PTAB

IPR2017-01588

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

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1. Case Identification

2. Patent Overview

  • Title: Safety Catheter Assembly
  • Brief Description: The ’247 patent describes an over-the-needle safety catheter assembly designed to prevent accidental needlesticks and minimize blood exposure after use. The invention combines a needle protective device (tip protector) that automatically covers the needle tip upon withdrawal, a valve within the catheter hub that seals to prevent blood leakage, and a valve actuating element that can open the valve for fluid infusion.

3. Grounds for Unpatentability

Ground I: Claims 12, 13, 20-23, and 29 are obvious over Woehr in view of Callaway.

  • Prior Art Relied Upon: Woehr (WO 2004/004819) and Callaway (Application # 2006/0178635).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Woehr, a publication by one of the named inventors of the ’247 patent, discloses a safety catheter assembly with nearly all the claimed features. This includes a first hub, a needle, a valve to prevent blood flow, a valve actuating element, and a needle protective device (a spring clip). However, Petitioner contended Woehr lacks a claimed "third hub" that houses the protective device and features an "arm" for securement. Callaway was asserted to supply this missing element, as it teaches a safety catheter with a three-hub design, including a middle hub that houses a similar spring clip protector and has a projecting portion (the claimed "arm") that fits into the catheter hub to prevent unintentional separation.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine Woehr and Callaway to improve the safety and security of Woehr's device. Woehr’s unprotected spring clip could be snagged, whereas Callaway teaches that enclosing the clip within a dedicated hub protects users and provides a more robust, secure design. A POSITA would have recognized the benefit of adding Callaway's protective housing to Woehr's functional but less secure assembly.
    • Expectation of Success: The combination was presented as predictable, as it involved incorporating a known type of housing (from Callaway) with a known type of safety clip (taught by both Woehr and Callaway). No unexpected results would arise from placing Woehr’s clip inside Callaway’s housing.

Ground II: Claims 12, 13, 20-23, and 29 are obvious over Woehr in view of Villa.

  • Prior Art Relied Upon: Woehr (WO 2004/004819) and Villa (Application # 2004/0225260).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground presented an alternative to Callaway for supplying the missing third hub. As in Ground I, Woehr provided the foundational safety catheter device. Villa was asserted to teach a protective device for a catheter needle that includes a hollow body, or housing (the claimed "third hub"), which surrounds the safety mechanism. This housing in Villa is formed as an extension piece that couples to the catheter hub and includes a projecting portion (the claimed "arm").
    • Motivation to Combine: A POSITA would have been motivated to modify Woehr by incorporating its spring clip into a housing like the one taught by Villa. Villa explicitly describes its housing as providing advantages over a bare safety mechanism, including reducing the risk of contact with patient fluids on the needle. This provides a clear reason to add Villa's housing to Woehr's device to predictably minimize blood exposure risks and enhance operator safety.
    • Expectation of Success: The combination would have yielded predictable results. It involved placing a known safety clip (from Woehr) inside a known type of protective housing (from Villa) to achieve the known benefits of both components.

Ground III: Claims 12, 13, 20-23, and 29 are obvious over Woehr in view of Callaway and further in view of Sutton.

  • Prior Art Relied Upon: Woehr (WO 2004/004819), Callaway (Application # 2006/0178635), and Sutton (Application # 2007/0038186).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground builds upon the combination of Woehr and Callaway by introducing Sutton to further teach or modify the claimed "arm." Sutton discloses a needle guard with "duckbill" arms that extend from the guard's housing into the catheter hub, where they engage an annular rib to create a secure, releasable connection. Petitioner argued this teaches a more robust and explicit arm structure than that found in Callaway.
    • Motivation to Combine: A POSITA, seeking to prevent unintentional separation of the hubs in the Woehr and Callaway combination, would have been motivated to incorporate Sutton's superior "duckbill" arm design. Sutton's teaching addresses the specific engineering problem of securely but releasably connecting a needle guard housing to a catheter hub, making it an obvious solution for improving the Callaway design.
    • Expectation of Success: Sutton states that its duckbill release mechanism is not limited in use and can be implemented with various clip-based and non-clip-based needle guards. This express teaching of interchangeability would have provided a POSITA with a high degree of confidence that modifying the Woehr/Callaway device with Sutton's arm mechanism would be successful.
  • Additional Grounds: Petitioner asserted additional obviousness challenges, including combinations of Woehr, Villa, and Sutton, as well as combinations including Nakajima (Application # 2002/0128604) to teach alternative valve-actuating elements for claim 22.

4. Key Claim Construction Positions

  • "needle protective device": Petitioner argued this term, recited in all challenged claims, should be construed as a means-plus-function term under 35 U.S.C. §112, ¶ 6. The claimed function is "to prevent unintended needle sticks," and the corresponding structure is the specific tip protector embodiments and their equivalents disclosed in the ’247 patent specification and its incorporated references. Petitioner asserted the term "device" itself imparts no structure, and the modifier "needle protective" is purely functional. This construction was central to the argument, although Petitioner also maintained that the prior art disclosed structures identical to those in the patent, meaning the claims are obvious even under a broader, non-means-plus-function construction.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 12, 13, 20-23, and 29 of the ’247 patent as unpatentable.