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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 7-8, and 10-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 19-20 of U.S. Patent No. 12,131,413. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-5, 7-8, and 10-20 in the current application are broader in all respects than claims 1-14 and 19-20 of U.S. Patent No. 12,131,413.
Specifically, it is well established that “Omission of element and its function in combination is obvious expedient if remaining elements perform same functions as before” In re KARLSON (CCPA) 136 USPQ 184 (1963). Claims 1-5, 7-8, and 10-20 in the current application are broader in all respects than claims 1-14 and 19-20 of US Patent No. 12,131,413.
Below is a table indicating the corresponding relationship between claims 1-5, 7-8, and 10-20 of the current application and claims 1-14 and 19-20 of US Patent No. 12,131,413.
Current Application
U.S. Patent: 12,131,413
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3
2
4
3
5
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12
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14
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To perform analysis required, claim 3 of the current application is compared to claim 2 of U.S. Patent No. 12,131,413.
Claim 3: Current Application
Claim 2: U.S. Patent No. 12,131,413
An apparatus comprising:
at least one processing device comprising a processor coupled to a memory;
the at least one processing device being configured:
to select physiologic data to be visualized, the selected physiologic data comprising a given set of one or more physiologic parameters collected from a given set of one or more subjects over a given period of time;
to determine a plot type for visualization of the selected physiologic data, the plot type being determined based at least in part on a repetitiveness of the selected physiologic data over a plurality of time segments in the given period of time;
to generate a visualization of the selected physiologic data utilizing the determined plot type; and
to output the generated visualization of the selected physiologic data via an interactive graphical user interface;
wherein determining the plot type for the visualization comprises selecting among two or more different coordinate systems for the plot type based at least in part on determining that the selected physiologic data has one or more threshold levels of repetitiveness over the plurality of time segments in the given period of time
wherein selecting the physiologic data to be visualized comprises selecting the given set of one or more subjects, the given set of one or more physiologic parameters, and the given period of time from a database of available physiologic data.
the database of available physiologic data comprises a plurality of entries, each entry being associated with a given subject identifier for a given one of a plurality of subjects, a given timestamp, and a plurality of physiologic parameters collected from the given subject at the given timestamp; and
selecting the physiologic data to be visualized from the database of available physiologic data comprises obtaining the given set of one or more physiologic parameters from a selected subset of entries from the database of available physiologic data, the selected subset of entries having subject identifiers for the given set of one or more subjects and timestamps within the given period of time.
An apparatus comprising:
at least one processing device comprising a processor coupled to a memory;
the at least one processing device being configured:
to select physiologic data to be visualized, the selected physiologic data comprising a given set of one or more physiologic parameters collected from a given set of one or more subjects over a given period of time;
to determine a plot type for visualization of the selected physiologic data, the plot type being determined based at least in part on a repetitiveness of the selected physiologic data over a plurality of time segments in the given period of time;
to generate a visualization of the selected physiologic data utilizing the determined plot type; and
to output the generated visualization of the selected physiologic data via an interactive graphical user interface;
wherein determining the plot type for the visualization comprises (i) selecting a polar coordinate plot type responsive to determining that the selected physiologic data has at least a threshold level of repetitiveness over the plurality of time segments in the given period of time and (ii) selecting a Cartesian coordinate plot type responsive to determining that the selected physiologic data does not have at least the threshold level of repetitiveness over the plurality of time segments in the given period of time.
wherein: selecting the physiologic data to be visualized comprises selecting the given set of one or more subjects, the given set of one or more physiologic parameters, and the given period of time from a database of available physiologic data;
the database of available physiologic data comprises a plurality of entries, each entry being associated with a given subject identifier for a given one of a plurality of subjects, a given timestamp, and a plurality of physiologic parameters collected from the given subject at the given timestamp; and
selecting the physiologic data to be visualized from the database of available physiologic data comprises obtaining the given set of one or more physiologic parameters from a selected subset of entries from the database of available physiologic data, the selected subset of entries having subject identifiers for the given set of one or more subjects and timestamps within the given period of time.
As seen in the analysis above, claim 3 of the current application is clearly broader than claim 2 of U.S. Patent No. 12,131,413. Therefore, claim 3 is properly subject to ODP rejection.
Similarly, ODP rejection can be shown for claims 1-2, 4-5, 7-8, and 10-20 of the current application, as limitations in claims 1-2, 4-5, 7-8, and 10-20 are similarly recited as the limitations in the conflicting claims 1-14 and 19-20 of U.S. Patent No. 12,131,413.
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.
Claim(s) 1-8, 10-12, 15, 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stewart et al. (US 2018/0296108, hereinafter Stewart).
Regarding claim 1, Stewart discloses an apparatus (cardiac mapping system 100 including a processing unit 120/200; figures 1 and 2; paragraphs [0064, 0075]) comprising:
at least one processing device comprising a processor coupled to a memory (processing unit 120/200 includes a processor 202 and memory 204; figures 1 and 2; paragraphs [0064, 0075]);
the at least one processing device being configured:
to select physiologic data to be visualized (processing unit 202 may generate an annotated waveform 206, an annotation histogram 208 and a cardiac map 210 with the data signals determined by acceptor 212 and extracted by a waveform generator 214; figures 1 and 2; paragraphs [0064, 0075-0078]), the selected physiologic data comprising a given set of one or more physiologic parameters collected from a given set of one or more subjects over a given period of time (the data signals determined by acceptor 212 and extracted by a waveform generator 214 include data such as EGM and cardiac electrical signal features, and the features may include at least one corresponding time; Figures 1-2 and 5A; paragraphs [0062, 0064, 0075, 0077, 0097]);
to determine a plot type for visualization of the selected physiologic data (different types of maps, annotations of waveforms and annotations of histograms may be chosen; figures 1-3; paragraphs [0063, 0086, 0089, 0096, 0133]), the plot type being determined based at least in part on a repetitiveness of the selected physiologic data over a plurality of time segments in the given period of time (different types of maps, annotations of waveforms and annotations of histograms may be chosen based on alignment to a cardiac or biological cycles (given period of time); figures 1-4; paragraphs [0063, 0086, 0089, 0096, 0100, 0102, 0133]);
to generate a visualization of the selected physiologic data utilizing the determined plot type (processing unit 202 may generate an annotated waveform 206, an annotation histogram 208 and a cardiac map 210; figures 1-3; paragraphs [0064, 0075-0078]); and
to output the generated visualization of the selected physiologic data via an interactive graphical user interface (a display 170 may feature an interactive graphical user interface 630 which presents cardiac map 650 and signal features 636-644, including beat metrics 636 and EGM waveforms which are mapped against the time axis; figures 1-2 and 68; paragraphs [0072, 0075, 0144-0146]);
wherein determining the plot type for the visualization comprises selecting among two or more different coordinate systems for the plot type (“ … sensed cardiac signals may include three-dimensional Cartesian coordinates, polar coordinates, and/or the like”; different types of maps, annotations of waveforms and annotations of histograms may be chosen based on alignment to a cardiac or biological cycles, including mapping the 3d signals which may be aligned to cartesian coordinates or polar coordinates; figures 1-3; paragraphs [0063, 0086, 0089, 0096, 0133]) based at least in part on determining that the selected physiologic data has one or more threshold levels of repetitiveness over the plurality of time segments in the given period of time (the signal baseline may be used to compare to incoming signals and identify signals deviating from the baseline for a given cycle and compare to selected criteria such as attitude to evaluate if there is a deviation and adjust the presentation of the presented map; figures 4; paragraphs [0100-0102, 0106-0108]).
Regarding claim 2, Stewart discloses the apparatus of claim 1, wherein selecting the physiologic data to be visualized comprises selecting the given set of one or more subjects (a signal baseline may be determined based on patient information and provide-a patient specific baseline; figures 1 and 4; paragraphs [0100]), the given set of one or more physiologic parameters, and the given period of time from a database of available physiologic data (the data signals determined by acceptor 212 and extracted by a waveform generator 214 include data such as EGM and cardiac electrical signal features, and the features may include at least one corresponding time; Figures 1-2 and 5A; paragraphs [0062, 0064, 0075, 0077, 0097]).
Regarding claim 3, Stewart discloses the apparatus of claim 2, wherein:
the database of available physiologic data comprises a plurality of entries (storage device 120 stores the data acquired by the various modules as well as the raw electrode data, the reconstructed physiologic information, etc.; figures 1; paragraphs [0072]), each entry being associated with a given subject identifier for a given one of a plurality of subjects (patient information may be used to provide patient specific baselines; figures 4; paragraphs [0100, 0102]), a given timestamp (the data stream 302 may be aligned by an asynchronous system clock; figure 3; paragraphs [0086]), and a plurality of physiologic parameters collected from the given subject at the given timestamp (the data signals includes EGM and cardiac electrical signal features which are recorded over time; Figures 1-2 and 5A; paragraphs [0062, 0064, 0075, 0077, 0097]); and
selecting the physiologic data to be visualized from the database of available physiologic data comprises obtaining the given set of one or more physiologic parameters from a selected subset of entries from the database of available physiologic data (processing unit 202 may generate an annotated waveform 206, an annotation histogram 208 and a cardiac map 210 with the data taken from memory 160/204; figures 1 and 2; paragraphs [0072, 0075-0078, 0083]), the selected subset of entries having subject identifiers for the given set of one or more subjects and timestamps within the given period of time (patient information may be used to provide patient specific baselines and the baselines may be determined in part by an asynchronous system clock and the patient specific information ; figures 3-4; paragraphs [0086, 0100, 0102]).
Regarding claim 4, Stewart discloses the apparatus of claim 1, wherein determining the plot type for visualization of the selected physiologic data comprises:
dividing the given period of time into the plurality of time segments (different types of maps, annotations of waveforms and annotations of histograms may be chosen based on alignment to a cardiac or biological cycles (given period of time); figures 1-4; paragraphs [0086, 0096, 0100, 0102, 0133]);
comparing data in at least a subset of a plurality of possible pairs of the plurality of time segments for repetitiveness (the signal baseline may be used to compare to incoming signals and identify signals deviating from the baseline for a given cycle; figures 4; paragraphs [0100-0102, 0106-0108]); and
responsive to determining that the data in at least a threshold number of the plurality of possible pairs of the plurality of time segments are repetitive with respect to one another (the signal baseline may be used to compare to incoming signals and identify signals deviating from the baseline for a given cycle and compare to selected criteria such as attitude to evaluate if there is a deviation and adjust the presentation of the presented map; figures 4; paragraphs [0100-0102, 0106-0108]), selecting a polar coordinate system for the plot type for visualizing the selected physiologic data (different types of maps, annotations of waveforms and annotations of histograms may be chosen based on alignment to a cardiac or biological cycles, including mapping the 3d signals which may be aligned to polar coordinates; figures 1-3; paragraphs [0063, 0086, 0089, 0096, 0133]).
Regarding claim 5, Stewart discloses the apparatus of claim 4 wherein, responsive to determining that the data in at least the threshold number of the plurality of possible pairs of the plurality of time segments are not repetitive with respect to one another (the signal baseline may be used to compare to incoming signals and identify signals deviating from the baseline for a given cycle and compare to selected criteria such as attitude to evaluate if there is a deviation; figures 4; paragraphs [0100-0102, 0106-0108]), selecting a Cartesian coordinate system for the plot type for visualizing the selected physiologic data (different types of maps, annotations of waveforms and annotations of histograms may be chosen based on alignment to a cardiac or biological cycles, including mapping the 3d signals which may be aligned to cartesian coordinates; figures 1-3; paragraphs [0063, 0086, 0089, 0096, 0133]).
Regarding claim 6, Stewart discloses the apparatus of claim 4 wherein the threshold number of the plurality of possible pairs of the plurality of time segments comprises a designated percentage of a total number of the plurality of possible pairs of the plurality of time segments (deviations may be determined by measuring relative deviations from base line and determining the probability for each sample point is a deviation and refining the model by comparing surrounding points to obtain a confidence level with a threshold assigned to determine if the signal is deviant; figures 4; paragraphs (0106-0111]).
Regarding claim 7, Stewart discloses the apparatus of claim 4, wherein determining the plot type for visualization of the selected physiologic data further comprises identifying a set of supported time segment sizes (signal deviations may be examined by setting a time window and determining the signal baseline within that window; figures 4; paragraphs [0100-0102]), and performing one or more iterations of (i) dividing the given period of time into the plurality of time segments utilizing a given one of the set of supported time segment sizes (different types of maps, annotations of waveforms and annotations of histograms may be chosen based on alignment to a cardiac or biological cycles (given period of time); signal deviations may be examined by setting a time window and determining the signal baseline within that window; figures 1-4; paragraphs [0086, 0096, 0100-0102, 0133]) and (ii) comparing the data in at least the subset of the plurality of possible pairs of the plurality of time segments of the given supported time segment size (deviations may be determined by measuring relative deviations from base line within each sample window and determining the probability for each sample point in that window is a deviation from the base line value; figures 4; paragraphs [0106-0111]), until a determination is made that the data in at least the threshold number of the plurality of possible pairs of the plurality of time segments of the given supported time segment size are repetitive with respect to one another (deviations may be determined by measuring relative deviations from base line within a sample window and determining the probability for each sample point in that window is a deviation and refining the model by comparing surrounding points to obtain a confidence level and assigned a threshold to determine if the signal is deviant or stays within the threshold (repetitive); figures 4; paragraphs [0106-0111]).
Regarding claim 8, Stewart discloses the apparatus of claim 7, wherein a first one of the one or more iterations utilizes a smallest one of the set of supported time segment sizes and one or more subsequent ones of the one or more iterations utilize next largest ones of the set of supported time segment sizes (signal deviations may be examined by setting a time window and determining the signal baseline within that window, with the time window being adjustable and one or more time periods being identified; figures 4; paragraphs [0100-0102]).
Regarding claim 10, Stewart discloses the apparatus of claim 7, wherein responsive to determining that the data in at least the threshold number of the plurality of possible pairs of the plurality of time segments are not repetitive with respect to one another in at least a threshold number of the one or more iterations (the signal baseline may be used to compare to incoming signals and identify signals deviating from the baseline for a given cycle and compare to selected criteria such as attitude to evaluate if there is a deviation; figures 4; paragraphs [0100-0102, 0106-0108]), selecting a Cartesian coordinate system for the plot type for visualizing the selected physiologic data (different types of maps, annotations of waveforms and annotations of histograms may be chosen based on alignment to a cardiac or biological cycles, including mapping the 3d signals which may be aligned to cartesian coordinates; figures 1-3; paragraphs [0063, 0086, 0089, 0096, 0133]).
Regarding claim 11, Stewart discloses the apparatus of claim 4, wherein selecting the physiologic data to be visualized further comprises identifying one or more annotations associated with one or more designated time ranges within the given period of time (first screen region 632 includes a GUI which displays activation histogram 644 against a time series alongside the anointed map in the second region 634; figures 6A and 6B; paragraphs [0144, 0145, 0151, 0152]), and wherein outputting the generated visualization of the selected physiologic data via the interactive graphical user interface comprises displaying one or more user-activable interface features for the one or more annotations at respective points along a circumference of a polar coordinate plot of the generated visualization corresponding to the one or more designated time ranges within the given period of time (the activation histogram 644 is plotted along the time period and corresponds to the polar cardiac map, with the user being able to select a period of time by selecting a portion of the histogram 644 which will cause features on the polar cardiac map corresponding to the elected events to be selected and highlighted; figures 68; paragraphs [0145, 0147-0149, 0151]).
Regarding claim 12, Stewart discloses the apparatus of claim 11, wherein at least a given one of the one or more annotations comprises one or more contextual events associated with the given subject at a given one of the one or more designated time ranges (activation histogram 644 may correspond to electrode data or may correspond to other annotation events such as cardiac events within the timeframe of the signal; figures 68; paragraphs [0133, 0145, 0148, 0149, 0153]).
Regarding claim 15, Stewart discloses the apparatus of claim 4, wherein outputting the generated visualization of the selected physiologic data via the interactive graphical user interface comprises providing one or more user-activatable interface features for overlaying one or more filters on a polar coordinate plot of the generated visualization (the cardiac map may have different sections which a user may select and then color the polar coordinate based map using chosen colors and based on the annotations, for example vectors, activation, blood flow, etc.; figures 6A and 6B; paragraphs [0063, 0096, 0138, 0142, 0147]).
Regarding claim 18, Stewart discloses the apparatus of claim 15, wherein at least a given one of the one or more filters comprises displaying a threshold value of a given one of the one or more physiologic parameters as a ring on the polar coordinate plot (a user may select a portion 67 4 of the map using a circular tool to highlight portions of activation histogram 644, which represents deviations from the threshold, and creating a border 676 (ring) around an internal area 678; figures 68; paragraphs [0111, 0148-0149, 0152]).
Claims 19 and 20 are similar in scope to claim 1, and therefore the examiner provides similar rationale to reject these claims. Moreover, Stewart teaches the claimed computer readable medium ([0083]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 9, 13 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart, and further in view of Couderc et al. (US 2017/0156619, hereinafter Couderc).
Regarding claim 9, Steward does not explicitly disclose the apparatus of claim 8, wherein the smallest one of the set of supported time segment sizes comprises one day.
However, Couderc discloses wherein the smallest one of the set of supported time segment sizes comprises one day (a polar plot representing an ECG clock over the period of one day may be stack to form long periods such as days or weeks; figures 1 and 3; paragraphs [0024, 0026)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Stewart to provide wherein the smallest one of the set of supported time segment sizes comprises one day, as taught by Couderc, in order to provide the advantage of displaying cardiac activity over long periods of time to determine long QT syndrome (Abstract).
Regarding claim 16, Stewart discloses the apparatus of claim 15, but Stewart does not explicitly disclose wherein each of the plurality of time segments comprises one day, and wherein at least a given one of the one or more filters comprises overlaying visual indicators of daytime and nighttime on the polar coordinate plot.
However, Couderc discloses wherein each of the plurality of time segments comprises one day (a polar plot representing an ECG clock over the period of one day may be stack to form long periods such as days or weeks; figures 1 and 3; paragraphs [0024, 0026]), and wherein at least a given one of the one or more filters comprises overlaying visual indicators of daytime and nighttime on the polar coordinate plot (filters for normal and abnormal heart ranges may be created with the filter boundaries depending on day and night to adjust for sleep, changing the color boundaries based on probable sleep times; figures 1, 3 and 5-6; paragraphs [0025, 0026, 0053, 0054]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Stewart to provide wherein each of the plurality of time segments comprises one day, and wherein at least a given one of the one or more filters comprises overlaying visual indicators of daytime and nighttime on the polar coordinate plot, as taught by Couderc, in order to provide the advantage of an indicator able to easily show changes to normal heart rate during sleep times to indicate issues such as long QT syndrome (Couderc paragraph (0053-0054]).
Regarding claim 17, Stewart discloses the apparatus of claim 15, but Stewart does not explicitly disclose wherein each of the plurality of time segments comprises one day, and wherein at least a given one of the one or more filters comprises overlaying visual indicators of a sleep state of a given one of the one or more subjects on the polar coordinate plot.
However, Couderc discloses wherein each of the plurality of time segments comprises one day (a polar plot representing an ECG clock over the period of one day may be stack to form long periods such as days or weeks; figures 1 and 3; paragraphs [0024, 0026]), and wherein at least a given one of the one or more filters comprises overlaying visual indicators of a sleep state of a given one of the one or more subjects on the polar coordinate plot (filters for normal and abnormal heart ranges may be created with the filter boundaries depending on day and night to adjust for sleep, changing the color boundaries based on probable sleep times for the user; figures 1, 3 and 5-6; paragraphs [0025, 0026, 0053, 0054]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Stewart to provide wherein each of the plurality of time segments comprises one day, wherein at least a given one of the one or more filters comprises overlaying visual indicators of a sleep state of a given one of the one or more subjects on the polar coordinate plot, as taught by Couderc, in order to provide the advantage of an indicator able to easily show changes to normal heart rate during sleep times to indicate issues such as long QT syndrome (Couderc paragraph (0053-0054]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart, in view of Couderc, and further in view of Albrecht et al. (US 6047206, hereinafter Albrecht).
Regarding claim 13, Stewart discloses wherein at least a given one of the one or more contextual events comprises at least one of: a change in posture or position of the given subject (an orientation indicator 654 may be configured to indicate the orientation, with respect to the body housing the heart, of the cardiac map that corresponds to the particular view 650, 652; fig. 6A-6B and [0141] and [0145]).
Stewart does not explicitly disclose wherein at least a given one of the one or more contextual events comprises at least one of: administering a medication to the given subject; an indication of pain or discomfort of the given subject; an indication of a sleep state of the given subject; and an indication of a physical activity level of the given subject.
Couderc discloses wherein at least a given one of the one or more contextual events comprises at least one of: administering a medication to the given subject (the polar plots may be annotated to show baseline data compared to the data after a drug is given in the morning to the subject; figures 5; paragraphs [0051- 0053]); an indication of pain or discomfort of the given subject; an indication of a sleep state of the given subject (filters for normal and abnormal heart ranges may be created with the filter boundaries depending on day and night to adjust for sleep, changing the color boundaries based on probable sleep times for the user; figures 1, 3 and 5-6; paragraphs [0025, 0026, 0053, 0054]); and an indication of a physical activity level of the given subject (The ECG clock provides an instrument or visual representation of the change in ECG value with a change in stimulus or event. The actions that may be taken to correct or modify the stimuli or event that resulted in the change in ECG variable may include, for example exercise regimen, paragraph [0009]; the heart rate plot may be annotated to typical range of values for the healthy population, but the values outside of that range could be due to exercise; figures 5; paragraphs [0051- 0053]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Stewart to provide wherein at least a given one of the one or more contextual events comprises at least one of: administering a medication to the given subject; an indication of a sleep state of the given subject; and an indication of a physical activity level of the given subject, as taught by Couderc, in order to provide the advantage of displaying cardiac activity over long periods of time to display the effect of the drug.
Albrecht discloses wherein at least a given one of the one or more contextual events comprises at least one of: an indication of pain or discomfort of the given subject (the time plot may be annotated with markers to indicate the time of symptoms or other events (e.g., chest pain) or the start of therapy (e.g., thrombolysis) … The dotted lines 1815 may represent annotated events, such as the onset of chest pain or the start of thrombolytic therapy; col. 13 lines 55-57 and col. 14 lines 30-32). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Stewart to provide wherein at least a given one of the one or more contextual events comprises at least one of: an indication of pain or discomfort of the given subject, as taught by Albrecht, to generate localized cardiac measures for use in detecting a myocardial infarction (i.e., a heart attack) when a patient appears in an emergency room with symptoms, such as chest pain, dizziness or malaise (col. 1 lines 48-58).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart, and further in view of Gunderson (US 2009/0299201).
Regarding claim 14, Stewart discloses the apparatus of claim 12, but Stewart does not explicitly disclose wherein the given annotation comprises a voice recording captured by a given one of the subjects or a caregiver of the given subject, the voice recording describing at least a given one of the one or more contextual events.
Gunderson discloses wherein the given annotation comprises a voice recording captured by a given one of the subjects or a caregiver of the given subject, the voice recording describing at least a given one of the one or more contextual events (the clinician input may identify one or more of annotations 158, 162, 166 and may include voice recordings which are provided to identify certain data events and trends identified; figures 7 and 9; paragraphs [0091, 0101-0103]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Stewart to provide wherein the given annotation comprises a voice recording captured by a given one of the subjects or a caregiver of the given subject, the voice recording describing at least a given one of the one or more contextual events, as taught by Gunderson, in order to provide the advantage of an indicator able to identify specific events and provide alerts to the user when their health is in danger.
Response to Arguments
Applicant's arguments filed 7/72026 have been fully considered but they are not persuasive.
Response to the argument that the double patenting rejection is rendered moot by the amendments to the claims. See page 8 of Applicant’s Remarks.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from claims 1-14, 19 and 20 of US Patent No. 12,131,413.
In this instant case, the added limitation to independent claims 1, 19 and 20 recites “wherein determining the plot type for the visualization comprises selecting among two or more different coordinate systems for the plot type based at least in part on determining that the selected physiologic data has one or more threshold levels of repetitiveness over the plurality of time segments in the given period of time”. Claim 1 of US Patent No. 12,131,413 recites the limitation “wherein determining the plot type for the visualization comprises (i) selecting a polar coordinate plot type responsive to determining that the selected physiologic data has at least a threshold level of repetitiveness over the plurality of time segments in the given period of time and (ii) selecting a Cartesian coordinate plot type responsive to determining that the selected physiologic data does not have at least the threshold level of repetitiveness over the plurality of time segments in the given period of time”. Claim 1 of US Patent No. 12,131,413 describes two different plot types for visualization and how they are selected based on a threshold level of repetitiveness over the plurality of time segments in the given period of time. Claim 1 of the instant application describes to select a plot type from among two or more different coordinate systems based on a threshold level of repetitiveness over the plurality of time segments in the given period of time. Therefore, claim 1 of the instant application can determine the plot type for the visualization by selecting either the polar coordinate plot type or the Cartesian coordinate plot type as recited in claim 1 of US Patent No. 12,131,413. This selection is performed based at least in part of determining that the selected physiological data has a threshold level of repetitiveness over the plurality of time segments in the given period of time or based at least on determining the select physiological data has at least a lower level of repetitiveness than the threshold level of repetitiveness over the plurality of time segments in the given period of time. Therefore, the claim is properly subjected to ODP rejection.
Response to the argument that the cited references fail to disclose at least the newly added features of the independent claims.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
It should be noted that the Applicant does not address how the newly added limitations are different from the cited references. In this instant case, Stewart is interpreted to teach the newly added limitation: wherein determining the plot type for the visualization comprises selecting among two or more different coordinate systems for the plot type (“ … sensed cardiac signals may include three-dimensional Cartesian coordinates, polar coordinates, and/or the like”; different types of maps, annotations of waveforms and annotations of histograms may be chosen based on alignment to a cardiac or biological cycles, including mapping the 3d signals which may be aligned to cartesian coordinates or polar coordinates; figures 1-3; paragraphs [0063, 0086, 0089, 0096, 0133]) based at least in part on determining that the selected physiologic data has one or more threshold levels of repetitiveness over the plurality of time segments in the given period of time (the signal baseline may be used to compare to incoming signals and identify signals deviating from the baseline for a given cycle and compare to selected criteria such as attitude to evaluate if there is a deviation and adjust the presentation of the presented map; figures 4; paragraphs [0100-0102, 0106-0108]).
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.
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/JWALANT AMIN/Primary Examiner, Art Unit 2612
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