Becton Dickinson Co v. Baxter Intl Inc

1. Case Identification

• Case #: IPR2018-01742
• Patent #: 6,159,192
• Filed: September 17, 2018
• Petitioner(s): Becton, Dickinson and Company
• Patent Owner(s): Baxter International, Inc.
• Challenged Claims: 1-7

2. Patent Overview

• Title: Sliding Reconstitution Device with Seal
• Brief Description: The ’192 patent is directed to a method for connecting a reconstitution device to a drug container. The device includes a piercing member and sliding sleeve members that allow it to be attached to a container in an inactivated state and later activated to establish fluid communication.

3. Grounds for Unpatentability

Ground 1: Anticipation - Claims 1, 4, and 7 are anticipated by Honda under 35 U.S.C. §102(b)

• Prior Art Relied Upon: Honda (5,342,346).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Honda, which discloses a fluid container for mixing a dry drug and a solvent, teaches every element of independent claim 1 and dependent claims 4 and 7. The central argument focused on the "fixedly attaching" limitation. Petitioner asserted that Honda's use of a lock ring (7) on its guide capsule (4) meets this limitation, as the lock ring is designed with a weakened part that must be broken to remove the capsule from the solvent container. This mechanism prevents accidental disengagement, aligning with the ’192 patent's definition of "fixedly attaching." Petitioner further mapped Honda's sliding vial guide and guide capsule to the claimed "first and second sleeve members" and its teachings of aseptic mixing to the "sterilizing" step of claim 4.

Ground 2: Obviousness - Claims 1-7 are obvious over Honda in view of Forman

• Prior Art Relied Upon: Honda (Patent 5,342,346) and Forman (4,759,756).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner contended that to the extent Honda does not teach every limitation, the combination with Forman renders the claims obvious. Forman discloses a reconstitution device with securing means, such as a vial adapter with ridges that snap into a vial mount, to create a permanent, interlocking connection that prevents inadvertent detachment. This, Petitioner argued, explicitly teaches the "fixedly attaching" limitation. A person of ordinary skill in the art (POSITA) would have looked to Forman's well-known solution for permanently coupling a connector to a vial to improve the functionality of the device disclosed in Honda.
  • Motivation to Combine: Petitioner asserted several motivations. Both Honda and Forman are in the analogous art of connector devices for drug reconstitution. A POSITA would have been motivated to modify Honda's device with Forman's superior vial attachment mechanism to solve the known problem of connectors being too easily removed, a problem the ’192 patent itself purports to solve. Combining these known elements would have yielded predictable results.
  • Expectation of Success: A POSITA would have had a high expectation of success in combining the references, as it involved the simple substitution of one known container attachment mechanism (Forman's) for another (Honda's) to achieve a more secure connection.

Ground 3: Anticipation - Claim 1 is anticipated by Gustavsson under 35 U.S.C. §102(b)

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

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner argued that Gustavsson, which discloses a connector for transferring liquid medication between vessels, independently anticipates claim 1. Gustavsson teaches a connector with two members, where the second member (20) is designed to "be snap fastened on an ampoule" (container). After use, this second member is "allowed to remain on the ampoule" and is thrown away with it, demonstrating a fixed attachment. Petitioner asserted this snap-fit mechanism, which is not intended for removal, satisfies the "fixedly attaching" limitation. Gustavsson also discloses telescoping parts (33, 34) that slide axially and house a needle (16), which moves from an inactivated position to an activated position to pierce a membrane, directly mapping to the sliding sleeve and piercing member limitations of claim 1.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including claims 1-7 as obvious over Honda alone; claims 2-3 as obvious over Honda, Forman, and Reynolds; and various claims as obvious over combinations of Gustavsson, Reynolds, and Honda, all relying on similar principles of combining known elements from analogous art.

4. Key Claim Construction Positions

• "fixedly attaching": This term was identified as the heart of the alleged invention, added during prosecution to overcome a rejection. Petitioner argued the patentee acted as its own lexicographer, defining the term in the specification to mean attached "such that it cannot be detached without using a force considerably in excess of that normally used to operate the device. Such a force likely would break, detach or noticeably deform one or more...portions of the connector." Petitioner contended this construction was critical and that the prior art met this specific definition.
• "hermetic seal": For claim 7, Petitioner argued this term should be given its plain and ordinary meaning of an "airtight seal," consistent with its use in the patent.

5. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1-7 of the ’192 patent as unpatentable.