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 .
Current Status of 18/532,573
Claims 1, 4, 46, 48, 66, and 76-78 have undergone amendments. Claims 9, 10, 17, 45, 61-63, 65, 67-69, 75, and 84-93 have been cancelled. Thus, Claims 1, 4, 46, 48, 66, and 76-83, submitted on 1 June 2026, represent all claims currently under consideration.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
One Information Disclosure Statement (IDS), submitted on 1 June 2026, is acknowledged and has been considered.
Response to Arguments
The objection to Claim 4 is withdrawn. Applicant has amended both Claims 1 and 4 to remove reference to more than 1 R1 group.
The 35 U.S.C. § 12(b) rejection of Claims 9, 17, 61, 65, 75, and 89-93 are withdrawn. Applicant has cancelled Claims 9, 17, 61, 65, 75, and 89-93, rendering the rejections moot.
The 35 U.S.C. § 112(b) rejection of Claim 66 is withdrawn. Applicant has amended Claim 66 to include the missing “or” prior to compound I-cf.
The 35 U.S.C. § 112(d) rejection of Claim 66 is withdrawn. Applicant has cancelled the claim, rendering the rejection moot.
The 35 U.S.C. § 102(a)(1) rejection of Claims 1, 4, 9, 10, 45, and 76-83 over Yeh is withdrawn. Applicant has amended Claim 1 to require that the compounds have a monofluoro substitution on the cyclopropyl ring, and has removed the
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as a substituent for variable R3, and thus, the cited compound does not anticipate the amended claims.
The 35 U.S.C. § 103 rejections of Claim 75 over Moletni and Liu are each withdrawn. Applicant has cancelled Claim 75, rendering the rejections moot.
The 35 U.S.C. § 103 rejection of Claims 1, 4, 9, 10, 17, 45, 46, 48, 61-63, 65-69, and 75-93 over Yeh in view of Thornber is withdrawn. Applicant argues that there are at least 24 compounds disclosed by Yeh which are more potent than the most potent compound identified in the previous office action, none of which contain the cyclopropyl ring which is required in the compounds of the examined application, with each cited compound having a cyclobutyl ring or a cyclobutyl ring attached via a linker. Applicant further argues that 81 of the 111 compounds of Yeh which have IC50 values of less than 100 nM have cyclobutyl rings, while only 19 have cyclopropyl rings at the same position. Thus, one of ordinary skill in the art would be motivated to select a compound which has a cyclobutyl ring rather than cyclopropyl due to their lower IC50 values. Applicant further argues that none of the 24 most potent compounds comprise an R3 group as defined in the amended claims, with these compounds having heteroaryl or heterocyclic rings, methyl or methyl-d3, or no substitution at all present on the imidazo[1,2-a]pyridinyl ring system. Only 3 compounds disclosed by Yeh contain one of the claimed R3 groups, with only one of these compounds possessing an IC50 value of less than 100 nM. Thus, there is no teaching or suggestion within Yeh for the specific compounds as claimed, and there is no reasonable expectation that making these modifications would result in a compound that is a potent c-kit inhibitor. The Examiner finds these arguments to be persuasive.
The provisional non-statutory double patenting rejection over co-pending Application No. 19/136,334 is maintained. The co-pending application has the same effective filing date as the examined application, and the claims of the co-pending application read on the amended claims, as described in the previous Office Action. Applicant argues that the claims of the examined application and the ‘334 application are patentably distinct as subgenus and genus. The Examiner does not find this argument to be persuasive as the compounds of the examined application meet the limitations of what is claimed in ‘334, and ‘334 specifically claims compounds which are obvious variants of the compounds of the examined application (See NSDP Rejection, Below).
Double Patenting- REJECTIONS MAINTAINED
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, 46, 48, 66, and 76-83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7, 15, 17, 24, 30, 40, and 43-51 of copending Application No. 19/136,334 (Claims of 6 June 2025) (‘334) (reference application).
Claim 1 of ‘334 is directed to compounds of Formula (I)
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. Claim 4 of ‘334 is directed to compounds of Claim 1 wherein X is O. Claim 7 of ‘334 is directed to the compound of Claim 1 wherein R1 is C1-C6 alkyl. Claim 15 of ‘334 is directed to the compound of Claim 1 wherein the compound is of formula
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. Claim 17 of ‘334 is directed to a compound of formula
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. Claim 24 of ‘334 claims the compound of Claim 1 wherein Rb is selected from a group which includes
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. Claim 30 of ‘334 is directed to the compound of Claim 1 wherein at least one R2 is a 3-4 membered saturated monocyclic carbocycle. Claim 40 of ‘334 is directed to the compound of Claim 1 wherein R2 is selected from a group which includes
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. Claim 43 of ‘334 claims a compound of Table 1. Claim 44 of ‘334 claims a pharmaceutical composition comprising a compound of the invention and a pharmaceutically acceptable carrier. Claim 45 of ‘334 claims a method of inhibiting c-Kit activity using a compound of the invention. Claim 46 of ‘334 claims a method of treating a c-Kit kinase mediated disease comprising administering a compound of the invention. Claims 47, 48, 49, and 50 of ‘334 specify the diseases to be treated which encompasses those claimed in the examined application. Claim 51 of ‘334 claims the method of claims 46-50 wherein the patient is human. Compounds claimed in the invention include II-3 (Page 105 of specification)
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, as well as the compounds
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and
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which has a
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group rather than
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group; the artisan would not expect these compounds to have significantly different properties due to the close chemical structure (See MPEP § 2144.09 I). As such, these compounds are obvious variations of what is claimed in the examined application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 4, 46, 48, 66, and 76-83 are rejected.
THIS ACTION IS MADE FINAL. 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 PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.M.R./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
Prosecution Insights