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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lang, U.S. Patent Publication Number 2021/0192759 A1.
Regarding claim 1, Lang discloses a system for computer assisted navigation during a surgery, comprising a computer platform operative to: obtain a computed tomography (CT) image of a pelvic region of a patient captured prior to the surgery, wherein the CT image of the pelvic region includes a target surgical area (paragraph 0235, pre-existing data of the patient including one or more imaging test or other types of data including metabolic or functional information can be obtained; paragraph 0266, an optional pre-operative imaging study can be obtained; paragraph 0667, preoperative imaging can entail a cross-sectional imaging modality, e.g. computed tomography), and process the obtained CT image to remove a femur contained in the pelvic region, wherein the processed CT image of the pelvic region includes a target surgical area without the femur (paragraph 1844, paragraph 1844, CT data can be imported into a software program to segment the femoral and/or tibial bones), obtain a point cloud representing a set of points of the pelvic region with a navigated instrument during the surgery (paragraph 1169, by moving the mechanical probe along the bone, cartilage, tissue and/or organ surface, the position of the tip of the probe can, for example, be registered and, for example, a point cloud can be generated; paragraph 1051, shapes or portions can be determined using a pointer or pointing device which can be tracked using a navigation system and navigation markers; points and point clouds generated; paragraph 1504, Mechanical probes, e.g. a pointer probe with attached RF markers, IR markers for navigation, optical markers, LED's and/or IMU's can be used to determine one or more points on the acetabulum and, for example, to generate a point cloud), merge the CT image and the point cloud, and register the target surgical area based on the merged CT image and point cloud (paragraph 0266, the pre-operative or intra-operative imaging study and any 3D reconstruction or 3D rendering can be used for generating a virtual surgical plan; virtual surgical plan can be registered; paragraph 0268, registration of the virtual data with live data can be performed using a variety of techniques; processed data can, for example, consist of mesh data, parametric surface data, point cloud data; paragraph 1180, By matching, aligning, superimposing or merging surfaces derived from pre-operative and intra-operative data, axis information obtained on pre-operative data, e.g. standing x-rays can be readily superimposed or merged with intra-operative data. The resultant model can be used to develop, derive and/or modify a virtual surgical plane; paragraph 1948, transformation can be used to merge and superimpose fluoroscopy images onto the live view).
Regarding claim 2, Lang discloses wherein the computer platform is further operative to: obtain from the CT image at least one known point of the pelvis (paragraph 1504, one or more pelvic x-rays are displayed; femoral and/or acetabular sizing and alignment data can be imported; figure 18A and 18B); obtain the known point as part of the point cloud with the navigated instrument, obtain a coarse alignment of the CT image with the known point from the CT image and the known point from the point cloud
(paragraph 0097, display virtual representations of one or more of a predetermined start point; paragraph 0258, optical imaging and/or 3D scanning probe used with an arthroscopic procedure can optionally be tracked by tracking the position, location, orientation, alignment and/or direction of movement using optical markers, e.g. with one or more geometric patterns; optical imaging and/or 3D scanning probe and/or an arthroscope used with an arthroscopic procedure can optionally be tracked by tracking the position, location, orientation, alignment and/or direction of movement using navigation markers; recognize the known geometry of the one or more probes and their location within a coordinate system).
Regarding claim 3, Lang discloses wherein the computer platform is further operative to use the coarse alignment to obtain a starting point for the merge of the CT image and the point cloud (paragraph 0259, If there is not sufficient commonality, additional scanning can be performed using the optical imaging and/or 3D scanner technique, for example to increase the spatial resolution of the scanned data, the accuracy of the scanned data and/or to fill any holes in the model or surface. Any surface matching algorithm known in the art can be utilized to register overlapping surface areas and thereby transform all surface portions into the same coordinate space, which Examiner interprets as a coarse alignment, in that there is not sufficient commonality).
Regarding claim 4, Lang discloses wherein the known point is an anterior superior iliac spine (ASIS) (paragraph 1477, Registration can be performed using anatomic structures such as the anterior superior iliac spine).
Regarding claim 5, Lang discloses wherein the known point is a fossa
(paragraph 1829, AP radiograph of the hip and/or pelvis can be by the OHMD superimposed onto the patient, e.g. in a plane parallel to the OR table or parallel to the original acquisition plane and extending for example, through the center of the acetabular fossa).
Regarding claim 6, Lang discloses wherein the known point is a centroid derived from edge points of the acetabulum or center of rotation of the acetabulum (paragraph 1477, one or more markers, e.g. optical markers, navigation markers, patient specific markers or templates, can be applied to the edge of the acetabulum, the inside of the acetabulum or a pelvic wall; paragraph 1504 a pointer probe with attached RF markers, IR markers for navigation, optical markers, LED's and/or IMU's can be used to determine one or more points on the acetabulum and, for example, to generate a point cloud. The points can be used for identifying the geometric center of the acetabulum).
Regarding claim 7, Lang discloses wherein the point cloud includes a plurality of points on an inner surface of an acetabulum and a fossa (paragraph 1829, AP radiograph of the hip and/or pelvis can be by the OHMD superimposed onto the patient, e.g. in a plane parallel to the OR table or parallel to the original acquisition plane and extending for example, through the center of the acetabular fossa; paragraph 1504, determine one or more points on the acetabulum and, for example, to generate a point cloud).
Regarding claim 8, Lang discloses wherein the navigated instrument includes a ball tip and the computer platform is operative to calculate, for each point of the point clouds, a point on a surface of the ball tip that touches the inner surface of the acetabulum based on the orientation of the navigated instrument and geometry of the ball tip (paragraph 1489, acetabular placement instrument 470 can be placed by the surgeon in the exposed acetabular fossa as shown in an illustrative example in FIG. 33; acetabular placement instrument can have the same shape and/or dimensions and/or radius and/or radii on the acetabular fossa facing surface as the acetabular cup or trial cup selected for implantation. The acetabular placement instrument can have a shape and/or dimension and/or radius and/or radii on the acetabular fossa facing surface matching the shape and/or dimensions and/or radius of the patient's acetabular fossa).
Regarding claim 9, Lang discloses wherein the computer platform obtains the set of points while the user continuously paints the surface of the acetabulum (paragraph 1049, points and point clouds generated can, for example, be used to “paint” the femoral geometry and/or shape and to generate a 3D model of the distal femur or portions thereof, e.g. as described in other parts of the specification; Paragraph 1758, surgeon “paints” the landmark surface, the position of the instrument tip can be calculated from the optical markers, LED's or navigation markers or other markers using some of the methods described in the specification, for example in the section with heading “Tracking of Surgical Instruments”, thereby generating a point cloud and/or surface of the anatomic landmark or the patient's anatomy, e.g. an articular surface).
Regarding claim 10, Lang discloses wherein the computer platform generates a segmented CT volume and the merge is performed by comparing the segmented CT volume to the point cloud (paragraph 0266, An optional pre-operative imaging study 40 can be obtained. An optional intra-operative imaging study 41 can be obtained. The pre-operative 40 or intra-operative 41 imaging study can be segmented 42, extracting, for example, surfaces, volumes or key features; the pre-operative or intra-operative imaging study and any 3D reconstruction or 3D rendering can be registered in a common coordinate system; paragraph 1844, CT data can be imported into a software program to segment the femoral and/or tibial bones).
Regarding claim 11, Lang discloses wherein: the computer platform generates the segmented CT volume which excludes the femur prior to the merge (paragraph 0266, An optional pre-operative imaging study 40 can be obtained. An optional intra-operative imaging study 41 can be obtained. The pre-operative 40 or intra-operative 41 imaging study can be segmented 42, extracting, for example, surfaces, volumes or key feature; paragraph 0260; paragraph 1498, OHMD can then display a bulls-eye or target like structure whereby the surgeon will aim the femoral reamers, impactors, femoral trials and the physical femoral component to be located in the center of the bulls-eye or target. The OHMD can display the desired entry point).
Regarding claim 12, Lang discloses wherein merging the point cloud with the segmented CT volume includes aligning respective sections of the point cloud with corresponding segmented CT volume (paragraphs 0327-0328, Upon successful alignment or matching, the surgeon command can register, for example, the virtual patient data and the live patient data or images and the; OHMD in the same common coordinate system; paragraph 1504, volumetric data can be registered to corresponding landmarks and/or surfaces in the physical patient, e.g. an acetabular edge or rim, an acetabular articular surface, an iliac wing surface, a symphysis pubis etc.; display the imaging study, optionally multiple 2D or 3D imaging studies, superimposed onto the live, physical anatomy of the patient).
Regarding claim 13, Lang discloses wherein the computer platform segments the CT image using a first artificial neural network (ANN) (paragraph 0266, when images of the patient are superimposed onto live data seen through the optical head mounted display, in many embodiments image segmentation can be desirable; any know algorithm in the art can be used for this purpose, for example, artificial neural networks).
Regarding claim 14, Lang discloses wherein the first ANN includes a trained machine learning algorithm that is trained by providing a CT image dataset including annotated target surgical areas and non-target surgical areas (paragraph 0331-0332, automatic or semi-automatic registration of virtual patient data in relationship to live patient data using image processing and/or pattern recognition and matching techniques; in some embodiments, image processing techniques, pattern recognition techniques or deep learning/artificial neural-network based techniques can be used; optionally, image processing and/or pattern recognition algorithms can be used to identify certain features; paragraph 1453, nerve roots can be highlighted using segmentation techniques known in the art, e.g. automatic or semi-automatic or manual segmentation; The area or volume that includes the click can be registered as a safety zone which the pedicle screw and any instruments used for the placement should not enter; paragraph 1764, highlighting sensitive anatomic structures overlaid on the live physical anatomy).
Regarding claim 15, Lang discloses wherein aligning respective sections of the point cloud with corresponding segmented CT volume is performed using a second ANN, wherein the second ANN includes a trained machine learning algorithm that is trained by providing an overlayed point cloud dataset with a CT image dataset including annotated target surgical areas and non-target surgical areas (paragraph 0299, registration can be maintained for each 2D image or 2D image slice, e.g. from a 3D dataset [e.g. an ultrasound, CT, MRI, SPECT, SPECT-CT, PET, PET-CT], in relationship to the corresponding cross-section of the physical body of the patient; For example, after an initial or subsequent registration, an imaging study, e.g. a 3D dataset [e.g. an ultrasound, CT, MRI, SPECT, SPECT-CT, PET, PET-CT], the physical body of the patient or the physical surgical site, optionally one or more physical tools, physical instruments, and/or physical implants, optionally one or more virtual tools, virtual instruments, virtual implants and/or at least portions of a virtual surgical plan, and one or more OHMDs can be registered in the same coordinate system, e.g. a common coordinate system; paragraph 1453, area or volume that includes the click can be registered as a safety zone; paragraph 1764, 3D reconstruction of a CT or MRI scan or other virtual data, e.g. data display or highlighting sensitive anatomic structures, overlaid on the live, physical anatomy of the patient).
Regarding claim 16, Lang discloses wherein registering the target surgical area includes generating a registration matrix of the target surgical area (paragraph 1817, surface patches can be transformed into a common coordinate system by determining a transformation matrix for each surface patch that is based on the tracking information for that patch).
Regarding claims 17-20, they are rejected based upon similar rational as above. Lang further discloses a computer program product (paragraph 1380.
Response to Arguments
Applicant's arguments filed 03/04/2026 have been fully considered but they are not persuasive.
Applicant argues the prior art cited Lang fails to disclose a CT image and processing an image to remove femur. Applicant argues Examiner rejected claim 11 as reciting the feature as amended, where the amended claim language discloses “processing the obtained CT image to remove a femur contained in the pelvic region, wherein the processed CT image of the pelvic region includes a target surgical area without the femur”. Examiner disagrees and responds claim 11 depend upon claim 10, and claim 10 in which the Examiner recited paragraph 1844, CT data can be imported into a software program to segment the femoral and/or tibial bones. Examiner further responds the original claim language of claim 11 recited “the obtained CT image contains a pelvis as the targeted area and a femur as a non-targeted area; and the computer platform generates the segmented CT volume which excludes the femur prior to the merge”, whereas now the claim recite the processed CT image of the pelvic region includes a target surgical area without the femur. Examiner cited Lang as disclosing paragraph 0248, image sensor can receive the observation beam reflected by the surface of the target object; paragraph 0260; paragraph 1498, OHMD can then display a bulls-eye or target like structure whereby the surgeon will aim the femoral reamers, impactors, femoral trials and the physical femoral component to be located in the center of the bulls-eye or target. The OHMD can display the desired entry point. Examiner responds Lang discloses an obtained CT image containing a pelvis as a targeted area and a femur as a non-targeted area, paragraph 0248, target object; paragraph 1498, OHMD can then display a bulls-eye or target like structure whereby the surgeon will aim, therefore indicating a targeted area and a non-targeted area.
Applicant argues claim 8, the prior art Lang fails to disclose a ball point probe. Examiner responds Lang discloses paragraph 1489, the acetabular placement instrument; and further discloses paragraph 1483, One or more optical markers can also be attached to the shaft of the acetabular reamer. By measuring the position of the one or more optical markers, e.g. two optical markers in two different locations along the shaft of the reamer, the long axis of the physical acetabular reamer can be determined using image or video capture and can be compared to the predetermined virtual reaming axis. Examiner therefore responds Lange disclose a ball tip to calculate a point on a surface.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wu et al., U.S. Patent Number 12,403,019 B2
Wu discloses col. 2, lines 50-54, first bone removal plan may be defined in the virtual coordinate space and may include coordinate locations for a first portion of bone removal from a virtual inner canal that may be representative of the inner canal of the femur of the patient.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Motilewa Good-Johnson whose telephone number is (571)272-7658. The examiner can normally be reached Monday - Friday 6am-2:30pm.
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MOTILEWA . GOOD JOHNSON
Primary Examiner
Art Unit 2616
/MOTILEWA GOOD-JOHNSON/Primary Examiner, Art Unit 2619
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