DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-5 in the reply filed on 11/11/2025 is acknowledged.
Claims 10-13 and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/11/2025.
Priority
This application is a 371 of PCT/CN2021/141993 (12/28/2021) which claims priority to CN202011631250.7 (12/30/2020) as reflected in the filing receipt issued on 11/17/2023.
The certified copy of the foreign priority document is not in English. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 6/30/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 1-5 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding written description, 35 U.S.C. 112(a) and the first paragraph of pre-AlA 35 U.S.C. 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010). To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention (MPEP § 2163(I)).
MPEP 2163(II)(A)(3)(a)(i and ii) states that 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, reduction to drawings, 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.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., .759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
In the instant case, claim 1 recites “a polynucleotide encoding an amino acid sequence of SEQ ID NO: 3 or a homologous sequence thereof”. There is not sufficient written description support for “a homologous sequence thereof”. Homologous sequence is not defined in the specification to indicate how much variation can exist between SEQ ID NO: 3 and a sequence considered to be homologous.
The specification states on page 4 that the term "homology" refers to percentage identity between two polynucleotides or two polypeptides”. Thus, it appears that a homologous sequence as set forth in the instant application would be determined by aligning sequences to determine percent identity.
However, there is nothing in the specification to indicate a particular cutoff or percentage identity at which a sequence would be considered homologous, and thus a homologous sequence includes sequences with any level of percentage identity compared to SEQ ID NO: 3. This encompasses an extremely large number of possible sequences, as there is no specified limit to how many or which amino acid residues a sequence must share with SEQ ID NO: 3 to be to be considered homologous. The specification does not provide examples of any such homologous sequences, there is no disclosure of which positions or residues could be mutated, substituted, deleted, or truncated in SEQ ID NO: 3 to result in a homologous sequence, and there is not sufficient information to allow a skilled artisan to identify sequences that are considered homologous to SEQ ID NO: 3.
For these reasons, it is not clear that applicant was in possession of the full scope of the invention (a bacterium having any of the many possible homologous sequences to SEQ ID NO: 3), and therefore claim 1 fails to comply with the written description requirement.
Claims 2-5 are included in this rejection as they depend on a rejected claim and do not clarify the issue.
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 1-5 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The terms “improved” and “enhanced” in claim 1 are relative terms which render the claim indefinite. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification does not indicate how improvement and enhancement of expression are assessed. There is no disclosure of a degree or threshold at which gene expression would be considered to be enhanced or improved, and it is not clear what the standard or comparison is for determining this. Thus, the scope of claim 1 is unclear.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 1 recites the broad recitation “improved expression”, and the claim also recites “preferably, the improved expression is an enhanced expression of the
polynucleotide encoding an amino acid sequence of SEQ ID NO: 3 or a homologous sequence thereof, or having a point mutation in the polynucleotide encoding an amino acid sequence of SEQ ID NO: 3 or a homologous sequence thereof, or having a point mutation in, and an enhanced expression of the polynucleotide encoding an amino acid sequence of SEQ ID NO: 3 or a homologous sequence thereof” which is the narrower statement of the range/limitation.
Claim 2 recites the broad recitation “alanine at position 24 in the amino acid sequence of SEQ ID NO: 3 is substituted with a different amino acid”, and the claim also recites “preferably, alanine at position 24 is substituted with threonine” which is the narrower statement of the range/limitation.
Claim 4 recites the broad recitation “a mutation to the base at position 70 of a polynucleotide sequence set forth in SEQ ID NO: 1”, and the claim also recites “preferably, the mutation comprises a mutation of the base at position 70 of a polynucleotide sequence set forth in SEQ ID NO: 1 from guanine (G) to adenine (A); preferably, the polynucleotide sequence having a point mutation comprises a polynucleotide sequence set forth in SEQ ID NO: 2” which is the narrower statement of the range/limitation.
Claim 5 recites the broad recitation “a bacterium of the genus Corynebacterium”, and the claim also recites “preferably, Corynebacterium acetoacidophilum, Corynebacterium acetoglutamicum, Corynebacterium callunae, Corynebacterium glutamicum, Brevibacterium flavum, Brevibacterium lactofermentum, Corynebacterium ammoniagenes, Corynebacterium pekinense, Brevibacterium saccharolyticum, Brevibacterium roseum, and Brevibacterium thiogenitalis; more preferably, Corynebacterium glutamicum CGMCC No. 21220 or ATCC 13869” which is the narrower statement of the range/limitation.
The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
For the purposes of examination, it is considered that any limitations following “preferably” are not required.
Claim 5 recites “wherein the bacterium is a bacterium of the genus Corynebacterium”. The claim further recites that the bacterium is preferably Brevibacterium flavum, Brevibacterium lactofermentum, Brevibacterium roseum, and Brevibacterium thiogenitalis. This is unclear, as Brevibacterium strains are not bacteria of the genus Corynebacterium, but rather of the genus Brevibacterium (see specification para. 2). Thus, it is unclear what is meant by this limitation.
Claim 3 is included in this rejection because it depends on a rejected claim and does not clarify the issue.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kalinowski et al., Journal of biotechnology; 104(1-3):5-25, as evidenced by NCBI C. glutamicum ATCC 13032, GenBank: CAF21026.1.
Regarding claim 1, Kalinowski teaches the complete genomic sequence of Corynebacterium glutamicum ATCC 13032, a strain known for production of amino acids such as L-glutamate and L-lysine (Kalinowski “Abstract”). The genome of C. glutamicum ATCC 13032 comprises an amino acid sequence with accession number GenBank: CAF21026.1, which is 100% identical to instant SEQ ID NO: 3 (see NCBI reference, sequence alignment in OA appendix). Therefore, Kalinowski teaches a bacterium with a polynucleotide sequence that encodes SEQ ID NO: 3. The limitations “for generating L-glutamic acid” and “having an improved expression” are functional limitations of the bacterium. Any bacterium having the claimed structure, a polynucleotide encoding an amino acid sequence of SEQ ID NO: 3, is inherently capable of performing these functions. Thus, the Corynebacterium strain according to Kalinowski is capable of generating L-glutamic acid and having improved expression of the polynucleotide encoding SEQ ID NO: 3, and Kalinowski anticipates the bacterium of claim 1.
Regarding claim 3, Corynebacterium glutamicum ATCC 13032 has polynucleotide sequence that is 100% identical to SEQ ID NO: 1, Accession: BX927155.1 locus tag cg2593, bases 30712-30984, encoding an amino acid with a sequence according to SEQ ID NO: 3 (see NCBI reference, sequence alignment in OA appendix).
Regarding claim 5, Kalinowski teaches that the bacterium is Corynebacterium glutamicum (Kalinowski “Abstract”).
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 5 of copending Application No. 18/270,485 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to overlapping subject matter.
Regarding instant claim 1, claim 1 of ‘485 recites a bacterium for generating L-glutamic acid, having an improved expression of a polynucleotide encoding an amino acid sequence of SEQ ID NO: 3 or a homologous sequence thereof. SEQ ID NO: 3 of ‘485 is 24.6% identical to instant SEQ ID NO: 3. The instant application does not define “homologous sequence” in such a way as to limit the degree of similarity for a homologous sequence. Thus, SEQ ID NO: 3 in ‘485 is considered a homologous sequence to instant SEQ ID NO: 3.
Regarding instant claims 3 and 5, all the limitations of these dependent claims are recited in claims 3 and 5 of ‘485.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 5 of copending Application No. 18/270,493 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to overlapping subject matter.
Regarding instant claim 1, claim 1 of ‘493 recites a bacterium for generating L-glutamic acid, having an improved expression of a polynucleotide encoding an amino acid sequence of SEQ ID NO: 3 or a homologous sequence thereof. SEQ ID NO: 3 of ‘493 is 32.1% identical to instant SEQ ID NO: 3. The instant application does not define “homologous sequence” in such a way as to limit the degree of similarity for a homologous sequence. Thus, SEQ ID NO: 3 in ‘493 is considered a homologous sequence to instant SEQ ID NO: 3.
Regarding instant claims 3 and 5, all the limitations of these dependent claims are recited in claims 3 and 5 of ‘493.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 13, and 20 of copending Application No. 18/040,883 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to overlapping subject matter.
Regarding instant claim 1, claim 11 of ‘883 recites a bacterium for generating an L-amino acid, wherein the microorganism comprises a point mutation of the polynucleotide encoding an amino acid sequence of SEQ ID NO: 3. SEQ ID NO: 3 of ‘883 is 29% identical to instant SEQ ID NO: 3. The instant application does not define “homologous sequence” in such a way as to limit the degree of similarity for a homologous sequence. Thus, SEQ ID NO: 3 in ‘883 is considered a homologous sequence to instant SEQ ID NO: 3.
Regarding instant claims 3 and 5, all the limitations of these dependent claims are recited in claims 13 and 20 of ‘883.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32-34 of copending Application No. 18/001,218 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to overlapping subject matter.
Regarding instant claim 1, claim 32 of ‘218 recites a bacterium producing an L-amino acid, comprising a polynucleotide sequence encoding the amino acid sequence shown in SEQ ID NO: 31 with a point mutation. SEQ ID NO: 31 of ‘218 is 28.6% identical to instant SEQ ID NO: 3. The instant application does not define “homologous sequence” in such a way as to limit the degree of similarity for a homologous sequence. Thus, SEQ ID NO: 3 in ‘218 is considered a homologous sequence to instant SEQ ID NO: 3.
Regarding instant claims 3 and 5, all the limitations of these dependent claims are recited in claims 33 and 34 of ‘218.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-5 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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/EMILY F EIX/Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653