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 .
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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.
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Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 18 of U.S. Patent Publication: 12,087,000 in which the issue fee has already been paid. Although the claims are not identical, they are not patently distinct from each other because they recite substantially the same limitations in slight broader verbiage.
Summary of double patenting claims (the similarities are bolded; differences are italicized)
Instant application
US20220165075A1
1. A method for vascular imaging co-registration, the method comprising:
obtaining extravascular imaging data of a portion of a blood vessel, the extravascular imaging data including:
an extravascular image showing an intravascular imaging device disposed within the vessel, with an imaging element of the intravascular imaging device disposed at a starting location for a translation procedure during which the imaging element is translated within the blood vessel from the starting location to an ending location;
an extravascular contrast image showing the portion of the blood vessel with contrast and showing a visualized anatomical landmark;
obtaining intravascular imaging data from the intravascular imaging device during the translation procedure, the intravascular imaging data including one or more intravascular images showing a detected anatomical landmark;
marking the starting location and the ending location of the imaging element on the extravascular imaging data;
marking a predicted location of the detected anatomical landmark on the extravascular imaging data; and
aligning the predicted location of the detected anatomical landmark with the visualized anatomical landmark.
1. A method for vascular imaging co-registration, the method comprising:
obtaining extravascular imaging data of a portion of a blood vessel, the extravascular imaging data including:
an extravascular image showing an intravascular imaging device disposed within the vessel, with an imaging element of the intravascular imaging device disposed at a starting location for a translation procedure during which the imaging element is translated within the blood vessel from the starting location to an ending location, wherein during the translation procedure, the imaging element is translated within the blood vessel from the starting location to the ending location at a known speed;
an extravascular contrast image showing the portion of the blood vessel with contrast and showing a visualized anatomical landmark;
obtaining intravascular imaging data from the intravascular imaging device during the translation procedure, the intravascular imaging data including one or more intravascular images showing a detected anatomical landmark;
marking the starting location and the ending location of the imaging element on the extravascular imaging data;
marking a predicted location of the detected anatomical landmark on the extravascular imaging data; and
aligning the predicted location of the detected anatomical landmark with the visualized anatomical landmark;
calculating a path on the extravascular imaging data that the imaging element of the intravascular imaging device will travel during the translation procedure from the starting location to the ending location; and
determining the predicted location of the detected anatomical landmark on the extravascular imaging data using the known speed that the imaging element is translated within the blood vessel from the starting location to the ending location.
Instant application
US20220165075A1
1. 1. A method for vascular imaging co-registration, the method comprising:
obtaining extravascular imaging data of a portion of a blood vessel, the extravascular imaging data including:
an extravascular image showing an intravascular imaging device disposed within the vessel, with an imaging element of the intravascular imaging device disposed at a starting location for a translation procedure during which the imaging element is translated within the blood vessel from the starting location to an ending location;
an extravascular contrast image showing the portion of the blood vessel with contrast and showing a visualized anatomical landmark;
obtaining intravascular imaging data from the intravascular imaging device during the translation procedure, the intravascular imaging data including one or more intravascular images showing a detected anatomical landmark;
marking the starting location and the ending location of the imaging element on the extravascular imaging data;
marking a predicted location of the detected anatomical landmark on the extravascular imaging data; and
aligning the predicted location of the detected anatomical landmark with the visualized anatomical landmark.
1. A method for vascular imaging co-registration, the method comprising:
obtaining extravascular imaging data of a portion of a blood vessel, the extravascular imaging data including:
an extravascular image showing an intravascular imaging device disposed within the vessel, with an imaging element of the intravascular imaging device disposed at a starting location for a translation procedure during which the imaging element is translated within the blood vessel from the starting location to an ending location, wherein during the translation procedure, the imaging element is translated within the blood vessel from the starting location to the ending location at a known speed;
an extravascular contrast image showing the portion of the blood vessel with contrast and showing a visualized anatomical landmark;
obtaining intravascular imaging data from the intravascular imaging device during the translation procedure, the intravascular imaging data including one or more intravascular images showing a detected anatomical landmark;
marking the starting location and the ending location of the imaging element on the extravascular imaging data;
marking a predicted location of the detected anatomical landmark on the extravascular imaging data;
aligning the predicted location of the detected anatomical landmark with the visualized anatomical landmark; and
calculating a path on the extravascular imaging data that the imaging element of the intravascular imaging device will travel during the translation procedure from the starting location to the ending location;
wherein marking the predicted location of the detected anatomical landmark on the extravascular imaging data includes:
calculating a path on the extravascular imaging data that the imaging element of the intravascular imaging device will travel during the translation procedure from the starting location to the ending location; and
determining the predicted location of the detected anatomical landmark on the extravascular imaging data using the known speed that the imaging element is translated within the blood vessel from the starting location to the ending location.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-16, and 19-20 are rejected are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without integration into a practical application or recitation of significantly more.
Independent claim 1 is directed to one of the four statutory categories of eligible subject matter; thus, the claims pass Step 1 of the Subject Matter Eligibility Test (See flowchart in MPEP 2106).
Step 2A, prong 1 analysis:
The independent claims are directed to obtaining extravascular imaging data of a portion of a blood vessel, the extravascular imaging data including an extravascular image showing an intravascular imaging device disposed within the vessel, with an imaging element of the intravascular imaging device disposed at a starting location for a translation procedure during which the imaging element is translated within the blood vessel from the starting location to an ending location; an extravascular contrast image showing the portion of the blood vessel with contrast and showing a visualized anatomical landmark, obtaining intravascular imaging data from the intravascular imaging device during the translation procedure, the intravascular imaging data including one or more intravascular images showing a detected anatomical landmark, marking the starting location and the ending location of the imaging element on the extravascular imaging data, marking a predicted location of the detected anatomical landmark on the extravascular imaging data, and aligning the predicted location of the detected anatomical landmark with the visualized anatomical landmark.
Each of the above steps can be performed mentally. In particular, a doctor has the ability to d vascular imaging co-registration when evaluating a patient; this advanced technique—often used in cardiology, neurosurgery, and vascular surgery—allows specialists to overlay functional, cross-sectional views (like intravascular ultrasound or optical coherence tomography) onto broad anatomical maps (like angiograms or fluoroscopy) in real-time; steps such as obtaining extravascular and intravascular data, disposing an imaging device inside the patients’ blood vessels, and doing a translation procedure while observing the imaging on a display to find anatomical landmarks in the blood vessel (marking locations accordingly) are all standard procedure for doctor’s evaluating patients; Doctors synchronize intravascular ultrasound (IVUS) or OCT data with angiograms; this connects an exact cross-sectional view of a vessel (showing plaque buildup or vessel diameter) with its precise geographic location along the artery; therefore, this process can all be done mentally.
As such, the description in independent claim 1 is an abstract idea – namely, a mental process. Accordingly, the analysis under prong one of step 2A of the Subject Matter Eligibility Test does not result in a conclusion of eligibility (See flowchart in MPEP 2106).
Additional elements:
The additional element recited in independent claim 1 is an intravascular imaging device.
Step 2A, prong 2 analysis:
The above-identified additional elements do not integrate the judicial exception into a practical application.
Each of the other additional elements (intravascular imaging device) amounts to merely using different devices as tools to perform the claimed mental process. Implementing an abstract idea on a computer or using known generic devices does not integrate a judicial exception into a practical application (See MPEP 2106.05(f)).
Moreover, the additional elements of the claims do not recite an improvement in the functioning of a computer or other technology or technical field, the claimed steps are not performed using a particular machine, the claimed steps do not effect a transformation, and the claims do not apply the judicial exception in any meaningful way beyond generically linking the use of the judicial exception to a particular technological environment (See MPEP 2106.04(d)). Therefore, the analysis under prong two of step 2A of the Subject Matter Eligibility Test does not result in a conclusion of eligibility (See flowchart in MPEP 2106).
Step 2B:
Finally, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Each of the other additional elements (intravascular imaging device) are generic computer features which perform generic computer functions that are well-understood, routine, and conventional and do not amount to more than implementing the abstract idea with a computerized system. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea).
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation, and mere implementation on a generic computer does not add significantly more to the claims. Accordingly, the analysis under step 2B of the Subject Matter Eligibility Test does not result in a conclusion of eligibility (See flowchart in MPEP 2106).
For all of the foregoing reasons, independent claim 1 does not recite eligible subject matter under 35 USC 101.
Claims 2-16 all recite aspects that are easily accomplished by a trained physician, such as using different typers of image data and video, manually marking locations in the image data, doing translation of the image device through/within the blood vessel and stopping at different locations to take data, and generating visual indicators on a computer of anatomical landmarks; therefore, this process can all be done mentally.
Therefore, dependent claims 2-16 and 19-20 recite the same abstract idea of a mental process which can be performed in the mind with the aid of pen and paper, and are therefore also rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 1-6, 8, 12, 14-16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over European Patent Application Publication No.: EP 4091536 A1 (Dascal et al.) (hereinafter Dascal), in view of U.S. Patent Application Publication No.: 2012/0172700 (Arun et al.) (hereinafter Arun).
Regarding claim 1, Dascal teaches a method for vascular imaging co-registration, the method comprising: (Dascal, abstract: “In part, the invention relates to processing, tracking and registering angiography images and elements in such images relative to images from an intravascular imaging modality such as, for example, optical coherence tomography (OCT). Registration between such imaging modalities is facilitated by tracking of a marker of the intravascular imaging probe performed on the angiography images obtained during a pullback. Further, detecting and tracking vessel centerlines is used to perform a continuous registration between OCT and angiography images in one embodiment.”)
obtaining extravascular imaging data of a portion of a blood vessel, the extravascular imaging data including: (Dascal, para. [0015]-[0017]: “The method includes generating a set of OCT image data in response to distance measurements of a blood vessel using an optical coherence tomography system, the set comprising a plurality of cross-sectional image at a plurality of positions along the blood vessel; generating a set of angiography image data, the set comprising a plurality of two dimensional images at a plurality of positions along the blood vessel; and co-registering the angiography images and OCT images based on one or more of a time stamp, a relationship between time stamps, matching of a feature in an OCT image with a feature in an angiography image, and determining a centerline for the blood vessel and using the centerline to co-register the OCT images and angiography images … The method includes generating a set of optical coherence tomography image data in response to distance measurements of the blood vessel obtained during a pullback of a probe through the blood vessel using an optical coherence tomography system, the set of OCT image data comprising a plurality of cross-sectional image at a plurality of positions along the blood vessel; generating a set of angiography image data using an angiography system during the pullback of the probe through the blood vessel using an optical coherence tomography system, the set of angiography image data comprising a plurality of two-dimensional images obtained at different points in time during the pullback; displaying a first panel comprising a first longitudinal view of the blood vessel generated using the OCT image data; and displaying a second panel comprising a frame of the angiography image data identifying the blood vessel using one or more points in the frame and a vessel centerline passing through the one or more points … co-registering the OCT image data and the angiography data using vessel centerlines to create a continuous registration of a tracked marker, wherein the tracked marker is disposed on an OCT data collection probe.”).
an extravascular image showing an intravascular imaging device disposed within the vessel, with an imaging element of the intravascular imaging device disposed at a starting location for a translation procedure during which the imaging element is translated within the blood vessel from the starting location to an ending location (Dascal, para. [0045]-[0046]; para. [0112]; FIG. 3A: “Figure 3A shows an exemplary graphic user interface configured to display multiple panels. The graphic user interface can be implemented using a computing device such as the server 50 or workstation 87 or another suitable computing device. The upper right panel shows frame angiography image data … An exemplary cross-section of the artery is shown in the upper left panel. In the upper left OCT image side branch is shown to the right of the cross-section of the data collection probe. Lower panel, which substantially spans the user interface, includes the longitudinal image of the blood vessel disposed between the distal end point and the proximal end point shown in the angiography image shown by points or cursors 3, 4”; “Tracking distal guidewire anchor point to all pullback angiography frames 170e is performed next. The proximal anchor point is detected in a single frame. The distal anchor point is also detected in a single frame. In one embodiment, each anchor point is a feature that can be easily detected in other frames by means of tracking. Next, anchor points are tracked to all frames so that each angiography frame will have two end points for vessel-centerline generation (trace).”;
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an extravascular contrast image showing the portion of the blood vessel with contrast and showing a visualized anatomical landmark; obtaining intravascular imaging data from the intravascular imaging device during the translation procedure, the intravascular imaging data including one or more intravascular images showing a detected anatomical landmark (Dascal, para. [0027]; para. [0012]: “In one embodiment, the method further includes identifying a side branch in one or more OCT images or angiography images using the co-registration table and a user interface configured to display the side branch. In one embodiment, the method further includes to set the spacing of the frames of OCT data based on the co-registration table to adjust for pullback speed changes and to display a longitudinal view in a user interface based on the spacing.”; “In one embodiment, video capture of angiography image data occurs on the OCT system. In one embodiment, a user manually designates a marker band on an angiography image. In one embodiment, the designated marker band is on an angiography image without contrast agent.”);
marking the starting location and the ending location of the imaging element on the extravascular imaging data (Dascal, para. [0112]: “Figure 5B shows a process flow 170 relating to vessel centerline generation. In one embodiment, a Hessian having a scale of 1 is applied to a frame of angiography data 170a. This application of the Hessian results in enhancements of thin ridges in the image such as the guidewire. In one embodiment, automatic detection of the guidewire and selection of an anchor point on the guidewire is performed 170c. Once the guidewire is detected, in one embodiment, the point with the highest LoG response is identified as the anchor point. Tracking distal guidewire anchor point to all pullback angiography frames 170e is performed next. The proximal anchor point is detected in a single frame. The distal anchor point is also detected in a single frame. In one embodiment, each anchor point is a feature that can be easily detected in other frames by means of tracking. Next, anchor points are tracked to all frames so that each angiography frame will have two end points for vessel-centerline generation (trace).”); and
marking a predicted location of the detected anatomical landmark on the extravascular imaging data (Dascal, para. [0017]; [0163]: “In one embodiment, the method further includes using pullback speed or pullback length to perform an iterative search to reject candidates for the tracked marker based on the possible locations for such markers based upon the pullback length and/or pullback speed.”; “using pullback speed or pullback length to perform an iterative search to reject candidates for the tracked marker based on the possible locations for such markers based upon the pullback length and/or pullback speed.”).
Dascal fails to teach
aligning detected anatomical landmark with the visualized anatomical landmark.
Arun teaches
aligning detected anatomical landmark with the visualized anatomical landmark (Arun, para. [0049]-[0050]; FIG. 3: ““In one implementation, optimal views of the medical images 404 a-b are created (or reconstructed). The images may be rotated, translated or scaled for proper viewing. In addition, the medical images 404 a-b may be created as maximum or minimum intensity projection images, multi-planar reconstruction (MPR) images, curved MPR images, summation-based, average-based or filtering-based projection images, or a combination thereof. In another implementation, the medical images 404 a-b comprise a curved planar reformat (CPR) view of the structure of interest. To create the CPR image, sagittal or coronal reformat curvilinear coordinates of the images may be spatially aligned with, for example, the coordinates of the principal bony structures of the spine (e.g., spinal canal, vertebrae, spinous processes, etc.). The optimal views may further be created by normalizing (or correcting) medical images 404 a-b to improve visualization. In the case of MR images, for instance, normalization may be performed based on the MR signal to soft-tissue intensity. In one implementation, the medical images 404 a-b are normalized by using the typical minimum and maximum signal intensity values of known soft tissue areas to rescale the signal intensity values of the rest of the image from minimum to maximum values. The medical images 404 a-b may also be scaled or coded. This allows the MR signal of marrow (or medullar) areas (e.g., bone) to be compared with the signal intensity of soft tissue areas (e.g., muscle). Other types of normalization may also be performed.”;
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As shown in FIG. 3, medical images that are visualized with anatomical landmarks; anatomical landmarks are detected via user selection for a region of interest; alignment allows for the user selection to be aligned with the detected anatomical landmarks for optimal views of the medical images; the example given is coronal reformat curvilinear coordinates of the images spatially aligned with the coordinates of the principal bony structures of the spine for proper viewing).
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify the method, as taught by Dascal, to include the step of aligning detected anatomical landmark with the visualized anatomical landmark, as taught by Arun.
The suggestion/motivation for doing so would have been that aligning the predicted location of an anatomical landmark with its visually observed location ensures diagnostic accuracy, minimizes manual annotation errors, and provides consistent spatial orientation for surgical planning.
Dascal, in view of Arun, teaches
aligning the predicted location of the detected anatomical landmark with the visualized anatomical landmark (Dascal, para. [0045]-[0046]; para. [0112]; FIG. 3A; para. [0027]; para. [0012]; para. [0015]-[0017]; Arun, para. [0049]-[0050]; FIG. 3; see rejection above; Dascal teaches identifying visual anatomical landmarks, such as side branches, in angiography images and detecting the same anatomical landmarks in OCT images, as well as registering OCT and angiography data by selecting a point on the vessel centerline through a user interface; Arun teaches the concept of aligning user selected anatomical landmarks in medical images with pre-visualized landmarks for optimal viewing of the images; when Dascal is modified by Arun there is a deviation between the anatomic landmark locations automatically predicted by the system and the anatomic landmark locations actually visible in the angiographic image, the locations are aligned for better viewing; Dascal, in view of Arun, aligns these two corresponding landmarks to eliminate the prediction error).
Therefore, it would have been obvious to combine Dascal, with Arun, to obtain the invention as specified in claim 1.
Regarding claim 2, Dascal, in view of Arun, teaches the method of claim 1, wherein the extravascular imaging data includes one or both angiographic image data and fluoroscopic image data (Dascal, para. [0056]: “The data collection system 5 includes a noninvasive imaging system such as a nuclear magnetic resonance, x-ray, computer aided tomography, or other suitable noninvasive imaging technology. As shown as a non-limiting example of such a noninvasive imaging system, an angiography system 20 such as suitable for generating cines is shown. The angiography system 20 can include a fluoroscopy system. Angiography system 20 is configured to noninvasively image the subject 10 such that frames of angiography data, typically in the form of frames of image data, are generated while a pullback procedure is performed using a probe 30 such that a blood vessel in region 25 of subject 10 is imaged using angiography in one or more imaging technologies such as OCT or IVUS, for example.”).
Regarding claim 3, Dascal, in view of Arun, teaches the method of claim 2, wherein the angiographic data is selected from one or more of two-dimensional angiographic image data; three-dimensional angiographic image data; or computer tomography angiographic image data (Dascal, para. [0016]: “generating a set of angiography image data using an angiography system during the pullback of the probe through the blood vessel using an optical coherence tomography system, the set of angiography image data comprising a plurality of two-dimensional images obtained at different points in time during the pullback; displaying a first panel comprising a first longitudinal view of the blood vessel generated using the OCT image data;”).
Regarding claim 4, Dascal, in view Arun, teaches the method of claim 1, wherein the extravascular imaging data is video including the extravascular image showing the intravascular imaging device and the extravascular contrast image showing the portion of the blood vessel with contrast (Dascal, para. [0004]; para. [0012]: “Intravascular optical coherence tomography is a catheter-based imaging modality that uses light to peer into coronary artery walls and generate images thereof for study. Utilizing coherent light, interferometry, and micro-optics, OCT can provide video-rate in-vivo tomography within a diseased vessel with micrometer level resolution. Viewing subsurface structures with high resolution using fiber-optic probes makes OCT especially useful for minimally invasive imaging of internal tissues and organs.”; “In one embodiment, the time stamps are used to give a first-order match between angiography frames and their corresponding OCT frames, such that for every OCT frame, the closest angiography frame can be located, and vice versa. In addition, time-stamped events, such as pullback start and stop, are also recorded to assist the co-registration process.”).
Regarding claim 5, Dascal, in view of Arun, teaches the method of claim 1, wherein extravascular imaging data is a series of images including the extravascular image showing the intravascular imaging device and the extravascular contrast image showing the portion of the blood vessel with contrast (Dascal, para. [0004]; para. [0012]: “Intravascular optical coherence tomography is a catheter-based imaging modality that uses light to peer into coronary artery walls and generate images thereof for study. Utilizing coherent light, interferometry, and micro-optics, OCT can provide video-rate in-vivo tomography within a diseased vessel with micrometer level resolution. Viewing subsurface structures with high resolution using fiber-optic probes makes OCT especially useful for minimally invasive imaging of internal tissues and organs.”; “In one embodiment, the time stamps are used to give a first-order match between angiography frames and their corresponding OCT frames, such that for every OCT frame, the closest angiography frame can be located, and vice versa. In addition, time-stamped events, such as pullback start and stop, are also recorded to assist the co-registration process.”).
Regarding claim 6, Dascal, in view of Arun, teaches the method of claim 1, wherein the intravascular imaging data is selected from one or more of intravascular ultrasound data and optical coherence tomography data (Dascal, para. [0002]; para. [0031]: “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.”; “In addition, in one embodiment image data is collected using optical coherence tomography probes and other related OCT components. In one embodiment image data is collected using IVUS probes and other related IVUS components.”).
Regarding claim 8, Dascal, in view of Arun, teaches the method of claim 1, further including identifying the visualized anatomical landmark on the extravascular imaging data (Dascal, para. [0027]: para. [0094]; FIG. 7A-7F: “In one embodiment, the method further includes identifying a side branch in one or more OCT images or angiography images using the co-registration table and a user interface configured to display the side branch.”; “In one embodiment, the process of generating skeletons to detect anatomic features like side branches and vessel geometry is implemented during preprocessing of the angiography images 160d. Skeletons can be used for detecting anatomical features such as main bifurcation (170l) and extrapolation point (170m). In addition, skeletons can be used for detecting and generating a smooth vessel centerline (170f). For example, skeletons can be used with the Dijkstra algorithm. The skeletons can be generated based on preprocessed Hessian images. A user selected point on an angiography image, such as the image of Figure 7A, relating to a guidewire position can be used to reduce noise and facilitate skeleton generation.”
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Regarding claim 12, Dascal, in view of Arun, teaches the method of claim 1, wherein aligning the predicted location of the detected anatomical landmark with the visualized anatomical landmark is performed automatically using software (Dascal, para. [0045]-[0046]; para. [0112]; FIG. 3A; para. [0027]; para. [0012]; para. [0015]-[0017]; Arun, para. [0049]-[0050]; FIG. 3; see rejection of claim 1 above; Dascal teaches identifying visual anatomical landmarks, such as side branches, in angiography images and detecting the same anatomical landmarks in OCT images, as well as registering OCT and angiography data by selecting a point on the vessel centerline through a user interface; Arun teaches the concept of aligning user selected anatomical landmarks in medical images with pre-visualized landmarks for optimal viewing of the images; when Dascal is modified by Arun there is a deviation between the anatomic landmark locations automatically predicted by the system and the anatomic landmark locations actually visible in the angiographic image, the locations are aligned for better viewing; Dascal, in view of Arun, aligns these two corresponding landmarks to eliminate the prediction error; this process is done automatically by software).
Regarding claim 14, Dascal, in view of Arun, teaches the method of claim 1, wherein the translation procedure is performed using an automatic translation system (Dascal, para. [0017]; para. [0060]: “In one embodiment, the method further includes using pullback speed or pullback length to perform an iterative search to reject candidates for the tracked marker based on the possible locations for such markers based upon the pullback length and/or pullback speed”; “The patient interface unit 35 includes a probe connector suitable to receive an end of the probe 30 and be optically coupled thereto. Typically, the data collection probes 30 are disposable. The PIU 35 includes suitable joints and elements based on the type of data collection probe being used. For example a combination OCT and IVUS data collection probe requires an OCT and IVUS PIU. The PIU 35 typically also includes a motor suitable for pulling back the torque wire, sheath, and optical fiber 33 disposed therein as part of the pullback procedure. In addition to being pulled back, the probe tip is also typically rotated by the PIU 35. In this way, a blood vessel of the subject 10 can be imaged longitudinally or via cross-sections. The probe 30 can also be used to measure a particular parameter such as an FFR or other pressure measurement.”).
Regarding claim 15, Dascal, in view of Arun, teaches the method of claim 1, wherein the translation procedure is a pullback (Dascal, para. [0017]: “In one embodiment, the method further includes using pullback speed or pullback length to perform an iterative search to reject candidates for the tracked marker based on the possible locations for such markers based upon the pullback length and/or pullback speed”).
Regarding claim 16, Dascal, in view of Arun, teaches the method of claim 1, wherein during the translation procedure, the imaging element is translated within the blood vessel from the starting location to the ending location at a known speed (Dascal, para. [0055]; para. [0082]: “Initially, the proximal marker band may reside near the ostium of the coronary branch, thus it is occluded by a cloud of contrast agent during the pullback. The catheter is pulled back at constant speed through the vessel. Due to different foreshortening of blood vessel segments along the pullback, the marker does not move at constant speed in the angiography image plane (2D). Furthermore, due to the cardiac motion, the marker exhibits a distinctive "sawing" motion relative to the anatomy of the vessel.”; “The FOM determination is a scoring process that is based upon one or more factors such as the quality of the detected blob (contrast or intensity of detected blob compared to that of immediate neighborhood, shape, size, etc.), the distance of the detected blob from its nominally expected position (based on pullback speed, frame rate calculations)”); and
further including: calculating a path on the extravascular imaging data that the imaging element of the intravascular imaging device will travel during the translation procedure from the starting location to the ending location (Dascal, para. [0119]; para. [0093]: “The Viterbi algorithm is configured to balance an extrinsic factor and an intrinsic factor. The extrinsic factor (marker band indications) is derived from the marker band Laplacian of the Gaussian map by resampling the map in discrete strips perpendicular to the trace, per angiography frame. The intrinsic factor is the arc-length progression over time. This intrinsic factor models the advancement of the marker band along the pullback's arc length. The basic notion is that the average pace is determined by the pullback speed, while there are penalties for deviating from this pace. This factor takes the natural "sawing" profile into account, by penalizing forward/backward motion differently.”; “The use of a skeleton or line segment based approach to generate a candidate path through the blood vessel for the data collection probe which can be used to inform centerline generation and marker tracking offers several advantages to forgoing the use of such an approach. For example, the skeleton based approach can prevent or eliminate certain centerline traces being generated that would otherwise pass through a side branch or the imaging probe catheter.”).
Regarding claim 19, Dascal, in view of Arun, the method of claim 1, further including: estimating accuracy of the imaging co-registration, (Dascal, para. [0081]: “Generating a confidence score / figure of merit (FOM) is performed using one or more software modules 1501. In one embodiment, the confidence score or (FOM) is provided to a user by graphical representation on a computer monitor, for example by providing a color-code on the X-ray or OCT image indicating regions of the OCT pullback that have high or low confidence of being co-registered. Regions of low confidence may, for example, be indicated by a red strip or bar on the X-ray image near the vessel segment where low FOM values were obtained. The FOM/Score reflects a confidence measure in the returned results. The score is in the range of [0, 1] where 0 reflects the lowest confidence and 1 reflects the highest. A FOM threshold value can be selected to define a boundary between high confidence and low confidence co-registration results. The threshold value can be chosen to give a desired sensitivity and specificity for identifying high-error locations by producing a receiver-operator curve (ROC). If low FOM values are obtained for a large portion of the frames in a given pullback, such that the overall quality of the co-registration is questionable, no co-registration results may be displayed to the user.”);
generating a visual indicator representing the estimated accuracy of the imaging co-registration, and displaying the visual indicator overlaid on the portion of the blood vessel on the extravascular imaging data (Dascal, para. [0134]: “In addition, given that a marker on the stent delivery probe can be tracked, a stimulated stent can be shown in relation to the marker on the OCT longitudinal mode or L-mode. The angiography / OCT co-registration allows cross-correlating of tissue features, lumen features and moving features such as a balloon or stent insertion to be shown in the angiography with overlays and with the display of elements such as a stent cross-section in the L-mode. If a scan of the stent is obtained as a wireframe model or is selected from a drop down menu prior to stenting, the diameter and length can be used to display the stent on the L-mode or angiography with greater accuracy. In one embodiment, bands on the OCT image and/or the angiography image showing regions to avoid stenting like side branches and a target deployment region based on stenosis / MLA calculations can be used. The angiography and OCT displays can be used to show a greater level of granularity with overlays to help a user properly position a stent within a target area. In addition, given the wireframe model of the stent and the calculated lumen areas from the OCT frames that are co-registered with the location of the stent on the angiography system, visual guidance for a stent inflation target can be provided and displayed.”).
Regarding claim 20, Dascal, in view of Arun, teaches the method of claim 1, wherein the extravascular imaging data further includes an intermediate extravascular image obtained during the translation procedure showing the intravascular imaging device disposed within the vessel with the imaging element disposed at an intermediate location during the translation procedure between the starting location the ending location; and the method further includes marking the intermediate location of the imaging element on the extravascular imaging data (Dascal, para. [0043]: “In one embodiment, a data collection probe such as an OCT probe can include three radiopaque marker bands. The distal marker located at the distal end of the probe remains stationary throughout the acquisition. The middle marker is located at the imaging core, which resides 27 mm from the distal marker before pullback. The proximal marker is located 50 mm from the imaging core and this distance remains fixed during the pullback.”).
Claims 7, 9-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Dascal, in view of Arun, and in view of U.S. Patent Application Publication No.: 2006/0241465 (Huennekens et al.) (hereinafter Huennekens).
Regarding claim 7, Dascal, in view of Arun, teaches the method of claim 1, marking the starting location and the ending location (Dascal, para. [0112]; see rejection of claim 1 above).
Dascal, in view of Arun, fails to teach
allowing a user to manually mark locations, using image pattern recognition software, or both.
Huennekens teaches
allowing a user to manually mark locations, using image pattern recognition software, or both (Huennekens, para. [0053]: “Establishing a position for the marker artifact within the field of the enhanced radiological image, based at least in part upon a radiopaque marker on the imaging catheter 20 is achievable in a variety of ways. Examples, described further herein below include: user-specified points (by clicking at a position near the marker to establish a point); image pattern recognition (automatic identification of a marker's unique signature within a field of view); and combinations of manual and automated calculations of a path.”).
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify the step of marking the starting location and the ending location, as taught by Dascal, in view of Arun, to include allowing a user to manually mark locations, using image pattern recognition software, or both, as taught by Huennekens.
The suggestion/motivation for doing so would have been to “enabling a physician to track the location/path of such catheters as they are inserted within and/or withdrawn from patients” (Huennekens, para. [0005]).
Dascal, in view of Arun, and in view of Huennekens, teaches wherein marking the starting location and the ending location includes using image pattern recognition software, allowing a user to manually mark the starting location and the ending location, or both (Dascal, para. [0112]; Huennekens, para. [0053]; see rejection above; it is known from Dascal, in view of Arun, to mark the starting location and the ending location of the imaging element on the extravascular imaging data; Huennekens teaches image pattern recognition software, allowing a user to manually mark locations; modifying Dascal, in view of Arun, with Huennekens, allows for a user to manually mark the starting location and the ending location, or both).
Therefore, it would have been obvious to combine Dascal and Arun, with Huennekens, to obtain the invention as specified in claim 7.
Regarding claim 9, Dascal, in view of Arun, teaches the method of claim 8, identifying the visualized anatomical landmark on the extravascular imaging data (Dascal, para. [0027]: para. [0094]; FIG. 7A-7F; see rejection of claim 8 above).
Dascal, in view of Arun, fails to teach
allowing a user to manually mark locations, using image pattern recognition software, or both.
Huennekens teaches
allowing a user to manually mark locations, using image pattern recognition software, or both (Huennekens, para. [0053]: “Establishing a position for the marker artifact within the field of the enhanced radiological image, based at least in part upon a radiopaque marker on the imaging catheter 20 is achievable in a variety of ways. Examples, described further herein below include: user-specified points (by clicking at a position near the marker to establish a point); image pattern recognition (automatic identification of a marker's unique signature within a field of view); and combinations of manual and automated calculations of a path.”).
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify the step of identifying the visualized anatomical landmark on the extravascular imaging data, as taught by Dascal, in view of Arun, to allow a user to manually mark locations, using image pattern recognition software, or both, as taught by Huennekens.
The suggestion/motivation for doing so would have been to “enabling a physician to track the location/path of such catheters as they are inserted within and/or withdrawn from patients” (Huennekens, para. [0005]).
Dascal, in view of Arun, and in view of Huennekens, teaches wherein identifying the visualized anatomical landmark on the extravascular imaging data includes allowing a user to manually mark the visualized anatomical landmark on the extravascular imaging data, using image pattern recognition software, or both (Dascal, para. [0112]; Huennekens, para. [0053]; see rejection above; it is known from Dascal, in view of Arun, to mark anatomical landmarks on the extravascular imaging data; Huennekens teaches a user manually mark locations and/or using image pattern recognition software; modifying Dascal, in view of Arun, with Huennekens, allows a user to manually mark the visualized anatomical landmark on the extravascular imaging data, using image pattern recognition software, or both).
Therefore, it would have been obvious to combine Dascal and Arun, with Huennekens, to obtain the invention as specified in claim 9.
Regarding claim 10, Dascal, in view of Arun, and in view of Huennekens, teaches the method of claim 9, wherein identifying the visualized anatomical landmark on the extravascular imaging data includes the image pattern recognition software marking the visualized anatomical landmark on the extravascular imaging data (Dascal, para. [0112]; Huennekens, para. [0053]; see rejection of claim 9 above; it is known from Dascal, in view of Arun, to mark anatomical landmarks on the extravascular imaging data; Huennekens teaches a user manually mark locations and/or using image pattern recognition software; modifying Dascal, in view of Arun, with Huennekens, leads to marking the visualized anatomical landmark on the extravascular imaging data, using image pattern recognition software).
Regarding claim 11, Dascal, in view of Arun, teaches the method of claim 1, marking the predicted location of the detected anatomical landmark on the extravascular (Dascal, para. [0017]; [0163]; see rejection of claim 1 above).
Dascal, in view of Arun, fails to teach
allowing a user to manually mark locations, using image pattern recognition software, or both.
Huennekens teaches
allowing a user to manually mark locations, using image pattern recognition software, or both (Huennekens, para. [0053]; para. [0082]: “Establishing a position for the marker artifact within the field of the enhanced radiological image, based at least in part upon a radiopaque marker on the imaging catheter 20 is achievable in a variety of ways. Examples, described further herein below include: user-specified points (by clicking at a position near the marker to establish a point); image pattern recognition (automatic identification of a marker's unique signature within a field of view); and combinations of manual and automated calculations of a path.”; “During step 1205 a user positions the cursor/slider mark on the calculated path. Such repositioning can occur in any of a number of ways. By way of example, the user drags and drops the cursor/slider using a mouse. Alternatively, a keyboard input can advance/backup the cursor/slider through a series of previously designated/bookmarked points along the calculated path displayed within the enhanced angiogram image provided during step 1200. Yet other keys can be used to advance the cursor/slider on a record-by-record basis through a set of stored records associated with the progression of the probe 22 along the calculated path. Still other modes of selecting a position of interest on the calculated path and its associated probe 22 (e.g., IVUS) image will be contemplated by those skilled in the art in view of the description provided herein.”).
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify the step of marking the predicted location of the detected anatomical landmark on the extravascular imaging data, as taught by Dascal, in view of Arun, to allow a user to manually mark locations, using image pattern recognition software, or both, as taught by Huennekens.
The suggestion/motivation for doing so would have been to “enabling a physician to track the location/path of such catheters as they are inserted within and/or withdrawn from patients” (Huennekens, para. [0005]).
Dascal, in view of Arun, and in view of Huennekens, teaches wherein marking the predicted location of the detected anatomical landmark on the extravascular imaging data includes using image pattern recognition software, allowing a user to manually mark the predicted location of the detected anatomical landmark on the extravascular imaging data, or both (Dascal, para. [0112]; Huennekens, para. [0053]; para. [0082] see rejection above; it is known from Dascal, in view of Arun, to mark the predicted location of the detected anatomical landmark on the extravascular imaging data; Huennekens teaches a user manually mark locations and/or using image pattern recognition software and manually repositioning cursors and automatically calculating the approximate position; modifying Dascal, in view of Arun, with Huennekens, allows a user to manually mark the predicted location of the detected anatomical landmark on the extravascular imaging data, or both).
Therefore, it would have been obvious to combine Dascal and Arun, with Huennekens, to obtain the invention as specified in claim 11.
Regarding claim 13, Dascal, in view of Arun, teaches the method of claim 1, aligning the predicted location of the detected anatomical landmark with the visualized anatomical landmark (Dascal, para. [0045]-[0046]; para. [0112]; FIG. 3A; para. [0027]; para. [0012]; para. [0015]-[0017]; Arun, para. [0049]-[0050]; FIG. 3; see rejection of claim 1 above).
Dascal, in view of Arun, fails to teach
allowing a user to manually align locations, using image pattern recognition software, or both.
Huennekens teaches
allowing a user to manually align locations, using image pattern recognition software, or both (Huennekens, para. [0053]; para. [0082]: “Establishing a position for the marker artifact within the field of the enhanced radiological image, based at least in part upon a radiopaque marker on the imaging catheter 20 is achievable in a variety of ways. Examples, described further herein below include: user-specified points (by clicking at a position near the marker to establish a point); image pattern recognition (automatic identification of a marker's unique signature within a field of view); and combinations of manual and automated calculations of a path.”; “During step 1205 a user positions the cursor/slider mark on the calculated path. Such repositioning can occur in any of a number of ways. By way of example, the user drags and drops the cursor/slider using a mouse. Alternatively, a keyboard input can advance/backup the cursor/slider through a series of previously designated/bookmarked points along the calculated path displayed within the enhanced angiogram image provided during step 1200. Yet other keys can be used to advance the cursor/slider on a record-by-record basis through a set of stored records associated with the progression of the probe 22 along the calculated path. Still other modes of selecting a position of interest on the calculated path and its associated probe 22 (e.g., IVUS) image will be contemplated by those skilled in the art in view of the description provided herein.”).
It would have been obvious to a person having ordinary skill in the art before the time of the effective filing date of the claimed invention of the instant application to modify the step of aligning the predicted location of the detected anatomical landmark with the visualized anatomical landmark, as taught by Dascal, in view of Arun, to include allowing a user to manually align locations, using image pattern recognition software, or both, as taught by Huennekens.
The suggestion/motivation for doing so would have been to “enabling a physician to track the location/path of such catheters as they are inserted within and/or withdrawn from patients” (Huennekens, para. [0005]).
Dascal, in view of Arun, and in view of Huennekens, teaches wherein aligning the predicted location of the detected anatomical landmark with the visualized anatomical landmark includes allowing a user to manually align the predicted location of the detected anatomical landmark with the visualized anatomical landmark (Dascal, para. [0045]-[0046]; para. [0112]; FIG. 3A; para. [0027]; para. [0012]; para. [0015]-[0017]; Arun, para. [0049]-[0050]; FIG. 3; Huennekens, para. [0053]; para. [0082]; Dascal, in view of Arun, teaches aligning the predicted location of the detected anatomical landmark with the visualized anatomical landmark automatically; Huennekens teaches manually aligning locations; Dascal, in view of Arun, and in view of Huennekens teaches using manual repositioning of cursors for aligning the visualized and detected anatomical landmarks).
Therefore, it would have been obvious to combine Dascal and Arun, with Huennekens, to obtain the invention as specified in claim 13.
Allowable Subject Matter
Claims 17 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/MICHAEL ADAM SHARIFF/
Examiner, Art Unit 2672
/SUMATI LEFKOWITZ/Supervisory Patent Examiner, Art Unit 2672
Prosecution Insights