DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The proposed reply filled on 11/20/2025 has been entered. Claims 1-20 remain pending in the application.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6-11, 13-18, and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Huennekens et al (US Pub No. 2006/0241465) in the view of Zarkh et al. (US Pub No. 2007/0116342).
Regarding claim 1, Huennekens teaches a method, comprising:
receiving, by one or more processors, vessel data including image data for a vessel, wherein the image data includes angiography image data and intravascular image data (para. 0041; A co-registration processor 30 receives IVUS image data from the catheter image processor 26 via line 32 and radiological image data from the radiological image processor 18 via line 34.);
determining, by the one or more processors based on the vessel data, diameter values for at least a portion of the vessel (para. 0071; the diameter value of a portion of the vessel is measure and displayed);
determining, by the one or more processors based on the vessel data, a lumen area from a set of area values determined at positions along at least the portion of the vessel (figure 10, para. 0071; The display also includes a variety of additional text information associated with the section of the vessel identified by the marker artifact 1020. Vessel dimensions 1030 specify an approximate diameter and lumen area of a particular cross section indicated by the marker artifact 1020's current position on the enhanced radiological image 1010.);
automatically generating, by the one or more processors based, a two-dimensional representation (para. 0069; the longitudinal IVUS grayscale image and/or the color (Virtual Histology) image);
providing for output, by the one or more processors, the two-dimensional representation of the vessel, an angiography image frame, and an intravascular image frame (paras. 0069-0070; the co-registration image further includes an IVUS cross-sectional image (not depicted) corresponding to the vessel segment indicated by the marker artifact 1020 on the enhanced radiological image 1010. The examiner notes that the output displays the two dimensional representation which is the IVUS cross sectional image and the angiographic image which is the enhanced radiological image.);
providing for output, by the one or more processors based on at least one selected frame, a diameter value associated with the at least one selected frame, wherein the diameter value is provided relative to the intravascular image frame (paras. 0070-0071; The enhanced radiological image 1010 comprises a marker artifact 1020 superimposed upon an angiogram image. The marker artifact 1020 indicates the point at which the presently displayed functional flow measurements are being presented based upon measurements previously acquired by sensors/transducers on the probe 22 mounted at the distal end of a flexible elongate member such as a guidewire or the catheter 20. the co-registration image further includes an IVUS cross-sectional image (not depicted) corresponding to the vessel segment indicated by the marker artifact 1020 on the enhanced radiological image 1010. The display also includes a variety of additional text information associated with the section of the vessel identified by the marker artifact 1020. Vessel dimensions 1030 specify an approximate diameter and lumen area of a particular cross section indicated by the marker artifact 1020's current position on the enhanced radiological image 1010.);
providing for output, by the one or more processors based on the at least one selected frame, an area value associated with the at least one selected frame, wherein the area value is provided relative to the intravascular image frame (paras. 0070-0071; The enhanced radiological image 1010 comprises a marker artifact 1020 superimposed upon an angiogram image. The marker artifact 1020 indicates the point at which the presently displayed functional flow measurements are being presented based upon measurements previously acquired by sensors/transducers on the probe 22 mounted at the distal end of a flexible elongate member such as a guidewire or the catheter 20. the co-registration image further includes an IVUS cross-sectional image (not depicted) corresponding to the vessel segment indicated by the marker artifact 1020 on the enhanced radiological image 1010. The display also includes a variety of additional text information associated with the section of the vessel identified by the marker artifact 1020. Vessel dimensions 1030 specify an approximate diameter and lumen area of a particular cross section indicated by the marker artifact 1020's current position on the enhanced radiological image 1010.); and
providing for output, by the one or more processors, cross-sectional area values represented by the two-dimensional representation of the vessel (paras. 0070-0071; The enhanced radiological image 1010 comprises a marker artifact 1020 superimposed upon an angiogram image. The marker artifact 1020 indicates the point at which the presently displayed functional flow measurements are being presented based upon measurements previously acquired by sensors/transducers on the probe 22 mounted at the distal end of a flexible elongate member such as a guidewire or the catheter 20. the co-registration image further includes an IVUS cross-sectional image (not depicted) corresponding to the vessel segment indicated by the marker artifact 1020 on the enhanced radiological image 1010. The display also includes a variety of additional text information associated with the section of the vessel identified by the marker artifact 1020. Vessel dimensions 1030 specify an approximate diameter and lumen area of a particular cross section indicated by the marker artifact 1020's current position on the enhanced radiological image 1010.).
However, Huennekens fails to explicitly teach determining, by the one or more processors based on the vessel data, a minimum lumen area (MLA) from a set of area values determined at positions along at least the portion of the vessel; generating, by the one or more processors based on the determined diameter values or area values, a two-dimensional representation of a longitudinal section of the vessel that identifies absolute cross-sectional mean diameter values or absolute cross-sectional area values of the vessel, wherein the two-dimensional representation is configured as a vessel profile that is symmetrical relative to a longest axis of the two-dimensional representation; and providing for output, by the one or more processors, cross-sectional mean diameter values or cross-sectional area values represented by the two-dimensional representation of the vessel, including an indication of a value for the MLA.
Zarkh, in the same field of endeavor, teaches determining, by the one or more processors based on the vessel data, a minimum lumen area (MLA) from a set of area values determined at positions along at least the portion of the vessel (figure 34, para. 0219; quantitative analysis of the vessel of interest (FIG. 34) in the form of graphs and specific measurements, such as percent narrowing (diameter and area), length, plaque volume, minimal lumen diameter and area, reference (healthy) area and diameter measures, eccentricity index and angulation.); generating, by the one or more processors based on the determined diameter values or area values, a two-dimensional representation of a longitudinal section of the vessel that identifies absolute cross-sectional mean diameter values or absolute cross-sectional area values of the vessel, wherein the two-dimensional representation is configured as a vessel profile that is symmetrical relative to a longest axis of the two-dimensional representation (figure 34, paras. 0127, 0216, and 0219; One or more graphs (see, for example, screen shot, FIG. 34) may be presented including a graph for representing the cross-section area (fusion output) data and one for diameter information, or a combined graph. A diameter data graph may be referred to "eccentricity", as it presents maximum and minimum diameter value for every point along the vessel. Quantitative analysis of the vessel of interest (FIG. 34) in the form of graphs and specific measurements, such as percent narrowing (diameter and area), length, plaque volume, minimal lumen diameter and area, reference (healthy) area and diameter measures, eccentricity index and angulation. The examiner notes that figure 34 shows a graph representing the vessel diameter profile, where it shows the contours of the vessel and the diameters of the vessel along its length. The diameter profile is symmetrical along the length of the vessel relative to the longest axis of the vessel. See annotated figure below.); and providing for output, by the one or more processors cross-sectional mean diameter values or cross-sectional area values represented by the two-dimensional representation of the vessel, including an indication of a value for the MLA (figure 34, para. 0219; quantitative analysis of the vessel of interest (FIG. 34) in the form of graphs and specific measurements, such as percent narrowing (diameter and area), length, plaque volume, minimal lumen diameter and area, reference (healthy) area and diameter measures, eccentricity index and angulation.).
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It would have been obvious to an ordinary skilled in the art before the invention was made to modify the two-dimensional representation of Huennekens with the two dimensional representation of absolute cross-sectional mean diameter values or absolute cross-sectional area values of the vessel with an indication of a value for the MLA taught by Zarkh because it helps provide quantitative analysis of the vessel of interest (para. 0219). Further, a two dimensional longitudinal profile of absolute cross-sectional area allows the user to see how the vessel’s lumen size changes along its length which will help to identify the narrowing or diseased portion of the vessel.
Regarding claim 2, Huennekens teaches the method of claim 1, further comprising: receiving, by the one or more processors, a user input in connection with the two-dimensional representation of the vessel (paras. 0070-0072; The enhanced radiological image 1010 comprises a marker artifact 1020 superimposed upon an angiogram image and the user drags the marker along the vessel, the co-registration image further includes an IVUS cross-sectional image (not depicted) corresponding to the vessel segment indicated by the marker artifact 1020 on the enhanced radiological image 1010.); and updating, by the one or more processors in response to the user input, the two-dimensional representation of the vessel data or the intravascular image frame (paras. 0070-0072; the user drags the marker along the vessel and the display updates as the FFR and dimension values change to correspond to the new selected point).
Regarding claim 3, Huennekens teaches the method of claim 2, wherein updating the two-dimensional representation of the vessel further comprises: identifying, by the one or more processors based on the user input received in connection with the two-dimensional representation, a selected image frame (para. 0059; a "slider" control that allows an operator to track through a series of stored frames representing sequentially acquired data along a traversed path within a vessel. As the user drags and drops the cursor along the path, the co-registration processor 30 acquires and presents corresponding co-registered images. The user sequentially proceeds through the stored images using, by way of example, arrow keys, mouse buttons, etc.); and providing for output, by the one or more processors, the determined diameter value associated with the selected image frame relative to the two-dimensional representation or the intravascular image frame (paras. 0070-0072; the user drags the marker along the vessel and where the point is selected the display shows a diameter value for the selected point.).
Regarding claim 4, Huennekens teaches the method of claim 2, wherein updating the two-dimensional representation of the vessel further comprises: identifying, by the one or more processors based on the user input received in connection with the two-dimensional representation, a selected image frame (para. 0059; a "slider" control that allows an operator to track through a series of stored frames representing sequentially acquired data along a traversed path within a vessel. As the user drags and drops the cursor along the path, the co-registration processor 30 acquires and presents corresponding co-registered images. The user sequentially proceeds through the stored images using, by way of example, arrow keys, mouse buttons, etc.); and providing for output, by the one or more processors, an indication of the selected frame on the two-dimensional representation (figure 7, para. 0059; a "slider" control that allows an operator to track through a series of stored frames representing sequentially acquired data along a traversed path within a vessel. As the user drags and drops the cursor along the path, the co-registration processor 30 acquires and presents corresponding co-registered images. The user sequentially proceeds through the stored images using, by way of example, arrow keys, mouse buttons, etc.).
Regarding claim 6, Huennekens teaches the method of claim 1, further comprising providing for output, by the one or more processors, a proximal reference and a distal reference on the two-dimensional representation (paras. 0058-0059; the co-registered IVUS image 700 and enhanced radiological image 710 in a display 701 presented in FIG. 7, the operator creates a reference mark 760 at one or more points on a calculated path 750. The reference mark 760 serves a variety of potential uses. By way of example, the reference mark 760 potentially serves as a benchmark (location synchronization point) for updating position of a marker artifact 720 within the enhanced radiological image 710. the reference mark 760 is used to highlight a particular point of interest during a diagnostic/treatment procedure. A bookmark is placed within a series of cross-sectional images associated with the IVUS image 700 portion of the display 701. The bookmark allows quick access to a particular archived image frame corresponding to the reference mark 760 in the display 701.).
Regarding claim 7, Huennekens teaches the method of claim 6, wherein the at least one selected frame corresponds to the proximal reference and the distal reference (paras. 0058-0059; the co-registered IVUS image 700 and enhanced radiological image 710 in a display 701 presented in FIG. 7, the operator creates a reference mark 760 at one or more points on a calculated path 750. The reference mark 760 serves a variety of potential uses. By way of example, the reference mark 760 potentially serves as a benchmark (location synchronization point) for updating position of a marker artifact 720 within the enhanced radiological image 710. the reference mark 760 is used to highlight a particular point of interest during a diagnostic/treatment procedure. A bookmark is placed within a series of cross-sectional images associated with the IVUS image 700 portion of the display 701. The bookmark allows quick access to a particular archived image frame corresponding to the reference mark 760 in the display 701.).
Regarding claim 8, Huennekens teaches a system, comprising: one or more processors, the one or more processors configured to: receivevessel data including image data for a vessel, wherein the image data includes angiography image data and intravascular image data (para. 0041; A co-registration processor 30 receives IVUS image data from the catheter image processor 26 via line 32 and radiological image data from the radiological image processor 18 via line 34.);
determine, based on the vessel data, diameter values for at least a portion of the vessel (para. 0071; the diameter value of a portion of the vessel is measure and displayed);
determine, based on the vessel data, a lumen area from a set of area values determined at positions along at least the portion of the vessel (figure 10, para. 0071; The display also includes a variety of additional text information associated with the section of the vessel identified by the marker artifact 1020. Vessel dimensions 1030 specify an approximate diameter and lumen area of a particular cross section indicated by the marker artifact 1020's current position on the enhanced radiological image 1010.);
automatically generate a two-dimensional representation (para. 0069; the longitudinal IVUS grayscale image and/or the color (Virtual Histology) image);
provide for output the two-dimensional representation of the vessel, an angiography image frame, and an intravascular image frame (paras. 0069-0070; the co-registration image further includes an IVUS cross-sectional image (not depicted) corresponding to the vessel segment indicated by the marker artifact 1020 on the enhanced radiological image 1010. The examiner notes that the output displays the two dimensional representation which is the IVUS cross sectional image and the angiographic image which is the enhanced radiological image.);
provide for output, based on at least one selected frame, a diameter value associated with the at least one selected frame, wherein the diameter value is provided relative to the intravascular image frame (paras. 0070-0071; The enhanced radiological image 1010 comprises a marker artifact 1020 superimposed upon an angiogram image. The marker artifact 1020 indicates the point at which the presently displayed functional flow measurements are being presented based upon measurements previously acquired by sensors/transducers on the probe 22 mounted at the distal end of a flexible elongate member such as a guidewire or the catheter 20. the co-registration image further includes an IVUS cross-sectional image (not depicted) corresponding to the vessel segment indicated by the marker artifact 1020 on the enhanced radiological image 1010. The display also includes a variety of additional text information associated with the section of the vessel identified by the marker artifact 1020. Vessel dimensions 1030 specify an approximate diameter and lumen area of a particular cross section indicated by the marker artifact 1020's current position on the enhanced radiological image 1010.);
provide for output, based on the at least one selected frame, an area value associated with the at least one selected frame, wherein the area value is provided relative to the intravascular image frame (paras. 0070-0071; The enhanced radiological image 1010 comprises a marker artifact 1020 superimposed upon an angiogram image. The marker artifact 1020 indicates the point at which the presently displayed functional flow measurements are being presented based upon measurements previously acquired by sensors/transducers on the probe 22 mounted at the distal end of a flexible elongate member such as a guidewire or the catheter 20. the co-registration image further includes an IVUS cross-sectional image (not depicted) corresponding to the vessel segment indicated by the marker artifact 1020 on the enhanced radiological image 1010. The display also includes a variety of additional text information associated with the section of the vessel identified by the marker artifact 1020. Vessel dimensions 1030 specify an approximate diameter and lumen area of a particular cross section indicated by the marker artifact 1020's current position on the enhanced radiological image 1010.); and
provide for output cross-sectional area values represented by the two-dimensional representation of the vessel (paras. 0070-0071; The enhanced radiological image 1010 comprises a marker artifact 1020 superimposed upon an angiogram image. The marker artifact 1020 indicates the point at which the presently displayed functional flow measurements are being presented based upon measurements previously acquired by sensors/transducers on the probe 22 mounted at the distal end of a flexible elongate member such as a guidewire or the catheter 20. the co-registration image further includes an IVUS cross-sectional image (not depicted) corresponding to the vessel segment indicated by the marker artifact 1020 on the enhanced radiological image 1010. The display also includes a variety of additional text information associated with the section of the vessel identified by the marker artifact 1020. Vessel dimensions 1030 specify an approximate diameter and lumen area of a particular cross section indicated by the marker artifact 1020's current position on the enhanced radiological image 1010.).
However, Huennekens fails to explicitly teach determine, based on the vessel data, a minimum lumen area (MLA) from a set of area values determined at positions along at least the portion of the vessel; generate, based on the determined diameter values or area values, a two-dimensional representation of a longitudinal section of the vessel that identifies absolute cross- sectional mean diameter values or absolute cross-sectional area values of the vessel, wherein the two- dimensional representation is configured as a vessel profile that is symmetrical relative to a longest axis of the two-dimensional representation; and provide for output cross-sectional mean diameter values or cross-sectional area values represented by the two-dimensional representation of the vessel, including an indication of a value for the MLA.
Zarkh, in the same field of endeavor, teaches determine, based on the vessel data, a minimum lumen area (MLA) from a set of area values determined at positions along at least the portion of the vessel (figure 34, para. 0219; quantitative analysis of the vessel of interest (FIG. 34) in the form of graphs and specific measurements, such as percent narrowing (diameter and area), length, plaque volume, minimal lumen diameter and area, reference (healthy) area and diameter measures, eccentricity index and angulation.); generate, based on the determined diameter values or area values, a two-dimensional representation of a longitudinal section of the vessel that identifies absolute cross- sectional mean diameter values or absolute cross-sectional area values of the vessel, wherein the two- dimensional representation is configured as a vessel profile that is symmetrical relative to a longest axis of the two-dimensional representation (figure 34, paras. 0127, 0216, and 0219; One or more graphs (see, for example, screen shot, FIG. 34) may be presented including a graph for representing the cross-section area (fusion output) data and one for diameter information, or a combined graph. A diameter data graph may be referred to "eccentricity", as it presents maximum and minimum diameter value for every point along the vessel. Quantitative analysis of the vessel of interest (FIG. 34) in the form of graphs and specific measurements, such as percent narrowing (diameter and area), length, plaque volume, minimal lumen diameter and area, reference (healthy) area and diameter measures, eccentricity index and angulation. The examiner notes that figure 34 shows a graph representing the vessel diameter profile, where it shows the contours of the vessel and the diameters of the vessel along its length. The diameter profile is symmetrical along the length of the vessel relative to the longest axis of the vessel. See annotated figure below.); and provide for output cross-sectional mean diameter values or cross-sectional area values represented by the two-dimensional representation of the vessel, including an indication of a value for the MLA (figure 34, para. 0219; quantitative analysis of the vessel of interest (FIG. 34) in the form of graphs and specific measurements, such as percent narrowing (diameter and area), length, plaque volume, minimal lumen diameter and area, reference (healthy) area and diameter measures, eccentricity index and angulation.).
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It would have been obvious to an ordinary skilled in the art before the invention was made to modify the two-dimensional representation of Huennekens with the two dimensional representation of absolute cross-sectional mean diameter values or absolute cross-sectional area values of the vessel with an indication of a value for the MLA taught by Zarkh because it helps provide quantitative analysis of the vessel of interest (para. 0219). Further, a two dimensional longitudinal profile of absolute cross-sectional area allows the user to see how the vessel’s lumen size changes along its length which will help to identify the narrowing or diseased portion of the vessel.
Regarding claim 9, Huennekens teaches the system of claim 8, wherein the one or more processors are further configured to: receive a user input in connection with the two-dimensional representation of the vessel; and update, in response to the user input, the two-dimensional representation of the vessel or the intravascular image frame (paras. 0070-0072; The enhanced radiological image 1010 comprises a marker artifact 1020 superimposed upon an angiogram image and the user drags the marker along the vessel, the co-registration image further includes an IVUS cross-sectional image (not depicted) corresponding to the vessel segment indicated by the marker artifact 1020 on the enhanced radiological image 1010).
Regarding claim 10, Huennekens teaches the system of claim 9, wherein updating the two-dimensional representation of the vessel further comprises: identifying, based on the user input received in connection with the two-dimensional representation, a selected image frame (para. 0059; a "slider" control that allows an operator to track through a series of stored frames representing sequentially acquired data along a traversed path within a vessel. As the user drags and drops the cursor along the path, the co-registration processor 30 acquires and presents corresponding co-registered images. The user sequentially proceeds through the stored images using, by way of example, arrow keys, mouse buttons, etc.); and providing for output the determined diameter value associated with the selected image frame relative to the two-dimensional representation or the intravascular image frame (paras. 0070-0072; the user drags the marker along the vessel and where the point is selected the display shows a diameter value for the selected point.).
Regarding claim 11, Huennekens teaches the system of claim 9, wherein updating the two-dimensional representation of the vessel further comprises: identifying, based on the user input received in connection with the two-dimensional representation, a selected image frame (para. 0059; a "slider" control that allows an operator to track through a series of stored frames representing sequentially acquired data along a traversed path within a vessel. As the user drags and drops the cursor along the path, the co-registration processor 30 acquires and presents corresponding co-registered images. The user sequentially proceeds through the stored images using, by way of example, arrow keys, mouse buttons, etc.); and providing for output an indication of the selected frame on the two-dimensional representation (figure 7, para. 0059; a "slider" control that allows an operator to track through a series of stored frames representing sequentially acquired data along a traversed path within a vessel. As the user drags and drops the cursor along the path, the co-registration processor 30 acquires and presents corresponding co-registered images. The user sequentially proceeds through the stored images using, by way of example, arrow keys, mouse buttons, etc.).
Regarding claim 13, Huennekens teaches the system of claim 8, further comprising providing for output, by the one or more processors, a proximal reference and a distal reference on the two-dimensional representation (paras. 0058-0059; the co-registered IVUS image 700 and enhanced radiological image 710 in a display 701 presented in FIG. 7, the operator creates a reference mark 760 at one or more points on a calculated path 750. The reference mark 760 serves a variety of potential uses. By way of example, the reference mark 760 potentially serves as a benchmark (location synchronization point) for updating position of a marker artifact 720 within the enhanced radiological image 710. the reference mark 760 is used to highlight a particular point of interest during a diagnostic/treatment procedure. A bookmark is placed within a series of cross-sectional images associated with the IVUS image 700 portion of the display 701. The bookmark allows quick access to a particular archived image frame corresponding to the reference mark 760 in the display 701.).
Regarding claim 14, Huennekens teaches the system of claim 13, wherein the at least one selected frame corresponds to the proximal reference and the distal reference (paras. 0058-0059; the co-registered IVUS image 700 and enhanced radiological image 710 in a display 701 presented in FIG. 7, the operator creates a reference mark 760 at one or more points on a calculated path 750. The reference mark 760 serves a variety of potential uses. By way of example, the reference mark 760 potentially serves as a benchmark (location synchronization point) for updating position of a marker artifact 720 within the enhanced radiological image 710. the reference mark 760 is used to highlight a particular point of interest during a diagnostic/treatment procedure. A bookmark is placed within a series of cross-sectional images associated with the IVUS image 700 portion of the display 701. The bookmark allows quick access to a particular archived image frame corresponding to the reference mark 760 in the display 701.).
Regarding claim 15, Huennekens teaches One or more non-transitory computer readable medium storing instructions which, when executed by one or more processors, cause the one or more processors to: receive vessel data including image data for a vessel, wherein the image data includes angiography image data and intravascular image data (para. 0041; A co-registration processor 30 receives IVUS image data from the catheter image processor 26 via line 32 and radiological image data from the radiological image processor 18 via line 34.);
determine, based on the vessel data, diameter values for at least a portion of the vessel (para. 0071; the diameter value of a portion of the vessel is measure and displayed);
determine, based on the vessel data, a lumen area from a set of area values determined at positions along at least the portion of the vessel (figure 10, para. 0071; The display also includes a variety of additional text information associated with the section of the vessel identified by the marker artifact 1020. Vessel dimensions 1030 specify an approximate diameter and lumen area of a particular cross section indicated by the marker artifact 1020's current position on the enhanced radiological image 1010.);
automatically generate a two-dimensional representation (para. 0069; the longitudinal IVUS grayscale image and/or the color (Virtual Histology) image);
provide for output the two-dimensional representation of the vessel, an angiography image frame, and an intravascular image frame (paras. 0069-0070; the co-registration image further includes an IVUS cross-sectional image (not depicted) corresponding to the vessel segment indicated by the marker artifact 1020 on the enhanced radiological image 1010. The examiner notes that the output displays the two dimensional representation which is the IVUS cross sectional image and the angiographic image which is the enhanced radiological image.);
provide for output, based on at least one selected frame, a diameter value associated with the at least one selected frame, wherein the diameter value is provided relative to the intravascular image frame (paras. 0070-0071; The enhanced radiological image 1010 comprises a marker artifact 1020 superimposed upon an angiogram image. The marker artifact 1020 indicates the point at which the presently displayed functional flow measurements are being presented based upon measurements previously acquired by sensors/transducers on the probe 22 mounted at the distal end of a flexible elongate member such as a guidewire or the catheter 20. the co-registration image further includes an IVUS cross-sectional image (not depicted) corresponding to the vessel segment indicated by the marker artifact 1020 on the enhanced radiological image 1010. The display also includes a variety of additional text information associated with the section of the vessel identified by the marker artifact 1020. Vessel dimensions 1030 specify an approximate diameter and lumen area of a particular cross section indicated by the marker artifact 1020's current position on the enhanced radiological image 1010.);
provide for output, based on the at least one selected frame, an area value associated with the at least one selected frame, wherein the area value is provided relative to the intravascular image frame (paras. 0070-0071; The enhanced radiological image 1010 comprises a marker artifact 1020 superimposed upon an angiogram image. The marker artifact 1020 indicates the point at which the presently displayed functional flow measurements are being presented based upon measurements previously acquired by sensors/transducers on the probe 22 mounted at the distal end of a flexible elongate member such as a guidewire or the catheter 20. the co-registration image further includes an IVUS cross-sectional image (not depicted) corresponding to the vessel segment indicated by the marker artifact 1020 on the enhanced radiological image 1010. The display also includes a variety of additional text information associated with the section of the vessel identified by the marker artifact 1020. Vessel dimensions 1030 specify an approximate diameter and lumen area of a particular cross section indicated by the marker artifact 1020's current position on the enhanced radiological image 1010.); and
provide for output cross-sectional area values represented by the two-dimensional representation of the vessel (paras. 0070-0071; The enhanced radiological image 1010 comprises a marker artifact 1020 superimposed upon an angiogram image. The marker artifact 1020 indicates the point at which the presently displayed functional flow measurements are being presented based upon measurements previously acquired by sensors/transducers on the probe 22 mounted at the distal end of a flexible elongate member such as a guidewire or the catheter 20. the co-registration image further includes an IVUS cross-sectional image (not depicted) corresponding to the vessel segment indicated by the marker artifact 1020 on the enhanced radiological image 1010. The display also includes a variety of additional text information associated with the section of the vessel identified by the marker artifact 1020. Vessel dimensions 1030 specify an approximate diameter and lumen area of a particular cross section indicated by the marker artifact 1020's current position on the enhanced radiological image 1010.).
However, Huennekens fails to explicitly teach determine, based on the vessel data, a minimum lumen area (MLA) from a set of area values determined at positions along at least the portion of the vessel; generate, based on the determined diameter values or area values, a two-dimensional representation of a longitudinal section of the vessel that identifies absolute cross- sectional mean diameter values or absolute cross-sectional area values of the vessel, wherein the two- dimensional representation is configured as a vessel profile that is symmetrical relative to a longest axis of the two-dimensional representation; and provide for output cross-sectional mean diameter values or cross-sectional area values represented by the two-dimensional representation of the vessel, including an indication of a value for the MLA.
Zarkh, in the same field of endeavor, teaches determine, based on the vessel data, a minimum lumen area (MLA) from a set of area values determined at positions along at least the portion of the vessel (figure 34, para. 0219; quantitative analysis of the vessel of interest (FIG. 34) in the form of graphs and specific measurements, such as percent narrowing (diameter and area), length, plaque volume, minimal lumen diameter and area, reference (healthy) area and diameter measures, eccentricity index and angulation.); generate, based on the determined diameter values or area values, a two-dimensional representation of a longitudinal section of the vessel that identifies absolute cross- sectional mean diameter values or absolute cross-sectional area values of the vessel, wherein the two- dimensional representation is configured as a vessel profile that is symmetrical relative to a longest axis of the two-dimensional representation (figure 34, paras. 0127, 0216, and 0219; One or more graphs (see, for example, screen shot, FIG. 34) may be presented including a graph for representing the cross-section area (fusion output) data and one for diameter information, or a combined graph. A diameter data graph may be referred to "eccentricity", as it presents maximum and minimum diameter value for every point along the vessel. Quantitative analysis of the vessel of interest (FIG. 34) in the form of graphs and specific measurements, such as percent narrowing (diameter and area), length, plaque volume, minimal lumen diameter and area, reference (healthy) area and diameter measures, eccentricity index and angulation. The examiner notes that figure 34 shows a graph representing the vessel diameter profile, where it shows the contours of the vessel and the diameters of the vessel along its length. The diameter profile is symmetrical along the length of the vessel relative to the longest axis of the vessel. See annotated figure below.); and provide for output cross-sectional mean diameter values or cross-sectional area values represented by the two-dimensional representation of the vessel, including an indication of a value for the MLA (figure 34, para. 0219; quantitative analysis of the vessel of interest (FIG. 34) in the form of graphs and specific measurements, such as percent narrowing (diameter and area), length, plaque volume, minimal lumen diameter and area, reference (healthy) area and diameter measures, eccentricity index and angulation.).
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It would have been obvious to an ordinary skilled in the art before the invention was made to modify the two-dimensional representation of Huennekens with the two dimensional representation of absolute cross-sectional mean diameter values or absolute cross-sectional area values of the vessel with an indication of a value for the MLA taught by Zarkh because it helps provide quantitative analysis of the vessel of interest (para. 0219). Further, a two dimensional longitudinal profile of absolute cross-sectional area allows the user to see how the vessel’s lumen size changes along its length which will help to identify the narrowing or diseased portion of the vessel.
Regarding claim 16, Huennekens teaches the one or more non-transitory computer readable medium of claim 15, wherein the instructions further cause the one or more processors to: receive a user input in connection with the two-dimensional representation of the vessel; and update, in response to the user input, the two-dimensional representation of the vessel or the intravascular image frame (paras. 0070-0072; The enhanced radiological image 1010 comprises a marker artifact 1020 superimposed upon an angiogram image and the user drags the marker along the vessel, the co-registration image further includes an IVUS cross-sectional image (not depicted) corresponding to the vessel segment indicated by the marker artifact 1020 on the enhanced radiological image 1010).
Regarding claim 17, Huennekens teaches the one or more non-transitory computer readable medium of claim 16, wherein updating the two-dimensional representation of the vessel further comprises: identifying, based on the user input received in connection with the two-dimensional representation, a selected image frame (para. 0059; a "slider" control that allows an operator to track through a series of stored frames representing sequentially acquired data along a traversed path within a vessel. As the user drags and drops the cursor along the path, the co-registration processor 30 acquires and presents corresponding co-registered images. The user sequentially proceeds through the stored images using, by way of example, arrow keys, mouse buttons, etc.); and providing for output the determined diameter value associated with the selected image frame relative to the two-dimensional representation or the intravascular image frame (paras. 0070-0072; the user drags the marker along the vessel and where the point is selected the display shows a diameter value for the selected point.).
Regarding claim 18, Huennekens teaches the one or more non-transitory computer readable medium of claim 16, wherein updating the two-dimensional representation of the vessel further comprises: identifying, based on the user input received in connection with the two-dimensional representation, a selected image frame (para. 0059; a "slider" control that allows an operator to track through a series of stored frames representing sequentially acquired data along a traversed path within a vessel. As the user drags and drops the cursor along the path, the co-registration processor 30 acquires and presents corresponding co-registered images. The user sequentially proceeds through the stored images using, by way of example, arrow keys, mouse buttons, etc.); and providing for output an indication of the selected frame on the two-dimensional representation (figure 7, para. 0059; a "slider" control that allows an operator to track through a series of stored frames representing sequentially acquired data along a traversed path within a vessel. As the user drags and drops the cursor along the path, the co-registration processor 30 acquires and presents corresponding co-registered images. The user sequentially proceeds through the stored images using, by way of example, arrow keys, mouse buttons, etc.).
Regarding claim 20, Huennekens teaches the one or more non-transitory computer readable medium of claim 15, wherein the instructions further cause the one or more processors to provide for output a proximal reference and a distal reference on the two-dimensional representation (paras. 0058-0059; the co-registered IVUS image 700 and enhanced radiological image 710 in a display 701 presented in FIG. 7, the operator creates a reference mark 760 at one or more points on a calculated path 750. The reference mark 760 serves a variety of potential uses. By way of example, the reference mark 760 potentially serves as a benchmark (location synchronization point) for updating position of a marker artifact 720 within the enhanced radiological image 710. the reference mark 760 is used to highlight a particular point of interest during a diagnostic/treatment procedure. A bookmark is placed within a series of cross-sectional images associated with the IVUS image 700 portion of the display 701. The bookmark allows quick access to a particular archived image frame corresponding to the reference mark 760 in the display 701.).
Claims 5, 12, and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Huennekens et al (US Pub No. 2006/0241465) in the view of Zarkh et al. (US Pub No. 2007/0116342) in further view of Barlis (NPL: “The use of intracoronary optical coherence tomography in interventional cardiology: saftety, feasibility and clinical applications).
Regarding claim 5, Huennekens teaches the method of claim 1, further comprising: identifying, by the one or more processors based on the vessel data, a branch of the vessel (para. 0045; Thus, side branches such as side branch 210 and other vasculature landmarks can be displayed and seen clearly on the radiological image portion of a co-registered image displayed upon the graphical display device 50.).
However, fails to explicitly teach providing for output, by the one or more processors, an indication of the branch aligned along the longest axis of the two-dimensional representation.
Barlis, in the same field of endeavor, teaches providing for output, by the one or more processors, an indication of the branch aligned along the longest axis of the two-dimensional representation (figure 1, page 278; Matching of the OCT and IVUS pullbacks. The position of the IVUS, Optical Coherence Tomography (OCT) and Intravascular Magnetic Resonance Spectroscopy (IVMR) probe along the vessel was filmed before and after each acquisition (A). The “matching” of the region of interest in the IVUS (B) and OCT (C) pullback was based on the presence of anatomical landmarks (e.g. side branches visible in the longitudinal and crosssectional views). To determine the longitudinal position of the IVMR probe in the vessel, a side branch was used as a marker. From the landmark to the proximal part of the vessel one frame every 1.6 mm was selected. D1: first diagonal, D2: second diagonal, SB: septal branch, LAD: left anterior descendent coronary artery. CS: cross section.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the two-dimensional representation of Huennekens in the view of Zarkh with the two dimensional representation that has an indication of the branch aligned along the longest axis taught by Barlis because it helps see exactly where the branch originates in relation to changes in the vessel size. This helps correlate narrowing or other features with anatomical landmarks which improves interpretation and planning.
Regarding claim 12, Huennekens teaches the system of claim 8, wherein the one or more processors are further configured to: identify, based on the vessel data, a branch of the vessel (para. 0045; Thus, side branches such as side branch 210 and other vasculature landmarks can be displayed and seen clearly on the radiological image portion of a co-registered image displayed upon the graphical display device 50.).
However, fails to explicitly teach provide for output an indication of the branch aligned along the longest axis of the two-dimensional representation.
Barlis, in the same field of endeavor, teaches provide for output an indication of the branch aligned along the longest axis of the two-dimensional representation (figure 1, page 278; Matching of the OCT and IVUS pullbacks. The position of the IVUS, Optical Coherence Tomography (OCT) and Intravascular Magnetic Resonance Spectroscopy (IVMR) probe along the vessel was filmed before and after each acquisition (A). The “matching” of the region of interest in the IVUS (B) and OCT (C) pullback was based on the presence of anatomical landmarks (e.g. side branches visible in the longitudinal and crosssectional views). To determine the longitudinal position of the IVMR probe in the vessel, a side branch was used as a marker. From the landmark to the proximal part of the vessel one frame every 1.6 mm was selected. D1: first diagonal, D2: second diagonal, SB: septal branch, LAD: left anterior descendent coronary artery. CS: cross section.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the two-dimensional representation of Huennekens in the view of Zarkh with the two dimensional representation that has an indication of the branch aligned along the longest axis taught by Barlis because it helps see exactly where the branch originates in relation to changes in the vessel size. This helps correlate narrowing or other features with anatomical landmarks which improves interpretation and planning.
Regarding claim 19, Huennekens teaches the one or more non-transitory computer readable medium of claim 15, wherein the instructions further cause the one or more processors to: identify, based on the vessel data, a branch of the vessel (para. 0045; Thus, side branches such as side branch 210 and other vasculature landmarks can be displayed and seen clearly on the radiological image portion of a co-registered image displayed upon the graphical display device 50.).
However, fails to explicitly teach provide for output an indication of the branch aligned along the longest axis of the two-dimensional representation.
Barlis, in the same field of endeavor, teaches provide for output an indication of the branch aligned along the longest axis of the two-dimensional representation (figure 1, page 278; Matching of the OCT and IVUS pullbacks. The position of the IVUS, Optical Coherence Tomography (OCT) and Intravascular Magnetic Resonance Spectroscopy (IVMR) probe along the vessel was filmed before and after each acquisition (A). The “matching” of the region of interest in the IVUS (B) and OCT (C) pullback was based on the presence of anatomical landmarks (e.g. side branches visible in the longitudinal and crosssectional views). To determine the longitudinal position of the IVMR probe in the vessel, a side branch was used as a marker. From the landmark to the proximal part of the vessel one frame every 1.6 mm was selected. D1: first diagonal, D2: second diagonal, SB: septal branch, LAD: left anterior descendent coronary artery. CS: cross section.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the two-dimensional representation of Huennekens in the view of Zarkh with the two dimensional representation that has an indication of the branch aligned along the longest axis taught by Barlis because it helps see exactly where the branch originates in relation to changes in the vessel size. This helps correlate narrowing or other features with anatomical landmarks which improves interpretation and planning.
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive. The applicant argues that Zarkh fails to teach “generate, based on the determined diameter values or area values, a two- dimensional representation of a longitudinal section of the vessel that identifies absolute cross- sectional mean diameter values or absolute cross-sectional area values of the vessel, wherein the two- dimensional representation is configured as a vessel profile that is symmetrical relative to a longest axis of the two-dimensional representation”. The examiner respectfully disagrees. Zarkh teaches generating a two dimensional representation of the vessel diameter profile where the contours of the vessel are displayed and the diameter values of the vessel along its length are represented by the axis of the graph. The contours of the vessel are symmetrical relative to the longest axis of the vessel profile (Vessel centerline) [as disclosed in figure 34 and paras. 0216 and 0219, additionally see annotated figure 34 above].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kassab et al. (US 2008/0194996) disclose a vessel profile generated based on calculated diameter values and the profile being symmetrical relative to the longest axis of the profile (figure 11).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZAINAB M ALDARRAJI whose telephone number is (571)272-8726. The examiner can normally be reached Monday-Thursday7AM-5PM EST.
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/ZAINAB MOHAMMED ALDARRAJI/ Patent Examiner, Art Unit 3797
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795