DCT
2:23-cv-00634
Axcess Global Sciences v. Nutriana
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Axcess Global Sciences LLC (Utah)
- Defendant: Nutriana LLC (Wyoming); One Family LLC (Michigan); and Jonathan Jesper (an individual)
- Plaintiff’s Counsel: Workman Nydegger
- Case Identification: 2:23-cv-00634, D. Utah, 09/18/2023
- Venue Allegations: Plaintiff alleges venue is proper based on a prior settlement agreement between the parties that designated the U.S. District Court for the District of Utah as the exclusive venue for resolving disputes.
- Core Dispute: Plaintiff alleges that Defendant’s ketogenic dietary supplements infringe patents related to specific mixed-salt formulations of beta-hydroxybutyrate (BHB).
- Technical Context: The technology involves exogenous ketone supplements designed to help consumers achieve or maintain a state of nutritional ketosis while mitigating the electrolyte imbalances that can accompany ketogenic diets.
- Key Procedural History: The complaint alleges that the parties entered into a settlement agreement in 2022 to resolve a prior dispute concerning infringement of Plaintiff's patents and trademarks. Plaintiff alleges that Defendants breached this agreement by continuing to sell infringing products, which may bear on the questions of pre-suit knowledge and willfulness.
Case Timeline
| Date | Event |
|---|---|
| 2016-03-11 | Priority Date for ’403 and ’362 Patents |
| 2021-06-01 | ’362 Patent Issued |
| 2022-02-08 | ’403 Patent Issued |
| 2022-06-30 | Deadline for Defendants to cease sales under prior Settlement Agreement |
| 2022-07-11 | Plaintiff's first alleged notice of breach of Settlement Agreement |
| c. 2022-10-01 | Launch of reformulated "New Product" version of Nutriana Keto BHB |
| 2023-09-18 | Complaint Filing Date |
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 February 8, 2022)
The Invention Explained
- Problem Addressed: The patent's background describes the difficulty of transitioning into and sustaining a ketogenic state, noting that this process is often accompanied by adverse physiological effects like the "low-carb flu" and, critically, electrolyte imbalances which can be exacerbated by consuming ketone supplements composed of a single salt. (’403 Patent, col. 2:20-61, col. 4:8-20).
- The Patented Solution: The invention is a composition of beta-hydroxybutyrate (BHB) that combines several different salt forms (e.g., sodium, potassium, calcium, magnesium). This mixed-salt approach is designed to provide exogenous ketones to induce or sustain ketosis while also delivering a "biologically balanced set of cationic electrolytes," thereby mitigating the negative side effects associated with ketosis and single-salt supplements. (’403 Patent, Abstract; col. 4:58-65).
- Technical Importance: This technology purports to make ketogenic diets more sustainable and tolerable by providing a method to elevate blood ketone levels without disrupting the body's essential electrolyte balance. (’403 Patent, col. 4:8-15).
Key Claims at a Glance
- The complaint asserts independent claim 1. (Compl. ¶¶ 6, 131).
- Essential elements of Claim 1:
- A composition for increasing ketone level in a subject, comprising:
- a plurality of beta-hydroxybutyrate salts comprised of:
- at least one beta-hydroxybutyrate salt selected from: calcium beta-hydroxybutyrate; and magnesium beta-hydroxybutyrate; and
- at least one other beta-hydroxybutyrate salt selected from a list that includes sodium, potassium, calcium, and magnesium beta-hydroxybutyrate;
- wherein the beta-hydroxybutyrate salts comprise at least 20% by total weight of calcium beta-hydroxybutyrate and/or magnesium beta-hydroxybutyrate;
- wherein the composition is in solid and/or powder form;
- wherein the composition is 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: As with the related ’403 patent, the specification describes the physiological challenges of achieving ketosis, with a particular focus on the disruption of normal electrolyte balances that often occurs when transitioning into and maintaining a ketogenic state. (’362 Patent, col. 2:32-51).
- The Patented Solution: The patent discloses mixed-salt BHB compositions that aim to induce ketosis while simultaneously providing a balanced profile of electrolytes. This is intended to avoid the "detrimental health effects associated with imbalanced electrolyte ratios" that can arise from both the ketogenic state itself and from poorly formulated supplements. (’362 Patent, Abstract; col.4:58-65).
- Technical Importance: The invention offers a way to supplement with exogenous ketones that is designed to be physiologically balanced, potentially enhancing the safety and tolerability of ketogenic lifestyles for a broader population. (’362 Patent, col. 4:8-15).
Key Claims at a Glance
- The complaint asserts independent claim 1. (Compl. ¶¶ 5, 149).
- Essential elements of Claim 1:
- A composition for increasing blood ketone level in a subject, comprising:
- at least three beta-hydroxybutyrate salts selected from: sodium beta-hydroxybutyrate; potassium beta-hydroxybutyrate; calcium beta-hydroxybutyrate; and magnesium beta-hydroxybutyrate;
- wherein the composition is in solid and/or powder form;
- wherein the composition is free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof.
III. The Accused Instrumentality
- Product Identification: The complaint identifies "Nutriana Keto BHB Advanced Formula" ("Nutriana Keto BHB") as the accused instrumentality. (Compl. ¶4). It specifies that Defendants sold an "Original Product" before October 2022 and subsequently began selling a reformulated "New Product" under the same name and Amazon Standard Identification Number (ASIN). (Compl. ¶¶ 45-46).
- Functionality and Market Context: The accused product is a dietary supplement sold in capsule form and marketed to support nutritional ketosis. (Compl. ¶133). The complaint presents visual evidence of two different formulations: an "Original Product" containing sodium, calcium, and magnesium BHB salts, and a "New Product" containing calcium and magnesium BHB salts but omitting sodium BHB and adding apple cider vinegar and raspberry ketones. (Compl. ¶¶ 3, 6, 73). A side-by-side comparison image in the complaint highlights the differences in the "Supplement Facts" panels of the two versions. (Compl. ¶73, p. 29). The products are sold online, including on Amazon.com, where they allegedly compete with Plaintiff's own licensed products. (Compl. ¶¶ 4, 18).
IV. Analysis of Infringement Allegations
11,241,403 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition for increasing ketone level in a subject... | The product is marketed as "ketone supplements for ketosis" that "help utilize fat for fuel." | ¶133 | col. 15:40-41 |
| a plurality of beta-hydroxybutyrate salts comprised of: at least one beta-hydroxybutyrate salt selected from: calcium beta-hydroxybutyrate; and magnesium beta-hydroxybutyrate... | The accused product's "Supplement Facts" label lists "Calcium (as Calcium Beta-Hydroxybutyrate)" and "Magnesium (as Magnesium Beta-Hydroxybutyrate)." | ¶134 | col. 16:1-5 |
| ...and at least one other beta-hydroxybutyrate salt selected from: sodium..., potassium..., calcium..., magnesium... | The complaint alleges the presence of "Magnesium beta-hydroxybutyrate" satisfies this limitation. | ¶134 | col. 16:1-5 |
| wherein the beta-hydroxybutyrate salts comprise at least 20% by total weight of calcium beta-hydroxybutyrate and/or magnesium beta-hydroxybutyrate... | The complaint alleges this limitation is met but does not provide calculations based on the product's proprietary blend formulation. | ¶135 | col. 16:7-10 |
| wherein the composition is in solid and/or powder form... | The product is a capsule containing powder, and the complaint cites an online Q&A where a user is advised they can "pour the powder" from the capsule. | ¶136 | col. 16:11-12 |
| wherein the composition is free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof. | The ingredients list shown for the accused product does not include medium chain fatty acids, glycerides, or other esters. | ¶137 | col. 16:13-16 |
- Identified Points of Contention:
- Technical Question: A key factual dispute will be the precise composition of the accused product's proprietary blend. The complaint does not provide the evidentiary basis (e.g., specific weights of each BHB salt) to confirm that the calcium and/or magnesium salts constitute "at least 20% by total weight" of all BHB salts present, as required by claim 1. This determination will likely require discovery and testing.
11,020,362 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition for increasing blood ketone level in a subject... | The product is marketed as "ketone supplements for ketosis." | ¶150 | col. 15:1-2 |
| at least three beta-hydroxybutyrate salts selected from: sodium beta-hydroxybutyrate; potassium beta-hydroxybutyrate; calcium beta-hydroxybutyrate; and magnesium beta-hydroxybutyrate... | The complaint provides evidence that the "Original Product" formulation contained sodium, calcium, and magnesium beta-hydroxybutyrate. A provided image of a "Supplement Facts" label lists "Magnesium Beta-Hydroxybutyrate (as goBHB®)", "Calcium Beta-Hydroxybutyrate (as goBHB®)", and "Sodium Beta-Hydroxybutyrate (as goBHB®)". | ¶151 | col. 15:3-8 |
| wherein the composition is in solid and/or powder form... | The product is sold as capsules containing powder. The complaint references an online Q&A discussing treating the pills "as a powder." | ¶152 | col. 15:9-10 |
| wherein the composition is free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof. | The accused product's disclosed ingredient list does not contain medium chain fatty acids. | ¶153 | col. 15:11-14 |
- Identified Points of Contention:
- Scope Question: The complaint's infringement allegation for the ’362 Patent appears to rely on the formulation of the "Original Product," which contained three required BHB salts. (Compl. ¶151, p. 60). However, the complaint also states that Defendants now sell a "New Product" containing only two of the listed salts (calcium and magnesium). (Compl. ¶73, p. 29). This raises the question of whether the currently sold product infringes claim 1 of the ’362 patent, which requires "at least three" salts from the specified list.
V. Key Claim Terms for Construction
The Term: "at least three beta-hydroxybutyrate salts" (from '362 Patent, Claim 1)
Context and Importance: This term is critical because the infringement case for the ’362 Patent appears to depend on it. The "Original Product" allegedly met this limitation, while the "New Product" appears not to. The court's interpretation of this seemingly straightforward numerical requirement will determine whether the currently sold product can infringe.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: A party might argue the specification's focus is on creating a "biologically balanced set of cationic electrolytes," suggesting the spirit of the invention is a mixture, not a strict number, although this is a difficult argument against plain numerical language. (’362 Patent, col. 5:26-31).
- Evidence for a Narrower Interpretation: The claim language itself provides a clear numerical floor of "at least three," which is unambiguous. The patent consistently uses the term "plurality" in the abstract and summary but selected the more specific "at least three" for this claim, suggesting a deliberate choice. (’362 Patent, col. 15:3).
The Term: "wherein the beta-hydroxybutyrate salts comprise at least 20% by total weight of calcium beta-hydroxybutyrate and/or magnesium beta-hydroxybutyrate" (from '403 Patent, Claim 1)
Context and Importance: This quantitative limitation is a central element of claim 1 of the ’403 Patent. Proving that the accused product meets this specific weight percentage will be essential for the plaintiff's infringement case. Practitioners may focus on this term because its verification depends entirely on the undisclosed composition of a proprietary blend.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The use of "and/or" suggests flexibility, allowing the 20% threshold to be met by calcium BHB alone, magnesium BHB alone, or the sum of the two.
- Evidence for a Narrower Interpretation: The specification provides multiple examples where calcium and magnesium salts make up a substantial portion of the total salt mix (e.g., Example 3 has them at a combined 65% of the mix), suggesting that a significant, not incidental, amount was contemplated by the inventor. (’403 Patent, col. 13:41-43).
VI. Other Allegations
- Indirect Infringement: The complaint alleges that Defendants induce infringement, asserting that they had actual knowledge of the asserted patents. This knowledge is allegedly based on the parties' prior settlement agreement and subsequent written notices of infringement sent by Plaintiff. (Compl. ¶¶ 139, 155).
- Willful Infringement: The complaint alleges that the infringement was willful. The basis for this allegation is that Defendants were allegedly aware of the patents, had expressly promised in the settlement agreement not to infringe related patents, and continued their allegedly infringing activities even after receiving further written notice from Plaintiff. (Compl. ¶¶ 141, 157).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central factual issue will be one of evidentiary proof: What is the precise weight-based composition of the accused "New Product's" proprietary blend? The infringement finding for the '403 patent depends on whether the product's calcium and magnesium BHB salts meet the "at least 20% by total weight" limitation, a fact that will require discovery to establish.
- A primary legal issue will be one of claim scope: Can the "New Product," which the complaint indicates contains only two types of BHB salts, be found to infringe claim 1 of the '362 patent, which explicitly requires "at least three" salts from a designated list? The viability of the infringement claim against the currently marketed product under this patent may turn on this question.
- A critical question for damages will be the impact of prior dealings: How will the alleged existence of a prior settlement agreement and subsequent notices of infringement affect a potential finding of willfulness? The defendants' state of mind in relation to the prior agreement will be a focal point in determining whether the alleged infringement, if found, was egregious enough to warrant enhanced damages.