PTAB

IPR2019-00979

Pfizer Inc v. Sanofi Aventis Deutschland

Log In
Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Pen-Type Injector
  • Brief Description: The ’069 patent relates to a drive mechanism for a pen-type injector used for the self-administration of medicine, such as insulin. The mechanism comprises six core components: a main housing, a dose dial sleeve, a dose dial grip, a non-rotatable piston rod, a drive sleeve, and a tubular clutch.

3. Grounds for Unpatentability

Ground 1: Obviousness over Burroughs - Claims 1-3 are obvious over Burroughs

  • Prior Art Relied Upon: Burroughs (Patent 6,221,046).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Burroughs disclosed a medication dispensing pen with the same six-component structure recited in claim 1. Burroughs’ device included a main housing, a dose dial grip, a non-rotatable piston rod (leadscrew 38), a drive sleeve (nut 36), and a tubular clutch (button 32). The only distinction identified was that Burroughs’ dose dial sleeve (dial mechanism 34) featured an external helical rib that engaged with a corresponding helical groove on the housing, whereas claim 1 requires a helical groove on the sleeve’s outer surface to engage threading on the housing.
    • Motivation to Combine (for §103 grounds): Petitioner contended that swapping the placement of a rib-to-groove threaded connection was a common and well-known design choice for providing relative rotational movement. A person of ordinary skill in the art (POSA) would have viewed placing the groove on the sleeve and the rib/thread on the housing, or vice versa, as a routine and interchangeable design choice based on the predictable use of prior art elements.
    • Expectation of Success (for §103 grounds): A POSA would have reasonably expected that reversing the rib and groove features would not change the rotational operability between the dial mechanism and the housing, allowing the components to perform their same, predictable functions.

Ground 2: Obviousness over Steenfeldt-Jensen - Claim 1 is obvious over Steenfeldt-Jensen

  • Prior Art Relied Upon: Steenfeldt-Jensen (Patent 6,235,004).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Steenfeldt-Jensen disclosed an injection syringe comprising all the components and structural limitations of claim 1. However, Petitioner acknowledged that the drive sleeve in Steenfeldt-Jensen (driver tube 85) rotationally engaged the piston rod through a non-circular bore, rather than the claimed "internal threading near a distal portion."
    • Motivation to Combine (for §103 grounds): Petitioner argued that Steenfeldt-Jensen itself expressly contemplated the necessary modification. The reference suggested that alternative embodiments could be imagined where a "nut element is rotated by the driver tube," which a POSA would have understood to mean modifying the driver tube to include an internal threading for engaging the piston rod’s external threading. This modification would merely swap the functions of two existing components as described in the reference.
    • Expectation of Success (for §103 grounds): A POSA would have reasonably expected that implementing the suggested modification would result in the device operating in the same predictable manner, with the new threaded engagement causing the piston rod to advance axially during injection.

Ground 3: Obviousness over Møller and Steenfeldt-Jensen - Claim 1 is obvious over Møller in view of Steenfeldt-Jensen

  • Prior Art Relied Upon: Møller (Application # 2002/0052578) and Steenfeldt-Jensen (Patent 6,235,004).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Møller disclosed an injection device with the same six core components as claim 1. However, Møller’s dose dial sleeve (dose setting drum 17) used an internal thread to engage the housing, failing to teach the claimed limitation of a "helical groove provided along an outer surface" of the sleeve. Steenfeldt-Jensen was cited for its teaching of a dose dial sleeve with a high-pitch external helical groove for engaging the housing.
    • Motivation to Combine (for §103 grounds): A POSA would combine these references to improve Møller's design. Møller explicitly discussed the Steenfeldt-Jensen device and its high-pitch threaded engagement but criticized it for friction loss. Petitioner argued a POSA would recognize that Steenfeldt-Jensen’s specific thread configuration was designed to reduce friction and would have been motivated to replace Møller's internal thread with Steenfeldt-Jensen's external groove design to gain this benefit, even if Møller preferred a different overall solution (gearing).
    • Expectation of Success (for §103 grounds): A POSA would have reasonably expected that incorporating Steenfeldt-Jensen's high-pitch external groove onto Møller's drum would reduce the force needed to rotate the drum and would retain the necessary rotational movement without negatively affecting the function of Møller’s direct-gear coupling.

4. Key Claim Construction Positions

  • Petitioner stated that claim terms should be given their ordinary and customary meaning. However, Petitioner also highlighted several constructions proffered by the Patent Owner in related district court litigation, which Petitioner asserted the Patent Owner could not now argue are unreasonable. Key constructions included:
  • "drive sleeve": "An essentially tubular component of essentially circular cross-section releasably connected to the dose dial sleeve that drives the piston during dose dispensing."
  • "main housing": "An exterior unitary or multipart component configured to house, fix, protect, guide, and/or engage with one or more inner components."
  • "tubular clutch": "A tubular structure that couples and decouples a moveable component from another component."

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-3 of the ’069 patent as unpatentable under 35 U.S.C. §103.