DCT

1:22-cv-01528

University Of South Florida Board Of Trustees v. Perfect Keto LLC

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I. Executive Summary and Procedural Information

Case Timeline

Date Event
2013-03-19 Priority Date for ’420, ’577, and ’462 Patents
2015-09-22 U.S. Patent No. 9,138,420 Issues
2016-03-11 Priority Date for ’952, ’362, and ’403 Patents
2017-06-13 U.S. Patent No. 9,675,577 Issues
2019-05-21 U.S. Patent No. 10,292,952 Issues
2020-05-12 U.S. Patent No. 10,646,462 Issues
2021-06-01 U.S. Patent No. 11,020,362 Issues
2022-02-08 U.S. Patent No. 11,241,403 Issues
2022-11-22 Complaint Filed

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

U.S. Patent No. 9,138,420 - Compositions and Methods for Producing Elevated and Sustained Ketosis

  • Patent Identification: U.S. Patent No. 9,138,420, "Compositions and Methods for Producing Elevated and Sustained Ketosis," issued September 22, 2015 (’420 Patent).

The Invention Explained

  • Problem Addressed: The patent describes the difficulty and negative physiological effects of transitioning into a state of ketosis through diet alone, such as the "low carb flu" and the long period required to show measurable results, which create significant barriers for individuals seeking the benefits of a ketogenic lifestyle (Compl. ¶9; ’462 Patent, col. 5:1-15).
  • The Patented Solution: The invention is a composition combining two types of ketogenic precursors: mineral salts of beta-hydroxybutyrate (BHB) for rapid elevation of blood ketones, and medium chain triglycerides (MCT) or other medium chain fatty acid esters that provide a more sustained source for the body to produce its own ketones. This combination is intended to provide a faster and more tolerable method for inducing and sustaining ketosis than either component alone (’420 Patent, Abstract; ’462 Patent, col. 6:25-41).
  • Technical Importance: This approach aims to make the metabolic benefits of ketosis more accessible by providing an oral supplement that bypasses the strict dietary compliance and physiological stress typically required to achieve and maintain elevated ketone levels (’462 Patent, col. 6:25-34).

Key Claims at a Glance

  • The complaint asserts dependent claim 3, which relies on independent claim 1 (Compl. ¶21).
  • Independent Claim 1:
    • A composition, comprising:
    • at least one medium chain fatty acid or ester thereof in an amount between about 5 grams and about 50 grams; and
    • at least one beta-hydroxybutyrate compound in an amount between about 2 grams and about 50 grams, wherein the at least one beta-hydroxybutyrate compound is comprised of a beta-hydroxybutyrate salt.
  • Dependent Claim 3:
    • The composition of claim 1, wherein the beta-hydroxybutyrate compound comprises a salt mixture comprising a plurality of sodium, potassium, calcium, or magnesium beta-hydroxybutyrate.

U.S. Patent No. 9,675,577 - Compositions and Methods for Producing Elevated and Sustained Ketosis

  • Patent Identification: U.S. Patent No. 9,675,577, "Compositions and Methods for Producing Elevated and Sustained Ketosis," issued June 13, 2017 (’577 Patent).

The Invention Explained

  • Problem Addressed: The ’577 Patent addresses the same technical problem as the ’420 Patent: the difficulty and adverse symptoms associated with achieving nutritional ketosis through diet, fasting, or exercise alone (Compl. ¶9; ’462 Patent, col. 5:1-15).
  • The Patented Solution: The invention claims a method for promoting or sustaining ketosis in a mammal. The method involves administering the same combination of ketogenic precursors—a medium chain fatty acid or ester thereof and a BHB monomer salt—in specific daily amounts to achieve elevated blood ketone levels (’577 Patent, col. 20:5-18).
  • Technical Importance: By claiming the method of administration in daily dosages, the patent seeks to cover the therapeutic or supplemental regimen for using these compositions to manage a subject's metabolic state (’577 Patent, col. 20:5-18).

Key Claims at a Glance

  • The complaint asserts dependent claim 2, which relies on independent claim 1 (Compl. ¶32).
  • Independent Claim 1:
    • A method of promoting or sustaining ketosis in a mammal, comprising:
    • administering at least one medium chain fatty acid or ester thereof in an amount between about 5 grams and about 50 grams per day for at least one day; and
    • administering at least one beta-hydroxybutyrate compound, where the compound is a beta-hydroxybutyrate monomer salt in an amount between about 2 grams and about 50 grams per day for at least one day.
  • Dependent Claim 2:
    • The method of claim 1, wherein the beta-hydroxybutyrate compound comprises one or more salts from a specified group, including sodium, potassium, calcium, and magnesium beta-hydroxybutyrate.

Multi-Patent Capsules

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 (’462 Patent).
  • Technology Synopsis: This patent, part of the same family as the ’420 and ’577 patents, claims a composition for inducing ketosis, suppressing appetite, or promoting weight loss. The composition includes a medium chain fatty acid (or ester) and a BHB monomer salt mixture comprising a plurality of different BHB salts (’462 Patent, col. 20:8-25).
  • Asserted Claims: Claim 4 (dependent on Claim 1) (Compl. ¶44).
  • Accused Features: The "Perform: Keto Pre-Workout Drink" and "Keto Nootropic" products are accused of infringing by allegedly containing both MCTs and a mixture of at least three BHB salts (sodium, calcium, and magnesium) (Compl. ¶¶43, 47, p. 24).

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 (’952 Patent).
  • Technology Synopsis: This patent addresses the electrolyte imbalances that can occur during ketosis. It claims a composition of a BHB "mixed salt" formulated from multiple different cations (e.g., sodium, potassium, calcium, magnesium) but only a single anion (beta-hydroxybutyrate) to provide a "biologically balanced set of cationic electrolytes" (’952 Patent, Abstract, col. 15:3-19). The claimed composition is in a solid or powder form.
  • Asserted Claims: Claim 19 (Compl. ¶56).
  • Accused Features: The "Exogenous Ketones Drink Mix," "Perform: Keto Pre-Workout Drink," and "Keto Nootropic" products are accused of infringing by allegedly containing a powder-form mixture of at least three BHB salts (sodium, calcium, and magnesium) (Compl. ¶¶55, 59, p. 28).

U.S. Patent No. 11,020,362 - Beta-hydroxybutyrate Mixed Salt Compositions and Methods of Use

  • Patent Identification: U.S. Patent No. 11,020,362, "Beta-hydroxybutyrate Mixed Salt Compositions and Methods of Use," issued June 1, 2021 (’362 Patent).
  • Technology Synopsis: This patent claims a composition for increasing blood ketone levels that comprises at least three different BHB salts (selected from sodium, potassium, calcium, and magnesium). A key aspect of the invention is the explicit exclusion of medium chain fatty acids, distinguishing it from the USF patents (’362 Patent, col. 15:40-52).
  • Asserted Claims: Claim 1 (Compl. ¶69).
  • Accused Features: The "Exogenous Ketones Drink Mix" is accused of infringing by allegedly containing at least three BHB salts (sodium, calcium, and magnesium) while being free of medium chain fatty acids (Compl. ¶¶68, 74, p. 37).

U.S. Patent No. 11,241,403 - Beta-hydroxybutyrate Mixed Salt Compositions and Methods of Use

  • Patent Identification: U.S. Patent No. 11,241,403, "Beta-hydroxybutyrate Mixed Salt Compositions and Methods of Use," issued February 8, 2022 (’403 Patent).
  • Technology Synopsis: This patent claims a BHB salt composition with specific ratios of cations. The claimed composition must contain calcium and/or magnesium BHB, at least one other BHB salt, and have a greater total weight of calcium and magnesium BHB salts than sodium and potassium BHB salts. Like the ’362 Patent, it is explicitly free of medium chain fatty acids (’403 Patent, col. 13:40-14:5).
  • Asserted Claims: Claim 13 (Compl. ¶83).
  • Accused Features: The "Exogenous Ketones Drink Mix" and "Keto BHB Capsules" are accused of infringing by allegedly containing a mixture of calcium, magnesium, and sodium BHB salts where the combined weight of calcium and magnesium salts is greater than the weight of sodium salts, and which is free of medium chain fatty acids (Compl. ¶¶82, 87, p. 43).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Defendant's ketogenic dietary supplements, specifically the "Exogenous Ketones Drink Mix," "Keto BHB Capsules," "Perform: Keto Pre-Workout Drink," and "Keto Nootropic" (collectively, the "Accused Products") (Compl. ¶¶12, 20, 31, 43, 55, 68, 82).

Functionality and Market Context

  • The complaint alleges these products are oral supplements marketed and sold to consumers for the purpose of inducing or supporting a state of ketosis (Compl. ¶13). The products are described as containing exogenous ketones, specifically BHB, and in some cases MCTs, to "help reach ketosis," "boost ketone levels," and provide energy (Compl. ¶¶13-16). The complaint provides images of the products' marketing materials and "Supplement Facts" labels, which list the ingredients and their amounts per serving. For example, the "Keto Nootropic" label lists "MCT (Medium Chain Triglycerides) 5000mg" as well as Magnesium, Sodium, and Calcium Beta-Hydroxybutyrate, each at 1200mg per serving (Compl. p. 9). This "Supplement Facts" label for the Keto Nootropic product serves as a key piece of evidence for the infringement allegations (Compl. p. 11).

IV. Analysis of Infringement Allegations

’420 Patent Infringement Allegations

Claim Element (from Independent Claim 1 and Dependent Claim 3) Alleged Infringing Functionality Complaint Citation Patent Citation
1. A composition, comprising: The accused "Keto Nootropic" product is alleged to be a composition sold as a dietary supplement. ¶22, p. 11 col. 6:37-38
at least one medium chain fatty acid or ester thereof in an amount between about 5 grams and about 50 grams; The product's "Supplement Facts" label discloses "MCT (Medium Chain Triglycerides) 5000mg" per serving, which is equivalent to 5 grams. ¶22, p. 11 col. 6:37-39
at least one beta-hydroxybutyrate compound in an amount between about 2 grams and about 50 grams, wherein the at least one beta-hydroxybutyrate compound is comprised of a beta-hydroxybutyrate salt. The product's label discloses a total of 3.6 grams (3600mg) of BHB salts per serving (1200mg each of Magnesium, Sodium, and Calcium Beta-Hydroxybutyrate). ¶22, p. 12 col. 6:40-43
3. ...wherein the at least one beta-hydroxybutyrate compound comprises a salt mixture comprising a plurality of... The product allegedly contains a mixture of three distinct BHB salts. ¶22, p. 12 col. 7:1-6
sodium beta-hydroxybutyrate, ... calcium beta-hydroxybutyrate, or magnesium beta-hydroxybutyrate. The product's label explicitly lists Sodium Beta-Hydroxybutyrate, Calcium Beta-Hydroxybutyrate, and Magnesium Beta-Hydroxybutyrate as ingredients. ¶22, p. 12 col. 7:1-6

’577 Patent Infringement Allegations

Claim Element (from Independent Claim 1 and Dependent Claim 2) Alleged Infringing Functionality Complaint Citation Patent Citation
1. A method of promoting or sustaining ketosis in a mammal, comprising: The accused "Keto Nootropic" product is marketed with instructions for consumption by users to promote cognitive function and provide energy, allegedly promoting ketosis. ¶¶16, 36 col. 8:51-54
administering at least one medium chain fatty acid or ester thereof in an amount between about 5 grams and about 50 grams per day for at least one day; The product contains 5 grams of MCTs per serving, and the complaint alleges that consuming one serving constitutes a daily administration. ¶34, p. 16 col. 14:8-13
administering at least one beta-hydroxybutyrate compound, where the...compound is beta-hydroxybutyrate monomer salt in an amount between about 2 grams and about 50 grams per day for at least one day. The product contains 3.6 grams of BHB salts per serving, and the complaint alleges that consuming one serving constitutes a daily administration. ¶34, p. 17 col. 14:13-18
2. ...wherein the at least one beta-hydroxybutyrate compound comprises one or more of a beta-hydroxy butyrate sodium salt, ...calcium salt, ...magnesium salt... The product's label lists Sodium, Calcium, and Magnesium Beta-Hydroxybutyrate as ingredients, which are administered upon consumption. ¶34, p. 17 col. 14:19-28

Identified Points of Contention

  • Scope Questions: For the method claims of the ’577 Patent, a central question may be whether the product's "serving size" constitutes the claimed "amount...per day." The analysis will depend on whether the product instructions or typical consumer use patterns establish that one serving is a daily dose.
  • Technical Questions: The infringement allegations rely entirely on the product's "Supplement Facts" label as depicted in the complaint. A key evidentiary question will be whether the actual composition of the Accused Products matches the label, and whether the listed "MCT" ingredient meets the claim construction of "medium chain fatty acid or ester thereof."

V. Key Claim Terms for Construction

The Term: "administering...per day" (from ’577 Patent, Claim 1)

  • Context and Importance: This term is critical for the method claims, as infringement hinges on whether the Defendant's products are used in a manner that delivers the claimed dosage within a daily period. The complaint's theory equates a single "serving size" with the "per day" limitation, which may become a central point of dispute.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discusses administering the composition "once per day, twice per day, or three times per day" (’462 Patent, col. 8:46-48), which suggests that the total amount administered in a day, regardless of the number of doses, is what matters. This could support an argument that even if a serving is less than the claimed daily amount, multiple servings could meet the limitation.
    • Evidence for a Narrower Interpretation: The patent does not explicitly define "per day." A defendant may argue that without specific instructions to consume a certain amount daily, a "serving size" is merely a suggestion and does not equate to an infringing "administering...per day" step required by the claim.

The Term: "medium chain fatty acid or ester thereof" (from ’420 Patent, Claim 1)

  • Context and Importance: The infringement allegation relies on the ingredient "MCT (Medium Chain Triglycerides)" meeting this limitation. Practitioners may focus on this term because the precise chemical makeup of the "MCT" used in the accused product could be disputed relative to the scope of "fatty acid or ester thereof" as defined by the patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification provides a broad list of examples, including "medium chain triglycerides," "coconut oil," "palm kernel oil," and various isolated fatty acids (e.g., caprylic, capric acid), suggesting the term is intended to be inclusive (’462 Patent, col. 7:35-50).
    • Evidence for a Narrower Interpretation: The claims require an amount "between about 5 grams and about 50 grams." A defendant could argue that the specific type of MCT used has a different potency or definition than what is enabled by the specification, or that the "about 5 grams" limitation is not met if the MCT powder contains other excipients that reduce the active ingredient amount below 5 grams.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement of the ’577 Patent. The basis for this allegation is that Defendants provide "instructions...to consumers regarding the use of the Accused Products," specifically through the "supplement facts and product instructions," which allegedly cause consumers to directly infringe the patented method (Compl. ¶36).
  • Willful Infringement: The complaint alleges willful infringement for all asserted patents. The basis for willfulness is the allegation that Defendants received "actual notice of its infringement from the Plaintiffs" and continued their allegedly infringing activities with knowledge of the patents or willful blindness to the risk of infringement (Compl. ¶¶25-26, 37-38, 49-50, 63, 76-77, 90-91).

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

  • A core issue will be one of claim scope and proof: Does the product information on a "Supplement Facts" label, as presented in the complaint, suffice to demonstrate that the composition of the accused products falls within the specific quantitative ranges required by the claims (e.g., "between about 5 grams and about 50 grams")? This raises the evidentiary question of how the actual, as-sold product composition will be proven.
  • A key legal question for the method claims will be one of infringing action: Can infringement of a method claim requiring administration of a dose "per day" be established based on a product's "serving size" recommendation, and what level of proof is required to show that consumers perform this allegedly infringing administration?
  • The case presents a question of technological distinction: With patents covering compositions with MCTs ('420, '577, '462) and patents covering compositions explicitly without MCTs ('362, '403), the dispute will likely involve a detailed chemical analysis of each accused product to determine which, if any, patent category it falls into, raising the possibility that a single product cannot infringe both sets of patents.