PTAB

IPR2017-01590

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 ’641 patent describes an over-the-needle catheter insertion device designed to enhance safety. The invention incorporates two primary features: a valve within the catheter hub to minimize blood exposure after the needle is withdrawn, and a safety device, such as a spring clip, that automatically covers the needle tip to prevent accidental needlesticks.

3. Grounds for Unpatentability

Ground 1: Obviousness over Woehr and Callaway - 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 for this Ground:
    • Prior Art Mapping: Petitioner argued that Woehr disclosed a safety catheter assembly with nearly all the claimed elements, including a catheter hub, a needle hub, a valve for limiting fluid flow, and a safety device in the form of a spring clip that covers the needle tip upon withdrawal. However, Woehr’s safety device was not contained within a separate housing. Callaway was cited to remedy this deficiency, as it disclosed a catheter device with three hubs, including a "middle hub" that explicitly functions as a housing for a metal clip tip protector identical to the one in Woehr. The combination of Woehr's core device with Callaway's dedicated tip protector housing allegedly rendered independent claim 15 obvious. Dependent claims were also argued to be obvious, as Woehr disclosed the valve's deflectable slits (claim 17), frusto-conical valve opener (claim 18), and a resilient metal spring clip (claim 20).
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSA) would combine Woehr with Callaway to improve the safety and reliability of the needle protector. Petitioner asserted that Callaway explicitly taught that its "clip and hub (21) protect users from the sharp tip of the needle." A POSA would have recognized the benefit of enclosing Woehr's exposed spring clip within a dedicated housing, as taught by Callaway, to provide more secure protection, prevent inadvertent activation of the safety mechanism, and minimize contact with any residual fluids on the needle.
    • Expectation of Success: The combination involved integrating a known housing structure with a known safety clip in a catheter assembly, which was a simple and predictable modification. A POSA would have had a reasonable expectation of success in implementing this combination to achieve the well-understood goal of enhanced needlestick prevention.

Ground 2: Obviousness over Woehr and Villa - 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 for this Ground:
    • Prior Art Mapping: This ground presented an alternative combination for the same claims. As in Ground 1, Woehr was asserted to teach the fundamental safety catheter assembly with an exposed spring-clip tip protector. Villa was introduced to supply the missing "tip protector housing" limitation. Villa disclosed a protective device for a catheter needle comprising a hollow body or housing that surrounds safety means (e.g., bendable blocking arms). Critically, Villa taught that its housing is an extension piece that can be coupled to the proximal end of the catheter hub. Petitioner argued that substituting Woehr's exposed clip with a similar safety mechanism housed within the protective body taught by Villa would result in the claimed invention.
    • Motivation to Combine: A POSA would be motivated to modify Woehr's device by incorporating the housing taught by Villa to gain significant safety advantages. Villa's housing provided superior protection by containing the safety clip, which "considerably reduce[s] the risk of contact with patient’s body fluids." Unlike Woehr’s exposed clip, Villa’s enclosed design would better contain fluids remaining on the needle after use, accomplishing the predictable result of minimizing exposure risks for healthcare workers. The compact and versatile nature of Villa's housing would have made it an attractive and obvious improvement to the Woehr device.
    • Expectation of Success: Placing a known safety mechanism like Woehr’s spring clip inside a protective housing like Villa's was a straightforward design choice. A POSA would have reasonably expected this combination to function as intended, yielding the predictable benefits of improved safety and fluid containment.

4. Key Claim Construction Positions

  • "safety device": Petitioner dedicated significant argument to construing the term "safety device for covering the needle tip" as a means-plus-function term under 35 U.S.C. §112, ¶6.
    • Petitioner argued the claim language failed to recite sufficient structure to perform the stated function of "covering the needle tip." The word "device" was contended to be a generic nonce term, similar to "means," and the modifier "safety" only described the function, not the structure.
    • The petition asserted that the further claim language requiring a "tip protector housing" did not provide the necessary structure, as the specification described the housing as merely "accommodating" or "surrounding" the actual tip protector.
    • Petitioner identified the corresponding structure in the specification as the tip protectors themselves (e.g., various spring clips), not the housing. This construction was critical to the invalidity argument, as Woehr disclosed the structural "tip protector," while Callaway and Villa supplied the separate "tip protector housing."

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 15, 17, 18, 20, and 22 of Patent 9,370,641 as unpatentable.