DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed December 23, 2025 has been entered. Claims 1-7, 9-24, and 26-53 remain pending in the application. Claims 8 and 25 were previously cancelled. Applicant’s amendments to the claims have overcome the objections previously set forth in the Non-Final Office Action mailed September 30, 2025.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A 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 1-5, 7, 10-11, 18-22, 24, 27-28, 35-36, 39, and 43-53 are rejected under 35 U.S.C. 103 as being unpatentable over Pic et al. (US 2021/0275157) in view of Milton (USPN 2987221).
Regarding claim 1, Pic discloses a therapeutic powder applicator (delivery system 10) comprising:
a chamber (enclosure 104 of dispensing portion 100) configured to contain a therapeutic powder (agent 102; “The agent may be, for example, a powdered agent, such as a hemostatic agent.” [0021]), wherein at least a distal portion of the chamber includes a porous membrane (filter 120; Figure 2A) comprising a plurality of pores (“A wall of the filter may include a plurality of pores.” [0008]), and wherein the chamber is at least partially formed from the porous membrane such that the porous membrane defines a volume (channel 122) of the chamber and is configured to support the therapeutic powder during operation (Figure 2A; “An inner surface of wall 121 may define a channel 122. Agent 102 may be at least partially received within channel 122. Surfaces of wall 121 and surfaces of housing 106 may serve to form boundaries for agent 102.” [0026]);
a first pressurized gas source (at fluid inlet 112; “An inlet may be in fluid communication with the enclosure for receiving a flow of pressurized gas” [0012]; “Although fluid inlet 112 is shown at a side portion of housing 106, it will be appreciated that fluid inlet 112 may be in alternative locations. For example, fluid inlet 112 may be…in lid 108.” [0025]) in fluid communication with the chamber through the plurality of pores of the distal portion of the chamber (“A wall of the filter may include a plurality of tortuously-extending pores. The pores may be configured such that the gas is permitted to pass through the pores into a channel defined by a surface of the wall.” [0012]); and
an outlet (outlet 114 and outlet 34; “A catheter or other type of tubing 116 may define outlet 114, as described in further detail below. Outlet 114 may be in fluid communication with outlet 34 of delivery system 10.” [0025]) in fluid communication with the chamber (“The turbulent flow of fluid (which may result in fluidization, such as a liquid sand effect, of agent 102) may aid in a flow of agent 102 through outlet 114” [0030]; Figure 2A), wherein the distal portion of the chamber is located adjacent to the outlet (Figure 2A),
wherein the first pressurized gas source and the chamber are configured such that a first flow of gas from the first pressurized gas source (“The fluid from inlet 112 may also pass through sintered portions of wall 121 into proximal portion 142 of channel 122.” [0038]) flows around at least a portion of the chamber before entering the plurality of pores of the distal portion of the chamber to entrain the therapeutic powder in the first flow of gas (Figure 2A showing the gas flowing around the outside of channel 122; “Fluid from fluid inlet 112 may be permitted to flow through the openings in wall 121” [0029]; “The fluid flowing into channel 122 (e.g., into proximal portion 142) may fluidize agent 102. [0039]), wherein the first flow of gas flows from the proximal portion of the chamber (“Although fluid inlet 112 is shown at a side portion of housing 106, it will be appreciated that fluid inlet 112 may be in alternative locations. For example, fluid inlet 112 may be…in lid 108.” [0025], wherein if the fluid inlet 112 is in lid 108, the first flow of gas flows from the proximal portion of the chamber), and wherein the therapeutic powder applicator is configured to be a handheld applicator (Figure 1) and the outlet is configured to deliver the therapeutic powder to a target area of a subject (“During an endoscopic procedure, a user inserts a sheath of an endoscope into a body lumen of a patient. The user utilizes a handle of the endoscope to control the endoscope during the procedure. Tools are passed through a working channel of the endoscope via, for example, a port in the handle, to deliver treatment at the procedure site near a distal end of the endoscope. The procedure site is remote from the operator…To achieve hemostasis at the remote site, a hemostatic agent may be delivered by a device inserted into the working channel of the endoscope.” [0004-0005]; “an agent (e.g., a powdered agent) and metering/actuation mechanisms to deliver the agent to a site of a medical procedure.” [0020]).
Pic fails to explicitly disclose the first flow of gas from the first pressurized gas source flows around at least a proximal portion of the chamber before entering the plurality of pores of the distal portion of the chamber.
Milton teaches a therapeutic powder applicator (Figure 2) comprising a chamber (axial passageway 22 and annular cavity 42 of main body 20); a first pressurized gas source (fitting 28; “a second passageway 26 through the main body which is laterally disposed from the axial passageway and connects with a fitting 28 which is internally connected to a source of conveying gas” [Col 2, lines 45-49]) in fluid communication with the chamber (Figure 2); an outlet (conveying means 18) in fluid communication with the chamber (Figure 2); wherein the first pressurized gas source and chamber are configured such that a first flow of gas from the first pressurized gas source (through second passageway 26) flows around at least a proximal portion of the chamber (axial passageway 22) before entraining the therapeutic powder (Figure 2, showing the gas flows through the passageway 26, around the axial passageway 22 before entering the annular cavity 42 to entrain the powder).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the first flow of gas from the first pressurized gas source of the therapeutic powder applicator of Pic to flow around at least a proximal portion of the chamber before entering the plurality of pores of the distal portion of the chamber based on the teachings of Milton to guide the first flow of gas directly to the therapeutic powder supported by the porous membrane (Milton [Col 3, lines 45-67]; Figure 2).
Regarding claim 2, modified Pic discloses the therapeutic powder applicator of claim 1, further comprising the therapeutic powder (agent 102) disposed in the chamber (Figure 2A).
Regarding claim 3, modified Pic discloses the therapeutic powder applicator of claim 2, wherein the therapeutic powder (agent 102) is a hemostatic powder (“The agent may be, for example, a powdered agent, such as a hemostatic agent.” [0021]).
Regarding claim 4, modified Pic discloses the therapeutic powder applicator of claim 1, wherein the pressurized gas source and the chamber are configured such that the entrained therapeutic powder flows through the outlet (“The tortuous passages of wall 121 may cause fluid flowing through filter 120 to enter channel 122 at a wide variety of vectors, including angles, velocities, and/or pressures at the same time. The fluid exiting wall 121 may have a turbulent flow pattern (e.g., a radial pattern). As also described below, the varying vectors with which fluid enters channel 122 may cause agent 102 within channel 122 to become fluidized. The turbulent flow of fluid (which may result in fluidization, such as a liquid sand effect, of agent 102) may aid in a flow of agent 102 through outlet 114” [0030]; Figure 2A).
Regarding claim 5, modified Pic discloses the therapeutic powder applicator of claim 4, wherein the first pressurized gas source and the outlet are configured such that a second flow of gas (“The fluid from fluid inlet 112 may pass through sintered portions of wall 121 of distal portion 144 of filter 120.” [0038]) from the first pressurized gas source flows through the outlet without flowing through the chamber (Figure 2A showing a gas flow through the distal portion 144 of filter 120 to outlet 114 without flowing through enclosure 104).
Regarding claim 7, modified Pic discloses the therapeutic powder applicator of claim 4.
Modified Pic fails to explicitly teach a second pressurized gas source, wherein the second pressurized gas source and the outlet are configured such that a second flow of gas from the second pressurized gas source flows through the outlet without flowing through the chamber.
Milton teaches a therapeutic powder applicator (Figure 2) comprising a chamber (main body member 20); a first pressurized gas source (fitting 28; “a second passageway 26 through the main body which is laterally disposed from the axial passageway and connects with a fitting 28 which is internally connected to a source of conveying gas” [Col 2, lines 45-49]) in fluid communication with the chamber (Figure 2); an outlet (conveying means 18) in fluid communication with the chamber (Figure 2); and a second pressurized gas source (secondary conveying gas source 50), wherein the second pressurized gas source and the outlet are configured such that a second flow of gas (through tube 48) from the second pressurized gas source flows through the outlet without flowing through the chamber (“There is also provided in this third body member a tube 48 which is connected to the secondary conveying gas source 50 and which is disposed with its inner end downwardly directed to direct the secondary gas flow along the axis of the bore of said third body member.” [Col 3, lines 33-38]; Figure 2 showing that the second flow of gas is directed downward away from the main body member 2).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the therapeutic powder applicator of Pic to include a second pressurized gas source to deliver a second flow of gas that flows through the outlet without flowing through the chamber based on the teachings of Milton to increase the velocity of the entrained powder at the outlet and prevent clogging the outlet (Milton [Col 3, line 72 – Col 4, line 11]).
Regarding claim 10, modified Pic discloses the therapeutic powder applicator of claim 1, wherein a longitudinal axis of the chamber (axis through enclosure 104) is parallel with an axis passing through the outlet (axis through outlet 114; Figure 2A showing the chamber and outlet 114 are coaxial).
Regarding claim 11, modified Pic discloses the therapeutic powder applicator of claim 1, wherein a longitudinal axis of the chamber (axis through enclosure 104) is angled relative to an axis passing through the outlet (axis along outlet 34; “A catheter or other type of tubing 116 may define outlet 114, as described in further detail below. Outlet 114 may be in fluid communication with outlet 34 of delivery system 10.” [0025]; Figure 1 showing the two axes angled relative to each other).
Regarding claim 18, Pic discloses a therapeutic powder applicator (delivery system 10) comprising:
a chamber (enclosure 104 of dispensing portion 100) configured to contain a therapeutic powder (agent 102; “The agent may be, for example, a powdered agent, such as a hemostatic agent.” [0021]), wherein at least a distal portion of the chamber includes a porous membrane (filter 120; Figure 2A) comprising a plurality of pores (“A wall of the filter may include a plurality of pores.” [0008]), and wherein the chamber is at least partially formed from the porous membrane such that the porous membrane defines a volume (channel 122) of the chamber and is configured to support the therapeutic powder during operation (Figure 2A; “An inner surface of wall 121 may define a channel 122. Agent 102 may be at least partially received within channel 122. Surfaces of wall 121 and surfaces of housing 106 may serve to form boundaries for agent 102.” [0026]);
a first gas inlet (fluid inlet 112; “An inlet may be in fluid communication with the enclosure for receiving a flow of pressurized gas” [0012]); and
an outlet (outlet 114 and outlet 34; “A catheter or other type of tubing 116 may define outlet 114, as described in further detail below. Outlet 114 may be in fluid communication with outlet 34 of delivery system 10.” [0025]) in fluid communication with the chamber (“The turbulent flow of fluid (which may result in fluidization, such as a liquid sand effect, of agent 102) may aid in a flow of agent 102 through outlet 114” [0030]; Figure 2A), wherein the first gas inlet (fluid inlet 112) is in fluid communication with the outlet through the plurality of pores of the distal portion of the chamber (“The fluid from fluid inlet 112 may pass through sintered portions of wall 121 of distal portion 144 of filter 120. The fluid may flow into channel 122, into catheter 116, and out of outlet 114. The fluid from inlet 112 may also pass through sintered portions of wall 121 into proximal portion 142 of channel 122.” [0038]), wherein the distal portion of the chamber is located adjacent to the outlet (Figure 2A),wherein the first gas inlet and the chamber are configured such that a first flow of gas from the first gas inlet (“The fluid from inlet 112 may also pass through sintered portions of wall 121 into proximal portion 142 of channel 122.” [0038]) flows around at least a portion of the chamber before entering the plurality of pores of the distal portion of the chamber to entrain the therapeutic powder in the first flow of gas (Figure 2A showing the gas flowing around the outside of channel 122; “Fluid from fluid inlet 112 may be permitted to flow through the openings in wall 121” [0029]; “The fluid flowing into channel 122 (e.g., into proximal portion 142) may fluidize agent 102. [0039]), wherein the first flow of gas flows from the proximal portion of the chamber (“Although fluid inlet 112 is shown at a side portion of housing 106, it will be appreciated that fluid inlet 112 may be in alternative locations. For example, fluid inlet 112 may be…in lid 108.” [0025], wherein if the fluid inlet 112 is in lid 108, the first flow of gas flows from the proximal portion of the chamber), and wherein the therapeutic powder applicator is configured to be a handheld applicator (Figure 1) and the outlet is configured to deliver the therapeutic powder to a target area of a subject (“During an endoscopic procedure, a user inserts a sheath of an endoscope into a body lumen of a patient. The user utilizes a handle of the endoscope to control the endoscope during the procedure. Tools are passed through a working channel of the endoscope via, for example, a port in the handle, to deliver treatment at the procedure site near a distal end of the endoscope. The procedure site is remote from the operator…To achieve hemostasis at the remote site, a hemostatic agent may be delivered by a device inserted into the working channel of the endoscope.” [0004-0005]; “an agent (e.g., a powdered agent) and metering/actuation mechanisms to deliver the agent to a site of a medical procedure.” [0020]).
Pic fails to explicitly disclose the first flow of gas from the first gas inlet flows around at least a proximal portion of the chamber before entering the plurality of pores of the distal portion of the chamber.
Milton teaches a therapeutic powder applicator (Figure 2) comprising a chamber (axial passageway 22 and annular cavity 42 of main body 20); a first gas inlet (fitting 28; “a second passageway 26 through the main body which is laterally disposed from the axial passageway and connects with a fitting 28 which is internally connected to a source of conveying gas” [Col 2, lines 45-49]); an outlet (conveying means 18) in fluid communication with the chamber (Figure 2); wherein the first gas inlet and chamber are configured such that a first flow of gas from the first gas inlet (through second passageway 26) flows around at least a proximal portion of the chamber (axial passageway 22) before entraining the therapeutic powder (Figure 2, showing the gas flows through the passageway 26, around the axial passageway 22 before entering the annular cavity 42 to entrain the powder).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the first flow of gas from the first gas inlet of the therapeutic powder applicator of Pic to flow around at least a proximal portion of the chamber before entering the plurality of pores of the distal portion of the chamber based on the teachings of Milton to guide the first flow of gas directly to the therapeutic powder supported by the porous membrane (Milton [Col 3, lines 45-67]; Figure 2).
Regarding claim 19, modified Pic discloses the therapeutic powder applicator of claim 18, further comprising the therapeutic powder (agent 102) disposed in the chamber (Figure 2A).
Regarding claim 20, modified Pic discloses the therapeutic powder applicator of claim 19, wherein the therapeutic powder (agent 102) is a hemostatic powder “The agent may be, for example, a powdered agent, such as a hemostatic agent.” [0021]).
Regarding claim 21, modified Pic discloses the therapeutic powder applicator of claim 18, further comprising a first conduit (protrusion 111) extending between the first gas inlet and the chamber (Figure 2C).
Regarding claim 22, modified Pic discloses the therapeutic powder applicator of claim 21, further comprising a second conduit (through distal portion 144) extending between the first gas inlet and the outlet (outlet 144) such that a second flow of gas flows through the outlet without flowing through the chamber (Figure 2A showing a gas flow through the distal portion 144 of filter 120 to outlet 114 without flowing through enclosure 104).
Regarding claim 24, modified Pic discloses the therapeutic powder applicator of claim 21.
Modified Pic fails to explicitly teach a second gas inlet, wherein the second gas inlet and the outlet are in fluid communication such that a second flow of gas from the second gas inlet flows through the outlet without flowing through the chamber.
Milton teaches a therapeutic powder applicator (Figure 2) comprising a chamber (main body member 20); a first gas inlet (fitting 28; “a second passageway 26 through the main body which is laterally disposed from the axial passageway and connects with a fitting 28 which is internally connected to a source of conveying gas” [Col 2, lines 45-49]); an outlet (conveying means 18) in fluid communication with the chamber (Figure 2); and a second gas inlet (tube 48), wherein the second gas inlet and the outlet (conveying hose 18) are in fluid communication such that a second flow of gas from the second gas inlet flows through the outlet without flowing through the chamber (“There is also provided in this third body member a tube 48 which is connected to the secondary conveying gas source 50 and which is disposed with its inner end downwardly directed to direct the secondary gas flow along the axis of the bore of said third body member.” [Col 3, lines 33-38]; Figure 2 showing that the second flow of gas is directed downward away from the main body member 2).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the therapeutic powder applicator of Pic to include a second gas inlet in fluid communication with the outlet such that a second flow of gas from the second gas inlet flows through the outlet without flowing through the chamber based on the teachings of Milton to increase the velocity of the entrained powder at the outlet and prevent clogging the outlet (Milton [Col 3, line 72 – Col 4, line 11]).
Regarding claim 27, modified Pic discloses the therapeutic powder applicator of claim 18, wherein a longitudinal axis of the chamber (axis through enclosure 104) is parallel with an axis passing through the outlet (axis through outlet 114; Figure 2A showing the chamber and outlet 114 are coaxial).
Regarding claim 28, modified Pic discloses the therapeutic powder applicator of claim 18, wherein a longitudinal axis of the chamber (axis through enclosure 104) is angled relative to an axis passing through the outlet (axis along outlet 34; “A catheter or other type of tubing 116 may define outlet 114, as described in further detail below. Outlet 114 may be in fluid communication with outlet 34 of delivery system 10.” [0025]; Figure 1 showing the two axes angled relative to each other).
Regarding claim 35, Pic discloses a method of applying a therapeutic powder (“Various aspects of the present disclosure relate generally to devices and methods for delivering agents” [0002]; “The agent may be, for example, a powdered agent, such as a hemostatic agent.” [0021]), the method comprising:
flowing a first gas flow (“The fluid from inlet 112 may also pass through sintered portions of wall 121 into proximal portion 142 of channel 122.” [0038]) around at least a portion (outside of proximal portion 142) of a chamber (enclosure 104) before flowing the first gas flow through a plurality of pores (“A wall of the filter may include a plurality of pores.” [0008]) of a porous membrane (filter 120) disposed at a distal portion of the chamber containing the therapeutic powder (Figure 2A showing the gas flowing around the outside of channel 122; “The fluid from inlet 112 may also pass through sintered portions of wall 121 into proximal portion 142 of channel 122.” [0038]), wherein the first gas flows from the proximal portion of the chamber (“Although fluid inlet 112 is shown at a side portion of housing 106, it will be appreciated that fluid inlet 112 may be in alternative locations. For example, fluid inlet 112 may be…in lid 108.” [0025], wherein if the fluid inlet 112 is in lid 108, the first flow of gas flows from the proximal portion of the chamber), wherein the chamber is at least partially formed from the porous membrane such that the porous membrane defines a volume (channel 122) of the chamber and is configured to support the therapeutic powder during operation (Figure 2A; “An inner surface of wall 121 may define a channel 122. Agent 102 may be at least partially received within channel 122. Surfaces of wall 121 and surfaces of housing 106 may serve to form boundaries for agent 102.” [0026]);
entraining the therapeutic powder in the first gas flow (Figure 2A; “Fluid from fluid inlet 112 may be permitted to flow through the openings in wall 121” [0029]; “The fluid flowing into channel 122 (e.g., into proximal portion 142) may fluidize agent 102. [0039]);
flowing the entrained therapeutic powder through an outlet (outlet 114) in fluid communication with the chamber (“The turbulent flow of fluid (which may result in fluidization, such as a liquid sand effect, of agent 102) may aid in a flow of agent 102 through outlet 114” [0030]; Figure 2A), wherein the distal portion of the chamber is located adjacent to the outlet (Figure 2A); and
delivering the therapeutic powder from the outlet to a target area of a subject (Figure 1; “a hemostatic agent may be delivered by a device inserted into the working channel of the endoscope.” [0005]; “an agent (e.g., a powdered agent) and metering/actuation mechanisms to deliver the agent to a site of a medical procedure.” [0020]).
Pic fails to explicitly disclose flowing the first gas flow around at least the proximal portion of the chamber before flowing the first gas flow through the plurality of pores.
Milton teaches a method of applying a therapeutic powder ([Col 3, lines 45-67]), the method comprising: flowing a first gas flow (“Gas distributor 32 is provided with a plurality of downwardly directed openings 34 through which the conveying gas is ejected.” [Col 2, lines 63-65]; Figure 2) around at least a proximal portion (axial passageway 22) of a chamber (axial passageway 22 and annular cavity 42 of main body 20) before flowing the first gas flow through a plurality of pores (openings 34) of a porous membrane (gas distributor 32) disposed at a distal portion of the chamber containing the therapeutic powder (“powder flows through the axial passageway 22 in the main body member 20 and metering nozzle 30 both under gravity and whatever gas pressure, if any, may be present in the hopper. The powder falls upon the metering shelf 24 and forms an essentially conical pile between the metering shelf and the lower end of the metering nozzle” [Col 3, lines 45-51]; Figure 2, showing the gas flows through the passageway 26, around the axial passageway 22 before entering the annular cavity 42 to entrain the powder).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method of Pic to include flowing the first gas flow around at least the proximal portion of the chamber before flowing the first gas flow through the plurality of pores based on the teachings of Milton to guide the first flow of gas directly to the therapeutic powder supported by the porous membrane (Milton [Col 3, lines 45-67]; Figure 2).
Regarding claim 36, modified Pic discloses the method of claim 35, further comprising flowing a second flow of gas (“The fluid from fluid inlet 112 may pass through sintered portions of wall 121 of distal portion 144 of filter 120.” [0038]) through the outlet (outlet 114) without flowing through the plurality of pores of the chamber (Figure 2A showing a gas flow through the distal portion 144 of filter 120 to outlet 114 without flowing through enclosure 104).
Regarding claim 39, modified Pic discloses the method of claim 36.
Modified Pic fails to explicitly disclose further comprising supplying the first gas flow from a first pressurized gas source, and supplying the second gas flow from a second pressurized gas source.
Milton teaches a method of applying a therapeutic powder ([Col 3, lines 45-67]), the method comprising: flowing a first gas flow (“Gas distributor 32 is provided with a plurality of downwardly directed openings 34 through which the conveying gas is ejected.” [Col 2, lines 63-65]; Figure 2) around at least a proximal portion of a chamber (main body member 20 and second body member 36) before flowing the first gas flow through a plurality of pores (openings 34) of a porous membrane (gas distributor 32) disposed at a distal portion of the chamber containing the therapeutic powder (“powder flows through the axial passageway 22 in the main body member 20 and metering nozzle 30 both under gravity and whatever gas pressure, if any, may be present in the hopper. The powder falls upon the metering shelf 24 and forms an essentially conical pile between the metering shelf and the lower end of the metering nozzle” [Col 3, lines 45-51]); entraining the therapeutic powder in the first gas flow (“The main conveying gas stream passes through the openings 34 in the annular gas distributor 32 which surrounds the metering nozzle 39 above the lower end thereof and forms a substantially tubular or annular stream which passes down over the edges of the conical pile of powder and through the openings 44 in the metering shelf 24. This annular gas stream entrains powder from the exposed lower edges of the conical pile and due to the relatively -thin wall section of the gas stream and to the continuous contact said stream makes with the pile of powder around the entire periphery thereof an extremely uniform amount of powder is entrained in the gas stream for any given velocity of conveying gas.” [Col 3, lines 45-63]); and flowing the entrained therapeutic powder through an outlet (conveying means 18) in fluid communication with the chamber (Figure 2; “The gas entrained powder is directed into the suitable conduit means 18 by means of the funnel shaped upper part of the third body member 46 located below the metering shelf 24.” [Col 4, lines 64-67]); further comprising flowing a second gas flow (through tube 48) through the outlet (conveying means 18) without flowing through the plurality of pores of the chamber (“There is also provided in this third body member a tube 48 which is connected to the secondary conveying gas source 50 and which is disposed with its inner end downwardly directed to direct the secondary gas flow along the axis of the bore of said third body member.” [Col 3, lines 33-38]; Figure 2 showing that the second flow of gas is directed downward away from the main body member 2); and further comprising supplying the first gas flow from a first pressurized gas source (“a second passageway 26 through the main body which is laterally disposed from the axial passageway and connects with a fitting 28 which is internally connected to a source of conveying gas” [Col 2, lines 45-49]), and supplying the second gas flow from a second pressurized gas source (secondary conveying gas source 50; Figure 2).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of Pic to include supplying the first gas flow from a first pressurized gas source, and supplying the second gas flow from a second pressurized gas source based on the teachings of Milton to increase the velocity of the entrained powder at the outlet and prevent clogging the outlet (Milton [Col 3, line 72 – Col 4, line 11]).
Regarding claim 43, modified Pic discloses the therapeutic powder applicator of claim 1, further comprising a first gas inlet (fluid inlet 112) in fluid communication with the outlet through the plurality of pores of the distal portion of the chamber (“fluid may be permitted to flow through fluid inlet 112 (see FIGS. 2C-2E). The fluid from fluid inlet 112 may pass through sintered portions of wall 121 of distal portion 144 of filter 120. The fluid may flow into channel 122, into catheter 116, and out of outlet 114.” [0038]), wherein the first gas inlet is located adjacent to the proximal portion (lid 108) of the chamber (“A wall of housing 106 may form a protrusion 111, which may define fluid inlet 112…Although fluid inlet 112 is shown at a side portion of housing 106, it will be appreciated that fluid inlet 112 may be in alternative locations. For example, fluid inlet 112 may be…in lid 108.” [0025]).
Regarding claim 44, modified Pic discloses the therapeutic powder applicator of claim 1, wherein the outlet (outlet 114) is configured to be oriented at least partially vertically downwards during operation of the applicator such that the therapeutic powder is positioned adjacent to the distal portion of the chamber (Figures 2A-2E).
Regarding claim 45, modified Pic discloses the therapeutic powder applicator of claim 18, wherein the first gas inlet (fluid inlet 112) is located adjacent to the proximal portion (lid 108) of the chamber (“A wall of housing 106 may form a protrusion 111, which may define fluid inlet 112…Although fluid inlet 112 is shown at a side portion of housing 106, it will be appreciated that fluid inlet 112 may be in alternative locations. For example, fluid inlet 112 may be…in lid 108.” [0025]).
Regarding claim 46, modified Pic discloses the therapeutic powder applicator of claim 18, wherein the outlet (outlet 114) is configured to be oriented at least partially vertically downwards during operation of the applicator such that the therapeutic powder is positioned adjacent to the distal portion of the chamber (Figures 2A-2E).
Regarding claim 47, modified Pic discloses the therapeutic powder applicator of claim 1, wherein the porous membrane (filter 120) is constructed out of a woven material or a non-woven material (“The enclosure may include a sintered filter through which a pressurized fluid may pass.” [0020]; see detailed [0029] and [0081]).
Regarding claim 48, modified Pic discloses the therapeutic powder applicator of claim 1, wherein the porous membrane (filter 120) is located adjacent to the outlet (outlet 114; Figure 2A).
Regarding claim 49, modified Pic discloses the therapeutic powder applicator of claim 18, wherein the porous membrane (filter 120) is constructed out of a woven material or a non-woven material (“The enclosure may include a sintered filter through which a pressurized fluid may pass.” [0020]; see detailed [0029] and [0081]).
Regarding claim 50, modified Pic discloses the therapeutic powder applicator of claim 18, wherein the porous membrane (filter 120) is located adjacent to the outlet (outlet 114; Figure 2A).
Regarding claim 51, modified Pic discloses the therapeutic powder applicator of claim 1, wherein the proximal portion of the chamber (lid 108) is non-porous (Figure 2A showing that flow of gas does not pass through lid 108).
Regarding claim 52, modified Pic discloses the therapeutic powder applicator of claim 18, wherein the proximal portion of the chamber (lid 108) is non-porous (Figure 2A showing that flow of gas does not pass through lid 108).
Regarding claim 53, modified Pic discloses the therapeutic powder applicator of claim 1.
Modified Pic fails to explicitly disclose one or more channels located between an exterior surface of the chamber and an interior surface of a housing of the applicator, wherein the first flow of gas from the first pressurized gas source flows through the one or more channels before entering the plurality of pores of the distal portion of the chamber.
Milton teaches a therapeutic powder applicator (Figure 2) comprising a chamber (axial passageway 22 and annular cavity 42 of main body 20); a first pressurized gas source (fitting 28; “a second passageway 26 through the main body which is laterally disposed from the axial passageway and connects with a fitting 28 which is internally connected to a source of conveying gas” [Col 2, lines 45-49]) in fluid communication with the chamber (Figure 2); and outlet (conveying means 18) in fluid communication with the chamber (Figure 2); further comprising one or more channels (second passageway 26 and gas distributer 32) located between an exterior surface of the chamber (outer surface of metering nozzle 30, for example) and an interior surface of a housing of the applicator (second body member 36; Figure 2 showing at least gas distributer 32 located between metering nozzle 30 and second body member 36), wherein the first flow of gas from the first pressurized gas source flows through the one or more channels before entering the distal portion of the chamber (Figure 2; “The main conveying gas stream passes through the openings 34 in the annular gas distributor 32 which surrounds the metering nozzle 30 above the lower end thereof and forms a substantially tubular or annular stream which passes down over the edges of the conical pile of powder and through the openings 44 in the metering shelf 24.” [Col 3, lines 51-56]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the therapeutic powder applicator of Pic to include one or more channels located between an exterior surface of the chamber and an interior surface of a housing of the applicator, wherein the first flow of gas from the first pressurized gas source flows through the one or more channels before entering the plurality of pores of the distal portion of the chamber based on the teachings of Milton to guide the first flow of gas directly to the therapeutic powder supported by the porous membrane (Milton [Col 3, lines 45-67]; Figure 2).
Claims 6, 23, and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Pic et al. (US 2021/0275157) in view of Milton (USPN 2987221) as applied in claims 5, 22, and 36 above, and further in view of Ahn et al. (USPN 5816509).
Regarding claim 6, modified Pic discloses the therapeutic powder applicator of claim 5.
Modified Pic fails to explicitly disclose wherein a relative flow rate of the first flow of gas and the second flow of gas is adjustable.
Ahn teaches a therapeutic powder applicator (Figure 1; “an apparatus for continuously supplying fine particles in minute and quantitative amounts” [Col 1, lines 52-53]), comprising: a chamber (powder storage container 10 including powder suction tube 9 and powder carrying tube 7) configured to contain a therapeutic powder (powder 11), wherein at least a distal portion of the chamber includes a porous membrane (powder suction tube 9); a first pressurized gas source (compressed gas 1) in fluid communication with the chamber through the plurality of pores of the distal portion of the chamber (“a compressed gas enters into the powder container from a compressed gas injecting channel 8 of the upper portion of the powder container through the fluidizing holes 16 of the powder suction tube at a fast velocity.” [Col 2, line 67 – Col 3, line 4]; Figures 1 and 2b); and an outlet (orifice through 5 and powder injection channel 6) in fluid communication with the chamber (Figure 1), wherein the first pressurized gas source and the chamber are configured such that a first flow of gas (through gas injecting channel 8) from the first pressurized gas source flows around at least a portion of the chamber before entering the plurality of pores of the distal portion of the chamber to entrain the therapeutic powder in the first flow of gas (Figures 1 and 2b; “a compressed gas enters into the powder container from a compressed gas injecting channel 8 of the upper portion of the powder container through the fluidizing holes 16 of the powder suction tube at a fast velocity… the compressed air fluidizes the powder 11 down to a certain depth under the surface, i.e., to a fluidizing region 17. Therefore, the powder and the air are mixed together into an aerosol 19, and flow through a powder injecting channel 6 of FIG. 1.” [Col 2, line 67 – Col 3, line 9], wherein compressed gas flows around the powder carrying tube 7 and the powder suction tube 9 as shown by arrows 18 in Figure 2b); and wherein the first pressurized gas source (compressed gas 1) and the outlet (orifice throat 5 and powder injecting channel 6) are configured such that a second flow of gas (through gas spouting nozzle 4) from the first pressurized gas source flows through the outlet without flowing through the chamber (Figure 1; wherein gas through nozzle 4 flows from the gas source to the powder injection channel 6 without entering the powder storage container 10); and wherein a relative flow rate of the first flow of gas and the second flow of gas is adjustable (“a compressed gas 1 consisting of air, N2, Ar or CO2 is spouted through a flow rate adjusting valve 2” [Col 2, lines 38-40]; Figure 2).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the therapeutic powder applicator of Pic to include a relative flow rate of the first flow of gas and the second flow of gas is adjustable based on the teachings of Ahn to allow for accurate adjustment of the flow of the entrained therapeutic powder to provide a continuous dispersed supply of the therapeutic powder (Ahn [Col 2, lines 9-16]).
Regarding claim 23, modified Pic discloses the therapeutic powder applicator of claim 22.
Modified Pic fails to explicitly disclose a variable flow resistance disposed along the first and/or second conduit.
Ahn discloses a therapeutic powder applicator (Figure 1) comprising: a chamber (powder storage container 10) configured to contain a therapeutic powder (powder 11), wherein at least a distal portion of the chamber includes a porous membrane (powder suction tube 9; Figures 2a-2b); a first gas inlet (lower branch from compressed gas 1 in Figure 1 extending towards gas injecting channel 8); and an outlet (orifice throat 5 and powder injection channel 6) in fluid communication with the chamber (Figure 1), wherein the first gas inlet and the chamber are configured such that a first flow of gas (flow through gas injecting channel 8) from the first gas inlet flows around at least a portion of the chamber before entering the plurality of pores of the distal portion of the chamber to entrain the therapeutic powder in the first flow of gas (Figures 1 and 2b; [Col 2, line 67 – Col 3, line 9]); further comprising a first conduit (gas injecting channel 8) extending between the first gas inlet (and the chamber (Figure 1); and a second conduit (nozzle 4; “a compressed gas 1 consisting of air, N2, Ar or CO2 is spouted through a flow rate adjusting valve 2 and a flow meter 3 into a nozzle 4” [Col 2, lines 38-40]) extending between the first gas inlet and the outlet (Figure 1) such that a second flow of gas (flow through nozzle 4) flows through the outlet without flowing through the chamber (Figure 1; wherein gas through nozzle 4 flows from the gas source to the powder injection channel 6 without entering the powder storage container 10); and further comprising a variable flow resistance (flow rate adjusting valve 2) disposed along the first and/or second conduit (Figure 1).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the therapeutic powder applicator of Pic to include a variable flow resistance disposed along the first and/or second conduit based on the teachings of Ahn to allow for accurate adjustment of the flow of the entrained therapeutic powder to provide a continuous dispersed supply of the therapeutic powder (Ahn [Col 2, lines 9-16]).
Regarding claims 37-38, modified Pic discloses the method of claim 36.
Modified Pic fails to explicitly disclose adjusting a relative flow rate of the first gas flow and the second gas flow, as required by claim 37; and further comprising adjusting a spread of the therapeutic powder as the therapeutic powder is dispensed from the outlet, as required by claim 38.
Ahn teaches a method of applying a therapeutic powder (Figure 1; “an apparatus for continuously supplying fine particles in minute and quantitative amounts” [Col 1, lines 52-53]), the method comprising: flowing a first gas flow (through gas injecting channel 8) around at least a portion of a chamber (powder storage container 10) before flowing the first gas flow through a plurality of pores (fluidizing holds 16) of a distal portion of the chamber containing the therapeutic powder (Figures 1 and 2b; “a compressed gas enters into the powder container from a compressed gas injecting channel 8 of the upper portion of the powder container through the fluidizing holes 16 of the powder suction tube at a fast velocity” [Col 2, line 67 – Col 3, line 4]); entraining the therapeutic powder in the first gas flow (“the compressed air fluidizes the powder 11 down to a certain depth under the surface, i.e., to a fluidizing region 17. Therefore, the powder and the air are mixed together into an aerosol 19” [Col 3, lines 5-8]); and further comprising flowing a second gas flow (through gas spouting nozzle 4) through the outlet without flowing through the plurality of pores of the chamber (Figure 1, wherein gas through nozzle 4 flows from the gas source to the powder injection channel 6 without entering the powder storage container 10); further comprising adjusting a relative flow rate of the first gas flow and the second gas flow (via flow rate adjusting valves 2 in Figure 1; “The fluidizing region of the powder can be controlled by adjusting the flow rate of the compressed air which enters into the orifice” [Col 2, lines 9-11]); and adjusting a spread of the therapeutic powder as the therapeutic powder is dispensed from an outlet (“The fluidizing region of the powder can be controlled by adjusting the flow rate of the compressed air which enters into the orifice and the ascending rate of the powder container. Therefore, the powder ascending velocity within the powder container can be controlled, so that the supply of the powder can be accurately adjusted.” [Col 2, lines 9-14]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the method of applying a therapeutic powder of Pic to include adjusting a relative flow rate of the first gas flow and the second gas flow, as required by claim 37; and adjusting a spread of the therapeutic powder as the therapeutic powder is dispensed from the outlet as required by claim 38 based on the teachings of Ahn to allow for accurate adjustment of the flow of the entrained therapeutic powder to provide a continuous dispersed supply of the therapeutic powder (Ahn [Col 2, lines 9-16]).
Claims 9, 16-17, 26, 33-34, and 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over Pic et al. (US 2021/0275157) in view of Milton (USPN 2987221) as applied in claims 1, 18, and 35 above, and further in view of Knoepfler (USPN 5273531).
Regarding claim 9, modified Pic discloses the therapeutic powder applicator of claim 1.
Modified Pic fails to explicitly disclose the first pressurized gas source is a bellows.
Knoepfler teaches a therapeutic powder applicator (powder dispenser 10) comprising a chamber (powder chamber 14) containing a therapeutic powder (thrombic powder 11), a first pressurized gas source that is a bellows (bulb 13, wherein “bellows” has been interpreted as an instrument that alternately expands and contracts to expel air); wherein the pressurized gas source entrains the therapeutic powder (“Bulb 13 is squeezed causing air in the bulb to rush in the direction of arrow 37. This in turn causes the flap 29 to raise in the direction of arrow 35 allowing air to continue down the tube through chamber 14, forcing the powder in chamber 14 down through tube 12 onto the operative site. The internal flaring at first end 21 will encourage the entrained powder to expand as it exists the tube and spread evenly over the operative site.” [Col 2, lines 49-56]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the first pressurized gas source of the therapeutic powder applicator of Pic to be a bellows based on the teachings of Knoepfler to allow the pressurized gas source to be manually actuated such that the entrained powder can be quickly and easily applied to the target location (Knoepfler [Col 1, lines 30-33] and [Col 2, lines 49-50]).
Regarding claims 16 and 17, modified Pic in view of Knoepfler teaches the therapeutic powder applicator of claim 9.
Modified Pic fails to explicitly teach further comprising a first one-way valve configured to prevent backflow into the outlet when the bellows expand, as required by claim 16; and a second one-way valve configured to fluidly connect the bellows with an exterior environment when the bellows expand, as required by claim 17
Knoepfler teaches a therapeutic powder applicator (powder dispenser 10) comprising a chamber (powder chamber 14) containing a therapeutic powder (thrombic powder 11), a first pressurized gas source that is a bellows (bulb 13, wherein “bellows” has been interpreted as an instrument that alternately expands and contracts to expel air), further comprising a first one-way valve (one-way valve 16) configured to prevent backflow into the outlet when the bellows expand (“upstream of powder chamber 14 is one-way valve 16. One-way valve 16 is simply a rubber flap 29…At rest, flap 29 will seat on ledge 36 preventing air downstream of valve 16 from flowing back into bulb 13.” [Col 2, lines 32-39]) and a second one-way valve (one-way valve 31) configured to fluidly connect the bellows with an exterior environment when the bellows expand (Figure 1; “Valve 31 at end of bulb 13 allows air to enter bulb 13 and the procedure can be repeated.” [Col 2, lines 57-58]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the therapeutic powder applicator of Pic to include a first one-way valve and a second one-way valve based on the teachings of Knoepfler to downstream air from flowing back into the bellows while also allowing the bulb to reinflate (Knoepfler [Col 2, lines 32-41 and 57-58]).
Regarding claim 26, modified Pic discloses the therapeutic powder applicator of claim 18.
Modified Pic fails to explicitly disclose a bellows in fluid communication with the first gas inlet.
Knoepfler teaches a therapeutic powder applicator (powder dispenser 10) comprising a chamber (powder chamber 14) containing a therapeutic powder (thrombic powder 11), a first gas inlet (tube 12 upstream of power chamber 14), and a bellows (bulb 13, wherein “bellows” has been interpreted as an instrument that alternately expands and contracts to expel air) in fluid communication with the first gas inlet (“Bulb 13 is squeezed causing air in the bulb to rush in the direction of arrow 37. This in turn causes the flap 29 to raise in the direction of arrow 35 allowing air to continue down the tube through chamber 14, forcing the powder in chamber 14 down through tube 12 onto the operative site. The internal flaring at first end 21 will encourage the entrained powder to expand as it exists the tube and spread evenly over the operative site.” [Col 2, lines 49-56]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the therapeutic powder applicator of Pic to include a bellows in fluid communication with the first gas inlet based on the teachings of Knoepfler to provide a pressurized gas source that can be manually actuated such that the entrained powder can be quickly and easily applied to the target location (Knoepfler [Col 1, lines 30-33] and [Col 2, lines 49-50]).
Regarding claims 33 and 34, modified Pic discloses the therapeutic powder applicator of claim 18.
Modified Pic fails to explicitly disclose a bellows coupled to the first gas inlet, further comprising a first one-way valve configured to prevent backflow into the outlet when the bellows expand, as required by claim 33; and a second one- way valve configured to fluidly connect the bellows with an exterior environment when the bellows expand, as required by claim 34.
Knoepfler teaches a therapeutic powder applicator (powder dispenser 10) comprising a chamber (powder chamber 14) containing a therapeutic powder (thrombic powder 11), a first gas inlet (tube 12 upstream of power chamber 14), and a bellows (bulb 13, wherein “bellows” has been interpreted as an instrument that alternately expands and contracts to expel air) coupled to the first gas inlet (“Bulb 13 is squeezed causing air in the bulb to rush in the direction of arrow 37. This in turn causes the flap 29 to raise in the direction of arrow 35 allowing air to continue down the tube through chamber 14, forcing the powder in chamber 14 down through tube 12 onto the operative site. The internal flaring at first end 21 will encourage the entrained powder to expand as it exists the tube and spread evenly over the operative site.” [Col 2, lines 49-56]); further comprising a first one-way valve (one-way valve 16) configured to prevent backflow into the outlet when the bellows expand (“upstream of powder chamber 14 is one-way valve 16. One-way valve 16 is simply a rubber flap 29…At rest, flap 29 will seat on ledge 36 preventing air downstream of valve 16 from flowing back into bulb 13.” [Col 2, lines 32-39]) and a second one-way valve (one-way valve 31) configured to fluidly connect the bellows with an exterior environment when the bellows expand (Figure 1; “Valve 31 at end of bulb 13 allows air to enter bulb 13 and the procedure can be repeated.” [Col 2, lines 57-58]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the therapeutic powder applicator of Pic to include a bellows coupled to the first gas inlet based on the teachings of Knoepfler to provide a pressurized gas source that can be manually actuated such that the entrained powder can be quickly and easily applied to the target location (Knoepfler [Col 1, lines 30-33] and [Col 2, lines 49-50]) and to further modify the therapeutic powder applicator of Pic to include a first one-way valve and a second one-way valve based on the teachings of Knoepfler to downstream air from flowing back into the bellows while also allowing the bulb to reinflate (Knoepfler [Col 2, lines 32-41 and 57-58]).
Regarding claims 40-42, Pic discloses the method of claim 35.
Pic fails to explicitly disclose compressing a bellows to supply the first gas flow, as required by claim 40; wherein compressing the bellows to supply the first gas flow comprises flowing the first gas flow through a first one-way valve configured to prevent backflow into the outlet when the bellows expand, as required by claim 41; and further comprising releasing the bellows to reinflate the bellows by flowing a second gas flow from an exterior environment through a second one- way valve, as required by claim 42.
Knoepfler teaches a method for applying a therapeutic powder (“a method to impel this powder directly on the operative site and to do so quickly and easily in a precisely desired area.” [Col 1, line 31-33]), the method comprising compressing a bellows (bulb 13, wherein “bellows” has been interpreted as an instrument that alternately expands and contracts to expel air) to supply a first gas flow through a chamber (powder chamber 14) containing a therapeutic powder (thrombic powder 11) to entrain the therapeutic powder (“Bulb 13 is squeezed causing air in the bulb to rush in the direction of arrow 37. This in turn causes the flap 29 to raise in the direction of arrow 35 allowing air to continue down the tube through chamber 14, forcing the powder in chamber 14 down through tube 12 onto the operative site. The internal flaring at first end 21 will encourage the entrained powder to expand as it exists the tube and spread evenly over the operative site.” [Col 2, lines 49-56]); wherein compressing the bellows to supply the first gas flow comprises flowing the first gas flow through a first one-way valve (one-way valve 16) configured to prevent backflow into the outlet when the bellows expand (“upstream of powder chamber 14 is one-way valve 16. One-way valve 16 is simply a rubber flap 29…At rest, flap 29 will seat on ledge 36 preventing air downstream of valve 16 from flowing back into bulb 13.” [Col 2, lines 32-39]); and further comprising releasing the bellows to reinflate the bellows by flowing a second gas flow (one-way valve 31) from an exterior environment through a second one- way valve (Figure 1; “Valve 31 at end of bulb 13 allows air to enter bulb 13 and the procedure can be repeated.” [Col 2, lines 57-58]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method of Pic to include a compressing a bellows to supply the first gas flow as required by claim 40 based on the teachings of Knoepfler to provide a pressurized gas source that can be manually actuated such that the entrained powder can be quickly and easily applied to the target location (Knoepfler [Col 1, lines 30-33] and [Col 2, lines 49-50]) and to further modify the method of Pic to include the use of a first one-way valve and a second one-way valve as required by claims 41 and 42 based on the teachings of Knoepfler to downstream air from flowing back into the bellows while also allowing the bulb to reinflate (Knoepfler [Col 2, lines 32-41 and 57-58]).
Claims 12-15 and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Pic et al. (US 2021/0275157) in view of Milton (USPN 2987221) as applied in claims 1 and 18 above, and further in view of Gittard (US 2015/0094649).
Regarding claim 12, modified Pic discloses the therapeutic powder applicator of claim 1.
Modified Pic fails to explicitly disclose a handle configured to rotate relative to the chamber.
Gittard teaches a therapeutic powder applicator (system 20) comprising a chamber (container 30), a pressurized gas source (pressure source 68) in fluid communication with the chamber (Figure 2), and an outlet (outlet port 62); further comprising a handle (housing 22 including actuator 26) configure to rotate relative to the chamber (“the cap 60 may comprise one or more flanges 63 that permit a secure, removable engagement with a complementary internal region of the section 25 of the housing 22. For example, by rotating the container 30, the flange 63 of the cap 60 may lock in place within the section 25.” [0033]; “a user may rotate the actuator 26, which translates into linear motion via a threaded engagement 29 between the actuator 26 and the housing 22, as shown in FIG. 2” [0038]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the therapeutic powder applicator of Pic to include a handle configured to rotate relative to the chamber based on the teachings of Gittard to securely hold and protect the chamber and pressurized gas source in a manner that allows a user to grasp and actuate the therapeutic powder applicator (Gittard [0026]).
Regarding claim 13, modified Pic teaches the therapeutic powder applicator of claim 12.
Modified Pic fails to explicitly teach the handle is configured to rotate about a rotation axis parallel to an axis passing through the outlet.
Gittard teaches a therapeutic powder applicator (system 20) comprising a chamber (container 30), a pressurized gas source (pressure source 68) in fluid communication with the chamber (Figure 2), and an outlet (outlet port 62); further comprising the handle (housing 22 including actuator 26) is configured to rotate about a rotation axis parallel to an axis passing through the outlet (“a user may rotate the actuator 26, which translates into linear motion via a threaded engagement 29 between the actuator 26 and the housing 22, as shown in FIG. 2” [0038]; Figure 2 wherein the axis of rotation of the actuator 26 is parallel to the vertical axis of the outlet port 62).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the therapeutic powder applicator of Pic to include the handle is configured to rotate about a rotation axis parallel to an axis passing through the outlet based on the teachings of Gittard to allow the user to activate the pressurized gas source (Gittard [0038]).
Regarding claim 14, modified Pic teaches the therapeutic powder applicator of claim 12.
Modified Pic fails to explicitly teach the first pressurized gas source is configured to rotate with the handle when the handle rotates relative to the chamber.
Gittard teaches a therapeutic powder applicator (system 20) comprising a chamber (container 30), a pressurized gas source (pressure source 68) in fluid communication with the chamber (Figure 2), and an outlet (outlet port 62); further comprising a handle (housing 22 including actuator 26), wherein the first pressurized gas source is configured to rotate with the handle when the handle rotates relative to the chamber (“the cap 60 may comprise one or more flanges 63 that permit a secure, removable engagement with a complementary internal region of the section 25 of the housing 22. For example, by rotating the container 30, the flange 63 of the cap 60 may lock in place within the section 25.” [0033]; wherein the pressure source 68 is held within the housing 22 which rotates relative to the container 30 as the container 30 is secured ot the housing 22).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the therapeutic powder applicator of Pic to include the first pressurized gas source is configured to rotate with the handle when the handle rotates relative to the chamber based on the teachings of Gittard to securely hold and protect the chamber and pressurized gas source in a manner that allows a user to grasp and actuate the therapeutic powder applicator (Gittard [0026]).
Regarding claim 15, modified Pic teaches the therapeutic powder applicator of claim 12.
Modified Pic fails to explicitly teach the handle is configured to rotate relative to the first pressurized gas source.
Gittard teaches a therapeutic powder applicator (system 20) comprising a chamber (container 30), a pressurized gas source (pressure source 68) in fluid communication with the chamber (Figure 2), and an outlet (outlet port 62); further comprising the handle (housing 22 including actuator 26) configured to rotate relative to the first pressurized gas source (“a user may rotate the actuator 26, which translates into linear motion via a threaded engagement 29 between the actuator 26 and the housing 22, as shown in FIG. 2” [0038]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the therapeutic powder applicator of Pic to include the handle is configured to rotate relative to the first pressurized gas source based on the teachings of Gittard to allow the user to activate the pressurized gas source (Gittard [0038]).
Regarding claim 29, modified Pic discloses the therapeutic powder applicator of claim 18.
Modified Pic fails to explicitly disclose a handle configured to rotate relative to the chamber.
Gittard teaches a therapeutic powder applicator (system 20) comprising a chamber (container 30), a first gas inlet (from pressure source 68), and an outlet (outlet port 62); further comprising a handle (housing 22 including actuator 26) configure to rotate relative to the chamber (“the cap 60 may comprise one or more flanges 63 that permit a secure, removable engagement with a complementary internal region of the section 25 of the housing 22. For example, by rotating the container 30, the flange 63 of the cap 60 may lock in place within the section 25.” [0033]; “a user may rotate the actuator 26, which translates into linear motion via a threaded engagement 29 between the actuator 26 and the housing 22, as shown in FIG. 2” [0038]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the therapeutic powder applicator of Pic to include a handle configured to rotate relative to the chamber based on the teachings of Gittard to securely hold and protect the chamber and pressurized gas source in a manner that allows a user to grasp and actuate the therapeutic powder applicator (Gittard [0026]).
Regarding claim 30, modified Pic teaches the therapeutic powder applicator of claim 29.
Modified Pic fails to explicitly teach the handle is configured to rotate about a rotation axis parallel to an axis passing through the outlet.
Gittard teaches a therapeutic powder applicator (system 20) comprising a chamber (container 30), a first gas inlet (from pressure source 68), and an outlet (outlet port 62); further comprising the handle (housing 22 including actuator 26) is configured to rotate about a rotation axis parallel to an axis passing through the outlet (“a user may rotate the actuator 26, which translates into linear motion via a threaded engagement 29 between the actuator 26 and the housing 22, as shown in FIG. 2” [0038]; Figure 2 wherein the axis of rotation of the actuator 26 is parallel to the vertical axis of the outlet port 62).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the therapeutic powder applicator of Pic to include the handle is configured to rotate about a rotation axis parallel to an axis passing through the outlet based on the teachings of Gittard to allow the user to activate the pressurized gas source (Gittard [0038]).
Regarding claim 31, modified Pic teaches the therapeutic powder applicator of claim 29.
Modified Pic fails to explicitly teach the first gas inlet is configured to rotate with the handle when the handle rotates relative to the chamber.
Gittard teaches a therapeutic powder applicator (system 20) comprising a chamber (container 30) and a first gas inlet (from pressure source 68); further comprising a handle (housing 22 including actuator 26), wherein the first gas inlet is configured to rotate with the handle when the handle rotates relative to the chamber (“the cap 60 may comprise one or more flanges 63 that permit a secure, removable engagement with a complementary internal region of the section 25 of the housing 22. For example, by rotating the container 30, the flange 63 of the cap 60 may lock in place within the section 25.” [0033]; wherein the pressure source 68 is held within the housing 22, and the housing 22 rotates relative to the container 30 as the container 30 is secured ot the housing 22).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the therapeutic powder applicator of Pic to include the first gas inlet is configured to rotate with the handle when the handle rotates relative to the chamber based on the teachings of Gittard to securely hold and protect the chamber and pressurized gas source in a manner that allows a user to grasp and actuate the therapeutic powder applicator (Gittard [0026]).
Regarding claim 32, modified Pic teaches the therapeutic powder applicator of claim 29.
Modified Pic fails to explicitly teach the handle is configured to rotate relative to the first gas inlet.
Gittard teaches a therapeutic powder applicator (system 20) comprising a chamber (container 30) and a first gas inlet (from pressure source 68); further comprising a handle (housing 22 including actuator 26) configured to rotate relative to the first gas inlet (“a user may rotate the actuator 26, which translates into linear motion via a threaded engagement 29 between the actuator 26 and the housing 22, as shown in FIG. 2” [0038]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the therapeutic powder applicator of Pic to include the handle is configured to rotate relative to the first gas inlet based on the teachings of Gittard to allow the user to activate the pressurized gas source (Gittard [0038]).
Response to Arguments
Applicant's arguments filed December 23, 2025 have been fully considered but they are not persuasive.
Regarding the argument that “one of ordinary skill in the art would not have been motivated to modify the arrangement of Pic to have gas flow around the proximal portion of the chamber to pores of the distal portion of the chamber” because “Pic provides motivation for flowing the gas through a fluid inlet in the lid…and directly into the interior of the enclosure 104 to fluidize the powder agent 102, not around the enclosure” (Remarks, pages 12-13), the examiner respectfully disagrees. As detailed in the rejections of the independent claims above, Pic discloses a therapeutic powder applicator except for the limitation “a first flow of gas from the first pressurized gas source flows around at least a proximal portion of the chamber before entering the plurality of pores of the distal portion of the chamber” as required by claim 1 and similarly recited in claims 18 and 35. Pic does disclose that the first flow of gas, from fluid inlet 112, may be located in lid 108, at the proximal end of the chamber (“Although fluid inlet 112 is shown at a side portion of housing 106, it will be appreciated that fluid inlet 112 may be in alternative locations. For example, fluid inlet 112 may be in a distal surface of housing 106 (the bottom of housing 106 in the Figures) or in lid 108.” [0025]). However, Pic does not explicitly disclose or detail the means by which the first flow of gas entrains the powder if the fluid inlet is located in the lid 108 in this alternate embodiment. There is not disclosure that the flow of gas would be introduced directly into the enclosure 104 rather than introduced via the filter 120 if the fluid inlet were located in the lid 108. Though Pic does not provide a “suggestion or motivation…to have gas flow around the proximal portion of the chamber” (Remarks, page 13), this suggestion was found in the disclosure of Milton (USPN 2987221), as detailed above. Because Pic discloses that the fluid inlet may be located on the lid 108 (Pic [0025]), one of ordinary skill in the art would have found it obvious to look to the disclosure of Milton for a teaching of how the fluid inlet could be adapted to be located proximal of the chamber such that the first flow of gases flows around the proximal portion of the chamber. Therefore, it is maintained that it would have been obvious to one having ordinary skill in the art to modify the first flow of gas from the first pressurized gas source of the therapeutic powder applicator of Pic to flow around at least a proximal portion of the chamber before entering the plurality of pores of the distal portion of the chamber based on the teachings of Milton to guide the first flow of gas directly to the therapeutic powder supported by the porous membrane (Milton [Col 3, lines 45-67]; Figure 2).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEAH J SWANSON/ Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783