Cook Inc v. Medtronic Vascular Inc

1. Case Identification

• Case #: IPR2018-01569
• Patent #: 8,206,427
• Filed: September 4, 2018
• Petitioner(s): Cook Incorporated, Cook Group Incorporated, and Cook Medical LLC
• Patent Owner(s): Medtronic Vascular, Inc.
• Challenged Claims: 1-42

2. Patent Overview

• Title: Apparatus and Methods for Endoluminal Graft Placement
• Brief Description: The ’427 patent discloses methods and devices for treating vascular conditions, such as aortic aneurysms, by introducing and deploying multi-component endoluminal grafts within a patient's arterial system.

3. Grounds for Unpatentability

Ground 1: Claims 1-42 are obvious over Lazarus in view of Schaer.

• Prior Art Relied Upon: Lazarus (Patent 5,871,536) and Schaer (a 1992 journal article titled Treatment of Malignant Esophageal Obstruction With Silicone-Coated Metallic Self-Expanding Stents).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Lazarus disclosed the primary limitations of the independent claims, including a method for introducing a bifurcated vascular graft with an anchor section and connector sections (legs) to treat an aneurysm in a primary artery that branches. However, Lazarus taught deploying a single, pre-formed bifurcated graft. Petitioner contended that the claimed steps of thereafter introducing separate first and second tubular grafts to extend from the connector sections into the branch arteries were not explicitly taught by Lazarus but were an obvious modification.
  • Motivation to Combine: Petitioner asserted that a person of ordinary skill in the art (POSITA) would be motivated to modify the Lazarus method to address the known clinical problem of improper graft sizing. A pre-formed graft that is too short fails to seal the aneurysm, while one that is too long can occlude branch vessels. Schaer directly addressed this problem by teaching the use of a second, overlapping stent to extend the length of an initial stent that was too short. A POSITA would combine Schaer's known solution for extending a prosthesis with the Lazarus graft to create a customizable, modular system that ensures proper length and sealing, thereby avoiding the risks of improper sizing.
  • Expectation of Success: A POSITA would have a high expectation of success because the combination involved applying a known technique (overlapping grafts from Schaer) to a known device (the bifurcated graft from Lazarus) to achieve the predictable result of creating a continuous, properly sized flow path.

Ground 2: Claims 1-42 are obvious over Lazarus in view of Dumon.

• Prior Art Relied Upon: Lazarus (Patent 5,871,536) and Dumon (Patent 5,236,446).
• Core Argument for this Ground:
  • Prior Art Mapping: As in Ground 1, Petitioner relied on Lazarus to teach the base bifurcated graft structure and its placement for treating aneurysms. The key inventive concept alleged by the Patent Owner during prosecution was the separate, sequential introduction of the bifurcated structure followed by the tubular leg grafts. Petitioner argued this sequential, modular assembly was taught by Dumon.
  • Motivation to Combine: Petitioner argued that the method of deploying the one-piece graft in Lazarus was complex and risky, requiring difficult catheterization to maneuver the second leg of the graft across the aortic bifurcation into the contralateral iliac artery. Dumon disclosed a simpler and safer method of creating a bifurcated prosthesis in situ by separately introducing and deploying multiple components. A POSITA would be motivated to apply Dumon's simpler, modular assembly method to the Lazarus graft structure to simplify the deployment procedure, reduce procedural complexity and time, and avoid the risks (e.g., kinking, twisting) associated with the method taught by Lazarus.
  • Expectation of Success: A POSITA would expect the combination to succeed because it involved substituting one known endoluminal deployment technique (Lazarus's single-piece deployment) with another, simpler known technique (Dumon's modular deployment) to achieve the predictable outcome of a properly placed bifurcated graft.

4. Key Claim Construction Positions

• "Simultaneously": Petitioner argued that certain dependent claims require anchoring a graft "simultaneously" within a connector section and a branch artery. Because the ’427 patent's disclosure of deploying self-expanding grafts from a sheath necessarily means one end expands before the other, "simultaneously" cannot mean "at the exact same time." Petitioner proposed that under the broadest reasonable interpretation, the term should be construed to mean "in the same procedural step," such as the single step of retracting a delivery sheath.
• "Introducing" (Claim 15): Petitioner noted that during prosecution, the Patent Trial and Appeal Board (PTAB) determined that claim 15 does not require the "anchor section" and "first tubular graft" to be introduced in a single step. Therefore, Petitioner asserted that the "introducing" step of claim 15 covers introducing the required components in one or more steps, which is consistent with the modular assembly methods taught by the prior art combinations.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under §325(d) would be inappropriate. Although the Lazarus, Schaer, and Dumon references were cited in a lengthy Information Disclosure Statement (IDS) during the original prosecution, Petitioner asserted that there is no evidence the Examiner substantively considered them, either individually or in the combinations proposed in the petition. Petitioner contended that the Board should institute review because the arguments and specific combinations presented were never before the Patent Office.

6. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1-42 of the ’427 patent as unpatentable under 35 U.S.C. §103.