DETAILED ACTION
Notices to Applicant
This communication is a Final Office Action on the merits. Claims 1-20 as filed 02/18/2026, are currently pending and have been considered below.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The present application claims priority to U.S. Provisional Application No. 63/387,009, filed 12/12/2022.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Claims 1-10 are drawn to a computer-implemented method for designing patient-specific implant based on a patient-specific interactive surgical plan, which is within the four statutory categories (i.e. method).
Independent Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recites:
1. A computer-implemented method for treating a spinal deformity, the method comprising:
displaying, via a user interface,
a patient-specific interactive surgical plan generated by a surgical planning platform based on one or more images of a patient,
a virtual three-dimensional model representing an anatomy of a spine of the patient, wherein the patient-specific interactive surgical plan includes a user input element for modifying and/or approving the patient-specific interactive surgical plan, wherein the patient-specific interactive surgical plan includes a viewable planned post-operative anatomy for the spine,
obtaining reimbursement information for one or more patient-specific spinal implants based on diagnosis data, procedural data, or pathology data of the patient in the patient-specific interactive surgical plan;
assigning at least one medical reimbursement code to the one or more patient-specific spinal implants based on the reimbursement information; and
receiving, via the user interface, approval of or modification to the planned post-operative anatomy; and
designing the one or more patient-specific spinal implants based on the virtual three-dimensional model and one or more corrective spinal metrics of the spine of the patient to achieve the post-operative anatomy of the spine, and quantify for medical reimbursement based on one or more parameters of the one or more patient-specific spinal implants matching the reimbursement information.
The claim limitations, as drafted, is a method that, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components. That is, other than reciting the above bolded limitations, such as “displaying, via a user interface, a patient-specific interactive surgical plan generated by a surgical planning platform based on one or more images of a patient, a virtual three-dimensional model representing an anatomy of a spine of the patient, wherein the patient-specific interactive surgical plan includes a user input element for modifying and/or approving the patient-specific interactive surgical plan, wherein the patient-specific interactive surgical plan includes a viewable planned post-operative anatomy for the spine” and “receiving, via the user interface, approval of or modification to the planned post-operative anatomy,” nothing in the claim precludes the steps from the managing of personal behavior or interactions between people. For example, but for the above bolded language, obtaining reimbursement information for one or more patient-specific spinal implants based on diagnosis data, procedural data, or pathology data of the patient in the patient-specific interactive surgical plan; assigning at least one medical reimbursement code to the one or more patient-specific spinal implants based on the reimbursement information; and designing the one or more patient-specific spinal implants based on the virtual three-dimensional model and one or more corrective spinal metrics of the spine of the patient to achieve the post-operative anatomy of the spine, and quantify for medical reimbursement based on one or more parameters of the one or more patient-specific spinal implants matching the reimbursement information in the context of this claim encompasses the managing of personal behavior or interactions between people through following rules or instructions for designing a patient specific implant achieving the approved planned post-operative pathology and for medical reimbursement under the at least one medical reimbursement code. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements of using, for example, “displaying, via a user interface, a patient-specific interactive surgical plan generated by a surgical planning platform based on one or more images of a patient, a virtual three-dimensional model representing an anatomy of a spine of the patient, wherein the patient-specific interactive surgical plan includes a user input element for modifying and/or approving the patient-specific interactive surgical plan, wherein the patient-specific interactive surgical plan includes a viewable planned post-operative anatomy for the spine” and “receiving, via the user interface, approval of or modification to the planned post-operative anatomy,” to perform the claim limitations. The additional elements in each of these steps are recited at a high-level of generality (i.e., a display on a client computing device including a graphical user interface for outputting the treatment plan(s) and with input elements (e.g. one or more buttons, a dropdown menu, toggle, etc.) and a surgical planning platform included on a server as they relate to general purpose computer components (Application Specification [0039], [0057], [0070], [0164])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.05(f). 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 claim is directed to an abstract idea.
The claim does 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 above bolded additional elements of using, for example, “displaying, via a user interface, a patient-specific interactive surgical plan generated by a surgical planning platform based on one or more images of a patient, a virtual three-dimensional model representing an anatomy of a spine of the patient, wherein the patient-specific interactive surgical plan includes a user input element for modifying and/or approving the patient-specific interactive surgical plan, wherein the patient-specific interactive surgical plan includes a viewable planned post-operative anatomy for the spine” and “receiving, via the user interface, approval of or modification to the planned post-operative anatomy,” to perform the claim limitations amounts to no more than mere instructions to apply the exception using a generic computer component. (i.e., a display on a client computing device including a graphical user interface for outputting the treatment plan(s) and with input elements (e.g. one or more buttons, a dropdown menu, toggle, etc.) and a surgical planning platform included on a server as they relate to general purpose computer components (Application Specification [0039], [0057], [0070], [0164])). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See MPEP 2106.05(f). The claim is not patent eligible.
Dependent claims 2-10 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the managing of personal behavior or interactions between people through following rules or instructions for designing a patient specific implant achieving the approved planned post-operative pathology and for medical reimbursement under the at least one medical reimbursement code. Dependent claim 2 recites the additional elements “store, via a regulatory and reimbursement manager …;” “generate a virtual three-dimensional model representing a patient’s anatomy;” and “manipulate the virtual three-dimensional model;” claim 3 recites “displaying a comparison,” claim 5 recites “displaying a user inputted modification,” claim 6 recites “displaying one or more user adjustable values, an anatomical correction …, and reimbursement information,” claim 7 recites “displaying verification …; and displaying pricing,” however, each of these additional elements are recited at a high-level such that they amount to using generic computer components as a tool to perform storing, generating, and manipulating functions. See Application Specification at [0028], [0039], [0057], [0070]. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the dependent claims are rejected under 35 U.S.C. § 101.
Claims 11-15 are drawn to a system for designing patient-specific implant based on a patient-specific interactive surgical plan, which is within the four statutory categories (i.e. machine).
Independent Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 11 recites:
11. A system comprising: one or more processors; and one or more memories storing instructions that, when executed by the one or more processors, cause the system to perform a process comprising:
displaying, via a user interface,
a patient-specific interactive surgical plan generated by a surgical planning platform based on one or more images of a patient,
a virtual three-dimensional model representing an anatomy of a spine of the patient
wherein the user interface includes a user input element for modifying and/or approving the patient-specific interactive surgical plan, wherein the patient-specific interactive surgical plan includes a viewable planned post-operative anatomy for the spine;
obtaining reimbursement information for one or more patient-specific spinal implants based on diagnosis data, procedural data, or pathology data of the patient in the patient-specific interactive surgical plan;
assigning at least one medical reimbursement code to the one or more patient-specific spinal implants based on the reimbursement information; and
receiving, via the user interface, approval of or modification to the planned post-operative anatomy; and
designing the one or more patient-specific spinal implants based on the virtual three-dimensional model and one or more corrective spinal metrics of the spine of the patient to achieve the post-operative anatomy of the spine, and quantify for medical reimbursement based on one or more parameters of the one or more patient-specific spinal implants matching the reimbursement information.
The claim limitations, as drafted, is a system that, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components. That is, other than reciting the above bolded limitations, such as “one or more processors; and one or more memories storing instructions that, when executed by the one or more processors, cause the system to perform a process comprising: displaying, via a user interface, a patient-specific interactive surgical plan generated by a surgical planning platform based on one or more images of a patient, a virtual three-dimensional model representing an anatomy of a spine of the patient, wherein the user interface includes a user input element for modifying and/or approving the patient-specific interactive surgical plan, wherein the patient-specific interactive surgical plan includes a viewable planned post-operative anatomy for the spine,” and “receiving, via the user interface, approval of or modification to the planned post-operative anatomy,” nothing in the claim precludes the steps from the managing of personal behavior or interactions between people. For example, but for the above bolded language, obtaining reimbursement information for one or more patient-specific spinal implants based on diagnosis data, procedural data, or pathology data of the patient in the patient-specific interactive surgical plan; assigning at least one medical reimbursement code to the one or more patient-specific spinal implants based on the reimbursement information; and designing the one or more patient-specific spinal implants based on the virtual three-dimensional model and one or more corrective spinal metrics of the spine of the patient to achieve the post-operative anatomy of the spine, and quantify for medical reimbursement based on one or more parameters of the one or more patient-specific spinal implants matching the reimbursement information in the context of this claim encompasses the managing of personal behavior or interactions between people through following rules or instructions for designing a patient specific implant achieving the approved planned post-operative pathology and for medical reimbursement under the at least one medical reimbursement code. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements of using, for example, “one or more processors; and one or more memories storing instructions that, when executed by the one or more processors, cause the system to perform a process comprising: displaying, via a user interface, a patient-specific interactive surgical plan generated by a surgical planning platform based on one or more images of a patient, a virtual three-dimensional model representing an anatomy of a spine of the patient, wherein the user interface includes a user input element for modifying and/or approving the patient-specific interactive surgical plan, wherein the patient-specific interactive surgical plan includes a viewable planned post-operative anatomy for the spine,” and “receiving, via the user interface, approval of or modification to the planned post-operative anatomy,” to perform the claim limitations. The additional elements in each of these steps are recited at a high-level of generality (i.e., a memory such as volatile and non-volatile memory, processors such as microprocessors and digital signal processors; a display on a client computing device including a graphical user interface for outputting the treatment plan(s) and with input elements (e.g. one or more buttons, a dropdown menu, toggle, etc.) and a surgical planning platform included on a server as they relate to general purpose computer components (Application Specification [0039], [0057], [0070], [0164])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.05(f). 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 claim is directed to an abstract idea.
The claim does 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 above bolded additional elements of using , for example “one or more processors; and one or more memories storing instructions that, when executed by the one or more processors, cause the system to perform a process comprising: displaying, via a user interface, a patient-specific interactive surgical plan generated by a surgical planning platform based on one or more images of a patient, a virtual three-dimensional model representing an anatomy of a spine of the patient, wherein the user interface includes a user input element for modifying and/or approving the patient-specific interactive surgical plan, wherein the patient-specific interactive surgical plan includes a viewable planned post-operative anatomy for the spine,” and “receiving, via the user interface, approval of or modification to the planned post-operative anatomy,” to perform the claim limitations amounts to no more than mere instructions to apply the exception using a generic computer component. (i.e., a memory such as volatile and non-volatile memory, processors such as microprocessors and digital signal processors; a display on a client computing device including a graphical user interface for outputting the treatment plan(s) and with input elements (e.g. one or more buttons, a dropdown menu, toggle, etc.) and a surgical planning platform included on a server as they relate to general purpose computer components (Application Specification [0039], [0057], [0070], [0164])). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See MPEP 2106.05(f). The claim is not patent eligible.
Dependent claims 12-15 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the managing of personal behavior or interactions between people through following rules or instructions for designing a patient specific implant achieving the approved planned post-operative pathology and for medical reimbursement under the at least one medical reimbursement code. Dependent claim 12 recites the additional elements “storing, via a regulatory and reimbursement manager …;” “generating a virtual three-dimensional model representing a patient’s anatomy;” and “manipulating the virtual three-dimensional model;” claim 13 recites “displaying a comparison,” and claim 15 recites “displaying a user inputted modification,” however, each of these additional elements are recited at a high-level such that they amount to using generic computer components as a tool to perform storing, generating, and manipulating functions. See Application Specification at [0028], [0039], [0057], [0070]. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the dependent claims are rejected under 35 U.S.C. § 101.
Claims 16-20 are drawn to a non-transitory computer-readable medium for designing patient-specific implant based on a patient-specific interactive surgical plan, which is within the four statutory categories (i.e. manufacture).
Independent Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 16 recites:
16. A non-transitory computer-readable medium storing instructions that, when executed by a computing system, cause the computing system to perform operations comprising:
displaying, via a user interface,
a patient-specific interactive surgical plan generated by a surgical planning platform based on one or more images of a patient,
a virtual three-dimensional model representing an anatomy of a spine of the patient,
wherein the user interface includes a user input element for modifying and/or approving the patient-specific interactive surgical plan, wherein the patient-specific interactive surgical plan includes a viewable planned post-operative anatomy for the spine,
obtaining reimbursement information for one or more patient-specific spinal implants based on diagnosis data, procedural data, or pathology data of the patient in the patient-specific interactive surgical plan;
assigning at least one medical reimbursement code to the one or more patient- specific spinal implants based on the reimbursement information; and
receiving, via the user interface, approval of or modification to the planned post-operative anatomy; and
designing the one or more patient-specific spinal implants based on the virtual three-dimensional model and one or more corrective spinal metrics of the spine of the patient to achieve the post-operative anatomy of the spine, and quantify for medical reimbursement based on one or more parameters of the one or more patient-specific spinal implants matching the reimbursement information. .
The claim limitations, as drafted, is a system that, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components. That is, other than reciting the above bolded limitations, such as “a non-transitory computer-readable medium storing instructions that, when executed by a computing system, cause the computing system to perform operations comprising: displaying, via a user interface, a patient-specific interactive surgical plan generated by a surgical planning platform based on one or more images of a patient, a virtual three-dimensional model representing an anatomy of a spine of the patient, wherein the user interface includes a user input element for modifying and/or approving the patient-specific interactive surgical plan, wherein the patient-specific interactive surgical plan includes a viewable planned post-operative anatomy for the spine,” and “receiving, via the user interface, approval of or modification to the planned post-operative anatomy,” nothing in the claim precludes the steps from the managing of personal behavior or interactions between people. For example, but for the above bolded language, obtaining reimbursement information for one or more patient-specific spinal implants based on diagnosis data, procedural data, or pathology data of the patient in the patient-specific interactive surgical plan; assigning at least one medical reimbursement code to the one or more patient-specific spinal implants based on the reimbursement information; and designing the one or more patient-specific spinal implants based on the virtual three-dimensional model and one or more corrective spinal metrics of the spine of the patient to achieve the post-operative anatomy of the spine, and quantify for medical reimbursement based on one or more parameters of the one or more patient-specific spinal implants matching the reimbursement information in the context of this claim encompasses the managing of personal behavior or interactions between people through following rules or instructions for designing a patient specific implant achieving the approved planned post-operative pathology and for medical reimbursement under the at least one medical reimbursement code. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements of using, for example, “a non-transitory computer-readable medium storing instructions that, when executed by a computing system, cause the computing system to perform operations comprising: displaying, via a user interface, a patient-specific interactive surgical plan generated by a surgical planning platform based on one or more images of a patient, a virtual three-dimensional model representing an anatomy of a spine of the patient, wherein the user interface includes a user input element for modifying and/or approving the patient-specific interactive surgical plan, wherein the patient-specific interactive surgical plan includes a viewable planned post-operative anatomy for the spine,” and “receiving, via the user interface, approval of or modification to the planned post-operative anatomy,” to perform the claim limitations. The additional elements in each of these steps are recited at a high-level of generality (i.e., a memory such as volatile and non-volatile memory, processors such as microprocessors and digital signal processors; a display on a client computing device including a graphical user interface for outputting the treatment plan(s) and with input elements (e.g. one or more buttons, a dropdown menu, toggle, etc.) and a surgical planning platform included on a server as they relate to general purpose computer components (Application Specification [0039], [0057], [0070], [0164])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.05(f). 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 claim is directed to an abstract idea.
The claim does 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 above bolded additional elements of using , for example, “a non-transitory computer-readable medium storing instructions that, when executed by a computing system, cause the computing system to perform operations comprising: displaying, via a user interface, a patient-specific interactive surgical plan generated by a surgical planning platform based on one or more images of a patient, a virtual three-dimensional model representing an anatomy of a spine of the patient, wherein the user interface includes a user input element for modifying and/or approving the patient-specific interactive surgical plan, wherein the patient-specific interactive surgical plan includes a viewable planned post-operative anatomy for the spine,” and “receiving, via the user interface, approval of or modification to the planned post-operative anatomy,” to perform the claim limitations amounts to no more than mere instructions to apply the exception using a generic computer component. (i.e., a memory such as volatile and non-volatile memory, processors such as microprocessors and digital signal processors; a display on a client computing device including a graphical user interface for outputting the treatment plan(s) and with input elements (e.g. one or more buttons, a dropdown menu, toggle, etc.) and a surgical planning platform included on a server as they relate to general purpose computer components (Application Specification [0039], [0057], [0070], [0164])). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See MPEP 2106.05(f). The claim is not patent eligible.
Dependent claims 18-20 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the managing of personal behavior or interactions between people through following rules or instructions for designing a patient specific implant achieving the approved planned post-operative pathology and for medical reimbursement under the at least one medical reimbursement code. Dependent claim 17 recites the additional elements “storing, via a regulatory and reimbursement manager …;” “generating a virtual three-dimensional model representing a patient’s anatomy;” and “manipulating the virtual three-dimensional model;” claim 18 recites “displaying a comparison,” and claim 20 recites “displaying a user inputted modification,” however, each of these additional elements are recited at a high-level such that they amount to using generic computer components as a tool to perform storing, generating, and manipulating functions. See Application Specification at [0028], [0039], [0057], [0070]. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the dependent claims are rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4-6, 8-9, 11, 14-16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2023/0048940 A1 (hereinafter “Kontaxis et al.”) in view of U.S. 2023/0023083 A1 (hereinafter “Shelton IV et al.”).
RE: Claim 1 (Currently Amended) Kontaxis et al. teaches the claimed:
1. A computer-implemented method for designing patient-specific implant based on a patient-specific interactive surgical plan, the method comprising: displaying, via a user interface, a patient-specific interactive surgical plan generated by a surgical planning platform based on one or more images of a patient ((Kontaxis et al., [0043], [0049]-[0051]) (It is to be appreciated that one or more of a GUI, UI alone, in combination or used in conjunction with computer enabled operations and/or functions permit the various biomechanical, kinematic, wear, impingement, localization and other factors and variations described herein and utilized in this analysis to be accomplished virtually based on images taken from a subject or patient prior to surgery with all some or none of the various modifications described herein; The method 100 includes representative steps 105-140 of an exemplary method 100 of conducting a patient specific pre-surgical planning for replacement of a joint; First, at step 105, there is the step of obtaining patient specific imaging data of the upper extremity including the shoulder. Next, at step 110, there is the step of rendering a modified patient specific computer generated model of the joint to be surgically modified; Exemplary other joints include, in addition to the shoulder, the hip, the elbow, the wrist, the ankle, the spine, the knee, the joints of the hand including the fingers and thumbs, and the joints of the feet including the toes. Modifications to the general computer model may be obtained from examination of the patient or other patient specific data including information obtained from the patient specific imaging data));
a virtual three-dimensional model representing an anatomy of a spine of a patient ((Kontaxis et al., [0049], [0104) (Exemplary other joints include, in addition to the shoulder, the hip, the elbow, the wrist, the ankle, the spine, the knee, the joints of the hand including the fingers and thumbs, and the joints of the feet including the toes; this computer readable model representing a complete or a partial patient specific bone, muscle, ligaments and other joint physiology for 3D surgical planning employing kinematic and biomechanical analysis. In some aspects, the majority of the modeling information reflects data from the patient specifically));
wherein the user interface includes a user input element for modifying and/or approving the patient-specific interactive surgical plan ((Kontaxis et al., [0043]) (It is to be appreciated that one or more of a GUI, UI alone, in combination or used in conjunction with computer enabled operations and/or functions permit the various biomechanical, kinematic, wear, impingement, localization and other factors and variations described herein and utilized in this analysis to be accomplished virtually based on images taken from a subject or patient prior to surgery with all some or none of the various modifications described herein; Next, at step 115, there is the step of selected a joint based surgical procedure. Next at step 120 is the step of selecting a prosthetic implant, an implant location and degree, amount, type of surgical intervention. This step includes the computer based or electronic alteration of the patient specific model to reflect the surgical modification to the joint to position and secure the selected prosthetic implant));
wherein the patient-specific interactive surgical plan includes a viewable planned post-operative anatomy for the spine ((Kontaxis et al., [0054], [0055]) (Next at step 125 is the step of performing kinematic simulation for one or more activities of daily living and/or one or more standard clinical assessments. This step provides information about the durability of the selected implant in the planned position as a variety of different motions are imparted to the modeled joint; Next at step 130 is the output of the results of the operation of the patient specific kinematic model based on those actions evaluated in step 125. This step provides an output assessment including scoring, rating, characteristic, quality ranking for the selected implant-location-procedure evaluated in step 125));
receiving, via the user interface, approval of or modification to the planned post-operative anatomy ((Kontaxis et al., [0043], [0078]) (Next, at step 115, there is the step of selected a joint based surgical procedure. Next at step 120 is the step of selecting a prosthetic implant, an implant location and degree, amount, type of surgical intervention. This step includes the computer based or electronic alteration of the patient specific model to reflect the surgical modification to the joint to position and secure the selected prosthetic implant; the disclosed pre-operative planning methods can further comprise identifying a prosthetic shoulder implant for use during an anatomic shoulder or a reverse shoulder total or partial arthroplasty, including designing a patient-specific augmented humeral implant, patient specific augmented glenoid implant, and/or identifying a placement position for the prosthetic shoulder implant including anatomic or reverse procedures and including options for digital models of standard sized implants, custom implants or patient derived implants));
designing the one or more patient-specific spinal implants based on the virtual three-dimensional model and one or more corrective spinal metrics of the spine of the patient to achieve the post-operative anatomy of the spine, […] ((Kontaxis et al., [0056]-[0057], [0124]) (for all selected implants, locations or procedures for the patient specific joint surgery. In this way, information obtained from prior implant selections or proposed surgical locations may be further refined or altered in order to provide a range of suitable surgical options for consideration based on patient specific conditions and expected or desired post-surgical activities of daily living. Finally, step 140 reflects the output of the method as an assessment of all tested implants and surgical locations. There is a summary output that includes the ranking, scoring, comparison graphics for all selected or evaluated implants, locations or procedures; to design components produced during the additive manufacturing process in support of the patient specific joint surgery described herein)).
Kontaxis et al fails to explicitly teach, but Shelton IV et al. teaches the claimed:
obtaining reimbursement information for one or more patient-specific spinal implants based on diagnosis data, procedural data, or pathology data of the patient in the patient-specific interactive surgical plan; assigning at least one medical reimbursement code to the one or more patient-specific spinal implants based on the reimbursement information ((Shelton IV et al., [0568], [0569], [0573]) (The global analyses be useful for changes in best-practices, new reimbursement codes, etc.; Analysis by the edge cloud system may compare specific billing to one of more of patient outcomes, most successful reimbursement and reimbursement code usage, and/or best starting point procedures to be most successful for reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc.));
[…] quantify for medical reimbursement based on one or more parameters of the one or more patient-specific spinal implants matching the reimbursement information ((Shelton IV et al., [0573]) (a procedure's reimbursement rate may be used with the outcomes data to instruct surgical procedure plan(s) and/or recovery plan(s). In an example, reimbursement data from billing system 43668 (e.g., a system from data systems 43610 through 43612 in FIG. 36) and outcomes data from surgical hub #1 and surgical hub #2 in OR 43662 and OR 43664, respectively, may be balanced to identify value-added treatments as a starting point for surgical procedure plan(s) and/or recovery plan(s))).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine analysis of reimbursement and most successful reimbursement codes compared to outcomes to identify and instruct surgical procedure plans as taught by Shelton IV et al. within the method and system preoperative planned surgery including designing implants as taught by Kontaxis et al. with the motivation of most successfully provide reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc. (Shelton IV et al. [0569]).
RE: Claim 4 (Currently Amended) Kontaxis et al. and Shelton IV et al. teach the claimed:
4. The computer-implemented method of claim 1, wherein the patient-specific interactive surgical plan includes one or more regulatory indication values associated with a treatment provided by the one or more patient-specific spinal implants ((Kontaxis et al., [0130]) (Including digital models of components from manufactures listed below or digital models of the products listed below or of all selected products having regulatory approval)).
RE: Claim 5 Kontaxis et al. and Shelton IV et al. teach the claimed:
5. The computer-implemented method of claim 1, further comprising: displaying a user inputted modification to the patient-specific interactive surgical plan; and dynamically updating at least one of regulatory approval or reimbursement information, wherein the updating is based on the user inputted modification ((Kontaxis et al., [0066]-[0067]) (there is a determination of whether to select a different prosthesis, manufacturer, model, size or further surgeon based input to modify location, size or other factors for the surgical procedure being evaluated. If the answer at 240 is "YES" then the process loops back to step to decision 205 for selecting a new prosthesis for testing and then method repeats for that additional prosthesis. If the answer at 240 is "NO" then the process continues to step 245. At step 245, there is an output of all of the patient specific assessments collected i.e. dynamically output based on surgeon input; Moreover, the output includes the impact on selected activity of daily living and standard clinical tests for all selected prosthesis manufacturer, models and sizes for each tested implantation site)).
RE: Claim 6 Kontaxis et al. and Shelton IV et al. teach the claimed:
6. The computer-implemented method of claim 1, further comprising displaying one or more user adjustable values, an anatomical correction based on the one or more user adjustable values ((Kontaxis et al., [0117]) (The software includes tools for the surgeon to micro adapt or make small adjustments or modifications to selected surgical implant locations and recommendations so that the specific implant location may be driven by specific surgeon inputs)).
Kontaxis et al fails to explicitly teach, but Shelton IV et al. teaches the claimed:
and reimbursement information associated with treatment for achieving the anatomical correction ((Shelton IV et al., [0568], [0569]) (The global analyses be useful for changes in best-practices, new reimbursement codes, etc.; Analysis by the edge cloud system may compare specific billing to one of more of patient outcomes, most successful reimbursement and reimbursement code usage, and/or best starting point procedures to be most successful for reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc.; a procedure's reimbursement rate may be used with the outcomes data to instruct surgical procedure plan(s) and/or recovery plan(s). In an example, reimbursement data from billing system 43668 (e.g., a system from data systems 43610 through 43612 in FIG. 36) and outcomes data from surgical hub #1 and surgical hub #2 in OR 43662 and OR 43664, respectively, may be balanced to identify value-added treatments as a starting point for surgical procedure plan(s) and/or recovery plan(s))).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine analysis of reimbursement and most successful reimbursement codes compared to outcomes to identify and instruct surgical procedure plans as taught by Shelton IV et al. within the method and system preoperative planned surgery including designing implants as taught by Kontaxis et al. with the motivation of most successfully provide reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc. (Shelton IV et al. [0569]).
RE: Claim 8 Kontaxis et al. and Shelton IV et al. teach the claimed:
8. The computer-implemented method of claim 1, further comprising: obtaining one or more pre-operative metrics for pre-determined indications; and obtaining one or more post-operative metrics to validate a target outcome for the pre- determined indications ((Kontaxis et al., [0137]) (clinical Case Series having acceptance criteria description of a pre-operative plan compared to post-operative implant position verification and validation results as acceptable)).
RE: Claim 9 Kontaxis et al. and Shelton IV et al. teach the claimed:
9. The computer-implemented method of claim 1, wherein the obtained reimbursement information includes at least one of treatment type or description of treatment ((Shelton IV et al., [0568], [0573]) (The global analyses may use larger subject populations ( e.g., millions) and may lack the resolution of specific costs and/or specific treatments. The global analyses be useful for changes in best-practices, new reimbursement codes, etc. Longitudinal databases used in the global analyses may track specific patients through time to analyze complications, medication, and/or patient response to treatments; a procedure's reimbursement rate may be used with the outcomes data to instruct surgical procedure plan(s) and/or recovery plan(s))).
RE: Claim 11 (Currently Amended) Kontaxis et al. teaches the claimed:
11. A system comprising: one or more processors; and one or more memories storing instructions that, when executed by the one or more processors, cause the system to perform a process comprising: displaying, via a user interface, a patient-specific interactive surgical plan generated by a surgical planning platform based on one or more images of a patient ((Kontaxis et al., [0010], [0043], [0049]-[0051]) (a computer readable medium having instructions executed by a processor; It is to be appreciated that one or more of a GUI, UI alone, in combination or used in conjunction with computer enabled operations and/or functions permit the various biomechanical, kinematic, wear, impingement, localization and other factors and variations described herein and utilized in this analysis to be accomplished virtually based on images taken from a subject or patient prior to surgery with all some or none of the various modifications described herein; The method 100 includes representative steps 105-140 of an exemplary method 100 of conducting a patient specific pre-surgical planning for replacement of a joint; First, at step 105, there is the step of obtaining patient specific imaging data of the upper extremity including the shoulder. Next, at step 110, there is the step of rendering a modified patient specific computer generated model of the joint to be surgically modified; Exemplary other joints include, in addition to the shoulder, the hip, the elbow, the wrist, the ankle, the spine, the knee, the joints of the hand including the fingers and thumbs, and the joints of the feet including the toes. Modifications to the general computer model may be obtained from examination of the patient or other patient specific data including information obtained from the patient specific imaging data));
a virtual three-dimensional model representing an anatomy of a spine of a patient ((Kontaxis et al., [0049], [0104) (Exemplary other joints include, in addition to the shoulder, the hip, the elbow, the wrist, the ankle, the spine, the knee, the joints of the hand including the fingers and thumbs, and the joints of the feet including the toes; this computer readable model representing a complete or a partial patient specific bone, muscle, ligaments and other joint physiology for 3D surgical planning employing kinematic and biomechanical analysis. In some aspects, the majority of the modeling information reflects data from the patient specifically));
wherein the user interface includes a user input element for modifying and/or approving the patient-specific interactive surgical plan ((Kontaxis et al., [0043]) (It is to be appreciated that one or more of a GUI, UI alone, in combination or used in conjunction with computer enabled operations and/or functions permit the various biomechanical, kinematic, wear, impingement, localization and other factors and variations described herein and utilized in this analysis to be accomplished virtually based on images taken from a subject or patient prior to surgery with all some or none of the various modifications described herein; Next, at step 115, there is the step of selected a joint based surgical procedure. Next at step 120 is the step of selecting a prosthetic implant, an implant location and degree, amount, type of surgical intervention. This step includes the computer based or electronic alteration of the patient specific model to reflect the surgical modification to the joint to position and secure the selected prosthetic implant));
wherein the patient-specific interactive surgical plan includes a viewable planned post-operative anatomy for the spine ((Kontaxis et al., [0054], [0055]) (Next at step 125 is the step of performing kinematic simulation for one or more activities of daily living and/or one or more standard clinical assessments. This step provides information about the durability of the selected implant in the planned position as a variety of different motions are imparted to the modeled joint; Next at step 130 is the output of the results of the operation of the patient specific kinematic model based on those actions evaluated in step 125. This step provides an output assessment including scoring, rating, characteristic, quality ranking for the selected implant-location-procedure evaluated in step 125));
receiving, via the user interface, approval of or modification to the planned post-operative anatomy ((Kontaxis et al., [0043], [0078]) (Next, at step 115, there is the step of selected a joint based surgical procedure. Next at step 120 is the step of selecting a prosthetic implant, an implant location and degree, amount, type of surgical intervention. This step includes the computer based or electronic alteration of the patient specific model to reflect the surgical modification to the joint to position and secure the selected prosthetic implant; the disclosed pre-operative planning methods can further comprise identifying a prosthetic shoulder implant for use during an anatomic shoulder or a reverse shoulder total or partial arthroplasty, including designing a patient-specific augmented humeral implant, patient specific augmented glenoid implant, and/or identifying a placement position for the prosthetic shoulder implant including anatomic or reverse procedures and including options for digital models of standard sized implants, custom implants or patient derived implants));
designing the one or more patient-specific spinal implants based on the virtual three-dimensional model and one or more corrective spinal metrics of the spine of the patient to achieve the post-operative anatomy of the spine, […] ((Kontaxis et al., [0056]-[0057], [0124]) (for all selected implants, locations or procedures for the patient specific joint surgery. In this way, information obtained from prior implant selections or proposed surgical locations may be further refined or altered in order to provide a range of suitable surgical options for consideration based on patient specific conditions and expected or desired post-surgical activities of daily living. Finally, step 140 reflects the output of the method as an assessment of all tested implants and surgical locations. There is a summary output that includes the ranking, scoring, comparison graphics for all selected or evaluated implants, locations or procedures; to design components produced during the additive manufacturing process in support of the patient specific joint surgery described herein)).
Kontaxis et al fails to explicitly teach, but Shelton IV et al. teaches the claimed:
obtaining reimbursement information for one or more patient-specific spinal implants based on diagnosis data, procedural data, or pathology data of the patient in the patient-specific interactive surgical plan; assigning at least one medical reimbursement code to the one or more patient-specific spinal implants based on the reimbursement information ((Shelton IV et al., [0568],, [0569], [0573]) (The global analyses be useful for changes in best-practices, new reimbursement codes, etc.; Analysis by the edge cloud system may compare specific billing to one of more of patient outcomes, most successful reimbursement and reimbursement code usage, and/or best starting point procedures to be most successful for reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc.));
[…] quantify for medical reimbursement based on one or more parameters of the one or more patient-specific spinal implants matching the reimbursement information ((Shelton IV et al., [0573]) (a procedure's reimbursement rate may be used with the outcomes data to instruct surgical procedure plan(s) and/or recovery plan(s). In an example, reimbursement data from billing system 43668 (e.g., a system from data systems 43610 through 43612 in FIG. 36) and outcomes data from surgical hub #1 and surgical hub #2 in OR 43662 and OR 43664, respectively, may be balanced to identify value-added treatments as a starting point for surgical procedure plan(s) and/or recovery plan(s))).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine analysis of reimbursement and most successful reimbursement codes compared to outcomes to identify and instruct surgical procedure plans as taught by Shelton IV et al. within the method and system preoperative planned surgery including designing implants as taught by Kontaxis et al. with the motivation of most successfully provide reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc. (Shelton IV et al. [0569]).
RE: Claim 14 (Currently Amended) Kontaxis et al. and Shelton IV et al. teach the claimed:
14. The system of claim 11, wherein the patient-specific interactive surgical plan includes one or more regulatory indication values associated with a treatment provided by the one or more patient-specific spinal implants ((Kontaxis et al., [0130]) (Including digital models of components from manufactures listed below or digital models of the products listed below or of all selected products having regulatory approval)).
RE: Claim 15 Kontaxis et al. and Shelton IV et al. teach the claimed:
15. The system of claim 11, wherein the process further includes: displaying a user inputted modification to the patient-specific interactive surgical plan; and dynamically updating at least one of regulatory approval or reimbursement information, wherein the updating is based on the user inputted modification ((Kontaxis et al., [0066]-[0067]) (there is a determination of whether to select a different prosthesis, manufacturer, model, size or further surgeon based input to modify location, size or other factors for the surgical procedure being evaluated. If the answer at 240 is "YES" then the process loops back to step to decision 205 for selecting a new prosthesis for testing and then method repeats for that additional prosthesis. If the answer at 240 is "NO" then the process continues to step 245. At step 245, there is an output of all of the patient specific assessments collected i.e. dynamically output based on surgeon input; Moreover, the output includes the impact on selected activity of daily living and standard clinical tests for all selected prosthesis manufacturer, models and sizes for each tested implantation site)).
RE: Claim 16 (Currently Amended) Kontaxis et al. teaches the claimed:
16. A non-transitory computer-readable medium storing instructions that, when executed by a computing system, cause the computing system to perform operations comprising: displaying, via a user interface, a patient-specific interactive surgical plan generated by a surgical planning platform based on one or more images of a patient ((Kontaxis et al., [0010], [0043], [0049]-[0051]) (a computer readable medium having instructions executed by a processor; It is to be appreciated that one or more of a GUI, UI alone, in combination or used in conjunction with computer enabled operations and/or functions permit the various biomechanical, kinematic, wear, impingement, localization and other factors and variations described herein and utilized in this analysis to be accomplished virtually based on images taken from a subject or patient prior to surgery with all some or none of the various modifications described herein; The method 100 includes representative steps 105-140 of an exemplary method 100 of conducting a patient specific pre-surgical planning for replacement of a joint; First, at step 105, there is the step of obtaining patient specific imaging data of the upper extremity including the shoulder. Next, at step 110, there is the step of rendering a modified patient specific computer generated model of the joint to be surgically modified; Exemplary other joints include, in addition to the shoulder, the hip, the elbow, the wrist, the ankle, the spine, the knee, the joints of the hand including the fingers and thumbs, and the joints of the feet including the toes. Modifications to the general computer model may be obtained from examination of the patient or other patient specific data including information obtained from the patient specific imaging data));
a virtual three-dimensional model representing an anatomy of a spine of a patient ((Kontaxis et al., [0049], [0104) (Exemplary other joints include, in addition to the shoulder, the hip, the elbow, the wrist, the ankle, the spine, the knee, the joints of the hand including the fingers and thumbs, and the joints of the feet including the toes; this computer readable model representing a complete or a partial patient specific bone, muscle, ligaments and other joint physiology for 3D surgical planning employing kinematic and biomechanical analysis. In some aspects, the majority of the modeling information reflects data from the patient specifically));
wherein the user interface includes a user input element for modifying and/or approving the patient-specific interactive surgical plan ((Kontaxis et al., [0043]) (It is to be appreciated that one or more of a GUI, UI alone, in combination or used in conjunction with computer enabled operations and/or functions permit the various biomechanical, kinematic, wear, impingement, localization and other factors and variations described herein and utilized in this analysis to be accomplished virtually based on images taken from a subject or patient prior to surgery with all some or none of the various modifications described herein; Next, at step 115, there is the step of selected a joint based surgical procedure. Next at step 120 is the step of selecting a prosthetic implant, an implant location and degree, amount, type of surgical intervention. This step includes the computer based or electronic alteration of the patient specific model to reflect the surgical modification to the joint to position and secure the selected prosthetic implant));
wherein the patient-specific interactive surgical plan includes a viewable planned post-operative anatomy for the spine ((Kontaxis et al., [0054], [0055]) (Next at step 125 is the step of performing kinematic simulation for one or more activities of daily living and/or one or more standard clinical assessments. This step provides information about the durability of the selected implant in the planned position as a variety of different motions are imparted to the modeled joint; Next at step 130 is the output of the results of the operation of the patient specific kinematic model based on those actions evaluated in step 125. This step provides an output assessment including scoring, rating, characteristic, quality ranking for the selected implant-location-procedure evaluated in step 125));
receiving, via the user interface, approval of or modification to the planned post-operative anatomy ((Kontaxis et al., [0043], [0078]) (Next, at step 115, there is the step of selected a joint based surgical procedure. Next at step 120 is the step of selecting a prosthetic implant, an implant location and degree, amount, type of surgical intervention. This step includes the computer based or electronic alteration of the patient specific model to reflect the surgical modification to the joint to position and secure the selected prosthetic implant; the disclosed pre-operative planning methods can further comprise identifying a prosthetic shoulder implant for use during an anatomic shoulder or a reverse shoulder total or partial arthroplasty, including designing a patient-specific augmented humeral implant, patient specific augmented glenoid implant, and/or identifying a placement position for the prosthetic shoulder implant including anatomic or reverse procedures and including options for digital models of standard sized implants, custom implants or patient derived implants));
designing the one or more patient-specific spinal implants based on the virtual three-dimensional model and one or more corrective spinal metrics of the spine of the patient to achieve the post-operative anatomy of the spine, […] ((Kontaxis et al., [0056]-[0057], [0124]) (for all selected implants, locations or procedures for the patient specific joint surgery. In this way, information obtained from prior implant selections or proposed surgical locations may be further refined or altered in order to provide a range of suitable surgical options for consideration based on patient specific conditions and expected or desired post-surgical activities of daily living. Finally, step 140 reflects the output of the method as an assessment of all tested implants and surgical locations. There is a summary output that includes the ranking, scoring, comparison graphics for all selected or evaluated implants, locations or procedures; to design components produced during the additive manufacturing process in support of the patient specific joint surgery described herein)).
Kontaxis et al fails to explicitly teach, but Shelton IV et al. teaches the claimed:
obtaining reimbursement information for one or more patient-specific spinal implants based on diagnosis data, procedural data, or pathology data of the patient in the patient-specific interactive surgical plan; assigning at least one medical reimbursement code to the one or more patient-specific spinal implants based on the reimbursement information ((Shelton IV et al., [0568],, [0569], [0573]) (The global analyses be useful for changes in best-practices, new reimbursement codes, etc.; Analysis by the edge cloud system may compare specific billing to one of more of patient outcomes, most successful reimbursement and reimbursement code usage, and/or best starting point procedures to be most successful for reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc.));
[…] quantify for medical reimbursement based on one or more parameters of the one or more patient-specific spinal implants matching the reimbursement information ((Shelton IV et al., [0573]) (a procedure's reimbursement rate may be used with the outcomes data to instruct surgical procedure plan(s) and/or recovery plan(s). In an example, reimbursement data from billing system 43668 (e.g., a system from data systems 43610 through 43612 in FIG. 36) and outcomes data from surgical hub #1 and surgical hub #2 in OR 43662 and OR 43664, respectively, may be balanced to identify value-added treatments as a starting point for surgical procedure plan(s) and/or recovery plan(s))).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine analysis of reimbursement and most successful reimbursement codes compared to outcomes to identify and instruct surgical procedure plans as taught by Shelton IV et al. within the method and system preoperative planned surgery including designing implants as taught by Kontaxis et al. with the motivation of most successfully provide reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc. (Shelton IV et al. [0569]).
RE: Claim 19 (Currently Amended) Kontaxis et al. and Shelton IV et al. teach the claimed:
19. The non-transitory computer-readable medium of claim 16, wherein the patient-specific interactive surgical plan includes one or more regulatory indication values associated with a treatment provided by the one or more patient-specific spinal implants ((Kontaxis et al., [0130]) (Including digital models of components from manufactures listed below or digital models of the products listed below or of all selected products having regulatory approval)).
RE: Claim 20 Kontaxis et al. and Shelton IV et al. teach the claimed:
20. The non-transitory computer-readable medium of claim 16, wherein the operations further include: displaying a user inputted modification to the patient-specific interactive surgical plan; and dynamically updating at least one of regulatory approval or reimbursement information, wherein the updating is based on the user inputted modification ((Kontaxis et al., [0066]-[0067]) (there is a determination of whether to select a different prosthesis, manufacturer, model, size or further surgeon based input to modify location, size or other factors for the surgical procedure being evaluated. If the answer at 240 is "YES" then the process loops back to step to decision 205 for selecting a new prosthesis for testing and then method repeats for that additional prosthesis. If the answer at 240 is "NO" then the process continues to step 245. At step 245, there is an output of all of the patient specific assessments collected i.e. dynamically output based on surgeon input; Moreover, the output includes the impact on selected activity of daily living and standard clinical tests for all selected prosthesis manufacturer, models and sizes for each tested implantation site)).
Claims 2-3, 12-13, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2023/0048940 A1 (hereinafter “Kontaxis et al.”) in view of U.S. 2023/0023083 A1 (hereinafter “Shelton IV et al.”), and further in view of U.S. 2013/0006649 A1 (hereinafter “Rangadass et al.”).
RE: Claim 2 (Currently Amended) Kontaxis et al. and Shelton IV et al. teach the claimed:
2. The computer-implemented method of claim 1, wherein the surgical planning platform is configured to […] generate the virtual three-dimensional model representing the patient's anatomy of the patient (Kontaxis et al., [0126]) (The first step is the creation or access to a digital/virtual model library containing electronic models of various components, implants, tools, guides, kits and the like for use in the system. Next, the second step, is to collect patient imaging data (810). Thereafter, the patient imaging data is provided to the patient imaging/model module (815). Next, the patient imaging data is combined with implant data (820) in the surgical planning/modification and assessment module));
manipulate the virtual three-dimensional model to generate a first surgical plan […]; and manipulate the virtual three-dimensional model to generate a second surgical plan […] ((Kontaxis et al., [0126], [0127]) (the model is manipulated to provide a variety of simulations and testing corresponding to activities of daily living and other clinical testing as desired. The next step 835 is to report all results of the assessment module to the total joint surgical planning and evaluation system. An output of all testing simulations performed is provided as a scorecard or assessment tool; the output of the planning and evaluation planning system enables a user to compare side by side the various assessment criteria for a specific patient under the prioritized selection criteria for that patient. In this way, a surgeon may have increased confidence in the comparison of different procedures as well as implants-independent of manufacturer in order to asses on a patient specific basis whether an anatomic or reverse shoulder procedure would best provide the desired outcome based on the factors discussed herein)).
Kontaxis et al. fails to explicitly teach, but Shelton IV et al. teaches the claimed:
[…] to generate a first surgical plan that qualifies for reimbursement under the first medical reimbursement code […]; and […] to generate a second surgical plan that qualifies for reimbursement under the second medical reimbursement code […] ((Shelton IV et al., [0568], [0569]) (The global analyses be useful for changes in best-practices, new reimbursement codes, etc.; Analysis by the edge cloud system may compare specific billing to one of more of patient outcomes, most successful reimbursement and reimbursement code usage, and/or best starting point procedures to be most successful for reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc.; a procedure's reimbursement rate may be used with the outcomes data to instruct surgical procedure plan(s) and/or recovery plan(s). In an example, reimbursement data from billing system 43668 (e.g., a system from data systems 43610 through 43612 in FIG. 36) and outcomes data from surgical hub #1 and surgical hub #2 in OR 43662 and OR 43664, respectively, may be balanced to identify value-added treatments as a starting point for surgical procedure plan(s) and/or recovery plan(s))).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine analysis of reimbursement and most successful reimbursement codes compared to outcomes to identify and instruct surgical procedure plans as taught by Shelton IV et al. within the method and system preoperative planned surgery including designing implants as taught by Kontaxis et al. with the motivation of most successfully provide reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc. (Shelton IV et al. [0569]).
Kontaxis et al. and Shelton IV et al. fail to explicitly teach, but Rangadass et al. teaches the claimed:
store, via a regulatory and reimbursement manager, a first medical reimbursement code and a second medical reimbursement code in a medical code database ((Rangadass et al., [0048]) (The decision support system comprises several tables enabling users to analyze and rank pathway options according to financial and clinical risk. A charge master is a table to standard expected costs per region per ICD-9/CPT. A fee schedule is a table of standard expected reimbursements per payer per ICD-9/CPT per region for eligible patients)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the clinical decision support system for clinical pathways by analyzing financial and clinical risk utilizing a table of expected cost per ICD/CPT code and expected reimbursements per ICD/CPT code as taught by Rangadass et al. within the method and system preoperative planned surgery including designing implants as taught by Kontaxis et al. and the analysis of reimbursement and most successful reimbursement codes compared to outcomes to identify and instruct surgical procedure plans as taught by Shelton IV et al. with the motivation of providing quality, efficient, and cost effective patient care for appropriate patients (Rangadass et al. [0007]).
RE: Claim 3 Kontaxis et al. and Shelton IV et al. teach the claimed:
3. The computer-implemented method of claim 2, further comprising: displaying a comparison of the first and second surgical plans, […] and a predicted patient outcome comparison between the first and second surgical plans ((Kontaxis et al., [0126], [0127]) (the model is manipulated to provide a variety of simulations and testing corresponding to activities of daily living and other clinical testing as desired. The next step 835 is to report all results of the assessment module to the total joint surgical planning and evaluation system. An output of all testing simulations performed is provided as a scorecard or assessment tool; the output of the planning and evaluation planning system enables a user to compare side by side the various assessment criteria for a specific patient under the prioritized selection criteria for that patient. In this way, a surgeon may have increased confidence in the comparison of different procedures as well as implants-independent of manufacturer in order to asses on a patient specific basis whether an anatomic or reverse shoulder procedure would best provide the desired outcome based on the factors discussed herein)).
Kontaxis et al. fails to explicitly teach, but Shelton IV et al. teaches the claimed:
wherein the comparison includes a reimbursement comparison between the first and second surgical plans; ((Shelton IV et al., [0569]) (Analysis by the edge cloud system may compare specific billing to one of more of patient outcomes, most successful reimbursement and reimbursement code usage, and/or best starting point procedures to be most successful for reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc.))
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine analysis of reimbursement and most successful reimbursement codes compared to outcomes to identify and instruct surgical procedure plans as taught by Shelton IV et al. within the method and system preoperative planned surgery including designing implants as taught by Kontaxis et al. and the clinical decision support system for clinical pathways by analyzing financial and clinical risk utilizing a table of expected cost per ICD/CPT code and expected reimbursements per ICD/CPT code as taught by Rangadass et al. with the motivation of most successfully provide reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc. (Shelton IV et al. [0569]).
RE: Claim 12 (Currently Amended) Kontaxis et al. and Shelton IV et al. teach the claimed:
12. The system of claim 11, wherein the process further includes: […] generating the virtual three-dimensional model representing the patient's anatomy (Kontaxis et al., [0126]) (The first step is the creation or access to a digital/virtual model library containing electronic models of various components, implants, tools, guides, kits and the like for use in the system. Next, the second step, is to collect patient imaging data (810). Thereafter, the patient imaging data is provided to the patient imaging/model module (815). Next, the patient imaging data is combined with implant data (820) in the surgical planning/modification and assessment module));
manipulating the virtual three-dimensional model to generate a first surgical plan […]; and manipulating the virtual three-dimensional model to generate a second surgical plan […] ((Kontaxis et al., [0126], [0127]) (the model is manipulated to provide a variety of simulations and testing corresponding to activities of daily living and other clinical testing as desired. The next step 835 is to report all results of the assessment module to the total joint surgical planning and evaluation system. An output of all testing simulations performed is provided as a scorecard or assessment tool; the output of the planning and evaluation planning system enables a user to compare side by side the various assessment criteria for a specific patient under the prioritized selection criteria for that patient. In this way, a surgeon may have increased confidence in the comparison of different procedures as well as implants-independent of manufacturer in order to asses on a patient specific basis whether an anatomic or reverse shoulder procedure would best provide the desired outcome based on the factors discussed herein)).
Kontaxis et al. fails to explicitly teach, but Shelton IV et al. teaches the claimed:
[…] to generate a first surgical plan that qualifies for reimbursement under the first medical reimbursement code […]; and […] to generate a second surgical plan that qualifies for reimbursement under the second medical reimbursement code […] ((Shelton IV et al., [0568], [0569]) (The global analyses be useful for changes in best-practices, new reimbursement codes, etc.; Analysis by the edge cloud system may compare specific billing to one of more of patient outcomes, most successful reimbursement and reimbursement code usage, and/or best starting point procedures to be most successful for reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc.; a procedure's reimbursement rate may be used with the outcomes data to instruct surgical procedure plan(s) and/or recovery plan(s). In an example, reimbursement data from billing system 43668 (e.g., a system from data systems 43610 through 43612 in FIG. 36) and outcomes data from surgical hub #1 and surgical hub #2 in OR 43662 and OR 43664, respectively, may be balanced to identify value-added treatments as a starting point for surgical procedure plan(s) and/or recovery plan(s))).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine analysis of reimbursement and most successful reimbursement codes compared to outcomes to identify and instruct surgical procedure plans as taught by Shelton IV et al. within the method and system preoperative planned surgery including designing implants as taught by Kontaxis et al. with the motivation of most successfully provide reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc. (Shelton IV et al. [0569]).
Kontaxis et al. and Shelton IV et al. fail to explicitly teach, but Rangadass et al. teaches the claimed:
storing, via a regulatory and reimbursement manager, a first medical reimbursement code and a second medical reimbursement code in a medical code database ((Rangadass et al., [0048]) (The decision support system comprises several tables enabling users to analyze and rank pathway options according to financial and clinical risk. A charge master is a table to standard expected costs per region per ICD-9/CPT. A fee schedule is a table of standard expected reimbursements per payer per ICD-9/CPT per region for eligible patients)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the clinical decision support system for clinical pathways by analyzing financial and clinical risk utilizing a table of expected cost per ICD/CPT code and expected reimbursements per ICD/CPT code as taught by Rangadass et al. within the method and system preoperative planned surgery including designing implants as taught by Kontaxis et al. and the analysis of reimbursement and most successful reimbursement codes compared to outcomes to identify and instruct surgical procedure plans as taught by Shelton IV et al. with the motivation of providing quality, efficient, and cost effective patient care for appropriate patients (Rangadass et al. [0007]).
RE: Claim 13 Kontaxis et al. and Shelton IV et al. teach the claimed:
13. The system of claim 12, wherein the process further includes: displaying a comparison of the first and second surgical plans, […]; and a predicted patient outcome comparison between the first and second surgical plans ((Kontaxis et al., [0126], [0127]) (the model is manipulated to provide a variety of simulations and testing corresponding to activities of daily living and other clinical testing as desired. The next step 835 is to report all results of the assessment module to the total joint surgical planning and evaluation system. An output of all testing simulations performed is provided as a scorecard or assessment tool; the output of the planning and evaluation planning system enables a user to compare side by side the various assessment criteria for a specific patient under the prioritized selection criteria for that patient. In this way, a surgeon may have increased confidence in the comparison of different procedures as well as implants-independent of manufacturer in order to asses on a patient specific basis whether an anatomic or reverse shoulder procedure would best provide the desired outcome based on the factors discussed herein)).
Kontaxis et al. fails to explicitly teach, but Shelton IV et al. teaches the claimed:
wherein the comparison includes a reimbursement comparison between the first and second surgical plans; ((Shelton IV et al., [0569]) (Analysis by the edge cloud system may compare specific billing to one of more of patient outcomes, most successful reimbursement and reimbursement code usage, and/or best starting point procedures to be most successful for reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc.)) One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine analysis of reimbursement and most successful reimbursement codes compared to outcomes to identify and instruct surgical procedure plans as taught by Shelton IV et al. within the method and system preoperative planned surgery including designing implants as taught by Kontaxis et al. and the clinical decision support system for clinical pathways by analyzing financial and clinical risk utilizing a table of expected cost per ICD/CPT code and expected reimbursements per ICD/CPT code as taught by Rangadass et al. with the motivation of most successfully provide reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc. (Shelton IV et al. [0569]).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine analysis of reimbursement and most successful reimbursement codes compared to outcomes to identify and instruct surgical procedure plans as taught by Shelton IV et al. within the method and system preoperative planned surgery including designing implants as taught by Kontaxis et al. and the clinical decision support system for clinical pathways by analyzing financial and clinical risk utilizing a table of expected cost per ICD/CPT code and expected reimbursements per ICD/CPT code as taught by Rangadass et al. with the motivation of most successfully provide reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc. (Shelton IV et al. [0569]).
RE: Claim 17 (Currently Amended) Kontaxis et al. and Shelton IV et al. teach the claimed:
17. The non-transitory computer-readable medium of claim 16, wherein the operations further include: […] generating the virtual three-dimensional model representing the patient's anatomy (Kontaxis et al., [0126]) (The first step is the creation or access to a digital/virtual model library containing electronic models of various components, implants, tools, guides, kits and the like for use in the system. Next, the second step, is to collect patient imaging data (810). Thereafter, the patient imaging data is provided to the patient imaging/model module (815). Next, the patient imaging data is combined with implant data (820) in the surgical planning/modification and assessment module));
manipulating the virtual three-dimensional model to generate a first surgical plan […]; and manipulating the virtual three-dimensional model to generate a second surgical plan […] ((Kontaxis et al., [0126], [0127]) (the model is manipulated to provide a variety of simulations and testing corresponding to activities of daily living and other clinical testing as desired. The next step 835 is to report all results of the assessment module to the total joint surgical planning and evaluation system. An output of all testing simulations performed is provided as a scorecard or assessment tool; the output of the planning and evaluation planning system enables a user to compare side by side the various assessment criteria for a specific patient under the prioritized selection criteria for that patient. In this way, a surgeon may have increased confidence in the comparison of different procedures as well as implants-independent of manufacturer in order to asses on a patient specific basis whether an anatomic or reverse shoulder procedure would best provide the desired outcome based on the factors discussed herein)).
Kontaxis et al. fails to explicitly teach, but Shelton IV et al. teaches the claimed:
[…] to generate a first surgical plan that qualifies for reimbursement under the first medical reimbursement code […]; and […] to generate a second surgical plan that qualifies for reimbursement under the second medical reimbursement code […] Shelton IV et al., [0568], [0569]) (The global analyses be useful for changes in best-practices, new reimbursement codes, etc.; Analysis by the edge cloud system may compare specific billing to one of more of patient outcomes, most successful reimbursement and reimbursement code usage, and/or best starting point procedures to be most successful for reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc.; a procedure's reimbursement rate may be used with the outcomes data to instruct surgical procedure plan(s) and/or recovery plan(s). In an example, reimbursement data from billing system 43668 (e.g., a system from data systems 43610 through 43612 in FIG. 36) and outcomes data from surgical hub #1 and surgical hub #2 in OR 43662 and OR 43664, respectively, may be balanced to identify value-added treatments as a starting point for surgical procedure plan(s) and/or recovery plan(s))).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine analysis of reimbursement and most successful reimbursement codes compared to outcomes to identify and instruct surgical procedure plans as taught by Shelton IV et al. within the method and system preoperative planned surgery including designing implants as taught by Kontaxis et al. with the motivation of most successfully provide reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc. (Shelton IV et al. [0569]).
Kontaxis et al. and Shelton IV et al. fail to explicitly teach, but Rangadass et al. teaches the claimed:
storing, via a regulatory and reimbursement manager, a first medical reimbursement code and a second medical reimbursement code in a medical code database ((Rangadass et al., [0048]) (The decision support system comprises several tables enabling users to analyze and rank pathway options according to financial and clinical risk. A charge master is a table to standard expected costs per region per ICD-9/CPT. A fee schedule is a table of standard expected reimbursements per payer per ICD-9/CPT per region for eligible patients)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the clinical decision support system for clinical pathways by analyzing financial and clinical risk utilizing a table of expected cost per ICD/CPT code and expected reimbursements per ICD/CPT code as taught by Rangadass et al. within the method and system preoperative planned surgery including designing implants as taught by Kontaxis et al. and the analysis of reimbursement and most successful reimbursement codes compared to outcomes to identify and instruct surgical procedure plans as taught by Shelton IV et al. with the motivation of providing quality, efficient, and cost effective patient care for appropriate patients (Rangadass et al. [0007]).
RE: Claim 18 Kontaxis et al. and Shelton IV et al. teach the claimed:
18. The non-transitory computer-readable medium of claim 17, wherein the operations further include: displaying a comparison of the first and second surgical plans, […]; and a predicted patient outcome comparison between the first and second surgical plans ((Kontaxis et al., [0126], [0127]) (the model is manipulated to provide a variety of simulations and testing corresponding to activities of daily living and other clinical testing as desired. The next step 835 is to report all results of the assessment module to the total joint surgical planning and evaluation system. An output of all testing simulations performed is provided as a scorecard or assessment tool; the output of the planning and evaluation planning system enables a user to compare side by side the various assessment criteria for a specific patient under the prioritized selection criteria for that patient. In this way, a surgeon may have increased confidence in the comparison of different procedures as well as implants-independent of manufacturer in order to asses on a patient specific basis whether an anatomic or reverse shoulder procedure would best provide the desired outcome based on the factors discussed herein)).
Kontaxis et al. fails to explicitly teach, but Shelton IV et al. teaches the claimed:
wherein the comparison includes a reimbursement comparison between the first and second surgical plans; ((Shelton IV et al., [0569]) (Analysis by the edge cloud system may compare specific billing to one of more of patient outcomes, most successful reimbursement and reimbursement code usage, and/or best starting point procedures to be most successful for reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc.)) One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine analysis of reimbursement and most successful reimbursement codes compared to outcomes to identify and instruct surgical procedure plans as taught by Shelton IV et al. within the method and system preoperative planned surgery including designing implants as taught by Kontaxis et al. and the clinical decision support system for clinical pathways by analyzing financial and clinical risk utilizing a table of expected cost per ICD/CPT code and expected reimbursements per ICD/CPT code as taught by Rangadass et al. with the motivation of most successfully provide reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc. (Shelton IV et al. [0569]).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine analysis of reimbursement and most successful reimbursement codes compared to outcomes to identify and instruct surgical procedure plans as taught by Shelton IV et al. within the method and system preoperative planned surgery including designing implants as taught by Kontaxis et al. and the clinical decision support system for clinical pathways by analyzing financial and clinical risk utilizing a table of expected cost per ICD/CPT code and expected reimbursements per ICD/CPT code as taught by Rangadass et al. with the motivation of most successfully provide reimbursement with lowest cost, staffing skill needs, staffing utilization and OR usage, etc. (Shelton IV et al. [0569]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2023/0048940 A1 (hereinafter “Kontaxis et al.”) in view of U.S. 2023/0023083 A1 (hereinafter “Shelton IV et al.”), and further in view of U.S. 2021/0304265 A1 (hereinafter “Yedlarajaiah et al.”).
RE: Claim 7 (Currently Amended) Kontaxis et al. and Shelton IV et al. teach the claimed:
7. The computer-implemented method of claim 1, further comprising:[…]; displaying verification that treatment using the one or more patient-specific spinal implants is approved by a government regulatory agency ((Kontaxis et al., [0130]) (the digital/virtual model data includes data of products from manufactures as well as digital models of FDA approved devices)); and
displaying pricing based on a new technology add-on payment and/or diagnosis-related group payment.
Kontaxis et al. and Shelton IV et al. fail to explicitly teach, but Charlson et al. teaches the claimed:
verifying accuracy of matching of the at least one medical reimbursement code to the one or more patient-specific spinal implants based on at least one predetermined processing rule prior to transmitting a reimbursement request for treatment to a medical reimbursement processor ((Yedlarajaiah et al., [0028]) (filtering options to select to view/analyze summaries and details associated with the accuracy of various estimated values versus actual values associated with: … matching and/or non-matching Current Procedural Terminology (CPT) codes (e.g., matched between an estimate 116, a claim 118, and/or a remittance 124), one or more procedure codes))
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine view/analyze the accuracy of matching and/or non-matching CPT codes by Yedlarajaiah et al. within the method and system preoperative planned surgery including designing implants as taught by Kontaxis et al. and the analysis of reimbursement and most successful reimbursement codes compared to outcomes to identify and instruct surgical procedure plans as taught by Shelton IV et al. with the motivation of improving the quality of care available to patients by improving the accuracy of individual systems for services billed to patients (Yedlarajaiah et al. [0002]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2023/0048940 A1 (hereinafter “Kontaxis et al.”) in view of U.S. 2023/0023083 A1 (hereinafter “Shelton IV et al.”), and further in view of Manz, C. R., Bekelman, J. E., & Doshi, J. A. (2020). The Changing Characteristics of Technologies Covered by Medicare's New Technology Add-on Payment Program. JAMA network open, 3(8), e2012569 (hereinafter “Manz et al.”).
RE: Claim 10 Kontaxis et al. and Shelton IV et al. teach the claimed:
10. The computer-implemented method of claim 1, further comprising: coding one or more patient-specific devices for multiple coded reimbursements, wherein the multiple coded reimbursements include: a new technology add-on reimbursement; and a diagnoses-related groups reimbursement ((Manz et al. pgs. 1, 3) (Medicare’s inpatient prospective payment system pays for inpatient hospitalizations according to diagnosis related groups (DRGs), with reimbursement based on average costs for each DRG in the previous 2 years; Device approvals may also increase because of recent policy changes loosening NTAP criteria for Food and Drug Administration–designated “breakthrough devices.”)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the utilization of Medicare’s payment system according to diagnosis related groups and device approvals according to NTAP criteria as taught by Manz et al. within the method and system preoperative planned surgery including designing implants as taught by Kontaxis et al. and the analysis of reimbursement and most successful reimbursement codes compared to outcomes to identify and instruct surgical procedure plans as taught by Shelton IV et al. with the motivation of providing reimbursement for new technologies through bridge payments for the 2 to 3 years it takes for DRG to recalibrate (Manz et al. at pg. 1).
Response to Arguments
Applicant's arguments filed 02/18/2026 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed herein below in the order in which they appear in the response filed on 02/18/2026.
In the remarks, Applicant argues in substance that:
Regarding the 112(b) rejection of claims 1-20, Applicant argues the amendments to the claims overcome the prior rejection;
Regarding the 101 rejection of claims 1-20, Applicant argues that the claims recite patient eligible subject matter through an integration into a practical application; and
Regarding the 103 rejection of claims 1-20, applicant respectfully submits that the combined disclosures of Kulkarni et al. and Ivanoff et al. for claims 1-7, 9-16, and 18-20 and the additional disclosure of Hadad for claims 8 and 17, respectively, do not teach or suggest a method as recited in amended claim 1 that includes in response to determining that a user device is associated with a consumer, tailoring a dashboard user interface for the consumer, including populating the dashboard with a link to a user interface that allows the consumer to set up and activate a transaction management plan upon actuation of the link based on the recovery probably having a first score.
In response to Applicant’s argument that (a) regarding the 112(b) rejection of claims 1-20, Examiner is persuaded in light of the current amendments and has withdrawn the prior 112(b) rejection.
In response to Applicant’s argument that (b) regarding the 101 rejection of claims 1-20, Examiner respectfully disagrees.
Applicant argues that the claims process is an improvement in a technical field through a technical process to design an implant for a spinal deformity of the patient such that the technical improvement signifies that the claims are not directed to an abstract idea. Examiner respectfully disagrees and submits that the claims merely recite the additional elements (e.g. processors, memory, and a graphical user interface) as generic computer components used as tools under their ordinary capacity for performing the abstract idea for designing patient-specific spinal implants. This is distinguishable from Example 42, that exemplifies a claim that provides a technical solution to a technical problem (i.e. real-time data transmission from remote locations and different hardware through converting data into a standardized format regardless of the format it was received), whereas the instant claims do not recite a technical solution to an underlying technical problem. Further, the instant claims are distinguishable from Example 49, that exemplifies integration into a practical application from a particular treatment for a particular disease. The instant claims recite a broad class of potential diseases (spinal deformity) and a broad class of potential treatments (spinal implants), whereas Example 49 is directed to a particular treatment (Compound X) to a particular disease (identifying the glaucoma patient as at high risk of post-implantation inflammation).
Applicant argues that the claim effects a transformation or reduction of a particular article to a different state or thing because the claims recite specific steps for obtaining certain types of data and transforming this data to design “one or more patient-specific spinal implants,” however, the claims do not recite any meaningful data “transformation” beyond mere data analysis as part of the abstract idea.
Applicant argues under Step 2B that the claims cannot reasonable be performed in the mind and when viewed as a whole recite significantly more than the abstract idea. Examiner respectfully disagrees and submits that the additional elements of the claim amount to using generic computer components in their ordinary capacity as tools for performing the abstract idea. See MPEP 2106.05(f). Accordingly, the additional elements of the claim do not recite significantly more than the abstract idea.
Accordingly, the 101 rejection of claims 1-20 is maintained.
In response to Applicant’s argument (c) regarding the 103 rejection of claims 1-20, Examiner respectfully disagrees.
Upon further search and consideration, as noted in the Interview dated 02/05/2026 wherein no agreement was reached (See Interview Summary 02/09/2026), previously cited reference Kontaxis et al. in view of previously cited Shelton IV et al. teach each limitation of the independent claims. Kontaxis et al. discloses that any joint, including the spine, as applied to the taught exemplary methods of the shoulder and the designing of surgical implants thereof. See Kontaxis et al. at [0049].
Accordingly, the 103 rejection of claims 1-20 is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. 2022/0309592 A1 teaches determining determine a recommended equivalent code for requesting reimbursement [0259];
U.S. 11,931,107 B1 teaches creating a 3D model based on a plurality of 2D medical images containing a patient anatomy to facilitate a surgical procedure (Abstract); and
U.S. 10,130,378 B2 teaches generating patient specific instruments for use as surgical guides utilizing 3D models of a selected patient implant via a graphical user interface (Abstract).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/A.M.B./Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682
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