Prior art

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.