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) because they fail to show the pressure sensor as described in the specification. Although reference numeral 12 is used for the pressure sensor, reference numeral 12 in Fig. 3 merely points to a nozzle at the distal end of the flow path, which does not resemble any type of sensor. It is noted that any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 8, 10-12, 14-16, and 19-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites a “detector mounted upstream of the aerosol generator along a direction extending parallel to the flow path and normal to an outlet opening of the mouthpiece…” Although the detector (12? See drawing objection above) does appear to be parallel to the flow path, it is unclear how the detector can also be “normal” or perpendicular to the outlet opening, assuming the outlet opening to be represented by at least reference numeral 3. Since the detector appears to be parallel to the outlet opening and not normal to the outlet opening, the original disclosure fails to support a detector that is normal to the outlet opening. It is noted that that the word “normal” does not appear to be used in the original specification with regard to the detector. For examination purposes, a detector extending parallel to an outlet opening will be assumed.
The remaining claims are rejected by virtue of being dependent on a rejected base claim.
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 31 and 32 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 31 recites “the plurality of protrusions including a protrusion extending… between a pair of protrusions…” It is unclear of the claimed “pair” of protrusions are part of or a subset of the “plurality” of protrusions or if they are a different set of protrusions altogether.
Claim 32 recites the limitation “the pair of protrusions” in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 1-5, 8, 10-12, 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 No. 5,404,871 to Goodman et al. (“Goodman”) and 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), a detector (37) mounted upstream of the aerosol generator (since air enters through 41, sensor 37 is upstream from 42) along a direction extending parallel to the flow path (35/36 are parallel to the flow path at 29) and parallel to an outlet opening of the mouthpiece (35/36 are parallel to the outlet 30), wherein the controller is configured to track cause the device to deliver the aerosol generated by the aerosol generator via the mouthpiece (column 13, lines 47-55) but does not explicitly mention tracking a breathing pattern and does not teach the protrusions.
Goodman teaches a controller being configured to track a breathing pattern using a detector (column 34, lines 48-60). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated breathing tracking in the controller of Lloyd as taught by Goodman, as the trend data can be used to study the original drug therapy to alter the therapy as necessary (column 34, lines 57-60). Additionally, it is noted that Goodman is an example of a sensor that was incorporated by Lloyd (Lloyd column 14, lines 3-6).
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 (Fig. 12B) to enhance turbulent flow ([0082]) of fluid 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 increase or decrease the degree of airflow to suit the particular need or application ([0082]).
Regarding claim 2, Lloyd, Goodman, 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, Goodman, 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 4, Lloyd, Goodman, and Leadley teach the device as claim in claim 2 as shown above, but do not mention the majority fraction.
Lloyd discloses that particle size can be adjusted by adjusting the amount of energy added (column 4, lines 51-53). The range of the size of the majority faction of the droplets and the associated majority fraction percentage range is a result effective variable in that changing the amount of energy added is necessary to provide a certain droplet size or percentage of droplets having that size to suit the particular needs of the patient and/or fulfill the treatment plan of the practitioner. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Lloyd, Goodm, and Leadley to provide droplets of a particular size and majority fraction within the claimed range, as it involves only adjusting the amount of energy which would require adjustment based on the aforementioned factors. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aerosol generator of Lloyd to provide droplets for which a majority fraction has a size greater than 10 µm and wherein the majority fraction is at least 75% as a matter of routing optimization since it has been held that “[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 5, Lloyd, Goodman, 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, Goodman, 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 start of breath inhalation (column 16, lines 1-10).
Regarding claim 10, Lloyd, Goodman, and Leadley teach the device as claimed in claim 1 as shown above, Lloyd further teaching the detector being configured to detect inhalation or exhalation (column 19, lines 53-57).
Regarding claim 11, Lloyd, Goodman, and Leadley teach the device as claimed in claim 1 as shown above, Lloyd further teaching the detector comprises one or more of temperature, pressure, flow and auditory sensors (flow sensor 31).
Regarding claim 12, Lloyd, Goodman, and Leadley teach the device as claimed in claim 1 as shown above, Lloyd further teaching the detector comprises a pressure sensor (37).
Regarding claim 32, Lloyd, Goodman, and Leadley teach the nebulizer device as claimed in claim 1 as shown above, Leadley further teaching wherein each protrusion of the pair of protrusions extending within the plan perpendicular to the flow path 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).
Claims 15, 21-24, 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Lloyd in view Goodman and 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, Goodman, and Leadley teach the device as claimed in claim 1 as shown above, Lloyd further teaching a controller configured to control a method of operation including the steps of providing the liquid containing an active agent (column 11, lines 53-57), aerosolising the liquid to generate the 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 via the mouthpiece (the aerosol passes through the mouthpiece), but does not teach starting and stopping relative to inhalation.
Raabe teaches starting aerosol generation after an 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 a subsequent start of breath inhalation (see claim 3 of Raabe, aerosol generation is synchronized with exhalation, therefore it ends before a subsequent 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 an end of breath inhalation and stopping aerosol generation before a subsequent 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, Goodman, 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 the 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 via the mouthpiece (the aerosol passes through the mouthpiece), but does not teach starting aerosol generation after an end of breath inhalation and stopping aerosol generation before a subsequent start of breath inhalation.
Raabe teaches starting aerosol generation after an 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 a subsequent start of breath inhalation (see claim 3 of Raabe, aerosol generation is synchronized with inhalation, therefore it ends before a subsequent 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 an end of breath inhalation and stopping aerosol generation before a subsequent 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, Goodman, 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, Goodman, 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, Goodman, Leadley, and Raabe teach the method as claimed in claim 21 as shown above, Goodman previously teaching monitoring the breathing pattern and Raabe further teaching controlling the aerosol generation such that aerosol is generated outside of inhaling (in the embodiment where the signals are reversed, column 3, lines 35-45, the aerosol is generated during exhalation, i.e., outside of inhalation, also see claim 3 of Raabe).
Regarding claim 26, Lloyd, Goodman, 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 detection of start of exhalation (see claim 3 of Raabe).
Regarding claim 27, Lloyd, Goodman, 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 detection of end of exhalation (see claim 3 of Raabe).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Lloyd in view of Goodman 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, Goodman, and Leadley teach a device as claimed in claim 1 as shown above, Lloyd further teaching the device comprises, in order from proximal to distal towards a patient’s mouth in use (Fig. 1): the aerosol generator (42) and a volume defined by the housing (29), and Leadley previously teaching the plurality of protrusions, but do not show the position of the sensor and the outlet mesh.
Klimowicz teaches a detector (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, Goodman, 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, Goodman, Leadley, and Raabe teach the method as claimed in claim 21 as shown above, Goodman previously teaching monitoring the breathing pattern, but do not teach stopping generation of aerosol in response to an irregular inhalation.
Knoch teaches stopping generation of aerosol in response to an 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, Goodman, Leadley, and Raabe to stop in response to 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, Goodman, 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, Goodman, 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, Goodman, 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, a plurality of protrusions, and the claimed details of the controller, although the bottom of housing 29 could be considered a mouthpiece given the broadest reasonable interpretation.
Fink teaches a mouthpiece (Fig. 10A, connected to 912) defined by a housing (housing of 902) including a flow path (arrows below area designated by 912), a detector (connected to 916) mounted upstream (916 is upstream because of inlet 914) of the aerosol generator along a direction parallel to the flow path (912 and 916 are parallel) and parallel to an outlet opening of the mouthpiece (912 and 916 are parallel), wherein the controller is configured to track a breathing pattern using the detector and to cause the device to deliver the aerosol generated by the aerosol according to the breather pattern ([0122]). 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. Furthermore, 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 controller of Hogan and Fink to track breathing patterns as taught by Fink as such information is used to make adjustments to the amount of medicament or gas added ([0122]) to optimize treatment for the 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 to 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 increase or decrease the degree of airflow to suit the particular need or application ([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 30 is rejected under 35 U.S.C. 103 as being unpatentable over Lloyd in view of U.S. Patent No. 5,394,866 to Ritson et al. (“Ritson”) and Leadley.
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), a detector (37), 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 protrusions and does not explicitly teach detecting exhalation and a response thereof.
Ritson teaches a controller configured to cause the aerosol generator to commence aerosolization in response to exhalation detected by the detector and to cause the device to deliver the aerosol generator via the mouthpiece (column 27, lines 26-35). 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 controller to be responsive to exhalation as taught by Ritson to yield the predictable result of providing information to aid in drug dispensation. Additionally, it is noted that Ritson is an example of a sensor that was incorporated by Lloyd (Lloyd column 14, lines 6-8).
Leadley teaches a plurality of protrusions disposed within a flow path, each protrusion of the plurality of protrusions extending into the flow path to enhance turbulent flow of air within the flow path ([0082]). 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 increase or decrease the degree of airflow to suit the particular need or application ([0082]).
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 pair of protrusions (any pair of 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]). Once combined, at least “one” of the plurality of protrusions of Zamba running parallel to the flow path would be positioned between one of the pairs of protrusions of Leadley running perpendicular to the flow path.
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 art rejections of claims 1 and 30 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, Goodman, and Leadley; and Hogan, Fink, and Leadley, respectively.
Applicant's arguments and amendments with respect to art rejection of claim 31 have been fully considered but they are not persuasive. Applicant argues that Leadley does not teach a protrusion extending parallel to the flow path and between a pair of protrusions extending with the plane perpendicular to the flow path. Examiner submits that Leadley is not being relied upon to teach the protrusion extending parallel to the flow path, since such a limitation is shown by Zamba. Examiner also submits that Leadley does teach a pair of protrusions extending perpendicularly as shown above. The rejection stands.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
