PTAB

IPR2021-00452

Topcon Medical Systems Inc v. Carl Zeiss Meditec Inc

Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Combined Structure-Function Guided Progression Analysis
  • Brief Description: The ’251 patent describes methods for diagnosing ophthalmic diseases, such as glaucoma, by displaying combined structural and functional eye measurements over time. The invention focuses on generating a single viewport that presents data like optical coherence tomography (OCT) and visual field exam results side-by-side for comparative progression analysis.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 1-7, 10, 12-14, 18-23, 26-28, and 30 by Abe

  • Prior Art Relied Upon: Abe (a July 2016 journal article, "The Relative Odds of Progressing by Structural and Functional Tests in Glaucoma").
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Abe, a prior art printed publication, discloses every element of the challenged claims. Abe's Figure 3 explicitly shows a method of displaying combined structural (retinal thickness measurements from OCT) and functional (visual field measurements) disease progression information for a glaucoma patient. This information is presented side-by-side in a single view, arranged chronologically over a common time scale based on testing dates. Furthermore, Abe discloses a second side-by-side display of computed metrics (structural and functional trend lines), satisfying limitations found in dependent claims. The publication itself, being a viewable graphical representation, constitutes the claimed "viewport" and "display."

Ground 2: Claims 1-7, 10-15, 18-23, and 26-30 are obvious over Abe in view of Coelho

  • Prior Art Relied Upon: Abe (July 2016 journal article) and Coelho (Application # 2014/0293222).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that if the claims are construed to require a computerized system for performing the method steps (a construction Petitioner disputes), the combination of Abe and Coelho renders the claims obvious. Abe taught the specific content and layout of the claimed display, including side-by-side structural/functional data and metrics over time. Coelho taught a computerized system for displaying the exact same types of ophthalmic data (OCT, visual field tests) for diagnosing glaucoma, featuring a customizable user interface with widgets for displaying progression trend lines.
    • Motivation to Combine: A POSITA would combine Abe and Coelho to automate the clinically valuable display taught in Abe. Abe's study involved tracking numerous patients over multiple visits, making a manual or ad-hoc display generation process inefficient. A POSITA would have been motivated to use a robust, customizable computerized system like Coelho's to efficiently store, analyze, compute trends, and generate the combined structure-function displays shown in Abe for each patient.
    • Expectation of Success: The combination would yield predictable results. Both references operate in the same field of glaucoma monitoring and use the same data types. Implementing Abe's specific display layout using Coelho's flexible, computerized display system would be a straightforward application of known software design principles to improve clinical efficiency.

Ground 3: Claims 1-7, 10-15, 18-23, and 26-30 are obvious over Abe in view of Ono

  • Prior Art Relied Upon: Abe (July 2016 journal article) and Ono (Japanese Application Publication No. 2016-101297).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground presents an alternative obviousness combination, also premised on a potential requirement for a computerized system. Abe provided the blueprint for the claimed data display. Ono disclosed a computerized system for displaying structural and functional ophthalmic data in a side-by-side format to aid in glaucoma diagnosis. Ono specifically taught a system architecture for retrieving patient data from storage over a series of visits and using templates to generate reports, including trend lines and side-by-side image displays.
    • Motivation to Combine: A POSITA would have been motivated to use a system like Ono's to implement the display shown in Abe for the same reasons of efficiency and scalability cited for the Coelho combination. Ono’s system, with its focus on generating reports from historical patient data using templates, provided a clear and advantageous method for automating the production of the combined displays shown in Abe, especially in a clinical or research setting with many patients.
    • Expectation of Success: There was a high expectation of success, as Ono's system was expressly designed for generating the kinds of displays presented in Abe. The references are complementary, with Abe showing a desirable output and Ono providing a computerized system to produce it.

4. Key Claim Construction Positions

  • "displaying": Petitioner argued this term means "presenting to the user" and does not inherently require a "display device" like a computer screen. This construction is central to the anticipation argument (Ground 1), where the "display" is a figure within a published paper. Petitioner contended that Patent Owner’s contrary position improperly imports limitations from the specification.
  • "common time scale": Petitioner proposed this term be construed as "the same temporal arrangement for showing the relative or absolute passage of time." This construction supports the argument that the chronological arrangement of data in Abe, marked by dates, meets the limitation without requiring a formal, continuous time axis.
  • "structural measurement": Petitioner argued this term requires "a quantification," distinguishing it from mere images. This construction was used to show that the quantitative data in the prior art, such as retinal nerve fiber layer thickness, directly maps to the claims.

5. Arguments Regarding Discretionary Denial

  • Petitioner argued that the Board should not exercise its discretion to deny institution under 35 U.S.C. §314(a). The Fintiv factors were asserted to be inapplicable because the parallel district court litigation involving the ’251 patent had been dismissed. Consequently, Petitioner contended there was no risk of duplicative efforts or inconsistent rulings between the PTAB and a district court.

6. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-7, 10-15, 18-23, and 26-30 of the ’251 patent as unpatentable.