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 .
Response to Amendment
Applicant's amendment and argument filed 11/16/2025, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-6 are being examined on the merits.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoon Yoo-Sik et. al. (CN112040965A). This rejection is maintained due to the arguments filed on 11/16/2025.
Regarding claim 1, Yoo-Sik discloses composition comprising an extract of Paeonia suffruticosa root as an active ingredient, which alleviates anorexia, weight loss, muscle loss and fatigue and suppresses hematopoietic toxicity, and thus can be effectively used for preventing, reducing or treating cachexia and muscle loss (see abstract, first page and page 5, after figures). Yoo-Sik discloses administration to subjects wherein the cachexia is from cancer patients (see page 5, after figures). It can be appreciated that the Paeonia suffruticosa root extract is the same as the Moutan radicis cort extract as being claimed as discussed in the applicant’s response (see response filed on 06/24/2025, page 1-2).
Yoo discloses verbatim: “A composition comprising Paeonia suffruticosa root extract as an active ingredient reduces appetite, weight loss, muscle loss, fatigue and hematopoietic suffruticosa toxicity.
Therefore, the composition can be effectively used to prevent, alleviate or treat cachexia and muscle loss” (see page 3, Summary of the invention, para 12-13).
“According to one embodiment of the present disclosure, Paeonia suffruticosa root extract can alleviate symptoms selected from the group consisting suffruticosa of inappetence,
weight loss, fatigue, inflammation, muscle loss and hematopoietic toxicity, and thus can be effectively used for alleviating, preventing or treating cachexia and muscle loss” (see page 4, detailed ways, para. 9). Further see page 6, page 7, page 16 which all disclose Paeonia suffruticosa.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon Yoo-Sik et. al. (CN112040965A). This rejection is maintained due to the arguments filed on 11/16/2025.
Yoo-Sik discloses composition comprising an extract of Paeonia suffruticosa root as an active ingredient, which alleviates anorexia, weight loss, muscle loss and fatigue and suppresses hematopoietic toxicity, and thus can be effectively used for preventing, reducing or treating cachexia and muscle loss (see abstract, first page and page 5, after figures). Yoo-Sik discloses administration to subjects wherein the cachexia is from cancer patients (see page 5, after figures). It can be appreciated that the Paeonia suffruticosa root extract is the same as the Moutan radicis cort extract as being claimed as discussed in the applicant’s response (see response filed on 06/24/2025, page 1-2).
Yoo-Sik teaches extracting with 30% ethanol (see example 1).
Yoo-Sik does not specifically teach the methanol/ethanol solvent to be at 50% to 100% or at 70%, or specifically that the method is for cancer-induced skeletal muscle loss, or that the specific muscle genes are upregulated/downregulated, however Yoo-Sik teaches the same root of the same species of plant is extracted with ethanol and teaches the same general activity which pertains to cancer-induced cachexia muscle loss.
It would have been obvious to persons having skill in the art before the effective filing date to optimize the percentage of ethanol solvent to be at the amount being claimed because persons of skill would want to find the greatest activity with the least amount of side effects and optimizing the percent of alcohol solvent used during extraction would help to find which percentage draws out the most soluble aqueous-alcohol soluble compounds. Additionally, given the prior art it is well within the purview of any skilled artisan to optimize solvent concentrations during extractions. It would have also been obvious to use the method for cancer-induced skeletal muscle weight loss because Yoo-Sik teaches the composition is for cancer-induced muscle loss and so using it for a specific type of muscle would have been prima facie obvious given that the relied upon art is not so restrictive.
Response to Arguments
Applicant's arguments filed 11/16/2025 have been fully considered but they are not persuasive. The applicant argues that the relied upon art does not teach the limitation that the composition is indeed Moutan radicis cort or an extract of Moutan radicis cort, because the applicant argues that Yoo only teaches a composition which is comprising Paeoniae radix from P. lactiflora. Yoo indeed teaches the same species being Paeonia suffruticosa as being argued. The applicant is ignoring the arguments made by the Office and instead is only relying on one portion of Yoo’s teaching which is directed to paragraph 0040. Yoo discloses verbatim: “A composition comprising Paeonia suffruticosa root extract as an active ingredient reduces appetite, weight loss, muscle loss, fatigue and hematopoietic suffruticosa toxicity.
Therefore, the composition can be effectively used to prevent, alleviate or treat cachexia and muscle loss” (see page 3, Summary of the invention, para 12-13)
“According to one embodiment of the present disclosure, Paeonia suffruticosa root extract can alleviate symptoms selected from the group consisting suffruticosa of inappetence,
weight loss, fatigue, inflammation, muscle loss and hematopoietic toxicity, and thus can be effectively used for alleviating, preventing or treating cachexia and muscle loss” (see page 4, detailed ways, para. 9). Further see page 6, page 7, page 16 which all disclose Paeonia suffruticosa.
The declaration under 37 CFR 1.132 filed 11/16/2025 is insufficient to overcome the rejection of claims 1-6 based upon the 102(a)(1) and 103 rejections as set forth in the last Office action because: Yoo teaches the species which is being argued and claimed by the applicant as can be appreciated from the above rejections and arguments.
The applicant also argues components which are not being claimed. For instance the applicant argues that the current invention has 140 times higher active ingredient of paeonol than what would be found in the species P. lactiflora.
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 JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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