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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference Numeral “39” shown in Figure 8.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 8-11, and 13-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kunio (U.S. Pub. No. 2019/0029624).
Re claims 1, 14 and 16: Kunio disclose a method for providing a result dataset (i.e., “method for processing angiography image data by using an imaging catheter path that is directly detected from the angiography data as a co-registration path or using detected marker locations from the angiography data to generate a co-registration path”, Abstract), the method comprising/a provision unit (i.e., “imaging system 10”, Paragraph [0036]) for providing a result dataset, the provision unit comprising:
a processor configured to (i.e., “image processor 40”, Paragraph [0036])/in a non-transitory computer-readable storage medium that stores instructions executable by one or more processors to provide a result dataset (i.e., “Embodiment(s) of the present disclosure may also be realized by a computer of a system or apparatus that reads out and executes computer executable instructions (e.g., one or more programs) recorded on a storage medium (which may also be referred to more fully as a “non-transitory computer-readable storage medium”)”, Paragraph [0096]), the instructions comprising:
capturing/capture a vessel dataset (i.e., “intravascular imaging system 30 of the imaging system 10 includes a console 32, a catheter 38 and a patient interface unit 37 that connects between the catheter 38 and the console 32 for acquiring intravascular image frames”, Paragraph [0037]), wherein the vessel dataset has time-resolved images of at least one vessel section of an examination object (i.e., “patient 28”, Paragraph [0036]) in a number of physiological phases (i.e., “The imaging pullback procedure obtains images of the blood vessel. The imaging pullback path may represent the co-registration path which may be a region of interest or a targeted region of the vessel”, Paragraph [0037]; and Paragraphs [0044]-[0045]);
capturing/capture an object dataset (i.e., “angiography data obtained from the angiography system 20”, Paragraph [0041]), wherein the object dataset has an image of a medical object (i.e., “catheter 38”, Paragraph [0041]) in the examination object in at least one matching physiological phase of the number of physiological phases (i.e., “angiography data such as angiography image frames are acquired simultaneous to the acquisition of intravascular image frames”, Paragraph [0041]);
identifying/identify in each case of a corresponding image in the vessel dataset for the images of the object dataset with matching physiological phase (i.e., “detecting radiopaque marker locations for each angiography image frame. The detection of the radiopaque marker locations may occur after the angiography data is imported. Next, the co-registration path is generated after the radiopaque marker locations are detected for the angiography data. After generating the co-registration path the image processor may determine the acquisition locations of the intravascular image frames with respect to the co-registration path and the detected radiopaque marker location”, Paragraph [0046]); and
providing/provide the result dataset, the providing of/the processor being configured to provide the result dataset comprising at least partial overlaying, mixing, or overlaying and mixing of the images of the object dataset with the corresponding images of the vessel dataset (i.e., “the angiography image frame and the intravascular image frame may be displayed on the monitor with overlaying the co-registration path and an artificial indicator representative of the acquisition locations of the intravascular image frames on the displayed angiography image frame. The displayed angiography image frame and intravascular image frame may be changed within the acquired angiography data and the intravascular data, along with the overlaying co-registration path and co-registration location. Both the angiography image frame and the intravascular image frame may appear as video that plays on the GUI”, Paragraph [0046]).
Re claim 2: Kunio disclose wherein the object dataset has time-resolved images of the medical object in the examination object in a number of physiological phases (i.e., “cardiac phase information is evaluated based on the length of the entire cardiac cycle (L). The system may determine where along L a selected angiography image frame is acquired to determine the length of the cardiac cycle for the selected angiography image frame (I)”, Paragraph [0050]), wherein a corresponding image in the vessel dataset is identified in each case for each of the images of the object dataset with matching physiological phase (i.e., “if it is determined that there is contrast media in the targeted region of the blood vessel of the selected angiography image frame (Yes in step S104), the process proceeds to step S114. In step S114, the vessel contour of the targeted region and radiopaque marker are detected for the selected angiography image frame. Following step S114, the detected vessel contour, the detected radiopaque marker and the cardiac phase information associated with the selected angiography image frame are saved”, Paragraph [0056]).
Re claim 8: Kunio disclose wherein capturing the vessel dataset comprises capturing a fill dataset in a fill phase (i.e., “intravascular imaging pullback procedure which occurs after the contrast media reaches the targeted region of the patient”, Paragraph [0044]), wherein capturing the object dataset comprises capturing an initial object dataset in an object phase (i.e., “first group of angiography image frames may include those angiography image frames without the contrast media in the targeted region of the targeted blood vessel”, Paragraph [0061]), wherein the fill dataset and the initial object dataset each have an image of a common examination region of the examination object in at least one matching physiological phase (i.e., “a first intravascular image frame is selected. Next, in step S506 it is determined whether there is a corresponding angiography image frame based on the timestamp associated with the selected intravascular image frame”, Paragraph [0074]), wherein the common examination region comprises the at least one vessel section (i.e., “the contrast media reaches the targeted region”, Paragraph [0044]), wherein, in the fill phase, a contrast is arranged in the at least one vessel section and is depicted in the fill dataset (i.e., “The intravascular image frames are acquired when the contrast media reaches the targeted region of the patient”, Paragraph [0045]), wherein the medical object is arranged in the object phase in the common examination region and is depicted in the initial object dataset (i.e., “The angiography data including angiography image frames are acquired when an X-ray is on until the X-ray is off. The acquisition of the angiography image frames may start before the contrast media reaches the targeted region of the patient. It is only necessary to acquire the angiography data until the third event where the intravascular imaging pullback procedure is completed”, Paragraph [0045]), and wherein the result dataset is provided by at least partial overlaying, mixing, or overlaying and mixing of the images of the initial object dataset with the corresponding images of the fill dataset (See for example, Paragraphs [0046], and [0079]-[0080]).
Re claim 9: Kunio disclose wherein the physiological phases comprise various phases of a breath movement, heart movement, or breath movement and heart movement of the examination object (i.e., “electrocardiography (ECG) device 60 for recording the electrical activity of the heart over a period of time using electrodes placed on the skin of the patient 28”, Paragraph [0040]).
Re claim 10: Kunio disclose wherein the medical object comprises a diagnostic, surgical, or diagnostic and surgical instrument, an implant, or a combination thereof (i.e., “catheter 38”, Paragraph [0037]).
Re claim 11: Kunio disclose wherein identifying the corresponding image in the vessel dataset in each case for the images of the object dataset with matching physiological phase is based on a further similarity metric that assesses a similarity of images of the vessel dataset with images of the object dataset (i.e., “a first intravascular image frame is selected. Next, in step S506 it is determined whether there is a corresponding angiography image frame based on the timestamp associated with the selected intravascular image frame. Initially the system may search the intravascular image frames that have the angiography image frames obtained at about the same time using the timestamps of both the intravascular image frame and the angiography image frame”, Paragraph [0074]).
Re claim 13: Kunio disclose further comprising receiving a physiological movement signal having information about a current physiological phase of the examination object (i.e., “electrocardiography (ECG) device 60 for recording the electrical activity of the heart over a period of time”, Paragraph [0040]), wherein the vessel dataset, the object dataset, or the vessel dataset and the object dataset are captured depending on the physiological movement signal (i.e., “angiography data may also include cardiac phase information from the ECG 60 of FIG. 1. In particular each angiography image frame may include a cardiac phase signal value associated therewith according to time when the angiography image frame was acquired”, Paragraph [0051]).
Re claim 15: Kunio disclose a medical imaging device (i.e., “imaging system 10”, Paragraph [0036]) comprising:
a provision unit for providing a result dataset (i.e., “imaging system 10 for generating an imaging catheter path based on either a directly detected location of a radiopaque marker on the imaging catheter or a regression line representing the imaging catheter path by using an angiography image frame that is simultaneously acquired during intravascular imaging pullback”, Paragraph [0036]), the provision unit comprising:
a processor configured to (i.e., “image processor 40”, Paragraph [0036]):
capture a vessel dataset (i.e., “intravascular imaging system 30 of the imaging system 10 includes a console 32, a catheter 38 and a patient interface unit 37 that connects between the catheter 38 and the console 32 for acquiring intravascular image frames”, Paragraph [0037]), wherein the vessel dataset has time-resolved images of at least one vessel section of an examination object (i.e., “patient 28”, Paragraph [0036]) in a number of physiological phases (i.e., “The imaging pullback procedure obtains images of the blood vessel. The imaging pullback path may represent the co-registration path which may be a region of interest or a targeted region of the vessel”, Paragraph [0037]; and Paragraphs [0044]-[0045]);
capture an object dataset (i.e., “angiography data obtained from the angiography system 20”, Paragraph [0041]), wherein the object dataset has an image of a medical object (i.e., “catheter 38”, Paragraph [0041]) in the examination object in at least one matching physiological phase of the number of physiological phases (i.e., “angiography data such as angiography image frames are acquired simultaneous to the acquisition of intravascular image frames”, Paragraph [0041]);
identify in each case of a corresponding image in the vessel dataset for the images of the object dataset with matching physiological phase (i.e., “detecting radiopaque marker locations for each angiography image frame. The detection of the radiopaque marker locations may occur after the angiography data is imported. Next, the co-registration path is generated after the radiopaque marker locations are detected for the angiography data. After generating the co-registration path the image processor may determine the acquisition locations of the intravascular image frames with respect to the co-registration path and the detected radiopaque marker location”, Paragraph [0046]); and
provide the result dataset, the processor being configured to provide the result dataset comprising the processor being configured to at least partially overlay, mix, or overlay and mix the images of the object dataset with the corresponding images of the vessel dataset (i.e., “the angiography image frame and the intravascular image frame may be displayed on the monitor with overlaying the co-registration path and an artificial indicator representative of the acquisition locations of the intravascular image frames on the displayed angiography image frame. The displayed angiography image frame and intravascular image frame may be changed within the acquired angiography data and the intravascular data, along with the overlaying co-registration path and co-registration location. Both the angiography image frame and the intravascular image frame may appear as video that plays on the GUI”, Paragraph [0046]).
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.
Claims 3, 4, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Kunio in view of Langan et al. (U.S. Pub. No. 2016/0029987). The teachings of Kunio have been discussed above.
As to claim 3, Kunio does not explicitly disclose wherein capturing the vessel dataset comprises capturing a first mask dataset in a first mask phase and of a fill dataset in a fill phase, wherein the first mask dataset and the fill dataset each have time-resolved images of a common examination region of the examination object in matching physiological phases, wherein the common examination region comprises the at least one vessel section, wherein, in the fill phase, a contrast is arranged in the at least one vessel section and is depicted in the fill dataset, and wherein the vessel dataset is provided as a difference between images of the fill dataset and the first mask dataset with matching physiological phase in each case.
Langan et al. teaches capturing the vessel dataset comprises capturing a first mask dataset in a first mask phase and of a fill dataset in a fill phase (i.e., “the examination begins at t0 120, at which time the gantry motion begins, rotating an X-ray source and detector about the patient. The gantry spins for the duration of an initial spin 122, during which a set of mask data 124 is acquired … contrast may continue throughout the acquisition of contrast image data, as described in greater detail below. Once the desired degree of opacification exists within the target vasculature, the gantry is put in motion once again at t2 136 to rotate the X-ray source and detector about the patient (i.e., additional or contrast spin 138), during which a set of contrast data 140 is acquired”, Paragraph [0042]), wherein the first mask dataset and the fill dataset each have time-resolved images of a common examination region of the examination object in matching physiological phases (i.e., “Physiologic monitoring equipment may be employed for use in coordination of the acquisition, administration of the contrast bolus, and/or the reconstruction processing”, Paragraph [0045]), wherein the common examination region comprises the at least one vessel section (i.e., “vasculature of interest”, Paragraph [0045]), wherein, in the fill phase, a contrast is arranged in the at least one vessel section and is depicted in the fill dataset (i.e., “the contrast data 140 represents the data corresponding to the spin 138 of the gantry while the target vasculature is opacified by contrast”, Paragraph [0042]), and wherein the vessel dataset is provided as a difference between images of the fill dataset and the first mask dataset with matching physiological phase in each case (i.e., “The mask images are then subtracted (block 202) from the corresponding contrast images to generate a respective difference image 204 for each image in the sequence”, Paragraph [0050]).
Kunio and Langan et al. are analogous art because they are from the field of digital image processing for medical imaging analysis.
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify Kunio by incorporating the capturing the vessel dataset comprises capturing a first mask dataset in a first mask phase and of a fill dataset in a fill phase, wherein the first mask dataset and the fill dataset each have time-resolved images of a common examination region of the examination object in matching physiological phases, wherein the common examination region comprises the at least one vessel section, wherein, in the fill phase, a contrast is arranged in the at least one vessel section and is depicted in the fill dataset, and wherein the vessel dataset is provided as a difference between images of the fill dataset and the first mask dataset with matching physiological phase in each case, as taught by Langan et al.
The suggestion/motivation for doing so would have been to build a contrast-enhanced volume using a mask dataset and a contrast dataset.
Therefore, it would have been obvious to combine Langan et al. with Kunio to obtain the invention as specified in claim 3.
As to claim 4, Kunio teaches wherein capturing the object dataset comprises capturing an initial object dataset in an object phase (i.e., “The angiography data including angiography image frames are acquired when an X-ray is on until the X-ray is off”, Paragraph [0045]), wherein the initial object dataset has an image of the common examination region of the examination object in the at least one matching physiological phase (i.e., “the system chooses one angiography image frame from the group of angiography image frames with the contrast media and finds an angiography image frame with the same cardiac phase from the angiography image frames without the contrast media”, Paragraph [0063]), wherein the medical object is arranged in the object phase in the common examination region and is depicted in the initial object dataset (i.e., “The angiography image frame 70 includes an imaging catheter path 71 that is detected by the image processor”, Paragraph [0061]; and “The angiography image frame 72 includes the detected vessel contours 74 as well the detected radiopaque marker 73”, Paragraph [0062]), and wherein the object dataset is provided as a difference between images of the initial object dataset and a first mask dataset with matching physiological phase in each case (See for example, “After the processes of detecting and saving for entire angiography image frames, the system chooses one angiography image frame from the group of angiography image frames with the contrast media and finds an angiography image frame with the same cardiac phase from the angiography image frames without the contrast media. Then, the imaging catheter path 71 detected from the selected angiography image frame 70 is overlaid on the selected angiography image frame 72 as shown in the angiography image frame 75 including the two overlaid angiography image frames (70, 72). The angiography image frame 75 is used to determine whether the detected imaging catheter path 71 is located within the detected vessel contours to make sure the detected imaging catheter path can be a representative line of the vessel's longitudinal direction”, Paragraph [0063]).
As to claim 7, Langan et al. teaches wherein the respective images to be subtracted are registered with one another (i.e., “The spin acquisition acquires projection data as the gantry rotates about the patient. A spin can take 3 to 20 seconds to acquire the data and a pause (or dead time) must be incurred before a spin can be repeated as the X-ray source is repositioned to its initial or start position to allow different spin acquisitions to be spatially registered with respect to the patient”, Paragraph [0041]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kunio in view of Langan et al. as applied to claim 3 above, and further in view of Eck et al. (U.S. Pub. No. 2006/0120581). The teachings of Kunio and Langan et al. have been discussed above.
As to claim 6, Kunio and Langan et al. do not explicitly disclose wherein the respective images to be subtracted are identified with the respective matching physiological phase with the aid of a similarity metric that assesses a similarity of images of various datasets.
Eck et al. teaches respective images to be subtracted (i.e., Paragraph [0057]) are identified with the respective matching physiological phase (See for example, Paragraph [0044]) with the aid of a similarity metric that assesses a similarity of images of various datasets (See for example, “In order to find an image from an extreme phase of respiration from among such previous images, for each previous image its similarity measures relative to a series of sequential images (over at least two respiratory cycles) can be calculated experimentally”, Paragraph [0046]).
Kunio, Langan et al. and Eck et al. are analogous art because they are from the field of digital image processing for medical imaging analysis.
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to further modify Kunio and Langan et al. by incorporating the respective images to be subtracted are identified with the respective matching physiological phase with the aid of a similarity metric that assesses a similarity of images of various datasets, as taught by Eck et al.
The suggestion/motivation for doing so would have been to enable the association of images in matching physiological phases within millimeter or sub-millimeter range.
Therefore, it would have been obvious to combine Eck et al. with Kunio and Langan et al. to obtain the invention as specified in claim 6.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kunio in view of Aben et al. (EP 3884868). The teachings of Kunio have been discussed above.
As to claim 12, Kunio does not explicitly disclose wherein providing the result dataset comprises a registration of the images of the object dataset with the corresponding images of the vessel dataset.
Aben et al. teaches providing the result dataset comprises a registration of the images of the object dataset with the corresponding images of the vessel dataset (See for example, “After the correct x-ray angiographic image frame is selected, the cumulated image is superimposed onto the selected x-ray angiographic frame as for example by using registration techniques. The cumulated image (2008 or 2011) represents the segmented radiopaque wire section of each selected phase within the successive cardiac cycles and represents the pullback of the intravascular wire. Since the intravascular wire is located inside the vessel, the cumulative image (2008 or 2011) must be inside the vessel and hence can be used for image registration as the vessel location. Note that when using an image frame of the same cardiac phase as chosen to detect the wire positions in step 1901, the registration becomes easier since cardiac motion is already reduced”, Paragraph [0078]).
Kunio and Aben et al. are analogous art because they are from the field of digital image processing for medical imaging analysis.
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify Kunio by incorporating the providing of the result dataset comprises a registration of the images of the object dataset with the corresponding images of the vessel dataset, as taught by Aben et al.
The suggestion/motivation for doing so would have been to aid a physician in a good decision making and avoid exposing the subject to risks that are not necessary.
Therefore, it would have been obvious to combine Aben et al. with Kunio to obtain the invention as specified in claim 12.
Allowable Subject Matter
Claim 5 is 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.
The following is a statement of reasons for the indication of allowable subject matter: with respect to claim 5, the closest prior art made of record fails to disclose, teach, and/or suggest, inter alia, the method steps of claim 3 and further comprising the
capturing the object dataset comprises capturing a second mask dataset in a second mask phase and an initial object dataset in an object phase, wherein the second mask dataset and the initial object dataset each have an image of a common examination region of the examination object in at least one matching physiological phase, wherein the medical object is arranged in the object phase in the common examination region and in the initial object dataset, and wherein the object dataset is provided as a difference between images of the initial object dataset and of the second mask dataset with matching physiological phase in each case, as claimed.
Conclusion
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/JOSE M TORRES/Examiner, Art Unit 2664 05/01/2026
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