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 .
According to a preliminary amendment filed on Nov. 6, 2023, the applicants have canceled claims 4 and 9-11 and furthermore, have amended claims 1-3 and 5-8.
Claims 1-3 and 5-8 are pending in the application.
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.
5. 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.
6. Claims 1-2, 6 and 8 are rejected under 35 U.S.C. 103 as being obvious over Lee (WO 2019/182274 A1).
Lee discloses Thienopyridine derivatives as inhibitors of RON kinase activity for treating various cancers including colorectal cancer (see page 2, lines 11-13). The compounds disclosed in examples 2-30 (see table 1on pages 50-57) and examples 32-37 (see table 2 on pages 63-65) by Lee anticipate the instant compounds of formula (1) and therefore, meet all the limitations of instant claims except that Ron-mutated cancer is colorectal cancer instead of instant cholangiocarcinoma (bile duct cancer). However, Lee does teach anticancer effect in RON-activated (KM 12C) and RON-mutated (HT29) colon cancer cells (see example 2 on page 67 and table 4 on page 68). Therefore, it would have been obvious to one skilled in the art to treat any RON-mutated cancer including cholangiocarcinoma with compounds disclosed by Lee with reasonable expectation of success.
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
7. Claims 1, 3, 6 and 8 are rejected under 35 U.S.C. 103 as being obvious over Ryu (WO 2021/025407 A1).
Ryu discloses oxo-pyridine fusion ring derivatives as inhibitors of RON-activated kinase activity for treating various cancers including colorectal cancer. The compounds disclosed in examples 40-53 (see paragraphs 937-990) and examples 77-178 (see paragraphs 1109-1513) by Ryu (see English translation of this document) anticipate the instant compounds of formula (2) when instant variable L represents NH and therefore, meet all the limitations of instant claims except that Ron-mutated cancer is colorectal cancer instead of instant cholangiocarcinoma (bile duct cancer). However, Ryu does teach anticancer effect in RON-activated (KM 12C) and RON-mutated (HT29) colon cancer cells (see figures 1-3)). Therefore, it would have been obvious to one skilled in the art to treat any RON-mutated cancer including cholangiocarcinoma with compounds disclosed by Ryu with reasonable expectation of success.
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Double Patenting
8. 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.
9. Claims 1, 2, 6 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10-15 of U.S. Patent No. 11,447,500. Although the claims at issue are not identical, they are not patentably distinct from each other because it would have been obvious to one skilled in the art to treat any RON-mutated cancer including cholangiocarcinoma with instant compounds of formula (1) disclosed by the cited patent with reasonable expectation of success since the cited patent does teach treating RON-mutated colon cancer with these compounds.
10. Claims 1-3 and 5-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-18 of copending Application No. 17/999,189 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because it would have been obvious to one skilled in the art to treat any RON-mutated cancer including cholangiocarcinoma with instant compounds of formulae 1 and 2 with reasonable expectation of success since the cited application does teach treating RON-mutated small-cell lung cancer with these compounds.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621