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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-43 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim limitation “a portion of the rotatable shaft” in line 13 is indefinite because it is unclear if this portion of the rotatable shaft is the same portion of the rotatable shaft that is recited in line 5.
Regarding claim 17, the claim limitation “the tip region” in line 4 is indefinite because it is unclear if the tip region is referring to the distal tip region that is recited in line 3 or a separate tip region.
Furthermore for claim 17, the claim limitation “the distal tip” in line 8 is indefinite because it is unclear if the distal tip is referring to the distal tip region that is already recited in line 3 or a separate distal tip.
Furthermore for claim 17, the claim limitation “a rotation of the ultrasound probe” in line 11 is indefinite because it is unclear if this rotation of the ultrasound probe is same as the rotation that is already recited in lines 4-5.
Regarding claim 20, the claim limitation “a portion of the rotatable shaft” in line 9 is indefinite because it is unclear if this portion of the rotatable shaft is the same portion of the rotatable shaft that is recited in claim 17.
Regarding claim 21, the claim limitation “the second actuator” lacks antecedent basis and further is indefinite because claim 17 does not recite any first actuator.
Regarding claim 27, the claim limitation “a portion of the rotatable shaft” in line 15 is indefinite because it is unclear if this portion of the rotatable shaft is the same portion of the rotatable shaft that is recited in line 5.
Regarding claim 43, the claim limitation “the tip region” in line 4 is indefinite because it is unclear if the tip region is referring to the distal tip region that is recited in line 3 or a separate tip region.
Claims 2-16, 18-19, 22-27 and 28-42 are rejected as they depend from rejected claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-9, 12-14, 27-35, and 38-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schaer et al. (WO 2021/108562; hereinafter Schaer).
Regarding claim 1, 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 a portion 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 a portion 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).
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 an ultrasound imaging tool (see fig. 9B, 13A; par. [0112]).
Regarding claim 13, Schaer shows further comprising 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).
Regarding claim 14, Schaer shows wherein the flexible circuit board is interposed between the ultrasound transducer and a distal end of the deflectable shaft (see fig. 9B and 13A).
Regarding claim 27, 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 a portion 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 a portion 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).
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 an ultrasound imaging tool (see fig. 9B, 13A; par. [0112]).
Regarding claim 39, Schaer shows further comprising 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).
Regarding claim 40, Schaer shows wherein the flexible circuit board is interposed between the ultrasound transducer and a distal end of the deflectable shaft (see fig. 9B and 13A).
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 17-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ziv-Ari et al. (US 2023/0218272; hereinafter Ziv-Ari).
Regarding claim 17, 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 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 a portion of the rotatable shaft to control a position of the distal tip 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]).
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]).
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 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 Ziv-Ari et al. (US 2023/0218272; hereinafter Ziv-Ari).
Regarding claim 10, Schaer discloses 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, 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 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, 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 discloses 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, 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 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, 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 15-16 and 41-42 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 15 and 16, Schaer discloses the invention substantially as described in the 102 rejection above, 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 claims 41-42, Schaer discloses the invention substantially as described in the 102 rejection above, 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.
Claims 21-24 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).
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.
Regarding claim 23, Ziv-Ari and Schaer disclose the invention substantially as described in the 103 rejection above, 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
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, 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.
Regarding claim 24, Ziv-Ari and Schaer disclose the invention substantially as described in the 103 rejection above, furthermore, Ziv-Ari wherein the flexible circuit board is interposed between the ultrasound transducer and the dual axis sensor (see par. [0054] and fig. 3A-B).
Claims 25-26 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) as applied to claim 23 above, and further in view of in view of Kong et al. (US 2013/0137955; hereinafter Kong).
Regarding claims 25-26, Ziv-Ari and Schaer disclose the invention substantially as described in the 102 rejection above, 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 Ziv-Ari Schaer, as taught by Kong, to provide improved reliability and PCB with reduced space and weight.
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 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 an ultrasound imaging tool (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 a portion of the rotatable shaft to control a position of the distal tip 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.
Conclusion
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.
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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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