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 .
1. Claims 2-5, 7-12, 14, 17-23, 25-50, 52-54, 56, 58-64, 66, 68, 69, and 72-75 have been cancelled. Claims 1, 6, 13, 15, 51, 55, 57, 65, 67, and 70 have been amended. Claim 76 is new.
Claims 1, 6, 13, 15, 16, 24, 51, 55, 57, 65, 67, 70, 71, and 76 are pending and under examination.
2. All rejections/objections pertaining to claims 29, 30, 33, 34, 42, 43, 47 are moot because the claims were cancelled with the reply filed on 07/23/2026.
The objections to claims 1, 51, 55, 57, 65, and 67 are withdrawn in response to the amendments filed on 07/23/2026.
The rejection of claims 55, 57, 65, 67, 70, and 71 under 35 U.S.C. 112(b) is withdrawn in response to the amendment replacing the recitation “a reference value” with “non-tumor tissue”.
The obviousness-type rejection set forth in the non-final Office action mailed on 03/12/2026 are withdrawn in response to the provided data evidencing that the claimed combination of anti-DOTA C823/ Proteus-DOTA provides superior results over anti-DOTA scFv/ acrylamidobenzoyl-DOTA taught by Krebs.
New Rejections
Double Patenting
3. 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.
4. Claims 1, 6, 13, 15, 16, 24, 51, 55, 57, 65, 67, 70, 71, and 76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 50, 55-57, 64, 66, 69, and 70 of copending Application No. 18/003,645 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to: (1) the same engineered immune cell comprising a fusion protein between an anti-DOTA antigen binding fragment linked to a transmembrane domain (TM) or GPI anchor and a CAR directed to a target antigen; and (2) to the same methods (tracking/monitoring biodistribution/monitoring viability) by administering the engineered immune cell and the same radiolabeled DOTA hapten. By practicing the methods recited in the application claims, one of skill in the art would have obtained a complex as recited in the instant claim 51. As evidenced by the attached Sequence Alignments, SEQ ID NOs: 1 and 5 recited in the application claim 50 are identical to SEQ ID NOs: 35 and 36 recited in the instant claim 1.
The application specification discloses that: the CAR is CD19 CAR; the CD19 scFv is set forth by SEQ ID NO: 27 or 28; the anti-DOTA antigen binding fragment/TM or GPI anchor fusion and the CD19 CAR are expressed as separate polypeptides (see [0026]; [0132]; Fig. 3). As evidenced by the attached Sequence Alignments, SEQ ID NOs: 27 and 28 are identical to SEQ ID NOs: 3 and 4 recited in the instant claim 16.
The application claims 64 and 70 recite a method for tracking the engineered immune cells in a subject having cancer. One of skill in the art would have reasonably concluded that this method would result in result in the accumulation of the engineered immune cells in the tumors, i.e., in detecting tumors in the subject as recited in the instant claim 55.
Thus, the instant claims and the application claims are obvious variants.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
5. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILEANA POPA whose telephone number is (571)272-5546. The examiner can normally be reached 8:00 am to 4:30 pm.
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/ILEANA POPA/Primary Examiner, Art Unit 1633
