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 .
DETAILED ACTION
This Non-Final Office Action is responsive to the communication received 4/10/2026.
Election/Restrictions
Applicant’s election without traverse in the Reply filed on 4/10/2026 of Group II, Claim(s) 43-44 is acknowledged.
Applicant has elected in the Reply filed on 4/10/2026 the following species:
A. the recombinant hybrid AAV capsid protein sequence of SEQ ID NO 47 (claim 44)
Because applicant did not distinctly and specifically point out the supposed errors in the species election requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The Restriction/Election Requirements are thus deemed proper and are made FINAL.
Claims 29-51 are pending.
Claims 29-42 and 45-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the Reply filed on 4/10/2026.
Claims 43-44 are under examination in this Office Action.
Claim Rejections - 35 USC § 102
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.
Claims 43-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilson et al. (11/01/2018) PCT International Patent Application Publication WO 2018/200419 A1 cited in the 12/28/2022 IDS (hereinafter known as "Wilson").
With regards to claims 43-44, Wilson teaches:
a) as in claims 43-44, a recombinant hybrid AAV capsid protein with improved tropism obtainable by a method of preparation of a recombinant hybrid adeno-associated virus (AAV) capsid protein with improved tropism for muscle and/or central nervous system, comprising the steps of a) providing at least two recombinant AAV capsid proteins from different AAV serotypes, an acceptor AAV capsid protein and at least one donor AAV capsid protein, wherein the donor AAV capsid serotype is AAV13 or hybrid AAV2/13; b) replacing at least one hypervariable region (HVR) sequence chosen from HVR1 to HVR10 and HVR12 sequences of the acceptor AAV capsid protein with a different HVR sequence from the corresponding HVR of a donor AAV capsid protein, to obtain a recombinant hybrid AAV capsid protein with improved tropism for muscle compared to at least the parent acceptor AAV capsid protein; which comprises an amino acid sequence of SEQ ID NO: 45 and having at least 85% identity with SEQ ID NO: 47 amino acid sequence, and wherein the variant sequence has no mutations in all the HVR sequence (see SEQ ID NO 45, pages 2 to 16 and 67 to 76 and Examples 1, 3 and 9).
Thus, Wilson anticipates the present claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684
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