DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
The Applicant filed Amendments to the Claims and Remarks on January 26, 2026 in response to Primary Examiner Mark W. Bockelman’s Requirement for Restriction/Election, dated November 24, 2025.
Amendments to the Claims
At this time, claims 1-17 are pending. Claims 18-20 have been cancelled. (Remarks, pg. 5)
Response to Restriction Requirement
The Applicant has elected Group I consisting of claims 1-17 without traverse.
Election/Restrictions
Applicant’s election without traverse of Group I, consisting of claims 1-17, in the reply filed on January 26, 2026 is acknowledged.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
reference character “148” has been used to designate both “transceiver circuitry” (Specification, pg. 9, para. [0034]) and “power source” (Specification, pg. 12, para. [0037]);
reference character “106” has been used to designate both “server” (Specification, pg. 8, para. [0029]) and “a networked computing device and/or a computer network” (Specification, pg. 12, para. [0039]); and
reference character “202A” has been used to designate both “first dose of electrical neurostimulation” (Specification, pg. 13, para. [0041]) and “therapeutic regimen” (Specification, pg. 13, para. [0042]).
The drawings are further objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
reference character “200’” as seen in Fig. 4B is not described in the Specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Drawings objections above regarding reference characters “148”, “106”, “202A” and “200’”; and
Specification, pg. 15, para. [0048] contains the typographical error of “If at 402, …”, which the Examiner believes is meant to recite “If at S402, …”.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-10, and 13-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ostroff et al. (US 2017/0173328, hereinafter referred to as Ostroff).
Regarding independent claim 1, Ostroff discloses a miniature implantable neurostimulator system for sciatic nerves and their branches. The implanted miniature neurostimulator is implanted in the leg and stimulates these nerves for the treatment of urinary or bowel incontinence. (Abstract) Ostroff further discloses an implantable neurostimulation device (Figs. 1-4; [0358]: “An exemplary miniature implanted neurostimulator is shown in FIG. 1.”), comprising:
circuitry for generating an electrical stimulation therapy (generator 1 in Figs. 1-4; [0358]: “The generator portion may be packaged in a cylindrical form, typically 1.0 cc in volume or less and no more than 6 to 7 mm in diameter. The generator (1) may comprise a primary cell (3), typically lithium CFx chemistry, an electronics compartment (4), an anchor (2), and a header (5).”);
one or more electrodes configured to deliver the electrical stimulation therapy to a targeted nerve of a patient (such as bipolar cuff electrode assembly 7 in Fig. 1; [0359]: “The cuff electrode assembly encircles the nerve to stimulate.”; [0362]; [0363]; [0366]-[0368]); and
at least one sensor configured to sense data used by the circuitry to infer a distance between the one or more electrodes and the targeted nerve, wherein the circuitry is configured to modify the electrical stimulation therapy based on the inferred distance between the one or more electrodes in the targeted nerve ([0029]: “An orientation or alignment of the implant may be detected, such as with an accelerometer of the implant. The generation of the stimulation signal may be disabled, postponed, or otherwise modified in response to the detected orientation or movement.”; [0395]: “FIG. 17 shows a state diagram for a low duty-cycle stimulator with deferred therapy (130). In this embodiment, an accelerometer may be included in the miniature implanted neurostimulator to detect limb movement.”; [0047]).
Regarding claim 2, Ostroff discloses that the implantable neurostimulation device is adapted for tibial nerve stimulation ([0018]: “… [the implant] is suitable for implantation near the posterior tibial nerve”).
Regarding claim 4, Ostroff discloses that the implantable neurostimulation device is configured to at least one of selectively increase or decrease an amplitude of the electrical stimulation therapy based on the inferred distance between the one or more electrodes in the targeted nerve ([0029]: “An orientation or alignment of the implant may be detected, such as with an accelerometer of the implant. The generation of the stimulation signal may be disabled, postponed, or otherwise modified in response to the detected orientation or movement.”).
Regarding claim 5, Ostroff discloses that the amplitude of the electrical stimulation therapy is variable in a range of between about 0.1 mA and about 25 mA ([0033]: “The circuitry may be configured to generate the stimulation signal to have a current in a range of between 19 mA and 1 mA, 18 mA and 2 mA, 17 mA and 3 mA, 16 mA and 4 mA, 15 mA and 5 mA, 14 mA and 6 mA, 13 mA and 7 mA, 12 mA and 8 mA, or 11 mA and 9 mA.”).
Regarding claim 6, Ostroff discloses that the one or more sensor is at least one of an accelerometer or electromyographic sensor ([0029]: “An orientation or alignment of the implant may be detected, such as with an accelerometer of the implant. The generation of the stimulation signal may be disabled, postponed, or otherwise modified in response to the detected orientation or movement.”; [0395]: “FIG. 17 shows a state diagram for a low duty-cycle stimulator with deferred therapy (130). In this embodiment, an accelerometer may be included in the miniature implanted neurostimulator to detect limb movement.”; [0047]).
Regarding claim 7, Ostroff discloses that the implantable neurostimulation device is configured to communicate with at least one of a mobile computing device, a desktop computer, smart watch, or a dedicated implantable neurostimulation device programmer ([0043]: “The external programmer may comprise one or more of a key fob, a smartphone, a smartwatch, a tablet computer, a laptop computer, a wearable computing device, a wand, a strap configured to at least partially encircle a limb of the subject, or other portable computing device. The external programmer may be in communication with a printing device to record a therapeutic protocol delivered by the implantable device.”; smart phone key fob/programmer system 165 via direct implant connection in Fig. 20; smart phone programmer system 170 via indirect implant connection in Fig. 21).
Regarding claim 8, Ostroff discloses that the implantable neurostimulation device is configured to selectively pause the electrical stimulation therapy in response to a user defined tactile command ([0395]: “If at any time during the therapy a leg movement is detected (137), the ENABLE STIM state can be exited to a 1 HR DELAY state. After 1 hour expires (136), simulation can be resumed by returning to the ENABLE STIM state (132). After 30 minutes of stimulation (135), the stimulator can transition back to IDLE state (131). “; “Leg Movement Detected” 137 in Fig. 17; [0419]: “An RF-based miniature implanted neurostimulator can also be activated by a patient operated key fob (140) as shown in FIG. 18. …The key fob may choose to distinguish between a single click, delayed hold, and a double click to send unique commands, or additional keys may be included on the key fob for unique commands.”; Figs. 18-19).
Regarding claim 9, Ostroff discloses that the at least one sensor is further configured to sense data used by the circuitry to infer receipt of a user defined tactile command ([0420]: “Activation of the key fob by the patient may result in a pre-programmed command to be executed by the miniature implanted neurostimulation. …More than one command may be available to be executed by the miniature implanted neurostimulator.”).
Regarding claim 10, Ostroff discloses that the implantable neurostimulation device is configured to at least one of pause the electrical stimulation therapy, skip an electrical stimulation therapy session, or change an amplitude of the electrical stimulation therapy in response to an inferred receipt of the user defined tactile command ([0395]: “If at any time during the therapy a leg movement is detected (137), the ENABLE STIM state can be exited to a 1 HR DELAY state. After 1 hour expires (136), simulation can be resumed by returning to the ENABLE STIM state (132). After 30 minutes of stimulation (135), the stimulator can transition back to IDLE state (131). “; “Leg Movement Detected” 137 in Fig. 17).
Regarding independent claim 13, Ostroff discloses an implantable neurostimulation system (Figs. 1-4; [0358]: “An exemplary miniature implanted neurostimulator is shown in FIG. 1.”), comprising:
an implantable neurostimulation device configured to deliver an electrical stimulation therapy to a targeted nerve of a patient via one or more electrodes (such as bipolar cuff electrode assembly 7 in Fig. 1; [0359]: “The cuff electrode assembly encircles the nerve to stimulate.”; [0362]; [0363]; [0366]-[0368]); and
an external sensor configured to sense patient activity inferring a change in distance between the one or more electrodes and the targeted nerve, wherein the implantable neurostimulation device is configured to modify the electrical stimulation therapy based on the inferred change in distance between the one or more electrodes in the targeted nerve ([0029]: “An orientation or alignment of the implant may be detected, such as with an accelerometer of the implant. The generation of the stimulation signal may be disabled, postponed, or otherwise modified in response to the detected orientation or movement.”; [0395]: “FIG. 17 shows a state diagram for a low duty-cycle stimulator with deferred therapy (130). In this embodiment, an accelerometer may be included in the miniature implanted neurostimulator to detect limb movement.”; [0047]).
Regarding claim 14, Ostroff discloses that the implantable neurostimulation device is adapted for tibial nerve stimulation ([0018]: “… [the implant] is suitable for implantation near the posterior tibial nerve”).
Regarding claim 15, Ostroff discloses that the external sensor is at least one of a heart rate monitor, pulse oximeter, respiratory sensor, perspiration sensor, posture orientation sensor, motion sensor, accelerometer, or microphone ([0029]: “An orientation or alignment of the implant may be detected, such as with an accelerometer of the implant. The generation of the stimulation signal may be disabled, postponed, or otherwise modified in response to the detected orientation or movement.”; [0395]: “FIG. 17 shows a state diagram for a low duty-cycle stimulator with deferred therapy (130). In this embodiment, an accelerometer may be included in the miniature implanted neurostimulator to detect limb movement.”; [0047]).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ostroff in view of Stein et al. (US 2005/0192645, hereinafter referred to as Stein).
Regarding claim 3, Ostroff is not specific to that the at least one sensor is configured to sense at least one of inversion, eversion, dorsiflexion, or plantar flexion in an ankle of the patient, though detecting orientation or alignment is disclosed ([0047]: “The implantable device may further comprise an accelerometer coupled to the circuitry. The accelerometer may be configured to detect an orientation or alignment of the implantable device or a movement of the subject. The circuitry may be configured to disable, postpone, or otherwise modify a therapeutic protocol of the implantable device in response to the detected orientation, alignment, or movement.”).
However, Stein teaches a method to produce a balanced dorsiflexion during the gait of patients with drop foot. Stein further teaches that the at least one sensor is configured to sense at least one of inversion, eversion, dorsiflexion, or plantar flexion in an ankle of the patient (tilt sensor 30 and foot sensor 34 in Fig. 5; [0041]: “In connection with the Walk Aide 2 hardware, a tilt of the leg shank backwards relative to the body at the end of the stance phase of the walking cycle activates tilt sensor circuitry 30 that sends a signal representing tilt angle to microcontroller 31. If the tilt signal exceeds a predetermined threshold and some other logic conditions are met, for example that stimuli have not been generated for a period known as the "Wait" period, a stimulus gate signal is generated”; [0043]: “…a tilt sensor 30 (Analog Devices ADXL202) measures the orientation of the leg with respect to gravity, a foot sensor 34 (Interlink Technology force sensing resistor FSR-20) measures the pressure of the heel on the ground…”; Fig. 4).
Stein is of a similar pursuit to that of the instant application in teaching an electrical therapeutic system having to do with ankle movement and nerve stimulation. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the sensor of Ostroff to include measuring at least one of inversion, eversion, dorsiflexion, or plantar flexion in an ankle of the patient in order to act as an input to controlling nerve stimulation.
Claims 11-12 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ostroff in view of Scott et al. (US 2014/0163644, hereinafter referred to as Scott).
Regarding claim 11, Ostroff is silent to that the at least one sensor is further configured to sense data used by the circuitry to infer operation of at least one of a vehicle or heavy machinery.
However, Scott teaches a minimally invasive implantable neurostimulation system, which is of a similar pursuit to that of the instant application. Scott further teaches that the at least one sensor is further configured to sense data used by the circuitry to infer operation of at least one of a vehicle or heavy machinery ([0093]: “…an activity sensor may be used in controlling therapy delivery by stopping or starting therapy delivery based on an activity signal. … such as operating a motor vehicle, walking, jogging, running, stair climbing, cycling etc.”; [0095]: “A detected activity state that corresponds to an intrinsic activation of the tibial nerve, stair climbing or driving an automobile, may cause a drive signal applied to the external coil to be withheld to inhibit the therapeutic electrical stimulation in response to the detected activity state.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the control parameters of Ostroff to include sensing the operation of a vehicle or heavy machinery to prevent unwanted or potentially dangerous neuromodulation in a patient.
Regarding claim 12, in view of the Ostroff/Scott combination, Ostroff is silent to that the implantable neural stimulation device is configured to selectively pause the electrical stimulation therapy in response to the inferred operation of at least one of a vehicle or heavy machinery.
However, Scott teaches discloses that the implantable neural stimulation device is configured to selectively pause the electrical stimulation therapy in response to the inferred operation of at least one of a vehicle or heavy machinery ([0093]: “…an activity sensor may be used in controlling therapy delivery by stopping or starting therapy delivery based on an activity signal. … such as operating a motor vehicle, walking, jogging, running, stair climbing, cycling etc.”; [0095]: “A detected activity state that corresponds to an intrinsic activation of the tibial nerve, stair climbing or driving an automobile, may cause a drive signal applied to the external coil to be withheld to inhibit the therapeutic electrical stimulation in response to the detected activity state.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the control parameters of Ostroff to include sensing the operation of a vehicle or heavy machinery to prevent unwanted or potentially dangerous neuromodulation in a patient.
Regarding claim 16, Ostroff is silent to that the at least one signal correlates to patient operation of at least one of an automobile or heavy machinery.
However, Scott teaches that the at least one signal correlates to patient operation of at least one of an automobile or heavy machinery ([0093]: “…an activity sensor may be used in controlling therapy delivery by stopping or starting therapy delivery based on an activity signal. … such as operating a motor vehicle, walking, jogging, running, stair climbing, cycling etc.”; [0095]: “A detected activity state that corresponds to an intrinsic activation of the tibial nerve, stair climbing or driving an automobile, may cause a drive signal applied to the external coil to be withheld to inhibit the therapeutic electrical stimulation in response to the detected activity state.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the control parameters of Ostroff to include sensing the operation of a vehicle or heavy machinery to prevent unwanted or potentially dangerous neuromodulation in a patient.
Regarding claim 17, in view of the Ostroff/Scott combination, Ostroff is silent to that the implantable neurostimulation device is configured to selectively pause the electrical stimulation therapy.
However, Scott teaches that the implantable neurostimulation device is configured to selectively pause the electrical stimulation therapy ([0093]: “…an activity sensor may be used in controlling therapy delivery by stopping or starting therapy delivery based on an activity signal. … such as operating a motor vehicle, walking, jogging, running, stair climbing, cycling etc.”; [0095]: “A detected activity state that corresponds to an intrinsic activation of the tibial nerve, stair climbing or driving an automobile, may cause a drive signal applied to the external coil to be withheld to inhibit the therapeutic electrical stimulation in response to the detected activity state.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the control parameters of Ostroff to include sensing the operation of a vehicle or heavy machinery to prevent unwanted or potentially dangerous neuromodulation in a patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Alme et al. (US 2010/0185183);
Hahn et al. (US 2012/0143286); and
Yoo et al. (US 2019/0126039).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY G SCHLUETER whose telephone number is (703)756-4601. The examiner can normally be reached M-F 9:00am-5:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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