Prior art

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

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

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

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

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

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

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

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

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

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

5. Japanese Patent Application Publication JPH0252665A

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

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Conclusion:

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