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
Claims 1-5, 8-9, 12-13, 16-17, 21-22, 25 and 27 are pending in the instant application.
Claims 1-4, 21-22, 25, and 27 are amended.
Claims 5, 8-9, 12-13, and 16-17 are cancelled.
Claims 28-31 are new.
Claims 1-4, 21-22, 25 and 27-31 are examined herein.
Priority
Acknowledgement is made of the applicant’s claim for foreign priority and the submission of the certified translations on 9/17/2025.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 20 December 2022 and 09 December 2024, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 15 September 2025 has been entered.
In view of applicant amendment to claims 25 and 27, the 112(a)-enablement of record is withdrawn.
In view of applicant amendment to claim 4, the 112(b) of record is withdrawn.
With respect to the 103 rejection, Applicant amendment has been considered but is not found persuasive for at least the following reasons. Applicant argues the instant invention delivers unexpected results by means of higher inhibition. The applicant presents data analysis not present in the specification to validate this assertion. Arguments presented in Applicant remarks are not considered evidence. As a result, the rejection is maintained and amended to include the new claims. Examiner suggest submitting an affidavit so the evidence can be considered.
All rejections and objections not found below have been withdrawn.
MAINTAINED REJECTIONS
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) 1-4, 21-22, 25 and 27-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (WO2021018003A1, priority date 26 July 2019).
Regarding claim 1, Xiu discloses a compound of Formula (I) (pictured below), which encompasses species of the instant genus of the instant Formula (I) when:
R1 is amino or C5-6- heterocycle
R2 is halogen, NH2, C1-6- alkyl, or C1-6 haloalkyl
R3 is H, halogen, C1-6- alkyl, or C1-6 haloalkyl
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Liu does not disclose the substituents on the right most phenyl to be on carbons 4 and 5, but on carbons 5 and 6, according to the generic labeling of carbons pictured below.
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The reference Formula (I) is a position isomer of the instant formula (I). To arrive at the instant formula (I) the methyl group para to the dimethyl phosphine oxide would need to be modified to the ortho position. This modification would be prima facie obvious to one of ordinary skill in the art as the compounds would remain structurally similar and would be expected to share the same utility. See MPEP 2144.09.II.
Regarding claims 2 and 3, Liu discloses a methyl ether (corresponding to the instant R1), R1 as amino or C5-6- heterocycle (corresponding to the instant R2), R2 as halogen, C1-6- alkyl, or C1-6 haloalkyl (corresponding to the instant R3), R3 as halogen, C1-6 alkyl, or C1-6 haloalkyl (corresponding to the instant R4), and a dimethyl substitution on the phenyl group corresponding to a position isomer of the instant R5 and R6 substituents.
Regarding claim 4, Liu discloses R1 as amino or C5-6- heterocycle (corresponding to the instant R2), wherein the C5-6- heterocycle can be substituted with a C4-6- heterocycle; R2 as C1-6- alkyl, or C1-6 haloalkyl (corresponding to the instant R3), R3 as halogen, C1-6 alkyl, or C1-6 haloalkyl (corresponding to the instant R4), and a dimethyl substitution on the phenyl group corresponding to a position isomer of the instant R5 substituent.
Regarding claim 21, Liu discloses the preferred embodiments pictured below (left side). Reference compound 1 is an analog of the first compound recited in claim 21. The only modification needed to arrive at the instant compound is substitution of the methyl ortho to the dimethyl phosphine oxide with a hydrogen.
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Reference compound 2 (below, left) would only need R3 to be methyl instead of chloro, which is taught by Liu, and to substitute the methyl ortho to the dimethyl phosphine oxide with a hydrogen to arrive at the instant compound on the right.
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Reference compound 12 (below, left) would only require substitution of the methyl ortho to the dimethyl phosphine oxide with a hydrogen to arrive at the instant compound on the right.
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Reference compound 17 (below, left) would only require substitution of the methyl ortho to the dimethyl phosphine oxide with a hydrogen to arrive at the instant compound on the right.
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Regarding claim 22, Liu discloses a pharmaceutical composition of a compound of Formula (I) (claim 15).
Regarding claim 25, Liu discloses a method of treating EGFR-mediated cancer (claim 17).
Regarding claims 27 and 30-31, Liu discloses the method wherein the cancer is colon cancer, thyroid cancer, lung cancer, leukemia, pancreatic cancer, melanoma, kidney cancer, prostate cancer, ovarian cancer, or breast cancer.
Regarding claims 28 and 29, Liu discloses the substituent corresponding to the instant R1 to be methyl, the instant R2 to be C5-6- heterocycle, the instant R3 to be C1-6- alkyl, the instant R4 to be C1-6 haloalkyl, and a dimethyl substitution on the phenyl group corresponding to a position isomer of the instant R5 and R6 substituents.
Conclusion
Claims 1-4, 21-22, 25 and 27-31 are rejected.
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 Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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