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 response filed on September 02, 2025 was considered by the examiner. Claims 2-22 are pending in the application.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 2-4, 6-8, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ehrensberger et al. (US Patent Application Publication 2017/0000918 – cited by applicant), hereinafter Ehrensberger, in view of Dacey JR. et al. (US Patent Application Publication 2010/0234793 – cited in prior action), hereinafter Dacey, and in view of Deutsch et al. (WIPO Publication WO 2020/035852 – cited in prior action), hereinafter Deutsch.
Regarding Claim 2, Ehrensberger teaches a device/method for preventing the growth of microbes on the surface of an object (see abstract; Fig. 1). Ehrensberger teaches a method for treating infection at an implantation site of at least one conductive orthopedic percutaneous implant (see abstract and ¶[0036] and ¶[0040]-[0042]; Fig. 1), comprising:
forming an electrical circuit at the at least one conductive orthopedic percutaneous implant passing through skin and fixated to at least one bone within a body (¶[0036] and ¶[0040]-[0042] the circuit formed of the potentiostatic device 11, the counter electrode 13, the reference electrode 12, and the working electrode as the object 15, ¶[0029]-[0030] the object may be an implant part of a hip replacement or a fixator pin, ¶[0044] the implant may be mounted to bone, which are orthopedic implants; Fig. 1),
the electrical circuit including a power source (¶[0036] and ¶[0040]-[0042] the potentiostatic device 11, ¶[0046]-[0047] the power source; Fig. 1),
the at least one conductive percutaneous implant (¶[0036] and ¶[0040]-[0042] the working electrode as the object 15, ¶[0029]-[0030] the object may be an implant part of a hip replacement or a fixator pin; Fig. 1),
and tissue surrounding the at least one conductive percutaneous implant (¶[0040] the tissue is a nonmetallic part of the circuit);
varying electrical power within the electrical circuit (¶[0031] and ¶[0052] the passing of current through the electrodes; Fig. 2).
Ehrensberger contemplates the detection/monitoring of infections (see ¶[0046]-[0047] and ¶[0055]), but does not specifically teach monitoring at least one electrical parameter in the electrical circuit continuously or intermittently over a period of time; determining the infection is present when a change in the at least one electrical parameter is detected; and that varying electrical power within the electrical circuit if infection is determined to be present.
Dacey teaches devices/methods for monitoring, treating, and preventing infections relating to shunt, which is a percutaneous implant (see abstract and ¶[0013]-[0014]; Fig. 1). Dacey teaches monitoring for a physiological characteristic, such as impedance (see ¶[0182]), that may be used to assess the presence of infection or a disease state, implemented via a comparison of the recorded physiological characteristic to a database of stored reference values (see ¶[0158]-[0159] and ¶[0181]- [0184]), and in response to a determination of infection, the device/method may emit electrical energy to the tissue about the implant (see ¶[0034], ¶[0133], ¶[0158]-[0164]), in which the energy emitters may be electrodes (see ¶[0109] and ¶[0143]-[0144]). In which the monitoring may include determining a rate of change determination (see ¶[0173]), which may be a real-time change in one or more parameters (see ¶[0179] and ¶[0217]).
Here, Dacey teaches to monitor the subject for infection (see above, see also ¶[0084]-[0085] and ¶[0103]), in which values may be detected from sensors, such as impedance (see ¶[0182]). Therefore, Dacey teaches monitoring at least one electrical parameter in the electrical circuit continuously or intermittently over a period of time. In this case, Dacey teaches to determine changes of one or more parameters in real-time (see ¶[0173], ¶[0179], and ¶[0217]), and that in order to perform change determinations measurements are certainly occurring over time, these can include intermittent sampling which is well-known in the art, or continuous measurements which would be expected and reasonably reads on such “real-time” determinations. In either case, one of skill in the art before the effective filing date of the claimed invention would have recognized that such teaching of Dacey can occur by continuous or intermittent measurements of parameters.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed inventio to utilize the infection monitoring/detecting and responsive stimulation logic of Dacey with the method of Ehrensberger because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) monitoring for the infection and applying the stimulus when the infection is detected would help to conserve energy by not applying the stimulus continuously when no infection detected, and provide a faster response to provide the stimulus once the infection is detected, rather than waiting for a medical professional to initiate the stimulus.
The modified Ehrensberger does not specifically teach whether the power source is wearable or not.
Deutsch teaches a system, device, and method and devices for transcutaneous nerve stimulation via electrodes and a battery operated wearable device (see abstract and pg. 80 ln. 13 – pg. 84 ln. 5; Figs. 3-4), in which the device may be implemented as a wearable device that may be worn on various locations through the body, such as via straps, belts, and other attachments (see pg. 37 ln. 18 – pg. 40 ln. 20; Figs. 3-4).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the wearable device configuration and attachment of Deutsch with the control unit and power source of the modified Ehrensberger because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) the wearable device modality of Deutsch would keep the control unit and power supply close to the patient, and provide ease of patient care/movement, as opposed to the control unit and power supply situated off of the person, such as on a wheeled tray/table.
Regarding Claim 3, Ehrensberger in view of Dacey and Deutsch teaches the method of claim 2 as stated above. Ehrensberger further teaches the at least one conductive orthopedic percutaneous implant is a percutaneous osseointegrated prosthesis implant (¶[0044]-[0045] and ¶[0061] the implant may be osseointegrated into bones).
Regarding Claim 4, Ehrensberger in view of Dacey and Deutsch teaches the method of claim 2 as stated above. Ehrensberger further teaches the at least one conductive orthopedic percutaneous implant is a pin (¶[0029], ¶[0044]-[0045], ¶[0048], and ¶[0061] the implant may be a pin).
Regarding Claim 6, Ehrensberger teaches a device/method for preventing the growth of microbes on the surface of an object (see abstract; Fig. 1). Ehrensberger teaches a method for treating infection at an implantation site of at least one conductive orthopedic percutaneous implant (see abstract and ¶[0036] and ¶[0040]-[0042]; Fig. 1), comprising the steps of:
securing a device to a patient having the at least one conductive orthopedic percutaneous implant passing through a tissue of the patient and fixated to at least one bone within the patient (¶[0029]-[0030] the object may be an implant part of a hip replacement or a fixator pin, ¶[0044] the implant may be mounted to bone, ¶[0033] and ¶[0048] the potentiostatic (computer) device 11 that may be attached to the implant externally; Fig. 1),
the device comprising:
a power source (¶[0046]-[0047] the voltage (power) source may be a battery);
at least one data processing system having one or more processors (¶[0033] and ¶[0048] the potentiostatic device 11 may be computer controlled, a computer would have one or more processors);
to supply electrical power to the at least one conductive percutaneous implant (¶[0031] and ¶[0052] the passing of current through the electrodes; Fig. 2) and
form a circuit that includes the at least one conductive percutaneous implant (¶[0036] and ¶[0040]-[0042] the circuit formed of the potentiostatic device 11, the counter electrode 13, the reference electrode 12, and the working electrode as the object 15, ¶[0029]-[0030] the object may be an implant part of a hip replacement or a fixator pin, ¶[0044] the implant may be mounted to bone; Fig. 1) and
tissue surrounding the at least one conductive percutaneous implant (¶[0040] the tissue is a nonmetallic part of the circuit);
increase the electrical power within the electrical circuit (¶[0031] and ¶[0052] the passing of current through the electrodes; Fig. 2).
Ehrensberger contemplates the detection/monitoring of infections (see ¶[0046]-[0047] and ¶[0055]), but does not specifically teach that the device comprises a housing, an electrical sensor; activating the power source; wherein the electrical sensor generates a signal indicative of at least one electrical parameter of the circuit; monitoring the signal indicative of the at least one electrical parameter continuously or intermittently over a period of time, wherein the one or more processors of the at least one data processing system receive the signal and analyze the signal; detecting at least one of a presence or change of infection of the tissue based on a change in the at least one electrical parameter; and passing a control signal to the power source of the device to increase the electrical power and thereby treat infection of the tissue if the change in the at least one electrical parameter is detected.
Dacey teaches devices/methods for monitoring, treating, and preventing infections relating to shunt, which is a percutaneous implant (see abstract and ¶[0013]-[0014]; Fig. 1). Dacey teaches monitoring for a physiological characteristic, such as impedance (see ¶[0182]) or resistance (see ¶[0190]-[0191] the resistance measured via the resistance sensor), that may be used to assess the presence of infection or a disease state, implemented via a comparison of the recorded physiological characteristic to a database of stored reference values (see ¶[0158]-[0159] and ¶[0181]- [0184]), and in response to a determination of infection, the device/method may emit electrical energy to the tissue about the implant (see ¶[0034], ¶[0133], ¶[0158]-[0164]), in which the energy emitters may be electrodes (see ¶[0109] and ¶[0143]-[0144]). Dacey teaches that a data processing system that may control the components of the system may be utilized, which may include a housing (see ¶[0397]). Darcey also teaches that a controller, such as a processor or microprocessor, that is operatively coupled to and configured to control the energy emitters, which may be implemented via energy ON and OFF (see ¶[0151]-[0153]). Dacey teaches that the physiological characteristic may be detected via one or more sensors connected to the controller (see ¶[0015], ¶[0018]-[0019], ¶[0178]-[0179], and ¶[0190]-[0191]). In which the monitoring may include determining a rate of change determination (see ¶[0173]), which may be a real-time change in one or more parameters (see ¶[0179] and ¶[0217]).
Here, Dacey teaches to monitor the subject for infection (see above, see also ¶[0084]-[0085] and ¶[0103]), in which values may be detected from sensors, such as impedance (see ¶[0182]). Therefore, Dacey teaches monitoring at least one electrical parameter in the electrical circuit continuously or intermittently over a period of time. In this case, Dacey teaches to determine changes of one or more parameters in real-time (see ¶[0173], ¶[0179], and ¶[0217]), and that in order to perform change determinations measurements are certainly occurring over time, these can include intermittent sampling which is well-known in the art, or continuous measurements which would be expected and reasonably reads on such “real-time” determinations. In either case, one of skill in the art before the effective filing date of the claimed invention would have recognized that such teaching of Dacey can occur by continuous or intermittent measurements of parameters.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed inventio to utilize the infection monitoring/detecting via the one or more sensors and responsive stimulation logic of Dacey with the method of Ehrensberger because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) monitoring for the infection and applying the stimulus when the infection is detected would help to conserve energy by not applying the stimulus continuously when no infection detected, and provide a faster response to provide the stimulus once the infection is detected, rather than waiting for a medical professional to initiate the stimulus.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the controller and operable signal of Darcey with the modified Ehrensberger because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) the modified Ehrensberger teaches to apply power to an implant site and Darcey teaches one such suitable method of controlling the ON/OFF application of the power.
In addition, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the housing of Darcey with the modified Ehrensberger because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) the housing would provide protection from the environment for the electronics (i.e., the controller) present in the device.
The modified Ehrensberger teaches that the implant monitor is wearable, as it is worn on the implant, as well as the control unit and power supply, which may be embedded with the implant (see Ehrensberger ¶[0046]-[0047]), but does not specifically teach whether the device (i.e., the electronics) is wearable or not.
Deutsch teaches a system, device, and method and devices for transcutaneous nerve stimulation via electrodes and a battery operated wearable device (see abstract and pg. 80 ln. 13 – pg. 84 ln. 5; Figs. 3-4), as well as the usage of various sensors (see pg. 66 ln. 22 – pg. 68 ln. 12), in which the device may be implemented as a wearable device that may be worn on various locations through the body, such as via straps, belts, and other attachments (see pg. 37 ln. 18 – pg. 40 ln. 20; Figs. 3-4).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the wearable device configuration and attachment of Deutsch with the control unit and power source of the modified Ehrensberger because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) the wearable device modality of Deutsch would keep the control unit and power supply close to the patient, and provide ease of patient care/movement, as opposed to the control unit and power supply situated off of the person, such as on a wheeled tray/table.
Regarding Claim 7, Ehrensberger in view of Dacey and Deutsch teaches the method of claim 6 as stated above. The modified Ehrensberger further teaches the electrical sensor of the device monitors resistance within the circuit (see Dacey ¶[0190]-[0191] the resistance measured via the resistance sensor).
Regarding Claim 8, Ehrensberger in view of Dacey and Deutsch teaches the method of claim 6 as stated above. Ehrensberger further teaches the power source of the device includes a reference electrode that is placed upon a skin of the patient (¶[0044] the reference electrode 87 placed on the skin 88 of the patient; Fig. 8).
Regarding Claim 11, Ehrensberger in view of Dacey and Deutsch teaches the method of claim 6 as stated above. Ehrensberger further teaches a wireless communication device (¶[0046]-[0047] the wireless telemetry units that will enable the real-time control and monitoring of the implant electrochemical properties and stimulation parameters).
The modified Ehrensberger is silent regarding the one or more processors provide an alert to the wireless communication device and enable the wireless communication device to transmit the alert based upon the control signal.
Dacey further teaches that the response to the infection determination may include an audio/visual representation, such as an alarm (see ¶[0158]-[0164]), which may involve the communication via a wireless communication (see ¶[0154], ¶[0176], ¶[0185], ¶[0301], ¶[0327], and ¶[0398]-[0400]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the alarm based upon the control signal logic of Darcey with the wireless telemetry of the modified Ehrensberger because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results; and/or (2) outputting an alert (alarm) based upon the control signal would help the medical professional caring for the patient become aware of the patient’s current condition; and/or (3) utilizing a wireless communication helps to ensure that the medical professional would receive the notification without needing to be in close proximity if wires were being used.
Regarding Claim 12, Ehrensberger in view of Dacey and Deutsch teaches the method of claim 6 as stated above. The modified Ehrensberger further teaches analyzing the signal includes supplying the signal to an artificial intelligence network trained with a percutaneous implant data model to determine the at least one of the presence or change of infection of the tissue; or analyzing the signal includes comparing the signal to a stored infection parameter to determine the at least one of the presence or change of infection of the tissue (see Dacey ¶[0158]-[0159] and ¶[0181]- [0184] the assessment of the presence of infection or a disease state, implemented via a comparison of the recorded physiological characteristic to a database of stored reference values).
Claims 5, 13-15, and 18-20 rejected under 35 U.S.C. 103 as being unpatentable over Ehrensberger in view of Dacey and Deutsch as applied to claim 2 above, and in view of Pringle et al. (US Patent Application Publication 2018/0103935 – cited in prior action), hereinafter Pringle.
Regarding Claim 5, Ehrensberger in view of Dacey and Deutsch teaches the method of claim 2 as stated above. The modified Ehrensberger is silent regarding outputting a control signal reducing the electrical power supplied to the at least one conductive percutaneous implant.
Darcey further teaches that a controller, such as a processor or microprocessor, that is operatively coupled to and configured to control the energy emitters, which may be implemented via energy ON and OFF (see ¶[0151]-[0153]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the controller and operable signal of Darcey with the modified Ehrensberger because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) the modified Ehrensberger teaches to apply power to an implant site and Darcey teaches one such suitable method of controlling the ON/OFF application of the power.
The modified Ehrensberger is silent regarding that the output control signal is responsive to when the infection is not detected.
Pringle teaches methods involving tissue analysis via mass spectrometry (see abstract), including the diagnosis/monitoring of the progression of infection (¶[0472]), in which during the monitoring of the progression of the infection, the method may increase a treatment if biomarkers indicative of disease have increased or not decreased, or ceasing the treatment if the biomarkers indicative of disease have not increased or decreased in response to the treatment (see ¶[0507]-[0509]).
Accordingly, it would have been obvious to either increase or cease the treatment applied in the modified Ehrensberger as taught in Pringle because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) ceasing the treatment (reducing the electrical power) once the infection is no longer detected would prevent the patient from receiving unnecessary treatments, and would also conserve power.
Regarding Claim 13, Ehrensberger teaches a device/method for preventing the growth of microbes on the surface of an object (see abstract; Fig. 1). Ehrensberger teaches a method for treating infection at an implantation site of at least one conductive orthopedic percutaneous implant (see abstract and ¶[0036] and ¶[0040]-[0042]; Fig. 1), comprising the steps of:
securing a device to a patient having at least one conductive orthopedic percutaneous implant passing through a tissue of the patient and fixated to at least one bone within the patient (¶[0029]-[0030] the object may be an implant part of a hip replacement or a fixator pin, ¶[0044] the implant may be mounted to bone, ¶[0033] and ¶[0048] the potentiostatic (computer) device 11 that may be attached to the implant externally; Fig. 1),
the device comprising:
a power source (¶[0046]-[0047] the voltage (power) source may be a battery);
at least one data processing system having one or more processors (¶[0033] and ¶[0048] the potentiostatic device 11 may be computer controlled, a computer would have one or more processors);
to supply electrical power to the at least one conductive percutaneous implant (¶[0031] and ¶[0052] the passing of current through the electrodes; Fig. 2) and
form a circuit that includes the at least one conductive percutaneous implant (¶[0036] and ¶[0040]-[0042] the circuit formed of the potentiostatic device 11, the counter electrode 13, the reference electrode 12, and the working electrode as the object 15, ¶[0029]-[0030] the object may be an implant part of a hip replacement or a fixator pin, ¶[0044] the implant may be mounted to bone; Fig. 1) and
tissue surrounding the at least one conductive percutaneous implant (¶[0040] the tissue is a nonmetallic part of the circuit);
varying electrical power within the electrical circuit (¶[0031] and ¶[0052] the passing of current through the electrodes; Fig. 2).
Ehrensberger contemplates the detection/monitoring of infections (see ¶[0046]-[0047] and ¶[0055]), but does not specifically teach that the device comprises a housing, an electrical sensor; activating the power source; wherein the electrical sensor generates a signal indicative of at least one electrical parameter of the circuit; monitoring the signal indicative of the at least one electrical parameter continuously or intermittently over a period of time, wherein the one or more processors of the at least one data processing system receive the signal and analyze the signal; determining an infection status of the tissue, wherein the infection status is determined to be infected, not infected, or a changed amount of infection as compared to a prior infection state baseline; and passing a control signal to the power source to vary the electrical power if the infection status of the tissue is determined to be infected.
Dacey teaches devices/methods for monitoring, treating, and preventing infections relating to shunt, which is a percutaneous implant (see abstract and ¶[0013]-[0014]; Fig. 1). Dacey teaches monitoring for a physiological characteristic, such as impedance (see ¶[0182]) or resistance (see ¶[0190]-[0191] the resistance measured via the resistance sensor), that may be used to assess the presence of infection or a disease state, implemented via a comparison of the recorded physiological characteristic to a database of stored reference values (see ¶[0158]-[0159] and ¶[0181]- [0184], the determination of infection would correspond to infected or not), and in response to a determination of infection, the device/method may emit electrical energy to the tissue about the implant (see ¶[0034], ¶[0133], ¶[0158]-[0164]), in which the energy emitters may be electrodes (see ¶[0109] and ¶[0143]-[0144]). Dacey teaches that a data processing system that may control the components of the system may be utilized, which may include a housing (see ¶[0397]). Darcey also teaches that a controller, such as a processor or microprocessor, that is operatively coupled to and configured to control the energy emitters, which may be implemented via energy ON and OFF (see ¶[0151]-[0153]). Dacey teaches that the physiological characteristic may be detected via one or more sensors connected to the controller (see ¶[0015], ¶[0018]-[0019], ¶[0178]-[0179], ¶[0190]-[0191]). In which the monitoring may include determining a rate of change determination (see ¶[0173]), which may be a real-time change in one or more parameters (see ¶[0179] and ¶[0217]).
Here, Dacey teaches to monitor the subject for infection (see above, see also ¶[0084]-[0085] and ¶[0103]), in which values may be detected from sensors, such as impedance (see ¶[0182]). Therefore, Dacey teaches monitoring at least one electrical parameter in the electrical circuit continuously or intermittently over a period of time. In this case, Dacey teaches to determine changes of one or more parameters in real-time (see ¶[0173], ¶[0179], and ¶[0217]), and that in order to perform change determinations measurements are certainly occurring over time, these can include intermittent sampling which is well-known in the art, or continuous measurements which would be expected and reasonably reads on such “real-time” determinations. In either case, one of skill in the art before the effective filing date of the claimed invention would have recognized that such teaching of Dacey can occur by continuous or intermittent measurements of parameters.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed inventio to utilize the infection monitoring/detecting via the one or more sensors and responsive stimulation logic of Dacey with the method of Ehrensberger because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) monitoring for the infection and applying the stimulus when the infection is detected would help to conserve energy by not applying the stimulus continuously when no infection detected, and provide a faster response to provide the stimulus once the infection is detected, rather than waiting for a medical professional to initiate the stimulus.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the controller and operable signal of Darcey with the modified Ehrensberger because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) the modified Ehrensberger teaches to apply power to an implant site and Darcey teaches one such suitable method of controlling the ON/OFF application of the power.
In addition, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the housing of Darcey with the modified Ehrensberger because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) the housing would provide protection from the environment for the electronics (i.e., the controller) present in the device.
The modified Ehrensberger teaches whether that the infection status is determined to be a changed amount of infection as compared to a prior infection state baseline (see Darcey ¶[0158]-[0159] and ¶[0181]- [0184]). In this case, the baseline of Dacey would be considered to be the prior infection state (i.e., no infection), and the result indicating the infection would be the changed amount of infection (the baseline of no infection changing to the amount indicative of infection).
Alternatively and/or additionally, Pringle teaches methods involving tissue analysis via mass spectrometry (see abstract), including the diagnosis/monitoring of the progression of infection (¶[0472]), in which during the monitoring of the progression of the infection, the method may increase a treatment if biomarkers indicative of disease have increased or not decreased, or ceasing the treatment if the biomarkers indicative of disease have not increased or decreased in response to the treatment (see ¶[0507]-[0509]). Here, the monitoring of the progression of the infection (amount increased/decreased) would correspond to the changed amount.
Accordingly, it would have been obvious to monitor the progression of and treat the infection in the modified Ehrensberger as taught in Pringle because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) monitoring the progression of the infection and giving appropriate treatment based upon the patient’s response to the treatment/infection would improve the patient’s outcome.
The modified Ehrensberger teaches that the implant monitor is wearable, as it is worn on the implant, as well as the control unit and power supply, which may be embedded with the implant (see Ehrensberger ¶[0046]-[0047]), but does not specifically teach whether the device (i.e., the electronics) is wearable or not.
Deutsch teaches a system, device, and method and devices for transcutaneous nerve stimulation via electrodes and a battery operated wearable device (see abstract and pg. 80 ln. 13 – pg. 84 ln. 5; Figs. 3-4), as well as the usage of various sensors (see pg. 66 ln. 22 – pg. 68 ln. 12), in which the device may be implemented as a wearable device that may be worn on various locations through the body, such as via straps, belts, and other attachments (see pg. 37 ln. 18 – pg. 40 ln. 20; Figs. 3-4).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the wearable device configuration and attachment of Deutsch with the control unit and power source of the modified Ehrensberger because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) the wearable device modality of Deutsch would keep the control unit and power supply close to the patient, and provide ease of patient care/movement, as opposed to the control unit and power supply situated off of the person, such as on a wheeled tray/table.
Regarding Claim 14, Ehrensberger in view of Dacey, Pringle, and Deutsch teaches the method of claim 13 as stated above. The modified Ehrensberger further teaches the electrical sensor of the device monitors resistance within the circuit (see Dacey ¶[0190]-[0191] the resistance measured via the resistance sensor).
Regarding Claim 15, Ehrensberger in view of Dacey, Pringle, and Deutsch teaches the method of claim 13 as stated above. Ehrensberger further teaches the power source includes a reference electrode that is placed upon a skin of the patient (¶[0044] the reference electrode 87 placed on the skin 88 of the patient; Fig. 8).
Regarding Claim 18, Ehrensberger in view of Dacey, Pringle, and Deutsch teaches the method of claim 13 as stated above. Ehrensberger further teaches a wireless communication device (¶[0046]-[0047] the wireless telemetry units that will enable the real-time control and monitoring of the implant electrochemical properties and stimulation parameters).
The modified Ehrensberger is silent regarding the one or more processors provide an alert to the wireless communication device and enable the wireless communication device to transmit the alert responsive to the infection status of the tissue determined to be infected.
Dacey further teaches that the response to the infection determination may include an audio/visual representation, such as an alarm (see ¶[0158]-[0164]), which may involve the communication via a wireless communication (see ¶[0154], ¶[0176], ¶[0185], ¶[0301], ¶[0327], and ¶[0398]-[0400]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the alarm based upon the infection status logic of Darcey with the wireless telemetry of the modified Ehrensberger because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results; and/or (2) outputting an alert (alarm) based upon the infection status would help the medical professional caring for the patient become aware of the patient’s current condition; and/or (3) utilizing a wireless communication helps to ensure that the medical professional would receive the notification without needing to be in close proximity if wires were being used.
Regarding Claim 19, Ehrensberger in view of Dacey, Pringle, and Deutsch teaches the method of claim 13 as stated above. The modified Ehrensberger further teaches analyzing the signal includes supplying the signal to an artificial intelligence network trained with a percutaneous implant data model to determine the infection status of the tissue; or analyzing the signal includes comparing the signal to a stored infection parameter to determine the infection status of the tissue (see Dacey ¶[0158]-[0159] and ¶[0181]- [0184] the assessment of the presence of infection or a disease state, implemented via a comparison of the recorded physiological characteristic to a database of stored reference values).
Regarding Claim 20, Ehrensberger in view of Dacey, Pringle, and Deutsch teaches the method of claim 13 as stated above. The modified Ehrensberger further teaches varying the electrical power includes increasing an amount of the electrical power in response to the determination of the infected status of the tissue (see Dacey ¶[0034], ¶[0133], ¶[0158]-[0164] in response to a determination of infection, the device/method may emit electrical energy to the tissue about the implant; see Pringle ¶[0507]-[0509] in the monitoring of the progression of the infection, the method may increase a treatment (applied current) if biomarkers indicative of disease have increased or not decreased).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ehrensberger in view of Dacey and Deutsch as applied to claim 6 above, and in view of Arnout J. van der Borden et al. (“Prevention of pin tract infection in external stainless steel fixator frames using electric current in a goat model”, Biomaterials, 28, 2122-2126, published January 4, 2007 – cited by applicant), hereinafter van der Borden.
Regarding Claim 9, Ehrensberger in view of Dacey and Deutsch teaches the method of claim 6 as stated above. Ehrensberger further teaches the power source of the device is connected to an implant connector that is connected to the at least one conductive percutaneous implant (¶[0036] the electrical lead 14, or ¶[0045] the sterile wire or needle to contact the implant; Figs. 1 and 8-9).
The modified Ehrensberger teaches that the implant may comprise a pin (see Ehrensberger ¶[0029] and ¶[0044]) but does not specifically teach that the implant connector has a body, a first electrode, and a second electrode, the body supporting the first electrode and the second electrode, the first electrode engaging the at least one conductive percutaneous implant, and the second electrode engaging the skin of the patient, and wherein the first electrode is electrically isolated from the second electrode.
Van der Borden teaches a device/method utilized on a goat model for treating implant infections; however, it is evident throughout the paper that the method is being tested and intended for a human model (pg. 2122 §1 ¶1 reconstructive bone surgery, pg. 2123 §1 ¶3 current is safe for human application). Van der Borden teaches a power source that is connected to an implant connector (see pg. 2123 §2.2, the polycarbonate canister; Fig. 1C) that is sized and dimensioned to be connected to a conductive percutaneous implant (see Fig. 1C); in which the implant connector has a body (see pg. 2123 §2.2, the body of the polycarbonate canister; Fig. 1C), a first electrode (see pg. 2123 §2.2, the cathode; Fig. 1C), and a second electrode (see pg. 2123 §2.2, the anode; Fig. 1C); the body supporting the first electrode and the second electrode (see Fig. 1C), the first electrode positioned to engage the first conductive percutaneous implant (see Fig. 1C, the pin cathode) and the second electrode positioned to engage a skin of the patient (see Fig. 1C, the ring anode that engages the skin). Here, van der Borden does not explicitly teach “the first electrode being electrically isolated from the second electrode”; however, this is inherent to the circuit because the electrodes would need to be electrically isolated from one another or the circuit would short.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the electrode integrated implant connector of van der Borden with the implant pin embodiment of the modified Ehrensberger because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) the usage of such an implant connector would obviate the need for the medical professional caring for the patient to manually setup and connect the electrodes to the implant and patient.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ehrensberger in view of Dacey and Deutsch as applied to claim 6 above, and in view of Shor et al. (US Patent Application Publication 2022/0117511 – cited by applicant), hereinafter Shor.
Regarding Claim 10, Ehrensberger in view of Dacey and Deutsch teaches the method of claim 6 as stated above. Ehrensberger further teaches the power source of the device includes a reference electrode within the circuit (¶[0031]-[0044] the reference electrode), the reference electrode having an implant connector (¶[0036] the electrical lead 14, or ¶[0045] the sterile wire or needle to contact the implant; Figs. 1 and 8-9).
The modified Ehrensberger is silent regarding that the reference electrode is connected to a second conductive orthopedic percutaneous implant.
Shor teaches a system and method for monitoring a patient site of interest, such as a surgical implant, for infections (see abstract and ¶[0083]; Fig. 1), in which a monitoring electrode and a reference electrode may be utilized (see ¶[0048]-[0052]), and that the reference electrode may be deployed at a different site of interest and/or implantable (see ¶[0052]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the reference electrode location at a second implant of Shor with the power source and reference electrode of the modified Ehrensberger because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) including the reference electrode at a different site would allow the output of the reference electrode be used as reference to the output of the working electrode (see Shor ¶[0052]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ehrensberger in view of Dacey and Deutsch as applied to claim 11 above, and in view of Katra et al. (US Patent Application Publication 2020/0357513 – cited in prior action), hereinafter Katra.
Regarding Claim 21, Ehrensberger in view of Dacey and Deutsch teaches the method of claim 11 as stated above. The modified Ehrensberger does not specifically teach that the wireless communication device transmits the alert to a clinician system, and wherein the device communicates bi-directionally with the clinician system.
Katra teaches techniques for remote monitoring of a patient and corresponding medical devices, involving communication between medical devices 17, computing devices 2, and edge devices (user/client devices for interfacing with patient/medical devices) 12 (see abstract, ¶[0046], ¶[0048]-[0051], ¶[0072]; Figs. 1 and 3), in the computing device 2 may comprise a clinician’s device, so as to receive data and alerts from the medical devices 17 and/or the edge devices 12 (see ¶[0065], ¶[0109], and ¶[0132]; Figs. 1 and 3). Note the bi-directional communication between the computing device 2 and the medical devices 17 and/or the edge devices 12 depicted in Fig. 3.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the bi-directional communication to a clinician’s device/system of Katra with the wireless communications device of the modified Ehrensberger because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) communication of alerts to the clinician would allow the clinician to receive patient data easier/more often over the internet, as opposed via the implanted device directly; and/or (3) the bi-directional communication would allow the clinician to communicate with the patient and/or the implanted medical device.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Ehrensberger in view of Dacey, Pringle, and Deutsch as applied to claim 13 above, and in view of van der Borden.
Regarding Claim 16, Ehrensberger in view of Dacey, Pringle, and Deutsch teaches the method of claim 13 as stated above. Ehrensberger further teaches the power source is connected to an implant connector that is connected to the at least one conductive percutaneous implant (¶[0036] the electrical lead 14, or ¶[0045] the sterile wire or needle to contact the implant; Figs. 1 and 8-9).
The modified Ehrensberger teaches that the implant may comprise a pin (see Ehrensberger ¶[0029] and ¶[0044]) but does not specifically teach that the implant connector has a body, a first electrode, and a second electrode, the body supporting the first electrode and the second electrode, the first electrode engaging the at least one conductive percutaneous implant, and the second electrode engaging the skin of the patient, and wherein the first electrode is electrically isolated from the second electrode.
Van der Borden teaches a device/method utilized on a goat model for treating implant infections; however, it is evident throughout the paper that the method is being tested and intended for a human model (pg. 2122 §1 ¶1 reconstructive bone surgery, pg. 2123 §1 ¶3 current is safe for human application). Van der Borden teaches a power source that is connected to an implant connector (see pg. 2123 §2.2, the polycarbonate canister; Fig. 1C) that is sized and dimensioned to be connected to a conductive percutaneous implant (see Fig. 1C); in which the implant connector has a body (see pg. 2123 §2.2, the body of the polycarbonate canister; Fig. 1C), a first electrode (see pg. 2123 §2.2, the cathode; Fig. 1C), and a second electrode (see pg. 2123 §2.2, the anode; Fig. 1C); the body supporting the first electrode and the second electrode (see Fig. 1C), the first electrode positioned to engage the first conductive percutaneous implant (see Fig. 1C, the pin cathode) and the second electrode positioned to engage a skin of the patient (see Fig. 1C, the ring anode that engages the skin). Here, van der Borden does not explicitly teach “the first electrode being electrically isolated from the second electrode”; however, this is inherent to the circuit because the electrodes would need to be electrically isolated from one another or the circuit would short.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the electrode integrated implant connector of van der Borden with the implant pin embodiment of the modified Ehrensberger because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) the usage of such an implant connector would obviate the need for the medical professional caring for the patient to manually setup and connect the electrodes to the implant and patient.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ehrensberger in view of Dacey, Pringle, and Deutsch as applied to claim 13 above, and in view of Shor.
Regarding Claim 17, Ehrensberger in view of Dacey and Pringle teaches the method of claim 13 as stated above. Ehrensberger further teaches the power source of the device includes a reference electrode within the circuit (¶[0031]-[0044] the reference electrode), the reference electrode having an implant connector (¶[0036] the electrical lead 14, or ¶[0045] the sterile wire or needle to contact the implant; Figs. 1 and 8-9).
The modified Ehrensberger is silent regarding that the reference electrode is connected to a second conductive orthopedic percutaneous implant.
Shor teaches a system and method for monitoring a patient site of interest, such as a surgical implant, for infections (see abstract and ¶[0083]; Fig. 1), in which a monitoring electrode and a reference electrode may be utilized (see ¶[0048]-[0052]), and that the reference electrode may be deployed at a different site of interest and/or implantable (see ¶[0052]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the reference electrode location at a second implant of Shor with the power source and reference electrode of the modified Ehrensberger because (1) it is the application of a known technique with a known method ready for improvement to yield predictable results and/or (2) including the reference electrode at a different site would allow the output of the reference electrode be used as reference to the output of the working electrode (see Shor ¶[0052]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ehrensberger in view of Dacey, Pringle, and Deutsch as applied to claim 18 above, and in view of Katra.
Regarding Claim 22, Ehrensberger in view of Dacey, Pringle, and Deutsch teaches the method of claim 18 as stated above. The modified Ehrensberger does not specifically teach that the wireless communication device transmits the alert to a clinician system, and wherein the device communicates bi-directionally with the clinician system.
Katra teaches techniques for remote monitoring of a patient and corresponding medical devices, involving communication between medical devices 17, computing devices 2, and edge devices (user/client devices for interfacing with patient/medical devices) 12 (see abstract, ¶[0046], ¶[0048]-[0051], ¶[0072]; Figs. 1 and 3), in the computing device 2 may comprise a clinician’s device, so as to receive data and alerts from the medical devices 17 and/or the edge devices 12 (see ¶[0065], ¶[0109], and ¶[0132]; Figs. 1 and 3). Note the bi-directional communication between the computing device 2 and the medical devices 17 and/or the edge devices 12 depicted in Fig. 3.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the bi-directional communication to a clinician’s device/system of Katra with the wireless communications device of the modified Ehrensberger because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) communication of ale