PTAB

IPR2018-01741

Becton Dickinson Co v. Baxter Intl Inc

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Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Sliding Reconstitution Device with Seal
  • Brief Description: The ’237 patent discloses a connector device for establishing fluid communication between two containers, such as for reconstituting a drug dose. The device uses two telescoping sleeve members, a piercing member, and a means to prevent the sleeves from disassociating.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-4 and 15-16 under §102 over Uchida

  • Prior Art Relied Upon: Uchida (Patent 5,445,631).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Uchida, which discloses a fluid delivery system for mixing a drug, teaches every limitation of independent claim 1. Uchida’s cylindrical “capsule 4” was mapped to the claimed “first sleeve member,” and its “auxiliary sliding cover 5” was mapped to the “second sleeve member.” Petitioner asserted that Uchida’s internal annular rib and stopper means, which engage to prevent unintentional separation, meet the claimed “means positioned on the first sleeve member for preventing… disassociation.” Dependent claims 2-4, relating to hermetic seals, were allegedly disclosed by Uchida’s pierceable rubber plugs and caps.

Ground 2: Obviousness of Claims 7-14 under §103 over Uchida in view of van de Veerdonk

  • Prior Art Relied Upon: Uchida (Patent 5,445,631) and van de Veerdonk (Patent 3,995,630).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built upon the teachings of Uchida by incorporating features from van de Veerdonk, which discloses a pre-loaded syringe with a telescopic assembly. Petitioner argued that the limitations of dependent claims 7-14, which recite a "bushing," were taught by van de Veerdonk. Specifically, van de Veerdonk’s "outer telescopic member 25" with its "cam 32" that forms an interference fit was argued to be a "bushing" as that term is defined in the ’237 patent. The structure in van de Veerdonk was also argued to teach the claimed sheath, annular ridges, and interference fit recited in further dependent claims.
    • Motivation to Combine: Petitioner contended a POSITA would combine Uchida and van de Veerdonk because they are analogous art, both disclosing connector devices for reconstituting drugs. A POSITA seeking to solve known problems of vial attachment and device disassembly, acknowledged in the ’237 patent, would look to devices like van de Veerdonk for known solutions and incorporate its robust attachment and stop mechanisms into Uchida’s design.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success because both references disclose similar telescoping connectors that establish fluid connection via a piercing member, making the integration of their respective features straightforward and predictable.

Ground 3: Anticipation of Claims 1 and 15 under §102 over Gustavsson

  • Prior Art Relied Upon: Gustavsson (Patent 4,564,054).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued that Gustavsson, which discloses a fluid transfer system, anticipates claims 1 and 15. Gustavsson’s “outer telescoping part 33” was mapped to the “first sleeve member” and its “inner telescoping part 34” to the “second sleeve member.” The claimed “means for preventing… disassociation” was allegedly met by Gustavsson’s “stop lugs 35,” which prevent the two telescoping parts from separating. Petitioner asserted that the stop required by claim 15 was disclosed as a shelf at the first end of Gustavsson’s telescoping member 33.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including:

    • Claims 1-4 and 15-16 as obvious over Uchida alone.
    • Claims 17-18 as obvious over Uchida in view of Forman (Patent 4,759,756).
    • Claims 1, 15-18 as obvious over Gustavsson alone.
    • Claims 2-4, 7-11, and 15-16 as obvious over Gustavsson in view of van de Veerdonk.
    • Claims 12-14 as obvious over Gustavsson in view of van de Veerdonk and Uchida.
    • Claims 17-18 as obvious over Gustavsson in view of Forman.

4. Key Claim Construction Positions

  • "Means for... Preventing the First Sleeve Member from Becoming Disassociated...": Petitioner argued this is a means-plus-function term governed by pre-AIA §112, paragraph 6. The corresponding structure disclosed in the ’237 specification was identified as “a radially-symmetric stop, such as a sleeve, ring, or washer.”
  • "Bushing": Petitioner contended that the patentee acted as its own lexicographer to redefine this term. While the ordinary meaning of "bushing" is a lining fitted to the inside of an opening, the ’237 patent describes a component fitted to the outside of a cylindrical sleeve. Therefore, Petitioner proposed construing "bushing" as “a cylindrical component that attaches to an opening in another component by forming an interference fit.” This construction was central to mapping prior art like van de Veerdonk, which discloses an outer member with an interference fit cam.

5. Relief Requested

  • Petitioner requests institution of an IPR trial and cancellation of claims 1-4 and 7-18 of the ’237 patent as unpatentable.