Becton Dickinson Co v. Baxter Intl Inc

1. Case Identification

• Case #: IPR2018-01744
• Patent #: 6,852,103
• Filed: September 17, 2018
• Petitioner(s): Becton, Dickinson and Company
• Patent Owner(s): Baxter International, Inc.
• Challenged Claims: 1, 11, 14, 15, 17, 19-28, and 30

2. Patent Overview

• Title: Sliding Reconstitution Device with Seal
• Brief Description: The ’103 patent discloses a connector device for establishing fluid communication between two containers, such as a fluid bag and a drug vial. The device uses telescoping sleeve members to facilitate the connection and reconstitution of a drug.

3. Grounds for Unpatentability

Ground 1: Obviousness over Gustavsson and Lynn - 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 argued that Gustavsson taught the core structure of the claimed invention: a fluid transfer device with a pair of telescoping sleeves (an inner part and an outer part) and a piercing member (needle) for connecting two containers. However, Gustavsson lacked a visual indicator for activation. Petitioner asserted that Lynn, an analogous intravenous line coupling device, explicitly taught using a bright color on an inner tube that becomes visible when an outer tube is rotated to a locked position, thereby providing a clear visual indication of the device's status. The combination of Gustavsson's structure with Lynn's visual indicator rendered the "means for visually indicating" limitation of claim 1 obvious.
  • Motivation to Combine: A POSITA would combine these references because they are analogous art, both disclosing telescoping connectors for medical fluid transfer. Petitioner argued that known deficiencies in prior art devices included a lack of visual indication of activation, a problem Lynn directly solved. A POSITA would therefore have been motivated to incorporate Lynn's well-known color indication solution into Gustavsson’s device to improve its usability and safety.
  • Expectation of Success: A POSITA would have a high expectation of success, as the combination involved applying a simple color indicator from one telescoping medical device to another, a predictable modification using known methods.

Ground 2: Obviousness over Gustavsson, Lynn, and Dudar - Claims 22-28 and 30 are obvious over Gustavsson in view of Lynn and Dudar.

• Prior Art Relied Upon: Gustavsson (Patent 4,564,054), Lynn (Patent 4,946,445), and Dudar (Patent 5,100,394).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground built upon the combination of Gustavsson and Lynn to address dependent claims reciting specific vial-engaging features. Petitioner contended that Dudar, which disclosed an injection site coupling system, taught the limitations of claims 22-28 and 30, including a vial adapter with "a plurality of circumferentially spaced and axially extending segmented fingers" for engaging a container. Dudar showed how slots could create such fingers and how features like bumps, undercuts, and tabs could be used to securely grip a vial.
  • Motivation to Combine: A POSITA seeking to improve the vial attachment mechanism of the Gustavsson device would have looked to other fluid transfer devices like Dudar. Petitioner argued that substituting Gustavsson's bayonet coupling with Dudar's more robust segmented finger attachment mechanism was a predictable design choice to create a more secure connection to standard drug vials.
  • Expectation of Success: Success was expected because Dudar provided a detailed blueprint for a vial attachment mechanism that could be readily integrated into the base connector taught by Gustavsson, representing a combination of known components for their intended purposes.

Ground 3: Obviousness over Zdeb and Lynn - 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: This ground presented an alternative to Gustavsson. Petitioner argued that Zdeb, like Gustavsson, taught a sliding reconstitution device with all major structural elements of claim 1 except for the color-based visual indicator. Zdeb disclosed a first inner sleeve and a second outer sleeve that move axially relative to each other, along with a piercing member to establish fluid communication between a bag and a vial. As in Ground 1, Lynn was cited for its teaching of a visual color indicator to show when a telescoping medical connector is in a locked or activated state.
  • Motivation to Combine: The motivation was identical to that in Ground 1. Petitioner asserted that Zdeb's device suffered from the same deficiency as other prior art: a lack of clear visual indication of its activation state. A POSITA would have been motivated to incorporate the known solution from Lynn into Zdeb's device to solve this well-understood problem.
  • Expectation of Success: The combination was a predictable integration of a known feature (color indicator) into a known device type (telescoping connector) to achieve an expected improvement in usability.
• Additional Grounds: Petitioner asserted additional obviousness challenges based on Gustavsson in combination with Lynn and van de Veerdonk (for claims 19-21), and on Zdeb in combination with Lynn and either van de Veerdonk or Dudar for various dependent claims, all relying on similar design substitution or modification rationales.

4. Key Claim Construction Positions

• "Means for visually indicating...": Petitioner argued this term in claim 1 was not a means-plus-function element because the claim itself recited the structure for performing the function (a color indication using two different colored sleeve members where one color is obscured in the activated position).
• "Bushing": Petitioner contended that the patentee acted as its own lexicographer. While a bushing is typically a removable lining for an opening, the ’103 patent described the "bushing" as a component fitted to the outside of a cylindrical sleeve. Petitioner thus proposed construing the term as "a cylindrical component that attaches to an opening in another component by forming an interference fit."
• "Standing Ribs": Petitioner argued this was a unique phrase coined by the patentee and should be construed based on the specification's description as "elongated, axially extending structures that indent the metal crimp of a vial to inhibit its movement."

5. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1, 11, 14, 15, 17, 19-28, and 30 of the ’103 patent as unpatentable.