DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/06/2026 has been entered. Claims 1-20 remain pending in the current 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 Asahina et al. (US Patent No. 5,357,550).
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 configured to identify a location and a value for the MLA with respect to the two- dimensional representation of the vessel.
Asahina, 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 (claim 48, col 5, lines 15-26, and col 8, line 41 to col 9, line 31; The microcomputer 37 is designed to carry out processing of determining dimensions relating to structure of a diagnosed blood vessel and its stenosis index. In order to perform the processing, as preparatory steps, the microcomputer 37 also carries out calculation for determining the inserted position of the ultrasonic probe 21 based on the X-ray fluoroscopic image data and the cross-sectional area of the lumen of the diagnosed blood vessel based on the ultrasonic image data. The thus-determined image data relating to the blood vessel structure and its stenosis index are sent to a graphic memory 38 for composing a picture therein. For all the frame memories, the above calculation and delineation are carried out, hence forming a structure of the diagnosed blood vessel BV as shown in FIG. 10. In FIG. 10, the cross sectional areas of the lumen at the transferred positions are expressed one-dimensionally in each longitudinal direction, but are expressed two-dimensionally in the transverse direction. Moreover, there are provided two types of stenosis indexes, which are both relative values. One is a stenosis index representing the cross sectional area of the lumen and the other a stenosis index representing the diameter of the lumen. The stenosis index SI(area) representing the cross sectional area can be calculated by SI(area)={(MX-MN)/MX}.times.100(%), where MX and MN are maximum and minimum values in all of the integrated pixel numbers. The apparatus according to claim 47, wherein said stenosis calculating means comprises means for determining a maximum value of the section size value as a non-illness portion of the vascular system and a minimum value of the section size value as an illness portion of the vascular system. The examiner notes that the processor calculates the area and the diameter values of the vessel from the received vessel data and determines the maximum lumen area to define a non-illness region and the minimum lumen area to define an illness region. Thus, the minimum lumen area is calculated using the area values to define a stenosis);
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 (figs. 10-11; claim 34, col 5, lines 15-26, and col 8, line 41 to col 9, line 31; An apparatus for diagnosing a vascular system of an organism having a lumen in which an inner wall is formed therein, the vascular system including a blood vessel, the apparatus comprising: means for fluorographing the vascular system to be diagnosed by X-rays, said X-rays being transmitted through the organism and converted into electrical image signals; means for obtaining, in response to a synchronization signal, fluoroscopic two-dimensional image data in accordance with the image signals supplied by the X-ray fluorographing means; means for probing the vascular system using ultrasonic signals, the ultrasonic probing means having an ultrasonic probe transferrably inserted into the lumen of the vascular system via a catheter incorporating the ultrasonic probe, the ultrasonic probe being able to obtain ultrasonic echoes representing ultrasonic tomographic images of the vascular system, and the ultrasonic echoes being converted into electrical image signals; means for obtaining, in response to the synchronization signal, tomographic two-dimensional image data in accordance with the image signals supplied by the ultrasonic probing means; means for determining a structure of the vascular system in accordance with the fluoroscopic two-dimensional image data and the tomographic two-dimensional image data; means for designating a diameter of the ultrasonic probe; means for calculating an absolute cross-sectional area of the lumen and an absolute diameter of the lumen in accordance with data corresponding to the structure of the vascular system and the diameter of the ultrasonic probe; and means for displaying the structure of the vascular system together with the absolute cross-sectional area of the lumen and the absolute diameter of the lumen. Further, the integrated pixel number in the second frame memory is divided by that in the first frame memory to produce a ratio W.sub.2. The ratio W.sub.2 is then delineated at the second position determined by the transferred distance L.sub.2 in the memory 38. This delineation made such that the diameters W.sub.1 and W.sub.2 are parallel to each other and a center line passes perpendicularly through the diameters W.sub.1 and W.sub.2, as shown in FIG. 10. For all the frame memories, the above calculation and delineation are carried out, hence forming a structure of the diagnosed blood vessel BV as shown in FIG. 10. In FIG. 10, the cross sectional areas of the lumen at the transferred positions are expressed one-dimensionally in each longitudinal direction, but are expressed two-dimensionally in the transverse direction. The examiner notes that based on the diameter and area values calculated from the vessel data, the processor generates a 2D representation of the vessel structure that identifies the absolute diameter and area values and the representation is symmetrical relative to the longest axis of the representation, see figure 10.); 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 configured to identify a location and a value for the MLA with respect to the two- dimensional representation of the vessel (figs. 10-11; claims 34 and 48, col 8, line 41 to col 9, line 31; An apparatus for diagnosing a vascular system of an organism having a lumen in which an inner wall is formed therein, the vascular system including a blood vessel, the apparatus comprising: means for fluorographing the vascular system to be diagnosed by X-rays, said X-rays being transmitted through the organism and converted into electrical image signals; means for obtaining, in response to a synchronization signal, fluoroscopic two-dimensional image data in accordance with the image signals supplied by the X-ray fluorographing means; means for probing the vascular system using ultrasonic signals, the ultrasonic probing means having an ultrasonic probe transferrably inserted into the lumen of the vascular system via a catheter incorporating the ultrasonic probe, the ultrasonic probe being able to obtain ultrasonic echoes representing ultrasonic tomographic images of the vascular system, and the ultrasonic echoes being converted into electrical image signals; means for obtaining, in response to the synchronization signal, tomographic two-dimensional image data in accordance with the image signals supplied by the ultrasonic probing means; means for determining a structure of the vascular system in accordance with the fluoroscopic two-dimensional image data and the tomographic two-dimensional image data; means for designating a diameter of the ultrasonic probe; means for calculating an absolute cross-sectional area of the lumen and an absolute diameter of the lumen in accordance with data corresponding to the structure of the vascular system and the diameter of the ultrasonic probe; and means for displaying the structure of the vascular system together with the absolute cross-sectional area of the lumen and the absolute diameter of the lumen. The apparatus according to claim 37, wherein said transferred position searching means comprises subtraction means for performing a subtraction pixel-by-pixel between a first fluoroscopic two-dimensional image data value and a subsequent fluoroscopic two-dimensional image data value. Moreover, there are provided two types of stenosis indexes, which are both relative values. One is a stenosis index representing the cross sectional area of the lumen and the other a stenosis index representing the diameter of the lumen. The stenosis index SI(area) representing the cross sectional area can be calculated by SI(area)={(MX-MN)/MX}.times.100(%), where MX and MN are maximum and minimum values in all of the integrated pixel numbers. The stenosis index SI(diam.) representing the lumen diameter can be calculated by SI(diam.)={(MX.sup.1/2 -MN.sup.1/2)/MX.sup.1/2 }.times.100 (%) Both of the indexes SI(area) and SI(diam.) are delineated in the graphic memory 38.The stored data in the graphic memory 38 is then supplied, under control of the controller 17, to the X-ray image monitor 15 by way of the D-A converter 39. As a result, the structure of the blood vessel BV is displayed with the two stenosis indexes, as shown in FIG. 11. The image of FIG. 11 can be displayed, either independently of the fluoroscopic X-ray image or superimposedly with it. The structure image shown in FIG. 11 provides a highly concrete figure. The operator can observe easily and understandably the lumen BV.sub.LM, especially its details at each point in the longitudinal direction of the vessel. Therefore, the apparatus here can provide more accurate information, including stenosis indexes, of the blood vessel, compared with the conventional techniques. The examiner notes that the two dimensional representation of the vessel is displayed along with the absolute area and diameter values and an indication of the stenosis location where the minimum lumen area and diameter are located along with a stenosis index representing the minimum cross sectional area of the lumen and the other a stenosis index representing the minimum diameter of the lumen, see figure 11 that shows the vertical line as an indication of the stenosis along with stenosis index values).
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 Asahina because it helps the operator to easily and understandably observe the lumen, especially its details at each point in the longitudinal direction of the vessel. Therefore, it can provide more accurate information, including stenosis indexes, of the blood vessel as disclosed within Asahina in col 9, lines 24-31.
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: 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 configured to identify of a location and value for the MLA with respect to the two-dimensional representation of the vessel.
Asahina, 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 (claim 48, col 5, lines 15-26, and col 8, line 41 to col 9, line 31; The microcomputer 37 is designed to carry out processing of determining dimensions relating to structure of a diagnosed blood vessel and its stenosis index. In order to perform the processing, as preparatory steps, the microcomputer 37 also carries out calculation for determining the inserted position of the ultrasonic probe 21 based on the X-ray fluoroscopic image data and the cross-sectional area of the lumen of the diagnosed blood vessel based on the ultrasonic image data. The thus-determined image data relating to the blood vessel structure and its stenosis index are sent to a graphic memory 38 for composing a picture therein. For all the frame memories, the above calculation and delineation are carried out, hence forming a structure of the diagnosed blood vessel BV as shown in FIG. 10. In FIG. 10, the cross sectional areas of the lumen at the transferred positions are expressed one-dimensionally in each longitudinal direction, but are expressed two-dimensionally in the transverse direction. Moreover, there are provided two types of stenosis indexes, which are both relative values. One is a stenosis index representing the cross sectional area of the lumen and the other a stenosis index representing the diameter of the lumen. The stenosis index SI(area) representing the cross sectional area can be calculated by SI(area)={(MX-MN)/MX}.times.100(%), where MX and MN are maximum and minimum values in all of the integrated pixel numbers. The apparatus according to claim 47, wherein said stenosis calculating means comprises means for determining a maximum value of the section size value as a non-illness portion of the vascular system and a minimum value of the section size value as an illness portion of the vascular system. The examiner notes that the processor calculates the area and the diameter values of the vessel from the received vessel data and determines the maximum lumen area to define a non-illness region and the minimum lumen area to define an illness region. Thus, the minimum lumen area is calculated using the area values to define a stenosis);
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 (figs. 10-11; claim 34, col 5, lines 15-26, and col 8, line 41 to col 9, line 31; An apparatus for diagnosing a vascular system of an organism having a lumen in which an inner wall is formed therein, the vascular system including a blood vessel, the apparatus comprising: means for fluorographing the vascular system to be diagnosed by X-rays, said X-rays being transmitted through the organism and converted into electrical image signals; means for obtaining, in response to a synchronization signal, fluoroscopic two-dimensional image data in accordance with the image signals supplied by the X-ray fluorographing means; means for probing the vascular system using ultrasonic signals, the ultrasonic probing means having an ultrasonic probe transferrably inserted into the lumen of the vascular system via a catheter incorporating the ultrasonic probe, the ultrasonic probe being able to obtain ultrasonic echoes representing ultrasonic tomographic images of the vascular system, and the ultrasonic echoes being converted into electrical image signals; means for obtaining, in response to the synchronization signal, tomographic two-dimensional image data in accordance with the image signals supplied by the ultrasonic probing means; means for determining a structure of the vascular system in accordance with the fluoroscopic two-dimensional image data and the tomographic two-dimensional image data; means for designating a diameter of the ultrasonic probe; means for calculating an absolute cross-sectional area of the lumen and an absolute diameter of the lumen in accordance with data corresponding to the structure of the vascular system and the diameter of the ultrasonic probe; and means for displaying the structure of the vascular system together with the absolute cross-sectional area of the lumen and the absolute diameter of the lumen. Further, the integrated pixel number in the second frame memory is divided by that in the first frame memory to produce a ratio W.sub.2. The ratio W.sub.2 is then delineated at the second position determined by the transferred distance L.sub.2 in the memory 38. This delineation made such that the diameters W.sub.1 and W.sub.2 are parallel to each other and a center line passes perpendicularly through the diameters W.sub.1 and W.sub.2, as shown in FIG. 10. For all the frame memories, the above calculation and delineation are carried out, hence forming a structure of the diagnosed blood vessel BV as shown in FIG. 10. In FIG. 10, the cross sectional areas of the lumen at the transferred positions are expressed one-dimensionally in each longitudinal direction, but are expressed two-dimensionally in the transverse direction. The examiner notes that based on the diameter and area values calculated from the vessel data, the processor generates a 2D representation of the vessel structure that identifies the absolute diameter and area values and the representation is symmetrical relative to the longest axis of the representation, see figure 10.); 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 configured to identify a location and a value for the MLA with respect to the two- dimensional representation of the vessel (figs. 10-11; claims 34 and 48, col 8, line 41 to col 9, line 31; An apparatus for diagnosing a vascular system of an organism having a lumen in which an inner wall is formed therein, the vascular system including a blood vessel, the apparatus comprising: means for fluorographing the vascular system to be diagnosed by X-rays, said X-rays being transmitted through the organism and converted into electrical image signals; means for obtaining, in response to a synchronization signal, fluoroscopic two-dimensional image data in accordance with the image signals supplied by the X-ray fluorographing means; means for probing the vascular system using ultrasonic signals, the ultrasonic probing means having an ultrasonic probe transferrably inserted into the lumen of the vascular system via a catheter incorporating the ultrasonic probe, the ultrasonic probe being able to obtain ultrasonic echoes representing ultrasonic tomographic images of the vascular system, and the ultrasonic echoes being converted into electrical image signals; means for obtaining, in response to the synchronization signal, tomographic two-dimensional image data in accordance with the image signals supplied by the ultrasonic probing means; means for determining a structure of the vascular system in accordance with the fluoroscopic two-dimensional image data and the tomographic two-dimensional image data; means for designating a diameter of the ultrasonic probe; means for calculating an absolute cross-sectional area of the lumen and an absolute diameter of the lumen in accordance with data corresponding to the structure of the vascular system and the diameter of the ultrasonic probe; and means for displaying the structure of the vascular system together with the absolute cross-sectional area of the lumen and the absolute diameter of the lumen. The apparatus according to claim 37, wherein said transferred position searching means comprises subtraction means for performing a subtraction pixel-by-pixel between a first fluoroscopic two-dimensional image data value and a subsequent fluoroscopic two-dimensional image data value. Moreover, there are provided two types of stenosis indexes, which are both relative values. One is a stenosis index representing the cross sectional area of the lumen and the other a stenosis index representing the diameter of the lumen. The stenosis index SI(area) representing the cross sectional area can be calculated by SI(area)={(MX-MN)/MX}.times.100(%), where MX and MN are maximum and minimum values in all of the integrated pixel numbers. The stenosis index SI(diam.) representing the lumen diameter can be calculated by SI(diam.)={(MX.sup.1/2 -MN.sup.1/2)/MX.sup.1/2 }.times.100 (%) Both of the indexes SI(area) and SI(diam.) are delineated in the graphic memory 38.The stored data in the graphic memory 38 is then supplied, under control of the controller 17, to the X-ray image monitor 15 by way of the D-A converter 39. As a result, the structure of the blood vessel BV is displayed with the two stenosis indexes, as shown in FIG. 11. The image of FIG. 11 can be displayed, either independently of the fluoroscopic X-ray image or superimposedly with it. The structure image shown in FIG. 11 provides a highly concrete figure. The operator can observe easily and understandably the lumen BV.sub.LM, especially its details at each point in the longitudinal direction of the vessel. Therefore, the apparatus here can provide more accurate information, including stenosis indexes, of the blood vessel, compared with the conventional techniques. The examiner notes that the two dimensional representation of the vessel is displayed along with the absolute area and diameter values and an indication of the stenosis location where the minimum lumen area and diameter are located along with a stenosis index representing the minimum cross sectional area of the lumen and the other a stenosis index representing the minimum diameter of the lumen, see figure 11 that shows the vertical line as an indication of the stenosis along with stenosis index values).
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 Asahina because it helps the operator to easily and understandably observe the lumen, especially its details at each point in the longitudinal direction of the vessel. Therefore, it can provide more accurate information, including stenosis indexes, of the blood vessel as disclosed within Asahina in col 9, lines 24-31.
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 configured to identify of a location and value for the MLA with respect to the two-dimensional representation of the vessel.
Asahina, 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 (claim 48, col 5, lines 15-26, and col 8, line 41 to col 9, line 31; The microcomputer 37 is designed to carry out processing of determining dimensions relating to structure of a diagnosed blood vessel and its stenosis index. In order to perform the processing, as preparatory steps, the microcomputer 37 also carries out calculation for determining the inserted position of the ultrasonic probe 21 based on the X-ray fluoroscopic image data and the cross-sectional area of the lumen of the diagnosed blood vessel based on the ultrasonic image data. The thus-determined image data relating to the blood vessel structure and its stenosis index are sent to a graphic memory 38 for composing a picture therein. For all the frame memories, the above calculation and delineation are carried out, hence forming a structure of the diagnosed blood vessel BV as shown in FIG. 10. In FIG. 10, the cross sectional areas of the lumen at the transferred positions are expressed one-dimensionally in each longitudinal direction, but are expressed two-dimensionally in the transverse direction. Moreover, there are provided two types of stenosis indexes, which are both relative values. One is a stenosis index representing the cross sectional area of the lumen and the other a stenosis index representing the diameter of the lumen. The stenosis index SI(area) representing the cross sectional area can be calculated by SI(area)={(MX-MN)/MX}.times.100(%), where MX and MN are maximum and minimum values in all of the integrated pixel numbers. The apparatus according to claim 47, wherein said stenosis calculating means comprises means for determining a maximum value of the section size value as a non-illness portion of the vascular system and a minimum value of the section size value as an illness portion of the vascular system. The examiner notes that the processor calculates the area and the diameter values of the vessel from the received vessel data and determines the maximum lumen area to define a non-illness region and the minimum lumen area to define an illness region. Thus, the minimum lumen area is calculated using the area values to define a stenosis);
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 (figs. 10-11; claim 34, col 5, lines 15-26, and col 8, line 41 to col 9, line 31; An apparatus for diagnosing a vascular system of an organism having a lumen in which an inner wall is formed therein, the vascular system including a blood vessel, the apparatus comprising: means for fluorographing the vascular system to be diagnosed by X-rays, said X-rays being transmitted through the organism and converted into electrical image signals; means for obtaining, in response to a synchronization signal, fluoroscopic two-dimensional image data in accordance with the image signals supplied by the X-ray fluorographing means; means for probing the vascular system using ultrasonic signals, the ultrasonic probing means having an ultrasonic probe transferrably inserted into the lumen of the vascular system via a catheter incorporating the ultrasonic probe, the ultrasonic probe being able to obtain ultrasonic echoes representing ultrasonic tomographic images of the vascular system, and the ultrasonic echoes being converted into electrical image signals; means for obtaining, in response to the synchronization signal, tomographic two-dimensional image data in accordance with the image signals supplied by the ultrasonic probing means; means for determining a structure of the vascular system in accordance with the fluoroscopic two-dimensional image data and the tomographic two-dimensional image data; means for designating a diameter of the ultrasonic probe; means for calculating an absolute cross-sectional area of the lumen and an absolute diameter of the lumen in accordance with data corresponding to the structure of the vascular system and the diameter of the ultrasonic probe; and means for displaying the structure of the vascular system together with the absolute cross-sectional area of the lumen and the absolute diameter of the lumen. Further, the integrated pixel number in the second frame memory is divided by that in the first frame memory to produce a ratio W.sub.2. The ratio W.sub.2 is then delineated at the second position determined by the transferred distance L.sub.2 in the memory 38. This delineation made such that the diameters W.sub.1 and W.sub.2 are parallel to each other and a center line passes perpendicularly through the diameters W.sub.1 and W.sub.2, as shown in FIG. 10. For all the frame memories, the above calculation and delineation are carried out, hence forming a structure of the diagnosed blood vessel BV as shown in FIG. 10. In FIG. 10, the cross sectional areas of the lumen at the transferred positions are expressed one-dimensionally in each longitudinal direction, but are expressed two-dimensionally in the transverse direction. The examiner notes that based on the diameter and area values calculated from the vessel data, the processor generates a 2D representation of the vessel structure that identifies the absolute diameter and area values and the representation is symmetrical relative to the longest axis of the representation, see figure 10.); 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 configured to identify a location and a value for the MLA with respect to the two- dimensional representation of the vessel (figs. 10-11; claims 34 and 48, col 8, line 41 to col 9, line 31; An apparatus for diagnosing a vascular system of an organism having a lumen in which an inner wall is formed therein, the vascular system including a blood vessel, the apparatus comprising: means for fluorographing the vascular system to be diagnosed by X-rays, said X-rays being transmitted through the organism and converted into electrical image signals; means for obtaining, in response to a synchronization signal, fluoroscopic two-dimensional image data in accordance with the image signals supplied by the X-ray fluorographing means; means for probing the vascular system using ultrasonic signals, the ultrasonic probing means having an ultrasonic probe transferrably inserted into the lumen of the vascular system via a catheter incorporating the ultrasonic probe, the ultrasonic probe being able to obtain ultrasonic echoes representing ultrasonic tomographic images of the vascular system, and the ultrasonic echoes being converted into electrical image signals; means for obtaining, in response to the synchronization signal, tomographic two-dimensional image data in accordance with the image signals supplied by the ultrasonic probing means; means for determining a structure of the vascular system in accordance with the fluoroscopic two-dimensional image data and the tomographic two-dimensional image data; means for designating a diameter of the ultrasonic probe; means for calculating an absolute cross-sectional area of the lumen and an absolute diameter of the lumen in accordance with data corresponding to the structure of the vascular system and the diameter of the ultrasonic probe; and means for displaying the structure of the vascular system together with the absolute cross-sectional area of the lumen and the absolute diameter of the lumen. The apparatus according to claim 37, wherein said transferred position searching means comprises subtraction means for performing a subtraction pixel-by-pixel between a first fluoroscopic two-dimensional image data value and a subsequent fluoroscopic two-dimensional image data value. Moreover, there are provided two types of stenosis indexes, which are both relative values. One is a stenosis index representing the cross sectional area of the lumen and the other a stenosis index representing the diameter of the lumen. The stenosis index SI(area) representing the cross sectional area can be calculated by SI(area)={(MX-MN)/MX}.times.100(%), where MX and MN are maximum and minimum values in all of the integrated pixel numbers. The stenosis index SI(diam.) representing the lumen diameter can be calculated by SI(diam.)={(MX.sup.1/2 -MN.sup.1/2)/MX.sup.1/2 }.times.100 (%) Both of the indexes SI(area) and SI(diam.) are delineated in the graphic memory 38.The stored data in the graphic memory 38 is then supplied, under control of the controller 17, to the X-ray image monitor 15 by way of the D-A converter 39. As a result, the structure of the blood vessel BV is displayed with the two stenosis indexes, as shown in FIG. 11. The image of FIG. 11 can be displayed, either independently of the fluoroscopic X-ray image or superimposedly with it. The structure image shown in FIG. 11 provides a highly concrete figure. The operator can observe easily and understandably the lumen BV.sub.LM, especially its details at each point in the longitudinal direction of the vessel. Therefore, the apparatus here can provide more accurate information, including stenosis indexes, of the blood vessel, compared with the conventional techniques. The examiner notes that the two dimensional representation of the vessel is displayed along with the absolute area and diameter values and an indication of the stenosis location where the minimum lumen area and diameter are located along with a stenosis index representing the minimum cross sectional area of the lumen and the other a stenosis index representing the minimum diameter of the lumen, see figure 11 that shows the vertical line as an indication of the stenosis along with stenosis index values).
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 Asahina because it helps the operator to easily and understandably observe the lumen, especially its details at each point in the longitudinal direction of the vessel. Therefore, it can provide more accurate information, including stenosis indexes, of the blood vessel as disclosed within Asahina in col 9, lines 24-31.
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 Asahina et al. (US Patent No. 5,357,550) in further view of Barlis (NPL: “The use of intracoronary optical coherence tomography in interventional cardiology: safety, 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 cross sectional 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 Asahina 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 cross-sectional 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 Asahina 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 cross sectional 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 Asahina 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 with respect to claim(s) 35 USC 103 rejection have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/ZAINAB MOHAMMED ALDARRAJI/Patent Examiner, Art Unit 3797
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