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 of Group I, claims 1-4 and species, SEQ ID NO:4, in the reply filed on 01/23/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
This application is a 371 of PCT/KR2021/005509 filed 04/30/2021. 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 applications REPUBLIC OF KOREA 10-2021-0030960 filed 03/09/2021 and REPUBLIC OF KOREA 10-2021-0054313 filed 04/27/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/08/2023 complies with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
Claims 1 and 4 are amended. Claims 2, 3 and 5 are cancelled. Claims 6-8 are new.
Claims 1, 4 and 6-8 are pending (claim set filed 01/23/2026) and are examined on the merits herein.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 recites: “…mutant strain of claim 1, wherein a promoter in which a nucleotide sequence … is substituted from CG to GT”. Applicant is suggested to replace recitation with: either “…strain of claim 1, further comprising a promoter in which a nucleotide sequence … is substituted from CG to GT” or “…strain of claim 1, wherein the mutant strain further comprises a promoter in which a nucleotide sequence … is substituted from CG to GT”.
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 and 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 written description requirement. The claim(s) contains 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is directed to Corynebacterium mutant strain with improved L-lysine producing ability by enhancing the activity of diaminopimelate decarboxylase. The specification defines the “enhancing activity” as increasing the expression levels of genes encoding proteins by newly introducing or enhancing the genes, increasing the activity of protein itself through substitution, insertion or deletion of nucleotide encoding the gene or increasing translation of the gene with all of mentioned above compared to the strain before modification (p. 3, 2nd paragraph). Thus, claim 1 encompasses a very broad genus of mutant strains of Corynebacterium with various modifications of the gene encoding diaminopimelate decarboxylase. This represents a large pool of variant sequences of the gene encoding diaminopimelate decarboxylase with increased activity. The specification does not describe the structure function relationship for the gene encoding diaminopimelate decarboxylase and does not describe nucleotides essential for diaminopimelate decarboxylase or that can be modified without loss of diaminopimelate decarboxylase function or are critical for diaminopimelate decarboxylase function. The specification describes that in “a specific embodiment of the present disclosure, the enhancement of the activity of diaminopimelate decarboxylase may be substitution of one or more bases at -25 to -10 regions upstream from the transcription start site in the promoter sequence of the gene encoding diaminopimelate decarboxylase “ (p. 4, 2nd paragraph). The specification provides examples of the substitution of CG bases in -17 and -18 positions of the promoter sequence of argS-lysA operon wherein lysA gene encodes diaminopimelate decarboxylase, to CT (SEQ ID NO:2), GA (SEQ ID NO:3) and GT (SEQ ID NO:4) (p. 4). The resulting mutant strains showed higher production of L-lysine (p. 14, Table 4). However, no other modifications affecting either expression or translation of diaminopimelate decarboxylase or activity of diaminopimelate decarboxylase itself are described and no other representative species are provided.
Thus, one of ordinary skill in the art would conclude based on the lack of representative number of species for the mutant Corynebacterium strain and the lack of describing the structure function correlation for diaminopimelate decarboxylase gene that the Applicant was not in possession of the claimed genus and that the specification fails to satisfy the requirements of written description under 35 U.S.C. 112 (a).
Claim 8 does not resolve the issue mentioned above and is rejected.
Claims 4, 6 and 7 are directed to specific mutant strains comprising sequence with SEQ ID NO:4 (claims 4 and 7) or/and indicated substitutions in SEQ ID NO:1 (claim 6) or SEQ ID NO:4 (claim 7). Therefore, claims 4, 6 and 7 are not rejected.
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 6 and 7 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.
Claim 6 recites: a nucleotide sequence corresponding to -18 and -17 region of a promoter sequence with SEQ ID NO:1.” Claim 7 recites: “-25 to -10 region” of sequence of SEQ ID NO:4. Although the bases in promoter regions are known to be given negative numbering upstream of the transcription start site, however, since the SEQ ID: 1 and SEQ ID: 4 have numbering from 1 to 200 in the sequence listing, it is not clear how one of ordinary skill in the art can determine the recited positions in the sequences. The scope and boundaries of claims 6 and 7 are not certain making claims 6 and 7 indefinite.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 8 are rejected under 35 U.S.C. 102 (a)(1) and (a) (2) as being anticipated by Park (US 9109242 B2).
Regarding claim 1 and 8, Park teaches Corynebacterium variant with higher than endogenous activity of several enzymes involved in L-lysine production including diaminopimelate decarboxylase (Abstract). Park describes several methods to increase activity of the enzymes involved in L-lysine biosynthesis, including increase in gene copy numbers and introduction of exogenous more potent promoters (column 2, lines 27-31). Park provides working examples of Corynebacterium glutamicum strains producing L-lysine and having increased activity of diaminopimelate decarboxylase compared to unmodified strain (column 18, Table 19). Strain KFCC-10881-CJ4 was created by introduction of the second copy of lysA gene (encoding diaminopimelate decarboxylase) (column 11, lines 62-64) providing 1.8-fold increase in diaminopimelate decarboxylase activity and strain KFCC-10881-PCJ7-5 contains exogenous CJ7 promoter at promoter region of several genes involved in L-lysine production including argSlysA genes (column 17, lines 5-7). That strain has 5.8-fold increase in diaminopimelate decarboxylase activity compared to unmodified C. glutamicum strain. Thus, Park teaching anticipates claims 1 and 8.
Allowable Subject Matter
Claims 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claim 4 is directed to the mutant Corynebacterium strain comprising the nucleotide sequence SEQ ID NO:4 which is a modified sequence of promoter for gene encoding diaminopimelate decarboxylase. It is noted that the sequence with SEQ ID NO:4 is novel and not taught by prior art. The closest prior art of Park teaches the sequence of the gene encoding diaminopimelate decarboxylase comprising sequence with SEQ ID NO:1, the sequence of the endogenous promoter for gene encoding diaminopimelate decarboxylase. However, Park does not teach modification of SEQ ID NO:1 or sequence with SEQ ID NO:4.
Thus, there is no teaching or suggestion to achieve 100% identity to SEQ ID NO:4.
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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