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 .
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 canister port and a valve of claim 16 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.
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 “canister port and valve” recited in line 2 of claim 16 should be mentioned and described in the specification.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The claims are rejected given that they amount to nor more than suggestive limitations given that the “counterpart component” is not positively recited by claim 1 and would therefore, fail to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. It is suggested that Applicant amends claim 1 to positively recite the counterpart component to overcome the rejection.
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 1-6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Mahoney (US 20080283049 A1) in view of Addington (WO 2014164175 A2) and Denyer (WO 2011058477 A1).
Regarding claim 1, Mahoney disclose, nebulizer (FIG. 1-3 Nebulizer 100 as set forth in [0057]) comprising: a nebulizer body (FIG. 1-3 Housing 40 as set forth in [0057]), the nebulizer body comprising a nebulizer mouthpiece (FIG. 1-3 Exit port 10 as set forth in [0057]; the medication being delivered toward the user’s mouth as set forth in [0004], [0060], and [0068]), a nebulizer top (FIG. 1-3 Upper housing 2 as set forth in [0057]), and a nebulizer bottom (FIG. 1-3 Lower housing 3 as set forth in [0057]), wherein the nebulizer top is configured to detachably couple to the nebulizer bottom (FIG. 1-3 Upper housing 2 and lower housing 3 may be registered to one another by cooperation between holes 12 of the lower housing 3 and alignment posts 16 of the upper housing 2 as set forth in [0057]); a nozzle assembly (FIG. 1 Nebulizer tube 1 as set forth in [0057] and [0064]-[0065]), the nozzle assembly comprising: a suction line having a suction line inlet (FIG. 3 Liquid feed channel 6 having an inlet end 42 as set forth in [0064]), a suction line outlet (FIG. 3 The suction line outlets at throat 43 where the feed channel 6 connects to the gas channel 5 as set forth in [0064]), and a suction line longitudinal axis passing through the suction line inlet and the suction line outlet (The vertical axis of the liquid feed channel); a nozzle integrally joined to the suction line (FIG. 3 Gas channel 5 as set forth in [0064]), the nozzle having a nozzle inlet (FIG. 3 Inlet end 41 of the nebulizer tube 1 as set forth in [0065]), a nozzle outlet (FIG. 3 The throat 43 of the gas channel 5 as set forth in [0064]), and a nozzle longitudinal axis passing through the nozzle inlet and the nozzle outlet (The horizontal axis passing through the nozzle), wherein the nozzle longitudinal axis is substantially perpendicular to the suction line longitudinal axis (As shown in FIG. 3), and wherein the nozzle assembly is configured to detachably couple to the nebulizer body between the nebulizer top and the nebulizer bottom (FIG. 3 Nebulizer tube 1 that mates with a complementary positioning feature 11 of the lower housing 3 to locate the nebulizer tube 1 within the housing 40 and mates with an nozzle capture feature 15 of the upper housing 2 to stabilize the tube 1 within the nebulizer 100, FIGS. 8-10 as set forth in [0066]); and a diffuser projecting from an inner surface of the nebulizer top or the nebulizer bottom towards the nozzle assembly (FIG. 6 Impactor 9, which may be provided as part of the upper housing 2 as set forth in [0066]), the diffuser comprising an impact surface (FIG. 6 Where nozzle 8 strikes curved impactor 9 as set forth in [0066]).
Mahoney fails to explicitly disclose, wherein at least one of the nebulizer top and the nozzle assembly is replaceable with a counterpart component having at least one different property, wherein the counterpart component is selected to produce a target droplet size for a medicine disposed in the nebulizer.
However, Mahoney does teach that the nebulizer top, that includes the diffuser (FIG. 1-3 Upper housing 2 and lower housing 3 may be registered to one another by cooperation between holes 12 of the lower housing 3 and alignment posts 16 of the upper housing 2 as set forth in [0057], FIG. 6 Impactor 9, which may be provided as part of the upper housing 2 as set forth in [0066]), and the nozzle assembly (FIG. 3 Nebulizer tube 1 that mates with a complementary positioning feature 11 of the lower housing 3 to locate the nebulizer tube 1 within the housing 40 and mates with an nozzle capture feature 15 of the upper housing 2 to stabilize the tube 1 within the nebulizer 100, FIGS. 8-10 as set forth in [0066]) are individually formed, and further teaches alternate embodiments of the diffuser and nozzle assembly (FIG. 23 and 26 Nebulizer tube 301, 501, wherein the nebulizer tubes of the present invention can include multiple channels, such as the three-channel nebulizer tube 501 depicted in FIGS. 26-28 as set forth in [0077]; FIGS. 56-57 Ring feature 840 may be added about a mesa 839, the impactor, to facilitate the creation of a resonant annular channel 841 in the housing 832 The fundamental resonant frequency of the annular channel 841 may be tuned to help generate particles of a preferred size, which may be used with any of the other nebulizer and/or nebulizer tube configurations described therein as set forth in [0083]) that may be used for the nebulizer for a desired purpose.
It would be obvious to one of ordinary skill in the art that given the removeable nature of both the nebulizer top/diffuser and nozzle assembly, that an alternate top or nozzle assembly, comprising different physical properties, could be utilized for achieving a different result. Specifically, for example replacing the nozzle assembly of the embodiment disclosed above for claim 1 (FIG. 1 Nebulizer tube 1 as set forth in [0057] and [0064]-[0065]) with the embodiment taught by FIG. 23 and 26 (FIG. 23 and 26 Nebulizer tube 301, 501, wherein the nebulizer tubes of the present invention can include multiple channels, such as the three-channel nebulizer tube 501 depicted in FIGS. 26-28 as set forth in [0077], wherein the variance in where the liquid exists the three channels and contacts the curved impactor would cause a change in droplet size and production given the curved nature of the impactor would cause a difference in the distance between the liquid output and impactor surface), or replacing the top and diffuser of the embodiment above for claim 1 (FIG. 6 Impactor 9, which may be provided as part of the upper housing 2 as set forth in [0066]) with the embodiments of FIG. 49-57 (FIGS. 56-57 Ring feature 840 may be added about a mesa 839, the impactor, to facilitate the creation of a resonant annular channel 841 in the housing 832 The fundamental resonant frequency of the annular channel 841 may be tuned to help generate particles of a preferred size as set forth in [0083]), which may be used with any of the other nebulizer and/or nebulizer tube configurations described therein (As set forth in [0083]). Further, Applicant does not disclose specifically how different the properties between the first top/diffuser and nozzle assembly are, and therefore, even with just slightly different dimensions due to manufacturing or production of the parts within the device would still have at least a very minor effect on the medicine droplet size produced within the nebulizer.
Additionally, Addington teaches wherein the nozzle assembly is interchangeable with a counterpart component having at least one different property, wherein the counterpart component is selected to produce a target droplet size for a medicine disposed in the nebulizer (Addington: FIG. 52 Venturi nozzle 714 is interchangeable together with the suction line 736 and can be configured into different designs so that in conjunction with the controlled pressure and velocity of air as set forth in [0153], the air velocity would have an effect on particle size given the speed in which is hits the diffuser).
Mahoney and Addington are both considered to be analogous to the claimed invention because they are in the same field of Nebulizers. 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 the nozzle assembly of Mahoney to incorporate the teaching of Addington and include wherein the nozzle assembly is interchangeable with a counterpart component having at least one different property, wherein the counterpart component is selected to produce a target droplet size for a medicine disposed in the nebulizer (Addington: FIG. 52 Venturi nozzle 714 is interchangeable together with the suction line 736 and can be configured into different designs so that in conjunction with the controlled pressure and velocity of air as set forth in [0153], the air velocity would have an effect on particle size given the speed in which is hits the diffuser). Doing so would allow a nozzle assembly of a different design to be used in order to achieve a desired effect, for example, velocity of the gas (Addington: As set forth in [0153]).
Further, Denyer teaches that drug delivery apparatuses also typically comprise one or more interchangeable parts, for example interchangeable mouthpieces, interchangeable plunger assemblies and/or interchangeable medication chambers. These interchangeable parts enable a nebulizer to be adapted or customized to best suit the needs of a particular patient. For example, different mouthpieces can be selected depending on the volume of inhalation preferred by a particular user, while different medication chambers can be selected to provide different volumes depending on the drug to be delivered (Denyer: As set forth on page 2 in lines 4-10).
Mahoney and Denyer 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 the individually formed parts of Mahoney to incorporate the teaching of Denyer and include wherein they are interchangeable parts, given that interchangeable parts enable a nebulizer to be adapted or customized to best suit the needs of a particular patient. For example, different mouthpieces can be selected depending on the volume of inhalation preferred by a particular user, while different medication chambers can be selected to provide different volumes depending on the drug to be delivered (Denyer: As set forth on page 2 in lines 4-10). Doing so would enable a nebulizer to be adapted or customized to best suit the needs of a particular patient (Denyer: As set forth on page 2 in lines 4-10), which would those done to provide a target droplet size for a medicine disposed in the nebulizer of Mahoney.
Given that the interchangeable nature of drug delivery apparatus parts is well known in and taught by Addington and Denyer above, it would have been even obvious to one of ordinary skill in the art that the nebulizer top or the nozzle assembly could be replaceable with a counterpart component having at least one different property, wherein the counterpart component is selected to produce a target droplet size for a medicine disposed in the nebulizer as set forth for claim 1.
Regarding claim 2, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Mahoney as modified by Addington and Denyer further teaches, wherein the counterpart component (A part with the interchangeable nature as taught above by Addington and Deneyer) comprises a second diffuser and the at least one different property of the second diffuser is one of a shape, a size, and an offset distance from the nozzle assembly (FIGS. 56-57 Ring feature 840 may be added about a mesa 839, the impactor, to facilitate the creation of a resonant annular channel 841 in the housing 832 The fundamental resonant frequency of the annular channel 841 may be tuned to help generate particles of a preferred size as set forth in [0083], the mesa shape and annular channel of the impactor being a different shape size and distance (the distance being due to either a manufacturing difference or the structure of the ring 840 on the mesa 839) than the original embodiment of FIG. 1-3 and 6 as disclose for claim above).
Regarding claim 3, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Mahoney as modified by Addington and Denyer further teaches, wherein the diffuser projects from the inner surface of the nebulizer top at a first distance from the nozzle assembly (FIG. 1-3 and 6 the nozzle 8 strikes a curved impactor 9, which may be provided as part of the upper housing 2, wherein a sufficiently small spacing is required between the nozzle 8 and impactor 9 to generate a fine mist, the spacing being 10 to 20 thousandths of an inch as set forth in [0066]), and wherein the counterpart component (A part with the interchangeable nature as taught above by Addington and Deneyer) is a second nebulizer top comprising a second diffuser projecting from an inner surface of the second nebulizer top and the at least one different property of second nebulizer top is a second offset distance between the second diffuser and the nozzle assembly (FIGS. 56-57 Ring feature 840 may be added about a mesa 839, the impactor, to facilitate the creation of a resonant annular channel 841 in the housing 832 The fundamental resonant frequency of the annular channel 841 may be tuned to help generate particles of a preferred size as set forth in [0083], the mesa shape and annular channel of the impactor being a different shape size and distance (the distance being due to either a manufacturing difference or the structure of the ring 840 on the mesa 839) than the original embodiment of FIG. 1-3 and 6 as disclose for claim above).
Regarding claim 4, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 3 above.
Mahoney as modified by Addington and Denyer further teaches, wherein a second nozzle assembly is a second counterpart component (A part with the interchangeable nature as taught above by Addington and Deneyer) that replaces the nozzle assembly, the second nozzle assembly having at least one dimension that differs from a dimension of the nozzle assembly (FIG. 23 and 26 Nebulizer tube 301, 501, wherein the nebulizer tubes of the present invention can include multiple channels, such as the three-channel nebulizer tube 501 depicted in FIGS. 26-28 as set forth in [0077]; and Addington: FIG. 52 Venturi nozzle 714 is interchangeable together with the suction line 736 and can be configured into different designs so that in conjunction with the controlled pressure and velocity of air as set forth in [0153], the air velocity would have an effect on particle size given the speed in which is hits the diffuser).
Regarding claim 5, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Mahoney as modified by Addington and Denyer further teaches, wherein the counterpart component (A part with the interchangeable nature as taught above by Addington and Deneyer) is a second nozzle assembly and the at least one different property of the second nozzle assembly is a nozzle outlet of the second nozzle assembly (FIG. 23 and 26 Nebulizer tube 301, 501, wherein the nebulizer tubes of the present invention can include multiple channels, such as the three-channel nebulizer tube 501 depicted in FIGS. 26-28 as set forth in [0077]).
Regarding claim 6, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Mahoney as modified further discloses, wherein the nebulizer top comprises: a vent disposed in a top upper wall of the nebulizer top (FIG. 1-3 Fill port 30 may remain open and may also serve as an exit for nebulized liquid, or the fill port 30 may optionally include a separate funnel or duckbill-shaped cap 31 for insertion into the upper housing 2 to direct the liquid medication into the housing 40 as set forth in [0057]), the vent providing fluid communication between a low pressure chamber (FIG. 12 Throat 43 of the convergent channel 5 will be below that of the local atmospheric pressure as set forth in [0065]) within the nebulizer and an exterior of the nebulizer (FIG. 1-3. Fill port can be used for allowing medicine from an exterior of the nebulizer to enter the housing and then into reservoir 7, that communicates with the throat 32 through the liquid feed channel 6); and an upper chamber disposed above the low-pressure chamber and disposed adjacent to the mouthpiece, wherein the diffuser is disposed between the low pressure chamber and the upper chamber (FIG. 3 The area disposed before the exit port 10 and the mouthpiece being the upper chamber, wherein the diffuser, impactor 9, is located between the throat wherein the convergent channel 5 and liquid channel meet to form the lower chamber; the upper channel being disposed above the low pressure chamber in the way its further downstream the nebulizer, and if one were to hold the nebulizer upright with the mouthpiece facing up, the upper chamber would be disposed above the low pressure chamber).
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Regarding claim 16, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Mahoney as modified 16. The nebulizer of claim 1, wherein the nebulizer is a metered dose nebulizer and the metered dose nebulizer (The nebulizer is delivering a dose of medicine to a patient, the specific does amount being determined by the medicine entering through fill port 30, a does being delivered as set forth by [0006]), comprises a canister port (FIG. 3 Fill port 30) and a valve (FIG. 3 Duckbill-shaped cap 31).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Mahoney (US 20080283049 A1) in view of Addington (WO 2014164175 A2) and Denyer (WO 2011058477 A1) as applied to claim 1, in further view of Alizoti (WO 2021038467 A1).
Regarding claim 7, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Mahoney as modified fails to explicitly disclose, wherein the nebulizer top comprises a sensor module, the sensor module comprising at least one sensor, wherein the at least one sensor is: a pressure sensor (Alizoti: FIG. 43A-B Control module 54 that can be removed, or moved to an uninstalled position as set forth in [00138-[00139]; The control module being a sensor module being that it can measure the pressure in the chamber 48 or flow channel 625 as set forth in [00140]; the sensor assembly 54 may include a housing 202 for a pressure sensor 52 placed on a printed circuit board (PCB), along with a BTLE module 56, a processor (e.g., microprocessor) 60, LED indicator 154, memory, wireless communication capabilities and a battery 58, or solar aided charge, and may communicate with an output component as set forth in [00136]).
Mahoney and Alizoti are both considered to be analogous to the claimed invention because they are in the same field of Nebulizers. 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 the nebulizer of Mahoney to incorporate the teaching of Alizoti and include wherein the nebulizer top comprises a sensor module, the sensor module comprising at least one sensor, wherein the at least one sensor is: a pressure sensor (Alizoti: FIG. 43A-B Control module 54 that can be removed, or moved to an uninstalled position as set forth in [00138]-[00139]; The control module being a sensor module being that it can measure the pressure in the chamber 48 or flow channel 625 as set forth in [00140]; the sensor assembly 54 may include a housing 202 for a pressure sensor 52 placed on a printed circuit board (PCB), along with a BTLE module 56, a processor (e.g., microprocessor) 60, LED indicator 154, memory, wireless communication capabilities and a battery 58, or solar aided charge, and may communicate with an output component as set forth in [00136]). Doing so would allow the data and information gathered regarding the performance of the OPEP device to be archived and analyzed to provide an overview of the user’s progress which may be made available to health care providers and insurers, for example, to monitor treatment adherence (Alizoti: As set forth in [0004]), as well as allows for a configuration of the sensor module in which it can be removed so that the device may be cleaned without damaging the electronic components (Alizoti: As set forth in [00139]).
Regarding claim 8, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 7 above.
Mahoney as modified by Alizoti further teaches, wherein the sensor module is detachably coupled to the nebulizer (Alizoti: FIG. 43A-B Control module 54 that can be removed, or moved to an uninstalled position as set forth in [00138]-[00139]), and wherein the sensor module further comprises a processor, a storage device that stores data collected by the at least one sensor, and a transmitter that transmits the data to an external computing device (Alizoti: The sensor assembly 54 may include a housing 202 for a pressure sensor 52 placed on a printed circuit board (PCB), along with a BTLE module 56, a processor (e.g., microprocessor) 60, LED indicator 154, memory, wireless communication capabilities and a battery 58, or solar aided charge, and may communicate with an output component as set forth in [00136]).
Claims 7 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mahoney (US 20080283049 A1) in view of Addington (WO 2014164175 A2) and Denyer (WO 2011058477 A1) as applied to claim 1, in further view of Alizoti (WO 2021038467 A1) and Costella (US 20180161531 A1).
Regarding claim 7, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Mahoney as modified fails to explicitly disclose, wherein the nebulizer top comprises a sensor module, the sensor module comprising at least one sensor, wherein the at least one sensor is: a pressure sensor (Alizoti: FIG. 43A-B Control module 54 that can be removed, or moved to an uninstalled position as set forth in [00138-[00139]; The control module being a sensor module being that it can measure the pressure in the chamber 48 or flow channel 625 as set forth in [00140]; the sensor assembly 54 may include a housing 202 for a pressure sensor 52 placed on a printed circuit board (PCB), along with a BTLE module 56, a processor (e.g., microprocessor) 60, LED indicator 154, memory, wireless communication capabilities and a battery 58, or solar aided charge, and may communicate with an output component as set forth in [00136]).
Mahoney and Alizoti are both considered to be analogous to the claimed invention because they are in the same field of Nebulizers. 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 the nebulizer of Mahoney to incorporate the teaching of Alizoti and include wherein the nebulizer top comprises a sensor module, the sensor module comprising at least one sensor, wherein the at least one sensor is: a pressure sensor (Alizoti: FIG. 43A-B Control module 54 that can be removed, or moved to an uninstalled position as set forth in [00138]-[00139]; The control module being a sensor module being that it can measure the pressure in the chamber 48 or flow channel 625 as set forth in [00140]; the sensor assembly 54 may include a housing 202 for a pressure sensor 52 placed on a printed circuit board (PCB), along with a BTLE module 56, a processor (e.g., microprocessor) 60, LED indicator 154, memory, wireless communication capabilities and a battery 58, or solar aided charge, and may communicate with an output component as set forth in [00136]). Doing so would allow the data and information gathered regarding the performance of the OPEP device to be archived and analyzed to provide an overview of the user’s progress which may be made available to health care providers and insurers, for example, to monitor treatment adherence (Alizoti: As set forth in [0004]), as well as allows for a configuration of the sensor module in which it can be removed so that the device may be cleaned without damaging the electronic components (Alizoti: As set forth in [00139]).
Mahoney as modified fails to explicitly disclose, wherein the sensor is a humidity sensor.
However, Costella teaches, wherein a nebulizer comprises a humidity sensor (Costella: FIGS. 19-20 A humidity sensor 166 is placed within the nebulizer, in the aerosol pathway 112, the sensor 166 is preferably calibrated before each treatment for the relative humidity of the environment it is being used in and the source of the compressed air. This calibration could be performed using a second, external humidity sensor as set forth in [0188], the sensor data being input to a computing device as set forth in [0147]).
Mahoney and Costella are both considered to be analogous to the claimed invention because they are in the same field of Nebulizers. 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 the sensor module of Mahoney as modified to incorporate the teaching of Costella and include wherein the nebulizer comprises a humidity sensor (Costella: FIGS. 19-20 A humidity sensor 166 is placed within the nebulizer, in the aerosol pathway 112, the sensor 166 is preferably calibrated before each treatment for the relative humidity of the environment it is being used in and the source of the compressed air. This calibration could be performed using a second, external humidity sensor as set forth in [0188], the sensor data being input to a computing device as set forth in [0147]). Doing so would allow for the data to be viewed at a later time/date by the user or healthcare provider to track treatment adherence (Costella: As set forth in [0147] and [0164]), as all as to ensure the humidity sensor is properly calibrated (Costella: As set forth in [0188]).
Mahoney as modified fails to explicitly disclose, wherein the sensor is a temperature sensor.
However, Costella teaches, wherein a nebulizer comprises a temperature sensor (Costella: FIGS. 13A-E, in one embodiment, a temperature sensor 168 is placed within the nebulizer, in the aerosol pathway 112 as set forth in [0189], wherein multiple temperature sensors 168, 170 (see FIG. 13E) may be used to measure relative temperature changes to the external environment in order to improve the accuracy of the system and set reference temperatures as set forth in [0191]).
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 the sensor module of Mahoney as modified to incorporate the teaching of Costella and include wherein the nebulizer comprises a temperature sensor (Costella: FIGS. 13A-E, in one embodiment, a temperature sensor 168 is placed within the nebulizer, in the aerosol pathway 112 as set forth in [0189], wherein multiple temperature sensors 168, 170 (see FIG. 13E) may be used to measure relative temperature changes to the external environment in order to improve the accuracy of the system and set reference temperatures as set forth in [0191]). Doing so would allow for the data to be viewed at a later time/date by the user or healthcare provider to track treatment adherence (Costella: As set forth in [0147] and [0164]), as all as to ensure the temperature sensor is properly calibrated (Costella: As set forth in [0191]).
Mahoney as modified fails to explicitly disclose, wherein the sensor is an optical bio-sensor.
However, Costella teaches, wherein a nebulizer comprises an optical bio-sensor (FIG. 28A-B White light source 108 is positioned adjacent to a detector 110 capable of identifying the color spectrum of the detected light, wherein a change in the wavelengths detected by the sensor indicates that aerosol is present, and may identify the medication that is being aerosolized and the concentration thereof. As set forth in [0173]).
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 the sensor module of Mahoney as modified to incorporate the teaching of Costella and include wherein the nebulizer comprises an optical bio-sensor (FIG. 28A-B White light source 108 is positioned adjacent to a detector 110 capable of identifying the color spectrum of the detected light, wherein a change in the wavelengths detected by the sensor indicates that aerosol is present, and may identify the medication that is being aerosolized and the concentration thereof. As set forth in [0173]). Doing so would allow for the data to be viewed at a later time/date by the user or healthcare provider to track treatment adherence (Costella: As set forth in [0147] and [0164]), in this case, including being able to identify the medication that is being delivered and the concentration thereof (Costella: As set forth in [0173]).
Mahoney as modified fails to explicitly disclose, wherein the sensor is a medicine level sensor (Costella: FIG. 88 A pressure sensor 290 may be used to measure the volume of fluid in the bowl, wherein as the medication is aerosolized the amount of liquid above the sensor decreases and the sensor registers a lower pressure as set forth in [0285]).
However, Costella teaches, wherein a nebulizer comprises a medicine level sensor.
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 the sensor module of Mahoney as modified to incorporate the teaching of Costella and include wherein the nebulizer comprises a medicine level sensor (Costella: FIG. 88 A pressure sensor 290 may be used to measure the volume of fluid in the bowl, wherein as the medication is aerosolized the amount of liquid above the sensor decreases and the sensor registers a lower pressure as set forth in [0285]). Doing so would allow for the data to be viewed at a later time/date by the user or healthcare provider to track treatment adherence (Costella: As set forth in [0147] and [0164]), in this case, including how much medicine was nebulized.
Mahoney as modified fails to explicitly disclose, wherein the sensor is a flow sensor.
However, Costella teaches, wherein a nebulizer comprises a flow sensor (Costella: FIG. 105 The sensor 330 detect inhalation and exhalation flow, breathing patterns, and flow rates as set forth in [0152]).
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 the sensor module of Mahoney as modified to incorporate the teaching of Costella and include wherein the nebulizer comprises a flow sensor (Costella: FIG. 105 The sensor 330 detect inhalation and exhalation flow, breathing patterns, and flow rates as set forth in [0152]). Doing so would allow for the data to be viewed at a later time/date by the user or healthcare provider to track treatment adherence (Costella: As set forth in [0147] and [0164]).
Regarding claim 9, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 7 above.
Mahoney as modified by Alizoti and Costella further teaches, wherein the humidity sensor is an internal humidity sensor that measures an internal humidity within the nebulizer, and wherein the sensor module further comprises an external humidity sensor that measures an external humidity outside the nebulizer (Costella: FIGS. 19-20 A humidity sensor 166 is placed within the nebulizer, in the aerosol pathway 112, the sensor 166 is preferably calibrated before each treatment for the relative humidity of the environment it is being used in and the source of the compressed air. This calibration could be performed using a second, external humidity sensor as set forth in [0188], the sensor data being input to a computing device as set forth in [0147]).
Regarding claim 10, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 7 above.
Mahoney as modified by Alizoti and Costella further teaches, wherein the temperature sensor is configured to measure one of a temperature of nebulized medicine and an ambient temperature (Costella: FIGS. 13A-E, in one embodiment, a temperature sensor 168 is placed within the nebulizer, in the aerosol pathway 112 as set forth in [0189], wherein multiple temperature sensors 168, 170 (see FIG. 13E) may be used to measure relative temperature changes to the external environment in order to improve the accuracy of the system and set reference temperatures as set forth in [0191]).
Regarding claim 11, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 7 above.
Mahoney as modified by Alizoti and Costella further teaches, wherein the optical biosensor is configured for colorimetry detection (FIG. 28A-B White light source 108 is positioned adjacent to a detector 110 capable of identifying the color spectrum of the detected light, wherein a change in the wavelengths detected by the sensor indicates that aerosol is present, and may identify the medication that is being aerosolized and the concentration thereof. As set forth in [0173]).
Regarding claim 12, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 7 above.
Mahoney as modified by Alizoti and Costella further teaches, wherein the sensor module is used to determine an uptake of the medicine by a patient (Costella: FIG. 88 A pressure sensor 290 may be used to measure the volume of fluid in the bowl, wherein as the medication is aerosolized the amount of liquid above the sensor decreases and the sensor registers a lower pressure as set forth in [0285]).
Regarding claim 13, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 7 above.
Mahoney as modified by Alizoti and Costella further teaches, wherein the sensor module is used to determine a pulmonary function of a patient (Costella: FIG. 105 The sensor 330 detect inhalation and exhalation flow, breathing patterns, and flow rates as set forth in [0152], all of which would be a determining factor determining pulmonary function).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Mahoney (US 20080283049 A1) in view of Addington (WO 2014164175 A2) and Denyer (WO 2011058477 A1), in further view of Alizoti (WO 2021038467 A1) as applied to claims 1 and 7, in further view of Smaldone (WO 2019236899 A1).
Regarding claim 14, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 7 above.
Mahoney as modified fails to explicitly disclose, wherein the sensor module communicates with a ventilator.
However, Smaldone teaches, wherein a sensor module communicates with a ventilator (Smaldone: A pressure sensor interposed between the nebulizer and the ventilator, wherein the pressure sensor controls a pressurized air supply to the nebulizer required for nebulization to occur as set forth in [0011]) .
Mahoney and Smaldone are both considered to be analogous to the claimed invention because they are in the same field of Nebulizers. 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 the sensor module and breathing circuit configuration of Mahoney as modified to incorporate the teaching of Smaldone and include wherein the sensor sensor module communicates with a ventilator (Smaldone: A pressure sensor interposed between the nebulizer and the ventilator, wherein the pressure sensor controls a pressurized air supply to the nebulizer required for nebulization to occur as set forth in [0011]).
Regarding claim 15, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Mahoney as modified further discloses, wherein the nebulizer is coupled to a compressed air source (As set forth in [0057])
Mahoney as modified fails to explicitly disclose, wherein the nebulizer is a ventilator nebulizer coupled to a ventilator.
However, Smaldone teaches wherein the nebulizer is a ventilator nebulizer coupled to a ventilator (Smaldone: As set forth in [0011]).
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 the compressed air source of Mahoney as modified to incorporate the teaching of Smaldone and include wherein the nebulizer is a ventilator nebulizer coupled to a ventilator (Smaldone: As set forth in [0011]). Doing so would make it so a patient being ventilated could be administer nebulized drugs (Smaldone: As set forth in [0003] and [0011]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Mahoney (US 20080283049 A1) in view of Alizoti (WO 2021038467 A1).
Regarding claim 17, Mahoney discloses a method of using a nebulizer (FIG. 1-3 Nebulizer 100 as set forth in [0057]), the method comprising: providing a nebulizer top (FIG. 1-3 Upper housing 2 as set forth in [0057]) and a nebulizer bottom (FIG. 1-3 Lower housing 3 as set forth in [0057]); inserting a nozzle assembly between the nebulizer top and the nebulizer bottom (FIG. 1 Nebulizer tube 1 as set forth in [0057] and [0064]-[0065]) and coupling the nebulizer top to the nebulizer bottom with the nozzle assembly located therebetween (FIG. 1-3 Nebulizer tube 1 that mates with a complementary positioning feature 11 of the lower housing 3 to locate the nebulizer tube 1 within the housing 40 and mates with an nozzle capture feature 15 of the upper housing 2 to stabilize the tube 1 within the nebulizer 100, FIGS. 8-10 as set forth in [0066]); coupling a gas supply to a nozzle inlet of the nozzle assembly (Nebulizer is connected to a compressed air source as set forth in [0057]); providing nebulized medicine that flows from a mouthpiece of the nebulizer (FIG. 1-3 Exit port 10 of the nebulizer 100 permits mist flow of the liquid medication as set forth in [0060]);
Mahoney fails to explicitly disclose, collecting, with a sensor of a sensor module coupled to the nebulizer, data associated with operation of the nebulizer; and providing the data to a processor that analyzes the data and generates a report associated with the operation of the nebulizer.
However, Alizoti teaches collecting, with a sensor of a sensor module coupled to the nebulizer, data associated with operation of the nebulizer; and providing the data to a processor that analyzes the data and generates a report associated with the operation of the nebulizer (Alizoti: FIG. 43A-B Control module 54 that can be removed, or moved to an uninstalled position as set forth in [00138]-[00139]; The control module being a sensor module being that it can measure the pressure in the chamber 48 or flow channel 625 as set forth in [00140]; the sensor assembly 54 may include a housing 202 for a pressure sensor 52 placed on a printed circuit board (PCB), along with a BTLE module 56, a processor (e.g., microprocessor) 60, LED indicator 154, memory, wireless communication capabilities and a battery 58, or solar aided charge, and may communicate with an output component as set forth in [00136]; the data and report associated with the operation of the nebulizer being the sensor data communicated with an output component).
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 the nebulizer of Mahoney to incorporate the teaching of Alizoti and include wherein the operation of the nebulizer comprises collecting, with a sensor of a sensor module coupled to the nebulizer, data associated with operation of the nebulizer; and providing the data to a processor that analyzes the data and generates a report associated with the operation of the nebulizer (Alizoti: FIG. 43A-B Control module 54 that can be removed, or moved to an uninstalled position as set forth in [00138]-[00139]; The control module being a sensor module being that it can measure the pressure in the chamber 48 or flow channel 625 as set forth in [00140]; the sensor assembly 54 may include a housing 202 for a pressure sensor 52 placed on a printed circuit board (PCB), along with a BTLE module 56, a processor (e.g., microprocessor) 60, LED indicator 154, memory, wireless communication capabilities and a battery 58, or solar aided charge, and may communicate with an output component as set forth in [00136]; the data and report associated with the operation of the nebulizer being the sensor data communicated with an output component).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mahoney (US 20080283049 A1) in view of Alizoti (WO 2021038467 A1) as applied to claim 17, in further view of Costella (US 20180161531 A1).
Regarding claim 18, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 17 above.
Mahoney as modified by Alizoti further teaches, wherein the processor is located within the sensor module and wherein the sensor is at least one sensor, wherein the at least one sensor is: a pressure sensor (Alizoti: FIG. 43A-B Control module 54 that can be removed, or moved to an uninstalled position as set forth in [00138]-[00139]; The control module being a sensor module being that it can measure the pressure in the chamber 48 or flow channel 625 as set forth in [00140]; the sensor assembly 54 may include a housing 202 for a pressure sensor 52 placed on a printed circuit board (PCB), along with a BTLE module 56, a processor (e.g., microprocessor) 60, LED indicator 154, memory, wireless communication capabilities and a battery 58, or solar aided charge, and may communicate with an output component as set forth in [00136]).
Mahoney as modified fails to explicitly disclose, wherein the sensor is a humidity sensor.
However, Costella teaches, wherein a nebulizer comprises a humidity sensor (Costella: FIGS. 19-20 A humidity sensor 166 is placed within the nebulizer, in the aerosol pathway 112, the sensor 166 is preferably calibrated before each treatment for the relative humidity of the environment it is being used in and the source of the compressed air. This calibration could be performed using a second, external humidity sensor as set forth in [0188], the sensor data being input to a computing device as set forth in [0147]).
Mahoney and Costella are both considered to be analogous to the claimed invention because they are in the same field of Nebulizers. 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 the sensor module of Mahoney as modified to incorporate the teaching of Costella and include wherein the nebulizer comprises a humidity sensor (Costella: FIGS. 19-20 A humidity sensor 166 is placed within the nebulizer, in the aerosol pathway 112, the sensor 166 is preferably calibrated before each treatment for the relative humidity of the environment it is being used in and the source of the compressed air. This calibration could be performed using a second, external humidity sensor as set forth in [0188], the sensor data being input to a computing device as set forth in [0147]). Doing so would allow for the data to be viewed at a later time/date by the user or healthcare provider to track treatment adherence (Costella: As set forth in [0147] and [0164]), as all as to ensure the humidity sensor is properly calibrated (Costella: As set forth in [0188]).
Mahoney as modified fails to explicitly disclose, wherein the sensor is a temperature sensor.
However, Costella teaches, wherein a nebulizer comprises a temperature sensor (Costella: FIGS. 13A-E, in one embodiment, a temperature sensor 168 is placed within the nebulizer, in the aerosol pathway 112 as set forth in [0189], wherein multiple temperature sensors 168, 170 (see FIG. 13E) may be used to measure relative temperature changes to the external environment in order to improve the accuracy of the system and set reference temperatures as set forth in [0191]).
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 the sensor module of Mahoney as modified to incorporate the teaching of Costella and include wherein the nebulizer comprises a temperature sensor (Costella: FIGS. 13A-E, in one embodiment, a temperature sensor 168 is placed within the nebulizer, in the aerosol pathway 112 as set forth in [0189], wherein multiple temperature sensors 168, 170 (see FIG. 13E) may be used to measure relative temperature changes to the external environment in order to improve the accuracy of the system and set reference temperatures as set forth in [0191]). Doing so would allow for the data to be viewed at a later time/date by the user or healthcare provider to track treatment adherence (Costella: As set forth in [0147] and [0164]), as all as to ensure the temperature sensor is properly calibrated (Costella: As set forth in [0191]).
Regarding claim 19, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 18 above.
Mahoney as modified by Alizoti and Costella further teaches, wherein the humidity sensor is an internal humidity sensor that measures an internal humidity within the nebulizer, and wherein the sensor module further comprises an external humidity sensor that measures an external humidity outside the nebulizer (Costella: FIGS. 19-20 A humidity sensor 166 is placed within the nebulizer, in the aerosol pathway 112, the sensor 166 is preferably calibrated before each treatment for the relative humidity of the environment it is being used in and the source of the compressed air. This calibration could be performed using a second, external humidity sensor as set forth in [0188], the sensor data being input to a computing device as set forth in [0147]).
Regarding claim 20, Mahoney as modified discloses the claimed invention substantially as claimed as set forth for claim 18 above.
Mahoney as modified by Alizoti and Costella further teaches, wherein the temperature sensor is configured to measure one of a temperature of nebulized medicine and an ambient temperature (Costella: FIGS. 13A-E, in one embodiment, a temperature sensor 168 is placed within the nebulizer, in the aerosol pathway 112 as set forth in [0189], wherein multiple temperature sensors 168, 170 (see FIG. 13E) may be used to measure relative temperature changes to the external environment in order to improve the accuracy of the system and set reference temperatures as set forth in [0191]).
Conclusion
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.
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/KEIRA EILEEN CALLISON/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
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