PTAB

PGR2025-00077

Terumo BCT Inc v. Haemonetics Corp

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1. Case Identification

2. Patent Overview

  • Title: System for Collecting Plasma
  • Brief Description: The ’474 patent discloses systems and methods for collecting plasma during blood apheresis procedures. The purported invention involves determining the total volume of collected plasma by considering a donor's hematocrit level and the amount of anticoagulant added to the withdrawn whole blood.

3. Grounds for Unpatentability

Ground 1: Obviousness over Fletcher-Haynes and Bainbridge - Claims 1, 2, 6-7, 9-10, 12-13, 15-21, and 26 are obvious over Fletcher-Haynes in view of Bainbridge.

  • Prior Art Relied Upon: Fletcher-Haynes (Patent 7,072,769) and Bainbridge (Application # 2002/0033370).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Fletcher-Haynes, a blood collection system that maximizes component yield using donor parameters (e.g., weight, hematocrit), disclosed most limitations of the challenged claims. This included a controller that determines a target plasma volume based on donor data. Petitioner contended that Bainbridge, which also discloses an apheresis system, supplied the missing limitations, such as performing repeated draw and return cycles and dynamically monitoring hematocrit to establish a new target volume mid-procedure (limitation 1[j]).
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine these references because both relate to improving plasma apheresis. A POSITA would incorporate Bainbridge’s teaching of repeated draw and return cycles into Fletcher-Haynes to minimize the amount of blood withdrawn at once, thereby maximizing donor comfort. Further, a POSITA would be motivated to integrate Bainbridge’s real-time hematocrit monitoring to more accurately determine the amount of plasma collected, a goal consistent with the optimization taught by Fletcher-Haynes.
    • Expectation of Success: A POSITA would have a reasonable expectation of success because the references involve similar technologies and techniques. Fletcher-Haynes already performs draw and return phases, so repeating them as taught by Bainbridge would be a predictable modification. Similarly, incorporating dynamic hematocrit data into Fletcher-Haynes’ existing prediction model would involve straightforward software modifications.

Ground 2: Obviousness over Fletcher-Haynes, Bainbridge, and Lavender - Claims 3-4 and 22-25 are obvious over Fletcher-Haynes in view of Bainbridge and further in view of Lavender.

  • Prior Art Relied Upon: Fletcher-Haynes (Patent 7,072,769), Bainbridge (Application # 2002/0033370), and Lavender (Patent 4,898,675).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground built upon the combination of Fletcher-Haynes and Bainbridge by adding the teachings of Lavender. Petitioner argued that Lavender taught a system that performs real-time calculations during plasma collection, including repeatedly determining target volumes in a main loop approximately every two seconds. This addressed limitations in claims 3 and 4, which required redetermining the target volume prior to the start of each draw phase and repeating the draw/return phases at least three times.
    • Motivation to Combine: A POSITA modifying the Fletcher-Haynes/Bainbridge system would look to Lavender to implement procedure tracking and real-time calculations. Petitioner asserted that Fletcher-Haynes’ algorithms were essentially the same as Lavender’s, so a POSITA would have turned to Lavender to supply the requisite computer code for a repeatable calculation loop to track collection status.
    • Expectation of Success: Success would be expected because incorporating Lavender’s main loop into the Fletcher-Haynes system would be a known software modification yielding predictable results. The combination involved using similar equations to improve similar systems and methods.

Ground 3: Ineligibility Under §101 - All Claims are Patent Ineligible.

  • Prior Art Relied Upon: N/A
  • Core Argument for this Ground: Petitioner argued all claims were directed to patent-ineligible subject matter under 35 U.S.C. §101.
    • Alice Step One: The claims were directed to the abstract idea of performing a sequence of mathematical calculations based on donor and system parameters (e.g., using weight and hematocrit to determine a target plasma volume). Petitioner contended these calculations were equivalent to human mental work that a technician could perform with a pen and paper, merely automated on a generic computer.
    • Alice Step Two: The claims lacked an inventive concept sufficient to transform the abstract idea into a patent-eligible application. The claims simply recited automating known calculations on a general-purpose processor and using conventional, well-understood apheresis equipment (needles, pumps, separators). Petitioner asserted that replacing a technician with a generic computer to perform calculations did not supply an inventive concept, and any improvements in speed or efficiency were inherent to using a computer.

Ground 4: Lack of Written Description Under §112 - Claims 1-11 and 13-25 lack adequate written description.

  • Prior Art Relied Upon: N/A

  • Core Argument for this Ground: Petitioner argued that numerous claim limitations lacked adequate written description support in the ’474 patent’s specification. Key unsupported limitations included:

    • "Programming a controller": The specification allegedly disclosed a controller that may calculate certain volumes but never described it as being "programmed" to do so, nor how such programming would occur.
    • "Plasma product": The claims recited measuring or targeting a "plasma product" (plasma plus anticoagulant), but the specification’s focus was on collecting a target volume of "pure plasma" and taught away from collecting a plasma product.
    • "Draw and return cycles": The specification did not mention or describe the operation of draw and return "cycles," their repetition, or the control thereof, despite these features appearing in numerous claims.

  • Additional Grounds: Petitioner asserted additional obviousness challenges based on combinations including Kimura (Patent 10,195,319), Neyrinck ("Calculations in Apheresis," 2014), and Sakota (Patent 6,743,192). Petitioner also asserted a ground of anticipation/obviousness based on Fletcher-Haynes alone.

4. Relief Requested

  • Petitioner requests institution of Post-Grant Review and cancellation of claims 1-26 of the ’474 patent as unpatentable.