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 .
Status of the Claims
Claims filed 09/11/2024 has been entered. Claims 15-21 are pending and under consideration.
Claim Objections
Claims 1, 18 and 20 are objected to because of the following informalities:
Claim 1 line 14 recites “a donor” which should read “the donor”
Claim 1 line 16 recites “said flow controller” which should read “a flow controller”
Claim 1 line 19 recites “a replacement fluid container” which should read “said replacement fluid container”
Claim 18 lines 1-2 recites “said flow path of said primary container line” which should read “said primary container line”
Claim 20 line 2 recites “the volume of replacement fluid” which should read “the volume of the replacement fluid”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Nevens (US 4407660 A) in view of Djerassi (US 4111199 A).
Regarding claim 15, Nevens substantially teaches applicant’s claimed invention, and specifically discloses a method of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
A method for maintaining fluid volume in a donor during a manual collection of whole blood with a disposable fluid circuit (figure 4) comprising a primary container (figure 6 and col 9 line 24-36, first container 44 is configured to collect and process whole blood) for collecting and processing whole blood and one or more secondary containers (figure 6, second container 42 is in openable flow communication with the first container 44 through manifold 10) downstream of and in openable flow communication with said primary container;
a donor access device (figure 6 and col 9 lines 10-23, phlebotomy needle 58 and primary tubing 52 define a flow path) and a donor access line defining a flow path in flow communication with said donor access device;
a replacement fluid container (figure 7 col 10 lines 15-27, saline solution container 90 contains saline or other IV) containing a replacement fluid; and
a branch member (figures 2-3, manifold 10) in flow communication with said donor access line (cl 9 lines 10-23, main passage 12 of the manifold 10 is in fluid communication with the primary tubing 52), said branch member including a first branch (figures 2-3, branch between open end 14 and branch passage 18 in fluid communication with the first container 14 through auxiliary tubing 62) in openable flow communication with said primary container through a primary container line (figures 2-3, auxiliary tubing 62) and a second branch (figures 2-3, a branch between the open ends 14 and 16 in fluid communication with the saline solution container 90 through tubing set 70) in openable flow communication with said replacement fluid container by a replacement fluid line (figure 7, tubing set 70 at least including tubing lines 84 and 76), said method comprising:
withdrawing blood from the donor through the donor access device and collecting a selected volume of said blood in said primary container (col 9 lines 10-36, collecting a unit of a whole blood from donor in the first container 44);
closing the primary container line by actuating a flow controller on said primary container line (col 9 lines 10-36, after the collection, tubing 62 is sealed and closed by seal clips 63);
opening the replacement fluid line (figure 7 and col 9 lines 10-45, after the collection of the whole blood and during processing the blood, clamps 77 and 85 are opened tubing lines 84 and 76 provide saline to donor); and
delivering a selected volume of replacement fluid from said replacement fluid container through said replacement fluid line to said donor through said access device (figure 7 and figure 7 and col 9 lines 10-45, a selected volume of replacement of saline, volume of the container 90 at the most, contained within the solution container 90 delivered to the donor).
Nevens does not teach the one or more second containers are located downstream of the primary container; though
Nevens teaches the secondary container and the primary container are arranged in parallel (figure 2)
In the same field of endeavor, namely a method of collecting a whole blood from a donor, Djerassi teaches the one or more second containers (figure 1, satellite bag 20 is located downstream of the bag 16) are located downstream of the primary container.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nevens to incorporate the teachings of Djerassi and provides the secondary container as claimed for the purpose of facilitating collection and processing of whole blood into blood components, e.g., red blood cells, plasma and platelets as taught by Djerassi (col 4 lines 20-60), foe example such configuration enables directing separated blood component from the primary container into secondary container, and the blood component directly infused to patient.
Regarding claim 17, Nevens, as modified by Djerassi, teaches the method of claim 15.
The combination further teaches comprising delivering said replacement fluid to said donor after arriving at said selected volume and said blood collection is collected (Neveen ;figure 7 and col 9 line 24-45, saline solution is delivered after a unit of whole blood has been collected in the first container 44)
Regarding claim 18, Nevens, as modified by Djerassi, teaches the method of claim 17.
The combination further teaches further comprising permanently sealing said flow path of said primary container line (Neveen; figure 7 and col 9 lines 24-45, after a unit of whole blood has been collected, the first auxiliary tubing 62 is sealed and severed).
Regarding claim 19, Nevens, as modified by Djerassi, teaches the method of claim 15.
The combination further teaches comprising controlling the flow of said replacement fluid to said donor (Nevens; col 10 line 16-27, controlling flow of saline by controlling roller clamps 77 and 85)
Claim 16 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Nevens (US 4407660 A) in view of Djerassi (US 4111199 A), and in further view of Utterberg (US 20020151834 A1).
Regarding claim 16, Nevens, as modified by Djerassi, teaches the method of claim 15.
The combination does not expressly teach comprising delivering the replacement fluid to said donor prior to arriving at said selected volume of blood collected in said primary container.
In the same field of endeavor, namely blood set priming method and apparatus, Utterberg teaches delivering the replacement fluid to said donor prior to arriving at said selected volume of blood collected in said primary container ([0003] infusing saline solution during and before end of procedure).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nevens, as modified by Djerassi, to incorporate the teachings of Utterberg and provide the method as claimed for the purpose of preventing symptoms from rapid blood loss, e.g., hypotension, as taught by Utterberg ([0003]).
Regarding claim 21, Nevens, as modified by Djerassi, teaches the method of claim 15.
The combination further teaches comprising pausing said withdrawing of said blood from the donor prior to opening said replacement fluid line (Nevens; figure 7 col 9 lines 24-34 and 10 lines 45-55, blood collection paused prior to opening said tubing lines 76 and 84).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Nevens (US 4407660 A) in view of Djerassi (US 4111199 A), and in further view of Loubser (US 5658271 A).
Regarding claim 20, Nevens, as modified by Djerassi, teaches the method of claim 15.
The combination does not teach comprising determining the volume of replacement fluid to be delivered to said donor.
In the same field of endeavor, namely an apparatus for sequestration of blood from a patient, Loubser teaches determining the volume of replacement fluid to be delivered to said donor (col 14 lines 50-65, administering 3ml crystalloid every 1ml of blood sequestered, 3ml).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nevens, as modified by Djerassi, to incorporate the teachings of Loubser and provides the method as claimed for the purpose of preventing symptoms from rapid blood loss, e.g., hypotension, as taught by (col 14 lines 50-57).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pierce et al (US 20020062100 A1) and Patel et al (US 20160089486 A1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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/SETH HAN/ Examiner, Art Unit 3781
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