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 .
Application Status
This action is written in response to applicant’s correspondence received 1/26/26. Claims 1, 11, 14, 36, 38, 42, and 57-60 are currently pending. Claims 2-10, 12-13, 15-35, 37, 39-41, and 43-56 are cancelled. Claims 57-60 are new. Claims 17-19, 24, and 29-30 were withdrawn from prosecution as being drawn to non-elected subject matter, but are now cancelled. Claims 1, 11, 14, 36, 38, 42, and 57-60 are examined herein.
Election/Restrictions
Applicant’s election without traverse of Group I, original claims 1-2, 8, 11, 14, 36, 38, 42, and 51-56 and species SEQ ID NO: 861 in the reply filed on 03/24/2025 is acknowledged.
Applicant limited independent claims 1 and 11 to one sequence (SEQ ID NO: 861, a 735aa AAV8 variant), which is free of the prior art. Accordingly, the 112(b) rejections for indefiniteness, the improper Markush grouping rejection, 102 rejection of claims 1, 11, 14, 36, 38, and 42 over Schaffer (US20160017295A1; of record) are withdrawn. The 103 rejection of claims 51-56 over Schaffer (US20160017295A1; of record), in view of Liu et al. (US20220339270A1; of record) is withdrawn in view of Applicant’s cancellation of claims 51-56.
Provisional NSDP rejection of claims 1, 11, 14, 36, 38, 42, and 51-56 as being unpatentable over claims 1, 9, and 11 of copending Application No. 18/288216 (reference application) is withdrawn in view of Applicant’s amendment to limit the SEQ ID NOs recited to SEQ ID NO: 861, which is free of the prior art and not listed in the claims of the ‘216 application.
Priority
This application is a CON of 16/341,504 (filed 04/12/2019) – issued PAT 11578340, which is a 371 of PCT/US2017/056614 (filed 10/13/2017) with priority to PRO 62/486,642 (04/18/2017), PRO 62/417,756 (11/04/2016), and PRO 62/408,022 (10/13/2016).
Claim Rejections - 35 USC § 112 – necessitated by amendment
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 38 and 42 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.
Regarding claims 38 and 42, which depend from claims 1 and 11, respectively, it is unclear how the nucleic acid can encode a VP1 capsid protein, a VP2 capsid protein, or a VP3 capsid protein when there is only one nucleic acid sequence recited in the independent claim. Therefore, the claims are indefinite.
Allowable Subject Matter
SEQ ID NO: 861, a 735aa AAV8 variant, appears to be free of the prior art.
The prior art not relied upon is considered pertinent to Applicant’s disclosure. Wilson et al. (US20170028082A1; published 02/02/2017, filed 08/03/2016; cited in the IDS filed 4/3/2023) disclose sequences of novel adeno-associated virus capsids, vectors, and host cells for the production of rAAV particles. Wilson et al. further disclose AAV-mediated delivery of therapeutic and immunogenic genes using the vectors of the invention. Wilson et al. teaches SEQ ID NO: 223 encoding an AAV8 VP1 capsid variant having 99.6% sequence identity to Applicant’s elected SEQ ID NO: 861 (see OA.Appendix for sequence alignment in Non-Final OA mailed 4/11/2025).
Conclusion
Claims 1, 11, 14, 36, 57-60 are allowed.
Claims 38 and 42 are rejected.
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 KHALEDA B HASAN whose telephone number is (571)272-0239. The examiner can normally be reached IFP, Monday - Friday 7:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at (571) 270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KHALEDA B HASAN/Examiner, Art Unit 1636
/BRIAN WHITEMAN/Primary Examiner, Art Unit 1636
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