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 .
Status of the Claims
Claims 22-43 are pending in the instant application.
Election/Restrictions
Applicant's election with traverse of Group I, claims 22-30 and 39-43, drawn to a method of treating metabolic stress comprising the consumption of a composition containing choline and succinate, in the reply filed on May 13, 2026 is acknowledged. The traversal is on the ground(s) that the identified shared technical feature is construed too narrowly. The shared technical feature in the art is “a composition containing choline and succinate in a ratio of 2:1”, whereas the actual shared feature requires “a daily dosage effective to reduce catabolism and/or promoting anabolism in the subject”. This is not found persuasive because this effect would. See MPEP 2112.I and rejections under 35 U.S.C. 103 below in this office action.
The requirement is still deemed proper and is therefore made FINAL.
Applicant's election with traverse of a composition species comprising dicholine succinate and no further components in the reply filed on May 13, 2026 is acknowledged. The traversal is on the ground(s) that the species election. This is not found persuasive because the election requirement indicated to “elect a single disclosed composition by electing every single component present”. The component required in claim 22 is “choline and succinate in a molar ratio of choline to succinate of 2:1” and thus a component in this category must necessarily contain both choline and succinate. Choline and succinate are inseparable, and would not each be a species of this component.
The requirement is still deemed proper and is therefore made FINAL.
Claims 31-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 May 13, 2026.
Claims 25-28 and 41-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 13, 2026.
Claims 22-24, 29-30, and 39-40 are under examination as they relate to the elected invention of group I, drawn to a method of reducing metabolic stress in a subject by providing to the subject a composition containing choline and succinate in a molar ratio of 2:1 and elected composition species comprising dicholine succinate and no further components.
Priority
This application claims foreign priority to GB2112170.2, filed Aug 25, 2021 and is a 371 of PCT/GB2022/052175, filed Aug 24, 2022.
Claim Objections
Claims 1 objected to because the phrase “a daily dosage effective to reduce catabolism and/or promoting anabolism in the subject” should read “a daily dosage effective to reduce catabolism and/or promote anabolism in the subject” in each of these claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 22-24 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.
The term “initial dosage period” in claim 22 is a relative term which renders the claim indefinite. The term “initial dosage period” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not . Claims 23-24 and 29-30, which depend on claim 22, inherit this issue and are similarly rejected. Although claim 30 further specifies the initial dosage period is at least 7 days, it still does not indicate what said dosage period is “initial” to. It is not clear if the claims require that the subject is treatment naïve (i.e. not previously exposed to dicholine succinate) or if the claim is referring to treatment cycles. Moreover, it is not clear what follows the at least 7 days. The same term “initial dosage period” renders claims 39 and 40 indefinite for the same reasons.
Claim 24 is further rejected because Claim 23 recites the limitation “the daily dosage of DiSu”. There is insufficient antecedent basis for this limitation in the claim, as claim 22 recites choline and succinate in a molar ratio of 2:1 and does not refer to DiSu. For examination purposes, claim 24 will be construed as being dependent on claim 23, which does recite DiSu.
Claim Rejections - 35 USC § 102
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.
Claims 22-24, 29-30, and 39-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andreeva et al. (US. 2020/0171019 A1, cited in the restriction requirement mailed April 02, 2026 and in the IDS filed Feb 21, 2024).
Andreeva recites a method of administering to a human a composition consisting of a solution of choline cation and succinate anion in a molar ratio of 2:1 to reduce the likelihood of the human experiencing a condition or symptom associated with imbalanced, damaged, or reduced brain energy metabolism (claim 31). Andreeva further recites wherein the composition consists essentially of dicholine succinate (claim 32), wherein the composition is administered for a period of 7 days (claim 42), and wherein the composition is formulated as a beverage or a food (claim 43). In one embodiment, Andreeva teaches administering 10 mg/kg dicholine succinate for 7 days to rats protects the brain from ATP decline associated with global ischemia (paras. [0089]-[0090]). In another embodiment, Andreeva teaches a beverage comprising 250 mg dicholine succinate is useful for improvement of brain energy metabolism in a subject (p. 6, para. [0076]).
Regarding claims 22-23, the method of administering a composition consisting of a solution of choline cation and succinate anion in a molar ratio of 2:1 to reduce the likelihood of the human experiencing a condition or symptom associated with imbalanced, damaged, or reduced brain energy metabolism reads on a method of reducing metabolic stress in a subject experiencing metabolic stress comprising providing to the subject a composition comprising dicholine succinate.
The prior art is silent regarding dicholine succinate "reducing catabolism and/or promoting anabolism". However: "reducing catabolism and/or promoting anabolism" will inevitably flow from the teachings of the prior art (see above rejection), since the same compound (dicholine succinate) is being administered to the same subjects (a subject suffering from metabolic stress). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding "reducing catabolism and/or promoting anabolism", by practicing the method taught by the prior art: "the administration of a dicholine succinate to a patient suffering from metabolic stress", one will also be "promoting sensory hair cell regeneration,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("promoting sensory hair cell regeneration") of the method taught by the prior art ("the administration of Compound 346, a compound of structure (I) to a patient suffering from hearing loss").
MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Andreeva does not explicitly teach treating “metabolic stress”. However, “reduc[ing] the likelihood of the human experiencing a condition or symptom associated with imbalanced, damaged, or reduced brain energy metabolism”, treating ATP decline in rats, and “improving brain energy metabolism in a subject” all read on reducing catabolic state, where catabolic state is “characterized by disbalanced energy metabolism” as mentioned in the instant specification (p. 7, line 30).
Regarding claim 29, the administration to rats reads on wherein the subject is a domesticated mammal rather than a human subject.
Regarding claim 39, administering the composition as a beverage or a food reads on a method for dietary management of metabolic stress.
Regarding claims 24 and 40, the administration of a beverage containing 250 mg dicholine succinate reads on wherein the daily dosage is in a range from about 100 mg to about 2000 mg per serving.
Therefore, the reference anticipates the instantly claimed invention.
Conclusion
Claims 22-24, 29-30, and 39-40 are rejected.
No claims are allowed.
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/O.D.H./Examiner, Art Unit 1628
/Rayna Rodriguez/Primary Examiner, Art Unit 1628
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