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 .
DETAILED ACTION
This application is a US national phase of PCT/KR2022/018007, filed November 15, 2022, with foreign priority application KR10-2021-0157491, filed November 16, 2021.
Applicant’s Preliminary amendment filed May 13, 2024 is acknowledged.
Claims 1-17 are pending and under examination.
Information Disclosure Statement
The information disclosure statement filed May 13, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because no separate listing of references on an IDS has been filed with the prior art filed May 13, 2024. 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 Objections
Claims 10 and 16 are objected to because of the following informalities:
Claim 10, line 2, delete “producing mycelium by” to remove redundant claim language.
Claim 16, line 1, “the inoculum
Claim 16, line 3, “102 spores/ml or more” appears to be a typo when referring to the specification, and needs to be changed to “102 spore/ml or more”.
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):
(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 1-17 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claims contain 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.
It is apparent that Aspergillus oryzae CJI1100 strain with deposit number KCCM13053P is required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the Aspergillus oryzae CJI1100 with deposit number KCCM13053P. The compositions and process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public. Therefore, a deposit at a recognized depository may be made to obviate this rejection.
37 CFR 1.808 requires that the deposit of biological material be made under two conditions:
(A) access to the deposit will be available during pendency of the patent application making reference to the deposit to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C. 122, and
(B) with one exception, that all restrictions imposed by the depositor on the availability to the public of the deposited biological material be irrevocably removed upon the granting of the patent.
A certified deposit under the Budapest Treaty for Aspergillus oryzae CJI1100 with deposit number KCCM13053P, filed May 13, 2024 is acknowledged, and satisfies condition (A) of 37 CFR 1.808. However, condition (B) of 37 CFR 1.808 is not satisfied. Applicant is required to state condition (B) in the application to obviate this 112(a) rejection.
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 1-17 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.
Claims 1-5, 10, and 15-16 recite the parenthetical phrase “(Accession Number: KCCM13053P)” and renders the claim indefinite because it is unclear whether the limitation within the parentheses is part of the claimed invention. Furthermore, acronyms are required to be defined when using in the claim set. To obviate this rejection, Applicant may change claim 1 to “Aspergillus oryzae CJI1100 strain deposited under the Korean Culture Center of Microorganisms (KCCM) with accession number: KCCM13053P”. Claims 10 and 15 may refer to the strain as “Aspergillus oryzae CJI1100 strain with deposit number KCCM13053P”. Claims 2-5, 13 and 16 may refer to the strain as “Aspergillus oryzae CJI1100 strain”, as the accession number in the independent claims from which these depend are understood.
Claim 9 recites the limitation "the dried mycelium product" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the parenthetical phrase “(mycoprotein)” and renders the claim indefinite because it is unclear whether the limitation within the parentheses is part of the claimed invention
Dependent claims 6-8, 11-12, and 17 are likewise rejected as being dependent on an indefinite claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2, 4, and 8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites the CJI1100 strain contains a DNA sequence encoding the 18S rRNA sequence of SEQ ID NO: 1, which the CJI1100 strain in independent claim 1 already inherently possesses, thus does not further limit the claim.
Claim 4 recites the CJI1100 strain does not produce aflatoxin, which the CJI1100 strain in independent claim 1 already inherently does not produce aflatoxin, thus does not further limit the claim. The same reasoning is applied to claim 8 reciting the mycelium does not contain aflatoxin, which the mycelium produced by the CJI1100 strain recited in claim 5 from which it depends, inherently does not contain aflatoxin, thus does not further limit the claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-9 and 13-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
The Supreme Court has required analysis based on a 3-part test for subject
matter eligibility.
- Step 1: Is the claim to a process, machine, manufacture, or composition of
matter?
- Step 2A (The Judicial Exceptions): Prong 1: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
-Step 2A (The Judicial Exceptions): Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
- Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
Claims 1-9 and 13-17 recite an Aspergillus oryzae CJI1100 strain with deposit number KCCM13053P and compositions comprising the mycelium produced by the strain, and an inoculum of the strain, which is a statutory category of invention (Step 1: Yes).
Claims 1-9 and 13-17 are drawn to the A. oryzae CJI1100 strain, the mycelium produced by the strain, and a food product comprising the mycelium, and an inoculum comprising the strain. As evidenced by the Specification, the A. oryzae CJI1100 strain was isolated from fermented soybean lump and naturally does not produce aflatoxin and naturally produces mycelium (Examples 1-3). There is no evidence that this particular A. oryzae CJI1100 strain has any markedly different characteristic from other A. oryzae strains, nor that it has been genetically modified or altered that would enhance functionality in the ability for producing mycelium containing the recited amino acids in claims 1 and 3. Therefore, the A. oryzae CJI1100 strain is a naturally occurring organism that is a judicial exception in the form of being a product of nature (Step 2A, Prong 1: Yes).
Claims 13-14 recites a food product comprising the mycelium produced by the strain. Claims 15-17 recite an inoculum product comprising A. oryzae CJI1100. Generic food formulations comprising mycelium that contain methionine naturally produced from fungi, such as the claimed strain, are routine and well-understood in the industry. As evidenced by Serba et al. (Agronomy Research, 2020, vol. 18, no. 1, pgs. 290-300), A. oryzae RCAM 01133 strain naturally produces mycelium containing methionine, and discloses the well-understood feature of preparing food with the mycelial biomass (abstract, pg. 293). Furthermore, the claims recite a generic inoculum composition using conventional laboratory techniques, thus the claims do not recite additional elements that integrate the judicial exception into a practical application (Step 2A, Prong 2: No), nor do they recite additional elements that amount to significantly more than the judicial exception (Step 2B: No).
Therefore, claims 1-9 and 13-17 are not patent eligible subject matter.
Pertinent Prior Art
There is no prior art teaching the claimed Aspergillus oryzae CJI1100 strain with deposit number KCCM13053P containing a DNA sequence encoding 18S rRNA SEQ ID NO: 1.
Serba et al. (Agronomy Research, 2020, vol. 18, no. 1, pgs. 290-300) teaches two Aspergillus oryzae strains isolated as a result of selection from the F-931 industrial strain were used for the fermentation of soybean meal and micromycetes were cultivated by the solid-phase method in flasks on natural nutrient media containing soybean meal (pg. 53, col. 1, para 5-6). Serba et al. teaches that, after the cultivation of the A. oryzae strains on soy, the strains were added to fermented sauces and analyzed for total amounts of amino acids, which increased total amino acids in the fermented sauces (pg. 54, col. 2, para 3, Figure 4, Table 1). Although Serba et al. teaches the increased amino acids in the fermented soy sauces was caused by the synthesis of protein substances during solid-phase cultivation, in addition to released amino acids during fermentation by enzymes (pg. 54, col. 2, para 4), Serba does not explicitly teach either of these strains produce mycelium comprising methionine, only indicating the strains increase methionine content in the fermented soy sauce.
The closest prior art teaching of a closely related A. oryzae strain is: CN108865901-A, which teaches an A. oryzae strain SWS2 that has an 18S rRNA sequence that has 99.3% similarity to instant SEQ ID NO: 1. Though SWS2 strain was isolated from soil from a peanut farm, whereas CJI100 strain was isolated from fermented soybean lump (see specification p. 3, lines 20-23).
Conclusion
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657
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