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 .
Election/Restriction
The response filed on 11/14/25 to the restriction requirement of 9/15/25 has been received. Without traverse, Applicant has elected “for: original claims 60-75 (new claims 80-94): The 9G2 antibody (CDRL1 SEQ ID NO: 20, CDRL2 SEQ ID NO: 15, CDRL3 SEQ ID NO: 16, CDRH1 SEQ ID NO: 21, CDRH2 SEQ ID NO: 22, and CDRH3 SEQ ID NO: 23 according to North; variable light chain SEQ ID NO: 40 and variable heavy chain SEQ ID NO: 41); original claims 76-78 (new claims 95-97): The 9G2 antibody (SEQ ID NOs above); and original claim 79 (new claim 98): The 9G2 antibody (SEQ ID NOs above) and the 11D5 antibody (CDRL1 SEQ ID NO: 198, CDRL2 SEQ ID NO: 229, CDRL3 SEQ ID NO: 182, CDRH1 SEQ ID NO: 240, CDRH2 SEQ ID NO: 241, CDRH3 SEQ ID NO: 242 according to North; variable light chain SEQ ID NO: 361 and variable heavy chain SEQ ID NO: 362).”
Claims 80-98 are pending and currently under consideration.
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.
Claims 80-83 and 94 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 54-69 and 73-76 of copending Application No. 17/995085 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
SEQ ID NOs: 334 and 345 of the copending application are scFv constructs generated from the CDRs of anti-CD33 antibody 9G2, are identical to instant SEQ ID NOs: 154 and 155, and comprise instant SEQ ID NOs: 20, 15, 16, 21, 22, 23, 40 and 41.
Instant claims 80-83 are drawn to anti-CD33-binding antibodies and antigen binding fragments thereof and copending claims 54-69 and 73-76 are drawn to CARs comprising the anti-CD33 antigen binding fragments of the instant claims, kits comprising said CARs, cells comprising said CARs, and polynucleotides encoding said CARs. Therefore, copending claims 54-69 and 73-76 are drawn to species of instant claims 80-83 or polynucleotides that would obviously be used to in the cell of copending claim 66 to generate the copending CARs (constructs encompassed by the claims).
In particular regards to instant claim 94, it would be obvious to generate the CARs of the copending claims in compositions comprising a carrier because the copending specification discloses claimed cells comprising recited CARs are concentrated into a carrier during manufacturing the cells ([0218], in particular).
The instant application and the copending application have the same patent term filing date. As stated at MPEP 1490, if the both an application under examination and the reference application have the same patent term filing date, a provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Objections
Claims 84-93 and 95-98 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN E AEDER whose telephone number is (571)272-8787. The examiner can normally be reached M-F 9am-6pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571)270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEAN E AEDER/ Primary Examiner, Art Unit 1642