Edwards Lifesciences Corp v. Boston Scientific Scimed Inc

1. Case Identification

• Case #: IPR2017-01281
• Patent #: 7,828,767
• Filed: April 18, 2017
• Petitioner(s): Edwards Lifesciences Corporation
• Patent Owner(s): Boston Scientific Scimed, Inc.
• Challenged Claims: 1-12, 14, 16, and 17

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 where the balloon is folded to form pleats that extend along its entire length, from a first weld region to a second weld region. The key aspect is that these folds are captured in the welds, ensuring that vestigial folds remain even in the cone regions of the balloon when inflated, which purportedly reduces bunching and lowers the device's profile.

3. Grounds for Unpatentability

Ground 1: Obviousness over Dlugos and Hijlkema - Claims 1, 2, 4, 5, and 8 are obvious over Dlugos in light 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 disclosed the core invention: a method of producing a balloon catheter with folds running from a distal sleeve, through the body, to a proximal sleeve, with the folds being fixed by welding. Dlugos explicitly taught that folds extending into the sleeves could be welded, which would inherently cause the folds to be maintained in the cone regions upon inflation—the very feature the patent owner used to overcome prior art during prosecution. Hijlkema was cited for its teachings on creating helical fold ridges during blow molding to facilitate orderly folding and achieve a smaller profile, particularly in the thicker cone sections. Hijlkema also taught creating folds of even material thickness (relevant to claims 4 and 8) and using a coaxial catheter with inner and outer shafts (relevant to claim 2).
  • Motivation to Combine: Petitioner contended that a person of ordinary skill in the art (POSITA) would combine these references because both sought to solve the same problem addressed by the ’767 patent: reducing bulky sections in the cone regions of an uninflated balloon to lower its profile. Dlugos itself cited Hijlkema as relevant background art. A POSITA implementing Dlugos's method would have been motivated to incorporate Hijlkema's superior folding techniques to better manage the thicker material in the cone regions that results from blow molding.
  • Expectation of Success: A POSITA would have had a high expectation of success because both references employed similar manufacturing techniques (blow molding). Applying Hijlkema’s folding method to the Dlugos balloon was presented as a feasible and predictable combination that would result in a catheter with improved folding characteristics and a reduced diameter.

Ground 2: Obviousness over Dlugos, Hijlkema, and Konstantino - Claim 3 is obvious 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 built upon the combination in Ground 1 to address the additional limitation of claim 3, which required "radially adjacent ends being overlapping." Petitioner asserted that Konstantino taught this exact feature. Konstantino disclosed folding a balloon along helical lines to form multiple flaps, and its figures illustrated that the end of each flap radially overlapped the start of the next flap, a configuration intended to minimize the balloon's profile.
  • Motivation to Combine: Petitioner argued a POSITA would combine Konstantino with Dlugos and Hijlkema for the shared purpose of minimizing the balloon profile. Since all three references aimed to create a low-profile, folded balloon, a POSITA would have found it desirable to incorporate Konstantino's overlapping fold technique into the Dlugos/Hijlkema catheter design to achieve even better performance and a more compact shape.

Ground 3: Obviousness over Dlugos and Eskaros - Claim 5 is obvious over Dlugos or Dlugos in view of Eskaros.

• Prior Art Relied Upon: Dlugos (WO 2007/020087) and Eskaros (Application # 2008/0097300).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground addressed independent method claim 5, which recited a "balloon cylinder." Petitioner presented an alternative argument. First, if "balloon cylinder" was interpreted broadly to include pre-formed balloons with tapered necks (as argued in claim construction), then Dlugos alone rendered claim 5 obvious. Second, if the term was interpreted narrowly to mean a tube of constant diameter, then the combination with Eskaros was necessary. Eskaros taught a method of making balloon catheters starting from a "tubular structure of balloon material" of essentially constant diameter, onto which micropleats were formed.
  • Motivation to Combine: A POSITA would combine Dlugos's folding method with Eskaros's constant-diameter balloon to overcome the difficulty of folding the thicker material found in the transition regions of a pre-formed, shaped balloon. Starting with a uniform cylinder as taught by Eskaros would allow for easier and more consistent folding along the entire balloon length, as suggested by Dlugos, leading to a predictably lower profile.
• Additional Grounds: Petitioner asserted numerous other obviousness challenges for the dependent claims. These grounds relied on the core combinations above, supplemented with additional references to teach specific features, such as Forman (Patent 5,501,759) for laser welding, Traxler (Application # 2001/0047149) for using a mandrel during folding, and Becker (Patent 4,251,305) for using pre-shrunk heat-shrink tubing.

4. Key Claim Construction Positions

• "Balloon Cylinder": Petitioner argued that under the broadest reasonable interpretation, this term as used in claim 5 should include a pre-formed balloon shaped to have tapered portions or necks. This interpretation was based on the examiner's own characterization of a prior art pre-formed balloon during prosecution as meeting the "balloon cylinder" limitation. This construction was central to Petitioner's argument that Dlugos alone rendered claim 5 obvious.
• "Fold": Petitioner contended that, consistent with the patent's specification, the term "fold" should be broadly construed to include "pleats, wings, and any similar structure," as well as "lobes, wraps, wrappings, and protrusions." This broad definition was used to map various structures in the prior art to the claimed "fold."

5. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1-12, 14, 16, and 17 of the ’767 patent as unpatentable.