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. 6, filed 20 Jan 2026, with respect to the claim objections have been fully considered and are persuasive. The claim objections of 20 Oct 2025 have been withdrawn in view of the amended claims.
Applicant’s arguments, see pg. 6, filed 20 Jan 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 The 35 U.S.C. 112(b) rejections of 20 Oct 2025 have been withdrawn in view of the amended claims.
Applicant's arguments, see pg. 6-7, filed 20 Jan 2026, with respect to the 35 U.S.C. 101 rejections have been fully considered but they are not persuasive.
Applicant first argues, see pg. 6-7 that “the recited display includes "a series of the live images of the one or more blood vessels with the one or more captured images appearing between the live images within the series." In addition, the captured images are identified and are added "in addition to the live images, by being placed between the live images based on the live heart-cycle data and the portion of the heart-cycle data for which the one or more images have been associated.” Applicant submits that the generation of such a display that includes captured images in addition to the live images based on the live heart-cycle data is not a process that can be "practically performed in the human mind," …” However, the Examiner respectfully disagrees. Claim 1 merely recites the limitation “providing for display, by the one or more processors, a series of the live images of the one or more blood vessels with the one or more captured images …”, which can be performed by a user manually “providing” for a display. Additionally, the limitation “wherein the one or more captured images are added in addition to the live images, by being placed between the live images …” certainly also can be performed by a user manually “adding” captured images to live images. Applicant is reminded that claim does not recite any step of “generating” images, but rather “acquiring” and “providing for display” the images that have been associated and identified, where the steps of “associating” and “identifying” can be practically performed in the human mind.
Applicant secondly argues, see pg. 7, that “the claims go beyond recitation of nay abstract idea, as the claims recite claim elements that provide a specific practical application of image analysis and display that produces an improved technical feature that goes beyond merely reciting an abstract idea.” However, the Examiner respectfully disagrees. Applicant merely argues without any evidence that the claims rejected under 35 U.S.C. 101 have “an improved technical feature that goes beyond merely reciting an abstract idea”. Other than dependent claims 6-8 and 16, which actually do recite a practical application, claims 1-5, 8-15, and 17-20 recite an abstract idea without a practical application as presented previously in the Non-Final Office Action of 20 Oct 2025 and in the 35 U.S.C. 101 rejections below. See the 35 U.S.C. 101 rejections below.
Applicant's arguments, see pg. 7-8, filed 20 Jan 2026 have been fully considered but they are not persuasive.
Applicant argues, see pg. 8, that “the images (of Uehara) disclosed in connection with Figure 4 are only composite images, meaning that no image is added to the series of live images. Instead, the live X-ray images of Figure 4 are altered using other X-ray images in the "region of interest." Accordingly, the live X-ray images of Uehara are either "non-composite" or "composite" meaning that every image corresponds either to an unaltered live image or an altered live image. (Uehara, paras. [0074]-[0080]).” However, the Examiner respectfully disagrees. Uehara explicitly discloses in [0054] that its “composite images, whose regions outside the ROI are the previously acquired first X-ray images and regions inside the ROI are the second X-ray images acquired in real time, are dynamically displayed as a moving image”. Thus, both non-composite and composite displays of Uehara display a series of live second X-ray images, and the composite displays specifically include previously acquired first X-ray images that are added to a series of live second X-ray images in the region outside of ROI of live second X-ray images. See the 35 U.S.C. 103 rejections below.
Applicant’s arguments, see pg. 9, filed 20 Jan 2026 with respect to the Double Patenting rejections have been considered, and the Double Patenting rejections are hereby being maintained as “Applicant respectfully requests that the double patenting rejection be held in abeyance until the claims have otherwise been determined to be in a condition for allowance.”
Status of Claims
Claims 1-20 are currently under examination. No claim has been cancelled, added, nor withdrawn since the Non-Final Office Action of 20 Oct 2025.
Claim Rejections - 35 USC § 101
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, 9-15, and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites a method of displaying images of one or more blood vessels comprising: acquiring, by one or more processors, a set of captured images of one or more blood vessels and heart-cycle data; associating, by the one or more processors, each image from the first set of captured images with a portion of the heart-cycle data; acquiring, by the one or more processors, live images of the one or more blood vessels and live heart-cycle data; identifying, by the one or more processors, one or more captured images from the set of captured images to be displayed between the live images, wherein the one or more captured images are to be placed between the live images based on the live heart-cycle data and the portion of the heart-cycle data for which the one or more images have been associated; and providing for display, by the one or more processors, a series of the live images of the one or more blood vessels with the one or more captured images appearing between the live images within the series.
Step 1: Statutory Category: YES – Claim 1 is directed to a method of displaying images, thus is a method claim.
Step 2A, Prong 1, Judicial Exception: YES – Claim 1 recites associating each image from the set of captured images with a portion of the heart-cycle data; identifying one or more captured images from the set of captured images to be displayed between the live images, wherein the one or more captured images are added in addition to the live images, by being placed between the lives images based on the live heart-cycle data and the portion of the heart-cycle data for which the one or more images have been associated; and providing for display a series of the live images of the one or more blood vessels with the one or more captured images added to the series of the live images by appearing between the live images within the series.
These limitations, as drafted, are a process that under their broadest reasonable interpretation, cover performance of the limitation in the mind but for the recitation of a generic computer component. That is, other than reciting “by the one or more processors”, nothing in the claim element precludes each step from practically being performed in the mind. For example, but for the “by the one or more processors” language, “associating” in the context of this claim encompasses the user manually associating each image from the first set of captured images with a portion of the heart-cycle data. Similarly, the limitation of identifying one or more captured images from the set of captured images to be displayed between the live images, by placing as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of a generic computer component. Also, the limitation “wherein the one or more captured images are added in addition to the live images by being placed between the live images based on the live heart-cycle data and the portion of the heart-cycle data for which the one or more images have been associated” encompasses the user manually adding non-live images to a series of live images. Additionally, but for the “by the one or more processors" language, “providing” in the context of this claim encompasses the user manually providing for display a series of the live images of the one or more blood vessels with the one or more captured images added to the series by appearing between the live images within the series. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of a generic computer component, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. Similar processes performed by pencil and paper are also considered abstract under the mental processes category. In this case, images may be printed out onto paper sheets and arranged by hand to arrive at the claim.
Step 2A, Prong 2, Integrated into Practical Application: No – This judicial exception recited in claim 1 is not integrated into a practical application. In particular, the claim recites the additional element of using one or more processors to perform associating, identifying, and providing for display. The processor in these steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of associating, identifying, and providing for display) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Furthermore, the claim recites additional limitations of acquiring a set of captured images of the one or more blood vessels and heart-cycle data; and acquiring live images of the one or more blood vessels and live heart-cycle data. However, the limitations of acquiring sets of captured and live images are cited at a high-level of generality (i.e., as a general means of gathering sets of images for use in associating, identifying, and providing for display) and amount to mere data gathering, which is a form of insignificant extra-solution activity. Accordingly, the additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Therefore, the claim is directed to an abstract idea.
Step 2B, Inventive Concept: No – The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform associating, identifying, and providing for display amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Additionally, the additional elements of acquiring sets of captured and live images amount to mere data gathering, which is a form of insignificant extra-solution activity. Further, the limitation “wherein the one or more captured images are to be placed between the live images based on the live heart-cycle data and the portion of the heart-cycle data for which the one or more images have been associated” recites an intended use of the claimed one or more captured images. Therefore, claim 1 is not patent eligible.
Claims 2-5 and 9-10 inherit the deficiencies of claim 1, the claimed invention being directed to an abstract idea (see the 35 U.S.C. 101 analysis for claim 1 discussed above), and additionally recite:
wherein the set of captured images are angiographic images and the live images are fluoroscopic images (claims 2-3);
wherein the fluoroscopic images are live images of the subject during an intravascular procedure (claim 3);
wherein the heart-cycle data includes aortic (AO) pressure values (claim 4);
wherein the heart-cycle data includes ECG values (claim 5);
placing the one or more captured images between the live images by replacing one or more of the live images with the one or more captured images (claims 9-10); and
wherein the one or more captured images identified from the set of captured images and the live images are each captured during a corresponding portion of a heart cycle (claim 10).
However, these additional limitations do not appear to integrate the judicial exception into a practical application and are not sufficient to amount to significantly more than the judicial exception. In particular, the limitation “placing the one or more captured images between the live images by replacing one or more of the live images with the one or more captured images” recited in claim 9 can be performed by a user manually replacing images. Therefore, claims 2-5 and 9-10 are not patent eligible.
Claim 11 recites a system for displaying images of one or more blood vessels comprising: a memory for storing image data of the one or more blood vessels; and one or more processors in communication with the memory, the one or more processors being configured to: acquire a set of captured images of the one or more blood vessels and heart-cycle data; associate each image from the first set of captured images with a portion of the heart-cycle data; acquire live images of the one or more blood vessels and live heart-cycle data; identify one or more captured images from the set of captured images to be displayed between the live images, wherein the one or more captured images are added in addition to the live images, by being placed between the live images based on the live heart-cycle data and the portion of the heart-cycle data for which the one or more images have been associated; and provide for display a series of the live images of the one or more blood vessels with the one or more captured images added to the series of the live images by appearing between the live images within the series.
Step 1: Statutory Category: YES – Claim 11 recites “a system for displaying images of one or more blood vessels”, therefore is a device claim.
Step 2A, Prong 1, Judicial Exception: YES – These limitations, as drafted, are a computer-implemented process that under their broadest reasonable interpretation, cover performance of the limitation in the mind but for the recitation of a generic computer component. That is, other than reciting “the one or more processors being configured to”, nothing in the claim element precludes each step from practically being performed in the mind. For example, but for the “the one or more processors being configured to” language, “associating” in the context of this claim encompasses the user manually associating each image from the first set of captured images with a portion of the heart-cycle data. Similarly, the limitation of identify one or more captured images from the set of captured images to be displayed between the live images, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of a generic computer component. Also, the limitation “wherein the one or more captured images are added in addition to the live images by being placed between the live images based on the live heart-cycle data and the portion of the heart-cycle data for which the one or more images have been associated” encompasses the user manually adding non-live images to a series of live images. Additionally, but for the “the one or more processors being configured to" language, “providing” in the context of this claim encompasses the user manually providing for display a series of the live images of the one or more blood vessels with the one or more captured images added to the series of lives images by appearing between the live images within the series. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of a generic computer component, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. Similar processes performed by pencil and paper are also considered abstract under the mental processes category. In this case, images may be printed out onto paper sheets and arranged by hand to arrive at the claim.
Step 2A, Prong 2, Integrated into Practical Application: No – This judicial exception recited in claim 12 is not integrated into a practical application. In particular, the claim recites the additional element of one or more processors being operable to associate, identify, and provide for display. The processor in these steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of associating, identifying, and providing for display) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Additionally, the claim recites additional limitations of a memory for storing image data of one or more blood vessels and the one or more processors in communication with the memory. The memory and the processor are recited at a high-level of generality (i.e., as a general means of storing image data and communicating with the data storage, respectively) and are well known and conventional. Furthermore, the claim recites additional limitations of acquiring a set of captured images of one or more blood vessels and heart-cycle data and acquiring live images of the one or more blood vessels and live heart-cycle data. However, the limitations of acquiring sets of captured and live images are cited at a high-level of generality (i.e., as a general means of gathering sets of captured and live images for use in correlating, identifying, and providing for display) and amounts to mere data gathering, which is a form of insignificant extra-solution activity. Accordingly, the additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Therefore, the claim is directed to an abstract idea.
Step 2B, Inventive Concept: No – The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform associating, identifying, and providing for display amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Additionally, the additional elements of a memory and one or more processors in communication with the memory are well known and conventional, and the additional elements of acquiring sets of subject images and time-varying data amounts to mere data gathering, which is a form of insignificant extra-solution activity. Therefore, claim 11 is not patent eligible.
Claims 12-15 and 17-20 inherit the deficiencies of claim 11, the claimed invention being directed to an abstract idea (see the 35 U.S.C. 101 analysis for claim 11 discussed above), and additionally recite:
wherein the set of captured images are angiographic images and the live images are fluoroscopic images (claims 12-13);
wherein the fluoroscopic images are live images of the subject during an intravascular procedure (claim 13);
wherein the heart-cycle data includes aortic (AO) pressure values (claim 14);
wherein the heart-cycle data includes ECG values (claim 15);
wherein the one or more processors are further configured to co-register the set of intravascular image frames and the set of captured images (claims 17-18);
wherein the one or more processors are further configured to provide for display at least a subset of the set of intravascular image frames along with one or more of the live images (claim 18);
wherein the one or more processors are further configured to place the one or more captured images between the live images by replacing one or more of the live images with the one or more captured images (claim 19-20); and
wherein the one or more captured images identified from the set of captured images and the live images are each captured during a corresponding portion of a heart cycle (claim 20).
However, these additional limitations do not appear to integrate the judicial exception into a practical application and are not sufficient to amount to significantly more than the judicial exception. In particular, the limitations recited in claims 17-19 can be performed mentally or manually by a user. Therefore, claims 12-15 and 17-20 are not patent eligible.
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 1-3, 5, 9-13, 15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Baek et al. (Korean Patent Pub No. KR2019/0118454A, provided by the Applicant in the IDS of 19 Sep 2024, a copy of machine translation relied upon previously provided in the Non-Final Office Action of 20 Oct 2025) - hereinafter referred to as Baek - in view of Uehara et al. (US Patent Pub No. 2014/0328462, provided by the Applicant in the IDS of 19 Sep 2024) - hereinafter referred to as Uehara.
Regarding claim 1, Baek discloses a method of displaying one or more blood vessels (at least Fig. 7) comprising:
acquiring, by one or more processors (controller 340), a set of captured images of one or more blood vessels and heart-cycle data (Fig. 4: 420 and 410 and [0055]-[0064]: image acquirer 320 captures angiography images 420 and ECG signal 410; Fig. 5 and [0063]: angiographic images to acquire shape information of blood vessels such as contours; [0059]: acquire and store a plurality of viewpoint information corresponding to the angiography images 420 of the plurality of frames 1 to 11, respectively);
acquiring, by the one or more processors (controller 340), live images of the one or more blood vessels and live heart-cycle data (Fig. 6: Fluoroscopy including a blood vessel and ECG; [0047]: take a real-time X-ray fluoroscopy image; [0027]: singular expressions include plural expressions; [0050]: acquire an electrocardiogram signal when the real-time X-ray fluoroscopy image is captured);
identifying, by the one or more processors (controller 340), one or more captured images from the set of captured images to be displayed with the live images (Fig. 7: image 425 and t2 of 610; [0079]-[0080]: specific frame of angiography images corresponding to the specific viewpoint information, which correspond to real time view point information, is acquired); and
providing for display, by the one or more processors (controller 340), a series of the live images of the one or more blood vessels and the one or more captured images ([0096]: the first X-ray fluoroscopy image 710 and the fifth frame that are temporally matched displayed on the third display unit; [0047]: take a real-time X-ray fluoroscopy image; [0027]: singular expressions include plural expressions).
It is noted that the limitation “wherein the one or more captured images are to be placed between the live images based on the live heart-cycle data and the portion of the heart-cycle data for which the one or more images have been associated” recites an intended use of the claimed one or more captured images, thus is given a limited patentable weight.
Baek does not disclose:
associating, by the one or more processors, each image from the first set of captured images with a portion of the heart-cycle data;
wherein the one or more captured images are added in addition to the live images, by being placed between the live images based on the live heart-cycle data and the portion of the heart-cycle data for which the one or more images have been associated; and
providing for display, by the one or more processors, a series of the live images of the one or more blood vessels with the one or more captured images added to the series of the live images by appearing between the live images within the series.
In the same field of displaying previously captured and live images together, Uehara, however, teaches:
associating, by one or more processors (medical image processing apparatus 18 including image composition part 24), each image from the first set of captured images with a portion of the heart-cycle data (Fig. 2: S2; [0047]-[0048]: phase information of ECG signal added to first X-ray image data resulting in frames of first X-ray image data respectively corresponding to different plural cardiac time phases);
adding the one or more captured images in addition to the live images by placing the one or more captured images between the live images based on the live heart-cycle data and the portion of the heart-cycle data for which the one or more images have been associated (Fig. 4; [0054]: composite images, whose regions outside the ROI are the previously acquired first X-ray images and regions inside the ROI are the second X-ray images acquired in real time, are dynamically displayed as a moving image, thus previously acquired first X-ray images are added to a series of live second X-ray images that are displayed lives in series; [0053]: frames of live second X-ray image data have cardiac time phases correspond to those of the frames of previously acquired first X-ray image data based on information indicating plural cardiac time phases added to each of the first and second X-ray image data); and
providing for display, by the one or more processors (medical image processing apparatus 18 including image composition part 24), a series of live images with the one or more captured images added to the series of the live images by appearing between the live images within the series (Fig. 4; [0075]: imaging the first X-ray image data in an imaging region including an ROI for a live display to display the first X-ray image data without composition and displaying the first X-ray image data combined with the second X-ray image data in the ROI for the live display can be alternately repeated; [0036]: perform image composition processing which replaces the part, corresponding to the second ROI, out of the first X-ray image data, into the second X-ray image data; [0054]: composite images, whose regions outside the ROI are the previously acquired first X-ray images and regions inside the ROI are the second X-ray images acquired in real time, are dynamically displayed as a moving image, thus previously acquired first X-ray images are added to a series of live second X-ray images that are displayed lives in series).
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 Beck’s method of displaying angiograms and fluoroscopic images to include Uehara’s method of associating ECG data to the previously captured X-ray images for matching the previously captured images and the live images and providing for display a series of live images with previously captured images appearing between the live images. One of ordinary skill in the art would have combined the elements as claimed, and the combination would have yielded a reasonable expectation of success, since both Baek and Uehara are directed to acquiring two sets of images and related heart cycle data and displaying the two sets of images together based on the heart cycle data. The motivation for the combination would have been to allow “A cardiac time phase, added to the X-ray image data, as incidental information can be indicated as a phase angle to a reference wave such as the R wave, or as a delay time from a reference wave such as the R wave”, as taught by Uehara ([0033]) and to “alternately display the new first X-ray image data and the composite image data, between the new first X-ray image data and the second X-ray image data, on the display unit,” as taught by Uehara ([0081]), providing both first and second X-ray image data together.
Regarding claim 11, Baek discloses a system for displaying one or more blood vessels (at least Fig. 7) comprising:
a memory (storage unit 310) for storing image data of one or more blood vessels ([0034]-[0039]: store a plurality of angiography images and a plurality of viewpoint information indicating electrocardiogram signal at each of the time points at which the angiography images of the plurality of frames are acquired; Fig. 5 and [0063]: angiographic images to acquire shape information of blood vessels such as contours); and
one or more processors (controller 340) in communication with the memory (Fig. 3 and [0057]-[0064]: store the angiography image 420 of the plurality of frames and ECG signal in the storage unit), the one or more processors being configured to:
acquire a set of captured images of one or more blood vessels and heart-cycle data (Fig. 4: 420 and 410 and [0055]-[0064]: image acquirer 320 captures angiography images 420 and ECG signal 410; Fig. 5 and [0063]: angiographic images to acquire shape information of blood vessels such as contours; [0059]: acquire and store a plurality of viewpoint information corresponding to the angiography images 420 of the plurality of frames 1 to 11, respectively);
acquire live images of the blood vessels and live heart-cycle data (Fig. 6: Fluoroscopy including a blood vessel and ECG; [0047]: take a real-time X-ray fluoroscopy image; [0027]: singular expressions include plural expressions; [0050]: acquire an electrocardiogram signal when the real-time X-ray fluoroscopy image is captured);
correlate the first set of time-varying data with the second set of time-varying data ([0077]: compare current ECG signal included in the real-time view point information t2 and the ECG signal in one heartbeat period at the time when a plurality of angiography images are captured through a cross-correlation method);
identify one or more captured images from the set of captured images to be displayed with the live images (Fig. 7: image 425 and t2 of 610; [0079]-[0080]: specific frame of angiography images corresponding to the specific viewpoint information, which correspond to real time view point information, is acquired); and
provide for display a series of the live images of the one or more blood vessels and the one or more captured images ([0096]: the first X-ray fluoroscopy image 710 and the fifth frame that are temporally matched displayed on the third display unit; [0047]: take a real-time X-ray fluoroscopy image; [0027]: singular expressions include plural expressions).
It is noted that the limitation “wherein the one or more captured images are to be placed between the live images based on the live heart-cycle data and the portion of the heart-cycle data for which the one or more images have been associated” recites an intended use of the claimed one or more captured images, thus is given a limited patentable weight.
Baek does not disclose:
associating, by the one or more processors, each image from the first set of captured images with a portion of the heart-cycle data;
wherein the one or more captured images are added in addition to the live images, by being placed between the live images based on the live heart-cycle data and the portion of the heart-cycle data for which the one or more images have been associated; and
providing for display, by the one or more processors, a series of the live images of the one or more blood vessels with the one or more captured images added to the series of the live images by appearing between the live images within the series
In the same field of displaying previously captured and live images together, Uehara, however, teaches:
associating each image from the set of captured images with a portion of the heart-cycle data (Fig. 2: S2; [0047]-[0048]: phase information of ECG signal added to first X-ray image data resulting in frames of first X-ray image data respectively corresponding to different plural cardiac time phases);
adding the one or more captured images in addition to the live images by placing the one or more captured images between the live images based on the live heart-cycle data and the portion of the heart-cycle data for which the one or more images have been associated (Fig. 4; [0054]: composite images, whose regions outside the ROI are the previously acquired first X-ray images and regions inside the ROI are the second X-ray images acquired in real time, are dynamically displayed as a moving image, thus previously acquired first X-ray images are added to a series of live second X-ray images that are displayed lives in series; [0053]: frames of live second X-ray image data have cardiac time phases correspond to those of the frames of previously acquired first X-ray image data based on information indicating plural cardiac time phases added to each of the first and second X-ray image data); and
providing for display a series of live images with the one or more captured images added to the series of the live images by appearing between the live images within the series (Fig. 4; [0075]: imaging the first X-ray image data in an imaging region including an ROI for a live display to display the first X-ray image data without composition and displaying the first X-ray image data combined with the second X-ray image data in the ROI for the live display can be alternately repeated; [0036]: perform image composition processing which replaces the part, corresponding to the second ROI, out of the first X-ray image data, into the second X-ray image data; [0054]: composite images, whose regions outside the ROI are the previously acquired first X-ray images and regions inside the ROI are the second X-ray images acquired in real time, are dynamically displayed as a moving image, thus previously acquired first X-ray images are added to a series of live second X-ray images that are displayed lives in series).
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 Beck’s system for displaying angiograms and fluoroscopic images to include Uehara’s method of associating ECG data to the previously captured X-ray images for matching the previously captured images and the live images and providing for display a series of live images with previously captured images appearing between the live images. One of ordinary skill in the art would have combined the elements as claimed, and the combination would have yielded a reasonable expectation of success, since both Baek and Uehara are directed to acquiring two sets of images and related heart cycle data and displaying the two sets of images together based on the heart cycle data. The motivation for the combination would have been to allow “A cardiac time phase, added to the X-ray image data, as incidental information can be indicated as a phase angle to a reference wave such as the R wave, or as a delay time from a reference wave such as the R wave”, as taught by Uehara ([0033]) and to “alternately display the new first X-ray image data and the composite image data, between the new first X-ray image data and the second X-ray image data, on the display unit,” as taught by Uehara ([0081]), providing both first and second X-ray image data together.
Regarding claims 2-3 and 12-13, Baek in view of Uehara discloses all limitations of claims 1 and 11, respectively, as discussed above, and Baek further discloses:
wherein the set of captured images are angiographic images ([0055]: angiographic images 420) and the live images are fluoroscopic images (Fig. 6: Fluoroscopy; [0047]: take a real-time X-ray fluoroscopy image; [0027]: singular expressions include plural expressions) (claims 2-3 and 12-13); and
wherein the fluoroscopic images are live images of the subject during an intravascular procedure (Fig. 6: Fluoroscopy; [0047]: take a real-time X-ray fluoroscopy image; [0027]: singular expressions include plural expressions; [0100]: intravascular location information of guide wire can be grasped clearly) (claims 3 and 13).
Regarding claims 5 and 15, Baek in view of Uehara discloses all limitations of claims 1 and 11, respectively, as discussed above, and Baek further discloses:
wherein the heart-cycle data includes ECG values (Fig. 4: 410 and [0059]-[0060]: ECG signal).
Regarding claims 9-10 and 19-20, Baek in view of Uehara discloses all limitations of claims 1 and 11, respectively, and Baek further discloses:
the one or more captured images identified from the set of captured images and the live images are each captured during a corresponding portion of a heart cycle (Fig. 7: t1 and t2; [0076]-[0078]: acquire specific viewpoint information t1 corresponding to real-time viewpoint information t2 of the X-ray fluoroscopy image among the plurality of viewpoint information corresponding to the plurality of angiographic images).
Baek does not disclose:
replacing one or more of the live images with the one or more captured images.
In the same field of displaying previously captured and live images together, Uehara, however, teaches:
replacing one or more of the live images with the one or more captured images (Fig. 3C; [0053]: replace the part corresponding to the ROI for the live image, out of the first X-ray image data, with the second X-ray image data whose cardiac time phases are same).
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 Baek’s method/system of displaying angiograms and fluoroscopic images to include Uehara’s method of replacing one or more of the live images with the one or more captured images. One of ordinary skill in the art would have combined the elements as claimed, and the combination would have yielded a reasonable expectation of success, since both Baek and Uehara are directed to acquiring two sets of images and related heart cycle data and displaying the two sets of images together based on a heart cycle data. The motivation for the combination would have been to allow “As a result, composite images, whose regions outside the ROI are the previously acquired first X-ray images and regions inside the ROI are the second X-ray images acquired in real time, are dynamically displayed as a moving image”, as taught by Uehara ([0054]).
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Baek in view of Uehara, as applied to claims 1 and 11 above, respectively, and further in view of Takahashi et al. (US Patent Pub No. 2019/0087955, provided by the Applicant in the IDS of 19 Sep 2024) - hereinafter referred to as Takahashi.
Regarding claims 4 and 14, Baek in view of Uehara discloses all limitations of claims 1 and 11, respectively, as discussed above, as discussed above, and Baek discloses:
wherein the heart-cycle data includes ECG values (Fig. 4: 410 and [0059]-[0060]: ECG signal).
Baek does not disclose:
wherein the heart-cycle data includes aortic (AO) pressure values.
In the same field of acquiring images and heart cycle data, Takahashi, however, teaches:
acquiring a heart-cycle data including aortic pressure values ([0087]: measure aortic pressure measurement value for fractional flow rate (FFR); [0090]: angiography performed including measuring pressure (FFR)).
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 Baek’s method/system of acquiring electrocardiogram (ECG) data during angiography and fluoroscopy to include Takahashi’s method of acquiring ECG and aortic pressure values. One of ordinary skill in the art would have combined the elements as claimed, and the combination would have yielded a reasonable expectation of success, since both Baek and Takahashi are directed to acquiring images and related heart cycle data. The motivation for the combination would have been to allow “the presence or absence of the vascular stenosis portion is determined based on evaluation of lowering of the blood flow rate due to the stenosis site”, as taught by Takahashi ([0075]).
Claims 6-8 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Baek in view of Uehara, as applied to claims 1 and 11 above, respectively, and further in view of Dascal et al. (US Patent Pub No. 2014/0270436, provided by the Applicant in the IDS of 19 Sep 2024) - hereinafter referred to as Dascal.
Regarding claims 6-8 and 16-18, Baek in view of Uehara discloses all limitations of claims 1 and 11, respectively, as discussed above, and Baek further discloses:
wherein acquiring the set of captured images includes capturing the set of captured images (Fig. 4: 420 and 410 and [0055]-[0049]: image acquirer 320 captures angiography images 420; Fig. 5 and [0063]: angiographic images to acquire shape information of blood vessels such as contours; [0059]: acquire and store a plurality of viewpoint information corresponding to the angiography images 420 of the plurality of frames 1 to 11, respectively).
Baek does not disclose”
while capturing the set of captured images, intravascularly imaging one of the one or more blood vessels with an intravascular probe having one or more opaque markers, wherein intravascularly imaging the subject generates a set of intravascular image frames (claim 6); or
the one or more processors configured to control an intravascular probe having one or more opaque markers, so as to generate a set of intravascular image frames along with the set of captured images (claim 16); and
co-registering the set of intravascular image frames and the set of captured images (claims 7-8 and 17-18); and
displaying at least a subset of the set of intravascular image frames along with one or more of the live images (claims 8 and 18).
In the same field of acquiring images and heart cycle data, Dascal, however, teaches:
intravascularly imaging a blood vessel ([0076]-[0077]: angiographic data was obtained while an OCT pullback was performed) using an intravascular probe having one or more opaque markers ([0075]: OCT probe include three radiopaque marker bands), wherein intravascularly imaging the subject generates a set of intravascular image frames (Fig. 15 and [0078]-[0079]: OCT image); or
controlling an intravascular probe having one or more opaque markers ([0076]-[0077]: angiographic data was obtained while an OCT pullback was performed; [0075]: OCT probe include three radiopaque marker bands), so as to generate a set of intravascular image frames along with the set of captured images (Fig. 15 and [0078]-[0079]: OCT image); and
co-registering the set of intravascular image frames and the set of captured images ([0070] and Fig. 15); and
displaying at least a subset of a set of intravascular image frames along with one or more of the live images (Fig. 3A and [0077]-[0079]: upper right panel shows angiography image data obtained while OCT pullback was performed and OCT image on upper left panel; Fig. 3B and [0083]).
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 Baek’s method/system of displaying angiograms to include Dascal’s method of intravascularly imaging one of the blood vessels with an intravascular probe having one or more opaque markers or controlling an intravascular probe having one or more opaque markers to generate a set of intravascular image frames along with the set of captured images; co-registering the set of intravascular image frames and the set of captured images; and displaying at least a subset of a set of intravascular image frames along with one or more of the live images. One of ordinary skill in the art would have combined the elements as claimed, and the combination would have yielded a reasonable expectation of success, since both Baek and Dascal are directed to acquiring images and related heart cycle data. The motivation for the combination would have been to allow “Intravascular imaging technologies such as optical coherence tomography (OCT) and acoustic technologies such as intravascular ultrasound (IVUS) and others are also valuable tools that can be used in lieu of or in combination with fluoroscopy to obtain high-resolution data regarding the condition of the blood vessels for a given subject”, as taught by Dascal ([0002]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 12-19 of U.S. Patent No. 12127874 – hereinafter referred to as ‘874.
Regarding claim 1 of instant application, claim 1 of ‘874 recites a method of displaying sets of radiological images of one or more blood vessels of a subject comprising: acquiring, by one or more processors, a first set of radiological images of the subject captured during a first time period …; correlating (or “associating” in claim 1 of instant application), by the one or more processors, subsets of the first set of radiological images with subsets of the first set of time-varying data; acquiring, by the one or more processors, a second set of subject radiological images of the subject captured during a second time period … wherein the second set of radiological images are live radiological images; identifying, by the one or more processors, image frames from the first set of radiological images that corresponds to a subset of the second set of time-varying data; generating, by the one or more processors, a live interlaced video that includes the identified image frames from the first set of radiological images interlaced between a plurality of live image frames from the second set of radiological images based on the identified image frames corresponding to the subset of the second set of time-varying data (or “wherein the one or more captured images are added in addition to the live images, by being placed between the live images based on the live heart-cycle data and the portion of the heart-cycle data for which the one or more images have been associated” in claim 1 of instant application); and providing for display, by the one or more processors, the live interlaced video so that the live interlaced video switches between the identified image frames from the first set of radiological images and the plurality of live image frames from the second set of radiological images a plurality of times per second (or “a series of the live images of the one or more blood vessels with the one or more captured images added to the series of the live images by appearing between the live images within the series” in claim 1 of instant application). Therefore, although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 11 of the instant application, claim 12 of ‘874 recites a system for displaying sets of radiological images of one or more blood vessels of a subject comprising: a memory for storing image data and time-varying data that corresponds to a heart cycle of a subject; and one or more processors in communication with the memory so as to be able to acquire the image data and time-varying data, … acquire a first set of radiological images of the subject captured during a first time period and a first set of time-varying data that corresponds to a heart cycle of the subject during the first time period; correlate (or “associate” in claim 11 of the instant application) subsets of the first set of radiological images with subsets of the first set of time-varying data; acquire a second set of radiological images of the subject captured during a second time period and a second set of time-varying data that corresponds to the heart cycle of the subject acquired during the second time period (the second set of radiological images are assumed to be live as later in claim 12 recites “generate a live interlaced video” based on the second set of radiological images of the subject); correlate the first set of time-varying data with the second set of time-varying data; identify image frames from the first set of radiological images that correspond to a subset of the second set of time-varying data; and generate a live interlaced video that includes the identified image frames from the first set of radiological images interlaced between a plurality of live image frames from the second set of radiological images based on the identified image frames corresponding to the subset of the second set of time-varying data (or “wherein the one or more captured images are added in addition to the live images, by being placed between the live images based on the live heart-cycle data and the portion of the heart-cycle data for which the one or more images have been associated “ in claim 11 of the instant application); and provide for display the live interlaced video so that the live interlaced video switches between the identified image frames from first set of radiological images and the plurality of live image frames from the second set of radiological images a plurality of times per second. Therefore, although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of ‘874 in view of Dascal.
Regarding claims 17-18 of the instant application, claim 17 of ‘874 recites all limitations of claim 17 of instant application, but does not recite:
wherein the one or more processors are further configured to co-register the set of intravascular image frames and the set of captured images (claims 17-18); and
wherein the one or more processors are further configured to provide for display at least a subset of the set of intravascular image frames along with one or more of the live image (claim 18).
In the same field of acquiring images and heart cycle data, Dascal, however, teaches:
co-registering the set of intravascular image frames and the set of captured images ([0070] and Fig. 15); and
displaying at least a subset of a set of intravascular image frames along with one or more of the live image (Fig. 3A and [0077]-[0079]: upper right panel shows angiography image data obtained while OCT pullback was performed and OCT image on upper left panel; Fig. 3B and [0083]).
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 claim 17 of ‘874 to include Dascal’s method of co-registering the set of intravascular image frames and the set of captured images; and displaying at least a subset of a set of intravascular image frames along with one or more of the live images. One of ordinary skill in the art would have combined the elements as claimed, and the combination would have yielded a reasonable expectation of success, since both ‘874 and Dascal are directed to acquiring images and related heart cycle data. The motivation for the combination would have been to allow “Intravascular imaging technologies such as optical coherence tomography (OCT) and acoustic technologies such as intravascular ultrasound (IVUS) and others are also valuable tools that can be used in lieu of or in combination with fluoroscopy to obtain high-resolution data regarding the condition of the blood vessels for a given subject”, as taught by Dascal ([0002]).
The following is the mapping between the claims of instant application and the claims of ‘874:
Claims of Instant Application
Claims of ‘874
1
1
2
2
3
3
4
4
5
5
6
6
7
7
8
8
9
9
10
10
11
12
12
13
13
14
14
15
15
16
16
17
17
17 + Dascal
18
17+ Dascal
19
18
20
19
.
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.
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/Y.C./Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 04/02/2026