DCT

8:23-cv-00779

University Of South Florida Board Of Trustees v. Ancient Brands LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 8:23-cv-00779, M.D. Fla., 04/10/2023
  • Venue Allegations: Venue is alleged to be proper as Defendant is a Florida entity that maintains employees and a regular and established place of business within the Middle District of Florida.
  • Core Dispute: Plaintiffs allege that Defendant’s "Keto Fire" line of nutritional supplements infringes two patents related to chemical compositions for inducing and sustaining a metabolic state of ketosis.
  • Technical Context: The technology lies in the field of nutritional science, specifically exogenous ketone supplements designed to elevate blood ketone levels to provide therapeutic or performance benefits without requiring strict adherence to a ketogenic diet.
  • Key Procedural History: The complaint alleges that Plaintiffs provided Defendant with actual notice of infringement for both asserted patents on or about November 9, 2022, approximately five months prior to the filing of the suit. This pre-suit notice forms the basis for the willfulness allegation regarding one of the patents.

Case Timeline

Date Event
2013-03-19 U.S. Patent No. 10,646,462 Priority Date
2016-03-11 U.S. Patent No. 10,292,952 Priority Date
2019-05-21 U.S. Patent No. 10292952 Issue Date
2020-05-12 U.S. Patent No. 10646462 Issue Date
2022-11-09 Alleged Pre-Suit Notice of Infringement
2023-04-10 Complaint Filing Date

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

U.S. Patent No. 10,646,462 - "Compositions and Methods for Producing Elevated and Sustained Ketosis"

  • Patent Identification: U.S. Patent No. 10,646,462, "Compositions and Methods for Producing Elevated and Sustained Ketosis," issued May 12, 2020.

The Invention Explained

  • Problem Addressed: The patent describes the difficulty and unpleasant side effects (the "low carb flu") associated with transitioning into and sustaining nutritional ketosis via a restrictive diet alone (ʼ462 Patent, col. 5:1-11). It also notes that existing supplemental approaches are suboptimal; for example, administering beta-hydroxybutyrate (BHB) as a simple sodium salt can lead to a harmful "sodium overload" at therapeutic doses (ʼ462 Patent, col. 5:62-65).
  • The Patented Solution: The invention is a composition that combines at least one medium chain fatty acid (or an ester like medium chain triglycerides, MCT) with a beta-hydroxybutyrate (BHB) ketone source, such as a mixture of different BHB mineral salts (ʼ462 Patent, Abstract; col. 6:36-54). This combination is asserted to generate a more rapid, elevated, and sustained level of blood ketones than either component would individually, easing the transition into ketosis.
  • Technical Importance: This approach was designed to make the metabolic benefits of ketosis more accessible by providing a supplemental method to elevate ketones that mitigates both the strict dietary requirements and the side effects of prior supplemental strategies (ʼ462 Patent, col. 4:62-68).

Key Claims at a Glance

  • The complaint asserts dependent claim 4, which incorporates independent claim 1.
  • Independent Claim 1 requires:
    • A composition for inducing ketosis, suppressing appetite, or promoting weight loss in a mammal, comprising therapeutically effective amounts of:
    • at least one medium chain fatty acid or ester thereof; and
    • a beta-hydroxybutyrate monomer salt mixture comprising a plurality of beta-hydroxybutyrate monomer salts with at least two salts selected from a group including sodium, potassium, calcium, and magnesium beta-hydroxybutyrate.
  • Dependent claim 4 further narrows the salt mixture to comprise at least three of sodium, potassium, calcium, or magnesium beta-hydroxybutyrate (’462 Patent, col. 20:34-39).

U.S. Patent No. 10,292,952 - "Mixed Salt Compositions for Maintaining or Restoring Electrolyte Balance While Producing Elevated and Sustained Ketosis"

  • Patent Identification: 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 recognizes that entering and maintaining a ketogenic state disrupts the body's normal electrolyte balance, which can cause fatigue, cramping, and other negative effects (’952 Patent, col. 3:36-47). Administering exogenous ketones in salt form can worsen this problem if the mineral (cation) proportions are not carefully managed (’952 Patent, col. 5:16-25).
  • The Patented Solution: The patent discloses a BHB mixed salt composition specifically formulated to provide a "biologically balanced set of cationic electrolytes" (’952 Patent, Abstract). The key concept is to use a plurality of different cations (e.g., sodium, magnesium, calcium) with BHB as the single anion, while specifically omitting other anions from the salt mixture, thereby delivering ketones while helping to manage electrolyte levels (’952 Patent, col. 4:21-29).
  • Technical Importance: The invention aims to solve a key hurdle in the adoption of ketogenic lifestyles by creating a supplement that not only induces ketosis but also proactively addresses the common problem of electrolyte imbalance (’952 Patent, col. 3:51-55).

Key Claims at a Glance

  • The complaint asserts independent claim 19.
  • Independent Claim 19 requires:
    • A composition for maintaining or restoring electrolyte balance while promoting or sustaining ketosis in a mammal, comprising:
    • a beta-hydroxybutyrate (BHB) mixed salt formulated from multiple different cations and a single BHB anion, where other anions are omitted from the salt, and where the cations provide a "biologically balanced set of cationic electrolytes";
    • the mixed salt comprises at least three salts from the group of sodium BHB, potassium BHB, calcium BHB, and magnesium BHB, with each being present in an amount of 10-70% by weight;
    • the mixed salt is in solid and/or powder form.

III. The Accused Instrumentality

Product Identification

  • The accused products are Defendant's "Keto Fire" nutritional supplements (Compl. ¶1).

Functionality and Market Context

  • The Keto Fire supplement is sold in capsule form and is marketed as a "Ketone activator fueled by exogenous ketones, MCTs and adaptogenic herbs" (Compl. p. 5, Product Image). The "Supplement Facts" panel provided in the complaint lists a proprietary "KetoFIRE Blend" that includes Magnesium Beta-Hydroxybutyrate, Calcium Beta-Hydroxybutyrate, Sodium Beta-Hydroxybutyrate, and Medium Chain Triglycerides (from coconut), alongside various herbal extracts and other ingredients (Compl. ¶13). The product is marketed for promoting energy, weight management, and fat metabolism (Compl. ¶12).

IV. Analysis of Infringement Allegations

'462 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A composition for inducing ketosis, suppressing appetite, or promoting weight loss in a mammal, comprising therapeutically effective amounts of: The Keto Fire product is marketed for promoting healthy energy, weight management, and fat metabolism, aligning with the claimed purposes. ¶12 col. 6:29-35
at least one medium chain fatty acid or ester thereof; and The product's "Supplement Facts" panel explicitly lists "Medium Chain Triglycerides (Coconut)" as an ingredient in its proprietary blend. The complaint provides a visual highlighting this ingredient. ¶20, p. 11 col. 6:36-39
a beta-hydroxybutyrate monomer salt mixture comprising a plurality of beta-hydroxybutyrate monomer salts with at least two beta-hydroxybutyrate monomer salts selected from the group... The product's "Supplement Facts" panel lists "Magnesium Beta-Hydroxybutyrate, Calcium Beta-Hydroxybutyrate, [and] Sodium Beta-Hydroxybutyrate," meeting the requirement for at least two such salts. The complaint provides a visual highlighting these ingredients. ¶21, p. 12 col. 6:40-54
From dependent claim 4: wherein the beta-hydroxybutyrate monomer salt mixture comprises at least three of sodium..., potassium..., calcium..., or magnesium beta-hydroxybutyrate. The product contains sodium, calcium, and magnesium beta-hydroxybutyrate, thereby meeting the three-salt requirement of claim 4. ¶21, p. 12 col. 20:34-39
  • Identified Points of Contention:
    • Scope Questions: The preamble's requirement for "therapeutically effective amounts" may be a point of dispute. A court may have to determine whether the mere presence of the claimed ingredients in the accused product is sufficient, or if infringement requires proof that the quantities are effective for inducing a specific clinical or metabolic state described in the patent.
    • Technical Questions: Does the blend of numerous additional ingredients in the Keto Fire product (e.g., herbal extracts, collagen peptides) alter the function or character of the composition such that it falls outside the scope of the claims, even with the open-ended "comprising" language?

'952 Patent Infringement Allegations

Claim Element (from Independent Claim 19) Alleged Infringing Functionality Complaint Citation Patent Citation
a beta-hydroxybutyrate mixed salt formulated from a plurality of different cations and a single anion, wherein the single anion is beta-hydroxybutyrate, and wherein other anions are omitted from the beta-hydroxybutyrate mixed salt... The product contains BHB salts with multiple cations (Magnesium, Calcium, Sodium). However, the complaint does not address how the product meets the negative limitation "wherein other anions are omitted" in light of its many other ingredients. ¶34 col. 4:21-26
...the cations being formulated so as to provide a biologically balanced set of cationic electrolytes upon administration to a mammal, The complaint alleges this functional limitation is met but does not provide evidence or analysis regarding how the product's formulation achieves a "biologically balanced" state. ¶33 col. 4:26-29
the beta-hydroxybutyrate mixed salt comprising at least three salts selected from the group consisting of: 10-70% by weight of sodium beta-hydroxybutyrate; 10-70% by weight of potassium...; 10-70% by weight of calcium...; and 10-70% by weight of magnesium... The product contains sodium, calcium, and magnesium BHB. The complaint, however, provides no information regarding the weight percentages of these salts to demonstrate they fall within the claimed 10-70% range for each. ¶34 col. 6:45-53
wherein the beta-hydroxybutyrate mixed salt is in solid and/or powder form. The Accused Product is sold in capsules, which contain the ingredients in a powdered form. The complaint includes an image of the capsule bottle. ¶11, p. 5 col. 5:5-7
  • Identified Points of Contention:
    • Evidentiary Questions: The complaint makes a conclusory allegation of infringement but offers no evidence that the individual BHB salts in the Keto Fire product meet the specific 10-70% by weight limitations required by claim 19. This appears to be a significant gap in the infringement allegations as pleaded.
    • Scope Questions: The term "biologically balanced" is subjective and will likely be a central focus of claim construction. Further, the negative limitation "wherein other anions are omitted" raises a critical question: does this apply only to the chemical structure of the salt molecules themselves, or does it mean the overall salt mixture within the final product must be free from other anions, which seems unlikely given the product's complex formulation.

V. Key Claim Terms for Construction

  • Term: "biologically balanced set of cationic electrolytes" (’952 Patent, claim 19)

    • Context and Importance: This functional language is the core of the asserted '952 patent's invention, distinguishing it from simple ketone salt mixtures. The outcome of the infringement analysis for this patent will likely depend heavily on the construction of this term.
    • Intrinsic Evidence for a Broader Interpretation: The specification suggests the goal is to avoid "detrimental health effects" and promote "positive electrolytic effects," language that could support a more general, functional definition (’952 Patent, col. 6:31-36).
    • Intrinsic Evidence for a Narrower Interpretation: The patent provides specific preferred embodiments, such as where "the molar ratio of sodium ions to potassium ions is no greater than 1, and/or such that the molar ratio of calcium ions to magnesium ions in no greater than 1" (’952 Patent, col. 8:55-61). A defendant may argue these ratios define the scope of what is "biologically balanced."

  • Term: "wherein other anions are omitted from the beta-hydroxybutyrate mixed salt" (’952 Patent, claim 19)

    • Context and Importance: Practitioners may focus on this term because it is a negative limitation, and the accused product is a complex mixture containing botanical extracts and other compounds that could introduce other anions.
    • Intrinsic Evidence for a Broader Interpretation (favoring Plaintiff): A plaintiff may argue that this limitation applies only to the salt component itself (i.e., the cations are bound only to BHB anions, not chloride or sulfate), and that the claim's use of "comprising" for the overall composition allows for the presence of other ingredients that are not part of the "mixed salt."
    • Intrinsic Evidence for a Narrower Interpretation (favoring Defendant): A defendant could argue that within the final product, the "mixed salt" is not isolated, and the presence of other ingredients like "Ancient Peat Mineral Complex" or fruit extracts inherently introduces other anions into the effective mixture, meaning they are not "omitted."

VI. Other Allegations

  • Willful Infringement: The complaint alleges that Defendant has willfully infringed the ’462 Patent. This allegation is based on Defendant's alleged "knowledge of the USF Patent or was willfully blind to the USF Patent and the risk of the Defendant’s infringement," stemming from actual notice provided by Plaintiffs on or about November 9, 2022 (Compl. ¶23-24). No allegation of willfulness is made for the ’952 Patent.

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

  • A key evidentiary question will be one of quantitative proof: can Plaintiffs produce evidence, not present in the complaint, demonstrating that the accused product’s ingredients meet the specific 10-70% by-weight ratios required by claim 19 of the ’952 patent?
  • A central issue will be one of definitional scope: can the negative limitation "wherein other anions are omitted" from the '952 patent be met by a complex formulation containing numerous botanical and mineral ingredients, or will the potential presence of other anions from these ingredients place the product outside the claim's scope?
  • A core dispute will concern functional interpretation: what objective, evidentiary standard will the court require to prove that a composition provides "therapeutically effective amounts" (’462 patent) and a "biologically balanced set of cationic electrolytes" (’952 patent), and does the mere listing of ingredients suffice to meet this burden at later stages of litigation?