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 .
Status of Claims
Receipt of Arguments/Remarks filed on 5/4/2026 is acknowledged. Claims 1, 3-5, 10-13, and 15-23 are pending. Claims 1, 3-5, and 12 were amended. Claim 2 was canceled. New claims 21-23 were added. Claims 10-13 and 15-20 are withdrawn as being directed to a non-elected invention.
Withdrawn Rejections
The rejection of claims 1, 3, and 5 under 35 U.S.C. § 102 is withdrawn.
The rejections on the ground of nonstatutory double patenting are withdrawn.
New and modified rejections necessitated by amendment
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, 3-5, and 21-23 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.
Claim 1 recites a bacterium with improved L-glutamic acid production, wherein the improved production of L-glutamic acid is caused by having a point mutation in the polynucleotide encoding the amino acid sequence of SEQ ID NO: 3. There is not sufficient written description support for a bacterium having only a point mutation and improved production of L-glutamic acid compared to the unmodified bacterium. Table 5 in the instant specification (p. 37) shows the production of L-glutamic acid by unmodified (Corynebacterium glutamicum CGMCC No. 21220) or various recombinant strains. The bacterium YPG-013 contains a point mutation, G70A (see instant specification p. 28 para. 222). As shown in Table 5 of the results, the unmodified strain production 99.6 g/L of glutamic acid, while YPG-013 produces a lower amount, 98.5 g/L. Modified strains that overexpress the mutated gene or have an increased copy number of the mutated gene (YPG-014, YPG-015, YPG-016, YPG-017) produce a higher amount of glutamic acid than the unmodified strain.
There is nothing in the disclosure to indicate that a strain with only a point mutation in the polynucleotide encoding SEQ ID NO: 3 has improved production of L-glutamic acid. The results in Table 5 indicate that overexpression or increased copy number is required, in addition to the point mutation, as a strain having only a point mutation produced less glutamic acid than wildtype. Thus, it is not clear that applicant was in possession of the full scope of the invention, specifically a strain wherein improved L-glutamic acid production is caused by having a point mutation in the polynucleotide encoding the amino acid sequence of SEQ ID NO: 3.
Claims 3-5 and 21-23 are included in this rejection because 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, 3-5, and 21-23 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 term “improved” in claim 1 is a relative term which renders the claim indefinite. The term “improved” is 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 disclose a degree or threshold at which L-glutamic acid production would be considered to be improved. Specifically, it is not clear if “improved” refers to any increase in the amount of L-glutamic acid compared to the unmodified bacterium, or if there is a certain standard by which an improvement is assessed, such as a statistically significant increase, or a certain percentage increase, for example.
Additionally, claim 1 recites “wherein the point mutation to the polynucleotide encoding the amino acid sequence of SEQ ID NO: 3 causes that alanine at position 24 in the amino acid sequence of SEQ ID NO: 3 is substituted with threonine, or an amino acid sequence having about 98% or higher, or about 99% or higher sequence homology thereto”. This limitation is unclear. Specifically, regarding “or an amino acid sequence having about 98% or higher”, it is not clear what this limitation is an alternative to. It appears that this is meant to recite that alanine is substituted at position 24 of SEQ ID NO: 3; or alternatively alanine is substituted at position 24 of a sequence having 98 or 99% identity to SEQ ID NO: 3. However, this is not clear as written. Additionally, claim 1 recites “wherein the modified protein comprises an amino acid sequence of SEQ ID NO: 3 having a point mutation”, which indicates that the point mutation is only in an amino acid sequence according to SEQ ID NO: 3, not a variant having 98 or 99% identity. The claim should be amended to clarify this issue.
Claim 23 recites “wherein the bacterium comprises Corynebacterium acetoacidophilum, Corynebacterium acetoglutamicum, Corynebacterium callunae, Corynebacterium glutamicum, Brevibacterium flavum, Brevibacterium lactofermentum, Corynebacterium ammoniagenes, Corynebacterium pekinense, Brevibacterium saccharolyticum, Brevibacterium roseum, and
Brevibacterium thiogenitalis.” This limitation is unclear because it appears to indicate that the bacterium comprises all of the claimed species, given the use of “and”. As there is only one bacterium of claim 1, it is unclear how it could comprise all of the listed species. It is suggested that the claim be amended to clarify this, for example:
The bacterium of claim 1, wherein the bacterium is selected from among the group consisting of Corynebacterium acetoacidophilum, Corynebacterium acetoglutamicum, Corynebacterium callunae, Corynebacterium glutamicum, Brevibacterium flavum, Brevibacterium lactofermentum, Corynebacterium ammoniagenes, Corynebacterium pekinense, Brevibacterium saccharolyticum, Brevibacterium roseum, and Brevibacterium thiogenitalis.
Claims 3-5 and 21-22 are included in this rejection because they depend on a rejected claim and do not clarify the issue.
Allowable Subject Matter
Claims 1, 3-5 and 21-23 are free of the prior art. The closest prior art is Kalinowski et al., Journal of biotechnology; 104(1-3):5-25, as evidenced by NCBI C. glutamicum ATCC 13032, GenBank: CAF21026.1.
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”). Therefore, Kalinowski teaches a bacterium with a polynucleotide sequence that encodes SEQ ID NO: 3. 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. 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).
Kalinowski does not teach a bacterium which comprises a polynucleotide having a point mutation encoding a modified protein with amino acid sequence of SEQ ID NO: 3, wherein the point mutation results in a substitution of alanine for threonine at position 24 of SEQ ID NO: 3. Kalinowski does not teach or suggest modifying the polynucleotide sequence encoding SEQ ID NO: 3. However, the claims are rejected under 35 U.S.C. § 112(a) and (b), as set forth above.
Response to Arguments
In light of amendments to the claims, the rejections of claims 1, 3, and 5 under 35 U.S.C. § 102 and on the ground of nonstatutory double patenting have been withdrawn. Kalinowski does not teach the point mutation as now required by claim 1. The copending applications do not recite a bacterium with a sequence according to SEQ ID NO: 3 and having the point mutation as now required by claim 1.
Conclusion
Claims 1, 3-5 and 21-23 are rejected. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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
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