DCT
0:17-cv-03403
Biomedical Device Consultants & Laboratories Of Colorado LLC v. Ta Instruments Waters LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Biomedical Device Consultants & Laboratories of Colorado, LLC (Colorado)
- Defendant: TA Instruments - Waters LLC (Delaware)
- Plaintiff’s Counsel: Dorsey & Whitney LLP
- Case Identification: 0:17-cv-03403, D. Minn., 07/27/2017
- Venue Allegations: Venue is alleged to be proper based on Defendant maintaining a regular and established place of business in Minnesota, referred to as "TA Electroforce," where it allegedly manufactures, tests, and services the infringing products.
- Core Dispute: Plaintiff alleges that Defendant’s ElectroForce line of cardiovascular test products, specifically the DuraPulse system, infringes four patents related to accelerated fatigue testing systems for prosthetic medical devices.
- Technical Context: The technology involves systems for simulating physiological conditions to perform accelerated durability and wear testing on prosthetic devices like heart valves, a critical step in their development and approval.
- Key Procedural History: The complaint alleges a detailed history of pre-suit notice. Plaintiff’s predecessor was notified of infringement in July 2014. After Defendant acquired the relevant business unit in 2015, Plaintiff notified Defendant directly in February 2016. The complaint also alleges that Defendant was independently aware of the patents-in-suit, as they were cited during the prosecution of Defendant’s own patent applications, a fact that may be significant for the willfulness allegations.
Case Timeline
| Date | Event |
|---|---|
| 2009-03-06 | Earliest Priority Date for all Patents-in-Suit ('538, '708, '224, '935) |
| 2013-11-19 | U.S. Patent No. **8,584,538** Issued |
| 2014-01-14 | U.S. Patent No. **8,627,708** Issued |
| 2014-07-01 | (Approx.) BDC sends notice letter to Defendant's predecessor (Bose Corp.) |
| 2015-01-01 | (Approx.) Defendant acquires ElectroForce Systems division from Bose Corp. |
| 2015-11-17 | U.S. Patent No. **9,186,224** Issued |
| 2015-12-01 | (Approx.) Defendant begins advertising the accused DuraPulse product |
| 2016-01-19 | U.S. Patent No. **9,237,935** Issued |
| 2016-02-23 | BDC sends notice letter to Defendant reiterating infringement concerns |
| 2017-07-27 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,584,538 - "Fatigue Testing System for Prosthetic Devices," Issued Nov. 19, 2013
The Invention Explained
- Problem Addressed: Prior methods for fatigue testing of prosthetic devices, such as heart valves, typically used rotary motors or metallic bellows. These systems were often limited to producing simple sinusoidal pressure waves, struggled to accurately simulate more complex physiological conditions, and had limited operational lifespans in high-cycle testing applications due to friction and resonance issues (’538 Patent, col. 1:26-44).
- The Patented Solution: The invention uses a computer-controlled linear drive motor coupled to a flexible, low-inertia "rolling bellows" diaphragm. This combination allows the system to generate complex, non-sinusoidal pressure waveforms that can more accurately mimic physiological conditions at accelerated speeds, while avoiding the wear and friction issues of conventional piston-cylinder systems (’538 Patent, Abstract; col. 2:11-20). The system is designed to be highly controllable and variable to test a range of different devices (’538 Patent, col. 1:50-65).
- Technical Importance: This approach enabled more realistic and accelerated life-cycle testing of prosthetic devices by moving beyond simple wave patterns to customizable, physiologically-relevant pressure and flow profiles (’538 Patent, col. 2:30-37).
Key Claims at a Glance
- The complaint asserts independent claims 1, 6, and 10 (Compl. ¶21).
- Independent Claim 1 (System):
- A testing system for... valved prosthetic devices comprising:
- a test chamber;
- a signal generator that outputs a non-regular waveform over a cycle for controlling a rate of change of a differential pressure load;
- a drive motor configured to operate in response to the non-regular waveform; and
- a fluid displacement member connected with and driven by the drive motor to displace fluid in the test chamber.
- Independent Claim 10 (Method):
- A method for accelerated cyclic testing... comprising:
- generating an asymmetric waveform over a test cycle;
- driving a motor acyclically in response to the asymmetric waveform;
- reciprocally moving a fluid displacement member... to provide a pressure source that increases and decreases a pressure on fluid; and
- controlling a rate of change of a differential pressure load across the... valved prosthetic devices.
- The complaint also asserts dependent claims 2-5, 7-9, and 11-14 (Compl. ¶21).
U.S. Patent No. 8,627,708 - "Fatigue Testing System for Prosthetic Devices," Issued Jan. 14, 2014
The Invention Explained
- Problem Addressed: The patent addresses the same general problem as the ’538 patent: the limitations of prior art systems in accurately simulating physiological conditions for accelerated device testing (’708 Patent, col. 1:26-44).
- The Patented Solution: This patent focuses on the structural arrangement of the test chamber itself. It describes an integrated chamber formed by a fluid distribution chamber and a fluid return chamber, connected by a central return conduit. The system includes "compliance chambers" which hold a gas or elastomeric material to act as a spring, absorbing pressure spikes and controlling recoil, thereby dampening pressure gradients and allowing for more precise control over the testing environment (’708 Patent, Abstract; col. 8:55-65).
- Technical Importance: This chamber design provides a self-contained, regulated hydraulic circuit that enables stable and repeatable high-speed testing by actively managing fluid dynamics and pressure transients within the system (’708 Patent, col. 9:1-9).
Key Claims at a Glance
- The complaint asserts independent claim 17 (Compl. ¶34).
- Independent Claim 17 (Test Chamber):
- A test chamber for accelerated cyclic testing... in a variable pressurized environment comprising:
- a fluid distribution chamber having a first manifold defining a first port;
- a fluid return chamber having a second manifold disposed opposite the first;
- a fluid return conduit structurally and fluidly connecting the distribution chamber to the return chamber; and
- a compliance chamber providing a volume for holding a gas or elastomeric material that compresses under pressure.
- The complaint also asserts dependent claims 21-23 (Compl. ¶34).
Multi-Patent Capsule: U.S. Patent No. 9,186,224
- Patent Identification: U.S. Patent No. 9,186,224, "Fatigue Testing System for Prosthetic Devices," Issued Nov. 17, 2015.
- Technology Synopsis: This patent claims a method for operating an accelerated test system. The method involves driving test fluid at a rate well above normal physiological levels (e.g., >200 BPM) and includes steps of storing a volume of the fluid in an "excess volume area" during the driving stroke (opening the test valve) and then releasing that stored volume during the return stroke (closing the test valve) (’224 Patent, col. 3:13-24).
- Asserted Claims: Independent claim 1 and dependent claim 6 (Compl. ¶41).
- Accused Features: The complaint alleges the DuraPulse infringes by operating at high frequencies (15-30 Hz), storing working fluid in an excess volume area during the driving stroke, and releasing it on the return stroke (Compl. ¶42).
Multi-Patent Capsule: U.S. Patent No. 9,237,935
- Patent Identification: U.S. Patent No. 9,237,935, "Fatigue Testing System for Prosthetic Devices," Issued Jan. 19, 2016.
- Technology Synopsis: This patent claims a testing device with a specific structural configuration. Key elements include a pressure source, a pressurizable test chamber, a fluid distribution chamber, a fluid return chamber, a conduit connecting them, and an "excess volume area" in fluid communication with the return chamber that can store fluid under compression (’935 Patent, Claim 1).
- Asserted Claims: Independent claim 1 and dependent claims 2, 3, 8, 9, and 12 (Compl. ¶53).
- Accused Features: The complaint alleges the DuraPulse embodies this structure, possessing a pressure source, a pressurizable test chamber, a fluid distribution chamber, a fluid return chamber, a connecting conduit, and an excess volume area for storing compressed fluid (Compl. ¶54).
III. The Accused Instrumentality
Product Identification
The accused products are Defendant's "ElectroForce line of cardiovascular test products," with a specific focus on the "DuraPulse Heart Valve Test" system ("DuraPulse") (Compl. ¶12-13).
Functionality and Market Context
The DuraPulse is a system for performing accelerated wear and fatigue testing of heart valve devices (Compl. ¶13). The complaint alleges, based on Defendant's own marketing materials, that the DuraPulse features "[u]nmatched waveform control," "precise control of displacements, forces, and pressures," and a "flexible control system" (Compl. ¶12). It allegedly tests devices at frequencies from 15 to over 30 Hz, well beyond normal physiological rates, with software for defining and displaying test conditions (Compl. ¶13). The complaint references a product brochure to describe the DuraPulse as a system for accelerated testing of valved prosthetic devices, showing its test chamber and ability to generate specific waveforms (Compl. ¶22).
IV. Analysis of Infringement Allegations
’538 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a test chamber | The DuraPulse system includes a test chamber for performing accelerated testing of valved prosthetic devices. | ¶22 | col. 4:36-38 |
| a signal generator that outputs a non-regular waveform over a cycle for controlling a rate of change of a differential pressure load... | The DuraPulse generates a non-regular waveform to test prosthetic heart valves. | ¶22 | col. 17:9-14 |
| a drive motor configured to operate in response to the non-regular waveform | The DuraPulse has a drive motor that operates in response to the non-regular waveform. | ¶22 | col. 17:15-17 |
| a fluid displacement member connected with and driven by the drive motor to displace fluid in the test chamber in response to the non-regular waveform | The DuraPulse has a fluid displacement member, which the drive motor drives to displace fluid in the test chamber. | ¶22 | col. 17:18-21 |
- Identified Points of Contention:
- Scope Questions: The case may turn on whether the accused system's "flexible control system" and ability to create "periodic waveforms for fatigue tests" (Compl. ¶12) falls within the patent's claim scope of a "non-regular waveform" or "asymmetric waveform." The definition will depend on how different a waveform must be from a standard sine wave to be considered "non-regular."
- Technical Questions: A factual question may be whether the accused "fluid displacement member" operates as a "rolling bellows diaphragm" as described in the patent's preferred embodiment, or if it uses a different mechanism that might not be equivalent.
’708 Patent Infringement Allegations
| Claim Element (from Independent Claim 17) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A test chamber for accelerated cyclic testing... in a variable pressurized environment comprising a fluid distribution chamber having a first manifold... | The DuraPulse is a device for performing accelerated testing in a pressurized environment and has a fluid distribution chamber with a manifold. | ¶35 | col. 19:8-14 |
| a fluid return chamber having a second manifold disposed opposite and spaced apart from the first manifold... | The DuraPulse has a fluid return chamber with a manifold disposed opposite the first manifold. | ¶35 | col. 19:15-18 |
| a fluid return conduit both structurally and fluidily connecting the fluid distribution chamber to the fluid return chamber | The ports at the top and bottom of the sample holder connect the fluid distribution chamber and the fluid return chamber. | ¶35 | col. 19:19-22 |
| and a compliance chamber providing a volume for holding a gas or elastomeric material that compresses under a pressure placed upon fluid... | The DuraPulse has a compliance chamber where gas is held, which compresses under pressure. A YouTube video is referenced to show the internal components of the accused device, including its fluid distribution and return chambers (Compl. ¶35). | ¶35 | col. 19:23-28 |
- Identified Points of Contention:
- Scope Questions: The infringement analysis will likely focus on whether the accused device contains a "compliance chamber" as claimed. The dispute may center on whether any open volume in the accused device that compresses under pressure meets the claim's functional requirement of "providing a volume for holding a gas or elastomeric material that compresses" to dampen pressure gradients.
- Technical Questions: Evidence will be required to demonstrate that the various alleged chambers and conduits in the DuraPulse are structurally and fluidly connected in the specific arrangement required by claim 17.
V. Key Claim Terms for Construction
For the ’538 Patent
- The Term: "non-regular waveform"
- Context and Importance: This term is the central point of novelty in claim 1, distinguishing the invention from prior art systems that used simple "regular sinusoidal" waves. The entire infringement case for this claim depends on whether the waveforms generated by the DuraPulse meet this definition. Practitioners may focus on this term because it is not explicitly defined with mathematical precision, opening it to interpretation.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification contrasts the invention with the "regular sinusoidal time varying pressure field conditions" of the prior art, suggesting that any waveform that is not a simple, symmetric sine wave could be considered "non-regular" (’538 Patent, col. 1:28-34).
- Evidence for a Narrower Interpretation: The patent depicts specific examples of non-regular waveforms in Figure 7, such as a "Short Upstroke" and "Short Downstroke" (’538 Patent, Fig. 7). A defendant could argue the term is limited to waveforms with similarly asymmetric profiles, rather than any arbitrary non-sinusoidal shape.
For the ’708 Patent
- The Term: "compliance chamber"
- Context and Importance: This structure is a key element of claim 17, recited with a specific function. The viability of the infringement allegation hinges on whether the accused DuraPulse contains a structure that meets both the structural and functional requirements of this term.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language describes the chamber's function as "providing a volume for holding a gas or elastomeric material that compresses under a pressure placed upon fluid." Plaintiff may argue that any space within the accused device containing gas (e.g., air) that serves this purpose meets the definition (’708 Patent, col. 17:23-28).
- Evidence for a Narrower Interpretation: The specification describes the purpose of the compliance chambers is to "act as a resilient spring force to dampen the effects of large, quickly changing pressure gradients" (’708 Patent, col. 9:5-9). A defendant may argue this requires a specifically designed structure intended for that purpose, not just an incidental air-filled space in the system.
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement, stating Defendant markets the DuraPulse for infringing uses and provides promotional materials and user instructions that teach end-users how to perform the claimed methods (Compl. ¶26-28, 45-47). The complaint also alleges, upon information and belief, that the DuraPulse can only be used in an infringing manner, which could support a claim for contributory infringement (Compl. ¶28, 48).
- Willful Infringement: The complaint makes detailed allegations to support willfulness. It alleges pre-suit knowledge based on a February 23, 2016 notice letter (Compl. ¶24). More significantly, it alleges Defendant had independent knowledge because the ’538 and ’708 Patents were cited during the prosecution of a patent application assigned to Defendant and directed to the DuraPulse (Compl. ¶24, 36). The complaint further alleges that after receiving notice, Defendant analyzed the patents and "it appears, found that the DuraPulse infringed all of the Patents-In-Suit" (Compl. ¶16), and continued to infringe despite this knowledge and having "no reasonable defense" (Compl. ¶24, 29, 36, 43, 55).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of willfulness and intent: given the detailed allegations of pre-suit knowledge from multiple independent sources (notice letters and patent prosecution history), the case will likely focus heavily on what steps, if any, Defendant took to assess infringement after becoming aware of the patents and whether it formed a good-faith belief of non-infringement or invalidity.
- A key technical question will be one of definitional scope and equivalence: can terms like "non-regular waveform" and "compliance chamber," which are defined functionally in the patents, be construed to read on the features of the accused DuraPulse system, or is there a fundamental mismatch in technical operation and structure that would support a non-infringement defense?
- A critical evidentiary question will be one of prior communication: the complaint alleges that Defendant analyzed the patents and appeared to conclude that it infringed (Compl. ¶16). The discovery and admissibility of any such analysis or related communications could be a dispositive factor in the litigation.