DCT

1:19-cv-00005

Rex Medical LP v. Intuitive Surgical Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-00005, D. Del., 03/27/2019
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because each Defendant is organized under the laws of Delaware and is therefore a resident of the district.
  • Core Dispute: Plaintiff alleges that Defendant’s da Vinci Surgical Systems, when used with the SureForm 60 Stapler, infringe two patents related to surgical devices for simultaneously stapling and cutting tissue.
  • Technical Context: The technology relates to minimally invasive surgical staplers used in procedures like tissue resection, where tissue is both cut and sealed, a critical function in modern endosurgery.
  • Key Procedural History: The complaint asserts claims from U.S. Patent No. 9,439,650 that subsequently survived an inter partes review (IPR) proceeding (IPR2020-00152), which was initiated after the filing of this complaint. A certificate issued on May 10, 2022 confirmed the patentability of asserted claims 6, 19, and 21, while cancelling other claims not asserted in this litigation. This post-complaint development may strengthen the '650 patent's presumption of validity regarding the art considered in the IPR.

Case Timeline

Date Event
2001-01-31 Priority Date for '650 and '892 Patents ('469 Provisional App.)
2016-09-13 U.S. Patent No. 9,439,650 Issued
2018-01-01 Accused SureForm 60 Stapler First Introduced (approx. date)
2018-11-27 U.S. Patent No. 10,136,892 Issued
2019-03-27 First Amended Complaint Filed
2019-11-19 IPR Petition Filed Against '650 Patent
2022-05-10 IPR Certificate Issued for '650 Patent

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 (’650 Patent)

The Invention Explained

  • Problem Addressed: The patent addresses the challenge in surgical resection of having to both cut targeted tissue and simultaneously seal the remaining tissue to ensure it "is not left open and exposed" (Compl. ¶23). The background notes that prior endoscopic staplers had a "limited range of motion" ('650 Patent, col. 1:41-44).
  • The Patented Solution: The invention is a surgical stapling apparatus featuring an operative head with two opposable jaws, one holding staples and the other serving as a forming anvil (Compl. ¶26). A key aspect is an internal "I-beam member" that moves through the jaws to fire staples and, in some embodiments, simultaneously cut tissue, ensuring the jaws remain properly aligned during the procedure ('650 Patent, col. 6:30-49). This mechanism is controlled by a handle that remains outside the patient’s body ('650 Patent, Abstract).
  • Technical Importance: The technology aimed to provide a more effective and reliable tool for performing tissue resection and anastomosis in a minimally invasive (e.g., laparoscopic) manner (Compl. ¶25, ¶27).

Key Claims at a Glance

  • The complaint asserts dependent claims 6, 19, and 21. These depend on independent claims 4 and 13.
  • Independent Claim 4 requires:
    • A first jaw and a movable second jaw that clamp tissue.
    • A staple carrying portion on the first jaw with slots.
    • An anvil surface on the second jaw.
    • A gear or cable to move the jaws into alignment.
    • A staple pusher.
    • A "beam configured to engage the first and second jaws from within" to maintain distance and alignment during stapling.
  • Independent Claim 13 requires:
    • A head portion with a first and second jaw for receiving and stapling tissue.
    • The first jaw having a cavity for staples and slots for them to pass through.
    • The second jaw having a staple-forming surface.
    • A "beam" with opposite end portions connected by a web, configured to clamp and align the jaws "from therewithin" as it moves distally.
    • A control handle and a shaft coupling the handle to the head.
  • The complaint reserves the right to assert additional claims (Compl. ¶47).

U.S. Patent No. 10,136,892, “Apparatus and Method for Resectioning Gastro-Esophageal Tissue,” issued November 27, 2018 (’892 Patent)

The Invention Explained

  • Problem Addressed: Like its parent, the '892 Patent concerns the need for improved endoscopic devices for localized tissue resections ('892 Patent, col. 1:28-31).
  • The Patented Solution: This invention refines the surgical stapler concept by detailing distinct assemblies for "gross movement" and "fine movement" of the jaws ('892 Patent, col. 7:60-62). It claims a specific beam structure, including a central web with a cutting blade and upper/lower portions that are "generally flat plate[s] orthogonally attached" to the web. This beam is designed to engage the jaws "entirely from within" for clamping and alignment while it moves distally to fire staples and cut tissue ('892 Patent, Claim 1).
  • Technical Importance: The invention describes a more structurally defined mechanism intended to enhance the precision of clamping, alignment, and cutting during complex endoscopic surgeries.

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 5.
  • Independent Claim 1 requires:
    • A head with movable jaws, a stapling assembly, and an anvil surface.
    • A "first adjustment assembly" for gross jaw movement.
    • A "second adjustment assembly" with a beam for fine movement.
    • The beam must have an upper/lower portion, a central web with a cutting blade, and be coupled to a pusher.
    • A handle and a shaft.
    • A geometric limitation: at least one beam portion must be a "generally flat plate orthogonally attached" to the web.
    • A functional limitation: the pusher and web must be "coplanar with a channel" in the jaws.
  • Independent Claim 5 requires:
    • A head portion with movable jaws for sealing tissue.
    • A beam with upper/lower portions connected by a web, with a cutting blade on its leading edge.
    • The beam clamps and aligns the jaws "at least partially from within."
    • A pusher coupled to the beam.
    • A control handle and a shaft.
    • A geometric limitation: at least one beam portion is "orthogonally attached" to the web and the pusher is "coplanar with the central web portion and the channel."

III. The Accused Instrumentality

Product Identification

  • The "da Vinci Surgical System Xi" and "da Vinci Surgical System X" when used with the "SureForm 60 Stapler" and "SureForm 60 reloads" (collectively, the "Accused Product") (Compl. ¶37, ¶40, ¶45).

Functionality and Market Context

  • The Accused Product is a robotic surgical stapler used for tissue resection, transection, and the creation of anastomoses (Compl. ¶43). It consists of an instrument with two jaws (an anvil and a staple-carrying "reload channel"), a shaft, and an instrument housing (Compl. ¶44, ¶55-56). A structure identified in the user manual as an "I-beam" is used to cut tissue and maintain jaw alignment during firing (Compl. p.14, Fig. 1.3). The stapler is controlled by the surgeon via foot pedals at a console, which actuate the clamping and firing sequences (Compl. p.23, Fig. 2.9). The complaint alleges the SureForm 60 Stapler was introduced in 2018 (Compl. ¶41).

IV. Analysis of Infringement Allegations

’650 Patent Infringement Allegations

The complaint alleges infringement of claims 6, 19, and 21. The table below summarizes the allegations for claim 6, which depends from independent claim 4.

Claim Element (from Independent Claim 4 and Dependent Claims 5 & 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 ... for stapling The Accused Product has two jaws, an anvil and a channel, that move from an open position to a clamped position to hold tissue. A diagram from the user manual shows the jaws opening via a Manual Release Knob (Compl. p.23, Fig 2.1). ¶54 col. 4:5-15
a staple carrying portion of the first jaw defining slots through which staples are configured to pass The Accused Product’s "Reload channel" holds staples and has slots for the staples to pass through. An animation still depicts the staples and slots within the channel jaw (Compl. p.11). ¶55 col. 5:5-7
an anvil surface defined on the second jaw opposing the first jaw The second jaw of the Accused Product is an "anvil" with a surface that forms the staples. A product diagram explicitly labels the anvil (Compl. p.12, Fig 1.2). ¶56 col. 5:8-9
a beam configured to engage the first and second jaws ... from therewithin to maintain the second distance and the alignment The Accused Product uses an "I-beam" that engages the jaws from within to maintain alignment while staples are fired. A diagram from the user manual shows the "I-Beam Home Position" within a channel on the jaw (Compl. p.14, Fig 1.3). ¶59, ¶60 col. 8:31-35
[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 on the anvil Surface The Accused Product’s beam has an upper portion, a lower portion, and a connecting web that engage both jaws to ensure alignment. An annotated product animation highlights these separate portions of the beam (Compl. p.16). ¶61, ¶63 col. 6:4-12

’892 Patent Infringement Allegations

The complaint alleges infringement of claims 1 and 5. The table below summarizes the allegations for independent claim 1.

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 ... from a first configuration ... to a second configuration The Accused Product has a head with two movable jaws. An illustration shows the jaws moving from an open to a closed configuration to grasp tissue (Compl. p.29). ¶88 col. 7:46-53
a first adjustment assembly configured for gross movement of the first jaw or the second jaw The Accused Product has an assembly for gross movement of the jaws, such as opening them to receive tissue. ¶91 col. 4:63-65
a second adjustment assembly including a beam configured for fine movement ... to maintain a fixed distance ... the beam ... including a central web portion including a cutting blade which is generally more distal than at least one of a trailing edge of the upper beam portion... The Accused Product has a beam for fine movement that includes a cutting blade. An animation still shows formed staples in advance of the knife, indicating the cutting blade is distal to the portion of the beam that has already passed (Compl. p.32). ¶92, ¶93 col. 8:1-5
a handle having one or more actuators configured to move at least one of the first jaw ... and to actuate the stapling assembly The stapler is actuated by surgeon foot pedals ("Blue: Clamp" and "Yellow: Fire") which function as the handle's actuators to clamp tissue and fire the stapler (Compl. p.34, Fig 2.9). ¶95 col. 2:10-14
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 On information and belief, the Accused Product's beam has at least one portion that is a generally flat plate, orthogonally attached to the web, and engages the jaws from within. The complaint provides an animation still of the beam moving within the jaws to support this allegation (Compl. p.35). ¶97 col. 8:11-17

Identified Points of Contention

  • Scope Questions: Both patents were developed in the context of flexible endoscopic staplers. A potential question is whether claim terms rooted in that context, such as "control handle," can be read to cover the distributed control system (console, foot pedals) of a robotic surgical platform like the da Vinci system.
  • Technical Questions: The infringement allegations rely heavily on marketing animations and user manual diagrams. A central question will be whether the actual physical construction of the Accused Product’s "I-beam" meets the specific geometric limitations of the '892 patent, such as being a "generally flat plate orthogonally attached to an end of the central web portion." The complaint asserts this on "information and belief," suggesting it may be a point of discovery and dispute.

V. Key Claim Terms for Construction

  • Term: "beam configured to engage the first and second jaws ... from within" ('650 Patent, Claim 4) / "from therewithin" ('650 Patent, Claim 13)

    • Context and Importance: This term is central to the claimed mechanism for maintaining jaw alignment during firing. The infringement case for the '650 patent depends on proving the SureForm stapler's I-beam functions "from within" the jaws, a term that is not explicitly defined.
    • Intrinsic Evidence for a Broader Interpretation: The specification describes the function of the beam as ensuring the jaws are "brought into cooperative alignment, tightly clamping the tissue therebetween" ('650 Patent, col. 5:22-24), which could support an interpretation focused on the function of alignment rather than a specific location.
    • Intrinsic Evidence for a Narrower Interpretation: Figures 13-15 of the patent depict a specific "I-beam member" (70) that slides within corresponding channels (90) inside the jaws. A defendant may argue these embodiments limit the term "from within" to mean residing inside such dedicated internal channels.

  • Term: "a generally flat plate orthogonally attached" ('892 Patent, Claim 1)

    • Context and Importance: This is a precise geometric limitation that distinguishes the '892 patent. Infringement of Claim 1 will likely turn on a direct factual comparison of the accused I-beam's geometry to this language. Practitioners may focus on this term because its specificity provides a clear potential basis for a non-infringement argument.
    • Intrinsic Evidence for a Broader Interpretation: The use of the word "generally" before "flat plate" suggests that the claim may tolerate minor deviations from perfect flatness or perfect 90-degree angles, allowing for manufacturing tolerances or slight curvatures.
    • Intrinsic Evidence for a Narrower Interpretation: The figures, such as Figure 14, depict a distinct I-beam structure where the upper and lower portions (82a, 82b) are shown as clearly flat and attached at right angles to the central web (84). This could be used to argue against any significant deviation from a classic "I" shape.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement based on Defendant’s actions of "advertising and distributing the Accused Product and providing instruction materials, training, and services" that allegedly instruct users on how to perform the infringing actions (Compl. ¶80, ¶110). Contributory infringement is alleged on the basis that the Accused Product is a "material component" especially adapted for an infringing use and is "not a staple article of commerce" (Compl. ¶81, ¶111).
  • Willful Infringement: The complaint includes a prayer for relief seeking an adjudication that infringement has been willful and an award of treble damages (Compl. p. 45, C). The body of the complaint, however, does not plead specific facts to support pre-suit knowledge of the patents, so the willfulness claim may depend on conduct after the complaint was filed.

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

  1. A core issue will be one of structural and geometric interpretation: Can the specific physical design of the accused SureForm stapler’s I-beam be proven to meet the precise language of the patents? This will turn on the construction of terms like "engage ... from within" ('650 patent) and, most critically, whether the beam constitutes a "generally flat plate orthogonally attached" to its central web ('892 patent).

  2. A key legal question will be the effect of the post-complaint IPR: While the asserted claims of the '650 patent survived review, the prosecution history from that proceeding could have narrowed their effective scope. The case will likely involve disputes over whether statements made or prior art considered during the IPR limit the plaintiff's infringement theories now.

  3. A key evidentiary question will be one of technical proof: Given the complaint's reliance on marketing animations and high-level manual diagrams, can the plaintiff produce sufficient factual evidence from the actual accused device to demonstrate that its internal components—particularly the beam-jaw interface—operate in the specific manner required by the claim limitations?