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 .
Information Disclosure Statement
The information disclosure statement(s) (IDSs) submitted on 12/4/23 and 7/15/24 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner, but where the documents in the IDS(s) will be considered in the same manner as other documents in Office search files while conducting a search of the prior art in a proper field of search.
Status of the Claims
Claims 1-21 are pending in the application, with claims 1-14 under consideration and claims 15-21 withdrawn.
Election/Restriction
Applicant's election of Group I claims 1-14 in the 2/23/26 Response to Restriction Requirement is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse MPEP 818.01(a), 37 CFR 1.111. The requirement is deemed proper and is therefore made FINAL. Group II Claims 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. A complete reply to a final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraph of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kusters (US 2022/0212128 A1)(as prior publication with publication date of 7/7/22 before effective filing date of 11/15/22).
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As to independent claims 1 and 8, Kusters teaches [claim 8] a blood processing system (Abstract; Fig.1-2;[0010]-[0190], claims 11-20), comprising: a (reusable) blood processing device 10 , comprising/including: a pump system P1-P6 (pumps P1-P6 Fig.2; [0059], [0071]; [0078]); a centrifuge 16 (centrifugal separator 16 Fig.1; [0081]-[0099]); and a controller 18 (controller 18 to govern operation of other components of blood processing and collection procedure Fig.1 [0044],ll.10-13; [0054],ll.10-19; [0065]-[0072]);
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[claim 8] a disposable ([0073],ll.1-2) fluid flow circuit 12 (Fig.2;[0044],ll.12-13) including: a processing chamber 36 (centrifugal separation chamber 36 as part of circuit 12; Fig.1; [0051],ll.5-6) received by the centrifuge 16 (centrifugal separation chamber 36 received by centrifuge 16 in centrifuge compartment 32 and spun or rotated about axis 38 driven by electric drive motor or rotor 40; Fig.1-2; [0051]; [0081]-[0099]), a buffy coat or white blood cell (WPC) layer collection container F5 (MNC collection container F5; [0139],ll.10,1-10) (WPC layer containing mononuclear cells (MNCs, where MNCs are part of the buffy coat or WBC layer [0081],ll.2-3) separated in processing/separation chamber 36 between plasma and RBC layers via centrifugation [0134],ll.3-8); and a plurality of conduits (as lines L1-L14; e.g., L10 for WBC [0139]; L1, L4 for blood fed into centrifugal separation chamber 36; [0127],ll.7-9) fluidly connecting the components of the fluid flow circuit 12 ([0124]),
[claims 1 and 8]
wherein the controller is configured to ([0065]-[0072]): actuate the pump system P1-P6 to convey blood from a blood source ([0127],ll.1-2; [0126]) into the centrifugal/processing chamber 36 ([0127],ll.7-9), actuate the centrifuge 16 to separate the blood in the processing chamber/ centrifuge 36 ([0071],ll.11-14) into plasma, red blood cells, and a buffy coat or white blood cell layer between the separated plasma and the separated red blood cells ([0014],ll.1-4; claim 11,ll.3-5),
actuate the pump system P1-P6 to convey the separated plasma and the separated red blood cells out of the centrifuge/processing chamber 36 for collection ([0071],ll.14-17), and
actuate the pump system P1-P6 to convey a portion of the collected plasma into the centrifuge/processing chamber 36 to convey the buffy coat or white blood cell layer (MNC layer) out of the centrifuge/processing chamber 36 for collection [claim 8] and into the buffy coat or white blood cell collection container F5 (claim 15 of Kusters).
As to claims 2 and 9, Kusters teaches wherein the controller 18 is configured to continue actuating the pump system P1-P6 (pumps P1-P6 Fig.2; [0059], [0071]; [0078]) to convey said portion of the collected plasma into the centrifuge 16 until a predetermined volume of fluid has been displaced from the centrifuge 16 ([0132],ll.7-12).
As to claims 3 and 10, Kusters teaches wherein: the blood processing device further comprises an optical sensor M2 (centrifugal separator sensor M1) configured to monitor fluid exiting the centrifuge/processing chamber 36 (of 16) (determining one or more properties of fluids flowing out of centrifugal separator 16 [0060]-[0061]); the controller 18 is configured to continue actuating the pump system P1-P6 [0059] to convey said portion of the collected plasma into the centrifuge/processing chamber ([0132],ll.7-12) until the optical sensor detects ([0060],ll.7-11,15-20) a non-buffy coat or white blood cell layer fluid exiting the centrifuge ([0139]).
As to claims 4-5 and 11-12, Kusters teaches wherein the controller 18 is configured to actuate the pump system P1-P6 (pumps P1-P6 Fig.2; [0059], [0071]; [0078]) to simultaneously ([0067]): convey a first and second portion of the separated red blood cells out of the centrifuge/processing chamber ([0071],ll.14-17) and into a buffy coat or white blood cell layer collection (MNC) container F5 (claim 15 of Kusters; controller 18 controlling WBC/MNC collection [0066],ll.12, 1-14; [0067],ll.8-13; where any part of processes can be repeated or continued [(0148)]), and convey a first and second portion of the separated plasma out of the centrifuge/processing chamber 36 and into a plasma collection container [claim 8] of the flow circuit 12 (controller 18 controlling plasma collection into collection container [0066],ll.14, 1-14; [0067],ll.8-13; where any part of processes can be repeated or continued [(0148)]).
As to claims 6 and 13, Kusters teaches wherein the controller 18 is configured to ([0067]) actuate the pump system P1-P6 (pumps P1-P6 Fig.2; [0059], [0071]; [0078]) to convey said first portion of the separated red blood cells out of the buffy coat or white blood cell layer collection container and into the centrifuge/processing chamber 36 so as to convey a third portion of the separated plasma into the plasma collection container (controller 18 controlling plasma collection into plasma collection container [0066],ll.14, 1-14; [0067],ll.8-13; where any part of processes can be repeated or continued [(0148)]).
As to claims 7 and 14, Kusters teaches wherein: [claim 7] the blood processing device is configured for use in combination with a fluid flow circuit 12 including the plasma collection container (as presented above for claim 8; e.g., [0124]),
the controller 18 is configured to actuate the pump system P1-P6 (pumps P1-P6 Fig.2; [0059], [0071]; [0078]) to convey air in the fluid flow circuit into the plasma collection container plasma collection into plasma collection container [0066],ll.14, 1-14; [0067],ll.8-13 prior to actuating the centrifuge 18 to separate the blood in the centrifuge/processing chamber 36 ([0125],ll.12-18) , the controller 18 is configured to actuate the pump system P1-P6 (pumps P1-P6 Fig.2; [0059], [0071]; [0078]) to convey at least a portion of the air in the plasma collection container into the centrifuge /processing chamber to convey a third portion of the separated red blood cells out of the centrifuge/processing chamber 26 for collection ([0071],ll.14-17), and
the controller 18 is configured to actuate the pump system P1-P6 (pumps P1-P6 Fig.2; [0059], [0071]; [0078]) to convey said portion of the collected plasma from the plasma collection container into the centrifuge/processing chamber to convey the buffy coat or white blood cell (MNC) layer out of the centrifuge/processing chamber 36 for collection in the buffy coat or white blood cell layer collection container F5 (claim 15 of Kusters) after collecting said third portion of the separated red blood cells ([0071],ll.14-17; where any part of processes can be repeated or continued [(0148)].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA EISENBERG, can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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