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 the Claims
Claims 1-17 are pending. Claims 2, 7, 10, and 14-17 are withdrawn. Claims 1, 3-6, 8-9, and 11-13 are rejected.
Priority
This is a 35 U.S.C. 371 National Stage Filing of International Application No.
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, which claims priority under 35 U.S.C. 119(a-d) to
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. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d).
Information Disclosure Statements
The Information Disclosure Statements (IDS) from 9/20/2023, 6/24/2025, 9/16/2025, 2/3/2026, and 3/30/2026 were considered by the Examiner.
Election/Restrictions
Applicant’s election without traverse of Group I and the following species:
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, which is embraced by a compound of Formula III in instant claim 1:
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, wherein X = O; Y = CH2; R3d is linked to R3e to form -CH2CH2-; R3f = H; L3 = O; R6 =
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; W = C-F; Ring A =
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; in the reply filed on 3/30/2026 is acknowledged.
Claims 1, 3-6, 8-9, and 11-13 embrace Applicant’s elected species and are therefore under examination. As per MPEP 803.02, “Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability.” Applicant’s elected species is not allowable. An additional non-elected species was discovered incidental to the search of the elected species and is presented below in the interest of compact prosecution.
Claims 2, 7, 10, and 14-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, p. 205, line 6: Insert an “or” before “R251 and R252, together with a nitrogen”;
Claim 1, p. 205, line 9: Insert an “or” before “R253 and R254”;
Claim 1, p. 206, line 7: “simultaneously” is spelled incorrectly;
Claim 1, p. 210, line 12: “simultaneously” is spelled incorrectly;
Claim 1, p. 211, third line from the bottom: Insert an “or” before “R251 and R252, together with a nitrogen”;
Claim 1, p. 212, line 1: Insert an “or” before “R253 and R254,”;
Claim 1, p. 213, line 12: “simultaneously” is spelled incorrectly;
Appropriate correction is required.
Claim 8 is objected to because of the following informalities:
Claim 8, p. 215, line 20: Insert an “or” before “R251 and R252, together with a nitrogen”;
Claim 8, p. 215, line 23: Insert an “or” before “R253 and R254”;
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4, 5, 8, 9, 11, and 13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gazzard et al. (US20220281893-priority date of 2/9/2021).
Regarding instant claims 1, 4, 5, 8, 9, and 11, Gazzard et al. discloses the following compound on p. 171:
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, which is embraced by a compound of instant formula II-1:
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, wherein Y = CH(CH3); X = O; L3 = O; R6 = L-heterocyclyl:
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; W = C-F, R20 = halogen, fluroine; R2 = halogen (Cl); Ring A = aryl (phenyl), R1 = hydroxyl; n1 = 1; R3 = H.
Regarding instant claim 13, Gazzard et al. discloses the following in para. [0300]: “Also provided herein are pharmaceutical compositions comprising compound or a stereoisomer, atropisomer, tautomer, or pharmaceutically acceptable salt thereof as described herein and one or more pharmaceutically acceptable excipients.”
Claim(s) 1, 3-6, 8-9, and 11-13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Han et al. (US20240199644-priority date of 3/7/2021).
Regarding instant claims 1, 3-6, 8-9 and 11-12, Han et al. discloses the following compound on p. 178 (second compound down):
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, which has identical connectivity to applicant’s elected species (compound in claim 12, top of p. 217) and is embraced by a compound of instant formula III:
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, wherein X = O; Y = CH2; R3d is linked to R3e to form -CH2CH2-; R3f = H; L3 = O; R6 = L-heterocyclyl substituted by R35 (halogen),
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; W = C-F, R20 = halogen (F); Ring A =
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, n1 = 3, R1 = C2 alkynyl, halogen (F), and hydroxyl. Specifically regarding instant claim 3, the prior art is embraced by instant Formula III-1c2:
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, wherein R3 = H.
Regarding instant claim 13, Han et al. discloses the following in para. [0132]-[0133]: “A pharmaceutical composition comprising compound, a stereoisomer thereof, an atropisomer thereof, a pharmaceutically acceptable salt of the stereoisomer thereof or a pharmaceutically acceptable salt of the atropisomer thereof….and at least one pharmaceutically acceptable excipient”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGHAN C HEASLEY/ Examiner, Art Unit 1626