DCT
1:24-cv-00068
Innovative Health LLC v. Vein360 LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Innovative Health, LLC (Arizona)
- Defendant: Vein360, LLC (Wyoming)
- Plaintiff’s Counsel: Ub Greensfelder LLP; POLSINELLI PC
- Case Identification: 1:24-cv-00068, S.D. Ohio, 02/13/2024
- Venue Allegations: Venue is alleged to be proper based on Defendant having a regular and established place of business in the district and having committed the alleged acts of infringement within the district.
- Core Dispute: Plaintiff alleges that Defendant’s methods for reprocessing single-use medical catheters, and the resulting products, infringe a patent related to removing and reapplying specialized coatings on such devices.
- Technical Context: The technology concerns the reprocessing of single-use medical devices, such as catheters with hydrophilic coatings, to enable safe and effective reuse, which presents potential economic advantages in the healthcare market.
- Key Procedural History: The complaint alleges Defendant received two FDA 510(k) clearance letters for the Accused Products. The patent-in-suit was issued on the same day the complaint was filed.
Case Timeline
| Date | Event |
|---|---|
| 2022-10-20 | ’730 Patent Priority Date |
| 2023-06-06 | Defendant receives first FDA 510(k) clearance letter for an Accused Product |
| 2023-10-24 | Defendant receives second FDA 510(k) clearance letter for additional Accused Products |
| 2024-02-13 | U.S. Patent No. 11,896,730 Issued |
| 2024-02-13 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,896,730 - "Reprocessing a Single-Use Medical Device"
- Patent Identification: U.S. Patent No. 11,896,730, "Reprocessing a Single-Use Medical Device", issued February 13, 2024.
The Invention Explained
- Problem Addressed: The patent’s background section describes that single-use medical devices, particularly those with lubricous coatings like catheters, can trap biological contaminants, making them difficult and unsafe to clean for reuse (’730 Patent, col. 2:1-4).
- The Patented Solution: The invention provides a multi-step method to solve this problem by first completely removing the original coating using a specific chemical process, validating its removal, preparing the now-bare surface, and then applying and validating a new coating, rendering the device suitable for reuse (’730 Patent, Abstract; col. 3:5-18).
- Technical Importance: This reprocessing method allows for the potential reuse of costly single-use medical devices, which the patent suggests can offer significant economic benefits to healthcare facilities (’730 Patent, col. 1:33-44).
Key Claims at a Glance
- The complaint asserts independent claim 1 of the ’730 patent (Compl. ¶63).
- The essential elements of independent claim 1 include:
- Removing one or more coatings from a single-use medical device by contacting the coatings with denatured ethyl alcohol.
- Validating the surface for coating removal by visually inspecting the device or using other detection methods.
- Preparing the surface for a new coating, a process which comprises:
- (i) contacting the device with a hydrogen peroxide or enzymatic solution;
- (ii) rinsing the device with water; and
- (iii) drying the device.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- The accused instrumentalities are the processes used to manufacture reprocessed medical catheters and the catheters themselves, which include the Vein360 Reprocessed Visions PV .035 Catheter, Vein360 Reprocessed Visions PV .014P RX Catheter, Vein360 Reprocessed Eagle Eye Platinum Catheter, and Vein360 Reprocessed Eagle Eye Platinum ST Catheter (collectively, the “Accused Products”) (Compl. ¶¶18, 54).
Functionality and Market Context
- The Accused Products are single-use medical devices that Defendant reprocesses for subsequent use (Compl. ¶¶32, 46). The complaint alleges that this reprocessing is necessary to obtain FDA 510(k) clearance by demonstrating "substantial equivalence" to the original, predicate device (Compl. ¶¶21-22, 26). This process allegedly involves removing a pre-existing hydrophilic coating, cleaning the device, and applying a new hydrophilic coating to ensure the device is safe and effective for reuse (Compl. ¶¶25, 29, 33-35). The image provided in the complaint depicts the Vein360 Reprocessed Visions PV .035 Catheter, one of the accused products (Compl. ¶27). Another visual from the complaint shows the Vein360 Reprocessed Eagle Eye Platinum Catheter, which is marketed as having an "enhanced hydrophilic coating" (Compl. ¶¶38-39).
IV. Analysis of Infringement Allegations
’730 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a) removing one or more coatings on a surface of the single-use medical device by contacting the one or more coatings on the surface of a single-use medical device to denatured ethyl alcohol, wherein the denatured ethyl alcohol removes the one or more coatings | Defendant allegedly removes coatings from the Accused Products by contacting them with "denatured ethyl alcohol, or equivalents thereof," based on the inference that a new coating cannot be applied without removing the old one. | ¶¶66-67 | col. 3:5-12 |
| b) validating the surface of the single-use medical device for the coating removal by visually inspecting the single-use medical device for any residual coating or using other detection methods | Defendant allegedly "validates the cleaning of single-use medical devices by inspecting the Accused Products after cleaning" and performs "hydrophilic coating integrity" testing as stated in FDA clearance letters. | ¶¶68-69, 35, 51 | col. 3:12-15 |
| c) preparing the surface of the single-use medical device for coating to form a prepared surface on the single-use medical device | Defendant allegedly prepares the device surface as a necessary prerequisite to applying a new hydrophilic coating. | ¶¶70-71 | col. 3:15-18 |
| wherein preparing the surface...comprises: i. contacting the single-use medical device to a hydrogen peroxide solution or an enzymatic solution | Based on information and belief, Defendant allegedly uses "hydrogen peroxide, enzymatic solution, or equivalent thereof" to prepare the surface, inferred from FDA letters stating the cleaning operation removes "all physical soil." | ¶73, 34, 48 | col. 3:13-15 |
| ii. rinsing the single-use medical device with water | The complaint alleges that "Water is used to rinse the Accused Products." | ¶74 | col. 9:11-15 |
| iii. drying the single-use medical device | Defendant is alleged to dry the Accused Products, as its FDA clearance letters state that it performs a "drying validation." | ¶75, 34, 50 | col. 9:20-22 |
- Identified Points of Contention:
- Evidentiary Questions: The complaint's allegations regarding the use of specific chemicals ("denatured ethyl alcohol" and "hydrogen peroxide or an enzymatic solution") are made on "information and belief" and are inferred from general statements in FDA clearance letters about cleaning, soil removal, and validation (Compl. ¶¶67, 73). A central question will be what direct evidence Plaintiff can produce to show that Defendant’s process uses the specific chemicals required by the claim, rather than other cleaning agents.
- Scope Questions: The case raises the question of whether meeting a general regulatory standard like "removal of all physical soil" (Compl. ¶¶34, 48) is sufficient to meet a specific claim limitation requiring contact with "hydrogen peroxide or an enzymatic solution" (’730 Patent, cl. 1).
V. Key Claim Terms for Construction
The Term: "denatured ethyl alcohol"
- Context and Importance: This term appears in the first step of claim 1 and specifies the chemical agent for coating removal. The complaint alleges infringement via the use of this chemical "or equivalents thereof" (Compl. ¶67). Practitioners may focus on this term because the plaintiff's ability to prove literal infringement hinges on demonstrating that Defendant uses this exact substance, and the outcome of any doctrine of equivalents analysis will depend on the established scope and function of this specific limitation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification discusses the general goal of removing a coating, and mentions other solvents like isopropyl alcohol in other contexts, which a party might argue informs the context of solvents generally (’730 Patent, col. 8:44-46).
- Evidence for a Narrower Interpretation: The term itself is chemically specific. Claim 1 and the detailed description explicitly and repeatedly recite "denatured ethyl alcohol" as the agent for the claimed removal step, suggesting it was a deliberate choice by the patentee (’730 Patent, col. 3:8-9; col. 8:19-21).
The Term: "contacting the single-use medical device to a hydrogen peroxide solution or an enzymatic solution"
- Context and Importance: This defines a required sub-step for "preparing the surface." The complaint alleges infringement by inferring this action from FDA documents that refer to a validated "cleaning operation" for removing "all physical soil" (Compl. ¶¶73, 34, 48). The definition of this term is critical because if it is construed to require one of these two specific solutions, general cleaning with other agents would not infringe the claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification discusses the overall goal of cleaning and decontaminating the device surface, and mentions other detergents and decontamination agents in various embodiments, which could suggest a broader purpose of general cleaning (’730 Patent, col. 10:4-14, 60-62).
- Evidence for a Narrower Interpretation: The claim explicitly lists only two types of solutions for this step. The specification provides specific examples of this step using "3% hydrogen peroxide" or "enzymatic solutions," reinforcing the narrow and specific nature of the claim language (’730 Patent, col. 9:51-53; col. 10:15-18).
VI. Other Allegations
- Indirect Infringement: The complaint alleges direct infringement under 35 U.S.C. § 271(g), which holds a party liable for importing or selling a product in the U.S. that was made by a process patented in the U.S. (Compl. ¶76). No separate counts for induced or contributory infringement are pleaded.
- Willful Infringement: The complaint alleges that Defendant has had "actual notice and knowledge of the '730 patent since at least as early as the '730 patent's priority date," and no later than the date of filing the complaint (Compl. ¶58). The allegation of knowledge prior to the patent's issuance date is legally tenuous. The primary factual basis for willfulness appears to be knowledge acquired upon the filing and service of the complaint itself.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of evidentiary proof versus inference: Can Plaintiff produce direct evidence that Defendant's reprocessing method utilizes the specific chemicals recited in Claim 1—"denatured ethyl alcohol" and "hydrogen peroxide or an enzymatic solution"—or will its infringement theory, which relies heavily on inferences drawn from general statements in FDA 510(k) clearance documentation, fail for lack of proof?
- A key legal question will be one of claim construction versus regulatory compliance: Does satisfying a general FDA requirement for a validated "cleaning operation" that removes "all physical soil" necessarily mean that one has performed the specific, multi-step chemical process required by the patent's claims? The outcome may depend on whether the court views the claim language as a narrow recipe or as a broader functional method fulfilled by any process that achieves the same regulatory result.