DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Information Disclosure Statement
2. The Information Disclosure Statement filed on 22 December 2023 has been considered by the Examiner.
Claim Rejections - 35 USC § 103
3. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
4. Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Clark et al. (US 2015/0088113 A1) in view of Cheung et al. (US 2012/0150107 A1).
Regarding claim 1, Clark teaches a medical device (cryotherapeutic device 120 [abstract]), comprising:
an elongate shaft (figure 2-3 illustrates the cryotherapeutic device 120 comprising an elongate shaft or sheath 154 [0039, 0052, FIGS. 2-3]);
an inner shaft disposed within the elongate shaft (the inner shaft 122 is disposed within the sheath 154 [0052, FIGS. 2-3]), the inner shaft defining:
a first lumen defining a dedicated first port (figures 7A-7B illustrates the inner shaft 122 comprising a supply lumen 732 that defines a first port 740 (e.g., inflow port) [0085, FIGS. 7A-7B]);
an exhaust lumen offset from the first lumen (figures 7A-7B illustrates the inner shaft 122 comprising an exhaust passage or lumen 750 being offset from the supply lumen 732 [0085-0086, FIGS. 7A-7B]) and defining a dedicated second port (the exhaust passage or lumen 750 defines the second port 752 (e.g., exhaust port) [0085-0086, FIGS. 7A-7B]);
a dedicated third port (figures 7A-7B illustrates the inner shaft 122 comprising a thermocouple wire 739 that is inserted through the third port 752b [0088, FIGS. 7A-7B]);
a third lumen offset from the first lumen and the exhaust lumen (figures 7A-7B illustrates the inner shaft 122 comprising a pressure monitoring lumen 772 that is offset from the supply lumen 732 and the exhaust lumen 750 [0085-0087, FIGS. 7A-7B]), the third lumen defining a dedicated fourth port (the pressure monitoring lumen 772 defines a fourth port 774 (e.g., pressure monitoring port) [0087, FIGS. 7A-7B]);
an expandable member enclosing the dedicated first, second, third, and fourth ports (figures 7A-7B illustrates the balloon 142 enclosing the first port 740, second port 752, third port 752b, and fourth port 774 [0084-0087, FIGS. 7A-7B]); and
wherein the dedicated first, second, third, and fourth ports are defined at different positions about the inner shaft (figures 7A-7B illustrates the first port 740, second port 752, third port 752b; and fourth port 774 being arranged at different positions along the shaft 122 [0085-0087, FIGS. 7A-7B]).
Clark does not explicitly teach wherein the dedicated first, second, third, and fourth ports are defined at different radial positions about the inner shaft;
wherein the dedicated third port is defined by a second lumen that is offset from the first lumen, exhaust lumen, and third lumen.
The prior art by Cheung is analogous to Clark, as they both teach a cryotherapy device comprising a shaft that is coupled to a balloon ([abstract, 0023, 0032]).
Cheung teaches wherein the dedicated first, second, third, and fourth ports are defined at different radial positions about the inner shaft (figures 4-5 illustrates the shaft 20 comprising an inner layer 39 having three or more protruding lumens 35 that are disposed at different radial positions [0029, 0032, 0039, FIGS. 4-5]. Specifically, each of the protruding lumens 35 extends along the entire length of the shaft 20 [0029]. Furthermore, figure 4 illustrates each of the protruding lumens 35 defining an end portion having a rounded opening (e.g., port) to receive the one or more conduits 36 [0029, 0032, FIG. 4]);
wherein the dedicated third port is defined by a second lumen that is offset from the first lumen, exhaust lumen, and third lumen (as stated previously above, figure 4 illustrates each of the protruding lumens 35 defining an end portion having a rounded opening (e.g., port) to receive the one or more conduits 36 (e.g., fluid supply conduits, fluid vacuum conduits, pressure monitoring conduits, and wire sensing conduits) [0029, 0032, 0043, 0045, FIGS. 4-5]. Specifically, figure 4 illustrates protruding lumens 35 being offset from each other [FIG. 4]. The Examiner respectfully submits that three or more protruding lumens 35 extend throughout the length of the of the shaft 20 [0029]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify each of Clark’s ports to be disposed at different radial positions, as taught by Cheung. The advantage of such modification will allow each of the ports to be in fluid communication (e.g., supplying fluid, vacuuming fluid, or pressure sensing) with different portions of the catheter shaft (see paragraphs [0029, 0032, 0043, 0045] by Cheung). Furthermore, it would have been obvious to a person having ordinary skill in the art to modify Clark’s dedicated third port that is defined by a second lumen that is offset from the first lumen, exhaust lumen, and third lumen. The advantage of such modification, as the lumen will provide an isolated pathway to the guide sensors or sensing wires through the opening of the third port and into the balloon assembly (see paragraphs [0032, 0043] by Cheung).
Regarding claim 2, Clark teaches an inflow tube affixed within the first lumen (figures 1 and 7A illustrates the supply line 110 delivering the refrigerant 106 through the shaft 122 and into the supply lumen 732 [0040, 0090, FIG. 1, FIG. 7A]).
Alternatively, Cheung teaches an inflow tube affixed within the first lumen (as stated previously in claim 1, each of the protruding lumens 35 extends along the entire length of the shaft 20 [0029]. Furthermore, the one or more conduits 36 may extend through each of the protruding lumens 35 [0029, 0032, 0043, FIGS. 4-5]. The Examiner respectfully submits that fluid may be supplied through the one or more conduits 36 [0032, 0043, FIGS. 4-5]).
Regarding claim 3, Clark teaches wherein the first lumen is closed at a position distal to the dedicated first port and proximal to a distal end of the inner shaft (figures 7A-7B illustrates the supply lumen 732 comprising a closed portion (e.g., outer wall of the lumen) that is disposed at a position distal to the first port 740 (e.g., inflow port) [0085, FIGS. 7A-7B]. Furthermore, figures 7A-7B illustrates the closed portion (e.g., outer wall) of the supply lumen 732 being arranged proximal to a distal end of the shaft 122 [FIGS. 7A-7B]).
Regarding claim 4, Clark teaches wherein the exhaust lumen is closed at a position distal to the dedicated second port and proximal to a distal end of the inner shaft (figures 7A-7B illustrates the exhaust passage or lumen 750 comprising a closed portion (e.g., outer wall of the lumen) that is disposed at a position distal to the second port 752 (e.g., exhaust port) [0085-0086, FIGS. 7A-7B]. Furthermore, figures 7A-7B illustrates the closed portion (e.g., outer wall) of the exhaust passage or lumen 750 being arranged proximal to a distal end of the shaft 122 [FIGS. 7A-7B]).
Regarding claim 5, Clark in view of Cheung suggests the device of claim 1, further including a thermocouple wire affixed within the second lumen (Clark teaches figures 7A-7B illustrating the inner shaft 122 comprising a thermocouple wire 739 that is inserted through the third port 752b [0088, FIGS. 7A-7B]. Meanwhile, Cheung teaches the sensing wires to be contained within a lumen of the one or conduits 36 which extends through the opening (e.g., port) of protrusions 35 [0029, 0032, FIGS. 4-5]).
Regarding claim 6, Cheung teaches wherein the second lumen is closed at a position distal to the dedicated third port and proximal to a distal end of the inner shaft (as stated previously in claim 1, figure 4 illustrates each of the protruding lumens 35 defining an end portion having a rounded opening (e.g., port) to receive the one or more conduits 36 [0029, 0032, 0043, 0045, FIGS. 4-5]. However, figure 4 also illustrates the protruding lumens 35 having a closed portion (e.g., wall) that is positioned distal to rounded openings (e.g., ports) [FIG. 4]. Furthermore, the protruding lumens 35 may extend along a desired length of the shaft 20 [0029, 0032, FIGS. 4-5]. This would allow the closed portion (e.g., wall) of the protruding lumens 35 to be arranged proximally to a distal end of the shaft 20 [0029, FIGS. 4-5]).
Regarding claim 7, Clark teaches a pressure monitoring tube affixed within the third lumen (the pressure monitoring lumen 772 may be coupled to a pressure sensor 105 via the pressure tube or line 107 [0042, 0069, 0087, FIG. 1, FIG. 7A]. For example, figures 1 and 7A illustrates the sensor 105 comprising a pressure tube or line 107 that is delivered through the shaft 122 to couple with pressure monitoring lumen 772 [0042, 0084, 0087, FIG. 1, FIG. 7A]).
Alternatively, Cheung teaches a pressure monitoring tube affixed within the third lumen (figure 4 illustrates each of the protruding lumens 35 defining an end portion having a rounded opening (e.g., port) to receive the one or more conduits 36 (e.g., pressure monitoring conduit) [0029, 0032, 0043, 0045, FIGS. 4-5]).
Regarding claim 8, Clark teaches wherein the third lumen is closed at a position distal to the dedicated fourth port and proximal to a distal end of the inner shaft (figures 7A-7B illustrates the pressure monitoring lumen 772 comprising a closed portion (e.g., outer wall of the lumen) that is disposed at a position distal to the fourth port 772 (e.g., pressure monitoring port) [0087, FIGS. 7A-7B]. Furthermore, figures 7A-7B illustrates the closed portion (e.g., outer wall) of the pressure monitoring lumen 772 being arranged proximal to a distal end of the shaft 122 [FIGS. 7A-7B]).
Regarding claim 9, Clark teaches wherein the inflow tube extends outward from the dedicated first port (figures 7B illustrates the supply lumen 732 extending outward from the first port 740 (e.g., inflow port) [0085, FIGS. 7A-7B]).
Regarding claim 10, Clark teaches wherein the dedicated first, second, third, and fourth ports are defined at different longitudinal positions about the inner shaft (figures 7A-7B illustrates the first port 740, second port 752, third port 752b; and fourth port 774 being arranged at different positions along the shaft 122 [0085-0087, FIGS. 7A-7B]).
Regarding claim 11, Clark teaches a medical device (cryotherapeutic device 120 [abstract]), comprising:
an elongate shaft (figure 2-3 illustrates the cryotherapeutic device 120 comprising an elongate shaft or sheath 154 [0039, 0052, FIGS. 2-3]);
an inner shaft disposed within the elongate shaft (the inner shaft 122 is disposed within the sheath 154 [0052, FIGS. 2-3]), the inner shaft defining:
a first lumen defining a dedicated first port (figures 7A-7B illustrates the inner shaft 122 comprising a supply lumen 732 that defines a first port 740 (e.g., inflow port) [0085, FIGS. 7A-7B]);
an exhaust lumen offset and fluidly isolated from the first lumen (figures 7A-7B illustrates the inner shaft 122 comprising an exhaust passage or lumen 750 being offset and isolated from the supply lumen 732 [0085-0086, FIGS. 7A-7B]) and defining a dedicated second port (the exhaust passage or lumen 750 defines the second port 752 (e.g., exhaust port) [0085-0086, FIGS. 7A-7B]);
a thermocouple wire that is inserted through a dedicated third port (figures 7A-7B illustrates the inner shaft 122 comprising a thermocouple wire 739 that is inserted through the third port 752b [0088, FIGS. 7A-7B]);
a third lumen offset and isolated from the first lumen and the exhaust lumen (figures 7A-7B illustrates the inner shaft 122 comprising a pressure monitoring lumen 772 that is offset from the supply lumen 732 and the exhaust lumen 750 [0085-0087, FIGS. 7A-7B]), the third lumen sized to receive a pressure monitoring tube and defining a dedicated fourth port (the pressure monitoring lumen 772 defines a fourth port 774 (e.g., pressure monitoring port) [0087, FIGS. 7A-7B]. Specifically, the pressure monitoring lumen 772 may be coupled to a pressure sensor 105 via the pressure tube or line 107 [0042, 0069, 0087, FIG. 1, FIG. 7A]. For example, figures 1 and 7A illustrates the sensor 105 comprising the pressure tube or line 107 that is delivered through the shaft 122 to couple with pressure monitoring lumen 772 [0042, 0084, 0087, FIG. 1, FIG. 7A]); and
an expandable member enclosing the dedicated first, second, third, and fourth ports (figures 7A-7B illustrates the balloon 142 enclosing the first port 740, second port 752, third port 752b, and fourth port 774 [0084-0087, FIGS. 7A-7B]).
Clark does not explicitly teach wherein the dedicated third port is defined by a second lumen that is offset and fluidly isolated from the first lumen, exhaust lumen, and third lumen; and
wherein the second lumen is configured to receive thermocouple wire.
The prior art by Cheung is analogous to Clark, as they both teach a cryotherapy device comprising a shaft that is coupled to a balloon ([abstract, 0023, 0032]).
Cheung teaches wherein the dedicated third port is defined by a second lumen that is offset and fluidly isolated from the first lumen, exhaust lumen, and third lumen (figure 4 illustrates each of the protruding lumens 35 defining an end portion having a rounded opening (e.g., port) to receive the one or more conduits 36 (e.g., fluid supply conduits, fluid vacuum conduits, pressure monitoring conduits, and wire sensing conduits) [0029, 0032, 0043, 0045, FIGS. 4-5]. Specifically, figure 4 illustrates protruding lumens 35 being offset and isolated from each other [FIG. 4]. The Examiner respectfully submits that three or more protruding lumens 35 extend throughout the length of the of the shaft 20 [0029]); and
Clark and Cheung suggest wherein the second lumen is configured to receive thermocouple wire (Clark teaches figures 7A-7B illustrating the inner shaft 122 comprising a thermocouple wire 739 that is inserted through the third port 752b [0088, FIGS. 7A-7B]. Meanwhile, Cheung teaches the sensing wires to be contained within a lumen of the one or conduits 36 which extends through the opening (e.g., port) of protrusions 35 [0029, 0032, FIGS. 4-5]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify each of Clark’s dedicated third port that is defined by a second lumen that is offset and fluidly isolated from the first lumen, exhaust lumen, and third lumen. The advantage of such modification, as the lumen will provide an isolated pathway to the guide sensors or sensing wires through the opening of the third port and into the balloon assembly (see paragraphs [0032, 0043] by Cheung). Furthermore, it would have been obvious to a person having ordinary skill in the art to modify Clark’s thermocouple wire to be disposed within the second lumen, as further suggested by Cheung. This modification is beneficial, as the lumen will provide an isolated pathway for the thermocouple or temperature sensing wire (see paragraph [0032] by Cheung).
Regarding claim 12, Clark teaches an inflow tube affixed within the first lumen (figures 1 and 7A illustrates the supply line 110 delivering the refrigerant 106 through the shaft 122 and into the supply lumen 732 [0040, 0090, FIG. 1, FIG. 7A]).
Alternatively, Cheung teaches an inflow tube affixed within the first lumen (as stated previously in claim 1, each of the protruding lumens 35 extends along the entire length of the shaft 20 [0029]. Furthermore, the one or more conduits 36 may extend through each of the protruding lumens 35 [0029, 0032, 0043, FIGS. 4-5]. The Examiner respectfully submits that fluid may be supplied through the one or more conduits 36 [0032, 0043, FIGS. 4-5]).
Regarding claim 13, Clark teaches wherein the first lumen is closed at a position distal to the dedicated first port and proximal to a distal end of the inner shaft (figures 7A-7B illustrates the supply lumen 732 comprising a closed portion (e.g., outer wall of the lumen) that is disposed at a position distal to the first port 740 (e.g., inflow port) [0085, FIGS. 7A-7B]. Furthermore, figures 7A-7B illustrates the closed portion (e.g., outer wall) of the supply lumen 732 being arranged proximal to a distal end of the shaft 122 [FIGS. 7A-7B]).
Regarding claim 14, Clark teaches wherein the exhaust lumen is closed at a position distal to the dedicated second port and proximal to a distal end of the inner shaft (figures 7A-7B illustrates the exhaust passage or lumen 750 comprising a closed portion (e.g., outer wall of the lumen) that is disposed at a position distal to the second port 752 (e.g., exhaust port) [0085-0086, FIGS. 7A-7B]. Furthermore, figures 7A-7B illustrates the closed portion (e.g., outer wall) of the exhaust passage or lumen 750 being arranged proximal to a distal end of the shaft 122 [FIGS. 7A-7B]).
Regarding claim 15, Clark in view of Cheung suggests the device of claim 11. Clark and Cheung suggest wherein the thermocouple wire is affixed within the second lumen (Clark teaches figures 7A-7B illustrating the inner shaft 122 comprising a thermocouple wire 739 that is inserted through the third port 752b [0088, FIGS. 7A-7B]. Meanwhile, Cheung teaches the sensing wires to be contained within a lumen of the one or conduits 36 which extends through the opening (e.g., port) of protrusions 35 [0029, 0032, FIGS. 4-5]); and
Cheung teaches wherein optionally the second lumen is closed at a position distal to the dedicated third port and proximal to a distal end of the inner shaft (as stated previously in claim 11, figure 4 illustrates each of the protruding lumens 35 defining an end portion having a rounded opening (e.g., port) to receive the one or more conduits 36 [0029, 0032, 0043, 0045, FIGS. 4-5]. However, figure 4 also illustrates the protruding lumens 35 having a closed portion (e.g., wall) that is positioned distal to rounded openings (e.g., ports) [FIG. 4]. Furthermore, the protruding lumens 35 may extend along a desired length of the shaft 20 [0029, 0032, FIGS. 4-5]. This would allow the closed portion (e.g., wall) of the protruding lumens 35 to be arranged proximally to a distal end of the shaft 20 [0029, FIGS. 4-5]).
Regarding claim 16, Clark teaches the pressure monitoring tube affixed within the third lumen (the pressure monitoring lumen 772 may be coupled to a pressure sensor 105 via the pressure tube or line 107 [0042, 0069, 0087, FIG. 1, FIG. 7A]. For example, figures 1 and 7A illustrates the sensor 105 comprising a pressure tube or line 107 that is delivered through the shaft 122 to couple with pressure monitoring lumen 772 [0042, 0084, 0087, FIG. 1, FIG. 7A]).
Alternatively, Cheung teaches the pressure monitoring tube affixed within the third lumen (figure 4 illustrates each of the protruding lumens 35 defining an end portion having a rounded opening (e.g., port) to receive the one or more conduits 36 (e.g., pressure monitoring conduit) [0029, 0032, 0043, 0045, FIGS. 4-5]).
Regarding claim 17, Cheung teaches wherein the dedicated first, second, third, and fourth ports are defined at different radial positions about the inner shaft (figures 4-5 illustrates the shaft 20 comprising an inner layer 39 having three or more protruding lumens 35 that are disposed at different radial positions [0029, 0032, 0039, FIGS. 4-5]. Specifically, each of the protruding lumens 35 extends along the entire length of the shaft 20 [0029]. Furthermore, figure 4 illustrates each of the protruding lumens 35 defining an end portion having a rounded opening (e.g., port) to receive the one or more conduits 36 [0029, 0032, FIG. 4]).
Regarding claim 18, Clark teaches a medical device (cryotherapeutic device 120 [abstract]), comprising:
an elongate shaft (figure 2-3 illustrates the cryotherapeutic device 120 comprising an elongate shaft or sheath 154 [0039, 0052, FIGS. 2-3]);
an inner shaft disposed within the elongate shaft (the inner shaft 122 is disposed within the sheath 154 [0052, FIGS. 2-3]), the inner shaft defining:
a first lumen sized to receive an inflow tube and defining a dedicated first port (figures 7A-7B illustrates the inner shaft 122 comprising a supply lumen 732 that defines a first port 740 (e.g., inflow port) [0085, FIGS. 7A-7B]. Furthermore, figures 1 and 7A illustrates the supply line 110 delivering the refrigerant 106 through the shaft 122 and into the supply lumen 732 [0040, 0090, FIG. 1, FIG. 7A]);
an exhaust lumen offset and fluidly isolated from the first lumen (figures 7A-7B illustrates the inner shaft 122 comprising an exhaust passage or lumen 750 being offset and isolated from the supply lumen 732 [0085-0086, FIGS. 7A-7B]) and defining a dedicated second port (the exhaust passage or lumen 750 defines the second port 752 (e.g., exhaust port) [0085-0086, FIGS. 7A-7B]);
a thermocouple wire that is inserted through a dedicated third port (figures 7A-7B illustrates the inner shaft 122 comprising a thermocouple wire 739 that is inserted through the third port 752b [0088, FIGS. 7A-7B]);
a third lumen offset and isolated from the first lumen and the exhaust lumen (figures 7A-7B illustrates the inner shaft 122 comprising a pressure monitoring lumen 772 that is offset from the supply lumen 732 and the exhaust lumen 750 [0085-0087, FIGS. 7A-7B]), the third lumen sized to receive a pressure monitoring tube and defining a dedicated fourth port (the pressure monitoring lumen 772 defines a fourth port 774 (e.g., pressure monitoring port) [0087, FIGS. 7A-7B]. Specifically, the pressure monitoring lumen 772 may be coupled to a pressure sensor 105 via the pressure tube or line 107 [0042, 0069, 0087, FIG. 1, FIG. 7A]), the pressure monitoring tube affixed within the third lumen (figures 1 and 7A illustrates the sensor 105 comprising a pressure tube or line 107 that is delivered through the shaft 122 to couple with pressure monitoring lumen 772 [0042, 0084, 0087, FIG. 1, FIG. 7A]); and
an expandable member enclosing the dedicated first, second, third, and fourth ports (figures 7A-7B illustrates the balloon 142 enclosing the first port 740, second port 752, third port 752b, and fourth port 774 [0084-0087, FIGS. 7A-7B]) and distal ends of the inflow tube, thermocouple wire, and pressure monitoring tube (figures 1 and 7A illustrates the supply line 110 delivering the refrigerant 106 through the shaft 122 and into the supply lumen 732 which is enclosed by the balloon 142 [0040, 0084-0085, 0090, FIG. 1, FIG. 7A]. Furthermore, figures 7A-7B illustrates thermocouple wire 739 being enclosed by the balloon 142 [FIGS. 7A-7B]. Furthermore, figures 1 and 7A illustrates the sensor 105 comprising a pressure tube or line 107 that is delivered through the shaft 122 to couple with pressure monitoring lumen 772 that is enclosed by the balloon 142 [0042, 0084, 0087, FIG. 1, FIG. 7A])
Clark does not explicitly teach wherein the dedicated third port is defined by a second lumen that is offset and fluidly isolated from the first lumen, exhaust lumen, and third lumen; and
wherein the second lumen is configured to receive thermocouple wire, and wherein the thermocouple wire is affixed to the second lumen.
The prior art by Cheung is analogous to Clark, as they both teach a cryotherapy device comprising a shaft that is coupled to a balloon ([abstract, 0023, 0032]).
Cheung teaches wherein the dedicated third port is defined by a second lumen that is offset and fluidly isolated from the first lumen, exhaust lumen, and third lumen (figure 4 illustrates each of the protruding lumens 35 defining an end portion having a rounded opening (e.g., port) to receive the one or more conduits 36 (e.g., fluid supply conduits, fluid vacuum conduits, pressure monitoring conduits, and wire sensing conduits) [0029, 0032, 0043, 0045, FIGS. 4-5]. Specifically, figure 4 illustrates protruding lumens 35 being offset and isolated from each other [FIG. 4]. The Examiner respectfully submits that three or more protruding lumens 35 extend throughout the length of the of the shaft 20 [0029]); and
Clark and Cheung suggest wherein the second lumen is configured to receive thermocouple wire, and wherein the thermocouple wire is affixed to the second lumen (Clark teaches figures 7A-7B illustrating the inner shaft 122 comprising a thermocouple wire 739 that is inserted through the third port 752b [0088, FIGS. 7A-7B]. Meanwhile, Cheung teaches the sensing wires to be contained within a lumen of the one or conduits 36 which extends through the opening (e.g., port) of protrusions 35 [0029, 0032, FIGS. 4-5]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify each of Clark’s dedicated third port that is defined by a second lumen that is offset and fluidly isolated from the first lumen, exhaust lumen, and third lumen. The advantage of such modification, as the lumen will provide an isolated pathway to the guide sensors or sensing wires through the opening of the third port and into the balloon assembly (see paragraphs [0032, 0043] by Cheung). Furthermore, it would have been obvious to a person having ordinary skill in the art to modify Clark’s thermocouple wire to be disposed within the second lumen, as further suggested by Cheung. This modification is beneficial, as the lumen will provide an isolated pathway for the thermocouple or temperature sensing wire (see paragraph [0032] by Cheung).
Regarding claim 19, Clark teaches a medical device (cryotherapeutic device 120 [abstract]), comprising:
an elongate shaft (figure 2-3 illustrates the cryotherapeutic device 120 comprising an elongate shaft or sheath 154 [0039, 0052, FIGS. 2-3]);
an inner shaft disposed within the elongate shaft (the inner shaft 122 is disposed within the sheath 154 [0052, FIGS. 2-3]), the inner shaft including a rigid hub extending from a distal end of the inner shaft (figure 7A illustrates the rigid cooling hub assembly 730 extending from a distal end of the shaft 122 [0089, FIG. 7A]), the hub defining
a first lumen defining a dedicated first port (figures 7A-7B illustrates the rigid cooling hub assembly 730 of the inner shaft 122 comprising a supply lumen 732 that defines a first port 740 (e.g., inflow port) [0085, FIGS. 7A-7B]);
an exhaust lumen offset from the first lumen (figures 7A-7B illustrates the rigid cooling hub assembly 730 of the inner shaft 122 comprising an exhaust passage or lumen 750 being offset from the supply lumen 732 [0085-0086, FIGS. 7A-7B]) and defining a dedicated second port (the exhaust passage or lumen 750 defines the second port 752 (e.g., exhaust port) [0085-0086, FIGS. 7A-7B]);
a dedicated third port (figures 7A-7B illustrates the rigid cooling hub assembly 730 of the inner shaft 122 comprising a thermocouple wire 739 that is inserted through the third port 752b [0088, FIGS. 7A-7B]);
a third lumen offset from the first lumen and the exhaust lumen (figures 7A-7B illustrates the rigid cooling hub assembly 730 of the inner shaft 122 comprising a pressure monitoring lumen 772 that is offset from the supply lumen 732 and the exhaust lumen 750 [0085-0087, FIGS. 7A-7B]), the third lumen defining a dedicated fourth port (the pressure monitoring lumen 772 defines a fourth port 774 (e.g., pressure monitoring port) [0087, FIGS. 7A-7B]);
an expandable member enclosing the dedicated first, second, third, and fourth ports (figures 7A-7B illustrates the rigid cooling hub assembly 730 comprising a balloon 142 that encloses the first port 740, second port 752, third port 752b, and fourth port 774 [0084-0087, FIGS. 7A-7B]); and
wherein the dedicated first, second, third, and fourth ports are defined at different positions about the inner shaft (figures 7A-7B illustrates the first port 740, second port 752, third port 752b; and fourth port 774 being arranged at different positions along the shaft 122 [0085-0087, FIGS. 7A-7B]).
Clark does not explicitly teach wherein the dedicated first, second, third, and fourth ports are defined at different radial positions about the inner shaft;
wherein the dedicated third port is defined by a second lumen that is offset from the first lumen, exhaust lumen, and third lumen.
The prior art by Cheung is analogous to Clark, as they both teach a cryotherapy device comprising a shaft that is coupled to a balloon ([abstract, 0023, 0032]).
Cheung teaches wherein the dedicated first, second, third, and fourth ports are defined at different radial positions about the inner shaft (figures 4-5 illustrates the shaft 20 comprising an inner layer 39 having three or more protruding lumens 35 that are disposed at different radial positions [0029, 0032, 0039, FIGS. 4-5]. Specifically, each of the protruding lumens 35 extends along the entire length of the shaft 20 [0029]. Furthermore, figure 4 illustrates each of the protruding lumens 35 defining an end portion having a rounded opening (e.g., port) to receive the one or more conduits 36 [0029, 0032, FIG. 4]);
wherein the dedicated third port is defined by a second lumen that is offset from the first lumen, exhaust lumen, and third lumen (as stated previously above, figure 4 illustrates each of the protruding lumens 35 defining an end portion having a rounded opening (e.g., port) to receive the one or more conduits 36 (e.g., fluid supply conduits, fluid vacuum conduits, pressure monitoring conduits, and wire sensing conduits) [0029, 0032, 0043, 0045, FIGS. 4-5]. Specifically, figure 4 illustrates protruding lumens 35 being offset from each other [FIG. 4]. The Examiner respectfully submits that three or more protruding lumens 35 extend throughout the length of the of the shaft 20 [0029]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify each of Clark’s ports to be disposed at different radial positions, as taught by Cheung. The advantage of such modification will allow each of the ports to be in fluid communication (e.g., supplying fluid, vacuuming fluid, or pressure sensing) with different portions of the catheter shaft (see paragraphs [0029, 0032, 0043, 0045] by Cheung). Furthermore, it would have been obvious to a person having ordinary skill in the art to modify Clark’s dedicated third port that is defined by a second lumen that is offset from the first lumen, exhaust lumen, and third lumen. The advantage of such modification, as the lumen will provide an isolated pathway to the guide sensors or sensing wires through the opening of the third port and into the balloon assembly (see paragraphs [0032, 0043] by Cheung).
Statement on Communication via Internet
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Conclusion
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
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/J.B.S./Examiner, Art Unit 3792
/ANKIT D TEJANI/Primary Examiner, Art Unit 3796