PTAB

IPR2015-00165

BioDelivery Sciences Intl Inc v. MonoSol RX LLC

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Oral Films for Delivery of an Active Component
  • Brief Description: The ’167 patent discloses orally consumable films for delivering active pharmaceutical ingredients. The claims are directed to a product defined by its composition (e.g., a water-soluble polymer matrix and an active component) and by the process used to make it, which is described as a "controlled drying process" that creates a viscoelastic matrix to achieve a "substantially uniform distribution" of the active ingredient.

3. Grounds for Unpatentability

Ground 1: Anticipation by Chen - Claims 1, 4, 6-8, 11, 12, 26, 27, 32, 38, 44, 51, 58, 65, 72, 82, 109, and 125-127 are anticipated under 35 U.S.C. §102 by Chen.

  • Prior Art Relied Upon: Chen (International Publication No. WO 00/42992).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Chen teaches every element of the challenged claims. Chen discloses oral films with a water-soluble polymer matrix, an active component, and various claimed anti-tacking agents (e.g., sodium benzoate, Vitamin E, surfactants). Petitioner asserted that Chen’s method of drying a homogenous mixture in a hot air circulating oven at a controlled temperature (50°C) for a specific time (9 minutes) meets the “controlled drying process” limitation. This process inherently results in a viscoelastic film that locks in the active component and achieves the claimed "substantially uniform distribution." Petitioner supported this by noting Chen’s reported dosage weight of 0.028 ± 0.001 g, a variation well within the patent's required threshold of less than 10%.
    • Key Aspects: Petitioner heavily emphasized that in a reexamination of the related ’588 patent, the Board had already found that Chen taught "controlled drying" and resulted in a film with "substantially uniform" active content. Petitioner argued this prior, final Board decision should collaterally estop the Patent Owner from contesting these findings.

Ground 2: Obviousness over Chen, Leung, and MODERN COATING - Claims 1, 4, 6-8, 11, 12, 26, 27, 32, 38, 44, 51, 58, 65, 72, 82, 109, and 125-127 are obvious over Chen in view of Leung and MODERN COATING.

  • Prior Art Relied Upon: Chen (WO 00/42992), Leung (WO 00/018365), and MODERN COATING (a 1992 textbook).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that Chen provides the foundational oral film composition and manufacturing process. To the extent any elements related to tackiness are not fully disclosed in Chen, Leung was cited for its teachings on formulating dissolvable oral films with optimized oil content to be "non-self-adhering," directly addressing limitations in claims 26, 27, and 127 concerning reduced coefficient of friction. If Chen’s process was deemed not to be a "controlled drying process," Petitioner relied on MODERN COATING, a standard textbook, which details the principal variables (e.g., temperature, air velocity, solvent content) and apparatus for controlling a drying process to produce a uniform film.
    • Motivation to Combine: A POSITA would combine Chen's film formulation with Leung's teachings on reducing tackiness to ensure successful production, packaging, and end-use of the film product. A POSITA seeking to guarantee the uniformity of the final film—a critical requirement for pharmaceutical dosage forms—would naturally turn to a standard industry reference like MODERN COATING to optimize the drying parameters of the process disclosed in Chen.
    • Expectation of Success: Petitioner argued there was a high expectation of success, as the combination involved applying well-understood principles and optimizing known variables for the predictable outcome of a uniform, non-tacky oral film.

Ground 3: Anticipation by Tapolsky - Claims 1, 4, 6-9, 11, 12, 26, 27, 32, 44, 51, 65, 72, 82, and 125-127 are anticipated under §102 by Tapolsky.

  • Prior Art Relied Upon: Tapolsky (WO 1999/055312).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued that Tapolsky provides an independent anticipatory reference. Tapolsky discloses a multi-layer pharmaceutical film for mucosal delivery comprising a water-soluble polymer matrix (hydroxyethyl cellulose), an active pharmaceutical agent (albuterol sulfate), and a claimed anti-tacking agent (sodium benzoate). Tapolsky explicitly discloses a controlled drying process, stating that film layers were dried at 60°C for specific times (8 and 20 minutes). Critically, Tapolsky reports a uniform active distribution of 1.46 mg/cm². Petitioner calculated that the precision of this reported value implies a maximum possible variation of only 0.61%, a value significantly better than the claimed requirement of not varying by more than 10%.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including that the claims are obvious over Chen alone, Chen in view of Leung, Tapolsky alone, and Tapolsky in view of MODERN COATING. These grounds relied on similar arguments that any claim element not explicitly or inherently disclosed by the primary reference would have been obvious to a POSITA.

4. Key Claim Construction Positions

  • "controlled drying process": Petitioner argued this term should be construed broadly as "drying with at least one controlled drying parameter" (such as temperature, air current, humidity, or time). Petitioner contended that the ’167 patent provides no meaningful process limitations beyond this general concept, does not distinguish its process from conventional drying, and even incorporates a prior art drying apparatus by reference.
  • "substantially uniform distribution": Petitioner argued that while the term is likely indefinite, for the purposes of the IPR it must be construed as it was during prosecution to overcome an indefiniteness rejection. The Patent Owner defined the term by the quantitative limitation recited in the claims, i.e., "measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said active component." Petitioner adopted this construction for its invalidity analysis.

5. Relief Requested

  • Petitioner requests institution of inter partes review and cancellation of claims 1, 4, 6-9, 11, 12, 26, 27, 32, 38, 44, 51, 58, 65, 72, 82, 109, and 125-127 as unpatentable.