Beta-Hydroxybutyrate Mixed Salt Compositions And Methods Of Use

Patent No. US11020362 (titled "Beta-Hydroxybutyrate Mixed Salt Compositions And Methods Of Use") was filed by Axcess Global Sciences Llc on Dec 19, 2019.

What is this patent about?

’362 is related to the field of nutritional supplements, specifically compositions designed to induce or sustain ketosis in a subject. Ketosis, a metabolic state where the body primarily uses ketone bodies for energy instead of glucose, is achieved through fasting, intense exercise, or a low-carbohydrate diet. However, transitioning into and maintaining ketosis can be challenging due to side effects like electrolyte imbalances and the "low-carb flu."

The underlying idea behind ’362 is to provide a balanced blend of beta-hydroxybutyrate (BHB) salts that not only elevates ketone levels but also mitigates the electrolyte imbalances commonly associated with ketogenic diets. The invention recognizes that administering BHB salts, while effective for inducing ketosis, can disrupt electrolyte balance due to the introduction of additional cations. By carefully selecting and proportioning different BHB salts, the composition aims to deliver a biologically balanced set of cationic electrolytes.

The claims of ’362 focus on a composition containing at least three BHB salts selected from sodium, potassium, calcium, and magnesium beta-hydroxybutyrate. The composition is presented in a solid or powder form, or as a tablet, capsule, powder, food product, food additive, drink product, drink additive, vitamin fortified food or drink, or mouth spray. Critically, the claimed compositions explicitly exclude medium chain fatty acids (MCTs) and their derivatives.

In practice, the invention allows individuals to achieve and maintain ketosis more easily and comfortably. By providing a balanced electrolyte profile alongside the ketone bodies, the composition minimizes the negative side effects associated with electrolyte imbalances, such as fatigue, muscle cramps, and dizziness. The exclusion of MCTs suggests a focus on directly delivering ketone bodies rather than relying on the body to produce them from fatty acids, potentially offering a more immediate and controllable ketogenic effect.

The differentiation from prior approaches lies in the specific combination and balance of BHB salts. While previous ketogenic supplements might have included BHB salts, they may not have addressed the issue of electrolyte balance as comprehensively. By formulating the composition with a blend of sodium, potassium, calcium, and magnesium BHB salts, the invention aims to provide a more holistic solution that supports both ketosis and overall electrolyte health, without relying on MCTs for sustained ketogenesis.

How does this patent fit in bigger picture?

Technical landscape at the time

In the mid-2010s when ’362 was filed, at a time when nutritional supplements were typically formulated as powders, capsules, or liquids, and when achieving and sustaining ketosis often involved strict dietary control, systems commonly relied on exogenous ketones to quickly elevate blood ketone levels. At that time, electrolyte balance was recognized as important for overall health, but balancing electrolytes in ketogenic supplements was non-trivial due to the need to deliver sufficient ketones without causing electrolyte imbalances.

Novelty and Inventive Step

The examiner approved the claims because the invention is directed to a novel beta-hydroxybutyrate mixed salt composition in solid or powdered form. This composition increases blood ketone levels in a subject and includes at least three beta-hydroxybutyrate salts selected from sodium, potassium, calcium, and magnesium beta-hydroxybutyrate. While a prior art reference teaches a similar ketogenic composition, it does not teach, suggest, or render obvious the instant composition in solid or powdered form comprising at least three beta-hydroxybutyrate salts.

Claims

This patent contains 22 claims, with independent claims numbered 1, 12, and 15. The independent claims generally focus on compositions containing at least three beta-hydroxybutyrate salts for increasing ketone levels in a subject. The dependent claims generally elaborate on the specific formulations, ratios, additional components, and forms of the compositions described in the independent claims.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Beta-hydroxybutyrate salts
(Claim 1, Claim 12, Claim 15)
“The compound “beta-hydroxybutyrate,” also known as (3-hydroxybutyrate, 3-hydroxybutyrate, βHB, BHB, or beta-hydroxybutyrate, is the deprotonated form of beta-hydroxybutyric acid, which is a hydroxycarboxylic acid having the general formula CH3CH2OHCH2COOH. When X is a hydrogen, the compound is beta-hydroxybutyric acid. When X is a metal ion or an amino cation, the compounds is a beta-hydroxybutyrate salt.”Salts formed from beta-hydroxybutyric acid and a cation, where the cation can be a metal ion or an amino cation.
Calcium beta-hydroxybutyrate
(Claim 1, Claim 12, Claim 15)
“The compound “beta-hydroxybutyrate,” also known as (3-hydroxybutyrate, 3-hydroxybutyrate, βHB, BHB, or beta-hydroxybutyrate, is the deprotonated form of beta-hydroxybutyric acid, which is a hydroxycarboxylic acid having the general formula CH3CH2OHCH2COOH. When X is a hydrogen, the compound is beta-hydroxybutyric acid. When X is a metal ion or an amino cation, the compounds is a beta-hydroxybutyrate salt.”A salt formed from beta-hydroxybutyric acid and a calcium cation.
Magnesium beta-hydroxybutyrate
(Claim 1, Claim 12, Claim 15)
“The compound “beta-hydroxybutyrate,” also known as (3-hydroxybutyrate, 3-hydroxybutyrate, βHB, BHB, or beta-hydroxybutyrate, is the deprotonated form of beta-hydroxybutyric acid, which is a hydroxycarboxylic acid having the general formula CH3CH2OHCH2COOH. When X is a hydrogen, the compound is beta-hydroxybutyric acid. When X is a metal ion or an amino cation, the compounds is a beta-hydroxybutyrate salt.”A salt formed from beta-hydroxybutyric acid and a magnesium cation.
Potassium beta-hydroxybutyrate
(Claim 1, Claim 12, Claim 15)
“The compound “beta-hydroxybutyrate,” also known as (3-hydroxybutyrate, 3-hydroxybutyrate, βHB, BHB, or beta-hydroxybutyrate, is the deprotonated form of beta-hydroxybutyric acid, which is a hydroxycarboxylic acid having the general formula CH3CH2OHCH2COOH. When X is a hydrogen, the compound is beta-hydroxybutyric acid. When X is a metal ion or an amino cation, the compounds is a beta-hydroxybutyrate salt.”A salt formed from beta-hydroxybutyric acid and a potassium cation.
Sodium beta-hydroxybutyrate
(Claim 1, Claim 12, Claim 15)
“The compound “beta-hydroxybutyrate,” also known as (3-hydroxybutyrate, 3-hydroxybutyrate, βHB, BHB, or beta-hydroxybutyrate, is the deprotonated form of beta-hydroxybutyric acid, which is a hydroxycarboxylic acid having the general formula CH3CH2OHCH2COOH. When X is a hydrogen, the compound is beta-hydroxybutyric acid. When X is a metal ion or an amino cation, the compounds is a beta-hydroxybutyrate salt.”A salt formed from beta-hydroxybutyric acid and a sodium cation.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
4:22-cv-04080Jun 16, 2022Axcess Global Sciences, LLC v. Top Notch Nutrition Inc.

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US11020362

AXCESS GLOBAL SCIENCES LLC
Application Number
US16720211
Filing Date
Dec 19, 2019
Status
Granted
Expiry Date
Mar 9, 2037
External Links
Slate, USPTO, Google Patents