PTAB

IPR2018-01744

Becton, Dickinson and Company v. Baxter International, Inc.

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1. Case Identification

2. Patent Overview

  • Title: Sliding Reconstitution Device with Seal
  • Brief Description: The ’103 patent describes a connector device for establishing fluid communication between two containers, such as a vial and a syringe. The device uses telescoping sleeves and is primarily intended for reconstituting a drug dose prior to administration.

3. Grounds for Unpatentability

Ground 1: Claims 1, 11, 14, 15, 17, and 19 are obvious over Gustavsson in view of Lynn.

  • Prior Art Relied Upon: Gustavsson (Patent 4,564,054) and Lynn (Patent 4,946,445).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Gustavsson taught the core structure of the claimed invention, including a connector with two telescoping sleeve members and a piercing member for establishing fluid communication between two containers. However, Gustavsson lacked a visual indicator for activation. Lynn, an intravenous line coupling device, was alleged to supply this missing element by teaching the use of a bright color on an inner tube that becomes visible when the device is moved to a locked, or activated, position.
    • Motivation to Combine: Petitioner argued that Gustavsson and Lynn are analogous art, as both disclose fluid transfer devices for medical applications. A person of ordinary skill in the art (POSITA) would be motivated to combine Lynn's visual indicator with Gustavsson’s device to solve the known problem of lacking a clear indication of activation. This deficiency was a known issue in similar prior art devices.
    • Expectation of Success: A POSITA would have a reasonable expectation of success because both references use telescoping connectors, and incorporating a color indicator is a simple modification that would yield predictable results.

Ground 2: Claims 19-21 are obvious over Gustavsson in view of Lynn and van de Veerdonk.

  • Prior Art Relied Upon: Gustavsson (Patent 4,564,054), Lynn (Patent 4,946,445), and van de Veerdonk (Patent 3,995,630).
  • Core Argument for this Ground:
    • Prior art Mapping: This ground builds upon Ground 1, adding van de Veerdonk to address limitations in claims 19-21 related to preventing the sleeve members from disassociating. Petitioner contended that Gustavsson and Lynn teach the base combination, while van de Veerdonk discloses specific structures for this purpose. Van de Veerdonk, which describes a pre-loaded syringe with a telescopic assembly, was asserted to teach the use of multiple ridges, grooves, flanges, and a cam that act as stops to prevent the disassembly of telescoping cylinders. These structures correspond to the "means for preventing... disassociation" and the "bushing" recited in claims 19-21.
    • Motivation to Combine: A POSITA, seeking to improve the Gustavsson/Lynn device, would be motivated to look to analogous art like van de Veerdonk to solve the known problem of inadvertent disassembly during activation.
    • Expectation of Success: The combination was asserted to be predictable, as it involved incorporating known mechanical stop features into an existing device to enhance its reliability.

Ground 4: Claims 1, 11, 14, 15, and 17 are obvious over Zdeb in view of Lynn.

  • Prior Art Relied Upon: Zdeb (Patent 4,898,209) and Lynn (Patent 4,946,445).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner presented Zdeb as an alternative primary reference to Gustavsson. Zdeb, which was cited during the prosecution of the ’103 patent, teaches a coupling device with two telescoping sleeves and a piercing member for reconstituting a drug. Petitioner argued Zdeb taught every element of the independent claims except for the "means for visually indicating" activation. As in Ground 1, Lynn was combined to supply this visual color indication feature.
    • Motivation to Combine: Petitioner emphasized that the prosecution history of the ’103 patent family shows the invention was positioned as a minor improvement over Zdeb, with the key distinguishing feature being the visual indicator. A POSITA aware of the lack of a visual indicator in Zdeb would be motivated to incorporate the known solution from Lynn.
    • Expectation of Success: A POSITA would expect success in combining the known visual indication technology of Lynn with the well-understood connector structure of Zdeb.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including combinations of Gustavsson, Lynn, and Dudar (Patent 5,100,394) and combinations based on Zdeb with Lynn, van de Veerdonk, and/or Dudar. These grounds relied on similar rationales, adding Dudar for its teachings on specific vial attachment mechanisms (e.g., segmented fingers, standing ribs) and van de Veerdonk for its teachings on preventing sleeve disassociation.

4. Key Claim Construction Positions

  • "Means for Visually Indicating that the Connector is in the Activated Position": Petitioner argued this term, despite using "means for" language, is not a means-plus-function limitation under pre-AIA §112, paragraph 6. The rationale was that the claim itself recites sufficient structure to perform the function—namely, "a color indication wherein one of the sleeve members has a first color, the other sleeve member has a second color, wherein only one color is visible when the connector is in the activated position."
  • "Bushing" (claims 20-21): Petitioner contended that the patentee acted as their own lexicographer, defining "bushing" in a manner inconsistent with its ordinary dictionary meaning (a lining). Based on the specification's description, Petitioner proposed construing "bushing" as "a cylindrical component that attaches to an opening in another component by forming an interference fit."
  • "Standing Ribs" and "Gusset" (claims 26-30): Petitioner argued these are unique phrases coined in the ’103 patent. Accordingly, they should be construed based on their specific descriptions in the specification rather than any ordinary meaning. "Standing ribs" was construed as "elongated, axially extending structures that indent the metal crimp of a vial to inhibit its movement."

5. Relief Requested

  • Petitioner requested institution of IPR and cancellation of claims 1, 11, 14, 15, 17, 19-28, and 30 of Patent 6,852,103 as unpatentable.