PTAB

IPR2026-00045

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 ’934 patent discloses systems and methods for plasma apheresis. The technology focuses on calculating a target plasma collection volume based on donor-specific parameters like weight, height, and hematocrit, and then controlling the apheresis process to collect that target volume while accounting for the amount of anticoagulant used.

3. Grounds for Unpatentability

Ground 1: Claims 1, 5, 6, 23-27, and 30 are obvious over Lavender in view of Neyrinck.

  • Prior Art Relied Upon: Lavender (Patent 4,898,675) and Neyrinck ("Calculations in Apheresis," Journal of Clinical Apheresis, 2015).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Lavender disclosed a complete, automated apheresis system that performs real-time calculations to control plasma collection. This system used donor parameters like weight and hematocrit to determine a target collection volume. However, Lavender's calculation for a donor's total plasma volume was a simplified estimate (5% of body weight). Petitioner asserted that Neyrinck taught more accurate and widely used methods for calculating a donor's total blood volume (TBV) and total plasma volume (TPV) based on the donor's weight, height, and hematocrit, including using Body Mass Index (BMI). The combination of Lavender's system with Neyrinck's more precise TPV calculation allegedly rendered the limitations of independent claims 1 and 23 obvious.
    • Motivation to Combine: A POSITA would combine Lavender and Neyrinck to improve the accuracy and donor-specific customization of Lavender's plasma collection calculations. Incorporating Neyrinck’s TPV calculation, which considers height in addition to weight and hematocrit, would yield a more individualized and safer collection target, improving both donor safety and product yield.
    • Expectation of Success: Petitioner contended a POSITA would have a reasonable expectation of success because both references relate to the same field of plasma apheresis and use similar donor-specific data to determine collection volumes. Implementing Neyrinck's well-known formulas into Lavender's computational framework would be a straightforward modification.

Ground 2: Claims 2-4, 8-13, 15-22, 28, and 29 are obvious over Lavender in view of Neyrinck and further in view of Fletcher-Haynes.

  • Prior Art Relied Upon: Lavender (Patent 4,898,675), Neyrinck (Journal of Clinical Apheresis, 2015), and Fletcher-Haynes (Patent 7,072,769).

  • Core Argument for this Ground:

    • Prior Art Mapping: This ground builds upon the combination of Lavender and Neyrinck by adding the teachings of Fletcher-Haynes. Petitioner argued that Fletcher-Haynes disclosed a blood collection system with prediction models that calculate target volumes for both pure plasma and the required anticoagulant, based on donor hematocrit. Specifically, Fletcher-Haynes provided equations (e.g., Equations 15, 17, and 22) for determining the fraction of anticoagulant in the collected plasma and for using that value to calculate target volumes. This teaching was asserted to supply the limitations in claims requiring the calculation of an anticoagulant volume based on hematocrit (e.g., claim 2) and defining the target collection volume as the sum of pure plasma and anticoagulant (e.g., claim 3).
    • Motivation to Combine: A POSITA would be motivated to incorporate Fletcher-Haynes's teachings into the Lavender/Neyrinck system to optimize plasma collection yield and better determine the target anticoagulant volume. Petitioner also noted that Fletcher-Haynes taught a more efficient centrifuge-based separation device, which a POSITA would have been motivated to substitute for Lavender's membrane-based system to reduce procedure time. Implementing Fletcher-Haynes's equations would provide a more accurate, hematocrit-based method for determining the target anticoagulant volume.
    • Expectation of Success: Petitioner argued success would be predictable because incorporating Fletcher-Haynes's algorithms was a known software modification. The mathematical principles were similar, and Petitioner asserted that a POSITA would have understood that the equations in Fletcher-Haynes were functionally equivalent to parameters used in Lavender, making the integration a routine design choice with predictable results.

  • Additional Grounds: Petitioner asserted that claim 7 is obvious over Lavender, Neyrinck, and Darashkevich (Application # 2011/0097344), and claim 14 is obvious over Lavender, Neyrinck, Fletcher-Haynes, and Darashkevich. These grounds relied on Darashkevich for its teaching of collecting a target percentage of plasma within a specific range (15-30%), arguing it would have been an obvious design choice to operate the primary combination within this disclosed range.

4. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-30 of the ’934 patent as unpatentable under 35 U.S.C. §103.