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 Arguments
Applicant’s arguments with respect to claim(s) 1, 17, and 20 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.
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.
Claim(s) 1-5, 14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al (US 2021/0153938) hereinafter Kang in view of Sara et al (US 2017/0135740) hereinafter Sara.
Regarding claim 1, Kang discloses an apparatus for laser treatment of gastro-esophageal reflux disease using a balloon catheter, comprising:
a light irradiation unit (optical fiber) configured to irradiate light to esophageal tissue [0063];
a balloon catheter (inflatable balloon catheter 320) including
a first balloon portion into which an optical fiber connected to the light irradiation unit is inserted ([0089] optical fiber 310 is positioned in the inflatable balloon catheter 320), and
which is expanded by fluid to expand the esophageal tissue ([0096] fluid may be supplied into the inflatable balloon catheter 320 to expand the catheter) and
is expanded to form a straight line having an angle of 0 to 90° with a movement path of the optical fiber (Fig. 4).
Kang fails to disclose a second balloon portion having an expansion region distinguished from an expansion region of the first balloon portion, and expanded to form a curved line such that a distance in a direction perpendicular to the movement path of the optical fiber increases from its portion connected to the first balloon portion; a sensor monitoring unit configured to monitor esophageal tissue sensed by a sensor provided in the balloon catheter; and a controller configured to receive measurement information from the sensor monitoring unit to control a light source of the light irradiation unit.
However, Sara discloses a balloon catheter ([0025] treatment catheter 12) including a first balloon portion ([0025] plurality of lobes 20), and
a second balloon portion having an expansion region distinguished from an expansion region of the first balloon portion ([0025] each of the balloon lobes 20 may be inflated and deflated independently of each other), and expanded to form a curved line such that a distance in a direction perpendicular to a longitudinal axis of the balloon catheter increases from its portion connected to the first balloon portion (see annotated Fig. 1);
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Annotated Fig. 1: The solid arrow points to a first balloon portion, the dashed arrow points to a second balloon portion having a distinguished expansion region that expands to form a curved line and an increased distance in a direction perpendicular to a longitudinal axis of the balloon catheter, and the circle encompasses the connected portion
a sensor monitoring unit (one or more temperature and/or pressure sensors) configured to monitor esophageal tissue sensed by a sensor provided in the balloon catheter ([0034] one or more temperature and/or pressure sensors (not shown) proximate and/or within the balloon treatment element 18 for monitoring, recording or otherwise conveying measurements of conditions within the medical device or the ambient environment at the distal portion of the medical device); and
a controller (control unit 14) configured to receive measurement information from the sensor monitoring unit to control a light source of the light irradiation unit ([0034] catheter 12 may also be used to deliver laser energy and sensor(s) may be in communication with the control unit 14 for initiating or triggering one or more alerts or therapeutic delivery modifications during operation of the medical device).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Kang with a second balloon portion having an expansion region distinguished from an expansion region of the first balloon portion, and expanded to form a curved line such that a distance in a direction perpendicular to a longitudinal axis of the balloon catheter increases from its portion connected to the first balloon portion; a sensor monitoring unit configured to monitor esophageal tissue sensed by a sensor provided in the balloon catheter; and a controller configured to receive measurement information from the sensor monitoring unit to control a light source of the light irradiation unit as taught by Sara. Since Sara further teaches the treatment catheter being configured to deliver laser energy [0034], such a modification would provide the predictable results of being able to independently inflate the balloon lobes and initiate therapeutic delivery (laser energy) modifications based on sensed data (Sara, [0025], [0034]).
Regarding claim 2, the modified Kang discloses the system of claim 1 as discussed above, but fails to disclose a fluid management unit configured to supply fluid to expand the balloon catheter and remove the supplied fluid, wherein the fluid management unit is controlled by the controller. However, Sara discloses a fluid management unit (a fluid supply including one or more reservoirs 36) configured to supply fluid to expand the balloon catheter and remove the supplied fluid, wherein the fluid management unit is controlled by the controller ([0027] control unit 14 may include a fluid supply including one or more reservoirs 36 for one or more coolants, cryogenic refrigerants, or the like, an exhaust or scavenging system for recovering or venting expended fluid for reuse or disposal).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Kang with a fluid management unit configured to supply fluid to expand the balloon catheter and remove the supplied fluid, wherein the fluid management unit is controlled by the controller as taught by Sara. Such a modification would provide the predictable results of creating a low-pressure environment in one or more conduits within the catheter when desired (Sara, [0027]).
Regarding claim 3, Kang discloses wherein the first balloon portion is expanded into a region rotated around a movement path of the light irradiation unit (Fig. 4 shows the balloon 320 being inflated around the movement path of the optical fiber 310), but fails to disclose wherein the first balloon portion and the second balloon portion are expanded into a region rotated around a movement path of the light irradiation unit.
However, Sara discloses wherein a first balloon portion and a second balloon portion are expanded into a region rotated around a longitudinal axis of a balloon catheter (Fig. 1 shows a plurality of lobes 20 being arranged about a longitudinal axis 30; [0034] treatment catheter 12 may also be configured for use with laser energy). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Kang with a first balloon portion and a second balloon portion are expanded into a region rotated around a longitudinal axis of a balloon catheter as taught by Sara. Such a modification would provide the predictable results of being able to selectively dilate a passage using the second balloon portion while delivering therapy when the first balloon is inflated.
Regarding claim 4, the modified Kang discloses a first balloon portion being expanded to form a straight line having an angle of 0 to 900 with a movement path of the optical fiber (Fig. 4), but fails to disclose wherein the first balloon portion and the second balloon portion are disposed to overlap each other in at least a partial region in a movement direction of the optical fiber. However, Sara discloses wherein the first balloon portion and the second balloon portion are disposed to overlap each other in at least a partial region in a movement about the longitudinal axis (annotated Fig. 1 shows the first and second balloon portions overlapping each other around the longitudinal axis).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Kang with the first balloon portion and the second balloon portion are disposed to overlap each other in at least a partial region in a movement about the longitudinal axis as taught by Sara. Such a modification would provide the predictable results of being able to selectively dilate a passage using the second balloon portion while delivering therapy when the first balloon is inflated.
Regarding claim 5, the modified Kang discloses the system of claim 4 as discussed above, but fails to disclose wherein the first balloon portion and the second balloon portion are supplied with fluid separately by the controller. However, Sara discloses wherein the first balloon portion and the second balloon portion are supplied with fluid separately by the controller ([0025] each of the balloon lobes 20 may be inflated and deflated independently of each other; [0027] control unit 14 may also include an additional fluid supply including a reservoir 38 containing a non-coolant liquid, gas, or combination liquid and gas used to inflate the balloon lobes 20).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Kang with the first balloon portion and the second balloon portion are supplied with fluid separately by the controller as taught by Sara. Such a modification would provide the predictable results of selectively inflating the balloon lobes (Sara, [0025]).
Regarding claim 14, the modified Kang discloses the system of claim 3 as discussed above, but fails to disclose wherein an angle between any tangent line in contact with the second balloon portion and the movement path is 20 to 600. However, Sara discloses wherein an angle between any tangent line in contact with the second balloon portion and the movement path is 20 to 600 (annotated Fig. 1 shows a tangent line in contact with the second balloon portion and the longitudinal axis making an angle between 22.5 and 45 degrees).
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Annotated Fig. 1: The solid arrow is a tangent line in contact with the second balloon portion and the longitudinal axis
It would have been obvious before the effective filing date of the claimed invention to modify the system as taught by Kang with an angle between any tangent line in contact with the second balloon portion and the movement path being 20 to 600 as taught by Sara since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Regarding claim 17, Kang discloses an apparatus for laser treatment of gastro-esophageal reflux disease using a balloon catheter, comprising:
a light irradiation unit (optical fiber) configured to irradiate light to esophageal tissue [0063];
a balloon catheter (inflatable balloon catheter 320) having the light irradiation unit inserted thereinto ([0089] optical fiber 310 is positioned in the inflatable balloon catheter 320), expanded by fluid so that the light irradiation unit is disposed on one side of an interior, and configured to expand the esophageal tissue ([0096] fluid may be supplied into the inflatable balloon catheter 320 to expand the catheter),
wherein the balloon catheter includes a first balloon portion configured to closely contact a treatment target region of the esophageal tissue in a movement direction of the light irradiation unit ([0090-0091] inflatable balloon 320 contains the optical fiber 310 positioned inside the catheter and inflates to expand the tissue; Fig. 4).
Kang fails to disclose wherein the balloon catheter includes a first balloon portion configured to closely contact a treatment target region of the esophageal tissue and a second balloon portion configured to support the first balloon portion, and wherein the first balloon portion and the second balloon portion are disposed to overlap each other in a movement direction of the light irradiation unit and to be separated from each other in a direction perpendicular to a movement path of the light irradiation unit; a sensor monitoring unit configured to monitor the esophageal tissue sensed by a sensor provided in the balloon catheter; and a controller configured to receive measurement information from the sensor monitoring unit to control a light source of the light irradiation unit.
However, Sara discloses wherein the balloon catheter includes a first balloon portion (outer balloon 102) configured to closely contact a treatment target region of the esophageal tissue ([0033] outer balloon 102 may create a smooth tissue contact surface) and a second balloon portion (balloon lobes 20) configured to support the first balloon portion ([0033] outer balloon 102 surrounds the plurality of balloon lobes 20), and
wherein the first balloon portion and the second balloon portion are disposed to overlap each other in a movement direction along a longitudinal axis of the balloon catheter (Fig. 5 shows outer balloon 102 overlapping/surrounding the inner balloon lobes 20 which radially surround an elongate body 24) and to be separated from each other in a direction perpendicular to a longitudinal axis of a balloon catheter (Fig. 5 shows a cross section perpendicular to the longitudinal axis of elongate member 24 where the outer balloon is separated from the inner lobes 20; [0034] catheter 12 may also be configured for use with laser energy);
a sensor monitoring unit (one or more temperature and/or pressure sensors) configured to monitor esophageal tissue sensed by a sensor provided in the balloon catheter ([0034] one or more temperature and/or pressure sensors (not shown) proximate and/or within the balloon treatment element 18 for monitoring, recording or otherwise conveying measurements of conditions within the medical device or the ambient environment at the distal portion of the medical device); and
a controller (control unit 14) configured to receive measurement information from the sensor monitoring unit to control a light source of a light irradiation unit ([0034] catheter 12 may also be used to deliver laser energy and sensor(s) may be in communication with the control unit 14 for initiating or triggering one or more alerts or therapeutic delivery modifications during operation of the medical device; catheter 12 may also be configured for use with laser energy).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Kang with the balloon catheter includes a first balloon portion configured to closely contact a treatment target region of esophageal tissue and a second balloon portion configured to support the first balloon portion, and wherein the first balloon portion and the second balloon portion are disposed to overlap each other in a movement direction along a longitudinal axis of the balloon catheter and to be separated from each other in a direction perpendicular to a longitudinal axis of a balloon catheter; a sensor monitoring unit configured to monitor esophageal tissue sensed by a sensor provided in the balloon catheter; and a controller configured to receive measurement information from the sensor monitoring unit to control a light source of a light irradiation unit as taught by Sara. Since Sara further discloses the treatment catheter being configured to deliver laser energy [0034], such a modification would provide the predictable results of helping smooth the transitional curves between the balloon lobes by creating a smooth tissue contact surface and initiating therapeutic delivery (laser energy) modifications based on sensed data (Sara, [0033-0034]).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kang (US 2021/0153938) in view of Sara (US 2017/0135740) and further in view of Lennox et al (US 4,955,377) hereinafter Lennox
Regarding claim 13, the modified Kang discloses the system of claim 3 as discussed above, but fails to disclose wherein when a length covered by the first balloon portion in the direction perpendicular to the movement path is defined as a first radius, the first radius is 7.5 to 15 mm, and when a length covered by the second balloon portion in the direction perpendicular to the movement path is defined as a second diameter, the second diameter is greater than the first radius and less than 40 mm.
Sara discloses wherein when a length covered by the first balloon portion in the direction perpendicular to the movement path is defined as a first radius, and when a length covered by the second balloon portion in the direction perpendicular to the movement path is defined as a second diameter, the second diameter is greater than the first radius (annotated Fig. 1 shows the first balloon portion having a defined first radius perpendicular to the longitudinal axis and the second balloon portion having a second diameter perpendicular to the longitudinal axis that is greater than the first radius).
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Annotated Fig. 1: The solid line indicates the first radius and the dashed line indicates the second diameter
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Kang with when a length covered by the first balloon portion in the direction perpendicular to the movement path is defined as a first radius, and when a length covered by the second balloon portion in the direction perpendicular to the movement path is defined as a second diameter, the second diameter is greater than the first radius as taught by Sara. Such a modification would provide the predictable results of being able to selectively dilate a passage using the second balloon portion while delivering therapy when the first balloon is inflated.
Lennox discloses a balloon with a first radius being 7.5 to 15 mm, and a diameter being less than 40 mm (Col. 3, ln 12-16: The fully extended diameter of balloon 8, when inflated, ranges from 20 or 35 millimeters for hyperthermia treatment of the prostate, esophagus or colon; Examiner notes that the radius would necessarily be half of the diameter). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Kang with a first radius being 7.5 to 15 mm, and a diameter being less than 40 mm as taught by Lennox. Such a modification would provide the predictable results of using a balloon catheter for hyperthermia treatment of the esophagus (Lennox, Col. 3, ln 12-16).
Examiner submits that the claimed first radius being 7.5 to 15 mm and the second diameter being greater than the first radius and less than 40 mm range is so close to the taught 20 or 35mm that a prima facia case of obviousness exists. One of ordinary skill in the art would expect a balloon diameter with a first radius being 7.5 to 15 mm and a second diameter being greater than the first radius and less than 40 mm to have the same properties as a balloon diameter of 20 or 35mm (MPEP 2144.05(I): "Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America V. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of 'having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium' as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. 'The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.' See also Warner-Jenkinson Co., Inc. V. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)).
Claim(s) 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kang (US 2021/0153938) in view of Sara (US 2017/0135740) and further in view of Edwards (US 6,692,490).
Regarding claim 6, the modified Kang discloses the system of claim 1 as discussed above, but fails to disclose wherein a plurality of sensors form an array and are provided on an outer side of the first balloon portion. However, Edwards discloses wherein a plurality of the sensors (surface electrodes 322) form an array (basket-like structure 321) and are provided on an outer side of the first balloon portion (Fig. 3; Col. 10, ln 14-15: treatment balloon 320 also includes a flexible basket-like structure 321 and a set of surface electrodes 322). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Kang with a plurality of sensors form an array and are provided on an outer side of the first balloon portion as taught by Edwards. Such a modification would provide the predictable results of monitoring any physical or chemical changes in the tissue induced by the treatment balloon.
Regarding claim 9, the modified Kang discloses the system of claim 6 as discussed above, but fails to disclose wherein the sensor array measures a temperature, tissue deformation, PH, and a mucosal impedance of the esophageal tissue. However, Edwards discloses wherein a sensor array (basket-like structure 321) measures a temperature, tissue deformation (pressure), PH, and a mucosal impedance of the esophageal tissue (Col. 10, ln 18-22: electrodes 322 are evenly distributed on all the members of the basket-like structure 321. Each electrode 322 includes a sensor 323 to measure temperature, pressure, impedance, flow, nervous activity, pH).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Kang with a sensor array that measures a temperature, tissue deformation, PH, and a mucosal impedance of the esophageal tissue as taught by Edwards. Such a modification would provide the predictable results of monitoring any physical or chemical changes in the tissue induced by the treatment balloon.
Claim(s) 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kang (US 2021/0153938) in view of Sara (US 2017/0135740) and further in view of Schultheis et al (US 2021/0267685) hereinafter Schultheis.
Regarding claim 7, the modified Kang discloses the system of claim 2 as discussed above, but fails to disclose wherein the fluid management unit includes an air trap remover configured to remove an air trap inside the balloon catheter, and a cooler configured to generate a cooling fluid for lowering a temperature of the fluid.
Sara discloses wherein the fluid management unit includes a cooler configured to generate a cooling fluid for lowering a temperature of the fluid ([0027] control unit 14 may include a fluid supply including one or more reservoirs 36 for one or more coolants, cryogenic refrigerants, or the like). It would have been obvious before the effective filing date of the claimed invention to modify the system as taught by Kang with the fluid management unit includes a cooler configured to generate a cooling fluid for lowering a temperature of the fluid as taught by Sara. Such a modification would provide the predictable results of cooling tissue by delivering a cooling fluid to the balloon after ablation.
Schultheis discloses an air trap remover (fluid recirculation system) configured to remove an air trap inside the balloon catheter ([0028] the fluid recirculation system can be used to remove any undesired air bubbles that may have been formed within the catheter fluid within the balloon). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Kang with an air trap remover configured to remove an air trap inside the balloon catheter as taught by Schultheis. Such a modification would provide the predictable results of removing bubbles so the balloon can properly expand and evenly apply pressure to the surrounding tissue.
Regarding claim 12, the modified Kang discloses the system of claim 7 as discussed above, but fails to disclose wherein the cooling fluid is injected to flow along an inner surface of the balloon or the movement path. However, Sara discloses wherein the cooling fluid is injected to flow along an inner surface of the balloon or the movement path ([0036] flow rate and/or injection pressure of the cryogenic refrigerant being delivered by the delivery lumen 82 to each balloon lobe 20). It would have been obvious before the effective filing date of the claimed invention to modify the system as taught by Kang with the cooling fluid is injected to flow along an inner surface of the balloon or the movement path as taught by Sara. Such a modification would provide the predictable results of cooling tissue by delivering a cooling fluid to the balloon after ablation.
Claim(s) 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kang (US 2021/0153938) in view of Sara (US 2017/0135740) and further in view of Scheuermann et al (US 2013/0165764) hereinafter Scheuermann.
Regarding claim 8, Kang discloses wherein the balloon catheter includes:
the optical fiber ([0089] optical fiber 310);
an optical fiber tip (protective cap 370) formed to surround the inserted optical fiber and configured to uniformly distribute light emitted from the optical fiber to the esophageal tissue ([0086] protective cap 370 may be made of transparent plastic, transparent acrylic, glass, quartz, PDMS, PTFE, or the like);
a flexible tip disposed (olive tip 362) in a front end to be guided and inserted into the esophageal tissue ([0095] an olive tip 362 may be provided at the end of the transmission instrument to minimize the injury and the hole); and
a guide wire (guide wire 340) configured to guide by penetrating through the flexible tip ([0098] guide wire 340 is configured to ensure an entry route of the endoscope or the narrow channel and positioned inside or outside the transmission tube 330).
Kang fails to disclose a balloon formed of a transparent material so that light emitted from the optical fiber tip is irradiated to the esophageal tissue and expanded when fluid flows therein, and including the first balloon portion and the second balloon portion.
However, Scheuermann discloses a balloon formed of a transparent material so that light emitted from the optical fiber tip is irradiated to the esophageal tissue and expanded when fluid flows therein ([0022] The balloon may have a transparent balloon wall and may have a transparent expansion fluid), and
including the first balloon portion and the second balloon portion ([0022] The positioning element may comprise a non-occluding balloon such as a multi-lobed balloon).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Kang with a balloon formed of a transparent material so that light emitted from the optical fiber tip is irradiated to the esophageal tissue and expanded when fluid flows therein, and including the first balloon portion and the second balloon portion as taught by Scheuermann. Such a modification would provide the predictable results of easy identification during imaging.
Regarding claim 10, Kang discloses a delivery tubing ([0102] transmission tube 330) provided with a first channel ([0102] first channel 330a) for accommodating a sensor wire connected to the sensor,
a second channel ([0102] second channel 330b) for accommodating the optical fiber and allowing for entry and exit of a material to expand the balloon catheter, and
a third channel ([0102] third channel 330c) for accommodating the guide wire to secure an entry path; and
an endoscope (endoscope) portion formed to surround at least a portion of the delivery tubing ([0097] transmission tube 330 is configured to insert the transmission instrument 300 into the endoscope).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kang (US 2021/0153938) in view of Sara (US 2017/0135740) and Scheuermann (US 2013/0165764) and further in view of Rondel (US 2025/0017458).
Regarding claim 11, the modified Kang discloses the system of claim 10 as discussed above, but fails to disclose wherein the endoscope portion includes: an endoscope camera; and a filter attached to the endoscope portion and configured to protect the endoscope camera.
However, Rondel discloses wherein the endoscope portion ([0037] endoscope tip 114) includes:
an endoscope camera ([0040] endoscope camera assembly 122); and
a filter (filter 126) attached to the endoscope portion and configured to protect the endoscope camera ([0040] The filter 126 is positioned on the removable cap 124 such that when the removable cap 124 is placed over the endoscope tip 114, the filter 126 covers or optically alights with the endoscope camera assembly 122).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Kang with an endoscope camera; and a filter attached to the endoscope portion and configured to protect the endoscope camera as taught by Rondel. Such a modification would provide predictable results of filtering incident light (Rondel, [0040]).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kang (US 2021/0153938) in view of Sara (US 2017/0135740) and further in view of Walsh et al (US 2017/0079717) hereinafter Walsh.
Regarding claim 15, the modified Kang discloses the system of claim 4 as discussed above, but fails to disclose a reflecting mirror configured to reflect light generated from the light irradiation unit and disposed inside the balloon catheter. However, Walsh discloses a reflecting mirror (mirror 21) configured to reflect light generated from the light irradiation unit and disposed inside the balloon catheter ([0058] mirror can be provided on/toward the distal tip of the light guide inserted into the distal balloon 21).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Kang with a reflecting mirror configured to reflect light generated from the light irradiation unit and disposed inside the balloon catheter as taught by Walsh. Such a modification would provide the predictable results of using a mirror to receive and reflect light emitted from the light guide (Walsh, Abstract).
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kang (US 2021/0153938) in view of Sara (US 2017/0135740) and further in view of Nye et al (US 2010/0262137) hereinafter Nye.
Regarding claim 16, the modified Kang discloses the system of claim 4 as discussed above but fails to disclose wherein the second balloon portion is provided in plural. However, Nye discloses wherein the second balloon portion is provided in plural ([0060] multi-lobe balloon 58; Fig. 7). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Kang with the second balloon portion being provided in plural as taught by Nye. Such a modification would provide the predictable results of selectively cooling or expanding lobes (Nye, [0067]).
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kang (US 2021/0153938) in view of Sara (US 2017/0135740) and further in view of Flores et al (US 2022/0183738) hereinafter Flores.
Regarding claim 18, the modified Kang discloses the system of claim 17 as discussed above, but fails to disclose wherein the light irradiation unit and the balloon catheter are provided in plural, and the controller individually controls the light irradiation unit and the balloon catheter. However, Flores discloses wherein the light irradiation unit (energy guides 222A) and the balloon catheter (balloons 204A-204C) are provided in plural ([0099] each balloon 204A, 204B, 204C includes the guide distal end 222D of at least one energy guide 222A; Fig. 2B), and
the controller (controller 126) individually controls the light irradiation unit and the balloon catheter ([0088] system controller 126 is coupled to and is configured to control operation of each of the energy source 124; [0089] system controller 126 can also be configured to control the inflation of each balloon 104A with the balloon fluid 132).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Kang with the light irradiation unit and the balloon catheter are provided in plural, and the controller individually controls the light irradiation unit and the balloon catheter as taught by Flores. Such a modification would provide the predictable results of selectively inflating each balloon portion (Flores, [0094]) and selective irradiation.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kang (US 2021/0153938) in view of Sara (US 2017/0135740) and further in view of Goodrich et al (US 2019/0290360) hereinafter Goodrich.
Regarding claim 19, the modified Kang discloses the system of claim 17 as discussed above, but fails to disclose an optical mask configured to cover light emitted from an optical fiber tip disposed in an end of the optical fiber. However, Goodrich discloses an optical mask (optical fiber tip 204) configured to cover light emitted from an optical fiber tip disposed in an end of the optical fiber ([0087] the optical fiber tip 204 is configured to inhibit the passage of radiation through the tip and/or the optical fiber tip 204 substantially blocks radiation).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Kang with an optical mask configured to cover light emitted from an optical fiber tip disposed in an end of the optical fiber as taught by Goodrich. Such a modification would provide the predictable results of preventing and/or lowering the amount of heating and/or of irradiation of tissue/material directly in front of the fiber tip 204 (Goodrich, [0087]).
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kang (US 2021/0153938) in view of Sara (US 2017/0135740) and further in view of Rajagopalan et al (US 2017/0333122) hereinafter Rajagopalan.
Regarding claim 20, Kang discloses a method for a laser treatment of gastro-esophageal reflux disease using a balloon catheter, the method comprising:
an insertion operation of inserting a balloon catheter (balloon 320) through an endoscope channel ([0097] transmission tube 330 is configured to insert the transmission instrument 300 into the endoscope or the narrow channel and serves to deliver the optical fiber 310, the inflatable balloon catheter 320, and the guide wire 340);
an inflating operation of injecting fluid into the balloon catheter and disposing the fluid on esophageal tissue ([0103] fluid for expanding the inflatable balloon catheter 320);
an irradiation operation of irradiating light to the irradiation position ([0090] during optical irradiation); and
a moving operation of moving a position of an optical fiber inside the balloon catheter and irradiating light ([0090] the optical fiber 310 positioned in the catheter is not in direct contact with the tissue during the optical irradiation); and
wherein the balloon catheter includes a first balloon portion into which the optical fiber is inserted and which is expanded to form a straight line having an angle of 00 to 900 with respect to a movement path of the optical fiber (Fig. 4 shows balloon catheter forming a straight line having an angle of 00 with respect to the movement path of the optical fiber 310).
Kang fails to disclose an adjustment operation of adjusting an amount of fluid to be based on feedback from a sensor provided on an outer side of the balloon catheter such that the balloon catheter is adjusted to an irradiation position; and a second balloon portion having an expansion region distinguished from an expansion region of the first balloon portion and being expanded to form a curved line such that a distance in a direction perpendicular to the movement path of the optical fiber increases from a portion of the second balloon portion connected to the first balloon portion.
However, Sara discloses a balloon catheter ([0025] treatment catheter 12; [0034] treatment catheter 12 may be configured to deliver laser energy) including a first balloon portion ([0025] plurality of lobes 20), and
a second balloon portion having an expansion region distinguished from an expansion region of the first balloon portion ([0025] each of the balloon lobes 20 may be inflated and deflated independently of each other), and being expanded to form a curved line such that a distance in a direction perpendicular to a longitudinal axis of the balloon catheter increases from its portion connected to the first balloon portion (see annotated Fig. 1);
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Annotated Fig. 1: The solid arrow points to a first balloon portion, the dashed arrow points to a second balloon portion having a distinguished expansion region that expands to form a curved line and an increased distance in a direction perpendicular to a longitudinal axis of the balloon catheter, and the circle encompasses the connected portion
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Kang with a second balloon portion having an expansion region distinguished from an expansion region of the first balloon portion, and being expanded to form a curved line such that a distance in a direction perpendicular to a longitudinal axis of the balloon catheter increases from its portion connected to the first balloon portion as taught by Sara. Such a modification would provide the predictable results of being able to independently inflate the balloon lobes (Sara, [0025]).
Rajagopalan discloses an adjustment operation of adjusting an amount of fluid to be based on feedback from a sensor provided on an outer side of the balloon catheter ([0209] functional elements 29, 39, 49, and/or 139 can comprise a pressure sensor; Fig 1 shows functional elements 29, 39, 49, and/or 139 being disposed on the exterior of the balloons) such that the balloon catheter is adjusted to an irradiation position ([0224] fluid can be delivered to inflate the balloon until a pressure sensor attached to the proximal end of the device determines a stable pressure).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Kang with an adjustment operation of adjusting an amount of fluid to be based on feedback from a sensor provided on an outer side of the balloon catheter such that the balloon catheter is adjusted to an irradiation position as taught by Rajagopalan. Such a modification would provide the predictable results of slowly inflating the balloon until a threshold pressure is achieved (Rajagopalan, [0224]).
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.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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