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 Objections
Claims 11 and 12 are objected to because of the following informalities: claims 11 and 12 recite "any one of claims 8," when there is only one claim 8. Appropriate correction is required.
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) 1-4, 6-9, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bar-Tal (US 2018/0344202), in view of Levinson (US 2012/0022518), in further view of Sutermeister (US 2019/0159833).
Regarding claim 1, Bar-Tal a medical probe comprising:
a shaft extending along a longitudinal axis (probe 22 with shaft as in Fig. 1);
a plurality of spines extending from a distal end of the shaft and configured to expand away from the longitudinal axis to form a resilient basket (spines 64 expanding away from the longitudinal axis from distal end 26 of probe); and
a plurality of electrodes (par. [0061]), each electrode of the plurality of electrodes comprising:
a respective electrically conductive body circumscribing a respective spine of the plurality of spines (conductor 66).Bar-Tal is not explicit regarding an impedance reducing coating on an outer surface of the respective electrically conductive body such that the outer surface faces away from the longitudinal axis, and an impedance increasing coating on an inner surface of the respective electrically conductive body such that the inner surface faces toward the longitudinal axis.However, Levinson teaches an impedance increasing coating on an inner surface of an electrically conductive body (par. [0082]).It would have been obvious to one of ordinary skill in the art to modify Bar-Tal with the impedance increasing coating of Levinson to prevent unwanted damage to tissue.Sutermeister teaches conductive polymer coatings used on electrodes as in par. [0026].It would have been obvious to one of ordinary skill in the art to modify Bar-Tal with the conductive polymer coating of Sutermeister as a way of applying a coating, to increase the effective surface area without heating (abst.).
Regarding claim 2, Bar-Tal teaches wherein each electrode of the plurality of electrodes is configured to sense tissue contact and provide ablation energy (par. [0061]).
Regarding claim 3, Bar-Tal is not explicit wherein the impedance reducing coating comprises a conductive polymer.However, Sutermeister teaches conductive polymer coatings used on electrodes as in par. [0026].It would have been obvious to one of ordinary skill in the art to modify Bar-Tal with the conductive polymer coating of Sutermeister as a way of applying a coating, to increase the effective surface area without heating (abst.).
Regarding claim 4, Bar-Tal is not explicit wherein the impedance increasing coating comprises a ceramic.However, Levinson teaches a silicon nitride coating to insulate a material (par. [0082]).It would have been obvious to one of ordinary skill in the art that the impedance increasing coating comprises silicon nitride, as in Levinson, as a known insulating coating material for electrosurgical devices.
Regarding claim 6, wherein the impedance increasing coating comprises Si₃N₄.However, Levinson teaches a silicon nitride coating to insulate a material (par. [0082]).It would have been obvious to one of ordinary skill in the art that the impedance increasing coating comprises silicon nitride, as in Levinson, as a known insulating coating material for electrosurgical devices.
Regarding claim 7, Bar-Tal teaches wherein each electrode of the plurality of electrodes is configured for electrocardiogram sensing (par. [0061] electrodes for recording ECG signals).
Regarding claim 8, Bar-Tal teaches a method, comprising:
providing a medical probe comprising a shaft extending along a longitudinal axis (probe 22 with shaft as in Fig. 1), a plurality of spines extending from a distal end of the shaft and configured to expand away from the longitudinal axis to form a resilient basket (spines 64 expanding away from the longitudinal axis from distal end 26 of probe to form a basket), and a plurality of electrodes each comprising a respective electrically conductive body circumscribing a respective spine of the plurality of spines (par. [0061] conductor 66).Bar-Tal is silent regarding applying an impedance reducing coating to an outer surface of a respectively conductive body of each electrode of the plurality of electrodes such that the outer surface faces away from the longitudinal axis; and applying an impedance increasing coating on an inner surface of the respective electrically conductive body such that the inner surface faces toward the longitudinal axis.However, Levinson teaches an impedance increasing coating on an inner surface of an electrically conductive body (par. [0082]).It would have been obvious to one of ordinary skill in the art to modify Bar-Tal with the impedance increasing coating of Levinson to prevent unwanted damage to tissue.Sutermeister teaches conductive polymer coatings used on electrodes as in par. [0026].It would have been obvious to one of ordinary skill in the art to modify Bar-Tal with the conductive polymer coating of Sutermeister as a way of applying a coating, to increase the effective surface area without heating (abst.).
Regarding claim 9, Bar-Tal is not explicit wherein applying the impedance reducing coating comprises electrodepositing the impedance reducing coating.However, Sutermeister teaches applying the impedance reducing coating comprises electrodepositing the impedance reducing coating (par. [0008] electrochemical deposition).It would have been obvious to one of ordinary skill in the art to modify Bar-Tal with the conductive polymer coating of Sutermeister as a way of applying a coating, to increase the effective surface area without heating (abst.).
Regarding claim 11, Bar-Tal is not explicit wherein the impedance reducing coating comprises a conductive polymer.However, Sutermeister teaches conductive polymer coatings used on electrodes as in par. [0026].It would have been obvious to one of ordinary skill in the art to modify Bar-Tal with the conductive polymer coating of Sutermeister as a way of applying a coating, to increase the effective surface area without heating (abst.).
Regarding claim 12, Bar-Tal is not explicit wherein the impedance increasing coating comprises a ceramic.However, Levinson teaches a silicon nitride coating to insulate a material (par. [0082]).It would have been obvious to one of ordinary skill in the art that the impedance increasing coating comprises silicon nitride, as in Levinson, as a known insulating coating material for electrosurgical devices.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bar-Tal, in view of Levinson, in further view of Sutermeister, in further view of Davies (US 2016/0066989).
Regarding claim 5, Bar-Tal is not explicit wherein the impedance increasing coating comprises a thermal conductivity of approximately 7 W/mK to approximately 30 W/mK. Levinson teaches silicon nitride coating as above.Davies teaches a thermal conductivity of silicon nitride ranging from 15-40 W/mK (par. [0014]). It would have been obvious to one of ordinary skill in the art that the silicon nitride coating would have a thermal conductivity within the 7-30 W/mK range, as taught by Davies, allowing for a thermal shield to prevent unwanted thermal damage to tissue (par. [0014]).
Claim(s) 10, 13-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bar-Tal, in view of Levinson, in further view of Sutermeister, in further view of Willard (US 2014/0025069).
Regarding claim 10, Bar-Tal is silent regarding wherein applying the impedance increasing coating comprises aerosol depositing the impedance increasing coating.However, Willard teaches spray coating as a well known coating technique for insulating coating on an electrosurgical basket (par. [0074]).It would have been obvious to one of ordinary skill in the art to apply the impedance increasing coating via spray coating as in Willard, as a known method of applying the coating to an electrosurgical device.
Regarding claim 13, Bar-Tal a system comprising:
a medical probe comprising a shaft (probe 22 with shaft as in Fig. 1), one or more spines extending from a distal end of the shaft (spines 64 expanding away from the longitudinal axis from distal end 26 of probe), and a plurality of electrodes each comprising a respective electrically conductive body circumscribing a respective spine of the one or more spines (par. [0061] conductors 66),a console comprising at least one processor and non-transitory computer-readable medium in communication with the at least one processor and comprising instructions thereon (processor 46 with computer-readable medium as in par. [0049]).Bar-Tal is not explicit each of the plurality of electrodes comprising an impedance reducing coating on a first surface of the respective electrically conductive body and an impedance increasing coating on a second surface of the respective electrically conductive body.However, Levinson teaches an impedance increasing coating on an inner surface of an electrically conductive body (par. [0082]).It would have been obvious to one of ordinary skill in the art to modify Bar-Tal with the impedance increasing coating of Levinson to prevent unwanted damage to tissue.Sutermeister teaches conductive polymer coatings used on electrodes as in par. [0026].It would have been obvious to one of ordinary skill in the art to modify Bar-Tal with the conductive polymer coating of Sutermeister as a way of applying a coating, to increase the effective surface area without heating (abst.).
Bar-Tal is further silent regarding the instructions, when executed by the processor, cause the console to:
sense, based in part on an impedance measurement between one or more electrode pairs of the plurality of electrodes, contact of at least a portion of the plurality of electrodes with tissue, and provide electrical energy to at least a portion of the plurality of electrodes to ablate tissue.However, Willard teaches sensing impedance between electrodes and adjusting treatment based on measured impedance (par. [0034]).It would have been obvious to one of ordinary skill in the art to modify Bar-Tal with the impedance measurement of Willard, as a way to monitor and modify treatment to properly ablate tissue.
Regarding claim 14, Bar-Tal is not explicit wherein the impedance measurement between the one or more electrode pairs is based at least in part on an impedance of the impedance reducing coating and an impedance of the impedance increasing coating of each electrode of the one or more electrode pairs.However, Willard teaches sensing impedance between electrodes and adjusting treatment based on measured impedance (par. [0034]).
It would have been obvious to one of ordinary skill in the art to modify Bar-Tal with the impedance measurement of Willard, as a way to monitor and modify treatment to properly ablate tissue. One of ordinary skill in the art would appreciate that coatings that alter impedance would alter the measured impedance of the electrodes.
Regarding claim 15, Bar-Tal is not explicit wherein the non-transitory computer-readable medium comprises instructions thereon, that when executed by the processor, cause the console to:
sense, based in part on the impedance measurement between the one or more electrode pairs and assuming that the impedance increasing coating of each electrode of the one or more electrode pairs is in contact with blood, contact of at least a portion of the plurality of electrodes with tissue.However, Willard teaches sensing impedance between electrodes and adjusting treatment based on measured impedance, and contact with tissue (par. [0034], [0066] sensor contacting vessel wall).
It would have been obvious to one of ordinary skill in the art to modify Bar-Tal with the impedance measurement of Willard, as a way to monitor and modify treatment to properly ablate tissue.
Regarding claim 16, Bar-Tal teaches wherein the electrical energy comprises radiofrequency ablation energy (electrodes for RF ablation as in par. [0061]).
Regarding claim 17, Bar-Tal is not explicit wherein the impedance reducing coating comprises a conductive polymer.However, Sutermeister teaches conductive polymer coatings used on electrodes as in par. [0026].It would have been obvious to one of ordinary skill in the art to modify Bar-Tal with the conductive polymer coating of Sutermeister as a way of applying a coating, to increase the effective surface area without heating (abst.).
Regarding claim 18, Bar-Tal is not explicit wherein the impedance increasing coating comprises a ceramic.However, Levinson teaches a silicon nitride coating to insulate a material (par. [0082]).It would have been obvious to one of ordinary skill in the art that the impedance increasing coating comprises silicon nitride, as in Levinson, as a known insulating coating material for electrosurgical devices.It would have been obvious to one of ordinary skill in the art that the impedance increasing coating comprises silicon nitride, as in Levinson, as a known insulating coating material for electrosurgical devices.
Regarding claim 20, wherein the impedance increasing coating comprises Si₃N₄.
However, Levinson teaches a silicon nitride coating to insulate a material (par. [0082]).It would have been obvious to one of ordinary skill in the art that the impedance increasing coating comprises silicon nitride, as in Levinson, as a known insulating coating material for electrosurgical devices.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bar-Tal, in view of Levinson, in further view of Sutermeister, in further view of Willard, in further view of Davies.
Regarding claim 19, Bar-Tal is not explicit wherein the impedance increasing coating comprises a thermal conductivity of approximately 30 W/mK.Davies teaches a thermal conductivity of silicon nitride ranging from 15-40 W/mK (par. [0014]). It would have been obvious to one of ordinary skill in the art that the silicon nitride coating would have a thermal conductivity within the 7-30 W/mK range, as taught by Davies, allowing for a thermal shield to prevent unwanted thermal damage to tissue (par. [0014]).
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
Prosecution Insights