FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed Apr. 29, 2026.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The rejections and/or objections set forth below are either maintained or newly applied, and constitute the complete set presently applied to the instant claims.
STATUS OF THE CLAIMS
Claims 5, 6, 9-11, 15-17, 19-23, 26, 27, and 33 have been canceled.
Claims 1-4, 7, 8, 12-14, and 18 have been amended and incorporate no new matter.
Claims 24, 25, 31, 32, and 34 stand withdrawn as drawn to nonelected inventions.
No new claims have been added.
Thus, claims 1-4, 7, 8, 12-14, 18, and 28-30 now represent all claims currently pending and under consideration.
INFORMATION DISCLOSURE STATEMENT
The information disclosure statements (IDS) submitted on Mar. 5, 2026 and Jun. 17, 20206 were filed after the mailing date of the non-final action on Feb. 6, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
MAINTAINED REJECTIONS
The following rejection is maintained from the previous Office Action dated Feb. 6, 2026, on the ground that the references cited therein continue to read on the limitations of the amended claims.
Double Patenting
Claims 1-4, 7, 8, 12-14, 18, and 28-30 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-14, and 18-24 of copending Application No. 19/101,315 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would be anticipated by the reference claims.
Specifically, the reference claims are drawn to crystal forms and salts of the compound of formula (I), having the structural formula,
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which is identical to the elected compound species (I-3) encompassed by examined claims 1-4, 7, 8, 12-14, and 28-30, and as recited by examined claim 18.
The reference claims are also drawn to
methods of making and using the elected compound species; and
compositions comprising the elected compound species, an additional active agent
(e.g., trametinib), and a pharmaceutically acceptable carrier.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
RESPONSE TO ARGUMENTS
Applicant’s arguments, see Remarks pp. 18-22, filed Apr. 29, 2026, with respect to the rejection under 35 U.S.C. § 103 over Ramharter et al. (WO 2019/122129) in view of Colby et al. (2017), and Cregg et al. (US Pub. 2023/0096028) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
With regard to the nonstatutory double patenting rejection over claims 1-4, 6-14, and 18-24 of copending Application No. 19/101,315, Applicant will respond properly after the above patentability issue/rejections are resolved (Remarks, p. 22).
Because Applicant has not filed a terminal disclaimer or presented any arguments against it, the double patenting rejection is maintained.
Applicant requests reconsideration and withdrawal of the restriction requirement even though the requirement was made final in the Office action dated Feb. 6, 2026 (Remarks, p. 16).
As recognized by MPEP § 821.04, the propriety of a restriction requirement should be reconsidered when all the claims directed to the elected invention are in condition for allowance, and the nonelected invention(s) should be considered for rejoinder. In order to be eligible for rejoinder, a claim to a nonelected invention must depend from or otherwise require all the limitations of an allowable claim.
Here, withdrawn claims 24, 25, 31, 32, and 34 depend, directly or indirectly, from claim 1, which remains rejected and thus is not in condition for allowance. Therefore, rejoinder of withdrawn claims drawn to nonelected invention(s) would be improper at this time.
Upon the indication of allowability of the elected claims, the withdrawn method claims that depend from or otherwise require all the limitations of an allowable claim will be considered for rejoinder and full examination on the merits.
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure:
US Pub. 2025/0325572 and WO 2022/166592 (both cited on PTO-892).
CONCLUSION
No claims are allowed.
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.
CORRESPONDENCE
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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