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 .
Status of Claims
Claims 1-20 are pending in this application. Claims 3 and 18 are withdrawn, Claim 4 is cancelled, and 1, 2, 5-17, and 19-20 have been examined on the merits.
Drawings
The drawings were received on 02/19/2026. These drawings are Acceptable.
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.
Claims 1-2, 5-11, 13-14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kou (WO2020205714A1, disclosed in Applicant IDS) in view of Phillips (Anonymous: "Classic Planning Pinnacle 3 Instructions for Use", , 1 June 2018 (2018-06-01), pages 1-344, XP055902089, disclosed in Applicant IDS).
Regarding Claim 1,
Kou teaches a computer implemented method for processing images comprising the following steps:
a) obtaining a 3D image of a region of interest, the region of interest including an anatomical region of a patient (corresponding disclosure in at least [0059], where the 3D image includes an ROI of the anatomy (the brain) “first stereoscopic image 14 provided whiter matter fiber tracking of brain and spinal cord tissue. A first stereoscopic image 14 is rendered on a display 12 from the image data. The first stereoscopic image includes image parallax in order to provide the 3D rendering”);
b) obtaining at least one projection of the region of interest , the projection of the region of interest being a 2D overall image of the region of interest and showing information of a first type about the region of interest according to a point of view (corresponding disclosure in at least Figure 4A and [0074], where the projection alone is a 2D slice (as seen in Figure 4A), showing the ROI, and the combination of the slices comprises the 3D image “When the stereoscopic image (i.e., in 3D space) changes, the corresponding slice of 2D will also update dynamically and reflect the changes. Vice versa, when one or more than one 2D slice change, the corresponding 3D image will also be updated dynamically and reflect the changes”)
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Figure 4A of Kou
the 2D overall image corresponding to the at least one projection projecting the 3D image of the region of interest according to the point of view onto a 2D plane (corresponding disclosure in at least [0066], where there is a projection projecting the 3D image of the region of interest according to the 2D plane “When the thickness of the rectangular box is reduced to a thin slice or a plane, only those fibers with their main orientation crossing the slice will be displayed. This rectangular box could also be a slab or a slice of an anatomical structure. By adjusting the orientation of the slice or plane, the user could select different fiber orientations”; the rectangle box is reduced to a slice/plane, which is interpreted as the 2D projection and further in [0079], where the image is radiographic “The image data can include CT, MRI, PET, mammography, ultrasound, or photoacoustic image data”).
c) obtaining at least one slice from the 3D image, the slice comprising a point of interest in the region of interest, the obtained slice containing information about the region of interest of a second type around the point of interest (corresponding disclosure in at least [0059] and Figure 4A, where there is at least a slice from the 3D image shown which is taken, and a point of interest information (the white matter fiber) is contained “first stereoscopic image 14 provided whiter matter fiber tracking of brain and spinal cord tissue. A first stereoscopic image 14 is rendered on a display 12 from the image data”)
d) computing a composite 2D image wherein a portion of one of the 2D overall image containing information about the point of interest is replaced by the projection of a corresponding portion of the obtained slice from the same point of view so that information of the second type is accurately arranged relatively to information of the first type present in the 2D overall image (corresponding disclosure in at least [0066] and Figure 5B, where there is a thin slice (composite 2D image) with the information of the point of interest with accurately arranged information (the main orientation) being provided “the application of container 60 selectively highlights fibers 62 that pass this rectangular box. When the thickness of the rectangular box is reduced to a thin slice or a plane, only those fibers with their main orientation crossing the slice will be displayed. This rectangular box could also be a slab or a slice of an anatomical structure. By adjusting the orientation of the slice or plane, the user could select different fiber orientations”),
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Figure 5B of Kou
wherein the method comprises a step of tracking a medical instrument into the region of interest, the instrument extending along a main axis, the obtained slice being a slice of the region of interest wherein the medical instrument extends (corresponding disclosure in at least [0097], where there is a medical instrument (stylus) which is tracked into the ROI (the fiber) “fiber tracking using a stylus is depicted the local transformation of the physical stylus is always tracked by two cameras, the data can be retrieved by tracking the location of the stylus. The stylus has markers that can be identified by the cameras in infrared light”, and further in [0097] and further in detail in [0097] – [0114], where there is a localized center (main axis) where the slice can be obtained based on the stylus (medical instrument), and the details further describing the steps “ Localize the center of image acquisition of the organ, which will also be used as the center of orthoslicer. This will be the starting poit of x, y, z coordinates. b. Render slices to xz-plane, xy-plane, and yz-plane based on the coordinate of center”).
Kou does not teach the at least one projection comprising at least radiographic image obtained from a medical imaging device.
Phillips, in a similar field of endeavor, teaches a similar concept (viewing of medical images) of at least one projection comprising at least radiographic image obtained from a medical imaging device (corresponding disclosure in at least [pg. 53, “Beam relative views”], where a 2D projection view of a CT image is available “you can quickly locate a projection that is sagittal or coronal to the central axis of the supra clavicular or head fields, then manipulate the gantry collimator or couch of an alternate beam to correctly match the divergence to a fixed beam… Select the beam axial slice of the medial tangent field, then turn on the display for the lateral beam on the 2D BRV axial slice of the medial beam”)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated a projection comprising a radiographic image from a medical imaging device as taught by Phillips. One of the ordinary skill in the art would have been motivated to incorporate this because the medical image provides further information regarding the anatomical structures to further adjust the composite image.
Regarding Claim 2, Kou and Phillips teach the limitations of Claim 1 and Kou further teaches wherein the slice is oriented along a plane orthogonal to a direction of the projection (corresponding disclosure in at least [0113], where a slice obtained is orthogonal to the plane “Use 2D image slices in 3D orthogonal plane (orthoslicer) as reference plane for fiber tracking”).
Regarding Claim 5, Kou and Phillips teach the limitations of Claim 1 and Kou further teaches wherein the slice passes through the main axis of the medical instrument,
wherein the 3D image is associated with a reference frame comprising three cartesian axes X, Y, Z and wherein the slice passes through one of these cartesian axes (corresponding disclosure in at least [0064] and Figure 5A and 5B, where the 3D image passes through one of the axes corresponding to the medical instrument (the tracking container) “White matter tracts and/or fibers 62 passing through three-dimensional tracking container 601 are highlighted…. three-dimensional tracking container 60 moves in response to user input (e.g., from pointing device 30) such that highlighted fibers that pass through the container are updated dynamically as the three-dimensional tracking container moves”),
such that the slice contains the instrument main axis and has a direction parallel to the chosen cartesian axis (corresponding disclosure in at least [0064] and Figure 5B, where the slice is based on the direction the instrument main axis, so the slice is a direction parallel to the axis “. A user initiates with pointing device 30 or hand gesture the rendering of a three-dimensional tracking container 60 on the first stereoscopic image 14. Figure 5A shows that an editing mode has been entered since cursor 32 has container 60 rendered at its tip. Figure 5A further shows that a container 60’ has already been placed on stereoscopic image 14 in this manner. White matter tracts and/or fibers 62 passing through three-dimensional tracking container 601 are highlighted.”).
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Figure 5B of Kou
Regarding Claim 6, Kou and Phillips teach the limitations of Claim 1 and Kou further teaches a step of tracking a medical instrument into the region of interest (corresponding disclosure in at least [0097], where there is a medical instrument (stylus) which is tracked into the ROI (the fiber) “fiber tracking using a stylus is depicted the local transformation of the physical stylus is always tracked by two cameras, the data can be retrieved by tracking the location of the stylus. The stylus has markers that can be identified by the cameras in infrared light”),
the instrument extending along a main axis and wherein the portion of the slice has a width depending on a distance between the instrument main axis and a target point and/or a height defined along the main axis of the instrument (corresponding disclosure in at least [0066], where the thickness (width) can be changed for the slice, and the shape itself can be changed “When the thickness of the rectangular box is reduced to a thin slice or a plane, only those fibers with their main orientation crossing the slice will be displayed. This rectangular box could also be a slab or a slice of an anatomical structure. By adjusting the orientation of the slice or plane, the user could select different fiber orientations” and further in [0064] “Suitable shapes include, but are not limited to, a sphere, disk, cylinder, ellipsoid, cube, cuboid, parallelepiped, a slice of the image, a slab of 3D anatomical organ, a manually drawn shape or surgical corridor, or any shape that is imported from other sources”).
Regarding Claim 7, Kou and Phillips teach the limitations of Claim 1 and Kou further teaches wherein the portion of the obtained slice is a strip delimited around the main axis of the instrument (corresponding disclosure in at least [0064] and Figure 5B, where only the portions through the instrument (container) are obtained “White matter tracts and/or fibers 62 passing through three-dimensional tracking container 601 are highlighted. In a refinement, white matter tracts and/or fibers not passing through three-dimensional tracking container 60 are removed or hidden from the first stereoscopic image 14”)
Regarding Claim 8, Kou and Phillips teach the limitations of Claim 1 and Kou further teaches a step of tracking a medical instrument into the region of interest, said instrument extending along a main axis and wherein the obtaining of the slice comprises the determination of a plane in which the instrument main axis extends (corresponding disclosure in at least [0061], where each time the orientation is changed, the image will update accordingly based off the reference, determining which plane is being observed “a user (via the pointing device) can translate or rotate first reference plane 36 along a first axis 50 or second reference plane 38 along a second axis 52 or third reference plane 44 along a third axis with the two-dimensional reference image associated with the translating reference plane updating during the translation. Figures 3A and 3B show a rendering after a user has translated second reference plane 38 along axis 52”).
Regarding Claim 9, Kou and Phillips teach the limitations of Claim 1 and Kou further teaches wherein the point of interest belongs to the main axis of the medical instrument (corresponding disclosure in at least [0064], where the point of interest (tip of container) is where the image is captured from, which is the main axis “. Figure 5A shows that an editing mode has been entered since cursor 32 has container 60 rendered at its tip”),
the region of interest corresponding to a region in which the medical instrument has to be inserted or has been inserted according to this axis (corresponding disclosure in at least Figure 5A and [0064], where the region of interest is the brain/white matter tracts and anything that passes through the container (insertion) is imaged “Figure 5A further shows that a container 60’ has already been placed on stereoscopic image 14 in this manner. White matter tracts and/or fibers 62 passing through three-dimensional tracking container 601 are highlighted”).
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Figure 5A of Kou
Regarding Claim 10, Kou and Phillips teach the limitations of Claim 1 and Kou further teaches wherein the computation of the composite 2D image comprises the projection on said composite 2D image, of either the main axis of the medical instrument the slice being centered around this main axis, or the projection of medical intervention targets (corresponding disclosure in at least [0064] and Figure 5A, where the medical intervention targets (the white matter tracts or fibers) are projected (highlighted) in the image “Figure 5A further shows that a container 60’ has already been placed on stereoscopic image 14 in this manner. White matter tracts and/or fibers 62 passing through three-dimensional tracking container 601 are highlighted”).
Regarding Claim 11, Kou and Phillips teach the limitations of Claim 1 and Kou further teaches a step of selecting a projection among a plurality of projections, each projection being acquired or computed from the 3D image (corresponding disclosure in at least [0075], where a projection (subcomponent) can be selected from the stereoscopic image which is 3D “ the user can highlight and/or select a subcomponent of the stereoscopic image that is segmented out to form a stereoscopic sub-image that is independently editable at a voxel level”),
said selection depending on a point of view, said point of view preferably depending on position and/or orientation of a tracked device such as a medical instrument relative to the region of interest or an anatomical feature, or - said selection depending on the point of interest or on the region of interest (corresponding disclosure in at least [073], where the image selection is around a region of interest (white matter tracts) “a step of receiving image data having a discrete spatial resolution for locations in a subject (e.g., white matter tracts). At least one stereoscopic image 90 is rendered on display 12 from the image data”).
Regarding Claim 13, Kou and Phillips teach the limitations of Claim 1 and Kou further teaches a step of switching between two points of view, said method implementing the steps b) and d) for taking into account this point of view (corresponding disclosure in at least [0059], [0074], and [0066], where the device can go between any point of view depending on where the user chooses to look, with the image updating “While the glasses move, the stereoscopic image will update dynamically to display a different perspective of the rendered view to realize a 3D view effect.”).
Regarding Claim 14, Kou and Phillips teach the limitations of Claim 1 and Kou further teaches a step of switching between two slices, said method implementing the steps c) and d) for taking into account the second slice (corresponding disclosure in at least [0066] and [0059], where there can be different slices/orientations that can be viewed by the user specifically in the region of interest as specified in the steps “the application of container 60 selectively highlights fibers 62 that pass this rectangular box. When the thickness of the rectangular box is reduced to a thin slice or a plane, only those fibers with their main orientation crossing the slice will be displayed. This rectangular box could also be a slab or a slice of an anatomical structure. By adjusting the orientation of the slice or plane, the user could select different fiber orientations”).
Regarding Claim 17, Kou and Phillips teach the limitations of Claim 1 and Kou further teaches a step of displaying the composite image (corresponding disclosure in at least Figure5A and 5B and [0078], where there is a display for showing the images “The surgical navigation system 100 includes display 102 for rendering a stereoscopic image”).
Claims 12, 15-16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kou (WO2020205714A1) and Phillips (Anonymous: "Classic Planning Pinnacle 3 Instructions for Use", 1 June 2018 (2018-06-01), pages 1-344, XP055902089, disclosed in Applicant IDS) as applied in Claim 1 and in further view of Lang (US20180125584A1).
Regarding Claim 12, Kou and Phillips teach the limitations of Claim 1 and the 2D overall image ([0066] of Kou), but does not teach the image being one of the following: a radiographic image obtained by emission of x-ray to the anatomical region, a Digitally-Reconstructed Radiography, a computed Maximum Intensity Projection, a computed Average Intensity Projection, possibly with enhanced contrast, a computed Minimum Intensity Projection, a computed Locally Minimum, respectively Maximum, Intensity Projection.
Lang, in a similar field of endeavor, teaches a similar concept (surgical planning and imaging) of imaging in one of the following: a radiographic image obtained by emission of x-ray to the anatomical region, a Digitally-Reconstructed Radiography, a computed Maximum Intensity Projection, a computed Average Intensity Projection, possibly with enhanced contrast, a computed Minimum Intensity Projection, a computed Locally Minimum, respectively Maximum, Intensity Projection (corresponding disclosure in at least [0233], where one of the imaging types includes x-ray “ the OHMD can display a 2D virtual image of the patient. The image can be a transmission type image, e.g. an x-ray”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated using x-ray imaging to the anatomical region as taught by Lang. One of the ordinary skill in the art would have been motivated to incorporate this because x-ray imaging is used for generating 2D images and is also used to generate a 3D image from the 2D images.
Regarding Claim 15 and 20, Kou and Phillips teach the limitations of Claim 13 and Claim 14 and a relation between a main axis of a tacked device and the direction of a selected projection (corresponding disclosure in at least [0064] and Figure 5B, where the projection or slice is based on the direction of the instrument main axis “A user initiates with pointing device 30 or hand gesture the rendering of a three-dimensional tracking container 60 on the first stereoscopic image 14. Figure 5A shows that an editing mode has been entered since cursor 32 has container 60 rendered at its tip. Figure 5A further shows that a container 60’ has already been placed on stereoscopic image 14 in this manner. White matter tracts and/or fibers 62 passing through three-dimensional tracking container 601 are highlighted.”).
Kou does not teach switching when a relation is below or equal to a defined threshold.
Lang, in a similar field of endeavor, teaches a similar concept of switching when a relation is below or equal to a defined threshold (corresponding disclosure in at least [0769] where an image/POV (the cross section) of the viewed data is changed or switched when it exceeds a particular threshold depending on the tool angle or usage “the physical femoral cut exceeds a threshold value, e.g. 3 degrees more angulation in flexion direction and/or 2 mm greater cut depth (i.e. more bone removal), then the surgeon can modify the registration of the live data of the patient (e.g. the perimeter and/or cross-section and/or surface area and/or shape of the physical distal cut distal femoral bone) with the virtual data of the patient”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated switching when a relation is below or equal to a defined threshold as taught by Lang. One of the ordinary skill in the art would have been motivated to incorporate this because the user is able to view an updated image depending on a particular requirement based on where the medical tool is located. This provides a more updated image based on the area of interest.
Regarding Claim 16 and 19, the combined references teach the limitations of Claim 15 and 20, and Kou further teaches where an angle formed between said main axis of the tracked device and said direction is comprised in a range defined between 350 and 45° (corresponding disclosure in at least [0060], where the tracked device (pointing device) will form any angle or rotation, which is typically 30 to 150 degrees, between the given range “First reference plane 36 is oriented at a first angle Ai with respect to second reference plane 38 that is typically from 30 to 150 degrees. Input from the pointing device 30 can be received that selects positions or rotates at any angle of the first reference plane or the second reference plane wherein the first two- dimensional image and the second two-dimensional image update when their position or orientation changes (e.g. rotation at any angle)”).
Kou does not teach where this is the defined threshold.
Lang, in a similar field of endeavor, teaches a similar concept of a threshold based on an angle (corresponding disclosure in at least [0769] where an image/POV (the cross section) of the viewed data is changed or switched when it exceeds a particular threshold depending on the tool angle or usage “the physical femoral cut exceeds a threshold value, e.g. 3 degrees more angulation in flexion direction and/or 2 mm greater cut depth (i.e. more bone removal), then the surgeon can modify the registration of the live data of the patient (e.g. the perimeter and/or cross-section and/or surface area and/or shape of the physical distal cut distal femoral bone) with the virtual data of the patient”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated switching when a relation is below or equal to a defined threshold as taught by Lang. One of the ordinary skill in the art would have been motivated to incorporate this because the user is able to view an updated image depending on a particular requirement based on where the medical tool is located. This provides a more updated image based on the area of interest.
Response to Arguments
Applicant’s arguments filed 02/19/2026 in regards to the Drawing objections have been considered and are withdrawn in light of the amendments.
Applicant’s arguments filed 02/19/2026 in regards to the Claim objections have been considered and the previous objections have been withdrawn in light of the amendments.
Applicant’s arguments filed 02/19/2026 in regards to the 35 U.S.C. 112b rejections have been considered and are withdrawn in light of the amendments.
Applicant's arguments filed 02/19/2026 in regards to the 35 U.S.C. 102(a)(1) rejections and 35 U.S.C. 103 rejections have been fully considered but they are not persuasive.
Applicant’s arguments regarding the projection comprising at least radiographic image obtained from a medical imaging device with respect to claim 1 has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant further argues that Kou does not disclose a portion of the composite 2D image is a projection of the corresponding 3D slice from the same point of view, which replaces a portion of the 2D projection image. However, [0073]-[0077] of Kou discloses a 2D rendering from a composite image, which is collected from a medical imaging technique (i.e. functional magnetic resonance imaging, T1 or T2 weighted magnetic resonance imaging, computerized tomography, diffusion tensor imaging, computed tomography angiogram, magnetic resonance angiography, perfusion-weighted imaging, susceptibility-weighted imaging, ultrasound, mammography, photoacoustic images, and positron-emission tomography [0076). The images are aligned, meaning they are from the same point of view, and the slice is taken from a 3D space (as disclosed in [0073]).
With respect to Applicant’s arguments to the remaining claims, see page 13, regarding claims 2, 4-11, 13-14, and 17, these claims are not allowable based on their dependence to the independent claim 1 for at least the reasonings provided above.
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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/K.E.K./Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797
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