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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/09/2026 has been entered.
Response to Amendments
This office action is responsive to the amendment filed on 02/09/2026. As directed by the amendment: claims 1-6, 9, 11-13, 15-16, and 19 have been amended, no claims have been canceled, and no new claims have been added. Thus, claims 1-20 are presently pending in the application.
Claim Objections
Claim 1 is objected to because of the following informalities: Line 12 of claim 1 and line 10 of claim 11 recites, “configured to module the high-frequency oscillation signal”, and should instead read, “configured to modulate the high-frequency oscillation signal”. Appropriate correction is required.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The terms “waveform determination circuit”, “signal modulator”, “signal filtering circuit”, “neural network processing circuit”, and “transceiver”, used throughout the claims should be recited in the specification.
The limitation, “wherein an average particle size of the pharmaceutical aerosols varies according to a frequency of the modulation control signal, and wherein the signal modulator performs continuous modulation of the high-frequency oscillation signal using the modulation control signal, such that the particle size of the generated pharmaceutical aerosols dynamically changes in response to the breathing state of the patient,” set forth in lines 20-24 of claim 1 and lines 16-20 of claim 11 should be recited in the specification.
Claim Interpretation
The limitation “continuous” first recited in line 21 of claim 1 is not defined by the specification and is reasonably understood according to its plain meaning as being able perform in a way that keeps occurring.
The limitation “dynamically changes” first recited in line 23 of claim 1 is not explicitly defined or specified by the specification and is reasonably understood according to its plain meaning as a “usually continuous change”.
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, 11, 14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN 111420188 A) in view of Segal (US 20200330719 A1), in view of Kelliher (US 20070256684 A1), in view of Jackson (US 20200290077 A1).
Regarding claim 1, Chen discloses an atomizer (Abstract: High-efficiency vibrating atomizer) for adaptively generating a plurality of pharmaceutical aerosols (Set forth in [0014] of the machine translation with labeled paragraph numbers) with deferment particle sizes, comprising: a waveform determination circuit, configured to generate a modulation control signal (Set forth in [0086]: A driving circuit composed of a signal generator circuit); a high-frequency oscillation, configured to provide a high-frequency oscillation signal circuit (Set forth in [0086]: A driving circuit composed of a phase shift circuit); a signal modulator (Set forth in [0084]: FIG. 8 A high-frequency vibration module 9), electrically connected to the waveform determination circuit and the high-frequency oscillation circuit (FIG. 8 shows the high-frequency vibration module 9 and the ultrasonic motor 101 driving circuit are connected. FIG. 9 is the driving circuit composed of the signal generator circuit and the phase shift circuit set forth in [0086]), configured to module the high-frequency oscillation signal by using the modulation control signal to generate a vibration signal (Set forth in [0084]: said high frequency vibration module comprises using the inverse piezoelectric effect of the piezoelectric material, converting the electric energy into mechanical vibration energy); a piezoelectric device (Piezoelectric thin film under the action of alternating electric field generates the converse piezoelectric effect set forth in [0085] with the vibrating mesh structure 4 shown in FIG. 8 and set forth in [0085]), electrically connected to the signal modulator (Driven by high-frequency vibration module set forth in [0085]), configured to vibrate according to the vibration signal; and a porous screen (FIG. 3 and 4 represent the first embodiment of the invention, but show the microporous plate 43 set forth in [0089] as being used in the second embodiment of the invention as well), physically connected to the piezoelectric device (The microporous plate is driven by the piezoelectric material set forth in the abstract, reasonably indicating that they would be physically connected).
Chen fails to explicitly disclose a sensor module, configured to sense a body state of a patient, wherein the body state comprises a breathing state, electrically connected to the waveform determination circuit configured to generate a modulation control signal according to the body state.
However, Segal teaches a sensor module (Segal: FIG. 1A-B, 2A, 7A-B, 8, and 10 Nebulizer monitoring system 100 set forth in [0095]), configured to sense a body state of a patient (Segal: Set forth in [0095]-[0096] where the breathing state read by the Nebulizer monitoring system 100 is displayed on user dashboard 900 shown in FIG. 9, which can include an accelerometer or flow sensors 222 shown in FIG. 10 to sense motion as set forth in [0059] and [0100], or flow rate set forth in [0100]), wherein the body state comprises a breathing state (Segal: The breathing state can be indicated by the breathing pattern, breaths per minute, set forth in [0096] or the flow rate determined flow sensors 222 set forth in [0100]), electrically connected to a controller (Segal: the Accelerometer 280 is communicatively connected to controller 230 and sends acceleration data to the controller 230 set forth in [0059] and [0100] as well as the flow sensors 222 set forth in [0100]) configured to generate a control signal according to the body state (Segal: FIG. 11 The detected motion thereby causes the device to awake 1108, where the device is turned on 1110 and begins operation. Additionally, some embodiments can include vibrating members, for example, that can change vibration intensities based on the flow rate of air as set forth in [0079]).
Chen and Segal are both considered to be analogous to the claimed invention because they are in the same field of drug delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Segal and include a sensor module (Segal: FIG. 1A-B, 2A, 7A-B, 8, and 10 Nebulizer monitoring system 100 set forth in [0095]), configured to sense a body state of a patient (Segal: Set forth in [0095]-[0096] where the breathing state read by the Nebulizer monitoring system 100 is displayed on user dashboard 900 shown in FIG. 9, which can include an accelerometer or flow sensors 222 shown in FIG. 10 to sense motion as set forth in [0059] and [0100], or flow rate set forth in [0100]), wherein the body state comprises a breathing state (Segal: The breathing state can be indicated by the breathing pattern, breaths per minute, set forth in [0096] or the flow rate determined flow sensors 222 set forth in [0100]), electrically connected to a controller (Segal: the Accelerometer 280 is communicatively connected to controller 230 and sends acceleration data to the controller 230 set forth in [0059] and [0100] as well as the flow sensors 222 set forth in [0100]) configured to generate a control signal according to the body state (Segal: FIG. 11 The detected motion thereby causes the device to awake 1108, where the device is turned on 1110 and begins operation. Additionally, some embodiments can include vibrating members, for example, that can change vibration intensities based on the flow rate of air as set forth in [0079]). It would be reasonable that by electrically connecting the sensor module to the waveform determination circuit would allow the sensor module to generate a modulation control signal according to the body state. Doing so would allow for the detection of start of use of the nebulizer and allow for the state of the user and doses taken using the nebulizer to be indicated (Segal: Set forth in [0057] and [0011]).
While Chen as modified discloses a sensor module connected to a waveform determination module allowing it to generate a control signal according to the body state (Segal: Some embodiments can include vibrating members, for example, that can change vibration intensities based on the flow rate of air as set forth in [0079]), it fails to explicitly disclose wherein the pharmaceutical aerosols have the particle size(s) corresponding to the modulation control signal, wherein the average size of the pharmaceutical aerosols varies according to a frequency of the modulation control signal.
However, Kelliher teaches wherein the pharmaceutical aerosols have the particle size(s) corresponding to vibration intensity (Kelliher: The frequency of vibrations can be varied depending upon the desired target size range for the resulting aerosol, mist or spray).
Chen and Kelliher are both considered to be analogous to the claimed invention because they are in the same field of drug delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Kelliher and include wherein the pharmaceutical aerosols have the particle size(s) corresponding to vibration intensity (Kelliher: The frequency of vibrations can be varied depending upon the desired target size range for the resulting aerosol, mist or spray). Doing so would mean that the particle size of the pharmaceutical aerosols would correspond to the control signal, given that the frequency of vibrations can be varied depending upon the desired target size range for the resulting aerosol, mist or spray (Kelliher: Set forth in [0056]). Given that the in view of the modification by Segal, regarding the ability of the device to change vibration intensities based on a body state, and Kelliher, regarding the frequency of vibrations particle size, above, the particle size of the pharmaceutical aerosols would correspond to the control signal, and it would mean that the average size of the pharmaceutical aerosols would vary according to a frequency of the modulation control signal.
Additionally, Given that the signal modulator (Set forth in [0084]: FIG. 8 A high-frequency vibration module 9), is configured to module the high-frequency oscillation signal by using the modulation control signal to generate a vibration signal (Set forth in [0084]: said high frequency vibration module comprises using the inverse piezoelectric effect of the piezoelectric material, converting the electric energy into mechanical vibration energy), it would mean that, provided the modifications by Segal and Kelliher, the signal modulator would perform continuous modulation of the high-frequency oscillation signal using the modulation control signal, such that the particle size of the generated pharmaceutical aerosols dynamically changes in response to the breathing state of the patient. Specifically, in Segal, FIG. 11 The detected motion thereby causes the device to awake 1108, where the device is turned on 1110 and begins operation. Additionally, some embodiments can include vibrating members, for example, that can change vibration intensities based on the flow rate of air as set forth in [0079], the vibration intensities corresponding to particle size; Kelliher: The frequency of vibrations can be varied depending upon the desired target size range for the resulting aerosol, mist or spray; the signal modulator providing continuous modulation in that it is able to operate in a manner wherein the change in vibration keeps occurring, whether it be at different frequencies, or turned completely off and then on, and the particle sizes are dynamically changing given term is being take to mean that are being changed in a usually continuous manner, according to whether the device is turned on or off, or according to the vibration intensity, which are performed according to the body state as taught by Segal).
Chen as modified fails to explicitly disclose the porous screen is configured to press liquid medicine through a plurality of holes of the porous screen to generate the plurality of pharmaceutical aerosols according to vibration of the piezoelectric device.
However, Jackson teaches a porous screen configured to press liquid medicine (Jackson: The mention of medicinal efficacy indicates it could be a liquid medicine) through a plurality of holes (Jackson: FIG. 8a Mesh with a plurality of holes 51 set forth in [0080]) of the porous screen to generate the plurality of pharmaceutical aerosols according to vibration of the piezoelectric device (Jackson: When mesh vibrates the fluid from the tank passes through the plurality of holes in mesh set forth in [0080]).
Chen and Jackson are both considered to be analogous to the claimed invention because they are in the same field of atomization devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Jackson and include a porous screen configured to press liquid medicine (Jackson: The mention of medicinal efficacy indicates it could be a liquid medicine) through a plurality of holes (Jackson: FIG. 8a Mesh with a plurality of holes 51 set forth in [0080]) of the porous screen to generate the plurality of pharmaceutical aerosols according to vibration of the piezoelectric device (Jackson: When mesh vibrates the fluid from the tank passes through the plurality of holes in mesh set forth in [0080]). Doing so would allow for the atomization of liquid using a piezoelectric material (Jackson: Abstract).
Chen as modified fails to explicitly disclose, wherein the modulation control signal has a frequency of 0.05 Hz to 10 Hz or that the high-frequency oscillation signal has a frequency of 100kHz.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make modulation control signal have a frequency of 0.05 Hz to 10 Hz and the high-frequency oscillation signal have a frequency of 100kHz in the device of Chen as modified because Applicant has not disclosed that the specific frequency, is used for a particular purpose, or solves a stated problem. Specifically, the specification states in [0040] that “The modulation control signal is usually a low-frequency signal, such as a low-frequency signal of 0.05 Hz to 10 Hz, but the present disclosure is not limited thereto”, and in [0041] that “The frequency of the high- frequency oscillation signal is corresponding to the voltage level of the DC input voltage, i.e., the high-frequency oscillation circuit 15 is a voltage controlled oscillator. For example, the frequency of the high-frequency oscillation signal may be 100 kHz”. However, as explained in MPEP § 2144, subsection II, the discovery of optimum or workable ranges or values are obvious to one of ordinary skill in the art In KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Additionally, In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), it was held that it is not inventive to discover the optimum or workable ranges by routine experimentation. One of ordinary skill in the art, furthermore, would have expected modulation control signal frequency and high-frequency oscillation signal frequency of Chen as modified, and Applicant's frequencies, to perform equally well because both frequencies are used to perform the same function of generating the modulation control signal according to the body state and the auxiliary information and generate a high- frequency oscillation signal is corresponding to the voltage level of the DC input voltage for use for communication and control in the control method of the device.
Therefore, it would have been prima facie obvious to further modify Chen to obtain the invention as specified in claim 1, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired communication or control via the generated signals and thus fails to patentably distinguish over the prior art of Chen.
Regarding claim 4, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Chen further discloses the atomizer further comprising: a direct current/alternative current (DC/AC) converter (AC/DC power supply adapter set forth in [0084]), electrically connected (Shown in the annotated FIGS. 7-9 below) to the high-frequency oscillation circuit (Set forth in [0086]: A driving circuit composed of a phase shift circuit), configured to convert an AC input voltage to a DC input voltage (Inherent definition of an AC/DC adapter), so as to provide the DC input voltage to the high-frequency oscillation circuit, wherein a frequency of the high-frequency oscillation signal generated by the high-frequency oscillation circuit is corresponding to the DC input voltage (DC voltage input by the power supply module and adapter cause the phase shift circuit to function and create a phase difference in the signal as set forth in [0086] which is known in the art as a sinusoidal oscillation signal); and a power amplifier (A power amplifying circuit included in the driving circuit set forth in [0086]), electrically connected between the piezoelectric device and the signal modulator (FIG. 8 The driving circuit connected to the ultrasonic waver motor 101, containing the power amplifying circuit set forth in [0086], which is located between the vibrating mesh structure 4 and the high-frequency vibration module 9 Set forth in [0084]), configured to amplify the vibration signal and output the amplified vibration signal (Inherent definition of a power amplifier) to the piezoelectric device.
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Regarding claim 11, Chen discloses an atomization method for adaptively generating a plurality of pharmaceutical aerosols (Set forth in [0014] of the machine translation with labeled paragraph numbers) with deferment particle sizes, comprising: using a waveform determination circuit, configured to generate a modulation control signal (Set forth in [0086]: A driving circuit composed of a signal generator circuit); using a high-frequency oscillation circuit, to provide a high-frequency oscillation signal (Set forth in [0086]: A driving circuit composed of a phase shift circuit); using a signal modulator (Set forth in [0084]: FIG. 8 A high-frequency vibration module 9, to module the high-frequency oscillation signal by using the modulation control signal to generate a vibration signal (Set forth in [0084]: said high frequency vibration module comprises using the inverse piezoelectric effect of the piezoelectric material, converting the electric energy into mechanical vibration energy); and using a piezoelectric device (Piezoelectric thin film under the action of alternating electric field generates the converse piezoelectric effect set forth in [0085] with the vibrating mesh structure 4 shown in FIG. 8 and set forth in [0085]), to vibrate according to the vibration signal; so as to make a porous screen (FIG. 3 and 4 represent the first embodiment of the invention, but show the microporous plate 43 set forth in [0089] as being used in the second embodiment of the invention as well) vibrate.
Chen fails to explicitly disclose using a sensor module, to sense a body state of a patient, wherein the body state comprises a breathing state to generate a modulation control signal according to the body state.
However, Segal teaches using a sensor module (Segal: FIG. 1A-B, 2A, 7A-B, 8, and 10 Nebulizer monitoring system 100 set forth in [0095]), to sense a body state of a patient (Segal: Set forth in [0095]-[0096] where the breathing state read by the Nebulizer monitoring system 100 is displayed on user dashboard 900 shown in FIG. 9, which can include an accelerometer or flow sensors 222 shown in FIG. 10 to sense motion as set forth in [0059] and [0100], or flow rate set forth in [0100]), wherein the body state comprises a breathing state (Segal: The breathing state can be indicated by the breathing pattern, breaths per minute, set forth in [0096] or the flow rate determined flow sensors 222 set forth in [0100]), to generate a control signal according to the body state (Segal: FIG. 11 The detected motion thereby causes the device to awake 1108, where the device is turned on 1110 and begins operation. Additionally, some embodiments can include vibrating members, for example, that can change vibration intensities based on the flow rate of air as set forth in [0079]).
Chen and Segal are both considered to be analogous to the claimed invention because they are in the same field of drug delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Segal and include using a sensor module (Segal: FIG. 1A-B, 2A, 7A-B, 8, and 10 Nebulizer monitoring system 100 set forth in [0095]), to sense a body state of a patient (Segal: Set forth in [0095]-[0096] where the breathing state read by the Nebulizer monitoring system 100 is displayed on user dashboard 900 shown in FIG. 9, which can include an accelerometer or flow sensors 222 shown in FIG. 10 to sense motion as set forth in [0059] and [0100], or flow rate set forth in [0100]), wherein the body state comprises a breathing state (Segal: The breathing state can be indicated by the breathing pattern, breaths per minute, set forth in [0096] or the flow rate determined flow sensors 222 set forth in [0100]), to generate a control signal according to the body state (Segal: FIG. 11 The detected motion thereby causes the device to awake 1108, where the device is turned on 1110 and begins operation. Additionally, some embodiments can include vibrating members, for example, that can change vibration intensities based on the flow rate of air as set forth in [0079]). It would be reasonable that by electrically connecting the sensor module to the waveform determination circuit would allow the sensor module to generate a modulation control signal according to the body state. Doing so would allow for the detection of start of use of the nebulizer and allow for the state of the user and doses taken using the nebulizer to be indicated (Segal: Set forth in [0057] and [0011]).
While Chen as modified discloses a sensor module connected to a waveform determination module allowing it to generate a control signal according to the body state (Segal: Some embodiments can include vibrating members, for example, that can change vibration intensities based on the flow rate of air as set forth in [0079]), it fails to explicitly disclose wherein the pharmaceutical aerosols have the particle size(s) corresponding to the modulation control signal, wherein the average size of the pharmaceutical aerosols varies according to a frequency of the modulation control signal.
However, Kelliher teaches wherein the pharmaceutical aerosols have the particle size(s) corresponding to vibration intensity (Kelliher: The frequency of vibrations can be varied depending upon the desired target size range for the resulting aerosol, mist or spray).
Chen and Kelliher are both considered to be analogous to the claimed invention because they are in the same field of drug delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Kelliher and include wherein the pharmaceutical aerosols has the particle size(s) corresponding to vibration intensity (Kelliher: The frequency of vibrations can be varied depending upon the desired target size range for the resulting aerosol, mist or spray). Doing so would mean that the particle size of the pharmaceutical aerosols would correspond to the control signal, given that the frequency of vibrations can be varied depending upon the desired target size range for the resulting aerosol, mist or spray (Kelliher: Set forth in [0056]). Given that the in view of the modification by Segal, regarding the ability of the device to change vibration intensities based on a body state, and Kelliher, regarding the frequency of vibrations particle size, above, the particle size of the pharmaceutical aerosols would correspond to the control signal, and it would mean that the average size of the pharmaceutical aerosols would vary according to a frequency of the modulation control signal.
Additionally, Given that the signal modulator (Set forth in [0084]: FIG. 8 A high-frequency vibration module 9), is configured to module the high-frequency oscillation signal by using the modulation control signal to generate a vibration signal (Set forth in [0084]: said high frequency vibration module comprises using the inverse piezoelectric effect of the piezoelectric material, converting the electric energy into mechanical vibration energy), it would mean that, provided the modifications by Segal and Kelliher, the signal modulator would performs continuous modulation of the high-frequency oscillation signal using the modulation control signal, such that the particle size of the generated pharmaceutical aerosols dynamically changes in response to the breathing state of the patient. Specifically, in Segal, FIG. 11 The detected motion thereby causes the device to awake 1108, where the device is turned on 1110 and begins operation. Additionally, some embodiments can include vibrating members, for example, that can change vibration intensities based on the flow rate of air as set forth in [0079], the vibration intensities corresponding to particle size; Kelliher: The frequency of vibrations can be varied depending upon the desired target size range for the resulting aerosol, mist or spray; the signal modulator providing continuous modulation in that it is able to operate in a manner wherein the change in vibration keeps occurring, whether it be at different frequencies, or turned completely off and then on, and the particle sizes are dynamically changing given term is being take to mean that are being changed in a usually continuous manner, according to whether the device is turned on or off, or according to the vibration intensity, which are performed according to the body state as taught by Segal).
Chen as modified fails to explicitly disclose making the porous screen press liquid medicine through a plurality of holes of the porous screen to generate the plurality of pharmaceutical aerosols according to vibration of the piezoelectric device.
However, Jackson teaches making the porous screen press liquid medicine (Jackson: The mention of medicinal efficacy indicates it could be a liquid medicine) through a plurality of holes (Jackson: FIG. 8a Mesh with a plurality of holes 51 set forth in [0080]) of the porous screen to generate the plurality of pharmaceutical aerosols according to vibration of the piezoelectric device (Jackson: When mesh vibrates the fluid from the tank passes through the plurality of holes in mesh set forth in [0080]).
Chen and Jackson are both considered to be analogous to the claimed invention because they are in the same field of atomization devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Jackson and include a porous screen configured to press liquid medicine (Jackson: The mention of medicinal efficacy indicates it could be a liquid medicine) through a plurality of holes (Jackson: FIG. 8a Mesh with a plurality of holes 51 set forth in [0080]) of the porous screen to generate the plurality of pharmaceutical aerosols according to vibration of the piezoelectric device (Jackson: When mesh vibrates the fluid from the tank passes through the plurality of holes in mesh set forth in [0080]). Doing so would allow for the atomization of liquid using a piezoelectric material (Jackson: Abstract).
Chen as modified fails to explicitly disclose, wherein the modulation control signal has a frequency of 0.05 Hz to 10 Hz or that the high-frequency oscillation signal has a frequency of 100kHz.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make modulation control signal have a frequency of 0.05 Hz to 10 Hz and the high-frequency oscillation signal have a frequency of 100kHz in the device of Chen as modified because Applicant has not disclosed that the specific frequency, is used for a particular purpose, or solves a stated problem. Specifically, the specification states in [0040] that “The modulation control signal is usually a low-frequency signal, such as a low-frequency signal of 0.05 Hz to 10 Hz, but the present disclosure is not limited thereto”, and in [0041] that “The frequency of the high- frequency oscillation signal is corresponding to the voltage level of the DC input voltage, i.e., the high-frequency oscillation circuit 15 is a voltage controlled oscillator. For example, the frequency of the high-frequency oscillation signal may be 100 kHz”. However, as explained in MPEP § 2144, subsection II, the discovery of optimum or workable ranges or values are obvious to one of ordinary skill in the art In KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007) in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Additionally, In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), it was held that it is not inventive to discover the optimum or workable ranges by routine experimentation. One of ordinary skill in the art, furthermore, would have expected modulation control signal frequency and high-frequency oscillation signal frequency of Chen as modified, and Applicant's frequencies, to perform equally well because both frequencies are used to perform the same function of generating the modulation control signal according to the body state and the auxiliary information and generate a high- frequency oscillation signal is corresponding to the voltage level of the DC input voltage for use for communication and control in the control method of the device.
Therefore, it would have been prima facie obvious to further modify Chen to obtain the invention as specified in claim 11, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired communication or control via the generated signals and thus fails to patentably distinguish over the prior art of Chen.
Regarding claim 14, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 11 above.
Chen further discloses the atomization method further comprising: using a direct current/alternative current (DC/AC) converter (AC/DC power supply adapter set forth in [0084]), to convert an AC input voltage to a DC input voltage (Inherent definition of an AC/DC adapter), so as to provide the DC input voltage to the high-frequency oscillation circuit, wherein a frequency of the high-frequency oscillation signal generated by the high-frequency oscillation circuit is corresponding to the DC input voltage (DC voltage input by the power supply module and adapter cause the phase shift circuit to function and create a phase difference in the signal as set forth in [0086] which is known in the art as a sinusoidal oscillation signal); and using a power amplifier (A power amplifying circuit included in the driving circuit set forth in [0086]), to amplify the vibration signal and output the amplified vibration signal (Inherent definition of a power amplifier) to the piezoelectric device.
Regarding claim 18, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 11 above.
Chen as modified further discloses the atomization method, further comprising: using a container (FIGS. 1-2 Storage tank 11) to accommodate the liquid medicine (Set forth in the abstract and [0028]); and using a nozzle (FIG. 1 Suction nozzle 32) to spray the plurality of the pharmaceutical aerosols (Jackson: When mesh vibrates the fluid from the tank passes through the plurality of holes in mesh set forth in [0080]).
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN 111420188 A) in view of Segal (US 20200330719 A1), in view of Kelliher (US 20070256684 A1), in view of Jackson (US 20200290077 A1) as applied to claims 1 and 11, in further view of Tobia (US 20050284469 A1).
Regarding claim 2, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Chen as modified discloses wherein the waveform determination circuit generates the modulation control signal (Set forth in [0086]: A driving circuit composed of a signal generator circuit) according to the body state (Segal: Some embodiments can include vibrating members, for example, that can change vibration intensities based on the flow rate of air as set forth in [0079]), and the body state further comprises at least one a body temperature of the patient (FIG. 2A Temperature sensor 232 set forth in [0063]).
However, Chen does not explicitly disclose the atomizer, further comprising: a transeiver, electrically connected to the waveform determination circuit, configured to obtain auxiliary information; wherein the signal modulator generates the modulation control signal according to the auxiliary information, the auxiliary information comprises at least one of a medicine drug type.
However, Tobia teaches a transeiver (Tobia: FIG. 2 Control unit 29 of nebulizer 18 set forth in [0028]), configured to obtain auxiliary information (Tobia: Several parameters are obtained by the integrated nebulizer including drug type as set forth in [0011]), wherein a signal is generated according to the auxiliary information (Tobia: A control value based upon one or more ventilatory control parameters, operating the ventilator to provide respiration therapy to a patient, and generating a modification signal from the control unit to automatically modify an operating condition of the nebulizer based upon the control value as set forth in [0010]), the auxiliary information comprises at least a medicine drug type (Tobia: Set forth in [0011]).
Chen and Tobia are both considered to be analogous to the claimed invention because they are in the same field of drug delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Tobia and include a transeiver (Tobia: FIG. 2 Control unit 29 of nebulizer 18 set forth in [0028]), electrically connected to the waveform determination circuit, configured to obtain auxiliary information (Tobia: Several parameters are obtained by the integrated nebulizer including drug type as set forth in [0011]), wherein a signal is generated according to the auxiliary information (Tobia: A control value based upon one or more ventilatory control parameters, operating the ventilator to provide respiration therapy to a patient, and generating a modification signal from the control unit to automatically modify an operating condition of the nebulizer based upon the control value as set forth in [0010]), the auxiliary information comprises at least a medicine drug type (Tobia: Set forth in [0011]). Doing so would ensure the optimization of aerosolized drug delivery by allowing for automatic adjustment of nebulization (Tobia: Set forth in [0011]).
Regarding claim 12, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 11 above.
Chen as modified discloses wherein the waveform determination circuit generates the modulation control signal (Set forth in [0086]: A driving circuit composed of a signal generator circuit) according to the body state (Segal: Some embodiments can include vibrating members, for example, that can change vibration intensities based on the flow rate of air as set forth in [0079]), and the body state further comprises at least one a body temperature of the patient (FIG. 2A Temperature sensor 232 set forth in [0063]).
However, Chen does not explicitly disclose atomization method, further comprising: using a transeiver to obtain auxiliary information; wherein the signal modulator generates the modulation control signal according to the auxiliary information, the auxiliary information comprises at least one of a medicine drug type.
However, Tobia teaches using a transeiver (Tobia: FIG. 2 Control unit 29 of nebulizer 18 set forth in [0028]), configured to obtain auxiliary information (Tobia: Several parameters are obtained by the integrated nebulizer including drug type as set forth in [0011]), wherein a signal is generated according to the auxiliary information (Tobia: A control value based upon one or more ventilatory control parameters, operating the ventilator to provide respiration therapy to a patient, and generating a modification signal from the control unit to automatically modify an operating condition of the nebulizer based upon the control value as set forth in [0010]), the auxiliary information comprises at least a medicine drug type (Tobia: Set forth in [0011]).
Chen and Tobia are both considered to be analogous to the claimed invention because they are in the same field of drug delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Tobia and include using a transeiver (Tobia: FIG. 2 Control unit 29 of nebulizer 18 set forth in [0028]) to obtain auxiliary information (Tobia: Several parameters are obtained by the integrated nebulizer including drug type as set forth in [0011]), wherein a signal is generated according to the auxiliary information (Tobia: A control value based upon one or more ventilatory control parameters, operating the ventilator to provide respiration therapy to a patient, and generating a modification signal from the control unit to automatically modify an operating condition of the nebulizer based upon the control value as set forth in [0010]), the auxiliary information comprises at least a medicine drug type (Tobia: Set forth in [0011]). Doing so would ensure the optimization of aerosolized drug delivery by allowing for automatic adjustment of nebulization (Tobia: Set forth in [0011]).
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN 111420188 A) in view of Segal (US 20200330719 A1), in view of Kelliher (US 20070256684 A1), in view of Jackson (US 20200290077 A1) as applied to claims 1 and 11, in further view of Gupta (US 20200069891 A1).
Regarding claim 3, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Chen as modified discloses the atomizer, wherein the waveform determination circuit generates the modulation control signal (Set forth in [0086]: A driving circuit composed of a signal generator circuit).
Chen fails to explicitly disclose the atomizer, further comprising: a manual switch, electrically connected to the waveform determination circuit, configured to generate a switch control signal according to manipulation of the patient or a manipulator, wherein the waveform determination circuit generates the modulation control signal according to the switch control signal.
However, Gupta teaches a manual switch (Gupta: A user input device such as a switch set forth in [0058]), electrically connected to circuitry of the device (Gupta: FIG. 3 Processing circuit 170 set forth in [0058]), configured to generate a switch control signal (Gupta: Trigger signal set forth in [0058]) according to manipulation of the patient or a manipulator, wherein the circuitry component generates the control signal (Gupta: FIG. 3 Processing circuit 170 generates a flow signal and transmits the flow signal to the flow controller 190 to cause the flow controller 190 to operate) according to the switch control signal.
Chen and Gupta are both considered to be analogous to the claimed invention because they are in the same field of atomization devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Gupta and include a manual switch (Gupta: A user input device such as a switch set forth in [0058]), electrically connected to circuitry of the device (Gupta: FIG. 3 Processing circuit 170 set forth in [0058]), configured to generate a switch control signal (Gupta: Trigger signal set forth in [0058]) according to manipulation of the patient or a manipulator, wherein the circuitry component generates the control signal (Gupta: FIG. 3 Processing circuit 170 generates a flow signal and transmits the flow signal to the flow controller 190 to cause the flow controller 190 to operate) according to the switch control signal. In the Chen device, the switch would be connected to the waveform determination circuit and generate the modulation control signal according to the switch control signal. Doing so would allow for the device to be switched on and off for use.
Regarding claim 13, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 11 above.
Chen as modified discloses the atomization method, wherein the waveform determination circuit generates the modulation control signal (Set forth in [0086]: A driving circuit composed of a signal generator circuit).
Chen fails to explicitly disclose the atomization method, further comprising: using a manual switch to generate a switch control signal according to manipulation of the patient or a manipulator, wherein the waveform determination circuit generates the modulation control signal according to the switch control signal.
However, Gupta teaches using a manual switch (Gupta: A user input device such as a switch set forth in [0058]) to generate a switch control signal (Gupta: Trigger signal set forth in [0058]) according to manipulation of the patient or a manipulator, wherein the circuitry component generates the control signal (Gupta: FIG. 3 Processing circuit 170 generates a flow signal and transmits the flow signal to the flow controller 190 to cause the flow controller 190 to operate) according to the switch control signal.
Chen and Gupta are both considered to be analogous to the claimed invention because they are in the same field of atomization devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Gupta and include using a manual switch (Gupta: A user input device such as a switch set forth in [0058]) to generate a switch control signal (Gupta: Trigger signal set forth in [0058]) according to manipulation of the patient or a manipulator, wherein the circuitry component generates the control signal (Gupta: FIG. 3 Processing circuit 170 generates a flow signal and transmits the flow signal to the flow controller 190 to cause the flow controller 190 to operate) according to the switch control signal. In the Chen device, the switch would be connected to the waveform determination circuit and generate the modulation control signal according to the switch control signal. Doing so would allow for the device to be switched on and off for use.
Claims 5-6 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN 111420188 A) in view of Segal (US 20200330719 A1), in view of Kelliher (US 20070256684 A1), in view of Jackson (US 20200290077 A1) as applied to claims 1 and 11, in further view of Carothers (CA 3029651 A1) and Brumfield (US 20180078212 A1).
Regarding claim 5, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Chen as modified discloses the atomizer, wherein the waveform determination circuit (The signal generator circuit set forth in [0086]) is electrically connected to the sensor module (set forth in modified Chen set forth for claim 1, the sensor module of Segal: FIG. 1A-B, 2A, 7A-B, 8, and 10 Nebulizer monitoring system 100 set forth in [0095]), and is configured to generate the modulation control signal (The signal generator circuit is the core of driving circuit used for signal set forth in [0086]).
Chen does not explicitly disclose wherein the waveform determination circuit comprises: a signal filtering circuit, electrically connected to the sensor module, configured to perform noise filtering process on a sensing signal of the body state.
However, Carothers teaches a signal filtering circuit (Carothers: FIG. 3 Processing unit 260 includes electronic filtering algorithms to reduce noise in the signals from the sensing module 250 as set forth in [0074]), electrically connected to the sensor module (Carothers: FIG. 3 Sensing module 250 as set forth in [0074])), configured to perform noise filtering process on a sensing signal of the body state (Carothers: Sensors are optical sensors capable of obtaining information regarding the air passing through the device set forth in [0071]).
Chen and Carothers are both considered to be analogous to the claimed invention because they are in the same field of drug delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Carothers and include a signal filtering circuit (Carothers: FIG. 3 Processing unit 260 includes electronic filtering algorithms to reduce noise in the signals from the sensing module 250 as set forth in [0074]), electrically connected to the sensor module (Carothers: FIG. 3 Sensing module 250 as set forth in [0074])), configured to perform noise filtering process on a sensing signal of the body state (Carothers: Sensors are optical sensors capable of obtaining information regarding the air passing through the device set forth in [0071]). Doing so would increase signal quality (Carothers: As set forth in [0074]).
Chen does not explicitly disclose wherein the waveform determination circuit comprises: a nueral network processing circuit, electrically connected to the signal filtering circuit, configured to calculate a waveform pattern according to the sensing signal on which the noise filtering process is performed.
However, Brumfield teaches a nueral network processing circuit (Brumfield: FIG. 25 Processor 302 set forth in the claim 1, [0082], and [0089]), electrically connected to the signal filtering circuit (Brumfield: FIG. 25 Sensor 311 set forth in [0083]), configured to calculate a waveform pattern according to the sensing signal (Brumfield: FIG. 25 Sensor 311 data to compute a waveform set forth in the abstract, [008], and claim 1).
Chen and Brumfield are both considered to be analogous to the claimed invention because they are in the same field of respiratory health devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Brumfield and include a nueral network processing circuit (Brumfield: FIG. 25 Processor 302 set forth in the claim 1, [0082], and [0089]), electrically connected to the signal filtering circuit (Brumfield: FIG. 25 Sensor 311 set forth in [0083]), configured to calculate a waveform pattern according to the sensing signal (Brumfield: FIG. 25 Sensor 311 data to compute a waveform set forth in the abstract, [008], and claim 1) on which the noise filtering process is performed. Doing so would enable the device to calculate a waveform reflective of a body state (Brumfield: Set forth in the abstract) to be used to generate a modulation control signal.
Chen as modified does not explicitly disclose wherein the waveform determination circuit comprises: a modulation control signal generation module, electrically connected to the nueral network processing circuit and the signal modulator, configured to generate the modulation control signal according to the calculated waveform pattern.
However, the waveform determination circuit of Chen (The signal generator circuit set forth in [0086]) as modified, comprising the nueral network processing circuit (Brumfield: FIG. 25 Processor 302 set forth in the claim 1, [0082], and [0089]) and electrically connected to the signal modulator (FIG. 8 shows the high-frequency vibration module 9 and the ultrasonic motor 101 driving circuit are connected. FIG. 9 is the driving circuit composed of the signal generator circuit and the phase shift circuit set forth in [0086]), acts as a modulation control signal generation module configured to generate the modulation control signal (The signal generator circuit is the core of driving circuit used for signal set forth in [0086]) according to the calculated waveform pattern.
Regarding claim 6, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 5 above.
Chen as modified discloses the atomizer, wherein the nueral network processing circuit (Brumfield: FIG. 25 Processor 302 set forth in the claim 1, [0082], and [0089]) calculates a waveform pattern according to the sensing signal on which the noise filtering process is performed.
Chen as modified by Brumfield is silent as to whether or not the nueral network processing circuit comprises a neural network based classifier, and that the neural network based classifier is configured to calculate a waveform pattern.
However, the core computing element of modified Chen performs the identical function specified in the claim in substantially the same way, and produces substantially the same results as the corresponding element disclosed in the specification. See in Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364, 54 USPQ2d 1308, 1315 (Fed. Cir. 2000) and Odetics Inc. v. Storage Tech. Corp., 185 F.3d 1259, 1267, 51 USPQ2d 1225, 1229-30 (Fed. Cir. 1999); Lockheed Aircraft Corp. v. United States, 193 USPQ 449, 461 (Ct. Cl. 1977), see also MPEP § 2183. The concepts of equivalents as set forth in Graver Tank & Mfg. Co. v. Linde Air Products, 339 U.S. 605, 85 USPQ 328 (1950) are relevant to any "equivalents" determination. Both the core computing element of modified Chen and the element claimed by Applicant are configured to calculate a waveform. Additionally, A person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. Both would result in the same completion of the same function, calculating a waveform. See in Caterpillar Inc. v. Deere & Co., 224 F.3d 1374, 56 USPQ2d 1305 (Fed. Cir. 2000); Al-Site Corp. v. VSI Int’ l, Inc., 174 F.3d 1308, 1316, 50 USPQ2d 1161, 1165 (Fed. Cir. 1999).
Therefore, it would have been prima facie obvious to modify Chen as modified to obtain the invention as specified in claim 6 because such a modification is considered to be well within the skill level of the ordinary artisan since they are equivalents and thus fails to patentably distinguish over the prior art of Chen as modified.
Regarding claim 15, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 11 above.
Chen as modified discloses the atomization method, wherein the step of using the waveform determination circuit (The signal generator circuit set forth in [0086]) generates the modulation control signal (The signal generator circuit is the core of driving circuit used for signal set forth in [0086]).
Chen does not explicitly disclose wherein the step of using the waveform determination circuit comprises: using a signal filtering circuit, to perform a noise filtering process on a sensing signal of the body state.
However, Carothers teaches using a signal filtering circuit (Carothers: FIG. 3 Processing unit 260 includes electronic filtering algorithms to reduce noise in the signals from the sensing module 250 as set forth in [0074]) to perform a noise filtering process on a sensing signal of the body state (Carothers: Sensors are optical sensors capable of obtaining information regarding the air passing through the device set forth in [0071]).
Chen and Carothers are both considered to be analogous to the claimed invention because they are in the same field of drug delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Carothers and include using a signal filtering circuit (Carothers: FIG. 3 Processing unit 260 includes electronic filtering algorithms to reduce noise in the signals from the sensing module 250 as set forth in [0074]) to perform a noise filtering process on a sensing signal of the body state (Carothers: Sensors are optical sensors capable of obtaining information regarding the air passing through the device set forth in [0071]). Doing so would increase signal quality (Carothers: As set forth in [0074]).
Chen does not explicitly disclose wherein the step of using the waveform determination circuit comprises: using a nueral network processing circuit to calculate a waveform pattern according to the sensing signal on which the noise filtering process is performed.
However, Brumfield teaches using a nueral network processing circuit (Brumfield: FIG. 25 Processor 302 set forth in the claim 1, [0082], and [0089]) to calculate a waveform pattern according to the sensing signal (Brumfield: FIG. 25 Sensor 311 data to compute a waveform set forth in the abstract, [008], and claim 1).
Chen and Brumfield are both considered to be analogous to the claimed invention because they are in the same field of respiratory health devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Brumfield and include using a nueral network processing circuit (Brumfield: FIG. 25 Processor 302 set forth in the claim 1, [0082], and [0089]) to calculate a waveform pattern according to the sensing signal (Brumfield: FIG. 25 Sensor 311 data to compute a waveform set forth in the abstract, [008], and claim 1). Doing so would enable the device to calculate a waveform reflective of a body state (Brumfield: Set forth in the abstract) to be used to generate a modulation control signal.
Chen as modified does not explicitly disclose wherein the step of using the waveform determination circuit comprises: using a modulation control signal generation module to generate the modulation control signal according to the calculated waveform pattern.
However, the step of using the waveform determination circuit of Chen (The signal generator circuit set forth in [0086]) as modified, comprising using the nueral network processing circuit (Brumfield: FIG. 25 Processor 302 set forth in the claim 1, [0082], and [0089]) acts as a modulation control signal generation module to generate the modulation control signal (The signal generator circuit is the core of driving circuit used for signal set forth in [0086]) according to the calculated waveform pattern.
Regarding claim 16, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 15 above.
Chen as modified discloses atomization method, wherein the nueral network processing circuit (Brumfield: FIG. 25 Processor 302 set forth in the claim 1, [0082], and [0089]) calculates a waveform pattern according to the sensing signal on which the noise filtering process is performed.
Chen as modified by Brumfield is silent as to whether or not the nueral network processing circuit comprises a neural network based classifier, and that the neural network based classifier is configured to calculate a waveform pattern.
However, core computing element of modified Chen performs the identical function specified in the claim in substantially the same way, and produces substantially the same results as the corresponding element disclosed in the specification. See in Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364, 54 USPQ2d 1308, 1315 (Fed. Cir. 2000) and Odetics Inc. v. Storage Tech. Corp., 185 F.3d 1259, 1267, 51 USPQ2d 1225, 1229-30 (Fed. Cir. 1999); Lockheed Aircraft Corp. v. United States, 193 USPQ 449, 461 (Ct. Cl. 1977), see also MPEP § 2183. The concepts of equivalents as set forth in Graver Tank & Mfg. Co. v. Linde Air Products, 339 U.S. 605, 85 USPQ 328 (1950) are relevant to any "equivalents" determination. Both the core computing element of modified Chen and the element claimed by Applicant are configured to calculate a waveform. Additionally, A person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. Both would result in the same completion of the same function, calculating a waveform. See in Caterpillar Inc. v. Deere & Co., 224 F.3d 1374, 56 USPQ2d 1305 (Fed. Cir. 2000); Al-Site Corp. v. VSI Int’ l, Inc., 174 F.3d 1308, 1316, 50 USPQ2d 1161, 1165 (Fed. Cir. 1999).
Therefore, it would have been prima facie obvious to modify Chen as modified to obtain the invention as specified in claim 16 because such a modification is considered to be well within the skill level of the ordinary artisan since they are equivalents and thus fails to patentably distinguish over the prior art of Chen as modified.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN 111420188 A) in view of Segal (US 20200330719 A1), in view of Kelliher (US 20070256684 A1), in view of Jackson (US 20200290077 A1) as applied to claims 1 and 11, in further view of Freeman (US 20220095695 A1).
Regarding claim 7, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Chen as modified does not explicitly disclose the atomizer, wherein the sensor module comprises a microphone module.
However, Freeman teaches wherein the sensor module (Freeman: FIG. 4 Volume flow sensor 422) comprises a microphone module (Freeman: The flow sensor can be a microphone as set forth in [0045]).
Chen and Freeman are both considered to be analogous to the claimed invention because they are in the same field of inhalation devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Freeman and include wherein the sensor module (Freeman: FIG. 4 Volume flow sensor 422) comprises a microphone module (Freeman: The flow sensor can be a microphone as set forth in [0045]). Doing so would mean the microphone could be setup to listen to the noise of the air mixture passing through the device, where the sound intensity correlates with the flow rate, allowing the sensor to obtain relevant data regarding the body state of the user (Freeman: Set forth in [0045]).
Regarding claim 17, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 11 above.
Chen as modified does not explicitly disclose the atomization method, wherein the sensor module comprises a microphone module.
However, Freeman teaches wherein the sensor module (Freeman: FIG. 4 Volume flow sensor 422) comprises a microphone module (Freeman: The flow sensor can be a microphone as set forth in [0045]).
Chen and Freeman are both considered to be analogous to the claimed invention because they are in the same field of inhalation devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Freeman and include wherein the sensor module (Freeman: FIG. 4 Volume flow sensor 422) comprises a microphone module (Freeman: The flow sensor can be a microphone as set forth in [0045]). Doing so would mean the microphone could be setup to listen to the noise of the air mixture passing through the device, where the sound intensity correlates with the flow rate, allowing the sensor to obtain relevant data regarding the body state of the user (Freeman: Set forth in [0045]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN 111420188 A) in view of Segal (US 20200330719 A1), in view of Kelliher (US 20070256684 A1), in view of Jackson (US 20200290077 A1) as applied to claim 1, in further view of Cheng (US 20180065160 A1).
Regarding claim 8, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Chen as modified discloses the atomizer, further comprising: a container (FIGS. 1-2 Storage tank 11), configured to accommodate the liquid medicine (Set forth in the abstract and [0028]); and holes Jackson: FIG. 8a Mesh with a plurality of holes 51 set forth in [0080]), and a nozzle (FIG. 1 Suction nozzle 32) configured to spray the plurality of the pharmaceutical aerosols (Jackson: When mesh vibrates the fluid from the tank passes through the plurality of holes in mesh set forth in [0080]).
Chen does not explicitly disclose the nozzle, disposed on an outer surface of the container and is silent regarding whether the nozzle is arranged corresponding to the holes.
However, Cheng teaches the nozzle (Cheng: FIG.1 Nozzle portion 122) disposed on an outer surface of the container (Cheng: FIG.1 Container portion 120 containing the liquid medicine set forth in [0035], the container portion 120 includes a port 1200 to communicate with the nozzle portion 122) and arranged corresponding to the holes of the piezoelectric device (Cheng: FIG. 1 Atomizer A1, can be a piezoelectric plate set forth in [0020], with a plurality of holes, the pores set forth in [0037]).
Chen and Cheng are both considered to be analogous to the claimed invention because they are in the same field of inhalation devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Cheng and include where the nozzle (Cheng: FIG.1 Nozzle portion 122) disposed on an outer surface of the container (Cheng: FIG.1 Container portion 120 containing the liquid medicine set forth in [0035], the container portion 120 includes a port 1200 to communicate with the nozzle portion 122) and arranged corresponding to the holes of the piezoelectric device (Cheng: FIG. 1 Atomizer A1, can be a piezoelectric plate set forth in [0020], with a plurality of holes, the pores set forth in [0037]). Doing so allows the nozzle portion to communicate directly with the container portion containing the liquid medicine, provided with an atomizer disposed therein, in order to provide the user with treatment (Set forth in [0006]).
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN 111420188 A) in view of Segal (US 20200330719 A1), in view of Kelliher (US 20070256684 A1), in view of Jackson (US 20200290077 A1) as applied to claims 1 and 11, in further view of Klemm (CN 111867656 A) and Carothers (CA 3029651 A1)
Regarding claim 9, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Chen as modified discloses the atomizer comprising a signal modulator (Set forth in [0084]: FIG. 8 A high-frequency vibration module 9).
Chen as modified does not explicitly disclose wherein the signal modulator comprises: a mixer, electrically connected to the high-frequency oscillation circuit and the waveform determination circuit, configured to mix the modulation control signal and the high-frequency oscillation signal to generate a mixed signal.
However, Klemm teaches a mixer (Klemm: FIG. 4 A mixer is used in the signal detector 124 and signal generator 122, where two oscillators are connected as set forth in [00166] of the machine translation with labeled paragraphs, configured to generate a mixed signal (Klemm: An output signal of the mixer is produced as set forth in [00166]).
Chen and Klemm are both considered to be analogous to the claimed invention because they are in the same field of drug delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Klemm and include a mixer (Klemm: FIG. 4 A mixer is used in the signal detector 124 and signal generator 122, where two oscillators are connected as set forth in [00166] of the machine translation with labeled paragraphs), electrically connected to the high-frequency oscillation circuit and the waveform determination circuit, configured to mix the modulation control signal and the high-frequency oscillation signal to generate a mixed signal (Klemm: An output signal of the mixer is produced as set forth in [00166]). Doing so enables the signal modulator to use both signals to create one output signal (Klemm: As set forth in [00166]) and in this case, generate a vibration signal.
Chen as modified does not explicitly disclose wherein the signal modulator comprises: a filter module filter module, electrically connected to the mixer and the piezoelectric device, configured to perform an intermediate frequency filtering process on the mixed signal to generate the vibration signal.
However, Carothers teaches a filter module (Carothers: FIG. 3 Processing unit 260 as set forth in [0074]), configured to perform an intermediate frequency filtering process (Carothers: Filtering algorithms reduce noise in signals as set forth in [0074]) to generate a signal.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Carothers and include a filter module (Carothers: FIG. 3 Processing unit 260 as set forth in [0074]), electrically connected to the mixer and the piezoelectric device, configured to perform an intermediate frequency filtering process (Carothers: Filtering algorithms reduce noise in signals as set forth in [0074]) on the mixed signal to generate the vibration signal. Doing so would increase the signal quality (Carothers: As set forth in [0074]) of the vibration signal generated.
Regarding claim 19, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 11 above.
Chen as modified discloses the atomization method using the signal modulator (Set forth in [0084]: FIG. 8 A high-frequency vibration module 9) to module the high-frequency oscillation signal (Created by what is set forth in [0086]: A driving circuit composed of a phase shift circuit) by using the modulation control signal to generate the vibration signal (Vibration is driven by the high-frequency vibration module set forth in [0085]).
Chen as modified does not explicitly disclose wherein the steps of using the signal modulator comprises: using a mixer, electrically connected to the high-frequency oscillation circuit and the waveform determination circuit, configured to mix the modulation control signal and the high-frequency oscillation signal to generate a mixed signal.
However, Klemm teaches using a mixer (Klemm: FIG. 4 A mixer is used in the signal detector 124 and signal generator 122, where two oscillators are connected as set forth in [00166] of the machine translation with labeled paragraphs, configured to generate a mixed signal (Klemm: An output signal of the mixer is produced as set forth in [00166]).
Chen and Klemm are both considered to be analogous to the claimed invention because they are in the same field of drug delivery devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Klemm and include using a mixer (Klemm: FIG. 4 A mixer is used in the signal detector 124 and signal generator 122, where two oscillators are connected as set forth in [00166] of the machine translation with labeled paragraphs) to mix the modulation control signal and the high-frequency oscillation signal to generate a mixed signal (Klemm: An output signal of the mixer is produced as set forth in [00166]). Doing so enables the signal modulator to use both signals to create one output signal (Klemm: As set forth in [00166]) and in this case, generate a vibration signal.
Chen as modified does not explicitly disclose wherein the signal modulator comprises: using a filter module filter module to perform an intermediate frequency filtering process on the mixed signal to generate the vibration signal.
However, Carothers teaches using a filter module (Carothers: FIG. 3 Processing unit 260 as set forth in [0074]) to perform an intermediate frequency filtering process (Carothers: Filtering algorithms reduce noise in signals as set forth in [0074]) to generate a signal.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Carothers and include using a filter module (Carothers: FIG. 3 Processing unit 260 as set forth in [0074]), electrically connected to the mixer and the piezoelectric device, configured to perform an intermediate frequency filtering process (Carothers: Filtering algorithms reduce noise in signals as set forth in [0074]) on the mixed signal to generate the vibration signal. Doing so would increase the signal quality (Carothers: As set forth in [0074]) of the vibration signal generated.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN 111420188 A) in view of Segal (US 20200330719 A1), in view of Kelliher (US 20070256684 A1), in view of Jackson (US 20200290077 A1) as applied to claims 1 and 11, in further view of Bybordi (CA 2985942 A1).
Regarding claim 10, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Chen as modified is silent as to whether the modulation control signal is one or combination of a square wave, a triangle wave and a sinuous wave.
However, Bybordi teaches wherein a modulation control signal is a square wave (Bybordi: As set forth in [0129]).
Chen and Bybordi are both considered to be analogous to the claimed invention because they are in the same field of medical devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Bybordi and include where a modulation control signal is a square wave (Bybordi: As set forth in [0129]). Doing so provides a pulse signal (Bybordi: Set forth in [0129]) in order to be able to generate the vibration signal.
Regarding claim 20, Chen as modified discloses the claimed invention substantially as claimed as set forth for claim 11 above.
Chen as modified is silent as to whether the modulation control signal is one or combination of a square wave, a triangle wave and a sinuous wave.
However, Bybordi teaches wherein a modulation control signal is a square wave (Bybordi: As set forth in [0129]).
Chen and Bybordi are both considered to be analogous to the claimed invention because they are in the same field of medical devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Chen to incorporate the teaching of Bybordi and include where a modulation control signal is a square wave (Bybordi: As set forth in [0129]). Doing so provides a pulse signal (Bybordi: Set forth in [0129]) in order to be able to generate the vibration signal.
Response to Arguments
The rejections under 35 U.S.C. 112(f), 35 U.S.C. 112(a) and 35 U.S.C. 112(b) regarding claims 1-20 have been withdrawn based on Applicant’s amendments.
Applicant's arguments filed 02/09/2026 have been fully considered but they are not persuasive.
Applicant argues tat the combination fails to disclose the amended feature of “dynamic particle size adaptive control”.
However, it is noted that it is noted that the features upon which applicant relies (i.e., the term: “dynamic particle size adaptive control”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Nonetheless, given the lack of description regarding the amended limitations, specifically, the limitations “continuous” first recited in line 21 of claim 1 which is not defined by the specification and the limitation “dynamically changes” first recited in line 23 of claim 1 is not explicitly defined or specified by the specification, the limitations are reasonably understood according to their plain meaning. The limitation “continuous” is reasonably understood according to its plain meaning as being able perform in a way that keeps occurring, and the limitation “dynamically changes” first recited in line 23 of claim 1 is reasonably understood according to its plain meaning as a “usually continuous change”, both of which are described in terms of how they appl to the references applied above for independent claims 1 and 11.
New grounds of rejection are made above to address the amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEIRA EILEEN CALLISON whose telephone number is (571)272-0745. The examiner can normally be reached Monday-Friday 7:30-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KEIRA EILEEN CALLISON/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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