PTAB

IPR2020-01573

New World Medical Inc v. MicroSurgical Technology Inc

Key Events

Petition

Title: Surgical Devices and Methods for Treating Glaucoma
Brief Description: The ’729 patent relates to methods and dual-blade devices for performing an ab interno goniectomy to treat glaucoma. The claimed procedure involves using a device with a bent distal tip and two cutting edges to enter the eye's anterior chamber and excise a strip of trabecular meshwork (TM) tissue from Schlemm’s Canal (SC) to improve aqueous humor outflow.

Prior Art Relied Upon: Quintana (a 1985 publication titled "Gonioscopic Trabeculotomy. First Results").
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Quintana, a reference not cited during prosecution, disclosed every element of the challenged claims. Quintana described an ab interno surgical procedure using a standard needle with a tip bent 20-30° to treat glaucoma. The procedure involved penetrating the anterior chamber, inserting the bent tip into Schlemm's Canal, and advancing it to "strip" a section of the TM. Petitioner contended that the beveled tip of Quintana’s needle, with its two opposing sharpened edges, inherently constituted the claimed "dual blade device." Furthermore, Petitioner asserted that the 30° bend disclosed in Quintana met the claim limitation requiring "a bend or curve having an angle of at least 30 degrees."

Prior Art Relied Upon: Quintana (1985 publication), Lee (Patent 4,900,300).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that to the extent the Board might find Quintana's needle does not constitute a "dual blade device," it would have been obvious to modify it based on the teachings of Lee. Lee explicitly disclosed a dual-bladed instrument with a U-shaped cutting edge designed for an ab interno procedure to excise TM tissue.
- Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine Lee's dual-blade cutting technology with Quintana's procedure for two primary reasons. First, to achieve more effective and complete removal of TM tissue to prevent post-surgical scarring and re-closure of the opening, a known problem that Lee was specifically designed to solve. Second, Lee provided the motivation of collecting larger, intact tissue samples for histopathological examination, which would have encouraged using a more capable excisional tool like Lee's.
- Expectation of Success: A POSITA would have a clear expectation of success in making this combination, as both references addressed the same technical problem (improving aqueous outflow via TM removal) using similar surgical approaches. Modifying a cutting instrument to improve its excisional capability was a predictable and well-understood design choice in the field.

Prior Art Relied Upon: Jacobi (a 1997 publication titled "Technique of goniocurettage").
Core Argument for this Ground:
- Prior Art Mapping: Petitioner asserted that Jacobi disclosed another complete embodiment of the invention through its "goniocurettage" procedure. Jacobi taught using a "gonioscraper" device in an ab interno approach to "abrade" and "peel" off "strings of trabecular tissue." Petitioner argued that the gonioscraper's bowl-shaped tip with sharpened circumferential edges constituted a "dual blade device." Citing figures from Jacobi and a related 2000 publication, Petitioner contended the device's convex-shaped arm and angled tip possessed the claimed "bend or curve having an angle of at least 30 degrees." The procedure of inserting this device through a corneal incision to remove TM tissue was alleged to teach all remaining limitations of the challenged claims.
Additional Grounds: Petitioner asserted additional obviousness challenges based on Quintana or Jacobi in view of the general knowledge of a POSITA. These grounds argued it would have been obvious to remove the excised tissue strip (claims 4-6) to prevent blockage and to modify the device's bend angle to suit surgical needs, including to approximately 90 degrees (claims 9-10).

"ab interno": Petitioner proposed this term means approaching the trabecular meshwork (TM) from within the anterior chamber, irrespective of the specific entry point through the outer eye (e.g., cornea, limbus, or sclera). This broad construction was argued to be supported by the intrinsic record and necessary to maintain the validity of dependent claim 7, which specifies a particular entry point (a corneal incision), under the doctrine of claim differentiation.
"dual blade device": Petitioner argued this term is not limited to needle-like devices but encompasses any instrument with two spaced-apart edges capable of cutting tissue. This construction was based on the prosecution history, where the patent examiner characterized the U-shaped cutting edge of the Lee reference as having "dual blades," thereby broadening the term's scope to include instruments like the bowl-shaped scrapers of Lee and Jacobi.

Petitioner argued that discretionary denial under §325(d) would be inappropriate for grounds relying on the Lee reference. Although Lee was cited during the patent's prosecution, Petitioner contended that it never formed the basis of any rejection and that the petition applied the reference in a new, substantively different manner than the examiner considered.

Petitioner requests institution of an inter partes review and cancellation of claims 1-10 of the ’729 patent as unpatentable.