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 Restriction Requirement remarks filed on June 13, 2025. Claim(s) 1, 2, 4-6, 11-17, 25, and 28-34 are pending. Claim(s) 33-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant's election of Group I drawn to a method of treating cancer and election of species of VS-6063 (FAK inhibitor), pimasertib (MEK inhibitor), and lung (cancer type) without traverse of the restriction requirement in the reply is acknowledged. The requirement is deemed proper and is therefore made FINAL. Claim(s) 1, 2, 4-6, 11-17, 25, and 28-32 are examined herein insofar as they read on the elected invention and species.
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, 2, 4-6, 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 in combination with a MEK inhibitor. 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 patented claims are embraced by the instant claims. Therefore, the two inventions overlap greatly in scope.
Claims 1, 2, 4-6, 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 in combination with a MEK inhibitor. 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 patented claims are embraced by the instant claims. Therefore, the two inventions overlap greatly in scope.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. The specification does not provide sufficient information that all cancers are treatable by a combination of MEK and FAK inhibitor as described in the methods claimed.
The determination that “undue experimentation” would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The breadth of the claims
There are hundreds of types of cancers and tumors which can occur in any part of the body. Thus, the claims are extremely broad.
The nature of the invention
The nature of the invention is the treatment of any cancer through the use of the claimed compounds. Currently, there are no known agents that treat these diseases all inclusively.
The level of predictability in the art
The treatment of these disorders is highly unpredictable. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The amount of direction provided by the inventor
The applicant has not demonstrated sufficient guidance provided in the form of administration profiles, combination ratios of the active agents or reference to the same in the prior art to provide a skilled artisan with sufficient guidance to practice the instant treatment of the disorders claimed. Further, the applicant discloses that an effective amount of the compound will be administered without providing any direction other than that the compound of the invention have a high therapeutic index and follows this with a definition readily found in a basic pharmacology textbook. It should be noted that the therapeutic index of a drug in humans is almost never known and is only determined through clinical experience.
The existence of working examples
There is not seen in the disclosure, sufficient evidence to support Applicant’s claims of treating these disorders. A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 27 USPQ2d 1510 (CAFC). The disclosure does not demonstrate sufficient evidence to support the applicant's claim to the treatment and methods in inhibition. There are not sufficient working examples or data from references of the prior art to provide a nexus between those examples and a method of treating these disorders with the claimed compounds.
The level of one of ordinary skill
The level of skill is that of one with a doctoral understanding of central nervous system disorders, which embraces the multitude of diseases recited above. Applicant’s data is not convincing as to make the production and use of pharmaceutical compositions comprising the recited compound feasible without undue, un-predictable experimentation.
The quantity of experimentation
A great deal of experimentation is required. In order for there to be a method of treating these disorders generally, as claimed by the applicant, it would be necessary to show that a vast range of different types of cancers as discussed above are treatable by said regimen. Furthermore, direction, in the form of examples, must be shown to determine what an effective dose may be. The references submitted do not demonstrate this. Therefore, one of ordinary skill in the art would require a significant amount of experimentation in order to determine the effective dosage to treat the multitudes of cancer types with the claimed compound individually or in combination with other therapeutic agents.
Genentech, 108 F.3d at 1366 states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable." Therefore, a method for treating cancer, generally, by administering a combination of MEK and FAK inhibitors of the claims is not considered to be enabled by the instant specification.
Claim Rejections - 35 USC § 112, first paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. The specification does not provide sufficient information that the combination of any and all FAK and MEK inhibitors are capable of treating cancer as described in the methods claimed.
The determination that “undue experimentation” would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The breadth of the claims
The breadth of the instant claims is seen to encompass methods for treating any cancer with a multitude of compounds as encompassed by FAK and MEK inhibitors. Thus, the claims are extremely broad.
The nature of the invention
The nature of the invention is treating any cancer through the use of a multitude of compounds as encompassed by FAK and MEK inhibitors. Currently, there are no known agents that treat all cancers inclusively.
The level of predictability in the art
The treatment of these disorders is highly unpredictable. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The amount of direction provided by the inventor
The applicant has not demonstrated sufficient guidance provided in the form of administration profiles, combination ratios of the active agents or reference to the same in the prior art to provide a skilled artisan with sufficient guidance to practice the instant treatment of the disorders claimed. Further, the Applicant discloses that an effective amount of FAK and MEK inhibitor will be administered without providing any direction other than that the compounds of the invention have a high therapeutic index and follows this with a definition readily found in a basic pharmacology textbook. It should be noted that the therapeutic index of a drug in humans is almost never known and is only determined through clinical experience.
The existence of working examples
There is not seen in the disclosure, sufficient evidence to support Applicant’s claims of treating these disorders. A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 27 USPQ2d 1510 (CAFC). The disclosure does not demonstrate sufficient evidence to support the Applicant's claim to the treatment and methods in treatment. There are not sufficient working examples or data from references of the prior art to provide a nexus between those examples and a method of treating these disorders with the combination composition.
The level of one of ordinary skill
The level of skill is that of one with a doctoral understanding of FAK and MEK inhibitors associated with cancer. Applicant’s data is not convincing as to make the production and use of pharmaceutical compositions comprising the recited compounds feasible without undue, unpredictable experimentation.
The quantity of experimentation
A great deal of experimentation is required. In order for there to be a method of treating cancer generally, as claimed by the applicant, it would be necessary to show that a vast range of FAK and MEK inhibitors. Furthermore, direction, in the form of examples, must be shown to determine what an effective dose may be. The references submitted do not demonstrate this. Therefore, one of ordinary skill in the art would require a significant amount of experimentation in order to determine the effective dosage to treat the multitudes of different types of disorders with the claimed compound individually or in combination with other therapeutic agents.
Genentech, 108 F.3d at 1366 states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable." Thus, it can be safely concluded that the instant case fails to provide an enabling disclosure for the treatment of treating any cancer with any combination of FAK and MEK inhibitor, which includes a multitude of disorders and compounds as discussed above.
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, 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.
Solca teaches a method of treating a mammalian, preferably human, patient diagnosed with cancer which is addicted to the MEK-signaling pathway or in which MEK is activated said method comprising administering an effective amount of a dual Aurora kinase / MEK inhibitor, optionally in combination with one or more other anti-cancer agents, to the patient (claim 5).
Solca teaches examples of other anti-cancer agents which may be administered in combination with the dual Aurora kinase / MEK inhibitor may include histone deacetylase inhibitors, proteasome inhibitors, HSP90 inhibitors, kinesin spindle protein inhibitors, cyclooxygenase inhibitors, bisphosphonates, biological response modifiers (e.g. cytokines such as IL-2, or interferons such as interferon-gamma), antisense oligonucleotides, Toll-like receptor agonists, deltoids or retinoids, Abl inhibitors or Bcr-Abl inhibitors, Src inhibitors, FAK inhibitors, among others (page 41, 1st full ¶).
Solca teaches the elements of the combinations may be administered (optionally independently) by methods customary to the skilled person, e.g. by oral, enterical, parenteral (e.g., intramuscular, intraperitoneal, intravenous, transdermal or subcutaneous injection, or implant), nasal, vaginal, rectal, or topical routes of administration and may be formulated, alone or together, in suitable dosage unit formulations containing conventional non-toxic pharmaceutically acceptable carriers, adjuvants and vehicles appropriate for each route of administration (page 55, 4th full ¶).
Solca teaches cancer is selected from pancreas cancer (PAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), ovarian cancer (OC), prostate cancer, breast cancer, hepatocellular cancer (HCC), melanoma, and thyroid cancer (claim 12).
Solca teaches the dosage for oral use is from 1-2000 mg per day (e.g. from 50 to 700 mg per day) (page 56, 2nd full ¶).
The difference between Solca and the claimed invention is that it does not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831,15 USPQ2d 1566 (Fed. Cir. 1990).
However, based on the above, Solca teaches the elements of the claimed invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Therefore, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited art.
Conclusion
Claims 1, 2, 4-6, 11-17, 25, and 28-32 are not allowed.
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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.
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/SAHAR JAVANMARD/Primary Examiner, Art Unit 1627
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