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 Aug. 26, 2024, the applicants have canceled claims 2-51, 53, 55-57 and 59-65 and furthermore, have amended claims 1, 52, 54 and 58.
Claims 1, 52, 54 and 58 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, 52, 54 and 58 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 diethylamine salt and diethanolamine salt of instant compound of claim 1, does not reasonably provide enablement for preparing and using hydrates and solvates of this compound. 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, 52, 54 and 58 for hydrates and solvates of instant compounds of claim 1, there is no teaching or guidance present in the specification for preparing any specific hydrates (mono, di, tri or tetra) or solvates. Preparation of specific hydrates or 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 hydrates or 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 hydrate or solvate of instant compounds of claim 1. 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 hydrates or solvates of instant compounds of claim 1 with enhanced stability properties.
Regarding enablement rejection of instant claims 54 and 58 for methods of treatment, the specification teaches that the instant compounds are SIPI agonists. Based on these teachings, the instant compounds will have therapeutic utility for treating specific disease conditions where SIPI agonists are well known in the art to have therapeutic utility. However, there is no teaching either in the specification or prior art references provided showing well established utility of SIPI agonists for treating all the disease conditions listed in instant claim 58 including psoriasis, hepatitis, gastritis, diabetes, acne etc. There are no working examples present showing efficacy of instant compounds in animal models of all the disease conditions listed in instant claim 58 including psoriasis, hepatitis, gastritis, diabetes, acne etc. 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 58 including psoriasis, hepatitis, gastritis, diabetes, acne etc. and hence their utility for treating these disease conditions.
7. 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.
8. 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.
9. Claim 54 is 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.
In claim 54, specific diseases associated with either hyperactivity or hypoactivity of SIPI, are not defined.
Allowable Subject Matter
10. The following is a statement of reasons for the indication of allowable subject matter: The instant claims directed to crystalline forms of diethylamine salt and diethanolamine salt of compound of claim 1, are allowable over the prior art since they are neither disclosed nor obvious over the prior art. In the prior art, Jones (WO 2010/911316 A1, cited on applicant’s form 1449) discloses compound 12 (see page 36) and its salts, hydrates and solvates (see claims 35 and 36). However, there is no teaching, suggestion or motivation for preparing instant crystalline forms of diethylamine salt and diethanolamine salt of compound 12 disclosed by Jones.
11. 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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