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
The amendment filed 05/11/2026 has been entered. Claims 1-7, 9-11, 13-15 and 18-20 are pending and under consideration.
Response to Arguments
In response to the applicant’s argument with respect to 35 USC 102 and 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation as presented below.
Claim Objections
Claim objected to because of the following informalities
Claim1 line 17 recites “a first parameter” which should read “the first parameter”
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 1-4, 6, 7, 9, 11, 13-15 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Turner (US 20200086034 A1) in view of Crnkovich et al (US 20190038890 A1) and Weiss et al (US 4828543 A).
Regarding claim 1, Turner substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
An extracorporeal blood treatment system (figure 1 and [0001], perfusion system 1), comprising:
a reservoir (figure 1. Reservoir 10);
a first blood pathway (figure 1 [0048] venous line 12 extending between patient and the reservoir) extending between a patient and the reservoir, the first blood pathway including a first pump positioned upstream of the reservoir, a first clamp (figure 1 [0053] flow restricting arrangement 28) and a first sensor (figure 1 [0024 0062], flow sensor 26 configured to monitor a venous flow rate) configured to sense a first parameter ([0024 0062] venous flow rate) of blood flowing through the first blood pathway;
a second blood pathway (figure 1 [0051] outgoing line 22 extending between the reservoir 10 and outlet 24) extending between the reservoir and the patient, the second blood pathway including a second pump (figure 1, pump 20) positioned downstream of the reservoir, a second clamp, and a second sensor (figure 1 [0053], sensor 32 configured to sense outgoing flow value) configured to sense a second parameter of blood flowing through the second blood pathway;
a first control unit ([0055-0069] controller in communication with 26 and 28) in communication with the first pump, the first clamp and the first sensor; and
a second control unit in communication with the second pump, the second clamp, and the second sensor ([0055-0069] controller in communication with pump 20 and sensor 32);
wherein the first sensor is configured to continuously sense the first parameter of blood passing through the first blood pathway ([0024] [0062] sensor 28 continuously monitor a venous flow rate in the venous line 12);
wherein the first sensor is configured to transmit a first signal corresponding to the first parameter to the first control unit ([0061] the flow sensor configured to transmit the venous flow rate to the controller);
wherein the first control unit is configured to receive the first signal and transmit a second signal to the first clamp ([0061] the controller determines the venous flow rate and transmit a control signal to the restricting arrangement 26);
wherein the first clamp is configured to receive the second signal from the first control unit ([0061] 26 receives the control signal from the controller );
wherein, in response to receiving the second signal from the first control unit, the first clamp is configured to automatically:
controllably actuate the first clamp to increase blood flow through the first pathway when the first control unit signals for an increase in blood flow based on the sensed first parameter ([0061] the control signal adjust the 28 to increase the flow rate ); and
controllably actuate the first clamp to decrease blood flow through the first pathway when the first control unit signals for a decrease in blood flow based on the sensed first parameter ([0061] the control signal adjust the 28 to decrease the flow rate );
wherein there is a direct, real-time control relationship between actuating the first clamp and the first parameter responsive to the sensed first parameter ([0058-0062] actively actuating 28 in response to real time reading from the sensor 26) ;
wherein the first control unit is configured to communicate with the second control unit to cooperatively regulate blood flow through the first blood pathway and the second blood pathway.
Turner does not teach the second blood pathway including a second clamp; and
The second control unit in communication with the second clamp.
In the same field of endeavor, namely an infusion method for extracorporeal systems, Crnkovich teaches the system comprising a second clamp ([0080] flow regulators on arterial line set 104) coupled to an arterial blood pathway extending between a patient and a reservoir; and
the control unit in communication with the second clamp ([0080] “in some implementations, these flow regulators are electronically addressable devices that can be operated by the controller 144”).
Crnkovich provides the flow regulators are electronically controlled by the controller in order to control the fluid lines individually ([0080]).
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 Turner to incorporate the teachings of Crnkovich and provide the second clamp and the control unit as claimed for the purpose of controlling fluid flow in the arterial fluid flow to provide more precise flow control. For example, outgoing flow rate can be controlled without adjusting incoming flow rate.
The combination does not teach the system comprising;
a first pump positioned upstream of the reservoir;
a second control unit in communication with the second pump, the second clamp, and the second sensor; and
wherein the first control unit is configured to communicate with the second control unit to cooperatively regulate blood flow through the first blood pathway and the second blood pathway.
In the same field of endeavor, namely an extracorporeal circulation apparatus, Weiss teaches the apparatus (figure 1, 10) comprising a first pump positioned upstream of the reservoir (figure 1, pump 104 positioned upstream of filter 142);
a second control unit (figure 1 and abstract, motor controller 262 in communication with the pump 106 and sensor 236) in communication with the second pump and the second sensor; and
wherein the first control unit is configured to communicate with the second control unit to cooperatively regulate blood flow through the first blood pathway and the second blood pathway (abstract, col 12 lines 1-65, the motor controllers 260 and 262 communicates through the central processor 210 and cooperatively regulate blood flow through tubing 102).
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 Turner, as modified by Crnkovich, to incorporate the teachings of Weiss and provides the control units and the first pump as claimed for the purpose of independently set the rotation speed of the arterial pump and venous pump to achieve precise and predictable flow or pressure conditions with continual feedback from and adjustment of the apparatus as taught by Weiss (col 10 lines 4-23).
Regarding claim 2, Turner, as modified by Crnkovich and Weiss, teaches the blood treatment system of claim 1.
The combination further teaches wherein the first sensor parameter is a first flowrate of blood passing through the first blood pathway. (Turner; [0061] the flow rate in the venous line 12)
Regarding claim 3, Turner, as modified by Crnkovich and Weiss, teaches the blood treatment system of claim 2.
The combination further teaches wherein the first clamp is configured to decrease the first flowrate of blood flowing through the first blood pathway in response to receiving the second signal from the first control unit (Turner; flow restricting arrangement 28 is configured to adjust (e.g., increase) the flow restriction to decrease the flow rate in the venous line).
Regarding claim 4, Turner, as modified by Crnkovich and Weiss, teaches the blood treatment system of claim 2.
The combination further teaches wherein the first clamp is configured to increase the first flowrate of blood flowing through the first blood pathway in response to receiving the second signal from the first control unit (Turner; [0061] and [0061] in response to the control signal, the flow-restricting arrangement is configured to adjust (e.g., decrease) the flow restriction to increase the flow rate).
Regarding claim 6, Turner, as modified by Crnkovich and Weiss, teaches the blood treatment system of claim 1.
The combination further teaches wherein the first sensor is spaced away from the first clamp along the first blood pathway (Turner; figure 1, 26 is spaced away from 28 along 12).
Regarding claim 7, Turner, as modified by Crnkovich and Weiss, teaches the blood treatment system of claim 1.
The combination further teaches wherein the first blood pathway defines a venous pathway from the patient to the reservoir (Turner; [0048] venous line 12 defines a fluid pathway between the patient and reservoir 10).
Regarding claim 9, Turner, as modified by Crnkovich and Weiss, teaches the blood treatment system of claim 1.
The combination further teaches wherein the first control unit is configured to adjust a speed of the first pump based upon the first signal received from the first sensor (Weiss; figure 1 and col 12 and line 41-65, motor controller 260 sets rotational speed and pump rates of the pump 104).
Regarding claim 11, Turner, as modified by Crnkovich and Weiss, teaches the blood treatment system of claim 1.
The combination further teaches wherein the second blood pathway defines an arterial return pathway from the reservoir to the patient (Turner; figure 1, outgoing line 22 between reservoir 10 and patient).
Regarding claim 13, Turner, as modified by Crnkovich and Weiss, teaches the blood treatment system of claim 11.
The combination further teaches wherein the second sensor is configured to sense a second parameter of blood passing through the second blood pathway (Turner; outgoing flow value [0063] “outgoing flow value may be determined by the outgoing flow sensor 32” );
wherein the second sensor is configured to transmit a third signal corresponding to the second parameter to the second control unit (Turner; ([0054]-[0056] outgoing sensor transmit outgoing flow value to the second controller of Weiss, as Weiss suggest the second controller positioned in outgoing tubing)
wherein the second control unit is configured to receive the third signal and transmit a fourth signal to the second pump (Turner; [0054]-[0056] and [0063], upon receiving the outgoing flow value, the controller outputs signal to control and adjust the pump speed);
wherein the second pump is configured to adjust blood flow through the second blood pathway in response to receiving the fourth signal from the second control unit (Turner; [0054]-[0056] and [0063] upon receiving the output signal from the second control unit of Weiss, the pump adjust speed to control outgoing flow rate).
Regarding claim 14, Turner, as modified by Crnkovich and Weiss, teaches the blood treatment system of claim 13.
The combination further teaches wherein the second parameter is a second flowrate of the blood passing through the second blood pathway (Turner; [0054] “The outgoing flow sensor 32 allows the outgoing flow rate, ie the flow rate of the blood provided towards the patient to be measured”).
Regarding claim 15, Turner, as modified by Crnkovich and Weiss, teaches the blood treatment system of claim 14.
The combination further teaches wherein the first blood pathway defines a venous pathway (Turner; [0048] venous line 12 provided to receive venous blood from a patient) from the patient to the reservoir, and wherein the second blood pathway defines an arterial return pathway ([0001]-[0002] the outgoing line 22 defines arterial line, returning blood to patient as arterial blood) from the reservoir back to the patient.
Regarding claim 18, Turner teaches an extracorporeal blood treatment system (figure 1 [0001], perfusion system 1), comprising:
a first clamp (figure 1 and [0053], flow restricting arrangement 28 coupled to venous fluid line 12) coupled to a venous blood pathway extending between a patient and a reservoir;
a second clamp coupled to an arterial blood pathway (figure 1, 22 extending between the reservoir and patient) extending between the patient and the reservoir;
a fluid level sensor ([0031-0032] reservoir level sensor measures a fluid level) coupled to the reservoir, the level sensor configured to sense a level of blood in the reservoir; and
a first control unit ([0031 and 0032] control unit in communication with the restricting arrangement and the level sensor) in communication with the first clamp and the level sensor;
a second control unit in communication with the second clamp;
wherein the level sensor is configured to transmit a first signal to the first control unit, wherein the first signal corresponds to a volume of blood in the reservoir ([0031 and 0032] the level sensor transmits a signal to the control unit corresponding the fluid level in the reservoir);
wherein the first control unit is configured to receive the first signal ([0031 and 0032] the controller is configured to receive the signal from the level sensor) and transmit a second signal to the first clamp ([0060-0061] controller issues a control signal to the flow restricting arrangement 26);
wherein the first clamp is configured to receive the second signal from the first control unit ([0060-0061] 26 is configured to receive the control signal from the controller);
wherein the first clamp is configured to controllably adjust blood flow through the venous pathway in response to receiving the second signal from the first control unit ([0060-0061] 26 is configured to adjust flow rates in response to the control signal);
wherein the second clamp is configured to controllably adjust blood flow through the arterial pathway in response to receiving a third signal from the second control unit;
wherein the first control unit is configured to communicate with the second control unit to cooperatively regulate blood flow through the venous blood pathway and the arterial blood pathway.
Turner does not teach a second clamp coupled to the arterial blood pathway extending between the patient and the reservoir; and
wherein the second clamp is configured to controllably adjust blood flow through the arterial pathway in response to receiving a third signal from the second control unit.
In the same field of endeavor, namely an infusion method for extracorporeal systems, Crnkovich teaches the system comprising a second clamp ([0080] flow regulator on arterial line set 104) coupled to the arterial blood pathway extending between the patient and the reservoir; and
wherein the second clamp is configured to controllably adjust blood flow through the arterial pathway in response to receiving a third signal from the control unit ([0080] “in some implementations, these flow regulators are electronically addressable devices that can be operated by the controller 144b” )
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 Turner to incorporate the teachings of Crnkovich and provides the second clamp as claimed for the purpose of controlling fluid flow in the arterial fluid flow to provide more precise flow control. For example, outgoing flow rate can be controlled without adjusting incoming flow rate as taught by Crnkovich ([0080]).
The combination does not teach the control unit comprises a first and second control units;
wherein the second control unit in communication with the second clamp; and
wherein the first control unit is configured to communicate with the second control unit to cooperatively regulate blood flow through the venous blood pathway and the arterial blood pathway.
In the same field of endeavor, namely an extracorporeal circulation apparatus, Weiss teaches the apparatus (figure 1, 10) comprising first and second motor controllers (figure 1, 260 and 262) and each positioned in venous and anterior sides of the filtering mean (figure 1, 142);
wherein the second control unit in communication with the second clamp (figure 1, motor controller 262 in communication with pump 106, which maps to the second clamp disclosed in Crnkovich above); and
wherein the first control unit is configured to communicate with the second control unit to cooperatively regulate blood flow through the venous blood pathway and the arterial blood pathway (abstract, col 12 lines 1-65, the motor controllers 260 and 262 communicates through the central processor 210 and cooperatively regulate blood flow through tubing 102).
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 Turner, as modified by Crnkovich, to incorporate the teachings of Weiss and provides the control units and the first pump as claimed for the purpose of independently set the rotation speed of the arterial pump and venous pump to achieve precise and predictable flow or pressure conditions with continual feedback from and adjustment of the apparatus as taught by Weiss (col 10 lines 4-23).
Regarding claim 19, Turner, as modified by Crnkovich and Weiss, teaches the blood treatment system of claim 18.
The combination further teaches comprising a first pump (Turner; figure 1, pump 20) positioned upstream of the reservoir in the venous blood pathway, wherein the first pump is in communication with the first control unit (Turner; [0077 and 0079] the pump 22 is in communication with the pump 20), and wherein the first control unit is configured to adjust a speed of the first pump based upon the first signal received from the level sensor (Turner; [0077 and 0079] the pump adjust speed based upon receiving signal corresponding the reservoir level).
The combination does not teach the first pump is positioned upstream of the reservoir in the venous blood pathway.
In the same field of endeavor, namely an extracorporeal circulation apparatus, Weiss teaches pumps positioned on both the upstream and downstream of the filtering mean (figure 1, pumps 104 and 106), and the pumps are controlled by independent motor controllers (figure 1, 260 and 262).
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 Turner, as modified by Crnkovich and Weiss, to incorporate the teachings of Weiss and further include the first pump as claimed for the purpose of independently set the rotation speed of the arterial pump and venous pump to achieve precise and predictable flow or pressure conditions with continual feedback from and adjustment of the apparatus as taught by Weiss (col 10 lines 4-23).
Regarding claim 20, Turner teaches an extracorporeal blood treatment system, comprising:
a first clamp (figure 1 and [0053] flow restricting arrangement 28 coupled to venous fluid line 12 extending between patient and reservoir 10) coupled to a venous blood pathway extending between a patient and a reservoir;
a first sensor (figure 1, flow sensor 26) positioned along the venous blood pathway;
a second clamp coupled to an arterial blood pathway extending between a patient and a reservoir (figure 1, outgoing arterial blood line 22);
a second sensor (figure 1, flow sensor 32 positioned along the outgoing flow line 22) positioned along the arterial blood pathway; and
a system control unit ([0055-0069] controller) including a venous blood pathway control unit and an arterial blood pathway control unit, an wherein the venous blood pathway control unit is in communication with the first clamp and the first sensor ([0055-0069] flow sensor 26 and flow restricting arrangement 28 is in communication with the controller), and wherein the arterial blood pathway control unit is in communication with the second clamp and the second sensor ([0055-0069] the controller also in communication with the flow sensor 32);
wherein the first sensor is configured to continuously transmit a first signal to the first control unit, wherein the first signal corresponds to an instantaneous flowrate of blood in the venous blood pathway ([0024] and [0058-0062] the venous sensor 26 continuously monitors the flow rate and transmit the first signal corresponding the flowrate to the controller);
wherein the second sensor is configured to continuously transmit a second signal to the second control unit, wherein the second signal corresponds to an instantaneous flowrate of blood in the arterial blood pathway ([0054-0056 and 0075] the flow sensor 32 continuously monitors the flowrate of blood in outgoing flow line 22, and transmitting outgoing flow rate to the control unit);
wherein the system control unit is configured to receive the first signal and the second signal ([0054-0056 and 0061] controller configured to receive the venous flow rate and arterial blood flow rate from the sensors);
wherein the system control unit is configured to continuously and simultaneously compare the first signal and the second signal ([0054]-[0056] at least the controller is configured to receive the outgoing flow rate from sensor 32 and set the restriction threshold to set a maximum flow rate through the venous line, and the controller compare and monitors the incoming flow rate with the set restriction threshold); and
wherein the system control unit is configured to automatically actuate the first clamp, the second clamp or both the first clamp and the second clamp in response to comparing the first signal and the second signal to controllably adjust blood flow through the venous pathway, the arterial blood pathway or both the venous pathway and the arterial blood pathway ([0054-0056] the restricting arrangement 28 comprising a motorized clamp automatically actuate to adjust the flow rate through the venous line 12 in response to comparing the flow rate with the set restriction threshold).
Turner does not teach a second clamp coupled to the arterial blood pathway
In the same field of endeavor, namely an infusion method for extracorporeal systems, Crnkovich teaches the system comprising a second clamp ([0080] flow regulator on arterial line set 104) coupled to the arterial blood pathway extending between the patient and the reservoir; and
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 Turner to incorporate the teachings of Crnkovich and provides the second clamp as claimed for the purpose of controlling fluid flow in the arterial fluid flow to provide more precise flow control. For example, outgoing flow rate can be controlled without adjusting incoming flow rate as taught by Crnkovich ([0080]).
The combination does not teach the system control unit including a venous blood pathway control unit and an arterial blood pathway control unit
wherein the venous blood pathway control unit is in communication with the first clamp and the first sensor, and wherein the arterial blood pathway control unit is in communication with the second clamp and the second sensor.
In the same field of endeavor, namely an extracorporeal circulation apparatus, Weiss teaches the apparatus (figure 1, 10) comprising the system control unit (figure 1, central processor 210), the system control unit including a venous blood pathway control unit (figure 1, 260) and an arterial blood pathway control unit (figure 1, 262) and each positioned in venous and arterial sides across the filtering mean (figure 1, 142); and
wherein the venous blood pathway control unit is in communication with the first clamp and the first sensor (figure 1 abstract col 12 lines 1-65, the motor controller 260 is in communication with pump 104 and sensor 220 through the central processor 210, the pump 104 maps to the first clamp of the Turner), and wherein the arterial blood pathway control unit (figure 1 abstract col 12 lines 1-65, the motor controller 262 is in communication with pump 106 and sensor 236 through the central processor 210, the pump 106 maps to the second clamp of Crnkovich) is in communication with the second clamp and the second sensor.
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 Turner, as modified by Crnkovich, to incorporate the teachings of Weiss and provides the control units as claimed for the purpose of independently set the rotation speed of the arterial pump and venous pump to achieve precise and predictable flow or pressure conditions with continual feedback from and adjustment of the apparatus as taught by Weiss (col 10 lines 4-23).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Turner (US 20200086034 A1) in view of Crnkovich et al (US 20190038890 A1) and Weiss et al (US 4828543 A), and in further view of Janik (US 20220133975 A1)
Regarding claim 5, Turner, as modified by Crnkovich and Weiss, teaches the blood treatment system of claim 1.
The combination does not teach wherein the first sensor is directly attached to the first clamp.
In the same field of endeavor, namely an extracorporeal blood line set, Janik teaches wherein the first sensor is directly attached to the first clamp ([0019 and 0036] ultrasonic sensor 16 integrally arranged on the valve 11).
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 Turner, as modified by Crnkovich and Weiss, to incorporate the teachings of Janik and provides the first sensor and the clamp as claimed, and one of skill in the art motivated to do so, for the purpose of simplifying device manufacture by providing integrated clamp and sensor assembly
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Turner (US 20200086034 A1) in view of Crnkovich et al (US 20190038890 A1) and Weiss et al (US 4828543 A)., and in further view of Ekdahl et al (US 20120318740 A1).
Regarding Claim 10, Turner, as modified by Crnkovich and Weiss, teaches the blood treatment of claim 9.
The combination does not teach wherein the first clamp is configured to automatically close to a shutdown condition in response to a shutdown signal from the first control unit.
However, in the same field of endeavor, namely an apparatus for extracorporeal blood treatment, Ekdahl teaches wherein the first clamp is configured to automatically close to a shutdown condition in response to a shutdown signal from the control unit ([0033] “kink in the blood transport line, and/or that the first needle (through which blood is withdrawn) has been dislodged. Under those conditions, the treatment control monitor 100 will normally stop the treatment (stop the blood pump 110 and close the withdrawal line clamp and the return line clamp)”).
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 Turner, as modified by Crnkovich and Weiss and, to incorporate the teachings of Ekdahl and provides the first clamp as claimed for the purpose of preventing blood loose from blood leakage, needle dislodgement, or kinks in the blood transport line, as taught by Ekdahl ([0033]).
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 SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SETH HAN/Examiner, Art Unit 3781
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