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 response and amendment filed 7/06/2026, are acknowledged. Claims 6, 8-13 and 15-25 are pending. Claims 22-25 are new.
Response to Amendment
The rejection of claims 6, 10, 12-14, 18 and 19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in light of the claim amendments.
Response to Arguments
Applicant’s remarks are well-taken but are not persuasive. Amending the claims to indicate claim that targeting agent is intended to act “as a discrete chelating unit” is immaterial. See Reply at pages 8-9. First, the recitation that an element is “capable of” performing a function is not a positive limitation, but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchinson, 69 USPQ 138. Second, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Third, since a chemical composition and its properties are inseparable, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As demonstrated in the rejection below, the amended claims including the combination of a targeting agent having the indicated structure and a coligand as a second chelator are taught and/or suggested by Bachovchin et al.
Applicant further argues that features such as “enhanced affinity” and “dual function” are not disclosed by Bachovchin et al., yet neither of these features are claimed. If Applicant can argue features such as mechanical attribution to hydrazine nitrogens or van der Waal interactions and hydrogen bonds, they can just as simply be recited in the claims. The same goes for indicating any bond between the targeting agent and coligand, which is absent from claims 6, 8-13 and 15-20 and new claims 22-24. To be sure, claim 25 does recite “covalently conjugated thereto,” however, these is still taught and/or suggested by Bachovchin et al. as demonstrated in the rejection below.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claim(s) 6, 8-13 and 15-25 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Bachovchin et al. (WO 2021/195198 A1).
Regarding claim 6, Bachovchin et al. teaches
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and
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.
Although the structure appears to be the same, absent evidence to the contrary, the nomenclature would imply a different placement of the N in the phenyl group, which arguably would be the same as in claim 5. Nonetheless, even if not implicit, the claimed compound would be obvious over the disclosure of these compounds. Further, Bachovchin et al. teaches that the compound is of the general formula IV, which may have a chelating agent:
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See claim 11 of Bachovchin et al. Further, the compound may be complexed with 99mTc. See claim 23 of Bachovchin et al.
Regarding claim 8, 9 and 25, “the chelating agent may comprise any chelator known in the art,” including DOTA. Page 24, line 1 and page 28 line 2. Further, absent evidence to the contrary, R-L indicates a covalent bond.
Regarding claim 10, Bachovchin et al. teaches pharmaceutically acceptable vehicles including nontoxic buffers. See page 42, lines 27-28.
Regarding claim 11, 12, 15 and 16, the wherein clauses introduce a product by process limitation. Where “[p]roduct-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps . . . [t]he patentability of a product does not depend on its methods of production.” MPEP 2113. Thus, absent evidence to the contrary, the composition as claimed in claims 11 and 12 are believed to be the same composition of claim 10. The determination of the patentability is based on the product itself and not the process recited in the claims. “If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 13, Bachovchin et al. teaches admixing a radioactive isotope reagent and a precursor of the compound with a chelating moiety. See page 38, line 25 – page 29, line 8.
Regarding claim 17, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since chemical composition and its properties are inseparable, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claims 18-20, Bachovhin et al. teaches that the invention “is intended for the use in the diagnosis or treatment of a disease characterized by overexpression of fibroblast activation protein.” Page 7, lines 9-11. This includes “treating a subject suffering from a tumor or cancer . . . which may comprise administering to a subject in need thereof an effective amount of one or more compounds.” Page 7, lines 18-20.
Regarding claims 21 and 22, the claimed formula would have been readily envisaged, if not obvious, from the teachings of Bachovchin et al.
Regarding claims 23 and 24, Bachovchin et al. teaches that “FAP-targeted agents can be detected (and quantitated) by . . . positron emission comprising a metal tomography (PET).” Page 19, lines 12-14.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT S CABRAL/Primary Examiner, Art Unit 1614
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