Axcess Global Sciences LLC v. Platinium 500

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Axcess Global Sciences, LLC (Utah)
  • Defendant: Platinium 500 Inc. dba Gold Nutra dba Vita Hot Deals (Florida) and Jessica Patino
  • Plaintiff’s Counsel: Workman Nydegger
• Case Identification: 6:24-cv-00001, M.D. Fla., 01/02/2024
• Venue Allegations: Venue is alleged to be proper in the Middle District of Florida because Defendant Platinium is a Florida corporation that resides and has a principal place of business in the district, and Defendant Patino resides in the district.
• Core Dispute: Plaintiff alleges that Defendant’s nutritional supplement products infringe a patent related to beta-hydroxybutyrate (BHB) mixed salt compositions for inducing ketosis.
• Technical Context: The technology concerns exogenous ketone supplements, a product category in the nutritional supplements market designed to help users achieve a state of metabolic ketosis.
• Key Procedural History: The complaint alleges that after initially labeling their products with an infringing formula, Defendants began using false ingredient labels around May 2023 to conceal the ongoing infringement. This allegation, if substantiated, may be central to claims of willful infringement.

Case Timeline

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 10,292,952 - "Mixed salt compositions for maintaining or restoring electrolyte balance while producing elevated and sustained ketosis," issued May 21, 2019

The Invention Explained

• Problem Addressed: The patent's background section describes the difficulty of transitioning into and maintaining a ketogenic state, noting that this process often leads to uncomfortable side effects (the "low-carb flu") and disruptive electrolyte imbalances caused by the diuretic effects of ketosis (’952 Patent, col. 2:5-40).
• The Patented Solution: The invention is a composition of beta-hydroxybutyrate (BHB) mixed with salts of several different cations (e.g., sodium, potassium, calcium, magnesium). This formulation is designed to induce or sustain ketosis by providing an exogenous source of ketones while simultaneously delivering a "biologically balanced set of cationic electrolytes" to counteract the electrolyte depletion that often accompanies the metabolic state (’952 Patent, Abstract; col. 3:60-65).
• Technical Importance: The invention purports to provide the metabolic benefits of ketosis while mitigating the common negative side effects, potentially making a ketogenic lifestyle more sustainable and accessible for a wider range of individuals (’952 Patent, col. 2:56-59).

Key Claims at a Glance

• The complaint asserts infringement of at least representative independent claim 19 (Compl. ¶85).
• The essential elements of independent claim 19 include:
  • A composition for maintaining or restoring electrolyte balance while promoting or sustaining ketosis in a mammal.
  • The composition comprises a beta-hydroxybutyrate (BHB) mixed salt formulated from a plurality of different cations and a single anion, which is BHB.
  • Other anions are omitted from the BHB mixed salt.
  • The cations are formulated to provide a "biologically balanced set of cationic electrolytes."
  • The BHB mixed salt comprises at least three salts selected from a group consisting of sodium BHB, potassium BHB, calcium BHB, and magnesium BHB, with each present in a concentration of 10-70% by weight.
  • The BHB mixed salt is in solid and/or powder form.
• The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

• Product Identification: The Accused Products are a wide range of ketogenic dietary supplements sold by Defendants under various brand names, including "Keto GT," "Regal Keto," "Trim Life Keto," and "Advanced Keto 1500" (Compl. ¶23).
• Functionality and Market Context:
  • The Accused Products are oral supplements, sold as capsules containing a powder, intended for weight management and energy support by promoting ketosis (Compl. ¶36, 87). The complaint alleges that although marketed under different brands, the Accused Products are identical formulations (Compl. ¶30, 84).
  • A central allegation is that around May 2023, Defendants began using "Falsely Labeled Products" which omit BHB from the ingredient list, replacing it with apple cider vinegar and garcinia cambogia, while laboratory testing allegedly reveals the products still contain the infringing BHB formula (Compl. ¶25-26). The complaint provides a visual comparison of an older label identifying a BHB blend and a newer, allegedly false label omitting it (Compl. ¶10).

IV. Analysis of Infringement Allegations

'952 Patent Infringement Allegations

• Identified Points of Contention:
  • Scope Question: The claim requires that "other anions are omitted from the beta-hydroxybutyrate mixed salt." The complaint’s own evidence, a "Supplement Facts" label, lists "Potassium (as chloride)" (Compl. ¶89). The presence of the chloride anion raises the question of whether this limitation is met, as chloride is an "other anion" that does not appear to be "omitted."
  • Evidentiary Question: The complaint does not provide any specific evidence, such as quantitative analysis from the alleged lab testing, to support the allegation that the accused salts meet the "10-70% by weight" limitation for at least three different BHB salts. The infringement allegation for this element appears to be conclusory.

V. Key Claim Terms for Construction

• The Term: "other anions are omitted"

  • Context and Importance: This negative limitation is critical because the Defendant's own product label, as presented in the complaint, appears to disclose the presence of a chloride anion (Compl. ¶89). The viability of the infringement claim may depend on whether the presence of potassium chloride means that "other anions" are not "omitted" from the mixed salt as required by the claim.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (i.e., less strict omission): A party could argue that "omitted from the beta-hydroxybutyrate mixed salt" means that no other anions are part of the BHB salt complex itself, and that the presence of a separate compound like potassium chloride does not violate the limitation. The specification focuses on compositions where BHB is the single anion forming salts with various cations (’952 Patent, col. 4:21-25).
    • Evidence for a Narrower Interpretation (i.e., strict omission): A party could argue the plain meaning requires the final composition to be substantially free of other anions entirely. The patent repeatedly emphasizes formulating salts from "a single anion, wherein the single anion is BHB" (’952 Patent, col. 4:22-23), which may support an interpretation that the entire mixture should not contain other anions like chloride.

• The Term: "biologically balanced set of cationic electrolytes"

  • Context and Importance: This term is central to the patent's purported novelty over prior art and is inherently subjective. Practitioners may focus on this term because its definition will determine the scope of formulations that can be considered infringing.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the goal of avoiding "detrimental health effects associated with imbalanced electrolyte ratios" generally, which could support a functional, effects-based definition (’952 Patent, Abstract).
    • Evidence for a Narrower Interpretation: The patent provides specific, objective examples of what may be considered "balanced." For instance, it suggests formulating the mixed salt so that the molar ratio of sodium to potassium is no greater than 1, and the ratio of calcium to magnesium is no greater than 1 (’952 Patent, col. 7:55-61). It also ties the definition to not exceeding the Recommended Dietary Allowance (RDA) for a given electrolyte (’952 Patent, col. 7:62-65).

VI. Other Allegations

• Indirect Infringement: The complaint alleges inducement, stating Defendants have actual knowledge of their infringement (Compl. ¶92). This claim may be supported by the allegation that Defendants advertise their products using phrases like "Patented Ketones" and "Patented Exogenous Ketones" on their labels, which suggests knowledge of patent protection in this area (Compl. ¶28). The complaint includes screenshots of product marketing that contain these phrases (Compl. ¶11).
• Willful Infringement: Willfulness is alleged based on Defendants' knowledge of the patent (Compl. ¶93). The primary factual support for this is the alleged scheme to change the product labels to remove any mention of BHB, which Plaintiff contends was a deliberate attempt to conceal the ongoing infringement (Compl. ¶25-27).

VII. Analyst’s Conclusion: Key Questions for the Case

• A core issue will be one of claim scope and technical contradiction: can the claim limitation requiring that "other anions are omitted" be met when the complaint’s own evidence shows the accused product contains "Potassium (as chloride)"? The interpretation of this negative limitation may be dispositive for the infringement analysis.
• A key evidentiary question will be whether Plaintiff can produce evidence, beyond the conclusory allegations in the complaint, demonstrating that the accused BHB salts meet the specific "10-70% by weight" concentration ranges required by Claim 19.
• The case may also turn on a question of intent: do the allegations of using "Patented Ketones" in marketing and subsequently changing product labels to hide the infringing ingredients provide sufficient evidence to support the claims of inducement and willful infringement?