DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Claim(s) 1-3, 5-6, 9-16, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dorman (U.S. Pub. No. 2016/0235481) in view of Peshkin et al. (U.S. Doc. No. 5799055).
Regarding claim 1, Dorman discloses a method for simulating a three-dimensional orientation of a medical device about a desired insertion point in an anatomical structure (paragraph 6, line(s) 1-4, "A method disclosed herein includes simulating an insertion point and an orientation of a simulated surgical hardware installation on a diagnostic representation of the bone"; also, paragraph 69, line(s) 4-7, "More than one orientation apparatus 330 may be used at the same time to give a three-dimensional viewing. Surgical apparatus may include pedicle screws, gearshift probes, and other medical devices"; also, paragraph 67, line(s) 5-9, "images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented") the method comprising: displaying, by one or more processors (para 9, “The system includes an image acquisition unit, an orientation sensor, a display, and a processor.”), a first movable marker representing an insertion point in the anatomical structure (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”), the first movable marker superimposed on a first diagnostic representation of the anatomical structure at the desired insertion point (paragraph 63, line(s) 1-3, "The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw"; also, paragraph 48, line(s) 1-3, "definitions of the insertion sagittal angle 370 of the pilot hole 220 and the initial position 375 of the pilot hole are provided by a user"); displaying, by the one or more processors, a simulated medical device superimposed on the first diagnostic representation of the anatomical structure (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”; also, para 59, “FIG. 6A illustrates an interface 600 for selecting vertebra of a patient, FIG. 6B illustrates aligning the axis 305 of the apparatus 300 with the sagittal plane, FIG. 6C illustrates defining a pedicle screw's position and its sagittal angle 370, and FIG. 6D illustrates generating an angle-indicative line 652 for showing the angle between the longitudinal axis of the apparatus and the sagittal plane.”) in an inserted position at the desired insertion point (para 63, The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”); rotating, by the one or more processors, the simulated medical device about the desired insertion point (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”) to a first desired position relative to the first diagnostic representation of the anatomical structure (paragraph 63, " The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635."; also, paragraph 48, line(s) 1-3, "definitions of the insertion sagittal angle 370 of the pilot hole 220 and the initial position 375 of the pilot hole are provided by a user"); displaying, by the one or more processors a second movable marker representing the insertion point in the anatomical structure (para 67, “For example, the apparatus 300 may also use a second or more views to define various angles not limited within the sagittal plane.”; also, para 48, “At 530, definitions of the insertion sagittal angle 370 of the pilot hole 220 and the initial position 375 of the pilot hole are provided by a user.”), the second movable marker superimposed on a second diagnostic representation of the anatomical structure (para 67, “For example, the apparatus 300 may also use a second or more views to define various angles not limited within the sagittal plane.”; also, para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented.”) while maintaining a position relative to the desired insertion point in the anatomical structure in the first diagnostic representation of the anatomical structure (para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented.”; also, para 48, “At 530, definitions of the insertion sagittal angle 370 of the pilot hole 220 and the initial position 375 of the pilot hole are provided by a user.”); displaying, by the one or more processors, the simulated medical device superimposed on the second diagnostic representation of the anatomical structure (para 67, “For example, the apparatus 300 may also use a second or more views to define various angles not limited within the sagittal plane.”; also, para 54, “At 590, an angle-indicative line for the corresponding transverse angle is generated by a processor and displayed on the display 360.”) in the inserted position at the desired insertion point (para 59, “In some embodiments, the angle-indicative line may represent a virtual gearshift probe, or other instrument for aligning a pedicle screw or pilot hole."), rotating, by the one or more processors, the simulated medical device about the desired insertion point (para 54, “The angle-indicative line can rotate in response to the apparatus 300 rotation and provides a notification when the apparatus 300 approximately forms the insertion transverse angle, as defined in step 580, between the apparatus 300 longitudinal axis 305 and the transverse plane.”; also, para 58, “The angle-indicative line can rotate in response to the apparatus 300 rotation and provides a notification when the apparatus 300 approximately forms the insertion coronal angle between the apparatus 300 longitudinal axis 305 and the coronal plane.”) to a second desired position relative to the second diagnostic representation of the anatomical structure (para 53, “At 580, definitions of the insertion angle in the transverse plane 130, and the initial position 375 of the pilot hole are provided by a user, as similar to the sagittal angle defined at 530."; also, para 57, “At 585, respective definitions of the insertion angle in the coronal plane 120, and the initial position 375 of the pilot hole are provided by a user, as similar to the sagittal angle defined at 530.”); and recording, by the one or more processors, a resultant three-dimensional orientation of the simulated medical device (para 36, “Memory storage unit 352 saves data related to at least an operating system, application, and patient profiles.”; also, para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented.”) relative to the desired insertion point as a target (para 9, “The processor is further configured to receive definitions of an insertion sagittal angle, transverse angle, or coronal angle of the tract and an initial position thereof relative to the vertebra, and generate an angle-indicative line on the display, wherein the angle-indicative line rotates in response to rotation of the system, and provides a notification when at least a portion of the system approximately forms the insertion sagittal angle, transverse angle, or coronal angle between an axis of the apparatus and the sagittal plane, transverse plane, or coronal plane of the vertebrae."; also, para 43, “First an insertion point and an orientation of a simulated surgical hardware installation are simulated on a diagnostic representation of a bone 502.”; also, para 45, “Using the electronic device to align the instrument for inserting the surgical hardware installation at the desired orientation through the insertion point includes aligning the electronic device with the instrument at the insertion point 508, tracking movement of the electronic device and the instrument using an orientation sensor of the electronic device until the orientation of the electronic device and the instrument are within the threshold of the simulated orientation 509, and indicating when the electronic device and the instrument are within the threshold of the simulated orientation 511.”). Dorman does not disclose wherein the simulated medical device in the second diagnostic representation is constrained to a selection made in the first diagnostic representation.
However, in a similar field of endeavor, Peshkin discloses wherein the simulated medical device in the second diagnostic representation is constrained to a selection made in the first diagnostic representation (col 3, “In coordinated fluoroscopy, the geometric projections that relate the two images to a single three-dimensional coordinate system are established before planning commences. The points chosen by the surgeon on two (or more) images can therefore be constrained by the software such that they DO correspond to a well-defined point in three-dimensions. In practice, as a surgeon adjusts an intended point or line segment on one image, the point or line segment displayed on the other image(s) continuously updates and adjusts as well. One cannot draw "arbitrary" points or line segments independently on the images; the software only allows one to draw points or line segments that correspond to a well-defined point or line segment in three-dimensions.”; also, para 8, “The projected guidewire 68 is a line segment which is displayed on the sagittal image area representing the position of the instrumentation to be inserted during the stereotactic surgical procedure. A line of sight 70 is also displayed in the sagittal image area 62.”; also, col 16, “If a cursor is over the A/P image area 86 of FIG. 3a, computer 40 advances to block 476 of FIG. 16A. Computer 40 waits for the trackball to be clicked in the A/P image area 86 as illustrated at block 478.”; also, col 16, “If the A/P and the sagittal images have been registered at block 480, computer 40 determines whether the projected guidewire is drawn as illustrated at block 484. If not, computer 40 assumes that the operator intends to draw the projected guidewire. Therefore, the computer 40 draws a cross hair at trackball coordinate (U,V) as illustrated at block 486. Next, computer 40 draws a curve representing the line of site on the sagittal image using the equations of section [5] of the attached Appendix as illustrated at block 488.”; also, col 18, “If the trackball coordinates are within five pixels of the top point 64 at block 516, computer 40 determines whether the trackball has been clicked again at block 522. If so, computer 40 returns at block 524 to wait for the next command. If not, computer 40 updates the position of the virtual guidewire 68 by moving it along the line of sight in the same direction as the trackball movements.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dorman's invention of a method for simulating the orientation of a pedicle screw about its insertion point, in which the processor displays crosshairs that the user moves to the cortical entry point of the screw on a diagnostic image of the vertebra, displays the screw at that entry point and rotates it to its desired position, uses a second or more views to define angles not limited within the sagittal plane, displays and rotates an instrument for aligning the pedicle screw in that second view, and records the resulting alignment as the simulated orientation against which the instrument is later tracked, with the features of Peshkin's invention of constraining a virtual guidewire displayed on a second image to the point selected on a first image, in which a cross hair placed on the anterior/posterior image produces a line of sight drawn on the sagittal image, the virtual guidewire in the sagittal image is moved along that line of sight, and the software only allows points or line segments to be drawn on the images that correspond to a well-defined point or line segment in three dimensions. The combination would have been obvious because Dorman defines an insertion position and an angle in each of its views and uses those views to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented, and that three-dimensional result exists only if the points defined in the separate views correspond to one point in the bone. Peshkin, working on the same task of planning the insertion of surgical instrumentation on two-dimensional images of a patient, teaches that the points chosen by the surgeon on two images can be constrained by the software such that they correspond to a well-defined point in three dimensions, and implements that constraint by moving the guidewire in the second image along the line of sight of the selection made in the first. A person of ordinary skill implementing Dorman's second view would have applied Peshkin's constraint so that the simulated screw placed on the second diagnostic representation stays tied to the entry point selected on the first, with the predictable result that the two planar definitions yield a single, consistent three-dimensional orientation of the screw.
Regarding claim 2, Dorman as modified by Peshkin discloses the method of claim 1, wherein Dorman further comprising: moving, by the one or more processors, the first movable marker to the desired insertion point in the anatomical structure as represented by the first diagnostic representation of the anatomical structure in a first view (paragraph 63, line(s) 1-3, "The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw"; also, FIG. 6C); and moving, by the one or more processors, the second movable marker to the desired insertion point in the anatomical structure as represented by the second diagnostic representation of the anatomical structure in a second view (paragraph 67, line(s) 2-4, "the apparatus 300 may also use a second or more views to define various angles not limited within the sagittal plane."; also, paragraph 52, line(s) 1-2, "the image of the posterior view is captured in the coronal plane"; also, paragraph 53, line(s) 1-3, "definitions of the insertion angle in the transverse plane 130, and the initial position 375 of the pilot hole are provided by a user"; also, paragraph 57, line(s) 1-3, "respective definitions of the insertion angle in the coronal plane 120, and the initial position 375 of the pilot hole are provided by a user").
Regarding claim 3, Dorman as modified by Peshkin discloses the method of claim 1, wherein Dorman further discloses the anatomical structure is a bone (paragraph 43, line(s) 2-3, "surgical hardware installation are simulated on a diagnostic representation of a bone").
Regarding claim 5, Dorman as modified by Peshkin discloses the method of claim 1, wherein Dorman further discloses rotating the simulated medical device about the insertion point includes rotating the simulated medical device in a first view of the first diagnostic representation of the anatomical structure and in a second view of the second diagnostic representation of the anatomical structure (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”; also, para 53, “At 580, definitions of the insertion angle in the transverse plane 130, and the initial position 375 of the pilot hole are provided by a user, as similar to the sagittal angle defined at 530.”; also, para 54, “At 590, an angle-indicative line for the corresponding transverse angle is generated by a processor and displayed on the display 360.”; also, para 54, “The angle-indicative line can rotate in response to the apparatus 300 rotation and provides a notification when the apparatus 300 approximately forms the insertion transverse angle, as defined in step 580, between the apparatus 300 longitudinal axis 305 and the transverse plane.”; also, para 67, “For example, the apparatus 300 may also use a second or more views to define various angles not limited within the sagittal plane.”), the second view at a known angle relative to the first view (para 28, “FIG. 1 illustrates a sagittal or median plane 110, a coronal or frontal plane 120, and a transverse or horizontal plane 130 relative to a patient's body part 100 located at the intersection of the sagittal plane 110, coronal plane 120, and transverse plane 130. Each plane is orthogonal to each other.”), and wherein the resultant three-dimensional orientation of the simulated medical device is determined based at least upon the known angle (para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented."; also, para 9, “The processor is further configured to receive definitions of an insertion sagittal angle, transverse angle, or coronal angle of the tract and an initial position thereof relative to the vertebra, and generate an angle-indicative line on the display, wherein the angle-indicative line rotates in response to rotation of the system, and provides a notification when at least a portion of the system approximately forms the insertion sagittal angle, transverse angle, or coronal angle between an axis of the apparatus and the sagittal plane, transverse plane, or coronal plane of the vertebrae.”; also, para 43, “First an insertion point and an orientation of a simulated surgical hardware installation are simulated on a diagnostic representation of a bone 502.”; also, para 45, “Using the electronic device to align the instrument for inserting the surgical hardware installation at the desired orientation through the insertion point includes aligning the electronic device with the instrument at the insertion point 508, tracking movement of the electronic device and the instrument using an orientation sensor of the electronic device until the orientation of the electronic device and the instrument are within the threshold of the simulated orientation 509, and indicating when the electronic device and the instrument are within the threshold of the simulated orientation 511.”).
Regarding claim 6, Dorman as modified by Peshkin discloses the method of claim 5, wherein Dorman further discloses the first view is an axial view of the first diagnostic representation of the anatomical structure (para 48, “At 530, definitions of the insertion sagittal angle 370 of the pilot hole 220 and the initial position 375 of the pilot hole are provided by a user.”; also, para 30, “In some embodiments, the image 310 may be obtained by positioning the apparatus 300 and/or image acquisition unit 320 in parallel with the transverse, sagittal, or coronal plane to obtain an image of the vertebra.”; also, para 51, “FIG. 5C illustrates a flow chart 550 of an implementation for indicating a transverse angle, which is an angle with respect to the transverse plane of the vertebra.”), and the second view is a lateral view of the second diagnostic representation of the anatomical structure (para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented.").
Regarding claim 9, Dorman as modified by Peshkin discloses the method of claim 1, wherein Dorman further comprising: displaying, by the one or more processors, the target orientation (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”; also, para 49, “At 540, an angle-indicative line is generated by a processor and displayed on the display 360.”; also, para 49, “The angle-indicative line can rotate in response to the apparatus 300 rotation and provides a notification when the apparatus 300 approximately forms the insertion sagittal angle 370 between the apparatus 300 longitudinal axis 305 and the sagittal plane.”); displaying, by the one or more processors, a current orientation of a surgical instrument relative to the target orientation (paragraph 64, line(s) 1-8, " a virtual gearshift probe 652 appears on the screen. The gearshift probe's orientation matches the orientation of the apparatus 300. In some embodiments, once the angle of the gearshift probe 652 is about 20 degrees within the selected trajectory, the gearshift probe 652 will turn yellow, at 5 degrees, it will turn green, and when the alignment is within 1 degree of the target angle, a green line 654 will extend outward"; also, paragraph 45, line(s) 5-9, "tracking movement of the electronic device and the instrument using an orientation sensor of the electronic device until the orientation of the electronic device and the instrument are within the threshold of the simulated orientation 509,"; and in response to the current orientation of the surgical instrument satisfying a positional threshold relative to the target orientation, presenting, by the one or more processors, an indication of alignment (paragraph 64, line(s) 4-9, "once the angle of the gearshift probe 652 is about 20 degrees within the selected trajectory, the gearshift probe 652 will turn yellow, at 5 degrees, it will turn green, and when the alignment is within 1 degree of the target angle, a green line 654 will extend outward and the pedicle screw will disappear."; also, para 7,” The processor is configured to simulate insertion of the medical device in an image of the bone to determine a desired insertion angle of the medical device relative to a plane of the bone, determine an orientation of the electronic device relative to the plane using the orientation sensor, and output a notification when the orientation of the electronic device is such that the electronic device is positioned adjacent the desired angle of the medical device relative to the plane.”).
Regarding claim 10, Dorman as modified by Peshkin discloses the method of claim 1, wherein Dorman further discloses the first movable marker is an image of a crosshair, bullseye, or a reticle (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”).
Regarding claim 11, Dorman as modified by Peshkin discloses the method of claim 1, wherein Dorman further discloses displaying the first diagnostic representation of the anatomical structure includes displaying the first diagnostic representation of the anatomical structure in a plane that is an axial plane, coronal plane, or a sagittal plane (para 30, “In some embodiments, the image 310 may be obtained by positioning the apparatus 300 and/or image acquisition unit 320 in parallel with the transverse, sagittal, or coronal plane to obtain an image of the vertebra.”; also, para 28, “FIG. 1 illustrates a sagittal or median plane 110, a coronal or frontal plane 120, and a transverse or horizontal plane 130 relative to a patient's body part 100 located at the intersection of the sagittal plane 110, coronal plane 120, and transverse plane 130. Each plane is orthogonal to each other.”; also, para 31, “In some embodiments, the image acquisition unit 320 can be a camera having sufficient field of view 360 to properly align the axis 305 of the apparatus 300 with the desired plane.”).
Regarding claim 12, Dorman as modified by Peshkin discloses the method of claim 1, wherein Dorman further discloses the first diagnostic representation of the anatomical structure and the second diagnostic representation of the anatomical structure is a pictorial view of the anatomical structure, an x-ray of the anatomical structure, a radiograph of the anatomical structure, a computed tomography scan of the anatomical structure, or a magnetic resonance image of the anatomical structure (paragraph 32, line(s) 3-7, "the image acquisition unit 320 can directly use an image taken from an external machine (not illustrated), such as a radiograph, computed tomography (CT) scanner, or a magnetic resonance imaging (MRI) machine.").
Regarding claim 13, Dorman as modified by Peshkin discloses the method of claim 1, wherein Dorman further discloses the first diagnostic representation of the anatomical structure is a superior view of the anatomical structure, a lateral view of the anatomical structure, or a posterior view of the anatomical structure (para 29, “FIG. 2A illustrates a cross sectional view (i.e., superior view) 200 of a vertebra 205 having pedicle screws 210 installed in respective pilot holes 220."; also, para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented.”).
Regarding claim 14, Dorman discloses an apparatus for simulating a three-dimensional orientation of a medical device (para 7, “An apparatus disclosed herein is for determining orientation of an instrument for inserting a medical device in a bone”; also, para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented.”) rotatable about a desired insertion point in an anatomical structure, the apparatus comprising (para 43, ‘First an insertion point and an orientation of a simulated surgical hardware installation are simulated on a diagnostic representation of a bone 502.”; also, para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”): an electronic device comprising one or more processors configured to (paragraph 35, line(s) 2-3, "the apparatus 300 further includes a processor 350"; also, paragraph 47, line(s) 2-4, " the apparatus 300 includes a smart phone, a tablet computer, a laptop computer, or any portable computational device"; also, para 35, “The processor 350 can be any processing unit capable of basic computation and capable of executing a program, software, firmware, or any application commonly known in the art of computer science.”): display a first movable marker representing an insertion point in the anatomical structure (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”), the first movable marker superimposed on a first diagnostic representation of the anatomical structure (paragraph 63, line(s) 1-3, "The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw"; also, FIG. 6C); display a simulated medical device superimposed on the first diagnostic representation of the anatomical structure (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”) in an inserted position at the desired insertion point (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”); rotate the simulated medical device about the desired insertion point (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”; also, para 49, “The angle-indicative line can rotate in response to the apparatus 300 rotation and provides a notification when the apparatus 300 approximately forms the insertion sagittal angle 370 between the apparatus 300 longitudinal axis 305 and the sagittal plane.”) to a first desired position relative to the first diagnostic representation of the anatomical structure (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635."); display a second movable marker representing the insertion point in the anatomical structure (para 57, “At 585, respective definitions of the insertion angle in the coronal plane 120, and the initial position 375 of the pilot hole are provided by a user, as similar to the sagittal angle defined at 530.”), the second movable marker superimposed on a second diagnostic representation of the anatomical structure (para 67, “For example, the apparatus 300 may also use a second or more views to define various angles not limited within the sagittal plane.”; also, para 52, “At 570, the image of the posterior view is captured in the coronal plane.”), while maintaining a position relative to the desired insertion point in the anatomical structure in the first diagnostic representation of the anatomical structure (para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented."; also, para 57, “At 585, respective definitions of the insertion angle in the coronal plane 120, and the initial position 375 of the pilot hole are provided by a user, as similar to the sagittal angle defined at 530.”); display the simulated medical device superimposed on the second diagnostic representation of the anatomical structure (para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented.”; also, para 49, “The angle-indicative line can rotate in response to the apparatus 300 rotation and provides a notification when the apparatus 300 approximately forms the insertion sagittal angle 370 between the apparatus 300 longitudinal axis 305 and the sagittal plane.”) in the inserted position at the desired insertion point (para 59, “In some embodiments, the angle-indicative line may represent a virtual gearshift probe, or other instrument for aligning a pedicle screw or pilot hole."), rotate the simulated medical device about the desired insertion point (para 59, “The angle-indicative line can rotate in response to the apparatus 300 rotation and provides a notification when the apparatus 300 approximately forms the insertion coronal angle between the apparatus 300 longitudinal axis 305 and the coronal plane.”) to a second desired position relative to the second diagnostic representation of the anatomical structure (para 48, “At 530, definitions of the insertion sagittal angle 370 of the pilot hole 220 and the initial position 375 of the pilot hole are provided by a user.”); and record a resultant three-dimensional orientation of the simulated medical device (para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented.“) relative to the insertion point as a target orientation (para 45, “Using the electronic device to align the instrument for inserting the surgical hardware installation at the desired orientation through the insertion point includes aligning the electronic device with the instrument at the insertion point 508, tracking movement of the electronic device and the instrument using an orientation sensor of the electronic device until the orientation of the electronic device and the instrument are within the threshold of the simulated orientation 509, and indicating when the electronic device and the instrument are within the threshold of the simulated orientation 511. "; also, para 9, “The processor is further configured to receive definitions of an insertion sagittal angle, transverse angle, or coronal angle of the tract and an initial position thereof relative to the vertebra, and generate an angle-indicative line on the display, wherein the angle-indicative line rotates in response to rotation of the system, and provides a notification when at least a portion of the system approximately forms the insertion sagittal angle, transverse angle, or coronal angle between an axis of the apparatus and the sagittal plane, transverse plane, or coronal plane of the vertebrae.”). Dorman does not disclose wherein the simulated medical device in the second diagnostic representation is constrained to a selection made in the first diagnostic representation.
However, in a similar field of endeavor, Peshkin discloses wherein the simulated medical device in the second diagnostic representation is constrained to a selection made in the first diagnostic representation (col 3, “In coordinated fluoroscopy, the geometric projections that relate the two images to a single three-dimensional coordinate system are established before planning commences. The points chosen by the surgeon on two (or more) images can therefore be constrained by the software such that they DO correspond to a well-defined point in three-dimensions. In practice, as a surgeon adjusts an intended point or line segment on one image, the point or line segment displayed on the other image(s) continuously updates and adjusts as well. One cannot draw "arbitrary" points or line segments independently on the images; the software only allows one to draw points or line segments that correspond to a well-defined point or line segment in three-dimensions.”; also, col 8, “The projected guidewire 68 is a line segment which is displayed on the sagittal image area representing the position of the instrumentation to be inserted during the stereotactic surgical procedure. A line of sight 70 is also displayed in the sagittal image area 62.”; also, col 16, “If a cursor is over the A/P image area 86 of FIG. 3a, computer 40 advances to block 476 of FIG. 16A. Computer 40 waits for the trackball to be clicked in the A/P image area 86 as illustrated at block 478.”; also, col 16, “If the A/P and the sagittal images have been registered at block 480, computer 40 determines whether the projected guidewire is drawn as illustrated at block 484. If not, computer 40 assumes that the operator intends to draw the projected guidewire. Therefore, the computer 40 draws a cross hair at trackball coordinate (U,V) as illustrated at block 486. Next, computer 40 draws a curve representing the line of site on the sagittal image using the equations of section [5] of the attached Appendix as illustrated at block 488.”; also, col 18, “If the trackball coordinates are within five pixels of the top point 64 at block 516, computer 40 determines whether the trackball has been clicked again at block 522. If so, computer 40 returns at block 524 to wait for the next command. If not, computer 40 updates the position of the virtual guidewire 68 by moving it along the line of sight in the same direction as the trackball movements.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dorman's invention of an apparatus for determining the orientation of a pedicle screw about its insertion point, in which an electronic device having a processor displays crosshairs that the user moves to the cortical entry point of the screw on a diagnostic image of the vertebra, displays the screw at that entry point and rotates it to its desired position, uses a second or more views to define angles not limited within the sagittal plane, displays and rotates an instrument for aligning the pedicle screw in that second view, and records the resulting alignment as the simulated orientation against which the instrument is later tracked, with the features of Peshkin's invention of constraining a virtual guidewire displayed on a second image to the point selected on a first image, in which a cross hair placed on the anterior/posterior image produces a line of sight drawn on the sagittal image, the virtual guidewire in the sagittal image is moved along that line of sight, and the software only allows points or line segments to be drawn on the images that correspond to a well-defined point or line segment in three dimensions. The combination would have been obvious because Dorman defines an insertion position and an angle in each of its views and uses those views to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented, and that three-dimensional result exists only if the points defined in the separate views correspond to one point in the bone. Peshkin, working on the same task of planning the insertion of surgical instrumentation on two-dimensional images of a patient, teaches that the points chosen by the surgeon on two images can be constrained by the software such that they correspond to a well-defined point in three dimensions, and implements that constraint by moving the guidewire in the second image along the line of sight of the selection made in the first. A person of ordinary skill implementing Dorman's second view would have applied Peshkin's constraint so that the simulated screw placed on the second diagnostic representation stays tied to the entry point selected on the first, with the predictable result that the two planar definitions yield a single, consistent three-dimensional orientation of the screw.
Regarding claim 15, Dorman as modified by Peshkin discloses the apparatus of claim 14, wherein Dorman further discloses rotating the simulated medical device about the insertion point includes rotating the simulated medical device in a first view of the first diagnostic representation of the anatomical structure and in a second view of the second diagnostic representation of the anatomical structure (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”; also, para 54, “The angle-indicative line can rotate in response to the apparatus 300 rotation and provides a notification when the apparatus 300 approximately forms the insertion transverse angle, as defined in step 580, between the apparatus 300 longitudinal axis 305 and the transverse plane.”), the second view at a known angle relative to the first view (para 28, “FIG. 1 illustrates a sagittal or median plane 110, a coronal or frontal plane 120, and a transverse or horizontal plane 130 relative to a patient's body part 100 located at the intersection of the sagittal plane 110, coronal plane 120, and transverse plane 130. Each plane is orthogonal to each other."), wherein the resultant three-dimensional orientation of the simulated medical device is determined based at least upon the known angle (para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented. “; also, para 9, “The processor is further configured to receive definitions of an insertion sagittal angle, transverse angle, or coronal angle of the tract and an initial position thereof relative to the vertebra, and generate an angle-indicative line on the display, wherein the angle-indicative line rotates in response to rotation of the system, and provides a notification when at least a portion of the system approximately forms the insertion sagittal angle, transverse angle, or coronal angle between an axis of the apparatus and the sagittal plane, transverse plane, or coronal plane of the vertebrae.").
Regarding to claim 16, Dorman as modified by Peshkin discloses the apparatus of claim 15, wherein Dorman further discloses the first view is an axial view of the first diagnostic representation of the anatomical structure (para 48, “At 530, definitions of the insertion sagittal angle 370 of the pilot hole 220 and the initial position 375 of the pilot hole are provided by a user.”; also, para 30, “In some embodiments, the image 310 may be obtained by positioning the apparatus 300 and/or image acquisition unit 320 in parallel with the transverse, sagittal, or coronal plane to obtain an image of the vertebra.”; also, para 51, “FIG. 5C illustrates a flow chart 550 of an implementation for indicating a transverse angle, which is an angle with respect to the transverse plane of the vertebra.”), and the second view is a lateral view of the second diagnostic representation of the anatomical structure (para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented.").
Regarding claim 19, Dorman as modified by Peshkin discloses the apparatus of claim 15, wherein Dorman further discloses displaying the first diagnostic representation of the anatomical structure includes displaying the first diagnostic representation of the anatomical structure in a plane that is an axial plane, coronal plane, or a sagittal plane (para 30, “In some embodiments, the image 310 may be obtained by positioning the apparatus 300 and/or image acquisition unit 320 in parallel with the transverse, sagittal, or coronal plane to obtain an image of the vertebra.”; also, para 28, “FIG. 1 illustrates a sagittal or median plane 110, a coronal or frontal plane 120, and a transverse or horizontal plane 130 relative to a patient's body part 100 located at the intersection of the sagittal plane 110, coronal plane 120, and transverse plane 130. Each plane is orthogonal to each other.”; also, para 31, “In some embodiments, the image acquisition unit 320 can be a camera having sufficient field of view 360 to properly align the axis 305 of the apparatus 300 with the desired plane.”), wherein the first diagnostic representation of the anatomical structure is a pictorial view of the anatomical structure, an x-ray of the anatomical structure, a radiograph of the anatomical structure, a computed tomography scan of the anatomical structure, or a magnetic resonance image of the anatomical structure (para 32, “In other embodiments, the image acquisition unit 320 can directly use an image taken from an external machine (not illustrated), such as a radiograph, computed tomography (CT) scanner, or a magnetic resonance imaging (MRI) machine.”).
Regarding claim 20, Dorman discloses a non-transitory computer-readable medium containing instructions (para 25, “It is further noted that, unless indicated otherwise, all functions described herein may be performed in hardware or as software instructions for enabling a computer, radio or other device to perform predetermined operations, where the software instructions are embodied on a computer readable storage medium, such as RAM, a hard drive, flash memory or other type of computer readable storage medium known to a person of ordinary skill in the art.”; also, para 36, “The memory storage unit 352 can be a hard drive, random access memory, solid-state memory, flash memory, or any other storage device. “) that when executed by one or more processors, cause the one or more processors to (para 35, “The processor 350 can be any processing unit capable of basic computation and capable of executing a program, software, firmware, or any application commonly known in the art of computer science.”): display a first movable marker representing an insertion point in an anatomical structure (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635. “) and a first diagnostic representation of the anatomical structure (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”; also, para 59, “FIG. 6A illustrates an interface 600 for selecting vertebra of a patient, FIG. 6B illustrates aligning the axis 305 of the apparatus 300 with the sagittal plane, FIG. 6C illustrates defining a pedicle screw's position and its sagittal angle 370, and FIG. 6D illustrates generating an angle-indicative line 652 for showing the angle between the longitudinal axis of the apparatus and the sagittal plane.”); display a simulated medical device and the first diagnostic representation of the anatomical structure (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”), the simulated medical device in an inserted position at the insertion point (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635."); rotate the simulated medical device about the insertion point (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”) to a first desired position relative to the first diagnostic representation of the anatomical structure (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”; also, para 48, “At 530, definitions of the insertion sagittal angle 370 of the pilot hole 220 and the initial position 375 of the pilot hole are provided by a user.”); display a second movable marker representing the insertion point in the anatomical structure (para 57, “At 585, respective definitions of the insertion angle in the coronal plane 120, and the initial position 375 of the pilot hole are provided by a user, as similar to the sagittal angle defined at 530.”) and a second diagnostic representation of the anatomical structure (para 67, “For example, the apparatus 300 may also use a second or more views to define various angles not limited within the sagittal plane.”; also, para 52, “At 570, the image of the posterior view is captured in the coronal plane.”); display the simulated medical device and the second diagnostic representation of the anatomical structure (para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented.“; also, para 49, “The angle-indicative line can rotate in response to the apparatus 300 rotation and provides a notification when the apparatus 300 approximately forms the insertion sagittal angle 370 between the apparatus 300 longitudinal axis 305 and the sagittal plane.”) in the inserted position at the insertion point (para 59, “In some embodiments, the angle-indicative line may represent a virtual gearshift probe, or other instrument for aligning a pedicle screw or pilot hole.”),rotate the simulated medical device about the insertion point (para 59, “The angle-indicative line can rotate in response to the apparatus 300 rotation and provides a notification when the apparatus 300 approximately forms the insertion coronal angle between the apparatus 300 longitudinal axis 305 and the coronal plane. “) to a second desired position relative to the second diagnostic representation of the anatomical structure (para 48, “At 530, definitions of the insertion sagittal angle 370 of the pilot hole 220 and the initial position 375 of the pilot hole are provided by a user. "); and designate a resultant three-dimensional orientation of the simulated medical device (para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented.”; also, para 9, “The processor is further configured to receive definitions of an insertion sagittal angle, transverse angle, or coronal angle of the tract and an initial position thereof relative to the vertebra, and generate an angle-indicative line on the display, wherein the angle-indicative line rotates in response to rotation of the system, and provides a notification when at least a portion of the system approximately forms the insertion sagittal angle, transverse angle, or coronal angle between an axis of the apparatus and the sagittal plane, transverse plane, or coronal plane of the vertebrae.”) relative to the insertion point as a target orientation (para 45, “Using the electronic device to align the instrument for inserting the surgical hardware installation at the desired orientation through the insertion point includes aligning the electronic device with the instrument at the insertion point 508, tracking movement of the electronic device and the instrument using an orientation sensor of the electronic device until the orientation of the electronic device and the instrument are within the threshold of the simulated orientation 509, and indicating when the electronic device and the instrument are within the threshold of the simulated orientation 511."). Dorman does not disclose wherein the simulated medical device in the second diagnostic representation is constrained to a selection made in the first diagnostic representation.
Howvever, in a similar field of endeavor Peshkin discloses wherein the simulated medical device in the second diagnostic representation is constrained to a selection made in the first diagnostic representation (col 3, “In coordinated fluoroscopy, the geometric projections that relate the two images to a single three-dimensional coordinate system are established before planning commences. The points chosen by the surgeon on two (or more) images can therefore be constrained by the software such that they DO correspond to a well-defined point in three-dimensions. In practice, as a surgeon adjusts an intended point or line segment on one image, the point or line segment displayed on the other image(s) continuously updates and adjusts as well. One cannot draw "arbitrary" points or line segments independently on the images; the software only allows one to draw points or line segments that correspond to a well-defined point or line segment in three-dimensions.”; also, para 8, “The projected guidewire 68 is a line segment which is displayed on the sagittal image area representing the position of the instrumentation to be inserted during the stereotactic surgical procedure. A line of sight 70 is also displayed in the sagittal image area 62.”; also, para 16, “If a cursor is over the A/P image area 86 of FIG. 3a, computer 40 advances to block 476 of FIG. 16A. Computer 40 waits for the trackball to be clicked in the A/P image area 86 as illustrated at block 478.”; also, para 16, “If the A/P and the sagittal images have been registered at block 480, computer 40 determines whether the projected guidewire is drawn as illustrated at block 484. If not, computer 40 assumes that the operator intends to draw the projected guidewire. Therefore, the computer 40 draws a cross hair at trackball coordinate (U,V) as illustrated at block 486. Next, computer 40 draws a curve representing the line of site on the sagittal image using the equations of section [5] of the attached Appendix as illustrated at block 488.”; also, para 18, “If the trackball coordinates are within five pixels of the top point 64 at block 516, computer 40 determines whether the trackball has been clicked again at block 522. If so, computer 40 returns at block 524 to wait for the next command. If not, computer 40 updates the position of the virtual guidewire 68 by moving it along the line of sight in the same direction as the trackball movements.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dorman's invention of software instructions embodied on a computer readable storage medium that cause a processor to simulate the orientation of a pedicle screw about its insertion point, in which the processor displays crosshairs that the user moves to the cortical entry point of the screw on a diagnostic image of the vertebra, displays the screw at that entry point and rotates it to its desired position, uses a second or more views to define angles not limited within the sagittal plane, displays and rotates an instrument for aligning the pedicle screw in that second view, and records the resulting alignment as the simulated orientation against which the instrument is later tracked, with the features of Peshkin's invention of constraining a virtual guidewire displayed on a second image to the point selected on a first image, in which a cross hair placed on the anterior/posterior image produces a line of sight drawn on the sagittal image, the virtual guidewire in the sagittal image is moved along that line of sight, and the software only allows points or line segments to be drawn on the images that correspond to a well-defined point or line segment in three dimensions. The combination would have been obvious because Dorman defines an insertion position and an angle in each of its views and uses those views to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented, and that three-dimensional result exists only if the points defined in the separate views correspond to one point in the bone. Peshkin, working on the same task of planning the insertion of surgical instrumentation on two-dimensional images of a patient, teaches that the points chosen by the surgeon on two images can be constrained by the software such that they correspond to a well-defined point in three dimensions, and implements that constraint by moving the guidewire in the second image along the line of sight of the selection made in the first. A person of ordinary skill implementing Dorman's second view would have applied Peshkin's constraint so that the simulated screw placed on the second diagnostic representation stays tied to the entry point selected on the first, with the predictable result that the two planar definitions yield a single, consistent three-dimensional orientation of the screw.
Claim(s) 4, 7, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dorman (U.S. Pub. No. 2016/0235481) as modified by Peshkin et al. (U.S. Doc. No. 5799055), further in view of Silverstein et al. (U.S. Pub. No. 2020/0237255).
Regarding claim 4, Dorman as modified by Peshkin discloses the method of claim 1, wherein Dorman further comprising: at least on the first desired position of the simulated medical device as superimposed on the first diagnostic representation of the anatomical structure (para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented.”; also, para 48, “At 530, definitions of the insertion sagittal angle 370 of the pilot hole 220 and the initial position 375 of the pilot hole are provided by a user.”) and the second desired position of the simulated medical device as superimposed on the second diagnostic representation of the anatomical structure (para 53, “At 580, definitions of the insertion angle in the transverse plane 130, and the initial position 375 of the pilot hole are provided by a user, as similar to the sagittal angle defined at 530.”; also, para 57, “At 585, respective definitions of the insertion angle in the coronal plane 120, and the initial position 375 of the pilot hole are provided by a user, as similar to the sagittal angle defined at 530.”; also, para 69, “More than one orientation apparatus 330 may be used at the same time to give a three-dimensional viewing. Surgical apparatus may include pedicle screws, gearshift probes, and other medical devices.”). Dorman does not disclose generating the resultant three-dimensional orientation of the simulated medical device.
However, in a similar field of endeavor, Silverstein discloses generating the resultant three-dimensional orientation of the simulated medical device (para 238, “In addition, in combination with information related to the particular structural parameters of the rigid medical device 1514, the processing component 1518 is able to generate information associated with the three dimensional location and orientation of some or all parts of the rigid medical device, such as the distal tip.")
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dorman as modified by Peshkin, in which the simulated screw is positioned and rotated on a first and a second diagnostic representation of the vertebra with the screw in the second representation constrained to the entry point selected in the first, and in which the first and second desired positions of the screw are defined as superimposed on those representations, with the features of Silverstein's invention of generating information associated with the three dimensional location and orientation of a rigid medical device in combination with information related to the particular structural parameters of the device. The combination would have been obvious because Dorman as modified by Peshkin defines the screw's position and angle separately in each view, as the definitions provided by the user at 530, 580 and 585, and Dorman uses those views to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented, which requires that the per-view definitions be converted into one orientation of the device in three dimensions. Silverstein, in the same field of guiding a medical instrument relative to a patient's anatomy, teaches a processing component that, in combination with information related to the particular structural parameters of a rigid medical device, is able to generate information associated with the three dimensional location and orientation of the device. A person of ordinary skill would have used Silverstein's generating step to produce the resultant orientation from the positions defined in the views of Dorman as modified by Peshkin, a predictable use of a known computation for the purpose it already serves.
Regarding claim 7, Dorman as modified by Peshkin discloses the method of claim 6, wherein Dorman discloses rotating the simulated medical device about the insertion point includes rotating the simulated medical device in a first direction in the axial view (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”; also, para 59, “FIG. 6A illustrates an interface 600 for selecting vertebra of a patient, FIG. 6B illustrates aligning the axis 305 of the apparatus 300 with the sagittal plane, FIG. 6C illustrates defining a pedicle screw's position and its sagittal angle 370, and FIG. 6D illustrates generating an angle-indicative line 652 for showing the angle between the longitudinal axis of the apparatus and the sagittal plane. “) and in a second direction in the lateral view (para 59, “The angle-indicative line can rotate in response to the apparatus 300 rotation and provides a notification when the apparatus 300 approximately forms the insertion coronal angle between the apparatus 300 longitudinal axis 305 and the coronal plane"; also, para 54, “At 590, an angle-indicative line for the corresponding transverse angle is generated by a processor and displayed on the display 360.”; also, para 54, “The angle-indicative line can rotate in response to the apparatus 300 rotation and provides a notification when the apparatus 300 approximately forms the insertion transverse angle, as defined in step 580, between the apparatus 300 longitudinal axis 305 and the transverse plane.”; also, para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented.”). Dorman does not disclose the process to generate the three-dimensional orientation of the simulated medical device.
However, in a similar field of endeavor, Silverstein discloses the process to generate the three-dimensional orientation of the simulated medical device (para 238, “In addition, in combination with information related to the particular structural parameters of the rigid medical device 1514, the processing component 1518 is able to generate information associated with the three dimensional location and orientation of some or all parts of the rigid medical device, such as the distal tip.").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dorman as modified by Peshkin, in which the simulated screw is positioned on an axial and a lateral diagnostic representation of the vertebra with the screw in the lateral representation constrained to the entry point selected in the axial one, and in which the screw is rotated in one direction in the axial view and in another direction in the lateral view, with the features of Silverstein's invention of generating information associated with the three dimensional location and orientation of a rigid medical device in combination with information related to the particular structural parameters of the device. The combination would have been obvious because Dorman as modified by Peshkin defines the screw's position and angle separately in each view, as the definitions provided by the user at 530, 580 and 585, and Dorman uses those views to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented, which requires that the per-view definitions be converted into one orientation of the device in three dimensions. Silverstein, in the same field of guiding a medical instrument relative to a patient's anatomy, teaches a processing component that, in combination with information related to the particular structural parameters of a rigid medical device, is able to generate information associated with the three dimensional location and orientation of the device. A person of ordinary skill would have used Silverstein's generating step to produce the resultant orientation from the positions defined in the views of Dorman as modified by Peshkin, a predictable use of a known computation for the purpose it already serves.
Regarding to claim 17, Dorman as modified by Peshkin discloses the apparatus of claim 16, wherein Dorman further discloses rotating the simulated medical device about the insertion point includes rotating the simulated medical device from left to right in the axial view (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635. “; also, para 49, “The angle-indicative line can rotate in response to the apparatus 300 rotation and provides a notification when the apparatus 300 approximately forms the insertion sagittal angle 370 between the apparatus 300 longitudinal axis 305 and the sagittal plane.”) and left to right in the lateral view (para 39, “In the embodiment shown in FIG. 3B, the sagittal angle 370 is the angle between the central axis 365 of the pilot hole 220 and the sagittal plane.”). Dorman does not disclose the ability to generate the three-dimensional orientation of the simulated medical device.
However, in a similar field of endeavor, Silverstein discloses the ability to generate the three-dimensional orientation of the simulated medical device (para 238, “In addition, in combination with information related to the particular structural parameters of the rigid medical device 1514, the processing component 1518 is able to generate information associated with the three dimensional location and orientation of some or all parts of the rigid medical device, such as the distal tip.").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dorman as modified by Peshkin, in which the simulated screw is positioned on an axial and a lateral diagnostic representation of the vertebra with the screw in the lateral representation constrained to the entry point selected in the axial one, and in which the screw is rotated from left to right in the axial view and from left to right in the lateral view, with the features of Silverstein's invention of generating information associated with the three dimensional location and orientation of a rigid medical device in combination with information related to the particular structural parameters of the device. The combination would have been obvious because Dorman as modified by Peshkin defines the screw's position and angle separately in each view, as the definitions provided by the user at 530, 580 and 585, and Dorman uses those views to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented, which requires that the per-view definitions be converted into one orientation of the device in three dimensions. Silverstein, in the same field of guiding a medical instrument relative to a patient's anatomy, teaches a processing component that, in combination with information related to the particular structural parameters of a rigid medical device, is able to generate information associated with the three dimensional location and orientation of the device. A person of ordinary skill would have used Silverstein's generating step to produce the resultant orientation from the positions defined in the views of Dorman as modified by Peshkin, a predictable use of a known computation for the purpose it already serves.
Claim(s) 8 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dorman (U.S. Pub. No. 2016/0235481) as modified by Peshkin et al. (U.S. Doc. No. 5799055), further in view of Lang (U.S. Pub. No. 2020/0305980).
Regarding claim 8, Dorman as modified by Peshkin discloses the method of claim 5, wherein Dorman further comprising display visual indicia indicating the desired insertion point (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”; also para 64, “Tap the Nav button 644 and a virtual gearshift probe 652 appears on the screen.”) and the three-dimensional orientation of the simulated medical device shown at the three-dimensional orientation of the simulated medical device in relation to the desired insertion point (para 59, “In some embodiments, the angle-indicative line may represent a virtual gearshift probe, or other instrument for aligning a pedicle screw or pilot hole."; also, para 64, “In some embodiments, once the angle of the gearshift probe 652 is about 20 degrees within the selected trajectory, the gearshift probe 652 will turn yellow, at 5 degrees, it will turn green, and when the alignment is within 1 degree of the target angle, a green line 654 will extend outward and the pedicle screw will disappear.”; also, para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented.”). Dorman does not disclose using an augmented reality based electronic device.
However, in a similar field of endeavor, Lang discloses using an augmented reality based electronic device (para 102, “The Microsoft HoloLens is manufactured by Microsoft. It is a pair of augmented reality smart glasses."; also, para 4, “Aspects of the invention provides, among other things, for a simultaneous visualization of live data of the patient, e.g. a patient's spine or joint, and digital representations of virtual data such as virtual cuts and/or virtual surgical guides including cut blocks or drilling guides through an optical head mounted display (OHMD).”; also, para 247, “The virtual data can also include a medical device, such as a pedicle screw, wherein the virtual data of the pedicle screw shows its intended location, orientation or path in relationship to the spine, and/or a pedicle, and/or a vertebral body.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dorman as modified by Peshkin, in which the simulated screw is positioned and rotated in a first view and a second view at a known angle to one another, with the screw in the second view constrained to the entry point selected in the first and the resultant three-dimensional orientation determined from the known angle, and in which visual indicia of the insertion point and of the orientation are displayed, with the features of Lang's invention of an augmented reality based electronic device, the Microsoft HoloLens augmented reality smart glasses, through which virtual data of a pedicle screw showing its intended location, orientation or path in relationship to the spine is displayed. The combination would have been obvious because Dorman displays the crosshairs at the screw's entry point, the screw at its desired position, and a virtual gearshift probe on the screen of the apparatus, and Lang, in the same field of guiding the placement of pedicle screws, teaches displaying the same kind of virtual pedicle screw data, with its intended location, orientation or path, through an optical head mounted display that visualizes the virtual data simultaneously with live data of the patient's spine. A person of ordinary skill would have displayed the planned insertion point and three-dimensional orientation of Dorman as modified by Peshkin on Lang's augmented reality device so that the surgeon sees the plan together with the patient's anatomy, a predictable use of a known display for the purpose Lang describes.
Regarding claim 18, Dorman as modified by Peshkin discloses the apparatus of claim 15, wherein Dorman further discloses the one or more processors further configured to (para 35, “In some embodiments, the apparatus 300 further includes a processor 350.”; also, para 35, “The processor 350 can be any processing unit capable of basic computation and capable of executing a program, software, firmware, or any application commonly known in the art of computer science.”) display visual indicia indicating the insertion point (para 63, “The user next selects the optimal pedicle screw position by selecting the navigation button 644 and by moving the crosshairs 633 to the cortical entry point of the screw, then tapping the trajectory button 634 and rotate the screw to its desired position 635.”; also, para 64, “Tap the Nav button 644 and a virtual gearshift probe 652 appears on the screen.”) and the three-dimensional orientation of the simulated medical device shown at the three-dimensional orientation of the simulated medical device in relation to the desired insertion point (para 59, “In some embodiments, the angle-indicative line may represent a virtual gearshift probe, or other instrument for aligning a pedicle screw or pilot hole. "; also, para 64, “In some embodiments, once the angle of the gearshift probe 652 is about 20 degrees within the selected trajectory, the gearshift probe 652 will turn yellow, at 5 degrees, it will turn green, and when the alignment is within 1 degree of the target angle, a green line 654 will extend outward and the pedicle screw will disappear.”; also, para 67, “For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented.”). Dorman does not disclose use an augmented reality based electronic device.
However, in a similar field of endeavor, Lang discloses use an augmented reality based electronic device (para 102, “The Microsoft HoloLens is manufactured by Microsoft. It is a pair of augmented reality smart glasses.”; also, para 4, “Aspects of the invention provides, among other things, for a simultaneous visualization of live data of the patient, e.g. a patient's spine or joint, and digital representations of virtual data such as virtual cuts and/or virtual surgical guides including cut blocks or drilling guides through an optical head mounted display (OHMD).”; also, para 247, “The virtual data can also include a medical device, such as a pedicle screw, wherein the virtual data of the pedicle screw shows its intended location, orientation or path in relationship to the spine, and/or a pedicle, and/or a vertebral body.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Dorman as modified by Peshkin, in which the processors of the apparatus position and rotate the simulated screw in a first view and a second view at a known angle to one another, with the screw in the second view constrained to the entry point selected in the first and the resultant three-dimensional orientation determined from the known angle, and in which visual indicia of the insertion point and of the orientation are displayed, with the features of Lang's invention of an augmented reality based electronic device, the Microsoft HoloLens augmented reality smart glasses, through which virtual data of a pedicle screw showing its intended location, orientation or path in relationship to the spine is displayed. The combination would have been obvious because Dorman displays the crosshairs at the screw's entry point, the screw at its desired position, and a virtual gearshift probe on the screen of the apparatus, and Lang, in the same field of guiding the placement of pedicle screws, teaches displaying the same kind of virtual pedicle screw data, with its intended location, orientation or path, through an optical head mounted display that visualizes the virtual data simultaneously with live data of the patient's spine. A person of ordinary skill would have displayed the planned insertion point and three-dimensional orientation of Dorman as modified by Peshkin on Lang's augmented reality device so that the surgeon sees the plan together with the patient's anatomy, a predictable use of a known display for the purpose Lang describes.
Response to Arguments
Applicants arguments filed 09/08/2026 has been fully considered.
On page 8 of the Applicant's Remarks, with respect to the rejection of claims 1, 14, and 20 under 35 U.S.C. 102(a)(1) over Dorman, the Applicant argues that "independent claims 1, 14, and 20 are amended, thereby rendering the rejection moot", that "the cited references fails to disclose, teach, or suggest each and every element of claims 1, 14, and 20," and that "The rejection under 35 U.S.C. § 102 does not apply to the amended claims." The argument is persuasive only to the extent that Dorman alone is not relied upon for the clause the amendment adds, "wherein the simulated medical device in the second diagnostic representation is constrained to a selection made in the first diagnostic representation," and the rejection of claims 1-3, 5, 6, 9-16, 19, and 20 under 35 U.S.C. 102(a)(1) has therefore been withdrawn; however, upon further consideration and as necessitated by Applicant's amendment, a new ground of rejection under 35 U.S.C. 103 over Dorman as modified by Peshkin is made as set forth above. Every other limitation of claims 1, 14, and 20 was recited in the claims as examined and was found in Dorman in the Office action of March 5, 2026, including at paragraphs [0048], [0059], [0063], and [0067]; the amendment leaves that language unchanged, and the Remarks do not point out any of it that Dorman fails to teach or explain how the language of the claims patentably distinguishes them from the references, as 37 CFR 1.111(b) requires, so that finding is maintained. As shown in the citations, Peshkin discloses that "The points chosen by the surgeon on two (or more) images can therefore be constrained by the software such that they DO correspond to a well-defined point in three-dimensions." (Peshkin, col. 3), that "Computer 40 waits for the trackball to be clicked in the A/P image area 86 as illustrated at block 478." (Peshkin, col. 16), that "Therefore, the computer 40 draws a cross hair at trackball coordinate (U,V) as illustrated at block 486." (Peshkin, col. 16) and "Next, computer 40 draws a curve representing the line of site on the sagittal image using the equations of section [5] of the attached Appendix as illustrated at block 488." (Peshkin, col. 16), that "The projected guidewire 68 is a line segment which is displayed on the sagittal image area representing the position of the instrumentation to be inserted during the stereotactic surgical procedure." (Peshkin, col. 8), and that "If not, computer 40 updates the position of the virtual guidewire 68 by moving it along the line of sight in the same direction as the trackball movements." (Peshkin, col. 18). The cross hair placed on the A/P image is a selection made in the first diagnostic representation, and the virtual guidewire displayed on the sagittal image, which represents the instrumentation to be inserted, is moved along the line of sight that selection defines, so the simulated device in the second diagnostic representation is constrained to a selection made in the first.
On pages 8 and 9 of the Applicant's Remarks, with respect to the rejection of claims 2-13 and 15-19, including the rejections of claims 4, 7, and 17 over Dorman as modified by Silverstein and of claims 8 and 18 over Dorman as modified by Lang under 35 U.S.C. 103, the Applicant argues that "Since Claims 2-13 and 15-19 depend from the patentable subject matter of claims 1 and 14, respectively, claims 4, 7, 8, 17, and 18 are patentable and in condition for allowance." The argument is not persuasive. It rests entirely on the patentability of claims 1 and 14, which are rejected above over Dorman as modified by Peshkin, and the Applicant presents no separate argument directed to any limitation that a dependent claim adds.
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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/JAI W LI/Junior Patent Examiner, Art Unit 2613
/XIAO M WU/Supervisory Patent Examiner, Art Unit 2613
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