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 with traverse of Group I in the reply filed on 3/20/26 is acknowledged. The traversal is on the ground(s) that Applicant’s disagree and the claimed methods provide a special technical feature over Sabin and Fu et al. This is not found persuasive because unsupported assertions are not convincing when evidence and reasoning are required. The teachings of Sabin and Fu et al are of record and not specifically disputed. Further, Applicants election of SEQ ID NO: 7 in the response is noted, however, contrary to applicants assertion, this was not a species election. It was made clear in the Restriction Requirement (page 6) that the election of a chimeric capsid was not a species election. Thus, claims 7 and are withdrawn because they do not recite the elected SEQ ID NO: 7.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7, 8, 11, 15, 20, 30, 34-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on3/20/2026.
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.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 25, 26, 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sabin et al (WO 2020/242984, of record, reference to the corresponding US PGPub document, US 20220241430 A1).
Sabin et al teach AAV capsid proteins and vectors comprising such having chimeric VP1 proteins wherein the chimeric VP1 proteins are non-mammalian (e.g. avian) except for the N-terminal portion (e.g. the PLA2 or VP1 unique region), which is mammalian (e.g. AAV2). See, e.g., the abstract, Fig 1., ¶’s [0143]-[0148]. The chimeric capsids are designed to evade neutralizing antibodies because of the lack of specific antibodies to the chimeras in patients exposed to non-chimeric AAV. This property also renders the chimeric capsid AAVs with a higher gene transfer efficiency than the non-chimeric vectors (abstract, ¶’s [0004], [0009]-[0010]). The AAV vectors carry transgenes that encode missing (e.g. a reporter gene), mutant or therapeutic proteins (¶’s [0184], [0188]).
Allowable Subject Matter
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed.
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/MICHAEL D BURKHART/ Primary Examiner, Art Unit 1638