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 Preliminary Amendment
This Office Action is responsive to the preliminary amendment filed 06 November 2025. As directed by the amendment: Claims 1-2 have been amended, claims 13-14 have been added, and no claims have been cancelled. Thus, claims 1-14 are presently pending under examination.
Response to Arguments
Applicant’s arguments, see pg. 6-11 of Remarks, filed 11/06/2025 with respect to the rejection(s) of claim(s) 1 and 2 under 35 U.S.C. 103 under Nishigishi in view of Samson (alternatively Ainsworth) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gregory et al. (US Patent 5,304,171 A), hereinafter Gregory.
Applicant has amended independent claims 1 and 2 to recite the limitation of “the optical fiber is joined to a distal end of the first lumen to seal the distal end of the first lumen so that there is no gap at a joint portion between the distal end of the first lumen and the optical fiber, and the first lumen is not communicated with the second lumen through the joint portion” (emphasis added) and further argues that Nishigishi fails to teach this limitation. Examiner agrees and has instead used Gregory to teach this limitations.
Gregory teaches a flowing fluid laser catheter for delivering laser energy (claim 1) wherein the optical fiber (Figure 13: optical fiber 114) is joined to a distal end of the first lumen to seal the distal end of the first lumen so that there is no gap at a joint portion between the distal end of the first lumen and the optical fiber (Figure 13: cap 106 with bore 107, Column 10, line 66-Column 11, line 4: “Proximal end 108 of coupler 100 is affixed with a cap 106, which is provided with bore 107 through which conventional optical fiber 114 can pass. Proximal cap 106 is provided with annular groove 110, which accommodates O-ring 112 to provide a seal between proximal cap 106 and fiber 114.” Examiner interprets the cap 106 with the bore 107 to be the first lumen.), and the first lumen is not communicated with the second lumen through the joint portion (view Figure 13: conduit 104, Examiner interprets the conduit 104 to be the second lumen., Column 4, line 68-Column 5, line 8: “A cap is affixed to the first end of the tube; the cap is arranged and adapted to substantially restrict movement of the liquid out from the tube by way of the first end; the cap is configured to provide a smooth and rounded proximal surface; the cap has a bore through it substantially aligned with the axis of the tube, preferably of a diameter sufficiently to permit passage of a guidewire through it, preferably sufficiently small to restrict the flow of the liquid through it”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi in view of Samson (alternatively, in view of Ainsworth) to incorporate the teachings of Gregory to have the optical fiber is joined to a distal end of the first lumen to seal the distal end of the first lumen so that there is no gap at a joint portion between the distal end of the first lumen and the optical fiber, and the first lumen is not communicated with the second lumen through the joint portion, as these prior art references are directed to balloon catheters with guidewires or optical fibers. One would be motivated to do this to restrict the outflow of liquid from the distal end of the catheter lumen, as recognized by Gregory (Claim 1).
Therefore, claims 1-5, 8-10, and 13-14 are rejected as described in detail below under 35 U.S.C. 103.
No additional specific arguments were presented for previously set forth 35 U.S.C. 103 rejections of dependent claims 3, 6-8, and 11-12, nor specifically with respect to the previously cited references: Maki, Farr, Maguire, Gregory, and El-Nounou.
Therefore, claims 3, 6-8, and 11-12 remain rejected under 35 U.S.C 103, as described in detail below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 and 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishigishi (US Patent 8,864,705 B2, previously cited), hereinafter Nishigishi in view of Samson et al. (US Patent 5,090,959 A, previously cited), hereinafter Samson or alternatively in view of Ainsworth et al. (US Patent 7,783,338 B2, previously cited), hereinafter Ainsworth, further in view of Gregory et al. (US Patent 5,304,171 A), hereinafter Gregory.
Regarding claim 1, Nishigishi discloses a balloon catheter (a balloon catheter 10) extending in a longitudinal direction from a proximal side to a distal side (view Figure 1) comprising: a first shaft (opening control portion 33) having a first lumen (control hole 36b) and a second lumen (guidewire lumen 51); a second shaft located distal to the first shaft (front outer shaft portion 31 , view Figure 1); a balloon (Figure 1: balloon 20) located distal to the second shaft (view Figure 1, Column 3, lines 62-64: “The rear attachment portion 23 of the balloon 20 is fixed to the outer surface of the front outer shaft portion 31 at the distal end thereof.”); wherein the first shaft is made of a resin (Column 7, lines 56-58:"the opening control portion 33…which are made of resin"), a cross-sectional area of the resin forming the first shaft is larger than each of cross- sectional areas of either the first lumen and the second lumen, in a cross section perpendicular to the longitudinal direction (Column 4, lines 1-5: "The outer diameter of the front outer shaft portion 31 is substantially equal to the outer diameter of the opening control portion 33. The outer diameter of the front outer shaft portion 31 may be set from about 0.85 mm to about 0.95 mm, and is set to about 0.90 mm in the present embodiment.", Column 4, lines 59-62: "The diameter D of the first hole section 36b1 and the second hole section 36b2 may be set from about 0.20 mm to about 0.30 mm, and is set to about 0.25 mm in the present embodiment.", View Figure 3), a proximal end of the balloon is joined to the second shaft (view Figure 1, Column 3, lines 62-64: “The rear attachment portion 23 of the balloon 20 is fixed to the outer surface of the front outer shaft portion 31 at the distal end thereof.”)
Nishigishi fails to disclose an optical fiber disposed inside the balloon, the optical fiber is joined to a distal end of the first lumen to seal the distal end of the first lumen so that there is no gap at a joint portion between the distal end of the first lumen and the optical fiber, and the first lumen is not communicated with the second lumen through the joint portion, and a distal end of the balloon is joined to the optical fiber.
However, Samson teaches an imaging balloon dialatation catheter wherein an optical fiber (optical fibers 21) disposed inside the balloon (balloon 26, View Figure 5) , the optical fiber is joined to a distal end of the first lumen (view Figure 5, Column 2, lines 30-32: “A plurality of discrete illumination optical fibers 21 are provided in the lumen 18 as for example three of such fibers as shown.”), and a distal end of the balloon is joined to the optical fiber (view Figure 5).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi to incorporate the teachings of Samson to have an optical fiber disposed inside the balloon, the optical fiber is joined to a distal end of the first lumen, and a distal end of the balloon is joined to the optical fiber, as these prior art references are directed to balloon catheters. One would be motivated to do this to provide imaging capabilities, as recognized by Samson (Column 1, lines 11-20).
Alternatively, Ainsworth teaches an intravascular device to perform a treatment wherein an optical fiber (optical fibers 20) disposed inside the balloon (balloon 15, View Figure 2) , the optical fiber is joined to a distal end of the first lumen (Column 6, lines 57-59: “at least one optical fiber 20 is inserted into the intraluminal space or gap 180 between the outer member 130 and the inner member 120”, Column 6, lines 37-41: “the optical fiber(s) 20 may be positioned in a number of configurations, for example within a lumen of the shaft inner member, within an intraluminal gap or lumen between the catheter shaft inner and outer members”), and a distal end of the balloon is joined to the optical fiber (Column 6, lines 66-67: “the optical fiber 20 could be jointly bonded at the proximal balloon seal 102”, view Figure 2)
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi to incorporate the teachings of Ainsworth to have an optical fiber disposed inside the balloon, the optical fiber is joined to a distal end of the first lumen, and a distal end of the balloon is joined to the optical fiber, as these prior art references are directed to balloon catheters. One would be motivated to do this to perform a therapeutic treatment and diagnosis of a patient’s vessel, as recognized by Ainsworth (Column 1, line 62- Column 2, line 15).
Although, Samson and Ainsworth teach an optical fiber is joined to a distal end of the first lumen (Samson: Figure 2 and 5 and Ainsworth: Figure 7))) such that the optical fiber is touching the walls of the first lumen (i.e. “joined”), these prior art references and Nishigishi, alone or in combination, fail to teach the optical fiber is joined to a distal end of the first lumen to seal the distal end of the first lumen so that there is no gap at a joint portion between the distal end of the first lumen and the optical fiber, and the first lumen is not communicated with the second lumen through the joint portion.
However, Gregory teaches a flowing fluid laser catheter for delivering laser energy (claim 1) wherein the optical fiber (Figure 13: optical fiber 114) is joined to a distal end of the first lumen to seal the distal end of the first lumen so that there is no gap at a joint portion between the distal end of the first lumen and the optical fiber (Figure 13: cap 106 with bore 107, Column 10, line 66-Column 11, line 4: “Proximal end 108 of coupler 100 is affixed with a cap 106, which is provided with bore 107 through which conventional optical fiber 114 can pass. Proximal cap 106 is provided with annular groove 110, which accommodates O-ring 112 to provide a seal between proximal cap 106 and fiber 114.” Examiner interprets the cap 106 with the bore 107 to be the first lumen.), and the first lumen is not communicated with the second lumen through the joint portion (view Figure 13: conduit 104, Examiner interprets the conduit 104 to be the second lumen., Column 4, line 68-Column 5, line 8: “A cap is affixed to the first end of the tube; the cap is arranged and adapted to substantially restrict movement of the liquid out from the tube by way of the first end; the cap is configured to provide a smooth and rounded proximal surface; the cap has a bore through it substantially aligned with the axis of the tube, preferably of a diameter sufficiently to permit passage of a guidewire through it, preferably sufficiently small to restrict the flow of the liquid through it”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi in view of Samson (alternatively, in view of Ainsworth) to incorporate the teachings of Gregory to have the optical fiber is joined to a distal end of the first lumen to seal the distal end of the first lumen so that there is no gap at a joint portion between the distal end of the first lumen and the optical fiber, and the first lumen is not communicated with the second lumen through the joint portion, as these prior art references are directed to balloon catheters with guidewires or optical fibers. One would be motivated to do this to restrict the outflow of liquid from the distal end of the catheter lumen, as recognized by Gregory (Claim 1).
Regarding claim 3, Nishigishi in view of Samson (alternatively, in view of Ainsworth) in view of Gregory teaches the balloon catheter according to claim 1 (as shown above). Nishigishi fails to explicitly disclose wherein a length of the second shaft in the longitudinal direction is 10 times or more a minimum outer diameter of the second shaft.
However, Nishigishi discloses where “the overall length of the balloon catheter 10 is 1,500 mm.” (Column 3, lines 33-36), “the length of the opening control portion 33 is the axial direction may be set from about 3.0 mm to about 7.0 mm” (Column 4, lines 16-18), “the length of the intermediate outer shaft portion 35 in the axial direction may be set in the range of about 150.0 mm to about 200.0 mm, and is set to about 160.0 mm in the present embodiment” (Column 5, lines 21-24), and that the "the outer diameter of the front outer shaft portion 31 is substantially equal to the outer diameter of the opening control portion 33. The outer diameter of the front outer shaft portion 31 may be set from about 0.85 mm to about 0.95 mm, and is set to about 0.90 mm in the present embodiment." (Column 4, lines 1-5).
It would have been obvious to one of ordinary skill in the art that the length of the second shaft (front outer shaft portion 31) in the longitudinal direction is 10 times or more a minimum outer diameter of the second shaft (10* 0.85 mm = 8.5 mm), as it appears from figure 1 that the second shaft is longer than the opening control portion which is measured to be between 3-7 mm, therefore it would have been known to one skilled in the art that the length of the second shaft will be around 8.5 or more millimeters.
Additionally, Examiner would like to note it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have a length of the second shaft in the longitudinal direction is 10 times or more a minimum outer diameter of the second shaft, to allow for flexibility of the catheter, and since it has been held that changing the size/proportion was a matter of choice one of ordinary skill in the art would have found obvious. See MPEP 2144.04 IV.A. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Additionally, the present disclosure has no criticality for having the length of the second shaft in the longitudinal direction is 10 times or more a minimum outer diameter of the second shaft.
Regarding claim 4, Nishigishi in view of Samson (alternatively, in view of Ainsworth) in view of Gregory teaches the balloon catheter according to claim 1 (as shown above). Nishigishi fails to disclose wherein the optical fiber is disposed in a lumen of the second shaft so that a position of a central axis of an outer shape of the second shaft is different from a position of a central axis of an outer shape of the optical fiber in a cross section perpendicular to the longitudinal direction at a proximal end of the second shaft.
However, Samson teaches wherein the optical fiber is disposed in a lumen of the second shaft (Column 2, lines 10-14: “three lumens 17, 18 and 19 are provided in the elongate flexible tubular member 13 with the lumen 17 being identified as a guidewire lumen, the lumen 18 being identified as the illumination optical fiber lumen”) so that a position of a central axis of an outer shape of the second shaft is different from a position of a central axis of an outer shape of the optical fiber in a cross section perpendicular to the longitudinal direction at a proximal end of the second shaft (view Examiner modified Figure 4).
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Examiner Modified Figure 4 (Samson)
It would have been prima facia obvious for one of ordinary skill in the art to have modified Nishigishi and Gregory to incorporate the teachings of Samson to have the optical fiber is disposed in a lumen of the second shaft so that a position of a central axis of an outer shape of the second shaft is different from a position of a central axis of an outer shape of the optical fiber in a cross section perpendicular to the longitudinal direction at a proximal end of the second shaft, as these prior art references are directed to balloon catheters. One would be motivated to do this to enhance the flexibility of the catheter.
Additionally, Examiner would like to note it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the optical fiber is disposed in a lumen of the second shaft so that a position of a central axis of an outer shape of the second shaft is different from a position of a central axis of an outer shape of the optical fiber in a cross section perpendicular to the longitudinal direction at a proximal end of the second shaft, to allow for flexibility of the catheter, and since it has been held that the rearrangement of parts was a matter of choice one of ordinary skill in the art would have found obvious and does not change the functionality of the device. See MPEP 2144.04 VI.C. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Additionally, the present disclosure has no criticality for having the optical fiber is disposed in a lumen of the second shaft so that a position of a central axis of an outer shape of the second shaft is different from a position of a central axis of an outer shape of the optical fiber in a cross section perpendicular to the longitudinal direction at a proximal end of the second shaft.
Regarding claim 5, Nishigishi in view of Samson (alternatively, in view of Ainsworth) in view of Gregory teaches the balloon catheter according to claim 1 (as shown above). Nishigishi fails to disclose wherein an area of a gap between an inner surface of the second shaft and an outer surface of the optical fiber is 40% or more of an area of a lumen of the second shaft in a cross section perpendicular to the longitudinal direction of the second shaft.
However, Samson teaches wherein “three lumens 17, 18 and 19 are provided in the elongate flexible tubular member 13 with the lumen 17 being identified as a guidewire lumen, the lumen 18 being identified as the illumination optical fiber lumen and the lumen 19 being identified as the imaging optical fiber lumen… the lumens 18 and 19 a diameter of 0.015 inches and the elongate flexible tubular member 13 can have a suitable outside diameter as for example 0.056 inches” (Column 2, lines 10-26).
Therefore, to one having ordinary skill in the art it would have been known that an area of a gap between an inner surface of the second shaft and an outer surface of the optical fiber (area of the elongate flexible tubular member – area of the optical fiber lumen) is 40% or more of an area of a lumen of the second shaft in a cross section perpendicular to the longitudinal direction of the second shaft (area of the optical fiber lumen). Examiner calculates the area of the elongate flexible tubular membrane to be:
0.25*π*(diameter of the elongate flexible tubular member)2 = 0.25*π*0.0562 = (78.4 x 10-5)π in2
And the area of the optical fiber lumen to be:
0.25*π*(diameter of the optical fiber lumen)2 = 0.25*π*0.0152 = (5.62 x 10-5)π in2
Therefore, the area of a gap between an inner surface of the second shaft and an outer surface of the optical fiber would be:
Area of the elongate flexible tubular membrane – the area of the optical fiber lumen = (78.4 x 10-5)π in - (5.62 x 10-5)π in = (72.78 x 10-5)π in2
Which is 40% or more of an area of a lumen of the second shaft in a cross section perpendicular to the longitudinal direction of the second shaft:
(40%)*(5.62 x 10-5)π in2 = (2.248 * x 10-5)π in2 < (72.78 x 10-5)π in2
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi and Gregory to incorporate the teachings of Samson to have wherein an area of a gap between an inner surface of the second shaft and an outer surface of the optical fiber is 40% or more of an area of a lumen of the second shaft in a cross section perpendicular to the longitudinal direction of the second shaft, as these prior art references are directed to balloon catheters. One would be motivated to do this to allow the optical fiber to be accommodate effectively in the catheter during bending of the flexible shaft.
Additionally, Examiner would like to note it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to an area of a gap between an inner surface of the second shaft and an outer surface of the optical fiber is 40% or more of an area of a lumen of the second shaft in a cross section perpendicular to the longitudinal direction of the second shaft, to allow for flexibility of the catheter while maintain a good position of the optical fiber, and since it has been held that changing the size/proportion was a matter of choice one of ordinary skill in the art would have found obvious. See MPEP 2144.04 IV.A. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Additionally, the present disclosure has no criticality for the inner surface of the second shaft and an outer surface of the optical fiber is 40% or more of an area of a lumen of the second shaft in a cross section perpendicular to the longitudinal direction of the second shaft.
Claim(s) 2, 8-10, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishigishi in view of El-Nounou (US 20030208221 A1, previously cited), hereinafter El-Nounou in view of Samson, or alternatively further in view of Ainsworth, further in view of Gregory et al. (US Patent 5,304,171 A), hereinafter Gregory.
Regarding claim 2, Nishigishi discloses a balloon catheter (a balloon catheter 10) extending in a longitudinal direction from a proximal side to a distal side (view Figure 1) comprising: a first shaft (opening control portion 33) the first lumen (control hole 36b) and a second lumen (guidewire lumen 51) are formed in the first shaft (view Figure 3); a second shaft located distal to the first shaft (front outer shaft portion 31 , view Figure 1); a balloon (Figure 1: balloon 20) located distal to the second shaft (view Figure 1, Column 3, lines 62-64: “The rear attachment portion 23 of the balloon 20 is fixed to the outer surface of the front outer shaft portion 31 at the distal end thereof.”); a proximal end of the balloon is joined to the second shaft (view Figure 1, Column 3, lines 62-64: “The rear attachment portion 23 of the balloon 20 is fixed to the outer surface of the front outer shaft portion 31 at the distal end thereof.”)
Nishigishi fails to disclose an inner tube having a first lumen; a first shaft, in which the inner tube is provided; an optical fiber disposed inside the balloon, wherein at least a part of an outer surface of the inner tube is fixed to an inner surface of the first shaft, the optical fiber is joined to a distal end of the first lumen of the inner tube to seal the distal end of the first lumen so that there is no gap at a joint portion between the distal end of the first lumen and the optical fiber, and the first lumen is not communicated with the second lumen through the joint portion, and a distal end of the balloon is joined to the optical fiber.
However, El-Nounou teaches a catheter wherein an inner tube (a tubular member 17) having a first lumen ([0023] “a tubular member 17 defining a proximal portion of an inflation lumen 18”, [0025] “the inflation lumen 18 within the proximal shaft section is defined by the high strength tubular member 17 and the polymeric reinforcing tubular member 22”); a first shaft (Proximal shaft section 12), in which the inner tube is provided ([0023] “Proximal shaft section 12 comprises a tubular member 17”); wherein at least a part of an outer surface of the inner tube is fixed to an inner surface of the first shaft (view Figure 1: the inner surface of the proximal shaft section 12 is in contact with the outer surface of the tubular member 17).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi to incorporate the teachings of El-Nounou to have an inner tube, having a first lumen; a first shaft, in which the inner tube is provided; wherein at least a part of an outer surface of the inner tube is fixed to an inner surface of the first shaft, as these prior art references are directed to balloon catheters. One would be motivated to do this as the tube can help provide strength/stiffness to the proximal shaft to help facilitate advancement of the catheter withing the patient’s body lumen, as recognized by El-Nounou ([0004], [0009]).
Nishigishi and El-Nounou, alone or in combination, fail to teach an optical fiber disposed inside the balloon, the optical fiber is joined to a distal end of the inner tube, and a distal end of the balloon is joined to the optical fiber.
However, Samson teaches an imaging balloon dialatation catheter wherein an optical fiber (optical fibers 21) disposed inside the balloon (balloon 26, View Figure 5) , the optical fiber is joined to a distal end of the first lumen (view Figure 5, Column 2, lines 30-32: “A plurality of discrete illumination optical fibers 21 are provided in the lumen 18 as for example three of such fibers as shown.”), and a distal end of the balloon is joined to the optical fiber (view Figure 5).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi and El-Nounou to incorporate the teachings of Samson to have an optical fiber disposed inside the balloon, the optical fiber is joined to a distal end of the first lumen, and a distal end of the balloon is joined to the optical fiber, as these prior art references are directed to balloon catheters. One would be motivated to do this to provide imaging capabilities, as recognized by Samson (Column 1, lines 11-20).
Alternatively, Ainsworth teaches an intravascular device to perform a treatment wherein an optical fiber (optical fibers 20) disposed inside the balloon (balloon 15, View Figure 2) , the optical fiber is joined to a distal end of the first lumen (Column 6, lines 57-59: “at least one optical fiber 20 is inserted into the intraluminal space or gap 180 between the outer member 130 and the inner member 120”, Column 6, lines 37-41: “the optical fiber(s) 20 may be positioned in a number of configurations, for example within a lumen of the shaft inner member, within an intraluminal gap or lumen between the catheter shaft inner and outer members”), and a distal end of the balloon is joined to the optical fiber (Column 6, lines 66-67: “the optical fiber 20 could be jointly bonded at the proximal balloon seal 102”, view Figure 2)
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi and El-Nounou to incorporate the teachings of Ainsworth to have an optical fiber disposed inside the balloon, the optical fiber is joined to a distal end of the first lumen, and a distal end of the balloon is joined to the optical fiber, as these prior art references are directed to balloon catheters. One would be motivated to do this to perform a therapeutic treatment and diagnosis of a patient’s vessel, as recognized by Ainsworth (Column 1, line 62- Column 2, line 15).
Although, Samson and Ainsworth teach an optical fiber is joined to a distal end of the first lumen (Samson: Figure 2 and 5 and Ainsworth: Figure 7))) such that the optical fiber is touching the walls of the first lumen (i.e. “joined”), these prior art references, Nishigishi, and El-Nounou, alone or in combination, fail to teach the optical fiber is joined to a distal end of the first lumen to seal the distal end of the first lumen so that there is no gap at a joint portion between the distal end of the first lumen and the optical fiber, and the first lumen is not communicated with the second lumen through the joint portion.
However, Gregory teaches a flowing fluid laser catheter for delivering laser energy (claim 1) wherein the optical fiber (Figure 13: optical fiber 114) is joined to a distal end of the first lumen to seal the distal end of the first lumen so that there is no gap at a joint portion between the distal end of the first lumen and the optical fiber (Figure 13: cap 106 with bore 107, Column 10, line 66-Column 11, line 4: “Proximal end 108 of coupler 100 is affixed with a cap 106, which is provided with bore 107 through which conventional optical fiber 114 can pass. Proximal cap 106 is provided with annular groove 110, which accommodates O-ring 112 to provide a seal between proximal cap 106 and fiber 114.” Examiner interprets the cap 106 with the bore 107 to be the first lumen.), and the first lumen is not communicated with the second lumen through the joint portion (view Figure 13: conduit 104, Examiner interprets the conduit 104 to be the second lumen., Column 4, line 68-Column 5, line 8: “A cap is affixed to the first end of the tube; the cap is arranged and adapted to substantially restrict movement of the liquid out from the tube by way of the first end; the cap is configured to provide a smooth and rounded proximal surface; the cap has a bore through it substantially aligned with the axis of the tube, preferably of a diameter sufficiently to permit passage of a guidewire through it, preferably sufficiently small to restrict the flow of the liquid through it”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi in view of El-Nounou in view of Samson (alternatively, in view of Ainsworth) to incorporate the teachings of Gregory to have the optical fiber is joined to a distal end of the first lumen to seal the distal end of the first lumen so that there is no gap at a joint portion between the distal end of the first lumen and the optical fiber, and the first lumen is not communicated with the second lumen through the joint portion, as these prior art references are directed to balloon catheters with guidewires or optical fibers. One would be motivated to do this to restrict the outflow of liquid from the distal end of the catheter lumen, as recognized by Gregory (Claim 1).
Regarding claim 8, Nishigishi in view of El-Nounou in view of Samson (alternatively, in view of Ainsworth) in view of Gregory teaches the balloon catheter according to claim 2 (as shown above). Nishigishi fails to explicitly disclose wherein a length of the second shaft in the longitudinal direction is 10 times or more a minimum outer diameter of the second shaft.
However, Nishigishi does disclose where “the overall length of the balloon catheter 10 is 1,500 mm.” (Column 3, lines 33-36), “the length of the opening control portion 33 is the axial direction may be set from about 3.0 mm to about 7.0 mm” (Column 4, lines 16-18), “the length of the intermediate outer shaft portion 35 in the axial direction may be set in the range of about 150.0 mm to about 200.0 mm, and is set to about 160.0 mm in the present embodiment” (Column 5, lines 21-24), and that the "the outer diameter of the front outer shaft portion 31 is substantially equal to the outer diameter of the opening control portion 33. The outer diameter of the front outer shaft portion 31 may be set from about 0.85 mm to about 0.95 mm, and is set to about 0.90 mm in the present embodiment." (Column 4, lines 1-5).
It would have been obvious to one of ordinary skill in the art that the length of the second shaft (front outer shaft portion 31) in the longitudinal direction is 10 times or more a minimum outer diameter of the second shaft (10* 0.85 mm = 8.5 mm), as it appears from figure 1 that the second shaft is longer than the opening control portion which is measured to be between 3-7 mm, therefore it would have been known to one skilled in the art that the length of the second shaft will be around 8.5 or more millimeters.
Additionally, Examiner would like to note it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have a length of the second shaft in the longitudinal direction is 10 times or more a minimum outer diameter of the second shaft, to allow for flexibility of the catheter, and since it has been held that changing the size/proportion was a matter of choice one of ordinary skill in the art would have found obvious. See MPEP 2144.04 IV.A. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Additionally, the present disclosure has no criticality for having the length of the second shaft in the longitudinal direction is 10 times or more a minimum outer diameter of the second shaft.
Regarding claim 9, Nishigishi in view of El-Nounou in view of Samson (alternatively, in view of Ainsworth) in view of Gregory teaches the balloon catheter according to claim 2 (as shown above). Nishigishi and El-Nounou, alone or in combination, fail to disclose wherein the optical fiber is disposed in a lumen of the second shaft so that a position of a central axis of an outer shape of the second shaft is different from a position of a central axis of an outer shape of the optical fiber in a cross section perpendicular to the longitudinal direction at a proximal end of the second shaft.
However, Samson teaches wherein the optical fiber is disposed in a lumen of the second shaft (Column 2, lines 10-14: “three lumens 17, 18 and 19 are provided in the elongate flexible tubular member 13 with the lumen 17 being identified as a guidewire lumen, the lumen 18 being identified as the illumination optical fiber lumen”) so that a position of a central axis of an outer shape of the second shaft is different from a position of a central axis of an outer shape of the optical fiber in a cross section perpendicular to the longitudinal direction at a proximal end of the second shaft (view Examiner modified Figure 4).
It would have been prima facia obvious for one of ordinary skill in the art to have modified Nishigishi, El-Nounou, and Gregory to incorporate the teachings of Samson to have the optical fiber is disposed in a lumen of the second shaft so that a position of a central axis of an outer shape of the second shaft is different from a position of a central axis of an outer shape of the optical fiber in a cross section perpendicular to the longitudinal direction at a proximal end of the second shaft, as these prior art references are directed to balloon catheters. One would be motivated to do this to enhance the flexibility of the catheter.
Additionally, Examiner would like to note it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the optical fiber is disposed in a lumen of the second shaft so that a position of a central axis of an outer shape of the second shaft is different from a position of a central axis of an outer shape of the optical fiber in a cross section perpendicular to the longitudinal direction at a proximal end of the second shaft, to allow for flexibility of the catheter, and since it has been held that the rearrangement of parts was a matter of choice one of ordinary skill in the art would have found obvious and does not change the functionality of the device. See MPEP 2144.04 VI.C. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Additionally, the present disclosure has no criticality for having the optical fiber is disposed in a lumen of the second shaft so that a position of a central axis of an outer shape of the second shaft is different from a position of a central axis of an outer shape of the optical fiber in a cross section perpendicular to the longitudinal direction at a proximal end of the second shaft.
Regarding claim 10, Nishigishi in view of El-Nounou further in view of Samson (alternatively, in view of Ainsworth) in view of Gregory teaches the balloon catheter according to claim 2 (as shown above). Nishigishi and El-Nounou, alone or in combination, fail to teach wherein an area of a gap between an inner surface of the second shaft and an outer surface of the optical fiber is 40% or more of an area of a lumen of the second shaft in a cross section perpendicular to the longitudinal direction of the second shaft.
However, Samson teaches wherein “three lumens 17, 18 and 19 are provided in the elongate flexible tubular member 13 with the lumen 17 being identified as a guidewire lumen, the lumen 18 being identified as the illumination optical fiber lumen and the lumen 19 being identified as the imaging optical fiber lumen… the lumens 18 and 19 a diameter of 0.015 inches and the elongate flexible tubular member 13 can have a suitable outside diameter as for example 0.056 inches” (Column 2, lines 10-26).
Therefore, to one having ordinary skill in the art it would have been known that an area of a gap between an inner surface of the second shaft and an outer surface of the optical fiber (area of the elongate flexible tubular member – area of the optical fiber lumen) is 40% or more of an area of a lumen of the second shaft in a cross section perpendicular to the longitudinal direction of the second shaft (area of the optical fiber lumen). Examiner calculates the area of the elongate flexible tubular membrane to be:
0.25*π*(diameter of the elongate flexible tubular member)2 = 0.25*π*0.0562 = (78.4 x 10-5)π in2
And the area of the optical fiber lumen to be:
0.25*π*(diameter of the optical fiber lumen)2 = 0.25*π*0.0152 = (5.62 x 10-5)π in2
Therefore, the area of a gap between an inner surface of the second shaft and an outer surface of the optical fiber would be:
Area of the elongate flexible tubular membrane – the area of the optical fiber lumen = (78.4 x 10-5)π in - (5.62 x 10-5)π in = (72.78 x 10-5)π in2
Which is 40% or more of an area of a lumen of the second shaft in a cross section perpendicular to the longitudinal direction of the second shaft:
(40%)*(5.62 x 10-5)π in2 = (2.248 * x 10-5)π in2 < (72.78 x 10-5)π in2
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi, El-Nounou, and Gregory to incorporate the teachings of Samson to have wherein an area of a gap between an inner surface of the second shaft and an outer surface of the optical fiber is 40% or more of an area of a lumen of the second shaft in a cross section perpendicular to the longitudinal direction of the second shaft, as these prior art references are directed to balloon catheters. One would be motivated to do this to allow the optical fiber to be accommodate effectively in the catheter during bending of the flexible shaft.
Additionally, Examiner would like to note it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to an area of a gap between an inner surface of the second shaft and an outer surface of the optical fiber is 40% or more of an area of a lumen of the second shaft in a cross section perpendicular to the longitudinal direction of the second shaft, to allow for flexibility of the catheter while maintain a good position of the optical fiber, and since it has been held that changing the size/proportion was a matter of choice one of ordinary skill in the art would have found obvious. See MPEP 2144.04 IV.A. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Additionally, the present disclosure has no criticality for the inner surface of the second shaft and an outer surface of the optical fiber is 40% or more of an area of a lumen of the second shaft in a cross section perpendicular to the longitudinal direction of the second shaft.
Regarding claim 13, Nishigishi in view of Samson (alternatively, in view of Ainsworth) in view of Gregory teaches the balloon catheter according to claim 1 (as shown above).
Nishigishi, Samson, and Gregory, alone or in combination, fail to teach wherein the second lumen is communicated with a lumen of the balloon.
However, El-Nounou teaches a catheter with an elongated shaft with a proximal and distal shaft wherein the second lumen (inflation lumen 18) is communicated with a lumen of the balloon ([0023] “. An inflatable balloon 19 is disposed on the distal shaft section 13, and has a proximal skirt section sealingly secured to the distal end of outer tubular member 14 and a distal skirt section sealingly secured to the distal end of inner tubular member 15, so that its interior is in fluid communication with inflation lumen 18”, view Figure 1, [0007]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi, Samson, and Gregory to incorporate the teachings of El-Nounou to have the second lumen be communicated with a lumen of the balloon, as these prior art references are directed to elongated balloon catheter. One would be motivated to do this to provide inflation fluid to the balloon thereby inflating a balloon, as recognized by El-Nounou ([0034]).
Regarding claim 14, Nishigishi in view of El-Nounou in view of Samson (alternatively, in view of Ainsworth) in view of Gregory teaches the balloon catheter according to claim 2 (as shown above).
Nishigishi, Samson, and Gregory, alone or in combination, fail to teach wherein the second lumen is communicated with a lumen of the balloon.
However, El-Nounou teaches a catheter with an elongated shaft with a proximal and distal shaft wherein the second lumen (inflation lumen 18) is communicated with a lumen of the balloon ([0023] “. An inflatable balloon 19 is disposed on the distal shaft section 13, and has a proximal skirt section sealingly secured to the distal end of outer tubular member 14 and a distal skirt section sealingly secured to the distal end of inner tubular member 15, so that its interior is in fluid communication with inflation lumen 18”, view Figure 1, [0007]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi, Samson, and Gregory to incorporate the teachings of El-Nounou to have the second lumen be communicated with a lumen of the balloon, as these prior art references are directed to elongated balloon catheter. One would be motivated to do this to provide inflation fluid to the balloon thereby inflating a balloon, as recognized by El-Nounou ([0034]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishigishi in view of Samson (alternatively in view of Ainsworth) in view of Gregory as applied to claim 1 above, and further in view of Maki Shin et al. (JP H0889499 A, citations below from NPL translation, previously cited), hereinafter Maki Shin .
Regarding claim 6, Nishigishi in view of Samson (alternatively, in view of Ainsworth) in view of Gregory teaches the balloon catheter according to claim 1 (as shown above). Nishigishi, Samson, and Gregory alone or in combination, fail to teach wherein a protrusion is provided on an inner surface of the second shaft so that the protrusion comes into contact with an outer surface of the optical fiber.
However, Maki Shin teaches a catheter with a plurality of optical fibers wherein a protrusion is provided on an inner surface of the second shaft (optical fiber connection tube 17) so that the protrusion comes into contact with an outer surface of the optical fiber (optical fiber 4, view Examiner Modified Figure 5).
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Examiner Modified Figure 5
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi, Samson, and Gregory to incorporate the teachings of Maki Shin to have a protrusion is provided on an inner surface of the second shaft so that the protrusion comes into contact with an outer surface of the optical fiber, as these prior art references are direction to catheters. One would be motivated to do this to reduce breakage due to twisting or external forces and other forces, as recognized by Maki Shin ([0007]).
Additionally, Examiner would like to note that it would have been obvious to one skilled in the art to a protrusion is provided on an inner surface of the second shaft so that the protrusion comes into contact with an outer surface of the optical fiber, in order to stabilize or retain the optical fiber in a certain portion to avoid damage, and since it has been held that changing the shape was a matter of choice one of ordinary skill in the art would have found obvious. See MPEP 2144.04 IV. B. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishigishi in view of El-Nounou further in view of Samson (alternatively in view of Ainsworth) in view of Gregory as applied to claim 2 above, and further in view of Maki Shin et al. (JP H0889499 A, citations below from NPL translation, previously cited), hereinafter Maki Shin .
Regarding claim 11, Nishigishi in view of El-Nounou further in view of Samson (alternatively, in view of Ainsworth) in view of Gregory teaches the balloon catheter according to claim 2 (as shown above). Nishigishi and Samson, alone or in combination, fail to teach wherein a protrusion is provided on an inner surface of the second shaft so that the protrusion comes into contact with an outer surface of the optical fiber.
However, Maki Shin teaches a catheter with a plurality of optical fibers wherein a protrusion is provided on an inner surface of the second shaft (optical fiber connection tube 17) so that the protrusion comes into contact with an outer surface of the optical fiber (optical fiber 4, view Examiner Modified Figure 5).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi, El-Nounou, Samson, and Gregory to incorporate the teachings of Maki Shin to have a protrusion is provided on an inner surface of the second shaft so that the protrusion comes into contact with an outer surface of the optical fiber, as these prior art references are direction to catheters. One would be motivated to do this to reduce breakage due to twisting or external forces and other forces, as recognized by Maki Shin ([0007]).
Additionally, Examiner would like to note that it would have been obvious to one skilled in the art to a protrusion is provided on an inner surface of the second shaft so that the protrusion comes into contact with an outer surface of the optical fiber, in order to stabilize or retain the optical fiber in a certain portion to avoid damage, and since it has been held that changing the shape was a matter of choice one of ordinary skill in the art would have found obvious. See MPEP 2144.04 IV. B. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishigishi in view of Samson in view of Gregory as applied to claim 1 above, and further in view of Farr et al. (US Patent 5,997,571 A, previously cited), hereinafter Farr.
Regarding claim 7, Nishigishi in view of Samson (alternatively, in view of Ainsworth) in view of Gregory teaches the balloon catheter according to claim 1 (as shown above). Nishigishi, Samson, and Gregory, alone or in combination, fail to teach wherein a tip piece is provided on a distal side of the optical fiber, and a distal end of the tip piece is located distal to the distal end of the balloon.
However, Farr teaches a phototherapeutic instrument in the form of a catheter wherein a tip piece (end cap 26, Figure 4 and Figure 6A-6C) is provided on a distal side of the optical fiber (Column 4, line 67-Column 5, line 2: “the optically-transmissive fiber element 14. The fiber element 14 can be connected to the housing 28 and the end cap 26”, view Figures 6A-6C), and a distal end of the tip piece is located distal to the distal end of the balloon (balloon expansion elements 18, view Figure 6A-6C, and Figures 2A-2C)
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi, Samson, and Gregory to incorporate the teachings of Farr to have a tip piece provided on a distal side of the optical fiber, and a distal end of the tip piece is located distal to the distal end of the balloon, as these prior art references are directed to balloon catheters. One would be motivated to do this to safely insert/position a catheter (Figure 6, lines 14-16) and enhancing the diffusion of the energy from the optical fiber.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishigishi in view of El-Nounou further in view of Samson in view of Gregory as applied to claim 2 above, and further in view of Farr et al. (US Patent 5,997,571 A, previously cited), hereinafter Farr.
Regarding claim 12, Nishigishi in view of El-Nounou further in view of Samson (alternatively, in view of Ainsworth) in view of Gregory teaches the balloon catheter according to claim 1 (as shown above). Nishigishi, El-Nounou, Samson, and Gregory, alone or in combination, fail to teach wherein a tip piece is provided on a distal side of the optical fiber, and a distal end of the tip piece is located distal to the distal end of the balloon.
However, Farr teaches a phototherapeutic instrument in the form of a catheter wherein a tip piece (end cap 26, Figure 4 and Figure 6A-6C) is provided on a distal side of the optical fiber (Column 4, line 67-Column 5, line 2: “the optically-transmissive fiber element 14. The fiber element 14 can be connected to the housing 28 and the end cap 26”, view Figures 6A-6C), and a distal end of the tip piece is located distal to the distal end of the balloon (balloon expansion elements 18, view Figure 6A-6C, and Figures 2A-2C)
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi, El-Nounou, Samson, Gregory to incorporate the teachings of Farr to have a tip piece is provided on a distal side of the optical fiber, and a distal end of the tip piece is located distal to the distal end of the balloon, as these prior art references are directed to balloon catheters. One would be motivated to do this to safely insert/position a catheter (Figure 6, lines 14-16) and enhancing the diffusion of the energy from the optical fiber.
Alternatively, claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishigishi in view of Samson (alternatively in view of Ainsworth) in view of Gregory as applied to claim 1 above, and further in view of Maguire et al. (US 2004/0059277 A1, previously cited), hereinafter Maguire.
Regarding claim 3, Nishigishi in view of Samson (alternatively, in view of Ainsworth) in view of Gregory teaches the balloon catheter according to claim 1 (as shown above). Nishigishi and Samson, alone or in combination, fail to explicitly teach wherein a length of the second shaft in the longitudinal direction is 10 times or more a minimum outer diameter of the second shaft.
However, Maguire teaches a system for delivering fluids or agents to blood vessels or body lumens with a delivery catheter ([0005], Abstract) wherein a length of the second shaft in the longitudinal direction ([0261] “the length L2 of distal shaft section 416 is generally between about 1 and about 20 centimeters long, and in one particular variation is about 10 centimeter long”) is 10 times or more a minimum outer diameter of the second shaft ([0261] “The diameter of distal shaft section 416 is generally about 5 French”, Examiner notes that 5 French is equivalent to 0.17 cm and that 10*0.17 = 1.7 cm).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi, Samson, and Gregory to incorporate the teachings of Maguire to have a length of the second shaft in the longitudinal direction is 10 times or more a minimum outer diameter of the second shaft, as these prior art references are directed to catheters. One would be motivated to do this to allow for better flexibility and stability of the catheter.
Alternatively, claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nishigishi in view of El-Nounou in view of Samson (alternatively in view of Ainsworth) in view of Gregory as applied to claim 2 above, and further in view of Maguire et al. (US 2004/0059277 A1, previously cited), hereinafter Maguire.
Regarding claim 8, Nishigishi in view of El-Nounou in view of Samson (alternatively, in view of Ainsworth) in view of Gregory teaches the balloon catheter according to claim 2 (as shown above). Nishigishi, El-Nounou, and Samson, alone or in combination, fail to explicitly teach wherein a length of the second shaft in the longitudinal direction is 10 times or more a minimum outer diameter of the second shaft.
However, Maguire teaches a system for delivering fluids or agents to blood vessels or body lumens with a delivery catheter ([0005], Abstract) wherein a length of the second shaft in the longitudinal direction ([0261] “the length L2 of distal shaft section 416 is generally between about 1 and about 20 centimeters long, and in one particular variation is about 10 centimeter long”) is 10 times or more a minimum outer diameter of the second shaft ([0261] “The diameter of distal shaft section 416 is generally about 5 French”, Examiner notes that 5 French is equivalent to 0.17 cm and that 10*0.17 = 1.7 cm).
It would have been prima facia obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishigishi, El-Nounou, Samson, and Gregory to incorporate the teachings of Maguire to have a length of the second shaft in the longitudinal direction is 10 times or more a minimum outer diameter of the second shaft, as these prior art references are directed to catheters. One would be motivated to do this to allow for better flexibility and stability of the catheter.
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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/ATTIYA SAYYADA HUSSAINI/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792