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 .
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.
Claim(s) 22-28, 30-38, and 40-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edelman et al. (US 20180078159), cited previously, in view of Rosenberg et al. (US 20150306290) and further in view of Poirier (US 20100222635), cited previously.
Regarding claim 22, Edelman discloses a blood pump 10 comprising: a first portion 114 configured to be positioned within a left ventricle 103 of a patient (Fig. 1, section 0068, The heart 102 includes a left ventricle 103, aorta 104, and aortic valve 105. The intravascular heart pump system includes a catheter 106, a motor 108, a pump outlet 110, a cannula 111, a pump inlet 114, and a pressure sensor 112); a second portion 106, 108 coupled to the first portion 114 and configured to extend across an aortic valve 105 of the patient and into an aorta 104 of the patient when the first portion 114 is positioned within the left ventricle 103 of the patient (Fig. 1, section 0068, The cannula 111 is positioned across the aortic valve 105 such that the pump inlet 114 is located within the left ventricle 103 and the pump outlet 110 is located within the aorta 104. This configuration allows the intravascular heart pump system 100 to pump blood from the left ventricle 103 into the aorta 104 to support cardiac output);
However, Edelman does not disclose a first sensor positioned within the first portion of the blood pump such that when the first portion of the blood pump is positioned within the left ventricle of the patient, the first sensor is positioned within the left ventricle of the patient, and wherein the first sensor is configured to generate a first measuring signal representing a left ventricular pressure (LVP) while the first sensor is positioned within the left ventricle of the patient.
Rosenberg discloses a first sensor positioned 12, 19 within the first portion of the blood pump such that when the first portion of the blood pump is positioned within the left ventricle 33 of the patient (Figs. 2-4, section 0026, 0067), the first sensor is positioned within the left ventricle of the patient (Fig. 4), and wherein the first sensor is configured to generate a first measuring signal representing a left ventricular pressure (LVP) (Section 0034, 0036, 0052) while the first sensor 12, 19 is positioned within the left ventricle 33 of the patient (Fig. 4 show device depicted in Figs. 1-2 within the left ventricle of the heart). This allows for proper pressure measurements to be sensed from pressure sensors positioned within the left ventricle for proper control of the blood pump within the heart. Therefore it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Edelman by adding a first sensor positioned within the first portion of the blood pump such that when the first portion of the blood pump is positioned within the left ventricle of the patient, the first sensor is positioned within the left ventricle of the patient, and wherein the first sensor is configured to generate a first measuring signal representing a left ventricular pressure (LVP) while the first sensor is positioned within the left ventricle of the patient as taught by Rosenberg in order to facilitate for proper pressure measurements to be sensed from pressure sensors positioned within the left ventricle for proper control of the blood pump within the heart.
However, Edelman in view of Rosenberg does not specfically disclose one or more processors configured to: receive the first measuring signal; calculate the LVP based on the first measuring signal; and control the blood pump to assist with unloading the left ventricle of the patient based on the calculated LVP. Poirier discloses one or more processors 80 configured to: receive the first measuring signal (section 0016, 0018, 0066, sensor 65 can be positioned on an interior surface of inflow conduit 60, and sensor 75 can be positioned on an interior surface of outflow conduit 70. Sensors 65 and 75 can serve a variety of purposes. Information regarding blood pressure and/or blood flow measured by sensor(s) on a blood pump can be sent to controller); calculate the LVP based on the first measuring signal; and control the blood pump to assist with unloading the left ventricle of the patient based on the calculated LVP (Fig. 2, section 0020, detecting left ventricular pressure in a subject having a blood pump system, via a sensor at an inflow conduit of the blood pump, and increasing, maintaining, or reducing the speed of the blood pump based on the detected inflow conduit pressure. In order to maintain left ventricular pressure within a particular range, the speed can be reduced if the detected left ventricular pressure is less than a lower threshold level (thus increasing the left ventricular pressure), and the speed can be increased if the detected left ventricular pressure is greater than an upper threshold level thus decreasing the left ventricular pressure). This allows for proper LVP signals to be detected and used to control the unload of the left ventricle of the patient. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Edelman in view of Rosenberg by adding ; calculate the LVP based on the first measuring signal; and control the blood pump to assist with unloading the left ventricle of the patient based on the calculated LVP as taught by Poirier in order to facilitate This allows for proper LVP signals to be detected and used to control the unload of the left ventricle of the patient.
Regarding claim 23, Edelman in view of Rosenberg in view of Poirier, specfically Poirier discloses the one or more processors are configured to control a speed of the blood pump such that the LVP within the left ventricle of the patient is maintained at a predetermined set-point value (section 0020).
Regarding claim 24, Edelman in view of Rosenberg in view of Poirier, specfically Edelman discloses the first sensor is a pressure sensor that directly measures the LVP (Section 0123, the left ventricular pressure signal can be generated using a dedicated catheter placed in the left ventricle, a pressure sensor mounted on the inlet side of the pump).
Regarding claim 25, Edelman in view of Rosenberg in view of Poirier, specfically Poirier discloses the left ventricle of the patient is sufficiently unloaded to support the recovery thereof (section 0020).
Regarding claim 26, Edelman in view of Rosenberg in view of Poirier, specfically Poirier discloses the one or more processors are configured to calculate the LVP during a systolic phase of a cardiac cycle of the patient (section 0024, 0027).
Regarding claim 27, Edelman in view of Rosenberg in view of Poirier, specfically Poirier discloses the one or more processors are further configured to calculate a pressure gradient of the LVP during the systolic phase of the cardiac cycle of the patient, and wherein the control of the blood pump is based on the calculated pressure gradient (Fig. 2, section 0020).
Regarding claim 28, Edelman in view of Rosenberg in view of Poirier, specfically Poirier discloses the one or more processors are configured to calculate the LVP during a diastolic phase of a cardiac cycle of the patient (Section 0024).
Regarding claim 30, Edelman in view of Rosenberg in view of Poirier, specfically Poirier discloses the blood pump further comprises a second sensor 75 positioned within the second portion of the blood pump (Fig. 1, section 0016) and configured to generate a second measuring signal representing an aortic pressure (AoP) within the aorta of the patient, wherein the one or more processors are further configured to receive the second measuring signal and calculate the AoP based on the second measuring signal, and wherein the control of the blood pump is further based on the calculated AoP (Section 0053).
Regarding claim 31, Edelman in view of Rosenberg in view of Poirier, specfically Poirier discloses the first sensor 65 is positioned at an inlet 60 of the blood pump, and wherein the second sensor 75 is positioned at an outlet 70 of the blood pump (Fig. 1).
Regarding claim 32, Edelman discloses positioning a first portion 114 of a blood pump within a left ventricle 103 of a patient (Fig. 1, Fig. 1, section 0068, The heart 102 includes a left ventricle 103, aorta 104, and aortic valve 105. The intravascular heart pump system includes a catheter 106, a motor 108, a pump outlet 110, a cannula 111, a pump inlet 114, and a pressure sensor); positioning a second portion 106, 108 of the blood pump across an aortic valve 105 of the patient and into an aorta 104 of the patient when the first portion 114 of the blood pump is positioned within the left ventricle 103 of the patient (Fig. 1, Fig. 1, section 0068, The cannula 111 is positioned across the aortic valve 105 such that the pump inlet 114 is located within the left ventricle 103 and the pump outlet 110 is located within the aorta 104. This configuration allows the intravascular heart pump system 100 to pump blood from the left ventricle 103 into the aorta 104 to support cardiac output), wherein the second portion 106, 108 of the blood pump is coupled to the first portion 114 of the blood pump (Fig. 1); generating a first measuring signal representing a left ventricular pressure (LVP) 808 (Fig. 1, Section 0123, the left ventricular pressure signal can be generated using a dedicated catheter placed in the left ventricle, a pressure sensor mounted on the inlet side of the pump);
However, Edelman does not disclose wherein the first portion of the blood pump includes a first sensor positioned therein, and wherein positioning the first portion of the blood pump within the left ventricle of the patient includes positioning the first sensor within the left ventricle of the patient; generating a first measuring signal representing a left ventricular pressure (LVP) using the first sensor positioned within the left ventricle of the patient.
Rosenberg discloses wherein the first portion of the blood pump includes a first sensor 12, 19 positioned therein, and wherein positioning the first portion of the blood pump within the left ventricle 33 of the patient includes positioning the first sensor 12, 19 within the left ventricle 33 of the patient (Figs. 2-4, section 0026, 0067); generating a first measuring signal representing a left ventricular pressure (LVP) (Section 0034, 0036, 0052) using the first sensor 12, 19 positioned within the left ventricle 33 of the patient (Fig. 4 show device depicted in Figs. 1-2 within the left ventricle of the heart). This allows for proper pressure measurements to be sensed from pressure sensors positioned within the left ventricle for proper control of the blood pump within the heart. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Edelman by adding the first portion of the blood pump includes a first sensor positioned therein, and wherein positioning the first portion of the blood pump within the left ventricle of the patient includes positioning the first sensor within the left ventricle of the patient; generating a first measuring signal representing a left ventricular pressure (LVP) using the first sensor positioned within the left ventricle of the patient as taught by Rosenberg in order to facilitate for proper pressure measurements to be sensed from pressure sensors positioned within the left ventricle for proper control of the blood pump within the heart.
However, Edelman in view of Rosenberg does not specfically disclose calculating the LVP based on the first measuring signal; and controlling the blood pump to assist with unloading the left ventricle of the patient based on the calculated LVP. Poirier discloses one or more processors 80 configured to: receive the first measuring signal (section 0016, 0018, 0066, sensor 65 can be positioned on an interior surface of inflow conduit 60, and sensor 75 can be positioned on an interior surface of outflow conduit 70. Sensors 65 and 75 can serve a variety of purposes. Information regarding blood pressure and/or blood flow measured by sensor(s) on a blood pump can be sent to controller); calculate the LVP based on the first measuring signal; and control the blood pump to assist with unloading the left ventricle of the patient based on the calculated LVP (Fig. 2, section 0020, detecting left ventricular pressure in a subject having a blood pump system, via a sensor at an inflow conduit of the blood pump, and increasing, maintaining, or reducing the speed of the blood pump based on the detected inflow conduit pressure. In order to maintain left ventricular pressure within a particular range, the speed can be reduced if the detected left ventricular pressure is less than a lower threshold level (thus increasing the left ventricular pressure), and the speed can be increased if the detected left ventricular pressure is greater than an upper threshold level thus decreasing the left ventricular pressure). This allows for proper LVP signals to be detected and used to control the unload of the left ventricle of the patient. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Edelman in view of Rosenberg by adding calculating the LVP based on the first measuring signal; and control the blood pump to assist with unloading the left ventricle of the patient based on the calculated LVP as taught by Poirier in order to facilitate This allows for proper LVP signals to be detected and used to control the unload of the left ventricle of the patient.
Regarding claim 33, Edelman in view of Rosenberg in view of Poirier, specfically Poirier discloses controlling the blood pump comprises controlling a speed of the blood pump such that the LVP within the left ventricle of the patient is maintained at a predetermined set-point value (section 0020).
Regarding claim 34, Edelman in view of Rosenberg in view of Poirier, specfically Edelman discloses the first sensor is a pressure sensor that directly measures the LVP (Section 0123, the left ventricular pressure signal can be generated using a dedicated catheter placed in the left ventricle, a pressure sensor mounted on the inlet side of the pump).
Regarding claim 35, Edelman in view of Rosenberg in view of Poirier, specfically Poirier discloses the left ventricle of the patient is sufficiently unloaded to support the recovery thereof (section 0020).
Regarding claim 36, Edelman in view of Rosenberg in view of Poirier, specfically Poirier discloses calculate the LVP during a systolic phase of a cardiac cycle of the patient (section 0024, 0027).
Regarding claim 37, Edelman in view of Rosenberg in view of Poirier, specfically Poirier discloses calculating a pressure gradient of the LVP during the systolic phase of the cardiac cycle of the patient, wherein the blood pump is controlled based on the calculated pressure gradient (Fig. 2, section 0020).
Regarding claim 38, Edelman in view of Rosenberg in view of Poirier, specfically Poirier discloses the LVP is calculated during a diastolic phase of a cardiac cycle of the patient (Section 0024).
Regarding claim 40, Edelman in view of Rosenberg in view of Poirier, specfically Poirier discloses generating a second measuring signal representing an aortic pressure (AoP) within the aorta of the patient using a second sensor positioned within the second portion of the blood pump (Fig. 1, section 0016); and calculating the AoP based on the second measuring signal, wherein the blood pump is controlled based on the calculated LVP and the calculated AoP (section 0053).
Regarding claim 41, Edelman discloses receive a first measuring signal representing a left ventricular pressure (LVP) within a left ventricle of a patient from a first sensor positioned within a first portion of a blood pump (Fig. 1, Section 0123, the left ventricular pressure signal can be generated using a dedicated catheter placed in the left ventricle, a pressure sensor mounted on the inlet side of the pump), wherein the first portion 114 of the blood pump is positioned within the left ventricle 103 of the patient (Fig. 1, section 0068, The heart 102 includes a left ventricle 103, aorta 104, and aortic valve 105. The intravascular heart pump system includes a catheter 106, a motor 108, a pump outlet 110, a cannula 111, a pump inlet 114, and a pressure sensor), wherein the blood pump further comprises a second portion 106, 108 coupled to the first portion 114 (Fig. 1), and wherein the second portion 106, 108 extends across an aortic valve 105 of the patient and into an aorta 104 of the patient (Fig. 1, section 0068, The cannula 111 is positioned across the aortic valve 105 such that the pump inlet 114 is located within the left ventricle 103 and the pump outlet 110 is located within the aorta 104. This configuration allows the intravascular heart pump system 100 to pump blood from the left ventricle 103 into the aorta 104 to support cardiac output);
However, Edelman does not disclose such that the first sensor is positioned within the left ventricle of the patient.
Rosenberg discloses such that the first sensor 12, 19 (Figs. 2-4, section 0026, 0067) is positioned within the left ventricle 33 of the patient (Fig. 4 show device with pressure sensors depicted in Figs. 1-2 within the left ventricle of the heart). This allows for proper pressure measurements to be sensed from pressure sensors positioned within the left ventricle for proper control of the blood pump within the heart. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Edelman by adding the first portion of the blood pump includes a first sensor positioned therein, and wherein positioning the first portion of the blood pump within the left ventricle of the patient includes positioning the first sensor within the left ventricle of the patient; generating a first measuring signal representing a left ventricular pressure (LVP) using the first sensor positioned within the left ventricle of the patient as taught by Rosenberg in order to facilitate for proper pressure measurements to be sensed from pressure sensors positioned within the left ventricle for proper control of the blood pump within the heart.
However, Edelman in view of Rosenberg does not specfically disclose calculate the LVP based on the first measuring signal; and control the blood pump to assist with unloading the left ventricle of the patient based on the calculated LVP. Poirier discloses one or more processors 80 configured to: receive the first measuring signal (section 0016, 0018, 0066, sensor 65 can be positioned on an interior surface of inflow conduit 60, and sensor 75 can be positioned on an interior surface of outflow conduit 70. Sensors 65 and 75 can serve a variety of purposes. Information regarding blood pressure and/or blood flow measured by sensor(s) on a blood pump can be sent to controller); calculate the LVP based on the first measuring signal; and control the blood pump to assist with unloading the left ventricle of the patient based on the calculated LVP (Fig. 2, section 0020, detecting left ventricular pressure in a subject having a blood pump system, via a sensor at an inflow conduit of the blood pump, and increasing, maintaining, or reducing the speed of the blood pump based on the detected inflow conduit pressure. In order to maintain left ventricular pressure within a particular range, the speed can be reduced if the detected left ventricular pressure is less than a lower threshold level (thus increasing the left ventricular pressure), and the speed can be increased if the detected left ventricular pressure is greater than an upper threshold level thus decreasing the left ventricular pressure). This allows for proper LVP signals to be detected and used to control the unload of the left ventricle of the patient. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Edelman in view of Rosenberg by adding calculating the LVP based on the first measuring signal; and control the blood pump to assist with unloading the left ventricle of the patient based on the calculated LVP as taught by Poirier in order to facilitate This allows for proper LVP signals to be detected and used to control the unload of the left ventricle of the patient.
Allowable Subject Matter
Claims 29, 39 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claim(s) 22-41 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.
Conclusion
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796
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