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
Currently claims 1, 2, 5-13, 14-17, 19-20, 77-79, and 81-85 are currently pending.
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, 2, 6-11, 15, 16, 19, 79, and 83-85 are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz et al., (US20090264750A1) in view of Nagata et al., (US20050182333A1) and further in view of Lu et al., (US20180256056A1) and Massarwa (US20130241929A1).
Regarding claim 1, Markowitz teaches a method, comprising: receiving an electrogram measured by one or more first electrodes of a catheter positioned at locations within a patient's heart (fig. 26A an mapping catheter 100 may have electrodes to measure electrograms (EGM) from within the heart [0300]);
receiving an electrophysiological signal measured by second electrodes residing at respective substantially fixed locations relative to the patient's heart (fig. 26 electrodes 572 a-c are used for an electrocardiogram (ECG) and are at fixed locations relative to the heart [0299]), wherein the second electrodes are different from the first electrodes (fig. 26 electrodes on the catheter are different than the electrodes 572 [0299]-[0300]);
determining one or more signal features of the electrophysiological signal, in which each feature is indicative of cardiac electrical activity associated with a respective cardiac region ([0299] different features of the cardiac electrical cycle can be identified such as P-wave, R-wave, T-wave, and would be associated with a cardiac region; [0301] the P-wave indicates that the electrode of the catheter is in the superior vena cava (SVC) or right atrium (RA));
comparing the one or more signal features of the electrophysiological signal with one or more temporally aligned signal features of the electrogram (fig. 27A-D the timings of the ECG and electrogram are compared [0301]) to identify a cardiac region indicative of a respective current location of the one or more first electrodes within the patient's heart ([0301] “When the spike 581 a 1 of the EGM 580 a occurs coincident in time or before the P-Wave spike 583 a 1 of the ECG 582 a, it is an indication that the electrode measuring the EGM is in the SVC or RA”; the spike would indicative of the electrode’s current position during the spike); and
on a graphical user interface (fig. 28 the map points on the display may be illustrated in different colors [0306]), displaying visual indicia based on the identified cardiac region (fig. 28 there are shapes that are used to illustrate the sections of the heart [0306]),
wherein displaying the visual indicia includes at least a portion of a representation of the patient's heart (fig. 28 the shapes are for portions of the heart [0306]).
However, Markowitz is silent regarding wherein coloring at least a portion of a representation of the patient’s heart based on the identified cardiac region.
In the same electrophysiological field of endeavor, Nagata teaches coloring at least a portion of a representation of the patient’s heart based on the identified cardiac region ([0122] when the identified value of the right ventricle is an abnormal value for the right ventricle, the right ventricle portion flashes red).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the shapes of Markowitz with the coloring of Nagata, as this would help users intuitively understand which portion of the heart relates to the identified values (see Nagata [0123]).
However, the combination of references are silent regarding on a graphical user interface, displaying visual indicia, indicative of the respective current location of the one or more first electrodes.
In the same electrophysiological field of endeavor, Lu teaches a graphical user interface (fig. 1a display 27 [0005]), displaying visual indicia, indicative of the respective current location of the one or more first electrodes ([0005] the display 27 is used to display visual indicia to track the real-time current location of the electrode catheter in the heart).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Markowitz with the display of Lu, as this would result in a simulated output that more accurately corresponds to what would be experienced by a health care professional when mapping or performing a procedure on a patient (see Lu [0047]).
However, the combination of references are silent regarding receiving a user input associated with a selection of a treatment region in the patient's heart and coloring at least a portion of a representation of the patient's heart based on whether the identified cardiac region corresponds to the selected treatment region different from the selected treatment region.
In the same mapping of a body organ field of endeavor, Massarwa teaches receiving a user input associated with a selection of a treatment region in the patient's heart ([0014] subgroups are selected from an ablation site [0064] professional 28 assigns values for each element of each subgroup via a GUI on the screen using pointing device; [0069] ablation sites are added, and rendered to be visible; [0029] the imaged body organ is typically the heart) and coloring at least a portion of a representation of the patient's heart based on whether the identified cardiac region corresponds to the selected treatment region different from the selected treatment region ([0060] a subgroup is assigned a respective visibility parameter, and for a selected subgroup, the value of its visibility parameter determines a relative visibility of the sub group in relation to the other sub-groups, such as transparency; [0069] the chart may incorporate a region of the chart wherein ablation sites are to be rendered visible or not).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify modified Markowitz with the visibility system of Massarwa, as this would improve the comprehension of the information (see Massarwa [0002]).
Regarding claim 2, modified Markowitz teaches the method of claim 1, wherein Markowitz teaches displaying the visual indicia includes providing the visual indicia on the representation of the patient's heart displayed on the graphical user interface (fig. 28 the display 58 can include “markings can be used to illustrate the right atrium, such as a label RA′, the right ventricle, such as the label RV, pulmonary artery, such as a label PA′, tricuspid valve TCV′, and the pulmonic valve PV′.” [0306]).
Regarding claim 6, modified Markowitz teaches the method of claim 1, wherein Markowitz teaches comparing the one or more signal features to identify the cardiac region ([0300] the signals from the ECG and the EGM are used to identify locations of the mapping catheter, which the catheter would be in a region of the heart )includes determining whether the respective one or more of the locations of the one or more first electrodes corresponds to at least one predetermined type of cardiac region (fig. 27A-D “various portions of a recorded ECG, such as the P-wave, can be matched or aligned in time to measurements or deflections with EGM's measured with the mapping catheter 100 to determine the location of the mapping catheter 100.” [0300]; [0301]-[0304] examples of how the comparison may be used to determine the location of the catheter).
Regarding claim 7, modified Markowitz teaches the method of claim 6, wherein Markowitz further teaches displaying the visual indicia (fig. 28 shapes [0306]) includes displaying only those portions of the representation of the patient's heart on the graphical user interface corresponding to the at least one predetermined type of cardiac region (fig. 27c when the EGM line two spikes, the electrode is in the tricuspid valve (TCV) or the pulmonary valve (PV) [0303]; fig. 28B the TCV/PV is shown; [0307] “including an algorithm, to assist in identifying, automatically or with input from the user 22, various portions of the heart 80”, therefore in this situation, only the portions representing the heart would be shown).
Regarding claim 8, modified Markowitz teaches the method of claim 6, wherein Markowitz further teaches comparing the one or more signal features to identify the cardiac region includes determining whether the respective one or more of the locations of the one or more first electrodes corresponds to an atrium of the patient's heart (fig. 26A and fig. 28 the catheter may be used to identify the anatomy such as the right atrium [0298]).
Regarding claim 9, modified Markowitz teaches the method of claim 6, wherein Markowitz further teaches comparing the one or more signal features to identify the cardiac region includes determining whether the respective one or more of the locations of the one or more first electrodes corresponds to a ventricle of the patient's heart (fig. 26A and fig. 28 the catheter may be used to identify the anatomy such as the right ventricle [0298]).
Regarding claim 10, modified Markowitz teaches the method of claim 6, wherein Markowitz further teaches comparing the one or more signal features to identify the cardiac region includes determining whether the respective one or more of the locations of the one or more first electrodes corresponds to a valve of the patient's heart (fig. 26A and fig. 28 the catheter may be used to identify the anatomy such as the tricuspid valve [0298]).
Regarding claim 11, modified Markowitz teaches the method of claim 1, wherein Markowitz further teaches wherein displaying the visual indicia includes modifying the visual indicia as the one or more first electrodes move from a first cardiac region to a second cardiac region, the first cardiac region different from the second cardiac region (fig. 26A and fig. 28 the catheter may be used to identify different sections of the anatomy as the catheter moves through the patient, the visual indicia may be modified to include more tags and/or geometric shapes [0298] and [0301]).
Regarding claim 15, modified Markowitz teaches the method of claim 1, wherein Markowitz further teaches wherein the visual indicia includes a tag (fig. 28 the display 58 includes a tag denoting the cardiac region [0306])
Regarding claim 16, modified Markowitz teaches the method of claim 1, wherein Markowitz further teaches wherein: the one or more signal features of the electrogram includes first and second signal features of the electrogram at different times (fig. 27 A large spike 581a1 and small spike 581a2[0301]), and the cardiac region is further identified based on comparing the first and second signal features of the electrogram ([0301] the region is identified to be the SVC or the RA based on the comparison).
Regarding claim 19, modified Markowitz teaches the method of claim 16, wherein Markowitz further teaches comparing the one or more signal features to identify the cardiac region includes comparing a first amplitude of the first signal feature of the electrogram to a second amplitude of the second signal feature of the electrogram ([0316] regarding the EGM voltage, if the voltage amplitudes decreases, the catheter may be in the SVC, but if the voltage amplitude increase than the catheter may be determined to be in the RA, therefore there must be a comparison between a first and second voltage amplitudes of the electrogram).
Regarding claim 79, modified Markowitz teaches the method of claim 1, wherein Markowitz further teaches wherein the one or more signal features of the electrophysiological signal corresponds to a P-wave in the physiological signal (fig. 27C P-wave 583c1 is used for the comparison [0303]).
Regarding claim 83, modified Markowitz teaches the method of claim 1, wherein Markowitz further teaches wherein the electrophysiological signal comprises an electrocardiogram measured by the second electrodes on an outer surface of the patient's body (fig. 26a the ECG electrodes 572a-c can measure the signals from outside the patient’s body [0300]), the signal features include deflections representing known signatures of cardiac electrical activity for respective regions of the heart, and the deflections in the electrocardiogram are compared to deflections in the electrogram to determine the identified cardiac region (fig. 27A spike 583A1 is indicative that the catheter is in the SVC or RA when compared with the EGM that also has a spike 581a1 at the time [0301]).
Regarding claim 84, modified Markowitz teaches the method of claim 1 wherein the one or more features of the electrogram includes one or more features representative of atrial electrical activity and/or ventricular electrical activity (fig. 29C the features of the electrogram are used to identify portions of the heart [0307], portions can include the right atrium and right ventricle), and the identified cardiac region is determined based on an amount of the atrial electrical activity relative to an amount of the ventricular electrical activity (fig. 29C block 606 and 634 include queries that determines if the catheter is in the right atrium or right ventricle and the EGM/ECGs are used for the determining [0321] and [0323]).
Regarding claim 85, modified Markowitz teaches the method of claim 1, wherein Markowitz further teaches wherein the identified cardiac region is a discrete cardiac region that includes one of an atrium (fig. 28 RA’ is the right atrium and has been identified [0306])
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Markowitz as modified by Nagata, Lu, and Massarwa as applied to claim 1, and further in view Grunwald et al., (US20110196248A1).
Regarding claim 5, modified Markowitz teaches the method of claim 1, wherein Markowitz teaches displaying the visual indicia includes a representation of the catheter on the graphical user interface (fig. 35 the display 58 illustrates a representation of the catheter [0378] but fails to explicitly disclose regarding wherein displaying the visual indicia includes changing a representation of the catheter on the graphical user interface based on the identified cardiac region responsive to a change in location from a cardiac region to another cardiac region different from the cardiac region
In the same catheter navigation field of endeavor, Grunwald teaches changing a representation of the catheter on the graphical user interface based on the identified cardiac region responsive to a change in location from a cardiac region to another cardiac region different from the cardiac region (figs. 24A-24F location icons 3120-3170 change depending on the catheter’s movement direction [0269]-[0275]. For example, if there is an arrow shape, then the catheter is moving towards the target [0270] or a dot, star, or cross means it is moving away from the heart [0275]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter representation system of modified Markowitz with the changing of the icon representing the catheter of Grunwald, as this would help optimize therapy and the effect of the therapy in real-time (see Grunwald [0002]). One of ordinary skill would understand that this application of the icon changing system of Grunwald to the user selected treatment region of modified Markowitz and result in the reading of the limitation changing a representation of the catheter on the graphical user interface based on the identified cardiac region responsive to a change in location from the selected treatment region to another cardiac region different from the selected treatment region.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Markowitz as modified by Nagata, Lu, and Massarwa as applied to claim 1, and further in view of Afonso (US20070208260A1).
Regarding claim 12, modified Markowitz teaches the method of claim 1, wherein Markowitz further teaches wherein, based on the identified cardiac region corresponding to a valve of the patient's heart, displaying the visual indicia based on the identified cardiac region (fig. 28 display 58 has the identified cardiac regions that have shapes used to surround the points that correspond to the cardiac regions such as the tricuspid or pulmonic valve [0306]).
However Markowitz is silent regarding displaying a contour along a portion of the representation of the patient’s heart on the graphical user interface.
In the same electrophysiological field of endeavor, Afonso teaches displaying a contour along a portion of the representation of the patient’s heart on the graphical user interface ([0014] maps may be presented by utilizing contour lines such as isochrones).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the visuals of the valve of the method of Markowitz to use the contours of Afonso, as this would help the user to identify potential problem areas (see Afonso [0056]).
Claim 14 are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz as modified by Nagata, Lu, and Massarwa as applied to claim 1, and further in view of Hauck et al., (US20190269368A1), (hereinafter “Hauck”).
Regarding claim 14, modified Markowitz teaches the method of claim 1, but fails to explicitly disclose wherein the selected treatment region is a location of the heart and displaying the indication includes displaying whether the identified cardiac region corresponds to a location of the heart.
However in the same catheter field of endeavor, Hauck teaches the selected treatment region is an atrium ([0015] user inputs two identified target sites that defines a path defined by the input of the user, [0102] target sites for cardiac arrhythmia [0083] target of treatment is atrial fibrillation) and displaying the indication includes displaying whether the identified cardiac region corresponds to an atrium ([0102] the identified treatment sites are superimposed on the 3-d model of the heart, and potential treatment sites flagged on the display, the display would show if the selected treatment site corresponds to a location of the heart [0083] treatment is atrial fibrillation).
It would have been obvious to one of ordinary skill in the art at the time substitute the treatment region of modified Markowitz of claim 13, with the atrial location of Hauck, as both inventions relate to placing electrodes on catheters within the heart, and would yield predictable results to one of ordinary skill. One of ordinary skill would be able to make such a substitution, and the results of the method of modified Markowitz targeting the atrium are reasonable predictable.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Markowitz as modified by Nagata, Lu, and Massarwa as applied to claim 16, and further in view of Armoundas (US20150272464A1) (hereinafter “Armoundas”).
Regarding claim 17, modified Markowitz teaches the method of claim 16, but is silent regarding processing the electrogram, wherein processing the electrogram includes band-pass filtering the electrogram.
In the same electrogram field of endeavor, Armoundas teaches processing the electrogram, wherein processing the electrogram includes band-pass filtering the electrogram ([0077] The intracardiac electrograms are bandpass filtered)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the method of modified Markowitz with the bandpass filtering of Armoundas, as both inventions relate to intracardiac electrograms, and would yield predictable results to one of ordinary skill in the art. One of ordinary skill in the art would be able to perform such a combination, and the results of modified Markowitz using a bandpass filter are reasonably predictable, as it would cut down on the number of extraneous signals processed.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Markowitz as modified by Nagata and Massarwa applied to claim 19, and further in view of Cox et al., (US20110015533A1).
Regarding claim 20, modified Markowitz teaches the method of claim 19, but fails to explicitly disclose wherein the first amplitude of the first signal feature of the electrogram corresponds to timing of a P-wave in the electrophysiological signal, and the second amplitude of the second signal feature of the electrogram corresponds to timing of a QRS complex in the electrophysiological signal.
In the same catheter field of endeavor, Cox teaches wherein the first amplitude of the first signal feature of the electrogram corresponds to timing of a P-wave in the physiological signal and the second amplitude of the second signal feature of the electrogram corresponds to timing of a QRS complex in the physiological signal ([0231] fig. 59 shows a waveform with a timing of a #1052 p-wave and then a timing of a #1096 QRS complex, the magnitude of the peaks is then compared as a ratio).
It would have been obvious to one of ordinary skill in the art at the time to modify the method of modified Markowitz with the ratio of the magnitude of the peaks of the P-wave and QRS complex of Cox, as this would assist the clinician in determining the change of the ECG eave form as the catheter is advanced through the vasculature (see Cox [0231]).
Claim 77 is rejected under 35 U.S.C. 103 as being unpatentable over Markowitz as modified by Nagata, Lu, and Massarwa as applied to claim 19, and further in view of Rice et al., (US20210022623A1).
Regarding claim 77, modified Markowitz teaches the method of claim 19, wherein Markowitz teaches comparing the one or more signal features the cardiac region ([0306] the cardiac region is identified by comparing the features of the ECG and EGM) but is silent regarding comparing the ratio of the first amplitude to the second amplitude.
However, in the same ECG field of endeavor, Rice teaches comparing the ratio of the first amplitude to the second amplitude ([0049] an ECG sensor may be used to determine physiological parameters, and comparisons can be made between the ratio of amplitudes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the identifying of cardiac regions of modified Markowitz with the comparison of ratio of amplitudes as taught by Rice, as this would help to improve in/outpatient healthcare by opening up new directions for personal health and fitness (see Rice [0003]).
Claim 78 is rejected under 35 U.S.C. 103 as being unpatentable over Markowitz as modified by Nagata, Lu, and Massarwa as applied to claim 77, and further in view of Babkin et al., (US20190125422A1).
Regarding claim 78, modified Markowitz teaches the method of claim 77, where Markowitz teaches comparing the one or more signal features to identify the cardiac region ([0306] the cardiac region is identified by comparing the features of the ECG and EGM) but is silent regarding comparing the ratio to one or predetermined thresholds.
In the same electrical activity monitoring field of endeavor, Babkin teaches comparing the ratio to one or predetermined thresholds ([0092] the electrogram amplitudes ratio is compared until it is at a ratio of 1:2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Markowitz with the comparisons of Babkin, as this would assist the surgeon in determining positional information (See Babkin [0093]).
Claim 81 is rejected under 35 U.S.C. 103 as being unpatentable over Markowitz in view of Nagata and in further view of Lu and Grunwald.
Regarding claim 81, the embodiment of fig. 28 of Markowitz teaches a method, comprising: receiving an electrogram measured by one or more first electrodes of a catheter positioned at locations within a patient's heart (fig. 26A an mapping catheter 100 may have electrodes to measure electrograms from within the heart [0300]);
receiving an physiological signal corresponding to one or more second electrodes at respective substantially fixed locations relative to the patient's heart (fig. 26 electrodes 572 a-c are used for an electrocardiogram and are at fixed locations relative to the heart [0299]),
determining one or more signal features of the electrophysiological signal, in which each signal feature is indicative of cardiac electrical activity associated with a respective cardiac region ([0299] different features of the cardiac electrical cycle can be identified such as P-wave, R-wave, T-wave, and would be associated with a cardiac region; [0301] the P-wave indicates that the electrode of the catheter is in the superior vena cava (SVC) or right atrium (RA));
identifying a cardiac region representing a current location of the one or more first electrodes within the patient's heart ([0301] “When the spike 581 a 1 of the EGM 580 a occurs coincident in time or before the P-Wave spike 583 a 1 of the ECG 582 a, it is an indication that the electrode measuring the EGM is in the SVC or RA”; the spike would represent the electrode’s current location at the time of the spike) based on analyzing one or more signal features of the electrogram that temporally align with the one or more respective signal features of the physiological signal (fig. 27A-D the timings of the ECG and electrogram are compared [0301]); and
displaying, based at least in part on the identified cardiac region, visual indicia on a graphical user interface based on the identified cardiac region (fig. 28 display 58 displays shapes that are used to illustrate the sections of the heart that have been identified [0306]).
However, Markowitz is silent regarding wherein coloring at least a portion of a representation of the patient’s heart based on the identified cardiac region.
In the same electrophysiological field of endeavor, Nagata teaches coloring at least a portion of a representation of the patient’s heart based on the identified cardiac region ([0122] when the identified value of the right ventricle is an abnormal value for the right ventricle, the right ventricle portion flashes red).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the representation of the catheter that is capable of changing colors of Markowitz with the
However, the combination of references are silent regarding on a graphical user interface, displaying visual indicia, indicative of the respective current location of the one or more first electrodes.
In the same electrophysiological field of endeavor, Lu teaches a graphical user interface (fig. 1a display 27 [0005]), displaying visual indicia, indicative of the respective current location of the one or more first electrodes ([0005] the display 27 is used to display visual indicia to track the real-time current location of the electrode catheter in the heart).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Markowitz with the display of Lu, as this would result in a simulated output that more accurately corresponds to what would be experienced by a health care professional when mapping or performing a procedure on a patient (see Lu [0047]).
However, the combination of references are silent regarding changing a representation of the catheter on the graphical user interface based on the identified cardiac region responsive to a change in the current location from one discrete cardiac region to another discrete cardiac region different from the cardiac region
In the same catheter navigation field of endeavor, Grunwald teaches changing a representation of the catheter on the graphical user interface based on the identified cardiac region responsive to a change in the current location from one discrete cardiac region to another discrete cardiac region different from the cardiac region (figs. 24A-24F location icons 3120-3170 change depending on the catheter’s movement direction, and dots can represent the identified location such as the SVC, caval-atrial junction, right atrium, etc., [0269]-[0275]. For example, if there is an arrow shape, then the catheter is moving towards the target [0270] or a dot, star, or cross means it is moving away from the heart [0275]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter representation system of modified Markowitz with the changing of the icon representing the catheter of Grunwald, as this would help optimize therapy and the effect of the therapy in real-time (see Grunwald [0002]). One of ordinary skill would understand that this application of the icon changing system of Grunwald to the user selected treatment region of modified Markowitz and result in the reading of the limitation changing a representation of a catheter on the graphical user interface based at least in part on the identified cardiac region indicating a change in the current location from one discrete cardiac region to another discrete cardiac region different from the identified cardiac region.
Claim 82 is rejected under 35 U.S.C. 103 as being unpatentable over Markowitz in view of Armoundas, Nagata, and Ghosh et al., (US20150032173A1), Lu and Rothenberg (US20130123597A1).
Regarding claim 82, Markowitz teaches a method, comprising: receiving an electrogram measured by one or more first electrodes of a catheter positioned at locations within a patient's heart (fig. 26A an mapping catheter 100 may have electrodes to measure electrograms from within the heart [0300]);
receiving a physiological signal corresponding to one or more second electrodes a respective substantially fixed locations relative to the patient’s heart (fig. 26 electrodes 572 a-c are used for an electrocardiogram and are at fixed locations relative to the heart [0299]),
determining one or more signal features of the electrophysiological signal, in which each signal feature is indicative of cardiac electrical activity associated with a respective cardiac region ([0299] different features of the cardiac electrical cycle can be identified such as P-wave, R-wave, T-wave, and would be associated with a cardiac region; [0301] The P-wave indicates that the catheter is in the SVC or RA);
identifying a cardiac region representing a current location of the one or more first electrodes within the patient's heart ([0301] “When the spike 581 a 1 of the EGM 580 a occurs coincident in time or before the P-Wave spike 583 a 1 of the ECG 582 a, it is an indication that the electrode measuring the EGM is in the SVC or RA”; the spike would represent the current location of the electrode at the time of the spike) based on analyzing one or more signal features of the electrogram that temporally align with the one or more respective signal features of the physiological signal (fig. 27A-D the timings of the ECG and electrogram are compared [0301]); on a graphical user interface (fig. 28 the map points on the display may be illustrated in different colors [0306]), displaying visual indicia based on the identified cardiac region (fig. 28 there are shapes that are used to illustrate the sections of the heart [0306]),
displaying, based at least in part on the identified cardiac region, the visual indicia on a graphical user interface (fig. 28 the shapes are for portions of the heart that have been identified[0306]).
However, Markowitz are silent regarding bandpass filtering the electrogram.
In the same electrogram field of endeavor, Armoundas teaches bandpass filtering the electrogram([0077] The intracardiac electrograms are bandpass filtered).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the filtering of modified Markowitz with the bandpass filtering of Armoundas, as both inventions relate to intracardiac electrograms, and would yield predictable results to one of ordinary skill in the art. One of ordinary skill in the art would be able to perform such a substitution, and the results of modified Markowitz using a bandpass filter are reasonably predictable, as it would cut down on the number of extraneous signals processed.
However the combination of references fail to explicitly disclose modifying one or more user interface options displayed on the graphic user interface.
In the same GUI in the medicine field of endeavor, Ghosh teaches modifying one or more user interface options displayed on the graphic user interface (fig. 1 a user may provide input to the input apparatus 142 to manipulate, or modify, one or more graphical depictions displayed on the display apparatus 130 to view and/or select one or more target or candidate locations of a portion of a patient's heart [0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the GUI of modified Markowitz with the input apparatus of Ghosh, as this both inventions relate to medical systems with display devices, and would yield the predictable result of modifying a user interface option on the GUI to one of ordinary skill in the art. One of ordinary skill would be able to perform such a combination, and the results of modified Markowitz with a GUI where the user interface options are modified are reasonably predictable.
However, the combination of references is silent regarding changing a representation on the graphical user interface based on the identified cardiac region.
In the same electrophysiological field of endeavor, Nagata teaches changing a representation on the graphical user interface based on the identified cardiac region ([0122] when right ventricle is an abnormal value, the right ventricle portion flashes red).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the shapes of Markowitz with the coloring of Nagata, as this would help users intuitively understand which portion of the heart relates to the identified values (see Nagata [0123]). This modification would result in the teaching of modifying one or more user interface options displayed on the graphical user interface based at least in part on the identified cardiac region.
However, the combination of references are silent regarding on a graphical user interface, displaying visual indicia, indicative of the respective current location of the one or more first electrodes.
In the same electrophysiological field of endeavor, Lu teaches a graphical user interface (fig. 1a display 27 [0005]), displaying visual indicia, indicative of the respective current location of the one or more first electrodes ([0005] the display 27 is used to display visual indicia to track the real-time current location of the electrode catheter in the heart).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Markowitz with the display of Lu, as this would result in a simulated output that more accurately corresponds to what would be experienced by a health care professional when mapping or performing a procedure on a patient (see Lu [0047]).
However the combination of references are silent regarding wherein the identified cardiac region comprise one of an atrium, and wherein displayed on the graphical user interface based at least in part on the identified cardiac region to indicate a change in the current location from one cardiac region to another cardiac region.
In the same catheter tracking field of endeavor, Rothenberg teaches wherein the identified cardiac region comprise one of an atrium ([0017] Based on the ECG, the identified cardiac region that the catheter is located at is the right atrium), and wherein displayed on the graphical user interface based at least in part on the identified cardiac region to indicate a change in the current location from one cardiac region to another cardiac region ([0175] the screen may display “ADVANCE”, “HOLD”, OR “WITHDRAW” as appropriate depending on where the catheter is.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Markowitz with the locations and display of Rothenberg, as this would expose patients to few risks and/or are less cumbersome than the x-ray method for working in the atrium (see Rothenberg [0030]).
Response to Arguments
Applicant's arguments filed 07/15/2025 regarding claim 1 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. Hauk has not been used to teach the amended limitations, and instead Massarwa has been used.
Applicant's arguments filed 07/15/2025 regarding claim 5 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. Fuimaono has not been used to teach the amended limitations, and instead Grunwald has been used.
Applicant's arguments filed 07/15/2025 regarding claim 81 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. Fuimaono has not been used to teach the amended limitations, and instead Grunwald has been used.
Applicant's arguments filed 07/15/2025 regarding claim 82 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. Fuimaono has not been used to teach the amended limitations, and instead Rothenberg has been used.
The remaining claims are rejected for substantially the same reasons listed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL Y FANG whose telephone number is (571)272-0952. The examiner can normally be reached Mon - Friday 9:30 am - 6:00pm.
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/MICHAEL YIMING FANG/ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798