DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
2. The rebuttal arguments filed on January 29, 2026 have been fully considered. The arguments are sufficient to overcome the outstanding prior art rejection over Mainolfi et al. which is withdrawn.
3. The objection of claim 17 is maintained.
4. Pursuant MPEP 803.02 the search was expanded. Prior art was found that anticipates the Markush claims with respect to a nonelected species. Therefore, the claims were rejection and claims to nonelected species were held withdrawn from further consideration. The claims were searched and examined to the extent of the elected species, the species of claim 17 (see office action dated October 27, 2025) and additionally the species shown below.
5. A new ground of rejection is set forth in this office action.
Claim Rejections - 35 USC § 112
6. Claims 1, 2, 7-16 and 18 rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claims 1, 2, 7-16 and 18 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the compounds of formula I have variable ring structures as a core due to A, B, and C.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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)(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.
6. Claim(s) 1, 2, 7-9, 11-16 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2017009806. The reference has a publication date of January 19, 2017 which antedates the present claims having an effective filing date of April 28, 2021 and priority claim to provisional application dated April 28, 2020.
The reference teaches IRAK inhibitors of general structure
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, pharmaceutical compositions thereof, and various embodiments of the general structure, for example,
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(page 91, compound 44). The specific embodiment corresponds to the present claims in the following manner: B =
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; A=pyridine; R1=CF3; L1=-CON(R=H); C=pyridine; R3=
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or NR2 where R forms a ring and is substituted (see paragraph [0026]).
Conclusion
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/SUN JAE YOO/Primary Examiner, Art Unit 1621
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