Detailed Action
The present office action is in response to the remarks filed on 28 Oct 2025.
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
Claims 22-23 of the pending application have been examined on the merits. Claim 24 is withdrawn (see “Response to Applicant Election” below). Acknowledgement is made of the amendments filed 18 Jul 2024. Acknowledgement is made of the cancellation of claims 1-21.
Priority
Applicants identify the instant application, Serial #: 17/835,261, filed 08 Jun 2022, as a Continuation of International Patent Application #: PCT/EP2020/084969, filed 08 Dec 2020, which claims foreign priority from Foreign Application #: EP19214867.4, filed 10 Dec 2019.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 14 Sep 2022 and 22 Jul 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Election
Applicant’s election without traverse of Group I, claims 22-23, in the reply filed on 28 Oct 2025 is acknowledged. Prior art was found during a search for Group I.
Claim 24 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 28 Oct 2025.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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.
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2012/118492 (provided in IDS 09/14/22), hereinafter '492, further in view of Wenglowsky et al. (Bioorg Med Chem Lett, 2014, 24:1923-1927; provided in IDS 09/14/22), hereinafter Wenglowsky, and Liu et al. (Bioorg Med Chem, 2016, 24:2215-2234), hereinafter Liu.
The instant claims are directed to the following compound (claim 22) and compositions of the compound with a therapeutically inert carrier (claim 23):
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'492 teaches compounds of reference Formula IV (paragraph [0053]; Claim 6):
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Formula IV is the genus of the species claims of the instant compound when R1 is hydrogen (paragraph [0099]); R2 is CN (paragraph [0099]); R3 is hydrogen (paragraph [0099]); R4 is NRaRb (paragraph [00119]); Ra and Rb are C1-C5 alkyl (paragraph [00119]); R5 is H (paragraph [00122]); R6 is methyl (paragraph [0058]); R11 is hydrogen (paragraph [0065]); L is NR14 (paragraph [0071]); and R14 is H (paragraph [0071]). '492 further teaches examples of Formula IV which include Example 29 and Example 30 (paragraphs [00332]-[00334]):
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Example 29 contains the same core structure as the instant compound and Example 30 has an N-alkyl group as found in the instant compound. Examples 29 and 30 are further described as having utility as B-RafV600E inhibitors each with an IC50 of less than 900 nM (paragraphs [00204]-[00206]). '429 also teaches a pharmaceutical composition of the reference compounds and a pharmaceutically acceptable carrier or excipient (paragraph [0024]; claim 21). However, '429 does not teach the instant compound.
Wenglowsky teaches Compound 16 (the same compound as Example 29 of '429) which inhibits B-RafV600E with an IC50 of 2 nM and desirable ADME characteristics (pg. 1925, Table 2; pg. 1925, column 2; and pg. 1926, Table 5).
Liu teaches that the mutated protein B-RafV600E has a 500-fold higher kinase activity than the wild-type B-Raf protein with links to a number of cancers including melanoma, ovarian, colon, and thyroid cancers (pg. 2215, columns 1-2). Liu further teaches that inhibitors which target both the WT and mutated B-Raf protein, may result in a paradoxical activation of the MAPK pathway which B-Raf inhibitors are meant to reduce (pg. 2216, column 1). Liu teaches the MAPK pathway activation in cancer cells can be reduced by inhibitors which selectively target the mutated B-Raf protein over the WT protein (pg. 2216, column 2). Liu further teaches optimizing a B-Raf inhibitor using the same sulfonamide groups as '429 and the instant claims, specifically Liu varies an aryl sulfonamide (pg. 2220, Table 2, Compounds 4a-k), alkyl sulfonamide (pg. 2221, Table 3, Compounds 5a-p), or sulfonamide group (pg. 2222, Table 4, compounds 6a-i). Liu teaches that the alkyl sulfonamide group of Example 29 in '429 and Compound 16 in Wenglowsky has similar selectivity for both the WT and mutated B-Raf protein, whereas the sulfonamide group found in the instant claims has increased selectivity for the mutated B-Raf protein versus the WT B-Raf protein (see Compounds 5b and 6b for comparison).
Based on the teachings of '429, Wenglowsky, and Liu, a person of ordinary skill in the art would modify the B-Raf inhibitor taught by '429 and Wenglowsky by replacing the alkyl sulfonamide group with the sulfonamide group taught in Liu and so arrive at the instantly claimed compound. The artisan would be motivated to perform this replacement to increase the selectivity of Example 29 for B-RafV600E over the WT B-Raf protein to reduce the unwanted activation of the MAPK pathway in cancer. The artisan would have a reasonable expectation of success that making this swap would maintain the compounds activity versus the B-Raf protein based on the teachings of '429, Wenglowsky, and Liu.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625