Prior art — US Patent 10980934

As a senior US patent analyst, I have reviewed the prior art cited during the prosecution of US Patent 10,980,934 ('934 patent). The following analysis details the most relevant references and their potential to anticipate the patent's claims under 35 U.S.C. § 102.

An anticipation requires that a single prior art reference discloses, either expressly or inherently, each and every element of a claimed invention. The key inventive concepts of the '934 patent revolve around personalizing plasma collection by: 1) calculating a donor's specific plasma volume using height, weight, and hematocrit; 2) setting a target collection volume as a percentage of that total volume; 3) calculating the volume of pure plasma by accounting for anticoagulant; and 4) managing fluid balance to a target intravascular deficit.

Analysis of Most Relevant Cited Prior Art

Based on a review of the 38 U.S. patents and applications cited by the examiner, the following references are the most relevant to the core claims of the '934 patent.

1. U.S. Patent No. 9,993,588 B2 ("Wegener")

Full Citation: US 9,993,588 B2, "Method and a device for the treatment of blood," assigned to Fresenius Medical Care Deutschland GmbH.
Dates: Filed: July 2, 2013; Published: June 12, 2018.
Brief Description: Wegener describes a method for controlling a blood treatment device, such as for plasmapheresis. The system uses patient-specific data, including hematocrit, to optimize the procedure. A key feature is the calculation of the patient's blood volume and plasma volume to determine a maximum plasma volume that can be safely removed. The system monitors the amount of anticoagulant and the total volume of fluid collected to control the process.
Potential Anticipation of Claims: Wegener is highly relevant and potentially anticipates several elements of the '934 patent's independent claims.
- Claim 1 (Method):
  - determining the weight, height, and hematocrit of a donor: Wegener explicitly teaches using patient data, including hematocrit, to calculate blood parameters (Abstract; Col. 4, lines 5-15). While not explicitly listing height and weight in every embodiment, these are standard inputs for the blood volume calculations it incorporates.
  - calculating a donor plasma volume: Wegener directly discloses calculating the patient's plasma volume based on their total blood volume and hematocrit (Col. 4, lines 12-15).
  - calculating a target plasma collection volume: Wegener teaches determining a "maximum plasma volume to be removed" based on the calculated patient plasma volume (Col. 4, lines 20-25). This aligns with setting a target volume.
  - calculating a volume of pure plasma collected: The Wegener system monitors the amount of anticoagulant and the total volume of product collected, which are the necessary inputs for calculating the pure plasma volume. It discusses controlling the ratio of anticoagulant to blood, implicitly requiring knowledge of the volumes of both.
- Conclusion: Wegener teaches calculating a donor-specific plasma volume and using it to set a collection target. While it may not use the exact phrase "target intravascular deficit" or specify the target as a percentage, the underlying method is substantially the same. A strong argument for anticipation of the core process steps exists, particularly for claims 1, 9, and 17.

2. U.S. Patent Application Pub. No. 2014/0039373 A1 ("Ragusa '373")

Full Citation: US 2014/0039373 A1, "System and Method for Tailoring the Volume of Plasma Collected," invented by Michael Ragusa (the same inventor as the '934 patent), assigned to Haemonetics Corporation.
Dates: Filed: August 2, 2012; Published: February 6, 2014.
Brief Description: This earlier application by the same inventor and assignee lays the groundwork for the '934 patent. It discloses a method for tailoring the volume of plasma collected based on a donor's specific physiological characteristics, including hematocrit and total blood volume. It aims to collect a "therapeutically effective and safe" amount of plasma, moving beyond simple weight-based charts. It also discusses managing net fluid loss by administering a replacement fluid like saline.
Potential Anticipation of Claims: As a foundational document from the same inventor, Ragusa '373 comes very close to anticipating the '934 patent's claims.
- Claim 1 (Method):
  - determining...hematocrit of a donor: Ragusa '373 explicitly uses the donor's hematocrit as a key input (Abstract; Para.).
  - calculating a donor plasma volume: The application describes calculating the donor's total blood volume and using the hematocrit to determine plasma volume (Para.).
  - calculating a target plasma collection volume: It teaches determining a "customized target collection volume" based on these donor-specific parameters (Para.,).
  - returning...a volume of saline: Ragusa '373 describes administering replacement fluid to control the "net loss of fluid," which is the same concept as managing the intravascular deficit (Para.).
- Conclusion: Ragusa '373 discloses nearly all elements of the independent claims. The primary distinction may lie in the '934 patent's more explicit recital of calculating the "pure plasma" volume by subtracting anticoagulant and setting the target as a specific percentage of the total plasma volume. However, the core inventive concept of a donor-customized plasma collection target based on hematocrit and blood volume is clearly present in this prior art reference. It is a very strong reference for an obviousness argument and borders on anticipation.

3. U.S. Patent No. 8,690,816 B2 ("Dolecek")

Full Citation: US 8,690,816 B2, "Apheresis system with variable volume replacement fluid," assigned to Terumo BCT, Inc.
Dates: Filed: May 20, 2008; Published: April 8, 2014.
Brief Description: Dolecek describes an apheresis system that automatically adjusts the amount of replacement fluid (saline) returned to a donor. The system determines a target net fluid loss for the donor at the end of the procedure (e.g., zero or another desired value) and then calculates the amount of saline needed to achieve this target, accounting for the volume of plasma and anticoagulant removed. The system monitors the weights of the collected plasma, anticoagulant, and saline bags to perform these calculations in real-time.
Potential Anticipation of Claims: Dolecek provides a strong disclosure for the fluid management aspects of the '934 patent's claims.
- Claim 1 & 17 (Method):
  - calculating an intravascular deficit: This is synonymous with Dolecek's concept of calculating and controlling the "net fluid loss" for the donor (Abstract; Col. 2, lines 35-45).
  - returning a volume of saline...to obtain a target intravascular deficit: This is the central teaching of Dolecek. It describes calculating the precise volume of saline needed to achieve a pre-determined end-of-procedure fluid balance for the donor (Col. 7, lines 15-30).
- Conclusion: Dolecek directly teaches the concept of managing fluid balance to a specific, predetermined target by calculating net fluid loss and administering a corresponding volume of saline. While it does not explicitly describe personalizing the plasma collection target based on the donor's total plasma volume, it anticipates the limitations in claims 1, 9, and 17 related to calculating and achieving a "target intravascular deficit." This makes it a highly relevant reference that could anticipate a key aspect of the claimed invention.