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
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Hoehne et al (EP 1897061), hereinafter Hoehne, in view of Veronesi et al (US 20180344290), hereinafter Veronesi.
Regarding claim 1, Hoehne teaches a method (Abstract) by a navigated surgery system (“The invention relates to an apparatus and a method for displaying 2D tomograms of internal structures. The invention enables the 3D representation of the physical extent of a tool in 2D tomograms of internal structures and the representation of changes to the internal structures.”; in: Description, p. 1. “The electronic input unit may be a navigation system, which locates the real tool and detected in its movement and possibly size,”; p. 3, 6th para.; “The surgeon sees on the screen, especially on the 2D layers, his tool in its spatial expression in relation to the anatomy”; p. 3, the last para.; “the tool … is detected and described in its three-dimensional properties.” p. 4, 4th para), the method comprising:
obtaining a three-dimensional (3D) graphical model of an internal anatomical structure of a patient (“simultaneously with computer-generated visualized three-dimensional (3D) models” in: Description, p. 1.);
tracking a tip of a surgical tool (2) relative to the 3D graphical model (“The invention enables the 3D representation of the physical extent of a tool in 2D tomograms of internal structures and the representation of changes to the internal structures…to represent the progress of a material-removing operation, the action of the surgical tool, the three-dimensional arrangement of the surgical tool relative to a or more 2D slices”; in: Description, pp. 1-2; “the real position of the tip of the tool is mapped to the computer model”; p. 2, 5th para.; “the removed region as well as the tool in its three-dimensional position and orientation should be displayed in real time on the layer images in order to map the course and the effect of the surgical tool in space and time”; p. 2, 6th para.; “Fig. 2 shows two pictures. Specifically, a transversal slice image (right) and a 3D model are shown and visualized from the data volume. The modified region in terms of drill size and movement is marked in the 3D solid model and also displayed on the 2D cross-sectional image, as well as a three-dimensional image of the drilling tool (2).” p. 4, the second to last para.);
selecting, based on a pose of the tracked surgical tool tip (“the tool as a 3D object… including its 3D orientation”; p. 3, 1st para.), a first two-dimensional (2D) image slice (“the 2D slice”; “transversal” p. 4, the second to last para.) of a portion of the internal anatomical structure (“(a) generating a tool as a 3D computer simulation and mapping the tool as a 3D object in the 2D slice including its 3D orientation with respect to the 2D slice image” p. 3, 1st para) from a plurality of 2D image slices of the internal anatomical structure (“the 2D slice images of internal structures”) (“the three-dimensional arrangement of the surgical tool relative to a or more 2D slices”; in: Description, pp. 1-2; “a method for displaying 2D slice images of internal structures comprising the representation in the 2D slice images the physical extent of a 3D tool and its movement in the internal structures and / or changes in one or more internal structures due to the action of the tool, preferably both”; p. 2, the third to last para.“(11) Representation of the tool as a 3D object shaded by methods of computer graphics in its spatial relationship to the 2D slice image.”; p. 5, 2nd para.);
selecting, based on the pose of the tracked surgical tool tip, a second 2D image slice of the portion of the internal anatomical structure (“sagittal, or coronal” p. 5, 2nd para.) from the plurality of 2D image slices of the internal anatomical structure, wherein the second 2D image slice is perpendicular to the first 2D image slice (“(10) Extraction of 2D slice images from the 3D volume, preferably in the direction of at least one body axis (transversal, sagittal, or coronal), through the center of the work surface, or free choice.” p. 5, 2nd para.) and the tip of the tracked surgical tool is positioned at an intersection of the first 2D image slice and the second 2D image slice (“the illustrated 2D slices intersect the active area of the tool and follow its movement, the illustrated 2D slice images of arbitrary position and orientation are extracted from the 3D model with a representation of a representative for the tool or its position, and the method further comprises at least the following steps selected from the group”; p. 2, the last para.. Note that “transversal, sagittal, or coronal” 2D slice images intersect and each of them intersects the active area of the tool in the center of the slice as seen in Fig. 2. Therefore, the tip of the tracked surgical tool is positioned at an intersection as claimed).
Hoehne does not teach displaying the first 2D image slice and the second 2D image slice as overlays on the 3D graphical model of the internal anatomical structure of the patient.
However, in the medical imaging field of endeavor, Veronesi discloses systems and methods for displaying intersections on ultrasound images, which is analogous art. Veronesi teaches displaying the first 2D image slice (330) and the second 2D image slice (350) as overlays on the 3D graphical model (320) of the internal anatomical structure of the patient (“The first 2D slice 330 and the second 2D slice 350 may comprise different 2D views of the 3D ultrasound dataset. The intersections between the 2D slices 330 and 350 with the 3D image volume 305 may be visually depicted in the 3D mesh model 320. For example, the plane corresponding to the first 2D slice 330 may be represented as a line or intersection 335 on the 3D mesh model 320, while the plane corresponding to the second 2D slice 350 may be represented as a line or intersection 355 on the 3D mesh model 320. The intersections 335 and 355 may also be displayed or overlaid on the 3D image volume 305.” [0043]; Figs. 2-3).
Therefore, based on Veronesi’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the invention of Hoehne to display the first 2D image slice and the second 2D image slice as overlays on the 3D graphical model of the internal anatomical structure of the patient, as taught by Veronesi, in order to assist the surgeon in performing the surgical procedure.
Regarding claim 2, Hoehne modified by Veronesi teaches the method of claim 1, wherein Hoehne teaches selecting the first 2D image slice comprises dynamically selecting (“real time” p. 2, 4th to last para.) the first 2D image slice based on movement of the tracked surgical tool tip (“The modified region in terms of drill size and movement”; p. 4 the 2nd to last para.), and selecting the second 2D image slice comprises dynamically selecting the second 2D image slice (“the three-dimensional arrangement of the surgical tool relative to … more 2D slices” Description, pp. 1-2) based on movement of the tracked surgical tool (“The modified region in terms of drill size and movement” p. 4 the 2nd to last para.) (“the real position of the tip of the tool is mapped to the computer model”; p. 2, 5th para. “The invention enables the 3D representation of the physical extent of a tool in 2D tomograms of internal structures and the representation of changes to the internal structures…to represent the progress of a material-removing operation, the action of the surgical tool, the three-dimensional arrangement of the surgical tool relative to a or more 2D slices” Description, pp. 1-2; “the removed region as well as the tool in its three-dimensional position and orientation should be displayed in real time on the layer images in order to map the course and the effect of the surgical tool in space and time” p. 2, 4th to last para.; “Fig. 2 shows two pictures. Specifically, a transversal slice image (right) and a 3D model are shown and visualized from the data volume. The modified region in terms of drill size and movement is marked in the 3D solid model and also displayed on the 2D cross-sectional image, as well as a three-dimensional image of the drilling tool (2).” p. 4, 2nd to last para.).
Regarding claim 3, Hoehne modified by Veronesi teaches the method of claim 1, wherein Hoehne teaches that the first 2D image slice is an axial 2D image slice (“transversal” p. 5, 2nd para.).
Regarding claim 4, Hoehne modified by Veronesi teaches the method of claim 1, wherein Hoehne teaches that the second 2D image slice is a sagittal 2D image slice (“Such models are e.g. used for navigational support during a real operation. Here, the real position of the tip of the tool is mapped to the computer model by known methods, so that e.g. the corresponding sagittal, coronal and transverse layers passing through this point are shown.”; p. 2, 5th para.; “(10) Extraction of 2D slice images from the 3D volume, preferably in the direction of at least one body axis (transversal, sagittal, or coronal), through the center of the work surface, or free choice.” p. 5, 2nd para.).
Regarding claim 5, Hoehne modified by Veronesi teaches the method of claim 1, wherein Hoehne teaches that the plurality of 2D image slices of the internal anatomical structure together form a 3D volume of the internal anatomical structure (“Since only two-dimensional slice images are accessible from conventional imaging techniques, surgeons must derive the actual three-dimensional location and shape of desired internal structures from the 2D images they view. As a result, 3D models have been developed that show the internal structures and in particular the organs of the surgical field. The fact that 3D models can be generated from 2D slice images obtained by medical recording methods is described”; p. 2, 4th para.; “(2) From the layer images, an image volume (that is, 3D matrix) is generated consisting of, for example, 512 × 512 × 256 addressable volume elements (voxels), each of which is provided with intensity values (typically scale 0-4095).”; p. 4, the last para. – p. 5, 1st para.).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hoehne in view of Veronesi as applied to claim 1, and further in view of Foley et al (US20050085714), hereinafter Foley.
Regarding claim 6, Hoehne modified by Veronesi teaches the method of claim 1.
Hoehne modified by Veronesi does not teach that the internal anatomical structure is the patient's spine.
However, in the surgical navigation field of endeavor, Foley discloses a method and apparatus for surgical navigation of a multiple piece construct for implantation, which is analogous art. Foley teaches that the internal anatomical structure is the patient's spine (200) (“For example, multiple image data of the patient's spine may be appended together to provide a full view or complete set of image data of the spine that may be used at a selected time. These images are then forwarded from the fluoroscopic device controller 60 to the controller, navigation computer or work station 24 having the display 28 and the user interface 44.” [0056]; Fig. 1; “(111) The first virtual screw 206' and the second virtual screw 220' may be shown alone on the screen 210 or may be shown in conjunction with an image of the spine 200. The image of the spine may be an image acquired pre- or intra-operatively of the patient 40.” [0126]; Fig. 13A).
Therefore, based on Foley’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the invention of Hoehne and Veronesi to have the internal anatomical structure that is the patient's spine, as taught by Foley, in order to assist the surgeon in performing the surgical procedure on the spine.
Claims 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hoehne et al (EP 1897061), hereinafter Hoehne, in view of Foley et al (US20050085714), hereinafter Foley.
Regarding claim 7, Hoehne teaches a method (Abstract) by a navigated surgery system (“The invention relates to an apparatus and a method for displaying 2D tomograms of internal structures. The invention enables the 3D representation of the physical extent of a tool in 2D tomograms of internal structures and the representation of changes to the internal structures.”; in: Description, p. 1. “The electronic input unit may be a navigation system, which locates the real tool and detected in its movement and possibly size,”; p. 3, 6th para.; “The surgeon sees on the screen, especially on the 2D layers, his tool in its spatial expression in relation to the anatomy”; p. 3, the last para.; “the tool … is detected and described in its three-dimensional properties.” p. 4, 4th para), the method comprising:
obtaining a three-dimensional (3D) graphical model of an internal anatomical structure of a patient (“simultaneously with computer-generated visualized three-dimensional (3D) models” in: Description, p. 1.);
tracking a tip of a surgical tool (2) relative to the 3D graphical model (“The invention enables the 3D representation of the physical extent of a tool in 2D tomograms of internal structures and the representation of changes to the internal structures…to represent the progress of a material-removing operation, the action of the surgical tool, the three-dimensional arrangement of the surgical tool relative to a or more 2D slices”; in: Description, pp. 1-2; “the real position of the tip of the tool is mapped to the computer model”; p. 2, 5th para.; “the removed region as well as the tool in its three-dimensional position and orientation should be displayed in real time on the layer images in order to map the course and the effect of the surgical tool in space and time”; p. 2, 6th para.; “Fig. 2 shows two pictures. Specifically, a transversal slice image (right) and a 3D model are shown and visualized from the data volume. The modified region in terms of drill size and movement is marked in the 3D solid model and also displayed on the 2D cross-sectional image, as well as a three-dimensional image of the drilling tool (2).” p. 4, the second to last para.);
selecting, based on a pose of the tracked surgical tool tip (“the tool as a 3D object… including its 3D orientation”; p. 3, 1st para.), a first two-dimensional (2D) image slice (“the 2D slice”; “transversal” p. 4, the second to last para.) of a portion of the internal anatomical structure (“(a) generating a tool as a 3D computer simulation and mapping the tool as a 3D object in the 2D slice including its 3D orientation with respect to the 2D slice image” p. 3, 1st para) from a plurality of 2D image slices of the internal anatomical structure (“the 2D slice images of internal structures”) (“the three-dimensional arrangement of the surgical tool relative to a or more 2D slices”; in: Description, pp. 1-2; “a method for displaying 2D slice images of internal structures comprising the representation in the 2D slice images the physical extent of a 3D tool and its movement in the internal structures and / or changes in one or more internal structures due to the action of the tool, preferably both”; p. 2, the third to last para.“(11) Representation of the tool as a 3D object shaded by methods of computer graphics in its spatial relationship to the 2D slice image.”; p. 5, 2nd para.);
selecting, based on the pose of the tracked surgical tool tip, a second 2D image slice of the portion of the internal anatomical structure (“sagittal, or coronal” p. 5, 2nd para.) from the plurality of 2D image slices of the internal anatomical structure, wherein the second 2D image slice is perpendicular to the first 2D image slice (“(10) Extraction of 2D slice images from the 3D volume, preferably in the direction of at least one body axis (transversal, sagittal, or coronal), through the center of the work surface, or free choice.” p. 5, 2nd para.) and the tip of the tracked surgical tool is positioned at an intersection of the first 2D image slice and the second 2D image slice (“the illustrated 2D slices intersect the active area of the tool and follow its movement, the illustrated 2D slice images of arbitrary position and orientation are extracted from the 3D model with a representation of a representative for the tool or its position, and the method further comprises at least the following steps selected from the group”; p. 2, the last para.. Note that “transversal, sagittal, or coronal” 2D slice images intersect and each of them intersects the active area of the tool in the center of the slice as seen in Fig. 2. Therefore, the tip of the tracked surgical tool is positioned at an intersection as claimed).
Hoehne does not teach displaying the first 2D image slice and the second 2D image slice as overlays on the patient through a see-through screen of a head mounted display.
However, in the surgical navigation field of endeavor, Foley discloses a method and apparatus for surgical navigation of a multiple piece construct for implantation, which is analogous art. Foley teaches displaying the first 2D image slice and the second 2D image slice as overlays on the patient (40) through a see-through screen of a head mounted display (“The monitor 28 may be any appropriate monitor and may also include a heads-up or head mounted display.” [0044] “It should further be noted that the fluoroscopic imaging device 50, as shown in FIG. 1, provides a virtual bi-plane image using a single-head C-arm fluoroscope 50 by simply rotating the C-arm 52 about at least two planes, which could be orthogonal planes to generate two-dimensional images that can be converted to three-dimensional volumetric images. By acquiring images in more than one plane, an icon representing the location of an instrument or lead, introduced and advanced in the patient 40, may be superimposed in more than one view on display 28 allowing simulated bi-plane or even multi-plane views, including two and three-dimensional views,”; [0063]; Fig. 1).
Therefore, based on Foley’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the invention of Hoehne to display the first 2D image slice and the second 2D image slice as overlays on the patient through a see-through screen of a head mounted display, as taught by Foley, in order to assist the surgeon in performing the surgical procedure.
Regarding claim 8, Hoehne modified by Foley teaches the method of claim 7, wherein Hoehne teaches selecting the first 2D image slice comprises dynamically selecting (“real time” p. 2, 4th to last para.) the first 2D image slice based on movement of the tracked surgical tool tip (“The modified region in terms of drill size and movement”; p. 4 the 2nd to last para.), and selecting the second 2D image slice comprises dynamically selecting the second 2D image slice (“the three-dimensional arrangement of the surgical tool relative to … more 2D slices” Description, pp. 1-2) based on movement of the tracked surgical tool (“The modified region in terms of drill size and movement” p. 4 the 2nd to last para.) (“the real position of the tip of the tool is mapped to the computer model”; p. 2, 5th para. “The invention enables the 3D representation of the physical extent of a tool in 2D tomograms of internal structures and the representation of changes to the internal structures…to represent the progress of a material-removing operation, the action of the surgical tool, the three-dimensional arrangement of the surgical tool relative to a or more 2D slices” Description, pp. 1-2; “the removed region as well as the tool in its three-dimensional position and orientation should be displayed in real time on the layer images in order to map the course and the effect of the surgical tool in space and time” p. 2, 4th to last para.; “Fig. 2 shows two pictures. Specifically, a transversal slice image (right) and a 3D model are shown and visualized from the data volume. The modified region in terms of drill size and movement is marked in the 3D solid model and also displayed on the 2D cross-sectional image, as well as a three-dimensional image of the drilling tool (2).” p. 4, 2nd to last para.).
Regarding claim 9, Hoehne modified by Foley teaches the method of claim 7, wherein Hoehne teaches that the first 2D image slice is an axial 2D image slice (“transversal” p. 5, 2nd para.).
Regarding claim 10, Hoehne modified by Foley teaches the method of claim 7, wherein Hoehne teaches that the second 2D image slice is a sagittal 2D image slice (“Such models are e.g. used for navigational support during a real operation. Here, the real position of the tip of the tool is mapped to the computer model by known methods, so that e.g. the corresponding sagittal, coronal and transverse layers passing through this point are shown.”; p. 2, 5th para.; “(10) Extraction of 2D slice images from the 3D volume, preferably in the direction of at least one body axis (transversal, sagittal, or coronal), through the center of the work surface, or free choice.” p. 5, 2nd para.).
Regarding claim 11, Hoehne modified by Foley teaches the method of claim 7, wherein Hoehne teaches that the plurality of 2D image slices of the internal anatomical structure together form a 3D volume of the internal anatomical structure (“Since only two-dimensional slice images are accessible from conventional imaging techniques, surgeons must derive the actual three-dimensional location and shape of desired internal structures from the 2D images they view. As a result, 3D models have been developed that show the internal structures and in particular the organs of the surgical field. The fact that 3D models can be generated from 2D slice images obtained by medical recording methods is described”; p. 2, 4th para.; “(2) From the layer images, an image volume (that is, 3D matrix) is generated consisting of, for example, 512 × 512 × 256 addressable volume elements (voxels), each of which is provided with intensity values (typically scale 0-4095).”; p. 4, the last para. – p. 5, 1st para.).
Regarding claim 12, Hoehne modified by Foley teaches the method of claim 7.
Hoehne does not teach that the internal anatomical structure is the patient's spine.
However, in the surgical navigation field of endeavor, Foley discloses a method and apparatus for surgical navigation of a multiple piece construct for implantation, which is analogous art. Foley teaches that the internal anatomical structure is the patient's spine (200) (“For example, multiple image data of the patient's spine may be appended together to provide a full view or complete set of image data of the spine that may be used at a selected time. These images are then forwarded from the fluoroscopic device controller 60 to the controller, navigation computer or work station 24 having the display 28 and the user interface 44.” [0056]; Fig. 1; “(111) The first virtual screw 206' and the second virtual screw 220' may be shown alone on the screen 210 or may be shown in conjunction with an image of the spine 200. The image of the spine may be an image acquired pre- or intra-operatively of the patient 40.” [0126]; Fig. 13A).
Therefore, based on Foley’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the invention of Hoehne to have the internal anatomical structure that is the patient's spine, as taught by Foley, in order to assist the surgeon in performing the surgical procedure on the spine.
Conclusion
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/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798