Non-Racemic Beta-Hydroxybutyrate Compounds And Compositions Enriched With The R-Enantiomer And Methods Of Use
Patent No. US12090129 (titled "Non-Racemic Beta-Hydroxybutyrate Compounds And Compositions Enriched With The R-Enantiomer And Methods Of Use") was filed by Axcess Global Sciences Llc on Jul 3, 2023.
What is this patent about?
’129 is related to the field of nutritional supplements and metabolic enhancement, specifically compositions designed to elevate ketone body levels in a subject. The background involves the challenges of achieving and maintaining ketosis through diet alone, including the difficulty of transitioning into a ketogenic state and the electrolyte imbalances that can occur. Prior art includes racemic mixtures of beta-hydroxybutyrate (BHB) and compositions containing only the R-enantiomer, with some discouraging the use of the S-enantiomer.
The underlying idea behind ’129 is to provide a more effective ketogenic composition by using a non-racemic mixture of R-beta-hydroxybutyrate and S-beta-hydroxybutyrate . The key insight is that while the R-enantiomer is the naturally occurring form and provides immediate energy, including a controlled amount of the S-enantiomer can offer additional benefits, such as prolonged ketosis, modulation of R-beta-hydroxybutyrate metabolism, and other metabolic effects, contrary to the prevailing view that it is ineffective or harmful.
The claims of ’129 focus on a composition containing a non-racemic mixture of R-beta-hydroxybutyrate and S-beta-hydroxybutyrate , where the R-enantiomer is present in a higher proportion (more than 50% and less than 100% by enantiomeric equivalents) than the S-enantiomer (less than 50% and more than 0% by enantiomeric equivalents). The composition includes at least one R-beta-hydroxybutyrate salt or ester, at least one S-beta-hydroxybutyrate salt or ester, and at least one of R- or S-beta-hydroxybutyric acid, and is provided in a dietetically or pharmaceutically acceptable form.
In practice, the invention allows for a more nuanced approach to ketosis. The higher concentration of the R-enantiomer provides a rapid increase in ketone body levels, facilitating a quicker transition into ketosis. The presence of the S-enantiomer, however, is believed to modulate the metabolism of the R-enantiomer and glucose, potentially prolonging the ketogenic state and offering other metabolic benefits. The inclusion of both salt and acid forms of BHB further enhances absorption rates and bioavailability, while also improving taste and reducing the need for additional acids.
This approach differentiates itself from prior solutions that either use racemic mixtures (less effective) or focus solely on the R-enantiomer (potentially missing out on the benefits of the S-enantiomer). By carefully controlling the ratio of R- and S-beta-hydroxybutyrate, the composition aims to optimize both the speed of ketosis induction and the duration and metabolic effects of the ketogenic state. The inclusion of salts, esters, and free acids allows for fine-tuning of the pharmacokinetics and electrolyte balance of the composition, addressing some of the common challenges associated with ketogenic diets.
How does this patent fit in bigger picture?
Technical landscape at the time
In the late 2010s when ’129 was filed, ketosis was typically induced through dietary restrictions or fasting, at a time when exogenous ketone supplementation was emerging as a method to rapidly elevate blood ketone levels, when hardware or software constraints made precise control of enantiomeric ratios in pharmaceutical or nutritional compositions non-trivial, and when systems commonly relied on racemic mixtures or single enantiomer formulations rather than optimized non-racemic mixtures.
Novelty and Inventive Step
Claims were rejected for obviousness-type double patenting over several related patents. The rejection was based on the examiner's view that the claimed compositions were not patentably distinct from those in the prior patents. The prosecution record does NOT describe the technical reasoning or specific claim changes that led to allowance.
Claims
This patent includes 24 claims, with independent claims 1, 12, and 17. The independent claims are directed to compositions for administering ketone bodies comprising non-racemic mixtures of R-beta-hydroxybutyrate and S-beta-hydroxybutyrate. The dependent claims generally elaborate on the specific components, ratios, and forms of the compositions described in the independent claims, as well as kits containing the compositions.
Key Claim Terms New
Definitions of key terms used in the patent claims.
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Date
Description
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US12090129
- Application Number
- US18217864
- Filing Date
- Jul 3, 2023
- Status
- Granted
- Expiry Date
- Mar 27, 2038
- External Links
- Slate, USPTO, Google Patents