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 .
Status of Claims
Claims 1-13 are pending.
Response to Arguments
Applicant’s arguments, see p.6-11, filed 01/23/2026, with respect to the rejections of Claims 1-4, 6-11, and 13 under 35 U.S.C. 103 have been fully considered but are not persuasive. Applicant argues that the cited references fail to teach the core mechanism recited in independent claims 1 and 8, namely, reconstructing a surgical posture by globally rotating an entire three-dimensional body model based on distance and angular relationships between corresponding marker points derived from a pre-scan and a single X-ray image acquired at the beginning of operation preparation. Additionally, Applicant argues that Polchin, Murphy, nor Zehavi teach the above recited limitation. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the global rotation of an entire three-dimensional body model based on distance and angular relationships between corresponding marker points derived from a pre-scan and a single X-ray image acquired at the beginning of operation preparation) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Claim 1 simply recites “…and align the second marker points to the first marker points to reconstruct the 3D model, thereby generating a three-dimensional (3D) surgical model representing a posture of the user during surgery” which is a significantly broader scoped limitation due to only requiring the aligning of the points to reconstruct the 3D model to represent posture during surgery which is taught by Zhang, Para. 25, teaches projecting the reconstructed three-dimensional femoral image with the surgical path to generate a plurality of DRR images and obtain projection pose coordinates of each of the images and extract feature points of the DRR image wherein x-ray images are acquired during the surgery in which feature points are extracted of the x-ray images and wherein automatic registration takes place between the DRR image and the X-ray image based on the feature points to output a surgical path after registration, i.e., alignment of first and second marker points being the registration of the feature points of the DRR images and the x-ray images in order to reconstruct/generate a 3D model that contains posture information of the user during a surgery, as opposed to a global rotation of an entire three-dimensional body model based on distance and angular relationships between corresponding marker points derived from a pre-scan and a single X-ray image acquired at the beginning of operation preparation. Notably, features of a rotation of the model based on relative distance and relative angles between the comparison points for reconstructing the model can be found in Claim 5 “…and after the host aligns the first reference point to the second reference point, the host rotates the set of 2D images according to relative distances and relative angles between the first comparison points and the first reference point and relative distances and relative angles between the second comparison points and the second reference point, and moves the first comparison points to respectively correspond to the second comparison points, thereby reconstructing the 3D model into the 3D surgical model” which was deemed to be allowable subject matter if incorporated into the independent claims in the Non-final Office Action mailed on 10/24/2025.
Furthermore, Applicant argues Zhang discloses three-dimensional registration models used for intraoperative navigation or image fusion and does not disclose or suggest reconstructing a surgical posture from a single X-ray image or globally rotating an entire three-dimensional body model based on marker-to-marker distance and angular relationships, as expressly required by Claims 1 and 8. Additionally, Applicant argues neither Zehavi nor Zhang discloses a host configured to globally rotate an entire three-dimensional body model based on distance and angular relationships between corresponding marker point derived from different imaging modalities, so as to reconstruct a surgical posture from a single X-ray image. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., reconstructing surgical posture from a single X-ray image or a host globally rotating an entire three-dimensional body model based on marker-to-marker distance and angular relationships between corresponding marker point derived from different imaging modalities, so as to reconstruct a surgical posture from a single X-ray image) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Claim 1 simply recites "and a host connected to the image-capturing device and the X-ray machine and configured to create a three-dimensional (3D) model of the body with the set of scanned images, and align the second marker points to the first marker points to reconstruct the 3D model, thereby generating a three-dimensional (3D) surgical model representing a posture of the user during surgery” in which a set of scanned images is recited for reconstruction and the marker points are simply aligned as opposed to a singular X-ray image being used and a global rotation of an entire three-dimensional body model based on marker distance and angles to reconstruct a surgical posture from a single X-ray image being required. Accordingly, this action is made FINAL.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6-10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Polchin et al. (US 20230390021 A1) in view of Murphy et al. (US 20150125033 A1), Zehavi et al. (US 20200411163 A1), and Zhang et al. (US 20240315776 A1).
Regarding Claim 1, Polchin teaches "A surgical positioning system comprising: positioning elements arranged on a user"; (Polchin, Para. 5, teaches a surgical marking system to register patients using real, physical marks or other such fiducials directly on the patient anatomy, i.e., surgical positioning system comprising positioning elements as the physical marks or fiducials arranged on a user);
"an image-capturing device configured to prescan a body of the user to generate a set of scanned images that include first marker points representing positions of the positioning elements"; (Polchin, Paras. 8 and 11, teaches performing patient registration wherein patient data is generated via pre-operative CT or MRI scans and wherein the surgical marking pen generates the physical mark and includes a first trackable target in which the initial patient registration registers the patient volume space of virtual positional data points to physical positional points, i.e., image-capturing device that prescans a body of the user to generate scanned images which include first marker points representing positions of the positioning elements as the trackable target being registers as representing the generated physical marks).
However, Polchin does not explicitly teach "an X-ray machine configured to photograph the body of the user at beginning of operation preparation to generate a set of two-dimensional (2D) images including second marker points representing positions of the positioning elements; and a host connected to the image-capturing device and the X-ray machine and configured to create a three-dimensional (3D) model of the body with the set of scanned images; and align the second marker points to the first marker points to reconstruct the 3D model, thereby generating a three-dimensional (3D) surgical model representing a posture of the user during surgery".
In an analogous field of endeavor, Murphy teaches "an X-ray machine configured to photograph the body of the user at beginning of operation preparation to generate a set of two-dimensional (2D) images including second marker points representing positions of the positioning elements"; (Murphy, Paras. 17 and 33, teaches receiving a preoperative 2D image being an x-ray image with placed fiducial markers wherein the fiducial markers used within a 2D image to register the locations of such markers and the corresponding structures to which they are attached within a 3D environment, i.e., x-ray machine photographs the body at the beginning of operation preparation to generate a set of 2D images which include second marker points representing positions of the positioning elements being the fiducial markers).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Polchin by including the X-ray machine that captures images of the user before surgery to generate 2D images with marker points indicating the positioning elements taught by Murphy. One of ordinary skill in the art would be motivated to combine the references since it facilitates the tracking of bone fragments during surgery (Murphy, Para. 3, teaches the motivation of combination to be to facilitate the tracking of bone fragment movement during surgery).
However, the combination of references of Polchin in view of Murphy does not explicitly teach “and a host connected to the image-capturing device and the X-ray machine and configured to create a three-dimensional (3D) model of the body with the set of scanned images; and align the second marker points to the first marker points to reconstruct the 3D model, thereby generating a three-dimensional (3D) surgical model representing a posture of the user during surgery".
In an analogous field of endeavor, Zehavi teaches "and a host connected to the image-capturing device and the X-ray machine and configured to create a three-dimensional (3D) model of the body with the set of scanned images"; (Zehavi, Paras. 48 and 51, teaches a computer controlling the adjustments to achieve the optimum result wherein 2-dimensional x-ray images are registered to the CT image set in order to generate a three-dimensional model of each vertebra including three-dimensional range of motion which the subject can achieve, i.e., host connected to CT imaging device and X-ray machine to create a 3D model of the body with the set of scanned images from both the x-ray machine and the CT images).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Polchin and Murphy by including the host being connected to an image capturing device and an X-ray machine to create a 3D model of the body with the images taught by Zehavi. One of ordinary skill in the art would be motivated to combine the references since it includes the bending limitation of the vertebra to the 3D model (Zehavi, Para. 48, teaches the motivation of combination to be to impress the bending limitation of any vertebra obtained from a 2D x-ray image onto a fully 3-dimensional representation).
However, the combination of references of Polchin in view of Murphy and Zehavi does not explicitly teach "and align the second marker points to the first marker points to reconstruct the 3D model, thereby generating a three-dimensional (3D) surgical model representing a posture of the user during surgery".
In an analogous field of endeavor, Zhang teaches "and align the second marker points to the first marker points to reconstruct the 3D model, thereby generating a three-dimensional (3D) surgical model representing a posture of the user during surgery"; (Zhang, Para. 25, teaches projecting the reconstructed three-dimensional femoral image with the surgical path to generate a plurality of DRR images and obtain projection pose coordinates of each of the images and extract feature points of the DRR image wherein x-ray images are acquired during the surgery in which feature points are extracted of the x-ray images and wherein automatic registration takes place between the DRR image and the X-ray image based on the feature points to output a surgical path after registration, i.e., alignment of first and second marker points being the registration of the feature points of the DRR images and the x-ray images in order to reconstruct/generate a 3D model that contains posture information of the user during a surgery).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Polchin, Murphy, and Zehavi by including the alignment of marker points to generate a 3D model representing posture during surgery taught by Zhang. One of ordinary skill in the art would be motivated to combine the references since it improves accuracy of registration (Zhang, Para. 93, teaches the motivation of combination to be to improve accuracy of registration of the images and has good surgical effects with few complications).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date.
Regarding Claim 2, the combination of references of Polchin in view of Murphy, Zehavi, and Zhang teaches "The surgical positioning system according to claim 1, wherein the positioning elements are attached to corresponding positions of the user"; (Polchin, Para. 145, teaches live physical fiducials are affixed to the patient in which the locations of the fiducials on the live patient may be performed using the tip of the navigated probe, i.e., positioning elements are attached to corresponding positions of the user).
Regarding Claim 3, the combination of references of Polchin in view of Murphy, Zehavi, and Zhang teaches "The surgical positioning system according to claim 1, wherein the positioning elements are arranged in corresponding positions of immutable tissues including bones or joints"; (Polchin, Para. 62, teaches patient marks including skin, bone, muscle, or tissue structure, i.e., positioning elements arranged in corresponding positions of immutable tissues including bones).
Regarding Claim 6, the combination of references of Polchin in view of Murphy, Zehavi, and Zhang teaches "The surgical positioning system according to claim 1, wherein the X-ray machine further photographs an auxiliary image of an affected area of the user, and the host is configured to combine the set of 2D images with the auxiliary image for precise positioning"; (Zhang, Para. 89, teaches two-dimensional X-ray images that are not registered during the surgery are used as anteroposterior/posteroanterior and lateral auxiliary images to display the surgical path after registration in real time, i.e., x-ray machine photographs auxiliary images of an unaffected area of the user wherein the images are combined with the auxiliary image for precise positioning through the display of the surgical path after registration using the auxiliary images).
The proposed combination as well as the motivation for combining the Polchin in view of Murphy, Zehavi, and Zhang references presented in the rejection of Claim 1, applies to claim 6. Thus, the system recited in claim 6 is met by Polchin in view of Murphy, Zehavi, and Zhang.
Regarding Claim 7, the combination of references of Polchin in view of Murphy, Zehavi, and Zhang teaches "The surgical positioning system according to claim 1, wherein the image-capturing device is a computerized tomography (CT) device, a magnetic resonance imaging (MRI) device, a positron emission tomography device, or a single-photon emission tomography device"; (Polchin, Para. 8, teaches generating patient data via pre-operative CT or MRI scans, i.e., image-capturing device is a CT or MRI device).
Claim 8 recites a method with steps corresponding to the elements of the system recited in Claim 1. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Polchin, Murphy, Zehavi, and Zhang references, presented in rejection of Claim 1, apply to this claim.
Claim 9 recites a method with steps corresponding to the elements of the system recited in Claim 2. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Polchin, Murphy, Zehavi, and Zhang references, presented in rejection of Claim 1, apply to this claim.
Claim 10 recites a method with steps corresponding to the elements of the system recited in Claim 3. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Polchin, Murphy, Zehavi, and Zhang references, presented in rejection of Claim 1, apply to this claim.
Claim 13 recites a method with steps corresponding to the elements of the system recited in Claim 6. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Polchin, Murphy, Zehavi, and Zhang references, presented in rejection of Claim 1, apply to this claim.
Claims 4 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Polchin in view of Murphy, Zehavi, Zhang, and Singh et al. (US 20190090955 A1).
Regarding Claim 4, the combination of references of Polchin in view of Murphy, Zehavi, and Zhang does not explicitly teach "The surgical positioning system according to claim 1, wherein the X-ray machine is arranged above an operating table, and when the user is lying on the operating table and ready to start operation, the X-ray machine photographs the set of 2D images".
In an analogous field of endeavor, Singh teaches "The surgical positioning system according to claim 1, wherein the X-ray machine is arranged above an operating table, and when the user is lying on the operating table and ready to start operation, the X-ray machine photographs the set of 2D images"; (Singh, FIG. 2 [320] and Paras. 13 and 75, teaches one or more imaging devices being mounted on the surgical table or integrated with the surgical lighting or other surgical equipment such as an x-ray machine wherein an imaging device has a location above the operating table wherein a virtual multidimensional model of the anatomy may be created from pre-operative 2D images, i.e., X-ray machine above an operating table that captures 2D images when the user is lying on the table ready for operation as the pre-operative images).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Polchin, Murphy, Zehavi, and Zhang by including the X-ray machine being above the operating table and captures 2D images of the user before operation when the user is on the operating table taught by Singh. One of ordinary skill in the art would be motivated to combine the references since it increases resolution and pose accuracy (Singh, Para. 102, teaches the motivation of combination to be to increase the resolution and accuracy of the pose information).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date.
Claim 11 recites a method with steps corresponding to the elements of the system recited in Claim 4. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Polchin, Murphy, Zehavi, Zhang, and Singh references, presented in rejection of Claim 4, apply to this claim.
Allowable Subject Matter
Claims 5 and 12 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. The following is the examiner’s stated reason for indication of allowable subject matter: none of the cited prior art references, alone or in combination, provides a motivation to teach the ordered combination of limitations recited in Claim 5. Regarding Claim 5, Huang, Paras. 9, 15, 83-84, and 87, teaches aligning the reference point with a center of the medical imaging apparatus to serve as an origin of the coordinate system of the medical imaging apparatus, and positions of the markers in the coordinate system of the medical imaging apparatus are calculated according to relative positions of the markers with respect to the reference point wherein positions of the markers in the coordinate system of the 3D camera is a first data set and positions of the markers in the coordinate system of the medical imaging apparatus as a second data set, i.e., align reference points, wherein pixel positions of the markers on the calibration tool are determined based on RGB images and infrared images and coordinates of the markers are determined based on the pixel positions together with depth information and wherein the calibration matrix specifically includes a rotation matrix and a translation matrix to calibrate the positions of the markers, i.e., rotation matrix rotates the images according to calculated positions including relative distance and angles between comparison points as the depth information and the translation matrix moves the markers or comparison points to calibrate the positions of the points or to ensure the respective correspondence of the points as opposed to an explicit reconstruction of a 3D model to a 3D surgical model by first aligning a primary reference point to a second primary reference point then rotating a set of 2D images based on relative distances and angles between the comparison points of the first and second points and then moving the first comparison points to correspond to the second comparison points. Claim 12 recites a method with steps corresponding to the elements of the system recited in Claim 5 and therefore contains the above indicated allowable subject matter.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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.
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/ANDREW S BUDISALICH/Examiner, Art Unit 2662
/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662