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/Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-3, 6-7, 11, 14, 16-17, 21, 23-27, 30-31 and 66) and species (Rep protein, FKBP and promoter) on 4/30/2026 is acknowledged.
Clams 1-3, 6-7, 11, 14, 16-17, 21, 23-27, 30-31, 33-35, 38, 40, 43, 48-49, 51, 53, 57, 59-64 and 66 are pending. Claims 27, 33-35, 38, 40, 43, 48-49, 51, 53, 57 and 59-64 are currently withdrawn from further consideration pursuant to 37 CFR 1.142 (b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-3, 6-7, 11, 14, 16-17, 21, 23-26, 30-31 and 66 are the subject of the present Official action.
Priority
Applicant’s claim for the benefit of a prior-filed application PRO 63/209,735, PRO 63/350,849 and CON of PCT/US22/33071 filed on 6/11/2021, 6/9/2022 and 6/10/2022, 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 6/11/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/7/2024, 3/25/2025, 3/11/2026, 4/22/2026 and 5/19/2026 were received. The submissions were in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements were 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 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)(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.
Claims 1-3, 6-7, 11, 14, 16-17, 21, 23-26, 30-31 and 66 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gam et al. US 2024/0247283, published 7/15/2024, priority date 5/6/2021 (hereinafter Gam).
Claim 1: Gam describes a method for producing genetically engineered cells for the regulated production of recombinant adeno-associated virus (rAAV) vector particles (Gam, abstract). Gam describes an expression control component comprising a nucleic acid encoding a fusion protein comprising an AAV protein and a degradation domain which acts to regulate the production of the rAAV vector particles (Gam, para 76-78).
Claims 2-3, 6 and 16-17: Gam describes a nucleic acid fusion protein like a Rep protein, linker and degradation domain (Gam, para 60, 78, 82 and Fig 2). Gam provides specific embodiments to Rep78 proteins (Gam, para 12 and claim 1). Gam describes fusion of the degradation domain and the Rep protein at het C or N terminal (Gam, para 20 and 48).
Claim 7: Gam describes degradation domains derived from FKBP (Gam, para 78-79).
Claim 11: Gam describes degradation ligands including TMP and auxin (Gam, para 79).
Claims 14, 30-31: Gam describes the use of HEK293 cel lines which express adenovirus E1 genes (Gam, para 255).
Claim 21: Gam describes the use of HEK293 cel lines which express adenovirus E1 genes (Gam, para 255).
Claim 21, 23: Gam describes introducing a Cap protein AAV gene product into the cell with the same or separate plasmid as the degradation domain fusion protein (Gam, para 60, 63, 71, 80).
Claim 25 and 26: Gam describes the use of regulatory elements such as promoters for controlling expression (Gam, para 127, 229, 261).
Claim 66: Gam experiments with fusing different AAV proteins to the degradation domain in order to control rAAV production (Gram, example 1, para 81, claims 1-3).
Conclusion
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, Christopher Babic can be reached on (571)272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Alexander Nicol
Patent Examiner
Art Unit 1634
/ALEXANDER W NICOL/Examiner, Art Unit 1634
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