DETAILED ACTION
Claims 1-16 are pending in this application and have been examined under the priority date of 03/23/2021 in accordance with the applicant’s claim for foreign priority.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/15/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 16 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim of claims 14 and 15. See MPEP § 608.01(n). Accordingly, the claim 16 has not been further treated on the merits. Further, for the purposes of advancing compact prosecution, Examiner has interpreted claim 16 as being dependent on claim 15, however applicant is strongly encouraged to amend this for clarity.
Claims 1, 9, and 11 are objected to because of the following informalities:
Claims 1, 9, and 11 recites “relatively to” in reference to determining the location of a point in a reference system, Examiner believes this should recite “relative to” rather than “relatively to”, applicant is respectfully encouraged to amend to clarify or correct this limitation.
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.
1. Claims 1-6 and 8-16 are rejected under 35 U.S.C. 103 as being unpatentable over Park (US 20160228196 A1) in view of Navab (WO 2017117517 A1).
Regarding claim 1 Park discloses; A method for locating at least one characteristic point in a region of a joint having a joint center (AC, HC, KC) (Park, [0018] the system may identify knee and ankle joint centers, [0039] Figure 14 shows the femur head with the joint center indicated (52), the femur head is the end of the bone),
the joint center (AC, HC, KC) being an end of a bone (T, F) (Park, [0018] the system may identify knee and ankle joint centers, [0039] Figure 14 shows the femur head with the joint center indicated (52), the femur head is the end of the bone),
a bone tracker (TF, TT) has been fixed to said bone and defines a reference system (RefT, RefF) (Park, [0142] Points on the bones are tracked, [0019]- [0021] points on the locations of interest on the bones are assigned to generate a coordinate system),
the method comprising the following steps being implemented in a processing unit of a medical imaging system (Park, Figure 1A shows the processor (CPU) being connected to an MRI system, [0078] the system has a CPU linked to an MRI system for carrying out the process):
- acquiring at least one image of a region of interest of a joint comprising or near the joint center (Park, [0016] acquiring MRI Coil images of the patient’s knee which includes the joint region),
[ a calibration phantom PH with a tracker T_PH being visible in the image,
said calibration phantom PH being in the field of view of the imaging device during the acquisition of the image, the relative position between radio-detectable elements of PH and the tracker T_PH being known,]
the tracker TPH being located in a reference system RefPH (Park, [0142] Points on the bones are tracked, [0019]- [0021] points on the locations of interest on the bones are assigned to generate a coordinate system, all points are located in the reference system),
[ the position of the bone tracker (TF, TF) with respect to T_PH being known at the time of acquisition; ]
[- determining a transform matrix between the reference system of the calibration phantom and the reference system of the region of interest from the position of the calibration phantom PH in the image, the calibration phantom being located in said region of interest and in the reference system of the region of interest; ]
[- determining from, a transform matrix between the reference system of the bone tracker and the reference system of the calibration phantom and from the transform matrix between the reference system of the calibration phantom and the reference system of the region of interest, the transform matrix between the reference system of the region of interest and the reference system of the bone tracker;]
- determining a position of each of the at least one characteristic point in the reference system of the region of interest of the joint (Park, [0095]- [0096] and Figure 1 E there are points assigned to the images (points 60 and 62 on figure 1E which are the tracker points) and these are known positions on the images within the coordinate system on the joint region of interest (16 on Figure 1D));
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(Park, Figure 1D)
- determining the location of each of the said at least one characteristic point in the region of interest relatively to reference system of the bone tracker from the transform matrix between the reference system of the region of interest and the reference system of the bone tracker and from the position of said characteristic point in the reference system of the region of interest of the joint (Park, [0085] all the points of interest for different parts of the joint are stored in a matrix where the coordinates are in global format which indicates these positions are relative to the reference system).
Park does not disclose;
a calibration phantom PH with a tracker T_PH being visible in the image,
said calibration phantom PH being in the field of view of the imaging device during the acquisition of the image, the relative position between radio-detectable elements of PH and the tracker T_PH being known,
the position of the bone tracker (TF, TF) with respect to T_PH being known at the time of acquisition;
- determining a transform matrix between the reference system of the calibration phantom and the reference system of the region of interest from the position of the calibration phantom PH in the image, the calibration phantom being located in said region of interest and in the reference system of the region of interest;
- determining from, a transform matrix between the reference system of the bone tracker and the reference system of the calibration phantom and from the transform matrix between the reference system of the calibration phantom and the reference system of the region of interest, the transform matrix between the reference system of the region of interest and the reference system of the bone tracker;
However, in the same field of endeavor Navab teaches;
a calibration phantom PH with a tracker T_PH being visible in the image (Navab, [0042] system has a reliable calibration phantom with characteristics, [0115] the system uses a calibration phantom which has radio detectable markers that are visible on the image [0187] the calibration phantom has points that are visualized and used to map to the reference coordinate spaces, Figure 7 shows the visualization of the acquired point data (CBCT data and points Pc and PCBCT) from the phantom (phantom tracker)),
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(Navab, Figure 7)
said calibration phantom PH being in the field of view of the imaging device during the acquisition of the image (Navab, [0115] the phantom is imaged using an X-ray imaging), the relative position between radio-detectable elements of PH and the tracker T_PH being known (Navab, [0115] the phantom has radio detectable markers that are visible on the image, [0227]-[0228] the positions of markers on the patient, the tools and the CBCT data (phantom calibration data) are known relative to one another),
the position of the bone tracker (TF, TF) with respect to T_PH being known at the time of acquisition (Navab, [0022]- [0026] figures 10-13 show the tracking of the trackers on the CBCT Volume (phantom), the x-ray source, the tools and patient relative to one another. These positions are known at the time of the imaging);
- determining a transform matrix between the reference system of the calibration phantom and the reference system of the region of interest from the position of the calibration phantom PH in the image (Navab, [0237] a reconstruction transformation is made for the pose/position estimation between the CBCT volume (calibration phantom) and the patient (patient body contains the ROI), [0238] the transformation is generated as a matrix), the calibration phantom being located in said region of interest and in the reference system of the region of interest (Navab, [0178] the transformation matrix is computed between the patient and the phantom (Reference and phantom) and this is done for the region in which surgery is being performed (region of interest));
- determining from, a transform matrix between the reference system of the bone tracker and the reference system of the calibration phantom and from the transform matrix between the reference system of the calibration phantom and the reference system of the region of interest (Navab, [0263]-[0268] Figure 10, shows multiple transformation matrices being computed, where CBCT is the phantom, M is the marker on the patient (bone marker) and C-arm is the surgical instrument and camera location, the transformation matrices are used to determined positions of each component relative to the surgical system), the transform matrix between the reference system of the region of interest and the reference system of the bone tracker (Navab, [0263] the tracker on the region of interest is denoted in figure 10 as tracker M, to get the transformation matrix between tracker M (region of interest tracker) and the reference coordinate system (tracker assigned to the surgical instrument) transforms using all trackers (phantom, reference, region of interest) are used);
The combination of Park and Navab would have been obvious to one of ordinary skill in the art prior to the effectively filed date of the presently claimed invention. Park teaches a method of planning an arthroplasty using medical images and point tracking on the patient, however it does not teach the use of a phantom to calibrate the system using multiple transformation matrices. However, in the same field of endeavor Navab teaches this deficiency by using a phantom to calibrate a robotic surgical instrument, and using multiple transformation matrices to accomplish the determination of tracker reference systems and positions of system components. The addition of Navab’s teaching of the use of a calibration phantom allows the surgical team to calibrate the surgical instruments and surgical imaging system accurately and without any additional radiation exposure to the patient. (Navab, [0263]- [0268])
Regarding claim 2 the combination of Park and Navab teaches; The method according to claim 1, wherein at least two 2D projection images are acquired (Navab, [0178] the patient’s 2D images (which are the region of interest for surgery and the markers for the points of interest/characteristic points) are captured then registered to a 3D volume),
wherein the step of determining ((Navab, [0178] the registration of the 2D patient images, (which contain the characteristic points) is register by computing a projection matrix, [0066] part of the registration and projection computation involves the step of reconstruction projection to register the images, which is analogous to back projection, [0077] described the reconstruction process as being the Feld Kamp method which uses multiple back projections, therefore there are at least 2. [0078]- [0079] these are used for point matching of features on the patient (characteristic points)),
the position of the characteristic point in the reference system of the region of interest, being the intersection between these backprojection lines (Navab, [0077]-[0079] multiple filtered back projections are computed (Feld Kamp Method) to generate a 3D model of the patient, which includes estimation of 3D point location on the patient, this is done using a laser and imaging this and then reconstructing as detailed in [0077], where positions of points of interest are located where projections of the laser (which is then back projected) intersect with a grid).
The combination of Park and Navab would have been obvious to one of ordinary skill in the art prior to the effectively filed date of the presently claimed invention. Park teaches a method of robotic arthroplasty, but does not teach the use of back projection as part of its method of computation for the procedure. However, Navab, teaches this deficiency, teaching that multiple back projections are used to generate a reconstruction of the patient’s body part that is being operated on from 2D X-rays, and to estimate the location of points of interest in doing this. The motivation for the combination lies in that Navab’s method allows for accurate calibration of the surgical system, and allows the system to calibrate and compute a model without previous models. (Navab, [0070])
Regarding claim 3 the combination of Park and Navab teaches; The method according to claim 2, wherein the characteristic point is the ankle center (Park, [0018] ankle centers (characteristic point) are identified in 2D images),
and wherein the 2D projection images are orthogonal acquisitions (Navab, [0036] alignment of 2D x-rays (2D projection images) is used to generate a 3D model a body part of interest contains points of interest, since the images are X-rays, the acquisition is orthogonal),
preferably frontal and sagittal to locate the characteristic points on the talus and the distal tibia (Park, [0020] the images show the ankles from all imaging directions, which includes the tibia and the talus).
The combination of Park and Navab would have been obvious to one of ordinary skill in the art prior to the effectively filed date of the presently claimed invention. Park teaches a method of robotic arthroplasty using MRI images. Navab teaches a method of calibrating a robotic surgical system using x-ray images and CT images. The motivation for the combination lies in that the use of CT and X-ray images rather than MRI allows for faster calibration of the system because the images can be acquired faster. (Navab, [0031]- [0036])
Regarding claim 4 the combination of Park and Navab teaches; The method according to claim 2, wherein the characteristic point is the ankle center (Park, [0018] ankle centers (characteristic point) are identified in 2D images), wherein the 2D projection images correspond to acquisition with several orientations (Navab, [0036] alignment of 2D x-rays (2D projection images) is used to generate a 3D model a body part of interest contain points of interest, since the images are X-rays the acquisition is orthogonal, [0299] the orientations of the images are visualized together, indicating the images are captured at multiple orientation), preferably +15° and - 15° from the frontal orientation to detect malleoli of the tibia and fibula.
The combination of Park and Navab would have been obvious to one of ordinary skill in the art prior to the effectively filed date of the presently claimed invention. Park teaches a method of robotic arthroplasty using MRI images. Navab teaches a method of calibrating a robotic surgical system using x-ray images and CT images. The motivation for the combination lies in that the use of CT and X-ray images rather than MRI allows for faster calibration of the system because the images can be acquired faster. (Navab, [0031]- [0036])
Regarding claim 5 the combination of Park and Navab teaches; The method according to claim 2, wherein the characteristic point is the hip center (Park, [0019] the hip center is identified from 2D MRI scans), the 2D projection images (Navab, [0036] alignment of 2D x-rays (2D projection images) is used to generate a 3D model a body part of interest contain points of interest, since the images are X-rays the acquisition is orthogonal, [0299] the orientations of the images are visualized together, indicating the images are captured at multiple orientation), preferably to +30° and -30° from the frontal orientation to detect the center of the hip ball.
The combination of Park and Navab would have been obvious to one of ordinary skill in the art prior to the effectively filed date of the presently claimed invention. Park teaches a method of robotic arthroplasty using MRI images. Navab teaches a method of calibrating a robotic surgical system using x-ray images and CT images. The motivation for the combination lies in that the use of CT and X-ray images rather than MRI allows for faster calibration of the system because the images can be acquired faster. (Navab, [0031]- [0036])
Regarding claim 6 the combination of Park and Navab teaches; Method according to claim 5 (Park, figures 21-36 3D bone models generated from MRI scans).
Regarding claim 8 the combination of Park and Navab teaches; The method according to claim 1 (Park, [0018] the system denotes where the ankle, hip and knee centers are).
Regarding claim 9 the combination of Park and Navab teaches; Method for determining alignment parameters of a tibia bone,
a first end of the tibia bone being an ankle joint (Park, [0020] points of interest on the tibia bone are identified where one is the ankle joint and one end is the knee joint),
a second end of tibia bone being a knee joint (Park, [0020] points of interest on the tibia bone are identified where one is the ankle joint and one end is the knee joint),
a tracker TT has been fixed to the tibia bone and defines a reference system RefT (Park, [0020] reference points are notes for each of the spots identified, and used as references),
the method comprising:
- locating at least one characteristic point in a first region of interest claim 1(Park, [0020] points of interest on the tibia bone are identified where one is the ankle joint and one end is the knee joint);
- locating at least one characteristic point in a second region of interest (Park, [0020] points of interest on the tibia bone are identified where one is the ankle joint and one end is the knee joint);
- calculating at least one alignment parameter (Park, [0062]- [0064] points of interest determined in [0020] (ROIs 1 and 2) and used in determining the mechanical alignment of the joint, this is used to help compute the surgical parameters to align the joint before and after surgery).
Regarding claim 10 the combination of Park and Navab teaches; The method as claimed in the preceding claim,
wherein a tracker T_Tbis has been fixed to the tibia (Park, [0064] a marker/axis is set on the tibia center for mechanical estimation and modeling),
so that trackers TT and TTbis are on both sides of an osteotomy (Park, [0073]- [0077] Figures 1H-1I show the positioning of the markers near the drill slots (osteomy), Figure 1J shows markers (42) on each side of the cutting region (38) ),
tracker TTbis defining a reference system RefTbis (Park, [0064] a marker/axis is set on the tibia center for mechanical estimation and modeling, defining the axis is analogous to defining a reference system),
said method comprising locating at least one characteristic point in the first region of interest claim 1 and/or comprising locating at least one characteristic point in the second of interest relative to Ref Tbis by means of the method according to claim 1(Park, [0020] points of interest on the tibia bone are identified where one is the ankle joint and one end is the knee joint, all the appoints are relative to each other on the bone).
Regarding claim 11 the combination of Park and Navab teaches; Method for determining alignment parameters of a femur bone,
a first end of the femur bone being a hip joint (Park, [0019] the femur is mapped out including the hip center, and the knee center),
a second end of femur bone being a knee joint (Park, [0019] the femur is mapped out including the hip center, and the knee center),
a tracker T_F has been fixed to the femur bone and defines a reference system RefF (Park, [0019] the mapping of the femur is used to define coordinate planes for future mappings, which is analogous to setting a reference system),
the method comprising:
- locating at least one characteristic point in a first region of interest (ROI) comprising the knee joint relatively to the reference system RefF by means of the method according to claim 1(Park, [0019] the femur is mapped out including the hip center, and the knee center, these points are located in the reference system for the femur);
- locating at least one characteristic point such as the hip center in the third region (RO13) of interest comprising the hip center relatively to the reference system RefF by means of the method according to claim 1 (Park, [0019] the femur is mapped out including the hip center, and the knee center, these points are located in the reference system for the femur);
- calculating at least one alignment parameter from the location of said characteristic points located relatively to RefF in the first and/or second region of interest(s) (Park, [0064] the defined reference system for the mapped bone is aligned with the mechanical axes to help map out the procedure).
Regarding claim 12 the combination of Park and Navab teaches; The method as claimed in the preceding claim, wherein a tracker T_Fbis has been fixed to the femur, so that trackers TF and TFbis are on both sides of an osteotomy (Park, [0151]-[0157] the Femur cutting jig is made from mapping the points of interest and contains to two points on either side of the incision site),
tracker TFbis defining a reference system RefFbis (Park, [0019] the femur is mapped out including the hip center, and the knee center, these points are located in the reference system for the femur),
said method comprising locating at least one characteristic point in the first region of interest claim 1 and/or comprising locating at least one characteristic point in the third region of interestclaim 1(Park, [0019] the femur is mapped out including the hip center, and the knee center, these points are located in the reference system for the femur, the femur ends would be multiple regions of interest, and the system locations numerous landmark points including the joint ends in those regions).
Regarding claim 13 the combination of Park and Navab teaches; The method as claimed in claim 11
wherein the location of any characteristic point in the first region of interest (Park, [0172]-[0173] the joints are rotated approximately 3 degree to identify the alignment and rotation orientation of the joint for the procedure, the condylar/joint end regions being analyzed in this step are the regions of interest that have been mapped with points of interest).
Regarding claim 14 the combination of Park and Navab teaches; A method for planning an optimal surgery around a knee joint of a patient (Park, [0007] - [0012] the method described is for planning an arthroplasty),
comprising a step of determining alignment parameters (Park, [0064]-[0065] the femur and tibia mechanical axes are aligned to one another) according to one of claim 9
a surgery being planned based on these parameters in order to be executed manually or by a robot (Park, [0064]-[0066] the knee arthroplasty is planned based on these mapping and alignment parameters).
Regarding claim 15 the combination of Park and Navab teaches; Medical system comprising a processor configured for implementing a method according to claim 1 (Park, [0078] system has a CPU to execute the program).
Regarding claim 16 the combination of Park and Navab teaches; Medical system according to claim 15, comprising a device for implementing the planned surgical procedure according to claim 14 (Park, [0077]-[0079] and Figure 1A the system is set up to automatically map out and execute parts of the surgery using a robotic device).
2. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Park (US 20160228196 A1) in view of Navab (WO 2017117517 A1) and in further view of Crawford (US 11317971 B2).
Regarding claim 7 the combination of Park and Navab teaches; The method according to claim 1 (Navab, [0115] the phantom has radiopaque markers that present in the image, [0178] the phantom points are registered to the x-ray images, and therefore the tracker points on the phantom are in the same space as the reference points),
[said transform matrix between the reference system of the bone tracker and the reference system of the calibration phantom being a unitary matrix,]
the reference system of calibration phantom being equal to the reference system of the tracker bone (Navab, [0115] the phantom has radiopaque markers that present in the image, [0178] the phantom points are registered to the x-ray images, and therefore the tracker points on the phantom are in the same space as the reference points).
The combination of Park and Navab would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. Park teaches a method of planning an arthroplasty using medical images and point tracking on the patient, however it does not teach the use of a phantom to calibrate the system using multiple transformation matrices. However, in the same field of endeavor Navab teaches this deficiency by using a phantom to calibrate a robotic surgical instrument, and using multiple transformation matrices to accomplish the determination of tracker reference systems and positions of system components. The addition of Navab’s teaching of the use of a calibration phantom allows the surgical team to calibrate the surgical instruments and surgical imaging system accurately and without any additional radiation exposure to the patient. (Navab, [0263]-[0268])
Neither Park nor Navab teaches; said transform matrix between the reference system of the bone tracker and the reference system of the calibration phantom being a unitary matrix,
However, in the same field of endeavor Crawford teaches; said transform matrix between the reference system of the bone tracker and the reference system of the calibration phantom being a unitary matrix (Crawford, column 22 lines 10-37, The marks on the bone (bone tracker reference system) and the markers on the tools and other parts of the system (calibration) are orthogonal to one another, Column 32, lines 4-30 matrices are generated using the positions of these trackers, the vectors indicating the positions are orthogonal, therefore when the matrices are generated they will be unitary matrices mathematically),
The combination of Park, Navab and Crawford would have been obvious to one of ordinary skill in the art prior to the effective filing date of the presently claimed invention. Park and Navab both teach methods of robotic surgery using matrix calibration, however neither teaches unitary matrices being used. Crawford teaches this deficiency, then motivation for the addition of Crawford is that the use of unitary matrices or orthogonal vectors which form unitary matrices is advantageous in precise calibration of the system (applicant’s specification Page 17 lines 10-20).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. For a listing of analogous art as cited by the examiner please see the attached PTO-892 Notice of References Cited form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JORDAN M ELLIOTT whose telephone number is (703)756-5463. The examiner can normally be reached M-F 8AM-5PM ET.
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/J.M.E./Examiner, Art Unit 2666
/EMILY C TERRELL/Supervisory Patent Examiner, Art Unit 2666