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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-11 and 14, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holladay et al., U.S. Patent Publication Number 2020/0321099 A1,in view of Chopra et al., U.S. Patent Publication Number 2022/0008141 Al, further in view of Gullotti et al., U.S. Patent Publication Number 2019/0209080 A1 and Speck et al., U.S. Patent Publication Number 2015/0331078 A1.
Regarding claim 1, Holladay discloses a method for using an augmented reality (AR) headset to co-localize an image data set with a body of a person, comprising: registering one or more initial visible markers attached to the body of the person, wherein the initial visible marker is located in a fixed position relative to an image visible marker (paragraph 0015, registering a tracking system and one or more models with an augmented reality (AR) visual field; marker device includes a first fiducial marker to provide a pattern that is visible in an image generated by a set of cameras have a fixed position with respect to a visualization space, e.g., the AR visual field; paragraph 0028, marker is placed adjacent or attached to a patient’s body); registering a location of one or more additional visible markers physically attached to the body of the person and in a 3D coordinate system as viewed by the AR headset of one or more initial visible markers (paragraph 0016, the marker device also include one or more second fiducial markers, detectable by a three-dimensional spatial tracking system; paragraph 0080, the position of the object sensor 438 within the patient's body, as represented by tracking data 426, may be registered into the AR space); transferring the 3D coordinate system as viewed by the AR headset of the one or more initial visible markers to the one or more additional visible markers (paragraph 0017, using the known, fixed position, of each camera with respect to the AR device, the identified portions of the marker pattern are converted to corresponding three-dimensional location in a three-dimensional spatial coordinate system of the AR system; paragraph 0080, generate additional transform matrices 412 and/or 414 to enable co- registration of additional data and visualization in the coordinate system); (provides the image data 472 (e.g., including a known location of the object tracking sensor 438) that may be used to facilitate generating the transform matrix) aligning the image data set (paragraph 0020, aligning one or more objects which have a Spatial position and orientation known in another coordinate system, with the coordinate system of the AR display).
However it is noted that Holladay discloses providing the image data, and aligning one or more objects with a known spatial position and coordinate system, but fails to specifically one or more additional marker, in preparation for the one or more initial markers losing their alignment accuracy to align the image data set with the body of the person and further fails to disclose utilizing the one or more additional visible markers in aligning the image data set with the body of the person.
Gullotti discloses registering one or more initial visible markers attached to the body of the person (paragraph 0027, registering the location of one or more fiducial markers inside or outside a surgical site of the patient; figure 4A), wherein the initial visible marker is located in a fixed position relative to an image visible marker (paragraph 0704, register the fiducial’s 3D location and orientation with respect to the coordinates of the 3D-tracking acquisition unit; paragraph 0006, radiopaque markers configured to be visually observable using an X-ray source or imager; paragraph 0032, one fixed or mobile marker); identifying a location of one or more additional visible markers physically attached to the body of the person and in a 3D coordinate system (paragraph 0497, the placement of one or more additional surface marker fiducials) as viewed by the AR headset of one or more initial visible markers (paragraph 0041, 3D tracking camera or imaging system configured to track the at least one trackable marker; figure 31, paragraph 0604, body-mounted 3D-tracking camera); transferring the 3D coordinate system, of the one or more initial visible markers to the one or more additional visible markers, in preparation for the one or more initial visible markers losing their alignment accuracy to align the image data set with the body of the person (paragraph 0019, register a unique orientation of the coordinate axes of the depth-stop fiducial, and/or detect how the depth-stop fiducial rotates and translates in 3D space between one or more registrations; paragraph 0515, after the surgical drape is applied over the skin-mounted fiducial, the over-the-drape-mating fiducial can then be used to interpret the position of the underlying skin-mounted fiducial; paragraph 0697, mating the second-half fiducial to the original fiducial marker placed on or inside soft tissue to maintain access to the fiducial after the introduction of surgical drapes and other obstructing materials; figure 6A).
However, it is noted that Holladay in view of Gullotti fail to disclose the additional marker registered and utilizing the one or more additional visible markers in aligning the image data set with the body of the person.
Chopra discloses registering one or more initial visible markers attached to the body of the person (paragraph 0012, one or more fiducial markers placed on a patient body; paragraph 0090, fiducials may be registered with the control unit), wherein the initial visible marker is located in a fixed position relative to an image visible marker (paragraph 0164, may use image scan data combined with one or more fiducial marker positions; the two image types can be correlated, and combined with an image correlation with a visual image and the electromagnetic image set 2010);
identifying a location of one or more additional visible markers physically attached to the body of the person and in a 3D coordinate system as viewed by the AR headset of one or more initial visible markers (paragraph 0165, identify markers in the image; determines if a marker is found; if the markers are found then are registered with Mct); transferring the 3D coordinate system, as viewed by the AR headset, of the one or more initial visible markers to the one or more additional visible markers (paragraph 0165, if the markers are found then are registered with Mct); and utilizing the one or more additional visible markers in aligning the image data set with the body of the person (paragraph 0178, the system may also use another exterior image set using fiducial markers having the same location as the first set).
It is further noted that Chopra, Holladay, and Gullotti fail to specifically recite transferring the 3D coordinate system.
Speck discloses transferring the 3D coordinate system (paragraph 0033, at least one second marker is provided to be arranged on a movable object such that the position and the orientation of the marker in the coordinate system of the tracking system can be detected during imaging and can be transferred to the coordinate system of the imaging system. This enables tracking of the orientation and position of image recording in a continuous fashion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include in the co- registration of additional data as disclosed by Holladay, preparing for markers covered by drapes of loss of alignment as disclosed by Gullotti, to maintain access to the fiducial after the introduction of surgical drapes and other obstructing materials. It further would have been obvious to include the additional fiducial markers in aligning an image as disclosed by Chopra, to produce an enhanced reality vision with matched fiducials, having in a high level of confidence, in that one of ordinary skill in the art would recognize the more fiducials/landmarks/points used to align to more accurate the final alignment of the correlated visual picture. It further would have been obvious to one having ordinary skill in the art to transfer the coordinate system as disclosed by Speck to enable tracking in a continuous fashion.
Regarding claim 2, Holladay discloses further comprising identifying that the one or more initial visible markers have diminished accuracy for alignment of the image data set (paragraph 0020, can include objects that are not visible within a visual field of the AR device; the sensors may be hidden from sight, including positioned within a patient’s body).
Chopra - paragraph 0165, system attempts to identify markers in the image.
Regarding claim 3, Holladay discloses wherein the one or more initial visible markers with a diminished accuracy for alignment are at least one of: one or more initial visible markers which have moved, one or more initial visible markers which potentially will move, a portion of one or more initial visible markers is covered, or a portion of the one or more initial visible markers is not recognizable (paragraph 0055, provides each of locations as 3D spatial coordinates in the tracking system coordinate space and may remain fixed if the marker device does not move in the tracking space or may vary over time if the marker device moves in tracking space).
Chopra further discloses in paragraph 0092, the fiducial marker may move in three dimensions during the course of a medical procedure; it should be appreciated that as a patient breaths, or moves for any reason, the fiducial marker will also move by an amount corresponding to its placement on the patient body; paragraph 0165, determines if a marker is found; if the markers are not found, the image is rejected and a new image is captured.
Regarding claim 4, Holladay discloses wherein utilizing the one or more additional visible markers further comprises utilizing the additional visible markers by at least one of: emphasizing, de-emphasizing, terminating, or removing the use of the additional visible markers (Holladay - paragraph 0037, multimodal marker device can be placed near a patient, e.g., next to or on the patient, during the acquisition of the first and second images; can be placed in a visibly unobstructed surface or attached to the patient’s body; one side surface of the marker that includes a fiducial marker located within a white colored border to provide contrast between the white border and the thick blacker border of the fiducial marker).
Regarding claim 5, Holladay discloses further comprising at least one of: de-emphasizing, terminating, removing, or emphasizing the use of the initial visible markers in aligning the image data set (paragraph 0029, marker identification may be fully automated and/or be user-interactive in response to a user input identifying the markers).
Regarding claim 6, Holladay discloses further comprising aligning the image data set with the body of the person using one or more visible markers on the body of the person as viewed through the AR headset and the fixed position of the image visible marker with respect to the visible marker as referenced to a representation of the image visible marker in the image data set (paragraph 0033, align internal anatomical structures (that are not visible in the real world) with the patient's body in the spatial coordinate system of the AR display, which may be moving with respect to the patient's body. Advantageously, by implementing the method 100, the transform computed at 110 changes in response to changing information in the acquired images).
Regarding claim 7, Holladay discloses further comprises receiving a notification that the one or more initial visible markers have moved upon detecting that a relative distance between two visible markers on body of
the person or on skin has changed, wherein the two visible markers become displaced visible markers (paragraph 0118, provides a visualization of the 2D images registered in the 3D image based on the transform T2. If the landmarks are properly aligned, as shown on the display 510, no correction may be needed. However, if the locations of landmarks in the 2D image do not align with their respective locations in the 3D image, correction may be needed to T2).
Chopra paragraphs 0191-0194, patient marker fiducials are correctly aligned and verified, so P.sub.o’ overlays on P.sub.o in the enhanced reality image, but the reference and sensed co-ordinates of a known model point do not line up and the system detects; there may be non-rigid motions so they won't align. The non rigid motion may be described in three categories: [0192] (1) Due to the marker patch (Po) motion on skin; [0193] (2) Due to model (Mi) movement, and [0194] (3) Due to Tool perforating out of the model constraints.
Regarding claim 8, Holladay discloses further comprising de- emphasizing or terminating use of the displaced visible markers for aligning the image data set (paragraph 0117, a user initiates corrections using mouse-down/drag/mouse-up action or other actions through the user interface; such transformations thus allow a user to change the view of a single image or the alignment of multiple images; paragraph 0118, if landmarks are properly aligned, as shown on the display, no corrections may be needed).
Regarding claim 9, Holladay discloses further comprising de- emphasizing the one or more initial visible markers and emphasizing only the additional visible markers (paragraph 0118, implementing corrections for transform T2, the domain registration manager 494 applies the transform T2 to the image data 472 and the output generator 512 provides a visualization of the 2D images registered in the 3D image based on the transform T2. If the landmarks are properly aligned, as shown on the display 510, no correction may be needed. However, if the locations of landmarks in the 2D image do not align with their respective locations in the 3D image, correction may be needed to T2).
Regarding claim 10, Holladay discloses further comprising re-aligning the image data set with the body of the person using the one or more additional visible markers that have been emphasized for alignment (paragraph 0118, a user can thus adjust the alignment of the 2D image with respect to the 3D image through the user interface; adjustment may include translation in two dimensions, rotation and/or scaling in response to instructions; may update the visualization shown in the display to show the image registration in response to each adjustment; paragraph 0122, corners of the marker, or other portions of thereof, may be illuminated or otherwise differentiated in the output visualization to confirm that such portions of the marker are properly registered).
Chopra discloses paragraph 0188, realign markers from the scan image position to the actual position.
Regarding claim 11, Holladay discloses further comprising identifying one or more additional visible markers which have been added to the body of the person and anchored to an inner physical layer of the body of the person (paragraph 0020, aligning one or more objects (physical and/or virtual objects), which have a spatial position and orientation known in another coordinate system, with the coordinate system of the AR display. The objects can include objects (e.g., sensors and/or models representing internal anatomical structures) that are not visible within a visual field of the AR device. For example, one or more sensors have position and orientation detectable by a three-dimensional tracking system. The sensors may be hidden from sight, including positioned within a patient's body as well as be part of a marker device).
Regarding claim 14, Holladay discloses further comprising identifying displaced visible markers due to a change in relative distance of the displaced visible marker with respect to at least one of: another visible marker, a visible landmark on the body of the person, a visible anatomical feature of the body of the person, a visible facial feature, a visible bone protrusion, a visible tissue protrusion, or a visible body contour (paragraph 0122, annotations are shown in output visualization to provide the user with addition information, such as distance from an object, e.g., to which an object tracking sensor is attached).
Chopra paragraph 0186, displacement of a known fiducial marker between it real image coordinates and sensed coordinates.
Regarding claim 15, Holladay discloses wherein registering the one or more additional visible markers includes transferring at least a portion of alignment influence for the image data set to the one or more additional visible markers (paragraph 0118, a user can thus adjust the alignment of the 2D image with respect to the 3D image through the user interface; adjustment may include translation in two dimensions, rotation and/or scaling in response to instructions; may update the visualization shown in the display to show the image registration in response to each adjustment).
Claim(s) 16-29 and 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holladay in view of Chopra.
Regarding claim 16, Holladay discloses a method for using an augmented reality (AR) headset to co- localize an image data set with a body of a person as viewed through the AR headset, comprising: obtaining a generated image of at least a portion of the body of the person represented image data set (paragraph 0080, generate additional transform matrices 412 and/or 414 to enable co-registration of additional data and visualization in the coordinate system; figure 9); aligning the image data set to the x-ray generated image by using data fitting to align identified anatomical structures in the image data set and the x-ray generated image (paragraph 0020, aligning one or more objects which have a spatial position and orientation known in another coordinate system, with the coordinate system of the AR display); registering one or more additional optical codes physically attached to the body of the person and in a 3D coordinate system of one or more initial optical codes (paragraph 0015, registering a tracking system and one or more models with an augmented reality (AR) visual field; marker device includes a first fiducial marker to provide a pattern that is visible in an image generated by a set of cameras have a fixed position with respect to a visualization space, e.g., the AR visual field; paragraph 0028, marker is placed adjacent or attached to a patient’s body); receiving a notification that one or more initial optical codes have moved (figure 9).
However it is noted that Holladay fails to disclose utilizing the additional optical codes to maintain alignment of the image data set with the body of the person by applying the 3D coordinate system as viewed by the AR headset to the additional optical codes.
Chopra discloses x-ray (paragraph 0084, data from pre-operative computed tomography angiography scan may be combined with visual image scans of a patient using one or more fiducial markers on or in the patient); registering one or more initial visible markers attached to the body of the person after alignment of the x-ray generated image to the portion of the body (paragraph 0012, one or more fiducial markers placed on a patient body; paragraph 0090, fiducials may be registered with the control unit; paragraph 0160, process may do fine optimization starting with the gross optimization data and refine the position and orientation of the detected SDDs using a weighted sum of various errors such as; average angular position, positional correlation over the entire shapes, error fit of the reference SDD over intensity data in the image scan data and projected correlation error at certain landmarks in each image, therefore performing alignment of the x-ray generated image, i.e. the image scan data, body, i.e. certain landmarks; paragraph 0161, read scan images provided and enhances the scan image with known geometry of imaged organs; mark possible candidate anatomical model and cross sections), (paragraph 0184, sensors of known location and position relative to the markers; paragraph 0178, control unit can collect the exterior image of the patient having fiducial markers on the skin); and utilizing the additional code to maintain alignment of the image data set with the body of the person by applying the 3D coordinate system as viewed with by the AR headset to the additional optical codes (paragraph 0164, using the fiducial markers as reference points to help correlate the visual picture; paragraph 0178, the two maps are then combined and correlated to produce and enhanced reality vision of the internal anatomy of a patient matched to the exterior fiducials).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include in the co- registration of additional data as disclosed by Holladay, the additional data as x-ray data and utilizing additional codes as disclosed by Chopra, to produce an enhanced reality vision with matched fiducials, having in a high level of confidence, in that one of ordinary skill in the art would recognize the more fiducials/landmarks/points used to align to more accurate the final alignment of the correlated visual picture.
Regarding claim 17, Holladay discloses wherein receiving a notification that the one or more initial optical codes have moved is performed by either: detecting that a relative distance between two optical codes on an outer layer of the body of the person or skin has changed, wherein the two optical codes become displaced optical codes; or receiving a user interface control message from a user that a position of the optical codes has changed due to movement of the skin (Holladay figure 9).
Regarding claim 18, Holladay discloses wherein utilizing the additional optical codes further comprises emphasizing use of the additional optical codes (Holladay - paragraph 0122, corners of the marker, or other portions of thereof, may be illuminated or otherwise differentiated in the output visualization to confirm that such portions of the marker are properly registered).
Regarding claim 19, Holladay discloses further comprising aligning the image data set and x- ray generated image with patient anatomy viewable through the AR headset using an initial optical code formed in a radiopaque marker represented in the x-ray generated image as referenced to the initial optical code formed in the radiopaque marker visible on the body (paragraph 0024, the marker device includes one or more radio-opaque objects in the tracking pad having a known position and orientation with respect to one or more tracking sensors; the marker device enables determining a transform to spatially align the space of the tracking system with the intra-operative; paragraph 0026, another transform is determined to spatially align the coordinate systems of the intra-operative images with the pre-operative CT scan).
Chopra further discloses paragraph 0079, radiopaque markers or other elements that can be detected by a scanning operation and export detected signals to a control unit.
Regarding claim 20, Holladay discloses further comprising de- emphasizing or terminating use of the displaced optical codes for aligning the image data set. (paragraph 0117, a user initiates corrections using mouse-down/drag/mouse-up action or other actions through the user interface; such transformations thus allow a user to change the view of a single image or the alignment of multiple images; paragraph 0118, if landmarks are properly aligned, as shown on the display, no corrections may be needed).
Regarding claim 21, Holladay discloses further comprising de- emphasizing initial optical codes for use in alignment which are not additional optical codes. (paragraph 0117, a user initiates corrections using mouse-down/drag/mouse-up action or other actions through the user interface; such transformations thus allow a user to change the view of a single image or the alignment of multiple images; paragraph 0118, if landmarks are properly aligned, as shown on the display, no corrections may be needed).
Regarding claim 22, Holladay discloses further comprising re-aligning the image data set with the body of the person using the one or more additional optical codes, which have been emphasized, as viewed through the AR headset (paragraph 0118, a user can thus adjust the alignment of the 2D image with respect to the 3D image through the user interface; adjustment may include translation in two dimensions, rotation and/or scaling in response to instructions; may update the visualization shown in the display to show the image registration in response to each adjustment; paragraph 0122, the corners of the marker may be illuminated or otherwise differentiated in the output visualization to confirm that such portions of the marker are properly registered).
Regarding claim 23, Holladay discloses further comprising identifying one or more additional optical codes which have been added to the body of the person and anchored to an inner layer of the body of the person (paragraph 0020, can include objects that are not visible within a visual field of the AR device; the sensors may be hidden from sight, including positioned within a patient’s body).
Regarding claim 24, Holladay discloses further comprising identifying an additional optical code attached to at least one of: a bone of the body of the person, a bone pin placed in a bone of the body of the person, an organ, a blood vessel or an inner tissue of the body of the person (figure 9).
Regarding claims 25, it is rejected based upon similar rational as above claims 16. Holladay discloses a system (400, system) for using an augmented reality (AR) headset (AR display, 510) to co- localize an image data set, containing a radiopaque marker, with a body of a person as viewed through the AR headset (figure 9), comprising: at least one processor of the AR headset (paragraph 0051, processor); a memory device (101) of the AR headset including instructions that, when executed by the at least one processor, cause the system to: obtaining an generated image of at least a portion of the body of the person represented in the image data set (figure 9); aligning the image data set to the generated image by using data fitting to align identified anatomical structures in the image data set and the x-ray generated image (paragraph 0018, align the tracking sensor with a coordinate system; register a tracking coordinate system with a prior three- dimensional (3D) image scan; may be a CT scan, MRI; paragraph 0025); registering one or more additional optical codes physically attached to the body of the person and in applying a 3D coordinate system of as viewed by the AR headset for one or more initial optical codes to the additional optical codes (paragraph 0015, utilizes a marker device that includes fiducial markers detectable by more than one modality; includes a first fiducial marker that is visible in an image generated by a set of cameras having a fixed position with respect to a visualization space and another set of one or more markers detectable by a three-dimensional spatial tracking system; paragraph 0018, register a tracking coordinate system with a prior three- dimensional (3D) image scan).
Regarding claim 26, Holladay discloses wherein utilizing the additional optical codes further comprises emphasizing use of the additional optical codes to maintain alignment of the image data set with the body of the person and terminating use of displaced optical codes for purposes of aligning the image data set with the body of the person (paragraph 0117,a user initiates corrections using mouse-down/drag/mouse-up action or other actions through the user interface; such transformations thus allow a user to change the view of a single image or the alignment of multiple images; paragraph 0118, if landmarks are properly aligned, as shown on the display, no corrections may be needed).
Regarding claim 27, Holladay discloses further comprising re-aligning the image data set with the body of the person using the one or more additional optical codes that have been emphasized (paragraph 0118, a user can thus adjust the alignment of the 2D image with respect to the 3D image through the user interface; adjustment may include translation in two dimensions, rotation and/or scaling in response to instructions; may update the visualization shown in the display to show the image registration in response to each adjustment; paragraph 0122, the corners of the marker may be illuminated or otherwise differentiated in the output visualization to confirm that such portions of the marker are properly registered).
Regarding claim 28, Holladay discloses further comprising identifying an additional optical code added to the body of the person that is attached to at least one of: a bone of the body of the person, a bone pin in a bone of the body of the person, an organ, a blood vessel or an inner tissue of the body of the person (Holladay -paragraph 0053, one or more multi-modal marker devices can be attached to the patient’s body or placed near the patient body; the combination marker system can include one or more marker tracking sensors; one or more sensors can be affixed relative to an object that is movable within the patient’s body).
Regarding claim 29, Holladay discloses further comprising identifying one or more additional optical codes that have become displaced optical codes due to a change in relative distance from at least one of: a visible landmark of the body of the person, a visible anatomical feature of the body of the person, a visible facial feature, a visible bone protrusion, a visible tissue protrusion, or a visible body contour (figure 9).
Regarding claim 32, Holladay discloses further comprising transferring of alignment accuracy in the 3D coordinate system as viewed by the AR headset of the one or more initial visible markers to the one or more additional visible markers (paragraph 0080, generate additional transform matrices 412 and/or 414 to enable co-registration of additional data and visualization in the coordinate system; figure 9).
Regarding claim 33, Holladay discloses further comprising transferring of alignment accuracy to the additional visible markers after aligning the image data set with the body of the person using one or more visible markers on the body of the person (figure 9).
Allowable Subject Matter
Claims 34 and 35 are allowed.
Claims 12 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: The prior art cited fails to render obvious increasing an alignment weighting for an additional visible marker added to the body of the person after determining that the additional visible marker is attached to the inner physical layer of the body of the person; as recited in dependent claim 12 and independent claim 34 and further decreasing an alignment weighting of displaced visible markers which decreases an amount the displaced visible markers are referenced in aligning the image data set with the body of the person, as recited in dependent claim 13 and independent claim 35.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 06/10/2026 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues Guilloti fails to disclose one or more additional markers that disclose “the one or more additional markers, in preparation for the initial markers losing their alignment accuracy to align the image data set with the body of the person”. Examiner responds Gullotti discloses paragraph 0019, register a unique orientation of the coordinate axes of the depth-stop fiducial, and/or detect how the depth-stop fiducial rotates and translates in 3D space between one or more registrations; paragraph 0515, after the surgical drape is applied over the skin-mounted fiducial, the over-the-drape-mating fiducial can then be used to interpret the position of the underlying skin-mounted fiducial; figure 6A, and paragraph 0697, mating the second-half fiducial to the original fiducial marker placed on or inside soft tissue to maintain access to the fiducial after the introduction of surgical drapes and other obstructing materials. Examiner therefore interprets the mating of the second half fiducial, after the surgical drape is applied as “in preparation for the initial visible markers losing their alignment accuracy to align the image data set with the body of the person", as disclosed by Applicant’s specification paragraph 0016, “The transfer of alignment accuracy may be in preparation for the initial visible markers losing their alignment accuracy to align the image data set with a body of the person. For example, the alignment accuracy may be reduced or lost when the initial visible markers are moved, covered, obscured, etc. during a medical procedure.”
Applicant argues Guilloti fails to disclose one or more additional visible markers, and that Guilloti only discloses markers with “radiopaque patterns (e.g., grid lines, letters, numbers, symbols, icon, etc.) embedded in the patch”. Examiner responds Guilloti discloses paragraph 0497, the placement of one or more additional surface marker fiducials.
In response to applicant's argument that Speck “correcting movement in a medical imaging system” in not the same as “aligning an image data set to a body of a person”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Examiner responds
Speck discloses in paragraph 0033, at least one second marker is provided to be arranged on a movable object such that the position and the orientation of the marker in the coordinate system can be detected during imaging and can be transferred to the coordinate system of the imaging system.
Applicant argues that “utilizing one or more additional markers in aligning the image data set with the body of the person” is not claimed, but rather “transferring the 3D coordinate system, as viewed by the AR headset, of the one or more initial visible markers to the one or more additional visible markers, in preparation for the initial visible markers losing their alignment accuracy to align the image data set with the body of the person”. Examiner responds Applicant’s claim recites “utilizing the one or more additional visible markers in aligning the image data set with the body of the person”.
Applicant argues Chopra fails to disclose two types of fiducial markers or transferring the 3D coordinate system from initial visible markers to additional visible markers. Examiner responds the combination of Gullotti, Speck, Holladay, Chopra would render obvious two types of fiducial markers and transferring the 3D coordinate system from initial visible marker to additional visible markers.
Applicant argues claims 2 and 3 further recite “diminished accuracy for alignment of the image data set”. Examiner responds Guillotti discloses paragraph 0515, after the surgical drape is applied over the skin-mounted fiducial, the over-the-drape-mating fiducial can then be used to interpret the position of the underlying skin-mounted fiducial; figure 6A, and paragraph 0697, mating the second-half fiducial to the original fiducial marker placed on or inside soft tissue to maintain access to the fiducial after the introduction of surgical drapes and other obstructing materials.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Row et al., U.S. Patent Number 12,322,124 B2
Row discloses in abstract patient tracker is adapted for attachment to a patient, and includes a hybrid marker having a radiological marker contained within an optical marker. The tracking system tracks the hybrid marker. A computing device obtains a three-dimensional image of a patient's anatomy and the attached patient tracker; identifies a three-dimensional portion of the hybrid marker within a scan volume; determines a location of the hybrid marker within the scan volume based on the identified three-dimensional portion; tracks the location of the hybrid marker in three-dimensional space using the tracking system while the patient tracker remains fixed to the patient; and registers the three-dimensional image in three-dimensional space based on a known geometric relationship between the location of the hybrid marker within the scan volume and the location of the hybrid marker in three-dimensional space.
Hynna et al., U.S. Patent Publication Number 2019/0125451 A1
Hynna discloses paragraph 0008, patient reference (e.g., a tracked reference marker) is placed in a fixed position relative to the patient anatomy of interest; the patient reference and/or part of the patient’s body may be inadvertently bumped or moved, resulting in a loss of registration; detection of a loss of registration; paragraph 0009, obtaining a second se to image data; identifying a transform.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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MOTILEWA . GOOD JOHNSON
Primary Examiner
Art Unit 2616
/MOTILEWA GOOD-JOHNSON/Primary Examiner, Art Unit 2619
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