PTAB

PGR2025-00077

Terumo BCT Inc v. Haemonetics Corp

Key Events

Petition

petition

Title: System for Collecting Plasma
Brief Description: The ’474 patent discloses a system for plasma apheresis. The purported invention is a method and system that improve plasma collection by calculating a target volume of pure plasma based on donor-specific parameters (e.g., hematocrit) and accounting for the volume of anticoagulant added during the procedure, rather than relying on the total volume of anticoagulated plasma.

Prior Art Relied Upon: Fletcher-Haynes (Patent 7,072,769).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner argued that Fletcher-Haynes disclosed all elements of the challenged system claims. Specifically, Fletcher-Haynes taught a blood collection system with a controller programmed to receive donor parameters—including height, weight, sex, and hematocrit—via a touchscreen. This controller then uses prediction algorithms and equations to determine a target volume for plasma product based on the donor’s total blood volume, thereby anticipating the core limitations of the independent claims. For claim 7, Fletcher-Haynes was argued to disclose separately accounting for anticoagulant volume.
- Motivation to Combine (for §103 grounds): For any claim elements not explicitly disclosed, such as repeated draw-and-return phases, Petitioner contended it would have been obvious to a person of ordinary skill in the art (POSITA). A POSITA would repeat the disclosed draw and return phases to maximize donor comfort and accommodate separators with smaller volumes, which was a known and predictable modification.
- Expectation of Success: Success was expected as such a modification represented a simple repetition of a disclosed process to achieve a known benefit in the field of apheresis.

Prior Art Relied Upon: Fletcher-Haynes (Patent 7,072,769) and Bainbridge (Application # 2002/0033370).
Core Argument for this Ground:
- Prior Art Mapping: Petitioner asserted that Fletcher-Haynes provided the foundational apheresis system with a controller and predictive algorithms based on initial donor parameters. Bainbridge was argued to supply the missing elements, namely the explicit teaching of performing multiple, repeated draw-and-return cycles and using real-time, instantaneous hematocrit monitoring to establish a new target volume mid-procedure.
- Motivation to Combine: A POSITA would combine these references to enhance the system described in Fletcher-Haynes. Incorporating Bainbridge’s repeated cycles would improve donor comfort, a well-known goal in the art. Adding Bainbridge’s real-time hematocrit tracking to Fletcher-Haynes’s algorithm, which already relied on hematocrit as a key input, was a logical step to improve the accuracy of the plasma yield calculation during the procedure.
- Expectation of Success: A POSITA would have had a high expectation of success because both references are in the same field of plasma apheresis, and integrating a real-time data input (hematocrit) into an existing algorithm that already uses that same data type was a straightforward and predictable design choice.

Core Argument for this Ground:
- Petitioner argued the claims are directed to the patent-ineligible abstract idea of performing mathematical calculations. The core of the invention was contended to be the calculation of a target plasma volume using donor parameters and known formulas—a process that can be performed mentally or with pen and paper by a technician.
- The claims allegedly lack an inventive concept sufficient to transform the abstract idea into a patent-eligible application. Petitioner asserted that the claims merely automate these known calculations on a generic computer controller and apply them to a conventional apheresis process. The recitation of generic, conventional hardware (pumps, separators, needles, sensors) does not add an inventive concept, as these components are not improved and merely provide data for the abstract calculation.

Core Argument for this Ground:
- Petitioner argued that several key claim limitations are not supported by the disclosure, indicating the inventor was not in possession of the full scope of the claimed invention. Unsupported limitations allegedly include:
  - Programming a controller: The specification was said to disclose a controller that may perform calculations but did not describe how or when it is "programmed" to do so.
  - Draw and return cycles: The term "cycle" and the concept of repeating draw and return phases were asserted to be absent from the specification outside of the claims themselves.
  - Calculating new target volumes mid-donation: The specification allegedly only described calculating a single target volume before the procedure begins, not recalculating a new target during the procedure as required by certain claims.
  - Control system: The term "control system" as a distinct entity communicating with the controller was argued to appear only in the claims without antecedent basis or description in the specification.
Additional Grounds: Petitioner asserted additional obviousness challenges based on the Fletcher-Haynes and Bainbridge combination, further modified by Lavender (for real-time calculation loops), Kimura (for accounting for priming volume), Neyrinck (for using more accurate total blood volume formulas), and Sakota (for varying draw volume per cycle to enhance safety).

Petitioner requests institution of Post-Grant Review and cancellation of claims 1-26 of Patent 12,186,474 as unpatentable.