RESPONSE TO APPLICANT’S AMENDMENT
1. Applicant's amendment, filed 12/22/2025, is acknowledged.
2. Claims 25-27, 33, 37, 39, 42-45, 48, 49, 60-62, 66, and 68-116 are pending.
3. The following new ground of rejections are necessitated by the amendment submitted 12/22/2025.
4. Applicant’s IDS, filed 12/22/2025, is acknowledged.
5. The following is a quotation of 35 U.S.C. 112(a) (Pre-AIA 35 U.S.C. 112, first paragraph):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
6. Claims 60-61, 70-77, 79, 81, 99-112, 114 and 116 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention for the same reasons set forth in the previous Office Action mailed 9/22/2025.
Applicant’s arguments, filed 12/22/2025, have been fully considered, but have not been found convincing.
Applicant points to new data for the claimed anti-Notch2 antibodies further supporting the data.
However, MPEP 716 states that when any claim of an application or a patent under reexamination is rejected or objected to, any evidence submitted to traverse the rejection or objection on a basis not otherwise provided for must be by way of an oath or declaration under this section. A declaration with a verified statement is required from a person in a position to corroborate the data presented in the Remarks. It is not clear who did the work presented in the Remarks.
7. 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.
8. Claims 25-27, 33, 37, 39, 42-45, 48, 49, 60-62, 66, and 68-116 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 23-25, 31, 35-36, 41, 45-46, 51, 54-57, 68-70, 74, and 76-77 of copending Application No. 18155973 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of `973 application are directed to the use of anti-Notch2 antibody conjugates comprising anti-Notch2 antibodies having identical CDRs SEQ ID NO sequences and well as identical VH and VL SEQ ID NO sequences to the instant claims. Also the `973 application claims method of treating muco-obstructive lung diseases such as COPD, cystic fibrosis, primary ciliary dyskinesia, non-cystic fibrosis bronchiectasis and bronchiolitis. The claims of the `973 applicants anticipate the claimed anti-Notch2 antibodies and method of treating muco-obstructive lung diseases. Further, the claims of the `973 application renders the claimed nucleic acid, vectors, host cells and methods of producing the antibodies obvious in view of conventional molecule cloning techniques known in the art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s arguments, filed 12/22/2025, have been fully considered, but have not been found convincing.
Applicant submits that the '973 application has a non-provisional filing date of January 18, 2023 (the filing date of the '973 application). Meanwhile, the present application has an earlier non-provisional filing date of July 16, 2021 (the filing date of International Application No. PCT/US21/41935). Accordingly, the provisional obviousness-type double patenting rejection over the co-pending '973 application should be withdrawn once the present claims are otherwise allowable. See MPEP § 804(B)(1) ("If a 'provisional' nonstatutory double patenting rejection is the only rejection remaining in an application having the earliest effective U.S. filing date (including any benefit claimed under 35 U.S.C. 120, 121, 365(c), or 386(c)) compared to the reference application(s), the examiner should withdraw the rejection in the application having the earliest effective U.S. filing date and permit that application to issue as a patent...").
However, this NS-ODP is not the only rejection of record. Once Applicant overcome all the outstanding rejection of record, the Examiner will withdraw the rejection if the 18155973 is not allowed.
9. No claim is allowed.
10. 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.
11. 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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January 6, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644