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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/03/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 14, & 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mahesh et al (US20070129626A1; hereinafter referred to as Mahesh) in view of Seo Joon et al (KR20140128131A; hereinafter referred to as Seo Joon).
Regarding Claim 1, Mahesh discloses a method for provision of a result data set (“a method for facilitating surgery including: tracking a position of at least a portion of a surgical implement in a volume of interest; recognizing a surgical plan corresponding to at least a portion of the volume of interest; and providing feedback based on a correspondence between the position of the at least a portion of the surgical implement and the surgical plan.” [Abstract]), the method comprising:
providing a first planning image that maps a motion of an object under examination prior to positioning of a medical object in the object under examination, and wherein the first planning image contains planning information about a planned positioning of the medical object in the object under examination (“At step 804, a surgical plan corresponding to at least a portion of the volume of interest (e.g. 702) may be recognized. For example, a surgical plan may be recognized by a processing subsystem (e.g. 710) capable of loading and/or uploading at least a portion of the surgical plan. The surgical plan may have been generated through methods, such as method 200 and/or 600, for example. The surgical plan may include trajectory information for a surgical implement and/or other actions, such as planned ablation positions (e.g. thermal or cryoablations). The surgical plan may also include information about a pathology, such as a segmentation of a tumor, for example. The surgical plan may include radiological image data, such as image data generated prior to surgery. The image data may be generated with a contrast agent in a volume of interest, for example. The plan may be two, three, and/or four dimensional, for example. The plan may be coordinated and/or mapped with other data types for use in conjunction with method 800, for example. The plan may be coordinated with position data tracked at step 802, for example.” [0068], “A surgical plan, including trajectories 906 and positions 908 may be mapped onto the real-time image, for example. The surgical plan may be mapped onto the image through Boolean union or the like.” [0072]);
acquiring a first monitoring image, after the positioning of the medical object in the object under examination (“a real-time ultrasonic four dimensional image is displayed to the surgeon. The ultrasonic image has been fused with a three dimensional image of the same volume generated prior to surgery with a CT scan. The prior image was generated with a contrast agent. The fusion of the two images produces enhanced anatomical visibility in the display. Further, the surgical plan, having the trajectories and ablation tool positions is displayed. In addition, the current position of the ablation tool is also displayed. In this particular example, all data is displayed together in a single three-dimensional image in real time. However, the application also allows various two-dimensional views to be displayed simultaneously, including axial, coronal, sagittal, and/or oblique views.” [0075]);
and providing the result data set based on: (a) the first planning image and positioning information determined by identification of a mapping of the medical object in the first monitoring image, or (b) the planning information and the first monitoring image (“The processing subsystem 710 may be able to compare the position of the implement 704 with a surgical plan and determine if the implement 704 is in the proper position, for example. Based on the correspondence between the tracked position of the implement 704 and the planned position and/or trajectory of a substantially similar implement 704 during surgical planning, the processing subsystem 710 may be able to control a feedback subsystem 712, for example. Other comparisons may also be possible including the following: surgical plan data versus radiological imaging subsystem 714 data, and tracking subsystem 706 data versus radiological imaging subsystem 714 data, for example. Any comparison that indicates the position of the implement 704 with respect to the expected position of the implement may result in the processing subsystem 710 controlling the feedback subsystem 712, for example.” [0064], “a combination display including a surgical plan and a three-dimensional real-time image of a volume of interest, in accordance with an embodiment of the present invention. A volume of interest 902 may include real-time ultrasonic data fused with a prior three-dimensional CT scan (taken with contrast in the patient), for example. A prior three-dimensional CT scan may be a three-dimensional reconstruction scan. In the volume of interest 902 a segmented structure 904, such as a segmented tumor, may be included, for example. Segmentation may have been performed during prior imaging and/or processing, for example, in accordance with method 200 and/or 600, for example. A surgical plan, including trajectories 906 and positions 908 may be mapped onto the real-time image” [0072], “At step 806, the processing subsystem compares the position of the implement with the plan. If the position and trajectory of the ablation tool corresponds to the surgical plan, then the tool functions properly, and no signal is provided. The absence of a signal indicates to the clinician that the tool is positioned and is functioning as planned. If, however, the radiologist deviates from the surgical plan, a vibration is provided to the radiologist to indicate that the plan is not being followed.” [0074].
Mahesh does not specifically disclose that the planning image maps a first physiological phase of motion, wherein the first physiological phase of motion comprises a temporal section of the motion of a plurality of periodically recurring temporal sections of motion, and the monitoring image maps the same first physiological phase comprising the same temporal section of the motion of the object under examination and the medical object arranged in the object under examination.
However, in a similar field of endeavor, Seo Joon teaches a method of comparing preoperative respiratory level with intraoperative respiratory level [0001].
Seo Joon also teaches that the planning image maps a first physiological phase of motion, wherein the first physiological phase of motion comprises a temporal section of the motion of a plurality of periodically recurring temporal sections of motion (“Figure 5 is drawing showing an example of the method for making the before surgery image template. The before surgery image template (11) is to medical images (11a,11b,11c,11d,11e) of 5. 5 medical images (11a,11b,11c,11d,11e) includes at least one, actually, the medical image, and at least one prediction medical image. For example, the medical image (11a) is produced from actually photographed 3-dimensional image (10) according to the reference (30) and rest medical images (11b,11c,11d,11e) the movement of the affected part (20) according to the respiration are predicted based on the medical image (11a) based on the experience of the doctor and it can produce. In the operating room through such before surgery image template (11), when it uses with the operating room image template (12) , the respiration level of the patient is more easily grasped. Moreover, for example, 2 medical images (11a,11e) the actually can be produced from the medical image. Then, 2 3-dimensional images (30) is necessary and it takes a picture in the state that once completely breathes with CT and the CT scan 3-dimensional image (30) of 2 can be obtained from the state that it once completely breathes out as box. Medical images (11a,11e) of 2 can be obtained from each of them according to the reference (30). Actually photographed medical images (11a,11e) of 2 are used. In that way in other words, in other words, actually photographed medical images (11a,11e) more than at least 2 are used. In that way the accuracy of prediction medical images (11b,11c,11d) is increased. Especially, in case medical images (11a,11e) about the high limit of the respiration level and limit inferior are obtained the prediction accuracy is enhanced. As necessary, the medical image (11c) etc. can produce through the actual photographing. For example, actual and prediction medical image of 20 amendment plan are included in the before surgery image template (11). In that way the movement of the affected part (20) according to the respiration level can be very accurately expressed and in case it is the image showing the affected part in which the operating room image template (12) moves the comparison between reciprocity is facilitated more. For example, after all images within the before surgery image template (11) are shown in terms of the background image it is possible to show the operating room image template (12).” [0021]),
and the monitoring image maps the same first physiological phase comprising the same temporal section of the motion of the object under examination and the medical object arranged in the object under examination (“Figure 6 is drawing showing an example of the display screen according to the disclosure. It can be understood as one GUI (Graphic User Interface). It is possible to display the before surgery image template (11) and operating room image template (12) in the simultaneously. However it has the case of being difficult or being unnecessary according to the performance of the computer in and, the viewpoint of the time consumption. As shown in Figure 6, in the state showing only the operating room image template (12), the similarity of the before surgery image template (11) calculates as *** process and as the similarity increases in the display it makes the colour of the screen dense or it expresses in the method of the etc. indicated by the red colour through the colour or it informs by the method of the etc. which gives the flicker and which expresses or done by the visual, and the auditive method. Moreover, the part which can be subjected of the comparison is chosen from the before surgery image template (11) and this is indicated by the comparative line (L1,L2,L3,L4,L5). In that way the similarity of both sides is by intuition understood but it can help. As the similarity is enhanced the change is possible to give the change to the colour of the comparative line (L1,L2,L3,L4,L5) and enhance the intuition ability.” [0022]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh as outlined above with the planning image maps a first physiological phase of motion, wherein the first physiological phase of motion comprises a temporal section of the motion of a plurality of periodically recurring temporal sections of motion, and the monitoring image maps the same first physiological phase comprising the same temporal section of the motion of the object under examination and the medical object arranged in the object under examination as taught by Seo Joon, because the intraoperative respiratory phase must be matched with the pre operative image so that the planned path remains valid [0008].
Regarding Claim 19, Mahesh discloses a medical imaging device (“a method for facilitating surgery including: tracking a position of at least a portion of a surgical implement in a volume of interest; recognizing a surgical plan corresponding to at least a portion of the volume of interest; and providing feedback based on a correspondence between the position of the at least a portion of the surgical implement and the surgical plan.” [Abstract]) comprising:
an X-ray device (“Some types of image processing subsystems 102 include computed tomography (CT), magnetic resonance imaging (MRI), x-ray, positron emission tomography (PET), tomosynthesis, and/or the like, for example. An imaging modality, such as CT, may be enhanced through a contrast agent administered to a patient, for example. An image generation subsystem 102 may generate one or more data sets corresponding to an image which may be communicated over a communications link 104 to a storage 114 and/or an image processing subsystem 116.” [0020]) configured to:
acquire a first planning image that maps a first physiological phase of a motion of an object under examination prior to positioning of a medical object in the object under examination, and wherein the first planning image contains planning information about a planned positioning of the medical object in the object under examination (“At step 804, a surgical plan corresponding to at least a portion of the volume of interest (e.g. 702) may be recognized. For example, a surgical plan may be recognized by a processing subsystem (e.g. 710) capable of loading and/or uploading at least a portion of the surgical plan. The surgical plan may have been generated through methods, such as method 200 and/or 600, for example. The surgical plan may include trajectory information for a surgical implement and/or other actions, such as planned ablation positions (e.g. thermal or cryoablations). The surgical plan may also include information about a pathology, such as a segmentation of a tumor, for example. The surgical plan may include radiological image data, such as image data generated prior to surgery. The image data may be generated with a contrast agent in a volume of interest, for example. The plan may be two, three, and/or four dimensional, for example. The plan may be coordinated and/or mapped with other data types for use in conjunction with method 800, for example. The plan may be coordinated with position data tracked at step 802, for example.” [0068], “A surgical plan, including trajectories 906 and positions 908 may be mapped onto the real-time image, for example. The surgical plan may be mapped onto the image through Boolean union or the like.” [0072]);
and acquire a first monitoring image, after the positioning of the medical object in the object under examination (“a real-time ultrasonic four dimensional image is displayed to the surgeon. The ultrasonic image has been fused with a three dimensional image of the same volume generated prior to surgery with a CT scan. The prior image was generated with a contrast agent. The fusion of the two images produces enhanced anatomical visibility in the display. Further, the surgical plan, having the trajectories and ablation tool positions is displayed. In addition, the current position of the ablation tool is also displayed. In this particular example, all data is displayed together in a single three-dimensional image in real time. However, the application also allows various two-dimensional views to be displayed simultaneously, including axial, coronal, sagittal, and/or oblique views.” [0075]);
wherein the medical imaging device is configured to provide a result data set based on: (a) the first planning image and positioning information determined by identification of a mapping of the medical object in the first monitoring image, or (b) the planning information and the first monitoring image (“The processing subsystem 710 may be able to compare the position of the implement 704 with a surgical plan and determine if the implement 704 is in the proper position, for example. Based on the correspondence between the tracked position of the implement 704 and the planned position and/or trajectory of a substantially similar implement 704 during surgical planning, the processing subsystem 710 may be able to control a feedback subsystem 712, for example. Other comparisons may also be possible including the following: surgical plan data versus radiological imaging subsystem 714 data, and tracking subsystem 706 data versus radiological imaging subsystem 714 data, for example. Any comparison that indicates the position of the implement 704 with respect to the expected position of the implement may result in the processing subsystem 710 controlling the feedback subsystem 712, for example.” [0064], “a combination display including a surgical plan and a three-dimensional real-time image of a volume of interest, in accordance with an embodiment of the present invention. A volume of interest 902 may include real-time ultrasonic data fused with a prior three-dimensional CT scan (taken with contrast in the patient), for example. A prior three-dimensional CT scan may be a three-dimensional reconstruction scan. In the volume of interest 902 a segmented structure 904, such as a segmented tumor, may be included, for example. Segmentation may have been performed during prior imaging and/or processing, for example, in accordance with method 200 and/or 600, for example. A surgical plan, including trajectories 906 and positions 908 may be mapped onto the real-time image” [0072], “At step 806, the processing subsystem compares the position of the implement with the plan. If the position and trajectory of the ablation tool corresponds to the surgical plan, then the tool functions properly, and no signal is provided. The absence of a signal indicates to the clinician that the tool is positioned and is functioning as planned. If, however, the radiologist deviates from the surgical plan, a vibration is provided to the radiologist to indicate that the plan is not being followed.” [0074].
Mahesh does not specifically disclose that the planning image maps a first physiological phase of motion, wherein the first physiological phase of motion comprises a temporal section of the motion of a plurality of periodically recurring temporal sections of motion, and the monitoring image maps the same first physiological phase comprising the same temporal section of the motion of the object under examination and the medical object arranged in the object under examination.
However, in a similar field of endeavor, Seo Joon teaches a method of comparing preoperative respiratory level with intraoperative respiratory level [0001].
Seo Joon also teaches that the planning image maps a first physiological phase of motion, wherein the first physiological phase of motion comprises a temporal section of the motion of a plurality of periodically recurring temporal sections of motion (“Figure 5 is drawing showing an example of the method for making the before surgery image template. The before surgery image template (11) is to medical images (11a,11b,11c,11d,11e) of 5. 5 medical images (11a,11b,11c,11d,11e) includes at least one, actually, the medical image, and at least one prediction medical image. For example, the medical image (11a) is produced from actually photographed 3-dimensional image (10) according to the reference (30) and rest medical images (11b,11c,11d,11e) the movement of the affected part (20) according to the respiration are predicted based on the medical image (11a) based on the experience of the doctor and it can produce. In the operating room through such before surgery image template (11), when it uses with the operating room image template (12) , the respiration level of the patient is more easily grasped. Moreover, for example, 2 medical images (11a,11e) the actually can be produced from the medical image. Then, 2 3-dimensional images (30) is necessary and it takes a picture in the state that once completely breathes with CT and the CT scan 3-dimensional image (30) of 2 can be obtained from the state that it once completely breathes out as box. Medical images (11a,11e) of 2 can be obtained from each of them according to the reference (30). Actually photographed medical images (11a,11e) of 2 are used. In that way in other words, in other words, actually photographed medical images (11a,11e) more than at least 2 are used. In that way the accuracy of prediction medical images (11b,11c,11d) is increased. Especially, in case medical images (11a,11e) about the high limit of the respiration level and limit inferior are obtained the prediction accuracy is enhanced. As necessary, the medical image (11c) etc. can produce through the actual photographing. For example, actual and prediction medical image of 20 amendment plan are included in the before surgery image template (11). In that way the movement of the affected part (20) according to the respiration level can be very accurately expressed and in case it is the image showing the affected part in which the operating room image template (12) moves the comparison between reciprocity is facilitated more. For example, after all images within the before surgery image template (11) are shown in terms of the background image it is possible to show the operating room image template (12).” [0021]),
and the monitoring image maps the same first physiological phase comprising the same temporal section of the motion of the object under examination and the medical object arranged in the object under examination (“Figure 6 is drawing showing an example of the display screen according to the disclosure. It can be understood as one GUI (Graphic User Interface). It is possible to display the before surgery image template (11) and operating room image template (12) in the simultaneously. However it has the case of being difficult or being unnecessary according to the performance of the computer in and, the viewpoint of the time consumption. As shown in Figure 6, in the state showing only the operating room image template (12), the similarity of the before surgery image template (11) calculates as *** process and as the similarity increases in the display it makes the colour of the screen dense or it expresses in the method of the etc. indicated by the red colour through the colour or it informs by the method of the etc. which gives the flicker and which expresses or done by the visual, and the auditive method. Moreover, the part which can be subjected of the comparison is chosen from the before surgery image template (11) and this is indicated by the comparative line (L1,L2,L3,L4,L5). In that way the similarity of both sides is by intuition understood but it can help. As the similarity is enhanced the change is possible to give the change to the colour of the comparative line (L1,L2,L3,L4,L5) and enhance the intuition ability.” [0022]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh as outlined above with the planning image maps a first physiological phase of motion, wherein the first physiological phase of motion comprises a temporal section of the motion of a plurality of periodically recurring temporal sections of motion, and the monitoring image maps the same first physiological phase comprising the same temporal section of the motion of the object under examination and the medical object arranged in the object under examination as taught by Seo Joon, because the intraoperative respiratory phase must be matched with the pre operative image so that the planned path remains valid [0008].
Regarding Claim 20, Mahesh discloses A non-transitory computer program product with a computer program, which is configured to be loaded into a memory of a medical imaging device, wherein the computer program, when executed, is configured to cause the medical imaging device to (“a method for facilitating surgery including: tracking a position of at least a portion of a surgical implement in a volume of interest; recognizing a surgical plan corresponding to at least a portion of the volume of interest; and providing feedback based on a correspondence between the position of the at least a portion of the surgical implement and the surgical plan.” [Abstract], “A memory 106 may be a computer-readable memory, for example, such as a hard disk, floppy disk, CD, CD-ROM, DVD, compact storage, flash memory, random access memory, read-only memory, electrically erasable and programmable read-only memory and/or other memory.” [0023]):
provide a first planning image that maps a first physiological phase of a motion of an object under examination prior to positioning of a medical object in the object under examination, and wherein the first planning image contains planning information about a planned positioning of the medical object in the object under examination (“At step 804, a surgical plan corresponding to at least a portion of the volume of interest (e.g. 702) may be recognized. For example, a surgical plan may be recognized by a processing subsystem (e.g. 710) capable of loading and/or uploading at least a portion of the surgical plan. The surgical plan may have been generated through methods, such as method 200 and/or 600, for example. The surgical plan may include trajectory information for a surgical implement and/or other actions, such as planned ablation positions (e.g. thermal or cryoablations). The surgical plan may also include information about a pathology, such as a segmentation of a tumor, for example. The surgical plan may include radiological image data, such as image data generated prior to surgery. The image data may be generated with a contrast agent in a volume of interest, for example. The plan may be two, three, and/or four dimensional, for example. The plan may be coordinated and/or mapped with other data types for use in conjunction with method 800, for example. The plan may be coordinated with position data tracked at step 802, for example.” [0068], “A surgical plan, including trajectories 906 and positions 908 may be mapped onto the real-time image, for example. The surgical plan may be mapped onto the image through Boolean union or the like.” [0072]);
acquire a first monitoring image, after the positioning of the medical object in the object under examination (“a real-time ultrasonic four dimensional image is displayed to the surgeon. The ultrasonic image has been fused with a three dimensional image of the same volume generated prior to surgery with a CT scan. The prior image was generated with a contrast agent. The fusion of the two images produces enhanced anatomical visibility in the display. Further, the surgical plan, having the trajectories and ablation tool positions is displayed. In addition, the current position of the ablation tool is also displayed. In this particular example, all data is displayed together in a single three-dimensional image in real time. However, the application also allows various two-dimensional views to be displayed simultaneously, including axial, coronal, sagittal, and/or oblique views.” [0075]);
and provide a result data set based on: (a) the first planning image and positioning information determined by identification of a mapping of the medical object in the first monitoring image, or (b) the planning information and the first monitoring image (“The processing subsystem 710 may be able to compare the position of the implement 704 with a surgical plan and determine if the implement 704 is in the proper position, for example. Based on the correspondence between the tracked position of the implement 704 and the planned position and/or trajectory of a substantially similar implement 704 during surgical planning, the processing subsystem 710 may be able to control a feedback subsystem 712, for example. Other comparisons may also be possible including the following: surgical plan data versus radiological imaging subsystem 714 data, and tracking subsystem 706 data versus radiological imaging subsystem 714 data, for example. Any comparison that indicates the position of the implement 704 with respect to the expected position of the implement may result in the processing subsystem 710 controlling the feedback subsystem 712, for example.” [0064], “a combination display including a surgical plan and a three-dimensional real-time image of a volume of interest, in accordance with an embodiment of the present invention. A volume of interest 902 may include real-time ultrasonic data fused with a prior three-dimensional CT scan (taken with contrast in the patient), for example. A prior three-dimensional CT scan may be a three-dimensional reconstruction scan. In the volume of interest 902 a segmented structure 904, such as a segmented tumor, may be included, for example. Segmentation may have been performed during prior imaging and/or processing, for example, in accordance with method 200 and/or 600, for example. A surgical plan, including trajectories 906 and positions 908 may be mapped onto the real-time image” [0072], “At step 806, the processing subsystem compares the position of the implement with the plan. If the position and trajectory of the ablation tool corresponds to the surgical plan, then the tool functions properly, and no signal is provided. The absence of a signal indicates to the clinician that the tool is positioned and is functioning as planned. If, however, the radiologist deviates from the surgical plan, a vibration is provided to the radiologist to indicate that the plan is not being followed.” [0074].
Mahesh does not specifically disclose that the planning image maps a first physiological phase of motion, wherein the first physiological phase of motion comprises a temporal section of the motion of a plurality of periodically recurring temporal sections of motion, and the monitoring image maps the same first physiological phase comprising the same temporal section of the motion of the object under examination and the medical object arranged in the object under examination.
However, in a similar field of endeavor, Seo Joon teaches a method of comparing preoperative respiratory level with intraoperative respiratory level [0001].
Seo Joon also teaches that the planning image maps a first physiological phase of motion, wherein the first physiological phase of motion comprises a temporal section of the motion of a plurality of periodically recurring temporal sections of motion (“Figure 5 is drawing showing an example of the method for making the before surgery image template. The before surgery image template (11) is to medical images (11a,11b,11c,11d,11e) of 5. 5 medical images (11a,11b,11c,11d,11e) includes at least one, actually, the medical image, and at least one prediction medical image. For example, the medical image (11a) is produced from actually photographed 3-dimensional image (10) according to the reference (30) and rest medical images (11b,11c,11d,11e) the movement of the affected part (20) according to the respiration are predicted based on the medical image (11a) based on the experience of the doctor and it can produce. In the operating room through such before surgery image template (11), when it uses with the operating room image template (12) , the respiration level of the patient is more easily grasped. Moreover, for example, 2 medical images (11a,11e) the actually can be produced from the medical image. Then, 2 3-dimensional images (30) is necessary and it takes a picture in the state that once completely breathes with CT and the CT scan 3-dimensional image (30) of 2 can be obtained from the state that it once completely breathes out as box. Medical images (11a,11e) of 2 can be obtained from each of them according to the reference (30). Actually photographed medical images (11a,11e) of 2 are used. In that way in other words, in other words, actually photographed medical images (11a,11e) more than at least 2 are used. In that way the accuracy of prediction medical images (11b,11c,11d) is increased. Especially, in case medical images (11a,11e) about the high limit of the respiration level and limit inferior are obtained the prediction accuracy is enhanced. As necessary, the medical image (11c) etc. can produce through the actual photographing. For example, actual and prediction medical image of 20 amendment plan are included in the before surgery image template (11). In that way the movement of the affected part (20) according to the respiration level can be very accurately expressed and in case it is the image showing the affected part in which the operating room image template (12) moves the comparison between reciprocity is facilitated more. For example, after all images within the before surgery image template (11) are shown in terms of the background image it is possible to show the operating room image template (12).” [0021]),
and the monitoring image maps the same first physiological phase comprising the same temporal section of the motion of the object under examination and the medical object arranged in the object under examination (“Figure 6 is drawing showing an example of the display screen according to the disclosure. It can be understood as one GUI (Graphic User Interface). It is possible to display the before surgery image template (11) and operating room image template (12) in the simultaneously. However it has the case of being difficult or being unnecessary according to the performance of the computer in and, the viewpoint of the time consumption. As shown in Figure 6, in the state showing only the operating room image template (12), the similarity of the before surgery image template (11) calculates as *** process and as the similarity increases in the display it makes the colour of the screen dense or it expresses in the method of the etc. indicated by the red colour through the colour or it informs by the method of the etc. which gives the flicker and which expresses or done by the visual, and the auditive method. Moreover, the part which can be subjected of the comparison is chosen from the before surgery image template (11) and this is indicated by the comparative line (L1,L2,L3,L4,L5). In that way the similarity of both sides is by intuition understood but it can help. As the similarity is enhanced the change is possible to give the change to the colour of the comparative line (L1,L2,L3,L4,L5) and enhance the intuition ability.” [0022]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh as outlined above with the planning image maps a first physiological phase of motion, wherein the first physiological phase of motion comprises a temporal section of the motion of a plurality of periodically recurring temporal sections of motion, and the monitoring image maps the same first physiological phase comprising the same temporal section of the motion of the object under examination and the medical object arranged in the object under examination as taught by Seo Joon, because the intraoperative respiratory phase must be matched with the pre operative image so that the planned path remains valid [0008].
Regarding Claim 14, Mahesh discloses that the first planning image and the first monitoring image are acquired by a same medical imaging device or by different medical imaging devices (“An image generation subsystem 102 may be any radiological system capable of generating two-dimensional, three-dimensional, and/or four-dimensional data corresponding to a volume of interest of a patient. A volume of interest of a patient may include tissue, organs, fluids, pathologies (e.g. tumors, abscesses, cysts, etc.), and/or the like. Some types of image processing subsystems 102 include computed tomography (CT), magnetic resonance imaging (MRI), x-ray, positron emission tomography (PET), tomosynthesis, and/or the like, for example. An imaging modality, such as CT, may be enhanced through a contrast agent administered to a patient, for example. An image generation subsystem 102 may generate one or more data sets corresponding to an image which may be communicated over a communications link 104 to a storage 114 and/or an image processing subsystem 116.” [0020]).
Claims 2-9, 11-13 & 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mahesh in view of Seo Joon as applied to Claim 1 above, and further in view of Walsum et al (US20200222018A1; hereinafter referred to as Walsum)
Regarding Claim 2, Mahesh in view of Seo Joon discloses all limitation noted above except that at least one further monitoring image is acquired, wherein the at least one further monitoring image maps at least one further physiological phase of the motion of the object under examination and the medical object arranged in the object under examination, wherein, in each case, positioning information about the first monitoring image and the at least one further monitoring image is determined by identification in each case of a mapping of the medical object in the first monitoring image and the at least one further monitoring image, wherein a transformation rule between the positioning information of the first monitoring image and the positioning information of the at least one further monitoring image is determined, and wherein the result data set is further provided based on the transformation rule.
However, in a similar field of endeavor, Waslum teaches methods for dynamically visualizing information in image data of an object of interest of a patient [Abstract].
Waslum also teaches that at least one further monitoring image is acquired, wherein the at least one further monitoring image maps at least one further physiological phase of the motion of the object under examination and the medical object arranged in the object under examination (“ ii) determining a plurality of reference locations of a device in the first image data, wherein the plurality of reference locations correspond to the plurality of roadmaps of the object of interest of i)” [0011], “Within step 103, the X-ray angiographic image sequence is processed to create roadmaps of coronary arteries for multiple phases of the cardiac cycle after the frame in which the contrast liquids enters the coronary artery. Typically, the roadmaps are created for an amount of frames covering at least one cardiac cycle.” [0140]),
wherein, in each case, positioning information about the first monitoring image and the at least one further monitoring image is determined by identification in each case of a mapping of the medical object in the first monitoring image and the at least one further monitoring image, wherein a transformation rule between the positioning information of the first monitoring image and the positioning information of the at least one further monitoring image is determined, and wherein the result data set is further provided based on the transformation rule (“As described herein, a reference point can be used to compensate for motion between the roadmaps obtained from the X-ray angiographic image sequence (offline phase) with the X-ray fluoroscopic image stream (online phase). The reference point, which can be extracted from the device location, can be any object in which its motion can be correlated to the breathing motion and patient motion and the device can be for example the catheter tip, pacemaker or an anatomical landmarks. Within a preferred embodiment the device is a guiding catheter and the device location is the guiding catheter tip. Within step 107, the location of the device (e.g. catheter tip) in current X-ray fluoroscopic frame, as a result of step 106, and the device location (e.g. catheter tip) from the selected roadmap frame as a result of step 105 is used to obtain a transformation function to align the selected roadmap with the current X-ray fluoroscopic image frame. In embodiments, this transformation function might be a rigid transformation based on the displacement obtained from the catheter tip between the current frame and the catheter tip within the selected roadmap frame. Alternatively, the transformation function can be a non-rigid transformation.” [0184]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh in view of Seo Joon as outlined above with at least one further monitoring image is acquired, wherein the at least one further monitoring image maps at least one further physiological phase of the motion of the object under examination and the medical object arranged in the object under examination, wherein, in each case, positioning information about the first monitoring image and the at least one further monitoring image is determined by identification in each case of a mapping of the medical object in the first monitoring image and the at least one further monitoring image, wherein a transformation rule between the positioning information of the first monitoring image and the positioning information of the at least one further monitoring image is determined, and wherein the result data set is further provided based on the transformation rule as taught by Waslum, because it can align the selected roadmap with the current image frame [0184].
Regarding Claim 3, Mahesh in view of Seo Joon discloses all limitation noted above except that the result data set is provided based on the first planning image and adjusted positioning information, and wherein the adjusted positioning information is provided by applying the transformation rule to the positioning information.
However, in a similar field of endeavor, Waslum teaches that the result data set is provided based on the first planning image and adjusted positioning information, and wherein the adjusted positioning information is provided by applying the transformation rule to the positioning information (“Within a preferred embodiment the device is a guiding catheter and the device location is the guiding catheter tip. Within step 107, the location of the device (e.g. catheter tip) in current X-ray fluoroscopic frame, as a result of step 106, and the device location (e.g. catheter tip) from the selected roadmap frame as a result of step 105 is used to obtain a transformation function to align the selected roadmap with the current X-ray fluoroscopic image frame. In embodiments, this transformation function might be a rigid transformation based on the displacement obtained from the catheter tip between the current frame and the catheter tip within the selected roadmap frame.” [0184], “The dynamic roadmap that results from the cardiac matching and transformation of the roadmap is rendered and integrated as an overlay on the corresponding X-ray fluoroscopic or angiographic image data frame of the live angiographic image data image data stream of the patient.” [0187], “FIG. 10b shows another example, in which the picture on the left shows a single frame within an X-ray fluoroscopic image sequence and the picture on the right the same fluoroscopic X-ray image with dynamic roadmap superimposed in which dynamic motion such as breathing motion, patient motion and cardiac motion are corrected.” [0189]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh in view of Seo Joon as outlined above with the result data set is provided based on the first planning image and adjusted positioning information, and wherein the adjusted positioning information is provided by applying the transformation rule to the positioning information as taught by Waslum, because it can provide support for the clinician in improved patient treatment [0190].
Regarding Claim 4, Mahesh in view of Seo Joon discloses all limitations noted above except that the result data set is provided based on the planning information and adjusted monitoring images, and wherein the adjusted monitoring images are provided by applying the transformation rule to the first monitoring image and the at least one further monitoring image.
However, in a similar field of endeavor, Waslum teaches that the result data set is provided based on the planning information and adjusted monitoring images, and wherein the adjusted monitoring images are provided by applying the transformation rule to the first monitoring image and the at least one further monitoring image (“Within a preferred embodiment the device is a guiding catheter and the device location is the guiding catheter tip. Within step 107, the location of the device (e.g. catheter tip) in current X-ray fluoroscopic frame, as a result of step 106, and the device location (e.g. catheter tip) from the selected roadmap frame as a result of step 105 is used to obtain a transformation function to align the selected roadmap with the current X-ray fluoroscopic image frame. In embodiments, this transformation function might be a rigid transformation based on the displacement obtained from the catheter tip between the current frame and the catheter tip within the selected roadmap frame.” [0184], “The dynamic roadmap that results from the cardiac matching and transformation of the roadmap is rendered and integrated as an overlay on the corresponding X-ray fluoroscopic or angiographic image data frame of the live angiographic image data image data stream of the patient.” [0187], “FIG. 10b shows another example, in which the picture on the left shows a single frame within an X-ray fluoroscopic image sequence and the picture on the right the same fluoroscopic X-ray image with dynamic roadmap superimposed in which dynamic motion such as breathing motion, patient motion and cardiac motion are corrected.” [0189]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh in view of Seo Joon as outlined above with the result data set is provided based on the planning information and adjusted monitoring images, and wherein the adjusted monitoring images are provided by applying the transformation rule to the first monitoring image and the at least one further monitoring image as taught by Waslum, because it can provide support for the clinician in improved patient treatment [0190].
Regarding Claim 5, Mahesh in view of Seo Joon discloses all limitations noted above except that the providing of the result data set comprises a summing of the adjusted monitoring images.
However, in a similar field of endeavor, Waslum teaches that the providing of the result data set comprises a summing of the adjusted monitoring images (“the preprocessed frames are combined into a single image frame. This is performed by adding (3008 of FIG. 30) the preprocessed frames, and optionally a weighting factor is introduced which correlates to the likelihood of non-rigid deformation of each frame, for instance due to foreshortening. An example of a result of this process is presented by 3009 of FIG. 30. Within picture 3009, the calcified plaque is enhanced (3010).” [0291]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh in view of Seo Joon as outlined above with the providing of the result data set comprises a summing of the adjusted monitoring images as taught by Waslum, because it can provide support for the clinician in improved patient treatment [0190].
Regarding Claim 6, Mahesh in view of Seo Joon discloses all limitations noted above except that the determining of the transformation rule comprises a determination of a field of motion between mappings of the medical object in the first monitoring image and the at least one further monitoring image, and wherein the transformation rule is determined based on the field of motion.
However, in a similar field of endeavor, Waslum teaches that the determining of the transformation rule comprises a determination of a field of motion between mappings of the medical object in the first monitoring image and the at least one further monitoring image, and wherein the transformation rule is determined based on the field of motion (“A sample can be drawn from p(zk|xk-1 i) in the following way. First, a process noise sample vk-1 i is sampled from pv(vk-1), the PDF of vk-1; then xk i is generated from xk-1 i via the state transition model xk i=fk(xk-1 i,vk-1 i). Where, pv(vk-1) is set to be a Gaussian N(0, σv 2I). The choice of motion model for fk is important for an accurate representation of the true state transition prior p(xk|xk-1). A random motion cannot characterize well the motion of catheter tip in X-ray image frames. In this application, the motion is estimated from adjacent frames using an optical flow method, as this approach 1) takes into account of the observation zk, which results in a better guess of the catheter tip motion, and 2) enables estimation of a dense motion field where the motion of a sample xk i can be efficiently obtained. Therefore, fk is defined as Equation 11:” [0177], “where uk-1(⋅) is the motion from frame k−1 to frame k estimated with optical flow using the method as described as for instance by Farneback et al., “Two-frame motion estimation based on polynomial expansion”, Scandinavian conference on Image analysis 2003, Springer. pp. 363-370, uk-1(xk-1)) is the motion from state xk-1.” [0178], “The final decision on catheter tip location in frame k can then be computed as the expectation of xk,{circumflex over (x)}k=∫xk p(xk|z0:k)dxk, which is in this case, the weighted sum of all samples:” [0180], “The final catheter tip location as obtained from the tracking method is used in the next step 107 to determine the translation between the device location in the online fluoroscopic image and corresponding offline angiographic image of the selected roadmap.” [0182]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh in view of Seo Joon as outlined above with the determining of the transformation rule comprises a determination of a field of motion between mappings of the medical object in the first monitoring image and the at least one further monitoring image, and wherein the transformation rule is determined based on the field of motion as taught by Waslum, because it can provide support for the clinician in improved patient treatment [0190].
Regarding Claim 7, Mahesh in view of Seo Joon discloses all limitations noted above except that the first monitoring image is acquired by a physiological signal that maps physiological phases of the motion.
However, in a similar field of endeavor, Waslum teaches that the first monitoring image is acquired by a physiological signal that maps physiological phases of the motion (“, the method(s) can further involve processing an ECG signal synchronous with the second image data, for example acquired together with the second image data, to determine a phase of the cardiac cycle of the patient that corresponds to the second image data. The roadmap can be selected in iii) by matching the phase of the cardiac cycle of the patient for the second image data to the phase of the cardiac cycle of the patient for the selected roadmap.” [0021], “The X-ray angiography image sequence may comprise multiple frames covering one or more phases of the cardiac cycle. Throughout this patent application, a cardiac cycle is specific to a patent and is defined as the period in which covers one heartbeat of the patient. The cardiac cycle can be defined as the period of time between successive R-tops within the ECG signal of the patient. A phase refers to a moment (or period) of time within the cardiac cycle of the patient. Phase can be measured as an offset from R-top within the ECG signal of the patient as shown in FIG. 9 and its corresponding description.” [0105]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh in view of Seo Joon as outlined above with the determining of the transformation rule comprises a determination of a field of motion between mappings of the medical object in the first monitoring image and the at least one further monitoring image, and wherein the transformation rule is determined based on the field of motion as taught by Waslum, because it can provide support for the clinician in improved patient treatment [0190].
Regarding Claim 8, Mahesh in view of Seo Joon discloses all limitations noted above except that the motion of the object under examination comprises a cardiac motion, and wherein the first physiological phase is specified as a diastolic phase of the cardiac motion.
However, in a similar field of endeavor, Waslum teaches that the motion of the object under examination comprises a cardiac motion, and wherein the first physiological phase is specified as a diastolic phase of the cardiac motion (“the method(s) can further involve processing an ECG signal synchronous with the second image data, for example acquired together with the second image data, to determine a phase of the cardiac cycle of the patient that corresponds to the second image data. The roadmap can be selected in iii) by matching the phase of the cardiac cycle of the patient for the second image data to the phase of the cardiac cycle of the patient for the selected roadmap.” [0021], “The X-ray angiography image sequence may comprise multiple frames covering one or more phases of the cardiac cycle. Throughout this patent application, a cardiac cycle is specific to a patent and is defined as the period in which covers one heartbeat of the patient. The cardiac cycle can be defined as the period of time between successive R-tops within the ECG signal of the patient. A phase refers to a moment (or period) of time within the cardiac cycle of the patient. Phase can be measured as an offset from R-top within the ECG signal of the patient as shown in FIG. 9 and its corresponding description.” [0105]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh in view of Seo Joon as outlined above with the motion of the object under examination comprises a cardiac motion, and wherein the first physiological phase is specified as a diastolic phase of the cardiac motion as taught by Waslum, because it can provide support for the clinician in improved patient treatment [0190].
Regarding Claim 9, Mahesh in view of Seo Joon discloses all limitations noted above except that the medical object contains at least one marker structure, and wherein the determining of the positioning information comprises identification of a mapping of the at least one marker structure.
However, in a similar field of endeavor, Waslum teaches that the medical object contains at least one marker structure, and wherein the determining of the positioning information comprises identification of a mapping of the at least one marker structure (“In this case it is assumed that a device is present inside the vessel of interest which contains radiopaque markers. This can be for instance an un-deployed stent, a measurement guidewire, or any other device which moves synchronic with the movement of the vessel of interest. Within FIG. 32, 3202 an example is provided of an un-deployed stent. Step 2803 is not applicable for X-ray fluoroscopic image sequence and step 2804 now detect and traces the radiopaque markers within the X-ray fluoroscopic image sequence. Since all image frames within the X-ray fluoroscopic image sequence are fluoroscopic image frames, step 2805 is not applicable. Within step 2806, the traced radiopaque markers are used to register the images to each other, and step 2807 is identical as described before. FIG. 32 provides a visual illustration, in which the enhanced calcified plaque image is superimposed on an x-ray angiographic image frame aligned by means of ECG with the enhanced calcified plaque image. Image 3202 shows a single image frame within the X-ray fluoroscopic image sequence, and image 3203 is shows the result of the enhanced calcified plaque image. Image 3201 shows an x-ray angiographic image frame aligned by means of its ECG with the image 3203. Image 3204 shows the result of subtraction the enhanced calcified plaque image from the x-ray angiographic image frame, and image 3205 shows the result of dividing the enhanced calcified plaque by the x-ray angiographic image frame. In both images 3204 and 3205, the calcified plaque location and amount of visible with respect to the vessel lumen.” [0292]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh in view of Seo Joon as outlined above with the medical object contains at least one marker structure, and wherein the determining of the positioning information comprises identification of a mapping of the at least one marker structure as taught by Waslum, because it can provide support for the clinician in improved patient treatment [0190].
Regarding Claim 11, Mahesh in view of Seo Joon discloses all limitations noted above except that the acquiring of the first monitoring image takes place with an acquisition geometry that corresponds to an acquisition geometry of the first planning image in respect of the object under examination, wherein the acquisition geometry of the first monitoring image and the acquisition geometry of the first planning image each comprises a spatial arrangement, a mapping window, an aperture angle, or combination thereof of a medical imaging device.
However, in a similar field of endeavor, Waslum teaches that the acquiring of the first monitoring image takes place with an acquisition geometry that corresponds to an acquisition geometry of the first planning image in respect of the object under examination, wherein the acquisition geometry of the first monitoring image and the acquisition geometry of the first planning image each comprises a spatial arrangement, a mapping window, an aperture angle, or combination thereof of a medical imaging device (“During the online phase, represented by block 110 in FIG. 1, the dynamic roadmapping is actually performed. In the online phase, a sequence of X-ray fluoroscopic image data is acquired without the use of contrast agent and preferably at the same view angles (C-arm angulation and C-arm rotation) as the roadmaps were created during the offline phase (see step 104 of FIG. 1). At the same time, ECG signals are obtained along with the X-ray fluoroscopic image data and compared with the stored ECG to select the best matching roadmap (step 105 in FIG. 1) as created in the offline phase. This is to compensate the change of vessel shape and position between frames due to cardiac motion. Simultaneously, the device location (e.g. catheter tip location) in the acquired X-ray fluoroscopic image data is tracked using image processing techniques and in a preferred embodiment using the proposed deep learning based Bayesian filtering method as described in step 106 in FIG. 1. The displacement of device location (e.g., catheter tip) between the current frame of X-ray fluoroscopic image data and the reference point (device location) associated with the selected roadmap is obtained and applied to transform the selected roadmap to generate a dynamic roadmap as described by step 107 of FIG. 1.” [0120], “The X-ray fluoroscopic images are acquired sequentially with the same projection (view angle) as used during the offline phase (100) by step 101. Using the same projection guarantees that the object of interest and the roadmap have the same orientation as the X-ray angiographic image sequence (101), which was used to generate the roadmaps (103).” [0148]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh in view of Seo Joon as outlined above with the acquiring of the first monitoring image takes place with an acquisition geometry that corresponds to an acquisition geometry of the first planning image in respect of the object under examination, wherein the acquisition geometry of the first monitoring image and the acquisition geometry of the first planning image each comprises a spatial arrangement, a mapping window, an aperture angle, or combination thereof of a medical imaging device as taught by Waslum, because it can provide support for the clinician in improved patient treatment [0190].
Regarding Claim 12, Mahesh in view of Seo Joon discloses all limitations noted above except that the acquiring of the first monitoring image takes place with an acquisition geometry that corresponds to an acquisition geometry of the first planning image in respect of the object under examination, wherein the acquisition geometry of the first monitoring image and the acquisition geometry of the first planning image each comprises a spatial arrangement, a mapping window, an aperture angle, or combination thereof of a medical imaging device.
However, in a similar field of endeavor, Waslum teaches that the first planning image maps a contrasted hollow organ of the object under examination, and wherein, during the acquiring of the first monitoring image, the medical object is arranged at least partially in the contrasted hollow organ (“An embodiment is now disclosed with reference to FIG. 1. The therein-depicted operations can, obviously, be performed in any logical sequence and can be omitted in parts. As it is an objective of the application to provide a workflow that can be used during the interventions, workflow example steps will also be referenced. In a preferred embodiment, the method of this application assumes a scenario of performing dynamic coronary roadmapping to guide a PCI procedure. As can be seen in FIG. 1, the workflow comprises of number of steps which represents an offline phase and an online phase. The offline phase, represented by block 100 in FIG. 1, creates a set of coronary artery roadmaps using an X-ray angiography sequence obtained with injection of contrast agent over multiple cardiac phases. The online phase, represented by block 110 in FIG. 1, uses the set of roadmaps created in the offline phase in conjunction with an X-ray angiography sequence obtained without injection of contrast agent to create a dynamic roadmap based on tracking the position of a device. A visual representation of the dynamic roadmap is overlaid on the live fluoroscopic image stream of the X-ray fluoroscopic image sequence in order to provide visual guidance to the physician to provide support for placement of one or more medical instruments inserted through a guiding catheter. For example, the medical instrument(s) can be a guidewire, dilation balloon, stent or other suitable intravascular device or instrument” [0116], “A roadmap includes information that characterizes properties of the coronary arteries for a given phase of the cardiac cycle. Such information can include centerlines for the coronary arteries, contours (luminal boundary) of the coronary arteries over respective lengths of the coronary arteries, and/or a mask image that represents the coronary arteries (e.g., an image that covers the space occupied by the coronary arteries).” [0118], “A device location (e.g. the catheter tip location) within the X-ray angiography sequence is obtained and associated with the roadmaps to serve as a reference point for roadmap transformation (as described in more detail by step 107 of FIG. 1).” [0119]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh in view of Seo Joon as outlined above with the first planning image maps a contrasted hollow organ of the object under examination, and wherein, during the acquiring of the first monitoring image, the medical object is arranged at least partially in the contrasted hollow organ as taught by Waslum, because it can provide support for the clinician in improved patient treatment [0190].
Regarding Claim 13, Mahesh in view of Seo Joon discloses all limitations noted above except that the acquiring of the first monitoring image and the providing of the result data set are executed repeatedly.
However, in a similar field of endeavor, Waslum teaches that the acquiring of the first monitoring image and the providing of the result data set are executed repeatedly (“ the operations of iii) to vi) can be repeated for successive frames of a live image sequence acquired without a contrast agent.” [0035]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh in view of Seo Joon as outlined above with the acquiring of the first monitoring image and the providing of the result data set are executed repeatedly as taught by Waslum, because it can provide support for the clinician in improved patient treatment [0190].
Regarding Claim 15, Mahesh in view of Seo Joon discloses all limitations noted above except that a motion correction for a compensation of a further motion of the object under examination is applied to the first planning image and the first monitoring image.
However, in a similar field of endeavor, Waslum teaches that a motion correction for a compensation of a further motion of the object under examination is applied to the first planning image and the first monitoring image (“ the operations of v) apply a transformation to the roadmap selected in iii) in order to compensate for motion between the first image data and the second image data. For example, the motion can include breathing motion and/or cardiac motion and/or patient motion and/or table motion.” [0027]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh in view of Seo Joon as outlined above with a motion correction for a compensation of a further motion of the object under examination is applied to the first planning image and the first monitoring image as taught by Waslum, because it can provide support for the clinician in improved patient treatment [0190].
Regarding Claim 16, Mahesh in view of Seo Joon discloses all limitations noted above except that the further motion of the object under examination comprises a respiratory motion of the object under examination.
However, in a similar field of endeavor, Waslum teaches that the further motion of the object under examination comprises a respiratory motion of the object under examination (“the operations of v) apply a transformation to the roadmap selected in iii) in order to compensate for motion between the first image data and the second image data. For example, the motion can include breathing motion and/or cardiac motion and/or patient motion and/or table motion.” [0027]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh in view of Seo Joon as outlined above with the further motion of the object under examination comprises a respiratory motion of the object under examination as taught by Waslum, because it can provide support for the clinician in improved patient treatment [0190].
Regarding Claim 17, Mahesh in view of Seo Joon discloses all limitations noted above except that a predefined section of the medical object is mapped in the first planning image and the first monitoring image, and wherein the motion correction is based on a shared mapping of the predefined section in the first planning image and the first monitoring image.
However, in a similar field of endeavor, Waslum teaches that a predefined section of the medical object is mapped in the first planning image and the first monitoring image, and wherein the motion correction is based on a shared mapping of the predefined section in the first planning image and the first monitoring image (“A device location (e.g. the catheter tip location) within the X-ray angiography sequence is obtained and associated with the roadmaps to serve as a reference point for roadmap transformation (as described in more detail by step 107 of FIG. 1). This reference point (device location), as described in more detail by step 102 of FIG. 1, can be integrated into the roadmaps.” [0119], “As described herein, a reference point can be used to compensate for motion between the roadmaps obtained from the X-ray angiographic image sequence (offline phase) with the X-ray fluoroscopic image stream (online phase). The reference point, which can be extracted from the device location, can be any object in which its motion can be correlated to the breathing motion and patient motion and the device can be for example the catheter tip, pacemaker or an anatomical landmarks. Within a preferred embodiment the device is a guiding catheter and the device location is the guiding catheter tip. Within step 107, the location of the device (e.g. catheter tip) in current X-ray fluoroscopic frame, as a result of step 106, and the device location (e.g. catheter tip) from the selected roadmap frame as a result of step 105 is used to obtain a transformation function to align the selected roadmap with the current X-ray fluoroscopic image frame. In embodiments, this transformation function might be a rigid transformation based on the displacement obtained from the catheter tip between the current frame and the catheter tip within the selected roadmap frame. Alternatively, the transformation function can be a non-rigid transformation.” [0184]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh in view of Seo Joon as outlined above with the medical object is mapped in the first planning image and the first monitoring image, and wherein the motion correction is based on a shared mapping of the predefined section in the first planning image and the first monitoring image as taught by Waslum, because it can provide support for the clinician in improved patient treatment [0190].
Regarding Claim 18, Mahesh in view of Seo Joon discloses all limitations noted above except that multiple planning images are provided that map multiple physiological phases of the motion of the object under examination, wherein multiple monitoring images are acquired that map at least one part of the multiple physiological phases of the motion of the object under examination and the medical object arranged in the object under examination, and wherein the first planning image is identified from the multiple planning images, and the first monitoring image from the multiple monitoring images, such that the first planning image and the first monitoring image map the first physiological phase as a coincident physiological phase of the motion.
However, in a similar field of endeavor, Waslum teaches that multiple planning images are provided that map multiple physiological phases of the motion of the object under examination, (“The offline phase, represented by block 100 in FIG. 1, is performed before the actual roadmapping is conducted. In the offline phase, roadmaps of coronary arteries over multiple phases of the cardiac cycle are created from an X-ray angiographic image sequence that covers the multiple phases of the cardiac cycle. Typically, at least one cardiac cycle is taken into account. Along with the X-ray angiography sequence, temporal information (e.g. ECG signals) of the cardiac cycle are obtained and stored. A roadmap includes information that characterizes properties of the coronary arteries for a given phase of the cardiac cycle.” [0118]),
wherein multiple monitoring images are acquired that map at least one part of the multiple physiological phases of the motion of the object under examination and the medical object arranged in the object under examination, and wherein the first planning image is identified from the multiple planning images, and the first monitoring image from the multiple monitoring images, such that the first planning image and the first monitoring image map the first physiological phase as a coincident physiological phase of the motion ( “After retrieving fluoroscopic images including ECG signal as described by step 104, a roadmap from the selection of roadmaps (which are created in step 103) is selected for every single fluoroscopic image. Roadmap selection represented by step 104 in FIG. 1 can be achieved by comparing the ECG signal associated with the online fluoroscopic image and the ECG of the offline angiographic sequence, such that the most suitable candidate roadmap is selected where the best match of the ECG signals is found. The selected roadmap has the same (or very similar) cardiac phase with the online X-ray fluoroscopic image, which compensates the difference of vessel shape and pose induced by cardiac motion.” [0149-0150]).
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh in view of Seo Joon as outlined above with multiple planning images are provided that map multiple physiological phases of the motion of the object under examination, wherein multiple monitoring images are acquired that map at least one part of the multiple physiological phases of the motion of the object under examination and the medical object arranged in the object under examination, and wherein the first planning image is identified from the multiple planning images, and the first monitoring image from the multiple monitoring images, such that the first planning image and the first monitoring image map the first physiological phase as a coincident physiological phase of the motion as taught by Waslum, because it can provide support for the clinician in improved patient treatment [0190].
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Mahesh in view of Seo Joon and further in view of Walsum as applied to Claim 9 above, and further in view of Chen et al (US20140079308A1; hereinafter referred to as Chen)
Regarding Claim 10, Mahesh in view of Seo Joon and further in view of Waslum discloses all limitations noted above except that the medical object contains a spatial arrangement of multiple marker structures, wherein the planning information contains a planning positioning in the object under examination for the spatial arrangement of the multiple marker structures, and wherein the determining of the positioning information comprises identification of a mapping of the spatial arrangement of the multiple marker structures.
However, in a similar field of endeavor, Chen teaches a method and system for real time stent enhancement on a live 2D fluoroscopic scene [Abstract].
Chen also teaches the medical object contains a spatial arrangement of multiple marker structures, wherein the planning information contains a planning positioning in the object under examination for the spatial arrangement of the multiple marker structures, and wherein the determining of the positioning information comprises identification of a mapping of the spatial arrangement of the multiple marker structures (“At step 104, a pair of balloon markers are detected in each frame of the first set of frames. Balloon markers are radiopaque markers at the proximal and distal ends of a stent. The pair of balloon markers is detected in each frame of the first set of frames, and the detected balloon markers can then be used to compensate for motion in the first set of frames.” [0022], “The only semantic ground truth is that both of the balloon markers must be located on the guidewire. According to an advantageous embodiment, the guidewire can be detected directly in each frame using a trained classifier that directly locates wire structures. FIG. 3 illustrates a target detection model for detecting the balloon markers and the guidewire according to an embodiment of the present invention. As shown in image (A) of FIG. 3, the target pattern to be detected is modeled as a marker pair connected by a thin guidewire. Because the balloon is covered by a stent inside the coronary and there is a limitation of the length of the stent, the degree of guidewire information is limited. As a result, the marker guidewire combination can be modeled as:” [0025])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Mahesh in view of Seo Joon and further in view of Waslum as outlined above with the medical object contains a spatial arrangement of multiple marker structures, wherein the planning information contains a planning positioning in the object under examination for the spatial arrangement of the multiple marker structures, and wherein the determining of the positioning information comprises identification of a mapping of the spatial arrangement of the multiple marker structures as taught by Chen, because it can improve the image quality for better stent visibility [0004].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN MALDONADO whose telephone number is 703-756-1421. The examiner can normally be reached 8:00 am-4:00 pm PST M-Th Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at
http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached on (571) 272-7230. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Steven Maldonado/
Patent Examiner, Art Unit 3797
/MICHAEL T ROZANSKI/ Primary Examiner, Art Unit 3797