DETAILED ACTION
This action is in response to Applicant’s submission dated December 1, 2025, in which Applicant elected the invention of Group I and amended claims 28, 33, and 46.
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 .
Information Disclosure Form
The references contained in the IDS dated December 1, 2025; June 21, 2024; April 15, 2024; December 4, 2023; and September 11, 2023 are made of record.
Election/Restriction
Applicant’s election of Group I in the reply filed on December 1, 2025 is acknowledged. 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)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-2, 4, 11-12, 15, 23-26, 28, 33, 37-39, and 45-49 (all in part) are examined. A complete reply to the final rejection must include cancellation of non-elected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
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.
Claims 38-39 and 45-49 are rejected under 35 U.S.C. 112(a), because the specification, while being enabling for a compound according to Formula (I) in Claim 1 being Compound No. 1, 1A, 1B, 2A, 2B, 3A, 3B, 4, 5, 6, 7A, 7B, or 8A, it does not reasonably provide enablement for a compound having the structure in Claim 1 outside of these cited compounds.
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 or use the invention commensurate in scope with these claims.
Undue experimentation is a conclusion reached by weighing the noted factual considerations set forth below as seen in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). A conclusion of lack of enablement means that, based on the evidence regarding a fair evaluation of an appropriate combination of the factors below, the specification, at the time the application was filed, would not have taught one skilled in the art how to make the full scope of the claimed invention without undue experimentation.
These factors include:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The breadth of the claims - The nature of the invention
The currently pending invention is drawn to compounds according to Formula (I), wherein the definitions of n1a, n1b, R1, n2, R2, R3, R3s, and R2s are defined therein. Compounds according to this formula are useful for inhibiting inflammasome activity or treating a disease or disorder in a subject, such as inflammatory, autoinflammatory and autoimmune diseases and cancers.
The state of the prior art
A review of the literature provided by Applicant in the Information Disclosure Statement (IDS) and the CAS structure search results suggests that the state of the prior art is limited as there is only one anticipatory reference found by the Examiner, see infra.
The level of predictability in the art
The synthesis of complex natural products is an integral part of modern organic chemistry, however, even the synthesis of molecules or molecular fragments containing ten carbons or less can also pose great challenges. Examination of many synthetic endeavors, large and small, reveals that formation of the carbon skeleton by carbon-carbon bond forming reactions requires the most strategic planning. The largest number of actual chemical reactions in a synthesis, however, usually involves manipulation of functional groups (Smith, M. B. Organic Synthesis, McGraw-Hill, Inc. 1994, Chapter 1). The functional group substitution of the many possibilities for the instant R group moieties changes the necessary starting materials for making these compounds as well as the predictability of their chemical reactivity. The functional group difference influences the bond length, electronegativity, and therefore the localization of electrons with respect to the functionality, which results in a lack of said predictability in their preparation. Therefore, it is unpredictable to know, from the outlined methods in the instant specification, how to make all of the compounds claimed in the formula (I).
The amount of direction provided by Applicant
The instant specification is not seen to provide adequate guidance, which would allow the skilled artisan to extrapolate from the disclosure and examples provided, to make the claimed invention commensurate in the scope with the instant claims.
The existence of working examples
The working examples set forth in the instant specification are directed to the compounds of Formula (I) as set forth in Compound No. 1, 1A, 1B, 2A, 2B, 3A, 3B, 4, 5, 6, 7A, 7B, or 8A in Table 1 of the specification, pages 37-40. There has not been provided sufficient evidence that would warrant the skilled artisan to accept the data and information provided in the working examples as correlative proof that any compound of Formula (I) other than these exemplified in Table 1 would indeed be able to be made by means of the methods outlined in the specification and rejected claims.
The quantity of experimentation needed to make and use the invention
In view of the information set forth supra, the instant disclosure is not seen to be sufficient to enable the preparation of any compound of Formula (I) as defined other than those exemplified in Table 1. One skilled in the art could not make the entire scope of the claimed invention without undue experimentation. Undue experimentation would include, for instance: preparation of the necessary starting materials required for each of the compounds according to the Formula (I), followed by attempts to prepare a desired product for each of the different functional groups, subsequently followed by isolation, characterization, and testing the various compounds to determine if indeed they had utility for the treatment of various diseases.
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.
Claims 1-2, 4, 11-12, 23-26, 28, 37-39, and 45-49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harrison, et al., WO 2019/121691, which teaches compounds of Formula (I) used for inhibiting the maturation of cytokines of the IL-1 family by inhibiting inflammasomes and may be used in the treatment of disorders in which inflammasome activity is implicated, such as inflammatory, autoinflammatory and autoimmune diseases and cancers, which include instant compounds. Specifically, the compounds with the structures:
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238
326
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of the reference anticipates the aforementioned claims where n1a and n1b are each independently 1, R1 is 6-member cyclic ring substituted with methyl, n2 of R2 is 1 or 2, R3 is 5-membered heteroaryl substituted with one R3s that is C1 alkyl, R2s is either a 4- or 6-membered heterocycloalkyl in which at least one heteroatom is O unsubstituted or R2SS is C1 alkyl in compound or pharmaceutically acceptable Na+ salt form. The references compounds exhibit the same activity as the compounds of the instant claims.
Claim Objections
Claims 15 and 33 are objected to as being dependent upon rejected independent claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claims and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ERICH A LEESER whose telephone number is (571) 272-9932. The Examiner can normally be reached Monday through Friday from 10-6 PST, M-F. PST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Mr. James Alstrum-Acevedo can be reached at (571) 272-5548. The fax number for the organization where this application is assigned is 571-273-8300.
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/ERICH A LEESER/Primary Examiner, Art Unit 1622
United States Patent and Trademark Office
Tel. No.: (571) 272-9932