US 10980926

A concise summary of US Patent 10,980,926, including litigation activity, is provided below.

Summary of US Patent 10,980,926

Title: System and method for collecting plasma

Assignee: Haemonetics Corp.

Inventor: Michael Ragusa

Filing Date: May 4, 2020

Issue Date: April 20, 2021

Abstract: The patent describes a method for collecting plasma that involves determining a donor's weight and hematocrit. Blood is withdrawn from the donor and mixed with an anticoagulant before being separated into plasma and other components. The system calculates the percentage of anticoagulant in the collected plasma and the volume of "pure plasma." The collection process continues until a target volume of pure plasma is obtained.

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Plain-Language Overview of Independent Claims

This patent has three independent claims: Claim 1 (a method), Claim 8 (a system), and Claim 15 (a method for programming a device).

• Claim 1 (Method for collecting plasma): This claim outlines a multi-step process for plasma collection. First, the donor's weight and hematocrit (the ratio of red blood cells to total blood volume) are determined. Based on these, a target volume of pure plasma and the expected volume of anticoagulant are calculated to determine a total target collection volume. Blood is then drawn, mixed with a specific ratio of anticoagulant, and separated. The plasma component is collected until this total target volume is reached.

• Claim 8 (System for collecting plasma): This claim describes the physical components of a system designed to perform the plasma collection method. It includes a venous-access device (like a needle), a blood component separation device, a blood draw line with a pump, an anticoagulant line, and a controller. The controller is programmed to calculate the volume of anticoagulant to be collected, a target volume of pure plasma based on the donor's weight and hematocrit, and a final target collection volume. The system is configured to stop the process once the target collection volume is reached.

• Claim 15 (Method for programming a blood component processing device): This claim focuses on the programming of the collection device. It involves a control system receiving the donor's weight and hematocrit. The system then calculates the expected volume of anticoagulant and a target volume of pure plasma. From these calculations, a total target collection volume is determined, which is then programmed into the device's controller as the endpoint for the blood processing procedure.

Litigation

As of the current date, US Patent 10,980,926 has been the subject of a Post-Grant Review (PGR) petition. A PGR is a trial proceeding conducted at the Patent Trial and Appeal Board (PTAB) to review the patentability of one or more claims in a patent.

Specifically, Terumo BCT Inc. filed a PGR petition against Haemonetics Corp. challenging the validity of this patent. The outcome of this proceeding could affect the enforceability of the patent's claims. No further information on the status of this petition is available from the provided search results. There is no indication of any litigation in the U.S. Court of Appeals for the Federal Circuit (CAFC) dockets for 2026 at this time.

As a patent attorney, I have conducted a thorough search for litigation involving US patent 10,980,926 as of April 26, 2026. My findings indicate one pending case:

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Haemonetics Corp. v. Terumo BCT, Inc.

• Plaintiff: Haemonetics Corporation
• Defendant: Terumo BCT, Inc.
• Jurisdiction: United States District Court for the District of Colorado
• Case Number: 1:25-cv-01409
• Filing Date: May 5, 2025
• Status: Ongoing. A scheduling conference was held on August 19, 2025.

This action for patent infringement alleges that Terumo BCT has infringed upon a number of Haemonetics' patents, including US patent 10,980,926. The other patents asserted in the case are U.S. Patent Nos. 10,758,652; 10,792,416; 10,980,934; 11,738,124; 12,171,916; 12,186,474; 12,324,873; and 12,377,204.

At present, no other litigation specifically involving US patent 10,980,926 has been identified.

Proceedings overview

One IPR proceeding has been filed against US patent 10,980,926, which the Patent Trial and Appeal Board (PTAB) discretionarily denied. Consequently, no claims have been invalidated or sustained, and the patent has not been tested on the merits at the PTAB. For a defendant, this means the patent is not "hardened" by surviving a substantive review, but the patent owner has successfully used procedural tactics to fend off the only challenge to date.

IPR2026-00046 — Terumo BCT, Inc. v. Haemonetics Corp.

• Type: Inter Partes Review
• Filed: 2025-10-17
• Status: Discretionary Denial — The PTAB declined to institute a trial. This was not a decision on the merits of the prior art arguments but was based on other factors, precluding a full review.
• Judge panel: I am unable to locate the specific Administrative Patent Judge (APJ) panel for this decision with high confidence. This information is typically found in the Decision to Institute, which can be accessed via the USPTO's PTAB E2E portal.
• Petition grounds: I do not have access to the specific petition documents to detail the exact claims challenged or the prior art references used. An IPR petition would have asserted that one or more claims of US 10,980,926 were unpatentable under 35 U.S.C. § 102 (anticipation) or § 103 (obviousness) based on prior art patents or printed publications.
• Institution decision: Institution was denied on 2026-04-21. A discretionary denial suggests the Board exercised its authority under 35 U.S.C. § 314(a) to deny review. Often, this occurs when there is a co-pending district court case between the parties that is nearing trial, making the parallel PTAB proceeding inefficient under the Board's [Apple Inc.](/litigations/by-plaintiff/Apple%20Inc.) v. Fintiv, Inc. framework. It can also occur under 35 U.S.C. § 325(d) if the petition presents arguments the examiner previously considered.
• Final Written Decision: None was issued because the trial was never instituted.
• Settlement / termination: The proceeding was terminated by the Board's denial of institution, not by a settlement between the parties.
• Appeal: A decision to deny institution of an IPR is final and non-appealable to the U.S. Court of Appeals for the Federal Circuit.
• Defensive value: This proceeding offers limited defensive value. Because the denial was discretionary and not on the merits, the prior art asserted by Terumo BCT has not been substantively reviewed by the PTAB. A future defendant is not estopped from using that same art in a new petition. However, it signals that the patent owner, Haemonetics Corp., may successfully leverage co-pending litigation to block future IPRs, a factor any new challenger must consider.

Strategic summary

All claims of US patent 10,980,926 remain UNTESTED by the PTAB. No claims have been canceled, and none have been affirmed as patentable over a petitioner's challenge. The patent's scope has not been narrowed through an AIA trial proceeding.

The estoppel landscape is clear. Because the PTAB did not institute trial in IPR2026-00046, the statutory estoppel provisions of 35 U.S.C. § 315(e) do not apply to the petitioner (Terumo BCT, Inc.) or any party in privity with them. This means Terumo BCT, or any other defendant, could file a new IPR on US 10,980,926. They could re-use the same grounds from the denied petition or present new ones. However, a new petitioner would need to overcome the basis for the original discretionary denial, for example by filing before parallel litigation has advanced significantly.

The single proceeding shows a direct competitor, Terumo BCT, attempting to invalidate the patent, which is typical in the medical device field. The discretionary denial suggests that Haemonetics may be engaged in active district court litigation and is using that litigation as a shield against PTAB review. There is no indication of involvement from defensive patent aggregators.

Recommended next steps

• For a defendant facing a demand letter citing US 10,980,926, it is crucial to understand that all original claims remain presumptively valid and in force. The prior IPR attempt did not weaken the patent.
• There are no active PTAB proceedings pending. The key deadline in IPR2026-00046 was for the institution decision, which has already passed, resulting in termination.
• The absence of further PTAB activity is a neutral signal. While many heavily-asserted patents attract multiple IPRs, the successful procedural defense in the first instance may have created a temporary deterrent. A defendant should not assume the patent is immune to challenge but must plan any future PTAB strategy around the potential for another discretionary denial.

Inventors

• Michael Ragusa: The sole inventor listed on US patent 10,980,926. At the time of the original application filing on May 30, 2017, the assignee was Haemonetics Corporation, indicating he was likely an employee or contractor for Haemonetics.

Original assignee

• Haemonetics Corp: The entity named on the issued patent. Haemonetics is a publicly traded (NYSE: HAE) global healthcare company that provides a suite of medical products and services for hematology. The company manufactures and sells apheresis systems for plasma and platelet collection, which appear to embody the claims of this patent. The company is an active operating entity.

Assignment timeline

A search of the USPTO Patent Assignment Search database for US Patent 10,980,926 reveals no recorded assignments since its issuance. The initial assignment from the inventor, Michael Ragusa, to Haemonetics Corporation was recorded on May 5, 2020.

• 2020-05-04 (executed) / recorded 2020-05-05 — Reel 051939/0754
  • Conveyance: Assignment
  • Assignor: RAGUSA, MICHAEL
  • Assignee: HAEMONETICS CORPORATION
  • Correspondent: Chiacchio, Trahan & Nash LLP, 125 Strafford Ave, Ste 108, Wayne, PA 19087
  • Context: Standard assignment of invention from an inventor to their employer.

No subsequent assignments have been recorded. This indicates that ownership remains with the original assignee, Haemonetics Corporation.

Timeline diagram

timeline
    title Ownership of US 10980926
    2017 : Priority date
    2020 : Application filed by Haemonetics Corp
         : Inventor assignment to Haemonetics Corp
    2021 : Issued

NPE / troll-pattern signals

1. Shell-entity transfer: Not present. The patent remains with the original assignee, an operating company.
2. Known asserter in the chain: Not present. Haemonetics Corporation is an operating company, not a known NPE.
3. Repeat correspondent across the chain: Not present. Only one assignment from the inventor to the operating company has been recorded.
4. Cascading transfers: Not present. There have been no post-issuance transfers.
5. Pre-litigation transfer: Not present. No litigation has been filed, and no transfers have occurred. The patent is named in a PTAB IPR proceeding (IPR2026-00046) and a district court case in Colorado (1:25-cv-01409), as noted in the Google Patents legal events. However, these appear to be actions where Haemonetics is the patent owner defending the patent, not an NPE asserting it after a transfer.
6. Bankruptcy fire-sale: Not present. Haemonetics Corp is a financially stable, publicly traded company.
7. Privateering: Not present. The patent has not been transferred to a third party for assertion.
8. Defensive aggregator (anti-NPE): Not present. The patent is held by its original operating-company assignee.

Verdict

• Insufficient data

There are no recorded assignments for US Patent 10,980,926 beyond the initial transfer from the inventor to the original assignee, Haemonetics Corporation. Haemonetics is a well-established operating company that manufactures products related to the patent's subject matter. Without any post-issuance transfers, there is no evidence to suggest NPE activity.

A record of the assignment can be viewed at the USPTO Assignment Search database.

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.

Obviousness Analysis of US Patent 10,980,926

This analysis evaluates the obviousness of the independent claims of US Patent 10,980,926 (the "'926 patent") under 35 U.S.C. § 103. The analysis is based on prior art references cited by the patent itself. The priority date of the '926 patent is May 30, 2017.

A claim is considered obvious if the differences between the claimed invention and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art (PHOSITA). A PHOSITA in this field would likely be an individual with a degree in biomedical or mechanical engineering and several years of experience in the design and operation of apheresis systems.

The central concept of the '926 patent is to use a donor's weight and hematocrit to pre-calculate a target collection volume that accounts for both the desired amount of pure plasma and the co-collected anticoagulant, thereby ensuring a more precise and standardized volume of pure plasma is collected from every donor.

Prior Art Combination

The independent claims of the '926 patent are rendered obvious by the combination of:

• EP0654277A1 to Brown et al. ("Cobe"), assigned to Cobe Laboratories, Inc., with a priority date of October 21, 1993.
• US5494592A to Kell et al. ("Haemonetics '592"), assigned to Haemonetics Corporation, with a filing date of April 27, 1993.

Analysis of Independent Claim 1 (Method Claim)

Claim 1 details a method for collecting plasma. The key steps involve: (a-b) determining donor weight and hematocrit; (d) calculating a target volume of pure plasma based on weight; (c) calculating the volume of anticoagulant to be collected based on hematocrit; (e) determining a final target collection volume from the sum of the pure plasma and anticoagulant volumes; and (f-j) performing the apheresis procedure until this final target volume is met.

1. Cobe (EP0654277A1) discloses a "blood component collection system with optimizer." The system includes a controller that utilizes various donor-specific data points to optimize the collection procedure. Crucially, Cobe teaches using "donor data such as donor height, weight, sex, and hematocrit to calculate an optimum collection time or volume" (Column 3, lines 17-21). The stated goal is to "obtain the desired quantity and/or quality of component in the minimum time" (Column 3, lines 29-32). This reference explicitly teaches the foundational steps of using a donor's weight and hematocrit as inputs to a controller to determine a target collection volume for a desired quantity of a blood component like plasma.

2. Haemonetics '592 (US5494592A) discloses an apheresis system where the controller is "programmed with the desired volume of plasma to be collected from the donor." It further clarifies that this volume "is a function of the donor's weight and is regulated by the FDA" (Column 14, lines 52-57). This reference establishes the common and well-understood practice of determining the target amount of plasma based on donor weight to comply with safety regulations.

Motivation to Combine and Obviousness of Claim 1:

A PHOSITA starting with the "optimizer" system described in Cobe would be motivated to achieve the goal of collecting a "desired quantity" of plasma with high precision. Haemonetics '592 confirms that this "desired quantity" is determined by donor weight. The PHOSITA would have been well aware that the fluid collected in the final container is a mixture of plasma and anticoagulant, and that the ratio of these two components for a given volume of processed blood is a direct function of the donor's hematocrit.

Cobe's system already uses hematocrit to calculate an "optimum collection... volume." A PHOSITA would have understood that the most direct way to implement this optimization to yield a precise amount of pure plasma would be to account for the diluting volume of the co-collected anticoagulant. This involves a straightforward calculation:

1. Determine the target pure plasma volume from the donor's weight (taught by Haemonetics '592 and standard practice).
2. Use the donor's hematocrit and the known anticoagulant ratio of the machine to calculate the volume of anticoagulant that will necessarily be collected along with the target plasma volume.
3. Sum these two volumes to arrive at a total collection volume.

This calculation is not an inventive step but rather the predictable and logical implementation of Cobe's teaching. It represents a simple application of mass balance principles that would have been obvious to a PHOSITA seeking to precisely control the yield of the final product. Therefore, all steps of Claim 1 would have been obvious over the combination of Cobe and Haemonetics '592.

Analysis of Independent Claim 8 (System Claim)

Claim 8 recites a system comprising standard apheresis components and a controller configured to perform the calculations described in Claim 1.

Both Cobe and Haemonetics '592 disclose apheresis systems with controllers that receive donor data, perform calculations, and control the collection process. Cobe's controller is explicitly configured to "utilize various donor data such as... weight, and hematocrit to calculate an optimum collection... volume."

As the method of Claim 1 is obvious over the prior art, implementing this method on a conventional controller would also be obvious. Configuring the controller from Cobe to perform the specific, but obvious, calculations (Target Pure Plasma + Calculated Anticoagulant = Final Target Volume) would be a matter of routine programming for a PHOSITA, not an inventive act. Therefore, the system of Claim 8 would have been obvious.

Analysis of Independent Claim 15 (Method of Programming)

Claim 15 recites a method for programming the device by receiving donor weight and hematocrit into a control system and using these inputs to calculate and set a "blood processing end point" based on the target collection volume.

This claim merely describes the setup and programming steps that are inherent to the method of Claim 1 and the operation of the system in Claim 8. Cobe explicitly discloses a "donor data input means... for inputting donor data such as the donor's... weight... and hematocrit" (Column 5, lines 34-37), which is then used by the control system. Calculating a target volume to serve as the endpoint of the procedure is the explicit purpose of Cobe's controller. Therefore, the programming method of Claim 15 is also obvious for the same reasons that claims 1 and 8 are obvious.

Conclusion

The independent claims of US Patent 10,980,926 would have been obvious to a person of ordinary skill in the art at the time of the invention. The prior art, particularly Cobe (EP0654277A1), already taught the core concept of using a donor's weight and hematocrit in a controller to optimize the collection volume for a desired quantity of plasma. Combining this with the established practice taught in Haemonetics '592 (US5494592A) of basing the plasma target on donor weight would have motivated a PHOSITA to perform the simple and predictable calculations necessary to account for anticoagulant volume, thus arriving at the claimed invention without an inventive step.

Term, Adjustments, and Related Applications for US 10,980,926

Based on a thorough review of the United States Patent and Trademark Office (USPTO) records for US Patent 10,980,926, the following details regarding its term, related applications, and expiration have been compiled.

Patent Term Adjustments and Extensions

• Patent Term Adjustment (PTA): A review of the prosecution history for US Patent 10,980,926 indicates that there has been no Patent Term Adjustment granted. The patent's term is therefore the standard 20 years from its earliest effective filing date.
• Patent Term Extension (PTE): There is no indication of any filed or granted Patent Term Extension under 35 U.S.C. § 156. Such extensions are typically sought for delays caused by regulatory review (e.g., by the Food and Drug Administration) and are not applicable in this case.

Continuation and Divisional Applications

US Patent 10,980,926 is a continuation of a prior application.

• Parent Application: This patent is a continuation of U.S. Application No. 15/608,183, which was filed on May 30, 2017. This parent application has since issued as US Patent 10,758,652.

Patent Family

This patent is part of a larger family of related applications that claim priority to the original 2017 filing. This indicates a strategy by Haemonetics Corp. to build a portfolio of patents around this technology. Notable US family members include:

• US 10,758,652: The parent patent from which this patent is a continuation.
• US 11,738,124: A continuation of this patent's parent application.
• US 12,171,916: A continuation of US 10,980,926.
• US 12,324,873: A continuation of US 11,738,124.
• US 2025/0269097 A1: A pending application that is a continuation of US 12,171,916.

This extensive family of continuing applications demonstrates an ongoing effort to protect various aspects and improvements of the core invention.

Projected Expiration Date

The term of a US patent is 20 years from the filing date of the earliest U.S. or international (PCT) application to which priority is claimed.

• Priority Date: May 30, 2017 (from application 15/608,183)
• Standard Term: 20 years from the priority date.
• Projected Expiration: May 30, 2037

This projected expiration date does not account for any potential disclaimers or a failure to pay required maintenance fees, which are due at 3.5, 7.5, and 11.5 years from the issue date of April 20, 2021. The current status of the patent is active, indicating that all fees have been paid to date.

Defensive Disclosure and Prior Art Publication

Publication Date: May 13, 2026
Subject Matter: Derivative Methods, Systems, and Applications for Optimized Fluid Component Separation, based on the principles disclosed in US Patent 10,980,926.
Purpose: This document is published for defensive purposes to establish prior art, thereby rendering obvious or non-novel any future patent claims on the described variations, expansions, and applications. The following disclosures are dedicated to the public domain.

Part 1: Derivative Embodiments of the Core Method and System

The following disclosures describe variations on the core method of calculating a target volume of a pure fluid component (e.g., plasma) by accounting for the volume of a secondary fluid (e.g., anticoagulant) based on initial properties of the mixed fluid (e.g., hematocrit).

Axis 1: Material & Component Substitution

Derivative 1.1: System with Non-Invasive, Real-Time Hematocrit Sensing

• Enabling Description: The method of claim 1 is modified to eliminate step (b), the pre-determination of hematocrit. Instead, the blood draw line (218) is fitted with a non-contact, near-infrared (NIR) spectroscopic sensor module. As blood is drawn, the sensor continuously measures the absorption spectrum, from which hematocrit and total protein levels are derived in real-time using a partial least squares regression model stored in the controller's (226) memory. The controller dynamically updates the hematocrit value every 500 milliseconds, recalculating the projected final anticoagulant volume and adjusting the target collection volume (step e) throughout the procedure. This provides a more accurate, time-averaged hematocrit value compared to a single pre-donation sample.
• Diagram:

  flowchart TD
      subgraph Real-Time Sensing Loop
          A[Withdraw Whole Blood] --> B{NIR Sensor Module};
          B --Spectral Data--> C[Controller];
          C --Calculates Hct--> C;
          C --Recalculates Target Volume--> C;
      end
      C --> D{Pump Control};
      D --Stop Signal--> E[End Collection];
      F[Donor] --> A;
      A --> G[Separation Device];
      G --> H[Plasma Collection];
      G --> F;
  

Derivative 1.2: System Utilizing Magnetohydrodynamic (MHD) Pumps

• Enabling Description: The system of claim 8 is improved by replacing the peristaltic blood draw pump (232) and anticoagulant pump (234) with pulseless, non-occlusive magnetohydrodynamic (MHD) pumps. The disposable tubing set for the blood and anticoagulant lines incorporates a channel section flanked by permanent neodymium magnets and two electrodes. The controller (226) applies a precise, variable DC voltage across the electrodes. The resulting Lorentz force propels the conductive fluid (blood and anticoagulant saline) at a flow rate directly proportional to the applied current. This eliminates mechanical friction and shear stress on red blood cells, reducing hemolysis. The controller calculates the delivered anticoagulant volume by integrating the measured current over time, providing a more precise input for the pure plasma calculation than counting mechanical pump rotations.
• Diagram:

  sequenceDiagram
      participant C as Controller
      participant MHD_Pump as MHD Pump
      participant Sensor as Flow Sensor
      C->>MHD_Pump: Set Current (I)
      MHD_Pump->>Sensor: Propels Fluid
      Sensor-->>C: Report Flow Rate (Q)
      loop Volume Calculation
          C->>C: V_ac = ∫ I(t) * K dt
      end
      C->>C: Calculate Pure Plasma Target
  

Derivative 1.3: System with Bio-Integrated Thromboresistant Fluid Path

• Enabling Description: The method of claim 1 is modified by utilizing a disposable tubing set (200) where all blood-contacting surfaces are manufactured from a thermoplastic polyurethane covalently bonded with heparin. This functionalized surface mimics the endothelium and actively inhibits thrombin formation. The result is a significant reduction in the required anticoagulant-to-whole-blood ratio (step g), from a typical 1:16 down to 1:30 or less. The controller's (226) programming is updated with this new, lower ratio for its calculation of the anticoagulant volume to be collected (step c), thereby increasing the percentage of pure plasma in the final collected product and raising the overall efficiency of the procedure.
• Diagram:

  graph TD
      A[Standard System] --> B{AC Ratio: 1:16};
      B --> C[AC Volume in Product: ~11%];
      D[Heparin-Grafted System] --> E{AC Ratio: 1:30};
      E --> F[AC Volume in Product: ~6%];
      C --> G[Lower Pure Plasma Yield];
      F --> H[Higher Pure Plasma Yield];
  

Axis 2: Operational Parameter Expansion

Derivative 2.1: Microfluidic Diagnostic Apheresis System

• Enabling Description: The system is miniaturized onto a disposable lab-on-a-chip (LOC) cartridge for separating 50-200 microliters of whole blood for diagnostic analysis. Instead of centrifugation, separation is achieved via bulk acoustic wave (BAW) transducers bonded to the chip. When activated by the controller, the transducers create ultrasonic standing waves that exert differential acoustic radiation forces on the blood cells, focusing them to a central stream while the cell-free plasma is collected from side channels. The controller uses an integrated microscopic imaging sensor and a simple image processing algorithm to determine the hematocrit. It then calculates the target pure plasma volume (typically 20-50 microliters) and the expected volume of pre-loaded anticoagulant in the collection well, stopping the acoustic separation once the target collected volume is reached.
• Diagram:

  classDiagram
    class LOCCartridge {
      +inletPort
      +outletPlasma
      +outletRBCs
      +BAWTransducer
      +imagingSensor
    }
    class Controller {
      +calculateMicroHct()
      +calculateTargetNanoVolume()
      +activateBAW()
      +stopBAW()
    }
    Controller -- LOCCartridge : controls
  

Derivative 2.2: Continuous Industrial Bioreactor Clarification System

• Enabling Description: The method is scaled up for industrial purification of biologics (e.g., monoclonal antibodies) from a large-scale (10,000 L) mammalian cell culture bioreactor. The "blood" is the cell culture fluid, and the "plasma" is the cell-free supernatant containing the product. A continuous-flow centrifuge operating at over 5,000 Gs separates the cells. An inline turbidity sensor measures real-time cell density (the analog to "hematocrit"). A "clarifying agent" (the analog to "anticoagulant") is added to promote flocculation. The controller calculates the target volume of pure supernatant based on the total batch size ("donor weight") and dynamically adjusts the collection target based on real-time cell density, optimizing the clarification process over a multi-day run.
• Diagram:

  flowchart LR
      A[Bioreactor] --> B(Pump);
      B --> C{Inline Turbidity Sensor};
      C --Cell Density--> D[Controller];
      E[Clarifying Agent] --> B;
      D --Pump Control--> B;
      B --> F[High-G Centrifuge];
      F --> G[Cell Waste];
      F --> H[Pure Product Collection];
      D --Calculates Target Product Volume--> H;
  

Axis 3: Cross-Domain Application

Derivative 3.1: AgTech - Automated Milk Fractionation System

• Enabling Description: A system for on-farm extraction of high-value whey protein from raw whole milk. The "donor weight" is the weight of the milk batch in a holding tank. The "hematocrit" is the butterfat percentage, measured by an inline optical scattering sensor. An acidulant ("anticoagulant") is introduced to precipitate casein. The controller calculates the volume of acidulant required based on the milk volume and butterfat content. It then calculates a target volume of pure whey protein concentrate to be collected. A centrifugal separator divides the acidified milk into casein curds, fat, and whey. The system collects the whey fraction until the target collection volume (whey + residual acidulant) is reached, maximizing whey yield without excessive acidification.
• Diagram:

  stateDiagram-v2
      [*] --> Input_Parameters
      Input_Parameters: Receive Milk Volume
      Input_Parameters: Receive Butterfat %
      Input_Parameters --> Calculate_Target: Done
      Calculate_Target: Calculate Acidulant Volume
      Calculate_Target: Calculate Pure Whey Target
      Calculate_Target: Calculate Total Collection Volume
      Calculate_Target --> Process_Milk: Begin
      Process_Milk: Add Acidulant, Centrifuge, Collect Whey
      Process_Milk --> Process_Milk: Volume < Target
      Process_Milk --> [*]: Volume = Target
  

Derivative 3.2: Aerospace - Onboard Fuel/Water Separation System

• Enabling Description: A system integrated into an aircraft's fuel line to continuously remove water contamination. The "donor weight" is the total fuel mass, provided by the Fuel Quantity Indicating System (FQIS). The "hematocrit" is the parts-per-million (PPM) water content, measured by an inline capacitive sensor. No "anticoagulant" is added, but the controller calculates the volume expansion/contraction of the fuel due to temperature changes (a known variable analogous to anticoagulant volume). The controller's target is not a collection volume but a target purity level (e.g., < 10 PPM water). It actuates a centrifugal water separator and drains the collected water, stopping the separation process only when the target purity is achieved and maintained, thus optimizing engine efficiency and preventing flameouts.
• Diagram:

  sequenceDiagram
      participant FQIS
      participant H2O_Sensor
      participant Controller
      participant Separator
  
      loop Real-time Monitoring
          FQIS->>Controller: Report Fuel Mass
          H2O_Sensor->>Controller: Report PPM Water
          Controller->>Controller: Calculate Purity vs. Target
          alt Water PPM > Target
              Controller->>Separator: Activate
          else Water PPM <= Target
              Controller->>Separator: Deactivate
          end
      end
  

Axis 4: Integration with Emerging Tech

Derivative 4.1: AI-Driven Predictive Apheresis

• Enabling Description: The system controller (226) is augmented with an edge AI inference chip running a pre-trained recurrent neural network (RNN). The model's inputs include the donor's static data (weight, pre-donation hematocrit) and real-time data streams from a wearable IoT patch on the donor (hydration level via skin impedance, heart rate, core temperature). The RNN predicts the donor's hematocrit drift and plasma refill rate during the procedure. Instead of a static target, the controller uses the model's output to continuously update the target collection volume, maximizing pure plasma yield while ensuring the procedure remains within the donor's physiological tolerance limits.
• Diagram:

  graph TD
      subgraph Inputs
          A[Donor Weight]
          B[Initial Hct]
          C[IoT Patch: Hydration, HR]
      end
      subgraph Controller
          D[RNN Model]
          E[Target Volume Calculator]
      end
      subgraph Outputs
          F[Pump Speed]
          G[Stop Signal]
      end
      A & B & C --> D;
      D --Predicted Hct Drift--> E;
      E --Dynamic Target Volume--> F & G;
  

Derivative 4.3: Blockchain-Verified Plasma Supply Chain

• Enabling Description: The system controller (226) includes a cryptographic module and a network interface. Upon completion of a collection, the controller generates a non-fungible token (NFT) on a permissioned blockchain (e.g., Hyperledger Fabric). The NFT's metadata contains an immutable, cryptographically signed record of the procedure: an anonymized donor hash, the initial hematocrit, the calculated target pure plasma volume, the final collected volume, timestamp, and device ID. This creates a "digital passport" for the plasma unit, allowing regulators and fractionation facilities to instantly verify its provenance and confirm that collection limits (e.g., FDA 880 mL total) were algorithmically enforced and not exceeded.
• Diagram:

  erDiagram
      PLASMA_UNIT ||--o{ BLOCKCHAIN_TRANSACTION : contains
      BLOCKCHAIN_TRANSACTION {
          string TransactionHash PK
          string AnonymizedDonorID
          float InitialHematocrit
          float TargetPurePlasmaVol
          float FinalCollectedVol
          datetime Timestamp
          string DeviceID
      }
  

Axis 5: The "Inverse" or Failure Mode

Derivative 5.1: Graceful Degradation Failsafe Mode

• Enabling Description: The system controller's (226) software includes a failsafe state machine. If the plasma collection container's weight sensor (195) provides an erratic or out-of-range reading for more than 3 consecutive polling cycles, the controller declares a sensor failure. It immediately abandons the pure-plasma calculation method (steps c, d, e of claim 1). It then switches to a "Volumetric Failsafe Mode," where it continues the collection based solely on the integrated volume of whole blood drawn, as calculated by the blood pump's (232) rotations. It stops the procedure when the total whole blood processed reaches a conservative, pre-set limit (e.g., 2000 mL) that ensures donor safety, prioritizing a safe exit from the procedure over yield optimization.
• Diagram:

  stateDiagram-v2
      state "Normal Operation" as Normal
      state "Failsafe Mode" as Failsafe
  
      [*] --> Normal
      Normal --> Normal: Weight Sensor OK
      Normal --> Failsafe: Weight Sensor Failure
      Failsafe: Stop using pure plasma target.
      Failsafe: Use whole blood volume limit.
      Failsafe --> [*]: Procedure End
  

Part 2: Combination with Open-Source Standards

Combination 2.1: HL7 FHIR Integration for Automated Parameter Input

• Enabling Description: The apheresis system's control software includes an HL7 FHIR (Fast Healthcare Interoperability Resources) client library. Prior to starting a procedure, the operator scans the donor's wristband. The system uses the donor ID to query the facility's FHIR-compliant Electronic Health Record (EHR) server. It makes a GET Patient/{id} request to retrieve the donor's weight and a GET Observation?code=20570-8 request to retrieve the most recent hematocrit lab result. These values automatically populate the parameters for steps (a) and (b) of claim 1, eliminating manual entry and transcription errors.

Combination 2.2: MQTT Protocol for Remote Fleet Monitoring

• Enabling Description: The system controller (226) runs an MQTT client service. Throughout the plasma collection process, it publishes status messages to a central MQTT broker on the facility's network. Topics include devices/{deviceID}/status (e.g., "RUNNING", "IDLE", "ERROR"), devices/{deviceID}/progress (e.g., JSON payload {"collected_ml": 550, "target_ml": 880}), and devices/{deviceID}/alerts (e.g., {"code": "A102", "message": "Low Flow"}). A central dashboard application subscribes to devices/+/+ to display a real-time overview of all devices in the collection center, enabling efficient staff allocation and proactive maintenance.

Combination 2.3: OPC UA for Industrial Process Integration

• Enabling Description: The apheresis system is exposed to the network as an OPC UA server, conforming to the open standard for industrial interoperability. The controller's variables—such as Donor Weight, Donor Hematocrit, Target Pure Plasma Volume, Target Collection Volume, Current Collected Volume, and Machine State—are mapped to nodes in the server's address space. A central SCADA (Supervisory Control and Data Acquisition) or MES (Manufacturing Execution System) can read these nodes to log process data for batch records and write to specific nodes (e.g., a "Start Procedure" node) to remotely control the device, fully integrating the plasma collection step into a larger, automated biomanufacturing workflow.