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 .
Response to Arguments
Applicant’s arguments, filed on November 3, 2025, with respect to the objections of claims 5 and 10, and the rejection(s) of claim(s) 1-20 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further search and consideration, a new ground(s) of rejection have been made in view of applicant’s amendments as can be further seen below.
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.
Claims 1-2, 5-8, 10-11, 14, 16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0048597 A1 to Heavener et al. (hereinafter “Heavener”) in view US 2021/0177621 A1 to Wu et al. (hereinafter “Wu”), and further in view of US 2020/0138518 A1 to Lang.
Regarding claim 1, Heavener teaches a surgical system/Computer Assisted Surgery System (abstract, line 1), the surgical system comprising:
a display (fig. 7, 220), and a processor/controller (para 0037: “Referring to FIG. 7, CAS system 200 is represented. CAS system 200 includes a controller 202 which is coupled to a haptic device arm 204 and controls the operation of the haptic device arm 204.”) configured to
receive positional information comprising a plurality of acquired data points associated with a surface of an anatomical feature of a patient (para 0029 and fig. 2, 30), determining a point cloud based on a plurality of data points (para 0030), and determining a boundary (or boundaries) associated with the point cloud (see para 0030 and 0042: “The best fit placement may be the registration of two point clouds, one corresponding to the anatomical structure contour and one corresponding to a top surface contour of the implant.”). The boundary associated with the point cloud (or point clouds) would be the anatomical structure contour and/or the top surface contour of the implant as stated above. However, Heavener but does not disclose wherein the processor/controller of the surgical system is configured to extract/select a point from the plurality of data points as indicating a landmark on the anatomical feature,
compare a distance between the boundary and the landmark point to a predetermined threshold, wherein:
if the distance between the boundary and the landmark point is within the predetermined threshold, the controller is further configured to:
store the landmark point
and
if the distance between the boundary and the landmark point is not within the predetermined threshold, the controller is further configured to:
generate an indication requiring confirmation of the landmark point or a suggestion to acquire additional data points.
However, Wu teaches a registration system for an orthopedic joint replacement surgery and method for intra-operative pelvic registration (see para 0002). The system (figs. 3A, 4, and 12D) teaches wherein the processor/controller and computer system of the surgical system is configured to extract/select a point from the plurality of data points as indicating a landmark on the anatomical feature (see para 0200, para 0202, para 0211— emphasis on the following sentence: “Additionally or alternatively, the system 5 may include a quality metric by instructing the user to collect additional points on the patient's anatomy at different locations, and then the system 5 measures the distance between the captured point and the corresponding surface of the three dimensional bone model 512 to ensure registration accuracy is acceptable.”, para 0287-0288, and para 0290),
determine a boundary (a patient’s bone) associated with the point cloud (see para 0030: “Aspects of the present disclosure may involve a computer-implemented method of registration that may include receiving first data points in a point-cloud corresponding to points on a patient bone in a first location that are registered with a navigated instrument.”),
compare a distance between the boundary/bone surface and the landmark point/point to a predetermined threshold (a certain threshold—see para 0211-0212),
wherein:
if the distance between the boundary and the landmark point is within the predetermined threshold (exceeding a threshold), the controller is further configured to:
store the landmark point (see para 0200, para 0202, and para 0211-0212). The landmark point(s) are ultimately always stored whether the comparison to the threshold results in a low confidence of registration or high/higher confidence of registration. This allows for refining of the registration transform). However, Wu does not explicitly disclose wherein, if the distance between the boundary and the landmark point is not within the predetermined threshold, the controller is further configured to:
generate an indication requiring confirmation of the landmark point or a suggestion to acquire additional data points.
However, Lang teaches systems/devices and methods for optical guidance for surgical procedures using an optical head mounted display (OHMD) (title and abstract). The system (fig. 5, 7, and fig. 8A-8H) compares the boundary/perimeter and/or surface area of a physical cut distal femoral bone (comparable to a landmark point) and the boundary/perimeter and/or surface area of a virtually planned cut distal femoral bone (comparable to the boundary) to determine if the difference between the location of the physical and virtual cut exceeds a predetermined threshold value (such as 2 mm or greater cut depth), and if the threshold value is not within the predetermined threshold (exceeding the threshold), then the system allows the surgeon to modify the virtual cut plane after a binary yes/no system triggers an alert (wherein the binary yes/no alert is comparable to generating the indication needed to confirm the landmark point) (para 0073, para 0484, and para 0754).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Heavener with the teachings of Wu and Lang to arrive at the claimed invention. Such modifications would improve the system by ensuring that the selected landmark point and the boundary are within the appropriate distance range to ensure the surgical instrument makes precise/accurate contact with the target anatomical structure, ultimately ensuring the imageless surgical procedure is conducted in a safe and effective manner.
Regarding claim 2, Heavener as modified teaches the surgical system of claim 1, wherein the boundary/contour is a border defined by edges of the point cloud (such as the anatomical structure contour-para 0042).
Regarding claim 5, Heavener as modified teaches the surgical system of claim 1, wherein the boundary/contour is a plane defined by the point cloud (para 0042). The boundary/contour of the anatomical structure and the top surface of the implant correspond to a “plane” defined by the point cloud.
Regarding claim 6, Heavener as modified teaches the surgical system of claim 5, but does not disclose wherein, the distance between the plane and the landmark point is not within the predetermined threshold if the distance is greater than the threshold.
However, Lang teaches systems/devices and methods for optical guidance for surgical procedures using an optical head mounted display (OHMD) (title and abstract). The system (fig. 5, 7, and fig. 8A-8H) compares the boundary/perimeter and/or surface area of a physical cut distal femoral bone (comparable to a landmark point) and the boundary/perimeter and/or surface area of a virtually planned cut distal femoral bone (comparable to the boundary) to determine if the difference between the location of the physical and virtual cut exceeds a predetermined threshold value (such as 2 mm or greater cut depth), and if the threshold value is not within the predetermined threshold (exceeding the threshold), then the system allows the surgeon to modify the virtual cut plane after a binary yest/no system triggers an alert (para 0073, para 0484, and para 0754).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Heavener with the teachings of Lang to arrive at the claimed invention. Such modifications would improve the system, since using a distance that exceeds the threshold will show that the instrument is not within proper alignment to perform the surgical procedure safely on the target region, ultimately ensuring the surgical procedure is conducted in a safe and effective manner.
Regarding claim 7, Heavener as modified teaches the surgical system of claim 6, but does not disclose wherein, if the distance between the plane and the landmark point is not within the predetermined threshold, the processor/controller is further configured to extract a second point from the plurality of data points as indicating the landmark on the anatomical feature.
However, Lang teaches wherein if the distance between the plane (virtual plane) and the landmark point (new substituted virtual femur cut) is not within a predetermined threshold, the processor/controller is further configured to extract a second point (which can include modifying the last surgical step or modifying the registration of information of the virtual data in relationship of live patient data) from the plurality of data points (wherein the plurality of data point is the plurality of virtual and patient data of the surgical plan) (figs. 7A-7H, figs. 8A-8H, para 0740, 0744, para 0751, and para 0754).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Heavener with the teachings of Lang to arrive at the claimed invention. Such modifications would improve the system, since using a distance that falls below the threshold to select a new second landmark point will allow the end effector to properly align with the target anatomical region, ultimately ensuring the imageless surgical device targets the anatomical region safe and effective manner for the surgical procedure.
Regarding claim 8, Heavener as modified teaches the surgical system of claim 6, but does not disclose wherein, if the distance between the plane and the landmark point is not within the predetermined threshold, the processor/controller is further configured to recalculate the plane defined by the point cloud by removing the landmark point.
However, Lang teaches wherein, if the distance between the plane and the landmark point is not within the predetermined threshold, the processor is further configured to recalculate the plane defined by the point cloud by removing/modifying or altering the landmark point (altering the live patient data perimeter and/or surface area for the physical distal femoral cut)(para 0073, 0484, 0740, 0744, 0751, 0754, and para 1183).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Heavener with the teachings of Lang to arrive at the claimed invention. Such modifications would improve the system by ensuring the landmark point associated with the plane distance that does not fall within the predetermined threshold can be removed and updated with a new landmark point that will properly align with the target anatomical region, ultimately enhancing the safety and accuracy when performing of the surgical procedure.
Regarding claim 10, Heavener as modified teaches the surgical system of claim 1, but does not disclose wherein the boundary is a surface mesh defined by the point cloud.
However, Lang teaches wherein the boundary/surface area and/or surface is a surface mesh defined by the point cloud (para 1849).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Heavener with the teachings of Lang to arrive at the claimed invention. Such modifications would improve the system by providing the operator with additional information that can supplement the registration of the digitized landmarks for registration with the patient’s physical anatomy, ultimately enhancing safety and accuracy when performing of the surgical procedure.
Regarding claim 11, Heavener as modified teaches the surgical system of claim 1, wherein the processor/controller is further configured to compare a surface location of the landmark point (such as the top surface of the implant) with surface locations of the other data points in the plurality of data points (see annotated fig. 2-3 below, para 0035, and para 0042).
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Regarding claim 14, Heavener teaches the method (abstract, lines 1-3) implemented on a surgical system controller (see para 0037 and para 0044), comprising:
receiving positional information comprising a plurality of acquired data points associated with a surface of an anatomical feature of a patient (para 0029 and fig. 2, 30);
determining a point cloud based on the plurality of data points (para 0030), and determining a boundary (or boundaries) associated with the point cloud (see para 0030 and 0042: “The best fit placement may be the registration of two point clouds, one corresponding to the anatomical structure contour and one corresponding to a top surface contour of the implant.”). The boundary associated with the point cloud (or point clouds) would be the anatomical structure contour and/or the top surface contour of the implant as stated above. However, Heavener does not disclose extracting a point from the plurality of data points as indicating a landmark on the anatomical feature,
comparing a distance between the boundary and the landmark point to a predetermined threshold,
and if the distance between the boundary and the landmark point is within the predetermined threshold, storing the landmark point;
and if the distance between the boundary and the landmark point is not within the predetermined threshold, generating an indication requiring confirmation of the landmark point or a suggestion to acquire additional data points.
However, Wu teaches a registration system for an orthopedic joint replacement surgery and method for intra-operative pelvic registration (see para 0002). The system (figs. 3A, 4, and 12D) teaches wherein the processor/controller and computer system of the surgical system is configured to extract/select a point from the plurality of data points as indicating a landmark on the anatomical feature (see para 0200, para 0202, para 0211— emphasis on the following sentence: “Additionally or alternatively, the system 5 may include a quality metric by instructing the user to collect additional points on the patient's anatomy at different locations, and then the system 5 measures the distance between the captured point and the corresponding surface of the three dimensional bone model 512 to ensure registration accuracy is acceptable.”, para 0287-0288, and para 0290),
determine a boundary (a patient’s bone) associated with the point cloud (see para 0030: “Aspects of the present disclosure may involve a computer-implemented method of registration that may include receiving first data points in a point-cloud corresponding to points on a patient bone in a first location that are registered with a navigated instrument.”),
compare a distance between the boundary/bone surface and the landmark point/point to a predetermined threshold (a certain threshold—see para 0211-0212),
wherein:
if the distance between the boundary and the landmark point is within the predetermined threshold (exceeding a threshold), the controller is further configured to:
store the landmark point (see para 0200, para 0202, and para 0211-0212). The landmark point(s) are ultimately always stored whether the comparison to the threshold results in a low confidence of registration or high/higher confidence of registration. This allows for refining of the registration transform). However, Wu does not explicitly disclose wherein, if the distance between the boundary and the landmark point is not within the predetermined threshold, the controller is further configured to:
generate an indication requiring confirmation of the landmark point or a suggestion to acquire additional data points.
However, Lang teaches systems/devices and methods for optical guidance for surgical procedures using an optical head mounted display (OHMD) (title and abstract). The system (fig. 5, 7, and fig. 8A-8H) compares the boundary/perimeter and/or surface area of a physical cut distal femoral bone (comparable to a landmark point) and the boundary/perimeter and/or surface area of a virtually planned cut distal femoral bone (comparable to the boundary) to determine if the difference between the location of the physical and virtual cut exceeds a predetermined threshold value (such as 2 mm or greater cut depth), and if the threshold value is not within the predetermined threshold (exceeding the threshold), then the system allows the surgeon to modify the virtual cut plane after a binary yes/no system triggers an alert (wherein the binary yes/no alert is comparable to generating the indication needed to confirm the landmark point) (para 0073, para 0484, and para 0754).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Heavener with the teachings of Wu and Lang to arrive at the claimed invention. Such modifications would improve the system by ensuring that the selected landmark point and the boundary are within the appropriate distance range to ensure the surgical instrument makes precise/accurate contact with the target anatomical structure, ultimately ensuring the imageless surgical procedure is conducted in a safe and effective manner.
Regarding claim 16, Heavener as modified teaches the method of claim 14, wherein boundary is a plane defined by the point cloud (para 0042), but does not disclose wherein the distance between the plane and the landmark point is not within the predetermined threshold if the distance is greater than the threshold.
However, Lang teaches systems/devices and methods for optical guidance for surgical procedures using an optical head mounted display (OHMD) (title and abstract). The system (fig. 5, 7, and fig. 8A-8H) compares the boundary/perimeter and/or surface area of a physical cut distal femoral bone (comparable to a landmark point) and the boundary/perimeter and/or surface area of a virtually planned cut distal femoral bone (comparable to the boundary) to determine if the difference between the location of the physical and virtual cut exceeds a predetermined threshold value (such as 2 mm or greater cut depth), and if the threshold value is not within the predetermined threshold (exceeding the threshold), then the system allows the surgeon to modify the virtual cut plane after a binary yest/no system triggers an alert (para 0073, para 0484, and para 0754).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Heavener with the teachings of Lang to arrive at the claimed invention. Such modifications would improve the system, since using a distance that exceeds the threshold will show that the instrument is not within proper alignment to perform the surgical procedure safely on the target region, ultimately ensuring the surgical procedure is conducted in a safe and effective manner.
Regarding claim 18, Heavener as modified teaches the method of claim 14, but does not disclose wherein, if the distance between the plane and a first landmark point is not within the predetermined threshold, performing at least one of:
ignoring the first landmark point and extracting a second point from the plurality of data points as indicating the landmark on the anatomical feature;
or removing the first landmark point and recalculating the plane defined by the point cloud.
However, Lang teaches wherein, if the distance between the plane and the landmark point is not within the predetermined threshold, the processor is further configured to recalculate the plane defined by the point cloud by removing/modifying or altering the landmark point (altering the live patient data perimeter and/or surface area for the physical distal femoral cut)(para 0073, 0484, 0740, 0744, 0751, 0754, and para 1183).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Heavener with the teachings of Lang to arrive at the claimed invention. Such modifications would improve the system by ensuring the landmark point associated with the plane distance that does not fall within the predetermined threshold can be removed and updated with a new landmark point that will properly align with the target anatomical region, ultimately enhancing the safety and accuracy when performing of the surgical procedure.
Regarding claim 19, Heavener as modified teaches the method of claim 14, further comprising comparing a surface location of the landmark point (such as the top surface of the implant) with surface locations of the other data points in the plurality of data points (see annotated fig. 2-3 below, para 0035, and para 0042).
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Claims 3 and 15 is rejected under 35 U.S.C. 103 as being unpatentable over Heavener in view of Wu and Lang, and further in view of US 10,905,499 B2 to Rafii-Tarri.
Regarding claim 3, Heavener as modified teaches the surgical system of claim 2, but does not disclose wherein the distance between the border and the landmark point is not within the predetermined threshold if the distance is less than the threshold.
However, Lang teaches systems/devices and methods for optical guidance for surgical procedures using an optical head mounted display (OHMD) (title and abstract). The system (fig. 5, 7, and fig. 8A-8H) compares the boundary/perimeter and/or surface area of a physical cut distal femoral bone (comparable to a landmark point) and the boundary/perimeter and/or surface area of a virtually planned cut distal femoral bone (comparable to the boundary) to determine if the difference between the location of the physical and virtual cut exceeds a predetermined threshold value (such as 2 mm or greater cut depth), and if the threshold value is not within the predetermined threshold (exceeding the threshold), then the system allows the surgeon to modify the virtual cut plane after a binary yest/no system triggers an alert (para 0073, para 0484, and para 0754). Lang does not disclose wherein the threshold value being less than the threshold indicates that the threshold value is not within the predetermined threshold.
However, Rafii-Tarri teaches systems and methods for location sensor-based branch predictions (figs. 1 and 8). During certain surgical procedures, the target path of a target to which an instrument may be driven (landmark point) and the contralateral registration path are stored in memory, and after the system stores the paths in memory, the system will determine if the instrument is on the appropriate path to the target tissue/point using a threshold probability, and if the probability is less than the threshold probability, the system provides a visual indication to a display that the user is not on the correct target path (col. 33, lines 22-41).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Heavener with the teachings of Lang and Rafii-Tari to arrive at the claimed invention. Such modifications would improve the system, since using a distance that falls below the threshold will shows that the instrument is not properly aligned to perform the surgical procedure safely on the target region, ultimately ensuring the surgical procedure is conducted in a safe and effective manner.
Regarding claim 15, Heavener as modified teaches the method of claim 14, wherein the boundary is a border defined by edges of the point cloud (such as the anatomical structure contour-para 0042), but does not disclose wherein
If the distance between the border and the landmark point is not within the predetermined threshold if the distance is less than the threshold.
However, Lang teaches systems/devices and methods for optical guidance for surgical procedures using an optical head mounted display (OHMD) (title and abstract). The system (fig. 5, 7, and fig. 8A-8H) compares the boundary/perimeter and/or surface area of a physical cut distal femoral bone (comparable to a landmark point) and the boundary/perimeter and/or surface area of a virtually planned cut distal femoral bone (comparable to the boundary) to determine if the difference between the location of the physical and virtual cut exceeds a predetermined threshold value (such as 2 mm or greater cut depth), and if the threshold value is not within the predetermined threshold (exceeding the threshold), then the system allows the surgeon to modify the virtual cut plane after a binary yest/no system triggers an alert (para 0073, para 0484, and para 0754). Lang does not disclose wherein the threshold value being less than the threshold indicates that the threshold value is not within the predetermined threshold.
However, Rafii-Tarri teaches systems and methods for location sensor-based branch predictions. The system (figs. 1 and 8) explain that during certain surgical procedures, the target path of a target to which an instrument may be driven (landmark point) and the contralateral registration path are stored in memory, and after the system stores the paths in memory, the system will determine if the instrument is on the appropriate path to target the target tissue/point using a threshold probability, and if the threshold probability is less than the threshold probability, the system provides a visual indication to a display the user is not on the correct target path (col. 33, lines 22-41).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Heavener with the teachings of Lang and Rafii-Tari to arrive at the claimed invention. Such modifications would improve the system, since using a distance that falls below the threshold will show that the instrument is not within proper alignment to perform the surgical procedure safely on the target region, ultimately ensuring the surgical procedure is conducted in a safe and effective manner.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Heavener in view of Wu, Lang, and Rafii-Tarri, and further in view of US 10,861,175 B1 to Monaghan et al. (hereinafter “Monaghan”).
Regarding claim 4, Heavener as modified teaches the surgical system of claim 3, wherein the controller is configured to receive positional information comprising an acquired subsequent data point (para 0029 and fig. 2, 30), but does not disclose wherein the processor is further configured to:
determine an updated/modified point cloud based on the plurality of data points and the subsequent data point;
and determine an updated border/periphery associated with the updated point cloud.
However, Monaghan teaches a comparator that automatically detects and quantifies microscopic variance to a feature in a 3D object based on point cloud imaging of a 3D object (abstract, lines 1-4). The system (fig. 6 ) contains a processor (fig. 10, 1020 and col. 15, lines 39-49) configured to determine an updated/modified point cloud based on the plurality of data points and the subsequent data point(s) (data points associated with both the first point cloud and second point cloud),
and determine an updated border/periphery associated with the updated point cloud (updating the periphery of the second point cloud in this case) (col. 19-claim 7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Heavener with the teachings of Monaghan to arrive at the claimed invention. Such modification would improve the system by ensuring the landmark point and boundary distance are updated properly if the initial landmark point and boundary distance is not within the predetermined threshold to safely target the anatomical region, ultimately enhancing the safety and accuracy when performing of the surgical procedure.
Claims 9, 13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Heavener in view of Wu, and Lang, and further in view of Monaghan.
Regarding claim 9, Heavener as modified teaches the surgical system of claim 6, wherein the processor/controller is further configured to:
receive positional information comprising an acquired subsequent data point (para 0029 and fig. 2, 30), but does not disclose determining an updated point cloud based on the plurality of data points and the subsequent data point;
and determine an updated plane associated with the updated point cloud.
However, Monaghan teaches determining an updated point cloud (updating the second point cloud) based on the plurality of data points (first point cloud data points) and the subsequent data point (data point(s) from the second point cloud) (col. 19, claim 7), and determining an updated plane/periphery associated with the updated point cloud (col. 3, lines 30-49 and col. 19, claim 7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Heavener with the teachings of Monaghan to arrive at the claimed invention. Such modification would improve the system by ensuring the updated point cloud and plane are in proper alignment with the target anatomical region, ultimately enhancing the effectiveness and accuracy of locating the target anatomical region when performing of the surgical procedure.
Regarding claim 13, Heavener as modified teaches the surgical system of claim 1, but does not disclose wherein the processor is further configured to compare a collection order associated with acquisition of the plurality of data points.
However, Monaghan teaches wherein the processor is further configured to compare a collection order (comparing the collection order of the internal and external landmarks to identify the particular features) associated with acquisition of the plurality of data points (point cloud data points)(col. 7, lines 33-67 and col. 8, lines 1-9).
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Heavener with the teachings of Monaghan to arrive at the claimed invention. Such modification would improve the system by allowing a distance trend to be detected between different landmark point and a plurality of data points, ultimately determining which points within the plurality of points accurately depict the target anatomical region and which points are inaccurate.
Regarding claim 17, Heavener as modified teaches the method of claim 14, further comprising:
receiving positional information comprising an acquired subsequent data point (para 0029 and fig. 2, 30), but does not disclose
determining an updated point cloud based on the plurality of data points and the subsequent data point;
and determining an updated boundary associated with the updated point cloud.
However, Monaghan teaches determining an updated point cloud (updating the second point cloud) based on the plurality of data points (first point cloud data points) and the subsequent data point (data point(s) from the second point cloud) (col. 19, claim 7), and determining an updated plane/periphery or boundary associated with the updated point cloud (col. 3, lines 30-49 and col. 19, claim 7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Heavener with the Monaghan to arrive at the claimed invention. Such modification would improve the system by ensuring the updated point cloud and boundary/periphery are in proper alignment with the target anatomical region, ultimately enhancing the effectiveness and accuracy of locating the target anatomical region when performing of the surgical procedure.
Claims 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Heavener in view of Wu, Lang, and Monaghan, and further in view of US 10,105,149 B2 to Haider et al. (hereinafter “Haider”).
Regarding claim 12, Heavener as modified teaches the surgical system of claim 11, but does not disclose wherein the processor/controller is further configured to:
determine respective distances between the landmark point and each of the data points in the plurality of data points, wherein if the distance between the landmark point and each of the data points is not within a second predetermined threshold, the processor is further configured to:
generate an indication requiring confirmation of the landmark point or a suggestion to acquire additional data points;
or remove the landmark point.
However, Monaghan teaches wherein a processor (col. 15, lines 39-49) is configured to determine respective distances between the landmark point and each of the data points in the plurality of data points (col. 9, lines 32-62), but does not disclose using more than one threshold/ a second threshold.
However, Haider teaches a system (fig. 1) containing a processor (col. 15, lines 6-12) that selects/extracts an anatomical landmark surrounded by a plurality of acquired points using the navigation system and the Computer aided surgery (CAS) system (col. 51, lines 43-58). Furthermore, in another embodiment of the invention, the CAS system compares the distance between a boundary (a bone reference frame) to a pointer (landmark point), and compares this distance to one or more predetermined threshold(s) (col. 50, lines 24-46, col. 51, lines 43-58, and col. 92, lines 7-28), but does not disclose wherein if the distance between the landmark point and each of the data points is not within a second predetermined threshold, the processor is further configured to:
generate an indication requiring confirmation of the landmark point or a suggestion to acquire additional data points, or remove the landmark point.
However, Lang teaches wherein the system (fig. 5, 7, and fig. 8A-8H) compares the boundary/perimeter and/or surface area of a physical cut distal femoral bone (comparable to a landmark point) and the boundary/perimeter and/or surface area of a virtually planned cut distal femoral bone (comparable to the boundary) to determine if the difference between the location of the physical and virtual cut exceeds a predetermined threshold value (such as 2 mm or greater cut depth), and if the threshold value is not within the predetermined threshold (exceeding the threshold), then the system allows the surgeon to modify the virtual cut plane after a binary yes/no system triggers an alert (wherein the binary yes/no alert is comparable to generating the indication needed to confirm the landmark point) (para 0073, para 0484, and para 0754).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Heavener with the teachings of Haider and Lang to arrive at the claimed invention. Such modifications would improve the system by ensuring that the selected landmark point and the boundary are within the appropriate distance range to ensure the surgical instrument makes precise/accurate contact with the target anatomical structure, ultimately ensuring the imageless surgical procedure is conducted in a safe and effective manner.
Regarding claim 20, Heavener as modified teaches the method of claim 14, but does not disclose wherein, further comprising determining respective distances between the landmark point and each of the data points in the plurality of data points;
and if the distance between the landmark point and each of the data points is not within a second predetermined threshold, performing at least one of:
generating an indication requiring confirmation of the landmark point; generating an indication suggesting a user acquire additional data points;
or removing the landmark point.
However, Monaghan teaches wherein a processor (col. 15, lines 39-49) is configured to determine respective distances between the landmark point and each of the data points in the plurality of data points (col. 9, lines 32-62), but does not disclose using more than one threshold/ a second threshold.
However, Haider teaches a system (fig. 1) containing a processor (col. 15, lines 6-12) that selects/extracts an anatomical landmark surrounded by a plurality of acquired points using the navigation system and the Computer aided surgery (CAS) system (col. 51, lines 43-58). Furthermore, in another embodiment of the invention, the CAS system compares the distance between a boundary (a bone reference frame) to a pointer (landmark point), and compares this distance to one or more predetermined thresholds) compares a distance between the boundary (bone reference frame) and the landmark point to a predetermined threshold (col. 50, lines 24-46, col. 51, lines 43-58, and col. 92, lines 7-28), but does not disclose wherein if the distance between the landmark point and each of the data points is not within a second predetermined threshold, the processor is further configured to:
generate an indication requiring confirmation of the landmark point or a suggestion to acquire additional data points, or remove the landmark point.
However, Lang teaches wherein the system (fig. 5, 7, and fig. 8A-8H) compares the boundary/perimeter and/or surface area of a physical cut distal femoral bone (comparable to a landmark point) and the boundary/perimeter and/or surface area of a virtually planned cut distal femoral bone (comparable to the boundary) to determine if the difference between the location of the physical and virtual cut exceeds a predetermined threshold value (such as 2 mm or greater cut depth), and if the threshold value is not within the predetermined threshold (exceeding the threshold), then the system allows the surgeon to modify the virtual cut plane after a binary yes/no system triggers an alert (wherein the binary yes/no alert is comparable to generating the indication needed to confirm the landmark point) (para 0073, para 0484, and para 0754).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Heavener with the teachings of Haider and Lang to arrive at the claimed invention. Such modifications would improve the system by ensuring that the selected landmark point and the boundary are within the appropriate distance range to ensure the surgical instrument makes precise/accurate contact with the target anatomical structure, ultimately ensuring the imageless surgical procedure is conducted in a safe and effective manner.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2021/0299877 A1 to Demanget et al. teaches a robotic surgical system designed to accept input spatial data from a spatial-data acquisition device and output a set of indications for positioning the robotic device at a specific anatomical target.
US 2021/0113270 A1 to Lavallee et al. teaches a method for guiding position and orientation of a robotic device containing a surgical tool configured for operating of a planned region of an anatomical structure.
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792