PTAB

IPR2025-00287

Biofrontera Inc v. Sun Pharmaceutical Industries Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Adjustable Illuminator for Photodynamic Therapy and Diagnosis
  • Brief Description: The ’512 patent discloses a system and method for photodynamically treating skin conditions, such as actinic keratosis. The core technology is an illuminator comprising at least five panels connected by nested hinges, configured to provide uniform light distribution over a treatment area.

3. Grounds for Unpatentability

Ground 1: Claims 1-3, 5, 8, and 20 are obvious over Lundahl in view of Larsen.

  • Prior Art Relied Upon: Lundahl (Patent 6,223,071) and Larsen (Application # 2005/0075703).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Lundahl taught a photodynamic therapy (PDT) illuminator with a fixed U-shape designed for uniform illumination, notably by arranging fluorescent tubes with denser spacing near the edges to compensate for light drop-off. However, Lundahl's fixed shape and use of fluorescent tubes were known to have disadvantages. Larsen taught a PDT device using five hinged panels equipped with LEDs, allowing for flexible adjustment to fit various body parts like a patient's back. Petitioner asserted that combining Lundahl's light distribution principles with Larsen's adjustable, multi-panel LED structure would arrive at the claimed invention. For example, Larsen disclosed the five hinged panels (claim 1(a)), and Lundahl disclosed arranging light sources to create higher intensity near the panel edges (claim 1(f)).
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine Lundahl and Larsen to solve known problems with Lundahl's device. Specifically, a POSITA would be motivated to replace Lundahl's fixed U-shape with Larsen's hinged panels to improve flexibility for different patient anatomies and to replace Lundahl's fluorescent tubes with Larsen's LEDs for better cost, lifespan, and light output consistency.
    • Expectation of Success: A POSITA would have a reasonable expectation of success because both references described illuminators for treating skin conditions, and the proposed modifications involved combining known elements (hinges, LEDs) for their predictable functions.

Ground 2: Claims 1-3, 5, 8, 17, 18, and 20 are obvious over Lundahl in view of Larsen, and further in view of Hente.

  • Prior Art Relied Upon: Lundahl (Patent 6,223,071), Larsen (Application # 2005/0075703), and Hente (Application # 2010/0118522).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built upon the Lundahl/Larsen combination, adding Hente to provide additional teachings for the "nested hinges on inner side surfaces" and the "recess" limitations of claims 17 and 18. Hente taught a flexible, foldable lighting device with hinges positioned "between two rims of the first and the second section, facing each other," which Petitioner argued met the "nested hinge" limitation. Hente’s figures also showed a space or indentation between the panel rims configured to receive a flange of the hinge, thereby teaching the "recess" required by claims 17 and 18.
    • Motivation to Combine: A POSITA seeking to implement the hinged panel design from Larsen would look to references like Hente for methods of mounting hinges to minimize gaps and improve illumination uniformity. Hente explicitly taught placing hinges on the inner surfaces of adjacent panels to achieve a nearly flush arrangement, providing a direct motivation to incorporate this feature into the Lundahl/Larsen device.
    • Expectation of Success: The combination would have been successful because Hente operated in the same field of adjustable illuminators, and applying its hinge placement teachings was a predictable design choice to enhance the uniformity and functionality of a multi-panel device.

Ground 3: Claims 17 and 18 are obvious over Lundahl in view of Larsen, Hente, and further in view of Perutz.

  • Prior Art Relied Upon: Lundahl, Larsen, Hente, and Perutz (Patent 4,823,858).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground provided an alternative or additional basis for the obviousness of claims 17 and 18, which required a panel with a "recess" for receiving a hinge flange. Perutz, which related to a display panel system, explicitly taught a hinge system where ribs (flanges) on the hinges were received within slots (recesses) formed in the corners of adjacent panel frames. This was done to reduce space between panels and improve alignment.
    • Motivation to Combine: A POSITA designing the hinged illuminator of Lundahl/Larsen would be motivated to consult well-known mechanical arts, such as those shown in Perutz, for proven methods of connecting panels. The desire to minimize gaps between panels for continuous illumination would motivate a POSITA to adopt Perutz’s solution of using a recess to receive hinge flanges.
    • Expectation of Success: A POSITA would reasonably expect success in applying Perutz’s mechanical hinge-and-recess system to the illuminator panels, as it represented a straightforward application of a known mechanical principle to achieve a predictable result (a tighter fit between panels).

4. Key Claim Construction Positions

  • "recess": Petitioner argued that for claims 17 and 18, "recess" should be construed under its plain and ordinary meaning as "an indentation in a surface." This construction was central to the arguments that Hente and Perutz taught this limitation, as both showed indentations or spaces on a panel surface configured to receive a portion of a hinge.
  • Other Terms: For all other terms, Petitioner stated that for the purposes of the inter partes review (IPR), it adopted the Patent Owner's proposed constructions from related litigation to demonstrate obviousness even under the owner's interpretations.

5. Arguments Regarding Discretionary Denial

  • §325(d): Petitioner argued against discretionary denial, asserting that Hente and Perutz constituted new prior art never considered during prosecution. Furthermore, Petitioner contended that even though Lundahl and Larsen were before the examiner, the specific teachings relied upon and the arguments for their combination were not previously presented or considered. Petitioner claimed the examiner materially erred in allowing the claims over the prior art.
  • Fintiv: Petitioner noted that while the ’512 patent was involved in parallel ITC and District Court litigation, the District Court action was stayed. Citing the USPTO Director's guidance, Petitioner argued that discretionary denial under Fintiv is not applied to petitions challenging patents involved in parallel ITC proceedings.

6. Relief Requested

  • Petitioner requested the institution of an inter partes review and the cancellation of claims 1-3, 5, 8, 17, 18, and 20 of the ’512 patent as unpatentable.