DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed February 24th, 2026 has been entered.
Response to Arguments
Applicant’s arguments, see pages 10 & 12, filed February 24th, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 and claim 73 under 35 U.S.C. 102 have been fully considered and are persuasive in view of the amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the other current prior art of record that teaches the newly disclosed claim limitations.
Regarding Applicant’s arguments on page 11 that Mulcahey appears to show and describe that a purging fluid nozzle is directed towards an inside of a cap and not radially out, the Examiner agrees that this embodiment of Mulcahey does show this, however, this embodiment is not relied upon in the rejection of claim 73 over Mulcahey to teach the claims’ limitation. Applicant argues similarly for claim 1 on page 12 but the reasons set forth above apply for claim 1, too.
Therefore, these arguments are not persuasive and the Examiner maintains that the current prior art of record teaches the original and amended claims’ limitations.
Claim Objections
Claim 1 objected to because of the following informalities:
Claim 1, line 22: “optics” should read --optics assembly--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 70 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 70, the claim recites “a working channel of an endoscope” in lines 3-4 and it is unclear if this is the same working channel or endoscope or a different working channel/endoscope from that recited in claim 1, from which claim 70 depends. For examination purposes, these are the same endoscopes and the limitation will be interpreted as “the working channel of the endoscope”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 84 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mulcahey et al. (U.S. Pub. No. 2017/0311789, previously cited), herein referred to as “Mulcahey”.
Regarding claim 84, Mulcahey discloses a cryotherapy system (cryosurgery system 100, Figs. 1A/B, 9, 10, 11A/B, 12, 25; [0123]: the features of the various embodiments described herein were not mutually exclusive and can exist in various combinations and permutations), comprising:
an optics assembly (lens 110) configured to visualize a field of view (FOV) between said optics assembly and a distally located target region inside a body lumen (Abstract: Gas, as an example, directed across and toward the lens purges moisture to avoid condensation on the lens and shears debris and bodily fluids away from the field of view; [0003]: The primary purpose of an endoscope, video or fiber optic, is to provide visualization of anatomical lumens; see Fig. 1A for the location of lens 110: it is distally facing such that the target tissue would be distally located);
an elongated cryotherapy device (catheter 1201, Fig. 12) having a long axis (see Fig. 12), a proximal end ([0105]: a hub 1203 for attachment to the console at its proximal end) and a distal end (distal end 1210) shaped and sized to be positioned inside said body lumen ([0108]: catheter insertion or manipulation into the body cavities), comprising:
a cryo inflow channel (cryogen flow channel within delivery apparatus 128, Fig. 9) within said elongated cryotherapy device (see Fig. 9: “To patient airway via bronchoscope through patient nose or mouth”; [0105]: catheter 1201 designed to transport liquid nitrogen (or other cryogen) from the console to the patient treatment site … laser cut hypotube 1205 to minimize kinking and breaking … to seal the fluid flow), fluidically connecting a cryogenic fluid source (cryogen storage tank 126, Fig. 10) with at least one cryo opening at said distal end of said elongated cryotherapy device configured to direct a cryogenic fluid flow to said target region within said body lumen, wherein said cryo inflow channel is configured to allow cryogenic fluid flow from said cryogenic fluid source towards said target region within said body lumen ([0108]: a distal tip of the catheter may contain radial spray pattern holes which make up the nozzles configured to deliver cryogen spray onto target tissue; the fluidic connectivity exists as to enable cryogen spray from the tank to the body see Fig. 18A, for the direction of cryogenic fluid to a target region);
a washing inflow channel (purging fluid supply mechanism 106) within said elongated cryotherapy device and attached to said cryo inflow channel ([0014]: A lens clearing flow field adjustment mechanism may receive a purging fluid from a purging fluid supply mechanism integrated with an endoscope … A purging fluid supply mechanism may be an outer lumen of a multilumen sheath, wherein an endoscope is provided in an inner lumen of the multilumen sheath and a purging fluid is supplied to a cap via the outer lumen; where an inner & outer lumen configuration is seen as attached to), fluidically connecting a washing fluid source ([0061]: the fluid supply line may be connected to disposable canisters of purging fluid) with at least one washing opening (lens clearing nozzle 104 & nozzle 118; [0056]: A visualization system may utilize zero or more lens clearing nozzles 104 and zero or more spatter deflection nozzles 118) configured to aim washing fluid radially out from said elongated cryotherapy device towards one or both of said optics assembly and said FOV ([0056]: lens clearing nozzle 104 directed towards the lens cover 110 … FIG. 1A depicts nozzle 118 oriented at an angle of approximately 135° from the central axis of the cap 102, such that spatter is barely diverted from impacting the scope; wherein this is seen as aiming washing fluid radially out from said elongated cryotherapy device towards one or both of sad optics assembly and/or a FOV between said optics assembly and said distally located target region inside said body lumen), wherein said cryo inflow channel is positioned within said washing inflow channel ([0012]: An endoscope may slide into an inner lumen of the multilumen sheath and the purging fluid may be supplied to a lens clearing nozzle via the outer lumen; where in this configuration, the cryo inflow path would be coaxial with the washing inflow path), and is fixedly coupled to said cryo inflow channel ([0014]: A purging fluid supply mechanism may be affixed to the endoscope) and wherein a portion of said elongated cryotherapy device comprising said at least one washing opening and said at least one cryo opening is configured to move in said body lumen outside an endoscope or a sheath, and relative to said endoscope or said sheath (wherein absent a positive recitation claiming the endoscope within the system, the claimed invention only needs to be capable of comprising " a portion of said elongated cryotherapy device comprising said at least one washing opening and said at least one cryo opening is configured to move in said body lumen outside an endoscope or a sheath, and relative to said endoscope or said sheath " such that Mulcahey's disclosed catheter 1201 is capable to move in said body lumen outside said endoscope or said sheath, and relative to said endoscope or said sheath; sleeve 126, see Fig. 1A where the cryo inflow channel and washing inflow channel are capable of moving together within the body as sleeve 126 surrounds them & is outside of both).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, 5-6, 9-10, 12, 14, 59, 62-63, 65-71, 75, 80 & 83 are rejected under 35 U.S.C. 103 as being unpatentable over Mulcahey in view of Burr et al. (U.S. Pub. No. 20130253491, previously cited), herein referred to as “Burr” and Caplan et al. (U.S. Pub. No. 20150148738, previously cited), herein referred to as “Caplan”.
Regarding claim 1, Mulcahey discloses a cryotherapy system (cryosurgery system 100, Figs. 1A/B, 9, 10, 11A/B, 12, 25; [0123]: the features of the various embodiments described herein were not mutually exclusive and can exist in various combinations and permutations), wherein said cryotherapy system comprising:
an elongated cryotherapy device (catheter 1201, Fig. 12) having a long axis (longitudinal axis of catheter 1201 in Fig. 12), a proximal end ([0105]: a hub 1203 for attachment to the console at its proximal end) and a distal end (distal end 1210) shaped and sized to be positioned inside a body lumen ([0108]: catheter insertion or manipulation into the body cavities), comprising:
a cryo inflow path (delivery apparatus 128, Fig. 9) within said elongated cryotherapy device (see Fig. 9: “To patient airway via bronchoscope through patient nose or mouth”; [0105]: catheter 1201 designed to transport liquid nitrogen (or other cryogen) from the console to the patient treatment site … laser cut hypotube 1205 to minimize kinking and breaking … to seal the fluid flow) fluidically connecting a cryogenic fluid source (cryogen storage tank 126, Fig. 10),
a washing inflow path (purging fluid supply mechanism 106) within said elongated cryotherapy device and attached to said cryo inflow path ([0014]: A lens clearing flow field adjustment mechanism may receive a purging fluid from a purging fluid supply mechanism integrated with an endoscope … A purging fluid supply mechanism may be an outer lumen of a multilumen sheath, wherein an endoscope is provided in an inner lumen of the multilumen sheath and a purging fluid is supplied to a cap via the outer lumen; where an inner & outer lumen configuration is seen as attached to) fluidically connecting a washing fluid source ([0061]: the fluid supply line may be connected to disposable canisters of purging fluid) with a plurality of sideways washing openings at said distal end of said elongated cryotherapy device (lens clearing nozzle 104 & nozzle 118; [0056]: A visualization system may utilize zero or more lens clearing nozzles 104; see Fig. 1A where lens clearing nozzle 104 is sideways (i.e. not positioned/oriented in the distal direction) and is at a distal end of the cryotherapy device) and disposed proximal to a distal end of said washing inflow path in a side surface (shrouding portion 116) of said washing inflow path ([0056]: a lens clearing flow field adjustment mechanism that includes two nozzles: a lens clearing nozzle 104 directed towards the lens cover 110 of endoscope 112, and a spatter deflection nozzle 118; where 118 and 104 are both part of the washing inflow path and nozzle 104 is proximal to a distal end (nozzle 118) of the washing inflow path & is on a side surface of said washing inflow path) and wherein said sideways washing openings are configured to aim washing fluid radially out from said elongated cryotherapy device to clear a field of view (FOV) between said optics and said distally located target region ([0056]: lens clearing nozzle 104 directed towards the lens cover 110 … FIG. 1A depicts nozzle 118 oriented at an angle of approximately 135° from the central axis of the cap 102, such that spatter is barely diverted from impacting the scope; [0010]: Guides may also direct and induce turbulent flow distally to the cap and distal end of the endoscope, such as, for example, in a distal vortex to further clear or keep clear the viewing area of obstructions; see Figs. 1A/B where the nozzles 104 & 118 are shown as being positioned such that they induce fluid flow in a radial/sideways direction vs fluid flow along the longitudinal axis),
while Mulcahey discloses a cryo inflow path configured to direct a cryogenic fluid flow to a target region within said body lumen located distally to said distal end of said elongated cryotherapy device, wherein said cryo inflow path is configured to allow cryogenic fluid flow from said cryogenic fluid source towards said target region into within said body lumen ([0108]: a distal tip of the catheter may contain radial spray pattern holes which make up the nozzles configured to deliver cryogen spray onto target tissue; see Fig. 18A);
Mulcahey fails to explicitly disclose a cryo inflow path with at least one distally facing front cryo opening of said cryo inflow path at said distal end of said elongated cryotherapy device configured to direct a cryogenic fluid flow to a target region within said body lumen located distally to said distal end of said elongated cryotherapy device and distally to said at least one distally facing front cryo opening, wherein said cryo inflow path is configured to allow cryogenic fluid flow from said cryogenic fluid source towards said target region into within said body lumen.
However, Burr discloses a cryo inflow path with at least one distally facing front cryo opening (hole 276) of said cryo inflow path at said distal end of said elongated cryotherapy device configured to direct a cryogenic fluid flow to a target region within said body lumen located distally to said distal end of said elongated cryotherapy device and distally to said at least one distally facing front cryo opening, wherein said cryo inflow path is configured to allow cryogenic fluid flow from said cryogenic fluid source towards said target region into within said body lumen ([0083]: the hole at the distal end of the catheter 276 for straight spray; see Fig. 18 where this distally facing opening directs cryogen to a target region located distally to the distal end of the device & the opening). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the cryo inflow path of Mulcahey to have the distally facing front opening of Burr for the purpose of the opening allowing for a specific spray pattern, specifically a straight spray with this distally facing opening (Burr: [0083]).
While Mulcahey’s device is capable of being shaped and sized to move within a working channel of an endoscope, Mulcahey fails to explicitly disclose the cryotherapy system shaped and sized to move within a working channel of an endoscope, said endoscope includes an optics assembly, wherein said distal end of said elongated cryotherapy device comprising said at least one distally facing front cryo opening and said plurality of sideways washing openings is shaped and sized to be introduced via an endoscope into said body lumen and to move outside said endoscope in said body lumen, relative to said endoscope.
However, Caplan discloses the cryotherapy system ([0120]: Expandable assembly 130 can be configured to seal a body lumen location … System 10 can be configured to cause a fluid or other seal comprising a seal selected from the group consisting of: … a cryogenically applied seal such as an ice ball seal) shaped and sized to move within a working channel of an endoscope (endoscope 350; [0106]: In FIG. 1, shafts 111a and 111b have been inserted through a working channel (e.g. a 6 mm working channel), lumen 351, of endoscope 350), said endoscope includes an optics assembly (camera 352), wherein said distal end of said elongated cryotherapy device comprising said at least one distally facing front cryo opening ([0163]: The cooling fluid can be delivered through functional element 138 of expandable assembly 130 and/or functional element 148 of fluid delivery assembly 140, such as when functional elements 138 and/or 148 comprises a fluid delivery element such as a nozzle) and said plurality of sideways washing openings ([0123]: Nozzle 145' can be used to perform various functions such as the washing or removing of material from a device 100 component) is shaped and sized to be introduced via an endoscope into said body lumen and to move outside said endoscope in said body lumen, relative to said endoscope ([0106]: Shafts 111a and 111b are sized and configured such that shaft 111a slidingly receives shaft 111b, such that they can be advanced and/or retracted in unison or independently; [0166]: motion transfer assembly 320 is configured to rotate and/or axially translate shafts 111a and/or 111b such that fluid delivery assembly 140 and/or expandable assembly 130, respectively, are rotated and/or translated).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the cryotherapy system of Mulcahey in view of Burr to be shaped and sized to move within a working channel of an endoscope, as taught by Caplan, for the purpose of the endoscope providing direct visualization of internal body spaces and tissue and the motion enabling advancing and/or retracting fluid delivery assembly and/or expandable assembly from a first position to treat a first portion of target tissue, to a second position to treat a second portion of target tissue (Caplan: [0141], [0166]).
Regarding claim 3, Mulcahey discloses at least one washing flow regulator that is configured to control washing fluid flow through said washing inflow path ([0061]: A mass flow or other suitable controller may be used to regulate and/or vary a flow rate of purging fluid during operation).
Regarding claim 5, Mulcahey discloses at least one purge flow regulator on said cryo inflow path that is configured to control non-cryogenic fluid flow through said cryo inflow path (see the flow chart Fig. 11A where GN2 (gaseous nitrogen, the non-cryogenic fluid) is directed to be on the same path as LN2 (liquid nitrogen, the cryo fluid) at manifold 196 and to catheter interface 193 such that it follows the same path) when said cryogenic flow from said cryogenic fluid source is reduced ([0104]: a defrost function is useful for thawing a catheter after cryogen spray (when said cryogenic flow from said cryogenic fluid flow source is reduced), before removal from the endoscope. In the example of Figs. 11A and 11B, a defrost circuit directs (the purge flow regulator) gaseous nitrogen (non-cryogenic fluid) from the top of the tank through a heater 187 and frost valve 190 to the catheter 128; where catheter 128 also contains the cryo inflow path).
Regarding claim 6, Mulcahey discloses wherein said elongated cryotherapy device comprises at least one outflow path (egress channel 2508) configured to evacuate cryogenic fluid and/or washing fluid from a distal opening at said distal end towards a proximal opening of said elongated cryotherapy device ([0086]: the egress channel 2508 may be connected at a proximal end to an active suction mechanism to draw the purging fluid from the channel 2506, across the lens 2510, and into gas egress channel 2508); and
at least one outflow regulator ([0086]: active suction mechanism) on said outflow path configured to control said cryogenic fluid and/or said washing fluid evacuation from said body lumen through said at least one outflow path (where an active suction mechanism differs from a passive venting mechanism such that it is the controlled evacuation of matter rather than the ambient movement of excess fluids/gas).
Regarding claim 9, Mulcahey discloses a control circuitry and at least one pressure sensor connected to said control circuitry, configured to measure said body lumen pressure or changes in said body lumen pressure, and wherein said control circuitry is configured to control said cryogenic fluid flow within said cryo inflow path and/or said washing inflow path, based on said at least one pressure sensor measurements ([0061]: a mass flow or other suitable controller (control circuitry) may be used to regulate and/or vary a flow rate of purging fluid during operation (control of flow within the washing inflow path). Pressure feedback (from an implied pressure sensor) from the supply line or taken within a body lumen (measured body lumen pressure), or both, may be utilized to reduce a risk of distension or pneumothorax), (Where “and/or” is being interpreted as “or” and therefore only control of flow within said cryo inflow path or said washing inflow path needs to be taught by the prior art).
Regarding claim 10, Mulcahey discloses a control circuitry and at least one temperature sensor connected to said control circuitry, configured to measure temperature levels and/or temperature changes inside said body lumen, and wherein said control circuitry is configured to control said cryogenic fluid flow through said cryo inflow path and/or is configured to control said washing inflow path into said body lumen, based on said at least one temperature sensor ([0102]: a data acquisition board (control circuitry) collects data from a thermocouple 195 (temperature sensor, connectivity is implied to be able to collect/transmit/analyze data). The system software monitors data from the thermocouple 195, and opens the cryogen valve 186 to cool the manifold 196 when its temperature is above the desired set-point (control circuitry controls the flow of said cryogenic fluid based on said measured temperature values)) (Where “and/or” is being interpreted as “or” and therefore only measuring temperature levels or temperature changes inside said body lumen (first occurrence) and the flow of said cryogenic fluid through said cryo inflow path or controls said washing inflow path into said body lumen (second occurrence) needs to be taught by the prior art).
Regarding claim 12, Mulcahey discloses wherein at least one of said plurality of sideways washing openings is configured to direct said washing fluid towards said field of view and away from said optics assembly ([0056]: a spatter deflection nozzle 118 directed out and away from the lens 110 at an angle with respect to a central axis of the cap, for deflecting incoming spatter, particulates, and fog).
Regarding claim 14, Mulcahey discloses wherein at least one of said plurality of sideways washing opening is configured to direct said washing fluid towards said optics assembly ([0056]: lens clearing nozzle 104 directed towards the lens cover 110).
Regarding claim 59, Mulcahey discloses wherein said target region is at an internal surface of said body lumen (Abstract: body cavity or lumen being treated; [0108]: deliver cryogen spray onto target tissue; any treatment for body lumens will be to an internal surface), and wherein said cryotherapy system is used for ablating tissue at said target region ([0108]: deliver cryogen spray onto target tissue; where any cryotherapy is a form of ablation capable of removing tissue from a target area).
Regarding claim 62, Mulcahey in view of Caplan discloses wherein said optics assembly comprises at least one lens (Caplan: camera 352) and/or at least one illumination source (where “and/or” is being interpreted as “or” and therefore only a lens or a at least one illumination source needs to be taught by the prior art).
Regarding claim 63, Mulcahey discloses wherein said washing inflow path comprises (purging fluid supply mechanism 106) at least one front washing opening (spatter deflection nozzle 118) at said elongated cryotherapy device distal end (see Fig. 1A where spatter deflection nozzle 118 is positioned on the device’s distal end).
Regarding claim 65, Mulcahey discloses wherein said body lumen comprises a cervix, a prostate, a urethra, a ureter, a stomach or a uterus (Abstract: the body cavity or lumen being treated; [0007]: a flexible endoscope (e.g. a gastroscope); where a gastroscope is shaped and sized to be positioned inside a stomach).
Regarding claim 66, Mulcahey discloses a control unit connected to said elongated cryotherapy device ([0089]: embodiments of the visualization system, e.g., systems for use with cryospray catheters, may incorporate a temperature control system, such as an active heater or a passive catheter vacuum jacket), comprising a control circuitry (flexible printed circuit 702);
at least one washing flow regulator on said washing inflow path, connected to said control circuitry (Abstract: The cap or shroud assembly incorporates a lens clearing flow field adjustment mechanism, such as nozzles, designed to direct warm (room temperature or higher) purging fluid across a lens at the scope tip; [0090]: flexible printed circuit may electrically heat an endoscope and/or the purging fluid supply mechanism to avoid condensation/freezing temperatures. A flexible printed circuit may run along the length of the endoscope, as shown, and/or along the purging fluid supply mechanism, such that purging fluid is adequately heated when it reaches the cap; [0061]: A mass flow or other suitable controller may be used to regulate and/or vary a flow rate of purging fluid during operation; where the connection between the two systems is implied to enable the fluid to be heated before reaching the cap such that it must take flow rate into account to ensure adequate heating of the purging fluid); wherein said at least one washing flow regulator is configured to control washing fluid flow through said washing inflow path in response to a signal from said control circuitry ([0089]: The heating element may maintain safe exposure temperatures in a patient, while maintaining the lens temperature above the dew point; [0062]: A purging fluid may be supplied continuously to the nozzles or other lens clearing flow field adjustment mechanisms of the visualization system, or a fluid supply may be valved or metered so that the purging fluid flows on an as-needed basis. In some embodiments, a button or switch may be provided that allows the flow of the purging fluid to be temporarily increased, in order to perform touch-up jobs or provide a bolus of purging fluid in the event that visualization becomes impaired despite the normal operation of the visualization system; wherein the maintenance of a safe exposure temperature would have to take in to account fluid flow such that fluid flow would be a controlled factor in addition to temperature control).
Regarding claim 67, Mulcahey discloses wherein said control circuitry is configured to control said washing flow regulator to regulate washing fluid flow into said body lumen when cryogenic flow is stopped ([0013]: may include heating elements, such as one or more flexible printed circuits, that electrically heat the endoscope, lens, and/or the purging fluid supply mechanism to avoid condensation/freezing temperatures. The devices of the system may be heat treated before, during, or in between treatments; wherein “between treatments” is such that cryogen flow has stopped and the use of the control circuitry to control this step is implied).
Regarding claim 68, Mulcahey discloses wherein said elongated cryotherapy device (catheter 1201) is a tubular elongated cryotherapy device ([0105]: the catheter 1201 contains a laser cut hypotube 1205, a second smaller ID laser cut hypotube 1207), and wherein said cryo inflow path and said washing inflow path are within said tubular elongated cryotherapy device (see Fig. 9: delivery apparatus 128 “To patient airway via bronchoscope through patient nose or mouth”; [0105]: catheter 1201 designed to transport liquid nitrogen (or other cryogen) from the console to the patient treatment site … laser cut hypotube 1205 to minimize kinking and breaking … to seal the fluid flow; [0014]: A lens clearing flow field adjustment mechanism may receive a purging fluid from a purging fluid supply mechanism integrated with an endoscope).
Regarding claim 69, Mulcahey discloses wherein said cryo inflow path is positioned within said washing inflow path ([0012]: An endoscope may slide into an inner lumen of the multilumen sheath and the purging fluid may be supplied to a lens clearing nozzle via the outer lumen; where in this configuration, the cryo inflow path would be coaxial with the washing inflow path).
Regarding claim 70, Mulcahey discloses wherein said elongated cryotherapy device comprising said cryo inflow path (catheter 1201, Fig. 12), said optics assembly and said washing inflow path, is shaped and sized to be introduced into said body lumen via a working channel of an endoscope ([0012]: An endoscope may slide into an inner lumen of the multilumen sheath and the purging fluid may be supplied to a lens clearing nozzle via the outer lumen; where this configuration is seen as being introduced via a working channel of an endoscope as it is known that a multilumen sheath is commonly an endoscope/this limitation does not actively claim an endoscope as part of the system since the limitation only requires that the cryotherapy device be capable of being sized and shaped to be introduced into said body lumen via a working channel of an endoscope) but Mulcahey fails to disclose wherein said elongated cryotherapy device has a maximal overall diameter in a range between 0.8 mm and 9 mm.
However, Caplan discloses wherein an elongated cryotherapy device has a maximal overall diameter in a range between 0.8 mm and 9 mm ([0011]: The elongate shaft can be configured to be passed through a working channel of an endoscope such as a 6.0 mm working channel, a 4.2 mm working channel, a 3.8 mm working channel, a 3.2 mm working channel, or a 2.8 mm working channel). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the diameter of Mulcahey in view of Burr to the diameter of Caplan for the purpose of enabling the device to be passed through a working channel of an endoscope (Caplan: [0011]).
Regarding claim 71, Mulcahey discloses wherein said plurality of sideways washing openings are openings (opening in guide 2008 that results in drain 2014b) facing away from a longitudinal axis of said cryo inflow path (see Fig. 20C where drain 2014b leads fluid away from the probe and therefore away from the cryo path).
Regarding claim 75, Mulcahey discloses wherein said plurality of sideways washing openings (lens clearing nozzle 104; [0056]: A visualization system may utilize zero or more lens clearing nozzles 104) are configured to aim said washing fluid towards said field of view to clear said field of view from particles formed by release of said cryogenic fluid flow through said at least one front cryo opening ([0056]: a lens clearing flow field adjustment mechanism that includes two nozzles: a lens clearing nozzle 104 directed towards the lens cover 110 of endoscope 112, and a spatter deflection nozzle 118; [0010]: Guides may also direct and induce turbulent flow distally to the cap and distal end of the endoscope, such as, for example, in a distal vortex to further clear or keep clear the viewing area of obstructions).
Regarding claim 80, Mulcahey discloses wherein at said distal end of said elongated cryotherapy device a washing channel defining said washing inflow path is fixedly coupled to a cryo inflow channel defining said cryo inflow path ([0014]: A purging fluid supply mechanism may be affixed to the endoscope; wherein the purging supply mechanism is indirectly fixed to the endoscope comprising the cryo inflow channel/cryo inflow path).
Regarding claim 83, Mulcahey discloses wherein said target region is located in a wall of said body lumen ([0008]: the body cavity or lumen being treated), and wherein said plurality of sideways washing openings at said distal end of said elongated cryotherapy device are configured to aim and release washing fluid towards into a volume in said FOV between said optics assembly and said target region in said body lumen wall (Abstract: Gas, as an example, directed across and toward the lens purges moisture to avoid condensation on the lens and shears debris and bodily fluids away from the field of view. Gas directed or deflected by a guide away from the lens serves the purpose of keeping incoming particles and fluid droplets (e.g. spatter) from impacting on the lens cover; [0056]: a spatter deflection nozzle 118 directed out and away from the lens 110 at an angle with respect to a central axis of the cap, for deflecting incoming spatter, particulates, and fog).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mulcahey in view of Burr and Caplan, as applied to claim 1 above, further in view of Germain et al. (U.S. Pub. No. 2014/0303551, cited in IDS), herein referred to as “Germain”.
Regarding claim 7, Mulcahey discloses an outflow regulator but fails to disclose wherein said at least one outflow regulator comprises a check valve configured to open when a pressure measured inside said body lumen is higher than a pre-determined value.
However, Germain discloses an endoscope (50, Figs. 1, 18) for tissue ablation ([0113]: the applied energy can be adapted to ablate and resect tissue) with an optics assembly (light source 136, camera 135) and fluid inflow and outflow paths (inflow/outflow channels 108a, 108b that communicate with valve-connectors 110a, 110b) with an outflow regulator and wherein said at least one outflow regulator comprises a check valve (check valve 680) configured to open when a pressure measured inside said body lumen is higher than a pre-determined value ([0097]: if intra-cavity pressure exceeds the targeted maximum level, the controller 545 provides an algorithm-based pressure relief mechanism by modulating the pumps while the check-valve 680 provides a back-up form of pressure relief). Therefore, it would have been obvious to one of ordinary skill before the effective filing date to modify the outflow regulator of Mulcahey in view of Burr and Caplan to the check valve of Germain for the purpose of providing a mechanism of over-pressure protection and pressure relief (Germain: [0097]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Mulcahey in view of Burr and Caplan, as applied to claim 1 above, further in view of Mulcahey.
Regarding claim 13, Mulcahey discloses wherein said cryotherapy device comprises at least one washing flow director, and said washing flow director comprises a nozzle and/or a deflecting surface ([0010]: Embodiments of the cap may include one or more guides that extend from or around an edge of the cap in proximity to the lens clearing flow field adjustment mechanism in order to direct, deflect, or recycle flow towards the lens and/or a drain, or away from a catheter; where “and/or” is being interpreted as “or” and therefore only a nozzle or a deflecting surface needs to be taught by the prior art) configured to generate a virtual cone
But Mulcahey fails to explicitly disclose the deflecting surface configured to generate a virtual cone around said cryogenic fluid flow released from said front cryo opening by said washing fluid released from said plurality of sideways washing openings.
However, Mulcahey in an alternate embodiment, discloses a deflecting surface configured to generate a virtual cone around said cryogenic fluid flow released from said front cryo opening by said washing fluid released from said plurality of sideways washing openings ([0076]: The guide 1908 is curved and angled to guide the purging fluid generally in a distal direction with an angle of, for example, about 60° proximally from a radial axis of the cap. The guide 1908 may also deflect or recycle the fluid generally around the inside rim of the cap 1902. With gas as a purging fluid, this path can act to create a vortex in front of the cap as the gas circles distally beyond the endoscope tip 1912; where in combination with the spray as shown in Fig. 18, the vortex extending distally beyond the distal tip would create a cone around the cryogenic fluid flow shown in Fig. 18). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the deflecting surface of Mulcahey in view of Burr and Caplan with the alternate embodiment of Mulcahey for the purpose of the guide/vortex enabling the ability to clear or keep the viewing area free from obstructions (Mulcahey: [0010]: Guides may take on many shapes to create a desired path for the purging fluid, such as curves and slants. Guides may also direct and induce turbulent flow distally to the cap and distal end of the endoscope, such as, for example, in a distal vortex to further clear or keep clear the viewing area of obstructions).
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over Mulcahey in view of Burr and Caplan, as applied to claim 1 above, further in view of Burnett et al. (U.S. Pub. No. 2012/0136343, cited in IDS), herein referred to as “Burnett”.
Regarding claim 64, Mulcahey discloses wherein said body lumen comprises a body cavity or lumen (Abstract) but fails to disclose that the body lumen comprises a bladder.
However, Burnett discloses a cryotherapy device (endoscope/cystoscope 12, Figs. 4, 8A-C; where a cystoscope is shaped and sized to be positioned inside a bladder) with an inflow channel ([0044]: the thermal (or cooling) energy may be applied to the internal surface of the lumen or body cavity; via annular lumen 70) with an optics assembly ([0007]: endoscope or other visualization device allowing the therapy to be delivered under direct visualization; where most devices with the suffix “-scope” include visualization means) and wherein said body lumen comprises a bladder ([0043]: FIGS. 8A to 8C illustrate another example for treatment (here shown as the bladder)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date to modify the treatment body lumen of Mulcahey in view of Burr and Caplan to the bladder disclosed in Burnett for the purpose of enabling treatment of an enclosed body cavity so that the entire cavity may see a controlled, uniform thermal treatment (Burnett: [0042], [0043]).
Claims 73-74 are rejected under 35 U.S.C. 103 as being unpatentable over Mulcahey in view of Caplan.
Regarding claim 73, Mulcahey discloses a cryotherapy system (cryosurgery system 100, Figs. 1A/B, 9, 10, 11A/B, 12, 25; [0123]: the features of the various embodiments described herein were not mutually exclusive and can exist in various combinations and permutations), wherein said cryotherapy system comprising:
an elongated cryotherapy device (catheter 1201, Fig. 12) having a long axis (see Fig. 12), a proximal end ([0105]: a hub 1203 for attachment to the console at its proximal end) and a distal end (distal end 1210) shaped and sized to be positioned inside a body lumen ([0108]: catheter insertion or manipulation into the body cavities), comprising:
a cryo inflow channel (cryogen flow channel within delivery apparatus 128, Fig. 9) within said elongated cryotherapy device (see Fig. 9: “To patient airway via bronchoscope through patient nose or mouth”; [0105]: catheter 1201 designed to transport liquid nitrogen (or other cryogen) from the console to the patient treatment site … laser cut hypotube 1205 to minimize kinking and breaking … to seal the fluid flow), fluidically connecting a cryogenic fluid source (cryogen storage tank 126, Fig. 10) with at least one front cryo opening at said distal end of said elongated cryotherapy device configured to direct a cryogenic fluid flow to a target region within said body lumen, wherein said cryo inflow channel is configured to allow cryogenic fluid flow from said cryogenic fluid source towards said target region within said body lumen ([0108]: a distal tip of the catheter may contain radial spray pattern holes which make up the nozzles configured to deliver cryogen spray onto target tissue; the fluidic connectivity exists as to enable cryogen spray from the tank to the body see Fig. 18A, for the direction of cryogenic fluid to a target region);
a washing inflow channel (purging fluid supply mechanism 106) within said elongated cryotherapy device and attached to said cryo inflow channel ([0014]: A lens clearing flow field adjustment mechanism may receive a purging fluid from a purging fluid supply mechanism integrated with an endoscope … A purging fluid supply mechanism may be an outer lumen of a multilumen sheath, wherein an endoscope is provided in an inner lumen of the multilumen sheath and a purging fluid is supplied to a cap via the outer lumen; where an inner & outer lumen configuration is seen as attached to), fluidically connecting a washing fluid source ([0061]: the fluid supply line may be connected to disposable canisters of purging fluid) with at least one washing opening (lens clearing nozzle 104 & nozzle 118; [0056]: A visualization system may utilize zero or more lens clearing nozzles 104 and zero or more spatter deflection nozzles 118) configured to aim washing fluid radially out from said elongated cryotherapy device towards one or both of said optics assembly and/or a field of view (FOV) between said optics assembly and said distally located target region inside said body lumen ([0056]: lens clearing nozzle 104 directed towards the lens cover 110 … FIG. 1A depicts nozzle 118 oriented at an angle of approximately 135° from the central axis of the cap 102, such that spatter is barely diverted from impacting the scope; wherein this is seen as aiming washing fluid radially out from said elongated cryotherapy device towards one or both of sad optics assembly and/or a FOV between said optics assembly and said distally located target region inside said body lumen), wherein said cryo inflow channel is positioned within said washing inflow channel ([0012]: An endoscope may slide into an inner lumen of the multilumen sheath and the purging fluid may be supplied to a lens clearing nozzle via the outer lumen; where in this configuration, the cryo inflow path would be coaxial with the washing inflow path), and is fixedly coupled to said cryo inflow channel ([0014]: A purging fluid supply mechanism may be affixed to the endoscope).
While Mulcahey’s device is capable of being shaped and sized to move within a working channel of an endoscope, Mulcahey fails to explicitly disclose the cryotherapy system, shaped and sized to move within a working channel of an endoscope, said endoscope includes an optics assembly and wherein a portion of said elongated cryotherapy device comprising said at least one washing opening and said at least one cryo opening is configured to move in said body lumen outside said endoscope, and relative to said endoscope.
However, Caplan discloses the cryotherapy system ([0120]: Expandable assembly 130 can be configured to seal a body lumen location … System 10 can be configured to cause a fluid or other seal comprising a seal selected from the group consisting of: … a cryogenically applied seal such as an ice ball seal), shaped and sized to move within a working channel of an endoscope (endoscope 350; [0106]: In FIG. 1, shafts 111a and 111b have been inserted through a working channel (e.g. a 6 mm working channel), lumen 351, of endoscope 350), said endoscope includes an optics assembly (camera 352) and wherein a portion of said elongated cryotherapy device comprising said at least one washing opening ([0123]: Nozzle 145' can be used to perform various functions such as the washing or removing of material from a device 100 component) and said at least one cryo opening ([0163]: The cooling fluid can be delivered through functional element 138 of expandable assembly 130 and/or functional element 148 of fluid delivery assembly 140, such as when functional elements 138 and/or 148 comprises a fluid delivery element such as a nozzle) is configured to move in said body lumen outside said endoscope, and relative to said endoscope ([0106]: Shafts 111a and 111b are sized and configured such that shaft 111a slidingly receives shaft 111b, such that they can be advanced and/or retracted in unison or independently; [0166]: motion transfer assembly 320 is configured to rotate and/or axially translate shafts 111a and/or 111b such that fluid delivery assembly 140 and/or expandable assembly 130, respectively, are rotated and/or translated).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the cryotherapy system of Mulcahey to be shaped and sized to move within a working channel of an endoscope, as taught by Caplan, for the purpose of the endoscope providing direct visualization of internal body spaces and tissue and the motion enabling advancing and/or retracting fluid delivery assembly and/or expandable assembly from a first position to treat a first portion of target tissue, to a second position to treat a second portion of target tissue (Caplan: [0141], [0166]).
Regarding claim 74, Mulcahey fails to disclose wherein a maximal overall diameter of said elongated cryotherapy device comprising said cryo inflow channel, said optics assembly and said washing inflow channel, is in a range between 0.8 mm and 9 mm.
However, Caplan discloses wherein a maximal overall diameter of said elongated cryotherapy device comprising said cryo inflow channel, said optics assembly and said washing inflow channel, is in a range between 0.8 mm and 9 mm ([0011]: The elongate shaft can be configured to be passed through a working channel of an endoscope such as a 6.0 mm working channel, a 4.2 mm working channel, a 3.8 mm working channel, a 3.2 mm working channel, or a 2.8 mm working channel). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the diameter of Mulcahey to the diameter of Caplan for the purpose of enabling the device to be passed through a working channel of an endoscope (Caplan: [0011]).
Claims 77-79 are rejected under 35 U.S.C. 103 as being unpatentable over Mulcahey in view of Burr and Caplan, as applied to claim 1 above, further in view of Burt.
Regarding claim 77, Mulcahey in view of Burr and Caplan fails to disclose wherein at said distal end of said elongated cryotherapy device a washing channel defining said washing inflow path directly contacts a wall of a cryo inflow channel defining said cryo inflow path.
However, Burt discloses wherein at said distal end (distal end 108) of said elongated cryotherapy device (trocar 100) a washing channel (channel 116) defining said washing inflow path ([0038]: liquid outlet(s) 106 can have a shape and/or size sufficient to generate sufficient liquid flow to reach the center of the central cylinder 102 and clean a lens of an endoscope) directly contacts a wall of a cryo inflow channel (central channel 103) defining said cryo inflow path (wherein this path is capable of allowing for fluid flow). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the channel configuration of Mulcahey in view of Burr and Caplan to the washing channel defining said washing inflow path directly contacts a wall of a cryo inflow channel, as taught by Burt for the purpose of the expanded cross-sectional surface area of fluid channel (the washing inflow channel) lowers the friction applied to the fluid within the channel (washing inflow channel) (Burt: [0047]).
Regarding claim 78, Mulcahey discloses wherein said side surface (shrouding portion 116) of said washing inflow path comprising said plurality of sideways washing openings, extends along said elongated cryotherapy device long axis and surrounds an inner lumen of said washing inflow path (see Fig. 1A where the shrouding portion 116 extends along the longitudinal axis and surrounds an inner lumen of the washing path since the washing path flows within the shrouding portion 116).
Regarding claim 79, Mulcahey in view of Burr and Caplan fails to disclose wherein said plurality of sideways washing openings are axially distributed in said side surface of said washing inflow path along said long axis.
However, Burt discloses wherein said plurality of sideways washing openings (liquid outlets 106) are axially distributed in said side surface of said washing inflow path along said long axis ([0033]: liquid outlets 106 can be arranged at various radial positions and in a single distal depth or at varying distal depths; see Fig. 1 where liquid outlets are distributed along both the axial and radial direction, where having the liquid outlets form a ring shape is still seen as along a long axis since the arrangement is located on the axis). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the sideways washing openings of Mulcahey in view of Burr and Caplan to the axial distribution as taught by Burt, for the purpose of sufficient fluid flow to reach the center of the central cylinder and clean a lens of an endoscope (Burt: [0038]).
Claims 81-82 are rejected under 35 U.S.C. 103 as being unpatentable over Mulcahey and Caplan, as applied to claim 73 above, further in view of Burr.
Regarding claim 81, Mulcahey fails to explicitly disclose wherein said at least one cryo opening comprises a at least one front cryo opening, and wherein said target region within said body lumen is located distally to said distal end of said elongated cryotherapy device.
However, Burr discloses wherein said at least one cryo opening comprises a at least one front cryo opening (hole 276), and wherein said target region within said body lumen is located distally to said distal end of said elongated cryotherapy device ([0083]: the hole at the distal end of the catheter 276 for straight spray; see Fig. 18 where this distally facing opening directs cryogen to a target region located distally to the distal end of the device & the opening). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the cryo inflow path of Mulcahey to have the distally facing front opening of Burr for the purpose of the opening allowing for a specific spray pattern, specifically a straight spray with this distally facing opening (Burr: [0083]).
Regarding claim 82, Mulcahey discloses wherein said target region is located in a wall of said body lumen ([0008]: the body cavity or lumen being treated), and wherein said at least one washing openings at said distal end of said elongated cryotherapy device is configured to aim and release washing fluid into a volume in said FOV between said optics assembly and said target region in said body lumen wall (Abstract: Gas, as an example, directed across and toward the lens purges moisture to avoid condensation on the lens and shears debris and bodily fluids away from the field of view. Gas directed or deflected by a guide away from the lens serves the purpose of keeping incoming particles and fluid droplets (e.g. spatter) from impacting on the lens cover; [0056]: a spatter deflection nozzle 118 directed out and away from the lens 110 at an angle with respect to a central axis of the cap, for deflecting incoming spatter, particulates, and fog).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
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