DETAILED ACTION
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites, wherein registering the location of the target surgical area includes generating a registration matrix of the acetabulum.
The phrase “the location of the target surgical area” has lack of antecedent basis. As a result the scope of the limitation is unclear.
Claim 19 recites, “ wherein the computer platform is further operative to: generate a model of the acetabulum based on the registered location.” The phrase “the registered location” has lack of antecedent basis. As a result the scope of the limitation is unclear.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-9, 11-12, 15, 17 and 20 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Lang et al. ( US patent publication: . 20210192759, “Lang”).
Regarding claim 1, Lang teaches, A system for computer assisted navigation during a surgery, comprising a computer platform (“[0186] Registration: [0187] The different objects to be displayed by the OHMD computer graphics system (for instance virtual anatomical models, virtual models of instruments, geometric and surgical references and guides) are initially all defined in their own independent model coordinate system” operative to:
obtain a fluoroscopy image of the pelvic region of the patient captured during the surgery, (“[1953] The display of fluoroscopic images registered with the corresponding live data and anatomic landmarks of the patient and superimposed onto the corresponding live data and/or anatomic landmarks of the patient by the OHMD can be advantageous for any type of surgery that utilizes intra-operative fluoroscopy, e.g. spinal surgery, spinal fusions, hip replacement surgery, hip arthroscopy, shoulder replacement surgery and others.”)
determine a first center of rotation (C1) of an acetabulum of the patient in the fluoroscopy image, ([1097]….“The marking can be performed using the display of the OHMD unit, e.g. using a virtual user interface. For example, the surgeon can optionally point at or circle with his or her finger sensitive structure on the live surgical site including by optionally touching the sensitive tissue [1958] Since the fluoroscopic image is a 2D image and the patient's anatomy is three-dimensional, fluoroscopic images can be displayed centered over an anatomic structure,”)
determine a second center of rotation (C2) of the acetabulum of the patient using a navigated instrument trackable by an optical tracking device, (“1110] In hip replacement, the surgeon can perform intra-operative measurements using, for example, optical markers to determine the location of the center of rotation of the hip joint, to define femoral and acetabular landmarks, e.g. the top of the greater trochanter, the sulcus point, e.g. the lowest point between the greater trochanter and the femoral neck, and the lesser trochanter, the acetabular rim and/or the center of the acetabulum, e.g. by pointing at them using a pointer with one or more attached optical markers; these and other intra-operative measurements can be registered in the common coordinate system and can be used for the virtual surgical plan which can also be registered in the common coordinate system. “) and
register the fluoroscopy image in an optical coordinate system of the optical tracking device based on the determined first center of rotation (C1) and second center of rotation (C2). (Paragraph (1945-1952) describes registration of fluoroscopic image (where C1 is available) and 3D anatomical image (where C2 is available as center of rotation). Paragraph 1958 expressly teaches the registration s based on center of rotation of both images. “[1958] Since the fluoroscopic image is a 2D image and the patient's anatomy is three-dimensional, fluoroscopic images can be displayed centered over an anatomic structure, e.g. as an anchor point, and/or aligned with or parallel with a plane defined by anatomic structures or the OR table.”)
Claim 20 is directed to A computer program product comprising a non-transitory computer readable medium (“[1064]…..“The computer or computer workstation can include one or more displays, keyboard, mouse, trackball, mousepad, joystick, human input devices, processor, graphics processors, memory chips, storage media, disks, and software, for example for 3D reconstruction, surface displays, volume displays or CAD design and display, as well as optional CAM output. The software can include one or more interfaces for CAD design, for displaying the patient's anatomy, for displaying virtual surgical instruments and for displaying virtual implants, implant components, medical devices and/or medical device components.”) and its elements are similar in scope and functions of the elements of the device claim 1 and therefore claim 20 is rejected with same rationales as specified in the rejection of claim 1.
Regarding claim 2, Lang teaches, wherein the surgery includes a total hip arthroplasty. (“[1341] In another example, a surgeon can plan to make a bone cut to a proximal femur of a patient, e.g. for partial or total hip arthroplasty, or to a distal femur or proximal tibia, e.g. for partial or total knee replacement, or to a proximal humerus, e.g. for partial or total shoulder arthroplasty. The OHMD can display the virtual bone cut superimposed onto the uncut bone of the live patient.”)
Regarding claim 3, Lang teaches, wherein the fluoroscopy image includes an anterior/posterior (AP) image of the pelvic region.( [1821]…..”For example, an AP radiograph of the hip and/or pelvis can be by the OHMD superimposed onto the patient”)
Regarding claim 4, Lang teaches, wherein the AP image is obtained at approximately 90 degrees relative to the patient such that the fluoroscopy image identifies a functional pelvic plane (FPP). (“[1980] In surgery involving the hip joint, e.g. hip replacement surgery or hip arthroscopy, a 2D cross-sectional image can be projected by the OHMD so that the projection extends through the left anterior superior iliac spine or the right anterior superior iliac spine, or the symphysis pubis, or the left and right anterior superior iliac spine and the symphysis pubis, co-planar with the anterior pelvic plane; or a 2D cross-sectional image can be projected parallel to the OR table or at another angle to the OR table, optionally predefined, with the projection plane intersecting or tangent with one or more of the symphysis pubis or the greater trochanter or the lesser trochanter or the anterior surface of the femoral neck or the anterior surface of the femoral head or the anterior surface of the femoral shaft or the posterior surface of the femoral neck or the posterior surface of the femoral head or the posterior surface of the femoral shaft or the center of the femoral head or the anterior or posterior acetabular margin or the center of the acetabulum or the center of rotation of the hip joint, for example determined by tracking multiple optical markers attached to the distal femur during rotatory movement using an image and/or video capture system and/or 3D scanner integrated into, attached to or separate from the OHMD. Any other anatomic structure can be chosen to place the 2D cross-sectional image in tangent or intersecting fashion.”)
Regarding claim 5, Lang teaches, wherein determining C1 includes receiving user input about a curvature of the acetabulum, and wherein the computer platform is operative to generate a boundary and a center point of the boundary as C1. (“[1097]…..The marking can be performed using the display of the OHMD unit, e.g. using a virtual user interface. For example, the surgeon can optionally point at or circle with his or her finger sensitive structure on the live surgical site including by optionally touching the sensitive tissue”)
Regarding claim 6, Lang teaches, wherein C1 is a two-dimensional coordinate. (“(“[1958] Since the fluoroscopic image is a 2D image”. So C1 has two dimensional coordinates.)
Regarding claim 7, wherein C2 is a three-dimensional coordinate. (“[1958] Since the fluoroscopic image is a 2D image and the patient's anatomy is three-dimensional, C2 is created from a 3d image of the anatomy.” So the C2 will have a three-dimensional coordinate)
Regarding claim 8, Lang teaches, wherein the navigated instrument is used to obtain point cloud data from the acetabulum. (“[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.”)
Regarding claim 9, Lang teaches, wherein the computer platform is further operative to identify C2 using the point cloud data.([1504]……. In some embodiments, a laser scan or 3D scan of the acetabulum can also be obtained, for example with the laser or 3D scanner also registered in the common coordinate system. 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. The points can be used for identifying the geometric center of the acetabulum. Optionally, the center of the acetabulum can be medialized or lateralized, e.g. by moving the partial acetabular placement tool medially or laterally or by moving the center of the acetabulum for reaming and/or impacting medially or laterally on the point cloud with subsequent medialized or lateralized guidance of the reamer and/or impactor in the one or more OHMDs' displays”)
Regarding claim 11, Lang teaches, wherein determining C2 is performed using a femur tracker. (“ [0291]….In some embodiments, optical or RF tracker's or other tracking devices known in the art can be applied to the OHMD and/or the patient including select body parts or target tissues of the patient, e.g. the patient's knee. Using standard surgical navigation techniques known in the art, the spatial location of the optical or RF trackers can be recorded, for example for a starting pose or position or location. Movement of the trackers, e.g. induced by movement of the surgeon's head or body or by movement of at least a part of the patient, can then be tracked using the navigation system.”)
Regarding claim 12, Lang teaches, herein determining C2 using the femur tracker includes:
attaching the femur tracker to the patient, and manipulating a leg of the patient. (“ [0291]….In some embodiments, optical or RF tracker's or other tracking devices known in the art can be applied to the OHMD and/or the patient including select body parts or target tissues of the patient, e.g. the patient's knee. Using standard surgical navigation techniques known in the art, the spatial location of the optical or RF trackers can be recorded, for example for a starting pose or position or location. Movement of the trackers, e.g. induced by movement of the surgeon's head or body or by movement of at least a part of the patient, can then be tracked using the navigation system.”)
Regarding claim 15, Lang teaches, wherein registering the fluoroscopy image includes mating C1 and C2 coincident using vector manipulation. (“[1958] Since the fluoroscopic image is a 2D image and the patient's anatomy is three-dimensional, fluoroscopic images can be displayed centered over an anatomic structure, e.g. as an anchor point, and/or aligned with or parallel with a plane defined by anatomic structures or the OR table.”)
Regarding claim 17, Lang teaches, wherein registering the location of the target surgical area includes generating a registration matrix of the acetabulum. (“ [1947] Similarly, markers M.sub.0-M.sub.3 in the model coordinate system can be mapped to the markers R.sub.0-R.sub.3 identified in the fluoroscopy image using a transformation matrix T.sub.2. T.sub.2 can contain rotation, translation, projection and scaling components. The overall registration matrix T.sub.3 between marker coordinates R.sub.0-R.sub.3 from the fluoroscopy image and coordinates O.sub.1-O.sub.3 derived from the video image results from the concatenation of the inverse of Ti with T.sub.2.”)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lang in view of Signoretti et al. ( US patent Publication: 2022/0361955, “Signoretti”),
Regarding claim 10, Lang doesn’t expressly teach, wherein C2 is identified as a center point in a best fit sphere defined by the point cloud data.
However, Signoretti teaches, wherein C2 is identified as a center point in a best fit sphere defined by the point cloud data. (“[0124] In certain embodiments, the imaging device 500 obtains a single point cloud file in which the pelvic marker and the lunate surface of the acetabulum are visible. A point cloud matching algorithm may be run on the imaging data to identify the location and orientation of the pelvic marker in scan coordinates, and the orientation is then adjusted to patient coordinates. In certain embodiments, in the UI, a brush selector tool 505 (see FIG. 20) may be used to select points on the lunate surface of the acetabulum, and a sphere is fit to those points using a least squares calculation. The center of the best fit sphere in patient coordinates, relative to the center of the pelvic marker, gives the native center of rotation of the hip (see FIG. 21).”
Lang and Signoretti are analogous as they are from the field of medical imaging.
Therefore it would have been obvious for an ordinary skilled person in eth art before the effective filing date of the claimed invention to have modified Lang to have included C2 is identified as a center point in a best fit sphere defined by the point cloud data as taught by Signoretti.
The motivation for the above is to us known method of center of rotation detection for three dimensional image.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lang in view of Kostrzewski et al. ( US patent Publication: 20210391058, “Kostrzewski”).
Regarding claim 16, Lang doesn’t expressly teach, receive an input from the navigated instrument indicating a location of a verification divot, wherein the verification divot enables confirmation of navigational integrity during movement of the navigated instrument relative to the acetabulum.
However, Kostrzewski teaches, receive an input from the navigated instrument indicating a location of a verification divot, wherein the verification divot enables confirmation of navigational integrity during movement of the navigated instrument relative to the acetabulum. (“[0143] It is noted that the passive end effector may require calibration through the surgical robot 4 and camera track system 6 to precisely define a plane to which the surgical saw is constrained with respect to the robot arm 22. This calibration may be performed by moving the surgical saw in space and measuring the corresponding position with the tracking camera to define the plane. Alternative, calibration can be performed through use of specific divots provided in the passive end effector which are touched with a navigation probe.”)
Lang and Kostrzewski are analogous as they are from the field of medical procedure.
Therefore it would have been obvious for an ordinary skilled person in the art before the effective filing date of the claimed invention to have modified Lang to have included receiving an input from the navigated instrument indicating a location of a verification divot, wherein the verification divot enables confirmation of navigational integrity during movement of the navigated instrument relative to the acetabulum as taught by Kostrzewski.
The motivation is to get proper calibration in verification of proper identification of anatomical structure.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over .Lang in view of Galloway et al. ( US patent Publication: 20030000535, “Galloway”),
Regarding claim 18, Lang doesn’t expressly teach, wherein the computer platform further displays the registration matrix on a user interface in a surgical area during the surgery.
However, Galloway teaches, displays the registration matrix on a user interface in a surgical area during the surgery. (“ the present invention receives matrix information from the localizer DLL concerning the current position of the probe(s) in physical space and passes this and any registration matrices to the appropriate display DLLs .”)
Lang and Galloway are analogous as they are from the field of medical imaging.
Therefore it would have been obvious for an ordinary skilled person in eth art before the effective filing date of the claimed invention to have modified Lang to have included displaying the registration matrix on a user interface in a surgical area during the surgery as taught by Galloway.
The motivation for the above to provide user the visual mapping between two images.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Lang in view of Netravali et al. ( US patent Publication: 20230210542, “Netravali”).
Regarding claim 19, Lang doesn’t expressly teach, wherein the computer platform is further operative to: generate a model of the acetabulum based on the registered location.
Netravali teaches, generate a model of the acetabulum based on the registered location.(“[0046] As another example of monitoring location of various devices and structures in a three-dimensional coordinate space, prior to resection the surgeon may mechanically and rigidly couple an acetabular fiducial array 222 to the acetabulum 104. The acetabular fiducial array 222 may be coupled at any suitable location, such as the superior iliac spine 224 or the inferior iliac spine 226, or both. Once the acetabular fiducial array 222 is coupled to the acetabulum 104.”)
Lang and Netravali are analogous as they are from the field of medical procedure.
Therefore it would have been obvious for an ordinary skilled person in the art before the effective filing date of the claimed invention to have modified Lang to have generate a model of the acetabulum based on the registered location as taught by Netravali.
The motivation is to provide a visualization of registered acetabulum to the surgeon in guiding on-going surgery.
Allowable Subject Matter
Claims 13-14 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.
Claim 13 is objected because the combination of prior arts fails to expressly to teach, obtaining three-dimensional (3D) cone data representing manipulation of the leg of the patient relative to a center of rotation, and identifying a center of the 3D cone data as C2.
Claim 14 is objected by virtue of dependency.
Conclusion
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/TAPAS MAZUMDER/ Primary Examiner, Art Unit 2615