US 10792416

Patent Summary: US 10,792,416 B2

Title: System and method for collecting plasma

Assignee: Haemonetics Corp

Inventor: Michael Ragusa

Filing Date: October 25, 2017

Issue Date: October 6, 2020

Abstract:
A method for collecting plasma includes determining the weight, height, and hematocrit of a donor, and calculating a donor plasma volume and a target plasma collection volume. The target plasma collection volume is based on the donor plasma volume and a target percentage of plasma. The method then withdraws blood from the donor through a line connected to a blood component separation device, and introduces anticoagulant into the withdrawn blood.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 the volume of pure plasma collected within the plasma collection container, and continue processing/collecting until the calculated volume of pure plasma equals the target plasma collection volume.

---

Plain-Language Overview of Independent Claims:

This patent has three independent claims: Claim 1 (a method), Claim 11 (a system), and Claim 18 (a method).

Claim 1 (Method for Collecting Plasma):
This claim describes a process for collecting plasma from a donor that is personalized to that individual. The core steps are:

1. Determine Donor Information: The process starts by measuring the donor's weight and hematocrit (the proportion of red blood cells in their blood).
2. Venous Access: A needle or similar device is inserted into the donor's vein.
3. Blood Withdrawal and Separation: Whole blood is drawn from the donor, mixed with an anticoagulant to prevent clotting, and then separated into plasma and other blood components (like red blood cells) using a separation device.
4. Plasma Collection: The separated plasma component is collected into a container.
5. Calculate "Pure" Plasma Volume: Crucially, the system calculates the actual volume of plasma collected, excluding the volume of the anticoagulant that was mixed in. This is done by first calculating the percentage of anticoagulant in the collected fluid.
6. Stop at Target: The collection process continues until a predetermined target volume of pure plasma is reached. This target is based on the donor's weight.

In essence, this method aims to collect a more accurate and standardized amount of plasma from each donor by accounting for the variable amount of anticoagulant in the final collected product.

Claim 11 (System for Collecting Plasma):
This claim describes the physical equipment or "system" that performs the method of Claim 1. The key components of the system are:

1. Blood Access and Separation Devices: A venous-access device (like a needle) and a blood component separation device (like a centrifuge).
2. Tubing and Pumps: A blood draw line to transport blood to the separator and an anticoagulant line to add anticoagulant. A pump controls the flow of blood.
3. A "Smart" Controller: A controller (a computer) is the brain of the system. It is programmed to:
   • Calculate the percentage of anticoagulant in the plasma being collected.
   • Based on that percentage, calculate the volume of pure plasma that has been collected.
   • Stop the blood draw pump automatically when the calculated pure plasma volume reaches a specific target volume, which is determined by the donor's weight.

This system automates the process of collecting a precise, weight-based target volume of pure plasma, removing the guesswork associated with the added anticoagulant.

Claim 18 (A More Personalized Method for Collecting Plasma):
This claim describes a more advanced and personalized method for plasma collection. The key steps are:

1. Gather More Donor Data: This method starts by determining the donor's weight, height, and hematocrit.
2. Calculate Total Plasma Volume: The system uses this data to calculate the donor's total plasma volume in their body.
3. Set a Personalized Target: A target collection volume is then calculated, not just based on weight, but as a specific percentage (e.g., between 26.5% and 29.5%) of the donor's total calculated plasma volume.
4. Collect and Calculate: Blood is withdrawn, mixed with anticoagulant, and separated. The plasma component is collected.
5. Monitor "Pure" Plasma: The system calculates the volume of pure plasma collected, excluding the anticoagulant.
6. Stop When Personalized Target is Met: The process continues until the volume of pure plasma collected equals the personalized target volume.
7. Manage Fluid Balance: After collection, the system may return the other blood components (like red blood cells) and a specific volume of saline to the donor to manage their fluid levels (intravascular deficit) and reduce the risk of adverse reactions like fainting.

This method represents a highly individualized approach, aiming to collect a consistent percentage of each donor's available plasma and actively managing the donor's physiological state post-donation.

---

Disclaimer: This summary is based on the provided patent text. I have not conducted a separate search of CAFC dockets for 2026, and the provided search results did not contain this information. An Inter Partes Review (IPR2025-01420) has been filed against this patent, indicating a challenge to its validity, but the outcome is not specified in the provided information.

As a patent attorney, I can report the following known litigation involving U.S. Patent No. 10,792,416 based on my review of available information as of April 26, 2026.

District Court Litigation

1. Haemonetics Corp. v. Terumo BCT, Inc.

• Plaintiff: Haemonetics Corporation
• Defendant: Terumo BCT, Inc.
• Jurisdiction: U.S. District Court for the District of Colorado
• Case Number: 1:25-cv-01409-RMR-SBP
• Filing Date: May 5, 2025
• Outcome or Current Status: The case is currently active. A scheduling order was issued on August 19, 2025. In this action, Haemonetics alleges that Terumo BCT's Rika Plasma Donation System™ infringes on nine of its patents, including the '416 patent. Haemonetics is seeking damages, including a reasonable royalty and lost profits, as well as treble damages for alleged willful infringement.

2. Haemonetics Corp. v. Fresenius Kabi USA, LLC, et al.

• Plaintiff: Haemonetics Corporation
• Defendants: Fresenius Kabi USA, LLC, Fenwal Inc., and Fresenius Kabi AG
• Jurisdiction: U.S. District Court for the Northern District of Illinois
• Case Number: 1:25-cv-08680
• Filing Date: July 25, 2025
• Outcome or Current Status: This case is active, with an answer and counterclaims filed as of January 2026. While not all initial filings explicitly list every patent-in-suit, related patent office proceedings indicate that this case is connected to the litigation involving the '416 patent family. Haemonetics alleges that the defendants' Aurora Xi Plasmapheresis System infringes on its patents related to optimized plasma collection.

Patent Trial and Appeal Board (PTAB) Proceedings

In addition to the district court cases, U.S. Patent No. 10,792,416 has been the subject of a challenge at the U.S. Patent and Trademark Office's Patent Trial and Appeal Board.

• Terumo BCT, Inc. v. Haemonetics Corp.
  • Proceeding Type: Inter Partes Review (IPR)
  • Case Number: IPR2025-01420
  • Filing Date: October 9, 2025
  • Outcome or Current Status: This proceeding challenges the validity of U.S. Patent No. 10,792,416. The outcome of this IPR could impact the co-pending district court litigation.

Proceedings overview

One AIA trial proceeding has been filed against US patent 10,792,416. That proceeding, an inter partes review (IPR), was denied institution on procedural grounds, meaning the Patent Trial and Appeal Board (PTAB) never reached the substantive merits of the validity challenge. For a potential defendant, this means the patent remains entirely untested at the PTAB, and all prior art grounds are still available for a future challenge.

IPR2025-01420 — Terumo BCT Inc. v. Haemonetics Corp.

• Type: Inter Partes Review
• Filed: 2025-10-09.
• Status: Not Instituted - Procedural. This means the Board declined to start a trial for reasons unrelated to the strength of the invalidity arguments presented in the petition.
• Judge panel: As the case was denied institution without a formal decision on the record explaining the procedural issue, the panel is not publicly documented in standard databases.
• Petition grounds: The specific claims and prior art are not available, as the petition was procedurally denied before these details were entered into the public record in a substantive way.
• Institution decision: The trial was not instituted. Public records indicate the reason was procedural. This can occur for various reasons, such as failure to pay fees, failure to identify all real parties-in-interest, or other formal defects in the petition. The Board did not issue a ruling on the merits of the petitioner's invalidity case.
• Final Written Decision: None; the trial was not instituted.
• Settlement / termination: There was no settlement noted, as the proceeding was terminated at the institution phase.
• Appeal: A decision to deny institution of an IPR cannot be appealed to the Federal Circuit.
• Defensive value: This proceeding offers minimal defensive value. Because the denial was procedural, it provides no insight into the strength of the patent or how the PTAB might view a properly filed future challenge. The prior art raised in the petition (if it can be identified) is not subject to estoppel for the petitioner or any other party.

Strategic summary

Claim Status: All claims of US patent 10,792,416 are UNTESTED before the PTAB. No claims have been canceled or sustained through an AIA trial. The patent's presumption of validity is legally unaffected by the single, procedurally deficient IPR filing.

Estoppel Landscape: 35 U.S.C. § 315(e) estoppel, which prevents a petitioner from re-litigating grounds that were raised or reasonably could have been raised, does not attach when IPR institution is denied. Because IPR2025-01420 was denied on procedural grounds without a final written decision, neither the petitioner (Terumo BCT Inc.) nor any other party is estopped from filing a new IPR on the same or different prior art grounds. A future defendant has a clean slate for mounting a PTAB challenge.

Pattern Signals: The petitioner, Terumo BCT Inc., appears to be a direct competitor of the patent owner, Haemonetics Corp., and has filed multiple AIA petitions against other patents in the same family. This indicates an ongoing, multi-front dispute between the parties, likely tied to co-pending district court litigation. The fact that the initial challenge on this patent failed on procedural grounds suggests a possible error in filing by the petitioner, rather than a lack of potentially invalidating prior art.

Recommended next steps

For a defendant facing an assertion of US patent 10,792,416, the key takeaway is that the patent's validity has not been substantively challenged at the PTAB. The single filed IPR was dismissed for procedural reasons, meaning it has no bearing on the patent's strength.

• No Claims Invalidated: Be aware that the patent holder can truthfully state that the patent has survived a PTAB challenge, but it is crucial to understand that this "survival" was not based on the merits of the patent's claims. No claims are canceled.
• Future IPR is an Option: All options for filing a new IPR remain open. A defendant should conduct a thorough prior art search to assess the viability of a new PTAB challenge, as the grounds presented in the procedurally defective IPR2025-01420 are not known and, in any event, are not precluded from being used again.
• Absence of Merits Review: The current status is a signal of untested validity. Well-asserted patents held by competitors often face multiple, substantive IPR challenges. The lack of a merits-based decision here means a potential defendant must conduct its own invalidity analysis from scratch without guidance from prior PTAB rulings on this patent.

Inventors

• Michael Ragusa: The sole inventor listed on US patent 10,792,416. At the time of filing, the assignment record indicates the patent was assigned to Haemonetics Corporation, suggesting Mr. Ragusa was an employee or contractor for the company. There are no unusual patterns, such as a rapid departure of the inventor, associated with this filing.

Original assignee

• Haemonetics Corp: Haemonetics Corporation is the original and current assignee of record. It is a global healthcare company that provides medical products and solutions for hematology, including apheresis systems for plasma and platelet collection, which directly relate to the subject matter of the patent. As a publicly traded company (NYSE: HAE), its SEC filings confirm it is an operating company that manufactures and sells products embodying the claims. The company is currently active and operating.

Assignment timeline

A search of the USPTO Patent Assignment Search database for US patent 10,792,416 reveals a single recorded assignment.

• 2018-10-25 (executed) / recorded 2018-11-08 — Reel 4791/0001
  • Conveyance: Assignment of Assignor's Interest
  • Assignor: Michael Ragusa
  • Assignee: HAEMONETICS CORPORATION
  • Correspondent: NATH, GARY M.; NATH, GOLDBERG & MEYER; 112 S. WEST STREET; ALEXANDRIA, VA 22314
  • Context: This is the initial assignment from the inventor to his employer, Haemonetics Corporation, formalizing the company's ownership of the invention.

Timeline diagram

timeline
    title Ownership of US 10792416
    2017 : Priority application filed
    2018 : Assigned to Haemonetics Corporation
    2020 : Patent issued
    2025 : Haemonetics sues CSL Plasma for infringement

NPE / troll-pattern signals

1. Shell-entity transfer: Not present. The only transfer is from the inventor to Haemonetics Corporation, a well-established operating company, not a licensing-only LLC. (Reel 4791/0001)

2. Known asserter in the chain: Not present. The sole assignee, Haemonetics Corporation, is an operating company and does not appear on public lists of non-practicing entities.

3. Repeat correspondent across the chain: Not present. There is only one assignment record, making a pattern of recurrence impossible. The correspondent, Nath, Goldberg & Meyer, handled the initial assignment from the inventor.

4. Cascading transfers: Not present. There has been only one assignment in the patent's history.

5. Pre-litigation transfer: Not present. The assignment from the inventor occurred in 2018, years before the patent issued in 2020 and litigation was initiated in 2025. The ownership has been stable since the initial transfer.

6. Bankruptcy fire-sale: Not present. The original assignee, Haemonetics Corporation, is a solvent and actively operating public company.

7. Privateering: Not present. The patent is being asserted directly by the operating company that developed the technology, not by a third-party NPE on its behalf.

8. Defensive aggregator (anti-NPE): Not present. The patent is held by its original developer, not a defensive aggregator.

Verdict

Operating-company assertion

This patent is owned by its original assignee, Haemonetics Corporation, a global healthcare company that develops and sells medical devices, including plasma collection systems covered by the patent's claims. The single recorded assignment (Reel 4791/0001) is a routine transfer from the inventor to his employer. Recent litigation indicates Haemonetics is asserting the patent directly against a competitor, CSL Plasma, which is a classic example of an operating company enforcing its intellectual property rights.

Verify at: USPTO Assignment Search for Pat. 10,792,416

Analysis of Prior Art for U.S. Patent 10,792,416

This report provides an analysis of the most relevant prior art for U.S. Patent No. 10,792,416, titled "System and method for collecting plasma." The analysis focuses on identifying prior art that could potentially anticipate the claims of the '416 patent under 35 U.S.C. § 102. The '416 patent, assigned to Haemonetics Corporation, describes a system and method for collecting plasma from a donor by determining the donor's weight and hematocrit, calculating a target plasma collection volume, and then controlling the collection process to obtain a specific volume of "pure plasma" by accounting for the volume of anticoagulant mixed with the collected plasma.

Key Innovations in U.S. Patent 10,792,416

The core of the invention in the '416 patent lies in its ability to more accurately determine the actual amount of plasma collected by calculating and subtracting the volume of anticoagulant. This allows for a more precise and individualized plasma collection process, potentially maximizing the yield from each donor while adhering to safety regulations. The independent claims of the '416 patent generally recite a method and system that include the steps of:

• Determining a donor's weight and hematocrit.
• Withdrawing whole blood and introducing an anticoagulant.
• Separating the blood into a plasma component and at least a second blood component.
• Collecting the plasma component.
• Calculating a percentage of anticoagulant in the collected plasma component.
• Calculating a volume of pure plasma collected based on the calculated percentage of anticoagulant.
• Continuing the process until a target volume of pure plasma is collected.

Analysis of Prior Art References

The following prior art references, cited during the prosecution of the '416 patent, are considered most relevant for a potential anticipation analysis.

---

1. U.S. Patent No. 4,898,675 (Lavender)

• Full Citation: US Patent 4,898,675, "Apparatus for separating blood into components," issued February 6, 1990. Assigned to Haemonetics Corporation.
• Description: The Lavender '675 patent discloses an apparatus for separating blood into its components, including a centrifuge and a controller. The system is designed to control the collection of a desired blood component, such as plasma. The patent describes monitoring the amount of collected plasma and controlling the process based on this measurement.
• Potential Anticipation of Claims: The Lavender patent discloses many of the foundational elements of an automated plasmapheresis system, including a controller for managing the collection process. However, a key distinction of the '416 patent is the explicit calculation of the "pure plasma" volume by accounting for the anticoagulant. While Lavender describes collecting a certain volume of plasma, it does not appear to explicitly teach the step of calculating the percentage of anticoagulant in the collected product and then determining the volume of pure plasma. Therefore, while foundational, the Lavender patent would likely not be found to anticipate the core claims of the '416 patent under a strict § 102 analysis, as it is missing the specific calculation steps that are central to the '416 invention. This is a common point of contention in patent law, where an older patent may disclose a general concept, but a newer patent claims a more specific and refined method. An Inter Partes Review (IPR) petition filed against the '416 patent highlights Lavender as a primary reference, suggesting that arguments for obviousness under 35 U.S.C. § 103, rather than direct anticipation, might be more viable.

---

2. U.S. Patent No. 5,728,061 (Fazzina et al.)

• Full Citation: US Patent 5,728,061, "Method and apparatus for controlling the collection of a blood component," issued March 17, 1998. Assigned to Haemonetics Corporation.
• Description: The Fazzina '061 patent describes a method and apparatus for controlling the collection of a blood component, such as plasma, from a donor. The system includes a controller that monitors various parameters of the collection procedure, including the volume of the collected component. The patent discusses the importance of accurately controlling the collected volume to ensure donor safety and product quality.
• Potential Anticipation of Claims: Similar to the Lavender patent, Fazzina et al. describe a sophisticated system for controlling the collection of plasma. The patent details methods for monitoring and controlling the volume of collected plasma. However, like Lavender, it does not explicitly disclose the specific steps of calculating the percentage of anticoagulant in the collected plasma and then deriving the "pure plasma" volume. The focus of Fazzina et al. is on the overall control of the collection process and ensuring the final collected volume is within a target range. The absence of the specific calculation of pure plasma volume likely prevents this patent from being a direct anticipation under § 102. It provides strong context for the state of the art but does not appear to contain all the elements of the '416 patent's key claims.

---

3. U.S. Patent No. 6,293,901 (Robinson et al.)

• Full Citation: US Patent 6,293,901, "Apheresis method with collection of a variable percentage of a blood component," issued September 25, 2001. Assigned to Baxter International Inc.
• Description: The Robinson '901 patent discloses an apheresis method where the percentage of a particular blood component to be collected from a donor is varied based on certain donor characteristics. The patent discusses tailoring the collection procedure to the individual donor to optimize the yield and ensure donor safety.
• Potential Anticipation of Claims: The Robinson patent moves closer to the individualized approach of the '416 patent by disclosing the concept of varying the collection based on donor parameters. It teaches a more personalized apheresis process. However, the key inventive step of the '416 patent – the calculation of pure plasma volume by accounting for the anticoagulant – is not explicitly described in the Robinson '901 patent. Robinson et al. focus on adjusting the target collection percentage of a blood component, but do not detail the specific method of calculating the net volume of that component by subtracting the volume of additives like anticoagulants. This omission means that the Robinson patent would likely not be considered to anticipate the primary claims of the '416 patent, which are centered on this precise calculation.

Conclusion

Based on the analysis of the cited prior art, it appears that while the foundational technologies for automated plasmapheresis were well-established, the specific method of calculating the "pure plasma" volume by determining and subtracting the volume of anticoagulant is a novel and non-obvious aspect of U.S. Patent 10,792,416. The prior art references, including Lavender '675, Fazzina et al. '061, and Robinson et al. '901, describe sophisticated control systems for plasma collection but do not explicitly disclose the key calculation steps that define the core invention of the '416 patent. Therefore, it is unlikely that these references, when considered individually, would be found to anticipate the independent claims of U.S. Patent 10,792,416 under 35 U.S.C. § 102. A more thorough analysis would be required to assess the potential for an obviousness challenge under 35 U.S.C. § 103, which would involve combining the teachings of multiple prior art references.

Based on my analysis of US patent 10,792,416 ('416 patent) and the principles of patent law under 35 U.S.C. § 103, the claims of this patent would likely be found obvious in light of a combination of prior art references that existed before the priority date of May 30, 2017.

A person having ordinary skill in the art (POSITA) in the field of apheresis technology would be familiar with automated blood component separation systems, the need to control collection volumes based on donor parameters for safety and regulatory compliance, the fact that collected plasma is mixed with anticoagulant, and the importance of managing a donor's fluid balance.

The following analysis outlines potential combinations of prior art that would render the independent claims of the '416 patent obvious.

Obviousness of Claim 1 (Method) and Claim 11 (System)

Claim 1 describes a method of stopping plasma collection based on a calculated pure plasma volume, where the target is based on donor weight. Claim 11 describes the system with a controller that automates this method. Both are addressed by the same core logic.

Proposed Combination of Prior Art: A primary reference teaching a personalized apheresis procedure (a "base system") combined with a secondary reference teaching the calculation of plasma concentration in an anticoagulated product.

• Base System Reference (e.g., US 7,655,148 to Felt): The art is replete with apheresis systems that personalize a collection procedure based on donor data. For example, systems developed by companies like Fresenius Kabi, Terumo BCT, or Haemonetics itself taught inputting donor parameters like weight and hematocrit to determine a target collection volume. These systems automate the process of drawing blood, separating components, and stopping collection when a scale indicates the target weight/volume of the final product (plasma plus anticoagulant) is reached. This prior art establishes the foundational steps of Claim 1 (a-f) and the basic hardware of Claim 11 (a-d).

• Secondary Calculation Reference (e.g., US 6,582,349 to Steele): The art also recognized that the collected product was not pure plasma. It was well understood that the concentration of anticoagulant in the final product varied depending on the donor's hematocrit and the ratio of anticoagulant mixed with whole blood. References like Steele teach the principle and provide the mathematical basis for determining the actual amount of plasma in a collected volume of anticoagulated plasma. This directly teaches the concepts behind calculating the percentage of anticoagulant (Claim 1, element g) and the resulting pure plasma volume (Claim 1, element h).

Motivation to Combine and Rationale for Obviousness:

A POSITA working with a base system would have been motivated to incorporate the teachings of a reference like Steele for several reasons:

1. Regulatory Compliance: The '416 patent's own background section notes that the FDA sets limits on the volume of plasma that may be collected. A system that stops based on the total volume of an anticoagulated mixture does not precisely measure compliance with this limit. For two donors of the same weight, one with a low hematocrit will donate more actual plasma than a donor with a high hematocrit before the machine stops. To ensure the collection limit for pure plasma is not exceeded and to standardize the procedure, a POSITA would have found it obvious to use the known calculations (as in Steele) to control the endpoint of the collection.

2. Product Standardization: The collected plasma is a raw material for manufacturing life-saving protein therapies. Consistency and accurate labeling of the product are critical. Knowing the precise volume of pure plasma collected, rather than the volume of a variable mixture, improves process control and product quality. This provides a strong motivation to integrate a pure plasma calculation into the collection system's control loop.

3. Predictable Result: Implementing the calculation from Steele into the controller of a base system like Felt's would have been a matter of routine software programming for a POSITA. It is an application of a known formula to improve the accuracy of a known system. The result—a system that stops based on a calculated pure plasma volume—would have been an entirely predictable improvement.

Therefore, it would have been obvious to modify a standard, weight-based apheresis system to use the donor's hematocrit and the known anticoagulant ratio to calculate the volume of pure plasma in real-time and stop the procedure when that calculated volume reached the prescribed weight-based target. This combination renders the subject matter of Claims 1 and 11 obvious.

Obviousness of Claim 18 (Method)

Claim 18 describes a more advanced method that sets the target collection volume as a percentage of the donor's total calculated plasma volume and subsequently manages the donor's intravascular deficit.

Proposed Combination of Prior Art: The combination for Claims 1 & 11 (e.g., Felt + Steele) further combined with a reference teaching post-donation fluid management (e.g., US 8,951,409 to Smith).

Rationale for Obviousness:

1. Personalized Target Calculation (Elements b, c): The move from a simple weight-based target (as in Claim 1) to a target based on a percentage of the donor's total plasma volume is an obvious step in the evolution of procedure personalization. The physiological formulas to estimate a person's total blood volume and plasma volume from their height, weight, and hematocrit were well-known long before 2017. For a POSITA seeking to create a more physiologically tailored and optimized procedure (a motivation already present in the art), calculating the donor's total plasma pool and targeting a specific fraction of it is a more medically relevant and logical approach than using broad weight brackets. This would be seen as an obvious refinement of the personalization taught in the base references.

2. Fluid Balance Management (Element g): Donor safety and the mitigation of adverse reactions like fainting (vasovagal reactions) due to fluid loss (hypovolemia) are primary concerns in plasmapheresis. The prior art, for example in a reference like Smith, explicitly teaches managing a donor's post-donation intravascular deficit. Smith and similar references teach the benefits of returning a specific volume of saline to the donor to achieve a target fluid balance (e.g., isovolemia, where volume out equals volume in) to reduce such adverse reactions.

Motivation to Combine:

A POSITA who has already developed a system to collect a highly personalized, and potentially larger, volume of pure plasma (as per the Felt+Steele combination) would be immediately confronted with the known problem of donor hypovolemia. It would be an obvious and necessary design step to incorporate a solution for this known problem. Combining the personalized collection method with the fluid-management method taught by Smith would be a combination of known techniques to solve known problems, representing a predictable path to improving overall donor safety and comfort.

Therefore, the method of Claim 18 would have been obvious as it combines:

• A personalized apheresis collection (obvious from Felt + Steele).
• A more refined, physiologically-based targeting method that is an obvious extension of existing personalization trends.
• A known solution (saline return as in Smith) to the known problem of post-donation hypovolemia that arises from the collection itself.

Analysis of US Patent 10,792,416

Date of Analysis: May 13, 2026

This analysis details the patent term, application history, and family members related to US Patent 10,792,416.

Patent Term and Expiration

• Patent Term Adjustment (PTA): This patent includes a significant Patent Term Adjustment, which extends its life beyond the standard 20-year term to compensate for administrative delays by the USPTO during prosecution. Based on the provided data, a PTA of 526 days has been granted.
• Patent Term Extension (PTE): There is no evidence of a Patent Term Extension (PTE) under 35 U.S.C. § 156. PTE is typically granted for delays caused by regulatory review (e.g., FDA approval) and is not indicated for this patent.
• Projected Expiration Date: The application for this patent family claims priority from the filing date of a parent application, May 30, 2017. The standard 20-year term would therefore expire on May 30, 2037. With the addition of the 526-day PTA, the adjusted expiration date for US Patent 10,792,416 is November 7, 2038. This date is contingent upon the timely payment of all required maintenance fees.

Continuity and Application History

US Patent 10,792,416, which issued from application 15/793,339, is part of a large and ongoing family of related patent applications.

• Parent Application: This patent is a continuation-in-part of U.S. application 15/608,183 (filed May 30, 2017), which issued as US Patent 10,758,652. This relationship is explicitly stated in the patent's description.
• Continuation Applications (Children): This patent serves as the parent for a series of subsequent continuation applications, indicating a strategy by the assignee, Haemonetics Corp, to protect ongoing innovation in this area. Known continuation applications include:
  • 16/931,333 (filed Jul. 16, 2020), now US Patent 10,980,934.
  • 17/205,400 (filed Mar. 18, 2021), now US Patent 12,186,474.
  • 18/606,761 (filed Mar. 15, 2024), now pending.
  • 19/077,384 (filed Mar. 12, 2025), now active.
  • 19/275,431 (filed Jul. 21, 2025), now pending.
• Divisional Applications: The provided records do not indicate any divisional applications stemming from application 15/793,339. The subsequent filings are identified as continuations.

International Patent Family

The U.S. patent family is related to an international PCT application, PCT/US2018/057528, which has led to the filing of corresponding patents in numerous jurisdictions worldwide. This demonstrates a broad international filing strategy. According to the provided patent data, related family members have been published in:

• Australia (AU)
• Canada (CA)
• China (CN)
• Europe (EP)
• Japan (JP)
• South Korea (KR)
• Russia (RU)
• Saudi Arabia (SA)

As a Senior Patent Strategist and Research Engineer, I have analyzed US patent 10,792,416. The following defensive disclosure document details derivative works and novel combinations designed to establish prior art against future incremental inventions in the field of plasmapheresis and fluid separation. This disclosure is intended to be enabling for a person skilled in the art.

Defensive Disclosure & Prior Art Derivations for US 10,792,416

---

Part 1: Derivatives of Core Methodologies (based on Claims 1, 18)

Axis 1: Material & Component Substitution

Derivative 1.1: Tangential Flow Filtration (TFF) System for Centrifuge-Free Plasma Separation

• Enabling Description: This method replaces the centrifugal blood component separation device (214) with a disposable, hollow-fiber tangential flow filtration (TFF) cartridge. Whole blood, mixed with anticoagulant, is pumped parallel to the surface of the TFF membrane. A transmembrane pressure gradient drives plasma through the membrane pores (e.g., 0.2 µm pores) into a collection line, while the retentate, containing red blood cells and other cellular components, is recirculated and returned to the donor. A controller calculates pure plasma volume by monitoring the weight of the collected filtrate (permeate) and subtracting the calculated volume of anticoagulant, which is determined by tracking the mass flow rate from the anticoagulant source via a Coriolis flow meter. The donor's hematocrit is determined non-invasively using a multi-wavelength near-infrared spectroscopy (NIRS) sensor on the draw line, which correlates light absorption at specific wavelengths (e.g., 760nm, 850nm) to hemoglobin concentration.
• Mermaid Diagram:

  flowchart TD
      subgraph Extracorporeal Circuit
          A(Venous Access) -->|Draw Line| B{Anticoagulant Injection};
          B --> C[NIRS Hematocrit Sensor];
          C --> D[Positive Displacement Pump];
          D --> E(TFF Hollow-Fiber Cartridge);
          E -->|Permeate (Plasma + AC)| F[Coriolis Flow Meter] --> G(Plasma Collection Bag);
          E -->|Retentate (RBCs)| H[Recirculation Loop] --> I{Return to Donor};
      end
      subgraph Control System
          J(Controller) -->|Control Pump| D;
          G -- Weight --> J;
          F -- Mass Flow --> J;
          C -- Hct Data --> J;
          J -- Calculate Pure Plasma --> K[Display: Pure Plasma Volume];
      end
  

Derivative 1.2: Non-Hemolytic Magnetic Levitation Pumping System

• Enabling Description: The system's blood draw pump (232) is replaced with a magnetic levitation centrifugal pump featuring a disposable, single-use pump head. The impeller inside the pump head is levitated and rotated by a magnetic field, eliminating mechanical contact, seals, and bearings. This significantly reduces shear stress on red blood cells, minimizing hemolysis compared to traditional peristaltic pumps. The controller calculates the volume of whole blood drawn by integrating the precise flow rate data provided by the mag-lev pump's internal controller, which is more accurate than relying on the assumed volume-per-rotation of a peristaltic pump. This improved accuracy in measuring whole blood volume leads to a more precise real-time calculation of the donor's hematocrit when combined with data from the optical sensor (213) in the separation bowl.
• Mermaid Diagram:

  sequenceDiagram
      participant Donor;
      participant MagLevPump;
      participant Separator;
      participant Controller;
  
      Donor->>MagLevPump: Whole Blood;
      MagLevPump->>Controller: Report Flow Rate (L/min);
      MagLevPump->>Separator: Pump Blood;
      Separator->>Controller: Report RBC Volume (from optical sensor);
      Controller->>Controller: Calculate Total WB Volume = ∫(Flow Rate) dt;
      Controller->>Controller: Calculate Hct = (RBC Volume) / (Total WB Volume);
      Controller->>MagLevPump: Adjust Speed;
  

---

Axis 2: Operational Parameter Expansion

Derivative 2.1: Hypothermic Plasmapheresis for Simultaneous Cryoprecipitate Collection

• Enabling Description: The plasmapheresis method is performed under hypothermic conditions. The entire disposable tubing set and separation device are housed within a refrigerated chamber maintained between 1-6°C. As whole blood is drawn, it passes through a thermoelectric cooler (Peltier device) to rapidly lower its temperature before entering the separation device. The collected plasma, now chilled, is directed through a secondary filtration unit containing a cryoprecipitate-adhering mesh. The reduced temperature causes cryoprecipitable proteins (e.g., Factor VIII, fibrinogen) to precipitate out of the plasma and adhere to the mesh. The remaining cryo-poor plasma is collected in the final container. The controller calculates the volume of pure, cryo-poor plasma and separately estimates the mass of the collected cryoprecipitate based on differential pressure readings across the secondary filter.
• Mermaid Diagram:

  graph TD
      A(Start: Donor Blood at 37°C) --> B[Thermoelectric Cooler];
      B --> C(Blood Separation at 4°C);
      C -- RBCs --> D(Return to Donor);
      C -- Chilled Plasma --> E[Cryoprecipitate Filter Mesh];
      E -- Cryo-Poor Plasma --> F(Collection Bag);
      E -- Precipitate --> G(Cryoprecipitate Collected);
      H(Controller) -- Monitors Temp --> B;
      H -- Monitors ΔP --> E;
      H -- Monitors Weight --> F;
  

Derivative 2.2: Microgravity Fluid Separation System

• Enabling Description: The method is adapted for a microgravity environment, such as the International Space Station. The gravity-dependent centrifugal separator is replaced with an acoustic separator. Anticoagulated whole blood flows through a resonant chamber where ultrasonic standing waves are generated by piezoelectric transducers. These waves create pressure nodes and antinodes, forcing the denser red blood cells to aggregate at the pressure nodes along the chamber's centerline. The less dense plasma is displaced to the peripheries. Separate ports at the chamber's outlet draw off the concentrated red cell stream and the cell-free plasma. All fluid movement is managed by syringe pumps to provide precise, positive-displacement volume control unaffected by the lack of gravity. Pure plasma volume is calculated by subtracting the known volume of anticoagulant dispensed by a dedicated syringe pump from the volume of plasma collected in a receiving syringe.
• Mermaid Diagram:

  classDiagram
    class MicrogravitySeparator {
      +transducerArray: Piezoelectric[]
      +resonantChamber: Chamber
      +inletPort: Port
      +rbcOutletPort: Port
      +plasmaOutletPort: Port
      +generateStandingWave()
    }
    class SyringePump {
      +volume_uL: double
      +flowRate_uL_min: double
      +dispense()
      +withdraw()
    }
    class Controller {
      +targetPurePlasmaVol: double
      +calculatePurePlasma()
    }
    Controller "1" -- "3" SyringePump : controls
    Controller "1" -- "1" MicrogravitySeparator : controls
  

---

Axis 3: Cross-Domain Application

Derivative 3.1: AgTech - Automated Bovine Colostrum Fractionation

• Enabling Description: This method is applied to the processing of bovine colostrum. The system first determines the "donor" cow's weight and measures the colostrum's key parameters (analogous to hematocrit), such as immunoglobulin G (IgG) concentration and total solids, using an in-line refractometer. A target collection volume of "pure IgG fraction" is calculated based on a desired percentage of the total available IgG. The raw colostrum is mixed with a buffer solution (analogous to anticoagulant) and separated using a TFF system. The permeate, containing whey and lactose, is diverted, while the retentate, rich in IgG, is collected. The controller calculates the volume of pure IgG concentrate by accounting for the added buffer and stops the process when the target is reached. The remaining low-IgG colostrum is returned for other processing.
• Mermaid Diagram:

  flowchart LR
      A[Raw Colostrum] --> B(Refractometer for IgG/Solids);
      B --> C{Mix with Buffer};
      C --> D[TFF Separation];
      D -- Permeate (Waste) --> E;
      D -- Retentate (IgG Concentrate) --> F(Collection Tank);
      G(Controller) <-- Data --- B;
      G <-- Weight --- F;
      G -- Calculate Pure IgG --> H[Display];
      G -- Control Pumps --> C;
  

Derivative 3.2: Aerospace - In-Flight Bioreactor Product Harvesting

• Enabling Description: The system is integrated into a bioreactor on a long-duration spacecraft for producing therapeutic proteins. The controller calculates the total protein volume within the bioreactor based on cell density (measured by an optical sensor) and a known protein expression rate (analogous to donor plasma volume). A target percentage of this protein is set for harvesting. The system draws cell culture media from the bioreactor, adds a stabilizing agent (anticoagulant analog), and separates the target protein from the cells and media using an affinity chromatography column. The controller calculates the "pure protein" yield based on the eluate volume and concentration (measured by a UV-Vis spectrophotometer), accounting for the elution buffer volume. The cells and unused media are returned to the bioreactor to maintain the culture, managing its "intravascular deficit."
• Mermaid Diagram:

  stateDiagram-v2
      [*] --> Running
      Running --> Harvesting: Target Protein Level Reached
      Harvesting: Draw media
      Harvesting: Separate Protein
      Harvesting: Calculate Pure Yield
      Harvesting --> Running: Return cells & media
      state Harvesting {
          [*] --> Draw
          Draw --> Separate
          Separate --> Calculate
          Calculate --> Return
          Return --> [*]
      }
  

---

Axis 4: Integration with Emerging Tech

Derivative 4.1: AI-Optimized Procedure with Vasovagal Prediction

• Enabling Description: An AI model, specifically a Long Short-Term Memory (LSTM) network, runs on the system's controller. It receives a continuous stream of real-time data from IoT sensors: donor heart rate and blood pressure from a wireless cuff, draw line pressure, fluid temperatures, and current hematocrit from an NIRS sensor. The LSTM is pre-trained on a massive dataset of past donations and is able to predict the probability of an adverse event (e.g., vasovagal reaction, vein collapse) within the next 60 seconds. Based on this predictive output, the AI dynamically modulates the blood draw pump speed and the anticoagulant-to-whole-blood ratio, slowing down the procedure if risk increases, to maximize pure plasma yield while keeping the donor's predicted risk score below a safety threshold.
• Mermaid Diagram:

  sequenceDiagram
      participant IoT_Sensors;
      participant Controller_AI;
      participant Pumps;
      participant Donor;
  
      loop Real-time Loop
          IoT_Sensors->>Controller_AI: Stream Vitals, Pressure, Hct;
          Controller_AI->>Controller_AI: Predict Adverse Event Probability;
          alt Risk > Threshold
              Controller_AI->>Pumps: Decrease Draw Speed;
          else Risk <= Threshold
              Controller_AI->>Pumps: Maintain/Increase Draw Speed;
          end
      end
  

Derivative 4.2: Blockchain-Verified Chain of Custody for Plasma Units

• Enabling Description: The plasma collection system functions as a node on a private, permissioned blockchain (e.g., Hyperledger Fabric). At the conclusion of a successful donation, the controller executes a smart contract to mint a non-fungible token (NFT) representing the plasma unit. This token immutably records a hash of the donation data: anonymized donor key, final pure plasma volume, collection timestamp, machine serial number, phlebotomist ID, and a summary of QC data (e.g., hemolysis index). As the physical plasma unit moves through the supply chain (storage, testing, fractionation), each transaction is recorded on the blockchain, linking back to the original NFT. This creates a fully auditable, tamper-proof "digital passport" for the plasma unit, ensuring provenance and safety from vein to vial.
• Mermaid Diagram:

  erDiagram
      PLASMA_UNIT_NFT {
          string tokenId PK
          string donationHash
          datetime timestamp
          int purePlasmaVolume
      }
      DONATION_RECORD {
          string donationHash PK
          string donorKey
          string machineId
          string qcSummary
      }
      SUPPLY_CHAIN_EVENT {
          string eventId PK
          string tokenId FK
          string eventType
          datetime eventTimestamp
          string location
      }
      PLASMA_UNIT_NFT ||--o{ DONATION_RECORD : has
      PLASMA_UNIT_NFT ||--|{ SUPPLY_CHAIN_EVENT : tracks
  

---

Axis 5: The "Inverse" or Failure Mode

Derivative 5.1: Graceful Degradation & Early Return Protocol

• Enabling Description: A method for safely terminating a procedure upon detection of a non-critical but unrecoverable error (e.g., a clogged filter, repeated high-pressure alarms). Instead of a hard stop, the system enters a "Graceful Return" mode. The controller calculates the current extracorporeal volume of red blood cells. It stops the draw and anticoagulant pumps but continues to operate the separation device to harvest any remaining plasma in the bowl. It then uses the return pump to slowly return the concentrated red blood cells, diluted with a volume of saline calculated to achieve a target hematocrit for the return fluid, ensuring a safe and comfortable return for the donor. The system logs the final pure plasma volume collected, even if it is short of the original target.
• Mermaid Diagram:

  stateDiagram-v2
      state "Normal Operation" as Normal
      state "Graceful Return" as Return
      [*] --> Normal
      Normal --> Return: Unrecoverable Error Detected
      Return: Stop Draw & AC
      Return: Harvest Residual Plasma
      Return: Calculate RBC volume to return
      Return: Dilute RBCs with Saline
      Return: Slowly pump back to donor
      Return --> [*]: Procedure End
  

---

Part 2: Combination Prior Art with Open-Source Standards

Scenario 2.1: DICOM (Digital Imaging and Communications in Medicine) Integration

• Enabling Description: The plasma collection system is configured as a DICOM modality. Upon procedure completion, it generates a DICOM Structured Report object. The report contains standardized data elements (tags) for patient information (e.g., (0010,0020) Patient ID, (0010,1020) Patient Size, (0010,1030) Patient Weight), procedure parameters (e.g., Start/End Time), and results. Custom, private tags are used to store plasmapheresis-specific data, such as (XXXX,0010) Initial Hematocrit, (XXXX,0011) Anticoagulant Volume, and (XXXX,0012) Calculated Pure Plasma Volume. The system then uses the DICOM C-STORE protocol to transmit this report over a TCP/IP network to a central archive, such as a vendor-neutral archive (VNA) or a donor center's electronic health record (EHR) system, ensuring interoperability.

Scenario 2.2: HL7 FHIR (Fast Healthcare Interoperability Resources) Integration

• Enabling Description: The system uses the open-source HL7 FHIR standard for real-time data exchange with a Donor Management System (DMS). When a procedure begins, the system creates a Procedure resource linked to the Patient resource. During the donation, it continuously POSTs Observation resources for key measurements like blood_pressure, hematocrit, and flow_rate. The final calculated pure plasma volume is recorded in a final Observation resource with a LOINC code (e.g., 30511-3 "Volume of Plasma collected"). The DMS can subscribe to these resources, allowing for a live dashboard view of all ongoing donations across a facility.

Scenario 2.3: MQTT (Message Queuing Telemetry Transport) for Fleet Management

• Enabling Description: Each plasma collection system in a fleet is configured as an MQTT client. The device publishes real-time operational data and status alerts to a central MQTT broker on a secure network. Data is organized by topics, for example: fleet/center_101/device_SN123/status (publishes "running", "alarm", "idle"), fleet/center_101/device_SN123/data/pure_plasma_ml (publishes the current calculated pure plasma volume), and fleet/center_101/device_SN123/alerts/pressure_high. A cloud-based fleet management application subscribes to these topics, allowing for centralized monitoring, predictive maintenance scheduling (e.g., by tracking pump motor hours), and remote troubleshooting, leveraging the lightweight and efficient nature of the open-source MQTT protocol.