Terumo BCT, Inc.

1. Case Identification

• Case #: IPR2025-01391
• Patent #: 10,758,652
• Filed: August 11, 2025
• Petitioner(s): Terumo BCT Inc.
• Patent Owner(s): Haemonetics Corp.
• Challenged Claims: 1-20

2. Patent Overview

• Title: System and Method for Collecting Plasma
• Brief Description: The ’652 patent discloses systems and methods for plasma apheresis. The purported invention is a real-time calculation of the volume of pure plasma collected by determining the volume of anticoagulant within the collected plasma component and subtracting it from the total collected fluid volume.

3. Grounds for Unpatentability

Ground 1: Claims 1, 5, 6, 8, 10, 11, 16, 17, and 19 are anticipated by or obvious over Takagi.

• Prior Art Relied Upon: Takagi (Japanese Patent Application Publication No. 2002-282352 A).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Takagi discloses all limitations of the challenged claims. Takagi teaches a blood component collection device that uses donor information, including weight and hematocrit, to determine a target plasma collection amount. During collection, Takagi's controller uses a weight sensor on the plasma collection bag to monitor the apparent volume of collected fluid (plasma plus anticoagulant). The controller then calculates the volume of anticoagulant in the bag and subtracts it to determine the "true current plasma collection amount" in real-time. Petitioner asserted this process directly maps to the ’652 patent's core method of calculating pure plasma volume based on a calculated anticoagulant volume as the plasma is being collected.
  • Motivation to Combine (for §103 grounds): To the extent any claim element is not explicitly disclosed, Petitioner argued it would have been obvious to use Takagi's known system for its intended purpose of accurately tracking collected plasma volume.
  • Expectation of Success (for §103 grounds): A person of ordinary skill in the art (POSITA) would have had a high expectation of success, as the argument relies on implementing the functions explicitly described in the Takagi reference.

Ground 2: Claims 1, 3, 5, 6, 8, 10-12, 14, 16-17, and 19 are anticipated by or obvious over Lavender.

• Prior Art Relied Upon: Lavender (Patent 4,898,675).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued Lavender's system for fractionating blood anticipates the claims. Lavender's microprocessor performs real-time calculations using donor hematocrit and a predefined anticoagulant ratio to determine both the total pure plasma filtered (TPF) and the total citrate/anticoagulant filtered (TCF). Petitioner contended that because TPF and TCF are directly dependent on the same predefined ratio and underlying measurements, a calculation of TPF is inherently based on the calculated TCF. This satisfies the claim requirement of calculating pure plasma volume based, at least in part, on a calculated anticoagulant volume. For dependent claims, Lavender was argued to disclose determining anticoagulant volume based on pump rotations and setting a target plasma volume based on donor weight.
  • Motivation to Combine (for §103 grounds): If not found to be inherent, Petitioner argued a POSITA would have found it obvious to recognize the direct mathematical interdependency between the calculated pure plasma and anticoagulant volumes in Lavender's system.
  • Expectation of Success (for §103 grounds): A POSITA would have readily understood how to use the relationships and algorithms disclosed in Lavender to achieve the claimed method, as it involves applying basic mathematical principles to the disclosed variables.

Ground 3: Claims 2, 9, 13, and 20 are obvious over Takagi in view of Min.

• Prior Art Relied Upon: Takagi (Japanese Patent Application Publication No. 2002-282352 A) and Min (Patent 8,075,468).

• Core Argument for this Ground:

  • Prior Art Mapping: Petitioner argued that Takagi provides the base system for collecting plasma as described in Ground 1. Min was cited for its teaching of using weigh sensors to track weight changes in an anticoagulant source container to determine the volume of anticoagulant introduced into the system. Min also discloses accounting for anticoagulant added during a priming step.
  • Motivation to Combine (for §103 grounds): A POSITA would combine Min's technique of monitoring the anticoagulant source weight with Takagi's system to provide a more direct and potentially more accurate measurement of the anticoagulant volume added to the system, thereby improving the accuracy of the final pure plasma calculation. This represents the application of a known technique (weight-based fluid monitoring from Min) to a similar system (Takagi) to improve its performance.
  • Expectation of Success (for §103 grounds): Success would be expected because both references operate in the same field of apheresis technology. Implementing a weight sensor on the anticoagulant source, as taught by Min, is a straightforward modification to the Takagi system, which already uses a weight sensor on the plasma collection container.

• Additional Grounds: Petitioner asserted additional obviousness challenges, including combining Lavender with Takagi, Headley, and Barrett to teach real-time hematocrit determination during a procedure (Ground 4 for claims 7 and 18), and combining Lavender with Takagi, Min, and Turgut to teach accounting for anticoagulant remaining in the separation device (Ground 5 for claims 4 and 15).

4. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-20 of Patent 10,758,652 as unpatentable.