DETAILED ACTION
The preliminary amendment submitted on April 5, 2024 has been entered. Claims 2-21 are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
Objection to The Specification
The following is a quotation of 35 U.S.C. 132(a):
(a) Whenever, on examination, any claim for a patent is rejected, or any objection or requirement made, the Director shall notify the applicant thereof, stating the reasons for such rejection, or objection or requirement, together with such information and references as may be useful in judging of the propriety of continuing the prosecution of his application; and if after receiving such notice, the applicant persists in his claim for a patent, with or without amendment, the application shall be reexamined. No amendment shall introduce new matter into the disclosure of the invention.
The amendment filed April 5, 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is discussed below. Applicant is required to cancel the new matter in the reply to this Office Action.
Furthermore, the abstract is objected to because it does not accurately reflect the compound in the claims or the full scope of what is being claimed. There examples in the abstract that are not found in the claimed invention.
Claim Rejections – 35 USC § 112(a)
The following is a quotation 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.
Claims 2-21 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
The following claim limitations are new matter:
Claims 7, 14, and 19 recite “at least 5.0 mg/kg per day”.
Claims 8, 15 and 20 recite “0.5 to 250 mg/kg per day”.
Claim 11 recites “greater than 75 mg per day”.
Claim 12 recites “greater than 100 mg per day”.
Claim 13 recites “greater than 150 mg per day”.
The specification discloses the following:
Paragraph 00230 (pp. 50-51) of the originally filed specification discloses, “an oral dose of greater than about 75 mg per day in a human. In a further aspect, the disclosed compounds inhibit muscle atrophy when administered at an oral dose of greater than about 100 mg per day in a human. In a further aspect, the disclosed compounds inhibit muscle atrophy when administered at an oral dose of greater than about 150 mg per day in a human.”
Paragraph 00234 (p. 52) states that “[i]n one aspect, the compound is present in an amount greater than about an amount selected from 5 mg, 10 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 250 mg, 300 mg, 400, mg, 500 mg, 750 mg, 1000 mg, 1,500 mg, or 2,000 mg.”
Paragraph 00256 (p. 57) further states that “the treatment conditions which require modulation of cellular function related to muscle health, muscle function and/or healthy muscle aging an appropriate dosage level will generally be about 0.01 to 500 mg per kg patient body weight per day and can be administered in single or multiple doses. Preferably, the dosage level will be about 0.1 to about 250 mg/kg per day; more preferably 0.5 to 100 mg/kg per day. A suitable dosage level can be about 0.01 to 250 mg/kg per day, about 0.05 to 100 mg/kg per day, or about 0.1 to 50 mg/kg per day. Within this range the dosage can be 0.05 to 0.5, 0.5 to 5.0 or 5.0 to 50 mg/kg per day. For oral administration, the compositions are preferably provided in the [form] of tablets containing 1.0 to 1000 milligrams of the active ingredient, particularly 1.0, 5.0, 10, 15, 20, 25, 50, 75, 100, 150, 200, 250, 300, 400, 500, 600, 750, 800, 900 and 1000 milligrams of the active ingredient for the symptomatic adjustment of the dosage of the patient to be treated. The compound can be administered on a regimen of 1 to 4 times per day, preferably once or twice per day. This dosing regimen can be adjusted to provide the optimal therapeutic response.”
Regarding the phrase, “at least 5.0 mg/kg per day” there is no support for an amount with no upper limit. Thus, this is considered to be new matter.
Regarding the phrase, “greater than 75”, “greater than 100” and “greater than 150”, the specification specifically discloses “greater than about.” There is no support for these as absolutes.
Regarding the phrase, “0.5 to 250 mg/kg per day”, the specification specifically discloses “about 0.1 to about 250 mg/kg per day and about 0.01 to 250 mg/kg per day.” There is no support for absolutes for both the lower and upper ranges.
Thus, there is new matter in these claims.
Claims 2-21 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims are drawn to a method comprising administering to a subject, for example, a human (see, e.g., specification at p. 57). Applicant has not qualified a patient population. Everyone, in theory, would benefit from the treatments recited. The claims therefore read on implausible or impossible methods. For example, the claims include “treating sarcopenia” and “treating cachexia,” but how do you treat sarcopenia or cachexia in a person who does not even have these conditions?
Claim Rejections – 35 USC § 112(b)
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.
Claims 2-21 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim 2 states “thereby accomplishing one or more of (i)-(xix),” but there are only items (i) through (xii) listed earlier in the same claim. It is unclear what item “xix” would be. It is also unclear what the word “accomplishing” means.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 2-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5,679,828 A by Lee et al.
Lee discloses (see abstract) a method of administering to a human (col. 9, ll. 27-30) the compound of formula (I), which is known in the prior art as betulinic acid. “Typical dosages comprise about 0.1 to about 100 mg/kg body weight. The preferred dosages comprise about 1 to about 100 mg/kg body weight of the active ingredient. The most preferred dosages comprise about 10 to about 100 mg/kg body weight.” See Lee at col. 10, ll. 1-5. For a typical human of about 75 kg, “about 10 to about 100 mg/kg body weight” as taught by the reference (col. 10, l. 5) is equivalent to about 750 mg to about 7.5 g and therefore meets the limitations of claims 4-8 and 11-15.
The instant claims appear to represent applicant’s discovery of an inherent property of the therapy disclosed in Lee, namely, the effect of betulinic acid on muscle physiology. The discovery, however, of a previously unappreciated property of the prior art, or of a scientific explanation for its functioning, does not render it patentably new to the discoverer. The claiming of a new use, new function, or unknown property that is inherently present in the prior art—although not necessarily specifically disclosed therein—does not necessarily make the instant claims patentable. Just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art therapy also does not make it patentable. See MPEP 2112(I) (something which is old does not become patentable upon the discovery of a new property). Furthermore, there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is, in fact, inherent in a prior art reference. The fact that a characteristic is a necessary feature or result of a prior-art embodiment is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention. An inherent structure, composition, or function is not necessarily known. See MPEP 2112(II) (inherent feature need not be recognized at the relevant time).
It is the examiner’s impression that everyone, including the humans described in Lee, would benefit from “promoting normal muscle function” “promoting muscle health,” and “promoting healthy aging in muscles” as required by the instant claims. The cited reference discloses a method comprising the same step (administering) the same compound (betulinic acid) to the same subject (a human) in the same dosage amounts (discussed above), so it is a reasonable conclusion that the outcomes recited in the instant claims would necessarily follow. Stated another way, one would necessarily perform the treatment method of the instant claims by following the teachings of Lee. In fact, it appears that one would not necessarily even need to be aware of or have any information about the effects of betulinic acid on human muscle in order to perform the method. The examiner therefore concludes that claims 2-15 are anticipated based upon the principle of inherency.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The examiner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
January 28, 2026(revised February 12, 2026)