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 .
Response to Amendment
This office action is in response to the amendments filed November 12, 2025. Claims 1 and 5-16 are amended. Claims 2-4 are cancelled. Claims 1 and 5-16 are pending and addressed below.
Response to Arguments
Examiner withdraws the objection to the abstract of the application as it is indeed within 150 words. The specification objection is withdrawn.
Applicant’s arguments with respect to claim 1 have been fully considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s arguments are only directed to the claim amendments, which add new limitations to the claims and are addressed below.
Applicant’s arguments with respect to claim 4 have been fully considered but are not persuasive. Applicant argues that the “button map” of Clark provides feedback only when the input controls are actively being manipulated and that the one of ordinary skill would not find it obvious to modify as the button map does not pertain to a linkage between input control and a particular interventional device (page 7, “Claim rejections under 35 USC 102 and 103”). However, examiner notes that the input system of Clark disclosed in [0165] is further disclosing elements of input system 28, where Clark discloses several GUIs of input system 28. "GUI 400 is a configuration of a catheter-based procedure system with 10 three device modules" ([0164]). See also Figs. 20-21 regarding the GUI 400, where markers 404, 416 can be shown on a first side of the central longitudinal axis. As the disclosed matter of the GUI of [0165] is of the same input system 28 as the matter regarding the GUI of [0164], examiner maintains that the rejection under 35 USC 103 is properly motivated by Clark.
In light of the amendments to the claims, claim 1 has been issued a new rejection under 35 USC 112(b). See the relevant section below.
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 and 5-16 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, claim 1 claims “wherein the representations of the first interventional device and the second interventional device extend along a central longitudinal axis; wherein a first interventional device marker of the plurality of interventional device markers is positioned adjacent the first interventional device representation and on the first side of the central longitudinal axis when the first interventional device is linked to the first control, and wherein a second interventional device marker of the plurality of interventional device markers is positioned adjacent the second interventional device representation on the second side of the central longitudinal axis when the second interventional device is linked to the second control;”. However, there has been no established antecedent basis regarding “the first side of the central longitudinal axis” and “second side of the central longitudinal axis”. Examiner notes that any mention of a first and second side was in regards to the controller of the interventional device. As the indefinite matter is the first introduction to the sides of the central longitudinal axis of the interventional device, examiner suggests replacing the language to read “on a first side of the central longitudinal axis” and “on a second side of the central longitudinal axis. For prior art examination, examiner will interpret the claim with the above suggestions.
Dependent claims 5-16 are rejected under 35 USC 112(b) as they are dependent to independent claim 1 and given the same reasons for rejection.
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 1, 5, 8-9, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over US20220211452A1 (Clark) from the IDS.
Regarding claim 1, Clark discloses a robotic interventional control system comprising:
a first interventional device;
a second interventional device;
See Figs. 1 and 2. From Fig. 1, Clark describes a catheter-based procedure system 10 with a robotic drive 24 (Clark, [0073]). Fig. 2 shows that the robotic drive 24 may be equipped with several interventional devices and accessories 48 (Clark, [0074]).
a controller in communication with the first interventional device and the second interventional device, the controller comprising:
a first side and a second side;
a first control positioned on the first side of the controller; and
a second control positioned on the second side of the controller;
[0040] of Clark, “The first control and the second control may be positioned on the body so that the first control and the second control can be simultaneously manipulated by a first digit and a second digit on a hand of the user.”, where first digit and second digit are manipulating a first and second control positioned on a first side and a second side respectively.
one or more hardware processors in communication with the interventional device and the controller, the one or more hardware processors being configured to:
link the first interventional device to the first control and link the second interventional device to the second control such that movement of the first control causes a corresponding responsive movement of the first interventional device and movement of the second control causes a corresponding responsive movement of the second interventional device;
Clark discloses linking the first interventional device to the first control and linking the second interventional device to the second control (Clark, [0120-0121]) such that movement of the first control causes a corresponding responsive movement of the first interventional device and movement of the second control causes a corresponding responsive movement of the second interventional device (Clark, [0129-0130]).
generate a user interface, the user interface comprising an instrument window comprising,
[0160] of Clark, “In some embodiments, the control station 26 can include a user interface configured to provide a user with feedback and information regarding the state of the catheter-based procedure system 10.”,
a representation of the first interventional device;
a representation of the second interventional device; and
[0160] of Clark, “For example, the display 30 can provide a graphical user interface (GUI) that illustrates the positions and travel limits of the device modules 32 of a robotic drive 24. FIGS. 20 and 21 illustrate embodiments of a GUI 400 configure to provide position information for a robotic drive 24 with three device modules 32, which are denoted with the labels “C1,” “C2,” and “C3.” The three devices modules 32 are each represented by an icon 404, 406, 408 that is arranged linearly within a boundary region 412 that represents the total length of the robotic drive 24.”
a plurality of interventional device markers positioned relative to the representations of the first interventional device and the second interventional device, wherein the position of the plurality of interventional device markers relative to the representation of the first interventional device and the second interventional device indicates whether the first interventional device and the second interventional device are linked to the first control or the second control; and
See Figs. 20-21 and [0160] of Clark. From [0160], Clark discloses, “FIGS. 20 and 21 illustrate embodiments of a GUI 400 configure to provide position information for a robotic drive 24 with three device modules 32, which are denoted with the labels “C1,” “C2,” and “C3.” The three devices’ modules 32 are each represented by an icon 404, 406, 408 that is arranged linearly within a boundary region 412 that represents the total length of the robotic drive 24. To help the user to determine which icon 404, 406, 408 corresponds to each of the device modules 32, each of the icons can include a text label 416 that denotes which devices module 32 the icon 404, 406, 408 represents.”
wherein the representations of the first interventional device and the second interventional device extend along a central longitudinal axis;
See Figs. 20 and 21 of Clark, where the representations of the first interventional device and the second interventional device (Figs. 20-21, icons 404, 406, 408) extend along a central longitudinal axis (Fig. 21 represents an extended representation of Fig. 20). The GUI 400 contains the interventional devices capable of extending along an axis by use of “independent stage translation motors 64 a-d” (Clark, [0087]), where Figs. 20 and 21 show an example of the actuation. Said axis is defined by Clark as “the line or axis along the length of the member that passes through the center of the transverse cross section of the member in the direction from a proximal portion of the member to a distal portion of the member. For example, the longitudinal axis of a guidewire is the central axis in the direction from a proximal portion of the guidewire toward a distal portion of the guidewire even though the guidewire may be non-linear in the relevant portion.” (Clark, [0016]).
wherein a first interventional device marker of the plurality of interventional device markers is positioned adjacent the first interventional device representation and on the first side of the central longitudinal axis when the first interventional device is linked to the first control, and
While Clark does not explicitly disclose the use of interventional device markers configured to be positioned on a first side of the central longitudinal axis, [0165] of Clark discloses, “In some embodiments, a GUI may also provide a graphical representation of the input system 28 and the input controls on input system (for example, the buttons, knobs, joysticks, or any other input controls) using an input map (not illustrated). As the input controls are manipulated by the user, the button map can indicate which input controls are being activated. This may be useful so that the user may see which input controls are being manipulated without looking at the input system 28. For example, the button map can include an array of icons corresponding to each or the input controls, which may be arranged on screen in a pattern that is similar to the physical arrangement of the input controls on the input system 28. Each icon can be configured to light up and/or be animated when manipulated by the user. For binary input controls, corresponding icon on the button may indicate whether the input control is in an activated (pressed) or inactivate (unpressed) state. The icons corresponding to analog input controls may indicate a degree of manipulation.”
One of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, that the system disclosed can be configured to change the icons to include additional function such as linking the first control to the first side of the central longitudinal axis.
wherein a second interventional device marker of the plurality of interventional device markers is positioned adjacent the second interventional device representation on the second side of the central longitudinal axis when the second interventional device is linked to the second control; and
In view of the rationale of “wherein a first interventional device marker …” above, one of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, that the system disclosed can be configured to change the icons’ positions to a second side of the central longitudinal axis when linked to a second control as there are a finite number of sides to try (above and below the graphical representations).
a display configured to display the user interface.
[0160] of Clark, “For example, the display 30 can provide a graphical user interface (GUI) that illustrates the positions and travel limits of the device modules 32 of a robotic drive 24.”
Regarding claim 5, with all the limitations of claim 1, the system further comprises:
wherein the first side of the central longitudinal axis mirrors the first side of the controller, and wherein the second side of the central longitudinal axis mirrors the second side of the controller.
See the rationale of claim 1 regarding “wherein a first interventional device marker …”. Clark discloses that the button map can include an array of icons corresponding to each or the input controls, which may be arranged on screen in a pattern that is similar to the physical arrangement of the input controls on the input system 28.
One of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, that the system of Clark is configured to rearrange the icons representative of the control of the system in a fashion that mirrors the first and second sides of the controller and central longitudinal axis both.
Regarding claim 8, with all the limitations of claim 1, the system further comprises:
wherein at least one of the plurality of interventional device marker comprises a first animation state and a second animation state.
[0165] of Clark, “For example, the button map can include an array of icons corresponding to each or the input controls, which may be arranged on screen in a pattern that is similar to the physical arrangement of the input controls on the input system 28. Each icon can be configured to light up and/or be animated when manipulated by the user. For binary input controls, corresponding icon on the button may indicate whether the input control is in an activated (pressed) or inactivate (unpressed) state. The icons corresponding to analog input controls may indicate a degree of manipulation.” This citation shows that the icons are different animation states are selected based on activation or inactivation in this case.
Regarding claim 9, with all the limitations of claim 8, the system further comprises:
wherein at least one of the plurality of interventional device marker is configured to transition from the first animation state to the second animation state upon an occurrence of an interventional device event.
See the citation reference in claim 8. Clark discloses in the paragraph that the icons can be configured to change to a different animation state based on an input control.
Regarding claim 16, with all the limitations of claim 1, the system further comprises:
wherein the first control and the second control of the controller are configured to cause movement of the first interventional device and the second interventional device responsive to a user input.
Clark discloses the first control and the second control of the controller are configured to cause movement of the first interventional device and the second interventional device responsive to a user input (Clark, [0121]).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over US20220211452A1 (Clark) from the IDS in view of US11931901B2 (Murphy).
Regarding claim 6, with all the limitations of claim 1, the system further comprises:
wherein the instrument window is configured to display an indicator on a top portion of each of the plurality of interventional device markers, the indicator configured to extend outside the top portion of each of the plurality of interventional device markers when an axial movement of the first interventional device or the second interventional device in a distal direction is restricted.
Clark discloses that the interventional device markers are capable of displaying indicators with functions such as lighting and animations (see [0165] of Clark), but does not disclose the indicator capable of being configured to extend out the top portion of the interventional device marker.
From a similar field of endeavor, Murphy discloses a robotic medical system with collision proximity indicators. Specifically, from Figs. 31 and 32 of Murphy, a type of indicator is shown where L2 and R5 (from Fig. 31) is shown to be larger than the others “to indicate that the second robotic arm and the fifth robotic arm are approaching a collision or near collision” (Murphy, col. 38, lines 18-20), where the box extended out the top and bottom portion of the marker is an intermediary state also known as a “near collision state” (Murphy, col. 38, lines 10-12). This type of feedback is intended to restrict motion in a specific direction of motion as collisions during operation would be unfavorable to the system.
One of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, to combine the indicator system of Murphy to the system of Clark as any operator of Clark’s system would also require a system to indicate a potential collision to avoid harmful motions towards the distal direction of the robotic interventional device.
Regarding claim 7, with all the limitations of claim 1, the system further comprises:
wherein the instrument window is configured to display an indicator on a bottom portion of at least one of the plurality of interventional device markers, the indicator configured to extend outside the bottom portion of the at least one of the plurality of interventional device markers when an axial movement of the interventional device associated with at least one of the plurality of interventional device markers in a proximal direction is restricted.
See rationale to claim 6 above. As the combination described from above would be to reduce possible collisions during the operation of the system, one of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, that said combination would also respond to a motion in proximal direction if there were a possible collision to occur in that way, indicating such by the expansion of the marker described from claim 6.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over US20220211452A1 (Clark) from the IDS in view of US20230380915A1 (Hundertmark).
Regarding claim 10, with all the limitations of claim 9, the system further comprises:
wherein the interventional device event comprises aspiration being available at the interventional device corresponding to the at least one of the plurality of interventional device markers.
While Clark discloses the system is capable of performing aspiration (Clark, [0035], “For treating arteriovenous malformations, a liquid embolic is injected into the malformation via a microcatheter. Mechanical thrombectomy to treat vessel occlusions can be achieved either through aspiration and/or use of a stent retriever. Depending on the location of the clot, aspiration is either done through an aspiration catheter, or through a microcatheter for smaller arteries. Once the aspiration catheter is at the lesion, negative pressure is applied to remove the clot through the catheter.”) and sending feedback signals such as warning signals and error codes ([0075]), Clark does not explicitly disclose the availability of aspiration as an interventional device event.
From a similar field of endeavor, Hundertmark discloses a system of robotic catheter systems that includes a GUI. From [0153] of Hundertmark, “If flow through one or more of the catheters 200 is not detected and the vacuum pressure is above a threshold pressure, the aspiration pump can be turned on (manually by an operator making a selection at the GUI 720 or automatically by software running on the controller 710). The software running on the controller 710 can continue to monitor the system pressure until a desired vacuum pressure is reached. Once the desired vacuum pressure is reached and there is no flow between the catheter 200 and the vacuum chamber of the aspiration system 805, the system can open a valve between the catheter 200 and the vacuum chamber. Flow detected when the valve between the vacuum chamber and the catheter 200 is closed indicates a leak in the system and an error message can be displayed on the GUI 720.” Hundertmark discloses a system capable of identifying when proper conditions have been met to initiate aspiration and also a GUI capable of receiving error messages regarding issues of the system.
One of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, to combine the aspiration system of Hundertmark to the system of Clark as a GUI icon indicating problems with aspiration availability would allow for immediate action during operations to prevent further issues from occurring deeper into the process.
Regarding claim 11, with all the limitations of claim 9, the system further comprises:
wherein the interventional device event comprises aspiration being unavailable at the interventional device corresponding to the at least one of the plurality of interventional device markers.
See rationale of claim 10 above.
Regarding claim 12, with all the limitations of claim 9, the system further comprises:
wherein the interventional device event comprises aspiration being active at the interventional device corresponding to the at least one of the plurality of interventional device markers.
In light of the rationale of claim 10, one of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, that the combination of Clark in view of Hundertmark would also include the flow detection with an open catheter that would indicate active aspiration.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over US20220211452A1 (Clark) from the IDS in view of US20200375671A1 (Wenderow).
Regarding claim 13, with all the limitations of claim 9, the system further comprises:
wherein the interventional device event comprises contrast injection being available at the interventional device corresponding to the at least one of the plurality of interventional device markers.
While Clark discloses their systems with contrast media delivery capability as well (Clark, [0074]) and sending feedback signals such as warning signals and error codes ([0075]), Clark does not explicitly disclose a system of checking contrast injection availability as an interventional device event.
From a similar field of endeavor, Wenderow discloses a remote workstation in control of intervention devices where a GUI is used to represent operational status of the devices such as contrast injection. From [0055] of Wenderow, “In another embodiment, GUI module 56 is configured to display an icon showing the amount of contrast media that has been delivered to the patient during the procedure. In one embodiment, this icon may also indicate the maximum amount of contrast agent that can safely be delivered to the patient. This icon may also indicate the amount of contrast agent that still may be delivered to the patient during the procedure. In one embodiment, this icon may be a meter that has a bar that increases as the amount of contrast media delivered increases. In another embodiment, GUI module 56 is configured to display an icon showing the amount of radiation that has been delivered to a patient during a particular procedure. This icon may also show the maximum amount of radiation that may be delivered during the procedure and may also show the current amount of radiation delivered as a percentage of the total that may be delivered.”
One of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, to combine the contrast agent tracking GUI icon of Wenderow to the system of Clark as it would act as a direct improvement for any cases where users of the system of Clark would need to safely gauge how much contrast has been used to minimize harm of the procedure.
Regarding claim 14, with all the limitations of claim 9, the system further comprises:
wherein the interventional device event comprises contrast injection being unavailable at the interventional device corresponding to the at least one of the plurality of interventional device markers.
See rationale of claim 13.
Regarding claim 15, with all the limitations of claim 9, the system further comprises:
wherein the interventional device event comprises contrast injection being active at the interventional device corresponding to the at least one of the plurality of interventional device markers.
See rationale of claim 13. One of ordinary skill in the art would find it obvious, prior to the applicant’s effective filing date, that changes of the icon showing maximum or current amounts of contrast or radiation would indicate activity of the injection. Furthermore, one would find it further obvious that an interventional device event to show activity can be easily made in light of the measured activity depending on rate of change.
Conclusion
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 JAEWOOK JUNG whose telephone number is (571)272-5470. The examiner can normally be reached Monday - Friday, 9:00 AM - 5:00 PM..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wade Miles can be reached on (571) 270-7777. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.J./Examiner, Art Unit 3656
/WADE MILES/Supervisory Patent Examiner, Art Unit 3656