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
Claim Status
The amendment on January 23, 2026 is acknowledged. Claims 1-5, 10-13, 15-22 are currently pending. Claims 6-9, 14 are canceled. There are no new claims. Claims 10-13, 15-22 are withdrawn. Claims 1-5 will be examined on the merits herein.
Elections/Restrictions
Applicant’s election of invention of Group I, claims 1-5 in the reply filed on January 23, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 10-13, 15-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, certified English copies have not been filed and therefore the examiner cannot determine if it discloses the now-claimed invention. For the purpose of applying prior art, the effective filing date is December 28, 2021, the date that PCT/CN2021/142015 was filed.
Information Disclosure Statement (IDS)
At the time of the instant Office action, no information disclosure statement (IDS) had been received.
Claim Objections
Claim 3 is objected to because of the following informality:
Claim 3 is reciting “a nucleotide sequence of SEQ ID NO:1”, however it appears to mean “the amino acid sequence of”. “The” is interpreted to mean “this one, and no others” but “A” can mean “a sequence within”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 5 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Bathe et al. US 7618798; hereafter Bathe, PTO-892).
As to claims 1, 3, 5, Bathes teaches “mutants and alleles of the coryneform bacterium mqo gene which encodes malate quinone oxidoreductases which contain any amino acid apart from L-serine at position 111, or a comparable position, in the amino acid sequence, and to processes for fermentatively preparing amino acids, preferably L-lysine, L-tryptophan and L-proline, using bacteria which comprise these alleles”. Bathe also teaches “The nucleotide sequence of the Corynebacterium glutamicum malate quinone oxidoreductase-encoding gene was determined by Molenaar et al. (European Journal of Biochemistry 254: 395-403 (1998)) and is available to the public in the database of the National Center for Biotechnology Information (NCBI) at the National Library of Medicine (Bethesda, Md., USA) under the accession number AJ224946” (8). Bathe also teaches “EP1038969 describes an improvement in the fermentative production of L-amino acids by coryneform bacteria which results from amplifying the mqo gene.” Bathe teaches “The microbial biosynthesis of L-amino acids in coryneform bacteria is a system which is complex and multilayered, being interlinked with a variety of other metabolic pathways in the cell. It is therefore not possible to make any prediction as to whether complete elimination of, or a reduction in, the catalytic activity of the malate quinone oxidoreductase will improve the production of L-amino acids at different steps. It is therefore desirable to also have available malate quinone oxidoreductase variants which differ in the degree of their activity” (12).
Bathe teaches SEQ ID:10 from patent US 7618798 has 100% match with SEQ ID: 3, which is the amino acid sequence encoded by SEQ ID:1. See Figures below.
Bathe teaches “the invention relates to a process for overexpressing the malate quinone oxidoreductases according to the invention. A process according to the invention for overexpressing consists, inter alia, in increasing the copy number of a polynucleotide according to the invention, which encodes a malate quinone oxidoreductase variant in which any proteinogenic amino acid apart from L-serine is present at position 111 or a corresponding position in the encoded amino acid sequence, by at least one (1) or more copies. Another process according to the invention consists in functionally linking a promoter to the polynucleotide” (121).
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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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 4 are rejected under 35 U.S.C. 103 as being unpatentable over Bathe et al US 20060166338 A1; hereafter Bathe, PTO-892) in view of Shi et al. (Published January 16, 2020).
Bathe teaches the mqo allele sequence gene, SEQ ID: 3, Corynebacterium strains, including C. glutamicum and the use of mutated mqo genes for increasing the production of L-amino acids in Corynebacterium strains, which is pertinent to claims 1, 3, 5.
Shi teaches the Corynebacterium glutamicum strain TCCC11822, which is a temperature-sensitive mutant of Corynebacterium glutamicum widely used as the fermentation in L-glutamate industrial production. Shi also teaches that C. glutamicum TCCC 11822 was obtained by repeated random mutation and selection from the wild-type strain C. glutamicum ATCC 13032. Shi teaches that strain TCCC 11822 has the ability to produce high levels of L-glutamate at a temperature of 39 °C, higher than its optimal growth temperature.
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.
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: 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: 4, which is pertinent to claims 2 and 4. See figures below (ID: CP020033).
It would have been obvious to one of ordinary skill in the art to modify the teachings of Bathe and make use of the C. glutamicum strain TCCC 11822 of Shi, which is temperature-sensitive mutant of C. glutamicum with improved performance for production of L-glutamate. Shi’s strain has SEQ ID: 2, and encodes the mutated malate quinone oxidoreductase P113S (SEQ ID: 4). It would be obvious to use an industrial L-glutamic acid (glutamate) higher producer strain, since it is accessible in China General Microbiological Culture Collection Center with an identifier of CGMCC 1.16145 as taught by Shin, thereby arriving at the invention of claims 2, 4. It would have been obvious to substitute these known equivalents; see MPEP 2144.06.
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". In the instant case, the prior art teaches a product that only differs from the claimed invention by the substitution of a single component (i.e. single or few pointed mutations in the polynucleotide of SEQ ID: 1); the substituted elements (i.e. C337T; P113S) were already known and known to function in an industrial L-glutamate producer, Corynebacterium glutamicum strain , therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of recognize genes sequences from the genome of Corynebacterium strains disclosed as being useful for L-glutamic acid production with a reasonable expectation of success (i.e. the substitution of the element would lead to predictable results), particularly because Shi teaches that C. glutamicum strain TCCC 11822 is a L-glutamic acid producer strain used by industry, it would be obvious to incorporate the mutations found in the homologous sequence genes of high L-glutamate producers into SEQ ID: 3 of Bathe. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
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Conclusion
No claim is allowed.
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-3:15PM.
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/PRICILA NMN HAUK TEODORO/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645