Administration Of R-Beta-Hydroxybutyrate And Related Compounds In Humans
Patent No. US12109182 (titled "Administration Of R-Beta-Hydroxybutyrate And Related Compounds In Humans") was filed by Axcess Global Sciences Llc on Jul 2, 2021.
What is this patent about?
’182 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 are known to promote ketosis and weight loss, their high salt content can lead to adverse health effects. Polymers of beta-hydroxybutyrate offer a slower delivery, requiring larger doses to achieve the same effect. Thus, there is a need for improved formulations and delivery methods of beta-hydroxybutyrate.
The underlying idea behind ’182 is to leverage the R-isomer of beta-hydroxybutyrate (R-BHB) in a highly purified form to achieve the desired effects of ketosis and weight management with reduced side effects. The inventors recognized that R-BHB is more bioavailable and effective than the racemic mixture (D,L-BHB) or the L-isomer alone. This allows for lower dosages, minimizing the intake of potentially harmful salts and maximizing the beneficial impact on health.
The claims of ’182 focus on a composition containing a non-racemic mixture of R-beta-hydroxybutyrate and S-beta-hydroxybutyrate , where the R-isomer constitutes approximately 90% to less than 100% of the mixture, and the S-isomer makes up the remainder. The composition is formulated as a pill, tablet, capsule, powder, food product, or beverage. Some claims specify the R-BHB being present as a salt and the free acid, or the inclusion of 1,3-butanediol.
In practice, the invention involves administering a composition with a high concentration of R-BHB. This can be achieved through various delivery methods, such as pills, powders mixed into drinks, or even incorporated into food products. The purified R-BHB is more readily absorbed and utilized by the body, leading to a faster and more pronounced increase in blood ketone levels. This, in turn, promotes fat loss, improves mental acuity, and enhances physical performance.
The differentiation from prior approaches lies in the isomer-specific formulation . Previous methods relied on racemic mixtures of beta-hydroxybutyrate, which contain both the R and L isomers. The inventors discovered that the L-isomer is less effective and may even hinder the beneficial effects of the R-isomer. By using a highly purified R-BHB, the invention overcomes these limitations, providing a more potent and safer way to induce and maintain ketosis and achieve related health benefits.
How does this patent fit in bigger picture?
Technical landscape at the time
In the mid-2010s when ’182 was filed, butyrate and beta-hydroxybutyrate were typically administered orally or intravenously, at a time when systems commonly relied on salt forms to deliver beta-hydroxybutyrate, when hardware or software constraints made precise control over isomer ratios and delivery mechanisms non-trivial.
Novelty and Inventive Step
Claims 21-40 were rejected in a non-final office action. The rejection was based on obviousness-type double patenting over multiple U.S. patents. The prosecution record does NOT describe the technical reasoning or specific claim changes that led to allowance.
Claims
This patent contains 22 claims, of which claims 1, 18, 21, and 22 are independent. The independent claims generally focus on compositions for administering ketone bodies to a subject, specifically relating to non-racemic mixtures of R-beta-hydroxybutyrate and S-beta-hydroxybutyrate. The dependent claims generally elaborate on the specific ratios, components, and forms of the compositions described in the independent claims.
Key Claim Terms New
Definitions of key terms used in the patent claims.
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Date
Description
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US12109182
- Application Number
- US17367206
- Filing Date
- Jul 2, 2021
- Status
- Granted
- Expiry Date
- Apr 29, 2039
- External Links
- Slate, USPTO, Google Patents