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 amendment filed December 18th, 2025 has been entered. Claims 1, 10, 11, & 19 are amended. Claims 1-20 remain pending.
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument; as necessitate by amendment.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Richardson et al. (previously presented-US 20130123778 A1), hereinafter “Richardson”, in view of Hettrick et al. (previously presented-US 20190151013 A1), hereinafter “Hettrick”, and Wang (US 20220087740 A1), hereinafter “Wang”.
Regarding method claim 1, Richardson discloses a method of lesion assessment for a medical ablation procedure, the method comprising: acquiring first impedance measurements between each of a plurality of ablation electrodes of a medical probe and a stem electrode of the medical probe ([0066]-[0068], [0070]; Figures 5 & 6—element 412 & 414; impedance is calculated between the ablation electrodes 412 and sensing electrode 414; the examiner is considering the stem electrode to be the sensing electrode 414); acquiring second impedance measurements between each of the ablation electrodes of the medical probe and an edge electrode of the medical probe ([0066]-[0068], [0070]; Figures 5 & 6—element 412 & 420; impedance is calculated between the ablation electrodes 412 and the ground pad 420; the examiner is considering the edge electrode to be the ground pad electrode 420), the stem electrode being distal on the medical probe ([0064], [0067]; Figure 6—element 414); ablating tissue of patient anatomy ([0066] & [0070]); determining, during ablation of the tissue, impedance magnitude changes by comparing at least one of the first impedance measurements or the second impedance measurements to subsequent corresponding impedance measurements acquired during the ablation ([0026], [0036], [0068], [0070] & [0071]; the impedance measurements may include complex impedance measurements; the impedance is monitored prior to and during ablation; as target tissue is ablated the change in impedance may be analyzed to determine how much tissue has been ablated; as the complex impedance may be measured and change in the complex impedance is analyzed to determine how much tissue is ablated, it is the examiners position that the changes in the complex impedance would include changes in the impedance magnitude); and indicating lesion formation based on determining the impedance magnitude changes ([0026], [0036], [0070] & [0071]; the impedance is monitored prior to and during ablation; as target tissue is ablated the change in impedance may be analyzed to determine how much tissue has been ablated).
Richardson does not disclose the edge electrode being disposed on the medical probe; prior to ablating tissue of patient anatomy, determining a level of contact sufficiency between at least one of the plurality of ablation electrodes and the tissue based on the first impedance measurements and the second impedance measurements; ablating tissue in response to determining that the level of contact sufficiency is sufficient; and the indicating lesion formation based on determining that the impedance magnitude changes exceed a threshold value indicative of lesion formation in the tissue.
Hettrick discloses a comprising: acquiring first impedance measurements between each of a plurality of ablation electrodes of a medical probe and a stem electrode of the medical probe and acquiring second impedance measurements between each of the ablation electrodes of the medical probe and an edge electrode of the medical probe ([0026], & [0030]-[0034]; Figure 5—elements 124 & 200; Figure 6—element 604; the controller is configured to monitor the impedance between each of the ablation electrodes 124 and each of the reference electrodes 200; the examiner is considering the stem electrode to be a first reference electrode 200 and the edge electrode to be a second reference electrode 200); the stem electrode being disposed on the medical probe and the edge electrode being disposed on the medical probe ([0021] & [0031]; the reference electrodes 200 may be patch electrodes to be positioned on the patient’s body, the “reference electrodes 200 may also be carried on the catheter 102, guide catheter, guide wire, introducer, and/or a separate reference electrode catheter configured to be positioned at a desired location within the patient's vasculature”).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the edge electrode, as disclosed by Richardson, to include the edge electrode being disposed on the medical probe, as taught by Hettrick, as both references and the claimed invention are directed toward methods of ablation and measuring impedance between a plurality of ablation electrodes and a plurality of reference electrodes. As disclosed by Richardson, the edge electrode may be a ground pad electrode, impedance can be measured between the ablation electrodes and the ground pad/edge electrode ([0069]). As disclosed by Hettrick, impedance may be measured between the ablation electrodes and the reference electrodes, the reference electrodes may be in the form of ground pad electrodes or alternatively may be carried on the medical probe ([0026], & [0030]-[0034]). 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 edge electrode, as disclosed by Richardson, to include the edge electrode being disposed on the medical probe, as taught by Hettrick, as providing an edge/reference electrode on the medical probe is a known and suitable alternative to providing an edge electrode in the form of a ground pad electrode, and such a modification would produce the predictable result of providing a suitable reference electrode for use in impedance measurements during an ablation procedure.
Wang teaches a method of lesion assessment for a medical ablation procedure comprising prior to ablating tissue of patient anatomy, determining a level of contact sufficiency between at least one of the plurality of ablation electrodes and the tissue based on the first impedance measurements and the second impedance measurements; ablating the tissue of patient anatomy with the at least one of the plurality of ablation electrodes in response to determining that the level of contact sufficiency is sufficient ([0046] & [0046]; each electrode detects a contact impedance value, if the electrodes are determined to be in good contact, based on the impedance value, radio frequency energy will be delivered to ablate the lesion tissue); and indicating lesion formation based on determining that the impedance magnitude changes exceed a threshold value indicative of lesion formation in the tissue ([0053]-[0054]; determining the effectiveness of the ablation comprises determining a change of impedance exceeds a certain amount).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of ablating tissue and indicating lesion formation based on impedance magnitude changes, as disclosed by Richardson, to include prior to ablating tissue of patient anatomy determining a level of contact sufficiency between at least one of the plurality of ablation electrodes and the tissue based on the first impedance measurements and the second impedance measurements, and indicating the lesion formation based on determining that the impedance magnitude changes exceed a threshold value, as taught by Wang, as both references and the claimed invention are directed toward methods of assessing and indicating lesion formation using impedance measurements. As disclosed by Richardson, the complex impedance and changes in impedance may be monitored before and during ablation, such that the changes in impedance can be analyzed to indicate how much tissue has been ablated ([0026], [0068], & [0071]). As disclosed by Wang, prior to ablation, the impedance measurements may be taken to detect contact between the electrodes and tissue, such that when the electrodes are indicated to be in good contact with tissue the radiofrequency energy is delivered to ablate the tissue, after the radio frequency is output impedance values are observed and recorded and the effectiveness of the ablation can be determined according to the change of impedance exceeding a predetermined value, these features provide for a safer and more effective method of delivering energy ([0008], [0053], [0054], [0096], & [0114]). 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 method of ablating tissue and indicating lesion formation based on impedance magnitude changes, as disclosed by Richardson, to include prior to ablating tissue of patient anatomy determining a level of contact sufficiency between at least one of the plurality of ablation electrodes and the tissue based on the first impedance measurements and the second impedance measurements, and indicating the lesion formation based on determining that the impedance magnitude changes exceed a threshold value, as taught by Wang, as such a modification would determine if the electrodes are in sufficient contact with the target tissue to begin ablation and would produce the predictable result of analyzing impedance measurements to determine lesion formation and the effectiveness of ablation, both of which features provide for a safer and more effective method of delivering energy.
Regarding method claim 2, Richardson in view of Hettrick and Wang disclose all of the limitations of claim 1, as described above.
Richardson does not disclose the indicating of the lesion formation being based on the determined impedance magnitude changes exceeding the threshold value indicative of lesion formation in the tissue comprising displaying the impedance magnitude changes.
Wang further teaches the indicating of the lesion formation being based on the determined impedance magnitude changes exceeding the threshold value indicative of lesion formation in the tissue comprising displaying the impedance magnitude changes ([0010]-[0012], [0061], & [0114]-[0117]; Figure 19).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of indicating lesion formation based on impedance magnitude changes exceeding the threshold value, as disclosed by Richardson in view of Wang, to further include displaying the impedance changes, as further taught by Wang, as both references and the claimed invention are directed toward methods of assessing and indicating lesion formation using impedance measurements. As disclosed by Wang, output impedance values are observed, recorded, and displayed such that the effectiveness of the ablation can be determined according to the change of impedance exceeding a predetermined value, these features provide for a safer and more effective method of delivering energy ([0010]-[0012], [0061], & [0114]-[0117]). 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 method of indicating lesion formation based on impedance magnitude changes exceeding the threshold value, as disclosed by Richardson in view of Wang, to further include displaying the impedance changes, as further taught by Wang, as such a modification would provide the user with feedback regarding the ablation procedure and ablation effectiveness.
Regarding method claim 3, Richardson in view of Hettrick and Wang disclose all of the limitations of claim 1, as described above.
Richardson further discloses the medical probe comprising a balloon catheter ([0065]; Figures 5 & 6—element 406 & 408; the expandable frame 408 may be an expandable balloon).
Regarding method claim 4, Richardson in view of Hettrick and Wang disclose all of the limitations of claim 1, as described above.
Richardson further discloses the first impedance measurements and the second impedance measurements being acquired prior to ablating the tissue of patient anatomy ([0071]; impedance may be determined prior to ablation).
Regarding method claim 5, Richardson in view of Hettrick and Wang disclose all of the limitations of claim 1, as described above.
Richardson further discloses the determining the impedance magnitude changes comprising continuously monitoring the impedance magnitude changes during ablation of the tissue ([0035], [0067], [0070], & [0071]; tissue impedance may be monitored during ablation, multiple impedance measurements may be taken to analyze change in impedance and provide real-time feedback).
Regarding method claim 6, Richardson in view of Hettrick and Wang disclose all of the limitations of claim 1, as described above.
Richardson further discloses the first impedance measurements being first unipolar impedance measurements, the second impedance measurements being second unipolar impedance measurements, the subsequent corresponding impedance measurements being subsequent corresponding unipolar impedance measurements, the impedance magnitude changes being changes to unipolar impedance values ([0068], [0070], & [0076]; Figure 6; tissue impedance may be monitored during simultaneous unipolar ablation methods; during ablation, changes to the impedance calculated between the ablation electrodes 412 and edge electrode 420 and between ablation electrodes 412 and stem electrode 414 are analyzed).
Regarding method claim 7, Richardson in view of Hettrick and Wang disclose all of the limitations of claim 6, as described above.
Richardson further discloses comparing, for each ablation electrode, a change between one of the first unipolar impedance measurements and a subsequent corresponding unipolar impedance measurement; and indicating the lesion formation ([0070], [0071], & [0076]; tissue impedance may be monitored during simultaneous unipolar ablation methods; multiple impedance measurements are taken between ablation electrodes 412 and edge/ground pad electrode 420 and between ablation electrodes 412 and stem electrode 414, the changes in impedance values are analyzed to determine/indicate how much tissue has been ablated).
Richardson does not disclose comparing the change to a unipolar impedance threshold value, the unipolar impedance threshold value being a reduction in impedance of about 15 to about 20 ohms, which reduction is the threshold value indicative of lesion formation in the tissue; and indicating the lesion formation when the change between one of the first unipolar impedance measurements and the subsequent corresponding unipolar impedance measurement is equal to or greater than the unipolar impedance threshold value.
Wang further teaches comparing the change to a unipolar impedance threshold value, the unipolar impedance threshold value being a reduction in impedance of about 15 to about 20 ohms, which reduction is the threshold value indicative of lesion formation in the tissue; and indicating the lesion formation when the change between one of the first unipolar impedance measurements and the subsequent corresponding unipolar impedance measurement is equal to or greater than the unipolar impedance threshold value ([0010]-[0012]; the effectiveness of ablation is determined based on the change of impedance, such as a fall in impedance, the ablation is determined to be effective when a fall in impedance exceeds 10 to 100 ohms).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of indicating lesion formation based on unipolar impedance changes, as disclosed by Richardson, to include indicating the lesion formation based on determining that the impedance changes are equal to or greater than a threshold value, as further taught by Wang, as both references and the claimed invention are directed toward methods of assessing and indicating lesion formation using impedance measurements. As disclosed by Richardson, the complex impedance and changes in impedance may be monitored before and during ablation, such that the changes in impedance can be analyzed to indicate how much tissue has been ablated ([0026], [0068], & [0071]). As disclosed by Wang, the effectiveness of the ablation can be determined based on a fall in impedance, such that the ablation is determined to be effective when a fall in impedance exceeds 10 to 100 ohms, this feature provides a safer and more effective method of delivering energy ([0008], & [0010]-[0011]). 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 method of indicating lesion formation based on unipolar impedance changes, as disclosed by Richardson, to include indicating the lesion formation based on determining that the impedance changes are equal to or greater than a threshold value, as further taught by Wang, as such a modification would produce the predictable result of analyzing impedance measurements to determine lesion formation, while also providing an indication of the effectiveness of the ablation that leads to a safer and more effective method of delivering energy.
Regarding method claim 8, Richardson in view of Hettrick and Wang disclose all of the limitations of claim 1, as described above.
Richardson further discloses the first impedance measurements being first relative bipolar impedance measurements, the second impedance measurements being second relative bipolar impedance measurements, the subsequent corresponding impedance measurements being subsequent corresponding relative bipolar impedance measurements, the impedance magnitude changes being changes to relative bipolar impedance values ([0070] & [0076]; Figure 6; tissue impedance may be monitored during simultaneous bipolar ablation methods; during ablation, changes to the impedance calculated between the ablation electrodes 412 and edge electrode 420 and between ablation electrodes 412 and stem electrode 414 are analyzed).
Regarding method claim 9, Richardson in view of Hettrick and Wang disclose all of the limitations of claim 8, as described above.
Richardson further discloses comparing, for each ablation electrode, a change between one of the first relative bipolar impedance measurements and a subsequent corresponding relative bipolar impedance measurement; and indicating the lesion formation ([0070], [0071], & [0076]; tissue impedance may be monitored during simultaneous bipolar ablation methods; multiple impedance measurements are taken between ablation electrodes 412 and edge/ground pad electrode 420 and between ablation electrodes 412 and stem electrode 414, the changes in impedance values are analyzed to determine/indicate how much tissue has been ablated).
Richardson does not disclose comparing the change to a relative bipolar impedance threshold value, the relative bipolar impedance threshold value being a predetermined magnitude of a reduction in relative bipolar impedance, which reduction is the threshold value-indicative of lesion formation in the tissue; and indicating the lesion formation when the magnitude of the change between the is equal to or greater than the relative bipolar impedance threshold value.
Wang further teaches comparing the change to a relative bipolar impedance threshold value, the relative bipolar impedance threshold value being a predetermined magnitude of a reduction in relative bipolar impedance, which reduction is the threshold value-indicative of lesion formation in the tissue; and indicating the lesion formation when the magnitude of the change between the is equal to or greater than the relative bipolar impedance threshold value ([0010]-[0012]; the effectiveness of ablation is determined based on the change of impedance, such as a fall in impedance, the ablation is determined to be effective when a fall in impedance exceeds 10 to 100 ohms).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of indicating lesion formation based on relative bipolar impedance changes, as disclosed by Richardson, to include indicating the lesion formation based on determining that the impedance changes are equal to or greater than a threshold value, as further taught by Wang, as both references and the claimed invention are directed toward methods of assessing and indicating lesion formation using impedance measurements. As disclosed by Richardson, the complex impedance and changes in impedance may be monitored before and during ablation, such that the changes in impedance can be analyzed to indicate how much tissue has been ablated ([0026], [0068], & [0071]). As disclosed by Wang, the effectiveness of the ablation can be determined based on a fall in impedance, such that the ablation is determined to be effective when a fall in impedance exceeds 10 to 100 ohms, this feature provides a safer and more effective method of delivering energy ([0008], & [0010]-[0011]). 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 method of indicating lesion formation based on relative bipolar impedance changes, as disclosed by Richardson, to include indicating the lesion formation based on determining that the impedance changes are equal to or greater than a threshold value, as further taught by Wang, as such a modification would produce the predictable result of analyzing impedance measurements to determine lesion formation, while also providing an indication of the effectiveness of the ablation that leads to a safer and more effective method of delivering energy.
Regarding claim 10, Richardson discloses a processing device for use during a medical procedure ([0068]; Figure 1—element 18), the processing device comprising: a processor configured to: acquire first impedance measurements between each of a plurality of ablation electrodes of a medical probe and an edge electrode of the medical probe ([0066]-[0068], [0070]; Figures 5 & 6—element 412 & 420; impedance is calculated between the ablation electrodes 412 and the ground pad 420; the examiner is considering the edge electrode to be the ground pad electrode 420); acquire second impedance measurements between each of the ablation electrodes and a stem electrode of the medical probe ([0066]-[0068], [0070]; Figures 5 & 6—element 412 & 414; impedance is calculated between the ablation electrodes 412 and sensing electrode 414; the examiner is considering the stem electrode to be the sensing electrode 414), the stem electrode being disposed on the medical probe ([0064], [0067]; Figure 6—element 414); initiate the ablation of the tissue with the at least one of the plurality of ablation ([0066] & [0070]); determine, during ablation of tissue of patient anatomy, impedance magnitude changes by comparing at least one of the first impedance measurements and the second impedance measurements to subsequent corresponding impedance measurements acquired during the ablation ([0026], [0036], [0068], [0070] & [0071]; the impedance measurements may include complex impedance measurements; the impedance is monitored prior to and during ablation; as target tissue is ablated the change in impedance may be analyzed to determine how much tissue has been ablated; as the complex impedance may be measured and change in the complex impedance is analyzed to determine how much tissue is ablated, it is the examiners position that the changes in the complex impedance would include changes in the impedance magnitude); and indicate lesion formation ([0026], [0036], [0070] & [0071]; as target tissue is ablated the change in impedance may be analyzed to determine how much tissue has been ablated).
Richardson does not disclose the processing device comprising: memory configured to store data; the edge electrode being disposed on the medical probe; prior to an ablation of tissue of patient anatomy, determine a level of contact sufficiency between at least one of the plurality of ablation electrodes and the tissue based on the first impedance measurements and the second impedance measurements; initiate the ablation of the tissue in response to a determination that the level of contact sufficiency is sufficient; and the indicate lesion formation based on the determination that the impedance magnitude changes exceed a threshold value indicative of lesion formation in the tissue.
Hettrick discloses a processing device configured to acquire first impedance measurements between each of a plurality of ablation electrodes of a medical probe and an edge electrode of the medical probe and acquire second impedance measurements between each of the ablation electrodes of the medical probe and a stem electrode of the medical probe ([0026], & [0030]-[0034]; Figure 5—elements 124 & 200; Figure 6—element 604; the controller is configured to monitor the impedance between each of the ablation electrodes 124 and each of the reference electrodes 200; the examiner is considering the edge electrode to be a first reference electrode 200 and the stem electrode to be a second reference electrode 200); the stem electrode being disposed on the medical probe; the processing device comprising: memory configured to store data ([0024], [0032], & [0087]; Figure 1—element 104; the impedance measurements may be stored in the console 104 for further use by the operator); the edge electrode being disposed on the medical probe ([0021] & [0031]; the reference electrodes 200 may be patch electrodes to be positioned on the patient’s body, the “reference electrodes 200 may also be carried on the catheter 102, guide catheter, guide wire, introducer, and/or a separate reference electrode catheter configured to be positioned at a desired location within the patient's vasculature”).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the processing device and edge electrode, as disclosed by Richardson, to include the processing device comprising a memory configured to store data and the edge electrode being disposed on the medical probe, as taught by Hettrick, as both references and the claimed invention are directed toward ablation systems configured to measuring impedance between a plurality of ablation electrodes and a plurality of reference electrodes. As disclosed by Richardson, the edge electrode may be a ground pad electrode, impedance can be measured between the ablation electrodes and the ground pad/edge electrode ([0069]). As disclosed by Hettrick, impedance may be measured between the ablation electrodes and the reference electrodes, the reference electrodes may be in the form of ground pad electrodes or alternatively may be carried on the medical probe; the processing device may be configured to receive and store impedance measurements for further use by the clinician ([0024], [0026], & [0030]-[0034]). 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 processing device and edge electrode, as disclosed by Richardson, to include the processing device comprising a memory configured to store data and the edge electrode being disposed on the medical probe, as taught by Hettrick, as such a modification would allow for the processing device to store impedance measurements for further use by a clinician, and providing an edge/reference electrode on the medical probe is a known and suitable alternative to providing an edge electrode in the form of a ground pad electrode and such a modification would produce the predictable result of providing a suitable reference electrode for use in impedance measurements during an ablation procedure.
Wang teaches a processing device for an ablation procedure configured to prior to an ablation of tissue of patient anatomy, determine a level of contact sufficiency between at least one of the plurality of ablation electrodes and the tissue based on the first impedance measurements and the second impedance measurements; initiate the ablation of the tissue in response to a determination that the level of contact sufficiency is sufficient ([0046] & [0046]; each electrode detects a contact impedance value, if the electrodes are determined to be in good contact, based on the impedance value, radio frequency energy will be delivered to ablate the lesion tissue); and the indicate lesion formation based on the determination that the impedance magnitude changes exceed a threshold value indicative of lesion formation in the tissue ([0053]-[0054]; determining the effectiveness of the ablation comprises determining a change of impedance exceeds a certain amount).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the device for ablating tissue and the indication lesion formation based on impedance magnitude changes, as disclosed by Richardson, to include the device configured to prior to an ablation of tissue of patient anatomy, determine a level of contact sufficiency between at least one of the plurality of ablation electrodes and the tissue based on the first impedance measurements and the second impedance measurements, and the indicate lesion formation based on the determination that the impedance magnitude changes exceed a threshold value indicative of lesion formation in the tissue, as taught by Wang, as both references and the claimed invention are directed toward ablation devices for assessing and indicating lesion formation using impedance measurements. As disclosed by Richardson, the complex impedance and changes in impedance may be monitored before and during ablation, such that the changes in impedance can be analyzed to indicate how much tissue has been ablated ([0026], [0068], & [0071]). As disclosed by Wang, prior to ablation, the impedance measurements may be taken to detect contact between the electrodes and tissue, such that when the electrodes are indicated to be in good contact with tissue the radiofrequency energy is delivered to ablate the tissue, after the radio frequency is output impedance values are observed and recorded and the effectiveness of the ablation can be determined according to the change of impedance exceeding a predetermined value, these features provide for a safer and more effective device for delivering energy ([0008], [0053], [0054], [0096], & [0114]). 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 device for ablating tissue and the indication lesion formation based on impedance magnitude changes, as disclosed by Richardson, to include the device configured to prior to an ablation of tissue of patient anatomy, determine a level of contact sufficiency between at least one of the plurality of ablation electrodes and the tissue based on the first impedance measurements and the second impedance measurements, and the indicate lesion formation based on the determination that the impedance magnitude changes exceed a threshold value indicative of lesion formation in the tissue, as taught by Wang, as such a modification would determine if the electrodes are in sufficient contact with the target tissue to begin ablation and would produce the predictable result of analyzing impedance measurements to determine lesion formation and the effectiveness of ablation, both of which features provide for a safer and more effective device for delivering energy.
Regarding claim 11, Richardson in view of Hettrick and Wang disclose all of the limitations of claim 10, as described above.
Richardson does not disclose the processor being configured to indicate the lesion formation based on the determined impedance magnitude changes exceeding the threshold value indicative of lesion formation in the tissue by displaying the impedance magnitude changes on a display device.
Wang further teaches the processor being configured to indicate the lesion formation based on the determined impedance magnitude changes exceeding the threshold value indicative of lesion formation in the tissue by displaying the impedance magnitude changes on a display device ([0010]-[0012], [0061], & [0114]-[0117]; Figure 19).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the indication of lesion formation based on impedance magnitude changes exceeding the threshold value, as disclosed by Richardson in view of Wang, to further include the processor being configured to indicate the lesion formation based on the determined impedance magnitude changes exceeding the threshold value indicative of lesion formation in the tissue by displaying the impedance magnitude changes on a display device, as further taught by Wang, as both references and the claimed invention are directed toward ablation devices for assessing and indicating lesion formation using impedance measurements. As disclosed by Wang, output impedance values are observed, recorded, and displayed such that the effectiveness of the ablation can be determined according to the change of impedance exceeding a predetermined value, these features provide for a safer and more effective device of delivering energy ([0010]-[0012], [0061], & [0114]-[0117]). 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 indication of lesion formation based on impedance magnitude changes exceeding the threshold value, as disclosed by Richardson in view of Wang, to further include the processor being configured to indicate the lesion formation based on the determined impedance magnitude changes exceeding the threshold value indicative of lesion formation in the tissue by displaying the impedance magnitude changes on a display device, as further taught by Wang, as such a modification would provide the user with feedback regarding the ablation procedure and ablation effectiveness.
Regarding claim 12, Richardson in view of Hettrick and Wang disclose all of the limitations of claim 10, as described above.
Richardson further discloses the medical probe being a balloon catheter ([0065]; Figures 5 & 6—element 406 & 408; the expandable frame 408 may be an expandable balloon).
Regarding claim 13, Richardson in view of Hettrick and Wang disclose all of the limitations of claim 10, as described above.
Richardson further discloses the processor being configured to: acquire the first impedance measurements and the second impedance measurements prior to ablating the tissue of patient anatomy ([0071]; impedance may be determined prior to ablation).
Richardson does not disclose the processor configured to store the first impedance measurements and the second impedance measurements as impedance data in the memory.
Hettrick further teaches a processing system for determining changes in impedance measurements ([0026], & [0030]-[0034]), the processor configured to acquire impedance measurements prior to ablating tissue ([0032]), and store the impedance measurements as impedance data in the memory ([0024] & [0032]; the impedance measurements may be stored in the console for further user by the clinician).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the processing system as disclosed by Richardson, to include the processor configured to store the impedance measurements as impedance data in the memory, as further taught by Hettrick, as both references and the claimed invention are directed toward ablation systems configured to measure impedance. As disclosed by Hettrick, the controller and console may save receive and store impedance measurements for further use by the clinician ([0024] & [0032]). 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 processing system as disclosed by Richardson, to include the processor configured to store the impedance measurements as impedance data in the memory, as further taught by Hettrick, as such a modification would allow for the processing device to receive and store recorded impedance measurements for further use by the clinician.
Regarding claim 14, Richardson in view of Hettrick and Wang disclose all of the limitations of claim 10, as described above.
Richardson further discloses the processor being configured to determine the impedance magnitude changes by continuously monitoring the impedance magnitude changes during the ablation of the tissue ([0035], [0067], [0070], & [0071]; tissue impedance may be monitored during ablation, multiple impedance measurements may be taken to analyze change in impedance and provide real-time feedback).
Regarding claim 15, Richardson in view of Hettrick and Wang disclose all of the limitations of claim 10, as described above.
Richardson further discloses the first impedance measurements being first unipolar impedance measurements, the second impedance measurements being second unipolar impedance measurements, the subsequent corresponding impedance measurements being subsequent corresponding unipolar impedance measurements, the impedance magnitude changes being changes to unipolar impedance values ([0068], [0070], & [0076]; Figure 6; tissue impedance may be monitored during simultaneous unipolar ablation methods; during ablation, changes to the impedance calculated between the ablation electrodes 412 and edge electrode 420 and between ablation electrodes 412 and stem electrode 414 are analyzed).
Regarding claim 16, Richardson in view of Hettrick and Wang disclose all of the limitations of claim 15, as described above.
Richardson further discloses the processor being configured to: compare, for each ablation electrode, a change between one of the first unipolar impedance measurements and a subsequent corresponding unipolar impedance measurement; and indicate the lesion formation ([0070], [0071], & [0076]; tissue impedance may be monitored during simultaneous unipolar ablation methods; multiple impedance measurements are taken between ablation electrodes 412 and edge/ground pad electrode 420 and between ablation electrodes 412 and stem electrode 414, the changes in impedance values are analyzed to determine/indicate how much tissue has been ablated).
Richardson does not disclose the processor being configured to: compare the change to a unipolar impedance threshold value, the unipolar impedance threshold value being a reduction in impedance of about 15 to about 20 ohms, which reduction is the threshold value indicative of lesion formation in the tissue; and indicate the lesion formation when the change between the one of the first unipolar impedance measurements and the subsequent corresponding unipolar impedance measurement is equal to or greater than the unipolar impedance threshold value.
Wang further teaches the processor being configured to: compare the change to a unipolar impedance threshold value, the unipolar impedance threshold value being a reduction in impedance of about 15 to about 20 ohms, which reduction is the threshold value indicative of lesion formation in the tissue; and indicate the lesion formation when the change between the one of the first unipolar impedance measurements and the subsequent corresponding unipolar impedance measurement is equal to or greater than the unipolar impedance threshold value ([0010]-[0012]; the effectiveness of ablation is determined based on the change of impedance, such as a fall in impedance, the ablation is determined to be effective when a fall in impedance exceeds 10 to 100 ohms).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the indication of lesion formation based on unipolar impedance changes, as disclosed by Richardson, to include the indication of lesion formation based on determining that the impedance changes are equal to or greater than a threshold value, as further taught by Wang, as both references and the claimed invention are directed toward ablation devices for assessing and indicating lesion formation using impedance measurements. As disclosed by Richardson, the complex impedance and changes in impedance may be monitored before and during ablation, such that the changes in impedance can be analyzed to indicate how much tissue has been ablated ([0026], [0068], & [0071]). As disclosed by Wang, the effectiveness of the ablation can be determined based on a fall in impedance, such that the ablation is determined to be effective when a fall in impedance exceeds 10 to 100 ohms, this feature provides a safer and more effective device for delivering energy ([0008], & [0010]-[0011]). 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 indication of lesion formation based on unipolar impedance changes, as disclosed by Richardson, to include the indication of lesion formation based on determining that the impedance changes are equal to or greater than a threshold value, as further taught by Wang, as such a modification would produce the predictable result of analyzing impedance measurements to determine lesion formation, while also providing an indication of the effectiveness of the ablation that leads to a safer and more effective device for delivering energy.
Regarding claim 17, Richardson in view of Hettrick and Wang disclose all of the limitations of claim 10, as described above.
Richardson further discloses the first impedance measurements being first relative bipolar impedance measurements, the second impedance measurements being second relative bipolar impedance measurements, the subsequent corresponding impedance measurements being subsequent corresponding relative bipolar impedance measurements, the impedance magnitude changes being changes to relative bipolar impedance values ([0070] & [0076]; Figure 6; tissue impedance may be monitored during simultaneous bipolar ablation methods; during ablation, changes to the impedance calculated between the ablation electrodes 412 and edge electrode 420 and between ablation electrodes 412 and stem electrode 414 are analyzed).
Regarding claim 18, Richardson in view of Hettrick and Wang disclose all of the limitations of claim 17, as described above.
Richardson further discloses the processor being configured to: compare, for each ablation electrode, a change between one of the first relative bipolar impedance measurements and a subsequent corresponding relative bipolar impedance measurement; and indicate the lesion formation ([0070], [0071], & [0076]; tissue impedance may be monitored during simultaneous bipolar ablation methods; multiple impedance measurements are taken between ablation electrodes 412 and edge/ground pad electrode 420 and between ablation electrodes 412 and stem electrode 414, the changes in impedance values are analyzed to determine/indicate how much tissue has been ablated).
Richardson does not disclose the processor being configured to: compare the change between one of the first relative bipolar impedance measurements and a subsequent corresponding relative bipolar impedance measurement to a relative bipolar impedance threshold value, the relative bipolar impedance threshold value being a predetermined magnitude of a reduction in relative bipolar impedance, which reduction is the threshold value indicative of lesion formation in the tissue; and indicate the lesion formation when the magnitude of the change is equal to or greater than the relative bipolar impedance threshold value.
Wang further teaches the processor being configured to: compare the change between one of the first relative bipolar impedance measurements and a subsequent corresponding relative bipolar impedance measurement to a relative bipolar impedance threshold value, the relative bipolar impedance threshold value being a predetermined magnitude of a reduction in relative bipolar impedance, which reduction is the threshold value indicative of lesion formation in the tissue; and indicate the lesion formation when the magnitude of the change is equal to or greater than the relative bipolar impedance threshold value ([0010]-[0012]; the effectiveness of ablation is determined based on the change of impedance, such as a fall in impedance, the ablation is determined to be effective when a fall in impedance exceeds 10 to 100 ohms).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the indication of lesion formation based on relative bipolar impedance changes, as disclosed by Richardson, to include the indication of the lesion formation based on determining that the impedance changes are equal to or greater than a threshold value, as further taught by Wang, as both references and the claimed invention are directed toward devices for assessing and indicating lesion formation using impedance measurements. As disclosed by Richardson, the complex impedance and changes in impedance may be monitored before and during ablation, such that the changes in impedance can be analyzed to indicate how much tissue has been ablated ([0026], [0068], & [0071]). As disclosed by Wang, the effectiveness of the ablation can be determined based on a fall in impedance, such that the ablation is determined to be effective when a fall in impedance exceeds 10 to 100 ohms, this feature provides a safer and more effective device for delivering energy ([0008], & [0010]-[0011]). 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 indication of lesion formation based on relative bipolar impedance changes, as disclosed by Richardson, to include the indication of the lesion formation based on determining that the impedance changes are equal to or greater than a threshold value, as further taught by Wang, as such a modification would produce the predictable result of analyzing impedance measurements to determine lesion formation, while also providing an indication of the effectiveness of the ablation that leads to a safer and more effective device for delivering energy.
Regarding claim 19, Richardson discloses a system for use with performing a medical procedure, the system comprising: a balloon catheter ([0064] & [0065]; Figures 5 & 6—element 408), comprising a plurality of ablation electrodes configured to ablate tissue of patient anatomy ([0066]; Figures 5 & 6—element 412), a stem electrode and an edge electrode ([0067], [0069], & [0070]; Figures 5 & 6—elements 414 & 420; the examiner is considering the stem electrode to be sensing electrode 414 and the edge electrode to be the ground pad electrode 420), the stem electrode being disposed on the balloon catheter ([0064], [0067]; Figure 6—element 414); a processing device comprising a processor ([0027] & [0068]; Figure 1—element 18) configured to: acquire first impedance measurements between each of the ablation electrodes of the balloon catheter and an edge electrode of the balloon catheter ([0066]-[0068], [0070]; Figures 5 & 6—element 412 & 420; impedance is calculated between the ablation electrodes 412 and the ground pad 420); acquire second impedance measurements between each of the ablation electrodes of the balloon catheter and a stem electrode of the balloon catheter ([0066]-[0068], [0070]; Figures 5 & 6—element 412 & 414; impedance is calculated between the ablation electrodes 412 and sensing electrode 414); initiate the ablation of the tissue with the at least one of the plurality of ablation electrodes ([0066] & [0070]); determine, during ablation of the tissue, impedance magnitude changes by comparing at least one of the first impedance measurements and the second impedance measurements to subsequent corresponding impedance measurements acquired during the ablation ([0026], [0036], [0068], [0070] & [0071]; the impedance measurements may include complex impedance measurements; the impedance is monitored prior to and during ablation; as target tissue is ablated the change in impedance may be analyzed to determine how much tissue has been ablated; as the complex impedance may be measured and change in the complex impedance is analyzed to determine how much tissue is ablated, it is the examiners position that the changes in the complex impedance would include changes in the impedance magnitude); and indicate lesion formation ([0026], [0036], [0070] & [0071]; as target tissue is ablated the change in impedance may be analyzed to determine how much tissue has been ablated).
Richardson does not disclose the edge electrode being disposed on the balloon catheter; prior to an ablation of tissue of patient anatomy, determine a level of contact sufficiency between at least one of the plurality of ablation electrodes and the tissue based on the first impedance measurements and the second impedance measurements; initiate the ablation in response to a determination that the level of contact sufficiency is sufficient; the indicate lesion formation based on the determination that the impedance magnitude changes exceed a threshold value indicative of lesion formation in the tissue.
Hettrick discloses a system configured to acquiring first impedance measurements between each of a plurality of ablation electrodes of a catheter and a stem electrode of the catheter and acquiring second impedance measurements between each of the ablation electrodes of the catheter and an edge electrode of the catheter ([0026], & [0030]-[0034]; Figure 5—elements 124 & 200; Figure 6—element 604; the controller is configured to monitor the impedance between each of the ablation electrodes 124 and each of the reference electrodes 200; the examiner is considering the stem electrode to be a first reference electrode 200 and the edge electrode to be a second reference electrode 200); the stem electrode being disposed on the catheter and the edge electrode being disposed on the catheter ([0021] & [0031]; the reference electrodes 200 may be patch electrodes to be positioned on the patient’s body, the “reference electrodes 200 may also be carried on the catheter 102, guide catheter, guide wire, introducer, and/or a separate reference electrode catheter configured to be positioned at a desired location within the patient's vasculature”).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the edge electrode, as disclosed by Richardson, to include the edge electrode being disposed on the catheter, as taught by Hettrick, as both references and the claimed invention are directed toward ablation systems configured to measure impedance between a plurality of ablation electrodes and a plurality of reference electrodes. As disclosed by Richardson, the edge electrode may be a ground pad electrode, impedance can be measured between the ablation electrodes and the ground pad/edge electrode ([0069]). As disclosed by Hettrick, impedance may be measured between the ablation electrodes and the reference electrodes, the reference electrodes may be in the form of ground pad electrodes or alternatively may be carried on the catheter ([0026], & [0030]-[0034]). 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 edge electrode, as disclosed by Richardson, to include the edge electrode being disposed on the catheter, as taught by Hettrick, as providing an edge/reference electrode on the catheter is a known and suitable alternative to providing an edge electrode in the form of a ground pad electrode, and such a modification would produce the predictable result of providing a suitable reference electrode for use in impedance measurements during an ablation procedure.
Wang teaches a system comprising a processing device for an ablation procedure configured to prior to an ablation of tissue of patient anatomy, determine a level of contact sufficiency between at least one of the plurality of ablation electrodes and the tissue based on the first impedance measurements and the second impedance measurements; initiate the ablation in response to a determination that the level of contact sufficiency is sufficient ([0046] & [0046]; each electrode detects a contact impedance value, if the electrodes are determined to be in good contact, based on the impedance value, radio frequency energy will be delivered to ablate the lesion tissue); the indicate lesion formation based on the determination that the impedance magnitude changes exceed a threshold value indicative of lesion formation in the tissue ([0053]-[0054]; determining the effectiveness of the ablation comprises determining a change of impedance exceeds a certain amount).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the system for ablating tissue and the indication lesion formation based on impedance magnitude changes, as disclosed by Richardson, to include the system configured to prior to an ablation of tissue of patient anatomy, determine a level of contact sufficiency between at least one of the plurality of ablation electrodes and the tissue based on the first impedance measurements and the second impedance measurements, and the indicate lesion formation based on the determination that the impedance magnitude changes exceed a threshold value indicative of lesion formation in the tissue, as taught by Wang, as both references and the claimed invention are directed toward ablation devices for assessing and indicating lesion formation using impedance measurements. As disclosed by Richardson, the complex impedance and changes in impedance may be monitored before and during ablation, such that the changes in impedance can be analyzed to indicate how much tissue has been ablated ([0026], [0068], & [0071]). As disclosed by Wang, prior to ablation, the impedance measurements may be taken to detect contact between the electrodes and tissue, such that when the electrodes are indicated to be in good contact with tissue the radiofrequency energy is delivered to ablate the tissue, after the radio frequency is output impedance values are observed and recorded and the effectiveness of the ablation can be determined according to the change of impedance exceeding a predetermined value, these features provide for a safer and more effective device for delivering energy ([0008], [0053], [0054], [0096], & [0114]). 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 for ablating tissue and the indication lesion formation based on impedance magnitude changes, as disclosed by Richardson, to include the system configured to prior to an ablation of tissue of patient anatomy, determine a level of contact sufficiency between at least one of the plurality of ablation electrodes and the tissue based on the first impedance measurements and the second impedance measurements, and the indicate lesion formation based on the determination that the impedance magnitude changes exceed a threshold value indicative of lesion formation in the tissue, as taught by Wang, as such a modification would determine if the electrodes are in sufficient contact with the target tissue to begin ablation and would produce the predictable result of analyzing impedance measurements to determine lesion formation and the effectiveness of ablation, both of which features provide for a safer and more effective device for delivering energy.
Regarding claim 20, Richardson in view of Hettrick and Wang disclose all of the limitations of claim 19, as described above.
Richardson does not disclose a display device, wherein the processor is being configured to indicate the lesion formation based on the impedance magnitude changes exceeding the threshold value indicative of lesion formation in the tissue by displaying the impedance magnitude changes on the display device.
Wang further teaches a display device, wherein the processor is being configured to indicate the lesion formation based on the impedance magnitude changes exceeding the threshold value indicative of lesion formation in the tissue by displaying the impedance magnitude changes on the display device ([0010]-[0012], [0026], [0061], & [0114]-[0117]; Figure 19).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the indication of lesion formation based on impedance magnitude changes exceeding the threshold value, as disclosed by Richardson in view of Wang, to include a display device, wherein the processor is being configured to indicate the lesion formation based on the impedance magnitude changes exceeding the threshold value indicative of lesion formation in the tissue by displaying the impedance magnitude changes on the display device, as further taught by Wang, as both references and the claimed invention are directed toward ablation devices for assessing and indicating lesion formation using impedance measurements. As disclosed by Wang, output impedance values are observed, recorded, and displayed such that the effectiveness of the ablation can be determined according to the change of impedance exceeding a predetermined value, these features provide for a safer and more effective device of delivering energy ([0010]-[0012], [0061], & [0114]-[0117]). 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 indication of lesion formation based on impedance magnitude changes exceeding the threshold value, as disclosed by Richardson in view of Wang, to include a display device, wherein the processor is being configured to indicate the lesion formation based on the impedance magnitude changes exceeding the threshold value indicative of lesion formation in the tissue by displaying the impedance magnitude changes on the display device, as further taught by Wang, as such a modification would provide the user with feedback regarding the ablation procedure and ablation effectiveness.
Conclusion
Accordingly, claims 1-20 are rejected.
THIS ACTION IS MADE FINAL. 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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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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