DETAILED ACTION
Final Rejection
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
2. This application is 371 of PCT/JP2021/029240 filed on 07/30/2021 and claims foreign priority to JP2020-130717 filed on 07/31/2020, JP2020-215454 filed on 12/24/2020 and JP2021-078781 filed on 05/06/2021.
Status of Claims
3. Claims 1-3, 5, and 7-17 as amended and filed on 02/18/2026 are pending.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on 04/10/2023, 10/03/2023, 01/17/2025, and 04/11/2025 are in compliance with the provisions of 37 CFR 1.97 and are considered by the examiner.
Drawings
5. Drawings filed on 01/27/2023 are considered and acknowledged.
Withdrawn Claim Rejections
6. Withdrawn rejection of claims 1, 5 and 8-11 under 35 U.S.C. 102(a)(1) in view of applicant’s amendment to claim 1 filed on 02/18/2026, that also affected scope of the dependent claims 5 and 8-11.
7. Withdrawn rejection of claims 1-3, 5, and 7-11 are rejected under 35 U.S.C. 103 in view of applicant’s amendment to claim 1 filed on 02/18/2026 that also affected scope of the dependent claims 2-3, 5 and 7-11.
Objection to Specification (New)
8. The disclosure is objected to because of the following informalities:
The instant specification (filed on 01/27/2023) para [0043] recites, the mutant gene of SEQ ID NO: 3 comprises T (thymine) to C (cytosine) substitutions at positions 2445, 2448, 4998, 5001 and 6000, and G (guanine) to A (alanine) substitution at position 2539 (i.e., 6 nucleotide substitutions in total) in the nucleotide sequence shown in SEQ ID NO: 1.
The instant SEQ ID NO: 3 has a nucleotide base Adenine (A) at position 2539, and not an amino acid Alanine.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (New)
9. 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.
10. Claims 1 and dependent claims 2-3, 5, and 7-17 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.
11. Claims 1-3, 5, and 7-17 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 instant claim 1 limitation recites the base at position 2539 in the nucleotide sequence shown in SEQ ID NO: 3 is alanine. It is not clear how the nucleic acid (DNA) sequence has an amino acid alanine at position 2539. The instant specification para [0043] also recites at position 2539 in the nucleotide sequence shown in SEQ ID NO: 3 is alanine.
Appropriate correction is required to overcome the rejection.
Claim Interpretation (Modified)
12. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim 1: The instant claim 1 is interpreted to be directed to a recombinant vaccinia virus, which comprises the whole or part of cDNA encoding nonstructural proteins or structural protein derived from SARS-CoV-2, and an expression promoter, wherein the cDNA encoding nonstructural protein is any of DNAs shown in (a) and (b) below: (a) DNA consisting of the nucleotide sequence shown in SEQ ID NO: 3; and (b) DNA consisting of the nucleotide sequence that shares 80% or more identity with DNA consisting of the nucleotide sequence shown in SEQ ID NO: 3 and encodes a nonstructural protein derived from SARS-CoV-2, wherein the DNA of (b) is a DNA in which the bases corresponding to the bases at positions 2445, 2448, 4998, 5001 and 6000 in the nucleotide sequence shown in SEQ ID NO: 3 are cytosine, and the base corresponding to the base at position 2539 in the nucleotide sequence shown in SEQ ID NO: 3 is alanine, wherein the cDNA encoding a structural protein is any of DNAs shown in (c) and (d) below: (c) DNA consisting of the nucleotide sequence shown in SEQ ID NO: 7; and (d) DNA consisting of the nucleotide sequence that shares 80% or more identity with DNA consisting of the nucleotide sequence shown in SEQ ID NO: 7 and encodes a structural protein derived from SARS-CoV-2, wherein the DNA of (d) is a DNA in which the bases corresponding to the bases at positions 99, 102, 2364, 2367, 3213, 3216, 3417 and 3420 in the nucleotide sequence shown in SEQ ID NO: 5 are cytosine. It is interpreted that the applicant is intending to refer SEQ ID NO: 7 and not the SEQ ID NO:5. It is interpreted that part of cDNA encoding nonstructural proteins limitation (b) SEQ ID NO: 3 requires the recited 6 base mutations, and part of cDNA encoding structural proteins limitation (d) SEQ ID NO: 7 requires the recited 8 base mutations.
Allowable Subject Matter
13. The following is a statement of reasons for the indication of allowable subject matter:
Applicant’s amendment (filed on 02/18/2026) of the instant claim 1 reciting the mutations in SEQ ID NO: 3 DNA in which the bases corresponding to the bases at positions 2445, 2448, 4998, 5001 and 6000 in the nucleotide sequence shown in SEQ ID NO: 3 are cytosine, and the base corresponding to the base at position 2539 in the nucleotide sequence shown in SEQ ID NO: 3 is alanine, and SEQ ID NO: 7 DNA in which the bases corresponding to the bases at positions 99, 102, 2364, 2367, 3213, 3216, 3417 and 3420 are cytosine has overcome the prior art of record rejections (including ABSS sequence identity search of record) under 35 U.S.C. 102(a)(1) and 35 U.S.C. 103 of the instant amended claim 1 and dependent claims 2-3, 5, and 7-17.
Response to Arguments
14. Applicant’s arguments / remarks filed on 02/18/2026, with respect to rejections of claims 1, 5 and 8-11 under 35 U.S.C. 102(a)(1), and claims 1-3, 5, and 7-11 under 35 U.S.C. 103 have been fully considered in view of applicant’s amendment to the claim 1 filed on 02/18/2026 that also affected scope of the dependent claims 2-3, 5 and 7-11. The applicant’s arguments / remarks are persuasive in view of the claim 1 amendment and the examples 1-7 and results shown in specification and drawings Figures 18-24 regarding protective efficacy and induction of cellular and neutralizing antibody response to the immunization with the rDIS-S vaccine in cynomolgus monkeys. The prior art-based rejection of the claims under 35 U.S.C. 102(a)(1), and 35 U.S.C. 103 has been withdrawn. The newly added claims 12-17 being dependent on claim 1 are free of prior art. Thus amended claims 1-3, 5, and 7-17 are free of the prior art of record.
Conclusion
15. No claim is allowed.
16. 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).
17. 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 SAMADHAN J JADHAO whose telephone number is (703)756-1223. The examiner can normally be reached M-F 8:00-5:00.
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/SAMADHAN JAISING JADHAO/Examiner, Art Unit 1672
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
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