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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 7, 9, 10, and 16 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Shau et al. (US 20160346491 A1).
Regarding claim 1, Shau discloses an aerosol amount detection method (Medication Concentration Detecting Device for Nebulizer; title; figure 1-8C), which is adapted to a nebulizer ([0022] atomizer 110; figure 2), the aerosol detection method comprising:
continuously emitting, by a light detection circuit ([0021] a light-blocking member 30, a light emitting member 40, a first light receiver 50a and a processor 60; figure 2 and 4), a plurality of light signals to an aerosol path of the nebulizer (see [0026]-[0029], figure 2 and 3B: light emitting member 40) for obtaining a plurality of light intensity values ([0033] When the light beam L is emitted into the passageway S2 from the first light transmitting area 30a along an extending direction of the first central line P1, the light beam L hitting the nebulized medicine M is scattered. Part of the scattered light beam L leaves the passageway S2 through the second light transmitting area 30b of the light-blocking member 30 and then reaches the light receiving surface 51 of the first light receiver 50a. When the first light receiver 50a receives the scattered light beam L, it transmits a luminous flux signal to the processor 60; figure 3B-4);
calculating, by a control circuit ([0021] processor 60; figure 2), an aerosol amount index of the aerosol path according to the plurality of light intensity values ([0033] The processor 60 calculates a luminous flux reference value according to the luminous flux signal transmitted from the first light receiver 50a. The luminous flux reference value is used for determining whether outputs a low nebulized medicine concentration warning. The low nebulized medicine concentration warning is used for notifying the patient that the concentration of the nebulized medicine M is insufficient); and
outputting, by the control circuit, a warning signal when the aerosol amount index continues to be less than a stop threshold for a first check time ([0034] Specifically, when the luminous flux reference value calculated by the processor 60 is lower than a predetermined lower limit value, which indicates the concentration of the nebulized medicine M is insufficient, the processor 60 outputs a warning signal to the warning member 70. The warning member 70 generates warning information according to the warning signal. The warning information is not limited to visual information or audio information).
Regarding claim 7, Shau discloses the aerosol amount detection method according to claim 1, further comprising: receiving, by the light detection circuit, a plurality of reflected light signals after the light detection circuit continuously emits the plurality of light signals to the aerosol path ([0033] When the light beam L is emitted into the passageway S2 from the first light transmitting area 30a along an extending direction of the first central line P1, the light beam L hitting the nebulized medicine M is scattered. Part of the scattered light beam L leaves the passageway S2 through the second light transmitting area 30b of the light-blocking member 30 and then reaches the light receiving surface 51 of the first light receiver 50a. When the first light receiver 50a receives the scattered light beam L, it transmits a luminous flux signal to the processor 60; figure 3B-4), and obtaining the light intensity values of the reflected light signals ([0033] When the first light receiver 50a receives the scattered light beam L, it transmits a luminous flux signal to the processor 60. The processor 60 calculates a luminous flux reference value according to the luminous flux signal transmitted from the first light receiver 50a. Examiner notes luminous flux is a measure of light intensity).
Regarding claim 9, Shau discloses a nebulizer ([0019] a medication concentration detecting device 1a for nebulizer; figure 1-8C), comprising:
a cup configured to store a medical liquid ([0022] The medicine container 10 has a first air inlet 11, a first air outlet 13 and a chamber S1…An atomizer 110 is disposed in the chamber S1, which causes the pure oxygen to flow through a liquid medicine at a high velocity so as to turn it into an aerosol (e.g. the nebulized medicine M) by the pressure difference; figure 1-2);
a nebulizing module connected to the cup ([0022] Atomizer 110; figure 1-2), wherein the nebulizing module is configured to convert the medical liquid into an aerosol ([0022] An atomizer 110 is disposed in the chamber S1, which causes the pure oxygen to flow through a liquid medicine at a high velocity so as to turn it into an aerosol (e.g. the nebulized medicine M) by the pressure difference; figure 1-2) and spread the aerosol to an aerosol path ([0023] T-shaped passageway S2… The second air inlet 21 is connected to the first air outlet 13 of the medicine container 10, allowing the nebulized medicine M to flow into the passageway S2 from the chamber S1. Furthermore, the second air outlet 23 is connected to a mouthpiece (not shown) configured for the patient to inhale the nebulized medicine M.; figure 1-3B);
a host connected to the cup ([0024] the light-blocking member 30 is detachably disposed on the three-way pipe 20; figure 2);
a light detection circuit disposed inside the host ([0021] a light emitting member 40, a first light receiver 50a; figure 2 and 4); and
a control circuit disposed inside the host and connected to the light detection circuit ([0021] processor 60; figure 2 and 4);
wherein the light detection circuit is configured to continuously emit a plurality of light signals to the aerosol path (see [0026]-[0029], figure 2 and 3B: light emitting member 40) for obtaining a plurality of light intensity values ([0033] When the light beam L is emitted into the passageway S2 from the first light transmitting area 30a along an extending direction of the first central line P1, the light beam L hitting the nebulized medicine M is scattered. Part of the scattered light beam L leaves the passageway S2 through the second light transmitting area 30b of the light-blocking member 30 and then reaches the light receiving surface 51 of the first light receiver 50a. When the first light receiver 50a receives the scattered light beam L, it transmits a luminous flux signal to the processor 60; figure 3B-4);
wherein the control circuit is configured to calculate an aerosol amount index of the aerosol path according to the plurality of light intensity values ([0033] The processor 60 calculates a luminous flux reference value according to the luminous flux signal transmitted from the first light receiver 50a. The luminous flux reference value is used for determining whether outputs a low nebulized medicine concentration warning. The low nebulized medicine concentration warning is used for notifying the patient that the concentration of the nebulized medicine M is insufficient);
wherein, when the control circuit determines that the aerosol amount index continues to be less than a stop threshold for a first check time, the control circuit outputs a warning signal time ([0034] Specifically, when the luminous flux reference value calculated by the processor 60 is lower than a predetermined lower limit value, which indicates the concentration of the nebulized medicine M is insufficient, the processor 60 outputs a warning signal to the warning member 70. The warning member 70 generates warning information according to the warning signal. The warning information is not limited to visual information or audio information).
Regarding claim 10, Shau discloses the nebulizer according to claim 9, wherein the control circuit includes an input interface ([0033] The processor 60 calculates a luminous flux reference value according to the luminous flux signal transmitted from the first light receiver 50a. Examiner notes the input interface of processor 60 is not explicitly disclosed but is required to receive the transmitted luminous flux signal), a central processing unit ([0021] processor 60), a memory ([0021] processor 60. Examiner notes a memory is an inherent property of a processor), a timer ([0021] processor 60. Examiner notes an internal clock or timer is an inherent property of a processor ), and an output interface ([0034] the processor 60 outputs a warning signal to the warning member 70. Examiner notes the output interface of processor 60 is not explicitly disclosed but is required to output a warning signal), the central processing unit is electrically connected to the input interface, the memory, the timer, and the output interface (the component above are part of or connected to processor 60), the memory stores a stop threshold ([0034] when the luminous flux reference value calculated by the processor 60 is lower than a predetermined lower limit value. Examiner notes the comparison of the calculated luminous flux reference value to the predetermined lower limit value is performed at the processor 60; therefore the memory of processor 60 stores the predetermined lower limit value to use during comparison), the input interface receives the plurality of light intensity values ([0033] The processor 60 calculates a luminous flux reference value according to the luminous flux signal transmitted from the first light receiver 50a), and the central processing unit calculates the aerosol amount index ([0034] the luminous flux reference value calculated by the processor 60); wherein, when the central processing unit determines that the aerosol amount index continues to be less than the stop threshold for the first check time, the central processing unit outputs the warning signal through the output interface ([0034] Specifically, when the luminous flux reference value calculated by the processor 60 is lower than a predetermined lower limit value, which indicates the concentration of the nebulized medicine M is insufficient, the processor 60 outputs a warning signal to the warning member 70).
Regarding claim 16, Shau discloses the nebulizer according to claim 9, wherein the light detection circuit receives a plurality of reflected light signals from the aerosol path ([0033] When the light beam L is emitted into the passageway S2 from the first light transmitting area 30a along an extending direction of the first central line P1, the light beam L hitting the nebulized medicine M is scattered. Part of the scattered light beam L leaves the passageway S2 through the second light transmitting area 30b of the light-blocking member 30 and then reaches the light receiving surface 51 of the first light receiver 50a. When the first light receiver 50a receives the scattered light beam L, it transmits a luminous flux signal to the processor 60; figure 3B-4) and obtain the light intensity values of the reflected light signals ([0033] When the first light receiver 50a receives the scattered light beam L, it transmits a luminous flux signal to the processor 60. The processor 60 calculates a luminous flux reference value according to the luminous flux signal transmitted from the first light receiver 50a. Examiner notes luminous flux is a measure of light intensity).
Claim Rejections - 35 USC § 103
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.
Claim(s) 2-3 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shau et al. (US 20160346491 A1) as applied to claim 1 and 9, respectively, above, and further in view of Hebrank et al. (US 20200276398 A1).
Regarding claim 2, Shau discloses the aerosol amount detection method according to claim 1, but is silent as to wherein, when the warning signal continues for a second check time, the control circuit stops driving a nebulizing module of the nebulizer.
Shau teaches [0050] when the nebulized medicine is known to be running out, the pure oxygen provider will be turned off for preventing the waste of pure oxygen.
Additionally, Hebrank teaches an in-line droplet delivery device (title; figure 1-2) wherein the device is powered off after an amount of time where no additional dose medicine dispensing is detected. Specifically, Hebrank teaches [0128] 2. As a patient inhales, a pre-set pressure value is reached and detected by the pressure sensor located within the housing (e.g., delta P sensor) and a second audible indicator or LED indicator may now indicate that a dose is triggered. After the dose is triggered and delivered, another audible and/or LED indicator may trigger until a spray cycle time of, e.g, 1-5 seconds (or other designated dosing time) ends. Further, if desired, when a dose is delivered, the dose counter displayed on the LCD will indicate that a dose was delivered by a decrease in number of doses displayed on the LCD. [0129] 3. If no additional doses are required and a time of, e.g., 15 seconds elapse, an audible and/or LED indicator may trigger to alert the user that the device is about to power-off, after which time the device may enter into a low power, sleep mode.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the processor of Shau to implement when the nebulized medicine is known to be running out, via the warning signal, a 15 second time window where if there is no additional dosing, an audible and/or LED indicator may trigger to alert the user that the device is about to power-off, after which time the device may enter into a low power, sleep mode, as taught by Hebrank, where the pure oxygen provider will be turned off thereby stopping nebulization of the medicine, in order to prevent the waste of oxygen while informing the patient ahead of time so they may take a subsequent action.
Regarding claim 3, modified Shau teaches the aerosol amount detection method according to claim 2, further comprising: sending, by the control circuit, an activating signal to the nebulizing module for a buffer time after the aerosol amount index is less than the stop threshold (as per the modification above, the nebulization of the medicine is not stopped until after the 15 second window that is activated when the nebulized medicine is known to be running out, via the warning signal; therefore an activation signal to atomizer is uninterrupted till after the 15 second window); wherein the buffer time is a sum of the first check time and the second check time (Examiner notes that since the processor sends out the warning signal as soon as the concentration of the nebulized medicine M is determined to be insufficient, the first check time is or close to zero, therefore the 15 second window is the sum of the first check time, zero, and the second check time, 15 seconds).
Regarding claim 11, Shau discloses the nebulizer according to claim 9, but is silent as to wherein, when the warning signal continues for a second check time, the control circuit stops driving the nebulizing module.
Shau teaches [0050] when the nebulized medicine is known to be running out, the pure oxygen provider will be turned off for preventing the waste of pure oxygen.
Additionally, Hebrank teaches an in-line droplet delivery device (title; figure 1-2) wherein the device is powered off after an amount of time where no additional dose medicine dispensing is detected. Specifically, Hebrank teaches [0128] 2. As a patient inhales, a pre-set pressure value is reached and detected by the pressure sensor located within the housing (e.g., delta P sensor) and a second audible indicator or LED indicator may now indicate that a dose is triggered. After the dose is triggered and delivered, another audible and/or LED indicator may trigger until a spray cycle time of, e.g, 1-5 seconds (or other designated dosing time) ends. Further, if desired, when a dose is delivered, the dose counter displayed on the LCD will indicate that a dose was delivered by a decrease in number of doses displayed on the LCD. [0129] 3. If no additional doses are required and a time of, e.g., 15 seconds elapse, an audible and/or LED indicator may trigger to alert the user that the device is about to power-off, after which time the device may enter into a low power, sleep mode.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the processor of Shau to implement when the nebulized medicine is known to be running out, via the warning signal, a 15 second time window where if there is no additional dosing, an audible and/or LED indicator may trigger to alert the user that the device is about to power-off, after which time the device may enter into a low power, sleep mode, as taught by Hebrank, where the pure oxygen provider will be turned off thereby stopping nebulization of the medicine, in order to prevent the waste of oxygen while informing the patient ahead of time so they may take a subsequent action.
Regarding claim 12, modified Shau teaches the nebulizer according to claim 11, wherein the control circuit continues to send an activating signal to the nebulizing module for a buffer time after the aerosol amount index is less than the stop threshold (as per the modification above, the nebulization of the medicine is not stopped until after the 15 second window that is activated when the nebulized medicine is known to be running out, via the warning signal; therefore an activation signal to atomizer is uninterrupted till after the 15 second window), and the buffer time is a sum of the first check time and the second check time (Examiner notes that since the processor sends out the warning signal as soon as the concentration of the nebulized medicine M is determined to be insufficient, the first check time is or close to zero, therefore the 15 second window is the sum of the first check time, zero, and the second check time, 15 seconds).
Claim(s) 4 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shau et al. (US 20160346491 A1) as applied to claim 1 and 9, respectively, above, and further in view of Otiaba et al. (US 20200352245 A1)
Regarding claim 4, Shau discloses the aerosol amount detection method according to claim 1, but is silent as to further comprising: determining, by the control circuit, whether or not a detection value converted from the light intensity value is greater than a stable threshold before the control circuit calculates the aerosol amount index of the aerosol path according to the plurality of light intensity values; wherein, when the detection value is greater than the stable threshold, the control circuit calculates the aerosol amount index of the aerosol path according to the plurality of light intensity values.
However, Otiaba teaches an optical liquid detection system for a vaporizing device (abstract) wherein a detection value converted from a light intensity value is greater than a stable threshold before being used to calculate a reservoir level ([0068] the system is configured to deduce that if light emitted from the source 50 is received at one or more detectors 52, liquid is present in the reservoir 21 and causing scattering of the emitted light. If no detectors detect any light, scattering is absent and it is deduced that the reservoir contains no liquid, or contains liquid only at a level below the lowest reservoir depth through which the direct optical path passes. The optical source may be arranged at or near the base of the reservoir so that a null result (no detected scattered light) more accurately corresponds to an empty or near-empty reservoir. The actual amount of light at any detector is not significant; the detection of light per se is sufficient to identify scattering that indicates the presence of liquid. However, a detection threshold might be included in the assessment of the detector outputs, where levels of detected light below the threshold are disregarded. This can exclude potential false positive results owing to noise or error at a detector or the detection of ambient or other light that has not arisen from scattering in liquid).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the processor of Shau to implement a detection threshold included in the assessment of the detector outputs, where levels of detected light below the threshold are disregarded, in order to exclude potential false positive results owing to noise or error at a detector or the detection of ambient or other light that has not arisen from scattering as taught by Otiaba [0068]. As such if there are no detector outputs above the threshold, the aerosol amount index cannot be calculated since there are no valid outputs, and the aerosol amount index is only calculated after the processor receives valid outputs.
Regarding claim 13, Shau discloses the nebulizer according to claim 9, but is silent as to wherein, when a detection value converted from the light intensity value is greater than a stable threshold, the control circuit calculates the aerosol amount index of the aerosol path according to the plurality of light intensity values.
However, Otiaba teaches an optical liquid detection system for a vaporizing device (abstract) wherein a detection value converted from a light intensity value is greater than a stable threshold before being used to calculate a reservoir level ([0068] the system is configured to deduce that if light emitted from the source 50 is received at one or more detectors 52, liquid is present in the reservoir 21 and causing scattering of the emitted light. If no detectors detect any light, scattering is absent and it is deduced that the reservoir contains no liquid, or contains liquid only at a level below the lowest reservoir depth through which the direct optical path passes. The optical source may be arranged at or near the base of the reservoir so that a null result (no detected scattered light) more accurately corresponds to an empty or near-empty reservoir. The actual amount of light at any detector is not significant; the detection of light per se is sufficient to identify scattering that indicates the presence of liquid. However, a detection threshold might be included in the assessment of the detector outputs, where levels of detected light below the threshold are disregarded. This can exclude potential false positive results owing to noise or error at a detector or the detection of ambient or other light that has not arisen from scattering in liquid).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the processor of Shau to implement a detection threshold included in the assessment of the detector outputs, where levels of detected light below the threshold are disregarded, in order to exclude potential false positive results owing to noise or error at a detector or the detection of ambient or other light that has not arisen from scattering as taught by Otiaba [0068]. As such if there are no detector outputs above the threshold, the aerosol amount index cannot be calculated since there are no valid outputs, and the aerosol amount index is only calculated after the processor receives valid outputs.
Claim(s) 5-6 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shau et al. (US 20160346491 A1) and Otiaba et al. (US 20200352245 A1) as applied to claim 4 and 13, respectively, above, and further in view of Altobelli et al. (US 20050068528 A1) and Park et al. (US 20230045457 A1).
Regarding claim 5, modified Shau teaches the aerosol amount detection method according to claim 4, but is silent as to wherein, after the control circuit calculates the aerosol amount index of the aerosol path according to the plurality of light intensity values, the control circuit determines whether or not a change amount of the aerosol amount index is within a stable interval; wherein, when the change amount is within the stable interval, the aerosol amount index is in a stable state.
However, Altobelli teaches an aerosol detection system (title and abstract) wherein [0050] The processor, at step 412, can use the received signals to calculate the amount of the second aerosol that traverses the flow path. At step 413, the processor compares the amount of the first aerosol detected with the amount of the second aerosol detected, and outputs a signal associated with the difference between the two at step 414, see figure 4.
Additionally, Park teaches an aerosol detection system (abstract) wherein [0134] According to an embodiment, when the difference between the first detected value and the second detected value is included within the predetermined reference range, the controller 160 may calculate the remaining amount of the aerosol generating material based on at least any one of the first detected value and the second detected value.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the processor of Shau to compare the amount of the first aerosol detected with the amount of the second aerosol detected, and outputs a signal associated with the difference, as taught by Altobelli, indicating if the difference is within a predetermined reference range, thereby indicating if the change in aerosol detected is in a stable reference range, as taught by Park, in order to provide additional information to aid in metering subsequent aerosols, see Altobelli [0019].
Regarding claim 6, modified Shau teaches the aerosol amount detection method according to claim 5, but is silent as to wherein, when the aerosol amount index is in the stable state, the control circuit calculates an average aerosol amount index, and the stop threshold is the average aerosol amount index divided by a stop parameter.
However, Park teaches [0134] According to an embodiment, when the difference between the first detected value and the second detected value is included within the predetermined reference range, the controller 160 may calculate the remaining amount of the aerosol generating material based on at least any one of the first detected value and the second detected value. [0135] As another example, the controller 160 may calculate the remaining amount of the aerosol generating material based on an average value of the first detected value and the second detected value.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the processor of Shau to implement calculating a luminous flux reference value based on an average value of the first and second luminous flux signal, thereby including an aggregate of a plurality of signals during a time where the change in aerosol detected is in a stable reference range, as taught by Park, thus making the aerosol amount index more reliable.
Regarding the stop threshold is the average aerosol amount index divided by a stop parameter.
As supported by Applicant’s specification pg. 13 [0044], the stop parameter is a set parameter that is selected based on the type of medical liquid in the cup in order to judge the end of nebulization. Examiner notes that one of ordinary skill in the art is capable of using an average aerosol amount index calculated at the start of nebulization or during a previous calibration trail run and select a stop parameter, based on the type of medical liquid to be nebulized, in order to obtain the predetermined lower limit value for the luminous flux reference value.
Regarding claim 14, modified Shau teaches the nebulizer according to claim 13, wherein, but is silent as to when a change amount of the aerosol amount index is within a stable interval, the aerosol amount index is in a stable state.
However, Altobelli teaches an aerosol detection system (title and abstract) wherein [0050] The processor, at step 412, can use the received signals to calculate the amount of the second aerosol that traverses the flow path. At step 413, the processor compares the amount of the first aerosol detected with the amount of the second aerosol detected, and outputs a signal associated with the difference between the two at step 414, see figure 4.
Additionally, Park teaches an aerosol detection system (abstract) wherein [0134] According to an embodiment, when the difference between the first detected value and the second detected value is included within the predetermined reference range, the controller 160 may calculate the remaining amount of the aerosol generating material based on at least any one of the first detected value and the second detected value.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the processor of Shau to compare the amount of the first aerosol detected with the amount of the second aerosol detected, and outputs a signal associated with the difference, as taught by Altobelli, indicating if the difference is within a predetermined reference range, thereby indicating if the change in aerosol detected is in a stable reference range, as taught by Park, in order to provide additional information to aid in metering subsequent aerosols, see Altobelli [0019].
Regarding claim 15, modified Shau teaches the nebulizer according to claim 14, wherein, but is silent as to when the aerosol amount index is in the stable state, the control circuit calculates an average aerosol amount index, and the stop threshold is the average aerosol amount index divided by a stop parameter.
However, Park teaches [0134] According to an embodiment, when the difference between the first detected value and the second detected value is included within the predetermined reference range, the controller 160 may calculate the remaining amount of the aerosol generating material based on at least any one of the first detected value and the second detected value. [0135] As another example, the controller 160 may calculate the remaining amount of the aerosol generating material based on an average value of the first detected value and the second detected value.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the processor of Shau to implement calculating a luminous flux reference value based on an average value of the first and second luminous flux signal, thereby including an aggregate of a plurality of signals during a time where the change in aerosol detected is in a stable reference range, as taught by Park, thus making the aerosol amount index more reliable.
Regarding the stop threshold is the average aerosol amount index divided by a stop parameter.
As supported by Applicant’s specification pg. 13 [0044], the stop parameter is a set parameter that is selected based on the type of medical liquid in the cup in order to judge the end of nebulization. Examiner notes that one of ordinary skill in the art is capable of using an average aerosol amount index calculated at the start of nebulization or during a previous calibration trail run and select a stop parameter, based on the type of medical liquid to be nebulized, in order to obtain the predetermined lower limit value for the luminous flux reference value.
Claim(s) 8 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shau et al. (US 20160346491 A1) as applied to claim 1 and 9, respectively, above, and further in view of Kuczaj et al. (US 20250256043 A1).
Regarding claim 8, Shau discloses the aerosol amount detection method according to claim 1, wherein the control circuit calculates at least one aerosol parameter of the aerosol path according to the plurality of light intensity values ([0034] Specifically, when the luminous flux reference value calculated by the processor 60 is lower than a predetermined lower limit value, which indicates the concentration of the nebulized medicine M is insufficient, the processor 60 outputs a warning signal to the warning member 70), but is silent as to the control circuit controls a vibration frequency of the nebulizing module to adjust the at least one aerosol parameter.
However, Kuczaj teaches an aerosol generating device (abstract) wherein the control circuit controls a vibration frequency of the nebulizing module to adjust an aerosol concentration ([0027] For example, the settings determination unit may automatically adjust the frequency of vibration of the mesh of the heating system of the device, such that a new frequency of vibration is determined which corresponds to a new aerosol concentration or dose. The settings determination unit may then adapt the aerosol data of the respiratory system model based on the new aerosol concentration or dose, hence ensuring that the model is fed with updated aerosol data corresponding to the new aerosol concentration or dose, to be able to determine a more accurate aerosol deposition in a specific region of interest, target lung depth level, or airway generation of the respiratory system model corresponding to the user of the device).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the processor of Shau to implement automatically adjusting a frequency of vibration of the atomizer to correspond to a new aerosol concentration in order to ensure the aerosol concentration is accurately supplied based on the user’s needs, as taught by Kuczaj [0027].
Regarding claim 17, Shau discloses the nebulizer according to claim 9, wherein the control circuit calculates at least one aerosol parameter of the aerosol path according to the plurality of light intensity values ([0034] Specifically, when the luminous flux reference value calculated by the processor 60 is lower than a predetermined lower limit value, which indicates the concentration of the nebulized medicine M is insufficient, the processor 60 outputs a warning signal to the warning member 70), but is silent as to the control circuit controls a vibration frequency of the nebulizing module to adjust the at least one aerosol parameter.
However, Kuczaj teaches an aerosol generating device (abstract) wherein the control circuit controls a vibration frequency of the nebulizing module to adjust an aerosol concentration ([0027] For example, the settings determination unit may automatically adjust the frequency of vibration of the mesh of the heating system of the device, such that a new frequency of vibration is determined which corresponds to a new aerosol concentration or dose. The settings determination unit may then adapt the aerosol data of the respiratory system model based on the new aerosol concentration or dose, hence ensuring that the model is fed with updated aerosol data corresponding to the new aerosol concentration or dose, to be able to determine a more accurate aerosol deposition in a specific region of interest, target lung depth level, or airway generation of the respiratory system model corresponding to the user of the device).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the processor of Shau to implement automatically adjusting a frequency of vibration of the atomizer to correspond to a new aerosol concentration in order to ensure the aerosol concentration is accurately supplied based on the user’s needs, as taught by Kuczaj [0027].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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