Beta-Hydroxybutyrate Mixed Salt Compositions And Methods Of Use
Patent No. US11241403 (titled "Beta-Hydroxybutyrate Mixed Salt Compositions And Methods Of Use") was filed by Axcess Global Sciences Llc on Mar 11, 2021.
What is this patent about?
’403 is related to the field of nutritional supplements, specifically compositions designed to induce or sustain ketosis . Ketosis is a metabolic state where the body primarily uses ketone bodies, rather than glucose, for energy. This state is achieved through fasting, a low-carbohydrate diet, or supplementation. However, transitioning into and maintaining ketosis can be challenging due to electrolyte imbalances and other side effects.
The underlying idea behind ’403 is to provide a balanced beta-hydroxybutyrate (BHB) salt composition that promotes ketosis while mitigating electrolyte imbalances. The invention recognizes that simply supplementing with BHB salts can disrupt the body's electrolyte balance, leading to adverse effects. Therefore, the core insight is to formulate a mixture of BHB salts with specific ratios of cations like sodium, potassium, calcium, and magnesium to support ketosis without exacerbating electrolyte deficiencies or excesses.
The claims of ’403 focus on a composition containing a plurality of BHB salts. These salts include at least one of calcium BHB or magnesium BHB, and at least one other BHB salt selected from sodium BHB, potassium BHB, calcium BHB, magnesium BHB, or amino acid salts of BHB. The claims specify that the composition is in solid or powder form and excludes medium-chain fatty acids. Some claims require a minimum percentage of calcium and/or magnesium BHB, or a greater total weight of calcium and magnesium BHB salts than sodium and potassium BHB salts.
In practice, the invention works by providing exogenous ketones in the form of BHB salts, which the body can readily use for energy, thus inducing or sustaining ketosis. The specific ratios of cations in the BHB salt mixture are designed to replenish electrolytes lost during ketosis and prevent imbalances that can lead to fatigue, muscle cramps, and other adverse effects. The inclusion of amino acid salts of BHB allows for higher BHB dosing without excessive electrolyte loading.
The differentiation from prior approaches lies in the balanced electrolyte profile of the BHB salt composition. Previous methods of inducing ketosis, such as strict ketogenic diets or supplementation with single BHB salts, often led to electrolyte imbalances. By carefully controlling the ratios of sodium, potassium, calcium, and magnesium, the ’403 composition aims to provide a more complete and balanced approach to ketosis, minimizing side effects and improving overall tolerability. The addition of anticaking agents further improves the manufacturability and handling of the composition.
How does this patent fit in bigger picture?
Technical landscape at the time
In the mid-2010s when ’403 was filed, at a time when nutritional supplements were typically formulated to provide a specific benefit, such as weight loss or energy enhancement. Systems commonly relied on single-ingredient or simple combinations of ingredients to achieve these effects. Hardware or software constraints made precise control over electrolyte balance in supplement formulations non-trivial.
Novelty and Inventive Step
The examiner approved the application because the claims are directed to a novel beta-hydroxybutyrate mixed salt composition in solid or powdered form that increases blood ketone levels. The composition includes at least calcium or magnesium beta-hydroxybutyrate and at least one other salt selected from sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, and magnesium beta-hydroxybutyrate; and an amino acid salt of beta-hydroxybutyrate, wherein the beta-hydroxybutyrate salt is comprised of at least 20% by total weight of calcium beta-hydroxybutyrate and/or magnesium beta-hydroxybutyrate, and wherein the composition is free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof. Although a similar composition was taught by Vlahakos, Vlahakos fails to teach, suggest or render obvious any composition comprising a plurality of beta-hydroxybutyrate salts comprising at least one of calcium beta-hydroxybutyrate and magnesium butyrate in an amount that is at least 20% by total weight of the beta-hydroxybutyrate salts.
Claims
This patent contains 20 claims, with independent claims numbered 1, 13, 16, and 19. The independent claims are directed to compositions for increasing ketone levels in a subject, focusing on different combinations and percentages of beta-hydroxybutyrate salts. The dependent claims generally specify further details, limitations, or additional components of the compositions described in the independent claims.
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Date
Description
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US11241403
- Application Number
- US17198634
- Filing Date
- Mar 11, 2021
- Status
- Granted
- Expiry Date
- Mar 9, 2037
- External Links
- Slate, USPTO, Google Patents