PTAB

IPR2018-01449

Jubilant DraxImage Inc v. Bracco Diagnostics Inc

Log In

1. Case Identification

2. Patent Overview

  • Title: Computer-Controlled Safety Systems for Radiopharmaceuticals
  • Brief Description: The ’467 patent is directed to computer-controlled safety systems for radiopharmaceutical infusion generators. The system performs "breakthrough testing" of a radioactive eluate to determine if strontium contamination exceeds a safe limit, and if so, the system is configured to prevent the infusion to the patient.

3. Grounds for Unpatentability

Ground 1: Anticipation by Klein - Claims 1-4, 6-7, 9-10, 12-16, and 18-20 are anticipated by Klein under 35 U.S.C. §102.

  • Prior Art Relied Upon: Klein (a 2005 student thesis titled "Precise 82Rb Infusion System for Cardiac Perfusion Measurement Using 3D Positron Emission Tomography").
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Klein disclosed every limitation of the challenged independent claims. Klein described a complete, computer-controlled rubidium-82 infusion system housed in a shielded, mobile cart. The system included a computer carried by the cart, a radioisotope generator, and an electronically coupled dose calibrator. Critically, Klein’s system performed automated breakthrough testing by having the computer receive activity data, calculate breakthrough results based on strontium-82 and strontium-85 levels, and prevent patient infusions if results exceeded an allowable limit. Petitioner asserted that Klein’s protocol, which only "enabled" patient elutions after successful completion of daily prerequisite tests (including breakthrough tests), inherently taught preventing infusions when those tests failed.
    • Key Aspects: Petitioner contended that the Examiner allowed the claims during prosecution based on the specific limitation of preventing a patient infusion if a breakthrough test fails, a feature the Examiner believed was absent from the prior art. Petitioner argued that Klein expressly taught this function, and had the Examiner correctly identified this disclosure, the claims would have been rejected.

Ground 2: Obviousness over Klein in view of Tate - Claims 11 and 22 are obvious over Klein in view of Tate.

  • Prior Art Relied Upon: Klein and Tate (Application # 2008/0177126).
  • Core Argument for this Ground:
    • Prior Art Mapping: Claims 11 and 22 depend from independent claims 1 and 13, adding the limitations that a "shielding assembly is positioned inside a cabinet structure" and the "computer is carried by the cabinet structure." Petitioner asserted Klein taught a unitary system where the shielding assembly and the cart (cabinet) were one and the same. Tate, however, explicitly disclosed a radiopharmaceutical cart system with a distinct cabinet structure that housed a separate, internal shielding assembly.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine the teachings of Klein and Tate for several reasons. Both references address the same technical field of portable radiopharmaceutical infusion systems and share the common goal of minimizing radiation exposure. A POSITA would have viewed Klein's system as a functional prototype and looked to other designs like Tate for well-known and beneficial improvements, such as housing shielding components within an outer cabinet for a more integrated and user-friendly commercial product. This combination represented a simple substitution of a known design choice (Tate's cabinet/shielding configuration) into a known system (Klein's).
    • Expectation of Success: A POSITA would have had a reasonable expectation of success in implementing Tate's shielding configuration into Klein’s system, as it involved combining familiar elements to achieve a predictable result.

Ground 3: Obviousness over Klein in view of the Bracco Manual - Claims 8 and 21 are obvious over Klein in view of the Bracco Manual.

  • Prior Art Relied Upon: Klein and the Bracco Manual (a 2004 user guide for the commercial CardioGen-82® Infusion System).
  • Core Argument for this Ground:
    • Prior Art Mapping: Claims 8 and 21 add the limitation that the "given level of activity" for diverting eluate to a waste bottle is "approximately 1.0 millicurie per second (mCi/sec)." While Klein taught the general principle of diverting eluate until an activity threshold is met, it did not specify a value. The Bracco Manual, a guide for a widely used commercial system, explicitly disclosed an automatic infusion mode where eluate is routed to a waste bottle until its dose rate "exceeds the pre-selected dose-rate threshold of 1.0mCi/sec."
    • Motivation to Combine: A POSITA developing a system based on Klein's teachings would naturally consult established industry standards and documentation for commercial products, like the Bracco Manual, to determine an appropriate and safe operating parameter. The Bracco Manual provided the exact value for the activity threshold that was left unspecified by Klein. This combination was merely the application of a known value to a known process to achieve a predictable result.
    • Expectation of Success: Implementing a specific, known activity threshold from a commercial user manual into the functionally similar system of Klein was a straightforward design choice with a high expectation of success.

4. Arguments Regarding Discretionary Denial

  • Petitioner argued that the petition raised a new question of patentability that the U.S. Patent and Trademark Office had not previously considered. Although some references were cited during prosecution, Petitioner asserted that the key reference, Klein, was never substantively addressed for its disclosure of the dispositive limitation: preventing a patient infusion if a breakthrough test result exceeds an allowable limit. Petitioner contended this failure by the Examiner to recognize the full scope of Klein's teaching led to an erroneous allowance.

5. Relief Requested

  • Petitioner requested that the Board institute an inter partes review (IPR) and cancel claims 1-4, 6-16, and 18-22 of the ’467 patent as unpatentable.