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 preliminary amendment filed 7/7/2023, is acknowledged. Claims 1-10 are pending. Claim 10 is new.
Claim Rejections - 35 USC § 102
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5, 8 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pfannkuchen Nina: "Chelator-konjugierte Bisphosphonate: Synthese, Radiomarkierung
und in vivo-Evaluierung"(2018-0l-02), pages 1-198, XP055920286.
Phannkuchen discloses the compound BPDPSMA as a conjugate of a PSMA inhibitor, a bisphosphonate and a chelator, as well as its 68Ga-derivative which can be used as a theranostic against bone metastases of prostate carcinomas. See pages 119-148. Phannkuchen provides the structure for BPDPSMA as follows.
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Page 128.
Claim(s) 1-3, 5, 8 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kung et al. (WO2020/220032A1).
Kung et al. discloses two conjugates, each of which comprises a PSMA inhibitor, a bisphosphonate and a chelator, as well as their l 77Lu-derivatives, and proposes to use these compounds to treat metastatic prostate cancer in bones. See compounds 42 and 51 on page 65 and example 9 on pages 69-71.
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.
Claim(s) 4, 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pfannkuchen Nina: "Chelator-konjugierte Bisphosphonate: Synthese, Radiomarkierung und in vivo-Evaluierung"(2018-0l-02), pages 1-198, XP055920286 in view of Kung et al. (WO2020/220023A1).
Regarding claims 4, 6, and 7, the subject matter of claims 4, 6 and 7 would have been obvious over the combination of Phannkuchen and Kung et al. Each reference can be considered to be the closest prior art. The present claims 4, 6 and 7 define structural features
of the linkers for which it has not been demonstrated in the present application that its presence in the claimed compounds would lead to unexpected technical effects. This also applies in particular to the incorporation, according to claim 4, of a squaric acid group into the linker L2 bonded to the bisphosphonate.
It has been certainly demonstrated in the present application (see example 1 on
pages 24-25) that this measure can increase the affinity to bone tissue. However, in the present claims, the linker L2 is defined so broadly that the squaric acid group can be bonded to the bisphosphonate both directly and via up to twenty R3 groups; each individual R3 group in turn can have an arbitrary length. It is not plausible that an improved bond to bone tissue can be achieved across the full scope of this definition of the linker L2. Thus, the technical problem solved by the subject matter of claims 4, 6 and 7 is merely that of providing alternative conjugates of PSMA inhibitors, bisphosphonates and chelators for producing theranostics against bone metastases of prostate carcinomas.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the invention to in view of the cited reference to use squaric acid and imidazole groups as elements of linkers, as mentioned in claims 4 and 6, and the measure according to claim 7 of selecting a plurality of linkers to be identical.
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 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 17/786,844 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim obvious variants of a compound having the generic structure CT-.L1-Chel-X-TV. The differences being nominal because X, which is either S1 or L1, indicates a a spacer or linker which may be the same if not obvious entities.
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 ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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/ROBERT S CABRAL/ Primary Examiner, Art Unit 1614