Notice of Pre-AIA or AIA Status
The present application, 18143902, (PG-Pub US 20240226330), filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 4, 7, 15, 17-19, 21-23, 25, 26, 28, 30, 32-49 are pending.
Election/Restrictions
All claims are examined. An election to requirement for election of species was made without traverse in the reply filed on 2/2/2026. Applicant elected without traverse as follows: a variant AAV2 capsid polypeptide from group A; the amino acid sequence of SEQ ID NO: 35 from group B; and the nucleic acid sequence encoding GJB2 of SEQ ID NO: 10 from group D. Applicant argues an election with respect to group C is moot in view of the claim amendments cancelling this species group.
Priority
The filing receipt, mailed , states that this application was filed , and claims domestic priority benefit as a CON of PCT/US2021/058255, filed 11/05/2021 which claims benefit of 63/146,269, filed 02/05/2021 and claims benefit of 63/110,697, filed 11/06/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/16/2024 and 10/24/2025 are in compliance with the provisions of 37 CFR 1.97, except that the digital file wrapper appears to missing a copy of the publication of SMITH et al., GeneReviews, 31 pages, July 20, 2023, IDS filed 1/16/2024, non-patent literature citation number 1.
Accordingly, the information disclosure statements are being considered by the examiner, however the IDS, filed 1/16/2024, non-patent literature citation number 1 to the publication of SMITH et al., GeneReviews, 31 pages, July 20, 2023, has been lined out and that particular citation has not been considered by the examiner.
Claim Objections
Claim 4, line 5, is objected to because of the following informalities: Claim 4 states the term “SEO” but should instead use the term –SEQ--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 23 and 44 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.
Dependent Claims 23 and 44, recite the limitation "the tag" in lines 1. There is insufficient antecedent basis for this limitation in the claim because claims 22 and 43, from which claims 23 and 44 depend, respectively, recite both “C-terminal tag” and “N-terminal tag”, and so it is unclear if “the tag” refers to the C-terminal tag or N-terminal tag or both.
Allowable Subject Matter
1. Claims 1, 4, 7, 15, 17-19, 21-23, 25, 26, 28, 30, 32-49 are free of the prior art. The closest prior art of record is Maguire, US 20210079406, which teaches recombinant AAV comprising capsid variant protein, encoding a GJB2 transgene for treating a cause of hearing loss, but does not teach a variant AAV capsid polypeptide comprising an amino acid sequence SEQ ID NOs; 27, 31, or 35, or an amino acid sequence having at least 99% sequence identity thereto, as in independent claims 1 and 4.
2. The allowed claims are 1, 4, 7, 15, 17-19, 21, 23, 25, 26, 28, 30, 32-43, 45-49.
Conclusion
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MARK L. SHIBUYA
Primary Patent Examiner
Art Unit 1631
/MARK L SHIBUYA/Primary Patent Examiner, Art Unit 1631