DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05 June 2026 has been entered.
Response to Amendment
3. According to the Amendment, filed 05 June 2026, the status of the claims is as follows:
Claims 1, 5, 10, 11, and 14 are currently amended;
Claims 6 and 9 are previously presented; and
Claims 2-4, 7, 8, and 12, 13, and 15-20 are as originally filed.
Response to Arguments
4. Applicant’s arguments, see Remarks, pp. 6-8, filed 05 June 2026, with respect to the rejection of claims 1-7, 9-17, 19, and 20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Revie et al., WO Patent No. 2006/129087 A1 (“Revie”), have been fully considered, and are persuasive in view of the Amendment, filed 05 June 2026. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection, which was necessitated by amendment, is discussed below.
Claim Rejections - 35 USC § 102
5. 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.
6. The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
7. Claims 1-7, 9-17, 19, and 20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Van Vorhis et al., U.S. Patent Application Publication No. 2009/0209884 A1 (“Van Vorhis”).
As to Claim 1, Van Vorhis teaches the following:
A surgical system (“surgical computer system”) 210 (see “The invention relates to surgical computer systems, including computer program products, and methods for implant planning using corrected captured joint motion information.” in para. [0002], and see fig. 14), comprising:
a tracking system (“tracking (or localizing) system”) 240 configured to intraoperatively track positions of bones a first bone (“femur”) F of a joint relative to a second bone (“tibia”) T of the joint (see “The system 210 also includes a tracking (or localizing) system 240 that is configured to determine a pose (i.e., position and/or orientation) of one or more objects to detect movement of the object(s). The tracking system 240 can be used, for example, to track movement of anatomy and/or surgical tools during a surgical procedure and/or to track the pose of the femur F and the tibia T as the joint 120 is moved through a range of motion. … As a result, the computing system 220 can capture data in response to movement of the tracked object or objects. Tracked objects may include, for example, tools/instruments, patient anatomy, implants/prosthetic devices, and components of the surgical system 210. Using pose data from the tracking system 240, the surgical system 210 is also able to register (or map or associate) coordinates in one space to those in another to achieve spatial alignment or correspondence (e.g., using a coordinate transformation process as is well known). … Based on tracked object and registration data, the surgical system 210 may determine, for example, a spatial relationship between the image of the anatomy and the relevant anatomy (i.e., between the image space and the physical space).” in para. [0089]);
a user interface (“input device”) 225 configured to obtain a user input (see “The input device 225 of the computing system 220 enables the user to communicate with the surgical system 210. The input device 225 is connected to the computer 221 and may include any device enabling a user to provide input to a computer. For example, the input device 225 can be a known input device, such as a keyboard, a mouse, a trackball, a touch screen, a touch pad, voice recognition hardware, dials, switches, buttons, a trackable probe, a foot pedal, a remote control device, a scanner, a camera, a microphone, and/or a joystick.” in para. [0087]) indicating a post-operative value (“selected flexion angle”) for the joint (see “FIG. 5 shows an example computer display of a gap analysis of the positions of the implant models 20, 30. In some embodiments, the computer display includes a user input 50 for inputting a selected flexion angle .theta. for a pose and an indicator 51 that shows a value of the gap 31 at the selected flexion angle .theta.. In the example of FIG. 5, at a pose with a flexion angle .theta. of 0 degrees, there is a gap 31 of 1.2 mm between the femoral implant model 20 and the tibial implant model 30. Likewise, when the lowest signed distance between the surfaces of the implant models 20, 30 is a negative value, an overlap is detected between the implant models 20, 30.” in para. [0072]; and see “In some embodiments, the computer display includes a user input 90 for inputting a selected flexion angle .theta. and an indicator 91 that shows a value of the overlap 70 at the selected flexion angle .theta.. In the example of FIG. 9, at a pose with a flexion angle .theta. of 90 degrees, there is an overlap of 0.3 mm between the femoral implant model 20 and the tibial implant model 30. Based on the information provided by the virtual analysis shown in FIGS. 5 and 9, when a surgeon is planning the placement of actual implants corresponding to the implant models 20, 30, he can adjust the implant models 20, 30 to achieve the desired relationship between the implant models 20, 30 at any selected pose (e.g., angle .theta.) within the range of motion of the joint. For example, the surgeon may adjust the implant models 20, 30 to ensure that the gap 31 is filled at the pose with a flexion angle .theta. of 0 degrees and the overlap 70 is removed at the pose with a flexion angle .theta. of 90 degrees by repositioning the implant models 20, 30 until the surfaces of the implant models 20, 30 just "touch" each other at selected pose angles within the range of motion of the joint 120.” in para. [0075]); and
a computer (“computer”) 221 programmed to (see “The computer 221 may be any known computing system but is preferably a programmable, processor-based system.” in para. [0084]):
generate, based on (i) the positions of the first bone of the joint relative to the second bone of the joint (see “The computing system 220 can optionally be programmed to determine (520) whether any additional bone pose data is needed for the range of motion. This can be automated, for example, by having a set of predetermined joint flexion angles at which data is collected. If data has not been taken at each of the predetermined flexion angles, the computing system 220 determines (520) that additional bone pose data is needed and displays or otherwise communicates to the operator the next limb pose (e.g., flexion angle .theta.) to which the joint should be positioned. Upon indication by the operator that the joint is at the indicated pose, the computing system 220 communicates with the tracking system 240 to retrieve the bone pose data and repeats steps 510 and 515. In addition or as an alternative to the set of predetermined poses, the computing system 220 can, through an interface (e.g., displayed text, voice synthesis, etc.), ask the operator whether there are any additional poses (or angles) at which data should be taken. Typically, there are at least two angles (or poses) at which data is captured to calculate the relative poses of the bones through a range of motion of the joint. In a preferred embodiment, data is taken at 10, 40, 60, and 90 degrees of flexion.” in para. [0097]), a value for a planned orientation (“captured pose indicator (722A, 722B, 722C, collectively 722)”) 722 for an implant to be implanted in the joint (see “The captured pose indicator can indicate, for example, one or more pose angles at which joint motion data can be captured. Pose data can be captured discretely with the limb in one or more particular poses and/or continuously as the joint moves through a range of motion. For example, in some embodiments, bone pose data for a first pose can be captured discretely with the leg at a first angle of flexion (e.g., full extension), bone pose data for a second pose can be captured discretely with the leg at a second angle of flexion (e.g., full flexion), and/or bone pose data for a range of poses can be captured continuously as the leg is moved from the first angle of flexion to the second angle of flexion. For a knee joint, the captured pose indicators 722 can accommodate the particular patient's F/E ROM. The captured pose indicators 722 can be color coded to facilitate identification of captured poses. For example, the captured pose indicators 722 can be allocated an initial color (e.g., red), and as bone pose data for the indicated poses are captured for the particular joint (e.g., the joint 120), the corresponding pose indicator can be changed to a second color (e.g., green). The resulting captured bone pose data enables the surgeon to see, for each flexion angle .theta. at which corrected pose data has been captured, the appropriate relative positions of the femur F and the tibia T when they are oriented in the appropriate alignment with appropriate ligament tension.” in para. [0100]); and
generate a surgical plan based on the value for the planned orientation for the implant (see “Based on the captured corrected pose data, the surgeon can then use virtual images of the bones and implant models (e.g., as described herein) to plan the placement of the implants in the joint 120 so that, at the various flexion angles, the appropriate relative bone positions with appropriate ligament tension are achieved when the actual implants are implanted in the joint 120.” in para. [0100]).
As to Claim 2, Van Vorhis teaches the following:
a robot (“haptic device”) 230, wherein the computer 221 is further programmed to control the robot 230 based on the surgical plan to execute a bone resection adapted to prepare one of the bones of the joint to receive the implant in the planned orientation (see “The surgical system 210 also provides haptic guidance to a user (e.g., a surgeon) and/or limits the user's manipulation of the haptic device 230 as the user performs a surgical procedure.” in para. [0082]; and see “Implementation of the surgical plan (e.g., bone cuts or resections) can be performed using a tactile guided robotic arm as described in U.S. patent application Ser. No. 11/357,197, filed Feb. 21, 2006, published as Pub. No. 2006/0142657 on Jun. 29, 2006, and hereby incorporated by reference herein in its entirety. In a preferred embodiment, the tactile guided robotic arm is the TACTILE GUIDANCE SYSTEM.TM. or the RIO.TM., manufactured by MAKO Surgical Corp., Fort Lauderdale, Fla.” in para. [0129]).
As to Claim 3, Van Vorhis teaches the following:
wherein the post-operative value is a desired separation distance between the implant and an additional implant to be implanted in the joint (see “As shown in FIGS. 21(a) and 21(b), the interactions of the representations of the first and second implant components can be influenced by limb pose. For example, as discussed above in connection with the graph 950 of FIG. 21(a), the implant components can be separated by a gap (i.e., a loose joint) at one flexion angle .theta. and overlapping (i.e., a tight joint) at another flexion angle .theta. (e.g., bar 956A indicates pose 954A has gapped implants at flexion angle .theta.=0.degree., while bar 956D indicates pose 954D has overlapping implants at flexion angle .theta.=90.degree.). One goal of implant planning is to eliminate the possibility of such variation by ensuring that a correct relationship is maintained between the implants at each of the various poses (e.g., flexion angles). A correct relationship may be maintained, for example, by preserving a proper distance between the implant components throughout the range of motion of the joint.” in para. [0119]).
As to Claim 4, Van Vorhis teaches the following:
wherein the user input indicates a range for the post-operative value (see “In some embodiments, the computer display includes a user input 90 for inputting a selected flexion angle .theta. and an indicator 91 that shows a value of the overlap 70 at the selected flexion angle .theta.. In the example of FIG. 9, at a pose with a flexion angle .theta. of 90 degrees, there is an overlap of 0.3 mm between the femoral implant model 20 and the tibial implant model 30. Based on the information provided by the virtual analysis shown in FIGS. 5 and 9, when a surgeon is planning the placement of actual implants corresponding to the implant models 20, 30, he can adjust the implant models 20, 30 to achieve the desired relationship between the implant models 20, 30 at any selected pose (e.g., angle .theta.) within the range of motion of the joint. For example, the surgeon may adjust the implant models 20, 30 to ensure that the gap 31 is filled at the pose with a flexion angle .theta. of 0 degrees and the overlap 70 is removed at the pose with a flexion angle .theta. of 90 degrees by repositioning the implant models 20, 30 until the surfaces of the implant models 20, 30 just "touch" each other at selected pose angles within the range of motion of the joint 120.” in para. [0075]).
As to Claim 5, Van Vorhis teaches the following:
wherein the computer 221 is programmed to generate the value (“bone pose data”) of the planned orientation by executing an auto-planning algorithm that uses (i) the positions of the first bone relative to the second bone of the joint and (ii) the post-operative value (“captured pose indicator”) as inputs (see “The captured pose indicator can indicate, for example, one or more pose angles at which joint motion data can be captured. Pose data can be captured discretely with the limb in one or more particular poses and/or continuously as the joint moves through a range of motion. For example, in some embodiments, bone pose data for a first pose can be captured discretely with the leg at a first angle of flexion (e.g., full extension), bone pose data for a second pose can be captured discretely with the leg at a second angle of flexion (e.g., full flexion), and/or bone pose data for a range of poses can be captured continuously as the leg is moved from the first angle of flexion to the second angle of flexion. For a knee joint, the captured pose indicators 722 can accommodate the particular patient's F/E ROM. The captured pose indicators 722 can be color coded to facilitate identification of captured poses. For example, the captured pose indicators 722 can be allocated an initial color (e.g., red), and as bone pose data for the indicated poses are captured for the particular joint (e.g., the joint 120), the corresponding pose indicator can be changed to a second color (e.g., green). The resulting captured bone pose data enables the surgeon to see, for each flexion angle .theta. at which corrected pose data has been captured, the appropriate relative positions of the femur F and the tibia T when they are oriented in the appropriate alignment with appropriate ligament tension. Based on the captured corrected pose data, the surgeon can then use virtual images of the bones and implant models (e.g., as described herein) to plan the placement of the implants in the joint 120 so that, at the various flexion angles, the appropriate relative bone positions with appropriate ligament tension are achieved when the actual implants are implanted in the joint 120.” in para. [0100]).
As to Claim 6, Van Vorhis teaches the following:
wherein the computer 221 is further programmed to generate the value for the planned orientation by executing the auto-planning algorithm for a plurality of iterations until an error based on the post-operative value is below a threshold value (see “The representations of the first and second bones are set (876) to a desired pose, such as a joint flexion angle .theta. of full extension (e.g., pose 176A of FIG. 2). The use of full extension as a starting point is illustrative only. Any other starting pose is equally applicable. The representation of the first implant component and/or the representation of the second implant component is moved (878) so that the representations of the implant components are just contacting or slightly gapped. If there are no remaining poses (e.g., flexion angles) at which the component gap should be adjusted (880), implant planning is completed (882). If there are remaining poses (e.g., joint flexion angles) which need the component gap adjusted, steps 876 through 880 are repeated for each remaining pose until completion of implant planning (882).” in para. [0120]).
As to Claim 7, Van Vorhis teaches the following:
wherein executing the auto-planning algorithm comprises handling a tradeoff between achieving the post-operative value and achieving an additional post-operative value (see “The angle selector 860 is similar to the user inputs and indicators described above in connection with FIGS. 5 and 9. The angle selector 860 slide bar can be adjusted to any angle that was captured during the bone pose data capture (See FIGS. 17-20). If limb alignment was corrected (e.g., via the corrective force 170) and the collateral ligaments were concurrently properly tensioned during the bone pose data capture along the range of motion of the joint, the representations of the bones (e.g., the femur F and the tibia T) will be correctly spaced apart, allowing for optimal implant planning. For step 878, the user can, for example, move the representation of the first implant component 804 (e.g., a representation of a femoral implant component) superiorly and/or inferiorly to contact the representation of the second implant component 806 (e.g., a representation of a tibial implant component) or to be slightly gapped. A slight gap distance can be, for example, between the range of 0 mm to 1.25 mm. In a preferred embodiment, the gap distance is about 1 mm. The gap can be estimated, for example, by calculating the closest distance from a series of points on the articular surface of the first implant component to the articular surface of the second implant component.” in para. [0121]).
As to Claim 9, Van Vorhis teaches the following:
wherein the computer 221 is programmed to generate the value for the planned orientation by determining a target location for a point on a surface of a model of the implant and rotating the model of the implant to fit the point to the target location (see “Referring to FIGS. 11-13, further analysis can be performed by selecting one or more points on the articulating surface of a first implant model (e.g., points near the center, anterior, and posterior of the surface of the tibial implant model 30), mapping these points at multiple poses of joint flexion into the space of an opposite bone (e.g., the representation 10 of the femur F) and/or a second counterpart implant model (e.g., the femoral implant model 20) using the transform relationships described previously, and displaying these mapped points in 3D or projected 2D relative to the opposite bone and/or the second implant model. Mapping may be accomplished, for example, by determining a position of each of the selected points at each of the multiple poses of joint flexion. These "mapped" points can then be used to guide the placement of the second implant model. For example, the second implant model (e.g., the femoral implant model 20) can be positioned so that the articulating surface of the second implant model has a desired relationship to the articulating surface of the first implant model (e.g., the tibial implant model 30) as represented by the mapped points. Similarly, the first implant model (e.g., the tibial implant model 30) can be positioned so that the articulating surface of the first implant model will have a desired relationship to the articulating surface of the opposite bone (e.g., the representation 10 of the femur F). Repositioning the first implant model will update the positions of the mapped points so that the relationship of the second implant model and/or the opposite bone to the first implant model can always be reestablished.” in para. [0078]).
As to Claim 10, Van Vorhis teaches the following:
wherein the computer 221 is further programmed to generate a planned position for the implant based on (i) the positions of the first bone relative to the second bone of the joint and (ii) the post-operative value (“captured pose indicator”) (see “The captured pose indicator can indicate, for example, one or more pose angles at which joint motion data can be captured. Pose data can be captured discretely with the limb in one or more particular poses and/or continuously as the joint moves through a range of motion. For example, in some embodiments, bone pose data for a first pose can be captured discretely with the leg at a first angle of flexion (e.g., full extension), bone pose data for a second pose can be captured discretely with the leg at a second angle of flexion (e.g., full flexion), and/or bone pose data for a range of poses can be captured continuously as the leg is moved from the first angle of flexion to the second angle of flexion. For a knee joint, the captured pose indicators 722 can accommodate the particular patient's F/E ROM. The captured pose indicators 722 can be color coded to facilitate identification of captured poses. For example, the captured pose indicators 722 can be allocated an initial color (e.g., red), and as bone pose data for the indicated poses are captured for the particular joint (e.g., the joint 120), the corresponding pose indicator can be changed to a second color (e.g., green). The resulting captured bone pose data enables the surgeon to see, for each flexion angle .theta. at which corrected pose data has been captured, the appropriate relative positions of the femur F and the tibia T when they are oriented in the appropriate alignment with appropriate ligament tension. Based on the captured corrected pose data, the surgeon can then use virtual images of the bones and implant models (e.g., as described herein) to plan the placement of the implants in the joint 120 so that, at the various flexion angles, the appropriate relative bone positions with appropriate ligament tension are achieved when the actual implants are implanted in the joint 120.” in para. [0100]).
As to Claim 11, Van Vorhis teaches the following:
A method executable by a surgical system (“surgical computer system”) 210 (see “The invention relates to surgical computer systems, including computer program products, and methods for implant planning using corrected captured joint motion information.” in para. [0002], and see fig. 14), the method comprising:
intraoperatively tracking relative positions of bones of a joint (see “The system 210 also includes a tracking (or localizing) system 240 that is configured to determine a pose (i.e., position and/or orientation) of one or more objects to detect movement of the object(s). The tracking system 240 can be used, for example, to track movement of anatomy and/or surgical tools during a surgical procedure and/or to track the pose of the femur F and the tibia T as the joint 120 is moved through a range of motion. … As a result, the computing system 220 can capture data in response to movement of the tracked object or objects. Tracked objects may include, for example, tools/instruments, patient anatomy, implants/prosthetic devices, and components of the surgical system 210. Using pose data from the tracking system 240, the surgical system 210 is also able to register (or map or associate) coordinates in one space to those in another to achieve spatial alignment or correspondence (e.g., using a coordinate transformation process as is well known). … Based on tracked object and registration data, the surgical system 210 may determine, for example, a spatial relationship between the image of the anatomy and the relevant anatomy (i.e., between the image space and the physical space).” in para. [0089]);
generating, based on the relative positions and a user input indicating a post-operative value for the joint (see “The computing system 220 can optionally be programmed to determine (520) whether any additional bone pose data is needed for the range of motion. This can be automated, for example, by having a set of predetermined joint flexion angles at which data is collected. If data has not been taken at each of the predetermined flexion angles, the computing system 220 determines (520) that additional bone pose data is needed and displays or otherwise communicates to the operator the next limb pose (e.g., flexion angle .theta.) to which the joint should be positioned. Upon indication by the operator that the joint is at the indicated pose, the computing system 220 communicates with the tracking system 240 to retrieve the bone pose data and repeats steps 510 and 515. In addition or as an alternative to the set of predetermined poses, the computing system 220 can, through an interface (e.g., displayed text, voice synthesis, etc.), ask the operator whether there are any additional poses (or angles) at which data should be taken. Typically, there are at least two angles (or poses) at which data is captured to calculate the relative poses of the bones through a range of motion of the joint. In a preferred embodiment, data is taken at 10, 40, 60, and 90 degrees of flexion.” in para. [0097]), a planned orientation for an implant to be implanted in the joint (see “The captured pose indicator can indicate, for example, one or more pose angles at which joint motion data can be captured. Pose data can be captured discretely with the limb in one or more particular poses and/or continuously as the joint moves through a range of motion. For example, in some embodiments, bone pose data for a first pose can be captured discretely with the leg at a first angle of flexion (e.g., full extension), bone pose data for a second pose can be captured discretely with the leg at a second angle of flexion (e.g., full flexion), and/or bone pose data for a range of poses can be captured continuously as the leg is moved from the first angle of flexion to the second angle of flexion. For a knee joint, the captured pose indicators 722 can accommodate the particular patient's F/E ROM. The captured pose indicators 722 can be color coded to facilitate identification of captured poses. For example, the captured pose indicators 722 can be allocated an initial color (e.g., red), and as bone pose data for the indicated poses are captured for the particular joint (e.g., the joint 120), the corresponding pose indicator can be changed to a second color (e.g., green). The resulting captured bone pose data enables the surgeon to see, for each flexion angle .theta. at which corrected pose data has been captured, the appropriate relative positions of the femur F and the tibia T when they are oriented in the appropriate alignment with appropriate ligament tension.” in para. [0100]),
wherein the post-operative value is a desired separation distance between the implant and an additional implant to be implanted in the joint (see “As shown in FIGS. 21(a) and 21(b), the interactions of the representations of the first and second implant components can be influenced by limb pose. For example, as discussed above in connection with the graph 950 of FIG. 21(a), the implant components can be separated by a gap (i.e., a loose joint) at one flexion angle .theta. and overlapping (i.e., a tight joint) at another flexion angle .theta. (e.g., bar 956A indicates pose 954A has gapped implants at flexion angle .theta.=0.degree., while bar 956D indicates pose 954D has overlapping implants at flexion angle .theta.=90.degree.). One goal of implant planning is to eliminate the possibility of such variation by ensuring that a correct relationship is maintained between the implants at each of the various poses (e.g., flexion angles). A correct relationship may be maintained, for example, by preserving a proper distance between the implant components throughout the range of motion of the joint.” in para. [0119]); and
guiding a bone resection based on the planned orientation for the implant (see “In operation, the surgical system 210 enables comprehensive, preoperative and/or intraoperative surgical planning. The surgical system 210 also provides haptic guidance to a user (e.g., a surgeon) and/or limits the user's manipulation of the haptic device 230 as the user performs a surgical procedure. ” in para. [0082]).
As to Claim 12, Van Vorhis teaches the following:
wherein the user input indicates a range for the post-operative value (see “In some embodiments, the computer display includes a user input 90 for inputting a selected flexion angle .theta. and an indicator 91 that shows a value of the overlap 70 at the selected flexion angle .theta.. In the example of FIG. 9, at a pose with a flexion angle .theta. of 90 degrees, there is an overlap of 0.3 mm between the femoral implant model 20 and the tibial implant model 30. Based on the information provided by the virtual analysis shown in FIGS. 5 and 9, when a surgeon is planning the placement of actual implants corresponding to the implant models 20, 30, he can adjust the implant models 20, 30 to achieve the desired relationship between the implant models 20, 30 at any selected pose (e.g., angle .theta.) within the range of motion of the joint. For example, the surgeon may adjust the implant models 20, 30 to ensure that the gap 31 is filled at the pose with a flexion angle .theta. of 0 degrees and the overlap 70 is removed at the pose with a flexion angle .theta. of 90 degrees by repositioning the implant models 20, 30 until the surfaces of the implant models 20, 30 just "touch" each other at selected pose angles within the range of motion of the joint 120.” in para. [0075]).
As to Claim 13, Van Vorhis teaches the following:
wherein guiding the bone resection based on the planned orientation for the implant comprise controlling a robot (“haptic device”) 230 to constrain movement of a cutting tool to a control object defined based on the planned orientation (see “The surgical system 210 also provides haptic guidance to a user (e.g., a surgeon) and/or limits the user's manipulation of the haptic device 230 as the user performs a surgical procedure.” in para. [0082]; and see “Implementation of the surgical plan (e.g., bone cuts or resections) can be performed using a tactile guided robotic arm as described in U.S. patent application Ser. No. 11/357,197, filed Feb. 21, 2006, published as Pub. No. 2006/0142657 on Jun. 29, 2006, and hereby incorporated by reference herein in its entirety. In a preferred embodiment, the tactile guided robotic arm is the TACTILE GUIDANCE SYSTEM.TM. or the RIO.TM., manufactured by MAKO Surgical Corp., Fort Lauderdale, Fla.” in para. [0129]).
As to Claim 14, Van Vorhis teaches the following:
wherein the post-operative value is a desired separation distance between the implant and an additional implant to be implanted in the joint (see “As shown in FIGS. 21(a) and 21(b), the interactions of the representations of the first and second implant components can be influenced by limb pose. For example, as discussed above in connection with the graph 950 of FIG. 21(a), the implant components can be separated by a gap (i.e., a loose joint) at one flexion angle .theta. and overlapping (i.e., a tight joint) at another flexion angle .theta. (e.g., bar 956A indicates pose 954A has gapped implants at flexion angle .theta.=0.degree., while bar 956D indicates pose 954D has overlapping implants at flexion angle .theta.=90.degree.). One goal of implant planning is to eliminate the possibility of such variation by ensuring that a correct relationship is maintained between the implants at each of the various poses (e.g., flexion angles). A correct relationship may be maintained, for example, by preserving a proper distance between the implant components throughout the range of motion of the joint.” in para. [0119]).
As to Claim 15, Van Vorhis teaches the following:
wherein generating the planned orientation comprises executing an auto-planning algorithm that uses the relative positions and the post-operative value (“captured pose indicator”) as inputs (see “The captured pose indicator can indicate, for example, one or more pose angles at which joint motion data can be captured. Pose data can be captured discretely with the limb in one or more particular poses and/or continuously as the joint moves through a range of motion. For example, in some embodiments, bone pose data for a first pose can be captured discretely with the leg at a first angle of flexion (e.g., full extension), bone pose data for a second pose can be captured discretely with the leg at a second angle of flexion (e.g., full flexion), and/or bone pose data for a range of poses can be captured continuously as the leg is moved from the first angle of flexion to the second angle of flexion. For a knee joint, the captured pose indicators 722 can accommodate the particular patient's F/E ROM. The captured pose indicators 722 can be color coded to facilitate identification of captured poses. For example, the captured pose indicators 722 can be allocated an initial color (e.g., red), and as bone pose data for the indicated poses are captured for the particular joint (e.g., the joint 120), the corresponding pose indicator can be changed to a second color (e.g., green). The resulting captured bone pose data enables the surgeon to see, for each flexion angle .theta. at which corrected pose data has been captured, the appropriate relative positions of the femur F and the tibia T when they are oriented in the appropriate alignment with appropriate ligament tension. Based on the captured corrected pose data, the surgeon can then use virtual images of the bones and implant models (e.g., as described herein) to plan the placement of the implants in the joint 120 so that, at the various flexion angles, the appropriate relative bone positions with appropriate ligament tension are achieved when the actual implants are implanted in the joint 120.” in para. [0100]).
As to Claim 16, Van Vorhis teaches the following:
executing the auto-planning algorithm for a plurality of iterations until an error based on the post-operative value is below a threshold value (see “The representations of the first and second bones are set (876) to a desired pose, such as a joint flexion angle .theta. of full extension (e.g., pose 176A of FIG. 2). The use of full extension as a starting point is illustrative only. Any other starting pose is equally applicable. The representation of the first implant component and/or the representation of the second implant component is moved (878) so that the representations of the implant components are just contacting or slightly gapped. If there are no remaining poses (e.g., flexion angles) at which the component gap should be adjusted (880), implant planning is completed (882). If there are remaining poses (e.g., joint flexion angles) which need the component gap adjusted, steps 876 through 880 are repeated for each remaining pose until completion of implant planning (882).” in para. [0120]).
As to Claim 17, Van Vorhis teaches the following:
wherein executing the auto-planning algorithm comprises handling a tradeoff between achieving the post-operative value and achieving an additional post-operative value (see “The angle selector 860 is similar to the user inputs and indicators described above in connection with FIGS. 5 and 9. The angle selector 860 slide bar can be adjusted to any angle that was captured during the bone pose data capture (See FIGS. 17-20). If limb alignment was corrected (e.g., via the corrective force 170) and the collateral ligaments were concurrently properly tensioned during the bone pose data capture along the range of motion of the joint, the representations of the bones (e.g., the femur F and the tibia T) will be correctly spaced apart, allowing for optimal implant planning. For step 878, the user can, for example, move the representation of the first implant component 804 (e.g., a representation of a femoral implant component) superiorly and/or inferiorly to contact the representation of the second implant component 806 (e.g., a representation of a tibial implant component) or to be slightly gapped. A slight gap distance can be, for example, between the range of 0 mm to 1.25 mm. In a preferred embodiment, the gap distance is about 1 mm. The gap can be estimated, for example, by calculating the closest distance from a series of points on the articular surface of the first implant component to the articular surface of the second implant component.” in para. [0121]).
As to Claim 19, Van Vorhis teaches the following:
wherein generating the planned orientation comprises determining a target location for a point on a surface of a model of the implant and rotating the model of the implant to fit the point to the target location (see “Referring to FIGS. 11-13, further analysis can be performed by selecting one or more points on the articulating surface of a first implant model (e.g., points near the center, anterior, and posterior of the surface of the tibial implant model 30), mapping these points at multiple poses of joint flexion into the space of an opposite bone (e.g., the representation 10 of the femur F) and/or a second counterpart implant model (e.g., the femoral implant model 20) using the transform relationships described previously, and displaying these mapped points in 3D or projected 2D relative to the opposite bone and/or the second implant model. Mapping may be accomplished, for example, by determining a position of each of the selected points at each of the multiple poses of joint flexion. These "mapped" points can then be used to guide the placement of the second implant model. For example, the second implant model (e.g., the femoral implant model 20) can be positioned so that the articulating surface of the second implant model has a desired relationship to the articulating surface of the first implant model (e.g., the tibial implant model 30) as represented by the mapped points. Similarly, the first implant model (e.g., the tibial implant model 30) can be positioned so that the articulating surface of the first implant model will have a desired relationship to the articulating surface of the opposite bone (e.g., the representation 10 of the femur F). Repositioning the first implant model will update the positions of the mapped points so that the relationship of the second implant model and/or the opposite bone to the first implant model can always be reestablished.” in para. [0078]).
As to Claim 20, Van Vorhis teaches the following:
prompting, via a graphical user interface (“the computer display includes a user input 90”) 90, a user to select the post-operative value from a plurality of options for the post-operative value (see “In some embodiments, the computer display includes a user input 90 for inputting a selected flexion angle .theta. and an indicator 91 that shows a value of the overlap 70 at the selected flexion angle .theta.. In the example of FIG. 9, at a pose with a flexion angle .theta. of 90 degrees, there is an overlap of 0.3 mm between the femoral implant model 20 and the tibial implant model 30. Based on the information provided by the virtual analysis shown in FIGS. 5 and 9, when a surgeon is planning the placement of actual implants corresponding to the implant models 20, 30, he can adjust the implant models 20, 30 to achieve the desired relationship between the implant models 20, 30 at any selected pose (e.g., angle .theta.) within the range of motion of the joint. For example, the surgeon may adjust the implant models 20, 30 to ensure that the gap 31 is filled at the pose with a flexion angle .theta. of 0 degrees and the overlap 70 is removed at the pose with a flexion angle .theta. of 90 degrees by repositioning the implant models 20, 30 until the surfaces of the implant models 20, 30 just "touch" each other at selected pose angles within the range of motion of the joint 120.” in para. [0075]).
Allowable Subject Matter
8. Claims 8 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
9. The following is a statement of reasons for the indication of allowable subject matter:
As to Claim 8, neither Van Vorhis, Revie, nor the prior art of record teaches the surgical system of base claim 7, including the following, in combination with all other limitations of the base claim:
wherein executing the auto-planning algorithm comprises minimizing a cost function comprising a sum of a first error value associated with the post-operative value and a second error value associated with the additional post-operative value.
As to Claim 18, neither Van Vorhis, Revie, nor the prior art of record teaches the method of base claim 17, including the following, in combination with all other limitations of the base claim:
wherein executing the auto-planning algorithm comprises minimizing a cost function comprising a sum of a first error value associated with the post-operative value and a second error value associated with the additional post-operative value.
Conclusion
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 06/24/2026
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