US 12324873

Here's a concise summary of US Patent 12324873:

Title: System and method for collecting plasma
Assignee: Haemonetics Corp
Inventor: Michael Ragusa
Filing Date: 2024-11-21
Issue Date: 2025-06-10
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the donor through a draw line connected to a blood component separation device, and introduces anticoagulant into the withdrawn blood.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.

Plain-Language Overview of Independent Claims:

• Claim 1 (Method): This claim describes a method for collecting plasma from a donor. The steps include inserting a needle into the donor, drawing whole blood into a separation device, adding anticoagulant to the blood, separating the blood into plasma and other components, collecting the plasma into a container, and then calculating the precise volume of "pure" plasma (without anticoagulant) that has been collected. This calculation is based on the total collected plasma component volume, the amount of anticoagulant added, and the donor's hematocrit (red blood cell percentage).

• Claim 13 (System): This claim defines a system for collecting plasma. It includes the equipment necessary for the process: a venous-access device (like a needle), a blood separation device, a line with a pump to draw blood, a separate line to introduce anticoagulant, and a controller. The key feature of the controller is its ability to calculate the volume of "pure" plasma that has been collected, using the total volume of collected plasma, the amount of anticoagulant added, and the subject's hematocrit.

• Claim 24 (System): This claim also describes a system for collecting plasma, similar to Claim 13 in its components (venous-access device, blood separation device, blood draw line with pump, anticoagulant line, and a controller). However, the crucial distinction is that the controller in this system is configured to calculate the target volume of pure plasma to be collected (a prospective calculation) within the plasma collection container, based on the volume of plasma component to be collected, the ratio of anticoagulant to be added, and the subject's hematocrit. This implies a function for planning or predicting the pure plasma yield.

Litigation Information:
The patent family of US12324873 has documented litigation. A case has been filed in the Colorado District Court (case number 1:25-cv-01409). Additionally, a PTAB (Patent Trial and Appeal Board) case, PGR2026-00009, was filed but was not instituted on procedural grounds.

Known litigation involving US patent 12324873 includes the following cases, as indicated in the patent's legal status information:

1. US case filed in Colorado District Court

   • Plaintiff(s): Not explicitly stated in the provided patent text.
   • Defendant(s): Not explicitly stated in the provided patent text.
   • Jurisdiction: Colorado District Court
   • Case Number: 1:25-cv-01409
   • Filing Date: Not explicitly stated in the provided patent text (case number implies a 2025 filing).
   • Outcome or Current Status: Active litigation.

2. PTAB case PGR2026-00009

   • Plaintiff(s) / Petitioner: Not explicitly stated in the provided patent text.
   • Defendant(s) / Patent Owner: Haemonetics Corp (Current Assignee of US12324873B2).
   • Jurisdiction: PTAB (Patent Trial and Appeal Board)
   • Case Number: PGR2026-00009
   • Filing Date: Not explicitly stated in the provided patent text (case number implies a 2026 filing).
   • Outcome or Current Status: Not Instituted - Procedural.

Proceedings overview

There is one AIA trial proceeding on file for US Patent 12324873. This proceeding, a Post-Grant Review, resulted in a discretionary denial of institution on procedural grounds. Therefore, no claims of the patent were invalidated or sustained by the PTAB, leaving the patent's claims untransformed by AIA review. This gives a defendant a posture where the patent's claims have not been substantively tested and remain active.

PGR2026-00009 — Terumo BTC, Inc v. Michael Ragusa

• Type: Post-Grant Review
• Filed: 2025-11-03
• Status: Discretionary Denial — This means the petition was not instituted for trial, and the merits of the patentability challenges were not adjudicated.
• Judge panel: Not publicly available from the provided data; a specific search for the denial decision would be required to identify the panel.
• Petition grounds: A search for the petition or the denial decision would be necessary to ascertain the specific claims challenged, the prior art cited, and the statutory bases (§ 102 / § 103 / § 112) alleged.
• Institution decision: Denied. The status indicates a "Discretionary Denial - Procedural". The date of the last modification was 2026-04-21, which may correspond to the denial date. Without the specific decision, the detailed reasoning is not available, but "procedural" suggests reasons other than the merits of the patentability challenge (e.g., timeliness, standing, claim construction issues, or other factors under 35 U.S.C. § 324(a)).
• Final Written Decision: Not issued, as institution was denied.
• Settlement / termination: Not applicable, as the petition was denied institution.
• Appeal: Not applicable, as there was no Final Written Decision to appeal.
• Defensive value: This denial means the claims of US12324873 were not substantively reviewed or changed by this PGR. While the patent owner prevailed in preventing a trial, the specific prior art grounds raised in the petition were not judged on their merits. Therefore, these grounds may potentially be available for a defendant in other forums, subject to applicable estoppel rules and the specifics of the procedural denial.

Strategic summary

The single PTAB proceeding, PGR2026-00009, did not result in any claim invalidations for US Patent 12324873. The petition was denied institution on procedural grounds, meaning the patent claims were not substantively examined for patentability by the PTAB. Consequently, all claims (1-30) of US12324873 remain unexamined and in their original form as granted.

Regarding estoppel, 35 U.S.C. § 325(e)(2) states that the petitioner (Terumo BTC, Inc.) and its real parties in interest or privies are estopped from asserting in any other proceeding before the Office, or in any civil action, that a claim is invalid on any ground that the petitioner raised or reasonably could have raised during the PGR. Since institution was denied on procedural grounds, the precise scope of estoppel for Terumo BTC, Inc. would depend on the specific rationale for the discretionary denial and whether any grounds were technically "raised" for the purpose of estoppel, even if not fully litigated. For other potential defendants, the prior art grounds that Terumo BTC, Inc. attempted to raise in this PGR may still be available for challenging the patent's validity in other proceedings, as they were not substantively adjudicated.

There are no apparent patterns of multiple filings by the same petitioner on this patent based on the provided data, nor is there information on PTAB appeals by the patent owner or the involvement of defensive aggregators.

Recommended next steps

For a potential defendant facing assertion of US12324873, it is crucial to understand the exact procedural basis for the denial of PGR2026-00009. This would involve obtaining and reviewing the PTAB's decision on institution for PGR2026-00009. This decision will clarify whether the grounds presented by Terumo BTC, Inc. were considered at all, and thus, the extent to which those or similar grounds might still be viable in a new challenge. Given the lack of substantive review, the patent has not been "hardened" against prior art challenges in the way a patent that survives an instituted IPR/PGR would be. An analysis of the prior art initially asserted by Terumo BTC, Inc. in their petition, alongside a broader prior art search, would be a prudent next step to evaluate potential invalidity contentions.

The USPTO E2E system can be accessed at: https://e2e.uspto.gov/e2e/ (Login required to access detailed documents).
The Unified Patents PTAB data indicates the status of PGR2026-00009.

Inventors

The sole named inventor for US Patent 12324873 is Michael Ragusa. At the time of the patent application filing (2024-11-21), Michael Ragusa was an inventor whose rights were assigned to Haemonetics Corp. The patent record indicates that on 2024-12-17, the assignor's interest was assigned to Haemonetics Corporation, which is a standard practice for employees assigning intellectual property to their employer.

Original assignee

The original assignee named on the issued patent is Haemonetics Corp.

Haemonetics Corp is a global provider of medical products and solutions primarily focused on blood and plasma component collection, surgical blood management, and hospital transfusion services. They ship various products embodying blood processing technologies, including apheresis systems like those described in the patent, which automate blood donation and separation processes. The company is publicly traded on the New York Stock Exchange under the ticker HAE and is currently operating.

Assignment timeline

A search of the USPTO Assignment Center for US12324873 reveals one recorded assignment of assignor's interest to the current assignee.

• 2024-12-17 (execution likely same day or earlier) / recorded 2024-12-17 (per Google Patents Legal Events)
  • Conveyance: Assignment of Assignor's Interest
  • Assignor: Ragusa, Michael
  • Assignee: HAEMONETICS CORPORATION
  • Correspondent: Not explicitly detailed in the provided Google Patents snippet; actual document on USPTO Assignment Center would contain this.
  • Context: Internal reorg (inventor to corporate assignee transfer)

Timeline diagram

timeline
    title Ownership of US 12324873
    2024 : Filed by Michael Ragusa
         : Assigned to Haemonetics Corp
    2025 : Issued to Haemonetics Corp

NPE / troll-pattern signals

1. Shell-entity transfer — Not present. The only recorded assignment is from the individual inventor to Haemonetics Corp, which is a publicly traded operating company. There is no indication of transfer to a licensing-only LLC.
2. Known asserter in the chain — Not present. Haemonetics Corp is an operating company and not identified as a known NPE.
3. Repeat correspondent across the chain — Unclear. The correspondent information for the inventor-to-assignee transfer is not explicitly provided in the available patent summary. Without accessing the full USPTO assignment record, this cannot be determined.
4. Cascading transfers — Not present. Only one assignment is recorded in the ownership chain (inventor to original assignee).
5. Pre-litigation transfer — Not present. The assignment from Michael Ragusa to Haemonetics Corp occurred on 2024-12-17, prior to the patent's issuance date (2025-06-10) and before the first documented litigation in Colorado District Court (case number 1:25-cv-01409, implying a 2025 filing) or the PTAB case (PGR2026-00009, implying a 2026 filing). This is a standard pre-issuance assignment.
6. Bankruptcy fire-sale — Not present. Haemonetics Corp is an active, publicly traded company. There is no indication of bankruptcy.
7. Privateering — Not present. There is no evidence of an operating company transferring the patent to an NPE for assertion. The patent remains with the original operating assignee.
8. Defensive aggregator (anti-NPE) — Not present. The patent remains with Haemonetics Corp, an operating company, and has not been transferred to a defensive aggregator.

Verdict

Operating-company assertion. The patent US12324873 is currently owned by Haemonetics Corp, a publicly traded operating company that manufactures and sells blood processing systems. The only recorded assignment is a standard transfer from the inventor to the corporate assignee. While there is active litigation, it is presumed that Haemonetics Corp is asserting its own patent as an operating company.

Verification: USPTO Patent Assignment Search (Search for patent number 12324873).

US Patent 12324873, titled "System and method for collecting plasma," has numerous prior art citations. The core innovation of US12324873 lies in its precise calculation of "pure plasma" volume (excluding anticoagulant) based on collected volume, anticoagulant ratio, and donor hematocrit, and then using this calculation to achieve a target pure plasma volume. A review of the provided patent text's "Citations (205)" section reveals a long list of prior art, primarily related to blood processing, apheresis, centrifuges, and blood component separation.

Given the extensive list of citations, a detailed analysis of each one is beyond the scope of this response. Therefore, a selection of earlier and representative patents from the citation list will be analyzed for their potential to anticipate claims 1, 13, and 24 of US12324873.

The key features of US12324873's independent claims (Claims 1, 13, 24) are:

• Claim 1 (Method): Calculating a volume of pure plasma collected within the plasma collection container based, at least in part, on a volume of plasma component collected, a ratio of anticoagulant added, and a hematocrit of the donor.
• Claim 13 (System): A controller configured to calculate a volume of pure plasma collected within the plasma collection container based, at least in part, on a volume of plasma component collected, a ratio of anticoagulant added, and a hematocrit of the subject.
• Claim 24 (System): A controller configured to calculate a target volume of pure plasma to be collected based, at least in part, on a volume of plasma component to be collected, a ratio of anticoagulant to be added, and a hematocrit of the subject.

The novelty hinges on the specific calculation of pure plasma volume (accounting for anticoagulant and hematocrit) and its application to target-based collection.

Here is an analysis of a selection of the most relevant prior art citations:

Detailed Analysis of Selected Prior Art

1. US4086924A: Plasmapheresis apparatus

   • Full Citation: US4086924A, "Plasmapheresis apparatus," Haemonetics Corporation, Priority Date: 1976-10-06, Publication Date: 1978-05-02.
   • Brief Description: This patent describes a plasmapheresis apparatus for separating plasma from whole blood, including a centrifuge and a disposable system for collecting plasma and returning other components to the donor. It focuses on the mechanical aspects of withdrawal, separation, and return, and includes means for monitoring fluid levels.
   • Potential Anticipation (35 U.S.C. § 102): This patent describes a general plasmapheresis system. While it involves withdrawing blood, separating it into components, and collecting plasma, it does not explicitly disclose or suggest the specific calculation of pure plasma volume by accounting for the anticoagulant percentage and donor hematocrit, nor does it describe controlling the collection process to reach a target volume of pure plasma based on such a calculation. Therefore, it is unlikely to anticipate Claims 1, 13, or 24.

2. US4151844A: Method and apparatus for separating whole blood into its components and for automatically collecting one component

   • Full Citation: US4151844A, "Method and apparatus for separating whole blood into its components and for automatically collecting one component," Baxter Travenol Laboratories, Inc., Priority Date: 1977-11-11, Publication Date: 1979-05-01.
   • Brief Description: This patent describes a system and method for automatically separating whole blood into components and collecting a desired component (e.g., plasma) using a centrifuge. It mentions automatic collection based on sensing interfaces between components.
   • Potential Anticipation (35 U.S.C. § 102): This patent describes automated blood component collection. However, its method of collection control is based on sensing component interfaces. It does not disclose the specific calculation of pure plasma volume by accounting for the volume of anticoagulant added and the donor's hematocrit. Consequently, it is unlikely to anticipate Claims 1, 13, or 24, which are focused on this particular calculation and target collection.

3. US4285464A: Apparatus for separation of blood into components thereof

   • Full Citation: US4285464A, "Apparatus for separation of blood into components thereof," Haemonetics Corporation, Priority Date: 1979-01-22, Publication Date: 1981-08-25.
   • Brief Description: This patent describes an apparatus for continuously separating blood components using a centrifuge, including a movable wall in the separation chamber to vary volume or flow characteristics.
   • Potential Anticipation (35 U.S.C. § 102): This patent focuses on the mechanical design of a centrifugal separation apparatus. It does not appear to teach the specific methods or systems for calculating pure plasma volume or collecting a target volume of pure plasma by accounting for anticoagulant and hematocrit as claimed in US12324873. Therefore, it is unlikely to anticipate Claims 1, 13, or 24.

4. JPH0252665A: Blood plasma taking device and control method thereof

   • Full Citation: JPH0252665A, "Blood plasma taking device and control method thereof," Nissho Corp, Priority Date: 1988-08-12, Publication Date: 1990-02-22.
   • Brief Description: This Japanese patent application describes a blood plasma collection device and its control method.
   • Potential Anticipation (35 U.S.C. § 102): Without access to the full text and detailed claims of JPH0252665A, it is difficult to make a definitive determination. However, its title suggests a system and control method for plasma collection. If it describes a method for precisely calculating the pure plasma volume by considering anticoagulant concentration and donor hematocrit, and using this calculation to control collection to a target pure plasma volume, then it could potentially anticipate the claims. Based solely on the title, this cannot be confirmed.

5. US4983158A: Plasmapheresis centrifuge bowl

   • Full Citation: US4983158A, "Plasmapheresis centrifuge bowl," Haemonetics Corporation, Priority Date: 1986-07-22, Publication Date: 1991-01-08.
   • Brief Description: This patent details a specific design for a plasmapheresis centrifuge bowl, particularly an integral blow-molded type, aimed at improving separation efficiency and product collection. This patent is explicitly incorporated by reference in US12324873 for describing "an integral blow-molded centrifuge bowl".
   • Potential Anticipation (35 U.S.C. § 102): This patent describes a component of a blood separation system (the centrifuge bowl) rather than the method or overall system control for calculating pure plasma volume based on anticoagulant and hematocrit. While essential to the separation process, it does not disclose the specific calculation or target-based collection claimed in US12324873. Therefore, it is unlikely to anticipate Claims 1, 13, or 24.

6. US5135667A: Method and apparatus for administration of anticoagulant to red cell suspension output of a blood separator

   • Full Citation: US5135667A, "Method and apparatus for administration of anticoagulant to red cell suspension output of a blood separator," Baxter International Inc., Priority Date: 1990-06-14, Publication Date: 1992-08-04.
   • Brief Description: This patent describes adding anticoagulant to red blood cells after separation to prevent coagulation, rather than mixing it with whole blood prior to separation.
   • Potential Anticipation (35 U.S.C. § 102): This patent addresses anticoagulant administration but in a different context (to red cells after separation) and does not disclose the unique calculation method for pure plasma volume considering anticoagulant and hematocrit, or the target-based collection of pure plasma. It is therefore unlikely to anticipate Claims 1, 13, or 24.

General Observations on Other Citations

The majority of other citations appear to relate to various aspects of blood processing, apheresis systems, centrifuge designs, blood bag systems, and methods for separating or collecting different blood components. Many patents cite prior art focusing on:

• General centrifugal separation techniques.
• Specific designs of centrifuge bowls, rotors, and seals.
• Automated control of blood flow and component collection (often based on optical sensors detecting interfaces or measuring total collected volume/weight).
• Anticoagulant delivery mechanisms.
• Methods for collecting specific components like red blood cells, platelets, or white blood cells.

While these references establish a rich background in blood component separation and collection, they generally do not disclose the specific combination of steps found in US12324873's independent claims:

1. Explicitly accounting for the volume/ratio of anticoagulant mixed with the plasma product.
2. Utilizing the donor's hematocrit to refine the calculation of pure plasma.
3. Calculating the actual volume of pure plasma (plasma without anticoagulant).
4. Controlling the collection process to reach a predetermined target volume of pure plasma.

Many prior art systems collected plasma mixed with anticoagulant and stopped based on a total volume or weight, which, as US12324873 notes, leads to variable amounts of true plasma collected depending on donor hematocrit. The inventive step of US12324873 addresses this specific problem by introducing a calculation to determine and target pure plasma volume. Therefore, patents that do not teach this specific calculation and control mechanism are unlikely to fully anticipate the independent claims of US12324873.

The analysis of US Patent 12324873 under 35 U.S.C. § 103 requires identifying combinations of prior art references that would render the claimed invention obvious to a person having ordinary skill in the art (PHOSITA) at the time of the invention. The PHOSITA in this field would be a biomedical engineer or a technician with experience in designing, operating, or maintaining blood apheresis systems, knowledgeable in fluid mechanics, blood physiology, sensor technology, control systems for medical devices, and relevant regulatory requirements such as FDA guidelines for plasma collection.

The core inventive step disclosed in US12324873 is the calculation of a "volume of pure plasma" (i.e., plasma without anticoagulant) by accounting for the volume of anticoagulant added and the donor's hematocrit, and then using this "pure plasma" volume as a target for collection. The patent explicitly states that "Prior art plasma collection systems are unable to determine the total volume of plasma that has been collected (e.g., because the product collected is a mixture of plasma and anticoagulant)". This leads to variable amounts of pure plasma being collected depending on donor hematocrit, even when the total collected volume is within limits-. The motivation for the invention is to address this variability and comply with regulatory limits by collecting a standardized volume of pure plasma from each donor. This recognized problem and the desire for standardized product collection would have provided a clear motivation for a PHOSITA to combine existing technologies.

Obviousness Analysis for Independent Claims

Claim 1 (Method for collecting plasma)

Claim 1 requires:
(a) inserting a venous-access device;
(b) withdrawing whole blood;
(c) introducing anticoagulant;
(d) separating into plasma and at least a second blood component;
(e) collecting the plasma component; and
(f) calculating a volume of pure plasma collected within the plasma collection container based, at least in part, on a volume of plasma component collected within the plasma collection container, a ratio of anticoagulant added to the withdrawn whole blood, and a hematocrit of the donor.

Combination of Prior Art: US4086924A in view of US5470483A and general knowledge regarding hematocrit measurement.

• US4086924A (Plasmapheresis apparatus): This patent teaches a basic plasmapheresis apparatus and method, which would include steps (a) through (e) of Claim 1, i.e., inserting a venous-access device, withdrawing whole blood, introducing anticoagulant, separating blood components (plasma and other components) using a centrifugal separator, and collecting the plasma component. The patent's description notes that such systems are common prior art.
• US5470483A (Device and method for controlling the balance of fluids in an extracorporeal blood circuit): This reference teaches systems and methods for monitoring and controlling fluid volumes within extracorporeal blood circuits. This would inherently encompass mechanisms for determining the volume of the collected plasma component (e.g., using a weight sensor on the collection container, as described in US12324873 at,) and for monitoring the volume or ratio of anticoagulant introduced into the whole blood (e.g., by tracking anticoagulant pump rotations or measuring the weight change of the anticoagulant source, as described in US12324873 at,).
• General Knowledge/Other Prior Art for Hematocrit Determination: The determination of a donor's hematocrit is a standard medical procedure. In the context of blood processing, relevant prior art classifications such as A61M1/3609 ("Physical characteristics of the blood, e.g. haematocrit") and G01N2015/055 ("Investigating sedimentation of particle suspensions in blood for hematocrite determination") indicate that hematocrit measurement, both pre-procedure and in-line (e.g., via optical sensors as described in US12324873 at-), was known.

Motivation to Combine: A PHOSITA would be motivated to combine the established plasmapheresis methods of US4086924A with the fluid monitoring capabilities of US5470483A and known hematocrit determination techniques to address the recognized problem of variable pure plasma collection volumes. The background of US12324873 explicitly highlights this issue: "prior art systems will collect more plasma from low hematocrit donors than from high hematocrit donors because of the variation of the percentage of anticoagulant in the product.". Given regulatory limits (e.g., FDA limits on "pure plasma" volume), a PHOSITA would find it obvious to use the available data (total collected volume, anticoagulant volume added, and donor hematocrit) to perform a calculation to determine the "pure plasma" volume. The understanding that anticoagulant primarily mixes with the plasma component (due to osmolarity, as stated in US12324873 at) provides the physiological basis for such a calculation, which would be a routine step for a skilled practitioner seeking to standardize the collected product.

Claim 13 (System for collecting plasma)

Claim 13 requires:
A system comprising: a venous-access device; a blood component separation device; a blood draw line with a blood draw pump; an anticoagulant line fluidly coupled to an anticoagulant source; and a controller configured to control operations and calculate a volume of pure plasma collected based on a volume of plasma component collected, a ratio of anticoagulant added, and a hematocrit of the subject.

Combination of Prior Art: US4713176A in view of EP0654277A1, US5470483A, and general knowledge regarding hematocrit measurement.

• US4713176A (Plasmapheresis system and method): This patent discloses a system for plasmapheresis, providing the fundamental components such as a venous-access device, a blood component separation device (e.g., a centrifuge), a blood draw line with a pump, and an anticoagulant line.
• EP0654277A1 (Blood component collection system with optimizer): This reference teaches a blood component collection system featuring an "optimizer." An "optimizer" in this context implies a controller capable of managing collection parameters and performing calculations to achieve improved or specific collection outcomes. This provides the framework for a controller to perform more sophisticated calculations beyond simple volume measurement.
• US5470483A (Device and method for controlling the balance of fluids in an extracorporeal blood circuit): As with Claim 1, this reference teaches the necessary sensors and control mechanisms within an apheresis system for monitoring fluid volumes, including the volume of plasma collected (e.g., via a weight sensor) and the volume/ratio of anticoagulant added (e.g., by monitoring pump rotations or the weight of the anticoagulant source).
• General Knowledge/Other Prior Art for Hematocrit Determination: As discussed previously, the means and methods for determining donor hematocrit (e.g., pre-procedure testing or in-line optical sensors) were well-known in the art.

Motivation to Combine: A PHOSITA would be motivated to integrate a conventional plasmapheresis system (US4713176A) with an advanced control system or "optimizer" (EP0654277A1) that incorporates comprehensive fluid monitoring (US5470483A) and known hematocrit data. The problem of inconsistent pure plasma collection volumes due to anticoagulant dilution and varying donor hematocrit is a persistent challenge in the field, further exacerbated by regulatory requirements for specific pure plasma volumes. Therefore, it would be obvious to configure the "optimizer" or controller to perform the explicit calculation of pure plasma volume based on the available input data (collected plasma volume, anticoagulant ratio, and donor hematocrit). This combination would yield a system that addresses a known problem by implementing a straightforward computational solution using existing measurement capabilities.

Claim 24 (System for collecting plasma with prospective calculation)

Claim 24 requires:
A system comprising: a venous-access device; a blood component separation device; a blood draw line with a blood draw pump; an anticoagulant line fluidly coupled to an anticoagulant source; and a controller configured to control operations and calculate a volume of pure plasma to be collected based on a volume of plasma component to be collected, a ratio of anticoagulant to be added, and a hematocrit of the subject.

Combination of Prior Art: US4713176A in view of EP0654277A1, US5470483A, JPH0252665A, and general knowledge regarding hematocrit measurement.

• US4713176A (Plasmapheresis system and method): Provides the foundational plasmapheresis system components.
• EP0654277A1 (Blood component collection system with optimizer): An "optimizer" in a blood collection system would inherently involve setting targets and planning collection based on desired outcomes and initial parameters. To "optimize" collection, a controller would logically be configured to calculate how much pure plasma should be collected, effectively making a prospective calculation.
• US5470483A (Device and method for controlling the balance of fluids in an extracorporeal blood circuit): This reference provides the mechanisms for monitoring fluid volumes and ratios within the system, which are essential for informing both retrospective and prospective calculations by a controller.
• JPH0252665A (Blood plasma taking device and control method thereof): This patent explicitly refers to a "control method thereof" for a blood plasma taking device. Control methods in such systems often involve predictive or planning algorithms to optimize efficiency or meet specific targets.
• General Knowledge/Other Prior Art for Hematocrit Determination: As before, the determination of donor hematocrit is standard. US12324873 itself describes determining the donor's weight and hematocrit as initial steps (Steps 410 and 415 in FIG. 4) before commencing blood processing, indicating these parameters are known for planning purposes.

Motivation to Combine: The motivation to combine these references for Claim 24 builds upon the motivation for Claim 13, with an emphasis on predictive control and planning. A PHOSITA, recognizing the need to comply with pure plasma volume regulations and to standardize collection outcomes, would find it obvious to equip an apheresis system's controller (such as one with an "optimizer" from EP0654277A1) with the ability to prospectively calculate the target volume of pure plasma. This prospective calculation would utilize pre-determined donor parameters (like hematocrit, which is taken before the procedure starts) and the planned ratio of anticoagulant to be added. Given that the underlying physiological principles and measurement techniques for individual components (total volume, anticoagulant, hematocrit) are known, implementing a control algorithm that performs these calculations to predict and achieve a desired pure plasma yield would be a predictable and obvious improvement for a PHOSITA in the field.

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

The patent term for utility patents filed on or after June 8, 1995, is generally 20 years from the earliest filing date of the application from which benefit is claimed. This 20-year term can be adjusted by Patent Term Adjustment (PTA) or Patent Term Extension (PTE).

• Patent Term Adjustment (PTA): PTA compensates for certain administrative delays by the USPTO during the patent prosecution process, such as delays in issuing office actions, responding to applicant replies, or issuing the patent after the issue fee is paid. The USPTO does not calculate the exact expiration dates or PTA publicly but provides a downloadable calculator for estimation. To determine the precise PTA for US12324873, detailed prosecution history would need to be retrieved from USPTO Patent Center.
• Patent Term Extension (PTE): PTE is primarily granted for delays due to regulatory review periods, most commonly for pharmaceuticals and medical devices requiring FDA approval. There is no information in the provided patent text to indicate if US12324873 has been granted any PTE.

Continuation Applications

US Patent 12324873 is itself a continuation of earlier applications. The "Priority" section of the patent details its lineage:

• This patent application (US18/955,269, which matured into US12324873B2) is a continuation of U.S. application Ser. No. 17/205,374, filed March 18, 2021.
• U.S. application Ser. No. 17/205,374 is a continuation of U.S. application Ser. No. 16/866,078, filed May 4, 2020 (now U.S. Pat. No. 10,980,926).
• U.S. application Ser. No. 16/866,078 is a continuation of U.S. application Ser. No. 15/608,183, filed May 30, 2017 (now U.S. Pat. No. 10,758,652).

A continuation application claims priority to a parent application and typically pursues additional claims based on the same disclosure.

Divisional Applications

Based on the provided patent text, there are no explicitly identified "divisional applications" for US12324873. A divisional application is filed when an examiner issues a restriction requirement, separating claims to distinct inventions.

Related Family Members

The patent family of US12324873, as provided in the "Family Applications" section of the patent document, includes the following U.S. applications, all claiming the same priority date of 2017-05-30:

• US15/608,183 (Active, issued as US10758652B2)
• US16/866,078 (Active, issued as US10980926B2)
• US17/205,374 (Active, issued as US12171916B2)
• US17/943,410 (Active, issued as US11738124B2)
• US18/955,269 (Active, issued as US12324873B2 - the patent in question)
• US19/202,281 (Pending, published as US20250269097A1)

These applications represent a continuous chain of priority claims, all stemming from the earliest application, US15/608,183, filed on May 30, 2017.

Projected Expiration Date

The term of a U.S. utility patent issued from an application filed on or after June 8, 1995, is generally 20 years from the filing date of the earliest application for which a benefit is claimed.

For US12324873, the earliest priority date is 2017-05-30 (from U.S. application Ser. No. 15/608,183).

Therefore, the base patent term would extend 20 years from this date.

2017-05-30 + 20 years = 2037-05-30.

This date is explicitly stated as the "Anticipated expiration" date in the Google Patents legal status section.

This projected expiration date is subject to any Patent Term Adjustments (PTA) for USPTO delays during prosecution or Patent Term Extensions (PTE) for regulatory delays, neither of which are fully quantifiable from the provided patent text alone. However, the legal status information confirms an "Anticipated expiration" of 2037-05-30.