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
This office action is in response to applicant’s reply filed on July 20, 2026.
Restrictions/Elections.
Applicant's election with traverse of Group II (Claims 12-20) in the reply filed on July 20, 2026, is acknowledged.
The traversal is on the ground(s) that searching for both groups will not impose a serious burden. This is not found persuasive because “treating for symptoms of abnormal skeletal muscle conditions” will not necessarily overlap with “increasing muscle mass”. Even though both inventions have in common the word “muscle”, they do not overlap.
The requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Claims 1-20 are currently pending and are the subject of this office action.
Claim 1-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on July 20, 2026.
Claims 12-20 are presently under examination.
Priority
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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) 12-13, 15-18 and 20 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Andreeva et. al. (WO 2019/002858, January 3, 2019, cited by Applicant).
CLAIM INTERPRETATION:
Since the specification does not offer a definition of “subjects in need of increasing skeletal muscle mass”, in its broadest interpretation, any human being is “in need of increasing skeletal muscle mass”, regardless of the skeletal mass volume of an individual. For example: even professional athletes with a large skeletal mass volume will benefit from a further “increase of skeletal muscle mass”.
For claims 12-13, Andreeva teaches a method of administering a composition comprising an effective amount of choline and succinate in a molar ratio of choline to succinate 2:1 to individuals suffering from a symptom or condition associated with an imbalanced, damaged or reduced brain energy metabolism (see claims 1-16) or individuals with an increase demand of physical endurance (see page 9, first line). These individuals are considered also “subjects in need of increasing skeletal muscle mass” (see above claim interpretation).
The prior art is silent regarding “the effective amount to increase skeletal muscle mass”. However, Andreeva teaches amounts of 2:1 choline: succinate (DISU) of 250 mg per serving (see beverages 1 and 2 on page 17), 500 mg per serving (see beverage 3 on pages 17-18), and 560 mg per serving (see beverage 4 on page 18), all of which anticipate the instantly claimed range (from about 100 mg to about 1000 mg per serving in claim 2), in one or more servings. One serving of each of the above beverages will also satisfy the condition “up to a total of about 5000 mg per day”.
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the dosage used in the method of the prior art does not possess the same material, structural and functional characteristics of the dosage claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the dosage used in the claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
The prior art is silent regarding “increasing skeletal muscle mass”.
However: “increasing skeletal muscle mass” will inevitably flow from the teachings of Andreeva, since the same composition (2:1 choline: succinate) is being administered to the same subjects (any human being). In other words, products of identical composition cannot exert mutually exclusive properties when administered under the same circumstances.
In other words, even though the prior art is silent regarding “increasing skeletal muscle mass”, by practicing the method of Andreeva: “a method of administering a composition comprising an effective amount of choline and succinate in a molar ratio of choline to succinate 2:1 to individuals suffering from a symptom or condition associated with an imbalanced, damaged or reduced brain energy metabolism or an increase demand of physical endurance", one will also be “increasing skeletal muscle mass”, even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("increasing skeletal muscle mass”) of the method disclosed by Andreeva (“a method of administering a composition comprising an effective amount of choline and succinate in a molar ratio of choline to succinate 2:1 to individuals suffering from a symptom or condition associated with an imbalanced, damaged or reduced brain energy metabolism or an increase demand of physical endurance ").
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).”
For claim 15, Andreeva teaches that the composition further comprises a nicotinamide derivative like: nicotinamide riboside (see claim 5).
For claim 16, Andreeva teaches a molar ratio choline: succinate: nicotinamide of 2: 1: 0.01 to 2: 1: 10 (see claim 2).
For claim 17, Andreeva teaches that the composition further comprises creatine (see claim 9).
For claim 18, Andreeva teaches that the composition can be in the form of a beverage (see beverages 1 through 7 on pages 17-19, see claim 15).
The statement “sport beverage for consumption by a healthy human subject, a physically active human subject, and/or a person engaged in sports” is considered an intended use of a composition anticipated by the prior art: the 2: 1 choline: succinate and does not add any new limitation to the claim. Catalina Mktg. Int’l, Inc. V. Coolsavings.com, Inc., 289 F.3d 801, 808, 62 USPQ2d 1781, 1785 (fed. Cir. 2002). “The recitation of a new intended use for an old product does not make a claim to that old product patentable.” In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997).
For claim 20, Andreeva teaches that the compositions are formulated to be administered to an aging human subject (see page 9, lines 7-29).
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) 14 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andreeva et. al. (WO 2019/002858, January 3, 2019, cited by Applicant).
Andreeva teaches all the limitations of claim 14 (see above 102(a)(1) rejection), except for “providing an initial treatment course that includes at least five to seven days supply of the composition in the selected dosage form”. However, training patients for future treatments is routine practice in the pharmaceutical/medicinal art, thus resulting in the practice of claim 14 with a reasonable expectation of success.
For claim 19, Andreeva teaches that the composition can be in the form of a beverage (see beverages 1 through 7 on pages 17-19).
The statements “nutritional beverage” or “sport beverage” are considered intended uses of a composition anticipated by the prior art: the 2: 1 choline: succinate and does not add any new limitation to the claim. Catalina Mktg. Int’l, Inc. V. Coolsavings.com, Inc., 289 F.3d 801, 808, 62 USPQ2d 1781, 1785 (fed. Cir. 2002). “The recitation of a new intended use for an old product does not make a claim to that old product patentable.” In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997).
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
August 11, 2026.
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