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 § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5, 8, 10-13, 30, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,522,385 to Lloyd (“Lloyd”) in view of U.S. Patent Publication No. 2019/0083720 to LEADLEY et al. (“Leadley”).
Regarding claim 1, Lloyd teaches a nebulizer device (Fig. 1) comprising an aerosol generator (42) mounted in a housing (30), the aerosol generator configured to generate an aerosol by aerosolizing a liquid (abstract), a controller (microprocessor 26), and a mouthpiece (30) defined by the housing including a flow path (29), wherein the controller is configured to cause the device to deliver an active agent via the mouthpiece (column 13, lines 47-55) but does not teach the protrusions.
Leadley teaches a plurality of protrusions (760, Figs. 12A-12B) disposed within the flow path (740), the plurality of protrusions extending into the flow path from a flat internal surface (432) of the flow path and extending along the flat internal surface of the flow path within a plane perpendicular to the flow path to narrow the flow path and enhance turbulent flow of air (Fig. 12B) within the flow path. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flow path of Lloyd to include protrusions as taught by Leadley to provide and increased degree of airflow modification/turbulence ([0082]).
Regarding claim 2, Lloyd and Leadley teach the device as claimed in claim 1 as shown above, Lloyd further teaching the aerosol generator delivers droplets for which a majority fraction has a size greater than 10µm (column 8, lines 52-53, 0.5 to 12 microns).
Regarding claim 3, Lloyd and Leadley teach the device as claimed in claim 1 as shown above, Lloyd further teaching an aperture plate (14, the membrane is a polymeric plastic, column 14, lines 66-67) and a vibration actuator (42) for vibrating the aperture plate at a frequency for aerosolization of the liquid, wherein the aperture plate has apertures with an exit diameter in excess of 5.0 µm (column 8, lines 54-56, 6.0 microns)
Regarding claim 5, Lloyd and Leadley teach the device as claimed in claim 1 as shown above, Lloyd further teaching the housing being capable of directing an exhalation flow towards the aerosol generator for entrainment of aerosol (via 29, Fig. 1).
Regarding claim 8, Lloyd and Leadley teach the device as claimed in claim 1 as shown above, Lloyd further teaching the controller is configured to operate such that operation of the aerosol generator is responsive to the start of breath inhalation (column 16, lines 1-10).
Regarding claim 10, Lloyd and Leadley teach the device as claimed in claim 1 as shown above, Lloyd further teaching a detector (flow sensor 31) for detecting inhalation.
Regarding claim 11, Lloyd and Leadley teach the device as claimed in claim 10 as shown above, Lloyd further teaching the detector comprises one or more of temperature, pressure, flow or auditory sensors (flow sensor 31).
Regarding claim 12, Lloyd and Leadley teach the device as claimed in claim 11 as shown above, Lloyd further teaching the detector comprises a pressure sensor (37).
Regarding claim 13, Lloyd and Leadley teach the device as claimed in claim 12 as shown above, Lloyd further teaching the pressure sensor is mounted upstream of the aerosol generator (since air enters through 41, sensor 37 is upstream from 42) at or adjacent an outlet of the mouthpiece (30, Fig. 1).
Regarding claim 30, Lloyd teaches a nebulizer device (Fig. 1) comprising a housing (30), an aerosol generator (42) mounted in the housing and configured to generate an aerosol (abstract), a mouthpiece (30) defined by the housing including a flow path (29), and a controller (microprocessor 26) configured to cause the device to deliver the aerosol generated by aerosol generator via the mouthpiece but does not teach the ribs.
Leadley teaches a plurality of ribs disposed within a flow path, each rib of the plurality of ribs extending into the flow path from a flat internal surface of the flow path to narrow the flow path and extending entirely around the flow path to enhance turbulent flow of air within the flow path ([0082], protrusions 760 can also be formed as closed rings which would extent entirely around the flow path). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flow path of Lloyd to have ribs as taught by Leadley to provide an increased degree of airflow/turbulence ([0082]).
Regarding claim 32, Lloyd and Leadley teach the nebulizer device as claimed in claim 1 as shown above, Leadley further teaching wherein each protrusion of the plurality of protrusions extends entirely around the flow path ([0082], the protrusions can alternatively be formed as closed rings, the closed rings extending entirely around the flow path by virtue of being shaped as closed rings).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lloyd in view Leadley as applied to claim 2 above, and further in view of U.S. Patent Publication No. 2002/0121274 to Borland et al., (“Borland”).
Regarding claim 4, Lloyd and Leadley teach the device as claim in claim 2 as shown above, but do not mention the majority fraction, although majority fractions can be considered a mere results effective variable based on aperture size, flow rate, humidity, temperature, and various other factors.
In any case, Borland has been cited to explicitly teach a majority fraction of 75% ([0024]) using a similar aerosol generator having the same droplet size ([0024], 10 microns). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had a 75% majority fraction for the aerosol of Lloyd as taught be Borland as the provision of droplet size consistency benefits the patients since specific droplet sizes are optimal for particular treatment areas.
Claims 15, 21-24, 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Lloyd in view Leadley as applied to claims 1 and 10 above, and further in view of U.S. Patent No. 5,080,093 to Raabe et al. (“Raabe”).
Regarding claim 15, Lloyd and Leadley teach the device as claimed in claim 10 as shown above, Lloyd further teaching a controller configured to control a method of operation including the steps of providing the liquid containing the active agent (column 11, lines 53-57), aerosolising the liquid to generate the aerosol comprising droplets having an average mean diameter of greater than 10µm (column 8, lines 52-53, 0.5 to 12 microns), delivering the aerosol into the buccal cavity (the aerosol passes into the mouth through the mouthpiece), but does not teach starting and stopping relative to inhalation.
Raabe teaches starting aerosol generation after the end of breath inhalation (see claim 3 of Raabe, aerosol generation starts at exhalation, i.e., after the end of inhalation) and stopping aerosol generation before the start of breath inhalation (see claim 3 of Raabe, aerosol generation is synchronized with exhalation, therefore it ends before inhalation begins) in a similar type of nebulizer. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lloyd to operate the aerosol generator after the end of breath inhalation and stopping aerosol generation before the start of breath inhalation, i.e., during exhalation, as taught by Raabe, for the expected result of providing an aerosol to a patient. Raabe teaches aerosol generation during either inhalation or exhalation (column 3, lines 35-45) in order to provide aerosol to the patient to suit various needs and/or applications including ones that may require the supply of aerosol during exhalation, which would including starting after the end or stopping before the start of inhalation.
Regarding claim 21, Lloyd and Leadley teach a method for administration of an active therapeutic or non-therapeutic agent into a buccal cavity (mouthpiece 30 indicates oral dispersion which would include the buccal cavity), the method being performed by the device of claim 1 as shown above, Lloyd further teaching the steps of providing a liquid containing an active substance (column 11, lines 53-57), aerosolising the liquid to provide an aerosol comprising droplets having an average mean diameter of greater than 10 µm (column 8, lines 52-53, 0.5 to 12 microns), delivering the aerosol into the buccal cavity (the aerosol passes into the mouth through the mouthpiece), but does not teach starting aerosol generation after the end of breath inhalation and stopping aerosol generation before the start of breath inhalation.
Raabe teaches starting aerosol generation after the end of breath inhalation (see claim 3 of Raabe, aerosol generation starts at exhalation, i.e., after the end of inhalation) and stopping aerosol generation before the start of breath inhalation (see claim 3 of Raabe, aerosol generation is synchronized with inhalation, therefore it ends before inhalation begins) in a similar type of nebulizer. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method performed by Lloyd and Leadley to operate the aerosol generator after the end of breath inhalation and stopping aerosol generation before the start of breath inhalation, i.e., during exhalation, as taught by Raabe, for the expected result of providing an aerosol to a patient. Raabe teaches aerosol generation during either inhalation or exhalation (column 3, lines 35-45) in order to provide aerosol to the patient to suit various needs and/or applications including ones that may require the supply of aerosol during exhalation, which would including starting after the end or stopping before the start of inhalation.
Regarding claim 22, Lloyd, Leadley, and Raabe teach the method as claimed in claim 21 a shown above, Raabe further teaching detecting the end of breath inhalation (inhalation, including the beginning and end thereof, corresponds to the signal from the electrical signal source which actuates the nebulizer (column 3, lines 21-32), and starting aerosol generation based on the detection of the end of breath inhalation (once inhalation finishes, the nebulizer valve 6 is switched by the signal source to switch “on” the nebulizer, in the embodiment where the signals are reversed, column 3, lines 35-45).
Regarding claim 23, Lloyd, Leadley, and Raabe teach the method as claimed in claim 21 as shown above, Raabe further teaching detecting the start of breath inhalation and stopping aerosol generation based on the detection of the start of breath inhalation (in the embodiment where the signals are reversed, column 3, lines 35-45, the start of breath inhalation would correspond to the “off” position where no aerosol is generated).
Regarding claim 24, Lloyd, Leadley, and Raabe teach the method as claimed in claim 21 as shown above, Raabe further teaching monitoring a breathing profile of a patient (output from signal source 72 that corresponds to breathing cycle, column 3, lines 21-32) and controlling the aerosol generation such that aerosol is generated only when the patient is not inhaling (in the embodiment where the signals are reversed, column 3, lines 35-45, the aerosol is generated during exhalation, i.e., not inhalation, also see claim 3 of Raabe).
Regarding claim 26, Lloyd, Leadley, and Raabe teach the method as claimed in claim 21 as shown above, Raabe further teaching detecting exhalation and starting aerosol generation based on the detection of the start of exhalation (see claim 3 of Raabe).
Regarding claim 27, Lloyd, Leadley, and Raabe teach the method as claimed in claim 21 as shown above, Raabe further teaching detecting exhalation and stopping aerosol generation based on the detection of the end of exhalation (see claim 3 of Raabe).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Lloyd and Leadley as applied to claim 13 above, and further in view of U.S. Patent No. 6,845,770 to Klimowicz et al., (“Klimowicz”) and U.S. Patent Publication No. 2018/0110939 to Lanzkowsky.
Regarding claim 14, Lloyd and Leadley teach a device as claimed in claim 13 as shown above, Lloyd further teaching the device comprises, in order from proximal to distal towards the mouth in use (Fig. 1): the aerosol generator (42) and a volume defined by the housing (29), and Leadley teaching the plurality of ribs, but do not show the position of the sensor and the outlet mesh.
Klimowicz teaches a flow or pressure sensor (32, Fig. 1) positioned before an aerosol generator (20). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lloyd to position the sensor before the aerosol generator as taught by Klimowicz in order to optimize placement of the sensor relative to the mouthpiece and inlet (column 9, lines 41-42). Additionally or in the alternative, It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to position the sensor before the before the aerosol generator since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed configuration would not perform differently than the prior art device, In re Japikse, 86 USPQ 70 and since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art, In re Einstein, 8 USPQ 167.
Lanzkowsky teaches an outlet mesh (cover screen 602, [0112], which can be employed at both ends of mouthpiece 203, Fig. 6). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mouthpiece of Lloyd with the outlet mesh as taught by Lanzkowsky in order to prevent the inhalation of unwanted materials ([0112]).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Lloyd, Leadley, and Raabe as applied to claim 21 above, and further in view of U.S. Patent Publication No. 2017/0368282 to Knoch.
Regarding claim 25, Lloyd, Leadley, and Raabe teach the method as claimed in claim 21 as shown above, Raabe also teaching monitoring a breathing profile of the patient (output from signal source 72 that corresponds to breathing cycle, column 3, lines 21-32), but do not teach stopping generation of aerosol in the event of irregular inhalation.
Knoch teaches stopping generation of aerosol in the event of irregular inhalation ([0090]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lloyd, Leadley, and Raabe to stop in the event of an irregular inhalation as taught by Knoch in order to provide particularly efficient aerosol treatment with a high aerosol dosage precision and consistency ([0090]) when breathing irregularities arise.
Claims 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Lloyd, Leadley, and Raabe as applied to claim 21 above, and further in view of U.S. Patent No. 9,289,792 Hogan et al. (“Hogan”).
Regarding claims 28 and 29, Lloyd, Leadley, and Raabe teach the method as claimed in claim 21 as shown above, but do not teach the flow rates.
Hogan teaches providing a flow rate of aerosol in excess of 1mL/min and below 5 mL/min and in the range of 2mL/min and 4mL/min (2 ml/min, column 5, lines 40-41). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a 2 ml/min flow rate in the device of Lloyd, Leadley, and Raabe as taught by Hogan, for the predictable result of providing an optimal flow rate to meet the particular needs of the patient as prescribed by a practitioner.
Claims 1, 16, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 9,289,792 to Hogan et al. (“Hogan”) in view of U.S. Patent Publication No. 2007/0267010 to Fink et al. (“Fink”) and Leadley.
Regarding claim 1, Hogan teaches a nebulizer device (Fig. 3) comprising an aerosol generator (Fig. 4) mounted in a housing (29), the aerosol generator configured to generate an aerosol by aerosolizing a liquid (column 4, lines 1-7), a controller (conducting pins 10 and 11 can act ask a controller by conveying power since no function has been attributed to the controller in the claim), but does not explicitly disclose a mouthpiece and a plurality of protrusions, although the bottom of housing 29 could be considered a mouthpiece given the broadest reasonable interpretation.
Fink teaches a mouthpiece (left end of 492, Fig. 4D) defined by a housing (492) including a flow path (flow path of 492) attached to a highly analogous nebulizer device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Hogan to include a mouthpiece as taught by Fink for the expected result of providing an aerosol to a patient. Nebulizers such as the one in Hogan are used to provide aerosolized medicament to patients, Fink merely shows one example of a system where such a nebulizer is being used to provide medicament to the mouth of a patient. Once combined the controller of the device of Hogan and Fink would be configured to (or capable of) causing the device to deliver an active agent via the mouthpiece.
Leadley teaches a plurality of protrusions (760, Figs. 12A-12B) disposed within the flow path (740), the plurality of protrusions extending into the flow path from a flat internal surface (432) of the flow path and extending along the flat internal surface of the flow path within a plane perpendicular to the flow path to narrow the flow path and enhance turbulent flow of air (Fig. 12B) within the flow path. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flow path of Hogan and Fink to include protrusions as taught by Leadley to provide and increased degree of airflow modification/turbulence ([0082]).
Regarding claim 16, Hogan, Fink, and Leadley teach the device as claimed in claim 1 as shown above, Hogan further teaching the controller is adapted to vary drive voltage for the aperture plate in order to achieve a desired droplet size (column 6, lines 38-46).
Regarding claim 19, Hogan, Fink, and Leadley teach the device as claimed in claim 1 as shown above, Hogan further teaching the controller and the aerosol generator are configured to provide flow rates of aerosol in excess of 1mL/min and below 5 mL/min (2 ml/min, column 5, lines 40-41).
Regarding claim 20, Hogan, Fink, and Leadley teach the device of claim 19 as shown above, Hogan further teaching the flow rate is in the range of 2mL/min and 4mL/min (2 ml/min, column 5, lines 40-41).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Lloyd in view of U.S. Patent No. 4,955,371 to Zamba et al. (“Zamba”), and Leadley, and/or in the alternative over Lloyd in view of Zamba, Leadley, and U.S. Patent No. 4,819,629 to Jonson.
Regarding claim 31, Lloyd teaches a nebulizer device (Fig. 1) comprising a housing (30), a mouthpiece (30) defined by the housing including a flow path (29), an aerosol generator (42) mounted in the housing and including an outlet (outlet of 42), the aerosol generator configured to generate an aerosol and provide the aerosol to the flow path via the outlet (column 14, lines 41-52), and a controller (microprocessor 26) configured to cause the device to deliver the aerosol generated by the aerosol generator via the mouthpiece, but does not teach the protrusions and the outlet direction.
Zamba teaches a plurality of protrusions (12, Fig. 2) disposed within a flow path, the plurality of protrusions extending into the flow path from a flat internal surface (7) of the flow path to narrow the flow path and enhance turbulent flow of air within the flow path, the plurality of protrusions including a protrusion (12) extending along the flat internal surface (7) of the flow path in a direction parallel to the flow path (Fig. 2). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flow path of Lloyd to include protrusions as taught by Zamba to create turbulence to assist in the atomization of a sprayed medicament (column 6, lines 60-64).
Leadley teaches a protrusion (760, Fig. 12B) extending along the flat internal surface of the flow path within a plane perpendicular to the flow path (740). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flow path of Lloyd to have a protrusion as taught by Leadley to provide an increased degree of airflow/turbulence ([0082]).
Regarding the outlet direction, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to position the outlet of the outlet to perpendicular to the flow path since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed configuration would not perform differently than the prior art device, In re Japikse, 86 USPQ 70. In in the instant case, a perpendicular outlet direction would not perform differently than an outlet direction being a non-perpendicular.
Alternatively, Jonson teaches an outlet direction of an outlet (71, Fig. 3) of an aerosol generator (7) being perpendicular to a flow path (51). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lloyd to have an outlet positioned perpendicular to a flow path to yield the predictable result of providing aerosolized particles to a flow path.
Response to Arguments
Applicant’s arguments and amendments with respect to drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments and amendments with respect to specification objections have been fully considered and are persuasive. The specification objections have been withdrawn.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The 112 rejections have been withdrawn.
Applicant’s arguments and amendments with respect to art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lloyd and Leadley; Hogan, Fink, and Leadley; and Lloyd, Zamba, and Leadley, and/or in the alternative, Lloyd, Zamba, Leadley, and Jonson.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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