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 .
Status of the Application
This Office Action is in response to Applicant's arguments filed on February 27, 2026. Claim(s) 1, 2, 5-6, 11-17, 25, and 28-34 are pending. Claims 33-34 are withdrawn. Claim(s) 1, 2, 5-6, 11-17, 25, and 28-32 are examined herein insofar as they read on the elected invention and species.
Response to Arguments
In view of applicant’s amendment and arguments, the following rejections are hereby withdrawn:
Claims 1, 2, 4-6, 11-17, 25, and 28-32 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method of treating cancer wherein the cancer is mesothelioma, breast cancer, ovarian cancer, lung cancer, and non-hematolotic malignancies, does not reasonably provide enablement for the treatment of any cancer.
Claims 1, 2, 4-6, 11-17, 25, and 28-32 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a combination of VS-6063 (FAK inhibitor) and trametinib, GDC-0623, cobimetinib, AZD6244, and pimasertib (MEK inhibitors), does not reasonably provide enablement for the combination of any FAK and MEK inhibitor as instantly claimed.
Claims 1, 2, 4-6, 11-17, 25, and 28-32 are rejected under 35 U.S.C. 103 as being unpatentable over Solca (WO 2012/095505) of record.
Due to applicant’s decision to hold the nonstatutory obviousness-type double patenting rejections over claims 1, 2, 4-6, 11-17, 25, and 28-32 as being unpatentable over claims 1-16 of U.S. Patent No. 9,962,385 and over claims 1-11 of U.S. Patent No. 10,406,158 in abeyance, said rejections are hereby maintained.
Any rejection from the previous Office action not set forth on record below is hereby withdrawn.
The maintained/modified rejections are made in the Final Office action below as necessitated by amendment.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 1, 2, 5-6, 11-17, 25, and 28-32 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,962,385. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are to method of treating a subject having cancer, the method comprising administering to the subject a therapeutically effective amount of a FAK inhibitor, wherein the FAK inhibitor is VS-6063, in combination with a MEK inhibitor, wherein the MEK inhibitor is selected from the group consisting of trametinib, GDC-0623, cobimetinib, AZD6244, and pimasertib; wherein the cancer is selected from the group consisting of mesothelioma, triple negative breast cancer, ovarian clear cell carcinoma, lung cancer, and non-hematolotic malignancy. The patented claims teach a method of treating a subject having cancer the method comprising administering to the subject a therapeutically effective amount of VS-6063 or a pharmaceutically acceptable salt thereof, in combination with a MEK inhibitor, selected from the group consisting of GDC-0623, cobimetinib, trametinib, pimasertib, and AZD6244, thereby treating the subject, wherein the cancer is selected from a mesothelioma and breast cancer. The two inventions overlap greatly in scope.
Claims 1, 2, 5-6, 11-17, 25, and 28-32 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,406,158. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are to method of treating a subject having cancer, the method comprising administering to the subject a therapeutically effective amount of a FAK inhibitor, wherein the FAK inhibitor is VS-6063, in combination with a MEK inhibitor, wherein the MEK inhibitor is selected from the group consisting of trametinib, GDC-0623, cobimetinib, AZD6244, and pimasertib; wherein the cancer is selected from the group consisting of mesothelioma. triple negative breast cancer, ovarian clear cell carcinoma, lung cancer, and non-hematolotic malignancy. The patented claims teach a method of treating a subject having cancer the method comprising administering to the subject a therapeutically effective amount of VS-6063 or a pharmaceutically acceptable salt thereof, administered between 1 to 500 mg, in combination with a MEK inhibitor, selected from the group consisting of GDC-0623, cobimetinib, trametinib, pimasertib, and AZD6244, thereby treating the subject, wherein the cancer is selected from a mesothelioma and breast cancer. The two inventions overlap greatly in scope.
Conclusion
Claims 1, 2, 5-6, 11-17, 25, and 28-32 are not allowed.
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 extension fee 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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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s 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.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622
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