PTAB

IPR2018-01159

West Pharmaceutical Services, Inc. v. Sanofi-Aventis Deutschland GmbH

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1. Case Identification

2. Patent Overview

  • Title: Safety Device for a Pre-filled Syringe
  • Brief Description: The ’011 patent discloses a safety device for pre-filled syringes designed to prevent accidental needlestick injuries. The device primarily consists of a hollow support body to hold the syringe, a hollow needle shield that covers the needle, an outer body that functions as a handle, and a guiding mechanism that controls the relative movement of the needle shield.

3. Grounds for Unpatentability

Ground 1: Obviousness over Carrel in view of David-Hegerich - Claims 1-13, 18, and 20 are obvious over Carrel in view of David-Hegerich.

  • Prior Art Relied Upon: Carrel (Application # 2009/0024093) and David-Hegerich (Application # 2008/0228147).
  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner asserted that Carrel discloses all major components of the claimed safety device except for an outer body that is slidably arranged relative to the support body to perform an injection. Carrel teaches a safety device for a pre-filled syringe with a hollow support body (support 3), a hollow needle shield (sleeve 4), and a "pin-and-track" guiding mechanism (peg 6 in passageway 10) that controls the shield's movement between retracted and extended positions. Petitioner argued this combination of elements meets most limitations of independent claims 1 and 20.

      The sole feature Petitioner contended is missing from Carrel is the slidable outer body. This element, Petitioner argued, is taught by David-Hegerich. David-Hegerich discloses an injection device with a "hollow tubular handle 10" (the claimed outer body) that is grasped by the user and slides relative to the other components to perform an injection. This handle is specifically designed to be ergonomic, receive a needle guard and syringe, and drive a plunger to expel medication. Petitioner argued that adding the slidable handle of David-Hegerich to the device of Carrel would result in the invention claimed in the ’011 patent.

      Petitioner further contended that the dependent claims merely add well-known features that are also disclosed or made obvious by the combination. For example, claim 2's anti-rotation tongue and groove is taught by Carrel's "longitudinal bulges 29" and "slideways 30." Claim 5's spring-energized flexible arm is taught by Carrel's helical spring 14, which acts on the needle shield and support body. Claim 8's non-biased arm is taught by David-Hegerich's track follower 82, which has a "relaxed position."

    • Motivation to Combine (for §103 grounds): Petitioner argued a person of ordinary skill in the art (POSITA) would combine Carrel and David-Hegerich because both address the same problem of providing a safe injection device. A POSITA would have been motivated to modify Carrel's small device with David-Hegerich's slidable handle to improve ergonomics and ease of use, particularly for patients with limited dexterity. David-Hegerich expressly teaches that its wide, slidable handle provides a stable grip and is suitable for self-administration by such patients. Furthermore, incorporating the slidable handle would improve the injection stroke by allowing the injection force to be applied closer to the injection site, reducing the likelihood of the plunger binding.

    • Expectation of Success (for §103 grounds): Petitioner asserted that a POSITA would have had a reasonable expectation of success in implementing David-Hegerich's slidable outer handle onto Carrel's device. The modification was argued to be a routine matter of design choice, as it involved combining known components to achieve a predictable result of improved handling and ergonomics.

4. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-13, 18, and 20 of Patent 9,586,011 as unpatentable.