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 .
Response to Amendment
The amendment filed on 04/09/2026 has been entered. Claims 1, 5-6, 11, 15 and 18-19 have been amended. Claims 4, 7, 9-10, 12-14 and 16-17 have been cancelled. Claims 1-3, 5-6, 8, 11, 15 and 18-20 remain pending.
Response to Arguments
On Pages 5-8 of Remarks, regarding the amended Claim 1, Applicant argues that reference Clark does not disclose the feature of “the first visual indication … comprises a first point …”, or “the second visual indication … comprises a second point …, and wherein a first distance … provides a visual indication about a second distance …”. Further, with respect to reference Soper, Applicant argues that Soper “does not disclose the generation of visual representations of the distal ends of interventional devices … on a user interface based on data from a sensor system in which the distance between the points … correlate to the distance between the distal ends …”, but in contrast, only discloses “the ability of a user to mark up an external image (not generated representations) of interventional devices”. Examiner respectfully disagrees. First, Soper was cited in the previous office action (Claims 16 and 17) not for its disclosure of generating representations, but for the claimed features of the first point and the second point. Clark discloses visual representations of interventional devices, such as in its Figs. 20-21. Further, visual representation can be in the form like Figs. 20-21 of Clark, but surely can also be based on imaging of a device as in Soper. Second, what Clark fails to disclose and Soper discloses, as claimed in original Claims 16-17 and now amended Claim 1, are the first point, the second point, and the first distance visually indicating the second distance. For these claimed features, Soper provides a proper disclosure in its Fig. 6, or specifically the markers “A” and “X” and their distance d2.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 6, 11 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Clark et al (US 20220211452 A1; hereafter Clark), in view of Soper et al (US 20210100627 A1; hereafter Soper).
With regard to Claim 1, Clark discloses a robotic interventional device control system (Clark, Abstract; “A system for controlling a catheter-based procedure system that includes a robotic drive …”) comprising:
a first interventional device having a first distal end (Clark, Para 0163; “… in one embodiment the distal tip of EMDs can be displayed (not shown). This may be helpful to drive an EMD inside another EMD without use of fluoroscopy.” Here, the “an EMD” corresponds to the first interventional device of Application);
a second interventional device having a second distal end (Clark, Para 0163; “… in one embodiment the distal tip of EMDs can be displayed (not shown). This may be helpful to drive an EMD inside another EMD without use of fluoroscopy.” Here, the “another EMD” corresponds to the second interventional device of Application), wherein the first interventional device is configured to be concentrically nested within the second interventional device (Clark, Para 0163; “This may be helpful to drive an EMD inside another EMD without use of fluoroscopy.” In these disclosures, “EMD” represents elongated medical device, so to one of ordinary skill in the art, the recited “an EMD inside another EMD” is equivalent to “an EMD concentrically nested within another EMD”);
a sensor system configured to detect a first position of the first interventional device and a second position of the second interventional device (Clark discloses 2 options or sensor systems for positioning EMD. Option 1 is based on imaging, as disclosed in Para 0082; “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.” Option 2 is based on a robotic drive 24 (Fig. 3), where each cassette 66a-d of each device module 32a-d “interface with and support a proximal portion of an EMD” (Para 0088); as a result, positions of the EMDs can be determined and then displayed in GUI 400, as disclosed in Para 0163; “In addition to displaying the proximal end of EMDs (as shown in FIG. 20 and FIG. 21), in one embodiment the distal tip of EMDs can be displayed (not shown).” Sensors are used to identify which device module drives which EMD, as in Para 0128; “The identity of the device module holding the wire-based EMD may be detected with sensors in response to loading the EMD into the device module.”);
Fig. 21 of Clark
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one or more hardware processors (Clark, Para 0084; “control computing system 34 may be an embedded system, a dedicated circuit, a general-purpose system programmed with the functionality described herein, etc.”) configured to generate a user interface (Clark, Para 0160; “… 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”), the user interface comprising an instrument window (Clark, Para 0160; “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”. Fig. 21 is cited. The disclosed GUI 400 contains instruments only, so corresponds to “instrument window” of Application), the instrument window comprising,
a first representation of the first interventional device, said first representation of the first interventional device including a first visual indication of the first distal end of the first interventional device (Clark, Para 0163; “In addition to displaying the proximal end of EMDs (as shown in FIG. 20 and FIG. 21), in one embodiment the distal tip of EMDs can be displayed (not shown). This may be helpful to drive an EMD inside another EMD without use of fluoroscopy.” In GUI shown in Figs. 20 and 21, both the proximal end and the distal end of EMDs can be displayed, corresponding to “representation” of Application. In this disclosure, “an EMD” corresponds to the first interventional device of Application), wherein the first visual indication comprises a first shape corresponding to a shape of the first distal end of the first interventional device (Clark, Para 0163; “In addition to displaying the proximal end of EMDs (as shown in FIG. 20 and FIG. 21), in one embodiment the distal tip of EMDs can be displayed ...” In the cited Fig. 21, the EMD labeled with C2 can correspond to the first interventional device of Application, and its distal tip to be displayed would be the first visual indication); and
a second representation of the second interventional device, said second representation of the second interventional device including a second visual indication of the second distal end of the second interventional device (Clark, Para 0163; “In addition to displaying the proximal end of EMDs (as shown in FIG. 20 and FIG. 21), in one embodiment the distal tip of EMDs can be displayed (not shown). This may be helpful to drive an EMD inside another EMD without use of fluoroscopy.” In this disclosure, “another EMD” corresponds to the second interventional device of Application), wherein the second visual indication comprises a second shape corresponding to a shape of the second distal end of the second interventional device (In the cited Fig. 21, the EMD labeled with C1 can correspond to the second interventional device of Application, and its distal tip to be displayed would be the second visual indication).
Clark does not clearly and explicitly disclose:
wherein the first visual indication of the first distal end comprises a first point on a distal edge of the first shape;
wherein the second visual indication of the second distal end comprises a second point on a second distal edge of the second shape; and
wherein the second visual indication of the second distal end is positioned relative to the first visual indication of the first distal end of the first interventional device based on the detected first and second positions received from the sensor system, thereby a first distance between the first point and the second point provides a visual indication about a second distance between the first distal end of the first interventional device and the second distal end of the second interventional device.
Soper in the same field of endeavor discloses:
wherein the first visual indication of the first distal end comprises a first point on a distal edge of the first shape (Soper, Para 0068; “… a display system 110 displays a concurrent or real-time external image 602 … identify the distal end 410 of the catheter 408 (e.g., by using a marker “X”) and the ultrasound probe 406 (e.g., by using a marker “A”) in the external image 602.”. In this disclosure, the ultrasound probe 406 corresponds to the first interventional device of Application, and its tip point is identified as demonstrated in Fig. 6);
wherein the second visual indication of the second distal end comprises a second point on a second distal edge of the second shape (Soper, Para 0068; “… a display system 110 displays a concurrent or real-time external image 602 … identify the distal end 410 of the catheter 408 (e.g., by using a marker “X”) and the ultrasound probe 406 (e.g., by using a marker “A”) in the external image 602.”. In this disclosure, the catheter 410 corresponds to the second interventional device of Application, and its tip point is identified as demonstrated in Fig. 6); and
wherein the second visual indication of the second distal end is positioned relative to the first visual indication of the first distal end of the first interventional device based on the detected first and second positions received from the sensor system, thereby a first distance between the first point and the second point provides a visual indication about a second distance between the first distal end of the first interventional device and the second distal end of the second interventional device (Soper, Fig. 6 shows the relative position of the distal end of the two devices, and its disclosed distance d2 between the two points visually indicates how far the distal ends of the two devices are).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark, as suggested by Soper, in order to include a point in visual indication of the distal end of each of the two EMDs and indicate a distance between the two points. One of ordinary skill in the art would have been motivated to make the modification for the benefit of enabling accurate determination of distance from the distal end of the device to other devices and therefore providing efficient and safe guidance for moving interventional devices.
With regard to Claim 6, Clark and Soper disclose the robotic interventional device control system of Claim 1. Clark further discloses wherein the first shape and the second shape are different from each other (Clark, Para 0135; “The introducer sheath is manually inserted into the femoral artery, giving a passageway for all other interventional devices (EMDs) to access the vasculature. The guide catheter, diagnostic catheter and guidewire are coaxial and inserted into the introducer sheath.”. Of all the listed EMDs, at least guidewire has a different shape of distal end from the listed sheath or catheters).
With regard to Claim 11, Clark and Soper disclose the robotic interventional device control system of Claim 1. Clark further discloses wherein the first shape comprise a cylindrical shape projected to a two-dimensional plane (Clark, Fig. 21 shows such a projected shape inside the region of 422 for the EMD labeled with C2), but does not explicitly and clearly disclose the first shape comprising a cylindrical shape in three-dimension (3D).
Soper further discloses the first shape comprising a cylindrical shape in three-dimension (3D) (Soper, Para 0093; “The virtual visualization image 1250 provides a virtual image of a catheter 1206 and a tool 1212 extending from a distal end 1210 of the catheter 1206.” Fig. 12B (cited) show the disclosed real-time virtual visualization image 1250, including the tool 1212 with a cylindrical shape.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark and Soper, as further suggested by Soper, in order to use a cylindrical shape in its 3D in the representation of the first device. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved accuracy for advancing the device to target by visualizing and moving the device in 3D.
Fig. 12B of Soper
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With regard to Claim 18, Clark and Soper disclose the robotic interventional device control system of Claim 1, but do not explicitly and clearly disclose wherein the first distance comprises a scaled distance of the second distance.
Soper further discloses wherein the first distance (the distance between the two points in the image 602 (or image coordinate system)) comprises a scaled distance of the second distance (the real distance between the distal tips 406 and 410 in real world (or catheter coordinate system)) (Soper, Para 0069; “… known anatomical landmark dimensions in the image 602 (e.g., a distance d1 between successive ribs 604-1 and 604-2) may be used to determine the distance d2 between the positions of the distal end 410 of the catheter 408 and the ultrasound probe 406 in the image 602.” This disclosure suggests that known anatomical landmark dimensions can be used to determine the scaling factor between the image coordinate system and the catheter coordinate system). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark and Soper, as further suggested by Soper, in order to visually indicate the distance between distal end of two device using a scaled distance determined in an image. One of ordinary skill in the art would have been motivated to make the modification for the benefit of graphically presenting the procedure using an image with flexible size, which can fit in the GUI window and at the same time show the relative distance between the distal tips.
With regard to Claim 19, Clark and Soper disclose the robotic interventional device control system of Claim 1. Clark further discloses wherein the first distance and the second distance are the same (Clark, Para 0164; “GUI 400 may also include numeric readout of device module position, which could be in reference to its absolute position along the full range of the system”. With the disclosed system, absolute position of a device module and thus its supported EMD can be determined, and is displayed in GUI 400; therefore the distance shown in GUI 400 is same as true distance between two EMDs).
With regard to Claim 20, Clark and Soper disclose the robotic interventional device control system of Claim 1. Clark further discloses comprising a controller having one or more controls configured to cause movement of at least one of the first interventional device and the second interventional device responsive to a user input (Clark, Para 0077; “Control station 26 generally includes one or more input systems 28 configured to receive user inputs to operate various components or systems of catheter-based procedure system 10. … input systems 28 may be configured to cause bedside unit 20 to perform various tasks using percutaneous intervention devices (e.g., EMDs) interfaced with the robotic drive 24 (e.g., to advance, retract, or rotate a guidewire, advance, retract or rotate a catheter”).
Claims 2, 3, 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Clark and Soper, in view of Laby (US 20230098497 A1; hereafter Laby).
With regard to Claim 2, Clark and Soper disclose the robotic interventional device control system of Claim 1. Clark further discloses wherein the user interface (Clark, “the display 30”) further comprises:
a first window configured to display fluoroscopy imagery from a vasculature of a patient (Clark, Para 0080; “… display 30 may be configured to display image data (e.g., X-ray images, MRI images, CT images, ultrasound images, etc.) …. Lesion or treatment assessment data (e.g. IVUS, OCT, FFR …” The listed imaging modalities can image vasculature and/or provide image from inside of a vessel);
a second window configured to display one or more messages indicative of an operational status of the robotic interventional device control system (Clark, Para 0080; “… display 30 may be configured to display procedure specific information (e.g., procedural checklist, recommendations, duration of procedure, catheter or guidewire position, volume of medicine or contrast agent delivered, etc.)”); and
a third window comprising a live feed (Clark, Para 0082; “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 … 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.”).
Clark and Soper as discussed above do not clearly and explicitly disclose wherein the instrument window is positioned on a central portion of the user interface.
Laby in the same field of endeavor discloses wherein the instrument window is positioned on a central portion of the user interface (Laby, Fig. 21 shows a user interface where the instrument window is positioned on a central portion. In Fig. 21, 258’ is a 3D virtual catheter model, and 262’’ is one of the model’s 2D projection (Para 0201)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark and Soper, as suggested by Laby, in order to display the instrument window on central portion of user interface. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved accuracy in guiding and/or monitoring the movement of the interventional devices by displaying the devices in the center of the display.
Fig. 21 of Laby
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With regard to Claim 3, Clark, Soper and Laby disclose the robotic interventional device control system of Claim 2 as discussed above, but do not explicitly and clearly disclose wherein the first window, the second window, and the third window are positioned around the instrument window.
Laby further discloses wherein the first window, the second window, and the third window are positioned around the instrument window (Laby, Fig. 21 shows a user interface where the non-instrument windows are positioned around the instrument window). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark, Soper and Laby, as further suggested by Laby, in order to position the non-instrument windows around the instrument window. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved accuracy in guiding and/or monitoring the movement of the interventional devices by making the various types of supportive information conveniently displayed and thus accessible.
With regard to Claim 8, Clark and Soper disclose the robotic interventional device control system of Claim 1, but does not clearly and explicitly disclose wherein the first representation of the first interventional device and the second representation of the second interventional device extend along a central longitudinal axis.
Laby in the same field of endeavor discloses wherein the first representation of the first interventional device and the second representation of the second interventional device extend along a central longitudinal axis (Laby, Para 0191; “The tool has an axis 166, and may be supported by a flexible catheter or other support structure extending distally along the axis to the tool, as described above.” Fig. 18A shows representations of the devices include distal tips and extend along the axis 166). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark and Soper, as suggested by Laby, in order to display representations of two devices along a central longitudinal axis. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved visualization of axial and lateral movement of distal tips by using the axis as a reference.
With regard to Claim 15, Clark and Soper disclose the robotic interventional device control system of Claim 1, but does not clearly and explicitly disclose wherein the first shape comprises a beveled edge.
Laby in the same field of endeavor discloses wherein the first shape comprises a beveled edge (Laby, Fig. 16A show a representation of a catheter with distal end that comprises a beveled edge). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark and Soper, as suggested by Laby, in order to use beveled edge in the first visual indication of the first distal end. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved efficiency and reduced risk of vessel injury in advancing the interventional device through narrow and/or tortuous blood vessel by using distal end with beveled edge and including such feature in its representation.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Clark and Soper, in view of Tal et al (US 20160331944 A1; hereafter Tal).
With regard to Claim 5, Clark and Soper disclose the robotic interventional device control system of Claim 1, but does not clearly and explicitly disclose wherein the shape of the first distal end of the first interventional device comprises a beveled surface.
Tal in the same field of endeavor discloses wherein the shape of the first distal end of the first interventional device comprises a beveled surface (Tal, Para 0086; “Catheter distal end 102 may include or end with an optional beveled tip 115 …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clark and Soper, as suggested by Tal, in order to use a beveled surface at the distal end of the interventional device. One of ordinary skill in the art would have been motivated to make the modification for the benefit of increased efficiency in advancing the interventional device through narrowed or clotted blood vessels (Tal, Para 0086; “…for assisting in catheter delivery through narrowed, clotted and/or otherwise obstructed portions in the blood vessel.”).
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 LEI ZHANG whose telephone number is (571)272-7172. The examiner can normally be reached Monday-Friday 8am-5pm E.T..
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/L.Z./ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
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