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 .1
Status of Claims
Claims 1-9 are pending and are directed to the compound, oxiracetam.2
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Election/Restrictions
Applicant’s election of the species, senile sarcopenia, in the reply filed on Jan 20 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Note upon further search and reconsideration of the claims, the examined species of muscle disease conditions treated by oxiracetam has been expanded to include myoclonus.
Further, the species of muscle diseases prevented by oxiracetam administration, has been expanded to include all muscle diseases.
Claim Rejections - 35 USC § 112
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 1-6 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 1 is indefinite in that it recites a “method for preventing or treating a muscle disease in a subject in need thereof, administration oxiracetam . . . . “ Method claim 1 is missing a transition term such as “comprising” administering of oxiracetam to a claimed subject in need. Method claim 1 requires it “comprises” or “consists of” an active step of “administering” oxiracetam to the subject in need. As presently recited, the claim is indefinite. Dependent claims 2-5 are rejected for depending upon rejected claim 1.
Claims 6 and 8 are indefinite in that they recite a “method for supplying a diet for improving or preventing a muscle disease, comprising oxiracetam. . . .” The claims are unclear as to whether the method is comprising the “administration of” oxiracetam to the subject in need, or whether the diet supplied comprises oxiracetam, where such method is comprising administering a diet to the subject in need. Dependent claims 7 and 9 are rejected for depending upon rejected claims 6 and 8.
Claim Rejections - 35 USC § 112 (4th paragraph)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 depends from claim 1. Claim 2 fails to properly limit claim 1 as claim 2 merely recites chemical formula I,
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which is a known chemical formula structure of oxiracetam. The chemical structural formula recited in claim 2 is merely an equivalent way to identify oxiracetam. It does not further limit the recitation of oxiracetam in claim 1. Note formula I does not provide further limitations with regard to stereochemistry. For example, it neither limits claim 2 to the (R)-oxiracetam or (S)-oxiracetam rotational isomers.
Applicant may cancel claim 2, amend the claim to place it in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim 2 complies with the statutory requirements.
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 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2014181101A1 (WO 101). WO 101 is cited on the IDS dated May 16 2025 as For. Ref. No 1.
Note this anticipation rejection is directed solely to the prevention aspect of the claimed invention.
Claims 1-2 are directed to a method of preventing a muscle disease in a subject in need thereof, interpreted to be comprising the administration of oxiracetam (pharmaceutically acceptable salt or hydrate) as an active ingredient.
Note that all subjects are in need of the prevention of a muscle disease, therefore, prior art teaching the administration of oxiracetam to a subject, will inherently prevent any species of muscle disease (including elected species senile sarcopenia and rejoined species myoclonus) in the treated subject in need. Therefore the teaching of the administration of oxiracetam to a subject would inherently prevent any muscle disease in a subject.
Regarding claims 1-2, WO 101 teaches treatment of a muscle disease, myoclonus, with the nootropic compound, oxiracetam. See page 6, bottom. A method of treating myoclonus would inherently necessitate the administration of oxiracetam to a subject, which would inherently prevent any muscle disease in a subject.
Regarding claims 3-4 and the various species of muscle diseases, these species would be inherently prevented by the administration of oxiracetam to a subject, where page 6 teaches of WO 101 teaches treatment of myoclonus with oxiracetam, where such treatment would inherently entail administration and therefore prevention of muscle diseases in a subject in need.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2014181101A1. WO 101 is cited on the May 16 2025 IDS as For Ref. 1.
Note this rejection is based solely on the aspect of anticipation of the treatment of the muscle disease, myoclonus. Regarding claims 1-2, WO 101 teaches treatment of a muscle disease, myoclonus, with the nootropic compound, oxiracetam. See page 6, bottom.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Wan Ii et al. (S)-Oxiracetam is the Active Ingredient in Oxiracetam that Alleviates the Cognitive Impairment Induced by Chronic Cerebral Hypoperfusion in Rats Scientific Reports | 7: 10052 Published Online 30 Aug 2017 in view of Perna et al. Evidence-Based Role of Nutrients and Antioxidants for Chronic Pain Management in Musculoskeletal Frailty and Sarcopenia in Aging Geriatrics March 2020, 5(1), 16. Both Wan Ii and Perna are cited on the PTO-892 form.
Regarding claims 1-3 (where claim 3 lists elected species senile sarcopenia), Wan li teaches Oxiracetam, is a cyclic derivative of γ-aminobutyric acid (GABA) that belongs to the racetam group. See page 2, paragraph 2. Wan Ii teaches that a particular optical isomer, (S)-oxiracetam is pharmacologically active. See title and abstract.
It is noted that Wan Ii does not teach the treatment of senile (aging) sarcopenia, aka muscle weakness/dystrophy/frailty associated with aging. However, a person having ordinary skill in the art (PHOSITA) would treat senile sarcopenia with oxiracetam, a known GABA derivative. Perna teaches that with regard to chronic pain management in senile sarcopenia (aka musculoskeletal frailty and sarcopenia in aging), GABA, researchers have identified that nutritional components can improve diseases related persistent pain by antioxidant and anti-inflammatory activity, where gamma-aminobutyric acid (GABA) appears to be one of three primary neurotransmitters and pain modulators that are synthesized from amino acids derived from proper nutrition. See Section 3.2, first paragraph page 3 of 12.
Prior to the filing of the present patent application, it would have been prima facie obvious to a PHOSITA following the teachings of Wan Ii to look towards oxiracetam as a GABA derivative, where Perna teaches GABA is known as neurotransmitter and pain modulator in the clinical setting of pain management as associated with sarcopenia associated with aging. See title; abstract and section 3.2.
The PHOSITA would have had a reasonable expectation of success because Wan Ii teaches oxiracetam as a GABA derivative and Perna teaches that GABA is known to control pain in the context of sarcopenia in aging.
Regarding claim 5 and intravenous administration of oxiracetam, Wan Ii teaches where (S)-oxiracetam was diluted with 0.09% sodium chloride solution and administered by IV. See Material and Methods section, Drug preparation and administration, page 10.
Regarding claim 6, a method of diet supply to treat or prevent a muscle disease (senior sarcopenia as per claim 7) comprising oxiracetam as an active, the combination of Wan Ii and Perna teaches the administration of GABA derivative, oxiracetam for alleviation of pain in sarcopenia associated with aging. See above. Note with regard to supplying a diet, Perna teaches how nutritional components in the form of amino acids, are used to synthesize GABA, which in turn, is noted to be a pain modulator in a subject. See Section 3.2.
Regarding claims 8-9 directed to a method for supplying a diet to improve muscle function, as detailed above, Wan Ii and Perna teach the treatment of pain in senile sarcopenia as detailed above. Note that a PHOSITA would predictably arrive at improving muscle function, such as muscle strengthening in a subject, where the alleviation of muscle pain in sarcopenia (senile) associated with aging would predictably result in muscle strengthening of the subject upon the relief of muscle pain.
Conclusion and Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
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, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 CONTINUING DATA
This application is a 371 of PCT/KR2022/005916 04/26/2022
FOREIGN APPLICATIONS
KOREA, REPUBLIC OF 10-2021-0053617 04/26/2021
KOREA, REPUBLIC OF 10-2021-0086607 07/01/2021
KOREA, REPUBLIC OF 10-2021-0146501 10/29/2021
2 CAS Registry Number: 62613-82-5;4-Hydroxy-2-oxo-1-pyrrolidineacetamide (ACI); 2-(4-Hydroxy-2-oxopyrrolidin-1-yl)acetamide; 4-Hydroxypyrrolidone-2-acetamide; CGP 21690; CGP 21690E; CT 848;
Hydroxy piracetam; ISF 2522; Neuractiv; Neuromet; Oxiracetam;Oxyracetam
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