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 .
DETAILED ACTION
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement (IDS)
At the time of the instant Office action, no information disclosure statement (IDS) had been received.
Status of applications, Amendments, and/or Claims
The Response filed 27 May 2026 has been entered in full. Claims 2-3, 6-9, 14, 21 have been canceled without prejudice or disclaimer, and claims 1, 4, 11, 15 have been amended currently. Claims 10-13, 15-20, 22 have been amended. Claims 10-13, 15-20, 22, previously withdrawn from consideration, stand by withdrawn as rejection is final and proper. Therefore, claims 1, 4-5 are the subjected of this Office Action.
Withdrawn Objections and/or Rejections
The objection to the claim 3 as set forth at pp. 3 of the previous Office action (mailed 27 February 2026) is withdrawn in view of Applicant’s cancellation of claim 3 (mailed 27 May 2026).
The 35 USC § 102 rejection to claims 1, 3, 5 as set forth at pp. 3-6 of the previous Office action (mailed 27 February 2026) is withdrawn in view of Applicant’s cancellation of claim 3 and amendments to claims 1, 4 and dependent claim 5 (mailed 27 May 2026).
Maintained and/or New Objections and/or 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4-5 remain rejected under 35 U.S.C. 103 as being unpatentable over Bathe et al. (US 7618798; hereafter Bathe, PTO-892) in view of Shi et al. (Published January 16, 2020; hereafter Shi; PTO-892).
Bathe teaches mutants of coryneform bacteria which are generated or isolated, which preferably secrete amino acids and which comprise a gene or allele which encodes a polypeptide possessing malate quinone oxidoreductase activity, which is pertinent to claim 1.
Bathe teaches Corynebacterium strains, microorganisms which exhibit an elevated concentration or activity of the malate quinone oxidoreductase variants in the interior of their cells. which is pertinent to claims 1, 4-5.
Bathe teaches “a process for overexpressing the malate quinone oxidoreductases. A process for overexpressing consists, inter alia, in increasing the copy number of a polynucleotide, which encodes a malate quinone oxidoreductase variant by at least one (1) or more copies. Another process according to the invention consists in functionally linking a promoter to the polynucleotide”, which is pertinent to claims 1, 4-5.
Bathe teaches mutants of coryneform bacteria which comprise an mqo allele which encodes a polypeptide which possesses malate quinone oxidoreductase enzyme activity and which comprises the amino acid sequence depicted in SEQ ID NO: 6, SEQ ID NO: 8 or SEQ ID NO: 10, which is pertinent to claims 1, 4-5.
Bathe teaches the mqo allele sequence SEQ ID NO: 9, which is 99.6 % identical to SEQ ID NO: 2. See figure below. Bathe also teaches that SEQ ID NO: 10 is 99.8% identical to SEQ ID NO: 4, which is pertinent to claims 1, 4-5. See Figures below.
Bathe teaches SEQ ID NO: 9 encodes SEQ ID NO: 10, which is pertinent to claims 1, 4-5.
However, Bathe does not explicitly teach the additional mutation present in SEQ ID NOs: 4, 2 as claims 1, 4.
Shi teaches that the complete genome sequence of C. glutamicum TCCC11822 has been deposited at GenBank under accession number CP020033 and the strain is accessible in China General Microbiological Culture Collection Center with an identifier of CGMCC 1.16145. See Figure below regarding genome annotation date and deposit available in NCBI.
The complete genome sequence of C. glutamicum strain TCCC 11822, deposited at Genbank under accession number CP020033.1 taught by Shi has a sequence that has 100% match with SEQ ID NO: 2 (Genbank IDs: B5C28_09640; WP_216312764.1; NP_601207.1). SEQ ID NO: 2 is the DNA sequence encoding the protein sequence in SEQ ID NO: 4, which is pertinent to claims 1 and 4. See figures below (ID: CP020033).
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It would have been obvious to one of ordinary skill in the art to combine the teachings of Bathe and Shi to make a bacterium such as C. glutamicum strain to produce L-glutamic acid. Since Bathe teaches the process for overexpressing the malate quinone oxidoreductase mutants of C. glutamicum with improved performance for production of L-amino acids, such as L-glutamic acid and Shi teaches the C. glutamicum strain TCCC11822, which is a L-glutamate (glutamic acid) high producer strain used in industry, which has SEQ ID NO: 2 encoding the mutated malate quinone oxidoreductase of SEQ ID NO: 4, thereby arriving at the invention of claims 1, 4-5. It would have been obvious to substitute these known equivalents; see MPEP 2144.06.
See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.
Furthermore, In re Kerkhoven (205 USPQ 1069, CCPA 1980) summarizes:
"It is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for the same purpose in order to form a combination that is to be used for the very same purpose: the idea of combining them flows logically from their having been individually taught in the prior art."
Therefore, the invention as a whole would have been prima facie obvious, absent to the contrary. It would have been obvious to substitute these known equivalents; see MPEP 2144.06.
This is a rejection reintroduced in response to the most recent amendment to the claims. Therefore, there are no outstanding arguments directed to this current ground of rejection. Applicant’s arguments directed to the previous 103 for claims 1, 4-5 will be addressed below. See response to arguments.
Response to Arguments
Applicant’s arguments as they pertain to the rejections have been fully considered but are not persuasive for the following reasons.
Applicant argues at pg. 7-9 of the Response (filed 24 April 2026) that 1) that it is non-obvious for people having ordinary skill in the art to modify the teachings of Bathe '338 and make use of the Corynebacterium strain TCCC 11822 of Shi which having the P113S mutation to increase the production of L-amino acids in Corynebacterium strains.
In response to applicant’s argument that there is no teachings, suggestion or motivation to the reference, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where is some teaching, suggestion or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
Applicant should note that Bathe teaches overexpression of malate quinone oxidoreductase enzyme mutants in Corynebacterium glutamicum for production of L-amino acids, including L- glutamic acid and Shi teaches the genome analysis of a temperature-sensitive mutant of Corynebacterium glutamicum TCCC11822 widely used as fermentation strain in L-glutamate industrial production, with improved performance for production of L-glutamate. Shi’s strain has SEQ ID NO: 2, and encodes the mutated malate quinone oxidoreductase P113S (SEQ ID NO: 4). Shi also teaches the comparison of genome of C. glutamicum TCCC11822 and C. glutamicum ATCC 13032 (parental strain). The complete genome sequence of C. glutamicum strain TCCC 11822, deposited at Genbank under accession number CP020033.1 taught by Shi has a sequence that has 100% match with SEQ ID NO: 2 (Genbank IDs: B5C28_09640; WP_216312764.1; NP_601207.1). SEQ ID: 2 is the DNA sequence encoding the protein sequence in SEQ ID NO: 4. See Figure above used for the maintained rejection.
It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Furthermore, in response to applicant's argument that the examiner's conclusion of obviousness is based upon “most fairly be described as teachings” reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon straightforward evidences. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to substitute the overexpression of the malate quinone oxidoreductase enzyme mutants of Bathe by the overexpression of the mutated malate quinone oxidoreductase P113S taught by Shi in a strain of C. glutamicum to produce L-glutamate, as both have been shown to be useful in producing L-amino acids, such as L-glutamic acid.
Applicant argues at pg. 12-13 of Response (filed 24 April 2026) that 1) that Shi is not a proper prior art because although Shi was available to public on January 16, 2020, the nucleotide sequence and strain accession number CP020033 cited by Shi was only available to public on June 15, 2021 and consequently, the genome sequence disclosure is later than the effective filing date of the present application.
Applicant should note that Shi teaches both NCBI and the accessibility to the industrial L-glutamic acid (glutamate) higher producer strain, C. glutamicum TCCC11822 in China General Microbiological Culture Collection Center with an identifier of CGMCC 1.16145. The National Library of Medicine, National Center for Biotechnology Information (NCBI) does accept requesting data status changes such as new versions, withdrawn or suppression of genome annotations and records can be removed or re-annotated.
Since Shi was used as prior art and not the NCBI, and Shi teaches that the genome of C. glutamicum TCCC 11822 is available in the NCBI at the date of the prior art was published. It is considered prior art. In addition, the C. glutamicum TCCC11822 strain was available as well at the time the prior art was available to the public. It would allow one of skill in the art to gather genomic, proteomic, transcriptomic, metabolome and any other omics information from this strain, which is extremely desirable due to its ability to express high levels of L-glutamate at high temperature.
Also, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results".
Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
No claims are allowable. Claims 1, 4-5 remain rejected.
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 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.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PRICILA HAUK TEODORO whose telephone number is (571)272-2784. The examiner can normally be reached M-F 6:15AM-3:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at (571) 272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PRICILA NMN HAUK TEODORO/ Examiner, Art Unit 1645
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684
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