PTAB

IPR2022-01530

Ivantis Inc v. Sight Sciences Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Devices for Reducing Pressure In an Eye
  • Brief Description: The ’742 patent discloses devices and methods for treating glaucoma by implanting a support circumferentially within Schlemm’s canal of an eye. The support is configured to maintain the patency of the canal, thereby improving the outflow of aqueous humor and reducing intraocular pressure.

3. Grounds for Unpatentability

Ground 1: Anticipation over Gharib - Claims 1-3, 6-9, 12, 15, and 17-20 are anticipated by Gharib under 35 U.S.C. §102.

  • Prior Art Relied Upon: Gharib (Application # 2002/0165478).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Gharib disclosed all limitations of the challenged claims. Gharib teaches a method for treating glaucoma by implanting a support with "two distal bifurcatable elements" within Schlemm's canal. These elements were described as arcuate members that prop open the canal. Petitioner contended that Gharib’s Figure 8 showed the support extending from Schlemm’s canal into the trabecular meshwork, thereby satisfying the key limitation of independent claim 1 requiring a portion of the arcuate member to have a radius of curvature smaller than that of Schlemm’s canal such that it extends out of the canal. Gharib also disclosed that the support could be made of shape-memory material (Nitinol), be porous, flexible, and have fenestrations, anticipating various dependent claims.

Ground 2: Anticipation over Grieshaber - Claims 1-3, 9, 12, 15, and 17-20 are anticipated by Grieshaber under 35 U.S.C. §102.

  • Prior Art Relied Upon: Grieshaber (Canadian Application # 2,244,646).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted Grieshaber disclosed a method of treating glaucoma by implanting a support to hold Schlemm's canal in an expanded position. The support was described as "longitudinally somewhat arcuate" and including a "collar" at one end that "fits closely against the inward face of [the] scleral incision," thus extending out of Schlemm’s canal. This structure was argued to meet the radius of curvature limitation of claim 1. Petitioner further argued Grieshaber disclosed all features of the challenged dependent claims, including a support with throughholes (fenestrations), a length of 2 mm (less than a quarter of the canal's circumference), and construction from biocompatible materials like stainless steel or a nickel-titanium alloy.

Ground 3: Obviousness over Grieshaber and Bergheim - Claim 13 is obvious over Grieshaber alone or in view of Bergheim under 35 U.S.C. §103.

  • Prior Art Relied Upon: Grieshaber (Canadian Application # 2,244,646) and Bergheim (Application # 2003/0060752).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground focused on claim 13’s limitation that the support contacts less than 30% of the internal wall surface area of Schlemm's canal. Petitioner argued that Grieshaber taught designs that inherently reduced surface contact, such as supports that are "conically tapered axially" or comprised of "axially spaced toruses" connected by narrow webs. A visual inspection of Grieshaber's Figure 10, showing a support with three webs, suggested a surface contact of approximately 25%.
    • Motivation to Combine: A POSITA would combine Grieshaber with Bergheim because Bergheim explicitly taught the benefits of increased device porosity to "facilitate efficient transport and/or transfusion of aqueous humor." Bergheim disclosed adding numerous channels or troughs to an implant's exterior to reduce surface area, improve flow, and reduce inflammation, providing a clear motivation to modify Grieshaber’s device to achieve the claimed low surface area contact.
    • Expectation of Success: A POSITA would have a reasonable expectation of success because both references taught improving aqueous outflow by creating openings and reducing material contact, making the optimization of surface area a predictable design choice.

  • Additional Grounds: Petitioner asserted additional challenges, including that claims were anticipated by Lynch (Application # 2005/0038334) and that various claims were obvious over combinations including Lynch, Gharib, and Burns (Application # 2004/0147870).

4. Key Claim Construction Positions

  • "Internal wall surface area C, the support contacts less than 30% of C": Petitioner noted the ’742 patent lacked clear guidance on how to measure or calculate this limitation. For the purpose of the IPR, Petitioner adopted the Patent Owner's interpretation from co-pending litigation, which estimated the surface area by treating Schlemm's canal as a "regular cylinder." Petitioner used this interpretation for its obviousness arguments for claim 13, despite noting that Schlemm's canal is not, in fact, cylindrical.

5. Arguments Regarding Discretionary Denial

  • §325(d) / Becton Dickinson Factors: Petitioner argued against discretionary denial because the primary references asserted (Gharib, Grieshaber, Lynch) were never applied against the claims or discussed by the Examiner during the prosecution of the ’742 patent or its parent applications. Therefore, the presented grounds were substantially different from those previously considered by the USPTO.
  • §314(a) / Fintiv Factors: Petitioner argued that institution would be efficient and fair despite a co-pending district court case in Delaware. It asserted that the median time to trial in Delaware (971 days) placed the likely trial date in May 2024, well after the statutory deadline for a Final Written Decision in this IPR (March 2024). This timeline weighed heavily in favor of institution, as the PTAB could resolve patentability more quickly than the district court.

6. Relief Requested

  • Petitioner requested the institution of an inter partes review and cancellation of claims 1-3, 6-9, 12-13, 15, and 17-20 of the ’742 patent as unpatentable.