DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-10, 25-26, 28-31, and 33-39 are presented for examination based on the amended claims in the application filed on January 27, 2026. Claims 11-24, 27, and 32 have been cancelled by the applicant.
Claims 1-10, 25-26, 28-31, and 33-39 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to judicial exception, an abstract idea, it has not been integrated into practical application and the claims further do not recite significantly more than the judicial exception.
Claims 1-6, 8-9, 25, 28-30, 33-39 are rejected under 35 U.S.C. § 103 as being unpatentable over US 2020/0093542 A1 Arramon et al. [herein “Arramon”] in view of US 2017/0252107 A1 Turner, Alex et al. [herein “Turner”].
Claims 7 and 10 are rejected under 35 U.S.C. § 103 as being unpatentable over Arramon and Turner as applied to claim 1 above, and further in view of US 8,613,771 B2 Hansell et al. [herein “Hansell”].
Claims 26 and 31 are rejected under 35 U.S.C. § 103 as being unpatentable over Arramon and Turner as applied to claim 1 above, and further in view of US 2022/0249168 A1 Besier et al. [herein “Besier”].
This action is made Non-Final.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 27, 2026 has been entered.
Response to Amendment
The amendment filed January 27, 2026 has been entered. Claims 1-10, 25-26, 28-31, and 34-39 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 112(a) rejection previously set forth in the Final Office Action mailed October 27, 2025.
Claim Objections
Claim 37 is objected to because of the following informality: claim 37, which cites “The method” in Ln. 1, is improper because there has been no previous recitation of “The method”. If claim 37 were to be written to be dependent on claim 1, then the objection would be overcome.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 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 1-10, 25-26, 28-31, and 33-39 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to judicial exception, an abstract idea, it has not been integrated into practical application and the claims further do not recite significantly more than the judicial exception. Examiner has evaluated the claims under the framework provided in the 2019 Patent Eligibility Guidance published in the Federal Register 01/07/2019 and has provided such analysis below.
Step 1:
Claims 1-10, 25-26, 28, and 35-37 are directed to a method and fall within the statutory category of a process; claims 29-31, 33, and 38 are directed to a non-transitory computer-readable medium and fall within the statutory category of articles of manufacture; and claims 34 and 39 are directed to a system and fall within the statutory category of a machine. Therefore, “Are the claims to a process, machine, manufacture or composition of matter?” Yes.
In order to evaluate the Step 2A inquiry “Is the claim directed to a law of nature, a natural phenomenon or an abstract idea?” we must determine, at Step 2A Prong 1, whether the claim recites a law of nature, a natural phenomenon or an abstract idea and further whether the claim recites additional elements that integrate the judicial exception into a practical application.
Step 2A Prong 1:
Claims 1, 29, and 34: They recite the limitations of:
1) “determining, based at least in part on the interactive virtual model showing the target post-surgical anatomical configuration, (1) one or more target post-surgical kinematic parameters for the one or more regions of the patient's spine associated with the target post-surgical anatomical configuration, the one or more target post-surgical kinematic parameters including a target post-surgical type of motion and/or degree of motion”,
2) “and (2) one or more target post-surgical centers of rotation for the one or more regions of the patient's spine associated with the target post-surgical anatomical configuration”,
3) “designing the patient-specific arthroplasty device based on the target post-surgical anatomical configuration, the target post-surgical kinematic parameters, and the target post-surgical centers of rotation”, and
4) “generating a patient-specific treatment plan, wherein the patient-specific treatment plan includes (a) a plurality of images of the target post-surgical anatomical configuration taken from the interactive virtual model, and (b) the target postsurgical kinematic parameters and the target post-surgical centers of rotation”,
5) “in response to receiving user approval of the target post-surgical centers of rotation, generating computer-executable fabrication instructions for fabricating the patient-specific arthroplasty device” as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, these limitations can be conducted as the following:
a) a person can mentally determine or draw with pen and paper a desired degree of motion of the patient’s spine regions that would be obtained after a surgery was implemented and while viewing the desired configuration by comparing the patient’s current degree of motion with a reference of an optimal spine region’s degree of motion for a similar patient,
b) a person can mentally determine or draw with pen and paper a desired center of rotation for the patient’s spine regions that would be obtained after a surgery was implemented and while viewing the desired configuration by comparing the patient’s current center of rotation with a reference of an optimal spine region center of rotation for a similar patient,
c) a person can mentally create or draw with pen and paper a device by selecting and combining various components and materials that will yield the desired anatomical configuration, kinematic parameters, and the centers of rotation with a successful surgery,
d) a person can mentally create or draw with pen and paper a treatment plan for obtaining the desired configuration of the patient’s spine regions after a surgery by drawing the determined desired configuration of the patient’s spine regions after a surgery and including the desired degree of motion and desired center of rotation for the patient’s spine regions, and
e) a person can mentally create or draw with pen and paper code that will be executed by a computer to manufacture the device after getting confirmation that the model of the device is accurate.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recite an abstract idea under Prong I step 2A.
Therefore, yes, claims recite judicial exceptions. The claim has been identified to recite judicial exceptions, Step 2A Prong 2 will evaluate whether the claim is directed to the judicial exception.
Step 2A Prong 2:
Claims 1, 29, and 34: The judicial exception is not integrated into a practical application. In particular, the claim recites the following additional element “obtaining patient data associated with one or more regions of a patient's spine”, “preoperatively receiving one or more manipulations from a user to manipulate a spatial relationship between one or more of the individual vertebrae within the interactive model to design a target post-surgical anatomical configuration for the one or more regions”, and “sending the patient-specific treatment plan to a user device for display for user review, modification, approval, and/or rejection of the target post-surgical centers of rotation” and which are merely a recitation of insignificant extra-solution data gathering and data outputting activities (see MPEP § 2106.05(g)) which does not integrate a judicial exception into practical application. The insignificant extra-solution activities are further addressed below under step 2B as also being Well-Understood, Routine, and Conventional (WURC). Furthermore, the additional element recitations of “generating an interactive virtual model of the one or more regions of the patient's spine based on the patient data, the interactive virtual model depicting (a) individual vertebrae within the one or more regions of the patient's spine, and (b) centers of rotation for corresponding vertebral segments of the patient's spine”, “A non-transitory computer-readable medium storing instructions that, when executed by a computing system, cause the computing system to perform operations for designing a patient-specific arthroplasty device” and “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” is merely a recitation of generic computing components and functions being used as a tool to implement the judicial exception (see MPEP § 2106.05(f)) which does not integrate a judicial exception into practical application.
Therefore, “Do the claims recite additional elements that integrate the judicial exception into a practical application?” No, these additional elements do not integrate the abstract idea into a practical application and they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
After having evaluated the inquires set forth in Steps 2A Prong 1 and 2, it has been concluded that claims 1, 29, and 34 not only recite a judicial exception but that the claims are directed to the judicial exception as the judicial exception has not been integrated into practical application.
Step 2B:
Claims 1, 29, and 34: The claims do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than generic computing components and functions which do not amount to significantly more than the abstract idea. Further, the insignificant extra-solution data gathering, record update, and data transmission activities are also Well-Understood, Routine and Conventional (see MPEP § 2106.05(d)(II), “The courts have recognized the following computer functions as well understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. i. Receiving or transmitting data over a network, ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory”).
Therefore, “Do the claims recite additional elements that amount to significantly more than the judicial exception?” No, the additional elements, alone or in combination, do not amount to significantly more than the judicial exception. Having concluded the analysis within the provided framework, Claims 1, 29, and 34 do not recite patent eligible subject matter under 35 U.S.C. § 101.
Regarding claim 2, it recites an additional limitation of “wherein the patient-specific arthroplasty device comprises: a first end-plate having a first patient-specific topography, a second end-plate having a second patient-specific topography, and a mobility element disposed between the first end-plate and the second end-plate, wherein the mobility element is designed to comply with the one or more target post-surgical kinematic parameters and to achieve the target post-surgical center of rotation when the patient-specific arthroplasty device is implanted in the patient's spine” as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally create or draw with pen and paper a device by selecting and combining various components and materials to form a first plate to match the topography of a lower portion of an upper vertebral body, a second plate to match the topography of an upper portion of a lower vertebral body, and a moveable structure between the first and second plates that will achieve the desired degree of motion and the center of rotation that would be obtained after the device is implanted during a successful surgery.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding claim 3, it recites an additional limitation of “wherein the mobility element is designed for allowing (1) rotation of the first end-plate and the second end-plate relative to each other, and (2) translation of the first end-plate and the second end-plate relative to each other” as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally create or draw with pen and paper a moveable structure in the device by selecting, combining, and shaping various components and materials that will achieve the desired rotation and translation of the first and second plate with respect to each other that would be obtained after the device is implanted during a successful surgery.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding claim 4, it recites an additional limitation of “wherein the mobility element is designed for allowing six degrees of freedom of movement between the first end-plate and the second end-plate” as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally create or draw with pen and paper a moveable structure in the device by selecting, combining, and shaping various components and materials that will achieve the motion the first and second plate with respect to each other in the sagittal, conormal, and transverse plans that would be obtained after the device is implanted during a successful surgery.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding claim 5, it recites an additional element recitation of “wherein the patient data includes image data depicting a native anatomical configuration of the one or more regions of the patient's spine” is merely an insignificant extra-solution data gathering activity (see MPEP § 2106.05(g)) which does not integrate a judicial exception into practical application. Further, the insignificant extra-solution data gathering, record update, and data transmission activities are also Well-Understood, Routine and Conventional (see MPEP § 2106.05(d)(II), “The courts have recognized the following computer functions as well understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. i. Receiving or transmitting data over a network, ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory”). Further, this claim does not recite any further additional elements and for the same reasons as above with regard to integration into practical application and whether additional element amounts to significantly more, this claim also fails both Step 2A prong 2, thus this claim is directed to the judicial exception as it has not been integrated into practical application, and fails Step 2B as not amounting to significantly more. Therefore, claim 5 does not recite patent eligible subject matter under 35 U.S.C. § 101.
Regarding claim 6, it recites an additional element recitation of “wherein the patient data includes kinematic data associated with the one or more regions of a patient's spine, wherein the kinematic data includes values for one or more kinematic parameters” is merely an insignificant extra-solution data gathering activity (see MPEP § 2106.05(g)) which does not integrate a judicial exception into practical application. Further, the insignificant extra-solution data gathering, record update, and data transmission activities are also Well-Understood, Routine and Conventional (see MPEP § 2106.05(d)(II), “The courts have recognized the following computer functions as well understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. i. Receiving or transmitting data over a network, ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory”). Further, this claim does not recite any further additional elements and for the same reasons as above with regard to integration into practical application and whether additional element amounts to significantly more, this claim also fails both Step 2A prong 2, thus this claim is directed to the judicial exception as it has not been integrated into practical application, and fails Step 2B as not amounting to significantly more. Therefore, claim 6 does not recite patent eligible subject matter under 35 U.S.C. § 101.
Regarding claim 7, it recites an additional limitation of “wherein at least one of the target post-surgical centers of rotation is offset from a geometric centerpoint between adjacent vertebral bodies in the one or more regions of the patient's spine” as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally create or draw with pen and paper a desired center of rotation for the regions of a patient’s spine that is offset from a geometric centerpoint between adjacent vertebral bodies after a surgery by comparing the patient’s current center of rotation with a reference of an optimal spine region’s center of rotation for a similar patient.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding claim 8, it recites an additional limitation of “wherein the one or more target post-surgical centers of rotation are different than corresponding pre-surgical centers of rotation” as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally create or draw with pen and paper a desired center of rotation for the regions of a patient’s spine after a surgery by comparing the patient’s poor center of rotation of the spine regions prior to a surgery with a reference of an optimal spine region’s center of rotation for a similar patient to improve the center of rotation for a patient’s spine regions after the surgery.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding claim 9, it recites an additional limitation of “wherein the one or more target post-surgical kinematic parameters are different than corresponding pre-surgical kinematic parameters” as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally determine or draw with pen and paper a desired degree of motion for the regions of a patient’s spine after a surgery by comparing the patient’s poor current degree of motion of the spine regions prior to a surgery with a reference of an optimal spine region’s degree of motion for a similar patient to improve the degree of motion for a patient’s spine regions after the surgery.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding claim 10, it recites an additional limitation of “wherein the one or more target post-surgical kinematic parameters includes a target degree of rotation” as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally create or draw with pen and paper a desired degree of rotation for the regions of a patient’s spine after a surgery by comparing the patient’s poor current degree of rotation of the spine regions prior to a surgery with a reference of an optimal spine region’s degree of rotation for a similar patient to improve the degree of rotation for a patient’s spine regions after the surgery.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding claim 25 and 30, they recite an additional limitation of “calculating and displaying, during preoperatively manipulating the spatial relationship, changes in the centers of rotation for vertebral segments corresponding to the manipulations of the individual vertebrae” as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally determine and draw with pen and paper a difference in the centers of rotation for the regions of a patient’s spine by comparing the patient’s poor center of rotation of the spine regions prior to a surgery and subtracting with the desired center of rotation of the configuration of the patient’s spine regions that would be obtained after a surgery caused by the changing of the spacing between vertebrae.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Furthermore, regarding claims 25 and 30, they recite an additional limitation of “calculating, during preoperatively manipulating the spatial relationship, changes in the centers of rotation for vertebral segments corresponding to the manipulations of the individual vertebrae” as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation of mathematical evaluations. For example, calculating a difference in the centers of rotation for the regions of a patient’s spine can be accomplished by determining the average center of rotation between the patient’s poor center of rotation of the spine regions prior to a surgery and the desired center of rotation of the configuration of the patient’s spine regions that would be obtained after a surgery caused by the changing of the spacing between vertebrae (Para. 0108, “the software module can analyze one or more anatomical features/measurements in the image data and/or virtual model to define kinematic parameters, determine kinematic relationships, and/or estimate various kinematic parameters. Suitable anatomical features/measurements include, but are not limited to, the distance between anatomical landmarks, fiducials, vertebral spacing, vertebral orientation, abnormal bony growth, abnormal joint growth, joint inflammation, joint degeneration, tissue degeneration, stenosis, scar tissue, and combinations thereof…determining the optimal COR location is done by estimating an average COR for the different rotational motions.”).
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation of mathematic evaluations but for the recitation of generic computer components, then it falls within the “Mathematical Operation” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Furthermore, regarding claims 25 and 30, they recite additional element recitations of “automatically” and “in real time” is merely a recitation of generic computing components and functions being used as a tool to implement the judicial exception (see MPEP § 2106.05(f) and 2106.04(a)(2)(III)(D)) which does not integrate a judicial exception into practical application. Further, these claims do not recite any further additional elements and for the same reasons as above with regard to integration into practical application and whether additional element amounts to significantly more, these claims also fail both Step 2A prong 2, thus these claims are directed to the judicial exception as they have not been integrated into practical application, and fail Step 2B as not amounting to significantly more. Therefore, claims 25 and 30 do not recite patent eligible subject matter under 35 U.S.C. § 101.
Regarding claims 26 and 31, they recite an additional limitation of “wherein generating the patient-specific treatment plan includes using a machine learning model to generate one or more aspects of the patient-specific treatment plan” is merely a recitation of generic computing components and functions being used as a tool to implement the judicial exception (see MPEP § 2106.05(f)) which does not integrate a judicial exception into practical application. Further, these claims do not recite any further additional elements and for the same reasons as above with regard to integration into practical application and whether additional element amounts to significantly more, these claims also fail both Step 2A prong 2, thus these claims are directed to the judicial exception as they have not been integrated into practical application, and fail Step 2B as not amounting to significantly more. Therefore, claims 26 and 31 do not recite patent eligible subject matter under 35 U.S.C. § 101.
Regarding claims 28 and 33, they recite an additional element recitation of “manufacturing the patient-specific arthroplasty device by causing a manufacturing system to execute the computer-executable fabrication instructions” which is merely a recitation of instructions to apply the abstract idea as it only recites a mere idea of a solution or outcome and fails to recite details of how a solution to a problem is accomplished. For example, “manufacturing the patient-specific arthroplasty device by causing a manufacturing system to execute the computer-executable fabrication instructions” only recites the idea of manufacturing a device as there are no further limitations on specifically what the manufacture system is or what specific instructions are carried out by the manufacturing system for manufacturing the implant device; thus, amounting to mere instructions to apply it. Additionally, achieving an instance of a design after determining the design has also been found to be mere instructions to apply the abstract idea. Thus, the additional element is merely a recitation of instructions apply the abstract idea which does not integrate the judicial exception into a practical application (see MPEP § 2106.05(f), “(1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it"… Other examples where the courts have found the additional elements to be mere instructions to apply an exception, because they do no more than merely invoke computers or machinery as a tool to perform an existing process include: A method of assigning hair designs to balance head shape with a final step of using a tool (scissors) to cut the hair, In re Brown, 645 Fed. App'x 1014, 1017 (Fed. Cir. 2016)”). Further, these claims do not recite any further additional elements and for the same reasons as above with regard to integration into practical application and whether additional elements amount to significantly more, these claims also fail both Step 2A prong 2, thus the claims are directed to the judicial exception as they have not been integrated into practical application, and fail Step 2B as not amounting to significantly more. Therefore, claims 28 and 33 do not recite patent eligible subject matter under 35 U.S.C. § 101.
Regarding claims 35, 38, and 39, they recite an additional limitation of “wherein the target post-surgical kinematic parameters include: a range of motion, an angle of bend, an angle of rotation, flexion/extension arcs, and left or right bending arcs”, as drafted, is a process that, but for the recitation of generic computing components, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper. For example, a person can mentally create or draw with pen and paper a desired configuration of a patient’s spine after a surgery by comparing the patient’s poor spine configuration prior to a surgery with a reference of an optimal spine configuration for a similar patient to adjust the placement of a spinal implant that will improve the following parameters after the surgery: a range of motion, an angle of bend, an angle of rotation, flexion/extension arcs, and left or right bending arcs.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with pen and paper but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Prong I step 2A.
Regarding claim 36, it recites an additional element recitation of “wherein the one or more manipulations include changes to: a distance between two or more individual vertebrae, and an angular relationship between the two or more individual vertebrae” is merely an insignificant extra-solution data gathering activity (see MPEP § 2106.05(g)) which does not integrate a judicial exception into practical application. Further, the insignificant extra-solution data gathering, record update, and data transmission activities are also Well-Understood, Routine and Conventional (see MPEP § 2106.05(d)(II), “The courts have recognized the following computer functions as well understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. i. Receiving or transmitting data over a network, ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory”). Further, this claim does not recite any further additional elements and for the same reasons as above with regard to integration into practical application and whether additional element amounts to significantly more, this claim also fails both Step 2A prong 2, thus this claim is directed to the judicial exception as it has not been integrated into practical application, and fails Step 2B as not amounting to significantly more. Therefore, claim 36 does not recite patent eligible subject matter under 35 U.S.C. § 101.
Regarding claim 37, it recites an additional element recitation of “wherein the one or more manipulations further include: translations along an axis or curve, rotation about an axis or centroid, and rotation about a center of mass” is merely an insignificant extra-solution data gathering activity (see MPEP § 2106.05(g)) which does not integrate a judicial exception into practical application. Further, the insignificant extra-solution data gathering, record update, and data transmission activities are also Well-Understood, Routine and Conventional (see MPEP § 2106.05(d)(II), “The courts have recognized the following computer functions as well understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. i. Receiving or transmitting data over a network, ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory”). Further, this claim does not recite any further additional elements and for the same reasons as above with regard to integration into practical application and whether additional element amounts to significantly more, this claim also fails both Step 2A prong 2, thus this claim is directed to the judicial exception as it has not been integrated into practical application, and fails Step 2B as not amounting to significantly more. Therefore, claim 37 does not recite patent eligible subject matter under 35 U.S.C. § 101.
Therefore, having concluded the analysis within the provided framework, claims 1-10, 25-26, 28-31, 33-39 do not recite patent eligible subject matter and are rejected under 35 U.S.C. § 101 because the claimed invention is directed to judicial exception, an abstract idea, that has not been integrated into a practical application. The claims further do not recite significantly more than the judicial exception. Claims 2-10 and 25-26, 28, and 35-36; claims 30-31, 33, 37-38; and claim 39 are also rejected for incorporating the deficiency of their dependent claims 1, 29, and 34.
Claim Rejections - 35 U.S.C. § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claims 1-6, 8-9, 25, 28-30, 33-39 are rejected under 35 U.S.C. § 103 as being unpatentable over US 2020/0093542 A1 Arramon et al. [herein “Arramon”] in view of US 2017/0252107 A1 Turner, Alex et al. [herein “Turner”].
As per claim 1, Arramon teaches “A computer-implemented method for designing a patient-specific arthroplasty device”. (Para. 23, “Robotic and automated systems and methods for preparing vertebrae for an intervertebral disc implant” [method for designing an arthroplasty device]. Para. 32, “In the case of automatic implant selection, measurements of the 3D model are made by the computer processor and the processor determines the best fitting intervertebral disc prosthesis based on the 3D model measurements” [computer-implemented method]. Para. 31, “As shown in FIG. 3, the surgical method for preparing a vertebral disc space for implantation of an intervertebral disc prosthesis includes a first step 50 of imaging the patient” [patient-specific]. Further see Para. 23 and 31. The examiner has interpreted that a method for determining an intervertebral disc implant by modeling a patient’s imaging through the use of a computer processor as a computer-implemented method for designing a patient-specific arthroplasty device.)
Arramon also teaches “obtaining patient data associated with one or more regions of a patient's spine”. (Para. 31, “As shown in FIG. 3, the surgical method for preparing a vertebral disc space for implantation of an intervertebral disc prosthesis includes a first step 50 of imaging the patient” [obtaining patient data associated with a patient's spine]. Para. 65, “The robotic systems and methods of the present invention can be used an any one or multiple of the disc levels C1-C7 shown in FIG. 6 or in one or more levels of the lumbar or thoracic spine” [one or more regions of a patient's spine]. Further see Para. 23 and 65. The examiner has interpreted that imaging the patient to implement an intervertebral disc prosthesis for any one discs levels as obtaining patient data associated with one or more regions of a patient's spine.)
Arramon also teaches “generating an interactive virtual model of the one or more regions of the patient's spine based on the patient data, the interactive virtual model depicting (a) individual vertebrae within the one or more regions of the patient's spine, and (b) centers of rotation for corresponding vertebral segments of the patient's spine”. (Para. 44, “a preliminary 3D model of the anatomical area for surgery is created from preoperative CT scan data. Software or the surgeon can use the preliminary 3D model to make a preliminary determination of the intervertebral disc prosthesis to be selected” [generating an interactive virtual model of patient's spine based on the patient data]. Para. 65, “The robotic systems and methods of the present invention can be used an any one or multiple of the disc levels C1-C7 shown in FIG. 6 or in one or more levels of the lumbar or thoracic spine” [one or more regions of a patient's spine, and the interactive virtual model depicting (a) individual vertebrae within the one or more regions of the patient's spine]. Para. 34, “the determination of the natural centers of rotation can be calculated from measurements of the actual patient in the 3D model either pre-operatively or intraoperatively” [centers of rotation for corresponding vertebral segments of the patient's spine]. Further see Para. 34, 44, and 65. The examiner has interpreted that creating a preliminary 3D model of the anatomical area for any one discs levels from the actual patent that includes one or multiple of the disc levels of the spine and the calculated natural centers of rotation from measurements of the actual patient in the 3D model as generating an interactive virtual model of the one or more regions of the patient's spine based on the patient data, the interactive virtual model depicting (a) individual vertebrae within the one or more regions of the patient's spine, and (b) centers of rotation for corresponding vertebral segments of the patient's spine.)
Arramon also teaches “preoperatively receiving one or more manipulations from a user to manipulate a spatial relationship between one or more of the individual vertebrae within the interactive model to design a target post-surgical anatomical configuration for the one or more regions”. (Para. 65, “The robotic systems and methods of the present invention can be used an any one or multiple of the disc levels C1-C7 shown in FIG. 6 or in one or more levels of the lumbar or thoracic spine” [one or more regions of a patient's spine]. Para. 33, “In a next step 56 of determining a desired location for the selected intervertebral disc prosthesis, a desired location for the intervertebral disc prosthesis is determined either automatically or manually with respect to the positions of the first and second vertebrae” [a spatial relationship between one or more of the individual vertebrae within the interactive model design a target post-surgical anatomical configuration for the one or more regions of a patient's spine]. Para. 20, “The surgeon may need to reshape (or shape) the surfaces of the vertebrae to receive a flat or shaped endplate or to cut a channel to receive a fin or teeth of an endplate” [receiving one or more manipulations from a user to manipulate a spatial relationship between one or more of the individual vertebrae]. Para. 4, “Common causes of back pain are injury, degeneration and/or dysfunction of one or more intervertebral discs” [e.g., initial vertebrae movement or rotations that is not targeted]. Para. 24, “one example of an intervertebral disc prosthesis 10 for insertion between adjacent vertebrae includes an upper plate 12, a lower plate 14 and a core (not shown) between the upper and lower plates. The core is retained between the upper and lower plates by a retention feature and is designed to allow the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction and in the lateral direction and to allow the plates to articulate and rotate with respect to each other and the core” [inserting a prosthesis to allow movement and rotation of plates on vertebrae, e.g., manipulating a spatial relationship between one or more of the individual vertebrae to design a target post-surgical anatomical configuration for the one or more regions]. Para. 34, “the determination of the natural centers of rotation can be calculated from measurements of the actual patient in the 3D model either pre-operatively” [preoperatively]. Further see Para, 4, 20, 24, 33-34, and 65. The examiner has interpreted that determining location for the selected intervertebral disc prosthesis with respect to the positions of the first and second vertebrae that allows the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction through the determination by a surgeon to reshaped vertebra to fit the implant from a result of the dysfunction of the initial intervertebral disc to determine the nature centers of rotation of the actual patient in the model pre-operatively as preoperatively receiving one or more manipulations from a user to manipulate a spatial relationship between one or more of the individual vertebrae within the interactive model to design a target post-surgical anatomical configuration for the one or more regions.)
Arramon also teaches “determining, based at least in part on the interactive virtual model showing the target post-surgical anatomical configuration, (1) one or more target post-surgical kinematic parameters for the one or more regions of the patient's spine associated with the target post-surgical anatomical configuration, the one or more target post-surgical kinematic parameters including a target post-surgical type of motion and/or degree of motion and (2) one or more target post-surgical centers of rotation for the one or more regions of the patient's spine associated with the target post-surgical anatomical configuration”. (Para. 44, “a preliminary 3D model of the anatomical area for surgery is created from preoperative CT scan data. Software or the surgeon can use the preliminary 3D model to make a preliminary determination of the intervertebral disc prosthesis to be selected” [based at least in part an interactive virtual model of patient's spine showing the target post-surgical anatomical configuration]. Para. 65, “The robotic systems and methods of the present invention can be used an any one or multiple of the disc levels C1-C7 shown in FIG. 6 or in one or more levels of the lumbar or thoracic spine” [one or more regions of a patient's spine, and associated with the target post-surgical anatomical configuration]. Para. 24, “one example of an intervertebral disc prosthesis 10 for insertion between adjacent vertebrae includes an upper plate 12, a lower plate 14 and a core (not shown) between the upper and lower plates. The core is retained between the upper and lower plates by a retention feature and is designed to allow the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction and in the lateral direction and to allow the plates to articulate and rotate with respect to each other and the core” [determining (1) one or more target post-surgical kinematic parameters for the one or more regions of the patient's spine, the one or more target post-surgical kinematic parameters including a target post-surgical type of motion and/or degree of motion]. Para. 33, “In general, the desired position for the disc prosthesis is located centrally between left and right side edges of the vertebrae on the midline of the spine and with a center of rotation of the disc prosthesis at the natural center of rotation for a healthy disc or the actual center of rotation for a particular patient” [(2) one or more target post-surgical centers of rotation for the one or more regions of the patient's spine associated with the target post-surgical anatomical configuration]. Further see Para. 24, 33-34, 44, and 65. The examiner has interpreted that determining location for the selected intervertebral disc prosthesis with allows the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction and in the lateral direction and has a center of rotation of the disc prosthesis at the natural center of rotation for a healthy disc using a model that determines a location for the prosthesis for multiple of the disc levels for the patient as determining, based at least in part on the interactive virtual model showing the target post-surgical anatomical configuration, (1) one or more target post-surgical kinematic parameters for the one or more regions of the patient's spine associated with the target post-surgical anatomical configuration, the one or more target post-surgical kinematic parameters including a target post-surgical type of motion and/or degree of motion and (2) one or more target post-surgical centers of rotation for the one or more regions of the patient's spine associated with the target post-surgical anatomical configuration.)
Arramon also teaches “designing the patient-specific arthroplasty device based on the target post-surgical anatomical configuration, the target post-surgical kinematic parameters, and the target post-surgical centers of rotation”. (Para. 32, “In the case of automatic implant selection, measurements of the 3D model are made by the computer processor and the processor determines the best fitting intervertebral disc prosthesis based on the 3D model measurements” [designing the patient-specific arthroplasty device]. Para. 24, “The core is retained between the upper and lower plates by a retention feature and is designed to allow the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction and in the lateral direction” [target post-surgical kinematic parameters] “and to allow the plates to articulate and rotate with respect to each other and the core” [centers of rotation]. Para. 33, “In general, the desired position for the disc prosthesis is located centrally between left and right side edges of the vertebrae on the midline of the spine” [target post-surgical anatomical configuration] “and with a center of rotation of the disc prosthesis at the natural center of rotation for a healthy disc or the actual center of rotation for a particular patient” [target post-surgical centers of rotation]. Further see Para. 24 and 32-33. The examiner has interpreted that determines the best fitting intervertebral disc prosthesis based on the 3D model measurements in a desired position on the vertebrae the spine to allow the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction and in the lateral direction and to allow the plates to articulate and rotate at the natural center of rotation for a healthy disc as designing the patient-specific arthroplasty device based on the target post-surgical anatomical configuration, the target post-surgical kinematic parameters, and the target post-surgical centers of rotation.)
Arramon does not specifically teach “generating a patient-specific treatment plan, wherein the patient-specific treatment plan includes (a) a plurality of images of the target post-surgical anatomical configuration taken from the interactive virtual model, and (b) the target postsurgical kinematic parameters and the target post-surgical centers of rotation”, “sending the patient-specific treatment plan to a user device for display for user review, modification, approval, and/or rejection of the target post-surgical centers of rotation” and “in response to receiving user approval of the target post-surgical centers of rotation, generating computer-executable fabrication instructions for fabricating the patient-specific arthroplasty device”.
However, in the same field of endeavor namely creating prosthetic spinal discs, Turner teaches “generating a patient-specific treatment plan, wherein the patient-specific treatment plan includes (a) a plurality of images of the target post-surgical anatomical configuration taken from the interactive virtual model, and (b) the target postsurgical kinematic parameters and the target post-surgical centers of rotation”. (Para. 0040, “Based on the received at least one digitized position 14 of the one or more vertebral bodies 4, the control unit 16 is configured to predict, or determine, a simulated postoperative surgical correction 24 (i.e., predict how a surgical correction, such as a posterior lumbar interbody fusion or anterior lumbar interbody fusion, will affect the posture of the subject 2). The control unit 16 may be configured to determine, for example, the simulated postoperative surgical correction 24 that would result in, or close to, the optimized posture 18 for the subject 2” [target post-surgical anatomical configuration]. “Based on the simulated postoperative surgical correction 24, the control unit 16 may be configured to determine, and display to a surgeon, a recommended surgical plan 26 to implement the predicted simulated postoperative surgical correction 24” [generating a patient-specific treatment plan wherein the patient-specific treatment plan includes the target post-surgical anatomical configuration taken from the interactive virtual model]. Para. 0040, The communicated predicted simulated postoperative spinal correction 24, and/or recommended surgical plan 26 may be transmitted as an output 28. By way of example, the output 28 may be an image representation, a graphical display, or a numerical value” [wherein the patient-specific treatment plan includes an image of the target post-surgical anatomical configuration taken from the interactive virtual model]. Para. 0040, “Based on the received at least one digitized position 14 of the one or more vertebral bodies 4, the control unit 16 is configured to predict, or determine, a simulated postoperative surgical correction 24 (i.e., predict how a surgical correction, such as a posterior lumbar interbody fusion or anterior lumbar interbody fusion, will affect the posture of the subject 2)” [e.g., include one image for position]. Para. 0038, “and the control unit 16 may select digitized positions 14 based on output from the image recognition software. The image recognition software, by way of example, may process the image and identify and transmit the positions 14, such as the corners of the one or more vertebral bodies 4. In some embodiments, this processing and identification is automatic, while in other embodiments, a user manually selects or verifies the positions 14 from data provided to the control unit 16 such that the control unit 16 receives the digitized positions 14 from the user. In yet another embodiment, the digitized positions 14 are received digitally from a digital imaging component, such as a digital radiography system. The digitized positions 14 may be displayed using medical modeling system” [multiple positions, e.g., a plurality of images of the target post-surgical anatomical configuration]. Para. 0048, “the control unit 16 may contain anatomical modeling software capable of, or configured to, simulate kinematics and muscular and joint loads in the full body for typical activities of a subject 2 and for fundamental human body motions” [e.g., (b) the target postsurgical kinematic parameters]. Para. 0047, “the control unit 16 may input or use global alignment parameters such as global sagittal axis, three-dimensional parameters such as rotation” [e.g., the target post-surgical centers of rotation]. Further see Para. 0038, 0040, and 047-0048. The examiner has interpreted that determining a recommended surgical plan to implement the predicted simulated postoperative surgical correction which is how a surgical correction will affect the posture of the subject for an optimized posture that shows the results of the predicted simulation as an output image for a received position and simulating the kinematic loads for the subject in typical activities for human body motion and using alignment parameters such as rotation for multiple received digitized positions as generating a patient-specific treatment plan, wherein the patient-specific treatment plan includes (a) a plurality of images of the target post-surgical anatomical configuration taken from the interactive virtual model, and (b) the target postsurgical kinematic parameters and the target post-surgical centers of rotation.)
Turner also teaches “sending the patient-specific treatment plan to a user device for display for user review, modification, approval, and/or rejection of the target post-surgical centers of rotation”. (Para. 0040, “Based on the simulated postoperative surgical correction 24, the control unit 16 may be configured to determine, and display to a surgeon, a recommended surgical plan 26 to implement the predicted simulated postoperative surgical correction 24” [sending the patient-specific treatment plan to a user device for display]. Para. 0047, “the control unit 16 may input or use global alignment parameters such as global sagittal axis, three-dimensional parameters such as rotation” [e.g., the target post-surgical centers of rotation]. Para. 0042, “Thus, the user (i.e., surgeon) can iteratively change an input plan or input parameters until the goal, such as optimal posture, is achieved” [for user review, modification, approval, and/or rejection of the target post-surgical centers of rotation]. Further see Para, 0040, 0042, and 0047. The examiner has interpreted that determining and displaying a recommended surgical plan based on the simulated postoperative surgical correction to a surgeon who can change the input plan and input parameters such as rotation until the optimal posture is achieved as sending the patient-specific treatment plan to a user device for display for user review, modification, approval, and/or rejection of the target post-surgical centers of rotation.)
Turner also teaches “in response to receiving user approval of the target post-surgical centers of rotation, generating computer-executable fabrication instructions for fabricating the patient-specific arthroplasty device”. (Para. 0047, “the control unit 16 may input or use global alignment parameters such as global sagittal axis, three-dimensional parameters such as rotation” [e.g., the target post-surgical centers of rotation]. Para. 0042, “Thus, the user (i.e., surgeon) can iteratively change an input plan or input parameters until the goal, such as optimal posture, is achieved” [e.g., in response to receiving user approval of the target post-surgical centers of rotation]. Para. 0055, “the system 10 may include a three dimensional printer (i.e., an additive manufacturing device or a subtractive manufacturing device) 48 in communication with the control unit 16. The three dimensional printer 48 may be configured to create, or partially create, the determined implant 46. Advantageously, this feature of the described disclosure allows for personalized surgical implants that are optimized for clinical benefit in the subject 2 to achieve optimized posture 18. The control unit 16 may be configured to transmit digital data 50 about the implant 46 for the printer 48 to manufacture the implant 46” [e.g., generating computer-executable fabrication instructions for fabricating the patient-specific arthroplasty device]. Further see Para. 0042, 0047 and 0055. The examiner has interpreted that changing the input plan and input parameters such a three dimensional rotation by a surgeon to achieve optimal posture to create a determined implant for achieving the optimized posture through the control unit that transmits digital data about the implant to a printer to manufacture the implant as in response to receiving user approval of the target post-surgical centers of rotation, generating computer-executable fabrication instructions for fabricating the patient-specific arthroplasty device.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “generating a patient-specific treatment plan, wherein the patient-specific treatment plan includes (a) a plurality of images of the target post-surgical anatomical configuration taken from the interactive virtual model, and (b) the target postsurgical kinematic parameters and the target post-surgical centers of rotation”, “sending the patient-specific treatment plan to a user device for display for user review, modification, approval, and/or rejection of the target post-surgical centers of rotation”, and “in response to receiving user approval of the target post-surgical centers of rotation, generating computer-executable fabrication instructions for fabricating the patient-specific arthroplasty device”, as conceptually seen from the teaching of Turner, into that of Arramon because this modification of creating an personal treatment plan and implant for the advantageous purpose of verification of patient optimized device for the long-term health of the patient (Turner, Para. 0005, 0040-0042, and 0055). Further motivation to combine be that Arramon and Turner are analogous art to the current claim are directed to creating prosthetic spinal discs.
As per claim 2, Arramon teaches “wherein the patient-specific arthroplasty device comprises: a first end-plate having a first patient-specific topography, a second end-plate having a second patient-specific topography”. (Para. 24, “one example of an intervertebral disc prosthesis 10 for insertion between adjacent vertebrae includes an upper plate 12, a lower plate 14” [wherein the patient-specific arthroplasty device comprises: a first end-plate, a second end-plate]. Para. 26, “the upper and lower plates can have different configurations to more closely match the anatomy of the patient” [a first end-plate having a first patient-specific topography, a second end-plate having a second patient-specific topography]. The examiner has interpreted that an intervertebral disc prosthesis that includes an upper and lower plates which have different configurations to more closely match the anatomy of the patient as wherein the patient-specific arthroplasty device comprises: a first end-plate having a first patient-specific topography, a second end-plate having a second patient-specific topography.)
Arramon also teaches “a mobility element disposed between the first end-plate and the second end-plate, wherein the mobility element is designed to comply with the one or more target post-surgical kinematic parameters and to achieve the target post-surgical center of rotation when the patient-specific arthroplasty device is implanted in the patient's spine”. (Para. 24, “one example of an intervertebral disc prosthesis 10 for insertion between adjacent vertebrae includes an upper plate 12, a lower plate 14 and a core (not shown) between the upper and lower plates” [mobility element disposed between the first end-plate and the second end-plate when the patient-specific arthroplasty device is implanted in the patient's spine]. “The core is retained between the upper and lower plates by a retention feature and is designed to allow the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction and in the lateral direction and to allow the plates to articulate and rotate with respect to each other and the core” [mobility element is designed to comply with the one or more target post-surgical kinematic parameters and to achieve the target post-surgical center of rotation]. The examiner has interpreted that an intervertebral disc prosthesis for insertion between adjacent vertebrae that includes a core that allows the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction and in the lateral direction and allows the plates to articulate and rotate with respect to each other and the core as a mobility element disposed between the first end-plate and the second end-plate, wherein the mobility element is designed to comply with the one or more target post-surgical kinematic parameters and to achieve the target post-surgical center of rotation when the patient-specific arthroplasty device is implanted in the patient's spine.)
As per claim 3, Arramon teaches “wherein the mobility element is designed for allowing (1) rotation of the first end-plate and the second end-plate relative to each other, and (2) translation of the first end-plate and the second end-plate relative to each other”. (Para. 24, “one example of an intervertebral disc prosthesis 10 for insertion between adjacent vertebrae includes an upper plate 12, a lower plate 14 and a core (not shown) between the upper and lower plates. The core is retained between the upper and lower plates by a retention feature and is designed to allow the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction and in the lateral direction and to allow the plates to articulate and rotate with respect to each other and the core”. The examiner has interpreted that a core that allows the plates to slide in the anterior/posterior and lateral directions and allows the plates to articulate and rotate with respect to each other as wherein the mobility element is designed for allowing (1) rotation of the first end-plate and the second end-plate relative to each other, and (2) translation of the first end-plate and the second end-plate relative to each other.)
As per claim 4, Arramon teaches “wherein the mobility element is designed for allowing six degrees of freedom of movement between the first end-plate and the second end-plate”. (Para. 24, “The core is retained between the upper and lower plates by a retention feature and is designed to allow the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction and in the lateral direction and to allow the plates to articulate and rotate with respect to each other and the core” [wherein the mobility element is designed for allowing six degrees of freedom of movement between the first end-plate and the second end-plate]. The examiner has interpreted that a core that allows the plates to slide in the anterior/posterior and lateral directions and allows the plates to articulate and rotate with respect to each other as wherein the mobility element is designed for allowing six degrees of freedom of movement between the first end-plate and the second end-plate.)
As per claim 5, Arramon teaches “wherein the patient data includes image data depicting a native anatomical configuration of the one or more regions of the patient's spine”. (Para. 43, “The imaging system generates a 3D model of at least the vertebrae above and below the natural disc to be replaced and can also generate a 3D model of additional anatomic structures” [depicting a native anatomical configuration]. “This 3D model can be based on a number of different imaging modalities including imaging with X-ray, CT scan, MRI, photograph or a combination of these methods” [e.g., the patient data includes image data depicting a native anatomical configuration]. Para. 65, “The robotic systems and methods of the present invention can be used an any one or multiple of the disc levels C1-C7 shown in FIG. 6 or in one or more levels of the lumbar or thoracic spine” [one or more regions of a patient's spine]. The examiner has interpreted that obtaining a 3D model of the vertebrae natural disc locations through imaging a patient’s spine levels as wherein the patient data includes image data depicting a native anatomical configuration of the one or more regions of the patient's spine.)
As per claim 6, Arramon teaches “wherein the patient data includes kinematic data associated with the one or more regions of a patient's spine, wherein the kinematic data includes values for one or more kinematic parameters”. (Para. 31, “the surgical method for preparing a vertebral disc space for implantation of an intervertebral disc prosthesis includes a first step 50 of imaging the patient. The step of imaging will be described in further detail below and may include imaging with X-ray, CT scan, MRI, photographs or a combination of these methods” [the patient data associated with the one or more regions of a patient's spine]. Para. 34, “the center of rotation is measured in the sagittal plane between the extremes of motion using maximum flexion and extension X-ray images” [patient data includes kinematic data, wherein the kinematic data includes values for one or more kinematic parameters]. The examiner has interpreted that measuring motion through the vertebral x-ray images of the patient as wherein the patient data includes kinematic data associated with the one or more regions of a patient's spine, wherein the kinematic data includes values for one or more kinematic parameters.)
As per claim 8, Arramon teaches “wherein the one or more target post-surgical centers of rotation are different than corresponding pre-surgical centers of rotation”. (Para. 4, “With age, intervertebral disks begin to shrink. In some cases, they may collapse completely and cause the bones to rub against one another” [e.g., pre-surgical centers of rotation]. Para. 33, “the desired position for the disc prosthesis is located centrally between left and right side edges of the vertebrae on the midline of the spine and with a center of rotation of the disc prosthesis at the natural center of rotation for a healthy disc or the actual center of rotation for a particular patient.” [e.g. target post-surgical centers of rotation]. Para. 6, “The TDR procedure involves removing the natural disk from between the vertebrae and replacing it with and artificial disc prosthesis”. Para. 35, “Traditional cervical intervertebral disc replacements which incorporate a ball-and-socket design (e.g. ProDisc-C, Discover), but no translation features, provide a fixed center of rotation and thus require a precise device placement to replicate anatomic centers of rotation and restoration of natural kinematics” [target post-surgical centers of rotation]. The examiner has interpreted that replacing an intervertebral disc that has shrunk or collapsed with an artificial disc prosthesis that has a center of rotation of a healthy disc as wherein the one or more target post-surgical centers of rotation are different than corresponding pre-surgical centers of rotation.)
As per claim 9, Arramon teaches “wherein the one or more target post-surgical kinematic parameters are different than corresponding pre-surgical kinematic parameters”. (Para. 4, “Common causes of back pain are injury, degeneration and/or dysfunction of one or more intervertebral discs” [range of motion that is not representative of a healthy disc, e.g., pre-surgical kinematic parameters]. “Intervertebral discs are the soft tissue structures located between each of the thirty-three vertebral bones that make up the vertebral (spinal) column. Essentially, the discs allow the vertebrae to move relative to one another”. Para. 6, “The TDR procedure involves removing the natural disk from between the vertebrae and replacing it with and artificial disc prosthesis” [i.e., target kinematic parameters are different from pre-surgical kinematic parameters]. Para. 35, “Traditional cervical intervertebral disc replacements which incorporate a ball-and-socket design (e.g. ProDisc-C, Discover), but no translation features, provide a fixed center of rotation and thus require a precise device placement to replicate anatomic centers of rotation and restoration of natural kinematics” [target post-surgical kinematic parameters]. The examiner has interpreted that removing a dysfunction intervertebral disc and replacing it with an artificial disc prosthesis that restores the natural kinematics as wherein the one or more target post-surgical kinematic parameters are different than corresponding pre-surgical kinematic parameters.)
As per claim 25, Arramon teaches “automatically calculating and displaying, in real time and during preoperatively manipulating the spatial relationship, changes in the centers of rotation for vertebral segments corresponding to the manipulations of the individual vertebrae”. (Para. 33, “In a next step 56 of determining a desired location for the selected intervertebral disc prosthesis, a desired location for the intervertebral disc prosthesis is determined either automatically or manually with respect to the positions of the first and second vertebrae” [automatically manipulating and calculating the spatial relationship for vertebral segments corresponding to the manipulations of the individual vertebrae]. Para. 4, “Common causes of back pain are injury, degeneration and/or dysfunction of one or more intervertebral discs” [e.g., initial vertebrae movement or rotations that is not targeted]. Para. 24, “one example of an intervertebral disc prosthesis 10 for insertion between adjacent vertebrae includes an upper plate 12, a lower plate 14 and a core (not shown) between the upper and lower plates. The core is retained between the upper and lower plates by a retention feature and is designed to allow the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction and in the lateral direction and to allow the plates to articulate and rotate with respect to each other and the core” [inserting a prosthesis to allow movement and rotation of plates on vertebrae, e.g., changes in the centers of rotation for vertebral segments corresponding to the manipulations of the individual vertebrae ]. Para. 34, “the determination of the natural centers of rotation can be calculated from measurements of the actual patient in the 3D model either pre-operatively” [preoperatively calculating and displaying changes]. Para. 44, “The 3D model is updated with intraoperative fluoroscopic image data or other image data of the vertebrae having the markers to allow real time 3D tracking of the precise position of the vertebrae above and below the disc to be replaced throughout surgery” [e.g., in real time] . Further see Para, 4, 24, 33-34, 44, and 65. The examiner has interpreted that determining location for the selected intervertebral disc prosthesis with respect to the positions of the first and second vertebrae automatically that allows the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction and rotate with respect to each other to address the result of the dysfunction of the initial intervertebral disc and determining the natural centers of rotation of the actual patient in the model pre-operatively to allow real time track if the vertebrae positions as automatically calculating and displaying, in real time and during preoperatively manipulating the spatial relationship, changes in the centers of rotation for vertebral segments corresponding to the manipulations of the individual vertebrae.)
As per claim 28, Arramon does not specifically teach “manufacturing the patient-specific arthroplasty device by causing a manufacturing system to execute the computer-executable fabrication instructions”.
However, Turner teaches “manufacturing the patient-specific arthroplasty device by causing a manufacturing system to execute the computer-executable fabrication instructions”. (Para. 0055, “the system 10 may include a three dimensional printer (i.e., an additive manufacturing device or a subtractive manufacturing device) 48 in communication with the control unit 16. The three dimensional printer 48 may be configured to create, or partially create, the determined implant 46. Advantageously, this feature of the described disclosure allows for personalized surgical implants that are optimized for clinical benefit in the subject 2 to achieve optimized posture 18. The control unit 16 may be configured to transmit digital data 50 about the implant 46 for the printer 48 to manufacture the implant 46” [e.g., manufacturing the patient-specific arthroplasty device by causing a manufacturing system to execute the computer-executable fabrication instructions]. Further see Para. 0055. The examiner has interpreted that creating a determined implant for achieving the optimized posture through the control unit that transmits digital data about the implant to a printer to manufacture the implant as manufacturing the patient-specific arthroplasty device by causing a manufacturing system to execute the computer-executable fabrication instructions.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “manufacturing the patient-specific arthroplasty device by causing a manufacturing system to execute the computer-executable fabrication instructions”, as conceptually seen from the teaching of Turner, into that of Arramon because this modification of creating an personal treatment plan and implant that is modified for the advantageous purpose of verification and creation of patient optimized device for the long-term health of the patient (Turner, Para. 0005, 0040-0042, and 0055). Further motivation to combine be that Arramon and Turner are analogous art to the current claim are directed to creating prosthetic spinal discs.
Re Claim 29, it is an articles of manufacture claim, having similar limitations of claim 1. Thus, claim 29 is also rejected under the similar rationale as cited in the rejection of claim 1.
Furthermore, Arramon teaches “A non-transitory computer-readable medium storing instructions that, when executed by a computing system, cause the computing system to perform operations for designing a patient-specific arthroplasty device”. (Para. 32, “In the case of automatic implant selection, measurements of the 3D model are made by the computer processor and the processor determines the best fitting intervertebral disc prosthesis based on the 3D model measurements” [e.g., when executed by a computing system cause the computing system to perform operations for designing a patient-specific arthroplasty device]. Para. 52, “The desired location for the selected intervertebral disc prosthesis with respect to the positions of the first and second vertebrae position data for the intervertebral disc prosthesis location is stored in the computer system 106” [e.g., a non-transitory computer-readable medium storing instructions that]. Further see Para. 32 and 52. The examiner has interpreted that a computer system that stores measurement data for a 3D model of implant selection and determines the best fitting intervertebral disc prosthesis based on the 3D model measurements as A non-transitory computer-readable medium storing instructions that, when executed by a computing system, cause the computing system to perform operations for designing a patient-specific arthroplasty device.)
Re Claim 30, it is an articles of manufacture claim, having similar limitations of claim 25. Thus, claim 30 is also rejected under the similar rationale as cited in the rejection of claim 25.
Re Claim 33, it is an articles of manufacture claim, having similar limitations of claim 28. Thus, claim 33 is also rejected under the similar rationale as cited in the rejection of claim 28.
Re Claim 34, it is a system claim, having similar limitations of claim 1. Thus, claim 34 is also rejected under the similar rationale as cited in the rejection of claim 1.
Furthermore, regarding claim 34, Arramon teaches “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”. (Para. 32, “In the case of automatic implant selection, measurements of the 3D model are made by the computer processor and the processor determines the best fitting intervertebral disc prosthesis based on the 3D model measurements” [e.g., a system comprising: one or more processors; when executed by the one or more processors, cause the system to perform a process]. Para. 52, “The desired location for the selected intervertebral disc prosthesis with respect to the positions of the first and second vertebrae position data for the intervertebral disc prosthesis location is stored in the computer system 106” [e.g., one or more memories storing instructions]. Further see Para. 32 and 52. The examiner has interpreted that a computer system that stores measurement data for a 3D model of implant selection and a processor that determines the best fitting intervertebral disc prosthesis based on the 3D model measurements as 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.)
As per claim 35, Arramon teaches “wherein the target post-surgical kinematic parameters include: a range of motion, an angle of bend, an angle of rotation, flexion/extension arcs, [and left or right bending arcs]”. (Para. 24, “The core is retained between the upper and lower plates by a retention feature and is designed to allow the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction and in the lateral direction” [range of motion]. Para. 29, “In the constrained insertion configuration, the upper and lower plates 32, 34 can be parallel, as shown in FIG. 2, or slightly angled with the posterior edges of the plates closer to one another for insertion in a wedge shape from an anterior of the spine” [angle of bend]. Para. 48, “Implant trials with various lordosis angles may also be tested if available” [angle of bend]. Para. 33, “In general, the desired position for the disc prosthesis is located centrally between left and right side edges of the vertebrae on the midline of the spine and with a center of rotation of the disc prosthesis at the natural center of rotation for a healthy disc or the actual center of rotation for a particular patient”. Para. 48, “the control unit 16 may contain anatomical modeling software capable of, or configured to, simulate kinematics and muscular and joint loads in the full body for typical activities of a subject 2 and for fundamental human body motions” [angle of rotation]. Para. 34, “The center of rotation is measured in the sagittal plane between the extremes of motion using maximum flexion and extension X-ray images or in the 3D model” [flexion/extension arcs]. Further see Para. 24, 29, 33, and 48. The examiner has interpreted that determining the position of the prosthesis that allows the plates to slide in the anterior/posterior direction and in the lateral direction, with slightly angled with the posterior edges of the plates closer to one another for insertion in a wedge shape from an anterior of the spine, with various lordosis angles, the desired position having a center of rotation matching a healthy disc to simulate the full fundamental human body motion and measure from the flexion and extension images as wherein the target post-surgical kinematic parameters include: a range of motion, an angle of bend, an angle of rotation, and flexion/extension arcs.)
Arramon does not specifically teach “wherein the target post-surgical kinematic parameters include: left or right bending arcs”.
However, Turner teaches “wherein the target post-surgical kinematic parameters include: left or right bending arcs”. (Para. 0043, “The optimized posture 18 may have a spine with a Cobb angle of between 0 and 10 degrees, 2 and 8 degrees, or 2 and 6 degrees, or any combination of those values. The Scoliosis subject 2 may have a spinal Cobb of greater than 10 degrees, greater than 15 degrees, greater than 20 degrees, greater than 40 degrees, greater than 50 degrees, or greater than 60 degrees” [right bending arc]. Para. 0045, “The control unit 16 may also be configured to receive and process center of mass migration 57. Knee flexion refers to joint angle between the bones of the limb at the knee joint. Knee flexion values may be, for example, between minus 10 and 150 degrees. Pelvic movement may include pelvic retroversion, pelvic anteversion, and pelvic tilt.” [left bending arc]. Further see Para. 0043-0045. The examiner has interpreted that calculating the optimized posture using an implant to have a spine with a Cobb angle between 0 and 10 degrees and pelvic tilt as wherein the target post-surgical kinematic parameters include: left and right bending arcs.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “wherein the target post-surgical kinematic parameters include: left or right bending arcs”, as conceptually seen from the teaching of Turner, into that of Arramon because this modification of including additional target parameters for the advantageous purpose of verification and creation of patient optimized device for the long-term health of the patient (Turner, Para. 0005, 0040-0042, and 0055). Further motivation to combine be that Arramon and Turner are analogous art to the current claim are directed to creating prosthetic spinal discs.
As per claim 36, Arramon teaches “wherein the one or more manipulations include changes to: a distance between two or more individual vertebrae, and an angular relationship between the two or more individual vertebrae”. (Para. 24, “one example of an intervertebral disc prosthesis 10 for insertion between adjacent vertebrae includes an upper plate 12, a lower plate 14 and a core (not shown) between the upper and lower plates. The core is retained between the upper and lower plates by a retention feature and is designed to allow the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction and in the lateral direction and to allow the plates to articulate and rotate with respect to each other and the core” [e.g., wherein the one or more manipulations include changes to: a distance between two or more individual vertebrae, and an angular relationship between the two or more individual vertebrae]. Further see Para, 4, 20, 24, 33-34, and 65. The examiner has interpreted that allowing the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction and rotate with respect to each other on the vertebrae as wherein the one or more manipulations include changes to: a distance between two or more individual vertebrae, and an angular relationship between the two or more individual vertebrae.)
As per claim 37, Arramon teaches “wherein the one or more manipulations further include: translations along an axis or curve, rotation about an axis or centroid, [and rotation about a center of mass].” (Para. 4, “The vertebral column and discs are vital anatomical structures, in that they form a central axis that supports the head and torso, allow for movement of the back, and protect the spinal cord, which passes through the vertebrae in proximity to the discs” [axis or curve]. Para. 24, “one example of an intervertebral disc prosthesis 10 for insertion between adjacent vertebrae includes an upper plate 12, a lower plate 14 and a core (not shown) between the upper and lower plates. The core is retained between the upper and lower plates by a retention feature and is designed to allow the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction and in the lateral direction and to allow the plates to articulate and rotate with respect to each other and the core” [e.g., wherein the one or more manipulations further include translations along an axis or curve and rotation about an axis or centroid]. Furthermore, Para. 34, “Determination of the natural center of rotation of a healthy disc can be based on studies of quantitative motion analysis which have determined the idealized centers of rotation for each level of the spine in both the sagittal and coronal planes. Alternatively, the determination of the natural centers of rotation can be calculated from measurements of the actual patient in the 3D model either pre-operatively or intraoperatively. The center of rotation is measured in the sagittal plane between the extremes of motion using maximum flexion and extension X-ray images or in the 3D model” [rotation about an axis or centroid]. Further see Para, 4, 20, 24, 33-34, and 65. The examiner has interpreted that allowing the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction and rotate with respect to each other on the vertebrae and rotate with respect to each about the vertebral column that forms the central axis and determining the natural centers of rotation of a healthy disc about the sagittal and coronal planes as wherein the one or more manipulations further include: translations along an axis or curve and rotation about an axis or centroid.)
Arramon does not specifically teach “wherein the one or more manipulations further include: rotation about a center of mass”.
However, Turner teaches “wherein the one or more manipulations further include: rotation about a center of mass”. (Para. 0047, “Further, the control unit 16 may input or use global alignment parameters such as global sagittal axis, three-dimensional parameters such as rotation and scoliosis, and cervical parameters”. Para. 0045, “The control unit 16 may also be configured to receive and process center of mass migration 57” [wherein the one or more manipulations further include: rotation about a center of mass]. Further see Para. 0045-0047. The examiner has interpreted that calculating the optimized posture using an implant having processed the center of mass migration and rotation parameters as wherein the one or more manipulations further include: rotation about a center of mass.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “wherein the one or more manipulations further include: rotation about a center of mass”, as conceptually seen from the teaching of Turner, into that of Arramon because this modification of including additional target parameters for the advantageous purpose of verification and creation of patient optimized device for the long-term health of the patient (Turner, Para. 0005, 0040-0042, and 0055). Further motivation to combine be that Arramon and Turner are analogous art to the current claim are directed to creating prosthetic spinal discs.
Re Claim 38, it is an articles of manufacture claim, having similar limitations of claim 35. Thus, claim 38 is also rejected under the similar rationale as cited in the rejection of claim 35.
Re Claim 39, it is a system claim, having similar limitations of claim 35. Thus, claim 39 is also rejected under the similar rationale as cited in the rejection of claim 35.
Claims 7 and 10 are rejected under 35 U.S.C. § 103 as being unpatentable over Arramon and Turner as applied to claim 1 above, and further in view of US 8,613,771 B2 Hansell et al. [herein “Hansell”].
As per claim 7, Arramon nor Turner specifically teach “wherein at least one of the target post-surgical centers of rotation is offset from a geometric centerpoint between adjacent vertebral bodies in the one or more regions of the patient's spine”.
However, in the same field of endeavor namely creating prosthetic spinal discs, Hansell teaches “wherein at least one of the target post-surgical centers of rotation is offset from a geometric centerpoint between adjacent vertebral bodies in the one or more regions of the patient's spine”. (Col. 13 Ln. 58-62, “for the configuration shown in FIG. 29, the inserts may be positioned such that they are about 10[°] off of a vertical axis when the vertebral bodies are in a neutral position. In another embodiment, the angle may be from about 3° to about ISO” [having the insert offset from the vertical axis of the vertebral bodies, e.g., wherein at least one of the target post-surgical centers of rotation is offset from a geometric centerpoint between adjacent vertebral bodies in the one or more regions of the patient's spine]. The examiner has interpreted that offsetting the insert with respect to the vertebral bodies as wherein at least one of the target post-surgical centers of rotation is offset from a geometric centerpoint between adjacent vertebral bodies in the one or more regions of the patient's spine.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “wherein at least one of the target post-surgical centers of rotation is offset from a geometric centerpoint between adjacent vertebral bodies in the one or more regions of the patient's spine” as conceptually seen from the teaching of Hansell, into that of Arramon and Turner because this modification of obtaining a center of rotation that is offset with respect to the vertebral bodies for the advantageous purpose of controlling the amount of bending in the spine as to not affecting the nervous system (Hansell, Col. 2 Ln. 3-8 & Col. 13 Ln. 48-62). Further motivation to combine be that Arramon, Turner, and Hansell are analogous art to the current claim are directed to creating prosthetic spinal discs.
As per claim 10, Arramon nor Turner specifically teach “wherein the one or more target post-surgical kinematic parameters includes a target degree of rotation”.
However, Hansell teaches “wherein the one or more target post-surgical kinematic parameters includes a target degree of rotation”. (Col. 6 Ln. 3-5, “The interfacing surfaces of articulating and non-articulating embodiments of the present invention also allow for varying degrees of rotational and linear translation” [wherein the one or more target post-surgical kinematic parameters includes a degree of rotation]. Col. 18 Ln. 34-35, “Some assemblies may limit a range of axial rotation to ±15°, ±10°, ±5°, or ±2.°” [target degree of rotation]. The examiner has interpreted that a device that allows for a limited range of axial rotation as wherein the one or more target post-surgical kinematic parameters includes a target degree of rotation.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “wherein the one or more target post-surgical kinematic parameters includes a target degree of rotation” as conceptually seen from the teaching of Hansell, into that of Arramon and Turner because this modification of specifying the degree of rotation the advantageous purpose of controlling the amount of bending in the spine as to not affecting the nervous system (Hansell, Col. 2 Ln. 3-8 & Col. 5 Ln. 51-61). Further motivation to combine be that Arramon, Turner, and Hansell are analogous art to the current claim are directed to creating prosthetic spinal discs.
Claims 26 and 31 are rejected under 35 U.S.C. § 103 as being unpatentable over Arramon and Turner as applied to claim 1 above, and further in view of US 2022/0249168 A1 Besier et al. [herein “Besier”].
As per claim 26, Arramon nor Turner specifically teach “wherein generating the patient-specific treatment plan includes using a machine learning model to generate one or more aspects of the patient-specific treatment plan”.
However, in the same field of endeavor namely directed to creating prosthetic spinal discs, Besier teaches “wherein generating the patient-specific treatment plan includes using a machine learning model to generate one or more aspects of the patient-specific treatment plan”. (Para. 0115, “Approve and finalise implant selection and placement to prevent further modification and to produce documentation of the surgery plan for implant procurement, intra-operative guidance, and post-operative review” [generating the patient-specific treatment plan]. Para. 0086, “the model 104 may use machine learning to assist with predictive functions of the system” [e.g., using a machine learning model to generate one or more aspects of the patient-specific treatment plan]. Further see Para. 0086 and 0111-0115. The examiner has interpreted that producing documentation for the surgery plan for implant procurement and using machine learning to production functions that predict functions of the system as wherein generating the patient-specific treatment plan includes using a machine learning model to generate one or more aspects of the patient-specific treatment plan.)
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add “wherein generating the patient-specific treatment plan includes using a machine learning model to generate one or more aspects of the patient-specific treatment plan” as conceptually seen from the teaching of Besier, into that of Arramon and Turner because this modification of using machine learning for the advantageous purpose of improving the modeling of a patient specific device (Para. 0078). Further motivation to combine be that Arramon, Turner, and Besier are analogous art to the current claim are directed to directed to creating prosthetic spinal discs.
Re Claim 31, it is an articles of manufacture claim, having similar limitations of claim 26. Thus, claim 31 is also rejected under the similar rationale as cited in the rejection of claim 26.
Response to Arguments
Applicant's arguments filed on January 27, 2026 have been fully considered but they are not persuasive.
Applicant argues that amended claims 1, 29, and 34 features are patent eligible under 35 U.S.C. § 101 because the claims do not recite an abstract idea (See Applicant’s response, Pg. 11-13).
MPEP § 2106.04(a)(2)(III)(A) recites “claims do recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions”, “claims can recite a mental process even if they are claimed as being performed on a computer”, and “in evaluating whether a claim that requires a computer recites a mental process, examiners should carefully consider the broadest reasonable interpretation of the claim in light of the specification. For instance, examiners should review the specification to determine if the claimed invention is described as a concept that is performed in the human mind and applicant is merely claiming that concept performed 1) on a generic computer, or 2) in a computer environment, or 3) is merely using a computer as a tool to perform the concept. In these situations, the claim is considered to recite a mental process.”
The examiner has provided the rational for the claim limitations that are being directed to a mental process in the rejection above. For example, the limitation of amended claim 1 recites “determining, based at least in part on the interactive virtual model showing the target post-surgical anatomical configuration, (1) one or more target post-surgical kinematic parameters for the one or more regions of the patient's spine associated with the target post-surgical anatomical configuration, the one or more target post-surgical kinematic parameters including a target post-surgical type of motion and/or degree of motion, and (2) one or more target post-surgical centers of rotation for the one or more regions of the patient's spine associated with the target post-surgical anatomical configuration” is a mental process. For example, a person can mentally determine or draw with pen and paper a desired degree of motion and center of rotation of the patient’s spine regions that would be obtained after a surgery was implemented and while viewing the desired configuration by comparing the patient’s current degree of motion and center of rotation with a reference of an optimal spine region’s degree of motion and center of rotation for a similar patient. The claimed limitation merely states that the concept is performed using a processor and based on the model. As discussed, a person can view the model of the current patient and determine what corrections need to be made to achieve the desired degree of motion and center of rotation. Furthermore, the limitation of amended claim 1 recites “designing the patient-specific arthroplasty device based on the target post-surgical anatomical configuration, the target post-surgical kinematic parameters, and the target post-surgical centers of rotation” is a mental process. For example, a person can mentally create or draw with pen and paper a device by selecting and combining various components and materials that will yield the desired anatomical configuration, kinematic parameters, and the centers of rotation with a successful surgery. The claimed limitation merely states that the concept is performed using a processor only. As discussed, a person can choose, alter, and arranged components to form an implant that will yield the desired motion and center of rotation for a patient.
The examiner has properly identified that the claims recite a mental concept as provided in the rejection above is proper under the framework provided in the 2019 Patent Eligibility Guidance and MPEP § 2106.04(a)(2)(III)(C). The claims are directed to judicial exception, an abstract idea.
Applicant argues that the amended claim 1, 29, and 34 features are patent eligible under 35 U.S.C. § 101 because the claims do not recite an abstract idea (See Applicant’s response, Pg. 13).
MPEP § 2106.05(d)(II) recites “The courts have recognized the following computer functions as well understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. i. Receiving or transmitting data over a network, ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory”. MPEP § 2106.05(g) recites “Below are examples of activities that the courts have found to be insignificant extra-solution activity: Mere Data Gathering: Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989)… Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011)”.
With regards to amended claim 1, the examiner agrees that the limitation of “preoperatively receiving one or more manipulations from a user to manipulate a spatial relationship between one or more of the individual vertebrae within the interactive model to design a target post-surgical anatomical configuration for the one or more regions” is not an mental process or abstract idea, but an additional element which has of has been interpreted as receiving data to alter the anatomical model, e.g., data gathering, which has been defined by MPEP § 2106.05(d)(II) as well-understood, routine, or conventional. Therefore, this additional element is an insignificant extra-solution activity as defined and as such evidence is provide in MPEP § 2106.05(d)(II).
Therefore, the examiner has properly identified that the claims recite a feature that is well-understood,
routine, or conventional in the art and does not integrate the abstract idea into a practical application since the
feature is an insignificant extra-solution activity.
Applicant argues that amended claim 1, 29, and 34 features are patent eligible under 35 U.S.C. § 101 because the claim is integrated into a practical application through an improvement in the technology (See Applicant’s response, Pg. 14-15).
Applicant rightly asserts MPEP § 2106.4(d) which states “Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).” MPEP § 2106.05(e) states “Diamond v. Diehr provides an example of a claim that recited meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment. 450 U.S. 175, 209 USPQ 1 (1981). In Diehr, the claim was directed to the use of the Arrhenius equation (an abstract idea or law of nature) in an automated process for operating a rubber-molding press. 450 U.S. at 177-78, 209 USPQ at 4. The Court evaluated additional elements such as the steps of installing rubber in a press, closing the mold, constantly measuring the temperature in the mold, and automatically opening the press at the proper time, and found them to be meaningful because they sufficiently limited the use of the mathematical equation to the practical application of molding rubber products. 450 U.S. at 184, 187, 209 USPQ at 7, 8. In contrast, the claims in Alice Corp. v. CLS Bank International did not meaningfully limit the abstract idea of mitigating settlement risk. 573 U.S. 208, 110 USPQ2d 1976 (2014). In particular, the Court concluded that the additional elements such as the data processing system and communications controllers recited in the system claims did not meaningfully limit the abstract idea because they merely linked the use of the abstract idea to a particular technological environment (i.e., "implementation via computers") or were well-understood, routine, conventional activity recited at a high level of generality. 573 U.S. at 225-26, 110 USPQ2d at 1984-85”. Further MPEP § 2106.04(d)(II) recites “examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application”.
The examiner has provided the rational for the independent claim limitations that are being directed to a mental process in the rejection above. The additional elements of “obtaining patient data associated with one or more regions of a patient's spine”, “preoperatively receiving one or more manipulations from a user to manipulate a spatial relationship between one or more of the individual vertebrae within the interactive model to design a target post-surgical anatomical configuration for the one or more regions”, and “sending the patient-specific treatment plan to a user device for display for user review, modification, approval, and/or rejection of the target post-surgical centers of rotation” mere are insignificant extra-solution data gathering and data outputting activities, which are Well-Understood, Routine and Conventional. The additional elements of “generating an interactive virtual model of the one or more regions of the patient's spine based on the patient data, the interactive virtual model depicting (a) individual vertebrae within the one or more regions of the patient's spine, and (b) centers of rotation for corresponding vertebral segments of the patient's spine”, “A non-transitory computer-readable medium storing instructions that, when executed by a computing system, cause the computing system to perform operations for designing a patient-specific arthroplasty device” and “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” which are merely using the generic computer components and functions being used as a tool to perform the abstract idea.
Therefore, there are no additional element limitations in the independent claims which can integrate the abstract idea into a practical application by as listed in MPEP § 2106.04(d)(I). Furthermore, the examiner has also provided the rational for the dependent claim limitations that are being directed to a mental process or a mathematical concept in the rejection above. With the exception of the additional element limitations in the dependent claims which are merely using the generic computer components and functions being used as a tool to perform the abstract idea, insignificant extra-solution data gathering and data outputting activities, and merely an idea of a solution, there are no additional limitations in the rejected dependent claims which can integrate the abstract idea into a practical application.
Therefore, the examiner has properly identified that the claims recite mental process and limitations that merely use the computer as a tool to perform the abstract idea and insignificant extra-solution activities.
Applicant argues that amended claim 1, 29, and 34 features are patent eligible under 35 U.S.C. § 101 because the claim is integrated into a practical application as claim features recite significantly more, similarly to Example 3 of the 2014 Interim Eligibility Guidance (See Applicant’s response, Pg. 15-17).
MPEP § 2106.04(d)(II) recites “examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application”. MPEP § 2106.05(a) also recites “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.”
Example 3 of the 2014 Interim Eligibility Guidance improved improvement in the functioning of the computer and an improvement in another technology, namely digital image processing, which as taken as a whole, integrated the abstract ideas into a practical application. As expressing stated in the arguments on Pg. 16 with respect to the claims of the instant application, “Specifically, these claims recite an improvement in designing spinal implants by incorporating patient-specific data and user manipulations into the design and manufacturing process”. The designing of implants has been identified in the claims as a mental process, an abstract idea, which cannot provide the improvement for integration into a practical application. The improvement must come from an additional element. The examiner has provided the rational for the independent claim limitations that are being directed to a mental process in the rejection above. Furthermore, above, the examiner has identified that the additional elements of the independent claims are merely using the generic computer components and functions being used as a tool to perform the abstract idea and are merely insignificant extra-solution activities, which are Well-Understood, Routine and Conventional. Therefore, there are no additional element limitations in the independent claims which can integrate the abstract idea into a practical application by improvements to the technology and the claims do not amount to significantly more than the abstract idea. Furthermore, the examiner has also provided the rational for the dependent claim limitations that are being directed to a mental process or a mathematical concept in the rejection above. With the exception of the additional element limitations in the dependent claims which are merely using the generic computer components and functions being used as a tool to perform the abstract idea, insignificant extra-solution data gathering and data outputting activities, and merely an idea of a solution, there are no additional limitations in the rejected dependent claims which can integrate the abstract idea into a practical application or through the use of meaningful limitations to amount to significantly more than the abstract idea.
Therefore, the examiner has properly identified that the claims recite mental process and limitations that merely use the computer as a tool to perform the abstract idea and insignificant extra-solution activities.
Applicant argues that reference does not teach each and every limitation in the amend claims 1 because cited reference fails to teach “preoperatively receiving one or more manipulations from a user to manipulate a spatial relationship between one or more of the individual vertebrae within the interactive model to design a target post-surgical anatomical configuration for the one or more regions” (See Applicant’s response, Pg. 17-19).
MPEP § 2143.03 that “All words in a claim must be considered in judging the patentability of that claim against the prior art” and “Examiners must consider all claim limitations when determining patentability of an invention over the prior art.”
As mapped above in the amended claim 1, Arramon discloses “preoperatively receiving one or more manipulations from a user to manipulate a spatial relationship between one or more of the individual vertebrae within the interactive model to design a target post-surgical anatomical configuration for the one or more regions” as determining location for the selected intervertebral disc prosthesis with respect to the positions of the first and second vertebrae that allows the plates to slide over the upper and lower surfaces of the core in the anterior/posterior direction through the determination by a surgeon to reshaped vertebra to fit the implant from a result of the dysfunction of the initial intervertebral disc to determine the nature centers of rotation of the actual patient in the model pre-operatively. As the amendment states that there is a call from a user to perform this manipulation before surgery, Arramon states the plates of the implant are move in the lateral direction and rotate in addition to the surgeon having to do the reshaping of vertebrae. This is a receiving of manipulation from a user. Furthermore, since Arramon explicitly states that the target parameters are determine preoperatively (Para. 34, “the determination of the natural centers of rotation can be calculated from measurements of the actual patient in the 3D model either pre-operatively”); therefore, that the determination of the model and manipulations to achieve the desired natural centers of rotation must be done preoperatively. Additional emphasis and citations have been added to this mapping in the rejection above to the amended limitation.
Therefore, all of the limitations of the amended claim 1 are disclosed in Arramon or Turner, and the combination of these references renders the claimed invention obvious. Therefore, applicant’s arguments are not persuasive and the rejection of claim 1 as obvious over Turner in view of Arramon is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2017/0325966 A1 Capote, Cristian et al. teaches a spinal implant with plates engaging with vertebral surfaces to improve spinal disorders and pathologies and degrees of motion and rotation.
Examiner’s Note: The examiner has cited particular columns and line numbers in the reference that applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant, to fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner. In the case of amending the claimed invention, the applicant is respectfully requested to indicate the portion(s) of the specification which dictate(s) the structure relied on for the proper interpretation and also to verify and ascertain the metes and bound of the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Simeon P Drapeau whose telephone number is (571)-272-1173. The examiner can normally be reached Monday - Friday, 8 a.m. - 5 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ryan Pitaro can be reached on (571) 272-4071. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIMEON P DRAPEAU/ Examiner, Art Unit 2188
/RYAN F PITARO/ Supervisory Patent Examiner, Art Unit 2188
Prosecution Insights