PTAB

IPR2019-00980

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 ’486 patent discloses a drive mechanism for a pen-type medication injector used for self-administering drugs. The invention centers on a specific six-component assembly comprising a main housing, a dose dial sleeve, a dose knob, a piston rod that is non-rotatable during dose setting, a driver, and a tubular clutch that interact to set and dispense a precise dose of medicine.

3. Grounds for Unpatentability

Ground 1: Obviousness over Steenfeldt-Jensen - Claims 1-6, 12-18, 20, 23, 26-30, 32-33, 36, and 38-40 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 discloses an injection syringe with a six-component structure that is directly analogous to the one claimed in the ’486 patent. Specifically, Petitioner mapped Steenfeldt-Jensen’s housing (1), scale drum (80), dose setting button (81), piston rod (6), and bushing (82) to the claimed main housing, dose dial sleeve, dose knob, piston rod, and tubular clutch, respectively. Petitioner contended the only significant difference in independent claim 1 is that Steenfeldt-Jensen’s driver (driver tube 85) engages its piston rod via a non-circular bore to transmit rotational force, whereas claim 1 requires the driver to have "internal threading" for this purpose. Petitioner further argued that Steenfeldt-Jensen taught the additional limitations of the challenged dependent claims, including a window for dose viewing (claims 3-4), a clicker mechanism providing audible and tactile feedback (claims 14-18, 20), and an insert for securing the piston rod against rotation (claims 38-40).
    • Motivation to Combine (Modification): Petitioner asserted that Steenfeldt-Jensen itself provides the motivation to make the necessary modification. The reference explicitly states that “[e]mbodiments may be imagined wherein…a nut element is rotated by the driver tube.” Petitioner argued a person of ordinary skill in the art (POSA) would have understood this as a direct suggestion to replace the disclosed non-circular bore engagement with a conventional threaded nut-and-bolt mechanism, which would involve providing the driver tube with internal threading to function as the nut element.
    • Expectation of Success: A POSA would have had a high expectation of success in making this modification. The substitution of one known mechanical means (non-circular bore) for another (threaded engagement) to convert rotational motion into linear motion was a simple and predictable design choice. Because Steenfeldt-Jensen's own disclosure suggested the interchangeability, a POSA would have reasonably expected the modified device to operate in the same manner to achieve the same result of driving the piston rod.

Ground 2: Obviousness over Møller and Steenfeldt-Jensen - Claims 1-6, 12-18, 20, 23, 26-30, 32-33, 36, and 38-40 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 contended that Møller discloses an injection device having the same six structural components recited in claim 1, including a driver (connection bars 12 with nut 13) that has internal threading and engages an external thread on the piston rod. The primary difference identified by Petitioner was the nature of the threaded engagement between the dose dial sleeve and the housing. Møller’s dose dial sleeve (dose setting drum 17) uses an internal thread to engage a corresponding external thread on a tubular element of the housing. In contrast, claim 1 requires the dose dial sleeve to have a helical groove on its outer surface that engages threading on the inner surface of the housing.
    • Motivation to Combine: Petitioner argued that Møller itself provides the motivation for the combination. Møller expressly discusses the Steenfeldt-Jensen device, noting its use of a high-pitch thread on the outer surface of the dose-setting drum. Although Møller identifies a perceived disadvantage, Petitioner argued a POSA would have recognized the benefit of Steenfeldt-Jensen's design—specifically, that its configuration reduces sliding friction, thus lowering the force needed to rotate the drum back into the housing during injection. A POSA would therefore combine Møller’s device with Steenfeldt-Jensen’s superior external drum threading to achieve this known advantage.
    • Expectation of Success: A POSA would have reasonably expected success, as the combination merely involved substituting one well-understood threaded engagement for another to achieve the predictable benefit of reduced friction. Implementing Steenfeldt-Jensen's external sleeve threading into Møller's device was presented as a routine task for a skilled artisan that would not alter the fundamental principle of operation.

4. Key Claim Construction Positions

  • Petitioner stated its arguments apply under the plain and ordinary meaning of the claim terms but also demonstrated obviousness using several constructions proffered by the Patent Owner in related district court litigation for terms including "driver," "main housing," and "tubular clutch."
  • As an alternative position, Petitioner asserted that if the terms "clutch," "clicker," and "insert" were construed under 35 U.S.C. §112, ¶6 (pre-AIA) as means-plus-function limitations, the prior art references disclose corresponding structures that perform the claimed functions. Under this alternative construction, Petitioner argued the challenged claims remained obvious.

5. Relief Requested

  • Petitioner requests the institution of an inter partes review and cancellation of claims 1-6, 12-18, 20, 23, 26-30, 32-33, 36, and 38-40 of Patent 8,992,486 as unpatentable under 35 U.S.C. §103.