DETAILED ACTION
1. This office action is in response to the communicated dated 15 April 2026 concerning application number 18/573,532 effectively filed on 22 December 2023.
Notice of Pre-AIA or AIA Status
2. 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.
Status of Claims
3. Claims 1-20 are pending, of which claim 20 has been added; claims 1, 9-11, 15-16, and 18-19 have been amended; and claims 1-20 are under consideration for patentability.
Response to Arguments
4. Applicant’s arguments dated 15 April 2026, referred to herein as “the Arguments, have been fully considered but they are not persuasive in view of the new grounds of rejection necessitated by Applicant’s amendments to the claims.
The Examiner has addressed amended limitations within the updated text below.
Regarding claim 1, Applicant argues that Clark does not explicitly suggests the amended limitation that recites the four different ports being associated with four separate lumens, with each port extending radially through an outer wall of the shaft, and the four ports being at different radial positions about the inner shaft (pages 9-11 of the Arguments). The Examiner has provided a new ground of rejection that introduces the prior art by Tun (US 8,790,300 B2) to address the amendment that recites each of the ports extending radially through an outer wall of the shaft. However, the Examiner respectfully submits that Clark was not relied upon for teaching each of the claimed arrangements. Specifically, Clark was relied upon for teaching an inner shaft 122 comprising a first lumen 732 (e.g., supply lumen) defining a dedicated first port 740 ([0085, FIGS. 7A-7B]), an exhaust lumen 750 defining a dedicated second port 752 ([0085-0086, FIGS. 7A-7B]), and a third lumen 772 defining a dedicated fourth port 774 (e.g., pressure monitoring port) [0087, FIGS. 7A-7B]). The Examiner further submits that Clark teaches the inner shaft 122 comprising a dedicated third port 752b that allows for the insertion of a thermocouple wire 739 ([0088, FIGS. 7A-7B]). However, the Examiner acknowledged that Clark did not explicitly teach the wherein dedicated third port is defined by a second lumen that is offset from the first lumen, exhaust lumen, and the third lumen. Furthermore, the Examiner acknowledged that Clark did not explicitly teach wherein the dedicated first, second, third, and fourth ports are defined at different radial positions about the inner shaft. Thus, the Examiner introduced Cheung to teach the third port being defined by a second lumen that is offset from the first lumen, exhaust lumen, and third lumen (figure 4 illustrates an offset arrangement of protruding lumens 35 that define 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]). Cheung also teaches the dedicated first, second, third, and fourth port being defined at different radial positions about the inner shaft (figure 4 illustrates the shaft 20 comprising an inner layer 39 having three or more protruding lumens 35 defining rounded openings (e.g., ports) that are disposed at different radial positions [0029, 0032, 0039, FIGS. 4-5]). Therefore, the Examiner respectfully submits that maintains that Clark and Cheung suggest four different ports associated with four separate lumens and the four ports being at different radial positions about the inner shaft. As stated previously above, the new ground of rejection introduces the prior art by Tun to address the amended limitation that recites each of the ports extending radially through an outer wall of the shaft.
Regarding claim 10, Applicant argues that the prior art of record does not explicitly suggest wherein the dedicated first, second, and fourth ports are defined at different longitudinal positions along the inner shaft (page 11 of the Arguments). The Examiner respectfully disagrees, Clark illustrates the first port 740, second port 752, third port 752b, and fourth port 774 being arranged at different longitudinal or axial positions along the shaft 122 ([FIGS. 7A-7B]). Therefore, the Examiner respectfully maintains that Clark suggests wherein the dedicated first, second, and fourth ports are defined at different longitudinal positions along the inner shaft.
Regarding claim 11, Applicant argues that the prior art of record does not explicitly teach the amended limitation that recites wherein the first lumen is defined by a first inner wall within the inner shaft and wherein the exhaust lumen is defined by a second inner wall within the inner shaft. Furthermore, Applicant states the prior art of record does not explicitly teach the amended limitation that recites wherein the second inner wall is spaced from the first inner wall (pages 11-13 of the Arguments). The Examiner has addressed the amended limitation within the new grounds of rejection presented below.
Regarding claim 18, Applicant argues that the prior art of record does not explicitly teach the amended limitation that recites the fourth port extending radially through the outer wall of the inner shaft (pages 14-15 of the Arguments). The Examiner has addressed the amened limitation within the new grounds of rejection presented below.
Regarding claim 19, Applicant argues that the limitations of claim 19 are patentable for the same reasons that were described in claim 1 above. For example, Applicant argues that the prior art of record does not explicitly suggests the claimed arrangement of the offset lumens and their associated ports, with the four ports being defined at different radial positions (pages 16-17 of the Arguments). The Examiner respectfully submits that this argument was previously addressed in claim 1 (see the arguments for claim 1 above). Thus, the Examiner respectfully maintains that Clark and Cheung suggest the claimed arrangement of the offset lumens and their associated ports, with the four ports being defined at different radial positions. However, the new ground of rejection introduces the prior art by Tun to address the amended limitation that recites each of the ports extending radially through an outer wall of the hub.
Claim Rejections - 35 USC § 103
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1-20 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) and Tun et al. (US Patent No. 8,790,300 B2).
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 having an outer wall (figures 2 and 7A-7B illustrates the shaft 122 having an outer wall or surface [FIG. 2, FIGS. 7A-7B]) and 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; and
wherein the dedicated first port, the dedicated second port, the dedicated third port, and the dedicated fourth port extend radially through the outer wall of the inner shaft.
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]).
The prior art by Tun is analogous to Clark, as they both teach a catheter comprising a balloon or expandable member ([abstract]).
Tun teaches wherein the dedicated first port, the dedicated second port, the dedicated third port, and the dedicated fourth port extend radially through the outer wall of the inner shaft (figure 1 illustrates the balloon catheter 10 comprising an elongated inner shaft 12 that extends through the delivery sheath 26 (e.g., outer shaft) [column 2 lines 55-60, column 4 lines 23-35, FIG. 1]. Specifically, the elongated inner shaft 12 comprises tubular members 44 and 46 [column 5 lines 25-27, column 6 lines 21-63, FIGS. 1-2]. Furthermore, the conduits 61-62 and/or other conduits (e.g., supply lumen, exhaust lumen, pressure sensing lumen, temperature sensing lumen, and other lumens) includes respective openings or ports that extend radially through the outer wall of the tubular member 44 to provide fluid communication with the balloons 21 and 23 [column 6 lines 21-63, claim 17]. As stated previously above, the tubular members 44 and 46 are components of the elongated inner shaft 12 which extends through the delivery sheath 26 (e.g., outer shaft) [FIGS. 1-2, column 2 lines 55-60, column 4 lines 23-35, column 5 lines 25-27, column 6 lines 21-63]).
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). Lastly, it would have been obvious to a person having ordinary skill in the art to modify each of the dedicated ports suggested by Clark in view of Cheung to extend radially through the outer wall of the inner shaft, as taught by Tun. This modification is beneficial, as each of the respective ports or openings of the conduits (e.g., supply lumen, exhaust lumen, pressure sensing lumen, temperature sensing lumen, and/or other lumens) will extend radially through the outer wall of the tubular shaft to improve the fluid communication with the balloon (see [column 6 lines 21-63] and [claim 17] by Tun).
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 along 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 having an outer wall (figures 2 and 7A-7B illustrates the shaft 122 having an outer wall or surface [FIG. 2, FIGS. 7A-7B]) and 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;
wherein the second lumen is configured to receive thermocouple wire;
wherein the first lumen is defined by a first inner wall within the inner shaft; and
wherein the exhaust lumen is defined by a second inner wall within the inner shaft, wherein the second inner wall is spaced from the first inner wall.
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]).
The prior art by Tun is analogous to Clark, as they both teach a catheter comprising a balloon or expandable member ([abstract]).
Tun teaches wherein the first lumen is defined by a first inner wall within the inner shaft (figure 1 illustrates the balloon catheter 10 comprising an elongated inner shaft 12 that extends through the delivery sheath 26 (e.g., outer shaft) [column 2 lines 55-60, column 4 lines 23-35, FIG. 1]. Specifically, the elongated inner shaft 12 comprises the tubular member 44 [column 5 lines 25-27, column 6 lines 21-63, FIGS. 1-2]. Furthermore, figure 2 illustrates the conduit 60 (e.g., supply lumen) being formed along or within the first interior wall portion (e.g., right side) of the tubular member 44 [column 6 lines 21-50, FIG. 2]); and
wherein the exhaust lumen is defined by a second inner wall within the inner shaft, wherein the second inner wall is spaced from the first inner wall (figure 2 illustrates the conduit 62 (e.g., exhaust lumen) being formed along or within the second interior wall portion (e.g., left side) of the tubular member 44 [column 6 lines 21-50, FIG. 2]. As stated previously above, figure 2 illustrates the conduit 60 (e.g., supply lumen) being formed along or within the first interior wall portion (e.g., right side) of the tubular member 44 [column 6 lines 21-50, FIG. 2]. The Examiner respectfully submits that the first interior wall portion (e.g., right side) of the tubular member 44 is spaced from the second interior wall portion (e.g., left side) of the tubular member 44 [FIG. 2]).
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). Lastly, it would have been obvious to a person having ordinary skill in the art to modify Clark’s first lumen and second lumen to be respectively defined by a first inner wall and a second inner wall that are spaced apart, as further taught by Tun. The advantage of such modification will allow each of conduits (e.g., supply lumen and exhaust lumen) to communicate with different regions of the balloon (see [column 6 lines 21-50] by Tun).
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])
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 having an outer wall (figures 2 and 7A-7B illustrates the shaft 122 having an outer wall or surface [FIG. 2, FIGS. 7A-7B]) and 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;
wherein the second lumen is configured to receive thermocouple wire, and wherein the thermocouple wire is affixed to the second lumen; and
the dedicated fourth port extending radially through the outer wall of the inner shaft.
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]).
The prior art by Tun is analogous to Clark, as they both teach a catheter comprising a balloon or expandable member ([abstract]).
Tun teaches the dedicated fourth port extending radially through the outer wall of the inner shaft (figure 1 illustrates the balloon catheter 10 comprising an elongated inner shaft 12 that extends through the delivery sheath 26 (e.g., outer shaft) [column 2 lines 55-60, column 4 lines 23-35, FIG. 1]. Specifically, the elongated inner shaft 12 comprises tubular members 44 and 46 [column 5 lines 25-27, column 6 lines 21-63, FIGS. 1-2]. Furthermore, the conduits 61-62 and/or other conduits (e.g., supply lumen, exhaust lumen, pressure sensing lumen, temperature sensing lumen, and other lumens) includes respective openings or ports that extend radially through the outer wall of the tubular member 44 to provide fluid communication with the balloons 21 and 23 [column 6 lines 21-63, claim 17]. As stated previously above, the tubular members 44 and 46 are components of the elongated inner shaft 12 which extends through the delivery sheath 26 (e.g., outer shaft) [FIGS. 1-2, column 2 lines 55-60, column 4 lines 23-35, column 5 lines 25-27, column 6 lines 21-63]).
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). Lastly, it would have been obvious to a person having ordinary skill in the art to modify the fourth dedicated port suggested by Clark in view of Cheung to extend radially through the outer wall, as taught by Tun. This modification is beneficial, as the port or opening of the conduit (e.g., pressure sensing lumen) will extend radially through the outer wall to improve the fluid communication with the balloon (see [column 6 lines 21-63] and [claim 17] by Tun).
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 having an outer wall (figure 7A illustrates rigid cooling hub assembly 730 having an outer wall [FIG. 7A]) and 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; and
wherein the dedicated first port, the dedicated second port, the dedicated third port, and the dedicated fourth port extend radially through the outer wall of the hub.
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]); and
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]).
The prior art by Tun is analogous to Clark, as they both teach a catheter comprising a balloon or expandable member ([abstract]).
Tun teaches wherein the dedicated first port, the dedicated second port, the dedicated third port, and the dedicated fourth port extend radially through the outer wall of the hub (The Examiner respectfully submits that Applicant’s drawings illustrate the claimed rigid hub (e.g., rigid hub 70) to be a tubular member [FIG. 5]. Similarly, Tun teaches the distal end of the catheter shaft 12 comprising an outer tubular member 44 (e.g., hub) [column 6 lines 21-63, claim 17, FIG. 2]. Furthermore, the one or more conduits (e.g., supply lumen, exhaust lumen, pressure sensing lumen, temperature sensing lumen, and other lumens) includes respective openings or ports that extend radially through the outer wall of the outer tubular member 44 (e.g., hub) [column 5 lines 58-65, column 6 lines 21-63, claim 17]. Specifically, claim 17 recites that the one or more openings (e.g., ports) extends radially through the outer wall of the outer tubular member (e.g., hub) [claim 17])
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). Lastly, it would have been obvious to a person having ordinary skill in the art to modify each of the dedicated ports suggested by Clark in view of Cheung to extend radially through the outer wall of the hub, as taught by Tun. This modification is beneficial, as each of the respective ports or openings of the conduits (e.g., supply lumen, exhaust lumen, pressure sensing lumen, temperature sensing lumen, and/or other lumens) will extend radially through the outer wall of the hub (e.g., tubular member) to improve the fluid communication with the balloon (see [column 5 lines 58-65, column 6 lines 21-63] and [claim 17] by Tun).
Regarding claim 20, Clark in view of Cheung and Tun suggests the medical device of claim 1. Tun teaches wherein the first lumen is defined by a first inner wall within the inner shaft (figure 1 illustrates the balloon catheter 10 comprising an elongated inner shaft 12 that extends through the delivery sheath 26 (e.g., outer shaft) [column 2 lines 55-60, column 4 lines 23-35, FIG. 1]. Specifically, the elongated inner shaft 12 comprises the tubular member 44 [column 5 lines 25-27, column 6 lines 21-63, FIGS. 1-2]. Furthermore, figure 2 illustrates the conduit 60 (e.g., supply lumen) being formed along or within the first interior wall portion (e.g., right side) of the tubular member 44 [column 6 lines 21-50, FIG. 2]); and
wherein the exhaust lumen is defined by a second inner wall within the inner shaft, wherein the second inner wall is spaced from the first inner wall (figure 2 illustrates the conduit 62 (e.g., exhaust lumen) being formed along or within the second interior wall portion (e.g., left side) of the tubular member 44 [column 6 lines 21-50, FIG. 2]. As stated previously above, figure 2 illustrates the conduit 60 (e.g., supply lumen) being formed along or within the first interior wall portion (e.g., right side) of the tubular member 44 [column 6 lines 21-50, FIG. 2]. The Examiner respectfully submits that the first interior wall portion (e.g., right side) of the tubular member 44 is spaced from the second interior wall portion (e.g., left side) of the tubular member 44 [FIG. 2]).
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 Clark’s first lumen and second lumen to be respectively defined by a first inner wall and a second inner wall that are spaced apart, as further taught by Tun. The advantage of such modification will allow each of conduits (e.g., supply lumen and exhaust lumen) to communicate with different regions of the balloon (see [column 6 lines 21-50] by Tun).
Conclusion
7. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on (571)272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
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