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
This communication is in response to the Application Filed on 02/03/2025.
Claims 1–20 are pending in this application.
Drawings
The drawings filed on 02/03/2025 are accepted by the Examiner.
Claim Objections
Claim 19 is objected to because of the following informalities:
Claim 19 depends on claim 19, perhaps this ought to depend on claim 18. Appropriate correction is required.
Claim 19 line 6 recites the limitations “…the lease total surface area…”, perhaps this ought to be “…the least total surface area…”. For the purpose of examination, the Examiner is interpreting it as “least”. Appropriate correction is required.
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 1, 14 and 20 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.
Regarding claims 1, 14 and 20, the phrase "segmenting the patient input data" renders the claim indefinite because it’s not clear how the segmenting the patient input data is used in the following limitations of “generating a three-dimensional model of the patient anatomy”. In fact the two other limitations of “collecting” and “determining” also fail to relate to the “segmenting” limitation. It seems that the segmentation limitation is a standalone limitation and not directly tied to other limitations of the claims. For the purpose of examination, the Examiner interprets segmenting of the patient data as segmenting X-ray images of the bone.
Dependent claims 2–13 and 15–19 are rejected for failing to remedy the ambiguity of their respective independent claims
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) 1–6, 14–16 and 20 are rejected under 35 U.S.C. 102 as being unpatentable over Karade et al. (US 20210007806 A1, hereafter, "Karade").
Regarding claim 1, Karade discloses a process for identifying a deformity (See Karade, [Abstract], A method for providing 3-dimensional deformity corrections for bones), comprising:
receiving patient input data showing patient anatomy (See Karade, ¶ [0075], As shown in FIG. 1, an X-ray inputter 12 provides X-ray images for conversion. Inputter 12 may acquire the X-ray images through known procedures with conventional single-view X-ray imaging equipment. Orthogonal X-ray images from biplanar imaging may also be used. Such X-ray images from inputter 12 may include medial-lateral and anterior-posterior views. ¶ [0086], For a tibia bone such as that shown in FIG. 3A, a contour of the bone in at least one view (ML or AP) of X-ray image, the anatomical regions will be tibial proximal condyle, tibial shaft, and tibial distal condyle. See also [Figure 3A]
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Note: the examiner is interpreting the input data as acquiring the X-ray images as seen in FIG. 16
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Examiner interprets the anatomical regions as the anatomy that is shown in the X-ray);
segmenting the patient input data (See Karade, ¶ [0096], A 3D surface model can be created using techniques such as MIMICs through segmentation of all the slices images of CT scan);
generating a three-dimensional model of the patient anatomy (See Karade, ¶ [0085, A 2D Anatomical Value may include: anatomical landmarks-2D positions of unique anatomical features identified on the final X-ray image on the basis anatomical regions; and anatomical parameters—values of geometric parameters like lengths and angles calculated based on anatomical landmarks to be used for 3D reconstruction);
collecting one or more measurements from the three-dimensional model of the patient anatomy (See Karade, ¶ [0121], In the landmark identification process, landmarks are calculated based on the standard directions of bone's ACS. In the given ACS (initially estimated above), the following 3D landmarks are calculated. See also [FIG. 18]
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Note: Examiner interprets collecting measurements as calculating landmarks); and
determining if a deformity is present in the patient anatomy (See Karade, ¶ [0214], A deformed bone can have any combination of the three kind of bending deformities explained above. ¶ [0217], Calculating correction based on pJRL and dJRL. ¶ [0218], Correction-translation<Thr. ¶ [0219], Correction-rotation>Thr. ¶ [0220], Apply osteotomy correction. Note: the deformity is based on the correction angle [Figure 26]
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).
Regarding claim 2, Karade discloses the process of claim 1, wherein the patient anatomy includes a tibia of a patient (See Karade, ¶ [0083], For example, a femur and tibia bone for knee replacement or tibial osteotomy surgery may be outlined).
Regarding claim 3, Karade discloses the process of claim 2, further comprising:
identifying a proximal portion of the tibia in the three-dimensional model (See Karade, ¶ [0180, The 3D model of deformed bone is in the form of mesh (objects with vertices and faces) with triangular elements. The vertices of this mesh represent the points on the surface of the bone (femur or tibia or the like). ¶ [0213], repositioning of distal bone segment with respect to proximal bone segment which includes rotation of distal segment about CORA by correction angle followed by shift of distal bone segment by the magnitude and along the direction of translation shift vector. Note: this determines the proximal segment); and
identifying a distal portion of the tibia in the three-dimensional model (See Karade, ¶ [0180], The 3D model of deformed bone is in the form of mesh (objects with vertices and faces) with triangular elements. The vertices of this mesh represent the points on the surface of the bone (femur or tibia or the like). ¶ [0213], repositioning of distal bone segment with respect to proximal bone segment which includes rotation of distal segment about CORA by correction angle followed by shift of distal bone segment by the magnitude and along the direction of translation shift vector. Note: this also determines the distal segment).
Regarding claim 4, Karade discloses the process of claim 3, further comprising: identifying one or more anatomic or geometric planes relative to the tibia in the three- dimensional model (See Karade, ¶ [0189], The extent of each of the deformities can be calculated by two deformity reference axis defined in a 3D plane called as deformity plane. Note: Examiner is interpreting the deformity plane as the geometric plane).
Regarding claim 5, Karade discloses the process of claim 4, further comprising:
identifying one or more points on the proximal portion of the tibia in the three- dimensional model (See Karade, ¶ [0180], The 3D model of deformed bone is in the form of mesh (objects with vertices and faces) with triangular elements. The vertices of this mesh represent the points on the surface of the bone (femur or tibia or the like). ¶ [0213], repositioning of distal bone segment with respect to proximal bone segment which includes rotation of distal segment about CORA by correction angle followed by shift of distal bone segment by the magnitude and along the direction of translation shift vector. Note: this determines the proximal segment); and
identifying one or more points on the distal portion of the tibia in the three-dimensional model (See Karade, ¶ [0180, The 3D model of deformed bone is in the form of mesh (objects with vertices and faces) with triangular elements. The vertices of this mesh represent the points on the surface of the bone (femur or tibia or the like). ¶ [0213], repositioning of distal bone segment with respect to proximal bone segment which includes rotation of distal segment about CORA by correction angle followed by shift of distal bone segment by the magnitude and along the direction of translation shift vector. Note: this also determines the distal segment).
Regarding claim 6, Karade discloses the process of claim 5, wherein the collecting one or more measurements from the three-dimensional model of the patient anatomy (See Karade, ¶ [0121], In the landmark identification process, landmarks are calculated based on the standard directions of bone's ACS. In the given ACS (initially estimated above), the following 3D landmarks are calculated. See also [FIG. 18]
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Note: Examiner interprets collecting measurements as calculating landmarks) further comprises:
determining the position of the one or more points on the proximal portion of the tibia relative to the one or more anatomic landmarks or geometric planes in the three-dimensional model (See Karade, ¶ [0180], The 3D model of deformed bone is in the form of mesh (objects with vertices and faces) with triangular elements. The vertices of this mesh represent the points on the surface of the bone (femur or tibia or the like). ¶ [0181], The anatomical landmarks are vertices of deformed bone which represent unique bony features. ¶ [0212], resection of a bone through resection plane passing through the pivot point, resulting in proximal bone segment and distal segment); and
determining the position of the one or more points on the distal portion of the tibia relative to the one or more anatomic landmarks or geometric planes in the three-dimensional model (See Karade, ¶ [0180], The 3D model of deformed bone is in the form of mesh (objects with vertices and faces) with triangular elements. The vertices of this mesh represent the points on the surface of the bone (femur or tibia or the like). ¶ [0181], The anatomical landmarks are vertices of deformed bone which represent unique bony features. ¶ [0212], resection of a bone through resection plane passing through the pivot point, resulting in proximal bone segment and distal segment).
Regarding claim 14, Karade discloses a process for determining an optimal osteotomy angle (See Karade, ¶ [0083], For example, a femur and tibia bone for knee replacement or tibial osteotomy surgery may be outlined), comprising:
receiving patient input data showing patient anatomy (See Karade, ¶ [0075], As shown in FIG. 1, an X-ray inputter 12 provides X-ray images for conversion. Inputter 12 may acquire the X-ray images through known procedures with conventional single-view X-ray imaging equipment. Orthogonal X-ray images from biplanar imaging may also be used. Such X-ray images from inputter 12 may include medial-lateral and anterior-posterior views. ¶ [0086], For a tibia bone such as that shown in FIG. 3A, a contour of the bone in at least one view (ML or AP) of X-ray image, the anatomical regions will be tibial proximal condyle, tibial shaft, and tibial distal condyle. See also [Figure 3A]
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Note: the examiner is interpreting the input data as acquiring the X-ray images as seen in FIG. 16
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Examiner interprets the anatomical regions as the anatomy that is shown in the X-ray);
segmenting the patient input data (See Karade, ¶ [0096], A 3D surface model can be created using techniques such as MIMICs through segmentation of all the slices images of CT scan);
generating a three-dimensional model of the patient anatomy (See Karade, ¶ [0085, A 2D Anatomical Value may include: anatomical landmarks-2D positions of unique anatomical features identified on the final X-ray image on the basis anatomical regions; and anatomical parameters—values of geometric parameters like lengths and angles calculated based on anatomical landmarks to be used for 3D reconstruction);
identifying one or more anatomic structures in the three-dimensional model (See Karade, ¶ [0120], FIG. 3C illustrates these anatomical regions as corresponding to the regions distinguished in the contour of an X-ray image. Anatomical landmarks identified based on anatomical regions of the template may be the same as the anatomical landmarks identified based on anatomical regions of the contour. See also [FIG. 18]
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Note: Examiner interprets anatomic structure as the anatomic region);
identifying one or more anatomic landmarks on the one or more anatomic structures in the three-dimensional model (See Karade, ¶ [0120], FIG. 3C illustrates these anatomical regions as corresponding to the regions distinguished in the contour of an X-ray image. Anatomical landmarks identified based on anatomical regions of the template may be the same as the anatomical landmarks identified based on anatomical regions of the contour. See also [FIG. 18]
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);
determining a desired correction to be achieved from an osteotomy (See Karade, ¶ [0223], Apply torsional correction. ¶ [0224], For this, the deformity reference axes for any one of the joint deformity (consequence of choosing any one joint will result in shifting of correction to other joint.) will be recalculated in the following way, ..., For tibia, reference axis 1 will be calculated in the AP plane at an angle MPTA (ideal) with the joint line measured from medial side passing through proximal joint centre and reference axis 2 will be calculated in the AP plane at an angle LDTA (ideal) with the joint line measured from lateral side passing through distal joint centre); and
determining an optimal osteotomy angle (See Karade, ¶ [0224], For tibia, reference axis 1 will be calculated in the AP plane at an angle MPTA (ideal) with the joint line measured from medial side passing through proximal joint centre and reference axis 2 will be calculated in the AP plane at an angle LDTA (ideal) with the joint line measured from lateral side passing through distal joint centre. Note: Examiner interpreting the angle LDTA (IDEAL) as the osteotomy angle).
Regarding claim 15, Karade discloses the process of claim 14, wherein the desired correction comprises a desired rotational correction of a distal portion of a tibia relative to a proximal portion of the tibia (See Karade, ¶ [0213], repositioning of distal bone segment with respect to proximal bone segment which includes rotation of distal segment about CORA by correction angle followed by shift of distal bone segment by the magnitude and along the direction of translation shift vector).
Regarding claim 16, Karade discloses the process of claim 15, further comprising: determining an optimal osteotomy point, wherein the optimal osteotomy point is positioned along the long axis of the tibia (See Karade, ¶ [0213], The FIGS. 25, 26, and 27 shows a typical deformity correction. The deformity correction parameters are calculated using deformity reference axis explained earlier. ¶ [0189], The extent of each of the deformities can be calculated by two deformity reference axis defined in a 3D plane called as deformity plane).
Regarding claim 20, Karade discloses a process for identifying a deformity (See Karade, [Abstract], A method for providing 3-dimensional deformity corrections for bones), comprising:
receiving patient input data showing patient anatomy (See Karade, ¶ [0075], As shown in FIG. 1, an X-ray inputter 12 provides X-ray images for conversion. Inputter 12 may acquire the X-ray images through known procedures with conventional single-view X-ray imaging equipment. Orthogonal X-ray images from biplanar imaging may also be used. Such X-ray images from inputter 12 may include medial-lateral and anterior-posterior views. ¶ [0086], For a tibia bone such as that shown in FIG. 3A, a contour of the bone in at least one view (ML or AP) of X-ray image, the anatomical regions will be tibial proximal condyle, tibial shaft, and tibial distal condyle. See also [Figure 3A]
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Note: the examiner is interpreting the input data as acquiring the X-ray images as seen in FIG. 16
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Examiner interprets the anatomical regions as the anatomy that is shown in the X-ray);
segmenting the patient input data (See Karade, ¶ [0096], A 3D surface model can be created using techniques such as MIMICs through segmentation of all the slices images of CT scan);
generating a three-dimensional model of the patient anatomy (See Karade, ¶ [0085, A 2D Anatomical Value may include: anatomical landmarks-2D positions of unique anatomical features identified on the final X-ray image on the basis anatomical regions; and anatomical parameters—values of geometric parameters like lengths and angles calculated based on anatomical landmarks to be used for 3D reconstruction);
identifying one or more points on the patient anatomy (See Karade, ¶ [0121], In the landmark identification process, landmarks are calculated based on the standard directions of bone's ACS. In the given ACS (initially estimated above), the following 3D landmarks are calculated. See also [FIG. 18]
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);
collecting one or more measurements incorporating the one or more points on the patient anatomy (See Karade, ¶ [0181], The anatomical landmarks are vertices of deformed bone which represent unique bony features. This can be identified manually with 3D user interface or automatically which are already published in literature);
determining, based on the one or more measurements, if a deformity is present in the patient anatomy (See Karade, ¶ [0214], A deformed bone can have any combination of the three kind of bending deformities explained above. ¶ [0217], Calculating correction based on pJRL and dJRL. ¶ [0218], Correction-translation<Thr. ¶ [0219], Correction-rotation>Thr. ¶ [0220], Apply osteotomy correction. Note: the deformity is based on the correction angle [Figure 26]
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recommending one or more actions to correct the deformity of the patient anatomy (See Karade, ¶ [0223], Apply torsional correction. ¶ [0224], One of the joint deformity will be corrected using the deformity reference axes as described earlier (first cut) and the other will be calculated using the new reference axes calculated above (second cut). Hence, this will result in two bone cuts. In most of the cases, this will also lead to correction of shaft deformity).
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 non-obviousness.
Claim(s) 7–13 are rejected under 35 U.S.C. 103 as being unpatentable over Karade et al. (US 20210007806 A1, hereafter, "Karade") in view of Plessers et al. (US 20220054197 A1, hereafter, "Plessers").
Regarding claim 7, Karade discloses the process of claim 6, further comprising: [calculating a difference between the determined position of the one or more points on the proximal portion of the tibia relative to the one or more anatomic landmarks or geometric planes in the three-dimensional model and a normal position of the one or more points on the proximal portion of the tibia relative to the one or more anatomic landmarks or geometric planes].
However, Karade fails to teach calculating a difference between the determined position of the one or more points on the proximal portion of the tibia relative to the one or more anatomic landmarks or geometric planes in the three-dimensional model and a normal position of the one or more points on the proximal portion of the tibia relative to the one or more anatomic landmarks or geometric planes.
Plessers, working in the same field of endeavor, teaches: calculating a difference between the determined position of the one or more points on the proximal portion of the tibia relative to the one or more anatomic landmarks (See Plessers, ¶ [0261], In some embodiments of method 2700, determining the subset of topological regions from the plurality of topological regions to use for fitting the statistical shape model to the three-dimensional anatomy model further comprises: selecting a first topological region from the plurality of topological regions; fitting the statistical shape model to the three-dimensional anatomy model based only on the first topological region; and calculating a first fit error based on a first fit of the statistical shape model based on the first topological region. [0262] In some embodiments of method 2700, the first fit error is calculated as a root mean square error (RMSE) between a plurality of points on the statistical shape model and a plurality of corresponding points on the three-dimensional anatomy model. Note: Examiner is interpreting the fit error are the difference between the points) or geometric planes in the three-dimensional model and a normal position of the one or more points on the proximal portion of the tibia relative to the one or more anatomic landmarks or geometric planes (Note: Examiner only needs to teach one).
Thus, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Karade’s reference to calculating a difference between the determined position of the one or more points on the proximal portion of the tibia relative to the one or more anatomic landmarks or geometric planes in the three-dimensional model and a normal position of the one or more points on the proximal portion of the tibia relative to the one or more anatomic landmarks or geometric planes based on the method of Plessers’s reference. The suggestion/motivation would have been to automate and accurate quantify defects for surgical planning (See Plessers, ¶ [0002–0004]).
Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Plessers with Karade to obtain the invention as specified in claim 7.
Regarding claim 8, Karade in view of Plessers teaches the process of claim 7, further comprising: [calculating a difference between the determined position of the one or more points on the distal portion of the tibia relative to the one or more anatomic landmarks or geometric planes in the three-dimensional model and a normal position of the one or more points on the distal portion of the tibia relative to the one or more anatomic landmarks or geometric planes].
However, Karade fails to teach calculating a difference between the determined position of the one or more points on the distal portion of the tibia relative to the one or more anatomic landmarks or geometric planes in the three-dimensional model and a normal position of the one or more points on the distal portion of the tibia relative to the one or more anatomic landmarks or geometric planes.
Plessers, working in the same field of endeavor, teaches: calculating a difference between the determined position of the one or more points on the distal portion of the tibia relative to the one or more anatomic landmarks (See Plessers, ¶ [0261], In some embodiments of method 2700, determining the subset of topological regions from the plurality of topological regions to use for fitting the statistical shape model to the three-dimensional anatomy model further comprises: selecting a first topological region from the plurality of topological regions; fitting the statistical shape model to the three-dimensional anatomy model based only on the first topological region; and calculating a first fit error based on a first fit of the statistical shape model based on the first topological region. [0262] In some embodiments of method 2700, the first fit error is calculated as a root mean square error (RMSE) between a plurality of points on the statistical shape model and a plurality of corresponding points on the three-dimensional anatomy model. Note: Examiner is interpreting the fit error are the difference between the points) or geometric planes in the three-dimensional model and a normal position of the one or more points on the distal portion of the tibia relative to the one or more anatomic landmarks or geometric planes (Note: Examiner only needs to teach one).
Thus, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Karade’s reference calculating a difference between the determined position of the one or more points on the distal portion of the tibia relative to the one or more anatomic landmarks or geometric planes in the three-dimensional model and a normal position of the one or more points on the distal portion of the tibia relative to the one or more anatomic landmarks or geometric planes based on the method of Plessers’s reference. The suggestion/motivation would have been to automate and accurate quantify defects for surgical planning (See Plessers, ¶ [0002–0004]).
Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Plessers with Karade to obtain the invention as specified in claim 8.
Regarding claim 9, Karade in view of Plessers teaches the process of claim 8, wherein the determining if a deformity is present in the patient anatomy (See Karade, ¶ [0179], This invention's 3D deformity correction system and method for elongate bones requires information in terms of anatomical regions, anatomical axes, anatomical landmarks, and anatomical parameters of a 3D deformed bone) further comprises: [determining, based on the calculated difference between the determined position of the one or more points on the proximal portion of the tibia relative to the one or more anatomic landmarks or geometric planes in the three-dimensional model and the normal position of the one or more points on the proximal portion of the tibia relative to the one or more anatomic landmarks or geometric planes, if a deformity is present in the proximal portion of the tibia].
However, Karade fails to teach determining, based on the calculated difference between the determined position of the one or more points on the proximal portion of the tibia relative to the one or more anatomic landmarks or geometric planes in the three-dimensional model and the normal position of the one or more points on the proximal portion of the tibia relative to the one or more anatomic landmarks or geometric planes, if a deformity is present in the proximal portion of the tibia.
Plessers, working in the same field of endeavor, teaches: determining, based on the calculated difference between the determined position of the one or more points on the proximal portion of the tibia relative to the one or more anatomic landmarks (See Plessers, ¶ [0261], In some embodiments of method 2700, determining the subset of topological regions from the plurality of topological regions to use for fitting the statistical shape model to the three-dimensional anatomy model further comprises: selecting a first topological region from the plurality of topological regions; fitting the statistical shape model to the three-dimensional anatomy model based only on the first topological region; and calculating a first fit error based on a first fit of the statistical shape model based on the first topological region. [0262] In some embodiments of method 2700, the first fit error is calculated as a root mean square error (RMSE) between a plurality of points on the statistical shape model and a plurality of corresponding points on the three-dimensional anatomy model) or geometric planes in the three-dimensional model and the normal position of the one or more points on the proximal portion of the tibia relative to the one or more anatomic landmarks or geometric planes (Note: Examiner only needs to teach one), if a deformity is present in the proximal portion of the tibia (See Plessers, ¶ [0193], Then, a statistical shape model of a healthy anatomy (e.g., a healthy jaw) may be fitted to the three-dimensional surface model to identify healthy and damaged portions of the patient's anatomy (e.g., a damaged portion of the patient's jaw)).
Thus, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Karade’s reference determining, based on the calculated difference between the determined position of the one or more points on the proximal portion of the tibia relative to the one or more anatomic landmarks or geometric planes in the three-dimensional model and the normal position of the one or more points on the proximal portion of the tibia relative to the one or more anatomic landmarks or geometric planes, if a deformity is present in the proximal portion of the tibia based on the method of Plessers’s reference. The suggestion/motivation would have been to automate and accurate quantify defects for surgical planning (See Plessers, ¶ [0002–0004]).
Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Plessers with Karade to obtain the invention as specified in claim 9.
Regarding claim 10, Karade in view of Plessers teaches the process of claim 9, wherein the determining if a deformity is present in the patient anatomy (See Karade, ¶ [0179], This invention's 3D deformity correction system and method for elongate bones requires information in terms of anatomical regions, anatomical axes, anatomical landmarks, and anatomical parameters of a 3D deformed bone) further comprises: [determining, based on the calculated difference between the determined position of the one or more points on the distal portion of the tibia relative to the one or more anatomic landmarks or geometric planes in the three-dimensional model and the normal position of the one or more points on the distal portion of the tibia relative to the one or more anatomic landmarks or geometric planes, if a deformity is present in the proximal portion of the tibia].
However, Karade fails to teach determining, based on the calculated difference between the determined position of the one or more points on the distal portion of the tibia relative to the one or more anatomic landmarks or geometric planes in the three-dimensional model and the normal position of the one or more points on the distal portion of the tibia relative to the one or more anatomic landmarks or geometric planes, if a deformity is present in the proximal portion of the tibia.
Plessers, working in the same field of endeavor, teaches: determining, based on the calculated difference between the determined position of the one or more points on the distal portion of the tibia relative to the one or more anatomic landmarks (See Plessers, ¶ [0261], In some embodiments of method 2700, determining the subset of topological regions from the plurality of topological regions to use for fitting the statistical shape model to the three-dimensional anatomy model further comprises: selecting a first topological region from the plurality of topological regions; fitting the statistical shape model to the three-dimensional anatomy model based only on the first topological region; and calculating a first fit error based on a first fit of the statistical shape model based on the first topological region. [0262] In some embodiments of method 2700, the first fit error is calculated as a root mean square error (RMSE) between a plurality of points on the statistical shape model and a plurality of corresponding points on the three-dimensional anatomy model) or geometric planes in the three-dimensional model and the normal position of the one or more points on the distal portion of the tibia relative to the one or more anatomic landmarks or geometric planes (Note: Examiner only needs to teach one), if a deformity is present in the proximal portion of the tibia (See Plessers, ¶ [0193], Then, a statistical shape model of a healthy anatomy (e.g., a healthy jaw) may be fitted to the three-dimensional surface model to identify healthy and damaged portions of the patient's anatomy (e.g., a damaged portion of the patient's jaw)).
Thus, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Karade’s reference determining, based on the calculated difference between the determined position of the one or more points on the distal portion of the tibia relative to the one or more anatomic landmarks or geometric planes in the three-dimensional model and the normal position of the one or more points on the distal portion of the tibia relative to the one or more anatomic landmarks or geometric planes, if a deformity is present in the proximal portion of the tibia based on the method of Plessers’s reference. The suggestion/motivation would have been to automate and accurate quantify defects for surgical planning (See Plessers, ¶ [0002–0004]).
Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Plessers with Karade to obtain the invention as specified in claim 10.
Regarding claim 11, Karade in view of Plessers teaches the process of claim 10, further comprising: classifying a deformity identified in the proximal portion of the tibia (See Karade, ¶ [0183], The deformity of any elongate bone can be broadly classified into two types: [0184] 1. Torsional deformity which occurs due to relative twisting between proximal and distal region of the bone; and [0185] 2. Bending deformity which occurs due to relative bending between proximal and distal region of the bone).
Regarding claim 12, Karade in view of Plessers teaches the process of claim 10, further comprising: classifying a deformity identified in the distal portion of the tibia (See Karade, ¶ [0183], The deformity of any elongate bone can be broadly classified into two types: [0184] 1. Torsional deformity which occurs due to relative twisting between proximal and distal region of the bone; and [0185] 2. Bending deformity which occurs due to relative bending between proximal and distal region of the bone).
Regarding claim 13, Karade in view of Plessers teaches the process of claim 12, further comprising: recommending, based on the deformity identified in the distal portion of the tibia, one or more corrective procedures to be performed to the tibia (See Karade, ¶ [0223], Apply torsional correction ¶ [0224], For tibia, reference axis 1 will be calculated in the AP plane at an angle MPTA (ideal) with the joint line measured from medial side passing through proximal joint centre and reference axis 2 will be calculated in the AP plane at an angle LDTA (ideal) with the joint line measured from lateral side passing through distal joint centre).
Claim(s) 17–19 are rejected under 35 U.S.C. 103 as being unpatentable over Karade et al. (US 20210007806 A1, hereafter, "Karade") in view of Lynch (US 20240189034 A1, hereafter, "Lynch") further in view of Lang (US 20200138518 A1, hereafter, "Lang").
Regarding claim 17, Karade discloses the process of claim 16, wherein determining an optimal osteotomy angle (See Karade, ¶ [0224], For tibia, reference axis 1 will be calculated in the AP plane at an angle MPTA (ideal) with the joint line measured from medial side passing through proximal joint centre and reference axis 2 will be calculated in the AP plane at an angle LDTA (ideal) with the joint line measured from lateral side passing through distal joint centre. Note: Examiner interpreting the angle LDTA (IDEAL) as the osteotomy angle) comprises: [determining, based on the osteotomy point, total surface area of overhang and underhang resulting from rotation of the distal portion of the tibia relative to the proximal portion of the tibia for an osteotomy performed at a first osteotomy angle across the optimal osteotomy point].
However, Karade fails to teach determining, based on the osteotomy point, total surface area of overhang and underhang resulting from rotation of the distal portion of the tibia relative to the proximal portion of the tibia for an osteotomy performed at a first osteotomy angle across the optimal osteotomy point.
Lynch, working in the same field of endeavor, teaches: resulting from rotation of the distal portion of the tibia relative to the proximal portion of the tibia for an osteotomy performed at a first osteotomy angle across the optimal osteotomy point (See Lynch, ¶ [0072], In specific embodiments, the bone segments can be rotated while bisected. While the bone is bisected into two separate solid bodies, the proximal and distal end can be coronally rotated to more accurately model a certain bone deformity. ¶ [0080], In specific embodiments the system can be used to generate patient specific and/or anatomic specific implants, cut guides, or other surgical implements using the nonconforming bone model (e.g., a nonconforming bone surface used to produce an anatomic patient specific surgical implement). See also [FIG. 21]).
Thus, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Karade’s reference to resulting from rotation of the distal portion of the tibia relative to the proximal portion of the tibia for an osteotomy performed at a first osteotomy angle across the optimal osteotomy point based on the method of Lynch’s reference. The suggestion/motivation would have been to improve surgical planning and operation (See Lynch, ¶ [0004 and 0005]).
However, Karade and Lynch fail to teach determining, based on the osteotomy point, total surface area of overhang and underhang.
Lang, working in the same field of endeavor, teaches: determining, based on the osteotomy point, total surface area of overhang and underhang (See Lang, ¶ [0732], For example, in a knee replacement, hip replacement or shoulder replacement procedure, a bone cut can be applied, optionally using virtual guidance of a bone saw by the OHMD, to a distal femur, proximal tibia, proximal femur or proximal humerus. The position, alignment and/or orientation of the bone cut, including, optionally, the surface/surface area, perimeter, perimeter shape, and/or shape of the cut surface can then be assessed in the live patient).
Thus, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Karade’s and Lynch’s reference determining, based on the osteotomy point, total surface area of overhang and underhang based on the method of Lang’s reference. The suggestion/motivation would have been to improve surgical planning and operation (See Lang, ¶ [0004 and 0005]).
Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Lang with Karade and Lynch to obtain the invention as specified in claim 17.
Regarding claim 18, Karade in view of Lynch further in view of Lang teaches the process of claim 17, wherein determining an optimal osteotomy angle (See Karade, ¶ [0224], For tibia, reference axis 1 will be calculated in the AP plane at an angle MPTA (ideal) with the joint line measured from medial side passing through proximal joint centre and reference axis 2 will be calculated in the AP plane at an angle LDTA (ideal) with the joint line measured from lateral side passing through distal joint centre. Note: Examiner interpreting the angle LDTA (IDEAL) as the osteotomy angle) comprises: [determining, based on the osteotomy point, total surface area of overhang and underhang resulting from rotation of the distal portion of the tibia relative to the proximal portion of the tibia for an osteotomy performed at a second osteotomy angle across the optimal osteotomy point].
However, Karade fails to teach determining, based on the osteotomy point, total surface area of overhang and underhang resulting from rotation of the distal portion of the tibia relative to the proximal portion of the tibia for an osteotomy performed at a second osteotomy angle across the optimal osteotomy point.
Lynch, working in the same field of endeavor, teaches: resulting from rotation of the distal portion of the tibia relative to the proximal portion of the tibia for an osteotomy performed at a second osteotomy angle across the optimal osteotomy point (See Lynch, ¶ [0072], In specific embodiments, the bone segments can be rotated while bisected. While the bone is bisected into two separate solid bodies, the proximal and distal end can be coronally rotated to more accurately model a certain bone deformity. ¶ [0080], In specific embodiments the system can be used to generate patient specific and/or anatomic specific implants, cut guides, or other surgical implements using the nonconforming bone model (e.g., a nonconforming bone surface used to produce an anatomic patient specific surgical implement). See also [FIG. 21]).
Thus, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Karade’s reference resulting from rotation of the distal portion of the tibia relative to the proximal portion of the tibia for an osteotomy performed at a second osteotomy angle across the optimal osteotomy point based on the method of Lynch’s reference. The suggestion/motivation would have been to improve surgical planning and operation (See Lynch, ¶ [0004 and 0005]).
However, Karade and Lynch fail to teach determining, based on the osteotomy point, total surface area of overhang and underhang.
Lang, working in the same field of endeavor, teaches: determining, based on the osteotomy point, total surface area of overhang and underhang (See Lang, ¶ [0732], For example, in a knee replacement, hip replacement or shoulder replacement procedure, a bone cut can be applied, optionally using virtual guidance of a bone saw by the OHMD, to a distal femur, proximal tibia, proximal femur or proximal humerus. The position, alignment and/or orientation of the bone cut, including, optionally, the surface/surface area, perimeter, perimeter shape, and/or shape of the cut surface can then be assessed in the live patient).
Thus, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Karade’s and Lynch’s reference determining, based on the osteotomy point, total surface area of overhang and underhang based on the method of Lang’s reference. The suggestion/motivation would have been to improve surgical planning and operation (See Lang, ¶ [0004 and 0005]).
Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Lang with Karade and Lynch to obtain the invention as specified in claim 18.
Regarding claim 19, Karade in view of Lynch further in view of Lang teaches the process of claim 19, wherein determining the optimal osteotomy angle (See Karade, ¶ [0224], For tibia, reference axis 1 will be calculated in the AP plane at an angle MPTA (ideal) with the joint line measured from medial side passing through proximal joint centre and reference axis 2 will be calculated in the AP plane at an angle LDTA (ideal) with the joint line measured from lateral side passing through distal joint centre) further comprises:
[determining, based on the total surface area of overhang and underhang for osteotomies performed at the first and second osteotomy angles, an optimal osteotomy angle,
wherein the optimal osteotomy angle is the angle of the first and second osteotomy angles with the lease total surface area of overhang and underhang].
However, Karade and Lynch fail to teach determining, based on the total surface area of overhang and underhang for osteotomies performed at the first and second osteotomy angles, an optimal osteotomy angle, wherein the optimal osteotomy angle is the angle of the first and second osteotomy angles with the lease total surface area of overhang and underhang.
Lang, working in the same field of endeavor, teaches: determining, based on the total surface area of overhang and underhang for osteotomies performed at the first and second osteotomy angles, an optimal osteotomy angle (See Lang, ¶ [0732], For example, in a knee replacement, hip replacement or shoulder replacement procedure, a bone cut can be applied, optionally using virtual guidance of a bone saw by the OHMD, to a distal femur, proximal tibia, proximal femur or proximal humerus. The position, alignment and/or orientation of the bone cut, including, optionally, the surface/surface area, perimeter, perimeter shape, and/or shape of the cut surface can then be assessed in the live patient),
wherein the optimal osteotomy angle is the angle of the first and second osteotomy angles with the lease total surface area of overhang and underhang (See Lang, ¶ [0744], Options A-E, e.g. modify the last surgical step, e.g. recut the distal femoral bone, optionally with use of thicker tibial inserts to compensate for the greater bone loss or a reduced tibial cut depth, modify one of the next surgical steps, e.g. cut the tibia to account for greater or lesser femoral bone loss and/or different femoral component angulation).
Thus, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Karade’s and Lynch’s reference to determining, based on the total surface area of overhang and underhang for osteotomies performed at the first and second osteotomy angles, an optimal osteotomy angle, wherein the optimal osteotomy angle is the angle of the first and second osteotomy angles with the lease total surface area of overhang and underhang based on the method of Lang’s reference. The suggestion/motivation would have been to improve surgical planning and operation (See Lang, ¶ [0004 and 0005]).
Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Lang with Karade and Lynch to obtain the invention as specified in claim 19.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hampp et al. (US 12076090 B2) teaches the segmentation circuit 206 is further configured to generate a virtual bone model (i.e., a three-dimensional model) based on the segmented CT images. In the embodiments shown, the segmentation circuit 206 generates a virtual bone model of the femur 106 and the tibia 108. The segmentation circuit 206 may use the bone boundaries in each CT image slice defined during segmentation, stack the image slices to organize the boundaries in order and separated at known distances, and generate a surface that conforms to the boundaries. The segmentation circuit 206 may thereby generate a virtual bone model defined as a three-dimensional surface, a collection of voxels, or some other representation in a given coordinate system.
Buisseret et al. (US 9607373 B2) teaches a method includes accessing image data representing tissue and identifying one or more features of the tissue indicated by the image data. A model is selected for the tissue based on the one or more identified features. The image data is segmented and, using the model, one or more anatomical landmarks of the tissue indicated by the segmented image data are identified.
Plessers et al. (US 20220054197 A1) teaches receiving patient input data showing patient anatomy (See Plessers, ¶ [0055], (1) acquiring medical image(s) of a patient with a glenoid bone defect or arthroplasty); segmenting the patient input data; generating a three-dimensional model of the patient anatomy (See Plessers, ¶ [0055], segmenting the scapula to obtain a virtual three-dimensional surface model); collecting one or more measurements from the three-dimensional model of the patient anatomy (See Plessers, ¶ [0068], In one embodiment, in order to compare anatomy shapes (e.g., between predicted and actual shapes), distances can be measured between topologically equivalent points on models of each shape); and determining if a deformity is present in the patient anatomy (See Plessers, ¶ [0087], In some examples, multiple classification systems may be combined, such as the Wallace classification in the axial view and the Antuna classification in the frontal view (as above), which beneficially provides a user (e.g., a surgeon) a three-dimensional classification of the defect compared to the conventional two-dimensional classifications).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DION J SATCHER whose telephone number is (703)756-5849. The examiner can normally be reached Monday - Thursday 5:30 am - 2:30 pm, Friday 5:30 am - 9:30 am PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Henok Shiferaw can be reached at (571) 272-4637. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DION J SATCHER/Patent Examiner, Art Unit 2676
/SHEFALI D GORADIA/Primary Patent Examiner, Art Unit 2676
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