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 with traverse of a compound in which variable A is pyridine and R1 is a phenyl ring in the reply filed on 2026 March 11 is acknowledged. The traversal is on the ground(s) that burden was not established in the restriction. This is not found persuasive because the only defined structural feature of a compound of formula (I) is an oxadiazole ring. Even though the claims does not permit CR3R4 to be methylene or NR1R2 to be NH2, there is a burden due to the following reasons: variable A represents any heteroaryl group; CR3R4 is a mono or disubstituted group or a cycloalkyl group; and NR1R2 represents a secondary or tertiary amino group as well as heterocyclic group. As a result of this burden, multiple searches are required to filter out proviso-ed compounds.
As a result of this search strategy, the elected species was found free of the prior art of record and a search of the whole scope of formula (I) has been done.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2023 October 24 and 2025 February 13 were submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being 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 21, 24, 27, 28, and 34 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 early onset epilepsy and non-enabling for treatment of the scope of disorders recited. 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.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
The nature of the invention and (2) the breadth of the claims:
The claims are drawn to treatment of a disorder with a compound of formula (I). Thus, the claims taken together with the specification imply a compound of formula (I) can treat a disorder recited in claims 21, 24, 27, 28, and 34.
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The state of the prior art and (4) the predictability or unpredictability of the art:
MIKATI (Annals of Neurology, 2015, 78 (6), 995-999) describes that more research is needed to understand the therapeutic efficacy of KCNT1 (page 997, column 2, last paragraph to page 998, column 2, last paragraph).
MCTAGUE (Neurology, 2018, 90 (1), e55-e66, page 24) describes the following ideas: KCNT1 is linked to early-onset epilepsy (page e61, column 2, paragraph 2); and that more research is required to understand the clinical relevance of KCNT1 (abstract).
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 [disease] 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 (7) the presence or absence of working examples:
The specification has provided guidance for the treatment of early onset epilepsy.
The specification does not provide guidance for the treatment of the scope of disorders recited.
The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to disorders related to KCNT1 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, 9, 12, and 15-20 are allowed. Claims 21, 24, 27, 28, and 34 are not allowed.
The following is a statement of reasons for the indication of allowable subject matter: KHOMENKO (Chemistry of Heterocyclic Compounds, 2016, 52(6), 402-408) describes compound 6 and 8. Neither of these compounds anticipate or render obvious a compound of formula (I) because CR3R4 cannot be methylene and NR1R2 cannot be NH2,.
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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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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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