PTAB
IPR2019-00483
Ivantis Inc v. Glaukos Corp
Key Events
Petition
Table of Contents
petition
1. Case Identification
- Case #: IPR2019-00483
- Patent #: 9,827,143
- Filed: December 19, 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 (shunts or stents) and surgical methods for treating glaucoma. The devices are designed to be placed within Schlemm’s canal of the eye to maintain its patency and facilitate the drainage of aqueous humor, thereby reducing elevated intraocular pressure.
3. Grounds for Unpatentability
Ground 1: Claims 1, 3-8, 11-16, 20-24, 26-29, 31, and 38-42 are anticipated by or obvious over Grieshaber.
- Prior Art Relied Upon: Grieshaber (Australian Patent Application Publication AU 199876197).
- Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Grieshaber disclosed all limitations of the challenged claims. Specifically, the ocular implant shown in Grieshaber’s Figures 9 and 10, described as a support element for maintaining the patency of Schlemm's canal, met the key limitations of the independent claims. Petitioner contended this device comprised a body with longitudinal "webs" connecting two end rings, with open "recesses" between the webs. This structure was asserted to be "non-tubular" (per Petitioner’s construction) and possess "at least one opening along its length" (claim 1), a "partially open" channel (claim 5), and a "non-luminal" body (claim 38). Grieshaber's disclosure of using biocompatible materials like metal and its teaching that the implant can be pre-curved were mapped to limitations in other independent and dependent claims.
- Motivation to Combine (for §103 grounds): For claim limitations not explicitly disclosed but allegedly obvious, such as specific inner diameters (claims 24 and 41), Petitioner argued it would have been a matter of simple design choice for a person of ordinary skill in the art (POSITA). A POSITA would have designed the Grieshaber implant to fit within the known dimensions of Schlemm’s canal (190-370 micrometers), which falls within the claimed range of 100-500 micrometers. Similarly, modifying circular openings to be "ovoid" (claims 4, 8, 28, 39, 40) was presented as an obvious modification to enhance fluid flow.
Ground 2: Claims 2, 9, 10, 17-19, 25, and 32-37 are obvious over Grieshaber in view of Spiegel.
- Prior Art Relied Upon: Grieshaber (Australian Patent Application Publication AU 199876197) and Spiegel (Surgical Treatment of Glaucoma, 1998).
- Core Argument for this Ground:
- Prior Art Mapping: This ground combined Grieshaber's stent design with Spiegel's surgical method. Spiegel taught that the primary cause of elevated intraocular pressure is resistance in the trabecular meshwork and that an optimal solution is to bypass it. Spiegel described a surgical method of implanting a silicone tube by creating an incision in the trabecular meshwork, placing one end of the tube in Schlemm's canal and the other end in the anterior chamber. Petitioner argued this combination taught the limitations of method claim 32, including "creating an incision in a trabecular meshwork" and positioning a stent to be "partially located in an anterior chamber."
- Motivation to Combine: Petitioner contended a POSITA would combine these references to solve the known problem of trabecular meshwork obstruction. The motivation was to apply Spiegel's well-understood surgical approach—bypassing the meshwork to create a direct conduit from the anterior chamber—to the more advanced, open-structured stent design of Grieshaber. This would improve upon Spiegel’s simple tube by providing the superior stenting and drainage characteristics of Grieshaber's device.
- Expectation of Success: A POSITA would have a reasonable expectation of success because the combination involved applying a known surgical technique to an implant designed for the same anatomical location and therapeutic purpose.
Ground 3: Claim 30 is obvious over Grieshaber in view of Minckler.
- Prior Art Relied Upon: Grieshaber (Australian Patent Application Publication AU 199876197) and Minckler ("Hypothesis for Improving Accessory Filtration by Using Geometry," Journal of Glaucoma, 1994).
- Core Argument for this Ground:
- Prior Art Mapping: This ground addressed dependent claim 30, which required a stent with a cross-section that is "approximately semi-circular." Petitioner first argued this was obvious over Grieshaber alone, as modifying its three-web design to a two-web design for stability would result in larger, semi-circular panels. Alternatively, Petitioner argued Minckler rendered the modification obvious. Minckler explicitly taught a non-tubular, C-shaped ("trough-like") shunt with a semi-circular cross-section designed to prevent fibrous tissue build-up and occlusion by keeping one side entirely open.
- Motivation to Combine: A POSITA would have been motivated to modify Grieshaber’s stent design to incorporate Minckler’s semi-circular cross-section to gain the known benefits of improved drainage and reduced occlusion. Minckler addressed the same problem of shunt failure common in the field, making its teachings directly applicable to improving the Grieshaber device.
4. Key Claim Construction Positions
- "non-tubular" (claims 1, 12, 21, 24): Petitioner proposed the construction "not enclosed along its length." This was based on the specification's contrast of "tubular" with "enclosed geometry" against "non-tubular" with "trough-like" or "open" aspects. This construction was critical to mapping Grieshaber's open-webbed stent to the claims.
- "non-luminal" (claims 32, 38): Petitioner proposed the construction "not having an enclosed space or cavity." This was based on the specification's description of a lumen as an "enclosed space or cavit[y] defined by the walls" of the implant. This allowed Grieshaber’s stent, which lacks a fully enclosed cavity due to its "recesses," to be considered "non-luminal."
- "portal" (claims 5, 7-8, 38-40): Petitioner proposed the construction "an opening," based on the patent’s use of the term to describe various openings and fenestrations on the implant body.
5. Arguments Regarding Discretionary Denial
- Petitioner argued that discretionary denial under 35 U.S.C. §314(a) or §325(d) was inappropriate. This petition was a refiling of a previous petition (IPR2018-01180) that was denied institution solely because of a procedural error—Petitioner had inadvertently cited a non-prior art Australian patent instead of the correct, intended prior art Australian patent application (Grieshaber). Petitioner asserted that the Board never reached the substantive merits of the arguments or prior art. Citing the General Plastic factors, Petitioner argued that it had not withheld prior art, had not benefited from reviewing the Patent Owner's preliminary response in the first IPR, and was promptly refiling to correct the error. Therefore, institution would not be an inefficient use of Board resources or an improper "second bite at the apple."
6. Relief Requested
- Petitioner requested institution of an inter partes review and cancellation of claims 1-42 of Patent 9,827,143 as unpatentable under 35 U.S.C. §102 and/or §103.
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