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 07/10/2026 has been entered. New claims 92-94 have been added. Claims 1-12, 14-22, 24-27, 29-30, 35-38, 43-45, and 92-94 remain pending in the application. Applicant’s amendments to the claims and abstract have overcome each and every objection previously set forth in the Non-Final Office Action mailed 03/12/2026.
Response to Arguments
Applicant’s arguments, see Remarks, filed 07/10/2026, with respect to the rejection of the claims under § 101 have been fully considered and are persuasive. The § 101 rejection of the claims have been withdrawn in view of the amendments made.
Applicant’s arguments with respect to claims rejected by reference Dascal have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Information Disclosure Statement
The information disclosure statement (IDS) submitted was filed on 08/14/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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 1-4, 7-8, 16-17, 19-20, 22, 24, 26, and 92-94 are rejected under 35 U.S.C. 103 as being unpatentable over Dascal (US20140270436) in view of Kiraly (US20130172732).
Regarding claim 1, Dascal teaches a method for displaying an object ([0164-0166], wherein information, e.g. objects, found in the OCT frames can be overlaid on the angiography screen; the overlays are the object), comprising:
acquiring intravascular data of a blood vessel of a patient using an intravascular device (30) positioned within the blood vessel; and extravascular data ([0070], and wherein intravascular images or data is acquired by an imaging catheter which traverses a blood vessel, [0091], “A catheter-based data collection probe 30 is introduced into the subject 10 and is disposed in the lumen of the particular blood vessel”);
acquiring a real-time stream of extravascular data of the blood vessel ([0009], “In one embodiment, frames of angiography are obtained in real time using a frame grabber”, [0066], wherein acquiring angiographic images comprises acquiring extravascular data, [0076], “During the pullback, a processor-based system, such as system 22 in FIG. 1, records live angiograms, and displays blood vessels”, [0088], “The angiography system 20 can include a fluoroscopy system”);
providing, on a display, the real-time stream of the extravascular data ([0076], “a processor-based system, such as system 22 in FIG. 1, records live angiograms, and displays blood vessels with a contrast agent and the marker or the probe”, [0165], “Since the OCT and angiography frames are registered, information found in the OCT frames can be overlaid on the angiography screen”);
registering the intravascular data with the extravascular data, thereby identifying a registered location within the extravascular data ([0015], “co-registering the angiography images and OCT images based on one or more of…matching of a feature in an OCT image with a feature in an angiography image”, [0024], “co-registering the plurality of frames of angiography image data and the plurality of frames of optical coherence tomography data using the tracked position”, [0163], [0165], “continued fluoroscopic imaging, co-registered to OCT”, [0156], “The co-registration software module produces a co-registration table of the acquisition's intravascular and external images that include the…position of each intravascular image/data point on each angiography image”); and
providing, on the display, the object in the real-time stream of the extravascular data, wherein a position of the object on the display corresponds to the registered location ([0165], “Since the OCT and angiography frames are registered, information found in the OCT frames can be overlaid on the angiography screen that the operator will use to place a stent. If side branches can be shown in the angiography view on a user interface, this can help avoid the unwanted caging of a side branch during stent deployment”, [0156], wherein the co-registration table includes “position of each intravascular image/data point on each angiography image”, [0164], “Further, once the co-registration is obtained…side branch detection…can be overlaid on the angiography image or the OCT images in light of the co-registration between the datasets”, [0166-0167], [0157]).
However, Dascal fails to teach determining an interpolation value based on a shift of the registered location between a first time point and a different, second time point within the real-time stream of the extravascular data; and adjusting, based on the interpolation value, the position of the object on the display while the real-time stream of the extravascular data is provided on the display.
In an analogous registration and display field of endeavor, Kiraly teaches such a feature. Kiraly teaches registering image overlays to real time fluoroscopic images ([0007], [0027-0028]). Kiraly teaches wherein the fluoroscopy images are real-time and 3D ([0013]). Kiraly teaches dynamically updating the overlay (22)/registration to account for motion ([0006-0007], [0022], [0027]). Kiraly teaches the motion of a catheter may be estimated by evaluating a shift of the catheter from a starting position to a new position in the live fluoroscopy images (Figs. 3-4, [0033]). Kiraly teaches the median point of the nearest points of intersection between two rays is taken as the new 3D position for estimating motion of the catheter ([0031]). Kiraly teaches the vector from the old position to the new position may then be used to shift the entire overlay in 3D ([0031]), wherein the vector comprises an interpolation value. Kiraly teaches the registration and overlay can be dynamically updated using the estimated motion (Fig. 3, [0029], [0033]). Kiraly teaches the overlays for fluoroscopic images are dynamically adjusted to compensate for motion of anatomical structures within the fluoroscopic images ([0013-0014]). Kiraly therefore teaches determining an interpolation value (vector from old position to new position, [0031]) and using it to adjust (shift) the position of an object (overlay) on the display while the real-time stream of the extravascular data (live fluoroscopy) is provided on the display.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to estimate motion and to correspondingly shift the overlay on the live fluoroscopic feed as taught by Kiraly (Figs. 3-4, [0006], [0013-0014], [0029], [0031], [0033]). Anatomic motions such as heart beating motions, breathing, and catheter motions may be accounted for by estimating a motion or shift of an object in a live feed and correspondingly shift the registration or overlays as recognized by Kiraly ([0006], [0013-0014]). A more accurate or useful visualization may be provided through dynamic overlay and registration as further recognized by Kiraly ([0034-0035]).
Regarding claim 2, Dascal in view of Kiraly teaches the invention as claimed above in claim 1.
Dascal further teaches wherein registering the intravascular data with the extravascular data comprises:
determining a feature within the intravascular data and a feature within the extravascular data ([0015], “matching of a feature in an OCT image with a feature in an angiography image”, [0163], wherein bifurcations are detected or determined on OCT images and angiography images); and
registering the feature within the intravascular data and the feature within the extravascular data ([0015], “co-registering the angiography images and OCT images based on one or more of… matching of a feature in an OCT image with a feature in an angiography image”, [0163]),
wherein at least one of the feature within the intravascular data or the feature within the extravascular data is manually selected ([0015], [0163], wherein the feature is bifurcations, [0146], wherein “…perform detection of nearest bifurcation anchor point 170l. This detection step can use the user selected point or hint point as an input…” comprises manually selecting the feature within the extravascular data (angiography image)).
Regarding claim 3, Dascal in view of Kiraly teaches the invention as claimed above in claim 2.
Dascal further teaches wherein the feature within the intravascular data and the feature within the extravascular data correspond to the registered location ([0156], co-registration table includes “radio-opaque marker's location on each angiography image; position of each intravascular image/data point on each angiography image”, [0162], “The co-registration table contains… all of the OCT/angiography cross-reference information necessary to drive the co-registration… OCT marker position information… the co-registration table associates the OCT frame index with the registered angiography frame index”, [0163], “For example, bifurcations detected on OCT images can be used as anchors with respect to bifurcations detected on angiography images”).
Regarding claim 4, Dascal teaches the invention as claimed above in claim 1.
Dascal further teaches wherein the registered location is automatically identified (Figs. 4A-4B & 5B, [0116], “The various steps and stages shown in FIG. 4A and FIG. 4B and as otherwise described herein can be performed automatically in whole or in part in various embodiments”, [0156], “software modules configured to automatically run and capture the angiography images and tag each image by its acquisition time support co-registration of intravascular data tagged with an acquisition time… automatically detects the radio-opaque marker on each angiography image corresponding to the intravascular acquisition… The co-registration software module produces a co-registration table”, [0151]).
Regarding claim 7, Dascal teaches the invention as claimed above in claim 1.
Dascal further teaches wherein the intravascular data comprises at least one image (Figs. 3A & 3B, [0007], “OCT images”, [0009], [0083]).
Regarding claim 8, Dascal teaches the invention as claimed above in claim 1.
Dascal further teaches wherein the extravascular data comprises at least one image (Figs. 3A & 3B, [0007], “angiography images”, [0009], [0083]).
Regarding claim 16, Dascal teaches the invention as claimed above in claim 1.
Dascal further teaches wherein the intravascular data comprises optical coherence tomography (OCT), intravascular ultrasound (IVUS), photoacoustic (PA), near infrared spectroscopy (NIRS), fluorescence, autofluorescence (AF), or any combination thereof ([0007], [0063-0064, [0072], wherein intravascular data comprises OCT and/or IVUS).
Regarding claim 17, Dascal teaches the invention as claimed above in claim 1.
Dascal further teaches wherein the intravascular data is detected by a multi-modal imaging system, wherein the multi-modal imaging system comprises the intravascular device (30) ([0064], “…some embodiments of the invention are suitable for handling multiple imaging modalities. Thus, in part, the invention relates to a multimodal diagnostic system”, [0072], [0091], “The probe 30 can be a variety of types of data collection probes such as for example an OCT probe, an FFR probe, an IVUS probe, a probe combining features of two or more of the foregoing, and other probes suitable for imaging within a blood vessel”, [0163]).
Regarding claim 19, Dascal teaches the invention as claimed above in claim 1.
Dascal further teaches wherein the intravascular data is detected by a one-dimensional sensing system, wherein the one-dimensional sensing system comprises the intravascular device (30) ([0062-0063], [0091], “A catheter-based data collection probe 30 is introduced into the subject 10 and is disposed in the lumen of the particular blood vessel…Additionally, the probe tip includes one or more data collecting subsystems such as an optical beam director, an acoustic beam director, a pressure detector sensor”, [0093], “The probe 30 can also be used to measure a particular parameter such as an FFR or other pressure measurement”, [0095], “For example, the data collection probe 30 can include one or more pressure sensors such as for example a pressure wire”, wherein pressure detector sensor which collects pressure data of a blood vessel comprises a one-dimensional sensing system).
Regarding claim 20, Dascal teaches the invention as claimed above in claim 19.
Dascal further teaches wherein the one-dimensional sensing system is a pressure sensing system ([0062-0063], [0091], [0095]).
Regarding claim 22, Dascal teaches the invention as claimed above in claim 1.
Dascal further teaches wherein the real-time stream of the extravascular data is streamed directly from an x-ray system (5; 20), without transfer over a network ([0009], “frames of angiography are obtained in real time using a frame grabber”, [0011], “an image data processing system that includes a frame grabber”, [0076], “records live angiograms, and displays blood vessels with a contrast agent and the marker or the probe”, [0088], [0089], “In one embodiment, the data processing relating to the collected angiography signal is performed directly on the detector of the angiography system 20. The images from system 20 are stored and managed by the angiography data storage and image management 22”, [0090], [0109], “a vessel centerline is generated by one or more software modules and superimposed or otherwise displayed relative to the angiography image”).
Regarding claim 24, Dascal teaches the invention as claimed above in claim 1.
Dascal further teaches wherein the extravascular data comprises x-ray, CT, magnetic resonance, ultrasound, fluoroscopy, or any combination of data thereof (Abstract, [0002-0003], [0088], [0090], [0165], wherein angiography images are acquired by fluoroscopy which uses x-rays).
Regarding claim 26, Dascal teaches the invention as claimed above in claim 1.
Dascal further teaches wherein the registered location is based on an a priori selection, annotations, or any combination thereof from prior patient records ([0163], wherein the registered locations are bifurcation points, [0125], wherein angiography images are preprocessed to obtain priori information, [0126-0129], [0146], wherein bifurcation points are detected priori and includes user selection).
Regarding claim 92, Dascal in view of Kiraly teaches the invention as claimed above in claim 1.
Dascal further teaches wherein the object is superimposed on the real-time stream of the extravascular data ([0164], “…can be overlaid on the angiography image”, [0165], [0167]).
Regarding claim 93, Dascal in view of Kiraly teaches the invention as claimed above in claim 1.
Dascal further teaches wherein the intravascular device (30) comprises a catheter ([0066-0067], [0070-0071], [0091], “A catheter-based data collection probe 30 is introduced into the subject 10 and is disposed in the lumen of the particular blood vessel”, [0092], “In addition, the probe 30 also includes the sheath such as a polymer sheath (not shown) which forms part of a catheter”).
Regarding claim 94, Dascal teaches a system for displaying an object ([0011], [0164-0168), comprising:
an intravascular device (30) configured to be positioned within a blood vessel (50) of a patient ([0071], [0091]); and
a processor (80) configured for communication with the intravascular device (30) and a display (82) (Fig. 1, [0076], [0080], [0094], “PIU 35 is connected to one or more intravascular data collection systems 40”, [0096], “One or more displays 82 can also be used to show an angiography frame of data, an OCT frame”, [0097], “data generated using the data collection probe 30 can be routed to the data collection processing system 40 coupled to the probe via PIU 35”, [0098], [0154], [0179], wherein figure 1 also shows the communication connections), wherein the processor (80) is configured to:
use the intravascular device (30) to acquire intravascular data of the blood vessel ([0011], [0179], [0070], and wherein intravascular images or data is acquired by an imaging catheter which traverses a blood vessel, [0091], “A catheter-based data collection probe 30 is introduced into the subject 10 and is disposed in the lumen of the particular blood vessel”);
acquire a real-time stream of extravascular data of the blood vessel ([0009], “In one embodiment, frames of angiography are obtained in real time using a frame grabber”, [0066], wherein acquiring angiographic images comprises acquiring extravascular data, [0076], “During the pullback, a processor-based system, such as system 22 in FIG. 1, records live angiograms, and displays blood vessels”, [0088], “The angiography system 20 can include a fluoroscopy system”, [0097], [0107], “Capturing images from both imaging modalities in real time”);
provide, on the display, the real-time stream of the extravascular data ([0076], “During the pullback, a processor-based system, such as system 22 in FIG. 1, records live angiograms, and displays blood vessels”, [0096], “One or more displays 82 can also be used to show an angiography frame of data”, [0165], “OCT frames can be overlaid on the angiography screen that the operator will use to place a stent”);
register the intravascular data with the extravascular data, thereby identifying a registered location within the extravascular data ([0024], “co-registering the plurality of frames of angiography image data and the plurality of frames of optical coherence tomography data using the tracked position”, [0156], “The co-registration software module produces a co-registration table of the acquisition's intravascular and external images that include…position of each intravascular image/data point on each angiography image”, [0162], “the table can include an entry which associates an OCT frame and angiography frame”, [0165], “continued fluoroscopic imaging, co-registered to OCT”);
provide, on the display, the object in the real-time stream of the extravascular data, wherein a position of the object on the display corresponds to the registered location ([0165], “Since the OCT and angiography frames are registered, information found in the OCT frames can be overlaid on the angiography screen that the operator will use to place a stent. If side branches can be shown in the angiography view on a user interface, this can help avoid the unwanted caging of a side branch during stent deployment”, [0156], wherein the co-registration table includes “position of each intravascular image/data point on each angiography image”, [0164], “Further, once the co-registration is obtained…side branch detection…can be overlaid on the angiography image or the OCT images in light of the co-registration between the datasets”, [0166-0167], [0157]).
However, Dascal fails to teach wherein the processor is configured to: determine an interpolation value based on a shift of the registered location between a first time point and a different, second time point within the real-time stream of the extravascular data; and adjust, based on the interpolation value, the position of the object on the display while the real-time stream of the extravascular data is provided on the display.
In an analogous registration and display field of endeavor, Kiraly teaches such a feature. Kiraly teaches registering image overlays to real time fluoroscopic images ([0007], [0027-0028]). Kiraly teaches wherein the fluoroscopy images are real-time and 3D ([0013]). Kiraly teaches dynamically updating the overlay (22)/registration to account for motion ([0006-0007], [0022], [0027]). Kiraly teaches the motion of a catheter may be estimated by evaluating a shift of the catheter from a starting position to a new position in the live fluoroscopy images (Figs. 3-4, [0033]). Kiraly teaches the median point of the nearest points of intersection between two rays is taken as the new 3D position for estimating motion of the catheter ([0031]). Kiraly teaches the vector from the old position to the new position may then be used to shift the entire overlay in 3D ([0031]), wherein the vector comprises an interpolation value. Kiraly teaches the registration and overlay can be dynamically updated using the estimated motion (Fig. 3, [0029], [0033]). Kiraly teaches the overlays for fluoroscopic images are dynamically adjusted to compensate for motion of anatomical structures within the fluoroscopic images ([0013-0014]). Kiraly therefore teaches determining an interpolation value (vector from old position to new position, [0031]) and using it to adjust (shift) the position of an object (overlay) on the display while the real-time stream of the extravascular data (live fluoroscopy) is provided on the display. Kiraly further teaches wherein a processor may manipulate the images for the adjustment of the overlays ([0014]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to have the processor be configured to: estimate motion and to correspondingly shift the overlay on the live fluoroscopic feed as taught by Kiraly (Figs. 3-4, [0006], [0013-0014], [0029], [0031], [0033]). Anatomic motions such as heart beating motions, breathing, and catheter motions may be accounted for by estimating a motion or shift of an object in a live feed and correspondingly shift the registration or overlays as recognized by Kiraly ([0006], [0013-0014]). A more accurate or useful visualization may be provided through dynamic overlay and registration as further recognized by Kiraly ([0034-0035]).
Claims 5-6, 25, 35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Dascal (US20140270436) in view of Kiraly (US20130172732) as applied to claim 1 above, and further in view of Venkatraghavan (US20160196666).
Regarding claim 5, Dascal in view of Kiraly teaches the invention as claimed above in claim 1.
However, Dascal fails to teach wherein the object comprises a first object and a second object, wherein the first object and the second object are provided in the real-time stream of the extravascular data relative to the registered location.
In an analogous registration and display field of endeavor, Venkatraghavan teaches such a feature. Venkatraghavan teaches registration of intravascular ultrasound (IVUS) images with angiographic images ([0294]). Venkatraghavan teaches tracking one or more markers on a lumen assessment device (Claim 1, [0087]). Venkatraghavan teaches superimposing demarcation positions (positions A and B) and one or more markers upon an image of the body lumen, i.e. blood vessel (Fig. 50B, Claim 25, [0287]). Venkatraghavan therefore teaches a first and second object are displayed (wherein two markers or demarcation positions A and B of a lesion are superimposed) relative to extravascular data (wherein the image of the body lumen is an angiogram, Fig. 50B, [0284], [0287]). As shown in figure 50B the plurality of markers or positions A and B (demarcations of a lesion) are superimposed relative to an extravascular data comprising an angiogram and is thus displayed relative to any feature or registered location in said extravascular data. Dascal teaches wherein the extravascular data comprises a real-time angiography stream ([0009], [0076], [0088]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to have the object comprise a plurality of tracked markers or demarcations of a lesion superimposed on extravascular data as taught by Venkatraghavan (Fig. 50B, [0287], claim 25). Tracking and display of the plurality of markers or demarcations of a lesion may help with delivery and deployment of a stent as recognized by Venkatraghavan (Fig. 50B, [0284], [0287]). Dascal teaches wherein the extravascular data are live angiograms acquired in real-time using a fluoroscopy system ([0009], [0076], [0088]). Modifying Dascal with the teachings of Venkatraghavan would predictably result in superimposing a plurality of markers or demarcations of a lesion on the live real-time stream of extravascular angiographic images, the markers/demarcations being displayed relative to a registered location within the extravascular/angiographic images.
Regarding claim 6, Dascal in view of Kiraly teaches the invention as claimed above in claim 1.
However, Dascal fails to explicitly teach the invention further comprising determining a location to guide positioning of a foreign object.
In an analogous registration and display field of endeavor, Venkatraghavan teaches such a feature. Venkatraghavan teaches registration of intravascular ultrasound (IVUS) images with angiographic images ([0294]). Venkatraghavan teaches tracking one or more markers on a lumen assessment device (Claim 1, [0087]). Venkatraghavan teaches using contrast to show on an angiogram the location of a lesion/blockage where a stent needs to be placed ([0284]). Venkatraghavan teaches advancing or guiding the stent delivery catheter to the point of interest and positioning it in place by using the angiographic image as guidance ([0284]). Venkatraghavan therefore teaches determining a location (lesion/blockage) to guide positioning of a foreign object (stent).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to determine the location of a lesion or blockage where a stent needs to be placed as recognized by Venkatraghavan ([0284]). By determining the location of the blockage, the stent may predictably be delivered to the blockage to widen the vessel, thereby improving the health of the patient or subject.
Regarding claim 25, Dascal in view of Kiraly teaches the invention as claimed above in claim 1.
However, Dascal fails to teach the invention further comprising measuring heart cycle data from an external ECG signal, intravascular data, extravascular data, or any combination thereof, wherein the heart cycle data is used to improve an accuracy of the registered location within the extravascular data.
In an analogous registration and display field of endeavor, Venkatraghavan teaches such a feature. Venkatraghavan teaches registration of intravascular ultrasound (IVUS) images with angiographic images ([0294]). Venkatraghavan teaches measuring lumen trajectory variation across different phases or points in the heart cycle (Figs. 30-31, [0082-0084]). Venkatraghavan teaches wherein ECG may be used to identify the phase of the heart beat within a heart cycle which an angiographic frame is recorded ([0088]). Venkatraghavan teaches wherein live fluoroscopic images (real-time extravascular data) may be co-registered with a reference angiogram (extravascular data) based on phases of the heart cycle, thereby compensating for motion due to the heart cycle (Claim 15, [0217]). Moreover, Venkatraghavan teaches wherein each recorded image frame recorded with IVUS may be mapped to a corresponding angiographic frame based on the phase of the heartbeat ([0294]), thereby also teaching registering intravascular data with extravascular data based on heart cycle data, resulting in improved accuracy of registration and thus registered locations.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to have ECG track the heart cycle and compensate for motion due to the heart cycle in registration as taught by Venkatraghavan (Claim 15, [0088], [0217], [0294]). Motion artifacts may predictably be corrected for by taking into account of motion from the heart cycle as recognized by Venkatraghavan ([0217]).
Regarding claim 35, Dascal in view of Kiraly and Venkatraghavan teaches the invention as claimed above in claim 5.
However, Dascal fails to teach wherein at least one of the first object or second object is provided in the real-time stream of the extravascular data in one or more views.
In an analogous registration and display field of endeavor, Venkatraghavan teaches such a feature. Venkatraghavan teaches registration of intravascular ultrasound (IVUS) images with angiographic images ([0294]). Venkatraghavan teaches wherein a user may demarcate a lesion and wherein the demarcations (positions A and B) may be superimposed in both static and live angiograms (Fig. 50B, [0287]), wherein positions A and B comprise first and second objects. Venkatraghavan therefore teaches wherein a first object or second object is displayed superimposed on or provided in real-time extravascular data in at least one view (Fig. 50B, [0287]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to display the demarcations of lesion on live angiograms as taught by Venkatraghavan (Fig. 50B, [0287]). The demarcations may help a user position a balloon catheter as recognized by Venkatraghavan ([0287]).
Regarding claim 37, Dascal in view of Kiraly and Venkatraghavan teaches the invention as claimed above in claim 35.
Dascal further teaches wherein a view of the one or more data views comprises a zoom view ([0078], “The magnifying glass icon can be used to zoom in or out on either the OCT or angiography image”).
Claim 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Dascal (US20140270436) in view of Kiraly (US20130172732) as applied to claim 1 above, and further in view of Kunio (US20220346885).
Regarding claim 9, Dascal in view of Kiraly teaches the invention as claimed above in claim 1.
However, Dascal fails to teach wherein the registered location, a location within the intravascular data, a location within the extravascular data, or any combination of locations thereof are determined by a predictive model.
In an analogous method of registering intravascular data with extravascular data field of endeavor, Kunio teaches such a feature. Kunio teaches registering angiography images with ether optical coherence tomography (OCT) images or intravascular ultrasound (IVUS) images ([0023]). Kunio teaches using a predictive model to identify and predict marker locations in angiography image frames ([0013-0014], “In one or more embodiments, a model…trained on data to make one or more predictions… to predict the marker location”). Moreover, Kunio teaches wherein the model comprises a machine learning model ([0013], [0018]). Kunio further teaches wherein the model may comprise a neural network algorithm ([0021], [0027], [0111-0112], [0173]). Kunio therefore teaches determining a location (marker location) within the extravascular data (angiography images) with a predictive model.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to use a predictive model to identify marker locations as taught by Kunio ([0013-0014]). By using a predictive model, marker locations may be identified more accurately to perform co-registration more efficiently as recognized by Kunio ([0011-0012]).
Regarding claim 10, Dascal in view of Kiraly and Kunio teaches the invention as claimed above in claim 9.
However, Dascal fails to teach wherein the predictive model comprises a machine learning model.
In an analogous method of registering intravascular data with extravascular data field of endeavor, Kunio teaches such a feature. Kunio teaches registering angiography images with ether optical coherence tomography (OCT) images or intravascular ultrasound (IVUS) images ([0023]). Kunio teaches using a predictive model to identify and predict marker locations in angiography image frames ([0013-0014], “In one or more embodiments, a model…trained on data to make one or more predictions… to predict the marker location”). Moreover, Kunio teaches wherein the model comprises a machine learning model ([0013], [0018]). Kunio further teaches wherein the model may comprise a neural network algorithm ([0021], [0027], [0111-0112], [0173]). Kunio therefore teaches wherein the predictive model comprises a machine learning model.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to use a machine learning model to identify marker locations as taught by Kunio ([0013-0014]). By using a machine learning model, marker locations may be identified more accurately to perform co-registration more efficiently as recognized by Kunio ([0011-0012]).
Regarding claim 11, Dascal in view of Kiraly and Kunio teaches the invention as claimed above in claim 10.
However, Dascal fails to teach wherein the machine learning model comprises a neural network algorithm.
In an analogous method of registering intravascular data with extravascular data field of endeavor, Kunio teaches such a feature. Kunio teaches registering angiography images with ether optical coherence tomography (OCT) images or intravascular ultrasound (IVUS) images ([0023]). Kunio teaches using a predictive model to identify and predict marker locations in angiography image frames ([0013-0014], “In one or more embodiments, a model…trained on data to make one or more predictions… to predict the marker location”). Moreover, Kunio teaches wherein the model comprises a machine learning model ([0013], [0018]). Kunio further teaches wherein the model may comprise a neural network algorithm ([0021], [0027], [0111-0112], [0118-0119], [0173]). Kunio therefore teaches wherein machine learning model comprises a neural network algorithm.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to have the machine learning model comprise a neural network algorithm as taught by Kunio ([0021], [0027], [0111-0112], [0118-0119], [0173]). Success rate of marker detection may be improved using a neural network model as recognized by Kunio ([0118-0119]), thereby improving co-registration efficiency.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Dascal (US20140270436) in view of Kiraly (US20130172732) as applied to claim 1 above, and further in view of Baldauf (US20180310992).
Regarding claim 12, Dascal in view of Kiraly teaches the invention as claimed above in claim 1.
However, Dascal fails to teach wherein the blood vessel comprises a coronary artery, further comprising guiding a catheter through the coronary artery to the object to treat coronary artery disease.
In an analogous intravascular field of endeavor, Baldauf teaches such a feature. Baldauf teaches reconstruction of an arterial lumen using intravascular data such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT) ([0027]). Moreover, Baldauf teaches observing or displaying markers of a catheter (100) on an angiogram ([0028-0029]). Baldauf teaches treatment of coronary artery disease (CAD) comprises insertion of a catheter and stent into a coronary artery ([0003-0004]). Baldauf teaches threading a catheter onto a guidewire and directing the catheter through a coronary artery to a location of interest such as stenosis ([0032]). Since the stenosis is a location for treating CAD, Baldauf therefore teaches guiding a catheter through a coronary artery to an object (blood vessel/stenosis) to treat coronary artery disease.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to guide a catheter to a stenosis in a coronary artery to treat coronary artery disease and thus have the blood vessel comprise the coronary artery as taught by Baldauf ([0003-0004], [0032]). By guiding a catheter to a stenosis of the coronary artery, a stent may be placed at the stenosis using the catheter, thereby holding the artery open and improving patient health as recognized by Baldauf ([0004]). Moreover, because the catheter is guided toward the coronary artery, the intravascular data would predictably result in being of said coronary artery for guidance thereof.
Claims 14-15 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Dascal (US20140270436) in view of Kiraly (US20130172732) as applied to claim 1 above, and further in view of Fan (US20140236011).
Regarding claim 14, Dascal in view of Kiraly teaches the invention as claimed above in claim 1.
However, Dascal fails to teach wherein the blood vessel comprises a coronary artery, guiding the intravascular device through the coronary artery to the object to diagnose coronary artery disease.
In an analogous intravascular field of endeavor, Fan teaches such a feature. Fan teaches methods for accurate diagnosis of coronary artery disease ([0018]). Fan teaches calculating fractional flow reserve across a stenosis in a blood vessel (102) (FFR) ([0042-0043], [0052-0053]). Fan teaches, conventionally, passing a transducer of a FFR catheter across a coronary lesion and calculating FFR ([0053]). Fan teaches an integrated device (300) including a catheter (104) configured to measure FFR in a blood vessel (102) (i.e. coronary artery) (Fig. 3, [0011], [0042-0043], [0046-0047]). Fan therefore teaches guiding an intravascular device comprising a catheter through a coronary artery (wherein FFR catheter is guided to a coronary lesion) to an object (lesion) to diagnose coronary artery disease.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to guide a catheter through a coronary artery to calculate fractional flow reserve (FFR) as taught by Fan (Fig. 3, [0011], [0018], [0042-0043], [0046-0047], [0052-0053]). By guiding a catheter to a coronary artery, lesion, or blockage, FFR may be calculated and be predictably used to diagnose coronary artery disease (CAD), and diagnosing CAD may predictably improve patient outcomes.
Regarding claim 15, Dascal in view of Kiraly teaches the invention as claimed above in claim 1.
However, Dascal fails to teach the intravascular device is configured to measure fractional flow reserve of the blood vessel.
In an analogous intravascular field of endeavor, Fan teaches such a feature. Fan teaches methods for accurate diagnosis of coronary artery disease ([0018]). Fan teaches calculating fractional flow reserve across a stenosis in a blood vessel (102) (FFR) ([0042-0043], [0052-0053]). Fan teaches, conventionally, passing a transducer of a FFR catheter across a coronary lesion and calculating FFR ([0053]). Fan teaches an intravascular device (300) comprising a catheter (104) configured to measure FFR in a blood vessel (102) (i.e. coronary artery) (Fig. 3, [0011], [0042-0043], [0046-0047], [0052], [0054], [0070-0071]). Fan therefore teaches an intravascular device comprising a catheter configured to measure fractional flow reserve of a blood vessel comprising coronary artery.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to have the intravascular device be configured to measuring fractional flow reserve (FFR) of a blood vessel as taught by Fan (Fig. 3, [0011], [0042-0043], [0046-0047], [0054], [0070-0071]). FFR is a diagnostic parameter that may provide indication of a pathological condition, such as coronary artery disease, as recognized by Fan ([0018], [0070]).
Regarding claim 21, Dascal in view of Kiraly teaches the invention as claimed above in claim 1.
However, Dascal fails to teach wherein the intravascular data comprises a measure of flow.
In an analogous intravascular field of endeavor, Fan teaches such a feature. Fan teaches a system (100) including a catheter (104) having a flow sensor (107) for measuring blood flow through a blood vessel (102) ([0021-0022]). Fan teaches wherein the system may be implemented as an IVUS, OCT, or ICE system ([0020]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to measure blood flow as taught by Fan ([0021-0022]). Measuring of blood flow through a vessel may predictably be used to diagnose the health of the vessel.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Dascal (US20140270436) in view of Kiraly (US20130172732) as applied to claim 17 above, and further in view of Muller (US20090299195).
Regarding claim 18, Dascal in view of Kiraly teaches the invention as claimed above in claim 17.
However, Dascal fails to teach wherein the multi-modal imaging system comprises a combined optical coherence tomography (OCT) and near infrared spectroscopy (NIRS) imaging system.
In an analogous intravascular field of endeavor, Muller teaches such a feature. Muller teaches a multimodal catheter system for intravascular analysis (Title). Muller teaches a single catheter combining multiple diagnostic modalities ([0014]). Muller teaches wherein the catheter (100) is configured to collect OCT and NIR data for analysis ([0016], [0046-0049], [0052], [0055-0057], [0067-0068]). Muller further teaches registration of angiography with other imaging modalities such as NIR, OCT, IVUS ([0017], [0072]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to configure the catheter for OCT and NIRS as taught by Muller ([0016], [0046-0049], [0052], [0055-0057], [0067-0068]). A catheter or imaging system which combines both NIRS and OCT may provide a physician with more comprehensive data set to formulate a therapy decision as recognized by Muller ([0015-0016]).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Dascal (US20140270436) in view of Kiraly (US20130172732) as applied to claim 1 above, and further in view of Strommer (US20050107688) and Venkatraghavan (US20160196666).
Regarding claim 27, Dascal in view of Kiraly teaches the invention as claimed above in claim 1.
Dascal further teaches the real-time stream of the extravascular data is displayed ([0076], wherein angiograms are recorded live and displayed).
However, Dascal fails to teach wherein the object comprises a fiducial marker.
In an analogous method of displaying of an object field of endeavor, Strommer teaches such a feature. Strommer teaches displaying of a real-time 2D image (104) via x-ray fluoroscopy or angiogram (Fig. 1A, [0062-0063]). Strommer further teaches wherein fiducial markers attached to a catheter may be displayed on the real-time image (104) of the lumen (108) ([0070]). Strommer therefore teaches wherein the displayed object is a fiducial marker and wherein the marker is displayed on a real-time extravascular data/image.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to have the displayed object be fiducial markers as taught by Strommer ([0070]). By displaying fiducial markers attached to an instrument, an operator may continue to use the real-time image for guidance even with little to no contrast as recognized by Strommer ([0070]).
However, the modified combination noted above fails to teach wherein the position of the object is adjusted to account for motion artifacts.
In an analogous registration and display field of endeavor, Venkatraghavan teaches such a feature. Venkatraghavan teaches registration of intravascular ultrasound (IVUS) images with angiographic images ([0294]). Venkatraghavan teaches tracking one or more markers on a lumen assessment device (Claim 1, [0087]). Venkatraghavan teaches superimposing the one or more markers upon an image of the body lumen, i.e. blood vessel (Fig. 50B, Claim 25, [0287]). Venkatraghavan teaches mapping or registering a detected position of a device onto an image after compensating for motion due to heart beat, breathing, and other minor movements ([0072]). Venkatraghavan teaches the position of the device is based on the markers ([0130]). Venkatraghavan teaches compensating for motion of the markers of the instrument during registration (Claim 1, [0225]). Venkatraghavan therefore teaches correcting a spatial position of a device and its markers to account for motion artifacts.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal in view of Strommer to correct the position of objects, i.e. device and its markers, for motion artifacts as taught by Venkatraghavan (Claim 1, [0072] [0130], [0225]). By compensating for motion artifacts due to heart beat, breathing, and the like, a more accurate registration and depiction/display of objects may predictably be obtained.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Dascal (US20140270436) in view of Kiraly (US20130172732) as applied to claim 1 above, and further in view of Cohen (US20230181140).
Regarding claim 29, Dascal in view of Kiraly teaches the invention as claimed above in claim 1.
However, Dascal fails to teach the invention further comprising measuring a distance from a catheter to the object.
In an analogous registration of intravascular data to extravascular data field of endeavor, Cohen teaches such a feature. Cohen teaches registering imaging data from an intravascular imaging catheter to locations in an x-ray image (Abstract, [0006]). Cohen teaches measuring the distance from a catheter to a vessel wall (object) ([0135]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to measure a distance from a catheter to a vessel wall as taught by Cohen ([0135]). By measuring the distance, lines may be drawn estimating vessel wall location, thereby helping visualization of the vessel wall to a user for guidance as recognized by Cohen (Fig. 12, [0135]).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Dascal (US20140270436) in view of Kiraly (US20130172732) and Cohen (US20230181140) as applied to claim 29 above, and further in view of Lu (US20220175269).
Regarding claim 30, Dascal in view of Kiraly and Cohen teaches the invention as claimed above in claim 29.
However, Dascal fails to explicitly teach wherein the measured distance from the catheter to the object is displayed in real time with a visual representation.
In an analogous method comprising acquiring of extravascular data field of endeavor, Lu teaches such feature. Lu teaches acquiring and displaying x-ray angiogram images of coronary vessels ([0028], [0102], [0116]). Lu teaches distance measurements may be integrated with angiogram vasculature imaging ([0260]). Lu teaches wherein distance measurements can be calculated and displayed in real-time ([0260]). Lu therefore teaches displaying distance measurements in real time, and wherein displaying implies visual representation.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal in view of Cohen to display the distance measurements in real time as taught by Lu ([0260]). Display of real time distance data may predictably help a user with guidance of the catheter in real time for a procedure.
Claims 36 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Dascal (US20140270436) in view of Kiraly (US20130172732) and Venkatraghavan (US20160196666) as applied to claim 35 above, and further in view of Millett (US20140187920).
Regarding claim 36, Dascal in view of Kiraly and Venkatraghavan teaches the invention as claimed above in claim 35.
However, Dascal fails to teach wherein a first view of the one or more data views comprises a display of the real-time stream of the extravascular data without a display of at least one of the first object or the second object, and wherein a second view of the one or more data views comprises a display of the real-time stream of the extravascular data with a display of at least one of the first object or the second object.
In an analogous registration of intravascular data to extravascular data field of endeavor, Millett teaches such a feature. Millet teaches co-registration of intravascular data with angiographic images ([0047]). Millett teaches a user is able to select what information should be included or excluded from a displayed image ([0066]). Millett teaches a user may select visualization modes ([0066]). Millett teaches wherein a user may either show or hide various data such as graphs, data, or overlaid data ([0066]). Millett therefore teaches a first and second view, wherein a first view may hide objects and wherein a second view may show objects.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to have a user be able to hide or show certain objects or data on a displayed image as taught by Millett ([0066]). Hiding or showing data may be useful when relevant data is needed or isn’t needed and the image needs to clearer/less obscured by the data.
Regarding claim 38, Dascal in view of Kiraly and Venkatraghavan teaches the invention as claimed above in claim 35.
However, Dascal fails to teach wherein providing the first object or the second object relative to the registered location comprises: a first state in which at least one of the first object or the second object is visible; or a second state in which at least one of the first object or the second object is not visible.
In an analogous registration of intravascular data to extravascular data field of endeavor, Millett teaches such a feature. Millet teaches co-registration of intravascular data with angiographic images ([0047]). Millett teaches a user is able to select what information should be included or excluded from a displayed image ([0066]). Millett teaches a user may select visualization modes ([0066]). Millett teaches wherein a user may either show or hide various data such as graphs, data, or overlaid data ([0066]). Millett therefore teaches first and second states, wherein a first state may display objects and wherein a second state may hide objects, such as overlaid data.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to have a user be able to show or hide certain objects or data on a displayed image as taught by Millett ([0066]). Showing and hiding data may be useful when relevant data is needed or isn’t needed and the image needs to clearer/less obscured by the data.
Claims 43 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Dascal (US20140270436) in view of Kiraly (US20130172732) as applied to claim 1 above, and further in view of Simaan (US20240277423).
Regarding claim 43, Dascal in view of Kiraly teaches the invention as claimed above in claim 1.
Dascal teaches wherein real-time stream of the extravascular data is angiograms ([0009], [0076], “…records live angiograms, and displays blood vessels”).
However, Dascal fails to teach the invention further comprising displaying an indicator, wherein the indicator comprises a metric representing a distance between the object and a target location within the real-time stream of the extravascular data.
In an analogous acquiring of extravascular data field of endeavor, Simaan teaches such a feature. Simaan teaches displaying a color bar with a numerical distance indicator, wherein the color bar changes color as a catheter tip (object) approaches a target and is representative of the distance between the catheter and target (Claim 6, [0085]). Simaan teaches wherein the target may comprise a clot or aneurysm wall and wherein the location of the target is deduced from an angiogram, therefore teaching wherein the target is a target location within an angiogram (Fig. 1, [0003], [0033]). Dascal above teaches wherein the real-time extravascular data comprises live angiograms.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to display a numerical indicator indicating a distance between a tip of a catheter to a target as recognized by Simaan (Claim 6, [0085]). The distance indicator may predictably help a user know how much further to advance the catheter to said target for treatment.
Regarding claim 44, Dascal in view of Kiraly and Simaan teaches the invention as claimed above in claim 43.
However, Dascal fails to teach wherein the target location is determined by at least one intravascular image or at least one extravascular image.
In an analogous acquiring of extravascular data field of endeavor, Simaan teaches such a feature. Simaan teaches displaying a color bar with a numerical distance indicator, wherein the color bar changes color as a catheter tip (object) approaches a target and is representative of the distance between the catheter and target (Claim 6, [0085]). Simaan teaches wherein the target may comprise a clot or aneurysm wall and wherein the location of the target is deduced from an angiogram (Fig. 1, [0003], [0033]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to derive the target location from extravascular data as taught by Simaan (Fig. 1, [0003], [0033]). A location of a clot may be deduced from the absence of contrast in an angiogram as recognized by Simaan ([0033]), allowing for using a catheter to remove said clot via aspiration/vacuum as further recognized by Simaan ([0005]).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Dascal (US20140270436) in view of Kiraly (US20130172732) and Venkatraghavan (US20160196666) as applied to claim 35 above, and further in view of Weese (US20080192887).
Regarding claim 45, Dascal in view of Kiraly Venkatraghavan teaches the invention as claimed above in claim 35.
However, Dascal fails to teach the invention further comprising: processing a vessel geometry of the extravascular data and displaying the processed vessel geometry in a view of the one or more data views.
In an analogous method including acquiring of extravascular data field of endeavor, Weese teaches such a feature. Weese teaches extracting features related to vessel geometry from X-ray projections ([0007], wherein x-ray projections comprise extravascular data). Weese teaches a data processing unit adapted to reconstruct a three-dimensional model of vessel geometry (Claim 1, [0005], [0017]). Weese teaches displaying the reconstructed vessel geometry (Claim 11, [0025]). Weese therefore teaches processing (reconstructing) a vessel geometry of the extravascular data (x-ray projections of the vessel system) and displaying the processed (reconstructed) vessel geometry in a view of the one or more data views, wherein a view is implied from displaying.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Dascal to reconstruct and display vessel geometry as taught by Weese (Claims 1 & 11, [0005], [0007], [0017], [0025]). Processing and display of vessel geometry may predictably help a user guide a catheter or instrument through the vessel for diagnosis or treatment.
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 TOMMY T LY whose telephone number is (571) 272-6404. The examiner can normally be reached M-F 12:00pm-8:00pm eastern time.
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/TOMMY T LY/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797
