PTAB

IPR2019-00978

Pfizer Inc v. Sanofi Aventis Deutschland

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Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Pen-Type Injector
  • Brief Description: The ’044 patent describes a drive mechanism for a pen-type injector used for self-administering medicine. The mechanism allows a user to set a dose and then inject it using a system of interacting components, including a housing, a dose dial sleeve, a piston rod, and a clutch.

3. Grounds for Unpatentability

Ground 1: Claims 11, 14, 15, 18, and 19 are obvious over Steenfeldt-Jensen.

  • Prior Art Relied Upon: Steenfeldt-Jensen (Patent 6,235,004).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Steenfeldt-Jensen, a single prior art reference, disclosed a medicine-dispensing syringe that taught every element of independent claim 11. Specifically, Petitioner mapped the components of Steenfeldt-Jensen's device to the claimed elements: its "tubular housing 1" is the claimed main housing; "scale drum 80" is the dose dial sleeve with an external helical track; "dose setting button 81" is the dose dial grip; "piston rod 6" is the piston rod that is non-rotatable during dose setting; and "bushing 82" is the tubular clutch. Petitioner contended that Steenfeldt-Jensen’s "piston rod drive," comprising driver tube 85 and member 40, meets the limitations of the claimed "drive sleeve." The dependent claims were also allegedly taught; for instance, Steenfeldt-Jensen's description of radial protrusions and axial recesses that create a clicking sound during rotation was argued to teach the "clicker" of claims 14 and 15.
    • Motivation to Combine (for §103 grounds): As this ground relied on a single reference, the argument centered on inherency and direct disclosure. However, Petitioner addressed the "drive sleeve" limitation by arguing that even if Steenfeldt-Jensen's two-part piston rod drive was not a direct match, the reference itself expressly contemplated an alternative embodiment. This alternative involved modifying the device so the driver tube would contain internal threading to engage the piston rod, which Petitioner asserted a POSITA would have understood as disclosing the claimed "drive sleeve" structure.
    • Expectation of Success (for §103 grounds): A POSITA would have reasonably expected that modifying Steenfeldt-Jensen's piston rod drive as suggested by the reference itself would result in a predictably functioning device, as it involved rearranging known mechanical components (a nut element and a piston rod guide) for the same purpose.

Ground 2: Claims 11, 14, 15, 18, and 19 are 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-component structure as claim 11, teaching every limitation except for one detail of the dose dial sleeve. Møller disclosed a main housing, dose dial grip, non-rotatable piston rod, drive sleeve (connection bars 12 and nut 13), and a tubular clutch ("cup shaped element"). However, Møller’s dose dial sleeve ("dose setting drum 17") used an internal thread to engage the housing. Petitioner asserted that Steenfeldt-Jensen remedied this deficiency by teaching a dose dial sleeve with a "helical groove provided along an outer surface" that engages a corresponding rib on the inner wall of its housing. The dependent claims were argued to be obvious over the combination as both references disclosed clicker mechanisms providing audible feedback.
    • Motivation to Combine (for §103 grounds): A POSITA would combine these references because Møller explicitly discussed the Steenfeldt-Jensen device and identified a specific problem to be solved: high friction. Møller noted that in Steenfeldt-Jensen's design, where force is transferred via the drum's threaded rotation, "most of the transformed force is lost due to friction." Steenfeldt-Jensen taught that its external, high-pitch helical groove created a non-self-locking connection that reduced friction. A POSITA, seeking to improve Møller's design, would have been motivated to replace Møller's internal thread with Steenfeldt-Jensen's known, low-friction external helical groove to reduce the force needed to operate the device.
    • Expectation of Success (for §103 grounds): A POSITA would have had a reasonable expectation of success because incorporating Steenfeldt-Jensen's external groove onto Møller's drum was a simple substitution of one known threading mechanism for another to achieve the known benefit of reduced friction, without altering the fundamental operation of Møller's direct-gear coupling.

4. Key Claim Construction Positions

  • Petitioner noted that Patent Owner Sanofi had proffered constructions for key terms in related litigations and argued these constructions should apply.
    • 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."
  • Petitioner also addressed "tubular clutch" and "clicker" as potential means-plus-function terms, identifying corresponding structures in the ’044 patent (e.g., component 60 for the clutch) and arguing the prior art disclosed equivalent structures performing the identical functions.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 11, 14, 15, 18, and 19 of Patent 8,603,044 as unpatentable.