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, 5-21 are pending in the instant application. Claims 9-13, 16-20 have been withdrawn from further consideration as being drawn to a nonelected invention.
Claims 1, 2, 5-8, 14, 15, 21 and “(n) TATCAGTCT” are under consideration in this Office Action.
In view of the claim amendment and arguments filed 06/24/2026, the previous rejections of the claims under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph; and 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph; and on the ground of nonstatutory obviousness-type double patenting have been withdrawn.
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, 15, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Accession AXQ12499 (01-OCT-2009; reference of record) in view of EP2993233A1 (03/09/2016; IDS filed 12/05/2024), US20060003424 (01/05/2006; reference of record).
The arguments filed 06/24/2026 have been considered but are not persuasive. According to MPEP 2111, 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. Although the arguments state unexpected effects to increase the expression intensities shown by the experiments preformed in the present application, the claims do not recite increased expression intensities compared to the wild type promoter sequence. 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 Corynebacterium glutamicum diaminopimelate dehydrogenase of Accession AXQ12499 to have mutations at one or more positions in position 292 to position 300 as taught by EP2993233A1 and US20060003424 to obtain the recited mutant diaminopimelate dehydrogenase promoter, constructing an expression vector and/or transcription expression cassette to comprise the mutant diaminopimelate dehydrogenase promoter linked to a protein coding gene as taught by EP2993233A1 and US20060003424, and transforming corynebacterium of US20060003424 or Corynebacterium glutamicum ATCC 13032 of US20060003424 to comprise the expression vector and/or transcription expression cassette; 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 mutant diaminopimelate dehydrogenase promoter to express a desired protein or enzyme.
Amending the claims to recite that the claimed polynucleotide having promoter activity recited in claim 1 has enhanced promoter activity of 18 fold or more as compared with that of the wild type promoter comprising the nucleotide sequence of SEQ ID NO: 9 would aid in overcoming the rejection.
The reference teachings and rejection have been restated below.
Accession AXQ12499 teaches Corynebacterium glutamicum diaminopimelate dehydrogenase (ddh) ddh promoter sequence having a nucleotide sequence that is 100% identical to SEQ ID NO: 9 (see attached record).
The teachings of the reference differ from the claims in that the reference does not teach the claimed polynucleotide having promoter activity comprising a mutated nucleotide at one or more positions in position 292 to position 300 of the sequence as set forth in SEQ ID NO: 9
EP2993233A1 (03/09/2016; IDS filed 12/05/2024) teaches a nucleic acid molecule of Corynebacterium glutamicum origin, having an improved promoter activity, which is operably linked to a gene encoding diaminopimelate dehydrogenase, a vector containing the same, a transformant transformed with the vector, and a method for the production of L-lysine using the transformant (see entire publication and claims especially paragraphs [0010]- [0043] and Examples 1-4). EP2993233A1 teach the following in the claims:
1. A promoter of the ddh gene NCBI gene ID NCgl2528 as comprised in SEQ ID NO. 1, wherein the nucleotides CTC
at positions 301 to 303 of SEQ ID NO. 1 are exchanged by the nucleotides TGT.
2. The promoter of claim 1 comprising a nucleic acid sequence which can be amplified from the nucleic acid sequence
as shown in SEQ ID NO. 1 with the primers as shown in SEQ ID NO. 3 and SEQ ID NO. 6.
3. The promoter of claim 1 or 2 comprising the nucleic acid sequence tgtGGTAAGCTCGA as shown in FIG. 2.
4. The promoter of any one of claims 1 to 3, wherein said promoter is comprised in the transformant CA01-0136 as
deposited under Accession Number KCCM10920P.
5. A nucleic acid molecule for gene expression in prokaryotes comprising the promoter of any one of claims 1 to 4.
6. The nucleic acid molecule of claim 5, wherein said promoter is operably linked to a gene encoding diaminopimelate
dehydrogenase.
7. A vector comprising the promoter of any one of claims 1 to 4 and/or the nucleic acid molecule of claim 5 or 6.
8. A host cell containing the promoter of any one of claims 1 to 4, the nucleic acid molecule of claim 5 or 6 and/or the
vector of claim 7.
9. The host cell of claim 8, which is a microorganism.
10. The host cell of claim 8 or 9, which is a prokaryote.
11. The host cell of any one of claims 8 to 10, which is a coryneform bacterium.
12. The host cell of any one of claims 8 to 11, which belongs to the Corynebacterium genus or the Brevibacterium genus.
13. The host cell of any one of claims 8 to 10, which is E. coli.
14. A method for producing lysine comprising fermenting the host cell of any one of claims 8 to 13.
15. The method for the production of lysine of claim 14 that further comprises collecting the produced lysine
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 Corynebacterium glutamicum diaminopimelate dehydrogenase of Accession AXQ12499 to have mutations at one or more positions in position 292 to position 300 as taught by EP2993233A1 and US20060003424 to obtain the recited mutant diaminopimelate dehydrogenase promoter, constructing an expression vector and/or transcription expression cassette to comprise the mutant diaminopimelate dehydrogenase promoter linked to a protein coding gene as taught by EP2993233A1 and US20060003424, and transforming corynebacterium of US20060003424 or Corynebacterium glutamicum ATCC 13032 of US20060003424 to comprise the expression vector and/or transcription expression cassette. 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 mutant diaminopimelate dehydrogenase promoter to enhance or increase expression of a desired protein product where the modified diaminopimelate dehydrogenase promoter has enhanced promoter activity of 18 fold or more compared to the polynucleotide having the sequence of SEQ ID NO: 9. 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.
THIS ACTION IS MADE FINAL 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christian L Fronda whose telephone number is (571)272 0929. The examiner can normally be reached Monday-Thursday and alternate Fridays between 9:00AM-5:00PM.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652
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