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 .
Priority
The instant application is a Continuation of U.S. Application No. 17/908,509 (filed 08/31/2022). Acknowledgement is made of Applicants’ claim for benefit of U.S. Application No. 62/984,716 (filed 03/03/2020).
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.
(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)(2) as being anticipated by Thomas, et al. (WO 2020/106916).
Thomas, et al. teaches nucleic acids, AAV transfer cassettes, and plasmids used in the production of recombinant adeno-associated viral vectors (Abstract).
Regarding claim 1: Thomas, et al. teaches an adeno-associated virus (AAV) vector comprising nucleic acids for delivery of a therapeutic transgene to a cell or to a subject in need thereof (par. 0030). Thomas, et al. teaches an embodiment wherein the transgene encodes soluble CD4 for the treatment of AIDS (par. 0072). Thomas, et al. teaches the vector may further comprise a tissue-specific promoter, such as the NKG5 promoter for T cell specific activation (par. 0058). The AAV vector comprising nucleic acid sequences encoding soluble CD4 and an NKG5 promoter reads on the limitations recited in the instant claim.
Claim 1 is rejected under 35 U.S.C. 102(a)(2) and (a)(1) as being anticipated by Meruelo, et al. (WO 2019/173223).
Meruelo, et al. teaches polynucleotides and viral vectors for encoding immune checkpoint proteins (Abstract).
Regarding claim 1: Meruelo, et al. teaches a Sindbis viral vector comprising a polynucleotide that encodes a soluble form of one or more immune checkpoint proteins, e.g., PD-1 (pg. 36; par. 2). Meruelo, et al. teaches administration of said vector results in systemic secretion of the soluble checkpoint protein (e.g., PD-1), wherein the checkpoint protein is then available to bind to its cognate ligand (e.g., PD-L1) on tumor cells, thereby effectively blocking the binding of any endogenous checkpoint protein expressed on T cells to the tumor cell-expressed, interacting ligand (pg. 39; par. 1). The resultant occupation of the tumor cell-expressed ligand by the exogenous soluble checkpoint protein prevents cytotoxic T cells expressing the endogenous form of the protein from binding to the cognate ligand on the tumor cells, allowing T cell cytotoxic activity to be maintained and directed against the tumor cells, which are killed (pg. 39, par. 1). Meruelo, et al. further teaches the vectors may further comprise tissue-specific promoters, e.g., CD4+ T cell-specific promoters (pg. 46; par. 2).
Thus, the Sindbis viral vector comprising a polynucleotide that encodes for soluble PD-1 and a CD4+ T cell-specific promoter reads on the limitations recited in claim 1.
Claim 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zeng, et al. (US 2021/0275589).
Zeng, et al. teaches immune cells comprising a chimeric receptor, a chimeric co-receptor, and/or a co-receptor (Abstract).
Regarding claim 1: Zeng, et al. teaches a vector comprising nucleic acid(s) encoding a chimeric receptor (par. 0197), wherein the chimeric receptor is a chimeric antigen receptor (CAR) (par. 0138); further disclosed is an embodiment wherein the CAR comprises an anti-CCR5 binding moiety and a broadly neutralizing antibody (bNAb) moiety, such as VRC01 or 3BNC117 (par. 0142). Zeng, et al. teaches an embodiment wherein the vector is a viral vector comprising a CMV promoter (pars. 0200, 0203). As VRC01 and 3BNC117 read on the at least one soluble factor limitation recited in the instant claim, and the CMV promoter reads on the T cell-responsive promoter limitation of the instant claim, the viral vector comprising nucleic acids encoding an anti-CCR5 CAR comprising VRC01 or 3BNC117 and a CMV promoter anticipates the limitations recited in claim 1.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/908,509 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1: Copending claim 1 recites a viral vector comprising a therapeutic cargo portion, wherein the therapeutic cargo portion comprises a nucleotide sequence that encodes at least one soluble exogenous factor capable of inhibiting HIV infection, and a T cell-responsive promoter that regulates expression of the nucleotide sequence; this anticipates the limitations recited in instant claim 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GINA PRONZATI whose telephone number is (571)270-5725. The examiner can normally be reached Monday - Friday 9:00a - 5:00p ET.
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/GINA PRONZATI/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633