PTAB

IPR2013-00493

TriVascular Inc v. Samuels Shaun

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Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Inflatable Intraluminal Stent and Method for Affixing Same within the Human Body
  • Brief Description: The ’575 patent describes an inflatable intraluminal stent for treating conditions such as aneurysms. The stent uses an inflatable cuff with a "friction-enhancing" outer surface to anchor itself securely within a tubular body structure, like a blood vessel, without penetrating or damaging the vessel wall.

3. Grounds for Unpatentability

Ground 1: Claims 1-2, 6-15, and 18-24 are anticipated by or obvious over Samuels ’851

  • Prior Art Relied Upon: Samuels (Patent 5,423,851)
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Samuels ’851, by the same inventor, discloses every element of the challenged claims. Specifically, Samuels ’851 teaches an inflatable cuff stent that can be positioned and engage the walls of a tubular structure without using its optional barbs and thus without penetration, particularly at lower inflation levels. The reference explicitly states the device can be optimally positioned "without causing damage to the surrounding tissue," directly mapping to the core functionality of the ’575 patent claims.
    • Motivation to Combine (for §103): For the obviousness contention, Petitioner asserted that the only meaningful difference is the optional presence of barbs in Samuels ’851. A person of ordinary skill in the art (POSITA) would have been motivated to remove these barbs to arrive at the claimed invention. This motivation stemmed from common knowledge at the time regarding problems associated with barbs in intraluminal devices and a clear trend toward developing non-vessel-piercing anchoring methods, as taught by other contemporaneous art.
    • Expectation of Success: A POSITA would have had a high expectation of success because Samuels ’851 itself teaches that its device can function for positioning and repositioning without the barbs engaging the vessel wall. Removing them would be a predictable modification to achieve a non-penetrating stent.

Ground 2: Claims 1-6, 11, 14-17, and 21 are anticipated by or obvious over Rogers ’024

  • Prior Art Relied Upon: Rogers (Patent 5,534,024)
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner contended that Rogers ’024 anticipates or renders obvious the challenged claims by disclosing an intraluminal stenting graft for treating aneurysms without penetrating the vessel. Rogers ’024 teaches inflatable portions with inflatable protrusions positioned circumferentially to maintain the device in place through friction. These protrusions serve the exact purpose of the claimed "friction-enhancing outer surface." Crucially, Rogers ’024 achieves fixation without disclosing or requiring barbs or any other penetrating mechanism.

Ground 3: Claims 1-24 are obvious over Samuels ’851 in view of Rogers ’024

  • Prior Art Relied Upon: Samuels (Patent 5,423,851), Rogers (Patent 5,534,024)

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground combined the teachings of the primary references. Samuels ’851 provided the base inflatable stent design, while Rogers ’024 provided the explicit teaching that barbs are unnecessary for anchoring such a device.
    • Motivation to Combine: A POSITA looking at the Samuels ’851 device would have recognized the known disadvantages of its barbs. Rogers ’024, which addresses the same problem of aneurysm repair, demonstrates a successful barb-less design using only inflatable protrusions for fixation. This would have provided a clear motivation to modify Samuels ’851 by simply removing the barbs to create a wholly non-penetrating device.
    • Expectation of Success: The combination was argued to be a predictable solution, as a POSITA would expect that removing the barbs from Samuels '851 and relying on its inherent friction-enhancing surface—a method confirmed to be effective by Rogers ’024—would successfully anchor the stent.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including combinations of Samuels ’851 with Lazarus (’088 patent), Rhodes (’117 patent), and Lane (’029 patent), among others. These grounds relied on similar theories of modifying the base Samuels ’851 device by removing its barbs, with the secondary references providing explicit teachings of non-penetrating friction surfaces, materials promoting tissue ingrowth, or other barb-less fixation techniques as the motivation.

4. Key Claim Construction Positions

  • "means for injecting an inflation material...": Petitioner argued this means-plus-function term should be construed according to the structure disclosed in the specification, namely as an "inflation tubing connected to an inflation syringe filled with inflation material."
  • "means for securing an intraluminal medical device...": Similarly, Petitioner proposed this term be construed as the corresponding disclosed structure: "a biologically inert adhesive."
  • "friction-enhancing outer surface": Petitioner construed this term to mean surface features of an inflatable cuff (such as inflatable ridges, nubs, or bumps) that engage or secure the stent to the interior wall of a tubular structure without penetrating, harming, or damaging the tissue of the walls.

5. Key Technical Contentions (Beyond Claim Construction)

  • "fully inflated" Lacks Specification Support: Petitioner heavily contended that the claim limitation "when the cuff is fully inflated" lacks any antecedent basis or support in the ’575 patent’s specification. It was argued that this term was added during prosecution solely to overcome a rejection based on Samuels ’851. Petitioner asserted that because the term is unsupported, it should be interpreted broadly to mean inflated just enough to affix the cuff to the vessel wall but not so much that it penetrates the structure, a condition disclosed in the prior art.

6. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of all challenged claims, 1-24, of the ’575 patent as unpatentable.