Prior art

Based on a technical analysis of US patent 10,980,926 and its cited references, the most relevant prior art aims to automate and optimize the apheresis process by using donor-specific information. The core invention of the '926 patent is a method and system that calculates the volume of pure plasma by accounting for the volume of anticoagulant mixed into the final collected product, using the donor's hematocrit to make this calculation. The collection process is then stopped when a target volume of pure plasma is achieved, rather than a target volume of the total plasma-anticoagulant mixture.

The following cited patents are identified as the most relevant prior art.

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1. US Patent 5,437,598 A

• Full Citation: US Patent 5,437,598, "Automation of plasma sequestration," assigned to Cobe Laboratories, Inc.
• Publication Date: August 1, 1995 (Filed: January 21, 1994)
• Description: This patent describes an automated apheresis system that uses donor-specific data to calculate parameters for the collection procedure. A controller receives donor data, including height, weight, sex, and hematocrit, and uses this information to calculate the total volume of whole blood to be processed, the amount of anticoagulant to be used, and the amount of replacement fluid. The system then automatically collects a predetermined quantity of plasma.
• Potential Anticipation of US 10,980,926: This reference is highly relevant as it discloses several key elements of the '926 patent's independent claims (e.g., Claim 1, Claim 8).
  • Claim 1(a) determining a weight of a donor & 1(b) determining a hematocrit of the donor: Potentially anticipated. US'598 explicitly teaches entering donor data "such as the donor's height, weight, sex and hematocrit" into the system's controller (Column 4, lines 43-47).
  • Claim 1(d) calculating a target volume of pure plasma: Potentially anticipated. US'598 discloses that the controller uses the donor data to calculate parameters for the procedure and to sequester a "predetermined quantity of the plasma." This target quantity is necessarily based on donor weight to comply with safety and regulatory standards.
  • Claim 1(f)-(j) withdrawing, introducing anticoagulant, separating, collecting, continuing until target volume is reached: These general apheresis steps are all described in US'598.
  • Potential Gap for Anticipation: The inventive step of the '926 patent appears to be in Claims 1(c) and 1(e): calculating the specific volume of anticoagulant that will be present in the collected plasma based on hematocrit, and then determining a final target collection volume for the mixture based on a predefined pure plasma target. US'598 teaches calculating the total "amount of anticoagulant to be used" for the procedure but does not explicitly describe calculating the portion that ends up in the final product container and using that to adjust the endpoint for the mixture. It appears to set a target for the anticoagulated plasma product directly. Therefore, while extremely close, it may not anticipate these specific calculation steps under 35 U.S.C. § 102, but it would be a very strong reference for an obviousness challenge under § 103.

2. EP 0654277 A1

• Full Citation: European Patent Application EP 0654277 A1, "Blood component collection system with optimizer," assigned to Cobe Laboratories, Inc.
• Publication Date: May 24, 1995 (Filed: October 21, 1993)
• Description: Similar to US'598, this document describes an apheresis system that optimizes the collection procedure based on inputted donor data, including weight and hematocrit. The system's controller uses this information to determine the maximum amount of plasma that can be safely collected and to control the collection process efficiently.
• Potential Anticipation of US 10,980,926: This reference teaches the same core concepts as US'598 and has the same potential strengths and weaknesses as a prior art reference.
  • It clearly discloses using donor weight and hematocrit to determine a target plasma collection volume (potentially anticipating Claims 1(a), 1(b), and 1(d)).
  • It shares the same potential gap as US'598 regarding the specific calculation of the anticoagulant volume in the final product and the two-step determination of a "target collection volume" based on a "target pure plasma volume" (Claims 1(c) and 1(e)). This reference reinforces the state of the art at the time but likely does not directly anticipate the specific novel calculations claimed in the '926 patent.

3. US Patent 4,151,844 A

• Full Citation: US Patent 4,151,844, "Method and apparatus for separating whole blood into its components and for automatically collecting one component," assigned to Baxter Travenol Laboratories, Inc.
• Publication Date: May 1, 1979 (Filed: November 11, 1977)
• Description: This is an earlier, foundational patent for automated apheresis. It describes a system that automatically collects a predetermined quantity of a blood component (like plasma) and uses a weigh scale to monitor the collected amount. When the weight reaches a preset limit, the system automatically stops the collection.
• Potential Anticipation of US 10,980,926: This patent is less relevant than the Cobe references and does not anticipate the core claims of the '926 patent.
  • It discloses the general concept of collecting a target volume/weight of anticoagulated plasma.
  • However, it does not teach the use of donor-specific data like weight or hematocrit to calculate or adjust the target collection volume (lacking the elements of Claims 1(a), 1(b), 1(c), 1(d), and 1(e)). The "predetermined quantity" in this system appears to be a simple, fixed input, not a dynamically calculated value based on donor physiology.