PTAB

IPR2017-01023

OBalon Therapeutics Inc v. Polyzen Inc

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1. Case Identification

2. Patent Overview

  • Title: Low-Pressure Medical Balloons and Method of Making Same
  • Brief Description: The ’832 patent discloses a method for manufacturing low-pressure medical balloons, intended as a non-allergenic alternative to latex. The method involves providing a thin thermoplastic polymeric film, heating it, and then using "thermo-vacuum molding" to form two separate half-sections, which are subsequently bonded together along their edges to form the final balloon.

3. Grounds for Unpatentability

Ground 1: Anticipation by Rakonjac - Claims 1, 6, 7, 10, and 14-18 are anticipated under 35 U.S.C. §102 by Rakonjac.

  • Prior Art Relied Upon: Rakonjac (Patent 5,316,605).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Rakonjac teaches a method of manufacturing inflatable three-dimensional figures that discloses every element of independent claim 1. Rakonjac describes providing a thin plastic sheet (e.g., polyvinyl chloride), heating it to a softening temperature, using a vacuum-forming operation to create contoured sheet sections, and then heat-welding two mating sheets together along their peripheral edges. Petitioner asserted that Rakonjac explicitly states this general process is "old in the art." Rakonjac also allegedly meets limitations of various dependent claims, including teaching a balloon thickness of 5 mils (anticipating claims 14 and 15) and using a thermo-vacuum molding technique (anticipating the neck-to-body ratio of claims 16-18 under the patent's own logic).

Ground 2: Obviousness over Rakonjac and Shah '915 - Claims 3, 4, and 10-12 are obvious over Rakonjac in view of Shah '915.

  • Prior Art Relied Upon: Rakonjac (Patent 5,316,605) and Shah '915 (Patent 5,833,915).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner contended that while Rakonjac teaches the core vacuum-forming and bonding process, it does not explicitly disclose using polyurethane film (claims 3-4) or the specific bonding techniques listed in claim 10 (e.g., radio-frequency welding). Shah '915, which is the Patent Owner's own prior art and is incorporated by reference into the ’832 patent, allegedly remedies these deficiencies. Shah '915 teaches a method for radio-frequency (RF) welding thin polyurethane films to create medical products, including catheter balloon cuffs formed from two half-sections.
    • Motivation to Combine: A POSITA would combine these references because Shah '915 teaches the benefits of using polyurethane as a superior alternative to latex for medical devices but does not teach a method for forming the balloon half-sections prior to welding. Rakonjac provides a known, "old in the art" vacuum thermoforming process suitable for shaping such half-sections. A POSITA would therefore apply Rakonjac's forming technique to Shah '915's superior material and welding process to predictably manufacture improved low-pressure polyurethane balloons.
    • Expectation of Success: Success was expected because the combination involved applying a known forming technique (Rakonjac) to a material (polyurethane from Shah '915) for its intended purpose in a related field (inflatable medical devices).

Ground 3: Obviousness over Shah '915 and Dyck - Claims 1-8, 10-12, and 14-18 are obvious over Shah '915 in view of Dyck.

  • Prior Art Relied Upon: Shah '915 (Patent 5,833,915) and Dyck (Patent 4,576,156).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground presents an alternative primary invalidity argument. Petitioner asserted that Shah '915 teaches most elements of the challenged claims, including a method of welding two polyurethane half-sections to form a catheter balloon. However, Shah '915 does not teach vacuum forming. Dyck, which was cited during the ’832 patent's prosecution, allegedly supplies this missing element. Dyck discloses manufacturing prophylactic devices from thin thermoplastic polyurethane and teaches a process that includes heating the film and applying a vacuum to "bring about a uniformity in wall thickness" and create a "pinhole free device."
    • Motivation to Combine: A POSITA seeking to manufacture the polyurethane catheter balloons of Shah '915 would need a method to form the half-sections before welding. Dyck provides an advantageous and known solution by teaching vacuum forming for the same type of material (polyurethane) to achieve desirable properties like uniform wall thickness and greater elasticity. Both references address the same problem of creating improved thermoplastic medical devices as alternatives to latex.
    • Expectation of Success: The combination was argued to be predictable, as it involves incorporating a known vacuum forming step from Dyck into the manufacturing process of Shah '915 to produce the balloon half-sections, a well-understood and common-sense design choice.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including combinations of Rakonjac with Araki (for uniform wall thickness) and Meyer (for semi-spherical, inverted balloons), as well as three-way combinations based on Shah '915 and Dyck with Araki or Meyer to address further dependent claim limitations.

4. Relief Requested

  • Petitioner requests institution of an inter partes review (IPR) and cancellation of claims 1-18 of the ’832 patent as unpatentable.