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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/21/2024 and 05/15/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 10 and 11 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.
Claim 10 recites, “wherein the first set of leads in a single lead among the multiple leads.” The claim language fails to provide a limitation that is definitive. Examiner wonders if the claim limitation should read:
“Wherein the first set of leads [[in]]is a single lead among the multiple leads.” or if a portion of the limitation is missing. For compact prosecution reasons, Examiner considers claim 10 as reciting the proposed claim. If the assumption is incorrect, claim 10 will be properly considered after an amendment to clarify the intention of the limitation is made.
Claim 11 recites, “further comprising configuring the radar chart such that the period of time for each of the sectors based on a selection” The claim language fails to provide a limitation that is definitive. Examiner wonders if the claim limitation should read:
“Further comprising configuring the radar chart such that the period of time for each of the sectors is based on a selection.” For compact prosecution reasons, Examiner considers claim 11 as reciting the proposed claim. If the assumption is incorrect, claim 11 will be properly considered after an amendment to clarify the intention of the limitation is made.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 rejected under 35 U.S.C. 102(a)(1) as being anticipated by XUE (2011/0125042 A1).
RE claim 1, Xue teaches a system/method for presenting physiological data in a component ring. Xue teaches a method for presenting cardiac information originating from multiple leads connected to a patient, the method comprising:
(a)
receiving the cardiac information collected via the multiple leads;
Fig. 5, the display system (100) includes a plurality of sensors (102) attached to a patient (104) [0032]. The sensors (102) may be constructed in an assembly such as a sensor array (106) for attachment to the patient (104). The sensor array (106) may be configured to properly place the electrodes (102) in the proper orientation in placement across the patient (104) in order to obtain the desired leads of ECG data. These leads of ECG data may be precordial leads or frontal leads, or any other combination of ECG leads thereof (said cardiac information collected via the multiple leads) [0032].
(b)
detecting a segment within the cardiac information;
With reference to Fig. 4, the data displayed can be the data that is current [0029] or stored historical ECG data [0029].
(c)
creating a radar chart divided into sectors; and
Fig. 1, depicts frontal ECG component ring (10) and precordial ECG component ring (12) that are developed for two different planes though the body of a patient [0014]. Both ECG component rings (10, 12) include four component rings (said divided into sectors): Twave (14), ST segment (16), QRS wave (18), and P wave (20) [0014].
(d)
plotting data points on the radar chart that correspond to the cardiac information for first and second sets of leads within the multiple leads,
The frontal ECG component ring (10) includes indications of the relative direction of each of the six predominantly front ECG leads [0015]. These front leads include leads I, II, III, AVF, AVL, and AVR (said first set of leads within the multiple leads) [0015]. Fig. 2 shows the frontal ECG component ring (10) that displays the magnitudes of the morphology features in each of the six frontal leads (said plotting data points) [0020-0021]. Precordial ECG component ring (12) includes ten leads commonly associated with precordial ECG measurement, i.e., V1-V9, V4R (said second set of leads within the multiple leads) [0016]. Fig. 3 shows the precordial ECG component rings (12) that represent the electrical potentials acquired through a horizontal or precordial plane through the patient (said plotting data points) [0026].
(e)
wherein the data points corresponding to the first set of leads are shown differently than the data points corresponding to the second set of leads so as to be visually distinguishable from each other.
Fig. 2 shows the frontal ECG component ring (10) that displays the magnitudes of the morphology features in each of the six frontal leads [0020]. Each of the component rings (14-18) embody space defined by an inner edge (222) and an outer edge (24) with a center point (23) [0020]. A plurality of vectors are depicted in relation to the inner edges (22). This plurality of vectors indicate the absolute values of the amplitudes of each of the frontal ECG leads [0021]. The polarity of each of the morphology feature magnitudes may be indicated in a variety of ways, such as color/shading with solid arrows being positive and outlined arrows being negative [0021]. The frontal ECG component ring (10) further uses the direction of the vector extending from each of the inner edges (22) to indicate the morphology feature polarity (said plotting data points) [0021]. Fig. 3 shows the precordial ECG component rings (12) that represent the electrical potentials acquired through a horizontal or precordial plane through the patient [0026]. The graph of Fig. 3 shows the amplitudes of the extracted morphology features in each of the associated component rings (14-18) (said plotting data points) [0026]. Thus, comparing Figs. 2 and 3, it is clear that the data is displayed differently and therefore can distinguish the frontal ECG data from precordial ECG data (said visually distinguishable from each other).
RE claim 2, Xue teaches wherein each of the sectors corresponds to a different one of the multiple leads.
Fig. 1, depicts frontal ECG component ring (10) and precordial ECG component ring (12) that are developed for two different planes though the body of a patient [0014]. Both ECG component rings (10, 12) include four component rings (said sectors): Twave (14), ST segment (16), QRS wave (18), and P wave (20) (said correspond to different leads) [0014].
RE claim 3, Xu teaches wherein the first set of leads is associated with a first region of a heart and the second set of leads is associated with a second region of the heart.
Fig. 5, the display system (100) includes a plurality of sensors (102) attached to a patient (104) [0032]. The sensors (102) may be constructed in an assembly such as a sensor array (106) for attachment to the patient (104). The sensor array (106) may be configured to properly place the electrodes (102) in the proper orientation in placement across the patient (104) in order to obtain the desired leads of ECG data. These leads of ECG data may be precordial leads (said first set of leads associated with a first region of a heart) or frontal leads (said second set of leads associated with a second region of a heart), or any other combination of ECG leads thereof [0032].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 8-12, 15 are rejected under 35 U.S.C. 103 as being unpatentable over TAHA (2009/0141593 A1) in view of Meek et al. (“ABC of clinical electrocardiography”).
RE claim 1, Taha teaches displaying temporal and/or complex data on a display of a small portable device [0018]. Taha teaches a method for presenting cardiac information originating from multiple leads connected to a patient, the method comprising:
(a)
receiving the cardiac information collected via the multiple leads;
Fig. 1, the system (10) may be configured to facilitate acquisition of patient data from the patient (12) via one or more medical devices [0020]. Patient data may be acquired by monitoring devices (14, 16) via one or more sensors that may be disposed on the patient (12) [0024]. The sensors include ECG sensor, where the sensors may be operationally coupled to a data acquisition device (18), via leads [0024]. Fig. 2, flow chart (40) includes step (42) where the device (28) is configured to obtain temporal patient data representative of one or more patient parameters [0031].
(b)
detecting a segment within the cardiac information;
Taha teaches selecting a 12-hour time period of temporal patient data [0033, 0041]. Taha further teaches a snapshot of the ECG signal having a predetermined time period may be considered, such as a 10-second snapshot of the ECG signal about each minute of the hour may be obtained [0058].
(c)
creating a radar chart divided into sectors; and
Data processing platform (34) may include a clock plot generating module (36) [0028]. The temporal patient data may be converted to a corresponding data set in clock coordinates, where the data has been plotted on a dial of a clock. More particularly, the data set in clock coordinates may include a radial component r and an angular component ϴ, where the angular component ϴ may be representative of hour markings on a clock dial (said divided into sectors) [0031]. Each hour marking on the clock dial may be separated by about 30 degrees [0037].
(d)
plotting data points on the radar chart that correspond to the cardiac information for first and second sets of leads within the multiple leads,
The temporal patient data may be presented as a clock plot mimicking a dial of a clock [0032]. Each hour corresponds to the temporal patient data that is correlated to a corresponding hour on the clock dial [0032]. Taha teaches selecting a 12-hour time period of temporal patient data, and converting the data to a corresponding clock coordinates [0033]. Fig. 3, the clock plot may be generated such that the radial component of the clock data set may be plotted along a corresponding hour (radial line) of the clock dial [0039]. Taha further teaches plotting complex data such as signals obtained via a multi-lead ECG (i.e., 12-lead ECG) (said multiple leads) [0057]. Fig. 7, once the amplitude values (108) at each second of the 10-second snapshot of the ECG signal (106) are obtained, these symbols (108) may be presented on a clock dial [0059]. The symbols (108) maybe color coded and represented on the radial line (124) [0059].
Taha teaches a 12-lead ECG data but fails to disclose the multiple leads as first and second sets. Meek is made of record as teaching the arrangement of the leads in regards to anatomical relationships. Leads II, III, and VF view the inferior surface of the heart (said first set); leads V1-V4 view the anterior surface (said second set); leads I, AVL, V5, and V6 view the lateral surface (said set); and leads V1 and aVR look through the right atrium directly into the cavity of the left ventricle (said set) [0009].
It would have been obvious before the effective filing date of the claimed invention that the leads of Taha correlate to the certain areas of the heart as taught by Meek. From the teachings of Meek, this is standard procedure.
(e)
wherein the data points corresponding to the first set of leads are shown differently than the data points corresponding to the second set of leads so as to be visually distinguishable from each other.
Taha further teaches once the amplitude values (108) at each second of the 10-second snapshot of the ECG signal (106) are obtained, these symbols (108) may be presented on a clock dial [0059, Fig. 7]. The symbols (108) maybe color coded and represented on the radial line (124) [0059]. Therefore, the data of the multi-lead ECG can be distinguishable from each other based on the symbol and/or color-coding.
RE claim 8, Taha in view of Meek teaches further comprising
(a)
plotting the data points on the radar chart that correspond to the cardiac information for a third set of leads within the multiple leads,
As taught in the rationale of claim1(d), Taha teaches plotting complex data such as signals obtained via a multi-lead ECG (i.e., 12-lead ECG) (said multiple leads) [0057]. Fig. 7, once the amplitude values (108) at each second of the 10-second snapshot of the ECG signal (106) are obtained, these symbols (108) may be presented on a clock dial [0059]. The symbols (108) maybe color coded and represented on the radial line (124) [0059]. Meek is made of record as teaching the arrangement of the leads in regards to anatomical relationships. Leads II, III, and VF view the inferior surface of the heart (said first set); leads V1-V4 view the anterior surface (said second set); leads I, AVL, V5, and V6 view the lateral surface (said third set); and leads V1 and aVR look through the right atrium directly into the cavity of the left ventricle (said set) [0009].
Therefore, Taha in view of Meek teaches plotting multi-lead ECG, where the ECG data of Taha is grouped based on the arrangement of leads in regards to anatomical relationships (said first, second, third set). The same motivation to combine as taught in the rationale of claim 1 is incorporated herein.
(b)
wherein the data points corresponding to the third set of leads are shown differently than the data points corresponding to the first and second sets of leads so as to be visually distinguishable therefrom,
Taha further teaches once the amplitude values (108) at each second of the 10-second snapshot of the ECG signal (106) are obtained, these symbols (108) may be presented on a clock dial [0059, Fig. 7]. The symbols (108) maybe color coded and represented on the radial line (124) [0059]. Therefore, the data of the multi-lead ECG can be distinguishable from each other based on the symbol and/or color-coding.
(c)
further comprising connecting the data points that are adjacent to each other within each of the first set of leads, the second set of leads, and the third set of leads, respectively, to form three overlapping shapes, respectively, wherein each of the three overlapping shapes has a different color.
As shown in the example of the clock plot of Fig. 4, the clock plot of Taha connects the values at each “hour”, i.e., radial line, resulting in overlapping shapes [0045-0047].
RE claim 9, Taha teaches wherein
(a)
the sectors each correspond to a period of time and
Data processing platform (34) may include a clock plot generating module (36) [0028]. The temporal patient data may be converted to a corresponding data set in clock coordinates, where the data has been plotted on a dial of a clock. More particularly, the data set in clock coordinates may include a radial component r and an angular component ϴ, where the angular component ϴ may be representative of hour markings on a clock dial (said sectors) [0031]. Each hour marking on the clock dial may be separated by about 30 degrees (said sectors correspond to a period of time) [0037].
(b)
the data points are plotted for the first and second sets of leads as a function of the period of time in which each was collected.
The temporal patient data may be presented as a clock plot mimicking a dial of a clock [0032]. Each hour corresponds to the temporal patient data that is correlated to a corresponding hour on the clock dial [0032]. Taha teaches selecting a 12-hour time period of temporal patient data, and converting the data to a corresponding clock coordinates [0033]. Fig. 3, the clock plot may be generated such that the radial component of the clock data set may be plotted along a corresponding hour (radial line) of the clock dial [0039]. Taha further teaches plotting complex data such as signals obtained via a multi-lead ECG (i.e., 12-lead ECG) (said multiple leads) [0057]. Fig. 7, once the amplitude values (108) at each second of the 10-second snapshot of the ECG signal (106) are obtained, these symbols (108) may be presented on a clock dial [0059]. The symbols (108) maybe color coded and represented on the radial line (124) [0059].
As taught by Meek, Meek teaches Taha’s 12-lead ECG is known to be grouped according to anatomical relationships, i.e. the inferior surface of the heart (said first set); the anterior surface (said second set); the lateral surface (said set); and those that look through the right atrium directly into the cavity of the left ventricle (said set) [0009]. The same motivation to combine as taught in the rationale of claim 1 is incorporated herein.
RE claim 10, please note the §112(b) rejection. Therefore, claim 10 is examined assuming the claim should recite the following limitation. Taha teaches wherein the first set of leads is a single lead among the multiple leads.
Fig. 5 of Taha displays the GUI (80) of the invention. The clinician may select one or more patient parameters and view a corresponding data set on the clock dial (62) [0050]. The parameters may be provided in a drop down menu, thereby allowing the clinician a wider choice of patient parameters to select from [0050]. Furthermore, Taha teaches obtaining a 12-lead ECG of the patient [0057]. As taught by Meek, leads II, III, and VF view the inferior surface of the heart (said first set); leads V1-V4 view the anterior surface (said second set); leads I, AVL, V5, and V6 view the lateral surface (said set); and leads V1 and aVR look through the right atrium directly into the cavity of the left ventricle (said set) [0009].
It would have been obvious before the effective filing date of the claimed invention of Taha to select only desired leads of the ECG data to display because the GUI (80) of Taha permits displaying selected parameters on the clock plot [0050]. It would be beneficial to select only one of leads II, III, and VF (said single lead) in order to concentrate on one parameter when that reading seems to have complications. Therefore, the clinician is not distracted by the other variables being displayed. The same motivation to combine Taha in view of Meek as taught in the rationale of claim 1 is incorporated herein.
RE claim 11, please note the §112(b) rejection. Claim 11 is examined assuming the claim should recite the amended limitation within the rationale.
Taha teaches further comprising
(a)
configuring the radar chart such that the period of time for each of the sectors is based on a selection, and
Taha teaches the clinician may view patient data corresponding to a date that is different from a current date [0051]. The clinician may also select a desired time frame to view the clinical data via a time frame field (88) [0052].
(b)
further comprising subsequently updating the data points plotted on the radar chart based on the selection.
Once the desired date is selected, temporal patient data corresponding to the selected date may be acquired, and clock plots may be generated and displayed [0051]. Additionally, device (28) may then obtain temporal patient data corresponding to the selected time period. Clock plots corresponding to temporal patient data associated with the selected time frame may be generated and displayed [0052].
RE claim 12, Taha in view of Meek teaches wherein the radar chart corresponds to a first region of the heart, and wherein all of the data points plotted on the radar chart correspond to individual leads among the multiple leads associated with the first region.
Taha further teaches plotting complex data such as signals obtained via a multi-lead ECG (i.e., 12-lead ECG) (said multiple leads) [0057]. Taha further teaches the clinician may select one or more patient parameters and view a corresponding data set on the clock dial (62) [0050]. The parameters may be provided in a drop down menu, thereby allowing the clinician a wider choice of patient parameters to select from [0050]. As taught by Meek, leads II, III, and VF (said individual leads associated with the first region) view the inferior surface of the heart (said first region of the heart) [0009].
It would have been obvious before the effective filing date of the claimed invention of Taha to select desired leads of the ECG data to display because the GUI (80) of Taha permits displaying selected parameters on the clock plot [0050]. It would be beneficial to select only leads II, III, and VF in order to concentrate on a certain region of the heart when it is detected that region is having complications (said radar chart correspond to individual leads associated with first region). Therefore, the clinician is not distracted by the other variables being displayed. The same motivation to combine Taha in view of Meek as taught in the rationale of claim 1 is incorporated herein.
RE claim 15, Taha teaches further comprising
(a)
further comprising receiving one of at least a lead-based selection and a time-based selection,
Fig. 5 of Taha displays the GUI (80) of the invention. The clinician may select one or more patient parameters and view a corresponding data set on the clock dial (62) [0050]. The parameters may be provided in a drop down menu, thereby allowing the clinician a wider choice of patient parameters to select from (said receiving one of at least a lead-based selection) [0050]. Furthermore, Taha teaches obtaining a 12-lead ECG of the patient [0057]. Taha teaches the clinician may view patient data corresponding to a date that is different from a current date [0051]. The clinician may also select a desired time frame to view the clinical data via a time frame field (88) (said receiving one of at least a time-based selection) [0052]. This time frame may be and “AM” or “PM” period, but also a 12 hour period, such as 10am – 10pm can be selected [0032].
(b)
wherein receiving the lead-based selection causes the radar chart to be created such that each of the sectors corresponds to one of the multiple leads, and
Temporal patient data corresponding to the selected patient parameters may be obtained [0050]. Subsequently, clock plots corresponding to the selected parameters may be generated and displayed [0050]. Thus, the clinician of Taha can selected the desired leads of the 12-lead ECG data to display accordingly.
(c)
wherein receiving the time-based selection causes the radar chart to be created such that each of the sectors corresponds a period of time, and
The clinician may select either an “AM” time frame or a “PM” time frame [0052] but also a 12 hour period, such as 10am – 10pm can be selected [0032]. The X-coordinate of the temporal patient data, namely the time factor, may be easily associated with a corresponding hour marking on the dial of the clock [0038]. Each hour in the 12-hour time period corresponding to the temporal patient data may be correlated to an hour on a clock dial [0038].
(d)
further comprising subsequently updating the data points plotted on the radar chart based on which of the one of at least the lead-based selection and the time-based selection is received.
Once the desired date is selected, temporal patient data corresponding to the selected date may be acquired, and clock plots may be generated and displayed [0051]. Additionally, device (28) may then obtain temporal patient data corresponding to the selected time period. Clock plots corresponding to temporal patient data associated with the selected time frame may be generated and displayed [0052].
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over XUE (2011/0125042 A1) in view of Meek et al. (“ABC of clinical electrocardiography”).
RE claim 4, Xue in view of Meek teaches wherein
(a)
the first region and second region are distinct and are each one of an anterior region, an inferior region, and a lateral region, and
Xue teaches the frontal ECG component ring (10) includes indications of the relative direction of each of the six predominantly front ECG leads (said first region) [0015]. These front leads include leads I, II, III, AVF, AVL, and AVR (said first set of leads) [0015]. Fig. 2 shows the frontal ECG component ring (10) that displays the magnitudes of the morphology features in each of the six frontal leads (said first region) [0020-0021]. Precordial ECG component ring (12) includes ten leads commonly associated with precordial ECG measurement, i.e., V1-V9, V4R (said second set of leads) [0016]. Fig. 3 shows the precordial ECG component ring (12) that represent the electrical potentials acquired through a horizontal or precordial plane through the patient (said second region) [0026]. Xue does not discuss the arrangement of the leads in regards to anatomical relationships.
Meek is made of record as teaching the arrangement of the leads in regards to anatomical relationships. Leads II, III, and VF view the inferior surface of the heart; leads V1-V4 view the anterior surface; leads I, AVL, V5, and V6 view the lateral surface; and leads V1 and aVR look through the right atrium directly into the cavity of the left ventricle [0009].
It would have been obvious before the effective filing date of the claimed invention that the leads of Xue correlate to the certain areas of the heart as taught by Meek. From the teachings of Meek, this is standard procedure.
(c)
wherein the first and second sets of leads each include between three and four of the multiple leads.
Xue teaches the frontal ECG component ring (10) includes indications of the relative direction of each of the six predominantly front ECG leads [0015]. These front leads include leads I, II, III, AVF, AVL, and AVR (said first set of leads include 3-4 of the multiple leads) [0015]. Precordial ECG component ring (12) includes ten leads commonly associated with precordial ECG measurement, i.e., V1-V9, V4R (said second set of leads include 3-4 of the multiple leads) [0016].
Claims 5, 6, 14 are rejected under 35 U.S.C. 103 as being unpatentable over TAHA (2009/0141593 A1) in view of Meek et al. (“ABC of clinical electrocardiography”) as applied to claim 1, and in further view of EDT (“How-to Highlight or Color Rings in an Excel Radar Chart” https://web.archive.org/web/20180210210816/http://www.exceldashboardtemplates.com/how-to-highlight-rings-or-color-rings-in-an-excel-radar-chart/).
RE claim 5, Taha in view of Meek and in further view of EDT teaches wherein a first color of the data points for the first set of leads is different than a second color of the data points for the second set of leads.
Taha teaches plotting complex data such as signals obtained via a multi-lead ECG (i.e., 12-lead ECG) (said multiple leads) [0057]. Fig. 7, once the amplitude values (108) at each second of the 10-second snapshot of the ECG signal (106) are obtained, these symbols (108) may be presented on a clock dial [0059]. The symbols (108) maybe color coded and represented on the radial line (124) [0059].
As further taught by Meek, Meek is made of record as teaching the arrangement of the leads in regards to anatomical relationships. Leads II, III, and VF view the inferior surface of the heart (said first set); leads V1-V4 view the anterior surface (said second set); leads I, AVL, V5, and V6 view the lateral surface (said set); and leads V1 and aVR look through the right atrium directly into the cavity of the left ventricle (said set) [0009].
Taha in view of Meek fail to disclose coloring the different leads based on the anatomical relationship. EDT is made of record as teaching radar charts. EDT teaches modifying line colors of the data within the radar chart by using the “Format Data Series …” menu [0020]. The line color can be adjusted as shown in Figs. 12 and 13. Thus, EDT provides a means of customizing the data sets within a radar chart.
In the combined invention, it would have been obvious before the effective filing date of the claimed invention to customize the color of the data sets as taught by EDT with the display of Taha and Meek (said wherein a first color of the data points for the first set of leads is different than a second color of the data points for the second set of leads). The different groups of data based on anatomical relationships can be colored differently in order to easily show distinction to the user.
RE claim 6, in further view of EDT, Taha in view of Meek and EDT teaches wherein the first color is the same for all of the data points within the first set of leads.
As taught in the rationale of claim 5, EDT is made of record as teaching radar charts. EDT teaches modifying line colors of the data within the radar chart by using the “Format Data Series …” menu [0020]. The line color can be adjusted as shown in Figs. 12 and 13. Thus, EDT provides a means of customizing the data sets within a radar chart. The user can customize to how they see fit. Therefore, the user can select the same color for all of inferior surface of the heart, i.e., Leads II, III, and VF, in order to visually distinguish the leads are part of the inferior surface. This would be beneficial to the user for quick reference which looking at the clock plot of Taha in view of Meek. The same motivation to combine as taught in the rationale of claim 5 is incorporated herein.
RE claim 14, Taha in view of Meek and in further view of EDT teaches wherein a first color of the data points for the first set of leads is different than a second color of the data points for the second set of leads.
Taha teaches plotting complex data such as signals obtained via a multi-lead ECG (i.e., 12-lead ECG) (said multiple leads) [0057]. Fig. 7, once the amplitude values (108) at each second of the 10-second snapshot of the ECG signal (106) are obtained, these symbols (108) may be presented on a clock dial [0059]. The symbols (108) maybe color coded and represented on the radial line (124) [0059].
As further taught by Meek, Meek is made of record as teaching the arrangement of the leads in regards to anatomical relationships. Leads II, III, and VF view the inferior surface of the heart (said first set); leads V1-V4 view the anterior surface (said second set); leads I, AVL, V5, and V6 view the lateral surface (said set); and leads V1 and aVR look through the right atrium directly into the cavity of the left ventricle (said set) [0009].
Taha in view of Meek fail to disclose coloring the different leads based on the anatomical relationship. EDT is made of record as teaching radar charts. EDT teaches modifying line colors of the data within the radar chart by using the “Format Data Series …” menu [0020]. The line color can be adjusted as shown in Figs. 12 and 13. Thus, EDT provides a means of customizing the data sets within a radar chart.
In the combined invention, it would have been obvious before the effective filing date of the claimed invention to customize the color of the data sets as taught by EDT with the display of Taha and Meek (said wherein a first color of the data points for the first set of leads is different than a second color of the data points for the second set of leads). The different groups of data based on anatomical relationships can be colored differently in order to easily show distinction to the user.
Claims 7, 16 are rejected under 35 U.S.C. 103 as being unpatentable over XUE (2011/0125042 A1) in view of CARDINALE et al. (2013/0023780A1).
RE claim 7, Xue teaches the limitations of claim 7 with the exception of providing a visual indication when one of the data points exceeds a threshold. Cardinale is made of record as providing a bullseye chart filled with ECG data that is colored or shaded to indicate normal and abnormal segments [abstract].
Cardinale teaches a display system for ultrasound images and ECG lead traces [0017, Fig. 1, 0019]. The ECG analysis module combines the signals from the electrodes in various ways to form the desired lead signals. The processed ECG information is then displayed on an image display such as output device (38) [0019]. Fig. 9 displays the bullseye chart of the ECG values (said radar chart divided into sectors) [0028]. Abnormal values (said data points exceeds the one or more predetermined thresholds) are shown shaded [0028]. The values of specific leads can be shown on the ECG bullseye for specific disease conditions being diagnosed [0030]. Amplitudes above certain thresholds indicate certain situations (said data points exceeds the one or more predetermined thresholds) [0030]. An implementation of an ECG bullseye chart can be automated by a processor which fills in segments of the ECG bullseye with characters or colors from the ST elevations values given for each ECG lead in column (90) [0032]. For example, segments with normal ST elevation values can be colored green, segments with elevated ST values (e.g., greater than 1 mV) can be colored red (said comparing values of the data point to one more predetermined thresholds and automatically providing a visual indication when one of the data points exceeds the one or more predetermined thresholds), and segments with depressed ST values (e.g., less than -1 mV) can be colored blue [0032].
It would have been obvious before the effective filing date of the claimed invention to color the values of Xue with the color implementation of Cardinale because the different colors can provide the user a sense of problem areas and the data indicating those abnormalities [0032].
RE claim 16, Xue teaches a system/method for presenting physiological data in a component ring. Xue teaches a method for presenting cardiac information originating from multiple leads connected to a patient, the method comprising:
(a)
receiving the cardiac information collected via the multiple leads;
Fig. 5, the display system (100) includes a plurality of sensors (102) attached to a patient (104) [0032]. The sensors (102) may be constructed in an assembly such as a sensor array (106) for attachment to the patient (104). The sensor array (106) may be configured to properly place the electrodes (102) in the proper orientation in placement across the patient (104) in order to obtain the desired leads of ECG data. These leads of ECG data may be precordial leads or frontal leads, or any other combination of ECG leads thereof (said cardiac information collected via the multiple leads) [0032].
(b)
detecting a segment within the cardiac information;
With reference to Fig. 4, the data displayed can be the data that is current [0029] or stored historical ECG data [0029].
(c)
creating a radar chart divided into sectors, wherein each of the sectors corresponds to one of the multiple leads; and
Fig. 1, depicts frontal ECG component ring (10) and precordial ECG component ring (12) that are developed for two different planes though the body of a patient [0014]. Both ECG component rings (10, 12) include four component rings (said divided into sectors): Twave (14), ST segment (16), QRS wave (18), and P wave (20) (said wherein each of the sectors corresponds to one of the multiple leads) [0014].
(d)
plotting, within each of the corresponding sectors, a first group of data points corresponding to the cardiac information for at least three leads within the multiple leads;
The frontal ECG component ring (10) includes indications of the relative direction of each of the six predominantly front ECG leads [0015]. These front leads include leads I, II, III, AVF, AVL, and AVR (said first group of data points corresponding to at least three leads) [0015]. Fig. 2 shows the frontal ECG component ring (10) that displays the magnitudes of the morphology features in each of the six frontal leads (said plotting data points) [0020-0021].
(e)
plotting, within each of the corresponding sectors, a second group of data points corresponding to the cardiac information for the at least three leads within the multiple leads collected subsequently to the first group of data points,
Precordial ECG component ring (12) includes ten leads commonly associated with precordial ECG measurement, i.e., V1-V9, V4R (said second group of points corresponds to at least three leads subsequently to the first group) [0016]. Fig. 3 shows the precordial ECG component rings (12) that represent the electrical potentials acquired through a horizontal or precordial plane through the patient (said plotting data points) [0026].
(f)
wherein the first group of data points are shown differently than the second group of data points so as to be visually distinguishable from each other;
Fig. 2 shows the frontal ECG component ring (10) that displays the magnitudes of the morphology features in each of the six frontal leads [0020]. Each of the component rings (14-18) embody space defined by an inner edge (222) and an outer edge (24) with a center point (23) [0020]. A plurality of vectors are depicted in relation to the inner edges (22). This plurality of vectors indicate the absolute values of the amplitudes of each of the frontal ECG leads [0021]. The polarity of each of the morphology feature magnitudes may be indicated in a variety of ways, such as color/shading with solid arrows being positive and outlined arrows being negative [0021]. The frontal ECG component ring (10) further uses the direction of the vector extending from each of the inner edges (22) to indicate the morphology feature polarity (said plotting data points) [0021]. Fig. 3 shows the precordial ECG component rings (12) that represent the electrical potentials acquired through a horizontal or precordial plane through the patient [0026]. The graph of Fig. 3 shows the amplitudes of the extracted morphology features in each of the associated component rings (14-18) (said plotting data points) [0026]. Thus, comparing Figs. 2 and 3, it is clear that the data is displayed differently and therefore can distinguish the frontal ECG data from precordial ECG data (said visually distinguishable from each other).
(g)
determining differences between the second group of data points to the first group of data points for the multiple leads, and
Fig. 4, Xue teaches identifying differences between two precordial ECG component rings [0029].
Xue teaches the limitations of claim 16 with the exception of discussing a comparison to thresholds. Cardinale teaches a display system for ultrasound images and ECG lead traces [0017, Fig. 1, 0019]. The ECG analysis module combines the signals from the electrodes in various ways to form the desired lead signals. The processed ECG information is then displayed on an image display such as output device (38) [0019].
(h)
comparing the differences to a threshold; and
Cardinale teaches Fig. 9 displays the bullseye chart of the ECG values (said radar chart divided into sectors) [0028]. Abnormal values are shown shaded [0028]. The values of specific leads can be shown on the ECG bullseye for specific disease conditions being diagnosed [0030]. Amplitudes above certain thresholds indicate certain situations (said comparing to a threshold) [0030].
(i)
generating and transmitting an alert to an external device when at least one of the differences exceeds the threshold.
Xue teaches the ECG component ring quickly identifies and highlights those areas where the recently or currently acquired ECG data differs from the control historical, or previously acquired data [0031]. However, Xue is not explicit in discussing a comparison to a threshold.
Cardinale further teaches an implementation of an ECG bullseye chart can be automated by a processor which fills in segments of the ECG bullseye with characters or colors from the ST elevations values given for each ECG lead in column (90) [0032]. For example, segments with normal ST elevation values can be colored green, segments with elevated ST values (e.g., greater than 1 mV) can be colored red (said generating and transmitting an alert to an external device when at least one of the differences exceeds the threshold), and segments with depressed ST values (e.g., less than -1 mV) can be colored blue [0032].
It would have been obvious before the effective filing date of the claimed invention to utilize a threshold to determine when values are abnormal, as taught by Cardinale. By alerting the user, Xue teaches this promotes efficiency of ECG data review by the reviewing clinician as a large amount of numeral and graphical ECG data across a plurality of precordial leads is presented in a single graphical presentation, highlighting the areas of most interest to the reviewing clinician [0031].
Claim 13 rejected under 35 U.S.C. 103 as being unpatentable over TAHA (2009/0141593 A1) in view of Meek et al. (“ABC of clinical electrocardiography”) as applied to claim 1, and in further view of NELWAN et al. (2014/0039338 A1).
RE claim 13, Taha in view of Meek teaches displaying the ECG data based on a time frame but fails to discuss the clock plot as a continuous plot. Nelwan is made of record as transforming and displaying measured values of ST segment deviations obtained from a multi-lead ECG into polar ST Circle Display [abstract]. Fig. 1 depicts two multi-axis diagrams (6, 7) used to represent the ST lead values of a common 12-Lead ECG [0019]. As shown in Fig. 7, Nelwan show a patient monitoring device display the ST values and other vital signs of the patient [0038]. The patient monitoring device includes hardware configured to measure the ST segment deviations and transform the measured values to ST circle display values and/or overlay them with a model of the heart, and a display for receiving and displaying the ST Circle display values (said plotted continuously) [0038].
It would have been obvious before the effective filing date of the claimed invention to plot the data of Taha continuously around the clock as taught by Newman in order consistently highlight areas of change in order for an experienced clinician to readily notice the changes in the patient’s condition [0035].
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over XUE (2011/0125042 A1) in view of CARDINALE et al. (2013/0023780A1) as applied to claim 16, and in further view of EDT (“How-to Highlight or Color Rings in an Excel Radar Chart” https://web.archive.org/web/20180210210816/http://www.exceldashboardtemplates.com/how-to-highlight-rings-or-color-rings-in-an-excel-radar-chart/).
RE claim 17, Xue in view of Cardinale teaches the limitations of claim 17 with the exception of discussing the color hues of the data. EDT is made of record as teaching radar charts. EDT teaches modifying line colors of the data within the radar chart by using the “Format Data Series …” menu [0020]. The line color can be adjusted as shown in Figs. 12 and 13. Thus, EDT provides a means of customizing the data sets within a radar chart. The color can be selected by the user therefore, the second group of data points can be shown darker than the first set of data points.
In the combined invention, it would have been obvious before the effective filing date of the claimed invention to customize the color of the data sets as taught by EDT with the display of Xue and Cardinale. By modifying the different colors to coordinate with groups, the user can easily distinguish what data belongs to what grouping for quicker analysis.
RE claim 18, in further view of Xue, Xue teaches further comprising
(a)
plotting an additional group of data points corresponding to the cardiac information for the at least three leads,
Fig. 4, Xue depicts two precordial ECG component rings (50, 52) to facilitate serial ECG comparison [0029]. ECG component ring (50) presents stored historical ECG data, while ECG component ring (52) represents currently or recently collected ECG data [0029]. It would have been obvious before the effective filing date of the claimed invention that as time passes, new current ECG can be collected (said additional group of data points). Thus, ECG component ring (52) would be updated to reflect the most recent data (said plotting additional group of data points). As taught in the rejection of claim 16(d) and 16(e), Xue teaches at least 3 leads (said information for the at least three leads) [0015-0016].
(b)
wherein the first group of data points is removed from the radar chart, the second group of data points becomes the first group of data points, and the additional group of data points become the second group of data points.
Following the rationale of claim 18(a), when the current data is updated, the second most recent current data would then be considered historical data. Therefore, the second most recent current data can be displayed as ECG component ring (50) and the most current data would then become ECE component ring (52).
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over XUE (2011/0125042 A1) in view of Meek et al. (“ABC of clinical electrocardiography”) and NAGATA et al. (2005/0182333 A1).
RE claim 19, Xue teaches a system/method for presenting physiological data in a component ring. Xue teaches a method for presenting cardiac information originating from multiple leads connected to a patient, the method comprising:
(a)
receiving the cardiac information collected via the multiple leads, wherein the cardiac information comprises values collected from the multiple leads;
Fig. 5, the display system (100) includes a plurality of sensors (102) attached to a patient (104) [0032]. The sensors (102) may be constructed in an assembly such as a sensor array (106) for attachment to the patient (104). The sensor array (106) may be configured to properly place the electrodes (102) in the proper orientation in placement across the patient (104) in order to obtain the desired leads of ECG data. These leads of ECG data (said cardiac data) may be precordial leads or frontal leads, or any other combination of ECG leads thereof (said cardiac information collected via the multiple leads) [0032].
(b)
detecting a segment within the cardiac information;
With reference to Fig. 4, the data displayed can be the data that is current [0029] or stored historical ECG data [0029].
(c)
creating a visual representation of a heart and depicting the heart having multiple regions wherein each of the multiple leads is associated with one of the multiple regions of the heart;
Xue teaches the frontal ECG component ring (10) includes indications of the relative direction of each of the six predominantly front ECG leads [0015]. These front leads include leads I, II, III, AVF, AVL, and AVR (said multiple leads) [0015]. Fig. 2 shows the frontal ECG component ring (10) that displays the magnitudes of the morphology features in each of the six frontal leads [0020-0021]. Precordial ECG component ring (12) includes ten leads commonly associated with precordial ECG measurement, i.e., V1-V9, V4R (said multiple leads) [0016]. Fig. 3 shows the precordial ECG component ring (12) that represent the electrical potentials acquired through a horizontal or precordial plane through the patient (said region of heart) [0026]. Xue does not discuss the arrangement of the leads in regards to anatomical relationships.
Meek is made of record as teaching the arrangement of the leads in regards to anatomical relationships. Leads II, III, and VF view the inferior surface of the heart; leads V1-V4 view the anterior surface; leads I, AVL, V5, and V6 view the lateral surface; and leads V1 and aVR look through the right atrium directly into the cavity of the left ventricle [0009].
It would have been obvious before the effective filing date of the claimed invention that the leads of Xue correlate to the certain areas of the heart as taught by Meek. From the teachings of Meek, this is standard procedure.
Xue in view of Meek provide ECG data in relation to certain anatomical portions of the heart but fails to create a visual representation of a heart and depict the lead associated to the region. Nagata is made of record as teaching an ECG chart device and method [abstract]. The “chart data” corresponds to data used for displaying the identified values in a radar chart form [Figs. 5-6, 0061]. The CPU (10) runs 12-lead ECG on a patient [0063]. The CPU (10) extracts identified values from the ECG waveform [0063]. With reference to Fig. 9, ECG data are displayed on a screen with a heart image background that correlates the data to the location of the heart (said creating a visual representation of a heart wherein each lead is associated with regions of heart) [0119-0120].
It would have been obvious before the effective filing date of the claimed invention to display the ECG data with the heart background as taught by Nagata, with the display of Xue in view of Meek because it provides a quick means of understanding which data originates from which portion of the heart. This would be beneficial to quicken diagnosis of the patient.
(d)
presenting the values of the cardiac information for at least three leads within the multiple leads so as to be visually associated with each of the multiple regions corresponding thereto.
In view of Xue, the frontal ECG component ring (10) includes indications of the relative direction of each of the six predominantly front ECG leads [0015]. These front leads include leads I, II, III, AVF, AVL, and AVR (said at least three leads) [0015]. Fig. 2 shows the frontal ECG component ring (10) that displays the magnitudes of the morphology features in each of the six frontal leads (said presenting values) [0020-0021]. Precordial ECG component ring (12) includes ten leads commonly associated with precordial ECG measurement, i.e., V1-V9, V4R (said at least three leads) [0016]. Fig. 3 shows the precordial ECG component rings (12) that represent the electrical potentials acquired through a horizontal or precordial plane through the patient (said presenting values) [0026].
As modified by Nagata, with reference to Fig. 9, ECG data are displayed on a screen with a heart image background that correlates the data to the location of the heart (said associated with each of the multiple regions corresponding thereto) [0119-0120]. As can be seen in Fig. 9, at least 3 graphs are displayed.
RE claim 20, Xue in view of Meek and Nagata teach further comprising
(a)
depicting a first region within the multiple regions as a different color than a second region within the multiple regions, and
Xue teaches differentiating component rings from each other by using color or shading [Fig. 1, 0014].
(b)
further comprising comparing the values to one or more predetermined thresholds and automatically providing a visual indication when one of the values exceeds the one or more predetermined thresholds.
In further view of Nagata, Nagata teaches drawing the user’s attention to an abnormal value within the radar chart [0087, 0098]. When the value is abnormal, the first technique is to change the color of the radar chart corresponding to the abnormal value (said visual indication) [0087, 0098]. Although Nagata does not disclose “thresholds”, comparing values to a threshold is needed in order to determine when the data values are within normal range or when they fall out of normal range.
It would have been obvious before the effective filing date of the claimed invention to incorporate the color changing of the radar chart when there are abnormal values as taught by Nagata within the display of Xue because the user can easily recognize that there is an abnormal value because the color of the radar corresponding to the abnormal value is changed [0087, 0098].
Conclusion
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/MICHELLE L SAMS/
Primary Examiner, Art Unit 2611
28 December 2025