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 .
Information Disclosure Statement
The information disclosure statement(s) filed on 08/26/2025 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Response to Amendment
This office action is in response to the amendment filed on 08/15/2025. As directed by the amendment, claims 1, 11, 13-14, 15-16, 18-20 have been amended, claims 2, 4, 6, 8 and 21-22 have been cancelled and claims 23-25 have been added. Furthermore, claim 23 will be withdrawn as it depends on withdrawn claim 15 due to an earlier restriction. As such, claims 1, 3, 5, 7, 9-14, 17-20 and 24-25 are being examined in the instant application.
Applicant has amended claim 11 to address a 112(b) rejection; the 112(b) rejection to claim 11 has been withdrawn as the language has been amended from “permit” to “provide space for.”
Response to Arguments
Applicant's arguments, see pages 6-10 of Remarks, filed 08/15/2025, pertaining to the
newly amended limitations have been noted and is now rejected by Schennum (US 8689786 B2) in view of Suman (US 20050072421 A1), Lehtonen (US 20090211576 A1) and Neugebauer (US 20150320945 A1).
Furthermore, applicant’s arguments on pages 9-10 recites “Persons having ordinary skill in the art understand from Neugebauer that the canister diameter and length are balanced to produce a desired interior volume between 7 and 30 ml” and states the maximum dimensions of the canisters lead to a maximum internal volume of less than 7ml. The examiner is not persuaded. The amended claim language does not disclose any language about the interior volume or maximum internal volume. Furthermore, Neugebauer recites “the interior volume of the canister may be 7 to 30 ml brim full.” Not to mention, Neugebauer also teaches the canister to have a diameter of 15 mm and a length of 20 mm (see [0030]) which is about 3.5 ml (using the formula given).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The term “compliant mechanism” of claim 14 invoke 112(f). The specification cites “…the term "mechanical linkage" includes compliant mechanisms which transmits an applied input force in one direct into an output force in a different direction. For example, the mechanical linkage may transmit an applied input force in a transverse direction into an output force in the longitudinal direction (see [0052]).” For examination purposes, as best understood, the term “compliant mechanism” refers a structure which transmits an applied input force in one direct into an output force in a different direction.
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3, 5, 7, 9-11, 13-14, 20 and 24-25 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Schennum (US 8689786 B2) in view of Suman (US 20050072421 A1), Lehtonen (US 20090211576 A1) and Neugebauer (US 20150320945 A1).
Regarding claim 1, Schennum teaches a pressurized metered dose inhaler (pMDI) (tubular body 1 and pressurized canister 2, see Figs. 1-5; Schennum teaches body 1 to enable a consumer to dispense a metered dose of aerosol of the pressurized contents that is delivered to the mouth of the consumer as seen in Figs. 4-5 and Col. 1, lines 19-20 and Col. 3, lines 4-11) configured to deliver metered doses of nicotine-containing liquid (“The contents of the canister 2 may comprise a nicotine-containing liquid with or without additional flavourants, so as to simulate a smoking article such as a cigarette although it will be appreciated that other compositions may be provided within the canister 2.” See Col. 5, lines 11-15) comprising:
a casing (cylindrical housing 9 and main body member 32, see Figs. 3 and 5) having a longitudinal axis (longitudinal axis X-X’, see Fig. 6a) and a transverse axis (there is a transverse axis perpendicular to the longitudinal axis, shown by the direction of arrow C as seen in Figs. 6a-6b), wherein the casing comprises a mouthpiece opening (mouth end 4, see Figs. 1 and 3) at one end along the longitudinal axis (mouth end 4 is at one end of the longitudinal axis as seen in Figs. 3 and 6a), wherein the casing is configured to house a pressurized medicament canister (pressurised canister 2, see Figs. 3-5) along the longitudinal axis (“The canister 2 is mounted with its longitudinal axis aligned with the longitudinal axis X-X' of the device…” see Col. 3, lines 27-28), wherein the medicament canister comprises doses of nicotine-containing liquid (“The contents of the canister 2 may comprise a nicotine-containing liquid with or without additional flavourants, so as to simulate a smoking article such as a cigarette although it will be appreciated that other compositions may be provided within the canister 2.” See Col. 5, lines 11-15) and a propellent (“…pressurised canister 2 that contains a liquid propellant such as but not limited to HFA 134a and a substance to be provided in an aerosol to the consumer.” See Col. 2, lines 58-61), and the medicament canister comprises a metered dose valve (valve cap 11, discharge tube 13 and valve 14, see Figs. 6a-6b) configured to release a metered dose of aerosolized nicotine through the mouthpiece opening along the longitudinal axis (Schennum teaches valve 14 to deliver an aerosolized metered dose of the pressurized contents of the canister through discharge tube 13 into the passageway 6 towards the mouth end 4 along the longitudinal axis as seen in X-X’ of the device as seen in Figs. 6a-6b and Col. 3, lines 25-38); wherein the metered dose valve comprises a stem (discharge tube 13, see Fig. 4and 12c) which is compressed relative to the medicament canister (Schennum teaches discharge tube 13 to slide inwardly relative to canister 2 as seen in Figs. 6a-6b and Col. 4, lines 22-36, and therefore, discharge tube 13 will be compressed relative to canister 2); and
a mechanical linkage (trigger 39, depressible surface portion 42 and camming surface portions 43, see Figs. 6a-6b) configured to translate an applied force to the mechanical linkage along the transverse axis into a force along the longitudinal axis configured to compress the stem to actuate the metered dose valve and release the metered dose of aerosolized pulmonary medicament in a longitudinal direction along the longitudinal axis throughout the pressurized metered dose inhaler (Schennum teaches trigger 39 with a manually depressible surface portion 42 in which when pressed transversely downwards in the direction of C, the camming surface portions 43 is moved longitudinally towards the canister 2 to drive discharge tube 13 inwardly against the canister and actuate valve 14 to release an aerosolized metered dose in a longitudinal direction along the longitudinal axis as seen in Figs. 6a-6b and Col. 4, lines 22-36 and line 63 to Col. 5, line 6).
But does not teach a miniaturized pressurized metered dose inhaler (pMDI) configured to deliver metered doses of rescue medication comprising a pulmonary medicament to persons experiencing chronic or acute respiratory disease;
wherein the medicament canister comprises between 20-50 doses of the pulmonary medicament, the medicament canister has an outer diameter in the range of 12 mm to 18 mm and a length in the range of 15 mm to 30 mm and wherein the metered dose valve has an outer diameter in the range of 12 mm to 18 mm.
However, Suman teaches a pressurized metered dose inhaler (pMDI) configured to deliver metered doses of rescue medication comprising a pulmonary medicament to persons experiencing chronic or acute respiratory disease (Suman teaches improvements made to metered dose inhaler drug delivery systems as seen in [0002] and further teaches using albuterol to treat acute and chronic asthma to elicit faster and longer-lasting bronchodilation as seen in [0007]. Not to mention, Suman teaches nicotine to be used as an inhalation aerosol as seen in [0004]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inhaler taught by Schennum to replace the nicotine flavor with albuterol as taught by Suman as a known liquid/medication to be used within inhalers and to aid in treating acute and chronic asthma (see [0007]).
However, Lehtonen teaches an inhaler with a dispenser system in which the medicament is to run out after 35 doses as seen in [0116] to prevent overdosing (see [0115]). Lehtonen further teaches a reservoir 208 in [0093].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inhaler taught by Schennum in view of Suman to have the medicament canister contain 35 doses of pulmonary medicament as taught by Lehtonen as a known number of doses to be used in the art for a dispenser system. Modified Schennum teaches wherein the medicament canister is sized to contain between 20 and 50 doses of the pulmonary medicament (pressurised canister 2 (taught by Schennum) is to contain 35 doses of medicament (taught by Lehtonen), and therefore, pressurised canister 2 would be sized to contain 35 doses of medicament).
However, Neugebauer teaches wherein the medicament canister has an outer diameter about 15 mm to 30 mm (Although Neugebauer does not explicitly teach an outer diameter, Neugebauer teaches a diameter of the canister to be 15 to 30 mm and a thickness of the sidewall to be 0.15 to 0.3 mm as seen in [0027]. As such, the outer diameter of the canister to be 15 mm to 30 mm ± 0.3 mm which is about 15 mm to 30 mm) and a length in the range of 20 mm to 75 mm (“In any case, the canister may have a diameter of 15 to 30 mm and/or a length of 20 to 75 mm, measured from the lowest point of the bottom wall along the longitudinal axis to the top cover.” See [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the medicament canister of the inhaler taught by modified Schennum to have a diameter of about 15 mm to 30 mm and a length of 20 mm to 75 mm as taught by Neugebauer as known diameters and lengths to be used in inhalers for canisters.
However, modified Schennum does not explicitly disclose the outer diameter to be in the range of 15 mm to 16 mm and length to be in the range of 20 mm to 24 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the outer diameter of the medicament canister of modified Schennum to be about 15 mm to 30 to be in the range of 15 mm and 16 mm and the length of the medicament canister of modified Schennum to be from 20 to 24 mm to be in the range of 20 mm and 30 mm as applicant appears to have placed no criticality on the claimed range (see [0039] indicating the outer diameter “may range from” within the claimed range and see [0040] indicating the length “may range from” within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Modified Schennum teaches the outer diameter of the pressurised canister 2 (taught by Schennum) to be in the range of 15 mm to 16 mm (taught by Neugebauer). It would have been obvious to one of ordinary skill in the art to have the metered dose valve have an outer diameter in the range of 15 mm to 16 mm to be of a similar dimension to the outer diameter of the medicament canister as Schennum shows valve 14 to be of similar outer diameter to the canister 2 in Fig. 8. Furthermore, the applicant appears to have placed no criticality on the claimed range (see [0041] indicating the valve outer diameter “may range from” within the claimed range).
Modified Schennum teaches the limitations above of claim 1 and therefore teaches a miniaturized pressurized metered dose inhaler (pMDI), especially as the size requirements/limitations and dose amount are taught.
Regarding claim 3, modified Schennum teaches the inhaler of claim 1, and further teaches wherein the medicament canister is sized to contain between 30 and 40 doses of the pulmonary medicament (pressurised canister 2 (taught by Schennum) is to contain 35 doses of medicament (taught by Lehtonen), and therefore, pressurised canister 2 would be sized to contain 35 doses of medicament).
Regarding claim 5, modified Schennum teaches the inhaler of claim 1, but does not teach wherein the medicament canister has an outer diameter in the range of 14 mm to 16 mm (Modified Schennum teaches the outer diameter of the pressurised canister 2 (taught by Schennum) to be in the range of 15 mm to 16 mm (taught by Neugebauer in claim 1 rejection above)).
Regarding claim 7, modified Schennum teaches the inhaler of claim 1, but does not teach wherein the metered dose valve has an outer diameter in the range of 14 mm to 16 mm (Modified Schennum teaches the outer diameter of valve 14 (taught by Schennum) to be in the range of 15 mm to 16 mm (see claim 1 rejection above)).
Regarding claim 9, modified Schennum teaches the inhaler of claim 1, but does not teach wherein the medicament canister has a length in the range of 19 mm to 24 mm (Modified Schennum teaches the length of the pressurised canister 2 (taught by Schennum) to be in the range of 20 mm to 24 mm (taught by Neugebauer in claim 1 rejection above)).
Regarding claim 10, modified Schennum teaches the inhaler of claim 1, and further teaches wherein the medicament canister comprises an internal dip tube (supply pipe 16, see Fig. 6a of Schennum) to syphon the pulmonary medicament when the medicament canister is oriented in a horizontal direction (Schennum teaches supply pipe 16 to feed the pressurized contents of canister 2 to the inlet of the valve 14 when the canister is oriented in a horizontal direction as seen in Fig. 6a and Col. 3, lines 35-38. Suman teaches the canister to be filled with albuterol as seen in [0007]).
Regarding claim 11, modified Schennum teaches the inhaler of claim 1, and further teaches further comprising a chamber (nozzle member 44, see Figs. 6a-6b and 12b-12c of Schennum) connected to the metered dose valve to provide space for mixing and expansion of the pulmonary medicament as it is released from the metered dose valve (nozzle member 44 is connected to discharge tube 13 and is to receive a metered dose of the pressurised contents from the discharge tube 13and provide a space for mixing and expansion of the pressurized contents as seen in Fig. 12c and Col. 4, lines 37-48 of Schennum. Furthermore, Suman teaches the canister 2 to be filled with albuterol as seen in [0007]), wherein the chamber receives pulmonary medicament released from the metered dose valve in the longitudinal direction and the aerosolized pulmonary medicament exits the chamber in the longitudinal direction (nozzle member 44 of Schenumm receives albuterol (taught by Suman) released from discharge tube 13 and valve 14 in the longitudinal direction as seen in Fig. 12c of Schenumm. Furthermore, Schenumm teaches a nozzle 48 at the end of nozzle member 44 in which the aerosol contents will be discharged from nozzle member 44 in the longitudinal direction as seen in Fig. 12c and Col. 4, lines 37-48 of Schenumm).
Regarding claim 13, modified Schennum teaches the inhaler of claim 1, and Schennum further teaches wherein the mechanical linkage moves the medicament canister relative to the stem to compress the stem (Schennum teaches trigger 39 with a manually depressible surface portion 42 in which when pressed transversely downwards in the direction of C, the camming surface portions 43 is moved longitudinally towards the canister 2 to drive discharge tube 13 inwardly against the canister 2 and actuate valve 14 to release an aerosolized metered dose in a longitudinal direction along the longitudinal axis as seen in Figs. 6a-6b and Col. 4, lines 22-36 and line 63 to Col. 5, line 6. Therefore, pressurised canister 2 is moved when trigger 39 is depressed when discharge tube 13 is moved inwardly against the canister 2 to be compressed).
Regarding claim 14, modified Schennum teaches the inhaler of claim 1, and Schennum further teaches wherein the mechanical linkage comprises a compliant mechanism ([0052] recites “the term "mechanical linkage" includes compliant mechanisms which transmits an applied input force in one direct into an output force in a different direction. For example, the mechanical linkage may transmit an applied input force in a transverse direction into an output force in the longitudinal direction.” Schennum teaches trigger 39 with a manually depressible surface portion 42 in which when pressed transversely downwards in the direction of C, the camming surface portions 43 is moved longitudinally towards the canister 2 to drive discharge tube 13 inwardly against the canister and actuate valve 14 to release an aerosolized metered dose in a longitudinal direction along the longitudinal axis as seen in Figs. 6a-6b and Col. 4, lines 22-36 and line 63 to Col. 5, line 6).
Regarding claim 20, modified Schennum teaches the inhaler of claim 1, and Turner further teaches wherein the main direction of the pulmonary medicament fluid flow exiting the casing is constant in time (Schennum teaches aerosolized contents of the canister 2 to be discharged through nozzle 48, wherein the Suman teaches the canister 2 to be filled with albuterol as seen in [0007]. The aerosolized albuterol is to be discharged into the interior passageway 6 before exiting through mouth end 4 into the consumer’s mouth in the longitudinal direction as seen in Figs. 6a-6b and Col. 4, line 63 to Col. 5, line 10 of Schenumm. Furthermore, the main direction the albuterol is flowing from when mouth end 4 will be constant over time).
Regarding claim 24, modified Schennum teaches the inhaler of claim 1, and further teaches wherein the medicament canister has a length in the range of 15 mm to 27 mm (Modified Schennum teaches the length of the pressurised canister 2 (taught by Schenumm) to be in the range of 20 mm to 24 mm (taught by Neugebauer in claim 1 rejection above)).
Regarding claim 25, modified Schennum teaches the inhaler of claim 1, and further teaches wherein the medicament canister has an outer diameter in the range of 14 mm to 16 mm and a length in the range of 19 mm to 24 mm (Modified Schennum teaches the outer diameter of the pressurised canister 2 (taught by Schenumm) to be in the range of 15 mm to 16 mm and the length of the pressurised canister 2 to be in the range of 20 mm to 24 mm (taught by Neugebauer in claim 1 rejection above)).
Claim(s) 12 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Schennum (US 8689786 B2) in view of Suman (US 20050072421 A1), Lehtonen (US 20090211576 A1) and Neugebauer (US 20150320945 A1), as applied to claim 1 above, and further in view of Truza (US 20070012316 A1).
Regarding claim 12, modified Schennum teaches the inhaler of claim 1, but does not teach wherein the casing comprises a key ring attachment structure.
However, Truza teaches wherein the casing (housing 12, see Fig. 1) comprises a key ring attachment structure (attachment member 26, see Fig. 1; “The inhaler 10 further includes an attachment member 26 operatively attached to the housing 12 to facilitate removable attachment of the inhaler 10 to a person. As shown in FIG. 1, the attachment member 26 is a key ring. However, those having ordinary skill in the art will appreciate that the attachment member 26 may be any other structure adapted to facilitate such attachment.” See [0019]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inhaler taught by modified Schennum to include a key ring attachment structure as taught by Truza to allow removable attachment of the inhaler to a user (see [0019]).
Claim(s) 17-19 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Schennum (US 8689786 B2) in view of Suman (US 20050072421 A1), Lehtonen (US 20090211576 A1) and Neugebauer (US 20150320945 A1), as applied to claim 1 above, and further in view of Kakade (US 20080203193 A1).
Regarding claim 17, modified Schennum teaches the inhaler of claim 1, but does not teach wherein the casing comprises one or more air inlet holes configured to allow air to enter the casing.
However, Kakade teaches wherein the casing (mouthpiece insert 50 and mouthpiece 60, see Figs. 10-11) comprises one or more air inlet holes configured to allow air to enter the casing (mouthpiece insert 50 comprises of air inlets 56 which is symmetrical to avoid deviating the aerosol spray to one side of the insert 50 which can decrease the efficiency of spray delivery and can cause significant deposition on the walls of the insert 50 as seen in Fig. 11 and [0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inhaler taught by modified Schennum to include air inlets as taught by Kakade to control the aerosol velocity using the air inlet size/cross-sectional area and increase efficacy of spray delivery (see [0030]-[0031]).
Regarding claim 18, modified Schennum teaches the inhaler of claim 1, and further teaches wherein the aerosolized pulmonary medicament exits the casing in a fluid flow along the longitudinal axis (Schennum teaches aerosolized contents of the canister 2 to be discharged through nozzle 48, wherein the Suman teaches the canister 2 to be filled with albuterol as seen in [0007]. The aerosolized albuterol is to be discharged into the interior passageway 6 before exiting through mouth end 4 into the consumer’s mouth as seen in Figs. 6a-6b and Col. 4, line 63 to Col. 5, line 10 of Schenumm)
But does not teach wherein the aerosolized pulmonary medicament exits the casing in a fluid flow which is symmetric in a vertical plane along the longitudinal axis.
However, Kakade teaches wherein the aerosolized medicament exits the casing (mouthpiece insert 50 and mouthpiece 60, see Figs. 10-11) in a fluid flow which is symmetric in a vertical plane along the longitudinal axis ([0062] of applicant’s specification discusses air inlets 88 and 90 that promote an efficient flow of air through casing 62 so that the fluid flow is symmetric. Figs. 10 and 11 illustrate the air inlets 88 and 90. Kakade teaches an atomization system which reduces which reduces aerosol plume velocity and increases efficiency of spray delivery as seen in [0002], wherein the aerosolized spray is a propellent/medicament mixture as seen in [0037]). Kakade further teaches mouthpiece insert 50 to comprise of air inlets 56 which is symmetrical to avoid deviating the aerosol spray to one side of the insert 50 which can decrease the efficiency of spray delivery and can cause significant deposition on the walls of the insert 50 as seen in Fig. 11 and [0031]. Therefore, Kakade teaches aerosolized medicament to exit mouthpiece insert 50 in a fluid flow which is symmetric in a vertical plane along the longitudinal axis).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inhaler taught by modified Schennum to include air inlets as taught by Kakade to control the aerosol velocity using the air inlet size/cross-sectional area and increase efficacy of spray delivery (see [0030]-[0031]).
Regarding claim 19, modified Schennum teaches the inhaler of claim 1, but does not teach wherein the aerosolized pulmonary medicament exits the casing in a fluid flow which is symmetric in a vertical plane.
However, Kakade teaches wherein the aerosolized pulmonary medicament exits the casing (mouthpiece insert 50 and mouthpiece 60, see Figs. 10-11) in a fluid flow which is symmetric in a vertical plane ([0062] of applicant’s specification discusses air inlets 88 and 90 that promote an efficient flow of air through casing 62 so that the fluid flow is symmetric. Figs. 10 and 11 illustrate the air inlets 88 and 90. Kakade teaches an atomization system which reduces which reduces aerosol plume velocity and increases efficiency of spray delivery as seen in [0002], wherein the aerosolized spray is a propellent/medicament mixture as seen in [0037]). Kakade further teaches mouthpiece insert 50 to comprise of air inlets 56 which is symmetrical to avoid deviating the aerosol spray to one side of the insert 50 which can decrease the efficiency of spray delivery and can cause significant deposition on the walls of the insert 50 as seen in Fig. 11 and [0031]. Therefore, Kakade teaches aerosolized medicament to exit mouthpiece insert 50 in a fluid flow which is symmetric in a vertical plane).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inhaler taught by modified Schennum to include air inlets as taught by Kakade to control the aerosol velocity using the air inlet size/cross-sectional area and increase efficacy of spray delivery (see [0030]-[0031]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tina Zhang whose telephone number is (571)272-6956. The examiner can normally be reached Monday - Friday 9:00AM-5:00PM.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785