PTAB

IPR2018-01054

3M Company v. Aptar France SAS

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1. Case Identification

2. Patent Overview

  • Title: FLUID PRODUCT DISPENSER
  • Brief Description: The ’177 patent discloses a fluid dispenser, such as a metered-dose inhaler (MDI), that includes a dose indicator device. The device features mechanical components, including cooperating gears, designed to prevent the undercounting of dispensed doses by ensuring actuation of the counter even after an incomplete actuation or return stroke.

3. Grounds for Unpatentability

Ground 1: Claims 1, 2, 3, 9, and 21 are obvious over Elliott in view of Rhoades.

  • Prior Art Relied Upon: Elliott (GB 1317315) and Rhoades (Patent 3,205,863).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Elliott discloses a foundational MDI with a dose counter that converts axial motion to rotational motion. Rhoades, a patent for a retractable ballpoint pen, was presented as analogous art disclosing a simple, inexpensive, and reliable mechanism for converting axial-to-rotational motion that was suitable for mass production. Petitioner asserted that a Person of Ordinary Skill in the Art (POSA) would substitute the robust and cost-effective mechanism from Rhoades for the counter in Elliott. Specifically, the stop members and cam body in Rhoades would be incorporated into the Elliott inhaler body, providing the claimed features of actuating after a predetermined incomplete stroke and preventing re-dispensing until the counter resets.
    • Motivation to Combine: The primary motivation was strong industry and regulatory pressure, particularly FDA guidance from 2001 and 2003, which recommended that new MDIs include reliable dose counters designed specifically to avoid dangerous undercounting. A POSA seeking to improve existing MDIs like Elliott for mass production would look to analogous arts like the mechanical pen in Rhoades to find a proven, cost-effective, and reliable mechanism. This substitution would predictably result in a more reliable and less expensive inhaler that addressed the known safety concerns.
    • Expectation of Success: A POSA would have a reasonable expectation of success because the combination involved substituting known mechanical components that would retain their respective functions. The manufacturability of such a device using well-understood methods like injection molding was predictable. A POSA would also know how to coordinate the mechanical tolerances of the Rhoades mechanism with the inhaler’s valve travel to ensure the counter actuates before fluid is dispensed, thereby avoiding undercounting.

Ground 2: Claims 1, 2, 3, 9, and 21 are obvious over Bason in view of Rhoades.

  • Prior Art Relied Upon: Bason (Patent 6,283,365) and Rhoades (Patent 3,205,863).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground presented a parallel argument to Ground 1, using Bason as the primary reference. Bason discloses a top-mounted dose counter for an MDI that also converts axial to rotational motion. Petitioner argued that, for the same reasons articulated in Ground 1, a POSA would be motivated to replace the counting mechanism in Bason with the simpler, cheaper, and more reliable mechanism from Rhoades. The Rhoades mechanism would be incorporated at the top of the Bason inhaler, with its cam body modified to display numbers, to achieve the claimed functionality.
    • Motivation to Combine: The motivation was identical to that in Ground 1: a POSA would combine the references to meet the market and regulatory demand for reliable, mass-producible MDIs with dose counters that prevent undercounting. The substitution would improve Bason by reducing the number of components, lowering manufacturing costs, and increasing reliability, directly addressing goals explicitly stated in the ’177 patent’s specification.
    • Expectation of Success: The expectation of success was also identical to Ground 1. The combination represented a predictable substitution of familiar elements from an analogous art field (mechanical pens) into a known device type (MDIs). A POSA would have understood how to integrate the components to create a device that solved the undercounting problem.

4. Key Claim Construction Positions

  • "a stationary body (1) including at least one stationary gear (110, 122)": Petitioner argued that this term should be construed as it was by the PTAB during prosecution of the application leading to the ’177 patent: "a stationary body including, as a unitary or monolithic part of the stationary body, at least one stationary gear." This construction is critical because the patentee previously distinguished the Bason prior art by arguing Bason's gears were on a separate component, not a unitary part of the stationary body. Petitioner contended that the proposed combination with Rhoades would satisfy this "unitary" limitation, as the stop members (the claimed "stationary gear") in Rhoades are unitary with its stationary guide member.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1, 2, 3, 9, and 21 of the ’177 patent as unpatentable under 35 U.S.C. §103.