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 .
Applicant’s cancellation of claim 7, 9-11and 14-15, amendment of claims 1, 3, 4 and 12, and the addition of new claims 16-23, in the paper of 2/11/2026, is acknowledged. Applicants' arguments filed on 2/11/2026, have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. Claims 1-6, 8, 12, 13, 16-23 are still at issue and are present for examination.
Election/Restrictions
Applicant's election without traverse of the invention of Group I, claims 1-8, to a mutant Corynebacterium, in the paper of 9/29/2025, is acknowledged.
Claims 12-13 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Objections
Claims 18-19 are objected to because of the following informalities:
Claims 18-20 depend from rejected claim 1.
Appropriate correction and/or comment is required.
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.
Claims 16, 17 and 20-23 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 16 is indefinite that it is drawn to the microorganism of the genus Corynebacterium of claim 1, and further recites “the polypeptide having the deletion of amino acids corresponding to positions 431 to 433” while claim 1 recites “a polypeptide having a deletion of amino acids corresponding to positions 431 to 433”. Applicants recitation of “the polypeptide having the deletion…” in claim 16 raises the question of antecedent basis in reference to “the polypeptide having the deletion”. It is suggested that if applicants intent, the recitation in claim 16 be amended to “a polypeptide having a deletion…” to remove any confusion and maintain consistency throughout the claims.
Claim 17 is similarly indefinite, as discussed above for claim 16, in that it is drawn to the microorganism of the genus Corynebacterium of claim 1, and further recites “includes the polynucleotide having the deletion of nucleotides corresponding to positions 1,291 to 1,299” while claim 1 recites “a polynucleotide having a deletion of nucleotides corresponding to positions 1,291 to 1,299”. Applicants recitation of “the polynucleotide having the deletion …” in claim 17 raises the question of antecedent basis in reference to “the polynucleotide having the deletion”. It is suggested that if applicants intent, the recitation in claim 17 be amended to “a polynucleotide having a deletion …” to remove any confusion and maintain consistency throughout the claims.
Claim 20 recites “wherein the microorganism comprises a polypeptide including the amino acid sequence of SEQ ID NO: 1” which compared to instant SEQ ID NO:5 comprises a deletion of residues 430-432 of SEQ ID NO:5. Since claim 21 depends from claim 1 which requires “a polypeptide having a deletion of amino acids corresponding to positions 431 to 433, based on the sequence represented by SEQ ID NO: 5”, the inconsistency between a deletion of positions 431-433 as required in claim 1 and the deletion of residues 430-432 (relative to SEQ ID NO:5) in SEQ ID NO:1 is indefinite.
Claims 21-23 each recite “the amino acid sequence of SEQ ID NO:2” however, SEQ ID NO:2 is a polynucleotide sequence , not an amino acid sequence. It is suggested that these recitations be amended to “the nucleotide sequence of SEQ ID NO:2”.
Claim Rejections - 35 USC § 102
The rejection of claim(s) 1-6 and 8 under 35 U.S.C. 102(a)(1) as being anticipated by Farwick et al. (US 2002/0102669) is withdrawn based upon applicants amendment of the claims in the paper of 2/11/2026.
The rejection of claim(s) 1-6 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peng et al. (Journal of Industrial Microbiology and Biotechnology, Vol 46, pp 67-79, 2019) is withdrawn based upon applicants amendment of the claims in the paper of 2/11/2026.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-6, 8, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ziegler et al. and(US 2023/0399672) and Uniprot Accession No. Q8NMA0, December 2, 2020.
This rejection was stated in the previous office action as it applied to previous claims 1-8. In response applicants have amended the claims and traverse the rejection as it applies to the newly amended claims.
For applicants convenience the original rejection is repeated herein.
Ziegler et al. (US 2023/0399672) teach a number of engineered bacterial strains having a modified genome that provides advantages in maintenance and biosynthetic processes when cultured at large scale. Ziegler et al. teach methods for large-scale fermentation using the bacterial strains and they teach that the strain engineering yields a reduction in cellular responses to micro-environmental stimuli imposed in large scale bioreactors. Ziegler et al. teach genome-modified bacterial strains that reduces energetically wasteful cellular responses during large-scale culture by deletion or inactivation of non-essential genes. Ziegler et al. teach that the deletions or inactivations avoid costly and unnecessary DNA replication, RNA synthesis, protein synthesis, and/or other ATP-intensive cellular processes during large scale culture. Ziegler et al. such gene deletions or inactivations include those coding for flagella components or transcriptional regulators thereof, chemotaxis proteins and regulators thereof, inhibitors of DNA replication, and proteins involved in active transport of sugars other than glucose, among other cellular processes disclosed herein. Ziegler et al. teach that the strains. exhibits a lower cost of maintenance and higher biosynthesis performance under large-scale conditions as compared to a parent strain that does not contain said deletions or inactivations. Ziegler et al. teach that the engineered bacterial strains include a number of different strains including Corynebacterium glutamicum. Ziegler et al. teach that engineered strains comprise for example when the strain is E. coli a deletion of the clpA gene (see claim 42 and supporting text).
Uniprot Accession No. Q8NMA0 discloses the clpA ATP-binding subunit of Corynebacterium glutamicum as a 925 amino acid protein which has greater than 99% sequence identity to instant SEQ ID NO:5. Uniprot Accession No. Q8NMA0 further teaches the encoding polynucleotide for the clpA ATP-binding subunit of Corynebacterium glutamicum.
One of skill in the art before the effective filing date would have been motivated to use the polynucleotide encoding the clpA protein as taught by Uniprot Accession No. Q8NMA0 in the methods taught by Ziegler et al. of deleting genes, associated with energetically wasteful processes such as the clpA gene, from bacterial strains such as Corynebacterium glutamicum to provide advantages in maintenance and biosynthetic processes when the strains are cultured at large scale (claims 1-8). Zeigler et al. teaches such a genetically engineered E. coli bacterial strain wherein the clpA gene is deleted and Ziegler et al. also suggests similar deletions in other strains such as Corynebacterium glutamicum. The expectation of success is high as the level of genetic engineering and recombinant protein expression in the art is high as exemplified by Ziegler et al., who teach all the methodology necessary to achieve the genetically engineered Corynebacterium glutamicum bacterium. Further the sequence required to genetically engineer the deletion of the clpA gene Corynebacterium glutamicum is provided by Uniprot Accession No. Q8NMA0.
Applicants Response
Applicants submit that the combination of the cited references does not teach or suggest each and every element of the present claim.
Applicants submit that in making the rejection, the office alleges that Q8NMAQ discloses the clpAATP-binding subunit which has greater than 99% sequence identity to instant SEQ ID NO: 5. Applicants submit that ,however, Q8NMA0 does not disclose any "polypeptide having a deletion of amino acids corresponding to positions 431 to 433, based on the sequence represented by SEQ ID NO: 5" and/or any "polynucleotide having a deletion of nucleotides corresponding to positions 1,291 to 1,299, based on the sequence represented by SEQ ID NO: 6" as set forth in the present claims. Applicants submit that in addition, Ziegler fails to cure this deficiency because Ziegler is silent regarding any deletion sites currently claimed.
Accordingly, Applicant respectfully requests reconsideration and withdrawal of the above rejection because the combination of the cited references fails to disclose any "polypeptide having a deletion of amino acids corresponding to positions 431 to 433, based on the sequence represented by SEQ ID NO: 5" and/or any "polynucleotide having a deletion of nucleotides corresponding to positions 1,291 to 1,299, based on the sequence represented by SEQ ID NO: 6" as set forth in the present claims.
Applicants further submit that there is no reason to modify the polynucleotide of Q8NMAO to delete the specific site as set forth in the present claims.
Applicant submits that from reading the cited references, one of ordinary skill in the art would have no reason to delete the specific positions of amino acids (431 to 433 based on a sequence represented by SEQ ID NO: 5) or nucleotides (1,291 to 1,299 based on a sequence represented by SEQ ID NO: 6) as set forth in the present claims.
Applicants amendment of the claims and applicants complete argument is acknowledged and has been carefully considered, however, is found nonpersuasive for the reasons previously made of record and for those reasons repeated herein.
Applicants characterization of the disclosure of Q8NMAQ as disclosing the clpA ATP-binding subunit which has greater than 99% sequence identity to instant SEQ ID NO: 5 is acknowledged. In response to applicants submission that Q8NMA0 does not disclose any "polypeptide having a deletion of amino acids corresponding to positions 431 to 433, based on the sequence represented by SEQ ID NO: 5" and/or any "polynucleotide having a deletion of nucleotides corresponding to positions 1,291 to 1,299, based on the sequence represented by SEQ ID NO: 6", while this is acknowledged, the rejection is not based upon the sole disclosure of the teachings of Q8NMAQ. The basis of the obviousness rejection is as stated previously and repeated above, one of skill in the art before the effective filing date would have been motivated to use the polynucleotide encoding the clpA protein as taught by Uniprot Accession No. Q8NMA0 in the methods taught by Ziegler et al. of deleting genes, associated with energetically wasteful processes such as the clpA gene, from bacterial strains such as Corynebacterium glutamicum to provide advantages in maintenance and biosynthetic processes when the strains are cultured at large scale. Zeigler et al. teaches such a genetically engineered E. coli bacterial strain wherein the clpA gene is deleted and Ziegler et al. also suggests similar deletions in other strains such as Corynebacterium glutamicum. The expectation of success is high as the level of genetic engineering and recombinant protein expression in the art is high as exemplified by Ziegler et al., who teach all the methodology necessary to achieve the genetically engineered Corynebacterium glutamicum bacterium. Further the sequence required to genetically engineer the deletion of the clpA gene Corynebacterium glutamicum is provided by Uniprot Accession No. Q8NMA0. While the above may not make obvious a specific deletion within a specific polypeptide, the above does make obvious the microorganism of the genus Corynebacterium modified to include a polynucleotide having a deletion of nucleotides corresponding to positions 1,291 to 1,299, based on the sequence represented by SEQ ID NO: 6 for the reasons previously stated and repeated above. It is noted that a deletion of the complete clpA gene would encompass a polynucleotide having a deletion of nucleotides corresponding to positions 1,291 to 1,299, based on the sequence represented by SEQ ID NO: 6.
Applicants further submission that there is no reason to modify the polynucleotide of Q8NMAO to delete the specific site as set forth in the present claims is not found persuasive for the reasons stated above.
Thus, claim(s) 1-6, 8, 17 remain rejected under 35 U.S.C. 103 as being unpatentable over Ziegler et al. and(US 2023/0399672) and Uniprot Accession No. Q8NMA0, December 2, 2020.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Remarks
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached 6-3 EST Mon-Fri.
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rgh
4/23/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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