DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0353841 to Patel et al.
In the specification and figures, Patel discloses the apparatus substantially as claimed by Applicant. With regard to claim 20, Patel discloses an automated system for separating plasma from whole blood comprising a separator for separating whole blood into a plasma fraction and a concentrated cell fraction, a reusable hardware component comprising a touch screen for receiving input from an operator and configured to provide, based on operator input, a calculation of the volume of anticoagulant needed for the procedure (see ¶0093, 0080).
Allowable Subject Matter
Claims 1-19 are allowed.
Claims 21 and 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: With regard to claims 1-19 and 21-22, US 2021/0353841 to Patel discloses a method for collecting plasma comprising the steps of determining a total blood volume for a donor, determining a volume of raw plasma that may be collected, determining a volume of anticoagulant to be added to the plasma, determining the volume of plasma product to be collected, wherein the plasma product comprises the raw plasma plus anticoagulant (see ¶0080).
Patel does not disclose calculating a volume of anticoagulant to be returned to the donor based on a separation efficiency for the blood separator, calculating a total volume of anticoagulant to be used, and preparing containers.
US 2013/0267884 to Boggs et al discloses a step of estimating the volume of anticoagulant returned to the patient and making all calculations before donor connection, but does not use a separation efficiency of the blood separator to make that calculation.
US 2018/0344921 to Ragusa discloses calculating collection targets based on donor information, and making all calculations before the donor is connected to an extracorporeal circuit, but does not disclose using a separation efficiency of the blood separator to make calculations.
Accordingly, the prior art fails to disclose or suggest the combination of steps for blood separation as claimed by Applicant.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2012/0053501 Brown
Methods for anticoagulating blood
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 5 November 2025