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 .
Claim Objections
Claims 8, 11, 12, 29, 33, 45, 53, 55, 70, and 74 are objected to because of the following informalities:
The limitation “the device comprises” in line 1 of claims 8 and 11, should read “the device further comprises”.
The limitation “comprising a” in line 1 of claims 29 and 33, should read “further comprising a”.
The limitation “pressure sensor comprises” in line 1 of claims 12 and 55, should read “pressure sensor further comprises”.
The limitation “Return of” in line 2 of claim 45, should read “return of”.
The limitation “the system comprises” in line 1 of claim 53, should read “the system further comprises”.
The limitation “claim 50, comprising” in line 1 of claim 70 and 74, should read “claim 50, further comprising”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 16, 20, 29, 33, and 44-48 are rejected under 35 U.S.C. 103 as being unpatentable over Campana (US 20170266399 A1), in view of Acker (US 20150273176 A1) and Gallagher (US 5529093 A).
Regarding claim 1, Campana discloses a sensing device for use in ventilation treatment (FIGS. 6-18 a flow sensor system 100 as set forth in [0170]), comprising: a gas flow conduit configured to be coupled with a patient airway (The flow sensor system comprises a flow conduit configured to be placed in a patient airway and having a lumen that accommodates gas flow as set forth in [0008], FIG. 9(a) Lumen 102 of the flow conduit 101 as set forth in [0174]); a means for measuring a flow of gas inside the conduit (FIG. 7 A flow restrictor 105 is disposed within the lumen 102 of the flow conduit 101 between the first region 103 and the second region 104 so as to extend across all or a portion of the lumen 102 in order to obstruct the flow of gas through the lumen between the first region 103 and the second region 104 and create a pressure drop in the flow, which can be measured to calculate a flow rate and/or volume of the gas passing through the flow conduit 101 as set forth in [0171]); at least one pressure sensor configured for measurement of a pressure inside of the conduit (FIG. 9(a) First absolute pressure sensor 131 disposed adjacent to the first region 103 as set forth in [0176]), wherein the pressure inside of the conduit reflects a patient airway pressure (The flow sensor system comprises a flow conduit configured to be placed in a patient airway and having a lumen that accommodates gas flow as set forth in [0008], indicating the pressure inside the conduit reflects a patient airway pressure); wherein the sensing device is configured to output signals for use in: determining at least one waveform associated with a value of at least one ventilatory parameter over time (FIG. 41 depicts a series of graphs that show the absolute pressure, pressure differential and flow rate detected over time by the flow sensor system for a spontaneously breathing patient as set forth in [0295]; Additionally, the flow sensor system further comprises a processor, configured to send a signal displaying physiological data of the patient (e.g., vitals information) and resuscitative information to a user (e.g., feedback to adjust the gas flow through the lumen of the flow conduit, or other instructions, the physiological data may include at least one of ECG (Electrocardiography) data, SpO2 data, EtCO2 data, blood pressure, heart rate, temperature, SmO2 and muscle pH of the patient, or other physiological information as set forth in [0012]; the device having one or more additional sensors that may be used to sense the relative concentration of gas flowing through the conduit, e.g., oxygen, carbon dioxide concentration, as set forth in [0217]; For example, FIGS. 49(a) and 49(b) show the expired CO2 tension versus exhaled volume, wherein including dynamic lung compliance in the calculation of overall lung volume using SBCO2 curves may enhance the accuracy produced by SBCO2-based calculations as set forth in [0317]); and based at least in part on one or more morphological features of the at least one waveform, determine at least one current condition of the patient or at least one current condition relating to treatment of the patient (FIG. 41 Such a flow profile may also be indicative of a patient who is experiencing agonal respiration, which is generally characterized by an abnormal pattern of breathing and may include gasping, labored breathing, accompanied by irregular vocalization and/or myoclonus. In a spontaneous breath, because air is drawn in due to negative pressure generated by downward movement of the diaphragm, the absolute pressure senses an initial decrease during inspiration, followed by an increase in pressure during expiration as set forth in [0259]; when the system detects an initial negative pressure change and a threshold level of flow rate or volume, the system may provide an indication to the rescuer or other device that the patient may be undergoing spontaneous breathing. This information, while not conclusive, may be further useful in providing a rescuer with an indication that the patient may be experiencing return of spontaneous circulation (ROSC). For example, the system may provide a display to the rescuer of “Possible ROSC” and/or may provide appropriate instructions/guidance as set forth in [0296]; By determining the type of breath that is occurring, rescuers can be alerted whether the patient has begun spontaneous breathing and adjust the treatment protocol accordingly. For instance, for a spontaneously breathing patient, the rescuer may adjust how much additional ventilator support is necessary to give above what the patient is generating on their own. That is, when the patient is spontaneously breathing, the amount of pressure support assisted by manual or automated ventilation may be appropriately reduced. For example, the better the patient is able to breathe, the less pressure support may be required by positive pressure ventilation as set forth in [0299]; Additionally, the EtCO2 measurements can be used to confirm placement of the endotracheal tube as set forth in [0226] and [0229] or provide recommendations to titrate ventilation rate to achieve a particular end tidal CO2 value as set forth in [0307], and based on the SBCO2 curve, calculations can be made to determine both alveolar as well as non-alveolar deadspace based on techniques known to those skilled in the art, the sum of these two deadspaces does not produce any gas exchange in the patient, so this sets the minimum ventilation volume for each patient as set forth in [0315]-[0317], the minimum ventilation being used as further shown in FIG. 45(b), when the dashboard prompts the user to ventilate, the volume indication (numerical value and bar graph) resets and provides the ventilation volume when the breath is applied. FIG. 45(c) shows the ventilation volume to be 800 mL, which falls outside of the specified range. Accordingly, the dashboard provides an indication to the user that the patient has been overventilated. This may provide a signal to the user to lessen the ventilation volume of the next positive pressure breath as set forth in [0308]; the minimum ventilation calculated via the waveforms being current condition of the patient or at least one current condition relating to treatment of the patient).
Campana fails to explicitly disclose, wherein a thermal mass flow sensor is disposed at least in part inside of the conduit, configured for measurement of a flow of gas inside of the conduit.
However, Acker teaches, wherein a thermal mass flow sensor is disposed at least in part inside of the conduit, configured for measurement of a flow of gas inside of the conduit (Acker: FIG. 4A-B bi-directional BCG flow sensor 402 can be a thermal mass flow meter capable of measuring flow in both the forward and reverse direction without substantially interfering with flow and/or pressure in the patient breathing circuit as set forth in [0079]-[0080]).
Campana and Acker are both considered to be analogous to the claimed invention because they are in the same field of the delivery of breathing gas to patients in need thereof. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Campana to incorporate the teaching of Acker and include, wherein a thermal mass flow sensor is disposed at least in part inside of the conduit, configured for measurement of a flow of gas inside of the conduit (Acker: FIG. 4A-B bi-directional BCG flow sensor 402 can be a thermal mass flow meter capable of measuring flow in both the forward and reverse direction without substantially interfering with flow and/or pressure in the patient breathing circuit as set forth in [0079]-[0080]). Doing so would provide a means for measuring flow in both the forward and reverse direction without substantially interfering with flow and/or pressure in the patient breathing circuit (e.g., as flow and/or pressure in the breathing circuit can be extremely precise and important for treating the patient) that provides a substantially fast response time (Acker: As set forth in [0080]).
Campana as modified fails to explicitly disclose at least one flow conditioner configured to condition the flow of the gas inside of the conduit.
However, Gallagher teaches a flow conditioner configured to condition the flow of the gas inside of the conduit (Gallagher: FIGS. 11-12 A flow conditioner for use in pipelines to isolate a measuring device from the effects of piping induced disturbances thereby allowing more accurate metering of fluids flowing in pipelines as set forth in the Abstract and column 8 lines 37-54).
Campana and Gallagher are both considered to be analogous to the claimed invention because they are in the same field of tubular conduits delivering gas. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inlet of the conduit of the sensing device of Campana to incorporate the teaching of Gallagher and include, a flow conditioner configured to condition the flow of the gas inside of the conduit (Gallagher: FIGS. 11-12 A flow conditioner for use in pipelines to isolate a measuring device from the effects of piping induced disturbances thereby allowing more accurate metering of fluids flowing in pipelines as set forth in the Abstract and column 8 lines 37-54). Doing so would condition the flow to allow for a more accurate metering of fluids flowing in pipeline (Gallagher: As set forth in the Abstract and column 8 lines 37-54).
Regarding claim 16, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Campana as modified further discloses, wherein the device is configured to provide sensed flow rate data relating to the flow of the gas inside of the conduit and sensed pressure data relating to the pressure inside of the conduit for use in determining ventilation feedback and chest compression feedback (FIG. 44 provides a flow chart illustrating an embodiment of the process through which a system may utilize information provided from the flow sensor. As shown, the system may detect whether flow is occurring through the conduit based on whether a threshold flow rate or volume has been met. If flow has been detected, then a user interface or display provided by a device of the system or monitor thereof, may enter into a mode that accounts for ventilation parameters. For example, in response to flow detection, the device may produce a ventilation dashboard displayed on a screen thereof. In some embodiments, an overall CPR dashboard may be displayed, which has a chest compression dashboard portion and a ventilation dashboard portion, as appropriate for the type of treatment(s) to be provided, when manual ventilations are detected, the system may sense when the patient is just beginning a spontaneous inspiratory breath, and immediately prompt the rescuer to administer a manual ventilation so that the positive pressure breath is provided as air is being pulled into the lungs; ventilation prompts may be provided according to a timed rate such as in the case of a continuous breath protocol, or ventilation prompts may be provided according to the number of chest compressions that have been administered; for example, the system may countdown the number of chest compression that have occurred and prompt the rescuer to vent when the countdown has finished as set forth in [0302]-[0305]).
Regarding claim 20, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Campana as modified further discloses, wherein the device is configured to provide sensed flow rate data and sensed pressure data for use in determining bag valve mask ventilation feedback, wherein the bag valve mask ventilation feedback relates to at least one of: a breath rate and a volume relating to the bag valve mask ventilation (As set forth in [0302]-[0311]; Specifically, FIGS. 47(a) and 47(b) show similar information as that provided above with respect to ventilation volume, breath rate and countdown information to the next breath as set forth in [0311], in which the system may utilize information provided from the flow sensor to display on a chest compression dashboard portion and a ventilation dashboard portion, an appropriate type of treatment(s) to be provided as set forth in [0302]).
Regarding claim 29, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Campana as modified by Acker further teaches the device, comprising a carbon dioxide sensor for sensing carbon dioxide in the gas inside of the conduit, wherein the conduit, the thermal mass flow sensor (As modified above for claim 1 by Acker), the at least one pressure sensor and the carbon dioxide sensor are fixed relative to each other (one or more additional sensors may be used to sense the relative concentration of gas flowing through the conduit (e.g., oxygen, carbon dioxide concentration as set forth in [0217]; the conduit, the thermal mass flow sensor, the at least one pressure sensor and the carbon dioxide sensor are fixed relative to each other in respect to the way that the sensors are all measuring the gas directly from the conduit and are therefore relative to each other).
Regarding claim 33, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Campana as modified further discloses, the device, comprising a connection adapter configured for facilitating electrical connection of the device to a medical device, wherein the connection adapter is rotatable relative to the conduit (See Campana FIG. 6-9 and 16-18 The protuberances 147 on the snap arms 109 engage within the indentation 140 on the housing 138 to maintain the engagement between the connector 113 and the snap arms 109 while allowing the connector 113 to rotate with respect to the flow conduit 101 without becoming disengaged and allowing the connector 113 to be coupled to the flow conduit 101 from a variety of angular orientations as set forth in [0231], [0233], and [0236]; the connector 113 for establishing communication between any suitable medical devices as set forth in [0269]).
Regarding claim 44, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Campana as modified further discloses, wherein the at least one ventilatory parameter comprises at least one concentration of at least one of: carbon dioxide (See Campana FIG. 49(a) - 49(b) The flow sensor system further comprises a processor, configured to send a signal displaying physiological data of the patient (e.g., vitals information) and resuscitative information to a user (e.g., feedback to adjust the gas flow through the lumen of the flow conduit, or other instructions, the physiological data may include at least one of ECG (Electrocardiography) data, SpO2 data, EtCO2 data, blood pressure, heart rate, temperature, SmO2 and muscle pH of the patient, or other physiological information as set forth in [0012]; the device having one or more additional sensors that may be used to sense the relative concentration of gas flowing through the conduit, e.g., oxygen, carbon dioxide concentration, as set forth in [0217]; For example, FIGS. 49(a) and 49(b) show the expired CO2 tension versus exhaled volume, wherein the EtCO2 measurements can be used to confirm placement of the endotracheal tube as set forth in [0226] and [0229] or provide recommendations to titrate ventilation rate to achieve a particular end tidal CO2 value as set forth in [0307], and based on the SBCO2 curve, calculations can be made to determine both alveolar as well as non-alveolar deadspace based on techniques known to those skilled in the art, the sum of these two deadspaces does not produce any gas exchange in the patient, so this sets the minimum ventilation volume for each patient as set forth in [0315]-[0317], the minimum ventilation being used as further shown in FIG. 45(b), when the dashboard prompts the user to ventilate, the volume indication (numerical value and bar graph) resets and provides the ventilation volume when the breath is applied. FIG. 45(c) shows the ventilation volume to be 800 mL, which falls outside of the specified range. Accordingly, the dashboard provides an indication to the user that the patient has been overventilated. This may provide a signal to the user to lessen the ventilation volume of the next positive pressure breath as set forth in [0308]; the minimum ventilation calculated via the waveforms being current condition of the patient or at least one current condition relating to treatment of the patient).
Regarding claim 45, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Campana as modified further discloses, wherein the at least one current condition of the patient comprises at least one of: spontaneous breathing, Return of spontaneous circulation (ROSC) and agonal breathing (FIG. 41 Such a flow profile may also be indicative of a patient who is experiencing agonal respiration, which is generally characterized by an abnormal pattern of breathing and may include gasping, labored breathing, accompanied by irregular vocalization and/or myoclonus. In a spontaneous breath, because air is drawn in due to negative pressure generated by downward movement of the diaphragm, the absolute pressure senses an initial decrease during inspiration, followed by an increase in pressure during expiration as set forth in [0259]; when the system detects an initial negative pressure change and a threshold level of flow rate or volume, the system may provide an indication to the rescuer or other device that the patient may be undergoing spontaneous breathing. This information, while not conclusive, may be further useful in providing a rescuer with an indication that the patient may be experiencing return of spontaneous circulation (ROSC). For example, the system may provide a display to the rescuer of “Possible ROSC” and/or may provide appropriate instructions/guidance as set forth in [0296]; By determining the type of breath that is occurring, rescuers can be alerted whether the patient has begun spontaneous breathing and adjust the treatment protocol accordingly. For instance, for a spontaneously breathing patient, the rescuer may adjust how much additional ventilator support is necessary to give above what the patient is generating on their own. That is, when the patient is spontaneously breathing, the amount of pressure support assisted by manual or automated ventilation may be appropriately reduced. For example, the better the patient is able to breathe, the less pressure support may be required by positive pressure ventilation as set forth in [0299]).
Regarding claim 46, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Campana as modified further discloses, wherein the at least one current condition relating to treatment of the patient relates to at least one of: providing of bag valve mask (BVM) ventilation and providing of chest compressions (As set forth in [0146] and [0302]-[0311]; Specifically, FIGS. 47(a) and 47(b) show similar information as that provided above with respect to ventilation volume, breath rate and countdown information to the next breath as set forth in [0311], in which the system may utilize information provided from the flow sensor to display on a chest compression dashboard portion and a ventilation dashboard portion, an appropriate type of treatment(s) to be provided as set forth in [0302]).
Regarding claim 47, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Campana as modified further discloses, wherein the at least one current condition relating to treatment of the patient relates to at least providing of mechanical chest compressions without the use of an ITD or ACD device (An overall CPR dashboard may be displayed, which has a chest compression dashboard portion and a ventilation dashboard portion, as appropriate for the type of treatment(s) to be provided, when manual ventilations are detected, the system may sense when the patient is just beginning a spontaneous inspiratory breath, and immediately prompt the rescuer to administer a manual ventilation so that the positive pressure breath is provided as air is being pulled into the lungs; ventilation prompts may be provided according to a timed rate such as in the case of a continuous breath protocol, or ventilation prompts may be provided according to the number of chest compressions that have been administered; for example, the system may countdown the number of chest compression that have occurred and prompt the rescuer to vent when the countdown has finished as set forth in [0302]-[0305], the CPR dashboard may include a chest compression dashboard, for tracking parameters useful for providing quality chest compressions as set forth in [0323]).
Regarding claim 48, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 47 above.
Campana as modified further discloses, wherein the at least one morphological condition comprises at least a negative pressure associated with a patient airway pressure waveform (FIG. 41 Such a flow profile may also be indicative of a patient who is experiencing agonal respiration, which is generally characterized by an abnormal pattern of breathing and may include gasping, labored breathing, accompanied by irregular vocalization and/or myoclonus. In a spontaneous breath, because air is drawn in due to negative pressure generated by downward movement of the diaphragm, the absolute pressure senses an initial decrease during inspiration, followed by an increase in pressure during expiration as set forth in [0259]; when the system detects an initial negative pressure change and a threshold level of flow rate or volume, the system may provide an indication to the rescuer or other device that the patient may be undergoing spontaneous breathing. This information, while not conclusive, may be further useful in providing a rescuer with an indication that the patient may be experiencing return of spontaneous circulation (ROSC). For example, the system may provide a display to the rescuer of “Possible ROSC” and/or may provide appropriate instructions/guidance as set forth in [0296]; By determining the type of breath that is occurring, rescuers can be alerted whether the patient has begun spontaneous breathing and adjust the treatment protocol accordingly. For instance, for a spontaneously breathing patient, the rescuer may adjust how much additional ventilator support is necessary to give above what the patient is generating on their own. That is, when the patient is spontaneously breathing, the amount of pressure support assisted by manual or automated ventilation may be appropriately reduced. For example, the better the patient is able to breathe, the less pressure support may be required by positive pressure ventilation as set forth in [0299]).
Claim 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Campana (US 20170266399 A1), in view of Acker (US 20150273176 A1) and Gallagher (US 5529093 A) as applied to claim 1, in view of Costella (US 20180161531 A1).
Regarding claim 8, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Campana as modified fails to explicitly disclose, wherein the device comprises at least one absolute pressure sensor configured to sense a pressure outside of the conduit.
However, Costella teaches, wherein the device comprises at least one absolute pressure sensor configured to sense a pressure outside of the conduit (Costella: FIG. 34 A second pressure sensor 124 may be included to measure atmospheric pressure and results in a more robust design that is capable of accurate internal pressure measurement, independent of the external environment as set forth in [0202]).
Campana and Costella are both considered to be analogous to the claimed invention because they are in the same field of tubular conduits delivering gas to a patient and sensing means thereof. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensing device of Campana to incorporate the teaching of Costella and include, wherein the device comprises at least one absolute pressure sensor configured to sense a pressure outside of the conduit (Costella: FIG. 34 A second pressure sensor 124 may be included to measure atmospheric pressure and results in a more robust design that is capable of accurate internal pressure measurement, independent of the external environment as set forth in [0202]). Doing so would result in a more robust design that is capable of accurate internal pressure measurement, independent of the external environment (Costella: As set forth in [0202]).
Regarding claim 11, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Campana as modified fails to explicitly disclose, wherein the device comprises at least one absolute pressure sensor configured to sense a pressure outside of the conduit, and wherein the at least one absolute pressure sensor is configured for use in calibration of the measurement of the flow of the gas inside of the conduit.
However, Costella teaches, wherein the device comprises at least one absolute pressure sensor configured to sense a pressure outside of the conduit, and wherein the at least one absolute pressure sensor is configured for use in calibration of the measurement of the flow of the gas inside of the conduit (Costella: FIG. 34 A second pressure sensor 124 may be included to measure atmospheric pressure and results in a more robust design that is capable of accurate internal pressure measurement, independent of the external environment as set forth in [0202]).
Campana and Costella are both considered to be analogous to the claimed invention because they are in the same field of tubular conduits delivering gas to a patient and sensing means thereof. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensing device of Campana to incorporate the teaching of Costella and include, wherein the device comprises at least one absolute pressure sensor configured to sense a pressure outside of the conduit, and wherein the at least one absolute pressure sensor is configured for use in calibration of the measurement of the flow of the gas inside of the conduit (Costella: FIG. 34 A second pressure sensor 124 may be included to measure atmospheric pressure and results in a more robust design that is capable of accurate internal pressure measurement, independent of the external environment as set forth in [0202]). Doing so would result in a more robust design that is capable of accurate internal pressure measurement, independent of the external environment (Costella: As set forth in [0202]).
Campana as modified by Costella fails to explicitly disclose wherein the calibration is based on detection of an ambient pressure that is lower than a sea level ambient pressure, wherein the ambient pressure is at an altitude higher than sea level.
However, given that in Costella, the sensor configuration is allowing for accurate internal pressure measurement, independent of the external environment (Costella: As set forth in [0202]) for each pressure measurement taken, it would indicate that if the device was is an environment where the ambient pressure is lower than a sea level ambient pressure, wherein the wherein the ambient pressure is at an altitude higher than sea level, the pressure sensor configured to sense a pressure outside of the conduit (Costella: FIG. 34 A second pressure sensor 124 may be included to measure atmospheric pressure and results in a more robust design that is capable of accurate internal pressure measurement, independent of the external environment as set forth in [0202]) would measure the “low” ambient pressure, and the calibration would take place.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Campana (US 20170266399 A1), in view of Acker (US 20150273176 A1) and Gallagher (US 5529093 A) as applied to claim 1, in view of Mesmer (US 20220305300 A1), in further view of Openstax (OpenStax. (2016). 11.6 Gauge Pressure, Absolute Pressure, and Pressure Measurement. Pressbooks.bccampus.ca. https://pressbooks.bccampus.ca/collegephysics/chapter/gauge-pressure-absolute-pressure-and-pressure-measurement/; Accessed 6/11/2026)
Regarding claim 12, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Campana as modified fails to explicitly disclose, wherein the at least one pressure sensor comprises: a differential pressure sensor, disposed at least in part inside of the conduit, configured to sense a pressure difference between a pressure inside of the conduit and a pressure outside of the conduit; and an absolute pressure sensor configured to sense the pressure outside of the conduit.
However, Mesmer teaches, wherein the at least one pressure sensor comprises: a differential pressure sensor, disposed at least in part inside of the system, configured to sense a pressure difference between a pressure inside of the system and a pressure outside of the system (FIG. 1 A second differential pressure sensor 550 as set forth in [0039], generates a second differential pressure signal 552, which corresponds to the differential pressure between mask 600 and the ambient gas 250 as set forth in [0043]); and an absolute pressure sensor configured to sense the pressure outside of the system conduit (FIG. 1 the controller 800 receives an absolute pressure signal 502 from the absolute pressure signal 500. The absolute pressure signal 502 corresponds to the absolute pressure of the ambient gas 250 of the environment as set forth in [0042]).
Campana and Mesmer are both considered to be analogous to the claimed invention because they are in the same field of delivering breathing gas to a patient and the sensing means thereof. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the conduit of the sensing device of Campana to incorporate the teaching of Mesmer and include, wherein at least one pressure sensor comprises: a differential pressure sensor, disposed at least in part inside of the system, configured to sense a pressure difference between a pressure inside of the system and a pressure outside of the system (FIG. 1 A second differential pressure sensor 550 as set forth in [0039], generates a second differential pressure signal 552, which corresponds to the differential pressure between mask 600 and the ambient gas 250 as set forth in [0043]); and an absolute pressure sensor configured to sense the pressure outside of the system (FIG. 1 the controller 800 receives an absolute pressure signal 502 from the absolute pressure signal 500. The absolute pressure signal 502 corresponds to the absolute pressure of the ambient gas 250 of the environment as set forth in [0042]). In the case of Campana as modified, the system being the conduit of the sensing device. Doing so would provide an absolute pressure of the environment for use as a reference to determine the properties of the source gas and the ambient gas, as well as to determine the altitude of the breathing regulator (Mesmer: As set forth in [0042]) as well as use the differential pressure signal for use in generating control signals, including that of one which allows for the pressure within the system to meet a desired differential pressure signal (Mesmer: As set forth in [0055]).
Campana as modified by Mesmer fails to explicitly disclose, wherein the differential pressure sensor and the absolute pressure sensor are configured for use in determination of the pressure inside of the conduit.
However, Openstax teaches, wherein determination of the pressure inside of the system can be calculated using a differential pressure and an absolute pressure of the environment, specifically, wherein the total pressure within a system is the sum of gauge pressure, or the differential pressure, and the atmospheric pressure, due to Pascal’s principle (Openstax: As set forth on page 3). The calculation of the pressure inside the system accounting for the effect of the atmospheric pressure (Openstax: As set on pages 2-3).
Campana and Openstax are both considered to be analogous to the claimed invention because they are in the same field of measuring the pressure of a fluid. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressure sensor configuration of the sensing device of Campana to incorporate the teaching of Mesmer and include, wherein determination of the pressure inside of the system can be calculated using a differential pressure and an absolute pressure of the environment, specifically, wherein the total pressure within a system is the sum of gauge pressure, or the differential pressure, and the atmospheric pressure, due to Pascal’s principle (Openstax: As set forth on page 3). Doing so would provide a method of determining the pressure inside the system, and ensure that the calculation of the pressure inside the system is accounting for the effects of the atmospheric pressure on the total pressure inside the system (Openstax: As set forth on pages 2-3), in the case of Capana as modified, inside the conduit of the sensing device.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Campana (US 20170266399 A1), in view of Acker (US 20150273176 A1) and Gallagher (US 5529093 A) as applied to claim 1, in view of Colman (US 20180206737 A1).
Regarding claim 24, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Campana as modified is silent as to the composition of the thermal mass flow sensor and fail to explicitly disclose, wherein the thermal mass flow sensor comprises a hot wire anemometer.
However, Colman teaches wherein the thermal mass flow sensor comprises a hot wire anemometer (Colman: As set forth in [0048]).
Campana and Colman are both considered to be analogous to the claimed invention because they are in the same field of sensors measuring a gas to determine the status of a patient. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensing device of Campana to incorporate the teaching of Colman and include, wherein the thermal mass flow sensor comprises a hot wire anemometer (Colman: As set forth in [0048]). Doing so provides a known aspect of thermal mass flow sensor in the art of the claimed invention for measuring flow (Colman: As set forth in [0048]).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Campana (US 20170266399 A1), in view of Acker (US 20150273176 A1) and Gallagher (US 5529093 A) as applied to claim 1, in view of Dellimore (US 20220313933 A1).
Regarding claim 36, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Campana as modified fails to explicitly disclose, wherein the measurement of the pressure inside of the conduit reflects a smaller delay, relative to a current patient airway pressure, than measurement of patient airway pressure using one or more sensors that are located at a distance from the patient's airway that is greater than a distance from the sensing device to the patient's airway, wherein the smaller delay causes a smaller risk of occurrence of patient ventilator asynchrony.
However, Dellimore teaches, wherein delay in the measurement of patient airway parameter made for controlling the operation of a ventilator can cause a risk of patient ventilator asynchrony (Dellimore: Asynchronies occur when patients are “fighting with the ventilator”, as a result of a mismatch between the patient's respiratory efforts and the ventilator-delivered breaths. Several different types of asynchronies can arise, e.g., due to ineffective triggering, auto-triggering, trigger delay, expiratory muscle contraction, etc as set forth in [0144]).
Campana and Dellimore are both considered to be analogous to the claimed invention because they are in the same field of delivering breathing gas to a user, wherein the flow and pressure of the gas are monitored and controlled. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensing device of Campana to incorporate the teaching of Dellimore and include, wherein delay in the measurement of patient airway parameter made for controlling the operation of a ventilator can cause a risk of patient ventilator asynchrony (Dellimore: Asynchronies occur when patients are “fighting with the ventilator”, as a result of a mismatch between the patient's respiratory efforts and the ventilator-delivered breaths. Several different types of asynchronies can arise, e.g., due to ineffective triggering, auto-triggering, trigger delay, expiratory muscle contraction, etc as set forth in [0144]). Doing so provides known causes for the occurrence of asynchronies between the patient and ventilator based on the trigger delay present in control of the operation of the ventilator (Dellimore: As set forth in [0144]).
Additionally, it would be obvious to one of ordinary skill in the art that a pressure sensor located at a closer distance from the patient’s airway would have a smaller delay in triggering the ventilator than one further from the patient airway, because the patient’s airway pressure is being measured earlier in the circuit which would reduce the time between when the patient’s airway is generating a pressure change and the detection of that change by the sensor which in turn produces a signal for communication with a processor/controller of the medical device. Given the difference in delay caused by the location of the pressure sensor within the breathing circuit, it would be the case that in the sensing device of Campana as modified, the measurement of the pressure inside of the conduit would reflect a smaller delay, relative to a current patient airway pressure, than measurement of patient airway pressure using one or more sensors that are located at a distance from the patient's airway that is greater than a distance from the sensing device to the patient's airway, wherein the smaller delay would cause a smaller risk of occurrence of patient ventilator asynchrony.
Claims 50, 59, 70, 74, 77-79, 82-84, 95, 104-105, and 108 are rejected under 35 U.S.C. 103 as being unpatentable over Campana (US 20170266399 A1), in view of Acker (US 20150273176 A1).
Regarding claim 50, Campana discloses a system for use in ventilation treatment (FIGS. 6-18 a flow sensor system 100 as set forth in [0170]), comprising: a gas flow conduit configured to be coupled with a patient airway (The flow sensor system system comprises a flow conduit configured to be placed in a patient airway and having a lumen that accommodates gas flow as set forth in [0008], FIG. 9(a) Lumen 102 of the flow conduit 101 as set forth in [0174]); a means for measuring a flow of gas inside the conduit (FIG. 7 A flow restrictor 105 is disposed within the lumen 102 of the flow conduit 101 between the first region 103 and the second region 104 so as to extend across all or a portion of the lumen 102 in order to obstruct the flow of gas through the lumen between the first region 103 and the second region 104 and create a pressure drop in the flow, which can be measured to calculate a flow rate and/or volume of the gas passing through the flow conduit 101 as set forth in [0171]); at least one pressure sensor configured for measurement of a pressure inside of the conduit (FIG. 9(a) First absolute pressure sensor 131 disposed adjacent to the first region 103 as set forth in [0176]), wherein the pressure inside of the conduit reflects a patient airway pressure (The flow sensor system comprises a flow conduit configured to be placed in a patient airway and having a lumen that accommodates gas flow as set forth in [0008], indicating the pressure inside the conduit reflects a patient airway pressure); and at least one processor configured to: receive signals related to the flow within the conduit and the at least one pressure sensor; and using the received signals, determine a flow rate of the gas inside of the conduit and a pressure inside of the conduit (FIG. 41 depicts a series of graphs that show the absolute pressure, pressure differential and flow rate detected over time by the flow sensor system for a spontaneously breathing patient as set forth in [0295]; Additionally, the flow sensor system further comprises a processor, configured to send a signal displaying physiological data of the patient (e.g., vitals information) and resuscitative information to a user (e.g., feedback to adjust the gas flow through the lumen of the flow conduit, or other instructions, the physiological data may include at least one of ECG (Electrocardiography) data, SpO2 data, EtCO2 data, blood pressure, heart rate, temperature, SmO2 and muscle pH of the patient, or other physiological information as set forth in [0012]; the device having one or more additional sensors that may be used to sense the relative concentration of gas flowing through the conduit, e.g., oxygen, carbon dioxide concentration, as set forth in [0217]).
Campana fails to explicitly disclose, wherein a thermal mass flow sensor is disposed at least in part inside of the conduit, configured for measurement of a flow of gas inside of the conduit.
However, Acker teaches, wherein a thermal mass flow sensor is disposed at least in part inside of the conduit, configured for measurement of a flow of gas inside of the conduit (Acker: FIG. 4A-B bi-directional BCG flow sensor 402 can be a thermal mass flow meter capable of measuring flow in both the forward and reverse direction without substantially interfering with flow and/or pressure in the patient breathing circuit as set forth in [0079]-[0080]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Campana, including the sensor configuration and their communication the processor, to incorporate the teaching of Acker and include, wherein a thermal mass flow sensor is disposed at least in part inside of the conduit, configured for measurement of a flow of gas inside of the conduit (Acker: FIG. 4A-B bi-directional BCG flow sensor 402 can be a thermal mass flow meter capable of measuring flow in both the forward and reverse direction without substantially interfering with flow and/or pressure in the patient breathing circuit as set forth in [0079]-[0080]). Doing so would provide a means for measuring flow in both the forward and reverse direction without substantially interfering with flow and/or pressure in the patient breathing circuit (e.g., as flow and/or pressure in the breathing circuit can be extremely precise and important for treating the patient) that provides a substantially fast response time (Acker: As set forth in [0080]).
Regarding claim 59, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 50 above.
Campana as modified further discloses, wherein the at least one processor is configured to use sensed flow rate data relating to the flow of the gas inside of the conduit and sensed pressure data relating to the pressure inside of the conduit in determining ventilation feedback and chest compression feedback (FIG. 44 provides a flow chart illustrating an embodiment of the process through which a system may utilize information provided from the flow sensor. As shown, the system may detect whether flow is occurring through the conduit based on whether a threshold flow rate or volume has been met. If flow has been detected, then a user interface or display provided by a device of the system or monitor thereof, may enter into a mode that accounts for ventilation parameters. For example, in response to flow detection, the device may produce a ventilation dashboard displayed on a screen thereof. In some embodiments, an overall CPR dashboard may be displayed, which has a chest compression dashboard portion and a ventilation dashboard portion, as appropriate for the type of treatment(s) to be provided, when manual ventilations are detected, the system may sense when the patient is just beginning a spontaneous inspiratory breath, and immediately prompt the rescuer to administer a manual ventilation so that the positive pressure breath is provided as air is being pulled into the lungs; ventilation prompts may be provided according to a timed rate such as in the case of a continuous breath protocol, or ventilation prompts may be provided according to the number of chest compressions that have been administered; for example, the system may countdown the number of chest compression that have occurred and prompt the rescuer to vent when the countdown has finished as set forth in [0302]-[0305]).
Regarding claim 70, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 50 above.
Campana as modified by Acker further teaches the device, comprising a carbon dioxide sensor for sensing carbon dioxide in the gas inside of the conduit, wherein the conduit, the thermal mass flow sensor (As modified above for claim 50 by Acker), the at least one pressure sensor and the carbon dioxide sensor are fixed relative to each other (one or more additional sensors may be used to sense the relative concentration of gas flowing through the conduit (e.g., oxygen, carbon dioxide concentration as set forth in [0217]; the conduit, the thermal mass flow sensor, the at least one pressure sensor and the carbon dioxide sensor are fixed relative to each other in respect to the way that the sensors are all measuring the gas directly from the conduit and are therefore relative to each other).
Regarding claim 74, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 50 above.
Campana as modified further discloses, the device, comprising a connection adapter configured for facilitating electrical connection of the device to a medical device, wherein the connection adapter is rotatable relative to the conduit (FIG. 6-9 and 16-18 The protuberances 147 on the snap arms 109 engage within the indentation 140 on the housing 138 to maintain the engagement between the connector 113 and the snap arms 109 while allowing the connector 113 to rotate with respect to the flow conduit 101 without becoming disengaged and allowing the connector 113 to be coupled to the flow conduit 101 from a variety of angular orientations as set forth in [0231], [0233], and [0236]; the connector 113 for establishing communication between any suitable medical devices as set forth in [0269]).
Regarding claim 77, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 50 above.
Campana as modified further discloses, wherein the at least one processor is configured to, based at least in part on the determined flow rate of the gas inside of the conduit, detect a leak in the conduit (The system may further be able to detect the presence of a leak. For example, if there is no leak, the inspiratory and expiratory volumes will be substantially the same. Conversely, if a leak exists, the inspiratory and expiratory volumes will noticeably differ. In certain embodiments, if the difference in magnitude between inspiratory flow volume and expiratory flow volume is high enough to meet a predetermined threshold, then the system may indicate that a possible leak exists. When it is determined that a leak is present, the system may produce a signal to alert the user, for example, to check that the ventilation connection(s) are appropriately sealed as set forth in [0224]).
Regarding claim 78, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 50 above.
Campana as modified further discloses, wherein the at least one processor is configured to: based at least in part on the determined pressure inside of the conduit, determine a patient airway pressure waveform reflecting the patient airway pressure over time; and based at least in part on one or more morphological features of the patient airway pressure waveform, determine at least one current condition of the patient waveform (FIG. 41 Such a flow profile may also be indicative of a patient who is experiencing agonal respiration, which is generally characterized by an abnormal pattern of breathing and may include gasping, labored breathing, accompanied by irregular vocalization and/or myoclonus. In a spontaneous breath, because air is drawn in due to negative pressure generated by downward movement of the diaphragm, the absolute pressure senses an initial decrease during inspiration, followed by an increase in pressure during expiration as set forth in [0259]; when the system detects an initial negative pressure change and a threshold level of flow rate or volume, the system may provide an indication to the rescuer or other device that the patient may be undergoing spontaneous breathing. This information, while not conclusive, may be further useful in providing a rescuer with an indication that the patient may be experiencing return of spontaneous circulation (ROSC). For example, the system may provide a display to the rescuer of “Possible ROSC” and/or may provide appropriate instructions/guidance as set forth in [0296]; The pressure waveform is further characterized by a plateau at the height of the ventilator breath, which is distinct from a positive pressure breath given by manual ventilation as set forth in [0297]; By determining the type of breath that is occurring, rescuers can be alerted whether the patient has begun spontaneous breathing and adjust the treatment protocol accordingly. For instance, for a spontaneously breathing patient, the rescuer may adjust how much additional ventilator support is necessary to give above what the patient is generating on their own. That is, when the patient is spontaneously breathing, the amount of pressure support assisted by manual or automated ventilation may be appropriately reduced. For example, the better the patient is able to breathe, the less pressure support may be required by positive pressure ventilation as set forth in [0299]).
Regarding claim 79, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 78 above.
Campana as modified further discloses, wherein the at least one current condition of the patient comprises at least one of: spontaneous breathing, ROSC and agonal breathing (FIG. 41 Such a flow profile may also be indicative of a patient who is experiencing agonal respiration, which is generally characterized by an abnormal pattern of breathing and may include gasping, labored breathing, accompanied by irregular vocalization and/or myoclonus. In a spontaneous breath, because air is drawn in due to negative pressure generated by downward movement of the diaphragm, the absolute pressure senses an initial decrease during inspiration, followed by an increase in pressure during expiration as set forth in [0259]; when the system detects an initial negative pressure change and a threshold level of flow rate or volume, the system may provide an indication to the rescuer or other device that the patient may be undergoing spontaneous breathing. This information, while not conclusive, may be further useful in providing a rescuer with an indication that the patient may be experiencing return of spontaneous circulation (ROSC). For example, the system may provide a display to the rescuer of “Possible ROSC” and/or may provide appropriate instructions/guidance as set forth in [0296]; By determining the type of breath that is occurring, rescuers can be alerted whether the patient has begun spontaneous breathing and adjust the treatment protocol accordingly. For instance, for a spontaneously breathing patient, the rescuer may adjust how much additional ventilator support is necessary to give above what the patient is generating on their own. That is, when the patient is spontaneously breathing, the amount of pressure support assisted by manual or automated ventilation may be appropriately reduced. For example, the better the patient is able to breathe, the less pressure support may be required by positive pressure ventilation as set forth in [0299]).
Regarding claim 82, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 78 above.
Campana as modified further discloses, wherein the one or more morphological features comprise at least a plateau (FIG. 41-42 The pressure waveform is further characterized by a plateau at the height of the ventilator breath, which is distinct from a positive pressure breath given by manual ventilation as set forth in [0297]; By determining the type of breath that is occurring, rescuers can be alerted whether the patient has begun spontaneous breathing and adjust the treatment protocol accordingly. For instance, for a spontaneously breathing patient, the rescuer may adjust how much additional ventilator support is necessary to give above what the patient is generating on their own. That is, when the patient is spontaneously breathing, the amount of pressure support assisted by manual or automated ventilation may be appropriately reduced. For example, the better the patient is able to breathe, the less pressure support may be required by positive pressure ventilation as set forth in [0299]).
Regarding claim 83, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 78 above.
Campana as modified further discloses, wherein the at least one processor is configured to: based at least in part on the determined flow of gas inside of the conduit, determine a flow waveform reflecting the flow over time; and based at least in part on one or more morphological features of the flow waveform, determine the at least one current condition of the patient (FIG. 41 Such a flow profile may also be indicative of a patient who is experiencing agonal respiration, which is generally characterized by an abnormal pattern of breathing and may include gasping, labored breathing, accompanied by irregular vocalization and/or myoclonus. In a spontaneous breath, because air is drawn in due to negative pressure generated by downward movement of the diaphragm, the absolute pressure senses an initial decrease during inspiration, followed by an increase in pressure during expiration as set forth in [0259]; when the system detects an initial negative pressure change and a threshold level of flow rate or volume, the system may provide an indication to the rescuer or other device that the patient may be undergoing spontaneous breathing. This information, while not conclusive, may be further useful in providing a rescuer with an indication that the patient may be experiencing return of spontaneous circulation (ROSC). For example, the system may provide a display to the rescuer of “Possible ROSC” and/or may provide appropriate instructions/guidance as set forth in [0296]).
Regarding claim 84, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 50 above.
Campana as modified further discloses, wherein the at least one processor is configured to: based at least in part on the determined pressure inside of the conduit, determine a patient airway pressure waveform reflecting patient airway pressure over time; and based at least in part on one or more morphological features of the waveform, determine at least one current condition relating to treatment (FIG. 41 Such a flow profile may also be indicative of a patient who is experiencing agonal respiration, which is generally characterized by an abnormal pattern of breathing and may include gasping, labored breathing, accompanied by irregular vocalization and/or myoclonus. In a spontaneous breath, because air is drawn in due to negative pressure generated by downward movement of the diaphragm, the absolute pressure senses an initial decrease during inspiration, followed by an increase in pressure during expiration as set forth in [0259]; when the system detects an initial negative pressure change and a threshold level of flow rate or volume, the system may provide an indication to the rescuer or other device that the patient may be undergoing spontaneous breathing. This information, while not conclusive, may be further useful in providing a rescuer with an indication that the patient may be experiencing return of spontaneous circulation (ROSC). For example, the system may provide a display to the rescuer of “Possible ROSC” and/or may provide appropriate instructions/guidance as set forth in [0296]; The pressure waveform is further characterized by a plateau at the height of the ventilator breath, which is distinct from a positive pressure breath given by manual ventilation as set forth in [0297]; By determining the type of breath that is occurring, rescuers can be alerted whether the patient has begun spontaneous breathing and adjust the treatment protocol accordingly. For instance, for a spontaneously breathing patient, the rescuer may adjust how much additional ventilator support is necessary to give above what the patient is generating on their own. That is, when the patient is spontaneously breathing, the amount of pressure support assisted by manual or automated ventilation may be appropriately reduced. For example, the better the patient is able to breathe, the less pressure support may be required by positive pressure ventilation as set forth in [0299]).
Regarding claim 95, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 50 above.
Campana as modified further discloses, wherein the system is configured to output signaling for use in: determining at least one waveform associated with a value of at least one ventilatory parameter over time; and based at least in part on one or more morphological features of the at least one waveform, determine at least one current condition of the patient or at least one current condition relating to treatment of the patient (FIG. 41 Such a flow profile may also be indicative of a patient who is experiencing agonal respiration, which is generally characterized by an abnormal pattern of breathing and may include gasping, labored breathing, accompanied by irregular vocalization and/or myoclonus. In a spontaneous breath, because air is drawn in due to negative pressure generated by downward movement of the diaphragm, the absolute pressure senses an initial decrease during inspiration, followed by an increase in pressure during expiration as set forth in [0259]; when the system detects an initial negative pressure change and a threshold level of flow rate or volume, the system may provide an indication to the rescuer or other device that the patient may be undergoing spontaneous breathing. This information, while not conclusive, may be further useful in providing a rescuer with an indication that the patient may be experiencing return of spontaneous circulation (ROSC). For example, the system may provide a display to the rescuer of “Possible ROSC” and/or may provide appropriate instructions/guidance as set forth in [0296]; The pressure waveform is further characterized by a plateau at the height of the ventilator breath, which is distinct from a positive pressure breath given by manual ventilation as set forth in [0297]; By determining the type of breath that is occurring, rescuers can be alerted whether the patient has begun spontaneous breathing and adjust the treatment protocol accordingly. For instance, for a spontaneously breathing patient, the rescuer may adjust how much additional ventilator support is necessary to give above what the patient is generating on their own. That is, when the patient is spontaneously breathing, the amount of pressure support assisted by manual or automated ventilation may be appropriately reduced. For example, the better the patient is able to breathe, the less pressure support may be required by positive pressure ventilation as set forth in [0299]).
Regarding claim 104, Campana discloses, a method for providing feedback to a care provider in providing treatment to a patient (The system may provide a display to the rescuer of “Possible ROSC” and/or may provide appropriate instructions/guidance as set forth in [0296]; The pressure waveform is further characterized by a plateau at the height of the ventilator breath, which is distinct from a positive pressure breath given by manual ventilation as set forth in [0297]; By determining the type of breath that is occurring, rescuers can be alerted whether the patient has begun spontaneous breathing and adjust the treatment protocol accordingly. For instance, for a spontaneously breathing patient, the rescuer may adjust how much additional ventilator support is necessary to give above what the patient is generating on their own. That is, when the patient is spontaneously breathing, the amount of pressure support assisted by manual or automated ventilation may be appropriately reduced. For example, the better the patient is able to breathe, the less pressure support may be required by positive pressure ventilation as set forth in [0299]), the method comprising: using a means for measuring a flow of gas disposed within a gas flow conduit of a sensing device used in providing ventilation treatment to the patient (FIG. 7 A flow restrictor 105 is disposed within the lumen 102 of the flow conduit 101 between the first region 103 and the second region 104 so as to extend across all or a portion of the lumen 102 in order to obstruct the flow of gas through the lumen between the first region 103 and the second region 104 and create a pressure drop in the flow, which can be measured to calculate a flow rate and/or volume of the gas passing through the flow conduit 101 as set forth in [0171]), the conduit being coupled with an airway of the patient, determining a flow rate of gas inside of the conduit (The flow sensor system comprises a flow conduit configured to be placed in a patient airway and having a lumen that accommodates gas flow as set forth in [0008], FIG. 9(a) Lumen 102 of the flow conduit 101 as set forth in [0174]); using at least one pressure sensor disposed at least in part in the conduit, determining a pressure inside of the conduit , wherein the pressure inside of the conduit reflects a patient airway pressure (FIG. 9(a) First absolute pressure sensor 131 disposed adjacent to the first region 103 as set forth in [0176]); based at least in part on the determined flow rate of the gas inside of the conduit and the determined pressure inside of the conduit (FIG. 41 depicts a series of graphs that show the absolute pressure, pressure differential and flow rate detected over time by the flow sensor system for a spontaneously breathing patient as set forth in [0295]; Additionally, the flow sensor system further comprises a processor, configured to send a signal displaying physiological data of the patient (e.g., vitals information) and resuscitative information to a user (e.g., feedback to adjust the gas flow through the lumen of the flow conduit, or other instructions, the physiological data may include at least one of ECG (Electrocardiography) data, SpO2 data, EtCO2 data, blood pressure, heart rate, temperature, SmO2 and muscle pH of the patient, or other physiological information as set forth in [0012]; the device having one or more additional sensors that may be used to sense the relative concentration of gas flowing through the conduit, e.g., oxygen, carbon dioxide concentration, as set forth in [0217]; For example, FIGS. 49(a) and 49(b) show the expired CO2 tension versus exhaled volume, wherein including dynamic lung compliance in the calculation of overall lung volume using SBCO2 curves may enhance the accuracy produced by SBCO2-based calculations as set forth in [0317]), determining the feedback, comprising at least one of ventilation treatment feedback and chest compression feedback, to be provided to the care provider during the treatment of the patient; and presenting the feedback to the care provider during the treatment of the patient (FIG. 41 Such a flow profile may also be indicative of a patient who is experiencing agonal respiration, which is generally characterized by an abnormal pattern of breathing and may include gasping, labored breathing, accompanied by irregular vocalization and/or myoclonus. In a spontaneous breath, because air is drawn in due to negative pressure generated by downward movement of the diaphragm, the absolute pressure senses an initial decrease during inspiration, followed by an increase in pressure during expiration as set forth in [0259]; when the system detects an initial negative pressure change and a threshold level of flow rate or volume, the system may provide an indication to the rescuer or other device that the patient may be undergoing spontaneous breathing. This information, while not conclusive, may be further useful in providing a rescuer with an indication that the patient may be experiencing return of spontaneous circulation (ROSC). For example, the system may provide a display to the rescuer of “Possible ROSC” and/or may provide appropriate instructions/guidance as set forth in [0296]; By determining the type of breath that is occurring, rescuers can be alerted whether the patient has begun spontaneous breathing and adjust the treatment protocol accordingly. For instance, for a spontaneously breathing patient, the rescuer may adjust how much additional ventilator support is necessary to give above what the patient is generating on their own. That is, when the patient is spontaneously breathing, the amount of pressure support assisted by manual or automated ventilation may be appropriately reduced. For example, the better the patient is able to breathe, the less pressure support may be required by positive pressure ventilation as set forth in [0299]; Additionally, the EtCO2 measurements can be used to confirm placement of the endotracheal tube as set forth in [0226] and [0229] or provide recommendations to titrate ventilation rate to achieve a particular end tidal CO2 value as set forth in [0307], and based on the SBCO2 curve, calculations can be made to determine both alveolar as well as non-alveolar deadspace based on techniques known to those skilled in the art, the sum of these two deadspaces does not produce any gas exchange in the patient, so this sets the minimum ventilation volume for each patient as set forth in [0315]-[0317], the minimum ventilation being used as further shown in FIG. 45(b), when the dashboard prompts the user to ventilate, the volume indication (numerical value and bar graph) resets and provides the ventilation volume when the breath is applied. FIG. 45(c) shows the ventilation volume to be 800 mL, which falls outside of the specified range. Accordingly, the dashboard provides an indication to the user that the patient has been overventilated. This may provide a signal to the user to lessen the ventilation volume of the next positive pressure breath as set forth in [0308]; the minimum ventilation calculated via the waveforms being current condition of the patient or at least one current condition relating to treatment of the patient).
Campana fails to explicitly disclose, wherein a thermal mass flow sensor is disposed at least in part inside of the conduit, configured for measurement of a flow of gas inside of the conduit.
However, Acker teaches, wherein a thermal mass flow sensor is disposed at least in part inside of the conduit, configured for measurement of a flow of gas inside of the conduit (Acker: FIG. 4A-B bi-directional BCG flow sensor 402 can be a thermal mass flow meter capable of measuring flow in both the forward and reverse direction without substantially interfering with flow and/or pressure in the patient breathing circuit as set forth in [0079]-[0080]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Campana, including the sensor configuration and their communication the processor, to incorporate the teaching of Acker and include, wherein a thermal mass flow sensor is disposed at least in part inside of the conduit, configured for measurement of a flow of gas inside of the conduit (Acker: FIG. 4A-B bi-directional BCG flow sensor 402 can be a thermal mass flow meter capable of measuring flow in both the forward and reverse direction without substantially interfering with flow and/or pressure in the patient breathing circuit as set forth in [0079]-[0080]). Doing so would provide a means for measuring flow in both the forward and reverse direction without substantially interfering with flow and/or pressure in the patient breathing circuit (e.g., as flow and/or pressure in the breathing circuit can be extremely precise and important for treating the patient) that provides a substantially fast response time (Acker: As set forth in [0080]).
Regarding claim 105, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 104 above.
Campana as modified further discloses, wherein the treatment comprises the ventilation treatment, and wherein the feedback comprises ventilation treatment feedback (FIG. 9(a) First absolute pressure sensor 131 disposed adjacent to the first region 103 as set forth in [0176]); based at least in part on the determined flow rate of the gas inside of the conduit and the determined pressure inside of the conduit (FIG. 41 depicts a series of graphs that show the absolute pressure, pressure differential and flow rate detected over time by the flow sensor system for a spontaneously breathing patient as set forth in [0295]; Additionally, the flow sensor system further comprises a processor, configured to send a signal displaying physiological data of the patient (e.g., vitals information) and resuscitative information to a user (e.g., feedback to adjust the gas flow through the lumen of the flow conduit, or other instructions, the physiological data may include at least one of ECG (Electrocardiography) data, SpO2 data, EtCO2 data, blood pressure, heart rate, temperature, SmO2 and muscle pH of the patient, or other physiological information as set forth in [0012]; the device having one or more additional sensors that may be used to sense the relative concentration of gas flowing through the conduit, e.g., oxygen, carbon dioxide concentration, as set forth in [0217]; For example, FIGS. 49(a) and 49(b) show the expired CO2 tension versus exhaled volume, wherein including dynamic lung compliance in the calculation of overall lung volume using SBCO2 curves may enhance the accuracy produced by SBCO2-based calculations as set forth in [0317]), determining the feedback, comprising at least one of ventilation treatment feedback and chest compression feedback, to be provided to the care provider during the treatment of the patient; and presenting the feedback to the care provider during the treatment of the patient (FIG. 41 Such a flow profile may also be indicative of a patient who is experiencing agonal respiration, which is generally characterized by an abnormal pattern of breathing and may include gasping, labored breathing, accompanied by irregular vocalization and/or myoclonus. In a spontaneous breath, because air is drawn in due to negative pressure generated by downward movement of the diaphragm, the absolute pressure senses an initial decrease during inspiration, followed by an increase in pressure during expiration as set forth in [0259]; when the system detects an initial negative pressure change and a threshold level of flow rate or volume, the system may provide an indication to the rescuer or other device that the patient may be undergoing spontaneous breathing. This information, while not conclusive, may be further useful in providing a rescuer with an indication that the patient may be experiencing return of spontaneous circulation (ROSC). For example, the system may provide a display to the rescuer of “Possible ROSC” and/or may provide appropriate instructions/guidance as set forth in [0296]; By determining the type of breath that is occurring, rescuers can be alerted whether the patient has begun spontaneous breathing and adjust the treatment protocol accordingly. For instance, for a spontaneously breathing patient, the rescuer may adjust how much additional ventilator support is necessary to give above what the patient is generating on their own. That is, when the patient is spontaneously breathing, the amount of pressure support assisted by manual or automated ventilation may be appropriately reduced. For example, the better the patient is able to breathe, the less pressure support may be required by positive pressure ventilation as set forth in [0299]; Additionally, the EtCO2 measurements can be used to confirm placement of the endotracheal tube as set forth in [0226] and [0229] or provide recommendations to titrate ventilation rate to achieve a particular end tidal CO2 value as set forth in [0307], and based on the SBCO2 curve, calculations can be made to determine both alveolar as well as non-alveolar deadspace based on techniques known to those skilled in the art, the sum of these two deadspaces does not produce any gas exchange in the patient, so this sets the minimum ventilation volume for each patient as set forth in [0315]-[0317], the minimum ventilation being used as further shown in FIG. 45(b), when the dashboard prompts the user to ventilate, the volume indication (numerical value and bar graph) resets and provides the ventilation volume when the breath is applied. FIG. 45(c) shows the ventilation volume to be 800 mL, which falls outside of the specified range. Accordingly, the dashboard provides an indication to the user that the patient has been overventilated. This may provide a signal to the user to lessen the ventilation volume of the next positive pressure breath as set forth in [0308]; the minimum ventilation calculated via the waveforms being current condition of the patient or at least one current condition relating to treatment of the patient).
Regarding claim 108, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 104 above.
Campana as modified further discloses, wherein the treatment comprises chest compressions, and wherein the feedback comprises chest compression feedback (FIG. 9(a) First absolute pressure sensor 131 disposed adjacent to the first region 103 as set forth in [0176]); based at least in part on the determined flow rate of the gas inside of the conduit and the determined pressure inside of the conduit (FIG. 41 depicts a series of graphs that show the absolute pressure, pressure differential and flow rate detected over time by the flow sensor system for a spontaneously breathing patient as set forth in [0295]; Additionally, the flow sensor system further comprises a processor, configured to send a signal displaying physiological data of the patient (e.g., vitals information) and resuscitative information to a user (e.g., feedback to adjust the gas flow through the lumen of the flow conduit, or other instructions, the physiological data may include at least one of ECG (Electrocardiography) data, SpO2 data, EtCO2 data, blood pressure, heart rate, temperature, SmO2 and muscle pH of the patient, or other physiological information as set forth in [0012]; the device having one or more additional sensors that may be used to sense the relative concentration of gas flowing through the conduit, e.g., oxygen, carbon dioxide concentration, as set forth in [0217]; For example, FIGS. 49(a) and 49(b) show the expired CO2 tension versus exhaled volume, wherein including dynamic lung compliance in the calculation of overall lung volume using SBCO2 curves may enhance the accuracy produced by SBCO2-based calculations as set forth in [0317]), determining the feedback, comprising at least one of ventilation treatment feedback and chest compression feedback, to be provided to the care provider during the treatment of the patient; and presenting the feedback to the care provider during the treatment of the patient (FIG. 41 Such a flow profile may also be indicative of a patient who is experiencing agonal respiration, which is generally characterized by an abnormal pattern of breathing and may include gasping, labored breathing, accompanied by irregular vocalization and/or myoclonus. In a spontaneous breath, because air is drawn in due to negative pressure generated by downward movement of the diaphragm, the absolute pressure senses an initial decrease during inspiration, followed by an increase in pressure during expiration as set forth in [0259]; when the system detects an initial negative pressure change and a threshold level of flow rate or volume, the system may provide an indication to the rescuer or other device that the patient may be undergoing spontaneous breathing. This information, while not conclusive, may be further useful in providing a rescuer with an indication that the patient may be experiencing return of spontaneous circulation (ROSC). For example, the system may provide a display to the rescuer of “Possible ROSC” and/or may provide appropriate instructions/guidance as set forth in [0296]; By determining the type of breath that is occurring, rescuers can be alerted whether the patient has begun spontaneous breathing and adjust the treatment protocol accordingly. For instance, for a spontaneously breathing patient, the rescuer may adjust how much additional ventilator support is necessary to give above what the patient is generating on their own. That is, when the patient is spontaneously breathing, the amount of pressure support assisted by manual or automated ventilation may be appropriately reduced. For example, the better the patient is able to breathe, the less pressure support may be required by positive pressure ventilation as set forth in [0299]; Additionally, the EtCO2 measurements can be used to confirm placement of the endotracheal tube as set forth in [0226] and [0229] or provide recommendations to titrate ventilation rate to achieve a particular end tidal CO2 value as set forth in [0307], and based on the SBCO2 curve, calculations can be made to determine both alveolar as well as non-alveolar deadspace based on techniques known to those skilled in the art, the sum of these two deadspaces does not produce any gas exchange in the patient, so this sets the minimum ventilation volume for each patient as set forth in [0315]-[0317], the minimum ventilation being used as further shown in FIG. 45(b), when the dashboard prompts the user to ventilate, the volume indication (numerical value and bar graph) resets and provides the ventilation volume when the breath is applied. FIG. 45(c) shows the ventilation volume to be 800 mL, which falls outside of the specified range. Accordingly, the dashboard provides an indication to the user that the patient has been overventilated. This may provide a signal to the user to lessen the ventilation volume of the next positive pressure breath as set forth in [0308]; the minimum ventilation calculated via the waveforms being current condition of the patient or at least one current condition relating to treatment of the patient).
Claims 53-54 are rejected under 35 U.S.C. 103 as being unpatentable over Campana (US 20170266399 A1), in view of Acker (US 20150273176 A1) as applied to claim 50, in view of Costella (US 20180161531 A1).
Regarding claim 53, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 50 above.
Campana as modified fails to explicitly disclose, wherein the system comprises at least one absolute pressure sensor, and wherein the at least one processor is further configured to, using signals received from the at least one absolute pressure sensor, determine a pressure outside of the conduit.
However, Costella teaches, wherein the system comprises at least one absolute pressure sensor, and wherein the at least one processor is further configured to, using signals received from the at least one absolute pressure sensor, determine a pressure outside of the conduit (Costella: FIG. 34 A second pressure sensor 124 may be included to measure atmospheric pressure and results in a more robust design that is capable of accurate internal pressure measurement, independent of the external environment as set forth in [0202]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensing device of Campana to incorporate the teaching of Costella and include, wherein the system comprises at least one absolute pressure sensor, and wherein the at least one processor is further configured to, using signals received from the at least one absolute pressure sensor, determine a pressure outside of the conduit (Costella: FIG. 34 A second pressure sensor 124 may be included to measure atmospheric pressure and results in a more robust design that is capable of accurate internal pressure measurement, independent of the external environment as set forth in [0202]). Doing so would result in a more robust design that is capable of accurate internal pressure measurement, independent of the external environment (Costella: As set forth in [0202]).
Regarding claim 54, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 53 above.
Campana as modified by Costella further teaches, wherein the at least one absolute pressure sensor is configured for use in calibration of the measurement of the flow of the gas inside of the conduit (Costella: FIG. 34 A second pressure sensor 124 may be included to measure atmospheric pressure and results in a more robust design that is capable of accurate internal pressure measurement, independent of the external environment as set forth in [0202]).
Campana as modified by Costella fails to explicitly disclose wherein the calibration is based on detection of an ambient pressure that is lower than a sea level ambient pressure, wherein the ambient pressure is at an altitude higher than sea level.
However, given that in Costella, the sensor configuration is allowing for accurate internal pressure measurement, independent of the external environment (Costella: As set forth in [0202]) for each pressure measurement taken, it would indicate that if the device was is an environment where the ambient pressure is lower than a sea level ambient pressure, wherein the wherein the ambient pressure is at an altitude higher than sea level, the pressure sensor configured to sense a pressure outside of the conduit (Costella: FIG. 34 A second pressure sensor 124 may be included to measure atmospheric pressure and results in a more robust design that is capable of accurate internal pressure measurement, independent of the external environment as set forth in [0202]) would measure the “low” ambient pressure, and the calibration would take place.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Campana (US 20170266399 A1), in view of Acker (US 20150273176 A1) as applied to claim 50, in view of Mesmer (US 20220305300 A1).
Regarding claim 55, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 50 above.
Campana as modified fails to explicitly disclose, wherein the at least one pressure sensor comprises: a differential pressure sensor, disposed at least in part inside of the conduit, configured to sense a pressure difference between a pressure inside of the conduit and a pressure outside of the conduit; and an absolute pressure sensor configured to sense the pressure outside of the conduit.
However, Mesmer teaches, wherein the at least one pressure sensor comprises: a differential pressure sensor, disposed at least in part inside of the system, configured to sense a pressure difference between a pressure inside of the system and a pressure outside of the system (FIG. 1 A second differential pressure sensor 550 as set forth in [0039], generates a second differential pressure signal 552, which corresponds to the differential pressure between mask 600 and the ambient gas 250 as set forth in [0043]); and an absolute pressure sensor configured to sense the pressure outside of the system conduit (FIG. 1 the controller 800 receives an absolute pressure signal 502 from the absolute pressure signal 500. The absolute pressure signal 502 corresponds to the absolute pressure of the ambient gas 250 of the environment as set forth in [0042]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the conduit of the sensing device of Campana to incorporate the teaching of Mesmer and include, wherein at least one pressure sensor comprises: a differential pressure sensor, disposed at least in part inside of the system, configured to sense a pressure difference between a pressure inside of the system and a pressure outside of the system (FIG. 1 A second differential pressure sensor 550 as set forth in [0039], generates a second differential pressure signal 552, which corresponds to the differential pressure between mask 600 and the ambient gas 250 as set forth in [0043]); and an absolute pressure sensor configured to sense the pressure outside of the system (FIG. 1 the controller 800 receives an absolute pressure signal 502 from the absolute pressure signal 500. The absolute pressure signal 502 corresponds to the absolute pressure of the ambient gas 250 of the environment as set forth in [0042]). In the case of Campana as modified, the system being the conduit of the sensing device. Doing so would provide an absolute pressure of the environment for use as a reference to determine the properties of the source gas and the ambient gas, as well as to determine the altitude of the breathing regulator (Mesmer: As set forth in [0042]) as well as use the differential pressure signal for use in generating control signals, including that of one which allows for the pressure within the system to meet a desired differential pressure signal (Mesmer: As set forth in [0055]).
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Campana (US 20170266399 A1), in view of Acker (US 20150273176 A1) as applied to claim 50, in view of Colman (US 20180206737 A1).
Regarding claim 67, Campana as modified discloses the claimed invention substantially as claimed as set forth for claim 50 above.
Campana as modified is silent as to the composition of the thermal mass flow sensor and fail to explicitly disclose, wherein the thermal mass flow sensor comprises a hot wire anemometer.
However, Colman teaches wherein the thermal mass flow sensor comprises a hot wire anemometer (Colman: As set forth in [0048]).
Campana and Colman are both considered to be analogous to the claimed invention because they are in the same field of sensors measuring a gas to determine the status of a patient. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensing device of Campana to incorporate the teaching of Colman and include, wherein the thermal mass flow sensor comprises a hot wire anemometer (Colman: As set forth in [0048]). Doing so provides a known aspect of thermal mass flow sensor in the art of the claimed invention for measuring flow (Colman: As set forth in [0048]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEIRA EILEEN CALLISON whose telephone number is (571)272-0745. The examiner can normally be reached Monday-Friday 7:30-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KEIRA EILEEN CALLISON/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights