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 .
Applicant’s amendments, filed 8/06/2026, is acknowledged.
Claims 3-11, 14, 17, 18, 21-27, 29, 30, 32, 33, 35, 36, 38, 40-52, and 55-58 are cancelled.
Claims 1, 2, 12, 13, 15, 16, 19, 20, 28, 31, 34, 37, 39, 53, and 54 are currently pending.
Claims 1 and 2 are independent claims.
Claims 13, 37, 39, 54 stand as withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions and/or Species.
Claims 1, 2, 12, 15, 16, 19, 20, 28, 31, 34, and 53 are under examination drawn to a therapeutic conjugate comprising an acutely toxic drug moiety linked to a half-life extension moiety via an enzyme cleavable linker.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/6/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner in its entirety.
In view of the amendments and remarks filed on 8/6/2026, the following rejections remain.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1, 2, 12, 15, 16, 19, 20, 28, 31, 34, and 53 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention. This new grounds of rejection is necessitated by Applicant’s amendments.
The claims are rejected for the same reasons recited in the Office Action mailed on 4/06/2026. The claims have been amended to recite specific structures with the function of “half-life extension moiety”, however the claims still recite a broadly claimed genus of moieties with a partial structure at best and the function of “enzyme cleavable linker” (claims 1, 2, 12, 15, 16, 19, 20, 28, 31, 34, and 53), and claim 12 additionally encompasses a broad genus of linkers with no recited structure and the function of “self-immolative linker of bond” which the instant specification does not provide adequate written description support.
Applicants arguments, filed 8/06/2026, have been fully considered, but have been found to be not convincing.
Applicant argues:
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However, the instant claims encompass a genus of structures the comprise structures that are not disclosed in the instant specification, and there is no teaching in the specification that provides sufficient structure-function relationship to allow one with ordinary skill to visualize/recognize other species of the genus. For example, the instant specification discloses peptide sequences of known oligopeptides that are cleaved by MMP proteases, thrombin, and FAPα serine protease, all of which are specific sequences that are recognized by the proteases. For example, all of the FAPα cleavable sequence examples have a proline in the substrate recognition sequence. No other representative species are disclosed, including linkers with SRS structures that include non-natural amino acid residues, that have the function of “enzyme-cleavable linker”. These limited number of sequences do does not sufficiently represent the broadly claimed genera of linkers with a partial structure at best and the recited function of “enzyme-cleavable linker”. No other cleavable substrates to any of the other listed enzymes in the specification are disclosed, such as other proteases (pg. 44-67).
Furthermore, while Applicant argues that the specification discloses a plan/method for screening for other enzyme-cleavable linkers, and then identifying those that satisfy the claim limitations, but a mere “wish or plan” for obtaining claimed invention is not sufficient. Centocor Ortho Biotech Inc. v. Abbott Laboratories, 97 USPQ2d 1870 (Fed. Cir. 2011).
Claims 1, 2, 12, 15, 16, 19, 20, 28, 31, 34, and 53 do not meet the requirements of 35 U.S.C. 112(a) for written description.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the written description inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.). Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 USPQ2d 1398.
Applicant is invited to point to clear support or specific examples of the claimed invention in the specification as-filed.
It is recommended to amend the claims to recite specific structures with the function of “enzyme-cleavable linker” and “self-immolative linker” to overcome this rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 12, 15, 16, 19, 20, 28, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Bachovchin et al. (U.S. Patent 9,956,297, in Office Action mailed on 4/06/2026) in view of Jenkins et al. (WO2022023540). This new grounds of rejection is necessitated by Applicant’s amendments.
Jenkins et al. claims priority to U.S. Provisional Application 63/059,026 and therefore has an effective filing date of 7/30/2020, which is earlier than the instant effective filing date of 10/30/2020. Additionally, Jenkins et al. has at least one inventor that is not an inventor of the instant application.
Claims 1 and 2 claim a therapeutic agent comprising a therapeutic moiety linked to a half-life extending moiety via an enzyme-cleavable moiety, wherein the therapeutic does not comprise a cell binding moiety that binds to a cell surface protein of a cell with a Kd of 1x10-6 M or less, and wherein the serum half-life of the therapeutic is at least 48 hours (claim 1) or is at least 2-fold longer that the therapeutic without the half-life extending moiety (claim 2), wherein the half-life extension moiety comprises one of SEQ ID NO: 117-127.
Bachovchin et al. teaches FAP-activated proteasome inhibitor therapeutic conjugates comprising a Ser-(d)Ala-Pro FAPα cleavable linker (i.e., “enzyme-cleavable linker”) bound to a proteasome inhibitor (Col. 22, also see below):
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Bachovchin et al. teaches that the proteasome inhibitor drug can also comprise bortezomib (Col. 24, lines 5-10). Bachovchin et al. teaches that proteasome inhibitors such as bortezomib have acute toxicity and can cause toxicities such as peripheral neuropathy and hematologic toxicities (Col. 2, lines 4-8). Bachovchin et al. additionally teaches methods of treating cancer comprising administration of these therapeutic compounds (claims 1 and 2).
Bachovchin et al. does not teach the conjugates linked to half-life extension moiety.
Jenkins et al., in the same field of endeavor, teaches recombinant stefin polypeptide variants hat bind to HSA and act as half-life extension moieties (Abstract). Jenkins et al. teaches that the anti-HSA affimers can be linked to a therapeutic moiety via a linker (Fig. 12A) to extend serum half-life of the therapeutic moiety (Table 8). Jenkins et al. teaches methods of fusing the half-life extension moiety to a therapeutic moiety (Example 8).
Jenkins et al. teaches anti-HSA affimer half-life extension moieties comprising SEQ ID NO: 117, which is 100% identical to instant SEQ ID NO: 117:
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It would have been obvious to one of ordinary skill of the art, before the effective filing date of the instant application, to have modified the conjugate taught by Bachovchin et al. in view of Jenkins et al. to fuse the anti-HSA affimers of Jenkins et al. (i.e., SEQ ID NO: 117 of Jenkins et al.) to the FAPα activatable protease inhibitor of Bachovchin et al. (i.e., the limitations of instant claims 1 and 2) with a reasonable expectation of success, as Jenkins et al. teaches a method of conjugating the anti-HSA affimer to other peptides, and the therapeutic of Bachovchin et al. has a peptide FAPα cleavable peptide moiety that can be fused to the anti-HSA affimer (thus, the conjugate would have the anti-HSA affimer conjugated to the protease inhibitor via the FAPα cleavage site). One would have been motivated to make this change to increase the half-life of the FAPα activatable protease inhibitor of Bachovchin et al., which would reduce the frequency of administration and improve patient compliance and quality of life.
Regarding the functional limitations recited in claims 1 and 2, Jenkins et al. teaches the affimers increase serum half-life to over 100 hours, which is over two-fold than a control (Table 11), meeting the claim limitations.
Regarding claim 12, Bachovchin et al. further teaches the following FAPα cleavable protease inhibitor prodrug formula A-B, wherein A is the FAPα cleavable substrate and B is the proteasome inhibitor moiety (Col. 6, lines 61-33). Bachovchin et al. additionally teaches this formula can further comprise a self-eliminating (i.e., “self-immolative”) linker such as PABC between A and B (Col. 15, lines 45-51). Jenkins et al teaches the anti-HSA affimer half-life extension moiety is fused to a conjugate via a peptide linker (Fig. 12A). Fusion of the affimer of Jenkins et al. to the protease inhibitor prodrug with the self-immolative linker taught by Bachovchin et al. via the FAPα cleavable linker would yield a formula of X-L2-SRS-L2-DM, wherein X is the anti-HSA affimer half-life extension moiety, L2 is a linker, SRS is the FAPα cleavable SRS, L2 is the self-immolative linker, and DM is the proteasome inhibitor drug moiety, meeting the claim limitations.
Regarding instant claims 15, 16, 19, 20, and 28 the FAPα cleavage site taught by Bachovchin et al. is Ser-(d)Ala-Pro, which is an oligopeptide sequence with a C-terminal Pro and is a serine protease recognition site, and the protease inhibitors are cytotoxic, meeting the claim limitations.
Regarding instant claim 28, Bachovchin et al. teaches that the proteasome inhibitors are acutely cytotoxic once activated (Col. 40, lines 44-46): “…pro-drug version of a bortezomib-like cytotoxic agent designed to more selectively target the proteasome in solid tumors…”, meeting the claim limitations.
Regarding instant claim 53, Bachovchin et al. teaches pharmaceutical compositions comprising the therapeutic and an acceptable excipient (Col. 23, lines 1-4).
Applicant’s arguments and amendments are rendered moot in light of this new rejection.
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.
Claims 31 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Bachovchin et al. (supra) in view of Jenkins et al. (supra) as applied to claims 1, 2, 12, 15, 16, 19, 20, 28, and 53 above, and further in view of , and further in view of Walsh et al. (PLoS One. 2013;8(3):e58860. doi: 10.1371/journal.pone.0058860 Epub 2013 Mar 12, in Office Action mailed on 4/06/2026) and Poplawski et al. (J Med Chem. 2011 Apr 14;54(7):2022-8. doi: 10.1021/jm100972f. Epub 2011 Mar 9, in Office Action mailed on 4/06/2026), as evidenced by MCE (Talabostat safety data sheet; file.medchemexpress.com/batch_PDF/HY-13233A/Talabostat-mesylate-SDS-MedChemExpress.pdf, in Office Action mailed on 4/06/2026). This new grounds of rejection is necessitated by Applicant’s amendments.
The combined teachings of Bachovchin et al. and Jenkins et al. are discussed supra. The combined references do not teach the therapeutic moiety as Val-boroPro, which is an iDASH inhibitor with acute toxicity (i.e., the limitations of claims 31-33).
Walsh et al., in the same field of endeavor, teaches Val-boroPro can enhance immune T-cell responses to reduce tumor growth in multiple mouse tumor models (Abstract): “…Val-boroPro has antitumor activity and a novel mechanism of action that involves more robust DC trafficking with earlier priming of T cells…” Walsh et al. teaches that Val-boroPro can lead to tumor regression when administered to solid tumors (Fig. 1 and 2). Walsh et al. further teaches (pg. 12): “…our results demonstrate that the boronic dipeptide Val-boroPro induces T cell-mediated tumor rejection via a novel mechanism that involves accelerated T cell priming and enhanced DC trafficking…Val-boroPro represents a novel class of agent for boosting endogenous antitumor immune responses…”
Poplawski et al., in the same field of endeavor, teaches that Val-boroPro can be incorporated into an activatable form that is cleaved by proteases, including the (d)Ala-Pro substrate recognition sequence (Compound 5):
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Poplawski et al. teaches that Val-boroPro is a FAP inhibitor, and FAP inhibition has anticancer effects (Introduction): “…1 is a relatively nonspecific inhibitor of serine hydrolyses that cleave after proline, inhibiting other members of this group, which include FAP… FAP inhibition has been reported to yield anticancer effects…”
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant application, to have modified the conjugate taught by the combined references of Bachovchin et al. and Jenkins et al. in view of Walsh et al. and Poplawski et al. to have exchange the protease inhibitor therapeutic moiety with Val-boroPro (i.e., the limitations of instant claims 32 and 33) with a reasonable expectation of success, as Poplawski et al. teaches that Val-boroPro can be conjugated to cleavable linkers such as (d)Ala-Pro. One would have been motivated to make this change to make a FAPα-activatable version of the FAPα inhibitor Val-boroPro to treat cancers such as solid tumors.
Applicant’s arguments and amendments are rendered moot in light of this new rejection.
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.
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, 2, 12, 15, 16, 19, 20, 28, and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 9,597,410 (Pat ‘410, in Office Action mailed on 4/06/2026) in view of Jenkins et al. (WO2022023540, in Office Action mailed on 4/06/2026, supra), as evidenced by Bachovchin et al. (U.S. Patent 9,956,297, in Office Action mailed on 4/06/2026, supra). This new grounds of rejection is necessitated by Applicant’s amendments.
Pat ‘410 claims FAP-activated (i.e., “enzyme-cleavable”) proteasome inhibitors comprising a Ser-(d)Ala-Pro FAPα cleavable linker bound to a proteasome inhibitor (claim 3):
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Pat ‘410 additionally teaches methods of treating cancer comprising administration of the therapeutic (claim 22).
Pat ‘410 does not teach the conjugates linked to half-life extension moiety comprising SEQ ID NO: 117.
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘410 in view of Jenkins et al., as evidenced by Bachovchin et al. for the same reasons discussed in the 35 U.S.C. § 103 rejection supra.
Applicant’s arguments and amendments are rendered moot in light of this new rejection.
Claims 31 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 9,597,410 (supra) in view of Jenkins et al. (supra), as evidenced by Bachovchin et al. (supra), as applied to claims 1, 2, 12, 15, 16, 19, 20, 28, and 53 above, and further in view of Walsh et al. (PLoS One. 2013;8(3):e58860. doi: 10.1371/journal.pone.0058860. Epub 2013 Mar 12, in Office Action mailed on 4/06/2026, supra) and Poplawski et al. (J Med Chem. 2011 Apr 14;54(7):2022-8. doi: 10.1021/jm100972f. Epub 2011 Mar 9, in Office Action mailed on 4/06/2026, supra), as evidenced by MCE (Talabostat safety data sheet; file.medchemexpress.com/batch_PDF/HY-13233A/Talabostat-mesylate-SDS-MedChemExpress.pdf, in Office Action mailed on 4/06/2026, supra). This new grounds of rejection is necessitated by Applicant’s amendments.
The invention encompassed by instant claims 1, 2, 12, 15, 16, 19, 20, 28, and 53 is a prima facie obvious variant of the invention claimed by Pat ‘410 in view of Jenkins et al., as evidenced by Bachovchin et al. for the reasons discussed supra. Pat ‘410 in view of Jenkins et al., as evidenced by Bachovchin et al. does not teach the therapeutic moiety as Val-boroPro, which is an iDASH inhibitor with acute toxicity (i.e., the limitations of claims 31 and 34).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by Pat ‘410 in view of Jenkins et al., as evidenced by Bachovchin et al., and further in view of Walsh et al. and Poplawski et al., as evidenced by MCE, for the same reasons discussed in the 35 U.S.C. § 103 rejection supra.
Applicant’s arguments and amendments are rendered moot in light of this new rejection.
Claims 1, 2, 12, 15, 16, 19, 20, 28, and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9,956,297 (Pat ‘297, in Office Action mailed on 4/06/2026) in view of Jenkins et al. (supra), as evidenced by Bachovchin et al. (supra). This new grounds of rejection is necessitated by Applicant’s amendments.
Pat ‘297 claims methods of treating cancer comprising administration of FAP-activated proteasome inhibitors comprising a Ser-(d)Ala-Pro FAPα cleavable linker (i.e., “an enzyme-cleavable linker”) bound to a proteasome inhibitor (claim 2):
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The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘297 in view of Jenkins et al., as evidenced by Bachovchin et al. for the same reasons discussed in the 35 U.S.C. § 103 rejection supra.
Applicant’s arguments and amendments are rendered moot in light of this new rejection.
Claims 31 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9,956,297 (supra) in view of Jenkins et al. (supra), as evidenced by Bachovchin et al. (supra), as applied to claims 1, 2, 12, 15, 16, 19, 20, 28, and 53 above, and further in view of Walsh et al. (supra) and Poplawski et al. (supra), as evidenced by MCE (supra). This new grounds of rejection is necessitated by Applicant’s amendments.
The invention encompassed by instant claims 1, 2, 12, 15, 16, 19, 20, 28, and 53 is a prima facie obvious variant of the invention claimed by Pat ‘297 in view of Jenkins et al., as evidenced by Bachovchin et al. for the reasons discussed supra. Pat ‘297 in view of Jenkins et al., as evidenced by Bachovchin et al. does not teach the therapeutic moiety as Val-boroPro, which is an iDASH inhibitor with acute toxicity (i.e., the limitations of claims 31 and 34).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by Pat ‘297 in view of Jenkins et al., as evidenced by Bachovchin et al., and further in view of Walsh et al. and Poplawski et al., as evidenced by MCE, for the same reasons discussed in the 35 U.S.C. § 103 rejection supra.
Applicant’s arguments and amendments are rendered moot in light of this new rejection.
Claims 1, 2, 12, 15, 16, 19, 20, 28, and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,517,955 (Pat ‘955, in Office Action mailed on 4/06/2026) in view of Jenkins et al. (supra), as evidenced by Bachovchin et al. (supra). This new grounds of rejection is necessitated by Applicant’s amendments.
Pat ‘955 claims methods of treating cancer comprising administration of FAP-activated proteasome inhibitors comprising a Ser-(d)Ala-Pro FAPα cleavable linker (i.e., “an enzyme-cleavable linker”) bound to a proteasome inhibitor (claims 12 and 18):
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The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘955 in view of Jenkins et al., as evidenced by Bachovchin et al. for the same reasons discussed in the 35 U.S.C. § 103 rejection supra.
Applicant’s arguments and amendments are rendered moot in light of this new rejection.
Claims 31 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,517,955 (supra) in view of Jenkins et al. (supra), as evidenced by Bachovchin et al. (supra), as applied to claims 1, 2, 12, 15, 16, 19, 20, 28, and 53 above, and further in view of Walsh et al. (supra) and Poplawski et al. (supra), as evidenced by MCE (supra). This new grounds of rejection is necessitated by Applicant’s amendments.
The invention encompassed by instant claims 1, 2, 12, 15, 16, 19, 20, 28, and 53 is a prima facie obvious variant of the invention claimed by Pat ‘955 in view of Jenkins et al., as evidenced by Bachovchin et al. for the reasons discussed supra. Pat ‘955 in view of Jenkins et al., as evidenced by Bachovchin et al. does not teach the therapeutic moiety as Val-boroPro, which is an iDASH inhibitor with acute toxicity (i.e., the limitations of claims 31 and 34).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by Pat ‘955 in view of Jenkins et al., as evidenced by Bachovchin et al., and further in view of Walsh et al. and Poplawski et al., as evidenced by MCE, for the same reasons discussed in the 35 U.S.C. § 103 rejection supra.
Applicant’s arguments and amendments are rendered moot in light of this new rejection.
Claims 1, 2, 12, 15, 19, 20, 28, and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,065,339 (Pat ‘339, in Office Action mailed on 4/06/2026) in view of Jenkins et al. (supra), as evidenced by Bachovchin et al. (supra). This new grounds of rejection is necessitated by Applicant’s amendments.
Pat ‘339 claims pharmaceutical preparations comprising FAP-activated proteasome inhibitors with an oligopeptide FAPα cleavable group (i.e., the limitations of instant claims 15 and 20, Pat ‘339 claim 1). Pat ‘339 additionally claims the linker comprising Ser-(d)Ala (i.e., the limitations of instant claim 21, Pat ‘339 claim 1).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘339 in view of Jenkins et al., as evidenced by Bachovchin et al. for the same reasons discussed in the 35 U.S.C. § 103 rejection supra.
Applicant’s arguments and amendments are rendered moot in light of this new rejection.
Claims 31 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,065,339 (supra) in view of Jenkins et al. (supra), as evidenced by Bachovchin et al. (supra), as applied to claims 1, 2, 12, 15, 19, 20, 28, and 53 above, and further in view of Walsh et al. (supra) and Poplawski et al. (supra), as evidenced by MCE (supra). This new grounds of rejection is necessitated by Applicant’s amendments.
The invention encompassed by instant claims 1, 2, 12, 15, 19, 20, 28, and 53 is a prima facie obvious variant of the invention claimed by Pat ‘339 in view of Jenkins et al., as evidenced by Bachovchin et al. for the reasons discussed supra. Pat ‘339 in view of Jenkins et al., as evidenced by Bachovchin et al. does not teach the therapeutic moiety as Val-boroPro, which is an iDASH inhibitor with acute toxicity (i.e., the limitations of claims 31 and 34).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by Pat ‘339 in view of Jenkins et al., as evidenced by Bachovchin et al., and further in view of Walsh et al. and Poplawski et al., as evidenced by MCE, for the same reasons discussed in the 35 U.S.C. § 103 rejection supra.
Applicant’s arguments and amendments are rendered moot in light of this new rejection.
Claims 1, 2, 12, 15, 16, 19, 20, 28, and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,214,047 (Pat ‘047, in Office Action mailed on 4/06/2026) in view of Jenkins et al. (supra), as evidenced by Bachovchin et al. (supra). This new grounds of rejection is necessitated by Applicant’s amendments.
Pat ‘047 claims methods of treatment comprising administration of FAP-activated (i.e., “enzyme-cleavable”) proteasome inhibitors comprising a Ser-(d)Ala-Pro FAPα cleavable linker bound to a proteasome inhibitor such as the following (claims 1 and 17):
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The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘047 in view of Jenkins et al., as evidenced by Bachovchin et al. for the same reasons discussed in the 35 U.S.C. § 103 rejection supra.
Applicant’s arguments and amendments are rendered moot in light of this new rejection.
Claims 31 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,214,047 (supra) in view of Jenkins et al. (supra), as evidenced by Bachovchin et al. (supra), as applied to claims 1, 2, 12, 15, 16, 19, 20, 28, and 53 above, and further in view of Walsh et al. (supra) and Poplawski et al. (supra), as evidenced by MCE (supra). This new grounds of rejection is necessitated by Applicant’s amendments.
The invention encompassed by instant claims 1, 2, 12, 15, 16, 19, 20, 28, and 53 is a prima facie obvious variant of the invention claimed by Pat ‘047 in view of Jenkins et al., as evidenced by Bachovchin et al. for the reasons discussed supra. Pat ‘047 in view of Jenkins et al., as evidenced by Bachovchin et al. does not teach the therapeutic moiety as Val-boroPro, which is an iDASH inhibitor with acute toxicity (i.e., the limitations of claims 31 and 34).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by Pat ‘047 in view of Jenkins et al., as evidenced by Bachovchin et al., and further in view of Walsh et al. and Poplawski et al., as evidenced by MCE, for the same reasons discussed in the 35 U.S.C. § 103 rejection supra.
Applicant’s arguments and amendments are rendered moot in light of this new rejection.
Claims 1, 2, 15, 19, 20, and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,121,505 (Pat ‘505, in Office Action mailed on 4/06/2026) in view of Jenkins et al. (supra), as evidenced by Bachovchin et al. (supra). This new grounds of rejection is necessitated by Applicant’s amendments.
Pat ‘505 claims pharmaceutical preparations comprising FAP-activated akt inhibitors with an oligopeptide FAPα cleavable group comprising (d)Ala-Pro (i.e., the limitations of instant claims 15, 16, 19, and 20, Pat ‘505 claim 3).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by Pat ‘505 in view of Jenkins et al., as evidenced by Bachovchin et al. for the same reasons discussed in the 35 U.S.C. § 103 rejection supra.
Applicant’s arguments and amendments are rendered moot in light of this new rejection.
Claims 28, 31, and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,121,505 (supra) in view of Jenkins et al. (supra), as evidenced by Bachovchin et al. (supra), as applied to claims 1, 2, 15, 19, 20, and 53 above, and further in view of Walsh et al. (supra) and Poplawski et al. (supra), as evidenced by MCE (supra). This new grounds of rejection is necessitated by Applicant’s amendments.
The invention encompassed by instant claims 1, 2, 15, 19, 20, and 53 is a prima facie obvious variant of the invention claimed by Pat ‘505 in view of Jenkins et al., as evidenced by Bachovchin et al. for the reasons discussed supra. Pat ‘505 in view of Jenkins et al., as evidenced by Bachovchin et al. does not teach the therapeutic moiety as Val-boroPro, which is an iDASH inhibitor with acute toxicity (i.e., the limitations of claims 31 and 34).
The instantly claimed invention is a prima facie obvious variant of the invention claimed by Pat ‘505 in view of Jenkins et al., as evidenced by Bachovchin et al., and further in view of Walsh et al. and Poplawski et al., as evidenced by MCE, for the same reasons discussed in the 35 U.S.C. § 103 rejection supra.
Applicant’s arguments and amendments are rendered moot in light of this new rejection.
Claims 1, 2, 12, 15, 16, 19, 20, 28, 31, 34, and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8, 9, 12-15, 19-22, 25, 26, 31-33, 36, and 52 of copending Application No. 18/034,225 (herein App ‘225). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1 and 2, App ‘225 claims conjugates comprising a drug moiety linked to an anti-HSA half-life extension moiety via a FAPα-cleavable linker (i.e., “an enzyme-cleavable linker”), wherein the circulating serum half-life is at least 48 hours (claim 1), or elevated by more that 2-fold relative to the drug moiety without the half-life extension moiety (claim 2). App ‘225 additionally claims acutely toxic drug moieties (claim 31). App ‘225 further claims the half-life extension moiety comprising SEQ ID NO: 117, which is 100% identical to instant SEQ ID NO: 117:
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Regarding instant claim 12, App ‘225 claims this conjugate formula in claim 12.
Regarding instant claim 15, App ‘225 claims an oligopeptide cleavable linker (claim 15).
Regarding instant claims 16, 19, and 20, App ‘225 claims a Ser-(d)Ala-Pro FAPα enzyme cleavable linker (claims 14 and 19).
Regarding instant claims 28, 31, and 34, App ‘225 claims cytotoxic drug moieties (claim 22), as well as talabostat as a drug moiety (claims 32 and 33).
Regarding claim 53, App ‘225 claims pharmaceutical compositions comprising the therapeutic conjugate and an acceptable excipient (claim 52).
App ‘225 anticipates the instantly claimed invention. This is a provisional nonstatutory double patenting rejection.
The following Double Patenting rejections have been withdrawn:
Copending Application 18/018,208 has been amended to be out of scope of the instantly claimed invention. The Nonstatutory Double Patenting rejection for this application has been withdrawn.
Copending Applications 17/554,823 and 15/734,445 have been abandoned. The Nonstatutory Double Patenting rejections for these applications have been withdrawn.
Conclusion
No claim is allowed.
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 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.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
