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 of Group I (claims 1, 2, 9, 11, 14, 20, 22-24, 26-28, 50 and 52) in the reply filed on May 27, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 32, 33, 35, 36, 38, and 53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
The present application is a 35 U.S.C. 371 national stage filing of the International Application No. PCT/US2022/026150, filed April 25, 2022. Applicant’s claim for the benefit of a prior-filed parent provisional application 63/180056 filed on April 26, 2021 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Thus, the earliest possible priority for the instant application is April 26, 2021.
Information Disclosure Statement
The information disclosure statements (both filed May 22, 2024) are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDSs have been considered by the examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 9, 11, 14, 20, 22-24, 26-28, and 50 are rejected under 35 U.S.C. 102(a)(1) or (a)(2) as being anticipated by Kotin et al. (U.S. Patent App. No. 2020/0283794).
The claims are directed to no-end (NE) recombinant adeno-associated virus (rAAV) genomes that include a heterologous gene flanked by rAAV inverted terminal repeats (ITRs) where at least one of the ITRs is truncated (relative to the full length ITR of the same AAV serotype) with between 35 and 95 nucleotides. The specification defines a “no-end” AAV genome as a continuous strand of DNA joined at each end by the AAV ITRs, resulting in a continuous double-stranded DNA molecule. (pg. 8, ll. 26-30). Dependent claims 9, 14 and 28 recite “optional” limitations. Claim 9 recites “optionally wherein the one or more nucleic acid mutations are stabilizing mutations and/or results in more efficient ligation than a truncated AAV ITR which does not comprise said mutation.” Claim 14 recites “optionally wherein the truncated AAV ITR comprises the nucleotide sequence of any one of SEQ ID NOs: 7-11.” Claim 28 recites “optionally wherein: the AAV particle is anAAV serotype 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or 13 particle; the nanoparticle comprises a lipid nanoparticle; or the exosome comprises an exosome-associated rAAV. Each of these “optional” limitations is considered to be definite as the limitation can be present but is not required with this claim language.
With respect to independent claim 1, Kotin et al. teach a no-end rAAV genome including a heterologous gene flanked by ITRs having ITRs that are truncated to between 35 and 95 (para. [0103]). (whole doc, Abstract, claim 1).
With respect to dependent claims 2 and 14 Kotin et al. teach a truncated ITR with 91 nucleotides (SEQ ID No. 540, which is identical to SEQ ID No. 9 of the application), within the claimed 55-95 nucleotides.
With respect to dependent claims 9 and 11, Kotin et al. teach the truncated ITR includes nucleic acid mutations (“where at least one of the first and/or second ITR sequence is mutated with respect to the corresponding wild type AAV2 ITR sequence”). (para. [0179], emphasis added). Kotin et al. further teach that the mutations can stabilizing mutations (para. [0024]).
With respect to dependent claim 20, Kotin et al. teach the heterologous gene is associated with hemophilia A or B. (para. [0418]).
With respect to dependent claim 22 and 50, Kotin et al. teach the heterologous gene encodes Factor VIII. (para. [0256]).
With respect to dependent claims 23 and 24, Kotin et al. teach the NE rAAV includes a liver-specific promoter, such as human alpha 1-antitrypsin (HAAT). (para. [0261])
With respect to claim 26, Kotin et al. teach that both ITRs can be truncated. (paras. [0035], [0037]-[0039]).
With respect to claims 27 and 28, Kotin et al. that the NE rAAV can be formulated in a lipid nanoparticle or as an exosome-associated rAAV. (paras. [320], [0351]).
Conclusion
Claim 52 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. Claim 52 recites an AAV particle including the no-end rAAV genome of claim 1 and an AAV capsid protein. The closest prior art, Kotin et al., explicitly teaches that continuous covalently-closed ends AAV vector DNA is capsid-free, teaching away from modified the teachings in the claimed manner.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA E KNIGHT whose telephone number is (571)272-2840. The examiner can normally be reached Monday-Friday 9-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached at 571-272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TERESA E KNIGHT/Primary Examiner, Art Unit 1634
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