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 .
Election/Restrictions
In the reply filed on June 03, 2026, applicant elected group II, claim(s) 10-15 and the compound of formula 4 (4-ethyl catechol) without traverse. Claim(s) 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim(s) 10-15 are examined on the merits.
Specification
The abstract of the disclosure is objected to because it is not a single paragraph preferably
within the range of 50 to 150 words in length. The abstract of the disclosure is about 41 words. A corrected abstract of the disclosure within the preferred ranges disclosed is
required. See MPEP § 608.01(b).
In addition, throughout the specification, the term “Aralia Elata” should be italicized to read “Aralia Elata”.
Appropriate correction is required.
Claim Objections
Claim(s) 10, 12 and 15 is objected to because of the following informalities:
In claim 12, “increases a grip strength” should read “increases grip strength”
In claim(s) 10 and 15, “Aralia Elata” should be italicized to read “Aralia Elata”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 10-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabled for treating or reducing the occurrence of muscle diseases, does not reasonably provide enablement for prevention of muscle diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and breadth of the claims. In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Applicant’s claims are broadly drawn to a method of using a composition that is capable of preventing a muscle disease. In order to be enabled for prevention of a condition, applicant must demonstrate that the invention is able to prevent the condition in each and every instance of that condition. Applicant’s specification does not set forth any evidence that the claimed product is able to prevent muscle disease for all potential causes of muscle disease. In addition, the state of the art teaches that muscle disease (e.g. muscular dystrophy) prevention is not accepted as possible because a genetic change is what causes the disease (which cannot be controlled) (Please see: https://my.clevelandclinic.org/health/diseases/14128-muscular-dystrophy#prevention – Date accessed: July 16, 2026). Thus, since applicant’s specification does not show prevention of muscle disease and the art acknowledges that prevention is not currently possible, a person of ordinary skill in the art would be forced to experiment unduly in order to determine if applicant’s invention actually function as claimed. Therefore, the claims are not considered enabled for the prevention of muscle disease.
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.
Claim(s) 10-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hou (CN 104784522 A – English translation provided) with Dresser et al (Journal of Clinical Medicine, (Year: 2021), vol. 10, issue. 11, pp. 1-17) providing evidence of inherent characteristics of Hou.
Hou teaches a composition that can include Japanese aralia bark in order to treat myasthenia gravis ([e.g. a muscle disease]) (claim 1). Hou teaches [a water/ethanol extraction method of the Japanese aralia bark] (page 2).
The Hou reference does not explicitly state that the composition is capable of increasing a grip strength (as stated in claim 12 of the present invention), increasing muscle weight (as stated in claim 13 of the present invention), one or more muscles such as thigh muscle, gastrocnemius muscle, calf muscle and soleus muscle (as stated within claim 14 of the present invention) and the presence of compound 4 within the Aralia Elata extract (as stated within claim 15 of the present invention). However, the Hou reference has a composition that would inherently meet the limitations of claim(s) 12 and 13. Moreover, Dresser et al demonstrates that a muscle disease, like myasthenia gravis, is known in the art to affect the limbs, which would also inherently encompass some of the limitations that are present within claim 14 of the present invention. Furthermore, using the specification of the present invention as a source of definition, the specification does state that an extraction using water and/or a solvent from a lower alcohol (e.g. ethanol) is capable of achieving the compounds (e.g. compound 4: 4-ethyl catechol) (paragraphs 0062, 0063 and 0087-0091). Hou’s reference does teach a water/ethanol-based extraction thus meaning that compound 4 (4-ethyl catechol) from claim 15 of the present invention would inherently be present within the A. Elata extract that would be used within Hou’s composition. Overall, claim(s) 10-15 are encompassed by the Hou reference as a result of Hou teaching that they are administering the same composition as stated in the claims of the present invention to the same patient (e.g. a patient that has a muscle disease) in which, that composition has an A. Elata extract that contains the desired compound, 4-ethyl catechol.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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