DCT

1:18-cv-01359

Intuitive Surgical Inc v. Auris Health Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-01359, D. Del., 08/31/2018
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Auris Health, Inc. is a Delaware corporation and therefore resides in the district.
  • Core Dispute: Plaintiff alleges that Defendant’s Monarch Endoscopy Platform infringes eight patents related to robotic-assisted surgery systems, tool interfaces, control methods, and user guidance features.
  • Technical Context: The dispute is in the field of robotic-assisted, minimally invasive surgery, a market where advanced control systems and specialized tool interfaces are critical for enabling complex procedures through small incisions or natural orifices.
  • Key Procedural History: The complaint notes that Defendant’s co-founder and CEO, Frederic H. Moll, also co-founded Plaintiff Intuitive Surgical and served as its first CEO. Plaintiff alleges it provided Defendant with notice of the patents-in-suit via a letter dated August 3, 2018, approximately four weeks before filing the complaint. For one patent, the complaint alleges pre-suit knowledge dating back to 2016 based on a citation in one of Defendant's own issued patents. Subsequent to issuance, several of the patents-in-suit have had some or all asserted claims disclaimed following inter partes review proceedings.

Case Timeline

Date Event
1995-01-01 Intuitive Surgical, Inc. founded
1998-08-04 ’200 Patent Priority Date
1998-12-08 ’701, ’447, and ’906 Patents Priority Date
1999-01-01 Intuitive’s da Vinci® System launched
2000-04-03 ’276 and ’056 Patents Priority Date
2001-06-12 ’200 Patent Issue Date
2002-12-10 ’701 Patent Issue Date
2003-02-18 ’906 Patent Issue Date
2004-10-05 ’056 Patent Issue Date
2007-01-01 Auris Health, Inc. founded
2007-06-13 ’473 Patent Priority Date
2009-03-26 ’601 Patent Priority Date
2012-03-27 ’447 Patent Issue Date
2013-12-31 ’473 Patent Issue Date
2014-08-12 ’601 Patent Issue Date
2016-05-26 Auris’ ARES System receives FDA determination
2016-09-27 ’276 Patent Issue Date
2018-03-22 Auris’ Monarch Platform receives FDA determination
2018-08-03 Intuitive sends notice letter to Auris
2018-08-31 Complaint Filing Date

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

U.S. Patent No. 6,491,701 - "Mechanical actuator interface system for robotic surgical tools", Issued December 10, 2002

The Invention Explained

  • Problem Addressed: The patent's background describes the challenge of frequent tool changes during robotic surgery, noting that the time required to remove one tool, attach another, and reconfigure the robotic system for the new tool's specific characteristics increases the overall surgery time and complexity (’701 Patent, col. 2:17-29).
  • The Patented Solution: The invention proposes a robotic surgical tool that incorporates a memory structure. This memory communicates with the robotic system's processor to provide tool-specific data, such as compatibility verification, tool-type identification, and calibration offsets (’701 Patent, col. 3:1-20). This allows the system to automatically reconfigure its programming for different tool geometries and drive systems, thereby reducing the delay and potential for error associated with manual tool changes (’701 Patent, col. 4:54-61).
  • Technical Importance: By automating the process of tool recognition and system reconfiguration, the invention aimed to improve the safety, speed, and reliability of robotic surgical procedures (’701 Patent, col. 2:48-56).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶27).
  • Essential elements of Claim 1 include:
    • A minimally invasive surgical instrument with a shaft and a working end.
    • An end effector mounting formation at the working end, displaceable about at least two axes.
    • Elongate elements (e.g., cables) to cause pivotal movement of the end effector mounting formation.
    • A support base at the opposed end of the shaft.
    • At least three angularly displaceable "spools" mounted on the support base, to which the elongate elements connect, allowing selective pulling of the elements.
  • Note: Claim 1 was subsequently disclaimed in an inter partes review proceeding (IPR2019-01532).

U.S. Patent No. 8,142,447 - "Mechanical actuator interface system for robotic surgical tools", Issued March 27, 2012

The Invention Explained

  • Problem Addressed: As a divisional of the application leading to the ’701 Patent, the ’447 Patent addresses the same technical challenge: improving the efficiency and safety of exchanging surgical tools on a robotic manipulator during a procedure (’447 Patent, col. 2:17-29).
  • The Patented Solution: The patent describes a sterile adapter for coupling the surgical tool's interface to the tool holder on the manipulator. This adapter facilitates the mechanical and electrical connection between the tool and the manipulator while maintaining a sterile barrier, which is crucial for preventing contamination of the non-sterile manipulator components (’447 Patent, col. 9:55-61; col. 11:1-12). The adapter includes movable bodies that align and engage with both the tool's driven elements and the manipulator's drive elements (’447 Patent, col. 10:62-67).
  • Technical Importance: The invention provides a robust and sterile method for rapidly coupling different surgical instruments to a robotic manipulator, a key enabling technology for performing complex procedures that require multiple tools.

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (Compl. ¶34).
  • The language of independent claim 1 of the ’447 Patent is identical to that of claim 1 of the ’701 Patent, as described above.
  • Note: Claim 1 was subsequently disclaimed in an inter partes review proceeding (IPR2019-01533).

U.S. Patent No. 8,620,473 - "Medical robotic system with coupled control modes", Issued December 31, 2013

  • Technology Synopsis: The patent describes "coupled control modes" for a multi-arm robotic surgical system. In these modes, a surgeon's direct manipulation of one instrument (e.g., a primary surgical tool) causes the system to automatically and intelligently move other instruments (e.g., an endoscope) to achieve a secondary objective, such as maintaining an optimal view of the surgical site (’473 Patent, Abstract).
  • Asserted Claims: At least independent claim 19 (Compl. ¶44).
  • Accused Features: The complaint accuses the Monarch system of infringement, suggesting it employs similar coupled control functionalities between its instruments and/or endoscope (Compl. ¶44).

U.S. Patent No. 9,452,276 - "Catheter with removable vision probe", Issued September 27, 2016

  • Technology Synopsis: The technology involves a catheter system where a vision probe is first used to navigate to a target site. The vision probe is then removed, and a medical tool is inserted through the same catheter lumen to perform a task. The system includes control logic to maintain the catheter's desired position and orientation after the vision probe is removed (’276 Patent, Abstract).
  • Asserted Claims: At least independent claim 1 (Compl. ¶51).
  • Accused Features: The complaint alleges the Monarch platform infringes by using a removable vision probe that is swapped for other medical tools (Compl. ¶51).

U.S. Patent No. 6,246,200 - "Manipulator positioning linkage for robotic surgery", Issued June 12, 2001

  • Technology Synopsis: The invention is a manually positionable linkage system used for setting up surgical manipulators before a procedure. The linkage has joints that can be locked and unlocked by a brake system, and sensors within the joints transmit position data to a processor, allowing the system to perform coordinate transformations for aligning the surgeon's controls with the tool's movements (’200 Patent, Abstract).
  • Asserted Claims: At least independent claim 1 (Compl. ¶58).
  • Accused Features: The Monarch system's manipulator positioning and setup hardware is accused of infringement (Compl. ¶58). Note: Claim 1 was subsequently disclaimed in an inter partes review proceeding (IPR2019-01448).

U.S. Patent No. 6,800,056 - "Endoscope with guiding apparatus", Issued October 5, 2004

  • Technology Synopsis: This patent describes an endoscope system with a separate "guiding apparatus" or tracking rod. The guide can be advanced, conformed to a path defined by the endoscope's steerable tip, and then made rigid. The main body of the endoscope can then be advanced over this rigidized guide like a monorail, providing stability while navigating tortuous paths (’056 Patent, Abstract).
  • Asserted Claims: At least independent claim 1 (Compl. ¶65).
  • Accused Features: The Monarch platform's endoscopic guidance mechanisms are accused of infringing this patent (Compl. ¶65).

U.S. Patent No. 8,801,601 - "Method and system for providing visual guidance to an operator for steering a tip of an endoscopic device toward one or more landmarks in a patient", Issued August 12, 2014

  • Technology Synopsis: The invention provides a navigation system that displays graphical cues, such as vectors or arrows, on the surgeon's display. These graphics provide directional guidance, steering the operator toward one or more pre-defined anatomical landmarks within the patient, which are tracked relative to the endoscope's position (’601 Patent, Abstract).
  • Asserted Claims: At least independent claim 1 (Compl. ¶75).
  • Accused Features: The Monarch platform's visual guidance and user interface features are accused of infringement (Compl. ¶75). Note: All claims were subsequently cancelled in an inter partes review proceeding (IPR2019-01173).

U.S. Patent No. 6,522,906 - "Devices and methods for presenting and regulating auxiliary information on an image display of a telesurgical system to assist an operator in performing a surgical procedure", Issued February 18, 2003

  • Technology Synopsis: The patent describes a system for overlaying or integrating auxiliary information (e.g., pre-operative images like CT scans, patient vital signs) onto the main endoscopic video display. This allows a surgeon to reference critical data without looking away from the surgical field (’906 Patent, Abstract).
  • Asserted Claims: At least independent claim 51 (Compl. ¶85).
  • Accused Features: The Monarch system's display, which may present auxiliary data to the operator, is accused of infringement (Compl. ¶85).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentality is the Auris Health Monarch Endoscopy Platform ("Monarch") (Compl. ¶20, 23).
  • Functionality and Market Context: The Monarch platform is a robotic surgical system designed for endoscopic procedures, with its first application being bronchoscopy (Compl. ¶21). The complaint alleges it is a "platform technology" intended to compete with Plaintiff's current and future robotic systems (Compl. ¶18, 21). Auris received a substantial equivalence determination from the FDA for the Monarch platform on March 22, 2018, and subsequently announced an "aggressive timeline for its development and deployment" (Compl. ¶20, 21).

IV. Analysis of Infringement Allegations

The complaint references preliminary infringement contentions in Attachments A through H, which were not publicly filed with the complaint. Therefore, a detailed claim chart summary cannot be constructed. The narrative infringement theory is summarized below.

No probative visual evidence provided in complaint.

For each of the eight patents-in-suit, the complaint makes a general allegation that Auris directly infringes, contributorily infringes, and/or induces infringement "through the development and subsequent making, using, selling, offering for sale, and/or importing of Monarch" (Compl. ¶23). For several patents, the complaint specifically alleges that "Doctors who use Monarch directly infringe" the asserted claims, supporting a theory of induced infringement against Auris (Compl. ¶36, 67, 77, 87).

  • Identified Points of Contention:
    • Scope Questions: For the ’701 and ’447 patents, a central issue may be whether the mechanical interface of the Monarch system's tools contains structures that fall within the scope of the term "spools," a key element of the asserted claims. The patents' specifications describe these structures in the context of a particular interface for laparoscopic instruments, raising the question of whether the term can be construed to cover the potentially different interface of a flexible endoscopy platform.
    • Technical Questions: A key evidentiary question will be what proof Plaintiff offers to demonstrate that the Monarch platform—a flexible robotic endoscope—practices the specific methods and embodies the particular apparatus structures claimed in the patents-in-suit. For example, for the ’200 patent, Plaintiff will need to show how the Monarch system's setup arms map onto the claimed "manipulator positioning linkage."

V. Key Claim Terms for Construction

  • The Term: "spools" (from Claim 1 of the ’701 and ’447 patents).
  • Context and Importance: This term appears in the final limitation of the asserted independent claim and describes a core component of the claimed tool-to-manipulator interface. The infringement analysis for these patents may depend heavily on whether the Monarch platform's tool interface has components that meet the definition of "spools."
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification does not provide a formal definition of "spools." A party arguing for a broader construction may point to the functional description, where these components are part of an interface that mechanically couples the tool's end effector to drive motors in the manipulator, suggesting any functionally equivalent rotatable element could suffice (’701 Patent, col. 9:35-40).
    • Evidence for a Narrower Interpretation: The patent figures depict the "driven elements" (118) as specific disc-like structures with pins (122) for engagement (’701 Patent, FIG. 6). A party arguing for a narrower construction may contend that the term "spools" should be limited to these disclosed embodiments or structures with similar disc-like and pin-based features.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges both induced and contributory infringement for several patents. The basis for inducement is the allegation that Auris's customers, such as doctors, directly infringe by using the Monarch system (Compl. ¶36, 67, 77, 87). The basis for contributory infringement is the allegation that the Monarch system has "no substantial non-infringing uses" (Compl. ¶35, 66, 76, 86).
  • Willful Infringement: Willfulness is alleged for all eight patents. For most, knowledge is alleged to have occurred as of August 6, 2018, three days after Plaintiff sent a notice letter (Compl. ¶30, 40, 47, 54, 68, 78, 81). For the ’447 Patent, the complaint alleges pre-suit knowledge "since at least November 29, 2016," based on Defendant Auris's own U.S. Patent No. 9,504,604 citing the application that matured into the ’447 Patent (Compl. ¶37). For the ’200 and ’906 patents, knowledge is alleged "at least as of the filing of this Complaint" (Compl. ¶61, 91).

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

  • A core issue will be one of claim scope and disclaimer: Several asserted claims, including the lead claims of the ’701, ’447, and ’200 patents, were disclaimed during subsequent IPR proceedings. The case will depend on which claims, if any, survive and how remaining claim terms are construed, particularly whether terms rooted in the context of laparoscopic surgical tools can be interpreted to cover the accused flexible endoscopy system.
  • A key evidentiary question will be one of technical mapping: As the complaint’s detailed infringement charts were not provided, the case will turn on the specific factual evidence Plaintiff presents to map the structure and operation of the Monarch platform onto the limitations of the asserted claims, especially for patents directed at specific mechanical linkages, control systems, and user interfaces.
  • A critical dispute will concern willful infringement and pre-suit knowledge: The allegation that Auris was aware of the technology in the ’447 patent as a result of its own patent prosecution activities raises a significant question of fact regarding pre-suit knowledge and potential objective recklessness, which could expose Defendant to enhanced damages if infringement is found.