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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 2/3/2026 has been entered.
The claim amendments filed 1/30/2026 has been entered.
The Information Disclosure Statements submitted 2/3/2026 and 2/16/2026 have been considered.
Claims 1, 7, 18-19, 26, 30, 34, 39-40, 47, 56, 61-62, and 70-71 are pending.
The previous allowability of the claims is withdrawn in view of amendments in co-pending applications.
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 1 and 71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of copending Application No. 17/777,573 (2/18/2026 claim set). Although the claims at issue are not identical, they are not patentably distinct from each other because the anti-Gal3 antibody used in the method of co-pending claim 1 can have CDRs corresponding to those in instant claim 1 (co-pending SEQ ID NOS: 105, 132, 149, 31, 52, and 76 corresponding to instant SEQ ID NOS: 178, 229, 256, 37, 77, 118, respectively) and instant claim 71. These CDRs correspond to antibody 20H5.A3.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. The instant application is junior to the co-pending application.
Claims 1 and 71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 29, 35, 61, 66, and 79 of copending Application No. 18/053,191 (9/18/2025 claim set). Although the claims at issue are not identical, they are not patentably distinct from each other because the anti-Gal3 antibody administered in co-pending claims 29, 61, and 79 can have CDRs corresponding to those in instant claim 1 (corresponding to instant SEQ ID NOS: 37, 77, 118, 178, 229, and 256, respectively) and instant claim 71. These CDRs correspond to antibody 20H5.A3 recited in co-pending claims 29, 61, and 79.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. The co-pending application is junior to the instant application.
Claims 1 and 71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 43, and 49 of copending Application No. 18/578,450 (6/24/2024 claim set). Although the claims at issue are not identical, they are not patentably distinct from each other because the anti-Gal3 antibody administered in co-pending claim 43 can have CDRs corresponding to those in instant claim 1 (corresponding to instant SEQ ID NOS: 37, 77, 118, 178, 229, and 256, respectively) and instant claim 71. These CDRs correspond to antibody 20H5.A3 recited in co-pending claim 49.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. The co-pending application is junior to the instant application.
The art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent No. 12,497,458 claims galectin-3 antibodies that differ from the instant claims. This patent claims priority to WO 2020/160156 which was removed as prior art under 102(a)(1) and 102(a)(2). See 2/2/2024 and 7/29/2024 Office actions. The ‘458 patent is not considered to be prior art in view of the previous exception under 102(a)(2).
U.S. Patent No. 12,281,166 claims galectin-3 antibodies that differ from the instant claims. This patent is related to U.S. Patent Application Publication 2021/0371533 which was removed as prior art under 102(a)(2). See 4/14/2023 Office action. The ‘166 patent is not considered to be prior art in view of the previous exception under 102(a)(2).
Claims 7, 18-19, 26, 30, 34, 39-40, 47, 56, 61-62, and 70 are objected to as depending upon a rejected base claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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, Joanne Hama can be reached at 571-272-2911. 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.
/Marianne P Allen/Primary Examiner, Art Unit 1647
mpa
Prosecution Insights