PTAB

IPR2018-01586

Biofrontera Incorporated v. DUSA Pharmaceuticals Inc.

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1. Case Identification

2. Patent Overview

  • Title: Illuminator for Photodynamic Therapy
  • Brief Description: The ’991 patent relates to illuminators used for photodynamic therapy (PDT) or photodynamic diagnosis (PD) of dermatological conditions. The invention is a contoured, non-planar device designed to conform to a patient's body surface, such as the face, to deliver a uniform output of light.

3. Grounds for Unpatentability

Ground 1: Anticipation - Claims 1, 2, 7, 9, 11, and 12 are anticipated by Rowland.

  • Prior Art Relied Upon: Rowland (International Publication No. WO 90/00420).
  • Core Argument
    • Prior Art Mapping: Petitioner argued that Rowland discloses every element of the challenged claims. Rowland teaches a light device for PDT using a hemispherical shell that conforms to a contoured surface to provide "substantially uniform illumination" for treating skin conditions. This device includes a sensor and switch that act as a controller, and its shell diameter of 5-15 cm (2-4.5 inches) inherently discloses operation at the claimed distances of 2" and 4". For dependent claims, Rowland’s use of a 630 nm laser constitutes a non-fluorescent, red light source.
    • Key Aspects: Petitioner contended that Rowland’s core design of a contoured, reflective shell that provides uniform illumination directly reads on the key limitations of claim 1.

Ground 2: Obviousness over Rowland and Bower - Claims 1-12 are obvious over Rowland in view of Bower.

  • Prior Art Relied Upon: Rowland (WO 90/00420) and Bower (International Publication No. WO 93/21842).
  • Core Argument
    • Prior Art Mapping: Rowland was asserted to teach a base illuminator with a contoured shape for uniform irradiation. Bower was asserted to teach using arrays of light-emitting diodes (LEDs) on flexible or curved circuit boards to deliver a "uniform light dose" to non-flat surfaces for PDT. Petitioner argued that to the extent Rowland does not explicitly disclose a "plurality" of light sources or a more advanced controller, Bower supplies these elements by teaching configurable LED arrays with control units.
    • Motivation to Combine: A POSITA would combine the teachings of Rowland and Bower because both address the same problem of delivering uniform light for PDT. A POSITA would be motivated to replace Rowland's single light source with Bower's more versatile and configurable LED arrays to improve the illuminator's performance and applicability, which was a known design goal in the field.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success in combining the references, as it involved implementing a known light source technology (flexible LED arrays from Bower) into a known device architecture (a contoured illuminator from Rowland) to achieve the predictable result of a uniform, contoured light output.

Ground 3: Obviousness over Levin and Blaisdell - Claims 1-3, 6-8, and 10-12 are obvious over Levin in view of Blaisdell, further in view of the knowledge of a POSITA.

  • Prior Art Relied Upon: Levin (Patent 4,103,175) and Blaisdell (Patent 4,100,415).

  • Core Argument

    • Prior Art Mapping: Levin was argued to disclose a phototherapy irradiation chamber with "substantial uniformity of irradiance" for treating skin conditions, using fluorescent lamps arranged to generally conform to a contoured surface. Blaisdell, which is incorporated by reference into Levin, was argued to disclose the necessary controller for the lamps, including ballast circuits and timers. Petitioner contended that Levin’s chamber, which achieves uniformity at various points including an 8-inch radius, meets the claimed distance limitations.
    • Motivation to Combine: A POSITA would combine the disclosures because Levin explicitly incorporates Blaisdell by reference for the details of constructing the phototherapy chamber. This direct link provides a clear motivation to read the teachings together as a single system.
    • Expectation of Success: Success would be highly expected, as the references were intended to be combined and describe different components of the same integrated phototherapy system.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including that claims 1-12 are obvious over Bower in view of POSITA knowledge; claims 1, 2, 5-7, 9, and 11-12 are obvious over Allen in view of POSITA knowledge; and claims 5, 6, and 10 are obvious over Allen in view of Lundahl and POSITA knowledge. These grounds relied on similar arguments about modifying base references with well-known components or techniques to achieve predictable results.

4. Key Claim Construction Positions

  • Petitioner argued that the term "illuminator" requires construction as "one or more light sources generally conforming to a contoured surface." This construction was based on intrinsic evidence, where the ’991 patent specification repeatedly disparages flat-emitting surfaces as unable to deliver a uniform light dose to a contoured area like a face. Petitioner asserted this disparagement amounts to a disavowal of flat illuminators, thus limiting the claim scope to contoured devices. A similar construction was proposed for "plurality of light sources."

5. Arguments Regarding Discretionary Denial

  • Petitioner argued that discretionary denial under §325(d) would be inappropriate. Although references such as Levin and Bower were cited in an Information Disclosure Statement (IDS) during prosecution, Petitioner contended the Examiner did not substantively review them, as the reasons for allowance focused on features that these references in fact disclose. Crucially, Petitioner also relied on primary references, including Rowland and Allen, that were never before the Examiner, meaning the petition raises new prior art and arguments not previously considered.

6. Relief Requested

  • Petitioner requests that the Board institute an inter partes review of claims 1-12 of the ’991 patent and cancel those claims as unpatentable.