DCT

4:19-cv-04605

Levita Magnetics Intl Corp v. Attractive Surgical LLC

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Levita Magnetics International Corp. v. Attractive Surgical, LLC, 4:19-cv-04605, N.D. Cal., 08/08/2019
  • Venue Allegations: Plaintiff Levita asserts that venue is proper in the Northern District of California as it is a resident of the district. The complaint further argues for personal jurisdiction over Defendant Attractive Surgical based on alleged business negotiations, licensing discussions, and infringement threats directed at Levita within the district. The filing invokes the "customer suit exception" doctrine, seeking precedence over a prior infringement suit filed by the Defendant against one of Plaintiff's customers in another district.
  • Core Dispute: Plaintiff seeks a declaratory judgment that its magnetic surgical system does not infringe Defendant’s patents related to magnetic surgical retraction technology, and that those patents are invalid.
  • Technical Context: The technology involves systems for minimally invasive surgery that use an external magnetic controller to manipulate a detachable surgical tool inside a patient's body, reducing the number of required incisions.
  • Key Procedural History: The complaint states that prior to this action, the Defendant filed a patent infringement lawsuit against one of the Plaintiff's customers (Cleveland Clinic Foundation) in the Northern District of Ohio. The Plaintiff subsequently filed petitions for inter partes review (IPR) at the U.S. Patent and Trademark Office, challenging the validity of both patents-in-suit. The complaint also references a history of licensing negotiations between the parties and a cease and desist letter sent by the Defendant to another of the Plaintiff's customers (Duke University Medical Center).

Case Timeline

Date Event
2007-11-26 Earliest Priority Date for ’981 and ’973 Patents
2013-12-10 U.S. Patent No. 8,602,981 Issues
2015-02-10 Levita files FDA application for its Magnetic Surgical System
2016-06-13 Levita receives FDA approval for its Magnetic Surgical System
2016-07-12 U.S. Patent No. 9,386,973 Issues
2019-05-28 Attractive Surgical files suit against Cleveland Clinic Foundation
2019-07-01 Levita files IPR petitions for the ’981 and ’973 patents
2019-07-29 Attractive Surgical sends cease and desist letter to Duke Medical Center
2019-08-08 Complaint for Declaratory Judgment filed

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

U.S. Patent No. 8,602,981 - "Magnaretractor System and Method"

  • Patent Identification: U.S. Patent No. 8602981, "Magnaretractor System and Method," issued December 10, 2013.

The Invention Explained

  • Problem Addressed: The patent describes limitations in conventional laparoscopic surgery, where the number of instruments is constrained by the number of abdominal ports incised. This can lead to "instrument clutter," limited surgical capability, and the need for additional incisions, which carry risks of infection, scarring, and injury (’981 Patent, col. 1:20-29, col. 2:49-54).
  • The Patented Solution: The invention is a surgical system composed of three distinct apparatuses: an intracorporeal tool that attaches to tissue inside the patient, an extracorporeal apparatus with a magnet that is used outside the patient to manipulate the intracorporeal tool, and a placement apparatus used to insert, position, and retrieve the intracorporeal tool through a surgical port (’981 Patent, Abstract; col. 4:39-44). This allows for retraction and control of organs without occupying a surgeon's hand or a dedicated surgical port for the retraction instrument.
  • Technical Importance: The system was designed to reduce the invasiveness of laparoscopic procedures by minimizing the number of required ports and freeing the surgeon's hands for other tasks (’981 Patent, col. 2:30-38).

Key Claims at a Glance

  • The complaint seeks a declaration of non-infringement of all claims, with no specific claims identified (’981 Patent, col. 15:36-16:33). Independent claim 1 is representative of the system:
    • An intracorporeal apparatus including a body, a first end adapted to attach to tissue, and a second end with an interface for engagement with a placement apparatus.
    • An extracorporeal apparatus including a body and a source of magnetic energy to retract tissue via the intracorporeal apparatus.
    • A placement apparatus including a body, a connector to selectively engage and disengage the intracorporeal apparatus, and interfaces for control.
  • The complaint does not specify dependent claims but seeks a declaration covering all claims (Compl. ¶45).

U.S. Patent No. 9,386,973 - "Magnaretractor System and Method"

  • Patent Identification: U.S. Patent No. 9386973, "Magnaretractor System and Method," issued July 12, 2016.

The Invention Explained

  • Problem Addressed: As a continuation of the application leading to the ’981 patent, the ’973 Patent addresses the same problems of port limitations and instrument congestion in laparoscopic surgery (’973 Patent, col. 1:20-29).
  • The Patented Solution: The patent describes the same three-component system for magnetic surgical retraction, comprising a placement tool, an internal (intracorporeal) tool, and an external (extracorporeal) magnetic controller (’973 Patent, col. 2:30-51).
  • Technical Importance: This technology offers a method to manipulate internal organs without requiring an additional incision or a dedicated instrument occupying a port, aiming to simplify procedures and reduce patient trauma (’973 Patent, col. 2:49-54).

Key Claims at a Glance

  • The complaint seeks a declaration of non-infringement of all claims (Compl. ¶52). Independent claim 1 is representative of the system:
    • A placement apparatus comprising a body, a distal end connector, and a proximal end actuator for causing the connector to disengage the intracorporeal apparatus.
    • An intracorporeal apparatus comprising a body, a first end for manipulating an object, and a second end for selective engagement with the placement apparatus.
    • An extracorporeal apparatus comprising a body and a source of magnetic energy.
  • The complaint does not specify dependent claims but seeks a declaration covering all claims (Compl. ¶52).

III. The Accused Instrumentality

  • Product Identification: The Levita Magnetic Surgical System (Compl. ¶8).
  • Functionality and Market Context: The complaint describes the accused product as a system comprising three primary components: an "External Magnetic Controller," a "Magnetic Grasper," and a detachable "Grasper Tip" (Compl. ¶8). The "Magnetic Grasper" consists of a shaft that is used to deliver the "Grasper Tip" into the patient's body through a trocar; the shaft is then removed, leaving the detached tip inside to be manipulated by the external controller (Compl. p. 3). The complaint includes a diagram illustrating these components and their functions (Compl. p. 3). The system is FDA-approved for use in gallbladder removal, bariatric, and prostatectomy procedures and is marketed as reducing the number of incisions and eliminating the need for a dedicated trocar (Compl. ¶¶9-11). The complaint notes that the system is sold to medical institutions, including the Cleveland Clinic and Duke Medical Center (Compl. ¶11).

IV. Analysis of Infringement Allegations

As this is a complaint for declaratory judgment of non-infringement, it does not contain affirmative infringement allegations. The tables below summarize the potential mapping between the patent claims and the accused product, based on the complaint's description, which forms the basis of the dispute.

  • '981 Patent Infringement Allegations
Claim Element (from Independent Claim 1) Corresponding Accused Functionality for Analysis Complaint Citation Patent Citation
an intracorporeal apparatus including: a body; a first end...adapted to attach to a tissue...; a second end...comprising an interface designed to be engaged with and disengaged from a placement apparatus The "Grasper Tip," which is described as detachable, grasps target tissue, and is delivered by the "Magnetic Grasper" shaft. ¶8; p. 3 col. 15:37-43
an extracorporeal apparatus including: a body...a source of magnetic energy The "External Magnetic Controller," which is "externally positioned to magnetically attract and maneuver tip inside patient." ¶8; p. 3 col. 16:6-10
a placement apparatus including: a body, a connector proximate to a first end...adapted to selectively engage and disengage the intracorporeal apparatus The "Magnetic Grasper" shaft, which is "removed from trocar after delivery and application of tip." ¶8; p. 3 col. 16:17-22
  • '973 Patent Infringement Allegations
Claim Element (from Independent Claim 1) Corresponding Accused Functionality for Analysis Complaint Citation Patent Citation
a placement apparatus comprising a body; a distal end...comprising a connector...; and a proximal end comprising an actuator for causing the connector to disengage an intracorporeal apparatus The "Magnetic Grasper" shaft, which delivers the detachable tip. The complaint does not detail the disengagement mechanism. ¶8; p. 3 col. 16:2-9
an intracorporeal apparatus comprising...a first end...adapted to manipulate an object; and a second end...adapted to be selectively engaged with the placement apparatus The detachable "Grasper Tip," which "grasps target tissue and provides retraction." ¶8; p. 3 col. 16:10-14
an extracorporeal apparatus comprising a body; and a source of magnetic energy for interacting with the intracorporeal apparatus The "External Magnetic Controller," which is used to "magnetically attract and maneuver tip inside patient." ¶8; p. 3 col. 16:18-21
  • Identified Points of Contention:
    • Structural Questions: A primary question may be whether the Levita system's "Magnetic Grasper," which serves as both the delivery shaft and part of the ultimate tool before the tip is detached, constitutes the separate and distinct "placement apparatus" and "intracorporeal apparatus" as recited in the claims. The patent figures consistently depict these as wholly separate instruments ('981 Patent, Fig. 1), whereas the complaint’s visual suggests a more integrated design (Compl. p. 3).
    • Functional Questions: The complaint does not provide sufficient detail for analysis of the specific mechanism by which the "Grasper Tip" is disengaged from the "Magnetic Grasper" shaft. The court will require evidence on this mechanism to determine if it meets the limitations of an "actuator" and a "connector" that can "selectively engage and disengage" as required by the claims.

V. Key Claim Terms for Construction

  • The Term: "placement apparatus"

  • Context and Importance: This term's construction is critical to the infringement analysis. The dispute may center on whether the shaft of the accused "Magnetic Grasper," which delivers the detachable tip, qualifies as a "placement apparatus" distinct from the "intracorporeal apparatus" (the tip), as required by the claims. Practitioners may focus on this term because the accused product appears to integrate these functions into a single tool that is later separated, potentially creating a mismatch with the claimed three-part system.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification provides a functional definition, stating the placement apparatuses are "the tools that are used to physically position the intracorporeal apparatuses inside the patient's body" (’981 Patent, col. 7:32-35). This could support a reading that encompasses any tool performing that function.
    • Evidence for a Narrower Interpretation: The patent figures, such as Figure 1, consistently depict the placement apparatus (3) and intracorporeal apparatus (1) as structurally separate and distinct instruments (’981 Patent, Fig. 1). The detailed recitation of the placement apparatus in claim 1 may also support a narrower construction requiring a fully separate tool (’981 Patent, col. 16:17-33).
  • The Term: "a connector...adapted to selectively engage and disengage the intracorporeal apparatus"

  • Context and Importance: The definition of this term will determine whether the mechanism by which the accused "Grasper Tip" detaches from its shaft falls within the scope of the claims. The specifics of the connection and the action required for disengagement will be central.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the connector as being controlled by an "engagement interface" that can be a "button, an electrical connection to an external device or, most preferably, an engagement lever" (’981 Patent, col. 8:45-50), suggesting multiple structures could meet this limitation.
    • Evidence for a Narrower Interpretation: The claims require the connector to be part of the "placement apparatus" and to engage the "intracorporeal apparatus." If the court construes these apparatuses as needing to be structurally distinct at all times, the integrated nature of the accused device's shaft and tip prior to detachment may fall outside this narrower construction.

VI. Other Allegations

  • Indirect Infringement: This declaratory judgment action seeks a ruling of non-infringement, including no inducement or contribution (Compl. p. 13, ¶¶ a, d). The factual basis for a potential indirect infringement claim by Defendant is established in the complaint, which notes that Defendant has accused Plaintiff’s customers of direct infringement through their use of the Levita Magnetic Surgical System (Compl. ¶¶14, 16, 35). The complaint identifies Plaintiff as the "sole designer, manufacturer, and supplier" of the system, which would be a key fact in any future analysis of inducement (Compl. ¶8).
  • Willful Infringement: The complaint makes no allegation of willfulness. However, it establishes a factual basis that could be used by Defendant to later assert a willfulness claim, noting that Plaintiff was aware of the patents-in-suit as early as 2015-2017 during "protracted business discussions" and was directly accused of infringement by Defendant's counsel (Compl. ¶¶13, 21, 24).

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

  • A core issue will be one of structural correspondence: Does the accused Levita system, which uses a single tool that separates into a shaft (the placement function) and a tip (the intracorporeal function), embody the distinct three-apparatus system recited in the independent claims, or does its integrated design create a fundamental departure from the claimed invention?
  • A key evidentiary question will be one of validity: With Plaintiff having already filed inter partes review petitions against both patents-in-suit (Compl. ¶15), a central battleground will be the validity of the patents over the prior art, an issue that will proceed in parallel at both the district court and the Patent Trial and Appeal Board.
  • A dispositive procedural question will be one of jurisdiction and venue: Given the prior-filed suit against a customer in Ohio, the court must first determine if the "customer suit exception" applies to allow this declaratory judgment action by the manufacturer to proceed first in California, which will shape the path of the litigation.