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.
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.
Claim(s) 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Eggers((US 20060020313 A1) in view of Gleich(US 20200400509 A1).
Regarding claim 1, Eggers discloses a device for detecting working status of a medical implant wherein the working status relates to a clinical function of the medical implant, wherein the medical implant is implanted into a body of a subject, wherein a micro device is integrated in and/or attached to the medical implant, wherein the micro device comprises a magneto-mechanical oscillator configured to transduce a magnetic excitation field into a magnetic response field, wherein the magneto-mechanical oscillator is adapted such that the magnetic response field is indicative of a temperature change of the micro device, wherein the device comprises; a transmit/receive unit adapted to i) generate the magnetic excitation field for exiting the magneto-mechanical oscillator, ii) detect the magnetic response field, and iii) transduce the detected magnetic response field of the magneto-mechanical oscillator into an electric response signal, and a controller adapted to control the transmit/receive unit, wherein the controller is further adapted to determine a change in a temperature of the micro device based on the electric response signal of the magneto-mechanical oscillator, and to determine the working status of the medical implant based on the determined change in the temperature of the micro device(Controller 38 additionally controls the output of the heating assembly 32 as is represented by arrow 40. In general, the heating carried out by the heating unit 32 may be enhanced through the utilization of heating elements implanted within the zone of the target tissue volume 26[0150]. The present invention employs temperature sensing untethered implants which are located within a target tissue volume, whereupon, using any of the above-discussed extra body heating systems the untethered implants will provide a quite accurate readout of preselected temperature levels. These temperature sensing implants are configured as passive resonant circuits with an inductor component and a capacitor component configured as a resonant circuit. That circuit is caused to ring at a known unique resonant center frequency while the tissue being monitored is at monitor temperatures below a target Curie temperature. When the predetermined setpoint (Curie-based) temperature for the tissue is reached, then the known resonating center frequency abruptly terminates[0152]. Such investigations have established critical temperature and time relationships which identify the occurrence of irreversible tissue damage effects. In this regard, looking to FIG. 3, a generalized semi-log curve 24 is presented illustrating the temporal relationship between the duration of the application of a given temperature to tissue with the value of that critical temperature at which irreversible tissue damage may occur. The system and method of the present invention are concerned, inter alia, with maintaining the treatment of target tissue volumes at accurately controlled temperatures for all heat-based therapies including hyperthermia[0126][Fig. 3].As represented at bus arrow 186 and block 188 resultant implant status data is asserted to a graphical user interface or readout assembly to provide visibly discernable information to the operator. Signals to instruct the system to commence carrying out an excitation and sensing sequence may be evolved from the data acquisition function 180. Such signal introduction is represented at arrow 190[0185]). Eggers fails to explicitly state the micro device contains a magneto-mechanical oscillator to detect and transduce magnetic fields.
However, Gleich teaches “The invention relates to a measurement device 1 comprising a rotatable magnetic object 4 which can oscillate with a resonant frequency if excited by an external magnetic torque. The measurement device 1 is adapted such that the resonant frequency depends on the temperature or on another physical or chemical quantity like pressure, in order to allow for a wireless temperature measurement or measurement of the other physical or chemical quantity via an external magnetic field providing the external magnetic torque. This measurement device can be relatively small, can be read-out over a relatively larger distance and allows for a very accurate measurement[abstract]”.
It would be obvious to one of ordinary skill in the art before the effective date to configure the system and method for evaluating tissue temperatures of Eggers with the magnetic oscillator of the measurement device of Gleich. Doing so would specify the magnetic element of the measuring and heating system of the implant device to allow for proper temperature adjustments and measurement.
Regarding claim 2, Eggers in view of Gleich teaches the device according to claim 1, wherein the device further comprises a heating unit adapted to heat the medical implant and/or an environment of the medical implant to cause a temperature change of the medical implant by a predetermined temperature value that is measurable by the micro device(Eggers - The present invention employs temperature sensing untethered implants which are located within a target tissue volume, whereupon, using any of the above-discussed extra body heating systems the untethered implants will provide a quite accurate readout of preselected temperature levels. That circuit is caused to ring at a known unique resonant center frequency while the tissue being monitored is at monitor temperatures below a target Curie temperature. When the predetermined setpoint (Curie-based) temperature for the tissue is reached, then the known resonating center frequency abruptly terminates[0152]. In one embodiment of the invention one or more of the sensor implants are configured to exhibit Curie transitions at a lower threshold setpoint temperature, while an additional one or more are configured to exhibit Curie transitions at an upper limit higher setpoint temperature. Thus, the practitioner will be apprised of the target tissue volume reaching that minimum temperature adequately for therapy, as well as of any temperature excursions above the upper limit. Where such thermal excursions occur, the heating unit involved may be adjusted, for example, in terms of power level as well as component positioning[0063]).
Regarding claim 3, Eggers in view of Gleich teaches the device according to claim 2, wherein the heating unit is adapted to apply a changing magnetic field to the medical implant and/or the environment of the medical implant for heating the medical implant(Eggers - It may be recalled in that figure that with a high magnetic field intensity applied to the sensors or auto-regulating heaters, the Curie transition range will soften[0240]).
Regarding claim 4, Eggers in view of Gleich teaches the device according to claim 1, wherein the controller is adapted to determine the temperature change of the micro device as a temperature curve over a predetermined time period and wherein the controller is adapted to determine the working status based on the determined temperature curve(Referring to FIG. 10C, actual sensor performance in a bath of water which was heated over a period of time is plotted with respect to temperatures and sensor output signal strength ratio for two sensors. A thermocouple was plotted with each sensor and the time/temperature plots thereof are shown at curves 216 and 217[0189]).
Regarding claim 5, Eggers on view of Gleich teaches the device according to claim 1, wherein the device further comprises a heating unit adapted to heat the medical implant and/or an environment of the medical implant to cause a temperature change of the medical implant by a predetermined temperature value that is measurable by the micro device, wherein the controller is adapted to determine the temperature change of the micro device as a temperature curve over predetermined time period during the heating and/or after the termination of the heating of the medical implant, wherein the controller is further adapted to compare the determined temperature curve with a calibration temperature curve determined during the same time period with respect to the heating of the medical implant, wherein the calibration temperature curve has been determined during a predetermined calibration time after the medical implant has been placed, wherein the controller is further adapted to determine the working statis based on the comparison(Controller 38 additionally controls the output of the heating assembly 32 as is represented by arrow 40. In general, the heating carried out by the heating unit 32 may be enhanced through the utilization of heating elements implanted within the zone of the target tissue volume 26[0150]. The present invention employs temperature sensing untethered implants which are located within a target tissue volume, whereupon, using any of the above-discussed extra body heating systems the untethered implants will provide a quite accurate readout of preselected temperature levels. These temperature sensing implants are configured as passive resonant circuits with an inductor component and a capacitor component configured as a resonant circuit. That circuit is caused to ring at a known unique resonant center frequency while the tissue being monitored is at monitor temperatures below a target Curie temperature. When the predetermined setpoint (Curie-based) temperature for the tissue is reached, then the known resonating center frequency abruptly terminates[0152]. Such investigations have established critical temperature and time relationships which identify the occurrence of irreversible tissue damage effects. In this regard, looking to FIG. 3, a generalized semi-log curve 24 is presented illustrating the temporal relationship between the duration of the application of a given temperature to tissue with the value of that critical temperature at which irreversible tissue damage may occur. The system and method of the present invention are concerned, inter alia, with maintaining the treatment of target tissue volumes at accurately controlled temperatures for all heat-based therapies including hyperthermia[0126][Fig. 3].As represented at bus arrow 186 and block 188 resultant implant status data is asserted to a graphical user interface or readout assembly to provide visibly discernable information to the operator. Signals to instruct the system to commence carrying out an excitation and sensing sequence may be evolved from the data acquisition function 180. Such signal introduction is represented at arrow 190[0185]).
Regarding claim 6, Eggers in view of Gleich teaches the device according to claim 5, wherein the comparison comprised determining fit parameters for the temperature curve and the calibration temperature curve, wherein fit parameters determine a fit of a predetermined mathematical function to a temperature curve, and further comprises comparing the fit parameters of the temperature curve and of calibration temperature curve for determining the working status of the medical implant(Such investigations have established critical temperature and time relationships which identify the occurrence of irreversible tissue damage effects. In this regard, looking to FIG. 3, a generalized semi-log curve 24 is presented illustrating the temporal relationship between the duration of the application of a given temperature to tissue with the value of that critical temperature at which irreversible tissue damage may occur[0126]. Curve 22 reveals that the relative magnetic permeability, .mu..sub.r, decreases as the temperature of the ferromagnetic alloy heater approaches its Curie temperature, T.sub.c. Since the induced electric field heating power in an object is proportional to the square root of magnetic permeability, a decrease in magnetic permeability with elevation of temperature is associated with a corresponding decrease in the heating power associated with inductive heating[0122]. Traditionally, the change in magnetic permeability of ferromagnetic alloys with increasing temperature has not been abrupt as would be preferred for precise temperature regulation of an implanted heating component as at 16. In this regard, characteristic curve 22 reveals that under the relatively intense, applied fields a permeability transition occurs gradually over a span typically of 10.degree. C. to 15.degree. C. or more[0123]).
Regarding claim 7, Eggers in view of Gleich teaches the device according to claim 6, wherein the controller is further adapted to provide a suggestion for a clinical decision based on the working status(As represented at line 2224 and block 2226 a determination is made as to whether the stop therapy switch or button 1604' (FIG. 37) has been pressed or actuated. In the event that it has, then as represented at line 2230 and block 2232 the heating unit is turned off, red LED 1598 is illuminated and green LED 1598' is illuminated and green 1600' is turned off (FIG. 37). Next, as represented at line 2234 and block 2236 the practitioner determines whether or not therapy is to be resumed[0283]).
Regarding claim 8, Eggers in view of Gleich teaches the device according to claim 1, wherein a plurality of micro devices are integrated in and/or attached to the medical implant at different positions, wherein the controller is adapted to determine based on the plurality of the electric response signals associated with the plurality of micro devices a temperature change of each of the micro devices and to determine a working status of the medical implant based on the plurality of determined temperature changes(the determining of the boundaries or periphery and the physiological state of a target tissue volume, the practitioner will determine the number of implants called for and their positioning within the localized tissue region. In effect, the location of the implants can be mapped such that their resonating responses or lack thereof may be utilized in conjunction with the map to adjust the aiming feature of the external heating system. Referring to FIG. 18, the periphery of a target tissue volume is schematically represented at 800. Within this tissue periphery 800 there are located twelve implants[0224]. A control circuit responsive to derive said excite signal for said excitation interval, subsequently responsive to enable said detector assembly to permit derivation of said amplified output; a data acquisition and control network responsive to sample and digitize said amplified output to provide digitized waveform data, to derive frequency intensity signals therefrom about the center frequencies of each said unique resonant electromagnetic response when a said implant is at a said monitor temperature or temperatures, responsive to said frequency intensity signals and implant identification data representing a corresponding unique resonant electromagnetic response to derive implant status data; and a readout assembly responsive to said implant status data to provide a discernable readout corresponding therewith[claim 119]).
Regarding claim 9, Eggers in view of Gleich teaches the device according to claim 1, wherein the medical implant refers to a bone implant and wherein the working status of the medical implant refers to a bone implant and wherein the working status of the medical implant refers to a failure state indicative of the potential failure of the bone implant(The implant control heating approach of the invention also may be applied to the field of orthopedics. In this regard, the sensor components may be combined in intimate thermal exchange relationship with non-magnetic metal bone support devices implanted with bony tissue. The setpoint temperature elected for such modality is selected to enhance the repair of the mending bony tissue[0066]).
Regarding claim 10, Eggers in view of Gleich teaches the device according to claim 1, wherein the medical implant refers to a medical stent and wherein the working status of the medical implant refers to an overgrowth status of the stent indicative of an amount of tissue covering the medical stent(Additionally, the coating may be activated in the event the patient's symptoms or diagnostic methods indicate that restenosis is occurring and progressing to the point that therapeutic intervention is warranted[0271]).
Regarding claim 11, Eggers in view of Gleich teaches a system for detecting a working status of a medical implant, wherein the medical implant is implanted into a body of a subject, wherein the system comprises a device according to claim 1, but Eggers fails to explicitly state and further comprising the micro device configured to be integrated and/or attached to the medical implant, wherein the micro device comprises a magneto-mechanical oscillator configure to transduce a magnetic excitation field into a magnetic response field, wherein the magneto-mechanical oscillator is adapted such that the magnetic response field is indicative of a temperature change of the micro device.
However, Gleich teaches “In step 401 a magnetic field is generated which provides a magnetic torque for rotating the magnetic object 4 of the measurement device 1 within the subject 40 out of its equilibrium orientation and for thereby exciting a rotational oscillation of the magnetic object 4 such that it oscillates with the resonant frequency of the rotational oscillation of the magnetic object 4. Moreover, in step 401 induction signals are generated, which are caused by the rotational oscillation of the magnetic object 4. In particular, the magnetic field is generated with different excitation frequencies including the resonant frequency. Thus, although the resonant frequency is initially unknown and should be determined, it is known in which frequency range the resonant frequency will likely be present, wherein the magnetic field is generated with excitation frequencies covering the known frequency range in which the resonant frequency is to be expected. In step 402 the temperature or the other physical or chemical quantity, respectively, is determined based on the generated induction signals and in step 403 the determined temperature or other physical or chemical quantity, respectively, is outputted[0054]”.
It would be obvious to one of ordinary skill in the art before the effective date to configure the system and method for evaluating tissue temperatures of Eggers with the magnetic oscillator of the measurement device of Gleich. Doing so would specify the magnetic element of the measuring and heating system of the implant device to allow for proper temperature adjustments and measurement.
Regarding claim 12, Eggers in view of Gleich teaches a medical implant adapted to be usable in a system according to claim 11, wherein the medical implant comprises a micro device integrated with and/or attached to the medical implant(. Additionally, as represented at line 1722 and block 1724 a prompt is presented at display 1588 indicating that cable attachments should be checked and the procedure returns to line 1714 as represented at line 1726. Where the interrogation assembly status is ok, then as represented at line 1728 and block 1730 green LED 1590 is illuminated. Next, as represented at line 1732 and block 1734 the heating unit is actuated following which, as represented at line 1736 and block 1738, the control system acquires on and continuity status of the heating unit and determines, as represented at line 1740 and block 1742, whether that status is ok[0255]).
Regarding claim 13, Eggers in view of Gleich teaches a controller for being utilized in a system for detecting a working status of a medical implant, wherein the working status is indicative of an ability of the medical implant to perform its intended task, and wherein the medical implant is implanted into a body of a subject, wherein the system comprises a) a micro device being integrated and/or attached to the medical implant, wherein the micro device comprises a magneto-mechanical oscillator configured to transduce a magnetic excitation field into a magnetic response field, wherein the magneto-mechanical oscillator is adapted such that the magnetic response field is indicative of temperature change of the micro device, and b) a transmit/receive unit adapted to i) generate the magnetic excitation field for exiting the magneto-mechanical oscillator, ii) detect the magnetic response field, and iii) transduce the magnetic response filed of the magneto-mechanical oscillator into an electric response signal, wherein the controller is adapted to determine a change in temperature of the micro device based on an electric response signal of the magneto-mechanical oscillator, and to determine the working status of the medical implant based on the determined change in the temperature of the micro device(Controller 38 additionally controls the output of the heating assembly 32 as is represented by arrow 40. In general, the heating carried out by the heating unit 32 may be enhanced through the utilization of heating elements implanted within the zone of the target tissue volume 26[0150]. The present invention employs temperature sensing untethered implants which are located within a target tissue volume, whereupon, using any of the above-discussed extra body heating systems the untethered implants will provide a quite accurate readout of preselected temperature levels. These temperature sensing implants are configured as passive resonant circuits with an inductor component and a capacitor component configured as a resonant circuit. That circuit is caused to ring at a known unique resonant center frequency while the tissue being monitored is at monitor temperatures below a target Curie temperature. When the predetermined setpoint (Curie-based) temperature for the tissue is reached, then the known resonating center frequency abruptly terminates[0152]. Such investigations have established critical temperature and time relationships which identify the occurrence of irreversible tissue damage effects. In this regard, looking to FIG. 3, a generalized semi-log curve 24 is presented illustrating the temporal relationship between the duration of the application of a given temperature to tissue with the value of that critical temperature at which irreversible tissue damage may occur. The system and method of the present invention are concerned, inter alia, with maintaining the treatment of target tissue volumes at accurately controlled temperatures for all heat-based therapies including hyperthermia[0126][Fig. 3].As represented at bus arrow 186 and block 188 resultant implant status data is asserted to a graphical user interface or readout assembly to provide visibly discernable information to the operator. Signals to instruct the system to commence carrying out an excitation and sensing sequence may be evolved from the data acquisition function 180. Such signal introduction is represented at arrow 190[0185]). Eggers fails to explicitly state the micro device contains a magneto-mechanical oscillator to detect and transduce magnetic fields.
However, Gleich teaches “The invention relates to a measurement device 1 comprising a rotatable magnetic object 4 which can oscillate with a resonant frequency if excited by an external magnetic torque. The measurement device 1 is adapted such that the resonant frequency depends on the temperature or on another physical or chemical quantity like pressure, in order to allow for a wireless temperature measurement or measurement of the other physical or chemical quantity via an external magnetic field providing the external magnetic torque. This measurement device can be relatively small, can be read-out over a relatively larger distance and allows for a very accurate measurement[abstract]”.
It would be obvious to one of ordinary skill in the art before the effective date to configure the system and method for evaluating tissue temperatures of Eggers with the magnetic oscillator of the measurement device of Gleich. Doing so would specify the magnetic element of the measuring and heating system of the implant device to allow for proper temperature adjustments and measurement.
Regarding claim 14, Eggers in view of Gleich teaches a method for detecting a working status of a medical implant, wherein the working status is indicative of an ability of the medical implant to perform its intended task, and wherein the medical implant is implanted into a body of a subject and comprises a micro device, wherein the micro device comprises: controlling a transmit/receive unit to i) generate the magnetic excitation field for exiting the magneto-mechanical oscillator, ii) detect the magnetic response field, and iii) transduce the magnetic response field of the magneto-mechanical oscillator into an electric response signal, determining a change in a temperature of the micro device based on an electric response signal of the magneto-mechanical oscillator, and determining the working status of the medical implant based on the determined change in the temperature of the micro device((Controller 38 additionally controls the output of the heating assembly 32 as is represented by arrow 40. In general, the heating carried out by the heating unit 32 may be enhanced through the utilization of heating elements implanted within the zone of the target tissue volume 26[0150]. The present invention employs temperature sensing untethered implants which are located within a target tissue volume, whereupon, using any of the above-discussed extra body heating systems the untethered implants will provide a quite accurate readout of preselected temperature levels. These temperature sensing implants are configured as passive resonant circuits with an inductor component and a capacitor component configured as a resonant circuit. That circuit is caused to ring at a known unique resonant center frequency while the tissue being monitored is at monitor temperatures below a target Curie temperature. When the predetermined setpoint (Curie-based) temperature for the tissue is reached, then the known resonating center frequency abruptly terminates[0152]. Such investigations have established critical temperature and time relationships which identify the occurrence of irreversible tissue damage effects. In this regard, looking to FIG. 3, a generalized semi-log curve 24 is presented illustrating the temporal relationship between the duration of the application of a given temperature to tissue with the value of that critical temperature at which irreversible tissue damage may occur. The system and method of the present invention are concerned, inter alia, with maintaining the treatment of target tissue volumes at accurately controlled temperatures for all heat-based therapies including hyperthermia[0126][Fig. 3].As represented at bus arrow 186 and block 188 resultant implant status data is asserted to a graphical user interface or readout assembly to provide visibly discernable information to the operator. Signals to instruct the system to commence carrying out an excitation and sensing sequence may be evolved from the data acquisition function 180. Such signal introduction is represented at arrow 190[0185]). Eggers fails to explicitly state the micro device contains a magneto-mechanical oscillator to detect and transduce magnetic fields.
However, Gleich teaches “The invention relates to a measurement device 1 comprising a rotatable magnetic object 4 which can oscillate with a resonant frequency if excited by an external magnetic torque. The measurement device 1 is adapted such that the resonant frequency depends on the temperature or on another physical or chemical quantity like pressure, in order to allow for a wireless temperature measurement or measurement of the other physical or chemical quantity via an external magnetic field providing the external magnetic torque. This measurement device can be relatively small, can be read-out over a relatively larger distance and allows for a very accurate measurement[abstract]”.
It would be obvious to one of ordinary skill in the art before the effective date to configure the system and method for evaluating tissue temperatures of Eggers with the magnetic oscillator of the measurement device of Gleich. Doing so would specify the magnetic element of the measuring and heating system of the implant device to allow for proper temperature adjustments and measurement.
Regarding claim 15, Eggers in view of Gleich teaches the method according to claim 14, wherein the method further comprises heating the medical implant and/or an environment of the medical implant to cause a temperature change of the medical implant by a predetermined temperature value that is measurable by the micro device(The present invention employs temperature sensing untethered implants which are located within a target tissue volume, whereupon, using any of the above-discussed extra body heating systems the untethered implants will provide a quite accurate readout of preselected temperature levels. That circuit is caused to ring at a known unique resonant center frequency while the tissue being monitored is at monitor temperatures below a target Curie temperature. When the predetermined setpoint (Curie-based) temperature for the tissue is reached, then the known resonating center frequency abruptly terminates[0152]. In one embodiment of the invention one or more of the sensor implants are configured to exhibit Curie transitions at a lower threshold setpoint temperature, while an additional one or more are configured to exhibit Curie transitions at an upper limit higher setpoint temperature. Thus, the practitioner will be apprised of the target tissue volume reaching that minimum temperature adequately for therapy, as well as of any temperature excursions above the upper limit. Where such thermal excursions occur, the heating unit involved may be adjusted, for example, in terms of power level as well as component positioning[0063]).
Regarding claim 16, Eggers in view of Gleich teaches the method according to claim 14, wherein the method further comprises: heating the medical implant and/or an environment of the medical implant to cause a temperature change of the medical implant by a predetermined temperature value that is measurable by the micro device, determining the temperature change of the micro device as a temperature curve over a predetermined time period during or after the termination of the heating of the medical implant, comparing the determined temperature curve with a calibration temperature curve determined during the same time period with respect to the heating of the medical implant, wherein the calibration temperature curve has been determined during a predetermined calibration time after the medical implant has been placed, and determining the working status based on the comparison(Controller 38 additionally controls the output of the heating assembly 32 as is represented by arrow 40. In general, the heating carried out by the heating unit 32 may be enhanced through the utilization of heating elements implanted within the zone of the target tissue volume 26[0150]. The present invention employs temperature sensing untethered implants which are located within a target tissue volume, whereupon, using any of the above-discussed extra body heating systems the untethered implants will provide a quite accurate readout of preselected temperature levels. These temperature sensing implants are configured as passive resonant circuits with an inductor component and a capacitor component configured as a resonant circuit. That circuit is caused to ring at a known unique resonant center frequency while the tissue being monitored is at monitor temperatures below a target Curie temperature. When the predetermined setpoint (Curie-based) temperature for the tissue is reached, then the known resonating center frequency abruptly terminates[0152]. Such investigations have established critical temperature and time relationships which identify the occurrence of irreversible tissue damage effects. In this regard, looking to FIG. 3, a generalized semi-log curve 24 is presented illustrating the temporal relationship between the duration of the application of a given temperature to tissue with the value of that critical temperature at which irreversible tissue damage may occur. The system and method of the present invention are concerned, inter alia, with maintaining the treatment of target tissue volumes at accurately controlled temperatures for all heat-based therapies including hyperthermia[0126][Fig. 3].As represented at bus arrow 186 and block 188 resultant implant status data is asserted to a graphical user interface or readout assembly to provide visibly discernable information to the operator. Signals to instruct the system to commence carrying out an excitation and sensing sequence may be evolved from the data acquisition function 180. Such signal introduction is represented at arrow 190[0185]).
Regarding claim 17, Eggers in view of Gleich teaches the method according to claim 16, wherein the comparison comprises determine fit parameters for the temperature curve and the calibration temperature curve, wherein fit parameters determine a fit of a predetermined mathematical function to a temperature curve, and further comprises comparing the fit parameters of the temperature curve and of the calibration temperature curve for determining the working status of the medical implant(Such investigations have established critical temperature and time relationships which identify the occurrence of irreversible tissue damage effects. In this regard, looking to FIG. 3, a generalized semi-log curve 24 is presented illustrating the temporal relationship between the duration of the application of a given temperature to tissue with the value of that critical temperature at which irreversible tissue damage may occur[0126]. . Curve 22 reveals that the relative magnetic permeability, .mu..sub.r, decreases as the temperature of the ferromagnetic alloy heater approaches its Curie temperature, T.sub.c. Since the induced electric field heating power in an object is proportional to the square root of magnetic permeability, a decrease in magnetic permeability with elevation of temperature is associated with a corresponding decrease in the heating power associated with inductive heating[0122]. Traditionally, the change in magnetic permeability of ferromagnetic alloys with increasing temperature has not been abrupt as would be preferred for precise temperature regulation of an implanted heating component as at 16. In this regard, characteristic curve 22 reveals that under the relatively intense, applied fields a permeability transition occurs gradually over a span typically of 10.degree. C. to 15.degree. C. or more[0123]).
Regarding claim 18, Eggers in view of Gleich teaches the method according to claim 17, wherein the method further comprises providing a suggestion for a clinical decision based on the working status(As represented at line 2224 and block 2226 a determination is made as to whether the stop therapy switch or button 1604' (FIG. 37) has been pressed or actuated. In the event that it has, then as represented at line 2230 and block 2232 the heating unit is turned off, red LED 1598 is illuminated and green LED 1598' is illuminated and green 1600' is turned off (FIG. 37). Next, as represented at line 2234 and block 2236 the practitioner determines whether or not therapy is to be resumed[0283]).
Regarding claim 19, Eggers in view of Gleich teaches a non-transitory computer readable medium detecting a working status of a medical implant, wherein the computer readable medium has instructions stored thereon that when executed by a device, a processor or processing device cause the device, the processor or the processing device to execute the method according to claim 14(A non-transitory computer readable medium configured to store a computer program comprising machine executable instructions for causing a read-out system to carry out the steps of the measuring method as defined in claim 14, when the computer program is run on a computer controlling the read-out system, wherein the read out system includes: an excitation and induction signal unit adapted to: a) generate a magnetic field providing a magnetic torque for rotating the magnetic object of the measurement device out of its equilibrium orientation and for thereby exciting a rotational oscillation of the magnetic object such that it oscillates with the resonant frequency, and b) generate induction signals that are caused by the rotational oscillation of the magnetic object; and a determination unit adapted to determine the temperature or the other physical or chemical quantity based on the generated induction signals[claim 15]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796