DCT
0:23-cv-61429
Axcess Global Sciences LLC v. Udovytska
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Axcess Global Sciences, LLC (Utah)
- Defendant: Tetiana Udovytska and Maryna Steblianko (doing business as Vitalena Nature, et al.) (Florida)
- Plaintiff’s Counsel: Matulis IP Law; Workman | Nydegger
- Case Identification: 0:23-cv-61429, S.D. Fla., 07/26/2023
- Venue Allegations: Venue is alleged to be proper because the Defendants reside in the Southern District of Florida and have committed a substantial portion of the alleged infringements from within the District.
- Core Dispute: Plaintiff alleges that Defendant’s "Vitalena Nature Keto Burn" supplement infringes patents related to specific formulations of beta-hydroxybutyrate (BHB) mixed salts.
- Technical Context: The technology involves exogenous ketone supplements designed to help consumers achieve and maintain a state of nutritional ketosis while mitigating common side effects like electrolyte imbalance.
- Key Procedural History: The patents-in-suit are subject to terminal disclaimers, indicating they are part of a related family of patents and their terms are tied to an earlier-expiring patent. This may be relevant for claim construction and potential validity challenges based on obviousness-type double patenting.
Case Timeline
| Date | Event |
|---|---|
| 2016-03-11 | Priority Date for ’403 and ’362 Patents |
| 2021-06-01 | ’362 Patent Issue Date |
| 2022-02-08 | ’403 Patent Issue Date |
| 2023-01-01 | Alleged First Sale of Accused Products (approx.) |
| 2023-07-26 | 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 Feb. 8, 2022)
The Invention Explained
- Problem Addressed: The patent describes the significant barriers to achieving and maintaining a ketogenic state, including the difficulty of the transition period (the "low-carb flu") and the risk of electrolyte imbalances resulting from the diet's diuretic effects ('403 Patent, col. 2:7-31).
- The Patented Solution: The invention is a composition of mixed beta-hydroxybutyrate (BHB) salts designed to induce ketosis while providing a "biologically balanced set of cationic electrolytes" ('403 Patent, Abstract). By supplying exogenous ketones and key electrolytes simultaneously, the formulation aims to make the ketogenic state more attainable and sustainable for the user ('403 Patent, col. 3:1-10).
- Technical Importance: The technology sought to broaden the appeal and feasibility of ketogenic diets by directly addressing the physiological challenges that cause many individuals to abandon the diet ('403 Patent, col. 2:45-51).
Key Claims at a Glance
- The complaint asserts independent claim 1 ('403 Patent, col. 15:40-col. 16:11; Compl. ¶44).
- The essential elements of independent claim 1 include:
- A composition for increasing ketone levels, comprising a plurality of BHB salts.
- The salts must include at least one from the group of calcium BHB and magnesium BHB.
- The salts must also include at least one "other" BHB salt from a group including sodium, potassium, calcium, or magnesium BHB.
- A quantitative requirement that the salts comprise "at least 20% by total weight of calcium beta-hydroxybutyrate and/or magnesium beta-hydroxybutyrate."
- The composition must be in a "solid and/or powder form."
- The composition must be "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 Jun. 1, 2021)
The Invention Explained
- Problem Addressed: As a member of the same patent family, the '362 Patent addresses the identical problem of overcoming the negative side effects and electrolyte imbalances associated with transitioning into and maintaining a ketogenic diet ('362 Patent, col. 2:7-31).
- The Patented Solution: The invention provides mixed BHB salt compositions that supply exogenous ketones to the body while being formulated to maintain a "beneficial electrolytic balance" ('362 Patent, col. 4:64-65). The core concept is to use a specific combination of salts to avoid the health issues that can arise from an imbalanced intake of electrolytes like sodium or calcium ('362 Patent, col. 7:1-9).
- Technical Importance: This approach aimed to create a safer and more effective tool for individuals using ketogenic principles for therapeutic, weight loss, or performance-enhancement purposes ('362 Patent, col. 4:4-9).
Key Claims at a Glance
- The complaint asserts independent claim 1 ('362 Patent, col. 15:40-col. 16:5; Compl. ¶55).
- The essential elements of independent claim 1 include:
- A composition for increasing ketone levels.
- The composition must comprise "at least three beta-hydroxybutyrate salts" selected from sodium BHB, potassium BHB, calcium BHB, and magnesium BHB.
- The composition must be in a "solid and/or powder form."
- The composition must be "free of medium chain fatty acids having 6 to 12 carbons and glycerides or other esters thereof."
III. The Accused Instrumentality
Product Identification
The accused product is "Vitalena Nature Keto Burn," also referred to as "Vitalena BHB" (Compl. ¶3).
Functionality and Market Context
The product is a dietary supplement marketed for ketogenic support, with product copy including "KETO BURN" and "KETONE ENERGY" (Compl. ¶3). It is sold in capsule form, containing what the complaint alleges is an encapsulated powder (Compl. ¶14, ¶17). The complaint provides an image of the accused product's "Supplement Facts" label, listing its ingredients (Compl. ¶3, p. 2). The label identifies a proprietary blend consisting of Calcium Beta-Hydroxybutyrate (BHB), Magnesium Beta-Hydroxybutyrate (BHB), and Sodium Beta-Hydroxybutyrate (BHB), along with other inactive ingredients such as a gelatin capsule and cellulose (Compl. ¶3, p. 13).
IV. Analysis of Infringement Allegations
U.S. Patent No. 11,241,403 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition for increasing ketone level in a subject, comprising: a plurality of beta-hydroxybutyrate salts... | The accused product is marketed as "Keto Burn" and contains a blend of BHB salts. | ¶3, ¶23 | col. 15:40-42 |
| at least one beta-hydroxybutyrate salt selected from: calcium beta-hydroxybutyrate; and magnesium beta-hydroxybutyrate... | The product label discloses the presence of both Calcium BHB and Magnesium BHB. | ¶3, ¶44 | col. 15:43-46 |
| and at least one other beta-hydroxybutyrate salt selected from: sodium beta-hydroxybutyrate... | The product label discloses the presence of Sodium BHB. | ¶3, ¶44 | col. 15:47-53 |
| 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 provides no quantitative analysis, as the ingredients are in a "Proprietary Blend." | ¶44 | col. 15:54-57 |
| wherein the composition is in solid and/or powder form... | The product is sold as an "encapsulated powder." | ¶14, ¶44 | col. 15:58-59 |
| wherein the composition is free of medium chain fatty acids... | The product’s "Other Ingredients" list does not disclose any medium chain fatty acids, glycerides, or other esters. | ¶3, ¶44 | col. 15:60-63 |
- Identified Points of Contention:
- Factual Question: A central dispute will be whether Plaintiff can prove the "at least 20% by total weight" limitation is met. Because the accused product's label lists the active ingredients in a "Proprietary Blend" without specifying weights or ratios, this allegation currently lacks direct evidentiary support in the complaint and will depend on discovery and likely chemical analysis of the product.
- Scope Question: The meaning of the term "free of" may be contested. The parties may dispute whether it requires absolute absence of the specified compounds or merely that they are not included as functional ingredients.
U.S. Patent No. 11,020,362 Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A composition for increasing ketone level in a subject, comprising: at least three beta-hydroxybutyrate salts selected from: sodium...; potassium...; calcium...; and magnesium... | The product label discloses three salts from the claimed group: Sodium BHB, Calcium BHB, and Magnesium BHB. | ¶3, ¶55 | col. 15:40-47 |
| wherein the composition is in solid and/or powder form... | The product is sold as an "encapsulated powder." | ¶17, ¶55 | col. 16:1-2 |
| wherein the composition is free of medium chain fatty acids... | The product’s "Other Ingredients" list does not disclose any medium chain fatty acids, glycerides, or other esters. | ¶3, ¶55 | col. 16:3-5 |
- Identified Points of Contention:
- Factual Question: Unlike the '403 Patent, this claim does not have a quantitative requirement. The infringement allegation appears facially stronger, as the product label discloses three of the four listed salt types. The primary factual dispute will be confirming the composition and resolving the scope of "free of."
- Scope Question: As with the ’403 Patent, the construction of "free of" will be a key legal question.
V. Key Claim Terms for Construction
- The Term: "free of"
- Context and Importance: This term appears in the asserted independent claims of both patents. Its construction is critical because if it is construed to mean a complete, 100% absence of medium chain fatty acids, Defendants may be able to avoid infringement by showing the presence of even trace amounts in their raw materials.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discusses compositions that do include medium chain fatty acids as an additional, optional source for ketone production ('362 Patent, col. 9:8-25). A party could argue that "free of" is used to distinguish formulations that intentionally omit these precursors, not to mandate an absolute absence of incidental impurities.
- Evidence for a Narrower Interpretation: The claim language itself does not provide any qualification (e.g., "substantially free of"). A party could argue that the plain and ordinary meaning of "free of" implies a complete lack of the substance, and the patentee could have used different language if a lesser standard was intended.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement under 35 U.S.C. § 271(b) but does not plead specific facts explaining how Defendants allegedly induced their customers, such as by providing specific instructions or user manuals that direct an infringing use (Compl. ¶46, ¶57).
- Willful Infringement: The complaint alleges that infringement was "knowing and willful," based at least on the allegation that "Defendants continued to infringe after being notified of their infringement" (Compl. ¶47, ¶58). This suggests the willfulness claim is based on knowledge obtained either from a pre-suit notice or from the filing of the complaint itself.
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of compositional proof: Can the Plaintiff establish, through discovery or laboratory testing, that the "Proprietary Blend" in the accused product meets the quantitative "at least 20% by total weight" limitation required by Claim 1 of the '403 Patent? The outcome for this patent may hinge entirely on this factual determination.
- A core issue will be one of definitional scope: How will the court construe the term "free of," which is recited in both asserted patents? Whether this term requires absolute absence or merely the exclusion of functional ingredients could be outcome-determinative for infringement of both the ’403 and ’362 patents.
- A key infringement question will be the direct application of the '362 Patent claims: Does the disclosure of three distinct BHB salts (sodium, calcium, magnesium) on the accused product's label constitute direct evidence of infringement of Claim 1 of the '362 patent, pending resolution of the "free of" claim construction issue?