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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on May 15, 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on May 15, 2063. As directed by the amendment: claims 1, 3-4 have been amended, claim 20 have been canceled, and no claims have been added. Thus, claims 1-19, and 21 are presently pending in the application.
Response to Arguments
Applicant argues on page 7 of the remarks that the 103-rejection that Claim 1. However, Applicant amended the claim to add new limitation “and wherein the system further comprises a humidifier which is configured and designed to warm and humidify the respiratory gas, account being taken of body temperature signals of a temperature sensor at least from time to time or in part for controlling the humidifier in order to warm and humidify the respiratory gas according to the body temperature signals.” , that was not previously considered. Applicant has amended the claim and the new 103 rejection stated below addresses the new limitation of the claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2-4, 11-13 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "at least one sensor is a temperature sensor" in line 2. It is indefinite if Applicant is referring to the same temperature sensor in claim 1 or a different temperature sensor. For the purpose of this Office Action, Examiner is interpreting these are two different temperature sensors. Claims 11-13 are rejected by dependency.
Claims 3-4 recites the limitation "at least one temperature sensor" in line 2. Examiner is unsure if the Applicant is referring to the first temperature sensor in claim 1, or the second temperatures sensor claimed in claim 2. For the purpose of this Office Action, Examiner is interpreting that it is the temperature sensor from claim 2.
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, 5-12, 14, 16 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Burton et al. (US 6349724 B1) in view of Halpern et al. (US 20120132211 A1) and Miller (US 20140283829 A1).
Regarding Claim 1, Burton discloses a system for noninvasive detection during ventilation (“a system” of Fig 1, Col 1 lines 20-21, Fig 1), wherein the system comprises at least one sensor (sensors 71 and/or 80, Col 8 line 26, Fig 1), a ventilator (dual pressure gas delivery device 10, Col 3 lines 21-22, Fig 1), an interface between the ventilator and at least one the sensor (controller or microprocessor 82, Col 6 lines 35-38, Fig 1), a processing unit (computer 200, Col 7 line 23, Fig 1), a data storage unit (“memory capability”, Abstract; Col 8 lines 32-40 supports data storage capability within the microprocessor 82 or computer 200), a user interface (Control panel 110 + keypad 173, Col 8 line 64 – Col 9 line 3 & Col 7 lines 30-35, respectively, Fig 1), an interface to a remote alarm (controller or microprocessor 82, Col 9 lines 14-16, Fig 1), a remote alarm (“alert”, Col 9 lines 15-16 support the microprocessor alerting a health care worker, Col 8 lines 17-18 supports the microprocessor is enabled to remotely communicate via telemetry, Fig 3), a ventilation tube (dual pressure hose 50, Col 5 line 41, Fig 1) having a patient interface (mask 70, Col 5 line 44, Fig 1), and at least one respiratory gas sensor (71, Col 8 line 26, Fig 1), the ventilator being configured to identify pressure and/or flow of respiratory gas by means of at least one respiratory gas sensor (71, Col 8 line 26, Fig 1; col 8 lines 26-32 support sensor types including those for mask pressure or mask leak detection) and to convey pressurized respiratory gas (Col 1 lines 37-40) and the system being configured to ascertain a sensor signal by means of the at least one sensor and the processing unit (Col 6 lines 27-29, further supported by Col 7 line 23 wherein computer 200 may program microprocessor 82), at least in phases during ventilation, and the ability to check whether the sensor signal is representative of an abnormal physiological parameter (Col 2 lines 4-9 support monitoring and analyzing sensor data to determine if parameters warrant an alert), wherein the system further comprises a humidifier (humidifier 55; Fig. 1) which is configured and designed to warm and humidify the respiratory gas (Col. 3 line 64- Col. 4 line 22; This limitation is functional the humidifier is configured to warm gas).
Burton fails to teach detection of an infection, at least one sensor configured for detection of an infection, and to check whether the sensor signal is representative of an infection.
However, Halpern teaches detection of an infection ([0601] lines 5-8 support rise in body temperature as an indicator of infection), at least one sensor configured for detection of an infection (temperature sensor 80, [0601], Fig 2), and to check whether the sensor signal is representative of an infection ([0099] lines 6-11).
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 system for noninvasive detection during ventilation with programmable processing capabilities, as taught by Burton, to incorporate the ability to detect infection via detecting a rise in body temperature, as taught by Halpern, in order to provide early warning to the patient or a health care provider, enabling swift action to adjust treatment, to prevent further deterioration or sequelae.
Modified Burton does not specifically teach account being taken of body temperature signals of a temperature sensor at least from time to time or in part for controlling the humidifier in order to warm and humidify the respiratory gas according to the body temperature signals.
However, Miller teaches account being taken of body temperature signals of a temperature sensor (Fig. 3; 44; para. 0073, 0076) at least from time to time or in part (this limitation is functional) for controlling the humidifier in order to warm and humidify the respiratory gas according to the body temperature signals (para. 0028, 0076).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Burton to include the a temperature sensor and controller to account being taken of body temperature signals of a temperature sensor at least from time to time or in part for controlling the humidifier in order to warm and humidify the respiratory gas according to the body temperature signals as taught by Miller for the purpose of in order to achieve a desired temperature and/or humidification of the respiratory gas supplied to a patient via the gas delivery system (para. 0028) and achieve the desired level of operation (para. 0076).
Regarding Claim 2, Modified Burton teaches the system of claim 1, Burton discloses wherein the sensor (80; Fig 1) is a temperature sensor (80, Col 8 lines 26-29, Fig 1).
Halpern further teaches a temperature sensor (temperature sensor 80, [0601], Fig 2) which detects a rise in body temperature as an infection ([0601] lines 5-8) when defined threshold values are reached or exceeded ([0116]-[0118]).
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 purpose of the temperature sensor, as taught by Burton in view of Halpern, to detect a rise in body temperature outside of a pre-determined range as an infection, as taught by Halpern, in order to immediately alert the patient or a health care worker of a change in patient condition that requires attention and potentially treatment, to prevent deterioration of the patient receiving ventilation support.
Regarding Claim 3, Modified Burton teaches the system of claim 2,
Modified Burton does not specifically further disclose wherein the at least one temperature sensor is a thermistor.
However, Miller teaches wherein the at least one temperature sensor is a thermistor (para. 0055).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the temperature sensor of Modified Burton to include that it is a thermistor as taught by Miller for the purpose of the sensor being able to be located immediately beneath the surface of the device and held adjacent, in thermal contact with, tissues in the vicinity of the junction between the esophagus and trachea (para. 0055).
Regarding Claim 5, Modified Burton teaches the system of claim 1, wherein the at least one sensor (71/80) is provided in the ventilation tube (50; Fig 1) or the patient interface (70; Col 5 line 60 supports and Fig 1 depicts sensor location inside of mask) for measurement of the temperature of inspiration flow and/or expiration flow (Col 7 lines 35-38 supports control of settings related to the characteristics of the pressurized air applied to the patient (i.e.: inspiration flow) including temperature, therefore inherently indicating the need for temperature data measurement within the patient respiratory circuit and reception to ensure comfort settings are met).
Regarding Claim 6, Modified Burton teaches the system of claim 1, Burton further discloses wherein the at least one sensor (80) is arranged adjacent to a body or skin of a patient (Col 5 lines 60-61 supports sensor 80 placed on patient 100, Fig 1).
Regarding Claim 7, Modified Burton teaches the system of claim 1, Burton further discloses wherein an activity sensor (Col 9 lines 4-6) is provided in addition to the at least one sensor (80).
Regarding Claim 8, Modified Burton teaches the system of claim 1, Burton further discloses wherein the transmission of sensor data via the interface (82) between the ventilator (dual pressure gas delivery device 10, Col 3 lines 21-22, Fig 1), and sensor (sensors 71 and/or 80, Col 8 line 26-45, Fig 1) takes place at least daily (Col 1 lines 61-67; support the ability to obtain sensor information and make adjustments in real time, which is more frequently than at a daily rate).
Regarding Claim 9, Modified Burton teaches the system of claim 1, (wherein the processing unit (200) is designed and configured to detect whether a sensor signal is present and whether a sensor signal represents a temperature signal (Col 6 lines 27-29 supports the ability of a sensor to send a signal to the microprocessor for analysis and a programmed responsive action based on the signal(s) received, further supported by Col 8 lines 17-20 wherein computer 200 can program microprocessor 82; Col 8 lines 26-29 supports the ability of a sensor to retrieve and transmit temperature data; Col 1 lines 54-67 further supports monitoring multiple sensors and using those data points to adjust treatment parameters, be stored for diagnosis and study, or to alert a health care worker abut a patient’s condition that requires immediate attention, thus demonstrating the ability to differentiate sensor signals, inclusive of a signal indicating temperature).
Regarding Claim 10, Modified Burton teaches the system of claim 1, Burton further discloses wherein the processing unit (200) is designed and configured to process the sensor signal (Col 8 lines 32-38 supports processing the sensor data received; Col 8 lines 17-20 support wherein computer 200 can program microprocessor 82), and to save it in the data storage unit (Col 8 lines 32-40 supports data storage capability within the microprocessor 82 or computer 200).
Regarding Claim 11, Modified Burton teaches the system of claim 2, Burton further discloses wherein the processing unit (200) is designed and configured to compare a temperature signal with stored alarm thresholds (Col 8 lines 26-29 supports the ability of a sensor to retrieve and transmit temperature data. Col 6 lines 27-29 supports the ability of a sensor to send a signal to the microprocessor for analysis and a programmed responsive action based on the signal(s) received. Col 8 lines 17-20 support wherein the computer 200 can program microprocessor 82, and further, Col 7 lines 39-42 support the ability of settings to be stored within the microprocessor or computer for individualized treatment of the patient (i.e.: storing alarm threshold settings for various sensors); Col 2 lines 4-9 support a microprocessor programmed to evaluate the data from the sensors and alert health care workers of the patient’s condition. An alert would indicate the data was evaluated to be outside of a predetermined normal range.).
Halpern further teaches wherein the processing unit (control unit 14, [0116], Fig 2) is designed and configured to compare a temperature signal (data received from temperature sensor 80, [0601], Fig 2) with stored alarm thresholds (“specified range of values for the physiological parameter” (i.e.: temperature is a physiological parameter), [0117], Fig 2; [0118] supports analyzing whether the sensed physiological parameter falls outside of the specified range), and the alarm thresholds representing an excessively high temperature or low temperature ([0118] supports generating an alert upon analyzing that the sensed physiological parameter falls outside of the specified range (i.e.: high or low temperature); Examiner notes: given the alternative presentation of claim 11, Examiner supports alarm thresholds representing an excessively high temperature).
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 ability to program alarm thresholds, as taught by Burton in view of Halpern, to further incorporate that the alarm thresholds indicate excessively high or low temperature, as further taught by Halpern, in order to provide a first screening indication of an infection developing within the patient ([0601]) by means of an alert to a healthcare worker enabling early intervention.
Regarding Claim 12, Modified Burton teaches the system of claim 2, Burton further discloses wherein the processing unit (200) is designed and configured to compare a temperature signal with stored alarm thresholds (Col 8 lines 26-29 supports the ability of a sensor to retrieve and transmit temperature data. Col 6 lines 27-29 supports the ability of a sensor to send a signal to the microprocessor for analysis and a programmed responsive action based on the signal(s) received. Col 8 lines 17-20 support wherein the computer 200 can program microprocessor 82, and further, Col 7 lines 39-42 support the ability of settings to be stored within the microprocessor or computer for individualized treatment of the patient (i.e.: storing alarm threshold settings for various sensors); Col 2 lines 4-9 support a microprocessor programmed to evaluate the data from the sensors and alert health care workers of the patient’s condition. An alert would indicate the data was evaluated to be outside of a predetermined normal range.). Burton also discloses in the event of an alarm threshold being exceeded, is designed and configured to control at least one ventilation parameter of the ventilator (Col 2 lines 4-9 supports the ability of the microprocessor’s programming {programmed by the computer 200, Col 8 lines 17-20} to evaluate the sensed data to make changes to the air pressure applied to the patient, and the timing thereof, further supported by Col 8 lines 4-7) resulting in a ventilation matched to the increased body temperature.
Halpern further teaches wherein the processing unit (control unit 14, [0116], Fig 2) is designed and configured to compare a temperature signal (data received from temperature sensor 80, [0601], Fig 2) with stored alarm thresholds (“specified range of values for the physiological parameter” (i.e.: temperature is a physiological parameter), [0117], Fig 2; [0118] supports analyzing whether the sensed physiological parameter falls outside of the specified range), and the alarm thresholds representing an excessively high temperature or low temperature ([0118] supports generating an alert upon analyzing that the sensed physiological parameter falls outside of the specified range (i.e.: high or low temperature); Examiner notes: given the alternative presentation, Examiner supports alarm thresholds representing an excessively high temperature).
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 ability to program alarm thresholds, as taught by Burton in view of Halpern, to further incorporate that the alarm thresholds indicate excessively high or low temperature, as further taught by Halpern, in order to provide a first screening indication of an infection developing within the patient ([0601]) by means of an alert to a healthcare worker enabling early intervention.
Regarding Claim 14, Modified Burton teaches the system of claim 1, Burton further discloses wherein the processing unit (200) is designed and configured to form statistics (Col 8 lines 38-44; Merriam-Webster defines statistics as a collection of quantitative data) and to save them in the data storage unit (Col 8 lines 38 supports data storage capability of the computer 200).
Regarding claim 16, Modified Burton teaches the system of claim 1, Burton further discloses wherein the data storage unit (“memory capability”, Abstract; Col 8 lines 32-40 supports data storage capability within the microprocessor 82 or computer 200) is designed and configured to record (“record”, Abstract 3rd line from bottom), in a retrievable manner, a course of the sensor signal (Col 2 lines 7-9).
Regarding Claim 18, Modified Burton teaches the system of claim 1, Burton further teaches wherein the interface to the remote alarm (microprocessor 82, Col 9 lines 14-16, Fig 1) is designed and configured to conduct either data only or data and power in relation to the remote alarm (Col 9 lines 14-17 support conduction of sensor data to alert a heath care worker, Col 8 lines 32-38 support telemetry capability for transmitting data to a remote computer for monitoring by health care workers).
Regarding Claim 19, Modified Burton teaches the system of claim 1, Burton further discloses wherein the interface to the remote alarm (microprocessor 82, Col 9 lines 14-16, Fig 1) is configured and designed for at least daily transmission (Col 1 lines 61-67 support the ability to obtain sensor information and make adjustments in real time, which is more frequently than at a daily rate).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Burton in view of Halpern and Miller, as applied to claim 2, in further view of Viveiros (US 20200338304 A1).
Regarding Claim 4, Modified Burton teaches the system of claim 2,
Modified Burton does not teach that wherein at least one temperature sensor is a thermal imaging camera.
However, Viveiros teaches wherein at least one temperature sensor is a thermal imaging camera (para. 00061).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one sensor, as taught by Modified Burton, to be a thermal imaging camera, as taught by Viveiros, for the purpose of estimating body temperature non-intrusively.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Burton in view of Halpern, and Miller, as applied to claim 2, in further view of Chausiaux et al. (US 2018/0192873 A1).
Regarding Claim 13, Modified Burton teaches the system of claim 2, Burton further discloses wherein the processing unit (200) is designed and configured to compare a temperature signal with stored alarm thresholds (Col 8 lines 26-29 supports the ability of a sensor to retrieve and transmit temperature data. Col 6 lines 27-29 supports the ability of a sensor to send a signal to the microprocessor for analysis and a programmed responsive action based on the signal(s) received. Col 8 lines 17-20 support wherein the computer 200 can program microprocessor 82, and further, Col 7 lines 39-42 support the ability of settings to be stored within the microprocessor or computer for individualized treatment of the patient (i.e.: storing alarm threshold settings for various sensors); Col 2 lines 4-9 support a microprocessor programmed to evaluate the data from the sensors and alert health care workers of the patient’s condition. An alert would indicate the data was evaluated to be outside of a predetermined normal range.).
Modified Burton fails to teach in the event of an alarm threshold for an increased or decreased body temperature being exceeded (temperature alarm), the processing unit is designed and configured to request, in an automated manner, feedback from a patient, said feedback being a digital response from the patient that represents a current state and/or is designed and configured to output recommended actions to the patient via an end-user interface or a loudspeaker.
However, Chausiaux teaches in the event of an alarm threshold for an increased or decreased body temperature being exceeded (temperature alarm) {exceeding the threshold 60 may be sufficient to trigger an alert, [0048-0049], Fig 4}, the processing unit (data centre, [0047]) is designed and configured to request, in an automated manner, feedback from a patient, said feedback being a digital response from the patient that represents a current state ([0046] indicates “displaying a message asking a subject to indicate how they feel on a scale from 1 to 10. The user may input a response and that input may form an input to the algorithm that estimates the likelihood of disease.”; It is reasonable and well within the skill of the art to display this prompt automatically, as protocol, in response to sensor data exceeding a pre-determined threshold) and/or is designed and configured to output recommended actions to the patient via an end-user interface or a loudspeaker (Examiner note: given the alternative presentation, prior art supports the former condition).
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 programmed response to an alarm threshold, as taught by Burton in view of Halpern, to incorporate an automated prompt for patient feedback regarding current condition, as taught by Chausiaux, in order to analyze subjective data in combination with objective sensor output data to better estimate the likelihood of disease or disease progression within a monitored patient ([0046]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Burton in view of Halperin and Miller, as applied to claim 7, in view of Nijman et al. (BMJ 2012;344:e4224, Published 3 July 2012); hereafter as Nijman.
Regarding Claim 15, Modified Burton teaches the system of claim 7, Burton further discloses wherein the processing unit (200) is designed and configured to process signals of the at least the sensor and signals of the at least one respiratory gas sensor and signals of the activity sensor (Col 8 lines 26-36; Col. 9 lines 4-9 support processing data from such various sensors)
Modified Burton does not specifically disclose to compare signals of the at least one sensor by a comparison with signals of the at least one respiratory gas sensor and/or signals of the activity sensor.
However, Nijman teaches comparing body temperature and respiratory rate of children to predict the presence of lower respiratory tract infections (Abstract; page 3 discussion; page 8 table 1).
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 sensors and system of the modified Burton to be able to take the measures of a person body temperature and respiratory rate and compare them as taught by Nijman as an additional means to detect an infection (discussion; page 3-4; Conclusion page 1).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Burton in view of Halpern and Miller, as applied to claim 1, in further view of Boyer et al. (US 2015/0018648 A1).
Regarding Claim 17, Modified Burton teaches the system of claim 1, Burton discloses the user interface (Control panel 110 + keypad 173, Col 8 line 64 – Col 9 line 3 & Col 7 lines 30-35, respectively, Fig 1)
Burton fails to teach a user interface that is designed and configured to generate feedback as to whether the at least one sensor has been connected correctly and is providing values or not.
However, Boyer teaches a user interface (UI 218, [0023], Fig 2) that is designed and configured to generate feedback as to whether a sensor has been connected correctly and is providing values or not ([0023] supports 218 outputting processed sensor information in a visual display in graphical and/or numerical forms as generated feedback, [0041] supports user preference in regard to the which data is displayed by the user interface 218, Fig 5; It is inherent that if a sensor is not correctly connected, the sensor output display would demonstrate a significant variation from an expected value range or even not register a signal and lack any visual output, thus tipping off the user that there is an issue with that sensor’s connection quality.).
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 visual display output of processed sensor information through the user interface of a ventilation system, as taught by Burton in view of Halpern, to incorporate graphical displays of ongoing sensor readings, as taught by Boyer, in order to demonstrate appropriate sensor connection quality as well as to visually indicate current and trending patient data, system parameters, and alerts.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Burton in view of Halpern and Miller, as applied claim 1, in further view of Crosbie et al. (US 20220126072 A1).
Regarding Claim 21, Modified Burton teaches the system of claim 1, wherein the ventilator (dual pressure gas delivery device 10, Col 3 lines 21-22; Col 9 lines 18-26) Fig 1) is configured to determine a respiratory rate (air flow rate; Col 9 lines 18-26), the determined respiratory rate being linked to at least one sensor signal (controller or microprocessor 82, Col 6 lines 35-38, Fig 1),
Burton does not specifically disclose a possible infection or a probability of an infection being ascertained by means of the linked respiratory rate and the at least one sensor signal.
Crosbie teaches a possible infection or a probability of an infection (para. 0074) being ascertained by means of the linked respiratory rate (para. 0074 and 0121) and the at least one sensor signal (sensors 80; Fig. 4; para. 0074, 0121, 0123).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify sensor signal as taught by Burton in view of Halpern, to incorporate a possible infection or a probability of an infection (para. 0074) being ascertained by means of the linked respiratory rate (para. 0074 and 0121) and the at least one sensor signal (sensors 80; Fig. 4; para. 0074, 0121, 0123), as taught by Crosbie, in order to demonstrate appropriate sensor means of an alert to a healthcare worker enabling early intervention (0121).
Conclusion
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/MAAP AHMED ELLABIB/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785
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