PTAB

IPR2022-01540

Ivantis Inc v. Sight Sciences Inc

Key Events

Petition

petition

Case #: IPR2022-01540
Patent #: 9,486,361
Filed: September 16, 2022
Petitioner(s): Ivantis, Inc., Alcon Research, LLC, Alcon Vision, LLC, and Alcon Inc.
Patent Owner(s): Sight Sciences, Inc.
Challenged Claims: 1-3 and 5-9

Title: Method for Reducing Intraocular Pressure
Brief Description: The ’361 patent discloses methods for treating glaucoma by implanting a support device into Schlemm’s canal of an eye. The support is designed to maintain the patency of the canal to improve the outflow of aqueous humor and thereby reduce intraocular pressure.

Prior Art Relied Upon: Tu (Application # 2005/0266047).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Tu discloses all elements of the challenged claims. Tu teaches methods and devices for reducing intraocular pressure by implanting a stent into Schlemm's canal using a delivery applicator. This applicator is a tubular cannula that can be introduced into the canal to both deliver the stent and inject a high-viscosity fluid like viscoelastic to dilate the canal. Tu's stents are described as supports comprising arcuate members (e.g., a "curved blade" or "center bulb") with a radius of curvature smaller than Schlemm's canal and at least one fenestration to prevent clogging. Petitioner contended Tu’s stents also meet the dependent claim limitations regarding contacting the canal wall, not interfering with fluid flow, and extending into the trabecular meshwork.
- Motivation to Combine (for §103 grounds): Not applicable as this is a single-reference ground. Petitioner argued a person of ordinary skill in the art (POSITA) would have recognized that Tu’s teachings render the claimed method obvious.
- Expectation of Success (for §103 grounds): A POSITA would have had a reasonable expectation of success in performing the claimed method, as Tu explicitly discloses using a combined delivery applicator for both viscoelastic and stent delivery to simplify stent insertion.

Prior Art Relied Upon: Gharib (Application # 2002/0165478) and Smedley (Patent 7,186,232).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner asserted that Gharib teaches the fundamental method of implanting a support with arcuate, fenestrated members into Schlemm's canal. Gharib's support is disclosed as having bifurcatable elements that are curved to conform to the canal and can be configured with various surfaces (mesh, porous, etc.) that constitute fenestrations. Smedley teaches an improved delivery apparatus (a tubular cannula with a plunger) that simplifies stent implantation and discloses injecting viscoelastic fluid to therapeutically dilate Schlemm's canal.
- Motivation to Combine (for §103 grounds): A POSITA would combine Smedley’s simplified, safer delivery apparatus with Gharib's support. Smedley's device reduces procedural steps and the number of foreign objects inserted into the eye. Combining this with viscoelastic delivery, as taught by Smedley, would clear blockages, dilate the canal, and facilitate the implantation of a support like Gharib's.
- Expectation of Success (for §103 grounds): A POSITA would have reasonably expected success because both references disclose similarly sized cannulas for trabecular microstents, and the combination addresses the known problem of collapsed or blocked canals, simplifying the procedure taught by Gharib.

Prior Art Relied Upon: Gharib (Application # 2002/0165478) and Haffner (Application # 2004/0102729).
Core Argument for this Ground:
- Prior Art Mapping: This ground is similar to Ground 2, with Gharib teaching the base support and method. Haffner is introduced as teaching a more advanced, single-device delivery apparatus that integrates stent implantation and viscodilation. Haffner's applicator includes features like a fluid infusing port and an injection sheath capable of storing and discharging stents, allowing a surgeon to perform both viscodilation and stent insertion in a single, simplified procedure.
- Motivation to Combine (for §103 grounds): A POSITA would be motivated to use Haffner's single, efficient delivery device to implant Gharib's support. This combination would achieve the shared goals of both references: a simple, effective, and minimally invasive outpatient procedure. The combination simplifies the surgery, reduces trauma and recovery time, and improves safety by minimizing the number of instruments entering the eye.
- Expectation of Success (for §103 grounds): Success would be expected because Haffner's advanced but similar apparatus is designed for delivering supports like Gharib's. The known benefits of viscodilation in glaucoma surgery would provide a strong expectation that using Haffner's device would successfully facilitate the implantation of Gharib's support.

"wherein at least a portion of the arcuate member has a radius of curvature smaller than a radius of curvature of Schlemm's canal": For the purposes of the petition, Petitioner adopted the Patent Owner's alleged interpretation that this limitation is met if an implanted support has an overall radius smaller than the canal such that a portion of the support protrudes from the canal.
"delivering a high viscosity fluid into Schlemm's canal": Petitioner adopted the Patent Owner's interpretation that all viscoelastic fluids are considered "high viscosity fluids" under the claim language.

§325(d) Factors: Petitioner argued against denial because the grounds rely on prior art references (Tu, Gharib, Smedley, Haffner) that were never applied or discussed by the examiner during the prosecution of the ’361 patent or its parent applications. Therefore, the arguments presented in the petition are dissimilar from those previously considered by the USPTO.
§314(a) Fintiv Factors: Petitioner argued for institution, stating that the petition presents a compelling unpatentability challenge. Further, the co-pending Delaware litigation, filed in September 2021, has a median time-to-trial that would place the trial date after the deadline for a Final Written Decision in this inter partes review (IPR). This timing weighs heavily in favor of institution, as the PTAB provides a more efficient avenue for resolving the validity dispute.

Petitioner requested the institution of an IPR and the cancellation of claims 1-3 and 5-9 of the ’361 patent as unpatentable.