DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s amendments merit new grounds for rejection in view of Johnson et al. (U.S. Patent Application Publication No. 2017/0215827).
Johnson teaches a mobile, C-arm apparatus (Fig. 1) for obtaining CBCT (¶[0036]) using manual rotation (¶[0075] manual control of the gantry, ¶[0077]). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the imaging of Gregerson to use CBCT data obtained from a mobile, C-arm apparatus, as taught by Johnson, because small scale, mobile 3D imaging systems are desirable in multiple healthcare environments (Johnson ¶¶[0004-0005]) and the device of Johnson solves drawback previously attributed to mobile systems (precision of placement and movement, solved by Johnson, ¶¶[0004-0005], ¶¶[0075-0076]).
Applicant’s remarks appear to be solely directed to amended subject matter and are therefore moot in light of the new grounds for rejection.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 69 and 77-88 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gregerson et al. (U.S. Patent Application Publication No. 2020/0268473) hereinafter referred to as Gregerson; in view of Johnson et al. (U.S. Patent Application Publication No. 2017/0215827) hereinafter referred to as Johnson.
Regarding claim 69, Gregerson teaches a method for imaging an anatomic region (¶[0031], ¶[0040] patient anatomy), the method comprising:
generating a 3D cone-beam computed tomography (CBCT) (¶[0034], ¶[0043], it is the examiner’s understanding that a CBCT is a C-arm CT as the C-arm uses a cone beam for 3D reconstruction) reconstruction (¶[0032] three-dimensional reconstruction) of an anatomic region from first image data obtained using a detector carried by an imaging arm (¶[0032], ¶[0034]) of an imaging apparatus (¶[0034] imaging apparatus may be mobile and may be a C-arm, etc., ¶[0043] from imaging device, three-dimensional dataset of a reconstruction representing patient anatomy), wherein the first image data is obtained during manual rotation of the imaging arm of the imaging apparatus (¶¶[0068-0069], ¶[0084] manually movable arm);
identifying a target structure in the 3D CBCT reconstruction (¶[0070] target location, ¶[0087] particular anatomic features, such as a bony structure);
receiving second image data of the anatomic region obtained using the imaging apparatus (¶[0044] second image dataset of the patient and surrounding patient space);
receiving pose data of the imaging arm (¶[0041] imaging device fixed to robotic arm) of the imaging apparatus (¶[0056], ¶[0069] for example, position and orientation with respect to the patient); and
outputting, via the display, a graphical representation of the target structure overlaid onto the second image data, based on the pose data and the 3D CBCT reconstruction (¶¶[0048-0049] show patient anatomy with structures and/or target overlaid on top, based on position of the imaging arm).
While Gregerson teaches that the imaging apparatus may be mobile, and may be a C-arm, Gregerson does not teach a mobile, C-arm apparatus.
Attention is drawn to the Johnson reference, which teaches a mobile, C-arm apparatus (Fig. 1) for obtaining CBCT (¶[0036]) using manual rotation (¶[0075] manual control of the gantry, ¶[0077]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the imaging of Gregerson to use CBCT data obtained from a mobile, C-arm apparatus, as taught by Johnson, because small scale, mobile 3D imaging systems are desirable in multiple healthcare environments (Johnson ¶¶[0004-0005]) and the device of Johnson solves drawback previously attributed to mobile systems (precision of placement and movement, solved by Johnson, ¶¶[0004-0005], ¶¶[0075-0076]).
Regarding claim 77, Gregerson as modified teaches the method of claim 69.
Gregerson teaches further comprising:
generating a 3D model of the target structure (¶[0132]);
determining a current pose of the imaging arm, based on the pose data (¶[0132] in conjunction with tracked position of marker devices); and
generating a 2D projection of the 3D model from a point of view corresponding to the current pose of the imaging arm (¶[0067], ¶[0083]); and
determining a location of the target structure in the second image data, based on the 2D projection (¶[0054], ¶[0084]).
Regarding claim 78, Gregerson as modified teaches the method of claim 69.
Gregerson further teaches wherein the pose data is generated using sensor data from at least one sensor coupled to the imaging arm (¶[0106]).
Regarding claim 79, Gregerson as modified teaches the method of claim 78.
Gregerson further teaches wherein the at least one sensor comprises a motion sensor (¶[0106]).
Regarding claim 80, Gregerson as modified teaches the method of claim 79.
Gregerson further teaches wherein the motion sensor comprises an inertial measurement unit (IMU) (¶[0106]).
Regarding claim 81, Gregerson as modified teaches the method of claim 69.
Gregerson further teaches wherein the 3D CBCT reconstruction is generated during a medical procedure performed on the patient and the second image data is generated during the same medical procedure (¶[0111] “during an image guided procedure”).
Regarding claim 82, Gregerson as modified teaches the method of claim 69.
Gregerson further teaches wherein the 3D CBCT reconstruction is generated without using preoperative image data of the anatomic region (¶[0111] “during an image guided procedure” and ¶[0090] before, during, and/or after, usable in any of these scenarios).
Regarding claim 83, Gregerson as modified teaches the method of claim 69.
Gregerson further teaches wherein identifying the target structure comprises segmenting the target structure in the 3D CBCT reconstruction (¶[0072]).
Regarding claim 84, Gregerson as modified teaches the method of claim 69.
Gregerson further teaches wherein the second image data comprises live fluoroscopic images of the anatomic region (¶[0034] C-arm fluoroscope).
Regarding claim 85, Gregerson as modified teaches the method of claim 69.
Gregerson teaches further comprising updating the graphical representation after the imaging arm is rotated to a different pose (¶[0036]).
Regarding claim 86, Gregerson as modified teaches the method of claim 69.
Gregerson teaches further comprising calibrating the first image data before generating the 3D CBCT reconstruction (¶[0045]).
Regarding claim 87, Gregerson as modified teaches the method of claim 86.
Gregerson further teaches wherein calibrating the first image data includes one or more of (a) applying distortion correction parameters to the first image data or (b) applying geometric calibration parameters to the first image data (¶[0045] transformation between coordinate systems includes at least one of these as a mathematical process including translation, rotation and scaling or shearing).
Regarding claim 88, Gregerson as modified teaches the method of claim 86.
Gregerson teaches further comprising reversing calibration of a 3D model of the target structure generated from the calibrated first image data, before using the 3D model to determine a projected location of the target structure in the second image data (¶[0044] transformation between devices for target structure, ¶[0128]).
Claim(s) 70-71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gregerson and Johnson as applied to claim 69 above, and further in view of Tse et al. (U.S. Patent Application Publication No. 2020/0268460) hereinafter referred to as Tse.
Regarding claims 70-71, Gregerson teaches the method of claim 69.
Gregerson does not teach wherein the imaging arm is stabilized by a shim structure during the manual rotation, wherein the shim structure fills a space between the imaging arm and a support arm of the mobile C-arm imaging apparatus.
Notably, Johnson teaches the mobile C-arm imaging apparatus, as above.
Attention is drawn to the Tse reference, which teaches wherein the imaging arm is stabilized by a shim structure during the manual rotation (Fig. 2E, element 282 shim in a rotational joint, ¶[0105]).
wherein the shim structure fills a space between the imaging arm and a support arm of the imaging apparatus (Figs. 2E-F, Fig. 7C).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the imaging arm and support arm of Gregerson to include a shim, as taught by Tse, for a stable swiveling mechanism, as taught by Tse (¶[0105], ¶[0107]).
Claim(s) 72-73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gregerson and Johnson as applied to claim 69 above, and further in view of Gauvrit et al. (Gauvrit JY, Leclerc X, Vermandel M, Lubicz B, Despretz D, Lejeune JP, Rousseau J, Pruvo JP. 3D rotational angiography: use of propeller rotation for the evaluation of intracranial aneurysms. AJNR Am J Neuroradiol. 2005) hereinafter referred to as Gauvrit.
Regarding claims 72-73, Gregerson teaches the method of claim 69.
Gregerson is silent as to the range or type of rotation.
Attention is drawn to the Gauvrit reference, which teaches wherein the manual rotation comprises a rotation of at least 90 degrees, wherein the manual rotation comprises a propeller rotation (Fig. 2).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the rotation of Gregerson to include propeller rotation comprising at least a 90 degree rotation, as taught by Gauvrit, because propeller rotation is faster, easier to perform, and requires less contrast material without altering image quality (Gauvrit, § Conclusion).
Claim(s) 74-76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gregerson and Johnson as applied to claim 69 above, and further in view of Soper et al. (U.S. Patent Application Publication No. 2019/0038365) hereinafter referred to as Soper.
Regarding claim 74, Gregerson teaches the method of claim 69.
Gregerson is silent as to receiving a plurality of projection images from the imaging apparatus during the manual rotation of the imaging arm; determining pose information of the imaging arm for each projection image; and generating the 3D reconstruction based on the projection images and the pose information.
Notably, Johnson teaches a mobile C-arm apparatus for CBCT, as above.
Attention is drawn to the Soper reference, which teaches wherein generating the 3D reconstruction (¶[0062]) comprises:
receiving a plurality of projection images from the imaging apparatus during the manual rotation of the imaging arm (¶[0074]);
determining pose information of the imaging arm for each projection image (¶[0079]); and
generating the 3D reconstruction based on the projection images and the pose information (¶[0080], ¶[0084]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the imaging of Gregerson to include additional image and pose acquisition for 3D reconstruction, as taught by Soper, because it results in a distortion-free, or distortion-improved image and improves the accuracy of true relative positioning (Soper ¶[0073]).
Regarding claim 75, Gregerson as modified teaches the method of claim 74.
Soper further teaches further comprising:
determining a current pose of the imaging arm, based on the pose data (¶[0050]);
identifying a projection image that was acquired at the same pose or a similar pose as the current pose (¶[0088]); and
determining a location of the target structure in the second image data, based on the identified projection image (¶[0086]).
Regarding claim 76, Gregerson as modified teaches the method of claim 75.
Soper further teaches wherein the location of the target structure in the second image data corresponds to a location of the target structure in the identified projection image (¶[0086], ¶[0088]).
Conclusion
The prior art made of record and not relied upon is considered remaining pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2018/0049622 to Ryan et al. teaches mixed reality user interface from imaging data acquired by C-arm.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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