PTAB

IPR2018-01448

Jubilant DraxImage Inc v. Bracco Diagnostics Inc

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1. Case Identification

2. Patent Overview

  • Title: Computer-Controlled Safety Systems for Radiopharmaceuticals
  • Brief Description: The ’468 patent describes a mobile radioisotope infusion system used to generate and administer rubidium-82 eluate to patients. The system features a computer-controlled safety protocol that performs automated "breakthrough testing" on the eluate to detect strontium contamination and prevents patient infusion if results exceed a predetermined safety limit.

3. Grounds for Unpatentability

Ground 1: Obviousness over Klein, Reilly, and Tate - Claims 1-2, 4, 6-7, 9-17, 19, 24-25, and 28 are obvious over Klein, Reilly, and Tate.

  • Prior Art Relied Upon: Klein (a 2007 thesis), Reilly (Application # 2004/0260143), and Tate (Application # 2008/0177126).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Klein, a thesis describing a prototype rubidium-82 infusion system, taught nearly all limitations of the independent claims, including a computer on a movable cart that controls the system and prevents patient infusion if a breakthrough test fails. However, Klein’s system used an off-cart dose calibrator. Petitioner contended that Reilly and Tate remedied this deficiency, as both taught radiopharmaceutical carts that integrate the dose calibrator and its shielding directly onto the movable platform for user convenience and to create a self-contained unit.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine these references to improve upon Klein’s academic prototype for commercial application. Integrating the off-cart dose calibrator onto the mobile platform, as taught by Reilly and Tate, was presented as an obvious design choice to create a more user-friendly, self-contained, and marketable medical device.
    • Expectation of Success: A POSITA would have a high expectation of success, as dose calibrators were well-known, commercially available components with predictable performance, and their integration into a mobile cart was a known and straightforward practice.

Ground 2: Obviousness over Klein, Reilly, Tate, and Bracco Manual - Claim 8 is obvious over Klein, Reilly, Tate, and the Bracco Manual.

  • Prior Art Relied Upon: Klein (a 2007 thesis), Reilly (Application # 2004/0260143), Tate (Application # 2008/0177126), and the Bracco Manual (a 2004 user guide).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built upon the combination in Ground 1. Petitioner asserted that while the base combination taught the system of claim 1, it did not explicitly teach a printer for quality control information as required by dependent claim 8. The Bracco Manual, a user guide for an existing commercial infusion system, was introduced to teach the routine practice of printing logs and reports of system calibration and elutions for record-keeping.
    • Motivation to Combine: A POSITA would combine the Bracco Manual's teachings with the Klein/Reilly/Tate system because maintaining written records of testing and calibration is a routine and critical practice for medical devices. The Bracco Manual demonstrated an existing industry practice for the same type of device, providing a clear reason to add a printing function for quality control documentation.
    • Expectation of Success: Success was predictable, as adding a printer to a computer-controlled system to generate reports is a standard and simple function involving common hardware and software.

Ground 3: Obviousness over Klein, Reilly, Tate, and Hirschman - Claims 18, 20, and 27 are obvious over Klein, Reilly, Tate, and Hirschman.

  • Prior Art Relied Upon: Klein (a 2007 thesis), Reilly (Application # 2004/0260143), Tate (Application # 2008/0177126), and Hirschman (Application # 2011/0178359).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground again built upon the base combination of Ground 1 to address data handling features in claims 18 (encoded information reader), 20, and 27 (transferring data to removable storage). Petitioner argued Hirschman taught using features like bar code or RFID readers to input data from system components and writing quality control data to removable media like a USB memory stick.
    • Motivation to Combine: A POSITA would incorporate Hirschman's teachings to improve the data management and workflow efficiency of the base system. Automating data entry with readers reduces human error, and using removable storage enhances data portability and backup capabilities, which were widely recognized advantages in medical device design at the time.
    • Expectation of Success: Combining these common data handling technologies was argued to be routine, involving standard hardware and software interfaces with a high expectation of success.
  • Additional Grounds: Petitioner asserted an additional obviousness challenge for claims 5 and 26 based on the primary combination in view of Hirschman and Jackson (Application # 2008/0242915), arguing it would have been obvious to add the capability to automatically transfer quality control data to a remote computer or network for centralized storage and monitoring.

4. Relief Requested

  • Petitioner requests the institution of an inter partes review and the cancellation of claims 1-2, 4-19, and 24-28 of Patent 9,299,468 as unpatentable.