PTAB

PGR2021-00026

MicroSurgical Technology Inc v. Regents Of University Of Colorado

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Intraocular device for dual incisions
  • Brief Description: The ’391 patent relates to a dual-blade microsurgical device and associated methods for treating eye diseases, such as glaucoma, using minimally invasive surgical techniques to incise the trabcular meshwork.

3. Grounds for Unpatentability

Ground 1: Lack of Written Description and Indefiniteness under §112

  • Core Argument for this Ground: Petitioner argued that claims 1-20 are unpatentable under 35 U.S.C. §112 because they rely on claim limitations introduced as "New Matter" that lacks written description support in, and is irreconcilable with, the patent’s original disclosure.
    • Prior Art Mapping: This ground is based on an internal analysis of the patent specification rather than prior art. Petitioner asserted that the challenged claims recite key elements such as a "distal member," a "right edge and a left edge extending towards the rearward end from the tip," and a "width between the right and left edges" that increases rearwardly. These terms appear only in two paragraphs of "New Matter" that Petitioner alleged were copied from an external source (Baerveldt) and inserted into the application from which the ’391 patent issued. Petitioner contended these terms conflict with the original disclosure, which consistently describes a "platform" with a "ramp" and parallel "lateral elements," not a "distal member" with diverging edges extending from the tip.
    • Key Aspects: Petitioner argued this conflict demonstrates that the inventors were not in possession of the claimed invention as of the purported priority date. This inconsistency also renders the claim scope unclear, making the claims indefinite. Furthermore, Petitioner argued that the limitation "the gap defining an unoccupied space that is not part of a lumen," added by the Examiner to overcome a rejection, also lacks written description support, as the specification does not describe or define a lumen in the relevant context.

Ground 2: Anticipation by Baerveldt under §102

  • Prior Art Relied Upon: Baerveldt (International Publication No. WO 2018/151808 A1).
  • Core Argument for this Ground: Petitioner argued claims 1-20 are anticipated by Baerveldt under 35 U.S.C. §102.
    • Prior Art Mapping: The core of this argument is that the challenged claims are not entitled to a priority date earlier than November 8, 2019—the date the "New Matter" was added to the application. Because Baerveldt was published on August 23, 2018, it qualifies as prior art. Petitioner asserted that the "New Matter" in the ’391 patent, which provides the only support for the challenged claims, was copied directly from the claims and specification of Baerveldt. Petitioner provided a detailed, element-by-element mapping showing that Baerveldt expressly discloses a method and device for incising trabecular meshwork comprising every limitation of independent claims 1 and 13, including a "distal member," a "forward tip," "right edge and a left edge progressing rearwardly," and a "cavity or open area rearward of the forward tip." Baerveldt was also shown to teach all limitations of the dependent claims, such as a concave bottom surface and the lifting of tissue away from Schlemm's canal.

Ground 3: Obviousness over Baerveldt under §103

  • Prior Art Relied Upon: Baerveldt (International Publication No. WO 2018/151808 A1).
  • Core Argument for this Ground: As an alternative to anticipation, Petitioner argued that claims 1-20 are obvious over Baerveldt under 35 U.S.C. §103.
    • Motivation to Combine (for §103 grounds): This ground is based on a single reference. Petitioner argued that Baerveldt teaches each and every element of the challenged claims in the same arrangement.
    • Expectation of Success (for §103 grounds): In the event any minor differences were perceived between Baerveldt and the challenged claims, Petitioner contended a person of ordinary skill in the art (POSITA) would have found that the general knowledge in the art was sufficient to bridge any gaps with a reasonable expectation of success.
    • Key Aspects: This ground relies on the same factual predicate as the anticipation ground: that the claims lack priority and Baerveldt is prior art that discloses the claimed invention.

4. Key Claim Construction Positions

  • "Tip": Petitioner proposed construing "tip" as "the point at the distal end of the device." This construction was used to highlight the conflict with the original disclosure, where cutting elements extend from a proximal "platform" rather than the distal "tip."
  • "Edge": Petitioner proposed construing "edge" as "a cutting structure." This supported the argument that the "right edge and left edge" of the claims are fundamentally different from the "lateral elements" described in the rest of the patent.
  • "Lumen": Petitioner proposed construing "lumen" as "the bore of a shaft." This construction was central to the argument that the negative limitation "not part of a lumen" lacks written description support, as the patent specification never describes a lumen in a context that could be distinguished from the claimed "gap."

5. Relief Requested

  • Petitioner requested institution of a post-grant review (PGR) and cancellation of claims 1-20 of the ’391 patent as unpatentable.