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 .
Election/Restrictions
Applicant’s election without traverse of Species C (claims 1-43) in the reply filed on 03/05/2026 is acknowledged.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9, 12, 16, 27-35, 38, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Schaer et al. (WO 2021/108562; hereinafter Schaer), in view of Kong et al. (US 2013/0137955; hereinafter Kong).
Regarding claims 1 and 16, Schaer discloses a cable routing and assemblies for medical device handles. Schaer shows an ultrasound imaging tool (see par. [0006]) configured with rotation (see 1003 in fig. 1A; par. [0048]) and deflection control (see 1001 in fig. 1A; par. [0048]), the tool comprising: an ultrasound probe disposed adjacent a distal region of a rotatable shaft (see par. [0051], [0062] fig. 5); a deflectable shaft disposed relative to the rotatable shaft such that deflection of the deflectable shaft causes deflection of at least the distal region of the rotatable shaft (see fig. 1A and 2); and a handle assembly comprising a handle body with an outer surface that can be gripped by a user (see 1002 in fig. 1A; par. [0048]), a first actuator configured to be moved relative to the handle body (see 1003 in fig. 1A; par. [0048]), and a second actuator configured to be moved relative to the handle body (see 1001 in fig. 1A; par. [0048]), wherein the first actuator and the second actuator are circumferentially disposed about a longitudinal axis of the handle body (see 1001 and 1003 in fig. 1A), wherein the rotatable shaft is in operable communication with the first actuator of the handle assembly such that actuation of the first actuator causes rotational movement of at least the distal region of the rotatable shaft relative to the deflectable shaft (see par. [0048]), wherein the deflectable shaft is in operable communication with the second actuator such that rotation of the second actuator causes deflection of the deflectable shaft and thereby deflection of the rotatable shaft (see par. [0048]); and a plurality of pull wires (see 1104 in fig. 1B; par. [0050]) in communication with at least the second actuator and disposed along a longitudinal length of the deflectable shaft (see par. [0048], [0054]), the plurality of pull wires configured to one or more of converge or separate relative to each other to provide control over the deflection of the deflectable shaft (see par. [0048], [0054]; fig. 1B, 3Bii and 3Cii).
Furthermore, Schaer shows a flexible circuit board disposed adjacent the ultrasound transducer and in electrical communication with the ultrasound transducer (see par. [0063], [00064]; fig. 5, 6A-G, 13A), the flexible circuit board having a plurality of electrical component pads disposed thereon (see par. [0063], [00064]; fig. 5, 6A-G, 13A), and wherein the flexible circuit board is configured in a folded arrangement upon itself (see par. [0063], [0064], [0120], ; fig. 5, 6A-G, 13A), but fails to explicitly state wherein the folded arrangement of the flexible circuit board comprises at least four folds.
Kong teaches flexible circuit board with folded arranged with at least four Folds and M-fold configuration (see 8A and 14C). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized the teaching of flexible circuit board with folded arranged with at least four Folds and M-fold configuration in the invention of Schaer, as taught by Kong, to provide improved reliability and PCB with reduced space and weight.
Regarding claim 2, Schaer shows wherein the plurality of pull wires comprises four pull wires (see par. [0056], fig. 3Diiii).
Regarding claim 3, Schaer shows wherein the plurality of pull wire are configured to provide symmetric deflection of the deflectable shaft in at least two opposite direction curves (see fig. 1A).
Regarding claim 4, Schaer shows wherein the plurality of pull wire are configured to provide asymmetric deflection of the deflectable shaft in a first direction curve (see fig. 3Di and 3Dii) and a second direction curve opposite the first direction curve such that the first direct curve has a radius of curvature that is different from a radius of curvature of the second direction curve (see fig. 3Diii).
Regarding claim 5, Schaer shows wherein at least a pair of the plurality of pull wires are disposed adjacent each other in parallel configuration along the longitudinal length of the deflectable shaft from the handle assembly to a select bifurcation region disposed distally from the handle assembly (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E), wherein at least the pair of the plurality of pull wires are spaced further from each other in the bifurcation region than the handle assembly (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E), and the at least the pair of the plurality of pull wires are spaced closer to each other in a second region of the deflectable shaft disposed distally from the bifurcation region compared to the bifurcation region (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E).
Regarding claim 6, Schaer shows wherein at least a portion of the second region exhibits a stiffness that is less than a stiffness of the bifurcation region (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E; par. [0058], [0076]).
Regarding claim 7, Schaer shows wherein at least a first pair of the plurality of pull wires are disposed adjacent each other in parallel configuration along the longitudinal length of the deflectable shaft in a first region of the deflectable shaft to a select first bifurcation position disposed distally from the handle assembly (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E), wherein at least a second pair of the plurality of pull wires are disposed adjacent each other in parallel configuration along the longitudinal length of the deflectable shaft in a second region of the deflectable shaft to a select second bifurcation position disposed distally from the handle assembly (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E), and wherein at least the first pair of the plurality of pull wires are spaced further from each other in a third region disposed distally from the first bifurcation point and the second pair of the plurality of pull wires are spaced further from each other in a fourth region disposed distally from the second bifurcation point (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E).
Regarding claim 8, Schaer shows wherein a stiffness of the first region is different from a stiffness of the third region (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E; par. [0058], [0076]).
Regarding claim 9, Schaer shows wherein a stiffness of the second region is different from a stiffness of the fourth region (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E; par. [0058], [0076]).
Regarding claim 12, Schaer shows wherein the ultrasound probe comprises an ultrasound transducer at least partially enclosed by a material to define a distal tip of the ultrasound probe (see fig. 9B, 13A; par. [0112]).
Regarding claims 27 and 42, Schaer discloses a cable routing and assemblies for medical device handles. Schaer shows an ultrasound imaging tool (see par. [0006]) configured with rotation (see 1003 in fig. 1A; par. [0048]) and deflection control (see 1001 in fig. 1A; par. [0048]), the tool comprising: an ultrasound probe disposed adjacent a distal region of a rotatable shaft (see par. [0051], [0062] fig. 5); a deflectable shaft disposed relative to the rotatable shaft such that deflection of the deflectable shaft causes deflection of at least the distal tip region of the rotatable shaft (see fig. 1A and 2); and a handle assembly comprising a handle body with an outer surface that can be gripped by a user (see 1002 in fig. 1A; par. [0048]), a first actuator configured to be moved relative to the handle body (see 1003 in fig. 1A; par. [0048]), and a second actuator configured to be moved relative to the handle body (see 1001 in fig. 1A; par. [0048]); and a plurality of pull wires in communication with one or more of the first actuator or the second actuator (see 1104 in fig. 1B; par. [0050]), the plurality of pull wires disposed along a longitudinal length of the deflectable shaft and the rotatable shaft (see par. [0048], [0054]), wherein the rotatable shaft is in operable communication with the first actuator of the handle assembly via one or more first pull wires of the plurality of pull wires such that actuation of the first actuator causes rotational movement of at least the distal region of the rotatable shaft relative to the deflectable shaft (see par. [0048], [0054], [0056]), wherein the deflectable shaft is in operable communication with the second actuator via one or more second pull wires of the plurality of pull wires such that rotation of the second actuator causes deflection of the deflectable shaft and thereby deflection of the rotatable shaft (see par. [0048], [0054], [0056]), wherein one or more of the first actuator or the second actuator comprises a first helical gear disposed to rotate in response to rotation of the one or more of the first actuator or the second actuator (see par. [0086]; see 147 in fig. 10A), and wherein one or more of the first pull wires or the second pull wires is coupled to a spindle (see par. [0086]; see 148 or 149 in fig. 10A) having a second helical gear (see fig. 10A; par. [0086]) configured to engage the first helical gear such that rotation of the first helical gear causes rotation of the spindle to wind or unwind the one or more of the first pull wires or the second pull wires (see par. [0086]; fig. 10A).
Furthermore, Schaer shows a flexible circuit board disposed adjacent the ultrasound transducer and in electrical communication with the ultrasound transducer (see par. [0063], [00064]; fig. 5, 6A-G, 13A), the flexible circuit board having a plurality of electrical component pads disposed thereon (see par. [0063], [00064]; fig. 5, 6A-G, 13A), and wherein the flexible circuit board is configured in a folded arrangement upon itself (see par. [0063], [0064], [0120], ; fig. 5, 6A-G, 13A), but fails to explicitly state wherein the folded arrangement of the flexible circuit board comprises at least four folds.
Kong teaches flexible circuit board with folded arranged with at least four Folds and M-fold configuration (see 8A and 14C). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized the teaching of flexible circuit board with folded arranged with at least four Folds and M-fold configuration in the invention of Schaer, as taught by Kong, to provide improved reliability and PCB with reduced space and weight.
Regarding claim 28, Schaer shows wherein the plurality of pull wires comprises four pull wires (see par. [0056], fig. 3Diiii).
Regarding claim 29, Schaer shows wherein the plurality of pull wire are configured to provide symmetric deflection of the deflectable shaft in at least two opposite direction curves (see fig. 1A).
Regarding claim 30, Schaer shows wherein the plurality of pull wire are configured to provide asymmetric deflection of the deflectable shaft in a first direction curve (see fig. 3Di and 3Dii) and a second direction curve opposite the first direction curve such that the first direct curve has a radius of curvature that is different from a radius of curvature of the second direction curve (see fig. 3Diii).
Regarding claim 31, Schaer shows wherein at least a pair of the plurality of pull wires are disposed adjacent each other in parallel configuration along the longitudinal length of the deflectable shaft from the handle assembly to a select bifurcation region disposed distally from the handle assembly (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E), wherein at least the pair of the plurality of pull wires are spaced further from each other in the bifurcation region than the handle assembly (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E), and the at least the pair of the plurality of pull wires are spaced closer to each other in a second region of the deflectable shaft disposed distally from the bifurcation region compared to the bifurcation region (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E).
Regarding claim 32, Schaer shows wherein at least a portion of the second region exhibits a stiffness that is less than a stiffness of the bifurcation region (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E; par. [0058], [0076]).
Regarding claim 33, Schaer shows wherein at least a first pair of the plurality of pull wires are disposed adjacent each other in parallel configuration along the longitudinal length of the deflectable shaft in a first region of the deflectable shaft to a select first bifurcation position disposed distally from the handle assembly (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E), wherein at least a second pair of the plurality of pull wires are disposed adjacent each other in parallel configuration along the longitudinal length of the deflectable shaft in a second region of the deflectable shaft to a select second bifurcation position disposed distally from the handle assembly (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E), and wherein at least the first pair of the plurality of pull wires are spaced further from each other in a third region disposed distally from the first bifurcation point and the second pair of the plurality of pull wires are spaced further from each other in a fourth region disposed distally from the second bifurcation point (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E).
Regarding claim 34, Schaer shows wherein a stiffness of the first region is different from a stiffness of the third region (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E; par. [0058], [0076]).
Regarding claim 35, Schaer shows wherein a stiffness of the second region is different from a stiffness of the fourth region (see fig. 3Bi, 3Bii, 3Di, 3Diii and 3E; par. [0058], [0076]).
Regarding claim 38, Schaer shows wherein the ultrasound probe comprises an ultrasound transducer at least partially enclosed by a material to define a distal tip of the ultrasound probe (see fig. 9B, 13A; par. [0112]).
Claims 10-11 and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Schaer et al. (WO 2021/108562; hereinafter Schaer), in view of Kong et al. (US 2013/0137955; hereinafter Kong) as applied to claims 1 and 27 above, and further in view of Ziv-Ari et al. (US 2023/0218272; hereinafter Ziv-Ari).
Regarding claim 10, Schaer and Kong disclose the invention substantially as described in the 103 rejection above, but fails to explicitly state a dual axis sensor and a single axis sensor disposed in spaced relation relative to each other and configured to provide positional feedback indicative of one or more of a deflection or a rotation of the ultrasound probe.
Ziv-Ari discloses controlling and visualizing rotation and deflection of a 4D ultrasound catheter. Ziv-Ari shows a dual axis sensor and a single axis sensor disposed in spaced relation relative to each other (see par. [0054], [0055], [0057) and configured to provide positional feedback indicative of one or more of a deflection or a rotation of the ultrasound probe (see par. [0054], [0055], [0057).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of a dual axis sensor and a single axis sensor disposed in spaced relation relative to each other and configured to provide positional feedback indicative of one or more of a deflection or a rotation of the ultrasound probe in the invention of Schaer and Kong, as taught by Ziv-Ari, to be able to measure signal indictive to position and orientation of the shaft and distal end.
Regarding claim 11, Schaer, Kong and Ziv-Ari disclose the invention substantially as described in the 103 rejection above, furthermore, Ziv-Ari teaches wherein the dual axis sensor is disposed adjacent the ultrasound probe (see 52 in fig. 3B) and the single axis sensor is spaced proximally from the dual axis sensor along a longitudinal axis of the deflectable shaft (see 99 in fig. 3B). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the dual axis sensor is disposed adjacent the ultrasound probe and the single axis sensor is spaced proximally from the dual axis sensor along a longitudinal axis of the deflectable shaft in the invention of Schaer and Kong, as taught by Ziv-Ari, to be able to measure signa indictive to position and orientation of the shaft and distal end for two different dedicated sensors.
Regarding claim 36, Schaer and Kong disclose the invention substantially as described in the 103 rejection above, but fails to explicitly state a dual axis sensor and a single axis sensor disposed in spaced relation relative to each other and configured to provide positional feedback indicative of one or more of a deflection or a rotation of the ultrasound probe.
Ziv-Ari discloses controlling and visualizing rotation and deflection of a 4D ultrasound catheter. Ziv-Ari shows a dual axis sensor and a single axis sensor disposed in spaced relation relative to each other (see par. [0054], [0055], [0057) and configured to provide positional feedback indicative of one or more of a deflection or a rotation of the ultrasound probe (see par. [0054], [0055], [0057).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of a dual axis sensor and a single axis sensor disposed in spaced relation relative to each other and configured to provide positional feedback indicative of one or more of a deflection or a rotation of the ultrasound probe in the invention of Schaer and Kong, as taught by Ziv-Ari, to be able to measure signal indictive to position and orientation of the shaft and distal end.
Regarding claim 37, Schaer, Kong and Ziv-Ari disclose the invention substantially as described in the 103 rejection above, furthermore, Ziv-Ari teaches wherein the dual axis sensor is disposed adjacent the ultrasound probe (see 52 in fig. 3B) and the single axis sensor is spaced proximally from the dual axis sensor along a longitudinal axis of the deflectable shaft (see 99 in fig. 3B). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the dual axis sensor is disposed adjacent the ultrasound probe and the single axis sensor is spaced proximally from the dual axis sensor along a longitudinal axis of the deflectable shaft in the invention of Schaer and Kong, as taught by Ziv-Ari, to be able to measure signa indictive to position and orientation of the shaft and distal end for two different dedicated sensors.
Claims 17-22 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Ziv-Ari et al. (US 2023/0218272; hereinafter Ziv-Ari), in view of Schaer et al. (WO 2021/108562; hereinafter Schaer), in view of Kong et al. (US 2013/0137955; hereinafter Kong).
Regarding claims 17 and 26, Ziv-Ari discloses controlling and visualizing rotation and deflection of a 4D ultrasound catheter. Ziv-Ari shows an ultrasound imaging tool (see par. [0012], fig. 3A-B) configured with rotation (see 60 in fig. 2; par. [0050]) and deflection control (see 66 in fig. 2; par. [0049]), the tool comprising: an ultrasound probe (see fig. 3A-B; par. [0054]) disposed adjacent a distal tip region of a rotatable shaft such that rotation of the rotatable shaft causes rotation of the distal tip region (see par. [0053 and fi. 3A) and the ultrasound probe (see fig. 3A); a deflectable shaft disposed relative to the rotatable shaft such that deflection of the deflectable shaft causes deflection of at least the distal tip region of the rotatable shaft to control a position of the distal tip region and ultrasound probe (see fig. 3B; par. [0047]); and a dual axis sensor (see par. [0017], [0018], [0055]) )and a single axis sensor (see par. [0057]) disposed in spaced relation relative to each other (see fig. 3B) and configured to provide positional feedback indicative of a deflection and a rotation of the ultrasound probe (see par. [0069]).
Furthermore, Ziv-Ari shows flexible circuit board (see par. [0054]) but fails to explicitly state the flexible circuit board disposed adjacent the ultrasound transducer and in electrical communication with the ultrasound transducer, the flexible circuit board having a plurality of electrical component pads disposed thereon, and wherein the flexible circuit board is configured in a folded arrangement upon itself, wherein the folded arrangement comprises at least four folds.
Schaer shows further comprising a flexible circuit board disposed adjacent the ultrasound transducer and in electrical communication with the ultrasound transducer (see fig. 4, 5 and 6A-B), the flexible circuit board having a plurality of electrical component pads disposed thereon, and wherein the flexible circuit board is configured in a folded arrangement upon itself (see par. [0063], [0064], [0120]; fig. 5, 6A-G, 13A).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of a flexible circuit board disposed adjacent the ultrasound transducer and in electrical communication with the ultrasound transducer, the flexible circuit board having a plurality of electrical component pads disposed thereon, and wherein the flexible circuit board is configured in a folded arrangement upon itself in the invention of Ziv-Ari, as taught by Schaer, to be able to provide power to the ultrasound transducer and transmit echo signal to the processor to process the signal to generate image, and provide space efficiency with foldable PCB.
But, Ziv-Ari and Schaer fail to explicitly state wherein the folded arrangement of the flexible circuit board comprises at least four folds.
Kong teaches flexible circuit board with folded arranged with at least four Folds and M-fold configuration (see 8A and 14C). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized the teaching of flexible circuit board with folded arranged with at least four Folds and M-fold configuration in the invention of Ziv-Ari Schaer and Schaer, as taught by Kong, to provide improved reliability and PCB with reduced space and weight.
Regarding claim 18, Ziv-Ari shows wherein the dual axis sensor is disposed adjacent the ultrasound probe (see 52 in fig. 3B) and the single axis sensor is spaced proximally from the dual axis sensor along a longitudinal axis of the deflectable shaft (see 99 in fig. 3B).
Regarding claim 19, Ziv-Ari shows wherein the dual axis sensor is disposed within or adjacent the distal tip region (see 52 in fig. 3B) and the single axis sensor is spaced proximally from the dual axis sensor along a longitudinal axis of the deflectable shaft (see 99 in fig. 3B).
Regarding claim 20, Ziv-Ari shows further comprising a handle assembly comprising a handle body with an outer surface that can be gripped by a user (see 32 in fig. 2; par. [0033]), a first actuator configured to be moved relative to the handle body (see 60 in fig. 2; par. [0050]), and a second actuator configured to be moved relative to the handle body (see 66 in fig. 2; par. [0049]), wherein the first actuator and the second actuator are circumferentially disposed about a longitudinal axis of the handle body (see fig. 2), wherein the rotatable shaft is in operable communication with the first actuator of the handle assembly such that actuation of the first actuator causes rotational movement of at least a portion of the rotatable shaft relative to the deflectable shaft (see par. [0050]), and wherein the deflectable shaft is in operable communication with the second actuator such that rotation of the second actuator causes deflection of the deflectable shaft and thereby deflection of the rotatable shaft (see par. [0049]).
Regarding claim 21, Ziv-Ari discloses the invention substantially as described in the 103 rejection above, but fails to explicitly state comprising a plurality of pull wires in communication with at least the second actuator and disposed along a longitudinal length of the deflectable shaft, the plurality of pull wires configured to one or more of converge or separate relative to each other to provide control over the deflection of the deflectable shaft.
Schaer discloses a cable routing and assemblies for medical device handles. Schaer teaches a plurality of pull wires in communication with at least the second actuator and disposed along a longitudinal length of the deflectable shaft (see par. [0048], [0054]; fig. 1B, 3Bii and 3Cii), the plurality of pull wires configured to one or more of converge or separate relative to each other to provide control over the deflection of the deflectable shaft (see par. [0048], [0054]; fig. 1B, 3Bii and 3Cii).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of a plurality of pull wires in communication with at least the second actuator and disposed along a longitudinal length of the deflectable shaft, the plurality of pull wires configured to one or more of converge or separate relative to each other to provide control over the deflection of the deflectable shaft in the invention of Ziv-Ari, as taught by Schaer, to be able to provide tension with the plurality of pull wires to accurately rotate and deflect the distal end of the medical device.
Regarding claim 22, Ziv-Ari and Schaer disclose the invention substantially as described in the 103 rejection above, furthermore, Schaer teaches wherein the ultrasound probe comprises an ultrasound transducer at least partially enclosed by a material to define a distal tip of an ultrasound imaging tool (see fig. 9B, 13A; par. [0112]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the ultrasound probe comprises an ultrasound transducer at least partially enclosed by a material to define a distal tip of an ultrasound imaging tool in the invention of Ziv-Ari, as taught by Schaer, to be able to protect the ultrasound transducer from surrounding tissue and fluid inside of a patient.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Schaer et al. (WO 2021/108562; hereinafter Schaer), in view of Kong et al. (US 2013/0137955; hereinafter Kong).
Regarding claim 43, Schaer discloses a cable routing and assemblies for medical device handles. Schaer shows an ultrasound imaging tool (see par. [0006]) configured with rotation (see 1003 in fig. 1A; par. [0048]) and deflection control (see 1001 in fig. 1A; par. [0048]), the tool comprising: an ultrasound probe disposed adjacent a distal tip region of a rotatable shaft such that rotation of the rotatable shaft causes rotation of the distal tip region and the ultrasound probe (see par. [0048], [0051], [0062] fig. 5), wherein the ultrasound probe comprises an ultrasound transducer at least partially enclosed by a material to define a distal tip of the ultrasound probe (see fig. 9B, 13A; par. [0112]); a deflectable shaft disposed relative to the rotatable shaft such that deflection of the deflectable shaft causes deflection of at least the distal region of the rotatable shaft to control a position of the distal tip region and ultrasound probe (see fig. 1A and par. [0048]); and a flexible circuit board disposed adjacent the ultrasound transducer and in electrical communication with the ultrasound transducer (see par. [0063], [00064]; fig. 5, 6A-G, 13A), the flexible circuit board having a plurality of electrical component pads disposed thereon (see par. [0063], [00064]; fig. 5, 6A-G, 13A), and wherein the flexible circuit board is configured in a folded arrangement upon itself (see par. [0063], [0064], [0120], ; fig. 5, 6A-G, 13A), wherein the flexible circuit board is interposed between the ultrasound transducer and a distal end of the deflectable shaft (see fig. 9B and 13A).
But, Schaer fails to explicitly state the folded arrangement of the flexible circuit board comprises at least four folds
Kong teaches flexible circuit board with folded arranged with at least four Folds (see 8A and 14C). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have utilized the teaching of flexible circuit board with folded arranged with at least four Folds in the invention of Schaer, as taught by Kong, to provide improved reliability and PCB with reduced space and weight.
Response to Arguments
The previous rejection under 35 USC 112 (b) to claims 1-43 has been withdrawn in view of Applicant’s amendments to claims 1, 17, 20, 21, 27 and 43.
Applicant's arguments filed 05/28/2026, with respect to prior art rejection, have been fully considered but they are not persuasive.
In response to Applicant’s arguments on pages 11-14, with respect to prior art Kong, the examiner respectfully disagrees. The examiner maintains that prior art Schaer does show a flexible circuit board disposed adjacent the ultrasound transducer and in electrical communication with the ultrasound transducer (see par. [0063], [00064]; fig. 5, 6A-G, 13A), the flexible circuit board having a plurality of electrical component pads disposed thereon (see par. [0063], [00064]; fig. 5, 6A-G, 13A), and wherein the flexible circuit board is configured in a folded arrangement upon itself (see par. [0063], [0064], [0120], ; fig. 5, 6A-G, 13A).
The examiner has relied on prior art Kong to teach flexible circuit board with folded arranged with at least four Folds and M-fold configuration (8A and 14C shows that the flexible circuit board with folded arrangement with at least four folds).
The Applicant argues that prior art Kong does not teach or suggest flexible circuit board disposed adjacent an ultrasound transducer and in electrical communication with the ultrasound transducer at the distal tip of an ultrasound imaging tool, however, the examiner did not rely on prior art Kong to teaches flexible circuit for an ultrasound imaging tool. The examiner has relied prior art Schaer to show a flexible circuit board for ultrasound imaging tool and is disposed adjacent the ultrasound transducer and in electrical communication with the ultrasound transducer (see par. [0063], [00064]; fig. 5, 6A-G, 13A), the flexible circuit board having a plurality of electrical component pads disposed thereon (see par. [0063], [00064]; fig. 5, 6A-G, 13A), and wherein the flexible circuit board is configured in a folded arrangement upon itself (see par. [0063], [0064], [0120], ; fig. 5, 6A-G, 13A). The examiner has relied on prior art Kong to merely teach a flexible circuit can have four folds (see fig. 8A and 14C).
The Applicant further argues that Kong is non-analogous art because its not same field of endeavor and is directed an implantable electrode lead system and associated electronics. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both the references (Schaer and Kong) are directed to medical devices, and both devices uses flexible circuits in medical devices. The examiner has relied on prior art Kong to teach that a flexible circuit can have four folds and did not rely on Kong to purpose of the implantable electrode.
The Applicant further argues that the present application addresses the problem of how to package flexible circuitry at the distal tip of an ultrasound probe, adjacent an ultrasound transducer and withing a rotatable/deflectable shaft assembly while maintain tight spatial constraints, shaft mechanics and ultrasound probe functionality, and Kong does not address this problem, the examiner respectfully disagrees. The examiner notes that a motivation to combine two references does not have to be provided by the references or does not have to solve the same problem presented by the specification of the current Application. The examiner notes that one of ordinary skill in the art would found it obvious to have utilized the teaching of flexible circuit board with folded arranged with at least four Folds and M-fold configuration in the invention of Schaer, as taught by Kong, to provide improved reliability and PCB with reduced space and weight.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rothberg et al. (US 2018/0070917) discloses folded circuit (see fig. 7 and par. [0042])
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 SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571)270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797
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