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 .
Status of the Application
Claims 1-17 are currently pending in this case and have been examined and addressed below. This communication is a Final Rejection in response to the Amendments to the Claims and Remarks filed on 11/07/2025.
Claims 1, 2, and 5-6 are currently amended.
Claim 17 is added.
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 1-3, 5-8, 10-13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Aron et al. (US-20140134585-A1)[hereinafter Aron], in view of HALPERIN et al. (US-20080275349-A1)[hereinafter Halperin], in view of Tehrani (US-8695593-B2)[hereinafter Tehrani].
As per Claim 1, Aron discloses a system for guiding clinical treatments in paragraphs [0044] and [0049] (a system for assessing and developing oral feeding capabilities for an infant (synonymous to a system for guiding clinical treatments)), comprising: and output circuitry for outputting the treatment protocol in paragraphs [0051] and [0053] (a display (synonymous to an output circuitry) display therapy protocols (synonymous to treatment protocol)); wherein the input circuitry is adapted to receive biosignals as measured from the monitored patient in the form of a preterm infant during an oral feeding activity in paragraphs [0046] and [0049] and [0067] and Figure 2 (the input device (synonymous to the input circuitry) receives nutritive sucking patterns (synonymous to biosignals) measured from a monitored preterm infant during an oral feeding); wherein the treatment protocol comprises a recommended regimen for guiding clinical care of the monitored infant, the recommended regimen comprising one or more clinical interventions for a clinical caregiver to follow for promoting a predetermined outcome for improved oral feeding of the monitored infant in paragraphs [0032-0033] and [0046] and [0049-0050] and [0053] and [0076] and [0082-0084] and [0101] claim 1 (therapy protocols includes a recommended regimen for developing strength through therapy (synonymous to guiding clinical care) of the monitored infant, the recommended regimen including therapy with a pacifier, physical stimulation, or repeated therapy with the therapeutic stimulus system for a user (synonymous to a clinical caregiver) to follow for promoting rhythmic motor behaviors (synonymous to predicted outcomes) such as sucking, breathing, mastication, and locomotion for improved oral feeding of the monitored patient (Examiner notes that therapy given through a pacifier, physical stimulation, or through the therapeutic stimulus system are synonymous to clinical interventions)).
Aron discloses receiving biosignals but does not disclose the following limitations. However, Halperin discloses input circuitry adapted for receiving biosignals from at least one biosignal sensor that is adapted to transmit biosignals of a monitored patient in paragraphs [0602] and [0604-0605] and [0617] and Figure 2 (a control unit (synonymous to an input circuitry) to receive biosignals from at least one biosignal sensor to transmit biosignals of a monitored patient); at least one processor adapted for processing received biosignals to generate a treatment protocol for the monitored patient in paragraphs [0605] and [0608] (breathing pattern analysis module (synonymous to at least one processor) processes received biosignals to generate preventive treatment (synonymous to a treatment protocol), wherein the generated treatment corresponds to predicting a clinical event or episode, for the monitored patient).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron, to be combined with an input circuitry that receives biosignals from a sensor and a processor processing the signals to generate a treatment protocol, as disclosed by Halperin, for the purpose of increasing the effectiveness of preventive treatment of abnormal physiological conditions [0011-0012].
Aron and Halperin do not disclose the following limitations. However, Tehrani discloses and wherein the output circuitry is further adapted to control a respiratory support system associated with the monitored patient, based on the recommended regimen, to automate titration of oxygen provided to the monitored patient, so as to ensure a measured oxygen saturation level from the at least one biosignal sensor stays within a predetermined acceptable range in column 1 lines 52-59, column 2 lines 4-21, column 3 lines 9-13, column 4 lines 10-44, column 5 lines 44-50, and column 10 line 65-column 11 line 27 (control a mechanical ventilator (synonymous to a respiratory support system) associated with the monitored patient, based on the recommended regimen, to automatically adjust the oxygen provided to the monitored patient, to ensure the measured oxygen level from the pulse oximeter (synonymous to the at least one biosignal sensor) stays within a predefined acceptable interval).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron and Halperin, to be combined with controlling a respiratory support system, based on the recommended regimen, to automate titration of oxygen to ensure a measured oxygen saturation level stays within a predetermined acceptable range, as disclosed by Tehrani, for the purpose of expediting recovery and reducing mortality and morbidity risks [column 1 lines 21-30].
As per Claim 2, Aron, Halperin, and Tehrani discloses the system according to claim 1.
Aron discloses receiving biosignals but does not disclose the following limitations. However, Halperin discloses wherein: the input circuitry is adapted to receive biosignals as waveforms in paragraphs [0604] and [0617] and [0627] (the control unit receives biosignals as waveforms); and the processor is adapted to process a received biosignal waveform to clean useful data from the biosignal waveform, calculate a health score from the cleaned biosignal waveform, and generate a treatment protocol based on the health score via a clinical algorithm that applies predefined rules in paragraphs [0605] and [0608] (breathing pattern analysis module processes the received biosignal waveform to extract breathing patterns from the raw data (synonymous to clean useful data from the biosignal waveform), to derive a score (synonymous to calculate a health score) from the extracted breathing patterns (synonymous to the cleaned biosignal waveform) and generate preventive treatment based on the score via learning the criteria or functions by analyzing parameters measured prior to previous clinical events (Examiner notes that the module learns through a clinical algorithm that applies the criteria or predefined rules)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron, to be combined with an input circuitry that receives biosignals as waveforms and clean useful data from the biosignal waveform to calculate a health score, and generate a treatment protocol, as disclosed by Halperin, for the purpose of increasing the effectiveness of preventive treatment of abnormal physiological conditions [0011-0012].
As per Claim 3, Aron, Halperin, and Tehrani discloses the system according to claim 2, Aron further discloses the processor is adapted to generate a treatment protocol comprising a recommended regimen that comprises one or more clinical interventions in the form of therapeutic interventions and/or medical interventions in paragraphs [0032-0033] and [0046] and [0049-0050] and [0053] and [0076] and [0082-0084] and [0101] claim 1 (therapy protocols (synonymous to treatment protocol) includes a recommended regimen including therapy with a pacifier, physical stimulation, or repeated therapy with the therapeutic stimulus system (Examiner notes that therapy given through a pacifier, physical stimulation, or through the therapeutic stimulus system are synonymous to clinical interventions in the form of therapeutic interventions)).
Aron discloses receiving biosignals but does not disclose the following limitations. However, Halperin discloses wherein: the input circuitry is adapted to receive biosignal waveforms in the form of respiratory waveforms in paragraphs [0604-0605] and [0611] and [0617] and [0627] (the control unit receives biosignal waveforms in the form of breathing patterns referred to as respiratory patterns (synonymous to respiratory waveforms)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron, to be combined with an input circuitry that receives biosignals as waveforms, as disclosed by Halperin, for the purpose of increasing the effectiveness of preventive treatment of abnormal physiological conditions [0011-0012].
As per Claim 5, Aron, Halperin, and Tehrani discloses the system according to claim 3.
Aron discloses receiving biosignals but does not disclose the following limitations. However, Halperin discloses wherein: the processor is adapted to generate a treatment protocol through a series of steps that comprises: matching the received biosignal with a corresponding treatment outcome in paragraphs [0605] and [0608] (breathing pattern analysis module generate preventive treatment by matching the combined scores, wherein the combined scores are derived from the breathing patterns, with the clinical episodes that have been predicted, occurring, or neither predicted nor occurring (Examiner notes that the clinical episode being predicted, occurring, or neither predicted nor occurring correspond to treatment outcomes as predicting a clinical episode generates an early preventive treatment)); interpreting the received biosignal as a rating of the patient's progress toward the corresponding treatment outcome in paragraphs [0608] (the combined score also monitors the severity and progression of an occurring clinical episode (Examiner notes that the combined score derived from the received breathing pattern is a rating of the patient's progress towards an occurring episode or a treatment outcome)); cross-referencing the rating of the received biosignal with pre-established records for biosignals of the same type in paragraphs [0608] (the combined score is compared to predetermined threshold values (synonymous to pre-established records for biosignals of the same type) (Examiner notes that comparing the combined score to the threshold value is synonymous to cross-referencing the rating with pre-established records)), the pre-established records comprising various ratings for the biosignal in paragraphs [0608] (the predetermined thresholds include scores based on population averages for the breathing pattern from previous clinical episodes which are associated with whether an episode is predicted, currently occurring, or neither predicted nor occurring (Examiner notes that the population averages for the breathing pattern includes various scores for breathing patterns)), treatment outcomes associated with the various ratings of the biosignal, and therapeutic interventions and/or medical interventions associated with the various ratings of the biosignal in paragraphs [0608] (the preventive treatments are associated with the population averages of the breathing pattern from previous clinical episodes); and outputting one or more therapeutic interventions and/or medical interventions associated with the interpreted rating of the received biosignal in paragraphs [0605] and [0608] (outputting preventive treatments associated with the analysis of the breathing pattern).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron, to be combined with generating a treatment protocol through a series of steps, as disclosed by Halperin, for the purpose of increasing the effectiveness of preventive treatment of abnormal physiological conditions [0011-0012].
As per Claim 6, Aron, Halperin, and Tehrani discloses the system according to claim 5, Aron further discloses wherein: the processor is adapted to generate a treatment protocol in which: the biosignal is matched with a treatment outcome in the form of preterm infant feeding outcomes in paragraphs [0032-0033] and [0046] and [0049-0050] and [0053] and [0076] and [0082-0084] and [0101] claim 1 (generate therapy protocols for promoting rhythmic motor behaviors (synonymous to treatment outcomes) such as sucking, breathing, mastication, and locomotion for improved oral feeding of the monitored patient); the pre-established records comprise various ratings for respiratory waveforms measured during oral feeding activity, feeding associated with the various measured respiratory waveforms in paragraphs [010] and [0046] and [0067] (the respiratory waveforms measured during the oral feeding activity, feeding associated with the nutritive suck pattern, wherein nutritive suck pattern includes measured respiratory waveforms), and therapeutic interventions and/or medical interventions for achieving a targeted feeding outcome based on the various measured respiratory waveforms in paragraphs [0032-0033] and [0046] and [0049-0050] and [0053] and [0076] and [0082-0084] and [0101] claim 1 (therapy with a pacifier, physical stimulation, or repeated therapy with the therapeutic stimulus system for promoting rhythmic motor behaviors such as sucking, breathing, mastication, and locomotion for improved oral feeding of the monitored patient based on the nutritive suck pattern).
Aron discloses generating treatment protocols but does not disclose the pre-established records including ratings for respiratory waveforms. However, Halperin discloses the processor is adapted to generate a treatment protocol in which: the biosignal is matched with a treatment outcome in paragraphs [0605] and [0608] (breathing pattern analysis module generate preventive treatment by matching the combined scores, wherein the combined scores are derived from the breathing patterns, with the clinical episodes that have been predicted, occurring, or neither predicted nor occurring (Examiner notes that the clinical episode being predicted, occurring, or neither predicted nor occurring correspond to treatment outcomes as predicting a clinical episode generates an early preventive treatment)); the pre-established records comprise various ratings for respiratory waveforms in paragraph [0608] (the predetermined thresholds include scores based on population averages for the breathing pattern from previous clinical episodes).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron, to be combined with generating a treatment protocol in which the biosignal is matched with a treatment outcome, as disclosed by Halperin, for the purpose of increasing the effectiveness of preventive treatment of abnormal physiological conditions [0011-0012].
As per Claim 7, Aron, Halperin, and Tehrani discloses the system according to claim 6.
Aron also discloses wherein: the processor is adapted to use data from an electronic health record of the monitored infant to informs a rigidity or adaptability of the preterm monitored infant's breathing patterns during oral feeding in paragraphs [0053] and [0057-0059] and [0070] (use patient data from patient charts (synonymous to an electronic health record) of the monitored infant to assess the nutritive sucking pattern of the preterm monitored infant during oral feeding, wherein the assessment of the nutritive sucking pattern includes the adaptability of the preterm monitored infant's breathing patterns).
Aron discloses using data from an electronic health record of the infant to informs the adaptability of the infant’s breathing patterns during oral feeding, but does not disclose generating a feature mix. However, Halperin discloses the processor is adapted to use data from an electronic health record of the monitored to generate a feature matrix that informs a rigidity or adaptability of the breathing patterns in paragraphs [0607] and [0773] (use clinical parameters (synonymous to data from an electronic health record) of the monitored patient to generate a four dimensional feature vector (synonymous to a feature matrix) that is classified into regular, irregular, or highly irregular breathing of the monitored patient (synonymous to informs a rigidity or adaptability to breathing patterns)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron, to be combined with using data from an electronic health record of an infant to generate a feature matrix, as disclosed by Halperin, for the purpose of increasing the effectiveness of preventive treatment of abnormal physiological conditions [0011-0012].
As per Claim 8, Aron, Halperin, and Tehrani discloses the system according to claim 7.
Aron does not disclose the following limitations. However, Halperin discloses wherein: the feature matrix is inclusive of one or more factors selected from: infant demographics, maternal factors, physiological factors, and measures of feeding performance in paragraph [0773] (the four dimensional feature vector includes regular, irregular, and highly irregular breathing (Examiner notes that types of breathing are physiological factors)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron, to be combined with the feature matrix including physiological factors, as disclosed by Halperin, for the purpose of increasing the effectiveness of preventive treatment of abnormal physiological conditions [0011-0012].
As per Claim 10, Aron, Halperin, and Tehrani discloses the system according to claim 2.
Aron does not disclose the following limitations. However, Halperin discloses wherein: the processor is adapted to take one or more actions based on received biosignals and/or calculated health scores in paragraph [0608] (the breathing pattern analysis module determines whether an episode is predicted, currently occurring, or neither predicted or occurring or to monitor the severity and progression of an occurring episode based on the derived scores).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron, to be combined with taking one or more actions based on the calculated health scores, as disclosed by Halperin, for the purpose of increasing the effectiveness of preventive treatment of abnormal physiological conditions [0011-0012].
As per Claim 11, Aron, Halperin, and Tehrani discloses the system according to claim 10.
Aron does not disclose the following limitations. However, Halperin discloses wherein: the processor is adapted to take an action when a biosignal and/or health score is either below a lower threshold value or above an upper threshold value for a predetermined corresponding target range of the biosignal and/or health score in paragraph [0608] (the breathing pattern analysis module determines whether an episode is predicted, currently occurring, or neither predicted or occurring or to monitor the severity and progression of an occurring episode when the score is compared to a predetermined threshold value (Examiner notes that the predetermined threshold value corresponds to a target range of the score)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron, to be combined with taking an action when the calculated health scores fall outside of a threshold, as disclosed by Halperin, for the purpose of increasing the effectiveness of preventive treatment of abnormal physiological conditions [0011-0012].
As per Claim 12, Aron, Halperin, and Tehrani discloses the system according to claim 2.
Aron does not disclose the following limitations. However, Halperin discloses wherein: the processor is adapted to clean useful data from a received biosignal waveform in paragraphs [0605] and [0608] (breathing pattern analysis module processes the received biosignal waveform to extract breathing patterns from the raw data (synonymous to clean useful data from the biosignal waveform)) through a series of steps that comprises: setting a defined waveform range for valid data, in which values within the defined waveform range are deemed valid data and values outside the defined waveform range are deemed potential artifact data in paragraph [0625] (setting a spectral filtering range (synonymous to a defined waveform range) for breathing-related signals (Examiner notes that the spectral filtering range allows wavelengths within the range to pass through, which is synonymous to deeming the data valid, and blocks wavelengths that are outside of the range, which is synonymous to deeming the data as potential artifact data)); identifying data points in a received biosignal waveform that are outside the defined waveform range, and designating the identified data points as potential artifact data points (PADP) in paragraph [0625] (identify breathing-related signals for small children and adults, wherein small children have higher breathing rates so their range is on the higher end of the spectral filtering range and adults have lower breathing rates so their range is on the lower end (Examiner notes that an adult breathing-related signal that has a frequency outside of the 0.05-0.5 Hz range will be blocked by the spectral filter and considered potential artifact data points)); setting an earlier occurring PADP in the received biosignal waveform as a first data point DPi, and setting a next successive occurring PADP after the earlier occurring PADP as a second data point DP2 in paragraphs [0689-0690] (calculates a value outside of the specified range for the breathing related signal at least once every 10 seconds during a period of at least 30 seconds, a minute, or an hour (Examiner notes that a data point is established every 10 secs for the duration of the period, therefore DP1 would correspond to the value calculated at 10 seconds and DP2 corresponds to the calculated value at 20 seconds)); determining if data defined by the data points DP1 and DP2 is valid data or artifact data by calculating a time (t) between the two data points DP1 and DP2,comparing the calculated time (t) to a predetermined time (T) in paragraphs [0689-0690] (generates an alert when the values are outside of the specified range (synonymous to artifact data) over 50% of the times they are calculated throughout the period (Examiner notes that the calculated time (t) is synonymous to the time the value is calculated every 10 seconds and compares that to 50% of the period (synonymous to the predetermined time (T)) in order to determine whether to generate an alert for the values that fall outside of the range)), and if (t > T), designating the data points DP1 and DP2, and all data therebetween as valid data in paragraphs [0689-0690] (if the values calculated every 10 seconds are outside of the range less than 50% of times during the period, then the alert is not generated (synonymous to designating the data points and points in between as valid data)); and if (t < T), designating the data points DP1 and DP2, and all data therebetween as artifact data in paragraphs [0689-0690] (if the values calculated every 10 seconds are outside of the range 50% or more of times during the period, then the alert is generated (synonymous to designating the data points and points in between as artifact data)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron, to be combined with cleaning useful data from a biosignal waveform through a series of steps, as disclosed by Halperin, for the purpose of increasing the effectiveness of preventive treatment of abnormal physiological conditions [0011-0012].
As per Claim 13, Aron, Halperin, and Tehrani discloses the system according to claim 12.
Aron does not disclose the following limitations. However, Halperin discloses wherein: the processor is adapted, following a determination as to the validity of a set of data points DP1 and DP2, to determine if there are any further data points that have been designated as PADP in paragraph [0689] (generates an alert when the values are outside of the specified range (synonymous to artifact data) over 50% of the times they are calculated throughout the period (Examiner notes that generating an alert when the values fall outside of the range determines the validity of the data points. Additionally, since the alarm is generated if the values fall outside of the range 50% or more of times during the period indicates that further data points have been deemed as potential artifact data points)), and if there is a further successive occurring PADP, change the data point that was previously set as the second data point DP2 to now be set as the first data point DP1 and set the further successive PADP as the second data point DP2, and repeat the series of steps for cleansing useful data with the newly set data points DP1 and DP2 in paragraphs [0605] and [0625-0626] and [0727] (when the calculated ratio increases over the baseline (synonymous to a further successive occurring PADP), the change between the calculated ratio and baseline is integrated into the score to become the next data point (synonymous to data point DP2) and is repeated to average the signal (synonymous to cleansing useful data) with the calculated ratio and the integrated score (synonymous to the newly set data points DP1 and DP2)); and if there is not any further successive occurring PADP, terminate the cleansing of useful data from the received biosignal waveform in paragraphs [0605] and [0625-0626] and [0727] (when the calculated ratio increase over the baseline is detected, the change between the calculated ratio and baseline is integrated into the score to become the next data point and is repeated to average the signal (Examiner notes that when an increase over a baseline is not detected (synonymous to no further successive occurring PADP), the signal is not averaged (synonymous to terminating the cleansing of useful data from the received biosignal waveform)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron, to be combined with determining if any further data points are PADP, as disclosed by Halperin, for the purpose of increasing the effectiveness of preventive treatment of abnormal physiological conditions [0011-0012].
As per Claim 15, Aron, Halperin, and Tehrani discloses the system according to claim 1.
Aron does not disclose the following limitations. However, Halperin discloses wherein: the input circuitry is adapted to receive biosignals in the form of one or more chosen from: respiratory rates and/or patterns; heart rates and/or patterns; brainwave patterns; muscle contraction patterns; eye movement patterns; partial pressure of oxygen (PaO2); peripheral capillary oxygen saturation (SpO2) patterns; arterial oxygen saturation (SaO2) patterns; percent hemoglobin oxygen saturation patterns; oxygen saturation histogram patterns; blood pressure patterns; body temperature patterns; transcutaneous carbon dioxide tension (tcPCO2) patterns; oxygen tensions (tcPO2) patterns; and electrodermal activity patterns in paragraphs [0604-0605] and [0611] and [0617] and [0627] (the control unit receives biosignal in the form of breathing patterns referred to as respiratory patterns).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron, to be combined with receiving the biosignals in the form of respiratory patterns, as disclosed by Halperin, for the purpose of increasing the effectiveness of preventive treatment of abnormal physiological conditions [0011-0012].
As per Claim 16, Aron, Halperin, and Tehrani discloses the system according to claim 1, Aron further discloses wherein: the treatment protocol comprises a recommended regimen for guiding clinical care of the monitored infant, the recommended regimen comprising one or more clinical interventions chosen from: respiratory support; oxygen support; pharmacological support; nipple flow rate; oral feeding schedule; duration of feeding; volume of oral intake; feeding position; and feeding pace in paragraphs [0032-0033] and [0046] and [0049-0050] and [0053] and [0076] and [0082-0084] and [0101] claim 1 (therapy protocols (synonymous to treatment protocol) includes a recommended regimen for developing strength through therapy (synonymous to guiding clinical care) of the monitored infant, the recommended regimen including therapy with a pacifier, physical stimulation, or repeated therapy with the therapeutic stimulus system for a user (synonymous to a clinical caregiver) to follow for promoting rhythmic motor behaviors (synonymous to predicted outcomes) such as sucking, breathing, mastication, and locomotion for improved oral feeding of the monitored patient (Examiner notes that therapy given through a pacifier, physical stimulation, or through the therapeutic stimulus system are synonymous to clinical interventions, wherein the clinical interventions promote rhythmic motor behaviors such as breathing which is synonymous to respiratory support)).
As per Claim 17, Aron discloses a method for guiding clinical treatments in paragraphs [0009] and [0044] and [0049] (a method for assessing and developing oral feeding capabilities for an infant (synonymous to a method for guiding clinical treatments)), comprising the steps of: providing output circuitry for outputting the treatment protocol in paragraphs [0051] and [0053] (providing a display (synonymous to an output circuitry) display therapy protocols (synonymous to treatment protocol)); wherein the input circuitry is adapted to receive biosignals as measured from the monitored patient in the form of a preterm infant during an oral feeding activity in paragraphs [0046] and [0049] and [0067] and Figure 2 (the input device (synonymous to the input circuitry) receives nutritive sucking patterns (synonymous to biosignals) measured from a monitored preterm infant during an oral feeding); wherein the treatment protocol comprises a recommended regimen for guiding clinical care of the monitored infant, the recommended regimen comprising one or more clinical interventions for a clinical caregiver to follow for promoting a predetermined outcome for improved oral feeding of the monitored infant in paragraphs [0032-0033] and [0046] and [0049-0050] and [0053] and [0076] and [0082-0084] and [0101] claim 1 (therapy protocols includes a recommended regimen for developing strength through therapy (synonymous to guiding clinical care) of the monitored infant, the recommended regimen including therapy with a pacifier, physical stimulation, or repeated therapy with the therapeutic stimulus system for a user (synonymous to a clinical caregiver) to follow for promoting rhythmic motor behaviors (synonymous to predicted outcomes) such as sucking, breathing, mastication, and locomotion for improved oral feeding of the monitored patient (Examiner notes that therapy given through a pacifier, physical stimulation, or through the therapeutic stimulus system are synonymous to clinical interventions)).
Aron discloses receiving biosignals but does not disclose the following limitations. However, Halperin discloses providing input circuitry adapted for receiving biosignals from at least one biosignal sensor that is adapted to transmit biosignals of a monitored patient in paragraphs [0602] and [0604-0605] and [0617] and Figure 2 (providing a control unit (synonymous to an input circuitry) to receive biosignals from at least one biosignal sensor to transmit biosignals of a monitored patient); providing at least one processor adapted for processing received biosignals to generate a treatment protocol for the monitored patient in paragraphs [0605] and [0608] (providing a breathing pattern analysis module (synonymous to at least one processor) processes received biosignals to generate preventive treatment (synonymous to a treatment protocol), wherein the generated treatment corresponds to predicting a clinical event or episode, for the monitored patient).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a method for guiding clinical treatments, as disclosed by Aron, to be combined with an input circuitry that receives biosignals from a sensor and a processor processing the signals to generate a treatment protocol, as disclosed by Halperin, for the purpose of increasing the effectiveness of preventive treatment of abnormal physiological conditions [0011-0012].
Aron and Halperin do not disclose the following limitations. However, Tehrani discloses and wherein the output circuitry is further adapted to control a respiratory support system associated with the monitored patient, based on the recommended regimen, to automate titration of oxygen provided to the monitored patient, so as to ensure a measured oxygen saturation level from the at least one biosignal sensor stays within a predetermined acceptable range in column 1 lines 52-59, column 2 lines 4-21, column 3 lines 9-13, column 4 lines 10-44, column 5 lines 44-50, and column 10 line 65-column 11 line 27 (control a mechanical ventilator (synonymous to a respiratory support system) associated with the monitored patient, based on the recommended regimen, to automatically adjust the oxygen provided to the monitored patient, to ensure the measured oxygen level from the pulse oximeter (synonymous to the at least one biosignal sensor) stays within a predefined acceptable interval).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a method for guiding clinical treatments, as disclosed by Aron and Halperin, to be combined with controlling a respiratory support system, based on the recommended regimen, to automate titration of oxygen to ensure a measured oxygen saturation level stays within a predetermined acceptable range, as disclosed by Tehrani, for the purpose of expediting recovery and reducing mortality and morbidity risks [column 1 lines 21-30].
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Aron et al. (US-20140134585-A1)[hereinafter Aron], in view of HALPERIN et al. (US-20080275349-A1)[hereinafter Halperin], in view of Tehrani (US-8695593-B2)[hereinafter Tehrani], in view of Lau (US-20190216385-A1)[hereinafter Lau].
As per Claim 4, Aron, Halperin, and Tehrani discloses the system according to claim 2.
Aron discloses receiving a biosignal, but does not disclose the biosignals coming from a sensor. However, Halperin discloses wherein: the input circuitry is adapted to receive biosignal waveforms in the form of respiratory waveforms in paragraphs [0604-0605] and [0611] and [0617] and [0627] (the control unit receives biosignal waveforms in the form of breathing patterns referred to as respiratory patterns (synonymous to respiratory waveforms)); and the system further comprises one or more biosignal sensors connected to the input circuitry and adapted for non-invasive monitoring, the one or more biosignal sensors being selected from: a body position sensor; a pulse oximeter; a blood pressure sensor; a temperature sensor; an electromyography (EMG) sensor; an electrocardiogram (ECG) sensor; an airflow sensor; and a galvanic skin response (GSR) sensor in paragraphs [0618] (one or more contact sensors coupled to the control unit for non-invasive monitoring of the monitored patient including a blood oxygen monitor or a pulse oximeter).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron, to be combined with an input circuitry that receives biosignals as respiratory waveforms, as disclosed by Halperin, for the purpose of increasing the effectiveness of preventive treatment of abnormal physiological conditions [0011-0012].
The combination of Aron, Halperin, and Tehrani discloses biosignals sensors used for non-invasive monitoring, but the combination does not disclose the biosignal sensor used to monitor the infant’s biosignals. However, Lau discloses the system further comprises one or more biosignal sensors connected to the input circuitry and adapted for non-invasive monitoring of the monitored infant, the one or more biosignal sensors being selected from: a body position sensor; a pulse oximeter; a blood pressure sensor; a temperature sensor; an electromyography (EMG) sensor; an electrocardiogram (ECG) sensor; an airflow sensor; and a galvanic skin response (GSR) sensor in paragraphs [0075] and [0077] and [0079] and [0106-0107] (the system monitors the oral motor kinetics (synonymous to non-invasive monitoring) of the monitored infant to determine if the infant's feeding problems are due to physiological functions like swallowing, breathing, or upper gastrointestinal function (Examiner notes that sensors are used to monitor the infant in order to determine if physiological functions are causing feeding problems)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron, Halperin, and Tehrani, to be combined with a biosignal sensor monitoring an infant’s biosignals, as disclosed by Lau, for the purpose of improving the infant's safety and competence during oral feeding [0004].
As per Claim 14, Aron, Halperin, and Tehrani discloses the system according to claim 12.
Aron does not disclose the following limitations. However, Halperin discloses wherein: the input circuitry is adapted to receive biosignal waveforms in the form of respiratory waveforms in paragraphs [0604-0605] and [0611] and [0617] and [0627] (the control unit receives biosignal waveforms in the form of breathing patterns referred to as respiratory patterns (synonymous to respiratory waveforms)); the processor is adapted for setting the defined waveform range to encompass respiratory- related movements, with values outside the defined waveform range encompassing non- respiratory movements in paragraphs [0609] and [0625] and [0665] and [0790] and [0849-0850] (setting a spectral filtering range to include respiratory body movements of a patient, with values above of the threshold including non-respiratory body movements of a patient); and the predetermined time (T) is set based on expected durations of non-respiratory movements in paragraphs [0609] and [0665] and [0849-0850] (and the period is set based on the duration of the patient's non-breathing-related motion).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron, to be combined with setting the waveform to encompass respiratory-related movements, and values that are outside of the waveform range are encompassed as non-respiratory movements, as disclosed by Halperin, for the purpose of increasing the effectiveness of preventive treatment of abnormal physiological conditions [0011-0012].
The combination of Aron, Halperin, and Tehrani discloses setting the defined waveform range to encompass respiratory and non-respiratory related movements, but the combination does not disclose the respiratory and non-respiratory movements of an infant. However, Lau discloses the processor is adapted for setting the defined waveform range to encompass respiratory- related movements of an infant, with values outside the defined waveform range encompassing non- respiratory movements of an infant in paragraphs [0075] and [0077] and [0079] (monitors oral motor kinetics (synonymous to non-respiratory movements) of an infant); and the predetermined time (T) is set based on expected durations of an infant's non-respiratory movements in paragraphs [0075] and [0077] and [0079] (monitors oral motor kinetics (synonymous to non-respiratory movements) of an infant).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron and Halperin, to be combined with the non-respiratory movements to be made by infants, as disclosed by Lau, for the purpose of improving the infant's safety and competence during oral feeding [0004].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Aron et al. (US-20140134585-A1)[hereinafter Aron], in view of HALPERIN et al. (US-20080275349-A1)[hereinafter Halperin], in view of Tehrani (US-8695593-B2)[hereinafter Tehrani], in view of Jiang et al. (“Sample entropy analysis of EEG signals via artificial neural networks to model patients' consciousness level based on anesthesiologists experience.”)[hereinafter Jiang].
As per Claim 9, Aron, Halperin, and Tehrani discloses the system according to claim 2.
Aron does not disclose the following limitations. However, Halperin discloses wherein: the processor is adapted to calculate a health score in paragraphs [0608] and [0632] and [0773] and equation 1 (the breathing pattern analysis module derives a score).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron, to be combined with calculating a health score, as disclosed by Halperin, for the purpose of increasing the effectiveness of preventive treatment of abnormal physiological conditions [0011-0012].
The combination of Aron, Halperin, and Tehrani disclose calculating a health score, but does not disclose the SampEn equation. However, Jiang discloses (SampEn) based on the equation
Sample En =
Φ
m
r
=
1
N
-
m
+
1
∑
i
=
1
N
-
m
+
1
log
(
C
i
m
(
r
)
)
in which N represents a length of a total time series of a dataset, m represents the length of a data segment, r represents a pre-established criterion for identifying similarity between data points, and
C
i
m
represents a conditional probability in 2.3 Sample Entropy on page 3 (based on the equation SampEn (m, r, N) = -ln ((Cm+1(r))/(Cm(r)) in which N is the length of the time series, m is the distance between points of a data segment, r represents the tolerable standard deviation of the time series (synonymous to a pre-established criterion for identifying similarity between data points), and C represents a conditional probability (Examiner notes that the equation SampEn (m, r, N) = -ln ((Cm+1(r))/(Cm(r))) is equal to A(m,r) = (1/(N-m+1)* Σ log (C(i,r,m)) according to Sapien Labs)).
It would have been obvious to a person of ordinary skill in the art before the effective filling date of the applicant’s invention of a system for guiding clinical treatments, as disclosed by Aron and Halperin, to be combined with the SampEn equation, as disclosed by Jiang, for the purpose of analyzing EEG signals using the sample entropy (SampEn) analysis [abstract on page 1].
Response to Arguments
Applicant’s arguments, see Page 8, “Claim Objections”, filed 11/07/2025, with respect to claims 5 and 6 have been fully considered and are persuasive. The claim objection of claims 5 and 6 have been withdrawn.
Applicant's arguments, see Pages 8-12, “Rejections under 35 U.S.C. 101” filed 11/07/2025 with respect to claims 1 and 17 have been fully considered and are persuasive. The rejections under 35 U.S.C. 101 have been withdrawn.
Applicant’s arguments, see Page 12, “Rejections under 35 U.S.C. 103”, filed 11/07/2025 with respect to claims 1-16 have been fully considered.
With regards to claims 1-16, Applicant argues that Aron et al., Halperin et al., Lau, nor Jiang et al. disclose nor render obvious the invention as recited in the amended claims. Examiner finds this persuasive. Therefore, the rejection of 08/07/2025 has been withdrawn. However, upon further consideration a new grounds of rejection is made over Aron, in view of Halperin, in view of Tehrani.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
L'Her E, “Automation of oxygen titration in patients with acute respiratory distress at the emergency department” teaches on a device that automatically titrates oxygen flow to maintain the patients in the SpO2 target set by the clinician.
THIS ACTION IS MADE FINAL. 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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/K.N.W./Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682