DETAILED ACTION
This action is responsive to the application filed 2/15/22.
Claims 1-14 are rejected.
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 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.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, it is not clear what is meant by the limitation of “wherein the shape of the intermediate section is different than a shape of the proximal section and a shape of a distal section.”
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-11 and 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Haverkost (US 20120029510) in view of Zarins et al. (US 20080255642, “Zarins”) and Walker et al. (US 20040176699, “Walker”).
Regarding claim 1, Haverkost teaches an apparatus for intravascular thermal neuromodulation (Abstract, “A catheter includes a flexible shaft having a distal end dimensioned for deployment within a patient's renal artery.”), comprising: a control unit (Fig. 16, RF generator 320); a catheter in communication with the processor (Fig. 16, catheter 100 in communication with electrode activation circuitry 320), wherein the catheter comprises: an elongate body configured to be inserted into a blood vessel (Fig. 16, elongated catheter 100 is inserted into renal artery 12), wherein the elongate body includes a proximal portion and a distal portion (Par. 3, ‘A catheter comprises a flexible shaft having a proximal end, a distal end, and a length, the length of the shaft sufficient to access the target vessel relative to the percutaneous access location.’), and wherein the distal portion includes a distal tip (Fig. 16, distal tip of flexible shaft 104); and an expandable structure (Par. 75, ‘The resilient members 131 of a wire segment arrangement 127 can be arranged to form expandable curves or loops. ’) comprising a plurality of support arms (Fig. 12, resilient members 131), wherein each of the plurality of support arms comprises a proximal section (Fig. 12, proximalmost portions of resilient members 131 where 131 interfaces with shaft 104) , an intermediate section (Fig. 12, intermediate portion of resilient members 131 which contain electrodes 120), and a distal section (Fig. 12, distalmost portion of resilient members 131 which interfaces with shaft 104); and an actuator (Par. 90, ‘ According to some embodiments, a control wire 133 is attached to the distal end of the resilient member 131 and actuatable by a clinician at the proximal end of the catheter 100, such as in the manner described previously with regard to FIGS. 5 and 6. In other embodiments, a control wire 133 is not used, and the retraction and expansion mechanism discussed above operates automatically in response to application and removal of compressive force to and from the resilient member 131 during use.’) configured to deploy the expandable structure through a plurality of expansion states with different arrangements of the expandable structure, the elongate body, and the distal tip (Abstract, ‘The elongated resilient members are collapsible when encompassed within a lumen of an outer sheath and extensible radially outward from the shaft at the regions defined between the longitudinally spaced-apart engagement locations when the catheter and the resilient members are axially extended beyond the distal tip of the sheath.’), wherein the intermediate section of a support arm of the plurality of support arms comprises a plurality of electrodes longitudinally spaced from one another along the intermediate section (Fig. 12, each resilient member 131 contains a plurality of electrodes 120 along its central portion) and configured to deliver energy to a wall of the blood vessel (Abstract, ‘RF energy is delivered to the electrodes for ablating perivascular renal nerves.’), wherein the plurality of expansion states comprises: a first expansion state (Abstract, the first expansion state can be mapped to the collapsed configuration); and a second expansion state (Abstract, the second expansion state can be mapped to the expanded configuration); and all of the plurality of electrodes simultaneously contact the wall (Par. 24, ‘Deployment of the wire segments places the RF electrodes in good contact with the vessel wall.’), and wherein, with the expandable structure deployed in the second expansion state, the processor is configured to selectively control the plurality of electrodes to deliver the energy to: a length of the wall spanning the entire intermediate section via all of the plurality of electrodes, wherein opposite ends of the length are longitudinally spaced from one another; or a spot of the wall spanning only a portion of the intermediate section via only a subset of the plurality of electrodes (Par. 74, ‘In such embodiments, all or at least some of the electrodes 120 supported by individual resilient members 131 are individually controllable, allowing for selective activation and deactivation of electrodes 120 of the basket or mesh arrangements 127.’).
Haverkost fails to teach that the control unit comprises a processor; that in the first expansion state the distal portion and the distal tip are in contact with each other and the expandable structure is disposed within the distal portion; and that in the second expansions state the distal portion and the distal tip are spaced apart from each other.
Regarding the control unit aspect, Zarins teaches an analogous apparatus for intravascular thermal neuromodulation (Abstract, ‘Methods and system are provided for thermally-induced renal neuromodulation.’), comprising: a control unit comprising is a processor (Fig. 3A, processor 114); and a catheter (Fig. 3A, probe 104; par. 54, ‘The probe 104 can be […] an intravascular catheter’) in communication with the processor (Par. 53, ‘The processor 114 is in communication with the field generator 110 to control the power output of the field generator 110 for providing the desired amount of energy to the target neural structures’).
Therefore, in view of Zarins, it would have been obvious to POSITA to modify Haverkost by providing the control unit with a processor in order to configure the control unit to be programmable, as taught by Zarins.
Regarding the expansion states aspect, Walker teaches an analogous intravascular device (Abstract, “A flexible thermography catheter which includes an elongated body having a proximal end, a distal end, and a distal section, an expandable body ”) comprising: a catheter comprising an elongate body configured to be inserted into a blood vessel (Figs. 5-6 and 11, Elongate Body 14 having a sleeve 36), wherein the elongate body includes a proximal portion (Figs. 1-3, proximal portion adjacent to the elongated body receiver 22) and a distal portion (Figs. 1-2, distal section 18), and wherein the distal portion includes a distal tip (Figs. 4 and 12, distal tip 44); and an expandable structure (Fig. 2, expandable body 16) comprising a plurality of support arms (Fig. 12, support arms 50), wherein each of the plurality of support arms comprises a proximal section and a distal section (Fig. 12, the proximal section can be considered a section proximal to the distal end of the of the support arm and the distal section can be considered a section distal to the proximal end of the support arm); and an actuator configured to deploy the expandable structure through a plurality of expansion states with different arrangements of the expandable structure, the elongate body, and the distal tip (Fig. 2 and par. 67, ‘The outer sleeve 36 may be in communication with or attached to the elongated body actuator 28 positioned within the actuator recess 30 located on the handle body 20 of the handle 12 (see. FIG. 3). The rearward movement of the elongated body actuator 28 within the actuator recess 30 results in the outer sleeve 36 retracting rearwardly from the distal tip 44 (see FIG. 4), thereby permitting the expandable body 16 to expand radially.’), wherein the plurality of expansion states comprises: a first expansion state in which the distal portion and the distal tip are in contact with each other and the expandable structure is disposed within the distal portion ( Figs. 4 and 6, distal tip 44 is in contact with distal portion of 14 in a first unexpanded state; par. 64); and a second expansion state in which the distal portion and the distal tip are spaced apart from each other, and the plurality of support arms are radially expanded outwards (Fig. 12, distal tip 44 is spaced apart from distal portion of 14 when the body is in an expanded condition).
Therefore, in view of Walker, it would have been obvious to POSITA at the time that the invention was filed to further modify Haverkost, as modified, by implementing the basket deployment configuration disclosed by Walker in which the basket is provided in an unexpanded configuration within the body of the catheter while the catheter is being advanced through the vascular system to the target location and deployed in an expanded configuration outside of the catheter body at the treatment location, in order to facilitate introduction of the catheter to the treatment location, as taught by Walker.
Regarding claim 2, Haverkost, as modified, teaches wherein the intermediate section comprises a shape configured for contact with the wall (Par. 24, ‘Deployment of the wire segments places the RF electrodes in good contact with the vessel wall.’), but fails to teach wherein the shape of the intermediate section is different than a shape of the proximal section and a shape of the distal section.
Zarins, however, further teaches an expandable structure (Fig. 5c, expandable basket 304) comprising a plurality of support arms (Fig. 5c, struts of expandable basket 304), wherein each of the plurality of support arms comprises a proximal section (Fig. 5c, struts 304 have proximal sections which extend from catheter 302 to the wall of the renal artery), and intermediate section (Fig. 5c, struts 304 have intermediate sections which extend along and parallel to the renal artery), and a distal section (Fig. 5c, struts 304 have distal sections which extend from the wall of the renal artery back to catheter 302), wherein the intermediate section comprises a shape configured for contact with the wall (Fig. 5c, showing the intermediate sections of struts 304 in contact with the wall of the renal artery), wherein the shape of the intermediate section is different than a shape of the proximal section and a shape of the distal section (Fig. 5c, the shapes of the intermediate sections can be considered ‘different’ since they have different slopes relative to the proximal and distal sections).
Therefore, since both Haverkost and Zarins teach different expandable basket configurations for use in catheter systems which target renal nerves via the renal artery, it would have been obvious to POSITA to substitute one known expandable basket configuration for the other in order to arrive at the predictable result of an expandable basket configuration for targeting renal nerves via the renal artery. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 3, Haverkost, as modified, further teaches wherein the shape comprises a flattened shape (Haverkost has previously been modified in view of Zarins to utilize the expandable basket configuration of Zarins; see Zarins, fig. 5c, showing a flat intermediate section which contains electrodes 306c).
Regarding claim 4, Haverkost, as modified, further teaches wherein the spot of the wall is located between the opposite ends of the length (Par. 74, which teaches that the system is configured to selectively activate electrodes in contact with the wall which are inherently located between opposite ends of the intermediate section contacting the wall).
Regarding claim 5, Haverkost, as modified, further teaches wherein the support arm of the plurality of support arms comprises a plurality of sensors different than the plurality of electrodes (Par. 32, ‘One or more temperature sensors, such as thermocouples, can be provided at the site of the electrodes to measure the temperature of the electrodes. In some embodiments, a temperature sensor is positioned near or at the site of each electrode, allowing for precision temperature measurements at individual electrode locations of the ablation electrode arrangement.’).
Regarding claim 6, Haverkost, as modified, further teaches wherein the plurality of sensors are longitudinally spaced from one another along the intermediate section (Par. 32, ‘One or more temperature sensors, such as thermocouples, can be provided at the site of the electrodes to measure the temperature of the electrodes. In some embodiments, a temperature sensor is positioned near or at the site of each electrode, allowing for precision temperature measurements at individual electrode locations of the ablation electrode arrangement.’).
Regarding claim 7, Haverkost, as modified, further teaches wherein the plurality of sensors are interleaved with the plurality of electrodes along the intermediate section (Par. 32, ‘One or more temperature sensors, such as thermocouples, can be provided at the site of the electrodes to measure the temperature of the electrodes. In some embodiments, a temperature sensor is positioned near or at the site of each electrode, allowing for precision temperature measurements at individual electrode locations of the ablation electrode arrangement.’; for instance, the embodiment in which the temperature sensors are placed near the electrodes they can be considered to be ‘interleaved’ with the electrodes) such that the plurality of electrodes are longitudinally spaced from one another along the intermediate section by the plurality of sensors (Fig. 12, showing electrodes 120 spaced apart from each other along resilient members 131).
Regarding claim 8, Haverkost, as modified, further teaches wherein the plurality of sensors comprises at least one of an ultrasonic sensor, a flow sensor, a thermal sensor, a blood temperature sensor, an electrical contact sensor, a conductivity sensor, an impedance sensor, an electromagnetic detector, a pressure sensor, a chemical or hormonal sensor, a pH sensor, an infrared sensor, or a contact pressure sensor configured to detect a pressure applied by an electrode of the plurality of electrodes at the wall (Par. 32, ‘One or more temperature sensors, such as thermocouples, can be provided at the site of the electrodes to measure the temperature of the electrodes.’).
Regarding claim 9, Haverkost, as modified, further teaches wherein the plurality of sensors is configured to: obtain sensor data representative of the blood vessel (Par. 99, ‘In some embodiments, temperature sensors are situated at the treatment element 101 and provide for continuous monitoring of renal artery tissue temperatures’); and transmit the sensor data to the processor (Par. 93, ‘The external electrode activation circuitry 320, which includes an RF generator, is coupled to temperature measuring circuitry 328 […]’; further, the control unit has previously been modified in view of Zarins to comprise a processor; see Zarins, fig. 3a, processor 114).
Regarding claim 10, Haverkost, as modified, further teaches wherein the processor (The control unit has previously been modified in view of Zarins to comprise a processor; see Zarins, fig. 3a, processor 114) is further configured to selectively control the plurality of electrodes to deliver the energy based on the sensor data (Par. 99, ‘RF generator power is automatically adjusted so that the target temperatures are achieved and maintained.’).
Regarding claim 11, Haverkost, as modified, fails to teach wherein the elongate body further comprises an intravascular ultrasound (IVUS) imaging apparatus configured to obtain images of the wall.
Walker, however, further teaches the use of an IVUS imaging apparatus to facilitate precise positioning of the catheter within the blood vessel (Par. 92, ‘The thermography catheter 10 may include IVUS or other imaging devices thereon, thereby permitting the user to precisely position the thermography catheter 10 within the blood vessel.’).
Therefore, in view of Walker, it would have been obvious to POSITA to further modify Haverkost, as modified, with an IVUS imaging device in order to facilitate precise positioning of the catheter within the blood vessel, as taught by Walker.
Regarding claim 14, Haverkost, as modified, further teaches wherein the plurality of electrodes is configured to deliver the energy through the wall to a renal nerve (Par. 2, ‘Various embodiments of the disclosure are directed to apparatuses and methods for ablating perivascular renal nerves, such as for treatment of hypertension.’).
Claim 12 is rejected under pre-AIA 35 U.S.C. 103 (a) as being unpatentable over Haverkost in view of Zarins and Walker, as applied to claims 1-11 and 14, above, and further view of Cespedes (US 20090024040).
Regarding claim 12, Haverkost, as modified, fails to teach wherein the IVUS imaging apparatus is positioned within the expandable structure.
Cespedes, however, teaches an analogous IVUS device which is located within an analogous expandable member of an intravascular catheter system (Fig. 2 and par. 49, ‘FIG. 2 shows an embodiment similar to that shown in FIG. 1 but further including a radially viewing IVUS element 220 centrally disposed on central shaft within the basket section of the catheter.’).
Therefore, since both Haverkost, as modified, and Cespedes teach different locations configurations for an IVUS element in relation to an expandable element of an intravascular catheter, it would have been obvious to POSITA to substitute one known IVUS location configuration for the other in order to arrive at the predictable result of a location configuration for an IVUS element in the context on intravascular catheter. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim 13 is rejected under pre-AIA 35 U.S.C. 103 (a) as being unpatentable over Haverkost in view of Zarins and Walker, as applied to claims 1-11 and 14, above, and further view of Steinke (US 20050096647).
Regarding claim 13, Haverkost, as modified, fails to teach wherein the processor is configured to register the plurality of electrodes at a circumferential position of the expandable structure with a corresponding circumferential location of the blood vessel based on an intravascular image.
Steinke teaches an analogous device for delivering radiofrequency energy to intravascular tissue which comprises: a processor (Fig. 2a, processor 49); a catheter in communication with the processor (Fig. 2a, catheter 12), wherein the catheter comprises: an elongate body including a proximal portion and a distal portion (Fig. 2a, catheter 12 has proximal end 16 and distal end 18), the distal portion including a distal tip (Fig. 2, distal tip 30), the elongate body configured to have an unexpanded condition (Fig. 10a) and an expanded condition (Fig. 10b); an expandable structure configured to have an expanded condition and an unexpanded condition (Fig. 10b, expandable structure 26), the expandable structure including a plurality of support arms (Fig. 9, struts 54); a plurality of electrodes positioned on the plurality of support arms at different circumferential positions of the expandable structure (Fig. 9, electrodes 50), wherein the plurality of electrodes is configured to deliver energy to a target tissue (Abstract, ‘An atherosclerotic material detector near the distal end of the catheter body may measure circumferential atherosclerotic material distribution, and a power source selectively energizes the electrodes to eccentrically remodel the measured atherosclerotic material’); and wherein the processor is configured to register the plurality of electrodes at a circumferential position of the expandable structure with a corresponding circumferential location of the blood vessel based on an intravascular image. (Par. 107, ‘In controller 92a, a simple dial 96 is turned to point to a desired electrode pair to be energized. A "key" electrode may be registered with the intravascular imaging system, either electronically or by providing an electrode, electrode support member, or attached marker which presents a distinct image on the intravascular imaging display. This simplifies selection of one or more eccentric electrode pair along atheroma.’).
Therefore, in view of Steinke, it would have been obvious to POSITA at the time that the invention was made to further modify Haverkost, as modified, by configuring the processor to register the different electrodes using an imaging system, as taught by Steinke, in order to simplify the selection of electrode sets for treating the desired tissue locations, as taught by Steinke.
Conclusion
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ADAM JOSEPH. AVIGAN
Examiner
Art Unit 3739
/ADAM J AVIGAN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794