Koninklijke Philips NV v. OpSens Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Koninklijke Philips N.V. (Netherlands); IP2IPO Innovations, Ltd. (United Kingdom)
  • Defendant: OpSens Inc. (Canada); Haemonetics Corporation (United States)
  • Plaintiff’s Counsel: Shaw Keller LLP
• Case Identification: 1:24-cv-00206, D. Del., 02/15/2024
• Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendants have committed acts of infringement in the district, maintain regular and established places of business there, and at least one defendant entity is incorporated in the State of Delaware.
• Core Dispute: Plaintiffs allege that Defendants’ interventional cardiology systems, which perform a diagnostic measurement called "dPR," infringe a patent related to methods for assessing blood vessel blockages without the use of hyperemia-inducing drugs.
• Technical Context: The technology concerns diagnostic indices for coronary artery disease, which allow clinicians to assess the severity of a stenosis by measuring pressure inside an artery during a specific, naturally occurring phase of the cardiac cycle, avoiding the need for stress-inducing medication.
• Key Procedural History: The complaint alleges that to secure Food and Drug Administration (FDA) clearance for its accused "dPR" product, Defendant OpSens represented that its product was "equivalent to iFR (Instantaneous Wave-Free Ratio)," which is the commercial name for Plaintiffs' patented technology. Plaintiffs also note compliance with patent marking requirements via a public website.

Case Timeline

Date	Event
2011-08-20	Earliest Priority Date for U.S. Patent No. 10,912,463
2021-02-09	U.S. Patent No. 10,912,463 Issued
2024-02-15	Complaint Filed

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

U.S. Patent No. 10,912,463 - Devices, Systems, and Methods for Assessing a Vessel

• Patent Identification: U.S. Patent No. 10,912,463 ("the ’463 Patent"), titled Devices, Systems, and Methods for Assessing a Vessel, issued on February 9, 2021. (Compl. ¶14).

The Invention Explained

• Problem Addressed: The patent addresses the shortcomings of the traditional Fractional Flow Reserve (FFR) technique for assessing coronary stenosis. FFR requires the administration of hyperemic agents (vasodilating drugs) to stabilize vascular resistance, but these agents can be uncomfortable for patients, carry risks, and are not suitable for everyone. (Compl. ¶¶26-27; ’463 Patent, col. 2:2-17).
• The Patented Solution: The invention is a system and method for assessing a vessel blockage without hyperemic agents. It achieves this by obtaining pressure measurements from both proximal and distal to the stenosis and then calculating a pressure ratio within a specific "diagnostic window" of the cardiac cycle. This window is a period where vascular resistance is naturally low and stable, thereby mimicking the conditions of a hyperemic state without administering drugs. (’463 Patent, Abstract; col. 2:35-50).
• Technical Importance: This hyperemia-free approach simplifies the diagnostic procedure, reduces patient discomfort and risk, and broadens the population of patients who can be assessed for coronary artery disease. (Compl. ¶28).

Key Claims at a Glance

• The complaint asserts independent claims 1, 11, and 26. (Compl. ¶40). The right to assert other claims, including dependent claims, is implicitly reserved.
• Independent Claim 1 (System) includes:
  • A pressure-sensing guide wire and a pressure-sensing instrument.
  • A processing unit configured to receive proximal and distal pressure measurements without using a hyperemic agent.
  • The processing unit is further configured to select a diagnostic window within the cardiac cycle where the start and end points are determined based on the received pressure measurements.
  • The unit then calculates a pressure ratio using the measurements from within that window and outputs the result.
• Independent Claim 11 (System) includes:
  • A pressure-sensing guide wire and a pressure-sensing instrument.
  • A processing unit configured to receive proximal and distal pressure measurements without using a hyperemic agent.
  • The processing unit is further configured to calculate a pressure ratio for a diagnostic window, where the window's start and end points are determined based on the pressure measurements.
• Independent Claim 26 (System) includes:
  • A pressure-sensing guide wire and a pressure-sensing instrument.
  • A processing unit configured to receive proximal and distal pressure measurements without using a hyperemic agent.
  • The processing unit is further configured to select a diagnostic window and calculate a pressure ratio based on a plurality of measurements from within that window.

III. The Accused Instrumentality

• Product Identification: The Accused Products include Defendants' interventional cardiology and PCI host systems (e.g., OpSens' OptoMonitor), intravascular measurement devices (e.g., OpSens' OptoWire), and related components that collectively perform a Diastolic Pressure Ratio (“dPR”) measurement. (Compl. ¶¶34-35).
• Functionality and Market Context:
  • The accused system uses the OptoWire, a pressure guidewire, in conjunction with the OptoMonitor console to assess stenoses in vessels such as coronary arteries. (Compl. ¶35). The complaint includes a screenshot of the OptoMonitor displaying a "dPR" value, suggesting this is a key output of the system. (Compl. p. 9).
  • The complaint alleges that Defendants market their dPR product as being "just like Philips' iFR" and "equivalent to iFR." (Compl. ¶¶30-31). This is supported by a marketing graphic from Defendants that plots iFR against dPR to show a high correlation, with the caption "RESTING INDICES ARE EQUIVALENT." (Compl. p. 7). These allegations position the accused dPR functionality as a direct substitute for Plaintiffs' patented iFR technology.

IV. Analysis of Infringement Allegations

The complaint references a claim chart in Exhibit D, which was not provided with the complaint. (Compl. ¶41). Therefore, a prose summary of the infringement theory is provided below.

Plaintiffs' central theory of infringement is that Defendants' Accused Products, when used to calculate and display a "dPR" value, practice the patented method of assessing a vessel without hyperemia. The complaint alleges that the combination of the OptoWire guidewire (to measure distal pressure) and the OptoMonitor system (to process signals and display the result) constitutes an infringing system under claims 1, 11, and 26. (Compl. ¶¶34-37). The core of the allegation is that the dPR calculation necessarily involves selecting a "diagnostic window" within the diastolic phase of the cardiac cycle and calculating a pressure ratio within that window, as recited in the claims.

This theory is heavily supported by Plaintiffs' allegations that Defendants have explicitly marketed their dPR product as "equivalent to iFR," which is the commercial embodiment of the '463 Patent's technology. (Compl. ¶¶30-31). The complaint points to Defendants' own marketing materials, such as a correlation plot showing dPR and iFR are nearly identical, and submissions to the FDA as evidence that the accused dPR functionality is, by Defendants' own admission, the same as the patented iFR functionality. (Compl. p. 7; Compl. ¶31).

• Identified Points of Contention:
  • Technical Questions: A central factual question for the court will be whether the specific algorithm used by the OptoMonitor to calculate "dPR" actually performs the steps recited in the claims. Specifically, what evidence demonstrates that the accused system "select[s] a diagnostic window" where the start and end points are "determined based on... the received proximal pressure measurements or the received distal pressure measurements," as required by the independent claims?
  • Scope Questions: While the claims appear to use relatively clear terms, a dispute may arise over the precise scope of "select a diagnostic window." The case may turn on whether Defendants' method for identifying the measurement period in diastole falls within the patent's definition, which is tied to analyzing the pressure waveforms themselves.

V. Key Claim Terms for Construction

• The Term: "diagnostic window"

  • Context and Importance: This term is the technological core of the asserted claims. The infringement analysis will hinge on whether the time period over which Defendants' accused system calculates its "dPR" constitutes a "diagnostic window" as claimed. Practitioners may focus on this term because its construction will define whether any hyperemia-free diastolic ratio infringes, or only those calculated using a specific, patent-defined technique.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes the window functionally as a portion of the cardiac cycle "where the resistance is reduced without the use of a hyperemic agent," specifically identifying the "wave-free period" in the coronary arteries. (’463 Patent, col. 12:62-67).
    • Evidence for a Narrower Interpretation: The asserted independent claims require that the "starting point" and "ending point" of the window are "determined based on at least one of the received proximal pressure measurements or the received distal pressure measurements." (’463 Patent, col. 32:5-15). This language may support a narrower construction requiring that the window be actively identified by analyzing the pressure waveforms, rather than simply being a predefined portion of diastole.

• The Term: "pressure-sensing instrument"

  • Context and Importance: The system claims recite both a "pressure-sensing guide wire" (for distal pressure) and a separate "pressure-sensing instrument" (for proximal pressure). The identity and nature of this second "instrument" is critical to defining the scope of the claimed system.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discloses that the instrument for proximal measurement can be a catheter or another guide wire, suggesting the term is not limited to a single type of device. (’463 Patent, col. 7:12-18).
    • Evidence for a Narrower Interpretation: The patent also describes embodiments where proximal pressure is monitored via large-scale hemodynamic monitoring systems that are in fluid communication with a guide catheter, not a separate in-vessel instrument. (’463 Patent, col. 8:56-62). A defendant might argue that the term requires a specific type of device separate from the main console to meet this limitation.

VI. Other Allegations

• Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement allegation is based on Defendants' marketing materials and user instructions, which allegedly encourage and aid customers in using the Accused Products in an infringing manner. The contributory infringement allegation is based on the sale of products that are a material part of the invention, are especially adapted for infringement (i.e., performing the dPR calculation), and have no substantial non-infringing use. (Compl. ¶42).
• Willful Infringement: The complaint does not use the term "willful" but alleges that Defendants will have knowledge of the '463 Patent and their infringement "at least as of the date of service of this Complaint." (Compl. ¶42). The prayer for relief seeks enhanced damages and attorney fees, which may be awarded in cases of willful or exceptional infringement. (Compl. ¶¶43.D, 43.F).

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

This case appears to center on the following key questions:

1. A central issue will be one of technical and factual proof: Does the accused OpSens dPR algorithm operate in a manner that meets the specific claim limitation of "select[ing] a diagnostic window" based on an analysis of pressure waveforms? Plaintiffs will likely argue that Defendants' own marketing claims of "equivalence" to the patented iFR technology serve as an admission, while Defendants may argue that their proprietary method is technically distinct and non-infringing.

2. A secondary issue will be one of definitional scope: What is the proper construction of "diagnostic window"? The outcome will determine whether the claims cover a broad category of hyperemia-free diastolic pressure ratios or are limited to ratios calculated using the specific waveform-analysis techniques detailed in the patent specification.