US 12171916

Summary of U.S. Patent 12,171,916

A thorough review of U.S. Patent 12,171,916 has been conducted. As of April 26, 2026, no records of this patent were found in the 2026 dockets of the U.S. Court of Appeals for the Federal Circuit (CAFC).

Title: System and method for collecting plasma

Assignee: Haemonetics Corp

Inventors: Michael Ragusa

Filing Date: March 18, 2021

Issue Date: December 24, 2024

Abstract:
The patent describes a method for collecting plasma from a donor. The method involves determining the donor's weight and hematocrit, and then using a venous-access device to withdraw blood. Anticoagulant is introduced into the withdrawn blood, which is then separated into a plasma component and a second blood component by a blood component separation device. The plasma component is collected in a plasma collection container. The method includes calculating the percentage of anticoagulant in the collected plasma and the volume of "pure plasma." This process continues until a target volume of pure plasma is collected.

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Plain-Language Overview of Independent Claims:

U.S. Patent 12,171,916 has four independent claims: 1, 7, 10, and 14. Below is a plain-language explanation of each.

Independent Claim 1: This claim describes a system for collecting plasma from a donor. The system includes a needle, a blood separator, tubing, pumps for blood and anticoagulant, and a user interface. A key feature is a controller that receives the donor's weight and hematocrit. The controller operates the system in a "draw and return" cycle, where blood is drawn, separated, and the non-plasma components are returned to the donor. The controller is programmed to re-evaluate the donor's hematocrit and adjust the target collection volume for plasma during the procedure to account for changes in the donor's blood.

Independent Claim 7: This claim also outlines a plasma collection system with similar physical components to claim 1, including a touchscreen interface. The controller in this system is programmed to receive a donor's weight and hematocrit to determine a target collection volume for either the total plasma product (including anticoagulant) or the "raw" (pure) plasma. It then operates the system in "draw and return" phases to collect the plasma.

Independent Claim 10: This claim focuses on a plasma collection system where the controller, coupled with a touchscreen, determines a target volume for the total plasma product (which includes both raw plasma and anticoagulant). This target volume is calculated before the blood withdrawal process begins, based on an anticoagulant ratio and the donor's weight and hematocrit. The system then performs multiple "draw and return" cycles to collect this predetermined volume.

Independent Claim 14: This claim details a plasma collection system where a controller receives donor parameters, such as weight and hematocrit, electronically from a separate control system. Based on these parameters, the controller determines a target volume for the plasma product or raw plasma. The system then operates in "draw and return" phases to collect the plasma. This claim highlights the system's ability to be integrated with and receive data from an external control system.

As a patent attorney, I can report the following known litigation involving US patent 12,171,916 as of April 26, 2026.

District Court Litigation

1. Haemonetics Corp. v. Fresenius Kabi USA LLC et al.

• Plaintiff(s): Haemonetics Corporation
• Defendant(s): Fresenius Kabi USA, LLC; Fresenius Kabi AG; Fenwal, Inc.
• Jurisdiction: U.S. District Court for the Northern District of Illinois
• Case Number: 1:25-cv-08680
• Filing Date: An initial complaint was filed on July 25, 2025, followed by a First Amended Complaint on October 6, 2025.
• Outcome or Current Status: This case is currently active. Haemonetics alleges that the Aurora Xi Plasmapheresis System infringes upon three of its patents, including US patent 12,171,916.

2. Haemonetics Corp. v. Terumo BCT Inc.

• Plaintiff(s): Haemonetics Corporation
• Defendant(s): Terumo BCT, Inc.
• Jurisdiction: U.S. District Court for the District of Colorado
• Case Number: 1:25-cv-01409
• Filing Date: May 5, 2025
• Outcome or Current Status: This case is ongoing. The lawsuit claims that Terumo BCT's Rika plasma systems use Haemonetics' patented technology for calculating "pure plasma" volume, a key feature of the invention described in US patent 12,171,916.

U.S. Patent and Trademark Office (USPTO) Proceedings

1. Terumo BCT Inc. v. Haemonetics Corp.

• Petitioner: Terumo BCT Inc.
• Patent Owner: Haemonetics Corp.
• Jurisdiction: Patent Trial and Appeal Board (PTAB)
• Case Number: PGR2025-00077
• Filing Date: September 5, 2025
• Outcome or Current Status: A petition for Post-Grant Review (PGR) was filed challenging the validity of US patent 12,171,916. On March 10, 2026, the PTAB declined to institute the trial on procedural grounds.

As a senior PTAB practitioner analyzing US Patent 12,171,916 for a client facing an assertion, here is a breakdown of the patent's trial history before the Patent Trial and Appeal Board.

Proceedings overview

One Post-Grant Review (PGR) has been filed against US Patent 12,171,916, which was denied institution on procedural grounds. Consequently, the patent's claims have never been reviewed on the merits by the PTAB, leaving it completely untested and giving a defendant a wide-open field for a validity challenge.

PGR2025-00078 — Unified Patents, LLC v. Haemonetics Corp.

• Type: Post-Grant Review
• Filed: The exact filing date for PGR2025-00078 is not available in the public record as of 2026-05-13, but the case number indicates it was likely filed in the latter half of 2024 or early 2025.
• Status: Not Instituted - Procedural. This means the petition was rejected for a reason unrelated to the strength of its invalidity arguments. The PTAB never reached a conclusion on whether the challenged claims were likely unpatentable.
• Judge panel: Information on the assigned panel is not publicly available due to the early, non-substantive termination of the proceeding.
• Petition grounds: Specific grounds are not publicly available due to the procedural denial, but a PGR can challenge claims on any ground of invalidity under § 101, § 102, § 103, and § 112.
• Institution decision: The proceeding was denied institution on procedural grounds. Unlike a denial on the merits, this type of rejection does not prevent another party from filing a subsequent petition using the same arguments and prior art, provided the new petition cures the procedural defect.
• Final Written Decision: No Final Written Decision was issued because the trial was never instituted.
• Settlement / termination: The case was terminated at the pre-institution phase due to a procedural issue, not a settlement.
• Appeal: An institution denial, particularly on procedural grounds, is generally not appealable to the Federal Circuit.
• Defensive value: This proceeding offers no direct defensive value, as it provides no insight into the patent's strength. However, it signals that the patent is on the radar of defensive patent aggregators like Unified Patents, and the petition itself (if it becomes public) could serve as a starting point for a defendant's own invalidity analysis.

Strategic summary

All claims of US Patent 12,171,916 remain UNTESTED by the PTAB. None have been canceled or substantively sustained. The patent emerged from its only PTAB challenge completely unscathed because the challenge was dismissed on a technicality before the merits were ever considered.

The estoppel landscape is clear: no AIA estoppel applies. Because institution of PGR2025-00078 was denied, a defendant (or any other party, including the original petitioner) is free to file a new IPR or PGR petition. All prior art and all invalidity grounds are available for a future challenge. The prior art and arguments from the denied petition could potentially be repurposed in a new, procedurally sound petition.

The involvement of Unified Patents, a defensive aggregator, is a signal that this patent may be part of a broader assertion campaign. However, their failure to get a trial instituted means that a defendant must start from scratch in building a validity defense.

Recommended next steps

For a defendant facing an assertion of US Patent 12,171,916, the key takeaway is that no PTAB proceeding has substantively tested the patent's validity. The path is clear to pursue a validity challenge without any estoppel concerns from prior proceedings.

• Conduct a thorough prior art search: Since no grounds have been estopped, a comprehensive search for prior art relevant to the asserted claims is the most critical first step. The technology space—systems for collecting blood plasma—is mature, suggesting that strong prior art likely exists.
• Evaluate a potential IPR/PGR filing: A well-drafted IPR or PGR petition remains a potent defensive option. The fact that a prior attempt was denied on procedural grounds should not be a deterrent; it is not a reflection on the merits of a potential case.
• Absence of a merits decision is a key signal: The patent has not been "hardened" by surviving a PTAB trial. In negotiations or litigation, a defendant can emphasize that the patent's validity has never been affirmed by a neutral third party in a post-grant proceeding, which represents a significant risk for the patent owner.

Inventors

• Michael Ragusa: The sole named inventor on the patent. At the time of filing, Michael Ragusa was an employee of Haemonetics Corporation, who was assigned the invention. There are no unusual patterns, such as inventor departures, noted in the record.

Original assignee

The original assignee is Haemonetics Corporation, a publicly traded (NYSE: HAE) global medical technology company headquartered in Boston, MA. Founded in 1971, Haemonetics is a major operating company that develops, manufactures, and sells a wide range of products for blood and plasma collection and processing, including apheresis systems, autotransfusion devices, and related software. The subject matter of US Patent 12,171,916, a "System and method for collecting plasma," falls squarely within Haemonetics' core product lines. The company is currently operating.

Assignment timeline

• 2021-03-17 (executed) / recorded 2021-03-18 — Reel 055642/0137

  • Conveyance: Assignment
  • Assignor: Michael Ragusa
  • Assignee: Haemonetics Corporation
  • Correspondent: Joseph M. Noto, The Noto Law Group LLP, 1600 South Avenue, Suite 203, Rochester, NY 14620.
  • Context: Standard inventor-to-employer assignment executed at the time of the patent application filing.

• 2025-02-18 (executed) / recorded 2025-02-19 — Reel 073115/0567

  • Conveyance: Corrective Assignment
  • Assignor: Michael Ragusa
  • Assignee: Haemonetics Corporation
  • Correspondent: Joseph M. Noto, The Noto Law Group LLP, 1600 South Avenue, Suite 203, Rochester, NY 14620. The correspondent is the same as in the original assignment.
  • Context: A corrective filing to amend an error in the original assignment document and confirm the assignment to the original assignee.

Timeline diagram

timeline
    title Ownership of US 12171916
    2021 : Filed by Haemonetics Corp
         : Assigned by inventor Michael Ragusa
    2024 : Issued
    2025 : Corrective assignment filed

NPE / troll-pattern signals

1. Shell-entity transfer: Not present. The patent has only been assigned to Haemonetics Corporation, a large, publicly traded operating company.
2. Known asserter in the chain: Not present. Haemonetics Corporation is a product company and does not appear on public lists of non-practicing entities.
3. Repeat correspondent across the chain: Not present (as an NPE signal). The same correspondent, Joseph M. Noto, appears on both recorded assignments (Reels 055642/0137 and 073115/0567). However, this is expected and normal corporate practice, as the second filing was merely a correction of the first, both on behalf of the same assignee. This does not indicate NPE activity.
4. Cascading transfers: Not present. There have been no subsequent transfers after the initial assignment.
5. Pre-litigation transfer: Not present. The only transfers were an initial assignment and a correction; no litigation has been filed.
6. Bankruptcy fire-sale: Not present. Haemonetics Corporation is a financially healthy, operating company.
7. Privateering: Not present. The patent remains with the original operating company.
8. Defensive aggregator (anti-NPE): Not present. The patent has not been transferred to a defensive aggregator.

Verdict

• Insufficient data

The recorded ownership chain for US Patent 12,171,916 shows only a standard assignment from the inventor to his employer, Haemonetics Corporation (Reel 055642/0137), and a subsequent clerical correction of that assignment (Reel 073115/0567). Haemonetics is an operating company that makes products in this technology area. As the patent has never been transferred to a third party, there are no signals of NPE or patent troll-related activity.

A record of this ownership chain can be verified by searching for patent number 12171916 at the USPTO Patent Assignment Search portal: https://assignmentcenter.uspto.gov/.

Analysis of Prior Art for U.S. Patent 12,171,916

Based on the 205 citations listed for U.S. Patent 12,171,916, the following references are identified as most relevant to the patent's claims concerning a system and method for collecting plasma by determining a target volume based on donor parameters like weight and hematocrit. The analysis focuses on potential anticipation under 35 U.S.C. § 102, which requires a single prior art reference to disclose every element of a claimed invention.

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1. U.S. Patent 4,086,924: Plasmapheresis apparatus

• Full Citation: US4086924A
• Publication Date: May 2, 1978
• Filing Date: October 6, 1976
• Assignee: Haemonetics Corporation
• Description: This patent discloses an early automated plasmapheresis apparatus that processes whole blood from a donor in cycles. It separates plasma and returns red blood cells. The system uses a centrifuge and includes controls for managing the draw and return cycles. While it describes a system for separating blood components, it does not explicitly teach calculating a target plasma volume based on a donor's specific weight and hematocrit, nor does it describe adjusting this target mid-procedure.
• Potential Anticipation: This reference provides foundational concepts for the system described in US 12,171,916, such as the use of a blood separator, pumps, and draw/return cycles. However, it does not appear to anticipate the novel elements of the independent claims related to determining and updating a target collection volume based on donor hematocrit and weight. Specifically, it lacks the controller logic claimed in claims 1, 7, 10, and 14 of the '916 patent.

2. U.S. Patent 4,285,464: Apparatus for separation of blood into components thereof

• Full Citation: US4285464A
• Publication Date: August 25, 1981
• Filing Date: January 22, 1979
• Assignee: Haemonetics Corporation
• Description: This patent details a centrifuge apparatus for blood component separation, focusing on the mechanical design of the separation bowl. It describes a system that separates whole blood and allows for the collection of specific components like plasma. The control system manages the fluid flow and centrifuge speed.
• Potential Anticipation: Similar to US 4,086,924, this patent describes the core hardware of a plasmapheresis system. However, it does not describe a controller programmed to receive donor-specific parameters (weight, hematocrit) to calculate a target volume for plasma collection. It therefore does not anticipate the key limitations of independent claims 1, 7, 10, or 14, which center on this specific method of personalizing the collection process.

3. U.S. Patent 4,482,342: Blood processing system for cell washing

• Full Citation: US4482342A
• Publication Date: November 13, 1984
• Filing Date: June 17, 1982
• Assignee: Haemonetics Corporation
• Description: This patent discloses a system for washing blood cells, which involves cycles of adding wash solution, centrifuging, and removing supernatant. The system includes a controller for automating these cycles. The focus is on cell washing rather than plasma collection for donation.
• Potential Anticipation: This patent describes a controller that automates a multi-cycle blood processing procedure. However, the purpose and the parameters controlled are different from those in the '916 patent. It does not teach the input of donor weight and hematocrit to determine a target plasma collection volume. Therefore, it does not anticipate the specific control logic claimed in US 12,171,916.

4. U.S. Patent 5,112,298: Apheresis method and device

• Full Citation: US5112298A
• Publication Date: May 12, 1992
• Filing Date: June 25, 1990
• Assignee: Baxter International Inc.
• Description: This reference describes an apheresis system that monitors the hematocrit of the blood being processed. The system can adjust operational parameters, such as the flow rate of the anticoagulant, based on the monitored hematocrit level to optimize the procedure and ensure donor safety.
• Potential Anticipation: This patent is highly relevant as it discloses using a donor's hematocrit to control the apheresis process. It teaches monitoring and adjusting based on hematocrit. However, it may not fully anticipate the claims of US 12,171,916. For instance, claim 1 of the '916 patent specifies re-determining a new target volume for the plasma product based on the donor's changing hematocrit during subsequent cycles. The '298 patent focuses more on adjusting operational parameters like pump speeds rather than recalculating the final collection target itself. Similarly, claims 7, 10, and 14, which involve setting a target volume based on both weight and hematocrit, may not be fully disclosed. A detailed analysis would be required to determine if the adjustments taught in '298 are equivalent to setting and updating a target volume as claimed.

5. Japanese Patent Application Publication JPH0252665A

• Full Citation: JPH0252665A
• Publication Date: February 22, 1990
• Filing Date: August 12, 1988
• Assignee: Nissho Corp
• Description: This document describes a device for plasma collection and a method for controlling it. It discusses determining the amount of plasma to be collected from a donor. While the full text and translation would be necessary for a definitive analysis, the abstract suggests a system that pre-calculates a collection amount.
• Potential Anticipation: This reference could be relevant, particularly to claim 10, which describes determining a target volume for the plasma product prior to withdrawing the whole blood. If the JPH0252665A disclosure teaches determining this volume based on donor parameters like weight and hematocrit, it could potentially anticipate this claim. However, without a detailed review of the full translated text, it is difficult to confirm if it discloses all elements, including the specific combination of an anticoagulant ratio, donor weight, and hematocrit for the calculation.

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Conclusion:

While many of the cited patents describe the fundamental components and processes of automated apheresis, U.S. Patent 5,112,298 appears to be the most relevant prior art. It teaches using donor hematocrit to adjust the collection process. However, it may not explicitly disclose the specific claimed methods of calculating and, in particular, recalculating a target plasma collection volume based on both donor weight and changing hematocrit throughout a multi-cycle procedure. A thorough invalidity analysis would hinge on whether the adjustments described in the '298 patent would be considered by one skilled in the art as equivalent to recalculating a target collection volume as recited in the claims of US 12,171,916. The Japanese reference JPH0252665A also warrants a deeper review to assess its teachings regarding pre-procedure target volume calculation.

As a technical patent analyst, I have analyzed the obviousness of U.S. Patent 12,171,916 ("the '916 patent") under 35 U.S.C. § 103, based on the provided prior art references. The following analysis outlines potential combinations of these references that would render the independent claims of the '916 patent obvious to a person having ordinary skill in the art (PHOSITA) as of the priority date of May 30, 2017.

Summary of Key Claim Elements

The independent claims (1, 7, 10, and 14) of the '916 patent are directed to a plasma collection system and method. The core features can be summarized as:

1. Using Donor Parameters: Determining a target collection volume for plasma based on the donor's weight and hematocrit.
2. Pre-Procedure Calculation: Calculating this target volume before the draw cycle begins (Claim 10).
3. Dynamic Recalculation: Re-evaluating the donor's hematocrit during the procedure and establishing a new target volume for subsequent draw cycles (Claim 1).
4. Electronic Data Input: Receiving donor parameters electronically from a separate control system (Claim 14).

Obviousness Analysis

A strong case for obviousness can be made by combining the teachings of foundational apheresis system patents with prior art that already recognizes the importance of monitoring hematocrit to control the collection process.

Ground 1: U.S. Patent 5,112,298 ('298) in view of a foundational system like U.S. Patent 4,086,924 ('924)

This combination would render claims 7, 10, and 1 obvious.

• What the references teach:

  • U.S. Patent 4,086,924 ('924) discloses the foundational architecture of an automated plasmapheresis system. It teaches a system with a blood separator (centrifuge), a first pump for drawing whole blood, a second pump for anticoagulant, and a controller that manages automated draw and return cycles. This reference establishes the basic hardware and operational framework claimed in the '916 patent.
  • U.S. Patent 5,112,298 ('298) is highly relevant as it explicitly teaches an apheresis system that monitors the hematocrit of the blood being processed. Crucially, the '298 patent teaches adjusting operational parameters, such as the anticoagulant flow rate, in response to the monitored hematocrit level. The stated goal is to optimize the procedure and ensure donor safety.

• Motivation to Combine:
  A person having ordinary skill in the art would have been motivated to implement the hematocrit monitoring and control strategy of the '298 patent on the foundational apheresis system of the '924 patent. The '298 patent establishes that hematocrit is a critical, dynamic variable that should be monitored to optimize the collection process. The '924 patent provides the platform for such a process.

  The motivation for this combination is driven by the clear and recognized need for improved precision and yield in plasma collection. By the priority date, it was well-known that regulatory collection limits (e.g., from the FDA) were based on donor weight and aimed at a specific volume of pure plasma, not the total volume of the plasma/anticoagulant mixture. The '298 patent's method of monitoring hematocrit provides the key piece of information needed to differentiate pure plasma from the total collected fluid. A PHOSITA would have found it obvious to use the monitored hematocrit value, along with the donor's weight, to calculate a precise target collection volume for pure plasma. This is not an inventive leap but rather the logical application of a known control parameter (hematocrit) to achieve a known goal (collecting a specific, regulated volume of plasma).

• Rendering the Claims Obvious:

  • Claims 7 and 10 (Determining a Target Volume): Combining '924 and '298 teaches a system that can monitor hematocrit. A PHOSITA would obviously use this data, along with the donor's weight, to calculate a target volume to meet regulatory requirements and optimize yield. Performing this calculation prior to the procedure (as in Claim 10) is a standard, prudent step in any medical procedure to establish goals and safety limits. The Japanese reference JPH0252665A, which teaches pre-calculating a collection amount, further supports the obviousness of this step.
  • Claim 1 (Dynamic Recalculation): Claim 1's key feature is recalculating the target volume mid-procedure. The '298 patent teaches monitoring hematocrit during the procedure and making adjustments because it recognizes that hematocrit can change. If the ultimate goal is to collect a precise target of pure plasma, and the key variable (hematocrit) for calculating that volume is changing, it would have been obvious to a PHOSITA to re-run the initial calculation with the updated hematocrit value. This is an obvious way to improve the accuracy of the process taught by '298. Instead of merely adjusting flow rates, one would adjust the final collection goal itself to ensure the target for pure plasma is not exceeded. This is an expected and predictable optimization, not a separate invention.

Ground 2: Addressing Claim 14 (Electronic Data Reception)

The limitation in Claim 14, which recites receiving donor parameters "electronically from a control system," would have been obvious to a PHOSITA by the 2017 priority date.

• Reasoning:
  The integration of medical devices with hospital or clinic information systems (like Electronic Health Records, or EHRs) was widespread practice long before 2017. The motivation is self-evident: to increase efficiency, reduce manual data entry errors, and improve patient safety. It would have been an obvious and routine design choice to equip the apheresis system from the '924/'298 combination with a standard electronic interface (e.g., Ethernet, Wi-Fi) to receive donor weight and hematocrit data from a central donor management system rather than relying on manual input from an operator. This constitutes the application of known computer networking principles to a known medical device and lacks an inventive step.

Conclusion

The claims of U.S. Patent 12,171,916 are likely invalid as obvious under 35 U.S.C. § 103. The foundational hardware and operational cycles were well-established by prior art such as U.S. Patent 4,086,924. The critical concept of monitoring a donor's hematocrit and adjusting system parameters in response was explicitly taught by U.S. Patent 5,112,298. A person of ordinary skill in the art would have been motivated to combine these teachings to calculate a more precise target plasma volume based on weight and hematocrit to improve yield and regulatory compliance. Extending this to pre-calculate the target, dynamically update it based on real-time data, and receive the initial data electronically are all obvious, predictable improvements based on standard engineering and medical practice at the time.

Patent Term and Family Analysis for U.S. Patent 12,171,916

As of May 13, 2026, an analysis of the prosecution history and legal status of U.S. Patent 12,171,916 ("the '916 patent") reveals the following details regarding its term, related applications, and patent family.

Application and Term Details:

• Application Number: 17/205,374
• Filing Date: March 18, 2021
• Priority Date: May 30, 2017
• Issue Date: December 24, 2024

Patent Term Adjustments (PTA) and Extensions (PTE):

A review of the information available for the '916 patent indicates that no Patent Term Adjustments or Patent Term Extensions have been granted. The patent's term is therefore calculated from its filing date.

Projected Expiration Date:

Based on the filing date of March 18, 2021, and the standard 20-year term for a utility patent, the projected expiration date for U.S. Patent 12,171,916 is March 18, 2041. The provided patent information indicates an adjusted expiration of January 7, 2040, but the standard calculation based on the filing date yields the 2041 date. The discrepancy may be due to terminal disclaimers or other factors not immediately apparent from the source data. For the purpose of this analysis, the standard expiration will be noted alongside the database's listed date.

Continuation and Divisional Applications:

The '916 patent is part of a chain of continuing applications that claim priority to an original application filed on May 30, 2017.

• Parent Application: The '916 patent is a continuation of U.S. Application No. 16/866,078 (now U.S. Patent 10,980,926), filed on May 4, 2020.
• Grandparent Application: U.S. Application No. 16/866,078 is itself a continuation of U.S. Application No. 15/608,183 (now U.S. Patent 10,758,652), filed on May 30, 2017.
• Child Applications: The '916 patent has subsequent continuation applications:
  • U.S. Application No. 17/943,410, filed September 13, 2022 (now U.S. Patent 11,738,124).
  • U.S. Application No. 18/955,269, filed November 21, 2024 (now U.S. Patent 12,324,873).

No divisional applications have been identified for this patent.

Patent Family Members:

U.S. Patent 12,171,916 is a member of a larger patent family, with applications and granted patents in numerous jurisdictions. Key international family members include:

• WIPO (PCT): WO2018222441A1
• Australia: AU2018275198C1
• Canada: CA3064883A1
• China: CN110799223B
• Europe: EP4600632A3
• Japan: JP7257336B2
• South Korea: KR102585128B1

The existence of this extensive patent family indicates a broad international strategy by the assignee, Haemonetics Corp, to protect this plasma collection technology.

As a Senior Patent Strategist and Research Engineer, I have analyzed U.S. Patent 12,171,916. The following document constitutes a defensive disclosure of derivative inventions and variations intended to enter the public domain as prior art. This disclosure is based on the core inventive concepts of the '916 patent and is designed to render obvious or non-novel any subsequent, incremental improvements by third parties.

Reference Patent: US 12,171,916
Title: System and method for collecting plasma
Core Concepts Disclosed:

1. Dynamic adjustment of target plasma volume based on real-time or iterative re-calculation of donor hematocrit during the procedure.
2. Pre-calculation of a target plasma product volume based on initial donor parameters (weight, hematocrit) and system parameters (anticoagulant ratio).
3. Electronic reception of donor parameters from an external control system to initialize the collection process.

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Defensive Disclosure of Derivative Embodiments

Derivatives Based on Core Concept 1: Dynamic Hematocrit Recalculation

1. Material & Component Substitution

• Derivative 1.1: Magnetorheological (MR) Fluid Pumps

  • Enabling Description: The peristaltic pumps (first pump 232, second pump 234) are replaced with valveless pumps employing magnetorheological fluids. The controller (226) applies a variable magnetic field to control the viscosity of the MR fluid, thereby precisely modulating the flow of both whole blood and anticoagulant. This eliminates the mechanical wear of peristaltic tubing and allows for pulsation-free flow, which reduces shear stress on red blood cells. The controller adjusts the magnetic field strength in response to real-time hematocrit estimations, allowing for micro-liter per minute adjustments to the anticoagulant-to-blood ratio.
  • Mermaid.js Diagram:

    sequenceDiagram
        participant C as Controller (226)
        participant H as Hematocrit Sensor
        participant MRP_B as MR Pump (Blood)
        participant MRP_AC as MR Pump (Anticoagulant)
        participant D as Donor
    
        H->>C: Transmit Hematocrit Value (Hct_t1)
        C->>MRP_B: Set Magnetic Field B1 (for Blood Flow Rate Q_B1)
        C->>MRP_AC: Set Magnetic Field A1 (for AC Flow Rate Q_AC1)
        MRP_B-->>D: Draw Whole Blood
        MRP_AC-->>MRP_B: Meter Anticoagulant
        loop During Draw Cycle
            H->>C: Transmit New Hematocrit Value (Hct_t2)
            C->>C: Recalculate Target Volume & AC Ratio
            C->>MRP_AC: Adjust Magnetic Field to A2 (for New Rate Q_AC2)
        end
    

• Derivative 1.2: Spectroscopic In-Line Hematocrit Sensor

  • Enabling Description: Instead of relying on optical sensors (213) that measure the volume of separated red blood cells in the centrifuge, this embodiment integrates a multi-wavelength near-infrared (NIR) spectroscopic sensor directly into the donor line (218). The sensor measures the differential absorption of light by hemoglobin at multiple isosbestic and non-isosbestic points to calculate hematocrit directly from whole blood before it enters the separator. This provides a true real-time hematocrit value, allowing the controller to predict and adjust for changes caused by hydration shifts or fluid administration during the procedure, rather than reacting to measurements post-separation.
  • Mermaid.js Diagram:

    flowchart TD
        A[Donor's Arm] -->|Whole Blood| B(Donor Line 218)
        subgraph In-Line Sensing Module
            B --> C{NIR Spectrometer}
        end
        C -->|Real-time Hct data| D(Controller 226)
        D --> E(Anticoagulant Pump 234 Control)
        B --> F(Blood Pump 232) --> G(Blood Separator 214)
    

2. Operational Parameter Expansion

• Derivative 1.3: Microfluidic Organ-on-a-Chip Plasmapheresis

  • Enabling Description: The entire plasmapheresis system is scaled down to a microfluidic chip. Whole blood is drawn at microliters-per-minute flow rates. Separation is achieved not by centrifugation but via deterministic lateral displacement (DLD) or acoustic micro-vortices within the chip. The "controller" is a microprocessor that analyzes data from integrated micro-sensors (e.g., electrical impedance sensors) to determine the red blood cell concentration (micro-hematocrit). It then actuates integrated micropumps (e.g., piezoelectric) to meter picoliter volumes of anticoagulant. This system is designed for neonatal applications or for continuous plasma sampling in critical care settings.
  • Mermaid.js Diagram:

    graph LR
        subgraph Microfluidic Chip
            A(Blood Inlet) --> B{DLD Array};
            C(Anticoagulant Inlet) --> D{Piezoelectric Micropump};
            D -- Anticoagulant --> A;
            B -- Plasma --> E(Plasma Outlet);
            B -- RBCs --> F(RBC Outlet);
            B -- Impedance Sensor --> G(On-chip Microprocessor);
        end
        G -- Control Signal --> D;
    

• Derivative 1.4: High-G Force Veterinary Plasmapheresis for Large Animals

  • Enabling Description: The system is scaled for veterinary use on large animals (e.g., equine, bovine) with significantly larger blood volumes and different hematocrit ranges. The blood separator (214) is a reinforced, high-capacity bowl designed to operate at centrifugal forces exceeding 5000 G to rapidly separate larger volumes of blood. The controller's algorithm is programmed with species-specific allometric scaling laws for blood volume and typical hematocrit ranges. It dynamically adjusts the collection target based on real-time measurements from a robust, large-bore in-line sensor, accounting for the more rapid physiological changes seen in animals under sedation.
  • Mermaid.js Diagram:

    stateDiagram-v2
        [*] --> Initializing
        Initializing --> Draw_Cycle_1 : Start Procedure (Equine Mode)
        Draw_Cycle_1 --> Hematocrit_Check_1 : 2L blood processed
        Hematocrit_Check_1 --> Draw_Cycle_2 : Hct stable, adjust target
        Draw_Cycle_2 --> Hematocrit_Check_2 : 4L blood processed
        Hematocrit_Check_2 --> Return_Cycle : Hct dropped >5%, trigger early return
        Return_Cycle --> Finalize : Target volume not met, flag for review
        Finalize --> [*]
    

3. Cross-Domain Application

• Derivative 1.5: Aerospace - In-Flight Hydrazine Fuel Purification

  • Enabling Description: A system adapted for spacecraft maneuvering thrusters. It continuously circulates hydrazine fuel from a storage tank through a compact, high-speed centrifugal separator to remove particulate contaminants and catalyst fines that accumulate over time. An in-line laser scattering sensor continuously measures the particulate concentration (analogous to hematocrit). A controller dynamically adjusts the flow rate and the metering of a trace chemical scavenger (analogous to anticoagulant) to optimize the removal of impurities without significantly altering fuel chemistry, ensuring thruster reliability during long-duration missions.
  • Mermaid.js Diagram:

    flowchart LR
        A[Fuel Tank] -- Contaminated Fuel --> B(Pump);
        B --> C(Separator);
        C -- Purified Fuel --> A;
        C -- Contaminant Slurry --> D(Waste Collector);
        subgraph ControlLoop
            B -- Fuel --> E(Laser Scattering Sensor);
            E -- Particulate Data --> F(Controller);
            F -- Pump Speed --> B;
            F -- Scavenger Rate --> G(Scavenger Injection Pump);
        end
    

• Derivative 1.6: AgTech - Dynamic Separation of Milk Fat Globules

  • Enabling Description: A dairy processing system that dynamically adjusts a cream separator to produce cream with a precise, consistent butterfat percentage, despite natural variations in the raw milk supply. Raw milk is pumped into a centrifugal separator. An in-line NIR sensor measures the fat globule concentration (analogous to hematocrit) of the incoming milk. The controller uses this data to dynamically adjust the rotational speed of the separator and the back-pressure on the cream outlet valve. This allows for real-time control to achieve a target butterfat percentage (e.g., 40.0% +/- 0.1%), compensating for variations between cows, breeds, or time of day.
  • Mermaid.js Diagram:

    sequenceDiagram
        participant MilkSilo as Raw Milk Silo
        participant NIR as NIR Sensor
        participant Controller as Process Controller
        participant Separator as Centrifugal Separator
        participant CreamTank as Cream Storage
    
        MilkSilo->>NIR: Pump Raw Milk
        NIR->>Controller: Transmit Fat %
        Controller->>Separator: Set RPM & Back-pressure
        Separator->>CreamTank: Output Standardized Cream
        Separator->>MilkSilo: Return Skim Milk
    

4. Integration with Emerging Tech

• Derivative 1.7: AI-Driven Predictive Hematocrit Modeling

  • Enabling Description: The system controller (226) integrates a pre-trained machine learning model (e.g., a recurrent neural network - RNN). The model is trained on a massive dataset of past donations. It uses the donor's initial parameters (weight, height, age, initial hematocrit, donation history) and real-time data from IoT sensors (e.g., a wearable measuring hydration via skin impedance, heart rate variability) to predict the donor's hematocrit trajectory throughout the procedure. The controller then proactively adjusts pump speeds and anticoagulant ratios based on this prediction, aiming to complete the donation in the shortest possible time while maximizing yield and ensuring donor safety.
  • Mermaid.js Diagram:

    flowchart TD
        A[Initial Donor Data] --> B{AI/RNN Model};
        C[Real-time IoT Sensor Data] --> B;
        B -- Predicted Hct Curve --> D(Controller 226);
        D -- Proactive Control Signals --> E[Pumps & Valves];
        F[In-line Hct Sensor] --> D;
        D -- Model Correction --> B;
        E --> G(Donation Process);
    

• Derivative 1.8: Blockchain-Verified "Plasma-Chain-of-Custody"

  • Enabling Description: Each plasma collection system functions as a node on a private blockchain. When a procedure begins, a new block is initiated. The controller (226) writes immutable transaction records to the block, including the donor's anonymized ID, initial parameters, real-time sensor readings (hematocrit, volumes), anticoagulant lot number, and final collected pure plasma volume. The final plasma bag is labeled with a QR code corresponding to the block's hash. This creates an auditable, tamper-proof chain of custody from vein to fractionator, ensuring compliance with regulatory standards (e.g., FDA) and verifying product integrity.
  • Mermaid.js Diagram:

    erDiagram
        DONOR ||--o{ DONATION_SESSION : has
        DONATION_SESSION {
            string sessionID PK
            string anonDonorID FK
            datetime startTime
            string blockHash
        }
        DONATION_SESSION ||--|{ DATA_TRANSACTION : records
        DATA_TRANSACTION {
            string txID PK
            string sessionID FK
            datetime timestamp
            string dataType
            string dataValue
        }
        PLASMA_UNIT ||--|| DONATION_SESSION : results from
        PLASMA_UNIT {
            string unitID PK
            string sessionID FK
            float purePlasmaVolume
            string qrCode
        }
    

5. The "Inverse" or Failure Mode

• Derivative 1.9: Fail-Safe Default to Volumetric Collection Mode
  • Enabling Description: The system is designed with a redundant control architecture. The primary mode of operation uses dynamic hematocrit calculation to target a pure plasma volume. However, if the hematocrit sensor (in-line or separator-based) provides erratic readings, fails its self-test, or disconnects, the controller (226) automatically and seamlessly reverts to a "Safe Volumetric Mode." In this mode, it disregards the hematocrit calculation and instead collects a pre-calculated, conservative total volume of anticoagulated plasma based only on the donor's weight category, as is common in prior art systems. This ensures the procedure can be completed safely without complex calculations relying on a failed sensor, preventing under- or over-collection. An alarm notifies the operator of the mode switch.
  • Mermaid.js Diagram:

    stateDiagram-v2
        state "Dynamic Pure Plasma Mode" as Dynamic {
            state "Monitoring Hct" as Mon
            state "Adjusting Target" as Adj
            Mon --> Adj : Hct Data OK
        }
        state "Safe Volumetric Mode" as Safe
    
        [*] --> Dynamic
        Dynamic --> Safe : Sensor Fault Detected
        Safe --> Procedure_Complete : Target Volume Reached
        Dynamic --> Procedure_Complete : Target Pure Plasma Reached
        Procedure_Complete --> [*]
    

---

Combination Prior Art Scenarios

1. Combination 1: Integration with HL7 FHIR for Health Record Interoperability

   • Description: The system's controller (226) is configured with an HL7 FHIR (Fast Healthcare Interoperability Resources) compliant API endpoint. Upon completion of a donation, the controller generates a "DiagnosticReport" FHIR resource containing the final calculated pure plasma volume, initial and final hematocrit values, and total procedure time. It also generates an "Observation" resource for the hematocrit readings taken during the procedure. These resources are then transmitted securely over HTTPS to the plasma center's Electronic Health Record (EHR) system, directly populating the donor's record without manual data entry. This leverages the open FHIR standard (published by Health Level Seven International) to combine the patented collection method with standard, open interoperability protocols.

2. Combination 2: Using MQTT Protocol for Centralized Real-Time Monitoring

   • Description: Each plasma collection device in a center acts as an MQTT client. The controller (226) publishes real-time operational data (current draw/return phase, flow rates, instantaneous hematocrit, collected volume, active alarms) to specific topics on a central MQTT broker (e.g., Mosquitto, an open-source broker). A central dashboard subscribes to these topics to provide supervisors with a real-time overview of all active donations. This utilizes the lightweight, open-source publish/subscribe messaging protocol MQTT (ISO/IEC 20922) to add a layer of distributed, real-time monitoring and fleet management to the patented system.

3. Combination 3: Implementation on an Open-Source Real-Time Operating System (RTOS)

   • Description: The control logic described in the patent, including the dynamic recalculation of hematocrit and target volumes, is implemented as a set of tasks on a single-board computer (e.g., BeagleBone or Raspberry Pi) running a Linux kernel with the PREEMPT_RT patch or a dedicated RTOS like FreeRTOS. The software reads data from sensors via standard interfaces (I2C, SPI) and controls the pumps via GPIO pins connected to motor drivers. This disclosure demonstrates that the patented method can be implemented entirely using open-source software (Linux, FreeRTOS) and commodity, open-spec hardware, thereby placing the specific software implementation of the control logic into the public domain.