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 .
Acknowledgement is made to Applicant’s response filed 01/20/2026.
Claims 9 and 11-13 are pending and are currently under consideration.
Claims 9 and 11 are currently amended.
Claims 1-8 and 10 remain cancelled.
Withdrawn Rejections
The rejection of claim(s) 9 and 11-13 under 35 U.S.C. 102(a)(1) as being anticipated by Kim (US 2006/0193929) as evidenced by Renew (2015) is withdrawn in view of Applicant’s amendment to the method of claim 9 requiring the patient to be suffering from exercise-induced fatigue.
New Grounds of Rejection – Necessitated by Applicant’s Amendments
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(s) 9 and 11-13 (all claims currently under consideration) is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (US 2006/0193929) as evidenced by Lurati (2017).
Kim teaches a composition comprising an extract from Cynanchum Wilfordii, and extract from Phlomis umbrosa, and an extract from Angelica gigas (see entire document, for instance, Abstract). The extracts are taught as being able to be obtained by water or C1-4 alcohol extraction (see entire document, for instance, [0039]). The composition is taught as being useful for treating menopause symptoms, such as fatigue (see entire document, for instance, [0067]). Lurati evidences that menopause fatigue includes exercise intolerance and results in early fatigue thresholds (see Lurati, entire document, for instance, page 1, section titled Exercise Intolerance and Mitochondrial Dysfunction). It is noted that menopausal fatigue includes the exercise intolerance and physiological fatigue articulated in Lurati.
It is noted that Kim teaches the instantly claimed method steps, and therefore, the claimed results of said method, such as increasing intramuscular glycogen levels, decreasing serum lactate dehydrogenase levels, increasing at least two enzyme activities, and increasing expression of PPAR-γ and UCP-3 in muscle tissue would necessarily occur as a result of said method steps. It is also noted that the only active method step required is administration to a subject a composition comprising an extract of at least one from the listed group in claim 9.
Response to Arguments
As an initial matter, it is noted that Applicant predicates some of their remarks on a website and NPL documents which were not cited on an IDS, and as such, said materials are not being considered. Applicant argues in the Remarks filed 09/30/2025 that the prior art does not teach the same type of fatigue as is instantly claimed. Applicant’s argument is not found persuasive. Specifically, while the preamble of the instant claims are drawn to treatment or recover of certain types of fatigue, the active method steps are drawn to administering a composition to an undefined patient population. Further, it is noted that treatment of a fatigue would include treating any symptom or effect of said fatigue, wherein symptoms such as tiredness is a common symptom among fatigues. As such, treatment of a fatigue, such as menopausal fatigue, which includes the treatment of tiredness (as is seen in Renew) would result in treatment of a symptom of other fatigues as well. As the patient population is the same, and the method step being followed is the same, the prior art anticipates the instant claims. It is the opinion of the Examiner that the recitation of the effects of the method in claims 9 and 13 does not distinguish the claimed method over Kim because merely recognizing that effects of the method does not change how the process is performed. The only difference is that applicants have recognized an inherent result of an old process which was not known before. Additionally, merely discovering and claiming a new benefit of an old process cannot render the process again patentable. Verdegaal Bros., Inc. v. Union Oil Co. of Calif., 814 F.2d 628, 632-33, 2USPQ2d 1051, 1054 (Fed. Cir.), cert. Denied, 484 U.S. 827 (1987). As in Verdegaal Bros., Inc. v. Union Oil Co. of Calif., 814 F.2d 628, 632-33, 2USPQ2d 1051, 1054 (Fed. Cir.), cert. Denied, 484 U.S. 827 (1987), the burden of proof in the present case is limited to establishing that Kim disclose the same process. The examiner does not have the additional burden of proving that Kim recognized effects of the process, that property was inherently possessed by the active steps in the disclosed process, and, thus Kim’s process anticipates the claimed invention.
Therefore, for the reasons articulated herein as well as the reasons of record, Applicant’s arguments are not found persuasive.
Response to Arguments
Applicant’s remarks directed to the 102 rejection have been fully considered and are not found persuasive against the ground of rejection set forth above. Specifically, Applicant argues that the prior art does not teach that the patient is experiencing exercise-induced fatigue. It is noted that the evidentiary reference establishes that the genus of menopausal fatigue includes exercise-induced fatigue. Therefore, Applicant’s arguments are not persuasive against the ground of rejection.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 9 and 11-13 (all claims currently under consideration) is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US 2006/0193929) and Lurati (2017).
Kim teaches a composition comprising an extract from Cynanchum Wilfordii, and extract from Phlomis umbrosa, and an extract from Angelica gigas (see entire document, for instance, Abstract). The extracts are taught as being able to be obtained by water or C1-4 alcohol extraction (see entire document, for instance, [0039]). The composition is taught as being useful for treating menopause symptoms, such as fatigue (see entire document, for instance, [0067]).
Kim, while teaching all of the instantly claimed method steps, and teaching that the patient has menopausal associated fatigue, does not expressly state that the patient is suffering from exercise-induced fatigue.
Lurati teaches that menopause fatigue includes exercise intolerance and results in early fatigue thresholds (see Lurati, entire document, for instance, page 1, section titled Exercise Intolerance and Mitochondrial Dysfunction). It is noted that menopausal fatigue includes the exercise intolerance and physiological fatigue articulated in Lurati.
It would have been obvious to one of ordinary skill in the art, experiencing exercise-induced fatigue as articulated in Lurati, to utilize the method of Kim to treat said fatigue. One would have been motivated to do so since Kim teaches that the method of Kim is useful for treating menopausal fatigue, wherein Lurati teaches that menopausal fatigue includes exercise intolerance and results in early fatigue thresholds. There would be a reasonable expectation of success since both Kim and Lurati are directed to menopausal patients.
It is noted that Kim teaches the instantly claimed method steps, and therefore, the claimed results of said method, such as increasing intramuscular glycogen levels, decreasing serum lactate dehydrogenase levels, increasing at least two enzyme activities, and increasing expression of PPAR-γ and UCP-3 in muscle tissue would necessarily occur as a result of said method steps. It is also noted that the only active method step required is administration to a subject a composition comprising an extract of at least one from the listed group in claim 9.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 TREVOR M LOVE whose telephone number is (571)270-5259. The examiner can normally be reached M-F typically 6:30-3.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 5712726175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR LOVE/Primary Examiner, Art Unit 1611