DETAILED ACTION
Applicant’s arguments, filed 06/10/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Applicant has amended their claims, filed 06/10/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant canceled claim 13. Claims 1-12 and 14-22 are pending and hereby under examination.
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 .
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12, line 9, “algorithms” should be “algorithm”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 and 14-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-12 and 14-22 recite having “algorithms”, “selecting an algorithm”, and “receiving data … utilizing the algorithm”. However, there is no disclosure as to what the algorithm is, what the algorithm does, and/or what equation(s) the algorithm uses to make a measurement or determination of a value. Applicant’s specification paragraphs 0139 – 0144 refer to generic “algorithms” such as kinematic and classification algorithms in a “software package”; however, there is no clear step or method on how these algorithms are used and what they are. How does the classification algorithm determine which size the implant is? How are the algorithms changed, calibrated, or selected based on sizes of the implants? How do the sizes of the implants inform the algorithm to make further calculations or to decide what algorithm is used to make further calculations? How is the kinematic information calculated? Additionally, are these algorithms machine learning algorithms or are they predetermined equations? As such, it appears the limitations directed towards selecting an algorithm and using the algorithm do not have proper written description support in the instant specification.
For examination purposes, the claims will be interpreted such that an algorithm, equation, or model is selected from a plurality of algorithms, equations, or models. This selected algorithm, equation, or model is “calibrated” by being set for a specific set of given parameters.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 and 14-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1, 12, and 19, it is unclear what the algorithm is, how one algorithm is chosen over another, and how kinematic information is determined based on the first and second information.
What calculations or equations does the algorithm use to make these determinations? Are they predetermined equations or machine learning algorithms? How is the algorithm “calibrated” based on the information - does the algorithm change or are there multiple algorithms to choose from? It if changes, how does it change?
For examination purposes, the claims will be interpreted such that an algorithm, equation, or model is selected from a plurality of algorithms, equations, or models. This selected algorithm, equation, or model is “calibrated” by being set for a specific set of given parameters and is used to calculate kinematic information.
Claims 2-11, 14-18, and 20-22 are also rejected due to their dependence on claims 1, 12, and 19.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Analysis of independent claim 1:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a computer implemented method, which describes one of the four statutory categories of patentable subject matter, i.e., a method. Therefore, further consideration is necessary regarding claims.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 1 recites an abstract idea. In particular, the claims generally recite
the following:
selecting an algorithm from a plurality of algorithms based on the first and second information;
the selected algorithm is calibrated based on the first information and the second information to determine kinematic information of the first and second implants.
The elements in claim 1 are drawn to an abstract idea since it is directed towards mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).
“selecting an algorithm from a plurality of algorithms based on the first and second information” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably review characteristics of an implant and select an algorithm from a plurality of algorithms to further determine data of the implants. There is nothing to suggest an undue level of complexity in “selecting an algorithm from a plurality of algorithms based on the first and second information”.
“the selected algorithm is calibrated based on the first information and the second information to determine kinematic information of the first and second implants” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably review characteristics of an implant and select one algorithm (i.e., calibrate it) from a plurality of algorithms to further determine data from the implants. There is nothing to suggest an undue level of complexity in “the selected algorithm is calibrated based on the first information and the second information to determine kinematic information of the first and second implants”
Prong Two: Claim 1 does not recite additional elements that integrate the exception into a practical application. Therefore, the claims are "directed to" the abstract idea. The additional elements merely:
Add insignificant extra-solution activity (the pre-solution activity of: using generic data gathering components (e.g., "receiving, by a processor, first information related to a first implant, the first information including a size of the first implant" and "receiving, by the processor, first information related to a first implant, the second information including a size of the second implant"); the post-solution activity of: (e.g. “receiving, at the processor, data from the first and second implants utilizing the selected algorithm”)).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 1 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to implementing the abstract ideas on generic processing components, the pre-solution activity of using generic data-gathering components, and generic post-solution activities, which merely facilitate the abstract idea.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, “an implant” as disclosed in the Applicant’s specification is “A joint implant according to this aspect, may include a first implant coupled to a first bone of a joint and a second implant coupled to a second bone of the joint” (Paragraph 0015), “knee joint implant” (Paragraph 0097), “a spinal implant” (Paragraph 0120), “hip implant” (Paragraph 0121), and “shoulder implant” (Paragraph 0126). Further, a “processor” is disclosed as “An onboard processor 250 such as a microcontroller unit ("MCU") is used to read sensors 244 and 236 and process results for transmission to an external source. This data can be retrieved, processed, and transferred by the MCU via antenna 222 continuously, at predefined intervals, or when certain alkalinity, pressure, and/or temperature thresholds, or any combinations thereof, are detected” (Paragraph 0104).
These additional elements do not qualify as significantly more because these limitations are simply appending well understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well understood, routine and conventional activity previously known in the industry (see Electric PowerGroup, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014); SAP Am. v. lnvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements include a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of dependent claims 2-11:
Claims 2-11 recite limitations in addition to the abstract idea: they merely
Further describe the abstract idea (“wherein the algorithm is included in a software package in communication with the reader” (claim 7)),
Further describe the pre-solution activity (“wherein the first information includes a position of the first implant and the second information includes a position of the second implant” (claim 2), “wherein the first implant is implanted on a first bone and the second implant is implanted on a second bone” (claim 3), “wherein the first implant includes a marker and the second implant includes a reader” (claim 4), and “wherein the marker is a magnet and the reader is a magnetic sensor” (claim 5), “wherein the magnetic sensor is a Hall sensor assembly including at least one Hall sensor” (claim 6), “wherein the first and second information is manually inputted” (claim 9), “wherein the information as to the first and second sizes is received from an RFID chip” (claim 10), and “wherein the first and second information is determined by magnetic readings” (claim 11)), and
Further describe the post-solution activity (“wherein the data includes a temperature reading from at least one of the first and second implants” (claim 8)).
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. The result of the abstract idea does not cause the computing device and/or application to perform differently.
Therefore, claims 1-11 are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-7, 9, 11-12, 14-17, 19-20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over DiSilvestro (US 20050010301) and McKinnon (US 20200275976).
Regarding claim 1, DiSilvestro discloses a method of determining performance of a joint implant, the method comprising the steps of:
receiving, by a processor (Paragraphs 0065/0070, sensor 28 connected to transmitter 36 on PCB 34 which are connected to interpretation device 42), first information (Paragraph 0059, measuring magnetic flux density between the magnet 26 and Hall effect transducer 28) related to a first implant (Fig. 1, femoral component 24), the first information including a size of the first implant (Paragraph 0059, measuring magnetic flux density between the magnet 26 and Hall effect transducer 28; Paragraph 0072 and Fig. 2, wherein the joint space d3 and thickness of the bearing d4 can be calculated and d1 and d2 are known);
receiving, by the processor, second information (Paragraph 0059, measuring magnetic flux density between the magnet 26 and Hall effect transducer 28; Paragraph 0072 and Fig. 2, wherein the joint space d3 and thickness of the bearing d4 can be calculated and d1 and d2 are known) related to a second implant (Fig. 1, tibial bearing 16), the second information including a size of the second implant (Paragraph 0059, measuring magnetic flux density between the magnet 26 and Hall effect transducer 28; Paragraph 0072 and Fig. 2, wherein the joint space d3 and thickness of the bearing d4 can be calculated and d1 and d2 are known).
While DiSilvestro suggests selecting an algorithm based on the first and second information (Paragraph 0095, a suitable algorithm could be used to determine a distance corresponding with this perturbation in the magnetic field”), DiSilvestro fails to disclose selecting an algorithm from a plurality of algorithms, and calibrating the algorithm to determine kinematic information of the implants. DiSilvestro and McKinnon are in the same field of knee prosthetics. McKinnon teaches a method of optimizing a knee arthroplasty, wherein patient-specific kinetic and kinematic response values are generated based on specific parameters (Abstract). After implantation, specific parameters are received about the implants (Paragraph 0166, “positioning information for the femoral and tibial components including, without limitation, rotational alignment (e.g., varus/valgus rotation, external rotation, flexion rotation for the femoral component, posterior slope of the tibial component), resection depths (e.g., varus knee, valgus knee), and implant type, size and position”). Based on these received parameters, a set of equations is retrieved from an equation database (Paragraph 0180), wherein each equation dataset provides kinetic and kinematic response data for the specific group of parameters (Paragraph 0181; Figs. 5A-F). Per the 112(a) and 112(b) rejections and claim interpretation above, the calibration of the algorithm is interpreted as an algorithm being chosen based off a set of parameters. The claim only requires the selected algorithm to be “calibrated based on the first information and the second information”; thus, calibration can be interpreted as narrowing an algorithm given a specific set of parameters. As the claim requires the algorithm to be selected from a plurality of algorithms based on the first and second information, Examiner interprets this selection as calibrating (i.e., narrowing) the algorithm to one specific algorithm based on the implant size data.
As DiSilvestro is concerned with measuring properties between the implants, McKinnon teaches an equation database to select a set of equations for kinematic responses that are specific to the parameters of the implant specific to the patient, such as implant size and position. McKinnon discusses that using different equations based on different parameters yields patient-specific kinematic and kinetic response values. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of DiSilvestro with the equation database as taught by McKinnon, the benefit in yielding patient-specific response data base on patient-specific parameters.
Regarding claim 2, the combination of DiSilvestro and McKinnon disclose the method according to claim 1. DiSilvestro further discloses wherein the first information includes a position of the first implant and the second information includes a position of the second implant (Paragraph 0055, “Changes in the relative position of the implant components on both sides of the joint space can also be determined by including signal sources on both sides of the joint space within the body and distance references at at least two additional locations, such as at external locations. The distance between each signal source and the distance reference can be used to determine changes in the joint space”; Fig. 2 and paragraph 0072, wherein the distance d3 between the signal source 26 and sensor 28 will vary and is measured. Examiner interprets this distance to correspond to the relative positions between the implants.
Regarding claim 3, the combination of DiSilvestro and McKinnon disclose the method according to claim 1. DiSilvestro further discloses wherein the first implant is implanted on a first bone and the second implant is implanted on a second bone (Fig. 1, tibial bearing 16 and femoral component 24).
Regarding claims 4-6, the combination of DiSilvestro and McKinnon disclose the method according to claim 1. DiSilvestro further discloses wherein the first implant includes a marker wherein the marker is a magnet (Fig. 1, signal source 26; Paragraph 0058, “the signal source 26 comprises a permanent magnet”), and the second implant includes a reader, wherein the reader is a magnetic sensor such as a Hall sensor assembly including at least one Hall sensor (Fig. 1, sensor 28; Paragraph 0059, “the sensor 28 is a Hall effect transducer”).
Regarding claim 7, the combination of DiSilvestro and McKinnon disclose the method according to claim 4. DiSilvestro further discloses wherein the algorithm is included in a software package in communication with the reader (Paragraph 0062, wherein the system includes components such as a transmitter; Paragraph 0092, wherein the circuit includes programming tools for analysis and display of the implant data).
Regarding claim 9, the combination of DiSilvestro and McKinnon disclose the method according to claim 1. DiSilvestro further discloses wherein the first and second information is manually inputted (Paragraph 0074, wherein the surgeon/technician would determine the base measurement for the distance d3).
Regarding claim 11, the combination of DiSilvestro and McKinnon disclose the method according to claim 1. DiSilvestro further discloses wherein the first and second information is determined by magnetic readings (Paragraph 0097, wherein the Hall sensor measures the distances).
Regarding claim 12, DiSilvestro discloses a joint replacement system comprising:
a first implant having a marker (Fig. 1, signal source 26 comprising a magnet affixed to distal femoral component 24);
a second implant having a reader to detect the marker (Fig. 1, sensor 28 comprising a Hall effect transducer affixed to the proximal tibial component 18), and
a processor in communication with the second implant (Fig. 2 and paragraphs 0065/0070, sensor 28 connected to transmitter 36 on PCB 34 which are connected to interpretation device 42).
While DiSilvestro suggests selecting an algorithm based on the first and second information (Paragraph 0095, a suitable algorithm could be used to determine a distance corresponding with this perturbation in the magnetic field”), DiSilvestro fails to disclose selecting an algorithm from a plurality of algorithms based on the sizes. DiSilvestro and McKinnon are in the same field of knee prosthetics. McKinnon teaches a method of optimizing a knee arthroplasty, wherein patient-specific kinetic and kinematic response values are generated based on specific parameters (Abstract). After implantation, specific parameters are received about the implants (Paragraph 0166, “positioning information for the femoral and tibial components including, without limitation, rotational alignment (e.g., varus/valgus rotation, external rotation, flexion rotation for the femoral component, posterior slope of the tibial component), resection depths (e.g., varus knee, valgus knee), and implant type, size and position”). Based on these received parameters, a set of equations is retrieved from an equation database (Paragraph 0180), wherein each equation dataset provides kinetic and kinematic response data for the specific group of parameters (Paragraph 0181; Figs. 5A-F). ). Per the 112(a) and 112(b) rejections and claim interpretation above, the calibration of the algorithm is interpreted as an algorithm being chosen based off a set of parameters. The claim only requires the selected algorithm to be “calibrated based on the first information and the second information”; thus, calibration can be interpreted as narrowing an algorithm given a specific set of parameters. As the claim requires the algorithm to be selected from a plurality of algorithms based on the first and second information, Examiner interprets this selection as calibrating (i.e., narrowing) the algorithm to one specific algorithm based on the implant size data.
As DiSilvestro is concerned with measuring properties between the implants, McKinnon teaches an equation database to select a set of equations for kinematic responses that are specific to the parameters of the implant specific to the patient, such as implant size and position. McKinnon discusses that using different equations based on different parameters yields patient-specific kinematic and kinetic response values. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of DiSilvestro with the equation database as taught by McKinnon, the benefit in yielding patient-specific response data base on patient-specific parameters.
Regarding claim 14, the combination of DiSilvestro and McKinnon disclose the system of claim 12. DiSilvestro further discloses wherein the first implant is a femoral implant and the second implant is a tibial implant (Fig. 1, femoral component 24 and tibial component 18).
Regarding claims 15-16, the combination of DiSilvestro and McKinnon disclose the system of claim 12. DiSilvestro further discloses wherein the marker is a magnet (Fig. 1, signal source 26; Paragraph 0058, “the signal source 26 comprises a permanent magnet”) and the reader is a magnetic sensor, wherein the magnetic sensor is a Hall sensor assembly including at least one Hall sensor (Fig. 1, sensor 28; Paragraph 0059, “the sensor 28 is a Hall effect transducer”).
Regarding claim 17, the combination of DiSilvestro and McKinnon disclose the system of claim 12. DiSilvestro further discloses wherein the processor receives kinematic information from the reader (Paragraph 0070, wherein the data interpretation device may perform calculations necessary to convert data to a distance).
Regarding claim 19, DiSilvestro discloses a surgical procedure comprising the steps of:
implanting a first implant on a first bone, the first implant including a marker (Fig. 1, signal source 26 comprising a magnet affixed to distal femoral component 24);
implanting a second implant on a second bone, the second implant including a reader, the reader configured to detect the marker (Fig. 1, sensor 28 comprising a Hall effect transducer affixed to the proximal tibial component 18);
connecting the reader with a processor (Fig. 2 and paragraphs 0065/0070, sensor 28 connected to transmitter 36 on PCB 34 which are connected to interpretation device 42);
providing the processor with a first size of the first implant and a second size of the second implant (Paragraph 0059, measuring magnetic flux density between the magnet 26 and Hall effect transducer 28; Paragraph 0072 and Fig. 2, wherein the joint space d3 and thickness of the bearing d4 can be calculated and d1 and d2 are known); and
While DiSilvestro suggests selecting an algorithm based on the first and second information (Paragraph 0095, a suitable algorithm could be used to determine a distance corresponding with this perturbation in the magnetic field”), DiSilvestro fails to disclose selecting an algorithm from a plurality of algorithms based on the sizes. DiSilvestro and McKinnon are in the same field of knee prosthetics. McKinnon teaches a method of optimizing a knee arthroplasty, wherein patient-specific kinetic and kinematic response values are generated based on specific parameters (Abstract). After implantation, specific parameters are received about the implants (Paragraph 0166, “positioning information for the femoral and tibial components including, without limitation, rotational alignment (e.g., varus/valgus rotation, external rotation, flexion rotation for the femoral component, posterior slope of the tibial component), resection depths (e.g., varus knee, valgus knee), and implant type, size and position”). Based on these received parameters, a set of equations is retrieved from an equation database (Paragraph 0180), wherein each equation dataset provides kinetic and kinematic response data for the specific group of parameters (Paragraph 0181; Figs. 5A-F). ). Per the 112(a) and 112(b) rejections and claim interpretation above, the calibration of the algorithm is interpreted as an algorithm being chosen based off a set of parameters. The claim only requires the selected algorithm to be “calibrated based on the first information and the second information”; thus, calibration can be interpreted as narrowing an algorithm given a specific set of parameters. As the claim requires the algorithm to be selected from a plurality of algorithms based on the first and second information, Examiner interprets this selection as calibrating (i.e., narrowing) the algorithm to one specific algorithm based on the implant size data.
As DiSilvestro is concerned with measuring properties between the implants, McKinnon teaches an equation database to select a set of equations for kinematic responses that are specific to the parameters of the implant specific to the patient, such as implant size and position. McKinnon discusses that using different equations based on different parameters yields patient-specific kinematic and kinetic response values. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of DiSilvestro with the equation database as taught by McKinnon, the benefit in yielding patient-specific response data base on patient-specific parameters.
Regarding claim 20, the combination of DiSilvestro and McKinnon disclose the method of claim 19. DiSilvestro further discloses wherein the first and second sizes are manually inputted (Paragraph 0074, wherein the surgeon/technician would determine the base measurement for the distance d3).
Regarding claim 22, the combination of DiSilvestro and McKinnon disclose the method of claim 19. DiSilvestro further discloses wherein the providing step includes receiving the first and second sizes from magnetic readings (Paragraph 0097).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over DiSilvestro (US 20050010301) and McKinnon (US 20200275976) as applied to claim 1 above, and further in view of Morgan (US 20060052782).
Regarding claim 8, the combination of DiSilvestro and McKinnon disclose the method of claim 1 above. The combination DiSilvestro fails to disclose calculating a temperature reading from at least one of the first and second implants.
DiSilvestro, McKinnon, and Morgan are in the same field of implants. Morgan teaches an orthopedic implant with sensors (Abstract), wherein the sensors measure temperature of the implant (Paragraph 0030). The temperature readings along the implant determine whether the surrounding tissue is infected following implantation. As the combination of DiSilvestro is concerned with measuring kinematics of the implant and determining the proper equations for patient-specific data collection, Morgan further expands on implant measurements by taking the temperature surrounding the tissue after implantation to monitor for infection. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of DiSilvestro and McKinnon to incorporate measuring the temperature as taught by Morgan, the benefit being monitoring for infection post-implantation.
Claims 10, 18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over DiSilvestro (US 20050010301) and McKinnon (US 20200275976) as applied to claims 1, 12, and 19, respectively, above, and further in view of Berger (US 20050247319).
Regarding claims 10, 18, and 21, the combination of DiSilvestro and McKinnon discloses the system and method of claims 1, 12, and 19 above. DiSilvestro further discloses a RF transmitter (Paragraph 0052). However, the combination fails to disclose an RFID chip for holding information regarding the sizes of the implants.
DiSilvestro, McKinnon, and Berger are in the same field of implants. Berger teaches a medical implant device wherein a RFID tag is affixed on a medical implant (Paragraph 0032) and carries information related to dimensions and measurements of the implant (Paragraph 0013). Berger discusses including an RFID tag is useful for automatic device identification, monitoring, and patient information. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant of DiSilvestro and McKinnon with the RFID tag of Berger to automatically identify information such as implant dimensions and measurements.
Response to Arguments
Applicant’s arguments, see page 6, filed 06/10/2026, with respect to the claim objection have been fully considered and are persuasive. Applicant has corrected the typographical error. The objection of the claim has been withdrawn. However, a new objection to the claims has been applied.
Applicant’s arguments, see pages 6-7, filed 06/10/2026, with respect to the 35 U.S.C. §112(a) rejection have been fully considered but are not persuasive. Applicant asserts that paragraphs 0139 and 0141-0142 describe in specific terms what the algorithms do and how they are selected and calibrated based on the sizes of the first and second implants. Examiner disagrees.
The instant application broadly refers to algorithms, such as a kinematics algorithm and a classification algorithm. Applicant does not define what these algorithms are, merely that they are algorithms configured to “output joint kinematics” (Paragraph 0142) and “takes magnetic data from this motion and determines which size implant is used” (Paragraph 0143). Further, the kinematic algorithm is “modified to match the implant size by the classification algorithm” (Paragraph 0143).
However, it is not clear what the algorithm is. An algorithm may broadly refer to machine learning algorithms, which Applicant does not disclose in the specification, or refer to predetermined equations that change depending on the input size, which Applicant also does not disclose. Further, the claims broadly recite “selecting … an algorithm from a plurality of algorithms”, however, there isn’t one specific algorithm disclosed nor is there any disclosure of how one algorithm is different than another.
Further, claim 12 recites that the processor calculates kinematic information using the selected algorithm. How does it calculate the kinematic information? What data is being input into the equation, how is it manipulated, and what is output? The specification merely states that the algorithm outputs joint kinematics. As such, it appears the limitations directed towards selecting an algorithm and using the algorithm do not have proper written description support in the instant specification. As Applicant has amended claim 19 to include the limitation of determining kinematic information using an algorithm, the rejection has been updated to include claims 19-22.
Applicant’s arguments, see pages 7-8, filed 06/10/2026, with respect to the 35 U.S.C. §112(b) rejections have been fully considered and are partially persuasive.
The preamble of claim 1 has been amended to remove “performing surgery” to “determining performance of a joint implant”.
The method of claim 1 has been amended to recite structure capable of performing the method.
The system of claim 12 has been amended to recite what the system does (i.e., calculate kinematic information of the implants.
Claim 19 has been amended to remove the step of “reviewing data” to recite “determining … kinematic information”. Thus, these rejections of the claims have been withdrawn.
Applicant asserts that amended claim 12 now recites that the processor is configured to select an algorithm from a plurality of algorithms based on size of the implants, and calculates kinematic information of the first and second implants, which defines the operation of the system and its relationship to the marker and reader. Examiner disagrees.
As the specification fails to disclose what the type of algorithms are used (e.g., machine learning algorithm or predetermined equations), it is unclear how the algorithms perform their functions. How is the algorithm calibrated based on the first and second information? How is the selected algorithm different from the plurality of algorithms? How is kinematic information generated or calculated? As such, the rejection of claims 12 and 14-18 remains. The rejection has been updated to include claims 1-11 and 19-22 due to the amendments.
Applicant’s arguments, see pages 8-9, filed 06/10/2026, with respect to the 35 U.S.C. §101 rejections have been fully considered but are not persuasive.
Applicant asserts that by amending the claims to include “selecting an algorithm from a plurality of algorithms” and “calibrating that algorithm based on the size”, the claims are not directed to an abstract idea that can be performed in the human mind or with pen and paper (a mental process). Examiner respectfully disagrees.
The claims broadly recite that an algorithm is selected from a plurality of algorithms based on implant size. One of ordinary skill, with the aid of pen and paper or a generic computer, would be able to select an algorithm given a set of parameters. There is no undue complexity in this step. Further, the “calibration” step appears to be directed towards choosing one algorithm from a plurality of algorithms based on specific parameters rather than modifying an algorithm given certain parameters. As Applicant does not disclose how this calibration step is performed, the claim is interpreted such that “calibration” is equated to selection of a specific algorithm given a specific set of parameters. As such, these steps are directed towards mental processes.
Applicant further asserts that the judicial exception is integrated into a practical application by the calibration step. Examiner disagrees.
While it may be true that the claimed method may provide an improvement to implant tracking, the improvement cannot rely solely within the judicial exception. That is, the judicial exception alone cannot provide the improvement.
The judicial exception, as described above, is identified as the abstract ideas of selecting and calibrating an algorithm. Applicant asserts that the improvement of the method is by selecting and calibrating an algorithm to improve monitoring of joint-implant kinematics; however, this improvement is the abstract idea, and the abstract idea itself is not an improvement in the technology (see MPEP 2106.05(a)). Therefore, Applicant’s argument is found not persuasive. The rejection above has been updated to reflect the amendments made to the claims.
Applicant’s arguments, see pages 9-10, filed 06/10/2026, with respect to the rejection(s) of claim(s) 1-7, 9, 11, 19-20, and 22 under 35 U.S.C. §102(a)(1) and claims 12-17 under 35 U.S.C. §103 have been fully considered and are persuasive. Examiner agrees that DiSilvestro does not teach the limitation of selecting an algorithm from a plurality of algorithms. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of McKinnon. See above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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