PTAB

IPR2019-00977

Pfizer Inc v. Sanofi Aventis Deutschland

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Pen-Type Injector
  • Brief Description: The ’044 patent relates to a drive mechanism for a pen-type injector used for the self-administration of medicine, such as insulin. The invention focuses on the housing and internal components that allow a user to set and dispense a specific dose of medication.

3. Grounds for Unpatentability

Ground 1: Obviousness over Burroughs - Claims 11, 14, 15, 18, and 19 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, which discloses a multi-use medication dispensing pen, teaches all limitations of the challenged claims. Independent claim 11 recites a housing part comprising six key components: a main housing, a dose dial sleeve, a dose dial grip, a non-rotatable piston rod, a drive sleeve, and a tubular clutch. Petitioner asserted that Burroughs discloses each of these components performing the same functions as claimed. Specifically, Burroughs’ “housing 22” corresponds to the main housing, its “dial mechanism 34” to the dose dial sleeve, its “proximal portion 78” to the dose dial grip, its “leadscrew 38” to the piston rod, its “nut 36” to the drive sleeve, and its “button 32” to the tubular clutch.

    • Petitioner contended that the only notable difference between Burroughs and claim 11 is the specific configuration of the threading between the dose dial sleeve and the main housing. Claim 11 requires a helical groove on the outer surface of the dose dial sleeve that engages with a threading (i.e., a rib) on the main housing. In contrast, Burroughs discloses the inverse arrangement: a helical rib (in the form of threads 110, 112) on its dial mechanism that engages with a corresponding helical groove in the housing.

    • For the dependent claims, Petitioner argued that Burroughs’ “finger 170” and “splines 150” mechanism, which provides audible and tactile feedback as a dose is dialed, meets the “clicker” limitation of claims 14 and 15. Furthermore, Petitioner mapped the relative positioning requirements of claims 18 and 19, arguing that Burroughs’ dose dial sleeve is located outside its tubular clutch and radially inward of the main housing, as required.

    • Motivation to Combine (for §103 grounds): The petition asserted that a person of ordinary skill in the art (POSITA) would have been motivated to modify Burroughs by reversing the rib-and-groove configuration between the dial mechanism and the housing. Petitioner argued that a rib-to-groove threaded connection is a common and well-known mechanism for providing relative rotational movement between components. The decision of whether to place the rib on one component and the groove on the other, or vice-versa, would have been seen as a routine design choice and an obvious, interchangeable alternative to achieve the same established function.

    • Expectation of Success (for §103 grounds): A POSITA would have had a reasonable expectation of success in making this modification. Petitioner argued that reversing the placement of the rib and groove is a predictable design variation that would not change the fundamental rotational operability of the components. The modified device would predictably perform the same function of rotatable engagement between the dose dial sleeve and the housing.

4. Key Claim Construction Positions

  • Petitioner stated that for this proceeding, claim terms could be given their ordinary and accustomed meaning. However, it highlighted several constructions proffered by the Patent Owner in related district court litigation, which Petitioner adopted for its analysis.
  • 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.”
  • Petitioner also addressed the possibility that terms like “tubular clutch” and “clicker” could be interpreted under 35 U.S.C. §112, para. 6 as means-plus-function limitations. For the “tubular clutch,” Petitioner identified the function as coupling/decoupling components and the corresponding structure as component 60 and its associated features in the ’044 patent’s figures.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 11, 14, 15, 18, and 19 of the ’044 patent as unpatentable.