PTAB

IPR2019-01173

Auris Health Inc v. Intuitive Surgical Operations Inc

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1. Case Identification

2. Patent Overview

  • Title: Navigation Guidance for a Steerable Endoscope
  • Brief Description: The ’601 patent discloses methods for navigating a steerable instrument, such as an endoscope, within a patient’s anatomy. The method involves an operator establishing anatomic landmarks, registering those landmarks to a computer model of the anatomy, and then receiving visual guidance on a display to steer the instrument along a path through the landmarks to a target site.

3. Grounds for Unpatentability

Ground 1: Anticipation over Ganatra - Claims 1-2 and 5-9 are anticipated by Ganatra under 35 U.S.C. §102.

  • Prior Art Relied Upon: Ganatra (Application # 2009/0227861).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued Ganatra discloses every element of the challenged claims. Ganatra describes a method for navigating a bronchoscope using a computer model of a patient’s bronchial tree. Petitioner asserted that Ganatra’s user-selected “designated points” (e.g., branching points in an airway) are equivalent to the claimed "anatomic landmarks." An operator "requests" landmark establishment by inputting these points into the system. In response, Ganatra records the instrument's position at these landmarks and registers this information to the computer model. Critically, Petitioner argued that Ganatra’s disclosure of using superimposed arrows to guide an operator through a sequence of designated points during an initial registration process meets the limitation of “providing guidance for navigating...along a path through a plurality of anatomic landmarks...to a target location.”
    • Key Aspects: The argument hinges on interpreting Ganatra’s registration guidance as fulfilling the patent’s requirement for navigation guidance to a target, asserting a person of ordinary skill in the art (POSA) would understand this application.

Ground 2: Obviousness over Ganatra and Soper - Claims 1-3 and 5-18 are obvious over Ganatra in view of Soper under 35 U.S.C. §103.

  • Prior Art Relied Upon: Ganatra (Application # 2009/0227861) and Soper (Patent 7,901,348).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner contended that to the extent Ganatra is found not to explicitly teach providing guidance through landmarks to a final target site, Soper provides this missing element. Soper describes a visually-assisted guidance system for an endoscope that explicitly displays "intended navigation routes" as dotted lines or provides an arrow indicating a direct path to a target biopsy point on a 3-D model. Soper’s teaching of displaying a complete path to a target remedies any alleged deficiency in Ganatra. For claim 3, which requires including an image with the landmark information, Petitioner argued that Soper teaches capturing and storing endoscopic images at each branching point to create a dynamic airway model, compensating for patient motion.
    • Motivation to Combine: A POSITA designing a system like Ganatra’s would have been motivated to consult analogous systems like Soper to improve navigation guidance. Both references address the same problem of guiding an endoscope through a patient's airways using a computer model. A POSITA would combine Soper's explicit path display features with Ganatra’s system to provide more effective and clear guidance to a target, a simple and predictable improvement. Similarly, incorporating Soper’s image capture at landmarks would be a known technique to enhance Ganatra’s registration accuracy.
    • Expectation of Success: Combining Soper's visual guidance techniques (displaying a path line) with Ganatra’s system would have been a straightforward integration of known software features, presenting no technical hurdles and yielding predictable results.

Ground 3: Obviousness over Ganatra, Larkin, and optionally Soper - Claims 4 and 18 are obvious over Ganatra and Larkin, with or without Soper, under §103.

  • Prior Art Relied Upon: Ganatra (Application # 2009/0227861), Larkin (Application # 2007/0156019), and optionally Soper (Patent 7,901,348).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground addresses claim 4, which requires the landmark information to include "shape information" of the steerable instrument. Petitioner argued that while Ganatra describes matching the instrument's path to the "characteristic curvatures" of the airways, it does not explicitly disclose a shape-sensing mechanism. Larkin remedies this by teaching a strain sensor system using Fiber Bragg Gratings (FBGs) to determine the precise shape and bend of a medical instrument in real time.
    • Motivation to Combine: A POSITA seeking to improve the accuracy of Ganatra’s system, particularly its ability to track instrument movement through anatomical curvatures, would have been motivated to incorporate a known shape-sensing technology. Larkin provides a well-known solution for this exact purpose. Integrating Larkin's FBG-based shape sensing into Ganatra’s bronchoscope would be an obvious way to provide the data needed to better track the instrument's contour through the bronchial tree.
    • Expectation of Success: Integrating known sensor technology like that in Larkin into an endoscope like Ganatra's was a well-understood and routine engineering task at the time, with a high expectation of successfully providing real-time shape data.

4. Key Claim Construction Positions

  • "anatomic landmark": Petitioner proposed this term should be construed as "a user established anatomical feature." This construction is central to mapping Ganatra's user-selected "designated points" onto the claims.
  • "a path through...anatomic landmarks": Petitioner proposed this should mean "a path that runs in one side of the anatomic landmark and out of another." This construction was used to distinguish the claimed invention from prior art that used external markers on the surface of a patient, arguing the claimed path must traverse the internal landmarks themselves.
  • "fixed reference frame": For dependent claim 11, Petitioner proposed this means "a reference frame that does not move during a medical procedure." This was used to argue that Ganatra's electromagnetic tracking system, which is fixed relative to the patient, meets this limitation.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and cancellation of claims 1-18 of the ’601 patent as unpatentable.