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 April 1, 2026. Claim(s) 1, 7-8, 10-11, and 21-32 are pending. Claim(s) 7, 10, and 21-28 are withdrawn. Claim(s) 1, 8, 11, and 29-32 are examined on the merits herein.
Response to Arguments
In view of applicant’s amendments, the following rejections are hereby withdrawn:
Claims 1, 5, 6, 8, 9, 11, 29, and 30-32 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for the treatment of mesothelioma, neurofibromatosis, renal cancer, lung cancer, non-small cell lung cancer, liver cancer, thyroid cancer, ovarian, breast cancer, schwannoma, meningioma, schwannomatosis, neuroma acoustic, adenoid cystic carcinoma, ependymoma comprising administering FAK inhibitors VS-4718 or VS-6063 in combination with an anti-4-1BB antibody, does not reasonably provide enablement for the treatment of all cancers with the combination of any immunotherapeutic agent and any immunotherapeutic agent or procedure.
Claim 1, 5, 6, 29, and 32 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 pre-AIA the applicant regards as the invention.
Claims 1, 5, 6, 8, 9, 11, 29, and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Garmey (US 2014/0105891) and Moskalenko (US 2004/0197312).
Applicant has decided to hold the following rejections in abeyance. Therefore, said rejections are hereby maintained.
Claims 1, 5, 6, 8, 9, 11, 29, and 30-32 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10,532,056.
Claims 1, 5, 6, 8, 9, 11, 29, and 30-32 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,564,927.
Any rejection from the previous Office action not set forth on record below is hereby withdrawn.
The new and 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).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 8, 11, and 29-32 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10,532,056. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are to a method for treating a human subject suffering from cancer, comprising administering a FAK inhibitor in combination with an immunotherapeutic agent or procedure, including an anti-PD antibody. Specific FAK inhibitors including VS-4718 and VS-6063 and cancers including renal cancer, lung cancer, non-small cell lung cancer, liver cancer, thyroid cancer, breast cancer, melanoma, pancreatic adenocarcinoma. and colorectal cancer. The patented claims teach treating a human subject suffering from cancer comprising administering to the subject an effective amount of VS-6063 or a pharmaceutically acceptable salt thereof, in combination with an anti-PD-1 antibody, wherein the cancer is selected from the group consisting of mesothelioma, lung cancer, non-small cell lung cancer, ovarian cancer, colorectal cancer, and pancreatic cancer. The two inventions overlap greatly in scope.
Claims 1, 8, 11, and 29-32 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,564,927. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims are to a method for treating a human subject suffering from cancer, comprising administering a FAK inhibitor in combination with an immunotherapeutic agent or procedure, including an anti-PD antibody. Specific FAK inhibitors including VS-4718 and VS-6063 and cancers including renal cancer, lung cancer, non-small cell lung cancer, liver cancer, thyroid cancer, breast cancer, melanoma, pancreatic adenocarcinoma and colorectal cancer. The patented claims are drawn to a method for treating a human subject suffering from cancer, comprising administering an effective amount of a FAK inhibitor selected from VS-6063 and VS-4718, or a pharmaceutically acceptable salt thereof, in combination with an anti-PD-1 antibody, wherein the cancer is selected from the group consisting of mesothelioma, neurofibromatosis, renal cancer, lung cancer, non-small cell lung cancer, liver cancer, thyroid cancer, ovarian cancer, breast cancer, schwannoma, meningioma, schwannomatosis, acoustic neuroma, adenoid cystic carcinoma, ependymoma, and ependymal tumors. The two inventions overlap greatly in scope.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 8, 11, and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Vidal (Molecular Targets and Cancer Therapeutics, 2013) of record (IDS 8/29/24; NPL No. C9) and Moskalenko (US 2004/0197312).
Vidal teaches amplification and overexpression of FAK have been observed in aggressive human cancers including ovarian and breast cancers.
Vidal teaches defactinib is (VS-6063) a potent, selective, and orally active FAK inhibitor.
Vidal discloses they have demonstrated that defactinib can be combined with paclitaxel and have observed preliminary signs of clinical activity.
Vidal teaches FAK inhibitors preferentially target breast and ovarian cancer stem cells (CSCs) relative to bulk tumor cells as evidenced by a diminished proportion of CSCs in multiple orthogonal CSC assays.
Vidal does not teach the defactinib with an antibody, namely anti-4-1BB as required by the limitations of the instant claims.
Moskalenko teaches improved methods of cancer immunotherapy, comprising: administering the combination of a cytokine-expressing cellular vaccine and at least one additional cancer therapeutic agent selected from the group consisting of an anti-CTLA4 antibody, an anti-4-1BB antibody (claims 1 and 13) wherein the cancer is cancer of the bladder, breast, colon, kidney, liver, lung, ovary, cervix, pancreas, rectum, prostate, stomach, epidermis; a hematopoietic tumor of lymphoid or myeloid lineage; a tumor of mesenchymal origin such as a fibrosarcoma or rhabdomyosarcoma; other tumor types such as melanoma, teratocarcinoma, neuroblastoma, glioma, adenocarcinoma and non-small lung cell carcinoma [0054].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed defactinib and paclitaxel in anti-proliferative treatments for breast cancer as taught by Vidal and employed a co-stimulatory antibody such as anti-4-1BB. As taught by Moskalenko, cancer therapeutic treatments may be improved with the use of anti-4-1BB antibodies in the treatment of breast cancer. The examiner respectfully points out the following from MPEP 2144.06: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose ....[T]he idea of combining them flows logically from their having been individually taught in the prior art.', In re Kerkhoven, 626 F.2d 846, 850,205 USPQ 1069, 1072 (CCPA 1980).
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Claims 1, 8, and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Schlaepfer (WO 2011/019943) of record and Moskalenko (US 2004/0197312).
Schlaepfer teaches a method of promoting apoptosis in tumor cells, which can result in inhibiting tumor growth, or inhibiting tumor metastasis, or promoting tumor apoptosis, or any combination thereof, by administration of an effective amount of a focal adhesion kinase (FAK) inhibitor, wherein the FAK inhibitor PND-1186 (aka VS-4718) has been found to inhibit tumor cells in murine models for breast and ovarian cancer (abstract; claim 1; claim 4).
Schlaepfer teaches the inhibitor can be administered orally to the patient (page 9, lines 2-5).
Schlaepfer teaches further administering an effective amount of a second medicament (claim 9).
Schlaepfer does not teach the second medicament as an antibody, namely anti-4-1BB as required by the limitations of the instant claims.
Moskalenko teaches improved methods of cancer immunotherapy, comprising: administering the combination of a cytokine-expressing cellular vaccine and at least one additional cancer therapeutic agent selected from the group consisting of an anti-CTLA4 antibody, an anti-4-1BB antibody (claims 1 and 13) wherein the cancer is cancer of the bladder, breast, colon, kidney, liver, lung, ovary, cervix, pancreas, rectum, prostate, stomach, epidermis; a hematopoietic tumor of lymphoid or myeloid lineage; a tumor of mesenchymal origin such as a fibrosarcoma or rhabdomyosarcoma; other tumor types such as melanoma, teratocarcinoma, neuroblastoma, glioma, adenocarcinoma and non-small lung cell carcinoma [0054].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed VS-4718 in anti-proliferative treatments for breast cancer further comprising a second agent as taught by Schlaepfer and employed a co-stimulatory antibody such as anti-4-1BB. As taught by Moskalenko, cancer therapeutic treatments may be improved with the use of anti-4-1BB antibodies in the treatment of breast cancer. The examiner respectfully points out the following from MPEP 2144.06: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose ....[T]he idea of combining them flows logically from their having been individually taught in the prior art.', In re Kerkhoven, 626 F.2d 846, 850,205 USPQ 1069, 1072 (CCPA 1980).
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Conclusion
Claims 1, 8, 11, and 29-32 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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