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 .
Response to Amendments
The Amendment filed 7/2/2026 has been entered. Claims 1-20 were amended, and claims 21-22 were new. Thus, claims 1-22 are pending in the application.
Claim Objections
Claims 2, 14, and 21 are objected to because of the following informalities:
Claim 2 recites “the pressure in the reduced-pressure zone of each of the further cyclone chambers” in lines 11-12 and is suggested to read --a pressure in the reduced-pressure zone of each of the further cyclone chambers-- in order to ensure proper antecedent basis.
Claim 2 recites “the pressure in the reduced-pressure zone of the next-downstream cyclone chamber” in lines 12-13 and is suggested to read --a pressure in the reduced-pressure zone of the next-downstream cyclone chamber-- in order to ensure proper antecedent basis.
Claim 14 recites “cyclonic-apparatus inlet” in line 2 and is suggested to read --cyclonic apparatus inlet-- (i.e. delete the hyphen) in order to more clearly reference how the limitation was originally claimed.
Claim 21 recites “cyclonic-apparatus inlet” in line 2 and is suggested to read --cyclonic apparatus inlet-- (i.e. delete the hyphen) in order to more clearly reference how the limitation was originally claimed.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 5, 7, 9-10, 13-16, 18, and 21-22 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.
Regarding claim 2, the limitation “the next-downstream cyclone chamber” in line 5 is confusing, as it is unclear whether this limitation is meant to be a part of or separate from “a first cyclone chamber” in claim 1 and/or “one or more further cyclone chambers arranged in series” in line 2. For the purposes of examination, it will be interpreted as being one of those limitations.
Regarding claim 5, the limitation “a series of cyclone chambers” in line 2 is confusing, as it is unclear whether this limitation is meant to include or be separate from “a first cyclone chamber” in claim 1 and/or “one or more further cyclone chambers arranged in series” in claim 2. For the purposes of examination, it will be interpreted as including those claim 1-2 limitations. Moreover, the limitations “a reduced-pressure inlet thereof” in lines 2-3 and “a reduced pressure applied” in line 3 are confusing, as it is unclear whether these limitations are meant to be the same as, include, or be separate from “a first reduced-pressure inlet” in claim 1/“a further reduced-pressure inlet” in claim 2 and “the pressure in the reduced-pressure zone” in claim 2, respectively. For the purposes of examination, they will be interpreted as being the same respective limitations.
Regarding claim 10, the limitation “a next-downstream conduit” in line 3 is confusing, as it is unclear whether this limitation is meant to include or be separate from “the conduits” in line 1. For the purposes of examination, it will be interpreted as being one of “the conduits”.
Claim 13 recites the limitation “the next-downstream cyclone chamber of the two or more cyclone chambers” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation “the drug-delivery device” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the series" in line 2. There is insufficient antecedent basis for this limitation in the claim. Moreover, the limitations “a reduced-pressure inlet thereof” in line 3 and “a reduced pressure applied” in line 3 are confusing, as it is unclear whether these limitations are meant to be the same as, include, or be separate from “a first reduced-pressure inlet” in claim 1/“a second reduced-pressure inlet” in claim 3 and “a lower pressure” in claim 3, respectively. For the purposes of examination, they will be interpreted as being the same respective limitations.
Any remaining claims are rejected based on their dependency on a rejected base claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-7, 11-14, 18-19, and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Braithwaite (US 2004/0251318 A1), hereinafter Braithwaite ‘318.
Regarding claim 1, Braithwaite ‘318 discloses a cyclonic apparatus having a cyclonic apparatus inlet and a cyclonic apparatus outlet (amplifying system having an opening for the gas inlet aperture 214 and an aperture 215; alternatively, the cyclonic apparatus inlet can be cavity 222) (Figs. 4-6; abstract; paras. [0107-0109]) and comprising:
a first cyclone chamber having a first cyclone inlet to the first cyclone chamber, a first reduced-pressure inlet to the first cyclone chamber, the first reduced-pressure inlet forming or in fluid connection with the cyclonic-apparatus inlet so that fluid from the cyclonic apparatus inlet enters the cyclone chamber through the first reduced-pressure inlet, and a first outlet from the first cyclone chamber, the first outlet forming the cyclonic apparatus outlet (a jet ring 206 has a side passage to an inlet of the hollow frustoconical portion 217 to an outlet of the hollow frustoconical portion 217 at aperture 215, all of which are in fluid communication with gas inlet aperture 214/cavity 222; jet ring 206 closest to the aperture 215 as the first cyclone chamber) (Figs. 4-6; paras. [0107-0109]; see annotated Images 1-2 below);
in which the first cyclone chamber has an axis (a longitudinal axis though all the jet rings 206 from gas inlet aperture 214 to aperture 215) (Figs. 4-6);
the first cyclone chamber being operable to establish a cyclonic flow of fluid between the first cyclone inlet and the first outlet in response to fluid being drawn from the first outlet by the inspiratory energy of a patient, so as to create a first reduced-pressure zone of fluid at the first reduced-pressure inlet, the cyclonic flow of fluid being established around the axis, in which the first reduced-pressure inlet is at an axial position downstream of the first cyclone inlet in the first cyclone chamber (chambers in the jet rings 206 are for non-laminar flow, thus forming a cyclonic flow; there would be a cyclonic flow between the first cyclone inlet and the first outlet around the central axis in response to fluid being drawn from the aperture 215, which coincides with inspiration of a patient; as fluid flows through the chamber, there would be a first-reduced pressure zone of fluid, or vacuum, at the first reduced-pressure inlet; first reduced-pressure inlet is axially downstream of the first cyclone inlet) (Figs. 4-6; abstract; para. [0022]; para. [0039]; paras. [0107-0109]; see annotated Images 1-2 below).
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Image 1: Annotation of Braithwaite ‘318 Fig. 6 to illustrate the first cyclone inlet, the first reduced-pressure inlet, and the first outlet.
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Image 2: Annotation of Braithwaite ‘318 Fig. 6 to illustrate an alternative for the first cyclone inlet, the first reduced-pressure inlet, and the first outlet.
Regarding claim 2, as best understood, Braithwaite ‘318 discloses comprising: one or more further cyclone chambers arranged in series upstream of the first cyclone chamber, each further cyclone chamber having a further cyclone inlet, a further reduced-pressure inlet, and a further outlet, wherein the further outlet of each further cyclone chamber is coupled to the reduced-pressure inlet of the next-downstream cyclone chamber (jet rings 206 above and upstream of the bottom jet ring 206, and which have the same respective structures as illustrated in the annotated Images 1-2 above; a respective outlet of a jet ring 206 would be fluidly coupled to a subsequent downstream chamber in the next jet ring 206 with a reduced-pressure inlet) (Figs. 4-6; para. [0107]; para. [0109]; see annotated Images 1-2 above); each further cyclone chamber being operable to establish a cyclonic flow of fluid between the further cyclone inlet and the further outlet of that further cyclone chamber and to create a reduced-pressure zone of fluid at the further reduced-pressure inlet of that further cyclone chamber in response to fluid being drawn from the further outlet by the reduced-pressure zone of fluid in the next-downstream cyclone chamber (chambers in the jet rings 206 are for non-laminar flow, thus forming a cyclonic flow; there would be a cyclonic flow between each cyclone inlet and each outlet of the jet rings 206 in response to fluid being drawn from the aperture 215 and the downstream outlets of downstream jet rings 206; as fluid flows through the chambers, there would be reduced pressure zones of fluid, or vacuums, at the reduced-pressure inlets) (Figs. 4-6; abstract; para. [0022]; para. [0039]; para. [0107]; para. [0109]; see annotated Images 1-2 above); in which the pressure in the reduced-pressure zone of each of the further cyclone chambers is lower than the pressure in the reduced-pressure zone of the next-downstream cyclone chamber (as Braithwaite ‘318 discloses the structure as claimed, it would function such that the pressure in the reduced-pressure zone of each cyclone chamber is lower than the pressure in the reduced-pressure zone of the next-downstream cyclone chamber as functionally claimed; also, the Braithwaite ‘318 system is for amplifying fluid, and so would amplify the fluid pressure as the fluid travels through the device) (Figs. 4-6; abstract; claim 1); and in which the reduced-pressure inlet of the further cyclone chamber at an upstream end of the series forms the cyclonic apparatus inlet (the reduced-pressure inlet of the top jet ring 206 of the series of jet rings 206 forming cyclones would form the opening at gas inlet aperture 214) (Figs. 4-6; para. [0107]; para. [0109]; see annotated Images 1-2 above).
Regarding claim 3, Braithwaite ‘318 discloses further comprising: a second cyclone chamber having a second outlet coupled to the first reduced-pressure inlet, a second cyclone inlet and a second reduced-pressure inlet (a second jet ring 206 above and upstream of the bottom jet ring 206, and which have the same respective structures as illustrated in the annotated Images 1-2 above; the outlet of the top jet ring 206 would be fluidly coupled to the downstream bottom jet ring 206 with its reduced-pressure inlet) (Figs. 4-6; para. [0107]; para. [0109]; see annotated Images 1-2 above), the second chamber being operable to create a second reduced-pressure zone of fluid in response to fluid being drawn from the second outlet by the first reduced-pressure zone (chambers in the jet rings 206 are for non-laminar flow, thus forming a cyclonic flow; as fluid flows through the chamber, there would be a second-reduced pressure zone of fluid, or vacuum, at the second reduced-pressure inlet in response to the fluid being drawn through the second outlet by the downstream first-reduced pressure zone) (Figs. 4-6; abstract; para. [0022]; para. [0039]; para. [0107]; para. [0109]; see annotated Images 1-2 above), wherein the fluid in the second reduced-pressure zone is at a lower pressure than the fluid in the first reduced-pressure zone (as Braithwaite ‘318 discloses the structure as claimed, it would function such that the fluid in the second reduced-pressure zone is at a lower pressure than the fluid in the first reduced-pressure zone as functionally claimed; also, the Braithwaite ‘318 system is for amplifying fluid, and so would amplify the fluid pressure as the fluid travels through the device) (Figs. 4-6; abstract; claim 1).
Regarding claim 4, Braithwaite ‘318 discloses further comprising: a third cyclone chamber having a third outlet coupled to the second reduced-pressure inlet, a third cyclone inlet and a third reduced-pressure inlet (a third jet ring 206 above and upstream of the second jet ring 206, and which have the same respective structures as illustrated in the annotated Images 1-2 above; the outlet of the third jet ring 206 would be fluidly coupled to the downstream second jet ring 206 with its reduced-pressure inlet) (Figs. 4-6; para. [0107]; para. [0109]; see annotated Images 1-2 above), the third chamber being operable to create a third reduced-pressure zone of fluid in response to fluid being drawn from the third outlet by the second reduced-pressure zone (chambers in the jet rings 206 are for non-laminar flow, thus forming a cyclonic flow; as fluid flows through the chamber, there would be a third-reduced pressure zone of fluid, or vacuum, at the third reduced-pressure inlet in response to the fluid being drawn through the third outlet by the downstream second-reduced pressure zone) (Figs. 4-6; abstract; para. [0022]; para. [0039]; para. [0107]; para. [0109]; see annotated Images 1-2 above), wherein the fluid in the third reduced-pressure zone is at a lower pressure than the fluid in the second reduced-pressure zone (as Braithwaite ‘318 discloses the structure as claimed, it would function such that the fluid in the third reduced-pressure zone is at a lower pressure than the fluid in the second reduced-pressure zone as functionally claimed; also, the Braithwaite ‘318 system is for amplifying fluid, and so would amplify the fluid pressure as the fluid travels through the device) (Figs. 4-6; abstract; claim 1).
Regarding claim 5, as best understood, Braithwaite ‘318 discloses in which each of the cyclone chambers in a series of cyclone chambers progressively amplifies, at a reduced-pressure inlet thereof, a reduced pressure applied, in use, to the cyclonic apparatus outlet (as Braithwaite ‘318 discloses the structure as claimed, it would function such that each cyclone chamber in the series progressively amplifies, at a reduced-pressure inlet, a reduced pressure applied, in use, to the cyclonic-apparatus outlet as functionally claimed; also, the Braithwaite ‘318 system is for amplifying fluid, and so would amplify the fluid pressure as the fluid travels through the device) (Figs. 4-6; abstract; claim 1).
Regarding claim 6, Braithwaite ‘318 discloses in which the first cyclone chamber is unidirectional (the jet rings 206 direct flow in the same direction towards the aperture 215) (Figs. 4-6; para. [0107]; see annotated Images 1-2 above).
Regarding claim 7, Braithwaite ‘318 discloses in which the first cyclone chamber and the one or more further cyclone chambers are arranged coaxially with each other (the jet rings 206 are coaxial with each other) (Figs. 4-6).
Regarding claim 11, Braithwaite ‘318 discloses in which the first cyclone inlet of the first cyclone chamber is spaced along an axis of the cyclone formed, in use, in the first cyclone chamber (the cyclone inlet of each jet ring 206 is spaced along an axis of the resulting non-laminar flow or cyclone in the chamber, the axis being in the vertical direction from gas inlet aperture 214 to aperture 215) (Figs. 4-6; abstract; para. [0107]; see annotated Images 1-2 above).
Regarding claim 12, Braithwaite ‘318 discloses in which the first cyclone inlet of first cyclone chamber is tangential to the cyclone formed, in use, in the first cyclone chamber (the cyclone inlet of each jet ring 206 would be tangential to the resulting non-laminar flow or cyclone in the chamber, particularly at the bend before the reduced-pressure inlet) (Figs. 4-6; abstract; para. [0107]; see annotated Image 2 above).
Regarding claim 13, as best understood, Braithwaite ‘318 discloses further comprising two or more cyclone chambers arranged in series with the first cyclone chamber, in which each of the two or more cyclone chambers has a higher airflow resistance than the next-downstream cyclone chamber of the two or more cyclone chambers (annular recess 214 and a downstream jet ring 206 are in series; as the diameter of the annular recess 214 is smaller than the diameter of the passages in a jet ring 206, the annular recess 214 would have a higher airflow resistance; alternatively, each of the jet rings 206 are in series, and a cyclone inlet and/or reduced-pressure inlet of a jet ring 206 has a smaller diameter than its outlet, thereby providing a higher airflow resistance cyclone inlet and/or reduced-pressure inlet than at the outlet; thus, an upstream jet ring 206 would provide a higher airflow resistance at the cyclone inlet and/or reduced-pressure inlet portion than a downstream jet inlet 206 would have at its outlet portion) (Figs. 4-6; para. [0107]; see annotated Images 1-2 above).
Regarding claim 14, as best understood, Braithwaite ‘318 discloses the drug-delivery device in which a source of a medicament is coupled to the cyclonic-apparatus inlet of a cyclonic apparatus as defined in claim 1 (amplifying system, which is a power delivery device 211 with a gas inlet aperture 214, is fluidly coupled to a dry powder inhaler, which would have a source of dry powder) (Figs. 4-6; para. [0037]; para. [0043]; para. [0107]).
Regarding claim 18, as best understood, Braithwaite ‘318 discloses in which each of the cyclone chambers in the series of the first cyclone chamber and the second cyclone chamber progressively amplifies, at a reduced-pressure inlet thereof, a reduced pressure applied, in use, to the cyclonic apparatus outlet (as Braithwaite ‘318 discloses the structure as claimed, it would function such that each cyclone chamber in the series progressively amplifies, at a reduced-pressure inlet, a reduced pressure applied, in use, to the cyclonic apparatus outlet as functionally claimed; also, the Braithwaite ‘318 system is for amplifying fluid, and so would amplify the fluid pressure as the fluid travels through the device) (Figs. 4-6; abstract; claim 1).
Regarding claim 19, Braithwaite ‘318 discloses in which the first cyclone chamber and the second cyclone chamber are arranged coaxially with each other (the jet rings 206 are coaxial with each other, and so the resulting non-laminar flows or cyclones they produced would be similarly coaxial) (Figs. 4-6).
Regarding claim 21, Braithwaite ‘318 discloses the first reduced-pressure inlet being in fluid connection with the cyclonic-apparatus inlet so that in use, medicament from the source of medicament is drawn into the first cyclone chamber through the first reduced-pressure inlet at an axial position downstream of the first cyclone inlet in the first cyclone chamber (the reduced-pressure inlet of each jet ring 206 is in fluid connection with the gas inlet aperture 214 and cavity 222; the dry powder fed into cavity 222 from a dry powder inhaler would be drawn into the space inside each jet ring 206 through the respective annotated reduced-pressure inlets; as annotated, each respective reduced-pressure inlet is at an axial position downstream of their respective cyclone inlet in a jet ring 206, including the jet ring 206 closest to the aperture 215) (Figs. 4-6; para. [0037]; para. [0043]; paras. [0107-109]; see annotated Images 1-2 above).
Regarding claim 22, Braithwaite ‘318 discloses in which the medicament is a dry powder formulation containing an active pharmaceutical ingredient, and in which the drug-delivery device is a dry powder inhaler (DPI) (dry powder has systemically active materials such as hormones, insulin, anticoagulants, etc., and the amplifying system is fluidly coupled to a dry powder inhaler) (Figs. 4-6; para. [0037]; para. [0043]; para. [0053]; para. [0107]).
Claim Rejections - 35 USC § 103
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 8-10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Braithwaite ‘318 as applied to claims 1-3 above, and further in view of Dunne (US 2011/0041844 A1).
Regarding claim 8, Braithwaite ‘318 discloses the invention as previously claimed, including in which the first cyclone chamber comprises a conduit having an inlet end and an outlet end (see annotated Image 3 below), but does not disclose being tapered from a larger diameter at the inlet end to a smaller diameter at the outlet end.
However, Dunne teaches an inhaler (Dunne; abstract) including conduits being tapered from a larger diameter at the inlet end to a smaller diameter at the outlet end (jets 20 have holes 21 that are tapered such that the diameter is smaller on the outlet side than the inlet side) (Dunne; Figs. 3-4; para. [0052]; para. [0060]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Braithwaite ‘318 conduits of the jet rings to be tapered from a larger diameter at the inlet end to a smaller diameter at the outlet end, as taught by Dunne, for the purpose of helping to ensure the jets are unbroken before impact with each other (Dunne; para. [0060]).
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Image 3: Annotation of a zoomed-in Braithwaite ‘318 Fig. 6 to illustrate how each conduit, represented by rectangles, is coaxial to the other conduits and has respective outlet ends arranged within respective upstream inlet ends.
Regarding claim 9, the modified Braithwaite ‘318 teaches in which each of the cyclone chambers comprises a conduit having an inlet end and an outlet end, and being tapered from a larger diameter at the inlet end to a smaller diameter at the outlet end (each Braithwaite ‘318 conduit would be modified as taught by Dunne to be tapered such that the diameter is smaller on the outlet side than the inlet side) (Braithwaite ‘318, Figs. 4-6, see annotated Image 3 above; Dunne, Figs. 3-4, para. [0052], para. [0060]).
Regarding claim 10, as best understood, the modified Braithwaite ‘318 teaches in which the conduits are coaxially arranged and in which the outlet end of each of the conduits is nested or arranged within the inlet end of a next-downstream conduit (see annotated Image 3 above).
Regarding claim 20, the modified Braithwaite ‘318 teaches in which each of the cyclone chambers comprises a conduit having an inlet end and an outlet end, and being tapered from a larger diameter at the inlet end to a smaller diameter at the outlet end (each Braithwaite ‘318 conduit would be modified as taught by Dunne to be tapered such that the diameter is smaller on the outlet side than the inlet side) (Braithwaite ‘318, Figs. 4-6, see annotated Image 3 above; Dunne, Figs. 3-4, para. [0052], para. [0060]).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Braithwaite ‘318 as applied to claim 14 above, and further in view of Braithwaite (EP 0 539 469 B1, hereinafter Braithwaite ‘469).
Regarding claim 15, Braithwaite ‘318 discloses the invention as previously claimed, including in the form of an inhaler (amplifying system is fluidly coupled to a dry powder inhaler) (Braithwaite ‘318; para. [0037]; para. [0043]), but is silent on comprising a mouthpiece coupled to the cyclonic-apparatus outlet, wherein the first cyclone chamber is operable to establish the cyclonic flow of fluid between the first cyclone inlet and the first outlet in response to fluid being drawn from the mouthpiece by the inspiratory energy of a patient.
However, Braithwaite ‘318 does teach the inhaler can be a conventionally known inhaler such as described in Braithwaite ‘469 (Braithwaite ‘318; para. [0043]). Moreover, Braithwaite ‘469 teaches an inhaler (Braithwaite ‘469; col. 1, lines 3-5) including a mouthpiece (inhaler comprises a tubular mouthpiece 3) (Braithwaite ‘469; Figs. 1-3; col. 5, lines 24-27).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Braithwaite ‘318 inhaler to include a mouthpiece, as taught by Braithwaite ‘469, for the purpose of providing a specific suitable structure through which air flow and powder can pass through to enter the mouth of a patient (Braithwaite ‘469; Figs. 1-3; col. 7, lines 11-18).
With this modification, the modified Braithwaite ‘318 would thus teach including a mouthpiece coupled to the cyclonic-apparatus outlet, wherein the first cyclone chamber is operable to establish the cyclonic flow of fluid between the first cyclone inlet and the first outlet in response to fluid being drawn from the mouthpiece by the inspiratory energy of a patient (Braithwaite ‘318 dry powder inhaler with a Braithwaite ‘469 tubular mouthpiece 3 would be fluidly coupled to the Braithwaite ‘318 aperture 215; the operation of the Braithwaite ‘318 jets of aerosolized powder can be simultaneous with the inspiration of a patient drawn through the Braithwaite ‘469 tubular mouthpiece 3, and as such the patient inspiration can help to establish the cyclonic flow between the first cyclone inlet and first outlet) (Braithwaite ‘318, abstract, para. [0037], para. [0039], para. [0043]; Braithwaite ‘469, Figs. 1-3, col. 5 lines 24-27; see annotated Images 1-2 above).
Regarding claim 16, the modified Braithwaite ‘318 teaches in the form of a dry-powder inhaler for delivering a dose of the medicament having an active pharmaceutical component (amplifying system is fluidly coupled to a dry powder inhaler, wherein the dose of powder can include active materials) (Braithwaite ‘318; para. [0033]; para. [0037]; para. [0043]; para. [0053]) wherein, in use, the cyclonic apparatus is configured to amplify a pressure reduction caused by a user inhaling through the mouthpiece, and is configured to apply the amplified reduced pressure to the dose to release the active pharmaceutical component and enable the active pharmaceutical component to be inhaled through the mouthpiece (as Braithwaite ‘318 discloses the structure as claimed, it would function for pressure reduction as functionally claimed; in the modified Braithwaite ‘318 apparatus, a patient would inhale through the Braithwaite ‘469 tubular mouthpiece 3, and the reduced pressure for the fluid from the Braithwaite ‘318 dry powder inhaler would be amplified to the dose of powder with the active material such that the dose is inhaled through the Braithwaite ‘469 tubular mouthpiece 3) (Braithwaite ‘318, abstract, para. [0033], para. [0037], para. [0039], para. [0043], para. [0053]; Braithwaite ‘469, Figs. 1-3, col. 5 lines 24-27).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Braithwaite ‘318 as applied to claim 1 above, and further in view of Glusker et al. (US 2019/0015608 A1).
Regarding claim 17, Braithwaite ‘318 discloses the invention as previously claimed, including wherein the cyclonic apparatus inlet is in fluid contact with an inhaler (amplifying system, which is a power delivery device 211 with a gas inlet aperture 214, is fluidly coupled to a dry powder inhaler) (Braithwaite ‘318; Figs. 4-6; para. [0037]; para. [0043]), but does not disclose in which the cyclonic apparatus inlet is in fluid contact with an inhaler deagglomeration engine, such that the first reduced-pressure zone of fluid at the first reduced-pressure inlet is configured to drive the deagglomeration engine.
However, Glusker teaches an inhaler (Glusker; abstract) with an inhaler deagglomeration engine (aerosol engine 50 which functions to deagglomerate powder) (Glusker; Fig. 4; para. [0064]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Braithwaite ‘318 inhaler to include an inhaler deagglomeration engine, as taught by Glusker, for the purpose of helping to further deagglomerate the powder, and thereby further fluidize and aerosolize the powder for delivery to a patient (Glusker; Fig. 4; para. [0064]).
With this modification, the modified Braithwaite ‘318 would thus teach the cyclonic apparatus inlet is in fluid contact with an inhaler deagglomeration engine, such that the first reduced-pressure zone of fluid at the first reduced-pressure inlet is configured to drive the deagglomeration engine (Braithwaite ‘318 gas inlet aperture 214 would fluidly communicate with a Glusker aerosol engine 50, such that the Braithwaite ‘318 first-reduced pressure zone, or vacuum, would drive the Glusker aerosol engine 50 for deagglomerating the powder) (Braithwaite ‘318, Figs. 4-6, para, [0035], para. [0037], para. [0043], para. [0107], para. [0109]; Glusker, Fig. 4, para. [0064]).
Response to Arguments
Applicant's arguments filed 7/2/2026 have been fully considered but they are not persuasive.
On page 9 in the “Drawing Objection” and “Specification Objection” sections of the Applicant’s remarks, the Applicant argues that the drawings and specification have been amended to overcome the objections of the previous office action. The Examiner agrees, and has thus withdrawn those objections.
On page 9 in the “Claim Objections” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the objections of the previous office action. The Examiner agrees, and has thus withdrawn those objections. However, the newly amended claims have raised new claim objections as detailed above.
On page 9 in the “Claim Rejections - 35 U.S.C. 112” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the 35 U.S.C. 112(b) rejections of the previous office action. The Examiner partially agrees, and has thus withdrawn those35 U.S.C. 112(b) rejections which were addressed. However, the unaddressed 35 U.S.C. 112(b) rejections are being maintained, along with new 35 U.S.C. 112(b) rejections raised by the newly amended claims as detailed above.
On pages 10-11 in the “Active vs. Passive Distinction” section of the Applicant’s remarks, the Applicant argues that their invention is a passive system where the cyclonic flow is established by a user inhaling, while Braithwaite ‘318 discloses an active system requiring an external pressurized fluid source to operate, and so Braithwaite ‘318 cannot teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. Firstly, the Applicant’s claimed invention does not preclude the use of an active system having an external pressurized fluid source such as in Braithwaite ‘318. Secondly, the operation of the Braithwaite ‘318 inhaler system coincides with the inspiration of the patient (Braithwaite ‘318; para. [0039]), and as such the patient inspiration would help to establish the cyclonic flow of the powdered medicament out of the device. Thus, the current prior art can still be used to teach the Applicant’s claimed invention.
On pages 11-12 in the “Non-laminar Flow is not the Same as Cyclonic Flow” section of the Applicant’s remarks, the Applicant argues that the non-laminar flow in Braithwaite ‘318 is not the same thing as the cyclonic flow being claimed for the Applicant’s invention, and that there are no structures in Braithwaite ‘318 that would generate a swirling cyclonic flow about an axis as required by claim 1. However, the Examiner respectfully disagrees. The Applicant’s claimed invention is directed to an apparatus, and so the generation of a cyclonic flow is functional. As Braithwaite ‘318 teaches all of the same structures as claimed by the Applicant in claim 1, Braithwaite ‘318 would also inherently function to generate the cyclonic flow as claimed (see MPEP 2112.01(I)). Thus, the current prior art can still be used to teach the Applicant’s claimed invention.
On page 12 in the “Claim Rejections - 35 U.S.C. 103” section of the Applicant’s remarks, the Applicant argues that the secondary references do not cure the previously argued deficiencies of Braithwaite ‘318 with regards to independent claim 1, and as such the dependent claims are allowable. However, the Examiner respectfully disagrees. The Examiner addressed the arguments regarding Braithwaite ‘318 above, and explained that Braithwaite ‘318 can still be used to teach the Applicant’s currently claimed invention. Thus, the secondary references are not needed to cure the argued deficiencies of Braithwaite ‘318, and so the current prior art can still be used to teach the Applicant’s claimed invention.
On page 13 in the “Double Patenting Rejection” section of the Applicant’s remarks, the Applicant requests that the double patenting rejections be held in abeyance until allowable subject matter is indicated. However, as the copending Application No. 19/103,498 was abandoned on 6/11/2026, the double patenting rejections of the previous office action have been rendered moot. The Examiner has thus withdrawn those double patenting rejections until such a time if the application is revived.
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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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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