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 .
Status of Application/Restriction/Claims
Claim 1 submitted on 11/1/2023 is pending and is the subject of the present Official action.
Priority
Applicant’s claim for the benefit of a prior-filed application PRO 63/183,999 and 371 of PCT/US2022/027390 filed on 5/4/2021 and 5/3/2022, respectively, under 35 U.S.C 119(e) or under 35 U.S.C 120, 121 or 365(c) is acknowledged.
Accordingly, the effective priority date of the instant application is granted as 5/4/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/1/2023 was received. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the examiner.
Claim Interpretation
The current claim language describes a recombinant expression cassette “comprising” polynucleotide stuffer sequence of SEQ ID NO: 1, 2,3, 4 or 5 OR “fragments thereof”. According to applicants’ specification, this reads on even a stuffer sequence fragment of 1-10 nucleotides in length (specification, para 5).
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 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 1 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bennett et al. US 2016/0108373, published 4/21/2016 (hereinafter Bennett).
Claim 1: Bennett describes proviral plasmids and the production of recombinant adeno-associated viruses for transgene expression (Bennett, para 3, 5, 10). Bennett describes the incorporation of lambda stuffer sequences which are inserted into the plasmid backbone to form a modular gene expression cassette (Bennett, para 30). Bennett states that a stuffer sequence is a non-coding sequence used to enlarge the back-bone and contains no functional elements from its viral origin. It does not transcribe genes and contains no promoter itself. Bennett exemplifies the case of p618 which is a 5.1 kB sequence derived from lambda phage which acts to increase the size of the proviral plasmid to greater than 8 kb and helps prevent the backbone from being packaged into the rAAV capsid which only has a capacity of 4.7 kb (Bennett, para 72 Figs 2 and 3). As stated in the claim interpretation section, a recombinant expression cassette comprising the polynucleotide stuffer sequence of SEQ ID NO: 1, 2,3, 4 or 5 or fragments thereof reads on even a nucleotide or dinucleotide match in local similarity which is achieved by the p618 stuffer sequence used by Bennett (Bennett, para 72 Figs 2 and 3). Thus, the disclosure of Bennett anticipates the claimed invention.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. ALEXANDER NICOL whose telephone number is (571)272-6383. The examiner can normally be reached on M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached on (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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Alexander Nicol
Patent Examiner
Art Unit 1634
/ALEXANDER W NICOL/Examiner, Art Unit 1634