PTAB

IPR2016-00245

Spangenberg Erich v. Alpex Pharma

Log In
Key Events
Petition
petition Intelligence

1. Case Identification

2. Patent Overview

  • Title: Orally Disintegrating Tablets with Speckled Appearance
  • Brief Description: The ’170 patent is directed to orally disintegrating tablets (ODTs) that have a visually speckled appearance. The invention achieves this look by incorporating colored granules of a water-soluble sugar into a mixture with a pharmaceutically acceptable carrier, with the stated purpose of aiding in product identification.

3. Grounds for Unpatentability

Ground 1: Claims 1-9 are obvious over the Prevacid Label in view of Stawski.

  • Prior Art Relied Upon: Prevacid Label (a 2007 product label for PREVACID®) and Stawski (Application # 2006/0193909).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the Prevacid Label discloses an orally disintegrating tablet with "orange to dark brown speckles" and lists mannitol (a water-soluble sugar) as an ingredient, thereby teaching most limitations of independent claim 1. However, the Prevacid Label does not explicitly state that the speckles themselves are composed of colored granules of a water-soluble sugar. Petitioner asserted that Stawski supplies this missing element by teaching tablets containing "abrasive inclusions" that can be made from colored granules of water-soluble sugars (specifically "blue colored mannitol inclusions") to provide a "contrasting color" to the tablet body. Petitioner further argued that Stawski teaches the specific sugars, particle sizes, and weight percentages recited in dependent claims 2-9.
    • Motivation to Combine: Petitioner contended that a person of ordinary skill in the art (POSITA), seeking to formulate the speckled tablet disclosed in the Prevacid Label, would have been motivated to use the well-known technique taught by Stawski. The combination was presented as the simple application of a known method (using colored sugar granules) to achieve a predictable and desired result (a speckled tablet appearance).
    • Expectation of Success: Petitioner asserted a POSITA would have had a reasonable expectation of success in producing a speckled tablet by incorporating Stawski's colored mannitol granules into the Prevacid tablet formulation, as it involved combining known, compatible components for their established functions.

Ground 2: Claims 1-3, 5, 6, 8, and 9 are obvious over the Prevacid Label in view of Serpelloni.

  • Prior Art Relied Upon: Prevacid Label (a 2007 product label) and Serpelloni (Patent 4,744,991).
  • Core Argument for this Ground:
    • Prior Art Mapping: Similar to Ground 1, Petitioner relied on the Prevacid Label for its disclosure of a speckled ODT containing a water-soluble sugar. To supply the teaching that the speckles are made of colored sugar granules, Petitioner pointed to Serpelloni. Although directed to chewing gum, Serpelloni was argued to teach the core concept: creating a "speckled appearance" by using "solid sweetening particles, colored and possibly flavored," specifically identifying colored particles of sorbitol. Petitioner asserted that Serpelloni also disclosed the specific types of sugars, particle sizes, and granule amounts required by the challenged dependent claims.
    • Motivation to Combine: Petitioner argued that Serpelloni is analogous art because it addresses the same technical problem as the ’170 patent—creating a speckled appearance in an oral product using colored sugar granules. A POSITA would have been motivated by market incentives to apply this known speckling technique from one field (chewing gum) to a closely related field (orally disintegrating tablets) to achieve the same aesthetic and identification benefits.
    • Expectation of Success: Petitioner contended that a POSITA would have reasonably expected that the colored sugar granules taught by Serpelloni to create a speckled effect in gum would function identically to create a similar speckled effect in a tablet, as the underlying principle is simple physical mixing of components.

4. Key Claim Construction Positions

  • "speckled appearance": Petitioner proposed this term be construed to mean "a tablet that has the look of being covered with small spots or patches of color." This construction was argued to be consistent with the specification's description of a "bicolored appearance characterized by the presence of spots of a different color on their surface."
  • "colored granules": Petitioner proposed defining this term as "small particles of a size from about 10 µm to about 1200 µm having or having been given color." This construction was based on explicit particle size ranges provided in the patent's specification.
  • "pharmaceutically acceptable carrier": As the term was not defined in the patent, Petitioner argued it should be given its well-understood meaning in the art: "a substance that can be included in the compositions of the invention and that causes no significant adverse toxicological effects to a patient."

5. Relief Requested

  • Petitioner requested institution of an inter partes review of claims 1-9 of Patent 8,440,170 and cancellation of those claims as unpatentable under 35 U.S.C. §103.