventionally the names of taxonomic orders and families are not italicized.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112:
(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.
(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.
Claims 1-7, 9, 12-16, 18, 22, 25-27, 29, and 31 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for production of durable sheet material with MK7, does not reasonably provide enablement for production of the same with every “filamentous fungus” covered by the breadth of the claims.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors considered when determining if there is sufficient evidence to support that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue” include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). MPEP § 2164.04
further states that although the analysis and conclusion of a lack of enablement are based on these factors and the evidence as a whole, it is not necessary to discuss each factor in the enablement rejection.
With respect to the nature of the invention, applicant’s claims are directed to the preparation of “durable sheet material comprising fungal biomass”. The methods comprise the steps of culturing a filamentous fungus, inactivating the biomass, infiltrating the inactivated biomass with a solution comprising a solvent and a polymer, crosslinker, and combinations and mixtures thereof, and curing the biomass.
With respect to the breadth of the claims, applicant’s claims broadly encompass the use of any “filamentous fungus” in the method of preparation. As demonstrated by claim 18, this scope is so broad as to encompass any filamentous fungus including entire orders of fungi (e.g., Ustilaginales, Russulales, Agaricales, Pezizales, and Hypocreales). Similarly, the claims also broadly include the use of any solvent, polymer, and crosslinker.
With respect to the state of the prior art, the closest prior art, Kozubal et al. (WO 2017/151684 A1; hereinafter Kozubal; cited in IDS filed on 09/20/2023) teaches a novel method of growing fungi, which produces high density filamentous fungi biomats that can be harvested with minimal processing (abstract). Kozubal’s methods comprise inoculating one or more of the fungal species or strains and/or its progeny into artificial media and growing said isolated fungal strain in said artificial media to produce a filamentous fungi biomat (i.e., culturing a fungal species in or on a fermentation medium)([86]). Kozubal teaches the generation of filamentous fungi biomats. Additionally, Kozubal teaches that the invention uses a large number of isolated filamentous fungal species ([84]). Following inoculation, Kozubal teaches that filamentous fungi biomats can be harvested by a number of different methodologies including inactivation of viability ([101]). It is noted that although Kozubal also prophetically teaches the use of any filamentous fungus, it has reduced to practice only the culture of MK7. Kozubal teaches that the growth characteristics of MK7 vary dramatically as a function of growth medium and fermentation conditions ([159]).
Jones et al. (Nature Sustainability, 2020, Vol. 4, pages 9-16; hereinafter Jones) reviews fungi-derived leather substitutes and teaches that fungi-derived leather-like materials most commonly constitute either a pressed fiber pulp derived from masses of hyphal filaments grown in liquid nutrients or a physically and chemically treated mycelium mat grown on a bed of solid particles (liquid and solid-state fermentation). Jones does not discuss the use of air-medium colloid (AMC). Jones does, however, acknowledge that “[i]nherent biological variation in fungal growth makes uniform thickness and surface texture difficult to achieve in mycelium-derived leather-like materials” (p. 4, right col., par. 3).
Krull et al. (Journal of Biotechnology, 2013, Vol. 163, pages 112-123; hereinafter Krull) reviews biotechnology applications of filamentous fungi and teaches that fungal forms can vary from dense spherical pellets to viscous mycelia (abstract). Krull specifically teaches that complex fungal morphology is “one of the most sensitive process parameters” and “depending on the desired product, the optimal morphology for a given bioprocess varies and cannot be generalized” (p. 112, left col., par. 1). Krull expands on this and states that because optimal productivity corelates with a specific morphological form, the advantages and disadvantages of mycelial or pellet cultivation should be carefully balanced for each biological system (p. 112, left col., par. 1 through right col., par. 1).
None of the prior art teaches or suggests the generation of durable sheet materials by culturing a filamentous fungus in or on a fermentation medium, wherein the fermentation medium is an air-medium colloid (AMC).
With respect to the level of one of ordinary skill, a person having ordinary skill in the art is a person having an advanced understanding of the biological sciences and/or textile manufacturing.
With respect to the amount of direction provided by the inventor and the existence of working examples, applicant has provided a litany of tests and working examples involving the production of durable sheets with MK7. These examples provide guidance as to the effects of various components (e.g., plasticizers, CN ratios, polymers, etc.) on the mechanical strength of fungal textiles generated from the filamentous fungus MK7. Applicant has only reduced to practice the production of durable sheet materials with MK7.
With respect to the level of predictability and the quantity of experimentation needed, applicant is not required to actually reduce to practice the preparation of durable sheet materials with every filamentous fungus, the method must be performable without undue experimentation. As discussed above, there is known to be variability even within a single strain of filamentous fungus (such as MK7) due to changes in growth media, fermentation conditions, or simply due to biological differences. And, as discussed by Krull, fungal morphology is complex and cannot be generalized. Thus, although a person having ordinary skill in the art would be guided by applicant’s disclosure as to how to prepare a “durable sheet material” when the filamentous fungus is MK7, there would undue experimentation required in order to enable a method of preparing a “durable sheet material” with any other type of filamentous fungus. Applicant’s method requires that the sheet material is “durable” and the specification demonstrates that varying reaction conditions can cause immense changes in sheet durability (see, for example, Tables 1-5 of the specification). Thus, when performing the method with any other type of filamentous fungus, a person having ordinary skill in the art would need to produce a litany of sheet materials under different reaction conditions and test each of their mechanical properties in order to determine which, if any, are “durable sheet materials”. This experimentation is undue.
Conclusion
Upon consideration of applicant’s disclosure and the Wands factors as a whole, the invention is enabled for preparing a durable sheet material comprising fungal biomass when the filamentous fungus is MK7, but is not enabled, without undue experimentation, when the filamentous fungus is any filamentous fungus.
Claims 1-7, 9, 12-16, 18, 22, 25-27, 29, and 31 are rejected under 35 U.S.C. 112(a) 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 at the time the application was filed, had possession of the claimed invention.
As discussed above, applicant’s claims are directed to the preparation of “durable sheet material comprising fungal biomass”. The methods comprise the steps of culturing a filamentous fungus, inactivating the biomass, infiltrating the inactivated biomass with a solution comprising a solvent and a polymer, crosslinker, and combinations and mixtures thereof, and curing the biomass. Additionally, applicant’s claims broadly encompass the use of any “filamentous fungus” in the method of preparation. As demonstrated by claim 18, this scope is so broad as to encompass preparing durable sheet materials from entire orders of fungi (e.g., Ustilaginales, Russulales, Agaricales, Pezizales, and Hypocreales).
The test for whether applicant has sufficiently fulfilled the written description requirement is whether applicant has disclosed sufficiently detailed, relevant identifying characteristics such as complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics (MPEP § 2163(II)(A)(3)(a)).
Thus, the relevant question is whether a person having ordinary skill in the art would recognize that applicant at the time the application was filed, had possession of methods of manufacturing “durable sheet materials” from every filamentous fungus.
Krull et al. (Journal of Biotechnology, 2013, Vol. 163, pages 112-123) reviews biotechnology applications of filamentous fungi and teaches that fungal forms can vary from dense spherical pellets to viscous mycelia (abstract). Krull specifically teaches that complex fungal morphology is “one of the most sensitive process parameters” and “depending on the desired product, the optimal morphology for a given bioprocess varies and cannot be generalized” (p. 112, left col., par. 1). Krull expands on this and states that because optimal productivity corelates with a specific morphological form, the advantages and disadvantages of mycelial or pellet cultivation should be carefully balanced for each biological system (p. 112, left col., par. 1 through right col., par. 1).
Because it is known in the art that there exists vast variability in fungal forms and the “optimal morphology for a given bioprocess varies and cannot be generalized”, applicant cannot meet the written description requirement for possession of preparing durable sheet materials from every filamentous fungus by merely describing the generation of durable sheets from a single filamentous fungus (MK7).
Claim 18 is rejected under 35 U.S.C. 112(a), as failing to comply with the enablement requirement.
The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification lacks complete deposit information for the deposit of strain MK7, said strain being deposited with ATCC under accession number PTA-10698. Because it is not clear that the properties of these strains are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of this specific strain, a suitable deposit for patent purposes is required.
It is not clear whether this deposit was made under the provisions of the Budapest Treaty.
If the deposit has been made under the provisions of the Budapest Treaty, the deposit requirement may be fulfilled by filing an affidavit or declaration by applicants or assignees or a statement by an attorney of record who has authority and control over the conditions of the deposit over his or her signature and registration number averring that:
the deposit was made under the Budapest treaty and “all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent”.
This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring that:
“during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request”;
“all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application”;
“the deposits will be maintained in a public depository for a period of at least thirty years from the date of the deposit or for the enforceable life of the patent or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest”; and
“the deposits will be replaced if they should become non-viable or non-replicable”.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR § 1.801-1.809 for further information concerning deposit practice.
Claims 5, 7, 13-16, 22, 27, 29, and 31 are rejected under 35 U.S.C. 112(b) 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 5 recites the approximation “about” (“an average particle size of no more than about 125 microns”). In determining the range encompassed by the term "about," one must consider the context of the term as it is used in the specification and claims of the application (MPEP § 2173.05(b)(III)(A)). Applicant’s specification has been fully considered and there is only one mention of average particle size (“[t]he size-reduced inactivated fungal biomass may, but need not, have an average particle size of no more than about 125 microns”; p. 2, lines 8-9). Applicant has not provided a special definition for the term “about”. Accordingly, it is not clear what amounts are encompassed by the approximation “about 125 microns”. For example, does applicant consider 120 microns to be “about 125 microns”? The claim should be amended such that the metes and bounds of the claim are distinctly defined.
Claim 7 similarly recites the approximation “about”. In order to determine definiteness, the phrase “about X hours” has been interpreted in light of the specification. The specification does not provide any guidance as to what is meant by “about X hours”. Accordingly, it is not clear what amounts of time are encompassed by the approximation. For example, is 3 hours “at least about 4 hours” ? The claim should be amended such that the metes and bounds of the claim are distinctly defined.
Claim 13 is considered to be indefinite because it requires the solution to comprise “a polymer” (singular) but provides a list which includes “combinations thereof” (plural). Accordingly, it is unclear if the “polymer” including “combinations thereof” is a single type of polymer comprising multiple elements from the recited list or if the “polymer” is multiple types of polymer (e.g., a PVA/PEG polymer versus a PVA polymer and a PEG polymer).
In the interest of compact prosecution, the term has been examined for “at least one polymer” including combinations of polymers recited in the group of claim 13 (i.e., under the latter interpretation).
Claim 14 recites the approximation “about”. Similar to the above situations, neither the claims nor the specification make it clear what applicant means by “about X wt%”. For example, is 20 wt% considered to be “about 25 wt%”? Or is there some other clearly defined beginning and end to the range elicited by the term “about”?
Claim 15 is considered to be indefinite because it requires the solution to comprise “a crosslinker” (singular) which is selected from a group which encompasses “combinations thereof” (plural). Accordingly, it is unclear how multiple crosslinkers could be included (through “combinations thereof”) when the claim is limited to “a crosslinker”. In the interest of compact prosecution, the claim has been interpreted similar to the interpretation set forth above for claim 13. That is, the claim is interpreted to include “at least one crosslinker” when the plurality of crosslinkers are combinations of crosslinkers recited in this claim.
Claim 16 is considered to be indefinite because it requires the solution to comprise “a plasticizer” from a group which encompasses “combinations thereof”. For the same reasons discussed above, this phrasing renders the claim indefinite. The claim has been interpreted to allow for more than one “plasticizer” despite the phrase “a plasticizer”.
Claim 22 is considered to be indefinite because it similarly recites singular terms (“a solubilizer” and “a pH adjusting agent”) from lists which encompass “mixtures thereof” (plural). The claim should be amended such that the metes and bounds are clearly defined. This claim has been interpreted as if the solubilizer or pH adjusting agent can be more than one element from the recited lists.
Claim 27 is rejected because it recites many approximations (“about”) as discussed above, neither the specification nor the claims distinctly clarifies what ranges are encompassed by this approximation. For example, is 2 wt% considered to be “about 2.5 wt%”? Or is there some other definite range of weight percentages encompassed by the approximation?
Claim 29 is rejected because it limits the “thermal dopant” (introduced as “a thermal dopant” in claim 26) to be a ceramic material, a metallic material, a polymeric material, and combinations thereof (plural). Accordingly, it is not clear how the single thermal dopant can be combinations thereof. For the same reasons discussed above, this phrasing renders the claim indefinite. The claim has been interpreted to allow for more than one “thermal dopant”.
Claim 31 is rejected because it recites the approximation “about”. As discussed above, the approximation is not clearly defined by the claims and specification. Accordingly, the scope of the claim is unclear. Moreover, the claim limits the ratio of carbon to nitrogen but only provides one half of the ratio (between about 5 and about 20). Because it is a ratio, the claim should be amended to also supply the nitrogen portion of the ratio (i.e., 5:1 instead of “a carbon-to-nitrogen ratio” of 5).
Conclusion: As discussed above, the claims recite approximations throughout. Because it is not possible to ascertain the boundaries established by the approximation, the claims cannot be examined for the approximation “about”. In the interest of compact prosecution, the claims have been examined for the amounts distinctly recited in the claims. For example, “about 5” has been examined as if it reads “5”.
Citation of Closest Prior Art
The closest prior art, Kozubal et al. (WO 2017/151684 A1; cited in IDS filed 09/20/2023) teaches a novel method of growing fungi, which produces high density filamentous fungi biomats that can be harvested with minimal processing (abstract). Kozubal’s methods comprise inoculating one or more of the fungal species or strains and/or its progeny into artificial media and growing said isolated fungal strain in said artificial media to produce a filamentous fungi biomat (i.e., culturing a fungal species in or on a fermentation medium)([86]). With respect to the requirement that the fungal species is a filamentous fungus, as discussed above, Kozubal teaches the generation of filamentous fungi biomats. Additionally, Kozubal teaches that the invention uses a large number of isolated filamentous fungal species ([84]). Following inoculation, Kozubal teaches that filamentous fungi biomats can be harvested by a number of different methodologies including inactivation of viability ([101]).
Accordingly, Kozubal teaches a step of culturing a filamentous fungus in or on a fermentation medium to form a biomass of the filamentous fungus and a step of inactivating the biomass to form an inactivated biomass.
The instant claims differ from the prior art because neither Kozubal nor the prior art as a whole teach or render obvious fermentation in or on an air-medium colloid (AMC), especially in combination with infiltrating the inactivated fungal biomass with a solution and curing the biomass to remove the solvent from the biomass.
Conclusion
No claim is allowed.
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/GRANT C CURRENS/Examiner, Art Unit 1651