PTAB

IPR2017-01281

Edwards Lifesciences Corporation v. Boston Scientific Scimed, Inc.

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1. Case Identification

2. Patent Overview

  • Title: Balloon Design and Weld Design to Increase Ease of Re-wrapping and Decrease Withdrawal Force
  • Brief Description: The ’767 patent describes a balloon catheter designed to reduce its profile when uninflated. The purported invention is a balloon with folds or pleats that extend along the entire length of the balloon—including through its conical end sections and into the weld regions that attach the balloon to the catheter shaft—which is alleged to prevent bulky material bunching in the cone regions.

3. Grounds for Unpatentability

Ground 1: Obviousness of Claims 1, 2, 4, 5, and 8 over Dlugos in view of Hijlkema

  • Prior Art Relied Upon: Dlugos (WO 2007/020087) and Hijlkema (Patent 5,853,389).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Dlugos teaches the core invention of the ’767 patent: a method of making a balloon catheter where folds are created that run the entire length of the balloon, from a distal sleeve to a proximal sleeve, and are then fixed by welding in those sleeves. Petitioner contended this directly addresses the feature used to overcome prior art during prosecution—that folds extend into the weld region. Dlugos was argued to inherently disclose inflated and uninflated states. For dependent claims, Hijlkema was asserted to teach using helical ridges to form folds of even material thickness (claim 4) and discloses a coaxial catheter with inner and outer shafts (claim 2).
    • Motivation to Combine: A POSITA would combine these references as both address the same problem of reducing the profile of an uninflated balloon for easier navigation. Dlugos describes welding folds but not the specific folding method; a POSITA would look to known methods like Hijlkema’s, which teaches creating helical ridges during blow molding to assist folding, particularly in the thicker cone sections. Dlugos also cites Hijlkema as relevant background.
    • Expectation of Success: A POSITA would expect success because the manufacturing techniques are compatible. Both references begin with a blow-molded balloon, and applying Hijlkema’s technique of twisting the ends during molding to the balloon of Dlugos was presented as a predictable way to improve folding characteristics.

Ground 2: Obviousness of Claim 3 over Dlugos in view of Hijlkema and Konstantino

  • Prior Art Relied Upon: Dlugos (WO 2007/020087), Hijlkema (Patent 5,853,389), and Konstantino (Application # 2005/0177130).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground builds on Ground 1 to address dependent claim 3, which requires a plurality of folds with "radially adjacent ends overlapping." Petitioner asserted that while Dlugos and Hijlkema teach the base catheter, Konstantino explicitly teaches folding a balloon to create multiple flaps where the end of each flap radially overlaps the start of the next.
    • Motivation to Combine: A POSITA, seeking to minimize the balloon profile as taught by Dlugos and Hijlkema, would be motivated to incorporate the overlapping fold configuration from Konstantino. All three references share the common goal of creating a low-profile balloon catheter, and Konstantino provides a specific, known technique for achieving a compact, wrapped state.
    • Expectation of Success: The combination was asserted to be predictable, as incorporating Konstantino’s helical, overlapping folds into the manufacturing process of Dlugos/Hijlkema would predictably result in a more compact balloon.

Ground 3: Obviousness of Claims 6, 14, and 16 over Dlugos and Eskaros in view of Forman

  • Prior Art Relied Upon: Dlugos (WO 2007/020087), Eskaros (Application # 2008/0097300), and Forman (Patent 5,501,759).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground challenges method claims depending from independent claim 5. Petitioner argued Dlugos and Eskaros teach the base method of making a folded balloon catheter. Forman was introduced to teach the specific limitations of using a laser for welding (claim 6) and using heat shrink material over the weld regions (claims 14 and 16). Forman explicitly discloses using a laser to create fusion bonds and using heat shrink tubing to assist in the process.
    • Motivation to Combine: A POSITA implementing the method of Dlugos/Eskaros would be motivated to use Forman’s laser welding and heat shrink techniques. Dlugos teaches "welding" generally, and Forman was presented as a leading authority on laser welding for catheters, a well-known and advantageous technique for creating robust, narrow seals. The combination would achieve the shared goal of a reduced-profile catheter with strong bonds.
    • Expectation of Success: Success would be expected because laser welding was a conventional and highly refined technique for joining catheter components. Applying Forman’s established methods to the balloons of Dlugos or Eskaros would be a straightforward implementation for a POSITA.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including combinations of Dlugos and Eskaros with Traxler (for using a mandrel and folding tool), Forman and Becker (for pre-shrinking heat shrink material), and Dlugos with Bampos (for teaching creases extending from the proximal to the distal end).

4. Key Claim Construction Positions

  • "Balloon Cylinder": Petitioner argued this term should be construed, under its broadest reasonable interpretation, to include not only a simple tube of constant diameter but also a pre-formed balloon shaped to have tapered portions or necks. This construction was based on the examiner's characterization of a prior art balloon during prosecution and was important for the argument that Dlugos alone renders claim 5 obvious.
  • "Fold": Petitioner asserted this term should be given its broad definition from the specification, which states it "includes pleats, wings, and any similar structure," as well as "lobes," "wraps," "wrappings," and "protrusions." This broad construction was used to map various folding techniques from the prior art onto the claims.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-12, 14, 16, and 17 of Patent 7,828,767 as unpatentable.