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 .
DETAILED ACTION
Claims 40-59 are pending in the instant application.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement filed on April 24, 2025. The submission is in compliance with the provisions of
37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 40, 49 and 58 are objected to because of the following informalities:
in claim 40, the phrase “optionally, R1 and R2 join” should be changed to “or R1 and R2 join” because the subject matter which follows is an alternative definition of variables R1 and R2 (line 6 of the claim);
in claim 49, the phrase “optionally, R1 and R2 join” should be changed to “or R1 and R2 join” because the subject matter which follows is an alternative definition of variables R1 and R2 (line 6 of the claim); and
in claim 58, the phrase “optionally, R1 and R2 join” should be changed to “or R1 and R2 join” because the subject matter which follows is an alternative definition of variables R1 and R2 (line 6 of the claim).
Appropriate correction is required.
Double Patenting
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 40-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,780,862 and over claims 1-16 of U.S. Patent No. 12,122,800. The instant claimed invention is directed to a method of inhibiting a MEK kinase enzyme and a method of treating cancer or neoplastic disease comprising contacting or administering a compound of Formula (I). U.S. Patent No. 11,780,862 claims compounds of the same Formula (I) and pharmaceutical compositions comprising compounds of the same Formula (I). U.S. Patent No. 12,122,800 claim specie which are embraced by instant Formula (I) and which specie in U.S. Patent No. 12,122,800 are found in the instant claims. See, for example, the third compound claimed in claim 1 of U.S. Patent No. 12,122,800, which is the same as the first compound in instant claim 48.
The instant application is a continuation of Application No. 18/335,803, now U.S. Patent 12,122,800,
which is a continuation of Application No. 18/175,074, now U.S. Patent 11,780,862. Although the claims in both U.S. Patent 11,780,862 and U.S. Patent 12,122,800 are directed to compounds and pharmaceutical compositions, no restriction was required during the prosecution of either of the U.S. Patents. Note Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 68 USPQ2d 1865 (CAFC 2003) which states at 1875: “a claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use”. Note also In re Sebek, 146 USPQ 44 (C.C.P.A. 1965). Therefore, the claims in U.S. Patent 11,780,862 and U.S. Patent 12,122,800 anticipate and/or render obvious the instant claimed invention.
Reminder to Applicant
As a reminder, Applicant should specifically point out the support in the original disclosure {i.e., page number(s) and line number(s)} for any new claims or amended claims and for any amendments made to the disclosure. Making generic statements such as “all amendments are fully supported in the originally filed disclosure or the originally filed claims” without specifying page numbers and originally filed claim numbers are insufficient. See MPEP §714.02 and MPEP §2163.06(I).
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Laura L. Stockton
(571) 272-0710.
The examiner can normally be reached on Monday-Friday from 8:30 am to 6 pm, Eastern Standard Time.
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 acting supervisor,
James Alstrum-Acevedo can be reached on 571/272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAURA L STOCKTON/ Primary Examiner, Art Unit 1626 Work Group 1620
Technology Center 1600
July 14, 2026
Book XXVII, page 130
Prosecution Insights