Administration Of R-Beta-Hydroxybutyrate And Related Compounds In Humans

Patent No. US12128020 (titled "Administration Of R-Beta-Hydroxybutyrate And Related Compounds In Humans") was filed by Axcess Global Sciences Llc on Feb 29, 2024.

What is this patent about?

’020 is related to the field of nutritional supplements and pharmaceuticals, specifically compositions designed to induce or maintain ketosis and provide related health benefits. The background acknowledges that while beta-hydroxybutyrate salts can promote ketosis and weight loss, excessive salt intake can be detrimental. Polymers of beta-hydroxybutyrate offer a slower delivery, requiring larger doses.

The underlying idea behind ’020 is to provide a more effective and tolerable method for administering beta-hydroxybutyrate to achieve various health benefits. This involves using specific isomers of beta-hydroxybutyrate, such as the R-beta-hydroxybutyrate form, in combination with other compounds like amino acids, fatty acids, or even substances like caffeine, to enhance the desired effects while minimizing potential side effects associated with high salt intake.

The claims of ’020 focus on a beta-hydroxybutyrate composition for oral ingestion as a beverage, dietary supplement, or food product, designed to increase blood ketone levels. The composition includes a liquid carrier (water, milk, etc.), D-beta-hydroxybutyrate (comprising D-beta-hydroxybutyric acid and optionally salts or esters), and R-1,3-butanediol .

In practice, the invention involves formulating a palatable and easily consumable product containing R-beta-hydroxybutyrate, potentially in salt, ester, or complex form, along with other ingredients to boost its effectiveness. For example, combining R-beta-hydroxybutyrate with short-chain triglycerides or amino acids like leucine can lead to a synergistic increase in ketone levels. The inclusion of R-1,3-butanediol is also key to the formulation.

The differentiation from prior approaches lies in the specific use of R-beta-hydroxybutyrate, which the patent argues is more bioavailable and effective than the D,L form, allowing for lower dosages and reduced salt intake. Furthermore, the combination with other compounds like short-chain fatty acids or amino acids, and the inclusion of R-1,3-butanediol, aims to optimize ketone production and utilization, leading to improved weight management, cognitive function, and overall health benefits compared to simply administering beta-hydroxybutyrate salts alone.

How does this patent fit in bigger picture?

Technical landscape at the time

In the mid-2010s when ’020 was filed, beta-hydroxybutyrate was typically administered as a salt to induce ketosis, at a time when systems commonly relied on oral or intravenous delivery rather than more complex formulations. Hardware or software constraints made precise control over isomer ratios and delivery rates non-trivial.

Novelty and Inventive Step

The claims were rejected in a non-final office action. The rejections were based on obviousness-type double patenting over several US patents and a Chinese patent application. The examiner indicated that the claims were not patentably distinct from the cited references. No claims were allowed.

Claims

This patent contains 23 claims, with independent claims numbered 1, 15, and 21. The independent claims generally focus on a beta-hydroxybutyrate composition formulated for oral ingestion to increase blood ketone levels, comprising a liquid carrier, D-beta-hydroxybutyrate, and R-1,3-butanediol. The dependent claims generally define specific amounts of D-beta-hydroxybutyrate, types of salts or esters, additional additives, or exclusions of certain components.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
D-beta-hydroxybutyrate
(Claim 1, Claim 15, Claim 21)
“Beta-hydroxybutyrate (e.g., R-beta-hydroxybutyrate, L-beta-hydroxybutyrate, and/or D,L-beta-hydroxybutyrate) may include beta-hydroxybutyrate salts and/or beta-hydroxybutyrate esters. For example, R-beta-hydroxybutyrate may include less than approximately 10 percent, less than approximately 5 percent, or less than approximately 1 percent L-beta-hydroxybutyrate.”A form of beta-hydroxybutyrate that includes D-beta-hydroxybutyric acid and optionally one or more D-beta-hydroxybutyrate salts or esters.
Increase blood ketone level
(Claim 1, Claim 15, Claim 21)
“In various implementations, compounds such as butyrate, beta-hydroxybutyrate and/or related compounds (e.g., derivatives, esters, polymers, etc.) can be administered alone or in combination with one or more other compounds. In some implementations, blood ketone levels and/or blood glucose levels may be reduced and/or maintained within a predetermined range when a pharmaceutically effective amount of one or more compounds are administered.”The purpose of the beta-hydroxybutyrate composition is to elevate the concentration of ketones in the blood of a subject.
Liquid carrier
(Claim 1, Claim 15, Claim 21)
“In various implementations, a composition for maintaining or increasing weight loss may include approximately 0.5 g to approximately 15 g of R-beta-hydroxybutyrate, one or more flavorings, one or more vitamins, one or more minerals, one or more binders, and/or one or more liquid carriers. The liquid carrier may include water.”A liquid that is at least one of water, milk, drinkable liquid, coconut water, watermelon water, or electrolyte water, and serves as a vehicle for oral delivery of the beta-hydroxybutyrate composition.
R-1,3-butanediol
(Claim 1, Claim 15, Claim 21)
“In some implementations, beta-hydroxybutyrate may be administered with 1,3-butanediol, ethyl acetoacetate, ethyl beta-hydroxybutyrate.”A compound included in the beta-hydroxybutyrate composition.
Sodium D-beta-hydroxybutyrate
(Claim 21)
“For example, beta-hydroxybutyrate (e.g., R-beta-hydroxybutyrate, L-beta-hydroxybutyrate, and/or D,L-beta-hydroxybutyrate) may include beta-hydroxybutyrate salts, beta-hydroxybutyrate esters, beta-hydroxybutyrate sodium salt (e.g., sodium beta-hydroxybutyrate), beta-hydroxybutyrate potassium salt (e.g., potassium beta-hydroxybutyrate), beta-hydroxybutyrate calcium salt (e.g., calcium beta-hydroxybutyrate), beta-hydroxybutyrate magnesium salt (e.g., magnesium beta-hydroxybutyrate), beta-hydroxybutyrate lithium salt (e.g., lithium beta-hydroxybutyrate), sodium beta-hydroxybutyrate, arginine beta-hydroxybutyrate, lysine beta-hydroxybutyrate, histidine beta-hydroxybutyrate, ornithine beta-hydroxybutyrate, creatine beta-hydroxybutyrate, agmatine beta-hydroxybutyrate, or citrulline beta-hydroxybutyrate, other appropriate organic salts that include beta-hydroxybutyrate, and/or combinations thereof.”A salt form of D-beta-hydroxybutyrate, specifically the sodium salt.

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US12128020

AXCESS GLOBAL SCIENCES LLC
Application Number
US18591994
Filing Date
Feb 29, 2024
Status
Granted
Expiry Date
Apr 19, 2037
External Links
Slate, USPTO, Google Patents