DCT

6:24-cv-00556

Rex Medical LP v. Ethicon Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 6:24-cv-00556, W.D. Tex., 10/18/2024
  • Venue Allegations: Plaintiff alleges venue is proper in the Western District of Texas because Defendant Ethicon Endo-Surgery, Inc. owns and operates a facility in El Paso, Texas, and because the Accused Products are manufactured in Juarez, Mexico, imported into the U.S. through ports of entry in the District, and are subsequently warehoused, sold, and used within the District.
  • Core Dispute: Plaintiff alleges that Defendant’s surgical stapler and sealer products infringe three patents related to apparatuses and methods for simultaneously resecting and sealing tissue.
  • Technical Context: The technology involves minimally invasive surgical devices capable of cutting and stapling or sealing tissue, which are fundamental tools in high-volume procedures such as bariatric, thoracic, and colorectal surgeries.
  • Key Procedural History: The complaint alleges an extensive history of pre-suit communications, including notice letters and a detailed presentation to Defendant regarding the patents-in-suit. Notably, the patentability of asserted claims of the '650 Patent was previously challenged and confirmed in an inter partes review (IPR) proceeding at the Patent Trial and Appeal Board, a factor which may influence the patent's presumption of validity in this litigation.

Case Timeline

Date Event
2001-01-31 Priority Date for ’650, ’892, and ’033 Patents
2016-09-13 U.S. Patent No. 9,439,650 ('650 Patent) Issued
2016-09-13 Plaintiff provides notice of the '650 Patent to Defendant
2018-11-27 U.S. Patent No. 10,136,892 ('892 Patent) Issued
2019-12-03 Plaintiff provides notice of the '650 and '892 Patents to Defendant
2020-06-09 U.S. Patent No. 10,675,033 ('033 Patent) Issued
2020-07-01 Plaintiff provides notice of the '033 Patent to Defendant
2022-05-10 Inter Partes Review Certificate Issued for '650 Patent (IPR2020-00152)
2024-10-18 Complaint Filed

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

U.S. Patent No. 9,439,650 - "Apparatus and Method for Resectioning Gastro-Esophageal Tissue," issued September 13, 2016

The Invention Explained

  • Problem Addressed: The patent’s background section describes the limitations of prior art endoscopic surgical staplers, including their restricted range of motion, which complicates procedures within confined anatomical spaces like the esophagus (Compl. ¶ 19; ’650 Patent, col. 1:36-45).
  • The Patented Solution: The invention is a surgical apparatus, operable via a control handle that remains outside the patient, featuring a pair of movable jaws at its distal end for clamping tissue. One jaw carries staples and the other provides an anvil surface to form them ('650 Patent, Abstract). A key aspect is a mechanism for fine approximation of the jaws, such as a translating clamping member, to ensure tissue is held securely and properly aligned for simultaneous stapling and cutting ('650 Patent, col. 4:65-68).
  • Technical Importance: The ability to perform simultaneous cutting and sealing through a minimally invasive approach was a significant development for reducing patient trauma and recovery time in major surgeries (Compl. ¶ 19).

Key Claims at a Glance

  • The complaint asserts at least claim 6, which is dependent on independent claim 4 (Compl. ¶ 122).
  • The essential elements of independent claim 4 include:
    • A first jaw and a second jaw, movable with respect to each other from a first configuration (to receive tissue) to a second configuration (to hold tissue for stapling).
    • A staple carrying portion on the first jaw with slots for staples to pass through.
    • An anvil surface on the second jaw opposing the first jaw.
    • At least one of a gear and a cable operatively coupled to the jaws to move them between the first and second configurations.
    • A staple pusher configured to move staples out of the carrying portion.
    • A beam configured to engage the jaws from within to maintain alignment and distance while tissue is stapled.
  • The complaint notes that the accused products also infringe additional, unspecified claims of the '650 Patent (Compl. ¶ 138).

U.S. Patent No. 10,136,892 - "Apparatus and Method for Resectioning Gastro-Esophageal Tissue," issued November 27, 2018

The Invention Explained

  • Problem Addressed: The patent targets the same general problem as the '650 Patent: enabling effective and precise minimally invasive tissue resection and sealing ('892 Patent, col. 1:39-41).
  • The Patented Solution: This patent discloses an apparatus with a more specific jaw actuation system, comprising two distinct assemblies: a "first adjustment assembly configured for gross movement" and a "second adjustment assembly... configured for fine movement" ('892 Patent, Claim 1). The fine movement assembly includes a beam with a central web, upper and lower portions, and an integrated cutting blade, which engages channels within the jaws to maintain a fixed distance and alignment during firing ('892 Patent, col. 5:16-30; col. 6:58-63).
  • Technical Importance: The claimed separation of "gross" and "fine" adjustment mechanisms suggests a design focused on giving surgeons enhanced precision in positioning and clamping tissue before committing to stapling and cutting.

Key Claims at a Glance

  • The complaint asserts at least independent claims 1 and 5 (Compl. ¶¶ 146, 159).
  • The essential elements of independent claim 1 include:
    • A head with movable first and second jaws.
    • A first adjustment assembly for gross movement.
    • A second adjustment assembly including a beam with a central web (with a cutting blade), upper/lower portions, and coupled to a pusher for fine movement.
    • A handle with one or more actuators.
    • A shaft coupling the handle to the head.
    • A specific geometry wherein at least one beam portion is a "generally flat plate orthogonally attached" to the central web and engages a jaw "entirely from within."
    • A specific alignment wherein the pusher and central web are "coplanar with a channel defined in a tissue contacting surface" of the jaws.
  • Independent claim 5 describes a similar apparatus focused on a beam for sealing tissue, also requiring specific geometric relationships, such as at least one beam portion being "orthogonally attached" to the central web and the pusher being "coplanar" with the web and channel.
  • The complaint notes infringement of other unspecified, additional claims of the '892 Patent (Compl. ¶ 168).

U.S. Patent No. 10,675,033 - "Apparatus and Method for Resectioning Gastro-Esophageal Tissue," issued June 9, 2020

Technology Synopsis

  • The '033 Patent describes a surgical apparatus for tissue stapling and sealing, also featuring a beam with upper, lower, and central web portions. A key feature is a "linear pusher having a distal end entirely and fixedly coupled to the beam," which moves the beam distally to trigger a separate staple pusher ('033 Patent, Claim 1). The beam is specified to engage the jaws "below an outermost surface" to clamp and align them, a potentially distinct configuration from the "from within" language of the other patents (Compl. ¶¶ 177, 187).

Asserted Claims

  • At least independent claim 1 and independent claim 19 (Compl. ¶¶ 176, 186).

Accused Features

  • The "Accused Stapler Products" are alleged to infringe claim 1, while the "Accused Sealer Products" are alleged to infringe claim 19, suggesting Plaintiff is mapping different claims to different product lines (Compl. ¶¶ 176, 186).

III. The Accused Instrumentality

Product Identification

  • The complaint identifies two categories of accused devices, collectively termed the "Accused Products" (Compl. ¶ 94).
    • Accused Stapler Products: These include the ECHELON+ Powered Stapler, ECHELON FLEX Powered Vascular Stapler, ECHELON FLEX ENDOPATH Stapler, and their associated reload cartridges (Compl. ¶ 36).
    • Accused Sealer Products: These include the ENSEAL G2 Articulating Tissue Sealer, ENSEAL G2 Curved Tissue Sealer, and ENSEAL G2 Straight Tissue Sealer (Compl. ¶ 93).

Functionality and Market Context

  • The complaint alleges these are surgical instruments designed to simultaneously cut and seal tissue using staples or energy (e.g., cauterization) (Compl. ¶¶ 19, 30, 36, 93). Their primary application is in minimally invasive laparoscopic procedures (Compl. ¶ 19).
  • Plaintiff alleges the Accused Products are widely used in hundreds of thousands of bariatric, thoracic, and colorectal surgeries annually in the United States, positioning them as commercially significant products in the medical device market (Compl. ¶¶ 38-40).

IV. Analysis of Infringement Allegations

’650 Patent Infringement Allegations

Claim Element (from Independent Claim 4) Alleged Infringing Functionality Complaint Citation Patent Citation
a first jaw and a second jaw, at least one of the first jaw and the second jaw being movable with respect to the other ... from a first configuration ... to receive tissue and a second configuration ... to hold tissue there between for stapling, The Accused Stapler Products have two jaws, at least one of which is movable to clamp tissue. This is shown in a marketing video depicting the jaws moving from an open to a closed state (Compl. p. 19). ¶128 col. 4:5-15
a staple carrying portion of the first jaw defining slots through which staples are configured to pass; The first jaw of the Accused Stapler Products contains a "Reload channel" which holds staples and has slots for them to pass through (Compl. p. 19). ¶129 col. 4:5-6
an anvil surface defined on the second jaw opposing the first jaw; The second jaw has an anvil surface with pockets to form the staples after they pass through the tissue. This is shown in an image labeled "ONE PIECE ANVIL CONSTRUCTION" (Compl. p. 19). ¶130 col. 4:6-7
at least one of a gear and a cable operatively coupled to at least one of the first jaw and the second jaw and configured to move at least one of the first jaw and the second jaw from the first configuration to the second configuration such that the first jaw and the second jaw are in alignment; and The complaint alleges the accused products use a gear and/or cable mechanism to move the jaws into alignment for stapling, citing a marketing video showing the internal gear mechanism (Compl. p. 20). ¶131 col. 5:10-21
a staple pusher configured to cause a staple to move ... to a second position entirely outside the staple carrying portion... The accused products have a staple pusher that moves staples out of the reload cartridge to staple tissue. ¶132 col. 6:11-15
a beam configured to engage the first and second jaws from within the first and second jaws while tissue is stapled from a proximal location to a distal location. A beam, shown in a "3-Point Gap Control" diagram (Compl. p. 21), allegedly engages the jaws from within to maintain alignment and a fixed distance during firing. This diagram shows the beam traveling longitudinally within channels in the upper and lower jaws. ¶133-134 col. 6:30-46
  • Identified Points of Contention:
    • Scope Question: A likely point of contention will be the term "beam configured to engage the first and second jaws from within." The infringement case will depend on whether the "3-Point Gap Control" mechanism of the accused ECHELON products, which appears to ride in channels inside the jaw structures, meets this "from within" limitation as it is construed by the court.
    • Technical Question: What evidence demonstrates that the accused gear and cable mechanism performs the specific function of moving the jaws into alignment, as required by the claim, rather than simply actuating the firing sequence?

’892 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
a head having a first jaw and a second jaw, at least one of the first jaw and the second jaw being movable... The accused products have a head with two movable jaws. ¶150 col. 4:4-10
a first adjustment assembly configured for gross movement of the first jaw or the second jaw; The complaint does not explicitly map a feature to "gross movement" but alleges infringement of all limitations. This element's satisfaction may be inferred from the general operation of opening and closing the jaws. ¶148 col. 5:1-5
a second adjustment assembly including a beam configured for fine movement... wherein the beam is operatively coupled to a pusher and includes a central web portion connecting an upper beam portion and a lower beam portion, the central web portion including a cutting blade... The accused products allegedly have an assembly with a beam for "fine movement" to maintain a fixed distance, which includes a central web and a cutting blade. This is depicted in the "ONE PIECE ANVIL" visual (Compl. p. 26). ¶154 col. 5:16-30
a handle having one or more actuators configured to move at least one of the first jaw and the second jaw... and to actuate the stapling assembly; and a shaft coupling the handle to the head; The accused products have a handle with actuators to move the jaws and a shaft connecting the handle to the head. The complaint provides an image showing the handle and the elongated shaft (Compl. p. 28). ¶156-157 col. 4:1-3
at least one of the upper beam portion and the lower beam portion is a generally flat plate orthogonally attached to an end of the central web portion and is configured to engage the first jaw or the second jaw entirely from within the first jaw or the second jaw for clamping and alignment; and The complaint alleges the beam portions are flat plates attached to a central web that engage the jaws from within, using a diagram of a "Closed channel" to illustrate the beam's position inside the jaws (Compl. p. 29). ¶158 col. 6:3-6
the pusher and the central web portion are coplanar with a channel defined in a tissue contacting surface of each of the first jaw and the second jaw when the beam moves distally. The complaint alleges the pusher and central web are coplanar with a jaw channel, again referencing the "Closed channel" diagram (Compl. p. 29). ¶147 col. 6:58-63
  • Identified Points of Contention:
    • Scope Question: Do the accused products possess two structurally and functionally distinct assemblies for "gross movement" and "fine movement" as claimed, or a single integrated mechanism? The definition of these terms will be central to the dispute.
    • Technical Question: Can Plaintiff prove the specific geometric limitations of claim 1, such as that a beam portion is "orthogonally attached" to the central web and that the pusher is "coplanar" with the web and a jaw channel? These precise spatial relationships are difficult to establish from marketing materials and will likely require expert analysis of the physical devices.

V. Key Claim Terms for Construction

For the ’650 Patent:

  • The Term: "beam configured to engage the first and second jaws... from within"
  • Context and Importance: This term is critical because it defines the structural relationship by which the claimed apparatus maintains alignment during stapling. Practitioners may focus on this term because the infringement analysis will depend heavily on whether the accused ECHELON "3-Point Gap Control" mechanism is considered to engage the jaws "from within."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent's summary describes the invention in functional terms as a system with a control handle that includes an actuator for "moving the jaws relative to one another" ('650 Patent, col. 2:12-14). This could support an interpretation where any internal component that achieves alignment satisfies the limitation, regardless of its precise placement.
    • Evidence for a Narrower Interpretation: The detailed description and figures show a specific I-beam member (70) that travels inside an "arcuate channel 90" defined within the opposing jaws ('650 Patent, Fig. 11; col. 5:58-63). This specific embodiment could be used to argue that "from within" requires the beam to be located inside a dedicated channel within the main body of the jaws.

For the ’892 Patent:

  • The Term: "first adjustment assembly configured for gross movement" and "second adjustment assembly ... configured for fine movement"
  • Context and Importance: The claim requires two separate assemblies with distinct functions. The viability of the infringement claim rests on whether the accused devices can be shown to have two such assemblies, rather than a single, multi-functional one.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not provide explicit definitions for "gross" or "fine." A party could argue that any initial, larger-scale closing of the jaws constitutes "gross" movement, while the final, pressure-applying clamping action constitutes "fine" movement, allowing two stages of a single mechanism to satisfy the claim.
    • Evidence for a Narrower Interpretation: The specification describes distinct structures for these functions: an "actuation cable 44 to facilitate gross approximation" and a separate "clamping member 60" driven by a gear system "to finely approximate the jaws" ('892 Patent, col. 5:1-3, 5:16-21). A party could argue that the terms are limited to these structurally separate embodiments, requiring two different mechanisms in the accused device.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendant induces infringement by providing customers with the Accused Products along with "instruction materials, training, and services" that instruct users on how to operate the devices in an infringing manner (Compl. ¶¶ 141, 171, 196). The complaint also alleges contributory infringement, stating the Accused Products are a material component not suitable for substantial non-infringing use (Compl. ¶¶ 142, 172, 197).
  • Willful Infringement: The complaint makes a detailed allegation of willful infringement, asserting that Defendant had pre-suit knowledge of all three asserted patents on specific dates. This knowledge is alleged to have come from a series of communications, including notice letters for the '650 Patent (Sept. 13, 2016) and '033 Patent (July 1, 2020), and an in-person presentation covering the '650 and '892 Patents (Dec. 3, 2019) (Compl. ¶¶ 117-119, 200-201). The complaint alleges that Defendant's infringement continued on an ongoing basis despite this knowledge (Compl. ¶ 201).

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

  • A central issue will be one of claim construction and scope: can the terms "gross movement" and "fine movement" from the '892 patent be read to cover different operational stages of a single mechanism in the accused devices, or do they require two structurally distinct assemblies? Similarly, the interpretation of the beam engaging the jaws "from within" ('650 patent) versus "below an outermost surface" ('033 patent) will be critical in determining the scope of each patent.
  • A key evidentiary question will be one of technical and geometric infringement: does the accused ECHELON stapler's "3-Point Gap Control" system meet the specific geometric limitations of the patents, such as the "orthogonally attached" and "coplanar" requirements of the '892 patent? The case will likely hinge on expert testimony dissecting the internal mechanics of the accused products to prove or disprove these precise spatial relationships.
  • A third major question will concern willfulness: given the complaint’s detailed allegations of pre-suit notice, including specific dates for letters and a presentation, the court will need to determine whether Defendant’s alleged continued infringement in the face of this knowledge was egregious enough to warrant enhanced damages under 35 U.S.C. § 284.