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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 4-5, 9-10, 15, 27-28, 54-55, 58-59 are rejected under 35 U.S.C. 103 as being unpatentable over Bogusky (Pub. No.: US 2014/0148673) in view of Barbagli et al (Pub. No.: US 2020/0078096)
Regarding claim 1, Bogusky discloses a device comprising:
an elongated member (catheter 100 can be used as leader catheter 38) having a longitudinal axis, a proximal end and a distal end [see abstract, 0084, 0095, fig 7] by disclosing a catheter body 50 having a proximal end 52 and a distal end 54, as well as a proximal interface in the form of a leader catheter steering adapter 56 operably mounted to the proximal end 52 of the catheter body 50 [see 0084];
wherein the elongated member comprises at least one section at (distal articulating section 114), along or near the distal end, wherein the at least one section comprises at least one physical property (flexible) that is different than said physical property (stiffer) of sections (transition section 116) of the elongated member immediately adjacent the at least one section [see 0098-0099];
a displacing element (instrument driver 34 comprises a housing 64 that contains motors) configured to modify a length of the elongated member along the at least one section [see 0085] by disclosing instrument driver 34 comprises a housing 64 that contains motors. The respective adapters 48, 56 and the proximal end 60 of the guide wire body 58 are mechanically interfaced to the housing 64 in such a manner that they may be axially displaced relative to each other via operation of the motors, thereby effecting insertion or retraction movements of the respective guide sheath 36, leader catheter 38, and guide wire 40 relative to each other [see 0085];
at least one sensing element [see claim 6, 0024, 0123] by disclosing the electrode can be used as a conductive surface that either measures a localized electrical potential or delivers RF ablation energy [see 0123] and an electrode mounted to the distal working section of the catheter body [see claim 6];
wherein the distal end of the elongated member at least partially rotates around the longitudinal axis when the length of the elongated member along the at least one section is modified using the displacing element [see 0085, 0087];
a bending assembly ((proximal adapter that is a proximal steerable interface and/or control ring 106 or leader catheter steering adapter 56)) configured to bend the distal end of the elongated member relative to the longitudinal axis [see 0024, 0084-0085, 0088, 0097] by disclosing proximal adapter is a proximal steerable interface that is manipulatable to selectively tension the pullwire to bend the distal articulating section [see 0024] and a catheter body 50 having a proximal end 52 and a distal end 54, as well as a proximal interface in the form of a leader catheter steering adapter 56 operably mounted to the proximal end 52 of the catheter body 50 [see 0084];
wherein advancement of the device through a subject’s intraluminal network is facilitated by a rotational movement created by manipulation of the displacing element (instrument driver 34 comprises a housing 64 that contains motors) and a bending movement created by manipulation of the bending assembly [see 0085, 0087] by disclosing instrument driver 34 comprises a housing 64 that contains motors. The respective adapters 48, 56 and the proximal end 60 of the guide wire body 58 are mechanically interfaced to the housing 64 in such a manner that they may be axially displaced relative to each other via operation of the motors, thereby effecting insertion or retraction movements of the leader catheter 38, and guide wire 40 relative to each other [see 0085];
Bogusky doesn’t disclose and wherein the at least one sensing element is configured to enable the device to be used with an advancement system that is operated at least partially autonomously.
Nonetheless, Barbagli et al disclose at least one sensing element (position/location sensor system) [see 0026-0027, 0041-0044] and wherein the at least one sensing element is configured to enable the device to be used with an advancement system that is operated at least partially autonomously [see 0026, 0071] and/or a visualization system for capturing images from the distal end of the catheter system [see 0027] and position sensor data may be used to determine motion of the objects manipulated by the motors [see 0026]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Bogusky and Barbagli et al by using at least one sensing element and wherein the at least one sensing element is configured to enable the device to be used with an advancement system that is operated at least partially autonomously; for capturing images from the distal end of the catheter system [see 0027] and position sensor data may be used to determine motion of the objects manipulated by the motors [see 0026].
Regarding claims 4-5, Bogusky doesn’t disclose wherein the at least one sensing element sensor comprises at least one of the following: a pressure sensor, a contact sensor, a proximity sensor, a position sensor, a temperature sensor, a contact, a tracking sensor, a light sensor, a visualization sensor and an optical sensor and a marker, a camera, a visualization device, an imaging device
Nonetheless, Barbagli et al disclose wherein the at least one sensing element sensor comprises at least one of the following: a position sensor, a visualization sensor (camera) [see 0026-0027, 0041-0046] by disclosing the medical instrument 226 may be an image capture probe that includes a distal portion with a stereoscopic or monoscopic camera at or near the distal end 218 of the flexible body 216 for capturing images (including video images) [see 0046].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Bogusky and Barbagli et al by a visualization sensor; for capturing images from the distal end of the catheter system [see 0026] and position sensor data may be used to determine motion of the objects manipulated by the motors [see 0026].
Regarding claim 9, Bogusky discloses at least one therapy device, element or component [see claim 6, 0024, 0123] by disclosing the electrode can be used as a conductive surface that either measures a localized electrical potential or delivers RF ablation energy [see 0123] and an electrode mounted to the distal working section of the catheter body [see claim 6].
Regarding claim 10, Bogusky discloses wherein the at least one therapy device, element or component is positioned at, along or near the distal end of the elongated member [see claim 6, 0024, 0123] by disclosing the electrode can be used as a conductive surface that either measures a localized electrical potential or delivers RF ablation energy [see 0123] and an electrode mounted to the distal working section of the catheter body [see claim 6].
Regarding claim 15, Bogusky discloses wherein the device is configured to receive or otherwise accommodate at least one tool [see 0091, 0125].
Regarding claim 27, Bogusky discloses wherein the at least one physical property that is different comprises a tensile strength, a compressive strength, a rigidity [see 0098-0099], a stiffness [see 0098-0099], an elasticity, a thickness, a uniformity of thickness in a radial direction, a uniformity of thickness in an axial direction, a material or a material composition.
Regarding claim 28, Bogusky discloses wherein the at least one physical property that is different comprises a rigidity or a stiffness, wherein the rigidity or stiffness is less in the at least one section than in the sections of the elongated member immediately adjacent the at least one section [see 0098-0099]
Regarding claim 54, Bogusky discloses wherein the advancement system comprises at least one robotic component [see 0084] by disclosing a robotic instrument driver 34 [see 0084].
Regarding claim 55, Bogusky discloses comprising the at least one robotic component to manipulate at least one of the displacing element and the bending assembly (adapters) [see 0084].
Regarding claim 58, Bogusky discloses device comprising:
an elongated member (catheter 100 can be used as leader catheter 38) having a longitudinal axis, a proximal end and a distal end [see abstract, 0084, 0095, fig 7] by disclosing a catheter body 50 having a proximal end 52 and a distal end 54, as well as a proximal interface in the form of a leader catheter steering adapter 56 operably mounted to the proximal end 52 of the catheter body 50 [see 0084];
wherein the elongated member comprises at least one section at (distal articulating section 114), along or near the distal end, wherein the at least one section comprises at least one physical property (flexible) that is different than said physical property (stiffer) of sections (transition section 116) of the elongated member immediately adjacent the at least one section [see 0098-0099];
wherein a length (via tensioning or pulling the wires, emphasis added) of the elongated member along or near the at least one section is configured to be altered by a displacing element (instrument driver that houses a motor) [see 0024, 0084-0085, 0088, 0097];
at least one detection or therapy element or component (electrode) [see claim 6, 0123];
wherein the distal end of the elongated member at least partially rotates around the longitudinal axis when the length of the elongated member along the at least one section is modified using the displacing element ((instrument driver that houses a motor)) [see 0085, 0087];
wherein a distal end of the elongated member (leader catheter) is configured to be bent relative to the longitudinal axis using a bending assembly (proximal adapter that is a proximal steerable interface and/or control ring 106 or leader catheter steering adapter 56) [see 0024, 0084-0085, 0088, 0097] by disclosing proximal adapter is a proximal steerable interface that is manipulatable to selectively tension the pullwire to bend the distal articulating section [see 0024];
wherein advancement of the device through a subject’s intraluminal network is facilitated by a rotational movement created by manipulation of the displacing element and a bending movement created by manipulation of the bending assembly [see 0085, 0087] by disclosing instrument driver 34 comprises a housing 64 that contains motors. The respective adapters 48, 56 and the proximal end 60 of the guide wire body 58 are mechanically interfaced to the housing 64 in such a manner that they may be axially displaced relative to each other via operation of the motors, thereby effecting insertion or retraction movements of the leader catheter 38, and guide wire 40 relative to each other [see 0085];
Bogusky doesn’t disclose and wherein the at least one sensing element is configured to enable the device to be used with an advancement system that is operated at least partially autonomously.
Nonetheless, Barbagli et al disclose at least one sensing element (position/location sensor system) [see 0026-0027, 0041-0044] and wherein the at least one sensing element is configured to enable the device to be used with an advancement system that is operated at least partially autonomously [see 0026, 0071] and/or a visualization system for capturing images from the distal end of the catheter system [see 0027] and position sensor data may be used to determine motion of the objects manipulated by the motors [see 0026]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Bogusky and Barbagli et al by using at least one sensing element and wherein the at least one sensing element is configured to enable the device to be used with an advancement system that is operated at least partially autonomously; for capturing images from the distal end of the catheter system [see 0027] and position sensor data may be used to determine motion of the objects manipulated by the motors [see 0026].
Regarding claim 59, Bogusky discloses wherein the at least one detection or therapy element or component (electrode) is fixedly secured at or near the distal end of the elongated member [see claim 6, 0024, 0123] by disclosing the electrode can be used as a conductive surface that either measures a localized electrical potential or delivers RF ablation energy [see 0123] and an electrode mounted to the distal working section of the catheter body [see claim 6].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2, 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bogusky (Pub. No.: US 2014/0148673) in view of Barbagli et al (Pub. No.: US 2020/0078096) as applied to claim 1 above and further in view of Friedlander et al (Pub. No.: US 2019/0357751).
Regarding claims 2, 23, Bogusky discloses wherein: wherein the at least one sensing element unit (electrode) comprises at least one sensor [see claim 6, 0024, 0123] by disclosing the electrode can be used as a conductive surface that either measures a localized electrical potential or delivers RF ablation energy [see 0123] and an electrode mounted to the distal working section of the catheter body [see claim 6];
wherein the bending assembly ((proximal adapter that is a proximal steerable interface and/or control ring 106 or leader catheter steering adapter 56) is actuated using an electrically-controlled device [see 0084-0085] by disclosing instrument driver 34 comprises a housing 64 that contains motors. The respective adapters 48, 56 and the proximal end 60 of the guide wire body 58 are mechanically interfaced to the housing 64 in such a manner that they may be axially displaced relative to each other via operation of the motors, thereby effecting insertion or retraction movements of the leader catheter 38, and guide wire 40 relative to each other [see 0085].
Bogusky and Barbagli et al don’t disclose wherein the at least one section at, along or near the distal end comprises at least one partial cut comprising an orientation that is angled relative to both the longitudinal axis and an axis transverse to the longitudinal axis.
Nonetheless, Friedlander et al disclose wherein the at least one section at, along or near the distal end comprises at least one partial cut (cut-out or channel) comprising an orientation that is angled (as shown in figs 13, 15) relative to both the longitudinal axis and an axis transverse to the longitudinal axis [see figs 13, 15 and 0134-0136, 0145-0146, 0149] by disclosing a cut-out designed to house a device such as a sensor, imaging element [see 0135] and it may be desirable to use a camera capable of moving on multiple axes. For example, a camera capable of four-way deflection may be used [see 0149] which means the cut-out or channels that houses the camera comprising an orientation that is angled relative to both the longitudinal axis and an axis transverse to the longitudinal axis (emphasis added).
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Bogusky, Barbagli et al and Friedlander et al by having at least one section at, along or near the distal end comprises at least one partial cut comprising an orientation that is angled relative to both the longitudinal axis and an axis transverse to the longitudinal axis; to house a device such as a sensor, imaging element [see 0135, Friedlander et al].
Regarding claims 21-22, Bogusky and Barbagli et al don’t disclose at least one lumen or channel along the longitudinal axis of the at least one sensing element wherein said lumen or channel has at least one cut or similar feature along the longitudinal axis and wherein a diameter of the at least one lumen or channel along the longitudinal axis of the at least one sensing element can vary in response to passage or removal of one or more instruments, ancillary devices and/or similar features.
Nonetheless, Friedlander et al disclose at least one lumen or channel (conduit 112) along the longitudinal axis of the at least one sensing element wherein said lumen or channel has at least one cut (cut-out 132) or similar feature along the longitudinal axis [see 0134, figs 12-13] and wherein a diameter of the at least one lumen or channel along the longitudinal axis of the at least one sensing element can vary in response to passage or removal of one or more instruments, ancillary devices and/or similar features [see 0134, fig 13] by disclosing Cut-outs may conform a shape of devices, tubing, and/or other elements. In some instances, cut-outs may help to elements placed within a conduit. As shown in FIG. 13, an outer diameter and geometry is varied along the length of the distal element 110 [see 0134].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Bogusky, Barbagli et al and Friedlander et al by using at least one lumen or channel along the longitudinal axis of the at least one sensing element wherein said lumen or channel has at least one cut or similar feature along the longitudinal axis and a diameter of the at least one lumen or channel along the longitudinal axis of the at least one sensing element can vary in response to passage or removal of one or more instruments, ancillary devices and/or similar features; in order to a shape of devices, tubing, and/or other elements and cut-outs may help to elements placed within a conduit [see 0134, Friedlander et al].
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bogusky (Pub. No.: US 2014/0148673) in view of Barbagli et al (Pub. No.: US 2020/0078096) as applied to claim 1 above and further in view of Sonnenschein et al (Pub. No.: US 2005/0277808).
Regarding claim 8, Bogusky and Barbagli et al don’t disclose wherein the at least one sensing element unit is removably or releasably secured at or near the distal end of the elongated member.
Nonetheless, Sonnenschein et al disclose at least one sensing element unit (camera assembly) is removably or releasably secured at or near the distal end of the elongated member [see 0011, 0029, 0031, 0034] by disclosing removable camera 112, which is also installed within endcap 118 at catheter distal end 116 [see 0031].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Bogusky, Barbagli et al and Sonnenschein et al by using at least one sensing element unit (camera assembly) is removably or releasably secured at or near the distal end of the elongated member; can provide a cost-effective method of increasing a physician's daily throughput in relation to the number of endoscope inspection procedures performed [see 0009, Sonnenschein et al].
Claim(s) 32, 37, 40 are rejected under 35 U.S.C. 103 as being unpatentable over Bogusky (Pub. No.: US 2014/0148673) in view of Barbagli et al (Pub. No.: US 2020/0078096) as applied to claim 1 above and further in view of Chen et al (Pub. No.: US 2005/0143664).
Regarding claim 32, 37, 40, Bogusky and Barbagli et al don’t disclose wherein the displacing element comprises a pusher member or a force imparting member; wherein the displacing element is controlled by a separate device and wherein the separate device comprises a wireless component configured to wirelessly provide energy to or communicate with the displacing element during use.
Nonetheless, Chen et al disclose the displacing element comprises a pusher member or a force imparting member [see abstract, 011, 0015, 0023, claims 1, 23];
wherein the displacing element is controlled by a separate device [see 0023] by disclosing an actuator coupled to the motor for linearly displacing the motor [see 0023];
wherein the separate device comprises a wireless component configured to wirelessly provide energy to or communicate with the displacing element during use [see 0039] by disclosing wireless power delivery to motor 12 is possible since the power required for the MEMS motor 12 is extremely small [see 0039] and a motor disposed in a distal portion of the probe body to provide a motive force [see claim 1].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Bogusky, Barbagli et al and Chen et al by using a force imparting member; a separate device comprises a wireless component configured to wirelessly provide energy to the displacing element; to eliminates the need for physical cords and cables, making it more convenient for users; Since no physical connectors are involved, charging ports and cables have less wear and tear, extending the lifespan of devices; Designed with safety in mind, often including temperature monitoring and foreign object detection to prevent overheating or damage; Works through various materials, such as wood, plastic, and glass, allowing for more flexibility in device design.
Conclusion
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3798