PTAB

IPR2018-01450

Jubilant DraxImage Inc v. Bracco Diagnostics Inc

Log In
Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Computer-Controlled Radiopharmaceutical Safety Systems
  • Brief Description: The ’468 patent discloses computer-controlled safety systems for radioisotope generators. The invention focuses on performing automated "breakthrough testing" of a radioactive eluate to detect strontium contamination and is configured to prevent patient infusions if the test results exceed an allowable limit.

3. Grounds for Unpatentability

Ground 1: Anticipation of Claims 21 and 23 - Claims 21 and 23 are anticipated by Klein under 35 U.S.C. §102.

  • Prior Art Relied Upon: Klein (“Precise 82Rb Infusion System for Cardiac Perfusion Measurement Using 3D Positron Emission Tomography,” a 2005 student thesis).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Klein discloses every limitation of independent claim 21, which recites a mobile radioisotope generator system. Klein described a computer-controlled rubidium-82 infusion system on a stainless-steel cart, which includes a shielded generator, an activity counter (the claimed "means for measuring activity"), and a dose calibrator (the claimed "means for receiving eluate... and measuring breakthrough activity"). Most critically, Petitioner asserted that Klein taught the key limitation of preventing patient infusion if a quality control test fails. Klein stated its computer software "must ensure that the protocol is followed" and that "patient elutions are enabled only after the prerequisites have been completed successfully," which includes a daily breakthrough test. Petitioner further contended that dependent claim 23, which adds a waste reservoir and a divergence valve to divert eluate, was also anticipated. Klein’s system was described as routing the initial eluate flow to a waste container until a threshold activity is reached, thereby teaching the claimed elements.

Ground 2: Obviousness of Claim 22 - Claim 22 is obvious over Klein in view of Hirschman and Jackson under 35 U.S.C. §103.

  • Prior Art Relied Upon: Klein (a 2005 student thesis), Hirschman (Application # 2011/0178359), and Jackson (Application # 2008/0242915).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that claim 22, which depends from claim 21, adds the limitation that the control system is configured to "electronically transfer quality control test information and infusion information to one or more remote computers." While Klein’s system created mature "electronic reports and logs," it did not explicitly disclose transferring them to a remote computer. Hirschman taught an integrated radiopharmaceutical system where a control computer is optionally configurable to communicate with an imaging suite's information system (e.g., an HIS system) to update patient records with injection times, volumes, and activity levels. Similarly, Jackson disclosed a radiopharmaceutical system where a central control computer receives and stores data from local quality control units and computers to provide for more centralized storage of records.
    • Motivation to Combine: Petitioner contended that a person of ordinary skill in the art (POSITA) would have been motivated to modify Klein's system by incorporating the remote data transfer capabilities taught by Hirschman and Jackson for several reasons. The primary motivations included creating workflow efficiencies, eliminating data entry errors, and improving data security and redundancy by storing critical patient and safety data remotely. These were well-known benefits of networking medical devices. Hirschman and Jackson explicitly provided the motivation by describing the advantages of connecting infusion systems to larger hospital networks for centralized record-keeping and remote monitoring.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success in combining these teachings. Integrating known networking and data transfer functionalities into the computer-controlled system of Klein would have involved applying conventional techniques to achieve the predictable result of improved data management, a common objective in the medical device field.

4. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 21-23 of the ’468 patent as unpatentable.