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 .
Applicant's election with traverse of Invention 1 and “(n) TATCAGTCT” in the reply filed on 12/10/2025 is acknowledged. The arguments filed have been considered but are not found persuasive.
As previously stated EP2993233A1 (03/09/2016; IDS filed 12/05/2024) teaches a modified promoter from the diaminopimelate dehydrogenase gene of Corynebacterium glutamicum which falls within the scope of the claimed invention (see entire publication and claims especially claims 1-7). Thus, the same or corresponding technical feature was known in the prior art and therefore cannot make a contribution over the prior art. Since the inventions lack the same or corresponding special technical feature, then Inventions 1-6 are not so linked as to form a single general inventive concept under PCT Rule 13.1.
Claims 9-13, 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-8, 14, 15 and “(n) TATCAGTCT” are under consideration in this Office Action.
Claim Rejections - 35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA ) 2nd Paragraph
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 1-8, 14, 15 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the phrase “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” which renders the claims vague and indefinite since the specific mutation or mutations at the recited positions are not known and not recited in the claim. Dependent claims 2-8, 14, 15 are also rejected because they do not correct the defect.
Claim 1 recites the phrase “preferably at least 97%, more preferably at least 98%, and most preferably at least 99% sequence identity” which renders the claims vague and indefinite since it is unclear if the claims are limited to 98% or 99% identity by recitation of “preferably”. Dependent claims 2-8, 14, 15 are also rejected because they do not correct the defect.
Claim 3 recites the phrase “wherein the mutant comprises mutated nucleotides at 4, 5, 6, 7, 8 or 9 positions in position 292 to position 300” ” which renders the claims vague and indefinite since the specific mutation or mutations at the recited positions are not known and not recited in the claim.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-8, 14, 15 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a large and widely varying genus of polynucleotides having promoter activity, wherein the polynucleotide is selected from the group shown in any one of the following (i)-(ii): (i) a genus of mutants of a polynucleotide having the sequence as set forth in SEQ ID NO: 9, comprising any mutated nucleotide at one or more positions in position 292 to position 300 of the sequence as set forth in SEQ ID NO: 9; (ii) a genus of polynucleotides having at least 90%, optionally at least 95%, preferably at least 97%, more preferably at least 98%, and most preferably at least 99% sequence identity compared with the sequence as set forth in (i) and does not comprise the sequence as set forth in SEQ ID NO: 9; wherein the mutant has higher promoter activity than that of the polynucleotide having the sequence as set forth in SEQ ID NO: 9; and the nucleotide sequence of the mutant at position 292 to position 300 of the sequence as set forth in SEQ ID NO: 9 is not selected from ATGCATTGT. According to MPEP 2163:
“For each claim drawn to a genus: The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)…”
According to MPEP 2163.02:
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
The specification as originally filed does not disclose a representative number of species of the genus of polynucleotides having promoter activity including mutants of diaminopimelate dehydrogenase gene promoter having promoter activity. The specification as originally filed does not provide a correlation between function and structure to enable one of ordinary skill in the art to predict which nucleotide sequences and structures correlate with enhanced promoter activity as compared to a diaminopimelate dehydrogenase gene promoter having the sequence set forth in SEQ ID NO: 9.
Hence, the specification does not provide sufficient written description to inform one of ordinary skill in the art that applicants at the time the application was filed were in possession of the claimed genus of genus of polynucleotides having promoter activity, wherein the polynucleotide is selected from the group shown in any one of the following (i)-(ii): (i) a genus of mutants of a polynucleotide having the sequence as set forth in SEQ ID NO: 9, comprising any mutated nucleotide at one or more positions in position 292 to position 300 of the sequence as set forth in SEQ ID NO: 9; (ii) a genus of polynucleotides having at least 90%, optionally at least 95%, preferably at least 97%, more preferably at least 98%, and most preferably at least 99% sequence identity compared with the sequence as set forth in (i) and does not comprise the sequence as set forth in SEQ ID NO: 9; wherein the mutant has higher promoter activity than that of the polynucleotide having the sequence as set forth in SEQ ID NO: 9; and the nucleotide sequence of the mutant at position 292 to position 300 of the sequence as set forth in SEQ ID NO: 9 is not selected from ATGCATTGT.
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 1-8, 14, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Accession AXQ12499 (01-OCT-2009; PTO 892) in view of EP2993233A1 (03/09/2016; IDS filed 12/05/2024), US20060003424 (01/05/2006; PTO 892)
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-8, 14, 15 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims [5-9] of copending Application No. 18030228. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims and/or specification of the copending application teach and/or suggest the claimed polynucleotide having promoter activity, wherein the polynucleotide is selected from the group shown in any one of the following (i)-(ii): (i) a mutant of a polynucleotide having the sequence as set forth in SEQ ID NO: 9, 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; (ii) a polynucleotide having at least 90%, optionally at least 95%, preferably at least 97%, more preferably at least 98%, and most preferably at least 99% sequence identity compared with the sequence as set forth in (i) and does not comprise the sequence as set forth in SEQ ID NO: 9; wherein the mutant has higher promoter activity than that of the polynucleotide having the sequence as set forth in SEQ ID NO: 9; and the nucleotide sequence of the mutant at position 292 to position 300 of the sequence as set forth in SEQ ID NO: 9 is not selected from ATGCATTGT. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claim is allowed.
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