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 .
Applicant' s arguments, filed 10/16/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 10/16/2025.
Claims 1-22 are the currently pending claims. Claims 20-22 have been previously withdrawn; and claims 1-19 are under examination.
Claim Rejections - 35 USC § 102
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.
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.
Claims 1-2, 5-10, 12-13 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Petroff et al. (US 20220061670 A1), hereto referred as Petroff.
Regarding claim 1, Petroff teaches that the method comprises: receiving, by one or more processors, a plurality of extravascular images of the vessel during a pullback of an intravascular imaging probe having a defined pullback length along a first region of the vessel (Petroff, [0253]: "System 10 can provide high resolution morphological images and other high-resolution morphological information, such as are produced using at least OCT data gathered by probe 100"; [0240]: "System 10 can add lengths, by turning the time-points of each snap-shot into distances. For example, for a zero-order: the pullback speed is used to convert to distance… a radiopaque marker of probe 100 can be identified at the start of pullback and at the end of the pullback, and an angiography image (frame) closest in time to the respective trigger… The distance traversed between the radiopaque marker at sequence (ii) and (iv) is the pullback distance (e.g. a distance of 50 mm). System 10 can map this known pullback distance along the artery shape, such as in a linear fashion", demonstrating that Petroff receives both extravascular images (angiography) and intravascular images (OCT) during a defined pullback length; where [0123] and [0125] discusses the processor used in the system); detecting, by the one or more processors, locations of one or more markers in the plurality of extravascular images (Petroff, [0113]: "Imaging probe 100 can comprise one or more visualizable markers along its length (e.g. along shaft 120), markers 131 a-b shown (marker 131 herein). Marker 131 can comprise markers selected from the group consisting of: radiopaque markers; ultrasonically reflective markers; magnetic markers; ferrous material; and combinations of one or more of these", [0115]: "In some embodiments, tip 119 can comprise a radiopaque marker configured to increase the visibility of imaging probe 100 under an X-ray or fluoroscope", [0240]: "...the radiopaque marker of probe 100 can be identified at the start of pullback and at the end of the pullback, and an angiography image (frame) closest in time to the respective trigger...", [0184]: "In some embodiments, the data can be registered using the location, size, and shape of one or more side branches of the selected artery", showing that Petroff uses both physical markers visible in extravascular images (e.g., radiopaque markers on the probe in angiography) and anatomical landmarks (side branches) seen in extravascular imaging as registration points for detection and localization; where [0123] and [0125] discusses the processor used in the system); correlating, by the one or more processors, the first region of the vessel represented in the plurality of extravascular images with the pullback length based on the location of the one or more markers in the plurality of extravascular images (Petroff, [0240]: "a radiopaque marker of probe 100 can be identified at the start of pullback and at the end of the pullback, and an angiography image (frame) closest in time to the respective trigger... The distance traversed between the radiopaque marker at sequence (ii) and (iv) is the pullback distance"; [0184]: "In Step 1313, OCT data and Non-OCT data (e.g. angiography data) can be registered (e.g. correlated)", showing that Petroff correlates the first region of the vessel in extravascular images with the pullback length using radiopaque markers); determining, by the one or more processors, a size of a second region of the vessel represented in the plurality of extravascular images based on the correlation of the first region of the vessel represented in the plurality of extravascular images with the pullback length (Petroff, [0222]: "Probe 100 and retraction assembly 800 can be configured to provide up to a 10 cm pullback, which can image from the vessel ostium to locations beyond the diseased areas for most coronary lesions (e.g. all lesions on the left side and for most of the lesions on the right side)" Petroff discusses that the system is capable of imaging not only a primary lesion region, but also additional proximal or distal vessel regions beyond the target area (These additional regions—whether distal, proximal, or otherwise situated—are each anticipated as possible 'second regions' depending on the specific clinical focus or context, and are not limited to a single location; [0232]: "angiography data can be analyzed to determine the extent of stenosis proximal and distal to the clear portion of the pullback. Subsequently, Rd is calculated for these areas outside of the delineated pullback" Petroff demonstrates that after correlating and imaging a primary region, the system determines the size and disease state of one or more additional regions beyond the intravascular pullback zone using extravascular images (These regions can vary in number and location—including both proximal and distal areas—and each qualifies as a 'second region' within the meaning of the claim; [0185]-[0187]: "In Step 1320, cardiovascular flow dynamics can be calculated based on the analyzed data (e.g. the OCT data and/or Non-OCT data collected and/or analyzed). In some embodiments, system 10 is configured to estimate microvascular resistance distal to the selected artery," Petroff shows that after correlating and analyzing the imaging data from the first region, the system uses that correlation as a basis to determine functional and size metrics for a region or regions outside the primary pullback; Thus, the 'second region' may encompasses any region(s) for which extravascular data is available beyond the intravascular imaging zone).
Regarding claim 2, Petroff teaches that the size of the second region of the vessel includes at least one of a length of the second region, a cross-section diameter within the second region, and a cross-sectional area within the second region (Petroff, [0232]: "angiography data can be analyzed to determine the extent of stenosis proximal and distal to the clear portion of the pullback. Subsequently, Rd is calculated for these areas outside of the delineated pullback", showing that the system determines the extent or length of disease in a second region (Petroff uses “extent of stenosis” in reference to vessel regions, and a person of ordinary skill in the art would understand this to include the length of affected vessel, not merely severity at a single point), as well as the resistance (Rd, [0217]) which uses a diameter (cross-section diameter) and by extension, cross-sectional area, in a region outside of the primary pullback zone).
Regarding claim 5, Petroff teaches that the second region of the vessel includes at least one of a distal epicardial region and a proximal epicardial region of the vessel (Petroff, [0232]: "If the tissue at the end portions is diseased, angiography data can be analyzed to determine the extent of stenosis proximal and distal to the clear portion of the pullback", Petroff confirms that after imaging and correlating a primary region, the system analyzes regions beyond (proximal and distal) to the main pullback zone using extravascular imaging; [0184]: "system 10 can comprise a digital model of the expected branching of one or more of the major vessels of the heart, for example the LCx, RCA, and/or LAD arteries", demonstrating that both OCT and angiography data are registered with respect to a digital model of the major epicardial arteries, thereby encompassing analysis of both distal and proximal epicardial regions).
Regarding claim 6, Petroff teaches that determining the size of a second region of the vessel includes determining a length of the distal epicardial region and a length of the proximal epicardial region (Petroff, [0232]: "If the tissue at the end portions is diseased, angiography data can be analyzed to determine the extent of stenosis proximal and distal to the clear portion of the pullback", Petroff explicitly discusses analysis of regions proximal and distal to the main imaging area, including determination of disease extent (where a person of ordinary skill in the art would understand this to include the length of affected vessel, not merely severity at a single point) in these epicardial segments, thus encompassing determination of both distal and proximal region lengths; and [0184] demonstrates the region of interest to be epicardial arteries).
Regarding claim 7, Petroff teaches that correlating the first region of the vessel represented in the plurality of extravascular images with the pullback length includes scaling a lumen size represented in at least one of the plurality of extravascular images (Petroff, [0240]: "The distance traversed between the radiopaque marker at sequence (ii) and (iv) is the pullback distance (e.g. a distance of 50 mm). System 10 can map this known pullback distance along the artery shape, such as in a linear fashion. If landmarks are detected in the OCT image at time tlm, system 10 can add further corrections, where the distance moved is tlm times the pullback speed", Petroff describes using both OCT (intravascular) images and angiography (extravascular) images: the pullback length is established by the OCT pullback and marker detection in the extravascular images, and then this length is mapped to the artery shape in the angiogram, scaling the lumen and vessel path in extravascular images in correspondence to the known pullback length; [0189]: "In some embodiments, the data is shown in an overlay arrangement (e.g. OCT data is overlaid on angiography data and/or other non-OCT data), such as after the multiple sets of data have been registered in Step 1320... Calculated vessel sizes are displayed along with the OCT images and/or non-OCT images (e.g. angiography images)", Petroff teaches overlaying registered OCT and angiography images and simultaneously displaying calculated vessel sizes from each modality. This necessarily requires that the system scale the lumen size in the extravascular (angiography) images to anatomically correspond with the OCT pullback length).
Regarding claim 8, Petroff teaches that the plurality of extravascular images are taken from a plurality of locations relative to the vessel (Petroff, [0127]: "Second imaging device 15 can comprise an imaging device such as one or more imaging devices selected from the group consisting of: an X-ray; a fluoroscope such as a single plane or biplane fluoroscope; a CT Scanner; an MRI; a PET Scanner; an ultrasound imager; and combinations of one or more of these. In some embodiments, second imaging device 15 comprises a device configured to perform rotational angiography", Petroff expressly discloses that extravascular images may be acquired using one or more different imaging modalities, including rotational acquisition for multiple spatial perspectives).
Regarding claim 9, Petroff teaches that the system analyzes the plurality of extravascular images so as to identify a three-dimensional orientation of one or more objects relative to the vessel (Petroff, [0127]: "Second imaging device 15 can comprise an imaging device such as one or more imaging devices... and combinations of one or more of these. In some embodiments, second imaging device 15 comprises a device configured to perform rotational angiography", Petroff expressly discloses that multiple extravascular imaging modalities, including rotational angiography, provide images from varying perspectives, implicitly supporting the identification of 3D orientation; [0191]: "System 10 can be configured to calculate the flow dynamics... using a full 3D Navier-Stokes simulation... numerous geometric and other features of the imaged area", Petroff confirms that images from different locations are used to reconstruct and determine 3D relationships of anatomical features and objects in the vessel; [0184]: "the data can be registered using the location, size, and shape of one or more side branches of the selected artery," Petroff teaches that the system identifies the three-dimensional position and orientation of vessel branches (objects) relative to the vessel, based on multiple extravascular images and registration).
Regarding claim 10, Petroff teaches that the one or more objects comprises a branch from the vessel and wherein the three-dimensional orientation of the branch includes a position and takeoff angle of the branch relative to the vessel (Petroff, [0180]: "System 10 can be configured to calculate (e.g. via algorithm 51) the branch angle of a side branch from the imaged artery. In some embodiments, the branch angle is used by algorithm 51 to calculate the side branch vessel diameter. System 10 can be configured to reconstruct at least a portion of the side branch from the OCT data (e.g. from the image slices of the OCT data), and/or from non-OCT data (e.g. from angiography data). In some embodiments, system 10 is configured to calculate the relationship between the side branch angle and the diameter of the size of the side branch (e.g. the size of the side branch relative to the size of the imaged artery)," Petroff expressly demonstrates that the system identifies both the position and takeoff angle (branch angle) of vessel branches relative to the main vessel, based on analysis of OCT and/or extravascular (angiography) images; [0184]: "the data can be registered using the location, size, and shape of one or more side branches of the selected artery," Petroff further confirms that the three-dimensional position and orientation of side branches (objects) relative to the vessel are determined through data registration).
Regarding claim 12, Petroff teaches that the system for identifying attributes of a vessel comprises: one or more memories for storing images of the vessel (Petroff, [0108]: "Imaging system 10 can further comprise multiple imaging devices, second imaging device 15 shown" Petroff shows that the system includes hardware for capturing and storing vessel images; [0123]: "Processor 52 can include one or more memory storage components, such as one or more memory circuits which store software routines, algorithms (e.g. algorithm 51), and other operating instructions of system 10, as well as data acquired by imaging probe 100, second imaging device 15, and/or another component of system 10", Petroff expressly states that the system includes one or more memory circuits for storing and processing images) and one or more processors (Petroff, [0125]: "Console 50 can further comprise a processing assembly, processor 52, configured to execute algorithm 51, and/or perform any type of data processing, such as digital signal processing", Petroff confirms that one or more processors are present for controlling, analyzing, and processing imaging data) configured to: capture a plurality of extravascular images of the vessel during a pullback of an intravascular imaging probe having a defined pullback length along a first region of the vessel (Petroff, [0127]: "Second imaging device 15 can comprise an imaging device such as one or more imaging devices selected from the group consisting of: an X-ray; a fluoroscope such as a single plane or biplane fluoroscope; a CT Scanner; an MRI; a PET Scanner; an ultrasound imager; and combinations of one or more of these", Petroff describes at least one extravascular imaging device used for capturing images; [0253]: "System 10 can provide high resolution morphological images and other high-resolution morphological information... based on OCT data and non-OCT data (e.g. at least angiography data)", Petroff confirms the simultaneous use of intravascular and extravascular imaging; [0240]: "System 10 can add lengths, by turning the time-points of each snap-shot into distances... the radiopaque marker of probe 100 can be identified at the start of pullback and at the end of the pullback... The distance traversed between the radiopaque marker at sequence (ii) and (iv) is the pullback distance (e.g. a distance of 50 mm). System 10 can map this known pullback distance along the artery shape, such as in a linear fashion", Petroff teaches capturing both extravascular images (angiography) and intravascular images (OCT) during a defined pullback length); detect locations of one or more markers in the plurality of extravascular images (Petroff, [0113]: "Imaging probe 100 can comprise one or more visualizable markers along its length (e.g. along shaft 120), markers 131 a-b shown (marker 131 herein). Marker 131 can comprise markers selected from the group consisting of: radiopaque markers; ultrasonically reflective markers; magnetic markers; ferrous material; and combinations of one or more of these", [0115]: "In some embodiments, tip 119 can comprise a radiopaque marker configured to increase the visibility of imaging probe 100 under an X-ray or fluoroscope", [0240]: "...the radiopaque marker of probe 100 can be identified at the start of pullback and at the end of the pullback, and an angiography image (frame) closest in time to the respective trigger...", [0184]: "In some embodiments, the data can be registered using the location, size, and shape of one or more side branches of the selected artery", showing that Petroff uses both physical markers visible in extravascular images (e.g., radiopaque markers on the probe in angiography) and anatomical landmarks (side branches) seen in extravascular imaging as registration points for detection and localization; where [0123] and [0125] discusses the processor used in the system); correlate the first region of the vessel represented in the plurality of extravascular images with the pullback length based on the location of the one or more markers in the plurality of extravascular images; (Petroff, [0240]: "a radiopaque marker of probe 100 can be identified at the start of pullback and at the end of the pullback, and an angiography image (frame) closest in time to the respective trigger... The distance traversed between the radiopaque marker at sequence (ii) and (iv) is the pullback distance"; [0184]: "In Step 1313, OCT data and Non-OCT data (e.g. angiography data) can be registered (e.g. correlated)", showing that Petroff correlates the first region of the vessel in extravascular images with the pullback length using radiopaque markers); determine a size of a second region of the vessel represented in the plurality of extravascular images based on the correlation of the first region of the vessel represented in the plurality of extravascular images with the pullback length (Petroff, [0222]: "Probe 100 and retraction assembly 800 can be configured to provide up to a 10 cm pullback, which can image from the vessel ostium to locations beyond the diseased areas for most coronary lesions (e.g. all lesions on the left side and for most of the lesions on the right side)" Petroff discusses that the system is capable of imaging not only a primary lesion region, but also additional proximal or distal vessel regions beyond the target area (These additional regions—whether distal, proximal, or otherwise situated—are each anticipated as possible 'second regions' depending on the specific clinical focus or context, and are not limited to a single location; [0232]: "angiography data can be analyzed to determine the extent of stenosis proximal and distal to the clear portion of the pullback. Subsequently, Rd is calculated for these areas outside of the delineated pullback" Petroff demonstrates that after correlating and imaging a primary region, the system determines the size and disease state of one or more additional regions beyond the intravascular pullback zone using extravascular images (These regions can vary in number and location—including both proximal and distal areas—and each qualifies as a 'second region' within the meaning of the claim; [0185]-[0187]: "In Step 1320, cardiovascular flow dynamics can be calculated based on the analyzed data (e.g. the OCT data and/or Non-OCT data collected and/or analyzed). In some embodiments, system 10 is configured to estimate microvascular resistance distal to the selected artery," Petroff shows that after correlating and analyzing the imaging data from the first region, the system uses that correlation as a basis to determine functional and size metrics for a region or regions outside the primary pullback; Thus, the 'second region' may encompasses any region(s) for which extravascular data is available beyond the intravascular imaging zone).
Regarding claim 13, Petroff teaches that the size of the second region of the vessel includes at least one of a length of the second region, a cross-section diameter within the second region, and a cross-sectional area within the second region (Petroff, [0232]: "angiography data can be analyzed to determine the extent of stenosis proximal and distal to the clear portion of the pullback. Subsequently, Rd is calculated for these areas outside of the delineated pullback" showing that the system determines the extent or length of disease in a second region (Petroff uses “extent of stenosis” in reference to vessel regions, and a person of ordinary skill in the art would understand this to include the length of affected vessel, not merely severity at a single point), as well as the resistance (Rd, [0217]) which uses a diameter (cross-section diameter) and by extension, cross-sectional area, in a region outside of the primary pullback zone).
Regarding claim 16, Petroff teaches that the second region of the vessel includes at least one of a distal epicardial region and a proximal epicardial region of the vessel (Petroff, [0232]: "If the tissue at the end portions is diseased, angiography data can be analyzed to determine the extent of stenosis proximal and distal to the clear portion of the pullback" Petroff confirms that after imaging and correlating a primary region, the system analyzes regions beyond (proximal and distal) to the main pullback zone using extravascular imaging; [0184]: "system 10 can comprise a digital model of the expected branching of one or more of the major vessels of the heart, for example the LCx, RCA, and/or LAD arteries" demonstrating that both OCT and angiography data are registered with respect to a digital model of the major epicardial arteries, thereby encompassing analysis of both distal and proximal epicardial regions).
Regarding claim 17, Petroff teaches that correlating the first region of the vessel represented in the plurality of extravascular images with the pullback length includes scaling a lumen size represented in at least one of the plurality of extravascular images (Petroff, [0240]: "The distance traversed between the radiopaque marker at sequence (ii) and (iv) is the pullback distance (e.g. a distance of 50 mm). System 10 can map this known pullback distance along the artery shape, such as in a linear fashion. If landmarks are detected in the OCT image at time tlm, system 10 can add further corrections, where the distance moved is tlm times the pullback speed" Petroff describes using both OCT (intravascular) images and angiography (extravascular) images: the pullback length is established by the OCT pullback and marker detection in the extravascular images, and then this length is mapped to the artery shape in the angiogram, scaling the lumen and vessel path in extravascular images in correspondence to the known pullback length; [0189]: "In some embodiments, the data is shown in an overlay arrangement (e.g. OCT data is overlaid on angiography data and/or other non-OCT data), such as after the multiple sets of data have been registered in Step 1320... Calculated vessel sizes are displayed along with the OCT images and/or non-OCT images (e.g. angiography images)" Petroff teaches overlaying registered OCT and angiography images and simultaneously displaying calculated vessel sizes from each modality. This necessarily requires that the system scale the lumen size in the extravascular (angiography) images to anatomically correspond with the OCT pullback length).
Regarding claim 18, Petroff teaches that the one or more objects comprises a branch from the vessel and wherein the three-dimensional orientation of the branch includes a position and takeoff angle of the branch relative to the vessel (Petroff, [0180]: "System 10 can be configured to calculate (e.g. via algorithm 51) the branch angle of a side branch from the imaged artery. In some embodiments, the branch angle is used by algorithm 51 to calculate the side branch vessel diameter. System 10 can be configured to reconstruct at least a portion of the side branch from the OCT data (e.g. from the image slices of the OCT data), and/or from non-OCT data (e.g. from angiography data). In some embodiments, system 10 is configured to calculate the relationship between the side branch angle and the diameter of the size of the side branch (e.g. the size of the side branch relative to the size of the imaged artery)," Petroff expressly demonstrates that the system identifies both the position and takeoff angle (branch angle) of vessel branches relative to the main vessel, based on analysis of OCT and/or extravascular (angiography) images [0184]: "the data can be registered using the location, size, and shape of one or more side branches of the selected artery," Petroff further confirms that the three-dimensional position and orientation of side branches (objects) relative to the vessel are determined through data registration).
Claim Rejections - 35 USC § 102/103
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.
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 3-4, 11, 14-15, and 19 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Petroff et al. (US 20220061670 A1), hereto referred as Petroff.
Petroff teaches claims 1 and 12 as described above.
Regarding claim 3, Petroff implicitly, inherently, or obviously teaches that the method further comprises computing, by the one or more processors, a virtual flow reserve (VFR) of the vessel based on a plurality of images captured by the intravascular imaging probe and based on the determined size of the second region of the vessel (Petroff, [0185]: "In Step 1320, cardiovascular flow dynamics can be calculated based on the analyzed data (e.g. the OCT data and/or Non-OCT data collected and/or analyzed). In some embodiments, system 10 is configured to estimate microvascular resistance distal to the selected artery", showing that system 10 (which operates via one or more processors, [0123] and [0125]) calculates flow reserve using as inputs the analyzed data—including measurements of size and attributes of additional vessel regions (the 'second region')—so that the calculation is performed based on the determined size of the second region; [0249]: "For example, system 10 can be configured to produce pre and post-treatment FFR data. In some embodiments, system 10 compares information produced based on image data (e.g. OCT data and/or non-OCT data) gathered prior to treatment, to information produced based on image data (e.g. OCT Data and/or non-OCT data) gathered after a treatment has been performed", Petroff discloses that the system’s processors generate FFR (VFR) by using analyzed image data from before and after an intervention, and this process is dependent on the characteristics—including size—of the second region, thereby satisfying the requirement that VFR is computed based on the determined size of the second region; [0253]: "In some embodiments, the high-resolution information produced by system 10 is based on OCT data and non-OCT data (e.g. at least angiography data)" Petroff confirms that the virtual flow reserve calculation performed by the processors utilizes both intra- and extravascular images, and incorporates the measured vessel characteristics of the second region as part of the computation). Although Petroff does not use the phrasing “based on the determined size of the second region,” a person of ordinary skill in the art would understand that computation of virtual flow reserve (FFR/VFR) necessarily requires the measured size (diameter, area, length) of the relevant vessel region as an input, since these attributes are fundamental to any hemodynamic calculation.
Regarding claim 4, Petroff implicitly, inherently, or obviously teaches that the VFR of the vessel is computed based on a distance between a vessel centerline and a boundary of the vessel within the second region of the vessel identified in at least one of the plurality of extravascular images (Petroff, [0232]: "If the tissue at the end portions is diseased, angiography data can be analyzed to determine the extent of stenosis proximal and distal to the clear portion of the pullback", Petroff demonstrates that a “second region”—meaning any area proximal or distal to the intravascular pullback zone—is identified and analyzed using extravascular imaging, with boundaries determined for VFR calculation; [0183]: "In some embodiments, non-OCT data is analyzed to identify one or more of the following: vessel geometries (e.g. curves, tapers, and/or trajectories)... vessel diameters...", Petroff teaches that extravascular images are analyzed to determine vessel boundaries and diameters, which, when paired with a vessel centerline, provide the data necessary for centerline-to-boundary measurements in the second region; [0185]: "In Step 1320, cardiovascular flow dynamics can be calculated based on the analyzed data (e.g. the OCT data and/or Non-OCT data collected and/or analyzed)", Petroff explicitly teaches using geometry from both OCT and extravascular imaging for flow reserve calculations, including in regions beyond the primary OCT pullback; [0194]: "System 10 can use the 3D coordinates of the centerline...to calculate cross-sectional images and/or reconstruct the vessel geometry in 3D space...", while this passage discusses centerline use for vessel reconstruction, Petroff does not explicitly state that this is applied to extravascular images; however, a person of ordinary skill in the art would understand that all vessel geometry analyses—including in extravascular images—necessarily use a centerline as a reference, and such centerline-to-boundary distances are standard in VFR computation). A person of ordinary skill in the art would recognize that Petroff’s method involves using extravascular imaging to determine vessel geometry—including the distance from centerline to boundary—in second regions (i.e., regions proximal or distal to the primary pullback), and that these values are required inputs for VFR calculation. All such steps are performed by system 10’s processor.
Regarding claim 11, Petroff implicitly, inherently, or obviously teaches that the one or more processors are further configured to compute a virtual flow reserve (VFR) of the vessel based on the identified position and takeoff angle of the branch (Petroff, [0180]: "...the branch angle is used by algorithm 51 to calculate the side branch vessel diameter... System 10 is configured to calculate the relationship between the side branch angle and the diameter...," Petroff shows the system analyzes position and angle of vessel branches and incorporates these values in anatomical modeling for flow calculation; [0184]: "...the data can be registered using the location, size, and shape of one or more side branches of the selected artery," Petroff confirms that branch features are included in the integrated model; [0191]: "System 10 can be configured to calculate the flow dynamics... using a full 3D Navier-Stokes simulation... numerous geometric and other features of the imaged area," Petroff shows that VFR/FFR computation is based on comprehensive 3D geometry, which includes branch position and angle). Although Petroff does not expressly state that VFR is computed solely from branch position and angle, the reference clearly teaches that anatomical features such as branch location and takeoff angle are measured and incorporated into the 3D anatomical vessel model, which is then used by the system’s processors to perform comprehensive flow reserve analysis using computational fluid dynamics (CFD). Because accurate CFD-based VFR/FFR calculations depend on complete vessel geometry—including the spatial relationships of all branches—one of ordinary skill in the art would understand that the contribution of branch position and angle is implicitly included in the flow reserve computation. This integration ensures that physiological models realistically represent the dynamics of blood flow in complex vascular networks, resulting in clinically meaningful and reliable VFR assessments.
Regarding claim 14, Petroff implicitly, inherently, or obviously teaches that the system is configured to compute a virtual flow reserve (VFR) of the vessel based on a plurality of images captured by the intravascular imaging probe and based on the determined size of the second region of the vessel (Petroff, [0185]: "In Step 1320, cardiovascular flow dynamics can be calculated based on the analyzed data (e.g. the OCT data and/or Non-OCT data collected and/or analyzed). In some embodiments, system 10 is configured to estimate microvascular resistance distal to the selected artery" showing that system 10 (which operates via one or more processors, [0123] and [0125]) calculates flow reserve using as inputs the analyzed data—including measurements of size and attributes of additional vessel regions (the 'second region')—so that the calculation is performed based on the determined size of the second region; [0249]: "For example, system 10 can be configured to produce pre and post-treatment FFR data. In some embodiments, system 10 compares information produced based on image data (e.g. OCT data and/or non-OCT data) gathered prior to treatment, to information produced based on image data (e.g. OCT Data and/or non-OCT data) gathered after a treatment has been performed" Petroff discloses that the system’s processors generate FFR (VFR) by using analyzed image data from before and after an intervention, and this process is dependent on the characteristics—including size—of the second region, thereby satisfying the requirement that VFR is computed based on the determined size of the second region; [0253]: "In some embodiments, the high-resolution information produced by system 10 is based on OCT data and non-OCT data (e.g. at least angiography data)" Petroff confirms that the virtual flow reserve calculation performed by the processors utilizes both intra- and extravascular images, and incorporates the measured vessel characteristics of the second region as part of the computation). Although Petroff does not use the phrasing “based on the determined size of the second region,” a person of ordinary skill in the art would understand that computation of virtual flow reserve (FFR/VFR) necessarily requires the measured size (diameter, area, length) of the relevant vessel region as an input, since these attributes are fundamental to any hemodynamic calculation.
Regarding claim 15, Petroff implicitly, inherently, or obviously teaches that the system is configured to compute the VFR of the vessel based on a distance between a vessel centerline and a boundary of the vessel within the second region of the vessel identified in at least one of the plurality of extravascular images (Petroff, [0232]: "If the tissue at the end portions is diseased, angiography data can be analyzed to determine the extent of stenosis proximal and distal to the clear portion of the pullback" Petroff demonstrates that a “second region”—meaning any area proximal or distal to the intravascular pullback zone—is identified and analyzed using extravascular imaging, with boundaries determined for VFR calculation; [0183]: "In some embodiments, non-OCT data is analyzed to identify one or more of the following: vessel geometries (e.g. curves, tapers, and/or trajectories)... vessel diameters..." Petroff teaches that extravascular images are analyzed to determine vessel boundaries and diameters, which, when paired with a vessel centerline, provide the data necessary for centerline-to-boundary measurements in the second region; (Petroff, [0185]: "In Step 1320, cardiovascular flow dynamics can be calculated based on the analyzed data (e.g. the OCT data and/or Non-OCT data collected and/or analyzed)" Petroff explicitly teaches using geometry from both OCT and extravascular imaging for flow reserve calculations, including in regions beyond the primary OCT pullback; (Petroff, [0194]: "System 10 can use the 3D coordinates of the centerline...to calculate cross-sectional images and/or reconstruct the vessel geometry in 3D space..." While this passage discusses centerline use for vessel reconstruction, Petroff does not explicitly state that this is applied to extravascular images; however, a person of ordinary skill in the art would understand that all vessel geometry analyses—including in extravascular images—necessarily use a centerline as a reference, and such centerline-to-boundary distances are standard in VFR computation). A person of ordinary skill in the art would recognize that Petroff’s system involves using extravascular imaging to determine vessel geometry—including the distance from centerline to boundary—in second regions (i.e., regions proximal or distal to the primary pullback), and that these values are required inputs for VFR calculation. All such steps are performed by system 10’s processor.
Regarding claim 19, Petroff implicitly, inherently, or obviously teaches that the one or more processors are further configured to compute a virtual flow reserve (VFR) of the vessel based on the identified position and takeoff angle of the branch (Petroff, [0180]: "...the branch angle is used by algorithm 51 to calculate the side branch vessel diameter... System 10 is configured to calculate the relationship between the side branch angle and the diameter...," Petroff shows the system analyzes position and angle of vessel branches and incorporates these values in anatomical modeling for flow calculation; [0184]: "...the data can be registered using the location, size, and shape of one or more side branches of the selected artery," Petroff confirms that branch features are included in the integrated model; [0191]: "System 10 can be configured to calculate the flow dynamics... using a full 3D Navier-Stokes simulation... numerous geometric and other features of the imaged area," Petroff shows that VFR/FFR computation is based on comprehensive 3D geometry, which includes branch position and angle). Although Petroff does not expressly state that VFR is computed solely from branch position and angle, the reference clearly teaches that anatomical features such as branch location and takeoff angle are measured and incorporated into the 3D anatomical vessel model, which is then used by the system’s processors to perform comprehensive flow reserve analysis using computational fluid dynamics (CFD). Because accurate CFD-based VFR/FFR calculations depend on complete vessel geometry—including the spatial relationships of all branches—one of ordinary skill in the art would understand that the contribution of branch position and angle is implicitly included in the flow reserve computation. This integration ensures that physiological models realistically represent the dynamics of blood flow in complex vascular networks, resulting in clinically meaningful and reliable VFR assessments.
Response to Arguments
Objections
Applicant's arguments filed 10/16/2025, page 6, regarding the previous Objections of claims 1, 6, 7, 12, and 17 have been fully considered and are persuasive. The previous Objections have been withdrawn.
35 U.S.C. §112(b)
Applicant's arguments filed 10/16/2025, page 6, regarding the previous 112(b) Rejections of claims 4 and 15 have been fully considered and are persuasive. The previous 112(b) rejections have been withdrawn.
35 U.S.C. §102
Applicant's arguments filed 10/16/2025, pages 6-7, regarding the previous 102 Rejections of claims 1-2, 5-10, 12-13 and 16-18 have been fully considered but are not persuasive. Specifically, Applicant argues that Petroff fails to disclose “determining a size of a second region of the vessel represented in extravascular images based on the correlation of the first region… with the pullback length,” asserting that Petroff merely generates separate OCT and non-OCT estimates and does not use the pullback correlation to determine size in a second region.
The argument is not persuasive. Petroff explicitly teaches that the algorithm converts pullback time data into spatial distance using angiographic and landmark co-registration; demonstrating that all subsequent geometric and flow measurements, including those in second regions outside the OCT segment, are derived from the same correlated pullback data. Once this correlation is established, Petroff’s system uses the registered angiography to evaluate and calculate vessel dimensions (e.g., stenosis extent, Rd) beyond the imaged area. The relevant disclosures are summarized below.
(A) Establishing correlation and distance conversion between OCT pullback and extravascular imaging.
“Algorithm 51 can convert time information to a distance using various techniques to reduce error. For example, high-speed pullbacks (e.g., at least 50 cm/sec), gated pullbacks, angiographic co-registration, landmark co-registration (e.g., side branch co-registration), and the like. Algorithm 51 can include side branch information in a model, such as in the form of additional resistive elements, and/or flow modifiers.” (Petroff, ¶[0237]).
“System 10 can add lengths, by turning the time-points of each snap-shot into distances… a gated pullback can be used, with semi or fully automated simplified co-registration (single plane angiographic image)… a radiopaque marker of probe 100 can be identified at the start of pullback and at the end of the pullback… The distance traversed between the radiopaque marker at sequence (ii) and (iv) is the pullback distance… System 10 can map this known pullback distance along the artery shape, such as in a linear fashion.” (Petroff, ¶[0240]).
“OCT data and Non-OCT data (e.g., angiography data) can be registered (e.g., correlated)… using the location, size, and shape of one or more side branches of the selected artery.” (Petroff, ¶[0184]).
Together, these passages show that Petroff’s algorithm mathematically ties the OCT pullback to angiography through co-registration/correlation and distance conversion, forming the computational basis for all subsequent size determinations. Because Algorithm 51’s time-to-distance conversion uses angiographic/landmark co-registration, the vessel geometry derived in extravascular images is, by definition, produced on the correlated pullback scale; the second-region measurements below therefore inherit that same correlation.
(B) Using the correlation-based mapping to determine size in second regions.
“System 10 can be configured to delineate the portion of a pullback which is clear… If the tissue at the end portions is diseased, angiography data can be analyzed to determine the extent of stenosis proximal and distal to the clear portion of the pullback. Subsequently, Rd is calculated for these areas outside of the delineated pullback.” (Petroff, ¶[0232]).
“System 10 can be configured to calculate (e.g., via algorithm 51) the branch angle … In some embodiments, the branch angle is used by algorithm 51 to calculate the side branch vessel diameter …” (Petroff, ¶[0180]).
This step uses the same co-registered angiographic framework established above to identify, measure, and calculate dimensions in regions proximal or distal to the clear OCT section (i.e., second regions represented in extravascular images). These second-region geometric results are then used in downstream calculations (e.g., Rd/flow), further confirming they derive from the same co-registered framework established in (A). Petroff further specifies that Algorithm 51 provides the quantitative inputs used when Rd is computed in second/branch regions: (i) it derives TIMI velocity for the resistor model that outputs side-branch flow/pressure (Petroff ¶[0241]; ¶[0219]), and (ii) it calculates side-branch diameter itself (Petroff ¶[0180]).
(C) Side-branch correlation reinforcing measurement continuity across regions.
“System 10 is configured to identify one or more side branches of the imaged vessel… based on both OCT data and non-OCT data (e.g., angiography data)… In some embodiments, ostial diameter of a side branch is calculated by system 10.” (Petroff, ¶[0261]).
This shows that even branch geometry, which may fall outside the primary OCT pullback, is derived from the same correlated data sources, further confirming the system’s correlation-based computation of vessel sizes in multiple regions.
(D) Additional supporting passages confirming geometry and flow derived from extravascular images.
“In some embodiments, non-OCT data is analyzed to identify… vessel geometries… vessel diameters…” (Petroff, ¶[0183]).
“In Step 1320, cardiovascular flow dynamics can be calculated based on the analyzed data (e.g., the OCT data and/or Non-OCT data collected and/or analyzed).” (Petroff, ¶[0185]).
“If there is disease at a side branch… the unimaged branch resistance from disease, Rd, is calculated… Rd2 can be estimated from angiography or from a more distal OCT pullback.” (Petroff, ¶[0217]).
Arguments Conclusion. Petroff’s disclosures collectively demonstrate that the system first correlates OCT pullback to angiography through algorithmic co-registration, converts pullback time to spatial distance, and then applies that same correlated framework to determine vessel size and hemodynamic parameters in second regions (e.g., distal or proximal areas, side branches). Therefore, the second-region size determination in Petroff is necessarily based on the correlation derived from the pullback length, directly addressing and refuting Applicant’s argument.
35 U.S.C. §102/103
Applicant's arguments filed 10/16/2025, pages 7-8, regarding the previous 102/103 Rejections of claims 3-4, 11, 14-15, and 19 have been fully considered but are not persuasive. For the same reasons outline above in the response to the 102 arguments, the Applicant’s arguments are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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 AARON MERRIAM whose telephone number is (703) 756-
5938. The examiner can normally be reached M-F 8:00 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing
using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is
encouraged to use the USPTO Automated Interview Request (AIR) at
http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
supervisor, Jason Sims can be reached on (571)272-4867. The fax phone number for the
organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained
from Patent Center. Unpublished application information in Patent Center is available to
registered users. To file and manage patent submissions in Patent Center, visit:
https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for
more information about Patent Center and https://www.uspto.gov/patents/docx for
information about filing in DOCX format. For additional questions, contact the Electronic
Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO
Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
Prosecution Insights