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
Claims 1-29 are pending
Claims 1-29 are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/20/2024 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application claims benefit of U.S. Application No. 63/187,903 filed on 05/12/2021, U.S. Application No. 63/231,384 filed on 08/10/2021, U.S. Application No. 63/313,570 filed on 02/24/2022, and PCT Application No. PCT/US2022/028456 filed on 05/10/2022.
Claim Rejections - 35 USC § 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Flynn et al. (WO 2019/152711, as disclosed in IDS).
Flynn et al. teaches the use of l-[4-bromo-5-[l-ethyl-7-(methylamino)-2- oxo-l,2-dihydro-l,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea (ripretinib) in combination with a MAPKAP kinase inhibitor for the treatment of cancers, including c-KIT-mediated cancers, such as melanoma (see abstract; paragraphs 0009-0012). Flynn et al. teaches a typical daily dosage of ripretinib in a range of from about 5 mg per day to about 5000 mg per day, and particularly 150 mg per day, which can be divided into 1-4 doses (paragraph 000176). Flynn et al. teaches treatment of cancers resistant to imatinib, sunitib, or regorafenib (paragraphs 0007; 000115). Regarding claims 18-19 and 25-26, Flynn et al. teaches “The c-KIT mutation can be a primary mutation in exon 9, exon 11, exon 13, or exon 17 of the c-KIT gene… In some embodiments, the secondary resistance mutation is in exon 13, exon 14, exon 17, or exon 18 of the c-KIT gene.” (paragraphs 000114). Flynn et al. teaches “Eradication of an existing c-KIT-mediated tumor, e.g., a c-KIT-mediated GIST, is defined as a "complete cytocidal cell killing" of a tumor to the limit of detection as determined by 5X objective microscopy for in vitro evaluations, or as defined as a complete response as determined by RECIST 1.1” (paragraph 000107).
Therefore, the reference is deemed to anticipate the instant claims 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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Flynn et al. (WO 2019/152711, as disclosed in IDS) as applied to claims 1-26 above, and further in view of Pham et al. (KIT and Melanoma: Biological Insights and Clinical Implications, Yonsei Medical Journal, 2020, 61(7), pp. 265-571).
The teachings of Flynn et al. are presented above.
Flynn et al. does not teach wherein the melanoma is cutaneous or noncutaneous melanoma.
Pham et al. is drawn towards KIT mutations in melanoma (see abstract). Pham et al. teaches KIT mutations in a number of melanomas, including mucosal and desmoplastic melanomas (see Table 1).
It would have been obvious to one of ordinary skill in the art to treat melanomas wherein the melanoma is cutaneous or noncutaneous melanoma, as suggested by Pham et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since Flynn et al. teaches ripretinib effective in treating KIT mutations in melanoma (see abstract), which can be found in mucosal and desmoplastic melanomas as taught by Pham et al. (Table 1 ), with a reasonable expectation of success absent evidence of criticality of the particular steps.
Conclusion
Claims 1-29 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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