DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This action is in response to the filing on 7/28/2025. Since the previous filing, no claims have been added, amended or cancelled. Thus, claims 1-23 are pending in the application.
In regards to the previous 103 rejections, Applicant has not amended and their argument do not overcome the prior art previously applied and these rejections are maintained below.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 61/601400, 61664013, 13/773325 and 13/776546, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. None of the listed applications, provisional or otherwise, provide support for the limitation of the “grid” nor any of the associated functionality as described in independent claims 1, 10 and 15. Accordingly, independent claims 1, 10 and 15 as well as dependent claims 2-9, 11-14 and 16-23 of the instant application are not entitled to the benefit of the prior applications.
The earliest application with the stated limitations is 64/486183, filed on 4/17/2017. Therefore, the earliest priority date of the instant application is 4/17/2017.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) 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.
Claims 1, 4, 5, 6, 8-14 and 21-23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cocozza (US Patent No. 3,991,761) in view of Haerder (US Patent No. 9,010,323), Donovan (US Patent Publication No. 2012/0145150), Giroux (US Patent No. 7,905,229), Horlin (US Patent No. 6,230,707) and Ahern (US Patent Publication No. 2018/0043111).
In regards to claim 1, Cocozza teaches a unit dose dry powder inhaler (abstract), comprising: an inhaler base defining a capsule seat that is configured to hold a capsule containing a powdered medicament (column 1 line 12-14), the inhaler base comprising: at least one primary air intake that is in fluid communication with the capsule seat, wherein the primary air intake is configured to draw air into the capsule seat so as to generate rapid capsule precession and centrifugal forces that fluidize and disperse powder agglomerates (column 1 line 15-20, column 3 line 49-59, column 5 line 24-27, Fig 6 elements 10 and 12), wherein the rapid capsule precession comprises rotation of the capsule in a plane that is substantially orthogonal to the longitudinal axis of the inhaler (column 5 line 24-27, Fig 6); a grid positioned between the inhaler base and a mouthpiece, wherein entrained powder is drawn through the grid resulting in dispersion of powder agglomerates via impaction forces with the static grid (column 3 line 63- 65, column 5, lines 17-37; Fig 1 element 1).
While Cocozza does not explicitly teach that the grid aligns airflow, it is taught by Ahern that it is known in inhalers that a mesh may produce a laminar (i.e.: aligned) airflow (paragraph 31). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the grid of Cocozza to serve as a flow straightener as taught by Ahern as this would direct airflow and entrained powder in a common direction through the flow path which would help prevent powder impacting the sidewalls of the device and potentially leaving deposits which might clog the device or impact delivered dose levels.
Cocozza does not teach that the grid is a mesh grid, an inlet funnel positioned between the grid and a dispersion chamber such that an inlet side of the inlet funnel is downstream of the grid, wherein the inlet funnel tapers to a small inlet orifice into the dispersion chamber resulting in dispersion of powder agglomerates via shear forces generated at the orifice, an outlet funnel through which air and aerosolized medicament exit the inhaler to be delivered to a patient, wherein the outlet funnel is tapered reduce minimize particle velocity and turbulence at an exit of the mouthpiece to the patient or that the dispersion chamber that is adapted to entrain powder from the inlet funnel, the dispersion chamber holding an actuator that is configured to oscillate within the dispersion chamber during inhalation resulting in dispersion of powder agglomerates by dynamic impaction with the actuator and increased turbulence within the dispersion chamber, wherein a ratio of (a) a diameter of the inlet funnel at a connection with the dispersion chamber and (b) a diameter of the dispersion chamber is between 0.4 and 0.6 to optimize the oscillation of the actuator.
However, Haerder teaches that the grid is a mesh grid (column 1 line 55-56 and column 2 line 34-36), an inlet funnel positioned between the grid and a dispersion chamber such that an inlet side of the inlet funnel is downstream of the grid (while not identified as a dispersion chamber, air shaft 6 occupies the same structural location and has been used to judge relative positions of relevant features, Fig 1 element 6 and 11), wherein the inlet funnel tapers to a small inlet orifice into the dispersion chamber resulting in dispersion of powder and agglomerates via shear forces generated at the orifice (Fig 1 element 6 and 11), an outlet funnel through which air and aerosolized medicament exit the inhaler to be delivered to a patient, wherein the outlet funnel is tapered (column 3 line 9, Fig 1 element 4).
While the inlet funnel of Haerder is not elongate nor does Haerder state the reason for tapering the inlet and outlet funnels, Donovan shows an inlet funnel that is elongate (Fig 7 shows the height of inlet funnel 704 as 8 and greater than its largest width at 7.6, see Annotated Fig 7-2), Giroux teaches the obviousness of modifying the dimensions of the inlet components to achieve desired particle size or delivery rate (column 11 line 24-30) and Horlin teaches the obviousness of modifying the inlet funnel shape to tapper as this enhances velocity of entrained particles, increasing interparticle bombardment and leading to better uniformity of dispersion and lower particle size (column 4 line 35-41) and widening the outlet funnel decrease particle velocity, resulting in better delivery of powder medicament to the lungs (column 4 line 48-52).
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 Cocozza such that the grid is a mesh grid, an inlet funnel positioned between the grid and a dispersion chamber such that an inlet side of the inlet funnel is downstream of the grid as taught by Haerder as this would isolate the capsule chamber and ensure that any potential blockages due to capsule fragments or accumulated powder residue would be easily removed from the grid and to modify the shapes of the inlet and outlet funnels as taught by Donovan, Giroux and Horlin as these modifications would ensure effective delivery of medicament to the patient.
Further, Donovan teaches the dispersion chamber is adapted to entrain powder from the inlet funnel, the dispersion chamber holding an actuator that is configured to oscillate within the dispersion chamber during inhalation resulting in dispersion of powder agglomerates by dynamic impaction with the actuator and increased turbulence within the dispersion chamber (abstract, paragraph 89 line 1 paragraph 91, Fig 2A element 201 and 202) and wherein a ratio of (a) a diameter of the inlet funnel at a connection with the dispersion chamber and (b) a diameter of the dispersion chamber is between 0.4 and 0.6 to optimize the oscillation of the actuator (Fig 72 shows diameter of the inlet funnel at a connection to the dispersion chamber as 3.5 and the diameter of the dispersion chamber as 7.6 yielding a ratio of 0.46).
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 Cocozza such that the dispersion chamber is adapted to entrain powder from the inlet funnel, the dispersion chamber holding an actuator that is configured to oscillate within the dispersion chamber during inhalation resulting in dispersion of powder agglomerates by dynamic impaction with the actuator and increased turbulence within the dispersion chamber and wherein a ratio of (a) a diameter of the inlet funnel at a connection with the dispersion chamber and (b) a diameter of the dispersion chamber is between 0.4 and 0.6 to optimize the oscillation of the actuator as taught by Donovan as this would break apart any potential clumps of powder to ensure that the particles are of appropriate size for effective delivery to the patient and the diameters and ratios represent variables that may be optimized through routine experimentation (see MPEP 2144.05 II A). With respect to routine optimization, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges which result from routine experimentation.
In regards to claim 4, Cocozza in view of Haerder, Donovan, Giroux, Horlin and Ahern teaches the device of claim 1.
Cocozza does not teach wherein the inlet and outlet funnels have a conical frustum shape.
However, Haerder teaches wherein the inlet and outlet funnels have a conical frustum shape (Fig 1 element 4 and 11).
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 Cocozza such that the inlet and outlet funnels have a conical frustum shape as taught by Haerder as modifying the shape of the inlet to tapper enhances the velocity of entrained particles, increasing interparticle bombardment and leading to better uniformity of dispersion and lower particle size (Horlin: column 4 line 35-41) and widening the outlet funnel decreases particle velocity, resulting in better delivery of powder medicament to the lungs (Horlin: column 4 line 48-52).
In regards to claim 5, Cocozza in view of Haerder, Donovan, Giroux, Horlin and Ahern teaches the device of claim 1.
Cocozza does not teach that the inhaler has airflow bypass channels.
However, Donovan teaches that the inhaler has airflow bypass channels (page 7 paragraph 103 line 6, Fig 5B elements 503 and 504).
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 Cocozza to have airflow bypass channels as taught by Donovan as they decrease the resistance characteristics of the inhaler and may aid patients unable to inhale strongly enough to overcome greater resistance values.
In regards to claim 6, Cocozza in view of Haerder, Donovan, Giroux, Horlin and Ahern teaches the device of claim 1 and Cocozza further teaches that the inhaler does not have airflow bypass channels (Fig 11).
In regards to claim 8, Cocozza in view of Haerder, Donovan, Giroux, Horlin and Ahern teaches the device of claim 1.
Cocozza does not teach that there is a retaining member situated between the dispersion chamber and the outlet shaft.
However, Donovan teaches that there is a retaining member situated between the dispersion chamber and the outlet shaft (abstract, page 6 paragraph 89 line 15-19).
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 Cocozza such that there is a retaining member situated between the dispersion chamber and the outlet shaft as taught by Donovan as this prevents the actuator inside the dispersion chamber from being dislodged during inhalation.
In regards to claim 9, Cocozza in view of Haerder, Donovan, Giroux Horlin and Ahern teaches the device of claim 1 and Cocozza further teaches that the inlet side of the inlet funnel is sized such that it exposes substantially all of the grid (lower face 34 wider than grating 1, Fig 1).
In regards to claim 10, Cocozza teaches a unit does dry powder inhaler, comprising: an inhaler base defining a capsule seat that is configured to hold a capsule containing a powdered medicament (column 1 line 12-14), the inhaler base comprising: at least one piercing member that is configured to pierce the capsule upon actuation (column 1 line 14-15); at least one primary air intake that is in fluid communication with the capsule seat, wherein the primary air intake is configured to draw air into the capsule seat upon piercing the capsule so as to generate rapid capsule precession and centrifugal forces that fluidize and disperse powder agglomerates (column 1 line 15-20, column 3 line 49-50, column 5 line 24-27, Fig 6 elements 10 and 12), wherein the rapid capsule precession comprises rotation of the capsule about a longitudinal axis of the inhaler while a longitudinal axis of the capsule is substantially orthogonal to the longitudinal axis of the inhaler (column 5 line 24-27, Fig 6); a grid positioned between the inhaler base and a mouthpiece, wherein entrained powder is drawn through the grid resulting in dispersion of powder agglomerates via impaction forces with the static grid (column 3 line 63-65, column 5, lines 17-37, Fig 1 element 1).
While Cocozza does not explicitly teach that the grid aligns airflow, it is taught by Ahern that it is known in inhalers that a mesh may produce a laminar (i.e.: aligned) airflow (paragraph 31). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the grid of Cocozza to serve as a flow straightener as taught by Ahern as this would direct airflow and entrained powder in a common direction through the flow path which would help prevent powder impacting the sidewalls of the device and potentially leaving deposits which might clog the device or impact delivered dose levels.
Cocozza does not teach that the grid is a mesh grid, an inlet funnel positioned between the grid and a dispersion chamber such that an inlet side of the inlet funnel is downstream of the grid, wherein the inlet funnel tapers to a small inlet orifice into the dispersion chamber resulting in dispersion of powder agglomerates via shear forces generated at the orifice, an outlet funnel through which air and aerosolized medicament exit the inhaler to be delivered to a patient, wherein the outlet funnel is tapered to reduce particle velocity and turbulence at an exit of the mouthpiece to the patient or that the dispersion chamber that is adapted to entrain powder from the inlet funnel, the dispersion chamber holding an actuator that is configured to oscillate within the dispersion chamber during inhalation resulting in dispersion of powder agglomerates by dynamic impaction with the actuator and increased turbulence within the dispersion chamber, wherein a ratio of (a) a diameter of the inlet funnel at a connection with the dispersion chamber and (b) a diameter of the dispersion chamber is between 0.4 and 0.6 to optimize the oscillation of the actuator.
However, Haerder teaches that the grid is a mesh grid (column 1 line 55-56 and column 2 line 34-36), an inlet funnel positioned between the grid and a dispersion chamber such that an inlet side of the inlet funnel is downstream of the grid (while not identified as a dispersion chamber, air shaft 6 occupies the same structural location and has been used to judge relative positions of relevant features, Fig 1 element 6 and 11), wherein the inlet funnel tapers to a small inlet orifice into the dispersion chamber resulting in dispersion of powder agglomerates via shear forces generated at the orifice (Fig 1 element 6 and 11) and an outlet funnel through which air and aerosolized medicament exit the inhaler to be delivered to a patient, wherein the outlet funnel is tapered to reduce particle velocity and turbulence at an exit of the mouthpiece to the patient (column 3 line 9, Fig 1 element 4).
While the inlet funnel of Haerder is not elongate, Donovan shows an inlet funnel that is elongate (Fig 7 shows the height of inlet funnel 704 as 8 and greater than its largest width at 7.6, see Annotated Fig 7-2), Giroux teaches the obviousness of modifying the dimensions of the inlet components to achieve desired particle size or delivery rate (column 11 line 24-30). 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 Cocozza such that the grid is a mesh grid, an inlet funnel positioned between the grid and a dispersion chamber such that an inlet side of the inlet funnel is downstream of the grid, wherein the inlet funnel tapers to a small inlet orifice into the dispersion chamber resulting in dispersion of powder agglomerates via shear forces generated at the orifice, an outlet funnel through which air and aerosolized medicament exit the inhaler to be delivered to a patient, wherein the outlet funnel is tapered as taught by Haerder as these configurations would ensure that the particle size is suitable for effective delivery to the patient. Further, it would be obvious to modify inlet funnel shape to tapper as this enhances velocity of entrained particles, increasing interparticle bombardment and leading to better uniformity of dispersion and lower particle size (Horlin: column 4 line 35-41) and widening the outlet funnel decrease particle velocity, resulting in better delivery of powder medicament to the lungs (Horlin: column 4 line 48-52).
Further, Donovan teaches the dispersion chamber that is adapted to entrain powder from the inlet funnel, the dispersion chamber holding an actuator that is configured to oscillate within the dispersion chamber during inhalation resulting in dispersion of powder agglomerates by dynamic impaction with the actuator and increased turbulence within the dispersion chamber (abstract, paragraph 89 line 1, paragraph 91, Fig 2A element 201 and 202), wherein the dispersion chamber comprises a step increase in diameter relative to the small inlet orifice (Fig 2A element 201 and 202) and wherein a ratio of (a) a diameter of the inlet funnel at a connection with the dispersion chamber and (b) a diameter of the dispersion chamber is between 0.4 and 0.6 to optimize the oscillation of the actuator (Fig 72 shows diameter of the inlet funnel at a connection to the dispersion chamber as 3.5 and the diameter of the dispersion chamber as 7.6 yielding a ratio of 0.46).
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 Cocozza with a dispersion chamber adapted to entrain powder from the inlet funnel containing an oscillating actuator configured to oscillate on inhalation to increase turbulence within chamber and further disperse powdered medicament via dynamic impaction between the inlet and outlet funnels, the dispersion chamber having a wider diameter than the outlet of the inlet funnel and wherein a ratio of (a) a diameter of the inlet funnel at a connection with the dispersion chamber and (b) a diameter of the dispersion chamber is between 0.4 and 0.6 to optimize the oscillation of the actuator as taught by Donovan as this would break apart any clumps of medicament powder that might impede delivery to the patient.
In regards to claim 11, Cocozza in view of Haerder, Donovan, Giroux, Horlin and Ahern teaches the device of claim 10.
Cocozza does not teach that the inlet funnel and the dispersion chamber are a single unit configured to couple with the outlet funnel.
However, Donovan teaches that the inlet funnel and the dispersion chamber are a single unit configured to couple with the outlet funnel (paragraph 105 line 9-11, Fig 7 elements 702 (outlet funnel), 703 (single unit), 704 (inlet funnel) and 705 (dispersion chamber)).
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 Cocozza such that the inlet funnel and the dispersion chamber are a single unit configured to couple with the outlet funnel as taught by Donovan as this would make construction and assembly easier and more efficient.
In regards to claim 12, Cocozza in view of Haerder, Donovan, Giroux, Horlin and Ahern teaches the device of claim 11.
Cocozza does not teach that the inhaler body comprises an outlet funnel, wherein the single unit is configured to be inserted within the inhaler body to couple the dispersion chamber with the outlet funnel.
However, Donovan teaches that the inhaler body comprises an outlet funnel (Fig 7 element 702 (outlet funnel) and 701 (inhaler body)) and wherein the single unit is configured to be inserted within the inhaler body to couple the dispersion chamber with the outlet funnel (Fig 7 element 703, see Annotated Fig 71).
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Annotated Fig 71
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 Cocozza to comprise an outlet funnel, wherein the single unit is configured to be inserted within the inhaler body to couple the dispersion chamber with the outlet funnel as taught by Donovan to help ensure that no powder medicament could escape the device through any path other than delivery to the patient.
In regards to claim 13, Cocozza in view of Haerder, Donovan, Giroux, Horlin and Ahern teaches the device of claim 12.
Cocozza does not teach that the inhaler body is configured to receive a flange attached to the grid element such that the grid is positioned between the inlet funnel and the base once the single unit is inserted into the inhaler body.
However, Haerder teaches that the inhaler body is configured to receive a flange attached to the grid element such that the grid is positioned between the inlet funnel and the base once the single unit is inserted into the inhaler body (column 3 line 13-15, Fig 2 elements 7, 9, 10 and 11).
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 Cocozza such that the inhaler body is configured to receive a flange attached to the grid as taught by Hearder as this would ensure proper attachment between components on assembly so as to ensure no powder is able to escape through any path other than the intended delivery path to the patient.
In regards to claim 14, Cocozza in view of Haerder, Donovan, Giroux, Horlin and Ahern teaches the device of claim 10.
Cocozza does not teach that the grid has a rim configured to receive at least a portion of the upstream end of the inlet funnel.
However, Haerder teaches that the grid has a rim configured to receive at least a portion of the upstream end of the inlet funnel (column 3 line 13-15, Fig 2 elements 9, 10 and 11).
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 Cocozza such that the grid has a rim configured to receive at least a portion of the upstream end of the inlet funnel as taught by Hearder as this would ensure proper attachment between components on assembly so as to ensure no powder is able to escape through any path other than the intended delivery path to the patient.
In regards to claim 21, Cocozza in view of Haerder, Donovan, Giroux, Horlin and Ahern teaches the device of claim 1.
Cocozza does not teach that a grid side of the inlet funnel has a diameter of between about 10 mm and 20 mm.
However, Haerder teaches the diameter of the grid is between 10 mm and 20 mm (dimensions of sieve area are between 5 mm and 15 mm, column 2 line 13-15).
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 Cocozza such that the diameter is between 10 mm and 20 mm as taught by Haerder as an individual of ordinary skill would reasonably consider this size range to fit within an inhaler and to effectively cover the opening to the inlet funnel while providing efficient passage for the medicament and the courts have held that in 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)).
In regards to claim 22, Cocozza in view of Haerder, Donovan, Giroux, Horlin and Ahern teaches the device of claim 1.
Cocozza does not teach that the diameter of the inlet orifice is between 2.4 and 4 mm.
However, Donovan teaches the diameter of the inlet orifice is between 2.4 and 4 mm (paragraph 107 establishes dimensions given in millimeters, see Annotated Fig 72).
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Annotated Fig 72
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 Cocozza such that the diameter of the inlet orifice is between 2.4 and 4 mm as taught by Donovan as modifying the dimensions of the inlet components would achieve desired particle size or delivery rate (Giroux: column 11 line 24-30) and the courts have held that in 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)).
In regards to claim 23, Cocozza in view of Haerder, Donovan, Giroux, Horlin and Ahern teaches the device of claim 1.
Cocozza does not teach that the outlet funnel has a diameter of between about 8 mm and 14 mm.
However, Donovan teaches that the outlet funnel has a diameter of between about 8 mm and 14 mm (paragraph 107 establishes dimensions given in millimeters, see Annotated Fig 72).
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 Cocozza such that the outlet funnel has a diameter of between about 8 mm and 14 mm as widening the outlet funnel decrease particle velocity, resulting in better delivery of powder medicament to the lungs (Horlin: column 4 line 48-52) and the courts have held that in 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)).
Claims 2, 3 and 7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cocozza (US Patent No. 3,991,761) in view of Haerder (US Patent No. 9,010,323), Donovan (US Patent Publication No. 2012/0145150), Giroux (US Patent No. 7,905,229), Horlin (US Patent No. 6,230,707) and Ahern (US Patent Publication No. 2018/0043111) as applied to claim 1 above, and in further view of Zierenberg (US Patent No. 8,022,082).
In regards to claim 2, Cocozza in view of Haerder, Donovan, Giroux, Horlin and Ahern teaches the device of claim 1.
Cocozza does not teach an inhaler with a high airflow resistance between about 0.14 and 0.25 cmH2O0.5L-1min.
However, Zierenberg teaches an inhaler with a high airflow resistance between about 0.14 and 0.25 cmH2O0.5L-1min (abstract, column 12 claim 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to calibrate the inhaler of Cocozza for a desired range of airflow resistance as taught by Zierenberg as these values are known for effective delivery of medication to small airways (particles sized for intended delivery to the deep lung regions, column 1 line 65 – column 2 line 2, preferred range to achieve effective delivery of particles of appropriate size, column 3 line 56-59).
In regards to claim 3, Cocozza in view of Haerder, Donovan, Giroux, Horlin and Ahern teaches the device of claim 1.
Cocozza does not teach an inhaler that has a high airflow resistance between about 0.16 and 0.19 cmH2O0.5L-1min.
However, Zierenberg teaches an inhaler with a high airflow resistance between about 0.16 and 0.19 cmH2O0.5L-1min (column 12 claim 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to calibrate the inhaler of Cocozza for a desired range of airflow resistance as taught by Zierenberg as these values are known for effective delivery of medication to small airways (particles sized for intended delivery to the deep lung regions, column 1 line 65 – column 2 line 2, preferred range to achieve effective delivery of particles of appropriate size, column 3 line 56-59).
In regards to claim 7, Cocozza in view of Haerder, Donovan, Giroux, Horlin and Ahern teaches the device of claim 1.
Cocozza does not teach that the aerosolized medicament comprises particles having an impaction parameter that enables improved delivery to patient airways of less than about 2 mm in internal diameter.
However, Zierenberg teaches that the aerosolized medicament comprises particles having an impaction parameter that enables improved delivery to patient airways of less than about 2 mm in internal diameter (inhaler dispersion methods results in particles with properties sufficient to deliver medicament to the deep lung region, column 1 line 65 – column 2 line 2).
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 Cocozza such that the aerosolized medicament comprises particles having an impaction parameter that enables improved delivery to patient airways of less than about 2 mm in internal diameter as taught by Zierenberg as this greatly increases the effectiveness of the delivered medicament.
Claims 15 and 17-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cocozza (US Patent No. 3,991,761) in view of Haerder (US Patent No. 9,010,323), Donovan (US Patent Publication No. 2012/0145150), Giroux (US Patent No. 7,905,229) and Ahern (US Patent Publication No. 2018/0043111).
In regards to claim 15, Cocozza teaches a method for aerosolizing a powdered medicament, comprising: providing an inhaler comprising: a base defining a capsule seat that is configured to hold a capsule containing a powdered medicament (column 1 line 12-14) and comprising at least one primary air intake in fluid communication with the capsule seat (column 1 line 15-20, Fig 6 element 10 and 12); a grid (Fig 1 element 1), introducing air into the capsule seat via the at least one primary air intake to generate rapid capsule precession and centrifugal forces to entrain powder within the air; generate rapid capsule precession and centrifugal forces that fluidize and disperse powder agglomerates, wherein the rapid capsule precession comprises rotation of the capsule in a plane that is substantially orthogonal to the longitudinal axis of the inhaler (column 1 line 15-20, column 3 line 49-50, column 5 line 24-27, Fig 6), drawing the entrained powder through the grid so as to impact at least a portion of the powdered medicament against the grid to disperse the at least a portion of the powdered medicament (column 3 line 63-65).
While Cocozza does not explicitly teach that the grid align airflow, it is taught by Ahern that it is known in inhalers that a mesh may produce a laminar (i.e.: aligned) airflow (paragraph 31). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the grid of Cocozza to serve as a flow straightener as taught by Ahern as this would direct airflow and entrained powder in a common direction through the flow path which would help prevent powder impacting the sidewalls of the device and potentially leaving deposits which might clog the device or impact delivered dose levels.
Cocozza does not teach that the grid is a mesh grid that is disposed between the base and an inlet side of an inlet funnel, the inlet funnel positioned between the grid and a dispersion chamber such that an inlet side of the inlet funnel is downstream of the grid, an outlet funnel through which air and aerosolized medicament exit the inhaler to be delivered to a patient or a dispersion chamber holding an actuator that is configured to oscillate within the dispersion chamber during inhalation; and dispersing powder agglomerates via increasing shear force produced by air flowing through the inlet funnel as the air approaches the dispersion chamber; generating dynamic impaction and turbulent forces by inducing air to flow through the dispersion chamber to cause the actuator to oscillate within the dispersion chamber to disperse powder agglomerates; and delivering the dispersed powder agglomerates to the patient’s airway via the outlet funnel, and wherein a ratio of (a) a diameter of the inlet funnel at a connection with the dispersion chamber and (b) a diameter of the dispersion chamber is between 0.4 and 0.6 to optimize the oscillation of the actuator.
However, Haerder teaches that the grid is a mesh grid (column 1 line 55-56 and column 2 line 34-36) that is disposed between the base and an inlet side of an inlet funnel (Fig 1 element 1 and 11). an inlet funnel positioned between the grid and a dispersion chamber such that an inlet side of the inlet funnel is downstream of the grid (while not identified as a dispersion chamber, air shaft 6 occupies the same structural location and has been used to judge relative positions of relevant features, Fig 1 element 6 and 11), and an outlet funnel through which air and aerosolized medicament exit the inhaler to be delivered to a patient (column 3 line 9, Fig 1 element 4).
While the inlet funnel of Haerder is not elongate, Donovan shows an inlet funnel that is elongate (Fig 7 shows the height of inlet funnel 704 as 8 and greater than its largest width at 7.6, see Annotated Fig 7-2) and Giroux teaches the obviousness of modifying the dimensions of the inlet components to achieve desired particle size or delivery rate (column 11 line 24-30).
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 Cocozza with a grid that is a two dimensional mesh and that is disposed between the base and the inlet side of an inlet funnel and an outlet funnel through which air and aerosolized medicament exit the inhaler to be delivered to a patient as taught by Haerder as the position of the grid would make cleaning the device and removing any potential obstructions in the grid easier while the configuration of the outlet funnel would ensure that all medicament would be directed to the patient and to modify the shape of the inlet funnel as taught by Donovan and Giroux as such modification would help ensure effective delivery of medicament to the patient.
Further, Donovan teaches a dispersion chamber holding an actuator that is configured to oscillate within the dispersion chamber during inhalation; and dispersing powder agglomerates via increasing shear force produced by air flowing through the inlet funnel as the air approaches the dispersion chamber; generating dynamic impaction and turbulent forces by inducing air to flow through the dispersion chamber to cause the actuator to oscillate within the dispersion chamber to disperse powder agglomerates; and delivering the dispersed powder agglomerates to the patient’s airway via the outlet funnel (abstract, paragraph 89 line 1, paragraph 91, Fig 2A element 201 and 202) and wherein a ratio of (a) a diameter of the inlet funnel at a connection with the dispersion chamber and (b) a diameter of the dispersion chamber is between 0.4 and 0.6 to optimize the oscillation of the actuator (Fig 72 shows diameter of the inlet funnel at a connection to the dispersion chamber as 3.5 and the diameter of the dispersion chamber as 7.6 yielding a ratio of 0.46).
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 Cocozza with a dispersion chamber holding an actuator that is configured to oscillate within the dispersion chamber during inhalation; and dispersing powder agglomerates via increasing shear force produced by air flowing through the inlet funnel as the air approaches the dispersion chamber; generating dynamic impaction and turbulent forces by inducing air to flow through the dispersion chamber to cause the actuator to oscillate within the dispersion chamber to disperse powder agglomerates; and delivering the dispersed powder agglomerates to the patient’s airway via the outlet funnel and wherein a ratio of (a) a diameter of the inlet funnel at a connection with the dispersion chamber and (b) a diameter of the dispersion chamber is between 0.4 and 0.6 to optimize the oscillation of the actuator as taught by Donovan as this would break apart any clumps of medicament powder that might impede delivery to the patient.
In regards to claim 17, Cocozza in view of Haerder, Donovan, Giroux and Ahern teaches the method of claim 15 and Cocozza further teaches that centrifugal forces are generated within the capsule seat (the medicament capsule spins rapidly within the capsule seat upon inhalation) thus fluidizing the powder prior to the air and medicament powder being drawn through the grid (column 5 line 20-37).
In regards to claim 18, Cocozza in view of Haerder, Donovan, Giroux and Ahern teaches the method of claim 15 and Cocozza further teaches that all airflow into the device leaves through the outlet funnel (no other outlet than the mouthpiece 22, Fig 1).
In regards to claim 19, Cocozza in view of Haerder, Donovan, Giroux and Ahern teaches the method of claim 15.
Cocozza does not teach that the diameter of the dispersion chamber is equal to the inlet diameter of the outlet funnel.
However, Donovan teaches that the diameter of the dispersion chamber is equal to the inlet diameter of the outlet funnel (Fig 4C elements 402 and 406).
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 Cocozza such that the diameter of the dispersion chamber is equal to the inlet diameter of the outlet funnel as taught by Donovan as this would ensure that the minimal amount of medicament might be caught against obstructive surfaces.
Claim 16 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cocozza (US Patent No. 3,991,761) in view of Haerder (US Patent No. 9,010,323), Donovan (US Patent Publication No. 2012/0145150), Giroux (US Patent No. 7,905,229) and Ahern (US Patent Publication No. 2018/0043111) as applied to claim 15 above, and in further view of Horlin (US Patent No. 6,230,707).
In regards to claim 16, Cocozza in view of Haerder, Donovan, Giroux and Ahern teaches the method of claim 15.
Cocozza does not teach reducing the turbulent forces and reducing velocity of the deaggregated powder agglomerates in a flow field exiting the inhaler, thereby minimizing particle deposition in the patient’s mouth and throat and ensuring a higher concentration of particles to peripheral regions of the patient’s lungs.
However, Haerder teaches reducing the turbulent forces and reducing velocity of the deaggregated powder agglomerates in a flow field exiting the inhaler, thereby minimizing particle deposition in the patient’s mouth and throat and ensuring a higher concentration of particles to peripheral regions of the patient’s lungs (Fig 1 element 4).
While Haerder does not explicitly teach reducing the turbulent forces and reducing velocity of the deaggregated powder agglomerates in a flow field exiting the inhaler, thereby minimizing particle deposition in the patient’s mouth and throat and ensuring a higher concentration of particles to peripheral regions of the patient’s lungs, Horlin teaches that widening the outlet funnel decrease particle velocity, resulting in better delivery of powder medicament to the lungs (Horlin: column 4 line 48-52). 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 Cocozza to reduce the turbulent forces and reducing velocity of the deaggregated powder agglomerates in a flow field exiting the inhaler, thereby minimizing particle deposition in the patient’s mouth and throat and ensuring a higher concentration of particles to peripheral regions of the patient’s lungs as this ensures efficient delivery of medicament to the patient.
Claim 20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cocozza (US Patent No. 3,991,761) in view of Haerder (US Patent No. 9,010,323), Donovan (US Patent Publication No. 2012/0145150), Giroux (US Patent No. 7,905,229) and Ahern (US Patent Publication No. 2018/0043111) as applied to claim 15 above, and in further view of Zierenberg (US Patent No. 8,022,082).
In regards to claim 20, Cocozza in view of Haerder, Donovan, Giroux and Ahern teaches the method of claim 15.
Cocozza does not teach that the aerosolized medicament comprises particles having an impaction parameter that enables improved delivery to patient airways of less than about 2 mm in internal diameter.
However, Zierenberg teaches that the aerosolized medicament comprises particles having an impaction parameter that enables improved delivery to patient airways of less than about 2 mm in internal diameter (inhaler dispersion methods results in particles with properties sufficient to deliver medicament to the deep lung region, column 1 line 65 – column 2 line 2).
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 Cocozza such that the aerosolized medicament comprises particles having an impaction parameter that enables improved delivery to patient airways of less than about 2 mm in internal diameter as taught by Zierenberg as this greatly increases the effectiveness of the delivered medicament.
Response to Arguments
In regards to the arguments concerning independent claims 1, 10 and 15, these arguments are not persuasive.
In regards to arguments concerning Ahern, Applicant argues that Ahern fails to teach the limitations of the mesh providing a laminar flow. Applicant claims that Ahern teaches not the mesh providing a laminar flow but another structure, the surrounding screen holder. Examiner disagrees. While Ahern does describe the screen holder as providing laminar flow, it also links this to the overall air flow by describing “uniform distribution of airflow in the inner conduit of the mouthpiece” and also establishes via the structure of the screen holder itself that symmetric arrangement of holes through a surface would provide laminar flow (paragraph 31). As the screen holder is in the same plane as the screen and a screen has the described structure of a series of planar symmetrical holes and Ahern describes the resultant combined air flow traveling through both as being uniform it can be understood that the air flow passing through the screen is laminar.
Conclusion
THIS ACTION IS MADE FINAL. 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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/ARIELLE WOLFF/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785