PTAB

IPR2017-01586

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

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1. Case Identification

2. Patent Overview

  • Title: Over-the-Needle Catheter Insertion Device
  • Brief Description: The ’762 patent describes a method of manufacturing an over-the-needle catheter insertion device. The device is designed to accomplish two main objectives: first, to prevent blood outflow from the catheter hub after the needle is removed by using a check valve, and second, to automatically cover the sharp needle tip upon withdrawal to prevent accidental needlestick injuries to healthcare personnel.

3. Grounds for Unpatentability

Ground I: 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 asserted that Woehr disclosed a method of manufacturing a safety IV catheter with all the elements of independent claim 18 except for a valve and valve actuator. Woehr taught a “needle protective device” in the form of a spring clip that is structurally identical to the one disclosed in the ’762 patent. Petitioner argued that Tauschinski, in turn, disclosed a well-known self-sealing connector for catheters that taught the missing elements: a valve (elastic disc with a slit) and a valve actuator to prevent blood leakage.
    • Motivation to Combine: A person of ordinary skill in the art (POSA) would have been motivated to combine the teachings of Woehr and Tauschinski to arrive at the claimed invention. The goal was to improve Woehr’s safety catheter, which focused on needlestick prevention, by adding the known blood-sealing valve from Tauschinski. This would solve two well-understood problems in the field—needlestick injury and blood exposure—using a combination of known solutions for each.
    • Expectation of Success: A POSA would have had a reasonable expectation of success because combining a safety clip and a sealing valve were both known techniques in IV catheter design. Petitioner contended the combination involved simple mechanical components that would predictably perform their respective, independent functions without unexpected results or interference.

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

  • Prior Art Relied Upon: Van Heugten (Patent 5,053,014).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground was presented as an alternative in the event the Board did not construe "needle protective device" as a means-plus-function term. Petitioner argued that Van Heugten, a single reference, disclosed every element of the method claimed in independent claim 18. Specifically, Van Heugten taught a catheter with a controlled valve, including a catheter hub, a valve membrane, a sliding valve actuator (“membrane opener”), and a needle guard that serves as a needle protective device, with all components arranged in-line as required by the claim.
    • Motivation to Combine (for §103 grounds): Not applicable for a single-reference ground. The argument was that Van Heugten alone renders the claims obvious.
    • Key Aspects: This ground asserted that all claimed features were present in a single prior art device designed to solve the same problems as the ’762 patent. Petitioner mapped each step of claim 18—forming the hub, positioning the valve, positioning the actuator, and positioning the protective device—directly to figures and descriptions within Van Heugten.

Ground III: Claim 25 is obvious over Van Heugten in view of Lynn.

  • Prior Art Relied Upon: Van Heugten (Patent 5,053,014) and Lynn (WO 01/12249).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground built upon the teachings of Van Heugten to challenge dependent claim 25, which added the limitation that the needle protective device comprises a “resilient portion made from a metallic material.” While Van Heugten disclosed a needle guard, Petitioner argued Lynn taught an automated, spring-retracted needle protection mechanism. Lynn explicitly described a metallic retraction spring and trigger retainer, a system marketed as ‘Autoguard,’ to automatically withdraw the needle into a protective housing.
    • Motivation to Combine: A POSA would combine these references to automate and improve the manual needle guard of Van Heugten. The motivation was to replace a user-activated safety feature with a more reliable, automated spring-based mechanism, a well-recognized trend in the art to enhance safety and ease of use. Lynn provided the exact metallic, resilient component needed to achieve this known advantage.
    • Expectation of Success: Success would be expected, as implementing an automated spring retraction mechanism into a catheter assembly was a known and straightforward design modification.

  • Additional Grounds: Petitioner asserted an additional obviousness challenge (Ground IV) against claim 22 based on Van Heugten in view of Tauschinski, arguing the combination taught a valve actuator with a frustoconical distal end.

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 (pre-AIA).
    • Proposed Construction: Petitioner argued the term is a "nonce" word that fails to recite a sufficiently definite structure. Therefore, it should be construed as performing the function of "prevent[ing] unintended needle sticks." The corresponding structure identified in the ’762 patent specification for performing this function is a "spring clip" and its structural equivalents.
    • Importance to Argument: This construction was central to Ground I. By limiting the claim's scope to a specific "spring clip" structure, Petitioner could directly map it to the identical spring clip found in the Woehr prior art, strengthening the obviousness case. The petition presented alternative grounds (II, III, and IV) in case the Board adopted a broader, plain-and-ordinary-meaning construction.

5. Relief Requested

  • Petitioner requested 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.