DCT

1:16-cv-12556

Ethicon Endo Surgery Inc v. Covidien LP

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:16-cv-12556, D. Mass., 12/19/2016
  • Venue Allegations: Plaintiff alleges venue is proper because Defendants regularly conduct business in the District of Massachusetts and have consented to venue there in prior actions.
  • Core Dispute: Plaintiff seeks a declaratory judgment that its ENSEAL® X1 Large Jaw Tissue Sealer product does not infringe five U.S. patents owned or licensed by Defendant related to electrosurgical instruments for sealing and transecting tissue.
  • Technical Context: The dispute concerns advanced energy devices used in surgery to simultaneously seal and cut blood vessels and tissue, a technology critical for minimizing bleeding and procedure time in both open and minimally invasive operations.
  • Key Procedural History: The complaint details a long history of patent litigation between the parties. It asserts that this action arises from a dispute governed by a 1999 Settlement Agreement that requires pre-litigation mediation. Plaintiff states that after it initiated mediation to confirm its product did not infringe, Defendant informed Plaintiff of its view that the product infringes one or more claims of each of the patents-in-suit, leading to an impasse. The complaint also notes that Plaintiff previously filed two unsuccessful petitions for inter partes review against one of the patents-in-suit (U.S. Patent No. 8,241,284) at the Patent Trial and Appeal Board.

Case Timeline

Date Event
1998-10-23 Earliest Priority Date for ’735 Patent
2001-04-06 Earliest Priority Date for ’587 Patent
2001-04-06 Earliest Priority Date for ’253 Patent
2001-04-06 Earliest Priority Date for ’284 Patent
2003-07-01 ’735 Patent Issued
2006-10-10 ’587 Patent Issued
2006-11-09 Earliest Priority Date for ’748 Patent
2009-01-06 ’253 Patent Issued
2011-12-06 ’748 Patent Issued
2012-08-14 ’284 Patent Issued
2015-05-27 Ethicon files first inter partes review petition against the ’284 Patent
2015-12-17 PTAB denies institution of first inter partes review of the ’284 Patent
2016-04-25 Ethicon files second inter partes review petition against the ’284 Patent
2016-09-09 FDA provides premarket approval for Plaintiff’s ENSEAL X1 device
2016-10-24 PTAB denies institution of second inter partes review of the ’284 Patent
2016-12-19 Complaint for Declaratory Judgment Filed

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

U.S. Patent No. 6,585,735 - "Endoscopic Bipolar Electrosurgical Forceps," Issued July 1, 2003

The Invention Explained

  • Problem Addressed: The patent addresses the difficulty of effectively sealing larger blood vessels during endoscopic surgery. It explains that achieving a reliable seal requires precise control over both the clamping pressure applied to the vessel and the gap distance between the instrument's two electrode jaws. Existing instruments allegedly struggled to provide the high closure forces needed for larger vessels within the compact design constraints of endoscopic tools without risking mechanical failure. (’735 Patent, col. 2:21-36, col. 3:6-24).
  • The Patented Solution: The invention is a bipolar forceps designed to solve the gap-control and force-application problems. Its key feature is the inclusion of "at least one stop member" on the sealing surface of a jaw member, which physically controls the minimum distance between the jaws when clamped on tissue. This feature is intended to ensure an optimal gap for energy delivery. The patent also describes a cam-follower mechanical linkage and yoke system to translate a user's handle movement into a high-force, linear clamping motion at the jaws, addressing the need for greater closure force. (’735 Patent, Abstract; col. 4:3-12, col. 9:50-64).
  • Technical Importance: The claimed combination of a force-multiplying linkage and a physical stop member provided a mechanical design intended to create consistent and reliable vessel seals, a critical factor for the safety and efficacy of minimally invasive surgical procedures. (Compl. ¶24; ’735 Patent, col. 2:37-47).

Key Claims at a Glance

The complaint asserts non-infringement of independent claims 1 and 9.

  • Claim 1 Elements:
    • First and second jaw members pivotally attached in opposing relation.
    • A drive rod assembly for connecting the jaw members to a source of bipolar electrical energy.
    • A handle attached to the drive rod assembly for imparting movement to the jaw members.
    • At least one stop member attached to a tissue sealing surface of one of the jaw members for controlling the distance between the opposing sealing surfaces.
  • Claim 9 Elements:
    • Claim 9 is similar to claim 1, but further specifies that the stop member is for "creating a gap distance of about 0.001 to about 0.006 inches" between the sealing surfaces.

U.S. Patent No. 7,118,587 - "Vessel Sealer and Divider," Issued October 10, 2006

The Invention Explained

  • Problem Addressed: The patent’s background section identifies two problems in electrosurgery. First, achieving a consistent and effective tissue seal requires applying a uniform pressure, which is difficult to control with simple plier-like handle mechanisms. Second, after sealing a vessel, the surgeon must typically withdraw the sealing instrument and insert a separate cutting instrument, a process that is time-consuming and risks misaligning the cut relative to the seal. (’587 Patent, col. 1:47 - col. 3:52).
  • The Patented Solution: The invention proposes a surgical instrument with a handle assembly that incorporates a "four-bar mechanical linkage." This specific linkage, which includes two handles, a link, and a rotating cam-like piston, is designed to generate a high mechanical advantage, thereby creating a large and uniform closure force at the jaw members. The instrument also integrates a knife assembly that can be actuated independently to divide the tissue along the seal line, solving the instrument-swapping problem. (’587 Patent, Abstract; col. 4:15-25).
  • Technical Importance: The invention’s use of a four-bar linkage offered a specific mechanical solution for generating high, reproducible clamping forces needed for large vessel sealing, while the integrated cutting mechanism aimed to improve surgical workflow and precision. (Compl. ¶24; ’587 Patent, col. 3:53-57).

Key Claims at a Glance

The complaint asserts non-infringement of independent claims 1 and 10.

  • Claim 1 Elements:
    • A housing with a shaft and opposing first and second jaw members.
    • A drive rod assembly to impart movement to the jaw members.
    • A handle assembly attached to the housing to actuate the drive rod, which includes a "four-bar mechanical linkage" further defined as comprising "two handles, a link and a rotating cam-like piston."
  • Claim 10 Elements:
    • Claim 10 is similar to claim 1, but specifies that the "four-bar mechanical linkage" and its components "cooperate with a spring to impart a uniform closure pressure against tissue grasped between the jaw members."

U.S. Patent No. 7,473,253 - "Vessel Sealer and Divider with Non-Conductive Stop Members," Issued January 6, 2009

  • Technology Synopsis: This patent relates to an endoscopic bipolar forceps that uses "at least one non-conductive and spaced-apart stop member" located on an inner surface of a jaw member. The purpose of the stop member is to control the gap distance between the jaws to ensure that the distance is "substantially uniform along the length of the jaw members" when tissue is clamped. (Compl. ¶¶74-75; ’253 Patent, Abstract).
  • Asserted Claims: Independent claims 1 and 6. (Compl. ¶¶74-75).
  • Accused Features: The complaint alleges that the ENSEAL X1 product does not have jaw members that are "independently movable with respect to the elongated shaft" or a "non-conductive stop member" that controls the distance as claimed. (Compl. ¶¶74-75).

U.S. Patent No. 8,070,748 - "Vessel Sealer and Divider for Large Tissue Structures," Issued December 6, 2011

  • Technology Synopsis: This patent describes the mechanical arrangement of the handle and knife actuator in an electrosurgical device. The claims focus on specific configurations, such as a "movable handle being rotatable about a pivot pin" to move the jaws, and a "finger actuator" with "two generally u-shaped flanges" that rotate to translate a knife through an aperture in the pivot. (Compl. ¶¶81-82; ’748 Patent, Abstract).
  • Asserted Claims: Independent claims 1 and 8. (Compl. ¶¶81-82).
  • Accused Features: The complaint alleges that the ENSEAL X1 product does not use the claimed handle or finger actuator mechanisms for moving the jaws and actuating the knife. (Compl. ¶¶81-82).

U.S. Patent No. 8,241,284 - "Vessel Sealer and Divider with Non-Conducive Stop Members," Issued August 14, 2012

  • Technology Synopsis: This patent, like the ’253 patent, focuses on the use of non-conductive stop members to control the gap between the instrument's jaws. The claims require a "plurality of non-conductive stop members" that are "disposed along the same plane on the seal surface" and are configured to "maintain a uniform distance between the jaw members along the length thereof." (Compl. ¶¶88-89; ’284 Patent, Abstract).
  • Asserted Claims: Independent claims 1 and 12. (Compl. ¶¶88-89).
  • Accused Features: The complaint alleges that the ENSEAL X1 does not have the plurality of non-conductive stop members configured in the manner required by the claims. (Compl. ¶¶88-89).

III. The Accused Instrumentality

  • Product Identification: The accused product is Plaintiff's ENSEAL® X1 Large Jaw Tissue Sealer ("ENSEAL X1"). (Compl. ¶2).
  • Functionality and Market Context: The ENSEAL X1 is described as a "single-patient-use electrosurgical instrument for sealing and transecting vessels" that utilizes advanced bipolar energy. (Compl. ¶¶2, 27). Plaintiff developed, manufactured, and has used the product in the United States and received FDA premarket approval for it on September 9, 2016. (Compl. ¶¶28-29). The complaint states that Plaintiff is preparing for a commercial launch of the product and that the parties are "direct competitors in the advanced energy surgical market." (Compl. ¶¶24, 29). The complaint does not provide specific technical details regarding the internal mechanics or operation of the ENSEAL X1.
  • Visual Evidence: No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint seeks a declaratory judgment of non-infringement. For each patent, it identifies specific claim limitations that the ENSEAL X1 allegedly does not satisfy, but it does not describe the corresponding structure or functionality of the ENSEAL X1 itself.

  • ’735 Patent Infringement Allegations
Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
"first and second jaw members pivotally attached in opposing relation relative to one another;" The complaint does not describe the ENSEAL X1's jaw attachment mechanism but alleges this limitation is not met. ¶60 col. 5:10-15
"a drive rod assembly adapted for connecting said jaw members to a source of electrical energy..." The complaint does not describe the ENSEAL X1's drive assembly but alleges this limitation is not met. ¶60 col. 5:1-3
"a handle attached to said drive rod assembly for imparting movement of said first and second jaw members..." The complaint does not describe the ENSEAL X1's handle mechanism but alleges this limitation is not met. ¶60 col. 5:26-31
"at least one stop member attached to at least one of said tissue sealing surfaces... for controlling the distance between opposing sealing surfaces..." The complaint does not describe the ENSEAL X1's gap control mechanism but alleges this limitation is not met. ¶60 col. 9:50-58

  • Identified Points of Contention:

    • Evidentiary Questions: The complaint makes conclusory allegations of non-infringement for each listed element of claim 1 without providing any supporting technical details about the ENSEAL X1. The central issue will be what evidence Plaintiff provides to demonstrate that the ENSEAL X1's jaw attachment, drive assembly, handle, and gap-control mechanism are structurally and functionally different from those required by the claim.
    • Scope Questions: The dispute may turn on the construction of "pivotally attached" and "stop member." For example, a key question for the court could be whether an integral feature of a jaw surface that limits closure can be considered a "stop member attached to" that surface, or if the term requires a separate component.

  • ’587 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
"a drive rod assembly which imparts movement of the jaw members between the first and second positions," The complaint does not describe the ENSEAL X1's drive assembly but alleges this limitation is not met. ¶67 col. 4:6-9
"a handle assembly... including a four-bar mechanical linkage... said four-bar mechanical linkage including two handles, a link and a rotating cam-like piston..." The complaint does not describe the ENSEAL X1's handle assembly but alleges this limitation is not met. ¶67 col. 8:25-33
  • Identified Points of Contention:
    • Technical Questions: The primary point of contention will likely be a direct comparison of the ENSEAL X1's handle mechanism against the very specific "four-bar mechanical linkage" structure recited in claim 1. The claim not only requires the linkage but also specifies its constituent parts ("two handles, a link and a rotating cam-like piston").
    • Scope Questions: A central question for the court will be whether the term "four-bar mechanical linkage" is limited to the specific embodiment described and claimed, or if it could be construed more broadly. The patent's explicit enumeration of the linkage's components may support a narrower interpretation.

V. Key Claim Terms for Construction

  • Term from the ’735 Patent: "at least one stop member attached to at least one of said tissue sealing surfaces"

    • Context and Importance: The "stop member" is the central feature claimed to solve the technical problem of maintaining a precise gap between the jaws. The non-infringement defense for this patent may depend on showing that the ENSEAL X1 either lacks any such feature or that its gap-control mechanism is not a "stop member" that is "attached to" the sealing surface as claimed.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim language uses the general term "stop member" and requires it to perform the function of "controlling the distance." (cl. 1). A party might argue this language could cover any physical impediment that serves this purpose, whether it is a discrete component or an integral feature.
      • Evidence for a Narrower Interpretation: The specification describes specific embodiments, such as stop member 139 and stake 119, which are distinct components. (’735 Patent, col. 9:50-64, col. 7:31-38). The claim requirement that the member be "attached to" the surface could be argued to exclude features that are integrally formed as part of the surface itself.

  • Term from the ’587 Patent: "a four-bar mechanical linkage...including two handles, a link and a rotating cam-like piston"

    • Context and Importance: This term defines the core mechanical novelty of the handle assembly. Plaintiff's non-infringement position likely relies on a structural difference between its handle mechanism and this specific, multi-component linkage.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: A party might argue that minor deviations from the described "cam-like piston" or "link" should not escape infringement if the overall structure operates as a four-bar linkage to achieve the same result.
      • Evidence for a Narrower Interpretation: The claim itself explicitly defines the "four-bar mechanical linkage" by listing its required sub-components. (’587 Patent, cl. 1). The specification, including Figure 13, provides a detailed depiction of this exact structure. This intrinsic evidence provides a strong basis for an argument that the claim is limited to a linkage containing these specific enumerated parts.

VI. Other Allegations

  • Indirect Infringement: The complaint seeks a judicial declaration that Plaintiff has not infringed and is not infringing "either directly, indirect, or otherwise any claim of the '735, '587, '253, '748, and '284 patents." (Compl., Prayer for Relief, ¶A). It does not contain factual allegations concerning indirect infringement but rather a denial thereof.

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

  1. Evidentiary Sufficiency: The complaint makes bare allegations of non-infringement without providing any technical description of the accused ENSEAL X1 product. A central question for the case will be what evidence Plaintiff will introduce to substantiate its claims of structural and functional difference, and whether that evidence is sufficient to overcome Defendant's infringement contentions.
  2. Definitional Scope: The dispute will likely focus on the construction of key mechanical terms. A core issue will be one of structural identity: does the handle mechanism of the ENSEAL X1 meet the specific, multi-part definition of a "four-bar mechanical linkage" as recited in the ’587 patent, or is it a fundamentally different design?
  3. Functional Interpretation: For the patents concerning "stop members" ('735, '253, '284), a key question will be one of functional and structural equivalence: does the ENSEAL X1's method for controlling jaw spacing rely on a structure that can be defined as a "stop member attached to" a jaw surface, or does it achieve this function in a way that falls outside the patent's claims?