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 .
Priority
Applicant’s claim for the benefit of a prior-filed application (U.S. Appl. No. 18/323,158) under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged, and properly constitutes a continuation-in-part of the prior application. As such, acknowledgement is made of Applicant' s claim for priority to 01 August 2023.
Response to Amendment
Claims 1-9 were previously pending in this application. The amendment filed 17 November 2025 has been entered and the following has occurred: Claim 1 have been amended. Claims 10-13 have been added. No claims have been cancelled.
Claims 1-13 remain pending in the application .
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 1-13 rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The claims recite subject matter within a statutory category as a machine (claims 1-13) which recite steps of:
obtain a time series of patient data samples;
receive one or more threshold values;
receive a delay value;
compare said patient data samples in real-time to said one or more threshold values;
when said patient data samples are consecutively outside said one or more threshold values for a time greater than said delay value, generate an alarm; and
transmit alarm data to said first processor, wherein
said alarm data comprises said patient data samples while said alarm is active;
generate an alarm summary record associated with said alarm data and store said alarm summary record in said database, wherein said alarm summary record comprises:
said alarm;
an alarm start time;
an alarm duration; and
a first value of said patient data samples of said alarm data; and,
retrieve alarm summary records over a time period from said database;
calculate an expected change in a number of alarms over said time period as a function of a modified delay value based on said alarm summary records; and
automatically transmit the modified delay value to one or more of said patient monitoring devices and to iteratively update the modified delay value in said one or more of said patient monitoring devices through a closed-loop feedback control process that monitors alarm frequency and patient status, thereby reducing false alarm rate while maintaining patient safety threshold to avoid clinicians being unable to respond effectively
These steps of monitoring one or more patients on one or more patient monitoring devices, receiving one or more threshold values, transmitting an alarm when said patient data samples are outside said one or more threshold values, generating a record of one or more of the transmitted alarms and retrieving said alarm summary record and calculating an expected change in a number of alarms over a future time period based on said received alarm summary record, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. That is, the performance of the steps by the system effectively manages the typical behavior of medical staff regarding one or more patients that are being monitored under their care. For instance, said performance of the steps recited relates to human activity at least by monitoring one or more actions and/or physiological data of the patient and potentially generating an alarm and an associated alarm summary record for future management of said patient by the hospital staff. That is, the typical behavior of the hospital staff regarding the issuing of alarms is effectively managed by the system performing the steps recited. Further, while aspects of the threshold values are specified in the limitations found at the end of the claim, these aspects still fall in line with manages the typical behavior of medical staff regarding one or more patients that are being monitored under their care, but recited for specifically tailoring alarms to certain conditions. This is further supported by the dependent claims reciting actions relating to issuance of one or more alarms, such as editing one or more thresholds for alarm issuance in order to effect the change in a number of alarms over said future period of time. Accordingly, the claim recites an abstract idea.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2-13, reciting particular aspects of how determining a new threshold value, classifying an alarm summary record, performing various forms of analysis on said alarm summary record in view of patient physiological data, e.g. clustering analysis, generating a frequency distribution, and/or performing various analyses may be performed in the mind but for recitation of generic computer components).
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as recitation of a first/second processor, a database, a multiplicity of patient monitoring devices, amounts to invoking computers as a tool to perform the abstract idea, see Applicant’s Specification [0036] & [0038] for a first/second processor; [0038] for a database; [0031]-[0032] for a multiplicity of patient monitoring devices; see MPEP 2106.05(f));
add insignificant extra-solution activity to the abstract idea (such as recitation of obtaining a time series of patient data samples, receive one or more threshold values, receive a delay value, transmit alarm data, retrieve alarm summary records over a time period from said database, transmitting the modified delay value to one or more patient monitoring devices amounts to mere data gathering efforts; recitation of specifying the alarm data comprising patient data samples while said alarm is active, specifying the alarm summary record comprising said alarm, alarm start time, alarm duration, and a first value of said patient data samples of said alarm data, comparing said patient data samples in real-time to said one or more threshold values amounts to selecting a particular data source or type of data to be manipulated; recitation of generating an alarm, generating an alarm summary record, storing the alarm summary record in a database, calculating an expected change in a number of alarms over said time period as a function of a modified delay based on said alarm summary records, comparing patient data samples to one or more threshold values, forming a closed-loop feedback control process to update modified delay values in patient monitoring devices amounts to insignificant application, see MPEP 2106.05(g));
generally link the abstract idea to a particular technological environment or field of use (such as recitation of the steps recited for patient monitoring, such as in clinical setting, see MPEP 2106.05(h)).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2-13, which recite limitations relating to a second processor, patient monitoring devices, a database, additional limitations which amount to invoking computers as a tool to perform the abstract idea, see Applicant’s Specification [0036] & [0038] for a second processor; [0031]-[0032] for a multiplicity of patient monitoring devices [0038] for a database, see MPEP 2106.05(f); ); claims 2 & 11, which recites limitations relating to transmitting delay values to one or more said multiplicity of patient monitoring devices to replace said delay value, additional limitations which add insignificant extra-solution activity to the abstract idea which amounts to mere data gathering; claims 3-9, which recite limitations relating to setting alarm parameters/delays, additional limitations which add insignificant extra-solution activity to the abstract idea by selecting a particular data source or type of data to be manipulated; claims 3-9 & 12-13, which recite limitations relating to calculating varying aspects of the alarm parameters/delays, such as an expected change in number of alarms over a time period, calculating an expected increase in alarms over a time period, calculating a frequency distribution of event durations, extrapolating said curve to event durations less than or equal to the delay value, calculating a geometric distribution, estimating a delay value, estimating a curve relating an average value of patient data sample, calculating standard deviation and/or variance of patient data samples to form a computer statistical descriptor, analyzing correlations between the computer statistical descriptor and said alarm duration over time, additional limitations which amount to insignificant application, additional limitations which generally link the abstract idea to a particular technological environment or field of use). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as obtaining a time series of patient data samples, receive one or more threshold values, receive a delay value, transmit alarm data, retrieve alarm summary records over a time period from said database, transmitting modified delay values to one or more patient monitoring devices, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); generating an alarm, generating an alarm summary record corresponding to one or more generated alarms, calculating an expected change in a number of alarms over said time period as a function of a modified delay based on said alarm summary records, calculating a modified delay value based on monitored alarm frequency and patient status, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii); maintaining one or more alarm parameters and/or alarm summary records associated therewith, updating and/or maintaining modified delay values for patient monitoring devices, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii); storing one or more alarm parameters in an alarm summary record, storing the associated alarm summary record in a database, storing computerized instructions to perform the steps recited, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv); analyzing/extracting data from alarm summary records for calculation of expected change in a number of alarms, which under BRI includes electronic scanning or parsing, e.g., electronic scanning or extracting data from a physical document, Content Extraction, MPEP 2106.05(d)(II)(v); forming a closed-loop feedback control process to update modified delay values in patient monitoring devices, see Dyell Par [0097]-[0099] which discloses employing a closed-loop control system, such that the system can be configured to account for any hysteresis of its feedback loop, where hysteresis indicates a dependence of the output of system on its current input and its history of past inputs, i.e. outputs/behavior of the system forms a closed-loop system to iteratively adjust the system to prevent alarm fatigue, as specifically mentioned in Dyell Par [0095] & [0097], such that based on monitored trends, etc. in available data may trigger shifts in how alarms are to be outputted for corresponding devices; utilizing closed loop algorithms in a medical monitoring environment, see Beck Par [0332] which discloses a closed loop control algorithm being employed to control one or more user-set or user- changed parameter settings, such as corresponding to presented alerts or alarms for ventilation systems).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2-13, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields; claims 2 & 11, which recites limitations relating to transmitting delay values to one or more said multiplicity of patient monitoring devices to replace said delay value, receiving alarm data that comprises unique event identifier while said alarm is active, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); claims 3-9 & 12-13, which recite limitations relating to calculating varying aspects of the alarm parameters/delays, such as an expected change in number of alarms over a time period, calculating an expected increase in alarms over a time period, calculating a frequency distribution of event durations, extrapolating said curve to event durations less than or equal to the delay value, calculating a geometric distribution, estimating a delay value, estimating a curve relating an average value of patient data sample, calculating standard deviation and/or variance of patient data samples to form a computer statistical descriptor, analyzing correlations between the computer statistical descriptor and said alarm duration over time, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii); claims 2-10 & 12, which generally recite limitations relating to determining and maintaining one or more alarm parameters and a record thereof such as maintaining one or more alarm summary records comprising various data/information, tagging or assigning an event identifier to an alarm, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii); claims 2-13, which generally recite limitations relating to determining and maintaining one or more alarm parameters and a record thereof and storage of said parameters, storing computerized instructions for performance, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv)). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6 & 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over De Waele et al. (U.S. Patent Publication No. 2016/0051206), hereinafter “De Waele”, in view of Dyell et al. (U.S. Patent Publication No. 2023/0363678), hereinafter “Dyell”.
Claim 1 –
Regarding Claim 1, De Waele discloses a system that efficiently calculates and sets alarm delays for patient monitoring devices comprising:
a data collection system comprising a first processor coupled to a database and communicatively coupled to a multiplicity of patient monitoring devices (See De Waele Par [0020] which discloses one or more medical monitors which receive vital sign signal values from monitored patients, such as a non-invasive or invasive blood pressure (BP) monitor, SpO2 or blood oximetry device, respiratory rate (RR) monitor, electrocardiogram (ECG) monitor, Heart Rate (HR) monitor and the like; See De Waele Par [0028]-[0029] & Fig .1 which disclose the system containing one or more processing devices and/or connected databases, data structures, non-transitory computer readable media, etc., for storing alarm settings or alarm profiles, the suggested profiles, the monitor log, the central log, the normative settings, the normative vital sign signals, and the patient data), wherein
each patient monitoring device of said multiplicity of patient monitoring devices is configured to:
obtain a time series of patient data samples (See De Waele Par [0020] which discloses one or more medical monitors which receive vital sign signal values from monitored patients, such as a non-invasive or invasive blood pressure (BP) monitor, SpO2 or blood oximetry device, respiratory rate (RR) monitor, electrocardiogram (ECG) monitor, Heart Rate (HR) monitor and the like; See De Waele Par [0007] which discloses alarm settings including at least one of an upper limit and a lower limit, i.e. value, for at least one monitored vital sign);
receive one or more threshold values (See De Waele Par [0002] which discloses one or more minimum and/or maximum threshold limit values; See De Waele Par [0021] which discloses receiving one or more alarm setting such as one or more upper and/or lower limit, i.e. threshold, values for a vital signal);
receive a delay value (See De Waele Par [0032] which discloses that alarm settings/parameters can include limits, an alarm delay, or inhibition time, switching an alarm on or off, or changing alarms severity);
compare said patient data samples in real-time to said one or more threshold values (See De Waele Par [0002] which discloses comparing vital signs from one or more patients and sending alerts if one or more vital signs exceeds of falls to a predetermined threshold value, i.e. comparing patient vital signs to one or more threshold values for issuance of an alert, albeit not in real-time);
when said patient data samples are consecutively outside said one or more threshold values for a time greater than said delay value, generate an alarm (See De Waele Par [0002] which discloses one or more minimum and/or maximum threshold limit values, and upon exceeding one or more of the threshold limit values, sending an alert/generating an alarm; See De Waele Par [0021] which discloses receiving one or more alarm setting such as one or more upper and/or lower limit, i.e. threshold, values for a vital signal); and
transmit alarm data to said first processor (See De Waele Par [0023] which discloses a monitor log including alarm settings at an alarm event, alarm setting change history, etc., constituting alarm data), wherein
said alarm data comprises said patient data samples while said alarm is active (See De Waele Par [0023] which discloses including a vital sign signal history and/or vital sign signals according to alarm events or other time intervals);
said first processor is configured to:
generate an alarm summary record associated with said alarm data and store said alarm summary record in said database (See De Waele Par [0023] which discloses a monitor log, i.e. alarm summary record, including alarm settings at an alarm event, alarm setting change history, etc., constituting alarm data and is stored by the medical monitoring unit which can then possibly be received by a central log), wherein said alarm summary record comprises:
said alarm (See De Waele Par [0023] which discloses a monitor log, i.e. alarm summary record, including alarm settings at an alarm event, alarm setting change history, etc., constituting alarm data);
an alarm start time (See De Waele Par [0038] which discloses the system identifying a time interval, either a minimum or a maximum after which a different alarm setting value is recommended, and would thereby constitute an “alarm start time” under BRI because this represents a time segment, i.e. start time to end time, that a certain alarm parameter is used);
an alarm duration (See De Waele Par [0038] which discloses the system identifying a time interval, either a minimum or a maximum after which a different alarm setting value is recommended, and would thereby constitute an “alarm duration” under BRI because this represents a duration of time that a certain alarm parameter is used); and
a first value of said patient data samples of said alarm data (See De Waele Par [0007] which discloses alarm settings including at least one of an upper limit and a lower limit, i.e. value, for at least one monitored vital sign); and,
an alarm analysis system comprising a second processor coupled to said database (See De Waele Par [0028]-[0029] & Fig .1 which disclose the system containing one or more processing devices and/or connected databases, data structures, non-transitory computer readable media, etc., for storing alarm settings or alarm profiles, the suggested profiles, the monitor log, the central log, the normative settings, the normative vital sign signals, and the patient data), wherein said second processor is configured to:
retrieve alarm summary records over a time period from said database (See De Waele Par [0023] which discloses a monitor log, i.e. alarm summary record, including alarm settings at an alarm event, alarm setting change history, etc., constituting alarm data and is stored by the medical monitoring unit which can then possibly be received by a central log);
calculate an expected change in a number of alarms over said time period of a modified delay value based on said alarm summary records (See De Waele Par [0038] which discloses the system identifying a time interval, either a minimum or a maximum after which a different alarm setting value is recommended, such that after a predetermined time interval or function thereof is satisfied, a second alarm setting is recommended based on certain variables, including alarm counts, i.e. number of alarms over said time period; See De Waele Par [0032] which discloses that alarm settings/parameters can include limits, an alarm delay, or inhibition time, switching an alarm on or off, or changing alarms severity);
automatically transmit the modified delay value to one or more of said patient monitoring devices and to iteratively update the modified delay value in said one or more of said patient monitoring devices through a closed-loop feedback control process that monitors alarm frequency and patient status, thereby reducing false alarm rate while maintaining patient safety threshold to avoid clinicians being unable to respond effectively (It is understood that the language” thereby reducing false alarm rate…” is a "whereby clause that simply expresses the intended result of a process step positively recited, and therefore does not grant patentable weight for prior art analysis; See De Waele Par [0026] which discloses updating the alarm settings based on suggested profiles and/or analysis performed, albeit not automatically by the system itself; See De Waele Fig. 6 which discloses a loop of measuring deviations from one or more alarm/alert policies and making recommendation/modifications to said alarm/alert policies in a loop-wise fashion to iteratively update said parameters, including those parameters found in De Waele Par [0032] which discloses that alarm settings/parameters can include limits, an alarm delay, or inhibition time, switching an alarm on or off, or changing alarms severity, albeit not via iteratively updating through a closed-loop feedback control process of the system itself).
While De Waele generally discloses updating or modifying alarm settings, i.e. delay value, by electronic transmission, such as to reduce the number of alarms generated, De Waele is generally silent regarding determining/calculating an expected change in a number of alarms over said time period as a function of a modified delay value based on said alarm summary records and/or automatically transmitting the determined modified delay value that De Waele generates, such as in a closed-loop iterative fashion to modify said delay values over time by the system itself, as given by the following limitation:
compare said patient data samples in real-time;
calculate an expected change in a number of alarms over said time period as a function of a modified delay value based on said alarm summary records;
automatically transmit the modified delay value to one or more of said patient monitoring devices and to iteratively update the modified delay value in said one or more of said patient monitoring devices through a closed-loop feedback control process that monitors alarm frequency and patient status
However, Dyell discloses compare said patient data samples in real-time (See Dyell Par [0097] which discloses the alarm management system operating in real-time; See Dyell Par [0097]-[0099] and claim 7 which discloses the real-time data and/or trends calculated include changes in alarm data, or other types of data include physiological data and/or physiological parameters, and/or physiological status of one or more users or patients), calculate an expected change in a number of alarms over said time period as a function of a modified delay value based on said alarm summary records (See Dyell Par [0096]-[0099] which discloses the system monitoring trends in available data in order to trigger shifts in how alarms are presented, such that a fatigue model can be generated using a feedback loop, for example, as a user experiences more and more alarms throughout a shift (i.e. a desired time period), that user's alarm fatigue rises, and therefore, the systems sensing and quantifying a rise in alarm fatigue level automatically modulates, i.e. modifies, alarm outputs/conditions to mitigate effects of the user’s alarm fatigue; See Dyell Par [0099] further specifies that frames of reference, e.g. desired time period, can span hours, days, weeks, months, and/or years) and automatically transmit the modified delay value to one or more of said patient monitoring devices and to iteratively update the modified delay value in said one or more of said patient monitoring devices through a closed-loop feedback control process that monitors alarm frequency and patient status (see Dyell Par [0097]-[0099] which discloses employing a closed-loop control system, such that the system can be configured to account for any hysteresis of its feedback loop, where hysteresis indicates a dependence of the output of system on its current input and its history of past inputs, i.e. outputs/behavior of the system forms a closed-loop system to iteratively adjust the system to prevent alarm fatigue, as specifically mentioned in Dyell Par [0095] & [0097], such that based on monitored trends, etc. in available data may trigger shifts in how alarms are to be outputted for corresponding devices; See Dyell Par [0089]-[0093] specifically mentions considerations of particular medical devices that may be more prone to issuing excessive alarms because a threshold condition is too low, or has varying measurement sensitivities, such that the system can determine potential alarm conditions and consider a measurement sensitivity to determine a minimum amount of change a physiological measurement undergoes before the medical device detects the change for triggering alarms to reduce unnecessary alarm generation, such as by determining when fewer or greater alarms would be issued, and specifically recites if a medical device is set to detect body temperature changes only when the temperature change is 0.2 degrees or greater, fewer alarms would be generated based on small fluctuations around the threshold value, and thereby also establishes a functional relationship between potential modifications of said devices and a resulting number of alarms from said modifications based, for instance, measurement sensitivity; See Dyell Par [0078] & [0092]-[0093] which discloses system components, i.e. automatically and without manual input, implementing or changing alarms and/or types of alarms based on alarm condition and this having a direct effect on how frequently the medical device generates alarms, such as potentially reducing the number of alarms). The disclosure of Dyell is directly applicable to the disclosure of De Waele because both disclosures share limitations and capabilities, such as being directed towards modifying and monitoring one or more alarm/alert parameters.
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 disclosure of De Waele which discloses updating or modifying alarm settings in real-time, particularly alarm delay, by electronic transmission, such as to reduce the number of alarms generated to further include calculating an expected change in a number of alarms over said time period as a function of a modified delay value based on said alarm summary records, as disclosed by Dyell, because this allows for an automatic fatigue model to be generated, such that a system can automatically modulate, i.e. modify, the alarm outputs to a user to mitigate effects of the user’s alarm fatigue in real-time (See Dyell Par [0096]-[0099]). It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the disclosure of De Waele which discloses updating or modifying alarm settings, particularly alarm delay, by electronic transmission to further include automatically implementing said alarm settings and/or transmission of said alarm settings, as disclosed by Dyell, because this allows for an automatic fatigue model to be generated using a feedback loop, such that a system can automatically modulate, i.e. modify, the alarm outputs to that user to mitigate effects of the user’s alarm fatigue (See Dyell Par [0096]-[0099]).
Claim 2 –
Regarding Claim 2, De Waele and Dyell discloses the system of claim 1 in its entirety. De Waele further discloses as system, wherein:
said second processor is further configured to:
determine a new delay value (See De Waele Par [0038] which discloses the system identifying a time interval, either a minimum or a maximum after which a different alarm setting value is recommended, such that after a predetermined time interval or function thereof is satisfied, a second alarm setting is recommended based on certain variables, including alarm counts, i.e. number of alarms over said time period; See De Waele Par [0032] which discloses that alarm settings/parameters can include limits, an alarm delay, or inhibition time, switching an alarm on or off, or changing alarms severity); and
transmit said new delay value to one or more of said multiplicity of patient monitoring devices to replace said delay value (See De Waele Par [0022] which discloses a setting manager configured to receive changes, i.e. new or updated values, to alarm settings by electronic transmission from a suggested profile data store; See De Waele Par [0027] which discloses the observational analyzer recommending changes to alarms settings for the patient based on current vital sign data and/or alarm data, and sends the recommended changes to the alerting device or other computing device; See De Waele Par [0032] which discloses that alarm settings/parameters can include limits, an alarm delay, or inhibition time, switching an alarm on or off, or changing alarms severity).
Claim 3 –
Regarding Claim 3, De Waele and Dyell disclose the system of claim 2 in its entirety. De Waele further discloses as system, wherein:
said second processor is further configured to:
determine said new delay value as said modified delay value that results in a target value of said expected change in said number of alarms over said period See De Waele Par [0038] which discloses the system identifying a time interval, either a minimum or a maximum after which a different alarm setting value is recommended, such that after a predetermined time interval or function thereof is satisfied, a second alarm setting is recommended based on certain variables, including alarm counts, i.e. number of alarms over said time period; See De Waele Par [0032] which discloses that alarm settings/parameters can include limits, an alarm delay, or inhibition time, switching an alarm on or off, or changing alarms severity).
Claim 4 –
Regarding Claim 4, De Waele and Dyell disclose the system of claim 1 in its entirety. De Waele further discloses as system, wherein:
said calculate said expected change in said number of alarms over said time period comprises:
when said modified delay value is greater than said delay value by an increase delay amount, calculate said expected change in said number of alarms over said time period as a decrease equal to a number of said alarm summary records having said alarm duration less than or equal to said increase delay amount (Under broadest reasonable interpretation, contingent limitations require only those steps that must be performed and does not have to include steps that are not required to be performed because conditions precedent are not met; however, the BRI of a system claim having structure that performs a function that is conditional, at least requires the structure for performing the function should the condition occur, but still does not have to teach said function, see MPEP 2111.04(II); therefore, De Waele Par [0028]-[0029] & Fig. 1 disclosing the system containing one or more processing devices and/or connected databases, data structures, non-transitory computer readable media, etc., for storing and managing storage of alarm settings or alarm profiles, the suggested profiles, the monitor log, the central log, the normative settings, the normative vital sign signals, and the patient data and for editing or modifying threshold values effectively reads on the limitation herein because the conditions of “when said modified delay value is greater than said delay value by an increase delay amount” does not have to ever necessarily be met under BRI, because all of the modified threshold values could correspond to a lower threshold).
Claim 5 –
Regarding Claim 5, De Waele and Dyell disclose the system of claim 4 in its entirety. De Waele further discloses as system, wherein:
said second processor is further configured to:
calculate an expected increase in said number of alarms over said time period when modified delay value is smaller than said delay value (See De Waele Par [0038] which discloses the system identifying a time interval, either a minimum or a maximum after which a different alarm setting value is recommended, such that after a predetermined time interval or function thereof is satisfied, a second alarm setting is recommended based on certain variables, including alarm counts, i.e. number of alarms over said time period and therefore if the number of alarms is more would constitute an “increase”; See De Waele Par [0032] which discloses that alarm settings/parameters can include limits, an alarm delay, or inhibition time, switching an alarm on or off, or changing alarms severity).
Claim 6 –
Regarding Claim 6, De Waele and Dyell disclose the system of claim 5 in its entirety. De Waele and Dyell further discloses as system, wherein:
said calculate said expected increase in said number of alarms over said time period comprises
calculate a frequency distribution of event durations of alarm summary records in said database, wherein an event duration associated with an alarm summary record comprises said alarm duration added to said delay value (See De Waele Par [0033]-[0034] & Fig. 3 which discloses a correlation plot and/or cluster analysis of two alarm settings or limits, such that a first alarm limit and second alarm limit are represented and dots are sized to represent the frequency of occurrence in the analyzed monitor logs or extracted normative settings and/or normative vital sign signals, i.e. first and second frequency distributions for each alarm setting/parameter; See De Waele Par [0032] which discloses that alarm settings/parameters can include limits, an alarm delay, or inhibition time, switching an alarm on or off, or changing alarms severity);
fit a curve to said frequency distribution of event durations (See De Waele Par [0033]-[0034] & Fig. 3 which discloses a correlation plot and/or cluster analysis of two alarm settings or limits, such that a first alarm limit and second alarm limit are represented and dots are sized to represent the frequency of occurrence in the analyzed monitor logs or extracted normative settings and/or normative vital sign signals, i.e. first and second frequency distributions for each alarm setting/parameter; See De Waele Par [0032] which discloses that alarm settings/parameters can include limits, an alarm delay, or inhibition time, switching an alarm on or off, or changing alarms severity; See De Waele Par [0030]-[0031] which discloses performing regression analysis, i.e. curve fitting, on a correlation plot as in De Waele Par [0033]-[0034] to extrapolate alarm settings);
extrapolate said curve to event durations less than or equal to said delay value (See De Waele Par [0030]-[0031] which discloses performing regression analysis, i.e. curve fitting, on a correlation plot as in De Waele Par [0033]-[0034] to extrapolate alarm settings; See De Waele Par [0032] which discloses that alarm settings/parameters can include limits, an alarm delay, or inhibition time, switching an alarm on or off, or changing alarms severity); and,
calculate said expected increase in said number of alarms over said time period as a sum of values of said curve for event durations greater than said modified delay value and less than or equal to said delay value (See De Waele Par [0033]-[0034] & Fig. 3 which discloses a correlation plot and/or cluster analysis of two alarm settings or limits, such that a first alarm limit and second alarm limit are represented and dots are sized to represent the frequency of occurrence in the analyzed monitor logs or extracted normative settings and/or normative vital sign signals, i.e. frequency distribution, such that a representative or center value of each cluster is computed as an alarm setting value in one or more suggested profiles; See De Waele Par [0032] which discloses that alarm settings/parameters can include limits, an alarm delay, or inhibition time, switching an alarm on or off, or changing alarms severity; See Dyell Par [0096]-[0099] which discloses the system monitoring trends in available data in order to trigger shifts in how alarms are presented, such that a fatigue model can be generated using a feedback loop, for example, as a user experiences more and more alarms throughout a shift (i.e. a desired time period), that user's alarm fatigue rises, and therefore, the systems sensing and quantifying a rise in alarm fatigue level automatically modulates, i.e. modifies, alarm outputs/conditions to mitigate effects of the user’s alarm fatigue; See Dyell Par [0099] further specifies that frames of reference, e.g. desired time period, can span hours, days, weeks, months, and/or years).
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 disclosure of De Waele which discloses updating or modifying alarm settings, particularly alarm delay, by electronic transmission, such as to reduce the number of alarms generated to further include calculating an expected change in a number of alarms over said time period as a function of a modified delay value based on said alarm summary records, as disclosed by Dyell, because this allows for an automatic fatigue model to be generated, such that a system can automatically modulate, i.e. modify, the alarm outputs to a user to mitigate effects of the user’s alarm fatigue (See Dyell Par [0096]-[0099]).
Claim 8 –
Regarding Claim 8, De Waele and Dyell disclose the system of claim 1 in its entirety. De Waele further discloses as system, wherein:
said second processor is further configured to:
estimate said delay value (See De Waele Par [0038] which discloses the system identifying a time interval, either a minimum or a maximum after which a different alarm setting value is recommended, such that after a predetermined time interval or function thereof is satisfied, a second alarm setting is recommended based on certain variables, including alarm counts, i.e. number of alarms over said time period; See De Waele Par [0032] which discloses that alarm settings/parameters can include limits, an alarm delay, or inhibition time, switching an alarm on or off, or changing alarms severity).
Claim 9 –
Regarding Claim 9, De Waele and Dyell disclose the system of claim 8 in its entirety. De Waele and Dyell further discloses as system, wherein:
said estimate said delay value comprises:
estimate a curve relating an average value of a patient data sample to a number of samples prior to and including said patient data sample that have been consecutively outside said one or more threshold values (See De Waele Par [0038] which discloses the system identifying a time interval, either a minimum or a maximum after which a different alarm setting value is recommended, such that after a predetermined time interval or function thereof is satisfied, a second alarm setting is recommended based on certain variables, including alarm counts, i.e. number of alarms over said time period; See De Waele Par [0032] which discloses that alarm settings/parameters can include limits, an alarm delay, or inhibition time, switching an alarm on or off, or changing alarms severity; See De Waele Par [0030]-[0031] which discloses performing regression analysis, i.e. curve fitting, on a correlation plot as in De Waele Par [0033]-[0034] to extrapolate alarm settings); and,
estimate said delay value as said number of samples prior to and including said patient data sample that correspond on said curve to an average first value of alarm summary records in said database (See De Waele Par [0033]-[0034] & Fig. 3 which discloses a correlation plot and/or cluster analysis of two alarm settings or limits, such that a first alarm limit and second alarm limit are represented and dots are sized to represent the frequency of occurrence in the analyzed monitor logs or extracted normative settings and/or normative vital sign signals, i.e. frequency distribution, such that a representative or center value of each cluster is computed as an alarm setting value in one or more suggested profiles; See De Waele Par [0032] which discloses that alarm settings/parameters can include limits, an alarm delay, or inhibition time, switching an alarm on or off, or changing alarms severity; See Dyell Par [0096]-[0099] which discloses the system monitoring trends in available data in order to trigger shifts in how alarms are presented, such that a fatigue model can be generated using a feedback loop, for example, as a user experiences more and more alarms throughout a shift (i.e. a desired time period), that user's alarm fatigue rises, and therefore, the systems sensing and quantifying a rise in alarm fatigue level automatically modulates, i.e. modifies, alarm outputs/conditions to mitigate effects of the user’s alarm fatigue; See Dyell Par [0099] further specifies that frames of reference, e.g. desired time period, can span hours, days, weeks, months, and/or years; See De Waele Par [0030]-[0031] which discloses performing regression analysis, i.e. curve fitting, on a correlation plot as in De Waele Par [0033]-[0034] to extrapolate alarm settings).
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 disclosure of De Waele which discloses updating or modifying alarm settings, particularly alarm delay, by electronic transmission, such as to reduce the number of alarms generated to further include calculating an expected change in a number of alarms over said time period as a function of a modified delay value based on said alarm summary records, as disclosed by Dyell, because this allows for an automatic fatigue model to be generated, such that a system can automatically modulate, i.e. modify, the alarm outputs to a user to mitigate effects of the user’s alarm fatigue (See Dyell Par [0096]-[0099]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over De Waele in view of Dyell, further in view of Michelson et al. (U.S. Patent Publication No. 2014/0046683), hereinafter “Michelson”.
Claim 7 –
Regarding Claim 7, De Waele and Dyell disclose the system of claim 6 in its entirety. However, De Waele and Dyell do not further disclose a system, wherein:
said curve comprises a geometric distribution.
While De Waele and Dyell effectively discloses generating a frequency distribution and fitting a curve to said frequency distribution of event durations for optimizing alarms settings, De Waele and Dyell do not specifically disclose said curve comprising a geometric distribution.
However, Michelson discloses said curve comprises a geometric distribution (See Michelson Par [0097]-[0100] discloses a statical estimation method of applying a best fitting curve to convert plurality of distance metrics into a plurality of probabilities for subject data, such that the data is input into the mathematical model and its geometrical position within the probability space is determined, constituting a geometric distribution). The disclosure of Michelson is directly applicable to the combined disclosure of De Waele and Dyell, because the disclosures share limitations and capabilities, such as being directed towards improving patient outcomes by optimizing one or more clinical parameters.
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 combined disclosure of De Waele and Dyell which already discloses generating a frequency distribution and fitting a curve to said frequency distribution of event durations for optimizing alarms settings to further include utilizing a geometric distribution as the best fit curve, as disclosed by Michelson, because this allows for the calculation of a distance metric in the geometric distribution, i.e. Mahalanobis distance, for determining correlation between data points and inputting said determinations into a model space to optimize clinical parameters/outcomes (see Michelson Par [0097]-[0099]).
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over De Waele in view of Dyell, further in view of Joshi et al. (U.S. Patent Publication No. 2022/0044548), hereinafter “Joshi”.
Claim 10 –
Regarding Claim 10, De Waele and Dyell the system of claim 1 in its entirety. De Waele further discloses a system, wherein:
said alarm is tagged with a unique event identifier (While not a “unique event identifier” per se, see De Waele Par [0021]-[0023] which discloses a monitor log that includes a vital sign history, an alarm setting change history, and/or alarm settings at an alarm event, and/or vital sign signals according to alarm events or other time intervals, and can further include data elements including “a label, a delay, a severity, and/or a validity indicator”, i.e. an “identifier” for said alarm event under BRI).
While De Waele discloses data elements constituting an identifier for one or more alarm events as discussed above, De Waele does not explicitly mention said data elements being “unique” to an event and therefore does not read on a “unique event identifier” per se.
However, Joshi discloses said alarm is tagged with a unique event identifier (See Joshi Par [0210]-[0212] which discloses determining/predicting the occurrence of a critical alarm following a non-critical alarm using different features, including a (derived) value of the monitored physiological parameters of the subject(s), subject metadata and/or alarm information, such that features of a non-critical alarm information family could comprise an identifier, such as an identifier of the physiological parameter associated with the alarm, an indicator of the type of alarm, metadata, information on the category of the non-critical alarm generated, information on other alarms in the pre-alarm time window, values representing the heart rate, etc., such that it is understood that the combinations of these features would constitutes a “unique” event identifier to the specified alarm event occurring). The disclosure of Joshi is directly applicable to the combined disclosure of De Waele and Dyell, because the disclosures share limitations and capabilities, such as being directed towards monitoring and analysis of alarms for optimizing alarm settings over time.
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 disclosure of De Waele and Dyell, which already discloses tagging an alarm with an identifier for one or more alarm events as discussed above, to further include said identifier being unique to each event, as disclosed by Joshi, because this allows for identification of different features to be used when predicting the occurrence of critical alarm following a non-critical alarm (See Joshi Par [0210]).
Claim 11 –
Regarding Claim 11, De Waele, Dyell, and Joshi disclose the system of claim 10 in its entirety. De Waele and Joshi further discloses a system, wherein:
said alarm data further comprises said unique event identifier while said alarm is active (While not a “unique event identifier” per se, see De Waele Par [0021]-[0023] which discloses a monitor log that includes a vital sign history, an alarm setting change history, and/or alarm settings at an alarm event, and/or vital sign signals according to alarm events or other time intervals, and can further include data elements including “a label, a delay, a severity, and/or a validity indicator”, i.e. an “identifier” for said alarm event under BRI; See Joshi Par [0210]-[0212] which discloses determining/predicting the occurrence of a critical alarm following a non-critical alarm using different features, including a (derived) value of the monitored physiological parameters of the subject(s), subject metadata and/or alarm information, such that features of a ‘non-critical alarm information family could comprise an identifier, such as an identifier of the physiological parameter associated with the alarm, an indicator of the type of alarm, etc., during the alarm being active).
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 disclosure of De Waele and Dyell, which already discloses tagging an alarm with an identifier for one or more alarm events as discussed above, to further include said identifier being unique to each event, as disclosed by Joshi, because this allows for identification of different features to be used when predicting the occurrence of critical alarm following a non-critical alarm (See Joshi Par [0210]).
Claim 12 –
Regarding Claim 12, De Waele and Dyell the system of claim 1 in its entirety. De Waele and Joshi further discloses a system, wherein:
said alarm summary record further comprises a unique event identifier for said alarm and a computer statistical descriptor, including a variance or standard deviation, of said patient data samples associated with the unique event identifier of said alarm (See De Waele Claim 7 and Par [0041] & Fig. 6 which discloses the use of analysis of variance of the settings and/or vital sign signals, constituting the statistical descriptor found above, which can then be stored in one or more databases or profiles, el. 26 & 136 of Fig. 6, i.e. maintaining records of the alarm settings or profiles; See De Waele Par [0021] which discloses data elements in alarm settings for each vital sign including an identification of the vital sign, e.g. RR, HR, etc., one or more upper alarm limits and/or one or more lower alarm limits, such that the data elements include a label, a delay, a severity, and/or a validity indicator; See De Waele [0023] which discloses a monitor log, i.e. alarm summary record, including alarm settings at an alarm event, alarm setting change history, etc., and is stored by the medical monitoring unit which can then possibly be received by a central log and would therefore include the analysis of variance of the settings and/or vital sign signals described in De Waele Claim 7 and Par [0041] & Fig. 6 & the data elements in alarm settings for each vital signs, including a label, a delay, a severity, and/or a validity indicator being stored therein, such as in a record; See Joshi Par [0080]-[0083] which discloses envisaged statistical measures for patient data including standard deviation of the value of the physiological parameters within a predetermined and/or alarm time window, delta index, central tendency measures, approximate entropy, a coefficient of correlation, a root mean square, etc. to generate a predictive indicator indicating a probability that the non-critical alarm signal will be followed, within a post-alarm time window, by a critical alarm signal; See Joshi Par [0210]-[0212] which discloses determining/predicting the occurrence of a critical alarm following a non-critical alarm using different features, including a (derived) value of the monitored physiological parameters of the subject(s), subject metadata and/or alarm information, such that features of a ‘non-critical alarm information family could comprise an identifier, such as an identifier of the physiological parameter associated with the alarm, an indicator of the type of alarm, etc., during the alarm being active).
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 disclosure of De Waele and Dyell, which already discloses tagging an alarm with an identifier for one or more alarm events as discussed above, to further include said identifier being unique to each event and utilizing a variance or standard deviation of patient data samples, as disclosed by Joshi, because this allows for identification of different features to be used when predicting the occurrence of critical alarm following a non-critical alarm (See Joshi Par [0080] & [0210]).
Claim 13 –
Regarding Claim 13, De Waele, Dyell, and Joshi disclose the system of claim 12 in its entirety. De Waele and Joshi further disclose a system, wherein:
said processor is further configured to analyze correlations between the computer statistical descriptor and said alarm duration over time to determine whether alarms are transient or spurious (See De Waele Par [0038]-[0039] which discloses analyzing correlations between vital sign signal values, e.g. statistical with alarm setting values See Joshi Par [0210]-[0212] which discloses a system making determinations whether alarms are critical or non-critical; See Joshi Par [0017] which discloses an automated system may attend to a non-critical alarm unintentionally triggered by noise or clinical acceptable natural variations in a subject’s condition, and is therefore understood to read on “spurious” and/or “transient” alarms under BRI without further specifying said definitions; See Joshi Par [0080]-[0083] which discloses envisaged statistical measures for patient data including standard deviation of the value of the physiological parameters within a predetermined and/or alarm time window, delta index, central tendency measures, approximate entropy, a coefficient of correlation, a root mean square, etc. to generate a predictive indicator indicating a probability that the non-critical alarm signal will be followed, within a post-alarm time window, by a critical alarm signal; See Joshi Par [0210]-[0212] which discloses determining/predicting the occurrence of a critical alarm following a non-critical alarm using different features, including a (derived) value of the monitored physiological parameters of the subject(s), subject metadata and/or alarm information, such that features of a ‘non-critical alarm information family could comprise an identifier, such as an identifier of the physiological parameter associated with the alarm, an indicator of the type of alarm, etc., during the alarm being active; See Joshi Par [0086] which discloses utilizing machine learning to generate information about the type of predicted critical alarm, such as indicating the cause/correlation of an event relative to patient data samples, such as dangerously low heart rate, desaturation, etc.; ).
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 disclosure of De Waele and Dyell, which already discloses tagging an alarm with an identifier for one or more alarm events as discussed above, to further include said identifier being unique to each event and utilizing a variance or standard deviation of patient data samples, as disclosed by Joshi, because this allows for identification of different features to be used when predicting the occurrence of critical alarm following a non-critical alarm (See Joshi Par [0080] & [0210]).
Response to Arguments
Applicant's arguments filed 17 November 2025 have been fully considered but they are not persuasive:
Regarding 35 U.S.C. 101 rejections of claims 1-9, Applicant argues on p. 7-9 of Arguments/Remarks that the amendments as claimed in independent claim 1 adds concrete machine-level functionality and ties the method to a specific technological implementation (a feedback control loop in patient monitoring devices). Applicant further argues that as such, the amendments cannot be done with the human mind alone and is not merely a method of organizing human activity. Examiner respectfully disagrees with Applicant’s arguments. While Examiner agrees that certain additional limitations are recited that may not be performed reasonably in the human mind, merely applying a judicial exception utilizing generic computer components, such as merely automating updating of device parameter does not preclude the steps from effectively reciting an abstract idea under BRI, see MPEP 2106.04(a)(2)(III)(C). Furthermore, mere automation of manual steps/processes is not sufficient to show an improvement in computer-functionality, and as such, the claims would still be directed towards the recited abstract idea. Additionally, these considerations of being performed in the human mind does not necessarily preclude the claims from reciting methods of organizing human activity. That is, an automated or computer performing a method of organizing human activity still amounts to the recited abstraction, but for mere performance by computer components. Therefore, claims 1-9 remain rejected under 35 U.S.C. 101.
Regarding 35 U.S.C. 101 rejections of claims 1-9, Applicant argues on p. 9-10 of Arguments/Remarks that the amendments as claimed in independent claim 1 adds concrete machine-level functionality and ties the method to a specific technological implementation (a feedback control loop in patient monitoring devices). Applicant further argues the amendments therefore introduce a technical improvement and add concrete machine-level functionality and ties the method to a specific technological implementation via a feedback control loop in patient monitoring devices and further specifically argues in view of Thales Visionix v U.S. and McRO v Bandai. Applicant additionally argues that the claim amendments introduce a technical effect and ensure a practical application by defining a closed-loop control process, thereby minimizing false alarm rates and maintaining safety thresholds. Examiner respectfully disagrees with Applicant’s arguments. Examiner contends that automating, i.e. a feedback control loop, to iteratively update the modified delay value, reads as an improvement to the already-characterized abstraction rather than an improvement to the devices or field of art itself. That is, merely automatically transmitting alarm threshold parameters to multiple patient devices based on analysis (e.g. via a closed- loop system) that is automatically performed simply entails aspects of data gathering, data analysis/repetitive calculation, and transmission of data over a network to one or more devices, which are all abstract steps. An improvement to an abstraction still typically constitutes the abstraction itself. That is, the instant set of claims does not necessarily improve on shortcomings found in prior art systems or the technological components implementing the judicial exception at hand. Rather, the steps recited merely apply a judicial exception using one or more computer components to achieve a desired result or effect, i.e. a desired rate of alarms. It should be noted that a claim that merely generically recites an effect or result from any method by which it is accomplished is not directed to patent-eligible subject matter, because it merely states that the abstract idea should be applied to achieve a desired result, Internet Patents Corporation v. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. Cir. 2015), and in the instant set of claims “reducing false alarm rate” and “avoid[ing] clinicians being unable to respond effectively” without further specifying how the conditions of reducing said false alarm rate can be met and/or translates to clinicians being able to respond effectively reads as generically reciting an effect or result from any method by which it is accomplished. That is, while the claims generally recite the system being automated to adjust device parameters via transmission of said device parameters, Applicant does not define the conditions of how automatically implementing said aspects reduces false alarm rates so that one of ordinary skill in the art could effectively determine that the false alarm rate is somehow being reduced. Regarding Thales Visionix v. U.S. and McRO v. Bandai, these cases were upheld as patent-eligible when the claimed method improved a medical monitoring technology rather than merely applying math, however this does not seem to be the case/fact-pattern found in the instant set of claims. That is, the instant set of claims does not necessarily improve on shortcomings found in prior art systems or the technological components implementing the judicial exception at hand. Rather, the steps recited merely apply a judicial exception using one or more computer components to achieve a desired result or effect. While Applicant again argues in view of the automation and technical feedback control, Examiner contends that improved ways of transmitting data and performing analyses/calculations amounts to improved methods of collecting and structuring alarm data and/or performing repetitive calculations to derive a functional relationship and selecting a new delay value to be transmitted to one or more devices, even in an automated fashion, amounts to merely improved data gathering/data manipulation and repetitive calculation, therefore still constituting the abstraction itself. As such, the claims do not amount to a practical application and/or technological improvement in prior art systems. Therefore, claims 1-9 remain rejected under 35 U.S.C. 101.
Regarding 35 U.S.C. 103 rejections of claims 1-9, Applicant argues on p. 10-13 of Arguments/Remarks that the amendments to independent claim 1 overcome previous 35 U.S.C. 103 rejections made over De Waele in view of Dyell. More specifically, Applicant argues that previous portions of De Waele and Dyell do not disclose “automatically transmit the modified delay value… to respond effectively” because De Waele does not perform said aspects automatically or in a closed-loop fashion, and Dyell does not disclose transmission of modified delay values to the patient monitoring devices, because the feedback of Dyell pertains to the user interface, not to the device’s core operational parameters, i.e. hardware alarm logic of medical devices. Examiner agrees with Applicant’s arguments. Therefore, the 35 U.S.C. 103 rejections have been withdrawn. However, upon further consideration, a new ground of rejection is made in view of newly cited/reasoned portions of De Waele and Dyell. For instance, De Waele Par [0026] and De Waele Fig. 6 disclose a loop of measuring deviations from one or more alarm/alert policies and making recommendation/modifications to said alarm/alert policies in a loop-wise fashion to iteratively update said parameters, including those parameters found in De Waele Par [0032] which discloses that alarm settings/parameters can include limits, an alarm delay, or inhibition time, switching an alarm on or off, or changing alarms severity, albeit not via iteratively updating through a closed-loop feedback control process of the system itself. While Applicant argues that De Waele does not disclose the automated transmission of said aspects, such as in an automated, closed-loop logic fashion, because De Waele utilizes an open-loop configuration without iterative recalibration based on performance outcomes, this aspect is instead met by Dyell. That is, Dyell Par [0089]-[0095] & [0097]-[0099] discloses the use of closed-loop, iterative loop fashion updating of various parameters and automatically implementing changes to said alarm parameters. While Applicant argues that Dyell does not disclose transmission of modified delay values to the patient monitoring devices, this aspect is already met by De Waele, just not in an automated, closed-loop logic fashion, and therefore does not have to be met by Dyell. Therefore, claims 1-9 remain rejected under 35 U.S.C. 103.
Regarding 35 U.S.C. 103 rejections of claims 1-9, Applicant argues on p. 12-13 of Arguments/Remarks that the disclosures of De Waele and Dyell cannot be combined or one of obvious skill in the art would not have been motivated to modify the disclosure of De Waele with Dyell, because the control logic (open-loop) of De Waele would fundamentally alter the operation of the closed-loop logic found in Dyell. Examiner respectfully disagrees with Applicant’s arguments. Examiner does not rely on the combination of the open-loop logic and closed-loop logic together, but rather an entire teaching, suggestion, and/or modification of the open-loop logic found in De Waele to be entirely replaced by the closed-loop logic of Dyell. That is, De Waele substantially discloses the limitations found in independent claim 1 regarding transmission of modified delay values to patient monitoring devices, albeit not in an automated, closed-loop fashion. However, because De Waele generally discloses the use of loop logic for management of device parameters, specifically alarm delay values, Dyell is relied upon for the simple teaching, suggestion, and/or modification of the open-loop logic found in De Waele to be entirely replaced by the closed-loop logic of Dyell to create a combination of iteratively implementing the functionalities already disclosed in De Waele. As such, one of ordinary skill in the art would be motivated to completely modify the open-loop logic found in De Waele with the closed-loop logic of Dyell, because this allows for an automatic fatigue model to be generated using a feedback loop, such that a system can automatically modulate, i.e. modify, the alarm outputs so that user to automatically mitigate effects of the user’s alarm fatigue (See Dyell Par [0096]-[0099]). Therefore, claims 1-9 remain rejected under 35 U.S.C. 103.
Regarding 35 U.S.C. 103 rejections of claims 1-9, Applicant argues on p. 14-15 of Arguments/Remarks that De Waele and Dyell do not disclose newly added claims 10-13. Examiner agrees with Applicant’s arguments. However, an additional reference, i.e. Joshi, has been applied to the disclosures of De Waele and Dyell to fully read on newly added claims 10-13. Therefore, newly added claims 10-13 are not allowable over the prior art and are also rejected under 35 U.S.C. 103.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure:
Menzel et al. (U.S. Patent Publication No. 2022/0319304) discloses a system for reducing alarm nuisance behaviors by identifying events and alarms triggered in response to the identified events to analyze and identify at least one alarm nuisance behavior and subsequent alarm parameter modification;
Hu et al. (U.S. Patent Publication No. 2017/0100048) discloses automated determinations of whether a patient monitor alarm will sound from a true or false signal, such as to reduce false alarms by patient monitors;
Grantcharov et al. (U.S. Patent Publication No. 2021/0076966) discloses aspects of labeling one or more events during one or more medical data streams, such that post-analysis can be performed on various alerts and alarms based on said labels, including whether an alert is correct and/or a false alarm is issued.
Applicant's amendment necessitated the new ground 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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/H.R./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684