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 1-2, 4-6, and 9-18 are currently amended.
Claim 10 is cancelled.
Claims 20-21 are newly added claims.
Response to Arguments
Applicant’s arguments, see pages 8-12, filed 12/18/2025, with respect to the rejection(s) of
claim(s) 1-19 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gunasekaran.
35 U.S.C. 103:
Regarding claim 1, applicant argues that Hettrick, alone or in combination with the prior art,
does not teach the newly amended claim, specifically, “a controller configured to measure an impedance between the first energy delivery element and the guide catheter energy delivery element when the distal portion of the inner catheter is in the deployed configuration; determine a change in a relative distance between the first energy delivery element and the guide catheter energy delivery element based on the impedance and provide a location of the inner catheter within the renal blood vessel based on the change in the relative distance between the first energy delivery element and the guide catheter energy delivery element.” After further search and consideration, the examiner will now rely on Gunasekaran to teach this limitation (fig. 1A-C; paragraph 25-27, 32, and 47). The elongated member 103 be sized to be slidably positioned within a lumen of the neuromodulation catheter 102. Furthermore, the elongated member 103 may comprise other suitable components and/or configurations, which may be a plurality of energy deliver elements 110a-d. Figure 1A shows an energy delivery element 110a disposed on the distal end of the catheter 102. It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify the extended catheter of Gross with the elongated member from Gunasekaran for the benefit providing more flexible electrode positioning and to allow the operator to manipulate the distal portion to the desired orientation. Furthermore, it would have been obvious to modify the distal portion of the catheter body from Gross to add an energy delivery element from Gunasekaran for the benefit of determining electrode relative distance between the target site and catheter body for optimal stimulation treatment.
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.
Claims 1-7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over GROSS et al. US
Pub.: US 20170007157 A1, hereinafter Gross in view of Gunasekaran et al. US Pub.: US 20190223754 A1, hereinafter Gunasekaran.
Regarding claim 1, Gross teaches a system for renal denervation, comprising (fig. 5; paragraph
300-303):
a guide catheter having a lumen and a guide catheter energy delivery element positioned at a distal portion of the guide catheter, the distal portion of the guide catheter being configured to be intravascularly positioned within a main vessel (fig. 5; paragraph 300-303 and 321); Guide catheter 74 is a sheath. A guide catheter energy delivery element 60 may be positioned anywhere along the elongated shaft, including the distal portion of the guide catheter 74.
an inner catheter positioned within the lumen of the guide catheter and having a plurality of energy delivery elements including a first energy delivery element and a second energy delivery element, a distal portion of the inner catheter being configured to be positioned near a treatment site within a renal blood vessel and transform from a delivery configuration to a deployed configuration (fig. 5; paragraph 300-303); The electrode unit 30, elongated shaft 40, and central shaft 48 make up the inner catheter. Electrode unit 30 comprises four pairs 42 of intrarenal electrodes 44.
and a controller coupled to the renal denervation device and configured to (fig. 5; paragraph 304; control circuitry 70):
However, Gross does not teach a controller configured to measure an impedance between the first energy delivery element and the guide catheter energy delivery element when the distal portion of the inner catheter is in the deployed configuration; determine a change in a relative distance between the first energy delivery element and the guide catheter energy delivery element based on the impedance and provide a location of the inner catheter within the renal blood vessel based on the change in the relative distance between the first energy delivery element and the guide catheter energy delivery element.
Gunasekaran, in the same field of endeavor, teaches a controller configured to measure an impedance between the first energy delivery element and the guide catheter energy delivery element when the distal portion of the inner catheter is in the deployed configuration (fig. 1A-C; paragraph 25-27, 32, and 47). It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.” Figure 1C shows the distal portion of the inner catheter is in the deployed configuration.
determine a change in a relative distance between the first energy delivery element and the guide catheter energy delivery element based on the impedance and provide a location of the inner catheter within the renal blood vessel based on the change in the relative distance between the first energy delivery element and the guide catheter energy delivery element (fig. 1A-C; paragraph 25-27, 32, and 47). The elongated member 103 be sized to be slidably positioned within a lumen of the neuromodulation catheter 102. Furthermore, the elongated member 103 may comprise other suitable components and/or configurations, which may be a plurality of energy deliver elements 110a-d. Figure 1A shows an energy delivery element 110a disposed on the distal end of the catheter 102. It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the extended catheter of Gross with the elongated member from Gunasekaran for the benefit providing more flexible electrode positioning and to allow the operator to manipulate the distal portion to the desired orientation. Furthermore, it would have been obvious to modify the distal portion of the catheter body from Gross to add an energy delivery element from Gunasekaran for the benefit of determining electrode relative distance between the target site and catheter body for optimal stimulation treatment.
Regarding claim 2, Gross in view of Gunasekaran teaches the claimed invention and Gross
further teaches wherein when the inner catheter is in the delivery configuration the inner catheter is substantially within the lumen of the guide catheter and the first energy delivery element is aligned with the guide catheter energy delivery element (fig. 5; paragraph 300-303 and 321); Guide catheter 74 is a sheath. A guide catheter energy delivery element 60 may be positioned anywhere along the elongated shaft, including the distal portion of the guide catheter 74. The electrode unit 30, elongated shaft 40, and central shaft 48 make up the inner catheter. Electrode unit 30 comprises four pairs 42 of intrarenal electrodes 44.
Regarding claim 3, Gross in view of Gunasekaran teaches the claimed invention and Hettrick
further teaches wherein the controller is configured to: calibrate the impedance between the first energy delivery element and the guide catheter energy delivery element when the inner catheter is in the delivery configuration (paragraph 39). The vessel impedance can be measured using (i) a bipolar technique that measures the impedance between any pair of electrodes 110 or between any individual electrode 110 and a reference electrode that is external or internal to the patient (e.g., the dispersive electrode 160 (FIG. 1)), (ii) a quadripolar technique in which the two outer ones of the electrodes 110 (e.g., the most proximally and distally positioned ones of the electrodes 110) are used to drive a constant electrical current while the two inner ones of the electrodes 110 are used to measure the resultant voltage and hence impedance, (iii) or any combination thereof.
Regarding claim 4, Gross in view of Gunasekaran teaches the claimed invention and Hettrick
further teaches wherein when the inner catheter is in the deployed configuration the inner catheter is extended away from the guide catheter and a distal portion of the inner catheter expands to place at least the first energy delivery element at or near the treatment site (fig. 1 and 5; paragraph 301).
However, Gross in view of Gunasekaran does not teach the inner catheter expands into a helical or spiral configuration as applied.
Gunasekaran, in the same field of endeavor, teaches the inner catheter expands into a helical or spiral configuration (fig. 1A-C; paragraph 25-27, 32, and 47). It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.” Figure 1C shows the distal portion of the inner catheter is in the deployed configuration and in a helical spiral.
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 extended catheter of Gross with the elongated member from Gunasekaran for the benefit providing more flexible electrode positioning and to allow the operator to manipulate the distal portion to the desired orientation.
Regarding claim 5, Gross in view of Gunasekaran teaches the claimed invention and
Gunasekaran further teaches wherein the controller is configured to: measure the first impedance between the first energy delivery element and the guide catheter energy delivery element when the inner catheter is in the delivery configuration; measure a second impedance between the first energy delivery element and the guide catheter energy delivery element when the inner catheter is in the deployed configuration; determine a difference between the second impedance and the first impedance; and determine the location of the inner catheter based on the difference (fig. 1A-C; paragraph 25-27, 32, and 47). The elongated member 103 be sized to be slidably positioned within a lumen of the neuromodulation catheter 102. Furthermore, the elongated member 103 may comprise other suitable components and/or configurations, which may be a plurality of energy deliver elements 110a-d. Figure 1A shows an energy delivery element 110a disposed on the distal end of the catheter 102. It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.” Therefore a second impedance is disclosed. The location of the inner catheter may be determined based on this measurement.
Regarding claim 6, Gross in view of Gunasekaran teaches the claimed invention and
Gunasekaran further teaches wherein the controller is configured to: measure the first impedance between the first energy delivery element and the guide catheter energy delivery element when the inner catheter is in the delivery configuration; measure a second impedance between the first energy delivery element and the guide catheter energy delivery element when the inner catheter is in the deployed configuration; and measure a third impedance between the second energy delivery element and the guide catheter energy delivery element when the inner catheter is in the deployed configuration (fig. 1A-C; paragraph 25-27, 32, and 47). The elongated member 103 be sized to be slidably positioned within a lumen of the neuromodulation catheter 102. Furthermore, the elongated member 103 may comprise other suitable components and/or configurations, which may be a plurality of energy deliver elements 110a-d. Figure 1A shows an energy delivery element 110a disposed on the distal end of the catheter 102. It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.” Therefore a third impedance is disclosed. The location of the inner catheter may be determined based on this measurement.
Regarding claim 7, Gross in view of Gunasekaran teaches the claimed invention and
Gunasekaran further teaches wherein the controller is configured to: determine a first difference between the second impedance and the first impedance; determine a second difference between the third impedance and the first impedance; and determine the location of the inner catheter including a location of the first energy delivery element and a location of the second delivery element based on the first difference and the second difference (fig. 1A-C; paragraph 25-27, 32, and 47). The elongated member 103 be sized to be slidably positioned within a lumen of the neuromodulation catheter 102. Furthermore, the elongated member 103 may comprise other suitable components and/or configurations, which may be a plurality of energy deliver elements 110a-d. Figure 1A shows an energy delivery element 110a disposed on the distal end of the catheter 102. It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.” Therefore a difference between a first and second impedance is disclosed. The location of the inner catheter may be determined based on this measurement.
Regarding claim 20, Gross in view of Gunasekaran teaches the claimed invention and
Gunasekaran further teaches wherein the distal portion of the inner catheter is configured to transform from a delivery configuration to a deployed configuration to change the relative distance between the energy delivery element and the guide catheter energy delivery element (fig. 1A-C; paragraph 25-27, 32, and 47). It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.” Figure 1C shows the distal portion of the inner catheter is in the deployed configuration.
Claims 8-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view
of Gunasekaran in further view of Fuimaono et al. US Pub.: US 20180360342 A1, hereinafter Fuimaono.
Regarding claim 8, Gross in view of Gunasekaran does not teach further comprising: a display
configured to render an image of the renal blood vessel, the guide catheter and the inner catheter including the first energy delivery element and the second energy delivery element within the renal blood vessel; or further comprising: a display configured to render images, wherein the controller is configured to: generate an image of the renal blood vessel, the guide catheter, and the inner catheter within the renal blood vessel, and cause the image to be rendered on the display.
Fuimaono, in the same field of endeavor, teaches further comprising: a display
configured to render an image of the renal blood vessel, the guide catheter and the inner catheter including the first energy delivery element and the second energy delivery element within the renal blood vessel; or further comprising: a display configured to render images, wherein the controller is configured to: generate an image of the renal blood vessel, the guide catheter, and the inner catheter within the renal blood vessel, and cause the image to be rendered on the display (paragraph 48, 54-56, and 63-64).
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 catheter system of Gross in view of Gunasekaran with the display system of Fuimaono for the benefit of providing real-time information of the surgical procedure to the physician.
Regarding claim 9, Gross teaches a therapeutic assembly, comprising:
a guide catheter having a lumen and a guide catheter energy delivery element positioned at a distal portion of the guide catheter, the distal portion being configured to be intravascularly positioned within a renal blood vessel (fig. 5; paragraph 300-303 and 321); Guide catheter 74 is a sheath. A guide catheter energy delivery element 60 may be positioned anywhere along the elongated shaft, including the distal portion of the guide catheter 74.
an inner catheter positioned within the lumen of the guide catheter and having an energy delivery element, the inner catheter being configured to be positioned near a treatment site within the renal blood vessel (fig. 5; paragraph 300-303); The electrode unit 30, elongated shaft 40, and central shaft 48 make up the inner catheter. Electrode unit 30 comprises four pairs 42 of intrarenal electrodes 44.
However, Gross does not teach a display configured to render images; a controller configured to measure an impedance between the first energy delivery element and the guide catheter energy delivery element when the distal portion of the inner catheter is in the deployed configuration; determine a change in a relative distance between the first energy delivery element and the guide catheter energy delivery element based on the impedance and provide a location of the inner catheter within the renal blood vessel based on the change in the relative distance between the first energy delivery element and the guide catheter energy delivery element, and render, on the display, an image of the guide catheter and the inner catheter based on the location of inner catheter within the renal blood vessel.
Fuimaono, in the same field of endeavor, teaches a display configured to render images; and a controller coupled to the guide catheter, the inner catheter and the display and configured to: render, on the display, an image of the guide catheter and the inner catheter based on the location of inner catheter within the renal blood vessel (paragraph 48, 54-56, and 63-64).
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 catheter system of Gross in view of Hettrick with the display system of Fuimaono for the benefit of providing real-time information of the surgical procedure to the physician.
Gunasekaran, in the same field of endeavor, teaches a controller configured to measure an impedance between the first energy delivery element and the guide catheter energy delivery element when the distal portion of the inner catheter is in the deployed configuration (fig. 1A-C; paragraph 25-27, 32, and 47). It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.” Figure 1C shows the distal portion of the inner catheter is in the deployed configuration.
determine a change in a relative distance between the first energy delivery element and the guide catheter energy delivery element based on the impedance and provide a location of the inner catheter within the renal blood vessel based on the change in the relative distance between the first energy delivery element and the guide catheter energy delivery element (fig. 1A-C; paragraph 25-27, 32, and 47). The elongated member 103 be sized to be slidably positioned within a lumen of the neuromodulation catheter 102. Furthermore, the elongated member 103 may comprise other suitable components and/or configurations, which may be a plurality of energy deliver elements 110a-d. Figure 1A shows an energy delivery element 110a disposed on the distal end of the catheter 102. It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the extended catheter of Gross with the elongated member from Gunasekaran for the benefit providing more flexible electrode positioning and to allow the operator to manipulate the distal portion to the desired orientation. Furthermore, it would have been obvious to modify the distal portion of the catheter body from Gross to add an energy delivery element from Gunasekaran for the benefit of determining electrode relative distance between the target site and catheter body for optimal stimulation treatment.
Regarding claim 11, Gross in view of Fuimaono in view of Gunasekaran teaches the claimed
invention and Gunasekaran further teaches wherein the inner catheter is configured to transform from a delivery configuration to a deployed configuration to change the relative distance between the energy delivery element and the guide catheter energy delivery element (fig. 1A-C; paragraph 25-27, 32, and 47). It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.” Figure 1C shows the distal portion of the inner catheter is in the deployed configuration and in a helical spiral.
Regarding claim 12, Gross in view of Fuimaono in view of Gunasekaran teaches the claimed
invention and Gunasekaran further teaches wherein the controller is configured to: measure the first impedance between the energy delivery element and the guide catheter energy delivery element when the inner catheter is in the delivery configuration; measure a second impedance between the first energy delivery element and the guide catheter energy delivery element when the inner catheter is in the deployed configuration; determine a difference between the second impedance and the first impedance; and determine the location of the inner catheter based on the difference (fig. 1A-C; paragraph 25-27, 32, and 47). The elongated member 103 be sized to be slidably positioned within a lumen of the neuromodulation catheter 102. Furthermore, the elongated member 103 may comprise other suitable components and/or configurations, which may be a plurality of energy deliver elements 110a-d. Figure 1A shows an energy delivery element 110a disposed on the distal end of the catheter 102. It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.” Therefore a difference between a first and second impedance is disclosed. The location of the inner catheter may be determined based on this measurement.
Regarding claim 13, Gross in view of Fuimaono in view of Gunasekaran teaches the claimed
invention and Gunasekaran further teaches further comprising: a generator electrically coupled to the guide catheter electrode and the energy delivery element, and configured to deliver neuromodulation energy to the treatment site within the renal blood vessel (paragraph 17-18).
Regarding claim 14, Gross does not teach wherein the controller is configured to: measure a
second impedance between the energy delivery element and the guide catheter energy delivery element; determine a second location of the inner catheter device based on the second impedance; and render, on the display, a second image of a second location of the inner catheter within the renal blood vessel.
Hettrick, in the same field of endeavor, teaches wherein the controller is configured to: measure
a second impedance between the energy delivery element and the guide catheter energy delivery element; determine a second location of the inner catheter device based on the second impedance (fig. 1A-C; paragraph 25-27, 32, and 47). The elongated member 103 be sized to be slidably positioned within a lumen of the neuromodulation catheter 102. Furthermore, the elongated member 103 may comprise other suitable components and/or configurations, which may be a plurality of energy deliver elements 110a-d. Figure 1A shows an energy delivery element 110a disposed on the distal end of the catheter 102. It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the extended catheter of Gross with the elongated member from Gunasekaran for the benefit providing more flexible electrode positioning and to allow the operator to manipulate the distal portion to the desired orientation. Furthermore, it would have been obvious to modify the distal portion of the catheter body from Gross to add an energy delivery element from Gunasekaran for the benefit of determining electrode relative distance between the target site and catheter body for optimal stimulation treatment.
Fuimaono, in the same field of endeavor, teaches and render, on the display, a second image of a second location of the inner catheter within the renal blood vessel (paragraph 48, 54-56, and 63-72).
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 catheter system of Gross in view of Hettrick with the display system of Fuimaono for the benefit of providing real-time information of the location of the catheter during surgical procedure to the physician.
Regarding claim 15, Gross does not teach further comprising: a memory configured to store the
first location and the second location of the inner catheter; wherein the controller is configured to: render, on the display, a third image that includes a plot of the inner catheter from the first location to the second location.
Gunasekaran, in the same field of endeavor, teaches further comprising: a memory configured to the first location and the second location of the inner catheter (paragraph 47-48).
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 system of Gross with the memory storage unit from Gunasekaran for the benefit of storing impedance data to make a graphical analysis of the location of the catheter within the human body.
Fuimaono, in the same field of endeavor, teaches render, on the display, a third image that includes a plot of the inner catheter from the first location to the second location (paragraph 48, 54-56, and 63-72). The XYZ location of the data points are used to create and refine the geometry of the chamber being mapped. Called “point by point” mapping, a cardiologist “builds out the shell” as he acquires more and more points. The catheter is moved along the wall of the anatomical structure to record location points to generate 3D anatomical geometry.
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 catheter system of Gross in view of Hettrick with the display system of Fuimaono for the benefit of providing real-time information of the location of the catheter during surgical procedure to the physician.
Regarding claim 16, Gross a method of renal denervation, comprising:
intravascularly positioning a guide catheter having a lumen and a guide catheter energy delivery element positioned on a distal portion of the guide catheter (fig. 5; paragraph 300-303 and 321); Guide catheter 74 is a sheath.
positioning an inner catheter having a first energy delivery element and a second energy delivery element at or near a treatment site within the renal blood vessel (fig. 5; paragraph 300-303); The electrode unit 30, elongated shaft 40, and central shaft 48 make up the inner catheter. Electrode unit 30 comprises four pairs 42 of intrarenal electrodes 44. A guide catheter energy delivery element 60 may be positioned anywhere along the elongated shaft, including the distal portion of the guide catheter 74.
However, Gross does not teach obtaining, by a processor, an initial image of a renal blood vessel and the guide catheter; measuring, by the processor, an impedance between the first energy delivery element and the guide catheter energy delivery element when the inner catheter is positioned at or near the treatment site: determining, by the processor, a change in a relative distance between the energy delivery element and the guide catheter energy delivery element based on the impedance determining, by the processor, a location of the inner catheter based on the change in the relative distance between the first energy delivery element and the guide catheter energy delivery element; and generating, by the processor, an overlay of an image of the inner catheter on the initial image of the renal blood vessel and the guide catheter based on the location of the inner catheter.
Fuimaono, in the same field of endeavor, teaches obtaining, by a processor, an initial image of a renal blood vessel and the guide catheter; and generating, by the processor, an overlay of an image of the inner catheter on the initial image of the renal blood vessel and the guide catheter based on the location of the inner catheter (paragraph 48, 54-56, and 63-64).
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 catheter system of Gross in view of Hettrick with the display system of Fuimaono for the benefit of providing real-time information of the surgical procedure to the physician.
Gunasekaran, in the same field of endeavor, teaches measuring, by the processor, an impedance between the first energy delivery element and the guide catheter energy delivery element when the inner catheter is positioned at or near the treatment site (fig. 1A-C; paragraph 25-27, 32, and 47). It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.” Figure 1C shows the distal portion of the inner catheter is in the deployed configuration.
determining, by the processor, a change in a relative distance between the energy delivery element and the guide catheter energy delivery element based on the impedance determining, by the processor, a location of the inner catheter based on the change in the relative distance between the first energy delivery element and the guide catheter energy delivery element (fig. 1A-C; paragraph 25-27, 32, and 47). The elongated member 103 be sized to be slidably positioned within a lumen of the neuromodulation catheter 102. Furthermore, the elongated member 103 may comprise other suitable components and/or configurations, which may be a plurality of energy deliver elements 110a-d. Figure 1A shows an energy delivery element 110a disposed on the distal end of the catheter 102. It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the extended catheter of Gross with the elongated member from Gunasekaran for the benefit providing more flexible electrode positioning and to allow the operator to manipulate the distal portion to the desired orientation. Furthermore, it would have been obvious to modify the distal portion of the catheter body from Gross to add an energy delivery element from Gunasekaran for the benefit of determining electrode relative distance between the target site and catheter body for optimal stimulation treatment.
Regarding claim 17, Gross in view of Fuimaono view of Gunasekaran teaches the claimed
invention and Gunasekaran further teaches further comprising: measuring the first impedance between the first energy delivery element and the guide catheter energy delivery element when the inner catheter is in a delivery configuration; measuring a second impedance between the first energy delivery element and the guide catheter energy delivery element when the inner catheter is in a deployed configuration; determining a difference between the second impedance and the first impedance; and determining a location of the inner catheter based on the difference (fig. 1A-C; paragraph 25-27, 32, and 47). The elongated member 103 be sized to be slidably positioned within a lumen of the neuromodulation catheter 102. Furthermore, the elongated member 103 may comprise other suitable components and/or configurations, which may be a plurality of energy deliver elements 110a-d. Figure 1A shows an energy delivery element 110a disposed on the distal end of the catheter 102. It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.” Therefore a second impedance is disclosed. The location of the inner catheter may be determined based on this measurement.
Regarding claim 18, Gross in view of Fuimaono in view of Gunasekaran teaches the claimed
invention and Gunasekaran further teaches further comprising: measuring the first impedance between the first energy delivery element and the guide catheter energy delivery element when the inner catheter is in a delivery configuration; measuring a second impedance between the first energy delivery element and the guide catheter energy delivery element when the inner catheter is in a deployed configuration; and measuring a third impedance between the second energy delivery element and the guide catheter energy delivery element when the inner catheter is in the deployed configuration (fig. 1A-C; paragraph 25-27, 32, and 47). The elongated member 103 be sized to be slidably positioned within a lumen of the neuromodulation catheter 102. Furthermore, the elongated member 103 may comprise other suitable components and/or configurations, which may be a plurality of energy deliver elements 110a-d. Figure 1A shows an energy delivery element 110a disposed on the distal end of the catheter 102. It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.” Therefore a third impedance is disclosed. The location of the inner catheter may be determined based on this measurement.
Regarding claim 19, Gross in view of Fuimaono in view of Gunasekaran teaches the claimed
invention and Gunasekaran further teaches further comprising: determine a first difference between the second impedance and the first impedance; determine a second difference between the third impedance and the first impedance; determine a location of the first energy delivery element based on the first difference; and determine a location of the second energy delivery element based on the second difference (fig. 1A-C; paragraph 25-27, 32, and 47). The elongated member 103 be sized to be slidably positioned within a lumen of the neuromodulation catheter 102. Furthermore, the elongated member 103 may comprise other suitable components and/or configurations, which may be a plurality of energy deliver elements 110a-d. Figure 1A shows an energy delivery element 110a disposed on the distal end of the catheter 102. It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.”.This measurement may be done repeatedly to the electrodes from Gross to determine multiple impedances at different locations. Therefore a second difference is disclosed. The location of the inner catheter may be determined based on this measurement.
Regarding claim 21, Gross in view of Fuimaono in view of Gunasekaran teaches the claimed
invention and Gunasekaran further teaches further comprising, after positioning the inner catheter and before measuring the impedance, transforming the distal portion of the inner catheter from a delivery configuration to a deployed configuration to change the relative distance between the energy delivery element and the guide catheter energy delivery element (fig. 1A-C; paragraph 25-27, 32, and 47). It is disclosed in [47] that “the measurements can include one or more of the following: impedance measurement(s) between two or more of the electrodes 110; a distance between spaced apart portions of the neuromodulation catheter 102; a distance between two or more of the electrodes 110; an angle of rotation of the distal portion of the neuromodulation catheter 102.” Figure 1C shows the distal portion of the inner catheter is in the deployed configuration and in a helical spiral.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/T.J.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792