DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 09, 2026 has been entered.
Claims 21-23 and 26-40 remain pending in the application. Claims 1-20 and 24-25 have been cancelled.
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 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 negated by the manner in which the invention was made.
Claims 21, 23-24, 26-28, 31-32, 34-36, and 39-40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gertner (US 20030181917) in view of Bates (USPN 0460458) in further view of Kablik et al. (US 20050205087).
Regarding claim 21, Gertner discloses an apparatus (Figure 1A) suitable for delivering at least one therapeutic agent to a target site, the apparatus comprising:
a connecting member (channel 16) having first (“an aperture at a Venturi constriction 19” [0033]) and second inlet ports (from pressurized fluid vessel 22) and an outlet port (portion of channel 16 extending to outlet port 12);
at least one container (reservoir 15) for holding a therapeutic agent (bioactive agent 20), wherein the first inlet port of the connecting member is selectively coupled to the container (“the reservoir 15 of bioactive agent, when present, can be connected to the means 11 for receiving a reservoir 15.” [0032]; “The reservoir can be permanently or removably affixed to the device body at the means for receiving a reservoir.” [0013]);
pressurized fluid (pressurized fluid 14) adapted to flow through the second inlet port of the connecting member (“flow of the pressurized fluid 14 from the pressurized vessel 22 through channel 16 in body 17, and optional tube 28, and out through the outlet port 12.” [0032]);
at least one tube member (nozzle 24) having proximal and distal ends (Figure 1A), wherein the proximal end of the tube member is coupled to the outlet port of the connecting member (Figure 1A), and the distal end of the tube member is sized to be placed in fluid communication with a target site (“The outlet or nozzle can include, or functionally interact with, a tube adapted to direct outlet gas and/or aerosol into a laparoscopic surgical site through a trocar.” [0015]),
wherein a flow of the pressurized fluid through the outlet port guides the therapeutic agent in a direction through the tube member for delivery of the therapeutic agent to the target site (“the surgical device is a body with a removably or permanently affixed pressurized fluid chamber; a means for receiving a reservoir; an outlet port; and, a channel that communicates between pressurized fluid chamber, the means for receiving a reservoir, and the outlet port. The channel has a Venturi constriction so that a gas passing from the means for receiving a pressurized fluid vessel to the outlet port aspirates a bioactive agent, resulting in an agent/fluid aerosol exiting the device through the outlet port.” [0010], see also [0038]);
the first inlet port being adjustable to selectively inhibit flow of the therapeutic agent from the container towards the tube member without inhibiting flow from a pressure source through the second inlet port (“the reservoir can comprise…an aperture, adjustable from substantially non-communicating to a position of open communication with the channel, is located between the channel of flowing gas and the reservoir internal space. With the aperture closed (substantially non-communicating) pressurized gas can be sprayed onto a surgical site to clear fluids without application of bioactive agents. The proportion of bioactive agent aspirated into the stream of gas can be adjusted by varying how far the aperture is opened.” [0040]),
wherein the therapeutic agent comprises a powder (“powder bioactive agent” [0040]);
wherein when the pressurized fluid flows from the second inlet port through the outlet port, it consequently creates a localized low pressure system as it passes by the first inlet port to cause the therapeutic agent to be suctioned out of the container and through the first inlet port (“The bioactive agent can be aspirated, with or without the aid of a Venturi constriction, into the channel by a relatively low pressure generated by the gas stream flowing past the means for receiving a reservoir. Aspiration can vary with the flow rate of the gas stream.” [0014]; “The body can have a channel connecting, e.g., the receiving means to the outlet port through a mixing chamber. The channel can be in fluid contact with a vessel of pressurized fluid through a means for receiving a pressurized fluid vessel so that released fluid flows past a means for receiving a reservoir in such a way as to create a relative low pressure capable of aspirating contents from the reservoir into the fluid (Venturi effect). A Venturi constriction can be located in the channel at the point where the released fluid passes the means for receiving a reservoir, to increase the efficiency of aspiration according to Bernoulli's Principle.” [0038]);
a single flow pathway extending between the container and the outlet port (Figure 1A, via “an aperture at a Venturi constriction 19” [0033]); and
wherein the connecting member is generally t-shaped wherein the second inlet port (from pressurized fluid vessel 22) is substantially parallel to a longitudinal axis of the connecting member (Figure 1A).
Gertner fails to explicitly teach a valve disposed at least partially distal to the container to selectively inhibit flow of the therapeutic agent from the container towards the tube member without inhibiting flow from a pressure source through the second inlet port, wherein when the valve is in a closed position, the pressurized fluid is prevented from flowing into the container, wherein the valve is disposed outside of a passageway between the second inlet port and the outlet port; wherein the valve is disposed to block the single flow pathway extending between the container and the outlet port, wherein the connecting member is a separate piece with a generally y-shape, wherein the first inlet port is disposed at an acute angle of between about 20 degrees to about 70 degrees with respect to a longitudinal axis of the connecting member.
Bates teaches an apparatus suitable for delivering at least one therapeutic agent to a target site (Figure 1), the apparatus comprising: a connecting member (conductor C) having first (vertical branch h) and second inlet port (arm a) and an outlet port (arm m); a container (liquid receptacle A) for holding a therapeutic agent (“liquid in the receptacle A” [Page 1, line 43]) coupled to the first inlet port (Figure 2; “The branch h fits a cork p in the neck of the liquid-receptacle.” [Page 1, lines 66-67]); wherein a flow of pressurized fluid through the outlet port guides the therapeutic agent in a direction through a tube member (discharge tube q) for delivery of the therapeutic agent to the target site (“Air being forced into the chamber e is distributed, a portion flowing down the passage f and a portion flowing through the passage g, where it meets the liquid rising through the passages l and forces it through the arm m into the flexible discharge tube or conductor q, from which it is emitted in the form of atomized spray or mist.” [Page 1, line 97 – Page 2, line 2]); and a valve (stop-cock s) disposed at least partially distal to the container (Figure 2) to selectively inhibit flow of the therapeutic agent from the container towards the tube member without inhibiting flow from a pressure source (bulb B) through the second inlet port, wherein when the valve is in a closed position, the pressurized fluid is prevented from flowing into the container (“In the vertical branch h of the conductor C is a stopcock s provided with ports t u which register with the passages g and l when the atomizer is in use and cuts off the egress of liquid from the receptacle A” [Page 1, lines 70-74], Figure 2 showing that pressurized fluid can still flow from chamber e to passage g when the stopcock s is closed); wherein the valve is disposed outside of a passageway between the second inlet port and the outlet port (Figures 1 and 2); wherein the valve is disposed to block a single flow pathway (passage l) extending between the container and the outlet port (“In the vertical branch h of the conductor C is a stopcock s provided with ports t u which register with the passages g and l when the atomizer is in use and cuts off the egress of liquid from the receptacle A” [Page 1, lines 70-74], Figure 2 showing that passage l is the only flow pathway extending between the container and the outlet port and passage l can be blocked by stopcock s), wherein the connecting member (conductor C) is a separate piece (Figure 2 showing conductor C, and all components of the apparatus as separate pieces: “C, a T-shaped conductor for air and liquid, to the horizontal arm a of which the bulb B or any suitable air-supplying device is attached” [Page 1, line 28-31]; “The branch h fits a cork p in the neck of the liquid-receptacle” [Page 1, lines 66-67]; “To the outer end of the arm m is attached a flexible soft discharge-tube q” [Page 1, line 77-78]) with a generally t-shaped (Figure 2).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the apparatus of Gertner to include a valve disposed at least partially distal to the container and outside of a passageway between the second inlet port and the outlet port to selectively inhibit flow of the therapeutic agent from the container towards the tube member without inhibiting flow from a pressure source through the second inlet port, wherein when the valve is in a closed position, the pressured fluid is prevented from flowing into the container based, the valve disposed to block the single flow pathway extending between the container and the outlet port on the teachings of Bates to prevent inadvertent delivery of the therapeutic agent when the apparatus is being transported (Bates [Page 1, lines 70-76]) and to modify the connecting member of the apparatus of Gertner to be a separate piece based on the teachings of Bates to allow each of the container, pressurized fluid source, and tube member to be individually attached to the connection member to ensure that the apparatus has the appropriate combination of components for the specific use of the apparatus, such as the appropriate amount of pressurized fluid, correct therapeutic agent, and appropriate length of tube member (Bates [Page 1, lines 25-31, 77-89).
Modified Gertner fails to explicitly teach the connecting member has a generally y-shape, wherein first inlet port is disposed at an acute angle of between about 20 degrees to about 70 degrees with respect to a longitudinal axis of the connecting member.
Kablik teaches an apparatus suitable for delivering at least one therapeutic agent to a
target site (powder spray device 100), the apparatus comprising a connecting member (housing
102) having first (receptacle portion 108) and second inlet ports (at handle portion 140) and an
outlet port (at barrel portion 138); the connecting member has a generally y-shape (Figure 6) wherein the first inlet port is disposed at an acute angle of between about 20 degrees to about 70 degrees with respect to a longitudinal axis of the connecting member (Figure 6; "the receptacle is constructed in such a way that when a reservoir is engaged therewith, the longitudinal axis of the reservoir inclines rearwardly and upwardly relative to the longitudinal axis of the barrel portion at an angle of about 45.degree." [0056]).
At the time of the invention, it would have been obvious to one having ordinary skill in
the art to modify the first inlet port of the apparatus of Gertner to be disposed at an acute angle of between about 20 degrees to about 70 degrees with respect to a longitudinal axis of the connecting member as opposed to disposed at a right angle, therefore providing the connecting member with a generally y-shape based on the teachings of Kablik to guide the therapeutic agent from the container to the first inlet in a manner that both allows all of the therapeutic agent to be delivered from the container and also prevents clogging (Kablik [0048-0052]).
Regarding claim 23, modified Gertner teaches the apparatus of claim 21 wherein the outlet port (portion of channel 16 extending to outlet port 12) of the connecting member is aligned along the longitudinal axis (Figure 1A showing at least part of the portion of channel 16 extending to outlet port 12 is aligned along the longitudinal axis).
Regarding claim 26, modified Gertner teaches the apparatus of claim 21 wherein the second inlet port (from pressurized fluid vessel 22) of the connecting member is disposed in closer proximity to the outlet port (portion of channel 16 extending to outlet 12), relative to a positioning of the first inlet port (“an aperture at a Venturi constriction 19” [0033]) with respect to the outlet port (Figure 1A, wherein the inlet into channel 16 from the pressurized fluid vessel 22 is vertically aligned with and therefore closer in vertical proximity to the portion of channel 16 extending to outlet 12, relative to the vertical distance between the aperture at Venturi constriction 19 and outlet 12).
Regarding claim 27, modified Gertner teaches the apparatus of claim 21 wherein the pressurized fluid originates from a pressure source comprising a compressed gas dispenser (“pressurized fluid vessel provided as a cartridge containing a compressed gas (e.g. CO.sub.2).” [0067]; “Pressurized fluid (typically a compressed, liquid or supercritical gas) from the vessel” [0032]).
Regarding claim 28, modified Gertner teaches the apparatus of claim 27 further comprising a regulating valve (control valve 13) disposed between the pressure source and the connecting member (Figure 1A; “a control valve 13 that regulates flow of the pressurized fluid 14 from the pressurized vessel 22 through channel 16 in body 17, and optional tube 28, and out through the outlet port 12.” [0032]).
Regarding claim 31, Gertner discloses an apparatus (Figure 1A) suitable for delivering at least one therapeutic agent to a target site, the apparatus comprising:
a connecting member (channel 16) having first (“an aperture at a Venturi constriction 19” [0033]) and second inlet ports (from pressurized fluid vessel 22) and an outlet port (portion of channel 16 extending to outlet port 12);
at least one container (reservoir 15) for holding a therapeutic agent (bioactive agent 20), wherein the first inlet port of the connecting member is selectively coupled to the container (“the reservoir 15 of bioactive agent, when present, can be connected to the means 11 for receiving a reservoir 15.” [0032]; “The reservoir can be permanently or removably affixed to the device body at the means for receiving a reservoir.” [0013]);
pressurized fluid (pressurized fluid 14) adapted to flow through the second inlet port of the connecting member (“flow of the pressurized fluid 14 from the pressurized vessel 22 through channel 16 in body 17, and optional tube 28, and out through the outlet port 12.” [0032]);
at least one tube member (nozzle 24) having proximal and distal ends (Figure 1A), wherein the proximal end of the tube member is coupled to the outlet port of the connecting member (Figure 1A), and the distal end of the tube member is sized to be placed in fluid communication with a target site (“The outlet or nozzle can include, or functionally interact with, a tube adapted to direct outlet gas and/or aerosol into a laparoscopic surgical site through a trocar.” [0015]),
wherein a provision of the pressurized fluid through the second inlet port and the outlet port is adapted to urge the therapeutic agent in a direction away from the container and through the first inlet port and the tube member for delivery of the therapeutic agent to the target site (“the surgical device is a body with a removably or permanently affixed pressurized fluid chamber; a means for receiving a reservoir; an outlet port; and, a channel that communicates between pressurized fluid chamber, the means for receiving a reservoir, and the outlet port. The channel has a Venturi constriction so that a gas passing from the means for receiving a pressurized fluid vessel to the outlet port aspirates a bioactive agent, resulting in an agent/fluid aerosol exiting the device through the outlet port.” [0010], see also [0038]);
the first inlet port being adjustable to selectively inhibit flow of the pressurized fluid into the container (“the reservoir can comprise…an aperture, adjustable from substantially non-communicating to a position of open communication with the channel, is located between the channel of flowing gas and the reservoir internal space. With the aperture closed (substantially non-communicating) pressurized gas can be sprayed onto a surgical site to clear fluids without application of bioactive agents. The proportion of bioactive agent aspirated into the stream of gas can be adjusted by varying how far the aperture is opened.” [0040]);
wherein the connecting member is generally t-shaped wherein the second inlet port (from pressurized fluid vessel 22) is substantially parallel to a longitudinal axis of the connecting member (Figure 1A);
wherein the outlet port (portion of channel 16 extending to outlet port 12) of the connecting member is aligned along the longitudinal axis (Figure 1A showing at least part of the portion of channel 16 extending to outlet port 12 is aligned along the longitudinal axis),
wherein the therapeutic agent comprises a powder (“powder bioactive agent” [0040]);
wherein when the pressurized fluid flows from the second inlet port through the outlet port, it consequently creates a localized low pressure system as it passes by the first inlet port to cause the therapeutic agent to be suctioned out of the container and through the first inlet port (“The bioactive agent can be aspirated, with or without the aid of a Venturi constriction, into the channel by a relatively low pressure generated by the gas stream flowing past the means for receiving a reservoir. Aspiration can vary with the flow rate of the gas stream.” [0014]; “The body can have a channel connecting, e.g., the receiving means to the outlet port through a mixing chamber. The channel can be in fluid contact with a vessel of pressurized fluid through a means for receiving a pressurized fluid vessel so that released fluid flows past a means for receiving a reservoir in such a way as to create a relative low pressure capable of aspirating contents from the reservoir into the fluid (Venturi effect). A Venturi constriction can be located in the channel at the point where the released fluid passes the means for receiving a reservoir, to increase the efficiency of aspiration according to Bernoulli's Principle.” [0038]); and
a single flow pathway extending between the container and the outlet port (Figure 1A, via “an aperture at a Venturi constriction 19” [0033]).
Gertner fails to explicitly disclose a valve configured to selectively inhibit flow of the pressurized fluid into the container, wherein the valve is disposed outside of a passageway between the second inlet port and the outlet port; wherein the connecting member is a separate piece with a generally y-shape, wherein the first inlet port is disposed at an acute angle of between about 20 to about 70 degrees with respect to the longitudinal axis; and wherein the valve is disposed to block the single flow pathway extending between the container and the outlet port.
Bates teaches an apparatus suitable for delivering at least one therapeutic agent to a target site (Figure 1), the apparatus comprising: a connecting member (conductor C) having first (vertical branch h) and second inlet port (arm a) and an outlet port (arm m); a container (liquid receptacle A) for holding a therapeutic agent (“liquid in the receptacle A” [Page 1, line 43]) coupled to the first inlet port (Figure 2; “The branch h fits a cork p in the neck of the liquid-receptacle.” [Page 1, lines 66-67]); wherein a provision of pressurized fluid through the second inlet port and outlet port is adapted to urge the therapeutic agent in a direction away from the container and through the first inlet port and a tube member (discharge tube q) for delivery of the therapeutic agent to the target site (“Air being forced into the chamber e is distributed, a portion flowing down the passage f and a portion flowing through the passage g, where it meets the liquid rising through the passages l and forces it through the arm m into the flexible discharge tube or conductor q, from which it is emitted in the form of atomized spray or mist.” [Page 1, line 97 – Page 2, line 2]); and a valve (stop-cock s) configured to selectively inhibit flow of the pressurized fluid into the container (Figure 2; “In the vertical branch h of the conductor C is a stopcock s provided with ports t u which register with the passages g and l when the atomizer is in use and cuts off the egress of liquid from the receptacle A” [Page 1, lines 70-74]), wherein the valve is disposed outside of a passageway between the second inlet port and the outlet port (Figures 1 and 2); wherein the valve is disposed to block a single flow pathway (passage l) extending between the container and the outlet port (“In the vertical branch h of the conductor C is a stopcock s provided with ports t u which register with the passages g and l when the atomizer is in use and cuts off the egress of liquid from the receptacle A” [Page 1, lines 70-74], Figure 2 showing that passage l is the only flow pathway extending between the container and the outlet port and passage l extending between the container and the outlet port can be blocked by stopcock s); and wherein the connecting member (conductor C) is a separate piece (Figure 2 showing conductor C, and all components of the apparatus as separate pieces: “C, a T-shaped conductor for air and liquid, to the horizontal arm a of which the bulb B or any suitable air-supplying device is attached” [Page 1, line 28-31]; “The branch h fits a cork p in the neck of the liquid-receptacle” [Page 1, lines 66-67]; “To the outer end of the arm m is attached a flexible soft discharge-tube q” [Page 1, line 77-78]) with a generally t-shaped (Figure 2).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the apparatus of Gertner to include a valve configured to selectively inhibit flow of the pressurized fluid into the container that is disposed outside of a passageway between the second inlet port and the outlet port, the valve disposed to block the single flow pathway extending between the container and the outlet port on the teachings of Bates to prevent inadvertent delivery of the therapeutic agent when the apparatus is being transported (Bates [Page 1, lines 70-76]) and to modify the connecting member of the apparatus of Gertner to be a separate piece based on the teachings of Bates to allow each of the container, pressurized fluid source, and tube member to be individually attached to the connection member to ensure that the apparatus has the appropriate combination of components for the specific use of the apparatus, such as the appropriate amount of pressurized fluid, correct therapeutic agent, and appropriate length of tube member (Bates [Page 1, lines 25-31, 77-89).
Modified Gertner fails to explicitly teach the connecting member has a generally y-shape, wherein first inlet port is disposed at an acute angle of between about 20 degrees to about 70 degrees with respect to a longitudinal axis of the connecting member.
Kablik teaches an apparatus suitable for delivering at least one therapeutic agent to a
target site (powder spray device 100), the apparatus comprising a connecting member (housing
102) having first (receptacle portion 108) and second inlet ports (at handle portion 140) and an
outlet port (at barrel portion 138); the connecting member has a generally y-shape (Figure 6) wherein the first inlet port is disposed at an acute angle of between about 20 degrees to about 70 degrees with respect to a longitudinal axis of the connecting member (Figure 6; "the receptacle is constructed in such a way that when a reservoir is engaged therewith, the longitudinal axis of the reservoir inclines rearwardly and upwardly relative to the longitudinal axis of the barrel portion at an angle of about 45.degree." [0056]).
At the time of the invention, it would have been obvious to one having ordinary skill in
the art to modify the first inlet port of the apparatus of Gertner to be disposed at an acute angle of between about 20 degrees to about 70 degrees with respect to a longitudinal axis of the connecting member as opposed to disposed at a right angle, therefore providing the connecting member with a generally y-shape based on the teachings of Kablik to guide the therapeutic agent from the container to the first inlet in a manner that both allows all of the therapeutic agent to be delivered from the container and also prevents clogging (Kablik [0048-0052]).
Regarding claim 32, modified Gertner teaches the apparatus of claim 31.
Modified Gertner fails to explicitly teach wherein the valve is disposed distal to the container and proximal to said tube member to selectively inhibit flow of the therapeutic agent through a distal region of the container and into the first inlet port without inhibiting flow from a pressure source through the second inlet port.
Bates teaches an apparatus suitable for delivering at least one therapeutic agent to a target site (Figure 1), the apparatus comprising: a connecting member (conductor C) having first (vertical branch h) and second inlet port (arm a) and an outlet port (arm m); a container (liquid receptacle A) coupled to the first inlet port (Figure 2; “The branch h fits a cork p in the neck of the liquid-receptacle.” [Page 1, lines 66-67]); wherein provision of a pressurized fluid through the second inlet port and the outlet port is adapted to urge the therapeutic agent in a direction away from the container and through the first inlet port and a tube member (discharge tube q) for delivery of the therapeutic agent to the target site (“Air being forced into the chamber e is distributed, a portion flowing down the passage f and a portion flowing through the passage g, where it meets the liquid rising through the passages l and forces it through the arm m into the flexible discharge tube or conductor q , from which it is emitted in the form of atomized spray or mist.” [Page 1, line 97 – Page 2, line 2]); and a valve (stop-cock s) disposed distal to the container (Figures 1 and 2) and proximal to said tube member (Figures 1 and 2) to selectively inhibit flow of the therapeutic agent through a distal region of the container and into the first inlet port without inhibiting flow from a pressure source (bulb B) through the second inlet port (“In the vertical branch h of the conductor C is a stopcock s provided with ports t u which register with the passages g and l when the atomizer is in use and cuts off the egress of liquid from the receptacle A” [Page 1, lines 70-74], Figure 2 showing that pressurized fluid can still flow from chamber e to passage g when the stopcock s is closed).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the apparatus of Gertner to include the valve is disposed distal to the container and proximal to said tube member to selectively inhibit flow of the therapeutic agent through a distal region of the container and into the first inlet port without inhibiting flow from a pressure source through the second inlet port based on the teachings of Bates to prevent inadvertent delivery of the therapeutic agent when the apparatus is being transported (Bates [Page 1, lines 70-76]).
Regarding claim 34, modified Gertner teaches the apparatus of claim 31 wherein the second inlet port (from pressurized fluid vessel 22) of the connecting member is disposed in closer proximity to the outlet port (portion of channel 16 extending to outlet port 12), relative to a positioning of the first inlet port (“an aperture at a Venturi constriction 19” [0033]) with respect to the outlet port (Figure 1A, wherein the inlet into channel 16 from the pressurized fluid vessel 22 is vertically aligned with and therefore closer in vertical proximity to the portion of channel 16 extending to outlet 12, relative to the vertical distance between the aperture at Venturi constriction 19 and outlet 12).
Regarding claim 35, modified Gertner teaches the apparatus of claim 31 wherein the pressurized fluid originates from a pressure source comprising a compressed gas dispenser (“pressurized fluid vessel provided as a cartridge containing a compressed gas (e.g. CO.sub.2).” [0067]; “Pressurized fluid (typically a compressed, liquid or supercritical gas) from the vessel” [0032]).
Regarding claim 36, modified Gertner teaches the apparatus of claim 27 further comprising a regulating valve (control valve 13) disposed between the pressure source and the connecting member (Figure 1A; “a control valve 13 that regulates flow of the pressurized fluid 14 from the pressurized vessel 22 through channel 16 in body 17, and optional tube 28, and out through the outlet port 12.” [0032]).
Regarding claim 39, Gertner discloses an apparatus (Figure 1A) suitable for delivering at least one therapeutic agent to a target site, the apparatus comprising:
at least one container (reservoir 15) for holding a therapeutic agent (bioactive agent 20), the container having an outlet end (at means 11: “Flow of bioactive agent into the flow of pressurized fluid in the body channel can be, e.g., by aspiration, e.g., through an aperture at a Venturi constriction 19” [0033]; “the reservoir 15 of bioactive agent, when present, can be connected to the means 11 for receiving a reservoir 15.” [0032]);
pressurized fluid (pressurized fluid 14) adapted to flow through an inlet port (opening into channel 16 from pressurized fluid vessel 22) of a connecting member (channel 16) and through an outlet port (portion of channel 16 extending to outlet port 12) of the connecting member (“flow of the pressurized fluid 14 from the pressurized vessel 22 through channel 16 in body 17, and optional tube 28, and out through the outlet port 12.” [0032]), wherein the pressurized fluid is adapted to flow past the outlet end of the container, wherein at least some of the pressurized fluid does not flow through the container (“the surgical device is a body with a removably or permanently affixed pressurized fluid chamber; a means for receiving a reservoir; an outlet port; and, a channel that communicates between pressurized fluid chamber, the means for receiving a reservoir, and the outlet port. The channel has a Venturi constriction so that a gas passing from the means for receiving a pressurized fluid vessel to the outlet port aspirates a bioactive agent, resulting in an agent/fluid aerosol exiting the device through the outlet port.” [0010], see also [0038]);
at least one tube member (nozzle 24) having proximal and distal ends (Figure 1A), wherein the proximal end of the tube member is disposed distal to the outlet end of the container (Figure 1A), and wherein the distal end of the tube member is sized to be placed in fluid communication with a target site (“The outlet or nozzle can include, or functionally interact with, a tube adapted to direct outlet gas and/or aerosol into a laparoscopic surgical site through a trocar.” [0015]),
wherein a flow of the pressurized fluid past the outlet end of the container guides the therapeutic agent in a direction away from the container and the tube member for delivery of the therapeutic agent to the target site (“the surgical device is a body with a removably or permanently affixed pressurized fluid chamber; a means for receiving a reservoir; an outlet port; and, a channel that communicates between pressurized fluid chamber, the means for receiving a reservoir, and the outlet port. The channel has a Venturi constriction so that a gas passing from the means for receiving a pressurized fluid vessel to the outlet port aspirates a bioactive agent, resulting in an agent/fluid aerosol exiting the device through the outlet port.” [0010], see also [0038]);
the outlet end of the container being adjustable to selectively inhibit flow of the therapeutic agent through a distal region of the container and into the tube member (“the reservoir can comprise…an aperture, adjustable from substantially non-communicating to a position of open communication with the channel, is located between the channel of flowing gas and the reservoir internal space. With the aperture closed (substantially non-communicating) pressurized gas can be sprayed onto a surgical site to clear fluids without application of bioactive agents. The proportion of bioactive agent aspirated into the stream of gas can be adjusted by varying how far the aperture is opened.” [0040]),
wherein the therapeutic agent comprises a powder (“powder bioactive agent” [0040]);
wherein when the pressurized fluid flows from the inlet port through the outlet port, it consequently creates a localized low pressure system as it passes by the container to cause the therapeutic agent to be suctioned out of the container (“The bioactive agent can be aspirated, with or without the aid of a Venturi constriction, into the channel by a relatively low pressure generated by the gas stream flowing past the means for receiving a reservoir. Aspiration can vary with the flow rate of the gas stream.” [0014]; “The body can have a channel connecting, e.g., the receiving means to the outlet port through a mixing chamber. The channel can be in fluid contact with a vessel of pressurized fluid through a means for receiving a pressurized fluid vessel so that released fluid flows past a means for receiving a reservoir in such a way as to create a relative low pressure capable of aspirating contents from the reservoir into the fluid (Venturi effect). A Venturi constriction can be located in the channel at the point where the released fluid passes the means for receiving a reservoir, to increase the efficiency of aspiration according to Bernoulli's Principle.” [0038]);
a single flow pathway extending between the container and the outlet port (Figure 1A, via “an aperture at a Venturi constriction 19” [0033]); and
wherein the connecting member is generally t-shaped wherein the second inlet port (from pressurized fluid vessel 22) is substantially parallel to a longitudinal axis of the connecting member (Figure 1A).
Gertner fails to explicitly teach a valve is disposed at least partially distal to the container to selectively inhibit flow of the therapeutic agent through a distal region of the container and into the tube member, wherein the valve is disposed outside of a passageway between the inlet port and the outlet port; wherein the valve is disposed to block the single flow pathway extending between the container and the outlet port; and wherein the connecting member is a separate piece with a generally y-shape, wherein the first inlet port is disposed at an acute angle of between about 20 degrees to about 70 degrees with respect to a longitudinal axis of the connecting member.
Bates teaches an apparatus suitable for delivering at least one therapeutic agent to a target site (Figure 1), the apparatus comprising: a container (liquid receptacle A) for holding a therapeutic agent (“liquid in the receptacle A” [Page 1, line 43]), the container having an outlet end (at cork p, via brand h); pressurized fluid adapted to flow through an inlet port (arm a) of a connecting member (conductor C) and through an outlet port (arm m) of the connecting member (Figure 2), wherein the pressurized fluid is adapted to flow past the outlet end of the container, wherein at least some of the pressurized fluid does not flow through the container (“Air being forced into the chamber e is distributed, a portion flowing down the passage f and a portion flowing through the passage g, where it meets the liquid rising through the passages l and forces it through the arm m into the flexible discharge tube or conductor q , from which it is emitted in the form of atomized spray or mist.” [Page 1, line 97 – Page 2, line 2]: wherein the air flow through port u into passage f into the receptacle A and out of receptacle A through port t into passage g; and wherein a portion of the air flows directly through passage g); wherein a valve (stop-cock s) is disposed at least partially distal to the container (Figure 2) to selectively inhibit flow of the therapeutic agent through a distal region of the container and into a tube member (discharge tube q; “In the vertical branch h of the conductor C is a stopcock s provided with ports t u which register with the passages g and l when the atomizer is in use and cuts off the egress of liquid from the receptacle A” [Page 1, lines 70-74]); wherein the valve is disposed outside of a passageway between the inlet port and the outlet port (Figures 1 and 2); and wherein the valve is disposed to block a single flow pathway (passage l) extending between the container and the outlet port (“In the vertical branch h of the conductor C is a stopcock s provided with ports t u which register with the passages g and l when the atomizer is in use and cuts off the egress of liquid from the receptacle A” [Page 1, lines 70-74], Figure 2 showing that passage l is the only flow pathway extending between the container and the outlet port and passage l extending between the container and the outlet port can be blocked by stopcock s); and wherein the connecting member (conductor C) is a separate piece (Figure 2 showing conductor C, and all components of the apparatus as separate pieces: “C, a T-shaped conductor for air and liquid, to the horizontal arm a of which the bulb B or any suitable air-supplying device is attached” [Page 1, line 28-31]; “The branch h fits a cork p in the neck of the liquid-receptacle” [Page 1, lines 66-67]; “To the outer end of the arm m is attached a flexible soft discharge-tube q” [Page 1, line 77-78]) with a generally t-shaped (Figure 2).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the apparatus of Gertner to include a valve disposed at least partially distal to the container and outside of a passageway between the inlet port and the outlet port to selectively inhibit flow of the therapeutic agent through a distal region of the container and into the tube member, the valve disposed to block the single flow pathway extending between the container and the outlet port on the teachings of Bates to prevent inadvertent delivery of the therapeutic agent when the apparatus is being transported (Bates [Page 1, lines 70-76]) and to modify the connecting member of the apparatus of Gertner to be a separate piece based on the teachings of Bates to allow each of the container, pressurized fluid source, and tube member to be individually attached to the connection member to ensure that the apparatus has the appropriate combination of components for the specific use of the apparatus, such as the appropriate amount of pressurized fluid, correct therapeutic agent, and appropriate length of tube member (Bates [Page 1, lines 25-31, 77-89).
Modified Gertner fails to explicitly teach the connecting member has a generally y-shape, wherein first inlet port is disposed at an acute angle of between about 20 degrees to about 70 degrees with respect to a longitudinal axis of the connecting member.
Kablik teaches an apparatus suitable for delivering at least one therapeutic agent to a
target site (powder spray device 100), the apparatus comprising a connecting member (housing
102) having first (receptacle portion 108) and second inlet ports (at handle portion 140) and an
outlet port (at barrel portion 138); the connecting member has a generally y-shape (Figure 6) wherein the first inlet port is disposed at an acute angle of between about 20 degrees to about 70 degrees with respect to a longitudinal axis of the connecting member (Figure 6; "the receptacle is constructed in such a way that when a reservoir is engaged therewith, the longitudinal axis of the reservoir inclines rearwardly and upwardly relative to the longitudinal axis of the barrel portion at an angle of about 45.degree." [0056]).
At the time of the invention, it would have been obvious to one having ordinary skill in
the art to modify the first inlet port of the apparatus of Gertner to be disposed at an acute angle of between about 20 degrees to about 70 degrees with respect to a longitudinal axis of the connecting member as opposed to disposed at a right angle, therefore providing the connecting member with a generally y-shape based on the teachings of Kablik to guide the therapeutic agent from the container to the first inlet in a manner that both allows all of the therapeutic agent to be delivered from the container and also prevents clogging (Kablik [0048-0052]).
Regarding claim 40, modified Gertner teaches the apparatus of claim 39 wherein the pressurized fluid originates from a pressure source comprising a compressed gas dispenser (“pressurized fluid vessel provided as a cartridge containing a compressed gas (e.g. CO.sub.2).” [0067]; “Pressurized fluid (typically a compressed, liquid or supercritical gas) from the vessel” [0032]).
Claims 22, 29, 33, and 37 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gertner (US 20030181917) in view of Bates (USPN 0460458) in further view of Kablik et al. (US 20050205087) as applied in claims 21 and 31 above, and further in view of Nielson (US 2003/0023202).
Regarding claim 22, modified Gertner teaches the apparatus of claim 21.
Modified Gertner fails to explicitly teach the container comprises a proximal end segment that is compressible relative to a distal end segment.
Nielson teaches an apparatus suitable for delivering at least one therapeutic agent to a target site (delivery apparatus 2), the apparatus comprising a connecting member (Figure 1) having first (necks 111) and second inlet ports (arms 122) and an outlet port (first Y-junction 114 and delivery tube 104); at least one container (syringes 101 and 102) selectively coupled ot the first inlet port (“The open end of nozzle 112 of both syringes 101 and 102 is situated within and forms a fluid tight connection with one end of first collars 110.” [0019]), and a pressurized fluid adapted to flow through the second inlet port of the connecting member (“Arms 122 terminate in a second Y-junction 115 which connects with a fluid and gas tight connection into third collar 107 at one end.” [0021]); wherein the container comprises a proximal end segment (compressor 119) that is compressible relative to a distal end segment (distal end of cylindrical body 117; “The plunger 118 is slidingly engaged within the cylindrical body 117 in such a way that the outer surface of compressor 119 remains in contact with the inner surface of the cylindrical body 117.” [0018]; “The finger engagers 103 of the syringes 101 and 102 are depressed which allows the compressors 119 to exert pressure on the respective fibrin precursor solutions within the syringes 101 and 102 forcing the solutions out through the respective nozzles 112 through first collars 110 and into mixing chamber 116.” [0022]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the container of the apparatus of Gertner to comprise a proximal end segment that is compressible relative to a distal end segment based on the teachings of Nielson allow the user to manually deliver the therapeutic agent from the container (Nielson [0022]).
Regarding claim 29, modified Gertner teaches the apparatus of claim 21.
Modified Gertner fails to explicitly teach the container comprises a syringe having proximal and distal regions, wherein the distal region is adapted to be coupled to the first inlet port of the connecting member, and wherein the proximal region comprises a plunger.
Nielson teaches an apparatus suitable for delivering at least one therapeutic agent to a target site (delivery apparatus 2), the apparatus comprising a connecting member (Figure 1) having first (necks 111) and second inlet ports (arms 122) and an outlet port (first Y-junction 114 and delivery tube 104); at least one container (syringes 101 and 102) selectively coupled ot the first inlet port (“The open end of nozzle 112 of both syringes 101 and 102 is situated within and forms a fluid tight connection with one end of first collars 110.” [0019]), and a pressurized fluid adapted to flow through the second inlet port of the connecting member (“Arms 122 terminate in a second Y-junction 115 which connects with a fluid and gas tight connection into third collar 107 at one end.” [0021]); wherein the container comprises a syringe (syringe 101, 102) having proximal (plungers 118 having finger engages 103 and compressors 119) and distal regions (cylindrical body 117 having nozzle 112), wherein the distal region is adapted to be coupled to the first inlet port of the connecting member (“The open end of nozzle 112 of both syringes 101 and 102 is situated within and forms a fluid tight connection with one end of first collars 110” [0019]), and wherein the proximal region comprises a plunger (plungers 118).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the container of the apparatus of Gertner to comprise a syringe having proximal and distal regions, wherein the distal region is adapted to be coupled to the first inlet port of the connecting member, and wherein the proximal region comprises a plunger based on the teachings of Nielson allow the user to manually deliver the therapeutic agent from the container (Nielson [0022]).
Regarding claim 33, modified Gertner teaches the apparatus of claim 31.
Modified Gertner fails to explicitly teach the container comprises a proximal end segment that is compressible relative to a distal end segment.
Nielson teaches an apparatus suitable for delivering at least one therapeutic agent to a target site (delivery apparatus 2), the apparatus comprising a connecting member (Figure 1) having first (necks 111) and second inlet ports (arms 122) and an outlet port (first Y-junction 114 and delivery tube 104); at least one container (syringes 101 and 102) selectively coupled ot the first inlet port (“The open end of nozzle 112 of both syringes 101 and 102 is situated within and forms a fluid tight connection with one end of first collars 110.” [0019]), and a pressurized fluid adapted to flow through the second inlet port of the connecting member (“Arms 122 terminate in a second Y-junction 115 which connects with a fluid and gas tight connection into third collar 107 at one end.” [0021]); wherein the container comprises a proximal end segment (compressor 119 103) that is compressible relative to a distal end segment (distal end of cylindrical body 117; “The plunger 118 is slidingly engaged within the cylindrical body 117 in such a way that the outer surface of compressor 119 remains in contact with the inner surface of the cylindrical body 117.” [0018]; “The finger engagers 103 of the syringes 101 and 102 are depressed which allows the compressors 119 to exert pressure on the respective fibrin precursor solutions within the syringes 101 and 102 forcing the solutions out through the respective nozzles 112 through first collars 110 and into mixing chamber 116.” [0022]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the container of the apparatus of Gertner to comprises a proximal end segment that is compressible relative to a distal end segment based on the teachings of Nielson allow the user to manually deliver the therapeutic agent from the container (Nielson [0022]).
Regarding claim 37, modified Gertner teaches the apparatus of claim 31.
Modified Gertner fails to explicitly teach a syringe having proximal and distal regions, wherein the distal region is adapted to be coupled to the first inlet port of the connecting member, and wherein the proximal region comprises a plunger.
Nielson teaches an apparatus suitable for delivering at least one therapeutic agent to a target site (delivery apparatus 2), the apparatus comprising a connecting member (Figure 1) having first (necks 111) and second inlet ports (arms 122) and an outlet port (first Y-junction 114 and delivery tube 104); at least one container (syringes 101 and 102) selectively coupled ot the first inlet port (“The open end of nozzle 112 of both syringes 101 and 102 is situated within and forms a fluid tight connection with one end of first collars 110.” [0019]), and a pressurized fluid adapted to flow through the second inlet port of the connecting member (“Arms 122 terminate in a second Y-junction 115 which connects with a fluid and gas tight connection into third collar 107 at one end.” [0021]); wherein the container comprises a syringe (syringe 101, 102) having proximal (plungers 118 having finger engages 103 and compressors 119) and distal regions (cylindrical body 117 having nozzle 112), wherein the distal region is adapted to be coupled to the first inlet port of the connecting member (“The open end of nozzle 112 of both syringes 101 and 102 is situated within and forms a fluid tight connection with one end of first collars 110” [0019]), and wherein the proximal region comprises a plunger (plungers 118).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the container of the apparatus of Gertner to comprise a syringe having proximal and distal regions, wherein the distal region is adapted to be coupled to the first inlet port of the connecting member, and wherein the proximal region comprises a plunger based on the teachings of Nielson allow the user to manually deliver the therapeutic agent from the container (Nielson [0022]).
Claims 30 and 38 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gertner (US 20030181917) in view of Bates (USPN 0460458) in further view of Kablik et al. (US 20050205087) as applied in claims 21 and 31 above, and further in view of Baran et al. (US 2005/0125002).
Regarding claim 30, modified Gertner teaches the apparatus of claim 21.
Modified Gertner fails to explicitly teach a needle coupled to the distal end of the tube member.
Baran teaches an apparatus suitable for delivering at least one therapeutic agent to a target site (system 10), the apparatus comprising: at least one container for holding a therapeutic agent (“Various types of sources of substances are contemplated for use with the embodiments discussed above. In mulitilumen embodiments, any of a number of known pump systems may be connected to the proximal ends of the catheter to supply dry or liquid substances.” [0067]); at least one tube member (catheter 16) sized to be place in fluid communication of with a target site to deliver the therapeutic agent (Figures 3A-3C); further comprising a needle (introducer needle 18) coupled to the distal end of the tube member (Figures 3A-3C).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the apparatus of Gertner to include a needle coupled to the distal end of the tube member based on the teachings of Baran to allow the apparatus to be positioned in a body cavity through the abdominal wall, such as during laparoscopic surgery (Baran [0006] and [0040]).
Regarding claim 38, modified Gertner teaches the apparatus of claim 31.
Modified Gertner fails to explicitly teach a needle coupled to the distal end of the tube member.
Baran teaches an apparatus suitable for delivering at least one therapeutic agent to a target site (system 10), the apparatus comprising: at least one container for holding a therapeutic agent (“Various types of sources of substances are contemplated for use with the embodiments discussed above. In mulitilumen embodiments, any of a number of known pump systems may be connected to the proximal ends of the catheter to supply dry or liquid substances.” [0067]); at least one tube member (catheter 16) sized to be place in fluid communication of with a target site to deliver the therapeutic agent (Figures 3A-3C); further comprising a needle (introducer needle 18) coupled to the distal end of the tube member (Figures 3A-3C).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the apparatus of Gertner to include a needle coupled to the distal end of the tube member based on the teachings of Baran to allow the apparatus to be positioned in a body cavity through the abdominal wall, such as during laparoscopic surgery (Baran [0006] and [0040]).
Response to Arguments
Applicant’s arguments with respect to claims 21-23 and 26-40 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Specifically, the amendment to independent claims 21, 31, and 39 of “wherein the connecting member is a separate piece with a generally y- shape, wherein the first inlet port is disposed at an acute angle of between about 20 degrees to about 70 degrees with respect to a longitudinal axis of the connecting member, and wherein the second inlet port is substantially parallel to the longitudinal axis” was found in the combination of the discloses of Gertner (US 20030181917), Bates (USPN 0460458), and Kablik et al. (US 20050205087), as detailed in the rejections above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Terakura et al. (USPN 5445612) discloses an apparatus (100) comprising a connecting member (passage unit 50) that is a separate piece (Figure 5) for the purpose of ensuring sanitation in the apparatus (“the passage unit 50 is freely exchangeable against the powdered medicament-mixed gas injecting apparatus 100, thus free from troubles in terms of sanitation.” [Col 9, lines 60-62]).
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/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783