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 .
This Office Action is responsive to the Amendment filed 22 December 2026. Claims 1 - 15 are now pending. The Examiner acknowledges the amendments to claims 1 – 3, 9, 11 and 14.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 12 - 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites the limitation "the inversion" in line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests to amend to “the inversion circuit” if that is applicant’s intention.
Claim 12, line 4, it is unclear what the inversion refers to. Examiner suggests to amend to “the inversion circuit” if that is applicant’s intention.
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.
Claims 1 – 3, 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Cinbis et al (US 20170100036 A1, hereinafter “Cinbis”) in view of Mueller (US 5161540 A).
Regarding claim 1, Cinbis teaches an implantable medical device (“a sensing device 12, a communication hub 14”, [0015], Figure 1), comprising:
an electronic functional device (“Communication circuitry 38”, [0022], Figure 2) for performing a function of said implantable medical device,
said electronic functional device having an operational state for performing said function and a switched-off state (“Communication circuitry 38 is normally powered off via switch 40 and will be transitioned from a low power state, which may be an “off” state”, [0022], [0023], Figure 2), and
a wake-up device (“Control processor 32”, [0021] – [0026], Figure 2) for transferring said electronic functional device from said switched-off state to said operational state ([0022] – [0024]),
wherein the wake-up device comprises a first timer circuit (“Control processor 32”, [0021] – [0024]) for repeatedly transferring the electronic functional device into the operational state according to a first timing scheme (“scheduled”, [0026]),
a detection device (“an implant/calibration condition sensor”, [0024]) for detecting a signal from a signal source external (“External device 16 is used to program or send commands to sensing device 12 via hub 14.”, [0019]) to the implantable medical device (“an implant or calibration condition is detected by an implant/calibration condition sensor”, [0024]), and
a second timer circuit (“clock signal 46 or other timing circuitry”, [0022], Figure 2) for repeatedly transferring the detection device into a reception state according to a second timing scheme (“beacon listening”, [0026]).
Cinbis does not teach wherein the electronic functional device does not revert to said switch-off state until conclusion of a measurement performed in the operational state.
However, Mueller discloses “a device for monitoring a patient for rejection reactions of an implanted heart” (column 1, lines 9 - 10) and teaches wherein the electronic functional device does not revert to said switch-off state until conclusion of a measurement performed in the operational state (“. After the measuring cycle programmed in the control and recording device 28 has elapsed, the component 24 is turned off again by an OFF signal transmitted by the control and recording device 28 so that the battery in the component 24 is subjected to a minimum load.” column 3, lines 47 - 53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Cinbis such that the electronic functional device does not revert to said switch-off state until conclusion of a measurement performed in the operational state, as taught by Mueller, for the benefit of preserving the battery for future usage and not wasting energy (Mueller: column 3, lines 47 - 53).
Regarding claim 2, Cinbis and Mueller teach all limitations of claim 1. The modified invention of Cinbis and Mueller teaches the first timer circuit is configured to periodically transfer the electronic functional device into the operational state ([0025]).
Regarding claim 3, Cinbis and Mueller teach all limitations of claim 1. The modified invention of Cinbis and Mueller teaches the first timer circuit comprises an oscillator circuit adapted to generate a clock signal for determining a point in time to transfer the electronic functional device to the operational state ([0025], [0026]; Examiner interprets the timing signal for scheduled data transmissions is ultimately based on an oscillator signal.).
Regarding claim 11, Cinbis and Mueller teach all limitations of claim 1. The modified invention of Cinbis and Mueller teaches the detection device is configured to generate a signal which depends on the detection of the signal of the signal source ([0026]).
Regarding claim 14, Cinbis and Mueller teach all limitations of claim 1. The modified invention of Cinbis and Mueller teaches the electronic functional device, after being transferred to the operational state, remains in the operational state for a predetermined period of time for carrying out said function and then reverts to the switched-off state (Figure 7).
Claims 1 – 3, 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lebel et al (WO 03008014 A2, hereinafter “Lebel”) in view of Mueller (US 5161540 A).
Regarding claim 1, Lebel teaches an implantable medical device (“implantable device 2”, page 30 line 12), comprising:
an electronic functional device (“CPU 912”, page 56 line 3) for performing a function of said implantable medical device (page 52, lines 6 - 8)
said electronic functional device having an operational state for performing said function and a switched-off state (page 52, lines 6 - 8), and
a wake-up device (“timer module 924”, page 56 line 4) for transferring said electronic functional device from said switched-off state to said operational state (page 75, lines 5 – 16 and 21 - 31),
wherein the wake-up device comprises a first timer circuit (“timer module 924”, page 56 line 4) for repeatedly transferring the electronic functional device into the operational state according to a first timing scheme (page 75, lines 5-16 and 21-31 ),
a detection device (“RF Module 930”, page 76 line 33) for detecting a signal from a signal source external to the implantable medical device (page 76, line 33 - page 77, line 4), and
a second timer circuit for repeatedly transferring the detection device into a reception state according to a second timing scheme (page 77, lines 5 - 15).
Lebel does not teach wherein the electronic functional device does not revert to said switch-off state until conclusion of a measurement performed in the operational state.
However, Mueller discloses “a device for monitoring a patient for rejection reactions of an implanted heart” (column 1, lines 9 - 10) and teaches wherein the electronic functional device does not revert to said switch-off state until conclusion of a measurement performed in the operational state (“. After the measuring cycle programmed in the control and recording device 28 has elapsed, the component 24 is turned off again by an OFF signal transmitted by the control and recording device 28 so that the battery in the component 24 is subjected to a minimum load.” column 3, lines 47 - 53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lebel such that the electronic functional device does not revert to said switch-off state until conclusion of a measurement performed in the operational state, as taught by Mueller, for the benefit of preserving the battery for future usage and not wasting energy (Mueller: column 3, lines 47 - 53).
Regarding claim 2, Lebel and Mueller teach all limitations of claim 1. The modified invention of Lebel and Mueller teaches the first timer circuit is configured to periodically transfer the electronic functional device into the operational state (page 75, lines 5-16 and 21-31).
Regarding claim 3, Lebel and Mueller teach all limitations of claim 1. The modified invention of Lebel and Mueller teaches the first timer circuit comprises an oscillator circuit adapted to generate a clock signal for determining a point in time to transfer the electronic functional device to the operational state (page 73, lines 4-14).
Regarding claim 8, Lebel and Mueller teach all limitations of claim 1. The modified invention of Lebel and Mueller teaches the second timer circuit is configured to periodically switch the detection device to the reception state for a predetermined reception period (page 77, lines 5-15).
Regarding claim 14, Lebel and Mueller teach all limitations of claim 1. The modified invention of Lebel and Mueller teaches the electronic functional device, after being transferred to the operational state, remains in the operational state for a predetermined period of time for carrying out said function and then reverts to the switched-off state (page 52, lines 6-8).
Claims 1 – 2, 8 – 9, 11 - 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts et al (US 20100219351 A1, hereinafter “Roberts”) in view of Mueller (US 5161540 A).
Regarding claim 1, Roberts teaches an implantable medical device (“implantable medical device (IMD)” abstract, [0040], Figure 2), comprising:
an electronic functional device (“sensing module 26”, [0040], [0044] – [0045], Figure 2) for performing a function of said implantable medical device (Figure 2)
said electronic functional device (26) having an operational state for performing said function and a switched-off state ([0030] – [0031], [0040], [0048]), and
a wake-up device (“telemetry module 30 and radiation-based timer 32” [0040] [0045] – [0049] Figure 2 and “Radiation-based timer 40” [0064] Figure 3) for transferring said electronic functional device from said switched-off state to said operational state ([0048], [0068]),
wherein the wake-up device comprises a first timer circuit (“radiation-based timer 32”, [0040] [0045] – [0049]) for repeatedly transferring the electronic functional device into the operational state ([0048], [0068]) according to a first timing scheme ([0069]),
a detection device (“telemetry module 30”, [0045] – [0049]) for detecting a signal from a signal source external (“with the aid of an antenna, which may be internal and/or external”, [0046]) to the implantable medical device ([0046]), and
a second timer circuit (“Radiation-based timer 40”) for repeatedly transferring the detection device into a reception state ([0047], [0068]) according to a second timing scheme ([0069]). Examiner interprets it would be obvious to use different timer circuits if different intervals are required, as evident in Roberts: paragraph [0069].
Roberts does not teach wherein the electronic functional device does not revert to said switch-off state until conclusion of a measurement performed in the operational state.
However, Mueller discloses “a device for monitoring a patient for rejection reactions of an implanted heart” (column 1, lines 9 - 10) and teaches wherein the electronic functional device does not revert to said switch-off state until conclusion of a measurement performed in the operational state (“. After the measuring cycle programmed in the control and recording device 28 has elapsed, the component 24 is turned off again by an OFF signal transmitted by the control and recording device 28 so that the battery in the component 24 is subjected to a minimum load.” column 3, lines 47 - 53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Roberts such that the electronic functional device does not revert to said switch-off state until conclusion of a measurement performed in the operational state, as taught by Mueller, for the benefit of preserving the battery for future usage and not wasting energy (Mueller: column 3, lines 47 - 53).
Regarding claim 2, Roberts and Mueller teach all limitations of claim 1. The modified invention of Roberts and Mueller teaches the first timer circuit is configured to periodically transfer the electronic functional device into the operational state ([0048], [0068]).
Regarding claim 8, Roberts and Mueller teach all limitations of claim 1. The modified invention of Roberts and Mueller teaches the second timer circuit is configured to periodically switch the detection device to the reception state for a predetermined reception period ([0047], [0068]).
Regarding claim 9, Roberts and Mueller teach all limitations of claim 1. The modified invention of Roberts and Mueller teaches the detection device comprises a detection sensor for detecting the signal from the signal source ([0025], [0050] – [0051], [0055], Figures 3 and 4).
Regarding claim 11, Roberts and Mueller teach all limitations of claim 1. The modified invention of Roberts and Mueller teaches the detection device is configured to generate a signal which depends on the detection of the signal of the signal source ([0051]).
Regarding claim 12, Roberts and Mueller teach all limitations of claim 11. The modified invention of Roberts and Mueller teaches the wake-up device comprises an inversion circuit for inverting the signal generated by the detection device and for outputting an inverted signal obtained by the inversion (“These elements may be discrete sensors or incorporated directly into circuit elements such as inverters or storage cells”, [0050]).
Regarding claim 14, Roberts and Mueller teach all limitations of claim 1. The modified invention of Roberts and Mueller teaches the electronic functional device, after being transferred to the operational state, remains in the operational state for a predetermined period of time for carrying out said function and then reverts to the switched-off state ([0047], [0048]).
Claims 4 - 6 are rejected under 35 U.S.C. 103 as being unpatentable over Cinbis in view of Faltys et al (US 20160331952 A1, hereinafter “Faltys”).
Regarding claim 4, Cinbis and Mueller teach all limitations of claim 3. The modified invention of Cinbis and Mueller teaches the oscillator circuit ([0025], [0026]; Examiner interprets the timing signal for scheduled data transmissions is ultimately based on an oscillator signal.) but does not teach an RC oscillator.
However, Faltys discloses an “external programmer, such as an external clock synchronization tool, can be used to update or modify the stimulation protocol and/or parameters on an implanted electrical stimulator” (abstract) and teaches an RC oscillator (“RC oscillator”, [0111]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Cinbis and Mueller such that the oscillator circuit comprises an RC oscillator, as taught by Faltys, for the benefit of having lower power consumption (Faltys: [0111]).
Regarding claim 5, Cinbis and Mueller teach all limitations of claim 3. The modified invention of Cinbis and Mueller teaches the first timer circuit but does not teach a calibration oscillator for calibrating the oscillator circuit.
However, Faltys discloses an “external programmer, such as an external clock synchronization tool, can be used to update or modify the stimulation protocol and/or parameters on an implanted electrical stimulator” (abstract) and teaches a calibration oscillator ([0153] – [0159]). The limitation “for calibrating the oscillator circuit” is intended use. Since Faltys teaches the device performing calibration of a first clocking mechanism, ([0153]), the device of Faltys is capable of performing the intended use as claimed. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Cinbis and Mueller to incorporate teaches the first timer circuit comprises a calibration oscillator for calibrating the oscillator circuit, as taught by Faltys, for the benefit of “maintain an accurate clock in the implant in order to reliably deliver programmed stimulations at the scheduled times” (Faltys: [0153]).
Regarding claim 6, Cinbis, Mueller and Faltys teach all limitations of claim 5. The modified invention of Cinbis, Mueller and Faltys teaches the first timer circuit is configured to repeatedly calibrate the oscillator circuit using the calibration oscillator according to a calibration time scheme ([0153] – [0159]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Cinbis, Mueller and Faltys, as applied in claim 5, in view of Steffen (DE 3541106 A1, see attached).
Regarding claim 7, Cinbis, Mueller and Faltys teach all limitations of claim 5. The modified invention of Cinbis, Mueller and Faltys teaches the calibration oscillator (Faltys: [0153] – [0159]) but does not teach a quartz oscillator.
However, Steffen discloses a “device for generating currents for electotherapeutic treatment” (abstract) and teaches a quartz oscillator (page 3 paragraph 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Cinbis, Mueller and Faltys such that the calibration oscillator is formed by a quartz oscillator, as taught by Steffen, for the benefit of providing constant frequencies (page 2 paragraph 13).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Roberts and Mueller, as applied in claim 9, in view of Ostroff et al (US 20180161576 A1, hereinafter “Ostroff”).
Regarding claim 10, Roberts and Mueller teach all limitations of claim 9. The modified invention of Roberts and Mueller teaches the detection sensor ([0025], [0050] – [0051], [0055], Figures 3 and 4) but does not teach a GMR sensor.
However, Ostroff discloses “a miniature implantable neurostimulator system for sciatic nerves and their branches” (abstract) and teaches a GMR sensor ([0028], [0046], [0426] – [0427], [0432] – [0436]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Roberts and Mueller such that the detection sensor is formed by a GMR sensor, as taught by Ostroff, for the benefit of being “small, light, and reliable” (Ostroff: [0028]) and .
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Roberts and Mueller, as applied in claim 12, in view of Gord et al (WO 9912607 A1, hereinafter “Gord”).
Regarding claim 13, Roberts and Mueller teach all limitations of claim 12. The modified invention of Roberts and Mueller does not teach the inversion circuit is connected to the first timer circuit to output the inverted signal to the first timer circuit.
However, Gord discloses an “implantable sensor/stimulator” (abstract) and teaches an inversion circuit is connected to a first timer circuit to output the inverted signal to the first timer circuit (page 39 lines 19 – 24, Figure 9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Roberts and Mueller such that the inversion circuit is connected to the first timer circuit to output the inverted signal to the first timer circuit, as taught by Gord, for the benefit of “facilitate[ing] the powering and operation of the implantable sensor/stimulator” (Gord: pages 1 line 16 - 17).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Cinbis and Mueller, as applied in claim 1, in view of Kotlanka et al (US 20130053711 A1, hereinafter “Kotlanka”).
Regarding claim 15, Cinbis and Mueller teaches all limitations of claim 1. The modified invention of Cinbis and Mueller teaches the first timer circuit (“Control processor 32”, [0021] – [0024]) and/or the second timer circuit (“clock signal 46 or other timing circuitry”, [0022], Figure 2).
Cinbis does not teach at least one electronic component implemented in sub-threshold technology.
However, Kotlanka discloses “an implantable device” (abstract) and teaches at least one electronic component implemented in sub-threshold technology (“an 8-bit successive-approximation ADC register (SAR) 2100 with sub-threshold control logic, able to meet ultra low power requirements of an implantable device”, [0162]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Cinbis and Mueller to incorporate at least one electronic component implemented in sub-threshold technology, as taught by Kotlanka, as it is commonly used for low-power electronics (Kotlanka: [0162]).
Response to Arguments
Applicant’s arguments, see page 6, filed 22 December 2025, with respect to claim objections has been fully considered and is persuasive in light of the amendments. The claim objection for claim 1 of 30 September 2025 has been withdrawn.
Applicant’s arguments, see page 6, filed 22 December 2025, with respect to 35 U.S.C. 112 rejections have been fully considered and are persuasive. The 35 U.S.C. 112 rejections for claims 9 and 11 of 30 September 2025 have been withdrawn.
Applicant's arguments filed 22 December 2025 with respect to 35 U.S.C. 112 rejection of claim 12 has been fully considered but it is not persuasive. Claim 12 recites the limitation "the inversion" in line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests to amend to “the inversion circuit” if that is applicant’s intention.
Applicant’s arguments with respect to claim(s) 1 – 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. See rejections above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE T TRAN whose telephone number is (703)756-4677. The examiner can normally be reached Monday - Friday from 8:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE THI TRAN/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791