Patent Application 18008215 - COMPOSITION FOR RECOVERY FROM FATIGUE

Title: COMPOSITION FOR RECOVERY FROM FATIGUE

Application Information

Invention Title: COMPOSITION FOR RECOVERY FROM FATIGUE
Application Number: 18008215
Submission Date: 2025-04-09T00:00:00.000Z
Effective Filing Date: 2022-12-05T00:00:00.000Z
Filing Date: 2022-12-05T00:00:00.000Z
National Class: 424
National Sub-Class: 725000
Examiner Employee Number: 85016
Art Unit: 1611
Tech Center: 1600

Rejection Summary

102 Rejections: 1
103 Rejections: 0

Cited Patents

The following patents were cited in the rejection:

US 0193929🔗

Office Action Text

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 preliminary amendment filed 12/05/2022.
Claims 9-12 are pending and are currently under consideration.
Claims 1-8 are cancelled.

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 9-12 (all claims currently under consideration) are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of fatigue and recovery from fatigue, does not reasonably provide enablement for the prevention of fatigue. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 11, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CAFC 1988).
Wands states on page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”

The nature of the invention is treating, recovering from, or preventing fatigue, where the relative level of skill of those in the art is deemed to be high.
The claims are broadly drawn to a method of treating, recovering from, or preventing fatigue by administering a composition comprising Cynanchi Wilfordii Radix, Phlomis umbrosa, or angelica.
The specification teaches only that the active can be utilized to treat and assist in recovery of fatigue. There are no working examples of the composition effectively preventing all forms of fatigue. Thus, the scope of the claims is extremely broad compared to the guidance and exemplification provided in the specification. The scope of the claims must bear a reasonable correlation with the scope of enablement. See In re Fisher, 166 USPQ 1924 (CCPA 1970).
The state of the prior art is such that it is well established in the art that prevention of a disorder requires significant research, testing, and trial-and-error in order to arrive at prevention. The state of the art recognizes that it would be highly unpredictable. One of ordinary skill in the art could not predictably extrapolate the teachings in the specification to know how to completely prevent fatigue. With respect to the broad scope of "preventing”, the specification discloses various other methods, such as treating and assisting in recovery, however, the specification does not provide sufficient guidance or direction as to the general prevention of fatigue. The specification does not enable the genus because where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one particular species, what other species will work. See MPEP 2164.03. One of skill in the art would neither expect nor predict the appropriate functioning of the active to prevent as is claimed.
In view of the lack of predictability of the art to which the invention pertains, the lack of guidance and direction provided by Applicant, and the absence of working examples, undue experimentation would be required to practice the claimed method with a reasonable expectation of success, absent specific and detailed description in Applicant's specification of how to effectively practice the claimed method and absent working examples providing evidence which is reasonably predictive that the claimed method would prevent fatigue commensurate in scope with the claimed invention.

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) 9-12 (all claims currently under consideration) is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (US 2006/0193929).
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 sleep disorders, joint pain, and fatigue (see entire document, for instance, [0067]).

Conclusion
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 on 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