DCT
2:23-cv-04291
Biomedical Device Consultants & Laboratories Of Colorado LLC v. Vivitro Labs Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Biomedical Device Consultants & Laboratories of Colorado, LLC (Colorado)
- Defendant: ViVitro Labs, Inc. (Canadian Corporation)
- Plaintiff’s Counsel: Dorsey & Whitney LLP
- Case Identification: 1:23-cv-0867, D. Colo., 04/07/2023
- Venue Allegations: Plaintiff alleges venue is proper because Defendant is a foreign corporation, subject to personal jurisdiction for this action under Fed. R. Civ. P. 4(k), and may therefore be sued in any judicial district.
- Core Dispute: Plaintiff alleges that Defendant’s ADC Heart Valve Durability Tester infringes a patent related to systems for the accelerated fatigue testing of prosthetic medical devices.
- Technical Context: The technology involves laboratory equipment that simulates physiological conditions to perform high-cycle durability testing on prosthetic heart valves, a necessary step for regulatory approval.
- Key Procedural History: The complaint alleges Plaintiff sent Defendant a letter in August 2022, providing notice of U.S. Patent No. 9,237,935 and a claim chart alleging infringement. It further alleges that despite this notice, Defendant continued to offer the accused product for sale in the U.S.
Case Timeline
| Date | Event |
|---|---|
| 2009-03-06 | ’935 Patent Priority Date (Provisional App. 61/158,185) |
| 2016-01-19 | ’935 Patent Issue Date |
| 2022-08 | Plaintiff allegedly sent infringement notice letter to Defendant |
| 2022-09-16 | Defendant allegedly displayed accused product at Boston conference |
| 2023-02-07 | Defendant allegedly displayed accused product at Anaheim conference |
| 2023-03-27 | Accused product allegedly 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"
- Patent Identification: U.S. Patent No. 9,237,935, "Fatigue Testing System for Prosthetic Devices," issued January 19, 2016.
The Invention Explained
- Problem Addressed: The patent’s background section states that prior art prosthetic valve testing systems, particularly those using metallic bellows or piston-and-cylinder drives, had difficulty producing non-sinusoidal pressure waveforms needed for accurate physiological simulation, especially at accelerated speeds. This could lead to uncontrolled pressure spikes, damaging test samples and causing false failures. (Compl. ¶2, 14; ’935 Patent, col. 1:29-44).
- The Patented Solution: The invention is a testing apparatus that uses a drive system (e.g., a linear motor) coupled to a flexible diaphragm to cyclically pressurize a test fluid. A key feature is an "excess volume area" (described as a "compliance chamber") connected to the fluid return path. This area, which can contain a compressible gas or elastic material, absorbs pressure during the high-pressure cycle and helps regulate the fluid dynamics, dampening the pressure spikes that could damage the device being tested. (’935 Patent, Abstract; col. 2:53-57).
- Technical Importance: This approach allows for more accurate and repeatable high-frequency testing of prosthetic devices by better managing the complex fluid dynamics and pressure waveforms associated with valve closure. (Compl. ¶14; ’935 Patent, col. 2:30-39).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 2-4, 8, 9, and 12-13. (Compl. ¶23).
- Independent Claim 1 recites a device for accelerated cyclic testing of a valved prosthetic device, with 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.
- A fluid distribution chamber on a first side of the prosthetic device.
- A fluid return chamber on a second side of the prosthetic device.
- A fluid return conduit connecting the distribution and return chambers.
- An excess volume area in fluid communication with the fluid return chamber that provides a volume for storing test fluid when the fluid is under compression.
- The complaint reserves the right to assert additional claims. (Compl. ¶30).
III. The Accused Instrumentality
Product Identification
- The ADC Heart Valve Durability Tester. (Compl. ¶18).
Functionality and Market Context
- The complaint alleges 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, 31).
- It is alleged to use a "linear electromagnetic motor" as a pressure source. (Compl. ¶32, 34).
- A key feature touted in the product's marketing materials is the presence of "[i]nflow and outflow chamber annular compliance rings [that] optimize differential pressure waveforms." (Compl. ¶22).
- The complaint positions the product as a direct competitor to Plaintiff's own products and an attempt by Defendant to "re-capture the market." (Compl. ¶3, 8). The complaint alleges the product has been offered for sale and displayed at U.S. trade shows, and that at least one sales agreement has been made, though no delivery has yet occurred. (Compl. ¶19-20, 25).
IV. Analysis of Infringement Allegations
The complaint references a claim chart exhibit that was not provided with the filing. (Compl. ¶23). The narrative allegations from the complaint body are summarized below.
- ’935 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a pressure source configured to drive a test system fluid cyclically within the device... at an accelerated pulsed rate of greater than 200 beats per minute... | The accused device has a pressure source to drive fluid at up to 70 Hz, which is above a normal physiological level and exceeds the claimed rate. | ¶31 | col. 17:30-34 |
| a pressurizable test chamber for containing the test system fluid... | The accused device has a pressurizable test chamber for containing the fluid. | ¶31 | col. 17:35-37 |
| a fluid distribution chamber positioned on a first side of the valved prosthetic device and in fluid communication with the pressure source; | On one side of the prosthetic heart valve location, the device has a fluid distribution chamber in communication with the pressure source. | ¶31 | col. 17:38-41 |
| a fluid return chamber positioned on a second side of the valved prosthetic device; | On the other side of the prosthetic heart valve location, the device has a fluid return chamber. | ¶31 | col. 17:42-44 |
| a fluid return conduit both structurally and fluidly connecting the fluid distribution chamber to the fluid return chamber; | The device has a fluid return conduit that structurally and fluidly connects the distribution and return chambers. | ¶31 | col. 17:45-48 |
| an excess volume area... in fluid communication with the fluid return chamber providing a volume for storing a volume of a test system fluid when the test system fluid is under compression. | The device has an excess volume area in communication with the fluid return chamber that can store fluid when under compression. The complaint identifies the "annular compliance rings" as satisfying this limitation. | ¶22, 31 | col. 17:49-55 |
No probative visual evidence provided in complaint.
- Identified Points of Contention:
- Scope Questions: A central dispute may revolve around the proper construction of "excess volume area." The complaint alleges that the accused product's "annular compliance rings" meet this limitation. (Compl. ¶22). The court will need to determine if this claim term, described in the patent specification as a "compliance chamber," is broad enough to read on the specific structure of the accused "annular compliance rings."
- Technical Questions: The complaint alleges the "annular compliance rings" function to "optimize differential pressure waveforms." (Compl. ¶22). A technical question will be whether this function is the same as "providing a volume for storing a volume of a test system fluid when the test system fluid is under compression," as required by the claim. (’935 Patent, col. 17:53-55).
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 damaging pressure spikes. (Compl. ¶2, 14). The infringement case may turn on whether the accused product's "annular compliance rings" (Compl. ¶22) fall within the scope of this term. Practitioners may focus on this term because its construction will likely dictate the outcome of the infringement analysis.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself is functional, defining the area by what it does: "providing a volume for storing a volume of a test system fluid when the test system fluid is under compression." (’935 Patent, col. 17:53-55). The specification also states that the purpose of the "compliance chambers" is to "absorb some of the pressure placed upon the fluid" and "act as a resilient spring force to dampen the effects of large, quickly changing pressure gradients." (’935 Patent, col. 9:11-14, 26-29). This functional description could support a broader meaning encompassing various structures that perform the same role.
- Evidence for a Narrower Interpretation: The specification repeatedly refers to this element as a "compliance chamber" (’935 Patent, col. 2:54), which is depicted as a distinct cavity. (’935 Patent, Fig. 3, element 135). Dependent claims 9, 10, 11, and 12 further define the "excess volume area" as a "compliance chamber" that may contain "a compressible gas," an "elastomeric membrane," or "a porous material." (’935 Patent, col. 18:28-44). A defendant may argue that these more specific disclosures limit the scope of the term to the particular embodiments described, rather than any component that mitigates pressure changes.
VI. Other Allegations
- Indirect Infringement: The prayer for relief requests an injunction against inducing infringement, but the body of the complaint does not allege specific facts to support a claim for inducement, such as evidence that Defendant instructs its customers to operate the accused product in an infringing manner. (Compl. ¶39, Prayer for Relief ¶A).
- Willful Infringement: The complaint alleges willful infringement based on Defendant's alleged knowledge of the ’935 Patent since at least August 2022, when Plaintiff sent a notification letter with a claim chart. The complaint alleges that Defendant continued to offer the product for sale after receiving this notice. (Compl. ¶24-25, 39).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: Will the claim term "excess volume area," described in the patent as a "compliance chamber," be construed broadly based on its stated function of dampening pressure, or will it be limited to the specific cavity-like structures disclosed in the patent's embodiments? The answer will likely determine if the accused "annular compliance rings" infringe.
- A second issue will be one of pre-suit conduct: The complaint alleges pre-suit notice was provided in August 2022. The court will examine the content of that notice and Defendant’s subsequent actions—including displaying the product at trade shows—to determine whether the alleged infringement, if any, was willful.
- An evidentiary question will be one of commercial activity: The complaint alleges offers for sale, importation for trade shows, and at least one sales agreement, but no deliveries. (Compl. ¶18-20). The extent and nature of Defendant’s commercial activities in the U.S. will be a key factual determination for establishing infringement under 35 U.S.C. § 271(a) and calculating any potential damages.