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 .
Priority
The instant application, filed 10/26/2022, is a national stage entry of PCT/US2021/029435, filed 04/27/2021, which claims domestic priority to U.S. provisional application 63/015,883, filed 04/27/2020.
Preliminary Amendments and Claim Status
The preliminary amendment filed on 08/22/2025 is acknowledged and entered.
Claims 1, 2, 5-10, 12, 14, 15, 18, 24-16, 30-36, and 38-40 are cancelled;
Claims 3, 4, 11, 13, 16, 17, 19-23, 27-29, and 37 are pending and are under prosecution.
Information Disclosure Statement
The Information Disclosure Statement filed on 10/26/2022, 06/22/23, 10/17/2023, 09/12/2024, and 08/22/2025 are acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure statements are considered.
Restriction/Election
Applicant’s election without traverse of Group I in the reply filed on 08/22/2025 is acknowledged. Furthermore, the election of Species A: VS-6766 as the dual RAF/MEK inhibitor; Species B: defactinib as the FAK inhibitor; and Species C: non-small cell lung cancer as the type of cancer without traverse is also acknowledged.
In accordance with the MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species does not make a contribution over the prior art of record.
Status of Claims
Claims 3, 4, 11, 13, 16, 17, 19-23, 27-29, and 37 are pending in the instant application. Claim 4 is withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 3, 11, 13, 16-17, 19-23, 27-29, and 37 read on the elected invention and species and are therefore under consideration in the instant application.
Drawings
The drawings filed on 10/26/2022 are found to be in compliance with 37 CFR 1.121 § 1.84, and are hereby accepted.
Claim Interpretation
The instant claims are subject to the following claim interpretation:
A number of chemical names are used throughout the claim set. Because chemical compounds are known to have multiple names, it is necessary to identify the various names which commonly refer to the same chemical species. In terms of the instant application, the claim 11 recites “VS-6766” which is known within the chemical literature as Avutometinib or CH5126766 or VS-6766 or RO5126766, as evidenced by SelleckChem (Avutometinib). Furthermore, claim 28 and 29 recite “defactinib” which is known within the chemical literature as VS-6063, as evidenced by SelleckChem (Defactinib). Between the prior art and the instant application, these chemical names are hereby interpreted to be used interchangeably to refer to common chemical species.
Claim Rejections - 35 U.S.C. § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 3, 11, 13, 16, 17, 19-23, 27-29, and 37 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by NCT03875820 (Institute of Cancer Research. A Phase I Trial of Defactinib and VS-6766, publicly available March 15, 2019, cited on applicant IDS dated 06/22/2023). As multiple versions of the study disclosure are available, citations are made to version 1 of the clinical trial from March 2019, which includes the record history tab, study details, and researcher view sections of the clinical trial. This combined disclosure is included on the PTO-892 form and attached as non-patent literature to this office action.
The instant claims are drawn to a method of treating cancer, elected to be non-small cell lung cancer, having a KRAS G12V mutation, comprising administering to the subject an effective amount of a dual RAF/MEK inhibitor, elected to be VS-6766, and further comprising the administration of a FAK inhibitor, elected to be defactinib.
NCT03875820 teaches a method of treating patients with advanced solid tumors using the FAK inhibitor, VS-6063 also referred to as Defactinib (see instant claims 23, 27-29) and the dual RAF/MEK inhibitor RO5126776, also referred to as CH5126776 and VS-6766 (see instant claims 3 and 11) (page 2 of the disclosure). The patient population consisted of 20 patients with KRAS mutant non-small cell lung cancer (page 4 of the disclosure, see instant claims 3 and 37). Specifically, 10 patients with KRAS G12V mutant non-small cell lung cancer were included in the study (page 15, see instant claims 3 and 37). The clinical trial further teaches wherein the starting dose of VS-6766 is 3.2 mg twice a week (page 15 of the disclosure, see instant claims 13, 19, and 21). A cycle length for a duration of three weeks, and a single week when the drug is not administered is also taught (page 16 of the disclosure, see instant claims 16 and 17). It is taught that in KRAS Mutant non-small cell lung carcinoma patients, VS-6766 will be administered on a twice weekly schedule for 3 weeks followed by 1 week off in every 4 week cycle, wherein the starting dose will be 3.2 mg given orally as a single daily dose, and can be escalated to a maximum of 4 mg (pages 16 and 17 of the disclosure, see instant claims 13, 16, 17,19-22).
According to the teachings of the disclosure, the instant claims are wholly anticipated by NCT03875820, and all teaching are herein applied to the claims, individually. Thus, the claims stand rejected.
Correspondence
No claim is allowed.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623