DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1 and 6-8, and the following species: microalgae for claim 6, biomass for claim 7, feed composition for claim 8, biomass for claims 9 and 14, glucose for claim 12, a combination of yeast extract and sodium nitrate (NaNO3) for claim 13 in the reply filed on 05/04/2026 is acknowledged.
Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/04/2026.
Claims 1 and 6-8 (claims set filed 05/04/2026) are examined on the merits herein.
Priority
This application is a 371 of PCT/KR2022/011958 filed 08/10/2022. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) based on application REPUBLIC OF KOREA 10-2021-0152560 filed 11/08/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/07/2024, 02/19/2025, 06/18/2025, 01/28/2026 and 04/16/2026 comply with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Interpretation
Claim 1 recites: “A Schizochytrium sp. microalgae deposited under Accession number KCTC14661BP”. Claim 1 is interpreted under broadest reasonable interpretation in light of specification. According to the specification claim 1 is limited to Schizochytrium sp. CD01-2147 strain with accession number KCTC14661BP (p. 5, 2nd paragraph).
Applicant is suggested to insert CD01-2147 strain number into claim 1.
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 and 6-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) 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.
Claim 1 is directed to a Schizochytrium sp. microalgae deposited under the Accession number KCTC14661BP. It is apparent that microorganism with the Accession number KCTC14661BP is required to practice the claimed invention. As such the biological material must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112, first paragraph, may be satisfied by a deposit of the strain.
The 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. The prior art of Fu (Fu et al. Bioresource Technol., 2016, 221, 405-411) teaches screening of strains of Schizochytrium sp. obtained by mutagenesis for enhanced production of docosahexaenoic acid (DHA) (Abstract). From initial 500 colonies 18 colonies with higher lipid content were identified and during the secondary screening 4 mutant strains were selected with enhanced cell mass, DHA and lipid content (p. 406, right column, 5th paragraph, p. 408, right column, 2nd paragraph). Thus, a person skilled in the art could not make or use the invention defined without access to the specific biological material.
It is noted that the Schizochytrium sp. CD01-2147 strain was deposited: “to Korea Research Institute of Bioscience and Biotechnology Korea Collection for Type Culture (KCTC) which is an international depository authority under the Budapest Treaty on August 23, 2021 and was given an accession number KCTC14661BP “ (specification, p. 5, 3rd paragraph). However, the depositary information is not present (was removed in the amended specification), the viability statement is absent and there is no indication as to public availability statement.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration Applicant, by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) The deposit will be maintained in a public depositary for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
Claims 6-8, dependent on claim 1, do not resolve the issue mentioned above and are rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Park (KR 101847551 B1 on record in IDS).
Regarding claim 1, Park teaches Schizochytrium sp. microalgae strain SHG104 which is a mutant strain capable of high production of carotenoid antioxidant pigment and a DHA-containing bio-oil (Abstract). Park mentions that SHG104 strain was derived from natural SH104 strain isolated from seawater samples from the southwestern coast of Korea (paragraphs 0018 and 0052). Park describes that the SHG104 strain was isolated by inducing mutations by gamma irradiation in the parental strain SH104 and strain SHG104 was deposited with accession number KCTC13089BP (paragraph 0032). Park discloses that mutant SHG104 strain produces high amounts of bio-oil containing unsaturated fatty acids including 40-45% of DHA of total weight of fatty acids (Table 2, claim 1). The specification describes claimed strain with accession number KCTC1466BP to be a mutant strain obtained by gamma irradiation of a parental natural strain isolated from seawater, leaves and sediments collected from Korean west coast (p. 18, last paragraph, p. 27, last paragraph, p. 29, 1st paragraph). The mutant strain was selected based on enhanced production ability of polyunsaturated fatty acid-containing oil (specification, p. 5, 3rd paragraph).
Park does not teach Schizochytrium sp. microalgae with accession number KCTC14661BP. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that Schizochytrium sp. microalgae SHG104 described by Park is an obvious variant of instant Schizochytrium sp. microalgae with accession number KCTC14661BP. One would have been motivated to come to this conclusion since these strains are: (i) species of the same microalgae genus, Schizochytrium; (ii) were developed from parental strains of the same origin (seawater of the west/southwest coast of Korea) and (iii) by the same method of gamma irradiation and produce high amount of bio-oil containing unsaturated fatty acids and therefore strain of Park teaching would be expected to have other properties of the claimed strain. Thus, absent evidence to the contrary, strain of Park teaching is an obvious variant of the claimed strain and hence Park teaching renders claim 1 obvious.
Regarding claim 6, Park teaches microbial preparation for producing bio-oil including DHA containing the strain SHG104 or a culture solution thereof (paragraph 0026). The specification defines “biomass” as: “biomass" means an energy source of bioenergy, that is, a living organism such as a plant, an animal, a microorganism, and the like, and also means the weight or energy amount of a specific living organism present in a unit time and space ecologically. … the biomass may be the Schizochytrium sp. microalgae itself…” (p. 7, 4th paragraph). Therefore, the SHG104 strain of Park represents biomass (elected species) and microbial preparation of the strain corresponds to composition comprising biomass (elected species). Thus, Park teaching renders claims 6 and 7 obvious.
Regarding claim 8, Park teaches that the SHG104 strain or a culture solution of the strain as effective ingredient can be used as feed additive for fish (paragraph 0023, claim 5), thus providing feed composition (elected species). Therefore, Park teaching renders claim 8 obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIOUBOV G KOROTCHKINA whose telephone number is (571)270-0911. The examiner can normally be reached Monday-Friday: 8:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G.K./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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