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 .
Election/Restrictions
Applicant’s election of Group I and species of one specific compound of conjugate with all variables completely specified (as shown on page 32 of specification as filed) in the reply filed on April 7, 2026 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)).
Specification
The disclosure is objected to because of the following informalities:
The use of the term AVANCE® which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
Claims 14-16 are objected to because of the following informalities:
Claims 14-16 fail to end with a period as required. Additionally, claims 14-16 lack a proper conjunction (“or”) before the final element of the species list.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10, 11, and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites “(e.g., gadolinium….” The phrase “e.g.” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Additionally, the use of parenthesis “(“ in the recitation adds confusion because it is unclear whether the limitations following the parenthesis are part of the claimed invention.
The dependent claims fall therewith.
Clarification and/or amendment is required.
Claim Rejections - 35 USC § 103
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 1-4 and 6-26 are rejected under 35 U.S.C. 103 as being unpatentable over Low et al. (WO 2021 055641; cited on PTO-892) in view of Bachovchin et al. (WO 2021 195198; cited on PTO-892).
Regarding claim 1, Low discloses a compound (conjugate) comprising a binding ligand such as a fibroblast activation protein (FAP) ligand or a radical thereof; a linker connecting two or more functional parts; and an imaging agent such as a compound or a radical thereof that emits a detectable signal such as an electromagnetic signal (¶ 82; ¶ 84; ¶ 85; ¶ 87). Regarding claims 2-4, Low discloses a compound of binding ligand
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(claim 4), which reads on the FL of instant claims and elected species. Regarding claims 6 and 7, Low discloses a linker
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when n is 3 (¶ 155), which reads on the L of instant claims and elected species. Regarding claim 26, Low discloses a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier (claim 36). Low discloses the compound comprising FL, L, and a fluorescent dye as an imaging agent (claim 35).
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Regarding claim 1, Low does not disclose that the imaging agent is a magnetic resonance imaging (MRI) agent. Regarding claims 8-25, Low does not disclose that the imaging agent is a paramagnetic contrast agent comprising a metal such as gadolinium (Gd3+) and a chelator such as DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid).
Bachovchin discloses FAP-targeted imaging agents which can be detected and quantitated by MRI (abstract; page 19, lines 12-13). Bachovchin discloses that FAP inhibitor moieties can be linked to a chelating agent comprising DOTA and a paramagnetic ion such as Gd3+ (claim 10; page 24, Table 1; page 28 line 6-page 29 line 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the compound of Low by substituting the fluorescent imaging agent with Gd-DOTA (gadoterate dotarem) for MRI analysis. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Bachovchin teaches that Gd-DOTA can be used as FAP-targeted MRI agent. Further, a person of ordinary skill in the art would have been motivated to use Gd-DOTA as a well-known MRI agent in order to achieve accurate deep-tissue imaging and expand the applications of the compound with the advantage or avoiding the use of radionuclides. Accordingly, applying the teachings of Bachovchin to the compound of Low to utilize Gd-DOTA constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders instant claims obvious.
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 1-4 and 6-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 17/761,508 (US 2022 0409747; cited on PTO-892) in view of Bachovchin et al. (WO 2021 195198; cited on PTO-892).
Regarding claims 1-4, claim 1 of the ‘508 recites a compound comprising a radical of FAP alpha ligand; linker; and a radical of an optical dye, a photodynamic therapeutic agent, a radio-imaging agent, a radiotherapeutic agent, a chemotherapeutic agent, an antifibrotic agent, or an anticancer agent. Claim 41 of the ‘508 recites a compound of FAP ligand
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, which reads on the FL of instant claims.
Regarding claims 6 and 7, claims 43 and 44 of the ‘508 recites the linker, which reads on the L of instant claims.
Regarding claim 26, claim 56 of the ‘508 recites a pharmaceutical composition.
Regarding claim 1 and 8-25, claims of the ‘508 do not recite that the imaging agent is a MRI agent such as a paramagnetic contrast agent comprising Gd3+ and DOTA.
As discussed above, Bachovchin discloses FAP-targeted imaging agents which can be detected and quantitated by MRI (abstract; page 19, lines 12-13). Bachovchin discloses that FAP inhibitor moieties can be linked to a chelating agent comprising DOTA and a paramagnetic ion such as Gd3+ (claim 10; page 24, Table 1; page 28 line 6-page 29 line 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the compound of the ‘508 by substituting the imaging agent with Gd-DOTA for MRI analysis. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Bachovchin teaches that Gd-DOTA can be used as FAP-targeted MRI agent. Further, a person of ordinary skill in the art would have been motivated to use Gd-DOTA as a well-known MRI agent in order to achieve accurate deep-tissue imaging and expand the applications of the compound. Accordingly, applying the teachings of Bachovchin to the compound of the ‘580 to utilize Gd-DOTA constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders instant claims obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4 and 6-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 17/995,806 (US 2023 0158153; cited on PTO-892) in view of Bachovchin et al. (WO 2021 195198; cited on PTO-892).
Regarding claims 1-4, 6, and 7, claim 1 of the ‘806 recites a compound comprising FAP ligand, linker, and a therapeutic agent. Claim 11 of the ‘806 recites a compound of FAP ligand
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, which reads on the FL of instant claims.
Regarding claim 26, claim 15 of the ‘806 recites a pharmaceutical composition.
Regarding claim 1 and 8-25, claims of the ‘806 do not recite that the MRI agent such as a paramagnetic contrast agent comprising Gd3+ and DOTA.
As discussed above, Bachovchin discloses FAP-targeted imaging agents which can be detected and quantitated by MRI (abstract; page 19, lines 12-13). Bachovchin discloses that FAP inhibitor moieties can be linked to a chelating agent comprising DOTA and a paramagnetic ion such as Gd3+ (claim 10; page 24, Table 1; page 28 line 6-page 29 line 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the compound of the ‘806 by substituting the therapeutic agent with Gd-DOTA for MRI analysis. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Bachovchin teaches that Gd-DOTA can be used as FAP-targeted MRI agent. Further, a person of ordinary skill in the art would have been motivated to use Gd-DOTA as a well-known MRI agent in order to achieve accurate deep-tissue imaging and expand the applications of the compound. Accordingly, applying the teachings of Bachovchin to the compound of the ‘806 to utilize Gd-DOTA constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders instant claims obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4 and 6-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/550,964 (US 2024 0238458; cited on PTO-892) in view of Bachovchin et al. (WO 2021 195198; cited on PTO-892).
Regarding claims 1-4, claim 1 of the ‘964 recites a compound comprising a radical of FAP alpha ligand; linker; and a radical of a therapeutic agent, a radio-imaging agent, a radiotherapeutic agent, a magnetic resonance imaging agent, a chemotherapeutic agent, an antifibrotic agent, or an anticancer agent. Claim 17 of the ‘964 recites that the compound can comprise a radical of chelating group bound to metal suitable for MRI. Claim 12 of the ‘964 recites a compound of FAP ligand
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, which reads on the FL of instant claims.
Regarding claims 6 and 7, claims 31 and 32 of the ‘964 recites the linker, which reads on the L of instant claims.
Regarding claims 9, 11, and 13-16, claims 18 and 19 of the ‘964 recites the chelating agents such as DOTA.
Regarding claim 26, claim 108 of the ‘964 recites a pharmaceutical composition.
Regarding claims 8, 10, 12, and 17-25, claims of the ‘964 do not recite a metal such as such as Gd3+ and a paramagnetic contrast agent such as Gd-DOTA.
As discussed above, Bachovchin discloses FAP-targeted imaging agents which can be detected and quantitated by MRI (abstract; page 19, lines 12-13). Bachovchin discloses that FAP inhibitor moieties can be linked to a chelating agent comprising DOTA and a paramagnetic ion such as Gd3+ (claim 10; page 24, Table 1; page 28 line 6-page 29 line 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize Gd-DOTA as a paramagnetic contrast agent for the compound of the ‘964 for MRI analysis. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Bachovchin teaches that Gd-DOTA can be used as FAP-targeted MRI agent. Further, a person of ordinary skill in the art would have been motivated to use Gd-DOTA as a well-known MRI agent in order to achieve accurate deep-tissue imaging and expand the applications of the compound. Accordingly, applying the teachings of Bachovchin to the compound of the ‘964 to utilize Gd-DOTA constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders instant claims obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
Prosecution Insights