DETAILED ACTION
Claims 1-20 are pending in the instant application.
2. Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 15-20 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. V. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). These claims are withdrawn from consideration.
3. 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 2 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.
Claim 2 is rejected because the term “old mammal” is confusing. What is “old mammal”? Does “old mammal” mean 30 years or older? Correction is required.
4. Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 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 1-14 are rejected under 35 U.S.C. 112, first paragraph, because the specification, does not reasonably provide enablement for treating and preventing any and all diseases. 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) There is no working example of such a preventive procedure in man or animal in the specification. 3) The claims rejected are drawn to medical treatment and are therefore physiological in nature. 4) 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”.
5. Claim Rejections - Obvious Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and, In re Thorington, 418 F.2d 528, 168 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130 (b).
Effective January 1,1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-20 are provisional rejected under the judicially created doctrine obviousness-type double patenting as being unpatentable over the claims 1-20 of ap# 18/392,229. Although the conflicting claims are not identical, they are not patentably distinct from each other because the current invention embraces the invention claimed in the above application.
Determination of the scope and content of the prior art (MPEP §2141.01)
Ap# ‘229 claimed analogues compound and method for ameliorating age-associated muscle degeneration in claims 1-20 as the instant claims 1-20.
Ascertainment of the difference between the prior art and the claims (MPEP §2141.02)
The difference between the instant claims and the claims 1-20 of ap# ‘229 is the claims are not word for word identical but the scope of the two sets of claims overlaps significantly with each other. For example, in claim 1 of ap#’229, “age-associated visual degeneration” can be “age-associated muscle degeneration in claim 1 of the instant claim.
Finding of prima facia obviousness-rational and motivation (MPEP §2142.2143)
All the elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
This is provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been issued.
6. Closest Art
The closest art is Yarosh et al., US 6,103,746, which discloses in the abstract L-ergothioneine may be prepared in a pharmaceutically acceptable carrier to form an agent for topical application to the skin for oxidative damage. Yarosh does not disclose L-ergothioneine can ameliorate age-associated muscle degeneration. Therefore, the claims are free of prior art.
7. 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/NILOOFAR RAHMANI/
02/24/2026