2:25-cv-02071
Bioregenx Inc v. Glycocheck
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Bioregenx, Inc. (Nevada) and Microvascular Health Solutions, LLC (Delaware)
- Defendant: GLYCOCHECK US, LLC (Utah); RNL Lonepeak Holdings, LLC (Utah); Hans Vink Beheer BV. (Netherlands); GLYCOCALYX RESEARCH INSTITUTE, LLC (Utah); GENESIS HEALTH SCIENCES, LLC (Wyoming); Hans Vink (individual); Robert Long (individual)
- Plaintiff’s Counsel: Hall & Evans, LLC
- Case Identification: 2:25-cv-02071, D. Nev., 10/24/2025
- Venue Allegations: Venue is based on events giving rise to the claims occurring in the District of Nevada, alleged acts of infringement committed in the District, and Plaintiff Bioregenx, Inc. being an entity formed under Nevada law.
- Core Dispute: Plaintiffs allege that Defendants’ nutritional supplements and related business activities infringe two patents concerning compositions and diagnostic methods for supporting the endothelial glycocalyx, a protective lining of blood vessels.
- Technical Context: The technology relates to vascular health, specifically the maintenance and repair of the endothelial glycocalyx through nutritional supplements and diagnostic methodologies.
- Key Procedural History: The complaint alleges a prior business and stockholder relationship between Plaintiffs and individual Defendants Hans Vink and Robert Long, which provided Defendants with access to proprietary information. Plaintiffs allege that after the individual Defendants' employment was terminated in October 2023, Defendants began marketing infringing products and continued to do so despite receiving cease-and-desist letters in May 2024.
Case Timeline
| Date | Event |
|---|---|
| 2007-11-30 | U.S. Patent No. 8,759,095 Priority Date |
| 2014-06-24 | U.S. Patent No. 8,759,095 Issues |
| 2015-04-08 | U.S. Patent No. 9,943,572 Priority Date |
| 2018-04-17 | U.S. Patent No. 9,943,572 Issues |
| 2023-10-13 | Defendant Robert Long's employment terminated |
| 2023-10-16 | Defendant Hans Vink resigns |
| 2023-11-10 | Defendants informed of license agreement termination |
| 2024-05-15 | Plaintiffs send cease-and-desist letters to Defendants |
| 2025-10-24 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,943,572 - "SYNERGISTIC GLYCOCALYX TREATMENT COMPOSITIONS AND METHODS"
- Patent Identification: U.S. Patent No. 9,943,572, issued April 17, 2018 (’572 Patent).
The Invention Explained
- Problem Addressed: The patent addresses the problem of a damaged or "leaky" endothelial glycocalyx, which can lead to microvascular endothelial dysfunction, inflammation, and other negative vascular health indicators (’572 Patent, col. 1:56-2:9). A damaged glycocalyx is associated with the leakage of substances like cholesterol into the subendothelial space (’572 Patent, col. 2:1-3).
- The Patented Solution: The invention is a synergistic composition designed to repair, protect, and synthesize new glycocalyx (’572 Patent, col. 2:14-23). The solution combines nutritional "building blocks" (like glucosamine), "glycocalyx mimetics" for acute repair (like hyaluronan and fucoidan), and antioxidants (like superoxide dismutase) to combat degradation from oxidative stress (’572 Patent, Abstract; Fig. 4). This multi-pronged approach is alleged to be more effective than its individual components (’572 Patent, col. 2:30-36).
- Technical Importance: The invention provides an oral, multi-component nutritional supplement approach to maintaining a critical, but fragile, component of vascular health that was not previously well understood (’572 Patent, col. 1:33-35).
Key Claims at a Glance
- The complaint asserts "one or more claims" of the ’572 Patent (Compl. ¶44). The lead independent claims appear to be Claim 1 and Claim 17.
- Independent Claim 1 (Method of Treatment):
- Administering to a mammal a composition comprising:
- one or more molecular precursor of endothelial glycocalyx, comprising glucosamine;
- one or more antioxidant that associates with endothelial glycocalyx, comprising superoxide dismutase; and
- one or more glycocalyx mimetic selected from a group consisting of a nonsulfated glycosaminoglycan, hyaluronan, a sulfated polysaccharide, and fucoidan.
U.S. Patent No. 8,759,095 - "DIAGNOSTIC AND THERAPEUTIC TOOLS FOR DISEASES ALTERING VASCULAR FUNCTION"
- Patent Identification: U.S. Patent No. 8,759,095, issued June 24, 2014 (’095 Patent).
The Invention Explained
- Problem Addressed: The patent identifies an urgent need for diagnostic tools capable of detecting the vulnerability of blood vessel walls to atherogenic stimuli and other vascular diseases, particularly before symptoms become severe (’095 Patent, col. 1:53-64).
- The Patented Solution: The invention provides methods for assessing the status of the endothelial glycocalyx non-invasively by analyzing microvascular blood flow (’095 Patent, col. 3:51-61). A key method involves capturing images of red blood cells (RBCs) flowing through a microvessel and creating a size distribution of the RBC column width; the difference between the maximum width (representing the vessel wall) and the median width (representing the typical RBC path) reveals the thickness of the glycocalyx layer (’095 Patent, col. 19:12-45; Fig. 4). This diagnostic assessment can then guide therapeutic interventions (’095 Patent, col. 5:46-56).
- Technical Importance: The patented method allows for a quantitative, non-invasive assessment of glycocalyx health, providing a functional biomarker for vascular disease risk and therapeutic response (’095 Patent, col. 20:7-13).
Key Claims at a Glance
- The complaint asserts "one or more claims" of the ’095 Patent (Compl. ¶53). The lead independent claims appear to be Claim 1 and Claim 5.
- Independent Claim 1 (Method of Reconstituting):
- A method for reconstituting the integrity of a glycocalyx, comprising the steps of:
- (i) assessing the status of the glycocalyx by determining RBC widths in microvascular blood vessels; and
- (ii) reconstituting the integrity of the glycocalyx when the assessment indicates it is compromised.
III. The Accused Instrumentality
Product Identification
The complaint accuses Defendants of "promoting and selling products that are identical to the patented technology and core formulation protected under the ‘572 Patent" (Compl. ¶30). It also accuses products that "contain the same or substantially the same combination of ingredients claimed in the ‘095 patent" (Compl. ¶52). These products are allegedly sold through websites operated by Defendants, including one under the name "Glycocalyx Research Institute" (Compl. ¶31).
Functionality and Market Context
The accused instrumentalities are described as nutritional supplements focused on glycocalyx health, directly competing with Plaintiffs' products (Compl. ¶31). The complaint alleges Defendants used their prior relationship with Plaintiffs to gain access to proprietary research and formulations to create these competing products (Compl. ¶29). The complaint further alleges that Defendants unlawfully copied "large portions of Plaintiffs' original website, including layout, images, product descriptions, [and] scientific explanations" to market their products (Compl. ¶37). The complaint references an exhibit comparing the parties' websites to demonstrate this alleged copying (Compl. ¶100, n.8).
IV. Analysis of Infringement Allegations
The complaint references but does not attach claim chart exhibits detailing its infringement contentions (Compl. ¶42, n.4; ¶51, n.5). The following analysis is based on the narrative allegations in the complaint.
’572 Patent Infringement Allegations
- Narrative Theory: The complaint alleges that Defendants have "made, used, sold, offered for sale, and/or imported products that contain the same or substantially the same combination of ingredients claimed in the ‘572 patent" (Compl. ¶43). This constitutes an allegation of direct infringement under 35 U.S.C. § 271(a) (Compl. ¶44). The core of this allegation is a direct compositional overlap between the accused products and the elements of the claims, such as the combination of a glycocalyx precursor, an antioxidant, and a glycocalyx mimetic.
- Identified Points of Contention:
- Evidentiary Question: What evidence will be presented to establish that Defendants' products contain the specific combination of ingredients (glucosamine, superoxide dismutase, hyaluronan/fucoidan) required by the independent claims?
- Scope Question: How will the parties interpret claim terms such as "molecular precursor," "antioxidant that associates with endothelial glycocalyx," and "glycocalyx mimetic," and do the ingredients in the accused products fall within those definitions?
’095 Patent Infringement Allegations
- Narrative Theory: The complaint alleges that Defendants have "made, used, sold, offered for sale, and/or imported products that contain the same or substantially the same combination of ingredients claimed in the ‘095 patent" (Compl. ¶52). This is alleged to be direct infringement (Compl. ¶53).
- Identified Points of Contention:
- Scope Question: A central issue may arise from the mismatch between the asserted claims and the infringement allegation. The independent claims of the ’095 Patent are directed to methods of diagnosis and treatment (e.g., "A method for reconstituting the integrity of a glycocalyx" comprising an "assessing" step). The complaint, however, accuses a product ("products that contain... ingredients") of infringement. This raises the question of whether the sale of a nutritional supplement can, by itself, directly infringe a multi-step method claim that includes a diagnostic assessment.
- Technical Question: What evidence does the complaint provide that Defendants perform, or that their products are used to perform, the specific diagnostic step of "assessing the status of the glycocalyx" by measuring red blood cell widths in microvessels as required by Claim 1?
V. Key Claim Terms for Construction
For the ’572 Patent
- The Term: "glycocalyx mimetic" (Claim 1)
- Context and Importance: This term defines a key functional component of the claimed composition. The scope of this term will be critical to determining if the ingredients in Defendants' products, particularly any alleged hyaluronan or fucoidan, perform the claimed "mimetic" function for acute repair. Practitioners may focus on this term to dispute whether an ingredient merely present in a supplement is capable of acting as a "mimetic" at a site of damage.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim itself provides examples, stating the mimetic is "selected from the group consisting of a nonsulfated glycosaminoglycan, hyaluronan, a sulfated polysaccharide, and fucoidan," which could support interpreting the term to include these specific compound classes (’572 Patent, col. 22:15-19).
- Evidence for a Narrower Interpretation: The specification describes mimetics as being used "for acute repair of damaged glycocalyx" and acting as a "patch that helps repair and maintain the backbone of the glycocalyx" (’572 Patent, col. 6:40-45; col. 10:65-col. 11:2). This could support a narrower construction requiring the ingredient to be proven to perform this specific patching and repair function in vivo.
For the ’095 Patent
- The Term: "assessing the status of the glycocalyx" (Claim 1)
- Context and Importance: This active step is the lynchpin of the claimed diagnostic method. Whether Defendants' actions meet this limitation will be central to the infringement analysis. The definition of this term is critical because the complaint accuses a product of infringement, whereas the claim requires performance of a specific diagnostic action.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The complaint does not provide sufficient detail for analysis of evidence for a broader interpretation.
- Evidence for a Narrower Interpretation: The claim explicitly defines how the assessment is performed, requiring "(a) determining the width of at least 10 Red Blood Cells in a microvascular blood vessel," followed by "(c) determining the median or average red blood cell width value" and calculating the glycocalyx width based on the difference between maximal and median values (’095 Patent, col. 32:5-24). This detailed description strongly suggests the "assessing" step requires the specific, non-invasive imaging and calculation method taught in the patent.
VI. Other Allegations
Willful Infringement
The complaint alleges willful infringement for both patents (Compl. ¶¶45, 54). The allegations are based on Defendants' alleged actual knowledge of the patents gained through their prior business relationship and direct access to Plaintiffs' proprietary technology, as well as their continued infringement after receiving cease-and-desist letters on May 15, 2024 (Compl. ¶¶29, 35, 121-122).
VII. Analyst’s Conclusion: Key Questions for the Case
- A primary evidentiary question for the ’572 Patent will be one of compositional identity: What evidence will establish that the accused nutritional supplements contain the specific combination of a glucosamine precursor, a superoxide dismutase antioxidant, and a hyaluronan or fucoidan mimetic as required by the claims?
- A core issue for the ’095 Patent will be one of infringement theory: Can the sale of a nutritional supplement product constitute direct infringement of claims directed to a multi-step method that explicitly requires a diagnostic "assessing" step involving microscopic imaging and data analysis?
- A central question for willfulness will be one of intent and knowledge: To what extent did the prior business relationship between the parties provide Defendants with knowledge of the specific patented technology, and did their conduct after termination and receipt of notice constitute objective recklessness?