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
This office action is in response to the communications filed on 04/29/2026, concerning Application No. 18/075,561. The amendments to the claims filed on 04/29/2026 are acknowledged. Presently, claims 1-6, 9-12, 16, 18-19, and 21-24 remain pending.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 10-12, 16, 19, and 21-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chao et al. (US 2020/0129142 A1, of record, cited in the applicant’s IDS filed on 04/18/2023, hereinafter Chao).
Regarding claims 1 and 16, Chao discloses a system (intraluminal imaging system 100) and a corresponding method, the system (100) comprising:
an intravascular imaging catheter (intraluminal device 102) configured for movement through a blood vessel (vessel/lumen 120) with a blockage to blood flow, wherein the intravascular imaging catheter (102) comprises intravascular ultrasound (IVUS) or optical coherence tomography (OCT) (see, e.g., Para. [0047], “intraluminal imaging is carried out with an IVUS device including one or more ultrasound transducers. The IVUS device may be passed into the vessel and guided to the area to be imaged. The transducers emit ultrasonic energy and receive ultrasound echoes reflected from the vessel. The ultrasound echoes are processed to create an image of the vessel of interest. The image of the vessel of interest may include one or more lesions or blockages in the vessel and/or sites of narrowing by compression. A stent may be placed within the vessel to treat these blockages or narrowings, and intraluminal imaging may be carried out to view the placement of the stent within the vessel”, and Para. [0053], “FIG. 1 is a diagrammatic schematic view of an intraluminal imaging system incorporating the IVUS pullback virtual venogram system, according to aspects of the present disclosure. The intraluminal imaging system 100 can be an intravascular ultrasound (IVUS) imaging system in some embodiments. The intraluminal imaging system 100 may include an intraluminal device 102 […] The intraluminal device 102 is sized and shaped, and/or otherwise structurally arranged to be positioned within a body lumen of a patient. For example, the intraluminal device 102 can be a catheter, guide wire, guide catheter, pressure wire, and/or flow wire in various embodiments”, and Para. [0054], “The intraluminal imaging system 100 (or intravascular imaging system) can be any type of imaging system suitable for use in the lumens or vasculature of a patient. In some embodiments, the intraluminal imaging system 100 is an intraluminal ultrasound (IVUS) imaging system”, and Para. [0055], “the device 102 may include an imaging component of any suitable imaging modality, such as optical imaging, optical coherence tomography (OCT), etc. […] the device 102 can include an imaging element to obtain intraluminal imaging data associated with the lumen 120. The device 102 may be sized and shaped (and/or configured) for insertion into a vessel or lumen 120 of the patient”); and
a processor circuit (processing system 106) configured for communication with the intravascular imaging catheter (102) (see, e.g., Para. [0053], “The intraluminal imaging system 100 can be an intravascular ultrasound (IVUS) imaging system in some embodiments. The intraluminal imaging system 100 may include an intraluminal device 102, a patient interface module (PIM) 104, a console or processing system 106…”, and Para. [0057], “The intraluminal device 102, PIM 104, monitor 108, and external imaging system 132 may be communicatively coupled directly or indirectly to the processing system 106”, and Para. [0061], “The PIM 104 facilitates communication of signals between the processing system 106 and the scanner assembly 110 included in the intraluminal device 102”), wherein the processor circuit (106) is configured to:
control the intravascular imaging catheter (102) to obtain a plurality of intravascular images during the movement (see, e.g., Abstract, “Disclosed is an intraluminal ultrasound imaging system, comprising a processor circuit in communication with an intraluminal ultrasound imaging catheter, and configured to receive an intraluminal ultrasound image from the imaging catheter within a body lumen of a patient”, and Para. [0055], “the device 102 may include an imaging component of any suitable imaging modality, such as optical imaging, optical coherence tomography (OCT), etc. […] the device 102 can include an imaging element to obtain intraluminal imaging data associated with the lumen 120. The device 102 may be sized and shaped (and/or configured) for insertion into a vessel or lumen 120 of the patient”, and Para. [0062], “The processing system 106 receives echo data from the scanner assembly 110 by way of the PIM 104 and processes the data to reconstruct an image of the tissue structures in the medium surrounding the scanner assembly 110. Generally, the device 102 can be utilized within any suitable anatomy and/or body lumen of the patient. The processing system 106 outputs image data such that an image of the vessel or lumen 120, such as a cross-sectional IVUS image of the lumen 120”);
determine, based on the plurality of intravascular images, a plurality of plaque burdens along a length of the blood vessel (see, e.g., Para. [0095], “FIG. 13 illustrates a screen display during review of the IVUS images obtained during the pullback. The roadmap, longitudinal image, or virtual venogram 500 of the vasculature shows all of the bookmarked frames and labels 1310 (e.g., vasculature segment abbreviation, target frame, reference frame, frame representative of diseased or compressed vasculature, frame representative of vasculature that needs treatment, frame representative of healthy vasculature, etc.) The processing system 106 performs automatic image analysis of the obtained IVUS image data and calculates one or more metrics (e.g., cross-sectional lumen area, diameter, compression, plaque burden, etc.) A graphical representation 1320 of the automatically calculated metrics is shown on the roadmap image of the vasculature, e.g., adjacent to the vasculature. For example, the graphical representation can be a bar (such as in a bar graph) or a histogram representative of the value corresponding to adjacent portion of the vasculature” (emphasis herein added));
identify, based on the plurality of plaque burdens, a location of the blockage along the length of the blood vessel (see, e.g., Para. [0041], “The present disclosure relates generally to medical imaging, including imaging associated with a body lumen of a patient using an intraluminal imaging device. For example, the present disclosure describes systems, devices, and methods for determining and marking the location of an intravascular imaging probe within a patient's vasculature”, and Para. [0095], “FIG. 13 illustrates a screen display during review of the IVUS images obtained during the pullback. The roadmap, longitudinal image, or virtual venogram 500 of the vasculature shows all of the bookmarked frames and labels 1310 (e.g., vasculature segment abbreviation, target frame, reference frame, frame representative of diseased or compressed vasculature, frame representative of vasculature that needs treatment, frame representative of healthy vasculature, etc.) The processing system 106 performs automatic image analysis of the obtained IVUS image data and calculates one or more metrics (e.g., cross-sectional lumen area, diameter, compression, plaque burden, etc.) A graphical representation 1320 of the automatically calculated metrics is shown on the roadmap image of the vasculature, e.g., adjacent to the vasculature. For example, the graphical representation can be a bar (such as in a bar graph) or a histogram representative of the value corresponding to adjacent portion of the vasculature” (emphasis herein added) , and Para. [0120], “In step 2490, if an appropriate user input has been selected, the processing system 106 provides guidance to the clinician regarding movements of the intravascular imaging probe controls 104 that may be required to advance or retract the probe 102 to a desired location within the patient's body, or to mark the start or end of a given vascular segment, or to start or stop recording. Such guidance may be determined through conventional techniques (e.g., database lookup) or through learning-based techniques” (emphasis herein added));
starting from the location of the blockage, search proximally and distally along the length of the blood vessel to determine proximal healthy tissue and distal healthy tissue, wherein the proximal healthy tissue corresponds to a first location proximal to the location of the blockage at which a first plaque burden of the plurality of plaque burdens is below a plaque burden threshold, wherein the distal healthy tissue corresponds to a second location distal to the location of the blockage at which a second plaque burden of the plurality of plaque burdens is below the plaque burden threshold, and wherein a distance between the proximal healthy tissue and the distal healthy tissue defines a length measurement (see, e.g., Para. [0083], “In this example, a reference value 746 and compression value 748 associated with the CIV segment 540 are automatically provided on the screen display […] the compression value is automatically calculated based on the obtained IVUS data and then output to the screen display adjacent to the virtual venogram 500. In this example, the CIV segment 540 is colored based on the comparison between the reference value and the compression value. For example, comparison can be a ratio of the compression value 748 and the reference value 746 (e.g., compression value divided by reference value). In this example, the CIV segment 540 is colored differently than the IVC segment 540. For example, when the compression value 748 is less than 50% of the reference value 746, the segment can be colored in a second color (e.g., green) to indicate that the amount of compression is potentially harmful to the patient. Different colorings, shadings, highlighting can be used for the comparison of the reference value 746 and compression value 748 (e.g., different colors for greater than 50%, less than 50%, between 0% and 25%, between 25 and 50%, between 50% and 75%, between 75% and 100%)”, and Para. [0084-0088], and Para. [0092-0094], and Para. [0095], “… labels 1310 (e.g., vasculature segment abbreviation, target frame, reference frame, frame representative of diseased or compressed vasculature, frame representative of vasculature that needs treatment, frame representative of healthy vasculature, etc.) The processing system 106 performs automatic image analysis of the obtained IVUS image data and calculates one or more metrics (e.g., cross-sectional lumen area, diameter, compression, plaque burden, etc.) A graphical representation 1320 of the automatically calculated metrics is shown on the roadmap image of the vasculature, e.g., adjacent to the vasculature. For example, the graphical representation can be a bar (such as in a bar graph) or a histogram representative of the value corresponding to adjacent portion of the vasculature. In some embodiments, two or more metrics can be displayed (e.g., in different colors)” (emphasis herein added), and Fig. 13, where the claimed first plaque burden that is displayed corresponds to the disclosed graphical representation 1320 that is positioned at the distal end of the body lumen segment, which is positioned toward the label 1310 titled “EIV REF” as shown in Fig. 13, and where the claimed second plaque burden that is displayed corresponds to the disclosed graphical representation 1320 that is positioned at the proximal end of the body lumen segment, which is positioned toward the label 1310 titled “CIV” as shown in Fig. 13, and Para. [0120], “In step 2490, if an appropriate user input has been selected, the processing system 106 provides guidance to the clinician regarding movements of the intravascular imaging probe controls 104 that may be required to advance or retract the probe 102 to a desired location within the patient's body, or to mark the start or end of a given vascular segment” (emphasis herein added)); and
output, to a display (monitor 108) in communication with the processor circuit (106), a screen display (see, e.g., Abstract, “The processor is configured to […] output to a display a stylized figure of the body lumen including the plurality of segments, and an indicator identifying the segment in the stylized figure where the imaging catheter was located when the image was obtained”, and Para. [0047], “A stent may be placed within the vessel to treat these blockages or narrowings, and intraluminal imaging may be carried out to view the placement of the stent within the vessel”, and Para. [0053], “The intraluminal imaging system 100 may include an intraluminal device 102, a patient interface module (PIM) 104, a console or processing system 106, a monitor 108”, and Para. [0057], “The intraluminal device 102, PIM 104, monitor 108, and external imaging system 132 may be communicatively coupled directly or indirectly to the processing system 106”, and Para. [0062], “The processing system 106 outputs image data such that an image of the vessel or lumen 120, such as a cross-sectional IVUS image of the lumen 120, is displayed on the monitor 108”, and Para. [0066], “The monitor 108 may be a display device such as a computer monitor or other type of screen. The monitor 108 may be used to display selectable prompts, instructions, and visualizations of imaging data to a user. In some embodiments, the monitor 108 may be used to provide a procedure-specific workflow to a user to complete an intraluminal imaging procedure. This workflow may include performing a pre-stent plan to determine the state of a lumen and potential for a stent, as well as a post-stent inspection to determine the status of a stent that has been positioned in a lumen. The workflow may be presented to a user as any of the displays or visualizations shown in FIGS. 5-7”, and Para. [0095], “FIG. 13 illustrates a screen display during review of the IVUS images obtained”) comprising:
a longitudinal view of the blood vessel distinct from an image of the blood vessel (see, e.g., Para. [0010], “The system where the screen display further includes at least one of a longitudinal display of the body lumen”, and Para. [0075], “a graphical representation of the peripheral vasculature (e.g., inferior vena cava, abdominal vena cava, renal veins, left and right common iliac veins, left and right common femoral veins, etc.) in which the intraluminal ultrasound device (e.g., IVUS catheter) is positioned. The graphical representations can be an illustration or cartoon of the vasculature (e.g., a virtual or non-medical image venogram) and/or an x-ray/CT/MRI image. For example, the graphical representation can be a roadmap image. The graphical representations can be formed from the obtained IVUS images. The graphical representations illustrate the longitudinal extent of the vasculature and can be referenced as a longitudinal display or image longitudinal display (ILD)”, and Para. [0095], “FIG. 13 illustrates a screen display during review of the IVUS images obtained during the pullback. The roadmap, longitudinal image, or virtual venogram 500 of the vasculature shows all of the bookmarked frames”);
an indicator for the proximal healthy tissue overlaid on the longitudinal view at the first location (see, e.g., Para. [0041], “This system, hereinafter referred to as an IVUS pullback virtual venogram system, helps make the correlation between IVUS frames and anatomy easier to understand, and provides positional navigation information by identifying and visually highlighting the segments in an artery or vessel that need attention”, and Para. [0074], “The screen displays perform several functions, including highlighting the segments of the vasculature, labeling the segments, and color coding or otherwise highlighting/distinguishing the segments and/or neighboring anatomy”, and Para. [0120], “In step 2490, if an appropriate user input has been selected, the processing system 106 provides guidance to the clinician regarding movements of the intravascular imaging probe controls 104 that may be required to advance or retract the probe 102 to a desired location within the patient's body, or to mark the start or end of a given vascular segment, or to start or stop recording. Such guidance may be determined through conventional techniques (e.g., database lookup) or through learning-based techniques” (emphasis added));
an indicator for the distal healthy tissue overlaid on the longitudinal view at the second location (see, e.g., Para. [0041], “This system, hereinafter referred to as an IVUS pullback virtual venogram system, helps make the correlation between IVUS frames and anatomy easier to understand, and provides positional navigation information by identifying and visually highlighting the segments in an artery or vessel that need attention”, and Para. [0074], “The screen displays perform several functions, including highlighting the segments of the vasculature, labeling the segments, and color coding or otherwise highlighting/distinguishing the segments and/or neighboring anatomy”, and Para. [0120], “In step 2490, if an appropriate user input has been selected, the processing system 106 provides guidance to the clinician regarding movements of the intravascular imaging probe controls 104 that may be required to advance or retract the probe 102 to a desired location within the patient's body, or to mark the start or end of a given vascular segment, or to start or stop recording. Such guidance may be determined through conventional techniques (e.g., database lookup) or through learning-based techniques” (emphasis added)); and
a region overlaid on the longitudinal view and visually distinguished from a remainder of the longitudinal view, wherein the region extends between the indicator for the proximal healthy tissue and the indicator for the distal healthy tissue, wherein the region is representative of the length measurement (see, e.g., Para. [0041], “This system, hereinafter referred to as an IVUS pullback virtual venogram system, helps make the correlation between IVUS frames and anatomy easier to understand, and provides positional navigation information by identifying and visually highlighting the segments in an artery or vessel that need attention”, and Para. [0066], “the monitor 108 may be used to provide a procedure-specific workflow to a user to complete an intraluminal imaging procedure. This workflow may include performing a pre-stent plan to determine the state of a lumen and potential for a stent, as well as a post-stent inspection to determine the status of a stent that has been positioned in a lumen. The workflow may be presented to a user as any of the displays or visualizations shown in FIGS. 5-7”, and Para. [0074], “The screen displays perform several functions, including highlighting the segments of the vasculature, labeling the segments, and color coding or otherwise highlighting/distinguishing the segments and/or neighboring anatomy”).
Regarding claim 2, Chao discloses the system of claim 1, as set forth above. Chao further discloses wherein the screen display further comprises the image of the blood vessel (see, e.g., Para. [0062], “The processing system 106 outputs image data such that an image of the vessel or lumen 120, such as a cross-sectional IVUS image of the lumen 120, is displayed on the monitor 108”, and Para. [0093], “A virtual venogram 500, acting as a roadmap in the live view 1100, automatically shows where the transducer array 124 is located within the body. […] The screen display 1100 also includes a live tomographic IVUS image 1010”, and Para. [0095], “FIG. 13 illustrates a screen display during review of the IVUS images obtained during the pullback. The roadmap, longitudinal image, or virtual venogram 500 of the vasculature shows all of the bookmarked frames […] The tomographic IVUS image 1010 can be automatically assigned a label 1240 using image analysis with the label presets (e.g., vasculature segment name, reference frame, target frame, etc.). The tomographic IVUS image frame 1010 can also include a visual representation 1340 of one or more calculated metrics for that image frame (e.g., numerical values of cross-sectional lumen area, diameter)”, and Fig. 13).
Regarding claim 19, Chao discloses the system of claim 1, as set forth above. Chao further discloses wherein the screen display further comprises a plaque burden graphic (graphical representations 1320, 1330) based on the plurality of plaque burdens and displayed simultaneously as the longitudinal view of the blood vessel (see, e.g., Para. [0095], “FIG. 13 illustrates a screen display during review of the IVUS images obtained during the pullback. The roadmap, longitudinal image, or virtual venogram 500 of the vasculature shows all of the bookmarked frames and labels 1310 (e.g., vasculature segment abbreviation, target frame, reference frame, frame representative of diseased or compressed vasculature, frame representative of vasculature that needs treatment, frame representative of healthy vasculature, etc.) The processing system 106 performs automatic image analysis of the obtained IVUS image data and calculates one or more metrics (e.g., cross-sectional lumen area, diameter, compression, plaque burden, etc.) A graphical representation 1320 of the automatically calculated metrics is shown on the roadmap image of the vasculature, e.g., adjacent to the vasculature. For example, the graphical representation can be a bar (such as in a bar graph) or a histogram representative of the value corresponding to adjacent portion of the vasculature. In some embodiments, two or more metrics can be displayed (e.g., in different colors). An alternative view 1330 of the graphical representation of the one or more metrics is also shown. For example, the graphical representation extends length-wise along the screen display, rather than adjacent to the vasculature in the roadmap image. Any suitable graphical representation, such as a line graph, a bar graph, symbols can be used to represent the metrics 1320 on the roadmap image or the alternative view of the metrics 1330”, and Fig. 13, where the claimed plaque burden graphic that is displayed corresponds to the disclosed graphical representations 1320 and/or 1330 of the automatically calculated metrics, such as plaque burden metrics).
Regarding claim 3, Chao discloses the system of claim 19, as set forth above. Chao further discloses wherein the plaque burden graphic (graphical representations 1320, 1330) is representative of only a subset of the plurality of intravascular images, the subset comprising intravascular images of locations within the region (see, e.g., Fig. 13, and Para. [0095], “FIG. 13 illustrates a screen display during review of the IVUS images obtained during the pullback. The roadmap, longitudinal image, or virtual venogram 500 of the vasculature shows all of the bookmarked frames and labels 1310 (e.g., vasculature segment abbreviation, target frame, reference frame, frame representative of diseased or compressed vasculature, frame representative of vasculature that needs treatment, frame representative of healthy vasculature, etc.) The processing system 106 performs automatic image analysis of the obtained IVUS image data and calculates one or more metrics (e.g., cross-sectional lumen area, diameter, compression, plaque burden, etc.) A graphical representation 1320 of the automatically calculated metrics is shown on the roadmap image of the vasculature, e.g., adjacent to the vasculature. For example, the graphical representation can be a bar (such as in a bar graph) or a histogram representative of the value corresponding to adjacent portion of the vasculature. In some embodiments, two or more metrics can be displayed (e.g., in different colors). An alternative view 1330 of the graphical representation of the one or more metrics is also shown. For example, the graphical representation extends length-wise along the screen display, rather than adjacent to the vasculature in the roadmap image. Any suitable graphical representation, such as a line graph, a bar graph, symbols can be used to represent the metrics 1320 on the roadmap image or the alternative view of the metrics 1330”).
Regarding claims 4, Chao discloses the system of claim 19, as set forth above. Chao further discloses wherein the plaque burden graphic (graphical representations 1320, 1330) includes one or more segments, wherein each segment of the one or more segments corresponds to one or more intravascular images of the plurality of intravascular images (see, e.g., Para. [0095], where there can be one or more of the disclosed calculated metrics 1320, 1330 for the respective image frame, and Fig. 13, where the disclosed calculated metrics 1320, 1330 are shown to comprise multiple segments/lines/sections/regions).
Regarding claims 5, Chao discloses the systems of claim 4, as set forth above. Chao further discloses wherein each segment includes one or more regions, wherein a visual appearance of the one or more regions corresponds to a cross-sectional area of the blood vessel or a cross-sectional area of plaque (see, e.g., Para. [0095], where there can be one or more of the disclosed calculated metrics 1320, 1330 for the respective image frame, and Fig. 13, where the disclosed calculated metrics 1320, 1330 are shown to comprise multiple segments/lines/sections/regions that each shown to correspond visually and be positioned/aligned to a respective area of the region of interest on the screen display).
Regarding claim 6, Chao discloses the system of claim 3, as set forth above. Chao further discloses wherein the plaque burden graphic (graphical representations 1320, 1330) is positioned within the screen display such that the plaque burden graphic (1320, 1330) is longitudinally aligned with the region in the longitudinal view (see, e.g., Para. [0095], and Fig. 13, where the disclosed calculated metrics 1320, 1330 are each shown to be positioned/aligned with the respective region of interest on the screen display).
Regarding claim 10, Chao discloses the system of claim 2, as set forth above. Chao further discloses wherein the processor circuit (processing system 106) is further configured for communication with an extraluminal imaging device (external imaging system 132) configured to obtain an extraluminal image (see, e.g., Para. [0053], “FIG. 1 is a diagrammatic schematic view of an intraluminal imaging system incorporating the IVUS pullback virtual venogram system, according to aspects of the present disclosure. The intraluminal imaging system 100 can be an intravascular ultrasound (IVUS) imaging system in some embodiments. The intraluminal imaging system 100 may include an intraluminal device 102, a patient interface module (PIM) 104, a console or processing system 106, a monitor 108, and an external imaging system 132 which may include angiography, ultrasound, X-ray, computed tomography (CT), magnetic resonance imaging (MRI), or other imaging technologies, equipment, and methods”, and Para. [0057], “The intraluminal device 102, PIM 104, monitor 108, and external imaging system 132 may be communicatively coupled directly or indirectly to the processing system 106”, and Para. [0067]), and wherein the image of the blood vessel comprises the extraluminal image (see, e.g., Para. [0067], and Para. [0075], “a graphical representation of the peripheral vasculature (e.g., inferior vena cava, abdominal vena cava, renal veins, left and right common iliac veins, left and right common femoral veins, etc.) in which the intraluminal ultrasound device (e.g., IVUS catheter) is positioned. The graphical representations can be an illustration or cartoon of the vasculature (e.g., a virtual or non-medical image venogram) and/or an x-ray/CT/MRI image. For example, the graphical representation can be a roadmap image”).
Regarding claim 11, Chao discloses the system of claim 10, as set forth above. Chao further discloses wherein the processor circuit (processing system 106) is further configured to coregister the plurality of intravascular images and the plurality of plaque burdens to corresponding positions within the extraluminal image (see, e.g., Para. [0044], “The present disclosure substantially aids a clinician in orienting, navigating, and guiding an intravascular imaging probe or intraluminal imaging probe within a vessel or lumen of a patient, by providing a venogram-type roadmap during intraluminal medical imaging procedures. The venogram-type roadmap may include stylized, statistically representative human anatomy, along with directionality indicators, automatic measurement tools, step by step navigation or operating instructions, and co-registered vessel maps showing the position of the probe within a patient's anatomy”, and Para. [0091], “The screen displays provide: auto-label based on anatomical landmark information (e.g., arterial branching), auto-label based on image analysis, bookmark thumbnails on the side, roadmap view (e.g., virtual venogram or actual venogram, the latter of which may be co-registered with tomographic image data)”, and Para. [0093], “A virtual venogram 500, acting as a roadmap in the live view 1100, automatically shows where the transducer array 124 is located within the body. In some embodiments, a co-registered X-ray, CAT scan, or fluoroscopy image may be used as a roadmap instead of or in addition to the virtual venogram 500”, and Para. [0095], “FIG. 13 illustrates a screen display during review of the IVUS images obtained during the pullback. The roadmap, longitudinal image, or virtual venogram 500 of the vasculature shows all of the bookmarked frames and labels 1310 (e.g., vasculature segment abbreviation, target frame, reference frame, frame representative of diseased or compressed vasculature, frame representative of vasculature that needs treatment, frame representative of healthy vasculature, etc.) The processing system 106 performs automatic image analysis of the obtained IVUS image data and calculates one or more metrics (e.g., cross-sectional lumen area, diameter, compression, plaque burden, etc.) A graphical representation 1320 of the automatically calculated metrics is shown on the roadmap image of the vasculature, e.g., adjacent to the vasculature”).
Regarding claim 12, Chao discloses the system of claim 19, as set forth above. Chao further discloses wherein the plaque burden graphic (graphical representations 1320, 1330) is specific to the region such that a length of the plaque burden graphic (1320, 1330) is shorter than a length of the longitudinal view of the blood vessel (see, e.g., Fig. 13, and Para. [0095], “FIG. 13 illustrates a screen display during review of the IVUS images obtained during the pullback. The roadmap, longitudinal image, or virtual venogram 500 of the vasculature shows all of the bookmarked frames and labels 1310 (e.g., vasculature segment abbreviation, target frame, reference frame, frame representative of diseased or compressed vasculature, frame representative of vasculature that needs treatment, frame representative of healthy vasculature, etc.) The processing system 106 performs automatic image analysis of the obtained IVUS image data and calculates one or more metrics (e.g., cross-sectional lumen area, diameter, compression, plaque burden, etc.) A graphical representation 1320 of the automatically calculated metrics is shown on the roadmap image of the vasculature, e.g., adjacent to the vasculature. For example, the graphical representation can be a bar (such as in a bar graph) or a histogram representative of the value corresponding to adjacent portion of the vasculature. In some embodiments, two or more metrics can be displayed (e.g., in different colors). An alternative view 1330 of the graphical representation of the one or more metrics is also shown. For example, the graphical representation extends length-wise along the screen display, rather than adjacent to the vasculature in the roadmap image. Any suitable graphical representation, such as a line graph, a bar graph, symbols can be used to represent the metrics 1320 on the roadmap image or the alternative view of the metrics 1330”).
Regarding claim 21, Chao discloses the system of claim 1, as set forth above. Chao further discloses wherein the region corresponds to the location of the blockage (see, e.g., Para. [0041], “This system, hereinafter referred to as an IVUS pullback virtual venogram system, helps make the correlation between IVUS frames and anatomy easier to understand, and provides positional navigation information by identifying and visually highlighting the segments in an artery or vessel that need attention”, and Para. [0066], “the monitor 108 may be used to provide a procedure-specific workflow to a user to complete an intraluminal imaging procedure. This workflow may include performing a pre-stent plan to determine the state of a lumen and potential for a stent, as well as a post-stent inspection to determine the status of a stent that has been positioned in a lumen. The workflow may be presented to a user as any of the displays or visualizations shown in FIGS. 5-7”, and Para. [0074], “The screen displays perform several functions, including highlighting the segments of the vasculature, labeling the segments, and color coding or otherwise highlighting/distinguishing the segments and/or neighboring anatomy”, and Para. [0120], “In step 2490, if an appropriate user input has been selected, the processing system 106 provides guidance to the clinician regarding movements of the intravascular imaging probe controls 104 that may be required to advance or retract the probe 102 to a desired location within the patient's body, or to mark the start or end of a given vascular segment, or to start or stop recording. Such guidance may be determined through conventional techniques (e.g., database lookup) or through learning-based techniques” (emphasis added)).
Regarding claim 22, Chao discloses the system of claim 1, as set forth above. Chao further discloses wherein the screen display is configured for a user to plan a proposed treatment for the blockage (see, e.g., Para. [0041], “This system, hereinafter referred to as an IVUS pullback virtual venogram system, helps make the correlation between IVUS frames and anatomy easier to understand, and provides positional navigation information by identifying and visually highlighting the segments in an artery or vessel that need attention”, and Para. [0066], “the monitor 108 may be used to provide a procedure-specific workflow to a user to complete an intraluminal imaging procedure. This workflow may include performing a pre-stent plan to determine the state of a lumen and potential for a stent, as well as a post-stent inspection to determine the status of a stent that has been positioned in a lumen. The workflow may be presented to a user as any of the displays or visualizations shown in FIGS. 5-7”).
Regarding claim 23, Chao discloses the system of claim 22, as set forth above. Chao further discloses wherein the proposed treatment comprises a proposed stent, wherein the proximal healthy tissue corresponds to a proximal landing zone for the proposed stent and the distal healthy tissue corresponds to a distal landing zone for the proposed stent (see, e.g., Para. [0066], “the monitor 108 may be used to provide a procedure-specific workflow to a user to complete an intraluminal imaging procedure. This workflow may include performing a pre-stent plan to determine the state of a lumen and potential for a stent, as well as a post-stent inspection to determine the status of a stent that has been positioned in a lumen. The workflow may be presented to a user as any of the displays or visualizations shown in FIGS. 5-7”, and Para. [0074], “The screen displays perform several functions, including highlighting the segments of the vasculature, labeling the segments, and color coding or otherwise highlighting/distinguishing the segments and/or neighboring anatomy”, and Para. [0120], “In step 2490, if an appropriate user input has been selected, the processing system 106 provides guidance to the clinician regarding movements of the intravascular imaging probe controls 104 that may be required to advance or retract the probe 102 to a desired location within the patient's body, or to mark the start or end of a given vascular segment, or to start or stop recording. Such guidance may be determined through conventional techniques (e.g., database lookup) or through learning-based techniques” (emphasis added)).
Regarding claim 24, Chao discloses the system of claim 23, as set forth above. Chao further discloses wherein the length measurement corresponds to a length for the proposed stent (see, e.g., Para. [0066], “the monitor 108 may be used to provide a procedure-specific workflow to a user to complete an intraluminal imaging procedure. This workflow may include performing a pre-stent plan to determine the state of a lumen and potential for a stent, as well as a post-stent inspection to determine the status of a stent that has been positioned in a lumen. The workflow may be presented to a user as any of the displays or visualizations shown in FIGS. 5-7”, and Para. [0074], “The screen displays perform several functions, including highlighting the segments of the vasculature, labeling the segments, and color coding or otherwise highlighting/distinguishing the segments and/or neighboring anatomy”, and Para. [0120], “In step 2490, if an appropriate user input has been selected, the processing system 106 provides guidance to the clinician regarding movements of the intravascular imaging probe controls 104 that may be required to advance or retract the probe 102 to a desired location within the patient's body, or to mark the start or end of a given vascular segment, or to start or stop recording. Such guidance may be determined through conventional techniques (e.g., database lookup) or through learning-based techniques” (emphasis added)).
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 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chao (US 2020/0129142 A1), as applied to claim 1 above, in view of Merritt et al. (US 2019/0282211 A1, of record, cited in the applicant’s IDS filed on 04/18/2023, hereinafter Merritt).
Regarding claim 18, Chao discloses the system of claim 1, as set forth above. Chao does not specifically disclose wherein the screen display further comprises: a numerical value of the first plaque burden; and a numerical value of the second plaque burden, wherein the numerical value of the first plaque burden and the numerical value of the second plaque burden are displayed simultaneously as the longitudinal view of the blood vessel.
However, in the same field of endeavor of medical intraluminal ultrasound imaging, Merritt discloses wherein the screen display further comprises: a numerical value of the first plaque burden; and a numerical value of the second plaque burden, wherein the numerical value of the first plaque burden and the numerical value of the second plaque burden are displayed simultaneously as the longitudinal view of the blood vessel (see, e.g., Fig. 7, and Para. [0056], “FIG. 7 shows an exemplary visualization 700 showing a lesion view according to aspects of the present disclosure. […] the visualization 700 may be used to visualize a portion of a lumen 120 with a potential “landing zone” 834 for a stent. In some embodiments, the landing zone 834 is an area of interest within the lumen 120 that includes an MLA of a portion of the lumen 120, as marked by marker 614. The landing zone 834 may be shown in profile in view 610 to show the potential placement of the stent within the landing zone 834. A distal end marker 830 and a proximal end marker 832 of the landing zone 834 may define the distal and proximal extent of a potential stent. The distal end marker 830 and proximal end marker 832 may be accompanied with numerical data 820, 822 illustrating the average diameter and plaque burden of the lumen 120 at these locations. In some embodiments, the visualization may also a depiction of the plaque burden 852 along the lumen 120. In some embodiments, the depiction of the plaque burden 852 is automatically measured based on imaging data from the device 102. The visualization 700 may also include a depiction of lumen area 850. As illustrated in FIG. 7, the marker 614 for the MLA may be placed where the plaque burden is the greatest and the area of the lumen is the smallest. One or more of a plaque burden measurement, a lumen diameter measurement, a lumen area measurement, and other image- or physiology-based measurements may be used to generate a lesion score”).
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 system of Chao by including wherein the screen display further comprises: a numerical value of the first plaque burden; and a numerical value of the second plaque burden, wherein the numerical value of the first plaque burden and the numerical value of the second plaque burden are displayed simultaneously as the longitudinal view of the blood vessel, as disclosed by Merritt. One of ordinary skill in the art would have been motivated to make this modification in order to aid in assessing diseased vessels within the human body to determine the need for treatment, to optimize treatment, and/or to assess its effectiveness, and in order to desirably view different sets of imaging data, as recognized by Merritt (see, e.g., Para. [0002] and [0065]).
Regarding claim 9, Chao modified by Merritt discloses the system of claim 18, as set forth above. Chao further discloses wherein the processor circuit (processing system 106) is further configured to: receive, by an input device, a user input (see, e.g., Para. [0063], “The controller or processing system 106 may include a processing circuit having one or more processors in communication with memory and/or other suitable tangible computer readable storage media. […] For example, the system 100 can include a touch screen device, including a housing having a touch screen display and a processor. The system 100 can include any suitable input device, such as a touch sensitive pad or touch screen display, keyboard/mouse, joystick, button, etc., for a user to select options shown on the monitor 108. The processing system 106, the monitor 108, the input device, and/or combinations thereof can be referenced as a controller of the system 100. The controller can be in communication with the device 102, the PIM 104, the processing system 106, the monitor 108, the input device, and/or other components of the system 100”).
Chao does not specifically disclose wherein the processor circuit is further configured to: receive, by an input device, a user input specifically moving at least one of the indicator for the proximal healthy tissue or the indicator for the distal healthy tissue to a different location; and in response to the user input, update at least one of the numerical value of the first plaque burden or the numerical value of the second plaque burden based on the different location.
However, in the same field of endeavor of medical intraluminal ultrasound imaging, Merritt discloses wherein the processor circuit is further configured to: receive, by an input device, a user input moving at least one of the indicator for the proximal healthy tissue or the indicator for the distal healthy tissue to a different location; and in response to the user input, update at least one of the numerical value of the first plaque burden or the numerical value of the second plaque burden based on the different location (see, e.g., Figs. 7 and 10-11, and Para. [0056], “A distal end marker 830 and a proximal end marker 832 of the landing zone 834 may define the distal and proximal extent of a potential stent. The distal end marker 830 and proximal end marker 832 may be accompanied with numerical data 820, 822 illustrating the average diameter and plaque burden of the lumen 120 at these locations. In some embodiments, the visualization may also a depiction of the plaque burden 852 along the lumen 120. In some embodiments, the depiction of the plaque burden 852 is automatically measured based on imaging data from the device 102. The visualization 700 may also include a depiction of lumen area 850. As illustrated in FIG. 7, the marker 614 for the MLA may be placed where the plaque burden is the greatest and the area of the lumen is the smallest. One or more of a plaque burden measurement, a lumen diameter measurement, a lumen area measurement, and other image- or physiology-based measurements may be used to generate a lesion score”, and Para. [0061], and Para. [0065], “The visualization 1100 may include indicators 1114, 1118 marking the distal and proximal edges of the stent based on the received imaging data, as well as indicators 1112, 1120 marking distal and proximal reference points. […] the distal and proximal references are determined by the user. The indicators 1112, 1120 may be moved along the lumen by the user to view different sets of imaging data. The visualization 1100 may also include an indicator 1116 marking the MSA of the stent. The transverse view 1122 may correspond to this indicator as shown in FIG. 11. The user may also be able to select any of the other indicators 1112, 1114, 1118, 1120 to access a transverse view with data corresponding to the position of the selected indicator 1112, 1114, 1118, 1120 in the vessel”, where the disclosed distal and proximal references are determined by the user, and where the indicators 1112, 1120 may be moved/updated along the lumen by the user to view different sets of imaging 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 further modified the system of Chao modified by Merritt by including wherein the processor circuit is further configured to: receive, by an input device, a user input specifically moving at least one of the indicator for the proximal healthy tissue or the indicator for the distal healthy tissue to a different location; and in response to the user input, update at least one of the numerical value of the first plaque burden or the numerical value of the second plaque burden based on the different location, as disclosed by Merritt. One of ordinary skill in the art would have been motivated to make this modification in order to aid in assessing diseased vessels within the human body to determine the need for treatment, to optimize treatment, and/or to assess its effectiveness, and in order to desirably view different sets of imaging data, as recognized by Merritt (see, e.g., Para. [0002] and [0065]).
Response to Arguments
Applicant's arguments, see Remarks filed 04/29/2026, have been fully considered but they are not persuasive.
Regarding Chao (US 2020/0129142 A1), Applicant argues that Chao does not disclose or suggest searching proximally and distally from the blockage's location to determine proximal and distal healthy tissue.
Examiner respectfully disagrees and emphasizes that Chao does disclose each and every feature of amended independent claims 1 and 16, as set forth above. Specifically, Examiner emphasizes that Chao discloses: starting from the location of the blockage, search proximally and distally along the length of the blood vessel to determine proximal healthy tissue and distal healthy tissue, wherein the proximal healthy tissue corresponds to a first location proximal to the location of the blockage at which a first plaque burden of the plurality of plaque burdens is below a plaque burden threshold, wherein the distal healthy tissue corresponds to a second location distal to the location of the blockage at which a second plaque burden of the plurality of plaque burdens is below the plaque burden threshold, and wherein a distance between the proximal healthy tissue and the distal healthy tissue defines a length measurement (see, e.g., Para. [0083], “In this example, a reference value 746 and compression value 748 associated with the CIV segment 540 are automatically provided on the screen display […] the compression value is automatically calculated based on the obtained IVUS data and then output to the screen display adjacent to the virtual venogram 500. In this example, the CIV segment 540 is colored based on the comparison between the reference value and the compression value. For example, comparison can be a ratio of the compression value 748 and the reference value 746 (e.g., compression value divided by reference value). In this example, the CIV segment 540 is colored differently than the IVC segment 540. For example, when the compression value 748 is less than 50% of the reference value 746, the segment can be colored in a second color (e.g., green) to indicate that the amount of compression is potentially harmful to the patient. Different colorings, shadings, highlighting can be used for the comparison of the reference value 746 and compression value 748 (e.g., different colors for greater than 50%, less than 50%, between 0% and 25%, between 25 and 50%, between 50% and 75%, between 75% and 100%)”, and Para. [0084-0088], and Para. [0092-0094], and Para. [0095], “… labels 1310 (e.g., vasculature segment abbreviation, target frame, reference frame, frame representative of diseased or compressed vasculature, frame representative of vasculature that needs treatment, frame representative of healthy vasculature, etc.) The processing system 106 performs automatic image analysis of the obtained IVUS image data and calculates one or more metrics (e.g., cross-sectional lumen area, diameter, compression, plaque burden, etc.) A graphical representation 1320 of the automatically calculated metrics is shown on the roadmap image of the vasculature, e.g., adjacent to the vasculature. For example, the graphical representation can be a bar (such as in a bar graph) or a histogram representative of the value corresponding to adjacent portion of the vasculature. In some embodiments, two or more metrics can be displayed (e.g., in different colors)” (emphasis herein added), and Fig. 13, where the claimed first plaque burden that is displayed corresponds to the disclosed graphical representation 1320 that is positioned at the distal end of the body lumen segment, which is positioned toward the label 1310 titled “EIV REF” as shown in Fig. 13, and where the claimed second plaque burden that is displayed corresponds to the disclosed graphical representation 1320 that is positioned at the proximal end of the body lumen segment, which is positioned toward the label 1310 titled “CIV” as shown in Fig. 13, and Para. [0120], “In step 2490, if an appropriate user input has been selected, the processing system 106 provides guidance to the clinician regarding movements of the intravascular imaging probe controls 104 that may be required to advance or retract the probe 102 to a desired location within the patient's body, or to mark the start or end of a given vascular segment” (emphasis herein added)).
Therefore, Chao does disclose each and every feature of amended independent claims 1 and 16, as set forth above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following prior art are each in the same field of endeavor of ultrasound imaging related to imaging a patient’s vasculature: Canfield et al. (US 2017/0124771 A1); Choi et al. (US 2021/0090249 A1); Gopinath (US 2018/0085170 A1); and Gopinath et al. (US 2016/0171711 A1).
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.
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/T.D./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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