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 .
Response to Amendment
The Amendments filed June 25, 2026 have been entered. Applicant’s amendments have overcome the abstract objection previously set-forth in the Non-Final Office Action mailed on 03/31/2026. Currently, claims 1 and 10 have been amended, claims 6-8, 15-17 have been cancelled, and claims 1-5, 9-14, and 18 are pending in the application.
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 1-4, 9-13, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (U.S. Application No. 20190110704 A1), in view of Sinenikov (U.S. Application No. 20150257779 A1).
Regarding independent claims 1 and 10, Wang discloses a preoperative and a postoperative detection method for neuromapping (pa. 0158, 0303), performed by using an electrode catheter system (pa. 0160, 0168 & Figs. 1-2), the electrode catheter system comprises an interventional catheter (101) (specifically in the embodiment where the catheter is made up of two separate entities, one delivering the energy for nerve stimulation, and the other nerve ablation as seen Fig. 24, pa. 0161) provided with an electrode element (2411) that can release an electrical signal toward an inner wall of a renal artery blood vessel on one lateral side of a body of a patient (pa. 0298); a pressure sensor (103) for intervening to the renal artery blood vessel (pa. 0160); and a data processing module (103) (different from the pressure sensor since the catheter system comprises one or more sensors to receive inputs of physiological signals, pa. 0159) connected with the pressure sensor (pa. 0160), wherein the pressure sensor is arranged in another renal artery blood vessel on the other lateral side of the body of the patient (pa. 0163). Examiner highlights the embodiment where the pressure sensor is placed in the lumen of the renal artery or any other artery; i.e., including a renal artery blood vessel on the other lateral side of the body of the patient; wherein the method comprises:
releasing an electrical signal (due to a dose of energy from a power source 102) towards the renal artery blood vessel on one lateral side of the body of the patient by the electrode element (pa. 0160);
monitoring a heart rate by an electrocardiogram monitoring module (pa. 0074), and monitoring a blood pressure change in said another renal artery blood vessel on the other lateral side of the body of the patient by the pressure sensor (pa. 0074), and determining a nerve activity degree of the patient by judging whether the heart rate and the blood pressure change reach certain thresholds/a baseline physiological response (pa. 0187, 0190). Specifically, the catheter system is configured to locate/identify and map the physiological responses, such as the changes in blood pressure and heart rate, wherein the amount of change in the physiological response indicates the presence/absence of an underlying sympathetic nerve distribution in the vicinity of the activated electrode element. The steps comprise applying an electrical stimulation by introducing electrical current to a first site via the electrode elements, measuring said one or more physiological parameters after the electrical stimulation, wherein an increase of the physiological parameters as compared to measurements obtained before the electrical stimulation (i.e., a baseline) indicate the presence of a renal nerve/the nerve activity degree is strong, and wherein no increase of the physiological parameters after the electrical stimulation indicates an absence of the renal nerve/the nerve activity degree is insufficient (pa. 0208, 0210). If there is a presence of a renal nerve/the nerve activity degree is strong, then an ablation procedure is conducted. After the ablation procedure, electrical stimulation is delivered to the ablated spot to confirm if the procedure was successful (i.e., no changes in the physiological parameters is observed/the nerve activity degree has been reduced to a standard value) (pa. 0059), or not successful (i.e., an increase in the physiological parameters/the nerve activity degree still remains strong) (pa. 0209-0210);
wherein the interventional catheter is further provided with an ablation element (2421) (pa. 0298), and the ablation element is located at a distal end of the interventional catheter and the electrode element is located at a proximal end of the ablation element (pa. 0217). Examiner highlights in the embodiment described in paragraph 0217, since both sets of electrodes are configured to deliver one or both of electrical stimulation and ablation energy, then this meets the claim of the ablation element being located at a distal end of the interventional catheter and the electrode element being located at a proximal end of the ablation element.
Wang further discloses wherein the ablation element is fixed to the distal end of the interventional catheter (pa. 0217), and the energy delivered is one or more of electrical, mechanical, ultrasonic, radiation, optical and thermal energies (pa. 0062).
However, Wang does not explicitly disclose the ablation element comprising a balloon and an ultrasonic transducer disposed in the balloon, nor wherein a water inlet cavity and a water outlet cavity arranged in the interventional catheter, and both the water inlet cavity and the water outlet cavity are in communication with the balloon, respectively.
Sinenikov, in the same field of endeavor, teaches systems and methods for treating patients having sympathetically mediated disease associated with a heightened sympathetic activation by ablating a nerve associated therewith (pa. 0004). In one embodiment, ablation can be performed using an ultrasound ablation catheter (313) comprising ultrasonic emitter (230) (pa. 0128) and a balloon (145) in order to separate the transducer/ultrasonic emitter from the vessel wall (147) while providing a conduit for an energy beam and cooling of the transducer (pa. 0141 & Figs. 4A-4B). The balloon (145) is filled with a circulating fluid (148), such as sterile water or saline, and the fluid is recirculated by an external pump (not shown) through the catheter shaft (pa. 0141). The coolant is delivered via fluid delivery lumen/water inlet cavity (542) and is returned via coolant return slot/water outlet cavity (532) arranged in the interventional catheter (see Figs. 12C-12D), and both in communication with the balloon (pa. 0159).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the balloon and the ultrasonic transducer of Sinenikov into the ultrasonic ablating device of Wang in order to separate the transducer/ultrasonic emitter from the vessel wall while providing a conduit for an energy beam and cooling of the transducer (Sinenikov, pa. 0141).
Furthermore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have added the inlet and outlet cavities taught by Sinenikov in order to allow for the cooling of the transducer.
Regarding claims 2 and 11, Wang discloses the electrode element (i.e., combination of resilient member 2300 and electrodes 2301) (pa. 0150 & Figs. 23A-23C), is made of an elastic metal material (the resilient members of this invention comprises super elastic materials such as memory shape alloys) (pa. 0297), and has a first state and a second state, wherein
when the electrode element is received in the intervention catheter (2304), the electrode element is in the first state (pa. 0150 & Figs. 23A);
when the electrode element is fitted with the inner wall of the renal artery blood vessel, the electrode element is in the second state (pa. 0152 & Fig. 23C).
Regarding claims 3 and 12, Wang discloses wherein the electrode catheter system comprises a control filament (2305) and a first filament guide cavity that receives the control filament (lumen of the intervention catheter), the first filament guide cavity is arranged in the interventional catheter, and the electrode element is connected with the control filament, and the control filament slides in the first filament guide cavity by an external force (pa. 0152, 296).
Regarding claims 4 and 13, Wang discloses wherein the electrode element is preformed to have an arc shape (see Fig. 23C), and both ends of the electrode element are fixedly connected to the control filament (pa. 0296).
Regarding claims 9 and 18, Wang discloses wherein a proximal end of the interventional catheter is provided with a handle, wherein the handle controls the push/pull of a controlling wire/rod connected to the electrode element (pa. 0151-0152, 0291).
However, Wang does not explicitly disclose wherein the handle is provided with a control button to control the electrode element.
Sinenikov, in the same field of endeavor, teaches a handle at the proximal end of the catheter, wherein the handle may include a button in order to control tension of a pull wire that controls the movements of the distal portion of the catheter (pa. 0185).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have added the button of Sinenikov to the handle of Wang for the purpose of providing the user with an easy method for controlling the movement of the electrode element.
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Wang and Sinenikov as applied to claims 1 and 10 above, in view of a different embodiment taught by the Wang reference.
Regarding claims 5 and 14, Wang discloses a different embodiment where the electrode element is preformed to have a spiral ring shape (pa. 0291), and one end of the electrode element is fixedly connected with the control filament (see Figs. 21F-21H).
It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have modified the shape of the electrodes elements to have a spiral shape, since applicant has not disclosed that the shape of the electrode element solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with either shape.
Response to Arguments
Applicant's arguments filed 06/25/2026 have been fully considered but they are not persuasive.
With regards to newly amended independent claims 1 and 10, Applicant argues that the Sinenikov reference does not teach the newly amended language of previously cancelled claim 8 of a water inlet cavity and a water outlet cavity arranged in the interventional catheter, and both the water inlet cavity and the water outlet cavity are in communication with the balloon, respectively. Specifically, Applicant contends that Sinenikov only teaches a single cavity design that results in fluid contamination instead of separate water inlet cavity and water outlet cavity. However, Examiner, respectfully, disagrees.
The Sinenikov reference teaches ablation performed using an ultrasound ablation catheter (313) comprising ultrasonic emitter (230) (pa. 0128) and a balloon (145) (pa. 0141 & Figs. 4A-4B). The balloon (145) is filled with a circulating fluid (148), such as sterile water or saline, and the fluid is recirculated by an external pump (not shown) through the catheter shaft (pa. 0141). The coolant is delivered via fluid delivery lumen/water inlet cavity (542) and is returned via coolant return slot/water outlet cavity (532) arranged in the interventional catheter (see Figs. 12C-12D), and both in communication with the balloon (pa. 0159). As seen in Figures 12C-12E, it is clear that the inlet and outlet cavities are two separate lumens and therefore cannot result in fluid contamination. Figure 12E shows a cross-section of the catheter shaft, wherein a first PTFE liner (523) defines a lumen (542) dedicated to contain the delivery of coolant. Coolant fluid is pumped through tubing by a peristaltic pump to a coolant inlet port on a proximal region of the ablation catheter that is in fluid communication with the first liner or the water inlet cavity (pa. 0158). Figure 12C shows a second lumen liner (524), separate from the first lumen, that is in communication with the water outlet cavity of the manifold component. Coolant in the chamber exits through the water outlet cavity and passes through lumen (543) of the second lumen liner to be removed from the catheter at its proximal region (pa. 0159). Therefore, based on the reasonings set-forth above, the rejection using the Wang and Sinenikov references are maintained.
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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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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