DETAILED ACTION
This Office action is responsive to communications filed on 05/08/2026. Claims 1, 4-8, 13, & 17 have been amended. Claims 2, 11 and 14 are canceled. Claim 20 is withdrawn. Presently, Claims 1, 3-10, 12-13, and 15-20 remain pending and are hereinafter examined on the merits.
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
Previous claim objections are withdrawn in view of the amendments filed on 05/08/2026.
Previous rejections under 35 USC § 101 are withdrawn in view of the amendments filed on 05/08/2026.
The Applicant’s arguments with respect to rejections under 35 USC § 103 have been fully, considered, but are not persuasive.
The Applicants characterization of Yang’s determination of the principle axis as not constituting a measurement and focuses on the updated locations of the vertebra, axis, and spinal cord in isolation is not persuasive. The rejection does not “merely” rely on determining an updated location or principle axis. Yang was relied upon for measuring and calculating anatomical parameters associated with the vertebra, which includes dimensions and orientation defining the cone of acceptance and principle axis, and comparing the resulting measurements with surgical plan criteria, including target coordinates, accepted angles and depths. Yang further determines the proximity of the tracked surgical instrument to the planned target. See the rejection as highlighted below. These disclosures teach the measuring an anatomical parameter in the updated digital model and comparing that parameter with a target anatomical parameter reflecting a successful and safe performance of the surgical procedure.
Applicant’s assertion that Yang does not update a surgical plan is incorrect. Yang updates the registered model and recalculates the principal axis and planned trajectory so that the surgical instrument remains directed toward the intended site. Its essential to Yang for the update to occur. The recalculated trajectory constitutes an updated surgical task that brings the measured condition into conformity with the target surgical parameters.
Applicant reliance on the claim requiring a numerical measurement is not commensurate with the scope of the claim. There is no numerical value, or score required. Moctezuma de la Barrera was relied upon to teach the use of ultrasound to obtain an intraoperative image data, not to remedy the limitations as discussed above. Applicant’s arguments regarding Moctezuma de la Barrera for limitations for which the reference was not relied upon are not persuasive.
The 35 USC § 103 rejection is maintained.
Claim Objections
The following claims are objected to because of the following informalities and should recite:
Claim 7: “The segmental tracking method of claim [[5]]6,”.
Appropriate correction is required.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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.
Claims 1, 3-4, 6-10, 12-13, 15-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al (US 2013/0060146 A1) in view of Moctezuma de la Barrera et al (US20190069882A1).
Claim 1: Yang discloses, A segmental tracking method, comprising:
-Yang teaches a method of segmental tracking achieved by processing pre-operative image data to define individual segments and subsequently registering intraoperative image data to these segments to define their updated position and orientation during surgery, ¶0101, ¶0115-0116, ¶0118-0119, ¶0121-0124, ¶0132-0133, ¶0150-0154,
receiving first image data captured at a first time and comprising a first bony anatomical object and a second bony anatomical object anatomically connected to the first bony anatomical object, the first image data being captured using a first imaging modality;
-Yang teaches that the system utilizes pre-operative image data (i.e., captured at a first time) associated with a patient stored on a storage medium, ¶0010, ¶0012, ¶0100, ¶0103, using a first imaging modality, such as CT or MRI, ¶Abstract, ¶0116. The pre-operative image data (i.e., CT image data) captures an anatomical region of interest such as the entire spine. This data is a 3D image dataset, ¶0115-0116, and is segmented into a rigid structure segments that have rotational and translational degrees of freedom with respect to another, ¶0118-0119. Specifically, Yang discloses, the first image data at a first time, by obtaining the 3D image dataset preoperatively to locate an anatomical region of interest. This data constitutes as preoperative image data associated with a patient.
-Yang highlights on the fact that the focus of the disclosure is on the spine, which is segmented into individual vertebrae. The CT scan of the patient’s spine, ¶0117 is processed and segmented into individual vertebrae, ¶0119, ¶0140-0141. The output includes a given number, N, of preoperative surface image data segments, (CT_MESH_OB_1 . . . CT_MESH_OB_N) (where N is the number of elements segmented from the structure and in this example, the number of vertebrae), ¶0119, ¶0153. Thus, the presence of a first and second bony anatomical object are anatomically connected (i.e., as in a spinal column). Thus, the first and second bony anatomical objects are represented (e.g., vertebra 1 and vertebra 2).
-The preoperative image data is acquired using modalities such as CT, MRI, PET or ultrasound imaging techniques, ¶0009, ¶0099-0100, ¶0115-0116, ¶0117, (i.e., preferably CT - a first imaging modality).
receiving second image data captured at a second time and comprising at least the first bony anatomical object, the second image data comprising tomographic or topographic image data of the first bony anatomical object captured using a second imaging modality;
-Yang discloses the system utilized inter-operative data (i.e., captured at a second time) associated with the patient. The topological data (surface image data) is obtained intraoperatively, ¶0009-0010, ¶0102, ¶0114. This data can be captured continuously or on demand during the procedure, ¶0122-0123, ¶0185-0186. The intraoperative data is obtained by optically scanning the exposed surface of the patient, ¶0010-0012, ¶0122-0123. The surface belongs to a rigid structure of interest, such as the vertebra, ¶0075, ¶0090, ¶0107, which correspond to one of the anatomical objects defined in the pre-operative plan, ¶0102, ¶0113, ¶0121-0123. The second image data is backscattered radiation surface topology data obtained using devices that employ techniques such as structured light illumination, laser triangulation, etc, ¶0071, ¶0090-0091, ¶0095, ¶0113, ¶0121-0123. The second image data is captured using a second imaging modality, such as a surface topology imaging device (e.g., structured light or laser range scanning), ¶0107, ¶0139. This interoperative scan captures the exposed bony object (e.g., the targeted vertebra), ¶0107, ¶0139. The system of Yang, then registers the individual segments from the first dataset to the topological data from the second dataset to track the position and orientation of the anatomy, ¶0123, ¶0151.
correlating a representation of the first bony anatomical object in the tomographic or topographic image data to a representation of the first and second bony anatomical objects in the first image data;
-Yang’s system core function is to correlate or register the intra-operative data to the pre-operative data. This process is referred to as registration, which aligns the datasets from different coordinates and/or different techniques, ¶0010-0012, ¶0062, ¶0131. Specifically, the intraoperative backscatter radiation topology data (second image data), which represents the exposed surgical structure (the first anatomical object), ¶0121-0123, is registered to the segmented preoperative image data (first image data), ¶0121-0123.
updating a digital model of the first and second bony anatomical objects based on the correlation to reflect movement of the first bony anatomical object relative to the second bony anatomical object that occurred between the first time and the second time;
-Yang teaches updating a digital model to reflect relative movement between anatomical objects and subsequently updating a surgical plan based on this update model. Yang teaches the spine is segmented into the rigid structure segments that have rotational and translation degree of freedom with respect to each other (e.g., individual vertebrae), This means the segments are treated as moveable relative to each other within the overall digital model derived from the pre-operative image data, ¶0118-0119. During surgery, the position of a vertebrae (first anatomical object) can shift due to surgical intervention (e.g., pressure applied to the vertebrae) or movement of the subject, causes its position to be displaced from the operatively determined position, ¶0108, ¶0140.
-The surgical guidance controller registers the intraoperative topological image data, which captured the exposed surface of the moving structure to the segmented pre-operative image data, ¶0010-0012, ¶0075, ¶0150-0151. This registration generates a transformation matrix (including translation and rotation identities, such as roll, pitch, and yaw) for each of the segmented structures, ¶0132-0133, ¶0154. These derived transformation matrices are then applied to the combined segmented structures to update and to match the structures to the current intraoperative geometry, ¶0132-0133, ¶0154. This process effectively updates the digital model of the structure (e.g., vertebrae 23) from its preoperative position to its intraoperative position, ¶0109, ¶0140. The mechanism of this registration is performed individually on segments reflected movement, and is an example of motion correction, ¶0105-0106, ¶0132-0134.
measuring an anatomical parameter in the updated digital model, the measured anatomical parameter being associated with the first bony anatomical object, the second bony anatomical object, or both; (¶0104-0106, the measurement and calculation of the specifical anatomical parameters in the digital model is relative to the anatomy such as the cone of acceptance. This parameter defines a frustrum conical shape of available trajectories for a surgical device based on the specific dimensions and orientation of the vertebra, and tracks the principle axis that is central though the narrowest section of the pedicle canal.)
comparing the measured anatomical parameter to a target anatomical parameter that reflects a degree of success for a surgical procedure; (¶0104-0106, ¶0111-0112, the comparison of the measured locations against the surgical criteria established in the surgical plan, such as the target coordinates of the entry point, accepted angles and acceptable depths of the screw placement. These are target parameters set to define an optimal implementation site for safe surgery, ensuring the procedure avoids damaging the spinal cord. The system calculates and outputs distance measurements indicating the proximity of the tracked surgical tool to this defined target in the surgical plan, ¶0072.)
updating, based on the comparison, a surgical plan for the surgical procedure to include one or more surgical tasks for bringing the measured anatomical parameter closer to the target anatomical parameter; (¶0109, ¶0103, ¶0108-0109, ¶0154-0155, The system detects when surgical structures shift it dynamically updates the preoperative surgical plan to match the intraoperative geometry. When a vertebra is displaced, the system recalculates the principle axis to an updated principle axis position thereby updating the planned trajectory (i.e., the task) to safely guide the interventional device to the ideal insertion site based on the updated coordinates).
generating navigation guidance to control a robot to execute the one or more surgical tasks in the updated surgical plan; and controlling the robot to execute the one or more surgical tasks in the updated surgical plan based on the navigation guidance. (¶0027, ‘it is recognized that such guidance feedback can also be provided to, and utilized by, other persons or systems, such as autonomous or semi-autonomous surgical robotic systems for the automated guidance of such surgical robotic systems. Furthermore, although many of the preceding examples include the co-registration of a surgical plan, it is to be understood that embodiments may be practiced without the incorporation of a surgical plan.’, see also ¶0229-0230 in the alternative embodiments the system tracks a robotic arm to allow the precise placement or manipulation of objects via the tacked robotic arm.).
Therefore, it would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the control of the robot of Yang such that it is controlled to execute the one or more surgical tasks in the updated surgical plan based on the navigation guidance as further taught by Yang alternative embodiment for the advantage of providing and improve system and method such that “this would allow precise placement of components onto the base structure via the robotic arm.”, ¶0229 as suggested by Yang.
Yang fails to disclose that the second imaging modality used is an ultrasound imaging device.
However, Moctezuma de la Barrera in the context of ultrasound bone registration with co-modality imaging of the object (bony anatomical object), discloses, that the second imaging modality used is an ultrasound imaging device (¶0033, ‘the ultrasound device 21 may be moved to a position adjacent to and in contact with the patient such that the ultrasound device 21 detects the femur F or the tibia T of the patient. A sweep of the femur F or the tibia T may be performed.’)
- Moctezuma de la Barrera specifically teaches that the method and system utilizes this data to register intraoperative ultrasound imaging (second data) to the pre-operative co-modality imaging (i.e., CT), ¶0029. Ultrasound imaging is specifically used to detect the surface of the object (i.e., bone surface). The system process the ultrasound to reconstruct larger are of the bone surface and extracts a point cloud of the object surface, ¶Abstract, ¶0009, ¶0042. This is indicative of surface data (topographic). The ultrasound imaging is generated by propagating waves along scanlines to generate frames. This workflow involves analyzing these frames (i.e., first and second steered frames) to segment the anatomy. This is indicative of tomographic (i.e., slice/frame) data, ¶0030, ¶0036.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the second imaging modality of modified Yang such that it utilizes ultrasound imaging as taught by Moctezuma de la Barrera. The motivation to do this yields predictable results such as improving workflow to register ultrasound imaging to a co-modality imaging that overcomes the disadvantageous of insufficient detection coverage of the visible bone surface, or the occurrence of false positive detections, as suggested by Moctezuma de la Barrera, ¶0002-0003.
Claim 3: Modified Yang discloses all the elements above in claim 1, Yang discloses, wherein updating the surgical plan comprises changing a predetermined tool trajectory based on the updated digital model. (¶0103, ‘During surgery, the preoperative plan is updated to reflect the intraoperative geometry of a patient's spine with the optimal trajectory and a cone of acceptance, described below, as a guide to assist a surgeon during pedicle screw insertion.’; ¶0104, ‘The cone of acceptance 25 is defined by a range of trajectories relative to the vertebrae 23, along which the pedicle screw can be securely implanted into the pedicle canal without damaging the spinal cord 24, sparing the surrounding peripheral nerves and blood vessels, and does not protrude out of the bone. The range of available trajectories has limited lateral and angular freedom in light of the narrow middle section of the pedicle canal. Taken together, the trajectories collectively define a frustum conical shape with a wider end at an entry surface of the vertebral arch.’; ¶0105, ‘The range 28 of available trajectories relative to a vertebra 23 is dependent on: (1) the dimensions of the vertebra; (2) the orientation of the vertebra 23; and (3) the size of the pedicle screw. The cone of acceptance 25 incorporates the narrowest section of the pedicle canal, along a principle axis 26, for defining the optimal surgical implantation site for safe and secure pedicle screw insertion.’; ¶0109, ‘Referring now to FIG. 7, an example shift in the position of the vertebra 23 from a preoperative position 23 to an intraoperative position 23′ is illustrated. The vertebrae 23 preoperative position is used to develop the surgical plan. In developing the surgical plan, the principle axis 26 is determined to ensure avoidance of the spinal cord 24. The preoperative positions of the structures are indicated with solid lines. During surgery, positions can shift due to, for example, surgical intervention and change in subject position, as noted above. The updated locations of the target vertebrae 23′, principle axis 26′, and spinal cord 24′ are determined by the system 100 and outputted on the display 4. Accordingly, system 100 provides a dynamically updated surgical plan that is registered to the patient anatomy in real-time.’)
Claim 4: Modified Yang discloses all the elements above in claim 1, wherein the anatomical parameter comprises an anatomical angle. (“angle of the pedicle canal relative to the surgically exposed surface of the vertebrae”- ¶0073, ¶0104-0105, ¶0111-0112)
Claim 6: Modified Yang discloses all the elements above in claim 1, Yang discloses, wherein the(¶0072, ¶0103-0105, ¶0111-0112)
Claim 7: Modified Yang discloses all the elements above in claim 5, Yang discloses, wherein updating the surgical plan comprises updating the surgical plan based on the measured anatomical parameter of interest. (¶0072, ¶0103-0106, ¶0108-0109 ¶0111-0112)
Claim 8: Modified Yang discloses all the elements above in claim 7, Yang discloses, wherein the updated surgical plan comprises at least one surgical task associated with the measured anatomical parameter of interest. (¶0100, ¶0103-0106, ¶0108-0109, ¶0117, ¶0155)
Claim 9: Modified Yang discloses all the elements above in claim 1, Yang discloses, wherein the second image data comprises a data stream of the tomographic or topographic image data, and the correlating and the updating the digital model occur in real-time or near real-time. (¶0109, ‘During surgery, positions can shift due to, for example, surgical intervention and change in subject position, as noted above. The updated locations of the target vertebrae 23′, principle axis 26′, and spinal cord 24′ are determined by the system 100 and outputted on the display 4. Accordingly, system 100 provides a dynamically updated surgical plan that is registered to the patient anatomy in real-time.’, see also ¶Abstract, ¶0010-0011, ¶0090, ¶0100, ¶0114 – regarding the topological image data and surface topology image data that is consistently described with respect to the second image data.)
Claim 10: Modified Yang discloses all the elements above in claim 1, Yang discloses, further comprising displaying the updated digital model on a user interface. (FIG. 6a-6b; ¶0108, ‘An updated position of the vertebra 23′ can be determined and outputted by the system 100 on the display 4.’; ¶0110, ‘Intraoperative image updates of the vertebrae 23 can be provided continuously or discretely according to input into the system 100 by, for example, a surgeon. In the situation where updates are provided continuously, the system 100 can operate autonomously obviating the need for the surgeon to input any additional data. In the situation where updates are provided discretely, for example updates provided at single time points, the surgeon can request an image data update by inputting a request into the system 100. The updated plan is provided on the display device 4 on command without any other user interface. The updated image data and related updated intraoperative surgical plan enable a surgeon to accurately implant, for example, a pedicle screw into a vertebra 23.’; ¶0111, ‘the surgical plan may include surgical criteria that can be displayed on the co-registered image. Examples of criteria that the surgeon may input into system 100, as part of a surgical plan, include, but are not limited to: the accepted accuracy of screw placement; the coordinates of the point of entry into the vertebra 23 that define the principle axis 26; the accepted angle of screw placement; and the depth of screw placement.’
Claim 12: Modified Yang discloses all the elements above in claim 1, Yang discloses, wherein correlating the representation of the first bony anatomical object in the second image data to the representation of the first and second bony anatomical objects in the first image data is performed without fiducial markers being on the first and second bony anatomical object.
(¶Abstract, ‘three-dimensional image data associated with an object or patient is registered to topological image data obtained using a surface topology imaging device.’; ¶0114, ‘Intraoperative topology imaging data is then acquired in step 51 and registered to the pre-operative image data for providing guidance feedback to guide the surgical procedure intraoperatively.’)
See also ¶0087, ¶0108, ¶0113, ¶0124-0125 – regarding fiducial free guidance of the system of Yang. In that it is the advantage of the present system that fiducial marks are not required for surgical guidance, “it is an advantage of the present system that fiducial markers are not required for surgical guidance.”=¶0087.
Claim 13: A segmental tracking system, comprising:
-Yang teaches a method of segmental tracking achieved by processing pre-operative image data to define individual segments and subsequently registering intraoperative image data to these segments to define their updated position and orientation during surgery, ¶0101, ¶0115-0116, ¶0118-0119, ¶0121-0124, ¶0132-0133, ¶0150-0154,
a communication interface; (workstation 7; ¶0085, ‘User workstation 7 may consist of display 4, such as a high definition monitor, the surgical guidance controller 3, and user interface 5, such as a keyboard, for inputting instructions into the system 100’) (¶0099, ‘Image dataset provided to system 100 can include any of the following non-limiting examples: preoperative 3D image data of a surgical structure of interest, such as the spine, in a subject acquired, for example, using any one of PET, CT, MRI, or ultrasound imaging techniques; a preoperative surgical plan developed by a clinical practitioner (for example, a surgeon), and a surface topology image dataset, optionally including texture data, of the rigid surgical structure of interest.’)
an second imaging device; (¶0009, ‘The surface topology imaging device may be rigidly attached to an optical position measurement system’; ¶0114, ‘Intraoperative topology imaging data is then acquired in step 51 and registered to the pre-operative image data for providing guidance feedback to guide the surgical procedure intraoperatively.’)
at least one processor; and (surgical guidance controller 3)
a memory storing instructions for execution by the at least one processor that, when executed, cause the at least one processor to: (¶0085, ‘memory storage device 2 to carry out the methods described herein’; ¶0074, ‘Surgical guidance controller 3 can be, for example, a processing unit and associated memory containing one or more computer programs to control the operation of the system, the processing unit in communication with a user interface unit 5 and the display 4. In one example, surgical guidance controller 3 may be a computing system such as a personal computer or other computing device, for example in the form of a computer workstation, incorporating a hardware processor and memory, where computations are performed by the processor in accordance with computer programs stored in the memory to carry out the methods described herein. For example, the processor can be a central processing unit or a combination of a central processing unit and a graphical processing unit’)
receive, via the communication interface, first image data captured at a first time and comprising a first bony anatomical object and a second bony anatomical object anatomically connected to the first bony anatomical object, the first image data being captured using a first imaging modality different than the second image imaging device;
-Yang teaches that the system utilizes pre-operative image data (i.e., captured at a first time) associated with a patient stored on a storage medium, ¶0010, ¶0012, ¶0100, ¶0103, using a first imaging modality, such as CT or MRI, ¶Abstract, ¶0116. The pre-operative image data (i.e., CT image data) captures an anatomical region of interest such as the entire spine. This data is a 3D image dataset, ¶0115-0116, and is segmented into a rigid structure segments that have rotational and translational degrees of freedom with respect to another, ¶0118-0119. Specifically, Yang discloses, the first image data at a first time, by obtaining the 3D image dataset preoperatively to locate an anatomical region of interest. This data constitutes as preoperative image data associated with a patient.
-Yang highlights on the fact that the focus of the disclosure is on the spine, which is segmented into individual vertebrae. The CT scan of the patient’s spine, ¶0117 is processed and segmented into individual vertebrae, ¶0119, ¶0140-0141. The output includes a given number, N, of preoperative surface image data segments, (CT_MESH_OB_1 . . . CT_MESH_OB_N) (where N is the number of elements segmented from the structure and in this example, the number of vertebrae), ¶0119, ¶0153. Thus, the presence of a first and second bony anatomical object are anatomically connected (i.e., as in a spinal column). Thus, the first and second bony anatomical objects are represented (e.g., vertebra 1 and vertebra 2).
-The preoperative image data is acquired using modalities such as CT, MRI, PET or ultrasound imaging techniques, ¶0009, ¶0099-0100, ¶0115-0116, ¶0117, (i.e., preferably CT - a first imaging modality).
obtain, using the second imaging device, second image data at a second time that comprises at least the first bony anatomical object, the second image data comprising tomographic or topographic image data of the first bony anatomical object;
-Yang discloses the system utilized inter-operative data (i.e., captured at a second time) associated with the patient. The topological data (surface image data) is obtained intraoperatively, ¶0009-0010, ¶0102, ¶0114. This data can be captured continuously or on demand during the procedure, ¶0122-0123, ¶0185-0186. The intraoperative data is obtained by optically scanning the exposed surface of the patient, ¶0010-0012, ¶0122-0123. The surface belongs to a rigid structure of interest, such as the vertebra, ¶0075, ¶0090, ¶0107, which correspond to one of the anatomical objects defined in the pre-operative plan, ¶0102, ¶0113, ¶0121-0123. The second image data is backscattered radiation surface topology data obtained using devices that employ techniques such as structured light illumination, laser triangulation, etc, ¶0071, ¶0090-0091, ¶0095, ¶0113, ¶0121-0123. The second image data is captured using a second imaging modality, such as a surface topology imaging device (e.g., structured light or laser range scanning), ¶0107, ¶0139. This interoperative scan captures the exposed bony object (e.g., the targeted vertebra), ¶0107, ¶0139. The system of Yang, then registers the individual segments from the first dataset to the topological data from the second dataset to track the position and orientation of the anatomy, ¶0123, ¶0151.
correlate a representation of the first bony anatomical object in the tomographic or topographic image data to a representation of the first and second bony anatomical objects in the first image data;
-Yang’s system core function is to correlate or register the intra-operative data to the pre-operative data. This process is referred to as registration, which aligns the datasets from different coordinates and/or different techniques, ¶0010-0012, ¶0062, ¶0131. Specifically, the intraoperative backscatter radiation topology data (second image data), which represents the exposed surgical structure (the first anatomical object), ¶0121-0123, is registered to the segmented preoperative image data (first image data), ¶0121-0123.
update a digital model of the first and second bony anatomical objects based on the correlation to reflect movement of the first bony anatomical object relative to the second bony anatomical object that occurred between the first time and the second time;
-Yang teaches updating a digital model to reflect relative movement between anatomical objects and subsequently updating a surgical plan based on this update model. Yang teaches the spine is segmented into the rigid structure segments that have rotational and translation degree of freedom with respect to each other (e.g., individual vertebrae), This means the segments are treated as moveable relative to each other within the overall digital model derived from the pre-operative image data, ¶0118-0119. During surgery, the position of a vertebrae (first anatomical object) can shift due to surgical intervention (e.g., pressure applied to the vertebrae) or movement of the subject, causes its position to be displaced from the operatively determined position, ¶0108, ¶0140.
-The surgical guidance controller registers the intraoperative topological image data, which captured the exposed surface of the moving structure to the segmented pre-operative image data, ¶0010-0012, ¶0075, ¶0150-0151. This registration generates a transformation matrix (including translation and rotation identities, such as roll, pitch, and yaw) for each of the segmented structures, ¶0132-0133, ¶0154. These derived transformation matrices are then applied to the combined segmented structures to update and to match the structures to the current intraoperative geometry, ¶0132-0133, ¶0154. This process effectively updates the digital model of the structure (e.g., vertebrae 23) from its preoperative position to its intraoperative position, ¶0109, ¶0140. The mechanism of this registration is performed individually on segments reflected movement, and is an example of motion correction, ¶0105-0106, ¶0132-0134.
measure an anatomical parameter in the updated digital model, the measured anatomical parameter being associated with the first bony anatomical object, the second bony anatomical object, or both; (¶0104-0106, the measurement and calculation of the specifical anatomical parameters in the digital model is relative to the anatomy such as the cone of acceptance. This parameter defines a frustrum conical shape of available trajectories for a surgical device based on the specific dimensions and orientation of the vertebra, and tracks the principle axis that is central though the narrowest section of the pedicle canal.)
compare the measured anatomical parameter to a target anatomical parameter that reflects a degree of success for a surgical procedure; (¶0104-0106, ¶0111-0112, the comparison of the measured locations against the surgical criteria established in the surgical plan, such as the target coordinates of the entry point, accepted angles and acceptable depths of the screw placement. These are target parameters set to define an optimal implementation site for safe surgery, ensuring the procedure avoids damaging the spinal cord. The system calculates and outputs distance measurements indicating the proximity of the tracked surgical tool to this defined target in the surgical plan, ¶0072.)
update, based on the comparison, a surgical plan for the surgical procedure to include one or more surgical tasks for bringing the measured anatomical parameter closer to the target anatomical parameter; (¶0109, ¶0103, ¶0108-0109, ¶0154-0155, The system detects when surgical structures shift it dynamically updates the preoperative surgical plan to match the intraoperative geometry. When a vertebra is displaced, the system recalculates the principle axis to an updated principle axis position thereby updating the planned trajectory (i.e., the task) to safely guide the interventional device to the ideal insertion site based on the updated coordinates).
generate navigation guidance that controls a robot to execute the one or more surgical tasks in the updated surgical plan; and control the robot to execute the one or more surgical tasks in the updated surgical plan based on the navigation guidance. (¶0027, ‘it is recognized that such guidance feedback can also be provided to, and utilized by, other persons or systems, such as autonomous or semi-autonomous surgical robotic systems for the automated guidance of such surgical robotic systems. Furthermore, although many of the preceding examples include the co-registration of a surgical plan, it is to be understood that embodiments may be practiced without the incorporation of a surgical plan.’, see also ¶0229-0230 in the alternative embodiments the system tracks a robotic arm to allow the precise placement or manipulation of objects via the tacked robotic arm.).
Therefore, it would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the control of the robot of Yang such that it is controlled to execute the one or more surgical tasks in the updated surgical plan based on the navigation guidance as further taught by Yang alternative embodiment for the advantage of providing and improve system and method such that “this would allow precise placement of components onto the base structure via the robotic arm.”, ¶0229 as suggested by Yang.
Yang fails to disclose that the second image device, is an ultrasound imaging device.
However, Moctezuma de la Barrera in the context of ultrasound bone registration with co-modality imaging of the object (bony anatomical object), discloses, that the second imaging modality used is an ultrasound imaging device (¶0033, ‘the ultrasound device 21 may be moved to a position adjacent to and in contact with the patient such that the ultrasound device 21 detects the femur F or the tibia T of the patient. A sweep of the femur F or the tibia T may be performed.’)
- Moctezuma de la Barrera specifically teaches that the method and system utilizes this data to register intraoperative ultrasound imaging (second data) to the pre-operative co-modality imaging (i.e., CT), ¶0029. Ultrasound imaging is specifically used to detect the surface of the object (i.e., bone surface). The system process the ultrasound to reconstruct larger are of the bone surface and extracts a point cloud of the object surface, ¶Abstract, ¶0009, ¶0042. This is indicative of surface data (topographic). The ultrasound imaging is generated by propagating waves along scanlines to generate frames. This workflow involves analyzing these frames (i.e., first and second steered frames) to segment the anatomy. This is indicative of tomographic (i.e., slice/frame) data, ¶0030, ¶0036.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the second imaging modality of Yang such that it utilizes an ultrasound imaging device as taught by Moctezuma de la Barrera. The motivation to do this yields predictable results such as improving workflow to register ultrasound imaging to a co-modality imaging that overcomes the disadvantageous of insufficient detection coverage of the visible bone surface, or the occurrence of false positive detections, as suggested by Moctezuma de la Barrera, ¶0002-0003.
Claim 15: Modified Yang discloses all the elements above in claim 13, Yang discloses, wherein the second image data comprises a data stream of the tomographic or topographic image data, the correlating occurs continuously during receipt of the data stream, and the updating the digital model occurs continuously during the correlating. (¶0102, ‘An example implementation of surgical guidance through the use of backscattered radiation topology imaging can include, for example, acquiring preoperative imaging data and developing a surgical plan, performing intraoperative imaging, and, in combination with the preoperative image data, generating useful information to guide surgery in the form of co-registered images, and displaying or otherwise communicating this surgical guidance information to a surgeon or operator. A preoperative plan can be developed, for example, by a clinician using the preoperative image data, and made available for use in the system. This example implementation enables repetition of intraoperative imaging and generating guidance feedback.’; ¶0103, ‘During surgery, the preoperative plan is updated to reflect the intraoperative geometry of a patient's spine with the optimal trajectory and a cone of acceptance, described below, as a guide to assist a surgeon during pedicle screw insertion.’; ¶0109, ‘During surgery, positions can shift due to, for example, surgical intervention and change in subject position, as noted above. The updated locations of the target vertebrae 23′, principle axis 26′, and spinal cord 24′ are determined by the system 100 and outputted on the display 4. Accordingly, system 100 provides a dynamically updated surgical plan that is registered to the patient anatomy in real-time.’; ¶0110, ‘Intraoperative image updates of the vertebrae 23 can be provided continuously or discretely according to input into the system 100 by, for example, a surgeon. In the situation where updates are provided continuously, the system 100 can operate autonomously obviating the need for the surgeon to input any additional data. In the situation where updates are provided discretely, for example updates provided at single time points, the surgeon can request an image data update by inputting a request into the system 100. The updated plan is provided on the display device 4 on command without any other user interface. The updated image data and related updated intraoperative surgical plan enable a surgeon to accurately implant, for example, a pedicle screw into a vertebra 23.’; ¶0185, ‘Continuous updating of surgical guidance feedback may occur autonomously, such that upon completion of one update, another update automatically commences. In such an embodiment, the user is not required to manually input a request for an update from the system 100. Accordingly, the use of system 100 may be advantageous in reducing surgical procedure time, due to real time updates of the surgical structure of interest,’)
see also ¶Abstract, ¶0010-0011, ¶0090, ¶0100, ¶0114 – regarding the topological image data and surface topology image data that is consistently described with respect to the second image data.)
Claim 16: Modified Yang discloses all the elements above in claim 13, Yang discloses: further comprising a user interface (display 4), and wherein the memory stores additional instructions for execution by the at least one processor that, when executed further cause the at least one processor to: display the updated digital model on the user interface. (FIG. 6a-6b; ¶0108, ‘An updated position of the vertebra 23′ can be determined and outputted by the system 100 on the display 4.’; ¶0110, ‘Intraoperative image updates of the vertebrae 23 can be provided continuously or discretely according to input into the system 100 by, for example, a surgeon. In the situation where updates are provided continuously, the system 100 can operate autonomously obviating the need for the surgeon to input any additional data. In the situation where updates are provided discretely, for example updates provided at single time points, the surgeon can request an image data update by inputting a request into the system 100. The updated plan is provided on the display device 4 on command without any other user interface. The updated image data and related updated intraoperative surgical plan enable a surgeon to accurately implant, for example, a pedicle screw into a vertebra 23.’; ¶0111, ‘the surgical plan may include surgical criteria that can be displayed on the co-registered image. Examples of criteria that the surgeon may input into system 100, as part of a surgical plan, include, but are not limited to: the accepted accuracy of screw placement; the coordinates of the point of entry into the vertebra 23 that define the principle axis 26; the accepted angle of screw placement; and the depth of screw placement.’
Claim 18: Modified Yang discloses all the elements above in claim 13, Yang discloses: wherein the first and second bony anatomical objects correspond to first and second vertebrae. (FIG. 3a-3c, ¶0101, ‘the structure can be a bone structure, such as a spinal column, a skull, a hip bone, a foot bone, and a patella. For example, FIG. 3( b) is a schematic of a posterior orientation of a segmented spine; FIG. 3( c) is a schematic of a lateral orientation of the segmented spine’)
-Yang teaches that the system utilizes pre-operative image data (i.e., captured at a first time) associated with a patient stored on a storage medium, ¶0010, ¶0012, ¶0100, ¶0103. The pre-operative image data (i.e., CT image data) captures an anatomical region of interest such as the entire spine. This data is a 3D image dataset, ¶0115-0116, and is segmented into a rigid structure segments that have rotational and translational degrees of freedom with respect to another, ¶0118-0119. The CT scan of the patient’s spine, ¶0117 is processed and segmented into individual vertebrae, ¶0119, ¶0140-0141. The output includes a given number, N, of preoperative surface image data segments, (CT_MESH_OB_1 . . . CT_MESH_OB_N) (where N is the number of elements segmented from the structure and in this example, the number of vertebrae), ¶0119, ¶0153. Thus, the first and second anatomical objects are represented (e.g., vertebra 1 and vertebra 2).
Claim 19: Modified Yang discloses all the elements above in claim 13, Yang discloses: wherein correlating the representation of the first bony anatomical object in the tomographic or topographic image data to the representation of the first and second bony anatomical objects in the first image data is performed without fiducial markers being on the first and second bony anatomical objects (¶Abstract, ‘three-dimensional image data associated with an object or patient is registered to topological image data obtained using a surface topology imaging device.’; ¶0114, ‘Intraoperative topology imaging data is then acquired in step 51 and registered to the pre-operative image data for providing guidance feedback to guide the surgical procedure intraoperatively.’)
See also ¶0087, ¶0108, ¶0113, ¶0124-0125 – regarding fiducial free guidance of the system of Yang. In that it is the advantage of the present system that fiducial marks are not required for surgical guidance, “it is an advantage of the present system that fiducial markers are not required for surgical guidance.”=¶0087.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Yang et al (US 2013/0060146 A1) in view of Moctezuma de la Barrera et al (US 20190069882 A1), as applied to claim 4, in further view of Matsumoto et al (US 2020/0069243 A1).
Claim 5: Modified Yang discloses all the elements above in claim 4, Yang fails to disclose: wherein the anatomical angle is a Cobb angle.
However, Matsumoto et al in the context of spinal-column arrangement estimation discloses, wherein the anatomical angle is a Cobb angle. (¶0008-0009, ¶0077)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the anatomical angle of modified Yang such that it is a Cobb angle as taught by Matsumoto. The motivation to do this yields predictable results such as enabling a doctor to accurately diagnose the presence or absence and degree of scoliosis with reference to the Cobb angle, and variation in diagnosis amount doctors may be reduced, ¶0127 of Matsumoto.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Yang et al (US 2013/0060146 A1) in view of Moctezuma de la Barrera et al (US 20190069882 A1), as applied to claim 13, in further view of Kim (US20210398279A1) in view of Matsumoto et al (US 20200069243 A1).
Claim 17: Modified Yang discloses all the elements above in claim 13, Yang discloses: wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: (¶0085, ‘memory storage device 2 to carry out the methods described herein’; ¶0074, ‘Surgical guidance controller 3 can be, for example, a processing unit and associated memory containing one or more computer programs to control the operation of the system, the processing unit in communication with a user interface unit 5 and the display 4. In one example, surgical guidance controller 3 may be a computing system such as a personal computer or other computing device, for example in the form of a computer workstation, incorporating a hardware processor and memory, where computations are performed by the processor in accordance with computer programs stored in the memory to carry out the methods described herein. For example, the processor can be a central processing unit or a combination of a central processing unit and a graphical processing unit’)
Yang fails to disclose:
wherein the anatomical parameter comprises an anatomical angle between the first bony anatomical object and the second bony anatomical object based on the updated digital model, and
calculate the anatomical angle between the first bony anatomical object and the second bony anatomical object based on the updated digital model; and
However, Kim in the context of analyzing medical images of the vertebrae discloses:
wherein the anatomical parameter comprises an anatomical angle between the first bony anatomical object and the second bony anatomical object based on the updated digital model, and (¶Abstract, ¶0017-0022, ¶0095-0098, ¶0116-0117, ¶0120-0121)
calculate the anatomical angle between the first bony anatomical object and the second bony anatomical object based on the updated digital model; and (¶Abstract, ¶0017-0022, ¶0095-0098, ¶0116-0117, ¶0120-0121)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the anatomical parameter of modified Yang to comprise comprises an anatomical angle between the first bony anatomical object and the second bony anatomical object based on the updated digital model, and calculate the anatomical angle between the first bony anatomical object and the second bony anatomical object based on the updated digital model and display the calculated anatomical angle on a user interface as taught by Kim. The motivation to do this yield predictable results such as providing more accurate 3D spinal disease diagnosis while avoiding high cost, radiation exposure, as suggested by Kim, ¶0003-0006.
Yang fails to disclose: display the calculated anatomical angle on a user interface.
However, Matsuomoto et al in the context of spinal-column arrangement estimation discloses,
display the calculated anatomical angle on a user interface. (¶0124, ‘In step S42, the SCAE unit 12 of the CPU 1 estimates spinal-column arrangement from the unknown 3D image acquired by the image acquisition unit 11 using learning data (accumulated data) after machine learning stored in the learning data memory 23. An estimation result of the spinal-column arrangement is stored in the estimation data memory 24.’; ¶0126, ‘In step S44, the image output control unit 14 of the CPU 1 reads the spinal-column arrangement estimated by the SCAE unit 12 and the Cobb angle calculated by the angle calculation unit 13 from the estimation data memory 24, and displays the read spinal-column arrangement and Cobb angle on, for example, a screen of a display corresponding to the output device 4.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processor of modified Yang such that it calculates an anatomical angle between the first bony anatomical object and the second bony anatomical object based on the updated digital model; and display the calculated anatomical angle on a user interface as taught by Matsumoto. The motivation to do this yields predictable results such as enabling a doctor to accurately diagnose the presence or absence and degree of scoliosis with reference to the Cobb angle, and variation in diagnosis amount doctors may be reduced, ¶0127 of Matsumoto.
Conclusion
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.
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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