DETAILED ACTION
Claims 1, 4-12 are pending in the instant application.
Claims 1, 4-9, 11-12, wherein
1)-b)-i) serine palmitoyltransferase (SPL/SPTLC)
2)-b)-i) small molecules from Table A=compound 4 are examined. Claim 10 and the remaining subject matter of claims 1, 4-9, 11-12 are withdrawn per 37 CFR 1.142(b).
The requirement is still deemed proper and is therefore made FINAL.
The rejection of claims 1, 4-9, 11-12 under 35 U.S.C. 102(a)(1) and dated) over Asano et al., US 10519110 and Adachi et al., and Kojima et al. is withdrawn in view of applicant’s amendment and argument in paper dated on 09/04/2026.
4. Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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.
Claim 11 is rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. The term “Table A” is indefinite. Claim should be completed as written. Applicants need to insert the “Table A” to the instant claim. “Incorporation by reference to a specific figure or table of properties is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table in to the claim. Incorporation by reference is a necessary doctrine, not for applicant’s convenience.”(Ex part Fressola, 27 USPQ2d 1608 (Bd. Pat. App. & Int. 1993)) and (see MPEP 2173.05(s)).
5. Claims 1, 4-9, 11-12 are rejected under 35 U.S.C. 112, first paragraph, because the specification, does not reasonably provide enablement for preventing frailty. The specification does not enable any person skilled in the art to which, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. Applicants are not enabled for preventing any of these diseases. The only established prophylactics are vaccines not the compounds such as present here. In addition, it is presumed that “prevention” of the claimed diseases would require a method of identifying those individuals who will develop the claimed diseases before they exhibit symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted.
“The factors to be considered [in making an enablement rejection] have been summarized as the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art, and the breadth of the claims”, In re Rainer, 146 USPQ 218 (1965); In re Colianni, 195 USPQ 150, Ex parte Formal, 230 USPQ 546. 1) As discussed above, preventing diseases requires identifying those patients who will acquire the disease before occurs. This would require extensive and potentially opened ended clinical research on healthy subjects. 2) The passage spanning line 31, page 39 to line 32, page 40 lists the diseases Applicant intend to treat. 3) There is no working example of such a preventive procedure in man or animal in the specification. 4) The claims rejected are drawn to medical treatment and are therefore physiological in nature. 5) The state of the art is that no general procedure is art-recognized for determining which patients generally will become afflicted before the fact. 6) The artisan using Applicants invention would be a Board Certified physician who specialized to treat diseases with an MD degree and several years of experience. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prevention of disorder diseases generally. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable to any agent to be able to prevent disorders generally. That is, the skill is so low that no compound effective generally against disorders has ever been found let alone one that can prevent such conditions. 7) It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved", and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). 8) The claims broadly read on all patients, not just those undergoing therapy for the claimed diseases and on the multitude of compounds embraced by Formula (I).
The Examiner suggests deletion of the word “prevention”.
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Niloofar Rahmani whose telephone number is
571-272-4329. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor, can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 703-872-9306.
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/NILOOFAR RAHMANI/ Primary Examiner, Art Unit 1691
09/09/2026
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