Axcess Global Sciences LLC v. Sales Venue Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Axcess Global Sciences, LLC (Utah)
  • Defendant: Sales Venue, Inc. dba Snap Supplements (Delaware), Vladimir Nesterenco (Washington), and Max Mikhaylenko (Washington)
  • Plaintiff’s Counsel: Workman Nydegger
• Case Identification: 3:23-cv-05665, W.D. Wash., 07/24/2023
• Venue Allegations: Venue is asserted based on the Defendants’ residence, regular and established place of business, employees, and substantial acts of alleged infringement within the Western District of Washington.
• Core Dispute: Plaintiff alleges that Defendant’s Snap BHB Keto Burn dietary supplement infringes patents related to mixed salt compositions of beta-hydroxybutyrate (BHB) for inducing nutritional ketosis.
• Technical Context: The technology lies in the field of exogenous ketone supplements, which are designed to help consumers achieve the metabolic state of ketosis without strictly adhering to a ketogenic diet.
• Key Procedural History: The complaint alleges that Plaintiff and its licensees have marked their products in accordance with patent law, which may be relevant to the calculation of damages. No other significant procedural events are mentioned in the complaint.

Case Timeline

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

U.S. Patent No. 11,241,403 - Beta-hydroxybutyrate mixed salt compositions and methods of use (Issued Feb. 8, 2022)

The Invention Explained

• Problem Addressed: The patent describes the difficulty of transitioning into and maintaining a state of nutritional ketosis, a process often accompanied by negative side effects like fatigue and headaches (the "low-carb flu") caused by electrolyte imbalances that result from diuretic effects. (’403 Patent, col. 2:10-20, 2:45-51).
• The Patented Solution: The invention is a composition of beta-hydroxybutyrate (BHB) salts designed not only to exogenously raise blood ketone levels but also to deliver a "biologically balanced set of cationic electrolytes." (’403 Patent, Abstract; col. 2:25-31). By providing various mineral salts of BHB (e.g., calcium, magnesium, sodium, potassium), the composition aims to induce ketosis while simultaneously mitigating the electrolyte imbalances that make the transition difficult for many individuals. (’403 Patent, col. 2:21-31).
• Technical Importance: This approach seeks to lower the barrier to entry for individuals pursuing a ketogenic lifestyle by addressing the well-known physiological challenges associated with the initial transition period. (’403 Patent, col. 2:52-61).

Key Claims at a Glance

• The complaint asserts independent claim 1. (Compl. ¶25).
• Essential elements of Claim 1 include:
  • A composition for increasing ketone level in a subject.
  • Comprising a plurality of beta-hydroxybutyrate salts, which must include at least one salt of calcium or magnesium.
  • The plurality must also include at least one "other" salt selected from a group including sodium, potassium, calcium, magnesium, or amino acid salts of beta-hydroxybutyrate.
  • The salts of calcium and/or magnesium must comprise at least 20% of the total weight of all beta-hydroxybutyrate salts.
  • The composition must be in a solid and/or powder form.
  • The composition must be "free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof."

U.S. Patent No. 11,020,362 - Beta-hydroxybutyrate mixed salt compositions and methods of use (Issued June 1, 2021)

The Invention Explained

• Problem Addressed: The patent identifies the same technical problem as its related ’403 Patent: the difficulty and negative side effects of transitioning into a ketogenic state, particularly the electrolyte imbalances that occur. (’362 Patent, col. 4:8-17, 4:45-51).
• The Patented Solution: The invention proposes a composition of exogenous BHB salts that provides ketones to fuel the body and, through the salt formulation, delivers a balanced set of electrolytes to counteract depletion. (’362 Patent, Abstract; col. 4:61-64). This dual-function approach is intended to make sustaining ketosis more tolerable.
• Technical Importance: The technology offers a method to bypass some of the harshest side effects of entering ketosis, potentially increasing consumer adoption and adherence to ketogenic protocols. (’362 Patent, col. 4:52-61).

Key Claims at a Glance

• The complaint asserts independent claim 1. (Compl. ¶36).
• Essential elements of Claim 1 include:
  • A composition for increasing blood ketone level in a subject.
  • Comprising at least three beta-hydroxybutyrate salts selected from a group consisting of sodium, potassium, calcium, and magnesium beta-hydroxybutyrate.
  • The composition must be in a solid and/or powder form.
  • The composition must be "free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof."

III. The Accused Instrumentality

Product Identification

• The accused product is "Snap BHB Keto Burn," a dietary supplement. (Compl. ¶3).

Functionality and Market Context

• The product is sold in capsules containing a powder blend and is marketed as a supplement that "Promotes ketosis" and helps "turn fat to fuel." (Compl. p. 6). The complaint identifies the product's "Ketosis Kickstarter Blend" as containing Sodium Beta-Hydroxybutyrate, Calcium Beta-Hydroxybutyrate, and Magnesium Beta-Hydroxybutyrate, as well as listing Potassium Chloride among its ingredients. (Compl. p. 6). The complaint includes a screenshot of the product's "Supplement Facts" label, which lists these ingredients. (Compl. p. 6). The product is allegedly sold through Defendants' own website and major third-party retailers. (Compl. ¶15).

IV. Analysis of Infringement Allegations

’403 Patent Infringement Allegations

• Identified Points of Contention:
  • Technical Question: A primary point of dispute may be the "at least 20% by total weight" limitation. The complaint alleges this element is met but provides only the product's ingredient list, not a quantitative chemical analysis. The court will require extrinsic evidence to substantiate this claim.
  • Scope Question: The complaint does not address how the product's inclusion of "Potassium Chloride," rather than potassium beta-hydroxybutyrate, might relate to the overall patented concept of a balanced electrolyte salt composition. While the presence of Sodium BHB may satisfy the literal claim language, the difference in the potassium source could become relevant during claim construction arguments about the invention's purpose.

’362 Patent Infringement Allegations

• Identified Points of Contention:
  • Technical Question: Infringement of the ’362 Patent appears more direct on the face of the complaint, as it requires "at least three" salts from the list (which the product label shows) and lacks the quantitative weight percentage of the ’403 Patent. The central question will be evidentiary: confirming that the product formulation matches its label.

V. Key Claim Terms for Construction

• The Term: "free of medium chain fatty acids"
• Context and Importance: This negative limitation is present in the asserted claims of both patents. Its interpretation is critical because the presence of even small amounts of these substances could allow the Defendant to argue non-infringement. Practitioners may focus on this term because the line between being "free of" a substance and containing non-functional trace amounts is a common subject of claim construction disputes.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation (allowing trace amounts): The specification discusses medium chain triglycerides (MCTs) as an alternative ketone precursor that can be combined with the BHB salts. (’362 Patent, col. 9:10-18). This context suggests that the "free of" limitation is intended to distinguish the invention from compositions that intentionally include MCTs for their ketogenic effect, which may support a construction where "free of" means "not intentionally added in functional amounts."
  • Evidence for a Narrower Interpretation (requiring absolute absence): The claim language itself is absolute and does not provide for a threshold or de minimis exception. A patentee could argue that if the inventors meant to allow for trace amounts, they would have used qualifying language such as "substantially free of."

VI. Other Allegations

• Indirect Infringement: The complaint alleges inducement of infringement, stating Defendants "induc[e] others to make, use, offer for sale, and/or sell Snap BHB." (Compl. ¶27, ¶38). The factual basis appears to be that Defendants' marketing and instructions encourage consumers to use the product for its intended purpose of promoting ketosis, which constitutes the infringing use. (Compl. p. 6).
• Willful Infringement: Willfulness is alleged based on the assertion that "Defendants use the precise, patented formula of BHB." (Compl. ¶28, ¶39). The complaint does not allege that Defendants had pre-suit knowledge of the patents, which is a high bar for proving willfulness.

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

1. A key evidentiary question will be one of quantitative proof: can the Plaintiff produce chemical analysis demonstrating that the accused product's formulation meets the "at least 20% by total weight" limitation of the ’403 Patent, or will the case turn solely on the less stringent "at least three salts" requirement of the ’362 Patent?
2. A core issue will be one of definitional scope: how will the court construe the negative limitation "free of medium chain fatty acids"? The outcome of this construction—whether it means an absolute absence or merely the lack of an intentionally added functional amount—will be critical to the infringement analysis for both patents.
3. The viability of the willfulness claim will depend on whether Plaintiff can establish that Defendants had actual knowledge of the asserted patents prior to the lawsuit's filing. The complaint's current allegations, which tie willfulness to the act of infringement itself, may not be sufficient to meet the standard for pre-suit willful infringement.