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 .
Detailed Action
Response to Amendments
The amendments made to the claims and specification 07/22/2026 have been entered.
In view of the amendments made, the 102, 102/103, double patenting rejections have been withdrawn.
In view of the amendments, certain 112(b) rejections made over claims 1, 4-7 and 11 are hereby withdrawn. The specific rejections withdrawn are the rejection over the use of “(substituted)”, “and a derivative or analogue thereof”, and the use of the CAS trademark. See new objection below.
In view of the amendments, the objection made over claim 1 is withdrawn.
Restriction/Species Election
New claim 34 is drawn to an identical method to that of claim 1 except that compounds “wherein…R2, R4, and R5 are…C1 to C20 alkyl…” are excluded. Therefore, claim 34 is independent and distinct from claim 34.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 34 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Additionally, as claim 11 has been amended to depend from claim 34, it is also withdrawn. The antecedent rejection made over claim 11 is hereby withdrawn.
Note: Applicant states in the remarks submitted 07/22/2026 that claim 11 has been amended to depend from claim 34 to overcome the antecedent basis rejection (p. 23 of the remarks). The rejection is withdrawn as the parent claim is withdrawn and technically not under examination. However, the antecedent basis issue is still present. Upon rejoinder of claim 34, claim 11 will be rejected for lacking antecedent basis.
Maintained Rejections
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.
Written Description
Claims 1, 4-7, 11, and 30-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 states “A method for (i) improving a physiological state linked to metabolic fatigue in one or more cells, (ii) increasing mitochondrial energy in one or more cells, (iii) increasing antioxidant capacity, reducing oxidative stress and/or enhancing mitochondrial function, (iv) improving mobility and/or (v) improving healthspan and/or lifespan in an individual comprising administering…”.
The instant application discloses working examples starting on p. 42. Example 1 is drawn to measuring thermotolerance of C. elegans. Example 2 is drawn to increasing lifespan in an AMPK-dependent manner. Example 3 states that the percentage of highly active C. elegans increases after administration of CBDA. This is repeated in example 5. The last example, example 6 shows that autophagy is increased in zebrafish larva after administration of CBDA.
While the claimed methods in claim 1 are indefinite (See 112(b) rejection below), the specification discloses working examples of increasing the lifespan, increasing thermotolerance, and increasing mobility. However, no examples of the other terms (i, ii, iii) have been shown within the specification. Because of the indefiniteness of the claim, it is not clear where “increasing thermotolerance” falls within the terms i-v above.
One of ordinary skill in the art would not find the instant disclosure sufficient to indicate the applicant has possession of the full scope of claim 1.
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.
Indefiniteness
Claims 1, 4-7, 11, and 30-33 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.
Claim 1 states “A method for (i) improving a physiological state linked to metabolic fatigue in one or more cells, (ii) increasing mitochondrial energy in one or more cells, (iii) increasing antioxidant capacity, reducing oxidative stress and/or enhancing mitochondrial function, (iv) improving mobility and/or (v) improving healthspan and/or lifespan in an individual comprising administering…”.
None of these terms and limitation are explicitly defined within the specification. For example, the terms “physiological state or disorder related to cell ageing” and “physiological state linked to metabolic fatigue” are not explicitly defined and there are no listings in the claims or specification that indicate what “physiological state” or “disorder” are claimed.
Regarding the terms “increasing mitochondrial energy”, “increasing antioxidant capacity, reducing oxidative stress and/or enhancing mitochondrial function”, these terms are not explicitly defined and, additionally, the specification does not disclose methods to measure these effects or how they are typically measured within the art. Therefore, the claims are indefinite.
Claims 30-33 have been included in these rejections as applicant as amended the claims to include these new claims.
Response to Arguments
Regarding the 112(a) rejection, applicant states that the specification provides support for I, ii, iii, iv, and v on p. 11, l. 13-26 and on p. 39, l. 20 to p. 41, l. 30.
The specification on p. 11, l. 13-26 simply states the following:
“An additional advantage of one or more embodiments provided by the present disclosure is protect an ageing individual from muscle dysfunction, for example sarcopenia, frailty, inclusion body myositis, myopathy/myolysis induced by drugs such as corticosteroids or statins, muscle wasting induced by immobilization or hospitalization.
An additional advantage of one or more embodiments provided by the present disclosure is to protect an ageing individual from muscle weakness.
Still another advantage of one or more embodiments provided by the present disclosure is to increase the survivability of a critically ill patient or an ageing individual”.
An additional advantage of one or more embodiments provided by the present disclosure is to accelerate the regain of mobility, or shorten the time of immobility, after discharge from the intensive care unit.”
The specification starting on p. 39, l. 30 discusses mitochondrial diseases, improving healthspan and/or lifespan, stress and stress types, and delaying off-set of metabolic decline. Examiner notes that “delaying off-set of metabolic decline” is subject matter in withdrawn claim 2.
The MPEP section 2163(I) states:
An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by “whatever characteristics sufficiently distinguish it”). “Compliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’” Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1612. An application specification may show actual reduction to practice by describing testing of the claimed invention…”
Subsection A states:
“An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function… Written description issues may also arise if the knowledge and level of skill in the art would not have permitted the ordinary artisan to immediately envisage the claimed product arising from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996)”.
The applicant has not shown how the above embodiments can be achieved via administration of CBDA or how this would have been clear to one of ordinary skill in the art from the working examples. As stated in the rejection above, the working examples are drawn to measuring thermotolerance of C. elegans, increasing lifespan in an AMPK-dependent manner, increasing the percentage of highly active C. elegans increases after administration of CBDA, and increasing autophagy in zebrafish larva after administration of CBDA. The excerpt above and the discussion on p. 39-p. 41 is merely contemplative. There are no examples of testing the effects of CBDA on animals more complex than zebrafish and it is not clear how one of ordinary skill in the art would be able to determine that the effects seen in testing with zebrafish would predictably lead to the effects contemplated.
Essentially, applicant has shown the effects of administration of CBDA to zebrafish under certain conditions, but has not shown how these effects are related to “muscle dysfunction, frailty, inclusion body myositis, myopathy/myolysis induced by drugs such as corticosteroids or statins, muscle wasting induced by immobilization or hospitalization” and/or to what is claimed which includes “improving a physiological state linked to metabolic fatigue”, “increasing mitochondrial energy”, “increasing antioxidant capacity”, “reducing oxidative stress and/or enhancing mitochondrial function”, “improving mobility”, and “improving healthspan and/or lifespan”.
Regarding the 112(b) rejection, applicant argues that support for “physiological state linked to metabolic fatigue” is found on p. 39, l. 20-21, methods of measuring “increasing mitochondrial energy in one or more cells” is found in U.S. Patent publication No. 2021/0267251, and methods to measure antioxidant capacity or protection against oxidative stress is found within U.S. patent publication No. 2013/0287740.
The excerpt that applicant points to states “In another embodiment, metabolic fatigue comprises lack of energy, in particular physical energy, lack of vitality or weakness.” This is an exemplary listing and also does not include “physiological states”, as claimed. Additionally, this listing is even more ambiguous as the claims do not indicate which physiological states would be associated with “lack of vitality or weakness.” As an example, Lou Gehrig’s disease is a motor neuron condition characterized by muscle loss and weakness. However, there is a distinct difference between suffering from Lou Gehrig’s disease and lacking “physical energy”. One of ordinary skill in the art would not immediately know the meaning of “physiological states associated with metabolic fatigue” from what the specification states.
Cuenoud (US20210267251) is drawn to “compositions and methods using a nicotinamide adenine (nad+) precursor and at least one ketone or ketone precursor (title). Cuenoud in para. [0104] does teach a method of measuring mitochondrial respiration via measuring oxygen consumption. However, this teaching further emphasizes applicant’s lack of possession of the instant invention as this method is not used or disclosed within the instant specification and/or the method in Cuenoud para. [0104] has not been practiced with cannabidiolic acid.
Hannah (US 9,322,832) is drawn to a method of diagnosing degenerative joint disease. Hannah in col. 1, sec. Description of Related Art states “U.S. Pat. No. 7,005,274 discloses diagnostic methods for early detection of a risk for developing an arthritic disorder in humans and screening assays for therapeutic agents useful in the treatment of arthritic disorders by comparing the levels of one or more indicators of altered mitochondrial function, e.g., enzymes such as mitochondrial enzymes, ATP biosynthesis factors, mitochondrial mass, mitochondrial number, mitochondrial DNA content, cellular response to elevated intracellular calcium and to apoptogens, and free radical production.” However, Hannah concludes in Col. 8, sec. Statistical Analysis “Student T tests was performed with an analysis software package “R”…on all data generated I this study. Statistically significant differences between two groups were investigated for individual saliva biomarkers. The results are shown in Table 1 and Table 2 Referring to Table 1 and Table 2, the data show that IFNγ, IP-10, IL-2, and total saliva protein are significantly different between animals with and animals without degenerative joint disease.” At best, Hannah provides a method of measuring mitochondrial function, but does not define “increasing mitochondrial energy” and even further, emphasizes applicant’s lack of the invention as Hannah does not teach any assays wherein CBDA has been administered.
Bel-Rhild (US20130287740) in para. [0003]-[0004] discusses the effects of coffee and coffee active compounds such as caffeine and diterpenes. Bel-Rhild specifically states “Coffee and coffee active compounds such as caffeine and diterpenes have been shown to induce detoxifying enzymes (e.g. glutathione-S-transferases GST)…in rodents….Increased GST activity by coffee has been further demonstrated in human following consumption of 800 ml of coffee for 5 days. This kind of antioxidant activity is known to protect against ‘oxidative stress’ by reducing damaging free radicals that may be implicated e.g. in cancer, heart disease, degenerative brain disorders and ageing. Bel-Rhild in para. [0036] further states “The products of the invention may be used to enhance antioxidant-capacity in vivo in a human of animal consuming a beverage prepared from the products of the invention, e.g. by inducing detoxifying enzymes such as glutathione-S-transferase (GST) and by increasing the Nrf2-mediated gene expression pathway. Increased Nrf2 activity associated genes have been reported to enhance detoxification and to stimulate the endogenous defense against oxidative stress.”
Bel-Rhild in para. [0062]-[0064] teaches an Antioxidant Response Element (ARE) Luciferase Assay and the results of its tests of the assay. Bel-Rhild in para. [0063] states “Human breast cancer cells (AREc32) stably transfected with several copies of the rat GSTA2-ARE reporter construct was used to demonstrate the activation of Nrf2-ARE pathway by coffee. Green coffee extract not treated to hydrolyse chlorogenic acids, and different green coffee extract treated with L. johnsonii for 24 h produced a dose-dependent increase in Nrf2-luciferase reporter activity.”
This does not sufficiently provide a definition for “increasing antioxidant capacity, reducing oxidative stress and/or enhancing mitochondrial function” because the teachings in Bel-Rhid show that that antioxidant capability of coffee and/or coffee products is through the induction of detoxifying enzymes, which have not been shown to be applicable in the instant disclosure. Essentially, Bel-Rhild has only provided one pathway of “increasing antioxidant capacity” and/or “reducing oxidative stress” which is not clearly connected to the administration of CBDA.
The rejections are maintained.
Conclusion
No claims 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 LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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/L.G./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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