DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed August 11, 2026 has been entered. Claims 1-2, 4 and 7-12 remain pending in the application.
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1, 2, 4 and 7-12 in the reply filed on August 11, 2026 is acknowledged.
Response to Arguments
Applicant’s arguments, see Remarks pages 3-5, filed August 11, 2026, with respect to the section 101 rejections have been fully considered and are persuasive. The section 101 rejections of claims 1-2, 4 and 7-12 has been withdrawn. The specific sensors within the specific implant utilizing the controllers of the implant to implement the machine learning model on and implementing within a practical application of tracking recovery and implant conditions.
Applicant’s arguments with respect to claims 1-2, 4 and 7-12 have been considered but are moot because the new ground of rejection does not rely solely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 10 is objected to because of the following informalities: claim 10 recites, “The computer-implemented method of any of claim 8,” it appears “of any” is a typo and should be deleted. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spooner et al. (US 2021/0065870 A1) (“Spooner”).
Regarding claim 1, Spooner discloses A computer-implemented method for generating a patient movement classification model, wherein the computer-implemented method comprises, as implemented by a computing system comprising one or more computer processors (Abstract and entire document):
obtaining a plurality of records from across a patient population ([0022], [0032]),
wherein a record of the plurality of records comprises kinematic data representing motion of an implant implanted in a patient of the patient population, and wherein the implant comprises a plurality of sensors configured to detect motion of the implant ([0022], [0032], FIG. 4 and [0038] and [0041]);
for individual records of the plurality of records: identifying one or more elements represented by the kinematic data; determining one or more kinematic features based on the one or more elements; and labeling the one or more kinematic features with a movement type of a plurality of movement types to generate one or more labeled kinematic features, wherein each movement type of the plurality of movement types is associated with movement of a body part; and training a machine learning model using the labeled kinematic features to classify motion of a particular implant as a particular movement type ([0022], [0032], FIG. 4 and [0038] and [0041]);
providing the machine learning model to a controller associated with the particular implant ([0037], component of sensor or wireless, see also ]0022], [0032], sensor data from particular implant/patient is modeled); and
using, by the controller, the machine learning model to process kinematic data generated by a first plurality of sensors of the particular implant to determine a movement type of the plurality of movement types, and provide the movement type for at least one of tracking patient recovery, tracking an implant condition, or managing an operational parameter of the implant to improve collection of data ([0022], [0032], FIG. 4 and [0038] and [0041], tracking range of motion recovery for example).
Regarding claim 4, Spooner discloses The computer-implemented method of claim 1, wherein the body part is associated with a body joint comprising one of a hip joint, knee joint, ankle joint, shoulder joint, elbow joint, and wrist joint (FIG. 4 and [0038]).
Regarding claim 8, Spooner discloses The computer-implemented method of claim 1, wherein a first sensor of the plurality of sensors comprises a gyroscope oriented relative to the body part and configured to provide, as kinematic data, a signal representing angular velocity about a first axis relative to the body part ([0041]).
Regarding claim 9, Spooner discloses The computer-implemented method of claim 1, wherein a first sensor of the plurality of sensors comprises an accelerometer oriented relative to the body part and configured to provide, as kinematic data, a signal representing acceleration along a first axis relative to the body part ([0041]).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Spooner in view of Amit et al. (US 11,006,860 B1) (“Amit”).
Regarding claim 2, Spooner discloses The computer-implemented method of claim 1, Spooner fails to disclose wherein identifying one or more elements represented by the kinematic data comprises: representing the kinematic data as a time-series waveform, and identifying a set of fiducial points in the time-series waveform, wherein the one or more elements correspond to the set of fiducial points.
However, in the same field of endeavor, Amit teaches wherein identifying one or more elements represented by the kinematic data comprises: representing the kinematic data as a time-series waveform, and identifying a set of fiducial points in the time-series waveform, wherein the one or more elements correspond to the set of fiducial points (See at least FIG. 2 and associated paragraphs, see at least Col. 15 lines 6-26, “The results shown in FIG. 7 demonstrate the occurrences of strides according to the values of two different gait kinematic parameters as axes, being foot on ground duration (vertical axis) and velocity (horizontal axis).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Spooner to include wherein identifying one or more elements represented by the kinematic data comprises: representing the kinematic data as a time-series waveform, and identifying a set of fiducial points in the time-series waveform, wherein the one or more elements correspond to the set of fiducial points as taught by Amit to show a visual representation (Col. 15 lines 20-26).
Regarding claim 7, Spooner discloses The computer-implemented method of claim 1, Spooner fails to disclose further comprising: representing each kinematic data included in the plurality of records as one of a time-series waveform or a spectral distribution graph; and
applying a clustering algorithm to a plurality of time-series waveforms or spectral distribution graphs to automatically separate the plurality of time-series waveforms or spectral distribution graphs into a plurality of clusters;
wherein labeling the one or more kinematic features with a movement type is based determining that the one or more kinematic features are associated with a particular cluster of the plurality of clusters.
However, in the same field of endeavor, Amit teaches further comprising: representing each kinematic data included in the plurality of records as one of a time-series waveform or a spectral distribution graph (See at least FIG. 2 and associated paragraphs, see at least Col. 15 lines 6-26, “The results shown in FIG. 7 demonstrate the occurrences of strides according to the values of two different gait kinematic parameters as axes, being foot on ground duration (vertical axis) and velocity (horizontal axis).”); and
applying a clustering algorithm to a plurality of time-series waveforms or spectral distribution graphs to automatically separate the plurality of time-series waveforms or spectral distribution graphs into a plurality of clusters (See at least FIG. 2 and associated paragraphs, see at least Col. 15 lines 6-26, “Each stride shape is associated with one stride type mentioned in the matrix of FIG. 6, for example a point associated with a walking stride is marked by a circle and a point associated with a running stride is marked by a cross. Multiple clusters are seen, including two significant clusters, cluster 704 indicating lower velocity and longer foot on ground times, which are typical of walking, and cluster 708 indicating higher velocity, for example 2-8 meter per second, and shorter foot on ground times, which are typical of running, wherein the stride types associated with these two clusters are consistent with the dominant types on the diagonal of the confusion matrix, being forward_walk and forward_run.”);
wherein labeling the one or more kinematic features with a movement type is based determining that the one or more kinematic features are associated with a particular cluster of the plurality of clusters (See at least FIG. 2 and associated paragraphs, see at least Col. 15 lines 6-26, “Each stride shape is associated with one stride type mentioned in the matrix of FIG. 6, for example a point associated with a walking stride is marked by a circle and a point associated with a running stride is marked by a cross. Multiple clusters are seen, including two significant clusters, cluster 704 indicating lower velocity and longer foot on ground times, which are typical of walking, and cluster 708 indicating higher velocity, for example 2-8 meter per second, and shorter foot on ground times, which are typical of running, wherein the stride types associated with these two clusters are consistent with the dominant types on the diagonal of the confusion matrix, being forward_walk and forward_run.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Spooner to include further comprising: representing each kinematic data included in the plurality of records as one of a time-series waveform or a spectral distribution graph; and applying a clustering algorithm to a plurality of time-series waveforms or spectral distribution graphs to automatically separate the plurality of time-series waveforms or spectral distribution graphs into a plurality of clusters; wherein labeling the one or more kinematic features with a movement type is based determining that the one or more kinematic features are associated with a particular cluster of the plurality of clusters as taught by Amit to show a visual representation (Col. 15 lines 20-26).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Spooner in view of Amit in further view of Zhang Y, Yan W, Yao Y, Ahmed JB, Tan Y, Gu D. Prediction of Freezing of Gait in Patients With Parkinson's Disease by Identifying Impaired Gait Patterns. IEEE Trans Neural Syst Rehabil Eng. 2020 Mar;28(3):591-600. doi: 10.1109/TNSRE.2020.2969649. Epub 2020 Jan 27. PMID: 31995497. (“Zhang”, submitted in July 25, 2023 IDS).
Regarding claim 10, Spooner as modified discloses The computer-implemented method of claim 8, Spooner as modified fails to disclose wherein the first axis is one axis of a three-dimensional implant coordinate system comprising a second axis and a third axis, and wherein obtaining the plurality of records comprises: obtaining from a second sensor of the plurality of sensors, as kinematic data, a signal representing one of: angular velocity about the second axis relative to the body part, or acceleration along the second axis relative to the body part; and obtaining from a third sensor of the plurality of sensors, as kinematic data, a signal representing one of: angular velocity about the third axis relative to the body part, or acceleration along the third axis relative to the body part.
However, in the same field of endeavor, Zhang teaches wherein the first axis is one axis of a three-dimensional implant coordinate system comprising a second axis and a third axis, and wherein obtaining the plurality of records comprises: obtaining from a second sensor of the plurality of sensors, as kinematic data, a signal representing one of: angular velocity about the second axis relative to the body part, or acceleration along the second axis relative to the body part; and obtaining from a third sensor of the plurality of sensors, as kinematic data, a signal representing one of: angular velocity about the third axis relative to the body part, or acceleration along the third axis relative to the body part (Page 592, last paragraph – page 593 discussing the sensors and coordinate system, kinematic data, angular velocity measurements).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Spooner to include wherein the first axis is one axis of a three-dimensional implant coordinate system comprising a second axis and a third axis, and wherein obtaining the plurality of records comprises: obtaining from a second sensor of the plurality of sensors, as kinematic data, a signal representing one of: angular velocity about the second axis relative to the body part, or acceleration along the second axis relative to the body part; and obtaining from a third sensor of the plurality of sensors, as kinematic data, a signal representing one of: angular velocity about the third axis relative to the body part, or acceleration along the third axis relative to the body part as taught by Zhang to achieve higher accuracy (Abstract).
Regarding claim 11, Spooner as modified discloses The computer-implemented method of claim 10, further comprising, Spooner as modified fails to disclose prior to labeling the one or more kinematic features, combining two or more of the respective signals representing angular velocity or acceleration about the first axis, the second axis, and the third axis.
However, in the same field of endeavor, Zhang teaches prior to labeling the one or more kinematic features, combining two or more of the respective signals representing angular velocity or acceleration about the first axis, the second axis, and the third axis (Page 592, last paragraph – page 593 discussing the sensors and coordinate system, kinematic data, angular velocity measurements).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Spooner to include prior to labeling the one or more kinematic features, combining two or more of the respective signals representing angular velocity or acceleration about the first axis, the second axis, and the third axis as taught by Zhang to achieve higher accuracy (Abstract).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Spooner in view of Amit in further view of Zhang in further view of Joglekar (US 2010/0135553 A1) (“Joglekar”).
Regarding claim 12, Spooner as modified discloses The computer-implemented method of claim 10, Spooner as modified fails to disclose further comprising: calculating a transverse plane skew angle between corresponding transverse planes of the implant coordinate system and an anatomical coordinate system associated with the body part;
responsive to a transverse plane skew angle that is less than a threshold value, determining that the implant coordinate system is aligned with the anatomical coordinate system; and responsive to a transverse plane skew angle that is above the threshold value, determining that the implant coordinate system is not aligned with the anatomical coordinate system.
However, in the same field of endeavor, Joglekar teaches further comprising: calculating a transverse plane skew angle between corresponding transverse planes of the implant coordinate system and an anatomical coordinate system associated with the body part ([0249] discussing skew angle between coordinate systems);
responsive to a transverse plane skew angle that is less than a threshold value, determining that the implant coordinate system is aligned with the anatomical coordinate system; and responsive to a transverse plane skew angle that is above the threshold value, determining that the implant coordinate system is not aligned with the anatomical coordinate system ([0087 – 0089] discussing threshold and coordinates and images, both thresholds discussed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Spooner to include further comprising: calculating a transverse plane skew angle between corresponding transverse planes of the implant coordinate system and an anatomical coordinate system associated with the body part; responsive to a transverse plane skew angle that is less than a threshold value, determining that the implant coordinate system is aligned with the anatomical coordinate system; and responsive to a transverse plane skew angle that is above the threshold value, determining that the implant coordinate system is not aligned with the anatomical coordinate system as taught by Joglekar to verify configuration (abstract).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mokete (US 2021/0378841 A1) (“Mokete”).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH A TOMBERS/ Examiner, Art Unit 3791
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