PTAB

IPR2015-00165

BioDelivery Sciences International, Inc. v. MonoSol Rx, LLC.

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1. Case Identification

2. Patent Overview

  • Title: Oral Film for Delivery of an Active
  • Brief Description: The ’167 patent is directed to product claims for oral, water-soluble films used to deliver an active component. The claims include product limitations (e.g., polymer matrix, anti-tacking agent) and a product-by-process recitation requiring the film be formed by a "controlled drying process" that allegedly achieves a "substantially uniform distribution" of the active.

3. Grounds for Unpatentability

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

  • Prior Art Relied Upon: Chen (International Publication No. WO 00/42992).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Chen, which published more than one year before the ’167 patent’s priority date, discloses every limitation of the challenged claims. Chen describes oral films with an ingestible, water-soluble polymer matrix (HPMC), an active component, and anti-tacking agents (e.g., sodium benzoate, Vitamin E, surfactants). Petitioner asserted that Chen also discloses the key product-by-process limitation, teaching a process of drying a homogenous mixture in a hot air circulating oven at a controlled temperature for a set time, which constitutes a "controlled drying process." The resulting film is described as glossy, non-tacky, and having a consistent dosage weight (0.028 ± 0.001 g), which Petitioner contended inherently meets the claim requirement for a "substantially uniform distribution" that does not vary by more than 10%.
    • Key Aspects: Petitioner heavily relied on a collateral estoppel argument, asserting that in a final, unappealed decision for a related reexamination (the ’588 patent), the Board had already found that this same Chen reference teaches a "controlled drying" process and results in a film with "substantially uniform" active content well within the 10% variation limit. Petitioner argued that the Patent Owner should be estopped from re-litigating these same issues.

Ground 2: Anticipation over Tapolsky - Claims 1, 4, 6-9, 11, 12, 26, 27, 32, 44, 51, 65, 72, 82, and 125-127 are anticipated by Tapolsky under §102(b).

  • Prior Art Relied Upon: Tapolsky (International Publication No. WO 1999/055312).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner contended that Tapolsky, an earlier publication, also anticipates the challenged claims. Tapolsky discloses a pharmaceutical film device for mucosal delivery comprising a water-soluble polymer matrix (hydroxyethyl cellulose, hydroxypropyl cellulose), a pharmaceutical agent (albuterol sulfate), and an anti-tacking agent (sodium benzoate). Petitioner argued that Tapolsky’s Example 37 explicitly describes a "controlled drying process" by drying a gel layer at a specific temperature (60°C) for specific durations (8 and 20 minutes). Tapolsky reports a uniform active distribution of 1.46 mg/cm², which Petitioner calculated corresponds to a maximum variation of only 0.61%, far below the claimed 10% threshold.

Ground 3: Obviousness over Chen in view of Leung - Claims 26, 27, and 127 are obvious over Chen in view of Leung under 35 U.S.C. §103.

  • Prior Art Relied Upon: Chen (WO 00/42992) and Leung (International Publication No. WO 00/018365).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground was presented as an alternative for dependent claims 26, 27, and 127, which recite functional properties related to a reduced coefficient of friction and reduced adhesion. Petitioner argued that Chen discloses non-tacky films and methods for measuring tack. Leung is directed to dissolvable oral films and explicitly teaches optimizing oil content to create a "non-self-adhering film" that can be stored in a stack, thereby disclosing reduced adhesion and friction.
    • Motivation to Combine: A person of ordinary skill in the art (POSITA) starting with Chen's film formulation would have been motivated to consult a reference like Leung to optimize the film's properties. Achieving reduced adhesion and a low coefficient of friction is a known and beneficial goal for the successful production, packaging, and end-use of film products, making the combination an obvious design choice.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success in applying Leung's teachings to Chen's film, as both deal with similar water-soluble polymer films for oral delivery and address the common problem of tackiness.

  • Additional Grounds: Petitioner asserted additional challenges, including obviousness over Chen alone and Tapolsky alone as alternatives to the anticipation grounds. Further, Petitioner presented an obviousness combination of Chen, Leung, and MODERN COATING (a 1992 textbook on drying technology) to provide further evidence that using a controlled drying process to achieve uniformity was well-known and obvious.

4. Key Claim Construction Positions

  • "controlled drying process": Petitioner argued this term should be construed as "drying with at least one controlled drying parameter," such as temperature, time, air velocity, or humidity. Petitioner contended that the ’167 patent itself admits that "controlled drying processes" were known and provides examples (e.g., the Magoon patent) without defining any novel process steps. It was argued that the phrase "rapidly forms a viscoelastic matrix to lock-in" provides no meaningful process limitation, as any drying of a viscoelastic solution would inherently do this.
  • "substantially uniform distribution": Petitioner argued that in the context of the patent’s prosecution history, this term must be construed as a "distribution as measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said active component." The Patent Owner added this "whereby" clause during prosecution to overcome an indefiniteness rejection. Petitioner noted that while it believes the term is indefinite, this construction is required under the broadest reasonable interpretation standard given the prosecution history.

5. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1, 4, 6-9, 11, 12, 26, 27, 32, 38, 44, 51, 58, 65, 72, 82, 109, and 125-127 of Patent 8,765,167 as unpatentable.