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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the instant drawings are corrupted .The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
The drawings provided in the instant application:
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318
630
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378
640
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Drawings in WO 2023/191102:
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390
656
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394
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Information Disclosure Statement
The information disclosure statement filed 09/27/2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because none of the copies of non-patent literature listed in the IDS have been provided. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for koji (Aspergillus oryzae), does not reasonably provide enablement for any “fungi”. A fungus is any member of the group of eukaryotic organisms that includes yeasts, molds, and mushrooms. The fungus kingdom has been estimated at 2.2 million to 3.8 million species. Of these, about 148,000 have been described. The instant specification only provides guidance for koji (Aspergillus oryzae).The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Case law holds that applicant's specification must be "commensurately enabling [regarding the scope of the claims]" Ex parte Kung, 17 USPQ2d 1545, 1547 (Bd. Pat. App. Inter. 1989) otherwise undue experimentation would be involved in determining how to practice and use applicant's invention. Although the statute itself does not use the phrase "undue experimentation", it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation as stated in Ex parte Forman, 230 USPQ 546, 547 (Bd. Pat. App. Inter. 1986) and in In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Specifically, in In re Wands the Court set forth a non-exhaustive list of factors to be considered in determining whether undue experimentation would be involved in making and/or using the claimed invention. These factors 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. Applying these factors to claim 9:
(A) The breadth of the claims
The claim is broad in the scope in the sense that it encompasses any fungus species.
(B) The nature of the invention
The invention relates to a fermentation of cashew with koji (Aspergillus oryzae)
(C) - (E) State of the prior art/The level of ordinary skill/The level of predictability
Fermentation of edible substrates with koji is an old art. However, the art is not without uncertainty. Production of raw nut fermented products lies somewhere between a predictable art and an unpredictable art. However, when the skilled artisan attempts to calculate all the compositions containing fungi species, predictability is lost due to the complexity of art.
F. The amount of direction provided by the inventor
The entirety of the direction offered by the specification relates to koji (Aspergillus oryzae). There is no direction provided for fungi other than koji (Aspergillus oryzae).
G. The existence of working examples
The specification provides one working example directed to culturing and using koji (Aspergillus oryzae).
H. The quantity of experimentation
A large amount of experimentation, on the order of a number of man-years would be necessary to practice the invention within the full scope of the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the following limitations:
A method if incubating cashew nuts with fungi comprising
using a pre-culture of fungi grown in plant-based broth or;
using of commercially available spores that can be spread directly on the cashew nuts.
The instant claims recites the condition statement “if”, “if incubating cashew nuts with fungi”, then using the fungi. It is not clear what are the alternative method steps when the cashew nuts are not incubated with fungi. It is also not clear how exactly the fungi are used.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Azuki250 (Raw Nut Cheese).
Uchida et al (Development of koji by culturing Aspergillus oryzae on nori (Pyropia yezoensis) is applied as evidence as discussed below.
In regard to claim 1, Azuki250 discloses incubating cashew nuts with koji, nutritional yeast, miso, etc. fungi.
As evidenced by Uchida et al, “Koji is a traditional fermentation culture medium, based on Aspergillus oryzae, which is commonly used in the manufacture process of Japanese fermented products such as soy sauce, miso, and sake, and promote enzymatic degradation. Koji is usually prepared by culturing a mold on cereals such as wheat flour, soybean, or rice...” (Abstract).
Hence, Azuki250 meets the limitation of “incubating cashew nuts with fungi” where fungi (i.e. koji, Aspergillus oryzae) is cultured in pant-based substrate (cereals such as wheat flour, soybean, or rice).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VERA STULII whose telephone number is (571)272-3221. The examiner can normally be reached Monday-Friday 5:30AM-3:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki Dees can be reached at 571-270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VERA STULII/Primary Examiner, Art Unit 1791
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