DCT

1:26-cv-00047

Axcess Global Sciences LLC v. Naturelo Premium Supplements LLC

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:26-cv-00047, D. Del., 01/15/2026
  • Venue Allegations: Venue is based on Defendant's incorporation and registered agent in Delaware, and the allegation that a substantial portion of the infringing acts occurred in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s apple cider vinegar dietary supplement infringes a patent related to specific mixed-salt compositions of beta-hydroxybutyrate (BHB).
  • Technical Context: The technology relates to exogenous ketone supplements, which are designed to help the human body enter or sustain a state of nutritional ketosis for metabolic health and wellness benefits.
  • Key Procedural History: The complaint alleges that Plaintiff provided Defendant with actual notice of infringement prior to filing the lawsuit. It also mentions Plaintiff has engaged in prior enforcement actions against other retailers to protect its rights in the asserted patent.

Case Timeline

Date Event
2016-03-11 U.S. Patent No. 11,241,403 Priority Date
2022-02-08 U.S. Patent No. 11,241,403 Issued
2024-12-16 Accused Product Sample Received for Analysis
2025-01-03 Analytical Report on Accused Product Issued
2026-01-15 Complaint Filed

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

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

  • Patent Identification: U.S. Patent No. 11,241,403, Beta-hydroxybutyrate mixed salt compositions and methods of use, issued February 8, 2022 (’403 Patent).

The Invention Explained

  • Problem Addressed: The patent describes the difficulty for individuals to enter and maintain a state of nutritional ketosis through diet alone, citing detrimental side effects like the "low-carb flu" and, critically, electrolyte imbalances caused by metabolic shifts and increased urination that depletes the body of essential minerals. (’403 Patent, col. 2:21-54).
  • The Patented Solution: The invention is a composition of multiple beta-hydroxybutyrate (BHB) salts designed to induce ketosis while also providing a "biologically balanced set of cation electrolytes." (’403 Patent, col. 7:61-64). By combining specific BHB salts (e.g., sodium, potassium, calcium, magnesium), the composition aims to deliver ketones for energy without causing or aggravating the electrolyte imbalances associated with ketosis. (’403 Patent, Abstract).
  • Technical Importance: This approach seeks to make the benefits of ketosis more accessible and sustainable by mitigating common negative side effects, thereby improving user compliance and outcomes. (’403 Patent, col. 7:1-4).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and reserves the right to assert additional claims. (Compl. ¶19).
  • Essential elements of independent claim 1 include:
    • A composition for increasing ketone level in a subject.
    • Comprising a plurality of beta-hydroxybutyrate (BHB) salts.
    • This plurality includes at least one BHB salt from the group of calcium BHB and magnesium BHB.
    • This plurality also includes at least one other BHB salt from a second group including sodium BHB, potassium BHB, calcium BHB, magnesium BHB, and amino acid salts of BHB.
    • The total BHB salts in the composition must comprise at least 20% by total weight of calcium and magnesium BHB salts.
    • The composition must be in a solid and/or powder form.
    • The composition must be free of medium chain fatty acids (MCFAs) with 6 to 12 carbons, as well as their glycerides or other esters.

III. The Accused Instrumentality

Product Identification

  • The accused products are various dietary supplements sold by Defendant, with the "Naturelo Apple Cider Vinegar" capsules identified as an exemplary product. (Compl. ¶7).

Functionality and Market Context

  • The accused product is a dietary supplement in capsule form. (Compl. p. 2). Its marketing materials claim it provides a "KETO BOOST COMBO" using "keto salts (Sodium and Calcium BHB) to increase Beta-Hydroxybutyrate ketone levels." (Compl. p. 8). The supplement facts label lists "Calcium Beta-Hydroxybutyrate" and "Sodium Beta-Hydroxybutyrate" as ingredients. (Compl. p. 3). The complaint alleges the accused products are sold through Defendant's website and third-party retailers like Amazon and Walmart. (Compl. ¶12). A "Supplement Facts" label for the accused product is reproduced in the complaint. (Compl. p. 3, Fig. on p. 3).

IV. Analysis of Infringement Allegations

Claim Chart Summary

  • The complaint provides a narrative infringement analysis supported by the accused product's label and a third-party Certificate of Analysis. The Certificate of Analysis provides a quantitative breakdown of the ingredients in the accused product. (Compl. p. 4, Fig. on p. 4).

’403 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a plurality of beta-hydroxybutyrate salts comprised of: The accused product contains both Calcium Beta-Hydroxybutyrate and Sodium Beta-Hydroxybutyrate. ¶23; Fig. on p. 9 col. 3:14-24
at least one beta-hydroxybutyrate salt selected from: calcium beta-hydroxybutyrate; and magnesium beta-hydroxybutyrate; and The accused product contains Calcium Beta-Hydroxybutyrate. ¶23; Fig. on p. 10 col. 15:47-49
at least one other beta-hydroxybutyrate salt selected from: sodium beta-hydroxybutyrate... The accused product contains Sodium Beta-Hydroxybutyrate. ¶23; Fig. on p. 10 col. 15:50-55
wherein the beta-hydroxybutyrate salts comprise at least 20% by total weight of calcium and magnesium beta-hydroxybutyrate salts, Based on the Certificate of Analysis, the calcium BHB salt (156 mg/svg) and magnesium BHB salt ("None Detected") comprise approximately 49% of the total measured BHB salts (316 mg/svg). ¶24; Fig. on p. 12 col. 15:56-59
wherein the composition is in solid and/or powder form, The accused product is a solid powder contained within vegetarian capsules. ¶25; Fig. on p. 13 col. 4:15-19
wherein the composition is free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof. The "Other Ingredients" list on the product label does not include any medium chain fatty acids or related compounds. ¶26; Fig. on p. 15 col. 9:8-12

Identified Points of Contention

  • Scope Questions: A primary dispute may arise from the claim language "at least one beta-hydroxybutyrate salt selected from: calcium beta-hydroxybutyrate; and magnesium beta-hydroxybutyrate." The Certificate of Analysis for the accused product reports "None Detected" for magnesium 3-hydroxybutyrate salt. (Compl. p. 4). This raises the question of whether the claim requires the presence of both calcium and magnesium BHB salts (a conjunctive reading of "and"), or if the presence of only one from that list (calcium BHB) is sufficient (a disjunctive reading of "selected from").
  • Technical Questions: What is the evidentiary weight of the "None Detected" finding in the Certificate of Analysis? The analysis will likely focus on whether this definitively proves the absence of magnesium BHB or if trace, but still effective, amounts could be present.

V. Key Claim Terms for Construction

  • The Term: "at least one beta-hydroxybutyrate salt selected from: calcium beta-hydroxybutyrate; and magnesium beta-hydroxybutyrate"
  • Context and Importance: This term's construction is likely dispositive for infringement. If interpreted to require the presence of both calcium and magnesium BHB salts, the complaint's own evidence (the Certificate of Analysis showing "None Detected" magnesium BHB salt) would suggest non-infringement. (Compl. p. 4). If it requires only one from the group, the presence of calcium BHB appears to satisfy the limitation. Practitioners may focus on this term because the factual basis for the presence of magnesium BHB is absent from the complaint's current evidence.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation (Disjunctive - "or"): The patent's own claims may provide the strongest support for a disjunctive reading. For example, claim 14 recites a composition that "comprises only one of calcium beta-hydroxybutyrate or magnesium beta-hydroxybutyrate." (’403 Patent, col. 16:50-52). The use of "or" in a dependent or related claim to describe a subset of the components in claim 1 suggests the drafter viewed them as alternatives.
    • Evidence for a Narrower Interpretation (Conjunctive - "and"): A defendant may argue that the plain meaning of "and" connecting the two salts in the list requires both to be present. The choice to use "and" in claim 1, while using "or" in claim 14, could be presented as a deliberate distinction, suggesting that the scope of claim 1 is intended to be narrower and require both salts.

VI. Other Allegations

  • Indirect Infringement: The complaint asserts induced infringement, alleging Defendant's actions, including providing the product to customers, cause direct infringement by the end-users. (Compl. ¶28).
  • Willful Infringement: The complaint alleges willfulness based on Defendant's purported conduct after receiving "actual notice" of its infringement from Plaintiff prior to the lawsuit being filed. (Compl. ¶18, ¶29, ¶33).

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

  • A core issue will be one of claim construction: Does the phrase "selected from: calcium beta-hydroxybutyrate; and magnesium beta-hydroxybutyrate" require the presence of both salts, or is the presence of at least one salt from that two-member group sufficient to meet the limitation? The resolution of this ambiguity may determine the outcome of the infringement analysis.
  • A key evidentiary question will be one of factual presence: Assuming a construction requiring both salts, what level of precision and sensitivity does the plaintiff's third-party testing offer? The case may turn on whether "None Detected" conclusively establishes the absence of an element for infringement purposes, or if further discovery could reveal its presence.