PTAB

IPR2017-01590

Becton, Dickinson and Company v. B. Braun Melsungen AG

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1. Case Identification

2. Patent Overview

  • Title: Over-the-Needle Catheter Assembly
  • Brief Description: The ’641 patent discloses an over-the-needle catheter insertion device. The device is designed to accomplish two primary objectives known in the art: (1) covering the needle tip with a protector immediately after use to prevent accidental needlesticks, and (2) incorporating a valve to minimize blood exposure after the needle is withdrawn from the catheter hub.

3. Grounds for Unpatentability

Ground I: Claims 15, 17, 18, 20, and 22 are obvious over Woehr in view of Callaway.

  • Prior Art Relied Upon: Woehr (WO 2004/004819) and Callaway (Application # 2006/0178635).
  • Core Argument:
    • Prior Art Mapping: Petitioner argued that Woehr discloses a catheter insertion device that teaches nearly every element of independent claim 15. Specifically, Woehr shows a safety catheter assembly with a catheter hub, a needle hub with a needle, a check valve to limit fluid flow, and a valve opener. Woehr also discloses a safety device in the form of a spring clip that covers the needle tip upon withdrawal. The petition contended, however, that Woehr fails to disclose the claimed "tip protector housing" for this safety device. Callaway was asserted to supply this missing element, as it discloses an "Easy Entry Catheter" with a "middle hub" that explicitly functions as a housing for a nearly identical metal spring clip safety device. Petitioner noted that the spring clip disclosed in Woehr and the one incorporated by reference into Callaway are structurally the same.
    • Motivation to Combine: A POSITA would combine Woehr and Callaway to improve the safety and reliability of the Woehr device. The petition argued that adding Callaway’s housing to Woehr’s assembly would provide more secure protection from the needle tip. This addition would reduce the likelihood of inadvertently activating the needle guard or pulling it loose from the catheter hub, a known benefit of using a shroud or housing. Further motivation would stem from the desire to prevent unintended contact with any fluids remaining on the needle after it is removed.
    • Expectation of Success: A POSITA would have a high expectation of success in this combination. The argument was that this modification involved incorporating a known feature (a housing for a safety clip) from a similar catheter device to achieve the predictable and well-understood benefits of improved safety and containment.

Ground II: Claims 15, 17, 18, 20, and 22 are obvious over Woehr in view of Villa.

  • Prior Art Relied Upon: Woehr (WO 2004/004819) and Villa (Application # 2004/0225260).
  • Core Argument:
    • Prior Art Mapping: This ground presented a parallel obviousness argument, again using Woehr as the primary reference for the base catheter assembly and its spring clip safety device. The petition asserted that Villa teaches the missing "tip protector housing" limitation. Villa discloses a "protective device for a needle" comprising a hollow body or housing that surrounds an internal safety mechanism (elastic blocking arms) and is designed to be coupled to the catheter hub as an "extension piece."
    • Motivation to Combine: A POSITA would be motivated to modify Woehr’s device by placing its safety clip within a housing like that taught by Villa. The petition asserted that Villa’s housing offers several known advantages over Woehr’s unenclosed spring clip, including being more compact, easier to construct, and significantly better at containing fluids retained on the needle. This would address a shortcoming in Woehr, where fluids on the exposed needle could expose operators to risk. Therefore, a POSITA would integrate the housing to achieve the predictable result of minimizing blood exposure and needlestick risks.
    • Expectation of Success: The combination was presented as a straightforward integration of known components. A POSITA would expect the Woehr spring clip to function as intended within the protective environment of the Villa housing, leading to a more robust and safer overall device with predictable results.

4. Key Claim Construction Positions

  • The petition argued that the claim term "safety device" is indefinite and should be construed as a means-plus-function term under 35 U.S.C. §112 (pre-AIA §112, ¶ 6).
  • Petitioner contended that "device" is a generic nonce word that fails to recite any definite structure. It argued the modifier "safety" is purely functional, describing the purpose of the device (preventing accidental needlesticks) rather than its structural characteristics.
  • The petition further argued that the additional claim language requiring the "safety device" to comprise a "tip protector housing" does not provide sufficient structure to perform the claimed function of "covering the needle tip." Citing the patent’s specification, Petitioner asserted the housing merely "accommodates" or "surrounds" the tip protector, while the tip protector itself is the structure that actually performs the covering function.
  • Consequently, Petitioner identified the corresponding structure in the ’641 patent’s specification as the various tip protectors themselves (e.g., spring clips), not the housing. This construction was central to the obviousness arguments, as it permitted mapping Woehr's spring clip directly onto the "safety device" limitation, leaving only the housing to be supplied by a secondary reference.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 15, 17, 18, 20, and 22 of the ’641 patent as unpatentable under 35 U.S.C. §103.