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 .
Response to Amendment
The amendment filed 11/20/2025 has been entered. Claims 1, 3-13, and 15-21 remain pending in the application.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 7-12, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US 20180092595 A1) in view of Coyle et al. (US 20070276278 A1), hereinafter Coyle, in view of Ljungberg (US 20190192046 A1) in further view of Adams (US 20150283337 A1).
Regarding claim 1, Chen discloses a method for measuring an inspiratory/expiratory air flow rate from an inhalation/exhalation (abstract: “measure events relating to inhalation and exhalation”) to a microphone of a personal computing device by a user ([0024]: “mobile device 101” and “a microphone 125”) the electronic device having a display ([0024]: “a display 140”) and an input device ([0029]: “user interface”), the method executable by a processor ([0024]) , the method comprising: obtaining a selected inhaler as selected by the user among a plurality thereof ([0037]: “patient can select the particular inhaler manually via the mobile device user-interface”), and prompting the user to perform an inhalation/exhalation in close proximity to the microphone of the personal computing device during a measurement period of time ([0047]; “the patient can be prompted to exhale”); measuring a sound signal during the inhalation/exhalation by the microphone and generating a sound data based on the sound signal during the inhalation/exhalation performed during the measurement period of time ([0051]); based on the sound data, determining, by the processor, an inspiratory/expiratory air flow rate by comparing the collected sound data with a flow rate data set ([0047]: “the processor can use the microphone to capture sound and verify from the captured sound data whether the volume and duration of the exhalation event meets the prescribed requirements”, [0057]) used by an industrially calibrated device and stored in an inhaler-appropriate flow-rate database ([0028], [0037]).
Chen fails to disclose a sound signal during the inhalation/exhalation comprising a peak inspiratory flow rate.
Coyle discloses a system of monitoring respiratory and sound data (abstract) including measuring by a microphone a sound signal ([0046]: “and one or more microphones for detecting cough sounds, such as throat microphone 14”) during the inhalation/exhalation comprising a peak inspiratory flow rate ([0107]: “thresholds may be specified that must be exceeded by the peak expiratory flow and the succeeding peak inspiratory flow.
As Chen discloses a peak-flow test ([0040]: “the patient can be prompted to take a peak-flow test using an electronic peak-flow meter”) but does not specify a peak inspiratory flow, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the method disclosed by Chen to include a peak inspiratory flow as disclosed by Coyle in order to obtain a more robust data set.
Chen as modified by Coyle fails to disclose a sound signal during the inhalation/exhalation comprising a peak inspiratory flow rate; determining, by the processor, if the inspiratory/expiratory air flow rate is within a predetermined range for the selected inhaler; determining whether the selected inhaler is one of the appropriate inhalers for the inspiratory/expiratory flow measured by comparing the determined inspiratory/expiratory air flow rate with a range of inspiratory/expiratory air flow rate corresponding to the selected inhaler; and based on determining that the selected inhaler is one of the appropriate inhalers, generating and displaying a conclusion message on the display of the personal computing device.
Ljungberg discloses determining, by the processor, if the inspiratory/expiratory air flow rate (Fig 3 element 54 or 56) is within a predetermined range for the selected inhaler ([0030], Fig 3 element 40 and 44, wherein the area under the curve 44 intersects with the area under the curve of both 54 and 56); determining whether the selected inhaler is one of the appropriate inhalers for the inspiratory/expiratory flow measured by comparing the determined inspiratory/expiratory air flow rate with a range of inspiratory/expiratory air flow rate corresponding to the selected inhaler ([0030]: “the most suitable inhaler for the specific user would be the inhaler that provides the largest dose emission below, within, the inhalation flow over time curve of the specific user”) and based on determining that the selected inhaler is one of the appropriate inhalers, generating and displaying a conclusion message on the display of the personal computing device ([0008]).
Chen discloses a method of determining whether or not a patient’s airflow is adequate based on the selected inhaler ([0057]) and providing feedback ([0057]:” generate a score for patient's performance of the particular step.”) to the patient. As the purpose of the method disclosed by Chen is to enhance patient understanding of the efficacy of their inhaler ([0005]), it would have been obvious to a person of ordinary skill in the art to further expand the system to provide additional feedback for a suitable inhaler type, as disclosed by Ljungberg, in order to increase the quantity of information provided to a patient about the effectiveness of their inhaler use (Ljungberg [0003-0005]).
Chen as modified by Ljungberg fails to disclose adjusting a microphone sensitivity to correlate with an inhaler resistance for the selected inhaler, and generating a sound data based on the sound signal during the inhalation/exhalation performed during the measurement period of time and based on the microphone sensitivity adjusted to correlate with the inhaler resistance for the selected inhaler.
Adams discloses an inhalation training device (title) wherein the patient’s airflow is measured via a microphone (abstract) and adjusting a microphone sensitivity ([0033]: “for adjusting the frequency range in which the microphone operates depending on the audio properties of the electronic device, in particular, its analog front-end sensitivity.”) to correlate with an inhaler resistance for the selected inhaler ([0092]: “but typically the flow signal is carried well within narrow bands, e.g., 500 Hz to 1000 Hz (dependent on the inhaler type among others). The preferred embodiment of the inhalation training device therefore allows for adjusting the frequency range in”), attenuating by the processor ([0080]), and generating a sound data based on the sound signal during the inhalation/exhalation performed during the measurement period of time ([0035]: “the inhalation training device comprises electronics configured to generate a reference tone during training”), the sound signal measured by the microphone based on the microphone sensitivity determined for the selected inhaler, the microphone sensitivity being correlated to the inhaler resistance for the selected inhaler ([0033], [0133]) and further based on the microphone sensitivity adjusted to correlate with the inhaler resistance for the selected inhaler ([0032-0033], [0169]: “of correct inhalation flow in the range of at least 20 to 40 l/min with an accuracy of at least +/−50% but preferably better than +/−20%.”).
It would have been obvious to a person of ordinary skill in the art to modify the method disclosed by Chen and Ljungberg with the method of attenuating a sound signal based on microphone sensitivity and inhaler resistance as disclosed by Adams in order to optimize detection of airflow based on inhaler type (Adams [0033]).
Regarding claim 7, Chen, Coyle, Adams, and Ljungberg disclose the method of claim 1. Ljungberg further discloses generating and displaying the conclusion message on the display of the personal computing device that the selected type of the inhaler is one of the appropriate types of the inhaler in response to determining that the selected type of the inhaler is one of the appropriate types of the inhaler ([0008-0009]).
Regarding claim 8, Chen, Coyle, Adams, and Ljungberg disclose the method of claim 1. Ljungberg further discloses the conclusion message is generated based on determining whether an inhaler identifier associated with the selected inhaler is within the range of inspiratory/expiratory air flow rate corresponding to the selected inhaler ([0016]).
Regarding claim 9 Chen, Coyle, Adams, and Ljungberg disclose the method of claim 1, and Chen further discloses wherein the range of inspiratory/ expiratory airflow rate corresponding to the selected inhaler is stored in a remote database located on a remote server ([0028]).
Regarding claim 10, Chen, Coyle, Adams, and Ljungberg disclose the method of claim 1. Chen further discloses wherein the selected inhaler comprises other inhalers being of the same type of the inhalers ([0037]: “include identification of the particular type of inhaler device that is used by the patient”).
Regarding claim 11, Chen, Coyle, Adams, and Ljungberg disclose the method of claim 1. Chen further discloses that the processor is the processor of the personal computing device ([0024]).
Regarding claim 12, Chen, Coyle, Adams, and Ljungberg disclose the method of claim 1. Chen further discloses obtaining the selected inhaler comprises prompting the user to select, using the input device, an inhaler among inhalers rendered on the display to indicate the selected inhaler ([0037]).
Regarding claim 21, Chen discloses a method for measuring an inspiratory/expiratory air flow rate from an inhalation/exhalation (abstract: “measure events relating to inhalation and exhalation”) to a microphone of a personal computing device by a user ([0024]: “mobile device 101” and “a microphone 125”) the electronic device having a display ([0024]: “a display 140”) and an input device ([0029]: “user interface”), the method executable by a processor ([0024]) , the method comprising: obtaining a selected inhaler as selected by the user among a plurality thereof ([0037]: “patient can select the particular inhaler manually via the mobile device user-interface”), and prompting the user to perform an inhalation/exhalation in close proximity to a microphone of the personal computing device during a measurement period of time ([0047]; “the patient can be prompted to exhale”); measuring a sound signal during the inhalation/exhalation by the microphone and generating a sound data based on the sound signal during the inhalation/exhalation performed during the measurement period of time ([0051]); based on the sound data, determining, by the processor, an inspiratory/expiratory air flow rate by comparing the collected sound data with a flow rate data set ([0047]: “the processor can use the microphone to capture sound and verify from the captured sound data whether the volume and duration of the exhalation event meets the prescribed requirements”, [0057]) used by the industrially calibrated device and stored in an inhaler-appropriate flow-rate database ([0028], [0037]).
Chen fails to disclose a sound signal during the inhalation/exhalation comprising a peak inspiratory flow rate.
Coyle discloses a system of monitoring respiratory and sound data (abstract) including measuring by a microphone a sound signal ([0046]: “and one or more microphones for detecting cough sounds, such as throat microphone 14”) during the inhalation/exhalation comprising a peak inspiratory flow rate ([0107]: “thresholds may be specified that must be exceeded by the peak expiratory flow and the succeeding peak inspiratory flow.”).
As Chen discloses a peak-flow test ([0040]: “the patient can be prompted to take a peak-flow test using an electronic peak-flow meter”) but does not specify a peak inspiratory flow, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the method disclosed by Chen to include a peak inspiratory flow as disclosed by Coyle in order to obtain a more robust data set.
Chen as modified by Coyle fails to disclose determining, by the processor, if the inspiratory/expiratory air flow rate is within a predetermined range for the selected inhaler; determining whether the selected inhaler is one of the appropriate inhalers for the inspiratory/expiratory flow measured by comparing the determined inspiratory/expiratory air flow rate with a range of inspiratory/expiratory air flow rate corresponding to the selected inhaler; and based on determining that the selected inhaler is one of the appropriate inhalers, generating and displaying a conclusion message on the display of the personal computing device.
Ljungberg discloses determining, by the processor, if the inspiratory/expiratory air flow rate (Fig 3 element 54 or 56) is within a predetermined range for the selected inhaler ([0030], Fig 3 element 40 and 44, wherein the area under the curve 44 intersects with the area under the curve of both 54 and 56); determining whether the selected inhaler is one of the appropriate inhalers for the inspiratory/expiratory flow measured by comparing the determined inspiratory/expiratory air flow rate with a range of inspiratory/expiratory air flow rate corresponding to the selected inhaler ([0030]: “the most suitable inhaler for the specific user would be the inhaler that provides the largest dose emission below, within, the inhalation flow over time curve of the specific user”) and based on determining that the selected inhaler is one of the appropriate inhalers, generating and displaying a conclusion message on the display of the personal computing device ([0008]).
Chen discloses a method of determining whether or not a patient’s airflow is adequate based on the selected inhaler ([0057]) and providing feedback ([0057]:” generate a score for patient's performance of the particular step.”) to the patient. As the purpose of the method disclosed by Chen is to enhance patient understanding of the efficacy of their inhaler ([0005]), it would have been obvious to a person of ordinary skill in the art to further expand the system to provide additional feedback for a suitable inhaler type, as disclosed by Ljungberg, in order to increase the quantity of information provided to a patient about the effectiveness of their inhaler use (Ljungberg [0003-0005]).
Adams discloses an inhalation training device (title) wherein the patient’s airflow is measured via a microphone (abstract) and adjusting a microphone sensitivity ([0033]: “for adjusting the frequency range in which the microphone operates depending on the audio properties of the electronic device, in particular, its analog front-end sensitivity.”) to correlate with an inhaler resistance for the selected inhaler ([0092]: “but typically the flow signal is carried well within narrow bands, e.g., 500 Hz to 1000 Hz (dependent on the inhaler type among others). The preferred embodiment of the inhalation training device therefore allows for adjusting the frequency range in”), attenuating by the processor ([0080]), and generating a sound data based on the sound signal during the inhalation/exhalation performed during the measurement period of time ([0035]: “the inhalation training device comprises electronics configured to generate a reference tone during training”), the sound signal measured by the microphone based on the microphone sensitivity determined for the selected inhaler, the microphone sensitivity being correlated to the inhaler resistance for the selected inhaler ([0033], [0133]) and further based on the microphone sensitivity adjusted to correlate with the inhaler resistance for the selected inhaler ([0032-0033], [0169]: “of correct inhalation flow in the range of at least 20 to 40 l/min with an accuracy of at least +/−50% but preferably better than +/−20%.”).
It would have been obvious to a person of ordinary skill in the art to modify the method disclosed by Chen and Ljungberg with the method of attenuating a sound signal based on microphone sensitivity and inhaler resistance as disclosed by Adams in order to optimize detection of airflow based on inhaler type (Adams [0033]).
Chen further discloses the range of inspiratory/ expiratory air flow rate corresponding to the selected inhaler is stored in a remote database located on a remote server (Chen [0028]).
Claims 3-5 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Coyle in view of Ljungberg in view of Adams in further view of Darket (US 20160007913 A1).
Regarding claim 3, Chen, Coyle, Ljungberg, and Adams disclose the method of claim 1. Chen further discloses a database ([0025]). However, Chen and Ljungberg as modified by Adams fails to disclose that the microphone sensitivity is determined by retrieving, from a microphone sensitivity database, a value of the microphone sensitivity associated with an inhaler identifier associated with the selected inhaler.
Darket discloses a method wherein a spirometer’s resistance ([0075]) is determined by retrieving, from a spirometer resistance database, a value of the resistance associated with the inhaler identifier associated with the selected inhaler ([0075]:” Resistance values for specific devices and medicaments are usually published by the inhaler manufacturers”).
Darket discloses a method wherein a parameter of a measurement device to record inhalation/exhalation is adjusted to match the characteristics associated with a selected inhaler, thus modifying the measured airflow.
Adams further discloses that the parameter that is modified to match an inhaler can be the microphone sensitivity (Adams [0032 – 0033]).
As Chen already discloses means for storing inhaler data ([0028], [0037]: ”identification of the particular type of inhaler device”), it would have been obvious to a person of ordinary skill in the art to modify the database disclosed by Chen to include microphone sensitivities as modified by Adams and the step of retrieving a sensitivity from a database associated with an inhaler as disclosed by Darket in order to allow for a single device to mimic the features of multiple inhalers (Darket [0075]).
Regarding claim 4, Chen, Ljungberg, Adams, and Darket disclose the method of claim 3. Chen further discloses the microphone sensitivity database is located locally on the electronic device ([0025]).
Regarding claim 5, Chen, Ljungberg, Adams, and Darket disclose the method of claim 3. Chen further discloses the microphone sensitivity database is located remotely on the remote server ([0028]).
Regarding claim 13, Chen discloses a system for measuring an air flow rate from an inhalation (abstract), the system comprising: a display ([0024]) and an input device ([0029]) and a microphone of a personal computing device ([0024]) configured to measure a sound signal during the inhalation/exhalation ([0051]), a local processor ([0024]) coupled to a remote processor ([0026]: “the remote systems can be connected to mobile device”), both configured to: receive a selection of an inhaler among inhalers rendered on the display to indicate a selected inhaler ([0037]), and prompt the user to perform an inhalation/exhalation in close proximity to the microphone of the personal computing device during a measurement period of time ([0047]); generate, by the local processor, a sound data based on the sound signal during the inhalation/exhalation performed during the measurement period of time ([0047]); based on the sound data, and determine an inspiratory/expiratory airflow rate ([0056]) by comparing the sound data with a flow rate data set used by the industrially calibrated device and stored in a calibration database ([0057]).
Chen fails to disclose a sound signal during the inhalation/exhalation comprising a peak inspiratory flow rate.
Coyle discloses a system of monitoring respiratory and sound data (abstract) including measuring by a microphone a sound signal ([0046]: “and one or more microphones for detecting cough sounds, such as throat microphone 14”) during the inhalation/exhalation comprising a peak inspiratory flow rate ([0107]: “thresholds may be specified that must be exceeded by the peak expiratory flow and the succeeding peak inspiratory flow.
As Chen discloses a peak-flow test ([0040]: “the patient can be prompted to take a peak-flow test using an electronic peak-flow meter”) but does not specify a peak inspiratory flow, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the method disclosed by Chen to include a peak inspiratory flow as disclosed by Coyle in order to obtain a more robust data set.
Chen as modified by Coyle fails to disclose a sound signal during the inhalation/exhalation comprising a peak inspiratory flow rate; determining, by the processor, if the inspiratory/expiratory air flow rate is within a predetermined range for the selected inhaler; determining whether the selected inhaler is one of the appropriate inhalers for the inspiratory/expiratory flow measured by comparing the determined inspiratory/expiratory air flow rate with a range of inspiratory/expiratory air flow rate corresponding to the selected inhaler; and based on determining that the selected inhaler is one of the appropriate inhalers, generating and displaying a conclusion message on the display of the personal computing device.
Ljungberg discloses a method of selecting a suitable inhaler based on inspiration/expiration (abstract) including determining if the inspiratory/expiratory air flow rate (Fig 3 element 54 or 56) is within a predetermined range for the selected inhaler ([0030], Fig 3 element 40 and 44, wherein the area under the curve 44 intersects with the area under the curve of both 54 and 56); determine whether the selected inhaler is one of the appropriate inhalers for the inspiratory/expiratory flow measured by comparing the inspiratory flow (Figure 3 element 54 or 56, [0030]) with a range of inspiratory/expiratory flow corresponding to the selected inhaler (Figure 3 element 40, [0030]); and based on determining that the selected inhaler is one of the appropriate inhalers, generate a conclusion message on the display of the personal computing device ([0008]). Ljungberg additionally discloses and an inhaler-appropriate flow-rate database comprising predetermined ranges for inhalers and inhaler identifiers ([0052]).
Chen discloses a method of determining whether or not a patient’s airflow is adequate based on the selected inhaler ([0057]) and providing feedback ([0057]:” generate a score for patient's performance of the particular step.”) to the patient. As the purpose of the method disclosed by Chen is to enhance patient understanding of the efficacy of their inhaler ([0005]), it would have been obvious to a person of ordinary skill in the art to further expand the system to provide additional feedback for a suitable inhaler type, as disclosed by Ljungberg, in order to increase the quantity of information provided to a patient about the effectiveness of their inhaler use (Ljungberg [0003-0005]).
Additionally, Chen discloses a database ([0028]) capable of storing inhaler information ([0037]). As Chen is already capable of storing predetermined information associated with an inhaler, it would have been obvious to modify the database disclosed by Chen with the inhaler data disclosed by Ljungberg to account for inhaler types with different dosage emissions ([0004]).
Chen as modified by Ljungberg fails to disclose a microphone sensitivity database comprising a plurality of pairs of microphone sensitivity values and inhaler identifiers.
Darket discloses a method wherein a spirometer’s resistance ([0075]) is determined by retrieving, from a spirometer resistance database, a value of the resistance associated with the inhaler identifier associated with the selected inhaler ([0075]:” Resistance values for specific devices and medicaments are usually published by the inhaler manufacturers”).
Darket discloses a method wherein a parameter of a measurement device to record inhalation/exhalation is adjusted to match the characteristics associated with a selected inhaler, thus modifying the measured airflow ([0075]).
Adams discloses an inhalation training device (title) wherein the patient’s airflow is measured via a microphone (abstract) and adjusting a microphone sensitivity ([0033]: “for adjusting the frequency range in which the microphone operates depending on the audio properties of the electronic device, in particular, its analog front-end sensitivity.”) to correlate with an inhaler resistance for the selected inhaler ([0092]: “but typically the flow signal is carried well within narrow bands, e.g., 500 Hz to 1000 Hz (dependent on the inhaler type among others). The preferred embodiment of the inhalation training device therefore allows for adjusting the frequency range in”), attenuating by the processor ([0080]), and generating a sound data based on the sound signal during the inhalation/exhalation performed during the measurement period of time ([0035]: “the inhalation training device comprises electronics configured to generate a reference tone during training”), the sound signal measured by the microphone based on the microphone sensitivity determined for the selected inhaler, the microphone sensitivity being correlated to the inhaler resistance for the selected inhaler ([0033], [0133]) and further based on the microphone sensitivity adjusted to correlate with the inhaler resistance for the selected inhaler ([0032-0033], [0169]: “of correct inhalation flow in the range of at least 20 to 40 l/min with an accuracy of at least +/−50% but preferably better than +/−20%.”).
As Chen already discloses means for storing inhaler data ([0028], [0037]:” identification of the particular type of inhaler device”), it would have been obvious to a person of ordinary skill in the art to modify the database disclosed by Chen to include microphone sensitivities disclosed by Darket and Adams in order to allow for a single device to mimic the features of multiple inhalers (Darket [0075]).
Regarding claim 14, Chen, Coyle, Ljungberg, Adams, and Darket disclose the system of claim 13. Adams further discloses the sound data being generated comprises the sound signal attenuated based on the microphone sensitivity determined for the selected inhaler ([0052-0053]).
Regarding claim 15, Chen, Coyle, Ljungberg, Adams, and Darket disclose the system of claim 13. Darket, as modified by Adams, further discloses the microphone sensitivity is determined by retrieving, from a microphone sensitivity database, a value of the microphone sensitivity associated with the inhaler identifier associated with the selected inhaler ([0075])).
Regarding claim 16, Chen, Coyle, Ljungberg, Adams, and Darket disclose the system of claim 15. Chen further discloses the microphone sensitivity database is located locally on the electronic device ([0025]).
Regarding claim 17, Chen, Coyle, Ljungberg, Adams, and Darket disclose the system of claim 15. Chen further discloses the microphone sensitivity database is located remotely on the remote server ([0028]).
Regarding claim 18, Chen, Coyle, Ljungberg, Adams, and Darket disclose the method of claim 13. Adams further discloses adjusting the microphone sensitivity prior to measuring the sound data ([0033]).
Regarding claim 19, Chen, Coyle, Ljungberg, Adams, and Darket disclose the method of claim 13. Ljungberg further discloses the conclusion message is generated based on determining whether an inhaler identifier associated with the selected inhaler is within the range of inspiratory/expiratory flow corresponding to the selected inhaler ([0016]).
Regarding claim 20, Chen, Coyle, Ljungberg, Adams, and Darket disclose the method of claim 13. Chen further discloses obtaining the selected inhaler comprises prompting the user to select, using the input device, an inhaler among inhalers rendered on the display to indicate the selected inhaler ([0037]).
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive.
Applicant argues on pages 9-11 of the Remarks that Adams does not teach the limitation “adjusting a microphone sensitivity to correlate with an inhaler resistance for the selected inhaler” as amended in claims 1, 13, and 21. First, applicant argues that Adams teaches an adjustment for the frequency range of the microphone as opposed to a sensitivity. However, as cited in para [0092], the adjustment of the frequency is based on the sensitivity. Applicant further argues the adjustment is not based on an inhaler resistance but instead on the characteristics of the electronic device itself. However, Adams states that the adjustment of the microphone properties is dependent on a property of the inhaler ([0092]). The limitation imposed by the electronic device might reduce the range to which the microphone can be adjusted, but it does not prevent the initial adjustment. Applicant argues further, “in Adams, the training device has a resistance matched to a stand-alone inhaler (Adams at paragraphs [0133] and [0169]). Thus, there would be no need to consider variations in inhaler resistance or to make corresponding adjustments to microphone sensitivity.” As Adams teaches adjusting a microphone an inhaler type and Ljungberg and Chen teaches selecting a variety of inhaler types, there exists a motivation for adjusting a microphone to a selected inhaler type.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Matthewson et al. (US 20220031973 A1) – discloses adjustment of a microphone based on sensitivity
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791