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 .
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 3 and 6 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 3 recites “apparatus of claim 1… the mesh screen” wherein “a mesh screen” is only recited previously in claim 2 and not claim 1. As such, there is a lack of sufficient antecedent basis for “the mesh screen”. The examiner will interpret claim 3 as depending on claim 2 instead of claim 1.
Claim 6 recites “the first region and the second region can be independently activated to generate aerosol droplets” wherein the usage of “can be” herein makes the claim unclear if this is required capability of the mesh regions or simply a intended use capability that is not required for the claim. Examiner recommends amending “can be” to more specific operable language.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Van Der Sluis (US 20140346245 A1), henceforth Van, in view of Borkovec (US 20160262457 A1).
Regarding claim 1, Van discloses an apparatus (nebulizer 2, Fig. 1) for optimal pulmonary therapeutic agent delivery (title, Fig. 1-7, nebulizer for delivering therapeutic agent to lungs), the apparatus (2) comprising:
an inlet (6) for airflow (Fig. 1 and [0034]);
a reservoir (10) containing a therapeutic agent (12) (Fig. 1 and [0035]);
an aerosol generator (14) configured to generate an aerosol of the therapeutic agent (Fig. 1 and [0036], actuator 14 generates an aerosol through vibrating the agent 12);
an outlet (8) configured to deliver the aerosol to a user (Fig. 1 and [0034-0036]); and
a control module (Fig. 1, control unit 17 [0040]) configured to provide an output signal to the aerosol generator (Fig. 1 and [0040] control unit 17/processor 18 sends output control signals to the actuator 14), wherein:
the apparatus is configured to produce a first droplet size distribution of the aerosol at a first flow rate of the airflow ([0008, 0010] the control unit is capable of being configured of providing specific droplet sizes and output/flow rates thus capable of having a first droplet size distribution of the aerosol at a first flow rate of the airflow);
the apparatus is configured to produce a second droplet size distribution of the aerosol at a second flow rate of the airflow ([0008, 0010] the control unit is capable of being configured of providing specific droplet sizes and output/flow rates thus capable of having a second droplet size distribution of the aerosol at a second flow rate of the airflow).
Van does not disclose an airflow sensor configured to detect the airflow through the apparatus; wherein the control module configured to receive an input signal from the airflow sensor and provide an output signal to the aerosol generator; the apparatus is configured to produce a first droplet size distribution of the aerosol at a first flow rate of the airflow;
the apparatus is configured to produce a second droplet size distribution of the aerosol at a second flow rate of the airflow;
the first droplet size distribution is larger than the second droplet size distribution;
and the first flow rate is lower than the second flow rate.
However, Borkovec teaches an analogous aerosol generating apparatus (title) comprising an analogous aerosol generator (40) for making aerosols (see [0029]) and an analogous control module (46) for controlling the aerosol generator (40) (see [0032]), wherein there may be provided an airflow sensor (24) configured to detect the airflow through the apparatus ([0019-0020] airflow sensor 24 enables detection of airflow), wherein the control module (40) configured to receive an input signal from the airflow sensor (24) and provide an output signal to the aerosol generator (40) ([0020, 0025] airflow sensor detects airflow from user puffing/sucking on the outlet to thus send a signal to the control module and turn on the analogous aerosol generator 40),
the apparatus is configured to produce a first droplet size distribution of the aerosol at a first flow rate of the airflow ([0038] the flow rate and droplet size of the aerosol generator may be adjusted, thus making a first droplet size distribution at a first flow rate of the airflow);
the apparatus is configured to produce a second droplet size distribution of the aerosol at a second flow rate of the airflow ([0038] the flow rate and droplet size of the aerosol generator may be adjusted, thus further making a second droplet size distribution at a second flow rate of the airflow);
the first droplet size distribution is larger than the second droplet size distribution; and the first flow rate is lower than the second flow rate ([0038] “Hence, the particle sizes of the aerosols can be preselected in hardware by the form or dimensions of the inlet opening 64. High airflow without low or no turbulence results in high dilution, which reduces the interaction between particles and stops them growing in size. Low airflow results in low dilution, which, in addition or alternative to the high turbulence, increases the probability of the particles growing”, as recited by the reference at a first large droplet size may correspond with a first low airflow, and a second smaller droplet size may correspond with a higher second airflow, thus the first droplet size distribution is larger than the second droplet size distribution; and the first flow rate is lower than the second flow rate).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the apparatus of Van to comprise the airflow sensor (24) wherein the control module configured to receive an input signal from the airflow sensor and provide an output signal to the aerosol generator as taught by Borkovec in order to enable easy activation of the aerosol generator when it needs to be used (Borkovec [0019-0025]), and further obvious to have provided the apparatus of Van to be configured to produce a first droplet size distribution of the aerosol at a first flow rate of the airflow; the apparatus is configured to produce a second droplet size distribution of the aerosol at a second flow rate of the airflow; the first droplet size distribution is larger than the second droplet size distribution; and the first flow rate is lower than the second flow rate as taught by Borkovec as being able to adjust the airflow to then further adjust the droplet size as such would enable further customization in the therapeutic agent dosage.
Regarding claim 2, Van in view of Borkovec discloses the invention of claim 1.
Van further discloses wherein the aerosol generator (14) comprises a mesh screen (16) (Fig. 1 and [0037] mesh screen 16).
Regarding claim 3, Van in view of Borkovec discloses the invention of claim 2 (see 112b above).
Van further discloses wherein the mesh screen (16) is configured to generate aerosol droplets between 1 µm and 10 µm when vibrated ([0058] 5 micron (µm) aerosol droplet formed when vibrated).
Regarding claim 15, Van in view of Borkovec discloses the invention of claim 1.
Van further discloses wherein the aerosol comprises droplets ([0066-0067], Abstract, aerosol comprises droplets), and wherein during use the control module is configured to adjust the output signal to control a median diameter of the droplets in the aerosol ([0066, 0061-0062], Fig. 6, the control module adjusts the output signal when activated to control the MMD/mean median diameter of the droplets).
Regarding claim 16, Van discloses a method of controlling droplet size in a pulmonary therapeutic aerosol, the method comprising:
wherein the nebulizer apparatus comprises:
an inlet (6) (Fig. 1, [0034]);
a control module (17) (Fig. 1, [0073]);
a therapeutic agent (12) (Fig. 1, [0035]);
an aerosol generator (14) (Fig. 1 and [0036]); and
an outlet (8) (Fig. 1 and [0034]);
providing an input signal to the control module ([0058-0062] the controller/processor receives an input signal for altering the pulse length/period/cycles it will then use to communicate to the aerosol generator 14);
providing an output signal from the control module to the aerosol generator to generate an aerosol of droplets of the therapeutic agent ([0058-0062] the controller/processor outputs instructions to the aerosol generator/actuator 14 that will generate droplets of the therapeutic agent 12 therein); and
adjusting the output signal to control droplet size of the therapeutic agent (see [0062] wherein the output signal may be adjusted to control the droplet size of the therapeutic agent).
Van does not disclose measuring an inlet airflow in a nebulizer apparatus, providing an input signal to the control module, wherein the input signal is dependent on the inlet airflow.
However, Borkovec teaches an analogous aerosol generating apparatus (title) comprising an analogous aerosol generator (40) for making aerosols (see [0029]) and an analogous control module (46) for controlling the aerosol generator (40) (see [0032]), wherein there may be provided an airflow sensor (24) configured to detect the airflow through the apparatus and having the method of measuring an inlet airflow in a nebulizer apparatus ([0019-0020] airflow sensor 24 enables detection of inlet airflow), wherein the control module (40) configured to receive an input signal from the airflow sensor (24) and provide an output signal to the aerosol generator (40), wherein the input signal is dependent on the inlet airflow ([0020, 0025] airflow sensor detects airflow from user puffing/sucking on the outlet to thus send a signal to the control module and turn on the analogous aerosol generator 40).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the apparatus of Van to comprise the airflow sensor (24) to have the method of measuring an inlet airflow in a nebulizer apparatus, providing an input signal to the control module, wherein the input signal is dependent on the inlet airflow as taught by Borkovec in order to enable easy activation of the aerosol generator when it needs to be used (Borkovec [0019-0025]).
Regarding claim 17, Van in view of Borkovec discloses the invention of claim 16.
Van further discloses wherein the droplets of the therapeutic agent have a diameter of between approximately 1 µm and 10 µm ([0058] “an exemplary target droplet size (MMD) of 5 microns”).
Regarding claim 18, Van in view of Borkovec discloses the invention of claim 16.
Van further discloses the aerosol generator comprises a mesh screen (16) (Fig. 1 and [0037]); and generating the aerosol of droplets of the therapeutic agent comprises vibrating the mesh screen ([0036-0037] the actuator 14 vibrates the mesh screen 16 in order to form the droplets of aerosol through the mesh).
Regarding claim 19, Van in view of Borkovec discloses the invention of claim 16.
Van further discloses wherein adjusting the output signal comprises altering a frequency of the output signal ([0042-0043, 0070] and claim 2, the frequency of the output signal being an activation of the actuator is adjustable/alterable).
Regarding claim 20, Van in view of Borkovec discloses the invention of claim 16.
Van further discloses wherein adjusting the output signal comprises altering a voltage of the output signal ([0063]).
Claims 4-5 and 7-14 are rejected under 35 U.S.C. 103 as being unpatentable over Van Der Sluis (US 20140346245 A1), henceforth Van, in view of Borkovec (US 20160262457 A1) in view of Blick (US 20210346612 A1).
Regarding claim 4, Van in view of Borkovec discloses the invention of claim 2.
Van does not disclose the mesh screen comprises a first region comprising a first pore size; and the mesh screen comprises a second region comprising a second pore size.
However, Blick teaches an analogous nebulizer mesh (title) being a mesh screen (Fig. 1-10), wherein the mesh screen (300) (Fig. 3) comprises a first region (310) (Fig. 3) comprising a first pore size (Abstract); and the mesh screen (300) comprises a second region (320) (Fig. 3) comprising a second pore size (Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the mesh screen (16) of Van such that the mesh screen comprises a first region comprising a first pore size; and the mesh screen comprises a second region comprising a second pore size as taught by Blick in order to provide both delivery of agent to the lungs but also be able to deliver an enjoyable taste sensation when in use (Blick [0008]).
Regarding claim 5, Van in view of Borkovec and Blick discloses the invention of claim 4.
Blick further teaches the first region and the second region are each configured to generate aerosol droplets with a diameter between 1 m and 10 pm when vibrated (Abstract, the first and second regions can produce droplets of 1-5 microns and 5-30 microns respectively, [0005] vibration used).
Regarding claim 7, Van in view of Borkovec discloses the invention of claim 1.
Van discloses wherein the aerosol generator (14) comprises a plurality of mesh screens (See Annotated 1 of Van, wherein the mesh 16 may be divided into a first mesh and second mesh thus having a plurality of mesh screens, they may be divided as the mesh 16 is made up of a plurality of individual nozzle apertures [0037]).
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However, Blick teaches an analogous nebulizer mesh (title) being a mesh screen (Fig. 1-10), wherein the mesh screen a plurality of mesh screens (Fig. 1-10, Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the mesh screen (16) of Van such that the mesh screen comprises a plurality of mesh screens as taught by Blick in order to provide both delivery of agent to the lungs but also be able to deliver an enjoyable taste sensation when in use, and enable multiple different droplet sizes to be sent to the user (Blick [0008]).
Regarding claim 8, Van in view of Borkovec and Blick discloses the invention of claim 7.
Blick further teaches wherein the plurality of mesh screens comprises: a first mesh screen (310) (Fig. 3) comprising a first pore size (Abstract); and a second mesh screen (320) (Fig. 3) comprising a second pore size (Abstract), the second mesh pore size is different than the first mesh pore size (Abstract).
Regarding claim 9, Van in view of Borkovec and Blick discloses the invention of claim 8.
Blick further teaches wherein the first mesh screen and the second mesh screen are each configured to generate aerosol droplets with a diameter between 1 m and 10 pm when vibrated (Abstract, the first and second mesh screens can produce droplets of 1-5 microns and 5-30 microns respectively, [0005] vibration used).
Regarding claim 10, Van in view of Borkovec and Blick discloses the invention of claim 8.
Van further discloses the first mesh screen is a first distance from the outlet (8) (See Annotated Fig. 1, wherein the indicated first mesh screen is a first distance from the outlet 8);
the second mesh screen is a second distance from the outlet (8) (See Annotated Fig. 1, wherein the indicated second mesh screen is a second distance from the outlet 8); and
the first distance is greater than the second distance (See Annotated Fig. 1, wherein the first mesh screen is a greater distance from the outlet 8 than the second mesh screen).
Regarding claim 11, Van in view of Borkovec and Blick discloses the invention of claim 8.
Blick further teaches wherein the plurality of mesh screens comprises a third mesh screen (Fig. 7, [0068], there may be further provided a third mesh screen 730).
Regarding claim 12, Van in view of Borkovec and Blick discloses the invention of claim 11.
Blick further teaches wherein the first mesh screen, the second mesh screen and the third mesh screen are each configured to generate aerosol droplets between 1 µm and 10 µm when vibrated (Abstract, the first and second mesh screens can produce droplets of 1-5 microns and 5-30 microns respectively, [0005] vibration used) ([0070] the third mesh screen can provide droplets of 2-5 microns).
Regarding claim 13, Van in view of Borkovec and Blick discloses the invention of claim 11.
Blick further teaches wherein the first mesh screen is configured to generate aerosol droplets with a diameter of approximately 1 µm when vibrated, the second mesh screen is configured to generate aerosol droplets with a diameter of approximately 5 µm when vibrated and the third mesh screen is configured to generate aerosol droplets with a diameter of approximately 10 µm when vibrated ([0071] describes a mesh screen with up to four different screens wherein a first mesh screen may have a droplet size of 1 micron, a second mesh with 1-5 microns, and a third mesh of 5-10 microns).
Regarding claim 14, Van in view of Borkovec and Blick discloses the invention of claim 11.
Blick further teaches the third mesh screen comprises a third mesh pore size; and the third mesh screen size is different than the first mesh pore size and the second mesh pore size ([0068, 0071]).
Claims 4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Van Der Sluis (US 20140346245 A1), henceforth Van, in view of Borkovec (US 20160262457 A1) in view of Miller (US 20180169682 A1).
Regarding claim 4, Van in view of Borkovec discloses the invention of claim 2.
Van does not disclose the mesh screen comprises a first region comprising a first pore size; and the mesh screen comprises a second region comprising a second pore size.
However, Miller teaches an analogous nebulizer mesh (title, abstract, Fig. 5, [0005, 0064]) being a mesh screen (102) (Fig. 5), wherein the mesh screen (102) (Fig. 5) comprises a first region (220) (Fig. 5, [0064]) comprising a first pore size ([0064] first metal mesh 220 comprises a different pore size); and the mesh screen (102) comprises a second region (222) (Fig. 5, [0064]) comprising a second pore size ([0064] second metal mesh 222 comprises a different second pore size than the first mesh 220).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the mesh screen 16 such that there is a first region comprising a first pore size; and the mesh screen comprises a second region comprising a second pore size as taught by Miller in order to be able to dynamically change the nebulizer spray characteristics (Miller [0064]).
Regarding claim 6, Van in view of Borkovec and Miller discloses the invention of claim 4.
Miller further teaches the first region (220) and the second region (222) can be independently activated to generate aerosol droplets ([0064] “In an embodiment, the two different meshes 220 and 222 are designed to operate at different frequencies, for example. In this way, the piezoelectric element 224 drives each metal mesh 220 or 222 independently of the other by changing the frequency or amplitude”).
Regarding claim 7, Van in view of Borkovec discloses the invention of claim 1.
Van discloses wherein the aerosol generator (14) comprises a plurality of mesh screens (See Annotated 1 of Van, wherein the mesh 16 may be divided into a first mesh and second mesh thus having a plurality of mesh screens, they may be divided as the mesh 16 is made up of a plurality of individual nozzle apertures [0037]).
Van does not explicitly disclose wherein the aerosol generator comprises a plurality of mesh screens.
However, Miller teaches an analogous nebulizer mesh (title, abstract, Fig. 4, [0005, 0063]) being a mesh screen (102) (Fig. 6), wherein the mesh screen (102) (Fig. 6) comprises a plurality of mesh screens (Fig. 4, [0063]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the mesh 16 of Van with the plurality of mesh screens of Miller in order to enable independent frequency vibrations for each (Miller [0063]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN S ALBERS whose telephone number is (571)272-0139. The examiner can normally be reached Monday-Friday 7:30 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at (571) 270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/KERI J NELSON/Primary Examiner, Art Unit 3786
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