PTAB

IPR2020-00152

Intuitive Surgical Inc v. Rex Medical LP

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1. Case Identification

2. Patent Overview

  • Title: Apparatus and Method for Resectioning Gastro-Esophageal Tissue
  • Brief Description: The ’650 patent discloses a surgical stapling apparatus featuring a pair of jaws and a movable I-beam for stapling and cutting tissue. The asserted novelty, which was used to overcome prior art during prosecution, is the I-beam's configuration to engage and align the jaws from within internal channels.

3. Grounds for Unpatentability

Ground 1: Claims 4-5, 9-18, 20, and 22-24 are obvious over Green-209 in view of Green-695 and Knodel-895

  • Prior Art Relied Upon: Green-209 (Patent 5,645,209), Green-695 (Patent 4,429,695), and Knodel-895 (Patent 5,465,895).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Green-209 teaches a modern endoscopic surgical stapler with most of the claimed features, which the patent examiner acknowledged during prosecution. However, the examiner allowed the claims based on the argument that Green-209 lacked a beam that engages the jaws "from within." Petitioner contended that Green-695 explicitly teaches this exact feature: an I-beam (knife blade assembly 30) with upper and lower shoes that engage internal passageways within the stapler jaws to ensure "optimum alignment and stabilization." The addition of Knodel-895 was argued to teach the modification of Green-209's palm grip to a pistol grip with a gear-driven closure mechanism, a well-known ergonomic alternative in surgical instruments.
    • Motivation to Combine: A POSITA would combine Green-209 and Green-695 to incorporate the superior jaw alignment and stability of Green-695's internal I-beam into the more advanced endoscopic stapler design of Green-209. This combination would yield predictable benefits, such as enabling the use of longer staple cartridges. A POSITA would further incorporate the gear and pistol grip design from Knodel-895 to improve handling and mechanical advantage, which were known design choices for such instruments.
    • Expectation of Success: Petitioner asserted success was expected because it involved applying a known technique (Green-695's internal I-beam) to a known system (Green-209's stapler) to solve a known problem (jaw alignment).

Ground 2: Claims 4-8 and 10-24 are obvious over Rothfuss in view of Green-209 and Knodel-895

  • Prior Art Relied Upon: Rothfuss (Patent 4,605,001), Green-209 (Patent 5,645,209), and Knodel-895 (Patent 5,465,895).
  • Core Argument for this Ground:
    • Prior Art Mapping: Rothfuss was presented as disclosing a surgical stapler for open surgery that contains a key claimed feature: an elongated I-beam structure that engages the jaws from within via internal passageways to provide support and alignment. Petitioner argued Rothfuss lacked features for minimally invasive surgery (MIS), such as an elongated shaft and a powered firing mechanism. These features, however, are expressly taught by Green-209, which discloses an endoscopic stapler with a long shaft and a pneumatic power system. Knodel-895 was again cited for its teaching of a geared pistol grip mechanism.
    • Motivation to Combine: A POSITA would combine Rothfuss and Green-209 to adapt the effective I-beam alignment mechanism of the Rothfuss open-surgery device for use in an MIS instrument. The benefits of MIS (e.g., faster recovery times, less pain) were well-known, providing a strong motivation to adapt existing surgical tools for this purpose. Green-209 provided the known components to achieve this adaptation.
    • Expectation of Success: Modifying an open surgery device for MIS by incorporating an elongated shaft and a power source was a common and predictable design evolution in the field, leading to a high expectation of success.

Ground 3: Claims 4-24 are obvious over McGuckin in view of Green-695

  • Prior Art Relied Upon: McGuckin (Patent 5,868,760) and Green-695 (Patent 4,429,695).
  • Core Argument for this Ground:
    • Prior Art Mapping: McGuckin discloses a powered, flexible endoscopic stapler. Petitioner argued that, like Green-209 in Ground 1, McGuckin’s device could be improved by incorporating the internal jaw alignment system taught by Green-695. Green-695 again provides the critical teaching of an I-beam with shoes that engage the jaws from within internal passageways.
    • Motivation to Combine: A POSITA would combine the references to improve the performance of the McGuckin powered stapler. By incorporating the proven I-beam alignment feature from Green-695, a POSITA would solve the known problem of maintaining jaw alignment during firing, a predictable improvement to the McGuckin device.
    • Expectation of Success: Petitioner contended that success would be reasonably expected, as it involved the straightforward application of a known stabilizing component (the Green-695 I-beam) to a similar device (the McGuckin stapler) to achieve a predictable improvement in function.

4. Arguments Regarding Discretionary Denial

  • Petitioner argued that discretionary denial under 35 U.S.C. §325(d) would be inappropriate. The petition relied on prior art and arguments that were not before the examiner during the original prosecution. Specifically, the examiner never considered the teachings of Green-695 or Rothfuss, which are central to Petitioner’s argument that an internally engaging I-beam was a known feature in the art.

5. Relief Requested

  • Petitioner requests institution of an inter partes review (IPR) and cancellation of claims 4-24 of the ’650 patent as unpatentable.