DCT

1:25-cv-00064

Rex Medical LP v. Ethicon Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:25-cv-00064, D. Del., 02/04/2025
  • Venue Allegations: Plaintiff alleges venue is proper based on the court’s personal jurisdiction over the Defendants, who are alleged to have minimum contacts with the State of Delaware.
  • Core Dispute: Plaintiff alleges that Defendant’s surgical staplers and tissue sealers infringe three patents related to apparatuses and methods for simultaneously cutting and sealing tissue during surgical resection.
  • Technical Context: The technology relates to minimally invasive surgical devices used for tissue resection, a critical function in widely performed procedures such as bariatric, thoracic, and colorectal surgeries.
  • Key Procedural History: The complaint notes that two of the asserted patents, U.S. Patent Nos. 9,439,650 and 10,136,892, were previously asserted against Intuitive Surgical in the District of Delaware, resulting in a jury verdict of infringement for one claim of the '650 Patent. Additionally, the complaint states that the patentability of certain claims of the '650 Patent was confirmed in an inter partes review proceeding. Plaintiff also alleges providing Defendant with notice of the asserted patents beginning in September 2016.

Case Timeline

Date Event
2001-01-31 '650, '892, and '033 Patents Priority Date
2016-09-13 U.S. Patent No. 9,439,650 Issued
2016-09-13 Plaintiff Alleges Providing Notice of '650 Patent to Defendant
2018-11-27 U.S. Patent No. 10,136,892 Issued
2019-12-03 Plaintiff Alleges Providing Notice of '892 Patent to Defendant
2020-06-09 U.S. Patent No. 10,675,033 Issued
2020-07-01 Plaintiff Alleges Providing Notice of '033 Patent to Defendant
2025-02-04 Complaint Filing Date

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

U.S. Patent No. 9,439,650 - “Apparatus and Method for Resectioning Gastro-Esophageal Tissue”

The Invention Explained

  • Problem Addressed: The patent’s background section describes prior endoscopic stapling devices as having a limited range of motion, complicating procedures that require precise positioning within a patient's body (’650 Patent, col. 1:36-51). The complaint further notes the general surgical need to simultaneously cut and seal tissue during resection to prevent leakage from remaining tissue (Compl. ¶22).
  • The Patented Solution: The invention is a surgical system that includes an operative head with a pair of opposed, movable jaws for clamping tissue (’650 Patent, Abstract). One jaw contains a stapling mechanism, and the other jaw provides an anvil surface to form the staples, enabling the device to staple and cut tissue in a single action (Compl. ¶25; ’650 Patent, col. 4:3-15). The device is operated by a control handle that remains outside the patient, facilitating its use in minimally invasive procedures (Compl. ¶25).
  • Technical Importance: The technology is described as enabling the efficient sealing of cut tissue during resection, a function particularly useful in laparoscopic, or minimally invasive, surgery (Compl. ¶24, ¶27).

Key Claims at a Glance

  • The complaint asserts claim 6, which depends from claim 5, which in turn depends from independent claim 4 (Compl. ¶73-76).
  • The essential elements of the asserted claim combination include:
    • An apparatus with a movable first jaw and second jaw for clamping tissue.
    • The first jaw has a staple carrying portion with slots, and the second jaw has an opposing anvil surface.
    • At least one of a gear or a cable is configured to move the jaws into alignment.
    • A staple pusher is configured to move staples from the staple carrying portion.
    • A beam is configured to engage the first and second jaws "one of entirely or substantially from therewithin" to maintain distance and alignment while tissue is stapled.
    • The beam comprises an upper portion, a lower portion, and a connecting web, with the upper and lower portions configured to cooperatively engage the jaws to align the staple slots with the anvil.
    • At least one of the beam's portions is configured to cause the staple pusher to move as the beam advances.

U.S. Patent No. 10,136,892 - “Apparatus and Method for Resectioning Gastro-Esophageal Tissue”

The Invention Explained

  • Problem Addressed: As with the ’650 Patent, the invention addresses the challenges of performing localized resections of tissue, such as gastro-esophageal lesions, with endoscopic devices that may have a limited range of motion (’892 Patent, col. 1:33-40; Compl. ¶¶21-23).
  • The Patented Solution: The patent describes a surgical apparatus with a head containing two movable jaws, a handle, and a connecting shaft (’892 Patent, Abstract). The apparatus features a "first adjustment assembly configured for gross movement" of the jaws and a "second adjustment assembly including a beam configured for fine movement" to maintain a fixed distance between the jaws during operation (’892 Patent, col. 7:60-63). The beam includes a central web with a cutting blade and is coupled to a pusher to fire staples as it moves distally (’892 Patent, col. 8:1-5).
  • Technical Importance: The described dual-adjustment assembly suggests a design focused on providing both broad and precise control over the positioning and clamping of tissue, which is critical for creating a reliable seal during resection (Compl. ¶27).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 5 (Compl. ¶97, ¶110).
  • Essential elements of independent claim 1 include:
    • A head with a movable first jaw and second jaw.
    • A "first adjustment assembly configured for gross movement" of the jaws.
    • A "second adjustment assembly including a beam configured for fine movement" that is coupled to a pusher and includes a central web, an upper portion, and a lower portion, with the web including a cutting blade.
    • A handle with actuators coupled to the head by a shaft.
    • At least one of the beam’s upper or lower portions is a "generally flat plate" configured to engage a jaw "entirely from within."
    • The pusher and the central web portion are "coplanar with a channel" defined in the jaws' tissue contacting surfaces as the beam moves distally.
  • Essential elements of independent claim 5 include:
    • A head portion with a movable first and second jaw.
    • A beam with an upper portion, lower portion, and a central web containing a cutting blade, configured to clamp and align the jaws "at least partially from within."
    • A pusher operatively coupled to the beam.
    • A control handle and a connecting shaft.
    • At least one of the beam's upper or lower portions is "orthogonally attached" to an end of the central web.

U.S. Patent No. 10,675,033 - “Apparatus and Method for Resectioning Gastro-Esophageal Tissue”

  • Technology Synopsis: This patent, part of the same family as the other asserted patents, is also directed to a surgical apparatus for resecting tissue (Compl. ¶¶25, 39). The invention described in the asserted claims includes an apparatus with two movable jaws, a beam with upper, lower, and central web portions, a staple pusher, and a "linear pusher" with a distal end "entirely and fixedly coupled to the beam" that is configured to move the beam and thereby trigger the staple pusher (’033 Patent, col. 8:5-12). Another asserted claim describes an apparatus with an "I-beam" configured to move along the jaws to clamp tissue and trigger sealing (’033 Patent, col. 10:1-21).
  • Asserted Claims: Independent claims 1 and 19 (Compl. ¶127, ¶137).
  • Accused Features: The complaint alleges that the "Accused Stapler Products" infringe claim 1 by incorporating the claimed two-pusher system (linear pusher and staple pusher) (Compl. ¶135), while the "Accused Sealer Products" infringe claim 19 by incorporating the claimed I-beam structure that clamps and seals tissue (Compl. ¶141).

III. The Accused Instrumentality

Product Identification

The complaint identifies two classes of accused products:

  1. "Accused Stapler Products," which include the ECHELON+ Powered Stapler, ECHELON FLEX Powered Vascular Stapler, ECHELON FLEX ENDOPATH Stapler, and associated Reload Cartridges (Compl. ¶41).
  2. "Accused Sealer Products," which include the ENSEAL G2 Articulating, Curved, and Straight Tissue Sealers (Compl. ¶58).

Functionality and Market Context

The accused products are described as surgical instruments used to cut and simultaneously staple or seal tissue in various minimally invasive procedures, including bariatric, thoracic, and colorectal surgeries (Compl. ¶¶42-45). The complaint alleges these products incorporate key features of the patented technology, such as a pair of movable jaws for clamping tissue and a beam mechanism that travels between the jaws to maintain alignment while driving a cutting blade and either staples or sealing energy (Compl. ¶¶79-88, 113-118). The complaint points to the high volume of such surgeries performed annually in the U.S. as evidence of the products' commercial significance (Compl. ¶¶43-45). A marketing diagram illustrates what is alleged to be the accused product's beam, described as a "3-Point Gap Control" mechanism, which allegedly maintains alignment as a knife travels from the proximal to the distal end (Compl. ¶85, p. 18).

IV. Analysis of Infringement Allegations

U.S. Patent No. 9,439,650 Infringement Allegations

Claim Element (from Independent Claim 4, as incorporated into asserted Claim 6) Alleged Infringing Functionality Complaint Citation Patent Citation
a first jaw and a second jaw, at least one... being movable... from a first configuration... to receive tissue and a second configuration... to hold tissue therebetween for stapling The accused staplers have two jaws, at least one of which is movable between an open position to receive tissue and a closed position to clamp tissue for stapling. The complaint provides a visual from a product video showing this movement. ¶79 col. 4:5-15
a staple carrying portion of the first jaw defining slots through which staples are configured to pass The accused staplers' "Reload channel" is alleged to be the staple carrying portion, as it holds staples and has slots for them to pass through. ¶80 col. 4:5-7
an anvil surface defined on the second jaw opposing the first jaw The accused staplers have an anvil surface on the second jaw to form the staples passed from the first jaw. ¶81 col. 6:49-54
a beam configured to engage the first and second jaws from within the first and second jaws while tissue is stapled The accused staplers allegedly have a beam ("3-point gap control mechanism") that engages the jaws from within to maintain distance and alignment during firing. ¶84 col. 6:28-36
From Claim 6: the beam comprises an upper portion and a lower portion and a web coupled between... the upper portion and the lower portion configured to cooperatively engage the first jaw and the second jaw to align the slots with a staple forming portion The accused products' beam is alleged to have upper and lower portions and a connecting web that engage the two jaws to align the staple slots with the anvil surface. ¶86, ¶88 col. 5:53-62
From Claim 6: at least one of the lower portion or the upper portion configured to cause the staple pusher to move a staple as the beam moves At least one of the accused beam's portions is alleged to cause the staple pusher to move a staple as the beam advances from a proximal to a distal location. ¶87 col. 6:10-24

U.S. Patent No. 10,136,892 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... being movable The accused staplers have a head with at least one movable jaw. ¶101 col. 4:4-8
a first adjustment assembly configured for gross movement of the first jaw or the second jaw The complaint does not provide sufficient detail for analysis of this specific element, though it alleges all limitations are met. ¶99 col. 7:59-60
a second adjustment assembly including a beam configured for fine movement... the beam... 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 staplers allegedly have a beam with a central web, upper and lower portions, and a cutting blade that provides for fine movement and maintains a fixed distance. ¶105 col. 8:1-5
at least one of the upper beam portion and the lower beam portion... 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 The accused staplers' beam portions are alleged to be generally flat plates that engage the jaws entirely from within for clamping and alignment. An animated diagram is provided to show this engagement. ¶109 col. 8:10-16
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 does not provide sufficient detail for analysis of this specific element, though it alleges all limitations are met. ¶99 col. 8:17-22

Identified Points of Contention

  • Scope Questions: A primary issue may be whether the accused products’ internal mechanisms, described in marketing terms like a "3-Point Gap Control" system (Compl. ¶85), meet the specific structural and functional requirements of the claimed "beam." The interpretation of relational terms like "from within" (’650 Patent) and "entirely from within" (’892 Patent) will be critical to determining if the accused beam's engagement with the jaws falls within the claim scope.
  • Technical Questions: The complaint alleges infringement of highly specific mechanical arrangements, such as the "first adjustment assembly for gross movement" and "second... for fine movement" of the ’892 Patent. A key question for the court will be what technical evidence supports the existence of these distinct assemblies in the accused products, as the complaint primarily relies on high-level product animations and diagrams that may not depict such details.

V. Key Claim Terms for Construction

  • The Term: "beam"

  • Context and Importance: This term is foundational to the independent claims of all three asserted patents. Its claimed structure (e.g., upper/lower portions, web) and functions (engaging jaws, maintaining alignment, driving a staple pusher) are central to the plaintiff's infringement theory against both the stapler and sealer products. Practitioners may focus on this term because its construction will determine whether the accused products' "3-point gap control" or "I-BLADE" mechanisms are structurally and functionally equivalent to the claimed invention.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the element functionally as a "translating clamping member" that moves to approximate the jaws, suggesting the term may not be limited to a single rigid structure (’650 Patent, col. 4:65-67).
    • Evidence for a Narrower Interpretation: The patents consistently illustrate this element as an "I-beam member" with a specific geometry (e.g., ’650 Patent, Figs. 13-15, item 70). A defendant may argue that the term "beam" should be construed as being limited to this disclosed I-beam structure and its equivalents.

  • The Term: "engage the first jaw or the second jaw entirely from within" (’892 Patent, Claim 1)

  • Context and Importance: This limitation defines a precise spatial relationship between the beam and the jaws, which is a key part of the infringement allegation against the Accused Stapler Products (Compl. ¶109). The viability of the infringement case for this claim may depend on whether the accused mechanism satisfies this geometric constraint.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification does not provide an explicit definition for "entirely from within." A plaintiff may argue the term simply requires the beam's jaw-engaging surfaces to be located between the outermost boundaries of the jaw structures, not that the beam must be fully enclosed.
    • Evidence for a Narrower Interpretation: The cross-sectional view in Figure 15 of the ’892 Patent depicts the I-beam member (70) situated within channels of the staple carrying portion (40) and staple forming portion (50). A defendant may argue this figure defines the claimed relationship, requiring the beam to be nested or contained within the jaw structures during engagement.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that by advertising, distributing, and providing instructional materials and training for the accused products, Defendant has induced its customers to infringe (Compl. ¶91-92, ¶121-122, ¶146-147). It further alleges contributory infringement on the basis that the accused products are material components especially made for an infringing use and are not staple articles of commerce (Compl. ¶93, ¶123, ¶148).
  • Willful Infringement: The willfulness allegation is based on alleged pre-suit knowledge of the asserted patents. The complaint cites specific dates on which Plaintiff allegedly provided Defendant with notice of each patent: September 13, 2016 for the ’650 Patent; December 3, 2019 for the ’892 Patent; and July 1, 2020 for the ’033 Patent (Compl. ¶¶67-69, 151). The complaint alleges that Defendant's infringement was willful because it continued despite this alleged knowledge (Compl. ¶152).

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

  • A core issue will be one of claim scope: can the term "beam," which is consistently depicted in the patents as a specific I-beam structure, be construed broadly enough to read on the accused products' "3-Point Gap Control" and "I-BLADE" mechanisms? The outcome of this question, particularly regarding the spatial limitations "from within" and "entirely from within," will be central to the infringement analysis.
  • A key evidentiary question will be one of structural correspondence: does the internal mechanical operation of the accused ECHELON and ENSEAL products map onto the granular, multi-part assemblies recited in the claims, such as the distinct "first adjustment assembly for gross movement" and "second adjustment assembly... for fine movement" of the '892 Patent? The complaint's current reliance on high-level marketing visuals raises the question of what factual evidence will be required to prove these detailed infringement allegations.
  • Given the history of prior litigation and an inter partes review involving the '650 Patent, a significant legal question will be the impact of prior proceedings: how might claim constructions adopted in the previous litigation or arguments made by the patent owner during the IPR proceeding influence the court's analysis and potentially create estoppel issues that limit the scope of the claims asserted in this case?