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 .
2. Claims 1-23 are pending and under consideration for their full scope.
3. Applicant’s IDS document filed on 03/05/2026 has been considered.
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 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No.11,884,735 (PTO-892; Reference A). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-25 are directed to the same subject matter as instant claims 1-18. The sequences of sequence identification numbers in U.S. Patent No.11,884,735 are identical to the instant sequences in sequence identification numbers over length and sequence.
The reference teachings anticipate the claimed invention.
The recitations of instant claims 19-23 differ from the prior art in the recitation of administering the antibodies to treat cancer in claim 19, including administration in conjunction with another course of therapy as recited in claim 22 and administration in conjunction with a chemotherapy regimen in claim 23.
It would have been obvious to one of ordinary skill in the art at the time of invention to have administered the antibodies to treat cancer including in conjunction with a chemotherapy regimen because the reference pharmaceutical compositions are defined in the reference specification in column 70, lines 38 to column 71 line 6 to be a pharmaceutical composition used for treating cancer. It would have been obvious to combine the pharmaceutical of the prior art with a chemotherapeutic agent because both compositions are to be used in treating cancer and because chemotherapy is the standard cancer treatment. “It is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose … [T]he idea of combining them flows logically from their having been taught in prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
6. Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No.12,590,163 (PTO-892; Reference B). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-24 are directed to methods of using the same compositions as the instant claims and the same methods of treatment as instant claims 19-23.
The sequences of sequence identification numbers in U.S. Patent No.11,884,735 are identical to the instant sequences in sequence identification numbers over length and sequence.
The reference teachings anticipate the claimed invention.
7. Claims 1-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-13, 21-28, 33, 38 and 49-51 of copending Application No. 19/115,975 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 8-13, 21-28, 33, 38 and 49-51 are directed to methods of using the same compositions as the instant claims and the same methods of treatment as instant claims 19-23.
The sequences of sequence identification numbers in copending Application No. 19/115,975 are identical to the instant sequences in sequence identification numbers over length and sequence.
The reference teachings anticipate the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
8. Claims 1-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 9, 11-13, 15, 19, 21, 25, 28-30, 33 and 36-40 of copending Application No. 19/172,869 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 3, 5, 9, 11-13, 15, 19, 21, 25, 28-30, 33 and 36-40 are directed to methods of using the same compositions as the instant claims and the same methods of treatment as instant claims 19-23.
The sequences of sequence identification numbers in copending Application No. 19/172,869 are identical to the instant sequences in sequence identification numbers over length and sequence.
The reference teachings anticipate the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
9. No claim is allowed.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am 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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June 22, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
Prosecution Insights