Terumo BCT Inc v. Haemonetics Corp

1. Case Identification

• Case #: IPR2025-01420
• Patent #: 10,792,416
• Filed: October 9, 2025
• Petitioner(s): Terumo BCT Inc.
• Patent Owner(s): Haemonetics Corp.
• Challenged Claims: 1-30

2. Patent Overview

• Title: System and Method for Collecting Plasma
• Brief Description: The ’416 patent discloses systems and methods for plasma apheresis. The technology focuses on determining a target volume of plasma to collect based on donor-specific parameters like weight and hematocrit, and then using real-time calculations that account for the volume of anticoagulant to accurately control the collection process until the target is met.

3. Grounds for Unpatentability

Ground I: Claims 1, 7, 9, 11, 14, and 15 are obvious over Lavender in view of Neyrinck

• Prior Art Relied Upon: Lavender (Patent 4,898,675) and Neyrinck ("Calculations in Apheresis," a 2015 journal article).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that Lavender, a system for continuously fractionating blood, discloses the core elements of independent claim 1. Lavender’s system determines donor weight and hematocrit, calculates a target plasma collection volume based on those parameters, withdraws whole blood, separates plasma, introduces anticoagulant, and uses a microprocessor to perform real-time calculations to determine the volume of pure plasma and anticoagulant in the collection container based on weight measurements. Petitioner argued Lavender’s calculation for total donor plasma volume was simplified (a percentage of donor weight). Neyrinck was cited for teaching more advanced and accurate methods for calculating a donor’s total plasma volume (TPV) based on total blood volume (TBV), which is derived from the donor’s height, weight, and hematocrit.
  • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine Neyrinck’s more accurate TPV calculation with Lavender's system to improve the accuracy and donor-specific customization of plasma collection volumes. This would enhance both donor safety and product yield by moving from a simple weight-based estimate to a more comprehensive calculation.
  • Expectation of Success: Petitioner argued success would be expected because both references operate in the well-known field of plasma apheresis and use similar donor parameters. Incorporating Neyrinck’s established formulas into Lavender’s existing computational framework was presented as a predictable and straightforward improvement.

Ground II: Claims 2-6, 17-22, 24, 26, 28, and 29 are obvious over Lavender and Neyrinck, further in view of Bainbridge

• Prior Art Relied Upon: Lavender (Patent 4,898,675), Neyrinck (a 2015 journal article), and Bainbridge (Application # 2002/0033370).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground builds on the combination of Lavender and Neyrinck to address claims related to returning fluid to the donor and managing intravascular deficits. Petitioner argued that Bainbridge teaches a centrifuge-based apheresis system that uses a single line for both drawing and returning blood components. Critically, Bainbridge discloses administering a replacement fluid, such as saline, during the return cycle to maintain donor hydration. The volume of this replacement fluid is based on a target "fluid balance percentage" to manage the donor’s intravascular deficit, with a 100% balance corresponding to a zero-milliliter deficit.
  • Motivation to Combine: A POSITA would be motivated to integrate Bainbridge's features into the Lavender/Neyrinck system for two primary reasons: efficiency and safety. First, a POSITA would replace Lavender's membrane separator with Bainbridge's centrifuge-based separator, a known design choice to reduce procedure time. Second, incorporating Bainbridge’s method for administering saline would ensure donor safety by preventing dehydration and hypovolemia, a known risk in apheresis procedures.
  • Expectation of Success: Success was deemed highly likely because all three references relate to apheresis technology. The modifications—substituting a known component type (centrifuge for a membrane) and adding a standard safety feature (saline reinfusion)—were argued to be predictable improvements with no technical barriers.

Ground III: Claim 8 is obvious over Lavender in view of Neyrinck and Darashkevich

• Prior Art Relied Upon: Lavender (Patent 4,898,675), Neyrinck (a 2015 journal article), and Darashkevich (Application # 2011/0097344).
• Core Argument for this Ground:
  • Prior Art Mapping: This ground targets the specific numerical range recited in dependent claim 8, which requires the target percentage of plasma collected to be "between 26.5 and 29.5 percent of the donor's plasma volume." Petitioner noted that the base combination of Lavender and Neyrinck teaches setting a target collection percentage (Lavender uses 18%). Darashkevich, which discloses methods for removing pathogenic autoantibodies via plasmapheresis, explicitly teaches removing "between about 15% to 30% of the patient's total circulating plasma."
  • Motivation to Combine: Petitioner argued that a POSITA, seeking to optimize the plasma collection volume in the Lavender/Neyrinck system, would naturally look to other art in the field, like Darashkevich, for guidance on established and effective collection ranges. Modifying Lavender’s 18% target to a value within the 15-30% range taught by Darashkevich would have been an obvious design choice.
  • Expectation of Success: Choosing a specific value from a prior art-disclosed range for an operating parameter was presented as a routine and predictable modification that would yield the expected result of collecting more plasma. The claimed range of 26.5-29.5% falls squarely within Darashkevich's disclosed range.
• Additional Grounds: Petitioner asserted additional obviousness challenges based on combinations including Min (Patent 8,075,468), Turgut (Application # 2017/0029762), Headley (Patent 6,296,602), and Barrett (Patent 9,370,324). These grounds relied on similar design modification theories to address limitations such as using weight sensors to monitor anticoagulant sources, determining anticoagulant volume remaining in the separation device, and using optical sensors for real-time hematocrit calculations.

4. Relief Requested

• Petitioner requests institution of an inter partes review and cancellation of claims 1-30 of Patent 10,792,416 as unpatentable under 35 U.S.C. §103.