PTAB

IPR2017-00812

OBalon Therapeutics Inc v. Polyzen Inc

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Petition
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1. Case Identification

2. Patent Overview

  • Title: Therapeutic Intervention Systems Employing Implantable Balloon Devices
  • Brief Description: The ’306 patent discloses a method for treating a patient by introducing a multi-layer balloon into a physiological locus and inflating it. The balloon is manufactured from two vacuum-thermoformed half-sections of a multi-layer film which are bonded together. The film includes a sealing layer that imparts a gas barrier character and at least one thermoplastic layer that alone lacks such character.

3. Grounds for Unpatentability

Ground 1: Obviousness over Gau, Shah ’915, and Throne - Claims 1-3, 5, and 10-14 are obvious over Gau, Shah ’915, and Throne.

  • Prior Art Relied Upon: Gau (Patent 5,084,061), Shah ’915 (Patent 5,833,915), and Throne (“Technology of Thermoforming” textbook).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the combination teaches all limitations of the challenged claims. Gau disclosed the foundational method of introducing a "flattened spherical" intragastric balloon with an inflation element into a patient’s stomach for weight control. Shah ’915 taught manufacturing balloons from polyurethane film by forming two half-sections and welding them along a peripheral seam, noting the superiority of polyurethane over rubber for medical devices. Throne taught manufacturing multi-layer shapes using vacuum thermoforming, specifically describing a cost-effective multi-layer sheet with an expensive, thin gas-barrier layer (e.g., PVDC, EVOH) laminated between less expensive but durable thermoplastic polymer layers that lack gas-barrier properties.
    • Motivation to Combine: A POSITA would combine these references to improve upon Gau’s basic design. Shah ’915 provided a direct motivation to replace the rubber in Gau’s balloon with polyurethane and to use a known two-half-section manufacturing method. Throne provided the specific manufacturing technique—vacuum thermoforming of multi-layer sheets—to efficiently create the half-sections with the necessary gas-barrier properties required for an intragastric balloon. The motivation was driven by improving material properties, known manufacturing advantages (less wrinkling), cost-effectiveness, and reduction of material waste.
    • Expectation of Success: Petitioner asserted a POSITA would have a high expectation of success. The combination involved applying known and compatible manufacturing techniques (Shah ’915’s welding and Throne’s thermoforming) to a known type of device (Gau’s gastric balloon) to achieve the predictable result of a more durable and cost-effective medical balloon.

Ground 2: Obviousness over Connors and Rakonjac - Claims 1-8 and 10-16 are obvious over Connors in view of Rakonjac.

  • Prior Art Relied Upon: Connors (Patent 6,976,950) and Rakonjac (Patent 5,316,605).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner contended that Connors taught nearly every element of the challenged claims. Connors disclosed a therapeutic method involving the introduction and inflation of a generally spherical, multi-layer balloon made from two bonded half-sections. The multi-layer wall explicitly comprised at least one gas barrier layer and other structural layers. The primary element Connors did not explicitly teach was manufacturing the half-sections using vacuum thermoforming. Rakonjac filled this gap by teaching that manufacturing inflatable three-dimensional shapes by vacuum forming two thin thermoplastic sheets and securing their edges was a well-known, "prior art development."
    • Motivation to Combine: A POSITA would combine Rakonjac’s method with Connors’s balloon design for reasons of efficiency and economy. Rakonjac’s vacuum thermoforming process was known to have a very short fabrication time, making it economical for producing thin-walled products. This presented a clear advantage over other, more time-consuming manufacturing methods suitable for multi-layer sheets discussed in Connors, such as dip molding or spray molding. Thus, a POSITA would be motivated to apply the conventional and efficient vacuum thermoforming process of Rakonjac to produce the multi-layer balloon half-sections described in Connors.
    • Expectation of Success: The combination would yield predictable results. Applying a standard, "old in the art" manufacturing process (Rakonjac) to fabricate a disclosed device structure (Connors) would have been a straightforward implementation for a POSITA with a reasonable expectation of successfully producing the claimed non-pillowed, multi-layer balloon.

  • Additional Grounds: Petitioner asserted an additional obviousness challenge for claim 6 based on Gau, Shah ’915, and Throne in view of Lai (Patent 4,739,758), which taught that gastric balloons with a diameter of 3 to 5 inches were known in the art.

4. Key Technical Contentions (Beyond Claim Construction)

  • Rebuttal of "Non-Pillowed" Balloon Manufacturing: The petition’s central technical contention countered the Patent Owner's declaration from prosecution, which had argued that vacuum thermoforming was the only method capable of producing a "non-pillowed" and spheroidal balloon from two peripherally bonded half-sections. Petitioner, supported by an expert declaration from Clair Strohl, argued this was incorrect. It contended that "pillowing" is a result of manufacturing defects (e.g., incorrect material selection or joining techniques), not an inevitable outcome of non-thermoforming methods. Petitioner asserted that other conventional methods disclosed in the prior art, such as dip molding, were fully capable of creating the claimed non-pillowed, spheroidal shape, a point it supported with evidence of a commissioned balloon made via dip molding.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-8 and 10-16 of the ’306 patent as unpatentable.