DETAILED ACTION
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/06/2026 has been entered.
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 Amendment
In light of the amendments, the previous 35 U.S.C. 112(b) rejections are withdrawn.
In light of the amendments, claims 1-3, 6-7, 9-13, and 16-23 are rejected under 35 U.S.C. 112(b).
In light of the amendments, claims 1-3, 6-7, 9-13, 16-25, and 28 are rejected under 35 U.S.C. 112(a).
In light of the amendments, the claims are rejected under 35 U.S.C. 101.
In light of the amendments, the claims are rejected under 35 U.S.C. 103.
Notice to Applicant
In the amendment dated 08/06/2026, the following has occurred: claims 1, 24-25, and 28 have been amended; claims 4-5, 8, 14-15, and 26-27 have been canceled; claims 2-3, 6-7, 9-13, and 16-23 have remained unchanged; and no new claims have been added.
Claims 1-3, 6-7, 9-13, 16-25, and 28 are pending.
Effective Filing Date: 09/09/2022
Response to Arguments
35 U.S.C. 112(b) Rejections:
Applicant has overcome the previous 112(b) rejections via amendments to the claims. Examiner withdraws these previous rejections.
35 U.S.C. 101 Rejections:
Step 2A, Prong One:
Applicant argues that the amended claims are not directed toward an abstract idea. Applicant points to McRO and states that the present analysis is oversimplifying the claims. Applicant further states that the claim limitations are not directed towards mental processes and are instead directed to a specific improvement in how a computer simulates and visualizes complex biomechanical data. Examiner however respectfully disagrees. The claims recite a computerization of a visualization process, where the visualization process is the abstract idea. For example, a person can simulate the center of rotation for a joint before and after an implant. It can be done using a physical model or even on paper. As stated above, the specific improvement to how a computer is simulating and visualizing this is not appreciated in the claims. How is it being improved in the specification and is there a nexus between the specification and the claims? The specification eludes to the improvement being towards the prediction of post-operative mobility and stability in paragraph [0038] of the specification. The improvement appears to be directed towards the prediction and not an improvement in how a computer simulates and visualizes data.
Step 2A, Prong Two:
Applicant argues that there is a practical application as there is a tangible improvement to a technological process. Conventional planning tools do not provide a solution for predicting and visualizing the functional consequences of this specific biomechanical change. Examiner however respectfully disagrees. Initially, providing a model which provides actionable data in order to improve a surgical process does not guarantee an improved surgical process. The surgery itself is not necessarily being improved. Furthermore, the claims do not include sufficient additional elements which integrate with abstract idea into a practical application. The claims include additional elements which apply the abstract idea using generic computing components.
Step 2B:
Applicant argues that the claims recite significantly more than the abstract idea. Applicant further states that there is a specific implementation that solves a technical problem in a new way. Examiner however respectfully disagrees. The improvement here appears to be towards improving the surgeon’s ability to select implant design, size, and placement which can be seen as an improvement, but an improvement to an abstract idea involving joint modeling (visualization) and implant selection (which does not technically occur in the claims).
35 U.S.C. 102/103 Rejections:
Applicant argues with respect to the amended claim limitations. These limitations have been addressed using additional art.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 6-7, 9-13, 16-25, and 28 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1, 24, and 28 recite using a center of rotation which is medialized relative to a native center of rotation. This limitation is not described within the specification as such, leading Examiner to question whether Applicant had possession over the claimed invention at the time of filing.
Claims 2-3, 6-7, 9-13, 16-23, and 25 are rejected based on their dependency on claims 1 and 24.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 6-7, 9-13, and 16-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the location” in lines 16-17. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-3, 6-7, 9-13, and 16-23 are rejected based on their dependency on claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 6-7, 9-13, 16-25, and 28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-3, 6-7, 9-13, and 16-23 are drawn to a method, claims 24-25 are drawn to a system, and claim 28 is drawn to a system, each of which is within the four statutory categories. Claims 1-3, 6-7, 9-13, 16-25, and 28 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES).
Step 2A:
Prong One:
Claim 1 recites a method for performing pre-operative planning of a reverse total arthroplasty surgery comprising:
1) deriving, using a) at least one processor, a patient-specific three-dimensional model of the anatomy of a shoulder joint to be replaced from images gathered from one or more of devices selected from a CT device, an MRI device, and an ultrasound device;
2) receiving a selection of a planned placement of a reverse shoulder implant on the patient-specific three-dimensional model, wherein the planned placement defines a planned center of rotation that is medialized relative to a native center of rotation of the shoulder joint;
3) analyzing and visualizing, using the at least one processor on the model of the joint, a range-of-motion of the joint for the selected implant and placement of the implant;
4) simulating, using the at least one processor, post-operative muscle function based on the medialized planned center of rotation during activities of daily living; and
5) providing, on b) a graphical user interface, a visualization of a change in the location of a center of rotation of the shoulder joint from the native center of rotation to the medialized planned center of rotation in conjunction with the simulated post-operative muscle function.
Claim 1 recites, in part, performing the steps of 1) deriving a patient-specific three-dimensional model of the anatomy of a shoulder joint to be replaced from images gathered from one or more of devices selected from a CT device, an MRI device, and an ultrasound device, 2) receiving a selection of a planned placement of a reverse shoulder implant on the patient-specific three-dimensional model, wherein the planned placement defines a planned center of rotation that is medialized relative to a native center of rotation of the shoulder joint, 3) analyzing and visualizing, on the model of the joint, a range-of-motion of the joint for the selected implant and placement of the implant, 4) simulating post-operative muscle function based on the medialized planned center of rotation during activities of daily living, and 5) providing a visualization of a change in the location of a center of rotation of the shoulder joint from the native center of rotation to the medialized planned center of rotation in conjunction with the simulated post-operative muscle function. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, people can determine a model reflecting joint movement based upon data and share that model.
Claim 24 recites a system for performing pre-operative planning of joint replacement surgery comprising:
a) a processor; and
c) software that, when executed on the processor, causes the system to perform the functions of:
6) providing a workflow, the workflow accepting as input patient-specific imaging of anatomy of a joint to be replaced using an implant from one or more imaging modalities;
7) deriving, from the one or more of devices selected from a CT device, an MRI device, and an ultrasound device, a model of the joint;
8) providing d) an application for analyzing and visualizing on the model a range-of-motion of the joint for a particular implant and placement of components of the implant on the anatomy of the joint;
9) simulating post-operative muscle function based on a medialized planned center of rotation during activities of daily living; and
10) providing, on b) a graphical user interface, a visualization of a change in a location of a center of rotation of the joint from the native center of rotation to the medialized planned center of rotation in conjunction with the simulated post-operative muscle function.
Claim 24 recites, in part, performing the steps of 6) providing a workflow, the workflow accepting as input patient-specific imaging of anatomy of a joint to be replaced using an implant from one or more imaging modalities, 7) deriving, from the one or more of devices selected from a CT device, an MRI device, and an ultrasound device, a model of the joint, 8) providing something for analyzing and visualizing on the model a range-of-motion of the joint for a particular implant and placement of components of the implant on the anatomy of the joint, 9) simulating post-operative muscle function based on a medialized planned center of rotation during activities of daily living, and 10) providing a visualization of a change in a location of a center of rotation of the joint from the native center of rotation to the medialized planned center of rotation in conjunction with the simulated post-operative muscle function. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). For example, people can determine a model reflecting joint movement based upon data and share that model.
Claim 28 recites a system for performing pre-operative planning of joint replacement surgery comprising:
a) a processor; and
c) software that, when executed on the processor, causes the system to perform the functions of:
11) providing a workflow, the workflow accepting as input patient-specific imaging of anatomy of a joint to be replaced using an implant from one or more of devices selected from a CT device, an MRI device, and an ultrasound device;
12) deriving, from the one or more imaging modalities, a patient-specific three-dimensional model of the joint;
13) providing d) an application for analyzing and visualizing the model and a location of a center of rotation of the joint on the model;
14) simulating post-operative muscle function based on a medialized planned center of rotation during activities of daily living; and
15) providing a visualization of a change in a location of a center of rotation of the joint from the native center of rotation to the medialized planned center of rotation in conjunction with the simulated post-operative muscle function,
wherein the visualization of the model comprises one or more muscles displayed on the model.
Claim 28 recites, in part, performing the steps of 11) providing a workflow, the workflow accepting as input patient-specific imaging of anatomy of a joint to be replaced using an implant from one or more of devices selected from a CT device, an MRI device, and an ultrasound device, 12) deriving, from the one or more imaging modalities, a patient-specific three-dimensional model of the joint, 13) providing something for analyzing and visualizing the model and a location of a center of rotation of the joint on the model, 14) simulating post-operative muscle function based on a medialized planned center of rotation during activities of daily living, and 15) providing a visualization of a change in a location of a center of rotation of the joint from the native center of rotation to the medialized planned center of rotation in conjunction with the simulated post-operative muscle function, wherein the visualization of the model comprises one or more muscles displayed on the model. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, people can determine a model reflecting joint movement based upon data and share that model.
Depending claims 2-3, 6-7, 9-13, 16-23, and 25 include all of the limitations of claims 1, 24, and 28, and therefore likewise incorporate the above described abstract idea. Depending claim 3 adds the additional step of “providing an animated visualization of the model through a range-of-motion for each major axis of rotation; wherein: the animated visualization automatically moves the model through the ranges-of-motion; or the animated visualization is controlled using a manual input of the ranges-of-motion”, claim 6 adds the additional step of “providing a graphical visualization of the range-of-motion with respect to each of the three axes of motion”; claim 9 adds the additional step of “providing one or more views of the imagery from which the model was derived showing placement of components of the implant thereon”; claim 10 adds the additional step of “providing an animated visualization of the ranges-of-motion of the model required for performance of one or more activities of daily living”; claim 11 adds the additional step of “informing the user of parts of the bone and/or the implant that are impinging or colliding during range-of-motion visualizations”; claim 12 adds the additional step of “highlighting parts of the patient's anatomy where impingement occurs”, claim 13 adds the additional steps of “providing a graphical visualization of the ranges-of-motion with respect to each of the three axes of rotation for the one or more activities of daily living” and “providing a selection mechanism for selecting the activity of daily living to be animated”; claim 17 adds the additional step of “providing a selection mechanism for selecting the one or more muscles to be visualized on the model”; claim 18 adds the additional step of “providing a graphical visualization of the moment arm of one or more muscles selected with the selection mechanism”; claim 19 adds the additional step of “providing a graphical visualization of the force-length curve through relevant ranges-of-motion for the one or more muscles selected with the selection mechanism”; claim 20 adds the additional step of “receiving a selection of one or more additional implant models and placement of the models on the patient's anatomy”; claim 21 adds the additional step of “providing a comparison between the originally-selected implant model and the one or more additional selected implant models”; claim 22 adds the additional step of “providing a graphical visualization of the range-of-motion with respect to each of the three axes of rotation for each of the selected implant models”; claim 23 adds the additional step of “providing suggestions of one or more implant positions that optimize certain parameters such as muscle moment arm, force-length curve, or minimal impingement”; and claim 25 adds the additional step of “providing an application for analyzing and visualizing a range-of-motion of the joint required for performance of one or more activities of daily living, wherein the visualization of the model comprises one or more muscles displayed on the model.” Additionally, the limitations of depending claims 2, 7, and 16 further specify elements from the claims from which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Thus, depending claims 2-3, 6-7, 9-13, 16-23, and 25 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 24, and 28 (Step 2A (Prong One): YES).
Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of – using a) a processor, b) a graphical user interface, c) software that, when executed on the processor, causes the system to perform the functions, and d) an application to perform the claimed steps.
The a) processor, b) graphical user interface, c) software, and d) application in these steps are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that they amount to no more than mere instructions to apply the exception using generic computer components (see: Applicant’s specification, paragraph [0081] where there are generic computing components for these elements, see MPEP 2106.05(f)).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea (Step 2A (Prong Two): NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a) a processor, b) a graphical user interface, c) a software, and d) an application to perform the claimed steps amounts to no more than mere instructions to apply the exception using generic computer components that do not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain method steps of organizing human activity. Specifically, MPEP 2106.05(f) recites that the following limitations are not significantly more:
Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)).
The current invention analyzes and visualizes a range-of-motion utilizing a) a processor, b) a graphical user interface, c) a software, and d) an application, thus these computing components are adding the words “apply it” with mere instructions to implement the abstract idea on a computer.
Mere instructions to apply an exception using generic computer components cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO).
Claims 1-3, 6-7, 9-13, 16-25, and 28 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 1-3, 6-7, 10-13, 16, 20, 24-25, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2021/0315642 to McGuan et al. in view of U.S. 2023/0146371 to Gargac et al.
As per claim 1, McGuan et al. teaches a method for performing pre-operative planning of a reverse total arthroplasty surgery comprising:
--deriving, using at least one processor, a patient-specific three-dimensional model of the anatomy of a shoulder joint to be replaced from images gathered from one or more of devices selected from a CT device, an MRI device, and an ultrasound device; (see: paragraph [0205] where there is acquisition of a 3D representation of the patient’s relevant body anatomy. A series of cartesian coordinates are being captured which represent the tissue surface. Also see: paragraph [0058] where the joint can be a shoulder joint. Also see: paragraph [0076] where there are multiple image modalities including CT, MRI, and ultrasound. These modalities were received from devices)
--receiving a selection of a planned placement of an implant on the patient-specific three-dimensional model; (see: paragraph [0206] where there is a determination of an optimal orientation and position of the implants to achieve the best outcome. Also see: paragraphs [0219] and [0222] where implant characteristics are included as part of the initial states and positions/orientations which are both selected)
--analyzing and visualizing, using the at least one processor on the model of the joint, a range-of-motion of the joint for the selected implant and placement of the implant; (see: paragraph [0222] where there is analysis and output of a visual depiction of hip activity using a processor executing a software. The software can simulate the positions and orientations of the implants in relation to the bony anatomy)
--simulating, using at least the one processor, post-operative muscle function during activities of daily living; (see: paragraph [0149] where there is simulation of post-operative ranges of motion for the implant during activities such as walking. Also see: paragraph [0303]) and
--providing, on a graphical user interface, a visualization of a change in the location of a center of rotation of the shoulder joint (see: paragraph [0085] where there is proposed surgical plan which includes details on a center of rotation of the joint. Also see: paragraphs [0108] and [0118] where updates to the plan are being displayed as changes happen to it in real-time, and there is a display of the changes to the position and orientation of implants. Also see: paragraph [0058] where the joint can be a shoulder joint. Therefore the display here would also show the updated location of a center of rotation of the shoulder joint).
McGuan et al. may not further, specifically teach:
1) --a planned placement of a reverse shoulder implant on the patient-specific three-dimensional model, wherein the planned placement defines a planned center of rotation that is medialized relative to a native center of rotation of the shoulder joint;
2) --simulating, using at least the one processor, post-operative muscle function based on the medialized planned center of rotation; and
3) --a center of rotation of the shoulder joint from the native center of rotation to the medialized planned center of rotation in conjunction with the simulated post-operative muscle function.
Gargac et al. teaches:
1) --a planned placement of a reverse shoulder implant on the patient-specific three-dimensional model, (see: paragraph [0002] where there is a reverse shoulder arthroplasty with an implant. Also see: paragraph [0019] where there is planning of placement for this implant) wherein the planned placement defines a planned center of rotation that is medialized relative to a native center of rotation of the shoulder joint; (see: paragraph [0120] where there is a determined center of rotation relative to the center of the should joint. The planned placement involves the virtual center of rotation of the joint as well as the size, position, and orientation of the implant. The projected center of rotation here is relative to the native center of rotation here, thus is it medialized with respect to the native center of rotation)
2) --simulating, using at least the one processor, post-operative muscle function based on the medialized planned center of rotation; (see: paragraph [0120] where there is a projected range of motion of the repaired joint which is a simulation of the post-operative muscle function based on the center of rotation above)
3) --a center of rotation of the shoulder joint from the native center of rotation to the medialized planned center of rotation in conjunction with the simulated post-operative muscle function (see: paragraph [0120] where there is a projected range of motion of the repaired joint which is a simulation of the post-operative muscle function based on the center of rotation above).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have 1) a planned placement of a reverse shoulder implant on the patient-specific three-dimensional model, wherein the planned placement defines a planned center of rotation that is medialized relative to a native center of rotation of the shoulder joint, 2) simulate, using at least the one processor, post-operative muscle function based on the medialized planned center of rotation, and use 3) a center of rotation of the shoulder joint from the native center of rotation to the medialized planned center of rotation in conjunction with the simulated post-operative muscle function as taught by Gargac et al. in the method as taught by McGuan et al. with the motivation(s) of improving a range of motion of the joint (see: paragraph [0017] of Gargac et al.).
As per claim 2, McGuan et al. and Gargac et al. in combination teaches the method of claim 1, see discussion of claim 1. McGuan et al. further teaches:
--visualizing the placement of the implant on the model of the joint (see: paragraph [0222] and FIG. 12D where there is visualization of the placement of the implant in the joint).
As per claim 3, McGuan et al. and Gargac et al. in combination teaches the method of claim 1, see discussion of claim 1. McGuan et al. further teaches:
--providing an animated visualization of the model through a range-of-motion for each major axis of rotation; (see: paragraph [0225] where there is an animation for the visualization. This would include all ranges of motion, i.e. each major axis of rotation)
--wherein:
--the animated visualization automatically moves the model through the ranges-of-motion; (see: paragraph [0225] where there is automated visualization of different physical activities) or
--the animated visualization is controlled using a manual input of the ranges-of-motion (see: above).
As per claim 6, McGuan et al. and Gargac et al. in combination teaches the method of claim 1, see discussion of claim 1. McGuan et al. further teaches:
--providing a graphical visualization of the range-of-motion with respect to each of the three axes of motion (see: paragraph [0222] and FIG. 12A where there is providing a graphical visualization of the range-of-motion with respect to the axes of motion).
As per claim 7, McGuan et al. and Gargac et al. in combination teaches the method of claim 6, see discussion of claim 6. McGuan et al. further teaches wherein the graphic visualization of the ranges-of-motion is one of a graph and an animated skeletal representation of the joint (see: FIGS. 12A and 12D where there is a graphical visualization of the motion and an animated skeleton).
As per claim 10, McGuan et al. and Gargac et al. in combination teaches the method of claim 1, see discussion of claim 1. McGuan et al. further teaches:
--providing an animated visualization of the ranges-of-motion of the model required for performance of one or more activities of daily living (see: paragraph [0225] where there an animated visualization which is provided of the motion for various activities).
As per claim 11, McGuan et al. and Gargac et al. in combination teaches the method of claim 1, see discussion of claim 1. McGuan et al. further teaches:
--informing the user of parts of the bone and/or the implant that are impinging or colliding during range-of-motion visualizations (see: paragraph [0224] where there is informing of impingement).
As per claim 12, McGuan et al. and Gargac et al. in combination teaches the method of claim 11, see discussion of claim 11. McGuan et al. further teaches:
--highlighting parts of the patient's anatomy where impingement occurs (see: paragraphs [0224] and [0323] where there is highlighting of impingement).
As per claim 13, McGuan et al. and Gargac et al. in combination teaches the method of claim 1, see discussion of claim 1. McGuan et al. further teaches:
--providing a graphical visualization of the ranges-of-motion with respect to each of the three axes of rotation for the one or more activities of daily living and providing a selection mechanism for selecting the activity of daily living to be animated (see: paragraph [0222] where the ranges of motion are displayed for activities that a patient may experience post-surgery).
As per claim 16, McGuan et al. and Gargac et al. in combination teaches the method of claim 1, see discussion of claim 1. McGuan et al. further teaches wherein the visualization of the model comprises one or more muscles visualized on the model (see: paragraph [0075] where there is display of a muscle using the modeling software. Also paragraph [0366] where there is consideration of deep knee bends, where the primary force is from exterior muscles).
As per claim 20, McGuan et al. and Gargac et al. in combination teaches the method of claim 1, see discussion of claim 1. McGuan et al. further teaches:
--receiving a selection of one or more additional implant models and placement of the models on the patient's anatomy (see: claim 35 and paragraph [0007] where there are a plurality of implants which are selected).
As per claim 24, McGuan et al. teaches a system for performing pre-operative planning of joint replacement surgery comprising:
--a processor; (see: paragraph [0009] where there is a processor) and
--software that, when executed on the processor, causes the system to perform the functions (see: paragraph [0030] where there is a modeling software) of:
--providing a workflow, the workflow accepting as input patient-specific imaging of anatomy of a joint to be replaced using an implant from one or more imaging modalities; (see: paragraph [0205] where there is acquisition of a 3D representation of the patient’s relevant body anatomy. A series of cartesian coordinates are being captured which represent the tissue surface. Also see: paragraph [0076] where there are multiple image modalities)
--deriving, from the one or more of devices selected from a CT device, an MRI device, and an ultrasound device, a patient-specific three-dimensional model of the joint; (see: paragraph [0206] where there is a determination of an optimal orientation and position of the implants to achieve the best outcome. Also see: paragraphs [0219] and [0222] where implant characteristics are included as part of the initial states and positions/orientations which are both selected. Also see: paragraph [0076] where there are multiple image modalities including CT, MRI, and ultrasound. These modalities were received from devices. A model of a joint is being derived here and then being used for visualization)
--providing an application for analyzing and visualizing on the model a range-of-motion of the joint for a particular implant and placement of components of the implant on the anatomy of the joint; (see: paragraph [0222] where there is analysis and output of a visual depiction of hip activity using a software. The software can simulate the positions and orientations of the implants in relation to the bony anatomy. An application is being provided for this analysis and visualization)
--simulating post-operative muscle function during activities of daily living; (see: paragraph [0149] where there is simulation of post-operative ranges of motion for the implant during activities such as walking. Also see: paragraph [0303]) and
--providing, on a graphical user interface, a visualization of a change in a location of a center of rotation of the joint (see: paragraph [0085] where there is proposed surgical plan which includes details on a center of rotation of the joint. Also see: paragraphs [0108] and [0118] where updates to the plan are being displayed as changes happen to it in real-time, and there is a display of the changes to the position and orientation of implants. Therefore the display here would also show the updated location of a center of rotation of the joint).
McGuan et al. may not further, specifically teach:
1) --simulating post-operative muscle function based on a medialized planned center of rotation; and
2) --a center of rotation of the joint from the native center of rotation to the medialized planned center of rotation in conjunction with the simulated post-operative muscle function.
Gargac et al. teaches:
1) --simulating post-operative muscle function based on a medialized planned center of rotation; (see: paragraph [0120] where there is a projected range of motion of the repaired joint which is a simulation of the post-operative muscle function based on the center of rotation. The projected center of rotation here is relative to the native center of rotation here, thus is it medialized with respect to the native center of rotation)
2) --a center of rotation of the joint from the native center of rotation to the medialized planned center of rotation in conjunction with the simulated post-operative muscle function (see: paragraph [0120] where there is a projected range of motion of the repaired joint which is a simulation of the post-operative muscle function based on the center of rotation above).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to 1) simulate post-operative muscle function based on a medialized planned center of rotation and use 2) a center of rotation of the joint from the native center of rotation to the medialized planned center of rotation in conjunction with the simulated post-operative muscle function as taught by Gargac et al. in the system as taught by McGuan et al. with the motivation(s) of improving a range of motion of the joint (see: paragraph [0017] of Gargac et al.).
As per claim 25, McGuan et al. and Gargac et al. in combination teaches the system of claim 24, see discussion of claim 24. McGuan et al. further teaches wherein the software causes the system to perform:
--providing an application for analyzing and visualizing a range-of-motion of the joint required for performance of one or more activities of daily living; (see: paragraph [0225] where there an animated visualization which is provided of the motion for various activities)
--wherein the visualization of the model comprises one or more muscles displayed on the model (see: paragraph [0075] where there is display of a muscle using the modeling software. Also paragraph [0366] where there is consideration of deep knee bends, where the primary force is from exterior muscles).
As per claim 28, McGuan et al. teaches a system for performing pre-operative planning of joint replacement surgery comprising:
--a processor; (see: paragraph [0009] where there is a processor) and
--software that, when executed on the processor, causes the system to perform the functions (see: paragraph [0030] where there is a modeling software) of:
--providing a workflow, the workflow accepting as input patient-specific imaging of anatomy of a joint to be replaced using an implant from one or more of devices selected from a CT device, an MRI device, and an ultrasound device; (see: paragraph [0205] where there is acquisition of a 3D representation of the patient’s relevant body anatomy. A series of cartesian coordinates are being captured which represent the tissue surface. Also see: paragraph [0076] where there are multiple image modalities including CT, MRI, and ultrasound. These modalities were received from devices)
--deriving, from the one or more imaging modalities, a patient-specific three-dimensional model of the joint; (see: paragraph [0206] where there is a determination of an optimal orientation and position of the implants to achieve the best outcome. Also see: paragraphs [0219] and [0222] where implant characteristics are included as part of the initial states and positions/orientations which are both selected. A model of a joint is being derived here and then being used for visualization)
--providing an application for analyzing and visualizing the model and a location of a center of rotation of the joint on the model; (see: paragraph [0222] where there is analysis and output of a visual depiction of hip activity using a software. The software can simulate the positions and orientations of the implants in relation to the bony anatomy. An application is being provided for this analysis and visualization)
--simulating post-operative muscle function during activities of daily living; (see: paragraph [0149] where there is simulation of post-operative ranges of motion for the implant during activities such as walking. Also see: paragraph [0303]) and
--providing a visualization of a change in a location of a center of rotation of the joint; (see: paragraph [0085] where there is proposed surgical plan which includes details on a center of rotation of the joint. Also see: paragraphs [0108] and [0118] where updates to the plan are being displayed as changes happen to it in real-time, and there is a display of the changes to the position and orientation of implants. Therefore the display here would also show the updated location of a center of rotation of the joint)
--wherein the visualization of the model comprises one or more muscles displayed on the model (see: paragraph [0075] where there is display of a muscle using the modeling software. Also paragraph [0366] where there is consideration of deep knee bends, where the primary force is from exterior muscles).
McGuan et al. may not further, specifically teach:
1) --simulating post-operative muscle function based on a medialized planned center of rotation; and
2) --a center of rotation of the joint from the native center of rotation to the medialized planned center of rotation in conjunction with the simulated post-operative muscle function.
Gargac et al. teaches:
1) --simulating post-operative muscle function based on a medialized planned center of rotation; (see: paragraph [0120] where there is a projected range of motion of the repaired joint which is a simulation of the post-operative muscle function based on the center of rotation. The projected center of rotation here is relative to the native center of rotation here, thus is it medialized with respect to the native center of rotation)
2) --a center of rotation of the joint from the native center of rotation to the medialized planned center of rotation in conjunction with the simulated post-operative muscle function (see: paragraph [0120] where there is a projected range of motion of the repaired joint which is a simulation of the post-operative muscle function based on the center of rotation above).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to 1) simulate post-operative muscle function based on a medialized planned center of rotation and use 2) a center of rotation of the joint from the native center of rotation to the medialized planned center of rotation in conjunction with the simulated post-operative muscle function as taught by Gargac et al. in the system as taught by McGuan et al. with the motivation(s) of improving a range of motion of the joint (see: paragraph [0017] of Gargac et al.).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2021/0315642 to McGuan et al. in view of U.S. 2023/0146371 to Gargac et al. as applied to claim 1, and further in view of U.S. 2023/0210402 to Sun et al.
As per claim 9, McGuan et al. and Gargac et al. in combination teaches the method of claim 1, see discussion of claim 1. The combination may not further, specifically teach:
--providing one or more views of the imagery from which the model was derived showing placement of components of the implant thereon.
Sun et al. teaches:
--providing one or more views of the imagery from which the model was derived showing placement of components of the implant thereon (see: paragraphs [0072] and [0108] where there is providing of the 3D image model in addition to the original images).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to provide one or more views of the imagery from which the model was derived showing placement of components of the implant thereon as taught by Sun et al. in the method as taught by McGuan et al. and Gargac et al. in combination with the motivation(s) of improving the visual representation of an item (see: paragraph [0095] of Sun et al.).
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2021/0315642 to McGuan et al. in view of U.S. 2023/0146371 to Gargac et al. as applied to claim 1, and further in view of U.S. 2023/0210402 to Su et al.
As per claim 17, McGuan et al. and Gargac et al. in combination teaches the method of claim 16, see discussion of claim 16. The combination may not further specifically teach:
--providing a selection mechanism for selecting the one or more muscles to be visualized on the model.
Su et al. teaches:
--providing a selection mechanism for selecting the one or more muscles to be visualized on the model (see: FIG. 32 where there is a selection mechanism for selecting muscle groups).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to provide a selection mechanism for selecting the one or more muscles to be visualized on the model as taught by Su et al. in the method as taught by McGuan et al. and Gargac et al. in combination with the motivation(s) of helping the user view data more easily (see: paragraph [0248] of Su et al.).
As per claim 18, McGuan et al., Gargac et al., and Su et al. in combination teaches the method of claim 17, see discussion of claim 17. Su et al. further teaches:
--providing a graphical visualization of the moment arm of one or more muscles selected with the selection mechanism (see: FIG. 32 where there is displaying of a selection mechanism for selecting muscle groups).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 17, and incorporated herein.
As per claim 19, McGuan et al., Gargac et al., and Su et al. in combination teaches the method of claim 17, see discussion of claim 17. Su et al. further teaches:
--providing a graphical visualization of the force-length curve through relevant ranges-of-motion for the one or more muscles selected with the selection mechanism (see: paragraph [0248] where there is providing of a force exertion of the muscles on the display. Also see: paragraph [0099] where there is a strain gauge sensor. Also see: paragraph [0126] where there are force patterns).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 17, and incorporated herein.
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2021/0315642 to McGuan et al. in view of U.S. 2023/0146371 to Gargac et al. as applied to claim 1, and further in view of U.S. 2024/0293182 to Zhang et al.
As per claim 21, McGuan et al. and Gargac et al. in combination teaches the method of claim 20, see discussion of claim 20. The combination may not further, specifically teach:
--providing a comparison between the originally-selected implant model and the one or more additional selected implant models.
Zhang et al. teaches:
--providing a comparison between the originally-selected implant model and the one or more additional selected implant models (see: paragraph [0103] where there is a comparison between implant models).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to provide a comparison between the originally-selected implant model and the one or more additional selected implant models as taught by Zhang et al. in the method as taught by McGuan et al. and Gargac et al. in combination with the motivation(s) of improving the post-operative function of the patient’s joint (see: paragraph [0109] of Zhang et al.).
As per claim 22, McGuan et al., Gargac et al., and Zhang et al. in combination teaches the method of claim 21, see discussion of claim 21. McGuan et al. further teaches:
--providing a graphical visualization of the range-of-motion with respect to each of the three axes of rotation for each of the selected implant models (see: paragraph [0222] and FIG. 12A where there is providing a graphical visualization of the range-of-motion with respect to the axes of motion).
As per claim 23, McGuan et al., Gargac et al., and Zhang et al. in combination teaches the method of claim 22, see discussion of claim 22. Zhang et al. further teaches:
--providing suggestions of one or more implant positions that optimize certain parameters such as muscle moment arm, force-length curve, or minimal impingement (see: paragraph [0119] where there is an implant configuration which maximizes the muscle moment capacity curves).
The motivations to combine the above-mentioned references are discussed in the rejection of claim 21, and incorporated herein.
Conclusion
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684
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