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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 5/4/2026 has been entered.
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.
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Claims 1, 2, and 5-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12370253.
The instant claims are directed to a method of treating cells, the method comprising:
(a) positively selecting HIV-specific CD4+ T cells from PBMC isolated from a subject infected with HIV;
(b) contacting the CD4+ T cells with a therapeutically effective amount of a stimulatory agent, wherein the contacting is carried out ex vivo,
wherein the stimulatory agent comprises a peptide, a mixture of peptides, or a vaccine;
(c) transducing the CD4+ T cells ex vivo with a viral delivery system encoding at least one genetic element, wherein the at least one genetic element comprises (i) a sequence having at least 90% sequence identity with SEQ ID NO: 6, and (ii) a sequence having at least 90% sequence identity with SEQ ID NO: 7, wherein the at least one genetic element does not comprise any small RNA targeting HIV sequences other than Vif and Tat; and
(d) culturing the transduced CD4+ T cells for at least 1 day.
The patented claims are directed to a method for treating HIV infection in a subject in need thereof comprising:
(a) ex vivo contacting peripheral blood mononuclear cells (PBMC) isolated from a subject with a stimulatory agent;
(b) transducing the PBMC ex vivo with a viral delivery system encoding at least one genetic element; and
(c) culturing the transduced PBMC for at least 1 day,
wherein the at least one genetic element comprises (i) a sequence having at least 90% sequence identity with SEQ ID NO: 6, (ii) a sequence having at least 90% sequence identity with SEQ ID NO: 7, and (iii) a sequence having at least 90% sequence identity with SEQ ID NO: 97, wherein the at least one genetic element does not comprise any small RNA targeting HIV sequences other than Vif and Tat.
Patented claim 3 is directed to the method above and further comprising infusing transduced CD4+ T cells into a subject.
The specification of the patent teaches that the above method may further include enrichment of the PBMC, for example, by preferably enriching the PBMC for CD4+ T cells (see col. 24, lines 12-24). Thus, the CD4+ T cells of patented claim 3 are obtained by enriching or positively selecting CD4+ T cells from PBMC isolated from the infected subject [step (a) of instant claim 1].
In order to transduce the selected CD4+ T cells, one would have to follow the method steps of patented claim 1:
(b) ex vivo contacting the selected CD4+ T cells with a stimulatory agent;
(c) transducing the selected CD4+ T cells with a viral delivery system encoding at least one genetic element; and
(d) culturing the transduced CD4+ T cells for at least 1 day,
wherein the at least one genetic element comprises (i) a sequence having at least 90% sequence identity with SEQ ID NO: 6, (ii) a sequence having at least 90% sequence identity with SEQ ID NO: 7, and (iii) a sequence having at least 90% sequence identity with SEQ ID NO: 97, wherein the at least one genetic element does not comprise any small RNA targeting HIV sequences other than Vif and Tat.
Instant claims 1 and 2 are taught by patented claims 1 and 3.
Instant claim 5 is taught by patented claim 6.
Instant claim 6 is taught by patented claim 7.
Instant claim 7 is taught by patented claim 8.
Instant claim 10 is taught by patented claim 10.
Regarding instant claims 8 and 9, the patent specification defines the genetic element as being a small RNA, a microRNA, a shRNA or a microRNA cluster (see col. 3, lines 21-36).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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