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 .
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 8/05/2025 and 9/17/2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 1-7, 10-13, and 15-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,245,825 hereinafter Harris ‘825. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant invention would be an obvious modification of the reference patent.
Regarding claim 1, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) teaches:
A system (Harris ‘825, claim 1) comprising:
a calibrated imaging machine, the calibrated imaging machine being calibrated to determine a mapping relationship between image points and corresponding space coordinates to define spatial data (Harris ‘825, claim 1);
a first image of a subject orthopedic element and a component of an orthopedic implant, the first image captured by the calibrated imaging machine, wherein the first image defines a first reference frame, and wherein the first image comprise a first set of spatial data (Harris ‘825, claim 1);
a second image of the subject orthopedic element and the component of the orthopedic implant, the second image captured by the calibrated imaging machine, wherein the second image defines a second reference frame, wherein the second image comprises a second set of spatial data, and wherein the first reference frame is offset from the second reference frame at an offset angle (Harris ‘825, claim 1); and
a computational machine, wherein the computational machine receives the first image and the second image, wherein the computational machine projects the first set of spatial data form the first image and the second set of spatial data from the second image along the offset angle to define volume data, wherein the computational machine uses a deep learning network to identify the subject orthopedic element using the volume data to define an identified orthopedic element, wherein the computational machine uses the deep learning network to identify the component of the orthopedic implant using the volume data to define an identified component of the orthopedic implant, and wherein the computational machine uses the mapping relationship of the calibrated imaging machine to output a position of the identified orthopedic element and the identified component of the orthopedic implant in three-dimensional space, and wherein the computational machine is further configured to calculate an abduction angle of the identified component of the orthopedic implant or an anteversion angle of the identified component of the orthopedic implant (Harris ‘825, claim 1).
Regarding claim 2, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) teaches:
wherein the deep learning network is further configured to identify multiple orthopedic elements and multiple components of the orthopedic implantto define multiple identified orthopedic elements and multiple identified components of the orthopedic implant (Harris ‘825, claim 2).
Regarding claim 3, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) teaches:
wherein a first identified component of the multiple identified components of the orthopedic implant is an acetabular component of a hip orthopedic implant and wherein a second identified component of the multiple identified components of the orthopedic implant is a femoral component of a hip orthopedic implant (Harris ‘825, claim 3).
Regarding claim 4, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) teaches:
wherein the identified component of the orthopedic implant is an acetabular shell and wherein the identified orthopedic element is a reamed acetabulum proximate to the acetabular shell (Harris ‘825, claim 4).
Regarding claim 5, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) teaches:
wherein the identified component of the orthopedic implant is a femoral stem and wherein the identified orthopedic element is an intramedullary canal of a femur proximate to the femoral stem (Harris ‘825, claim 5).
Regarding claim 6, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) teaches:
wherein the identified orthopedic element is modeled in three dimensions to define a modeled orthopedic element (Harris ‘825, claim 6).
Regarding claim 7, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) teaches:
further comprising a display, wherein the display displays a display image selected from the group consisting essentially of: the subject orthopedic element, a 3D model of the subject orthopedic element, a 3D model of the identified orthopedic element, the component of the orthopedic implant, a 3D model of the component of the orthopedic implant, a 3D model of the identified component of the orthopedic implant, the abduction angle of the identified component of the orthopedic implant, and the anteversion angle of the identified component of the orthopedic implant (Harris ‘825, claims 6-11).
Regarding claim 10, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) teaches:
A system (Harris ‘825, claim 12) comprising:
a calibrated imaging machine, the calibrated imaging machine being calibrated to determine a mapping relationship between image points and corresponding space coordinates to define spatial data (Harris ‘825, claim 12);
a first image of a subject orthopedic element, the first image captured by the calibrated imaging machine, wherein the first image defines a first reference frame, and wherein the first image comprise a first set of spatial data (Harris ‘825, claim 12);
a second image of the subject orthopedic element, the second image captured by the calibrated imaging machine, wherein the second image defines a second reference frame, wherein the second image comprises a second set of spatial data, and wherein the first reference frame is offset from the second reference frame at an offset angle (Harris ‘825, claim 12); and
a computational machine, wherein the computational machine receives the first image and the second image, wherein the computational machine projects the first set of spatial data form the first image and the second set of spatial data from the second image along the offset angle to define volume data, wherein the computational machine uses a deep learning network to identify the subject orthopedic element using the volume data to define an identified orthopedic element, and wherein the computational machine uses the mapping relationship of the calibrated imaging machine to output size dimensions of the identified orthopedic element in three-dimensional space (Harris ‘825, claim 12); and
a database, the database comprising a list of types of components of an orthopedic implant and a list of associated component size dimensions for each type of component in the list of types of components of the orthopedic implant, wherein the computational machine is further configured to select a recommended type of a component of an orthopedic implant based on the size dimensions of the identified orthopedic element in three dimensional space (Harris ‘825, claim 12).
Regarding claim 11, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) teaches:
wherein the identified orthopedic element is the internal geometry of a bone before or after reaming or before or after broaching (Harris ‘825, claim 13).
Regarding claim 12, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) teaches:
wherein the computational machine is configured to run a best fit algorithm to select the recommended component of the orthopedic implant based on the size dimensions of the identified orthopedic element (Harris ‘825, claim 14).
Regarding claim 13, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) teaches:
further comprising a display, wherein the display displays a display image selected from the group consisting essentially of: the subject orthopedic element, a 3D model of the subject orthopedic element, a 3D model of the identified orthopedic element, the size dimensions of the identified orthopedic element, and therecommended type of component of the orthopedic implant based on the size dimensions of the identified orthopedic element in three dimensional space (Harris ‘825, claims 6-11).
Regarding claim 15, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) teaches:
A system for determining the size of a component of an orthopedic implant to be surgically implanted into a patient (Harris ‘825, claim 15), the system comprising:
a calibrated imaging machine, the calibrated imaging machine being calibrated to determine a mapping relationship between image points and corresponding space coordinates to define spatial data (Harris ‘825, claim 15);
a first image of a subject orthopedic element, the first image captured by the calibrated imaging machine, wherein the first image defines a first reference frame, and wherein the first image comprise a first set of spatial data (Harris ‘825, claim 15);
a second image of the subject orthopedic element, the second image captured by the calibrated imaging machine, wherein the second image defines a second reference frame, wherein the second image comprises a second set of spatial data, and wherein the first reference frame is offset from the second reference frame at an offset angle (Harris ‘825, claim 15); and
a computational machine wherein the computational machine receives the first image and the second image, wherein the computational machine projects the first set of spatial data form the first image and the second set of spatial data from the second image along the offset angle to define volume data, wherein the computational machine uses a deep learning network to identify the subject orthopedic element using the volume data to define an identified orthopedic element, and wherein the computational machine uses the mapping relationship of the calibrated imaging machine to output size dimensions of the identified orthopedic element in three-dimensional space (Harris ‘825, claim 15); and
a database, the database comprising a list of components of an orthopedic implant and a list of associated component size dimensions for each component in the list of components of the endoprosthetic implant, wherein the computational machine is further configured to select a recommended size of a component of an orthopedic implant from the list of associated component size dimensions based on the output size dimension of the identified orthopedic element in three dimensional space (Harris ‘825, claim 15).
Regarding claim 16, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) teaches:
wherein the identified orthopedic element is the internal geometry of a bone before or after reaming or before or after broaching (Harris ‘825, claim 16).
Regarding claim 17, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) teaches:
wherein the computational machine is configured to run a best fit algorithm to select the recommended component of the orthopedic implant based on the output size dimensions of the identified orthopedic element (Harris ‘825, claim 17).
Regarding claim 18, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) teaches:
further comprising a display, wherein the display displays a display image selected from the group consisting essentially of: the subject orthopedic element, a 3D model of the subject orthopedic element, a 3D model of the identified orthopedic element, the size dimensions of the identified orthopedic element, and the recommended size of the component of the orthopedic implant based on the output size dimensions of the identified orthopedic element in three dimensional space (Harris ‘825, claims 6-11).
Claims 8-9, 14, and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,245,825 hereinafter Harris ‘825, in view of Abe et al. (U.S. Pat. No. 11376078) hereinafter Abe. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant invention would be an obvious modification of the reference patent.
Regarding claim 8, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) further fails to teach:
wherein the display is an augmented reality device or a virtual reality device.
However, the analogous art of Abe of a surgery assistance system with augmented reality display system (abstract) teaches:
wherein the display is an augmented reality device or a virtual reality device (Abe, claims 1-3, augmented reality image of he captured image overlapped with the orthopedic procedure element).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the orthopedic implant spatial positioning and recommendation system of Harris ‘825 to incorporate the augmented reality image as taught by Abe because augmented reality imagery provides real-time positional guidance based upon visual placement of objects within 3D space (Abe, col 9, line 10-35). This leads to clear delivery of position guidance and more efficient procedures.
Regarding claim 9, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) further fails to teach:
wherein the display image is superimposed on the subject orthopedic element and locked to one or more features of the subject orthopedic element
However, the analogous art of Abe of a surgery assistance system with augmented reality display system (abstract) teaches:
wherein the display image is superimposed on the subject orthopedic element and locked to one or more features of the subject orthopedic element (Abe, claims 1-3, augmented reality image of he captured image overlapped with the orthopedic procedure element and therefore locked to features on the superimposed image).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the orthopedic implant spatial positioning and recommendation system of Harris ‘825 and Abe to incorporate the augmented reality image as taught by Abe because augmented reality imagery provides real-time positional guidance based upon visual placement of objects within 3D space (Abe, col 9, line 10-35). This leads to clear delivery of position guidance and more efficient procedures.
Regarding claim 14, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) further fails to teach:
wherein the display is an augmented reality device or a virtual reality device, and wherein the display image is superimposed on the subject orthopedic element and locked to one or more features of the subject orthopedic element.
However, the analogous art of Abe of a surgery assistance system with augmented reality display system (abstract) teaches:
wherein the display is an augmented reality device or a virtual reality device, and wherein the display image is superimposed on the subject orthopedic element and locked to one or more features of the subject orthopedic element (Abe, claims 1-3, augmented reality image of he captured image overlapped with the orthopedic procedure element and therefore locked to features on the superimposed image).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the orthopedic implant spatial positioning and recommendation system of Harris ‘825 to incorporate the augmented reality image as taught by Abe because augmented reality imagery provides real-time positional guidance based upon visual placement of objects within 3D space (Abe, col 9, line 10-35). This leads to clear delivery of position guidance and more efficient procedures.
Regarding claim 19, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) further fails to teach:
wherein the display is an augmented reality device or a virtual reality device.
However, the analogous art of Abe of a surgery assistance system with augmented reality display system (abstract) teaches:
wherein the display is an augmented reality device or a virtual reality device (Abe, claims 1-3, augmented reality image of he captured image overlapped with the orthopedic procedure element).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the orthopedic implant spatial positioning and recommendation system of Harris ‘825 to incorporate the augmented reality image as taught by Abe because augmented reality imagery provides real-time positional guidance based upon visual placement of objects within 3D space (Abe, col 9, line 10-35). This leads to clear delivery of position guidance and more efficient procedures.
Regarding claim 20, reference patent Harris ‘825 (U.S. Pat. No. 12,245,825) further fails to teach:
wherein the display image is superimposed on the subject orthopedic element and locked to one or more features of the subject orthopedic element
However, the analogous art of Abe of a surgery assistance system with augmented reality display system (abstract) teaches:
wherein the display image is superimposed on the subject orthopedic element and locked to one or more features of the subject orthopedic element (Abe, claims 1-3, augmented reality image of he captured image overlapped with the orthopedic procedure element and therefore locked to features on the superimposed image).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the orthopedic implant spatial positioning and recommendation system of Harris ‘825 and Abe to incorporate the augmented reality image as taught by Abe because augmented reality imagery provides real-time positional guidance based upon visual placement of objects within 3D space (Abe, col 9, line 10-35). This leads to clear delivery of position guidance and more efficient procedures.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The claims are currently rejected as indicated above, and thus are not currently in condition for allowance.
The claims are similar to the parent case, issued patent U.S. Pat. No. 12,245,825. The claims are otherwise similar in scope and contain the subject matter found allowable in the parent application, in that they include an orthopedic element position determining and component in space determining feature. The claims form a nonobvious combination of features that differentiate from the closest prior art references, in light of both the similar features to the parent case, as well as the additional subject matter of the present application.
Conclusion
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/SEAN A FRITH/Primary Examiner, Art Unit 3798