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 .
Election/Restrictions
Applicant’s election without traverse Group I (drawn to a compound of Formula I, or a pharmaceutically acceptable salt thereof), in the reply filed on 03/20/2026 is acknowledged.
Claims 1, 4-5, 8-9, 12-14, 18, 20, 27-28, 33, 36-37, 39-40, and 45 are pending of which, claims 39-40 and 45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected INVENTION, there being no allowable generic or linking claim. The restriction requirement is still deemed proper and is made Final.
Pending claims 1, 4-5, 8-9, 12-14, 18, 20, 27-28, 33, and 36-37 have been examined on the merits.
Please note, for clarity of the record, Applicant elects the following species, recited in claims 1, 4-5, 8-9, 12-14, 18, 20, 28, and 36-37:
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During the course of examination, prior art was identified that relates to the elected
subject matter. In the interest of compact prosecution, that prior art has been applied in the rejection, as discussed below.
Per MPEP 803.02, the Examiner determined that the elected species is not allowable over the prior art, therefore, the examination of the Markush claim was not extended. Additionally, claims 27-28, drawn to nonelected species, are withdrawn from further consideration.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1, 4-5, 8-9, 12-14, 18, 20, 33, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Moslin et al., US PG-PUB 2015/0299183 in view of Spergel et al., WO2020092196.
Regarding claims 1, 4-5, 8-9, 12-14, 18, 20, 33, and 36-37, Moslin (page 1, [0001]) teaches compounds useful in the modulation of IL-12, IL-23 and/or IFNa by acting on Tyk-2 to cause signal transduction inhibition. Moslin (page 102, [0549], circle was added around icon for emphasis) teaches compound of Example 200, wherein R1 is trideuteriomethyl; R2 is cyclopropane; X is nitrogen; R4 is methoxy; R5 is methyl
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substituted 1,2-diazole (pyrazole). While, Example 200 does not explicitly teach R5 is 1,2,4-triazole; however, Moslin (page 120) teaches that the R5 moiety can be, as an example, a 5-10 membered heterocycle containing 1-4 heteroatoms selected from N, O, and S. In addition, Moslin (page 76) discloses compound Example 141 containing the same core structure, wherein R5 is methyl substituted 1,2,4-triazole,
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. Given that Moslin teaches both 1,2-diazole and 1,2,4-triazole, as acceptable substituents for the R5 position, suggesting there are interchangeable heteroaryl option. Therefore, a person of ordinary skill in the art (POSITA) would consider replacing the pyrazole moiety with a 1,2,4-triazole as a part of a routine optimization to expand the library diversity at the R5 position.
It is important to note, the only structural distinction between the claimed compound and Moslin’s disclosure at R5 position, is the arrangement of the double bond and the relative positioning of the nitrogen atoms within the triazole ring. Furthermore, Moslin (page 125, circle was added around icon for emphasis) discloses alternative pyrazole structures exhibiting the same double-bond orientation and nitrogen placement
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, suggesting a positional isomer to the compound of Example 200. Therefore, a POSITA would recognize that these heterocycles represent alternative azolyl option within the same genus, and that the structural differences between the 1,2,4-triazol in the instant claim and as disclosed by Moslin, merely represent positional isomers, variants differing only in heteroatom placement and double bond-bond arrangement. In the same way that Moslin discloses positional isomer for the pyrazol, a POSITA would also expect positional isomer rearrangement for the 1,2,4-triazole at the R5 position. Therefore, a PSOITA would have reasonably substituted pyrazole with 1,24-traizole and repositioned the nitrogen and double bond to diversify the R5 position and arrive at the claimed invention, because this approach would allow expansion of the compound library.
Regarding R3 position, Moslin (page 120) does not explicitly disclose a compound bearing a fluorine substituent at the R3 position. However, Moslin (page 120) teaches that the
aryl ring connecting to the R3 position can be substituted with a halogen, including a fluorine. This suggests that a POSITA would recognize that such changes fall within the expected scope of routine optimization. Thus, a POSITA would have reasonably modified the disclosed aryl group of compound Example 200 to include a fluorine, because fluorine is a highly common and strategic substituent modification on benzene rings. For example, Spergel (abstract; page 1) teaches compounds useful in the modulation of IL-12, IL-23 and/or IFNa by acting on Tyk-2 to cause signal transduction inhibition. Spergel (page 244, circle was added around icon
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for emphasis) discloses compound 553, wherein R3 is a fluorine substituent. Therefore, a POSITA would have been motivated to modify Moslin’s teachings in view of Spergel’s disclosure by replacing the pyrazole with a 1,2,4-triazole and by introducing a fluorine substituent at the R3 position, because Moslin already teaches both these structural options as acceptable variations within the same chemical genus, and thereby arriving at the claimed invention through predictable structural modification as taught by Moslin in view of Spergel.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES H ALSTRUM-ACEVEDO can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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