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 .
This office action is in response to the application filed on October 24, 2022. The earliest effective filing date of the application is October 25, 2021.
Status of Application
The amendment filed November 21, 2025 with the Remarks has been entered. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1 – 4 and 6 – 20
Withdrawn claims: 11 and 17
Newly cancelled claims: 5
Claims currently under consideration: 1 – 4, 6 – 10, 12 – 16, and 18 – 20
The status of the objections and rejections regarding the disclosure upon entry of the present amendment stands as follows:
Objections: The previous objections to claims 12, 18, and 20 have been withdrawn in light of applicant’s amendments.
Withdrawn Rejections: All previous rejections of claim 5 are withdrawn due to the cancellation of claim 5. The previous rejection under 35 U.S.C. § 112(b) of claims 1 – 4, 6 – 10, and 12 – 16 are withdrawn in light of applicant’s amendments. The previous rejection under 35 U.S.C. § 103 over Victoria Health of claims 1 – 4, 6 – 10, 12 – 16, and 18 – 20 are withdrawn in light of applicant’s arguments. Therefore, this action is NONFINAL.
35 U.S.C. § 112 Rejections: The previous rejection under 35 U.S.C. § 112(b) of claims 18 – 20 is maintained. A new rejection 35 U.S.C. § 112(b) of claim 9 is presented below.
35 U.S.C. § 103 Rejections: A new rejection 35 U.S.C. § 103 of claims 1 – 4, 6 – 10, 12 – 16 and 18 – 20 over McCleary is presented below.
Claim Interpretation
Claims 1, 12, and 18 recite “a single dose” in the preamble, which is interpreted to mean that when considering the serving size of the composition, the entire composition is considered one “serving”.
Claims 1, 12, and 18 recite “electrolyte salt” which is interpreted broadly to mean a salt of any ion capable of conducting electricity.
Claims 1 – 3, 12, and 18 recite “about” which, as stated in the instant application, when referring to a measurable value such as an amount of a compound, dose, time, temperature, and the like, is meant to encompass variations of up to 20% of the specified amount ([0023]).
Claims 1, 3, 6, 9, 10, 12 – 14, and 18 recite “pharmaceutically acceptable” which is interpreted broadly to mean edible.
Claim 3 is interpreted broadly to either: i. further limit the amount/serving and the type of trimethylglycine as introduced in claim 1, or ii. Introduce additional components.
Claim 4 recites “non-alcoholic beverage” which is interpreted broadly to be an edible liquid without alcohol.
Claim 6 is interpreted broadly to either: i. further limit the type of beta-hydroxybutyric acid as introduced in claim 1, or ii. Introduce additional components.
Claim Rejections - 35 USC § 112
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 9 and 18 – 20 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 9 recites “pharmaceutically acceptable salt”, yet describes an electrolyte salt in the body of the claim. It is unclear if “pharmaceutically acceptable salt” is meant to expand upon the established “pharmaceutically acceptable salts” in claim 1 somehow, or if claim 9 is still meant to describe electrolytes, as previously presented. For the purpose of examination, claim 9 is still meant to limit the species of the electrolyte salt in claim 1 because the body of claim 9 describes electrolytes.
Claims 18 – 20 recite or depend on a claim that recites the term “pharmaceutically acceptable precursor” which renders the claim indefinite. It is unclear what metes and bounds are encompassed by the recitation “precursor”. For example, molecular carbon may be a precursor of trimethylglycine. For the purpose of examination, a “precursor” of trimethylglycine is interpreted to be any molecule present in trimethylglycine or able to aid in the production of trimethylglycine via biological, chemical, or thermodynamic processes.
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.
Claims 1, 3, 4, 6, 7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over McCleary et al. (US 20050002992 A1) in view of Millet (US 20200121623 A1) and Van Buren et al. (WO 9501097 A1), as evidenced by NIH (What is a Standard Drink? National Institute of Alcohol Abuse and Alcoholism. (2025). Retrieved from: https://www.niaaa.nih.gov/alcohols-effects-health/what-standard-drink).
Regarding claim 1, McCleary teaches an orally administered brain or nerve enhancement supplement ([0170]). McCleary teaches the brain or nerve enhancement supplement comprises 100 – 3,000 mg of betaine (i.e., trimethylglycine – p. 13 – 14, Table X). McCleary teaches the brain or nerve enhancement supplement comprises chromium (p. 13 – 14, Table X). McCleary teaches chromium can be added in the form of a non-toxic salt, such as, e.g., chromium diglycinate, chromium arginate, chromium polynicotinate, and the like ([0088]). McCleary teaches other ingredients can include flavorings and sweeteners such as sugar and maltodextrin (i.e., carbohydrates – [0245]).
The range of betaine (i.e., trimethylglycine) content in the brain or nerve enhancement supplement, 100 – 3,000 mg, as disclosed by McCleary, overlaps with the claimed range of 1,000 – 7,000 mg/serving. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
McCleary does not teach the supplement comprises beta-hydroxybutyric acid.
Millet teaches a composition comprising beta-hydroxybutyric acid (BHB – Abstract). Millet teaches the metabolism of BHB provides, among other benefits, anticonvulsant effects, enhanced brain metabolism, neuroprotection, and improved cognitive performance ([0006]).
McCleary and Millet are combinable because they are concerned with the same field of endeavor, namely, brain and nerve enhancement supplements. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included BHB salt, as taught by Millet in the composition of McCleary because BHB provides, among other benefits, anticonvulsant effects, enhanced brain metabolism, neuroprotection, and improved cognitive performance, which would further the brain and nerve enhancement goal of the supplement of McCleary.
McCleary does not teach the supplement comprises about 1 mg/serving to about 4,000 mg/serving of beta-hydroxybutyric acid.
Millet teaches administering about 1,000 mg to about 50,000 mg of BHB salt per dose ([0072]).
The range of BHB salt per dose, about 1,000 mg to about 50,000 mg, as disclosed by Millet, overlaps with the claimed range of about 1 mg/serving to about 4,000 mg/serving. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
McCleary does not teach the supplement comprises a purine nucleotide.
Van Buren teaches a liquid dietary supplement comprising a therapeutically effective concentration of a nucleotide comprising adenine (i.e., a purine nucleotide) and a pharmacologically acceptable carrier, wherein said nucleotide is capable of promoting wound healing in an animal (Claims 1, 2, and 4). Van Buren teaches purine nucleotides are involved in almost all cellular processes and play a major role in structural, metabolic, energetic, and regulatory functions (p. 4, lines 10 – 13). Van Buren teaches the major purine bases are adenine, guanine, hypoxanthine, and xanthine (p. 5, lines 7 – 8). Van Buren teaches adenine (i.e., a purine nucleotide) supplementation significantly improves wound healing in vivo relative to a non-supplemented diet (p. 31, lines 9 – 18; Figure 1).
McCleary and Van Buren are combinable because they are concerned with the same field of endeavor, namely, dietary supplementation. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have added a nucleotide comprising adenine (i.e., a purine nucleotide), as taught by Van Buren, to the supplement of McCleary because nucleotides comprising adenine (i.e., a purine nucleotides) provide benefits such as wound healing in addition to the brain and nerve enhancement effects in the brain and nerve enhancement supplement of McCleary.
With respect to the aqueous carrier as recited in claim 1, McCleary teaches the brain or nerve enhancement supplement is added to an alcoholic beverage ([0046]; [0050] – [0053]; [0172]; Claims 12 and 13). McCleary teaches the preferred alcoholic beverages are beer, wine, liquors, liqueurs, flavored alcohols, brandies, cocktails, aperitifs, and cordials ([0053]).
While McCleary does not teach the volume of the alcoholic beverage comprising the brain and nerve enhancement supplement is between 2 oz and 32 oz, alcoholic beverages have standard volumes, as evidenced by NIH (Image, p. 2 – 5). Various standard volumes of alcoholic beverages are below:
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While the volume of each alcoholic beverage recited by McCleary is not explicitly stated, by selecting, for example, beer as the alcoholic beverage (i.e., aqueous carrier) comprising the brain or nerve enhancement supplement, a serving size of 12 oz is necessarily selected. Therefore, McCleary teaches a range of volumes which may be selected depending on which alcoholic beverage is chosen as the carrier for the brain or nerve enhancement supplement, including 1.5 oz/serving, 2 – 4 oz/serving, 5 oz/serving, 8 – 10 oz/serving, and 12 oz/serving.
The range of alcoholic beverage volumes, 1.5 oz/serving, 2 – 4 oz/serving, 5 oz/serving, 8 – 10 oz/serving, and 12 oz/serving, as disclosed by McCleary, overlaps with the claimed range of about 2 oz/serving to about 32 oz/serving. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 3, McCleary teaches the betaine is anhydrous trimethylglycine ([0254]).
The range of betaine (i.e., anhydrous trimethylglycine) content in the brain or nerve enhancement supplement, 100 – 3,000 mg, as disclosed by McCleary, overlaps with the claimed range of 1,000 – 2,000 mg/serving. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
The range of BHB salt per dose, about 1,000 mg to about 50,000 mg, as disclosed by Millet, overlaps with the claimed range of about 500 mg/serving to about 2,000 mg/serving. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 4, the dosage form as taught by McCleary above is an alcoholic beverage.
Regarding claims 6 and 7, Millet teaches the BHB composition may also comprise BHB salts selected from sodium and potassium,(i.e., alkali metal salts); and calcium and magnesium (i.e., alkaline earth metal salts – Abstract; [0014]).
Regarding claim 10, McCleary teaches the brain or nerve enhancement supplement comprises chromium (p. 13 – 14, Table X). McCleary teaches chromium can be added in the form of a non-toxic salt, such as, e.g., chromium diglycinate, chromium arginate, chromium polynicotinate, and the like ([0088]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over McCleary et al. (US 20050002992 A1) in view of Millet (US 20200121623 A1) and Van Buren et al. (WO 9501097 A1), as evidenced by NIH (What is a Standard Drink? National Institute of Alcohol Abuse and Alcoholism. (2025). Retrieved from: https://www.niaaa.nih.gov/alcohols-effects-health/what-standard-drink), as applied to claim 1 above, and as further evidenced by Gallup (American’s Average Weight Holds Steady in 2020. Gallup. (2021). Retrieved from: https://news.gallup.com/poll/328241/americans-average-weight-holds-steady-2020.aspx).
McCleary does not teach the supplement comprises about 0.1 mg to about 1,000 mg of a purine nucleotide.
Van Buren teaches the content of adenine (i.e., a purine nucleotide) in the supplement is preferably 0.34 mg/kg body weight/day to 170 mg/kg body weight/day (p. 16, lines 6 – 11). While the human population exhibits a broad range of adult body weights, as evidenced by Gallup, the average adult body weight in the United States is about 181 lbs (i.e., 82 kg – p. 2, paragraph 2). Therefore, the teachings of Van Buren suggest including adenine (i.e., a purine nucleotide) in an amount of about 28 mg/day to about 13,940 mg/day.
The range of adenine (i.e., a purine nucleotide) content in the supplement, about 28 mg/day to about 13,940 mg/day, as disclosed by Van Buren, overlaps with the claimed range of 0.1 mg to about 1,000 mg. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over McCleary et al. (US 20050002992 A1) in view of Millet (US 20200121623 A1) and Van Buren et al. (WO 9501097 A1), as evidenced by NIH (What is a Standard Drink? National Institute of Alcohol Abuse and Alcoholism. (2025). Retrieved from: https://www.niaaa.nih.gov/alcohols-effects-health/what-standard-drink), as applied to claim 1 above, and further in view of Cuenoud et al. (Metabolism of Exogenous D-Beta-Hydroxybutyrate, an Energy Substrate Avidly Consumed by the Heart and Kidney. Frontiers in Nutrition. Vol. 7. (18 February 2020)).
The modified composition of McCleary does not teach the beta-hydroxybutyric acid is from 90% to 99.99% D-beta-hydroxybutyric acid.
Cuenoud teaches D-BHB (i.e., D-beta-hydroxybutyrate) is rapidly absorbed and metabolized (p. 5, paragraph 3; Figure 2). Cuenoud teaches increases blood ketones above 1 mM, a level ∼1.7 fold greater than the same dose of D+L-BHB (i.e., a racemic mixture of beta-hydroxybutyrate), and this despite the lower caloric load of D-BHB (p. 5, paragraph 3). Cuenoud teaches while D-BHB is readily utilized as an energy source, the L-isoform is eliminated slowly in the urine and does not contribute significantly to the biological activity of ketone precursors as an energy source (p. 6, paragraph 2).
The modified composition of McCleary and Cuenoud are combinable because they are concerned with the same field of endeavor, namely, supplementation of beta-hydroxybutyrate. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have ensured the beta-hydroxybutyrate in the brain or nerve enhancement supplement of McCleary is from 90% to 99.99% D-beta-hydoxybutyrate (i.e., D-beta-hydroxybutyric acid), as taught by Cuenoud because D-beta-hydoxybutyrate is more readily absorbed than it’s L-isoform, and it increases blood ketones at a level ∼1.7 fold greater than the same dose of D+L-BHB (i.e., a racemic mixture of beta-hydroxybutyrate) despite the lower caloric load of D-BHB (i.e., D-beta-hydroxybutyrate).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over McCleary et al. (US 20050002992 A1) in view of Millet (US 20200121623 A1) and Van Buren et al. (WO 9501097 A1), as evidenced by NIH (What is a Standard Drink? National Institute of Alcohol Abuse and Alcoholism. (2025). Retrieved from: https://www.niaaa.nih.gov/alcohols-effects-health/what-standard-drink), as applied to claim 1, and further in view of Cleveland Clinic (Electrolytes. Cleveland Clinic. (September 24, 2021). Retrieved from: https://my.clevelandclinic.org/health/diagnostics/21790-electrolytes).
McCleary does not teach the pharmaceutically acceptable salt is selected from the group consisting of: a bicarbonate, citrate, phosphate, or chloride salt of an alkali metal; a bicarbonate, citrate, phosphate, or chloride salt of an alkaline earth metal; and a mixture thereof.
Cleveland Clinic teaches electrolytes are substances that have a natural positive or negative electrical charge when dissolved in water (p. 1, paragraph 1). Cleveland Clinic teaches electrolytes help your body regulate chemical reactions, maintain the balance between fluids inside and outside your cells, and more (p. 1, paragraph 1). Cleveland Clinic teaches there are several key elements that your body needs to maintain normal electrolyte levels, most notably sodium, magnesium, potassium, calcium, chloride, phosphate, and bicarbonate (p. 3 – 6).
Cleveland Clinic teaches calcium is a key element in your body, but it does more than just build strong bones and teeth; it’s also used to control your muscles, transmit signals in your nerves, manage your heart rhythm and more (p. 4, Calcium (+)). Cleveland Clinic teaches too much calcium can cause headache, fatigue, apathy and confusion, constipation, abdominal pain and vomiting, frequent need to pee, kidney stones and kidney failure, heart arrhythmias, some of which can be severe, and pain in the bones and joints (p. 4, Calcium (+)). Cleveland Clinic teaches not enough calcium can cause confusion and behavior changes and unusually strong reflexes and loss of muscle control, muscle twitching, spasms in the throat muscles making it hard to speak or breathe (p. 4, Calcium (+)).
Cleveland Clinic teaches phosphate is a phosphorous-based molecule that’s a key part of transporting chemical compounds and molecules outside your cells and helps your cells metabolize nutrients, and it’s also a key part of molecules called nucleotides, which are the building blocks that make up your DNA (p. 5, Phosphate (-)). Cleveland Clinic teaches too much phosphate typically causes you to experience hypocalcemia because your body tries to use calcium as a substitute for phosphorus (p. 5, Phosphate (-)). Cleveland Clinic teaches not enough phosphate can cause rhabdomyolysis (breakdown of muscle tissue, which can cause severe kidney damage), seizures, reduced heart function and trouble breathing (caused by muscle weakness – p. 5, Phosphate (-)).
McCleary and Cleveland Clinic are combinable because they are concerned with the same field of endeavor, namely, dietary supplementation. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included a pharmaceutically acceptable salt of calcium and phosphate, as taught by Cleveland Clinic in the brain or nerve enhancement supplement of McCleary to provide the desired health benefits of calcium and phosphate in addition to the brain or nerve enhancement effects of the supplement of McCleary, while mediating the potential calcium-siphoning side effects of phosphate.
Claims 12, 13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over McCleary et al. (US 20050002992 A1) in view of Millet (US 20200121623 A1), Van Buren et al. (WO 9501097 A1), Shyam et al. (Isomaltulose: Recent evidence for health benefits. Journal of Functional Foods. Vol 48. Pp. 173 – 178. (2018)), LabPro (Top 5 Uses of Phosphoric Acid. Lab Pro. (June 15, 2021). Retrieved from: https://labproinc.com/blogs/chemicals-and-solvents/top-5-uses-of-phosphoric-acid), and IFIC (Everything you Need to Know about Stevia Sweeteners. International Food Information Council. (April 20, 2021). Retrieved from: https://ific.org/resources/articles/everything-you-need-to-know-about-stevia-sweeteners/), as evidenced by NIH (What is a Standard Drink? National Institute of Alcohol Abuse and Alcoholism. (2025). Retrieved from: https://www.niaaa.nih.gov/alcohols-effects-health/what-standard-drink) and Gallup (American’s Average Weight Holds Steady in 2020. Gallup. (2021). Retrieved from: https://news.gallup.com/poll/328241/americans-average-weight-holds-steady-2020.aspx).
Regarding claim 12, McCleary teaches an orally administered brain or nerve enhancement supplement ([0170]). McCleary teaches the brain or nerve enhancement supplement comprises 100 – 3,000 mg of betaine (i.e., trimethylglycine – p. 13 – 14, Table X). McCleary teaches the brain or nerve enhancement supplement comprises chromium (p. 13 – 14, Table X). McCleary teaches chromium can be added in the form of a non-toxic salt, such as, e.g., chromium diglycinate, chromium arginate, chromium polynicotinate, and the like ([0088]). McCleary teaches the brain or nerve enhancement supplement can comprise inactive excipients, carriers, diluents, lubricants, and adjuvants such as glycerin (i.e., glycerol – [0245]).
The range of betaine (i.e., trimethylglycine) content in the brain or nerve enhancement supplement, 100 – 3,000 mg, as disclosed by McCleary, overlaps with the claimed range of 1,000 – 10,000 mg/serving. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
McCleary does not teach the supplement comprises beta-hydroxybutyric acid.
Millet teaches a composition comprising beta-hydroxybutyric acid (BHB – Abstract). Millet teaches the metabolism of BHB provides, among other benefits, anticonvulsant effects, enhanced brain metabolism, neuroprotection, and improved cognitive performance ([0006]).
McCleary and Millet are combinable because they are concerned with the same field of endeavor, namely, brain and nerve enhancement supplements. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included BHB salt, as taught by Millet in the composition of McCleary because BHB provides, among other benefits, anticonvulsant effects, enhanced brain metabolism, neuroprotection, and improved cognitive performance, which would further the brain and nerve enhancement goal of the supplement of McCleary.
McCleary does not teach the supplement comprises about 1 mg/serving to about 10,000 mg/serving of beta-hydroxybutyric acid.
Millet teaches administering about 1,000 mg to about 50,000 mg of BHB salt per dose ([0072]).
The range of BHB salt per dose, about 1,000 mg to about 50,000 mg, as disclosed by Millet, overlaps with the claimed range of about 1 mg/serving to about 10,000 mg/serving. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
With respect to the aqueous carrier as recited in claim 12, McCleary teaches the brain or nerve enhancement supplement is added to an alcoholic beverage ([0046]; [0050] – [0053]; [0172]; Claims 12 and 13). McCleary teaches the preferred alcoholic beverages are beer, wine, liquors, liqueurs, flavored alcohols, brandies, cocktails, aperitifs, and cordials ([0053]).
While McCleary does not teach the volume of the alcoholic beverage comprising the brain and nerve enhancement supplement is between 2 oz and 32 oz, alcoholic beverages have standard volumes, as evidenced by NIH (Image, p. 2 – 5). Various standard volumes of alcoholic beverages are shown in paragraph 34 above.
While the volume of each alcoholic beverage recited by McCleary is not explicitly stated, by selecting, for example, beer as the alcoholic beverage (i.e., aqueous carrier) comprising the brain or nerve enhancement supplement, a serving size of 12 oz is necessarily selected. Therefore, McCleary teaches a range of volumes which may be selected depending on which alcoholic beverage is chosen as the carrier for the brain or nerve enhancement supplement, including 1.5 oz/serving, 2 – 4 oz/serving, 5 oz/serving, 8 – 10 oz/serving, and 12 oz/serving.
The range of alcoholic beverage volumes, 1.5 oz/serving, 2 – 4 oz/serving, 5 oz/serving, 8 – 10 oz/serving, and 12 oz/serving, as disclosed by McCleary, overlaps with the claimed range of about 2 oz/serving to about 32 oz/serving. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
McCleary does not teach the supplement comprises a purine nucleotide.
Van Buren teaches a liquid dietary supplement comprising a therapeutically effective concentration of a nucleotide comprising adenine (i.e., a purine nucleotide) and a pharmacologically acceptable carrier, wherein said nucleotide is capable of promoting wound healing in an animal (Claims 1, 2, and 4). Van Buren teaches purine nucleotides are involved in almost all cellular processes and play a major role in structural, metabolic, energetic, and regulatory functions (p. 4, lines 10 – 13). Van Buren teaches the major purine bases are adenine, guanine, hypoxanthine, and xanthine (p. 5, lines 7 – 8). Van Buren teaches adenine (i.e., a purine nucleotide) supplementation significantly improves wound healing in vivo relative to a non-supplemented diet (p. 31, lines 9 – 18; Figure 1).
McCleary and Van Buren are combinable because they are concerned with the same field of endeavor, namely, dietary supplementation. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have added a nucleotide comprising adenine (i.e., a purine nucleotide), as taught by Van Buren, to the supplement of McCleary because nucleotides comprising adenine (i.e., a purine nucleotides) provide benefits such as wound healing in addition to the brain and nerve enhancement effects in the brain and nerve enhancement supplement of McCleary.
McCleary does not teach the supplement comprises about 0.1 mg to about 1,000 mg of a purine nucleotide.
Van Buren teaches the content of adenine (i.e., a purine nucleotide) in the supplement is preferably 0.34 mg/kg body weight/day to 170 mg/kg body weight/day (p. 16, lines 6 – 11). While the human population exhibits a broad range of adult body weights, as evidenced by Gallup, the average adult body weight in the United States is about 181 lbs (i.e., 82 kg – p. 2, paragraph 2). Therefore, the teachings of Van Buren suggest including adenine (i.e., a purine nucleotide) in an amount of about 28 mg/day to about 13,940 mg/day.
The range of adenine (i.e., a purine nucleotide) content in the supplement, about 28 mg/day to about 13,940 mg/day, as disclosed by Van Buren, overlaps with the claimed range of 0.1 mg to about 1,000 mg. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
While McCleary teaches sweeteners such as sugar and maltodextrin may be included in the brain or nerve enhancement supplement [0245]); McCleary does not teach the supplement comprises isomaltulos.
Shyam teaches isomaltulose (IM) is regarded as ‘a slow, yet fully digestible carbohydrate with low glycemic index (p. 173, paragraph 1). Shyam teaches IM is used as a replacement to other sugars and maltodextrins in foods and beverages (p. 173, paragraph 4). Shyam teaches IM has a pure and natural sucrose-like sweetness, but with a 50% sweetening power of sucrose (p. 174, paragraph 2). Shyam teaches IM has been described to be “tooth-friendly” as it is reportedly the only sugary carbohydrate that resists oral fermentation (p. 174, paragraph 3).
McCleary and Shyam are combinable because they are concerned with the same field of endeavor, namely, beverages comprising sweeteners. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to included isomaltulose (i.e., isomaltulos) as a sweetener, as taught by Shyam in the brain or nerve enhancement supplement of McCleary because isomaltulose (i.e., isomaltulos) is a known replacement of sugar and maltodextrin while also being the only sugary carbohydrate that resists oral fermentation.
While McCleary teaches small amounts of additional ingredients may be added as known in the food art such as any preservative that is approved for use in foods ([0245]); McCleary does not teach the supplement comprises phosphoric acid.
LabPro teaches the world recognizes phosphoric acid as a food additive (p.2, paragraph 4). LabPro teaches phosphoric acid is present in a host of food products, including cheese, processes meats, cereal bars, jams, cola drinks and lots more (p.3, paragraph 4). LabPro teaches phosphoric acid works like an acidity regulator in the products and as an acidulant in beverages (p.3, paragraph 5). LabPro teaches the main goal of using this substance is to prevent food items and drinks from bacterial formation and fungi (i.e., phosphoric acid is a preservative – p.3, paragraph 5).
McCleary and LabPro are combinable because they are concerned with the same field of endeavor, namely, preservatives. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included phosphoric acid, as taught by LabPro, in the brain or nerve enhancement supplement of McCleary because phosphoric acid is a known acidity regulator and preservative that is suitable for use in beverages, and it would have been obvious to select phosphoric acid as the preservative in the brain or nerve enhancement supplement of McCleary on the basis of its suitability for a similar intended use. See MPEP § 2144.07.
While McCleary teaches sweeteners may be included in the brain or nerve enhancement supplement [0245]); McCleary does not teach the supplement comprises steviol glycosides.
IFIC teaches stevia sweeteners are no-calorie sweeteners that can be used to lower one’s intake of added sugars while still providing satisfaction from enjoying the taste of something sweet (p. 1, paragraph 1). IFIC teaches Like other no-calorie sweeteners, stevia sweeteners are intensely sweet. Stevia sweeteners range from being 200-350 times sweeter than sugar, and as such only small amounts of stevia sweeteners are needed to match the sweetness provided by sugar (p. 1, paragraph 2). IFIC teaches stevia sweeteners can be used by food and beverage manufacturers as an ingredient in beverages (such as diet sodas, light or low-sugar juices and flavored waters – p. 1, paragraph 2). IFIC teaches stevia sweeteners are made by extracting steviol glycosides from the leaves of the stevia plant and purifying them to remove some of the bitter attributes found in the crude extract (p. 1, paragraph 4).
McCleary and IFIC are combinable because they are concerned with the same field of endeavor, namely, beverages comprising sweeteners. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included stevia sweetener (i.e., steviol glycosides) as a sweetener, as taught by IFIC in the brain or nerve enhancement supplement of McCleary because stevia sweeteners (i.e., steviol glycosides) are intensely sweet and suitable for use in beverages.
Regarding claim 13, McCleary teaches the betaine is anhydrous trimethylglycine ([0254]).
Regarding claim 16, McCleary teaches the brain or nerve enhancement supplement comprises 2 mg – 50 mg zinc (p. 13 – 14, Table X).
The range of zinc content in the brain or nerve enhancement supplement, 2 mg – 50 mg, as disclosed by McCleary, overlaps with the claimed range of 1 mg/serving to 12 mg/serving. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over McCleary et al. (US 20050002992 A1) in view of Millet (US 20200121623 A1), Van Buren et al. (WO 9501097 A1), Shyam (Isomaltulose: Recent evidence for health benefits. Journal of Functional Foods. Vol 48. Pp. 173 – 178. (2018)), LabPro (Top 5 Uses of Phosphoric Acid. Lab Pro. (June 15, 2021). Retrieved from: https://labproinc.com/blogs/chemicals-and-solvents/top-5-uses-of-phosphoric-acid), and IFIC (Everything you Need to Know about Stevia Sweeteners. International Food Information Council. (April 20, 2021). Retrieved from: https://ific.org/resources/articles/everything-you-need-to-know-about-stevia-sweeteners/), as evidenced by NIH (What is a Standard Drink? National Institute of Alcohol Abuse and Alcoholism. (2025). Retrieved from: https://www.niaaa.nih.gov/alcohols-effects-health/what-standard-drink) and Gallup (American’s Average Weight Holds Steady in 2020. Gallup. (2021). Retrieved from: https://news.gallup.com/poll/328241/americans-average-weight-holds-steady-2020.aspx), as applied to claim 12 above, and further in view of Cuenoud et al. (Metabolism of Exogenous D-Beta-Hydroxybutyrate, an Energy Substrate Avidly Consumed by the Heart and Kidney. Frontiers in Nutrition. Vol. 7. (18 February 2020)).
McCleary does not teach the supplement comprises a pharmaceutically acceptable alkali metal salt or alkaline earth metal salt of beta-hydroxybutyric acid.
Millet teaches the BHB composition may also comprise BHB salts selected from sodium and potassium,(i.e., alkali metal salts); and calcium and magnesium (i.e., alkaline earth metal salts – Abstract; [0014]).
McCleary does not teach the alkali metal salt of beta-hydroxybutyric acid is an alkali metal salt of D-beta-hydroxybutyric acid, a pharmaceutically acceptable alkaline earth metal salt of D-beta-hydroxybutyric acid, or a mixture thereof.
Cuenoud teaches D-BHB (i.e., D-beta-hydroxybutyrate) is rapidly absorbed and metabolized (p. 5, paragraph 3; Figure 2). Cuenoud teaches increases blood ketones above 1 mM, a level ∼1.7 fold greater than the same dose of D+L-BHB (i.e., a racemic mixture of beta-hydroxybutyrate), and this despite the lower caloric load of D-BHB (p. 5, paragraph 3). Cuenoud teaches while D-BHB is readily utilized as an energy source, the L-isoform is eliminated slowly in the urine and does not contribute significantly to the biological activity of ketone precursors as an energy source (p. 6, paragraph 2).
McCleary and Cuenoud are combinable because they are concerned with the same field of endeavor, namely, supplementation of beta-hydroxybutyrate. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have selected D-beta-hydoxybutyrate (i.e., D-beta-hydroxybutyric acid) as the beta-hydroxybutyrate in the sodium, potassium (i.e., alkali metals); calcium, and/or magnesium (i.e., alkaline earth metals) salt in the brain or nerve enhancement supplement of McCleary, as taught by Cuenoud because D-beta-hydoxybutyrate is more readily absorbed than it’s L-isoform, and it increases blood ketones at a level ∼1.7 fold greater than the same dose of D+L-BHB (i.e., a racemic mixture of beta-hydroxybutyrate) despite the lower caloric load of D-BHB (i.e., D-beta-hydroxybutyrate).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over McCleary et al. (US 20050002992 A1) in view of Millet (US 20200121623 A1), Van Buren et al. (WO 9501097 A1), Shyam (Isomaltulose: Recent evidence for health benefits. Journal of Functional Foods. Vol 48. Pp. 173 – 178. (2018)), LabPro (Top 5 Uses of Phosphoric Acid. Lab Pro. (June 15, 2021). Retrieved from: https://labproinc.com/blogs/chemicals-and-solvents/top-5-uses-of-phosphoric-acid), and IFIC (Everything you Need to Know about Stevia Sweeteners. International Food Information Council. (April 20, 2021). Retrieved from: https://ific.org/resources/articles/everything-you-need-to-know-about-stevia-sweeteners/), as evidenced by NIH (What is a Standard Drink? National Institute of Alcohol Abuse and Alcoholism. (2025). Retrieved from: https://www.niaaa.nih.gov/alcohols-effects-health/what-standard-drink) and Gallup (American’s Average Weight Holds Steady in 2020. Gallup. (2021). Retrieved from: https://news.gallup.com/poll/328241/americans-average-weight-holds-steady-2020.aspx), as applied to claim 12 above, and further in view of Cleveland Clinic (Electrolytes. Cleveland Clinic. (September 24, 2021). Retrieved from: https://my.clevelandclinic.org/health/diagnostics/21790-electrolytes).
McCleary does not teach the electrolyte salt comprises from 1 mg/ serving to 2,000 mg/ serving of a bicarbonate, citrate, phosphate, or chloride salt of calcium.
Cleveland Clinic teaches electrolytes are substances that have a natural positive or negative electrical charge when dissolved in water (p. 1, paragraph 1). Cleveland Clinic teaches electrolytes help your body regulate chemical reactions, maintain the balance between fluids inside and outside your cells, and more (p. 1, paragraph 1). Cleveland Clinic teaches there are several key elements that your body needs to maintain normal electrolyte levels, most notably sodium, magnesium, potassium, calcium, chloride, phosphate, and bicarbonate (p. 3 – 6).
Cleveland Clinic teaches calcium is a key element in your body, but it does more than just build strong bones and teeth; it’s also used to control your muscles, transmit signals in your nerves, manage your heart rhythm and more (p. 4, Calcium (+)). Cleveland Clinic teaches too much calcium can cause headache, fatigue, apathy and confusion, constipation, abdominal pain and vomiting, frequent need to pee, kidney stones and kidney failure, heart arrhythmias, some of which can be severe, and pain in the bones and joints (p. 4, Calcium (+)). Cleveland Clinic teaches not enough calcium can cause confusion and behavior changes and unusually strong reflexes and loss of muscle control, muscle twitching, spasms in the throat muscles making it hard to speak or breathe (p. 4, Calcium (+)).
Cleveland Clinic teaches phosphate is a phosphorous-based molecule that’s a key part of transporting chemical compounds and molecules outside your cells and helps your cells metabolize nutrients, and it’s also a key part of molecules called nucleotides, which are the building blocks that make up your DNA (p. 5, Phosphate (-)). Cleveland Clinic teaches too much phosphate typically causes you to experience hypocalcemia because your body tries to use calcium as a substitute for phosphorus (p. 5, Phosphate (-)). Cleveland Clinic teaches not enough phosphate can cause rhabdomyolysis (breakdown of muscle tissue, which can cause severe kidney damage), seizures, reduced heart function and trouble breathing (caused by muscle weakness – p. 5, Phosphate (-)).
McCleary and Cleveland Clinic are combinable because they are concerned with the same field of endeavor, namely, dietary supplementation. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included an electrolyte salt of calcium and phosphate in the amount of 1 mg/serving to 2,000 mg/serving, as taught by Cleveland Clinic in the brain or nerve enhancement supplement of McCleary to provide the desired health benefits of calcium and phosphate in addition to the brain or nerve enhancement effects of the supplement of McCleary, while mediating the potential calcium-siphoning side effects of phosphate.
Regarding the limitation “the formulation comprises from 1 mg/serving to 6,800 mg/serving of the electrolyte salt”, in the case wherein the electrolyte salt comprises only the calcium and phosphate salt in the amount of 1 mg/serving to 2,000 mg/serving, the electrolyte salt would necessarily comprise from 1 mg/serving to 6,800 mg/serving of the electrolyte salt.
Claims 18 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over McCleary et al. (US 20050002992 A1) in view of Millet (US 20200121623 A1), Cleveland Clinic (Electrolytes. Cleveland Clinic. (September 24, 2021). Retrieved from: https://my.clevelandclinic.org/health/diagnostics/21790-electrolytes), Van Buren et al. (WO 9501097 A1), IFIC (Everything you Need to Know about Stevia Sweeteners. International Food Information Council. (April 20, 2021). Retrieved from: https://ific.org/resources/articles/everything-you-need-to-know-about-stevia-sweeteners/), as evidenced by NIH (What is a Standard Drink? National Institute of Alcohol Abuse and Alcoholism. (2025). Retrieved from: https://www.niaaa.nih.gov/alcohols-effects-health/what-standard-drink) and Gallup (American’s Average Weight Holds Steady in 2020. Gallup. (2021). Retrieved from: https://news.gallup.com/poll/328241/americans-average-weight-holds-steady-2020.aspx).
Regarding claim 18, McCleary teaches an orally administered brain or nerve enhancement supplement ([0170]). McCleary teaches the brain or nerve enhancement supplement comprises 100 – 3,000 mg of betaine (i.e., trimethylglycine – p. 13 – 14, Table X). McCleary teaches the brain or nerve enhancement supplement comprises chromium (p. 13 – 14, Table X). McCleary teaches chromium can be added in the form of a non-toxic salt, such as, e.g., chromium diglycinate, chromium arginate, chromium polynicotinate, and the like ([0088]).
The range of betaine (i.e., trimethylglycine) content in the brain or nerve enhancement supplement, 100 – 3,000 mg, as disclosed by McCleary, overlaps with the claimed range of 750 – 1,500 mg/serving. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
McCleary does not teach the supplement comprises beta-hydroxybutyric acid.
Millet teaches a composition comprising beta-hydroxybutyric acid (BHB – Abstract). Millet teaches the metabolism of BHB provides, among other benefits, anticonvulsant effects, enhanced brain metabolism, neuroprotection, and improved cognitive performance ([0006]).
McCleary and Millet are combinable because they are concerned with the same field of endeavor, namely, brain and nerve enhancement supplements. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included BHB salt, as taught by Millet in the composition of McCleary because BHB provides, among other benefits, anticonvulsant effects, enhanced brain metabolism, neuroprotection, and improved cognitive performance, which would further the brain and nerve enhancement goal of the supplement of McCleary.
McCleary does not teach the supplement comprises about 500 mg/serving to about 1,000 mg/serving of beta-hydroxybutyric acid.
Millet teaches administering about 1,000 mg to about 50,000 mg of BHB salt per dose ([0072]).
The range of BHB salt per dose, about 1,000 mg to about 50,000 mg, as disclosed by Millet, overlaps with the claimed range of about 500 mg/serving to about 1,000 mg/serving. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
McCleary does not teach the supplement comprises 500 mg/serving to 1,500 mg/serving of electrolyte salt, wherein the electrolyte salt comprises: a combination of sodium and potassium salts and a combination of magnesium and calcium.
Cleveland Clinic teaches electrolytes are substances that have a natural positive or negative electrical charge when dissolved in water (p. 1, paragraph 1). Cleveland Clinic teaches electrolytes help your body regulate chemical reactions, maintain the balance between fluids inside and outside your cells, and more (p. 1, paragraph 1). Cleveland Clinic teaches there are several key elements that your body needs to maintain normal electrolyte levels, most notably sodium, magnesium, potassium, calcium, chloride, phosphate, and bicarbonate (p. 3 – 6).
Cleveland Clinic teaches sodium plays a critical role in helping your cells maintain the right balance of fluid and helps cells absorb nutrients (p. 3, Sodium (+)). Cleveland Clinic teaches too much sodium can cause confusion or behavior changes, unusually strong reflexes and loss of muscle control, seizures and coma (p. 3, Sodium (+)). Cleveland Clinic teaches not enough sodium can cause confusion, irritability, weakened reflexes, nausea and vomiting, seizures and coma (p. 3, Sodium (+)).
Cleveland Clinic teaches your cells use potassium alongside sodium (p. 4, Potassium (+)). When a sodium ion enters a cell, a potassium ion leaves, and vice versa. Potassium is also especially critical to your heart function (p. 4, Potassium (+)). Cleveland Clinic teaches too much potassium can cause weakness, inability to move muscles, confusion, irregular heart rhythms (arrhythmias – p. 4, Potassium (+)). Cleveland Clinic teaches not enough potassium can cause muscle weakness and cramps, feeling unusually thirsty and needing to pee frequently, dizziness or passing out when standing up too quickly (p. 4, Potassium (+)).
Cleveland Clinic teaches magnesium helps your cells as they turn nutrients into energy (p. 3, Magnesium (+)). Cleveland Clinic teaches the brain and muscles rely heavily on magnesium to do their job. Cleveland Clinic teaches too much magnesium can cause heart rhythm changes and arrhythmias, weakened reflexes, decreased ability to breathe and cardiac arrest (your heart stops – p. 3, Magnesium (+)). Cleveland Clinic teaches not enough magnesium can cause muscle weakness, twitching and loss of control, heart arrhythmias (p. 3, Magnesium (+)).
Cleveland Clinic teaches calcium is a key element in your body, but it does more than just build strong bones and teeth; it’s also used to control your muscles, transmit signals in your nerves, manage your heart rhythm and more (p. 4, Calcium (+)). Cleveland Clinic teaches too much calcium can cause headache, fatigue, apathy and confusion, constipation, abdominal pain and vomiting, frequent need to pee, kidney stones and kidney failure, heart arrhythmias, some of which can be severe, and pain in the bones and joints (p. 4, Calcium (+)). Cleveland Clinic teaches not enough calcium can cause confusion and behavior changes and unusually strong reflexes and loss of muscle control, muscle twitching, spasms in the throat muscles making it hard to speak or breathe (p. 4, Calcium (+)).
McCleary and Cleveland Clinic are combinable because they are concerned with the same field of endeavor, namely, dietary supplementation. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included an electrolyte salt blend of sodium, potassium, magnesium, and calcium in an amount of 500 mg/serving to 1,500 mg/serving, as taught by Cleveland Clinic in the brain or nerve enhancement supplement of McCleary provide the necessary amounts of sodium, potassium, magnesium, and calcium for healthy body function without causing the side effects of sodium, potassium, magnesium, or calcium toxicity, in addition to promoting brain or nerve health as intended by McCleary.
While the modified composition of McCleary and Cleveland Clinic do not teach the sodium and potassium salts are in a ratio of 1:1, based on the weight of the cation, one of ordinary skill in the art would have adjusted the ratio of sodium to potassium during routine optimization to find the supplement formula that results in the best sodium and potassium synergy. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed ratio of sodium and potassium salts, 1:1, based on the weight of the cation, would thus be obvious.
With respect to the aqueous carrier, McCleary teaches the brain or nerve enhancement supplement is added to an alcoholic beverage ([0046]; [0050] – [0053]; [0172]; Claims 12 and 13). McCleary teaches the preferred alcoholic beverages are beer, wine, liquors, liqueurs, flavored alcohols, brandies, cocktails, aperitifs, and cordials ([0053]).
While McCleary does not teach the volume of the alcoholic beverage comprising the brain and nerve enhancement supplement is between 2 oz and 32 oz, alcoholic beverages have standard volumes, as evidenced by NIH (Image, p. 2 – 5). Various standard volumes of alcoholic beverages are shown in paragraph 34 above.
While the volume of each alcoholic beverage recited by McCleary is not explicitly stated, by selecting, for example, beer as the alcoholic beverage (i.e., aqueous carrier) comprising the brain or nerve enhancement supplement, a serving size of 12 oz is necessarily selected. Therefore, McCleary teaches a range of volumes which may be selected depending on which alcoholic beverage is chosen as the carrier for the brain or nerve enhancement supplement, including 1.5 oz/serving, 2 – 4 oz/serving, 5 oz/serving, 8 – 10 oz/serving, and 12 oz/serving.
The range of alcoholic beverage volumes, 1.5 oz/serving, 2 – 4 oz/serving, 5 oz/serving, 8 – 10 oz/serving, and 12 oz/serving, as disclosed by McCleary, overlaps with the claimed range of about 2 oz/serving to about 32 oz/serving. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
McCleary does not teach the supplement comprises a purine nucleotide.
Van Buren teaches a liquid dietary supplement comprising a therapeutically effective concentration of a nucleotide comprising adenine (i.e., a purine nucleotide) and a pharmacologically acceptable carrier, wherein said nucleotide is capable of promoting wound healing in an animal (Claims 1, 2, and 4). Van Buren teaches purine nucleotides are involved in almost all cellular processes and play a major role in structural, metabolic, energetic, and regulatory functions (p. 4, lines 10 – 13). Van Buren teaches the major purine bases are adenine, guanine, hypoxanthine, and xanthine (p. 5, lines 7 – 8). Van Buren teaches adenine (i.e., a purine nucleotide) supplementation significantly improves wound healing in vivo relative to a non-supplemented diet (p. 31, lines 9 – 18; Figure 1).
McCleary and Van Buren are combinable because they are concerned with the same field of endeavor, namely, dietary supplementation. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have added a nucleotide comprising adenine (i.e., a purine nucleotide), as taught by Van Buren, to the supplement of McCleary because nucleotides comprising adenine (i.e., a purine nucleotides) provide benefits such as wound healing in addition to the brain and nerve enhancement effects in the brain and nerve enhancement supplement of McCleary.
McCleary does not teach the supplement comprises about 0.1 mg to about 1,000 mg of a purine nucleotide.
Van Buren teaches the content of adenine (i.e., a purine nucleotide) in the supplement is preferably 0.34 mg/kg body weight/day to 170 mg/kg body weight/day (p. 16, lines 6 – 11). While the human population exhibits a broad range of adult body weights, as evidenced by Gallup, the average adult body weight in the United States is about 181 lbs (i.e., 82 kg – p. 2, paragraph 2). Therefore, the teachings of Van Buren suggest including adenine (i.e., a purine nucleotide) in an amount of about 28 mg/day to about 13,940 mg/day.
The range of adenine (i.e., a purine nucleotide) content in the supplement, about 28 mg/day to about 13,940 mg/day, as disclosed by Van Buren, overlaps with the claimed range of 0.1 mg to about 1,000 mg. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
While McCleary teaches sweeteners may be included in the brain or nerve enhancement supplement [0245]); McCleary does not teach the supplement comprises steviol glycosides.
IFIC teaches stevia sweeteners are no-calorie sweeteners that can be used to lower one’s intake of added sugars while still providing satisfaction from enjoying the taste of something sweet (p. 1, paragraph 1). IFIC teaches Like other no-calorie sweeteners, stevia sweeteners are intensely sweet. Stevia sweeteners range from being 200-350 times sweeter than sugar, and as such only small amounts of stevia sweeteners are needed to match the sweetness provided by sugar (p. 1, paragraph 2). IFIC teaches stevia sweeteners can be used by food and beverage manufacturers as an ingredient in beverages (such as diet sodas, light or low-sugar juices and flavored waters – p. 1, paragraph 2). IFIC teaches stevia sweeteners are made by extracting steviol glycosides from the leaves of the stevia plant and purifying them to remove some of the bitter attributes found in the crude extract (p. 1, paragraph 4).
McCleary and IFIC are combinable because they are concerned with the same field of endeavor, namely, beverages comprising sweeteners. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included stevia sweetener (i.e., steviol glycosides) as a sweetener, as taught by IFIC in the brain or nerve enhancement supplement of McCleary because stevia sweeteners (i.e., steviol glycosides) are intensely sweet and suitable for use in beverages.
Regarding claim 19, while McCleary does not teach the trimethylglycine the beta-hydroxybutyric acid are present in a ratio of 1.4:1 to 1.6:1 by weight, one of ordinary skill in the art would have adjusted the dosage of trimethylglycine and beta-hydroxybutyric acid during routine optimization to find the supplement with the desired balance of effect on the nervous system. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed weight ratio of trimethylglycine and beta-hydroxybutyric acid, 1.4:1 to 1.6:1, would thus be obvious.
Additionally, the overlapping ranges of the betaine (i.e., trimethylglycine – 750 to 1,500mg) and beta-hydroxybutyric acid (1,000mg) in the modified brain or nerve enhancement supplement of McCleary encompass embodiments wherein the supplement has a ratio of 1.4:1 to 1.6:1 of betaine (i.e., trimethylglycine) and beta-hydroxybutyric acid such as, for example, a brain or nerve enhancement supplement comprising 1,500 mg of betaine and 1,000mg of beta-hydroxybutyric acid would comprise said components in a ratio of 1.5:1.
The range of ratios of betaine (i.e., trimethylglycine) to beta-hydroxybutyric acid, 0.75:1 to 1.5:1, in the modified supplement of McCleary, overlaps with the claimed range of 1.4:1 to 1.6:1. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 20, McCleary does not teach the electrolyte salt comprises from 200 mg/ serving to 400 mg/ serving of sodium, where the sodium is administered as a bicarbonate, citrate, phosphate, or chloride salt.
Cleveland Clinic teaches the body uses bicarbonate to keep your blood pH levels normal (p. 6, Bicarbonate (-)). Cleveland Clinic teaches too little bicarbonate causes acidosis which can cause fatigue, nausea and vomiting, and you will breathe faster and deeper (p. 6, Bicarbonate (-)). Cleveland Clinic teaches too much bicarbonate causes alkalosis which can cause confusion, apathy, arrhythmias and muscle twitching (p. 6, Bicarbonate (-)).
Cleveland Clinic teaches phosphate is a phosphorous-based molecule that’s a key part of transporting chemical compounds and molecules outside your cells and helps your cells metabolize nutrients, and it’s also a key part of molecules called nucleotides, which are the building blocks that make up your DNA (p. 5, Phosphate (-)). Cleveland Clinic teaches too much phosphate typically causes you to experience hypocalcemia because your body tries to use calcium as a substitute for phosphorus (p. 5, Phosphate (-)). Cleveland Clinic teaches not enough phosphate can cause rhabdomyolysis (breakdown of muscle tissue, which can cause severe kidney damage), seizures, reduced heart function and trouble breathing (caused by muscle weakness – p. 5, Phosphate (-)).
Cleveland Clinic teaches chloride is key part of how your cells maintain their internal and external balance of fluid and the body’s natural pH balance (p. 5, Chloride (-)). Cleveland Clinic teaches too much chloride can cause acidosis which can cause nausea, vomiting and fatigue, as well as rapid, deeper breathing and confusion (p. 5, Chloride (-)). Cleveland Clinic teaches too much chloride can cause your blood to become more alkaline, a condition called alkalosis which can cause apathy, confusion, arrhythmias and muscle twitching or loss of control (p. 5, Chloride (-)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included an electrolyte salt blend of sodium where the sodium is administered as a bicarbonate, phosphate, or chloride salt in an amount of 200 mg/ serving to 400 mg/ serving, as taught by Cleveland Clinic in the brain or nerve enhancement supplement of McCleary to provide the necessary amounts of sodium, for healthy body function without causing the side effects of sodium toxicity in combination with the necessary amounts of bicarbonate, phosphate, or chloride without causing the side effects of bicarbonate, phosphate, or chloride toxicity.
McCleary does not teach the electrolyte salt comprises from 200 mg/ serving to 400 mg/ serving of potassium, where the potassium is administered as a bicarbonate, citrate, phosphate, or chloride salt.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included an electrolyte salt blend of potassium where the potassium is administered as a bicarbonate, phosphate, or chloride salt in an amount of 200 mg/ serving to 400 mg/ serving, as taught by Cleveland Clinic in the brain or nerve enhancement supplement to provide the necessary amounts of sodium, for healthy body function without causing the side effects of potassium toxicity in combination with the necessary amounts of bicarbonate, phosphate, or chloride without causing the side effects of bicarbonate, phosphate, or chloride toxicity.
McCleary does not teach the electrolyte salt comprises from 5 mg/ serving to 25 mg/ serving of a bicarbonate, citrate, phosphate, or chloride salt of magnesium.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included an electrolyte salt blend of sodium where the sodium is administered as a bicarbonate, phosphate, or chloride salt in an amount of 5 mg/ serving to 25 mg/ serving, as taught by Cleveland Clinic in the brain or nerve enhancement supplement of McCleary to provide the necessary amounts of magnesium, for healthy body function without causing the side effects of magnesium toxicity in combination with the necessary amounts of bicarbonate, phosphate, or chloride without causing the side effects of bicarbonate, phosphate, or chloride toxicity.
McCleary does not teach the electrolyte salt comprises from 5 mg/ serving to 25 mg/ serving of a bicarbonate, citrate, phosphate, or chloride salt of calcium.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have included an electrolyte salt blend of sodium where the calcium is administered as a bicarbonate, phosphate, or chloride salt in an amount of 5 mg/ serving to 25 mg/ serving of, as taught by Cleveland Clinic in the brain or nerve enhancement supplement of McCleary to provide the necessary amounts of calcium, for healthy body function without causing the side effects of calcium toxicity in combination with the necessary amounts of bicarbonate, phosphate, or chloride without causing the side effects of bicarbonate, phosphate, or chloride toxicity.
Response to Arguments
Applicant's arguments filed November 21, 2025 have been fully considered.
Applicant argues the previous Office Action suggests that a user should ingest the entire MaxiFocus bottle (56 mL) as a single serving, which is contrary to the instructions of the MaxiFocus bottle (p. 8, paragraph 2).
Applicant’s argument has been carefully considered but is moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues a person of ordinary skill in the art would not make such a drastic change to the formula of the MaxiFocus supplement because MaxiFocus cautions “DO NOT EXCEED STATED DAILY DOSE” (p. 9, paragraph 3).
Applicant’s argument has been carefully considered and is persuasive. Therefore, the rejection of claims 1 – 4, 6 – 10, 12 – 16 and 18 – 20 over Victoria Health has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of McCleary.
Applicant argues there is no indication that increasing the trimethylglycine dose would be safe in combination with the other supplements ingredients (p. 9, paragraph 4).
Applicant’s argument has been carefully considered but is moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues implementing the teachings of Schwab would render the supplement of Victoria Health unsatisfactory for its intended use (p. 10, paragraph 1).
Applicant’s argument has been carefully considered but is moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues one of ordinary skill in the art would not have been motivated to increase the magnesium in the MaxiFocus supplement 166 times, as required to reach the instant invention (p. 11, paragraph 7).
Applicant’s argument has been carefully considered but is moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARK JULIA MORENO whose telephone number is (571)272-2337. The examiner can normally be reached 6:30 - 4:30 M - F.
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/L.J.M./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793