PTAB

IPR2022-01529

Ivantis Inc v. Sight Sciences Inc

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1. Case Identification

2. Patent Overview

  • Title: Device for Reducing Intraocular Pressure
  • Brief Description: The ’443 patent discloses devices and methods for treating glaucoma. The invention involves implanting a stent-like support circumferentially within Schlemm’s canal of an eye to maintain its patency and improve the drainage of aqueous humor.

3. Grounds for Unpatentability

Ground 1: Obviousness over Gharib and Bergheim - Claims 1, 8, 11-12, 21, 23-24, 27, 42-43, 46, 52, 54-57 are obvious over Gharib, alone or in combination with Bergheim.

  • Prior Art Relied Upon: Gharib (Application # 2002/0165478) and Bergheim (Application # 2003/0060752).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Gharib taught all limitations of independent claim 1. Gharib disclosed a device with bifurcatable elements implanted into Schlemm’s canal to provide a "stenting capability" and maintain patency. Petitioner asserted that these elements are "arcuate members" that, once implanted, are configured to extend from Schlemm's canal into the trabecular meshwork, satisfying the claim requirement of having a smaller radius of curvature than the canal itself. For the limitation requiring the support to contact less than 30% of the canal's internal wall surface area, Petitioner argued that Gharib's disclosed dimensions and variety of non-circular cross-sectional shapes (e.g., D-shape, semi-circular) inherently meet this requirement. Calculations were provided to show that supports within Gharib's disclosed size ranges would fall below the 30% threshold.
    • Motivation to Combine: Petitioner contended that if Gharib alone was found insufficient, a person of ordinary skill in the art (POSITA) would combine it with Bergheim. Bergheim taught that increasing the porosity of ophthalmic implants by adding features like channels and troughs improves aqueous humor flow. A POSITA would combine Bergheim's concept of surface modification with Gharib's stent to further improve fluid drainage and reduce inflammation by minimizing surface area contact.
    • Expectation of Success: A POSITA would have a reasonable expectation of success because both references related to glaucoma implants and aimed to improve aqueous humor outflow. Combining known methods for reducing surface area (Bergheim) with a known stent structure (Gharib) was a predictable design optimization.

Ground 2: Obviousness over Lynch and Bergheim - Claims 1, 8, 11-12, 27, 42-43, 46, 52, 54-57 are obvious over Lynch, alone or in combination with Bergheim.

  • Prior Art Relied Upon: Lynch (Application # 2005/0038334) and Bergheim (Application # 2003/0060752).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued that Lynch also taught all limitations of claim 1. Lynch disclosed pre-curved, arcuate shunts for Schlemm's canal that could include a proximal portion extending into the anterior chamber, which Petitioner asserted met the limitation for a smaller radius of curvature that extends out of the canal. Lynch explicitly taught constructing supports from materials like mesh, or with fenestrations and trough-like structures, to facilitate fluid egress and prevent occlusion. Petitioner contended these teachings were aimed directly at reducing surface area contact to improve flow, thus disclosing the <30% contact area limitation.
    • Motivation to Combine: The motivation to combine Lynch with Bergheim was presented as analogous to the motivation for combining Gharib with Bergheim. A POSITA would be motivated to apply Bergheim’s teachings of adding channels or troughs to Lynch's fenestrated or mesh-based device to further optimize the design for reduced material contact and enhanced aqueous humor flow.
    • Expectation of Success: A POSITA would expect success in this combination for the same reasons as in Ground 1, as it involved combining well-understood principles for improving the performance of glaucoma drainage devices.

  • Additional Grounds: Petitioner asserted additional obviousness challenges based on combinations including Burns (for kit claims 58-59, 70-71) and Gharib (as a secondary reference to Lynch for claims 21, 23-24), relying on similar arguments for combining known features like delivery kits and shape memory materials.

4. Key Claim Construction Positions

  • "Internal wall surface area C, the support contacts less than 30% of C": Petitioner argued that the ’443 patent is vague on how to calculate this value. For the purpose of the inter partes review (IPR), Petitioner adopted the Patent Owner's interpretation, which allegedly assumes Schlemm's canal can be modeled as a simple, regular cylinder for the surface area calculation. Petitioner noted this contradicts the patent's own description of the canal as a "slightly arcuate cylinder" but proceeded with this interpretation to demonstrate obviousness.

5. Arguments Regarding Discretionary Denial

  • §325(d) (Becton Dickinson Factors): Petitioner argued against discretionary denial because the petition raised new grounds based on prior art that was not before the Examiner during prosecution. The primary references, Gharib and Lynch, were neither applied against the challenged claims nor discussed by the Examiner, meaning the arguments were not cumulative of those previously considered by the USPTO.
  • §314(a) (Fintiv Factors): The petition argued that discretionary denial under Fintiv would be inappropriate due to a co-pending district court litigation. Petitioner cited statistics showing the median time to trial in the relevant district (Delaware) was 971 days. This timeline placed the likely trial date after the statutory deadline for a Final Written Decision in the IPR, a factor that weighs strongly in favor of institution.

6. Relief Requested

  • Petitioner requests institution of an IPR and cancellation of claims 1, 8, 11-12, 21, 23-24, 27, 42-43, 46, 52, 54-59, and 70-71 as unpatentable.