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 Claims
Claims 1-9 and 21-31 are rejected. Claims 10-20 are canceled.
Response to Arguments
Claim Rejections - 35 USC § 103
Applicant's arguments filed 4/8/26 have been fully considered but they are not persuasive.
Applicant asserts that the sensor of Higgins is not fixedly connected to the housing at a non-zero angle. However, the Examiner disagrees. In Fig. 6A of Higgins, the pressure sensor 202 is attached to the inside of the housing. ¶42 additionally recites that the distal sensor 202 may be operatively attached to the inlet. The pressure sensor is disposed at a non-zero angle. In Fig. 6A, an imaginary longitudinal axis between the proximal and distal sections, 202 is at an angle to that line.
Applicant additionally asserts that Higgins is silent regarding the pressure sensor being disposed within an internal chamber of the housing. However, the Examiner disagrees. In Fig. 6A of Higgins, pressure sensor 202 is located inside the internal chamber of the housing.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claims 1, 21, and 28 were amended to recite “a pressure sensor fixedly coupled to the housing.” There appears to support for the pressure sensor being coupled to the housing. However, the original claims, specification, and drawings do not provide support for “fixedly.”
Claims 27-28 were amended to recite “a plurality of outlet windows interposed between a plurality of struts circumferentially around the housing.” There appears to support for “wherein the housing further includes a plurality of outlet apertures defining the outlet and a plurality of struts disposed between the plurality of outlet apertures” (¶25). However, the original claims, specification, and drawings do not provide support for “windows” and “circumferentially.”
Claim Rejections - 35 USC § 103
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.
Claims 1-6, 9, 21-23, and 25-30 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval (US 20220184375 filed on 2/28/22 as cited in the IDS) in view of Higgins (US 20200030510 filed on 7/29/19 as cited in the IDS).
Regarding claim 1, Tuval teaches a percutaneous circulatory support device, comprising: a housing (¶163-pump-outlet tube 24) comprising an inlet (¶163-the pump-outlet tube typically defines one or more blood inlet openings 108), an outlet (¶163-the pump-outlet tube defines one or more blood outlet openings 109), a proximal end portion (¶163-proximal section 106 of the pump-outlet tube), a distal end portion (¶163-distal end 32 of the pump-outlet tube), and a longitudinal axis extending between the proximal end portion and the distal end portion (¶170-blood to flow out of the blood outlet openings along flow lines that are substantially parallel with the longitudinal axis of tube 24 at the location of the blood outlet openings; Fig. 1B); an impeller disposed within the housing (¶163-an impeller 50 is disposed within a distal section 102 of pump-outlet tube 24), the impeller configured to rotate relative to the housing to cause blood to flow into the inlet, through the housing, and out of the outlet (¶80-drive the impeller to pump blood from a distal end of the impeller to a proximal end of the impeller, by rotating the impeller in a given direction of rotation); a motor operably coupled to the impeller (¶80-a motor that is configured to drive the impeller), the motor configured to rotate the impeller relative to the housing (¶80-a motor that is configured to drive the impeller to pump blood from a distal end of the impeller to a proximal end of the impeller, by rotating the impeller in a given direction of rotation); and a pressure sensor (¶315-a pressure sensor 216 (illustrated schematically in FIG. 1A) measures pressure of blood within the ventricular blood-pressure-measurement tube. Typically, by measuring pressure of blood within the left ventricular blood-pressure-measurement tube, the pressure sensor thereby measures the subject's blood pressure outside tube 24 (i.e., left ventricular blood pressure)).
While Tuval teaches a pressure sensor (¶315-a pressure sensor 216 (illustrated schematically in FIG. 1A) measures pressure of blood within the ventricular blood-pressure-measurement tube. Typically, by measuring pressure of blood within the left ventricular blood-pressure-measurement tube, the pressure sensor thereby measures the subject's blood pressure outside tube 24 (i.e., left ventricular blood pressure)), Tuval does not explicitly teach the pressure sensor fixedly coupled to the housing, and disposed at a non-zero angle relative to the longitudinal axis, the pressure sensor disposed within an internal chamber of the housing.
Higgins relates generally to an intravascular blood pump comprising a pump assembly without a flow inducer or diffuser, and proximal and distal flow rate or pressure sensors (Abstract). Higgins further teaches the invention using the following step:
a pressure sensor fixedly coupled to the housing (Fig. 6A-pressure sensor 202 attached to the inside of the housing; ¶42-the distal sensor 202 may be operatively attached to the inlet) and disposed at a non-zero angle relative to the longitudinal axis (Fig. 6A-imaginary longitudinal axis between the proximal and distal sections, 202 is at an angle to that line; ¶41- at least one distal sensor 202, which may comprise a pressure sensor), the pressure sensor disposed within an internal chamber of the housing (Higgins, Fig. 6A-pressure sensor 202 located inside the internal chamber of the housing; ¶41).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include the pressure sensor fixedly coupled to the housing, and disposed at a non-zero angle relative to the longitudinal axis, the pressure sensor disposed within an internal chamber of the housing of Higgins in order to allow for LVDP pressure sensing and measurement to determining offloading of the ventricle as well as the flow rate out of the left ventricle (Higgins, ¶38).
Regarding claim 2, the combination of Tuval and Higgins teaches the percutaneous circulatory support device of Claim 1, wherein the housing further comprises an aperture coupled to the internal chamber (Higgins, ¶26-outflow apertures 10 on the right side of the device).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include wherein the housing further comprises an aperture coupled to the internal chamber of Higgins in order to allow for LVDP pressure sensing and measurement to determining offloading of the ventricle as well as the flow rate out of the left ventricle (Higgins, ¶38).
Regarding claim 3, the combination of Tuval and Higgins teaches the percutaneous circulatory support device of Claim 2, wherein the aperture is a transversely-facing aperture (Higgins, Fig. 6B-imaginary longitudinal axis between the proximal and distal sections, the inlet and outlet flow apertures would not be parallel to that line; Fig. 6A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include wherein the aperture is a transversely-facing aperture of Higgins in order to be located within the patient’s aorta (Higgins, ¶43).
Regarding claim 4, the combination of Tuval and Higgins teaches the percutaneous circulatory support device of Claim 2, further comprising a sensor mount disposed within the internal chamber and coupled to the pressure sensor (Higgins, ¶43-at least one proximal pressure or flow rate sensor 206 may be mounted within the blood pump sheath; Fig. 6A-pressure sensor 206 inside the housing).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include a sensor mount disposed within the internal chamber and coupled to the pressure sensor of Higgins in order to allow for LVDP pressure sensing and measurement to determining offloading of the ventricle as well as the flow rate out of the left ventricle (Higgins, ¶38).
Regarding claim 5, the combination of Tuval and Higgins teaches the percutaneous circulatory support device of Claim 2, further comprising a sensor cable coupled to the pressure sensor (Higgins, ¶44-the electrical lead 208 P, 208 D for both sensors 206 , 204 may run from an externally located power source and the controller through the sheath as shown, along the lumen created outside the drive shaft when the drive shaft is translated through the sheath).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include a sensor cable coupled to the pressure sensor of Higgins in order for operative connection and communication with the external power source and the controller and being adapted to transmit pressure or flow rate data to the controller (Higgins, ¶44).
Regarding claim 6, the combination of Tuval and Higgins teaches the percutaneous circulatory support device of Claim 5, wherein the aperture is a transversely-facing aperture (Higgins, Fig. 6B-imaginary longitudinal axis between the proximal and distal sections, the inlet and outlet flow apertures would not be parallel to that line; Fig. 6A), the housing further comprises a proximally-facing aperture coupled to the internal chamber (Fig. 6B-shows the inlet flow and outlet flow, then looking at Fig. 6A-the outlet flow aperture is at the proximal section inside the sheath; ¶26), and the sensor cable extends through the proximally-facing aperture (Higgins, ¶44-the electrical lead 208 P, 208 D for both sensors 206 , 204 may run from an externally located power source and the controller through the sheath as shown, along the lumen created outside the drive shaft when the drive shaft is translated through the sheath; Fig. 6A-sensor 202 is on the proximal side).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include wherein the aperture is a transversely-facing aperture, the housing further comprises a proximally-facing aperture coupled to the internal chamber, and the sensor cable extends through the proximally-facing aperture of Higgins in order for operative connection and communication with the external power source and the controller and being adapted to transmit pressure or flow rate data to the controller (Higgins, ¶44).
Regarding claim 9, the combination of Tuval and Higgins teaches the percutaneous circulatory support device of Claim 1, wherein a direction perpendicular to a sensing membrane of the pressure sensor is disposed at the non-zero angle relative to the longitudinal axis (Higgins, Fig. 6A-imaginary longitudinal axis between the proximal and distal sections, 202 is at an angle to that line; ¶41- at least one distal sensor 202, which may comprise a pressure sensor; Fig. 6A-there would be a non-zero angle from a perpendicular axis through 202 and the longitudinal axis through the proximal and distal sections).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include wherein a direction perpendicular to a sensing membrane of the pressure sensor is disposed at the non-zero angle relative to the longitudinal axis of Higgins in order to allow for LVDP pressure sensing and measurement to determining offloading of the ventricle as well as the flow rate out of the left ventricle (Higgins, ¶38).
Regarding claim 21, Tuval teaches a percutaneous circulatory support device, comprising: a housing (¶163-pump-outlet tube 24) comprising an inlet (¶163-the pump-outlet tube typically defines one or more blood inlet openings 108), an outlet (¶163-the pump-outlet tube defines one or more blood outlet openings 109), a proximal end portion (¶163-proximal section 106 of the pump-outlet tube), a distal end portion (¶163-distal end 32 of the pump-outlet tube), and a longitudinal axis extending between the proximal end portion and the distal end portion (¶170-blood to flow out of the blood outlet openings along flow lines that are substantially parallel with the longitudinal axis of tube 24 at the location of the blood outlet openings; Fig. 1B); an impeller disposed within the housing (¶163-an impeller 50 is disposed within a distal section 102 of pump-outlet tube 24), the impeller configured to rotate relative to the housing to cause blood to flow into the inlet, through the housing, and out of the outlet (¶80-drive the impeller to pump blood from a distal end of the impeller to a proximal end of the impeller, by rotating the impeller in a given direction of rotation); a motor operably coupled to the impeller (¶80-a motor that is configured to drive the impeller), the motor configured to rotate the impeller relative to the housing (¶80-a motor that is configured to drive the impeller to pump blood from a distal end of the impeller to a proximal end of the impeller, by rotating the impeller in a given direction of rotation); and a pressure sensor (¶315-a pressure sensor 216 (illustrated schematically in FIG. 1A) measures pressure of blood within the ventricular blood-pressure-measurement tube. Typically, by measuring pressure of blood within the left ventricular blood-pressure-measurement tube, the pressure sensor thereby measures the subject's blood pressure outside tube 24 (i.e., left ventricular blood pressure)).
While Tuval teaches a pressure sensor (¶315-a pressure sensor 216 (illustrated schematically in FIG. 1A) measures pressure of blood within the ventricular blood-pressure-measurement tube. Typically, by measuring pressure of blood within the left ventricular blood-pressure-measurement tube, the pressure sensor thereby measures the subject's blood pressure outside tube 24 (i.e., left ventricular blood pressure)), Tuval does not explicitly teach a chamber extending along a side wall of the housing, a distal end of the chamber comprising a first transverse-facing aperture; and a pressure sensor fixedly coupled to the housing within the chamber at a non-zero angle relative to the longitudinal axis and disposed at a non-zero angle relative to the longitudinal axis.
Higgins teaches a chamber extending along a side wall of the housing (Fig. 6A- there is an inside chamber that touches the side walls of the housing), a distal end of the chamber comprising a first transverse-facing aperture (Fig. 6A-on the labeled distance side, inlet is an aperture allowing blood inside); and a pressure sensor fixedly coupled to the housing (Fig. 6A-pressure sensor 202 attached to the inside of the housing; ¶42-the distal sensor 202 may be operatively attached to the inlet) within the chamber at a non-zero angle relative to the longitudinal axis and disposed at a non-zero angle relative to the longitudinal axis (Fig. 6A-imaginary longitudinal axis between the proximal and distal sections, 202 is at an angle to that line; ¶41-at least one distal sensor 202, which may comprise a pressure sensor; Fig. 6A-pressure sensor 202 located inside the internal chamber of the housing; ¶41).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include a chamber extending along a side wall of the housing, a distal end of the chamber comprising a first transverse-facing aperture; and a pressure sensor fixedly coupled to the housing within the chamber at a non-zero angle relative to the longitudinal axis and disposed at a non-zero angle relative to the longitudinal axis of Higgins in order to allow for LVDP pressure sensing and measurement to determining offloading of the ventricle as well as the flow rate out of the left ventricle (Higgins, ¶38).
Regarding claim 22, the combination of Tuval and Higgins teaches the percutaneous circulatory support device of claim 21, further comprising a sensor housing coupled to the pressure sensor (Higgins, Fig. 6A-pressure sensor 202 attached to the inside of the housing; ¶42-the distal sensor 202 may be operatively attached to the inlet).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include a sensor housing coupled to the pressure sensor of Higgins in order to allow for LVDP pressure sensing and measurement to determining offloading of the ventricle as well as the flow rate out of the left ventricle (Higgins, ¶38).
Regarding claim 23, the combination of Tuval and Higgins teaches the percutaneous circulatory support device of claim 22, further comprising a sensor cable coupled to the pressure sensor (Higgins, ¶44-204 may run from an externally located power source and the controller through the sheath as shown, along the lumen created outside the drive shaft when the drive shaft is translated through the sheath. Thus, sensors 202 , 204 are in operative connection and communication with the external power source and the controller and adapted to transmit pressure or flow rate data to the controller; Fig. 6A-wire 204 connected to pressure sensor 202).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include a sensor cable coupled to the pressure sensor of Higgins in order to transmit pressure or flow rate data to the controller (Higgins, ¶44).
Regarding claim 25, the combination of Tuval and Higgins teaches the percutaneous circulatory support device of claim 23, wherein a proximal end of the chamber comprises a second transverse-facing aperture (Higgins, Fig. 6A-on the labeled proximal side, outlet is an aperture allowing blood to exit; Fig. 6B-outlet flow).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include wherein a proximal end of the chamber comprises a second transverse-facing aperture of Higgins in order for the mechanical assist device to pump blood in a patient (Higgins, ¶25).
Regarding claim 26, the combination of Tuval and Higgins teaches the percutaneous circulatory support device of claim 25, wherein the sensor cable extends proximally through the chamber and out of the second transverse-facing aperture (Higgins, ¶44-the electrical lead 208 P, 208 D for both sensors 206 , 204 may run from an externally located power source and the controller through the sheath as shown, along the lumen created outside the drive shaft when the drive shaft is translated through the sheath; Fig. 6B-the electrical lead runs from the proximal side and the distal side).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include wherein the sensor cable extends proximally through the chamber and out of the second transverse-facing aperture of Higgins in order for operative connection and communication with the external power source and the controller and adapted to transmit pressure or flow rate data to the controller (Higgins, ¶44).
Regarding claim 27, the combination of Tuval and Higgins teaches the percutaneous circulatory support device of claim 21, wherein the outlet comprises a plurality of outlet windows disposed circumferentially around the housing (Tuval, ¶182-struts 37 of the frame pass through junctions 35; ¶275-pump-outlet tube 24 is placed around the outside of the frame. For some applications, in order to mold pump-outlet tube 24 to conform with the struts of frame 34), and a plurality of struts each disposed between adjacent outlet windows (Tuval, Fig. 2; ¶182-struts 37 of the frame pass through junctions 35; ¶274-pump-outlet tube 24 is shaped to conform with the struts of frame 34).
Regarding claim 28, Tuval teaches a percutaneous circulatory support device, comprising: a housing (¶163-pump-outlet tube 24) comprising an inlet (¶163-the pump-outlet tube typically defines one or more blood inlet openings 108), an outlet (¶163-the pump-outlet tube defines one or more blood outlet openings 109), a proximal end portion (¶163-proximal section 106 of the pump-outlet tube), a distal end portion (¶163-distal end 32 of the pump-outlet tube), and a longitudinal axis extending between the proximal end portion and the distal end portion (¶170-blood to flow out of the blood outlet openings along flow lines that are substantially parallel with the longitudinal axis of tube 24 at the location of the blood outlet openings; Fig. 1B); wherein the outlet comprises a plurality of outlet windows interposed between a plurality of struts circumferentially around the housing (¶182-struts 37 of the frame pass through junctions 35; ¶275-pump-outlet tube 24 is placed around the outside of the frame. For some applications, in order to mold pump-outlet tube 24 to conform with the struts of frame 34); an impeller disposed within the housing ¶163-an impeller 50 is disposed within a distal section 102 of pump-outlet tube 24), the impeller configured to rotate relative to the housing to cause blood to flow into the inlet, through the housing, and out of the outlet (¶80-drive the impeller to pump blood from a distal end of the impeller to a proximal end of the impeller, by rotating the impeller in a given direction of rotation); a motor operably coupled to the impeller (¶80-a motor that is configured to drive the impeller), the motor configured to rotate the impeller relative to the housing (¶80-a motor that is configured to drive the impeller to pump blood from a distal end of the impeller to a proximal end of the impeller, by rotating the impeller in a given direction of rotation); a chamber extending along one of the plurality of struts (Fig. 2-cylindrical portion 38 extends with strut 37); and a pressure sensor (¶315-a pressure sensor 216 (illustrated schematically in FIG. 1A) measures pressure of blood within the ventricular blood-pressure-measurement tube. Typically, by measuring pressure of blood within the left ventricular blood-pressure-measurement tube, the pressure sensor thereby measures the subject's blood pressure outside tube 24 (i.e., left ventricular blood pressure)).
While Tuval teaches a pressure sensor (¶315-a pressure sensor 216 (illustrated schematically in FIG. 1A) measures pressure of blood within the ventricular blood-pressure-measurement tube. Typically, by measuring pressure of blood within the left ventricular blood-pressure-measurement tube, the pressure sensor thereby measures the subject's blood pressure outside tube 24 (i.e., left ventricular blood pressure)), Tuval does not explicitly teach a pressure sensor fixedly coupled within the chamber at a non-zero angle relative to the longitudinal axis.
Higgins teaches a pressure sensor fixedly coupled within the chamber at a non-zero angle relative to the longitudinal axis (Fig. 6A-pressure sensor 202 attached to the inside of the housing; ¶42-the distal sensor 202 may be operatively attached to the inlet; Fig. 6A-imaginary longitudinal axis between the proximal and distal sections, 202 is at an angle to that line; ¶41-at least one distal sensor 202, which may comprise a pressure sensor; Fig. 6A-pressure sensor 202 located inside the internal chamber of the housing; ¶41).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include a pressure sensor fixedly coupled within the chamber at a non-zero angle relative to the longitudinal axis of Higgins in order to allow for LVDP pressure sensing and measurement to determining offloading of the ventricle as well as the flow rate out of the left ventricle (Higgins, ¶38).
Regarding claim 29, the combination of Tuval and Higgins teaches the percutaneous circulatory support device of claim 28, wherein a distal end of the chamber comprises a first transverse-facing aperture (Higgins, Fig. 6A-on the labeled distance side, inlet is an aperture allowing blood inside) and a proximal end of the chamber comprises a transverse-facing aperture (Higgins, Fig. 6A-the outflow end (proximal) on the right side).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include wherein a distal end of the chamber comprises a first transverse-facing aperture and a proximal end of the chamber comprises a transverse-facing aperture of Higgins in order to allow for LVDP pressure sensing and measurement to determining offloading of the ventricle as well as the flow rate out of the left ventricle (Higgins, ¶38).
Regarding claim 30, the combination of Tuval and Higgins teaches the percutaneous circulatory support device of claim 29, wherein a sensor cable extends proximally from the pressure sensor, through the chamber and out of the second transverse-facing aperture (Higgins, ¶44-204 may run from an externally located power source and the controller through the sheath as shown, along the lumen created outside the drive shaft when the drive shaft is translated through the sheath. Thus, sensors 202 , 204 are in operative connection and communication with the external power source and the controller and adapted to transmit pressure or flow rate data to the controller; Fig. 6A-wire 204 connected to pressure sensor 202 and wire 204 exits out the proximal end of the chamber).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include wherein a sensor cable extends proximally from the pressure sensor, through the chamber and out of the second transverse-facing aperture of Higgins in order to transmit pressure or flow rate data to the controller (Higgins, ¶44).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Tuval in view of Higgins as applied to claim 2 above, and further in view of Muller (US 20180326131 filed on 6/27/18).
Regarding claim 7, the combination of Tuval and Higgins teaches the percutaneous circulatory support device of Claim 2. However, the combination of Tuval and Higgins does not teach wherein the housing further comprises a plurality of outlet apertures defining the outlet and a plurality of struts disposed between the plurality of outlet apertures, and the pressure sensor is carried by one of the plurality of struts.
Muller teaches wherein the housing further comprises a plurality of outlet apertures defining the outlet (Fig. 18B-a plurality of outlet apertures 522) and a plurality of struts disposed between the plurality of outlet apertures (Fig. 18B-structures surrounding the holes), and the pressure sensor is carried by one of the plurality of struts (¶128-the first proximal sensor location 521A can be disposed nearer the outlets 522; Fig. 18B-pressure sensor 521A is carried on an arm of the device).
Muller is directed to a catheter pump for mechanical circulatory support of a heart, and related components, systems and methods. In particular, this application is directed to sensors used in catheter pumps (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include wherein the housing further comprises a plurality of outlet apertures defining the outlet and a plurality of struts disposed between the plurality of outlet apertures, and the pressure sensor is carried by one of the plurality of struts of Muller in order to provide more accurate fluid measurements, which can be advantageous in estimating the position and/or orientation of the impeller housing relative to the anatomy (Muller, ¶128).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tuval in view of Higgins as applied to claim 2 above, and further in view of Spanier (US 20150141842 filed on 4/25/13).
Regarding claim 8, the combination of Tuval and Higgins teaches the percutaneous circulatory support device of Claim 2. However, the combination of Tuval and Higgins does not teach wherein the pressure sensor comprises one of an optical pressure sensor and an electrical pressure sensor.
Spanier teaches wherein the pressure sensor comprises one of an optical pressure sensor and an electrical pressure sensor (¶25-optical pressure sensor)
Spanier relates to 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 (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include wherein the pressure sensor comprises one of an optical pressure sensor and an electrical pressure sensor of Spanier in order to shift relative to the pumping device 50 within said hose or tubelet upon changes of bend of the flow cannula 53 (Spanier, ¶31).
Claims 24 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval in view of Higgins as applied to claim 2 above, and further in view of Nunez (US 20180064860 filed on 9/5/17).
Regarding claim 24, the combination of Tuval and Higgins teaches the percutaneous circulatory support device of claim 23, wherein the chamber comprises a sensor mount therein (Higgins, ¶43-at least one proximal pressure or flow rate sensor 206 may be mounted within the blood pump sheath; Fig. 6A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include wherein the chamber comprises a sensor mount therein of Higgins in order to allow for LVDP pressure sensing and measurement to determining offloading of the ventricle as well as the flow rate out of the left ventricle (Higgins, ¶38).
However, the combination of Tuval and Higgins does not teach the sensor mount comprising a central opening configured to receive the sensor cable.
Nunez teaches the sensor mount comprising a central opening configured to receive the sensor cable (¶55-pressure sensor 260 is mounted to transverse wall 250 so that sensing element 261 is located at the distal end of a bore 246 and is exposed to blood flowing therethrough. A conductor 264 for supplying power and transmitting signals is connected to pressure sensor 240 and extends through transverse wall 250 and sidewall 248 of the cannula 240; Fig. 2).
Nunez relates to blood pumps usable as implantable ventricular assist devices and, more particularly, to an improved blood pump design with integrated sensors (¶3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include the sensor mount comprising a central opening configured to receive the sensor cable of Nunez in order to supply power and transmit signals (Nunez, ¶55).
Regarding claim 31, the combination of Tuval and Higgins teaches the percutaneous circulatory support device of claim 30, wherein the chamber comprises a sensor mount therein (Higgins, ¶43-at least one proximal pressure or flow rate sensor 206 may be mounted within the blood pump sheath; Fig. 6A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include wherein the chamber comprises a sensor mount therein of Higgins in order to allow for LVDP pressure sensing and measurement to determining offloading of the ventricle as well as the flow rate out of the left ventricle (Higgins, ¶38).
However, the combination of Tuval and Higgins does not teach the sensor mount comprising a central opening configured to receive the sensor cable.
Nunez teaches the sensor mount comprising a central opening configured to receive the sensor cable (¶55-pressure sensor 260 is mounted to transverse wall 250 so that sensing element 261 is located at the distal end of a bore 246 and is exposed to blood flowing therethrough. A conductor 264 for supplying power and transmitting signals is connected to pressure sensor 240 and extends through transverse wall 250 and sidewall 248 of the cannula 240; Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tuval to include the sensor mount comprising a central opening configured to receive the sensor cable of Nunez in order to supply power and transmit signals (Nunez, ¶55).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20220161021: which relates to mechanical circulatory support systems (¶7).
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 LAURA HODGE whose telephone number is (571) 272-7101. The examiner can normally be reached M-F: 8:00 am-5:00 pm.
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/L.N.H./Examiner, Art Unit 3792 /UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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