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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-5, 11-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kunis (US 2013/0204311) in view of Davalos (US 2013/0281968), in further view of Howard (US 2022/0273353).
Regarding claim 1, Kunis teaches a device for ablating tissue adjacent the vein of Marshall in a patient, the device comprising:
an elongated shaft (112) having a proximal portion including a proximal end and an opposite distal portion including a distal end (distal end 114 and proximal end proximal to 114), the distal portion including a preformed curve configured to allow for steering around tortuous anatomy and into the vein of Marshall (par. [0014] with preformed curve as in par. [0214]);
a plurality of ablation electrodes located on the distal portion of the elongated shaft (116), wherein the plurality of ablation electrodes includes a first ablation electrode located at the distal end of the elongated shaft and a second ablation electrode located proximal of the first ablation electrode (116 at a distal end and another 116 more proximal to the distalmost 116);
a connector located at the proximal end of the elongated shaft (connector 162).
Kunis is not explicit regarding a movable insulation sheath surrounding the elongated shaft, the movable insulation sheath being configured for translation over one or more of the plurality of ablation electrodes.However, Davalos teaches an insulating outer sheath over an electrosurgical instrument with an array of ring electrodes, with the outer sheath to be moved to expose or conceal varying parts of the electrode array (par. [0103] and Fig .10, par. [0071] outer sheath to translate over electrodes).It would have been obvious to one of ordinary skill in the art to modify Kunis with the outer sheath of Davalos, as a way of modulating the electrosurgical treatment.Kunis is further silent regarding the connector being configured to removably connect to a control system for delivery of a pulsed field to the plurality of ablation electrodes.However, Howard teaches a generator for pulsed electric field energy delivered to electrodes on a device to ablate tissue (at least par. [0006]), the generator connecting a controller to the device via a connector at the proximal end of the device (Fig. 1, controller 15 connected to 14 to be removably connected device 12).It would have been obvious to one of ordinary skill in the art to modify Kunis with the pulsed field energy of Howard, as a way of providing ablation energy to treat a target tissue.
Regarding claim 2, Kunis teaches further comprising at least one steering wire configured to adjust the shape of the preformed curve (steering wire as in par. [0014]).
Regarding claim 3, Kunis teaches wherein the distal portion includes a diameter in the range of 0.010" to 0.1" (par. [0025]).
Regarding claim 4, Kunis teaches wherein the at least one ablation electrode includes a third ablation electrode located proximal of the second ablation electrode (a third electrode 116 proximal of the most distal 116 electrodes).
Regarding claim 5, Kunis teaches wherein the exposed surface area of the first ablation electrode is in the range of 1.41 mm² to 28.2 mm² (electrode length in par. [0032] and DSC diameter as in par. [0214]).
Regarding claim 11, Kunis teaches further comprising a lumen that extends between the proximal end and the distal end of the elongated shaft (par. [0274] tubular structure from the proximal to distal end).
Regarding claim 12, Kunis teaches wherein the lumen is configured to receive a fluid or to accommodate a guidewire (guidewire lumen as in par. [0274]).
Regarding claim 13, Kunis a method for ablating tissue adjacent the vein of Marshall in a patient, the method comprising:providing an ablation device (112), the ablation device comprising:
an elongated shaft having a proximal portion including a proximal end and an opposite distal portion including a distal end (distal end 114 and proximal end proximal to 114);
at least one ablation electrode located on the distal portion of the elongated shaft (116);
a connector located at the proximal end of the elongated shaft (connector 162),
advancing the ablation device through the vasculature of the patient to position the distal portion of the elongated shaft within the vein of Marshall (par. [0032], [0263]).Kunis is not explicit regarding the connector being configured to removably connect to a control system for delivery of a pulsed field to the at least one ablation electrode, and providing a pulsed field to the at least one ablation electrode to ablate tissue.However, Howard teaches a generator for pulsed electric field energy delivered to electrodes on a device to ablate tissue (at least par. [0006]), the generator connecting a controller to the device via a connector at the proximal end of the device (Fig. 1, controller 15 connected to 14 to be removably connected device 12).It would have been obvious to one of ordinary skill in the art to modify Kunis with the pulsed field energy of Howard, as a way of providing ablation energy to treat a target tissue.Kunis is not explicit regarding a movable insulation sheath surrounding the elongated shaft, the movable insulation sheath being configured for adjustment of an exposed surface area of the at least one ablation electrode; and translating the movable insulation sheath to a desired position.However, Davalos teaches an insulating outer sheath over an electrosurgical instrument with an array of ring electrodes, with the outer sheath to be moved to expose or conceal varying parts of the electrode array (par. [0103] and Fig .10, par. [0071] outer sheath to translate over electrodes).It would have been obvious to one of ordinary skill in the art to modify Kunis with the outer sheath of Davalos, as a way of modulating the electrosurgical treatment.
Regarding claim 14, Kunis teaches wherein the tissue adjacent the vein of Marshall includes myocardial sleeves and adjacent myocardium (par. [0240]).
Regarding claim 15, Kunis teaches wherein the tissue adjacent the vein of Marshall includes a source of ventricular arrhythmias (par. [0260]-[0261]).
Regarding claim 16, Kunis teaches wherein the at least one ablation electrode includes first ablation electrode located at the distal end and a second ablation electrode located proximal of the first ablation electrode (116 at a distal end and another 116 more proximal to the distalmost 116).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kunis in view of Davalos, in further view of Howard, in further view of Afonso (US 2013/0274582).
Regarding claim 6, Kunis is not explicit regarding the device further comprising a magnetic sensor located in the distal portion.However, Afonso teaches magnetic field sensors at a distal end of the device to determine location information of the distal end of the device (par. [0061]).It would have been obvious to one of ordinary skill in the art to modify Kunis with the magnetic sensors of Afonso, to detect the location of the device to allow for treatment at the target location.
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kunis in view of Davalos, in further view of Howard, in further view of Cosman (US 9,008,793).
Regarding claim 7, Kunis is silent regarding at least one sensing electrode located on the distal portion.However, Cosman teaches electrodes that can be set to an EMG measuring electrode (col. 7, line 66 to col. 8 line 9).
It would have been obvious to one of ordinary skill in the art to modify Kunis with the EMG measuring electrode of Cosman to measure progression of a treatment.
Regarding claim 8, Kunis is silent wherein the at least one sensing electrode is an EMG electrode.However, Cosman teaches electrodes that can be set to an EMG measuring electrode (col. 7, line 66 to col. 8 line 9).
It would have been obvious to one of ordinary skill in the art to modify Kunis with the EMG measuring electrode of Cosman to measure progression of a treatment.
Regarding claim 9, Kunis teaches wherein the at least one sensing electrode or the plurality of ablation electrodes comprises a plurality of evenly spaced electrodes (par. [0014]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kunis in view of Davalos, in further view of Howard, in further view of Cosman, in further view of Deno (US 2016/0331471).
Regarding claim 10, Kunis is not explicit wherein the at least one sensing electrode or the plurality of ablation electrodes comprises a plurality of unevenly spaced electrodes.However, Deno teaches electrodes of a catheter device can be evenly or unevenly spaced (par. [0051]).It would have been obvious to one of ordinary skill in the art to modify the electrode spacing of Kunis to be unevenly spaced depending on the desired treatment pattern.
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kunis in view of Howard, in further view of Afonso.
Regarding claim 17, Kunis teaches a method for ablating tissue adjacent the vein of Marshall in a patient, the method comprising:
providing an ablation device (112), the ablation device comprising:
an elongated shaft having a proximal portion including a proximal end and an opposite distal portion including a distal end (distal end 114 and proximal end proximal to 114);
a plurality of ablation electrodes located on the distal portion of the elongated shaft (electrodes 116), wherein the plurality of ablation electrodes includes a first ablation electrode located at the distal end of the elongated shaft and a second ablation electrode located proximal of the first ablation electrode (116 at a distal end and another 116 more proximal to the distalmost 116);
a connector located at the proximal end of the elongated shaft (162); and
advancing the ablation device through the vasculature of the patient to position the distal portion of the elongated shaft within the vein of Marshall (par. [0032], [0263]).
Kunis is silent regarding the connector being configured to removably connect to a control system for delivery of a pulsed field to the plurality of ablation electrodes, and providing a pulsed field to the plurality of ablation electrodes to ablate tissue adjacent the vein of Marshal.However, Howard teaches a generator for pulsed electric field energy delivered to electrodes on a device to ablate tissue (at least par. [0006]), the generator connecting a controller to the device via a connector at the proximal end of the device (Fig. 1, controller 15 connected to 14 to be removably connected device 12).It would have been obvious to one of ordinary skill in the art to modify Kunis with the pulsed field energy of Howard, as a way of providing ablation energy to treat a target tissue.Kunis is further silent regarding one or more sensor; and advancing using positional data from the one or more sensor.However, Afonso teaches magnetic field sensors at a distal end of the device to determine location information of the distal end of the device (par. [0061]).It would have been obvious to one of ordinary skill in the art to modify Kunis with the magnetic sensors of Afonso, to detect the location of the device to allow for advancing the device to the target location for treatment.
Regarding claim 18, Kunis teaches wherein the tissue adjacent the vein of Marshall includes myocardial sleeves and adjacent myocardium (par. [0240]).
Regarding claim 19, Kunis teaches wherein the tissue adjacent the vein of Marshall includes a source of ventricular arrhythmias (par. [0260]-[0261]).
Regarding claim 20, Kunis teaches wherein the at least one ablation electrode includes first ablation electrode located at the distal end and a second ablation electrode located proximal of the first ablation electrode (116 at a distal end and another 116 more proximal to the distalmost 116).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Longoria (US 2010/0185186) teaches the vein of Marshall as a source of arrythmia and a target to be ablated.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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