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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP22180236.6, filed on 06/21/2022.
Preliminary Amendment
The Preliminary Amendment submitted on 12/20/2024 has been entered and made of record.
Status of Claims
Currently pending Claim(s):
Canceled claim(s):
New Claim(s):
13-15
1-12
13-15
Drawings
The drawings are objected to because the unlabeled rectangular box(es) shown in the drawings, Figures 4-7, should be provided with descriptive text labels. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 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 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al (US 6,470,207 B1) (hereinafter, “Simon”) in view of Siewerdsen et al. (US 10,426,554 B2) (hereinafter, “Siewerdsen”).
Regarding claim 13, Simon discloses a method for validating a 3D position and 3D orientation of a first object (instrument 140 in Column 8 [lines 11-19] equates to first object) relative to a second object (reference frame 150 or patient’s anatomy in Column 8 [lines 11-19] equate to a second object), the method comprising the steps of determining a 3D position and 3D orientation of the first object relative to the second object at a first point in time (Column 8 [lines 11-19] "when inserting a screw into the spine of patient 110, dynamic reference frame marker 150 may be physically attached to a portion of the spine of the patient. Because dynamic reference frame 150 is in a fixed position relative to the patient anatomy, and instrument 140 can be accurately located in three dimensional space relative to dynamic reference frame 150, instrument 140 can also be located relative to the patient's anatomy."; Column 9 [lines 48-50] "The physician can use image 500 and overlay 502 to visualize the position and orientation of the surgical tool relative to the patient's anatomy.");
determining a 3D position and 3D orientation of the first object (instrument 140 in Column 9 [lines 22-27] equate to first object) relative to the second object (dynamic reference frame and patient in Column 9 [lines 22-27] equate to second object) at a second point in time based on information received from a real-time tracking system (tracking sensor 130 equates to real-time tracking system) (Column 7 [lines 45-46] "Tracking sensor 130 is a real-time infrared tracking sensor linked to computer 120."; Column 9 [lines 22-27] "During surgery, tracking sensor 130 and computer 120 detect the position of instrument 140 relative to dynamic reference frame 150, and hence relative to patient 110. With this information, computer 120 dynamically calculates, in real-time, the projection of instrument 140 into each fluoroscopic image as the instrument is moved by the physician."; Column 9 [lines 56-65] “Computer 120 may vary the length of look-ahead trajectory 505 as directed by the physician…computer 120 assists the physician in visualizing where the instrument would be in the patient…”);
receiving a 2D X-ray image generated at the second point in time by an X-ray imaging device, the 2D X-ray image depicting at least a part of the first object and at least a part of the second object (Column 17 [lines 16-18] "conventional fluoroscope could be used to acquire an image after the inter-vertebral cage has been implanted."; Note fluoroscopy images contain both the vertebrae (i.e. second object) and the spinal implant (i.e. first object) when used after spine surgery);
receiving at least one of 3D data representing the first object or a 3D model (3D CAD model of in Column 17 [lines 1-4] equates to 3D model) of the first object (Column 15 [lines 61-64] “The position of the surgical instrument used to hold the cage during the insertion process, as detected by tracking sensor 130, is used to calculate the position of the cage in FIG. 14A during the two-dimensional navigational process.”; End of Column 16 line 65 continuing to column 17 line 4 "A DRR image may be used to provide guidance to the surgeon in the problem discussed in Example 1 of appropriately placing an inter-vertebral cage in the patient…the physician, interacting with computer 120, may manually position a 3D CAD model of an inter-vertebral cage in a clinically desired position in the three-dimensional view of the vertebrae.");
receiving at least one of 3D data representing (3D CT data in Column 17 equate to the 3D data) the second object or a 3D model of the second object (End of Column 16 line 65 continuing to column 17 line 1 "A DRR image may be used to provide guidance to the surgeon in the problem discussed in Example 1 of appropriately placing an inter-vertebral cage in the patient. Given a 3D CT data set of two adjacent vertebrae…");
generating a virtual projection image based on (i) the 3D data representing the first object or the 3D model of the first object (3D CAD model in Column 17 equates to 3D model), (ii) the 3D data representing the second object (3D CT data set in Column 17 equate to the 3D data) or the 3D model of the second object, and [(iii) the 3D position and 3D orientation of the first object relative to the second object at the second point in time based on the information received from the real-time tracking system] (End of Column 16 line 65 continuing to column 17 line 10 "A DRR image may be used to provide guidance to the surgeon in the problem discussed in Example 1 of appropriately placing an inter-vertebral cage in the patient. Given a 3D CT data set of two adjacent vertebrae, the physician, interacting with computer 120, may manually position a 3D CAD model of an inter-vertebral cage in a clinically desired position in the three-dimensional view of the vertebrae. The physician may then use the DRR technique to synthesize an anterior/posterior, lateral, or other x-ray view of the vertebrae showing the three-dimensional CAD model of the inter-vertebral cage. Thus, a synthetic fluoroscopic x-ray image can be created which simulates what a properly placed cage would look like after implantation.”) and
comparing the 2D X-ray image (actual images taken by the imager in Column 17 [lines 11-14] equate to the 2D X-ray image) and the virtual projection image (simulated x-ray images in Column 17 [lines 11-14] equate to the virtual projection image) (Column 17 [lines 11-14] “The simulated x-ray images may be compared to the actual images taken by imager 100 during surgery. The goal of the surgeon is to position the implant such that the intra-operative images match the DRR images.”).
However, Simon fails to teach [generating a virtual projection image] based on (iii) the 3D position and 3D orientation of the first object relative to the second object at the second point in time based on the information received from the real-time tracking system.
Siewerdsen teaches [generating a virtual projection image] based on (iii) the 3D position and 3D orientation of the first object (tool T in Column 6 [lines 15-27] and Fig. 3B equates to the first object) relative to the second object (preoperative CT or intraoperative CBCT in Column 9 [lines 30] equate to the second object) at the second point in time based on the information received from the real-time tracking system (Column 6 [lines 15-27] “Real-time visualization of surgical instruments (e.g., pointers, suctions, drills, and endoscopes) with respect to images or planning data in image-guided surgery assists the surgeon in achieving precise approach and excision/ablation of a surgical target while respecting surrounding normal tissues. Typical tracking systems localize specific markers mounted on or integrated into various surgical instruments…video-based trackers measure the pose of specific markers 28 (e.g., X-points) attached to the tool T”; Column 9 line 58 continuing to column 10 line 4 “Real-time DRR capabilities made possible by the system may also assist the surgeon in C-arm setup and radiographic search/localization of target anatomy without x-ray exposure….Since virtual fluoroscopy can be computed from either preoperative CT or intraoperative CBCT (typically the former), it can be used even in complex patient setups that challenge or prohibit 180° rotation of the C-arm for CBCT acquisition”).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date to modify Simon’s reference to include [generating a virtual projection image] based on (iii) the 3D position and 3D orientation of the first object relative to the second object at the second point in time based on the information received from the real-time tracking system taught by Siewerdsen’s reference. The motivation for doing so would have been to reduce the setup time and the amount of X-ray exposure during the targeting process as suggested by Siewerdsen (see Siewerdsen, Column 7 [lines 57-60]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine Siewerdsen with Simon to obtain the invention specified in claim 13.
Regarding claim 14, Simon discloses a device for validating a 3D position and 3D orientation of a first object relative to a second object, the device comprising a processing unit configured to (Column 20 [lines 44-59 “the memory including computer instructions that when executed by the computer processor cause the processor to generate an icon representing the surgical instrument and to overlay the icon on a pre-acquired x-ray image…the icon being generated as a second representation when the surgical instrument is positioned such that it is substantially perpendicular to the plane of the pre-acquired image.”):
determine a 3D position and 3D orientation of the first object relative (instrument 140 in Column 8 [lines 11-19] equates to first object) to the second object (reference frame 150 or patient’s anatomy in Column 8 [lines 11-19] equate to a second object) at a first point in time (Column 8 [lines 11-19] "when inserting a screw into the spine of patient 110, dynamic reference frame marker 150 may be physically attached to a portion of the spine of the patient. Because dynamic reference frame 150 is in a fixed position relative to the patient anatomy, and instrument 140 can be accurately located in three dimensional space relative to dynamic reference frame 150, instrument 140 can also be located relative to the patient's anatomy."; Column 9 [lines 48-50] "The physician can use image 500 and overlay 502 to visualize the position and orientation of the surgical tool relative to the patient's anatomy.");
determine a 3D position and 3D orientation of the first object (instrument 140 in Column 9 [lines 22-27] equate to first object) relative to the second object (dynamic reference frame and patient in Column 9 [lines 22-27] equate to second object) at a second point in time based on information received from a real-time tracking system (Column 7 [lines 45-46] "Tracking sensor 130 is a real-time infrared tracking sensor linked to computer 120."; Column 9 [lines 22-27] "During surgery, tracking sensor 130 and computer 120 detect the position of instrument 140 relative to dynamic reference frame 150, and hence relative to patient 110. With this information, computer 120 dynamically calculates, in real-time, the projection of instrument 140 into each fluoroscopic image as the instrument is moved by the physician."; Column 9 [lines 56-65] “Computer 120 may vary the length of look-ahead trajectory 505 as directed by the physician…computer 120 assists the physician in visualizing where the instrument would be in the patient…”);
receive a 2D X-ray image generated at the second point in time by an X-ray imaging device, the 2D X-ray image depicting at least a part of the first object and at least a part of the second object (Column 17 [lines 16-18] "conventional fluoroscope could be used to acquire an image after the inter-vertebral cage has been implanted."; Note fluoroscopy images contain both the vertebrae (i.e. second object) and the spinal implant (i.e. first object) when used after spine surgery);
receive at least one of 3D data representing the first object or a 3D model (3D CAD model in Column 17 [lines 1-4] equates to 3D model) of the first object (Column 15 [lines 61-64] “The position of the surgical instrument used to hold the cage during the insertion process, as detected by tracking sensor 130, is used to calculate the position of the cage in FIG. 14A during the two-dimensional navigational process.”; End of Column 16 line 65 continuing to column 17 line 4 "A DRR image may be used to provide guidance to the surgeon in the problem discussed in Example 1 of appropriately placing an inter-vertebral cage in the patient…the physician, interacting with computer 120, may manually position a 3D CAD model of an inter-vertebral cage in a clinically desired position in the three-dimensional view of the vertebrae.");
receive at least one of 3D data (3D CT data Column 17 equate to the 3D data) representing the second object or a 3D model of the second object (End of Column 16 line 65 continuing to column 17 line 1 "A DRR image may be used to provide guidance to the surgeon in the problem discussed in Example 1 of appropriately placing an inter-vertebral cage in the patient. Given a 3D CT data set of two adjacent vertebrae");
generate a virtual projection image based on (i) the 3D data representing the first object or the 3D model of the first object (3D CAD model of an inter-vertebral cage in Column 17 equates to 3D model of the first object), (ii) the 3D data representing the second object or the 3D model of the second object (3D CT data set of the vertebrae in Column 17 equate to the 3D data representing the second object), and (iii) the 3D position and 3D orientation of the first object relative to the second object at the second point in time based on the information received from the real-time tracking system (End of Column 16 line 65 continuing to column 17 line 10 "A DRR image may be used to provide guidance to the surgeon in the problem discussed in Example 1 of appropriately placing an inter-vertebral cage in the patient. Given a 3D CT data set of two adjacent vertebrae, the physician, interacting with computer 120, may manually position a 3D CAD model of an inter-vertebral cage in a clinically desired position in the three-dimensional view of the vertebrae. The physician may then use the DRR technique to synthesize an anterior/posterior, lateral, or other x-ray view of the vertebrae showing the three-dimensional CAD model of the inter-vertebral cage. Thus, a synthetic fluoroscopic x-ray image can be created which simulates what a properly placed cage would look like after implantation.”), and
compare the 2D X-ray image (actual images taken by the imager equate to the 2D X-ray image) and the virtual projection image (simulated x-ray images in Column 17 [lines 11-14] equate to the virtual projection image) (Column 17 [lines 11-14] “The simulated x-ray images may be compared to the actual images taken by imager 100 during surgery. The goal of the surgeon is to position the implant such that the intra-operative images match the DRR images.”).
However, Simon fails to teach [generate a virtual projection image] based on (iii) the 3D position and 3D orientation of the first object relative to the second object at the second point in time based on the information received from the real-time tracking system.
Siewerdsen teaches [generate a virtual projection image] based on (iii) the 3D position and 3D orientation of the first object (tool T in Column 6 [lines 15-27] and Fig. 3B equates to the first object) relative to the second object (preoperative CT or intraoperative CBCT in Column 9 [lines 30] equate to the second object) in Column 6 and 9 equate to the second object equate to the second object) at the second point in time based on the information received from the real-time tracking system (Column 6 [lines 15-27] “Real-time visualization of surgical instruments (e.g., pointers, suctions, drills, and endoscopes) with respect to images or planning data in image-guided surgery assists the surgeon in achieving precise approach and excision/ablation of a surgical target while respecting surrounding normal tissues. Typical tracking systems localize specific markers mounted on or integrated into various surgical…video-based trackers measure the pose of specific markers 28 (e.g., X-points) attached to the tool T”; Column 9 line 58 continuing to column 10 line 4 “Real-time DRR capabilities made possible by the system may also assist the surgeon in C-arm setup and radiographic search/localization of target anatomy without x-ray exposure….Since virtual fluoroscopy can be computed from either preoperative CT or intraoperative CBCT (typically the former), it can be used even in complex patient setups that challenge or prohibit 180° rotation of the C-arm for CBCT acquisition”).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date to modify Simon’s reference to include [generate a virtual projection image] based on (iii) the 3D position and 3D orientation of the first object relative to the second object at the second point in time based on the information received from the real-time tracking system taught by Siewerdsen’s reference. The motivation for doing so would have been to reduce the setup time and the amount of X-ray exposure during the targeting process as suggested by Siewerdsen (see Siewerdsen, Column 7 [lines 57-60]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine Siewerdsen with Simon to obtain the invention specified in claim 14.
Regarding claim 15, Simon discloses non-transitory computer readable medium comprising processor-executable instructions validating a 3D position and 3D orientation of a first object relative to a second object, the processor-executable instructions when executed on the processor in a device configure the device to (Column 20 [lines 44-59 “the memory including computer instructions that when executed by the computer processor cause the processor to generate an icon representing the surgical instrument and to overlay the icon on a pre-acquired x-ray image…the icon being generated as a second representation when the surgical instrument is positioned such that it is substantially perpendicular to the plane of the pre-acquired image.”):
determine a 3D position and 3D orientation of the first object (instrument 140 in Column 8 [lines 11-19] equates to first object) relative to the second object (reference frame 150 or patient’s anatomy in Column 8 [lines 11-19] equate to a second object) at a first point in time (Column 8 [lines 11-19] "when inserting a screw into the spine of patient 110, dynamic reference frame marker 150 may be physically attached to a portion of the spine of the patient. Because dynamic reference frame 150 is in a fixed position relative to the patient anatomy, and instrument 140 can be accurately located in three dimensional space relative to dynamic reference frame 150, instrument 140 can also be located relative to the patient's anatomy."; Column 9 [lines 48-50] "The physician can use image 500 and overlay 502 to visualize the position and orientation of the surgical tool relative to the patient's anatomy.");
determine a 3D position and 3D orientation of the first object (instrument 140 in Column 9 [lines 22-27] equate to first object) relative to the second object (dynamic reference frame and patient in Column 9 [lines 22-27] equate to second object) at a second point in time based on information received from a real-time tracking system (Column 7 [lines 45-46] "Tracking sensor 130 is a real-time infrared tracking sensor linked to computer 120."; Column 9 [lines 22-27] "During surgery, tracking sensor 130 and computer 120 detect the position of instrument 140 relative to dynamic reference frame 150, and hence relative to patient 110. With this information, computer 120 dynamically calculates, in real-time, the projection of instrument 140 into each fluoroscopic image as the instrument is moved by the physician."; Column 9 [lines 56-65] “Computer 120 may vary the length of look-ahead trajectory 505 as directed by the physician…computer 120 assists the physician in visualizing where the instrument would be in the patient…”);
receive a 2D X-ray image generated at the second point in time by an X-ray imaging device, the 2D X-ray image depicting at least a part of the first object and at least a part of the second object (Column 17 [lines 16-18] "conventional fluoroscope could be used to acquire an image after the inter-vertebral cage has been implanted."; Note fluoroscopy images contain both the vertebrae (i.e. second object) and the spinal implant (i.e. first object) when used after spine surgery);
receive at least one of 3D data representing the first object or a 3D model (3D CAD model of in Column 17 [lines 1-4] equates to 3D model) of the first object (Column 15 [lines 61-64] “The position of the surgical instrument used to hold the cage during the insertion process, as detected by tracking sensor 130, is used to calculate the position of the cage in FIG. 14A during the two-dimensional navigational process.”; End of Column 16 line 65 continuing to column 17 line 4 "A DRR image may be used to provide guidance to the surgeon in the problem discussed in Example 1 of appropriately placing an inter-vertebral cage in the patient…the physician, interacting with computer 120, may manually position a 3D CAD model of an inter-vertebral cage in a clinically desired position in the three-dimensional view of the vertebrae.");
receive at least one of 3D data (3D CT data set of the vertebrae in Column 17 equate to the 3D data representing the second object) representing the second object or a 3D model of the second object (End of Column 16 line 65 continuing to column 17 line 1 "A DRR image may be used to provide guidance to the surgeon in the problem discussed in Example 1 of appropriately placing an inter-vertebral cage in the patient. Given a 3D CT data set of two adjacent vertebrae");
generate a virtual projection image based on (i) the 3D data representing the first object or the 3D model of the first object (3D CAD model in Column 17 equates to 3D model), (ii) the 3D data representing the second object or the 3D model of the second object (3D CT data set in Column 17 equate to the 3D data), and [(iii) the 3D position and 3D orientation of the first object relative to the second object at the second point in time based on the information received from the real-time tracking system] (End of Column 16 line 65 continuing to column 17 line 10 "A DRR image may be used to provide guidance to the surgeon in the problem discussed in Example 1 of appropriately placing an inter-vertebral cage in the patient. Given a 3D CT data set of two adjacent vertebrae, the physician, interacting with computer 120, may manually position a 3D CAD model of an inter-vertebral cage in a clinically desired position in the three-dimensional view of the vertebrae. The physician may then use the DRR technique to synthesize an anterior/posterior, lateral, or other x-ray view of the vertebrae showing the three-dimensional CAD model of the inter-vertebral cage. Thus, a synthetic fluoroscopic x-ray image can be created which simulates what a properly placed cage would look like after implantation.”), and
compare the 2D X-ray image (actual images taken by the imager in Column 17 [lines 11-14] equate to the 2D X-ray image) and the virtual projection image (simulated x-ray images in Column 17 [lines 11-14] equate to the virtual projection image) (Column 17 [lines 11-14] “The simulated x-ray images may be compared to the actual images taken by imager 100 during surgery. The goal of the surgeon is to position the implant such that the intra-operative images match the DRR images.”).
However, Simon fails to teach [generate a virtual projection image] based on (iii) the 3D position and 3D orientation of the first object relative to the second object at the second point in time based on the information received from the real-time tracking system.
Siewerdsen teaches [generate a virtual projection image] based on (iii) the 3D position and 3D orientation of the first object (tool T in Column 6 [lines 15-27] and Fig. 3B equates to the first object) relative to the second object (preoperative CT or intraoperative CBCT in Column 9 [lines 30] equate to the second object) at the second point in time based on the information received from the real-time tracking system (Column 6 [lines 15-27] “Real-time visualization of surgical instruments (e.g., pointers, suctions, drills, and endoscopes) with respect to images or planning data in image-guided surgery assists the surgeon in achieving precise approach and excision/ablation of a surgical target while respecting surrounding normal tissues. Typical tracking systems localize specific markers mounted on or integrated into various surgical…video-based trackers measure the pose of specific markers 28 (e.g., X-points) attached to the tool T”; Column 9 line 58 continuing to column 10 line 4 “Real-time DRR capabilities made possible by the system may also assist the surgeon in C-arm setup and radiographic search/localization of target anatomy without x-ray exposure….Since virtual fluoroscopy can be computed from either preoperative CT or intraoperative CBCT (typically the former), it can be used even in complex patient setups that challenge or prohibit 180° rotation of the C-arm for CBCT acquisition”).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date to modify Simon’s reference to include [generate a virtual projection image] based on (iii) the 3D position and 3D orientation of the first object relative to the second object at the second point in time based on the information received from the real-time tracking system taught by Siewerdsen’s reference. The motivation for doing so would have been to reduce the setup time and the amount of X-ray exposure during the targeting process as suggested by Siewerdsen (see Siewerdsen, Column 7 [lines 57-60]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine Siewerdsen with Simon to obtain the invention specified in claim 15.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dahan et al. (US 2023/0240755 A1) discloses a system for registering anatomical elements by using a navigation system to obtain marker pose information and object identification, and inputting image data, pose information, and object identification in a registration model.
Haase et al. (US 2021/0012545 A1) discloses correcting motion artifacts in cone-beam CT imaging by identifying relative motion between rigid anatomical objects during acquisition and using the motion to correct projection images.
Mertelmeier et al. (US 2020/0100750 A1) discloses monitoring tissue removal using an X-ray imaging system by reconstructing X-ray projection scan data and determining the current lesion position relative to a reference coordinate system.
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/UROOJ FATIMA/Examiner, Art Unit 2676
/Henok Shiferaw/Supervisory Patent Examiner, Art Unit 2676
