DETAILED ACTION
This office action is in response to the amendment filed 4/9/2026. As directed by the amendment, claims 1, 18 and 21 have been amended, claims 12-13 have been cancelled, and no claims have been newly added. Thus, claims 1-11 and 14-22 are presenting pending in this application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1 and 18, line of claim 1 recites, “wherein the control device does not include an electric controller”, and line 12 of claim 18 recites, “wherein the control device does not include an electronic processor”. The originally filed specification discloses that the control device may cause a variation in a resistive load (60), an inductive load (70), or a capacitive load (80) by varying resistive and/or capacitive and/or inductive loading and/or phase and could be a variable potentiometer or a PIC microcontroller (102) (page 5, line 16-page 6, line 8). However, a device configured to cause variation in a resistive load, an inductive load, or a capacitive load would read on the broadest reasonable interpretation of an “electronic controller”, as an such devices would adjust a control of a flow of electrons to the device. Furthermore, a device that may cause a variation in a resistive load, an inductive load, or a capacitive load, such as a potentiometer as recited in applicant’s originally filed disclosure would not inherently lack an electronic processor, as an electronic processor can be used as a potentiometer or be configured to cause a variation in a resistive load, an inductive load, or a capacitive load. Therefore, the limitation “wherein the control device does not include an electric controller/processor” was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention.
Regarding claim 10, lines 1-3 recites, “wherein the interface is additionally configured to be linked with a detection device and to automatically adjust aerosol output according to a feed from the detection device.” Claim 1, from which claim 10 depends from, recites, that the control device does not include an electronic controller. However, applicant’s originally filed disclosure states that the device may include a PIC microcontroller in response to a control system (page 5, lines 25-29), and therefore, the feature of the interface additionally configured to be linked with a detection device and to automatically adjust aerosol output according to a feed from the detection device while also not including an electronic controller was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention.
Claims 2-9, 11-17 and 19-20 are rejected for being either directly or indirectly depending from a rejected claim base.
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 21-22 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.
Regarding claim 21, line 10 recites, “wherein the nebulizer device is only manually controlled”. It is unclear how to determine the metes and bounds of the limitation “only manually controlled” and whether a user manually controlling a device by entering a value, which is fed into a microprocessor to adjust device settings would read on the broadest reasonable interpretation of being “only manually controlled”. For purposes of examination, a user manually entering values into a control system, wherein the control system does not automatically adjust values based on other feedback, such as feedback from a sensor, would read on the broadest reasonable interpretation of being “only manually controlled”.
Claims 22 is rejected for being either directly or indirectly depending from a rejected claim base.
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 of this title, 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.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Casey et al (2013/0291859) in view of Maeda et al (2011/0290241).
Regarding claim 18, Casey discloses a system, comprising: an aerosol generator (3) (nebulizer head) (para [0034]), a power source or a main controller configured to drive the aerosol generator (3) (plug (4) connects to host system or device (para [0042]), and plug (4) inputs 4.75V to 5.25 V DC to the controller (2) for driving the aerosol generator (para [0039]), and a nebulizer control device (2) (controller) separate and distinct from the aerosol generator (3) (controller (2) can be unplugged from the aerosol generator (3)) (para [0035]), comprising; a nebulizer control device comprising a manually adjustable user interface (2) (controller linked to nebulizer head (3)), an input cable (5) extending from the manually adjustable user interface (2) for connection to a power source or a main controller (cable includes USB plug (4) to connect to host computer or portable device) (para [0042]), and an output cable (6) extending from the manually adjustable user interface (2) for connection to an aerosol generator (3) (nebulizer) (para [0036]), wherein the manually adjustable user interface (2) is adapted to modify a signal conveyed from the input cable (5) and to provide a modified signal on the output cable (6) to adjust operation of the aerosol generator (controller (2) receives an input within the range of 4.75V to 5.25 V DC as per USB 2.0 electrical input requirement, which is modified by boost circuit (10) to generate a nominal 12V DC voltage required by the drive circuit (12) (para [0039]), and drive circuit (12) receives the nominal 12V DC voltage and generates an output sine wave of approximately 100 V AC which is fed into the nebulizer head (3) (para [0038]).
Casey does not disclose the manually adjustable user interface is configured to directly vary a resistive load, an inductive load, or a capacitive load of a signal generated by the power source or main controller, wherein the control device does not include an electronic processor.
However, Maeda in fig 18 teaches a nebulizer control device including a manually adjustable user interface (5) (power control unit) configured to receive an input from a power source (16) (oscillation circuit) and provide an output to a vibrator (21) (para [0105]), wherein, in response to a manual adjustment of the manually adjustable user interface (5) (user can press switches (51-53) in operating section) (para [0106]), the manually adjustable user interface (5) is configured to directly vary a resistive load (amplitude adjusting section (57 of Maeda) includes a variable resistor (54 of Maeda), and when the user pushes one of the switches, one of the three switch terminals (55 of Maeda) is selected in accordance with the pushed switch to select a corresponding resistor (54 of Maeda)) (para [0110]) of a signal generated by a main controller (16) to the output to the vibrator (21) to adjust operation of the aerosol generator (2) (atomization unit) (power control unit (5) includes amplitude adjusting section (57) which adjusts the oscillation signal in which the amplitude is adjusted to the vibrator (21)) (para [0111]), wherein the control device does not disclose an electronic processor (as shown in fig 18, control device (5) includes switches (51-53), variable resistor (54), and an amplifier (56), and therefore is not considered to include an electronic processor).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Casey by substituting Casey’s boost circuit control system with a control system including a variable resistor and a plurality of switches controllable by a user to adjust an amplitude of a signal, and configuring the host device to provide an oscillating signal, and providing the user interface with an amplitude adjusting section so that, in response to a manual adjustment of the manually adjustable user interface, the manually adjustable user interface is configured to directly vary a resistive load a signal generated by the power source or the main controller and conveyed from the input cable to the output cable to adjust operation of the aerosol generator and wherein the control device does not include an electronic processor as taught by Maeda as it would be a simple substitution of one known control mechanism for a nebulizer for another, which would allow a user to adjust an amplitude of a vibrator of the aerosol generator to adjust a spray amount or inhaling time (Maeda, para [0111]), so that the appropriate amount or inhaling time can be selected according to the property of the medicine, the age of the user, the body condition of the user, or the like (Maeda, para [0112]). See MPEP 2143(I)(B).
Regarding claim 19, the modified Casey’s device discloses modifying the signal causes an increase or decrease in power provided to the aerosol generator (2 of Maeda) (user interface (5 of Maeda) is configured to damp or adjust the amplitude of the oscillating signal, which would cause an increase or decrease in power provided to the aerosol generator) (Maeda, para [0109]).
Regarding claim 20, Casey in fig 2 discloses the input cable (5) is disconnectable from the power source or the main controller (using plug (4)) (para [0036]) and wherein the output cable (6) is disconnectable from the aerosol generator (3) (using proprietary plug (7)) (para [0035]).
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Casey et al (2013/0291859) in view of Maeda et al (2011/0290241) and Weinstein et al (2010/0024816).
Regarding claim 21, Casey discloses a device whose ordinary use discloses a method for controlling a nebulizer, comprising: conveying, by a nebulizer control device (2) a signal from a power source or a main controller (controller (2) receives an input within the range of 4.75V to 5.25 V DC as per USB 2.0 electrical input requirement (para [0039]), which is generated by a power source (host) (para [0042]) to an aerosol generator (3) (nebulizer head) (para [0034]), through an input cable (5) connected to the power source or main controller (host) (para [0042]) and an output cable (6) connected to the aerosol generator (3) (cable includes USB plug (4) to connect to host computer or portable device) (para [0042]), receiving, at a manually adjustable user interface of the nebulizer control device (2) (controller) disposed between and connected to the input cable (5) and the output cable (6), a manual input for modifying the signal (user can adjust a mode of operation using the controller (2)) (para [0056]); and providing a modified signal to the aerosol generator (controller (2) receives an input within the range of 4.75V to 5.25 V DC as per USB 2.0 electrical input requirement, which is modified by boost circuit (10) to generate a nominal 12V DC voltage required by the drive circuit (12) (para [0039]), and drive circuit (12) receives the nominal 12V DC voltage and generates an output sine wave of approximately 100 V AC which is fed into the nebulizer head (3) (para [0038]).
Casey does not disclose that, in response to a manual adjustment of the manually adjustable user interface, directly modifying the signal to provide a modified signal to the aerosol generator, wherein the nebulizer control device is only manually controlled.
However, Maeda in fig 18 teaches a nebulizer control device (5) (power control unit) including a manually adjustable user interface (50) (operating section) configured to receive an input from an oscillation circuit (16) and provide an output to a vibrator (21) (para [0105]), wherein, in response to a manual adjustment of the manually adjustable user interface (5) (user can press switches (51-53) in operating section) (para [0106]), the manually adjustable user interface (5) directly modifying a signal conveyed from the input from oscillation circuit (16) and providing a modified signal to the output to the vibrator (21) to adjust operation of the aerosol generator (2) (atomization unit) (power control unit (5) includes amplitude adjusting section (57) which adjusts the oscillation signal in which the amplitude is adjusted to the vibrator (21)) (para [0111]), wherein the nebulizer control device is only manually controlled (the control mechanism involves a user pressing switches without any other control from a microprocessor, and therefore is considered to be only manually controlled).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of Casey by configuring the host device to provide an oscillating signal, and providing the user interface with an amplitude adjusting section so that, in response to a manual adjustment of the manually adjustable user interface, the manually adjustable user interface is configured to directly modify a signal to provide a signal to the aerosol generator by adjusting an amplitude of the signal, wherein the nebulizer control device is only manually controlled as taught by Maeda in order to allow a user to adjust an amplitude of a vibrator of the aerosol generator to adjust a spray amount or inhaling time (Maeda, para [0111]), so that the appropriate amount or inhaling time can be selected according to the property of the medicine, the age of the user, the body condition of the user, or the like (Maeda, para [0112]).
The now-modified Casey’s method discloses that an extent of adjustment by the manually adjustable user interface is in a range greater than a shut-off value (lowest adjustment capable by the operating section (50 of Maeda) is a weak (Low) setting, which is greater than a shut-off value) (Maeda, para [0106])
The now-modified Casey’s method does not disclose that an extent of adjustment by the manually adjustable user interface is limited a range less than a range from shut-off to maximum output rate.
However, Weinstein discloses a respiratory device configured to provide a medicament to a patient, wherein the device includes a controller (502) configured to set operational limits so as not to drown a patient, and to prevent an operating power from exceeding one or more preset limits (para [0073]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the interface of Casey to limit an extent of adjustment to a range less than a maximum output rate by providing set operational limits to prevent a power from exceeding one or more preset limits as taught by Weinstein to provide preset limits to ensure the safety of the patient and prevent the user from operating the device at operational values that may be inappropriate (Weinstein, para [0073]).
Regarding claim 22, the modified Casey’s reference discloses directly varying, by the manually adjustable user interface, a resistive load of the signal (amplitude adjusting section (57 of Maeda) includes a variable resistor (54 of Maeda), and when the user pushes one of the switches, one of the three switch terminals (55 of Maeda) is selected in accordance with the pushed switch to select a corresponding resistor (54 of Maeda)) (para [0110]).
Response to Arguments
Applicant's arguments filed 4/9/2026 have been fully considered but they are not persuasive.
Applicant argues on page 8, first full paragraph of applicant’s remarks that support for independent claim 1 can be found in fig 5 and paragraphs [0019] and [0040] of the application as filed, as fig 5 discloses a power source (101) and a microcontroller (102) as well as an embodiment that is not electronically controlled. However, a device configured to cause variation in a resistive load, an inductive load, or a capacitive load would read on the broadest reasonable interpretation of an “electronic controller”, as an such devices would adjust a control of a flow of electrons to the device (elements such as resistors, capacitors, etc - which were not disclosed in the originally filed disclosure - are electronic components that would control the flow of electrons in the device). Therefore, the limitations of claims 1 and 10 were not described in the originally filed disclosure in such a way as to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention.
Applicant argues on page 8, second full paragraph-page 9, first full paragraph of applicant’s remarks, that Casey does not disclose the limitation, “wherein the control device does not include an electronic controller”, as Casey includes a microcontroller (11). However, as discussed above, the subject matter of claim 1 is considered to be new matter, as the components in the control device in applicant’s originally filed disclosure is considered to read on the broadest reasonable interpretation of an “electronic controller.” Regarding claim 18, although Casey’s microprocessor reads on the limitation “an electronic processor”, applicant’s argument is moot in view of the new grounds of rejection in view of Maeda, which in fig 18 teaches a nebulizer control device (5) (power control unit) including a manually adjustable user interface (50) (operating section) that includes switches (51-53) (para [0106]), wherein the pressing of switches (51-53) adjusts a variable resistor (paras [0109]), and therefore the prior art discloses a manually adjustable user interface only uses a variable resistor and therefore the feature of a control device for a nebulizer that does not require a microcontroller or microprocessor or a system that has programmable logic or software is known in the art. Therefore, it would have been obvious to the skilled artisan, upon seeing Maeda’s disclosure, to substitute Casey’s boost circuit control system with a control system including a variable resistor and a plurality of switches controllable by a user to adjust an amplitude of a signal, and configuring the host device to provide an oscillating signal, and providing the user interface with an amplitude adjusting section so that, in response to a manual adjustment of the manually adjustable user interface, the manually adjustable user interface is configured to directly vary a resistive load a signal generated by the power source or the main controller and conveyed from the input cable to the output cable to adjust operation of the aerosol generator and wherein the control device does not include an electronic processor, as it would be a simple substitution of one known control mechanism for a nebulizer for another, which would allow a user to adjust an amplitude of a vibrator of the aerosol generator to adjust a spray amount or inhaling time (Maeda, para [0111]), so that the appropriate amount or inhaling time can be selected according to the property of the medicine, the age of the user, the body condition of the user, or the like (Maeda, para [0112]). See MPEP 2143(I)(B). Therefore, the rejection is maintained.
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.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785
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