Prior art

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.

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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.

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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.

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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.