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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 7, 10, 12, 15, 21, 23, 25-27, 37, 40-42, 44, 46, 48, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Holley et al. EP 2,396,062, in view of Truschel et al. 2020/0046924 and Chamtie et al. WO2019006496
Regarding claim 1, Holley teaches a method for diagnosing an operational issue in a respiratory therapy system (abstract states “detection of obstruction”), comprising: receiving, via an external device (0064 states “the obstruction detection apparatus 102 may serve as a detector that is used with, but structurally independent of, a respiratory treatment apparatus”), a command to begin diagnosing the operational issue in the respiratory therapy system (0061 states “of the detector such as to initiate a pre-measuring process, select premeasured tube data, initiate an obstruction measuring process, etc. may be performed in conjunction with a user interface such as input switches that operate the controller or processor of the detection apparatus.”); causing one or more sensors of the external device to generate acoustic data (0066 states “The device may also include a sensor or data interface 1214, such as a bus, for receiving/transmitting data such as programming instructions, settings data, sound data, microphone sound samples, acoustic measurement data, obstruction information, etc.”), the acoustic data being indicative of one or more sounds emanating from the respiratory therapy system (0014 states “a respiratory treatment conduit obstruction by determining with a sound sensor a measure of sound of a flow generator within a respiratory treatment conduit, such as an endotracheal tube. The measure of sound is then be analyzed with a processor. The processor then indicates a presence or absence of obstruction in the respiratory treatment conduit based on the analyzing.”); and analyzing at least a portion of the generated acoustic data to identify (i) a location of the operational issue in the respiratory therapy system (0016 states “a location and extent of the presence of obstruction based on data of the difference calculating may be determined”), (ii) one or more causes of the operational issue in the respiratory therapy system (0014 states “The processor then indicates a presence or absence of obstruction in the respiratory treatment conduit based on the analyzing.”), or (iii) both (i) and (ii).
Holley fails to teach a generation of image data with the image data being reproducible as one or more images, and analyzing at least a portion of the image data to identify (i) a location of the operational issue in the respiratory therapy system, (ii) one or more causes of the operational issue in the respiratory therapy system, or (iii) both (i) and (ii) and performing an action in response to identifying the location of the operational issue, the one or more causes of the operational issue, or both, the action including:(i) instructing a user of the respiratory therapy system, via the external device, to remove or replace a component of the respiratory therapy system that is identified as the location or one of the one or more causes of the operational issue;(ii) adjusting one or more settings of the respiratory therapy system;(iii) transmitting a notification to a third party indicative of a presence of the operational issue, the location of the operational, the one or more causes of the operational issue, or any combination thereof; or (iv) any combination of (i)-(iii).
Truschel teaches an analogous ventilation imaging and diagnostic system that does teach a generation of image data and the image data being reproducible as one or more images (0033 states “The camera 14 can comprise any suitable camera configured to capture images of at least two or more of (i) the ventilator source 12, (ii) one or more component of the first plurality of ventilation components in the ventilation circuit 34, and (iii) the patient 40”), and analyzing at least a portion of the image data (0012 states “the method further comprises analyzing, via the component recognition and identification module, at least one captured image to recognize or identify at least two or more of (i) the ventilator source, (ii) one or more component of the first plurality of ventilator components, and (iii) one or more characteristic of the patient”) to identify (i) a location of the operational issue in the respiratory therapy system, (ii) one or more causes of the operational issue in the respiratory therapy system (0005 states “the controller includes at least (i) a control module, (ii) a component recognition and identification module, (iii) a component tracking module configured to track targets within a plurality of real-time images captured via the camera and to detect at least one change in tracked targets, and (iv) a ventilation compensation module. The control module is configured to control an operation of the ventilator source with operating parameters determined as a function of at least (i) a gas composition algorithm, (ii) an output of the component recognition and identification module, and (iii) an output of the ventilation compensation module determined as a function of an output of the component tracking module, wherein responsive to the operating parameters, the ventilator source outputs the ventilation gas with one or more ventilation properties.”), or (iii) both (i) and (ii).
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 the external device of Holley with the teachings of Truschel and include a generation and analyzing of image data to diagnose issues with the respiratory therapy system as this allows for the use of image recognition software to adjust the operating status of the ventilator based on component identification tags (0016 and 0032). Further motivation is found in Chamtie WO 2019/006496, which discloses a similar acoustic measurement system, however the external device conducting acoustic receiving is mentioned as being a smartphone (0151). Since smartphones contain cameras, a modification of the concept of image tracking as taught by Truschel can be implemented into an external acoustic receiving system, such as the one taught by Holley, to allow for further diagnostic capabilities.
Modified Holley still fails to teach performing an action in response to identifying the location of the operational issue, the one or more causes of the operational issue, or both, the action including:(i) instructing a user of the respiratory therapy system, via the external device, to remove or replace a component of the respiratory therapy system that is identified as the location or one of the one or more causes of the operational issue;(ii) adjusting one or more settings of the respiratory therapy system;(iii) transmitting a notification to a third party indicative of a presence of the operational issue, the location of the operational, the one or more causes of the operational issue, or any combination thereof; or (iv) any combination of (i)-(iii).
Chamtie does teach an analogous respiratory acoustic measuring system that does teach performing an action in response to identifying the location of the operational issue, the one or more causes of the operational issue (0214 discusses the use of a component requiring replacement), or both, the action including:(i) instructing a user of the respiratory therapy system, via the external device (0134 states “External transducers may be for example located on a patient interface, or in an external computing device, such as a smartphone”), to remove or replace a component of the respiratory therapy system that is identified as the location or one of the one or more causes of the operational issue (0218 states “the patient 1000 may advantageously be provided with a reminder that their patient interface has exceeded its recommended useable life and may require replacement to ensure adequacy of the respiratory therapy required according to the patient's needs.”); (ii) adjusting one or more settings of the respiratory therapy system (0199 states “a processor may be configured to determine, set or change an operational parameter (e.g., vent flow characteristics, flow rate setting, pressure setting) or monitor data (e.g., compliance information, component useful life) related to the respiratory therapy system based on the determined parameter(s)”); (iii) transmitting a notification to a third party indicative of a presence of the operational issue, the location of the operational, the one or more causes of the operational issue, or any combination thereof (0214 states “an equipment provider may be able to be notified that a component may require replacement, and/or a technician may be able to view the data and help the patient to troubleshoot any problems that they may be having with the RPT system or therapy”); or (iv) any combination of (i)-(iii).
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 modified Holley with the teachings of Chamtie and include this notification of an operational issue as it ensures that the system is taking advantage of the component being used (0022) and the patient isn’t receiving less than adequate therapy from a degenerated device (0215).
Regarding claim 4, Holley teaches the method of claim 1, wherein the analyzing the at least the portion of the generated acoustic data includes identifying one or more components of the respiratory therapy system that are associated with the operational issue (0078 states “The present technology may provide improvements to known apparatus to facilitate the coordination between the flow generator and the peripheral components based on acoustic detection to distinguish or identify particular components.”).
Regarding claim 7, Holley teaches the method claim1, wherein the one or more sensors of the external device further include (i) a microphone configured to generate or detect at least a portion of the acoustic data (0016 states “According to the invention the sound source that generates the sound within the respiratory treatment conduit is a flow generator. Still further, the sound sensor may be a single microphone.”), (ii) a speaker configured to generate or emit sound waves, where the microphone is further configured to detect reflections of the generated or emitted sound waves from the speaker (0142 states “, in some examples, a speaker or horn driver may be implemented in the conduit to generate the sound impulse that is recorded by the sound sensor.”), or (iii) a combination thereof.
Regarding claim 10, modified Holley teaches the method of claim 1, further comprising: analyzing at least a portion of the generated image data to confirm (i) the identified location of the operational issue in the respiratory therapy system, (ii) the identified one or more causes of the operational issue in the respiratory therapy system (0007 of Truschel states “In addition, the component tracking module is further configured to detect at least one change in the one or more interrelationship, connection, or physical condition of the tracked targets. Furthermore, the output of the component tracking module includes data indicative of the at least one detected change in the one or more interrelationship, connection, or physical condition of the tracked targets.”), or (iii) both (i) and (ii).
Regarding claim 12, modified Holley teaches the method of claim 1, further comprising: scanning, via a camera of the external device, one or more identifiers of the respiratory therapy system (0017 of Truschel states “Packaged ventilation circuit items may also be held near the camera for scanning of the ventilation components and/or patient interface manufacturers' bar codes before placing a respective component into the ventilation circuit to pre-load the image recognition/processing algorithm with the scanned components.”).
Regarding claim 15, modified Holley teaches the method of claim 12, wherein the one or more identifiers are associated with one or more components of the respiratory therapy system, and wherein the one or more components of the respiratory therapy system includes a respiratory therapy device (apparatus 10 of Truschel), a user interface (user interface 18), a conduit (36), a display device (interface 18), a humidifier, one or more sensors of the respiratory therapy system (sensors 46), or any combination thereof.
Regarding claim 21, Holley teaches the method of claim 1, wherein the analyzing the at least the portion of the generated acoustic data is based, at least in part, on a fast Fourier transform (FFT) analysis, a short time Fourier transform (STFT) analysis, a spectral analysis, a Cepstrum analysis, an autocepstrum analysis, an auto-correlation analysis, or any combination thereof (0015 and 0018 discuss the use of a Fourier transform and cepstrum as methods of analyzing the acoustic data.).
Regarding claim 23, Holley teaches the method of claim 1, wherein the analyzing the at least the portion of the generated acoustic data includes identifying a plurality of features for the at least the portion of the generated acoustic data (0015 states “he analyzing may also involve calculating a difference between (a) the inverse transform of the logarithm of the transformed data samples representing the measure of sound and (b) an inverse transform of a logarithm of Fourier transformed data samples representing a sound measured from an unobstructed version of the respiratory treatment conduit.”).
Regarding claim 25, Holley teaches the method of claim 1, further comprising: responsive to the identified one or more causes of the operational issue in the respiratory therapy system, adjusting one or more settings of the respiratory therapy system (0067 states “At 1224, these may also include stored processor control instructions for flow generator control, such as respiratory treatment control based on feedback processing and measuring process settings adjustment, etc.”).
Regarding claim 26, Holley teaches the method of claim 25, wherein the adjusting one or more settings of the respiratory therapy system includes (i) preventing the respiratory therapy system from turning on, (ii) preventing one or more components of the respiratory therapy system from turning on (Paragraph 0116 states “operations may be permitted or prevented by sending an enable or disable signal(s) from the authorization controller 19-106 to another controller of the device.”)
or (iii) both (i) and (ii).
Regarding claim 27, Holley teaches the method of claim 1, further comprising: responsive to the analyzing the at least the portion of the generated acoustic data, causing a notification to be provided, via the external device, to a user of the respiratory therapy system (0061 states “The detector may even trigger a warning message and/or alarm in the event of the detection of a substantial obstruction, such that it may recommend or warn of the need of replacement or cleaning of a current endotracheal tube in use”).
Regarding claim 37, Holley teaches the method of claim 1, further comprising: receiving, from an internal microphone of the respiratory therapy system, acoustic data associated with a user of the respiratory therapy system during a respiratory therapy session; and differentiating the acoustic data generated by the one or more sensors of the external device from the acoustic data received from the internal microphone of the respiratory therapy system to exclude sounds of a user undergoing the respiratory therapy session (0076 states “In some embodiments, the frequency domain may be processed to isolate or emphasize data of interest in detecting a particular condition or system accessory. For example, the process may involve filtering with respect to particular frequencies (e.g., low pass, high pass, band pass, etc.). In this regard, it may be useful to include or exclude certain spectral components such as filtering out spectral components to exclude frequencies not particularly related to a detection of interest. For example, frequencies associated with snoring sounds or leak sounds may be filtered out to assist in mask detection or other patient condition detection.”).
Regarding claim 40, Holley teaches the method of claim 1, further comprising: receiving, from an internal microphone of the respiratory therapy system, internal acoustic data associated with a user of the respiratory therapy system (0106 states “some embodiments may also detect and measure the reflections or echoes returned from the patient's own respiratory system that is connected to the patient interface. For example, the embodied systems, methods, and devices may detect and identify the state, and conditioning of the patient's respiratory system or even an identity thereof for authentication purpose”).
Regarding claim 41, Holley teaches the method of claim 40, further comprising: analyzing at least a portion of the received internal acoustic data to confirm (i) the identified location of the operational issue in the respiratory therapy system (0107 states “the present technology may permit an apparatus to discern the location of a leak in addition to whether a leak has occurred.”), (ii) the identified one or more causes of the operational issue in the respiratory therapy system (0106 states “the apparatus may be implemented to detect the diameter of airways of a patient at any given point or points. Using the same or similar technique as previously discussed, closed airways or increased resistance in the patient's airways may be detected. Furthermore, the embodiments may also be able to detect whether the patient's mouth is open during CPAP treatment.”), or (iii) both (i) and (ii).
Regarding claim 42, Holley teaches the method of claim 40, wherein the internal acoustic data associated with the user of the respiratory therapy system is received from the internal microphone in response to analyzing the acoustic data generated by the one or more sensors of the external device (0106 states “some embodiments may also detect and measure the reflections or echoes returned from the patient's own respiratory system that is connected to the patient interface. For example, the embodied systems, methods, and devices may detect and identify the state, and conditioning of the patient's respiratory system or even an identity thereof for authentication purpose”), and the command to begin diagnosing the operational issue in the respiratory therapy system is generated in response to analyzing at least a portion of the received internal acoustic data (0107 states “the leak may be identified and/or quantified by examination of cepstrum data such as comparing known stored cepstrum data representative of a leak to a current test cepstrum data. Once the leak is identified from the cepstrum data, the location (e.g., based on the timing of the leak related data in the cepstrum data) may be detected and a suitable response by the device may be made.”).
Regarding claim 44, Holley teaches the method of claim 1, further comprising receiving, via the external device, user input associated with the respiratory therapy system, wherein (i) the location of the operational issue in the respiratory therapy system, (ii) the one or more causes of the operational issue in the respiratory therapy system, or (iii) both (i) and (ii) are identified based at least in part on the received user input (0066 states “A user control/input interface 1212, for example, for a keyboard, touch panel, control buttons, mouse etc. may also be included as previously discussed and for inputting data, or otherwise activating or operating the methodologies described herein”. This is stating the use of user input to operate the device and activate the methods that have already been described (0014, 0016, 0106, 0107) of locating and identifying the operational issues.).
Regarding claim 46, Holley teaches a system comprising: a control system including one or more processors (0019 states “The apparatus may also include a controller or processor configured to analyze data samples of the measure of sound from the microphone by calculation of a cepstrum with the data samples of the measure of sound.”); and a memory having stored thereon machine readable instructions; wherein the control system is coupled to the memory, and the one or more processors are configured to execute the machine readable instructions (0046 states “Thus, the controller may include integrated chips, a memory and/or other control instruction, data or information storage medium. For example, programmed instructions encompassing such a detection methodology may be coded on integrated chips in the memory of the device. Such instructions may also or alternatively be loaded as software or firmware using an appropriate data storage medium. With such a controller or processor, the device can be used for determining and analyzing sound data from the sound sensor. Thus, the processor may control the assessment of obstruction as described in the embodiments discussed in more detail herein.”); to: receive, via an external device (0064 states “the obstruction detection apparatus 102 may serve as a detector that is used with, but structurally independent of, a respiratory treatment apparatus”), a command to begin diagnosing an operational issue in a respiratory therapy system (0061 states “of the detector such as to initiate a pre-measuring process, select premeasured tube data, initiate an obstruction measuring process, etc. may be performed in conjunction with a user interface such as input switches that operate the controller or processor of the detection apparatus.”); cause one or more sensors of the external device to generate acoustic data (0066 states “The device may also include a sensor or data interface 1214, such as a bus, for receiving/transmitting data such as programming instructions, settings data, sound data, microphone sound samples, acoustic measurement data, obstruction information, etc.”), the acoustic data being indicative of one or more sounds emanating from the respiratory therapy system (0014 states “a respiratory treatment conduit obstruction by determining with a sound sensor a measure of sound of a flow generator within a respiratory treatment conduit, such as an endotracheal tube. The measure of sound is then be analyzed with a processor. The processor then indicates a presence or absence of obstruction in the respiratory treatment conduit based on the analyzing.”); and analyzing at least a portion of the generated acoustic data to identify (i) a location of the operational issue in the respiratory therapy system (0016 states “a location and extent of the presence of obstruction based on data of the difference calculating may be determined”), (ii) one or more causes of the operational issue in the respiratory therapy system (0014 states “The processor then indicates a presence or absence of obstruction in the respiratory treatment conduit based on the analyzing.”), or (iii) both (i) and (ii).
Holley fails to teach one or more sensors generating image data with the image data being reproducible as one or more images, and analyzing at least a portion of the image data to identify (i) a location of the operational issue in the respiratory therapy system, (ii) one or more causes of the operational issue in the respiratory therapy system, or (iii) both (i) and (ii).
Truschel does teach causing one or more sensors of the external device to generate acoustic data and image data and the image data being reproducible as one or more images (0033 states “The camera 14 can comprise any suitable camera configured to capture images of at least two or more of (i) the ventilator source 12, (ii) one or more component of the first plurality of ventilation components in the ventilation circuit 34, and (iii) the patient 40”); and analyzing at least a portion of the image data (0012 states “the method further comprises analyzing, via the component recognition and identification module, at least one captured image to recognize or identify at least two or more of (i) the ventilator source, (ii) one or more component of the first plurality of ventilator components, and (iii) one or more characteristic of the patient”) to identify (i) a location of the operational issue in the respiratory therapy system, (ii) one or more causes of the operational issue in the respiratory therapy system (0005 states “the controller includes at least (i) a control module, (ii) a component recognition and identification module, (iii) a component tracking module configured to track targets within a plurality of real-time images captured via the camera and to detect at least one change in tracked targets, and (iv) a ventilation compensation module. The control module is configured to control an operation of the ventilator source with operating parameters determined as a function of at least (i) a gas composition algorithm, (ii) an output of the component recognition and identification module, and (iii) an output of the ventilation compensation module determined as a function of an output of the component tracking module, wherein responsive to the operating parameters, the ventilator source outputs the ventilation gas with one or more ventilation properties.”), or (iii) both (i) and (ii).
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 the external device of Holley with the teachings of Truschel and include a generation and analyzing of image data to diagnose issues with the respiratory therapy system as this allows for the use of image recognition software to adjust the operating status of the ventilator based on component identification tags (0016 and 0032). Further motivation is found in Chamtie WO 2019/006496, which discloses a similar acoustic measurement system, however the external device conducting acoustic receiving is mentioned as being a smartphone (0151). Since smartphones contain cameras, a modification of the concept of image tracking as taught by Truschel can be implemented into an external acoustic receiving system, such as the one taught by Holley, to allow for further diagnostic capabilities.
Modified Holley still fails to teach performing an action in response to identifying the location of the operational issue, the one or more causes of the operational issue, or both, the action including:(i) instructing a user of the respiratory therapy system, via the external device, to remove or replace a component of the respiratory therapy system that is identified as the location or one of the one or more causes of the operational issue;(ii) adjusting one or more settings of the respiratory therapy system;(iii) transmitting a notification to a third party indicative of a presence of the operational issue, the location of the operational, the one or more causes of the operational issue, or any combination thereof; or (iv) any combination of (i)-(iii).
Chamtie does teach an analogous respiratory acoustic measuring system that does teach performing an action in response to identifying the location of the operational issue, the one or more causes of the operational issue (0214 discusses the use of a component requiring replacement), or both, the action including:(i) instructing a user of the respiratory therapy system, via the external device (0134 states “External transducers may be for example located on a patient interface, or in an external computing device, such as a smartphone”), to remove or replace a component of the respiratory therapy system that is identified as the location or one of the one or more causes of the operational issue (0218 states “the patient 1000 may advantageously be provided with a reminder that their patient interface has exceeded its recommended useable life and may require replacement to ensure adequacy of the respiratory therapy required according to the patient's needs.”); (ii) adjusting one or more settings of the respiratory therapy system (0199 states “a processor may be configured to determine, set or change an operational parameter (e.g., vent flow characteristics, flow rate setting, pressure setting) or monitor data (e.g., compliance information, component useful life) related to the respiratory therapy system based on the determined parameter(s)”); (iii) transmitting a notification to a third party indicative of a presence of the operational issue, the location of the operational, the one or more causes of the operational issue, or any combination thereof (0214 states “an equipment provider may be able to be notified that a component may require replacement, and/or a technician may be able to view the data and help the patient to troubleshoot any problems that they may be having with the RPT system or therapy”); or (iv) any combination of (i)-(iii).
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 modified Holley with the teachings of Chamtie and include this notification of an operational issue as it ensures that the system is taking advantage of the component being used (0022) and the patient isn’t receiving less than adequate therapy from a degenerated device (0215).
Regarding claim 48, Holley teaches a non-transitory computer readable storage medium storing machine readable instructions that, when executed by one or more processors of a control system (0019 states “The apparatus may also include a controller or processor configured to analyze data samples of the measure of sound from the microphone by calculation of a cepstrum with the data samples of the measure of sound.”), cause the one or more processors to: receive, via an external device (0064 states “the obstruction detection apparatus 102 may serve as a detector that is used with, but structurally independent of, a respiratory treatment apparatus”), a command to begin diagnosing an operational issue in a respiratory therapy system (0061 states “of the detector such as to initiate a pre-measuring process, select premeasured tube data, initiate an obstruction measuring process, etc. may be performed in conjunction with a user interface such as input switches that operate the controller or processor of the detection apparatus.”); cause one or more sensors of the external device to generate acoustic data (0066 states “The device may also include a sensor or data interface 1214, such as a bus, for receiving/transmitting data such as programming instructions, settings data, sound data, microphone sound samples, acoustic measurement data, obstruction information, etc.”), the acoustic data being indicative of one or more sounds emanating from the respiratory therapy system (0014 states “a respiratory treatment conduit obstruction by determining with a sound sensor a measure of sound of a flow generator within a respiratory treatment conduit, such as an endotracheal tube. The measure of sound is then be analyzed with a processor. The processor then indicates a presence or absence of obstruction in the respiratory treatment conduit based on the analyzing.”); and analyzing at least a portion of the generated acoustic data to identify (i) a location of the operational issue in the respiratory therapy system (0016 states “a location and extent of the presence of obstruction based on data of the difference calculating may be determined”), (ii) one or more causes of the operational issue in the respiratory therapy system (0014 states “The processor then indicates a presence or absence of obstruction in the respiratory treatment conduit based on the analyzing.”), or (iii) both (i) and (ii).
Holley fails to teach one or more sensors generating image data with the image data being reproducible as one or more images, and analyzing at least a portion of the image data to identify (i) a location of the operational issue in the respiratory therapy system, (ii) one or more causes of the operational issue in the respiratory therapy system, or (iii) both (i) and (ii).
Truschel does teach causing one or more sensors of the external device to generate acoustic data and image data and the image data being reproducible as one or more images (0033 states “The camera 14 can comprise any suitable camera configured to capture images of at least two or more of (i) the ventilator source 12, (ii) one or more component of the first plurality of ventilation components in the ventilation circuit 34, and (iii) the patient 40”); and analyzing at least a portion of the image data (0012 states “the method further comprises analyzing, via the component recognition and identification module, at least one captured image to recognize or identify at least two or more of (i) the ventilator source, (ii) one or more component of the first plurality of ventilator components, and (iii) one or more characteristic of the patient”) to identify (i) a location of the operational issue in the respiratory therapy system, (ii) one or more causes of the operational issue in the respiratory therapy system (0005 states “the controller includes at least (i) a control module, (ii) a component recognition and identification module, (iii) a component tracking module configured to track targets within a plurality of real-time images captured via the camera and to detect at least one change in tracked targets, and (iv) a ventilation compensation module. The control module is configured to control an operation of the ventilator source with operating parameters determined as a function of at least (i) a gas composition algorithm, (ii) an output of the component recognition and identification module, and (iii) an output of the ventilation compensation module determined as a function of an output of the component tracking module, wherein responsive to the operating parameters, the ventilator source outputs the ventilation gas with one or more ventilation properties.”), or (iii) both (i) and (ii).
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 the external device of Holley with the teachings of Truschel and include a generation and analyzing of image data to diagnose issues with the respiratory therapy system as this allows for the use of image recognition software to adjust the operating status of the ventilator based on component identification tags (0016 and 0032). Further motivation is found in Chamtie WO 2019/006496, which discloses a similar acoustic measurement system, however the external device conducting acoustic receiving is mentioned as being a smartphone (0151). Since smartphones contain cameras, a modification of the concept of image tracking as taught by Truschel can be implemented into an external acoustic receiving system, such as the one taught by Holley, to allow for further diagnostic capabilities.
Modified Holley still fails to teach performing an action in response to identifying the location of the operational issue, the one or more causes of the operational issue, or both, the action including:(i) instructing a user of the respiratory therapy system, via the external device, to remove or replace a component of the respiratory therapy system that is identified as the location or one of the one or more causes of the operational issue;(ii) adjusting one or more settings of the respiratory therapy system;(iii) transmitting a notification to a third party indicative of a presence of the operational issue, the location of the operational, the one or more causes of the operational issue, or any combination thereof; or (iv) any combination of (i)-(iii).
Chamtie does teach an analogous respiratory acoustic measuring system that does teach performing an action in response to identifying the location of the operational issue, the one or more causes of the operational issue (0214 discusses the use of a component requiring replacement), or both, the action including:(i) instructing a user of the respiratory therapy system, via the external device (0134 states “External transducers may be for example located on a patient interface, or in an external computing device, such as a smartphone”), to remove or replace a component of the respiratory therapy system that is identified as the location or one of the one or more causes of the operational issue (0218 states “the patient 1000 may advantageously be provided with a reminder that their patient interface has exceeded its recommended useable life and may require replacement to ensure adequacy of the respiratory therapy required according to the patient's needs.”); (ii) adjusting one or more settings of the respiratory therapy system (0199 states “a processor may be configured to determine, set or change an operational parameter (e.g., vent flow characteristics, flow rate setting, pressure setting) or monitor data (e.g., compliance information, component useful life) related to the respiratory therapy system based on the determined parameter(s)”); (iii) transmitting a notification to a third party indicative of a presence of the operational issue, the location of the operational, the one or more causes of the operational issue, or any combination thereof (0214 states “an equipment provider may be able to be notified that a component may require replacement, and/or a technician may be able to view the data and help the patient to troubleshoot any problems that they may be having with the RPT system or therapy”); or (iv) any combination of (i)-(iii).
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 modified Holley with the teachings of Chamtie and include this notification of an operational issue as it ensures that the system is taking advantage of the component being used (0022) and the patient isn’t receiving less than adequate therapy from a degenerated device (0215).
Regarding claim 50, modified Holley teaches the method of claim 1, wherein analyzing at least the portion of the generated acoustic data and the image data includes: analyzing at least a portion of the acoustic data to identify (i) the location of the operational issue in the respiratory therapy system, (0016 of Holley states “a location and extent of the presence of obstruction based on data of the difference calculating may be determined”), (ii) one or more causes of the operational issue in the respiratory therapy system (0014 of Holley states “The processor then indicates a presence or absence of obstruction in the respiratory treatment conduit based on the analyzing.”), or (iii) both (i) and (ii). and confirming, based on at least a portion of the image data, (i) the identified location of the operational issue in the respiratory therapy system, (ii) the identified one or more causes of the operational issue in the respiratory therapy system (0005 of Truschel states “the controller includes at least (i) a control module, (ii) a component recognition and identification module, (iii) a component tracking module configured to track targets within a plurality of real-time images captured via the camera and to detect at least one change in tracked targets, and (iv) a ventilation compensation module. The control module is configured to control an operation of the ventilator source with operating parameters determined as a function of at least (i) a gas composition algorithm, (ii) an output of the component recognition and identification module, and (iii) an output of the ventilation compensation module determined as a function of an output of the component tracking module, wherein responsive to the operating parameters, the ventilator source outputs the ventilation gas with one or more ventilation properties.”), or (iii) both (i) and (ii).
Claims 30-31 and 51-52 are rejected under 35 U.S.C. 103 as being unpatentable over modified Holley, in view of Anderson et al. 10,171,944
Regarding claim 30, modified Holley teaches the method of claim 27, but fails to teach wherein the providing the notification is indicative of a movement direction or target location for moving the external device relative to one or more components of the respiratory therapy system. Anderson discloses an analogous acoustical monitoring device that does teach wherein the providing the notification is indicative of a movement direction or target location for moving the external device relative to one or more components (Column 3 line 15 states “In the system and method, a mobile device (such as a smartphone) uses passive listening and a location service on a mobile device to determine whether a disconnected device (such as a washing machine) is emitting sounds. The cloud-based audio analysis system analyzes the sounds emitted by the disconnected device and determines the status of the disconnected device. Based on a predetermined event, the cloud-based audio analysis system issues a notification to the mobile device. “). 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 modified Holley with the teachings of Anderson and include a notification of the external device indicating movement towards a target device as this provides the user with a convenient method of monitoring operating status of a device based on received sound (abstract). Modified Holley with this concept of Anderson would now teach the notification being applied to components of the respiratory therapy system.
Regarding claim 31, modified Holley in view of Anderson teaches the method of claim 30. Anderson further teaches wherein the providing the notification includes presenting feedback associated with accuracy of the external device's movement along the movement direction (Column 5 line 13 states “At step 203, mobile device 110 determines whether mobile device 110 is in proximity to a predefined location of disconnected device 120. In response to determining that mobile device 110 is in proximity to the predefined location of disconnected device 120, at step 204, mobile device 110 invokes passive listening of mobile device 110 to a sound generated by disconnected device 120.”).
Regarding claim 51, modified Holley teaches the method of claim 50, but fails to teach wherein the confirming includes: instructing the user to move the external device to one or more specific locations to capture image data at the one or more specific locations; and analyzing the image data captured at the one or more specific locations to confirm the determination based on the acoustic data. Anderson does teach wherein the confirming includes: instructing the user to move the external device to one or more specific locations to capture image data at the one or more specific locations (Column 3 line 15 states “In the system and method, a mobile device (such as a smartphone) uses passive listening and a location service on a mobile device to determine whether a disconnected device (such as a washing machine) is emitting sounds. The cloud-based audio analysis system analyzes the sounds emitted by the disconnected device and determines the status of the disconnected device. Based on a predetermined event, the cloud-based audio analysis system issues a notification to the mobile device. “); and analyzing the image data captured at the one or more specific locations to confirm the determination based on the acoustic data (Column 5 line 13 states “At step 203, mobile device 110 determines whether mobile device 110 is in proximity to a predefined location of disconnected device 120. In response to determining that mobile device 110 is in proximity to the predefined location of disconnected device 120, at step 204, mobile device 110 invokes passive listening of mobile device 110 to a sound generated by disconnected device 120.”). 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 modified Holley with the teachings of Anderson and include instructing the user to move the external device to one or more specific locations to capture image data at the one or more specific locations; and analyzing the image data captured at the one or more specific locations to confirm the determination based on the acoustic data as this provides the user with a convenient method of monitoring operating status of a device based on received sound (abstract).
Regarding claim 52, modified Holley in view of Anderson teaches the method of claim 51, wherein the instructing includes: capturing real-time video data using the external device (Camera 14 of Thrushel is a video camera); and showing on a display of the external device an overlay of directional instructions, remarks, or both, to instruct the user to move the external device to the one or more specific locations (Column 5 line 13 of Anderson states “At step 203, mobile device 110 determines whether mobile device 110 is in proximity to a predefined location of disconnected device 120. In response to determining that mobile device 110 is in proximity to the predefined location of disconnected device 120, at step 204, mobile device 110 invokes passive listening of mobile device 110 to a sound generated by disconnected device 120.”).
Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over modified Holley, in view of Burgess et al. KR 20190010874
Regarding claim 53, modified Holley teaches the method of claim 1, but fails to teach further comprising causing a speed of a motor of the respiratory therapy system to ramp up as the acoustic data is generated, and wherein identifying the location of the operational issue, the cause of the operational issue, or both, includes analyzing the acoustic data generated at different speeds of the motor. Burgess teaches an analogous flow detection device for flow therapy devices that does teach further comprising causing a speed of a motor of the respiratory therapy system to ramp up as the acoustic data is generated, and wherein identifying the location of the operational issue (taught by modified Holley), the cause of the operational issue, or both, includes analyzing the acoustic data generated at different speeds of the motor (page 8 of the attached translated application states “The flow rate can be measured using a high-speed response-time flow sensor, such as an ultrasonic sensor assembly comprising first and second ultrasonic transducers”, “The first and second ultrasonic transducers can transmit and receive ultrasonic signals between each other. The controller of the breathing apparatus may determine one or more characteristics of the gas flow, including but not limited to flow rate, based on propagation time measurements between the first and second ultrasonic transducers. Further, the flow rate can be measured using one or more ultrasonic transmitters and one or more ultrasonic receivers, for example, using a microphone. One or more ultrasonic transmitters may transmit ultrasonic signals along the acoustic path. One or more ultrasound receivers may be positioned along the acoustic path to receive ultrasound signals. The controller of the breathing apparatus may determine one or more characteristics of the gas flow, including but not limited to flow rate, based on propagation time measurements between the one or more ultrasonic transmitters and the receiver.” The flow rate in this case can be based on the motor speed, therefore acoustic data based on different flow rates would be based on different motor speeds). 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 modified Holley with the teachings of Burgess and include further comprising causing a speed of a motor of the respiratory therapy system to ramp up as the acoustic data is generated, and wherein identifying the location of the operational issue, the cause of the operational issue, or both, includes analyzing the acoustic data generated at different speeds of the motor as this further refines the model in diagnosing and determining operational issues based on acoustic data.
Response to Arguments
Applicant’s arguments with respect to claims 1, 46, and 48 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ROHAN PATEL/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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