DCT

1:24-cv-11373

Echosens SA v. E Scopics SAS

Key Events
Amended Complaint
complaint Intelligence

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-11373, D. Mass., 03/31/2025
  • Venue Allegations: Venue is based on the Defendant's alleged infringing activities within the District of Massachusetts, including importing, demonstrating, and offering its product for sale at "The Liver Meeting" conference in Boston in November 2023.
  • Core Dispute: Plaintiff alleges that Defendant's Hepatoscope medical device infringes two U.S. patents related to non-invasive methods and devices for measuring the viscoelastic properties of biological tissue.
  • Technical Context: The technology at issue is transient elastography, a non-invasive ultrasound-based method used to measure tissue stiffness, which is a key diagnostic tool for assessing liver fibrosis.
  • Key Procedural History: The complaint alleges that Defendant was provided with pre-suit notice of infringement of the '592 patent via a letter sent on or around November 20, 2023. The '497 patent issued on May 14, 2024, after the original complaint was filed, and the Amended Complaint details alleged infringing activities that occurred after this issuance date.

Case Timeline

Date Event
2017-03-27 '592 and '497 Patents Priority Date
2023-07-04 '592 Patent Issue Date
2023-11-01 Defendant demonstrates Accused Product at TLM23 in Boston, MA
2023-11-20 Plaintiff sends notice letter to Defendant regarding '592 Patent
2024-05-14 '497 Patent Issue Date
2024-05-18 Defendant markets Accused Product at DDW conference
2024-06-21 Defendant markets Accused Product at ADA conference
2024-10-01 Arizona Liver Health advertises preceptorship program with Accused Product
2024-11-01 Defendant demonstrates Accused Product at TLM24 conference
2025-03-01 Defendant plans to demonstrate Accused Product at Desert Liver Conference
2025-03-31 Amended Complaint Filing Date

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

The Invention Explained

  • Problem Addressed: The patent describes that traditional transient elastography probes can suffer from reproducibility issues due to operator-dependent variables, such as the amount of applied force and the recoil of the operator's hand when the device actuates (ʼ592 Patent, col. 2:8-21). In these prior art devices, the motion of the internal vibrating tip is measured relative to the probe's outer casing, not relative to the patient's body, which can introduce measurement errors (ʼ592 Patent, col. 2:1-8).
  • The Patented Solution: The invention is an "inertial probe" where an internal vibrator is designed to induce movement in the entire probe casing as a single unit (ʼ592 Patent, col. 3:29-33). The ultrasound transducer is bound to the casing with no relative motion (ʼ592 Patent, abstract). By measuring the absolute movement of the probe casing itself (e.g., with an accelerometer), the system can precisely control the shear wave generated in the tissue, compensating for operator-induced motion and improving measurement accuracy and reproducibility (ʼ592 Patent, col. 4:50-65).
  • Technical Importance: This design aims to standardize non-invasive liver stiffness measurements by minimizing the impact of operator skill, thereby improving the reliability of a key diagnostic for liver disease (ʼ592 Patent, col. 5:9-14).

Key Claims at a Glance

  • The complaint asserts independent claims 1 (a device) and 8 (a method) (Compl. ¶20).
  • Independent Claim 1 requires, among other elements:
    • A probe casing containing a vibrator.
    • An ultrasound transducer bound to the probe casing with "no motion" relative to the casing.
    • The vibrator is arranged to induce a movement of the entire probe casing along its longitudinal axis.
    • A "component" in fixed relation with the transducer, through which the low-frequency wave from the vibrator is transmitted to the transducer to generate a shear wave in the medium.
  • Independent Claim 8 recites a method of using a device with the structural characteristics outlined in claim 1.
  • 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

The Invention Explained

  • Problem Addressed: The '497 Patent, a continuation of the '592 patent's family, addresses the same core problem of operator variability in transient elastography measurements (ʼ497 Patent, col. 2:14-25).
  • The Patented Solution: The '497 Patent claims the same "inertial probe" concept as the '592 Patent, where the entire probe casing is moved by an internal vibrator and the transducer is fixed to the casing (ʼ497 Patent, abstract). It further describes using a force sensor to ensure proper contact is made with the tissue before a measurement is triggered, which is formalized by the generation of a "measurement ready signal" (ʼ497 Patent, abstract; '497 Patent, col. 5:35-50).
  • Technical Importance: This adds a layer of automated quality control by using force-sensing to confirm proper probe application, further enhancing the potential for reproducible diagnostic measurements (ʼ497 Patent, col. 6:1-10).

Key Claims at a Glance

  • The complaint asserts independent claim 1 (a device) (Compl. ¶30).
  • Independent Claim 1 requires, among other elements:
    • A probe casing containing a vibrator.
    • An ultrasound transducer arranged at an end of the probe.
    • 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 generating a shear wave via the vibrator and tracking it with the transducer.
  • The complaint reserves the right to assert additional claims (Compl. ¶31).

III. The Accused Instrumentality

Product Identification

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

Functionality and Market Context

  • The Hepatoscope is described as an "ultraportable ultrasound imaging system" designed for non-invasive liver assessment (Compl. ¶30; Compl. ¶43). It consists of a handheld probe connected to a tablet or laptop that displays the user interface and measurement results (Compl. ¶6). An advertisement from a third-party distributor, included in the complaint, describes the Hepatoscope as a "specialized non-invasive ultrasound exam that measures fibrosis and steatosis within the liver using shear and transient liver elastography technology" (Compl. ¶24). This advertisement shows the Hepatoscope device in use.
  • The complaint alleges the Hepatoscope is marketed as a direct competitor to Plaintiff's own "FibroScan®" product (Compl. ¶38). Defendant is alleged to have promoted and demonstrated the Hepatoscope at numerous medical conferences in the U.S. and to have established a U.S. sales presence (Compl. ¶¶5-6; Compl. ¶¶33-44). The complaint also notes that the Hepatoscope is FDA-cleared (Compl. ¶46).

IV. Analysis of Infringement Allegations

'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 probe comprising: a probe casing; at least one ultrasound transducer...and a vibrator... The Hepatoscope is a probe-based system that its own manual states is for performing measurements including "soft tissue elasticity imaging" and measuring "shear wave speed and tissue stiffness." ¶21, Ex. C p. 2 col. 3:17-24
the vibrator is arranged to induce a movement of the probe casing along the longitudinal axis, The complaint alleges, citing a related patent application from the Defendant, that the Hepatoscope's vibrator causes movement of the entire probe casing along its longitudinal axis. ¶21, Ex. C p. 8 col. 3:32-36
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 complaint alleges the transducer is fixed to the casing, citing a related patent application from the Defendant that describes the transducer and housing as "mechanically integral" and constituting a "single mass." ¶21, Ex. C p. 11 col. 3:37-40
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 the at least one ultrasonic transducer to generate a shear wave... The complaint alleges that the probe housing or an internal chassis part serves as the claimed "component" that transmits the vibrator's energy to the transducer. ¶21, Ex. C p. 12 col. 3:41-48
the transient elastography measurement is carried out by generating the shear wave in the viscoelastic medium...and by emitting...a plurality of ultrasounds pulses to track a propagation of the shear wave... The Defendant's user manual is alleged to describe this exact process: the probe creates shear waves that propagate into internal organs, and the system performs a series of ultrasound acquisitions to track and measure their speed. ¶21, Ex. C p. 13 col. 4:22-30

'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, the probe comprising: a probe casing; at least one ultrasound transducer...and a vibrator... The Hepatoscope is a probe-based device that promotional materials and its manual describe as performing transient elastography to measure liver stiffness. ¶31, Ex. D p. 3 col. 1:20-24
the vibrator is arranged to induce a movement of the probe casing along the longitudinal axis, The complaint alleges that the Hepatoscope's internal electrodynamic vibrator is arranged to induce movement of the entire probe casing along its longitudinal axis. ¶31, Ex. D p. 8 col. 3:32-36
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, Promotional videos and images allegedly show the transducer is fixed within the probe casing. The complaint includes an image from a promotional video showing the internal construction where the ultrasound array appears bound to the casing. ¶31, Ex. D p. 10 col. 3:37-40
the transient elastography measurement is carried out by generating the shear wave...by emitting the low-frequency wave using the vibrator...and by emitting...a plurality of ultrasounds pulses to track a propagation of the shear wave... The user manual for the Hepatoscope is cited as describing this process, stating the vibrator creates shear waves and the probe performs ultrasound acquisitions to track tissue displacement and measure shear wave speed. ¶31, Ex. D p. 12 col. 18:1-9
  • Identified Points of Contention:
    • Scope Questions: For the '592 Patent, a central issue may be the construction of the "component" limitation in claim 1. The complaint's theory is that the probe casing itself can be the claimed "component." A question for the court will be whether this limitation requires a structurally distinct element from the probe casing, or if the integrated body of the probe satisfies the claim's functional language. The '497 Patent lacks this "component" limitation, which may alter the infringement analysis for that patent.
    • Technical Questions: For both patents, a key factual question may be what constitutes "no motion" of the transducer relative to the casing. The infringement allegation rests on the idea of a rigid, "mechanically integral" unit. The analysis may turn on evidence regarding the actual physical behavior of the accused device during operation and whether any de minimis or incidental relative movement between the transducer and casing exists. The complaint provides a photo from a conference showing the accused product being used on a person, which is cited as evidence of infringing use (Compl. ¶34).

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" (asserted in claim 1 of both patents).

    • Context and Importance: This term is the technological core of the "inertial probe" concept, distinguishing it from prior art where the transducer moves relative to the casing. The infringement case for both patents hinges on establishing that the accused Hepatoscope has this "no motion" characteristic.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: A defendant could argue that "no motion" should be interpreted in the context of the invention's purpose, meaning no intended, functional motion for generating the shear wave, while allowing for incidental vibrations inherent in such a device. The specification does not appear to explicitly support this reading.
      • Evidence for a Narrower Interpretation: The specification provides strong support for a strict, literal interpretation. It states that "the ultrasound transducer is bound in motion to the probe casing, which means that there is no relative movement of the ultrasound transducer with respect to the probe casing" ('592 Patent, col. 4:61-65). The complaint's exhibits also cite a related patent application from the defendant describing the transducer array as "mechanically integral with the housing" to "constitute a single mass," which may support the plaintiff's view that the term requires a rigid, fixed relationship (Compl. ¶21, Ex. C p. 11).
  • The Term: "a component is connected in fixed relation with the at least one ultrasonic transducer such that the low-frequency wave...is transmitted via the component..." ('592 Patent, claim 1).

    • Context and Importance: This limitation is present in the asserted claim of the '592 Patent but not the '497 Patent. Its interpretation is critical for the '592 infringement analysis, as the complaint alleges the probe's main housing acts as this "component."
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The specification describes the vibrator inducing movement of the entire probe casing, to which the transducer is fixed ('592 Patent, col. 3:29-40). This could support an interpretation where the casing itself is the "component" that functionally transmits the vibratory force.
      • Evidence for a Narrower Interpretation: Dependent claims specify that the "component" can be a "coil of the vibrator" or a "bar" ('592 Patent, claims 3, 6). A party might argue that these dependent claims suggest the independent claim's "component" refers to a specific structural part, not the entire probe housing, to avoid making the dependent claims redundant.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for both patents. Inducement is based on allegations that E-Scopics encourages infringement through its marketing materials, product demonstrations, and user manuals that instruct on the infringing use of the Hepatoscope (Compl. ¶¶22; Compl. ¶25; Compl. ¶32). Contributory infringement is based on allegations that the Hepatoscope is not a staple article of commerce, has no substantial non-infringing use, and was sold with knowledge of the patents (Compl. ¶25; Compl. ¶48).
  • Willful Infringement: Willfulness is alleged for both patents. For the '592 patent, the allegation is based on continued infringement after a pre-suit notice letter was allegedly received on or around November 20, 2023 (Compl. ¶28). For the '497 patent, willfulness is based on continued infringement after the patent's issuance on May 14, 2024, at which point E-Scopics was already a defendant in the litigation and thus had knowledge of the patent family (Compl. ¶51). The complaint details numerous promotional and sales-related activities in the U.S. after this date (Compl. ¶¶33-44).

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

  • A core issue will be one of claim construction: can the term "a component," as recited in claim 1 of the '592 patent, be construed to read on the main housing of the accused probe, or does it require a more specific, discrete structural element for transmitting vibratory force? The resolution of this question will be pivotal to the infringement analysis for the '592 patent.
  • A key evidentiary question will be one of technical fidelity: does the accused Hepatoscope's transducer assembly operate with "no motion" relative to its casing, as required by the claims of both patents? The case may turn on expert testimony and technical evidence demonstrating the precise physical interactions within the accused device during operation.
  • Finally, the dispute raises a question of commercial damages: given the alleged head-to-head competition with Plaintiff's FibroScan® product, a central issue will be whether Plaintiff can establish the necessary factors for a lost profits claim, or if damages will be limited to a reasonable royalty.
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