PTAB

IPR2018-01741

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 ’237 patent is directed to a connector device for establishing fluid communication between two containers, such as a vial containing a powdered drug and a container with a diluent, to allow for drug reconstitution. The device uses telescoping sleeve members to facilitate the connection.

3. Grounds for Unpatentability

Ground 1: Claims 1-4 and 15-16 are anticipated by 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 element of independent claim 1. Uchida’s "capsule 4" corresponds to the claimed "first sleeve member," its "auxiliary sliding cover 5" is the "second sleeve member," and its "double-pointed cannula" is the "piercing member." Petitioner asserted that the "means for preventing... disassociation" is met by Uchida's annular rib 45, which retains the sliding cover, or its stopper means (undercut 47), which locks the sliding member. Dependent claims 2-4 and 15-16 were also allegedly disclosed, with Uchida’s rubber plug 22 and rubber cap 6 meeting the sealing limitations.

Ground 2: Claims 7-14 are obvious 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 to arrive at the limitations of claims 7-14, which relate to a "bushing." Petitioner contended that van de Veerdonk's "outer telescopic member 25" with its "cam 32" forms an interference fit with the inner member, corresponding to the claimed "bushing" (as construed by Petitioner). This structure in van de Veerdonk is attached to a rubber stopper (a barrier material) and includes an annular ridge (cam 32) and a sheath-like structure (guide element 30), allegedly teaching the specific features of claims 7, 9, and 10.
    • Motivation to Combine: Petitioner argued a POSITA would combine these references because they are analogous art, both disclosing telescoping connectors for drug reconstitution. A POSITA seeking to improve the vial attachment of Uchida's device would have looked to known solutions like the interference-fit mechanism in van de Veerdonk to solve the known problem of inadvertent disassembly.
    • Expectation of Success: A POSITA would have a reasonable expectation of success as both devices use similar telescoping structures and piercing needles, making the incorporation of van de Veerdonk's attachment features into Uchida's system a predictable modification.

Ground 3: Claims 1 and 15 are anticipated by 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 independent claim 1 and dependent claim 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 "means for preventing... disassociation" was allegedly met by Gustavsson’s "stop lugs 35," which prevent the two telescoping parts from separating. The "piercing member" is needle 16. For claim 15, Petitioner argued that the shelf on telescoping member 33 acts as a "stop at the first end of the first sleeve member."

Ground 4: Claims 17 and 18 are obvious over Uchida in view of Forman.

  • Prior Art Relied Upon: Uchida (Patent 5,445,631) and Forman (Patent 4,759,756).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground asserted that combining Uchida with Forman would have rendered claims 17 and 18 obvious. These claims add a "plurality of tabs extending inwardly and downwardly" to attach to a container. Petitioner argued Forman discloses this feature in its vial adapter 76, which uses inwardly extending ridges 96 that snap into the underside of a vial mouth to create a mechanical interlock. Claim 18’s limitation of a "sharpened distal end" was also allegedly taught by Forman.
    • Motivation to Combine: Petitioner argued a POSITA would have been motivated to incorporate Forman’s vial attachment mechanism into Uchida’s device to solve the known problem of connectors being too easily removed from vials, a deficiency explicitly noted in the ’237 patent’s background.
    • Expectation of Success: Because both references are in the same field of drug reconstitution connectors, a POSITA would have expected success in substituting Forman’s well-known vial adapter for Uchida’s attachment means to achieve a more secure connection.

  • Additional Grounds: Petitioner asserted additional anticipation and obviousness challenges, including obviousness of claims 1-4 and 15-16 over Uchida alone; obviousness of claims 1, 15-18 over Gustavsson alone; obviousness of claims 2-4, 7-11, and 15-16 over Gustavsson in view of van de Veerdonk; obviousness of claims 12-14 over Gustavsson, van de Veerdonk, and Uchida; and obviousness of claims 17-18 over Gustavsson in view of Forman.

4. Key Claim Construction Positions

Petitioner advanced several claim constructions as central to its arguments, contending the patentee acted as its own lexicographer for certain terms.

  • "Means for... Preventing the First Sleeve Member from Becoming Disassociated...": Petitioner argued this is a means-plus-function term where the function is preventing sleeve separation. The corresponding structure disclosed in the ’237 patent was asserted to be "a radially-symmetric stop, such as a sleeve, ring, or washer."
  • "Means for Hermetically Sealing...": Petitioner argued the two means-plus-function terms for hermetically sealing the sleeve end and the piercing member correspond to structures disclosed in the specification: for the sleeve, "a barrier... made from a polymeric material, aluminum foil, spun paper, or an induction weld," and for the piercing member, "a flexible elastomeric sheath."
  • "Bushing": Petitioner argued that the ’237 patent uses "bushing" inconsistently with its ordinary meaning. Based on the specification, Petitioner proposed the term should be construed as "a cylindrical component that attaches to an opening in another component by forming an interference fit," rather than a simple lining. This construction was critical for mapping prior art like van de Veerdonk to claims 7-14.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1-4 and 7-18 of the ’237 patent as unpatentable.