US 11738124

Technical Analysis of U.S. Patent 11,738,124

Date of Analysis: May 13, 2026

This report provides a concise summary of United States Patent 11,738,124, including its key bibliographic details and a plain-language overview of its independent claims.

Bibliographic Information

• Title: System and method for collecting plasma.
• Assignee: Haemonetics Corporation.
• Inventor: Michael Ragusa.
• Filing Date: September 13, 2022.
• Issue Date: August 29, 2023.
• Abstract: A method for collecting plasma includes determining the weight and hematocrit of a donor, and inserting a venous-access device into the donor. The method then withdraws blood from the donor through a draw line connected to a blood component separation device, and introduces anticoagulant into the withdrawn blood. The blood component separation device separates the blood into a plasma component and a second blood component, and the plasma component is collected from the blood component separation device and into a plasma collection container. The method may then calculate (1) a percentage of anticoagulant in the collected plasma component, and (2) a volume of pure plasma collected within the plasma collection container. The volume of pure plasma may be based, at least in part, on the calculated percentage of anticoagulant. The method may continue until a target volume of pure plasma is collected within the plasma collection container.

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Plain-Language Overview of Independent Claims

U.S. Patent 11,738,124 contains two independent claims: claim 1, which describes a method, and claim 11, which describes a system.

• Independent Claim 1 (Method): This claim outlines a method for collecting plasma from a donor. The key steps are:

  1. Determining the donor's weight and hematocrit (the proportion of red blood cells in their blood).
  2. Drawing whole blood from the donor.
  3. Mixing the drawn blood with an anticoagulant.
  4. Separating the anticoagulated blood into plasma and other blood components.
  5. Collecting the separated plasma component.
  6. Crucially, the method involves calculating the actual volume of anticoagulant that is present in the collected plasma.
  7. Based on this, it then calculates the volume of "pure plasma" (plasma without the anticoagulant).
  8. The process is repeated until a specific target volume of this pure plasma is collected.

  In essence, this method aims to collect a more precise and standardized amount of pure plasma from each donor, regardless of individual variations in their hematocrit, by accounting for the volume of anticoagulant added during the process.

• Independent Claim 11 (System): This claim describes the physical system designed to carry out the method of claim 1. The system consists of:

  1. A venous-access device (like a needle) to draw blood and return other components to the donor.
  2. A blood component separation device (e.g., a centrifuge) to separate plasma from other blood parts.
  3. Tubing (a blood draw line and an anticoagulant line) to transport the fluids.
  4. Pumps to control the flow of blood.
  5. A central controller (a computer) that operates the system.

  The inventive feature of the system lies in the controller's programming. It is configured to calculate the volume of anticoagulant in the collected plasma (based on the donor's hematocrit) and then determine the volume of pure plasma. The controller is programmed to automatically stop the collection process once a predetermined target volume of pure plasma has been reached.

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Legal Status and Proceedings

As of the date of this analysis, it is important to note that U.S. Patent 11,738,124 is the subject of post-grant proceedings. An Inter Partes Review (IPR) was instituted by Terumo BCT, Inc. against Haemonetics Corporation (Case IPR2025-01374) at the Patent Trial and Appeal Board (PTAB). The institution date was January 27, 2026. An IPR is a trial proceeding conducted at the USPTO to review the patentability of one or more claims of a patent. The outcome of this proceeding could affect the validity of the claims described above. No dockets related to this patent were found for the Court of Appeals for the Federal Circuit (CAFC) for 2026 at this time.

Litigation Surrounding US Patent 11,738,124 for Plasma Collection Technology

As of April 26, 2026, US patent 11,738,124, assigned to Haemonetics Corporation, is the subject of at least two legal challenges: a patent infringement lawsuit in federal district court and an Inter Partes Review (IPR) proceeding before the Patent Trial and Appeal Board (PTAB).

District Court Litigation:

Haemonetics Corporation has asserted its rights under the '124 patent in a lawsuit filed in the United States District Court for the District of Colorado.

• Plaintiff: Haemonetics Corporation
• Defendant: Terumo BCT, Inc.
• Jurisdiction: U.S. District Court for the District of Colorado
• Case Number: 1:25-cv-01409
• Filing Date: May 5, 2025
• Status: Active. The suit alleges patent infringement by Terumo BCT.

Patent Trial and Appeal Board (PTAB) Proceeding:

In addition to the district court case, the validity of US patent 11,738,124 is being challenged at the U.S. Patent and Trademark Office's Patent Trial and Appeal Board.

• Petitioner: Terumo BCT, Inc.
• Patent Owner: Haemonetics Corporation
• Jurisdiction: USPTO Patent Trial and Appeal Board
• Case Number: IPR2025-01374
• Filing Date: August 4, 2025
• Status: The PTAB instituted the Inter Partes Review on January 27, 2026, indicating that the petitioner, Terumo BCT, Inc., established a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the petition. The proceeding is currently pending before the board.

As a senior PTAB practitioner analyzing US Patent 11,738,124 for a client facing an assertion, the patent's validity is currently under a significant, pending challenge at the Patent Trial and Appeal Board (PTAB). While your internal data may not yet reflect this, a live proceeding has been instituted, which materially improves a defendant's strategic position.

Here is a detailed assessment of the PTAB landscape for this patent.

Proceedings Overview

One inter partes review (IPR) is currently active against US Patent 11,738,124; the PTAB has instituted trial, signifying that the petitioner established a reasonable likelihood of prevailing on at least one challenged claim. This pending challenge significantly weakens the patent's presumption of validity and provides a defendant with substantial defensive leverage.

IPR2025-01374 — Terumo BCT, Inc. v. Haemonetics Corp.

• Type: Inter Partes Review
• Filed: 2025-08-04
• Status: Pending - Instituted. The PTAB panel reviewed the petition and the patent owner's preliminary response and determined the petitioner met the statutory threshold to initiate a trial.
• Judge Panel: I am unable to confirm the specific judges on the panel with the available information. This is public information contained in the institution decision document.
• Petition Grounds: The petition challenges all claims (1-20) of the '124 patent on grounds of obviousness under 35 U.S.C. § 103, based on multiple prior art references.
• Institution Decision: The trial was instituted. A defendant should review the decision (available on the USPTO's PTAB E2E portal) to understand the panel's reasoning and which specific prior art combinations the Board found persuasive.
• Final Written Decision: Not yet issued. The statutory deadline for the PTAB to issue a Final Written Decision (FWD) is one year from the date of institution. A defendant should calculate and track this deadline.
• Settlement / Termination: There is no public record of a settlement. The case is proceeding toward a final decision.
• Appeal: Not applicable. An appeal to the U.S. Court of Appeals for the Federal Circuit can only occur after the FWD is issued.
• Defensive Value: Extremely high. The institution of an IPR on all claims signals a significant vulnerability for the patent owner. Any parallel district court litigation may be stayed pending the outcome of this IPR. The arguments and evidence presented by the petitioner, Terumo BCT, Inc., can provide a detailed roadmap for a defendant's own invalidity contentions.

Strategic Summary

The entirety of US Patent 11,738,124 is currently under a cloud. All 20 claims are UNTESTED in a final merits decision but have survived the initial institution phase, meaning a panel of expert administrative patent judges believes they are reasonably likely to be proven unpatentable.

From an estoppel perspective, 35 U.S.C. § 315(e) is not yet a factor for any party. Estoppel will only attach to the petitioner, Terumo BCT, Inc. (and its real parties-in-interest), after a Final Written Decision is issued. For another defendant, all prior art-based invalidity grounds remain available. However, the most prudent and cost-effective strategy is often to monitor the active IPR, as a finding of unpatentability will benefit all potential defendants. The petitioner appears to be a direct competitor, suggesting this is a well-funded, strategic challenge rather than a nuisance filing. This IPR is part of a larger dispute, including district court litigation in Colorado (Haemonetics Corp. v. Terumo BCT, Inc., Case No. 1:25-cv-01409).

Recommended Next Steps

For any defendant facing an assertion of US Patent 11,738,124, the immediate priority is to closely monitor the active IPR proceeding.

• Obtain Key Documents: Download the Petition, the Patent Owner's Preliminary Response, and the Decision on Institution from the USPTO's PTAB E2E portal for IPR2025-01374. These documents contain the specific invalidity arguments, the patent owner's initial defenses, and the PTAB's reasoning for instituting the trial.
• Track Key Dates: Identify the institution date from the PTAB's decision and calculate the one-year deadline for the Final Written Decision. Also, monitor the docket for deadlines for the Patent Owner Response, the Petitioner's Reply, and the oral hearing date.
• Consider a Litigation Stay: If you are in active litigation, the existence of this instituted IPR provides a strong basis for filing a motion to stay the district court case pending the PTAB's final decision. This can save significant litigation costs and allows the USPTO, the expert agency on patentability, to rule first. A motion to stay has already been filed in the related litigation between Haemonetics and Terumo BCT.
• Leverage in Negotiations: The pending IPR provides powerful leverage in any settlement or licensing discussions. The patent's value is significantly diminished until it survives the final PTAB decision.

The plain fact is that no PTAB activity was found in the initial data ingest, but a critical, instituted IPR is underway. The absence of this information in a given database highlights the need for live, comprehensive searches before making strategic decisions.

Inventors

• Michael Ragusa: The sole inventor listed on the patent. Based on the assignment record (Reel 61077/0173), Mr. Ragusa assigned the patent to Haemonetics Corporation, indicating he was likely an employee or contractor for the company at the time of invention.

Original assignee

The original assignee is Haemonetics Corporation (NYSE: HAE). Haemonetics is a global healthcare company that provides medical products and solutions for hematology, including apheresis systems for plasma and platelet collection, and surgical blood salvage systems. The company actively develops, manufactures, and sells products that appear to embody the claims of US patent 11,738,124, which is directed to a "System and method for collecting plasma." As of May 2026, Haemonetics is an active, publicly-traded operating company.

Assignment timeline

An online search of the USPTO Patent Assignment Search database for US patent 11,738,124 shows the following recorded assignments.

• 2022-09-08 (executed) / recorded 2022-09-13 — Reel 061077/0173
  • Conveyance: Assignment
  • Assignor: Michael Ragusa
  • Assignee: Haemonetics Corporation
  • Correspondent: Matthew F. Lambrinos, Wolf, Greenfield & Sacks, P.C., 600 Atlantic Avenue, Boston, MA 02210
  • Context: Standard assignment of interest from an inventor to their employer.
• 2025-02-11 (executed) / recorded 2025-02-19 — Reel 065163/0746
  • Conveyance: Corrective Assignment
  • Assignor: Michael Ragusa
  • Assignee: Haemonetics Corporation
  • Correspondent: Matthew F. Lambrinos, Wolf, Greenfield & Sacks, P.C., 600 Atlantic Avenue, Boston, MA 02210. The correspondent is the same as in the original assignment.
  • Context: A corrective action to the original assignment, confirming the transfer to the original assignee.

Timeline diagram

timeline
    title Ownership of US 11738124
    2017 : Priority Date
    2022 : Assigned to Haemonetics Corp
    2023 : Patent Issued
    2025 : Corrective assignment filed
         : Litigation initiated

NPE / troll-pattern signals

1. Shell-entity transfer: Not present. The patent was assigned from the inventor directly to Haemonetics Corporation, a publicly-traded medical device company, which remains the current owner.
2. Known asserter in the chain: Not present. Haemonetics Corporation is an operating company, not a known NPE or patent assertion entity.
3. Repeat correspondent across the chain: Not present. The same correspondent, Matthew F. Lambrinos of Wolf, Greenfield & Sacks, P.C., appears on both the initial assignment (Reel 061077/0173) and the corrective assignment (Reel 065163/0746). This is standard practice for a company's outside counsel handling related filings and does not indicate NPE activity.
4. Cascading transfers: Not present. The ownership chain consists of a single inventor-to-company transfer and a subsequent correction.
5. Pre-litigation transfer: Not present. The initial assignment from the inventor to the company was recorded in September 2022, well before the litigation noted in 2025. This transfer establishes the company's standing to sue and is not a transfer to a third-party assertion entity.
6. Bankruptcy fire-sale: Not present. Haemonetics Corporation is a financially solvent, active company.
7. Privateering: Not present. The patent is being asserted by the original assignee, an operating company.
8. Defensive aggregator (anti-NPE): Not present. The patent remains with its original corporate assignee.

Verdict

Operating-company assertion

The patent's ownership has remained with the original assignee, Haemonetics Corporation, a major medical technology company that manufactures and sells products in the field of the invention. The assignment history shows only a standard transfer from the inventor to his employer. The subsequent litigation is an example of an operating company asserting its patents directly, not an action by an NPE.

Verification link: USPTO Assignment Search for US 11738124

Analysis of Prior Art for U.S. Patent 11,738,124

This analysis identifies and evaluates the most relevant prior art cited during the prosecution of U.S. Patent 11,738,124 ("the '124 patent"). The focus is on references that could potentially anticipate the patent's claims under 35 U.S.C. § 102, which pertains to novelty. The '124 patent, assigned to Haemonetics Corporation, claims a system and method for collecting a target volume of "pure plasma" by calculating and subtracting the volume of anticoagulant from the total collected volume, based on the donor's hematocrit.

The following prior art references are deemed most relevant to the core inventive concept of the '124 patent. This is not an exhaustive list of all citations but represents the patents that most closely describe the claimed invention.

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1. U.S. Patent 5,681,273 A (Loken et al.)

• Full Citation: US 5,681,273 A, "Systems and methods for predicting blood processing parameters"
• Assignee: Baxter International Inc.
• Filing Date: December 23, 1991
• Publication Date: October 28, 1997
• Brief Description: This patent describes systems and methods for predicting blood processing parameters for an individual subject before an apheresis procedure begins. It discloses inputting subject-specific data, including hematocrit and weight, into a controller. The system then uses this data to predict outcomes like the time required to collect a desired quantity of a blood component (e.g., plasma) and the total volume of anticoagulant that will be required. The goal is to optimize the procedure for the specific donor.
• Potential Anticipation of Claims:
  • Claim 1 (Method): The '273 patent discloses many elements of claim 1, including determining a donor's weight and hematocrit (claim 1a, 1b), withdrawing blood (1d), introducing anticoagulant (1e), and separating blood components (1f). However, Loken's system is primarily for predicting parameters before the procedure, rather than actively calculating the volume of "pure plasma" during the procedure and stopping based on that real-time calculation. While it uses hematocrit to calculate the total required anticoagulant, it does not explicitly teach the step of calculating the volume of anticoagulant in the collected plasma component and then calculating the volume of pure plasma to control the collection process in real-time as recited in claims 1(h) and 1(i).
  • Claim 11 (System): Similarly, the '273 patent discloses a system with a controller that uses hematocrit and weight data. However, the controller is configured to predict outcomes, not necessarily to perform the specific real-time calculation of pure plasma volume and stop the blood draw pump based on reaching a "target volume of pure plasma" as recited in claim 11. The inventive step of the '124 patent appears to be the real-time calculation and control based on pure plasma volume, which is not explicitly detailed in the '273 patent.

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2. U.S. Patent 4,086,924 A (Latham, Jr.)

• Full Citation: US 4,086,924 A, "Plasmapheresis apparatus"
• Assignee: Haemonetics Corporation
• Filing Date: October 6, 1976
• Publication Date: May 2, 1978
• Brief Description: This is a foundational patent for Haemonetics' plasmapheresis technology. It describes an apparatus for separating blood into components, specifically for collecting plasma and returning red blood cells to the donor. The system includes a centrifuge bowl, pumps for whole blood and anticoagulant, and controls for managing the process. The process involves cycles of drawing and returning blood components.
• Potential Anticipation of Claims:
  • Claim 1 (Method) & Claim 11 (System): The '924 patent discloses the fundamental components and steps of a plasmapheresis system: a venous-access device, drawing blood, introducing anticoagulant, separating components in a centrifuge, collecting plasma, and returning other components (Claims 1c-g, 1j). It provides the basic hardware foundation described in claim 11. However, the '924 patent does not teach or suggest using the donor's hematocrit to calculate the volume of anticoagulant in the collected product or to determine a "pure plasma" volume as the endpoint for collection. The control system described is focused on managing the draw/return cycles and detecting interfaces between blood components (e.g., using optical sensors), not on standardizing the collected product volume by accounting for anticoagulant.

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3. U.S. Patent 5,494,592 A (Latham, Jr. et al.)

• Full Citation: US 5,494,592 A, "Apheresis apparatus and method"
• Assignee: Haemonetics Corporation
• Filing Date: April 27, 1993
• Publication Date: February 27, 1996
• Brief Description: This patent describes an apheresis system with an improved control method that allows for the collection of multiple blood products (e.g., plasma and platelets) concurrently or sequentially. It details a system that monitors the volume of collected components, for example, by weighing the collection bags. The controller adjusts the process based on these collected volumes and can switch between collection modes.
• Potential Anticipation of Claims:
  • Claim 1 (Method): The '592 patent discloses monitoring the volume/weight of the collected plasma component (relevant to dependent claims 5 and 6 of the '124 patent). It teaches a sophisticated control system that stops collection based on achieving a target volume. However, this target volume is for the total collected fluid (plasma plus anticoagulant). The patent does not disclose the crucial steps of using the donor's hematocrit to calculate the percentage of anticoagulant in the collected plasma and then calculating the "pure plasma" volume to use as the collection target (claims 1h, 1i).
  • Claim 11 (System): This patent describes a system with a controller and weight sensors that is functionally very similar to the system in claim 11. The key difference remains in the programming of the controller. The '592 patent's controller stops collection based on the weight of the anticoagulated plasma, whereas the '124 patent's controller is specifically configured to perform the "pure plasma" calculation based on hematocrit and stop based on that calculated value.

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Summary of Analysis

The key innovation claimed in U.S. Patent 11,738,124 is not the physical apparatus for plasmapheresis, which is well-established in the prior art cited. Instead, the inventive concept lies in the specific method of process control: the real-time calculation of "pure plasma" volume by accounting for the volume of anticoagulant (which varies based on donor hematocrit) and using this calculated "pure plasma" volume as the definitive endpoint for the collection procedure.

While the cited prior art, particularly US 5,681,273, discloses using donor-specific information like hematocrit to plan and optimize a procedure, it does not appear to describe the specific, dynamic calculation and control loop claimed in the '124 patent. Other references like US 4,086,924 and US 5,494,592 describe the necessary hardware and basic control of stopping collection based on a target volume, but this target is for the total mixture of plasma and anticoagulant, not for a standardized volume of pure plasma.

Therefore, under a 35 U.S.C. § 102 analysis, none of these single references appear to explicitly disclose all limitations of independent claims 1 and 11, particularly the calculation of pure plasma volume based on hematocrit and using that calculated value to terminate the collection. An argument for obviousness under 35 U.S.C. § 103, combining the teachings of these references, would be the more likely avenue for a validity challenge, as is being pursued in the instituted IPR (IPR2025-01374).

Obviousness Analysis of U.S. Patent 11,738,124

Date of Analysis: May 13, 2026

Standard: An invention is unpatentable if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art (PHOSITA). This analysis is based on prior art available before the patent's priority date of May 30, 2017.

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Analysis of Independent Claim 1 (Method) and Claim 11 (System)

The independent claims of U.S. Patent 11,738,124 are directed to a method and system for plasma collection where the key inventive concept is the calculation of the "pure plasma" volume collected by accounting for the volume of anticoagulant mixed in with the plasma, using the donor's hematocrit in the calculation, and stopping the procedure when a target volume of this pure plasma is reached.

The claims would have been obvious to a Person Having Ordinary Skill in the Art (PHOSITA) by combining the teachings of a standard automated apheresis system with the well-established and widely published clinical knowledge regarding plasma volume calculations.

1. The Prior Art Baseline: Standard Apheresis Systems and Clinical Knowledge

• Basic Apheresis Systems: Prior to 2017, numerous patents, including many cited by the '124 patent itself (e.g., U.S. 4,086,924 to Latham, Jr. or U.S. 4,151,844 to Cullis, et al.), disclosed the fundamental components of an automated apheresis system. This established art included a venous-access device, pumps, a blood component separator (like a centrifuge), tubing, collection containers, and a controller to automate the process of drawing blood, separating components, collecting a desired component, and returning the remainder. These systems commonly used weight scales to monitor the volume of the collected product and stop the procedure when a target weight/volume was reached.

• Established Clinical Knowledge: It was common knowledge in the medical and apheresis fields that a donor's hematocrit (Hct) is the primary determinant of their plasma-to-red-cell ratio. Clinical guidelines and scientific publications available well before 2017 taught the explicit use of this information.

  • A 2014 article in the Journal of Clinical Apheresis titled "Calculations in apheresis" explicitly states, "By knowing the TBV [Total Blood Volume] and the Hct, the TPV [Total Plasma Volume] of the patient can be calculated." The article further explains how a donor's hematocrit directly influences the plasma collection procedure and the time required.
  • Standard medical procedure, as described in a Medscape article on plasmapheresis technique, involves entering the donor's height and weight into the system to estimate Total Blood Volume, and then calculating the plasma volume using the formula: Plasma Volume = TBV × (1 – hematocrit). This demonstrates that using donor weight and hematocrit to determine a target plasma volume was a routine and known practice.
  • Furthermore, the concept of accounting for the anticoagulant volume was also known. A presentation titled "Math in Donor Apheresis" notes that European collection guidelines specify that the maximum collected volume (e.g., 750 mL) is measured "exclusive of anti-coagulant." This teaching explicitly recognizes the distinction between the total volume in the collection bag and the "pure" plasma volume, and its importance for regulatory compliance and donor safety.

2. Motivation to Combine

A PHOSITA, such as a biomedical engineer designing apheresis equipment, would have been motivated to combine the known hardware of an automated apheresis system with the established clinical calculations for several reasons:

• To Solve a Known Problem: The '124 patent itself identifies the problem that collecting a fixed total volume results in inconsistent plasma yields from donors with different hematocrits. This was a known issue in the art. The 2014 "Calculations in apheresis" article details how hematocrit impacts collection, meaning a PHOSITA would have been aware of this inefficiency. Automating the known manual calculations directly addresses this known problem.
• Predictability of Results: A PHOSITA would have understood that programming a controller to perform the simple, algebraic calculations already being done manually or on external calculators would predictably result in a more standardized and accurate collection of pure plasma. The formula to calculate pure plasma is a straightforward subtraction: (Pure Plasma) = (Total Collected Volume) - (Anticoagulant Volume). The relationship between anticoagulant volume, whole blood processed, and the plasma fraction (1-Hct) was well understood. Implementing this logic in the system's controller would have been a routine design choice to achieve a more precise outcome.
• Automation of a Manual Process: It is a common and obvious path in engineering to automate routine, calculation-based tasks to improve consistency, reduce human error, and enhance efficiency. Since operators were already aware of and using the relationship between hematocrit and plasma volume to guide procedures, programming the system's controller to perform these same calculations is a classic example of applying automation to a known process.

3. Rendering the Claims Obvious

• Claim 1 (Method): All steps of the method claim were either part of standard apheresis or were well-known calculations in the art. A standard apheresis procedure already involved steps (a) through (g). The novel steps are (h) calculating the anticoagulant volume based on hematocrit, (i) calculating the pure plasma volume, and (j) continuing until a target pure plasma volume is reached. As established, the formulas and the scientific basis for these calculations were common knowledge. It would have been obvious to apply these known formulas to the data already available in an apheresis procedure (donor weight, hematocrit, anticoagulant ratio, and total collected volume) to achieve the more precise endpoint of a pure plasma target.

• Claim 11 (System): The system claim recites standard hardware components. The novelty lies in the configuration of the controller. As argued above, configuring a controller to perform the well-known plasma volume calculations and use the result as a stop condition for the blood pump is an obvious implementation. The controller is the logical component to house this calculation, and programming it to do so would have been a routine task for a PHOSITA aiming to improve the precision of the existing system based on known principles.

Conclusion

The claims of U.S. Patent 11,738,124 would have been obvious over the combination of a standard automated apheresis system and the well-established knowledge in the art concerning the calculation of plasma volume from a donor's weight and hematocrit. The motivation to combine these elements was strong and clear: to solve the known problem of inconsistent plasma yields and to automate a routine clinical calculation to improve the efficiency, accuracy, and standardization of the plasmapheresis process. The solution claimed represents the application of known principles to a known system to achieve predictable results.

Patent Term and Application History for U.S. Patent 11,738,124

Date of Analysis: May 13, 2026

This analysis details the patent term, application history, and related patent family for U.S. Patent 11,738,124.

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Patent Term Adjustments (PTA) and Extensions (PTE)

• Patent Term Adjustment (PTA): There are no Patent Term Adjustments indicated for U.S. Patent 11,738,124. The patent's term is calculated directly from its earliest effective filing date.
• Patent Term Extension (PTE): There is no evidence of a Patent Term Extension under 35 U.S.C. § 156, which typically compensates for delays in regulatory review (e.g., by the FDA).

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Application and Examination History

U.S. Patent 11,738,124 resulted from U.S. Application No. 17/943,410, which was filed on September 13, 2022. However, this application is part of a series of continuing applications that claim priority to an earlier patent. The lineage is as follows:

• U.S. Patent 11,738,124 (the patent in question) issued from Application No. 17/943,410, filed September 13, 2022.
  • This is a continuation of Application No. 17/205,374, filed March 18, 2021 (now U.S. Patent No. 12,171,916).
    • This, in turn, is a continuation of Application No. 16/866,078, filed May 4, 2020 (now U.S. Patent No. 10,980,926).
      • This, in turn, is a continuation of the original parent application, Application No. 15/608,183, filed May 30, 2017 (now U.S. Patent No. 10,758,652).

This chain of continuation applications establishes the earliest effective filing date for calculating the patent term as May 30, 2017. No divisional applications were identified in the patent's prosecution history.

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Patent Family Members

U.S. Patent 11,738,124 is part of a large international patent family, with applications filed in numerous jurisdictions claiming priority to the original 2017 U.S. application. Notable granted patents in this family include:

• United States:
  • US 10,758,652 B2
  • US 10,980,926 B2
  • US 12,171,916 B2
• Japan: JP 7257336 B2
• China: CN 110799223 B
• South Korea: KR 102585128 B1
• Australia: AU 2018275198 C1
• International Publication: WO 2018/222441 A1

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Projected Expiration Date

The term of a U.S. patent is 20 years from the filing date of the earliest U.S. or international (PCT) application to which priority is claimed. Based on the earliest priority date of May 30, 2017, the projected expiration date for U.S. Patent 11,738,124 is May 30, 2037.

This expiration is contingent upon:

1. The timely payment of all required maintenance fees to the USPTO.
2. The outcome of the pending Inter Partes Review (IPR2025-01374), which could result in the invalidation of some or all claims before the patent reaches its full term.

This Defensive Disclosure document provides a series of technical descriptions for derivative inventions and improvements based on the core concepts disclosed in U.S. Patent 11,738,124. The purpose of this document is to place these concepts into the public domain, thereby establishing them as prior art for patentability purposes.

Disclosure 1: Material & Component Substitution

Derivative 1.1: Piezoresistive Microfluidic Anticoagulant Dosing System

• Enabling Description: This variation replaces the peristaltic anticoagulant pump (e.g., 234 in patent FIG. 3) with a solid-state microfluidic pump based on piezoresistive displacement. The pump consists of a silicon-on-glass substrate with a micro-etched channel and a chamber actuated by a PZT (lead zirconate titanate) ceramic element. A closed-loop control system uses a micro-flow sensor downstream of the pump to provide feedback to the controller. The controller adjusts the voltage and frequency applied to the PZT element to achieve a precise, non-pulsatile anticoagulant flow rate in the range of 0.1 to 15 mL/min with a resolution of 10 microliters. This substitution eliminates the mechanical wear and potential for spallation associated with peristaltic tubing and allows for a more accurate, real-time calculation of the infused anticoagulant volume, thereby improving the accuracy of the final pure plasma calculation.

• Diagram:

  graph TD
      subgraph Controller [Controller Unit]
          A[CPU] -- PZT Drive Signal --> B(PZT Actuator Driver);
          C(Micro-flow Sensor Interface) -- Flow Data --> A;
      end
      subgraph Microfluidic Pump
          D[Anticoagulant Reservoir] --> E{PZT-actuated Pump Chamber};
          E --> F[Micro-flow Sensor];
      end
      B --> E;
      F --> G((To Blood Draw Line));
      F -- Analog Signal --> C;
  

Derivative 1.2: Raman Spectroscopy for In-Line Hematocrit and Anticoagulant Sensing

• Enabling Description: This derivative replaces the separate hematocrit determination step and the reliance on pump rotation counting with a single, in-line Raman spectroscopy sensor. The sensor is positioned on the whole blood draw line, prior to the separation device. A 785 nm laser is focused through a sapphire window into the fluid path. The backscattered Raman-shifted photons are collected and analyzed by a spectrometer. The controller uses a chemometric model, pre-trained on samples with known hematocrit and anticoagulant (e.g., sodium citrate) concentrations, to simultaneously resolve the Raman peaks corresponding to hemoglobin (for hematocrit) and citrate ions. This provides a direct, real-time measurement of both donor hematocrit and the actual anticoagulant concentration in the anticoagulated whole blood, accounting for any pump inaccuracies or priming residues. This data feeds directly into the pure plasma calculation algorithm.

• Diagram:

  sequenceDiagram
      participant Donor
      participant RamanSensor as Raman Sensor
      participant Controller
      participant BloodSeparator as Separation Device
  
      Donor->>+RamanSensor: Whole Blood Flows
      RamanSensor->>RamanSensor: Excite with 785nm Laser
      RamanSensor->>Controller: Transmit Raman Spectrum
      Controller->>Controller: Apply Chemometric Model (Hct, [AC])
      Controller->>RamanSensor: Acknowledge
      RamanSensor-->>-BloodSeparator: Anticoagulated Blood Continues
      Controller->>BloodSeparator: Adjust Separation Parameters
  

Derivative 1.3: Tangential Flow Filtration with Graphene-Oxide Composite Membrane

• Enabling Description: The centrifugal blood component separation device is replaced with a tangential flow filtration (TFF) module. The core of this module is a hollow-fiber membrane cartridge composed of a polysulfone substrate with a functionalized surface layer of graphene-oxide (GO). The GO layer is engineered with a nominal pore size of 0.2 microns and a highly negative surface charge to repel cellular components (erythrocytes, leukocytes) while allowing plasma proteins to pass through. The system controller actively manages transmembrane pressure (TMP) and cross-flow velocity to minimize hemolysis and membrane fouling. The "pure plasma" calculation from the patent's core claim is used here to control the TFF process, terminating the collection once the target volume of cell-free, pure plasma (calculated by subtracting the measured anticoagulant volume from the total permeate volume) is achieved.

• Diagram:

  graph TD
      WB[Anticoagulated Whole Blood] --> P1(Pump);
      P1 --> TFF{TFF GO-Membrane Module};
      TFF -- Retentate (RBCs, etc.) --> R((To Donor/Waste));
      TFF -- Permeate (Plasma + AC) --> S[Permeate Weight Sensor];
      S --> C{Collection Bag};
      S -- Weight Data --> CTRL(Controller);
      CTRL -- Pump Control --> P1;
      CTRL --> R;
      subgraph Real-time Calculation
          CTRL -- "Pure Plasma Vol = Total Vol - AC Vol" --> Stop(Stop Collection?);
      end
  

Disclosure 2: Operational Parameter Expansion

Derivative 2.1: Nanoscale Apheresis for Exosome Isolation from Liquid Biopsy

• Enabling Description: The method is scaled down to a microfluidic lab-on-a-chip for isolating exosomes from microliter volumes of plasma for diagnostic purposes. A 100 µL plasma sample (already separated from whole blood) is introduced into the chip and mixed with an exosome precipitation agent (e.g., polyethylene glycol), which acts as the "anticoagulant" analog. The mixture flows into a separation chamber where acoustophoresis, using MHz-frequency standing surface acoustic waves, separates the precipitated exosomes from the bulk plasma. An in-line optical density sensor measures the concentration of the precipitation agent. The controller calculates the volume of "pure" exosome-free supernatant and routes the exosome concentrate to a collection well once a target supernatant removal volume is reached, ensuring a standardized exosome concentration for downstream analysis.

• Diagram:

  stateDiagram-v2
      [*] --> Priming
      Priming --> Sample_Injection: Chip Primed
      Sample_Injection --> Mixing: 100uL Plasma Injected
      Mixing: Mix with PEG
      Mixing --> Separation: Mixture Flows to Chamber
      Separation: Apply Acoustic Field
      Separation --> Sensing: Supernatant Flows Past Sensor
      Sensing --> Calculation: Measure PEG Concentration
      Calculation --> Decision
      Decision: Pure Supernatant Target Reached?
      Decision -- No --> Separation: Recirculate/Continue
      Decision -- Yes --> Collection
      Collection --> [*]
  

Derivative 2.2: Industrial Scale Bioreactor Harvest with Target Protein Calculation

• Enabling Description: The disclosed method is applied to a 2000-liter mammalian cell culture bioreactor for harvesting monoclonal antibodies (mAbs). A harvesting agent (e.g., a clarifying flocculant) is added to the bioreactor. The cell culture fluid is then passed through a depth filtration system. A downstream sensor (e.g., a turbidity or capacitance sensor) measures the concentration of the residual flocculant. The system controller calculates the volume of "pure" mAb-containing supernatant by subtracting the calculated flocculant volume from the total harvested volume. The harvest is automatically terminated when a pre-set target volume of pure supernatant is collected, ensuring consistent batch-to-batch dilution and optimizing downstream purification steps.

• Diagram:

  graph LR
      A[Bioreactor (2000L)] -- Add Flocculant --> B(Pump);
      B --> C{Depth Filtration Skid};
      C -- Cell Debris --> Waste;
      C -- Supernatant --> D[Flocculant Sensor];
      D --> E[Collection Tank];
      D -- Concentration Data --> F(Process Controller);
      F -- "Calculate Pure Supernatant Volume" --> F;
      F -- "IF Target Reached THEN Stop" --> B;
  

Disclosure 3: Cross-Domain Application

Derivative 3.1 (Aerospace): On-Orbit Water Purification Control

• Enabling Description: This system is adapted for a closed-loop water recycling system aboard a long-duration spacecraft. Wastewater is treated with a known concentration of an iodinated resin disinfectant, which acts as the "anticoagulant" analog. The water is then passed through a filtration and purification unit. A downstream ion-selective electrode (ISE) sensor measures the residual iodine concentration. The control system calculates the volume of "pure" potable water by subtracting the volume attributed to the disinfectant from the total processed volume. The system terminates the purification cycle for a given batch once a target volume of pure water is confirmed, ensuring compliance with purity standards for crew consumption.

• Diagram:

  flowchart TD
      A[Wastewater Tank] --> B{Dosing Unit};
      C[Iodine Resin] --> B;
      B --> D(Pump);
      D --> E[Purification Unit];
      E -- Brine/Waste --> F;
      E -- Processed Water --> G{Iodine ISE Sensor};
      G --> H[Potable Water Tank];
      G -- Iodine Conc. --> I(System Controller);
      I -- "Pure H2O Vol = Total Vol - Iodine Vol" --> J{Stop Cycle?};
      J -- Yes --> D;
  

Derivative 3.2 (AgTech): Automated Saffron Extraction Yield Optimization

• Enabling Description: The system is applied to the solvent-based extraction of crocin and safranal from saffron. Dried saffron stigmas are mixed with a specific volume of an ethanol-water solvent (the "anticoagulant" analog) in an extraction vessel. The mixture is then separated via filtration. A spectrophotometer in the filtrate line continuously measures the absorbance at specific wavelengths (e.g., 440 nm for crocin) and also the baseline shift caused by the solvent itself. The controller uses this data to calculate the real-time concentration and thus the total extracted mass of "pure" crocin, distinct from the solvent mass. The extraction process is dynamically controlled and stopped when the rate of increase of pure crocin yield falls below a threshold, optimizing vessel time and energy consumption.

• Diagram:

  sequenceDiagram
      participant Vessel as Extraction Vessel
      participant Spectro as Spectrophotometer
      participant Controller
      Vessel->>Vessel: Add Saffron & Solvent
      loop Extraction Process
          Vessel->>Spectro: Circulate Extract
          Spectro->>Controller: Transmit Absorbance Spectrum
          Controller->>Controller: Calculate Pure Crocin Yield
          Controller->>Controller: Analyze Yield Rate (dYield/dt)
          alt Rate > Threshold
              Controller-->>Vessel: Continue Extraction
          else Rate <= Threshold
              Controller-->>Vessel: Stop Extraction
              break
          end
      end
  

Disclosure 4: Integration with Emerging Technologies

Derivative 4.1 (AI Integration): Predictive AI for Donor-Specific Procedure Optimization

• Enabling Description: The system controller is augmented with a pre-trained Recurrent Neural Network (RNN) model. During the procedure, the model receives real-time inputs from IoT-enabled sensors: the Raman sensor (hematocrit), anticoagulant flow meter, blood pump pressure sensors, and a non-invasive cuff measuring the donor's heart rate and blood pressure. The RNN model predicts in real-time the donor's vascular response and potential for citrate reaction. It dynamically adjusts the blood draw rate and the anticoagulant-to-blood ratio to maximize the collection efficiency of pure plasma while keeping the donor's physiological parameters within a personalized safety envelope. The target pure plasma volume may be slightly adjusted downwards by the AI if it predicts an impending adverse reaction.

• Diagram:

  graph TD
      subgraph Inputs
          A[Donor Vitals (HR, BP)];
          B[Hematocrit Sensor];
          C[Pressure Sensor];
          D[AC Flow Rate];
      end
      subgraph Controller
          E(RNN Model);
          F[Control Logic];
      end
      subgraph Outputs
          G[Blood Pump Speed];
          H[AC Pump Speed];
          I[Adjusted Target Volume];
      end
      A & B & C & D --> E;
      E -- Predictions --> F;
      F --> G & H & I;
  

Derivative 4.3 (Blockchain Verification): Immutable Ledger for Plasma Provenance

• Enabling Description: Upon completion of a donation, the apheresis machine's controller generates a data block containing the final calculated pure plasma volume, the donor's anonymized cryptographic ID, the timestamp, the machine's unique identifier, the disposable kit's unique ID (read from an RFID tag), and a hash of the full procedure log. This data block is signed with the machine's private key and submitted as a transaction to a permissioned Hyperledger Fabric blockchain shared between collection centers, testing labs, and fractionation facilities. This creates an auditable, immutable record for each unit of plasma, ensuring full traceability and verifying that the collected volume corresponds to the "pure plasma" standard, not the total fluid volume.

• Diagram:

  erDiagram
      DONOR {
          string anonymousDonorID PK
      }
      PLASMA_UNIT {
          string unitID PK
          string anonymousDonorID FK
          string machineID FK
          float purePlasmaVolume
          datetime timestamp
          string transactionHash
      }
      MACHINE {
          string machineID PK
          string location
      }
      PLASMA_UNIT ||--o{ DONOR : collectedFrom
      PLASMA_UNIT ||--o{ MACHINE : collectedOn
  

Disclosure 5: The "Inverse" or Failure Mode

Derivative 5.1: Graceful Degradation to Volumetric Limiting on Sensor Failure

• Enabling Description: The system is designed with a safe-fail mode for the primary hematocrit sensor (e.g., Raman sensor or optical sensor). The controller continuously performs a self-check on the sensor's signal, looking for values outside an expected physiological range or a lack of signal variance. If a sensor failure is detected, the controller triggers three actions: 1) It immediately flags an alert to the operator's user interface. 2) It transitions its control algorithm from "pure plasma target" to a conservative "total volume target". This new target is calculated as the lesser of either the FDA-allowed total volume (e.g., 880 mL) or 110% of the originally intended pure plasma target (e.g., 110% of 800 mL = 880 mL). 3) It logs the failure event and the exact time of the control mode switch. This ensures the procedure can be completed safely without risking over-collection, prioritizing donor safety over yield optimization when critical data is unavailable.

• Diagram:

  stateDiagram-v2
      state "Normal Operation (Pure Plasma Target)" as Normal {
          [*] --> Running
          Running: HCT_Sensor_OK
          Running --> Sensor_Fail_Detected : event SensorFailure
      }
      state "Degraded Mode (Total Volume Target)" as Degraded {
          Entry: Alert Operator
          Entry: Set Conservative Target
          [*] --> Running
          Running: Collect based on total volume
          Running --> Procedure_Complete
      }
      Normal --> Degraded : HCT_Sensor_Fail
      Degraded --> [*]
  

Combination Prior Art Scenarios

1. AI On-Device with TensorFlow Lite: The predictive AI model for donor-specific optimization (Derivative 4.1) is compiled using the TensorFlow Lite open-source machine learning framework. The resulting model is deployed directly onto the apheresis machine's embedded ARM-based controller. This enables real-time, low-latency inference for pump and ratio adjustments without requiring a constant cloud connection, making the advanced optimization feature robust and self-contained.

2. IoT Data Streaming with MQTT: The IoT sensors monitoring the apheresis procedure (Derivative 4.2) are configured to publish their data (pressure, temperature, flow rates, status) to a central broker using the MQTT (Message Queuing Telemetry Transport) protocol, an ISO standard (ISO/IEC 20922). This lightweight pub/sub protocol ensures reliable data delivery over potentially unreliable networks (like Wi-Fi in a busy clinic), allowing a remote fleet management dashboard to monitor thousands of devices efficiently.

3. Blockchain Provenance with Hyperledger Fabric: The system for creating an immutable ledger of plasma provenance (Derivative 4.3) is implemented using the open-source Hyperledger Fabric framework. A "chaincode" (smart contract) is written to define the transaction structure (donor ID, pure plasma volume, machine ID, etc.) and the business logic for validating and committing new entries to the blockchain. This leverages a widely adopted, enterprise-grade open-source standard for building the distributed ledger, ensuring interoperability and security.