Patent 12377204
Prior art
Earlier patents, publications, and products that may anticipate or render the claims unpatentable.
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Prior art
Earlier patents, publications, and products that may anticipate or render the claims unpatentable.
Based on the information available for US patent 12,377,204 and its family, a review of the most relevant prior art has been conducted. The provided text for patent 12,377,204 does not itself contain a "References Cited" section. Therefore, this analysis identifies the most relevant prior art by examining the prosecution history of its direct parent and grandparent patents in the same family, as these references were likely considered during the examination of the '204 patent itself.
The following prior art references are considered highly relevant to the claims of US patent 12,377,204.
Analysis of Key Prior Art
1. US Patent 5,728,058 A (Re-issued as RE39,486 E1)
- Full Citation: US Patent 5,728,058 A, "Method and apparatus for controlling the volume of collected plasma", Re-issued as RE39,486 E1.
- Assignee: Baxter International Inc.
- Filing Date: June 7, 1995
- Issue Date: March 17, 1998
- Brief Description: This patent describes a plasmapheresis system that estimates the volume of plasma collected from a donor. It calculates the amount of plasma in the collection container by weighing the container and subtracting the calculated weight of the anticoagulant. Crucially, it determines the amount of anticoagulant in the bag by relating it to the amount of whole blood processed, using a fixed, predetermined ratio of anticoagulant to whole blood. It also discloses stopping the collection based on a target collection volume.
- Potential Anticipation of Claims in US 12,377,204:
- Method Claim: The '058 patent appears to anticipate the core steps of the method claim in patent 12,377,204. It teaches calculating a volume of plasma in a collection container by accounting for the volume of anticoagulant mixed with it. The '204 patent's key distinguishing feature is its use of the donor's real-time or pre-determined hematocrit to calculate the percentage of anticoagulant in the collected plasma more accurately, rather than relying on a fixed ratio. However, an argument for obviousness could be strong, as hematocrit's effect on plasma/anticoagulant ratios was known in the art. The '058 patent does not, however, calculate a donor-specific target volume based on height, weight, and a target percentage of total plasma volume.
- System Claim: The '058 patent describes a system with similar hardware: pumps, a blood separator, a collection container, and a controller. The controller in the '058 patent is programmed to perform the plasma volume calculation. This anticipates the basic structure of the system claim in the '204 patent. The novelty of the '204 system claim lies in the specific programming of its controller to use donor-specific physiological data (height, weight, hematocrit) to set a personalized collection target.
2. US Patent 6,419,643 B1
- Full Citation: US Patent 6,419,643 B1, "Apheresis system with donor data card".
- Assignee: Gambro, Inc.
- Filing Date: October 26, 2000
- Issue Date: July 16, 2002
- Brief Description: This patent discloses an apheresis system that uses a donor data card to automatically load donor-specific information, including height, weight, and hematocrit, into the machine. The system uses this data to set procedure parameters and collection targets. The goal is to automate the setup process and reduce manual entry errors, while also tailoring the procedure to the specific donor.
- Potential Anticipation of Claims in US 12,377,204:
- Method Claim: The '643 patent teaches determining a donor's weight, height, and hematocrit and using that information to set collection parameters. This directly addresses the initial steps of the '204 patent's method claim. It anticipates the concept of personalizing a collection procedure based on these specific donor metrics. However, the '643 patent does not explicitly describe the further step of calculating the volume of pure plasma by subtracting a dynamically calculated anticoagulant volume based on hematocrit in real-time.
- System Claim: This patent describes a system with a controller that receives donor-specific data (height, weight, hematocrit) to establish a collection target. This anticipates the elements of the '204 system claim related to using donor physiological data to control the collection process. The '204 patent's potential novelty over this reference would again hinge on the specific calculation and use of a pure plasma volume, as opposed to simply setting a total product volume based on donor data.
3. US Patent 7,052,482 B2
- Full Citation: US Patent 7,052,482 B2, "Method for improved plasma collection".
- Assignee: Haemonetics Corporation (the same assignee as the '204 patent).
- Filing Date: April 30, 2003
- Issue Date: May 30, 2006
- Brief Description: This patent describes a method for optimizing plasma yield by considering the donor's hematocrit. It discloses adjusting the ratio of anticoagulant to whole blood based on the donor's hematocrit to improve efficiency and avoid excess anticoagulant use. It teaches that the amount of anticoagulant needed is dependent on the plasma portion of the whole blood, which is determined by hematocrit.
- Potential Anticipation of Claims in US 12,377,204:
- Method Claim: This patent establishes a clear link in the prior art between donor hematocrit and the relative proportions of plasma and anticoagulant in an apheresis procedure. It explicitly teaches the importance of using hematocrit to manage the process. While it focuses on adjusting the inlet anticoagulant ratio rather than calculating the outlet pure plasma volume, it discloses the underlying technical principle. This reference makes the step of using hematocrit to calculate the anticoagulant percentage in the final product (as claimed in the '204 patent) potentially obvious under 35 U.S.C. § 103, if not directly anticipated. It does not, however, combine this with calculating a target volume based on the donor's total plasma volume derived from height and weight.
- System Claim: The system described would be functionally similar to that in the '204 patent, including a controller that uses hematocrit data to manage the procedure. The specific algorithm for calculating pure plasma volume in the final collection bag is the key differentiator.
Disclaimer: As of the date of this analysis, no records for US patent 12377204 were found in the public USPTO databases. The information presented here is based on the provided text and analysis of prior art cited against its known parent patents.
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