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) 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karlsson et al (US Pub 2018/0177600 A1 in IDS).
Regarding Claim 1, Karlsson et al teaches a system (100 in Fig.1) comprising:
a 3D model (step 220, step 230 in Fig. 2, 3D virtual model, Paragraph [0071] “In step 220: obtaining a three-dimensional virtual model of the joint which is based on the received medical image data.”) of an orthopedic element ([0031] “The three-dimensional virtual model of the joint may be obtained in many different ways. It may e.g. be obtained from a storage media, or be generated based on a series of radiology images captured during a process of scanning radiology images through different layers of the anatomical joint or part of it, which captures all the radiology image data necessary to generate a three-dimensional virtual model of the anatomical joint or part of it in an image segmentation process based on said radiology images. “)
comprising an operative area generated from at least two 2D radiographic images (1100 in Fig. 11; Paragraph 0113, “… Medical image data may also be obtained in step 1120 from a different kind of image source that provides 2D image data… “),
wherein at least a first radiographic image is captured at a first position, and wherein at least a second radiographic image is captured at a second position, and wherein the first position is different than the second position (Figs. 1, 11; Paragraph 0035, “[0117] The operator then positions 1170 a virtual implant template in the three-dimensional virtual model of the joint. The virtual implant template may preferably have an implant hat H corresponding to the implant area. In the case of a circular implant, the implant hat H preferably has the shape of a cylinder. In the case of a twin implant, the implant hat H instead preferably has the shape of two partly overlapping cylinders. The positioning may be automated or manual, or partly automated and partly manual, e.g. by the processor 120 proposing a position which can then be adjusted manually by the operator. The system may e.g. automatically propose a position which the operator can then adjust manually. The virtual implant template is first placed so that the cross-section area of the implant hat H in a direction perpendicular to the implant axis A covers at least a major part of the damage. Then, the implant axis A is tilted, while the position of the cross-section area of the implant hat H in the joint is maintained.”);
a computational machine (processor 120 in Fig. 1) configured to identify an area of bone aberration on the 3D model (step 220, step 230 in Fig. 2, “[0071] In step 220: obtaining a three-dimensional virtual model of the joint which is based on the received medical image data.
[0072] In step 230: identifying damage in the joint based on the received medical image data and/or the three-dimensional virtual model of the joint.”) and
further configured to apply a surface adjustment algorithm, wherein the surface adjustment algorithm is configured to remove the area of bone aberration from the 3D model and estimate a topography a bone surface to replace the area of bone aberration (See FIGS. 9a and 10a; Paragraph [0105] “The customized top surface of the implant hat H may be generated to correspond to a simulated healthy cartilage surface. The customized top surface of the implant hat H may e.g. be simulated based on the curvature of the cartilage immediately surrounding the area of damaged cartilage. A suitable area comprising and extending around the damaged cartilage may be selected, and the curvature of the whole area simulated in such a way that the curvature of the area which is not damaged matches the simulated curvature. A simulated healthy surface of the area of damaged cartilage may thereby be generated. The simulation may comprise an interpolation, e.g. using the Solid Works Surface Wizard or another suitable tool.”),
[0106] FIGS. 9a and 10a show an image of a three-dimensional virtual model in the form of a 3D mesh model of the cartilage and femoral bone of a knee. The 3D mesh model may be generated based on any suitable imaging methods, such as e.g. MRI. In the image of the 3D mesh model, the implant position has been marked with a circle in FIG. 9a, and two partly overlapping circles, a twin circle, in FIG. 10a. The circle, or twin circle, corresponds to the circumferential shape of the implant hat H. At least parts of the surface within this circle or twin circle comprises damaged cartilage, and possibly also damaged subchondral bone beneath the cartilage. The size and shape of the implant hat H is preferably selected based on the extent of damage, so that at least most of the damaged area is removed and replaced by the implant. Sometimes all of the surface within the circle or circles will be damaged, and some of the damaged area will not be removed, and sometimes the volume to be removed will comprise also some healthy cartilage and/or subchondral bone.”).
Regarding Claim 2, Karlsson et al teaches the system wherein the surface adjustment algorithm is a curve-fitting algorithm (See interpolation, Paragraph 0105; The simulation may comprise an interpolation, e.g. using the Solid Works Surface Wizard or another suitable tool.).
Regarding Claim 3, Karlsson et al teaches the system further comprising a display, wherein the 3D model is displayed on the display (See FIGS. 3 and 14).
Regarding Claim 4, Karlsson et al teaches the system wherein the display is an augmented reality device or virtual reality device (See FIGS. 1 and 11).
Regarding Claim 5, Karlsson et al teaches the system further comprising an X-ray imaging machine (Paragraph [0035] “… The imaging system 130 may be configured to capture or generate radiology images, such as for example X-ray images,…”).
Regarding Claims 6, 7, Karlsson et al teaches the system further comprising a manufacturing device, wherein the manufacturing device is configured to produce a physical model of at least a portion of the 3D model; wherein the manufacturing device is configured to produce a physical model of the bone aberration. (Figs. 9, 10).
Regarding Claims 8-10, Karlsson et al teaches the system of claim 7, wherein the physical model of the bone aberration is an inverse volume of a negative bone aberration; wherein the manufacturing device is an additive manufacturing device; wherein the physical model of the bone aberration comprises a medical grade polyamide ([0117] The operator then positions 1170 a virtual implant template in the three-dimensional virtual model of the joint. The virtual implant template may preferably have an implant hat H corresponding to the implant area. In the case of a circular implant, the implant hat H preferably has the shape of a cylinder. In the case of a twin implant, the implant hat H instead preferably has the shape of two partly overlapping cylinders. The positioning may be automated or manual, or partly automated and partly manual, e.g. by the processor 120 proposing a position which can then be adjusted manually by the operator. The system may e.g. automatically propose a position which the operator can then adjust manually. The virtual implant template is first placed so that the cross-section area of the implant hat H in a direction perpendicular to the implant axis A covers at least a major part of the damage. Then, the implant axis A is tilted, while the position of the cross-section area of the implant hat H in the joint is maintained. The tilt of the implant axis A is optimized by minimizing at least one of: the maximum penetration depth D.sub.max into the bone along the circumference of the implant hat H; the total volume of bone and/or cartilage to be removed for implanting the implant; and/or the surface area of the implant penetration into the bone.”).
Allowable Subject Matter
Claims 11-20 are allowed.
The following is an examiner’s statement of reasons for allowance:
None of the prior art, made of record, either singularly or in combination, teaches or fairly suggests the features presented in the limitations of Claim 11, such as “wherein the detector captures a first image of a subject orthopedic element in a first transversion position and a second image of the subject orthopedic element in a second transverse position, wherein the first transverse position is offset from the second transverse position by an offset angle; a transmitter; and a computational machine, wherein the transmitter transmits the first image and the second image of the subject orthopedic element from the radiographic imaging machine to the computational machine, and wherein the computational machine is configured to identify an area of a bone or soft tissue aberration on a 3D model of a subject orthopedic element and calculate a corrective surface, wherein the corrective surface removes the area of bone or soft tissue aberration from the 3D model of the subject orthopedic element. ”, recited by Claim 11.
Examiner notes the current invention as disclosed in the independent claims is allowed in its entirety. Each and every limitation working together in concert realizes the current claimed invention’s novelty. No single limitation alone accomplishes the allowability of the inventive independent claim(s). Rather, each and every limitation of the claim(s) and their disclosed relationships are integral.
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.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VIJAY SHANKAR whose telephone number is (571)272-7682. The examiner can normally be reached M-F 9 am- 6 pm.
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VIJAY SHANKAR
Primary Examiner
Art Unit 2624
/VIJAY SHANKAR/Primary Examiner, Art Unit 2624