PTAB

IPR2018-01742

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

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 to reconstitute a medication dose. The method involves providing a device with sleeve members that slide axially, moving a piercing member from an inactivated position outside a receiving chamber to an activated position inside the chamber to establish fluid communication.

Prior Art Relied Upon: Honda (Patent 5,342,346).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Honda, which discloses a fluid container for aseptically mixing a dry drug and a solvent, teaches every limitation of independent claim 1 and dependent claims 4 and 7. Honda's device includes a connector with a double-pointed needle that is attached to a solvent container using a lock ring. Petitioner contended this lock ring meets the "fixedly attaching" limitation because it is "incapable of being removed" and must be broken to detach the container. Honda also allegedly teaches the sterilization step of claim 4 for aseptic use and the "hermetic seal" of claim 7 via a cap that seals the device.

Prior Art Relied Upon: Honda (Patent 5,342,346) and Forman (Patent 4,759,756).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner asserted that to the extent Honda does not teach every element of the claims, Forman supplies the missing features. Forman discloses a reconstitution device with securing means at both ends that "prevents inadvertent detachment." Specifically, Forman teaches a vial adapter with ridges that snap into the vial mouth to create a mechanical interlock, which Petitioner argued is a known way of achieving the "fixedly attaching" limitation of claim 1. Forman’s disclosure of manual connection by a pharmacist or nurse would have rendered claims 2 and 3 (manual vs. machine operation) obvious.
- Motivation to Combine: A POSITA would combine Honda and Forman because they are analogous art, both addressing drug reconstitution connectors. The ’192 patent itself acknowledged the problem of prior art connectors being too easily removed. A POSITA would have been motivated to modify Honda's device with the known, improved interlock attachment from Forman to solve this recognized problem.
- Expectation of Success: A POSITA would have a reasonable expectation of success because combining the known attachment mechanism of Forman with the device of Honda is a predictable substitution of one known component for another to achieve a known goal.

Prior Art Relied Upon: Gustavsson (Patent 4,564,054).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Gustavsson, which discloses a connector for transferring liquid medication between a syringe and a vial without air contamination, anticipates all limitations of claim 1. Gustavsson’s device includes a pair of telescoping parts, a piercing needle, and a receiving end that can be "snap fastened" onto a vial. This snap-fit connection allegedly meets the "fixedly attaching" limitation, as the connector part is designed to "remain on the ampoule" after use. The device also includes sliding members and a piercing needle that moves from an inactivated to an activated position, mapping to all key method steps of claim 1.
Additional Grounds: Petitioner asserted additional obviousness challenges, including combining Honda with Forman and Reynolds (Patent 5,364,369) to expressly teach manual or machine operation; combining Gustavsson with Reynolds for similar reasons; and combining Gustavsson with Honda to incorporate specific sterilization and sealing features.

"fixedly attaching": Petitioner argued this term was defined by the patentee as its own lexicographer in the specification. Based on the patent’s description, Petitioner proposed the construction "attached in a manner that prevents removal without breaking, detaching, or noticeably deforming part of the connector." This construction was central to Petitioner's arguments, as it was the key limitation added during prosecution to overcome a rejection and is allegedly met by the locking mechanisms in the prior art.
"hermetic seal": For this term in claim 7, Petitioner asserted it should be given its plain and ordinary meaning of an "airtight seal," which is consistent with its use throughout the patent specification.

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