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 .
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) 22-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edelman et al. (US 20180078159) 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); and a first sensor 112 positioned within the first portion of the blood pump and configured to generate a first measuring signal representing a left ventricular pressure (LVP) 808 within the left ventricle of the patient (Section 0072, 0123, the pressure sensor 112 can be used to detect whether the pump outlet has passed through the aortic valve 105 into the left ventricle 103 which would only circulate blood within the left ventricle 103 rather than transport blood from the left ventricle 103 to the aorta. 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 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 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 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 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 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 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 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 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 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 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 within the left ventricle of the patient using a first sensor positioned within the first portion of the 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);
However, Edelman 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 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 33, Edelman 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 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 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 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 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 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 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 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 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.
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 filed 1/16/2026 have been fully considered but they are not persuasive. Examiner does find that Poirier discloses from sensors 65 and 75 on the inflow and outflow conduits respectively (Fig. 1, section 0016, Inflow conduit 60 can be configured to receive blood from the heart of a patient e.g., from the left ventricle for a pump providing support for the systemic circulation, or from the right ventricle for a pump providing support to the pulmonary circulation, while outflow conduit 70 can be configured to return blood to the circulatory system of the patient e.g., via the aorta for a pump providing support for the systemic circulation, or via the pulmonary artery for a pump providing support for the pulmonary circulation. 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) and one or more processors 80 configured to: receive the first measuring signal (Fig. 1, section 0016, 0018, 0066, 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).
Conclusion
THIS ACTION IS MADE FINAL. 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 JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796