DCT

1:25-cv-00170

Axcess Global Sciences LLC v. Vitanav Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00170, D. Del., 02/12/2025
  • Venue Allegations: Venue is asserted in the District of Delaware based on Defendant's incorporation in Delaware, its maintenance of a registered agent in the state, and allegations that a substantial portion of the infringing acts giving rise to the action occurred from Delaware.
  • Core Dispute: Plaintiff alleges that Defendant’s ketone supplement drinks infringe five patents related to specific chemical compositions of beta-hydroxybutyrate (BHB) designed to induce or sustain nutritional ketosis in humans.
  • Technical Context: The technology relates to exogenous ketone supplements, a product category in the health and wellness market aimed at providing the metabolic benefits of a ketogenic diet without strict dietary adherence.
  • Key Procedural History: The complaint alleges that Defendant received actual notice of infringement for U.S. Patent Nos. 11,020,362 and 11,241,403 on July 25, 2024, and for U.S. Patent Nos. 12,128,020, 12,109,182, and 12,090,129 on December 25, 2024. These pre-suit notice dates form the basis for allegations of willful infringement.

Case Timeline

Date Event
2016-03-11 Earliest Patent Priority Date for Asserted Patents
2021-06-01 U.S. Patent No. 11,020,362 Issues
2022-02-08 U.S. Patent No. 11,241,403 Issues
2022-11-28 Date of Potassium and Sodium Testing (Certificate of Analysis)
2022-11-30 Date of Chiral Testing for 1,3 Butanediol (Certificate of Analysis)
2022-12-13 Date of BHB and Salts Testing (Certificate of Analysis)
2022-12-22 Date of Chiral Testing of BHB (Certificate of Analysis)
2024-07-25 Alleged Actual Notice of Infringement (’362 and ’403 Patents)
2024-09-17 U.S. Patent No. 12,090,129 Issues
2024-10-08 U.S. Patent No. 12,109,182 Issues
2024-10-29 U.S. Patent No. 12,128,020 Issues
2024-12-25 Alleged Actual Notice of Infringement (’020, ’182, and ’129 Patents)
2025-02-12 Complaint Filed

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

U.S. Patent No. 12,128,020 - “Administration of R-beta-hydroxybutyrate and related compounds in humans”

The Invention Explained

  • Problem Addressed: The patent background sections of related patents describe the difficulty for individuals in transitioning into and sustaining a state of nutritional ketosis through diet alone, a process often accompanied by undesirable physiological effects like electrolyte imbalances (e.g., ’362 Patent, col. 3:32-51).
  • The Patented Solution: The invention provides an exogenous ketone composition that can be orally ingested to increase blood ketone levels (Compl. ¶20). The ’020 Patent specifically claims a composition combining a liquid carrier (like water), D-beta-hydroxybutyrate (BHB), and R-1,3-butanediol, a precursor to D-BHB acid, to provide a source of ketones for the body to use as fuel (Compl. ¶¶6, 20; ’362 Patent, col. 4:56-62).
  • Technical Importance: This approach aims to provide the metabolic benefits of ketosis, such as utilizing fat for energy, without the strict dietary restrictions or negative side effects typically required to achieve it endogenously (e.g., ’362 Patent, col. 4:1-12).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶21).
  • Claim 1 of the ’020 Patent recites a beta-hydroxybutyrate composition with the following essential elements:
    • Formulated for oral delivery to increase blood ketone level.
    • A liquid carrier comprising at least one of water, milk, drinkable liquid, etc.
    • D-beta-hydroxybutyrate, which in turn comprises D-beta-hydroxybutyric acid and optionally one or more D-beta-hydroxybutyrate salts or esters.
    • R-1,3-butanediol.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 12,109,182 - “Administration of r-beta-hydroxybutyrate and related compounds in humans”

The Invention Explained

  • Problem Addressed: As with related patents, the invention addresses the challenge of achieving and maintaining ketosis (e.g., ’403 Patent, col. 1:45-2:20). A specific technical challenge in formulating BHB supplements is managing stereoisomers (enantiomers), as the body primarily produces and utilizes the R-enantiomer (also called D-BHB), while synthetic production often yields a racemic mixture of both R- and S-enantiomers (’129 Patent, Abstract).
  • The Patented Solution: The ’182 Patent claims a composition comprising a specific "non-racemic mixture" of R-beta-hydroxybutyrate and S-beta-hydroxybutyrate (Compl. ¶32). The claims require the mixture to be enriched with the biologically active R-enantiomer (approximately 90% to less than 100%) but also to contain a small amount of the S-enantiomer (greater than 0% to approximately 10%), suggesting a potential role or benefit for the S-enantiomer when present in this ratio (’129 Patent, col. 3:1-11).
  • Technical Importance: This approach seeks to optimize exogenous ketone supplementation by providing a composition that is biochemically similar to what the body produces endogenously, potentially enhancing efficacy while exploring the effects of specific, non-racemic enantiomeric ratios.

Key Claims at a Glance

  • The complaint asserts independent claim 1 (Compl. ¶33).
  • Claim 1 of the ’182 Patent recites a composition with the following essential elements:
    • A non-racemic mixture of R-beta-hydroxybutyrate and S-beta-hydroxybutyrate.
    • The mixture contains from approximately 90% to less than 100% of R-beta-hydroxybutyrate.
    • The mixture contains from greater than 0% to approximately 10% of S-beta-hydroxybutyrate.
    • The composition is provided in a form such as a pill, powder, or beverage.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 12,090,129 - “Non-racemic beta-hydroxybutyrate compounds and compositions enriched with the R-enantiomer and methods of use”

  • Technology Synopsis: This patent claims a non-racemic BHB mixture with different percentage ranges than the ’182 Patent (more than 50% but less than 100% R-BHB; less than 50% but more than 0% S-BHB) (Compl. ¶45). The claim further requires that this mixture specifically include at least one R-BHB salt, at least one S-BHB salt, and at least one R- or S-BHB acid, defining a specific chemical makeup beyond just the enantiomeric ratio (Compl. ¶45).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶46).
  • Accused Features: The complaint alleges that the Accused Products contain ingredients (D-BHB acid, sodium carbonate, potassium carbonate, magnesium carbonate) that react to form the claimed mixture of R-BHB salt, S-BHB salt, and BHB acid in situ (Compl. ¶¶47, 49).

U.S. Patent No. 11,020,362 - “Beta-hydroxybutyrate mixed salt compositions and methods of use”

  • Technology Synopsis: This patent addresses the problem of electrolyte imbalance when supplementing with BHB salts by claiming a specific combination of salts (’362 Patent, col. 7:7-21). The invention is a composition for increasing ketone levels that comprises at least three BHB salts selected from a group including sodium, potassium, calcium, and magnesium BHB, and is explicitly "free of medium chain fatty acids" (Compl. ¶60).
  • Asserted Claims: Representative claim 12 is asserted (Compl. ¶60).
  • Accused Features: The complaint alleges that the Accused Products contain ingredients that form sodium BHB, potassium BHB, and magnesium BHB, and that the products are free of medium chain fatty acids, thereby meeting the claim limitations (Compl. ¶¶63-65, 66).

U.S. Patent No. 11,241,403 - “Beta-hydroxybutyrate mixed salt compositions and methods of use”

  • Technology Synopsis: This patent also addresses electrolyte balance but claims a composition with specific weight ratios between different BHB salts (’403 Patent, col. 1:53-2:6). Asserted claim 16 requires a plurality of BHB salts where calcium and magnesium salts make up 15-50% of the total weight of BHB salts, and the total weight of sodium and potassium salts is greater than the total weight of calcium and magnesium salts (Compl. ¶80). Like the ’362 Patent, it also requires the composition to be free of medium chain fatty acids.
  • Asserted Claims: Representative claim 16 is asserted (Compl. ¶80).
  • Accused Features: The complaint alleges the Accused Products form a mixture of sodium, potassium, and magnesium BHB salts that meets the specific weight ratio limitations and is free of medium chain fatty acids (Compl. ¶¶84-87).

III. The Accused Instrumentality

Product Identification

  • The Kenetik: Ketone Concentrate and Kenetik: Ketone Drink products (collectively, the "Accused Products") (Compl. ¶7).

Functionality and Market Context

  • The Accused Products are described as "exogenous ketone" dietary supplements formulated to provide a "boost of mental energy and sharper focus" by delivering ketones to the body (Compl. ¶¶8, 9, 11). The complaint presents screenshots of the product's ingredient list, which explicitly names "Biocycle™ (D)-ß-hydroxybutyric acid" and "Avela™ (R)-1,3 butanediol" as key components (Compl. p. 4). The ingredient list also includes water, sodium bicarbonate, potassium bicarbonate, and magnesium carbonate (Compl. p. 11).
  • The complaint alleges Defendant sells the Accused Products through its own website and third-party retailers such as Amazon.com and Walmart, positioning them in the competitive health and wellness market for BHB supplements (Compl. ¶¶7, 13). Plaintiff alleges that it directly competes with Defendant in this market (Compl. ¶15).

IV. Analysis of Infringement Allegations

12,128,020 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A beta-hydroxybutyrate composition formulated for ingestion by oral delivery as a beverage... to increase blood ketone level in a subject The Accused Products are sold as ketone energy drinks and concentrates intended for oral ingestion to boost ketones (Compl. ¶9). ¶¶7, 9, 19 Specification not provided in source documents.
a liquid carrier comprising at least one of water... The first ingredient listed for the Accused Products is "water" or "Carbonated Filtered Water" (Compl. p. 11). ¶¶22, 23 Specification not provided in source documents.
D-beta-hydroxybutyrate, wherein the D-beta-hydroxybutyrate comprises D-beta-hydroxybutyric acid and optionally one or more D-beta-hydroxybutyrate salts or esters The ingredient list identifies "Biocycle™ D-ß-Hydroxybutyric (BHB) Acid" (Compl. p. 11). The complaint also points to a Certificate of Analysis showing the presence of "D-BHB" (Compl. p. 10). The presence of salts is inferred from other ingredients like sodium and potassium bicarbonate. ¶¶22, 23 Specification not provided in source documents.
R-1,3-butanediol The ingredient list identifies "Avela™ R-1,3 Butanediol" (Compl. p. 11). The Certificate of Analysis also reports the presence of "R-1,3-BUTANEDIOL" (Compl. p. 12). This Certificate of Analysis, attached as Exhibit F, provides third-party testing results for the Kenetik drink product (Compl. ¶10, p. 6). ¶¶22, 23 Specification not provided in source documents.
  • Identified Points of Contention:
    • Scope Questions: A potential point of dispute may be whether the combination of D-beta-hydroxybutyric acid and various bicarbonate salts (sodium, potassium, magnesium) in the final product constitutes "D-beta-hydroxybutyrate" which "comprises... optionally one or more D-beta-hydroxybutyrate salts" as required by the claim. The defense may argue that the claim requires pre-formed BHB salts, whereas the complaint suggests the salts are formed in situ when the acid reacts with the bicarbonates.
    • Technical Questions: The complaint relies on Defendant's ingredient list and a plaintiff-commissioned Certificate of Analysis to show the presence of the claimed components. The evidentiary weight and accuracy of this analysis, particularly regarding the specific stereoisomer "R-1,3-butanediol," will be a central factual question.

12,109,182 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A composition for administering ketone bodies to a subject, comprising: a non-racemic mixture of R-beta-hydroxybutyrate and S-beta-hydroxybutyrate The Accused Products are alleged to be compositions containing a mixture of D-BHB (the R-enantiomer) and L-BHB (the S-enantiomer) based on a Certificate of Analysis (Compl. p. 17). ¶¶31, 34 Specification not provided in source documents.
wherein the non-racemic mixture contains from approximately 90% to less than 100% of R-beta-hydroxybutyrate The Certificate of Analysis reports 7430.21 mg/serving of D-BHB (R-BHB) and 844.24 mg/serving of L-BHB (S-BHB). This calculates to approximately 89.8% D-BHB (R-BHB) of the total BHB content, which the complaint alleges meets the "approximately 90%" limitation. ¶¶34, 35, 36 Specification not provided in source documents.
and from greater than 0% to approximately 10% of S-beta-hydroxybutyrate The same Certificate of Analysis calculates to approximately 10.2% L-BHB (S-BHB), which the complaint alleges meets the "approximately 10%" limitation (Compl. p. 19). ¶¶34, 35, 36 Specification not provided in source documents.
wherein the composition is provided as or in a... drinkable liquid, or beverage. The Accused Products are sold as a "Ketone Drink" and "Ketone Concentrate," which are beverages or drinkable liquids (Compl. p. 3). ¶¶31, 36 Specification not provided in source documents.
  • Identified Points of Contention:
    • Scope Questions: The central dispute will likely focus on the word "approximately." The complaint's own evidence shows a calculated value of 89.8% R-BHB and 10.2% S-BHB. The question for the court will be whether 89.8% satisfies the "approximately 90%" lower bound and whether 10.2% satisfies the "approximately 10%" upper bound, or if these figures fall outside the claimed ranges.
    • Technical Questions: The entire infringement theory rests on the accuracy of the Certificate of Analysis commissioned by the Plaintiff. Defendant will likely challenge the testing methodology, chain of custody, and statistical significance of the reported values to argue that its products do not, in fact, contain the claimed enantiomeric ratio.

V. Key Claim Terms for Construction

  • The Term: "approximately 90% to less than 100% of R-beta-hydroxybutyrate" (from claim 1 of the ’182 Patent)

  • Context and Importance: This term's construction is dispositive for infringement of the ’182 Patent. The Plaintiff's own evidence indicates a value of 89.8% R-BHB. Therefore, the case may turn entirely on whether "approximately 90%" is construed to encompass values just below 90.0%. Practitioners may focus on this term because it is a classic claim construction battleground where a numerical limitation is modified by a term of approximation.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification of a related patent (’129 Patent) discusses various enantiomeric percentages but does not define or limit the term "approximately," which may suggest to a fact-finder that it should be given its plain and ordinary meaning, allowing for minor variations consistent with scientific measurement tolerances.
    • Evidence for a Narrower Interpretation: The claim recites a specific numerical range. A defendant may argue that if the patentee intended to claim values below 90%, they could have written "from 89% to..." or a similar range. The use of a precise number like "90" may suggest that "approximately" is meant to cover only minor rounding or measurement noise, not a deviation of several tenths of a percent.

  • The Term: "D-beta-hydroxybutyrate... comprises D-beta-hydroxybutyric acid and optionally one or more D-beta-hydroxybutyrate salts or esters" (from claim 1 of the ’020 Patent)

  • Context and Importance: This term is critical because the Accused Product's ingredient list discloses D-BHB acid and various bicarbonate salts, but not pre-formed D-BHB salts. The infringement theory depends on construing this claim to cover a composition where the claimed BHB salts are formed in situ.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The claim uses the open-ended term "comprising," which is generally interpreted to mean "including but not limited to." A plaintiff could argue that as long as the final composition ingested by the user contains both the acid and the salts (regardless of how they were formed), the limitation is met. The specification of the related ’362 patent broadly discusses formulating BHB compositions without limiting the method of salt formation (e.g., ’362 Patent, col. 4:13-30).
    • Evidence for a Narrower Interpretation: A defendant may argue that the claim language requires starting with, or providing, D-BHB salts as an ingredient. The structure of the claim lists "D-beta-hydroxybutyrate" as a component, and then defines what that component "comprises." This could be interpreted to mean that the "D-beta-hydroxybutyrate" component itself must contain the acid and optional salts, rather than being formed later from separate ingredients.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement for the ’362 and ’403 patents, stating Defendant induces its customers to infringe (Compl. ¶¶68, 89). The complaint does not specify the acts of inducement, such as instructions or advertisements, but this could be developed during discovery.
  • Willful Infringement: Willfulness is alleged for all five patents. The claims are based on Defendant's alleged knowledge of the patents after receiving actual notice from the Plaintiff on two separate dates (July 25, 2024, and December 25, 2024) and continuing its alleged infringement thereafter (Compl. ¶¶26, 39, 53, 69, 90).

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

  • A core issue will be one of evidentiary proof: Will the plaintiff's third-party Certificate of Analysis be deemed sufficiently reliable and accurate to prove that the Accused Products contain the specific enantiomeric ratios and chemical components required by the asserted claims, particularly for the ’182 and ’129 patents?
  • A key legal question will be one of definitional scope: Can the term "approximately 90%" in the ’182 Patent be construed to cover the 89.8% value derived from the plaintiff's own evidence, and can the claim language in the ’020 patent regarding a component that "comprises" both an acid and salts be read to cover a product where those salts are allegedly formed in situ from separate ingredients?
  • A central question for damages will be one of intent: Did the Defendant's alleged continued sales after receiving actual notice of infringement on two separate dates rise to the level of willful misconduct, potentially exposing it to enhanced damages?