Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
No claim amendments have been provided in Applicants’ filing.
Claims 1-20 drawn to a method of planning surgery for joint replacement and system to implement the method are currently under examination.
Priority
This application filed 5/31/2022 is a continuation of 16/117898 filed 8/30/2018 (now US Patent 11,376072), which is a continuation of 13/589981 (now US Patent 10064685) filed 8/20/2012, which is a continuation of 12/333109 filed 12/21/2007 (now ABN);
and is a CIP of 11/963547 (US Patent 9101394) filed 12/21/2007, which claims benefit to provisional application 60/925269 filed 4/19/2007.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/31/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
It is noted that the IDS contain office actions related to foreign applications, but do not provide a context or specific claims or references that are discussed in the actions (see for example A122 and A123). These have been reviewed for what is provided within them, but the relevant application material such as specification, claims and cited references have not been used for the review.
Additionally, the listing of references in the specification is not a proper information disclosure statement. See for example applications listed in [0006], [0101] for example. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11376072. Although the claims at issue are not identical, they are not patentably distinct from each other because they cover substantially the same subject matter. More specifically, the method of both comprises the same steps and scope for the method of surgical planning where a model or representation of two implants is presented on a computer display and positioning of the implants can be adjusted and assessed. Elements setting forth that the soft tissue is assessed as part of the joint replacement is consistent with assessment of cartilage recited in the claims and provides for an obvious constraint that would be considered in the joint reconstruction.
Independent claim 1 from ‘072 is provided for completeness and clarity of the record:
A surgical planning computerized method, comprising:
registering a joint of a patient in physical space with a model of the joint in virtual space;
planning placement of an implant to be implanted in the joint, wherein a planned placement of the implant is determined by:
performing a soft tissue assessment of the joint; and
automatically fitting the implant relative to at least one of a bone of the joint, a second implant, a cartilage of the patient, or based on a ligament characteristic of the patient; and
generating at least one virtual boundary based on the planned placement of the implant in the joint, the at least one virtual boundary configured to control movement of a surgical tool while the tool is being used to prepare the joint to receive the implant in the planned placement.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 10064685. Although the claims at issue are not identical, they are not patentably distinct from each other because the cover substantially the same subject matter. More specifically, the method of both comprises the same steps and scope for the method of surgical planning where a model or representation of two implants is presented on a computer display and positioning of the implants can be adjusted and assessed. Elements setting forth that the soft tissue is assessed as part of the joint replacement is consistent with assessment of cartilage recited in the claims and provides for an obvious constraint that would be considered in the joint reconstruction.
Claim 1 from 10064685 is provided for comparison:
1. A surgical planning computerized method comprising:
displaying, by a display device, a representation of a bone and a representation of a first implant component with respect to the representation of the bone;
displaying, by the display device, a representation of a second implant component, wherein the first implant component and the second implant component are physically separated and not connected to each other;
generating, by a computer, a positioning constraint to which the computer automatically constrains movement of the representation of the second implant component on the display device, wherein the constraint is one of a point, an axis, a line, or a volume and wherein the positioning constraint is based on the representation of the first implant component;
allowing, by a user interface, a user to reposition the representation of the second implant component without repositioning the representation of the first implant component; and-2- 4816-8278-7410.1 Atty. Dkt. No. 051892-0628
automatically constraining, by the computer, movement of the representation of the second implant component on the display to the positioning constraint.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 9101394. Although the claims at issue are not identical, they are not patentably distinct from each other because the cover substantially the same subject matter. More specifically, the method of both comprises the same steps and scope for the method of surgical planning where a model or representation of two implants is presented on a computer display and positioning of the implants can be adjusted and assessed. Elements setting forth that the soft tissue is assessed as part of the joint replacement is consistent with assessment of cartilage recited in the claims and provides for an obvious constraint that would be considered in the joint reconstruction.
Claim 1 from US Patent 9101394 is provided for comparison:
1. A surgical planning method comprising: capturing data, using a tracking system associated with a computing system as a native joint is moved within a range of motion of a joint, the joint comprising a first bone and a second bone, wherein the computing system is further used to perform the steps of:
representing the first bone of the joint; associating a first implant model with the representation of the first bone;
representing a second bone of the joint; associating a second implant model with the representation of the second bone;
based on the captured data, determining a distance from at least one point on a surface of the first implant model to at least one point on a surface of the second implant model at a plurality of angles within the range of motion of the joint; and
displaying information representative of the respective determined distances at the plurality of angles, wherein the information representative of the respective determined distances at the plurality of angles is displayed in the form of a bar chart indicating at least one of the plurality of angles and the respective determined distance for the at least one of the plurality of angles.
For completeness of the record, it is noted that 14/822617, US Patent 9827051 and 15/465797, US Patent 9913692 are continuations of 11/963547, and they have been reviewed for possible double patenting and found to be directed to different non-obvious inventions.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Arata et al. (S 2008/0262812 A1), Lavallee et al. (US 20070219561 A1), Quaid et al. (US 2006/0142657 A1, which is incorporated by reference in Arata), Murphy et al. (US 2008/0208081 A1) and Park et al. (US 2009/0270868 A1).
Claim 1 provides a method of using a model to register a joint of a patient, fitting a representation of the implant using the model of the join while considering the soft tissue of the joint, and providing based on the planning a limit on movement of a surgical tool used to prepare the joint for the implant. Claim 10 is directed to a system to implement the method and comprises a processor and memory. It is noted that the method does not require the system, and that the method broadly does not require a processor or memory for modelling or planning. At the time of filing methods and proposed systems for making sure two bone implants were properly positioned were known as evidenced by Arata and Lavallee. More specifically, Arata discloses a surgical planning computerized method comprising: displaying a representation of a bone and a representation of a first implant component with respect to the representation of the bone (representing a first implant on a bone with a first implant model, see Figure 1e and [0046]-[0049]); displaying a representation of a second implant component, wherein the first implant component and the second implant component are physically separated and not connected to each other (representing a second implant on a bone with a second implant model, see Figure 1e and [0046]-[0049]); and preventing a positioning of the representation of the second implant component that violates at least one positioning constraint, wherein the positioning constraint is based on the representation of the first implant component (wherein when the component constraints are unacceptable the implant positions can be adjusted thereby preventing a representation wherein a constraint is violated, see [0048] and [0050]-[0054]). Arata further discloses the method of claim 1, wherein the at least one positioning constraint comprises a rigid constraint between the representation of the first implant component and the representation of the second implant component, wherein the rigid constraint prevents a positioning of the representation of the second implant component that is independent of the representation of the first implant component (Arata teaches maintaining relative positioning the implants and bones using defined matrix relationships, see [0044]-[0046], see [0162], [0172]-[0176] also Quiad US 2006/0142657 A1 which was incorporated by reference). Arata further discloses the method of claim 1, wherein the at least one positioning constraint comprises one or more axes of movement of the representation of the second implant component based on the representation of the first implant component (the positioning of the cap between the first and second model is adjusted by the surgeon to reposing the implant along at least one of the axes of movement of the implant, the implant is moved through an entire range move motion and then its position is adjusted if impingement is detect or if the model is in the improper position, see [0046]-[0048], by moving it along different axes of movement in the 3d model, Arata teaches monitoring the representation of a first and second implant through one or more axes of movement the a range of motion of the device, see Figures 11-13 and [0057]-[0060]). Arata further discloses the method wherein an axis from the one or more axes constrains a critical area between the representation of the first implant component and the representation of the second implant component (the one or more axes of rotation constrains the contact surface of the first and second implants to the desire curve, see Figures 11-13 and [0057]-[0060]). Arata further discloses the method wherein an axis from the one or more axes constrains a distance between the representation of the first implant component and the representation of the second implant component (the one or more axes of rotation constrains the contact surface of the first and second implants to the desire curve maintaining a desired distance, see Figures 11-13 and [0057]-[0060]). Arata further discloses the method wherein an axis from the one or more axes is based on an arc between the representation of the first implant component and the representation of the second implant component (the one or more axes of rotation constrains the contact surface of the first and second implants to the desire arc maintaining a desired distance, see Figures 11-13 and [0057]-[0060]). Arata further teaches wherein preventing comprises preventing a movement of the representation of the second component that is not a rotation around the one or more axes, a translation along the one or more axes, or any combination thereof (the bones an implants are modeled though a range of motion wherein the components are prevented from moving relative to one another according to a matrices which defines the models in space, see [0044]-[0046], see [0162], [0172]-[0176] also Quiad US 2006/0142657 A1 which is incorporated by reference). Arata teaches further comprising displaying a cross-sectional display at a cross-section point along an axis from the one or more axes (Arata teaches providing cross section along one or more axes of the implants, see Figures 3-9 and [0026], [0030], [0046] and [0052]), wherein the cross-sectional display comprises the representation of the first implant component, the representation of the second implant component, the representation of the bone, or any combination thereof (best shown in Figures 3-9). Arata teaches further comprising updating the cross-sectional display based on a new cross-section point along the axis (the device monitors and displays in real time and provides for looking a a plurality of angles, see Figures 3-9 and [0046]-[0059]). Arata further discloses the method, wherein the at least one positioning constraint is based on a representation of an extension of an articular surface of at least one of the first implant component and the second implant component (extension of a curve 113 of an engagement between the first and second surfaces, see Figures 11-13 and [0057]-[0060]) and further comprising determining an overlap of the representation of the extension of the articular surface and the representation of the first implant component, the representation of the second implant component, or any combination thereof (detecting a gap/overlap throughout a range of motion creating arc, see [0048]-[0055], extension of a curve 113 of an engagement between the first and second surfaces, see Figures 11-13 and [0057]-[0060]).
Arata further discloses the method further comprising displaying the representation of the extension of the articular surface (detecting a gap/overlap throughout a range of motion creating arc, see [0048]-[0055], extension of a curve 113 of an engagement between the first and second surfaces, see Figures 11-13 and [0057]-[0060]) and further discloses the method wherein displaying the representation of the second implant component comprises displaying the representation of the second implant component with respect to the representation of the bone (representing a second implant on a bone with a second implant model, see Figure 1e and [0046]-[0049], see Figures 11-13 and [0057]-[0060]). Arata further discloses the method wherein displaying the representation of the second implant component with respect to the representation of the bone further comprises displaying the representation of the second implant component based on at least one of a coordinate space of the representation of the bone or a coordinate space of the representation of the first implant component (See Figures 11-13 and [0057]-[0060[ viewing the implant and bones in 3D in real time though a range of motion defined by matrix relationships, see [0046]-[0049]). Arata further discloses the method further comprising displaying a change indicator (computer generated graph 600, figure 9 which shows the gap/overlaps analysis over a range of flexion angles [0055]), wherein the change indicator is based on a current location of the representation of the first implant component (the system monitors provide monitoring of the joint through a range of motion from 12.5 degrees to 108.5 degrees, see [0054] and [0048]-[0049]), see and at least one of an original location of the representation of the first implant component, a coordinate space of the representation of the bone, a coordinate space of the representation of the first implant component, or a coordinate space of a representation of cartilage (shows a change from a previous angle to a final angle, see Figure 9a and [0055]). Arata discloses a surgical planning computerized method comprising: displaying a representation of a bone and a representation of a first implant component with respect to the representation of the bone (representing a first implant on a bone with a first implant model, see Figure 1e and [0046]-[0049]); receiving data associated with a positioning of a representation of a second implant component, wherein the first implant component and the second implant component are physically separated and not connected to each other (the first and second implant are superimposed onto respective bones, and monitored though a range of movement, see [0044]-[0049]); comparing the data associated with the positioning of the representation of the second implant component with a positioning constraint that is based on the representation of the bone, the representation of the first implant component, or both (the joint is moved through an entire range of motion and analysis between the implants and bones is monitored, see [0046]-[0054] and [0057]-[0060]); and displaying the representation of the second implant component in accord with the data associated with the positioning of the representation of the second implant component if the data meets the positioning constraint (component (wherein when the component constraints are unacceptable the implant positions displayed can be adjusted thereby preventing a representation wherein a constraint is violated, see [0048] and [0050]-[0054], displaying a corrected data, see [0057]-[0065] and [0048]). Arata discloses a surgical planning system comprising: a computer (computing system 220, see Figure 14 and [0062]-[0072]) configured to: generate a display of a representation of a bone and a representation of a first implant component with respect to the representation of the bone representing a first implant on a bone with a first implant model, see Figure 1e and [0046]-[0049]); generate a display of a representation of a second implant component, wherein the first implant component and the second implant component are physically separated and not connected to each other (representing a second implant on a bone with a second implant model, see Figure 1e and [0046]-[0049]); and prevent a positioning of the representation of the second implant component that violates at least one positioning constraint, wherein the positioning constraint is based on the representation of the first implant component (wherein when the component constraints are unacceptable the implant positions can be adjusted thereby preventing a representation wherein a constraint is violated, see [0048] and [0050]-[0054]). Arata further discloses a surgical planning system comprising receiving data associated with a positioning of the representation of the second implant component (the system receives input of movement of the limb and its associated implant, wherein the implant position information can be input to move the implant, see [0041]-[0048]. Arata further discloses a surgical planning system wherein the computer is further configured to generate a user interface that enables a positioning of either the representation of the first implant component, the representation of the second implant component, or any combination thereof (see [0048] and [0065]). Arata discloses a computer program product, tangibly embodied in a computer readable medium, the computer program product including instructions being operable to cause a data processing apparatus to (the computer comprises a software which is run on a computer hard drive/memory, see [0062]-[0065]): display a representation of a bone and a representation of a first implant component with respect to the representation of the bone (representing a first implant on a bone with a first implant model, see Figure 1e and [0046]-[0049]); display a representation of a second implant component, wherein the first implant component and the second implant component are physically separated and not connected to each other (representing a second implant on a bone with a second implant model, see Figure 1e and [0046]-[0049]); and prevent a positioning of the representation of the second implant component that violates at least one positioning constraint, wherein the positioning constraint is based on the representation of the first implant component (wherein the computer system measures component constraints are unacceptable the implant positions can be adjusted thereby preventing a representation wherein a constraint is violated, see [0048] and [0050]-[0054]). Arata discloses a system comprising: displaying a representation of a bone and a representation of a first implant component with respect to the representation of the bone (displaying a first implant on a bone with a first implant model, see Figure 1e and [0046]-[0049]); displaying a representation of a second implant component, wherein the first implant component and the second implant component are physically separated and not connected to each other (displaying a first implant on a bone with a first implant model, see Figure 1e and [0046]-[0049]); and means for preventing a positioning of the representation of the second implant component that violates at least one positioning constraint, wherein the positioning constraint is based on the representation of the first implant component (the computer comprises a software which is run on a computer hard drive/memory, see [0062]-[0065]).
With respect to the teaching of Lavallee et al., similar to Arata, Lavallee discloses a surgical planning method (see Abstract and [0009]-[0013]) comprising: capturing data representative of a range of motion of a joint associated with a particular individual (reference point markers are attached to a patients bones, see [0010], and the range of motion of the bones is monitored in real time form the entire flexion range of motion, see [0095]), the joint comprising a first bone and a second bone (the knee joint and measuring the position of the femur relative to the tibia, see [0010] and Figure 1); representing the first bone of the joint (virtual implant is displayed on screen by superimposing on a first and second implant on images of the first and second bone of the joint, see [0010], [0012], [0073] and [0103]); associating a first implant model with the representation of the first bone (virtual implant is displayed on screen by superimposing on a first and second implant on images of the first and second bone of the joint, see [0010], [0012], [0073] and [0103]); based on the captured data, determining a relationship between the first implant model and a representation of the second bone through at least a portion of the range of motion of the joint (Once again, this dynamic process can be computed statically or in real time for the entire flexion range of motion. The surgeon can therefore flex and extend the knee with the distractor device in the joint, automatically adjusting the plateau heights as a function of the flexion angle and the position of the femur relative to the tibia as measured by the camera, and as a function of the planning of the virtual implants relative to the bone surface, see at least [0095]); and displaying information representative of the determined relationship (In addition, the pressure sensors can monitor the fluid pressure and display a value indicative of the normal force to the surgeon on the screen as they are flexing and extending the knee. The position of the femur 2 relative to the tibia 4 is also displayed, along with the gap distances and laxity values. Laxity values can be determined by measuring and storing the maximum lift-off or gap distance values between the virtual femoral and tibial implants, as the surgeon manipulates the joint. These values can be measured at a particular point, for example, at the deepest point of the tibial plateau. According to the feeling of the surgeon and/or the force values displayed, he or she can adjust the planned position of the virtual femoral implant relative to the femur 2. For example, the surgeon can position the implant more distally on the femur 2 using the buttons on the navigation system's tactile screen if he feels that the knee is too lax in extension. The surgeon can therefore use the quantitative laxity measurements displayed on the screen in order to make an informed decision as to the implant plan, see at least [0095]). Lavallee further discloses the method as set forth above, further comprising enabling a user to change a position of the first implant model (According to the feeling of the surgeon and/or the force values displayed, he or she can adjust the planned position of the virtual femoral implant relative to the femur 2. For example, the surgeon can position the implant more distally on the femur 2 using the buttons on the navigation system's tactile screen if he feels that the knee is too lax in extension. The surgeon can therefore use the quantitative laxity measurements displayed on the screen in order to make an informed decision as to the implant plan, see [0095]). Lavallee further discloses the method further comprising: associating the first implant model with the representation of the first bone based on the changed position Lavallee discloses the method wherein the virtual implants are superimposed on the bone structure which is displayed to a user, wherein in real time the user can monitor the range of motion and using buttons on the navigation systems tactile screen can adjust the position of the virtual implants, see [0095]; and based on the captured data, determining a relationship between the first implant model at its changed position and a representation of the second bone through at least a portion of the range of motion of the joint (The surgeon can evaluate any proposed component placement, continuously throughout the entire course of knee flexion, using both the laxity and force readouts on the screen and select the optimal one, see [0095]-[0097]). Lavallee further discloses the method as set forth above, wherein the representation of the second bone includes a representation of a surface of the second bone, a second implant model associated with the representation of the second bone, or both (see [0010]-[0011]). Lavallee further discloses the method wherein capturing comprises: tracking a position of the first bone and a position of the second bone; and recording the positions as the joint moves through the range of motion (the device displays the first and second bone and implants and allows the physician to monitor the movement of the bones and implants in real time as the joint is moved though a range of motion, see [0009]-[0012] and [0095]-[0097]). Lavallee further discloses the method as set forth above, further comprising: representing a position of the first implant model relative to a position of the representation of the second bone (the first and second implants are superimposed on the first and second bones of the joint, see [0010] and [0011]); and comparing the positions at any selected angle within the range of motion of the joint, inclusive (the surgeon can monitor in real time for the entire flexion range of motion of the femur and tibia as a function of the virtual implants, see [0095]-[0097]). Lavallee further discloses the method of representing a position of the first implant model relative to a position of a second implant model associated with the second bone (the first and second implants are superimposed on the first and second bones of the joint, see [0010] and [0011]); and comparing the positions at any selected angle within the range of motion of the joint, inclusive (the surgeon can monitor in real time for the entire flexion range of motion of the femur and tibia as a function of the virtual implants, see [0095]-[0097]). Lavallee further discloses the method as set forth above, further comprising: identifying an overlap, a gap, or both between the first implant model and the representation of the second bone or between the first implant model and a second implant model associated with the second bone at one or more angles within the range of motion of the joint, inclusive (first and second bones are displayed with the virtual surgical implants and are monitored over the entire flexion range of motion wherein the position of the femur relative to the tibia is also displayed along with the gap distances and laxity values between the implants as the surgeon manipulates the joint, see [0095] and [0010]-[0011]). Lavallee further discloses the method further comprising: wherein displaying comprises displaying a calculated measurement of the overlap, the gap, or both at any selected angle or at a plurality of angles within the range of motion of the joint, inclusive (see [0095]-[0097], the gap between the implants is displayed as the surgeon moves the joint though its range of motion). Lavallee further discloses the method wherein displaying comprises displaying of the overlap, the gap, or both in a representation of at least a portion of the joint at one or more angles within the range of motion of the joint, inclusive (see [0095]-[0097], the gap between the implants is displayed as the surgeon moves the joint though its range of motion, in real-–time when the joint is at various angles). Lavallee further discloses the method further comprising: mapping at least one point on a surface of the first implant model at a plurality of angles within the range of motion of the joint, inclusive; and aligning at least one of the mapped points with the representation of the second bone (Lavallee discloses the method wherein the tibia and femur and the implants are displayed to the user during real-time movement of the joint for the entire range of motion, wherein the user can monitor one bone relative to the other, thereby mapping the first implant and aligning it with the second bone to show movement, see [0010]-[0012] and [0095]-[0097], see also discussion of monitoring relative movement of the implants relative to one another, see [0067], [0073]-[0077] and [0085]-[0088]). Lavallee further discloses the method as set forth above, further comprising: associating a second implant model with the representation of the second bone based on at least one of the mapped points (see [0010]-[0012] wherein the implants are superimposed on the corresponding bone, and wherein the joint is monitored in real time, see [0095]-[0097]). Lavallee further discloses the method as set forth above, wherein capturing further comprises capturing data representative of a manipulation of the joint to achieve a desired internal/external angle, varus/valgus angle, flexion angle, or any combination thereof (as discussed in [0095]-[0097] the joint is manipulated through range of motion until the physician achieves the desire result by adjusting the position of the implants relative to each other and/or the bones). Lavallee further discloses the method as set forth above, further comprising enabling a user to manipulate placement of at least one implant model corresponding to at least a portion of an actual implant so that the determined relationship through at least a portion of the range of motion of the joint allows the desired internal/external angle, varus/valgus angle, flexion angle, or any combination thereof (the physician can move virtual implants on the bone structures to provide the desired range of motion of the joint, see [0010]-[0012], [0095]-[0097]). Lavallee discloses a surgical planning method, comprising the steps of: capturing data representative of a range of motion of a joint associated with a particular individual, the joint comprising a first bone and a second bone (the computer system uses a motion capture system see Figure 1, which detects the position of a tibia and femur see [0010]-[0012] and [0095]-[0097]); creating a representation of the joint comprising a representation of the first bone and a representation of the second bone (the joint is modeled in 3d, see [0072], see also [0010]-[0012] and [0095]-[0097]); superimposing a first implant model on the representation of the first bone and a second implant model on the representation of the second bone; based on the captured data (the first and second virtual implant modes are imposed on the first and second bones, see [0011]), displaying the representations of the first and second bones as the representation of the joint moves through the range of motion (the joint is monitored in real time while the joint is moved though a range of motion, see [0095[]-[0097] to determine a relationship between the first and second implant models; and adjusting a size, a shape, a position, or any combination thereof of the first implant model, the second implant model, or both based on the determined relationship (the system provides a display 30 and 32 which allows the user to view in real time the motion of the joint (bones and implants) and displays information regarding motion captured data allowing the user to adjust the implant position though a user interface, see [0010]-[0012] and [0095]-[0097] and [0074]). Lavallee discloses a surgical computing system comprising (computer assisted surgery system, see Figure 1 comprising a computer to plan a surgical procedure, see abstract and [0009]):a computer (see Figure 1, abstract and [0009]) configured to: capture data representative of a range of motion of a joint associated with a particular individual (the system use a motion capturing system see Figure 1, which monitors the movement of a patients joint, see [0009]-[0012] and [0095]-[0097]); represent a first bone of the joint; associate a first implant model with the representation of the first bone (the system models the first bone and superimposes a first implant over the bone, see [0010]-[0012] and [0095]-[0097]); and based on the captured data, determine a relationship between the first implant model and a representation of a second bone of the joint through at least a portion of the range of motion of the joint (real-time monitoring of the joint is done and displays feedback to the user on the bones and virtual implant positions during the range of motion as the user manipulates the joint). Lavallee further discloses the system further comprising a tracking system in communication with the computer, the tracking system including a detection device and one or more trackers which each include a coupling means to couple the tracker to a bone of the joint (The system 10 includes a suitable position measuring device 20 that can accurately measure the position of marking elements in three dimensional space. The position measuring device 20 can employ any type of position measuring method as may be known in the art, for example, emitter/detector or reflector systems including optic, acoustic or other wave forms, shape based recognition tracking algorithms, or video-based, mechanical, electromagnetic and radio frequency systems. [0029]In a preferred embodiment, schematically shown in FIG. 1, the position measuring system 20 is an optical tracking system that includes at least one camera that is in communication with a computer system 30 and is positioned to detect light reflected from a number of special light reflecting markers, spheres or discs 50, see [0028] and [0029]). Lavallee further discloses the system further comprising a display in communication with the computer and configured to display information received from the computer that is representative of the determined relationship (as best shown in Figure 1 the system comprises a display to present the data, see [0030],[0033] and [0064]). Lavallee further discloses the system as set forth above, wherein the computer is further configured to generate a user interface that enables a user to select an angle at which the determined relationship is calculated, displayed, or both (the system comprises a touch screen, see [0033], the system having buttons to change the implant position, threshold values which result in the program adjusting the position of the elements to maintain parameters, and allowing the user to rotate the bones, move contact points and move components allowing the surgeon to simulate different movement of the bones and implants relative to one another in order to determine an optimum plan, see [0095]-[0097]). Lavallee further discloses the system, wherein the computer is further configured to generate a user interface that enables a user to change a position of the first implant model (the system comprises a touch screen, see [0033], the system having buttons to change the implant position, see [0095]). Lavallee discloses a computer program product (software on a computer system, see Abstract and [0009]) embodied in an information carrier, the computer program product including instructions being operable to cause a data processing apparatus to: capture data representative of a range of motion of a joint associated with a particular individual, the joint comprising a first bone and a second bone (the computer system uses a motion capture system see Figure 1, which detects the position of a tibia and femur see [0010]-[0012] and [0095]-[0097]); represent the first bone of the joint (the joint is modeled in 3d, see [0072]); associate a first implant model with the representation of the first bone (first and second implants ca/are associated with corresponding bones, see [0010]-[0012] and [0095]-[0097]); determine a relationship between the first implant model and a representation of the second bone through at least a portion of the range of motion of the joint based on the captured data (the implant and bones are modeled though a range of motion, see [0095]-[0097]);
optionally associate a second implant model with the representation of the second bone (a second implant is associated with the second bone see [0010]-[0012] and [0095]-[0097]); and
display information representative of the determined relationship (the system provides a display 30 and 32 which allows the user to view in real time the motion of the joint (bones and implants) and displays information regarding motion captured data, see [0010]-[0012] and [0095]-[0097] and [0074]). Lavallee discloses a computer program product (software see abstract and [0009], and [0074]), embodied in an information carrier, the computer program product including instructions being operable to cause a data processing apparatus to: capturing data representative of a range of motion of a joint associated with a particular individual, the joint comprising a first bone and a second bone (the computer system uses a motion capture system see Figure 1, which detects the position of a tibia and femur see [0010]-[0012] and [0095]-[0097]); creating a representation of the joint comprising a representation of the first bone and a representation of the second bone (the joint is modeled in 3d, see [0072], see also [0010]-[0012] and [0095]-[0097]); superimposing a first implant model on the representation of the first bone and a second implant model on the representation of the second bone; based on the captured data (the first and second virtual implant modes are imposed on the first and second bones, see [0011]),
displaying the representations of the first and second bones as the representation of the joint moves through the range of motion (the joint is monitored in real time while the joint is moved though a range of motion, see [0095[]-[0097] to determine a relationship between the first and second implant models; and adjusting a size, a shape, a position, or any combination thereof of the first implant model, the second implant model, or both based on the determined relationship (the system provides a display 30 and 32 which allows the user to view in real time the motion of the joint (bones and implants) and displays information regarding motion captured data allowing the user to adjust the implant position though a user interface allowing the user to reposition the virtual joints during diagnosis to determine the best plan for surgery, see [0010]-[0012] and [0095]-[0097] and [0074]).
As discussed above in summarizing the teaching of Arata, Quaid et al. (US 2006/0142657 A1, is incorporated by reference in Arata. More specifically with respect ot the instantly claimed method and system, Quaid teaches a surgical system comprising calculating a plurality of areas representing cartilage (a height of a cartilage surface above a bone is detected and a representation of the bone and cartilage surface is created wherein the cartilage surfaces is made of a plurality of points, see [0209] and [0220]); and a positioning of the representation of the first implant component that coincides with a second positioning constraint that is based on the plurality of areas representing cartilage (the implant models is aligned with the mapped points of the cartilage to ensure proper placement of the implant, see [0209], thereby preventing improper installation).
It would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the method taught by Arata to include viewing various images from different angles as taught by Murphy in order to view implant fit and positioning form multiple angles to ensure good fit. It would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the method taught by Arata in view of Murphy to include multiple sliced cross sectional view as taught by Park in order to in order to ensure good fit and positioning at multiple points through the implant.
Conclusion
No claim is allowed.
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/Joseph Woitach/Primary Examiner, Art Unit 1687
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