New World Medical Inc v. Regents Of University Of California

1. Case Identification

• Case #: IPR2021-00066
• Patent #: 9,999,544
• Filed: October 20, 2020
• Petitioner(s): New World Medical, Inc.
• Patent Owner(s): The Regents of the University of California
• Challenged Claims: 1-11

2. Patent Overview

• Title: Devices and Methods for Glaucoma Treatment
• Brief Description: The ’544 discloses devices and methods for performing a goniectomy, a surgical procedure to treat glaucoma. The invention relates to an elongate surgical instrument with a probe shaft and a distal "foot member" set at an angle, which is used to create an opening in the trabecular meshwork (TM) of the eye to improve aqueous humor outflow.

3. Grounds for Unpatentability

Ground 1: Anticipation over Quintana - Claims 1-11 are anticipated by Quintana under 35 U.S.C. §102.

• Prior Art Relied Upon: Quintana (a 1985 publication titled Gonioscopic Trabeculotomy. First Results).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that under the broad construction advocated by the Patent Owner in co-pending litigation, Quintana anticipates all challenged claims. Quintana described an ab interno goniotrabeculotomy procedure using a standard needle with its tip bent at a 20-30° angle to "strip" a section of the TM. Petitioner argued this bent-tip needle is an "elongate surgical instrument" with a "probe shaft" (the needle body) and a "foot member" comprising a "platform" (the bent tip). The procedure disclosed in Quintana—inserting the needle tip into the anterior chamber, through the TM, and advancing it within Schlemm's Canal (SC)—was argued to meet all limitations of method claims 8-11.
  • Key Aspects: This ground relied on the premise that a standard bent needle, a static-mechanical cutting device, falls within the scope of the claims, a position Petitioner contended the Patent Owner has taken elsewhere.

Ground 2: Obviousness over Quintana and POSITA Knowledge - Claims 1-11 are obvious over Quintana in view of the general knowledge of a POSITA under 35 U.S.C. §103.

• Prior Art Relied Upon: Quintana (1985 publication) and knowledge of a Person of Ordinary Skill in the Art (POSITA), including references like Moses (a 1971 publication on electrocautery) and Peyman (Patent 4,099,529).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground was presented as an alternative, assuming a narrower claim construction limited to tissue-ablating or dynamic-mechanical cutting mechanisms (as disclosed in the ’544 patent). Petitioner argued Quintana taught the foundational device: a surgical instrument with an angled tip for performing an ab interno procedure to remove TM tissue. The only difference was that Quintana's needle used static cutting edges.
  • Motivation to Combine: A POSITA would have been motivated to modify Quintana’s device by replacing its static cutting edges with other well-known mechanisms for removing TM tissue, such as the electrocautery element from Moses or a dynamic-mechanical cutter. The motivation was to substitute one known cutting element for another within a known surgical approach to achieve the same result of creating a permanent opening in the TM. For example, a POSITA could have modified Quintana's needle to create a bipolar electrode, as taught by Moses, for use in the same ab interno procedure.
  • Expectation of Success: A POSITA would have had a high expectation of success because combining known elements (an existing surgical tool and a known cutting/ablating technology) for their intended purposes would have yielded predictable results.

Ground 3: Obviousness over Jacobi and POSITA Knowledge - Claims 1-11 are obvious over Jacobi in view of the general knowledge of a POSITA under §103.

• Prior Art Relied Upon: Jacobi (a 1997 publication on goniocurettage), knowledge of a POSITA, and references like Moses and Lee (Patent 4,900,300).
• Core Argument for this Ground:
  • Prior Art Mapping: Jacobi disclosed an ab interno "goniocurettage" procedure using a "gonioscraper" to "peel" off "strings of trabecular tissue." Petitioner argued the gonioscraper—which had a handle, a convex-shaped arm, and a bowl-like tip with sharpened edges—was an "elongate surgical instrument" with a "probe shaft" and an angled "foot member" (the bowl-shaped tip), thereby teaching the core structure of the claimed device. The procedure was also analogous to the claimed method.
  • Motivation to Combine: Similar to Ground 2, a POSITA would have been motivated to modify Jacobi’s static-cutting gonioscraper by incorporating a known tissue-ablating or dynamic-mechanical cutting mechanism. Further, if the Board found Jacobi's tip did not teach the "trabecular meshwork slides over the upper side" limitation of claim 2, a POSITA would have been motivated to modify it based on Lee, which taught a device with a protruding tip to ensure tissue passed over the cutting surface for "ease of tissue penetration and cutting."
  • Expectation of Success: A POSITA would have expected success in substituting one known TM removal mechanism for another on Jacobi's device, or in making a simple structural modification like that taught by Lee to improve functionality, as it involved applying known principles to achieve predictable outcomes.

4. Key Claim Construction Positions

• "device useable to create an opening..." / "facilitate performance of a surgical procedure...": Petitioner argued these functional phrases should be construed narrowly in light of the specification. The ’544 patent only disclosed two specific mechanisms for creating an opening: (1) tissue-ablating mechanisms (e.g., cautery, laser) and (2) dynamic-mechanical cutting mechanisms (e.g., rotating or guillotine-type blades). Petitioner contended the claims should be limited to these disclosed mechanisms and should not cover devices that use static-mechanical cutting (e.g., a simple fixed blade or sharpened needle), which were well-known in the prior art. This construction was central to Petitioner's alternative obviousness arguments in Grounds 2 and 3.
• "ab interno": Petitioner argued this term should be construed to mean a procedure where the TM is approached from within the anterior chamber of the eye, regardless of the precise entry point (cornea, limbus, or sclera). This construction supported the argument that the prior art procedures taught by Quintana and Jacobi were analogous to the claimed methods.

5. Relief Requested

• Petitioner requested institution of an inter partes review and cancellation of claims 1-11 of Patent 9,999,544 as unpatentable.