DETAILED ACTION
Paragraph number references to the instant application’s specifications refer to the US Pg-Pub version (2025/0226086)
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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/639255, filed on Aug-18 2018.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 26-45 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 26, and all claims which depend on it, are unclear as to whether it is the blood pump, the pump unit, or the drive unit that is configured to convey blood from a blood flow inlet towards a blood flow outlet. For the purpose of examination this limitation is interpreted as “an intravascular blood pump for percutaneous insertion into a patient's blood vessel configured to convey blood from a blood flow inlet towards a blood flow outlet, the blood pump comprising a pump unit and a drive unit for driving the pump unit, wherein:”
Additionally, claim 45 recites “wherein the blood pump is a low inertia device.” The term “low inertia” in claim 45 is a relative term which renders the claim indefinite. The term “low inertia” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear how low the inertia must be for a device to qualify as a low inertia device.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 26-45 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 & 6-17 of U.S. Patent No. 12211615. Although the claims at issue are not identical, they are not patentably distinct from each other as laid out in the table below.
Instant Application18/979530
Conflicting
Patent
US 10814131
Differences
Claim 26
A control device for controlling a blood flow Qpump(t) of an intravascular blood pump for percutaneous insertion into a patient's blood vessel, the blood pump comprising a pump unit and a drive unit for driving the pump unit that is configured to convey blood from a blood flow inlet towards a blood flow outlet, wherein: the control device is configured to operate the blood pump in a selectable flow control mode,
Claim 1
A control device for controlling a blood flow Q pump(t) of an intravascular blood pump for percutaneous insertion into a patient's blood vessel, the blood pump comprising a pump unit and a drive unit for driving the pump unit that is configured to convey blood from a blood flow inlet towards a blood flow outlet, wherein the control device is configured to operate the blood pump in a selectable zero-flow control mode
wherein a blood flow command signal Qpumpset(t) between 0 and 1 L/min is selected,
Claim 1
configured to operate the blood pump in a selectable zero-flow control mode
…
wherein a blood flow command signal is selected
and the control device comprises a first controller and a second controller, wherein the first controller is configured to control the blood flow Qpump(t) by adjusting a speed command signal npumpset(t) for the drive unit, and the second controller is configured to control a drive speed npump(t) of the drive unit in accordance with the speed command signal npumpset(t).
the control device comprises a first controller and a second controller, wherein the first controller is configured to control the blood flow by adjusting a speed command signal for the drive unit, and the second controller is configured to control a drive speed of the drive unit.
Claim 27
The control device of claim 26, wherein the selectable flow control mode is a selectable zero-flow control mode and wherein the blood flow command signal Qpumpset(t) is between i) 0 and 0.5 L/min, ii) 0 and 0.2 L/min, or iii) 0 and 0.1 L/min.
Claim 1
configured to operate the blood pump in a selectable zero-flow control mode
…
wherein a blood flow command signal is selected
Claim 28
The control device of claim 26, wherein the first controller is further configured to determine the speed command signal Qpumpset(t) based on a difference ΔQ between the blood flow command signal Qpumpset(t) and the blood flow Qpump(t).
Claim 2
The control device of claim 1, wherein the first controller is further configured to determine the speed command signal based on a difference between the blood flow command signal and the blood flow
Claim 29
The control device of claim 26, wherein the second controller is configured to control the drive speed npump(t) by adjusting a drive current Ipump(t) supplied to the drive unit.
Claim 3
The control device of claim 1, wherein the second controller (402) is configured to control the drive speed by adjusting a drive current supplied to the drive unit.
Claim 30
The control device of claim 26, wherein the first controller and the second controller are part of a cascade control system, in which the first controller is an outer controller and the second controller is an inner controller.
Claim 4
wherein the first controller and the second controller are part of a cascade control system, in which the first controller is an outer controller and the second controller is an inner controller.
Claim 31
The control device of claim 26, wherein the control device is configured to control the blood flow Qpump(t) for a predetermined zero-flow control period.
Claim 1
wherein the control device is configured to operate the blood pump in a selectable zero-flow control mode for a predetermined period.
Claim 32
The control device of claim 31, wherein the predetermined zero-flow control period is set to last a fraction of one cardiac cycle of an assisted heart.
Claim 6
The control device of claim 5 (depends back to claim 1), wherein the predetermined zero-flow control period is set to last a fraction of one cardiac cycle of an assisted heart
Claim 33
The control device of claim 31, wherein the predetermined zero-flow control period is set to last at least one complete cardiac cycle or a predetermined number of complete consecutive cardiac cycles.
or the predetermined zero-flow control period is set to last at least one complete cardiac cycle or a predetermined number of complete consecutive heart cycles.
Claim 34
The control device of claim 31, wherein the control device is configured to synchronize the predetermined zero-flow control period with an occurrence of at least one characteristic heart cycle event.
Claim 7
The control device of claim 5, wherein the control device is configured to synchronize the zero-flow control period with an occurrence of at least one characteristic heart cycle event.
Claim 35
The control device of claim 34, wherein at least one of a start and an end of the predetermined zero-flow control period is synchronized with the occurrence of the at least one characteristic heart cycle event.
Claim 8
The control device of claim 7, wherein at least one of a beginning or an end of the zero-flow control period is synchronized with the occurrence of the at least one characteristic heart cycle event.
Claim 36
The control device of claim 35, wherein the at least one characteristic heart cycle event is opening of an aortic valve or closing of the aortic valve.
Claim 9
The control device of claim 8, wherein the at least one characteristic heart cycle event is an opening of an aortic valve or a closing of an aortic valve.
Claim 37
The control device of claim 26, wherein the control device is configured to operate the blood pump in a zero-flow control mode periodically or randomly.
Claim 11
The control device of claim 1, wherein the control device is configured to operate the blood pump in the zero-flow control mode periodically or randomly.
Claim 38
The control device of claim 26, wherein the control device is configured to monitor values of one or more characteristic heart parameters.
Claim 10
The control device of claim 1, wherein the control device is configured to monitor values of one or more characteristic heart parameters.
Claim 39
The control device of claim 38, wherein the control device is configured to identify a trend of the monitored values of the one or more characteristic heart parameters.
Claim 12
The control device of claim 1, wherein the control device is configured to identify a trend of the characteristic heart parameters.
Claim 40
The control device of claim 38, wherein the one or more characteristic heart parameters are at least one of: arterial pressure pulsatility AOP|max−AOP|min, mean arterial pressure, heart contractility dLVP(t)/dt|max, heart relaxation dLVP(t)/dt|min, and heart rate HR.
Claim 13
The control device of claim 12, wherein the characteristic heart parameter is at least one of: arterial pressure pulsatility, mean arterial pressure, contractility of the heart, relaxation of the heart, or heart rate.
Claim 41The control device of claim 26, wherein the control device is configured to measure the blood flow Qpump(t) using a sensor.
Claim 14
The control device of claim 1, wherein the control device is configured to measure the blood flow by means of a sensor
Claim 42The control device of claim 26, wherein the control device is configured to calculate the blood flow Qpump(t).
or to calculate or estimate the blood flow.
Claim 43
The control device of claim 26, wherein the control device is configured to determine the blood flow Qpump(t) using a look-up table which represents a relationship between the blood flow Qpump(t), the drive speed npump(t), and at least one of a pressure difference ΔPpump(t) between the blood flow outlet and the blood flow inlet and a drive current Ipump(t) supplied to the drive unit.
Claim 15
The control device of claim 1, wherein the control device is configured to determine the blood flow using a look-up table which represents a relationship between the blood, the drive speed, and at least one of a pressure difference between the blood flow outlet and the blood flow inlet and a drive current supplied to the drive unit.
Claim 44
A system comprising an intravascular blood pump for percutaneous insertion into a patient's blood vessel and the control device of claim 26.
Claim 16
A system comprising an intravascular blood pump for percutaneous insertion into a patient's blood vessel and a control device for controlling a blood flow of the intravascular blood pump, the blood pump comprising a pump unit and a drive unit for driving the pump unit that is configured to convey blood from a blood flow inlet toward a blood flow outlet, wherein the control device is configured to operate the blood pump in a selectable zero-flow control mode in order to assess patient recovery status by detecting a characteristic parameter of a heart of the patient during the selectable zero-flow control mode, wherein a blood flow command signal is selected, and the control device comprises a first controller and a second controller, wherein the first controller is configured to control the blood flow by adjusting a speed command signal for the drive unit, and the second controller is configured to control a drive speed of the drive unit.
Claim 45
The system of claim 44, wherein the blood pump is a low inertia device.
Claim 17
The system of claim 16, wherein the blood pump comprises one or more moving parts and is a low inertia device.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 26-27, 29, 31-36, 38-39, 41, & 44-45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishimura et al. (2011/0112354 hereinafter, Nishimura), in view of Spanier et al. (2015/0141842 hereinafter, Spanier).
With regard to claim 26-27, 29, 31-36, 38-39, 41, & 44-45. Nishimura teaches a control device for controlling a blood flow Qpump(t) of a blood pump(“an artificial heart control device for controlling a blood pump which assists flow of blood in a heart, the artificial heart” in [0015]) for percutaneous insertion into a patient's blood vessel, the blood pump comprising a pump unit (Fig.s 1-4 “an embodiment of the present invention includes a blood pump (a pump, a motor, an artificial heart pump) 10” in [0065]) and a drive unit (13 in Fig. 3 and an impeller 13 which is driven by way of a rotary shaft of the motor” in [0071]) for driving the pump unit that is configured to convey blood from a blood flow inlet towards a blood flow outlet (“The blood pump 10 is configured such that when blood in a left ventricle of a patient's own heart flows into the pump casing 14 via a blood vessel (artificial blood vessel) and an inflow port 15, after flow energy is imparted by the impeller 13, the blood flows out to a main artery via an outflow port 16 formed in a side surface of the pump casing 14 and a blood vessel (artificial blood vessel)” in [0071]) wherein: the control device is configured to operate the blood pump in a selectable flow control mode (“in an artificial heart system used in general, to check the degree of recovery of a patient's own heart, it is necessary to perform an OFF pump test in which a blood pump is stopped in a proper manner” in [0160]) wherein a blood flow command signal Qpumpset(t) between 0 and 1 L/min is selected (“such that an output flow rate of the blood pump 10 becomes 0 in systole of a heart and a reverse flow rate of the blood pump 10 becomes 0 in diastole of the heart” in [0161]), and the control device comprises a first controller and a second controller, wherein the first controller is configured to control the blood flow Qpump(t) by adjusting a speed command signal npumpset(t) for the drive unit (68 in Fig. 5 and “the control pattern decision part 68 may, based on the detection result, just decide a control pattern in which the rotational speed of the blood pump” in [0162]) and the second controller is configured to control a drive speed npump(t) of the drive unit in accordance with the speed command signal npumpset(t) (62 in Fig. 5 and “then, the blood pump control part 62 controls the rotational speed of the blood pump 10 based on the control pattern” in [0162]), wherein the selectable flow control mode is a selectable zero-flow control mode and wherein the blood flow command signal Qpumpset(t) is between i) 0 and 0.5 L/min, ii) 0 and 0.2 L/min, or iii) 0 and 0.1 L/min (“such that an output flow rate of the blood pump 10 becomes 0 in systole of a heart” in [0161]), wherein the second controller is configured to control the drive speed npump(t) by adjusting a drive current Ipump(t) supplied to the drive unit (Drive Current in Fig. 5 and “a rotational speed of the blood pump 10 is controlled using the drive current” in [0103]), wherein the control device is configured to control the blood flow Qpump(t) for a predetermined zero-flow control period (“The control pattern calculation part 90 calculates… a control pattern for controlling a rotational speed of the blood pump 10 within one or a plurality of cardiac cycles… the control pattern calculation part 90 calculates… a period” in [0106]), wherein the control device is configured to monitor values of one or more characteristic heart parameters (“The sensor 30 preferably detects at least one of, for example, an electrocardiogram, a blood flow rate and a blood pressure of the patient's own heart 200, an operation state of the blood pump 10, and other measured values having high correlation with a cardiac cycle” in [0078]), wherein the predetermined zero-flow control period is set to last a fraction of one cardiac cycle of an assisted heart (“by controlling the rotational speed of the blood pump 10 with reference to the reference timing such that the rotational speed of the blood pump 10 is lowered in diastole of the heart and the rotational speed of the blood pump 10 is increased in systole of the heart, it is possible to allow the artificial heart control device to assist the cardiac muscle in systole and to prevent the artificial heart control device from impeding the movement of the cardiac muscle in diastole” in [0141], see Fig. 13A), wherein
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the predetermined zero-flow control period is set to last at least one complete cardiac cycle or a predetermined number of complete consecutive cardiac cycles ((“The control pattern calculation part 90 calculates… a control pattern for controlling a rotational speed of the blood pump 10 within one or a plurality of cardiac cycles” in [0106], see figure 13E, which illustrates a control patter lasting for several cardiac cycles), wherein
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the control device is configured to synchronize the predetermined zero-flow control period with an occurrence of at least one characteristic heart cycle event (“the reference timing may be start timing of systole within the cardiac cycle” in [0018] and “in the artificial heart control device according to the present invention, the blood pump control part can control, with reference to the reference timing, the rotational speed of the blood pump such that a blood flow in the ventricle of the heart changes” in [0022]),frequency at which a rotational speed of the blood pump 10 is changed by Y times (Y being a natural number equal to X or less than X) for X pulses (X being a natural number equal to 1 or more than 1), wherein the at least one characteristic heart cycle event is opening of an aortic valve or closing of the aortic valve. (“the reference timing may be start timing of systole within the cardiac cycle” in [0018]. The examiner notes that in [0033] of the specifications of instant application, applicant explains that “the control device can be configured to detect the opening of the aortic valve by… he occurrence of the R-wave in an electrocardiogram”. As illustrated in Fig. 12, Nishimura uses the occurrence of the R-wave to make the beginning of systole. Therefore, “start timing of systole” reads on opening of an aortic valve).
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Nishimura does not teach an intravascular blood pump, the control device of claim 38, wherein the control device is configured to identify a trend of the monitored values of the one or more characteristic heart parameters and a system comprising an intravascular blood pump for percutaneous insertion into a patient's blood vessel and the control device of claim 26, wherein the blood pump is a low inertia device.
However, attention is drawn to the Spanier reference. Spanier teaches an intravascular rotary blood pump having one or more pressure sensors for measuring pressures within the patient's vascular system which are important for operating the blood pump and/or for assessing the patient's state of health ([0001]). Fig. 1 shows a schematic view of the intravascular blood pump inserted into the left ventricle, and transversing the aortic valve into the ascending aorta (an intravascular blood pump, a system comprising an intravascular blood pump for percutaneous insertion into a patient's blood vessel). As seen in more detail in Fig. 3, the pumping device 50 includes a drive shaft 57 protruding from the motor section 51 into the pump section 52, which drives an impeller 58 by means of which, during operation of the blood pump, blood is sucked through the blood pass-through openings 54 at the distal end of the flexible flow cannula 53 and ejected proximally of the impeller 58 through the blood flow-through openings 56 ([0029]) (wherein the blood pump is a low inertia device). The device also includes two optical pressure sensor whose sensor heads 30 and 60 are located externally on the housing of the pump section 52, on the one hand, and externally on the suction inlet 54, on the other hand. These sensors allow measurement of both the aortic pressure by means of the sensor head 60 and the ventricular pressure by means of the sensor head 30 and make possible, in addition to the actual pressure signal, e.g. a contractility measurement by which the recovery of the heart is measured, as well as the establishment of the pressure difference which is used for computing the flow of the pumping device 50 ([0026]). Using these sensors, the ventricular pressure can be detected in a targeted manner with high time resolution (up to 250 Hz). There can be detected therefrom the heart recovery in the form of the cardiac contractility or the passive cardiac wall stress indirectly by measuring the relaxation rate (~onset of diastolic filling phase) in the form of the pressure-based diastole. Moreover, there can be detected the end-diastolic filling pressures, so that blood can also be removed with the pump as required, avoiding high wall stresses at high end-diastolic pressures, which stand in the way of heart recovery ([0016]). The pressure transmitted by the sensor heads 30 and 60 is converted into electrical signals in the evaluation device 100 and displayed e.g. on a display screen 101 ([0025]) (identify a trend of the monitored values of the one or more characteristic heart parameters).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to configure the artificial heart control device taught by Nishimura for use with the low inertia intravascular rotary blood pump capable of measuring and trending both aortic pressure and ventricular pressures taught by Spanier for the purpose of making possible a contractility measurement by which the recovery of the heart is measured.
Claim(s) 28, 30, 40, 42-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishimura in view of Spanier as applied to claim 26 and 38 above, and further in view of Medvedev (2005/0215843).
With regard to claim 28, 30, & 40, 42-43 Nishimura in view of Spanier teaches the control device of claim 26 and the control device of claim 38.
Nishimura in view of Spanier does not teach
wherein the first controller is further configured to determine the speed command signal npumpset(t) based on a difference ΔQ between the blood flow command signal Qpumpset(t)) and the blood flow Qpump(t),
wherein the first controller and the second controller are part of a cascade control system, in which the first controller is an outer controller and the second controller is an inner controller,
wherein the one or more characteristic heart parameters are at least one of: arterial pressure pulsatility AOP|max−AOP|min, mean arterial pressure, heart contractility dLVP(t)/dt|max, heart relaxation dLVP(t)/dt|min, and heart rate HR.
wherein the control device is configured to calculate the blood flow Qpump(t), and
wherein the control device is configured to determine the blood flow Qpump(t) using a look-up table which represents a relationship between the blood flow Qpump(t), the drive speed npump(t), and at least one of a pressure difference ΔPpump(t) between the blood flow outlet and the blood flow inlet and a drive current Ipump(t) supplied to the drive unit.
However, attention is drawn to the Medvedev reference. Medvedev teaches a method and system for controlling the operation of a blood pump ([0002]). The system is described with reference to a Left Ventricular Assist Device (LVAD) but the principles of the invention can be applied to any type of blood pump in which it is desirable to control the operation of the pump in accordance with the patient's activity level ([0013]). To control the pump flow, Medvedev teaches a feedback look (Fig.s 2 and 3B) where a target flow rate (Qtartget) is determined, and compared to a calculated actual flow rate (Q). The actual flow rate Q is determined from current flow to an electric motor driving the pump, and the speed N of the pump. The speed N of the pump is adjusted, based on the difference between the target pump flow rate Qtarget and the actual flow rate Q (based a difference ΔQ between the blood flow command signal Qpumpset(t)) and the blood flow Qpump(t)) ([0017]). FIG. 1 is a block diagram of an exemplary LVAD system incorporating the principles of the present invention. Although the speed and current signals are shown as emanating from the pump itself, the signals can be provided from sensors in any appropriate location and/or configuration. the signal lines 316 and 318 should be viewed as representing information that is obtained from the operation of the pump and/or its driving motor to derive speed and current data ([0014). In response to this input data, the controller 322 produces an output signal 320 (configured to determine the speed command signal npumpset(t)) that regulates the speed of the pump 310 ([0015]).
The specification of the instant application describes a cascade control system as one in which “outer controller may be embedded in outer control loop and may regulate the blood flow generated by the blood pump by comparing the blood flow command signal with the generated blood flow and by setting the set-point of an inner control loop” and “The inner controller is part of the inner control loop and may control the speed of the blood pump by adjusting the motor current accordingly” ([0028]). Informed by this information, step 104 in Fig. 2 and Qtarget as taught by Medvedev read on the outer control loop, and step 106 of Fig. 1 and output signal 320 as taught by Medvedev read on the inner control loop. Therefore Medvedev teaches the first controller and the second controller are part of a cascade control system, in which the first controller is an outer controller and the second controller is an inner controller.
To determine target flow rate, Medvedev teaches determining the ratio of the mean pump calculated heart rate and the speed and using that ratio as the argument of a function to determine Qtarget ([0025]). The motor current waveform or the pump flow rate is analyzed to determine the heart rate of the patient ([0022] (wherein the one or more characteristic heart parameters are at least one of: heart rate). Medvedev also teaches that actual flow rate Q is determined from current flow to an electric motor driving the pump, and the speed N of the pump ([0017] (The control device of claim 26, wherein the control device is configured to calculate the blood flow Qpump(t))and that a flow rate Q of the pump is calculated on the basis of empirically determined relationships between flow, motor electrical current and motor speed for a given pump ([0022]) (the control device is configured to determine the blood flow Qpump(t) using a look-up table which represents a relationship between the blood flow Qpump(t), the drive speed npump(t), and at least one of a drive current Ipump(t) supplied to the drive unit).
Medvedev explains that their control system is based on a ratio of the patient's heart rate to a function of the pump's speed. The patient's activity and a required cardiac assist level can be derived from the heart beat rate of the patient and the rotational speed of the pump, which serves as indirect feedback of systemic afterload ([0006]), and allows that device to provide assistance that best meets that patient’s needs ([0026]) in accordance with the patient’s activity level while putting in place safeguards that mitigate the effects of acting on false or incorrect heart rate values and preventing complete ventricular unloading ([0019]-[0020]).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to implement a cascade control system, monitor heart rate, determine a speed command signal based on the difference between an actual flow and a target flow, and determine flow based on a lookup table relating flow, pump speed, and drive current, taught by Medvedev to the artificial heart control device taught by Nishimura in view of Spanier for the purpose of controlling the device based on a ratio of the patient's heart rate to a function of the pump's speed, which can serve as indirect feedback of systemic afterload.
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishimura in view of Spanier as applied to claim 26 above, and further in view of Rosenberg et al. (2015/0306290 hereinafter Rosenberg).
With regard to claim 37 Nishimura in view of Spanier teaches the control device of claim 26.
Nishimura in view of Spanier does not teach wherein the control device is configured to operate the blood pump in a zero-flow control mode periodically or randomly.
However, attention is drawn to the Rosenberg reference. Rosenberg teaches an LVAD that includes independent sensors for measuring at least one of ventricular pressure and volume ([0011]) that can adjust pump speed based on the results of those measurements ([0105]). Rosenberg explains that evaluation of ventricular function is essential to determine myocardial recovery and weaning from pump support. End-systolic elastance (Ees) and the end-diastolic pressure volume relationship (EDPVR) are the gold standards for assessing native heart systolic and diastolic function, respectively. Conventional methods of assessment rely on current or flow measurements and the inverse calculation of ventricular pressure and volume that requires multiple assumptions and are not able to assess diastolic function. Rosenberg teaches the use of their device to measure the pressure-volume relationship of the native ventricle directly, which will enable the use of Ees and EDPVR to assess ventricular function ([0107]).
Rosenberg explains that through the use of a previously developed single-beat methods to assess Ees without the need for serial pressure-volume data, Ees and EDPVR are obtained periodically from the pressure-volume loop data, and improvement in systolic and diastolic function are determined relative to the baseline level. To minimize variability due to pump support, the pump speed will be fixed during baseline evaluation and all subsequent functional assessments (wherein the control device is configured to operate the blood pump in a zero-flow control mode periodically). By providing a real-time estimate of myocardial functional improvement, clinicians will be able to evaluate and optimize unloading strategies in order to enhance recovery and device weaning ([0109]).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to apply operating the control device periodically as taught by Rosenberg to the control device taught by Nishimura in view of Spanier for the purpose of minimize variability due to pump support while determining myocardial recovery and weaning from pump support.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
EP 1565231 B1: ROTARY BLOOD PUMP DIAGNOSTICS AND CARDIAC OUTPUT CONTROLLER
Field of Invention: This disclosure relates to a pump controller and method of operating same. More particularly, the invention relates to a rotary blood pump controller and method for real time control of the pump to give optimum performance to the patient benefitting from the pump and to give diagnostic feed back to those monitoring the patient.
Description [0038]: A signal 94 or output 94 from the setting step 92 may provide an input 94 to a controller 96. In general, a controller 96, may be a physiological flow controller, a surrogate therefor, or the like. That is, a controller 96 may implement a model for curve fitting in accordance with the present invention relating a desired set point 94 or setting output 94 to the operational parameters of a motor 104. Accordingly, the controller 96 may provide a map, an equation, a model, or other solution relating a physiological parameter 94 resulting from the setting 92 desired, to an input 98 required by a controller 100 for controlling the speed, current, voltage, or the like corresponding to a motor 104 (e.g. input values). Accordingly, the controller 100 provides an output 102 effective to control the motor 104. In general, a motor 104 may be a motive drive 26 of any particular type. Typically, an electric motor 104 may operate effectively. In a clinical environment, pneumatic, hydraulic, and other types of motors 104 may provide other advantages, and may be used accordingly.
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/W.P.A./Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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