DETAILED ACTION
Claims 1-20 are 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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/08/2023 and 09/18/2023 are being considered by the examiner.
Claim Objections
Claim 16 is objected to because of the following informalities:
Regarding claim 16, lines 8-9 recite “the magnet”, however it appears it should read --the at least one magnet-- (emphasis added).
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 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (US 20210369471 A1), hereinafter referred to as Gross, in view of, Bohm et al. (US 20120078071 A1), hereinafter referred to as Bohm.
The claims are generally directed towards a joint implant comprising: a first implant coupled to a first bone of a joint, and a second implant coupled to a second bone of the joint, the second implant including: one or more sensors, a processor, a battery, and a switch, wherein the switch couples the battery to the processor to power the processor and the one or more sensors when the switch detects a magnetic field strength.
Regarding claim 1, Gross discloses a joint implant (Abstract, Fig. 1, Fig. 2, Fig. 4, para. [0018], para. [0372]) comprising:
a first implant coupled to a first bone of a joint (Fig. 39, para. [0005], “femoral component … attached to the femoral head of the knee joint … total hip arthroplasty … shoulder arthroplasty … total joint arthroplasty …”, para. [0274]), and
a second implant coupled to a second bone of the joint (Fig. 3, Fig. 4, Fig. 39, para. [0005], “tibial component, tibial insert … total hip arthroplasty … shoulder arthroplasty … total joint arthroplasty …”, para. [0274], para. [0336], “kinematic implantable device … be a component in a larger medical device, such as an artificial joint …”, para. [0372], para. [0496]), the second implant including:
one or more sensors (para. [0289], “detect, measure and/or monitor one or more different aspects of a body tissue …”, para. [0337], “includes one or more sensors to collect information and kinematic data …”),
a processor (Fig. 4, element 1032, para. [0373], para. [0384], “control circuit … microcontroller or microprocessor …”),
a battery (Fig. 4, element 1012, para. [0374], “battery …”), and
a switch (Fig. 4, element 1016, para. [0376], “switch …”).
Gross discloses the switch is configured to couple and decouple the battery from a sensor, in response to a control signal from the control circuit to transition, and collects data from the one or more sensors (para. [0376], para. [0387-0389]).
However, Gross does not explicitly disclose wherein the switch couples the battery to the processor to power the processor and the one or more sensors when the switch detects a magnetic field strength.
Bohm teaches an analogous method and system for transitioning a battery and processor from a low power mode, to a normal operational mode (Abstract, para. [0162]). Bohm teaches a switch (Fig. 5A, element 520, para. [0166]). Bohm further teaches the switch couples the battery to the processor to power the processor and one or more sensors when the switch detects a magnetic field strength (Fig. 5A, para. [0166], para. [0173-0175]). 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 switch disclosed by Liao to explicitly be a switch that detects a magnetic field strength, as taught by Bohm. One of ordinary skill in the art would recognize a magnetic field switch, such as a reed switch, is a simple substitution of a switch that senses a control signal, to cause a processor and battery to transition from a low power to high power state (para. [0162-0164]).
Regarding claim 2, modified Gross discloses the joint implant of claim 1.
However, modified Gross does not explicitly disclose wherein the first implant includes a magnet, the magnet generating the magnetic field strength detected by the switch.
Bohm further teaches a first component includes a magnet, the magnet generating the magnetic field strength detected by the switch (Fig. 5A, element 526, para. [0170-0171]). 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 first implant taught by modified Gross to additionally include a magnet, the magnet generating the magnetic field strength detected by the switch. One of ordinary skill in the art would recognize a magnetic field switch, such as a reed switch, is a simple substitution of a switch that senses a control signal and/or an IMU signal, and the magnet being placed in one implant allows for the activation of the processor in response to a magnetic field strength change/motion (para. [0170-0171]).
Regarding claim 3, modified Gross discloses the joint implant of claim 1.
However, modified Gross does not explicitly disclose wherein the magnetic field strength is generated by an external source.
Bohm further teaches the magnetic field strength is generated by an external source (para. [0176]). 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 magnetic field strength taught by modified Gross to explicitly be generated by an external source, as taught by Bohm. This is because Bohm teaches an external magnetic source allows for the low power mode or transition to be initiated by the user (para. [0176]).
Regarding claim 4, modified Gross discloses the joint implant of claim 2.
However, modified Gross does not explicitly disclose where the magnetic field strength is defined by a predetermined threshold.
Bohm further teaches the magnetic field strength is defined by a predetermined threshold (para. [0171]). 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 magnetic field strength to be defined by a predetermined threshold, as taught by Bohm. This is because Bohm teaches a predetermined threshold allows for the switch to transition to a second state (para. [0171]).
Regarding claim 5, modified Gross discloses the joint implant of claim 4.
However, modified Gross does not explicitly disclose where a distance between the first implant and the second implant is directly proportional to the magnetic field strength detected by the switch.
As to location(s) of the first implant and the second implant (and the magnet and the switch), Bohm teaches the magnet and the switch are placed at a distance such that the switch is closed at a first distance, and the switch is open at a second distance (para. [0171]). The location(s) of first implant and the second implant will depend upon the strength of the magnet and the strength of the magnet switch. As such, the location(s) of the first implant and the second implant (and the magnet and the switch) are results-effective variables that would have been optimized through routine experimentation based on the teachings of Bohm. It would have been obvious to one of ordinary skill in the art at the time of invention to select the location(s) of first implant and the second implant so as to be proportional to the magnetic field strength detected by the switch.
Regarding claim 6, modified Gross discloses the joint implant of claim 4, wherein the joint is a knee joint, the first implant is a femoral implant and the second implant is a tibial implant (Fig. 39, para. [0005], para. [0274]).
Regarding claim 7, modified Gross discloses the joint implant of claim 6, wherein the tibial implant is a tibial insert (Fig. 39, para. [0005], para. [0274]).
Regarding claim 11, modified Gross discloses the joint implant of claim 2, wherein the joint implant is any of a shoulder joint, and a hip joint (para. [0005], para. [0018], para. [0303]).
Regarding claim 12, modified Gross discloses the joint implant of claim 4.
However, modified Gross does not explicitly disclose wherein the switch is configured to decouple the battery from the processor to deactivate the processor and the one or more sensors when the detected magnetic field strength is below the predetermined threshold.
Bohm further teaches the switch is configured to decouple the battery from the processor to deactivate the processor and the one or more sensors in response to a magnetic field strength (para. [0162-0164]). 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 switch to additionally be configured to decouple the battery from the processor to deactivate the processor and the one or more sensors in response to a magnetic field, as taught by Bohm. This is because Bohm teaches a magnetic field allows for sensor electronics to transition to a low power mode to save battery (para. [0162-0164]).
Further, in response to “the detected magnetic field strength being below the predetermined threshold”, reversal of parts or the operation of the switch, such that a magnetic field strength being below the predetermined threshold (or being moved a distance away from the switch) to deactivate the processor would have been obvious to one of ordinary skill in the art (MPEP 2144.04, VI, A).
Regarding claim 13, modified Gross discloses the joint implant of claim 2, wherein the joint is a hip joint, the first implant is a hip insert and the second implant is a femoral head (para. [0005], para. [0018], para. [0296], para. [0303], para. [0877-0879]).
Regarding claim 14, modified Gross discloses the joint implant of claim 2, wherein the joint is a shoulder joint, the first implant is a glenoid sphere and the second implant is a shoulder insert (para. [0005], para. [0018], para. [0303], para. [0877-0879]).
Regarding claim 15, modified Gross discloses the joint implant of claim 1.
However, modified Gross does not explicitly disclose wherein the switch includes a magnetic sensor to detect the magnetic field strength.
Bohm further teaches the switch includes a magnetic sensor to detect the magnetic field strength (Fig. 5A, element 520, para. [0166]). 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 switch taught by modified Gross to explicitly be a magnetic sensor to detect the magnetic field strength, as taught by Bohm. One of ordinary skill in the art would recognize a magnetic field switch, such as a reed switch, is a simple substitution of a switch that senses a control signal and/or an IMU signal, to cause a processor and battery to transition from a low power to high power state (para. [0162-0164]).
Regarding claim 16, Gross discloses a method of activating a processor of a joint implant (Abstract, Fig. 1, Fig. 2, Fig. 4, para. [0018]), the method comprising the steps of:
coupling a first implant to a first bone of a joint (Fig. 39, para. [0005], “femoral component … attached to the femoral head of the knee joint … total hip arthroplasty … shoulder arthroplasty … total joint arthroplasty …”, para. [0274]), and
placing a second implant adjacent the first implant to activate a switch in the second implant to couple a battery of the second implant to a processor of the second implant to power the processor and one or more sensors of the second implant (Fig. 3, Fig. 4, Fig. 39, para. [0005], “tibial component, tibial insert … total hip arthroplasty … shoulder arthroplasty … total joint arthroplasty …”, para. [0274], para. [0336], “kinematic implantable device … be a component in a larger medical device, such as an artificial joint …”, para. [0372-0376], para. [0387-0389], para. [0496]).
Gross discloses the switch is configured to couple and decouple the battery from a sensor, in response to a control signal from the control circuit to transition, and collects data from the one or more sensors (para. [0376], para. [0387-0389]).
However, Gross does not explicitly disclose the first implant includes at least one magnet, wherein the switch is activated by detecting a magnetic field strength generated by the magnet.
Bohm teaches an analogous method and system for transitioning a battery and processor from a low power mode, to a normal operational mode (Abstract, para. [0162]). Bohm teaches a switch (Fig. 5A, element 520, para. [0166]) and a magnet (Fig. 5A, element 526). Bohm further teaches the switch is activated by detecting a magnetic field strength generated by the magnet (Fig. 5A, para. [0166], para. [0173-0175]). 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 disclosed by Liao to explicitly be a switch and a magnet that detects a magnetic field strength, as taught by Bohm. One of ordinary skill in the art would recognize a magnetic field switch, such as a reed switch, is a simple substitution of a switch that senses a control signal and/or an IMU signal, to cause a processor and battery to transition from a low power to high power state (para. [0162-0164]).
Regarding claim 17, modified Gross discloses the method of claim 16.
However, modified Gross does not explicitly disclose where the magnetic field strength is defined by a predetermined threshold.
Bohm further teaches the magnetic field strength is defined by a predetermined threshold (para. [0171]). 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 magnetic field strength to be defined by a predetermined threshold, as taught by Bohm. This is because Bohm teaches a predetermined threshold allows for the switch to transition to a second state (para. [0171]).
Regarding claim 18, modified Gross discloses the method of claim 17.
However, modified Gross does not explicitly disclose where a distance between the first implant and the second implant is directly proportional to the magnetic field strength detected by the switch.
As to location(s) of the first implant and the second implant (and the magnet and the switch), Bohm teaches the magnet and the switch are placed at a distance such that the switch is closed at a first distance, and the switch is open at a second distance (para. [0171]). The location(s) of first implant and the second implant will depend upon the strength of the magnet, and the strength of the magnet switch. As such, the location(s) of the first implant and the second implant (and the magnet and the switch) are results-effective variables that would have been optimized through routine experimentation based on the teachings of Bohm. It would have been obvious to one of ordinary skill in the art at the time of invention to select the location(s) of first implant and the second implant so as to be proportional to the magnetic field strength detected by the switch.
Regarding claim 19, modified Gross discloses the method of claim 16, wherein the joint is a knee joint, the first implant is a femoral implant and the second implant is a tibial implant (Fig. 39, para. [0005], para. [0274]).
Regarding claim 20, modified Gross discloses the method of claim 19, wherein the tibial implant is a tibial insert (Fig. 39, para. [0005], para. [0274]).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (US 20210369471 A1), hereinafter referred to as Gross, in view of, Bohm et al. (US 20120078071 A1), hereinafter referred to as Bohm as applied to claim 6 above, and further in view of Hong Wang (US 20180177616 A1), hereinafter referred to as Wang.
Regarding claim 8, modified Gross discloses the joint implant of claim 6.
However, modified Gross does not explicitly disclose wherein the one or more sensors include at least one marker reader to detect a position of the magnet to identify positional data of the first implant with respect to the second implant.
Wang teaches an analogous joint implant (Abstract, Fig. 1, para. [0002]). Wang further teaches one or more sensors, including at least one marker reader to detect a position of a magnet to identify positional data of a first implant with respect to a second implant (Fig. 1, Fig. 2, para. [0029-0030], para. [0043], para. [0046-0049]). 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 one or more sensors taught by modified Gross to additionally include at least one marker reader to detect a position of the magnet to identify positional data of the first implant with respect to the second implant, as taught by Wang. This is because Wang teaches detecting positional data through a magnet allows for displacement to be monitored caused by movement of the articulation (para. [0027-0028]).
Regarding claim 9, modified Gross discloses the joint implant of claim 8.
However, modified Gross does not explicitly disclose wherein the marker reader is a Hall sensor.
Wang further teaches the marker reader is a Hall sensor (Fig. 1, para. [0044], para. [0046]). 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 marker reader to explicitly be a Hall sensor, as taught by Wang. This is because Wang teaches a Hall sensor is a known and predictable device for determining displacement (para. [0044], para. [0046]).
Regarding claim 10, modified Gross discloses the joint implant of claim 8, wherein the one or more sensors includes any of a load sensor, pH sensor, a temperature sensor and a pressure sensor operatively coupled to the processor (para. [0289], para. [0314], para. [0324]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Liao et al. (US 20050012610 A1) - discloses a joint implant wherein a switch couples the battery to the processor to power the processor and the one or more sensors when the switch detects an electromagnetic wand (para. [0031]).
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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