PTAB

IPR2017-00813

OBalon Therapeutics Inc v. Polyzen Inc

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1. Case Identification

2. Patent Overview

  • Title: Gastric Occlusive Device with Multilayer Polymeric Film
  • Brief Description: The ’491 patent discloses a gastric-occlusive device comprising a “non-pillowed” and spheroidal balloon for weight loss treatment. The balloon is formed from two vacuum-thermoformed half-sections of a multilayer film, which are bonded together at their peripheries to form a seam. The multilayer film includes a sealing layer with gas barrier properties laminated to at least one thermoplastic polymer layer that lacks such barrier properties.

3. Grounds for Unpatentability

Ground 1: Obviousness over Gau, Shah ’915, and Throne - Claims 1, 3-5, and 12-15 are obvious over Gau in view of 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, 1996).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the base invention was disclosed by Gau, which teaches a spheroidal, non-pillowed intragastric balloon with an inflation element for weight control. To improve upon Gau’s rubber-based balloon, a person of ordinary skill in the art (POSITA) would look to Shah ’915, which teaches manufacturing medical balloons from polyurethane film, a material recognized as superior to rubber. Shah ’915 also explicitly teaches forming balloons from two half-sections that are welded together. Throne addresses the manufacturing process, teaching the use of vacuum thermoforming to create multi-layer sheets where an expensive, thin gas-barrier layer is combined with a less expensive, durable polymer layer to create a cost-effective final product. The combination of these references allegedly teaches every limitation of the challenged claims.
    • Motivation to Combine: A POSITA would combine these references for predictable improvements. Shah ’915 provided an explicit motivation to replace rubber in medical devices like Gau's with superior polyurethane. Throne provided a well-understood economic motivation to use its multi-layer vacuum thermoforming method to create the necessary gas-barrier properties for the balloon in a cost-effective manner while reducing material waste. The combination was presented as a straightforward application of known manufacturing techniques to improve a known device.
    • Expectation of Success: Petitioner asserted a POSITA would have had a high expectation of success. The combination involved using known materials (polyurethane from Shah ’915) and a standard, cost-effective manufacturing process (multi-layer thermoforming from Throne) to produce a known device (the gastric balloon from Gau). Each element would perform its known function, leading to the predictable result of an improved gastric balloon.

Ground 2: Obviousness over Connors and Rakonjac - Claims 1-6, 10-18, 20, and 21 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 all elements of the challenged claims, including a therapeutic, spherical, multi-layer balloon made from two bonded half-sections. The multi-layer wall in Connors comprises at least one gas barrier layer and structural layers. The key element Connors did not explicitly teach was the use of vacuum thermoforming for manufacturing the balloon. Rakonjac was introduced to supply this missing element, as it expressly teaches that manufacturing inflatable three-dimensional shapes by vacuum forming two thermoplastic sheets and sealing their edges was a "prior art development" and "old in the art."
    • Motivation to Combine: A POSITA would be motivated to use the manufacturing method of Rakonjac to produce the balloon of Connors for reasons of efficiency and economy. Connors discusses several manufacturing methods, and Petitioner argued a POSITA would logically select vacuum thermoforming, a method described by Rakonjac as conventional, to reduce fabrication time and costs, particularly for producing thin-walled products in high volumes.
    • Expectation of Success: Success would have been expected because the combination merely involved applying a standard, well-known manufacturing process (vacuum thermoforming from Rakonjac) to create a product (the multi-layer balloon of Connors) suitable for that process. Rakonjac establishes that this technique was routine, making its application to the balloon half-sections in Connors a predictable and straightforward task for a POSITA.

4. Key Technical Contentions (Beyond Claim Construction)

  • "Non-Pillowed" Shape Feasibility: A central technical argument countered the Patent Owner's position during prosecution that a "non-pillowed" balloon could only be created using vacuum thermoforming. Petitioner, through the declaration of its expert Mr. Strohl, argued this was factually incorrect. The expert contended that other conventional methods taught in the prior art, such as dip molding mentioned in Connors, could produce spheroidal, non-pillowed balloons. The petitioner asserted that "pillowing" is not an inevitable result of other methods but rather a defect resulting from correctable errors in material selection, component shape, or joining technique.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-6, 10-18, 20, and 21 of the ’491 patent as unpatentable.