Ivantis, Inc. v. Glaukos Corporation

1. Case Identification

• Case #: IPR2019-00475 (referenced as related pending case), IPR2018-01147 (referenced as related denied case). The petition is for a new, unassigned IPR.
• 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 a shunt device and method for treating glaucoma by decompressing elevated intraocular pressure. The device diverts aqueous humor from the anterior chamber of the eye directly into Schlemm's canal to utilize the eye's natural outflow pathways.

3. Grounds for Unpatentability

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

• Prior Art Relied Upon: Spiegel (Detlev Spiegel, Surgical Glaucoma Therapy book chapter, 1998) and Grieshaber (Australian Patent Application Publication AU 199876197).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Spiegel taught the fundamental concept of the claimed invention: a shunt device to treat glaucoma by bypassing the trabecular meshwork. Spiegel disclosed an indwelling, flexible silicone tube with a proximal end in the anterior chamber and a distal end seated in Schlemm's canal to create a direct fluid connection. While Spiegel provided the basic structure, Grieshaber provided specific design features that would render the various dependent claims obvious. For claim 51, which requires a flexible material and bi-directional flow, Petitioner asserted that Spiegel’s silicone tube met the flexibility requirement, and Grieshaber taught various ocular stent designs (e.g., with openings at both ends and along the sides) that inherently permit bi-directional flow within Schlemm’s canal. For dependent claims, Petitioner mapped Grieshaber’s teachings to specific limitations, such as dimensional ranges for the shunt's diameter and length (claims 52, 57, 60, 61), a pre-formed curvature to match Schlemm's canal (claims 53, 54), fenestrations to allow fluid passage (claim 63), and a trough-like channel structure (claim 71).
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine Spiegel and Grieshaber because both references addressed the identical problem of improving aqueous humor outflow by creating a pathway into Schlemm's canal. Petitioner contended that a POSITA seeking to implement Spiegel's conceptual shunt would have naturally looked to Grieshaber, which disclosed a variety of detailed, practical designs for stents intended for the same anatomical location and purpose. Grieshaber’s designs represented known options for improving upon Spiegel's basic tube.
  • Expectation of Success: A POSITA would have had a reasonable expectation of success because combining the references involved implementing known design choices (e.g., adding openings, adjusting dimensions) for a glaucoma shunt, a well-established field of art.

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

• Prior Art Relied Upon: Spiegel, Grieshaber, 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 address dependent claim 56, which requires the shunt's proximal portion to extend from the distal portion "at an angle to avoid occlusion from contact with... iris tissue." Petitioner argued that while Spiegel and Grieshaber provided the basic shunt, Richter taught the specific solution to the problem of iris occlusion. Richter explicitly recognized that shunts placed in the anterior chamber "tend to clog over time... by tissue, such as the iris, being sucked into the inlet." To solve this, Richter taught designing the inlet with a "beveled surface" or an "angled" tip to face away from the iris. This directly corresponds to the "at an angle" limitation in claim 56.
  • Motivation to Combine: Petitioner asserted that iris occlusion was a well-known problem for any device with an inlet in the anterior chamber, as acknowledged in the ’858 patent itself. A POSITA implementing the shunt of Spiegel and Grieshaber would have recognized this potential for failure and been motivated to find a solution. Richter provided an elegant and known solution for this exact problem. Therefore, a POSITA would have been motivated to modify the proximal end of the Spiegel/Grieshaber shunt with the angled inlet taught by Richter to improve its reliability and avoid a known failure mode.
  • Expectation of Success: The modification was a simple design choice to solve a known problem, using a disclosed technique from a related device. As such, a POSITA would have had a high expectation of success in incorporating Richter's angled tip into the combined Spiegel/Grieshaber device.

4. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial under §314(a) and §325(d) would be improper. It asserted that the petition satisfied the General Plastic factors favoring institution. Specifically, Petitioner noted that although it had filed previous IPRs against the ’858 patent, this petition challenged a different set of claims that the Board had not previously considered on the merits. Furthermore, Petitioner argued it was not relying on previously withheld prior art or arguments retooled in response to a Patent Owner Preliminary Response, as this petition was filed before any such response in a related pending case.

5. Relief Requested

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