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 amendment, reply and affidavit filed June 30, 2026, have been received and entered into the case. Claims 4 and 6 - 8 are canceled; claims 1 - 3 and 5 are pending and have been considered on the merits. All arguments and the affidavit have been fully considered.
Response to Amendment
The amendments to claims 2 and 3 requiring specific nucleotide sequences to code for specific amino acid sequences find proper support in paragraphs 0036 and 0037 of the specification.
Claim Rejections - 35 USC § 112
Previous rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn due to the amendment requiring specific amino acid and nucleotide sequences in claims 1 – 3.
Claim Rejections - 35 USC § 102
Previous rejections under 35 U.S.C. 102a1 and 102a2 as being anticipated by Manchester et al. (WO 2018/213796, cited by US 2020/0263214) are withdrawn due to the amendment requiring the Corynebacterium glutamicum to include a specific amino acid sequence, which is not disclosed by Manchester.
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.
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.
Claim 1 – 3 and 5 remain rejected under 35 U.S.C. 103 as being unpatentable over Manchester et al. (WO 2018/213796, cited by US 2020/0263214) in view of Zeng et al. (EP 2559758).
Regarding claim 1, Manchester teaches a Corynebacterium glutamicum mutant strain having enhanced L-lysine productivity by having improved activity of glyceraldehyde 3-phosphate dehydrogenase (0026).
Manchester does not teach the mutants comprising the claimed SEQ ID NO: 3 or 5. However, Manchester teaches the enzymes are modified and improved by substitution of at least amino acids in the 36 and 37 position of the wild type gene (see search Result 1 and 2, sequences 71 and 73, respectively), specifically L36T and T37K (SEQ ID:71 and SEQ ID:73), indicating that the improved activity is attributed to modifications in these positions. Both SEQ ID NO: 3 and 5 include modifications to amino acid positions 36 and 37. At the time the claims were filed, it would have been obvious to one ordinary skill in the art to modify these positions since the modifications were demonstrated to improve GAPDH activity which enhances L-lysine productivity, as shown by the modifications in these positions (SEQ ID NO: 71 and 73) of Manchester. Further, at the time the claims were filed, modifying positions 36 and 37 in GAPDH was known to increase NADPH availability, which in turn increases L-lysine production in C. glutamicum. In support, Zeng teaches modifying GADPH at positions 36 and 37 to increase L-lysine production in C. glutamicum, wherein specific modifications include L36S and T37K (0019, 0023, 0026), which are the only modifications of claimed SEQ ID NO:3. Thus, at the time the claims were filed, one of ordinary skill in the art would have been motivated by Manchester alone or in combination with Zeng to modify the wild type GAPDH as claimed with a reasonable expectation for successfully obtaining a modified C. glutamicum having enhanced L-lysine production.
Regarding claims 2 and 3, while the combined prior art does not teach the claimed nucleotide sequences for coding the amino acid sequences, it would have been within the purview of one of ordinary skill in the art to optimize the coding sequences as a matter of routine experimentation and practice, absent evidence to the contrary or of unexpected results.
Regarding claim 5, Manchester teaches culturing the C. glutamicum strains in a medium (0316 – 0317) and recovering L-lysine from the medium (0333 – 0340).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant argues that Manchester and Zeng do not teach modifications of the wild type positions 36 and 37, specifically L36S.
However, Zeng expressly teaches L36S and T37K in paragraphs 0023 and 0026, respectively. In paragraph 0023, Zeng states "Preferably, the amino acid at position 36…can be modified by replacing the Leu residue by hydrophilic or positively charged amino acid, such as Ser, Thr, Arg, His, or Lys" (L36S); and at paragraph 0026 "Preferably, however, the Thr or Leu residue in the position that corresponds to amino acid 37 of SEQ ID NO:1 is replaced by Lys…" (T37K).
Applicant argues and provides a declaration comparing L36T mutants to L36S mutants which shows L36S mutants exhibit a 0.3 percent increase in L-lysine production compared to L36T; and L36S+T37K mutants shows a 2.4% increase compared to L36T+T37K mutants; and that these results are unexpectedly superior, demonstrates the mutants are structurally distinct and were not predicted to show the improved activity.
However, the argument and affidavit fail to persuade because Manchester expressly teaches modifying the wild type sequence at positions 36 and 37 to improve GAPDH activity while Zeng expressly teaches the claimed modifications in paragraphs 0023 and 0026. Applicant appears to credit Zeng with only the "even more preferred aspect" rather than all the teachings therein. Moreover, Zeng specifically teaches the L36S+T37K modifications of wild type GAPDH (0023 - 0026) wherein the resulting enzyme "exhibits an increased specificity for NADP compared to the corresponding naturally occurring enzyme" (0019). In this regard, the argued unexpected superior results are, in fact, both expected and predictable considering the combined prior art.
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699
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