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 .
Application Status
The amendment filed on 7/14/2026 in response to the Non-Final Rejection of 6/08/2026 is acknowledged and has been entered.
Claims 1-2, 4-22, 24-28 and 30-39 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement filed on 7/14/2026 is acknowledged and have been considered except lined through.
Rejections Withdrawn:
The rejection of Claim 29 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention in view Applicants amendments.
The rejection of Claim(s) 39 under 35 U.S.C. 102(a)(2) as being anticipated by Bristol-Myers Squibb Company (WO2024/020084A1, 2024-01-25) referred to herein as Bristol-Myers is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 22, 24-25, 34-35 and 37-38 under 35 U.S.C. 102(a)(1) as being anticipated by Gilead Sciences, INC (WO2020/014468A1, 2020-01-16) referred to herein as Gilead, is withdrawn in view of Applicants amendments/arguments.
The rejection of Claim(s) 26 under 35 U.S.C. 103 as being unpatentable over Gilead Sciences, INC (WO2020/014468A1, 2020-01-16) referred to herein as Gilead, as applied to claims 22, 24-25, 34-35 and 37-38 above, in view of Buskes and Blanco (Molecules 2020; 25(15): 3493) is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 28-33 under 35 U.S.C. 103 as being unpatentable over Gilead Sciences, INC (WO2020/014468A1, 2020-01-16) referred to herein as Gilead, as applied to claims 22, 24-25, 34-35 and 37-38 above, in view of Bose and Jayalakshmi (Synthesis 1999; 1: 64-65) is withdrawn in view of Applicants amendments.
The provisional rejection of Claim 3 on the ground of nonstatutory double patenting as being unpatentable over claims 13-15 of copending Application No. 18759283 (reference application) is withdrawn in view of Applicants amendments.
Rejections Necessitated by Amendments:
Claim Rejections - 35 USC § 102
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.
Claim(s) 28 and 30-33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gilead Sciences, INC (WO2020/014468A1, 2020-01-16, cited in the prior office action) referred to herein as Gilead.
Gilead teach a compound having the formula
PNG
media_image1.png
224
507
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Greyscale
or pharmaceutically acceptable salt thereof (claim 5). Moreover, Gilead teaches a synthesis of 4-(((R)-l-cyanoethyl)amino)-6-(3-cyanopyrrolo[l,2-b]pyridazin-7-yl)-N-((R)-2-fluoro-3- hydroxy-3-methylbutyl)nicotinamide comprising the following reactions:
PNG
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355
486
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Greyscale
(page 49, Example 3). Note: TFAA is a carboxylic acid anhydride, pyridine is a base, LiOH is an inorganic base, wherein MeOH and LiOH is a hydrolyzing step.
Conclusion
Therefore, Claims 28 and 30-33 are rejected.
Claims 1-2, 4-22, 24-27 and 34-39. The closest prior art to the instant claims has been previously discussed in the prior office action.
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 BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
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