DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Preliminary Amendment
This Office Action is in response to the preliminary amendment filed on 04/15/2023. Per the amendment claims 1-15 are canceled and claims 16-32 are new. As such, claims 16-32 are pending in the instant application.
Information Disclosure Statement
The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the controller (claim 1, line 7) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 16-17, 21-23, 27, and 31-32 are objected to because of the following informalities:
Claims 16 and 27: “ the amplitude” should read “an amplitude” to establish antecedent basis.
Claims 16 and 27: “the basis” should read “a basis” to establish antecedent basis.
Claim 17, line 2: “the infrared region” should read “an infrared region” to establish antecedent basis.
Claims 21 and 31: “and / or” should read “and/or”.
Claims 22 & 32: “the velocity” should read “a velocity” to establish antecedent basis.
Claim 23, line 2: “the flow rate of the air” should read “a flow rate of air” to establish antecedent basis.
Claim 27, lines 3, 4, and 6: “a” or “an” should read “the” for consistency and clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-26, 28, and 30-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitation "the sensor" in line 10. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the sensor is referring to the optical sensor disclosed in line 6 of claim 1, or if Applicant is attempting to disclose a new limitation. For the purpose of examination, the sensor will be interpreted as – the optical sensor.
Claim 21 recites the limitation “on the basis of the demodulated output signal” in line 5. It is unclear if the demodulated output signal is a recitation of the demodulated output signal disclosed in claim 16 (lines 11-12), or is a recitation of the output signal that was demodulated at a scanning frequency as disclosed in claim 21 (lines 3-4). For the purpose of examination, the limitation above will be interpreted as – on a basis of the output signal demodulated at a scanning frequency that corresponds to the period between scans.
Regarding claim 28, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of examination, the limitation “such as about 10 Hz” recited in claim 28 (line 2) will be interpreted as part of the claimed invention.
Claim 30 recites “[T]he method according to claim 26”; however, claim 26 does not disclose a method as claim 26 recites “[T]he inhalation device according to claim 16, wherein the channel is part of a component that is removable from the rest of the device.” It is unclear if claim 30 depends on claim 26 or if this is a typo. For the purpose of examination, claim 30 will be interpreted as depending on claim 27 as best understood by the Examiner in light of the specification.
Claim 31 recites the limitation “on the basis of the demodulated output signal” in lines 4-5. It is unclear if the demodulated output signal is a recitation of the demodulated output signal disclosed in claim 27 (lines 6-9), or is a recitation of the output signal that was demodulated at a scanning frequency as disclosed in claim 31 (line 3). For the purpose of examination, the limitation above will be interpreted as – on a basis of the output signal demodulated at the scanning frequency.
Claims 27-26 are rejected due to dependency on a rejected claim.
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.
Claims 16-21 & 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Feiner & Borgschulte (US 20060102178 A1) hereinafter Feiner, in view of Wilkerson et al. (US 20140151457 A1) hereinafter Wilkerson, in further view of Sommer et al. (DE 10022795 A1) hereinafter Sommer.
Regarding claim 16, Feiner discloses an inhalation device (Fig. 3) comprising:
a channel (5; Fig. 3) having an air inlet opening (inlet opening 52 is received in, see Annotated Fig. 3 below) and an aerosol outlet opening (mouthpiece 5 outlet opening, see Annotated Fig. 3 below),
an aerosol generator (membrane nebulizer 52, chamber retaining 55, see Annotated Fig. 3 below) comprising a vibrator (54; Fig. 3) and a membrane (53; Fig. 3),
a reservoir for liquid to be aerosolized (chamber retaining 55, see Annotated Fig. 3 below, where 55 is the liquid to be nebulized, [0016]) which is fluidically connected to the membrane ([0016]),
an optical sensor (infrared transmitting means 7, first receiving means 8; Figs. 2 and 3; [0018]) for detecting the presence of aerosol within the channel ([0030]),
a controller (10; Fig. 3) which is configured (i) to provide a driver signal (signals from controller 10 to operate excitation device 56; Fig. 3; [0029]) to operate the vibrator so that the membrane vibrates (controller 10 operates and controls excitation device 56, where excitation device 56 is the activation means of piezo element 54, where the activation of piezo element 54 vibrates membrane 53; [0029] and [0016]) and generates an aerosol in the channel (liquid 55 is nebulized by the vibration of membrane 53; [0016]); (ii) to receive an output signal from the sensor (controller 10 receives output signal from first receiving means 8 of the optical sensor, [0018]); and (iii) to determine whether aerosol is present in the channel (determination of whether aerosol is present in the mouthpiece 5 on the basis of the outputs signal from first receiving means 8 of the optical sensor, [0021], [0025], [0026]).
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Feiner fails to explicitly disclose a controller (10; Fig. 3) which is configured (i) to provide a driver signal (signals from controller 10 to operate excitation device 56; Fig. 3; [0029]) to operate the vibrator so that the membrane vibrates (controller 10 operates and controls excitation device 56, where excitation device 56 is the activation means of piezo element 54, where the activation of piezo element 54 vibrates membrane 53; [0029] and [0016]) and generates an aerosol in the channel (liquid 55 is nebulized by the vibration of membrane 53; [0016]), and to modulate the amplitude of the driver signal at a frequency of from 1 to 100 Hz; (ii) to receive an output signal from the sensor (controller 10 receives output signal from first receiving means 8 of the optical sensor, [0018]) and to demodulate the output signal; (iii) to determine whether aerosol is present in the channel on the basis of the demodulated output signal (determination of whether aerosol is present in the mouthpiece 5 on the basis of the outputs signal from first receiving means 8 of the optical sensor, [0021], [0025], [0026]); and (iv) to stop operating the vibrator if it determines that no aerosol is present.
However, Wilkerson teaches a piezoelectric ejector assembly including a piezoelectric actuator with a drive signal (excitation signal of the piezoelectric actuator, [0152]), where the amplitude of the drive signal (amplitude of excitation signal of the piezoelectric actuator, [0152]) is modulated with a sinusoidal wave (sinusoidal excitation of the piezoelectric actuator, [0152]; [0068]; [0093]; [0180]), where the modulated drive signal may range from 1 Hz to 10 MHz (drive frequency may range from 1 Hz to 10 MHz, [0126]). Wilkerson further teaches the demodulation of an output signal (the output signal from the piezoelectric actuator is applied to an analog energy integrator to produce the original message signal, [0093]; [0125]; demodulation of output signal from an infrared phototransistor, [0218]) to detect a spray volume. Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Feiner with Wilkerson such that the controller (10; Fig. 3) is configured to (i) modulate the amplitude of the driver signal at a frequency of from 1 to 100 Hz (signals from controller 10 to operate excitation device 56 modulated with sinusoidal wave to a drive frequency of 1 Hz to 10 MHz as taught by Wilkerson; Wilkerson: [0152]; [0068]; [0093]; [0180]; [0126]; Examiner Note: the amplitude modulation range of 1 Hz to 10 MHz as taught by Wilkerson includes the invention’s disclosed amplitude modulation range of 1 Hz to 100 Hz, hence it would have been recognized, by a person of ordinary skill in the art, as an obvious try to select an amplitude modulation range of a drive signal from 1 Hz to 100 Hz as there are a finite number of identified and predictable solutions, and a person of ordinary skill has good reason to pursue the known options within his or her technical grasp, see MPEP §2144.05), (ii) to demodulate the output signal (demodulate output signals from receiving means 8 of optical sensor, where the demodulation of an output signal for analysis is taught by Wilkerson, [0093], [0125], [0218]), and (iii) to determine whether aerosol is present in the channel on the basis of the demodulated output signal (determination of whether aerosol is present in the mouthpiece 5 on the basis of the output signal from first receiving means 8 of the optical sensor, [0021], [0025], [0026]; Where the output signal from first receiving means 8 of the optical sensor is demodulated as taught by Wilkerson, see above) to improve accuracy of real-time calculations and analysis (Wilkerson: [0140]).
Feiner in view of Wilkerson fails to explicitly disclose the controller (10; Fig. 3) which is configured (iv) to stop operating the vibrator if it determines that no aerosol is present. However, Feiner does teach the control method described in Sommer can be carried out based on the output signal of first receiving means (8; Fig. 3; [0029]), where Sommer teaches a control unit (9) controls an excitation device (56) based on an output signal of a receiver (8) of an optical sensor (transmitter 7 and receiver 8; [0064], see provided translation). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Feiner as modified to explicitly teach the controller (10; Fig. 3) which is configured (iv) to stop operating the vibrator if it determines that no aerosol is present (Sommer: [0064], see provided translation) to prevent waste of produced aerosol (Sommer: [0003], see provided translation).
Regarding claim 17, Feiner as modified teaches the invention as set forth in claim 16, wherein the optical sensor operates in the infrared region (infrared transmitting means 7, first receiving means 8, second receiving means 9; Figs. 2 and 3; [0018]).
Regarding claim 18, Feiner as modified teaches the invention as set forth in claim 16, wherein the optical sensor (infrared transmitting means 7, first receiving means 8, second receiving means 9; Figs. 2 and 3; [0018]) comprises an emitter (infrared transmitting means 7; Fig. 3; [0018]) and a detector (first receiving means 8; Fig. 3) that are arranged on opposite sides of the channel (7 and 8 are arranged on opposite sides of 5, see Fig. 2).
Regarding claim 19, Feiner as modified teaches the invention as set forth in claim 16, wherein the controller (10; Fig. 3) is configured to modulate the amplitude of the driver signal at a frequency of from 5 to 40 Hz (signals from controller 10 to operate excitation device 56 modulated with sinusoidal wave to a drive frequency of 1 Hz to 10 MHz as taught by Wilkerson; Wilkerson: [0152]; [0068]; [0093]; [0180]; [0126]; see claim 16 above; Examiner Note: the amplitude modulation range of 1 Hz to 10 MHz as taught by Wilkerson includes the invention’s disclosed amplitude modulation frequency of from 5 Hz to 40 Hz, hence it would have been recognized, by a person of ordinary skill in the art, as an obvious try to modulate the drive signal at a frequency of from 5 Hz to 40 Hz, as there are a finite number of identified and predictable solutions, and a person of ordinary skill has good reason to pursue the known options within his or her technical grasp, see MPEP §2144.05).
Regarding claim 20, Feiner as modified teaches the invention as set forth in claim 16, wherein the controller (10; Fig. 3) is configured to modulate the amplitude of the driver signal at a frequency of about 10 Hz (signals from controller 10 to operate excitation device 56 modulated with sinusoidal wave to a drive frequency of 1 Hz to 10 MHz as taught by Wilkerson; Wilkerson: [0152]; [0068]; [0093]; [0180]; [0126]; see claim 16 above; Examiner Note: the amplitude modulation range of 1 Hz to 10 MHz as taught by Wilkerson includes the invention’s disclosed amplitude modulation frequency of about 10 Hz, hence it would have been recognized, by a person of ordinary skill in the art, as an obvious try to modulate the drive signal at a frequency of about 10 Hz, as there are a finite number of identified and predictable solutions, and a person of ordinary skill has good reason to pursue the known options within his or her technical grasp, see MPEP §2144.05).
Regarding claim 21, Feiner as modified teaches the invention as set forth in claim 16, but does not explicitly teach wherein the controller (10; Fig. 3) is configured (i) to periodically perform a scan to determine a resonant frequency of the aerosol generator and/or the membrane; (ii) to demodulate the output signal at a scanning frequency that corresponds to the period between scans; and (iii) to determine whether aerosol is present in the channel on the basis of the demodulated output signal.
However, Wilkerson teaches a method to determine a resonance frequency of a piezoelectric actuator (Fig. 20), where periodic scans are performed to determine a resonant frequency of the piezoelectric actuator (Fig. 20; [0134]), demodulation of the output signal at a scanning frequency that corresponds to the period between scans ([0093], where the electrical signal applied for a defined amount of time and then stopped suddenly is the drive signal 530, and this process is depicted in steps 2000 to 2020 of Fig. 20; [0125], lines 11 to then end of the paragraph). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Feiner with Wilkerson such that the controller (10; Fig. 3) is configured (i) to periodically perform a scan to determine a resonant frequency of the aerosol generator and/or the membrane (Wilkerson: Fig. 20; [0134]); (ii) to demodulate the output signal at a scanning frequency that corresponds to the period between scans ([0093], where the electrical signal applied for a defined amount of time and then stopped suddenly is the drive signal 530, and this process is depicted in steps 2000 to 2020 of Fig. 20; [0125], lines 11 to then end of the paragraph); and (iii) to determine whether aerosol is present in the channel on the basis of the demodulated output signal (determination of whether aerosol is present in the mouthpiece 5 on the basis of the output signal from first receiving means 8 of the optical sensor, [0021], [0025], [0026]; Where the output signal from first receiving means 8 of the optical sensor is demodulated as taught by Wilkerson, see (ii) in claim 21 above) to provide feedback and improve the control and accuracy of the demodulation of the output signal (Wilkerson: [0125], last sentence).
Regarding claim 27, Feiner as modified teaches a method of operating an inhalation device (method of operating device depicted by Fig. 3) according to claim 16 (see claim 16 above), the method comprising:
providing a driver signal (signals from controller 10 to operate excitation device 56; Fig. 3; [0029]) to operate the vibrator so that the membrane vibrates (controller 10 operates and controls excitation device 56, where excitation device 56 is the activation means of piezo element 54, where the activation of piezo element 54 vibrates membrane 53; [0029] and [0016]) and generates an aerosol in the channel (liquid 55 is nebulized by the vibration of membrane 53; [0016]), and modulating the amplitude of the driver signal at a frequency of from 1 to 100 Hz (signals from controller 10 to operate excitation device 56 modulated with sinusoidal wave to a drive frequency of 1 Hz to 10 MHz as taught by Wilkerson; Wilkerson: [0152]; [0068]; [0093]; [0180]; [0126]; Examiner Note: the amplitude modulation range of 1 Hz to 10 MHz as taught by Wilkerson includes the invention’s disclosed amplitude modulation range of 1 Hz to 100 Hz, hence it would have been recognized, by a person of ordinary skill in the art, as an obvious try to select an amplitude modulation range of a drive signal from 1 Hz to 100 Hz as there are a finite number of identified and predictable solutions, and a person of ordinary skill has good reason to pursue the known options within his or her technical grasp, see MPEP §2144.05);
receiving an output signal from the optical sensor (controller 10 receives output signal from first receiving means 8 of the optical sensor, [0018]) and demodulating the output signal at the same frequency (demodulate output signals from receiving means 8 of optical sensor, where the demodulation of an output signal for analysis is taught by Wilkerson; Wilkerson: [0093], [0125], [0218]);
determining whether aerosol is present in the channel on the basis of the demodulated output signal (determination of whether aerosol is present in the mouthpiece 5 on the basis of the output signal from first receiving means 8 of the optical sensor, [0021], [0025], [0026]; Where the output signal from first receiving means 8 of the optical sensor is demodulated as taught by Wilkerson, see (b) above);
and ceasing to operate the vibrator if it is determined in step c) that no aerosol is present (Sommer: [0064], see provided translation).
Regarding claim 28, Feiner as modified teaches the invention as set forth in claim 27, wherein the amplitude of the driver signal is modulated at a frequency of from 5 to 40 Hz, such as about 10 Hz (signals from controller 10 to operate excitation device 56 modulated with sinusoidal wave to a drive frequency of 1 Hz to 10 MHz as taught by Wilkerson; Wilkerson: [0152]; [0068]; [0093]; [0180]; [0126]; see (a) of claim 27; Examiner Note: the amplitude modulation range of 1 Hz to 10 MHz as taught by Wilkerson includes the invention’s disclosed amplitude modulation frequency of from 5 Hz to 40 Hz, such as about 10 Hz, hence it would have been recognized, by a person of ordinary skill in the art, as an obvious try to modulate the drive signal at a frequency of from 5 Hz to 40 Hz, such as about 10 Hz, as there are a finite number of identified and predictable solutions, and a person of ordinary skill has good reason to pursue the known options within his or her technical grasp, see MPEP §2144.05).
Regarding claim 29, Feiner as modified teaches the invention as set forth in claim 27, wherein the amplitude of the driver signal is modulated at a frequency of about 10 Hz (signals from controller 10 to operate excitation device 56 modulated with sinusoidal wave to a drive frequency of 1 Hz to 10 MHz as taught by Wilkerson; Wilkerson: [0152]; [0068]; [0093]; [0180]; [0126]; see (a) of claim 27; Examiner Note: the amplitude modulation range of 1 Hz to 10 MHz as taught by Wilkerson includes the invention’s disclosed amplitude modulation frequency of about 10 Hz, hence it would have been recognized, by a person of ordinary skill in the art, as an obvious try to modulate the drive signal at a frequency of about 10 Hz, as there are a finite number of identified and predictable solutions, and a person of ordinary skill has good reason to pursue the known options within his or her technical grasp, see MPEP §2144.05).
Regarding claim 30, as best understood by the Examiner, Feiner as modified teaches the invention as set forth in claim 27, wherein the amplitude of the driver signal is modulated with a sinusoidal (signals from controller 10 to operate excitation device 56 modulated with sinusoidal wave as taught by Wilkerson; Wilkerson: [0152]; [0068]; [0093]; [0180]; [0126]; see (a) of claim 27), saw-tooth or square wave.
Regarding claim 31, Feiner as modified teaches the invention as set forth in claim 27, the method further comprising: in step a), periodically performing a scan to determine a resonant frequency of the aerosol generator and/or the membrane (Wilkerson: Fig. 20; [0134]); in step b) demodulating the output signal at the scanning frequency ([0093], where the electrical signal applied for a defined amount of time and then stopped suddenly is the drive signal 530, and this process is depicted in steps 2000 to 2020 of Fig. 20; [0125], lines 11 to then end of the paragraph); and in step c), determining whether aerosol is present in the channel on the basis of the demodulated output signal (determination of whether aerosol is present in the mouthpiece 5 on the basis of the output signal from first receiving means 8 of the optical sensor, [0021], [0025], [0026]; where the output signal from first receiving means 8 of the optical sensor is demodulated as taught by Wilkerson, see (b) in claim 31 above).
Claims 22, 26, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Feiner in view of Wilkerson in view of Sommer as applied to claims 16 and 27 above, and further in view of Bentvelsen et al. (US 20140339323 A1) hereinafter Bentvelsen.
Regarding claim 22, Feiner as modified teaches the invention as set forth in claim 16, but does not explicitly teach the controller (10; Fig. 3) is configured to determine a phase difference between the modulated driver signal and the output signal, and thereby to determine the velocity of the aerosol.
However, Bentvelsen teaches the analysis and control of aerosol output from an aerosol generating device (1; Abstract) with a time delay measurement device (13) that derives a timing measurement based on the generator drive signal and the aerosol density detector output (Abstract), where the aerosol density detector is an optical sensor ([0021]), and the velocity of the aerosol is determined from the time delay measurement ([0023]). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Feiner as modified with Bentvelsen such that the controller (10; Fig. 3) is configured to determine a phase difference between the modulated driver signal and the output signal (determine a time difference between the modulated driver signal and the output signal as taught by Bentvelsen; Bentvelsen: Abstract; [0021]) , and thereby to determine the velocity of the aerosol (Bentvelsen: [0023]) to derive an aerosol output rate to use as a feedback control mechanism (Bentvelsen: [0040]).
Regarding claim 26, Feiner as modified teaches the invention as set forth in claim 16, but fails to teach wherein the channel is part of a component that is removable from the rest of the device.
However, Bentvelsen teaches a mouthpiece detachable from a nebulizer ([0012]). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the channel (mouthpiece 5; Fig. 3) of Feiner as modified with the mouthpiece taught by Bentvelsen such that the channel (5; Fig. 3) is part of a component that is removable from the rest of the device (Bentvelsen: [0012], where the structure of the mouthpiece is removable from the rest of the device) as this is a routine and well-known characteristic in the art for inhalation devices, specifically for nebulizers (Bentvelsen: [0012], lines 3-4).
Regarding claim 32, Feiner as modified teaches the invention as set forth in claim 27, the method further comprising measuring the phase difference between the modulated driver signal and the output signal (determine a time difference between the modulated driver signal and the output signal as taught by Bentvelsen; Bentvelsen: Abstract; [0021), and thereby determining the velocity of the aerosol (Bentvelsen: [0023]).
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Feiner in view of Wilkerson in view of Sommer as applied to claims 16 and 27 above, and further in view of Kolb et al. (WO 2013098334 A1) hereinafter Kolb.
Regarding claim 23, Feiner as modified teaches the invention as set forth in claim 16, but does not teach a variable flow restrictor which restricts the flow rate of the air and aerosol to a maximum flow rate of about 20 L/min.
However, Kolb teaches a nebulizer with a vibrating mesh-type aerosol generator and a flow restrictor (pg. 25, lines 28-29), where the flow restrictor restricts the flow rate of the air and aerosol to about 18 L/min (pg. 25, line 30 to pg. 26, line 1; pg 26, lines 10-14). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Feiner as modified with Kolb such that a variable flow restrictor (Kolb: flow restrictor: pg. 25, lines 28-29) which restricts the flow rate of the air and aerosol to a maximum flow rate of about 20 L/min (Kolb: pg. 25, line 30 to pg. 26, line 1; pg 26, lines 10-14; Examiner Note: a flow rate of 18 L/min is interpreted as a flow rate of about 20 L/min when interpreting “about 20 L/min” under BRI, hence a flow rate of 18 L/min reads on the limitation of a flow rate of about 20 L/min) to increase patient comfort during therapy (Kolb: pg. 3, lines 28-32).
Regarding claim 24, Feiner as modified teaches the invention as set forth in claim 16, but fails to teach a sensor for measuring pressure in the channel and a signalling device capable of emitting light of varying intensity, wherein the controller is configured (i) to receive a signal representing the measured pressure and (ii) to cause the signalling device to emit light of lower intensity the further the measured pressure deviates from a target pressure.
However, Kolb teaches Kolb teaches a nebulizer with a vibrating mesh-type aerosol generator and a feedback system (Abstract) and a sensing device including a pressure sensor (pg. 7, lines 29-31), where the sensing device can output a signal to emit a light of varying intensity (pg. 24, lines 20-26). Additionally, Kolb teaches the controller receives signals from the pressure sensor and controls the signaling device in response to the received signals from the pressure sensor and emits a light to indicate to a user if the measured pressure matches a predetermined target pressure value or range (pg. 8, lines 6-13; pg. 24, lines 20-26). Kolb further teaches the signaling device emits a light of higher intensity when the measured pressure value is within the predetermined target pressure range, and emits a light of a lower intensity when the measured pressure value is outside of the predetermine target pressure range (pg. 8, lines 22-25). Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Feiner as modified with Kolb such that Feiner as modified further comprises a sensor for measuring pressure in the channel (Kolb: pressure sensor; pg. 7, lines 29-31) and a signalling device capable of emitting light of varying intensity (Kolb: Abstract; pg. 24, lines 20-26), wherein the controller (10; Fig. 3) is configured (i) to receive a signal representing the measured pressure (Kolb: pg. 8, lines 6-13) and (ii) to cause the signalling device to emit light of lower intensity the further the measured pressure deviates from a target pressure (Kolb: pg. 8, lines 22-25) to improve the quality and consistency of therapy for a user (Kolb: pg. 20, lines 23-29).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Feiner in view of Wilkerson in view of Sommer as applied to claims 16 and 27 above, and further in view of Freeman & Freeman (US 20190247596 A1) hereinafter Freeman.
Regarding claim 25, Feiner as modified teaches the invention as set forth in claim 16, but fails to teach the channel(5; Fig. 3) has an internal volume between the membrane and the optical sensor of less than 5 cm3.
However, Freeman teaches an inhalation device with a third channel portion (217; Fig. 2) having a maximum diameter of 2 mm and a maximum length of 10 mm ([0071]), hence the third channel portion (217) has a maximum volume of 3.14 cm3. Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the volume of the channel taught by Feiner as modified with the volume of the third channel portion taught by Freeman such that the channel (5; Fig. 3) has an internal volume between the membrane and the optical sensor of less than 5 cm3 (Freeman: volume of 3.14 cm3, [0071]) to improve the consistency of air and aerosol flow (Freeman: [0071]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Croft & Douglas (US 20090026883 A1): Regarding a piezoelectric drive component and sinusoidal modulation of a drive signal.
Saraf (US 20030164658 A1): Regarding a frequency sweeps with a profile sweep of 1 Hz to 100 Hz to identify resonant frequency.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAYLE DALE whose telephone number is (571)272-1080. The examiner can normally be reached Monday-Friday from 8:45am to 5:45pm ET.
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, Brandy Lee can be reached at (571) 270-7410. 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.
/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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