Terumo BCT Inc v. Haemonetics Corp

1. Case Identification

• Case #: PGR2026-00006
• Patent #: 12,377,204
• Filed: October 21, 2025
• Petitioner(s): Terumo BCT Inc.
• Patent Owner(s): Haemonetics Corp.
• Challenged Claims: 1-30

2. Patent Overview

• Title: System for Collecting Plasma
• Brief Description: The ’204 patent discloses systems and methods for plasma apheresis. The invention is directed to a controller that calculates a target plasma collection volume based on donor-specific parameters, such as height, weight, and hematocrit, to determine the total volume of plasma that has been collected after being mixed with an anticoagulant.

3. Grounds for Unpatentability

Ground 1: Anticipation over Fletcher-Haynes - Claims 8, 11-15, 17-20, 23-24, and 27-29 are anticipated by Fletcher-Haynes under 35 U.S.C. §102.

• 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, teaches every element of the challenged claims. Specifically for representative claim 8, Fletcher-Haynes was alleged to disclose a complete apheresis system including a venous-access device, a blood component separation device, lines, and pumps. Critically, Petitioner asserted that Fletcher-Haynes’s controller runs a “prediction model” using algorithms that calculate a target plasma amount based on a donor’s hematocrit and total blood volume, where the total blood volume is itself calculated using the donor's height and weight.
  • Key Aspects: Petitioner contended that Fletcher-Haynes’s detailed equations for determining anticoagulant ratio (using hematocrit), total blood volume (using height and weight), and target pure plasma volume directly map onto the calculation steps required by the claims.

Ground 2: Obviousness over Fletcher-Haynes and Lavender - Claims 1, 3-7, 9, 21-22, 25, and 30 are obvious over Fletcher-Haynes in view of Lavender under 35 U.S.C. §103.

• Prior Art Relied Upon: Fletcher-Haynes (Patent 7,072,769) and Lavender (Patent 4,898,675).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Fletcher-Haynes taught the core system for calculating a target plasma volume, while Lavender supplied the motivation and teachings for a controller configured to stop the collection process once that target is reached. Lavender disclosed an automated system that monitors the collected plasma volume (e.g., by weight) and stops the pumps when a predetermined maximum volume, calculated based on donor weight, is achieved.
  • Motivation to Combine: A POSITA would combine these references because both relate to improving plasma apheresis and use similar donor-specific inputs. Petitioner asserted a POSITA would find it obvious to implement the collection-stopping feature from Lavender into the target-calculating system of Fletcher-Haynes. This combination would simply automate a known apheresis procedure: collecting a specific amount of plasma and then stopping.
  • Expectation of Success: Petitioner argued there would be a high expectation of success, as combining the systems would involve a routine software modification to integrate Lavender’s main loop logic, yielding the predictable result of a system that calculates a target and then stops upon reaching it.

Ground 3: Patent Ineligibility under §101 - All claims (1-30) are directed to patent-ineligible subject matter.

• Prior Art Relied Upon: Not applicable.
• Core Argument for this Ground:
  • Alice Step 1 (Abstract Idea): Petitioner argued that the claims were directed to the abstract idea of performing mathematical calculations. The core of the invention was identified as using donor parameters (height, weight, hematocrit) in a series of equations to determine a target plasma volume. Petitioner asserted these are fundamental calculations that a technician could perform mentally or with pen and paper, and the claims merely automate this process on a generic computer.
  • Alice Step 2 (Inventive Concept): Petitioner contended the claims lacked an inventive concept sufficient to transform the abstract idea into a patent-eligible application. The claims recited only generic, conventional apheresis equipment (pumps, lines, separation devices) that function as they normally would. This equipment, Petitioner argued, merely serves as a source for data gathering and does not represent a technical improvement or an unconventional arrangement. Automating known calculations on a general-purpose controller was not inventive.

Ground 4: Lack of Written Description and Indefiniteness under §112 - Claims 3, 6, 12, 14, 19-21, and 28-29 lack adequate written description, and claims 3, 8, 12, 20, 23, and 29 are indefinite.

• Prior Art Relied Upon: Not applicable.
• Core Argument for this Ground:
  • Written Description: Petitioner argued that claims requiring the calculation of an “optimized, safe target plasma donation volume” (e.g., claims 3, 12, 20, 29) lacked written description support. The specification allegedly provided no definition or guidance for what constitutes an “optimized” or “safe” volume, nor did it explain how to perform calculations to achieve such a result beyond using standard donor metrics.
  • Indefiniteness: For the same reason, Petitioner argued the terms “optimized” and “safe” rendered the claims indefinite under §112(b). Without an objective standard in the specification, a POSITA would not be able to determine the scope of the claims with reasonable certainty. Petitioner also argued that the phrase "the flow through the first line being controlled by a first pump" in claims 8 and 23 was indefinite due to a lack of antecedent basis and unclear scope of control.

4. Relief Requested

• Petitioner requested institution of post-grant review and cancellation of claims 1-30 of the ’204 patent as unpatentable.