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 .
Response to Amendment
Applicant’s amendments filed on 02/03/2026 have been fully considered. Claims 1-20 are pending in this application. Claims 1, 6-7, 11, 14, and 16-17 are amended.
Response to Arguments
Applicant’s arguments with respect to amended independent claim(s) 1 and 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Though some of the same prior art reference is re-used herein, amended claim 1 and 11 required a change in the grounds of rejection relying on additional prior art as detailed below in the prior art rejection. In particular, the claim limitations “(f) input the error signal into a proportional-integral-derivative control algorithm having a plurality of proportional-integral-derivative gains and an execution time to generate a control signal, and(g) repeat (a) - (f) with said outflow rate being modified by the controller based at least in part on the control signal and with at least one of the proportional- integral derivative gains or the execution time of said proportional-integral-derivative control algorithm being modified by the controller when a value of at least one of said plurality of blood characteristics, at least one of said plurality of source characteristics, and/or the inflow rate when executing (a) is different from the corresponding value when most recently executing (a)” and further narrows the scope of the claimed invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3-7, 10-11, 13-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Min et al. (Publication No. US 2019/0201916 A1) in view of Kienman et al. (Publication No. US 2009/0012655 A1).
Regarding claim 1, Min teaches a blood separation device (device 10; Figure 1; Paragraph 0079-0080), comprising:
a pump system (pumps P1-P6; Paragraph 0099; Figure 1);
a centrifugal separator (centrifugal separator 16; Figure 12; Paragraph 0079);
an interface monitoring assembly (interface monitoring system; Figures 12A-12C; Paragraph 0092-0094); and
a controller (controller 18; Figure 1; Paragraph 0079 and 0081), wherein the controller is configured to
(a) actuate the pump system to pump blood having a plurality of blood characteristics from a blood source having a plurality of source characteristics into the centrifugal separator at an inflow rate (controller 18 to actuate pumps P1-P6 to pump blood, obvious that blood has a plurality of blood characteristics, from a blood source, obvious that blood source has source characteristics, into the centrifugal separator 16 at a flow rate; Paragraph 0108),
(b) actuate the centrifugal separator to separate the blood in the centrifugal separator into two blood components, with an interface therebetween (controller 18 actuates separator 16 to separate blood with an interface between the separated blood components; Paragraph 0092-0094 and 0111),
(c) actuate the pump system to pump one of said blood components out of the centrifugal separator at an outflow rate (controller 18 actuates pumps P1-P6 to pump blood out of separator 16 at a flow rate; Paragraph 0099, 0108, and 0111),
(d) actuate the interface monitoring assembly to determine a current position of the interface within the centrifugal separator (controller 18 actuated the interface monitoring system to determine the current state of the interface in the separator 16; Paragraph 0092-0094),
(e) compare the current position of the interface to a target interface position and generate an error signal indicative of a distance between the current position of the interface and the target interface position (controller determines if the interface is in the correct position by comparison and will issue commands to move position to target position; Paragraph 0094 and 0169-0172),
(f) input the error signal into a proportional-integral-derivative control algorithm to generate a control signal (Paragraph 0172), and
(g) repeat (a) - (f) with said outflow rate being modified by the controller based at least in part on the control signal when a value of at least one of said plurality of blood characteristics, at least one of said plurality of source characteristics, and/or the inflow rate when executing (a) is different from the corresponding value when most recently executing (a) (outflow rate changes based on targeted red blood cell percentage or plasma percentage, which are blood characteristics, or inflow rate, mentioned in Paragraph 0111 and 0143; Paragraph 0169-0172).
Min does not teach (f) input the error signal into a proportional-integral-derivative control algorithm having a plurality of proportional-integral-derivative gains and an execution time to generate a control signal, and (g) repeat (a) - (f) with said outflow rate being modified by the controller based at least in part on the control signal and with at least one of the proportional-integral derivative gains or the execution time of said proportional-integral-derivative control algorithm being modified by the controller.
However, Kienman teaches (f) input the error signal into a proportional-integral-derivative control algorithm having a plurality of proportional-integral-derivative gains and an execution time to generate a control signal (error signal is placed into PID algorithm having PID gains and time used of feedforward determination; Paragraph 0035), and (g) repeat (a) - (f) with said outflow rate being modified by the controller based at least in part on the control signal and with at least one of the proportional-integral derivative gains or the execution time of said proportional-integral-derivative control algorithm being modified by the controller (PID gains or execution time of the feedforward determination is adjusted in the feedback loop to reduce error; Paragraph 0035).
Min and Kienman are considered to be analogous to the claimed invention because they are in the same field of fluid pump based systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Min to incorporate the teachings of Kienman and have the controller of Min be configured to have a feedback loop to adjust the PID gains and the time used in feedforward determination, as taught by Kienman, based on the setpoint data received from the system of Min. This allows for the controller to fine tune the performance of the device operation based on the control signal received (Kienman; Paragraph 0034-0035).
Regarding claim 3, Min in view of Kienman teaches the blood separation device of claim 1. Min further teaches wherein one of said plurality of blood characteristics is a hematocrit of the blood (controller 18 monitors hematocrit/RBC percentage for adjusting rate; Paragraph 0169-0171 and 0195).
Regarding claim 4, Min in view of Kienman teaches the blood separation device of claim 1. Min further teaches wherein the controller is programmed with or configured to access a database comprising a plurality of selectable proportional-integral-derivative gains to be incorporated into said proportional-integral-derivative control algorithm, and each of said proportional-integral-derivative gains is based at least in part on at least one of said plurality of blood characteristics, at least one of said plurality of source characteristics, and/or the inflow rate (controller 18 has an operator interface station, comprising a database, to allow for operator to select applications/procedures to be executed, which are proportional-integral-derivative gains that are selectable to complete different procedures to achieve desired blood characteristic values – PID algorithms require PID gain values to operate; Paragraph 0105-0106, 0113, and 0175-0176).
Regarding claim 5, Min in view of Kienman teaches the blood separation device of claim 4. Min further teaches wherein the controller is configured to, prior to beginning a blood separation procedure, select from the database the proportional-integral-derivative gains to be initially employed when beginning the blood separation procedure (controller 18 has an operator interface station comprising a database to allow for operator to select applications/procedures to be executed, which are proportional-integral-derivative gains that are selectable to complete different procedures to achieve desired blood characteristic values – PID algorithms require PID gain values to operate; Paragraph 0105-0106, 0113, and 0175-0176).
Regarding claim 6, Min in view of Kienman teaches the blood separation device of claim 1. The combination of Min in view of Kienman further teaches wherein the controller is configured to modify the execution time of said proportional-integral-derivative control algorithm when said value of at least one of said plurality of blood characteristics, at least one of said plurality of source characteristics, and/or the inflow rate when executing (a) is different from the corresponding value when most recently executing (a) (feedback loop of Kienman can modify the PID gains and execution time of the feedback loop based on the control signal versus the setpoint value, the control signal is the value of the blood characteristics, monitored by the controller and the system of Min; see rejection of claim 1 above).
Regarding claim 7, Min in view of Kienman teaches the blood separation device of claim 1. The combination of Min in view of Kienman further teaches wherein the controller is configured to modify at least one of the proportional-integral-derivative gains and the execution time of said proportional-integral-derivative control algorithm when said value of at least one of said plurality of blood characteristics, at least one of said plurality of source characteristics, and/or the inflow rate when executing (a) is different from the corresponding value when most recently executing (a) (feedback loop of Kienman can modify the PID gains and execution time of the feedback loop based on the control signal versus the setpoint value, the control signal is the value of the blood characteristics, monitored by the controller and the system of Min; see rejection of claim 1 above).
Regarding claim 10, Min in view of Kienman teaches the blood separation device of claim 1. Min further teaches wherein the blood source is a non-living blood source (Paragraph 0102).
Regarding claim 11, Min teaches a method for separating blood (Abstract; Paragraph 0072), comprising:
(a) conveying blood having a plurality of blood characteristics from a blood source having a plurality of source characteristics into a centrifugal separator at an inflow rate (controller 18 to actuate pumps P1-P6 to pump blood, obvious that blood has a plurality of blood characteristics, from a blood source, obvious that blood source has source characteristics, into the centrifugal separator 16 at a flow rate; Paragraph 0108);
(b) separating the blood in the centrifugal separator into two blood components, with an interface therebetween (controller 18 actuates separator 16 to separate blood with an interface between the separated blood components; Paragraph 0092-0094 and 0111);
(c) conveying one of said blood components out of the centrifugal separator at an outflow rate (controller 18 actuates pumps P1-P6 to pump blood out of separator 16 at a flow rate; Paragraph 0099, 0108, and 0111);
(d) determining a current position of the interface within the centrifugal separator (controller 18 actuated the interface monitoring system to determine the current state of the interface in the separator 16; Paragraph 0092-0094);
(e) comparing the current position of the interface to a target interface position and generating an error signal indicative of a distance between the current position of the interface and the target interface position (controller determines if the interface is in the correct position by comparison and will issue commands to move position to target position; Paragraph 0094 and 0169-0172);
(f) inputting the error signal into a proportional-integral-derivative control algorithm to generate a control signal (Paragraph 0172); and
(g) repeating (a) - (f) with said outflow rate being modified based at least in part on the control signal when a value of at least one of said plurality of blood characteristics, at least one of said plurality of source characteristics, and/or the inflow rate when executing (a) is different from the corresponding value when most recently executing (a) (outflow rate changes based on targeted red blood cell percentage or plasma percentage, which are blood characteristics, or inflow rate, mentioned in Paragraph 0111 and 0143; Paragraph 0169-0172).
Min does not teach (f) inputting the error signal into a proportional-integral-derivative control algorithm having a plurality of proportional-integral-derivative gains and an execution time to generate a control signal and (g) repeating (a) - (f) with said outflow rate being modified based at least in part on the control signal and with at least one of the proportional-integral-derivative gains or the execution time of said proportional-integral-derivative control algorithm being modified.
However, Kienman teaches (f) inputting the error signal into a proportional-integral-derivative control algorithm having a plurality of proportional-integral-derivative gains and an execution time to generate a control signal (error signal is placed into PID algorithm having PID gains and time used of feedforward determination; Paragraph 0035) and (g) repeating (a) - (f) with said outflow rate being modified based at least in part on the control signal and with at least one of the proportional-integral-derivative gains or the execution time of said proportional-integral-derivative control algorithm being modified (PID gains or execution time of the feedforward determination is adjusted in the feedback loop to reduce error; Paragraph 0035).
Min and Kienman are considered to be analogous to the claimed invention because they are in the same field of fluid pump based systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Min to incorporate the teachings of Kienman and have the controller of Min be configured to have a feedback loop to adjust the PID gains and the time used in feedforward determination, as taught by Kienman, based on the setpoint data received from the system of Min. This allows for the controller to fine tune the performance of the device operation based on the control signal received (Kienman; Paragraph 0034-0035).
Regarding claim 13, Min in view of Kienman teaches the method of claim 11. Min further teaches wherein one of said plurality of blood characteristics is a hematocrit of the blood (controller 18 monitors hematocrit/RBC percentage for adjusting rate; Paragraph 0169-0171 and 0195).
Regarding claim 14, Min in view of Kienman teaches the method of claim 11. Min further teaches wherein modifying the proportional-integral-derivative control algorithm includes selecting from a database at least one of a plurality of selectable proportional-integral-derivative gains to be incorporated into said proportional-integral-derivative control algorithm, and each of said proportional-integral-derivative gains is based at least in part on at least one of said plurality of blood characteristics, at least one of said plurality of source characteristics, and/or the inflow rate (controller 18 has an operator interface station, comprising a database, to allow for operator to select applications/procedures to be executed, which are proportional-integral-derivative gains that are selectable to complete different procedures to achieve desired blood characteristic values – PID algorithms require PID gain values to operate; Paragraph 0105-0106, 0113, and 0175-0176).
Regarding claim 15, Min in view of Kienman teaches the method of claim 14. Min further teaches further comprising, prior to beginning blood separation, selecting from the database the proportional-integral-derivative gains to be initially employed when beginning blood separation (controller 18 has an operator interface station comprising a database to allow for operator to select applications/procedures to be executed, which are proportional-integral-derivative gains that are selectable to complete different procedures to achieve desired blood characteristic values – PID algorithms require PID gain values to operate; Paragraph 0105-0106, 0113, and 0175-0176).
Regarding claim 16, Min in view of Kienman teaches the method of claim 11. The combination of Min in view of Kienman further teaches wherein the execution time of said proportional-integral-derivative control algorithm is modified when said value of at least one of said plurality of blood characteristics, at least one of said plurality of source characteristics, and/or the inflow rate when executing (a) is different from the corresponding value when most recently executing (a) (feedback loop of Kienman can modify the PID gains and execution time of the feedback loop based on the control signal versus the setpoint value, the control signal is the value of the blood characteristics, monitored by the controller and the system of Min; see rejection of claim 11 above).
Regarding claim 17, Min in view of Kienman teaches the method of claim 11. The combination of Min in view of Kienman further teaches wherein at least one of the proportional-integral-derivative gains and the execution time of said proportional-integral-derivative control algorithm are modified when said value of at least one of said plurality of blood characteristics, at least one of said plurality of source characteristics, and/or the inflow rate when executing (a) is different from the corresponding value when most recently executing (a) (feedback loop of Kienman can modify the PID gains and execution time of the feedback loop based on the control signal versus the setpoint value, the control signal is the value of the blood characteristics, monitored by the controller and the system of Min; see rejection of claim 1 above).
Regarding claim 20, Min in view of Kienman teaches the method of claim 11. Min further teaches wherein the blood source is a non-living blood source (Paragraph 0102).
Claim(s) 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Min et al. (Publication No. US 2019/0201916 A1) in view of Kienman et al. (Publication No. US 2009/0012655 A1), as applied to claims 1 and 11 above, and further in view of Lucke et al. (Publication No. US 2002/0150476 A1).
Regarding claim 2, Min in view of Kienman teaches the blood separation device of claim 1. The combination of Min in view of Kienman does not teach wherein one of said plurality of blood characteristics is a temperature of the blood.
However, Lucke teaches wherein one of said plurality of blood characteristics is a temperature of the blood (temperature sensor 50e is connected to a controller of Figure 1 – sensors, including temperature sensor, can help monitor and control pumps, similar to the structure of Figure 18; Paragraphs 0029, 0126-0127, and 130).
Min in view of Kienman and Lucke are considered to be analogous to the claimed invention because they are in the same field of blood flow systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Min in view of Kienman to incorporate the teachings of Lucke and have the temperature sensor of Lucke and the method of controlling the pump by comparing the threshold temperature values to the current value, as taught by Lucke, connected to the proportional-integral-derivative controller of Min in view of Kienman. This allows for the device to be controlled by different characteristics of the blood, such as temperature (Lucke; Paragraph 0127), and in the case the value of the characteristic exceeds a given threshold (Lucke; Paragraph 0129-0131).
Regarding claim 12, Min in view of Kienman teaches the method of claim 11. Min in view of Kienman does not teach wherein one of said plurality of blood characteristics is a temperature of the blood.
However, Lucke teaches wherein one of said plurality of blood characteristics is a temperature of the blood (temperature sensor 50e is connected to a controller of Figure 1 – sensors, including temperature sensor, can help monitor and control pumps, similar to the structure of Figure 18; Paragraphs 0029, 0126-0127, and 130).
Min in view of Kienman and Lucke are considered to be analogous to the claimed invention because they are in the same field of blood flow systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Min in view of Kienman to incorporate the teachings of Lucke and have the temperature sensor of Lucke and the method of controlling the pump by comparing the threshold temperature values to the current value, as taught by Lucke, connected to the proportional-integral-derivative controller of Min in view of Kienman. This allows for the device to be controlled by different characteristics of the blood, such as temperature (Lucke; Paragraph 0127), and in the case the value of the characteristic exceeds a given threshold (Lucke; Paragraph 0129-0131).
Claim(s) 8-9 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Min et al. (Publication No. US 2019/0201916 A1) in view of Kienman et al. (Publication No. US 2009/0012655 A1), as applied to claims 1 and 11 above, and further in view of Ragusa (Publication No. US 2021/0205526 A1).
Regarding claim 8, Min in view of Kienman teaches the blood separation device of claim 1. Min further teaches wherein the blood source is a living blood source (Paragraph 0098). Min does not teach one of said plurality of source characteristics is the age of the blood source.
However, Ragusa teaches one of said plurality of source characteristics is the age of the blood source (Claim 10-12).
Min in view of Kienman and Ragusa are considered to be analogous to the claimed invention because they are in the same field of blood separation systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Min to incorporate the teachings of Ragusa and have the controller of Min in view of Kienman be configured to base the operation of the proportional-integral-derivative controller with the information of age. This allows for the device to provide a personalized blood separation procedure based on the physiology of the donor (Ragusa; Claims 10-12).
Regarding claim 9, Min in view of Kienman teaches the blood separation device of claim 1. Min further teaches wherein the blood source is a living blood source (Paragraph 0098). Min does not teach one of said plurality of source characteristics is the sex of the blood source.
However, Ragusa teaches one of said plurality of source characteristics is the sex of the blood source (Claim 10-12).
Min in view of Kienman and Ragusa are considered to be analogous to the claimed invention because they are in the same field of blood separation systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Min to incorporate the teachings of Ragusa and have the controller of Min in view of Kienman be configured to base the operation of the proportional-integral-derivative controller with the information of sex. This allows for the device to provide a personalized blood separation procedure based on the physiology of the donor (Ragusa; Claims 10-12).
Regarding claim 18, Min in view of Kienman teaches the method of claim 11. . Min further teaches wherein the blood source is a living blood source (Paragraph 0098). Min does not teach one of said plurality of source characteristics is the age of the blood source.
However, Ragusa teaches one of said plurality of source characteristics is the age of the blood source (Claim 10-12).
Min in view of Kienman and Ragusa are considered to be analogous to the claimed invention because they are in the same field of blood separation systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Min in view of Kienman to incorporate the teachings of Ragusa and have the controller of Min in view of Kienman be configured to base the operation of the proportional-integral-derivative controller with the information of age. This allows for the device to provide a personalized blood separation procedure based on the physiology of the donor (Ragusa; Claims 10-12).
Regarding claim 19, Min in view of Kienman teaches the method of claim 11. Min further teaches wherein the blood source is a living blood source (Paragraph 0098). Min does not teach one of said plurality of source characteristics is the sex of the blood source.
However, Ragusa teaches one of said plurality of source characteristics is the sex of the blood source (Claim 10-12).
Min in view of Kienman and Ragusa are considered to be analogous to the claimed invention because they are in the same field of blood separation systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Min in view of Kienman to incorporate the teachings of Ragusa and have the controller of Min in view of Kienman be configured to base the operation of the proportional-integral-derivative controller with the information of sex. This allows for the device to provide a personalized blood separation procedure based on the physiology of the donor (Ragusa; Claims 10-12).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781
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