Biomedical Device Consultants & Laboratories Of Colorado LLC v. Vivitro Labs Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Biomedical Device Consultants & Laboratories of Colorado, LLC (Colorado)
  • Defendant: ViVitro Labs, Inc. (Canada)
  • Plaintiff’s Counsel: Dorsey & Whitney LLP
• Case Identification: 1:23-cv-00867, D. Colo., 04/07/2023
• Venue Allegations: Venue is asserted as proper in the District of Colorado pursuant to 28 U.S.C. §§ 1391(b) and 1400(b).
• Core Dispute: Plaintiff alleges that Defendant’s heart valve durability testing system infringes a patent related to systems for the accelerated fatigue testing of prosthetic devices.
• Technical Context: The technology concerns specialized equipment for conducting high-cycle fatigue testing on prosthetic medical devices, such as heart valves, to simulate long-term use and satisfy regulatory requirements in a compressed timeframe.
• Key Procedural History: The complaint alleges that Plaintiff notified Defendant of the alleged infringement via a letter in August 2022, which included a claim chart. It further alleges that Defendant continued to offer the accused product for sale after receiving this notice.

Case Timeline

Date	Event
2009-03-06	’935 Patent Priority Date
2016-01-19	’935 Patent Issue Date
2022-08-XX	Plaintiff sends pre-suit notice letter to Defendant
2022-09-16	Defendant allegedly offers product for sale at Boston conference
2023-02-07	Defendant allegedly offers product for sale at Anaheim conference
2023-03-27	Accused product allegedly still listed on Defendant's website
2023-04-07	Complaint Filing Date

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

U.S. Patent No. 9,237,935 - "Fatigue Testing System for Prosthetic Devices"

• Issued: January 19, 2016.

The Invention Explained

• Problem Addressed: The patent describes that prior art systems for the accelerated testing of prosthetic heart valves offered minimal control over pressure spikes that occur during simulated valve closure, leading to premature device deterioration and unreliable test results (Compl. ¶2; ’935 Patent, col. 2:32-35). Additionally, existing drive mechanisms like metallic bellows or piston-cylinders were described as having issues with high operating forces, resonance at high frequencies, and seal friction, which limited test speeds and system lifespan (’935 Patent, col. 2:36-44).
• The Patented Solution: The invention is a testing apparatus designed to better manage pressure dynamics. A key feature is an "excess volume area," described as a "compliance chamber," which is placed in fluid communication with the outflow side of the test circuit (’935 Patent, col. 2:53-60). This chamber acts as a hydraulic accumulator, absorbing pressure surges during the test cycle to create more controlled, and potentially non-sinusoidal, pressure waveforms, thereby enabling more accurate and reliable high-speed testing (’935 Patent, col. 2:30-34, col. 12:4-16). Figure 3 illustrates an embodiment showing compliance chambers (135) positioned above the test samples.
• Technical Importance: The described solution allows for accelerated durability testing that more accurately simulates physiological conditions, which is a critical step for regulatory approval of prosthetic devices (’935 Patent, col. 2:21-29).

Key Claims at a Glance

• The complaint asserts independent claim 1 and dependent claims 2-4, 8, 9, and 12-13 (Compl. ¶30).
• Independent Claim 1 of the ’935 Patent recites the following essential elements:
  • A pressure source configured to drive test fluid at an accelerated rate greater than 200 beats per minute.
  • A pressurizable test chamber containing the fluid, which comprises:
    • a fluid distribution chamber on a first side of the prosthetic device.
    • a fluid return chamber on a second side of the device.
    • a fluid return conduit that structurally and fluidly connects the distribution and return chambers.
    • an excess volume area in fluid communication with the fluid return chamber, which provides a volume to store test fluid when the fluid is under compression.
• The complaint does not explicitly reserve the right to assert other claims.

III. The Accused Instrumentality

Product Identification

The accused product is the "ADC Heart Valve Durability Tester" (Compl. ¶18).

Functionality and Market Context

• The ADC Heart Valve Durability Tester is a system for performing accelerated testing of heart valve devices at frequencies up to 70 Hz (Compl. ¶21). The complaint references an "ADC Heart Valve Durability Tester" brochure, which it attaches as Exhibit B (Compl. ¶18). It alleges the product features "[i]nflow and outflow chamber annular compliance rings" that serve to "optimize differential pressure waveforms" (Compl. ¶22, citing Ex. B at 2). The complaint also references a screenshot of Defendant's website, attached as Exhibit D, which allegedly shows the product was still listed for sale as of March 27, 2023 (Compl. ¶25).
• Plaintiff alleges that it and Defendant are direct competitors in the market for cardiac-related medical device testing equipment (Compl. ¶8).

IV. Analysis of Infringement Allegations

The complaint alleges that the ADC Heart Valve Durability Tester infringes at least claim 1 of the ’935 Patent (Compl. ¶30). A claim chart was referenced as Exhibit C but was not provided with the complaint document. The narrative allegations in the complaint map features of the accused product to the elements of claim 1.

The complaint alleges the accused product meets the "pressure source" limitation because it can drive fluid at up to 70 Hz, which is above the claimed rate (Compl. ¶31). It is alleged to have a "pressurizable test chamber" with a "fluid distribution chamber" and a "fluid return chamber" on opposite sides of the test valve location (Compl. ¶31). The complaint further alleges the presence of a "fluid return conduit" that connects these chambers and an "excess volume area" that is in fluid communication with the return chamber and can store fluid under compression (Compl. ¶31). The complaint's infringement theory appears to equate the product's "annular compliance rings" (Compl. ¶22) with the claimed "excess volume area" (Compl. ¶31).

Identified Points of Contention

• Scope Questions: A central dispute may concern the construction of "excess volume area." The infringement theory will depend on whether the Defendant's "annular compliance rings" are encompassed by this term, which the patent specification primarily describes using the more specific term "compliance chamber" (’935 Patent, col. 9:8). The court may need to determine if the term is limited to the chamber-like structures disclosed or if it has a broader functional meaning.
• Technical Questions: An evidentiary question may arise regarding the fluid dynamics of the accused product. The claim requires the "excess volume area" to be "in fluid communication with the fluid return chamber" (’935 Patent, col. 17:47-48). The litigation will likely require evidence demonstrating the precise structure and fluid pathways of the accused device to determine if its "annular compliance rings" (Compl. ¶22) function in the manner required by the claim.

V. Key Claim Terms for Construction

The Term: "excess volume area"

• Context and Importance: This term appears to be the central novel feature of the invention, intended to solve the problem of pressure spikes in prior art systems. The infringement case hinges on whether the accused product's "annular compliance rings" meet this limitation. Practitioners may focus on this term because its scope will likely be determinative of infringement.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The plain language of the claim itself is functional, defining the area as being "capable of operating at the accelerated pulsed rate" and "providing a volume for storing a volume of a test system fluid when the test system fluid is under compression" (’935 Patent, col. 17:45-50). This language could support an interpretation that covers any structure performing this function.
  • Evidence for a Narrower Interpretation: The specification consistently refers to this element as a "compliance chamber" (’935 Patent, Abstract; col. 9:8) and describes specific embodiments containing a compressible gas or an elastomeric material (’935 Patent, col. 18:21-29). A defendant may argue that these specific disclosures limit the scope of the term to a more substantial chamber structure, rather than a "ring."

The Term: "fluid return conduit"

• Context and Importance: This term defines the architecture of the fluid circuit. The claim requires it to "both structurally and fluidly connect[] the fluid distribution chamber to the fluid return chamber" (’935 Patent, col. 17:42-44). The accuracy of the complaint's mapping of the accused device's fluid path to this element will be critical.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The claim language is primarily functional, not specifying a particular location or shape for the conduit. This may support a construction covering any fluid path that serves the connecting function.
  • Evidence for a Narrower Interpretation: The patent figures and detailed description show a "central return flow channel" or "telescoping center conduit" that is positioned centrally among the test samples (e.g., element 124 in Fig. 3; ’935 Patent, col. 4:32-34). A party could argue that this consistent depiction limits the term to a centrally located conduit.

VI. Other Allegations

Indirect Infringement

The prayer for relief seeks to enjoin Defendant from "inducing others to infringe" (Compl. p. 9), but the complaint does not plead a separate count for indirect infringement or allege specific facts detailing how Defendant instructs its customers to infringe. The allegations focus on direct infringement by offering to sell and importing the product (Compl. ¶29).

Willful Infringement

The complaint alleges willful infringement based on Defendant's alleged pre-suit knowledge of the ’935 Patent (Compl. ¶39). The basis for this allegation is a letter and claim chart Plaintiff's counsel allegedly sent to Defendant in August 2022, followed by Defendant’s continued offers for sale at trade shows in September 2022 and February 2023 (Compl. ¶24-25, ¶39).

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

• A core issue will be one of definitional scope: can the claim term "excess volume area," which the patent specification describes as a "compliance chamber," be construed broadly enough to read on the accused product's "annular compliance rings"?
• A key evidentiary question will be one of technical mapping: does the evidence show that the accused product's internal fluid circuit and "annular compliance rings" are structured and operate in a way that meets the specific connection and communication requirements of the asserted claim, particularly the requirement for the "excess volume area" to be in fluid communication with the "fluid return chamber"?
• The outcome of the willfulness claim will likely depend on the substance of the pre-suit correspondence alleged in the complaint and whether Defendant's subsequent actions can be characterized as objectively reckless disregard of a known risk of infringement.