DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
2. According to the Amendment, filed 30 December 2025, the status of the claims is as follows:
Claims 1 and 5 are currently amended; and
Claims 2-4, 6, and 7 are as originally filed.
3. The objection of claim 5 because of minor informalities is withdrawn in view of the Amendment, filed 30 December 2025.
Response to Arguments
4. Applicant’s arguments, see Remarks, pp. 5-9, filed 30 December 2025, with respect to the rejection of claims 1-7 under pre-AIA 35 U.S.C. 102(b) as being anticipated by Mann et al., U.S. Patent Application Publication No. 2002/0055761 A1 (“Mann”), have been fully considered, and are persuasive in view of the Amendment, filed 30 December 2025. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection, which was necessitated by amendment, is discussed below.
Claim Rejections - 35 USC § 103
5. 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.
6. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
7. This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
8. Claims 1-7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mann et al., U.S. Patent Application Publication No. 2002/0055761 A1 (“Mann”), in view of Sormann et al., U.S. Patent Application Publication No. 2006/0161225 A1 (“Sormann”).
As to Claim 1, Mann teaches the following:
A method for the use of an electronic device implantable in the muscle of an animal (see “The systems and methods taught also include the injection, direct implantation, endoscopic, or laparoscopic implantation of one or more battery- or radio-frequency-powered microstimulators on or near the tibial nerve.” in para. [0055]), comprising:
implanting an electrode assembly (“capsule”) 11 including a pair of spaced-apart electrodes (“electrodes”) 14 and 16 each adapted and configured to be in electrical communication with a nerve in the muscle of the animal (see “Thus, when electrodes and/or catheters of a stimulator are implanted, for example, near the dorsal nerve of the clitoris (a branch of the pudendal nerve), the signals from an EMG sensor built into the stimulator may be used to adjust stimulation parameters.” in para. [0154]), an electrical circuit (“electronic circuitry”) 12, an electrical storage device (“power source and/or power storage device”) 15, an antenna (“antenna coil”) 22, and a transmitter (“integrate circuit (IC) chip”, not labeled), the electrode assembly 11 having a cross sectional diameter of 3 mm or less (see “Capsule 11 preferably has a diameter no greater than about 3-4 mm, and more preferably only about 1.5 mm.” in para. [0098]; and see “In a preferred embodiment, electronic circuitry 12 includes an inductive coil for receiving and transmitting RF data and/or power, an integrated circuit (IC) chip for decoding and storing stimulation parameters and generating stimulation pulses (either intermittent or continuous), and additional discrete electronic components that may be required to complete the electronic circuit functions, e.g., capacitor(s), resistor(s), coil(s), and the like.” in para. [0090]);
storing electrical energy via [RF] coupling by the antenna at a first predetermined frequency (see “When it is required to communicate with implanted stimulator 10, patient 170 is positioned on or near external appliance 190, which appliance contains one or more inductive coils 192 or other means of communication (e.g., RF transmitter and receiver). External appliance 190 is connected to or is a part of external electronic circuitry appliance 200 which receives power 202 from a conventional power source.” in para. [0157]);
detecting electromyogram (EMG) signals at source of the EMG signals (see “For instance, the muscle activity produced in response to stimulation may be detected, e.g., via recording of the associated electromyograph (EMG).” in para. [0154]); and
transmitting by the antenna 22 a processed version of the detected EMG signals (see “Function 3: Transmit sensed data indicating a need for treatment or in response to stimulation (e.g., pressure, neural activity (e.g., ENG), muscle activity (e.g., EMG), impedance, or other activity) to external appliance 200 via external appliance 190.” in para. [0163]).
Mann does not teach the following:
storing electric energy via electric field coupling by the antenna at a first predetermined frequency.
However, this feature for power transfer in medical implant systems is well-known in the art at the time of the invention. For example, Sormann teaches the following:
storing electric energy via electric field coupling by the antenna at a first predetermined frequency (see “… (b) an antenna based device locatable at the second position to receive an output from the transmitter, said antenna based device including a capacitor, wherein the power source is adapted to emit high frequency electromagnetic radiation between 0.5 to 5 GHz; and wherein, in use, the antenna based device converts the transmitted power to electrical energy which is used to operate the antenna based device, wherein the primary controller and the antenna based device do not communicate by inductive coupling; and wherein the primary controller is capable of transmitting power to the antenna based device from at least about 50 cm.” in claim 1; and see “In particular, the preferred range of high frequency electromagnetic radiation is 0.8 to 3.5 GHz. In one preferred embodiment the high frequency electromagnetic radiation is 0.8 to 2.5 GHz. In another embodiment, the preferred range is 1.5 to 3.5 GHz. This high frequency electromagnetic radiation is receivable by the antenna on the implanted device and used as a source of electrical energy to power the device as well as being capable of carrying an information signal to operate the implanted device.” in para. [0085]).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Mann’s RF coupling for power transfer to use electric field coupling, as taught by Sormann. Sormann suggests the modification by disclosing that there is a need for effective medical implant system which operates in the far field region (see Sormann, para. [0068]), and that incorporating electric field coupling by an antenna at frequency range between 0.8 to 3.5 GHz provides for this need (see Sormann, para. [0079]; and see “In particular, the preferred range of high frequency electromagnetic radiation is 0.8 to 3.5 GHz. In one preferred embodiment the high frequency electromagnetic radiation is 0.8 to 2.5 GHz. In another embodiment, the preferred range is 1.5 to 3.5 GHz. This high frequency electromagnetic radiation is receivable by the antenna on the implanted device and used as a source of electrical energy to power the device as well as being capable of carrying an information signal to operate the implanted device.” in Sormann, para. [0085]). Thus, Sormann provides the technical improvement to Mann’s device. Furthermore, Sormann is analogous art to Mann, as Sormann is also directed to an implantable muscle stimulation system using measurement of EMG signals by an EMG sensor (see “According to a further embodiment of the invention, there is provided an artificial muscle stimulation system comprising at least one stimulating electrode for providing artificial electrical stimulation to a muscle under control of a primary controller capable of transmitting high frequency electromagnetic radiation between 0.5 to 5 GHz, an EMG sensor for measuring EMG signals from the muscle during stimulation, a neural network processor coupled to receive the measured EMG signals to extract information regarding force of contraction and fatigue of the muscle, and wherein the primary controller is coupled to an output of the neural network processor to control said artificial electrical stimulation based on said extracted information.” in para. [0135]).
As to Claim 2, Mann teaches the following:
wherein said storing is performed by rectifying the received RF signal (see “Microstimulator 10, and all stimulators configured in accordance with the present invention (e.g., see FIG. 5), preferably contains electronic circuitry 12 for receiving data and/or power from outside the body by inductive, RF, or other electromagnetic coupling. In a preferred embodiment, electronic circuitry 12 includes an inductive coil for receiving and transmitting RF data and/or power, an integrated circuit (IC) chip for decoding and storing stimulation parameters and generating stimulation pulses (either intermittent or continuous), and additional discrete electronic components that may be required to complete the electronic circuit functions, e.g., capacitor(s), resistor(s), coil(s), and the like.” in para. [0090]).
As to Claim 3, Mann teaches the following:
wherein the electrodes 14 and 16 are spaced apart by less than about fifteen millimeters (see “Capsule length is preferably no greater than about 20-25 mm, and more preferably only about 10-12 mm.” in para. [0098], and see distance between “electrodes 14 and 16” in fig. 4).
As to Claim 4, Mann teaches the following:
wherein the electrodes 14 and 16 are spaced apart by more than about one millimeter (see “Capsule length is preferably no greater than about 20-25 mm, and more preferably only about 10-12 mm.” in para. [0098], and see distance between “electrodes 14 and 16” in fig. 4).
As to Claim 5, Mann teaches the following:
which further comprises powering the electrical circuit 12 by the electrical storage device 15 (see “In a preferred embodiment illustrated in FIG. 1, electronic circuitry 12 receives operating power, recharge power for the battery (if a rechargeable battery is included within the stimulator), and data to be stored in memory element 18 by inductive coupling from external controller 20 and its associated antenna coil 22. During an initial programming session after implantation of stimulator 10, the prescribing physician uses a programming station 30 to download a pattern of stimulus pulse delivery to controller 20, which saves the information in nonvolatile memory. Each time stimulator(s) 10 are recharged by controller 20, the stimulation parameters required from each stimulator 10 are transmitted via coil 22, along with the power required for recharging. The stimulation parameters are stored in memory element 18 of each stimulator 10 as long as power storage device 15 has sufficient power to operate the stimulator circuitry.” in para. [0093]).
As to Claim 6, Mann teaches the following:
wherein the electrical storage device 15 includes an ion absorption-type supercapacitor (see “Possible power options for a stimulation device(s) of the present invention, described in more detail below, include but are not limited to an external power source coupled to the stimulation device, e.g., via an RF link, a self-contained power source utilizing any means of generation or storage of energy (e.g., a primary battery, a replenishable or rechargeable battery such as a lithium ion battery, an electrolytic capacitor, or a super- or ultra-capacitor), and if the self-contained power source is replenishable or rechargeable, means of replenishable or recharging the power source (e.g., an RF link).” in para. [0092]).
As to Claim 7, Mann teaches the following:
wherein the electrical storage device 15 includes a dielectric effect supercapacitor (see “Possible power options for a stimulation device(s) of the present invention, described in more detail below, include but are not limited to an external power source coupled to the stimulation device, e.g., via an RF link, a self-contained power source utilizing any means of generation or storage of energy (e.g., a primary battery, a replenishable or rechargeable battery such as a lithium ion battery, an electrolytic capacitor, or a super- or ultra-capacitor), and if the self-contained power source is replenishable or rechargeable, means of replenishable or recharging the power source (e.g., an RF link).” in para. [0092]).
Conclusion
9. 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 02/24/2026