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 .
Priority
This application is a 371 of PCT/KR2022/007115 (05/18/2022)
and claims foreign priority to KOREA, REPUBLIC OF 10-2021-0064278 (05/18/2021)
and KOREA, REPUBLIC OF 10-2022-0060706 (05/18/2022).
Claim Rejections - 35 USC § 102
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)(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.
(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.
Claims 1, 2, 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jin et al. (WO2017007241, citations to machine translation).
Jin teaches treating colorectal cancer patients with a simultaneous inhibitor of PARP and tankyrase, specifically compound B which is the same as in instant claim 1 ([46]: “Compound B is 6-{4-[(5-oxo -1,2,3,4,5,6-hexahydrobenzo [h] [1,6 ] naphthyridin-8-yl)methyl ] piperazin-1-yl } nicotinonitrile”; [58]: “The present invention can maximize the effect of treating colorectal cancer by classifying patients having susceptibility to simultaneous inhibitor against PARP and tankyrase”). Jin teaches in vivo mouse experimental results where compound B reduced tumor size in a resistant tumor compared to olaparib ([207]-[[217] Examples 21-22; [239]-[243] Example 26, Fig. 20; [240]: “colorectal cancer patient-derived cells 11-CT-79558D (p53 WT LIG4 MT), 11-CT -80464B (p53 WT LIG4 MT) and 11CT-94575 (p53 WT LIG4 WT), 13 CT -78649B (p53 WT LIG4 WT)”).
Regarding claim 1, Jin teaches the same compound administered to an effective amount to a patient (mouse) where the tumor is PARP inhibitor resistant (no change in tumor with olaparib).
Regarding claim 2, the LIG4 mutant tumor cells are HRD.
Regarding claim 6, the tumor cells do not have a BRCA mutation.
Regarding claims 7-8, the mutant tumor cells are olaparib resistant.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Jin et al. (WO2017007241, citations to machine translation) in view of Lee et al. (US20180162834) and Cook et al. (BioDrugs (2019) 33:255–273).
Jin teaches as in the 35 USC 102 rejection of claims 1, 2, 6-8 above and also renders these claims obvious.
Regarding claim 3, Jin does not teach the cancer has BRCA 1/2 mutation.
Lee claims compound 89 (the same as Jin’s Compound B) (claim 10: “89) 6-{4-[(5-oxo-1,2,3,4,5,6-hexahydrobenzo[h][1,6]naphthyridin-8-yl)methyl]piperazin-1-yl}nicotinonitrile”) useful in treating cancers including tumors of ovarian cancer which has BRCA-1 and -2 mutation and PARP resistant cancer (claim 18: “treating diseases caused by PARP-1, tankyrase-1 or tankyrase-2 activity”; [0003]: “PARP inhibitors were reported to be useful for specific killing of tumors deficient in DNA double-strand repair factors such as BRCA-1 and BRCA-2, and thus have been developed as patient-specific anticancer agents against various types of cancers, including breast cancer, ovarian cancer”, “PARP can contribute to resistance that may occur in various types in cancer therapy”; claim 15;).
Cook teaches successful treatment with PARP inhibitors in patients with BRCA germline and somatic mutations (p. 255: “women with BRCA1/2 mutations (either germline or somatic), maintenance PARP inhibitor therapy for those with recurrence has led to a nearly fourfold prolongation of progression-free survival”).
One of ordinary skill in the art following the teaching of Jin would have considered Lee’s teaching of treating cancer including BRCA mutations with the same compound and further in view of Cook’s teaching of success with PARP inhibitors with respect to BRCA mutation status. One of ordinary skill in the art would have had a reasonable expectation of success in the combination because the prior art are in the same field of endeavor of cancer therapy using PARP inhibitors. Given the mechanism described in the prior art of PARP inhibition, one of ordinary skill in the art would have considered utilizing the same class of inhibitor in treating the same cancer and arrive at the claimed invention with a reasonable expectation of success.
Regarding claims 4-5, Cook teaches successful treatment with PARP inhibitors in patients with BRCA germline and somatic mutations (p. 255: “women with BRCA1/2 mutations (either germline or somatic), maintenance PARP inhibitor therapy for those with recurrence has led to a nearly fourfold prolongation of progression-free survival”).
Regarding claim 6, Cook teaches successful treatment with PARP inhibitors without BRCA mutations (p. 255: “Those without BRCA1/2 mutations experience an approximately twofold increase in progression-free survival.”).
Regarding claim 9-10, Lee and Cook both teach PARP inhibition for treating ovarian cancer.
Regarding claim 11, Cook teaches PARP inhibition in treating metastatic ovarian cancer (p. 269: clinical trial in “Metastatic or recurrent endometrial or ovarian carcinosarcoma post first-line chemotherapy”).
Regarding claim 12, Lee teaches pharmaceutically acceptable salts of the compound, including citrate salt ([0228]; claim 1, Formula 1) which one of ordinary skill in the art would consider a routine substitution of a known equivalent and arrive at the claimed invention with a reasonable expectation of success.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
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 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 9 of U.S. Patent No. 10464919 (sharing the same disclosure as Lee et al. (US20180162834)) in view of Jin et al. (WO2017007241, citations to machine translation) and Cook et al. (BioDrugs (2019) 33:255–273). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims the same compound and as detailed in the 35 USC 103 rejection supra would render the instant claims obvious.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24-33 of copending Application No. 18561962 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims the same compound with a disclosed utility of treating cancers in the same manner as in the instant claims. Thus, one of skill in the art construing the scope of the claims would consider the same utility thereby rendering the instant claims obvious
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626