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 .
DETAILED ACTION
Status of the Claims
Claims 1-4, 7-20, and 26-32 are pending and are examined on their merits.
35 U.S.C. § 112(b) Rejections Overcome by Amendment
Applicant’s amendment to claim 4 in the response filed on March 17th 2025 is acknowledged. Applicant has amended the claim to further limit R4 instead of R3. As claim 4 is now further limiting to claim 1, the 112(b) rejection over claim 4 is withdrawn.
Claim Objections Overcome by Amendment
Applicant’s amendment to claim 1 is acknowledged. Applicant has amended claim 1 to complete the previously recited limitation for option (viii) of Z1, thus overcoming the objection for claim 1.
35 U.S.C. § 102(a)(1) Rejections Overcome by Amendment
Applicant has amended the claims to no longer encompass the structures of Boes, Young, Xu, CAS RN 1519825-56-9, CAS RN 1009038-75-8, and Hinklin. All 102 rejections are thereby withdrawn.
Claim Rejections - 35 USC § 102 – Necessitated by Amendment
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 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 1, 2, 3, 4, 9, 12, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu (Xu et al., The Journal of Organic Chemistry 2016 81 (22), 11081-11094).
Xu teaches CAS RN 2036080-77-8:
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(Xu, pg. 11085, compound 4p).
Xu’s compound anticipates claims 1, 2, 3, 4, 9, 12, and 15.
Claims 1, 2, 8, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stambuli (US20100056800 A1).
Stambuli teaches CAS RN 1213236-31-7:
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(Stambuli, pg. 7).
Stambuli’s compound anticipates claims 1, 2, 8, 14, and 15.
Claims 1, 2, 3, 4, 7, 9, 10, 12, 13, 15, 20, 26, 27, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song (WO 2017/120429 A1).
Song teaches CAS RN 2103352-29-8:
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(Song, pg. 257, 3-(N-t-butoxycarbonylaminomethyl)-1-(2-chloropyrimidin-4-yl)-1H-indole).
Song’s compound anticipates claims 1, 2, 3, 4, 7, 9, 10, 12, 13, and 15.
Song teaches pharmaceutical compositions of the compound (Song, pg. 519, claim 143), anticipating claim 20.
Song teaches the treatment of cancers such as non-small cell lung cancer with the compound (Song, pg. 520, claim 146), anticipating claims 26 and 31.
Song teaches the compound in combination with a K-Ras Inhibitor (Song, pg. 234, lines 10-15 and pg. 235 lines 8-16), anticipating claim 27.
Allowable Subject Matter
Claims 16-19, 28-30, and 32 are allowed.
Applicant has developed the generic compound,
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and particular species of the compound, which act as inhibitors for the YAP/TAZ-TEAD transcription process. The compounds of claim 19 are not found in the art. The generic compound of claim 18 includes features which distinguish it from the art. While the core structure,
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,
is not novel, the requirement that R9 is a pyrazole and that R10 is a C=O substituted carbon chain distinguishes the generic compound from the art. The closest structures of the art appear in Ince (WO 2012/007345 published on January 19th 2012). Ex:
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(Ince, pg. 198, specification, compound 2-71).
The instant generic structure shares the core structure with Ince, as well as the attached pyrazole. However, Ince requires an attached phenyl group at position R10, in contrast to the substituted carbon chain of the instant structure. As compounds of the generic structure of claim 18 are not found in the art and it is unclear how the differences between the structure and compounds known in the art would contribute to the activity of the compounds, the compounds of claims 18 and 19 are novel.
Applicant has further developed particular species of the generic invention,
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,
a series of indole, indazole, and related compounds that act as inhibitors for the YAP/TAZ-TEAD transcription process. The particular compounds defined by applicant are not found in the art.
Zbieg (U.S. Provisional Patent No. 63/283,138 published on November 24th 2021) claims TAZ-TEAD inhibitors containing similar structures to the instant claims. Ex:
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(Zbieg, claim 18 [left], instant compound 4, also found in claim 17 [right]).
However, while Zbieg’s structures are similar to the species exemplified in claims 16, 17, and 28, they are not identical, and it is unclear how the differences between Zbieg’s structures and the instant structures would contribute to the activity of the compounds. For these reasons, the compounds of claims 16, 17, and 28 are novel.
Consequently, claims 16-19, 28-30, and 32 are allowed.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629