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 .
Information Disclosure Statement
The information disclosure statement filed 8/22/2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because Non-Patent Literature Documents reference number 7 lacks a proper date. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Objections
Claim 7 is objected to because of the following informalities: claim 7 recites an extraneous space for line 4, which is suggested to be deleted in order to be grammatically correct.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitations "the duration" in lines 9-10, “the number” in line 10, “the oscillation frequency” in line 12, and “the exhalations” in line 12. There is insufficient antecedent basis for these limitations in the claim.
Claim 4 recites the limitation "the session time" in line 3. There is insufficient antecedent basis for this limitation in the claim. Moreover, the limitation “the oscillation frequency” in line 3 is confusing, as it is unclear whether “the oscillation frequency of the exhalations” or “a target exhalation frequency” of claim 1 is being referenced. Furthermore, the term “best” in line 4 is a relative term which renders the claim indefinite. The term “best” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, the parameter of therapeutic effect achieved is rendered indefinite.
Regarding claim 5, the limitations “a microphone” in line 3 and “a processor” in line 4 are confusing, as it is unclear whether these are meant to reference “a microphone” and “a processing and memory unit” of claim 1, respectively. For the purposes of examination, they will be interpreted as the same respective limitations.
Regarding claim 6, the limitation “can be” in line 3 is confusing, as it is unclear whether the following claim limitations are required or not for the claimed invention.
Claim 7 recites the limitations "the frequency of operation" in line 2, “the resistance” in line 2, and “the measured oscillation frequency” in line 8. There is insufficient antecedent basis for these limitations in the claim. Moreover, the term “maximize” in line 3 is a relative term which renders the claim indefinite. The term “maximize” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, the amount of benefit to the user is rendered indefinite.
Claim 9 recites the limitations "the duration" in line 11, “the number” in lines 11-12, “the oscillation frequency” in line 13, and “the exhalations” in line 13. There is insufficient antecedent basis for these limitations in the claim.
Regarding claim 14, the limitation “can be” in line 3 is confusing, as it is unclear whether the following claim limitations are required or not for the claimed invention.
Claim 15 recites the limitations "the frequency of operation" in line 2 and “the resistance” in line 2. There is insufficient antecedent basis for these limitations in the claim.
Any remaining claims are rejected based on their dependency on a rejected base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4-9, and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Pelerossi et al. (US 2006/0090753 A1) in view of Sather et al. (US 2011/0290256 A1), Gonnen et al. (US 2013/0190641 A1), and Baumert et al. (US 2007/0089740 A1).
Regarding claim 1, as best understood, Pelerossi discloses a method of evaluating use of a respiratory therapy device having a valve opened and closed by breathing of a user through the respiratory therapy device to cause a rocker arm in the respiratory therapy device to effect an oscillating movement that produces a sound (closure member 447 on rocker arm 445 which is periodically inserted into outlet 487 to create the oscillatory PEP as expiratory air is passed from the patient; the oscillatory PEP device functions by generating positive expiratory pressure waves through the air to administer to the exhaling patient; according to The Free Dictionary, sound is defined as “transmitted vibrations of any frequency”, thus, as the positive expiratory pressure waves generated by the rocker arm oscillation propagate through the air with a frequency and magnitude, they are sound waves; the PEP treatment or therapy is applied in accordance with the desires of the healthcare provider, and so the treatment would be evaluated by the healthcare provider) (Figs. 1-15; para. [0022]; para. [0030]; para. [0036]).
Pelerossi does not disclose producing an audible sound; placing a sensor unit including a microphone connected to a processing and memory unit close to the respiratory therapy device to pick up the audible sound from the respiratory therapy device when the user begins a therapy session by breathing though the respiratory therapy device; processing the audible sound to measure parameters including at least the duration of exhalation and the number of exhalations by the user during the therapy session; calculating at least the oscillation frequency of the exhalations by the user during the therapy session; presenting the user a feedback as to whether the user has achieved a target oscillation frequency.
However, Sather teaches a respiratory device with an airflow resistor (Sather; abstract) wherein the opening and closing of a valve creates an audible sound (movement/closure of the valve creates noise) (Sather; para. [0149]), placing a sensor unit including a microphone connected to a processing and memory unit close to the respiratory therapy device to pick up the audible sound from the respiratory therapy device when the user begins a therapy session by breathing though the respiratory therapy device (the noise created can be detected by a sound detector/sensor such as a microphone as part of a monitoring device used to monitor respiration; monitoring device can store and transmit data when analyzing the device for patient compliance with a treatment) (Sather; para. [0016]; para. [0044]; para. [0149]). Moreover, Gonnen teaches a system for monitoring spirometric flow (Gonnen; abstract) including a microphone responsive to sound (microphone 12 detects audible signal 24 from acoustic transducer 20, which senses information about airflow) (Gonnen; Fig. 1a; para. [0037]; para. [0046]), placing a sensor unit including a microphone connected to a processing and memory unit close to the respiratory therapy device to pick up the audible sound from the respiratory therapy device when the user breathes though the respiratory therapy device (microphone 12 in a smartphone, the smartphone having a processor 14 and working memory 25, is separate from and close to the acoustic transducer device 20a that detects an audible signal 24 responsive to the user’s spirometric flow through the acoustic transducer device 20a) (Gonnen; Figs. 1a, 2c-2d; para. [0037]; para. [0046]; para. [0062]); processing the audible sound (user inhales and exhales, which causes air to flow through the transducer 20 which sends an audible signal to be picked up by the microphone for processing and displaying) (Gonnen; Fig. 4; para. [0038]; para. [0062]); calculating at least the oscillation frequency of the exhalations by the user (acoustic transducer can have an oscillator that creates vibrations at a frequency determined by the microphone 12 that is a function of expiratory pressure or flow rate) (Gonnen; para. [0033]; claim 5; claim 9). Furthermore, Baumert teaches a PEP device (Baumert; para. [0002]) including a sensor responsive to the airflow (sensors signaling information about airflow) (Baumert; para. [0012]; para. [0028]; para. [0041]), processing to measure parameters including at least the duration of exhalation and the number of exhalations by the user during the therapy session (with a PEP device, therapy is provided to a user during the exhaling phase of a breathing cycle; thus, when processing data to determine parameters such as the duration of a breath or number of breaths, these breaths would be exhalations) (Baumert; para. [0026]; para. [0040]); presenting the user a feedback as to whether the user has achieved a target parameter (controller 24 with indicator 26 provides the user with information and feedback on the breathing therapy, so a user can assess the progress or success of the breathing exercises and therapy with regards to breathing parameters such as durations or number of breaths) (Baumert; para. [0006]; paras. [0040-0043]). Thus, the combination of these three references essentially teaches a PEP device can include a sensor responsive to the airflow (Baumert; para. [0012]; para. [0028]; para. [0041]), with the specific type of sensor being a microphone separate from the PEP device which detects audible sounds from the opening and closing of a valve as the airflow information (Sather, para. [0149]; Gonnen, Fig. 1a, para. [0037], para. [0046]), and a processing and memory unit for processing the signal received by the sensor, in this case the microphone connected to the processing and memory unit (Gonnen; Figs. 1a, 2d; para. [0009]; para. [0037]; para. [0046]; para. [0054]), so as to provide a feedback to the patient (Baumert; para. [0040]; paras. [0042-0043]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Pelerossi method to produce an audible sound, as taught by Sather, for the purpose of enabling the opening and closing activity of the valve to be detected and monitored by a microphone (Sather; para. [0149]). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Pelerossi method to include placing a sensor unit including a microphone connected to a processing and memory unit as claimed, as taught by Baumert and Gonnen, for the purpose of providing a user with feedback so a user can assess the progress of the breathing exercises and therapy (Baumert; para. [0040]), as well as to enable the patient air flow information to be monitored and stored by a mobile computer device, thus enabling the air flow information to be efficiently provided to a medical practitioner so that a higher quality healthcare serve can be provided (Gonnen; paras. [0006-0009]).
With these modifications, the modified Pelerossi device would thus teach producing an audible sound (noise from valve activity) (Sather; para. [0149]); placing a sensor unit including a microphone connected to a processing and memory unit close to the respiratory therapy device to pick up the audible sound from the respiratory therapy device when the user begins a therapy session by breathing though the respiratory therapy device (Gonnen microphone 12 in a smartphone, the smartphone having a processor 14 and working memory 25, is separate from and close to the Gonnen acoustic transducer device 20a that detects an audible signal 24 responsive to the user’s spirometric flow through the Gonnen acoustic transducer device 20a, and so would detect the audible noise from the Pelerossi closure member 447, as modified by Sather, when the patient begins the Pelerossi PEP treatment by exhaling through the Pelerossi PEP respiratory therapy device 1000) (Pelerossi, Figs. 1-15, para. [0022], para. [0030]; Sather, para. [0149]; Gonnen, Figs. 1a and 2c-2d, para. [0037], para. [0046], para. [0062]); processing the audible sound to measure parameters (user exhales, which causes air to flow through the transducer 20 which sends an audible signal to be picked up by the microphone, the signal then being processed to determine spirometric flow rate) (Gonnen; Fig. 4; para. [0038]; para. [0062]) including at least the duration of exhalation and the number of exhalations by the user during the therapy session (with a PEP device, therapy is provided to a user during the exhaling phase of a breathing cycle; thus, when processing data to determine parameters such as the duration of a breath or number of breaths, these breaths would be exhalations) (Baumert; para. [0026]; para. [0040]); calculating at least the oscillation frequency of the exhalations by the user during the therapy session (acoustic transducer can have an oscillator that creates vibrations at a frequency determined by the microphone 12 that is a function of expiratory pressure or flow rate) (Gonnen; para. [0033]; claim 5; claim 9); presenting the user a feedback as to whether the user has achieved a target oscillation frequency (Baumert controller 24 with indicator 26 provides the user with information and feedback on the breathing therapy, so a user can assess the progress or success of the breathing exercises and therapy with regards to breathing parameters such as Gonnen oscillation frequency) (Gonnen, para. [0033], claim 5, claim 9; Baumert, para. [0006], paras. [0040-0043]).
Regarding claim 4, as best understood, the modified Pelerossi teaches providing a display at the sensor unit to present the user with at least a representation of the session time and the oscillation frequency to enable the user to achieve best therapeutic effect (microphone 12 is a part of a mobile computer device 1, which can be a smartphone; smartphone has a display 17 to output data responsive to the received frequency, which can be vibrations from an oscillator at an optimal frequency for typical flow rates, or user selectable parameters such as spirometric measurements over a time period) (Gonnen; Figs. 1a, 2d; para. [0014]; para. [0027]; para. [0033]; para. [0037]; para. [0046]; para. [0068]).
Regarding claim 5, as best understood, the modified Pelerossi teaches effecting a mobile phone as the sensor unit by providing a program application for enabling a microphone in the mobile phone to pick up the audible sound from the respiratory therapy unit and a processor in the mobile phone to process the audible sound (microphone 12 within device 1 as a smartphone, and so would have a program application in order to use the microphone 12; microphone 12 detects audible signal 24 from acoustic transducer 20, which then is processed by processor 14 in the smartphone device 1) (Gonnen; Figs. 1a, 2d; para. [0027]; paras. [0037-0038]; para. [0046]).
Regarding claim 6, as best understood, the modified Pelerossi teaches providing an input means and a data interface including a wireless interface to the sensor unit such that information can be entered into the sensor unit by the input means or via the data interface from a remote computer (mobile computer device 1 can be a smart phone, and so would have a user interface with which a user can interact to enter data upon initialization; mobile computer device 1 is bi-directionally connectible to wide area network 100 to server 102 or client 104, and data can be exchanged between them wirelessly) (Gonnen; Figs. 1a-1b, 2d; para. [0027]; para. [0029]; para. [0040]; para. [0063]).
Regarding claim 7, as best understood, the modified Pelerossi teaches enabling the user to adjust the frequency of operation and the resistance to flow of air through the respiratory therapy device to maximize benefit for the user (user can rotate a frequency control dial 350 to control the frequency of the oscillations by which PEP treatment is applied to establish the healthcare provider’s desired level for treatment; the adjusting dial 350 adjusts frequency by changing the rate at which the outlet 487 is closed and re-opened, thereby changing resistance) (Pelerossi; Figs. 1, 3-6, 9-12; para. [0030]; para. [0036-0037]); entering the frequency of operation of the respiratory therapy device adjusted by the user into the sensor unit (in Gonnen, the system 10, which includes mobile computer device 1, records the characteristic frequency of acoustic device 20, which can be characteristic of a peak expiratory flow rate of the user; this Gonnen characteristic frequency would also change after the Pelerossi adjustment of oscillation frequency with the dial 350) (Pelerossi, Figs. 1, 3-6, and 9-12, para. [0030], para. [0036-0037]; Gonnen, Fig. 1a, para. [0064], claim 5); arranging the sensor unit to compute a measure of flow rate and pressure generated from the measured oscillation frequency and from the frequency of operation entered into the sensor unit (mobile computer device 1 has software to calculate flow rate from the measured frequency when a particular frequency is detected or when a characteristic frequency is not detected, and from there additional respiratory parameters can be calculated; the vibrations at a frequency are a function of pressure or flow rate, and so both could be calculated) (Gonnen; para. [0033]; para. [0057]; para. [0065]).
Regarding claim 8, the modified Pelerossi teaches mounting the sensor unit to the respiratory therapy device (smartphone device 1 with microphone 12 can be docked to the acoustic transducer device 20a via male docking port 510a and female docking port 510b) (Gonnen; Figs. 1a, 2c-2e; para. [0046]).
Regarding claim 9, as best understood, Pelerossi discloses a method of evaluating use of a respiratory therapy device having a valve opened and closed by breathing of a user through the respiratory therapy device to cause a rocker arm in the respiratory therapy device to effect an oscillating movement that produces a sound (closure member 447 on rocker arm 445 which is periodically inserted into outlet 487 to create the oscillatory PEP as expiratory air is passed from the patient; the oscillatory PEP device functions by generating positive expiratory pressure waves through the air to administer to the exhaling patient; according to The Free Dictionary, sound is defined as “transmitted vibrations of any frequency”, thus, as the positive expiratory pressure waves generated by the rocker arm oscillation propagate through the air with a frequency and magnitude, they are sound waves; the PEP treatment or therapy is applied in accordance with the desires of the healthcare provider, and so the treatment would be evaluated by the healthcare provider) (Figs. 1-15; para. [0022]; para. [0030]; para. [0036]).
Pelerossi does not disclose producing an audible sound; placing a sensor unit including a microphone adapted to pick up the audible sound close to the respiratory therapy device, the senor unit including a processing unit connected to the microphone; turning the sensor unit on to pick up the audible sound as the user starts a therapy session breathing through the respiratory therapy device; presenting a target oscillation frequency to the user during the therapy session; utilizing the processing unit to measure at least the duration of exhalation and the number of exhalations by the user from the audible sound picked up by the microphone, and to calculate the oscillation frequency of the exhalations by the user during the therapy session.
However, Sather teaches a respiratory device with an airflow resistor (Sather; abstract) wherein the opening and closing of a valve creates an audible sound (movement/closure of the valve creates noise) (Sather; para. [0149]), placing a sensor unit including a microphone adapted to pick up the audible sound close to the respiratory therapy device, the senor unit including a processing unit connected to the microphone (the noise created can be detected by a sound detector/sensor such as a microphone as part of a monitoring device used to monitor respiration; monitoring device can store and transmit data when analyzing the device for patient compliance with a treatment) (Sather; para. [0016]; para. [0044]; para. [0149]). Moreover, Gonnen teaches a system for monitoring spirometric flow (Gonnen; abstract) including a microphone responsive to sound (microphone 12 detects audible signal 24 from acoustic transducer 20, which senses information about airflow) (Gonnen; Fig. 1a; para. [0037]; para. [0046]), placing a sensor unit including a microphone adapted to pick up the audible sound close to the respiratory therapy device, the senor unit including a processing unit connected to the microphone (microphone 12 in a smartphone, the smartphone having a processor 14 and working memory 25, is separate from and close to the acoustic transducer device 20a that detects an audible signal 24 responsive to the user’s spirometric flow through the acoustic transducer device 20a) (Gonnen; Figs. 1a, 2c-2d; para. [0037]; para. [0046]; para. [0062]); turning the sensor unit on to pick up the audible sound as the user starts a therapy session breathing through the respiratory therapy device (microphone 12 would have to be on in order to function to detect the audible signal 24 responsive to the user’s spirometric flow through the acoustic transducer device 20a) (Gonnen; Figs. 1a, 2c-2d; para. [0037]; para. [0046]; para. [0062]); presenting a target oscillation frequency to the user during the therapy session (practitioner can provide target respiration values upon initialization of the system 10; respiration values can include the oscillator vibrations as a function of pressure or flow rate) (Gonnen; para. [0033]; para. [0063]); and to calculate the oscillation frequency of the exhalations by the user during the therapy session (acoustic transducer can have an oscillator that creates vibrations at a frequency determined by the microphone 12 that is a function of expiratory pressure or flow rate) (Gonnen; para. [0033]; claim 5; claim 9). Furthermore, Baumert teaches a PEP device (Baumert; para. [0002]) including a sensor responsive to the airflow (sensors signaling information about airflow) (Baumert; para. [0012]; para. [0028]; para. [0041]), and utilizing the processing unit to measure at least the duration of exhalation and the number of exhalations by the user (with a PEP device, therapy is provided to a user during the exhaling phase of a breathing cycle; thus, when processing data to determine parameters such as the duration of a breath or number of breaths, these breaths would be exhalations) (Baumert; para. [0026]; para. [0040]). Thus, the combination of these three references essentially teaches a PEP device can include a sensor responsive to the airflow (Baumert; para. [0012]; para. [0028]; para. [0041]), with the specific type of sensor being a microphone separate from the PEP device which detects audible sounds from the opening and closing of a valve as the airflow information (Sather, para. [0149]; Gonnen, Fig. 1a, para. [0037], para. [0046]), and a processing and memory unit for processing the signal received by the sensor, in this case the microphone connected to the processing and memory unit (Gonnen; Figs. 1a, 2d; para. [0009]; para. [0037]; para. [0046]; para. [0054]), so as to provide a feedback to the patient (Baumert; para. [0040]; paras. [0042-0043]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Pelerossi method to produce an audible sound, as taught by Sather, for the purpose of enabling the opening and closing activity of the valve to be detected and monitored by a microphone (Sather; para. [0149]). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Pelerossi method to include placing a sensor unit including a microphone as claimed, as taught by Baumert and Gonnen, for the purpose of providing a user with feedback so a user can assess the progress of the breathing exercises and therapy (Baumert; para. [0040]), as well as to enable the patient air flow information to be monitored and stored by a mobile computer device, thus enabling the air flow information to be efficiently provided to a medical practitioner so that a higher quality healthcare serve can be provided (Gonnen; paras. [0006-0009]).
With these modifications, the modified Pelerossi device would thus teach producing an audible sound (noise from valve activity) (Sather; para. [0149]); placing a sensor unit including a microphone adapted to pick up the audible sound close to the respiratory therapy device, the senor unit including a processing unit connected to the microphone; turning the sensor unit on to pick up the audible sound as the user starts a therapy session breathing through the respiratory therapy device (Gonnen microphone 12 in a smartphone, the smartphone having a processor 14 and working memory 25, is separate from and close to the Gonnen acoustic transducer device 20a that detects an audible signal 24 responsive to the user’s spirometric flow through the Gonnen acoustic transducer device 20a, and so would detect the audible noise from the Pelerossi closure member 447, as modified by Sather, when the patient begins the Pelerossi PEP treatment by exhaling through the Pelerossi PEP respiratory therapy device 1000; the Gonnen microphone 12 would have to be on in order thus function) (Pelerossi, Figs. 1-15, para. [0022], para. [0030]; Sather, para. [0149]; Gonnen, Figs. 1a and 2c-2d, para. [0037], para. [0046], para. [0062]); presenting a target oscillation frequency to the user during the therapy session (Baumert controller 24 with indicator 26 provides the user with information and feedback on the breathing therapy, so a user can assess the progress or success of the breathing exercises and therapy with regards to breathing parameters such as Gonnen oscillation frequency) (Gonnen, para. [0033], claim 5, claim 9; Baumert, para. [0006], paras. [0040-0043]); utilizing the processing unit to measure at least the duration of exhalation and the number of exhalations by the user from the audible sound picked up by the microphone (user exhales, which causes air to flow through the Gonnen transducer 20 which sends an audible signal to be picked up by the Gonnen microphone, the signal then being processed to determine parameters such as spirometric flow rate; with a PEP device, therapy is provided to a user during the exhaling phase of a breathing cycle; thus, when processing the data to determine parameters such as the duration of a breath or number of breaths, these breaths would be exhalations) (Gonnen, Fig. 4, para. [0038], para. [0062]; Baumert, para. [0026], para. [0040]), and to calculate the oscillation frequency of the exhalations by the user during the therapy session (acoustic transducer can have an oscillator that creates vibrations at a frequency determined by the microphone 12 that is a function of expiratory pressure or flow rate during use) (Gonnen; para. [0033]; claim 5; claim 9).
Regarding claim 12, the modified Pelerossi teaches providing a display at the sensor unit to present the user with a representation of the session time and the oscillation frequency as the user breathes through the respiratory therapy device (microphone 12 is a part of a mobile computer device 1, which can be a smartphone; smartphone has a display 17 to output data responsive to the received frequency, which can be vibrations from an oscillator in acoustic transducer 20 through which the patient breathes, or user selectable parameters such as spirometric measurements over a time period) (Gonnen; Figs. 1a, 2d; para. [0014]; para. [0027]; para. [0033]; para. [0037]; para. [0046]; para. [0068]); presenting the target oscillation frequency on the display (Baumert controller 24 indicates to the use information and feedback on the breathing therapy, so a user can assess the progress or success of the breathing exercises and therapy with regards to breathing parameters such as Gonnen oscillation frequency; Gonnen display 17 outputs such data) (Gonnen, para. [0033], para. [0062], claim 5, claim 9; Baumert, para. [0006], paras. [0040-0043]).
Regarding claim 13, the modified Pelerossi teaches providing a program application to a mobile phone to enable the mobile phone to act as the sensor unit (mobile computer device 1, which can be a smart phone, has software to use the microphone 12 to pick up the audible sounds) (Gonnen; Figs. 1a, 2c-2d; para. [0027]; para. [0037]).
Regarding claim 14, as best understood, the modified Pelerossi teaches providing an input means and a data interface including a wireless interface to the sensor unit such that information can be entered into the sensor unit by the input means or via the data interface from a remote computer (mobile computer device 1 can be a smart phone, and so would have a user interface with which a user can interact to enter data upon initialization; mobile computer device 1 is bi-directionally connectible to wide area network 100 to server 102 or client 104, and data can be exchanged between them wirelessly) (Gonnen; Figs. 1a-1b, 2d; para. [0027]; para. [0029]; para. [0040]; para. [0063]).
Regarding claim 15, as best understood, the modified Pelerossi teaches providing an adjustment means at the respiratory therapy device to enable the user to adjust the frequency of operation and the resistance to flow of air through the respiratory therapy device for the therapy session (user can rotate a frequency control dial 350 to control the frequency of the oscillations by which PEP treatment is applied to establish the healthcare provider’s desired level for treatment; the adjusting dial 350 adjusts frequency by changing the rate at which the outlet 487 is closed and re-opened, thereby changing resistance) (Pelerossi; Figs. 1, 3-6, 9-12; para. [0030]; para. [0036-0037]).
Claims 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Pelerossi in view of Sather, Gonnen, and Baumert as applied to claims 1 and 9 above, and further in view of Begun et al. (US 5,474,090).
Regarding claim 2, the modified Pelerossi teaches the invention as previously claimed, including turning on the sensor unit when the user starts the therapy session (microphone 12 would have to be on in order to function to detect the audible signal 24 responsive to the user’s spirometric flow through the acoustic transducer device 20a) (Gonnen; Figs. 1a, 2c-2d; para. [0037]; para. [0046]; para. [0062]), but does not teach identifying the user by means of a profile of the user stored in a memory of the processing and memory unit when the user begins the therapy session.
However, Gonnen further teaches that when the processing unit is turned on, the processing unit provides information (Gonnen processor 14 with working memory 25 processes the signals, and the results can be displayed; the processor and display would have to be turned on in order to display that information) (Gonnen; Fig. 4; para. [0038]; para. [0062]). Furthermore, Begun teaches an apparatus and method for monitoring exercise activity and responses of a patient (Begun; abstract) including identifying the user by means of a profile of the user stored in a memory of the processing and memory unit when the user begins the therapy session (the system establishes a sessions protocol file for the patient stored on program disk 220a, including information such as the patient’s unique I.D. number; the file is read whenever the patient begins a therapy session to obtain session parameters) (Begun; col. 12 lines 9-54).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Pelerossi method such that the Gonnen processor and working memory is modified to additionally identify the user by means of a profile of the user stored in a memory of the processing and memory unit when the user begins the therapy session, as taught by Begun, for the purpose of ensuring that unique patient’s therapy session parameters are applied for that session (Begun; col. 12 lines 9-54).
Regarding claim 10, the modified Pelerossi teaches identifying a profile of the user stored in the sensor unit when the user begins the therapy session (the system establishes a sessions protocol file for the patient stored on program disk 220a, including information such as the patient’s unique I.D. number; the file is read whenever the patient begins a therapy session to obtain session parameters) (Begun; col. 12 lines 9-54).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Pelerossi in view of Sather, Gonnen, Baumert, and Begun as applied to claim 2 above, and further in view of Chang et al. (US 2013/0023738 A1).
Regarding claim 3, the modified Pelerossi teaches the invention as previously claimed, including the sensor unit is enabled the user to turn the device on to start the therapy session (microphone 12 would have to be on in order to function to detect the audible signal 24 responsive to the user’s spirometric flow through the acoustic transducer device 20a during use) (Gonnen; Figs. 1a, 2c-2d; para. [0037]; para. [0046]; para. [0062]), but does not teach providing an on/off switch.
However, Chang teaches a mobile phone for inspecting a user’s health (Chang; abstract; para. [0002]) including providing an on/off switch to the sensor unit to enable the user to turn the device on (system with a sensor and controller is connected to a processor 110, and the sensor is integrated with a control component of a mobile phone such as a power-on button) (Chang; para. [0021]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Pelerossi method such that the sensor unit (i.e. the Gonnen mobile computer device 1 with microphone 12) (Gonnen; Figs. 1a, 2d; para. [0009]) is also provided with an on/off switch, as taught by Chang, for the purpose of ensuring a user has a means to manually turn the sensor unit on and off, thereby allowing the user to conserve power when the device is not in use.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Pelerossi in view of Sather, Gonnen, and Baumert as applied to claim 9 above, and further in view of Chang.
Regarding claim 11, the modified Pelerossi teaches the invention as previously claimed, including the sensor unit is enabled to turn on of the sensor unit when the user starts the therapy session (microphone 12 would have to be on in order to function to detect the audible signal 24 responsive to the user’s spirometric flow through the acoustic transducer device 20a during use) (Gonnen; Figs. 1a, 2c-2d; para. [0037]; para. [0046]; para. [0062]), but does not teach providing an on/off switch.
However, Chang teaches a mobile phone for inspecting a user’s health (Chang; abstract; para. [0002]) including providing an on/off switch to the sensor unit to enable the user to turn the device on (system with a sensor and controller is connected to a processor 110, and the sensor is integrated with a control component of a mobile phone such as a power-on button) (Chang; para. [0021]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Pelerossi method such that the sensor unit (i.e. the Gonnen mobile computer device 1 with microphone 12) (Gonnen; Figs. 1a, 2d; para. [0009]) is also provided with an on/off switch, as taught by Chang, for the purpose of ensuring a user has a means to manually turn the sensor unit on and off, thereby allowing the user to conserve power when the device is not in use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2012/0304988 A1 by Meyer et al. is considered to be relevant as it discloses an oscillating positive expiratory pressure device with a means to adjust the oscillation frequency.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
