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 .
Status of the Claims
This Office Action is in responsive to the preliminary amendment filed on 8/11/2023. As directed by the Preliminary amendment, claims 1, 5-9, 11, and 13-14 were amended, and claims 17-20 have been added. Thus, claims 1-20 are currently pending in this application.
Drawings
The drawings are objected to because Fig. 9 contains an unlabeled text box 90 which should be provided with a descriptive text label (e.g. box 90 could have the label --deagglomeration engine--) (see MPEP 608.02(d)(a)). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
The disclosure is objected to because of the following informalities: page 7 in the Applicant’s specification lacks a heading (e.g. Detailed Description of the Invention) to begin the section after the “Preferred Embodiments of the Invention” section in which brief descriptions of the drawings are recited.
Appropriate correction is required.
Claim Objections
Claims 1-20 are objected to because of the following informalities:
Claim 1 recites “the cyclonic-apparatus” in lines 3 and 4, and is suggested to read --the cyclonic apparatus-- (i.e. delete the hyphen) in order to more clearly reference how the limitation was originally claimed.
Claims 2-20 each recite “A cyclonic apparatus according to claim” and are suggested to read --The cyclonic apparatus according to claim-- in order to ensure proper antecedent basis.
Claim 2 recites “each cyclone chamber” in line 9 and is suggested to read --each of the cyclone chambers-- in order to ensure proper antecedent basis.
Claim 2 recites “the cyclonic-apparatus” in line 12, and is suggested to read --the cyclonic apparatus-- (i.e. delete the hyphen) in order to more clearly reference how the limitation was originally claimed.
Claim 5 recites “each cyclone chamber” in line 2 and is suggested to read --each of the cyclone chambers-- in order to ensure proper antecedent basis.
Claim 5 recites “the cyclonic-apparatus” in line 3, and is suggested to read --the cyclonic apparatus-- (i.e. delete the hyphen) in order to more clearly reference how the limitation was originally claimed.
Claim 6 recites “each cyclone chamber” in line 2 and is suggested to read --the first cyclone chamber-- in order to more clearly reference how the limitation was originally claimed.
Claim 9 recites “each cyclone chamber” in line 2 and is suggested to read --each of the cyclone chambers-- in order to ensure proper antecedent basis.
Claim 10 recites “the each conduit” in line 2 and is suggested to read --each of the conduits-- in order to ensure proper antecedent basis and be grammatically correct.
Claim 11 recites “the cyclone inlet of the or each cyclone chamber” in line 2 and is suggested to read --the first cyclone inlet of the first cyclone chamber-- in order to ensure proper antecedent basis and be grammatically correct.
Claim 12 recites “the cyclone inlet of the or each cyclone chamber” in lines 1-2 and is suggested to read --the first cyclone inlet of the first cyclone chamber-- in order to ensure proper antecedent basis and be grammatically correct.
Claim 13 recites “each cyclone chamber” in lines 2-3 and is suggested to read --each of the cyclone chambers-- in order to ensure proper antecedent basis.
Claim 18 recites “each cyclone chamber” in line 1 and is suggested to read --each of the cyclone chambers-- in order to ensure proper antecedent basis.
Claim 18 recites “the cyclonic-apparatus” in line 3, and is suggested to read --the cyclonic apparatus-- (i.e. delete the hyphen) in order to more clearly reference how the limitation was originally claimed.
Claim 20 recites “each cyclone chamber” in line 1 and is suggested to read --each of the cyclone chambers-- in order to ensure proper antecedent basis.
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, 9-13, and 16-19 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 limitations “a cyclone inlet, a reduced-pressure inlet, and an outlet” in lines 3-4, “a cyclonic flow of fluid” in line 5, “a reduced-pressure zone of fluid” in line 6, and “fluid” in line 7, are confusing, as it is unclear whether these are meant to be the same as, include, or be separate from “a first cyclone inlet, a first reduced-pressure inlet, and a first outlet”, “a cyclonic flow of fluid”, “a first reduced-pressure zone of fluid”, and “fluid” in claim 1, respectively. Claim 2 recites the limitations "the next-downstream cyclone chamber" in line 4, “the pressure in the reduced-pressure zone of each cyclone chamber” in line 9, “the pressure in the reduced-pressure zone of the next-downstream cyclone chamber” in lines 9-10, “the cyclone” in line 11, and “the series” in line 11. There is insufficient antecedent basis for these limitations in the claim. Moreover, the limitation “its” in lines 5, 6, and 7 is confusing, as it is unclear as to which limitation is being referenced.
Claim 5 recites the limitation “the series” in line 2. There is insufficient antecedent basis for this limitation in the claim. Moreover, the limitation “its” in line 2 is confusing, as it is unclear as to which limitation is being referenced.
Claim 7 recites the limitation “the cyclones” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation “the next-downstream conduit” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “the cyclone” in line 2. There is insufficient antecedent basis for this limitation in the claim. Moreover, the limitation “that” in line 2 is confusing, as it is unclear as to which limitation is being referenced.
Regarding claim 12, the limitation “that” in line 2 is confusing, as it is unclear as to which limitation is being referenced.
Regarding claim 13, the limitation “two or more cyclone chambers” in line 2 is confusing, as it is unclear as to whether or not this limitation is meant to include the “first cyclone chamber” of claim 1. Moreover, claim 13 recites the limitation “the next-downstream cyclone chamber” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 16, the limitation “a medicament” in line 2 is confusing, as it is unclear whether these are meant to be the same as or different from “a medicament” in claim 14. Claim 16 recites the limitation "the pressure reduction" in line 3. There is insufficient antecedent basis for this limitation in the claim. Moreover, the limitations “amplifies” in line 3 and “applies” in line 4 are confusing, as these are method steps while the claim is an apparatus claim, and thus the scope of the claim is indefinite. The Examiner suggests using claim language such as --configured to-- or adapted for-- in order to avoid such indefiniteness. Furthermore, the limitation “that” in line 5 is confusing, as it is unclear as to which limitation is being referenced.
Regarding claim 17, the limitation “drives” in line 3 is confusing, as this is a method step while the claim is an apparatus claim, and thus the scope of the claim is indefinite. The Examiner suggests using claim language such as --configured to-- or adapted for-- in order to avoid such indefiniteness.
Claim 18 recites the limitation "the series" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Moreover, the limitation “its” in line 2 is confusing, as it is unclear as to which limitation is being referenced.
Claim 19 recites the limitation "the cyclones" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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, and 18-19 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 an inlet and an outlet (amplifying system having an opening for the gas inlet aperture 214 and an aperture 215) (Figs. 4-6; abstract; para. [0107]) and comprising:
a first cyclone chamber having a first cyclone inlet, a first reduced-pressure inlet, the first reduced-pressure inlet forming or in fluid connection with the cyclonic-apparatus inlet, and a 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; jet ring 206 closest to the aperture 215 as the first cyclone chamber) (Figs. 4-6; para. [0107]; para. [0109]; see annotated Images 1-2 below);
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, so as to create a first reduced-pressure zone of fluid at the first reduced-pressure inlet, 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 in response to fluid being drawn from the aperture 215; 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]; para. [0107]; para. [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 cyclone inlet, a reduced-pressure inlet, and an outlet 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 its cyclone inlet and its outlet and to create a reduced-pressure zone of fluid at its inlet in response to fluid being drawn from its 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 cyclone chamber 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 cyclone at an upstream end of the series of cyclones 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 cyclone chamber in the series progressively amplifies, at its reduced-pressure inlet, 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 its 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 each 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, as best understood, Braithwaite ‘318 discloses in which the cyclones 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 11, as best understood, Braithwaite ‘318 discloses in which the cyclone inlet of the or each cyclone chamber is spaced along an axis of the cyclone formed, in use, in that 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, as best understood, Braithwaite ‘318 discloses in which the cyclone inlet of the or each cyclone chamber is tangential to the cyclone formed, in use, in that 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 comprising two or more cyclone chambers arranged in series, in which each cyclone chamber has a higher airflow resistance than the next-downstream cyclone chamber (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, Braithwaite ‘318 discloses a 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 cyclone chamber in the series progressively amplifies, at its reduced-pressure inlet, 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 its 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, as best understood, Braithwaite ‘318 discloses in which the cyclones 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).
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 cyclone chamber 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 the each conduit is nested or arranged within the inlet end of the next-downstream conduit (see annotated Image 3 above).
Regarding claim 20, the modified Braithwaite ‘318 teaches in which each cyclone chamber 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.
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 (Braithwaite ‘318 dry powder inhaler with a Braithwaite ‘469 tubular mouthpiece 3 would be fluidly coupled to the Braithwaite ‘318 aperture 215) (Braithwaite ‘318, para. [0037], para. [0043]; Braithwaite ‘469, Figs. 1-3, col. 5 lines 24-27).
Regarding claim 16, as best understood, the modified Braithwaite ‘318 teaches in the form of a dry-powder inhaler for delivering a dose of a 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 amplifies the pressure reduction caused by a user inhaling through the mouthpiece, and applies the amplified reduced pressure to the dose to release the active pharmaceutical component and enable that 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, as best understood, 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 drives 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 drives 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]).
Double Patenting
Claims 1-3, 5-7, 11-12, and 14-19 of this application is patentably indistinct from claims 1-2, 5, 7-8, 13, 19-20, 28-30, and 32 of Application No. 19/103,498, hereinafter ‘498. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5-7, 11-12, and 14-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 7-8, 13, 19-20, 28-30, and 32 of copending Application No. 19/103,498, hereinafter ‘498 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, ‘498 discloses a cyclonic apparatus having an inlet and an outlet (negative pressure amplifier apparatus with a first amplifier chamber, which is a cyclone chamber; the apparatus has an apparatus outlet and an apparatus inlet) (‘498; claims 1, 5, 7) and comprising:
a first cyclone chamber having a first cyclone inlet, a first reduced-pressure inlet, the first reduced-pressure inlet forming or in fluid connection with the cyclonic-apparatus inlet (first amplifier chamber has a first amplifier inlet, a fist primary inlet, and a first outlet, which are used to create reduced pressure; first amplifier inlet is in fluid communication with the apparatus inlet) (‘498; claims 1, 5, 7), and a first outlet forming the cyclonic-apparatus outlet (first outlet forms or is in fluid communication with the apparatus outlet) (‘498; claim 1);
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, so as to create a first reduced-pressure zone of fluid at the first reduced-pressure inlet, in which the first reduced-pressure inlet is at an axial position downstream of the first cyclone inlet in the first cyclone chamber (first amplifier chamber is a first cyclone chamber operable to establish a cyclonic first primary fluid flow between the first primary inlet and the first outlet in response to fluid being drawn from the first outlet; first amplifier chamber is configured to create a first reduced-pressure zone of fluid at the first amplifier inlet; first amplifier inlet is positioned downstream of the first primary inlet) (‘498; claims 1, 7).
Regarding claim 2, as best understood, ‘498 discloses comprising: one or more further cyclone chambers arranged in series upstream of the first cyclone chamber, each further cyclone chamber having a cyclone inlet, a reduced-pressure inlet, and an outlet coupled to the reduced-pressure inlet of the next-downstream cyclone chamber (a second amplifier chamber is upstream of the first amplifier chamber, and has a second amplifier inlet, a second primary inlet, and a second outlet which forms or is in fluid communication with the first amplifier inlet; the second amplifier chamber is a second cyclonic chamber) (‘498; claims 1, 19); each further cyclone chamber being operable to establish a cyclonic flow of fluid between its cyclone inlet and its outlet and to create a reduced-pressure zone of fluid at its inlet in response to fluid being drawn from its outlet by the reduced-pressure zone of fluid in the next-downstream cyclone chamber (second amplifier chamber to establish a second cyclonic primary fluid flow between the second primary inlet and the second outlet in response to fluid being drawn from the second outlet; second amplifier chamber is to create a second reduced-pressure zone of fluid at the second amplifier inlet; the second outlet forms or is in fluid communication with the downstream first amplifier inlet which has a first reduced-pressure zone) (‘498; claims 1, 19); in which 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 (pressure drop between the first outlet and the first amplifier inlet, such that the first amplifier inlet has a negative pressure greater in magnitude that the outlet negative pressure; a negative number with a greater magnitude is less than a negative number with a lesser magnitude when you take into account direction, e.g. -10 is lesser in value than -5, even though the magnitude of -10 is greater than the magnitude -5) (‘498; claims 1, 2, 19); and in which the reduced-pressure inlet of the cyclone at an upstream end of the series of cyclones forms the cyclonic-apparatus inlet (the upstream second amplifier inlet is a part of the apparatus that receives air, and so could be the apparatus inlet) (‘498; claim 1).
Regarding claim 3, ‘498 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 amplifier chamber is upstream of the first amplifier chamber, and has a second amplifier inlet, a second primary inlet, and a second outlet which forms or is in fluid communication with the first amplifier inlet; the second amplifier chamber is a second cyclonic chamber) (‘498; claims 1, 19), 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 (second amplifier chamber to establish a second cyclonic primary fluid flow between the second primary inlet and the second outlet in response to fluid being drawn from the second outlet; second amplifier chamber is to create a second reduced-pressure zone of fluid at the second amplifier inlet; the second outlet forms or is in fluid communication with the downstream first amplifier inlet which has a first reduced-pressure zone) (‘498; claims 1, 19), wherein the fluid in the second reduced-pressure zone is at a lower pressure than the fluid in the first reduced-pressure zone (pressure drop between the first outlet and the first amplifier inlet, such that the first amplifier inlet has a negative pressure greater in magnitude that the outlet negative pressure; a negative number with a greater magnitude is less than a negative number with a lesser magnitude when you take into account direction, e.g. -10 is lesser in value than -5, even though the magnitude of -10 is greater than the magnitude -5; the second reduced-pressure zone would thus be lower than the pressure in the downstream first reduced-pressure zone) (‘498; claims 1, 2, 19).
Regarding claim 5, as best understood, ‘498 discloses in which each cyclone chamber in the series progressively amplifies, at its reduced-pressure inlet, a reduced pressure applied, in use, to the cyclonic-apparatus outlet (pressure drop between the first outlet and the first amplifier inlet, such that the first amplifier inlet has a negative pressure greater in magnitude that the outlet negative pressure; a negative number with a greater magnitude is less than a negative number with a lesser magnitude when you take into account direction, e.g. -10 is lesser in value than -5, even though the magnitude of -10 is greater than the magnitude -5) (‘498; claims 1, 2, 19).
Regarding claim 6, ‘498 discloses in which each cyclone chamber is unidirectional (first and second amplifier chambers are uniflow) (‘498; claims 8, 20).
Regarding claim 7, as best understood, ‘498 discloses in which the cyclones are arranged coaxially with each other (first and second amplifier chambers are aligned coaxially) (‘498; claim 13).
Regarding claim 11, as best understood, ‘498 discloses in which the cyclone inlet of the or each cyclone chamber is spaced along an axis of the cyclone formed, in use, in that cyclone chamber (first and second amplifier chambers are aligned coaxially, and so are spaced along the axis of the cyclone formed in the respective cyclone chambers) (‘498; claim 13).
Regarding claim 12, as best understood, ‘498 discloses in which the cyclone inlet of the or each cyclone chamber is tangential to the cyclone formed, in use, in that cyclone chamber (first primary inlet is a tangential inlet to the swirling flow in the first amplifier chamber) (‘498; claim 8).
Regarding claim 14, ‘498 discloses a 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 (inhaler with negative pressure amplification apparatus of claim 7 that has an apparatus inlet is coupled to a source of medicament) (‘498; claims 1, 28).
Regarding claim 15, ‘498 discloses in the form of an inhaler, comprising a mouthpiece coupled to the cyclonic-apparatus outlet (inhaler comprises a mouthpiece surrounding the first outlet, which forms the apparatus outlet) (‘498; claims 1, 32).
Regarding claim 16, as best understood, ‘498 discloses in the form of a dry-powder inhaler for delivering a dose of a medicament having an active pharmaceutical component (inhaler is a dry powder inhaler and medicament is a dose of dry powdered medicament) (‘498; claim 29) wherein, in use, the cyclonic apparatus amplifies the pressure reduction caused by a user inhaling through the mouthpiece, and applies the amplified reduced pressure to the dose to release the active pharmaceutical component and enable that component to be inhaled through the mouthpiece (the negative pressure amplification apparatus has amplifier chambers to amplify the negative pressure so that the negative pressure becomes less negative between the inlet to the first outlet at the mouthpiece through which a user would inhale, thereby increasing the pressure; the amplified pressure would be applied to the medicament in the apparatus to be inhaled) (‘498; claims 1, 32).
Regarding claim 17, as best understood, ‘498 discloses 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 drives the deagglomeration engine (deagglomeration engine is between the amplifier inlet and source of medicament, and so would be driven be the first amplification chamber with its first reduced-pressure zone) (‘498; claims 1, 30).
Regarding claim 18, as best understood, ‘498 discloses in which each cyclone chamber in the series progressively amplifies, at its reduced-pressure inlet, a reduced pressure applied, in use, to the cyclonic-apparatus outlet (the first amplifier chamber generates a pressure drop so that the negative pressure becomes less negative between the first amplifier inlet to the first outlet, thereby increasing the pressure; the second amplifier chamber has the same structure as the first, and so would be able to function in the same way) (‘498; claims 1-2).
Regarding claim 19, as best understood, ‘498 discloses in which the cyclones are arranged coaxially with each other (first and second amplifier chambers are aligned coaxially) (‘498; claim 13).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2011/0094507 A1 by Wachtel is considered to be relevant as it discloses an inhaler with side inlets for aerosolizing a vortex of air and powder.
US 2021/0402113 A1 by Cocker et al. is considered to be relevant as it discloses a dry powder inhaler with angled side inlets for creating a cyclone of powder and air.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785