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 of group I in the reply filed on 2026 February 23 is acknowledged.
Claims 1, 4-6, 8, 11, 12, 20, 21, 23, 25, 30-32, 65, 80, and 81 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 68 and 69, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 2025 November 21 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2023 March 23, 2023 June 20, 2025 May 14, and 2026 March 5 were submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 68 and 69 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification is enabling for the treatment of atherosclerosis, type 2 diabetes, Alzheimer’s disease, obesity, stroke, Crohn’s disease, ischemic stroke, liver fibrosis, non-alcoholic steatohepatitis, rheumatoid arthritis, Parkinson’s disease, multiple sclerosis or amyotrophic lateral sclerosis with a compound of formula (I) and non-enabling for the treatment of the scope of diseases recited in claims 68 and 69 with a compound of formula (I). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Consideration of the relevant factors sufficient to establish a prima facie case for lack of enablement is set forth herein below:
The nature of the invention and (2) the breadth of the claims:
The claims are drawn to treating a disease with a compound of formula (I). Thus, the claims taken together with the specification imply a compound of formula (I) can treat a disease recited in claims 68 and 69.
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The state of the prior art and (4) the predictability or unpredictability of the art:
FUSCO (International Journal of Molecular Sciences, 2020, 21, 4223, 1-26) describes the following ideas: antagonism of NLRP3 is linked to the treatment of the following diseases: atherosclerosis, type 2 diabetes, Alzheimer’s disease, obesity, stroke, and Crohn’s disease (page 3 of 26, paragraph 2 to page 4 of 26, paragraphs 1 and 2), ischemic stroke (pages 7-8 of 26, section 6), liver fibrosis and non-alcoholic steatohepatitis (page 9 of 26, section 8), rheumatoid arthritis, Parkinson’s disease (pages 11-12 of 26, sections 11 and 12), multiple sclerosis and amyotrophic lateral sclerosis (pages 13-15 of 26, sections 14 and 15); and more research is needed to understand what disorders are linked to NLRP3 antagonism (pages 15 of 26, “conclusions” section).
The relative skill of those in the art:
While the artisan generally would have an advanced degree in [area of claims], their high level of skill and knowledge is insufficient to overcome the lack of understanding as to how NLRP3 functions in the body or to overcome the art recognition that this disease is poorly understood and treatments have generally failed.
The amount of direction or guidance presented and the presence or absence of working examples:
The specification has provided guidance for the in vitro inhibition of IL-1β (pages 138-139, example 46).
The specification does not provide guidance for the treatment of the scope of diseases recited in claims 68 and 69.
The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to treatment of the scope of diseases recited in claims 68 and 69 with a compound of formula (I) and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Conclusion
Claims 1, 4-6, 8, 11, 12, 20, 21, 23, 25, 30-32, 65, 80, and 81 are allowed. Claims 68 and 69 are not allowed.
The following is a statement of reasons for the indication of allowable subject matter: BEAUSOLEH (WO 2023/220408, published 2016 August 18, cited in 2026 March 5 IDS) describes compound 102 (page 187, claim 153). This compound does not anticipate or render obvious a compound of claim 1 because the reference was published on 2023 November 16, which postdates the effective filing date of 2022 March 15.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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