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 .
Detailed Action
This action is in response to the papers filed March 5, 2026.
Amendments
Applicant's response and amendments, filed March 5, 2026, to the prior Office Action is acknowledged. Applicant has cancelled Claims 13-25, and added new claims, Claims 26-31.
Claims 1-12 and 26-31 are pending.
Priority
This application is a continuation of application 16/360,281 filed March 21, 2019, now U.S. Patent 11,236,161, which is a continuation of application 15/315,533 filed on December 1, 2016, now U.S. Patent 10,287,350, which is a 371 of PCT/US2015/033473 filed on June 1, 2015. Applicant’s claim for the benefit of a prior-filed application provisional application 62/006,313, filed on June 2, 2014 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
The Examiner also acknowledges Applicant’s copending application 17/696249, which is a continuation of instant application 17/557,845.
Claim Rejections - 35 USC § 103
1. The prior rejection of Claims 22-25 under AIA 35 U.S.C. 103 as being unpatentable over Morgan et al (U.S. 2014/0037628; of record) in view of Song et al (2012; of record) and Powell et al (U.S. 2015/0225480; priority to October 5, 2012; of record) is withdrawn in light of Applicant’s cancellation of the claims.
2. The prior rejection of Claims 16-21 under AIA 35 U.S.C. 103 as being unpatentable over Morgan et al (U.S. 2014/0037628; of record) in view of Song et al (2012; of record) and Powell et al (U.S. 2015/0225480; priority to October 5, 2012; of record), as applied to Claims 22-25 above, and in further view of Jensen et al (U.S. 2015/0038684; of record), Kufe et al (U.S. 2016/0340442; effective priority to January 29, 2014; of record), and Campbell (U.S. 2006/0292156; of record) is withdrawn in light of Applicant’s cancellation of the claims.
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.
3. Claims 1-12 and 26-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32, 34-38, 40-45 of copending Application No. 17/276,959 (reference application) (claim set filed April 14, 2026).
Instant Claim 1 recites, e.g. a host cell expressing a chimeric antigen receptor comprising the amino acid sequence of SEQ ID NO:1.
Claim 1 of co-pending ‘959 recites a host cell (claim 42) comprising an expression vector (claim 41) encoding a chimeric antigen receptor comprising SEQ ID NO:2, 16, 20, 24, or 28, each of which inherently comprise the amino acid sequence of instant SEQ ID NO:1 (see search results).
Thus, the instant claims directed to SEQ ID NO:1 are either anticipated by and/or obvious variants of the ‘959 claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
4. Claims 1, 3-4, 7, 9-10, and 26-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12,473,359 (formerly co-pending application 17/696,249).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘359 claims (e.g. claims 1, 10, and 29) a chimeric antigen receptor (CAR) comprising the amino acid sequence of SEQ ID NO:1, a nucleic acid encoding said CAR, a host cell comprising said nucleic acid (e.g. claims 4-8, 23-25, and 39-41), and a pharmaceutical composition comprising said cells (e.g. claims 9, 26, and 42), whereby ‘359 SEQ ID NO:1 inherently comprises the amino acid sequence of instant SEQ ID NO:1 (see search results).
Terminal Disclaimer
5. The terminal disclaimer filed on November 15, 2024 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 10,287,350, U.S. Patent No. 11,236,161, and any patent granted upon application 17/696,249 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Conclusion
6. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN K. HILL whose telephone number is (571)272-8036. The examiner can normally be reached 12pm-8pm EST.
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KEVIN K. HILL
Examiner
Art Unit 1638
/KEVIN K HILL/Primary Examiner, Art Unit 1638
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