DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This communication is in response to the amendment received on 05/01/2026. Claims 13-24 have been canceled and claims 25-37 have been newly added. Therefore, claims 25-37 remain pending in this application.
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 25-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 25-26 are drawn to a method which is within the four statutory categories (i.e. process). Claims 27-37 are drawn to a system which is within the four statutory categories (i.e. machine).
Step 2A, Prong 1:
Newly added claims 25-37 are provided below with markings separating abstract elements from the additional limitations, wherein the bolded style represents the additional limitations beyond abstract idea, and remaining limitations are directed to the abstract idea as discussed below:
Claim 25: A method of treating a patient through insertion of an implant system into the patient, the method comprising:
collecting patient-specific data including demographic information and a patient requirement profile;
performing a patient mobility analysis to collect patient-specific pre-surgery kinematic data;
enriching the patient-specific pre-surgery kinematic data with comparative postoperative kinematic data to generate enriched patient-specific kinematic data, the comparative postoperative kinematic data comprising historical data similar to the patient-specific pre-surgery kinematic data based on older or earlier insertions of the implant system;
collecting data about the implant system including an implant type, implant orientation, and implant size;
performing planning regarding implant selection and positioning based on the enriched patient-specific kinematic data and data collected about the implant system;
performing a simulation to test the planning of insertion of the implant system with regard to mechanical limits of the implant system, taking into account the enriched patient-specific kinematic data and the data collected about the implant system;
performing one of approving the planning when the mechanical limits of the implant system have not been exceeded during the simulation, or suggesting a plan modification to comply with the mechanical limits of the implant system;
inserting the implant system into the patient using planning and simulation data collected during the planning and simulation steps;
collecting interoperative kinematics and soft tissue data about intraoperative changes of the implant system to update planning during insertion of the implant system;
performing postoperative kinematics therapy including movement analysis using the enriched patient-specific kinematic data and intraoperative data collected about the intraoperative changes of the implant system; and
collecting postoperative kinematics data during the postoperative kinematics therapy as the comparative postoperative kinematic data.
Claim 26: The method of claim 25, further comprising determining a phenotype of the patient based on the enriched patient-specific kinematic data.
Claim 27: A system for implementing an integrated therapy chain for planning and carrying out insertion of an implant system, the integrated therapy chain having a preoperative therapy step, an intraoperative therapy step, and a postoperative therapy step, the system comprising:
a first data device that collects patient-specific pre-surgery kinematic data during a patient mobility analysis;
a second data device that collects patient-specific data including demographic information and a patient requirement profile;
a third data device that collects data about the implant system including an implant type, implant orientation, and implant size; and
a control unit for controlling the first data device, the second data device and the third data device, and for performing the preoperative therapy step, the intraoperative therapy step and the postoperative therapy step based on the patient-specific pre-surgery kinematic data, the patient- specific data, and the data about the implant system, the control unit performing operations including:
performing the preoperative therapy step, the preoperative therapy step comprising:
enriching the patient-specific pre-surgery kinematic data with comparative postoperative kinematic data to generate enriched patient-specific kinematic data, the comparative postoperative kinematic data comprising historical data similar to the patient- specific pre-surgery kinematic data based on older or earlier insertions of the implant system;
performing planning regarding implant selection and positioning based on the enriched patient-specific kinematic data and data collected about the implant system;
performing a simulation to test the planning of insertion of the implant system with regard to mechanical limits of the implant system, taking into account the enriched patient- specific kinematic data and the data collected about the implant system; and
performing one of approving the planning when the mechanical limits of the implant system have not been exceeded during the simulation, or suggesting a plan modification to comply with the mechanical limits of the implant system;
performing the intraoperative therapy step, the intraoperative therapy step comprising collecting interoperative kinematics and soft tissue data about intraoperative changes of the implant system to update planning during insertion of the implant system into a patient using the planning and simulation data collected during the planning and simulation steps; and
performing the postoperative therapy step, the postoperative therapy step comprising:
collecting postoperative kinematics data during postoperative kinematics therapy including movement analysis using the enriched patient-specific kinematic data and intraoperative data collected about the intraoperative changes of the implant system; and
providing the collected postoperative kinematics data as the comparative postoperative kinematic data.
Claim 28: The system according to claim 27, wherein the preoperative therapy step further comprises choosing an optimal time for surgery.
Claim 29: The system according to claim 27, wherein the preoperative therapy step includes detecting and processing the patient-specific pre-surgery kinematic data in the first data device and detecting and processing the patient-specific data in the second data device.
Claim 30: The system according to claim 29, wherein the first data device is configured to determine kinematics and a phenotype from the enriched patient-specific kinematic data.
Claim 31: The system according to claim 27, further comprising a fourth data device for storing, processing, and providing image material.
Claim 32: The system according to claim 31, wherein the preoperative therapy step further includes detecting the image material and processing the image material in the fourth data device.
Claim 33: The system according to claim 32, wherein the fourth data device is configured to determine a bone morphology based on the image material.
Claim 34: The system according to claim 33, wherein the preoperative therapy step further includes testing mechanical limits of the implant system based on the planning of the insertion of the implant system, the bone morphology, and an implant orientation.
Claim 35: The system according to claim 27, wherein the preoperative therapy step further includes determining at least an implant type and an implant size based on processed data of at least one of the first data device and the second data device, and the data collected by the third data device.
Claim 36: The system according to claim 27, further comprising a navigation or robotic system, wherein the intraoperative therapy step further comprises implementing the planning of the insertion of the implant system, based on the simulation of the insertion of the implant system, using the navigation or robotic system.
Claim 37: The system according to claim 27, wherein the postoperative therapy step further includes adapting movement analysis during patient rehabilitation based on the enriched patient-specific kinematic data and a preoperative requirement profile.
Claims 25and 27 are specifically directed to the abstract idea (see the limitations not bolded style above) of “certain methods of organizing human activities” based on managing personal behavior and interactions between people regarding planning implant selection, approving the planning or suggesting a plan modification and performing postoperative therapy (i.e. rehabilitation) for the patient.
After considering all claim elements, both individually and in combination and in ordered combination, it has been determined that the claims do not amount to significantly more than the abstract idea itself.
Claims 26 and 28-37 are ultimately dependent from claims 25, 27 and include all the limitations of claims 25, 27. Therefore, claims 26 and 28-37 recite the same abstract idea. Claims 26 and 28-37 describe a further limitation regarding the basis for planning and determining implant selection. These are all just further describing the abstract idea recited in claims 25, 27, without adding significantly more.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claims recite the additional elements that are shown in bolded style above, which are hardware or software elements, these limitations are not enough to qualify as “practical application” being recited in the claims along with the abstract idea since these elements are merely invoked as a tool to apply instructions of the abstract idea in a particular technological environment, and mere instructions to apply/implement/automate an abstract idea in a particular technological environment and merely limiting the use of an abstract idea to a particular field or technological environment do not provide practical application for an abstract idea (MPEP 2106.05(f) & (h)).
In particular, the claims and the specification recite the first, second, third devices for collecting data and the electronic system including the control unit to perform preoperative, intraoperative and postoperative therapy steps. The control unit compares the collected data with the comparable cases data to provide planning, that corresponds to mere instructions to apply/implement/automate an abstract idea, using generic computing devices. The current specification recites “The electronic system (device) according to the disclosure has a first data device for detecting, processing and providing patient-specific kinematic data, a second data device for detecting, processing and providing patient data, preferably a fourth data device for storing, processing and providing image material, a third data device for storing and providing data of the specific implant system/ implant system selected from a number of implant systems, and a control unit for controlling the data devices and for performing the therapy steps based on the above data, wherein the first data device (2) is provided and configured to provide at least a first and a second data set, wherein the first data set comprises the currently detected patient-specific kinematic data, the second data set comprises historical data similar to the currently detected patient- specific kinematic data based on older insertions of the specific/selectable implant system, and the second data set is configured and provided to supplement the first data set with empirical values from the historical data.” on page 3, lines 6-17.
The recitation of “performing a simulation to teat the planning of insertion of the implant system…”-claims 1, 27 and “…a navigation or robotic system, wherein the intraoperative therapy step further comprises implementing the planning of the insertion of the implant system, based on the simulation of the insertion of the implant system, using the navigation or robotic system”-claim 36 corresponds to a well-understood, routine and conventional activity, as evidenced by the applied prior art, Miles (US 8,983,813 B2). In particular, Miles teaches “…the alignment information data is transferred to the alignment system indirectly in the form of a robotics file (not shown) comprising the alignment information data as instructions for controlling the alignment system to perform the alignment of the orthopaedic implant for the joint…” in col. 45, lines 4-9.
Claims recite “inserting the implant system into the patient using planning and simulation data collected during the planning and simulation steps”, and this feature corresponds to “insignificant application” (see MPEP 2106.05(g)).
Claims also recite collecting data (pre-surgery, demographics, interoperative and postoperative data) using data devices, which are well-understood, routine and conventional activities (see MPEP 2106.05 (d)), which do not provide significantly more to an abstract idea.
Claims recite the feature of “performing post-operative kinematics therapy including movement analysis…” and the specification recites “…the postoperative therapy step comprises rehabilitation” on page 4, line 30. The feature of “the movement analysis” or “the intelligent mobility analysis” is describes in the current specification as gait analysis, which is observing and quantifying body movements, mechanics, and muscle activity to identify abnormalities or inefficiencies in walking or running, that corresponds to an abstract idea.
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 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 element of using generic system including devices and control unit to perform both the planning and determining steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The claims are not patent eligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 25-37 are rejected under 35 U.S.C. 103 as being unpatentable over Miles et al. (hereinafter Miles) (US 8,983,813 B2) in view of Daley et al. (hereinafter Daley) (US 11,158,415 B2).
Newly added claim 25 recites a method of treating a patient through insertion of an implant system into the patient, the method comprising:
collecting patient-specific data including demographic information and a patient requirement profile (Miller discloses “…receive, via the data interface, patient specific data for deriving patient data, the patient specific information being indicative of one or more dynamic characteristics;…” in col. 23, lines 30-33);
performing a patient mobility analysis to collect patient-specific pre-surgery kinematic data (Miller discloses “…the one or more dynamic characteristics comprises a virtual prediction based on one or more of joint kinematics data; joint loading data;…” in col. 23, lines 60-62);
enriching the patient-specific pre-surgery kinematic data with comparative postoperative kinematic data to generate enriched patient-specific kinematic data, the comparative postoperative kinematic data comprising historical data similar to the patient-specific pre-surgery kinematic data based on older or earlier insertions of the implant system (Miles discloses “FIG. 3 shows a computer-implemented method 300 for providing alignment information data for the alignment of an orthopaedic implant for a joint of a patient in accordance with an embodiment of the present invention. The computer implemented method 300 is suited for implementation on one or more computing devices 100 and in particular one or more computing devices 100 communicating across a network 200, as substantially shown in FIG. 2. Specifically, Such a computing device 100 comprises a processor 1000 for processing digital data,…” in col. 38, lines 13-22, “The library data also includes library alignment configuration data relating to a group of available orthopaedic implants for performing post-implant activities and library alignment configuration data relating to a group of patients fitted with an orthopaedic implant for performing post-implant activities. The orthopaedic implants may be commercially available orthopaedic implants, or orthopaedic implants that have been customised specifically for previous patients.” in col. 38, lines 48-56);
collecting data about the implant system including an implant type, implant orientation, and implant size (Miles; col. 53, lines 1-27: implant design according to patient library data and the implant range data);
performing planning regarding implant selection and positioning based on the enriched patient-specific kinematic data and data collected about the implant system (Miles; col. 53, lines 1-27: implant design according to patient library data and the implant range data);
performing a simulation to test the planning of insertion of the implant system with regard to mechanical limits of the implant system, taking into account the enriched patient-specific kinematic data and the data collected about the implant system (Miles discloses “A deterministic patient specific rigid body mechanics simulation is performed by the computing device 100, A deterministic model is developed when a simulation is performed on a specific implant position to produce a simulated result.” In col. 54, lines 61-65);
performing one of approving the planning when the mechanical limits of the implant system have not been exceeded during the simulation, or suggesting a plan modification to comply with the mechanical limits of the implant system (Miles discloses “The operator can view the simulation result of the default position with chosen orthopaedic implants in the form of for example, a graphical representation, by using a client computing device 220 connected to the computing device 100 via the Internet 230. The operator can then modify the position from the previous default and/or modify the chosen orthopaedic implant and view new simulation results…” in col. 54, line 66 to col. 55, line 6);
inserting the implant system into the patient using planning and simulation data collected during the planning and simulation steps (Miles discloses “A Surgical plan delivery tool is generated: this includes an actual patient specific jig that would be pinned to the bone and used to cut through, and also provide visual navigation instructions that the Surgeon can follow.” In col. 57, lines 22-25).
Miles fails to expressly teach the following limitations. However, these features are well known in the art, as evidenced by Daley.
In particular, Daley discloses the following:
“collecting interoperative kinematics and soft tissue data about intraoperative changes of the implant system to update planning during insertion of the implant system (Daley discloses “In some examples, the type of surgery may be changed in the operative plan based on data acquired during the surgical operation, such as a partial knee replacement plan may be updated to a total knee replacement plan based on data acquired during the surgical operation.” in col. 4, lines 14-18);
performing postoperative kinematics therapy including movement analysis using the enriched patient-specific kinematic data and intraoperative data collected about the intraoperative changes of the implant system (Daley discloses “…The recorded steps may be compared with patient postoperative data to indicate success or failure of a procedure, and the system and/or method may associate the steps of the ligament transfer procedure with the recorded patient outcome data for use in creating a preoperative plan for a subsequent patient who shares at least one common feature with the individual patient. In some examples, the postoperative data of the patient may include outcome data relating to particular activities of a patient, such a whether the patient is able to walk after a certain amount of time after a total knee replacement.” in col. 23, lines 27-37); and
collecting postoperative kinematics data during the postoperative kinematics therapy as the comparative postoperative kinematic data (Daley discloses “…the aggregation of preoperative plans, measurements, data, secondary preoperative plans, tertiary preoperative plans, final plans and/or outcome measures of surgical procedures creates data which may be analyzed, over a server, on a local electronic access device, electronic surgical device, or surgical robot. …In addition to those discussed above, preoperative data, intra-operative data and/or postoperative data, such as patient data and/or outcome data, may include Electronic Medical Records (EMR) data..” in col. 19, lines 9-58, “…the computer or the robotic systems…may store any changes made to a preoperative plan preoperatively, intraoperatively, or postoperatively…” in col. 20, lines 64-66).”
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include the aforementioned limitation as disclosed by Daley with the motivation of determining success or failure of a procedure (Daley; col. 23, lines 27-29).
Newly added claim 26 recites the method of claim 25, further comprising determining a phenotype of the patient based on the enriched patient-specific kinematic data (Miles; col. 50, lines 53-62).
Newly added claim 27 recites a system for implementing an integrated therapy chain for planning and carrying out insertion of an implant system, the integrated therapy chain having a preoperative therapy step, an intraoperative therapy step, and a postoperative therapy step, the system comprising:
a first data device that collects patient-specific pre-surgery kinematic data during a patient mobility analysis (Miller discloses “…receive, via the data interface, patient specific data for deriving patient data, the patient specific information being indicative of one or more dynamic characteristics;…” in col. 23, lines 30-33, “…the one or more dynamic characteristics comprises a virtual prediction based on one or more of joint kinematics data; joint loading data;…” in col. 23, lines 60-62);
a second data device that collects patient-specific data including demographic information and a patient requirement profile (Miles discloses “…processor…receives…patient specific data…comprising age, gender…” in col. 39, lines 14-50);
a third data device that collects data about the implant system including an implant type, implant orientation, and implant size (Miles discloses “The library data includes library design data for the group of available orthopaedic implants from which the structural parameters of the orthopaetic implants can be derived…” in col. 38, line 57 to col. 39, line 6); and
a control unit for controlling the first data device, the second data device and the third data device, and for performing the preoperative therapy step, the intraoperative therapy step and the postoperative therapy step based on the patient-specific pre-surgery kinematic data, the patient- specific data, and the data about the implant system, the control unit performing operations including: performing the preoperative therapy step, the preoperative therapy step comprising:
enriching the patient-specific pre-surgery kinematic data with comparative postoperative kinematic data to generate enriched patient-specific kinematic data, the comparative postoperative kinematic data comprising historical data similar to the patient- specific pre-surgery kinematic data based on older or earlier insertions of the implant system (Miles discloses “FIG. 3 shows a computer-implemented method 300 for providing alignment information data for the alignment of an orthopaedic implant for a joint of a patient in accordance with an embodiment of the present invention. The computer implemented method 300 is suited for implementation on one or more computing devices 100 and in particular one or more computing devices 100 communicating across a network 200, as substantially shown in FIG. 2. Specifically, Such a computing device 100 comprises a processor 1000 for processing digital data,…” in col. 38, lines 13-22, “The library data also includes library alignment configuration data relating to a group of available orthopaedic implants for performing post-implant activities and library alignment configuration data relating to a group of patients fitted with an orthopaedic implant for performing post-implant activities. The orthopaedic implants may be commercially available orthopaedic implants, or orthopaedic implants that have been customised specifically for previous patients.” in col. 38, lines 48-56);
performing planning regarding implant selection and positioning based on the enriched patient-specific kinematic data and data collected about the implant system (Miles; col. 38, lines 13-22);
performing a simulation to test the planning of insertion of the implant system with regard to mechanical limits of the implant system, taking into account the enriched patient- specific kinematic data and the data collected about the implant system (Miles discloses “A deterministic patient specific rigid body mechanics simulation is performed by the computing device 100, A deterministic model is developed when a simulation is performed on a specific implant position to produce a simulated result.” In col. 54, lines 61-65); and
performing one of approving the planning when the mechanical limits of the implant system have not been exceeded during the simulation, or suggesting a plan modification to comply with the mechanical limits of the implant system (Miles discloses “The operator can view the simulation result of the default position with chosen orthopaedic implants in the form of for example, a graphical representation, by using a client computing device 220 connected to the computing device 100 via the Internet 230. The operator can then modify the position from the previous default and/or modify the chosen orthopaedic implant and view new simulation results…” in col. 54, line 66 to col. 55, line 6);
performing the intraoperative therapy step, the intraoperative therapy step comprising collecting interoperative kinematics and soft tissue data about intraoperative changes of the implant system to update planning during insertion of the implant system into a patient using the planning and simulation data collected during the planning and simulation steps (Miles discloses “aligning the orthopaetic implant” in col. 41, lines 35-55).
Miles fails to expressly teach the following limitations. However, these features are well known in the art, as evidenced by Daley.
In particular, Daley discloses the following:
“performing the postoperative therapy step, the postoperative therapy step comprising:
collecting postoperative kinematics data during postoperative kinematics therapy including movement analysis using the enriched patient-specific kinematic data and intraoperative data collected about the intraoperative changes of the implant system (Daley discloses “In some examples, the type of surgery may be changed in the operative plan based on data acquired during the surgical operation, such as a partial knee replacement plan may be updated to a total knee replacement plan based on data acquired during the surgical operation.” in col. 4, lines 14-18, “…The recorded steps may be compared with patient postoperative data to indicate success or failure of a procedure, and the system and/or method may associate the steps of the ligament transfer procedure with the recorded patient outcome data for use in creating a preoperative plan for a subsequent patient who shares at least one common feature with the individual patient. In some examples, the postoperative data of the patient may include outcome data relating to particular activities of a patient, such a whether the patient is able to walk after a certain amount of time after a total knee replacement.” in col. 23, lines 27-37); and
providing the collected postoperative kinematics data as the comparative postoperative kinematic data (Daley discloses “…the aggregation of preoperative plans, measurements, data, secondary preoperative plans, tertiary preoperative plans, final plans and/or outcome measures of surgical procedures creates data which may be analyzed, over a server, on a local electronic access device, electronic surgical device, or surgical robot. …In addition to those discussed above, preoperative data, intra-operative data and/or postoperative data, such as patient data and/or outcome data, may include Electronic Medical Records (EMR) data..” in col. 19, lines 9-58, “…the computer or the robotic systems…may store any changes made to a preoperative plan preoperatively, intraoperatively, or postoperatively…” in col. 20, lines 64-66).”
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include the aforementioned limitation as disclosed by Daley with the motivation of determining success or failure of a procedure (Daley; col. 23, lines 27-29).
Newly added claim 28 recites the system according to claim 27, wherein the preoperative therapy step further comprises choosing an optimal time for surgery (Miller; col. 58, lines 1-8).
Newly added claim 29 recites the system according to claim 27, wherein the preoperative therapy step includes detecting and processing the patient-specific pre-surgery kinematic data in the first data device and detecting and processing the patient-specific data in the second data device (Miller; col. 58, lines 1-8).
Newly added claim 30 recites the system according to claim 29, wherein the first data device is configured to determine kinematics and a phenotype from the enriched patient-specific kinematic data (Miles; col. 50, lines 53-62).
Newly added claim 31 recites the system according to claim 27, further comprising a fourth data device for storing, processing, and providing image material (Miller; col. 23, lines 17-67).
Newly added claim 32 recites the system according to claim 31, wherein the preoperative therapy step further includes detecting the image material and processing the image material in the fourth data device (Miller; col. 41, lines 4-31).
Newly added claim 33 recites the system according to claim 32, wherein the fourth data device is configured to determine a bone morphology based on the image material (Miller; col. 39, lines 38-50, col. 57, lines 22-25).
Newly added claim 34 recites the system according to claim 33, wherein the preoperative therapy step further includes testing mechanical limits of the implant system based on the planning of the insertion of the implant system, the bone morphology, and an implant orientation (Miller; col. 39, lines 38-50, col. 57, lines 22-25).
Newly added claim 35 recites the system according to claim 27, wherein the preoperative therapy step further includes determining at least an implant type and an implant size based on processed data of at least one of the first data device and the second data device, and the data collected by the third data device (Miller; col. 44, lines 45-65).
Newly added claim 36 recites the system according to claim 27, further comprising a navigation or robotic system, wherein the intraoperative therapy step further comprises implementing the planning of the insertion of the implant system, based on the simulation of the insertion of the implant system, using the navigation or robotic system (Miles discloses “…the orthopaedic implant can be accurately aligned to fit the patient’s joint using either a robotic alignment system, a haptic feedback alignment system, or a computer-assisted alignment system according to the alignment information data derived above. Preferably, the computer-implemented method further comprises the step of: being responsive to the aligned orthopaedic implant for updating a library alignment information database with the alignment information data.” in col. 10, lines 37-46).
Newly added claim 37 recites the system according to claim 27, wherein the postoperative therapy step further includes adapting movement analysis during patient rehabilitation based on the enriched patient-specific kinematic data and a preoperative requirement profile (Miles discloses “Using, for example, a client computing device 220 connected to the computing device 100 via the Internet 230 or a private WAN, the surgeon can view the simulation result of a default position with chosen orthopaedic implants in the form of for example, a graphical representation. The Surgeon can then modify the position from the previous default and/or modify the chosen implant and view new simulation results…” in col. 55, lines 58-65).
Response to Arguments
Applicant's arguments filed 05/01/2026 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed below in the order in which they appear.
Argument about 35 USC 101 rejection:
Applicant argues that newly added claims provide a practical application in the form of a particular treatment for a patient. Applicant argues that presented claims recite a particular treatment for a medical condition (e.g. surgery) that integrates pre-operative, intraoperative and post-operative data collection for improving the surgical implantation of an implant system into a patient.
In response, Examiner submits that claims are directed to providing a suitable treatment for the patient, based on the collected data related to the patient and the implant system. The treatment is not particular, since the claims are directed to collecting data, performing planning regarding implant selection (suitable implant for the patient), performing a simulation test (a well-understood, routine and conventional activity in the field), inserting the implant system into the patient using planning and simulation data collected (insignificant application), collecting data to update the planning (data gathering) and performing post-operative kinematics therapy for the patient (insignificant application), collecting postoperative kinematics data and providing postoperative kinematics data as the comparative postoperative kinematic data (data gathering). Therefore, the treatment is not particular.
Applicant argues that the claimed system provides a novel way to plan and manage the insertion of an implant system for a particular individual using collected preoperative, intraoperative and postoperative data in a data driven control loop, thereby integrating any purported judicial exception into a practical application.
In response, Examiner submits that claims recite preoperative therapy step (planning implant selection an positioning based on collected patient specific and historical/similar data, approving the planning based on the simulation test), intraoperative therapy step (collecting interoperative data, update planning based on data collected during planning and simulation steps), and postoperative therapy step (collecting postoperative data and providing the collected postoperative kinematics data as the comparative postoperative kinematic data/storing the postoperative data in a database). Since these steps correspond to collecting data and updating a database, they are not directed to any practical application.
Applicant argues that claim limitations apply any judicial exception in that the collected data is used in performing the surgical implantation of the implant device, the limitations integrate any purported abstract idea into a practical application.
In response, Examiner submits that claims recite using postoperative kinematic data, that comprises historical data similar to the patient-specific pre-surgery kinematic data based on older or earlier insertions of the implant system. The patient specific postoperative data is being collected and provided as the comparative kinematic data, which corresponds to collecting and storing data. These data are not being used on the specific patient, but may be used for the future, for other patients. Hence, these limitations are directed to gathering data only.
Therefore, the arguments are not persuasive and claims are rejected under 35 U.S.C. §101 as being directed to non-statutory subject matter.
Argument about 35 USC 102 rejection:
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., an integrated pre-, intra- and postoperative therapy chain, adaptive postoperative rehabilitation) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that Miles does not teach a method implementing a simulation as a mechanical safety test in which implant-specific mechanical limits are tested under patient-specific loads.
In response, Examiner submits that Miles teaches “FIG. 14 shows graphical representations of predicted computer simulation results for the change in Varus angle (in degrees) of a knee joint of a patient based on alignment information data calculated using a computer-implemented method in accordance with an embodiment of the present invention;” in col. 35, lines 28-33 and “At step 330, the processor 1000 is further controlled by the computer program code to calculate the alignment information data for aligning the orthopaedic implant for the joint according to the patient data. In this step, the patient data is retrieved from the database 1030 and a deterministic patient specific rigid body mechanics simulation is performed on the patient data using a physics engine, that is, a simulation of the joint using multi-body simulation Software. The simulation is a multi-body simulation which could include the use of forward and/or inverse dynamics in order to produce knee or hip joint simulations. The alignment information data comprises an actual 3D model data of the joint, as obtained from the various 2D and 3D imaging data stored in data 16. From data 15 and data 16, it is possible to generate data corresponding to magnitudes and directions of force vectors, loads, shear stresses, and moments associated with the orthopaedic implant during the simulation. The alignment information data thus takes into consideration both location information data and orientation information data for locating and orienting, respectively, the orthopaedic implant relative to the joint.” in col. 41, lines 35-55.
Applicant argues that Miles does not teach a method that takes into account intraoperative kinematics and soft tissue data to update planning during surgery.
In response, Examiner submits that Miles teaches “Using, for example, a client computing device 220 connected to the computing device 100 via the Internet 230 or a private WAN, the surgeon can view the simulation result of a default position with chosen orthopaedic implants in the form of for example, a graphical representation. The Surgeon can then modify the position from the previous default and/or modify the chosen implant and view new simulation results…” in col. 55, lines 58-65.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., postoperative rehabilitation is not only planned, but also monitored, adapted and feedback based on kinematics collected during postoperative movement analysis, creating a closed data-driven loop) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In particular, claims recite “providing the collected postoperative kinematics data as the comparative postoperative kinematics data” and “enriching the patient-specific pre-surgery kinematic data with comparative postoperative kinematic data to generate enriched patient-specific kinematic data, the comparative postoperative kinematic data comprising historical data similar to the patient-specific pre-surgery kinematic data based on older or earlier insertions of the implant system”. Therefore, the postoperative kinematics data would be used for the future plannings and the claims do not provide any closed data-driven loop, or using the postoperative kinematics data to be used on the particular patient for the particular therapy.
Therefore, the arguments are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DILEK B COBANOGLU/ Primary Examiner, Art Unit 3687
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