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 .
According to a preliminary amendment filed on Sep. 12, 2024, the applicants have canceled claim 42 and furthermore, have amended claims 2-3, 5-30 and 37-41.
Claims 1-41 are pending in the application.
Claim Rejections - 35 USC § 112
4. 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 1-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for preparing and using salts of instant compounds of formula (I’), does not reasonably provide enablement for preparing and using solvates of instant compounds 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 following eight different factors (see Ex parte Foreman, 230 USPQ at 547; Wands, In re, 858.F. 2d 731, 8 USPQ 2d 1400, Fed. Cir. 1988) must be considered in order for the specification to be enabling for what is being claimed:
Quantity of experimentation necessary, the amount of direction or guidance provided, presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability and the breadth of claims. In the instant case, the specification is not enabling based on atleast four of the above mentioned eight different factors such as quantity of experimentation necessary, the amount of direction or guidance provided, presence of working examples, state of the prior art, unpredictability and the breadth of claims.
In regard to lack of enablement issue of instant claims 1-41 for solvates of instant compounds of formula (I’), there is no teaching or guidance present in the specification for preparing any specific solvates. Preparation of specific solvates of any compound is a very specialized field and involves their characterization using different techniques such as infrared spectrum, XRD powder diffraction etc. There is no teaching or guidance present in the specification regarding any specific solvents used for preparing specific solvates and their characterization using any techniques such as XRD powder diffraction or infrared spectrum etc. There is not even a single example present for preparing any specific solvate of instant compounds of formula (I’). Healy (Adv. Drug Deliv. Rev.) teaches that differences in solid forms (hydrates, solvates or polymorphic forms) often leads to differences in thermodynamic parameters and physiochemical properties such as solubility, dissolution rate, stability and mechanical properties (see abstract and table 1 on page 28). Therefore, in absence of such teachings, guidance, presence of working examples and unpredictability, it would require undue experimentation to select specific solvates of instant compounds with enhanced stability properties.
Regarding enablement rejection of instant claims 29-41 for treating various diseases, the specification teaches that the instant compounds are Kv 7.2 potentiators as shown in table 1 on pages 126-135. However, there is no teaching either in the specification or prior art references provided showing well established utility of Kv 7.2 potentiators for treating all the disease conditions listed in instant claim 30, including every known behavioral disorder, every known mood disorder, every known neurodegenerative disorder, epilepsy etc. There are no working examples present showing efficacy of instant compounds in animal models of all the disease conditions listed in instant claim 30, including every known behavioral disorder, every known mood disorder, every known neurodegenerative disorder, epilepsy etc. Therefore, in absence of such teachings, guidance, prior art and working examples, it would require undue experimentation to demonstrate efficacy of instant compounds in animal models of all the disease conditions listed in instant claim 30, including every known behavioral disorder, every known mood disorder, every known neurodegenerative disorder, epilepsy etc. and hence their utility for treating these disease conditions.
8. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 28-41 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 28 recites the limitation "formula (I)" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation "formula (I)" in claim 1. There is insufficient antecedent
basis for this limitation in the claim.
Claim 30 recites the limitation "formula (I)" in claim 1. There is insufficient antecedent
basis for this limitation in the claim.
Claims 29-41 are directed to use of compounds or pharmaceutical compositions for treating various disease condition. However, it is not clear who is being treated and furthermore, the steps of administration are also missing in the claims.
In claims 29 and 39-41, specific diseases associated with either hyperactivity or hypoactivity of Kv 7.2, are not defined.
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)(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.
Claims 1-4, 9-11, 15, 18, 20-21 and 28-41 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lebreton (WO 2023/091554 A1).
Lebreton discloses novel heteroaryl urea compounds for treating various diseases associated with Kv 7.2 (see claims 58-71). The compounds disclosed on pages 544-546 by Lebreton anticipate the instant claims when cyclopropyl is substituted with alkyl or cycloalkyl group (instant variable R6), variable A1 represents N and variable R1 represents an alkoxy group in the instant compounds of formula (I’).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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