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
Applicant's election with traverse of Species A (directed to claims 1-17 and 35), in the reply filed on 07/21/2026 is acknowledged. The traversal is on the grounds that Applicant argues Examiner does not establish that the differences between the identified Species A and Species B would impose a serious search or examination burden. This is not found persuasive because Species A and Species B, while both associated with a wireless nerve stimulation system comprising an external flexible substrate and implantable lead, use entirely different methods of pulse generation and power transmission.
Species A has transmitter circuitry and a power source coupled to the external patch so that a power signal is transmitted to the implantable receiver and the implantable receiver comprises pulse generator circuitry to receive the power signal and use the power signal to generate a nerve stimulating pulse. In contrast, Species B has transmitter circuitry and pulse generator circuitry coupled to the external patch so that an electrical pulse signal is transmitted directly to the implantable lead for delivery of a nerve stimulating pulse.
Species A requires the pulse generator circuitry to be part of the implantable lead assembly so that power may be transmitted between the external stimulator assembly and the implantable stimulation assembly. Species B requires the pulse generator circuitry to be part of the external stimulator assembly so that the pulse signal itself may be transmitted between the external stimulator assembly and the implantable lead.
This difference is more than a mere rearrangement of parts as it requires different methods of signal transmission and pulse generation, which would lead to a serious search/examination burden on the Examiner.
The requirement is still deemed proper and is therefore made final.
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.
(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 1-8, 10, 11, 15, and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yakovlev et al (US 20200101291 A1).
Regarding claim 1, Yakovlev teaches a nerve stimulation device (2000 or 4100) comprising:
a flexible stimulator comprising circuitry supported on a flexible substrate (see [0039]; the at least one external device or patch comprises a flexible substrate configured to attach the at least on external device to the patient, [0248]; external device 2030 can take a form factor of a self-adhesive patch implemented on a flexible substrate 2610),
said stimulator comprising:
a wearable energy transmitter patch (see Fig. 26, [0248]; illustrating external device 2030 as flexible patch 2610, [0298]; external device 4100 may have a single enclosure which is attached to the surface of the skin through an adhesive, or using a belt, band, strap, or other attachment element)
said energy transmitter patch comprising:
a first flexible substrate (see [0248]; flexible substrate 2610 of external device 2030 or [0298]; belt, band, or strap of external device 4100);
a power source supported on said first flexible substrate (see [0248]; flexible substrate 2610 can include a battery and other circuitry 2630, [0298]; the enclosure of external device 4100 surrounds a power supple 4130); and
transmitter circuitry electrically coupled to said power source and supported on said first flexible substrate (see Fig. 22, [0236-0238], [0245]; transmission antenna 2210, transceiver 2270, Bluetooth or other standard communication protocol 2220, Fig. 37, [0299]; antennas 4150 each attached to relay or communication electronics 4160);
said transmitter circuitry defining an energy transmitter antenna (2210 or 4150) configured to transmit a power signal wirelessly from said power source (see [0238]; for wireless powering and communication using electromagnetic energy the external device 2030 uses one or more antennas 2210, [0296]; external device 4100 can transfer both power and data to the implantable device 4110); and
an implantable receiver (2010 or 4110),
said implantable receiver comprising:
a second flexible substrate (see [0219]; modulation interface components may be soft electrodes implemented on flexible, biocompatible printed circuit substrates);
receiver circuitry defining an energy receiver antenna (2110 or 4240) configured to receive the power signal transmitted from said wearable energy transmitter patch by said energy transmitter antenna (see [0236]; external device 2030 may include a transmission antenna 2210 that can be placed near the surface of the skin in close proximity to the antenna 2110 of the implantable device 2010, this link can transfer both power and data to the implantable device 2010, [0304]; antennas of the external device can be configured to operate implanted devices including transmitting power and/or communication to the implanted devices);
pulse generator circuitry (2180 or [0296]; implantable device 4110 can include a pulse generator) operatively connected to said receiver circuitry (Figs. 21 and 38) to receive the power signal and generate electrical pulses operative to mask pain signals from a nerve (see [0017-0019]; embodiments of the invention provide for precise, controlled modulation of specific nerves or tissues to induce physiological effects for therapies, the conditions to be treated include chronic and acute pain)
an implantable lead (2170 or 4220) comprising:
a first portion electrically coupled to said pulse generator circuitry to receive said electrical pulses (see Fig. 21; electrode or lead interface 2170 coupled to pulse generator 2180, [0307]; implantable device 4110 comprising one or more electrodes 4230, which may be part of lead 4220 and pulse generator circuitry); and
a second portion electrically coupled to said first portion and comprising at least one electrode positionable adjacent the nerve (see [0294]; the implantable device 2010can be placed in a variety of places including the tibial nerve, the vagal nerve, the occipital nerve, and more, [0309]; lead 4220 is positioned in a desired location to deliver the electrical pulses to the nerve and thereby mask pain signals from the nerve (see [0223]; applying electrical modulation at high frequencies can block transmissions, and this modulation can be very effective in managing certain types of pain).
Regarding claim 2, Yakovlev teaches the nerve stimulation device of claim 1, wherein at least one of said first flexible substrate and said second flexible substrate is constructed of a polymer material (see [0344]; implantable device 4110 may be encapsulated and packaged in a silicone elastomer, [0346]; implantable device 4110 can be fully integrated into a lead 4220 with electrodes 4230, lead 4220 can be made of a variety of biocompatible materials including a variety of polymers).
Regarding claim 3, Yakovlev teaches the nerve stimulation device of claim 1, wherein at least one of said first flexible substrate and said second flexible substrate is constructed of a protein- based material (see [0221]; electrodes can further be coated with drug eluting agents which may include collagen).
Regarding claim 4, Yakovlev teaches the nerve stimulation device of claim 1, wherein the wearable energy transmitter patch defines a contact surface, and wherein the contact surface is provided with a skin-compatible adhesive (see [0039]; the at least one external patch device further comprises an adhesive layer, [0298]; the enclosure of external device 4100 can be attached directly to the skin through an adhesive).
Regarding claim 5, Yakovlev teaches the nerve stimulation device of claim 1, wherein said energy transmitter antenna and said energy receiver antenna are configured as RF antennas (see [0297]; external device 4100 can include one or more antennas 4150 for transmitting and receiving RF signals, [0342]; implantable device 4100 comprising housing 4200 and antenna(s) 4240 wherein antenna 4240 normally supplies RF signals).
Regarding claim 6, Yakovlev teaches the nerve stimulation device of claim 1, wherein said energy transmitter antenna and said energy receiver antenna are configured as inductive coils (see [0252]; external device 2030 may transfer power to the implantable device 2010, powering may be accomplished with electromagnetic power transfer in which electric and/or magnetic fields are altered and the energy in these changing fields is captured through receivers, e.g. inductive coils, on the implant).
Regarding claim 7, Yakovlev teaches the nerve stimulation device of claim 1, wherein said energy transmitter antenna is configured to provide an operating voltage to said energy receiver antenna via inductive coupling (see [0287]; the battery 2510 can be recharged wirelessly using inductive coupling).
Regarding claim 8, Yakovlev teaches the nerve stimulation device of claim 1, wherein said pulse generator circuitry is configured to generate electrical pulses operative to mask pain signals from a nerve in the form of a pulse train of tonic pulses having at least one of a pulse width of about 100 us and a pulse frequency of about 400Hz, and an amplitude in the range of about 320 mV to 3.7 V (see [0075]; electrical stimulation can be configured to have the following parameters: frequency in the range between 1 Hz and 50kHz, pulse width in the range between 10 and 500 microseconds).
Regarding claim 10, Yakovlev teaches the nerve stimulation device of claim 1, wherein said at least one electrode comprises one of a microelectrode (see [0312]; device 4110 can incorporate microelectrodes, each microelectrode can be independently controlled and a set of microelectrodes can be coordinated) and a microelectrode array (MEA) provided with an electrochemically active coating operable to increase charge delivery via said at least one electrode (see [0065]; the at least one electrode can comprise a coating which may comprise platinum, iridium, gold, alloys, carbon nanotubes, or combinations thereof, the electrode can comprise a microelectrode).
Regarding claim 11, Yakovlev teaches the nerve stimulation device of claim 1, wherein said at least one electrode comprises one of a microelectrode (see [0312]; device 4110 can incorporate microelectrodes, each microelectrode can be independently controlled and a set of microelectrodes can be coordinated) and a microelectrode array (MEA) provided with one of a bactericidal coating and a bactericidal element (see [0065]; the at least one electrode can comprise a coating which may comprise platinum, iridium, gold, alloys, carbon nanotubes, or combinations thereof, the electrode can comprise a microelectrode).
Regarding claim 15, Yakovlev teaches the nerve stimulation device of claim 1, wherein said bactericidal element is selected from a group consisting of zinc, silver, gold, platinum and copper (see [0065]; the at least one electrode can comprise a coating which may comprise platinum, iridium, gold, alloys, carbon nanotubes, or combinations thereof).
Regarding claim 35, Yakovlev teaches a nerve stimulation device (2000 or 4100) comprising:
a flexible substrate (see [0039]; the at least one external device or patch comprises a flexible substrate configured to attach the at least on external device to the patient, [0248]; external device 2030 can take a form factor of a self-adhesive patch implemented on a flexible substrate 2610),
transmitter circuitry electrically coupled to a power source (see [0248]; flexible substrate 2610 can include a battery and other circuitry 2630, [0298]; the enclosure of external device 4100 surrounds a power supple 4130) and supported on said flexible substrate (see Fig. 22, [0236-0238], [0245]; transmission antenna 2210, transceiver 2270, Bluetooth or other standard communication protocol 2220, Fig. 37, [0299]; antennas 4150 each attached to relay or communication electronics 4160);
said transmitter circuitry defining an energy transmitter antenna (2210 or 4150) configured to transmit a signal wirelessly (see [0238]; for wireless powering and communication using electromagnetic energy the external device 2030 uses one or more antennas 2210, [0296]; external device 4100 can transfer both power and data to the implantable device 4110); and
pulse generator circuitry (2180 or [0296]; implantable device 4110 can include a pulse generator) operatively connected (Figs. 21 and 38) to receive a power signal [0304]; antennas of the external device can be configured to operate implanted devices including transmitting power and/or communication to the implanted devices) and generate electrical pulses operative to mask pain signals from a nerve (see [0017-0019]; embodiments of the invention provide for precise, controlled modulation of specific nerves or tissues to induce physiological effects for therapies, the conditions to be treated include chronic and acute pain),
an implantable energy receiver antenna (2110 or 4240) configured to receive the signal transmitted from said energy transmitter antenna (see [0236]; external device 2030 may include a transmission antenna 2210 that can be placed near the surface of the skin in close proximity to the antenna 2110 of the implantable device 2010, this link can transfer both power and data to the implantable device 2010), and
an implantable lead (2170 or 4220) electrically coupled to said pulse generator circuitry to receive said electrical pulses (see Fig. 21; electrode or lead interface 2170 coupled to pulse generator 2180, [0307]; implantable device 4110 comprising one or more electrodes 4230, which may be part of lead 4220 and pulse generator circuitry); and
comprising at least one electrode positionable adjacent the nerve (see [0294]; the implantable device 2010can be placed in a variety of places including the tibial nerve, the vagal nerve, the occipital nerve, and more, [0309]; lead 4220 is positioned in a desired location) to deliver the electrical pulses to the nerve and thereby mask pain signals from the nerve (see [0223]; applying electrical modulation at high frequencies can block transmissions, and this modulation can be very effective in managing certain types of pain).
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Yakovlev et al (US 20200101291 A1) in view of Miller et al (US 20020116034 A1).
Regarding claim 9, Yakovlev teaches the nerve stimulation device of claim 1. Yakovlev is silent regarding wherein said pulse generator circuitry is configured to supply tonic pulses to a load variable resistor having a resistance variable from about 1k Ohm to about 25 Ohm, to provide an associated output power of up to about 180 mW.
Miller teaches a stimulation device in the form of a pacemaker comprising pulse generator circuitry (30), which uses pulse generator circuitry to convert a power signal from one form of energy to another in order to delivered a desired therapeutic signal to a user (Miller [0032]),
wherein said pulse generator circuitry (30) is configured to supply tonic pulses (see Miller [0013]; electrically powered pulsing circuitry distributed between a pulse generator oscillator and a pulse generator power amplifier where power is continuously delivered and converted) to a load variable resistor (71a and 71b) to provide an associated output power of up to about 180 mW (see Miller [0052]; the values of the components which make up amplifier circuit 72 are selected to produce a total pacing power level of about 10 mW).
Miller is silent regarding the load variable resistor having a resistance variable from about 1k Ohm to about 25 Ohm. However, it can be appreciated that Miller does teach pulse generator circuitry having a variable resistor (Miller [0051]) wherein the values of the components of amplifier circuit 72 (which is the same as pulse generator amplifier circuitry 30), are selected to produce a total pacing power output of about 10 mW. It can be appreciated that it has been found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II), In re Aller, 220 F.2d. The prior art of Miller discloses the general conditions of the prior art wherein in order to provide a desired output power, a variable resistor may be selected which allows the circuit to achieve the desired power.
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Yakovlev’s pulse generator circuitry with the pulse generator circuitry taught by Miller. One of ordinary skill in the art would have been motivated to make this modification in order to select components of the pulse generator circuitry which would allow for a desired output power to be achieved in a variety of scenarios (Miller [0051-0052]), while using a device which converts energy from one form to another (Miller [0032]).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Yakovlev et al (US 20200101291 A1) in view of Chao (US 20130256120 A1).
Regarding claim 12, Yakovlev teaches the nerve stimulation device of claim 11. Yakovlev is silent regarding wherein said the bactericidal coating comprises one of titanium nitride and zirconium nitride.
Chao teaches a method for forming an antibacterial coating on the surface of an object (Chao, Abstract), wherein the object may be a medical product (Chao [0036]), and the antibacterial coating comprises one of titanium nitride and zirconium nitride (see Chao [0013]; the object can be quickly coated with one of zirconium nitride, titanium nitride, or chromium nitride).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Yakovlev’s nerve stimulation device having a coating which may comprise an alloy or antimicrobial metal with Chao’s antibacterial coating. One of ordinary skill in the art would have been motivated to make this modification in order to increase the safety of implantation of the stimulation device by forming an even filmed and high-density bactericidal coating (Chao [0013]) using the same materials (alloy and/or antimicrobial metal) as Yakovlev’s electrode coating.
Regarding claim 13, Yakovlev teaches the nerve stimulation device of claim 11. Yakovlev is silent regarding wherein said bactericidal coating is constructed of a material sputtered to form pillars defining pores therebetween.
Chao teaches a method for forming an antibacterial coating characterized by the configuration of a cathode art target source and a magnetron sputtering target source forming fine pores (Chao [0013]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Yakovlev’s nerve stimulation device having a coating which may comprise an alloy or antimicrobial metal with Chao’s antibacterial coating formed using a sputtering technique. One of ordinary skill in the art would have been motivated to make this modification in order to increase the safety of implantation of the stimulation device by forming an even filmed and high-density bactericidal coating (Chao [0013]) using the same materials (alloy and/or antimicrobial metal) as Yakovlev’s electrode coating.
Regarding claim 14, Yakovlev and Chao teach the nerve stimulation device of claim 13. Yakovlev is silent regarding wherein said bactericidal coating further comprises an antibiotic material disposed in the pores.
Chao teaches wherein said bactericidal coating further comprises an antibiotic material disposed in the pores (see Chao Fig. 1, [0020-0030]; silver particles are disposed in pores between zirconium/titanium/chromium nitride particles to form a mixed antibacterial film).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Yakovlev’s nerve stimulation device having a coating which may comprise an alloy or antimicrobial metal with Chao’s mixed antibacterial coating formed using a sputtering technique. One of ordinary skill in the art would have been motivated to make this modification in order to increase the safety of implantation of the stimulation device by forming an even filmed and high-density bactericidal coating (Chao [0013]) using the same materials (alloy and/or antimicrobial metal) as Yakovlev’s electrode coating.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Yakovlev et al (US 20200101291 A1) in view of Barreras (US 5591217 A).
Regarding claim 16, Yakovlev teaches the nerve stimulation device of claim 1. They are silent regarding wherein said implantable receiver comprises a full bridge rectifier for converting received alternating voltage to DC voltage.
Barreras teaches an implantable stimulation device (10) which is wirelessly charged via an external RF transmitted and surgically implanted receiver (Barreras [Col 1, lines 48-60]),
wherein said implantable receiver (10) comprises a full bridge rectifier (18) for converting received alternating voltage to DC voltage (see Barreras [Col 6, lines 55-60]; the RF coupled power, which is AC in nature, is converted by the full bridge rectifier circuit 18 into a high DC voltage).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Yakovlev’s nerve stimulation device with the full bridge rectifier as taught by Barreras. One of ordinary skill in the art would have been motivated to make this modification in order to convert the AC energy signal received from the RF coupled external power source/transmitter circuitry into a DC voltage which may be used to provide nerve stimulation via implanted electrodes.
Regarding claim 17, Yakovlev and Barreras teach the nerve stimulation device of claim 16. Yakovlev is silent regarding wherein said implantable receiver further comprises a voltage regulator operable to regulate DC voltage.
Barreras teaches wherein said implantable receiver (10) further comprises a voltage regulator (32) operable to regulate DC voltage (see Barreras [Col 6, lines 55-61]; voltage regulator 32 converts the high DC voltage into a lower precise DC voltage).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Yakovlev’s nerve stimulation device with the voltage regulator as taught by Barreras. One of ordinary skill in the art would have been motivated to make this modification in order to convert the DC voltage which may be used to provide nerve stimulation via implanted electrodes from a high DC voltage into a lower, precise DC voltage which may be used to safely deliver nerve stimulation via implanted electrodes.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Campbell et al (US 20140200626 A1) teaches an implantable transient nerve stimulation device.
Mishra et al (US 20190151659 A1) teaches methods and systems for treating pelvic disorders and pain conditions using an implantable lead and an external power device.
Holinski et al (US 20200078596 A1) teaches a garment for positioning a midfield transmitter relative to an implanted transmitter.
Yang et al (US 20090047413 A1) which teaches a conductive therapeutic coating for a medical service comprising a conductive carrier and a therapeutic agent.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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