Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
1. This action is responsive to communications: Application filed on December 1, 2023, and Drawings filed on December 1, 2023.
2. Claims 1–48 are pending in this case. Claims 1, 17, 33 are independent claims.
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 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.
Allowable Subject Matter
Claims 3-8, 19-24, 35-40 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
With regard to claim 3 and 19 and 35 the prior arts do not disclose the method of claim 2, wherein: performing the medial axis skeletonization comprises, for each pixel corresponding to a vessel, drawing, at the computer, a query circle around the pixel and determining, at the computer, whether the query circle intersects one or more pixels that do not correspond to a vessel.
Claim Rejections - 35 U.S.C. § 101
35 U.S.C. § 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 9, 11, 17, 18, 25, 27, 33, 34, 41, 43 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to an abstract idea without significantly more.
As to claim 1:
Step 1 Analysis: Is the claim to a process, machine, manufacture or composition of matter? See MPEP § 2106.03.
Yes, the claim is to a process.
Step 2A Prong One Analysis: Does the claim recite an abstract idea, law of nature, or natural phenomenon? See MPEP § 2106.04(II)(A)(1).
Yes, the limitation “identifying pixels corresponding to a vessel of a body in the at least one angiographic image frame” is the abstract idea of a mental process that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper (including an observation, evaluation, judgment, opinion). See MPEP § 2106.04(a)(2)(III).
Yes, the limitation “determining a medial axis of the vessel;” is the abstract idea of a mental process that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper (including an observation, evaluation, judgment, opinion). See MPEP § 2106.04(a)(2)(III).
Yes, the limitation “determining a diameter of the vessel in the at least one angiographic image frame by counting pixels corresponding to the vessel in a direction transverse to the medial axis of the vessel.” is the abstract idea of a mental process that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper (including an observation, evaluation, judgment, opinion). See MPEP § 2106.04(a)(2)(III).
Step 2A Prong Two Analysis: Does the claim recite additional elements that integrate the judicial exception into a practical application? See MPEP § 2106.04(d).
No, the limitation “obtaining, at a computer, at least one angiographic image frame;” is an additional element that amounts to adding insignificant extra-solution activity to the judicial exception. See MPEP §§ 2106.04(d), 2106.05(g).
No, the limitation “identifying, at the computer, pixels corresponding to a vessel of a body in the at least one angiographic image frame” is an additional element that amounts to adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer. See MPEP §§ 2106.04(d), 2106.05(f)(1).
No, the limitation “identifying, at the computer, pixels corresponding to a vessel of a body in the at least one angiographic image frame;” is an additional element that amounts to adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer. See MPEP §§ 2106.04(d), 2106.05(f)(1).
No, the limitation “and determining, at the computer, a diameter of the vessel in the at least one angiographic image frame by counting pixels corresponding to the vessel in a direction transverse to the medial axis of the vessel.” is an additional element that amounts to adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer. See MPEP §§ 2106.04(d), 2106.05(f)(1).
Step 2B Analysis: Does the claim recite additional elements that amount to significantly more than the judicial exception? See MPEP § 2106.05.
No, the limitation “obtaining, at a computer, at least one angiographic image frame;” is an additional element that amounts to adding insignificant extra-solution activity to the judicial exception. See MPEP §§ 2106.04(d), 2106.05(g). (“The collecting step is recited at a high level of generality (i.e., as a general means of gathering network traffic data for use in the comparison step), and amounts to mere data gathering, which is a form of insignificant extra-solution activity.”).
No, the limitation “identifying, at the computer, pixels corresponding to a vessel of a body in the at least one angiographic image frame” is an additional element that amounts to adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer. See MPEP §§ 2106.04(d), 2106.05(f)(1).
No, the limitation “identifying, at the computer, pixels corresponding to a vessel of a body in the at least one angiographic image frame;” is an additional element that amounts to adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer. See MPEP §§ 2106.04(d), 2106.05(f)(1).
No, the limitation “and determining, at the computer, a diameter of the vessel in the at least one angiographic image frame by counting pixels corresponding to the vessel in a direction transverse to the medial axis of the vessel.” is an additional element that amounts to adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer. See MPEP §§ 2106.04(d), 2106.05(f)(1).
As to claim 2:
Step 1 Analysis: Is the claim to a process, machine, manufacture or composition of matter? See MPEP § 2106.03.
Yes, the claim is to a process.
Step 2A Prong One Analysis: Does the claim recite an abstract idea, law of nature, or natural phenomenon? See MPEP § 2106.04(II)(A)(1).
Yes, the limitation “wherein determining a medial axis of the vessel comprises performing a medial axis skeletonization of the pixels corresponding to the vessel.” is the abstract idea of a mental process that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper (including an observation, evaluation, judgment, opinion). See MPEP § 2106.04(a)(2)(III).
Step 2A Prong Two Analysis: Does the claim recite additional elements that integrate the judicial exception into a practical application? See MPEP § 2106.04(d).
No, the limitation “wherein determining a medial axis of the vessel comprises performing, at the computer, a medial axis skeletonization of the pixels corresponding to the vessel.” is an additional element that amounts to adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer. See MPEP §§ 2106.04(d), 2106.05(f)(1).data gathering, which is a form of insignificant extra-solution activity.”).
Step 2B Analysis: Does the claim recite additional elements that amount to significantly more than the judicial exception? See MPEP § 2106.05.
No, the limitation “wherein determining a medial axis of the vessel comprises performing, at the computer, a medial axis skeletonization of the pixels corresponding to the vessel.” is an additional element that amounts to adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer. See MPEP §§ 2106.04(d), 2106.05(f)(1).
As to claim 9:
Step 1 Analysis: Is the claim to a process, machine, manufacture or composition of matter? See MPEP § 2106.03.
Yes, the claim is to a process.
Step 2A Prong One Analysis: Does the claim recite an abstract idea, law of nature, or natural phenomenon? See MPEP § 2106.04(II)(A)(1).
Yes, the limitation “converting the diameter of the vessel in pixels to a diameter in size units.” is the abstract idea of a mental process that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper (including an observation, evaluation, judgment, opinion). See MPEP § 2106.04(a)(2)(III).
Step 2A Prong Two Analysis: Does the claim recite additional elements that integrate the judicial exception into a practical application? See MPEP § 2106.04(d).
No, the limitation “converting, at the computer, the diameter of the vessel in pixels to a diameter in size units.” is an additional element that amounts to adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer. See MPEP §§ 2106.04(d), 2106.05(f)(1).
Step 2B Analysis: Does the claim recite additional elements that amount to significantly more than the judicial exception? See MPEP § 2106.05.
No, the limitation “converting, at the computer, the diameter of the vessel in pixels to a diameter in size units.” is an additional element that amounts to adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer. See MPEP §§ 2106.04(d), 2106.05(f)(1).
As to claim 11:
Step 1 Analysis: Is the claim to a process, machine, manufacture or composition of matter? See MPEP § 2106.03.
Yes, the claim is to a process.
Step 2A Prong One Analysis: Does the claim recite an abstract idea, law of nature, or natural phenomenon? See MPEP § 2106.04(II)(A)(1).
Yes, the limitation “detecting a stenosis in the vessel.” is the abstract idea of a mental process that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper (including an observation, evaluation, judgment, opinion). See MPEP § 2106.04(a)(2)(III).
Step 2A Prong Two Analysis: Does the claim recite additional elements that integrate the judicial exception into a practical application? See MPEP § 2106.04(d).
No, the limitation “detecting, at the computer, a stenosis in the vessel.” is an additional element that amounts to adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer. See MPEP §§ 2106.04(d), 2106.05(f)(1).
Step 2B Analysis: Does the claim recite additional elements that amount to significantly more than the judicial exception? See MPEP § 2106.05.
No, the limitation “detecting, at the computer, a stenosis in the vessel.” is an additional element that amounts to adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer. See MPEP §§ 2106.04(d), 2106.05(f)(1).
Claims 17, 18, 25, 27 are the system claims and is rejected for the same reason as claims 1, 2, 9, 11.
Claim 33, 34, 41, 43 is the media claim and is rejected for the same reason as claim 1, 2, 9, 11.
Claim Rejections - 35 USC § 102
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 17, 33 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Oyagi, Pub. No.: 2019/0090732A1.
With regard to claim 1:
Oyagi discloses a method comprising: obtaining, at a computer, at least one angiographic image frame (the angiographic image frame includes three paragraph dimensional angiographic image, data, paragraph 34: “The registration processor 41 performs registration between the first angiographic image data and the second angiographic image data from among the plurality of pieces of angiographic image data stored in the storage 20. In the present example, angiographic image data is typically three dimensional angiographic image data or rendered image data constructed from the three dimensional angiographic image data.”); identifying, at the computer, pixels corresponding to a vessel of a body in the at least one angiographic image frame (calculating the width of the blood vessel (blood vessel diameter) in a direction perpendicular to the blood vessel axis line based on the number of pixels, paragraph 47 to 49: “The blood flow change map can also be generated by determining a blood flow parameter map from the first angiographic image data and another blood flow parameter map from the second angiographic image data, and by calculating the difference between blood flow parameters at corresponding pixel positions of the blood flow parameter maps. In another example, the information generation processor 43 can generate information indicating changes in blood vessel diameters (blood vessel diameter change information) in the fundus of the subject's eye, based on the difference data generated by the difference processor 42. The calculation of a blood vessel diameter includes, for example, a process of determining a blood vessel axis line by applying thinning to a blood vessel image, and a process of calculating the width of the blood vessel (blood vessel diameter) in a direction perpendicular to the blood vessel axis line based on the number of pixels.”); determining, at the computer, a medial axis of the vessel (determining a blood vessel axis line by applying thinning to a blood vessel image, paragraph 47 to 49: “The blood flow change map can also be generated by determining a blood flow parameter map from the first angiographic image data and another blood flow parameter map from the second angiographic image data, and by calculating the difference between blood flow parameters at corresponding pixel positions of the blood flow parameter maps. In another example, the information generation processor 43 can generate information indicating changes in blood vessel diameters (blood vessel diameter change information) in the fundus of the subject's eye, based on the difference data generated by the difference processor 42. The calculation of a blood vessel diameter includes, for example, a process of determining a blood vessel axis line by applying thinning to a blood vessel image, and a process of calculating the width of the blood vessel (blood vessel diameter) in a direction perpendicular to the blood vessel axis line based on the number of pixels.”); and determining, at the computer, a diameter of the vessel in the at least one angiographic image frame by counting pixels corresponding to the vessel in a direction transverse to the medial axis of the vessel (The calculation of a blood vessel diameter includes, for example, a process of determining a blood vessel axis line by applying thinning to a blood vessel image, paragraph 47 to 49: “The blood flow change map can also be generated by determining a blood flow parameter map from the first angiographic image data and another blood flow parameter map from the second angiographic image data, and by calculating the difference between blood flow parameters at corresponding pixel positions of the blood flow parameter maps. In another example, the information generation processor 43 can generate information indicating changes in blood vessel diameters (blood vessel diameter change information) in the fundus of the subject's eye, based on the difference data generated by the difference processor 42. The calculation of a blood vessel diameter includes, for example, a process of determining a blood vessel axis line by applying thinning to a blood vessel image, and a process of calculating the width of the blood vessel (blood vessel diameter) in a direction perpendicular to the blood vessel axis line based on the number of pixels.”).
Claim 17 is the system claim and is rejected for the same reason as claim 1.
Claim 33 is the system claim and is rejected for the same reason as claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2 and 18 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oyagi, in view of Baruch et al., Pub. No.: WO 2021117043 A1.
With regard to claims 2 and 18 and 34:
Oyagi does not disclose the method of claim 1, wherein determining a medial axis of the vessel comprises performing, at the computer, a medial axis skeletonization of the pixels corresponding to the vessel.
However Baruch discloses the aspect wherein determining a medial axis of the vessel comprises performing, at the computer, a medial axis skeletonization of the pixels corresponding to the vessel (paragraph 47: “Determining a centerline as well as calculating distances D1 and D2 can be done by using known algorithms for medial axis skeletonization, for example, scikit-image algorithms. [0048] In some embodiments the 2D image (from which a vessels mask can be obtained) is an optimal image, selected from a plurality of 2D images of the patient’s vessels, as the image showing the most detail. In the case of angiogram images, which include contrast agent injected to a patient to make vessels (e.g., blood vessels) visible on an X-ray image, an optimal image may be an image of a blood vessel showing a large/maximum amount of contrast agent. Thus, an optimal image can be detected by applying image analysis algorithms (e.g., to detect the image frames having the most colored pixels) on a sequence of images.”). It would have been obvious to one of ordinary skill in the art, at the time the filing was made to apply Baruch to Oyagi so the system would be able to accurately identify medial axis and provide correct measurements of the diameter of the vessel using medial axis skeletonization.
Claims 9 and 25 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oyagi, in view of Hoffman, WO2021180501A1.
With regard to claims 9 and 25 and 41:
Oyagi does not disclose the method of claim 1, further comprising converting, at the computer, the diameter of the vessel in pixels to a diameter in size units.
However Hoffman discloses the aspect comprising converting, at the computer, the diameter of the vessel in pixels to a diameter in size units. (paragraph 60: “In an example, the diameter or area of a vessel is determined using image recognition to identify and locate the outer border of the vessel wall. The diameter may be determined in pixels. In some embodiments, the diameter or area of the vessel may be converted to units of distance based on, for example, a conversion between pixels and millimeters or square millimeters being a linear function of the FOV setting (e.g., in millimeters) of the intraluminal imaging system 100. Because vessel diameter or area is being calculated purely for scaling purposes, and not for clinical decision making such as stent sizing, the calculation can be approximate (e.g., with an allowable error of ± 20% or even ± 33%), and thus can benefit from fast, simple recognition and calculation algorithms that run in real time, as well as slower, more accurate recognition and calculation algorithms that may run in near real time, or that may run in the background to determine automatic scaling values for each image in review mode, after the pullback is complete.”). It would have been obvious to one of ordinary skill in the art, at the time the filing was made to apply Hoffman to Oyagi so the system can provide the measurement of diameter in scientific units that can be stored and used broadly.
Claims 10 and 26 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oyagi, in view of Hirokawa, Pub. No.: 20210133955 A1.
With regard to claims 10 and 26 and 42:
Oyagi does not disclose the method of claim 1, further comprising rendering, at the computer, a colored map of the vessel in which a color and hue of the vessel corresponds to a diameter of the vessel.
However Hirokawa discloses the aspect further comprising rendering, at the computer, a colored map of the vessel in which a color and hue of the vessel corresponds to a diameter of the vessel. (paragraph 151: “The icon 842 is an icon for the user to instruct all choroidal blood vessels to be displayed in the vascular image display field 834. When the icon 842 is operated, all choroidal blood vessels are displayed in colors corresponding to their respective blood vessel diameters.”). It would have been obvious to one of ordinary skill in the art, at the time the filing was made to apply Hirokawa to Oyagi so the user can see using color and hue the attribute of the vessel diameters at different sections to be more informed about the patient’s vessel and possible problems.
Claims 11, 12, 13, 14, 15, 16, 27, 28, 29, 30, 31, 32, 43, 44, 45, 46, 47, 48is/are rejected under 35 U.S.C. 103 as being unpatentable over Oyagi, in view of Anderson, 20200289076 A1
With regard to claims 11 and 27 and 43:
Oyagi does not disclose the method of claim 1, further comprising detecting, at the computer, a stenosis in the vessel.
However Anderson discloses the aspect further comprising detecting, at the computer, a stenosis in the vessel (paragraph 53 and 54: “Referring more particularly to FIG. 2, the lumen 106 of the vessel 100 has a diameter 110 proximal of the stenosis 108 and a diameter 112 distal of the stenosis. In some instances, the diameters 110 and 112 are substantially equal to one another. In that regard, the diameters 110 and 112 are intended to represent healthy portions, or at least healthier portions, of the lumen 106 in comparison to stenosis 108. Accordingly, these healthier portions of the lumen 106 are illustrated as having a substantially constant cylindrical profile and, as a result, the height or width of the lumen has been referred to as a diameter. However, it is understood that in many instances these portions of the lumen 106 will also have plaque buildup, a non-symmetric profile, and/or other irregularities, but to a lesser extent than stenosis 108 and, therefore, will not have a cylindrical profile. In such instances, the diameters 110 and 112 are understood to be representative of a relative size or cross-sectional area of the lumen and do not imply a circular cross-sectional profile. As shown in FIG. 2, stenosis 108 includes plaque buildup 114 that narrows the lumen 106 of the vessel 100. In some instances, the plaque buildup 114 does not have a uniform or symmetrical profile, making angiographic evaluation of such a stenosis unreliable. In the illustrated embodiment, the plaque buildup 114 includes an upper portion 116 and an opposing lower portion 118. In that regard, the lower portion 118 has an increased thickness relative to the upper portion 116 that results in a non-symmetrical and non-uniform profile relative to the portions of the lumen proximal and distal of the stenosis 108. As shown, the plaque buildup 114 decreases the available space for fluid to flow through the lumen 106. In particular, the cross-sectional area of the lumen 106 is decreased by the plaque buildup 114. At the narrowest point between the upper and lower portions 116, 118 the lumen 106 has a height 120, which is representative of a reduced size or cross-sectional area relative to the diameters 110 and 112 proximal and distal of the stenosis 108. Note that the stenosis 108, including plaque buildup 114 is exemplary in nature and should be considered limiting in any way. In that regard, it is understood that the stenosis 108 has other shapes and/or compositions that limit the flow of fluid through the lumen 106 in other instances. While the vessel 100 is illustrated in FIGS. 1 and 2 as having a single stenosis 108 and the description of the embodiments below is primarily made in the context of a single stenosis, it is nevertheless understood that the devices, systems, and methods described herein have similar application for a vessel having multiple stenosis regions.”). It would have been obvious to one of ordinary skill in the art, at the time the filing was made to apply Anderson to Oyagi so the system can use pixel size to determine the diameter of the vessel and use the diameter to accurately determine whether the subject has a stenosis in the vessel and treat the subject based on the determination.
With regard to claims 12 and 28 and 44:
Oyagi and Anderson disclose the method of claim 11, further comprising generating, at the computer, a graphical user interface displaying at least one stent in combination with an image of the vessel (Anderson paragraph 99: “The screen display 700 additionally includes an insert stent field 716. Selection of the insert stent field 716 can be a user input to modify the visual representation of the vessel and/or a visualization based on the pressure measurements. In some embodiments, selection of the insert stent field 716 can cause a computing device (e.g., computing device 172) to determine one or more recommended characteristics of a stent to be deployed within the vessel 702, including position, diameter, length, material, etc. The determination of the one or more characteristics can be based on the collected pressure data, computed pressure ratio(s), angiography data, a threshold pressure ratio, a target pressure ratio, an ideal pressure ratio, etc. In that regard, the stent can be described as a visualization based on pressure measurements. For example, the characteristics, such as the position and length, of the stent can be selected to remedy a drop in the pressure ratio across an obstruction. The computing device can determine the characteristics of the stent and generate display data to cause a stent to be displayed within the vessel 702 (as illustrated in FIG. 9). As described below, a clinician can modify the recommended characteristics of the stent. In some embodiments, selection of the insert stent field 716 provides a stent without determining its characteristics based on the collected pressure data, computed pressure ratio(s), and/or angiography data. In this manner, a clinician can customize the characteristics of the stent. For example, a clinician can provide a user input (such as a click and drag, or other suitable input) along the vessel 702, and computing device can provide a graphical representation of a stent having the length corresponding to the distance traversed by the user input along the vessel 702. In some embodiments, a plurality of stent options can be provided when the insert stent field 716 is selected, as described in greater detail with respect to FIG. 25.”). It would have been obvious to one of ordinary skill in the art, at the time the filing was made to apply Anderson to Oyagi so the system can use pixel size to determine the diameter of the vessel and use the diameter to accurately determine whether the subject has a stenosis in the vessel and treat the subject based on the determination and allow the user to see the stents to be more informed about the treatments or possible treatments.
With regard to claims 13 and 29 and 45:
Oyagi and Anderson disclose the method of claim 12, wherein the at least one stent and the image of the vessel are displayed at the same scale (Anderson paragraph 129: “Further, it is understood that PCI planning can include positioning and individually adjusting more than one stent within the vessel. In that regard, FIGS. 25 and 26 illustrate screen displaying having multiple graphical representations of stents. FIG. 25 illustrates screen display 2500 (or partial screen display) including a visual representation of a vessel having two graphical representations of stents 2502 and 2504. FIG. 26 illustrates a screen display 2600 (or partial screen display) of a visual representation of a pressure ratio having two graphical representations of stents 2602 and 2604. The data depicted in the screen display 2500 (FIG. 25) corresponds to the data shown in screen display 2600 (FIG. 26) and vice versa. PCI planning can include multiple graphical representations of stents when the angiography and/or physiologic data indicate multiple occlusions. For example, the pressure curve 852 of FIG. 26 includes two pressure drops 2610 and 2612 that can be attributable to distinct lesions. PCI planning can include determining to treat one or both of the lesions. While two stents are specifically referred to in the discussion of FIGS. 25 and 26, it is understood that the PCI planning can include any suitable number of stents, including one, two, three, four, five, six, or more.”) It would have been obvious to one of ordinary skill in the art, at the time the filing was made to apply Anderson to Oyagi so the system can use pixel size to determine the diameter of the vessel and use the diameter to accurately determine whether the subject has a stenosis in the vessel and treat the subject based on the determination and allow the user to see the stents to be more informed about the treatments.
With regard to claims 14 and 30 and 46:
Oyagi and Anderson disclose the method of claim 12, wherein the graphical user interface permits the at least one stent to be dragged and dropped onto the image of the vessel (Anderson fig. 25 and 26, paragraph 99: “The screen display 700 additionally includes an insert stent field 716. Selection of the insert stent field 716 can be a user input to modify the visual representation of the vessel and/or a visualization based on the pressure measurements. In some embodiments, selection of the insert stent field 716 can cause a computing device (e.g., computing device 172) to determine one or more recommended characteristics of a stent to be deployed within the vessel 702, including position, diameter, length, material, etc. The determination of the one or more characteristics can be based on the collected pressure data, computed pressure ratio(s), angiography data, a threshold pressure ratio, a target pressure ratio, an ideal pressure ratio, etc. In that regard, the stent can be described as a visualization based on pressure measurements. For example, the characteristics, such as the position and length, of the stent can be selected to remedy a drop in the pressure ratio across an obstruction. The computing device can determine the characteristics of the stent and generate display data to cause a stent to be displayed within the vessel 702 (as illustrated in FIG. 9). As described below, a clinician can modify the recommended characteristics of the stent. In some embodiments, selection of the insert stent field 716 provides a stent without determining its characteristics based on the collected pressure data, computed pressure ratio(s), and/or angiography data. In this manner, a clinician can customize the characteristics of the stent. For example, a clinician can provide a user input (such as a click and drag, or other suitable input) along the vessel 702, and computing device can provide a graphical representation of a stent having the length corresponding to the distance traversed by the user input along the vessel 702. In some embodiments, a plurality of stent options can be provided when the insert stent field 716 is selected, as described in greater detail with respect to FIG. 25.”) It would have been obvious to one of ordinary skill in the art, at the time the filing was made to apply Anderson to Oyagi so the system can use pixel size to determine the diameter of the vessel and use the diameter to accurately determine whether the subject has a stenosis in the vessel and treat the subject based on the determination and allow the user to see the stents and manipulate how the stents would be placed.
With regard to claims 15 and 31 and 47:
Oyagi and Anderson disclose The method of claim 1, further comprising generating an overlay file configured to be superimposed over and viewable together with the at least one angiographic image frame, the overlay file containing at least one graphical element selected from the group consisting of a dimensional scale for vessel measurement, an arrow, a number, and stent information (Anderson see fig. 13, 23, 25 and 26, paragraph 129: “Further, it is understood that PCI planning can include positioning and individually adjusting more than one stent within the vessel. In that regard, FIGS. 25 and 26 illustrate screen displaying having multiple graphical representations of stents. FIG. 25 illustrates screen display 2500 (or partial screen display) including a visual representation of a vessel having two graphical representations of stents 2502 and 2504. FIG. 26 illustrates a screen display 2600 (or partial screen display) of a visual representation of a pressure ratio having two graphical representations of stents 2602 and 2604. The data depicted in the screen display 2500 (FIG. 25) corresponds to the data shown in screen display 2600 (FIG. 26) and vice versa. PCI planning can include multiple graphical representations of stents when the angiography and/or physiologic data indicate multiple occlusions. For example, the pressure curve 852 of FIG. 26 includes two pressure drops 2610 and 2612 that can be attributable to distinct lesions. PCI planning can include determining to treat one or both of the lesions. While two stents are specifically referred to in the discussion of FIGS. 25 and 26, it is understood that the PCI planning can include any suitable number of stents, including one, two, three, four, five, six, or more.”). It would have been obvious to one of ordinary skill in the art, at the time the filing was made to apply Anderson to Oyagi so the system can use pixel size to determine the diameter of the vessel and use the diameter to accurately determine whether the subject has a stenosis in the vessel and treat the subject based on the determination and allow the user to see the stents to be more informed about the treatments.
With regard to claims 16 and 32 and 48:
Oyagi and Anderson disclose the method of claim 15, wherein the at least one graphical element is configured to be displayed at the same scale as the at least one angiographic image frame (Anderson paragraph 129: “Further, it is understood that PCI planning can include positioning and individually adjusting more than one stent within the vessel. In that regard, FIGS. 25 and 26 illustrate screen displaying having multiple graphical representations of stents. FIG. 25 illustrates screen display 2500 (or partial screen display) including a visual representation of a vessel having two graphical representations of stents 2502 and 2504. FIG. 26 illustrates a screen display 2600 (or partial screen display) of a visual representation of a pressure ratio having two graphical representations of stents 2602 and 2604. The data depicted in the screen display 2500 (FIG. 25) corresponds to the data shown in screen display 2600 (FIG. 26) and vice versa. PCI planning can include multiple graphical representations of stents when the angiography and/or physiologic data indicate multiple occlusions. For example, the pressure curve 852 of FIG. 26 includes two pressure drops 2610 and 2612 that can be attributable to distinct lesions. PCI planning can include determining to treat one or both of the lesions. While two stents are specifically referred to in the discussion of FIGS. 25 and 26, it is understood that the PCI planning can include any suitable number of stents, including one, two, three, four, five, six, or more.”) It would have been obvious to one of ordinary skill in the art, at the time the filing was made to apply Anderson to Oyagi so the system can use pixel size to determine the diameter of the vessel and use the diameter to accurately determine whether the subject has a stenosis in the vessel and treat the subject based on the determination and allow the user to see the stents to be more informed about the treatments or potential treatments.
Pertinent Arts
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kodandaramaiah, Pub. No.: 20210169334 A1: In some configurations, a vessel diameter tracking may be performed. Blue channel videos may be inverted, and the background may be subtracted, such as by using a rolling ball radius of 30 pixels. A select ROI may then be drawn around the vessel to be analyzed. In a non-limiting example, the ROI is a rectangle used as a guide to create 6 evenly spaced, horizontal lines along the height of the rectangle. The lines may be a select number of pixels (e.g. 5 pixels) thick and as long as the width of the rectangle. These lines may be used as ROIs to track the vessel diameter throughout a trial. To calculate vessel diameter, the intensity profile along a line may be plotted. Then, the maximum intensity and its corresponding location in pixels along the line may be found. Using half of the maximum intensity as a threshold, the pixel with the lowest intensity greater than the threshold in both directions from the maximum intensity may be found. The difference between the pixel locations of these two values was then stored as the vessel diameter. This process may be repeated for each line and each frame in a video.
Chen, Pub. No.: US 20210222128 A1: FIGS. 4C-4E are graphs showing quantification of percentage of branching nodes (FIG. 4C), percentage of vessels perfused (FIG. 4D), and average diameter of perfused vessels (i) and the relative frequency of each diameter (ii) (FIG. 4E) in devices seeded at different HUVEC:HDF ratios and fixed on day 7. # represents where data points removed due to no vessels being perfused in those devices. Each point represents one device. *: p<0.05, ****: p<0.0001, ns=not significant.
Conclusion
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/DI XIAO/Primary Examiner, Art Unit 2178