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 .
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 1-9, 11-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over:
Disilvestro et al. (US 20050010301 A1) (disclosed by Applicant) (hereinafter – Disilvestro) in view of
Gross et al. (US 20210369471 A1) (disclosed by Applicant) in further view of
Zhang et al. (US 20230114833 A1) (hereinafter – Zhang).
Re. Claim 1: Disilvestro teaches a joint implant (Title; Abstract)
comprising:
a first implant for coupling to a first bone of a joint (Fig. 1: femoral component 24; see similar parts in Figs. 4, 6-8, 10, 12, and 15); and
a second implant for coupling to a second bone of the joint adjacent the first implant (Fig. 1: tibial bearing 16; see similar parts in Figs. 4, 6-8, 10, 12, and 15).
While Disilvestro does not disclose an embodiment in which the second implant comprises a plurality of sensors configured to measure data, Disilvestro teaches that a plurality of sensors may be used to provide redundancy in case of failure of one or more of the sensors, or used to provide measurement distances at different parts of the joint, whereby three-dimensional sensing may be employed to improve accuracy and to compensate for potential migration of subsidence of bone-affixed implants (Paragraph 0077). Thus, it would have been obvious to modify the single-sensor embodiments of Disilvestro to utilize a plurality of sensors for such reasons above.
Disilvestro further teaches a processor operatively coupled to the plurality of sensors and adapted to receive the data from the sensors (Figs. 2, 5, 11: external receiver 40 and data interpretation device 42, described at Paragraph 0070: “… a hand-held personal computer, a personal desk assistant, a laptop computer or any custom-designed data acquisition device”; Fig. 8: external receiver 86 and external computer 88; Paragraph 0092: “For analysis and display of RF data transmitted by the implant, hardware and software may be used such as LabView software and associated equipment available from National Instruments Corporation of Austin, Tex”).
Disilvestro 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 Disilvestro 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 mediate detected instability from sensor signals (see cited portions).
Disilvestro as modified by Gross does not teach a channel detector configured to exclude a first portion of the data received from the processor and output a second portion of the data.
Zhang teaches analogous art in the technology of analysis of multi-sensor data (Abstract). Zhang further teaches the invention comprising a channel detector configured to exclude a first portion of the data received from the processor and output a second portion of the data (Paragraphs 0100, 0128, 0130: each describing processing and components therefor which receive data from multiple sensors into channels and select channels having the highest quality, least number of outliers, noise, etc.; Examiner notes that selection of certain channels implies exclusion of other channels).
It would have been obvious to one having skill in the art before the effective filing date to have modified the plurality of plurality of sensor signals of Disilvestro as modified by Gross to be processed via multi-channel processing taught by Zhang, the motivation being that doing so produces an increased quality of resulting signals for analysis or use (see cited paragraphs).
Re. Claim 2: Disilvestro as modified by Gross and Zhang teaches the invention according to claim 1. 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 transduce…;” see modification of Disilvestro in rejection of claim 1 regarding use of a plurality of sensors).
Re. Claim 3: Disilvestro as modified by Gross and Zhang teaches the invention according to claim 2. Disilvestro 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: Disilvestro as modified by Gross and Zhang teaches the invention according to claim 3. Disilvestro 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 5: Disilvestro as modified by Gross and Zhang teaches the invention according to claim 1. Zhang further teaches the invention wherein the first portion of the data is inaccurate data and the second portion of the data is accurate data (see citation of rejection of claim 1: selection of highest quality, least outliers or noise is indicative of a portion having what may be considered inaccurate data).
Re. Claim 6: Disilvestro as modified by Gross and Zhang teaches the invention according to claim 1. Zhang further teaches the invention wherein the channel detector is configured to arrange data from each of the plurality of sensors into a corresponding channel (Zhang teaches components which process data from multiple sensors (e.g., the plurality of Hall effect sensors of the modified Disilvestro) into a plurality of channels).
Re. Claim 7: Disilvestro as modified by Gross and Zhang teaches the invention according to claim 6. Zhang further teaches the invention wherein the channel detector is configured to select channels based on a presence of a data tag with each channel (see citation of rejection of claim 1: selection of highest quality, least outliers or noise is indicative of a portion having what may be considered inaccurate data; Examiner notes that the presence of outliers, noise, or low quality may be interpretable as a “tag” since the claims do not further define this term; Examiner is interpreting “tag” as an identifying part).
Re. Claim 8: Disilvestro as modified by Gross and Zhang teaches the invention according to claim 1. Zhang further teaches the invention wherein the channel detector is configured to automatically omit a channel including the data tag (see citation of rejections of claim 7).
Re. Claim 9: Disilvestro as modified by Gross and Zhang teaches the invention according to claim 1. Zhang 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: Disilvestro as modified by Gross and Zhang teaches the invention according to claim 1. The processor cited in Disilvestro is data interpretation device 42, which encompasses a standard computer (Fig. 2; Paragraph 0070). Zhang, in teaching details related to the components which perform channel selection, teaches that such an action may be carried out by “the wearable device” (i.e., akin to the implant of Disilvestro) or “other components of the system 200,” whereby the system 200 includes a personal user device as well as communication with a server 110 (Figs. 1, 2). Thus, the processor of the data interpretation device 42, in light of modification of Zhang, 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 data interpretation device 42.
Re. Claim 12: Disilvestro as modified by Gross and Zhang 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: Disilvestro as modified by Gross and Zhang teaches the invention according to claim 1. Disilvestro does not teach a component which may function as a channel detector (including functions of omitting certain portions of data) disposed within the implant.
Zhang teaches the channel detector (see rejection of claim 1). Zhang further states that a number of components may be used to carry out the function of selecting a particular channel, including a wearable device akin to the implant (Fig. 2: see ring 104 having processing module 230-a is considered part of system 200; Paragraph 0130: particularly, “the wearable device and/or other components of the system 200 may be configured to select one motion channel from the set of channels…”). Thus, Zhang teaches implementation of a channel detector within a device akin to that of the implant of Disilvestro while still being operatively coupled to a processor.
It would have been obvious to one having skill in the art before the effective filing date to have modified Disilvestro as modified by Gross and Zhang to further include a processing module disposed within the joint implant capable of carrying out channel selecting processes as taught by Zhang, the motivation being that doing so reduces the computational load on a connected computer for processing data.
Re. Claim 15: Disilvestro as modified by Gross and Zhang teaches the invention according to claim 1. Disilvestro further 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).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over:
Disilvestro et al. (US 20050010301 A1) (disclosed by Applicant) (hereinafter – Disilvestro) in view of
Gross et al. (US 20210369471 A1) (disclosed by Applicant) in further view of
Zhang et al. (US 20230114833 A1) (hereinafter – Zhang) in further view of
Sutoko et al. (US 20170231561 A1) (Sutoko).
Re. Claim 10: Disilvestro as modified by Gross and Zhang 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 Disilvestro as modified by Gross and Zhang 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:
Disilvestro et al. (US 20050010301 A1) (disclosed by Applicant) (hereinafter – Disilvestro) in view of
Gross et al. (US 20210369471 A1) (disclosed by Applicant) in further view of
Zhang et al. (US 20230114833 A1) (hereinafter – Zhang) in further view of
Roche et al. (US 20060224088 A1) (hereinafter – Roche).
Re. Claim 14: Disilvestro as modified by Gross and Zhang 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 Disilvestro as modified by Gross and Zhang 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 until necessary, as compared to continuous data transmission in the device of Disilvestro.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over:
Disilvestro et al. (US 20050010301 A1) (disclosed by Applicant) (hereinafter – Disilvestro) in view of
Gross et al. (US 20210369471 A1) (disclosed by Applicant) in further view of
Zhang et al. (US 20230114833 A1) (hereinafter – Zhang) in further view of
Osorio et al. (US 20110306845 A1) (hereinafter – Osorio).
Re. Claim 14: Disilvestro as modified by Gross and Zhang 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 Disilvestro as modified by Gross and Zhang 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:
Disilvestro et al. (US 20050010301 A1) (disclosed by Applicant) (hereinafter – Disilvestro) in view of
Zhang et al. (US 20230114833 A1) (hereinafter – Zhang).
Re. Claim 17: Disilvestro teaches a system for tracking a joint implant comprising:
a joint implant including:
a first implant for coupling to a first bone of a joint;
a second implant for coupling to a second bone of the joint, the second implant including:
a plurality of sensors configured to measure data
(see rejection of claim 1).
Disilvestro does not teach:
a processor operatively coupled to the plurality of sensors and adapted to arrange the data into channels; and
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.
Zhang teaches each of the above limitations (see rejection of claim 1).
Thus, Disilvestro as modified by Zhang teaches the invention according to claim 17.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over:
Disilvestro et al. (US 20050010301 A1) (disclosed by Applicant) (hereinafter – Disilvestro) in view of
Zhang et al. (US 20230114833 A1) (hereinafter – Zhang) in further view of
Gross et al. (US 20210369471 A1) (disclosed by Applicant).
Re. Claim 18: Disilvestro as modified by Zhang teaches the invention according to claim 17. 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 rejections of claims 11 and 12).
Thus, Disilvestro as modified by Zhang and Gross teaches the invention of claim 18.
Re. Claim 19: Disilvestro as modified by Zhang and Gross teaches the invention of claim 19. See 8rejection of claim 11 regarding limitations of an external source including a channel detector.
Re. Claim 20: Disilvestro as modified by Zhang and Gross teaches the invention of claim 19. Disilvestro further teaches the invention wherein the second implant includes an antenna configured to operatively couple the processor to the external source (Paragraph 0065: “The modulator/transmitter 36 serves to convert the voltage (the second signal) produced by the Hall effect transducer (sensor 28) to a transmitter signal that can be transmitted from the internal antenna to a location outside of the patient's body. For example, the modulator/transmitter 36 can encode or modulate a particular voltage (second signal) onto a radio-frequency wave (transmitter signal). This particular radio-frequency wave can then be transmitted outside of the patient's body through an internal antenna (not shown);” Fig. 2).
Conclusion
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/JUSTIN XU/ Primary Examiner, Art Unit 3791