DETAILED ACTION
This action is in response to amendments received on 7/8/2026. Claims 1-30 were previously pending. Claims 1, 12 and 23 have been amended. A complete action on the merits of claims 1-30 follows below.
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 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.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Independent Claims 1, 12 and 23 have been amended to recite the limitation “processor configured to analyze data received from the plurality of sensors by confirming ECG data from the one or more ECG electrodes with PPG data from the one or more PPG sensors, and based on the confirmed ECG data, enable delivery of the electrical pulses by the system”. It is at most unclear what is meant by “confirming ECG data from the one or more ECG electrodes with PPG data from the one or more PPG sensors”. It is unclear if each of the data received from each of these sensors are confirmed to for example show the heart beat at a specific cardiac cycle in order to enable energy delivery (based on the specification “The signal analyzer may be configured to repeatedly obtain data from the sensors, analyze the data to identify a heartbeat and a phase of a heartbeat cycle, confirm that data from each sensor is consistent with the heartbeat and phase of the heartbeat cycle, and, when data from each of the sensors is consistent, and the phase of the heartbeat cycle is a safe time period for cardiac ablation, enable the pulse generator to generate the electrical pulses” [0007]) or if data received by one or more ECG electrodes is confirmed against data received by one or more PPG sensors, which in that case, it is unclear how the data are confirmed and what means are used to confirm the data against. Clarification and appropriate correction is required.
Claims 2-11, 13-22 and 24-30 are rejected due to dependency over a rejected claim.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 7-8, 10-14, 18-19 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Sinnott (US Pub. 2020/0069367) in view of Hammer (US Pub. No. 2021/0283400) and further in view of Stewart (US Pub. No. 2016/0166310).
Regarding Claim 1, Sinnott teaches a system for delivering pulsed field ablation ([0041] and Fig. 3A) comprising:
an ablation catheter 57/120 comprising one or more electrodes 58/122, 123, 124 ([0053], [0067] and Figs. 3A-3B, 5);
a patch (Figs. 1A-1D/ patches 50-55 in Figs. 3A-3B/ 101-103 in Fig. 4/ 125-127 in Fig. 5) configured for placement on a body of a patient (Fig. 3A), the patch comprising a plurality of sensors and one or more return electrodes (sensors ECG electrode 1/21 and position sensor 7/27 and grounding or dispersion element 3/23, Figs. 1A-1D) thereon, wherein the plurality of sensors comprises one or more electrocardiogram (ECG) electrodes (ECG electrode 1/21 and dispersive electrode 3/23, [0025]-[0028] and Figs. 1A, 1C and position sensor 7, 27);
a pulse generator configured to generate electrical pulses for delivery from the one or more electrodes of the ablation catheter ([0040]-[0041], [0053], [0059] and [0067]); and
a processor configured to analyze data received from the plurality of sensors by confirming ECG data from the one or more ECG electrodes (“respiration may be monitored by changes in the magnetic electrode sensors and chest impedance from the multifunction patch array and, particularly, the ECG electrode component. The heart rhythm may be tracked with each type of beat registered. Thus, the multifunction array may be used for tracking respiration and rhythm and the influence of respiration and rhythm on the heart's position” [0071]-[0072] and [0082]);
however, does not teach one or more photoplethysmogram (PPG) sensors positioned on the patch and the processor configured to analyze data received from the plurality of sensors by confirming ECG data from the one or more ECG electrodes with PPG data from the one or more PPG sensors, and based on the confirmed ECG data enable delivery of the electrical pulses by the system as claimed.
In the same field of invention, Hammer teaches “two, or more sensors housed in the device to collect, store, and analyze biological measures about the wearer including, but not limited to, motion (e.g., accelerometers, gyroscopes, magnetometer, bend sensors), ground reaction force or foot pressure (e.g., force sensors or pressure insoles), muscle activity (e.g., EMG), cardiovascular measures (e.g., heart rate, heart rate variability (HRV), photoplethysmography (PPG), or ventricular and/or atrial dyssynchrony using electrodes to measure ECG and/or heart rhythm abnormalities), skin conductance (e.g., skin conductance response, galvanic skin response), respiratory rate, skin temperature, pupil diameter, and sleep state (e.g., awake, light sleep, deep sleep, REM)” in [0098].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add more sensors such as a photoplethysmogram (PPG) to the patch in order to collect, store, and analyze biological measures about the wearer in order to track heartbeats for better analyzing of the cardiac rhythm in view of the teachings of Hammer.
Furthermore, as best understood in view of the 112 rejection above, in the same field of invention, Stewart teaches “Determining cardiac cycle timing may further include measuring a QT interval that includes an R wave, an S wave, and a T wave, and determining the optimal time within the cardiac cycle for pulsed field energy delivery may include identifying an ST segment within the QT interval. Pulsed field energy may be delivered during the ST segment so the delivery does not induce an arrhythmia. Further, the energy delivery to the target tissue may be initiated approximately 60-120 milliseconds after an onset of the R wave and terminated before an onset of the T wave” in [0008] and also “As shown in FIG. 7, the surface electrocardiogram (ECG) may include a P wave, a Q wave, an R wave, an S wave, a T wave, and an ST segment between the S wave and the onset of the T wave. The R wave may represent an electrical stimulus as it passes through the main portion of the ventricular wall. An exemplary energy delivery timing may be at approximately 60-120 milliseconds after detection of the R wave so that the energy is delivered during at least a portion the ST segment. Energy delivery may be terminated before the onset of the T wave, regardless of what point during the ST segment at which energy delivery is initiated. This ST segment is referred to as the “delivery window” in FIG. 7. Energy may be delivered once during this time” in [0037].
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to confirm the data received by the ECG electrodes and other sensors such photoplethysmogram (PPG) in order to find “the optimal timing point for delivery of a therapeutic PFA pulse train” as Stewart teaches in [0033] and [0037].
Regarding Claim 2, Sinnott in view of Hammer teaches wherein the processor is further configured to identify a portion of a cardiac cycle of the patient in which to enable delivery of the electrical pulses (“rhythmic bursting patterns can be synchronized to heart rhythm events detected by heart rate monitors in the system, including but not limited to an electrical phase of the cardiac cycle, such as the P wave, R wave, QRS complex, ST segment, T wave, and the like” [0152] of Hammer).
Regarding Claim 3, Sinnott in view of Hammer and further in view of Stewart teaches wherein the cardiac cycle comprises a P wave, an R wave, and a T wave, and wherein the processor is configured to enable delivery of the electrical pulses during the portion of the cardiac cycle that lacks a T wave ([0033], [0037] and Fig. 7 of Stewart).
Regarding Claim 4, Sinnott in view of Hammer and further in view of Stewart teaches wherein the processor is further configured to identify the R wave of the cardiac cycle ([0152] of Hammer and [0037], Fig. 7 of Stewart).
Regarding Claim 7, Sinnott in view of Hammer teaches wherein the plurality of sensors further comprises one or more accelerometers ([0098] of Hammer).
Regarding Claim 8, Sinnott in view of Hammer teaches wherein the plurality of sensors further comprises one or more microphones (“Other types of cardiac or blood pressure sensors can also be used, such as a microphone to detect the sound of blood flow” [0161] of Hammer).
Regarding Claim 10, Sinnott teaches wherein the ablation catheter is configured to deliver the electrical pulses in a unipolar mode from the one or more electrodes (current flowing through the active electrode 58/100/122-124 to the grounding or dispersive electrode 3/23 on the patch, [0040]-[0041], [0053], [0059] and [0067]).
Regarding Claim 11, Sinnott teaches wherein the processor is further configured to manually accept input from a user ([0046]).
Regarding Claim 12, Sinnott teaches a system for delivering pulsed field ablation ([0041] and Fig. 3A) comprising:
an ablation catheter 57/120 comprising one or more electrodes 58/122, 123, 124 ([0053], [0067] and Figs. 3A-3B, 5);
a patch (Figs. 1A-1D/ patches 50-55 in Figs. 3A-3B/ 101-103 in Fig. 4/ 125-127 in Fig. 5) configured for placement on a body of a patient (Fig. 3A), the patch comprising a plurality of sensors and one or more return electrodes (grounding or dispersion element 3/23, Figs. 1A-1D) thereon, wherein the plurality of sensors comprises one or more electrocardiogram (ECG) electrodes (ECG electrode 1 and dispersive electrode 3, [0025]-[0027] and Figs. 1A, 1C and position sensor 7, 27);
a pulse generator configured to generate electrical pulses for delivery from the one or more electrodes of the ablation catheter ([0040]-[0041], [0053], [0059] and [0067]); and
a processor configured to analyze data received from the plurality of sensors by confirming ECG data from the one or more ECG electrodes (“respiration may be monitored by changes in the magnetic electrode sensors and chest impedance from the multifunction patch array and, particularly, the ECG electrode component. The heart rhythm may be tracked with each type of beat registered. Thus, the multifunction array may be used for tracking respiration and rhythm and the influence of respiration and rhythm on the heart's position” [0071]-[0072] and [0082]);
however, does not teach one or more photoplethysmogram (PPG) sensors positioned on the patch and the processor configured to analyze data received from the plurality of sensors by confirming ECG data from the one or more ECG electrodes with PPG data from the one or more PPG sensors, and based on the confirmed ECG data enable delivery of the electrical pulses by the system as claimed.
In the same field of invention, Hammer teaches “two, or more sensors housed in the device to collect, store, and analyze biological measures about the wearer including, but not limited to, motion (e.g., accelerometers, gyroscopes, magnetometer, bend sensors), ground reaction force or foot pressure (e.g., force sensors or pressure insoles), muscle activity (e.g., EMG), cardiovascular measures (e.g., heart rate, heart rate variability (HRV), photoplethysmography (PPG), or ventricular and/or atrial dyssynchrony using electrodes to measure ECG and/or heart rhythm abnormalities), skin conductance (e.g., skin conductance response, galvanic skin response), respiratory rate, skin temperature, pupil diameter, and sleep state (e.g., awake, light sleep, deep sleep, REM)” in [0098].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add more sensors such as a photoplethysmogram (PPG) to the patch in order to collect, store, and analyze biological measures about the wearer in order to track heartbeats for better analyzing of the cardiac rhythm in view of the teachings of Hammer.
Furthermore, as best understood in view of the 112 rejection above, in the same field of invention, Stewart teaches “Determining cardiac cycle timing may further include measuring a QT interval that includes an R wave, an S wave, and a T wave, and determining the optimal time within the cardiac cycle for pulsed field energy delivery may include identifying an ST segment within the QT interval. Pulsed field energy may be delivered during the ST segment so the delivery does not induce an arrhythmia. Further, the energy delivery to the target tissue may be initiated approximately 60-120 milliseconds after an onset of the R wave and terminated before an onset of the T wave” in [0008] and also “As shown in FIG. 7, the surface electrocardiogram (ECG) may include a P wave, a Q wave, an R wave, an S wave, a T wave, and an ST segment between the S wave and the onset of the T wave. The R wave may represent an electrical stimulus as it passes through the main portion of the ventricular wall. An exemplary energy delivery timing may be at approximately 60-120 milliseconds after detection of the R wave so that the energy is delivered during at least a portion the ST segment. Energy delivery may be terminated before the onset of the T wave, regardless of what point during the ST segment at which energy delivery is initiated. This ST segment is referred to as the “delivery window” in FIG. 7. Energy may be delivered once during this time” in [0037].
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to confirm the data received by the ECG electrodes and other sensors such photoplethysmogram (PPG) in order to find “the optimal timing point for delivery of a therapeutic PFA pulse train” as Stewart teaches in [0033] and [0037].
Regarding Claim 13, Sinnott in view of Hammer and further in view of Stewart teaches wherein the cardiac cycle comprises a P wave, an R wave, and a T wave, and wherein the processor is configured to enable delivery of the electrical pulses during the portion of the cardiac cycle that lacks a T wave ([0033], [0037] and Fig. 7 of Stewart).
Regarding Claim 14, Sinnott in view of Hammer and further in view of Stewart teaches wherein the processor is further configured to identify the R wave of the cardiac cycle ([0152] of Hammer and [0037], Fig. 7 of Stewart).
Regarding Claim 18, Sinnott in view of Hammer teaches wherein the plurality of sensors further comprises one or more accelerometers ([0098] of Hammer).
Regarding Claim 19, Sinnott in view of Hammer teaches wherein the plurality of sensors further comprises one or more microphones (“Other types of cardiac or blood pressure sensors can also be used, such as a microphone to detect the sound of blood flow” [0161] of Hammer).
Regarding Claim 21, Sinnott teaches wherein the ablation catheter is configured to deliver the electrical pulses in a unipolar mode from the one or more electrodes (current flowing through the active electrode 58/100/122-124 to the grounding or dispersive electrode 3/23 on the patch, [0040]-[0041], [0053], [0059] and [0067]).
Regarding Claim 22, Sinnott teaches wherein the processor is further configured to manually accept input from a user ([0046]).
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sinnott in view of Hammer and Stewart as applied above and further in view of Toth (US Pub. No. 2017/0231490).
Regarding Claims 5 and 15, Sinnott teaches the use of one PPG sensor, but not wherein the one or more PPG sensors comprises three or more PPG sensors.
In the same field of invention, Toth teaches “one or more photoplethysmographic (PPG) sensors. The PPG sensor may be directed towards one or more tissue sites on the face, neck, head, of the subject (e.g. an eye, a retina, an ocular tissue, a nose, a nostril, a nasal lining, an ear lobe, etc.). The PPG sensor may be advantageous for capturing one or more cardiovascular parameters like blood oxygen saturation level, heart pulse rate, respiratory rate, bilirubin, or the like in the target tissues” [0094]. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use a plurality of photoplethysmogram (PPG) sensors in order to better sense the heartrate of the subject for a more precise procedure. Furthermore, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. V Bemis Co., 193 USPQ 8.
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Sinnott in view of Hammer and Stewart as applied above and further in view of Bort (US Pub. No. 2022/0344025).
Regarding Claim 6, Sinnott teaches providing one ECG electrode on each patch and not wherein the one or more ECG electrodes comprises three or more ECG electrodes.
In the same field of invention Bort teaches the use of multiple ECG sensors in [0055], [0119] and [0121] and also shows more than three ECG sensors on the patch in various figures. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add multiple ECG sensors on the patch for better reading and monitoring the cardiac activity during treatment.
Claims 9, 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sinnott in view of Hammer and Stewart as applied above and further in view of Viswanathan (US Pub. No. 2019/0231421).
Regarding Claims 9, 17 and 20, Sinnott in view of Hammer teaches the invention as applied above, but is silent in teaching wherein the electrical pulses have a voltage of at least 15 kV and wherein the one or more return electrodes comprises four return electrodes.
In the same field of cardiac ablation, Viswanathan teaches the use of "one or more return electrodes may be disposed on a skin of a patient (1200)" [0318], Figs. 12A-B and further teaches applying a high pulse for cardiac ablation such as "the voltage amplitude of the pulse (2100) ca be in the range from about 400 volts, about 1,000 volts, about 5,000 volts, about 10,000 volts about 15,000 volts, including all values and sub ranges in between" [0339].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use more than one return electrodes on the patch and use electrical pulses having a voltage of at least 15 kV for the treatment procedure in view of the teachings of Viswanathan. Furthermore, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. V Bemis Co., 193 USPQ 8.
Claims 23-26 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Sinnott in view of Hammer, Stewart, Bort and further in view of Toth.
Regarding Claim 23, Sinnott teaches a system for delivering pulsed field ablation ([0041] and Fig. 3A) comprising:
an ablation catheter 57/120 comprising one or more electrodes 58/122, 123, 124 ([0053], [0067] and Figs. 3A-3B, 5);
a patch (Figs. 1A-1D/ patches 50-55 in Figs. 3A-3B/ 101-103 in Fig. 4/ 125-127 in Fig. 5) configured for placement on a body of a patient (Fig. 3A), the patch comprising a plurality of sensors and four return electrodes (grounding or dispersion element 3/23, Figs. 1A-1D) thereon, wherein the plurality of sensors comprises [four] electrocardiogram (ECG) electrode[s] (ECG electrode 1 and dispersive electrode 3, [0025]-[0027] and Figs. 1A, 1C and position sensor 7, 27);
a pulse generator configured to generate electrical pulses for delivery from the one or more electrodes of the ablation catheter ([0040]-[0041], [0053], [0059] and [0067]); and
a processor configured to analyze data received from the plurality of sensors by confirming ECG data from the one or more ECG electrodes (“respiration may be monitored by changes in the magnetic electrode sensors and chest impedance from the multifunction patch array and, particularly, the ECG electrode component. The heart rhythm may be tracked with each type of beat registered. Thus, the multifunction array may be used for tracking respiration and rhythm and the influence of respiration and rhythm on the heart's position” [0071]-[0072] and [0082]);
however, does not teach one or more photoplethysmogram (PPG) sensors positioned on the patch and the processor configured to analyze data received from the plurality of sensors by confirming ECG data from the one or more ECG electrodes with PPG data from the one or more PPG sensors, and based on the confirmed ECG data enable delivery of the electrical pulses by the system as claimed.
In the same field of invention, Hammer teaches “two, or more sensors housed in the device to collect, store, and analyze biological measures about the wearer including, but not limited to, motion (e.g., accelerometers, gyroscopes, magnetometer, bend sensors), ground reaction force or foot pressure (e.g., force sensors or pressure insoles), muscle activity (e.g., EMG), cardiovascular measures (e.g., heart rate, heart rate variability (HRV), photoplethysmography (PPG), or ventricular and/or atrial dyssynchrony using electrodes to measure ECG and/or heart rhythm abnormalities), skin conductance (e.g., skin conductance response, galvanic skin response), respiratory rate, skin temperature, pupil diameter, and sleep state (e.g., awake, light sleep, deep sleep, REM)” in [0098].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add more sensors such as a photoplethysmogram (PPG) to the patch in order to collect, store, and analyze biological measures about the wearer in order to track heartbeats for better analyzing of the cardiac rhythm in view of the teachings of Hammer.
Furthermore, as best understood in view of the 112 rejection above, in the same field of invention, Stewart teaches “Determining cardiac cycle timing may further include measuring a QT interval that includes an R wave, an S wave, and a T wave, and determining the optimal time within the cardiac cycle for pulsed field energy delivery may include identifying an ST segment within the QT interval. Pulsed field energy may be delivered during the ST segment so the delivery does not induce an arrhythmia. Further, the energy delivery to the target tissue may be initiated approximately 60-120 milliseconds after an onset of the R wave and terminated before an onset of the T wave” in [0008] and also “As shown in FIG. 7, the surface electrocardiogram (ECG) may include a P wave, a Q wave, an R wave, an S wave, a T wave, and an ST segment between the S wave and the onset of the T wave. The R wave may represent an electrical stimulus as it passes through the main portion of the ventricular wall. An exemplary energy delivery timing may be at approximately 60-120 milliseconds after detection of the R wave so that the energy is delivered during at least a portion the ST segment. Energy delivery may be terminated before the onset of the T wave, regardless of what point during the ST segment at which energy delivery is initiated. This ST segment is referred to as the “delivery window” in FIG. 7. Energy may be delivered once during this time” in [0037].
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to confirm the data received by the ECG electrodes and other sensors such photoplethysmogram (PPG) in order to find “the optimal timing point for delivery of a therapeutic PFA pulse train” as Stewart teaches in [0033] and [0037].
In addition, in the same field of invention Bort teaches the use of multiple ECG sensors in [0055], [0119] and [0121] and also shows more than three ECG sensors on the patch in various figures. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add multiple ECG sensors on the patch for better reading and monitoring the cardiac activity during treatment.
Moreover, in the same field of invention, Toth teaches “one or more photoplethysmographic (PPG) sensors. The PPG sensor may be directed towards one or more tissue sites on the face, neck, head, of the subject (e.g. an eye, a retina, an ocular tissue, a nose, a nostril, a nasal lining, an ear lobe, etc.). The PPG sensor may be advantageous for capturing one or more cardiovascular parameters like blood oxygen saturation level, heart pulse rate, respiratory rate, bilirubin, or the like in the target tissues” [0094]. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use a plurality of photoplethysmogram (PPG) sensors in order to better sense the heartrate of the subject for a more precise procedure. Furthermore, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. V Bemis Co., 193 USPQ 8.
Regarding Claim 24, Sinnott in view of Hammer teaches wherein the processor is further configured to identify a portion of a cardiac cycle of the patient in which to deliver the electrical pulses (“rhythmic bursting patterns can be synchronized to heart rhythm events detected by heart rate monitors in the system, including but not limited to an electrical phase of the cardiac cycle, such as the P wave, R wave, QRS complex, ST segment, T wave, and the like” [0152] of Hammer).
Regarding Claim 25, Sinnott in view of Hammer and further in view of Stewart teaches wherein the cardiac cycle comprises a P wave, an R wave, and a T wave, and wherein the processor is configured to enable delivery of the electrical pulses during the portion of the cardiac cycle that lacks a T wave ([0033], [0037] and Fig. 7 of Stewart).
Regarding Claim 26, Sinnott in view of Hammer and further in view of Stewart teaches wherein the processor is further configured to identify the R wave of the cardiac cycle ([0152] of Hammer and [0037], Fig. 7 of Stewart).
Regarding Claim 28, Sinnott teaches wherein the ablation catheter is configured to deliver the electrical pulses in a unipolar mode from the one or more electrodes (current flowing through the active electrode 58/100/122-124 to the grounding or dispersive electrode 3/23 on the patch, [0040]-[0041], [0053], [0059] and [0067]).
Regarding Claim 29, Sinnott in view of Hammer teaches wherein the plurality of sensors further comprises one or more of an accelerometer or a microphone (“Other types of cardiac or blood pressure sensors can also be used, such as a microphone to detect the sound of blood flow” [0161] of Hammer).
Regarding Claim 30, Sinnott teaches wherein the processor is further configured to manually accept input from a user ([0046]).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Sinnott in view of Hammer, Stewart, Bort, Toth as applied above and further in view of Viswanathan.
Regarding Claim 27, Sinnott in view of Hammer teaches the invention as applied above, but is silent in teaching wherein the electrical pulses have a voltage of at least 15 kV.
In the same field of cardiac ablation, Viswanathan teaches applying a high pulse for cardiac ablation such as "the voltage amplitude of the pulse (2100) ca be in the range from about 400 volts, about 1,000 volts, about 5,000 volts, about 10,000 volts about 15,000 volts, including all values and sub ranges in between" [0339].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to use electrical pulses having a voltage of at least 15 kV for the treatment procedure in view of the teachings of Viswanathan.
Response to Arguments
Applicant’s arguments, see pages 7-9, filed 7/8/2026, with respect to the rejection(s) of independent claims 1, 12 and 23 under Sinnott in view of Hammer have been fully considered and are persuasive. However, as the amended section was a new limitation added not previously rejected, upon further consideration, a new ground(s) of rejection is made in view of Stewart as best understood in view of the 112 rejection above.
Conclusion
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 extension fee 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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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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