DETAILED ACTION
Status of Claims
The amendment submitted September 30, 2025 has been entered.
Claims 1-2, 4, 9-11, 13-14, 17-21, 32, 34-35, and 42 are pending.
Claims 3, 5-8, 12, 15-16, 22-31, 33, and 36-41 are/were previously cancelled by Applicant.
Claims 35 and 42 remain withdrawn as explained in the Election/Restrictions section below.
Claims 17-18, 21, 32 were rejoined as explained in the Election/Restrictions section below.
Claims 1-2, 4, 8-11, 13-14, 17-18, 21,20, 32, and 34 are pending and are the subject of this Office Action as explained in the Election/Restrictions section below.
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/Restrictions
Applicant’s election of Group I without traverse, claims 1-2, 4, 8-11, 13-14, 17-23, 31-32 and 34 drawn to a compound of formula (A) or (B) and a pharmaceutical composition comprising a compound of formula (A) or (B), in the reply filed on February 13, 2025 is acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election of compound 33, in Example 2, (shown below), in the reply filed on February 13, 2025 is also acknowledged. However, this original election was not located in Applicant’s specification.
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Consequently, a telephonic interview was conducted on June 4, 2025 with the Attorney of Record, Ricardo J. Moran, to clarify and the election of species was then updated to the first compound, page 46 as shown below.
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Claims 1-2, 4, 8-11, 13-14, 20 and 34 read on the elected species.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election of species has also been treated as an election without traverse (MPEP § 818.01(a)).
For the purposes of compact prosecution, claims 17-18, 21, 32 were rejoined, and the search was expanded to full scope of the claims.
The Examiner notes that claims 21-23 and 31 are cancelled by Applicant.
Claims 35, and 42 remain withdrawn from further consideration pursuant to 37 CFR 1.142 (b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 1-2, 4, 8-11, 13-14, 17-18, 21,20, 32 and 34 are pending and are the subject of this Office Action.
Information Disclosure Statement
No additional information disclosure statements have been submitted.
WITHDRAWN OBJECTIONS
The examiner withdraws objections to the specification, and drawings based on amendments made by Applicant.
WITHDRAWN REJECTIONS
The examiner withdraws rejections to Claims 1-2, 4, 8-11, 13-14, 20 and 34 under 35 U.S.C. 112(a) based on claim amendments by Applicant, which have overcome the rejection.
The examiner withdraws rejections to claims 1-2, 4, 8-11, 13-14, and 34 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being clearly anticipated by Low et al (WO/2018111989 A1)(“Low”) based on claim amendments by Applicant, which have overcome the rejection.
The examiner withdraws rejections to claims 1-2, 4, 8-11, 13-14, 20, and 34 under 35 U.S.C. 103 as being obvious over Low et al (WO/2018111989A1)(“Low”) in view of Pujala et al. (US Patent No. 11,504,364 B2)(“Pujala”) and Haberkorn et al. (WO 2019/154886 A1) (“Haberkorn”) as evidenced by Cheng et al. (Cheng, Hong Sheng, Yun Sheng Yip, Eldeen Kai Yi Lim, Walter Wahli, and Nguan Soon Tan. "PPARs and tumor microenvironment: the emerging roles of the metabolic master regulators in tumor stromal–epithelial crosstalk and carcinogenesis." Cancers 13, no. 9 (2021): 2153), which have overcome the rejection.
MAINTAINED/MODIFIED REJECTIONS
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.
The examiner notes that during the course of prosecution, copending Application No. 17/553,113 was allowed and issued as U.S Patent No. 12,397,069 B2. Consequently, the original provisional nonstatutory double patenting rejection has been updated accordingly.
Claims 1-2, 4, 8-11, 13-14, 17-18, 21,20, 32 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-10 and 14 of U.S. Patent No. 12,397,069 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets recite identical frameworks for conjugates consisting of a FAP inhibitor, linker and Ia inhibitor of a signaling pathway necessary for fibrosis in CAFs, including identical components for FAP inhibitor, linker and Ia inhibitor.
Claim 1 of ‘069 recites a conjugate overlapping in scope to instant claim 1, consisting of a FAP inhibitor, linker, and therapeutic agent effective against CAF.
The cited claims of the instant application and ‘069 differ as ‘069 recites a more specific definition for the linker (“is a bivalent linker comprising at least one amino acid selected from the group consisting of Glu and Cys, or a derivative thereof”); however, this definition encompasses the linkers defined in instant claim 1.
The FAP inhibitor is also more specific for instant claim 1, reciting formula X, whereas claim 1 of ‘069 is broader, reciting simply “a fibroblast activation protein (FAP) inhibitor.” Additionally, claim 1 of ‘069 defines X as “X comprises a near infrared (NIR) dye, a radioactive imaging agent, or a therapeutic agent effective against cancer cells and/or cancer-associated fibroblasts (CAF),” whereas instant claim 1 defines Ia as “an inhibitor of a signaling pathway necessary for fibrosis in cancer-associated fibroblasts (CAFs).” However, although the wording is not the same , the subject matter is overlapping.
Claims 2-3, and 7-10 of ‘069 recite claim limitations that overlap in scope for the FAP inhibitor, linker and therapeutic agent effective for instant claims as exemplified below for the formula for B (top) as recited in claim 2, which is overlapping with instant claim 13 (bottom) for pyridyl Z groups. As aforementioned, the claims differ based on definitions; however, share a similar scope of invention.
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Instant claim 1’s definitions of linker and Ia inhibitor remain inclusive of linkers and X groups recited in claims 1-3, and 7-10 of ‘069.
Claim 14 of ‘069 recites a pharmaceutical composition for the conjugate, which overlaps with instant claim 34, also reciting a pharmaceutical composition for the conjugate, only differing in the conjugate definitions as aforementioned.
Therefore, claims 1-2, 4, 8-11, 13-14, 17-18, 21,20, 32 and 34 are rejected on the ground of nonstatutory double patenting.
Conclusion
Claims 1-2, 4, 8-11, 13-14, 17-18, 21,20, 32 and 34 are pending and are rejected.
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN L. LADD whose telephone number is (703)756-5313. The examiner can normally be reached M-Th, 7:00 am to 5:30 pm EST.
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, James H. Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.L.L./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622