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 .
Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20 recites “wherein the passing the gas through the plurality of openings disperses the liquid.” The claim should read “wherein passing the gas through the plurality of openings disperses the liquid.” As written, the inclusion of “the” before the verb “passing” creates a grammatical ambiguity that renders the scope of the method step unclear.
Appropriate correction is required.
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, 2, 3, 4, 5, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Osborne et al. (US 2011/0106054A1; hereinafter “Osborne”) in view of Preissman et al. (US 5,833,652A1; hereinafter “Preissman”).
In relation to independent claim 1, the claim recites: a medical device comprising: a first inlet for receiving a first fluid; a second inlet for receiving a second fluid; and a mixing body including: a first body defining a first lumen, wherein the first lumen is in fluid communication with the first inlet such that the first lumen receives the first fluid from the first inlet; and a second body disposed within the first lumen, wherein the second body defines a second lumen, wherein the second lumen is in fluid communication with the second inlet, such that the second lumen receives the second fluid from the second inlet, and wherein a radially outer surface of the second body has a plurality of openings, such that the first lumen and the second lumen are in fluid communication via the plurality of openings.
A medical device;
Osborne discloses a medical device. Specifically, Osborne discloses: “[d]isclosed is a multi-lumen mixing device”. (Osborne; Abstract.)
a first inlet for receiving a first fluid;
Osborne discloses a first inlet for receiving a first fluid. Specifically, Osborne discloses: “tube 139 couples reservoir 122 to lumen 142 through coupling 134.” (Osborne ¶ [0022].)
a second inlet for receiving a second fluid;
Osborne discloses a second inlet for receiving a second fluid. Specifically, Osborne discloses: “[t]ube 138 couples reservoir 112 to lumen 152 through coupling 133”. (Osborne ¶ [0022].)
and a mixing body;
Osborne discloses a mixing body. Specifically, Osborne discloses: “[m]ulti-lumen mixing device 130 generally includes an elongate element 140”. (Osborne ¶ [0022].)
a first body defining a first lumen, wherein the first lumen is in fluid communication with the first inlet such that the first lumen receives the first fluid from the first inlet;
Osborne discloses a first body defining a first lumen, wherein the first lumen is in fluid communication with the first inlet such that the first lumen receives the first fluid from the first inlet. Specifically, Osborne discloses: “elongate element 140, for example a needle or catheter, defining lumen 142” and “reagent 124 passes through tube 139 to lumen 142.” (Osborne ¶ [0022], [0026].)
and a second body disposed within the first lumen, wherein the second body defines a second lumen,
Osborne discloses a second body disposed within the first lumen, wherein the second body defines a second lumen. Specifically, Osborne discloses: “cannula 150 defining lumen 152” and “[c]annula support 136 supports and secures cannula 150 within elongate element 140 in a coaxial arrangement.” (Osborne ¶ [0022].)
wherein the second lumen is in fluid communication with the second inlet, such that the second lumen receives the second fluid from the second inlet,
Osborne discloses wherein the second lumen is in fluid communication with the second inlet, such that the second lumen receives the second fluid from the second inlet. Specifically, Osborne discloses: “reagent 114 passes through tube 138 to lumen 152”. (Osborne ¶ [0026].)
and wherein a radially outer surface of the second body has a plurality of openings, such that the first lumen and the second lumen are in fluid communication via the plurality of openings.
Osborne discloses wherein a radially outer surface of the second body has openings, such that the first lumen and the second lumen are in fluid communication via the openings. Specifically, Osborne discloses: “[p]orts 155 and 156 provide access between lumen 152 and lumen 142”. (Osborne ¶ [0025].) To the extent Osborne does not expressly disclose that the openings are a “plurality of openings” on a radially outer surface, Preissman fills this gap by disclosing a plurality of openings on an outer surface of an inner lumen. Specifically, Preissman discloses: “the combining step is carried out by flowing the second component through a plurality of openings into the first lumen.” (Preissman; claim 12.)
Motivation to combine.
It would have been obvious to combine Osborne with Preissman because both relate to multi-lumen mixing catheters. A person of ordinary skill in the art would have been motivated to incorporate Preissman’s teaching of a plurality of openings into Osborne’s coaxial cannula system to provide more even and distributed mixing of the two reagents as they pass from the inner lumen to the outer lumen.
In relation to claim 2, this claim depends from claim 1 and further recites: the medical device of claim 1, wherein the first body is tubular.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the first body is tubular.
Osborne discloses wherein the first body is tubular. Specifically, Osborne discloses: “elongate element 140, for example a needle or catheter”. (Osborne ¶ [0022].)
Motivation to combine.
It would have been obvious to combine the base combination of Osborne and Preissman because a needle or catheter is inherently tubular to define a lumen, as is standard in the medical device art. A person of ordinary skill in the art would have been motivated to use a tubular body to facilitate insertion into a patient’s vasculature or body lumens.
In relation to claim 3, this depends from claim 1 and further recites: the medical device of claim 1, wherein the second body is tubular.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the second body is tubular.
Osborne discloses wherein the second body is tubular. Specifically, Osborne discloses: “[c]annula 150 is formed from a metallic tube”. (Osborne ¶ [0032].)
Motivation to combine.
It would have been obvious to combine the base combination of Osborne and Preissman because forming the inner body as a metallic tube provides structural rigidity for the coaxial arrangement. A person of ordinary skill in the art would have been motivated to use a tubular inner body to reliably define the inner lumen and support the mixing ports.
In relation to claim 4, this claim depends from claim 1 and further recites: the medical device of claim 1, wherein the first body and the second body are monolithically formed from a single piece of material.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the first body and the second body are monolithically formed from a single piece of material.
Osborne discloses that the inner cannula and the outer element may be formed as a single piece. Specifically, Osborne discloses that the mixing feature is formed from the cannula itself: “[c]annula 150 is formed from a metallic tube in the illustrated embodiment with coupling 133 including a proximal luer fitting with the distal portion of metallic tube 150 forming mixing portion 162 by being crimped and formed into a spiral mixer configuration.” (Osborne ¶ [0032].) Osborne further discloses that the element can be formed as a single molded structure: “[i]n yet other embodiments, element 140 can be molded or formed as the illustrated configuration.” (Osborne ¶ [0053].) To the extent Osborne does not expressly disclose that the first body and the second body are monolithically formed from a single piece of material as distinct from the mixing feature being integrally formed with the cannula, Osborne itself discloses that the mixing feature and cannula are unitarily composed: “the mixing element and the cannula are unitarily composed of a single piece.” (Osborne; claim 6.)
Motivation to combine.
It would have been obvious to combine the base combination of Osborne and Preissman because forming the inner and outer bodies as a single piece is a well-known manufacturing technique for multi-lumen catheters. A person of ordinary skill in the art would have been motivated to form the first and second bodies monolithically from a single piece of material to simplify manufacturing, reduce assembly steps, and prevent potential leakage at joints between the first and second bodies.
In relation to claim 5, this claim depends from claim 1 and further recites: the medical device of claim 1, wherein the first lumen is coaxial with the second lumen.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the first lumen is coaxial with the second lumen.
Osborne discloses wherein the first lumen is coaxial with the second lumen. Specifically, Osborne discloses: “a cannula defining the first lumen and passing through the second lumen in a co-axial relationship.” (Osborne; claim 5.)
Motivation to combine.
It would have been obvious to combine the base combination of Osborne and Preissman because a coaxial arrangement provides for a compact device profile. A person of ordinary skill in the art would have been motivated to use a coaxial lumen arrangement to minimize the overall outer diameter of the medical device while maintaining two distinct fluid paths.
In relation to claim 8, this claim depends from claim 1 and further recites: the medical device of claim 1, wherein the mixing body is configured such that the second fluid flows into the first lumen through the plurality of openings, thereby forming a combination of the first fluid and the second fluid within the first lumen.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the mixing body is configured such that the second fluid flows into the first lumen through the plurality of openings, thereby forming a combination of the first fluid and the second fluid within the first lumen.
Osborne discloses wherein the mixing body is configured such that the second fluid flows into the first lumen through the openings, thereby forming a combination. Specifically, Osborne discloses: “[r]eagent 114 then is expelled from lumen 152 through ports 155 and/or 156 to co-mingle with reagent 124 in lumen 142.” (Osborne ¶ [0026].)
Motivation to combine.
It would have been obvious to combine the base combination of Osborne and Preissman because flowing the inner fluid outward into the outer lumen allows for efficient mixing. A person of ordinary skill in the art would have been motivated to configure the flow path in this manner to utilize the outer lumen as a mixing chamber before the combined fluid exits the device.
In relation to claim 9, this claim depends from claim 8 and further recites: the medical device of claim 8, further comprising an outlet that is configured to receive the combination of the first fluid and the second fluid from the first lumen.
Base rejection incorporated.
The rejection of claim 8 is incorporated herein.
further comprising an outlet that is configured to receive the combination of the first fluid and the second fluid from the first lumen.
Osborne discloses an outlet that is configured to receive the combination of the first fluid and the second fluid from the first lumen. Specifically, Osborne discloses: “mixed reagents 114 and 124 are expelled from multi-lumen mixing device 130 through ports 146 and 147.” (Osborne ¶ [0026].)
Motivation to combine.
It would have been obvious to combine the base combination of Osborne and Preissman because an outlet is necessary to deliver the mixed fluids to the patient. A person of ordinary skill in the art would have been motivated to provide an outlet to ensure the combined therapeutic agents can be properly discharged from the device to the target tissue.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Osborne et al. (US 2011/0106054A1; hereinafter “Osborne”) in view of Preissman et al. (US 5,833,652A1; hereinafter “Preissman”), as discussed above, and in further view of Favreau et al. (US2021/0162175A1; hereinafter “Favreau”).
In relation to claim 6, this claim depends from claim 1 and further recites: the medical device of claim 1, wherein the mixing body is sized so as to be received within a working channel of a scope.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the mixing body is sized so as to be received within a working channel of a scope.
Osborne discloses a mixing body, but Osborne does not expressly disclose it is sized to be received within a working channel of a scope. Favreau fills this gap by disclosing a delivery device sized for an endoscope working channel. Specifically, Favreau discloses: “[a] cross-sectional diameter of sheath 14 may be such that sheath 14 can be advanced through a working channel of an endoscope.” (Favreau ¶ [0019].)
Motivation to combine.
It would have been obvious to combine the base combination of Osborne and Preissman with Favreau because both relate to fluid delivery devices for medical procedures. A person of ordinary skill in the art would have been motivated to incorporate Favreau’s teaching of sizing the device for an endoscope working channel into the base system to allow the mixing device to be delivered minimally invasively to remote treatment sites within the body.
Claims 7, 11, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Osborne et al. (US 2011/0106054A1; hereinafter “Osborne”) in view of Preissman et al. (US 5,833,652A1; hereinafter “Preissman”), as discussed above, and in further view of Peindl et al. (US2009/0209916A1; hereinafter “Peindl”).
In relation to claim 7, this claim depends from claim 1 and further recites: the medical device of claim 1, wherein the first fluid is a liquid, and the second fluid is a gas.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the first fluid is a liquid, and the second fluid is a gas.
Osborne discloses mixing two fluids, but to the extent Osborne does not expressly disclose the first fluid is a liquid and the second fluid is a gas, Peindl fills this gap by disclosing a gas assisted tissue sealant applicator. Specifically, Peindl discloses: “[t]he system shown is a gas assisted application system, which includes a multiple agent applicator device 10, a dual syringe material applicator 12, a control unit 14 and a pressurized sterile gas or air supply 16.” (Peindl ¶ [0043].)
Motivation to combine.
It would have been obvious to combine the base combination of Osborne and Preissman with Peindl because all references relate to mixing devices for medical applications. A person of ordinary skill in the art would have been motivated to incorporate Peindl’s teaching of mixing a liquid agent with a gas into the base system to assist in dispersing, spraying, or nebulizing the liquid agent at the target site.
In relation to claim 11, this claim depends from claim 1 and further recites: the medical device of claim 1, further comprising: an outer sheath defining the first inlet; and an inner sheath at least partially within the outer sheath and defining the second inlet.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
further comprising: an outer sheath defining the first inlet; and an inner sheath at least partially within the outer sheath and defining the second inlet.
Osborne discloses fluid inlets, but to the extent Osborne does not expressly disclose an outer sheath and an inner sheath defining the inlets, Peindl fills this gap by disclosing a delivery shaft with fluid conduits. Specifically, Peindl discloses: “Delivery shaft 18 also includes a first fluid conduit 36 and a second fluid conduit 38 extending through lumen 28.” (Peindl ¶ [0047].)
Motivation to combine.
It would have been obvious to combine the base combination of Osborne and Preissman with Peindl because using sheaths and conduits protects the fluid paths. A person of ordinary skill in the art would have been motivated to incorporate Peindl’s teaching of an outer sheath containing inner fluid conduits into the base system to provide a robust, flexible delivery shaft that can navigate tortuous anatomy while maintaining separate fluid supplies.
In relation to claim 12, this claim depends from claim 11 and further recites: the medical device of claim 11, wherein a radially outer wall of the outer sheath includes a side opening, and wherein the inner sheath is configured to receive the second fluid through the side opening.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein a radially outer wall of the outer sheath includes a side opening, and wherein the inner sheath is configured to receive the second fluid through the side opening.
Peindl discloses an outer delivery shaft with a gas passageway through its body wall. Specifically, Peindl discloses: “body 33 includes a gas passageway 66 that communicates the stream of gas supplied by line 62 to lumen 28 of delivery shaft 18.” (Peindl ¶ [0049].) To the extent Peindl does not expressly disclose a side opening in the radially outer wall of an outer sheath through which an inner sheath receives a second fluid, Osborne fills this gap by disclosing a side port in the outer elongate element. Specifically, Osborne discloses that the outer elongate element includes a side port: “multi-lumen mixing device 130 is comparatively rigid with a needle like catheter 140 including a pencil tip 144 and side port 146.” (Osborne ¶ [0031].)
Motivation to combine.
It would have been obvious to combine the base combination of Osborne, Preissman, and Peindl because providing a side opening in the outer sheath wall allows fluid to enter the device laterally without requiring a proximal end connection. A person of ordinary skill in the art would have been motivated to incorporate a side opening into the outer sheath to allow the inner sheath to receive a second fluid from a lateral supply line, thereby enabling a more compact proximal handle configuration and facilitating use through a working channel of an endoscope.
In relation to claim 13, this depends from claim 11 and further recites: the medical device of claim 11, wherein a proximal end of the first body is coupled to a distal end of the outer sheath, and wherein a proximal end of the second body is coupled to a distal end of the inner sheath.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein a proximal end of the first body is coupled to a distal end of the outer sheath, and wherein a proximal end of the second body is coupled to a distal end of the inner sheath.
Peindl discloses that a proximal end of a body (formable section) is coupled to a distal end of an outer delivery shaft. Specifically, Peindl discloses: “[f]ormable section 24 includes a proximal end 104 that is attached to distal end 22 of delivery shaft 18.” (Peindl ¶ [0053].) Peindl further discloses that the inner fluid conduits within the outer delivery shaft are in fluid communication with the lumens of the formable section at the coupling point. Specifically, Peindl discloses: “[w]hen the coupling member 108 is coupled to delivery shaft 18, first extension 148 aligns and mates sealing with first fluid conduit 36, so that fluid channel 152 is in fluid communication with the first fluid conduit 36.” (Peindl ¶ [0059].) To the extent Peindl does not expressly disclose a separate inner sheath whose distal end is coupled to a proximal end of a second body, Osborne fills this gap by disclosing that the inner cannula passes through and is secured within the outer elongate element at a coupling point. Specifically, Osborne discloses: “[c]annula support 136 supports and secures cannula 150 within elongate element 140 in a coaxial arrangement.” (Osborne ¶ [0022].)
Motivation to combine.
It would have been obvious to combine the base combination of Osborne, Preissman, and Peindl because coupling the proximal ends of the inner and outer mixing bodies to the respective distal ends of the inner and outer sheaths ensures continuous, leak-free fluid paths from the supply sheaths to the mixing body. A person of ordinary skill in the art would have been motivated to couple the first body to the distal end of the outer sheath and the second body to the distal end of the inner sheath to maintain the coaxial fluid separation from the proximal supply all the way to the mixing region.
Claims 10, 14, 15, 16, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Osborne et al. (US 2011/0106054A1; hereinafter “Osborne”) in view of Preissman et al. (US 5,833,652A1; hereinafter “Preissman”), as discussed above, and in further view of Zurecki et al. (US2008/0048047A1; hereinafter “Zurecki”).
In relation to claim 10, this claim depends from claim 1 and further recites: the medical device of claim 1, wherein the first fluid is a gas and the second fluid is a liquid.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the first fluid is a gas and the second fluid is a liquid.
Osborne discloses mixing two fluids, but to the extent Osborne does not expressly disclose the first fluid is a gas and the second fluid is a liquid, Zurecki fills this gap by disclosing a coaxial tube-in-tube device where gas is in the outer lumen and liquid is in the inner lumen. Specifically, Zurecki discloses: “the throttling gas G1 is introduced into the annular space” and “the cryogenic liquid L1 is introduced into the inner conduit”. (Zurecki ¶ [0094], [0095].)
Motivation to combine.
It would have been obvious to combine the base combination of Osborne and Preissman with Zurecki because all references relate to coaxial fluid mixing devices. A person of ordinary skill in the art would have been motivated to incorporate Zurecki’s teaching of placing gas in the outer lumen and liquid in the inner lumen into the base system to allow the expanding gas to efficiently disperse and propel the liquid outward.
In relation to claim 14, this claim depends from claim 1 and further recites: the medical device of claim 1, wherein the mixing body is configured such that the first fluid flows into the second lumen through the plurality of openings, thereby forming a combination of the first fluid and the second fluid within the second lumen.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the mixing body is configured such that the first fluid flows into the second lumen through the plurality of openings, thereby forming a combination of the first fluid and the second fluid within the second lumen.
Osborne discloses mixing by flowing from the inner lumen to the outer lumen, but to the extent Osborne does not expressly disclose flowing from the outer lumen (first fluid) into the inner lumen (second lumen), Zurecki fills this gap by disclosing fluid flow from an annular space into an inner conduit through openings. Specifically, Zurecki discloses: “the throttling gas is introduced into one or both ends of the annular space defined by concentric tubes, while cryogenic liquid is introduced into the annular space through a series of openings in the inner tube”. (Zurecki ¶ [0057].)
Motivation to combine.
It would have been obvious to combine the base combination of Osborne and Preissman with Zurecki because flow direction across the openings can be reversed depending on relative pressures. A person of ordinary skill in the art would have been motivated to configure the system to flow fluid from the outer lumen into the inner lumen to utilize the inner lumen as the primary mixing chamber and delivery nozzle.
In relation to claim 15, this claim depends from claim 1 and further recites: the medical device of claim 1, wherein the mixing body is configured such that a gas passes through the plurality of openings so as to form a combination of a gas and a liquid.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the mixing body is configured such that a gas passes through the plurality of openings so as to form a combination of a gas and a liquid.
Osborne discloses mixing two liquid reagents, but to the extent Osborne does not expressly disclose a gas passing through the openings to combine with a liquid, Zurecki fills this gap by disclosing a gas and liquid mixing through openings in a concentric tube arrangement. Specifically, Zurecki discloses: “the cryogenic liquid and the throttling gas are introduced into a contact zone where they are contacted to form a resulting fluid.” (Zurecki ¶ [0011].)
Motivation to combine.
It would have been obvious to combine the base combination of Osborne and Preissman with Zurecki because mixing gas and liquid is useful for atomization or nebulization. A person of ordinary skill in the art would have been motivated to incorporate Zurecki’s teaching of passing gas through openings to mix with a liquid into the base system to create a dispersed spray or aerosol of the liquid agent.
In relation to independent claim 16, this claim recites: a medical device comprising: a first body defining a first lumen; and a second body disposed within the first lumen, wherein the second body defines a second lumen, and wherein a radially outer surface of the second body has a plurality of openings, such that the first lumen and the second lumen are in fluid communication via the plurality of openings; wherein the medical device is configured such that a gas passes through the plurality of openings (a) from the first lumen into the second lumen or (b) from the second lumen into the first lumen, in order to form a combination of the gas and a liquid.
A medical device comprising: a first body defining a first lumen;
Osborne discloses a medical device comprising a first body defining a first lumen. Specifically, Osborne discloses: “[m]ulti-lumen mixing device 130 generally includes an elongate element 140, for example a needle or catheter, defining lumen 142”. (Osborne ¶ [0022].)
and a second body disposed within the first lumen, wherein the second body defines a second lumen;
Osborne discloses a second body disposed within the first lumen, wherein the second body defines a second lumen. Specifically, Osborne discloses: “cannula 150 defining lumen 152” and “[c]annula support 136 supports and secures cannula 150 within elongate element 140”. (Osborne ¶ [0022].)
and wherein a radially outer surface of the second body has a plurality of openings, such that the first lumen and the second lumen are in fluid communication via the plurality of openings;
Osborne discloses wherein a radially outer surface of the second body has openings, such that the first lumen and the second lumen are in fluid communication. Specifically, Osborne discloses: “[p]orts 155 and 156 provide access between lumen 152 and lumen 142”. (Osborne ¶ [0025].) To the extent Osborne does not expressly disclose a “plurality of openings”, Preissman fills this gap by disclosing a plurality of openings. Specifically, Preissman discloses: “the combining step is carried out by flowing the second component through a plurality of openings into the first lumen.” (Preissman; claim 12.)
wherein the medical device is configured such that a gas passes through the plurality of openings (a) from the first lumen into the second lumen or (b) from the second lumen into the first lumen, in order to form a combination of the gas and a liquid.
Osborne discloses mixing fluids through the openings, but to the extent Osborne does not expressly disclose a gas passing through the openings to combine with a liquid, Zurecki fills this gap by disclosing gas passing through openings to mix with a liquid in a concentric tube arrangement. Specifically, Zurecki discloses: “the throttling gas is introduced into one or both ends of the annular space defined by concentric tubes, while cryogenic liquid is introduced into the annular space through a series of openings in the inner tube”. (Zurecki ¶ [0057].)
Motivation to combine.
It would have been obvious to combine Osborne, Preissman, and Zurecki because all these references relate to multi-lumen mixing devices. A person of ordinary skill in the art would have been motivated to incorporate Preissman’s plurality of openings and Zurecki’s gas/liquid mixing into Osborne’s coaxial system to provide a device capable of efficiently dispersing a liquid therapeutic agent into a gaseous stream for aerosolized delivery.
In relation to claim 17, this claim depends from claim 16 and further recites: the medical device of claim 16, wherein the first lumen is coaxial with the second lumen.
Base rejection incorporated.
The rejection of claim 16 is incorporated herein.
wherein the first lumen is coaxial with the second lumen.
Osborne discloses wherein the first lumen is coaxial with the second lumen. Specifically, Osborne discloses: “a cannula defining the first lumen and passing through the second lumen in a co-axial relationship.” (Osborne; claim 5.)
Motivation to combine.
It would have been obvious to combine the base combination of Osborne, Preissman, and Zurecki because a coaxial arrangement provides for a compact device profile. A person of ordinary skill in the art would have been motivated to use a coaxial lumen arrangement to minimize the overall outer diameter of the medical device while maintaining two distinct fluid paths.
In relation claim 18, this claim depends from claim 17 and further recites: the medical device of claim 17, wherein the first body is tubular, and wherein the second body is tubular.
Base rejection incorporated.
The rejection of claim 17 is incorporated herein.
wherein the first body is tubular, and wherein the second body is tubular.
Osborne discloses wherein the first body is tubular and the second body is tubular. Specifically, Osborne discloses: “elongate element 140, for example a needle or catheter” and “[c]annula 150 is formed from a metallic tube”. (Osborne ¶ [0022], [0032].)
Motivation to combine.
It would have been obvious to combine the base combination of Osborne, Preissman, and Zurecki because forming the bodies as tubes provides structural rigidity and defines clear fluid lumens. A person of ordinary skill in the art would have been motivated to use tubular bodies to reliably define the coaxial arrangement and support the mixing ports.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Osborne et al. (US 2011/0106054A1; hereinafter “Osborne”) in view of Preissman et al. (US 5,833,652A1; hereinafter “Preissman”), as discussed above, and in further view of Zurecki et al. (US2008/0048047A1; hereinafter “Zurecki”) and Baran (US 6,729,334B1).
In relation to claim 19, this claim recites: a medical method, comprising: receiving a gas in a first lumen of a medical device; receiving a liquid in a second lumen of the medical device; passing the gas through a plurality of openings in a wall between the first lumen and the second lumen so that the gas combines with the liquid to form a combination of the gas and the liquid; and delivering the combination of the gas and the liquid to a location within a body lumen of a subject.
A medical method, comprising: receiving a gas in a first lumen of a medical device; receiving a liquid in a second lumen of the medical device;
Osborne discloses receiving fluids in first and second lumens of a medical device, but to the extent Osborne does not expressly disclose receiving a gas in a first lumen and a liquid in a second lumen, Zurecki fills this gap by disclosing gas in an outer lumen and liquid in an inner lumen. Specifically, Zurecki discloses: “the throttling gas G1 is introduced into the annular space” and “the cryogenic liquid L1 is introduced into the inner conduit”. (Zurecki ¶ [0094], [0095].)
passing the gas through a plurality of openings in a wall between the first lumen and the second lumen so that the gas combines with the liquid to form a combination of the gas and the liquid;
Osborne discloses fluids passing through ports between lumens to combine, and Preissman discloses flowing through a plurality of openings. Specifically, Preissman discloses: “the combining step is carried out by flowing the second component through a plurality of openings into the first lumen.” (Preissman; claim 12.) Zurecki discloses gas passing through openings to combine with liquid. Specifically, Zurecki discloses: “the cryogenic liquid and the throttling gas are introduced into a contact zone where they are contacted to form a resulting fluid.” (Zurecki ¶ [0011].)
and delivering the combination of the gas and the liquid to a location within a body lumen of a subject.
Osborne discloses delivering combined reagents to a patient, but to the extent Osborne does not expressly disclose delivering the gas and liquid combination to a location within a body lumen, Baran fills this gap by disclosing delivering a nebulized gas and liquid combination to a body lumen (respiratory system). Specifically, Baran discloses: “A nebulization catheter is positioned in the patient’s respiratory system so that a distal end of the nebulization catheter is in the respiratory system” and “The nebulized medicine is conveyed to the patient’s lungs”. (Baran; Abstract.)
Motivation to combine.
It would have been obvious to combine Osborne, Preissman, Zurecki, and Baran because all these references relate to medical devices for delivering mixed or atomized fluids. A person of ordinary skill in the art would have been motivated to incorporate Zurecki’s gas/liquid mixing and Baran’s method of delivering an aerosolized combination to a body lumen into Osborne’s coaxial catheter system to provide an effective method for applying a dispersed liquid therapeutic agent to internal tissue surfaces.
In relation to claim 20, this depends from claim 19 and further recites: the medical method of claim 19, wherein the passing the gas through the plurality of openings disperses the liquid.
Base rejection incorporated.
The rejection of claim 19 is incorporated herein.
wherein the passing the gas through the plurality of openings disperses the liquid.
Zurecki discloses passing gas through openings to disperse liquid. Specifically, Zurecki discloses: “the cryogenic liquid is dispersed into the annular space through the plurality of openings contained in the wall of the inner conduit”. (Zurecki ¶ [0096].) Baran also discloses gas dispersing liquid. Specifically, Baran discloses: “The distal opening 36 of the pressurized gas lumen 34 directs pressurized gas across the distal liquid lumen opening 35 thereby nebulizing the liquid medication”. (Baran col. 7, lines 8-10.)
Motivation to combine.
It would have been obvious to combine the base combination of Osborne, Preissman, Zurecki, and Baran because the physical interaction of pressurized gas and liquid naturally causes dispersion or nebulization. A person of ordinary skill in the art would have been motivated to utilize the gas passing through the openings to disperse the liquid in order to create a fine mist or aerosol that can evenly coat the target tissue in the body lumen.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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