PTAB

PGR2026-00009

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 ’873 patent relates to a plasma apheresis system and method for determining the volume of pure plasma collected from a donor. The invention purports to more accurately calculate this volume using a controller that considers the donor's hematocrit, a ratio of anticoagulant added to the withdrawn whole blood, and the total volume of the collected plasma component (plasma mixed with anticoagulant).

3. Grounds for Unpatentability

Ground 1: Claims 1-5, 7, 8, 10-17, and 19-23 are anticipated and/or obvious over Lavender.

  • Prior Art Relied Upon: Lavender (Patent 4,898,675).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Lavender discloses an automated system for fractionating blood that meets all challenged claim limitations. For the core limitation of independent claim 1—calculating a volume of pure plasma based on (i) collected plasma component volume, (ii) an anticoagulant ratio, and (iii) donor hematocrit—Petitioner asserted that Lavender’s method for calculating "total plasma filtered" (TPF) inherently uses these same inputs. Specifically, Lavender's TPF calculation depends on a "plasma dilution factor" (PDF), which Petitioner argued is a ratio of anticoagulant to plasma, and on the plasma flow rate, which Lavender calculates using the donor’s hematocrit.
    • Key Aspects: Petitioner contended that Lavender’s system also discloses the features of dependent claims, such as monitoring component volume and weight, setting target collection volumes based on donor weight, using a microprocessor as a controller, and returning other blood components to the donor after plasma collection.

Ground 2: Claims 1 and 24-30 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 if the Board were to find Lavender does not inherently disclose the specific calculation of claim 1, it would have been obvious to modify Lavender’s system with the explicit teachings of Fletcher-Haynes. Fletcher-Haynes discloses detailed prediction algorithms and specific equations for calculating a target pure plasma volume and anticoagulant fraction, expressly using a donor's hematocrit and an anticoagulant-to-blood ratio as inputs. A person of ordinary skill in the art (POSITA) could readily integrate Fletcher-Haynes's equations into the microprocessor-controlled system of Lavender.
    • Motivation to Combine: A POSITA would combine the references to more accurately track and optimize the amount of plasma collected. Fletcher-Haynes’s more sophisticated prediction models, which use additional donor parameters like height and weight alongside hematocrit, offered a known method to improve the accuracy and efficiency of existing apheresis systems like Lavender's.
    • Expectation of Success: Petitioner asserted a high expectation of success, as both patents operate in the same well-understood field of apheresis technology, apply substantially similar techniques to achieve similar results, and integrating a known calculation into an existing automated system would yield predictable improvements.

Ground 3: Claims 1-30 are ineligible under 35 U.S.C. §101.

  • Prior Art Relied Upon: N/A (legal ground based on Alice Corp. v. CLS Bank).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued the claims are directed to the patent-ineligible abstract idea of performing mathematical calculations. The core of the invention is a mathematical formula for determining pure plasma volume using known inputs (donor hematocrit, anticoagulant ratio, collected volume). Petitioner contended this is a mental process that a technician could perform with pen and paper. Under Alice Step One, the claims are directed to this abstract idea.
    • Motivation to Combine (N/A):
    • Expectation of Success (N/A):
    • Key Aspects: Under Alice Step Two, Petitioner argued the claims lack an inventive concept. The claims merely automate a known calculation using generic, conventional apheresis equipment (e.g., pumps, sensors, containers) and a general-purpose controller. This automation does not improve the functionality of the computer or the underlying apheresis process itself but simply uses a computer as a tool for its intended purpose of calculation, which is insufficient to confer patent eligibility.

  • Additional Grounds: Petitioner asserted additional obviousness challenges based on combinations including Min (Patent 8,075,468), Headley (Patent 6,296,602), Barrett (Patent 9,370,324), and Turgut (Application # 2017/0029762). Petitioner also raised a challenge that claims 10-12, 22, 23, and 25 lack adequate written description under §112.

4. Relief Requested

  • Petitioner requests institution of Post Grant Review and cancellation of claims 1-30 of the ’873 patent as unpatentable.