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 without traverse of Group I (Invention 1) in the reply filed on 08/25/2025 is acknowledged. Claims 5-9,11 and 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.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 1-4, 12 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 1-4, 12 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 “mutant comprising a mutation at least at one or more positions corresponding to positions 293, 294, and 307 of the sequence as shown in SEQ ID NO: 1” which renders the claim vague and indefinite since the specific mutations are not known and not recited in the claim and it is unclear if the mutations are at the recited positions of SEQ ID NO: 1 by recitation of “corresponding to positions”.
Claim 1 recites the phrase “under very high stringent conditions” which renders the claim vague and indefinite since the specific high stringent conditions are not known and have not been recited in the claim.
Dependent claims 2-4 and 12 are also rejected because they do not correct the defect.
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 1-4, 12 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 broad and widely varying genus of polypeptides with aspartate kinase activity, wherein the polypeptide is selected from a group consisting of any one of (i) to (iv): (i) a mutant of the polypeptide having the sequence as shown in SEQ ID NO: 1, compared with the sequence as shown in SEQ ID NO: 1, the mutant comprising a mutation at least at one or more positions corresponding to positions 293, 294, and 307 of the sequence as shown in SEQ ID NO: 1;(ii) a polypeptide having at least 70%, at least 80%, or at least 90% sequence identity with the sequence as shown in (i) and not comprising the polypeptide having the sequence as shown in SEQ ID NO: 1; (iii) a polypeptide encoded by a polynucleotide, the polynucleotide being hybridized with the polynucleotide as shown in (a) or (b) under very high stringent conditions: (a) a polynucleotide encoding a polypeptide having the amino acid sequence as shown in (i); (b) a full-length complementary polynucleotide of (a); (iv) a fragment of the polypeptide as shown in (i), (ii), (iii), the fragment still having aspartate kinase activity. 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 aspartate kinases with the recited mutations encompassed by the claimed genus by actual reduction to practice. 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 the specific polypeptide having at least 70%, at least 80%, or at least 90% sequence identity with the sequence as shown in (i) and the mutations at corresponding positions that still retains aspartate kinase activity.
Hence, the specification does not provide sufficient written description to inform one of ordinary skill in the art that applicants were in possession at the time the application was filed of the claimed genus of polypeptides with aspartate kinase activity, wherein the polypeptide is selected from a group consisting of any one of (i) to (iv): (i) a mutant of the polypeptide having the sequence as shown in SEQ ID NO: 1, compared with the sequence as shown in SEQ ID NO: 1, the mutant comprising a mutation at least at one or more positions corresponding to positions 293, 294, and 307 of the sequence as shown in SEQ ID NO: 1;(ii) a polypeptide having at least 70%, at least 80%, or at least 90% sequence identity with the sequence as shown in (i) and not comprising the polypeptide having the sequence as shown in SEQ ID NO: 1; (iii) a polypeptide encoded by a polynucleotide, the polynucleotide being hybridized with the polynucleotide as shown in (a) or (b) under very high stringent conditions: (a) a polynucleotide encoding a polypeptide having the amino acid sequence as shown in (i); (b) a full-length complementary polynucleotide of (a); (iv) a fragment of the polypeptide as shown in (i), (ii), (iii), the fragment still having aspartate kinase activity.
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.
Claims 1-4, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Accession A0A0U4X276 (16-MAR-2016; PTO 892) in view of WO2015103497 (07/09/2015; IDS filed 12/05/2024),WO2003014330 (02/20/2003; IDS filed 12/05/2024), Bornscheuer et al. (Curr Protoc Protein Sci. 2011 Nov;Chapter 26:Unit26.7; PTO 892), US20110071274 (03/24/2011; PTO 892), Chichili et al. (Protein Sci. 2012 Dec 6;22(2):153–167; PTO 892).
Accession A0A0U4X276 teaches the Corynebacterium glutamicum aspartate kinase having an amino acid sequence that is 100% identical to SEQ ID NO: 1 (see attached record).
The teachings of the reference differ from the claims in that the reference does not teach the claimed aspartate kinase.
WO2015103497 teaches a modified aspartate kinase from Corynebacterium glutamicum (CgAK) that is resistant to feedback inhibition by L-lysine, and uses thereof for producing L-lysine. WO2015103497 teaches several mutations (e.g. at positions 1293, D294) that correlate with the allosteric lysine inhibition of CgAK. See entire publication and claims especially claims 1-23.
WO2003014330 teaches Coryneform bacteria including Corynebacterium glutamicum for producing chemical compounds such as lysine comprising a feedback resistant form of an
aspartate kinase having one or more amino acid substitutions chosen from the group consisting of A279T, A279V, S301 F, T308I, S301 Y, G345D, R320G, T311 I and S381F (see entire publication and claims especially claims 1-43 and SEQ ID NO: 2).
Bornscheuer et al. teach protein engineering strategies to improve or change the properties of proteins, teach concepts for protein engineering using rational design including substitution and/or deletion of amino acids, directed evolution, and combinations of them where different strategies are presented for identifying the best mutagenesis method, how to identify desired variants by screening or selection, and examples for successful applications are shown which enable researchers to choose the most promising tools to solve their protein engineering challenges (see entire publication especially pages 26.7.1- 26.7.10 and Tables 26.7.1, 26.7.2, and 26.7.3).
US20110071274 teaches uses of a His-tag, typically 6-10 consecutive histidines, as a strategy for purifying recombinant proteins via Ni2+ ions (see entire publication and claims especially claims 22-40).
Chichili et al teach linkers in the structural biology of protein–protein interactions where the lengths of linkers vary from 2 to 31 amino acids, optimized for each condition so that the linker does not impose any constraints on the conformation or interactions of the linked partners (see entire publication and abstract especially Table 1 and pages 153-159).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the protein engineering strategies of Bornscheuer et al. on the aspartate kinase of Accession A0A0U4X276 to make the claimed aspartate kinase having the recited amino acid sequence and amino acid substitutions including the substitutions as taught by WO2015103497 and WO2003014330. 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 obtain a modified aspartate kinase that can be used in processes for producing of products including amino acids including lysine. It would have been obvious to further modify the aspartate kinase to comprise a tag as taught by US20110071274 and spacer or linker of Chichili et al as routine experimentation or as desired for enzyme purification and/or stability. One of ordinary skill in the art before the effective filing date of the claimed invention would have a reasonable expectation of success in view of the reference teachings showing the modification of aspartate kinase and use in producing products including amino acids. Hence, the claimed invention as a whole is prima facie obvious.
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
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