DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see pg. 10, filed 30 Jul 2026, with respect to the claim objections have been fully considered and are persuasive. The claim objections of 11 May 2026 have been withdrawn in view of the amended claims.
Applicant’s arguments, see pg. 10, filed 30 Jul 2026, with respect to the 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections of 11 May 2026 have been withdrawn in view of the amended claims.
Applicant’s arguments, see pg. 10-13, filed 30 Jul 2026, with respect to the 35 U.S.C. 102 and 103 rejections have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
Status of Claims
Claims 1-20 are currently under examination. No claim has been added, withdrawn, or cancelled since the Non-Final Office Action of 11 May 2026.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5, 8-10, 12-16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gopinath (US PG Pub No. 2018/0085170, provided by the Applicant in the IDS of 27 Mar 2025) – hereinafter referred to as Gopinath – in view of Courtney et al. (US PG Pub No. 2008/0177183) – hereinafter referred to as Courtney.
Regarding claim 1, Gopinath discloses an image diagnostic system (at least Fig. 1) comprising:
a catheter (Fig. 1: intravascular probe 7) insertable into a luminal organ (Fig. 1 and [0053]: probe 7 is disposed in relative to vessel wall) and including a plurality of imaging devices, the plurality of imaging devices including an ultrasound imaging device and an optical imaging device ([0049]: probe 7 includes optical coherence tomography (OCT) and intravascular ultrasound (IVUS));
a display (Fig. 1: display 46);
a memory (Fig. 1: computing device 40; [0053]: computing device 40 including local memory for processing data and utilizing software 44); and
a processor (Fig. 1: computing device 40; [0053]: computing device 40 including computer, processor, or an ASIC) configured to execute a program that is stored in the memory ([0053]: computing device 40 for processing data and utilizing software 44) to perform steps of:
generating tomographic images of the luminal organ based on signals that are output from the plurality of imaging devices ([0054]: intravascular data obtained with probe 7 processed to generate a cross-sectional, a longitudinal, and/or a three-dimensional view of the blood vessel along the length of the pullback region, and these views are depicted on user interface in subsequent figures),
combining the tomographic images to generate a first tomographic image (Fig. 5A-B: different views of the blood vessel combined to be displayed in one display; [0054]: generate and display information such as a cross-sectional, a longitudinal, and a three-dimensional view of the blood vessel along the length of the pullback region),
calculating one or more distributions of values each indicating an anatomical feature of the luminal organ from the first tomographic image ([0085]: lumen area/diameter curve generated as representation of lumen areas/diameters based on a representation of blood vessel created using data from an intravascular pullback imaging),
selecting at least one of the one or more distributions ([0085]-[0086]: identify local maxima (LM) corresponding to areas of the blood vessel within a lumen that is sufficiently wide to fit a stent as well as the frames corresponding to LM in the curve), and specifying one or more first portions of the luminal organ that are located along a longitudinal direction of the luminal organ and at which the selected distribution meets one or more conditions (Fig. 3A and [0086]: determine landing zones (LZ) based on frames with LM - in this case, meeting a condition includes being local maxima), and
controlling the display (Fig. 1: display 46) to display:
one or more graphs each illustrating a corresponding one of the calculated one or more distributions (Fig. 4A and [0087]: plot 120 of mean diameter (y-axis) versus frame number (x-axis) for a set of blood vessel data), and
one or more first graphics on the one or more graphs at locations corresponding to the specified one or more first portions (Fig. 4A and [0087]: plot 120 including local maxima shown as dark points along the curve).
Gopinath does not disclose:
the tomographic images including a tomographic image generated based on a signal output from the ultrasound imaging device and a tomographic image generated based on a signal output from the optical imaging device, and
extracting a region image from each of the tomographic images and combining the extracted region images to generate a first tomographic image.
In the same field of intravascular imaging, Courtney, however, teaches:
generating tomographic images including a tomographic image generated based on a signal output from the ultrasound imaging device and a tomographic image generated based on a signal output from the optical imaging device (Fig. 25a: first image from OCT and second image from IVUS each comprising region of interest 247), and
extracting a region image from each of the tomographic images and combining the extracted region images to generate a first tomographic image (Fig. 25a-b and [0232]-[0233]: inner border 245 identified in OCT, outer border 246 identified in IVUS, region of interest is co-registered between OCT and IVUS images, and generate a composite image for analysis of the region of interest 247).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gopinath’s system to include Courtney’s generation of both ultrasound and optical tomographic images, extracting region images from the ultrasound and optical tomographic images, and combining the extracted region images. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., generating and extracting from ultrasound and optical images a region of interest and combining the extracted images, as disclosed by Courtney), and the combination would have yielded a reasonable expectation of success since both Gopinath and Courtney are directed to intravascular imaging using both ultrasound and optical imaging. The motivation for the combination would have been to “improve the ability to identify important components within the vessel wall, such as calcified, fibrous, atheromatous, thrombotic, metallic and non-diseased regions”, as taught by Courtney ([0232]).
Regarding claim 12, Gopinath discloses an image diagnostic method performed by a system (at least Fig 1) that includes a catheter (Fig. 1: intravascular probe 7) insertable into a luminal organ (Fig. 1 and [0053]: probe 7 is disposed in relative to vessel wall) and including a plurality of imaging devices, the plurality of imaging devices including an ultrasound imaging device and an optical imaging device ([0049]: probe 7 includes optical coherence tomography (OCT) and intravascular ultrasound (IVUS)), the image diagnostic method comprising:
generating tomographic images of the luminal organ based on signals that are output from the plurality of imaging devices ([0054]: intravascular data obtained with probe 7 processed to generate a cross-sectional, a longitudinal, and/or a three-dimensional view of the blood vessel along the length of the pullback region, and these views are depicted on user interface in subsequent figures),
combining the tomographic images to generate a first tomographic image (Fig. 5A-B: different views of the blood vessel combined to be displayed in one display; [0054]: generate and display information such as a cross-sectional, a longitudinal, and a three-dimensional view of the blood vessel along the length of the pullback region),
calculating one or more distributions of values each indicating an anatomical feature of the luminal organ from the first tomographic image ([0085]: lumen area/diameter curve generated as representation of lumen areas/diameters based on a representation of blood vessel created using data from an intravascular pullback imaging),
selecting at least one of the one or more distributions ([0085]-[0086]: identify local maxima (LM) corresponding to areas of the blood vessel within a lumen that is sufficiently wide to fit a stent as well as the frames corresponding to LM in the curve), and specifying one or more first portions of the luminal organ that are located along a longitudinal direction of the luminal organ and at which the selected distribution meets one or more conditions (Fig. 3A and [0086]: determine landing zones (LZ) based on frames with LM - in this case, meeting a condition includes being local maxima); and
displaying (Fig. 1: display 46):
one or more graphs each illustrating a corresponding one of the calculated one or more distributions (Fig. 4A and [0087]: plot 120 of mean diameter (y-axis) versus frame number (x-axis) for a set of blood vessel data), and
one or more first graphics on the one or more graphs at locations corresponding to the specified one or more first portions (Fig. 4A and [0087]: plot 120 including local maxima shown as dark points along the curve).
In the same field of intravascular imaging, Courtney, however, teaches:
generating tomographic images including a tomographic image generated based on a signal output from the ultrasound imaging device and a tomographic image generated based on a signal output from the optical imaging device (Fig. 25a: first image from OCT and second image from IVUS each comprising region of interest 247), and
extracting a region image from each of the tomographic images and combining the extracted region images to generate a first tomographic image (Fig. 25a-b and [0232]-[0233]: inner border 245 identified in OCT, outer border 246 identified in IVUS, region of interest is co-registered between OCT and IVUS images, and generate a composite image for analysis of the region of interest 247).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gopinath’s method to include Courtney’s generation of both ultrasound and optical tomographic images, extracting region images from the ultrasound and optical tomographic images, and combining the extracted region images. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., generating and extracting from ultrasound and optical images a region of interest and combining the extracted images, as disclosed by Courtney), and the combination would have yielded a reasonable expectation of success since both Gopinath and Courtney are directed to intravascular imaging using both ultrasound and optical imaging. The motivation for the combination would have been to “improve the ability to identify important components within the vessel wall, such as calcified, fibrous, atheromatous, thrombotic, metallic and non-diseased regions”, as taught by Courtney ([0232]).
Regarding claims 2 and 13, Gopinath in view of Courtney discloses all limitations of claims 1 and 12, respectively as discussed above, and Gopinath further discloses:
wherein the one or more conditions are met when a predetermined number of values exceeds a threshold value, the predetermined number corresponding to a length of the first portions ([0089]: landing zones (LZ) based on local maximum lumen area/lumen diameter, where lumen area includes a length of a lumen).
Regarding claims 3 and 14, Gopinath in view of Courtney discloses all limitations of claims 1 and 12, respectively as discussed above, and Gopinath further discloses:
wherein the one or more conditions include a plurality of sets of conditions for said one of the one or more distributions ([0105]: an optimized search performed that maximizes one or more variables that influence a stent deployment decision and stent placement), and
specifying a plurality of sets of one or more second portions in the longitudinal direction of the luminal organ in which said one of the one or more distributions meets the plurality of sets of conditions (Fig. 5A-B and [0104]: determining landing zones LZ1 and LZ2 in longitudinal cross-section of the vessel for positioning a stent that is fit), and
controlling the display (Fig. 1: display 46) to display or displaying:
a list of the one or more graphs each illustrating said one of the one or more distributions (Fig. 5A-B: UID, UIE),
a total number of the one or more graphs corresponding to a total number of the plurality sets of conditions (Fig. 5A-B: UID, UIE; [0104]), and
a set of one or more second graphics on each of the one or more graphs corresponding to one of the plurality of sets of the one or more second portions (Fig. 5A-B and [0104]: line 176 on both screens 168 (UID) and 172 (UIE) corresponding to location of ring 166).
Regarding claims 4 and 15, Gopinath in view of Courtney discloses all limitations of claims 1 and 12, respectively as discussed above, and Gopinath further discloses:
wherein the luminal organ is a blood vessel (Fig. 1 and [0053]: probe 7 is disposed in relative to vessel wall), and
each of the values of the one or more distributions that exceed a threshold value indicates a ratio of an area of plaque to a membrane area inside a part of the blood vessel (Fig. 3B and [0060]: local maxima at frames F1 and F2 indicating stenosis 102 between frames F1 and F2; Fig. 3A: area of stenosis 102 relative to vessel 106).
Regarding claims 5 and 16, Gopinath in view of Courtney discloses all limitations of claims 1 and 12, respectively as discussed above, and Gopinath further discloses:
wherein each of the values of the one or more distributions that are less than a threshold value indicates an average lumen diameter of a part of the luminal organ (Fig. 4A: mean lumen diameter per frame; [0087]).
Regarding claims 8 and 19, Gopinath in view of Courtney discloses all limitations of claims 1 and 12, respectively as discussed above, and Gopinath further discloses:
specifying a side branch of the luminal organ in the first tomographic image (Fig. 3A and [0058]-[0059]: side branch 104 is shown; Fig. 12A: side branches SB), and
said controlling includes controlling the display to display or displaying a second graphic at a location of the display where the side branch is specified (Fig. 3A and Fig. 12A).
Regarding claim 9, Gopinath in view of Courtney discloses all limitations of claim 1, as discussed above, and Gopinath further discloses:
wherein said controlling includes controlling the display to display one or more graphical user interface (GUI) components through which one or more values related to the conditions can be input ([0118]: parameters displayed as GUI components on user interface; [0080]: a user selected flow related value input via a user interface; [0102]).
Regarding claim 10, Gopinath in view of Courtney discloses all limitations of claim 9, as discussed above, and Gopinath further discloses:
wherein the values that can be input are threshold values to be compared to the values indicating the anatomical feature of the luminal organ ([0080]: a user selected flow related value input via a user interface).
Regarding claim 20, Gopinath discloses a non-transitory computer readable storage medium (Fig. 1: computing device 40; [0053]: computing device 40 including local memory for processing data and utilizing software 44) storing a program causing a computer to execute an image diagnostic method ([0053]: computing device 40 also including computing, processor, or an ASIC for processing data and utilizing software 44) comprising:
generating tomographic images of the luminal organ based on signals that are output from a plurality of imaging devices, the plurality of imaging devices including an ultrasound imaging device and an optical imaging device ([0049]: probe 7 includes optical coherence tomography (OCT) and intravascular ultrasound (IVUS); [0054]: intravascular data obtained with probe 7 processed to generate a cross-sectional, a longitudinal, and/or a three-dimensional view of the blood vessel along the length of the pullback region, and these views are depicted on user interface in subsequent figures),
combining the tomographic images to generate a first tomographic image (Fig. 5A-B: different views of the blood vessel combined to be displayed in one display; [0054]: generate and display information such as a cross-sectional, a longitudinal, and a three-dimensional view of the blood vessel along the length of the pullback region),
calculating one or more distributions of values each indicating an anatomical feature of the luminal organ from the first tomographic image ([0085]: lumen area/diameter curve generated as representation of lumen areas/diameters based on a representation of blood vessel created using data from an intravascular pullback imaging),
selecting at least one of the one or more distributions ([0085]-[0086]: identify local maxima (LM) corresponding to areas of the blood vessel within a lumen that is sufficiently wide to fit a stent as well as the frames corresponding to LM in the curve), and specifying one or more first portions of the luminal organ that are located along a longitudinal direction of the luminal organ and at which the selected distribution meets one or more conditions (Fig. 3A and [0086]: determine landing zones (LZ) based on frames with LM - in this case, meeting a condition includes being local maxima); and
displaying (Fig. 1: display 46):
one or more graphs each illustrating a corresponding one of the calculated one or more distributions (Fig. 4A and [0087]: plot 120 of mean diameter (y-axis) versus frame number (x-axis) for a set of blood vessel data), and
one or more first graphics on the one or more graphs at locations corresponding to the specified one or more first portions (Fig. 4A and [0087]: plot 120 including local maxima shown as dark points along the curve).
Gopinath does not disclose:
the tomographic images including a tomographic image generated based on a signal output from the ultrasound imaging device and a tomographic image generated based on a signal output from the optical imaging device, and
extracting a region image from each of the tomographic images and combining the extracted region images to generate a first tomographic image.
In the same field of intravascular imaging, Courtney, however, teaches:
generating tomographic images including a tomographic image generated based on a signal output from the ultrasound imaging device and a tomographic image generated based on a signal output from the optical imaging device (Fig. 25a: first image from OCT and second image from IVUS each comprising region of interest 247), and
extracting a region image from each of the tomographic images and combining the extracted region images to generate a first tomographic image (Fig. 25a-b and [0232]-[0233]: inner border 245 identified in OCT, outer border 246 identified in IVUS, region of interest is co-registered between OCT and IVUS images, and generate a composite image for analysis of the region of interest 247).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gopinath’s storage medium to include Courtney’s generation of both ultrasound and optical tomographic images, extracting region images from the ultrasound and optical tomographic images, and combining the extracted region images. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., generating and extracting from ultrasound and optical images a region of interest and combining the extracted images, as disclosed by Courtney), and the combination would have yielded a reasonable expectation of success since both Gopinath and Courtney are directed to intravascular imaging using both ultrasound and optical imaging. The motivation for the combination would have been to “improve the ability to identify important components within the vessel wall, such as calcified, fibrous, atheromatous, thrombotic, metallic and non-diseased regions”, as taught by Courtney ([0232]).
Claims 6 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gopinath in view of Courtney, as applied to claims 1 and 12, respectively above, and further in view of Imura et al. (US PG Pub No. 2024/0086025, priority date of 14 Sep 2022) – hereinafter referred to as Imura.
Regarding claims 6 and 17, Gopinath in view of Courtney discloses all limitations of claims 1 and 12, respectively as discussed above, and Gopinath further discloses:
wherein the luminal organ is a blood vessel (Fig. 1 and [0053]: probe 7 is disposed in relative to vessel wall),
calculating a second distribution of second values each indicating an average lumen diameter of a part of the blood vessel (Fig. 4A: mean lumen diameter per frame; [0087]),
specifying one or more portions of the blood vessel at which locations the second values are less than a second threshold value (Fig. 4A and [0087]: values in plot 120 that are not shown as dark points along the curve are not local maxima), and
controlling the display to display or displaying a second graph illustrating the distribution of the second values (Fig. 4A and [0087]: values in plot 120 that are not shown as dark points along the curve are not local maxima), and
one or more graphics on the second graph at locations of the second graph corresponding to the portions at which the second values are less than the second threshold value (Fig. 4A and [0087]: values in plot 120 that are not shown as dark points along the curve are not local maxima).
Gopinath does not disclose:
calculating a first distribution of first values each indicating a ratio of an area of plaque to a membrane area inside a part of the blood vessel,
specifying one or more portions of the blood vessel at which locations the first values exceed a first threshold value, and
controlling the display to display or displaying a first graph illustrating the distribution of the first values, and
one or more graphics on the first graph at locations of the first graph corresponding to the portions at which the first values exceed the first threshold value.
In the same field of intravascular imaging, Imura, however, teaches:
calculating a first distribution of first values each indicating a ratio of an area of plaque to a membrane area inside a part of the blood vessel ([0073]: automatic assessments of images performed (e.g., plaque burden detection); [0119]: assessments include plaque burden (e.g., ratio of lumen to vessel area)),
specifying one or more portions of the blood vessel at which locations the first values exceed a first threshold value (Fig. 12B and [0119]: assessments include the plaque burden (e.g., ratio of lumen to vessel area) and the frame number (e.g., image number in the series of IVUS images 418), and
controlling the display to display or displaying a first graph illustrating the distribution of the first values (Fig. 14A: scale 1308; [0126]: scale 1308 depicting the radius of the detected borders represented in longitudinal border profile 1304), and
one or more graphics on the first graph at locations of the first graph corresponding to the portions at which the first values exceed the first threshold value (Fig. 14A and [0127]: shade or color the area between vessel border 1106 and lumen border 1108 to indicate plaque).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gopinath’s system or method to include Imura’s method of automatic assessment of acquired images for plaque burden detection. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., performing an automatic assessment of acquired images, as disclosed by Imura), and the combination would have yielded a reasonable expectation of success since both Gopinath and Imura are directed to an intravascular imaging for a vessel assessment. The motivation for the combination would have been to “process and analyze the signals generated during an IVUS run. Such information can include automatic detection of a lesion”, as taught by Imura ([0007]).
Claims 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gopinath in view of Courtney, as applied to claims 1 and 12, respectively above, and further in view of Choi et al. (US PG Pub No. 2021/0090249) – hereinafter referred to as Choi.
Regarding claims 7 and 18, Gopinath in view of Courtney discloses all limitations of claims 1 and 12, respectively as discussed above, and Gopinath does not disclose:
specifying a lipid plaque in the first tomographic image, and
controlling the display to display or displaying a second graphic at a location of the display where the lipid plaque is specified.
In the same field of intravascular imaging, Choi, however, teaches:
specifying a lipid plaque in the first tomographic image (Fig. 9: image 910; [0116]: displaying the location and composition of the plaque), and
controlling the display to display or displaying a second graphic at a location of the display where the lipid plaque is specified ([0116]: displaying a plaque in danger (e.g., a lipid-containing plaque) marked (e.g., in yellow)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gopinath’s system and method to include Choi’s method of specifying a lipid plaque and displaying the lipid plaque with a graphic. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., identifying and displaying a lipid plaque, as disclosed by Choi), and the combination would have yielded a reasonable expectation of success since both Gopinath and Choi are directed to an intravascular imaging for a vessel assessment. The motivation for the combination would have been to provide “the location and composition of the plaque included in the object's cardiovascular artery 902 on the basis of the determination result”, as taught by Choi ([0116]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gopinath in view of Courtney, as applied to claim 1 above, and further in view of Imura.
Regarding claim 11, Gopinath in view of Courtney discloses all limitations of claim 1, as discussed above, and Gopinath does not disclose:
wherein one of the GUI components is a slide bar displayed adjacent to one of the graphs.
In the same field of intravascular imaging, Imura, however, teaches:
one of GUI components is a slide bar displayed adjacent to a graph (Fig. 9: view slider 708 adjacent vessel long views 1510 and 1512).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gopinath’s system to include Imura’s slide bar GUI adjacent a displayed graph. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., providing a slide bar control on a user interface, as disclosed by Imura), and the combination would have yielded a reasonable expectation of success since both Gopinath and Imura are directed to an intravascular imaging for a vessel assessment. The motivation for the combination would have been to allow “a user can drag (e.g., via a touch screen, via a mouse, or the like) one of the brackets to change the position of the key frame represented by the bracket”, as taught by Imura ([0103]), thus providing a user friendly interface.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Y.C./Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 10/9/26
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