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
Applicant's election with traverse of Group I, Claims 1-7 and 13-16; depression for Species A and C; and anti-depressant medications for species B and D in the reply filed on 3 September 2025 is acknowledged. The traversal is on the grounds that there is no undue burden to search the prior art. This is not found persuasive because the restriction and species election were not made on the basis of an undue search burden and was instead made due a lack of unity of invention for the reasons of record as disclosed in the restriction and species election requirement dated 17 July 2025.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-11, 13-16, 18-20, 23, and 25 are pending. Claims 12, 17, 21-22, and 26 are canceled. Claims 1, 2, 7-11, 18-20, 23, and 25 are amended. Claims 8-11, 18-20, 23, and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3 September 2025.
Claims 1-7 and 13-16 are being examined on the merits.
Claim Rejections - 35 USC § 112(a)
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 1-7 and 13-16 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 a method for increasing swimming time in mice comprising administration of an effective amount of Crassocephalum rabens plant or extract thereof wherein administration increases skeletal muscle lactate dehydrogenase or malate dehydrogenase in male mice, does not reasonably provide enablement for a method for preventing or treating all muscle fatigue in any subject comprising administration of an effective amount of Crassocephalum rabens plant or extract thereof wherein administration increases skeletal muscle lactate dehydrogenase or malate dehydrogenase. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to administer the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method for preventing or treating muscle fatigue in a subject in need thereof comprising administration of an effective amount of Crassocephalum rabens plant, extract, of galactolipids thereof wherein the method is for increasing skeletal muscle lactate dehydrogenase or malate dehydrogenase. The claims imply that any muscle fatigue associated with depression and/or antidepressant medications can be prevented or treated using any part of the C. rabens plant, any extract from any part of the plant using any solvent, or any galactolipid thereof.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
Crassocephalum sp. (e.g., C. crepidioides, C. rubens, and C. rabens of instant Claim 2) is known in the art as an ethnobotanically important plant, found in tropical and sub-tropical regions, that has nutraceutical, antibiotic, anti-inflammatory, anti-helminthic, anti-diabetic, and anti-malarial properties (Karmakar et al., Introduction, page 296). Crassocephalum crepidioides methanolic extract inhibits nitric oxide, prostaglandin E2, TNF-α, IL-6, and IL-1β production, increases splenocyte proliferation, inhibits Candida albicans proliferation, and increases IgA and IgM levels (Karmakar et al., Figures 3-7).
Galactolipid-rich extracts of C. rabens, including dLGG, are known in the art for preventing or treating sepsis, acute fulminant hepatitis, acute kidney injury induced by sepsis, and skin whitening (US 2014/0356301 A1, Claims 1 and 15-21). Additionally, a method of treating breast cancer or breast cancer metastasis comprising administration of C. rabens extract to a subject in need thereof is also known in the art (WO 2019/147300 A1, Claim 1). The extract comprises dLGG or DGDG and can additionally attenuate side effects such as fatigue (WO 2019/147300 A1, Claims 4, 9, and 10). The effective amount of the composition may be determined using routine experimentation depending upon the specific therapeutic situation (WO 2019/147300 A1, [0039]), however experimental doses included low and high doses given to mice, ranging from 5-25 mg/kg daily (WO 2019/147300 A1, [0084]).
Since a method for preventing or treating muscle fatigue comprising administration of C. rabens wherein the method is for increasing skeletal muscle lactate dehydrogenase or malate dehydrogenase remains largely unsolved, means for determining how to carry out this method is highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high, with respect to administration of ethnobotanically important plants in general. However, treating depression-related muscle fatigue using C. rabens remained unresolved as evidenced by the prior art discussed above and beyond the purview of one of skill. Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided evidence that administration of C. rabens plant material and extracts increases the swimming time in male and female mice (see e.g., Figure 3A-B, Figure 5). It is also indicated that LDH and MDH activity is increased in male mice (Figures 6 and 8), however in female mice LDH and MDH activity was decreased with administration of C. rabens plant material. It is noted that female mice were only included in Program I where the mice were fed C. rabens plant powder as a feed additive at a dose of 0.6% and 1.2%. In Program II, where mice were fed doses of C. rabens extract ranging from 150-600 mg/kg of body weight ([0069]), only males were included ([0081]). The specification, however, does not provide any sort of discussion or explanation for this difference in proposed mechanism of action (e.g., a method which increases LDH or MDH).
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Karmakar et al., US 2014/0356301 A1, and WO 2019/147300 A1 and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to determine an effective dose or method for treating or preventing depression-associated muscle fatigue in a subject in need thereof (comprising both males and females) wherein LDH or MDH are increased.
It is the Examiner’s position that one skilled in the art could not practice the invention commensurate in the scope of the claims without undue experimentation. It is also noted, considering the a priori unpredictability in the art with regard to efficacy and dosing for prevention or treatment of muscle fatigue in any subject comprising administration of C. rabens, that the claimed prevention and/or treatment is not enabled.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under 35 U.S.C. § 112(a) for the reasons set forth above.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 and 13-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.
Additionally, regarding Claim 1, “increasing skeletal muscle lactate dehydrogenase and/or malate dehydrogenase” is indefinite because it is unclear what is meant by “increasing.” Does this reference an increase in enzyme activity, an increase in enzyme production, both, or is it referencing something else? Appropriate clarification is necessary.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under 35 U.S.C. § 112(b) for the reasons set forth above.
Conclusion
No claims are allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655