Obviousness

Obviousness Analysis of US Patent 10,980,926

This analysis evaluates the obviousness of the independent claims of US Patent 10,980,926 (the "'926 patent") under 35 U.S.C. § 103. The analysis is based on prior art references cited by the patent itself. The priority date of the '926 patent is May 30, 2017.

A claim is considered obvious if the differences between the claimed invention and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art (PHOSITA). A PHOSITA in this field would likely be an individual with a degree in biomedical or mechanical engineering and several years of experience in the design and operation of apheresis systems.

The central concept of the '926 patent is to use a donor's weight and hematocrit to pre-calculate a target collection volume that accounts for both the desired amount of pure plasma and the co-collected anticoagulant, thereby ensuring a more precise and standardized volume of pure plasma is collected from every donor.

Prior Art Combination

The independent claims of the '926 patent are rendered obvious by the combination of:

• EP0654277A1 to Brown et al. ("Cobe"), assigned to Cobe Laboratories, Inc., with a priority date of October 21, 1993.
• US5494592A to Kell et al. ("Haemonetics '592"), assigned to Haemonetics Corporation, with a filing date of April 27, 1993.

Analysis of Independent Claim 1 (Method Claim)

Claim 1 details a method for collecting plasma. The key steps involve: (a-b) determining donor weight and hematocrit; (d) calculating a target volume of pure plasma based on weight; (c) calculating the volume of anticoagulant to be collected based on hematocrit; (e) determining a final target collection volume from the sum of the pure plasma and anticoagulant volumes; and (f-j) performing the apheresis procedure until this final target volume is met.

1. Cobe (EP0654277A1) discloses a "blood component collection system with optimizer." The system includes a controller that utilizes various donor-specific data points to optimize the collection procedure. Crucially, Cobe teaches using "donor data such as donor height, weight, sex, and hematocrit to calculate an optimum collection time or volume" (Column 3, lines 17-21). The stated goal is to "obtain the desired quantity and/or quality of component in the minimum time" (Column 3, lines 29-32). This reference explicitly teaches the foundational steps of using a donor's weight and hematocrit as inputs to a controller to determine a target collection volume for a desired quantity of a blood component like plasma.

2. Haemonetics '592 (US5494592A) discloses an apheresis system where the controller is "programmed with the desired volume of plasma to be collected from the donor." It further clarifies that this volume "is a function of the donor's weight and is regulated by the FDA" (Column 14, lines 52-57). This reference establishes the common and well-understood practice of determining the target amount of plasma based on donor weight to comply with safety regulations.

Motivation to Combine and Obviousness of Claim 1:

A PHOSITA starting with the "optimizer" system described in Cobe would be motivated to achieve the goal of collecting a "desired quantity" of plasma with high precision. Haemonetics '592 confirms that this "desired quantity" is determined by donor weight. The PHOSITA would have been well aware that the fluid collected in the final container is a mixture of plasma and anticoagulant, and that the ratio of these two components for a given volume of processed blood is a direct function of the donor's hematocrit.

Cobe's system already uses hematocrit to calculate an "optimum collection... volume." A PHOSITA would have understood that the most direct way to implement this optimization to yield a precise amount of pure plasma would be to account for the diluting volume of the co-collected anticoagulant. This involves a straightforward calculation:

1. Determine the target pure plasma volume from the donor's weight (taught by Haemonetics '592 and standard practice).
2. Use the donor's hematocrit and the known anticoagulant ratio of the machine to calculate the volume of anticoagulant that will necessarily be collected along with the target plasma volume.
3. Sum these two volumes to arrive at a total collection volume.

This calculation is not an inventive step but rather the predictable and logical implementation of Cobe's teaching. It represents a simple application of mass balance principles that would have been obvious to a PHOSITA seeking to precisely control the yield of the final product. Therefore, all steps of Claim 1 would have been obvious over the combination of Cobe and Haemonetics '592.

Analysis of Independent Claim 8 (System Claim)

Claim 8 recites a system comprising standard apheresis components and a controller configured to perform the calculations described in Claim 1.

Both Cobe and Haemonetics '592 disclose apheresis systems with controllers that receive donor data, perform calculations, and control the collection process. Cobe's controller is explicitly configured to "utilize various donor data such as... weight, and hematocrit to calculate an optimum collection... volume."

As the method of Claim 1 is obvious over the prior art, implementing this method on a conventional controller would also be obvious. Configuring the controller from Cobe to perform the specific, but obvious, calculations (Target Pure Plasma + Calculated Anticoagulant = Final Target Volume) would be a matter of routine programming for a PHOSITA, not an inventive act. Therefore, the system of Claim 8 would have been obvious.

Analysis of Independent Claim 15 (Method of Programming)

Claim 15 recites a method for programming the device by receiving donor weight and hematocrit into a control system and using these inputs to calculate and set a "blood processing end point" based on the target collection volume.

This claim merely describes the setup and programming steps that are inherent to the method of Claim 1 and the operation of the system in Claim 8. Cobe explicitly discloses a "donor data input means... for inputting donor data such as the donor's... weight... and hematocrit" (Column 5, lines 34-37), which is then used by the control system. Calculating a target volume to serve as the endpoint of the procedure is the explicit purpose of Cobe's controller. Therefore, the programming method of Claim 15 is also obvious for the same reasons that claims 1 and 8 are obvious.

Conclusion

The independent claims of US Patent 10,980,926 would have been obvious to a person of ordinary skill in the art at the time of the invention. The prior art, particularly Cobe (EP0654277A1), already taught the core concept of using a donor's weight and hematocrit in a controller to optimize the collection volume for a desired quantity of plasma. Combining this with the established practice taught in Haemonetics '592 (US5494592A) of basing the plasma target on donor weight would have motivated a PHOSITA to perform the simple and predictable calculations necessary to account for anticoagulant volume, thus arriving at the claimed invention without an inventive step.