DETAILED ACTION
Response to Amendment
This is a Final Office Action on the merits in response to communications on 2026/03/17. Claims 1 – 6 and 10 – 15 are amended. Claims 1 – 18 are pending and are addressed below.
Response to Arguments
Applicant’s amendments have not overcome 102 rejections. Applicant has changed the scope of the claim language. The amendments are further addressed in the body of the Final Rejection.
Claim Rejections - 35 USC § 102
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 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 – 5, 7 – 14, and 16 – 18 rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Canale, et. al. (US 20220233263 A1), hereinafter referred to as Canale.
Regarding Claim 1:
A robotic device control system, comprising:
a controller in communication with a plurality of hub adapters, each of the plurality of hub adapters associated with and in communication with one of a plurality of hubs across a sterile barrier separating the plurality of hub adapters from the plurality of hubs, each of the plurality of hubs coupled to one of a plurality of interventional devices, the controller comprising:
Canale discloses “The bedside unit 20 includes a robotic drive 24, a positioning system 22 and may include additional controls and displays 46. As mentioned above, the additional controls and displays may be located on a housing of the robotic drive 24. Interventional devices and accessories 48 (e.g., guidewires, catheters, etc.) interface to the bedside system 20. In an embodiment, interventional devices and accessories 48 may include specialized devices (e.g., IVUS catheter, OCT catheter, FFR wire, diagnostic catheter for contrast, etc.) which interface to their respective adjunct devices 54, namely, an IVUS system, an OCT system, and FFR system, etc.” (Canale, [0165]) and “In one embodiment the on-device adapter is a hub-drive mechanism such as a driven gear located on the hub of an EMD.” (Canale, [0154]).
Canale additionally discloses “For a parallel configuration, the arms align selected modules in a parallel configuration, allowing the proximal hubs to pass one another.” (Canale, [0214]), teaching the ability to control multiple hubs.
Canale additionally discloses “The term sterile interface refers to an interface or boundary between a sterile and non-sterile unit.” (Canale, [0153]), teaching the “communication with one of a plurality of hubs across a sterile barrier” disclosed by the applicant.
a joystick; and
Canale discloses “In one embodiment, input modules 28 may include one or more touch screens, joysticks, scroll wheels, and/or buttons... Each of the input modules 28 may include one or more buttons, scroll wheels, joysticks, touch screen, etc. that may be used to control the particular component or components to which the control is dedicated.” (Canale, [0160]).
a plurality of hub actuators, wherein actuation of each of the plurality of hub actuators causes the joystick to be linked with one or more of the plurality of hub adapters such that movement of the joystick causes a corresponding responsive movement of the one or more of the plurality of hub adapters, thereby causing a corresponding responsive movement of the associated hubs of the plurality of hubs across the sterile barrier.
Canale discloses “Hub driving or proximal driving refers to holding on to and manipulating an EMD from a proximal position (e.g., geared adapter on catheter hub)... A parallel configuration or layout uses serial actuators (or drives) to drive two or more EMDs into a common EMD hub.” (Canale, [0173]).
Canale additionally discloses “For a parallel configuration, the arms align selected modules in a parallel configuration, allowing the proximal hubs to pass one another.” (Canale, [0214]), teaching the ability to control multiple hubs.
Canale additionally discloses “The term sterile interface refers to an interface or boundary between a sterile and non-sterile unit.” (Canale, [0153]), teaching communication across a sterile boundary.
Regarding Claim 2:
The robotic device control system of Claim 1, wherein actuation of a first hub actuator of the plurality of hub actuators and a second hub actuator of the plurality of hub actuators at the same time causes the joystick to be linked with a first hub adapter associated with the first hub actuator and a second hub adapter associated with the second hub actuator such that movement of the joystick causes a corresponding responsive movement of the first hub adapter and the second hub adapter.
Canale discloses “the robotic drive may be reconfigured to provide various serial device configurations. In other embodiments, various apparatus and methods may be used to provide a robotic drive with both serial and parallel device configurations” (Canale, [0199]).
Canale additionally discloses “Device selection buttons allow the user or operator 11 to select which of the percutaneous intervention devices loaded into the robotic drive 24 are controlled by input modules 28.” (Canale, [0160]) and “input modules 28 may include one or more touch screens, joysticks, scroll wheels, and/or buttons” (Canale, [0160]) and “the robotic drive may be reconfigured to provide various serial device configurations. In other embodiments, various apparatus and methods may be used to provide a robotic drive with both serial and parallel device configurations… FIG. 51 is a top view of a cassette with a bypass channel and elongated medical devices in a serial configuration in accordance with an embodiment and FIG. 52 is a top view of a cassette with a bypass channel and elongated medical devices in a parallel configuration in accordance with an embodiment. Referring to FIGS. 51 and 52, a cassette 550 incudes a bypass channel 554 and a bypass channel connection point 564. The cassette 550 includes a first EMD 558 and a first support track 552. In FIG. 51, a second EMD 560 is shown that is supported by a second support track 556 that connects to a hub 562 so that the second EMD may enter the hub 562 and pass through the first EMD 558 in a serial configuration.” (Canale, [0199]).
Regarding Claim 3:
The robotic device control system of Claim 1, further comprising a velocity actuator, wherein actuation of the velocity actuator changes a range of axial velocities over which responsive movement of the one or more of the plurality of hub adapters linked to the joystick occurs in response to movement of the joystick.
Canale discloses “When in a speed control mode, a multiplier button acts to increase or decrease the speed at which the associated component is moved in response to a manipulation of input modules 28.” (Canale, [0160]).
Regarding Claim 4:
The robotic device control system of Claim 1, wherein the system further comprises a second joystick, wherein the second joystick is linked to at least one of the plurality of hub adapters such that movement of the second joystick causes a responsive movement in the at least one of the plurality of hub adapters linked to the second joystick.
Canale discloses “In an alternative embodiment, a separate rail or linear member may be used to support and translate each stage 62a-d and device module 32a-d. FIG. 4 is a perspective view of a portion of a robotic drive for a catheter procedure system in accordance with an embodiment. Robotic drive 25 includes a device module 32a coupled to a first rail or linear member 80 using a stage 62a, a device module 32b coupled to a second rail or linear member 82 using a stage 62b and a device module 32c coupled to a third rail or linear member 84 using a stage 62c.” (Canale, [0174]) and “first device module 768 has been moved along the first position offset slide 782 to a position over a first gap 788 between the first 762 and third 766 rails. The second device module 770 has been moved along the second position offset slide 786 to a position over a second gap 790 between the second 764 and third 766 rails. A device module may be moved along a position offset slide either manually or robotically.” (Canale, [0201]).
Regarding Claim 5:
The robotic device control system of Claim 4, further comprising at least one additional hub actuator, wherein actuation of the at least one additional hub actuator is configured to link the second joystick with a different one of the plurality of hub adapters such that movement of the second joystick causes a responsive movement in the different one of the plurality of hub adapters.
Canale discloses input modules 28 may include one or more touch screens, joysticks, scroll wheels, and/or buttons. In addition to input modules 28, the control station 26 may use additional user controls 44 (shown in FIG. 2) such as foot switches and microphones for voice commands, etc.” (Canale, [0160]) and “The remote 42 and local 38 control stations can be different and tailored based on their required functionalities. The additional user controls 44 may include, for example, one or more foot input controls. The foot input control may be configured to allow the user to select functions of the imaging system 14 such as turning on and off the X-ray and scrolling through different stored images. In another embodiment, a foot input device may be configured to allow the user to select which devices are mapped to scroll wheels included in input modules 28.” (Canale, [0166]).
Regarding Claim 7:
The robotic device control system of Claim 1, wherein the plurality of hubs comprises a guide catheter hub configured to couple to a guide catheter, an access catheter hub configured to couple to an access catheter, and a procedure catheter hub configured to couple to a procedure catheter.
Canale discloses “each device module 32a-d may receive different types of EMDs, including but limited to, a sheath (also referred to as a long sheath), a guide catheter, a balloon guide catheter, a guiding sheath, a diagnostic guidewire (also known as a angiographic guidewire), an intermediate catheter, a support catheter, a digital access catheter, an aspiration catheter, a microcatheter, a delivery catheter, a wire-based EMD (e.g., a guidewire, a microwire, a stent retriever, an embolization coil), etc.” (Canale, [0172]).
Regarding Claim 8:
The robotic device control system of Claim 7, wherein the plurality of hubs comprises a guidewire hub configured to couple to a guidewire.
Canale discloses “The term elongated medical device (EMD) refers to, but is not limited to, catheters (e.g. guide catheters, microcatheters, balloon/stent catheters), wire-based devices (guidewires, embolization coils, stent retrievers, etc.), and devices that have a combination of these. Wire-based EMD includes, but is not limited to, guidewires, microwires, a proximal pusher for embolization coils, stent retrievers, self-expanding stents, and flow divertors… In one embodiment the EMD is a catheter having a hub at a proximal end of the catheter and a flexible shaft extending from the hub toward the distal end of the catheter, wherein the shaft is more flexible than the hub. In one embodiment the catheter includes an intermediary portion that transitions between the hub and the shaft that has an intermediate flexibility that is less rigid than the hub and more rigid than the shaft. In one embodiment the intermediary portion is a strain relief.” (Canale, [0148]).
Regarding Claim 9:
The robotic device control system of Claim 1, wherein the controller is in communication with a control system having one or more hardware processors, the one or more hardware processors being configured to generate a user interface including information regarding the plurality of hubs or the plurality of interventional devices.
Canale discloses “Bedside unit 20 may also include controls and displays 46 (shown in FIG. 2). For example, controls and displays may be located on a housing of the robotic drive 24.” (Canale, [0156]) and “Imaging system 14 may also be configured to take one or more X-ray images (e.g., real time images) during a catheter-based medical procedure to assist the user or operator 11 of control station 26 to properly position a guidewire, guide catheter, microcatheter, stent retriever, coil, stent, balloon, etc. during the procedure. The image or images may be displayed on display 30. For example, images may be displayed on display 30 to allow the user or operator 11 to accurately move a guide catheter or guidewire into the proper position.” (Canale, [163]).
Regarding Claim 10:
A robotic device control system, comprising:
a controller in communication with a plurality of hub adapters, each of the plurality of hub adapters associated with and in communication with one of a plurality of interventional devices across a sterile barrier separating the plurality of hub adapters from the plurality of interventional devices, the controller comprising:
Canale discloses “The bedside unit 20 includes a robotic drive 24, a positioning system 22 and may include additional controls and displays 46. As mentioned above, the additional controls and displays may be located on a housing of the robotic drive 24. Interventional devices and accessories 48 (e.g., guidewires, catheters, etc.) interface to the bedside system 20. In an embodiment, interventional devices and accessories 48 may include specialized devices (e.g., IVUS catheter, OCT catheter, FFR wire, diagnostic catheter for contrast, etc.) which interface to their respective adjunct devices 54, namely, an IVUS system, an OCT system, and FFR system, etc.” (Canale, [0165]), “in various embodiments described further below, the robotic drive 24 or one/or more device modules 32a-d may be configured to provide one or more EMDs that are shaft driven. As mentioned above, in FIG. 3 the drive modules 32a-d are in a serial drive configuration (e., over-the-wire (OTW). A serial drive configuration or layout uses actuators (or drives) to drive an EMD into a more distal EMD hub.” (Canale, [0173]), and “In one embodiment the on-device adapter is a hub-drive mechanism such as a driven gear located on the hub of an EMD.” (Canale, [0154]).
Canale additionally discloses “For a parallel configuration, the arms align selected modules in a parallel configuration, allowing the proximal hubs to pass one another.” (Canale, [0214]), teaching the ability to control multiple hubs.
Canale additionally discloses “The term sterile interface refers to an interface or boundary between a sterile and non-sterile unit.” (Canale, [0153]), teaching communication across a sterile boundary.
a joystick; and
Canale discloses “In one embodiment, input modules 28 may include one or more touch screens, joysticks, scroll wheels, and/or buttons... Each of the input modules 28 may include one or more buttons, scroll wheels, joysticks, touch screen, etc. that may be used to control the particular component or components to which the control is dedicated.” (Canale, [0160]).
a plurality of interventional device actuators, wherein actuation of each of the plurality of interventional device actuators causes the joystick to be linked with one or more of the plurality of hub adapters such that movement of the joystick causes a corresponding responsive movement of the one or more of the plurality of hub adapters, thereby causing a corresponding responsive movement of the associated of interventional devices across the sterile barrier.
Canale discloses “Hub driving or proximal driving refers to holding on to and manipulating an EMD from a proximal position (e.g., geared adapter on catheter hub)... A parallel configuration or layout uses serial actuators (or drives) to drive two or more EMDs into a common EMD hub.” (Canale, [0173]).
Canale additionally discloses “For a parallel configuration, the arms align selected modules in a parallel configuration, allowing the proximal hubs to pass one another.” (Canale, [0214]), teaching the ability to control multiple hubs.
Canale additionally discloses “The term sterile interface refers to an interface or boundary between a sterile and non-sterile unit.” (Canale, [0153]), teaching communication across a sterile boundary.
Regarding Claim 11:
The robotic device control system of Claim 10, wherein actuation of a first interventional device actuator of the plurality of interventional device actuators and a second interventional device actuator of the plurality of interventional device actuators at the same time causes the joystick to be linked with a first hub adapter of the plurality of hub adapters associated with the first interventional device actuator and a second hub adapter of the plurality of hub adapters associated with the second interventional device actuator such that movement of the joystick causes a corresponding responsive movement of the first hub adapter and the second hub adapter.
Canale discloses “the robotic drive may be reconfigured to provide various serial device configurations. In other embodiments, various apparatus and methods may be used to provide a robotic drive with both serial and parallel device configurations” (Canale, [0199]).
Canale additionally discloses “Device selection buttons allow the user or operator 11 to select which of the percutaneous intervention devices loaded into the robotic drive 24 are controlled by input modules 28.” (Canale, [0160]) and “input modules 28 may include one or more touch screens, joysticks, scroll wheels, and/or buttons” (Canale, [0160]) and “the robotic drive may be reconfigured to provide various serial device configurations. In other embodiments, various apparatus and methods may be used to provide a robotic drive with both serial and parallel device configurations… FIG. 51 is a top view of a cassette with a bypass channel and elongated medical devices in a serial configuration in accordance with an embodiment and FIG. 52 is a top view of a cassette with a bypass channel and elongated medical devices in a parallel configuration in accordance with an embodiment. Referring to FIGS. 51 and 52, a cassette 550 incudes a bypass channel 554 and a bypass channel connection point 564. The cassette 550 includes a first EMD 558 and a first support track 552. In FIG. 51, a second EMD 560 is shown that is supported by a second support track 556 that connects to a hub 562 so that the second EMD may enter the hub 562 and pass through the first EMD 558 in a serial configuration.” (Canale, [0199]).
Regarding Claim 12:
The robotic device control system of Claim 10, further comprising a velocity actuator, wherein actuation of the velocity actuator changes a range of axial velocities over which responsive movement of the one or more of the plurality of hub adapters linked to the joystick occurs in response to movement of the joystick.
Canale discloses “When in a speed control mode, a multiplier button acts to increase or decrease the speed at which the associated component is moved in response to a manipulation of input modules 28.” (Canale, [0160]).
Regarding Claim 13:
The robotic device control system of Claim 10, wherein the system further comprises a second joystick, wherein the second joystick is linked to at least one of the plurality of hub adapters such that movement of the second joystick causes a responsive movement in the at least one of the plurality of hub adapters linked to the second joystick.
Canale dislocses “In an alternative embodiment, a separate rail or linear member may be used to support and translate each stage 62a-d and device module 32a-d. FIG. 4 is a perspective view of a portion of a robotic drive for a catheter procedure system in accordance with an embodiment. Robotic drive 25 includes a device module 32a coupled to a first rail or linear member 80 using a stage 62a, a device module 32b coupled to a second rail or linear member 82 using a stage 62b and a device module 32c coupled to a third rail or linear member 84 using a stage 62c.” (Canale, [0174]) and “first device module 768 has been moved along the first position offset slide 782 to a position over a first gap 788 between the first 762 and third 766 rails. The second device module 770 has been moved along the second position offset slide 786 to a position over a second gap 790 between the second 764 and third 766 rails. A device module may be moved along a position offset slide either manually or robotically.” (Canale, [0201]).
Regarding Claim 14:
The robotic device control system of Claim 13, further comprising at least one additional interventional device actuator, wherein actuation of the at least one additional interventional device actuator is configured to link the second joystick with a different one of the plurality of hub adapters such that movement of the second joystick causes a responsive movement in the different one of the plurality of hub adapters.
Canale discloses input modules 28 may include one or more touch screens, joysticks, scroll wheels, and/or buttons. In addition to input modules 28, the control station 26 may use additional user controls 44 (shown in FIG. 2) such as foot switches and microphones for voice commands, etc.” (Canale, [0160]) and “The remote 42 and local 38 control stations can be different and tailored based on their required functionalities. The additional user controls 44 may include, for example, one or more foot input controls. The foot input control may be configured to allow the user to select functions of the imaging system 14 such as turning on and off the X-ray and scrolling through different stored images. In another embodiment, a foot input device may be configured to allow the user to select which devices are mapped to scroll wheels included in input modules 28.” (Canale, [0166]).
Regarding Claim 16:
The robotic device control system of Claim 10, wherein the plurality of interventional devices comprises a guide catheter, an access catheter, and a procedure catheter.
Canale discloses “each device module 32a-d may receive different types of EMDs, including but limited to, a sheath (also referred to as a long sheath), a guide catheter, a balloon guide catheter, a guiding sheath, a diagnostic guidewire (also known as a angiographic guidewire), an intermediate catheter, a support catheter, a digital access catheter, an aspiration catheter, a microcatheter, a delivery catheter, a wire-based EMD (e.g., a guidewire, a microwire, a stent retriever, an embolization coil), etc.” (Canale, [0172]).
Regarding Claim 17:
The robotic device control system of Claim 16, wherein the plurality of interventional devices comprises a guidewire.
Canale discloses “The term elongated medical device (EMD) refers to, but is not limited to, catheters (e.g. guide catheters, microcatheters, balloon/stent catheters), wire-based devices (guidewires, embolization coils, stent retrievers, etc.), and devices that have a combination of these. Wire-based EMD includes, but is not limited to, guidewires, microwires, a proximal pusher for embolization coils, stent retrievers, self-expanding stents, and flow divertors… In one embodiment the EMD is a catheter having a hub at a proximal end of the catheter and a flexible shaft extending from the hub toward the distal end of the catheter, wherein the shaft is more flexible than the hub. In one embodiment the catheter includes an intermediary portion that transitions between the hub and the shaft that has an intermediate flexibility that is less rigid than the hub and more rigid than the shaft. In one embodiment the intermediary portion is a strain relief.” (Canale, [0148]).
Regarding Claim 18:
The robotic device control system of Claim 10, wherein the controller is in communication with a control system having one or more hardware processors, the one or more hardware processors being configured to generate a user interface including information regarding the plurality of interventional devices.
Canale discloses “Bedside unit 20 may also include controls and displays 46 (shown in FIG. 2). For example, controls and displays may be located on a housing of the robotic drive 24.” (Canale, [0156]) and “Imaging system 14 may also be configured to take one or more X-ray images (e.g., real time images) during a catheter-based medical procedure to assist the user or operator 11 of control station 26 to properly position a guidewire, guide catheter, microcatheter, stent retriever, coil, stent, balloon, etc. during the procedure. The image or images may be displayed on display 30. For example, images may be displayed on display 30 to allow the user or operator 11 to accurately move a guide catheter or guidewire into the proper position.” (Canale, [163]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6 and 15 are rejected under U.S.C. 103 as being unpatentable over Canale, et. al. (US 20220233263 A1), hereinafter referred to as Canale, in view of Belson (US 20020022765 A1), hereinafter referred to as Belson.
Regarding Claim 6:
The robotic device control system of Claim 1, wherein the joystick is configured to move along a first axis and a second axis different from the first axis, wherein movement of the joystick along the first axis is configured to cause a responsive axial movement of the hub adapters linked to the joystick, wherein movement of the joystick along the second axis is configured to cause rotational movement of at least some of the interventional devices coupled to the hubs.
Belson discloses “A steering control 122 is connected to the electronic motion controller 140 by way of a second cable 138. The steering control 122 allows the user to selectively steer or bend the selectively steerable distal portion 104 of the body 102 in the desired direction. The steering control 122 may be a joystick controller as shown, or other known steering control mechanism.” (Belson, [0022]).
Canale discloses a system to controlling the movement of hubs through the use of various input devices, including a joystick, however does not disclose specifically how the joystick would control individual axes. Belson however, does discloses a method of joystick control.
It would have been obvious to one having ordinary skill in the art at the time of the applicant’s effective filing date to combine the system of Canale with the joystick control method taught by Belson because there are only so many axes that a joystick can physically measure, and each of those axes need to be mapped to something. As disclosed in MPEP 2143, it would have been “obvious to try” the method disclosed by Belson within the system of Canale.
Regarding Claim 15:
The robotic device control system of Claim 10, wherein the joystick is configured to move along a first axis and a second axis different from the first axis, wherein movement of the joystick along the first axis is configured to cause a responsive axial movement of the hub adapters linked to the joystick, wherein movement of the joystick along the second axis is configured to cause rotational movement of at least some of the interventional devices.
Belson discloses “A steering control 122 is connected to the electronic motion controller 140 by way of a second cable 138. The steering control 122 allows the user to selectively steer or bend the selectively steerable distal portion 104 of the body 102 in the desired direction. The steering control 122 may be a joystick controller as shown, or other known steering control mechanism.” (Belson, [0022]).
Canale discloses a system to controlling the movement of hubs through the use of various input devices, including a joystick, however does not disclose specifically how the joystick would control individual axes. Belson however, does discloses a method of joystick control.
It would have been obvious to one having ordinary skill in the art at the time of the applicant’s effective filing date to combine the system of Canale with the joystick control method taught by Belson because there are only so many axes that a joystick can physically measure, and each of those axes need to be mapped to something. As disclosed in MPEP 2143, it would have been “obvious to try” the method disclosed by Belson within the system of Canale.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Peter Falb (US 20220125533 A1)
Falb teaches a method for controlling the “hub of a guide catheter”, however, does not teach a method for controlling a plurality of hubs, and was therefore not used as prior art.
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/J.B.C./
Examiner, Art Unit 3656
/WADE MILES/Supervisory Patent Examiner, Art Unit 3656
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