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 Amendment
This communication is filed in response to the action filed on 06/22/2026.
Claims 16 and 33 are currently amended. Claims 16-35 are pending.
The examiner would like to note to the applicant that the claims were not properly amended and marked up according to the MPE section 714. However, the examiner was able to make sense of the amended claims despite lacking the proper markup and in the sake of compact prosecution examined the claims as filed however would like the applicant to note and apply proper MPEP amendment format with more information being available under section 714 of the MPEP for further prosecution on the claims.
Response to Arguments
Applicant’s arguments filed on 06/22/2026 on pages 7-9, under REMARKS with respect to 35 U.S.C. 102 and 35 U.S.C. 103 have been fully considered but they are not persuasive. Regarding claim 16 applicants on page 8 state that:
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The examiner respectfully disagrees. The examiner would like to point to a few specific sections of primary reference US 2023/0363832 A1 to MOSADEGH which clearly show an established spatial relationship in the virtual environment. These sections include paragraph [00009] which states “In certain aspects, various embodiments relate to a method of providing real-time image guidance and/or navigation for a medical procedure. The method may comprise: receiving a first image data set of an anatomical target in relation to at least one fiducial marker in a selected coordinate system; generating a 3D model of the anatomical target, in relation to the first image data set and the at least one fiducial marker, in the selected coordinate system; receiving at least one fluoroscopic image comprising the at least one fiducial marker and a medical device; generating a mask and/or a center coordinate of the at least one fiducial marker from the at least one fluoroscopic image; generating a 3D model of the medical device from the at least one fluoroscopic image in the selected coordinate system using a trained deep learning model to perform feature extraction of the medical device and the at least one fiducial marker and to determine a z-position of at least one portion of the medical device within the selected coordinate system; registering the 3D model of the medical device with the 3D model of the anatomical target in the selected coordinate system; and generating a real-time output image comprising the 3D model of the medical device registered with a geometry of the anatomical target in the selected coordinate system”, wherein the determined z position acts and clearly demonstrates a spatial relationship/position determined using the coordinate system of the virtual environment, MOSADEGH further cites spatial position relationships at fig 7; claims 1 and 28; and paragraphs [0035], [0051], [0098-0100] which discuss further determining the z-position. See full rejection to the claims below.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16-24, 27-29, and 32-35 are rejected under 35 § U.S.C. 102(a)(2) as being anticipated by US 2023/0363832 A1 to MOSADEGH et al. (hereinafter “MOSADEGH”).
As per claim 16, MOSADEGH discloses a method of image guided surgery (a computing system and corresponding method of virtual reality image guided surgical operations; abstract; figs 1, 4-5, and 12; paragraphs [0113-0117], [0123-0125]; claims 18), wherein the method is performed by a programmed processing unit, the method comprising (the computing system includes a virtual model generator module 112 which generates a model of an anatomical target 126 and further a model medical device to perform virtual guided surgical procedures or practice said procedures; abstract; figs 1, 4-5, and 12; paragraphs [0113-0117], [0123-0125]; claim 18): receiving a first model virtually representing an anatomical structure (the computing system includes a virtual model generator module 112 which generates a model of an anatomical target 126 and further a model medical device to perform virtual guided surgical procedures or practice said procedures; abstract; figs 1, 4-5, and 12; paragraphs [0113-0117], [0123-0125]; claims 18); receiving a second model virtually representing an object (the second virtual model is a virtual model of a surgical tool/medical device used in the simulated operation; abstract; figs 1, 4-5, and 12; paragraphs [0113-0117], [0123-0125]; claims 18); processing a projection image generated by an imaging device from an imaging direction, wherein the projection image includes at least a part of the anatomical structure and at least a part of the object (the computing system is adapted to create a virtual environment in which the virtual models of the anatomical target and the object which is a medical device/surgical tool are both projected into the virtual environment and interact with one another and provides haptic feedback to the user to simulate the actual process; abstract; figs 1, 4-5, and 12; paragraphs [0113-0117], [0123-0125]; claims 18); and determining a spatial position and orientation of the object relative to a space of movement (and the virtually generated anatomical model and the virtually generated surgical tool model is adapted for interaction and haptic feedback to the user when used on the anatomical model in the virtual space in order to perform simulated operations and provide model which are oriented in a virtual space and have spatial relationships to simulates the procedure, by receiving a first image data set of an anatomical target in relation to at least one fiducial marker in a selected coordinate system, and generating a 3D model of the anatomical target, in relation to the first image data set and the at least one fiducial marker, in the selected coordinate system; paragraphs [0009], [0075], [0106], [0113-0117], [0123-0125]; claims 1 and 18), wherein the space of movement is defined in relation to the anatomical structure, wherein the determination is based on a combination of (i) the projection image (a spatial position is determined in a standardized coordinate system which includes all virtual models generated by the model generator and all anatomical structures generated are centered about the spine which is used as a rigid object and has a relatively consistent position within the subject, the spine can be used as a universal fiducial marker in order to center the coordinate system and orient the medical device/surgical tool models wielded by the operator/user; figs 23A-23C, 24A-24C, 25A-25C; paragraphs [0088-0090], [0121], [0155-0160]; claims 1, 18, and 19),(ii) the imaging direction (the system is adapted to image the modeled anatomical structure at all arm angles in order to build a comprehensive 3D model which mimics anatomical motion such as moving into a diastole and systole cardiac positions; abstract; figs 1, 4-5, and 11-12; paragraphs [0075], [0106], [0113-0117], [0123-0125]; claims 18), (iii) the first model (the computing system is adapted to generate via the model generator generate a 3D model virtual representation of the anatomical targets of the patient being operated on; figs 1, 4-5, and 11-12; paragraphs [0075], [0106], [0113-0117], [0123-0125]; claim 18), and(iv) the second model (the computing system including the model generator is adapted to generate in the standard coordinate system in order to interact with the anatomical model using a medical device/surgical tool model acting as the object model; figs 1, 4-5, and 11-12; paragraphs [0075], [0106], [0113-0117], [0123-0125]; claim 18).
As per claim 17, MOSADEGH discloses the method of claim 16, further comprising: moving the object within the determined space of movement (wherein the motion of the medical device is reflected in the virtual environment comprising the virtual medical device model and the anatomical target model in a standardized coordinate system of said virtual environment for practicing surgical operation; paragraphs [0032-0035], [0112-0115], [0118-0123]); and monitoring a movement of the object within the determined space of movement (the computing system includes a display portion in order to monitor motion of the virtual models in the virtual environment; paragraphs [0032-0035], [0055]).
As per claim 18, MOSADEGH discloses the method of claim 16, wherein the object is attached to a robotic device (the virtual model is adapted to be connected to a robotic system in the real world wherein the robotic arm mimics the motion of the virtual model in a closed loop instructional manner; claim 27).
As per claim 19, MOSADEGH discloses the method of claim 18, further comprising: moving the object within the determined space of movement (output quantitative feedback of z-axis position of at least a portion of the medical device relative to the anatomical target or another anatomical feature as a closed-loop instruction to the robotic controller to cause the robot to move the end effector controlling the medical device to cause a related movement of the medical device; claim 27 and 53); and restricting a movement of the object to within the determined space of movement (the system controls the motion of the end effector of the robotic arm which controls the medical device and is restricted to closed loop control and most follow the directed motion of the robotic controller and emulate the movement within the defined virtual/corresponding real space and only the space; paragraphs [0032-0035], [0112-0115], [0118-0123]; claim 27 and 53).
As per claim 20, MOSADEGH discloses the method of claim 18, further comprising: moving the object within the determined space of movement (wherein the motion of the medical device is reflected in the virtual environment comprising the virtual medical device model and the anatomical target model in a standardized coordinate system of said virtual environment for practicing surgical operation; paragraphs [0032-0035], [0112-0115], [0118-0123]); and controlling a movement of the object within the determined space of movement (the virtual model is adapted to be connected to a robotic system in the real world wherein the robotic arm mimics the motion of the virtual model in a closed loop instructional manner; claim 27).
As per claim 21, MOSADEGH discloses the method of claim 18, wherein the robotic device comprises a sensor, wherein the determining of the spatial position and orientation of the object relative to the space of movement is further based on information received from the sensor (the computing system which controls a robotic arm wherein the robotic arm includes a sensor for imaging of various modalities which are synchronized with the system using direct image processing algorithms; fig 1; paragraphs [0105-0108], [0113], [0116]).
As per claim 22, MOSADEGH discloses the method of claim 16, wherein determining the spatial position and orientation of the object relative to the space of movement is further based on a real-time navigation system, wherein the real-time navigation system is selected from the group consisting of: a navigation system with optical trackers, a navigation system with infrared trackers, a navigation system with EM tracking, a navigation system utilizing a 2D camera, a navigation system utilizing Lidar, a navigation system utilizing a 3D camera, a navigation system including a wearable tracking element or a navigation system including augmented reality glasses (system 100 can include a guidance system 102 that receives image data from a first imaging device 104 and second imaging device 106 which are cameras and used in order to track objects related to the generated virtual models and provides the ability to image object position and orientation; paragraphs [0113-0117]).
As per claim 23, MOSADEGH discloses the method of claim 16, wherein the first model is selected from the group consisting of: a (statistical) deformable shape model, a surface model, an (statistical) deformable appearance model, a surface model of a CT Scan, a surface model of a MR scan, a surface model of PET scan, a surface model of an intraoperative 3D x-ray, or 3D image data, where 3D image data is one out of the group consisting of a CT scan, a PET Scan, a MR scan, an intraoperative 3D x-ray scan, or a combination thereof (the model generator 112 can receive the image data sets 134 from the first imaging device 104, the second imaging device 106, and/or the sensors 108 and includes CT image scans; paragraphs [0113-0117]).
As per claim 24, MOSADEGH discloses the method of claim 16, wherein the model is 3D image data, and the method further comprises determining the imaging direction of the projection image based on generating a plurality of virtual projection images each from different virtual imaging directions of the 3D image data and identifying the one virtual projection image out of the group of virtual projection images that has maximum similarity with the projection image (the model is made as a 3D image model with motion compensation for anatomical models which move such as the lung or heart, the models are generated using captured image data from image sensor 104, and 106 and the real world objects are imaged at all arm angles in order to generate accurate 3D models in the virtual environment; abstract; figs 1, 4-5, and 12; paragraphs [0113-0117], [0123-0125]; claims 18).
As per claim 27, MOSADEGH discloses the method of claim 16, wherein the determination of a spatial position and orientation of the object relative to the space of movement is further based on a priori information about a spatial relation between the object and the anatomical structure (the virtual models are adapted to include based on observed medical data motion compensation such that the anatomical target models will have motion simulating the cardiac cycle and respiration cycle such that the motion is included during virtual surgical operations; abstract; figs 1, 4-5, and 12; paragraphs [0113-0117], [0123-0125], [0145]; claims 18).
As per claim 28, MOSADEGH discloses the method of claim 27, wherein the a priori information about the spatial relation is selected from the group consisting of a point on the object and part of the anatomical structure or a point on an axis of the object, wherein the point is defined relative to the anatomical structure (the spine is used in order to define the standard coordinate system such that a spatial position is determined in a standardized coordinate system which includes all virtual models generated by the model generator and all anatomical structures generated are centered about the spine which is used as a rigid object and has a relatively consistent position within the subject, the spine can be used as a universal fiducial marker in order to center the coordinate system and orient the medical device/surgical tool models wielded by the operator/user; figs 23A-23C, 24A-24C, 25A-25C; paragraphs [0088-0090], [0121], [0155-0160]; claims 1, 18, and 19).
As per claim 29, MOSADEGH discloses a device for image guided surgery comprising (a computing system and corresponding method of virtual reality image guided surgical operations; abstract; figs 1, 4-5, and 12; paragraphs [0113-0117], [0123-0125]; claims 18): a processing unit configured to receive a first model virtually representing an anatomical structure (the computing system includes a virtual model generator module 112 which generates a model of an anatomical target 126 and further a model medical device to perform virtual guided surgical procedures or practice said procedures; abstract; figs 1, 4-5, and 12; paragraphs [0113-0117], [0123-0125]; claims 18) and a second model virtually representing an object (the second virtual model is a virtual model of a surgical tool/medical device used in the simulated operation; abstract; figs 1, 4-5, and 12; paragraphs [0113-0117], [0123-0125]; claims 18), wherein the processing unit is programmed to: process a projection image generated by an imaging device from an imaging direction, wherein the projection image includes at least a part of the anatomical structure and at least a part of the object (the computing system is adapted to create a virtual environment in which the virtual models of the anatomical target and the object which is a medical device/surgical tool are both projected into the virtual environment and interact with one another and provides haptic feedback to the user to simulate the actual process; abstract; figs 1, 4-5, and 12; paragraphs [0113-0117], [0123-0125]; claims 18); and determine a spatial position and orientation of the object relative to a space of movement based on (i) the projection image (a spatial position is determined in a standardized coordinate system which includes all virtual models generated by the model generator and all anatomical structures generated are centered about the spine which is used as a rigid object and has a relatively consistent position within the subject, the spine can be used as a universal fiducial marker in order to center the coordinate system and orient the medical device/surgical tool models wielded by the operator/user; figs 23A-23C, 24A-24C, 25A-25C; paragraphs [0088-0090], [0121], [0155-0160]; claims 1, 18, and 19), (ii) the imaging direction (the system is adapted to image the modeled anatomical structure at all arm angles in order to build a comprehensive 3D model which mimics anatomical motion such as moving into a diastole and systole cardiac positions; abstract; figs 1, 4-5, and 11-12; paragraphs [0075], [0106], [0113-0117], [0123-0125]; claims 18), (iii) the first model (the computing system is adapted to generate via the model generator generate a 3D model virtual representation of the anatomical targets of the patient being operated on; figs 1, 4-5, and 11-12; paragraphs [0075], [0106], [0113-0117], [0123-0125]; claim 18), and (iv) the second model (the computing system including the model generator is adapted to generate in the standard coordinate system in order to interact with the anatomical model using a medical device/surgical tool model acting as the object model; figs 1, 4-5, and 11-12; paragraphs [0075], [0106], [0113-0117], [0123-0125]; claim 18), wherein the space of movement is defined in relation to the anatomical structure (and the virtually generated anatomical model and the virtually generated surgical tool model is adapted for interaction and haptic feedback to the user when used on the anatomical model in the virtual space in order to perform simulated operations; figs 1, 4-5, and 11-12; paragraphs [0075], [0106], [0113-0117], [0123-0125]; claim 18).
As per claim 32, MOSADEGH discloses the device of claim 29 further comprising a robotic device, wherein the object is attached to the robotic device (the virtual model is adapted to be connected to a robotic system in the real world wherein the robotic arm mimics the motion of the virtual model in a closed loop instructional manner; claim 27).
As per claim 33, MOSADEGH discloses the device of claim 29, further comprising a sensor for the robotic device, wherein the determining of the spatial position and orientation of the object relative to the space of movement is further based on information received from the sensor (the computing system which controls a robotic arm wherein the robotic arm includes a sensor for imaging of various modalities which are synchronized with the system using direct image processing algorithms; fig 1; paragraphs [0105-0108], [0113], [0116]).
As per claim 34, MOSADEGH discloses the device of claim 29 further comprising a real-time navigation system selected from the group consisting of: a navigation system with optical trackers, a navigation system with infrared trackers, a navigation system with EM tracking, a navigation system utilizing a 2D camera, a navigation system utilizing Lidar, a navigation system utilizing a 3D camera, a navigation system including a wearable tracking element or a navigation system including augmented reality glasses, wherein determining the spatial position and orientation of the object relative to the space of movement is based on the real-time navigation system (system 100 can include a guidance system 102 that receives image data from a first imaging device 104 and second imaging device 106 which are cameras and used in order to track objects related to the generated virtual models and provides the ability to image object position and orientation; paragraphs [0113-0117]).
As per claim 35, MOSADEGH discloses the device of claim 29, wherein the first model is selected from the group consisting of: a (statistical) deformable shape model, a surface model, an (statistical) deformable appearance model, a surface model of a CT Scan, a surface model of a MR scan, a surface model of PET scan, a surface model of an intraoperative 3D x-ray, 3D image data of a CT scan, 3D image data of a PET Scan, 3D image data of an MR scan, 3D image data of an intraoperative 3D x-ray scan, or a combination thereof (the model generator 112 can receive the image data sets 134 from the first imaging device 104, the second imaging device 106, and/or the sensors 108 and includes CT image scans; paragraphs [0113-0117]).
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.
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 non-obviousness.
Claims 25-26, and 30-31 are rejected under 35 § U.S.C. 103 as being obvious over US 2023/0363832 A1 to MOSADEGH et al. (hereinafter “MOSADEGH”) in view of US 2017/0367766 A1 to MAHFOUZ (hereinafter “MAHFOUZ”).
As per claim 25, MOSADEGH discloses the method of claim 16. MOSADEGH fails to disclose further comprising: receiving a previous projection image from another imaging direction, the previous projection image including a further part of the anatomical structure; detecting a point or a line as a geometrical aspect of the object in the previous projection image; and detecting the geometrical aspect of the object in the projection image; wherein the geometrical aspect of the object did not move relative to the part of the anatomical structure between the point in time of generating the previous projection image and the point in time of generating the projection image, wherein the determination of a spatial position and orientation of the object relative to the space of movement is further based on the detected geometrical aspect of the object and knowledge that there has been no movement between the geometrical aspect of the object and the part of the anatomical structure between the point in time of generating the previous projection image and the point in time of generating the projection image.
MAHFOUZ discloses further comprising: receiving a previous projection image from another imaging direction, the previous projection image including a further part of the anatomical structure (the computing system for guided surgery receives models generated from images captured in all directions of the anatomical patient specific target, wherein the pre-operative steps include creating a virtual model of the patient-specific anatomy that will be the subject of the surgical procedure, the virtual anatomical model is created from a static imaging modalities, such as computed tomography CT, magnetic resonance imaging MRI and/or X-ray, other dynamic imaging modalities such as fluoroscopy or tracker enabled ultrasound; figs 6, 20; paragraphs [0131-0132]); detecting a point or a line as a geometrical aspect of the object in the previous projection image (the system is adapted to detect geometries relating to the implant shape and the anatomical structures further allowing a bone surface point to be found and included in the geometric model; figs 6, 20, and 25; paragraphs [0131-0134], [0206], [0224], [0254]); and detecting the geometrical aspect of the object in the projection image (self-referenced hybrid navigation module based on the UWB and IMU technologies is used to improve the accuracy of simultaneous translational and rotational tracking of surgical tools and surgeon/user during a surgical procedure; paragraphs [0125-0127]); wherein the geometrical aspect of the object did not move relative to the part of the anatomical structure between the point in time of generating the previous projection image and the point in time of generating the projection image, wherein the determination of a spatial position and orientation of the object relative to the space of movement is further based on the detected geometrical aspect of the object and knowledge that there has been no movement between the geometrical aspect of the object and the part of the anatomical structure between the point in time of generating the previous projection image and the point in time of generating the projection image (the geometrical representations of the anatomical models are corrected for error in estimation of the models, the models are corrected based on known anatomical proportions of the subject in order to provide a match from the model to the anatomical target for surgery and further include the orientation of the surgical tool used in the surgery and represented in the virtual VR environment; figs 57-62; paragraphs [0234], [0256-0264]).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify MOSADEGH to have a previous projection image from another imaging direction, the previous projection image including a further part of the anatomical structure of MAHFOUZ reference. The Suggestion/motivation for doing so would have been to provide the ability to simulate and evaluate intra-operative kinematics during and after operation in a virtual environment, where this example process presumes that the cuts are performed as planned for joint replacement are properly performed in an operating room to simulate the results and plan the surgery without having to actually perform the cuts as suggested by fig 26 and paragraph [0207] of MAHFOUZ. Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine MAHFOUZ with MOSADEGH to obtain the invention as specified in claim 25.
As per claim 26, MOSADEGH discloses the method of claim 16. MOSADEGH fails to disclose further comprising: receiving a previous projection image from another imaging direction, the previous projection image including a further part of the anatomical structure; and determining an imaging direction onto a first part of the object in the previous projection image, to determine an imaging direction onto a second part of the object in the projection image; wherein the object did not move relative to the part of the anatomical structure between the point in time of generating the previous projection image and the point in time of generating the projection image, wherein the determination of a spatial position and orientation of the object relative to the space of movement is further based on the determined imaging directions onto the parts of the object and knowledge that there has been no movement between the object and the part of the anatomical structure between the point in time of generating the previous projection image and the point in time of generating the projection image.
MAHFOUZ discloses further comprising: receiving a previous projection image from another imaging direction, the previous projection image including a further part of the anatomical structure (the computing system for guided surgery receives models generated from images captured in all directions of the anatomical patient specific target, wherein the pre-operative steps include creating a virtual model of the patient-specific anatomy that will be the subject of the surgical procedure, the virtual anatomical model is created from a static imaging modalities, such as computed tomography CT, magnetic resonance imaging MRI and/or X-ray, other dynamic imaging modalities such as fluoroscopy or tracker enabled ultrasound; figs 6, 20; paragraphs [0131-0132]); and determining an imaging direction onto a first part of the object in the previous projection image, to determine an imaging direction onto a second part of the object in the projection image (the system is adapted to detect geometries relating to the implant shape and the anatomical structures further allowing a bone surface point to be found and included in the geometric model; figs 6, 20, and 25; paragraphs [0131-0134], [0206], [0224], [0254]); wherein the object did not move relative to the part of the anatomical structure between the point in time of generating the previous projection image and the point in time of generating the projection image (self-referenced hybrid navigation module based on the UWB and IMU technologies is used to improve the accuracy of simultaneous translational and rotational tracking of surgical tools and surgeon/user during a surgical procedure; paragraphs [0125-0127]), wherein the determination of a spatial position and orientation of the object relative to the space of movement is further based on the determined imaging directions onto the parts of the object and knowledge that there has been no movement between the object and the part of the anatomical structure between the point in time of generating the previous projection image and the point in time of generating the projection image (the geometrical representations of the anatomical models are corrected for error in estimation of the models, the models are corrected based on known anatomical proportions of the subject in order to provide a match from the model to the anatomical target for surgery and further include the orientation of the surgical tool used in the surgery and represented in the virtual VR environment; figs 57-62; paragraphs [0234], [0256-0264]).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify MOSADEGH to have receive a previous projection image from another imaging direction, the previous projection image including a further part of the anatomical structure of MAHFOUZ reference. The Suggestion/motivation for doing so would have been to provide the ability to simulate and evaluate intra-operative kinematics during and after operation in a virtual environment, where this example process presumes that the cuts are performed as planned for joint replacement are properly performed in an operating room to simulate the results and plan the surgery without having to actually perform the cuts as suggested by fig 26 and paragraph [0207] of MAHFOUZ. Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine MAHFOUZ with MOSADEGH to obtain the invention as specified in claim 26.
As per claim 30, MOSADEGH discloses the device of claim 29. MOSADEGH fails to disclose wherein the processing unit is further programmed to: receive a previous projection image from another imaging direction, the previous projection image including a further part of the anatomical structure; detect a point or a line as a geometrical aspect of the object in the previous projection image; and detect the geometrical aspect of the object in the projection image; wherein the geometrical aspect of the object did not move relative to the part of the anatomical structure between the point in time of generating the previous projection image and the point in time of generating the projection image; wherein the determination of a spatial position and orientation of the object relative to the space of movement is further based on the detected geometrical aspect of the object and knowledge that there has been no movement between the geometrical aspect of the object and the part of the anatomical structure between the point in time of generating the previous projection image and the point in time of generating the projection image.
MAHFOUZ discloses wherein the processing unit is further programmed to: receive a previous projection image from another imaging direction, the previous projection image including a further part of the anatomical structure (the computing system for guided surgery receives models generated from images captured in all directions of the anatomical patient specific target, wherein the pre-operative steps include creating a virtual model of the patient-specific anatomy that will be the subject of the surgical procedure, the virtual anatomical model is created from a static imaging modalities, such as computed tomography CT, magnetic resonance imaging MRI and/or X-ray, other dynamic imaging modalities such as fluoroscopy or tracker enabled ultrasound; figs 6, 20; paragraphs [0131-0132]); detect a point or a line as a geometrical aspect of the object in the previous projection image (the system is adapted to detect geometries relating to the implant shape and the anatomical structures further allowing a bone surface point to be found and included in the geometric model; figs 6, 20, and 25; paragraphs [0131-0134], [0206], [0224], [0254]); and detect the geometrical aspect of the object in the projection image (self-referenced hybrid navigation module based on the UWB and IMU technologies is used to improve the accuracy of simultaneous translational and rotational tracking of surgical tools and surgeon/user during a surgical procedure; paragraphs [0125-0127]); wherein the geometrical aspect of the object did not move relative to the part of the anatomical structure between the point in time of generating the previous projection image and the point in time of generating the projection image (the generated medical device/surgical tool model is moved in the virtual space based on movement of the user holding the device in the real world if the user does not move the tool in the real world the motion is not geometrically translated to the virtual model world; figs 57-62; paragraphs [0234], [0256-0264]); wherein the determination of a spatial position and orientation of the object relative to the space of movement is further based on the detected geometrical aspect of the object and knowledge that there has been no movement between the geometrical aspect of the object and the part of the anatomical structure between the point in time of generating the previous projection image and the point in time of generating the projection image (the geometrical representations of the anatomical models are corrected for error in estimation of the models, the models are corrected based on known anatomical proportions of the subject in order to provide a match from the model to the anatomical target for surgery and further include the orientation of the surgical tool used in the surgery and represented in the virtual VR environment; figs 57-62; paragraphs [0234], [0256-0264]).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify MOSADEGH to have receive a previous projection image from another imaging direction, the previous projection image including a further part of the anatomical structure of MAHFOUZ reference. The Suggestion/motivation for doing so would have been to provide the ability to simulate and evaluate intra-operative kinematics during and after operation in a virtual environment, where this example process presumes that the cuts are performed as planned for joint replacement are properly performed in an operating room to simulate the results and plan the surgery without having to actually perform the cuts as suggested by fig 26 and paragraph [0207] of MAHFOUZ. Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine MAHFOUZ with MOSADEGH to obtain the invention as specified in claim 30.
As per claim 31, MOSADEGH discloses the device of claim 29. MOSADEGH fails to disclose wherein the processing unit is further programmed to: receive a previous projection image from another imaging direction, the previous projection image including a further part of the anatomical structure; and determine an imaging direction onto a first part of the object in the previous projection image, to determine an imaging direction onto a second part of the object in the projection image; wherein the object did not move relative to the part of the anatomical structure between the point in time of generating the previous projection image and the point in time of generating the projection image; wherein the determination of a spatial position and orientation of the object relative to the space of movement is further based on the determined imaging directions onto the parts of the object and knowledge that there has been no movement between the object and the part of the anatomical structure between the point in time of generating the previous projection image and the point in time of generating the projection image.
MAHFOUZ discloses wherein the processing unit is further programmed to: receive a previous projection image from another imaging direction, the previous projection image including a further part of the anatomical structure (the computing system for guided surgery receives models generated from images captured in all directions of the anatomical patient specific target, wherein the pre-operative steps include creating a virtual model of the patient-specific anatomy that will be the subject of the surgical procedure, the virtual anatomical model is created from a static imaging modalities, such as computed tomography CT, magnetic resonance imaging MRI and/or X-ray, other dynamic imaging modalities such as fluoroscopy or tracker enabled ultrasound; figs 6, 20; paragraphs [0131-0132]); and determine an imaging direction onto a first part of the object in the previous projection image, to determine an imaging direction onto a second part of the object in the projection image (the system is adapted to detect geometries relating to the implant shape and the anatomical structures further allowing a bone surface point to be found and included in the geometric model; figs 6, 20, and 25; paragraphs [0131-0134], [0206], [0224], [0254]); wherein the object did not move relative to the part of the anatomical structure between the point in time of generating the previous projection image and the point in time of generating the projection image (self-referenced hybrid navigation module based on the UWB and IMU technologies is used to improve the accuracy of simultaneous translational and rotational tracking of surgical tools and surgeon/user during a surgical procedure; paragraphs [0125-0127]); wherein the determination of a spatial position and orientation of the object relative to the space of movement is further based on the determined imaging directions onto the parts of the object and knowledge that there has been no movement between the object and the part of the anatomical structure between the point in time of generating the previous projection image and the point in time of generating the projection image (the geometrical representations of the anatomical models are corrected for error in estimation of the models, the models are corrected based on known anatomical proportions of the subject in order to provide a match from the model to the anatomical target for surgery and further include the orientation of the surgical tool used in the surgery and represented in the virtual VR environment; figs 57-62; paragraphs [0234], [0256-0264]).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify MOSADEGH to have receive a previous projection image from another imaging direction, the previous projection image including a further part of the anatomical structure of MAHFOUZ reference. The Suggestion/motivation for doing so would have been to provide the ability to simulate and evaluate intra-operative kinematics during and after operation in a virtual environment, where this example process presumes that the cuts are performed as planned for joint replacement are properly performed in an operating room to simulate the results and plan the surgery without having to actually perform the cuts as suggested by fig 26 and paragraph [0207] of MAHFOUZ. Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, it would have been obvious to combine MAHFOUZ with MOSADEGH to obtain the invention as specified in claim 31.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Examiner's Note: Examiner has cited figures, and paragraphs in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested for the applicant, in preparing the responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner. Examiner has also cited references in PTO892 but not relied on, which are relevant and pertinent to the applicant’s disclosure, and may also be reading (anticipatory/obvious) on the claims and claimed limitations. Applicant is advised to consider the references in preparing the response/amendments in-order to expedite the prosecution.
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/D J DHOOGE/Examiner, Art Unit 2677
/ANDREW W BEE/Supervisory Patent Examiner, Art Unit 2677
