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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/24/2026 has been entered.
Priority
Acknowledgement is made to Applicant’s claim to priority to U.S. Provisional App. No. 63/133,091 filed December 31, 2020.
Status of Claims
This Office Action is responsive to the claims filed on 01/30/2026. Claims 1, 4, 14, 15, and 18 have been amended. Claims 2, 13, and 17 have been cancelled. Claim 21 was previously cancelled. Claims 22 and 23 are newly presented. Claims 1, 3-12, 14-16, 18-20, 22, and 23 are presently pending in this application.
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, 3-9, 14-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Verard (US 20120059249) in view of Viswanathan (US 20160192995), Vertikov (US 20190142528 A1), and Hoeg (US 20060189842).
Regarding claim 1, Verard teaches a medical system (Paragraph [0015] and [0025]; A navigation system is provided including a catheter) comprising:
a display system (Paragraph [0059]; work station 34 having a display 36);
an elongate device (Paragraph [0149]; delivery tube 328, Figs. 21 and 23); and
a control system (Paragraph [0022]; Programs executed by the control system process the sensor data for determining the location of the location sensors relative to a reference source; embodied as a computer; Paragraph [0061]; computer or work station 34, Fig. 1) communicatively coupled to the display system (Paragraph [0059]; work station 34 having a display 36), the control system configured to:
display a graphical user interface via the display system (Paragraph [0090]; the navigation system 10 can also map on the display 36 the delivery of cell or drug therapy or other therapies that are annotated on 2D, 3D or 4D images or graphic displays; Paragraph [0111]-[0112]; display blocks 192, 198, 202, Fig. 11), the graphical user interface including a virtual navigation view (Paragraph [0027]; The display displays the virtual images; Paragraph [0063]; icon representing the location of a catheter or other instrument, introduced and advanced in the patient 14, may be superimposed in more than one view on display 36 allowing simulated bi-plane or even multi-plane views, including two and three-dimensional views; multi-plane views with the location of the catheter is considered to read on the claimed limitation of a virtual navigation view as understood in its broadest reasonable interpretation) and a fluoroscopic view (Paragraph [0059]; Two dimensional fluoroscopic images taken by the imaging device 12 are captured and stored in the C-arm controller 28; facilities for displaying on the display 36, the received images);
display an image of a representation of the elongate device in the virtual navigation view (Paragraph [0126]; the navigation catheter 52 is inserted into one of the patient's organs, such as the heart, via block 222 and its virtual representation is displayed on the images, via block 258.);
based on a position of an imaging probe (Paragraph [0072]; The catheter 52; Paragraph [0134] and [0141]-[0142]; an ultrasound imaging device or Doppler sensor in the catheter 52; intravascular ultrasound (IVUS) catheter 296, Fig. 18) configured to extend within the elongate device (Paragraph [0149]; The insert 334 is operable to be slidably inserted within passage 332 defined in handle 330 in order to pass into delivery tube 328, as illustrated in FIG. 23. The insert 334 enables the use of various conventional catheters, such as the catheter 326.), determine a position of an imaging probe marker in the virtual navigation view (Paragraph [0108]; The image 170 includes an icon 172 representing the location and position of the catheter 52, Fig. 9; Paragraph [0117]; the fluoroscopic image of the heart acquired with a real catheter is identified as reference numeral 228… it is possible to sync the superimposed or virtual representation of the instrument 232 with the image 228 to generate a good match; Fig. 14); and
based on a target location (paragraph [0097]; multiple landmarks or reference points are identified in the heart, a 3-D heart model or atlas heart model; Paragraph [0122]; a specific region in the anatomy, such as a vein), determine an orientation indicator for the imaging probe marker in the virtual navigation view (Paragraph [0108]; The icon 172 further includes a straight projection portion 174 that projects straight along the direction of the first sensor 58 within the catheter 52. This straight projection 174 represents a straight projected trajectory of the catheter 52, Fig. 9); and
based on the location of the orientation indicator, navigate the elongate device to the target location (Paragraph [0097]; the physician would know where the target is on the 3-D map or display 36 and can simply navigate the catheter 52 toward this target; Paragraph [0100]; micro-motion technology may also be used to precisely steer the catheter in an automated manner. In this regard, selective heating of a shaped memory metal enables and provides the ability to steer the catheter 52 or lead to a precise location).
Verard does not explicitly teach the imaging probe marker represents a field of view of the imaging probe, and wherein the imaging probe marker surrounds a representation of the imaging probe in the virtual navigation view;
based on an orientation of the imaging probe displayed in the fluoroscopic view, determining a plane of orientation of the imaging probe marker in the virtual navigation view;
determine a location of an orientation indicator for the imaging probe marker.
Viswanathan, however, teaches a medical system (Paragraph [0023]; a remote navigation system) comprising a control system (Paragraph [0031]; The remote navigation system has a high level control computer 110 that runs, among others, the remote navigation user interface) configured to
based on an orientation of the imaging probe displayed in the fluoroscopic view (Paragraph [0029]; the markers 123 serve to register the localization system with the remote navigation system via an X-ray system; Paragraph [0030]; information about the position and orientation of the distal tip of the sheath, and with the known data for the location and orientation of entry of the sheath base, the remote navigation system can compute the initial deflection plane of the sheath), determine a plane of orientation of the imaging probe marker in the virtual navigation view (Paragraph [0041]; A modeled sheath curve configuration 141 is shown extending from crossing plane 140 corresponding to the base of the sheath).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the control system of Verard to have further determined a plane of orientation of the imaging probe marker in the virtual navigation view based on an orientation of the imaging probe displayed in the fluoroscopic view as taught by Viswanathan because it would have allowed the remote navigation system runs a computational model to determine an optimal configuration of the deflectable sheath device and drives its placement such that the distal tip of the sheath is aimed approximately at the target while maintaining a pre-defined distance from the target by better tracking the plane in which the probe is located when entering an anatomical region (Viswanathan, Paragraph [0009], [0028]-[0029]).
Together Verard and Viswanathan do not explicitly teach the imaging probe marker represents a field of view of the imaging probe, and wherein the imaging probe marker surrounds a representation of the imaging probe in the virtual navigation view;
determine a location of an orientation indicator for the imaging probe marker.
Vertikov, however, teaches a medical system (Paragraph [0013]; , an image-guided system including an imaging probe, a guide sheath, and an imaging console is provided; Fig. 2A) comprising:
a display system (Paragraph [0121]; renderings can then be displayed to an operator (e.g., via the console 100), Fig. 2A);
an elongate device (Paragraph [0051]-[0053]; medical apparatus 150 can include a tool handling arrangement, or guide sheath, 250, an imaging probe 50; the guide sheath 250 can include an elongated flexible body or shaft 251D1 with a distal end 251 (shown in FIGS. 1A-1C));
a control system (Paragraph [0064]; the console 100);
displaying an image of a representation of the elongate device (Paragraph [0052]; , process the image data, and calculate a position of the medical tool 200 or the imaging probe 50 relative to a target in a patient body… This position information can then be used by the medical apparatus to render a “virtual” visualization of the tool or target; Fig. 23) in the virtual navigation view (Paragraph [0091]; The similarity comparison may also include a step (not shown) of creating a virtual endoscopic image from the intraoperative image data set; Fig. 8A, Fig. 21);
based on a position of an imaging probe configured to extend within the elongate device (Paragraph [0118]; the probe 50 can be repositioned using a steerable endoscope (not shown) that accommodates the probe distal end in a working channel of the endoscope. During repositioning, the probe distal end position is determined or tracked using any of the above-described position calculation methods), determine a position of an imaging probe marker in the virtual navigation view (Paragraph [0118]; Using this position tracking, all image data points in each FOV 55S14a1, 55S14a2, 55S14a3 associated with different locations of the probe distal end have determined coordinates), wherein the imaging probe marker represents a field of view of the imaging probe (Paragraph [0118]; cross-section of extended probe FOVs 55S14a1, 55S14a2, 55S14a3); wherein the imaging probe marker surrounds a representation of the imaging probe in the virtual navigation view (Paragraph [0118]; a distal end 5114a1 of a probe 50, Fig. 14A shows the FOV cross-sections surround the imaging probe as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Verard to include determine a position of an imaging probe marker in the virtual navigation view wherein the imaging probe marker represents a field of view of the imaging probe, wherein the imaging probe marker surrounds a representation of the imaging probe in the virtual navigation view as taught By Vertikov because it would have allowed determining the position of the FOVs with respect to the probe between repositioning of the probe which would further aid in the registration of the virtual image with the tissue reference frame, thereby allowing co-registering all the data points to one reference frame.
Together Verard, Viswanathan, and Vertikov do not explicitly teach determining a location of an orientation indicator for the imaging probe marker.
Hoeg, however, teaches a medical system (Paragraph [0020]; FIG. 3 shows a variable direction of view endoscopic system integrated with an image guided surgical system.) comprising a display system (Paragraph [0021]; display device 78, Fig. 4A);
an elongate device (Paragraph [0021]; endoscope 73, Fig. 4A);
an imaging probe (Paragraph [0018]; endoscope 10, Fig. 1);
a control system (Paragraph [0020]; central control unit 56, Fig. 3) communicatively coupled to the display system (Paragraph [0056]; An endoscopic video image 34 and additional relevant information are sent to a display device 30, Fig. 3), the control system configured to:
determine a position of an imaging probe marker (Paragraph [0021]; a representation of the endoscopic view cone 84 is also displayed; the view vector 76, Fig. 4A) in the virtual navigation view (Paragraph [0020]; the central control unit 56 can calculate and display a graphical representation) based on a position of the imaging probe (Paragraph [0020]; calculate and display the relative positions of the endoscope 10, the view vector 76, and the model 68.), wherein the imaging probe marker represents a field of view of the imaging probe (Paragraph [0021]; and graphical representations of the endoscope 73 and the view vector 76… , a representation of the endoscopic view cone 84 is also displayed; Fig. 4A);
determine a location of an orientation indicator (Paragraph [0021]; the view vector 76, Fig. 4A) for the imaging probe marker in the virtual navigation view based on a target location (Paragraph [0021]; the surgeon can target specific diagnostic locations on the model 68 with a joystick or other input device, and the endoscope will then automatically direct its view to these locations); and
navigate the elongate device to the target location (Paragraph [0025]; An endoscope 10 inserted into an anatomical cavity 50 searches for a landmark 120 automatically) based on the location of the orientation indicator (Paragraph [0022]; . The set of tip locations 108 available for a given target 106 will depend on the field of view of the endoscope, the mobility of its view vector, and the shape of the surgical cavity… The approach planner would also graphically display the viewable area associated with each entry tip location on the model 68, giving the user instant feedback as to what she can expect to be able to see from various view points).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Verard in view of Vertikov and Viswanathan to have further included the imaging probe marker further representing a field of view of the imaging probe; and determining a location of an orientation indicator for the imaging probe marker as taught by Hoeg because it would have aided the user's spatial understanding by including the representation of the endoscopic view cone and the orientation of the endoscopic image by a marker (Paragraph [0021]) and further allow automatically determining the imaging position and the region of interest (Paragraph [0025]).
Regarding claim 3, together Verard, Viswanathan, Vertikov, and Hoeg teach all of the limitations of claim 1 as noted above.
Verard further teaches the control system is further configured to display the orientation indicator in the virtual navigation view (Paragraph [0108]; The icon 172 further includes a straight projection portion 174 that projects straight along the direction of the first sensor 58 within the catheter 52. This straight projection 174 represents a straight projected trajectory of the catheter 52, Fig. 9).
Regarding claim 4, together Verard, Viswanathan, Vertikov, and Hoeg teach all of the limitations of claim 1 as noted above.
Verard further teaches the control system is further configured to adjust a position of the elongate device in the virtual navigation view based on a position of the representation of the elongate device displayed in the fluoroscopic view (Paragraph [0097]; 3-D heart model or atlas heart model is superimposed over the fluoroscopic images or modeled as a 3-D volume view by registering or translating the 3-D heart model in relation to the landmarks collected at block 148. This fusion occurs at block 150, which translates, rotates and scales the 3-D heart model, based upon the collected landmarks to provide a patient specific heart model).
Regarding claim 5, together Verard, Viswanathan, Vertikov, and Hoeg teach all of the limitations of claim 1 as noted above.
Verard further teaches the control system is further configured to adjust the orientation indicator from a default position to a suggested position based on the target location, wherein the target location is a preoperative target location (Paragraph [0122]-[0123]; virtual 3-dimensional curve can then be built to represent an actual cavity or vessel; Using known pattern recognition or distance map algorithms, it is then possible to locate and find the specific shape of that curve in the pre-operative scan or image and get an automatic path registration; which represents the final 3D shaped vessel, based on the curve 242, which represents the vein that is to be matched with a segment vein in the pre-operative or intraoperative scan, Fig. 13).
Regarding claim 6, together Verard, Viswanathan, Vertikov, and Hoeg teach all of the limitations of claim 1 as noted above.
Verard further teaches the control system is further configured to adjust the orientation indicator based on a preoperatively planned path (Paragraph [0115]; Still further, contours or paths within the navigated organ may also be used as fiducial markers for the registration process; image acquisition on this region of the patient is conducted. Again, the image acquisition can be from any type of imaging device and can be performed pre-operatively).
Regarding claim 7, together Verard, Viswanathan, Vertikov, and Hoeg teach all of the limitations of claim 1 as noted above.
Together Verard, Viswanathan, and Vertikov do not teach the field of view of the imaging probe marker represents an imaging plane of the imaging probe.
Hoeg, however, teaches the field of view of the imaging probe marker represents an imaging plane of the imaging probe (Paragraph [0025] the image data is matched with a stored electronic representation 122 of the landmark in question; the actual endoscopic images; Fig. 8A shows the imaging cone represents the plane of the image 120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Verard in view of Viswanathan, Vertikov, and Hoeg such that the field of view of the imaging probe marker represents an imaging plane of the imaging probe as taught by Hoeg because it would have allowed the surgeon to determine which parts of the surrounding anatomy is being imaged by the probe and would allow more effective localization in the surgical environment by collecting local visual information that can be correlated with preexisting data about the surroundings.
Regarding claim 8, together Verard, Viswanathan, Vertikov, and Hoeg teach all of the limitations of claim 1 as noted above.
Verard further teaches the imaging probe is an ultrasound probe and includes a transducer at a distal portion of the imaging probe (Paragraph [0141]; catheter that includes an ultrasound transducer 298; Fig. 18 shows the transducer is at a distal portion of the imaging probe).
Regarding claim 9, together Verard, Viswanathan, Vertikov, and Hoeg teach all of the limitations of claim 8 as noted above.
Verard teaches the longitudinal axis of the transducer is in the longitudinal axis of the catheter as shown in Fig. 18 but does not teach the imaging probe marker is perpendicular to a longitudinal axis of the transducer.
Viswanathan, however, further teaches the imaging probe marker is perpendicular to a longitudinal axis of the catheter (Paragraph [0018]; The user marks a length of catheter that extends from the sheath together with a crossing plane perpendicular to the sheath that marks an approximate entry location (into a heart chamber)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the imaging probe marker of Verard in view of Viswanathan, Vertikov, and Hoeg to be perpendicular to a longitudinal axis of the catheter and thus the perpendicular to a longitudinal axis of the transducer because it would have allowed indicating the entry position of a probe into a portion of the anatomy and thereby improve the ability to determine the probe position with respect to the anatomy (Paragraph [0018]).
Regarding claim 14, together Verard, Viswanathan, Vertikov, and Hoeg teach all of the limitations of claim 1 as noted above.
Verard discloses the invention as claimed and discussed above, but fails to explicitly disclose the representation of the imaging probe extends beyond a distal end of the image of the representation of the elongate device.
Viswanathan, however, further teaches the representation of the imaging probe extends beyond a distal end of the image of the representation of the elongate device (Paragraph [0018]; localized distal tip is graphically rendered in the X-ray view in the user interface... catheter that extends from the sheath; Paragraph [0040]; catheter has been positioned so that its distal tip portion 133 extends just beyond the sheath distal tip 132, Fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Verard in view of Viswanathan, Vertikov, and Hoeg such that the representation of the imaging probe extends beyond a distal end of the image of the representation of the elongate device because it would aid the user in determining where the catheter is positioned with respect to the sheath and thereby control the length of catheter extend from the sheath and thereby reduce the contact force exerted by the catheter tip (Paragraph [0039]).
Regarding claim 15, together Verard, Viswanathan, Vertikov and Hoeg teach all of the limitations of claim 1 as noted above.
Verard further teaches displaying the image of the representation of the elongate device includes displaying a temporary representation of the elongate device in the virtual navigation view (Paragraph [0099]; With a micro-motion catheter, further discussed herein, the catheter is positioned at each mapping site in a semi-autonomous fashion with user intervention as needed. For catheters without micro-motion, the system would highlight on the display 36, the next mapping point, along with the actual catheter position; The display of the catheter at each position is considered to read on the claimed limitation of temporary representations as understood in its broadest reasonable interpretation).
Regarding claim 16, together Verard, Viswanathan, Vertikov, and Hoeg teach all of the limitations of claim 15 as noted above.
Verard further teaches the temporary representation of the elongate device illustrates a position of the elongate device at a first time in a respiratory cycle of a patient (Paragraph [0117]; soft tissue navigation can benefit from gating or synchronizing to an anatomical function such as respiratory. image 228 had been acquired in the particular cycle… superimposed or virtual representation of the instrument 232 with the image 228 to generate a good match).
Regarding claim 18, together Verard, Viswanathan, Vertikov, and Hoeg teach all of the limitations of claim 15 as noted above.
Verard discloses the invention as claimed and discussed above, but fails to explicitly disclose the representation of the imaging probe extends beyond a distal end of the image of the elongate device.
Viswanathan, however, further teaches the image of the imaging probe extends beyond a distal end of the image of the elongate device (Paragraph [0018]; localized distal tip is graphically rendered in the X-ray view in the user interface... catheter that extends from the sheath; Paragraph [0040]; catheter has been positioned so that its distal tip portion 133 extends just beyond the sheath distal tip 132, Fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Verard in view of Viswanathan, Vertikov, and Hoeg such that the image of the imaging probe extends beyond a distal end of the image of the elongate device because it would aid the user determining where the catheter is positioned with respect to the sheath and thereby control the length of catheter extend from the sheath and thereby reduce the contact force exerted by the catheter tip (Paragraph [0039]).
Regarding claim 19, together Verard, Viswanathan, Vertikov, and Hoeg teach all of the limitations of claim 1 as noted above.
Verard discloses the invention as claimed and discussed above, but fails to explicitly disclose determining the position of the imaging probe marker in the virtual navigation view includes determining an insertion distance of the imaging probe.
Viswanathan, however, further teaches determining the position of the imaging probe marker in the virtual navigation view includes determining an insertion distance of the imaging probe (Paragraph [0032]; Thus, we define a total distance d as the sum of rigid tip length of the sheath and a margin-of-adjustment distance; sheath stays sufficiently away from the endocardial wall, and so that there is sufficient length for the ablation catheter (which extends from the sheath tip) to maneuver as needed and access a target).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Verard in view of Viswanathan, Vertikov, and Hoeg such that determining the position of the imaging probe marker in the virtual navigation view includes determining an insertion distance of the imaging probe because it would aid the user in determining where the catheter is positioned with respect to the sheath and thereby control the length of catheter extend from the sheath and thereby reduce the contact force exerted by the catheter tip (Paragraph [0039]).
Regarding claim 20, together Verard, Viswanathan, Vertikov, and Hoeg teach all of the limitations of claim 19 as noted above.
Verard further teaches a transducer of the imaging probe (Paragraph [0141]; catheter that includes an ultrasound transducer 298; Fig. 18 shows the transducer is at a distal tip portion of the imaging probe).
Viswanathan further teaches the insertion distance is measured from a distal end of the elongate device to a tip of the probe (Paragraph [0029]; process allows the user to identify the sheath distal tip at or near the point of entry into the chamber, which defines a reference position for the length of the catheter… drawn approximately from distal tip of the catheter (as seen on the X-ray image) to the distal tip of the sheath).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the insertion distance of Verard in view of Viswanathan, Vertikov, and Hoeg is measured from a distal end of the elongate device to a tip of the probe thereby being measured from a distal end of the elongate device to a transducer of the imaging probe because it would aid the user in determining where the catheter is positioned with respect to the sheath and thereby control the length of catheter extend from the sheath and thereby reduce the contact force exerted by the catheter tip (Paragraph [0039]) and further point at the target location to the best extent possible (Paragraph [0012]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Verard in view of Viswanathan and Hoeg as applied to claim 1 above, and further in view of Duindam-842 (WO 2018005842 A1).
Regarding claim 12, together Verard, Viswanathan, Vertikov, and Hoeg teach all of the limitations of claim 1 as noted above.
Together Verard, Viswanathan, Vertikov, and Hoeg do not explicitly teach the control system is further configured to adjust a preoperative target location to be within the orientation indicator.
Duindam-842, however, teaches a medical system (Paragraph [0007]; a system for displaying guidance information) comprising an imaging probe (Paragraph [0049]; Medical instrument 226 may include, for example, image capture probes, Fig. 2) and a control system (Paragraph [0053]; control system 116 of FIG. 1) configured to adjust a preoperative target location (Paragraph [0095]; displaying virtual global images in an alignment mode… a target location 1030; Paragraph [00118]; the target indicator is modeled based on preoperative voxel data) to be within an orientation indicator (Paragraph [0095]; a centerline 1027 from the distal end of elongate device 1020 is displayed; The target 1030 being in the centerline 1027 is considered to read on the claimed limitation of the preoperative target location being within the orientation indicator as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have configured the control system of Verard in view of Viswanathan, Vertikov, and Hoeg to have adjusted a preoperative target location to be within the orientation indicator as taught by Duindam-842 because it would have helped the operator visualize the insertion of a medical instrument, such as a biopsy needle, into target location.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Verard in view of Viswanathan, Vertikov, and Hoeg as applied to claim 8 above, and further in view of Simpson (US 20120253186).
Regarding claim 10, together Verard, Viswanathan, Vertikov, and Hoeg teach all of the limitations of claim 8 as noted above.
Together Verard, Viswanathan, Vertikov, and Hoeg do not explicitly teach the imaging probe marker includes a ring including an inner diameter and an outer diameter.
Simpson, however, teaches an imaging probe marker includes a ring including an inner diameter and an outer diameter (Paragraph [0111]; the middle of the image 820 represents the diameter of the catheter, and thus the area surrounding the circle 824 indicates the vessel, Fig. 7A and B; The OCT image from the imaging probe displayed next to the fluoroscopic image is considered to be an imaging probe marker including an inner diameter and outer diameter as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Verard in view of Viswanathan, Vertikov, and Hoeg to include an imaging probe marker includes a ring including an inner diameter and an outer diameter as taught by Simpson because it would allow the user to see the area of the vessel around the catheter in the region where the imaging probe is located in the fluoroscopic image, and thereby determine whether the probe has been navigated to a correct position.
Regarding claim 11, together Verard, Viswanathan, Vertikov, Hoeg, and Simpson teach all of the limitations of claim 10 as noted above.
Verard discloses the invention as claimed and discussed above, but fails to explicitly disclose the inner diameter of the imaging probe marker corresponds to an outer diameter of the imaging probe, and wherein the outer diameter of the imaging probe marker corresponds to a field of view of the imaging probe.
Simpson, however, further teaches the inner diameter of the imaging probe marker corresponds to an outer diameter of the imaging probe (Paragraph [0111]; The circle 824 in the middle of the image 820 represents the diameter of the catheter), and wherein the outer diameter of the imaging probe marker corresponds to an outer limit of the field of view of the imaging probe (Paragraph [0111]-[0112]; thus the area surrounding the circle 824 indicates the vessel; view 830 of the OCT image as it circles the radius of the body).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Verard in view of Viswanathan, Vertikov, Hoeg, and Simpson such that the inner diameter of the imaging probe marker corresponds to an outer diameter of the imaging probe, and wherein the outer diameter of the imaging probe marker corresponds to a field of view of the imaging probe as taught by Simpson because it would help the user in navigating by determining where the walls are in relation to the probe and thus assist in determining how to further position the probe (Paragraph [0116]-[0117]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Verard in view of Viswanathan, Vertikov, Hoeg, and Simpson as applied to claim 10 above, and further in view of Duindam-216 (WO 2018195216 A1).
Regarding claim 22, together Verard, Viswanathan, Vertikov, Hoeg, and Simpson teach all of the limitations of claim 10 as noted above.
Verard does not explicitly teach the control system is further configured to display the orientation indicator in the virtual navigation view, and wherein the orientation indicator is displayed as extending between the inner diameter and the outer diameter of the imaging probe marker.
Duindam-216, however, teaches a control system (Paragraph [0050]; Control system 112 may optionally further include a virtual visualization system to provide navigation assistance) configured to display the orientation indicator (Paragraph [0116]; supplemental guidance information… includes an arrow, Fig. 12A-B; Paragraph [0119]; supplemental guidance information 1310, Fig. 13) in the virtual navigation view (Paragraph [0119]; the rendered 3D model images may include supplemental guidance information, virtual distal view 1300, Fig. 13), and wherein the orientation indicator is displayed as extending between the inner diameter and the outer diameter (Paragraph [0116]; supplemental guidance information 1210 is displayed using a reticle that includes a circle with an arrow, Fig. 12A-B; The form of an arrow between the width of the circle is considered to read on the claimed limitation of displayed as extending between the inner diameter and the outer diameter as understood in its broadest reasonable interpretation) of the imaging probe marker (Paragraph [0120]; cross hair 1350 indicates the location an instrument, Fig. 13A-D).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Verard in view of Viswanathan, Vertikov, Hoeg, and Simpson to display the orientation indicator in the virtual navigation view, and wherein the orientation indicator is displayed as extending between the inner diameter and the outer diameter of the imaging probe marker as further taught by Duindam-216 because it would have been a known method of conveying information about the current direction and orientation of an imaging probe within a branching lumen that further would allow indication which branch to steer towards which would simplify steering of the probe.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Verard in view of Viswanathan, Vertikov, and Hoeg as applied to claim 1 above, and further in view of Duindam-216 (WO 2018195216 A1).
Regarding claim 23, together Verard, Viswanathan, Vertikov, and Hoeg teach all of the limitations of claim 1 as noted above.
Together Verard, Viswanathan, Vertikov, and Hoeg do not explicitly teach the orientation indicator is overlaid on the imaging probe marker in the virtual navigation view.
Duindam-216, however, teaches a control system (Paragraph [0050]; Control system 112 may optionally further include a virtual visualization system to provide navigation assistance) configured to display the orientation indicator (Paragraph [0116]; supplemental guidance information… includes an arrow, Fig. 12A-B; Paragraph [0119]; supplemental guidance information 1310, Fig. 13) overlaid on the imaging probe marker in the virtual navigation view (Paragraph [0116]; supplemental guidance information 1210 is displayed using a reticle that includes a circle with an arrow, Fig. 12A-B ; Paragraph [0119]; the rendered 3D model images may include supplemental guidance information, virtual distal view 1300, Fig. 13; The arrow over the circle reticle is considered to read on the claimed limitation of orientation indicator overlaid on the imaging probe marker as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Verard in view of Viswanathan, Vertikov, and Hoeg such that the orientation indicator is overlaid on the imaging probe marker in the virtual navigation view as taught by Duindam-216 because it would have been a known method of conveying information about the current direction and orientation of an imaging probe within a branching lumen that further would allow indication which branch to steer towards which would simplify steering of the probe.
Response to Arguments
Claim Rejections under – 35 U.S.C. § 103
Applicant’s arguments with respect to the previous 35 U.S.C. § 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dean N Edun whose telephone number is (571)270-3745. The examiner can normally be reached M-F 8am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anh Tuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEAN N EDUN/Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
7/23/26
Prosecution Insights