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 discloses a plasma apheresis system with a controller that determines the total volume of plasma collected from a donor. The system uses donor-specific parameters, such as hematocrit level and weight, along with the amount of anticoagulant added, to calculate and control the collection of a target plasma volume.

3. Grounds for Unpatentability

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

• Prior Art Relied Upon: Fletcher-Haynes (Patent 7,072,769).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Fletcher-Haynes, which discloses a blood collection system that maximizes component yield using prediction models, anticipates or renders obvious the challenged claims. Fletcher-Haynes allegedly taught a system with all key elements of independent claim 7: a venipuncture needle, a blood separator, a donor line controlled by a first pump, an anticoagulant line controlled by a second pump, a touchscreen for operator input, and a controller. The controller in Fletcher-Haynes was programmed to receive donor parameters like weight and hematocrit via the touchscreen to control draw and return phases.
  • Key Aspects: Petitioner contended that Fletcher-Haynes’s controller, which uses prediction algorithms based on donor weight and hematocrit to determine target yields, meets the limitations for calculating target volumes of plasma and/or raw plasma. For claim 8, Fletcher-Haynes’s system was argued to separately account for anticoagulant volume and plasma volume.

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

• 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 Bainbridge disclosed key features missing from or only implicitly taught by Fletcher-Haynes. Specifically, Bainbridge taught performing multiple, repeated draw and return cycles until a predetermined amount of plasma is collected. It also taught continuously monitoring a donor's hematocrit in real-time during the procedure to adjust flow rates and accurately achieve a target plasma volume.
  • Motivation to Combine: A POSITA would combine Fletcher-Haynes with Bainbridge to improve the system's performance and donor comfort. Incorporating repeated draw and return cycles, as taught by Bainbridge, would minimize the amount of blood withdrawn at any one time. Adding Bainbridge’s real-time hematocrit monitoring would allow the Fletcher-Haynes prediction algorithms to use more accurate, dynamic data, thereby improving the precision of the plasma collection process.
  • Expectation of Success: A POSITA would have a reasonable expectation of success because both references related to apheresis technology and employed similar techniques. Integrating Bainbridge’s iterative cycles and real-time monitoring into Fletcher-Haynes’s algorithm-based control system would involve routine software modifications with predictable results.

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

• Prior Art Relied Upon: Not applicable.
• Core Argument for this Ground:
  • Alice Step One (Abstract Idea): Petitioner argued all claims are directed to the abstract idea of performing mathematical calculations. The core of the alleged invention was using known donor parameters (weight, hematocrit) and system data to calculate a target plasma volume—a mental process that a technician could perform with pen and paper. The claims simply automated this abstract calculation on a generic computer.
  • Alice Step Two (Inventive Concept): Petitioner contended the claims lack an inventive concept sufficient to transform the abstract idea into a patent-eligible application. The claims recited only generic, conventional apheresis components (pumps, needles, separator, touchscreen) and a general-purpose controller. Automating a known human calculation on a standard computer, without any improvement to the computer's functionality itself, does not provide the required inventive concept to satisfy §101.

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

• Prior Art Relied Upon: Not applicable.

• Core Argument for this Ground:

  • Mapping to Specification: Petitioner argued that key limitations in the challenged claims lack adequate support in the ’916 patent’s specification. The petition highlighted several unsupported concepts:
    • "Programming a controller": The specification allegedly never described when, how, or by whom the controller is programmed.
    • "Plasma product": The specification was argued to focus almost exclusively on collecting "pure plasma" and teaches away from collecting a "plasma product" (a mix of pure plasma and anticoagulant).
    • "Draw and return cycles": The word "cycle" allegedly never appeared in the specification outside of the claims, and there was no disclosure of repeating cycles or controlling specific aspects of a cycle.
    • "Control system": The specification allegedly failed to describe the structure or function of the claimed "control system" that electronically provides donor parameters to the main controller.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including that claims 3-4 are obvious over Fletcher-Haynes, Bainbridge, and Lavender (Patent 4,898,675) for teaching a repeatable software loop for collection tracking. Further grounds argued claims 6 and 9 are obvious over the combination with Kimura (Patent 10,195,319) for teaching a final return step, and claim 13 is obvious over the combination with Sakota (Patent 6,743,192) for teaching a decreasing volume of blood draw in successive cycles.

4. Relief Requested

• Petitioner requests institution of Post-Grant Review and cancellation of claims 1-22 of the ’916 patent as unpatentable under 35 U.S.C. §§ 101, 102, 103, and 112.