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 .
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.
Current Status of 18/878,118
This Office Action is responsive to the amended claims of 16 October 2025.
Claims 1-20 have been examined on the merits. Claims 1-4, 6-8, and 10-20 are original. Claims 5 and 9 are currently amended.
Priority
The instant application has the following effective filing date: 24 June 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6 July 2026; and 16 October 2025, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are 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.
Claim 12 is 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.
The various limitations: 1) within parentheticals AND 2) separated by colons (:) within claim 12 render the metes and bounds of claim 12 undefined (hence rendering claim 12 indefinite under 35 USC 112(b)). The artisan does not know whether the limitations within parentheticals and/or separated by colons are merely exemplary or are required limitations of the claim. Please remove all parentheticals and colons to render moot this rejection.
Conclusion
Claim 12 is not presently allowable as written.
Claims 1-11 and 13-20 are presently allowable as written.
There is no known prior art reference that either teaches or anticipates a compound of instant claim 1.
There is no anticipatory prior art against instant claim 1.
The closest reference MIRATI (U.S. 2021/0188857 A1) does not teach, suggest, or anticipate the free base form or the maleate salt form thereof of instant claim 1.
In fact, a review of MIRATI reveals that the artisan could not immediately envisage the free base form of the compound:
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within close art reference MIRATI.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D 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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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
