DETAILED ACTION
Notice to Applicant
This communication is in response to the Request for Continued Examination (RCE) submitted June 10, 2026. Claims 1, 15, and 25 are amended. Claims 2 – 4, 6, 10, 12, 14, 18, and 20 were previously cancelled. Claims 1, 5, 7 – 9, 11, 13, 15 – 17, 19, and 21 – 29 are pending.
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 10, 2026 has been entered.
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, 5, 7 – 9, 11, 13, 15 – 17, 19, and 21 – 29 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.
Step One
Claims 1, 5, 7 – 9, 11, 13, 15 – 17, 19, and 21 – 29 are drawn to a system and method, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claims 1 and 15 recite receiving an input related to a position of an implant model relative to a bone model within a surgical planning environment; and preoperatively calculate a deviation between a planned postoperative implant center of rotation of the implant model and a preoperative native anatomy center of rotation of the bone model; wherein the deviation is calculated preoperatively without using any physical implant or interoperative image, wherein the preoperative native anatomy center of rotation is the native center of rotation about which a joint mechanics of a joint associated with the bone model will revolve, wherein the preoperative native anatomy center of rotation is derived from an original, non- deteriorated anatomy of a patient associated with the bone model, wherein the planned postoperative implant center of rotation is a value associated with an implant associated with the implant model.
Independent claim 25 recites providing a preoperative planning input, wherein the preoperative planning input includes a position of an implant model relative to a bone model of a subject patient; receiving an identification of a planned postoperative implant center of rotation of an implant of the implant model relative to the bone model; receiving a delta distance between the planned postoperative implant center of rotation and a preoperative native anatomy center of rotation of a bone of the bone model, wherein the delta distance is calculated preoperatively; adjusting the position of the implant model relative to the bone model until a desired delta distance between the planned postoperative implant center of rotation and the preoperative native anatomy center of rotation is achieved; and performing a surgical procedure on the subject patient according to the surgical plan.
The respective dependent claims 5, 7 – 9, 11, 13, 16 – 17, 19, 21 – 24, and 26 – 29, but for the inclusion of the additional elements specifically addressed below, provide recitations further limiting the invention of the independent claim(s).
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states that the disclosure “relates to improved surgical planning systems and methods” (paragraph 4 of the published specification). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including:
Claim 1: “surgical planning system”, “memory device configured to store computer executable instructions”, “a processor operably coupled to the memory device and configured to execute the computer executable instructions”, “virtual”, “display window”, “graphical user interface”
Claims 5, 19: “surgical planning system”, “virtual”
Claims 7, 16, 21, 28, 29: “surgical planning system”
Claim 8: “surgical planning system”, “processor”, “user interface”
Claims 9, 27: “surgical planning system”, “user interface”
Claim 11: “surgical planning system”, “the processor is further configured to query a database”, “the database is an anatomical makeup classification database that stores a plurality of anatomical makeup classifications”
Claim 13: “surgical planning system”, “the processor is further configured to command that a user be prompted to assess a probability of a successful surgical outcome based on the records having the similar center of rotation characteristics”
Claim 15: “surgical planning system”, “memory device configured to store computer executable instructions”, “a processor operably coupled to the memory device and configured to execute the computer executable instructions to execute a surgical planning environment that includes a display module, a spatial module, and a comparison module”, “computationally derived from a three-dimensional model”, “display window of a graphical user interface”, “virtual”
Claim 17: “surgical planning system”, “display window”
Claims 22 – 24: “surgical planning system”, “processor”, “display window”
Claim 25: “surgical planning system”, “saving a surgical plan that includes the desired delta distance”, “automatically updates”, “display window of the graphical user interface”
Claim 26: “virtually displayed in the graphical user interface”
These features are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, 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.
Hence, the 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. Accordingly, 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, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The published specification supports this conclusion as follows:
[0045] The system 10 may include, among other things, at least one host computer 12, one or more client computers 14, one or more imaging devices 16, a cloud-based storage system 18, and a network 20. The system 10 may include a greater or fewer number of subsystems within the scope of this disclosure.
[0047] The host computer 12 may be operable to communicate with the network 20, which itself may include one or more computing devices. The network 20 may be a private local area network (LAN), a private wide area network (WAN), the Internet, or a mesh network, for example.
[0048] The host computer 12 and each client computer 14 may include one or more of a computer processor, memory, storage means, network devices and input and/or output devices and/or interfaces. The input devices may include a keyboard, mouse, etc. The output devices may include a monitor, speakers, printers, etc. The memory may, for example, include UVPROM, EEPROM, FLASH, RAM, ROM, DVD, CD, a hard drive, or other computer readable medium that may store data and/or other information relating to the surgical planning and implementation techniques disclosed herein. The host computer 12 and each client computer 14 may be a desktop computer, laptop computer, smart phone, tablet, virtual machine, or any other computing device. The interfaces may facilitate communication with the other systems and/or components of the network 20.
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 5, 7 – 9, 11, 13, 16 – 17, 19, 21 – 24, 26 – 29 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 7, 15, 22 – 24, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over de Souza et al., herein after de Souza (U.S. Publication Number 2020/0188026 A1) in view of Amanatullah (U.S. Publication Number 10,806,518 B2) further in view of Willowick et al., herein after Willowick (U.S. Publication Number 2024/0245375 A1).
Claim 1 (Currently Amended). de Souza teaches a surgical planning system (paragraph 2 discloses preoperative planning and postoperative analysis of surgeries), comprising:
a memory device configured to store computer executable instructions (paragraph 67 discloses a memory device communicably coupled to the processor via the processing circuit and includes computer code for executing one or more processes); and
a processor operably coupled to the memory device and configured to execute the computer executable instructions (paragraph 18 discloses a computer program stored on one or more tangible, non-transitory, computer-readable storage media having executable instructions for performing the computer program on a computing system; paragraph 67 discloses a memory device communicably coupled to the processor via the processing circuit and includes computer code for executing one or more processes) to:
receive an input related to a position of a virtual implant model relative to a virtual bone model within a surgical planning environment (paragraph 70 discloses scan data is segmented to obtain 3D representation of the anatomy and the computer is programmed to calculate the implantation of the implants indicating receiving an input related to the position of an implant relative to a bone model; paragraph 76 discloses after surgical planning and prior to performing an arthroplasty procedure, the physical anatomy (e.g. bones) is registered to a virtual representation of the anatomy ( e.g. a preoperative three-dimensional representation) using any known registration technique);
wherein the preoperative native anatomy center of rotation is the native center of rotation about which a joint mechanics of a joint associated with the virtual bone model will revolve (paragraph 70 discloses based on the patient's current femoral-tibial alignment and the desired femoral-tibial alignment to be achieved by the arthroplasty procedure and further including the size, model and placement of the proposed femoral and tibial implants (including the desired extension, varus-valgus angle, and internal-external rotation associated with the implantation of the proposed implants) the computer is programmed to calculate the desired implantation of the proposed implants or at least assist in the preoperative planning of the implantation of the proposed implants);
wherein the preoperative native anatomy center of rotation is derived from an original, non-deteriorated anatomy of a patient associated with the virtual bone model (paragraph 159 discloses reconstructing the original bone in the post-operative medical images, for example, a statistical model trained on preoperative bones may be fitted to the remining postoperative bone to provide an estimate or reconstruction of the regions removed).
de Souza fails to explicitly teach the following limitations met by Amanatullah as cited:
preoperatively calculate a deviation between a planned postoperative implant center of rotation of the virtual implant model and a preoperative native anatomy center of rotation of the virtual bone model (column 4, line 60 through column 5, line 11 discloses the computer system can transition to: handling the virtual patient model as "ground truth" for the patient; and registering the virtual patient model to the patient based on the constellation of intermediate features. the computer system can implement the virtual patient model as the virtual "ground truth" representation of the patient's anatomy … such that this ground truth representation of the patient defines a preoperative anatomical state the patient regardless of changes made to the patient's anatomy during the surgery, thereby enabling the surgeon: to "look back" to quantify actual changes in the patient's anatomy during the surgery; and to "look forward" to planned future changes to the patient's anatomy during the surgery based on this virtual ground truth representation of the patient's anatomy; column 17, lines 6 – 29 discloses the computer system can derive a joint center of rotation of the patient's left hip relative to the patient's lower torso, indicating the center of rotation; column 3, lines 17 – 24 discloses calculating a spatial difference between the actual resected contour of the hard tissue of interest detected in the first sequence of optical scans and the target resected contour of the hard tissue of interest represented in the virtual patient model registered to the hard tissue of interest in the surgical and presenting the spatial difference to a surgeon during the surgical operation); and
display the deviation, the planned postoperative implant center of rotation, and the preoperative native anatomy center of rotation within a display window of a graphical user interface of the surgical planning environment (column 30, lines 62 – 65 discloses The computer system can then render this spatial difference on a display near the surgical field or serve an augmented reality indicating this spatial difference to the surgeon's augmented reality headset, wherein the deviation is calculated preoperatively without using any physical implant or interoperative image).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of de Souza to further include methods for augmenting a surgical field with virtual guidance and tracking and adapting to deviation from a surgical plan as disclosed by Amanatullah.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of de Souza in this way by accessing a virtual patient model defining a target position of an artificial implant on a hard tissue of interest (Amanatullah: column 3, lines 25 – 28).
de Souza and Amanatullah fail to explicitly teach the following limitations met by Willowick as cited:
wherein the planned postoperative implant center of rotation is a value associated with a virtual implant associated with the virtual implant model (paragraph 78 discloses an intraoperative image is also referred to as a “postop image” or an “intraop” image; paragraph 87 discloses the landmark identification module identifies the approximate femoral center of rotation in the intraop image; claim 1 discloses predicting a post-operative leg length differential (value); claim 3 discloses selecting a final prosthesis to be implanted based on the predicted post-operative leg length differential).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of de Souza and Amanatullah to further include systems and methods for intra-operative image analysis to quantify restoration or orthopedic functionality at a surgical site within a patient, even during a surgical procedure as disclosed by Wollowick.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of de Souza and Amanatullah in this way to provide a non-invasive system and method providing intraoperative guidance and data by correcting for deviations in femoral positioning between preoperative and intraoperative images (Wollowick: paragraph 8).
Claim 7 (Original). de Souza, Amanatullah, and Wollowick teach the surgical planning system as recited in claim 1. de Souza teaches a system wherein the deviation is a delta distance representing a length of a vector in a three dimensional space between the planned postoperative implant center of rotation and the preoperative native anatomy center of rotation (paragraph 160 discloses comparing the position and orientation of the implant as executed versus as planned, where the differences may be expressed as a measurement of distance and rotation).
Claim 22 (Previously Presented). de Souza, Amanatullah, and Wollowick teach the surgical planning system as recited in claim 1.
de Souza and Amanatullah fail to explicitly teach the following limitations met by Willowick as cited:
wherein the processor is further configured to cause a first indicator representing the preoperative native anatomy center of rotation and a second indicator representing the planned postoperative implant center of rotation to be displayed within a first display window of a user interface of the surgical planning environment (paragraph 97 discloses the image comparison module superimposes the preop and intraop images by aligning pelvic anatomy, with the images displayed, so both can be visualized).
The motivation to combine the teachings of de Souza, Amanatullah, and Wollowick is discussed in the rejection of claim 1, and incorporated herein.
Claim 23 (Previously Presented). de Souza, Amanatullah, and Wollowick teach the surgical planning system as recited in claim 22.
de Souza and Amanatullah fail to explicitly teach the following limitations met by Willowick as cited:
wherein the processor is further configured to cause the first indicator to be displayed within a second display window of the user interface (Figure 23; paragraph 112 discloses a preop image along with an intraop image on the screen, which correlates to figure 3 and paragraph 71 of Applicant’s published specification (“the user interface 56 may include one or more display windows 60 and one or more objects 62 that may be presented within the display windows 60. The display windows may include any number of windows, and the objects may include any number of objects”)).
The motivation to combine the teachings of de Souza, Amanatullah, and Wollowick is discussed in the rejection of claim 1, and incorporated herein.
Claim 24 (Previously Presented). de Souza, Amanatullah, and Wollowick teach the surgical planning system as recited in claim 22.
de Souza and Amanatullah fail to explicitly teach the following limitations met by Willowick as cited:
wherein the processor is further configured to cause coordinates associated with either the preoperative native anatomy center of rotation or the planned postoperative implant center of rotation to be displayed within a graphic indicator that overlays or is arranged adjacent to the first display window (Figures 22 and 23; paragraph 109 discloses preop and intraop images are compared using X-Y coordinate system).
The motivation to combine the teachings of de Souza, Amanatullah, and Wollowick is discussed in the rejection of claim 1, and incorporated herein.
Claim 29 (Previously Presented). de Souza, Amanatullah, and Wollowick teach the surgical planning system as recited in claim 1. de Souza teaches a system wherein the deviation is a pre- operatively calculated delta distance that extends from the planned postoperative implant center of rotation to the preoperative native anatomy center of rotation (Figures 12A – 12C disclose an axial, a sagittal, and a coronal view of the preoperative images of the knee joint overlaid with the segmented cross-section line of the 3D implant model).
System claim 15 repeats the subject matter of claim 1. As the underlying processes of claim 15 has been shown to be fully disclosed by the teachings of de Souza, Amanatullah, and Wollowick in the above rejections of claim 1; as such, these limitations (claim 15) are rejected for the same reasons given above for claim 1 and incorporated herein.
Claim(s) 5, 8 – 9, 11, 13, 16 – 17, 19, 21, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over de Souza et al., herein after de Souza (U.S. Publication Number 2020/0188026 A1) in view of Amanatullah (U.S. Publication Number 10,806,518 B2) further in view of Wollowick (U.S. Patent Number 12,109,120 B2) and Morvan et al., herein after Morvan (U.S. Publication Number 2021/0093385 A1).
Claim 5 (Previously Presented). de Souza, Amanatullah, and Wollowick teach the surgical planning system as recited in claim 1.
de Souza, Amanatullah, and Wollowick fail to explicitly teach the following limitations met by Morvan as cited:
wherein the virtual implant is a glenosphere implant or a humeral head implant (Figure 10; paragraph 188 discloses a 3D virtual bone model of the anatomy of interest, such as a glenoid bone or a humeral bone; paragraph 421 discloses a glenoid base plate and glenosphere for reverse arthroplasty).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of de Souza and Wollowick to further include visualization of intraoperatively modified surgical plans using techniques for preoperative surgical planning, intra-operative surgical planning, intra-operative surgical guidance, intra-operative surgical tracking, and post-operative analysis using mixed reality (MR) based visualization as disclosed by Morvan.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of de Souza and Wollowick in this way to assist surgeons with the design and/or selection of surgical guides and implants that closely match the patient’s anatomy and can improve surgical outcomes by customizing a surgical plan for each patient (Morvan: paragraph 3).
Claim 8 (Original). de Souza, Amanatullah, and Wollowick teach the surgical planning system as recited in claim 7.
de Souza, Amanatullah, and Wollowick fail to explicitly teach the following limitations met by Morvan as cited:
wherein the processor is further configured to cause the delta distance to be displayed within a user interface of the surgical planning environment (Figure 20A; paragraph 275 discloses as part of the initialization procedure, the MR (Mixed Reality) system determines the distance between visualization device and a point (or points) on the surface of the observed bone in the field of view of visualization device and the orientation of that surface using sensor data collected from the depth, optical, and motion sensors; paragraph 276 discloses distance information can be derived by MR system and can be used to derive the geometric shape of the surface of an observed bone).
The motivation to combine the teachings of de Souza, Amanatullah, Wollowick, and Morvan is discussed in the rejection of claim 5, and incorporated herein.
Claim 9 (Previously Presented). de Souza, Amanatullah, Wollowick, and Morvan teach the surgical planning system as recited in claim 8. de Souza discloses a system wherein the delta distance is visually indicated by a line extending between the planned postoperative implant center of rotation and the preoperative native anatomy center of rotation (Figures 12A – 12C disclose an axial, a sagittal, and a coronal view of the preoperative images of the knee joint overlaid with the segmented cross-section line of the 3D implant model).
de Souza, Amanatullah, and Wollowick fail to explicitly teach the following limitations met by Morvan as cited:
or by a numerical value in a graphic indicator value of the user interface (paragraph 310 discloses the MR (Mixed Reality) system may output a representation of the confidence distance. As one example, MR system may cause visualization device to display a numerical value of the confidence distance).
The motivation to combine the teachings of de Souza, Amanatullah, Wollowick, and Morvan is discussed in the rejection of claim 5, and incorporated herein.
Claim 11 (Previously Presented). de Souza, Amanatullah, and Wollowick teach the surgical planning system as recited in claim 1.
de Souza, Amanatullah, and Wollowick fail to explicitly teach the following limitations met by Morvan as cited:
wherein the processor is further configured to query a database of the surgical planning system for records having similar center of rotation characteristics (paragraph 751 discloses an MR may maintain a database of information associated with prior patients or prior surgeries, which may be able to identify situations or circumstances to impart knowledge germane to a current surgery or procedure, indicating similar characteristics), and
the database is an anatomical makeup classification database that stores a plurality of anatomical makeup classifications that characterize anatomical differences and variances within the anatomical differences within a representative patient population (paragraph 742 discloses MR visualization devices may allow surgeons to view 3D content and visualize exactly what will happen, step-by-step, during a procedure, the information provided to the physician may comprise general patient information based on information from the general patient population or may be patient-specific information associated with the specific patient on which a given procedure will be performed; paragraph 821 discloses each output element in the plurality of output elements corresponds to a different classification in one or more shoulder pathology classification systems, a computing system may generate a plurality of training datasets from past shoulder surgery cases and each respective training dataset corresponds to a different training data patient in a plurality of training data patients and comprises a respective training input vector and a respective target output vector).
The motivation to combine the teachings of de Souza, Amanatullah, Wollowick, and Morvan is discussed in the rejection of claim 5, and incorporated herein.
Claim 13 (Previously Presented). de Souza, Amanatullah, Wollowick, and Morvan teach the surgical planning system as recited in claim 11.
de Souza, Amanatullah, and Wollowick fail to explicitly teach the following limitations met by Morvan as cited:
wherein each of the plurality of anatomical makeup classifications is a numerical classification of an anatomical makeup of a bone or a joint of the representative patient population (paragraph 831 discloses the computing system may determine the classification of the shoulder condition of the patient based on a comparison of the values of the output elements generated by the NN, the values of the output element may correspond to confidence values that indicate levels of confidence that the patient’s should condition belongs in the classes that correspond to the output), and
wherein the processor is further configured to command that a user be prompted to assess a probability of a successful surgical outcome based on the records having the similar center of rotation characteristics (paragraph 831 discloses the computing system may determine the classification of the shoulder condition of the patient based on a comparison of the values of the output elements generated by the NN, the values of the output element may correspond to confidence values that indicate levels of confidence that the patient’s should condition belongs in the classes that correspond to the output, where the confidence level is interpreted as the likelihood of a successful outcome).
The motivation to combine the teachings of de Souza, Amanatullah, Wollowick, and Morvan is discussed in the rejection of claim 5, and incorporated herein.
Claim 21 (Previously Presented). de Souza, Amanatullah, Wollowick, and Morvan teach the surgical planning system as recited in claim 13.
de Souza, Amanatullah, and Wollowick fail to explicitly teach the following limitations met by Morvan as cited:
wherein each of the plurality of anatomical makeup classifications is a unique, multi-character identifier for describing the anatomical makeup of the bone or the joint, and further wherein each character of the unique, multi-character identifier is a unitless character (Fig 9 discloses a unique, multi-character identifier to select a patient’s surgical plan; paragraph 228 discloses a welcome page displaying a menu to select a specific patient’s surgical plan; paragraph 579 discloses MR system may perform visual object detection as a verification to ensure the correct surgical item is being used, where the visual object detection may refer to detection of object shape (or possibly detection of bar code, text, letter, numbers, words, or other identifying indicia associated with a surgical item)).
The motivation to combine the teachings of de Souza, Amanatullah, Wollowick, and Morvan is discussed in the rejection of claim 5, and incorporated herein.
Claim 27 (Previously Presented). de Souza, Amanatullah, Wollowick, and Morvan teach the surgical planning system as recited in claim 9.
de Souza, Amanatullah, and Wollowick fail to explicitly teach the following limitations met by Morvan as cited:
wherein the numerical value includes a unit of measurement that is displayed within the graphic indicator of the user interface (paragraph 310 discloses the MR system may output a representation of the confidence distance by displaying a numerical value of the distance).
The motivation to combine the teachings of de Souza, Amanatullah, Wollowick, and Morvan is discussed in the rejection of claim 5, and incorporated herein.
Claim(s) 25 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over de Souza et al., herein after de Souza (U.S. Publication Number 2020/0188026 A1) in view of Wollowick (U.S. Patent Number 12,109,120 B2) and Morvan et al., herein after Morvan (U.S. Publication Number 2021/0093385 A1) further in view of Behzadi (U.S. Publication Number 2021/0186454 A1).
Claim 25 (Currently Amended). de Souza teaches a surgical method, comprising:
providing a preoperative planning input to a surgical planning system (paragraph 2 discloses preoperative planning and postoperative analysis of surgeries),
wherein the preoperative planning input includes a position of a virtual implant model relative to a virtual bone model of a subject patient (paragraph 70 discloses scan data is segmented to obtain 3D representation of the anatomy and the computer is programmed to calculate the implantation of the implants indicating receiving an input related to the position of an implant relative to a bone model);
receiving, from the surgical planning system, an identification of a planned postoperative implant center of rotation of a virtual implant of the virtual implant model relative to the virtual bone model (paragraph 132 discloses the comparison step may indicate a positional and angular difference between a planned drill hole or resection plane associated with the preoperative 3D bone model and an implant post location on the implant model; paragraph 133 discloses the comparison step may indicate the difference between the planned bone modifications and the actual bone modifications, as well as the differences between the planned implant placement and the actual implant placement, indicating center of rotation of both implant and bone models);
receiving, from the surgical planning system, a delta distance between the planned postoperative implant center of rotation and a preoperative native anatomy center of rotation of a virtual bone of the virtual bone model (paragraph 160 discloses comparing the position and orientation of the implant as executed versus as planned, where the differences may be expressed as a measurement of distance and rotation),
saving a surgical plan that includes the desired delta distance (paragraph 160 discloses pulling the preoperative plan containing specific information from a storage location; paragraph 161 discloses outcome scores and functional measures may be stored in the database for each patient including the preoperative surgical plan, and postoperative assessment of the implant positioning); and
performing a surgical procedure on the subject patient according to the surgical plan (paragraph 83 discloses once the surgical plan has been finalized, a surgeon may perform the arthroplasty procedure).
de Souza fails to explicitly teach the following limitations met by Wollowick as cited:
adjusting the position of the virtual implant model relative to the virtual bone model until a desired delta distance between the planned postoperative implant center of rotation and the preoperative native anatomy center of rotation is achieved (paragraph 15 discloses the analysis module calculates length differential by estimating distance from the reference landmark point to the corrected intraoperative landmark point, and calculates offset by estimating distance from the reference landmark point to the corrected intraoperative landmark; paragraph 78 discloses “scaled images that are overlaid and aligned according to the stationary anatomic region (such as the pelvis), the generation of at least one landmark point on the nonstationary, articulating anatomic region (such as the femur) in both images, a mechanism to identify the difference in femoral angle of the femur relative to the pelvis between the images, a mathematical correction module that adjusts for differences in the articulating femur in each image relative to the stationary pelvis and, finally, a calculation module that uses this input to calculate intraoperative changes in offset and leg length”),
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of de Souza to further include systems and methods for intra-operative image analysis to quantify restoration or orthopedic functionality at a surgical site within a patient, even during a surgical procedure as disclosed by Wollowick.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of de Souza in this way to provide a non-invasive system and method providing intraoperative guidance and data by correcting for deviations in femoral positioning between preoperative and intraoperative images (Wollowick: paragraph 8).
de Souza and Wollowick fail to explicitly teach the following limitations met by Morvan as cited:
wherein the delta distance is virtually displayed within a graphical user interface of the surgical planning system (Figure 20A; paragraph 275 discloses as part of the initialization procedure, the MR (Mixed Reality) system determines the distance between visualization device and a point (or points) on the surface of the observed bone in the field of view of visualization device and the orientation of that surface using sensor data collected from the depth, optical, and motion sensors; paragraph 276 discloses distance information can be derived by MR system and can be used to derive the geometric shape of the surface of an observed bone).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of de Souza and Wollowick to further include visualization of intraoperatively modified surgical plans using techniques for preoperative surgical planning, intra-operative surgical planning, intra-operative surgical guidance, intra-operative surgical tracking, and post-operative analysis using mixed reality (MR) based visualization as disclosed by Morvan.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of de Souza and Wollowick in this way to assist surgeons with the design and/or selection of surgical guides and implants that closely match the patient’s anatomy and can improve surgical outcomes by customizing a surgical plan for each patient (Morvan: paragraph 3).
de Souza, Wollowick, and Morvan fail to explicitly teach the following limitations met by Behzadi as cited:
wherein the surgical planning system automatically updates the delta distance in a display window of the graphical user interface in response to each iterative adjustment of the virtual implant model relative to the virtual bone model (paragraph 707 discloses the delta (A) difference between preoperative and postoperative leg lengths (and offset) when the implants are installed; paragraph 715 discloses a set of tags, each tag having an active/passive device (e.g. a sensor) incorporated within a body and applied to pelvis (P) and femur (F) to provide real time or near real time evaluation of leg length (e.g. delta/distance on Y-axis) and offset changes (e.g. delta/distance on X-axis) during THR (total hip replacement)).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of de Souza, Wollowick, and Morvan to further include in situ sensing or monitoring of tissue structures, implants into such structures, and surgical procedures and devices associated with preparation and operation on such structures, as well as relating generally to orthopedic surgical systems and procedures employing a prosthetic implant for, and more specifically, but not exclusively, to joint replacement therapies such as total hip replacement as disclosed by Behzadi.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of de Souza, Wollowick, and Morvan in this way to provide force measurement systems such as may be used in these systems and methods which may evaluate a quality of installation, and generally to assessing a quality of an installation of an implant structure installed in a body, and more specifically, but not exclusively, to quantitative assessment of prosthesis press-fit fixation into a bone cavity, for example, assessment of press-fit fixation of an acetabular cup into a prepared bone cavity, assessment of connective tissue installation and repair (Behzadi: paragraph 2).
Claim 26 (Previously Presented). de Souza, Wollowick, Morvan, and Behzadi teach the surgical method as recited in claim 25. de Souza discloses a method wherein the delta distance is virtually displayed in the graphical user interface in a form of a line that is drawn between the planned postoperative implant center of rotation and the preoperative native anatomy center of rotation (Figures 12A – 12C disclose an axial, a sagittal, and a coronal view of the preoperative images of the knee joint overlaid with the segmented cross-section line of the 3D implant model) or in the form of a numerical value that includes a unit of measurement that is displayed within a graphic indicator of the graphical user interface.
Response to Arguments
Applicant's arguments filed June 10, 2026 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were presented.
Claim Rejections - 35 USC § 101
The Applicant argues the claimed limitations do not recite a judicial exception, and the claims are not directed to methods of organizing human activity. The Examiner disagrees. Under its broadest reasonable interpretation, the Applicant’s claims are an abstract idea that falls into the grouping of “Certain Methods of Organizing Human Activity” which covers fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people. The Examiner respectfully submits that the MPEP 2106.04(a)(2) recites that “Certain Methods of Organizing Human Activity” include managing personal behavior or relationships or interactions between people, including social activities, teaching, and following rules or instructions. The present claims recite the abstract idea of surgical planning of an orthopedic procedure by assessing both an anatomical and an implant model center of rotation. The present claims recite receiving an input related to a position of an implant model relative to a bone model within a surgical planning environment; and calculate a deviation between a planned postoperative implant center of rotation of the implant model and a preoperative native anatomy center of rotation of the bone model; wherein the preoperative native anatomy center of rotation is the native center of rotation about which a joint mechanics of a joint associated with the bone model will revolve, wherein the preoperative native anatomy center of rotation is derived from an original, non- deteriorated anatomy of a patient associated with the bone model, wherein the planned postoperative implant center of rotation is a value associated with an implant associated with the implant model. The present specification recites “One or more surgeons and/or other staff users may be presented with the planning environment 28 via the client computers 14 and may simultaneously access each image 26, bone model 30, implant model 32, transfer model 34, and surgical plan 36 stored in the database(s) 38. Each user may interact with the planning environment 28 to create, view, refine, and/or modify various aspects of the surgical plan 36.” (paragraph 62) indicating personal behavior or relationships or interactions between people. In addition, “…. the system 10 may receive approval of the preoperative surgical plan from the user.” (paragraph 120) indicating organizing the surgical procedure of a patient. These features describe interactions with people, thus “Certain Methods of Organizing Human Activity”. Thus, if a claim limitation, under its broadest reasonable interpretation, covers interactions with people, but for the recitation of generic components, then it is still in the “Certain Methods of Organizing Human Activity” grouping.
The Applicant argues the claims are integrated into a practical application. The Examiner respectfully disagrees. The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. For example, the 2019 PEG guidelines recite limitations that are indicative of integration into a practical application when recited in a claim with a judicial exception include:
Improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP 2106.05(e) and the Vanda Memo issued in June 2018.
The present claims fail to demonstrate an improvement to the functioning of a computer or to any other technology or technical field. Thus, Applicant’s argument is not persuasive, and the rejection is maintained.
The Applicant argues the claims recite significantly more, citing Berkheimer. The Examiner respectfully disagrees. The Berkheimer memo discloses “a citation to an express statement in the specification or to a statement made by applicant during prosecution that demonstrates the well-understood, routine, conventional nature of additional elements.” The Examiner submits the Applicant’s own published specification supports this conclusion and recites:
[0045] The system 10 may include, among other things, at least one host computer 12, one or more client computers 14, one or more imaging devices 16, a cloud-based storage system 18, and a network 20. The system 10 may include a greater or fewer number of subsystems within the scope of this disclosure.
[0047] The host computer 12 may be operable to communicate with the network 20, which itself may include one or more computing devices. The network 20 may be a private local area network (LAN), a private wide area network (WAN), the Internet, or a mesh network, for example.
[0048] The host computer 12 and each client computer 14 may include one or more of a computer processor, memory, storage means, network devices and input and/or output devices and/or interfaces. The input devices may include a keyboard, mouse, etc. The output devices may include a monitor, speakers, printers, etc. The memory may, for example, include UVPROM, EEPROM, FLASH, RAM, ROM, DVD, CD, a hard drive, or other computer readable medium that may store data and/or other information relating to the surgical planning and implementation techniques disclosed herein. The host computer 12 and each client computer 14 may be a desktop computer, laptop computer, smart phone, tablet, virtual machine, or any other computing device. The interfaces may facilitate communication with the other systems and/or components of the network 20.
The Examiner submits the Berkheimer memo requires factual support on the record, which is shown in the 101 rejection above, as well as in the response to the Applicant’s 101 argument. The Applicant’s published specification supports the elements in the claims are “well-understood, routine, and conventional”. The Berkheimer memo recites “In a step 2B analysis, an additional element (or combination of elements) is not well-understood, routine or conventional unless the examiner finds, and expressly supports a rejection in writing with, one or more of the following: 1. A citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates the well-understood, routine, conventional nature of the additional element(s). A specification demonstrates the well-understood, routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a). A finding that an element is well-understood, routine, or conventional cannot be based only on the fact that the specification is silent with respect to describing such element.” The Examiner has cited multiple paragraphs in the Applicant’s published specification (see above) which are directed to well-understood, routine or conventional elements. Thus, Applicant’s argument is not persuasive, and the rejection is maintained.
Claim Rejections - 35 USC § 103
The Examiner submits after further search and consideration, new prior art has been cited for the present claims and the withdrawal of the 103 rejections in the Office Action mailed February 11, 2026 is vacated.
Conclusion
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KRISTINE K. RAPILLO
Examiner
Art Unit 3626
/KRISTINE K RAPILLO/Examiner, Art Unit 3682
