PTAB

IPR2017-01588

Becton Dickinson Co v. B Braun Melsungen AG

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Safety Catheter Assembly
  • Brief Description: The ’247 patent describes an over-the-needle catheter assembly with integrated safety features designed to prevent accidental needlesticks and control blood leakage after use. The invention combines a needle tip protector, a valve that seals upon needle withdrawal, and a valve actuating element, with the challenged claims specifically requiring the tip protector to be housed within a "third hub" structure.

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 ’247 patent’s named inventors, discloses a complete safety catheter assembly with nearly all claimed elements, including a blood-control valve, a valve actuator, and a spring clip needle protector. Petitioner asserted the only missing limitation was the housing of this protector within a "third hub." Callaway was cited to teach this missing element, disclosing a catheter assembly with three distinct hubs, where the middle hub serves as a housing for a needle safety clip identical to that in Woehr.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) would combine Woehr’s catheter with Callaway’s third hub to improve safety and security. Callaway explicitly teaches that its hub structure "protect[s] users from the sharp needle tip" and provides a secure cover for the tip protector, preventing it from being dislodged. This provided a clear reason to add Callaway’s known housing solution to Woehr’s otherwise complete device.
    • Expectation of Success: Success was predictable, as the combination merely involved placing a known safety clip (from Woehr) into a known protective housing (from Callaway) to achieve the expected benefits of enhanced user safety and device integrity.

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: Similar to Ground I, Woehr was asserted as the primary reference disclosing the base catheter, valve, and safety clip. Villa was presented as an alternative to Callaway for teaching the required third hub. Villa discloses a protective housing that surrounds a needle safety device, which is described as an "extension piece" that can be coupled to the catheter hub.
    • Motivation to Combine: A POSA would have been motivated to modify Woehr’s device by incorporating the protective housing from Villa to gain the advantages Villa explicitly describes. These benefits included a reduction in the "risk of contact with patient’s body fluids" and the prevention of "accidental pricking and the causing of wounds." Placing Woehr’s internal safety clip inside Villa’s external housing was argued to be a straightforward design choice to improve operator safety.
    • Expectation of Success: The combination was expected to succeed because it involved integrating two well-understood safety features—an internal clip and an external housing—to predictably minimize both needlestick and biohazard exposure risks.

Ground III: Claims 12-13, 20-23, and 29 are obvious over Woehr, Callaway, and 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 built upon the Woehr and Callaway combination by further modifying it with teachings from Sutton. While Woehr and Callaway supplied the core assembly and third hub, Sutton was cited for teaching a specific improvement to the claimed "arm" that connects the third hub to the catheter hub. Sutton discloses "duckbill" arms that extend distally to releasably engage an internal rib in the catheter hub, creating a more secure connection than a simple friction fit.
    • Motivation to Combine: A POSA would be motivated to modify the Woehr/Callaway device with Sutton’s duckbill arm design to achieve a more reliable connection between the hubs. Callaway’s hubs fit together with "slight friction," which might not prevent unintentional separation. Sutton’s design provides a known, superior locking mechanism that would predictably improve the assembly's robustness.
    • Expectation of Success: A POSA would have had a reasonable expectation of success in substituting Sutton’s connection mechanism for the simple friction fit suggested by Callaway. Sutton itself teaches that its duckbill release mechanism is versatile and not limited to a specific type of needle guard, making its application to the Woehr/Callaway assembly predictable.
  • Additional Grounds: Petitioner asserted additional obviousness challenges, including combinations of Woehr, Villa, and Sutton. Several grounds specific to dependent claim 22 were also asserted, adding Nakajima (Application # 2002/0128604) to the primary combinations to teach a valve actuating element that remains engaged with the valve after use.

4. Key Claim Construction Positions

  • Petitioner dedicated a substantial portion of its argument to the construction of the term "needle protective device."
  • Petitioner contended this term should be construed as a means-plus-function limitation under 35 U.S.C. §112, ¶ 6 because the claim term fails to recite a sufficiently definite structure.
  • The claimed function was identified as "to prevent unintended needle sticks in a protective position."
  • The corresponding structure identified in the ’247 patent’s specification was argued to be the disclosed "tip protector" (e.g., a spring clip) and its structural equivalents. This construction was central to Petitioner's argument that the spring clips disclosed in the prior art, like Woehr, met this claim limitation.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 12, 13, 20, 21, 22, 23, and 29 of Patent 8,460,247 as unpatentable under 35 U.S.C. §103.