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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 18, 2024 has been entered.
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.
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 1-3, 5, 7-12, 23 and 24 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, the term “…including at least one signal of the CMAP signal and the accelerometer signal,” is vague. It is unclear what a signal of a signal connotes. It is noted that the expression “at least one” also suggests that only one of the CMAP or accelerometer signal may be displayed.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 8, 9, 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Franceschi (2011) in view of Kowalski (Pub. No. 2015/0057563 previously cited) and Cho et al. (Cho: Pub. No. 2013/0109994).
Regarding claim 1, Franceschi teaches a method of monitoring a patient for phrenic nerve collateral damage during a cardiac ablation procedure (pg. 1068, The introduction discusses the monitoring of the phrenic nerve during a cryoablation procedure), the method comprising: stimulating the phrenic nerve (the step of stimulating the phrenic nerve can be seen in the second column of the paper where “the right phrenic nerve was paced (60 beats/minute, 10V 2.9ms) using a quadripolar 5-F catheter… in the superior vena cava”, and in the description of Fig 1 this is further stated)); measuring at least one from the group consisting of compound motor action potential (CMAP) and an accelerometer signal generated in response to the stimulating of the phrenic nerve (On the front page second column, CMAP signals are measured during the procedure: “To record right diaphragmatic CMAPs, 2 standard surface electrodes were positioned on the thorax and spaced 16 cm apart, one 5 cm above the xiphoid process and the second along the right costal margin (Figure 1A). These electrodes were connected to a central computerized electrophysiology workstation”); displaying on a display real-time data, the real-time data including the at least one from the group consisting of the measured CMAP and accelerometer signals (First page second column, the electrode outputs are coupled to an EP workstation, an EP workstation will present data from electrodes in real time); and simultaneously displaying on the display long-term trend data, the long-term trend data being associated with the at least one signal (Fig 1 display a real-time data set from to the CMAP signal and Fig 3 shows a long-term (over many cycles in comparison to that of Fig 1) trend data for the CMAP signal over the course of the ablation procedure; these data streams may be presented in real-time on the EP workstation as noted above).
Franceschi does not teach explicitly wherein the system includes a controller to display the data (Franceschi teaches an EP console may be used to display the measurements of CMAP signals but does not explicitly disclose what components are providing input for the displays, one of ordinary skill may infer that a “controller” like a microprocessor is present and controlling the displaying of data but it is not explicitly described) and wherein the controller performs steps of automatically generating at least one of an audible alert and a visual alert when a first threshold is reached for a feature of the at least one signal in the real-time data or in the long-term data. Franceschi also does not explicitly include the step of measuring a CMAP signal and an accelerometer signal generated in response to the stimulating of the phrenic nerve.
Kowalski teaches a method of CMAP monitoring comprising a controller that may displaying on a display real-time data, the real-time data including the at least one signal ([0040] “Data may then be output by the microcontroller 52 to a display 110, to an alert device 112 (for example, one or more LEDs of a visual alert device or a speaker of an audible alert device), to the console 30, or to a data storage device 114.” Fig 9 & 10 show a data stream that may be part of the data sent to be shown on a display); and with the controller, automatically generating at least one of an audible alert and a visual alert when a first threshold is reached for a feature of the at least one signal in the data ([0030] alerts may be and of audio alerts, visual alerts or low amp alerts; [0036] “If .DELTA. is greater than the predetermined threshold percentage, the processing device 26 will generate an alert for the operator. The operator may manually enter a desired threshold percentage for an alert to be generated.”, thus a method is taught wherein the measured CMAP signal may trigger alerts when it increase/decreases past a set threshold).
It would be obvious to one of ordinary skill in the art at the time of invention to have modified the method of CMAP monitoring of Franceschi with the controller and CMAP monitoring alert system of Kowalski because “By alerting the operator to possible phrenic nerve impairment, manifested by a significant measurable decrease in CMAP amplitude during the treatment procedure, the processing device 26 may allow the physician to intervene before phrenic nerve injury occurs, reducing procedural risk and potential patient sequelae.” [0038]
Regarding the measurement of an accelerometer signal, Cho discloses in a substantially related method/device measuring a compound motor action potential (CMAP) signal and an accelerometer signal generated in response to the stimulating of the phrenic nerve (Fig. 8, element 102; pars. 0035 and 0037); and with a controller (32), automatically generating at least one of an audible alert and a visual alert when a first threshold is reached for a feature of the at least one signal in the real-time data or in the long-term data (Fig. 8, element 118; par. 0038). It would have been obvious to include such a measurement in the method/device of Franceschi as such a parameter allows one to determine the effect of ablation on the phrenic nerve, such that one may alert the physician, modify or terminate stimulation to prevent damage to the nerve.
Regarding claim 2, Franceschi teaches wherein displaying the real-time data includes displaying a rolling window of the real time data (Fig 1B shows the CMAP recording over several cycles, this signal is being displayed on an EP workstation, as a real-time signal is displayed, the window will remain the same size, and continuously update to display additional data).
Regarding claim 3, Franceschi teaches wherein the rolling widow includes a predetermined number of previous cycles of phrenic nerve stimulation (Fig 1B shows the CMAP recording over several cycles, this signal is being displayed on an EP workstation, a predetermined number of cycles is shown (in the case of Fig 1B 3 cycles)).
Regarding claim 8, Franceschi teaches displaying the real-time data (Fig 1) and separately displaying a pre-ablation baseline peak amplitude (Fig 3, the long-term data shows displaying the pre-ablation levels). Kowalski teaches wherein displaying the real-time data further includes displaying a pre-ablation baseline peak amplitude (Fig 10, [0036] a baseline of a peak amplitude CMAP signal is seen on the alongside the real-time signal to compare to the real-time measurements, this may be displayed as the real-time data as taught above in Franceschi). It would be obvious to one of ordinary skill in the art at the time of invention to have modified the system of Franceschi to include a baseline peak amplitude to compare to the real-time data because the deviation from the peak amplitude may be useful to determine if “phrenic nerve impairment occurs as the result of treatment by the treatment device” [0036].
Regarding claim 9, Franceschi teaches the simultaneously displaying on the display the long-term trend data includes displaying a peak amplitude from previous cycle of phrenic nerve stimulation (Fig 1 and Fig 3, while fig 1 displays the real-time cycle of action potentials, Fig 3 displays a CMAP amplitude data from all cycles from the beginning of the ablation, including peak amplitudes from previous cycles).
Regarding claim 23, Franceschi does not teach with the controller, automatically terminating or modifying the cardiac ablation procedure when a second threshold is reached for at least one of the peak amplitudes in the real- time data or in the long-term data. Kowalski teaches wherein the controller, automatically terminating or modifying the cardiac ablation procedure ([0031] “the processing device 26 may automatically adjust operation of the console 30, such as increasing the temperature of a cryoballoon, stopping the application of radiofrequency energy by the treatment device, or the like”) when a second threshold is reached for at least one of the peak amplitudes in the real- time data or in the long-term data ([0039]-[0042] thresholds in the measured data may be set and the controller/processor may be configured to automatically modify the ablation, i.e. shutoff, if certain thresholds in the measure CMAP signal are met; [0010] “The processing device may automatically adjust the amount of heat removed from the area of tissue by the ablation device (for example, interrupting or adjusting the amount of cryogenic fluid circulated within the ablation device and thereby interrupting the ablation of tissue) in response to the comparisons performed by the microcontroller.”). It would be obvious to one of ordinary skill in the art at the time of invention to have modified the method of Franceschi to make use of the automatic adjustments of ablation based on the CMAP signal because “This automated method would reduce physician distraction, reduce procedure fluoroscopy time, and ensure timely identification of transient injury, leading to prevention of long-term phrenic injury.” [0007]
Regarding claim 24, Franceschi does not explicitly teach a generator, delivering a radiofrequency energy or a pulsed-field energy to a plurality of electrodes positioned proximate to a cardiac tissue of the patient, wherein the automatically terminating or modifying the cardiac ablation procedure comprises terminating or modifying the delivering of the radiofrequency energy or the pulsed- field energy to the plurality of electrodes. Kowalski teaches a method with a generator ([0032] “the treatment device 28 may be a focal catheter having one or more radiofrequency electrodes, a basket catheter having a plurality of electrodes affixed to a plurality of splines, or may be any other device capable of ablating cardiac tissue, including, for example, by cryoablation, radiofrequency ablation, ultrasound ablation, laser ablation, hot balloon ablation, or combinations thereof.”), delivering a radiofrequency energy or a pulsed-field energy to a plurality of electrodes positioned proximate to a cardiac tissue of the patient ([0004] technique is directed towards treatment of cardiac tissue; [0031] application of radiofrequency may deliver therapy), wherein the automatically terminating or modifying the cardiac ablation procedure comprises terminating or modifying the delivering of the radiofrequency energy or the pulsed- field energy to the plurality of electrodes ([0031] “the processing device 26 may automatically adjust operation of the console 30, such as increasing the temperature of a cryoballoon, stopping the application of radiofrequency energy by the treatment device, or the like”; [0010] “The processing device may automatically adjust the amount of heat removed from the area of tissue by the ablation device (for example, interrupting or adjusting the amount of cryogenic fluid circulated within the ablation device and thereby interrupting the ablation of tissue) in response to the comparisons performed by the microcontroller.”). It would be obvious to one of ordinary skill in the art at the time of invention to have modified the method of Franceschi to make use of the automatic adjustments of ablation based on the CMAP signal because “This automated method would reduce physician distraction, reduce procedure fluoroscopy time, and ensure timely identification of transient injury, leading to prevention of long-term phrenic injury.” [0007]
Claims 5, 7 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Franceschi (2011) in view of Kowalski (US 20150057563 A1) and Cho as applied to claims 1-3, 8, 9, 23 and 24 above, and further in view of Eshelman (US 20150145691 A1).
Regarding claim 5, Franceschi teaches wherein the real-time data is superimposed with predetermined signal feature extraction markers (Fig 1B maxima of the CMAP are marked, superimposed on the signal). Franceschi does not teach wherein the automatically generating the visual alert comprises color coding the predetermined signal feature extraction markers using at least three different colors indicating different respective levels of degradation of the CMAP signal. Eshelman teaches a method of displaying indicators of physiologic conditions (abstract) wherein the predetermined signal feature extraction markers are color coded (Fig 9, [0091] a GUI may render signals from a patient as a trend line which may be color coded according to different values of the trend (green, yellow, red)) and the predetermined signal feature extraction markers using at least three different colors indicating different respective levels of degradation of the CMAP signal ([0091] three colors green, red, yellow may be used to show different levels of degradation of the CMAP signals from the disclosures of Franceschi and Kowalski). It would be obvious to one of ordinary skill in the art at the time of invention to have modified the system of Franceschi to make use of color-coded markers for physiologic data as taught in Eshelman because color values may emphasize or delineate changes to measured patient parameters (peak amplitude areas) ([0089]-[0092] color coding is used to highlight data that may be of interest to the clinician).
Regarding claim 7, Franceschi teaches placing markers on signal features (Fig 1) and shows peaks of CMAP data (Figs 1 and 3) and, but does not specifically teach wherein the predetermined signal feature extraction markers are correlated to a predetermined percentage threshold from peak amplitude. Eshelman teaches a method of displaying indicators of physiologic conditions (abstract) wherein the predetermined signal feature extraction markers are correlated to a predetermined percentage threshold from peak amplitude (Eshelman discusses displaying indicators on patient data to show a trend or deterioration over time [0078]; the display system is described to make use of signal thresholding to determine is an indicator/marker should be displayed on the GUI with the data stream [0079]-[0089]; and that predetermined thresholds may be used to determine marking the data [0090][0091] Fig 9,(a predetermined threshold of 0-33% is used to mark with green, 33-66% for yellow and 66-100 for red)). It would be obvious to one of ordinary skill in the art at the time of invention to have modified the system of Franceschi to make use of predetermined percentage thresholds to determine marker/indicator placements as taught in Eshelman because this allows for a clinician observing the data to see highlights deviations from the baseline in real-time ([0090]-[0091] by changing a color as an indicator based on a percentage change in the value, the deterioration of the measured signal is easily visualized and can quickly be acted upon).
Regarding claims 10 and 11, Franceschi teaches placing markers on signal features/peaks (Fig 1), but does not teach wherein the markers are color coded and wherein each color-coded peak amplitude is correlated to a predetermined percentage threshold from a baseline peak amplitude. Eshelman teaches a method of displaying indicators of physiologic conditions (abstract) wherein the predetermined signal feature extraction markers are color coded (Fig 9, [0091] a GUI may render signals from a patient as a trend line which may be color coded according to different values of the trend (green, yellow, red)) and wherein each color-coded marker is correlated to a predetermined percentage threshold from a baseline (Eshelman discusses displaying indicators on patient data to show a trend or deterioration over time [0078]; the display system is described to make use of signal thresholding to determine is an indicator/marker should be displayed on the GUI with the data stream [0079]-[0089]; and that predetermined thresholds may be used to determine marking the data [0090][0091] Fig 9,(a predetermined threshold of 0-33% is used to mark with green, 33-66% for yellow and 66-100 for red). It would be obvious to one of ordinary skill in the art at the time of invention to have modified the system of Franceschi to make use of color-coded markers for physiologic data peaks as taught in Eshelman because color values may emphasize or delineate changes to measured patient parameters (peak amplitude areas) ([0089]-[0092] color coding is used to highlight data that may be of interest to the clinician) and allows for a clinician observing the data to see highlights deviations from the baseline in real-time ([0090]-[0091] by changing a color as an indicator based on a percentage change in the value, the deterioration of the measured signal is easily visualized and can quickly be acted upon).
Regarding claim 12, Franceschi teaches displaying with the long-term trend data a point at which the cardiac ablation procedure is initiated (Fig 3, the descriptions of fig 3 notes the 0 second mark notes the beginning of the ablation, by starting the long-term trend with that point, they are displaying the data point where ablation is initiated).
Claims 13, 17, 19, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Franceschi (2011) in view of Kowalski (Pub. No. 2015/0057563 previously cited) and Tran (Pub. No. 2008/0001735).
Regarding claim 13, Franceschi teaches a method of monitoring a patient for phrenic nerve collateral damage during a cardiac ablation procedure (pg. 1068, The introduction discusses the monitoring of the phrenic nerve during a cryoablation procedure), the method comprising: stimulating the phrenic nerve (the step of stimulating the phrenic nerve can be seen in the second column of the paper where “the right phrenic nerve was paced (60 beats/minute, 10V 2.9ms) using a quadripolar 5-F catheter… in the superior vena cava”, and in the description of Fig 1 this is further stated)); measuring a compound motor action potential (CMAP) signal generated in response to the stimulating of the phrenic nerve (On the front page second column, CMAP signals are measured during the procedure: “To record right diaphragmatic CMAPs, 2 standard surface electrodes were positioned on the thorax and spaced 16 cm apart, one 5 cm above the xiphoid process and the second along the right costal margin (Figure 1A). These electrodes were connected to a central computerized electrophysiology workstation”); displaying on a display, a rolling window of real-time data including a predetermined number of previous cycles of phrenic nerve stimulation, the real-time data including the measured CMAP signal (First page second column, the electrode outputs are coupled to an EP workstation, an EP workstation will present data from electrodes in real time; Fig 1B shows the CMAP recording over several cycles, this signal is being displayed on an EP workstation, as a real-time signal is displayed, the window will remain the same size, and continuously update to display additional data, a predetermined number of cycles is shown (in the case of Fig 1B 3 cycles)); and simultaneously displaying on the display long-term trend data (Fig 1 display a real-time data set from to the CMAP signal and Fig 3 shows a long-term (over many cycles) trend data for the CMAP signal over the course of the ablation procedure; these data streams may be presented in real-time on the EP workstation as noted above), the long-term trend data being associated with the measured CMAP signal and including a peak amplitude from the previous cycles of phrenic nerve stimulation (Fig 1 show marked peak amplitudes of the cycles of stimulation, and Fig 3 additionally show the CMAP amplitude over a long term with peak amplitudes from the stimulation/ablation).
Franceschi does not teach explicitly wherein the system includes a controller to display the data (Franceschi teaches an EP console may be used to display the measurements of CMAP signals but does not explicitly disclose what components are providing input for the displays, one of ordinary skill may infer that a “controller” like a microprocessor is present and controlling the displaying of data but it is not explicitly described) and wherein the controller performs steps of automatically generating at least one of an audible alert and a visual alert when a first threshold is reached for a feature of the at least one signal in the real-time data or in the long-term data.
Kowalski teaches a method of CMAP monitoring comprising a controller that may displaying on a display real-time data, the real-time data including the at least one signal ([0040] “Data may then be output by the microcontroller 52 to a display 110, to an alert device 112 (for example, one or more LEDs of a visual alert device or a speaker of an audible alert device), to the console 30, or to a data storage device 114.” Fig 9 & 10 show a data stream that may be part of the data sent to be shown on a display); and with the controller, automatically generating at least one of an audible alert and a visual alert when a first threshold is reached for a feature of the at least one signal in the data ([0030] alerts may be and of audio alerts, visual alerts or low amp alerts; [0036] “If .DELTA. is greater than the predetermined threshold percentage, the processing device 26 will generate an alert for the operator. The operator may manually enter a desired threshold percentage for an alert to be generated.”, thus a method is taught wherein the measured CMAP signal may trigger alerts when it increase/decreases past a set threshold).
It would be obvious to one of ordinary skill in the art at the time of invention to have modified the method of CMAP monitoring of Franceschi with the controller and CMAP monitoring alert system of Kowalski because “By alerting the operator to possible phrenic nerve impairment, manifested by a significant measurable decrease in CMAP amplitude during the treatment procedure, the processing device 26 may allow the physician to intervene before phrenic nerve injury occurs, reducing procedural risk and potential patient sequelae.” [0038]
Furthermore, regarding the newly added material pertaining to feature extraction using a function selected from the group consisting of Fourier transform, a wavelet content extraction within a frequency band, and a Bayesian network algorithm, while Franceschi determines peak amplitudes, the extraction of features using functions such as the Fourier transform, wavelet content extraction within a frequency band, and a Bayesian network algorithm is not discussed. The applicant however discloses that a variety of different well-known functions or methods of analysis may be utilized including peak detection, Fourier or wavelet content and Bayesian networks (par. 0038), thus suggesting the techniques are obvious variants of each other. Tran echoes this teaching and discloses an EMG monitoring system wherein it is taught that EMG features can be extracted to gain information on a host of different conditions including the condition of the nervous system using Fourier transforms, wavelet transforms, statistical measures, etc. (pars. 0381, 0383, 0385, 0386). Given that the mechanism used for feature extraction is not critical and given that the claimed mechanisms are all old and well-known in the art, the particular feature extraction method used would have been considered a matter of obvious design to those of ordinary skill in the art, dependent upon the particular feature one is looking to extract.
The rejection of claims 17, 19, 21 and 22 parallels the rejection of claims 8, 12, 23 and 24 above.
Claims 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Franceschi (2011) in view of Kowalski (US 20150057563 A1) and Tran as applied to claims 13, 17, 19, 21 and 22 above, and further in view of Eshelman (US 20150145691 A1).
The rejection of claim 14 and 16 parallels the rejection of claims 5 and 7 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Drongelen discloses panel displays for medical monitoring systems where EMG and trend data may be simultaneously displayed, and includes a rolling window allowing a user to look back at previous waveforms.
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/KENNEDY SCHAETZLE/ Primary Examiner, Art Unit 3796
KJS
August 23, 2025