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 .
Election/Restrictions
Claims 18-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention II and Species B, there being no allowable generic or linking claim.
The Applicant elected Invention I without traverse in the Response filed 12 November 2025, directed to Claims 1-17 and 25 (see Page 8 of Response).
The Applicant timely traversed the Species A and B election requirement in the Response filed 12 November 2025. The traversal is on the grounds that Species A and B are not mutually exclusive (see Pages 8-9 of Response). However, the Examiner does not find these arguments persuasive. As described in the Election/Restriction Requirement mailed 22 October 2025, Species A is directed to a rechargeable implantable neurostimulator embodiment comprising two or more sensors, and a controller configured to control generation of neurostimulation signals from the waveform generator to at least one electrode (see Examples/Embodiments 1 and/or 2 in the instant Specification, Paragraph [0006]-[0007] Claims 1-17), whereas Species B is directed to a rechargeable implantable neurostimulator embodiment comprising an external device configured to wirelessly charge and communicate with the stimulator, including at least one sensor for use in determining temperature (see Example/Embodiment 25 in the instant Specification, Paragraph [0030]; Claim 25). Therefore, Species A and B are independent or distinct because each of Species A and B is directed to distinct embodiments of rechargeable implantable neurostimulators, with different features and modes of operation, since Species A is directed to a rechargeable implantable neurostimulator embodiment comprising two or more sensors, and a controller configured to control generation of neurostimulation signals from the waveform generator to at least one electrode, whereas Species B is directed to a rechargeable implantable neurostimulator embodiment comprising an external device configured to wirelessly charge and communicate with the stimulator, including at least one sensor for use in determining temperature. In addition, these species are not obvious variants of each other based on the current record.
The Examiner will consider a Rejoinder of non-elected Invention II and Species B (Claims 18-25) when allowable subject matter has been indicated.
Thus, Claims 1-17 are presently under consideration.
Claim Objections
Claims 2 and 4-7 are objected to because of the following informalities:
Claims 2 and 4-7 all recite “the two or more temperature sensors”. However, Claim 1 and other claims recite “two or more sensors”. Claims 2 and 4-7 should be amended to recite “the two or more sensors” for consistency for this limitation within the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4-8, and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gerber et al. (US Publication No. 2009/0005770).
Regarding Claim 1, Gerber et al. discloses a rechargeable implantable neurostimulator for subcutaneous implantation and for managing heat during recharge (Abstract; Paragraph 0002, 0025; Fig. 1), comprising:
a neurostimulation waveform generator configured to generate neurostimulation signals (neurostimulators, Paragraph 0002, 0012, 0025, 0037; nerve stimulator 22, 20, 62 of Figs. 1-3);
at least one electrode (therapy delivery element/lead 24, 40, Figs. 1-3);
at least one rechargeable battery configured to power the rechargeable implantable neurostimulator (rechargeable power source/battery 58, Figs. 4A-C; Paragraph 0037-0038, 0045);
a coil for receiving power (recharging/secondary coil 68, Figs. 1-4), wherein the coil is electrically connected to the circuitry for use in recharging the rechargeable battery using the power received by the coil (Paragraph 0037-0040);
two or more sensors (multiple temperature sensors, 50, 50’, Figs 1-4; Paragraph 0035, 0041-0042, 0044) configured for use in determining temperature;
a controller (processor 110, Fig. 3; electronics 40, Figs. 4A-C; Paragraph 0032, 0037-0041) configured to:
control generation of neurostimulation signals (processor 110, Fig. 3 and electronics 40 control recharging and therapy delivery, Figs. 4A-C; Paragraph 0025, 0032, 0037-0041) from the neurostimulation waveform generator to deliver neurostimulation using the at least one electrode (neurostimulators, Paragraph 0002, 0012, 0025, 0037; nerve stimulator 22, 20, 62 of Figs. 1-3);
perform sensor processing using the two or more sensors (multiple temperature sensors, 50, 50’, Figs 1-4; Paragraph 0035, 0041-0042, 0044) to determine a temperature event (see temperature event Flowcharts of Figs. 5-9; Paragraph 0044-0048);
and control recharging of the rechargeable battery using a recharging process (Abstract; Paragraph 0007-0009, 0024, 0030), including modify the recharging process to reduce heating in response to determining that the temperature event occurred (e.g. Low Temp. Recharge vs High Temp. Recharge, see temperature event Flowcharts of Figs. 5-9; Paragraph 0044-0048).
Regarding Claim 2, Gerber et al. discloses a rechargeable implantable neurostimulator further wherein the controller is configured to determine whether the temperature event occurs by measuring implant temperature from multiple sensor readings (multiple temperature sensors, 50, 50’, Figs 1-4; Paragraph 0035, 0041-0042, 0044), and validating sensor measurements (multiple sensors to validate and improve accuracy of sensor readings, Paragraph 0042).
Regarding Claim 4, Gerber et al. discloses a rechargeable implantable neurostimulator further wherein the two or more temperature sensors are positioned to detect temperature at different depths from tissue when the neurostimulator is subcutaneously implanted (sensors implanted at multiple locations inside or outside of housing: “Sensors 50, 50' may be disposed in or on, generally in proximity to, device 20 or portion thereof. Sensor 50, 50' may be exposed to an external surface of device 20 to be in contact with body tissue or fluid when implanted in a patient, or may be contained in housing 66, as appropriate.”, Paragraph 0041; “The use of more than one temperature sensor at different locations may serve to improve the accuracy of determinations as to whether temperature at a given sensor location is indicative of infection by comparing the temperature at the given location to temperature at a location removed from the given location.”, Paragraph 0042).
Regarding Claim 5, Gerber et al. discloses a rechargeable implantable neurostimulator further comprising a housing (housing 66, 20, 82, Figs. 1-4) for housing at least one of the neurostimulation waveform generator, the battery, the coil or the controller (see Figs. 1-4; Paragraph 0029, 0031, 0037-0040, 0044), wherein the two or more temperature sensors include an external temperature sensor configured to sense a temperature outside of the housing and an internal temperature sensor configured to sense a temperature inside of the housing (sensors implanted at multiple locations inside or outside of housing: “Sensors 50, 50' may be disposed in or on, generally in proximity to, device 20 or portion thereof. Sensor 50, 50' may be exposed to an external surface of device 20 to be in contact with body tissue or fluid when implanted in a patient, or may be contained in housing 66, as appropriate.”, Paragraph 0041; “The use of more than one temperature sensor at different locations may serve to improve the accuracy of determinations as to whether temperature at a given sensor location is indicative of infection by comparing the temperature at the given location to temperature at a location removed from the given location.”, Paragraph 0042).
Regarding Claims 6 and 7, Gerber et al. discloses a rechargeable implantable neurostimulator further wherein the two or more temperature sensors include a same type or a different type of temperature sensor (“Any suitable sensor 50, 50' capable of detecting temperature or changes in temperature may be employed. For example, temperature sensor 50, 50' may include a thermocouple, a thermistor, a junction-based thermal sensor, a thermopile, a fiber optic detector, an acoustic temperature sensor, a quartz or other resonant temperature sensor, a thermo-mechanical temperature sensor, a thin film resistive element, or the like.”, Paragraph 0030; see also Paragraph 0029, 0042).
Regarding Claim 8, Gerber et al. discloses a rechargeable implantable neurostimulator further wherein the controller is configured to perform sensing processing by receiving two or more signals corresponding to the two or more sensors (multiple temperature sensors, 50, 50’, Figs 1-4; Paragraph 0035, 0041-0042, 0044), and producing a fused sensor output using the two or more signals (multiple sensors with multiple sensor readings to validate and improve accuracy of sensor readings, Paragraph 0042), wherein the fused sensor output is indicative of whether the temperature event occurred (“use of more than one temperature sensor at different locations may serve to improve the accuracy of determinations”, Paragraph 0042; see also Paragraph 0021, 0030, 0043; “determination may be made by processor 110 by comparing information obtained by temperature sensor 50, 50' and stored in memory 120 to temperature range values stored in memory 120”, Paragraph 0047).
Regarding Claim 13, Gerber et al. discloses a rechargeable implantable neurostimulator further wherein the controller (processor 110, Fig. 3; electronics 40, Figs. 4A-C; Paragraph 0032, 0037-0041) is configured to modify the recharging process in response to the temperature event (e.g. Low Temp. Recharge vs High Temp. Recharge, see temperature event Flowcharts of Figs. 5-9; Paragraph 0008-0009, 0024, 0044-0048) by providing a signal to an external device to stop the external device from recharging the neurostimulator (“End Recharge”, see temperature event Flowcharts of Figs. 5-9; Paragraph 0044-0048); or detuning the implantable neurostimulator to reduce an amount of received energy to be dissipated as heat when the at least one rechargeable battery is fully charged (“Modify Recharge Parameters”, see temperature event Flowcharts of Figs. 5-9; Paragraph 0044-0048).
Regarding Claim 14, Gerber et al. discloses a rechargeable implantable neurostimulator further comprising: a metal can (titanium/metal can housing 66, 20, 82, Figs. 1-4; Paragraph 0037, 0044; “Housing 66 is hermetically sealed and manufactured from a biocompatible material such as titanium..”, Paragraph 0037) configured to house the neurostimulator waveform generator and the controller, wherein the metal can is configured to shield the neurostimulator waveform generator and the controller from electromagnetic interference (shield 70, Figs. 1-4; Paragraph 0037, 0040, 0044) and moisture ingress (hermetically sealed housing, Paragraph 0029, 0037-0039), and the coil (recharging/secondary coil 68, Figs. 1-4) is biocompatible and not housed within the metal can (see embodiments of Figs. 4A-C, wherein coil 68 is not housed within the same can/structure as the other electronics, Paragraph 0040-0043); and a housing configured to encapsulate the coil and the metal can (separate housing may encapsulate all structures, e.g., see 66, 76, 74, Figs. 4A-C; Paragraph 0040-0043), wherein the housing is non-conductive and biocompatible (e.g. materials such as ceramic, epoxy, polymer, Paragraph 0037, 0039).
Regarding Claim 15, Gerber et al. discloses a rechargeable implantable neurostimulator further wherein the housing includes an epoxy (“Housing 66 is hermetically sealed and manufactured from a biocompatible material such as titanium, epoxy, ceramic, and the like”, Paragraph 0037; “hermetic seal is a biocompatible material and can take many forms including potting material, polymer encapsulation, coil cover with polymer seal, or the like”, Paragraph 0039).
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.
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 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber et al. (US Publication No. 2009/0005770).
Regarding Claim 16, Gerber et al. discloses a rechargeable implantable neurostimulator further wherein the housing includes a number of biocompatible materials including epoxy or polymer (“Housing 66 is hermetically sealed and manufactured from a biocompatible material such as titanium, epoxy, ceramic, and the like”, Paragraph 0037; “hermetic seal is a biocompatible material and can take many forms including potting material, polymer encapsulation, coil cover with polymer seal, or the like”, Paragraph 0039). However, Gerber et al. does not explicitly disclose wherein the housing is flexible.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the housing to be flexible (e.g., a flexible biocompatible epoxy or polymer), for the purpose of to prevent stress breakage to the housing and/or to improve patient comfort of the implantable device, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Regarding Claim 17, Gerber et al. discloses a rechargeable implantable neurostimulator further wherein the housing (see 66, 76, 74 which surrounds all internal components, Figs. 4A-C; Paragraph 0040-0043) includes a first housing portion and a second housing portion; the first housing portion encapsulates the coil (recharging/secondary coil 68, in separate housing, see Figs. 4A-C, Figs. 1-4) and the second housing portion encapsulates the metal can (titanium/metal can housing 66, 20, 82, Figs. 1-4; Paragraph 0037, 0044).
As shown in Gerber et al. (see Figs. 4A-C), it appears that the coil housing and the titanium/metal can housing may be substantially equal in size (see Figs. 4A-C), and each of the first and second housing portions have a thickness, length and width (see Figs. 4A-C) to provide each of the first and second housing portions with a substantially planar major surface (planar surfaces/faces of housing portions 74, 76, 66, Figs. 4A-C; Paragraph 0037, 0040, 0041), wherein the first and second housing portions are joined such that the substantially planar major surfaces form right/90 degree angles (planar surfaces/faces of housing portions 74, 76, 66 form right/90 degree angles, see Figs. 4A-C; Paragraph 0037, 0040, 0041).
However, Gerber et al. does not explicitly disclose the first and second housing portions have substantially equal footprints, the thickness is less than the length and the width, wherein the first and second housing portions are joined such that the substantially planar major surfaces form an angle between 90 degrees and 180 degrees. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the first and second housing portions in the neurostimulator disclosed by Gerber et al. to have substantially equal footprints, and to configure the thickness to be less than the length and the width, wherein the first and second housing portions are joined such that the substantially planar major surfaces form an angle between 90 degrees and 180 degrees, since this would merely be a design choice of the housing structures. Gerber et al. discloses, “It will be understood that the components described in FIGS. 1-4 are but examples of components that an implantable device 20 may include and that many other device or system configurations may be employed” (Paragraph 0043). Such a modification to the size and shape of the housing portions would have involved a mere change in the form or shape of the housing components. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claims 3 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber et al. (US Publication No. 2009/0005770) in view of Vanslyke et al. (US Publication No. 2015/0351673).
Regarding Claim 9, Gerber et al. discloses a rechargeable implantable neurostimulator further wherein the controller is configured to perform sensing processing by receiving two or more signals corresponding to the two or more sensors (multiple temperature sensors, 50, 50’, Figs 1-4; Paragraph 0035, 0041-0042, 0044), and producing a fused sensor output using the two or more signals (multiple sensors with multiple sensor readings to validate and improve accuracy of sensor readings, Paragraph 0042), wherein the fused sensor output is indicative of whether the temperature event occurred (“use of more than one temperature sensor at different locations may serve to improve the accuracy of determinations”, Paragraph 0042; see also Paragraph 0021, 0030, 0043; “determination may be made by processor 110 by comparing information obtained by temperature sensor 50, 50' and stored in memory 120 to temperature range values stored in memory 120”, Paragraph 0047).
However, Gerber et al. does not explicitly disclose wherein the controller is configured to denoise the received two or more signals, and apply a model to at least one of the received two or more signals to provide a virtual sensor signal used to produce the fused sensor output.
Vanslyke et al. teaches a medical diagnostic sensing system (Abstract) wherein the controller (Paragraph 0453) is configured to denoise the received signals (removal of noise/filters, Paragraph 0016, 0184-0185, 0196), and apply a model to at least one of the received signals to provide a virtual sensor signal used to produce the fused sensor output (predictive signal modeling, Paragraph 0018, 0170, 0178, 0194, 0205, 0227). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the controller in the system disclosed by Gerber et al. to denoise the received two or more signals, and apply a model to at least one of the received two or more signals to provide a virtual sensor signal used to produce the fused sensor output, as taught by Vanslyke et al., in order to more accurately determine accurate sensor readings for diagnostics by potentially removing sensing noise/errors. See Vanslyke et al., Paragraph 0007-0008, 0010, 0018.
Regarding Claim 10, Gerber et al. discloses a rechargeable implantable neurostimulator further wherein the controller is configured to perform sensing processing by receiving two or more signals corresponding to the two or more sensors (multiple temperature sensors, 50, 50’, Figs 1-4; Paragraph 0035, 0041-0042, 0044), and producing a fused sensor output using the two or more signals (multiple sensors with multiple sensor readings to validate and improve accuracy of sensor readings, Paragraph 0042), wherein the fused sensor output is indicative of whether the temperature event occurred (“use of more than one temperature sensor at different locations may serve to improve the accuracy of determinations”, Paragraph 0042; see also Paragraph 0021, 0030, 0043; “determination may be made by processor 110 by comparing information obtained by temperature sensor 50, 50' and stored in memory 120 to temperature range values stored in memory 120”, Paragraph 0047).
However, Gerber et al. does not explicitly disclose wherein the controller is configured to weight the received two or more signals to produce the fused sensor output.
Vanslyke et al. teaches a medical diagnostic sensing system (Abstract) wherein the controller (Paragraph 0453) is configured to weight the received two or more signals to produce the fused sensor output (weighting signals for output, Paragraph 0210, 0212-0214, 0307, 0335). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the controller in the system disclosed by Gerber et al. to weight the received two or more signals to produce the fused sensor output, as taught by Vanslyke et al., in order to in order to more accurately determine accurate sensor readings for diagnostics by weighting higher quality and/or more indicative signal readings. See Vanslyke et al., Paragraph 0210, 0212-0214, 0307, 0335.
Regarding Claim 11, Gerber et al. discloses a rechargeable implantable neurostimulator further wherein the controller is configured to perform sensing processing by receiving two or more signals corresponding to the two or more sensors (multiple temperature sensors, 50, 50’, Figs 1-4; Paragraph 0035, 0041-0042, 0044), and producing a fused sensor output using the two or more signals (multiple sensors with multiple sensor readings to validate and improve accuracy of sensor readings, Paragraph 0042), wherein the fused sensor output is indicative of whether the temperature event occurred (“use of more than one temperature sensor at different locations may serve to improve the accuracy of determinations”, Paragraph 0042; see also Paragraph 0021, 0030, 0043; “determination may be made by processor 110 by comparing information obtained by temperature sensor 50, 50' and stored in memory 120 to temperature range values stored in memory 120”, Paragraph 0047).
However, Gerber et al. does not explicitly disclose wherein the controller is configured to perform sensor diagnostics and adjust production of the fused sensor output based on the performed sensor diagnostics.
Vanslyke et al. teaches a medical diagnostic sensing system (Abstract) wherein the controller (Paragraph 0453) is configured to perform sensor diagnostics and adjust production of the fused sensor output based on the performed sensor diagnostics (self-diagnostics routine and responsive processing of sensed signals, Paragraph 0018, 0191, 0208, 0266, 0270, 0359-0360, 0404-0405). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the controller in the system disclosed by Gerber et al. to perform sensor diagnostics and adjust production of the fused sensor output based on the performed sensor diagnostics, as taught by Vanslyke et al., in order to in order to more accurately determine accurate sensor readings for diagnostics by potentially removing or adjusting for sensing noise/errors. See Vanslyke et al., Paragraph 0018, 0191, 0208, 0266, 0270, 0359-0360, 0404-0405.
Regarding Claims 3 and 12, Gerber et al. discloses a rechargeable implantable neurostimulator further wherein the controller is configured to perform sensing processing by receiving two or more signals corresponding to the two or more sensors (multiple temperature sensors, 50, 50’, Figs 1-4; Paragraph 0035, 0041-0042, 0044), and producing a fused sensor output using the two or more signals (multiple sensors with multiple sensor readings to validate and improve accuracy of sensor readings, Paragraph 0042).
Gerber et al. does not explicitly disclose wherein the controller is configured to determine a sensor fault using the sensor readings, and adjust the sensor processing to account for the sensor fault when determining the temperature event, or wherein the sensor diagnostics include an anomaly detection process or a fault detection process, and the sensor diagnostics further include an isolation routine to: remove one or more of the two or more signals from being used to produce the fused sensor output; or reduce a weight for one or more of the two or more signals when used to produce the fused sensor output.
Vanslyke et al. teaches a medical diagnostic sensing system (Abstract) wherein the controller (Paragraph 0453) is configured to determine a sensor fault using the sensor readings (Paragraph 0016, 0017, 0179, 0188, 0190-0191), and adjust the sensor processing to account for the sensor fault when determining the signal event (self-diagnostics routine and responsive processing of sensed signals, Paragraph 0018, 0191, 0208, 0266, 0270, 0359-0360, 0404-0405), and wherein the sensor diagnostics include an anomaly detection process or a fault detection process (Paragraph 0016, 0017, 0179, 0188, 0190-0191), and the sensor diagnostics further include an isolation routine to: remove one or more of the two or more signals from being used to produce the fused sensor output (compensation of signal, Paragraph 0202, 0210, 0360-0364, 0380, 0382); or reduce a weight for one or more of the two or more signals when used to produce the fused sensor output (weighting signals for accuracy, Paragraph 0210, 0212-0214, 0307, 0335).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the controller in the system disclosed by Gerber et al. to determine a sensor fault using the sensor readings, and adjust the sensor processing to account for the sensor fault when determining the temperature event, or wherein the sensor diagnostics include an anomaly detection process or a fault detection process, and the sensor diagnostics further include an isolation routine to: remove one or more of the two or more signals from being used to produce the fused sensor output; or reduce a weight for one or more of the two or more signals when used to produce the fused sensor output, as taught by Vanslyke et al., in order to in order to more accurately determine accurate sensor readings for diagnostics by potentially removing or adjusting for sensing noise/errors/faults. See Vanslyke et al.,
Paragraph 0202, 0210, 0212-0214, 0307, 0335, 0360-0364, 0380, 0382.
Conclusion
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796