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 1 and 17 are objected to because of the following informalities:
Claim 1 line 6 : “a person” should read “the person”
Claim 17 line 8 : “a person” should read “the person”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4, 7-12, 14-15, 17-21, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holder et al. 2014/0350427
Regarding claim 1, Holder teaches a sensor-based system for monitoring a person's breathing to automatedly detect a respiratory distress state, and for automatedly adjusting oxygen delivery to the person to mitigate the respiratory distress state (The abstract states “An method and system for supplemental gas delivery that enables the identification of a need of therapeutic attention for patient receiving the supplemental gas (20) by detecting an onset of an exacerbation of a medical condition. Such a detection is performed by detecting audible events using a microphone (60) that is in fluid communication with a cannula (28) that is used to communicate the supplemental gas (20) with the airways of the patient (8).” 0032 discusses the control of oxygen supply.), the system comprising: a monitoring system (Figure 1, control unit 16) comprising: at least one non-invasive sensor configured to gather data associated with at least one aspect of a person that is indicative of the respiratory distress state (0034 states “sound signals generated by microphone 60 in order for the sound recognition routine 96 to determine whether an audible event was due to a cough by patient 8 as compared with, say, a sneeze or a clearing of the throat by patient 8.”);
and a respiratory assessment module (processing system 32) operable to process data gathered by said at least one non-invasive sensor to determine whether the person is in the respiratory distress state (0033 states “microphone 60 may generate electronic signals representative of frequencies of vibrations of the air within cannula 28 that can occur when patient 8 coughs. Possibly additionally, pressure sensor 56 may generate electronic signals representative of fluid pressures within cannula 28, with the fluid pressures changing in accordance with a particular transient characteristic indicative of a cough in patient 8. The sound recognition routine 96 may include one or more signature signals that are representative of the audible content of a cough, such as a cough by patient 8 or a generic cough signature signal, with such signature signals being compared with the sound signals generated by microphone 60”);
and an oxygen delivery control module operable to transmit a control signal (0023 states “Control unit 16 typically is in operative control of valve 24”) configured to control a flow of oxygen from an oxygen source (oxygen source 20) as a function of data gathered by said at least one sensor of said monitoring system (0032 states “the flow of oxygen to patient 8 being reduced or curtailed during exhalation events via control of valve 24, by way of example. The breathing detection routine 96 may additionally or alternatively be used to determine from the duration and timing between exhalation and inhalation events to determine whether patient 8 is sleeping and, if so, to changes the flow/pressure of the oxygen within cannula 28 by controlled operation of valve 24, again by way of example.”).
Regarding claim 2, Holder teaches the system of claim 1, wherein said at least one non-invasive sensor comprises a touchless sensor selected from a group consisting of an imaging device and a microphone (microphone 60).
Regarding claim 4, Holder teaches the system of claim 1, wherein said at least one non-invasive sensor comprises a touchless sensor selected from a group consisting of an imaging device and a microphone (Microphone 60).
Regarding claim 7, Holder teaches the system of claim 1, wherein said respiratory assessment module is operable to process data gathered by a microphone sensor to detect a sign of respiratory distress selected from a group consisting of a chest movement, a paradoxical respiration, a breathing noise, a stertor noise, a stridor noise, a wheezing noise and a grunting noise (0008 states “Such a detection is performed monitoring audible events using the same cannula that is in fluid communication with the airways of the patient to deliver the supplemental gas, such as oxygen. The audible events may be, for instance, indicative of coughs in the patient. A change in the relative frequency of coughs in the patient may be identified by the routines as being indicative of an onset of an exacerbation.”).
Regarding claim 8, Holder teaches the system of claim 1, wherein said at least one non-invasive sensor comprises a low-touch sensor operable to gather biometric data (0026 states “pressure sensor 56 is of a type that is configured to detect an instantaneous or static pressure differential, such as between a detected pressure and a reference pressure.”).
Regarding claim 9, Holder teaches the system of claim 1, wherein said at least one non-invasive sensor comprises a low-touch sensor operable to gather biometric data selected from a group consisting of a saturation of oxygen in blood, a saturation of carbon dioxide in blood, a heart rate, and a breathing sound (0041 states “Microphone 60 and also possibly pressure sensor 56 detect, as at 110, conditions within the interior of cannula 28 that occur due to audible events, such as coughs by patient 8, as suggested above. In this regard, it is reiterated that the audible events that can be used in detecting an exacerbation of a medical condition are not merely limited to those resulting from coughs and can include, by way of example, those responsive to wheezing instances, crackling instances, sneezing instances, snoring instances, and potentially can also be responsive to intentional audible events generated by patient 8, such as through the use of humming, speaking a predetermined word, and the like.”), and a respiration rate.
Regarding claim 10, Holder teaches the system of claim 1, wherein said at least one non-invasive sensors comprises: a housing adapted to be supported on a human body (Sensor apparatus 52 is supported on the human body through cannula 28), said housing defining a closed internal cavity (Sensors 56 and 60 are depicted as being located within a cavity in figure 2); data acquisition hardware supported on the housing in the internal cavity (Processor 44); a data transmission module supported on the housing in the internal cavity, said data transmission module being operable to transmit data wirelessly from said at least one non-invasive sensor (wireless transmitter 72); and a power source supported on the housing in the internal cavity, said power source being operatively coupled to said data acquisition hardware and said data transmission module (A power source would be inherent as it is needed to power the system).
Regarding claim 11, Holder teaches the system of claim 1, wherein said oxygen delivery control module is integrated into an oxygen delivery system comprising: an oxygen source (Figure 1, oxygen source 20); and an oxygen delivery appliance adapted to deliver oxygen from said oxygen source (Cannula 28).
Regarding claim 12, Holder teaches the system of claim 11, wherein said oxygen delivery appliance adapted to deliver oxygen from said oxygen source comprises at least one of a wearable nasal cannula and a wearable oxygen mask (Cannula 28).
Regarding claim 14, Holder teaches the system of claim 1, wherein said an oxygen delivery control module operable control the flow of oxygen from the oxygen source as a function of data gathered by said at least one sensor of said monitoring system by comparing a current metric indicative of a current respiratory distress level to a predetermined threshold level associated with a respiratory state (0034 states “the sound recognition routine 96 may include one or more signature signals that are representative of the audible content of a cough, such as a cough by patient 8 or a generic cough signature signal, with such signature signals being compared with the sound signals generated by microphone 60 in order for the sound recognition routine 96 to determine whether an audible event was due to a cough by patient 8 as compared with, say, a sneeze or a clearing of the throat by patient 8” Also 0030 states “Pressure sensor 56 can sense within the interior of cannula 28 a pressure that is in comparison with a reference pressure such as ambient pressure”).
Regarding claim 15, Holder teaches the system of claim 1, wherein said an oxygen delivery control module operable control the flow of oxygen from the oxygen source to increase at least one of an oxygen concentration, a gas flow rate and a gas pressure when the person is determined to be in the respiratory distress state (0032 states “The breathing detection routine 96 may additionally or alternatively be used to determine from the duration and timing between exhalation and inhalation events to determine whether patient 8 is sleeping and, if so, to changes the flow/pressure of the oxygen within cannula 28 by controlled operation of valve 24, again by way of example. Other uses of the breathing detection routine 96 can be envisioned. The change in pressure can be any appropriate change, such as an increase or a decrease in the flow/pressure”).
Regarding claim 17, Holder teaches a sensor-based system for monitoring a person's breathing to automatedly detect a state of respiratory distress, and for automatedly adjusting oxygen delivery to the person to mitigate the respiratory distress state (The abstract states “An method and system for supplemental gas delivery that enables the identification of a need of therapeutic attention for patient receiving the supplemental gas (20) by detecting an onset of an exacerbation of a medical condition. Such a detection is performed by detecting audible events using a microphone (60) that is in fluid communication with a cannula (28) that is used to communicate the supplemental gas (20) with the airways of the patient (8).” 0032 discusses the control of oxygen supply.), the system comprising: a processor operable to execute instructions (processor 44); a memory operatively coupled to the processor (storage 48); and instructions stored in the memory and executable by the processor (0024 states “Storage 48 can be any of a wide variety of storage devices that can interface with processor 44 and which can include, for example and without limitation, RAM, ROM, EPROM, EEPROM, FLASH, etc., on which a number of routines or data or both can be stored for processing by processor 44.”) to: receive data from at least one non-invasive sensor configured to gather data associated with at least one aspect of a person that is useful in determining whether the person is in the respiratory distress state (0034 states “sound signals generated by microphone 60 in order for the sound recognition routine 96 to determine whether an audible event was due to a cough by patient 8 as compared with, say, a sneeze or a clearing of the throat by patient 8.”); and process data gathered by said at least one non-invasive sensor to determine whether the person is in the respiratory distress state (0013 states “he processor receives the output from the pressure sensor and microphone and detects audible events based on the output from at least the microphone. The processor then determines whether the patient is experiencing an onset of an exacerbation of a medical condition based on the monitored audible events”).
Regarding claim 18, Holder teaches the system of claim 17, further comprising instructions stored in the memory and executable by the processor to: store data indicating whether the person is in the respiratory distress state as medical record data (0035 states “it is particularly noted that an exacerbation detection routine 96 is also stored in storage 48 for execution on processor 44 and that is configured to employ output such as those from the breathing detection routine 96 or the sound recognition routine 96 or both to detect an onset of an exacerbation of a medical condition such as COPD or other medical condition.”).
Regarding claim 19, the system of claim 17, further comprising: a display device; and instructions stored in the memory and executable by the processor to display information indicating whether the person is in the respiratory distress state (0027 states “he exemplary output apparatus 40 depicted herein includes a visual display 68, a wireless transceiver 72, and an output port 76 that is connected with a removable array of storage media 80. Display 68 can be, for instance, a display such as an LCD display or other type of display, and may include the visual component of a touch-sensitive display of the type suggested above.”).
Regarding claim 20, Holder teaches the system of claim 17, further comprising: instructions stored in the memory and executable by the process to transmit a signal to issue a notification as at least one of an audible signal, a data transmission, and a notification message (0027 states “Alternatively, display 68 may be in the form of one or more warning light that can be triggered to be illuminated or to flash depending upon instructions generated by processing system 32.”).
Regarding claim 21, Holder teaches a method for monitoring a person's breathing to automatedly detect a state of respiratory distress (The abstract states “An method and system for supplemental gas delivery that enables the identification of a need of therapeutic attention for patient receiving the supplemental gas (20) by detecting an onset of an exacerbation of a medical condition. Such a detection is performed by detecting audible events using a microphone (60) that is in fluid communication with a cannula (28) that is used to communicate the supplemental gas (20) with the airways of the patient (8).”), and for automatedly adjusting oxygen delivery to the person to mitigate the respiratory distress state (0032 states “the flow of oxygen to patient 8 being reduced or curtailed during exhalation events via control of valve 24, by way of example”), the method comprising: monitoring a person for a state of respiratory distress with a non-invasive sensor configured to capture sensor data associated with the person (0034 states “sound signals generated by microphone 60 in order for the sound recognition routine 96 to determine whether an audible event was due to a cough by patient 8 as compared with, say, a sneeze or a clearing of the throat by patient 8.”); processing the sensor data to determine whether the person is currently in the respiratory distress state (0013 states “he processor receives the output from the pressure sensor and microphone and detects audible events based on the output from at least the microphone. The processor then determines whether the patient is experiencing an onset of an exacerbation of a medical condition based on the monitored audible events”); and if the person is currently in the state of respiratory distress, then: transmitting a first control signal to an oxygen flow control module to control a flow of oxygen from an oxygen source to the person by increasing at least one of an oxygen concentration in a gas flow, a gas flow rate, and a gas flow pressure of the gas flow (0032 states “The breathing detection routine 96 may additionally or alternatively be used to determine from the duration and timing between exhalation and inhalation events to determine whether patient 8 is sleeping and, if so, to changes the flow/pressure of the oxygen within cannula 28 by controlled operation of valve 24, again by way of example. Other uses of the breathing detection routine 96 can be envisioned. The change in pressure can be any appropriate change, such as an increase or a decrease in the flow/pressure.”).
Regarding claim 24, Holder teaches the method of claim 21, wherein monitoring the person for the state of respiratory distress comprises using a microphone sensor to detect a sign of respiratory distress selected from a group consisting of a chest movement, a paradoxical respiration, a breathing noise, a stertor noise, a stridor noise, a wheezing noise and a grunting noise (0008 states “Such a detection is performed monitoring audible events using the same cannula that is in fluid communication with the airways of the patient to deliver the supplemental gas, such as oxygen. The audible events may be, for instance, indicative of coughs in the patient. A change in the relative frequency of coughs in the patient may be identified by the routines as being indicative of an onset of an exacerbation.”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Holder in view of Kolarovic et al. 2002/0173696
Regarding claim 3, Holder teaches the system of claim 1, but fails to teach
wherein said at least one non-invasive sensor comprises a digital video camera. Kolarovic teaches an analogous infant incubator that does teach wherein said at least one non-invasive sensor comprises a digital video camera (Video camera 32, figure 1). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holder with the teachings of Kolarovic and include wherein said at least one non-invasive sensor comprises a digital video camera as this allows for monitoring of physical parameters of the patient (0021).
Regarding claim 5, Holder teaches the system of claim 4, but fails to teach wherein said at least one non-invasive sensor is supported on an infant isolette in a position to gather data from an infant positioned within the isolette. Kolarovic does teach at least one non-invasive sensor is supported on an infant isolette (Video camera 32 is mounted on the isolette as depicted in figure 1) in a position to gather data from an infant positioned within the isolette (0021 states “Video camera 32 is coupled to a system 64, such as a computer running video signal processing software capable of monitoring physical parameters of infant 14 in incubator 10. Video signal processing software, capable of analyzing the video feed to determine the respiration rate of infant 14 is incorporated into system 16”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holder with the teachings of Kolarovic and include wherein said at least one non-invasive sensor is supported on an infant isolette in a position to gather data from an infant positioned within the isolette as this allows for monitoring of the patient to occur.
Claims 6, 13, 16, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Holder in view of Mansfield et al. 2023/0320675
Regarding claim 6, Holder teaches the system of claim 1, but fails to teach wherein said respiratory assessment module is operable to process data gathered by a camera sensor to detect a sign of respiratory distress selected from a group consisting of a chest movement, an abdominal movement, and a flaring of nostrils. Pepin teaches an analogous CPAP therapy method that does teach wherein said respiratory assessment module is operable to process data gathered by a camera sensor to detect a sign of respiratory distress selected from a group consisting of a chest movement, an abdominal movement, and a flaring of nostrils (0048 states “A camera may be used to monitor chest movement and the controller 110 may detect sleep apnea events if monitored chest movements deviate from a regular cycle, or stop entirely for a period of time”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holder with the teachings of Pepin and include wherein said respiratory assessment module is operable to process data gathered by a camera sensor to detect a sign of respiratory distress selected from a group consisting of a chest movement, an abdominal movement, and a flaring of nostrils as this allows for the detection of certain events in relation to the status of the user (0048).
Regarding claim 13, Holder teaches the system of claim 11, but fails to explicitly teach wherein said oxygen delivery system is configured as one of an oxygen blender operable to increase and decrease an oxygen concentration in a flow of a gas, a non-invasive continuous ventilator operable to increase and decrease a flow rate of the flow of gas and a positive-pressure gas delivery system operable to increase and decrease a pressure of the flow of gas. Mansfield teaches an analogous airway management system that does teach a non-invasive continuous ventilator operable to increase and decrease a flow rate of the flow of gas (0027 states “the ventilator 22 includes a gas mixture controller 74 that provides control instructions to cause the ventilator 22 to continuously or intermittently adjust a pressure and/or a composition of the gas mixture 70 provided from the source 72 and to the patient 40.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holder with the teachings of Mansfield and include a non-invasive continuous ventilator operable to increase and decrease a flow rate of the flow of gas as this will allow for an adjustment of patient input based on the current state of the patient.
Regarding claim 16, Holder teaches the system of claim 15, but fails to teach wherein an oxygen delivery control module operable control the flow of oxygen from the oxygen source to decrease at least one of the oxygen concentration, the gas flow rate, and the gas pressure when the person is determined to not be in the respiratory distress state. Mansfield does teach wherein said an oxygen delivery control module operable control the flow of oxygen from the oxygen source to decrease at least one of the oxygen concentration, the gas flow rate, and the gas pressure when the person is determined to not be in the respiratory distress state (0071 states “The increase in pressure may be in the form of an increase in PEEP to help maintain the airway in an expanded state. The increase in pressure may be for a set period of time or continue until the tracheal collapse (or other obstruction event) has resolved or ended.” Once the obstruction event has resolved, the gas pressure will decrease back to its original state. 0075 states “if the ventilation was adjusted in operation 518, the ventilation may be adjusted back to the ventilation parameters that were being utilized prior to the adjustment due to the detection of the airway obstruction event.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holder with the teachings of Mansfield and include wherein an oxygen delivery control module operable control the flow of oxygen from the oxygen source to decrease at least one of the oxygen concentration, the gas flow rate, and the gas pressure when the person is determined to not be in the respiratory distress state as this allows for the input to go back to its original state once an abnormality is not detected anymore (0071).
Regarding claim 22, Holder teaches the method of claim 21, further comprising: continuing to monitor the person for the respiratory distress state with the non- invasive sensor configured to capture additional sensor data associated with the person (0034 states “sound signals generated by microphone 60 in order for the sound recognition routine 96 to determine whether an audible event was due to a cough by patient 8 as compared with, say, a sneeze or a clearing of the throat by patient 8.”); processing the additional sensor data to determine whether the person is currently in the respiratory distress state (0013 states “he processor receives the output from the pressure sensor and microphone and detects audible events based on the output from at least the microphone. The processor then determines whether the patient is experiencing an onset of an exacerbation of a medical condition based on the monitored audible events”); but fails to explicitly teach wherein if the person is not currently in the state of respiratory distress, then: transmitting a second control signal to the oxygen flow control module to control the flow of oxygen from the oxygen source to the person by decreasing at least one of the oxygen concentration in the gas flow, the gas flow rate, and the gas flow pressure of the gas flow. Mansfield does teach wherein if the person is not currently in the state of respiratory distress, then: transmitting a second control signal to the oxygen flow control module to control the flow of oxygen from the oxygen source (0074 states “At operation 520, an end of the obstruction event is detected. In some examples, the obstruction event, such as a tracheal collapse or a mucus plug, may resolve itself or end. The end of the obstruction event may be determined based on the passageway size being greater than the inner diameter size of the lumen for a threshold period of time. The threshold period of time may be greater than the threshold period of time for determining an airway obstruction has occurred. The determination of the passageway size being greater than the inner diameter of the lumen may be based on the time series of passageway sizes and/or the polarity of the detected echoes”) to the person by decreasing at least one of the oxygen concentration in the gas flow, the gas flow rate, and the gas flow pressure of the gas flow (0071 states “The increase in pressure may be in the form of an increase in PEEP to help maintain the airway in an expanded state. The increase in pressure may be for a set period of time or continue until the tracheal collapse (or other obstruction event) has resolved or ended.” 0075 states “if the ventilation was adjusted in operation 518, the ventilation may be adjusted back to the ventilation parameters that were being utilized prior to the adjustment due to the detection of the airway obstruction event..”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holder with the teachings of Mansfield and include wherein if the person is not currently in the state of respiratory distress, then: transmitting a second control signal to the oxygen flow control module to control the flow of oxygen from the oxygen source as this will allow for a return to baseline levels of ventilation parameters (0075).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Holder in view of Pepin et al. 2019/0150829
Regarding claim 23, Holder teaches the method of claim 21, but fails to teach wherein monitoring the person for the state of respiratory distress comprises using a camera sensor to detect a sign of respiratory distress selected from a group consisting of a chest movement, an abdominal movement, and a flaring of nostrils. Pepin does teach wherein said respiratory assessment module is operable to process data gathered by a camera sensor to detect a sign of respiratory distress selected from a group consisting of a chest movement, an abdominal movement, and a flaring of nostrils (0048 states “A camera may be used to monitor chest movement and the controller 110 may detect sleep apnea events if monitored chest movements deviate from a regular cycle, or stop entirely for a period of time”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holder with the teachings of Pepin and include wherein said respiratory assessment module is operable to process data gathered by a camera sensor to detect a sign of respiratory distress selected from a group consisting of a chest movement, an abdominal movement, and a flaring of nostrils as this allows for the detection of certain events in relation to the status of the user (0048).
Conclusion
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/ROHAN PATEL/ Examiner, Art Unit 3785
/BRANDY S LEE/ Supervisory Patent Examiner, Art Unit 3785
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