DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 2, 5-20 are pending in the instant application. Claims 9-13, 15-19 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
Claims 1, 2, 5-8, 14, 20, SEQ ID NO: 26, and Corynebacterium glutamicum ATCC 13032 are under consideration in this Office Action.
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 of this title, 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.
Claims 1, 2, 5-8, 14, 20 are rejected under 35 U.S.C. 103 as being unpatentable over GenBank Accession No. CP025533.1("Corynebacterium glutamicum strain ATCC 13032 chromosome, complete genome," December 20, 2017, 317 pages; IDS filed 01/19/2023) in view of US Patent 7608437 (10/27/2009; PTO 892), US20060003424 (01/05/2006; PTO 892).
The arguments filed 06/24/2026 have been considered but are not persuasive. According to MPEP 2111, claims must be given their broadest reasonable interpretation in light of the specification. Thus, while claims must be given their broadest reasonable interpretation consistent with the specification, limitations of the specification cannot be read into the claims to thereby narrow the scope of the claims. The amended claims are not limited to any enhanced promoter activity as compared to a glutamate dehydrogenase gene promoter comprising the nucleotide sequence of SEQ ID NO: 30. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the glutamate dehydrogenase gene promoter of taught by GenBank Accession No. CP025533.1 to have one or more bases mutated as taught and/or suggested by US Patent 7608437 to obtain the recited mutant glutamate dehydrogenase gene promoter having the recited nucleotide sequence including SEQ ID NO: 26, constructing an expression vector to comprise the mutant glutamate dehydrogenase gene promoter as taught by US Patent 7608437, and transforming corynebacterium of US Patent 7608437 or Corynebacterium glutamicum ATCC 13032 of US20060003424 to comprise the mutant glutamate dehydrogenase gene promoter; where one of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this in order to use the modified mutant glutamate dehydrogenase gene promoter to enhance or increase expression of a desired protein product. Hence, the claimed invention as a whole is prima facie obvious. Amending the claims to recite that the recited mutant promoter has enhanced promoter activity as compared to a glutamate dehydrogenase gene promoter comprising the nucleotide sequence of SEQ ID NO: 30 would aid in overcoming the rejection.
The reference teachings and rejection have been stated below.
GenBank Accession No. CP025533.1("Corynebacterium glutamicum strain ATCC 13032 chromosome, complete genome," December 20, 2017, 317 pages; IDS filed 01/19/2023) teaches
genome sequence of Corynebacterium glutamicum ATCC 13032, wherein positions 2201859 to 2202657 have 100% sequence identity to SEQ ID NO: 30 of the instant application, and positions 2200515-2201858 next to the above-mentioned region are glutamate dehydrogenase (see record in IDS filed 01/19/2023). Because positions 2201859 to 2202657 have 100% sequence identity to SEQ ID NO: 30 of the instant application, then this region is deemed to be the gene promoter of glutamate dehydrogenase.
The teachings of the reference differ from the claims in that the reference does not teach the claimed mutant of a glutamate dehydrogenase gene promoter of Corynebacterium glutamicum.
US Patent 7608437 (10/27/2009; PTO 892) teaches that a glutamate dehydrogenase (GDH) promoter of Corynebacterium glutamicum ATCC 13032 is mutated to control the expression of a target gene and enhance the production capacity of arginine, wherein the upstream of GDH has a promoter region, the consensus sequences of -35 and -10 regions of the GDH promoter are mutated, sequences 2-6 are mutated sequences of an original sequence 1, the mutated promoter is linked to GDH gene to construct a plasmid, the plasmid is introduced into wildtype corynebacterium, and the activity of GDH can be increased by at least 4.9 times (see entire patent and claims especially claims 1-2).
US20060003424 teaches method of producing coryneform bacteria having an improved amino acid- or nucleic acid-productivity comprises the steps of introducing a mutation in a promoter sequence of amino acid- or nucleic acid-biosynthesizing genes on a chromosome of a coryneform bacterium to make it close to a consensus sequence or introducing a change in a promoter sequence of amino acid- or nucleic acid-biosynthesizing genes on a chromosome of a coryneform bacterium by gene recombination to make it close to a consensus sequence, to obtain mutants of the coryneform amino acid d- or nucleic acid-producing microorganism, culturing the mutants and select a mutant capable of producing the intended amino acid or nucleic acid in a large amount (see entire publication and claims especially paragraphs [0009]- [0021]. US20060003424 teaches the following coryneform glutamic acid producing microorganism in paragraph [0026]:
Corynebacterium acetoacidophilum ATCC13870
Corynebacterium acetoglutamicum ATCC15806
Corynebacterium callunae ATCC15991
Corynebacterium glutamicum ATCC13032
Brevibacterium divaricatum ATCC14020
Brevibacterium lactofermentum ATCC13869
Corynebacterium lilium ATCC15990
Brevibacterium flavum ATCC14067
Corynebacterium melassecola ATCC17965
Brevibacterium saccharolyticum ATCC14066
Brevibacterium immariophilum ATCC14068
Brevibacterium roseum ATCC13825
Brevibacterium thiogenitalis ATCC19240
Microbacterium ammoniaphilum ATCC15354
Corynebacterium thermoaminogenes AJ12310(FERM 9246)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the glutamate dehydrogenase gene promoter of taught by GenBank Accession No. CP025533.1 to have one or more bases mutated as taught and/or suggested by US Patent 7608437 to obtain the recited mutant glutamate dehydrogenase gene promoter having the recited nucleotide sequence including SEQ ID NO: 26,
constructing an expression vector to comprise the mutant glutamate dehydrogenase gene promoter as taught by US Patent 7608437, and transforming corynebacterium of US Patent 7608437 or Corynebacterium glutamicum ATCC 13032 of US20060003424 to comprise the mutant glutamate dehydrogenase gene promoter. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this in order to use the modified mutant glutamate dehydrogenase gene promoter to enhance or increase expression of a desired protein product as taught by US Patent 7608437 where the modified mutant glutamate dehydrogenase gene promoter has enhanced promoter activity of 2-47 fold or more compared to wild type glutamate dehydrogenase gene having the nucleotide sequence of SEQ ID NO: 30. One of ordinary skill in the art at the time the invention was made would have a reasonable expectation of success because genetically modifying gene promoter to enhance or increase expression of a desired protein product is known in the art as shown by reference teachings. Hence, the claimed invention as a whole is prima facie obvious.
Conclusion
No claim is allowed.
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 extension fee 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 date of this final action.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652
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