RESPONSE TO APPLICANT’S AMENDMENT
1. Applicant's amendment, filed 08/26/2026, is acknowledged.
2. Claims 2, 4-6, 9, 12, 16, 18-19, 21, 37-38, 41, 44-50 are pending and under examination.
3. The following new ground of rejection is necessitated by the amendment submitted 08/26/2026.
4. 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.
5. Claims 2, 4-6, 9, 12, 16, 18-19, 21, 37-38, 41, 44-48 stand and newly added claims 49-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 and 23-24 of copending Application No. 18256578 in view of WO2016044811 for the same reasons set forth in the previous Office Action mailed 10/13/09.
Applicant’s arguments, filed 08/26/2026, have been fully considered, but have not been found convincing.
Applicant submits that WO '811 discloses a CAR targeting an entirely different molecule of interest, interleukin-13Rα2 (IL13Rα2). While WO '811 teaches CD28 costimulatory and hinge domain sequences, a skilled artisan would understand that these are merely well-known sequences used in CAR construct design. Furthermore, it is well established in the unpredictable field of chimeric antigen receptor design, that the individual components of a CAR construct for a target of interest must be specifically optimized and tested in combination. A skilled artisan would recognize that simply swapping a binding domain-specifically, replacing the IL13Rα2 binding domain of WO '811 with the anti- GCC binder of the '578 application-does not provide a reasonable expectation of success. Such a substitution would not inherently generate a functional, stable CAR capable of binding the desired target and successfully treating cancer as disclosed in the present application.
However, it remains the Examiner’s position that those skilled in the art would have had a reason to incorporate the anti-GCC antibodies taught by the `578 application into the CAR construct and express it into cytotoxic CAR-T cell taught by the `811 publication to provide highly specific, MHC-unrestricted recognition of GCC on the surface of cancer cells that can directly recognize and destroy cancer cells.
6. No claim is allowed.
7. 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 extension fee 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 date of this final action.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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October 1, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644
