Ivantis Inc v. Glaukos Corp

1. Case Identification

• Case #: IPR2019-00972
• Patent #: 6,626,858
• Filed: April 12, 2019
• Petitioner(s): Ivantis, Inc.
• Patent Owner(s): Glaukos Corp.
• Challenged Claims: 51-54, 56-57, 60, 61, 63, and 71

2. Patent Overview

• Title: Shunt Device and Method for Treating Glaucoma
• Brief Description: The ’858 patent discloses an aqueous humor shunt device for treating glaucoma by reducing elevated intraocular pressure. The device is designed to divert aqueous humor from the anterior chamber of the eye into Schlemm's canal, utilizing the eye's natural outflow pathways.

3. Grounds for Unpatentability

Ground 1: Obviousness over Spiegel and Grieshaber - Claims 51-54, 57, 60, 61, 63, and 71 are obvious over Spiegel in view of Grieshaber.

• Prior Art Relied Upon: Spiegel (Surgical Glaucoma Therapy, a 1998 book chapter) and Grieshaber (Australian Patent Application Publication AU 199876197).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Spiegel taught the core concept of independent claim 51: a shunt device made of a flexible material (silicone) for diverting aqueous humor from the anterior chamber into Schlemm's canal. Spiegel’s device inherently had a proximal portion for the anterior chamber, a distal portion for Schlemm's canal, and permitted fluid communication between them. However, Petitioner contended that Spiegel's simple tube did not explicitly disclose features permitting bi-directional fluid flow within Schlemm's canal. Grieshaber, which discloses various stent designs for implantation within Schlemm's canal, allegedly supplied these missing elements. Petitioner asserted that Grieshaber’s stents, with features like through-holes, recesses, gaps in a mesh structure, and a trough-like channel, explicitly taught how to create openings along an implant to permit bi-directional flow. Petitioner further argued that Grieshaber taught the specific dimensions and curved shapes required by dependent claims 52-54, 57, 60, 61, 63, and 71.
  • Motivation to Combine: Petitioner asserted that both Spiegel and Grieshaber addressed the identical problem of enhancing aqueous humor outflow by targeting Schlemm's canal. A person of ordinary skill in the art (POSITA), starting with Spiegel’s basic shunt concept, would combine it with the various implant designs in Grieshaber to optimize the device’s function within Schlemm's canal, such as by improving fluid distribution.
  • Expectation of Success: The combination involved applying known design features (openings, specific dimensions) from Grieshaber's stents to Spiegel's shunt. Petitioner argued these were simple design choices with predictable results, leading to a reasonable expectation of success.

Ground 2: Obviousness over Spiegel, Grieshaber, and Richter - Claim 56 is obvious over Spiegel in view of Grieshaber and in further view of Richter.

• Prior Art Relied Upon: Spiegel (Surgical Glaucoma Therapy), Grieshaber (Australian Patent Application Publication AU 199876197), and Richter (Patent 5,868,697).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground built upon the combination of Spiegel and Grieshaber to arrive at the base shunt device of claim 51. It added Richter to teach the additional limitation of claim 56, which requires the proximal portion to extend from the distal portion "at an angle to avoid occlusion" from the iris or cornea. Petitioner argued that Richter directly addressed the well-known problem of ophthalmic implants in the anterior chamber becoming clogged by iris tissue. Richter taught that the inlet end of the shunt should be designed to face away from the iris, such as by having a "beveled surface," to reduce the possibility of obstruction. Petitioner contended this teaching would have made it obvious to angle the proximal portion of the Spiegel/Grieshaber shunt to avoid contact with the iris and cornea.
  • Motivation to Combine: A POSITA creating the shunt taught by Spiegel and Grieshaber would confront the known and common problem of iris occlusion at the proximal end. Petitioner argued that the POSITA would be motivated to consult the prior art for a solution and would find it in Richter, which explicitly taught modifying the shunt's proximal end to prevent this exact issue.
  • Expectation of Success: Applying Richter's teaching—angling the proximal end—to the combined Spiegel/Grieshaber device was presented as a simple, predictable modification to solve a known problem, and thus a POSITA would have had a high expectation of success.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under §314(a) and §325(d) would be improper. Citing the General Plastic factors, Petitioner asserted that this petition challenged claims not included in its prior IPR filings against the ’858 patent. It further stated that the petition did not rely on previously withheld prior art and that the Board had not yet addressed the merits of the asserted references against any claims of the patent. Therefore, Petitioner contended that institution would not be an inefficient use of Board resources.

5. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 51-54, 56-57, 60, 61, 63, and 71 of Patent 6,626,858 as unpatentable under 35 U.S.C. §103.