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 .
Response to Arguments
Applicant’s arguments, see Pages 4-8, filed 12/29/2025, with respect to the rejection(s) of claims 1-9 under Jang et al. (WO 2019190259 A1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Deng et al. (CN 112538072 A).
Applicant has additionally overcome the 112b rejection of claims 1-9 and the 101 rejection of claim 7 by the amendment of claims 1-3 and 7-9.
Applicant has canceled claims 7 and 9 and added claims 10-21. No new matter was added. Claims 1-6, 8 and 10-21 is pending. Claims 1-6, 8 and 10-21 is now evaluated on its merits.
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.
Claims 1-6, 8, 10-14 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Deng et al. (CN 112538072 A), published 03/23/2021 with an effective filing date of 09/21/2019.
Regarding claims 1-6, 8, 10-14 and 18-21, Deng teaches a method of treating EGFR (epidermal growth factor receptor) mediated cancers of lung cancer, including non-small cell lung cancer, T790M/C797S mutation, del19/T790M/C797S and L858R/T790M/C797S (relevant to claims 8 and 18-21) (abstract, Background last para., claims 27-29) comprising administration of Formula (I)
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or a stereoisomer thereof, a tautomer or a pharmaceutically acceptable salt, a prodrug, a hydrate, a solvate, an isotope-labeled derivative and a pharmaceutical acceptable carrier (relevant to claim 6) (claims 1 and 26). Of the above formula (I) Deng teaches:
R1 is selected from H, halogen, -CN, C1-6 alkyl, C1-6 alkoxy, C1-6 haloalkyl, C1-6 haloalkoxy, C3-6 cycloalkyl, 3-6 membered heterocycloalkane Group, C3-6 cycloalkyloxy, 3-6 membered heterocycloalkyloxy and C2-6 alkenyloxy.
M is selected from N or CH.
R2 is selected from H, halogen, -CN, -OH, -NH2, phosphono, sulfonyl, aminosulfonyl, aminocarbonyl, C1-6 alkyl, C1-6 alkoxy, C1-6 haloalkyl, C1- 6 haloalkoxy, C2-6 alkenyl, C2-6 alkynyl, C3-14 cycloalkyl, 3-14 membered heterocycloalkyl, C3-6 cycloalkenyl, C3-6 heterocycloalkenyl, phenyl ; Wherein, the -OH, -NH2, phosphono, sulfonyl, aminosulfonyl, aminocarbonyl, C1-6 alkyl, C1-6 alkoxy, C1-6 haloalkyl, C1-6 haloalkoxy, C2-6 alkenyl, C2-6 alkynyl, C3-14 cycloalkyl, 3-14 membered heterocycloalkyl, C3-6 cycloalkenyl, C3-6 heterocycloalkenyl, phenyl are optionally selected by one or Replaced by multiple R12 groups.
R3 is selected from C6-10 aryl, 5-12 membered heteroaryl, 3-8 membered heterocycloalkyl, C3-8 cycloalkyl, C3-6 cycloalkenyl, wherein the C6-10 aryl, 5-12 membered heteroaryl, 3-8 membered heterocycloalkyl, C3-8 cycloalkyl, C3-6 cycloalkenyl can be optionally substituted by one or more R13 groups.
R4, R5 are each independently selected from the group consisting of H, halogen, -CN, alkyl C1-6 C1-6 alkoxy, C1-6 alkyl, halogenated C1-6, cycloalkyl C3-8 3-8 membered heterocycloalkyl.
Alternatively, R4 and R5 are cyclized into 4-6 membered cycloalkyl, 4-6 membered heterocycloalkyl, 4-6 membered aryl, 4-6 membered heteroaryl (relevant to claim 3 and 12)
In particular embodiments Deng teaches
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(compound 126),
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(compound 190). The above compounds read to the limitations of claimed invention of R1 being option (4) of claim 1, option (2) of claims 2 and 10, option (1) of claim 3. R2 as methyl, R3 as H (relevant to claims 11, 13-14). Deng additionally teaches the preparation of compound 126 of
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,
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,
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(relevant to claim 5).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have developed the compounds
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,
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,
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. One would have been motivated to do so from the teachings of Deng of compounds 190 and 126 wherein R3 is a cyclopropyl and R5 is Cl. There is a reasonable expectation of developing compounds
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,
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and
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from the teachings of Deng.
Claims 1-4, 6, 8, 10-14 and 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Deng et al. (WO 2020253862 A1), published 12/24/2020, with a filing date of 06/21/2019.
Regarding claims 1-4, 6, 8 and 10-21, Deng teaches a method of treating EGFR mediated cancers of non-small cell lung cancer with EGFR T790M and C797S. /de119 resistance mutations (relevant to claims 18-21) comprising administration of
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in combination with an EGFR monoclonal antibody of Cetuximab and a pharmaceutical acceptable carrier (relevant to claims 6, 8 and 16-17) (abstract, claims 38-39). Of the above compound Deng teaches
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(page 65)
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(page 84),
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(page 241) (relevant to claims 1-3, 10-14).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have developed compounds
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,
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. One would be motivated to do so from the teachings of Deng of compounds
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and
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in which the NH is attached to the quinoxaline of compound 18. There is a reasonable expectation of developing compounds
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and
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from the teachings of Deng.
Allowable Subject Matter
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627