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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9,11-20,22-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) mental processes – concepts performed in the human mind.
Regarding claim 1, with the exception of the recitation of the limitation ‘by each of the plurality of medical devices’, the claim recites concepts performed in the human mind.
The limitations ‘defining an incident as the occurrence of a plurality of required alarms from each of a plurality of medical devices; enabling adjustment of the threshold of one or more of the plurality of medical devices, thus defining an adjusted threshold; thus defining a plurality of detected alarms; processing one or more of the plurality of detected alarms to determine an authenticity of the one or more of the plurality of detected alarms, including defining one or more of: volatility information, wherein the volatility information includes a comparison of a variance of data signals from at least one of the plurality of medical devices over a first time period to a variance of the data signals from the at least one of the plurality of medical devices over a second timer period, the second time period being longer than the first time period; bias information; and persistence information; defining the incident as having occurred if the plurality of detected alarms includes the plurality of required alarms; defining a bespoke monitoring parameter for one or more of the plurality of medical devices when one or more of the detected alarms are determined to be non-authentic’ are mental processes -concepts performed in the human mind by observation, evaluation, judgment, and/or opinion, as well as organizing.
Step 2A: Prong two
This judicial exception is not integrated into a practical application because the limitations ‘monitoring physiological characteristics associated with a patient; monitoring the plurality of medical devices to detect the occurrence of alarms; generating an alarm when a monitored physiological characteristic associated with the patent is outside of a threshold; receiving data signals from each of the plurality of medical devices; generating a graphical representation of a level at which the threshold is current being exceeded and a representation of a level at which the adjusted threshold would be exceeded’ are merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)), in this case data gathering and generating an alarm.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the limitations ‘by each of the plurality of medical devices’ are mere instructions to implement an abstract idea or other exception on a computer and in this case generic computer components (MPEP 2106.05(f)).
Regarding claim 2, the limitation ‘defining an incident as the occurrence of a plurality of required alarms includes: defining an incident as the occurrence of a plurality of required alarms within a defined period of time’ are mental processes -concepts performed in the human mind by observation, evaluation, judgment, and/or opinion.
Regarding claim 3, the limitation ‘monitoring a plurality of medical devices to detect the occurrence of alarms includes: monitoring the plurality of medical devices to receive data signals indicative of the plurality of medical devices’ is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)), in this case data gathering.
Regarding claim 4, the limitation ‘the data signals concern one or more details of the plurality of medical devices and/or one or more uses of the plurality of medical devices’ is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)), in this case data gathering.
Regarding claim 5, the limitation ‘monitoring a plurality of medical devices to detect the occurrence of alarms further includes: comparing the data signals to defined signal norms to identify one or more of the plurality of detected alarms’ are mental processes -concepts performed in the human mind by observation, evaluation, judgment, and/or opinion.
Regarding claim 6, the limitation ‘the defined signal norms include user-defined signal norms’ is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)), in this case data gathering.
Regarding claim 7, the limitation ‘the defined signal norms include machine-defined signal norms’ is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)), in this case data gathering.
Regarding claim 8, the limitation ‘the machine-defined signal norms are defined via massive data sets that are processed by machine learning’ are mere instructions to implement an abstract idea or other exception on a computer and in this case generic computer components (MPEP 2106.05(f)).
Regarding claim 9, the limitation ‘the machine-defined signal norms are compartmentalized (e.g., gender, race, age, location, device type, device class, seasonality, time of day, etc.)’ is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)), in this case data gathering.
Regarding claim 11, the limitation ‘the plurality of devices are geographically dispersed’ are mere instructions to implement an abstract idea or other exception on a computer and in this case generic computer components (MPEP 2106.05(f)).
Regarding claim 12, with the exception of the recitation of the limitation ‘A computer program product residing on a non-transitory computer readable medium having a plurality of instructions stored thereon which, when executed by a processor, cause the processor to perform operations; by each of the plurality of medical devices’, the claim recites concepts performed in the human mind.
The limitations ‘defining an incident as the occurrence of a plurality of required alarms from each of a plurality of medical devices; enabling adjustment of the threshold of one or more of the plurality of medical devices, thus defining an adjusted threshold; thus defining a plurality of detected alarms; processing one or more of the plurality of detected alarms to determine an authenticity of the one or more of the plurality of detected alarms, including defining one or more of: volatility information, wherein the volatility information includes a comparison of a variance of data signals from at least one of the plurality of medical devices over a first time period to a variance of the data signals from the at least one of the plurality of medical devices over a second timer period, the second time period being longer than the first time period; bias information; persistence information; and stationary information; defining the incident as having occurred if the plurality of detected alarms includes the plurality of required alarms; defining a bespoke monitoring parameter for one or more of the plurality of medical devices when one or more of the detected alarms are determined to be non-authentic’ are mental processes – concepts performed in the human mind by observation, evaluation, judgment, and/or opinion, as well as organizing.
Step 2A: Prong two
This judicial exception is not integrated into a practical application because the limitations ‘monitoring physiological characteristics associated with a patient; monitoring the plurality of medical devices to detect the occurrence of alarms, thus defining a plurality of detected alarms; generating an alarm when a monitored physiological characteristic associated with the patent is outside of a threshold; receiving data signals from each of the plurality of medical devices; generating a graphical representation of a level at which the threshold is current being exceeded and a representation of a level at which the adjusted threshold would be exceeded’ are merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)), in this case data gathering and generating an alarm.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the limitations ‘A computer program product residing on a non-transitory computer readable medium having a plurality of instructions stored thereon which, when executed by a processor, cause the processor to perform operations; by each of the plurality of medical devices’ are mere instructions to implement an abstract idea or other exception on a computer and in this case generic computer components (MPEP 2106.05(f)).
As for the limitations recited in claims 13-20,22, when considering each of the
Regarding claim 13, the limitation ‘defining an incident as the occurrence of a plurality of required alarms includes: defining an incident as the occurrence of a plurality of required alarms within a defined period of time’ are mental processes -concepts performed in the human mind by observation, evaluation, judgment, and/or opinion.
Regarding claim 14, the limitation ‘monitoring a plurality of medical devices to detect the occurrence of alarms includes: monitoring the plurality of medical devices to receive data signals indicative of the plurality of medical devices’ is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)), in this case data gathering.
Regarding claim 15, the limitation ‘the data signals concern one or more details of the plurality of medical devices and/or one or more uses of the plurality of medical devices’ is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)), in this case data gathering.
Regarding claim 16, the limitation ‘monitoring a plurality of medical devices to detect the occurrence of alarms further includes: comparing the data signals to defined signal norms to identify one or more of the plurality of detected alarms’ are mental processes -concepts performed in the human mind by observation, evaluation, judgment, and/or opinion.
Regarding claim 17, the limitation ‘the defined signal norms include user-defined signal norms’ is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)), in this case data gathering.
Regarding claim 18, the limitation ‘the defined signal norms include machine-defined signal norms’ is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)), in this case data gathering.
Regarding claim 19, the limitation ‘the machine-defined signal norms are defined via massive data sets that are processed by machine learning’ are mere instructions to implement an abstract idea or other exception on a computer and in this case generic computer components (MPEP 2106.05(f)).
Regarding claim 20, the limitation ‘the machine-defined signal norms are compartmentalized (e.g., gender, race, age, location, device type, device class, seasonality, time of day, etc.)’ is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)), in this case data gathering.
Regarding claim 22, the limitation ‘the plurality of devices are geographically dispersed’ are mere instructions to implement an abstract idea or other exception on a computer and in this case generic computer components (MPEP 2106.05(f)).
Regarding claim 23, with the exception of the recitation of the limitation ‘a processor and memory; by each of the plurality of medical devices’, the claim recites concepts performed in the human mind.
The limitations ‘defining an incident as the occurrence of a plurality of required alarms from each of a plurality of medical devices; enabling adjustment of the threshold of one or more of the plurality of medical devices, thus defining an adjusted threshold; thus defining a plurality of detected alarms; processing one or more of the plurality of detected alarms to determine an authenticity of the one or more of the plurality of detected alarms, including defining one or more of: volatility information, wherein the volatility information includes a comparison of a variance of data signals from at least one of the plurality of medical devices over a first time period to a variance of the data signals from the at least one of the plurality of medical devices over a second timer period, the second time period being longer than the first time period; bias information; persistence information; and stationary information; defining the incident as having occurred if the plurality of detected alarms includes the plurality of required alarms; defining a bespoke monitoring parameter for one or more of the plurality of medical devices when one or more of the detected alarms are determined to be non-authentic’ are mental processes -concepts performed in the human mind by observation, evaluation, judgment, and/or opinion, as well as organizing.
Step 2A: Prong two
This judicial exception is not integrated into a practical application because the limitations ‘monitoring physiological characteristics associated with a patient; monitoring the plurality of medical devices to detect the occurrence of alarms, thus defining a plurality of detected alarms; generating an alarm when a monitored physiological characteristic associated with the patent is outside of a threshold; receiving data signals from each of the plurality of medical devices; generating a graphical representation of a level at which the threshold is current being exceeded and a representation of a level at which the adjusted threshold would be exceeded’ are merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)), in this case data gathering and generating an alarm.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the limitations ‘a processor and memory; by each of the plurality of medical devices’ are mere instructions to implement an abstract idea or other exception on a computer and in this case generic computer components (MPEP 2106.05(f)).
Regarding claim 24, the limitation ‘defining an incident as the occurrence of a plurality of required alarms includes: defining an incident as the occurrence of a plurality of required alarms within a defined period of time’ are mental processes -concepts performed in the human mind by observation, evaluation, judgment, and/or opinion.
Regarding claim 25, the limitation ‘monitoring a plurality of medical devices to detect the occurrence of alarms includes: monitoring the plurality of medical devices to receive data signals indicative of the plurality of medical devices’ is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)), in this case data gathering.
Regarding claim 26, the limitation ‘the data signals concern one or more details of the plurality of medical devices and/or one or more uses of the plurality of medical devices’ is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)), in this case data gathering.
Regarding claim 27, the limitation ‘monitoring a plurality of medical devices to detect the occurrence of alarms further includes: comparing the data signals to defined signal norms to identify one or more of the plurality of detected alarms’ are mental processes -concepts performed in the human mind by observation, evaluation, judgment, and/or opinion.
Regarding claim 28, the limitation ‘the defined signal norms include user-defined signal norms’ is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)), in this case data gathering.
Regarding claim 29, the limitation ‘the defined signal norms include machine-defined signal norms’ is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)), in this case data gathering.
Regarding claim 30, the limitation ‘the machine-defined signal norms are defined via massive data sets that are processed by machine learning’ are mere instructions to implement an abstract idea or other exception on a computer and in this case generic computer components (MPEP 2106.05(f)).
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.
Claim(s) are rejected under 35 U.S.C. 103 as being unpatentable over Boyer (USPN 20160093205A1) in view of Al-Ali (USPN 20170231537A1) in further view of Treacy et al. (USPN 20180096110A).
As per claim 1, Boyer discloses a computer-implemented method, executed on a computing device, comprising: defining an incident as the occurrence of a plurality of required alarms from each of a plurality of medical devices (paragraph 0043 - For example, the physiological signal or physiologic data may be received from a sensor (e.g., the sensor 14) or from one or more local or remote medical devices.; paragraph 0025 - An alarm is generated by a medical device (such as the monitor 12 or a therapeutic device, such as a ventilator) when an alarm condition or protocol is met. Alarm conditions include several types, such as physiologic alarm conditions, patient event alarm conditions, and device alarm conditions…. Further, alarm conditions may be based on a combination of different alarm conditions, such as two physiologic parameters each violating a respective limit, a combined alarm index violating a limit, or specified combinations of monitor and sensor status events.; paragraph 0055 - In another embodiment, analysis of the collected relevance event data may reveal a relationship between two or more physiologic parameters, and modifying the alarm condition may include combining alarm conditions from two or more physiologic parameters. The new combined alarm is not triggered unless both (or all) conditions are met.);
monitoring, by each of the plurality of medical devices, physiological characteristics associated with a patient (paragraph 0043 - For example, the physiological signal or physiologic data may be received from a sensor (e.g., the sensor 14) or from one or more local or remote medical devices.);
generating, by each of the plurality of medical devices, an alarm when a monitored physiological characteristic associated with the patient is outside of a threshold (paragraph 0025 - An alarm is generated by a medical device (such as the monitor 12 or a therapeutic device, such as a ventilator) when an alarm condition or protocol is met. Alarm conditions include several types, such as physiologic alarm conditions, patient event alarm conditions, and device alarm conditions…. Further, alarm conditions may be based on a combination of different alarm conditions, such as two physiologic parameters each violating a respective limit, a combined alarm index violating a limit, or specified combinations of monitor and sensor status events.; paragraph 0055 - In another embodiment, analysis of the collected relevance event data may reveal a relationship between two or more physiologic parameters, and modifying the alarm condition may include combining alarm conditions from two or more physiologic parameters. The new combined alarm is not triggered unless both (or all) conditions are met.);
enabling adjustment of the threshold of one or more of the plurality of medical devices, thus defining an adjusted threshold (paragraph 0054 - Modifying the alarm conditions may include changing an alarm threshold, such as moving it up or down, to reduce the number of alarm events. For example, an alarm condition may include a lower threshold of 90% for oxygen saturation, and modifying this alarm condition may include reducing the threshold to 89% or 85% or other appropriate value.);
monitoring the plurality of medical devices, including receiving data signals from each of the plurality of medical devices, to detect the occurrence of alarms, thus defining a plurality of detected alarms (paragraph 0043 - collecting relevance data for triggered alarms in accordance with an embodiment. The method 250 includes receiving a physiological signal or physiologic data (block 252). For example, the physiological signal or physiologic data may be received from a sensor (e.g., the sensor 14) or from one or more local or remote medical devices… The method 250 also includes determining whether the physiological signal or physiologic data meets an alarm condition (block 254)… In response to determining that the physiological signal or physiologic data meets the alarm condition, the method 250 includes generating an alarm (block 256). Additionally, the method 250 includes receiving a relevance indicator (e.g., the relevance indicator 220) indicating the relevance of the generated alarm (block 258) and storing the relevance indicator and the alarm condition (block 260).; paragraph 0055 - In another embodiment, analysis of the collected relevance event data may reveal a relationship between two or more physiologic parameters, and modifying the alarm condition may include combining alarm conditions from two or more physiologic parameters. The new combined alarm is not triggered unless both (or all) conditions are met.);
defining a bespoke monitoring parameter for one or more of the plurality of medical devices when one or more of the detected alarms are determined to be non-authentic (paragraph 0020 - Alarms that do not correspond to a clinically significant event may be referred to as nuisance alarms or false alarms. In an embodiment, a medical device, such as a monitoring device or a therapeutic device, includes a user input that receives an indicator of the relevance or significance of a generated alarm. When an alarm is generated, the caregiver who responds to the alarm can provide feedback by activating the user input to indicate the relevance of the alarm. For example, the user input may press a button or select an icon to generate an indicator that the triggered alarm corresponded to a clinically significant or relevant event, or that the triggered alarm did not correspond to a clinically significant or relevant event. In another example, the user input may include a rating scale that receives a numerical value from the user regarding the relevance of the alarm on a numerical scale. Thus, the relevance indicator may be a binary indication (relevant or not relevant), a numerical value (indicating a relevance value), a category, or other inputs as described below. The medical device receives this feedback and stores the relevance indicator along with information about the alarm event, such as the alarm condition, the medical device status, and the patient's physiological status. Together, this relevance event data is then further analyzed to identify alarm protocols that have low relevance, and to modify those alarm protocols or to create new alarm protocols that decrease the prevalence of nuisance alarms. – non-authentic is a low relevance alarm and the bespoke monitoring parameter is the determining a nuisance alarm); and
defining the incident as having occurred if the plurality of detected alarms includes the plurality of required alarms (paragraph 0025 - An alarm is generated by a medical device (such as the monitor 12 or a therapeutic device, such as a ventilator) when an alarm condition or protocol is met. Alarm conditions include several types, such as physiologic alarm conditions, patient event alarm conditions, and device alarm conditions…. Further, alarm conditions may be based on a combination of different alarm conditions, such as two physiologic parameters each violating a respective limit, a combined alarm index violating a limit, or specified combinations of monitor and sensor status events.; paragraph 0055 - In another embodiment, analysis of the collected relevance event data may reveal a relationship between two or more physiologic parameters, and modifying the alarm condition may include combining alarm conditions from two or more physiologic parameters. The new combined alarm is not triggered unless both (or all) conditions are met.; paragraph 0065 - The method 330 also includes identifying nuisance alarms based on the relevance values (block 340). As described in detail above, identifying the nuisance alarms may include identifying an alarm condition that has a low relevance value, identifying an alarm condition that has a high irrelevance value, or identifying patterns of data with low relevance values or high irrelevance values. Further, as noted above, identifying the nuisance alarms may include statistic analysis of the relevance event data and relevance values.).
Boyer fails to explicitly state processing one or more of the plurality of detected alarms to determine an authenticity of the one or more of the plurality of detected alarms, including defining one or more of: volatility information; bias information; and persistence information.
Boyer does disclose in paragraph 0025 - An alarm is generated by a medical device (such as the monitor 12 or a therapeutic device, such as a ventilator) when an alarm condition or protocol is met. Alarm conditions include several types, such as physiologic alarm conditions, patient event alarm conditions, and device alarm conditions.
Al-Ali does disclose processing one or more of the plurality of detected alarms to determine an authenticity of the one or more of the plurality of detected alarms, including defining one or more of: volatility information, wherein the volatility information includes a comparison of a variance of data signals from at least one of the plurality of medical devices over a first time period to a variance of the data signals from the at least one of the plurality of medical devices over a second timer period, the second time period being longer than the first time period; bias information; and persistence information in paragraph 0014 - Another aspect of an adaptive alarm system measures a physiological parameter, establishes a baseline for the parameter, adjusts an alarm threshold according to drift of the baseline and triggers an alarm in response to the parameter measurement crossing the alarm threshold. In various embodiments, the baseline is established by biasing a segment of the parameter, calculating a biased trend from the biased segment and restricting the transient response of the biased trend.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include alarm events being triggered based on the baseline is established by biasing a segment of the parameter, calculating a biased trend from the biased segment and restricting the transient response of the biased trend of Al-Ali in the physiological alarm conditions in Boyer. A person of ordinary skill in the art would have been motivated to make the modification because alarm events are determined based on the baseline and its drift, as disclosed in paragraph 0014.
Boyer and Al-Ali fail to explicitly state generating a graphical representation of a level at which the threshold is current being exceeded and a representation of a level at which the adjusted threshold would be exceeded.
Boyer does disclose in paragraph 0023 - The display 16 may also display information related to alarms, monitor settings, and/or signal quality. In certain embodiments, the display 16 may be a touch screen display.
Treacy et al. discloses generating a graphical representation of a level at which the threshold is current being exceeded and a representation of a level at which the adjusted threshold would be exceeded in paragraph 0048 - In an exemplary embodiment, two alarms are associated with the heart rate physiological data. Specifically, a low heart rate limit 186 and a high heart rate limit 188. The current heart rate alarm limit values associated with these alarms are visually presented on the histogram 182 in relation to the histogram relating the associated physiological data of the patient for the particular parameter alarm (heart rate) being considered. The user is able to use this GUI 180 to test prospective new limits for the parameter alarms by entering new threshold values in the user interface 190. By selecting the update histogram button the user interface 190, the histogram 182 can update to graphically depict the prospective low heart rate alarm value 192 which is exemplarily 40 beats per minute and to reflect the proposed high heart rate alarm value 194 which exemplarily is proposed to be adjusted to 155 beats per minute. By making such an adjustment, the prospective analysis portion 184 is updated in a prospective reporting section 196 to indicate the proposed new alarm limit values.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a GUI displaying low heart rate limit, a high heart rate limit, and current hear rate alarm limit values of Treacy in displaying information relating to alarms and other information of Boyer. A person of ordinary skill in the art would have been motivated to make the modification because identifying and implementing interventions to address alarm burden require monitoring, visualization, and analysis tools in order to assist clinicians and/or clinical managers in making and implementing such decisions, as disclosed in paragraph 0019.
As per claims 2,13,24, Boyer discloses wherein defining an incident as the occurrence of a plurality of required alarms includes: defining an incident as the occurrence of a plurality of required alarms within a defined period of time (paragraph 0055 - In another embodiment, analysis of the collected relevance event data may reveal a relationship between two or more physiologic parameters, and modifying the alarm condition may include combining alarm conditions from two or more physiologic parameters. The new combined alarm is not triggered unless both (or all) conditions are met… Accordingly, a new alarm protocol may be created that triggers an alarm when these identified conditions are all met at the same time.).
As per claims 3,14,25, Boyer discloses wherein monitoring a plurality of medical devices to detect the occurrence of alarms includes: monitoring the plurality of medical devices to receive data signals indicative of the plurality of medical devices (paragraph 0043 - collecting relevance data for triggered alarms in accordance with an embodiment. The method 250 includes receiving a physiological signal or physiologic data (block 252). For example, the physiological signal or physiologic data may be received from a sensor (e.g., the sensor 14) or from one or more local or remote medical devices… The method 250 also includes determining whether the physiological signal or physiologic data meets an alarm condition (block 254)… In response to determining that the physiological signal or physiologic data meets the alarm condition, the method 250 includes generating an alarm (block 256). Additionally, the method 250 includes receiving a relevance indicator (e.g., the relevance indicator 220) indicating the relevance of the generated alarm (block 258) and storing the relevance indicator and the alarm condition (block 260).).
As per claims 4,15,26, Boyer discloses wherein the data signals concern one or more details of the plurality of medical devices and/or one or more uses of the plurality of medical devices (paragraph 0025 - An alarm is generated by a medical device (such as the monitor 12 or a therapeutic device, such as a ventilator) when an alarm condition or protocol is met. Alarm conditions include several types, such as physiologic alarm conditions, patient event alarm conditions, and device alarm conditions.; paragraph 0043 - collecting relevance data for triggered alarms in accordance with an embodiment. The method 250 includes receiving a physiological signal or physiologic data (block 252). For example, the physiological signal or physiologic data may be received from a sensor (e.g., the sensor 14) or from one or more local or remote medical devices.
As per claims 5,16,27, Boyer discloses wherein monitoring a plurality of medical devices to detect the occurrence of alarms further includes: comparing the data signals to defined signal norms to identify one or more of the plurality of detected alarms (paragraph 0025 - An alarm is generated by a medical device (such as the monitor 12 or a therapeutic device, such as a ventilator) when an alarm condition or protocol is met. Alarm conditions include several types, such as physiologic alarm conditions, patient event alarm conditions, and device alarm conditions. Physiologic alarm conditions trigger an alarm when a measured or calculated physiologic parameter satisfies an alarm condition, such as when the parameter value crosses a threshold, deviates from a specified range, matches a stored pattern, deviates from a threshold for a specified time and/or extent (e.g., exceeding a limit on a value of an integral taken between the parameter value and a threshold), or meets other conditions that indicate a clinically significant event.).
As per claims 6,17,28, Boyer discloses wherein the defined signal norms include user-defined signal norms (paragraph 0035 - Additionally, the stored relevance event data 222 may include information about the patient such as patient characteristics (e.g., age, weight, height, gender, race, condition, diagnosis, or others) or the patient's overall health index. In some embodiments, the patient health index is a numerical value provided by the user. For example, a caregiver may assess the physiological parameter data of the patient and determine a patient health index…In other embodiments, the patient health index 330 may be a numeric value between −5 and 5 or between −3 and 3, where a patient health index of 0 is indicative of an acceptable or normal physiological status and a higher patient health index (positive or negative) is indicative of a worsening physiological status. ).
As per claims 7,18,29, Boyer discloses wherein the defined signal norms include machine-defined signal norms (paragraph 0030 - The physiological input 204 may include an incoming raw or processed physiologic signal, or measured or calculated physiologic data. The physiological input 204 may be received from a sensor coupled to the patient (e.g., the sensor 14) or from other medical devices.; paragraph 0043 - collecting relevance data for triggered alarms in accordance with an embodiment. The method 250 includes receiving a physiological signal or physiologic data (block 252). For example, the physiological signal or physiologic data may be received from a sensor (e.g., the sensor 14) or from one or more local or remote medical devices…Further, in some embodiments, the plurality of physiological signals may include at least two different types of physiological signals (e.g., a photoplethysmograph signal, an electrocardiography signal, a blood pressure signal, etc.) and the plurality of physiological parameter values may include at least two different types of physiological parameter values (e.g., oxygen saturation, heart rate, respiration rate, blood pressure, BISPECTRAL™ index, etc.).).
As per claims 8,19,30, Boyer discloses wherein the machine-defined signal norms are defined via massive data sets that are processed by machine learning (paragraph 0039 - the processor 206 may include a statistical analysis engine or machine learning engine 224. The statistical analysis engine or machine learning engine 224 may analyze the collected relevance event data 222 to identify and modify nuisance alarm conditions.; paragraph 0049 - The data associated with the plurality of generated alarms may include the alarm conditions and other relevance event data, as described in detail above.; paragraph 0052 - Analyzing the data and the relevance indicators may include performing statistical analysis on the collected data…or any other classification or learning-based algorithms).
As per claims 9,20, Boyer discloses wherein the machine-defined signal norms are compartmentalized (e.g., gender, race, age, location, device type, device class, seasonality, time of day, etc.) (paragraph 0057 - Thresholds or other alarm conditions may also vary with patient characteristics such as age, weight, gender, or others. Alarm conditions that rely on multiple parameters may be enabled or disabled based on the available parameters in a particular situation with a particular patient.).
As per claims 11,22, Boyer discloses wherein the plurality of devices are geographically dispersed (paragraph 0043 - For example, the physiological signal or physiologic data may be received from a sensor (e.g., the sensor 14) or from one or more local or remote medical devices.).
As per claim 12, Boyer discloses a computer program product residing on a non-transitory computer readable medium having a plurality of instructions stored thereon which, when executed by a processor (paragraph 0041 – non-transitory machine-readable medium or media having instructions recorded thereon for execution by a processor), cause the processor to perform operations comprising: defining an incident as the occurrence of a plurality of required alarms from each of a plurality of medical devices (paragraph 0043 - For example, the physiological signal or physiologic data may be received from a sensor (e.g., the sensor 14) or from one or more local or remote medical devices.; paragraph 0025 - An alarm is generated by a medical device (such as the monitor 12 or a therapeutic device, such as a ventilator) when an alarm condition or protocol is met. Alarm conditions include several types, such as physiologic alarm conditions, patient event alarm conditions, and device alarm conditions…. Further, alarm conditions may be based on a combination of different alarm conditions, such as two physiologic parameters each violating a respective limit, a combined alarm index violating a limit, or specified combinations of monitor and sensor status events.; paragraph 0055 - In another embodiment, analysis of the collected relevance event data may reveal a relationship between two or more physiologic parameters, and modifying the alarm condition may include combining alarm conditions from two or more physiologic parameters. The new combined alarm is not triggered unless both (or all) conditions are met.);
monitoring, by each of the plurality of medical devices, physiological characteristics associated with a patient (paragraph 0043 - For example, the physiological signal or physiologic data may be received from a sensor (e.g., the sensor 14) or from one or more local or remote medical devices.);
generating, by each of the plurality of medical devices, an alarm when a monitored physiological characteristic associated with the patient is outside of a threshold (paragraph 0025 - An alarm is generated by a medical device (such as the monitor 12 or a therapeutic device, such as a ventilator) when an alarm condition or protocol is met. Alarm conditions include several types, such as physiologic alarm conditions, patient event alarm conditions, and device alarm conditions…. Further, alarm conditions may be based on a combination of different alarm conditions, such as two physiologic parameters each violating a respective limit, a combined alarm index violating a limit, or specified combinations of monitor and sensor status events.; paragraph 0055 - In another embodiment, analysis of the collected relevance event data may reveal a relationship between two or more physiologic parameters, and modifying the alarm condition may include combining alarm conditions from two or more physiologic parameters. The new combined alarm is not triggered unless both (or all) conditions are met.);
enabling adjustment of the threshold of one or more of the plurality of medical devices, thus defining an adjusted threshold (paragraph 0054 - Modifying the alarm conditions may include changing an alarm threshold, such as moving it up or down, to reduce the number of alarm events. For example, an alarm condition may include a lower threshold of 90% for oxygen saturation, and modifying this alarm condition may include reducing the threshold to 89% or 85% or other appropriate value.);
monitoring the plurality of medical devices, including receiving data signals from each of the plurality of medical devices, to detect the occurrence of alarms, thus defining a plurality of detected alarms (paragraph 0043 - collecting relevance data for triggered alarms in accordance with an embodiment. The method 250 includes receiving a physiological signal or physiologic data (block 252). For example, the physiological signal or physiologic data may be received from a sensor (e.g., the sensor 14) or from one or more local or remote medical devices… The method 250 also includes determining whether the physiological signal or physiologic data meets an alarm condition (block 254)… In response to determining that the physiological signal or physiologic data meets the alarm condition, the method 250 includes generating an alarm (block 256). Additionally, the method 250 includes receiving a relevance indicator (e.g., the relevance indicator 220) indicating the relevance of the generated alarm (block 258) and storing the relevance indicator and the alarm condition (block 260).; paragraph 0055 - In another embodiment, analysis of the collected relevance event data may reveal a relationship between two or more physiologic parameters, and modifying the alarm condition may include combining alarm conditions from two or more physiologic parameters. The new combined alarm is not triggered unless both (or all) conditions are met.);
defining a bespoke monitoring parameter for one or more of the plurality of medical devices when one or more of the detected alarms are determined to be non-authentic (paragraph 0020 - Alarms that do not correspond to a clinically significant event may be referred to as nuisance alarms or false alarms. In an embodiment, a medical device, such as a monitoring device or a therapeutic device, includes a user input that receives an indicator of the relevance or significance of a generated alarm. When an alarm is generated, the caregiver who responds to the alarm can provide feedback by activating the user input to indicate the relevance of the alarm. For example, the user input may press a button or select an icon to generate an indicator that the triggered alarm corresponded to a clinically significant or relevant event, or that the triggered alarm did not correspond to a clinically significant or relevant event. In another example, the user input may include a rating scale that receives a numerical value from the user regarding the relevance of the alarm on a numerical scale. Thus, the relevance indicator may be a binary indication (relevant or not relevant), a numerical value (indicating a relevance value), a category, or other inputs as described below. The medical device receives this feedback and stores the relevance indicator along with information about the alarm event, such as the alarm condition, the medical device status, and the patient's physiological status. Together, this relevance event data is then further analyzed to identify alarm protocols that have low relevance, and to modify those alarm protocols or to create new alarm protocols that decrease the prevalence of nuisance alarms. – non-authentic is a low relevance alarm and the bespoke monitoring parameter is the determining a nuisance alarm); and
defining the incident as having occurred if the plurality of detected alarms includes the plurality of required alarms (paragraph 0025 - An alarm is generated by a medical device (such as the monitor 12 or a therapeutic device, such as a ventilator) when an alarm condition or protocol is met. Alarm conditions include several types, such as physiologic alarm conditions, patient event alarm conditions, and device alarm conditions…. Further, alarm conditions may be based on a combination of different alarm conditions, such as two physiologic parameters each violating a respective limit, a combined alarm index violating a limit, or specified combinations of monitor and sensor status events.; paragraph 0055 - In another embodiment, analysis of the collected relevance event data may reveal a relationship between two or more physiologic parameters, and modifying the alarm condition may include combining alarm conditions from two or more physiologic parameters. The new combined alarm is not triggered unless both (or all) conditions are met.).
Boyer fails to explicitly state processing one or more of the plurality of detected alarms to determine an authenticity of the one or more of the plurality of detected alarms, including defining one or more of: volatility information; bias information; and persistence information.
Boyer does disclose in paragraph 0025 - An alarm is generated by a medical device (such as the monitor 12 or a therapeutic device, such as a ventilator) when an alarm condition or protocol is met. Alarm conditions include several types, such as physiologic alarm conditions, patient event alarm conditions, and device alarm conditions.
Al-Ali does disclose processing one or more of the plurality of detected alarms to determine an authenticity of the one or more of the plurality of detected alarms, including defining one or more of: volatility information, wherein the volatility information includes a comparison of a variance of data signals from at least one of the plurality of medical devices over a first time period to a variance of the data signals from the at least one of the plurality of medical devices over a second timer period, the second time period being longer than the first time period; bias information; and persistence information in paragraph 0014 - Another aspect of an adaptive alarm system measures a physiological parameter, establishes a baseline for the parameter, adjusts an alarm threshold according to drift of the baseline and triggers an alarm in response to the parameter measurement crossing the alarm threshold. In various embodiments, the baseline is established by biasing a segment of the parameter, calculating a biased trend from the biased segment and restricting the transient response of the biased trend.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include alarm events being triggered based on the baseline is established by biasing a segment of the parameter, calculating a biased trend from the biased segment and restricting the transient response of the biased trend of Al-Ali in the physiological alarm conditions in Boyer. A person of ordinary skill in the art would have been motivated to make the modification because alarm events are determined based on the baseline and its drift, as disclosed in paragraph 0014.
Boyer and Al-Ali fail to explicitly state generating a graphical representation of a level at which the threshold is current being exceeded and a representation of a level at which the adjusted threshold would be exceeded.
Boyer does disclose in paragraph 0023 - The display 16 may also display information related to alarms, monitor settings, and/or signal quality. In certain embodiments, the display 16 may be a touch screen display.
Treacy et al. discloses generating a graphical representation of a level at which the threshold is current being exceeded and a representation of a level at which the adjusted threshold would be exceeded in paragraph 0048 - In an exemplary embodiment, two alarms are associated with the heart rate physiological data. Specifically, a low heart rate limit 186 and a high heart rate limit 188. The current heart rate alarm limit values associated with these alarms are visually presented on the histogram 182 in relation to the histogram relating the associated physiological data of the patient for the particular parameter alarm (heart rate) being considered. The user is able to use this GUI 180 to test prospective new limits for the parameter alarms by entering new threshold values in the user interface 190. By selecting the update histogram button the user interface 190, the histogram 182 can update to graphically depict the prospective low heart rate alarm value 192 which is exemplarily 40 beats per minute and to reflect the proposed high heart rate alarm value 194 which exemplarily is proposed to be adjusted to 155 beats per minute. By making such an adjustment, the prospective analysis portion 184 is updated in a prospective reporting section 196 to indicate the proposed new alarm limit values.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a GUI displaying low heart rate limit, a high heart rate limit, and current hear rate alarm limit values of Treacy in displaying information relating to alarms and other information of Boyer. A person of ordinary skill in the art would have been motivated to make the modification because identifying and implementing interventions to address alarm burden require monitoring, visualization, and analysis tools in order to assist clinicians and/or clinical managers in making and implementing such decisions, as disclosed in paragraph 0019.
As per claim 23, Boyer discloses a computing system including a processor (paragraph 0030 – processor 206) and memory (paragraph 0030 - memory 210) configured to perform operations comprising: defining an incident as the occurrence of a plurality of required alarms from each of a plurality of medical devices (paragraph 0043 - For example, the physiological signal or physiologic data may be received from a sensor (e.g., the sensor 14) or from one or more local or remote medical devices.; paragraph 0025 - An alarm is generated by a medical device (such as the monitor 12 or a therapeutic device, such as a ventilator) when an alarm condition or protocol is met. Alarm conditions include several types, such as physiologic alarm conditions, patient event alarm conditions, and device alarm conditions…. Further, alarm conditions may be based on a combination of different alarm conditions, such as two physiologic parameters each violating a respective limit, a combined alarm index violating a limit, or specified combinations of monitor and sensor status events.; paragraph 0055 - In another embodiment, analysis of the collected relevance event data may reveal a relationship between two or more physiologic parameters, and modifying the alarm condition may include combining alarm conditions from two or more physiologic parameters. The new combined alarm is not triggered unless both (or all) conditions are met.);
monitoring, by each of the plurality of medical devices, physiological characteristics associated with a patient (paragraph 0043 - For example, the physiological signal or physiologic data may be received from a sensor (e.g., the sensor 14) or from one or more local or remote medical devices.);
generating, by each of the plurality of medical devices, an alarm when a monitored physiological characteristic associated with the patient is outside of a threshold (paragraph 0025 - An alarm is generated by a medical device (such as the monitor 12 or a therapeutic device, such as a ventilator) when an alarm condition or protocol is met. Alarm conditions include several types, such as physiologic alarm conditions, patient event alarm conditions, and device alarm conditions…. Further, alarm conditions may be based on a combination of different alarm conditions, such as two physiologic parameters each violating a respective limit, a combined alarm index violating a limit, or specified combinations of monitor and sensor status events.; paragraph 0055 - In another embodiment, analysis of the collected relevance event data may reveal a relationship between two or more physiologic parameters, and modifying the alarm condition may include combining alarm conditions from two or more physiologic parameters. The new combined alarm is not triggered unless both (or all) conditions are met.);
enabling adjustment of the threshold of one or more of the plurality of medical devices, thus defining an adjusted threshold (paragraph 0054 - Modifying the alarm conditions may include changing an alarm threshold, such as moving it up or down, to reduce the number of alarm events. For example, an alarm condition may include a lower threshold of 90% for oxygen saturation, and modifying this alarm condition may include reducing the threshold to 89% or 85% or other appropriate value.);
monitoring the plurality of medical devices, including receiving data signals from each of the plurality of medical devices, to detect the occurrence of alarms, thus defining a plurality of detected alarms (paragraph 0043 - collecting relevance data for triggered alarms in accordance with an embodiment. The method 250 includes receiving a physiological signal or physiologic data (block 252). For example, the physiological signal or physiologic data may be received from a sensor (e.g., the sensor 14) or from one or more local or remote medical devices… The method 250 also includes determining whether the physiological signal or physiologic data meets an alarm condition (block 254)… In response to determining that the physiological signal or physiologic data meets the alarm condition, the method 250 includes generating an alarm (block 256). Additionally, the method 250 includes receiving a relevance indicator (e.g., the relevance indicator 220) indicating the relevance of the generated alarm (block 258) and storing the relevance indicator and the alarm condition (block 260).; paragraph 0055 - In another embodiment, analysis of the collected relevance event data may reveal a relationship between two or more physiologic parameters, and modifying the alarm condition may include combining alarm conditions from two or more physiologic parameters. The new combined alarm is not triggered unless both (or all) conditions are met.);
defining a bespoke monitoring parameter for one or more of the plurality of medical devices when one or more of the detected alarms are determined to be non-authentic (paragraph 0020 - Alarms that do not correspond to a clinically significant event may be referred to as nuisance alarms or false alarms. In an embodiment, a medical device, such as a monitoring device or a therapeutic device, includes a user input that receives an indicator of the relevance or significance of a generated alarm. When an alarm is generated, the caregiver who responds to the alarm can provide feedback by activating the user input to indicate the relevance of the alarm. For example, the user input may press a button or select an icon to generate an indicator that the triggered alarm corresponded to a clinically significant or relevant event, or that the triggered alarm did not correspond to a clinically significant or relevant event. In another example, the user input may include a rating scale that receives a numerical value from the user regarding the relevance of the alarm on a numerical scale. Thus, the relevance indicator may be a binary indication (relevant or not relevant), a numerical value (indicating a relevance value), a category, or other inputs as described below. The medical device receives this feedback and stores the relevance indicator along with information about the alarm event, such as the alarm condition, the medical device status, and the patient's physiological status. Together, this relevance event data is then further analyzed to identify alarm protocols that have low relevance, and to modify those alarm protocols or to create new alarm protocols that decrease the prevalence of nuisance alarms. – non-authentic is a low relevance alarm and the bespoke monitoring parameter is the determining a nuisance alarm); and
defining the incident as having occurred if the plurality of detected alarms includes the plurality of required alarms (paragraph 0025 - An alarm is generated by a medical device (such as the monitor 12 or a therapeutic device, such as a ventilator) when an alarm condition or protocol is met. Alarm conditions include several types, such as physiologic alarm conditions, patient event alarm conditions, and device alarm conditions…. Further, alarm conditions may be based on a combination of different alarm conditions, such as two physiologic parameters each violating a respective limit, a combined alarm index violating a limit, or specified combinations of monitor and sensor status events.; paragraph 0055 - In another embodiment, analysis of the collected relevance event data may reveal a relationship between two or more physiologic parameters, and modifying the alarm condition may include combining alarm conditions from two or more physiologic parameters. The new combined alarm is not triggered unless both (or all) conditions are met.).
Boyer fails to explicitly state processing one or more of the plurality of detected alarms to determine an authenticity of the one or more of the plurality of detected alarms, including defining one or more of: volatility information; bias information; and persistence information.
Boyer does disclose in paragraph 0025 - An alarm is generated by a medical device (such as the monitor 12 or a therapeutic device, such as a ventilator) when an alarm condition or protocol is met. Alarm conditions include several types, such as physiologic alarm conditions, patient event alarm conditions, and device alarm conditions.
Al-Ali does disclose processing one or more of the plurality of detected alarms to determine an authenticity of the one or more of the plurality of detected alarms, including defining one or more of: volatility information, wherein the volatility information includes a comparison of a variance of data signals from at least one of the plurality of medical devices over a first time period to a variance of the data signals from the at least one of the plurality of medical devices over a second timer period, the second time period being longer than the first time period; bias information; and persistence information in paragraph 0014 - Another aspect of an adaptive alarm system measures a physiological parameter, establishes a baseline for the parameter, adjusts an alarm threshold according to drift of the baseline and triggers an alarm in response to the parameter measurement crossing the alarm threshold. In various embodiments, the baseline is established by biasing a segment of the parameter, calculating a biased trend from the biased segment and restricting the transient response of the biased trend.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include alarm events being triggered based on the baseline is established by biasing a segment of the parameter, calculating a biased trend from the biased segment and restricting the transient response of the biased trend of Al-Ali in the physiological alarm conditions in Boyer. A person of ordinary skill in the art would have been motivated to make the modification because alarm events are determined based on the baseline and its drift, as disclosed in paragraph 0014.
Boyer and Al-Ali fail to explicitly state generating a graphical representation of a level at which the threshold is current being exceeded and a representation of a level at which the adjusted threshold would be exceeded.
Boyer does disclose in paragraph 0023 - The display 16 may also display information related to alarms, monitor settings, and/or signal quality. In certain embodiments, the display 16 may be a touch screen display.
Treacy et al. discloses generating a graphical representation of a level at which the threshold is current being exceeded and a representation of a level at which the adjusted threshold would be exceeded in paragraph 0048 - In an exemplary embodiment, two alarms are associated with the heart rate physiological data. Specifically, a low heart rate limit 186 and a high heart rate limit 188. The current heart rate alarm limit values associated with these alarms are visually presented on the histogram 182 in relation to the histogram relating the associated physiological data of the patient for the particular parameter alarm (heart rate) being considered. The user is able to use this GUI 180 to test prospective new limits for the parameter alarms by entering new threshold values in the user interface 190. By selecting the update histogram button the user interface 190, the histogram 182 can update to graphically depict the prospective low heart rate alarm value 192 which is exemplarily 40 beats per minute and to reflect the proposed high heart rate alarm value 194 which exemplarily is proposed to be adjusted to 155 beats per minute. By making such an adjustment, the prospective analysis portion 184 is updated in a prospective reporting section 196 to indicate the proposed new alarm limit values.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a GUI displaying low heart rate limit, a high heart rate limit, and current hear rate alarm limit values of Treacy in displaying information relating to alarms and other information of Boyer. A person of ordinary skill in the art would have been motivated to make the modification because identifying and implementing interventions to address alarm burden require monitoring, visualization, and analysis tools in order to assist clinicians and/or clinical managers in making and implementing such decisions, as disclosed in paragraph 0019.
Response to Arguments
Applicant’s arguments and amendments with respect to claims 1-9,11-20,22-30 have been fully considered. Concerning the arguments of the 101 rejection, the newly added limitations do not overcome the rejection. Please see the above rejection. Concerning the arguments of the 103 rejection, new references have been added to reject limitations. Please see the above rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yolanda L Wilson whose telephone number is (571)272-3653. The examiner can normally be reached M-F (7:30 am - 4 pm).
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/Yolanda L Wilson/Primary Examiner, Art Unit 2113