PTAB

IPR2018-01054

3M Co v. Aptar France SAS

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Petition
petition

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, equipped with a dose indicator device. The central inventive concept is a mechanism designed to prevent the undercounting of doses by ensuring the counter actuates even after a user performs a predetermined incomplete actuation stroke.

3. Grounds for Unpatentability

Ground 1: Obviousness over Elliott in view of Rhoades - Claims 1-3, 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 disclosed a conventional metered-dose inhaler (MDI) with a dose counter that converts axial motion to rotational motion. Rhoades, which was not considered during prosecution, taught a simple, inexpensive, and mass-producible mechanism within a mechanical ballpoint pen that also converts axial motion into rotational motion using a cam body and stationary stop members. The proposed combination involved substituting the relatively complex counter mechanism in Elliott with the simpler, more reliable, and commercially proven mechanism from Rhoades. The integral stop members taught by Rhoades, when incorporated into the Elliott inhaler body, would satisfy the claim limitation of actuating upon an incomplete stroke, thereby preventing undercounting.
    • Motivation to Combine: Petitioner contended that by the early 2000s, FDA guidance strongly encouraged the integration of reliable dose counters into MDIs to improve patient safety by preventing undercounting. A person of ordinary skill in the art (POSITA) would therefore be motivated to improve existing designs like Elliott for cost-effective mass production and enhanced reliability. Petitioner asserted that a POSITA would look to analogous arts, such as mechanical pens, for a proven and inexpensive mechanism like that in Rhoades to solve this known problem.
    • Expectation of Success: The combination was presented as a predictable substitution of known mechanical elements to perform their established functions. Petitioner argued a POSITA would have a high expectation of success in integrating the Rhoades mechanism into an MDI using standard manufacturing techniques like injection molding.

Ground 2: Obviousness over Bason in view of Rhoades - Claims 1-3, 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: Petitioner asserted that Bason disclosed another known MDI with a top-mounted dose counter. The argument paralleled Ground 1, proposing the replacement of Bason’s counting mechanism with the one from Rhoades. In this combination, the stationary guide member and integral stop members of Rhoades would be molded directly into the Bason inhaler body, creating the claimed "stationary body including... a stationary gear." This configuration would use the reliable cam-based actuation from Rhoades to prevent undercounting, just as argued for the combination with Elliott.
    • Motivation to Combine: The motivation was identical to that in Ground 1. A POSITA would be driven by regulatory pressure and market demands to improve the Bason design to make it less expensive, more reliable, and suitable for mass production while addressing the critical industry need to prevent dose undercounting. The Rhoades mechanism offered a well-understood, off-the-shelf solution from an analogous field.
    • Expectation of Success: As with the first ground, Petitioner argued the substitution was a predictable combination of known elements from analogous arts. The resulting device's properties and functionality would have been readily apparent to a POSITA, leading to a high expectation of success.

4. Key Claim Construction Positions

  • Petitioner argued for adopting a specific claim construction for the term "a stationary body (1) including at least one stationary gear (110, 122)" based on the patent’s prosecution history.
  • The proposed construction, previously adopted by the Patent Trial and Appeal Board during prosecution, was: "a stationary body including, as a unitary or monolithic part of the stationary body, at least one stationary gear."
  • This construction was critical to Petitioner's arguments because it distinguished prior art like Bason (which was found to have a separate gear component) and supported the argument that incorporating the unitary stop members of Rhoades into an inhaler body would meet this limitation.

5. Key Technical Contentions (Beyond Claim Construction)

  • A central technical contention was that the mechanism of a retractable mechanical pen, as disclosed in Rhoades, is analogous art to the dose counter of an MDI.
  • Petitioner argued that a POSITA in the field of MDI design would have recognized that both technologies address the same fundamental mechanical problem: converting a user's linear input (pushing a button) into controlled rotational movement for actuation or counting.
  • This analogy was foundational to the motivation to combine arguments in both grounds, justifying why a designer would look beyond the immediate field of medical devices to solve a known engineering challenge.

6. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1-3, 9, and 21 of Patent 8,936,177 as unpatentable under 35 U.S.C. §103.