PTAB

IPR2018-00958

ReShape Medical LLC v. Fulfillium, Inc.

Log In

1. Case Identification

2. Patent Overview

  • Title: METHODS, DEVICES, AND SYSTEMS FOR OBESITY TREATMENT
  • Brief Description: The ’930 patent describes intragastric devices for obesity treatment. The technology centers on a gastric implant with an expandable scaffold and a plurality of inflatable compartments, designed to occupy space in the gastric cavity to induce satiety. A key feature is that the device's expanded shape is configured to be too large to pass the pylorus, even if a single compartment deflates, thereby preventing accidental passage.

3. Grounds for Unpatentability

Ground 1: Obviousness over Bangs and Foster - Claims 1-30 are obvious over Bangs and Foster, further in view of Lai and either Jambor or Gottschalk.

  • Prior Art Relied Upon: Bangs (Patent 5,234,454), Foster (Patent 4,485,805), Lai (Patent 4,739,758), Jambor (Application # US2005/0070937), and Gottschalk (Patent 3,570,494).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the primary combination of Bangs and Foster teaches the core elements of the challenged claims. Bangs disclosed a percutaneous intragastric catheter with two separately inflatable balloons on an elongated shaft for weight loss. Foster disclosed a free-floating, single-chamber intragastric balloon designed to conform to the kidney shape of the stomach, reducing trauma. The combination of these references, Petitioner asserted, would result in a free-floating, dual-balloon device that conforms to the stomach and prevents passage through the pyloric valve upon a single balloon failure, thus meeting the limitations of independent claims 1, 12, and 19. The secondary references were used to supply remaining features: Lai taught determining fill volume via X-ray and using surface projections to reduce ulceration, while Jambor and Gottschalk taught using a series of one-way valves on a single inflation lumen.
    • Motivation to Combine: A person of ordinary skill in the art (POSITA) would combine Bangs and Foster to gain the benefits of both: the safety of Bangs’ dual-balloon design (preventing passage on partial deflation) and the reduced trauma and improved conformity of Foster’s free-floating, kidney-shaped design. A POSITA would further incorporate the valve system from Jambor or Gottschalk to replace the multiple lumens in Bangs, thereby reducing the device's stiffness and diameter, which was a known design challenge. The teachings of Lai would be incorporated for the known benefits of ulceration prevention and proper sizing.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success in combining these known elements from the prior art to achieve their predictable functions.

Ground 2: Obviousness over Lointier and Burnett - Claims 1-30 are obvious over Lointier and Burnett, further in view of Lai and either Jambor or Gottschalk.

  • Prior Art Relied Upon: Lointier (WO 03/055420), Burnett (Application # US2005/0033331), Lai (Patent 4,739,758), Jambor (Application # US2005/0070937), and Gottschalk (Patent 3,570,494).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner contended that Lointier taught an expandable intragastric balloon with multiple, adjacent, flexible pouches that could be filled independently. Burnett taught an intragastric device with two balloons spaced apart on a shaft, dimensioned to prevent the device from passing through the pyloric valve. Petitioner argued that combining these references would result in a multi-pouch device (from Lointier) with spaced-apart pouches (as in Burnett) that would not pass the pyloric valve if one pouch deflated. This combination allegedly taught the key features of the independent claims. As in Ground 1, Lai was cited for features reducing ulceration and for determining fill volume, while Jambor and Gottschalk were cited for a more efficient single-lumen, serial-valve inflation system.
    • Motivation to Combine: A POSITA would be motivated to modify Lointier's device by spacing the pouches apart, as taught by Burnett, to reduce the risk of the device passing through the pyloric valve, a known safety concern. Using the common connection means of Lointier with the spaced-apart construction of Burnett would also allow the device to conform more closely to the kidney-shape of the gastric cavity, maximizing volume displacement and reducing ulceration risk. The motivation to incorporate the secondary references was identical to Ground 1: to simplify the inflation mechanism and add known safety and sizing features.
    • Expectation of Success: The combination was presented as a predictable integration of known technologies to solve known problems in the field of bariatric devices.

  • Additional Grounds: Petitioner asserted an additional obviousness challenge (Ground 3) against claims 1-30 based on the combination of Lointier and Foster, further in view of Lai, Jambor, or Gottschalk. This ground relied on a similar design modification theory, arguing a POSITA would have been motivated to configure the multiple pouches of Lointier to assume the gastric-conforming, kidney-shape taught by Foster to more effectively approximate the stomach volume.

4. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1-30 of the ’930 patent as unpatentable under 35 U.S.C. §103.