Hologic Inc v. University Of South Florida Board Of Trustees

1. Case Identification

• Case #: IPR2021-00656
• Patent #: 6,630,937
• Filed: March 18, 2021
• Petitioner(s): Hologic, Inc., Varex Imaging Corp., Mevis Medical Solutions AG
• Patent Owner(s): University of South Florida Board of Trustees
• Challenged Claims: 2-6, 9-11, 16-17

2. Patent Overview

• Title: Grayscale Mammography Workstation and Method
• Brief Description: The ’937 patent discloses a system and method for a medical imaging workstation, specifically designed for displaying and manipulating digitized mammograms. The system features an interface for providing various display forms of a mammogram, including different grayscale values and resolutions, across one or more monitors.

3. Grounds for Unpatentability

Ground 1: Anticipation by Stewart - Claims 2-6, 9-11, and 16-17 are anticipated by Stewart.

• Prior Art Relied Upon: Stewart (a March 1993 article in IEEE Engineering in Medicine and Biology Magazine titled “Clinical Utilization of Grayscale Workstations”).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Stewart, a 1993 publication, discloses every element of the challenged claims. Stewart describes high-resolution grayscale workstations used in radiology departments for displaying digital images, including mammograms. The disclosed system includes multiple high-resolution monitors, a processor (Sun SPARCstation), electronic storage (high-speed disk array), and user input devices (mouse, trackball, dials). Petitioner contended Stewart’s workstation performs the claimed functions, such as displaying images in multiple windows, allowing user manipulation of grayscale values ("window and level" controls), zooming, making measurements via a "graphic overlay generator," and documenting a diagnosis. The system stores images with a greater bit depth (12-bit) than can be displayed (8-bit), inherently requiring transformation into different forms for display, which Petitioner asserted meets the key limitations of independent claims 2, 3, and 17.

Ground 2: Obviousness over Freedman and Cade - Claims 2-6, 9-11, and 16-17 are obvious over Freedman in view of Cade.

• Prior Art Relied Upon: Freedman (a 1994 annual report titled “MDIS Compatibility: Computer Assisted Quality Control and Telemammography”) and Cade (a November 1993 article in Administrative Radiology titled “MDIS: The New Standard in Filmless Imaging”).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that Freedman describes a mammography workstation specifically designed for the Medical Diagnostic Imaging Support (MDIS) system. This workstation includes four high-resolution monitors, local and archive storage, a mouse-driven graphical user interface (GUI), and numerous image manipulation functions. These functions include selecting images for display, rearranging images across monitors, displaying images according to a default protocol, controlling grayscale "windowing and leveling," zooming via a "digital magnifying glass," taking measurements, and using reporting software. To the extent Freedman does not explicitly detail the processor or system architecture, Petitioner argued Cade provides this context by describing the overall MDIS system, which includes an "Image Display Subsystem" with workstations, a centralized Work Storage Unit, and an Optical Disk Jukebox for long-term storage, all interconnected.
  • Motivation to Combine: Petitioner argued a person of ordinary skill in the art (POSITA) would combine Freedman and Cade because Freedman explicitly states its purpose is to describe the requirements for an "MDIS compatible" mammography workstation. Cade provides the architectural overview of the MDIS system itself. Therefore, a POSITA would naturally have looked to the workstation detailed in Freedman as the "Image Display Subsystem" component within the broader MDIS system described by Cade.
  • Expectation of Success: A POSITA would have had a high expectation of success in combining the teachings, as the Freedman workstation was expressly designed to be compatible with and interface to the MDIS system described in Cade.

4. Key Claim Construction Positions

• Petitioner argued that several challenged claims contain means-plus-function limitations under 35 U.S.C. §112(6) that are critical to the invalidity analysis. Key proposed constructions included:
  • "means controllable by a signal from the user-operable device for transforming the image into a plurality of varying-resolution forms" (claims 3, 17): Petitioner proposed the function is "transforming the image into a plurality of varying-resolution forms" and the corresponding structure is "a workstation processor performing the algorithm of Figure 3, and equivalents."
  • "means for displaying the forms on the display means, each form displayed within a different sector of the display means" (claim 3): Petitioner proposed the function is "displaying the forms on the display means..., each form displayed within a different sector..." and the structure is "a workstation processor performing the algorithm of Figure 3, and equivalents."
  • Petitioner asserted these constructions are supported by the patent's specification and that the prior art discloses the corresponding structures performing the claimed functions.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that the Board should not exercise discretionary denial under Fintiv for several reasons:
  • The district court trial was scheduled for December 2022, meaning a Final Written Decision (FWD) would issue several months prior to trial, weighing against denial.
  • At the time of filing, investment in the parallel litigation was minimal, as significant discovery and claim construction were scheduled to occur after the IPR institution deadline.
  • The invalidity grounds presented in the IPR petition were distinct from other grounds (e.g., public use) raised in the district court, minimizing overlap and concerns of duplicative efforts.
  • Petitioner contended the merits of the petition were exceptionally strong, presenting clear anticipation and obviousness challenges, which heavily weighs in favor of institution.

6. Relief Requested

• Petitioner requested the Board institute an inter partes review and cancel claims 2-6, 9-11, and 16-17 of the ’937 patent as unpatentable.