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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/10/2026 has been entered.
Response to Amendment
The proposed reply filed on 03/10/2026 has been entered. Claims 1-20 remain pending in the current application. The amendment to the claims has overcome the 35 USC 112 rejections.
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 1-5, 7-13, and 15-20 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) and Redel et al. (US Pub No. 2007/0135707).
Regarding claim 1, Huennekens teaches a method, comprising:
receiving, by one or more processors, vessel data including image data for a vessel (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, cross-sectional values for at least a portion of the vessel (para. 0071; 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. );
generating, by one or more processors, a two-dimensional representation (para. 0069; the longitudinal IVUS grayscale image and/or the color (Virtual Histology) image)
generating, by the one or more processors based on the vessel data, at least one additional representation of the vessel (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 additional representation of the vessel is the enhanced radiological image, where the longitudinal IVUS image (two-dimensional representation) and the enhanced radiological image are displayed together.);
providing for output, by the one or more processors, the two-dimensional representation of the vessel data and the at least one additional representation of the vessel (paras. 0069-0070; the enhanced radiological, transverse cross-sectional, and longitudinal cross-sectional images can be displayed together. 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 additional representation of the vessel is the enhanced radiological image, where the longitudinal IVUS image (two-dimensional representation) and the enhanced radiological image are displayed together.);
receiving, by the one or more processors, a user input in connection with a first one of the two-dimensional representation of the vessel data or the at least one additional 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);
and updating, by the one or more processors based on the user input received in connection with the first one, a second one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel (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).
However, fails to explicitly teach generating, by the one or more processors based on the cross sectional values, a two-dimensional representation of the vessel, wherein the two-dimensional representation is symmetrical profile representation of the vessel relative to a longest axis of the two-dimensional representation, a first axis of the two-dimensional representation corresponds to mean cross-sectional diameter or cross-sectional area values based on the determined cross-sectional values, and a second axis of the two-dimensional representation corresponds to a position along the vessel; receiving, by the one or more processors, a user input corresponding to a stenting configuration in connection with a first one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel; and updating, by the one or more processors based on the user input received in connection with the first one, a second one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel indicating the stenting configuration.
Zarkh, in the same field of endeavor, teaches generating, by the one or more processors based on the cross sectional values, a two-dimensional representation of the vessel wherein the two-dimensional representation is a symmetrical profile representation of the vessel 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.), a first axis of the two-dimensional representation corresponds to mean cross-sectional diameter or cross-sectional area values based on the determined cross-sectional values, and a second axis of the two-dimensional representation corresponds to a position along the vessel (figure 34, paras. 0111, 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.).
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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 two dimensional representation of the vessel based on cross sectional values taught by Zarkh because it helps provide quantitative analysis of the vessel of interest to accurately determine the extent of stenosis in the vessel (para. 0219).
However, Huennekens in the view of Zarkh fail to explicitly teach receiving, by the one or more processors, a user input corresponding to a stenting configuration in connection with a first one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel; and updating, by the one or more processors based on the user input received in connection with the first one, a second one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel indicating the stenting configuration.
Redel, in the same field of endeavor, teaches receiving, by the one or more processors, a user input corresponding to a stenting configuration in connection with a first one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel (para. 0024; The selection of an actual stent from among the available stents based on the planning analysis result is made in step C. Again, this can proceed manually, with interaction by the physician, or completely automatically within the computer. In the manual embodiment, the physician selects a stent from a stent data base, which can be a list of stents sorted by stent manufacturer, stent type and stent size. This selection is made based on the set of characteristics obtained in step B. The examiner notes that the user selects a stent configuration (size and type) and the processor receives the user selection); and updating, by the one or more processors based on the user input received in connection with the first one, a second one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel indicating the stenting configuration (paras. 0025-0026; After the actual stent has been selected, in step D the computer generates a virtual representation of the selected actual stent. In step E, the optimized deployed position of the actual stent is determined by superimposing the virtual representation of the selected actual stent on the planning image data set. Using pattern recognition and image processing software, the computer can identify the best position of the computer model (virtual representation) of the selected stent within the reconstructed image. This analysis takes into account the degree of shrinkage of the stent that can be expected during stent expansion. If the characteristics obtained in the stenosis analysis include information such as tissue composition and/or vessel wall elasticity, this information can also be included in the simulation. The examiner notes that the planning image data gets updated based on the user selection by superimposing the virtual stent at an optimal location in the vessel).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the user input of Huennekens in the view of Zarkh with the user input corresponding to a stenting configuration taught by Redel because it provides computerized support, for planning a stenting procedure to treat a lumen afflicted with a lesion in the body of a patient, including selection of the most appropriate stent for the procedure and optimal position, as well as for conducting the stenting procedure itself as disclosed within Redel in para. 0011.
Regarding claim 2, Huennekens teaches the method of claim 1, wherein the image data includes at least one of optical coherence tomography (OCT) image data or angiography image data (para. 0010; Several types of catheter systems have been designed to track through a vasculature to image atherosclerotic plaque deposits on vessel walls. These advanced imaging modalities include, but are not limited to, intravascular ultrasound (IVUS) catheters, magnetic resonance imaging (MRI) catheters and optical coherence tomography (OCT) catheters.).
Regarding claim 3, Huennekens teaches the method of claim 1, however, fails to explicitly teach wherein the two-dimensional representation includes an indication of the mean cross-sectional diameter values or cross-sectional area values for the at least a portion of the vessel.
Zarkh, in the same field of endeavor, teaches wherein the two-dimensional representation includes an indication of the mean cross-sectional diameter values or cross-sectional area values for the at least a portion of the vessel (figure 34, paras. 0111, 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.).
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 two dimensional representation that includes an indication of the mean cross-sectional diameter values or cross-sectional area values taught by Zarkh because it helps provide quantitative analysis of the vessel of interest to accurately determine the extent of stenosis in the vessel (para. 0219).
Regarding claim 4, Huennekens teaches the method of claim 1, wherein the at least one additional representation of the vessel comprises an intravascular image (para. 0076; the image data comprises an IVUS image generated by an ultrasound transducer probe mounted upon the imaging catheter 20.).
Regarding claim 5, Huennekens teaches the method of claim 1, wherein the at least one additional representation of the vessel comprises an angiography image (para. 0074; an angiogram image is generated and stored within the first portion 36 of image data memory 40.).
Regarding claim 7, Huennekens teaches the method of claim 1, further comprising: determining, by the one or more processors based on the vessel data, a lumen area from a set of area values calculated at positions along 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.); and providing for output, by the one or more processors, an indication of a value of the determined lumen area relative to the two-dimensional representation (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.).
However, Huennekens fail to explicitly teach that the lumen area is a minimum lumen area.
Zarkh, in the same field of endeavor, teaches displaying a minimum lumen area relative to a 2D representation (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. The examiner notes that the upper graph of figure 34 represent a longitudinal representation of the vessel with MLA values displayed relative to the two-dimensional representation.).
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 displaying a minimum lumen area relative to a 2D representation taught by Zarkh because it helps provide quantitative analysis of the vessel of interest (para. 0219).
Regarding claim 8, Huennekens teaches the method of claim 1, wherein updating the second one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel further comprises: identifying, by the one or more processors based on the user input identifying a region received in connection with the first one, 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 mean cross-sectional diameter value associated with the selected image frame relative to at least one of the two-dimensional representation or the at least one additional representation (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. The examiner notes that the diameter obtained in Huennekens is the diameter of cross-section of the vessel.).
Regarding claim 9, 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 (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, cross-sectional values for at least a portion of the vessel (para. 0071; 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. );
generate a two-dimensional representation (para. 0069; the longitudinal IVUS grayscale image and/or the color (Virtual Histology) image)
generate, based on the vessel data, at least one additional representation of the vessel (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 additional representation of the vessel is the enhanced radiological image, where the longitudinal IVUS image (two-dimensional representation) and the enhanced radiological image are displayed together.);
provide for output, by the one or more processors, the two-dimensional representation of the vessel data and the at least one additional representation of the vessel (paras. 0069-0070; the enhanced radiological, transverse cross-sectional, and longitudinal cross-sectional images can be displayed together. 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 additional representation of the vessel is the enhanced radiological image, where the longitudinal IVUS image (two-dimensional representation) and the enhanced radiological image are displayed together.);
receive, by the one or more processors, a user input in connection with a first one of the two-dimensional representation of the vessel data or the at least one additional 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);
and update, by the one or more processors based on the user input received in connection with the first one, a second one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel (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).
However, fails to explicitly teach generate, by the one or more processors based on the cross sectional values, a two-dimensional representation of the vessel, wherein the two-dimensional representation is symmetrical profile representation of the vessel relative to a longest axis of the two-dimensional representation, a first axis of the two-dimensional representation corresponds to mean cross-sectional diameter or cross-sectional area values based on the determined cross-sectional values, and a second axis of the two-dimensional representation corresponds to a position along the vessel; receive, by the one or more processors, a user input corresponding to a stenting configuration in connection with a first one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel; and update, by the one or more processors based on the user input received in connection with the first one, a second one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel indicating the stenting configuration.
Zarkh, in the same field of endeavor, teaches generate, by the one or more processors based on the cross sectional values, a two-dimensional representation of the vessel wherein the two-dimensional representation is symmetrical profile representation of the vessel 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 above.), a first axis of the two-dimensional representation corresponds to mean cross-sectional diameter or cross-sectional area values based on the determined cross-sectional values, and a second axis of the two-dimensional representation corresponds to a position along the vessel (figure 34, paras. 0111, 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.).
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 two dimensional representation of the vessel based on cross sectional values taught by Zarkh because it helps provide quantitative analysis of the vessel of interest to accurately determine the extent of stenosis in the vessel (para. 0219).
However, Huennekens in the view of Zarkh fail to explicitly teach receive, by the one or more processors, a user input corresponding to a stenting configuration in connection with a first one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel; and update, by the one or more processors based on the user input received in connection with the first one, a second one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel indicating the stenting configuration.
Redel, in the same field of endeavor, teaches receive, by the one or more processors, a user input corresponding to a stenting configuration in connection with a first one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel (para. 0024; The selection of an actual stent from among the available stents based on the planning analysis result is made in step C. Again, this can proceed manually, with interaction by the physician, or completely automatically within the computer. In the manual embodiment, the physician selects a stent from a stent data base, which can be a list of stents sorted by stent manufacturer, stent type and stent size. This selection is made based on the set of characteristics obtained in step B. The examiner notes that the user selects a stent configuration (size and type) and the processor receives the user selection); and update, by the one or more processors based on the user input received in connection with the first one, a second one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel indicating the stenting configuration (paras. 0025-0026; After the actual stent has been selected, in step D the computer generates a virtual representation of the selected actual stent. In step E, the optimized deployed position of the actual stent is determined by superimposing the virtual representation of the selected actual stent on the planning image data set. Using pattern recognition and image processing software, the computer can identify the best position of the computer model (virtual representation) of the selected stent within the reconstructed image. This analysis takes into account the degree of shrinkage of the stent that can be expected during stent expansion. If the characteristics obtained in the stenosis analysis include information such as tissue composition and/or vessel wall elasticity, this information can also be included in the simulation. The examiner notes that the planning image data gets updated based on the user selection by superimposing the virtual stent at an optimal location in the vessel).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the user input of Huennekens in the view of Zarkh with the user input corresponding to a stenting configuration taught by Redel because it provides computerized support, for planning a stenting procedure to treat a lumen afflicted with a lesion in the body of a patient, including selection of the most appropriate stent for the procedure and optimal position, as well as for conducting the stenting procedure itself as disclosed within Redel in para. 0011.
Regarding claim 10, Huennekens teaches the system of claim 9, wherein the image data includes at least one of optical coherence tomography (OCT) image data or angiography image data (para. 0010; Several types of catheter systems have been designed to track through a vasculature to image atherosclerotic plaque deposits on vessel walls. These advanced imaging modalities include, but are not limited to, intravascular ultrasound (IVUS) catheters, magnetic resonance imaging (MRI) catheters and optical coherence tomography (OCT) catheters.).
Regarding claim 11, Huennekens teaches the system of claim 9, however, fails to explicitly teach wherein the wherein the two-dimensional representation includes an indication of the mean cross-sectional diameter values or cross-sectional area values for the at least a portion of the vessel.
Zarkh, in the same field of endeavor, teaches wherein the two-dimensional representation includes an indication of the mean cross-sectional diameter values or cross-sectional area values for the at least a portion of the vessel (figure 34, paras. 0111, 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.).
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 two dimensional representation that includes an indication of the mean cross-sectional diameter values or cross-sectional area values taught by Zarkh because it helps provide quantitative analysis of the vessel of interest to accurately determine the extent of stenosis in the vessel (para. 0219).
Regarding claim 12, Huennekens teaches the system of claim 9, wherein the at least one additional representation of the vessel comprises an intravascular image (para. 0076; the image data comprises an IVUS image generated by an ultrasound transducer probe mounted upon the imaging catheter 20.).
Regarding claim 13, Huennekens teaches the system of claim 9, wherein the at least one additional representation of the vessel comprises an angiography image (para. 0074; an angiogram image is generated and stored within the first portion 36 of image data memory 40.).
Regarding claim 15, Huennekens teaches the system of claim 9, further comprising: determine, by the one or more processors based on the vessel data, a lumen area from a set of area values calculated at positions along 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.); and providing for output, by the one or more processors, an indication of a value of the determined lumen area relative to the two-dimensional representation (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.).
However, Huennekens fail to explicitly teach that the lumen area is a minimum lumen area.
Zarkh, in the same field of endeavor, teaches display a minimum lumen area relative to a 2D representation (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. The examiner notes that the upper graph of figure 34 represent a longitudinal representation of the vessel with MLA values displayed relative to the two-dimensional representation.).
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 displaying a minimum lumen area relative to a 2D representation taught by Zarkh because it helps provide quantitative analysis of the vessel of interest (para. 0219).
Regarding claim 16, Huennekens teaches the system of claim 9, wherein when updating the second one of the two- dimensional representation of the vessel data or the at least one additional representation of the vessel the one or more processors are further configured to: identify, based on the user input identifying a region received in connection with the first one, 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 provide for output the mean cross-sectional diameter value associated with the selected image frame relative to at least one of the two-dimensional representation or the at least one additional representation (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. The examiner notes that the diameter obtained in Huennekens is the diameter of cross-section of the vessel.).
Regarding claim 17, 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 (para. 0043):
receive vessel data including image data for a vessel (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, cross-sectional values for at least a portion of the vessel (para. 0071; 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. );
generate a two-dimensional representation (para. 0069; the longitudinal IVUS grayscale image and/or the color (Virtual Histology) image)
generate, based on the vessel data, at least one additional representation of the vessel (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 additional representation of the vessel is the enhanced radiological image, where the longitudinal IVUS image (two dimensional representation) and the enhanced radiological image are displayed together.);
provide for output the two-dimensional representation of the vessel data and the at least one additional representation of the vessel (paras. 0069-0070; the enhanced radiological, transverse cross-sectional, and longitudinal cross-sectional images can be displayed together. 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 additional representation of the vessel is the enhanced radiological image, where the longitudinal IVUS image (two-dimensional representation) and the enhanced radiological image are displayed together.);
receive a user input in connection with a first one of the two-dimensional representation of the vessel data or the at least one additional 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);
and update, based on the user input received in connection with the first one, a second one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel (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).
However, fails to explicitly teach generate, based on the cross sectional values, a two-dimensional representation of the vessel, wherein the two-dimensional representation is symmetrical profile representation of the vessel relative to a longest axis of the two-dimensional representation, a first axis of the two-dimensional representation corresponds to mean cross-sectional diameter or cross-sectional area values based on the determined cross-sectional values, and a second axis of the two-dimensional representation corresponds to a position along the vessel; receive, a user input corresponding to a stenting configuration in connection with a first one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel; and update, based on the user input received in connection with the first one, a second one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel indicating the stenting configuration.
Zarkh, in the same field of endeavor, teaches generate, based on the cross sectional values, a two-dimensional representation of the vessel wherein the two-dimensional representation is symmetrical profile representation of the vessel 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 above.), a first axis of the two-dimensional representation corresponds to mean cross-sectional diameter or cross-sectional area values based on the determined cross-sectional values, and a second axis of the two-dimensional representation corresponds to a position along the vessel (figure 34, paras. 0111, 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.).
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 two dimensional representation of the vessel based on cross sectional values taught by Zarkh because it helps provide quantitative analysis of the vessel of interest to accurately determine the extent of stenosis in the vessel (para. 0219).
However, Huennekens in the view of Zarkh fail to explicitly teach receive a user input corresponding to a stenting configuration in connection with a first one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel; and update based on the user input received in connection with the first one, a second one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel indicating the stenting configuration.
Redel, in the same field of endeavor, teaches receive, a user input corresponding to a stenting configuration in connection with a first one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel (para. 0024; The selection of an actual stent from among the available stents based on the planning analysis result is made in step C. Again, this can proceed manually, with interaction by the physician, or completely automatically within the computer. In the manual embodiment, the physician selects a stent from a stent data base, which can be a list of stents sorted by stent manufacturer, stent type and stent size. This selection is made based on the set of characteristics obtained in step B. The examiner notes that the user selects a stent configuration (size and type) and the processor receives the user selection); and update, based on the user input received in connection with the first one, a second one of the two-dimensional representation of the vessel data or the at least one additional representation of the vessel indicating the stenting configuration (paras. 0025-0026; After the actual stent has been selected, in step D the computer generates a virtual representation of the selected actual stent. In step E, the optimized deployed position of the actual stent is determined by superimposing the virtual representation of the selected actual stent on the planning image data set. Using pattern recognition and image processing software, the computer can identify the best position of the computer model (virtual representation) of the selected stent within the reconstructed image. This analysis takes into account the degree of shrinkage of the stent that can be expected during stent expansion. If the characteristics obtained in the stenosis analysis include information such as tissue composition and/or vessel wall elasticity, this information can also be included in the simulation. The examiner notes that the planning image data gets updated based on the user selection by superimposing the virtual stent at an optimal location in the vessel).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the user input of Huennekens in the view of Zarkh with the user input corresponding to a stenting configuration taught by Redel because it provides computerized support, for planning a stenting procedure to treat a lumen afflicted with a lesion in the body of a patient, including selection of the most appropriate stent for the procedure and optimal position, as well as for conducting the stenting procedure itself as disclosed within Redel in para. 0011.
Regarding claim 18, Huennekens teaches the one or more non-transitory computer-readable medium of claim 17, wherein the image data includes at least one of optical coherence tomography (OCT) image data or angiography image data (para. 0010; Several types of catheter systems have been designed to track through a vasculature to image atherosclerotic plaque deposits on vessel walls. These advanced imaging modalities include, but are not limited to, intravascular ultrasound (IVUS) catheters, magnetic resonance imaging (MRI) catheters and optical coherence tomography (OCT) catheters.).
Regarding claim 19, Huennekens teaches the one or more non-transitory computer-readable medium of claim 15, however, fails to explicitly teach wherein the two-dimensional representation includes an indication of the mean cross-sectional diameter values for the at least a portion of the vessel.
Zarkh, in the same field of endeavor, teaches wherein the two-dimensional representation includes an indication of the mean cross-sectional diameter values or cross-sectional area values for the at least a portion of the vessel (figure 34, paras. 0111, 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.).
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 two dimensional representation that includes an indication of the mean cross-sectional diameter values or cross-sectional area values taught by Zarkh because it helps provide quantitative analysis of the vessel of interest to accurately determine the extent of stenosis in the vessel (para. 0219).
Regarding claim 20, Huennekens teaches the one or more non-transitory computer-readable medium of claim 15, wherein the at least one additional representation of the vessel comprises an intravascular image or an angiography image (para. 0076; the image data comprises an IVUS image generated by an ultrasound transducer probe mounted upon the imaging catheter 20.).
Claims 6 and 14 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) and Redel et al. (US Pub No. 2007/0135707) and in further view of Xu (US Pub No. 2010/0094127).
Regarding claim 6, Huennekens teaches the method of claim 1, however fails to explicitly teach identifying, by the one or more processors based on the vessel data, one or more regions of stent malapposition; and providing for output, by the one or more processors, an indication of the identified one or more regions of stent malposition relative to the two-dimensional representation of the vessel.
Xu, in the same field of endeavor, teaches identifying, by the one or more processors based on the vessel data, one or more regions of stent malposition (para. 0050; Once the stent location and the lumen boundary have been determined, stent malposition, coverage and restenosis measurements are made (Step 28). Finally, the images and measurements are visualized and displayed (Step 32).); and providing for output, by the one or more processors, an indication of the identified one or more regions of stent malapposition relative to the two-dimensional representation of the vessel (para. 0050; Once the stent location and the lumen boundary have been determined, stent malapposition, coverage and restenosis measurements are made (Step 28). Finally, the images and measurements are visualized and displayed (Step 32).).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and device of Huennekens in the view of Zarkh and Redel to include a step of identifying, based on the vessel data, one or more regions of stent malapposition taught by Xu because it helps provide important information on whether stent failed (see para. 0006).
Regarding claim 14, Huennekens teaches the system of claim 9, however fails to explicitly teach identifying, based on the vessel data, one or more regions of stent malapposition; and providing for output, an indication of the identified one or more regions of stent malapposition relative to the two-dimensional representation of the vessel.
Xu, in the same field of endeavor, teaches identifying, based on the vessel data, one or more regions of stent malapposition (para. 0050; Once the stent location and the lumen boundary have been determined, stent malapposition, coverage and restenosis measurements are made (Step 28). Finally, the images and measurements are visualized and displayed (Step 32).); and providing for output an indication of the identified one or more regions of stent malapposition relative to the two-dimensional representation of the vessel (para. 0050; Once the stent location and the lumen boundary have been determined, stent malapposition, coverage and restenosis measurements are made (Step 28). Finally, the images and measurements are visualized and displayed (Step 32).).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and device of Huennekens in the view of Zarkh and Redel to include a step of identifying, based on the vessel data, one or more regions of stent malapposition taught by Xu because it helps provide important information on whether stent failed (see para. 0006).
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 “generating, by the one or more processors based on the cross-sectional values, a two- dimensional representation of the vessel, wherein: the two-dimensional representation is a symmetrical profile representation of the vessel 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
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