PTAB
IPR2018-01180
Ivantis, Inc. v. Glaukos Corporation
1. Case Identification
- Patent #: 9,827,143
- Filed: May 30, 2018
- Petitioner(s): Ivantis, Inc.
- Patent Owner(s): Glaukos Corp.
- Challenged Claims: 1-42
2. Patent Overview
- Title: Shunt Device and Method for Treating Ocular Disorders
- Brief Description: The ’143 patent discloses ocular implants (stents) and surgical methods for treating glaucoma. The technology is designed to relieve elevated intraocular pressure by creating a fluid pathway to divert aqueous humor from the anterior chamber of the eye into Schlemm’s canal, utilizing the eye’s natural outflow pathways. A central aspect of the challenged claims is that the implant body is "non-tubular," "non-luminal," or has a channel that is at least "partially open," distinguishing it from prior art solid-walled tubular shunts.
3. Grounds for Unpatentability
Ground 1: Anticipation and/or Obviousness over Grieshaber - Claims 1, 3-8, 11-16, 20-24, 26-29, 31, and 38-42 are anticipated or obvious over Grieshaber.
- Prior Art Relied Upon: Grieshaber (Australian Application # 199876197).
- Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Grieshaber, which discloses an indwelling ocular implant for treating glaucoma by stenting Schlemm's canal, anticipates all limitations of the independent claims. Specifically, the embodiment shown in Grieshaber's Figures 9 and 10 depicts a "support element" comprising two end rings connected by longitudinal "webs" with large "recesses" (openings) between them. Petitioner contended this structure is inherently "non-tubular" (i.e., not enclosed along its length) and "non-luminal" (i.e., lacking an enclosed cavity). The recesses constitute the claimed "openings" or "portals" that facilitate aqueous humor passage. Grieshaber also taught that the implant could be curved ("somewhat arcuate") to match the anatomy of Schlemm's canal and could be made of metal, mapping to limitations in various dependent claims.
- Motivation to Combine (for §103 grounds): As an alternative to anticipation, Petitioner argued that any minor differences would have been obvious. For example, selecting a specific diameter within the claimed range of 100-500 micrometers was an obvious design choice, as Grieshaber disclosed a 200 micrometer diameter and the average diameter of Schlemm's canal was known to be 190-370 micrometers.
- Key Aspects: This ground's strength relies on the construction of the negative limitations "non-tubular" and "non-luminal" to read on Grieshaber's open-sided, web-and-recess structure.
Ground 2: Obviousness over Grieshaber in view of Spiegel - Claims 2, 9, 10, 17-19, 25, and 32-37 are obvious over Grieshaber in view of Spiegel.
- Prior Art Relied Upon: Grieshaber (Australian Application # 199876197) and Spiegel (Surgical Treatment of Glaucoma, 1998).
- Core Argument for this Ground:
- Prior Art Mapping: This ground primarily addresses the method claims and limitations requiring a portion of the implant to be positioned in the anterior chamber. Petitioner asserted that Grieshaber provided the "non-luminal open stent" as established in Ground 1. Spiegel, which addresses the same problem of improving aqueous outflow, taught a surgical method of bypassing a compromised trabecular meshwork by inserting a silicone tube through an incision in the meshwork. This tube was placed with one end seated in Schlemm's canal and the other end extending into the anterior chamber, directly teaching the claimed surgical positioning.
- Motivation to Combine (for §103 grounds): A POSITA would combine the Grieshaber stent with the Spiegel surgical method to solve the known problem of bypassing the trabecular meshwork. It would have been an obvious and logical step to use Spiegel's well-understood surgical placement technique to install a more advanced, non-occluding stent like Grieshaber's, thereby providing a direct conduit from the anterior chamber into Schlemm's canal.
- Expectation of Success: A POSITA would have had a high expectation of success, as the combination involved applying a known surgical technique to a known type of implant to address a well-documented problem in ophthalmology.
Ground 3: Obviousness over Grieshaber in view of Minckler - Claim 30 is obvious over Grieshaber in view of Minckler.
- Prior Art Relied Upon: Grieshaber (Australian Application # 199876197) and Minckler (Hypothesis for Improving Accessory Filtration by Using Geometry, 1994).
- Core Argument for this Ground:
- Prior Art Mapping: This ground targets dependent claim 30, which requires the implant to have an "approximately semi-circular" cross-section. Grieshaber's primary embodiment shows three webs; Petitioner argued it would be an obvious design choice to use only two webs, creating larger panels that would form a semi-circular support structure. Alternatively, Minckler explicitly taught that a non-tubular shunt with a "C-shaped cross section" (i.e., a semi-circular, trough-like tube) offered functional advantages by providing a large, open filtering surface that minimizes fibrous build-up and occlusion.
- Motivation to Combine (for §103 grounds): A POSITA would be motivated to modify Grieshaber's stent by incorporating Minckler's teaching of a semi-circular cross-section. The motivation was to enhance the functional benefits of Grieshaber’s open design by adopting a shape known to promote drainage and prevent occlusion, a common failure mode for ocular shunts.
- Expectation of Success: Success would be expected, as it involved incorporating a known, advantageous geometric shape (from Minckler) into a similar device (Grieshaber) to improve its performance in a predictable way.
4. Key Claim Construction Positions
- "non-tubular" (claims 1, 12, 21, 24): Petitioner proposed this term means "not enclosed along its length." This construction was based on the specification contrasting "tubular" with open, "trough-like" channels and was central to arguing that Grieshaber's web-and-recess design meets the limitation.
- "non-luminal" (claims 32, 38): Petitioner proposed this term means "not having an enclosed space or cavity." This was based on the specification associating "lumens" with enclosed spaces within tubular elements. This construction allowed Grieshaber's open structure, which lacks a fully enclosed cavity, to be characterized as "non-luminal."
- "portal" (claims 5, 7-8, 38-40): Petitioner argued this term should be construed simply as an "opening." This broad construction was supported by the patent's varied use of the term to describe different types of openings and was necessary to map the term to the "recesses" or "throughholes" in Grieshaber.
5. Key Technical Contentions (Beyond Claim Construction)
- Priority Date Entitlement: Petitioner dedicated significant argument to establishing that the ’143 patent was not entitled to its claimed 1999 provisional priority date. Petitioner asserted that the provisional application failed to provide written description support for the key "non-tubular," "non-luminal," and "partially open" limitations. These concepts allegedly first appeared in the non-provisional application filed in April 2000. This contention was critical because it established Grieshaber (published February 1999) as §102(b) prior art.
6. Relief Requested
- Petitioner requested institution of an inter partes review and cancellation of claims 1-42 of the ’143 patent as unpatentable.