PTAB

IPR2026-00046

Terumo BCT Inc v. Haemonetics Corp

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Petition
petition

1. Case Identification

2. Patent Overview

  • Title: System And Method For Collecting Plasma
  • Brief Description: The ’926 patent discloses systems and methods for collecting plasma via apheresis. The invention centers on a controller that calculates volumes of anticoagulant and pure plasma in real-time based on donor-specific parameters, such as weight and hematocrit, to determine a target collection volume and control the procedure.

3. Grounds for Unpatentability

Ground 1: Claims 1-4, 6-11, 13-18, 20-28, and 30 are obvious over Lavender in view of Fletcher-Haynes

  • Prior Art Relied Upon: Lavender (Patent 4,898,675) and Fletcher-Haynes (Patent 7,072,769).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Lavender taught a complete automated plasma apheresis system that already performed the core steps of the challenged claims. Lavender’s system used a microprocessor to calculate target volumes of pure plasma and anticoagulant based on donor data, including weight and hematocrit, and a predetermined anticoagulant-to-plasma ratio. However, Petitioner contended that Fletcher-Haynes provided more sophisticated prediction algorithms for optimizing apheresis procedures. Specifically, Fletcher-Haynes taught equations for calculating a target anticoagulant volume and a target pure plasma volume that explicitly incorporated a donor’s hematocrit and weight to improve accuracy. Petitioner asserted that implementing Fletcher-Haynes's more precise calculation methods into Lavender's established system framework rendered the claimed invention obvious. For example, independent claims 1 and 15 require calculating a volume of anticoagulant based on the donor's hematocrit and a target volume of pure plasma based on the donor's weight. Lavender disclosed calculating a target plasma volume based on weight, while Fletcher-Haynes explicitly disclosed equations for calculating a target anticoagulant volume based on hematocrit. The combination of these teachings, Petitioner argued, met all limitations of the independent claims.
    • Motivation to Combine: A POSITA would combine Lavender and Fletcher-Haynes to improve the accuracy of Lavender’s system. Incorporating Fletcher-Haynes's use of additional donor-specific parameters (like height) and its refined, hematocrit-based equations into Lavender’s system was presented as a predictable way to achieve a more accurate determination of the optimal plasma and anticoagulant volumes to collect. Both references are directed to the same field of plasma apheresis and seek to optimize the collection process, providing a strong motivation for combination.
    • Expectation of Success: Petitioner argued a POSITA would have had a high expectation of success. The combination involved applying Fletcher-Haynes's known mathematical algorithms to Lavender’s well-known apheresis system, which would constitute a routine software modification. Petitioner demonstrated that the underlying equations in both references were conceptually equivalent, ensuring the integration would yield predictable and successful results without changing the fundamental operation of Lavender's device.

Ground 2: Claims 5, 12, 19, and 29 are obvious over Lavender in view of Fletcher-Haynes and Min

  • Prior Art Relied Upon: Lavender (Patent 4,898,675), Fletcher-Haynes (Patent 7,072,769), and Min (Patent 8,075,468).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built upon the combination of Lavender and Fletcher-Haynes and added Min to address the specific limitations of claims 5, 12, 19, and 29. These dependent claims require that the calculated volume of anticoagulant include at least a portion of anticoagulant added during a "priming step." While the primary combination of Lavender and Fletcher-Haynes taught calculating target volumes for the main collection procedure, Petitioner asserted that Min explicitly taught the missing element. Min disclosed a blood processing system that included pre-collection cycles where a predetermined volume of anticoagulant was conveyed into the system's tubing and in-process container to prime the system before plasma collection began. Petitioner argued that adding this teaching from Min to the base combination directly satisfied the priming step limitation.
    • Motivation to Combine: A POSITA would be motivated to incorporate Min’s teachings into the Lavender/Fletcher-Haynes system for the same reason as the primary combination: to improve accuracy. By accounting for the volume of anticoagulant used during the priming step, the system could more precisely calculate the total amount of anticoagulant collected with the plasma. Failing to account for this priming volume would introduce a known source of error into the final volume calculations. Therefore, incorporating Min's technique was a logical and obvious step to enhance the precision of the overall system.
    • Expectation of Success: Success would have been reasonably expected because all three references address similar blood processing technologies and employ common components. Adding a priming step as taught by Min to the apheresis procedure of Lavender/Fletcher-Haynes was a straightforward and predictable modification. Petitioner also argued that a POSITA would have an expectation of success in modifying the system's algorithms to account for the additional anticoagulant volume from priming, as it was a simple additive calculation.

4. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-30 of Patent 10,980,926 as unpatentable under 35 U.S.C. §103.