Derivative works — US Patent 11760963

Defensive Disclosure Document

Reference Patent: US 11,760,963
Title: Ketogenic beer and alcoholic beverage mixture containing non-racemic ethyl 3-hydroxybutyrate and/or 1,3 butanediol
Publication Date: May 5, 2026
Purpose: To establish prior art against potential future patent applications by disclosing foreseeable variations, extensions, and applications of the core technology described in US patent 11,760,963. This document is intended for public disclosure.

Part 1: Derivative Disclosures Based on a Core D-1,3-Butanediol Beverage

The following disclosures expand upon the core concept of a beverage comprising at least 0.5% by volume of substantially pure D-1,3-butanediol as claimed in US 11,760,963.

1.1. Material & Component Substitution: Alternative Ketogenic Alcohols

Enabling Description: A ketogenic beverage is formulated wherein the D-1,3-butanediol is partially or fully substituted with an alternative non-ethanol, metabolically active diol or triol. Specifically, (2R,4R)-pentanediol is used at a concentration range of 0.5% to 25% by volume. This diol is metabolized in the liver via beta-oxidation to yield ketone bodies. The formulation is stabilized in an aqueous solution buffered with a citrate-phosphate buffer to a pH of 4.5, enhancing shelf-stability and palatability. Additional flavorants and non-nutritive sweeteners, such as erythritol and monk fruit extract, are included to mask the inherent bitterness of the active ingredient.

Diagram:

graph TD
    subgraph Formulation Process
        A[Start: Deionized Water] --> B{Buffer Addition};
        B --> C[Mix until pH 4.5];
        C --> D{Add (2R,4R)-pentanediol};
        D --> E[Mix until dissolved];
        E --> F{Add Flavorants/Sweeteners};
        F --> G[Final Filtration];
        G --> H[Carbonation & Bottling];
    end

1.2. Material & Component Substitution: Self-Emulsifying Delivery System

Enabling Description: A non-aqueous, self-emulsifying ketogenic beverage concentrate is disclosed. The formulation comprises 30-60% D-1,3-butanediol, 20-40% medium-chain triglyceride (MCT) oil (caprylic C8 and capric C10), and 10-20% a non-ionic surfactant system (e.g., Polysorbate 80, Sorbitan monooleate). When this concentrate is added to water or another aqueous beverage, it spontaneously forms a stable oil-in-water nanoemulsion (micelle diameter 50-200 nm), enhancing the bioavailability and absorption rate of both the D-1,3-butanediol and the MCTs. The concentrate can be packaged in single-serving vials for addition to other drinks.

Diagram:

sequenceDiagram
    participant User
    participant Concentrate
    participant Water
    participant Nanoemulsion

    User->>Water: Pours Water into glass
    User->>Concentrate: Adds Concentrate to Water
    Concentrate->>Water: Surfactants activate
    Water->>Nanoemulsion: Forms stable oil-in-water nanoemulsion
    Nanoemulsion-->>User: Ready for consumption

1.3. Operational Parameter Expansion: High-Concentration Supercritical CO2 Extraction

Enabling Description: A process is disclosed for creating a hop-flavored D-1,3-butanediol concentrate. A base solution of 80% D-1,3-butanediol and 20% water is chilled to 2°C. This solution is used as a solvent in a supercritical CO2 extraction process targeting lupulin glands from cryogenically frozen hop cones (e.g., Citra or Mosaic varietals). The process is run at 60 °C and 100 bar pressure. This method selectively extracts hop oils and alpha acids directly into the ketogenic alcohol base without requiring ethanol, creating a potent, beer-like flavoring concentrate that can be diluted to a final beverage concentration of 1-10% by volume.

Diagram:

graph LR
    A[D-1,3-Butanediol/Water Solution] --> C{Chiller};
    B[Cryo-Hops] --> D{Extraction Chamber};
    E[Supercritical CO2] --> D;
    C --> D;
    D --> F{Separator};
    F --> G[Hop-Infused Concentrate];
    F --> H[Spent Hops];
    E --> F;

1.4. Cross-Domain Application: Aerospace Nutrient Solution

Enabling Description: A ketogenic beverage for long-duration spaceflight is disclosed, optimized for microgravity stability and cognitive performance. The formulation consists of 10% D-1,3-butanediol, an electrolyte blend adjusted for spaceflight-induced fluid shifts (higher potassium, lower sodium), and a radiation-protective antioxidant package including astaxanthin and pterostilbene. The liquid is packaged in a zero-G collapsible pouch with a one-way valve. The D-1,3-butanediol serves as a non-glycemic energy source to maintain crew alertness during critical tasks while minimizing metabolic load and CO2 production from respiration. The formulation is verified to be stable against gamma radiation exposure up to 50 Gy.

Diagram:

classDiagram
    class AerospaceBeverage {
        +Double a_D_1_3_Butanediol_percent
        +ElectrolyteProfile m_Electrolytes
        +AntioxidantPackage m_Antioxidants
        +Packaging m_ZeroGPouch
        +verifyRadiationStability(dose)
        +calculateMetabolicLoad()
    }
    class ElectrolyteProfile {
        +Double potassium_mg
        +Double sodium_mg
        +Double magnesium_mg
    }
    class AntioxidantPackage {
        +Double astaxanthin_mcg
        +Double pterostilbene_mg
    }
    AerospaceBeverage *-- ElectrolyteProfile
    AerospaceBeverage *-- AntioxidantPackage

1.5. Cross-Domain Application: Agricultural Metabolic Supplement

Enabling Description: A liquid feed supplement for ruminant livestock (e.g., cattle) designed to mitigate metabolic stress during transport or weaning. The supplement is a water-miscible solution containing 15% D-1,3-butanediol, propylene glycol (as a glucogenic precursor), and cobalt chloride (for Vitamin B12 synthesis). It is administered via the water supply. The D-1,3-butanediol provides a readily available energy source that bypasses traditional glucose pathways, reducing the risk of ketosis (in the pathological sense) and improving energy balance. This leads to reduced weight loss and improved immune function during periods of stress.

Diagram:

stateDiagram-v2
    [*] --> Healthy
    Healthy --> Stress_Event: Transport or Weaning
    Stress_Event --> NegativeEnergyBalance: Reduced Feed Intake
    NegativeEnergyBalance --> PathologicalKetosis: High Fat Mobilization
    NegativeEnergyBalance --> Supplementation: Administer D-1_3_BD
    Supplementation --> EnergyBalanceRestored: Exogenous Ketones
    EnergyBalanceRestored --> Healthy
    PathologicalKetosis --> [*]

1.6. Integration with Emerging Tech: AI-Driven Personalized Formulation

Enabling Description: A system for creating personalized ketogenic beverages. A user provides real-time biomarker data via a wearable sensor (e.g., continuous glucose monitor, breath acetone meter). This data is fed into a cloud-based AI model trained on metabolic response data. The AI calculates an optimal D-1,3-butanediol concentration (from 1% to 15% by volume) and recommends co-administration of additives (e.g., sodium BHB for immediate effect, electrolytes for hydration). The formulation is then mixed on-demand by a countertop appliance that dispenses the components from separate cartridges.

Diagram:

sequenceDiagram
    participant Wearable
    participant UserApp
    participant AI_Cloud
    participant Dispenser

    loop Real-time Data
        Wearable->>UserApp: Stream Glucose/Ketone Data
    end
    UserApp->>AI_Cloud: Send Biomarker Data
    AI_Cloud->>AI_Cloud: Calculate Optimal Formulation
    AI_Cloud->>UserApp: Return Formulation Recipe
    UserApp->>Dispenser: Send Recipe via Bluetooth
    Dispenser->>Dispenser: Mix Ingredients from Cartridges
    Dispenser-->>UserApp: Notify "Beverage Ready"

1.7. The "Inverse" Mode: Rapid-Metabolism Formulation

Enabling Description: A ketogenic beverage designed for rapid onset and clearance, intended for short-term mental focus (e.g., a 60-minute task). The beverage contains a low dose of D-1,3-butanediol (1-3% by volume) combined with metabolic accelerators. Specifically, it includes glucuronolactone and a B-vitamin complex (B3, B5, B6) which are co-factors in the hepatic alcohol dehydrogenase pathway responsible for metabolizing the diol. This formulation is designed to elevate blood ketones to a peak within 30 minutes and return to baseline within 90 minutes, avoiding sustained ketosis.

Diagram:

graph TD
    subgraph Metabolic Pathway
        A(Ingestion) --> B(D-1,3-Butanediol);
        C(B-Vitamins & Glucuronolactone) --> D{Hepatic Metabolism};
        B --> D;
        D -- Alcohol Dehydrogenase --> E(Beta-Hydroxybutyrate);
        E --> F(Rapid Peak Blood Ketones);
        F --> G(Fast Clearance);
    end

Part 2: Derivative Disclosures Based on Combination Claims

These disclosures expand on claims requiring D-1,3-butanediol in combination with other ketogenic agents like BHB salts.

2.1. Material & Component Substitution: Organo-Metallic BHB Chelate

Enabling Description: A beverage is formulated with D-1,3-butanediol (5-10% by volume) and a novel chelated form of D-beta-hydroxybutyrate. Instead of simple mineral salts, a D-BHB-creatine-magnesium chelate is synthesized. This molecule provides BHB, creatine, and magnesium in a single, highly bioavailable complex. The chelation improves solubility, reduces the total mineral load compared to standard salt mixtures, and provides the additional ergogenic benefits of creatine. This creates a synergistic effect for athletic performance applications.

Diagram:

classDiagram
  class Beverage {
    +Double D_1_3_butanediol_concentration
    +ComplexKetoneSource ketone_source
  }
  class BHB_Creatine_Mg_Chelate {
    -String chemicalStructure
    +Double BHB_payload_percent
    +Double creatine_payload_percent
    +Double magnesium_payload_percent
    +calculateMolarRatio()
  }
  Beverage "1" *-- "1" BHB_Creatine_Mg_Chelate : contains

2.2. Integration with Emerging Tech: Blockchain-Verified Purity

Enabling Description: A system for ensuring the quality and isomeric purity of the ketogenic ingredients in the beverage. Each batch of raw D-1,3-butanediol and D-BHB salts is tested by a third-party lab using chiral chromatography. The results, including the enantiomeric excess (e.g., >99.5% D-isomer), are recorded as a transaction on a permissioned blockchain (e.g., Hyperledger Fabric). The final beverage product is labeled with a QR code. When scanned by a consumer, the QR code retrieves the immutable lab results from the blockchain, providing full transparency and verification of the product's composition and quality.

Diagram:

flowchart TD
    A[Raw Material Batch] --> B{3rd Party Lab Test};
    B -- Chiral Chromatography --> C[Certificate of Analysis];
    C --> D{Create Blockchain Transaction};
    D --> E[Record on Hyperledger Fabric];
    F[Beverage Production] --> G{Package & Label};
    E --> G;
    G --> H[Product with QR Code];
    I[Consumer] -- Scans QR Code --> J{Query Blockchain};
    J --> K[Display Purity Data];
    E --> J;

Part 3: Combination Prior Art with Open-Source Standards

3.1. Combination with Open mHealth Data Standard

Disclosure: A health and wellness platform is described that integrates consumption data from a "smart" ketogenic beverage bottle with other health metrics using the Open mHealth schema. The beverage bottle cap contains an NFC tag that records each opening event (timestamped). A mobile application reads the NFC data and logs a consumption event. This event is structured using the Open mHealth omh:physical_activity:kcal_burned and omh:body:blood_glucose schemas to correlate the timing of ketone consumption with its effect on blood glucose and energy expenditure as measured by a separate wearable. This allows for the creation of open-source datasets correlating exogenous ketone intake with metabolic outcomes.

3.2. Combination with OPC Unified Architecture (OPC-UA)

Disclosure: A method for manufacturing the ketogenic beverage of US 11,760,963 in a continuous-flow process controlled by the OPC-UA open-source standard for industrial automation. Inline near-infrared (NIR) and Raman spectroscopy sensors continuously monitor the concentration of D-1,3-butanediol and dissolved minerals in the blending tank. These sensors act as OPC-UA servers, publishing data to an OPC-UA client running on the central control system. The control system adjusts the flow rates of ingredient pumps in real-time to maintain the final product composition within a 0.1% tolerance of the target specification, ensuring high batch-to-batch consistency.

3.3. Combination with the Fast Healthcare Interoperability Resources (FHIR) Standard

Disclosure: A clinical nutrition protocol is described for administering a therapeutic ketogenic beverage in a hospital setting. The beverage, containing D-1,3-butanediol and D-BHB salts as per claim 17 of US 11,760,963, is prescribed by a physician. The prescription and administration details are managed using the FHIR standard. A MedicationRequest resource specifies the exact formulation and dosage schedule. Nurses record each administration event using a MedicationAdministration resource, which links to the patient's electronic health record (EHR). This enables interoperable tracking of the therapeutic intervention and its correlation with clinical outcomes documented in other FHIR resources, such as Observation for blood ketone levels.