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 .
This office action is in response to the amendment filed on June 16, 2026. Claims 7-13 have been withdrawn in the office action mailed on March 25, 2026. Claims 1-6 are currently pending and are under examination.
Claim Objections
Claim 2 is objected to because of the following informalities:
In claim 2, the term “muscular dystrophy” is duplicated. Applicant is reminded that one term of “muscular dystrophy” is sufficient.
Appropriate correction is required.
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) 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jeong Hee (KR 20140000627 A – English translation provided).
Regarding claim(s) 1-6, the Jeong Hee reference teaches a composition that contains [(i.e. comprises]) the extract of Poncirus trifoliata ([e.g. Ponciri Fructus]) (abstract and claim 6). Jeong Hee teaches an immature fruit of Korean fruit (Poncirus trifoliate) (claim 5). Jeong Hee teaches the fruit ([e.g. Poncirus trifoliata]) is extracted with ethanol (page 4, 'Experimental example 2-4'). Jeong Hee teaches treating myotonic dystrophy ([a type of muscular dystrophy]) (page 2, under 'Background Art' and claim 7).
The reference does not specifically teach that administering the composition has the same effects on gene expression as claimed by applicant in claim(s) 3 and 4 of the present invention. However, the ingestion of the extract would inherently increase the expression of the genes listed within claim(s) 3 (Myf5, Myf6, Myod, and/or Myog) and 4 (Ppard or Pgc1a).
Response to Arguments
Applicant’s arguments filed June 16, 2026 have been fully considered, and the arguments regarding the rejection under 35 U.S.C. § 102 for anticipation is found to be non-persuasive for claim(s) 1-6.
Regarding applicant’s remarks for the 35 U.S.C. § 102 rejection, beginning on page 5 of applicant arguments, applicant states “Jeong, by contrast, discloses a medicinal herb composition for improving, treating, and preventing gastrointestinal motility disorders. The composition of Jeong is a combination of Zanthoxylum (Sancho) and Poncirus trifoliata (Jisil/Ponciri Fructus) extracts, specifically formulated to treat postoperative ileus, irritable bowel disease, functional dyspepsia, vomiting, and related gastrointestinal dysfunctions…[and that] Jeong contains no disclosure, teaching, or suggestion of: (a) any use of Ponciri Fructus extract for the prevention or treatment of a muscle disease; (b) any muscle disease, sarcopenia, muscular dystrophy, or related skeletal muscle condition; or (c) any effect on myotube differentiation or muscle physiology. The claimed indication – a therapeutic application for muscle disease – is entirely absent from Jeong”. Moving towards page 6 of applicant arguments, applicant states that “this language makes clear that myotonic dystrophy is recited in Jeong solely as one of several possible underlying causes (etiology) of gastrointestinal dysfunction – not as a disease being treated. The treatment of Jeong remains, in every instance, the gastrointestinal motility disorder itself…[in addition] a composition directed to alleviate the gastrointestinal consequences of myotonic dystrophy is not thereby a composition for treating myotonic dystrophy as a muscle disease”. Moreover, towards the bottom of page 6 of applicant arguments and going into pages 7-8 of applicant arguments, applicant further discusses the differences in composition between the Jeong Hee reference and the claimed invention, discusses that the therapeutic application for muscle disease is a novel discovery as a result of “no reports of Ponciri Fructus extract being used for the treatment of muscle disease or sarcopenia, and no reports of any effect on myotube differentiation or muscle-related gene expression” and that lastly examiners “inherency theory is legally insufficient…the examiner has not provided any evidence, experimental data, or scientific reasoning to establish that the gastrointestinal composition of Jeong Hee would necessarily upregulate any of the muscle-specific genes recited in claim(s) 3 and 4”. Going in sequential order of applicant’s arguments, beginning with the information found on page 5 of applicant’s arguments, the Jeong Hee reference uses the term “containing” which is also known to be synonymous with the term “comprising” (see MPEP 2111.03); thus, although Jeong Hee’s composition includes additional components, as a result of how the claims of the present invention are worded, the composition of the present invention can include anything outside of the Ponciri Fructus extract which means that the Jeong Hee reference effectively meets the claim limitations of the present invention due to the open-endedness of the term “containing”. In addition, the Jeong Hee reference does discuss using the Ponciri Fructus extract to treat those who have gastrointestinal dyskinesia due to myotonic dystrophy. Myotonic dystrophy is one of many forms of muscular dystrophy. Although the Jeong Hee reference is targeting gastrointestinal dysfunction, the gastrointestinal dysfunction would have not occurred without the myotonic dystrophy and therefore, the Jeong Hee reference understands this and therefore the administration of the extract that includes the Ponciri Fructus extract would inherently also affect myotonic dystrophy. Based on examiner’s understanding and interpretations, although the method of using the composition is different, the composition in the Jeong Hee reference and the claims of the present invention are still the same; "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty."); see MPEP 2112.01 (II). Thus, regardless of what is included in Jeong Hee’s composition, if the composition does possess the Ponciri Fructus extract, the composition as taught by Jeong Hee would inherently affect gene expression as claimed in claim(s) 3 and 4 of the present invention. Therefore, the inherency theory is legally sufficient because the missing characteristic (i.e. increased expression of Myf5, Myf6, Myod, Myog, Ppard or Pgc1a) is inherently present because the increased expression would happen as a result of ingestion of the Ponciri Fructus extract. The only evidence available to establish that the gastrointestinal dysfunction (that happens as a result of myotonic dystrophy) composition of Jeong Hee would upregulate any of the muscle-specific genes recited in claim(s) 3 and 4 is because the gastrointestinal dysfunction is as a result of a type of muscular dystrophy, fully meeting the claim limitations of the present invention – in other words, as a result of progressive muscle loss or weakness, this issue prompts another issue or domino effect (i.e. gastrointestinal dysfunction) and the only way to regulate this issue is to correct the gastrointestinal dysfunction, which would also intrinsically entail treating the source as well – myotonic dystrophy. Moreover, given that the applicant has provided additional evidence across figures 2, 3, 16 and 17 of the present application of the effects of the Ponciri Fructus extract, that does not overcome the Jeong Hee’s reference because the ingestion of an extract of Ponciri Fructus would inherently cause those effects stated within the specified figures given that the extract of Ponciri Fructus is targeted towards gastrointestinal dystrophy that is caused by myotonic dystrophy, a type of muscle disease under muscular dystrophy – as stated across claim(s) 1-2 of the present invention. Thus, the rejection under 35 U.S.C. § 102 for anticipation for claim(s) 1-6 are maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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