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
This action is responsive to the amended claims of 12/17/2025. Claims 1-2, 8-9, 11-12, 14-15, 17-22, and 39 are pending. Claims 1-2, 8-9, 11-12, 14-15, 17-22, and 39 have been examined on the merits.
Election/Restrictions
The amendments of 12/17/2025 have overcome the rejections of the previous action, mailed 09/18/2025. Thus, the Markush search has been extended. The search was extended to the full scope of Formula (I) as defined in claim 1. The search did not return any prior art (see SEARCH 6 of the attached search notes). Thus, the election requirement of 04/30/2025 has been rendered moot and is withdrawn.
Priority
The effective filing date is 02/24/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/17/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Examiner acknowledges receipt of and has reviewed the amendments and remarks of 12/17/2025; no new matter is found.
The objection to the specification was not addressed in Applicant’s response, thus, the objection is maintained below.
The objection to claims 1-2 is withdrawn since Applicant has added appropriate punctuation.
The 112(b) rejection of claims 1-2 regarding Z1-Z4 is withdrawn since Applicant has amended to clarify the moieties from which these variables are chosen.
The 112(b) rejection of claim 1-2 regarding R8 is withdrawn since Applicant has clarified the claimed moieties by addition of punctuation, as suggested.
The 102 rejection of claims 1-2 as anticipated by INUKAI is withdrawn since Applicant has amended independent claim 1 to recite wherein X1 is N – no longer C. INUKAI only teaches compounds wherein X1 is C. Thus, INUKAI does not teach or suggest any compound of the instant claims.
Specification - Maintained
The disclosure is objected to because of the following informalities: the compound structures recited in Tables 1A and 1B are of low resolution, the bonds and atoms are faint and pixelated making them difficult to read. To improve readability, please provide higher resolution structures for these two Tables.
Appropriate correction is required.
Response to Amendment
Specification – New Objections
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: Naphthyridine inhibitors of c-Met, Axl, Mer, and/or KDR.
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
In the instant case, the abstract lacks a description of the general nature of the compounds (e.g., class of naphthyridine). Please add this information to the abstract.
Claim Rejections - 35 USC § 112 – Necessitated by Amendment
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 8-9, 11-12, 14-15, 17-22, and 39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the variable R11 and the moieties from which R11 is chosen on Pg. 4. There is insufficient antecedent basis for this limitation in the claim. Due to Applicant’s amendments X1 is no longer chosen from CR11. The recitation of R11 on Pg. 4 now lacks antecedent basis since Formula (I) no longer contains a variable R11. Therefore, the metes and bounds of the claim are undefined rendering the claim indefinite. Dependent claims 2, 8-9, 11-12, 14-15, 17-22, and 39 are similarly rejected since they do not rectify the underlying issue.
To overcome: please strike the variable R11 from the claims. Since R11 is chosen from moieties containing further sub-variables (e.g., Re), please confirm that the sub-variables are utilized within the definitions of other variables that are present in Formula (I).
Conclusion
Claims 1-2, 8-9, 11-12, 14-15, 17-22, and 39 are rejected.
Note: a search for the claimed compound of Formula (I) did not retrieve any prior art (see SEARCH 6 of the attached search notes). The closest art is represented by: INUKAI (WO 2015/012298; previously provided by Examiner) and GONG (CN104072480; provided in IDS of 08/16/2022).
INUKAI teaches compounds which are Axl inhibitors (Pg. 108 last ¶ translation) Example 5 (27): N-{5-[(6,7-dimethoxy-4-quinolinyl)oxy]-2-pyridinyl}-2,5-dioxo-1-(3-pyridinyl)-1,2,5,6,7,8-hexahydro-3-quinolinecarboxamide (Pg. 56 ¶168; Pg. 50 translation), reproduced below:
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654
1177
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wherein B is 6-membered heteroaryl with 1 N heteroatom, n is 0, Z1 is N, Z5 is C(=O), Z2 is CR5 wherein R5 is H, Z4 is CR10 and Z3 is CR6 wherein R10 and R6 together form a fused 6-membered cycloalkyl wherein 1 ring C atom is replaced with carbonyl, R9 is H, X6 is N, X2 is CH, m is 0, X3 is CH, X1 is CH, X4 is CR1 and X5 is CR2 wherein R1 and R2 are each ORa wherein Ra is C1 alkyl. However, the instant X1 cannot be CH. INUKAI does not teach any compounds wherein X1 is N. Thus, INUKAI cannot teach or suggest the instant compounds.
GONG teaches compounds which inhibit c-Met (Pg. 43 ¶61 Table) such as compound 64 (Pg. 37 Table), reproduced here for clarity:
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257
723
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. Similar to INUKAI, above, the corresponding X1 is CH. However, the instant X1 cannot be CH. GONG does not teach any compounds wherein X1 is N. Thus, GONG cannot teach or suggest the instant compounds. Further, the combination of INUKAI and GONG does not suggest the instant compounds since neither teach X1 is N and, further, INUKAI and GONG are directed to differing objectives: preparing inhibitors of Axl vs. c-Met.
Note: co-pending Application No. 18/277,956 and U.S. Patent No. 12,371,428 were briefly considered for double patenting; however, both were found to differ in scope and not overlap in recited compound species. The species recited in Application No. 18/277,956 have 1 substantial structural difference from the instant compounds: the ring B is chosen from cycles not including aromatic rings. The species recited in U.S. Patent No. 12,371,428 have 1 substantial structural difference from the instant compounds: the ring B is chosen from carbocyclic aromatic rings not including heteroaromatic rings. Further the claims of both the Application ‘956 and U.S. Patent ‘428 each recite hundreds of species; thus, the artisan would have to engage in picking and choosing led by hindsight reasoning to even identify a lead compound to modify in order to arrive at the instant compounds.
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.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625