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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/16/2026 has been entered.
Applicant’s amendments and remarks filed on 02/16/2026 have been fully considered.
Claims 52-71 are pending for examination. Claims 1-51 are cancelled.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 52-71 are rejected under 35 U.S.C. 103 as being unpatentable over Lange (USPGPUB 2018/0132794 – cited in previous action) in view of Bryant et al. (USPGPUB 2019/0209084 – cited in precious action) and further in view of Sabesan (USPGPUB 2015/0305666).
Regarding independent claims 52 and 65, Lange discloses a monitoring
system configured to generate a risk score of a user of a wearable device (see Fig. 1 and [0002], "systems and method for determining an early warning score (EWS) based on wearable device measurements " early warning score interpreted as a risk score), the system comprising: a physiological sensor coupled to the wearable device (see Fig. 4C and [0053], “wearable device 110 can include optical sensors 222 located on an inner side of the wearable device 110", optical sensors 222 (i.e., physiological sensor) coupled to wearable device 110), said physiological sensor configured to detect attenuated light from a tissue site of the user (see Fig. 4C and [0045], " optical sensors 222 are operable to measure medical parameters associated with blood flow in an artery (for example, radial artery) using changing absorbance of light at different wavelengths in arterial blood and skin", optical sensors 222 measure attenuated light
(see claim interpretation regarding attenuated light above) from skin and radial artery of a user (i.e., a tissue site) using reflectance pulse oximetry); one or more light emitting diodes of the physiological sensor configured to transmit an optical radiation into the tissue site of the user (see Fig. 4C and [0055], " the optical sensors 222 include multiple light transmitters 450 (for example, Light Emission Diodes (LEDs)) when measuring the light reflected from the skin and radial artery light transmitter 450 (i.e., light emitting diode) transmits light (i.e., an optical radiation) to skin and radial artery (i.e., tissue site
of user)); one or more detectors of the physiological sensor configured to respond to an intensity of the optical radiation after absorption by the tissue site of the user (see Fig. 4C and [0055], " the optical sensors 222 include multiple light sensors 440 (photoelectric cells), to measure the reflected light when measuring the light reflected from the skin and radial artery " , light sensor 440 (i.e., light detector) measures light reflected by transmitter 450 (i.e., responds to an optical radiation) from the patient's skin and radial artery (i.e., tissue site of user). See also [0045], "optical sensors 222 are operable to measure medical parameters using changing absorbance of light at different wavelengths in arterial blood and skin", light sensor 440 responds to light reflected from by transmitter 450 using the change of light absorbance (i.e., light sensor 440 responds to the change in intensity of light at the skin and radial artery (i.e., tissue site)); a display configured to display one or more screens (see [0034], " mobile device 140 can
be operable to receive the sensor data and medical parameters from the wearable device 110 mobile device 140 runs one or more applications that provide, via a graphical display system, charts and graphics concerning medical parameters of the patient", mobile device 140 receives data from wearable device 110, and graphically displays charts and graphics (i.e., displaying multiple charts and graphics using applications is interpreted as displaying one or more screens); and at least one hardware processor in communication with the physiological sensor (see Fig.
2 and [0039]-[0040], " wearable device 110 includes sensors 120 processor 220 processor 220 can include hardware and/or software, which is operable to execute computer programs including processing and analyzing sensor data ", processor 240 (i.e., hardware processor) communicates with sensor 120 (see also [0044], " the sensors 120 include optical sensors 222 ")), the at least one hardware processor configured to: determine a plurality of parameters based at least on the attenuated light from the physiological sensor (see [0045], " optical sensors 222 are operable to measure medical parameters using changing absorbance of light multiple medical parameters " optical sensors 222 measure change in light absorbance (i.e., attenuation) to determine physiological parameters); determine a plurality of characteristics based on the plurality of parameters (see [0030], "The medical parameters can be analyzed to determine trends in the medical parameters ", trends in medical parameters (i.e., characteristics of the parameters) determined from measured parameters), the plurality of characteristics associated with at least one of instantaneous values or historical values of the plurality of parameters (see [0079], " based on a deviation of a current value of the medical parameter from a normal value of the medical parameter normal value can be determined based on historical values of the medical parameter ", trends (i.e., characteristics) are based on current values (i.e., instantaneous) and normal patient values, which are determined from historical patient values), the plurality of characteristics comprising user trend characteristics and stability characteristics ([0031], " determining, by the at least one processor and based on the initial values, normal values of the medical parameters determining, by the at least one processor and based on deviations of the further values from the normal values, individual scores for the medical parameters ", normal values (i.e., trend characteristics) are determined for the patient based measured parameters, and individual scores (stability characteristic) are determined based on deviations of values of measured parameters from a normal patient value), wherein the user trend characteristics track the plurality of parameters over a period of time (see [0079], " normal value can be determined based on historical values of the medical parameter collected during an initial time interval, for example, several days or weeks", normal values (i.e., trend characteristics) track measured
parameters based on historical data collected over a time period), and wherein the stability characteristics measure a degree of which instantaneous parameter values corresponding to the plurality of parameters tend to deviate from their historical values (see [0079], “individual score of a medical parameter is determined based on a deviation of a current value of the medical parameter from a normal value normal value can be determined based on historical values of the medical parameter collected during an initial time interval , individual scores (i.e., stability characteristics) calculated based on how much a measured parameter differs from a historical normal value (i.e., deviation from a historical value)), wherein at least one of large or frequent deviations are indicative of high parameter instability (see [0037], "If the deviation in the medical parameters becomes sufficiently large " see also [0079] - [0080], " based on a deviation of a current value of the medical parameter from a normal value with a deviation from the normal value on both sides of the normal value ", large deviations of a parameter on both sides of a normal value (i.e., large deviations), such deviations occurring both above and below a normal value indicating instability of the parameter); determining a risk score based on at least the user trend characteristics and the stability characteristics (see [0031], " determining based on deviations of the further values from the normal values, individual scores for the medical parameters calculating, by the at least one processor and based on the individual scores, a general score" general score (i.e., risk score) is calculated depending on the normal values for the patient (i.e., user trend characteristics) and individual scores (i.e., stability characteristics)); determine an alarm level of a series of escalating alarm levels based on the score (see [0082], "If the general score exceeds a pre-determined threshold, the patient can be issued a warning signal. warning signal can be also issued if one of the individual scores reaches a maximum value " issue warning signal (alarm) when general score exceeds a threshold, and when it exceeds a maximum value (i.e., escalating alarm levels)); and implement an intervention associated with the determined alarm level (see [0082], “determining an appropriate treatment for the patient can be used to determine or adjust a frequency for acquiring medical parameters and calculating individual scores", determining treatment for a patient or adjusting measurement frequency (i.e., implementing an intervention) based on the score (and the alarm associated with the score exceeding a threshold value or maximum value)).
However, Lange fails to disclose an opioid overdose monitoring system configured to generate an overdose risk score of a user of a wearable device.
Bryant teaches wearable systems for monitoring patient parameters to prevent overdose deaths (see abstract), including opioid overdoses (see [0045], " having "overdosed on" an opiate "), by providing alerts to patients wearing the device, and third parties, to prevent overdose (see [0100], " wireless narcosis alert 200 provides alerts to the affected person, and provides alerts to concerned third parties result is actionable information is provided in timely fashion to prevent death due to overdose "). Bryant further teaches using photoplethysmography sensors to provide pulse oximetry to measure parameters affecting overdose determination, and use measured parameters to generate alerts ( see [0018]-[0019], "Sensors in the wearable narcosis alert device and system provide pulse oximetry data, using photoplethysmography technology to
make deductions concerning the wearer's medical condition, and to issue alerts about the wearer's condition ").
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the score disclosed by Lange to determine an overdose risk score for the purpose of providing timely and actionable information to prevent overdose death, as evidence by Bryant (see [0100]). Furthermore, one of ordinary skill in the art would have had predictable success combining Lange and Bryant since both teachings relate to the same narrow field of endeavor, i.e., wearable health monitoring systems using photoplethysmography.
Additionally, Lange fails to disclose wherein the stability characteristics measure a degree of which instantaneous parameter values corresponding to the plurality of parameters tend to deviate from their historical values and wherein at least one of large or frequent deviations are indicative of high parameter instability.
Bryant teaches decision making criteria for determining a condition of a patient based on variation from baseline patient parameters (see [0088/, " primary decision-making criteria for alerting on medical conditions recorded information provides the individual's baseline establishing "normal activity. "") by measuring patient parameters over different time intervals (see [0089], "With each measurement, look back at data from each of 24 hours ago 4 hours ago 2 hours ago 1 hour ago 30 minutes ago 5 minutes ago ") and using variations of measured parameters from baseline parameters, and patterns of measured parameters, to determine the patient's condition (see [0089], " variations from the baseline or patterns from analysis of the look back ", , patterns from analysis indicating an increase in a frequency of occurrence of measured parameters varying from the baseline (i.e., an increase in frequency of measured parameter derivation compared to historical values)).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify Lange to indicate parameter instability (i.e., based on large or frequent derivations from the baseline), for the purpose of accurately determining the condition of a patient, as evidence by Bryant (see [0089]).
Additionally, Lange fails to disclose determining an overdose risk score based on at least the user trend characteristics and the stability characteristics.
Lange discloses determining a risk score (i.e., general score) based on normal values (i.e., trend characteristics) and individual scores (i.e., stability characteristics) of a patient (see [0031]). The Lange/Bryant combination, as described above, teaches a monitoring system for determining an overdose risk score. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify determining the general score disclosed by Lange to determine the overdose risk score taught by the Lange/Bryant combination, for the purpose of indicating user conditions based on a patient's normal activity, as evidence by Bryant
(see [0088]).
Additionally, Lange fails to disclose determine an alarm level of a series of escalating alarm levels based on the overdose risk score.
Bryant teaches determining variations from the baseline measurements taken from patients wearing the device to provide patient alerts indicating the condition (i.e., an overdose condition) of the device user (see [0088], " Variation from this baseline, observed in real time and compared with recent history, would indicate certain conditions upon which the device would provide alerts to interested parties comprises the suspected condition of the wearer based on analysis "). Lang discloses determining an alarm condition based on a risk score using measured physical parameters (see [0082]). Bryant teaches alerting a user, or a third party, of an overdose condition based on analyzing the difference between a baseline measurement and a measurement
that varies from the baseline. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify Lange to determine an escalating alarm level based on an overdose risk score, for the purpose of issuing appropriate alerts to the user and the outside world , as evidence by Bryant (see [0087]).
The Lange/Bryant combination, as described above, discloses the stability characteristics are determined based on a deviation of a current value of the medical parameter from a normal value and normal value can be determined based on historical values of the medical parameter collected during an initial time interval (see [0079] of Lange, “individual score of a medical parameter is determined based on a deviation of a current value of the medical parameter from a normal value, normal value can be determined based on historical values of the medical parameter collected during an initial time interval , individual scores (i.e., stability characteristics) calculated based on how much a measured parameter differs from a historical normal value (i.e., deviation from a historical value)) and Bryant teaches alerting a user, or a third party, of an overdose condition based on analyzing the difference between a baseline measurement and a measurement that varies from the baseline but fails to teach the stability characteristics are determined over a moving time window of recent values.
Sabesan teaches a medical device for measuring medical/ physiological parameters and associated information (heartbeat data, Fig. 2 and associated descriptions; abstract; see [0028], “heartbeat data”) and a background heart rate is determined over a moving time window of recent values (e.g. normal or baseline heart rate, see [0006], “The foreground heart rate may correspond to a rate at which the patient's heart is beating at a present time, which can be the most-recent heart rate value obtained from the patient or be an average of several recent heart rate values that are adjacent to and include the most-recent heart rate value. The background heart rate may be a function of the foreground heart rate and a previously-determined background heart rate. For example, the algorithm may be expressed as BG.sub.n=λ*BG.sub.n-1+(1−λ)*FG.sub.n, where BG.sub.n is the background heart rate at the present time (n), BG.sub.n-1 is the previously-determined background heart rate, FG.sub.n is the foreground heart rate at the present time (n), and λ is a weighting factor. The previously-determined background heart rate may correspond to an average heart rate during a moving period of time or time window (e.g., an average heart rate during a moving five minute time window that remains immediately prior to the present time), with the period of time or time window being selected to capture a sufficient number of stable heart beats to provide an average heart rate value that is representative of the patient's heart rate and not heavily influenced by any extremely-high or low single heart beat or grouping of heart beats”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the determination(s) of the normal value of the stability characteristics, disclosed by the Lange/Bryant combination, to determine the normal value over a moving time window of recent values, for the purpose of reducing the influence of any extremely-high or low single heart beat/ parameter or grouping of heart beats/ parameters, as evidence by Sabesan (see [0006]).
Regarding claims 53 and 66, the Lange/Bryant/Sabesan combination further discloses wherein the plurality of parameters comprises at least one of oxygen saturation (SpO₂), respiration (PR), or perfusion index (PI) (see Lange [0044], " medical parameters 310, determined based on the sensor data, include SpO2 oxygen saturation, tissue oxygen saturation, cardiac output, vascular resistance, pulse rate, blood pressure, respiration parameters include oxygen saturation (SpO2) and respiration).
Regarding claims 54 and 67, the Lange/Bryant/Sabesan combination further discloses wherein the plurality of parameters further comprises at one of respiration rate from the pleth (RRp) via a blood volume plethysmograph waveform or temperature (see Lange [0046], "respiration can be derived from a sinus arrhythmia waveform waveform can be obtained based on intervals between subsequent heart beats (RR intervals) measured by the optical sensors " , respiration rate (RR) parameter obtained from intervals in waveform measured by optical sensors. see also Lange [0068], " estimate a body temperature of the patient based on measurements of the skin temperature and the external temperature , skin, body, or external temperature measured (i.e., temperature parameter)).
Regarding claim 55, the Lange/Bryant/Sabesan combination discloses the invention as claimed above in claim 53/52. The Lange/Bryant combination further discloses wherein the at least one hardware processor monitors a decrease of the SpO2 (see Lange [0056], " oxygen saturation and tissue saturation can be measured using the same optical sensor , oxygen saturation monitored by optical sensors. See also Bryant Fig. 5 and [0100], " deduced conditions 502 and associated heart rate 506 and SpO2 504. decline in SpO2 is monitored over time, and reported as a rate of decline relative to previously measured values).
However, the Lange/Bryant/Sabesan combination is silent regarding monitoring a lower limit of the SpO2. The Lange/Bryant/Sabesan combination discloses monitoring a decrease in oxygen saturation (i.e., SpO2) over time, relative to previously measured values, and determines an overdose risk condition based on the rate of decline of oxygen saturation. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the Lange/Bryant/Sabesan combination to monitor a lower limit (of SpO2), for the purpose of providing actionable information in a timely manner, as evidence by Bryant (see [0100]).
Regarding claims 56 and 68, the Lange/Bryant/Sabesan combination further discloses wherein the at least one hardware processor is further configured to, for each of the plurality of parameters (the processor and plurality of parameters of the Lange/Bryant/Sabesan combination, as described above), determine a baseline risk (see Bryant [0088], "For each particular wearer of the wearable narcosis alert device, recorded information provides the individual's baseline establishing "normal activity" , baseline information indicating a baseline risk), an instability index (see Bryant [0101], " baseline modulation, or "baseline wander, parameter exists adds modulation to the baseline , interpreted as an instability index (i.e., variation from the baseline), an average slope (see Lange [0059], " determined using individual waveform parameters, or may be a time-averaged estimate, derived from averaged pulse oximeter readings over a specified time period ", averaged parameter estimate derived over time (i.e., average slope) and desaturation pressure (see Lange [0056], "When heart or lungs are not functioning properly, the saturation of oxygen drops tissue oxygen saturation can be measured by sensing the skin color the oxygen saturation and tissue saturation can be measured using the same optical sensor , desaturation pressure interpreted as a drop in measured saturation of oxygen), and determine a weighted aggregate (weighted aggregate of the Lange/Bryant/Sabesan combination, described above).
However, the Lange/Bryant/Sabesan combination fails to disclose determining a weighted aggregate of the baseline risk, the instability index, the average slope, and the desaturation pressure.
Bryant further teaches using weighted averages over a period of time to estimate a respiratory parameter, and filter out non-respiratory causes of variability in the measured respiratory parameter (see [0103], " relying on HRV and changes in the interval between heart beats due to inspiration and expiration tracks the changes over time to mark respiration cycles applies weighted averages at 5 minute epochs result is the filtering out non-respiratory causes "). The Lange/Bryant/Sabesan combination (as applied to claims 52 and 65 above) discloses determining an overdose risk score using weighted summations of patient parameters (see [0077]). Bryant teaches using weighted averages over time to consider factors unrelated to the measured parameter (i.e., weighted aggregates, that consider the relative importance of groups of data).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the Lange/Bryant/Sabesan combination to determine a weighted aggregate (of the baseline risk, instability index, average slope, and desaturation pressure), for the purpose of improving parameter estimation accuracy, as evidence by Bryant (see [0103]).
Regarding claims 57 and 69, the Lange/Bryant/Sabesan combination further discloses wherein the alarm level (of the Lange/Bryant/Sabesan combination described above) is characterized by values of the overdose risk score (see Lange [0082], " score exceeds a pre-determined threshold, the patient can be issued a warning signal warning signal can be also issued if one of the individual scores reaches a maximum value" alarm characterized by score values (i.e., values of overdose risk score of the Lange/Bryant combination), a normalized value corresponding to SpO2 levels over a period of time and SpO2 (see Lange [0078]-[0079], , " monitored medical parameters may include an oxygen saturation the wearable device may be configured to provide a signal to the patient 130 by the alarm unit 250 normal value can be determined based on historical values of the medical parameter collected during an initial time interval ", normal parameter value (i.e., oxygen saturation (i.e., SpO2 level, a physiological parameter) value determined for individual patients over time, and used to characterize alarms).
However, the Lange/Bryant/Sabesan combination fails to disclose wherein the alarm level is characterized by values of the overdose risk score, a normalized area corresponding to SpO2 levels over a period of time, and SpO2.
The Lange/Bryant/Sabesan combination discloses using a normalized value of measured parameters (i.e., SpO2 over time) to characterize alarms. Additionally, Lange teaches a processor performing operations to analyze sensor data to determine monitored parameters (see Lange [0040], "processor 220 can use and other operations, including processing and analyzing sensor data to obtain current medical parameters and the EWS (early warning score) of the patient") and determining a cardiac output (CO) parameter from averaged pulse oximeter readings over a period of time (see Lange [0059], " CO estimate can be determined using individual pulse oximetry waveform parameters may be a time-averaged estimate, derived from and averaged pulse oximeter readings over a specified time period").
Modifying obtaining a normal value of SpO2 levels over time disclosed by the Lange/Bryant/Sabesan combination, to apply Lange's teaching of complex computation of measured parameters and averaging pulse oximeter waveform readings over time, would obtain the predictable result of computing a normal area under a SpO2 waveform curve over time. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the Lange/Bryant/Sabesan combination to characterize an alarm score with a normal area (ofSpO2 levels over time), for the purpose of providing a more precise evaluation of individual patients, as evidence by Lange (see [0081]).
Regarding claims 58 and 70, the Lange/Bryant/Sabesan combination further discloses wherein the overdose risk score is based on a history of the plurality of parameters (see Lane [0037], " medical parameters can be specific to the patient 130 and can be derived based on historical data concerning the patient's health status recorded over an extended time period ", overdose risk score (of Lange/Bryant/Sabesan combination) based on historical patient parameter values).
Regarding claim 59, the Lange/Bryant/Sabesan combination further discloses wherein the physiological sensor detects the plurality of parameters periodically (see Lange [0008], " processor can be further configured to acquire, via the sensors and at a pre-determined frequency, further values of the medical parameters", parameter values are measured at a pre-determined frequency (i.e., periodically).
Regarding claim 60, the Lange/Bryant/Sabesan combination further discloses wherein the at least one processor further correlates one or more trends of the plurality of parameters (see Lange [0033], "medical parameters can be analyzed to obtain changes (trends) in medical parameters and the EWS of health status of the patient over time. Based on the changes and the EWS, one or more conclusions regarding severity of one or more chronic disease can be obtained", processor (of the Lange/Bryant/Sabesan combination) analyzes changes in parameter data (i.e., trends) to obtain conclusions (i.e., correlate trends)).
Regarding claim 61, the Lange/Bryant/Sabesan combination further discloses wherein the at least one processor is further configured to correlate trends of multiple parameters of the plurality of parameters (see Lane [0033], " operable to obtain medical parameters associated with the patient 130. The medical parameters can be analyzed to obtain changes (trends) in medical parameters processor (of the Lange/Bryant/Sabesan combination) analyzes trends of multiple parameters).
Regarding claim 62, the Lange/Bryant/Sabesan combination further discloses wherein the at least one hardware processor is configured to determine a plurality of alarm levels in parallel (see Lange [0082], "If the general score exceeds a pre-determined threshold, the patient can be issued a warning signal using, for example an alarm unit of the wearable device warning signal can be also issued if one of the individual scores reaches a maximum value", both a general score and individual scores are compared to pre-determined thresholds, and warning signal (i.e., alarm) is issued if the general score and/or an individual score exceeds the pre-determined threshold (i.e., alarm levels are determined in parallel for the general score and individual scores)).
Regarding claim 63, the Lange/Bryant/Sabesan combination further discloses wherein the at least one processor is further configured to determine the presence of an event based on the crossing of at least one of a first or instantaneous baseline across one or more event thresholds (see Bryant [0087], " measure 418 current wearer data; record 420 current wearer data (via write access 410) into database 414; a look back 422 at data in the database 414 analysis of current data for the wearer compared with historical and baseline data. A check for out of range 424 in any of the monitored parameters If the false positive check 426 indicates that the data are correct, an alarm 430 sequence is initiated", determining if measured data, as compared to baseline patient data, are outside of a range (i.e., data are outside one or more thresholds), initiates an alarm sequence (i.e., indicates presence of an event)) .
Regarding claim 64, the Lange/Bryant/Sabesan combination further discloses wherein the alarm level (of the Lange/Bryant/Sabesan combination described above) is characterized by values of the overdose risk score (see Lange [0082], " score exceeds a pre-determined threshold, the patient can be issued a warning signal warning signal can be also issued if one of the individual scores reaches a maximum value", alarm characterized by score values (i.e., values of overdose risk score of the Lange/Bryant/Sabesan combination of claim 1 above), a normalized value, and a physiological parameter (see Lange [0078]-[0079], " monitored medical parameters may include an oxygen saturation the wearable device may be configured to provide a signal to the patient 130 by the alarm unit 250 normal value can be determined based on historical values of the medical parameter collected during an initial time interval ", normal parameter value (i.e., SpO2 level, a physiological parameter) value determined for individual patients over time, and used to characterize alarms)).
However, the Lange/Bryant/Sabesan combination fails to disclose wherein the alarm level is characterized by values of the overdose risk score, a normalized area, and a physiological parameter.
The Lange/Bryant/Sabesan combination discloses using a normalized value of measured parameters (i.e., SpO2 over time) to characterize alarms. Additionally, Lange teaches a processor performing operations to analyze sensor data to determine monitored parameters (see Lange [0040], "processor 220 can use and other operations, including processing and analyzing sensor data to obtain current medical parameters and the EWS (early warning score) of the patient") and determining a cardiac output (CO) parameter from averaged pulse oximeter readings over a period of time (see Lange [0059], " CO estimate can be determined using individual pulse oximetry waveform parameters may be a time-averaged estimate, derived from and averaged pulse oximeter readings over a specified time period").
Modifying obtaining a normal value of SpO2 levels over time disclosed by the Lange/Bryant/Sabesan combination, to apply Lange's teaching of complex computation of measured parameters and averaging pulse oximeter waveform readings over time, would obtain the predictable result of computing a normal area under a SpO2 waveform curve over time. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the Lange/Bryant/Sabesan combination to characterize an alarm score with a normal area (ofSpO2 levels over time), for the purpose of providing a more precise evaluation of individual patients, as evidence by Lange (see [0081]).
Regarding claim 71, the Lange/Bryant/Sabesan combination further discloses wherein the at least one hardware processor is further configured to determine unavailability or unreliability of the plurality of parameters (see Bryant [0087], " the false positive check 426 indicates that the data are correct, an alarm 430 sequence is initiated false positive check determines if parameter data is outside of a determined range, (i.e., reliability of parameters).
However, the Lange/Bryant/Sabesan combination is silent regarding determining the unreliability of the plurality of parameters.
The Lange/Bryant/Sabesan combination discloses validating measured parameters by performing a false-positive test to compare the measured parameters to a pre-determined range (see Bryant [0087]). Although the Lange/Bryant/Sabesan combination is silent regarding explicitly determining the unreliability of measured parameters, checking measured parameters against a range of values to determine if any are out of range, would separate valid data (i.e., data determined to be reliable) from invalid data (i.e., data determined to be unreliable)). Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the Lange/Bryant/Sabesan combination to determine the unreliability of measured parameters for the purpose of avoiding false alarms, as evidence by Bryant (see [0087]).
Response to Arguments
Applicant’s amendment and argument with respect to claims 52 and 65 filed on 02/16/2026 have been fully considered but they are deemed to be moot in views of the new grounds of rejection.
Conclusion
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/CHU CHUAN LIU/ Primary Examiner, Art Unit 3791
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