Axcess Global Sciences v. McKim

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Axcess Global Sciences, LLC (Utah)
  • Defendant: Randall McKim dba NATURAL PURE dba VITALPUREORGANICS (Utah)
  • Plaintiff’s Counsel: Workman Nydegger
• Case Identification: 2:23-cv-00937, D. Utah, 12/29/2023
• Venue Allegations: Venue is alleged to be proper in the District of Utah because the Defendant resides in the district, has a principal place of business in the district, and has allegedly committed a substantial portion of the infringing acts within the district.
• Core Dispute: Plaintiff alleges that Defendant’s various ketogenic dietary supplement products infringe two patents related to specific mixed-salt formulations of Beta-Hydroxybutyrate (BHB).
• Technical Context: The technology concerns exogenous ketone supplements designed to help a user’s body achieve and sustain a state of nutritional ketosis, a metabolic process with applications in weight loss and nutrition.
• Key Procedural History: Both patents-in-suit are subject to terminal disclaimers, which may limit their effective patent term to that of an earlier-expiring, related patent. The complaint does not mention any prior litigation or administrative proceedings involving the asserted patents.

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's background describes the difficulty of transitioning into and maintaining a ketogenic state, noting that the process can cause detrimental physiological effects such as lethargy, hypoglycemia (the "low-carb flu"), and electrolyte imbalances resulting from the diuretic effects of ketosis ('403 Patent, col. 1:49 - 2:56).
• The Patented Solution: The invention is a composition of beta-hydroxybutyrate (BHB) salts intended to induce or sustain ketosis in a subject. The composition is formulated with a specific mix of different mineral salts of BHB to provide a "biologically balanced set of cationic electrolytes," which aims to mitigate the electrolyte imbalances that can occur when entering ketosis ('403 Patent, Abstract; col. 3:1-13).
• Technical Importance: The formulation aims to allow for the therapeutic benefits of ketosis without the negative side effects often associated with the transition, and without introducing new imbalances from excessive intake of a single electrolyte like sodium ('403 Patent, col. 7:8-20).

Key Claims at a Glance

• The complaint asserts independent claim 1 ('403 Patent, col. 15:40 - 16:2).
• Essential elements of claim 1 include:
  • A composition for increasing ketone level in a subject.
  • Comprising a plurality of beta-hydroxybutyrate (BHB) salts, which must include:
    • At least one BHB salt selected from calcium BHB and/or magnesium BHB.
    • At least one other BHB salt selected from a group including sodium BHB, potassium BHB, calcium BHB, magnesium BHB, and amino acid salts of BHB.
  • The BHB salts must comprise at least 20% by total weight of calcium BHB and/or magnesium BHB.
  • The composition is in a 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.
• The complaint does not explicitly reserve the right to assert dependent claims.

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

The Invention Explained

• Problem Addressed: Similar to the '403 patent, the '362 patent addresses the challenge of entering and sustaining ketosis, particularly the electrolyte imbalances that arise from the metabolic shift and associated diuretic effects ('362 Patent, col. 1:49 - 2:56).
• The Patented Solution: The patent describes a composition comprising a mix of at least three different BHB mineral salts. This formulation is designed to provide exogenous ketones to raise blood ketone levels while simultaneously delivering a balanced set of electrolytes to counteract the negative side effects of initiating ketosis ('362 Patent, Abstract; col. 3:1-13).
• Technical Importance: By providing a blend of specific BHB salts, the invention seeks to make the benefits of ketosis more accessible and sustainable by avoiding the "low-carb flu" and preventing the health risks associated with imbalanced electrolyte ratios ('362 Patent, col. 7:8-20).

Key Claims at a Glance

• The complaint asserts independent claim 1 ('362 Patent, col. 15:38 - 16:3).
• Essential elements of claim 1 include:
  • A composition for increasing blood ketone level in a subject.
  • Comprising at least three BHB salts selected from: sodium BHB, potassium BHB, calcium BHB, and magnesium BHB.
  • The composition is in a 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.
• The complaint does not explicitly reserve the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

• The complaint identifies at least 33 distinct products, including "Optimal Max Keto," "One Shot Keto," "Advanced Weight Loss Keto," and "Keto XP," among many others (collectively, the "Accused Products") (Compl. ¶¶ 4-5, pp. 2-6). The complaint alleges that although marketed under different brands, each of the Accused Products is made with the same concentrations of the same ingredients (Compl. ¶¶ 55, 73).

Functionality and Market Context

• The Accused Products are oral dietary supplements sold in capsule form (Compl. ¶4). They are marketed as ketogenic weight loss formulas containing a "Proprietary Blend" of BHB salts, including Magnesium Beta Hydroxybutyrate, Calcium Beta Hydroxybutyrate, and Sodium Beta Hydroxybutyrate (Compl. ¶55, p. 19). The complaint alleges these products are sold to aid the body in achieving nutritional ketosis for purposes of weight loss and increased energy (Compl. ¶¶ 15, 58).

IV. Analysis of Infringement Allegations

U.S. Patent No. 11,241,403 Infringement Allegations

• Identified Points of Contention:
  • Evidentiary Question: The complaint alleges the "at least 20% by weight" limitation is met but does not provide a calculation based on the public-facing label, which lists the BHB salts in a "Proprietary Blend." The court will likely require extrinsic evidence, such as product testing or discovery into the formulation, to determine if this quantitative limitation is met.
  • Scope Question: The negative limitation "free of...glycerides or other esters thereof" may be a point of dispute. A defendant could argue that common excipients, such as the listed "Magnesium Stearate," are technically esters, raising the question of whether "free of" means absolutely absent or merely not included as a primary active ingredient.

U.S. Patent No. 11,020,362 Infringement Allegations

• Identified Points of Contention:
  • Scope Question: As with the '403 Patent, the construction of the term "free of...glycerides or other esters thereof" will be critical. The presence of excipients like Magnesium Stearate in the accused formulation raises a potential non-infringement argument depending on how narrowly or broadly that exclusionary language is interpreted.

V. Key Claim Terms for Construction

• The Term: "free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof" (from Claim 1 of both patents)

  • Context and Importance: This is a negative limitation that excludes a specific class of chemical compounds. Its construction is critical because the Accused Products' labels list "Magnesium Stearate" as an "Other Ingredient" (Compl. p. 19), and stearates are a type of ester. The infringement analysis may turn on whether this excipient falls within the scope of the excluded "other esters thereof."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (i.e., excluding more): A party could argue the plain and ordinary meaning of "esters" is broad and encompasses excipients like magnesium stearate, suggesting the claim requires absolute absence. The patent repeatedly distinguishes the invention from prior art that combines BHB with ketone precursors like MCTs, supporting an intent to exclude such compounds entirely ('403 Patent, col. 9:10-24).
    • Evidence for a Narrower Interpretation (i.e., excluding less): A party could argue that, in the context of the patent, "other esters thereof" refers only to esters that function as ketone precursors, similar to medium chain fatty acids and glycerides. The specification’s focus is on avoiding other ketone-producing sources ('362 Patent, col. 6:21-34), suggesting that non-precursor esters used as excipients may not have been contemplated for exclusion.

• The Term: "at least 20% by total weight of calcium beta-hydroxybutyrate and/or magnesium beta-hydroxybutyrate" (from Claim 1 of the '403 Patent)

  • Context and Importance: This quantitative limitation defines a specific compositional requirement that distinguishes the '403 patent from other formulations. Practitioners may focus on this term because proof of infringement requires specific evidence of the product's internal composition, which is not fully disclosed on the product label's "Proprietary Blend" (Compl. ¶61, p. 22).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The use of "and/or" suggests the 20% threshold can be met by the weight of calcium BHB alone, magnesium BHB alone, or the sum of their weights. The specification repeatedly emphasizes the benefits of calcium and magnesium for bone health and mitigating soft tissue calcification, supporting the importance of their substantial presence ('403 Patent, col. 7:36-52).
    • Evidence for a Narrower Interpretation: The term requires calculation based on the "total weight" of the "beta-hydroxybutyrate salts." A party could argue this denominator is limited strictly to the salt compounds themselves, excluding any fillers or excipients, which could impact the final percentage calculation.

VI. Other Allegations

• Indirect Infringement: The complaint alleges inducement of infringement, stating that Defendant has actual knowledge of the patents and induces its customers and others to use the Accused Products in an infringing manner (Compl. ¶¶ 65, 81).
• Willful Infringement: Willfulness is alleged based on Defendant's purported actual knowledge of the patents and its infringement (Compl. ¶¶ 66, 82). The complaint further alleges that Defendant's conduct is "knowing and willful" because it uses Plaintiff's "goBHB®" trademark and expressly acknowledges on its product listings that it uses "patented formulas of BHB" (Compl. ¶¶ 23, 25).

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

• A central issue will be one of evidentiary proof: can the Plaintiff, through discovery or testing, demonstrate that the "Proprietary Blend" in the Accused Products meets the specific quantitative limitation of the '403 patent, which requires that calcium and/or magnesium BHB salts constitute at least 20% of the total BHB salt weight?
• A key question of claim scope will be the interpretation of the negative limitation "free of...glycerides or other esters thereof." The case may turn on whether this phrase is construed to exclude common manufacturing excipients like magnesium stearate, or if its scope is limited to compounds that function as active ketone precursors.