DCT

1:24-cv-11373

Echosens SA v. E Scopics SAS

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-11373, D. Mass., 05/24/2024
  • Venue Allegations: Venue is asserted based on Defendant’s activities within the District of Massachusetts, including demonstrating, using, and offering to sell the accused product at a medical conference in Boston in November 2023.
  • Core Dispute: Plaintiff alleges that Defendant’s Hepatoscope device, which performs non-invasive liver assessments, infringes two patents related to devices and methods for measuring the viscoelastic properties of biological tissue using transient elastography.
  • Technical Context: The technology at issue involves non-invasive ultrasound-based systems, known as transient elastography, designed to measure tissue stiffness as a diagnostic tool, particularly for assessing the progression of liver fibrosis.
  • Key Procedural History: The complaint states that Plaintiff provided Defendant with notice of its alleged infringement of the ’592 Patent via a letter sent on or around November 20, 2023.

Case Timeline

Date Event
2017-03-27 ’592 and ’497 Patents Priority Date
2023-07-04 U.S. Patent No. 11,690,592 Issues
2023-11-10 Accused Product offered for sale in Boston, MA
2023-11-20 Notice letter regarding ’592 Patent infringement sent
2024-05-14 U.S. Patent No. 11,980,497 Issues
2024-05-24 Complaint Filed

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

U.S. Patent No. 11,690,592 - Device and Method for Measuring the Viscoelastic Properties of a Viscoelastic Medium

  • Patent Identification: U.S. Patent No. 11,690,592, issued July 4, 2023.

The Invention Explained

  • Problem Addressed: The patent describes a problem in prior art Vibration Controlled Transient Elastography (VCTE) probes where the operator's hand recoil during use can interfere with the movement of the probe tip, leading to deformed measurement pulses and results that are dependent on operator skill and are less reproducible (’592 Patent, col. 2:9-25).
  • The Patented Solution: The invention proposes an "inertial probe" where a vibrator moves a mass inside the probe casing to generate the required low-frequency pulse, rather than moving an external component (’592 Patent, col. 4:16-22). The ultrasound transducer is structurally bound to the probe casing with no relative motion (’592 Patent, col. 3:35-39). This design allows the device to measure the absolute motion of the entire probe assembly (e.g., via an accelerometer, as shown in Fig. 3) and use that data in a feedback loop to control the internal vibrator, thereby compensating for operator-induced motion and ensuring a consistently shaped pulse (’592 Patent, col. 4:51-62).
  • Technical Importance: This approach aims to improve the accuracy and reproducibility of elastography measurements by decoupling the generation of the mechanical wave from the physical instabilities of the operator holding the device (’592 Patent, col. 2:16-20).

Key Claims at a Glance

  • The complaint asserts independent claims 1 (a device) and 8 (a method) (Compl. ¶20).
  • Independent Claim 1 recites a device for transient elastography comprising:
    • A probe casing, an ultrasound transducer at the probe's tip, and a vibrator inside the casing to generate a low-frequency wave.
    • The vibrator is arranged to induce movement of the entire probe casing along its longitudinal axis.
    • The ultrasound transducer is “bound to the probe casing with no motion” relative to the casing.
    • A "component" is in "fixed relation" with the transducer, transmitting the low-frequency wave from the vibrator to the transducer to generate a shear wave in the target medium.
  • Independent Claim 8 recites a method for measuring viscoelastic properties by:
    • Positioning a probe in contact with a medium.
    • Triggering a measurement by generating a shear wave using a vibrator to emit a low-frequency wave, which is transmitted via a "component" to a transducer.
    • Using the transducer to emit ultrasound pulses to track the shear wave's propagation.
    • The method requires using a probe with the structural limitations of claim 1 (vibrator moves the casing, transducer is bound to the casing with no relative motion).
  • The complaint reserves the right to assert additional claims (Compl. ¶21).

U.S. Patent No. 11,980,497 - Device and Method for Measuring the Viscoelastic Properties of a Viscoelastic Medium

  • Patent Identification: U.S. Patent No. 11,980,497, issued May 14, 2024.

The Invention Explained

  • Problem Addressed: As a continuation of the same patent family, the ’497 Patent addresses the same technical problem of operator-induced variability and recoil in handheld transient elastography devices (’497 Patent, col. 2:14-24).
  • The Patented Solution: The ’497 Patent describes the same "inertial probe" solution as the ’592 Patent, wherein an internal vibrator moves the entire probe assembly to generate a shear wave, and the transducer is fixedly bound to the probe casing with no relative motion (’497 Patent, Abstract; col. 4:1-11).
  • Technical Importance: The invention seeks to provide more accurate and reproducible measurements independent of operator skill by controlling for the real movement of the probe during the procedure (’497 Patent, col. 14:11-16).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (a device) (Compl. ¶30).
  • Independent Claim 1 recites a device for transient elastography comprising:
    • A probe casing, an ultrasound transducer at an end of the probe, and a vibrator inside the casing.
    • The vibrator is arranged to induce a movement of the probe casing along its longitudinal axis.
    • The ultrasound transducer is “bound to the probe casing with no motion” relative to the casing.
    • The measurement is carried out by using the vibrator to generate a shear wave transmitted via the transducer, and then using the transducer to emit ultrasound pulses to track the wave.
  • The complaint reserves the right to assert additional claims (Compl. ¶31).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the Defendant's "Hepatoscope" device (Compl. ¶4).

Functionality and Market Context

  • The complaint alleges the Hepatoscope is a "specialized non-invasive ultrasound exam that measures fibrosis and steatosis within the liver using shear and transient liver elastography technology" (Compl. p. 8). A promotional image included in the complaint describes the device as an alternative to "the fibroscan," a product associated with the Plaintiff (Compl. p. 8, visual). This visual, from a purported U.S. distributor, describes the device as part of an "Onsite Liver Health Evaluation" service for medical clinics (Compl. p. 8). The complaint further alleges that the Defendant took orders for the Hepatoscope at a medical conference in Boston, MA, promoting it with an "Exclusive Launch Offer" (Compl. ¶6; p. 3, visual).

IV. Analysis of Infringement Allegations

The complaint alleges that the Defendant's Hepatoscope device infringes the patents-in-suit, but refers to non-proffered exhibits for a detailed element-by-element analysis (Compl. ¶¶21, 31). The following charts summarize the infringement allegations by mapping the general descriptions of the accused product in the complaint to the core claim elements.

’592 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a probe...adapted to carry out transient elastography measurements... The Hepatoscope is described as a device that performs "transient liver elastography technology." A promotional image shows the device being used for an "Onsite Liver Health Evaluation" (Compl. p. 8, visual). ¶20 col. 19:21-24
a probe casing; at least one ultrasound transducer arranged at a tip of the probe... and a vibrator arranged in the casing... The complaint alleges the Hepatoscope device infringes the claims, which requires the presence of these components. The device is shown with an external casing and is described as performing an "ultrasound exam" (Compl. p. 8, visual). ¶20 col. 19:25-29
the vibrator is arranged to induce a movement of the probe casing along the longitudinal axis, The infringement allegation is predicated on the assertion that the Hepatoscope operates on the "inertial probe" principle, where the internal vibrator moves the entire device. ¶20 col. 19:30-32
the at least one ultrasound transducer is bound to the probe casing with no motion of the at least one ultrasound transducer with respect to the probe casing, The allegation of infringement asserts that the Hepatoscope is constructed with the claimed fixed relationship between the transducer and casing, which distinguishes it from certain prior art devices. ¶20 col. 19:32-35
a component is connected in fixed relation with the at least one ultrasonic transducer such that the low-frequency wave generated by the vibrator is transmitted via the component to... generate a shear wave... The complaint's infringement allegation encompasses this claimed mechanism for transmitting force from the internal vibrator to the transducer to generate the measurement wave. ¶20 col. 19:35-46

’497 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a probe... adapted to carry out a transient elastography measurement... As with the ’592 patent, the Hepatoscope is alleged to be a device for performing "transient liver elastography" (Compl. p. 8, visual). ¶30 col. 19:21-24
a probe casing; at least one ultrasound transducer arranged at an end of the probe... and a vibrator arranged in the probe casing... The general allegation of infringement asserts that the Hepatoscope contains these core components as claimed. ¶30 col. 19:25-29
the vibrator is arranged to induce a movement of the probe casing along the longitudinal axis, The complaint's theory of infringement relies on the Hepatoscope employing the claimed "inertial probe" mechanism where the vibrator's action moves the entire probe casing. ¶30 col. 19:30-32
the at least one ultrasound transducer is bound to the probe casing with no motion of the at least one ultrasound transducer with respect to the probe casing, The infringement allegation asserts the Hepatoscope has the claimed structural configuration where the transducer does not move relative to the probe's body. ¶30 col. 19:33-35
the transient elastography measurement is carried out by generating the shear wave... by emitting the low-frequency wave using the vibrator and transmitted to the viscoelastic medium via the at least one transducer... The complaint alleges the Hepatoscope performs the measurement using the claimed method, where the vibrator's wave is transmitted through the fixed transducer to the patient. A promotional image shows a third party encouraging clinics to use the device for this purpose (Compl. p. 8, visual). ¶30 col. 19:36-46
  • Identified Points of Contention:
    • Structural Questions: The core of the dispute will likely center on evidentiary questions about the internal architecture of the Hepatoscope. The complaint's allegations are based on "information and belief" (Compl. ¶2). A key question is whether discovery will show that the Hepatoscope actually contains an internal vibrator that moves the entire probe casing and a transducer that is "bound to the probe casing with no motion" relative to it, as required by the claims.
    • Functional Questions: A related issue is whether the Hepatoscope, in operation, transmits the low-frequency wave from the vibrator to the transducer via "a component... connected in fixed relation," or if it uses a different mechanical linkage. The complaint does not provide specific evidence on the internal force transmission mechanism.

V. Key Claim Terms for Construction

  • The Term: "bound to the probe casing with no motion of the at least one ultrasound transducer with respect to the probe casing" (’592 Patent, Claim 1; ’497 Patent, Claim 1)

    • Context and Importance: This phrase is central to the patents' "inertial probe" concept and distinguishes the invention from prior art where the transducer moved relative to the probe handle. Infringement will depend heavily on whether the Hepatoscope's transducer has this specific fixed relationship with its housing.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The plain language of the claim suggests any method of attachment that prevents relative movement during operation would be covered. The specification states that "the ultrasound transducer is bound in motion to the probe casing" (’592 Patent, col. 4:61-63).
      • Evidence for a Narrower Interpretation: A party could argue the term is limited by the disclosed embodiments. The specification describes fixing an extremity of the transducer directly to the casing or fixing it via an interchangeable probe tip (PT) that is itself fixed to the casing (’592 Patent, col. 4:5-9; Fig. 2).
  • The Term: "a component is connected in fixed relation with the at least one ultrasonic transducer" (’592 Patent, Claim 1)

    • Context and Importance: This limitation defines the pathway for transmitting the low-frequency wave from the vibrator to the transducer. The definition of "component" and "fixed relation" will be critical to determining if the accused device's internal mechanics fall within the claim scope.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The term "component" is general. A broad reading could encompass any intermediate structure or structures that transmit the vibratory force to the transducer without relative slippage.
      • Evidence for a Narrower Interpretation: The specification discloses specific structures for this component, including "a coil of the vibrator" or "a bar" (’592 Patent, col. 19:50-52, 20:6). A defendant may argue that the term should be construed as limited to these or structurally similar embodiments.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement. The inducement allegations are based on Defendant's alleged actions to "recommend, encourage, and/or promote" the use of the Hepatoscope in an infringing manner, citing promotional activities, demonstrations, and partnership with a U.S. distributor (Compl. ¶¶22, 32). A promotional post from a third-party U.S. company describing how to use the Hepatoscope in a clinical setting is provided as evidence (Compl. p. 8). The complaint also references a user manual (Exhibit E, not provided) that allegedly instructs users on how to perform the infringing method of claim 8 of the '592 Patent (Compl. ¶24).
  • Willful Infringement: Willfulness is alleged for the ’592 Patent based on continued infringement after receiving a notice letter dated November 20, 2023 (Compl. ¶28). For both patents, willfulness is alleged based on continued infringement after the filing of the complaint (Compl. ¶¶28, 36).

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

  1. A central issue will be one of evidentiary proof: Can the Plaintiff demonstrate, through discovery, that the internal architecture of the accused Hepatoscope mirrors the specific "inertial probe" design claimed in the patents? This will require moving beyond external observations and marketing materials to prove the existence and function of the claimed internal vibrator, the fixed relationship between the transducer and casing, and the specific force transmission mechanism.

  2. The case will also likely turn on a question of claim construction: How will the court define the scope of key phrases such as "bound to the probe casing with no motion" and "a component... in fixed relation"? The outcome will depend on whether these terms are interpreted broadly according to their plain meaning or are narrowed to the specific structural embodiments detailed in the patent specifications.