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 June 1, 2026 has been entered. Claims 1-20 are pending.
In light of Applicant’s amendments, a new grounds of rejection under 35 U.S.C. 103 is presented.
Response to Argument
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 1, 5-9, 11-13, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over:
Stein et al. (US 20140171754 A1) (disclosed by Applicant) (hereinafter – Stein) in view of
Gross et al. (US 20210369471 A1) (disclosed by Applicant) (hereinafter – Gross) in further view of
Leuthardt et al. – (US 20210361948 A1) (hereinafter – Leuthardt).
Re. Claim 1: Stein teaches a joint implant (Title; Abstract)
comprising:
a first implant for coupling to a first bone of a joint (Fig. 1: femoral prosthetic component 104; Fig. 28: one of the hip joint prosthetic components shown); and
a second implant for coupling to a second bone of the joint adjacent the first implant (Fig. 1: tibial prosthetic component 106; Fig. 27; Fig. 28: the other of the hip joint prosthetic components shown; see similar structures in Figs. 29, 31, 33, 38, 40),
the second implant including:
a plurality of sensors configured to measure data (Fig. 27: load pads 2722; Fig. 28: capacitors 2814; Fig. 29: capacitors 2906; Figs. 31, 34, 37, 40: load pads 3108; Fig. 37: temperature sensor 3704, pH sensor 3706, photo-diode array 3710); and
a processor operatively coupled to the plurality of sensors and adapted to receive the data from the sensors (Fig. 28: electronic circuitry 2812, as described at Paragraph 0203: “The electronic circuitry 2812 can further include a power source, power management circuitry, conversion circuitry, digital logic, processors, multiple input/output circuitry, and communication circuitry;” additionally or alternatively, see communication with remote system (illustrated as a laptop computer) at Figs. 28, 29, 38; see any processing component in Figs. 41-42).
Stein does not teach the invention wherein the processor is adapted to communicate with a neural network.
Gross teaches analogous art in the technology of analyzing implant sensor signals (Abstract). Gross further teaches the invention wherein the processor is adapted to communicate with a neural network (Paragraph 0455: “As described elsewhere in this patent application, one can use one or more deterministic algorithms, or one or more machine-learning algorithms (e.g., neural networks), to characterize the instability and to suggest one or more procedures for remediating the instability;” similarly recited in Paragraphs 0465, 0475,0764).
It would have been obvious to one having skill in the art before the effective filing date to have modified Stein to have the processor adapted to communicate with a neural network as taught by Gross, the motivation being that the neural network may process sensor data to identify implant sensor instability, degradation, a cause thereof, as well as determine a suitable physical therapy in to remediate detected instability from sensor signals (see cited portions).
Stein as modified by Gross does not teach the invention wherein the processor is adapted to communicate with a channel detector configured to exclude a first portion of the data received from the processor and output a second portion of the data, the processor being configured to mark the first portion of the data with a data tag identifying the first portion of the data as inaccurate data, and the channel detector being configured to exclude the first portion of the data based on the data tag.
Leuthardt teaches analogous art in the technology of implantable devices having multiple sensors (Abstract). Leuthardt further teaches the invention wherein the processor is adapted to communicate with a channel detector configured to exclude a first portion of the data received from the processor and output a second portion of the data, the processor being configured to mark the first portion of the data with a data tag identifying the first portion of the data as inaccurate data, and the channel detector being configured to exclude the first portion of the data based on the data tag (Paragraph 0036; “The data is processed by the one or more processor/controllers, and/or by a processor included in the portable communication device and/or by the at least one remote processor for modulating and/or controlling the stimulating of one or more brain regions to treat the mood disorder;” Paragraph 0165: “Signals recorded from the system are processed in the following fashion. Channels with abnormal amplitude (e.g. >±1000 mV) or power spectra (e.g. harmonic noise) are flagged and removed from further analysis”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Stein as modified by Gross to include the data flagging and exclusion process as taught by Leuthardt, the motivation being that doing so removes noise and/or abnormalities in the final set of signals for analysis (Paragraph 0165).
Re. Claim 5: Stein as modified by Gross and Leuthardt teaches the invention according to claim 1. Leuthardt, in teaching further detail regarding the modification, further teaches the invention wherein the second portion of the data is accurate data (see citation of rejection of claim 1: flagging abnormal or noisy channels for later removal indicates that the unflagged data does not contain such detected noise or abnormalities).
Re. Claim 6: Stein as modified by Gross and Leuthardt teaches the invention according to claim 1. Stein further teaches the invention wherein the channel detector is configured to arrange data from each of the plurality of sensors into a corresponding channel (Paragraph 0255: “Electronic circuitry 3110 couples to each of the sensors. In one embodiment, a channel is assigned to each sensor”).
Re. Claim 7: Stein as modified by Gross and Leuthardt teaches the invention according to claim 6. Leuthardt, in teaching further detail regarding the modification, further teaches the invention wherein the channel detector is configured to select channels based on a presence of the data tag with each channel (see citation of rejection of claim 1: “flagging”).
Re. Claim 8: Stein as modified by Gross and Leuthardt teaches the invention according to claim 7. Leuthardt, in teaching further detail regarding the modification, further teaches the invention wherein the channel detector is configured to automatically omit a channel including the data tag
(see citation of rejection of claim 1).
Re. Claim 9: Stein as modified by Gross and Leuthardt teaches the invention according to claim 6. Leuthardt, in teaching further detail regarding the modification, further teaches the invention wherein the channel detector is configured to automatically omit a channel including improper data
(see citation of rejection of claim 1; as best understood, the selection process is automatically performed).
Re. Claim 11: Stein as modified by Gross and Leuthardt teaches the invention according to claim 1. The processor cited in Stein includes citation to electronic circuitry 2812, which is located within the implant itself. Leuthardt, in teaching details related to the components which perform channel selection, teaches that such data processing may be carried out by a number of processors or controllers, including those of the implant, or a remote device (Paragraph 0036). Thus, the processor of Stein, in light of modification of Leuthardt, is capable of communication with an external server to carry out operations of the claimed channel detector, wherein it would be obvious to select an external source to do so to reduce processing load on the processor located within the implant of the device of Stein.
Re. Claim 12: Stein as modified by Gross and Leuthardt teaches the invention according to claim 11. Gross teaches implementation of a neural network, and further discloses processing data via a server, such as a cloud-based server, which encompasses an external source adapted to communicate with a neural network (Paragraph 0239; Fig. 5).
Re. Claim 13: Stein as modified by Gross and Leuthardt teaches the invention according to claim 1. Leuthardt teaches processing steps which encompass those of the claimed channel detector (see rejection of claim 1). Both Stein and Leuthardt state that a number of components may be used to carry out processing functions (see citations of claims 1 and 11). Thus, the combination of references teaches implementation of a channel detector within processing components of an implant while still being operatively coupled to a processor in any of the alternative citations of the rejection of claim 1.
It would have been obvious to one having skill in the art before the effective filing date to have modified Stein as modified by Gross and Leuthardt to include a processing module disposed within the joint implant capable of carrying out channel selecting processes as taught by the data processing of Leuthardt (see processor/controller(s) 14 of Leuthardt located within implant 20), the motivation being that doing so reduces the computational load on a connected computer for processing data.
Re. Claim 18: Stein as modified by Leuthardt teaches the invention according to claim 17 (see rejection headings below), including the invention further comprising an external source operatively coupled to the processor of the joint implant (see any source external to implant components in citations of claim 1), However, Stein is silent regarding such components processing joint data via a neural network.
Gross teaches the invention further comprising an external source operatively coupled to the processor of the joint implant, wherein the external source is connected to a neural network adapted to receive the data from the processor (see rejection of claim 1).
It would have been obvious to one having skill in the art before the effective filing date to have modified Stein as modified by Leuthardt to have the processor adapted to communicate with a neural network as taught by Gross, the motivation being that the neural network may process sensor data to identify implant sensor instability, degradation, a cause thereof, as well as determine a suitable physical therapy in to remediate detected instability from sensor signals (see cited portions).
Re. Claim 19: Stein as modified by Leuthardt and Gross teaches the invention of claim 18. See rejection of claim 11 regarding limitations of an external source including a channel detector.
Re. Claim 20: Stein as modified by Leuthardt and Gross teaches the invention of claim 19. Stein further teaches the invention wherein the second implant includes an antenna configured to operatively couple the processor to the external source (Paragraph 0184: “In the present invention parameters are measured with an integrated wireless sensing module or device comprising an i) encapsulating structure that supports sensors and contacting surfaces and ii) an electronic assemblage that integrates a power supply, sensing elements, an accelerometer, antennas, electronic circuitry that controls and processes a measurement sequence, and wireless communication circuitry;” Paragraph 0220: “Electronic circuitry 3110 includes transmit circuitry and an antenna for transmitting data from the sensors to a remote system;” Paragraph 0236: “A directional antenna can be placed in proximity to transmissive region 3702 to send and receive information to a remote system”).
Claims 2-4, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over:
Stein et al. (US 20140171754 A1) (disclosed by Applicant) (hereinafter – Stein) in view of
Gross et al. (US 20210369471 A1) (disclosed by Applicant) (hereinafter – Gross) in further view of
Leuthardt et al. – (US 20210361948 A1) (hereinafter – Leuthardt) in further view of
DiSilvestro et al. (US 20050010301 A1) (disclosed by Applicant) (hereinafter – DiSilvestro).
Re. Claim 2: Stein as modified by Gross and Leuthardt teaches the invention according to claim 1, but does not teach the invention wherein the plurality of sensors are Hall sensor assemblies.
DiSilvestro teaches analogous art in the technology of joint prosthetics (Abstract). DiSilvestro further teaches the invention wherein the plurality of sensors are Hall sensor assemblies (Paragraph 0059: “In this particular embodiment, the sensor 28 is a Hall effect transducer…;” see Paragraph 0077 of DiSilvestro regarding use of a plurality of sensors).
It would have been obvious to one having skill in the art before the effective filing date to have modified Stein as modified by Gross and Leuthardt to have included Hall effect sensors as taught by DiSilvestro, the motivation being that doing so enables the sensor implant to provide accurate positional readings (Paragraph 0059) which can be used to assess whether the joint space between implant components has changed over time (Paragraph 0008), which provides allows for assessment or compensation for potential migration or subsidence of bone-affixed implants (Paragraph 0077).
Re. Claim 3: Stein as modified by Gross, Leuthardt, and DiSilvestro teaches the invention according to claim 2. DiSilvestro, in teaching further detail regarding the modification, further teaches the invention wherein each of the plurality of the Hall sensor assemblies are configured to measure positioning and movement data of the joint implant (Abstract: “This system can be used to measure a dimension of the joint space and to determine whether a dimension of the joint space has changed over time;” Paragraph 0072: measurement of distance (i.e., positioning or movement relative to) between sensor and signal source).
Re. Claim 4: Stein as modified by Gross, Leuthardt, and DiSilvestro teaches the invention according to claim 3. DiSilvestro, in teaching further detail regarding the modification, further teaches the invention wherein each of the plurality of the Hall sensor assemblies are configured to measure a coordinate in an X-direction, a coordinate in a Y- direction, and a coordinate in a Z-direction (Paragraph 0060: Hall effect sensors may be three-dimensional Hall effect sensors; Paragraph 0077: “Three-dimensional sensing may also be employed to improve accuracy and to compensate for potential migration or subsidence of bone-affixed implants”).
Re. Claim 15: Stein as modified by Gross and Leuthardt teaches the invention according to claim 1, but does not teach the invention wherein the plurality of sensors are activated when brought into proximity with an external source.
DiSilvestro teaches the invention wherein the plurality of sensors are activated when brought into proximity with an external source (Paragraph 0064: “To conserve power, it may be desirable to employ an inductively activated switch to selectively draw power from the battery;” Paragraph 0063: sensors are preprogrammed to activate).
It would have been obvious to one having skill in the art before the effective filing date to have modified Stein as modified by Gross and Leuthardt to include the proximity-based activation of sensors as taught by DiSilvestro, the motivation being that doing so conserves power (Paragraph 0064).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over:
Stein et al. (US 20140171754 A1) (disclosed by Applicant) (hereinafter – Stein) in view of
Gross et al. (US 20210369471 A1) (disclosed by Applicant) (hereinafter – Gross) in further view of
Leuthardt et al. – (US 20210361948 A1) (hereinafter – Leuthardt) in further view of
Sutoko et al. (US 20170231561 A1) (Sutoko).
Re. Claim 10: Stein as modified by Gross and Leuthardt teaches the invention according to claim 9, but does not teach wherein the channel detector is configured to output all channels excluding the channel including improper data to be viewed by a user.
Sutoko teaches analogous art in the technology of sensors having multiple measurement channels (Paragraph 0057). Sutoko further teaches the invention wherein the channel detector is configured to output all channels excluding the channel including improper data to be viewed by a user (Paragraph 0083: “The details of hemoglobin waveform 600 before and after administration include display items that includes a selected channel 601 indicative of the selected channel, a selected signal display region 602 indicative of the selected biometric signal, and an activity interval (stimulus period) 603 representing an interval in which a part of the patient's response signal (biometric signal) to a given task is extracted for analysis”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Stein as modified by Gross and Leuthardt to include the display of selected channels as taught by Sutoko, the motivation being that doing so allows a medical professional or other user to view signals of interest in detail (Paragraph 0081).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over:
Stein et al. (US 20140171754 A1) (disclosed by Applicant) (hereinafter – Stein) in view of
Gross et al. (US 20210369471 A1) (disclosed by Applicant) (hereinafter – Gross) in further view of
Leuthardt et al. – (US 20210361948 A1) (hereinafter – Leuthardt) in further view of
Roche et al. (US 20060224088 A1) (hereinafter – Roche).
Re. Claim 14: Stein as modified by Gross and Leuthardt teaches the invention according to claim 1, but does not teach wherein the plurality of sensors are automatically activated according to a timed schedule.
Roche teaches analogous art in the technology of implantable sensors (Abstract). Roche further teaches the invention wherein the plurality of sensors are automatically activated according to a timed schedule (Paragraph 0062: “The sensors would also be activated at predetermined times to monitor implant cycles, abnormal motion and implant wear thresholds”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Stein as modified by Gross and Leuthardt to further automatically activate sensors as taught by Roche, the motivation being that such periodic activation reduces the amount of data required to be analyzed.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over:
Stein et al. (US 20140171754 A1) (disclosed by Applicant) (hereinafter – Stein) in view of
Gross et al. (US 20210369471 A1) (disclosed by Applicant) (hereinafter – Gross) in further view of
Leuthardt et al. – (US 20210361948 A1) (hereinafter – Leuthardt) in further view of
Osorio et al. (US 20110306845 A1) (hereinafter – Osorio).
Re. Claim 16: Stein as modified by Gross and Leuthardt teaches the invention according to claim 1, but does not teach wherein the plurality of sensors are manually activated by a user.
Osorio teaches analogous art in the technology of implanted devices (Abstract). Osorio further teaches the invention wherein the plurality of sensors are manually activated by a user (Paragraph 0188: manual activation of an implantable medical device is known from the prior art using a variety of techniques; Paragraph 0189: the implantable medical device 400 is capable of detecting manual input).
It would have been obvious to one having skill in the art before the effective filing date to have modified Stein as modified by Gross and Leuthardt to allow the plurality of sensors to be manually activated by a user, the motivation being that doing so provides, e.g., a patient who receives the implant to have a degree of control over operation of the device and data transmission therefrom (Paragraph 0188).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over:
Stein et al. (US 20140171754 A1) (disclosed by Applicant) (hereinafter – Stein) in view of
Leuthardt et al. – (US 20210361948 A1) (hereinafter – Leuthardt).
Re. Claim 17: Stein teaches a system for tracking a joint implant (Abstract: joint implant having sensors for monitoring a variety of parameters)
comprising:
a joint implant including:
a first implant for coupling to a first bone of a joint (Fig. 1: femoral prosthetic component 104; Fig. 28: one of the hip joint prosthetic components shown);
a second implant for coupling to a second bone of the joint (Fig. 1: tibial prosthetic component 106; Fig. 27; Fig. 28: the other of the hip joint prosthetic components shown; see similar structures in Figs. 29, 31, 33, 38, 40),
the second implant including:
a plurality of sensors configured to measure data (Fig. 27: load pads 2722; Fig. 28: capacitors 2814; Fig. 29: capacitors 2906; Figs. 31, 34, 37, 40: load pads 3108; Fig. 37: temperature sensor 3704, pH sensor 3706, photo-diode array 3710);
a processor operatively coupled to the plurality of sensors and adapted to arrange the data into channels (Paragraph 0255: “Electronic circuitry 3110 couples to each of the sensors. In one embodiment, a channel is assigned to each sensor”).
Stein does not teach the invention comprising a channel detector operatively coupled to the processor to detect the channels containing the data and select the channels containing the data to output to a user; wherein the channel detector is configured to exclude a first channel from selection and output a second channel to the user, wherein the first channel is excluded based on a data tag applied by the processor of the first channel identifying the data of the first channel as inaccurate data.
Leuthardt teaches a channel detector operatively coupled to the processor to detect the channels containing the data and select the channels containing the data to output to a user (Paragraph 0036; “The data is processed by the one or more processor/controllers, and/or by a processor included in the portable communication device and/or by the at least one remote processor for modulating and/or controlling the stimulating of one or more brain regions to treat the mood disorder;” Paragraph 0165: “Signals recorded from the system are processed in the following fashion. Channels with abnormal amplitude (e.g. >±1000 mV) or power spectra (e.g. harmonic noise) are flagged and removed from further analysis”);
wherein the channel detector is configured to exclude a first channel from selection and output a second channel to the user (see citation above),
wherein the first channel is excluded based on a data tag applied by the processor of the first channel identifying the data of the first channel as inaccurate data (see citation above).
It would have been obvious to one having skill in the art before the effective filing date to have modified Stein to include the data flagging and exclusion process as taught by Leuthardt, the motivation being that doing so removes noise and/or abnormalities in the final set of signals for analysis (Paragraph 0165).
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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/JUSTIN XU/ Primary Examiner, Art Unit 3791
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