Terumo BCT, Inc. v. Haemonetics Corp.

1. Case Identification

• Case #: PGR2025-00078
• Patent #: 12,171,916
• Filed: September 5, 2025
• Petitioner(s): Terumo BCT Inc.
• Patent Owner(s): Haemonetics Corp.
• Challenged Claims: 1-22

2. Patent Overview

• Title: System and Method for Collecting Plasma
• Brief Description: The ’916 patent relates to a plasma apheresis system. The purported invention involves determining the total volume of collected pure plasma by accounting for a donor’s hematocrit level and the amount of anticoagulant added to withdrawn whole blood.

3. Grounds for Unpatentability

Ground 1: Anticipation/Obviousness over Fletcher-Haynes - Claims 7-8, 14, 16-21

• Prior Art Relied Upon: Fletcher-Haynes (Patent 7,072,769).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Fletcher-Haynes anticipates or renders obvious the challenged claims by disclosing a complete blood collection system with all claimed elements. This included a venipuncture needle, a blood separator, a donor line with a first pump, an anticoagulant line with a second pump, and a touchscreen interface. Critically, Fletcher-Haynes was argued to disclose a controller that receives donor parameters (weight, hematocrit) via the touchscreen to determine a target plasma volume, control the system’s operation including draw and return phases, and separately account for anticoagulant and pure plasma volumes using specific prediction algorithms and equations.
  • Motivation to Combine: For the obviousness assertion, Petitioner contended that if Fletcher-Haynes is found not to explicitly disclose repeated draw and return phases, a POSITA would be motivated to implement them to maximize donor comfort and manage the volume of extracorporeal blood, which was a well-known practice in single-needle apheresis systems.

Ground 2: Obviousness over Fletcher-Haynes and Bainbridge - Claims 1-2, 5, 7-8, 10-12, 14-22

• 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, while Bainbridge supplied the missing elements related to dynamic, mid-procedure adjustments. Specifically, Bainbridge taught continuously monitoring a donor's hematocrit during the collection process, as it is known to change. This real-time data was used to establish a new target plasma volume during the procedure. Bainbridge also explicitly disclosed performing multiple, repeated draw and return cycles until a predetermined target volume was harvested.
  • Motivation to Combine: A POSITA would combine these references to improve the accuracy and efficiency of the system in Fletcher-Haynes. Since donor hematocrit changes during a procedure, incorporating Bainbridge’s real-time monitoring would allow for more precise control over the collected plasma volume, a key goal of such systems. The combination was presented as the application of a known improvement (dynamic monitoring) to a similar, known system (Fletcher-Haynes).
  • Expectation of Success: Petitioner argued a POSITA would have a high expectation of success, as both references operate in the same technical field of plasma apheresis. The proposed modification would involve integrating known monitoring techniques and control logic, which were considered predictable software modifications for a skilled artisan.

Ground 3: Patent Ineligibility under §101 - Claims 1-22

• Core Argument for this Ground:
  • Abstract Idea: Petitioner argued all claims are directed to the patent-ineligible abstract idea of performing mathematical calculations. The core of the alleged invention was identified as the use of algorithms to calculate a target plasma volume based on known inputs like donor weight, hematocrit, and anticoagulant ratios. Petitioner asserted these calculations could be performed mentally or with a pen and paper.
  • No Inventive Concept: Petitioner contended the claims lack an inventive concept sufficient to transform the abstract idea into a patent-eligible application. The claims merely recited automating these known calculations using a generic controller and displaying them on a generic touchscreen. The use of conventional apheresis hardware (pumps, separators, needles) was argued to be mere data-gathering in service of the abstract calculation and did not improve the functionality of the computer or the apheresis equipment itself.

Ground 4: Lack of Written Description under §112 - Claims 1-4, 6-7, 10-21

• Core Argument for this Ground:

  • Petitioner argued that several key claim limitations lacked adequate written description support in the ’916 patent’s specification. The petition asserted that the patent owner improperly introduced new matter in the claims of this continuation patent.
  • Key unsupported limitations included:
    • "Programming a controller": The words "program" or "programmed" allegedly appeared only in the claims, with no corresponding description of how, when, or by whom the controller is programmed.
    • "Plasma product": The specification was argued to focus exclusively on collecting a target volume of "pure plasma" and teaches away from collecting a "plasma product" (plasma plus anticoagulant).
    • "Draw and return cycles": The word "cycle" was said to be absent from the specification, which did not describe performing the apheresis steps in distinct, repeated cycles as required by the claims.
    • "Control system": The claims’ requirement for interaction with a separate "control system" was alleged to be entirely unsupported, as the specification and figures did not disclose such a component.

• Additional Grounds: Petitioner asserted additional obviousness challenges based on combinations of Fletcher-Haynes and Bainbridge with Lavender, Kimura, and Sakota, relying on similar design modification theories to add further known features.

4. Relief Requested

• Petitioner requests institution of Post-Grant Review and cancellation of claims 1-22 of Patent 12,171,916 as unpatentable.