DCT
1:24-cv-00189
Axcess Global Sciences LLC v. Vital Health Intl LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Axcess Global Sciences, LLC (Utah) and Pruvit Ventures, Inc. (Texas)
- Defendant: Vital Health International LLC (Wyoming)
- Plaintiff’s Counsel: Crowley | Fleck; Workman Nydegger
- Case Identification: 1:24-cv-00189, D. Wyo., 09/23/2024
- Venue Allegations: Plaintiff alleges venue is proper in the District of Wyoming because Defendant resides, is registered to do business, maintains a principal office and registered agent, and allegedly committed a substantial portion of the infringing acts within the district.
- Core Dispute: Plaintiffs allege that Defendant’s KETOKAFE-BHB dietary supplement infringes three U.S. patents related to beta-hydroxybutyrate (BHB) mixed salt compositions designed to induce and sustain ketosis while managing electrolyte balance.
- Technical Context: The technology lies in the field of exogenous ketone supplements, which aim to provide the metabolic benefits of a ketogenic diet without strict dietary adherence by directly elevating ketone levels in the blood.
- Key Procedural History: Plaintiff Pruvit Ventures, Inc. is identified as the exclusive sublicensee of the asserted patents in the relevant field of use. The complaint alleges that Defendant was provided with actual notice of the asserted patents prior to the lawsuit's filing.
Case Timeline
| Date | Event |
|---|---|
| 2016-03-11 | Earliest Priority Date for ’952, ’362, and ’403 Patents |
| 2019-05-21 | U.S. Patent No. 10,292,952 Issues |
| 2021-06-01 | U.S. Patent No. 11,020,362 Issues |
| 2022-02-08 | U.S. Patent No. 11,241,403 Issues |
| 2024-03-22 | Date Plaintiff Received Accused Product for Third-Party Testing |
| 2024-09-23 | Complaint Filed |
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 (’952 Patent)
The Invention Explained
- Problem Addressed: The patent’s background section describes that transitioning to and maintaining a state of nutritional ketosis is challenging and often leads to electrolyte imbalances, causing symptoms commonly known as the "low-carb flu," such as fatigue, muscle cramping, and headaches (’952 Patent, col. 3:31-40).
- The Patented Solution: The invention is a beta-hydroxybutyrate (BHB) composition formulated as a mixed salt with a plurality of different cations (e.g., sodium, potassium, calcium, magnesium). This approach is designed to deliver BHB to induce ketosis while simultaneously providing a "biologically balanced set of cationic electrolytes" to help prevent or mitigate the electrolyte imbalances associated with ketosis (’952 Patent, Abstract; col. 4:20-25).
- Technical Importance: By addressing the negative side effects of electrolyte disruption, the invention sought to make ketogenic lifestyles more tolerable and sustainable for a broader population (’952 Patent, col. 3:4-8, 50-55).
Key Claims at a Glance
- The complaint asserts independent claim 19 (’952 Patent, claim 19; Compl. ¶27).
- Essential elements of Claim 19 include:
- A composition for maintaining or restoring electrolyte balance while promoting or sustaining ketosis.
- The composition comprises a "beta-hydroxybutyrate mixed salt" with multiple different cations and a single anion (beta-hydroxybutyrate), where other anions are "omitted."
- The cations are formulated to provide a "biologically balanced set of cationic electrolytes."
- The mixed salt comprises at least three salts selected from a group including sodium, potassium, calcium, and magnesium BHB, with each present in a concentration of 10-70% by weight.
- The mixed salt is in a solid and/or powder form.
- The complaint does not explicitly reserve the right to assert other claims, though this is common practice in litigation.
U.S. Patent No. 11,020,362 - "Beta-hydroxybutyrate mixed salt compositions and methods of use," issued June 1, 2021 (’362 Patent)
The Invention Explained
- Problem Addressed: The patent addresses the same general problem as the ’952 Patent: the difficulty and adverse physiological effects, including electrolyte disruption, associated with achieving and maintaining a state of ketosis (’362 Patent, col. 2:7-17).
- The Patented Solution: The invention is a composition for increasing blood ketone levels that comprises at least three different BHB salts. A key feature of the claimed solution is that the composition is explicitly "free of medium chain fatty acids... and glycerides or other esters thereof," distinguishing it from supplements that use medium-chain triglycerides (MCTs) as a ketone precursor (’362 Patent, Abstract; col. 7:1-9).
- Technical Importance: This approach offers a method to elevate ketone levels using only BHB salts, thereby avoiding the use of MCTs, which can cause gastrointestinal distress in some individuals and are not always desired in a ketogenic supplement (’362 Patent, col. 8:54-65).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶46).
- Essential elements of Claim 1 include:
- A composition for increasing blood ketone level in a subject.
- The composition comprises at least three BHB salts selected from sodium, potassium, calcium, and magnesium BHB.
- The composition is in solid and/or powder form.
- The composition is "free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof."
Multi-Patent Capsule: U.S. Patent No. 11,241,403 - "Beta-hydroxybutyrate mixed salt compositions and methods of use," issued February 8, 2022 (’403 Patent)
Technology Synopsis
The ’403 Patent claims a composition for increasing ketone levels comprising a specific plurality of BHB salts. The formulation must include at least one salt from the group of calcium BHB and magnesium BHB, and at least one "other" BHB salt from a list that includes sodium, potassium, calcium, and magnesium BHB. Critically, the claims require that the calcium and/or magnesium BHB salts constitute at least 20% of the total weight of the BHB salts in the composition (’403 Patent, Abstract; claim 1).
Asserted Claims
The complaint asserts independent claim 1 (Compl. ¶64).
Accused Features
The KETOKAFE-BHB product is accused of infringement because it allegedly contains a blend of sodium, calcium, and magnesium BHB salts where the combined calcium and magnesium salts meet the 20% weight threshold (Compl. ¶¶63, 68).
III. The Accused Instrumentality
Product Identification
The accused instrumentality is the "KETOKAFE-BHB" dietary supplement (Compl. ¶13).
Functionality and Market Context
The KETOKAFE-BHB product is a powder supplement described as "Gourmet Dark Roast Coffee with Beta-Hydroxybutyrate" (Compl. p. 5, product image). The product's ingredient list identifies a "Beta-Hydroxybutyrate Blend 500 mg" containing Calcium Beta-Hydroxybutyrate, Magnesium Beta-Hydroxybutyrate, and Sodium Beta-Hydroxybutyrate (Compl. p. 9, supplement facts image). The product is intended to be mixed with a liquid for consumption to aid the body in achieving nutritional ketosis (Compl. ¶11; p. 5, suggested use). The complaint alleges the product is marketed, sold, and imported in the United States and distributed from Defendant's headquarters in Wyoming (Compl. ¶¶13-15).
IV. Analysis of Infringement Allegations
'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 cations being formulated so as to provide a biologically balanced set of cationic electrolytes... | The product contains BHB salts with multiple cations (Ca+, Na+, Mg+) and is alleged to be a composition for promoting ketosis and managing electrolyte balance, consistent with the claim's preamble. | ¶29-30 | col. 4:20-25 |
| 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 beta-hydroxybutyrate; 10-70% by weight of calcium beta-hydroxybutyrate; and 10-70% by weight of magnesium beta-hydroxybutyrate, | The product's ingredient list and third-party lab testing allegedly show the presence of calcium, magnesium, and sodium beta-hydroxybutyrate salts, which are three salts from the claimed Markush group. | ¶26, ¶31 | col. 5:40-44 |
| wherein the beta-hydroxybutyrate mixed salt is in solid and/or powder form. | The Accused Product is sold and advertised as a powder-form dietary supplement. The complaint includes a photograph of the product packaging showing a powdered mix. | ¶32 | col. 4:5-7 |
Identified Points of Contention (’952 Patent)
- Scope Question: The claim requires a "biologically balanced set of cationic electrolytes." The complaint presents lab results as evidence of the product's composition (Compl. ¶26), but the definition of "biologically balanced" is not defined by a simple quantitative measure and will likely be a central point of dispute requiring claim construction. A defendant may argue its formulation does not meet the patent’s criteria for being "balanced."
- Scope Question: The claim requires that "other anions are omitted from the beta-hydroxybutyrate mixed salt." The accused product contains instant coffee and silicon dioxide (Compl. p. 9, ingredients list). This raises the question of whether anions present in these other ingredients fall within the scope of the "omitted" limitation, which will turn on how narrowly the court construes the phrase "from the beta-hydroxybutyrate mixed salt."
'362 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| at least three beta-hydroxybutyrate salts selected from: sodium beta-hydroxybutyrate; potassium beta-hydroxybutyrate; calcium beta-hydroxybutyrate; and magnesium beta-hydroxybutyrate; | The product's "Supplement Facts" panel and independent lab testing allegedly confirm the presence of sodium, calcium, and magnesium beta-hydroxybutyrate. | ¶45, ¶49 | col. 7:1-9 |
| wherein the composition is in solid and/or powder form, | The Accused Product is sold as a powder supplement intended to be mixed into a beverage. | ¶50 | col. 4:10-12 |
| wherein the composition is free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof. | The complaint alleges infringement of this negative limitation, supported by the product's ingredient list, which does not name any medium-chain fatty acids or triglycerides. The complaint includes an image of the ingredient list as evidence. | ¶50 | col. 8:54-65 |
Identified Points of Contention (’362 Patent)
- Technical Question: The claim requires the composition to be "free of medium chain fatty acids." The complaint's evidence is the product's ingredient list (Compl. p. 20). The primary question is evidentiary: what level of proof is required to demonstrate the absence of a substance? A defendant could challenge whether the product is truly "free" of such compounds, potentially raising issues of trace amounts or contaminants not disclosed on the label.
V. Key Claim Terms for Construction
Term: "biologically balanced set of cationic electrolytes" (’952 Patent, Claim 19)
- Context and Importance: This term is qualitative and potentially subjective. Its construction is critical because infringement of the '952 patent hinges on whether the accused product's specific combination of sodium, calcium, and magnesium salts meets this standard. Practitioners may focus on this term because its potential ambiguity could be a basis for a non-infringement or invalidity defense (indefiniteness).
- Intrinsic Evidence for a Broader Interpretation: The specification describes the problem as avoiding the issues of single-electrolyte supplements (’952 Patent, col. 3:5-9). This context may support an interpretation where any combination of multiple electrolytes that mitigates these known issues could be considered "balanced."
- Intrinsic Evidence for a Narrower Interpretation: Claim 20 of the patent recites specific molar ratios ("wherein the molar ratio of sodium ions to potassium ions is no greater than 1, and wherein the molar ratio of calcium ions to magnesium ions is no greater than 1"). A party could argue these ratios, though not in claim 19, inform the meaning of "biologically balanced" and imply a more restrictive definition.
Term: "free of medium chain fatty acids" (’362 Patent, Claim 1)
- Context and Importance: As a negative limitation, the definition of "free of" is crucial. The dispute will center on whether this requires absolute absence or something less. This is important as many complex commercial products may contain trace, undeclared substances.
- Intrinsic Evidence for a Broader Interpretation: A party could argue "free of" means not intentionally added as a functional ingredient, allowing for incidental or background levels of the substance without violating the claim.
- Intrinsic Evidence for a Narrower Interpretation: The patent repeatedly distinguishes the invention from prior art that uses MCTs (’362 Patent, col. 8:54-65). This purpose—to provide an MCT-free alternative—may support a stricter construction, meaning either completely absent or below a standard limit of analytical detection.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement to infringe all three patents. The stated basis is that Defendant provides the Accused Products with instructions that lead customers to use them in an infringing manner (e.g., by mixing the powder with water and consuming it) (Compl. ¶¶ 34, 52, 70). The complaint further alleges that Defendant had actual knowledge of the patents based on pre-suit notice (Compl. ¶¶ 23, 42, 60).
- Willful Infringement: The complaint alleges willful infringement for all asserted patents, claiming this case is exceptional. The basis for willfulness is Defendant's alleged continuation of infringing activities after receiving actual notice of the patents and its alleged infringement (Compl. ¶¶ 35, 53, 71).
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this dispute will likely depend on the court's decisions on the following key questions:
- A core issue will be one of definitional scope: can the term "biologically balanced set of cationic electrolytes" in the ’952 patent be construed with sufficient clarity to be enforceable, and does the accused product's formulation meet that definition? The answer will likely depend heavily on expert testimony regarding what a person of ordinary skill in the art would have understood the term to mean at the time of the invention.
- A second central question is one of quantitative proof: for the ’403 patent, which requires at least 20% of the BHB salts by weight to be calcium and/or magnesium based, the case will involve a factual battle over chemical composition. The dispute will focus on the reliability of the parties' respective lab testing and whether the accused product's formulation consistently and precisely falls within the claimed percentage range.
- Finally, an evidentiary question will be one of proving a negative: for the ’362 patent, what level of evidence is sufficient to establish that the accused product is "free of medium chain fatty acids"? This will require the court to determine if an ingredient label is sufficient or if more rigorous chemical analysis is necessary to meet the patent's negative limitation.