Detailed Action
The present office action is in response to the response filed on 02 Jul 2026.
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
Claims 1, 11, 13, 16, 22, 35, and 37 of the pending application have been examined on the merits. Claims 12, 14, 23-27, 34, 36, and 38-41 are withdrawn (see “Response to Applicant Election” below). Acknowledgement is made of the amendments filed 05 Nov 2024. Acknowledgement is made of the cancellation of claims 2-10, 15, 17-21, and 28-33.
Priority
Applicants identify the instant application, Serial #: 18/678,013, filed 30 May 2024, as claiming priority from Provisional Application #: 63/505,807, filed 02 Jun 2023.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 06 Jun 2024 and 09 Sep 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Election
Acknowledgement is made of the remarks filed 02 Jul 2026.
Applicant’s election of Invention I, claims 1, 11-14, 16, 22, and 34-41, in the reply filed on 02 Jul 2026 is acknowledged. Applicant further elected Example 24 as the species of formula I:
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A search for the species returned prior art. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 12, 13-14, 34-37, and 39-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 23-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 18 May 2026.
Examiner notes that the relevant anticipation rejection below is based upon art which was found incidental to the search for the elected species. The additional art found is relevant to the claims addressing species which have the same core structure as the instant claims. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied in an effort to promote compact prosecution of the case.
Claim Warnings
Applicant is advised that should claim 1 be found allowable, claim 22 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The phrase “for use in therapy” is construed as an intended use and is therefore not a limitation.
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)(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.
Examiner notes that the anticipation rejection below is based upon art which was found incidental to the search for the elected species. The additional art found is relevant to the claims addressing species which have the same core structure as the instant claims. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied in an effort to promote compact prosecution of the case.
Claim(s) 1, 11, 16, and 22 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2024/145623 (provided in IDS 09/09/24), hereinafter ‘623. ‘623 was published 04 Jul 2024 and has an effective filing date of 30 Dec 2023.
Applicant claims are directed to compounds of formula I (claims 1, 11, and 22):
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Where X is =N-; R1 is optionally substituted bicyclo[3.1.1]heptane, piperidine, 8-azabicyclo[3.2.1]octane, or octahydroindolizine; R2 is -CH3; R3 is optionally substituted phenyl; and R5 is H or optionally substituted C1-6 alkyl. In the reply filed 02 Jul 2026, applicant elected the Example 24 as the species of formula I:
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Applicant further claims a pharmaceutical composition comprising a compound of formula I and a pharmaceutically acceptable carrier (claim 16).
‘623 teaches compounds III-6, III-8, III-10, III-12, III-33, III-54, and III-112 which are species of the instant formula I when X is =N-; R1 is piperidine substituted with one Ra; Ra is C1-6 alkyl; R2 is CH3; R3 is phenyl substituted with CF3, OH, C1-6 alkyl, halogen, or O-C1-6 alkyl; and R5 is H (pgs. 39-54). ‘623 further teaches a pharmaceutical composition comprising the compounds of the reference and one or more pharmaceutically acceptable excipients, carriers, or diluents (pg. 81, lines 1-3).
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 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, 11, 16, 13, 22, 35, and 37 is/are rejected under 35 U.S.C. 103 as being obvious over ‘623 further in view of WO 2020/005873 (provided in IDS 09/09/24), hereinafter ‘873.
‘623 teaches compounds of Formula (I) which have utility as NLRP3 inhibitors (Abstract and pg. 4):
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The compounds include 2-[4-methyl-7-[(3R)-1-methyl-3-piperidyl]imidazo[4,5-c]pyridazin-3-yl]-5-(trifluoromethyl)phenol which is given the identifier III-8 (pg. 39, III-8):
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Compound III-8 has an IC50 of 1-10 nM when testing for levels of IL-1ß related to NLRP3 inflammasome activity (pgs. 236-237, Table 1). ‘623 further teaches a pharmaceutical composition comprising the compounds of the reference and one or more pharmaceutically acceptable excipients, carriers, or diluents (pg. 81, lines 1-3). ‘623 also teaches the compounds of the reference are useful for treating diseases and disorders mediated by NLRP3 which includes Huntington’s disease (pg. 2, lines 13-26). However, III-8 differs from the instantly elected compound by having a substituted piperidine moiety in place of the unsubstituted 8-azabicyclo[3.2.1]octane.
‘873 teaches compounds with utility for treating Huntington’s disease which include compounds 32 and 36 (pg. 38):
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Both compounds have an IC50 in a Huntington’s disease assay of between 0.1 µM and 0.5 µM (pg. 200, Table 1).
MPEP § 2144.09(II) teaches, “compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2 groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.”
Based on the teachings of ‘623 and ‘873, the artisan would modify Compound III-8 and replace the piperidine moiety with the 8-azabicyclo[3.2.1]octanyl moiety of ’873 with a reasonable expectation of success that the compound would retain biological activity. The motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds would possess similar activity (i.e., they would be pharmacologically active NLRP3 inhibitors) with potential for better bioavailability and lower side effects. There would be a reasonable expectation of success in producing and using the instantly claimed compounds in view of the compound taught by ‘623.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.M./Examiner, Art Unit 1625
/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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