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 18/266,793
This Office Action is responsive to the amended claims of 02/06/2024. Claims 1,20,25,27,30,38-40,43-44,46,49-52 and 54-58 are pending in this application and have been considered on the merits.
Priority
The instant application is a national stage entry of PCT/US2021/063724, international filing date 12/16/2021, which claims priority to U.S. Provisional Patent Application No. 63/126,364, filed 12/16/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/06/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
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, 20, 25, 27, 30, 39-40, 43-44, 46, and 49-52 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.
Base claim 1 recites substituents of R1-R4 that are “optionally substituted.” However the specification defines the term “substituted” as including “one or more substituents including, but not limited to” a non-exhaustive list of substituents and further states that substitution may occur at any valency-allowed position. These definitions render the scope of the claims open-ended and indeterminate with regard to the possible substituents and substitution patterns of R1-R4. Claims 20, 25, 27, 30, 39-40, 43-44, 46, and 49-52 do not remedy this issue.
Claim 1 defines (R1)m where m may be 0-5. Claim 25 recites “one R1 is halogen and the other R1 is optionally substituted C2-C6 alkynyl.” This language presumes the presence of exactly two R1 substituents, but claim 1 encompasses compounds having zero, one, or more than two R1 groups. It is unclear whether claim 25 requires exactly two substituents or how the limitation applies when fewer or more than two R1 groups are present. The scope of the claim in not reasonably certain. The Examiner recommends amending the claim to incorporate a limitation specifying the value of m to clarify the scope of the claim. For example, “wherein m=2, and one R1 is halogen and the other R1 is optionally substituted C2-C6 alkynyl” would clearly limit the claim to compounds of Formula (I) having exactly two R1 substituents and remove the ambiguity noted above.
Accordingly, the artisan would not be able to determine the metes and bounds of the claimed compounds with reasonable certainty, rendering the claims indefinite.
Close Art
Abel (WO 2006/045514, found in IDS filed 02/06/2024) discloses 3-arylamino pyridine compounds that are MAP kinase inhibitors useful in the treatment of hyperproliferative diseases (Abstract). The reference discloses 129 species of the claimed compound. Example 19 of the disclosure is the closest compound to the instantly claimed compounds and has the following structure
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. This compound corresponds to the instantly claimed compound of formula (I) when m is 2; one R1 is F, the other R1 is I; G1, G3, and G4 are CH; G2 is N, q is 3; and p is 0. Example 19 differs from the instantly claimed compounds in its connectivity of the piperidine ring at the nitrogen atom, compared to the same moiety of the instant compounds that connect at a carbon. While structure activity relationship studies, including modification of heterocycle attachment connectivity, are commonly employed in medicinal chemistry, the reference does not provide any teaching that would have led the artisan to select this particular compound from among the disclosed species as a starting point for modifications.
Allowable Subject Matter
Claim 38 is allowed. The prior art of record does not disclose or render obvious the compounds recited in claim 38.
Conclusion
1, 20, 25, 27, 30, 39-40, 43-44, 46, and 49-52 are rejected.
Claims 54-58 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the case claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR KENNEDY ENGLISH whose telephone number is (571)270-0813. The examiner can normally be reached Monday Friday, 8 a.m. 5 p.m. ET..
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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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/C.K.E./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625