PTAB

IPR2017-01586

Becton Dickinson Co v. B Braun Melsungen AG

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Method of Manufacturing a Catheter Insertion Device
  • Brief Description: The ’762 patent describes a method for manufacturing an over-the-needle catheter insertion device. The device is designed to accomplish two main objectives: (1) prevent blood outflow from the catheter after the needle is removed using a check valve, and (2) cover the needle tip upon withdrawal using a needle protective device to prevent accidental needlesticks.

3. Grounds for Unpatentability

Ground 1: Claims 18, 22, and 25 are obvious over Woehr in view of Tauschinski.

  • Prior Art Relied Upon: Woehr (Patent 6,117,108) and Tauschinski (Patent 4,387,879).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Woehr disclosed all elements of the challenged claims except for a valve and valve actuating element. Woehr taught a safety IV catheter with a catheter hub and a spring clip that functions as a “needle protective device” to prevent needlesticks. Tauschinski, in turn, taught a well-known self-sealing valve and valve actuator for use in catheters to prevent blood leakage. Petitioner asserted the spring clip in Woehr is the structure corresponding to the means-plus-function term "needle protective device." For dependent claims, Tauschinski was alleged to teach a hollow, cylindrical valve actuator with a frustoconical end (claim 22), and Woehr was alleged to teach a metallic, resilient spring clip (claim 25).
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine Woehr and Tauschinski to solve two well-known problems in catheter design with a single device. A POSITA would modify Woehr's safety catheter, which focused on needle protection, by incorporating Tauschinski's valve system to add the known benefit of preventing blood leakage upon needle withdrawal. This combination would predictably improve the overall safety and functionality of the device.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success because the combination involved integrating two known, compatible technologies (needle guards and sealing valves) to perform their respective, predictable functions within a standard catheter assembly.

Ground 2: Claims 18 and 22 are obvious over Van Heugten.

  • Prior Art Relied Upon: Van Heugten (Patent 5,053,014).

  • Core Argument for this Ground: This ground was presented as an alternative in the event the Board did not construe "needle protective device" as a means-plus-function term.

    • Prior Art Mapping: Petitioner contended that Van Heugten, by itself, disclosed every element of the method in claim 18. Van Heugten described a "Catheter with Controlled Valve" that included a catheter hub, a valve membrane for sealing, a "membrane opener" (valve actuating element) to permit fluid flow, and a needle guard that partially resides inside the catheter hub and is in-line with the other components. Petitioner argued Van Heugten’s disclosure of a generally cylindrical membrane opener with a nose-shaped opening means met the limitations of dependent claim 22.
    • Motivation to Combine (for §103 grounds): Not applicable as this is a single-reference ground. Petitioner argued all claimed steps and components were present in Van Heugten, making the claimed method obvious.

  • Additional Grounds: Petitioner asserted two additional grounds contingent on the Board's claim construction. Ground III argued claim 25 is obvious over Van Heugten in view of Lynn (WO 01/12249), where Lynn taught automating Van Heugten’s manual needle guard with a metallic retraction spring. Ground IV argued claim 22 is obvious over Van Heugten in view of Tauschinski, asserting a POSITA would modify Van Heugten's actuator with the specific frustoconical shape taught by Tauschinski to facilitate easier valve opening.

4. Key Claim Construction Positions

  • Petitioner dedicated a significant portion of its argument to construing the term “needle protective device” as a means-plus-function term under 35 U.S.C. §112, ¶ 6.
    • Petitioner argued that the term "device" is a nonce word devoid of structure, and the modifier "needle protective" only describes the term's function—to prevent unintended needlesticks.
    • Because the term allegedly failed to recite a sufficiently definite structure, Petitioner contended it should be construed to cover only the corresponding structure described in the ’762 patent's specification and its equivalents.
    • The structure identified in the specification for performing this function was a specific "spring clip" as shown in the patent's figures. This construction was critical to Petitioner’s primary ground, which combined Woehr’s similar spring clip with Tauschinski's valve.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and cancellation of claims 18, 22, and 25 of Patent 8,328,762 as unpatentable under 35 U.S.C. §103.