DCT

1:25-cv-00708

Axcess Global Sciences LLC v. Triplepulse Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00708, D. Del., 06/06/2025
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant is a Delaware corporation with a registered agent in the state, and a substantial portion of the alleged infringements occurred from Delaware.
  • Core Dispute: Plaintiff alleges that Defendant’s "TruBrain Ketones" supplement infringes six patents related to specific chemical formulations of beta-hydroxybutyrate (BHB) salts designed to induce and sustain ketosis.
  • Technical Context: The technology lies in the nutritional supplement field, specifically concerning exogenous ketone bodies that allow users to achieve a metabolic state of ketosis without strictly adhering to a ketogenic diet.
  • Key Procedural History: The complaint alleges that Plaintiff provided Defendant with actual notice of infringement for all six asserted patents prior to filing this lawsuit. It also notes that Plaintiff has engaged in prior enforcement actions against other retailers to protect its rights in the asserted patents.

Case Timeline

Date Event
2016-03-11 Earliest Priority Date for ’952, ’861, ’362, ’403 Patents
2017-11-22 Earliest Priority Date for ’876, ’131 Patents
2019-05-21 U.S. Patent No. 10,292,952 Issues
2020-03-17 U.S. Patent No. 10,588,876 Issues
2020-03-24 U.S. Patent No. 10,596,131 Issues
2020-08-11 U.S. Patent No. 10,736,861 Issues
2021-06-01 U.S. Patent No. 11,020,362 Issues
2022-02-08 U.S. Patent No. 11,241,403 Issues
2023-01-05 Accused Product Testing Date (Certificate of Analysis)
2023-01-10 Accused Product Testing Date (Certificate of Analysis)
2023-01-17 Accused Product Testing Date (Certificate of Analysis)
2023-01-19 Accused Product Testing Date (Certificate of Analysis)
2024-08-13 Accused Product Received for Testing (Analytical Report)
2024-08-15 Accused Product Testing Date (Analytical Report)
2024-08-27 Accused Product Testing Date (Analytical Report)
2024-09-10 Accused Product Testing Date (Analytical Report)
2025-06-06 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

The Invention Explained

  • Problem Addressed: The patent’s background section describes the difficulty of transitioning into and maintaining a ketogenic state, noting that the process often disrupts normal electrolyte balances, leading to adverse effects commonly known as the "low-carb flu" (e.g., fatigue, muscle cramping, headaches) (’952 Patent, col. 2:36-55).
  • The Patented Solution: The invention is a beta-hydroxybutyrate (BHB) composition formulated as a mixed salt with a "biologically balanced set of cationic electrolytes," such as sodium, potassium, calcium, and magnesium. This composition is designed to induce or sustain ketosis without causing or aggravating the electrolyte imbalances associated with either the metabolic state itself or with consuming high doses of a single-cation BHB salt (’952 Patent, Abstract; col. 3:1-9).
  • Technical Importance: This approach sought to improve the safety and tolerability of exogenous ketone supplements, potentially making ketogenic lifestyles more accessible to a broader population by mitigating common negative side effects.

Key Claims at a Glance

  • The complaint asserts independent claim 19 (Compl. ¶22).
  • 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 (BHB) mixed salt formulated from a plurality of different cations and a single anion, which is BHB itself, with other anions being omitted.
    • The cations are formulated to provide a "biologically balanced set of cationic electrolytes."
    • The mixed salt comprises at least three salts selected from the group of sodium BHB, potassium BHB, calcium BHB, and magnesium BHB, with each selected salt present in an amount of 10-70% by weight.
    • The mixed salt is in solid and/or powder form.
  • The complaint does not explicitly reserve the right to assert dependent claims for the ’952 Patent.

U.S. Patent No. 10,588,876 - "Non-racemic beta-hydroxybutyrate compounds and compositions enriched with the R-enantiomer and methods of use," issued March 17, 2020

The Invention Explained

  • Problem Addressed: The patent notes that while the R-enantiomer of BHB is the form endogenously produced by the human body, commercial supplements often use a racemic (50/50) mixture of R- and S-enantiomers. The patent background acknowledges the view that the non-endogenous S-enantiomer is potentially "ineffective or even harmful" (’876 Patent, col. 2:63-67).
  • The Patented Solution: The invention claims a method using a non-racemic mixture of R-BHB and S-BHB that is enriched with the R-enantiomer but which purposefully retains a significant amount of the S-enantiomer. The specification suggests that contrary to being merely inert, the S-enantiomer may provide alternative benefits such as prolonged ketosis or endogenous conversion into fatty acids and sterols (’876 Patent, Abstract; col. 5:1-12).
  • Technical Importance: This technology challenges the prevailing views of using either purely racemic or purely R-enantiomer BHB by proposing that specific, unbalanced enantiomeric ratios can achieve unique or superior therapeutic effects.

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶38).
  • Essential elements of claim 1 include:
    • A method for increasing ketone body level in a subject.
    • The method comprises administering a composition that includes a non-racemic mixture of R-BHB and S-BHB, enriched with the R-BHB enantiomer relative to the S-BHB enantiomer.
    • The mixture contains up to 89% R-BHB and at least 11% S-BHB by enantiomeric equivalents.
    • A proviso states that the mixture contains no more than 88% by enantiomeric equivalents of a specific mono-ester of R-1,3-butanediol and R-BHB.
  • The complaint does not explicitly reserve the right to assert dependent claims for the ’876 Patent.

Multi-Patent Capsule: U.S. Patent No. 10,596,131

  • Patent Identification: U.S. Patent No. 10,596,131, "Non-racemic beta-hydroxybutyrate compounds and compositions enriched with the R-enantiomer and methods of use," issued March 24, 2020.
  • Technology Synopsis: This patent, related to the ’876 Patent, concerns compositions containing specific non-racemic mixtures of R- and S-enantiomers of BHB. The invention claims a composition, rather than a method, with specific percentage ranges of each enantiomer (more than 50% and up to 89% R-BHB; less than 50% and at least 11% S-BHB) intended to provide therapeutic benefits (’131 Patent, Abstract; col. 16:1-17).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶57).
  • Accused Features: The specific ratio of D-BHB (R-BHB) to L-BHB (S-BHB) in the Accused Product, as allegedly determined by Plaintiff's independent testing (Compl. ¶¶ 61-62; Exh. H).

Multi-Patent Capsule: U.S. Patent No. 10,736,861

  • Patent Identification: U.S. Patent No. 10,736,861, "Mixed Salt Compositions for Producing Elevated and Sustained Ketosis," issued August 11, 2020.
  • Technology Synopsis: This patent, related to the ’952 Patent, claims a kit for administering exogenous ketones. The invention addresses the need for proper dosing by claiming a kit that includes a container holding a BHB mixed salt composition (comprising sodium, potassium, calcium, and magnesium BHB) and a measuring device configured to hold a unit dose of the composition (’861 Patent, Abstract; col. 16:1-25).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶76).
  • Accused Features: The Accused Product is sold as a powder in a tub (the container) and includes a scoop (the measuring device) for dosing the BHB salt composition (Compl. ¶¶ 80-81). An image in the complaint depicts a person using a scoop with the product container (Compl., p. 27).

Multi-Patent Capsule: U.S. Patent No. 11,020,362

  • Patent Identification: U.S. Patent No. 11,020,362, "Beta-hydroxybutyrate mixed salt compositions and methods of use," issued June 1, 2021.
  • Technology Synopsis: This patent claims a specific BHB formulation defined by what it excludes. The invention is a composition comprising at least three BHB salts from the group of sodium, potassium, calcium, and magnesium, but which is explicitly "free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof" (’362 Patent, Abstract).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶93).
  • Accused Features: The chemical composition of the Accused Product, which allegedly contains the required BHB salts while being free of the excluded medium chain fatty acids and esters (Compl. ¶¶ 97-98).

Multi-Patent Capsule: U.S. Patent No. 11,241,403

  • Patent Identification: U.S. Patent No. 11,241,403, "Beta-hydroxybutyrate mixed salt compositions and methods of use," issued February 8, 2022.
  • Technology Synopsis: This patent claims a BHB formulation defined by minimum concentrations of specific divalent cations. The invention is a composition of multiple BHB salts wherein "at least 20% by total weight" consists of calcium BHB and/or magnesium BHB, and which is also free of medium chain fatty acids (’403 Patent, Abstract).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶110).
  • Accused Features: The quantitative composition of the Accused Product, which testing allegedly shows contains the required BHB salts with over 20% of the weight coming from calcium and magnesium BHB, while being free of the excluded fatty acids (Compl. ¶¶ 114-115; Exh. I).

III. The Accused Instrumentality

Product Identification

The accused product is "TruBrain Ketones," a nutritional supplement powder sold by Defendant (Compl. ¶8).

Functionality and Market Context

The product is marketed as containing a "BHB & Ester Blend" to "Increase Your Body's Ketone Levels" (Compl., p. 7; Exh. G). Plaintiff alleges that its independent laboratory testing revealed the product's precise chemical makeup, which includes specific quantities of sodium, potassium, calcium, and magnesium beta-hydroxybutyrate salts, as well as a non-racemic mixture of D-BHB and L-BHB enantiomers (Compl. ¶¶ 10-12; Exh. H, I). The complaint provides a Certificate of Analysis showing the specific chiral and mineral composition of the product (Compl., p. 3; Exh. H). Plaintiff also alleges that the product's ingredients label is inaccurate because it fails to disclose the presence of calcium, which was identified during testing (Compl. ¶12).

IV. Analysis of Infringement Allegations

10,292,952 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 other anions are omitted... The Accused Product contains BHB as the anion combined with four different cations: sodium, potassium, calcium, and magnesium. ¶27; Exh. I col. 5:38-44
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 Accused Product contains sodium, potassium, calcium, and magnesium BHB salts, which Plaintiff alleges meet the claimed weight percentage ranges based on lab testing. ¶27; Exh. I col. 16:12-18
wherein the beta-hydroxybutyrate mixed salt is in solid and/or powder form. The Accused Product is sold and advertised as a powder supplement. ¶27; Exh. G col. 16:19-20
  • Identified Points of Contention:
    • Technical Questions: A primary technical question is whether the Accused Product actually meets the "10-70% by weight" limitation for at least three salts. The complaint's supporting Analytical Report shows values for sodium, potassium, calcium, and magnesium BHB salts (Compl., p. 9; Exh. I). A calculation based on the total weight of these four salts (14,730 mg) suggests the potassium salt comprises approximately 7.8% of the mix, which falls outside the claimed 10-70% range. This raises the question of what constitutes the "beta-hydroxybutyrate mixed salt" for the purpose of the weight percentage calculation and whether the complaint's allegation is factually supported by its own evidence.
    • Scope Questions: What is the scope of a "biologically balanced set of cationic electrolytes"? The complaint makes a conclusory allegation that the product meets this limitation, but the term itself may be indefinite or require construction based on disclosures in the patent, such as specific molar ratios between certain cations.

10,588,876 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
...a non-racemic mixture of R-beta-hydroxybutyrate and S-beta-hydroxybutyrate that is enriched with the R-beta-hydroxybutyrate relative to the S-beta-hydroxybutyrate... Plaintiff's lab testing allegedly shows the Accused Product contains approximately 51.83% D-BHB (R-enantiomer) and 48.17% L-BHB (S-enantiomer), which is a non-racemic mixture with more R-BHB than S-BHB. ¶43; Exh. H col. 3:1-12
...the non-racemic mixture contains up to 89% by enantiomeric equivalents of the R-beta-hydroxybutyrate and at least 11% by enantiomeric equivalents of the S-beta-hydroxybutyrate... The alleged test results of 51.83% R-BHB and 48.17% S-BHB fall within the claimed percentage ranges. ¶44; Exh. H col. 14:1-5
...with the proviso that the non-racemic mixture contains no more than 88% by enantiomeric equivalents of mono-ester of R-1,3-butanediol and R-beta-hydroxybutyrate. Lab testing allegedly confirms the presence of only a trace amount of 1,3-butanediol (11.5mg per 16.5g serving), suggesting this limitation is met. ¶45; Exh. H col. 14:5-8
  • Identified Points of Contention:
    • Scope Questions: A key question for claim construction is the meaning of "enriched with the R-beta-hydroxybutyrate." Plaintiff's infringement theory relies on the lab result showing a slight majority of the R-enantiomer (~52%). The court will need to determine if "enriched" simply means any amount greater than 50%, or if it requires a more substantial or statistically significant deviation from a racemic mixture, particularly in light of the patent's goal of providing a "greater and/or faster ketogenic effect" (’876 Patent, col. 3:16-20).

V. Key Claim Terms for Construction

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

    • Context and Importance: This qualitative term is central to the purported novelty of the ’952 Patent, which aims to solve the problem of electrolyte imbalance. The infringement analysis depends on whether the accused formulation, which contains four common electrolytes, meets this standard. Practitioners may focus on this term because its potential ambiguity could be a basis for a non-infringement or invalidity defense.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification describes the goal as avoiding "detrimental health effects" and "negative electrolyte imbalances" generally, which could support a broad definition covering any mixture that is not overtly harmful (’952 Patent, col. 5:14-19, 35-37).
      • Evidence for a Narrower Interpretation: The specification discloses that in preferred embodiments, "the molar ratio of sodium ions to potassium ions is no greater than 1, and/or...the molar ratio of calcium ions to magnesium ions in no greater than 1" (’952 Patent, col. 8:54-61). This language may support a narrower construction that requires the composition to meet these specific ionic ratios to be considered "biologically balanced."

  • The Term: "enriched with the R-beta-hydroxybutyrate relative to the S-beta-hydroxybutyrate" (’876 Patent, Claim 1)

    • Context and Importance: The infringement reading for the ’876 Patent hinges on the lab result of ~52% R-BHB vs. ~48% S-BHB. The viability of the claim depends on whether this slight majority constitutes "enrichment" as used in the patent.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The plain meaning of "enriched" suggests any amount greater than the other component. The patent's objective is to provide a "non-racemic" mixture, distinguishing it from 50/50 racemic compositions, which supports interpreting any deviation from 50/50 in favor of the R-enantiomer as "enrichment" (’876 Patent, col. 3:1-5).
      • Evidence for a Narrower Interpretation: The specification states the purpose of the enrichment is to provide a "greater and/or faster ketogenic effect compared to a racemic mixture" (’876 Patent, col. 3:16-20). This may support a narrower, functional definition where "enriched" requires a ratio proven to produce a meaningfully faster or greater effect than a 50/50 mixture, a standard a ~52/48 split might not meet.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendant induces infringement for all asserted patents by "actively inducing others—including its own customers—to directly infringe" (e.g., Compl. ¶29, ¶47, ¶65). The complaint does not, however, allege specific facts such as identifying instructions on product labels or user manuals that direct customers to use the product in an infringing manner.
  • Willful Infringement: The complaint alleges willful infringement for all six patents. The basis for this allegation is that Plaintiff provided Defendant with "actual notice of their infringement...prior to the filing of this lawsuit" (e.g., Compl. ¶21, ¶37, ¶55). This alleges pre-suit knowledge of the patents and the alleged infringement.

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

  • A core issue will be one of quantitative compliance: do the specific concentrations of BHB salts in the Accused Product, as detailed in the complaint’s own exhibits, factually satisfy the numeric percentage limitations recited in multiple asserted claims? For instance, analysis of the complaint's evidence raises the question of whether the potassium BHB concentration meets the "10-70% by weight" requirement of the ’952 Patent.
  • A central dispute will likely be one of definitional scope: can the term "enriched," as used in the ’876 and ’131 Patents, be construed to cover a non-racemic mixture with only a slight majority (~52%) of the R-enantiomer, or does the patent’s context require a more substantial deviation from a 50/50 racemic mixture to achieve the stated goal of a faster or greater ketogenic effect?
  • A key evidentiary question for the willfulness allegations will be the substance of the pre-suit notice: what specific information was conveyed to the Defendant prior to the lawsuit, and was it sufficiently detailed to establish the knowledge and intent required to support a claim for willful infringement under the Halo standard?