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 Claims
Claims 1-3, 6, and 9-12 are pending.
Priority
Instant application 18/578,384, filed 01/11/2024 claims priority as follows:
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Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
All references from the IDSs received 06/13/2026 have been considered unless marked with a strikethrough.
Response to Amendment/Arguments
The amendment filed 7/20/2026 has been entered. Claims 1-3, 6, and 9-12 are amended. Claims 4-5, 7-8, and 13-14 have been cancelled.
Claims 13-14 were previously rejected under 35 U.S.C. 112(b) and 35 U.S.C. 101 as “Use” claims. Claims 13-14 have been canceled, rendering the rejection moot. Therefore, the previous rejections of claims 13-14 under 35 U.S.C. 112(b) and 35 U.S.C. 101 are withdrawn.
Claims 1-14 were previously rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. In view of the amendment to the claims replacing the term “isomer” with “optical isomer”, and cancellation of claims 13-14, applicant has overcome the rejection. Therefore, the previous rejection of claims 1-14 under 35 U.S.C. 112(a) is withdrawn.
Claims 13-14 were previously rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. Claims 13-14 have been canceled, rendering the rejection moot. Therefore, the previous rejection of claims 13-14 under 35 U.S.C. 112(a) is withdrawn.
Claims 1-14 were previously rejected under 35 U.S.C. 103 as unpatentable over WORTMANN (US 20170216304 A1) as evidenced by FLEMING (Journal of Medicinal Chemistry, vol. 53, no. 22, Nov. 2010, pp. 7902–17). In view of the amendment to the claims requiring that R2 and R3, together with the carbon atom to which they are attached, form a cycloalkyl or heterocycloalkyl, applicant has overcome the rejection. Therefore, the previous rejection of claims 1-14 is withdrawn.
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 1-3, 6, and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over WANG (US 20240043419 A1; filed 27 September 2021; effectively filed 27 September 2020).
Wang discloses (page 3, [0024]) the compound of Formula (I):
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,
Wherein R1 is (page 3, [0026]):
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;
D1 is O or S (page 3, [0027]);
R13 is H, F, Cl, Br, I, OH, NH2, CN, COOH, or C1-3 alkyl (page 3, [0029]); and
R2 is H, F, Cl, Br, I, OH, or NH2 (page 3, [0033]).
Additionally, Wang discloses that in some embodiments, R1 is (page 3, [0035]):
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The genus of [0035] in Wang is relatively small, and only encompasses the following compound formulas:
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or
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.
The variable R2 is defined as H, F, Cl, Br, I, OH, NH2, CN, COOH, or C1-3 alkyl (page 3, [0030]). Applying the [0030] definition of R2, the genus in [0035] comprises 39 compounds (3 x 13 R2 options). A narrower definition of R2 for Formula (I) is provided in [0033], and states that R2 is H, F, Cl, Br, I, OH, or NH2. Applying the [0033] definition of R2, the genus in [0035] comprises 21 compounds (3 x 7 R2 options).
Wang discloses the specific compound (page 4, [0037]):
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The above compound differs from the instant claims by the C-F moiety at the position of X in instant Formula (1). However, as noted above, Wang teaches other substituents at that position, including a hydrogen atom.
Finding of prima facie obviousness
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (B) and/or (G), it would have been prima facie obvious to substitute the C-F bond in Wang’s disclosed embodiment for a C-H bond in view of the R2 variable definition disclosed in Wang’s Formula (I). A person having ordinary skill would have been motivated to substitute the C-F bond for a C-H bond to prepare additional compounds having ATR inhibitory activity, and would have enjoyed a reasonable expectation of success in view of Wang’s narrow disclosure of R2 variables.
The compound resulting from the substitution of C-F for C-H has the formula:
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, wherein R2 in the formula of [0035] is H.
The above compound reads on the instant claims because it is identical to compound 29 recited in instant claim 11:
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.
Please also note that Wang teaches that D1 in the moiety
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is selected from O or S. It would have therefore been prima facie obvious to substitute the oxygen atom in the ring of Wang’s compound to arrive at a compound having the formula:
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The above compound reads on the instant claims because it is identical to compound 30 recited in instant claim 11:
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With respect to claim 12, Wang teaches pharmaceutically acceptable dosage forms and compositions (see e.g. para. [0040]). It would have therefore been prima facie obvious to prepare a pharmaceutical composition comprising the compounds taught by Wang and a pharmaceutically acceptable excipient or carrier.
Therefore, claims 1-3, 6, and 9-12 are rejected over Wang.
Conclusion
Claims 1-3, 6, and 9-12 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 Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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