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 .
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(s) 1-13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Xu(WO 2017181027 A1) in view of JP 2009509691 A. Reference JP 2009509691 A hereinafter known as Ref B.
Regarding claim 1, Xu discloses a self-applied wearable device configured to electrically stimulate a user, generate and/or collect the user electrophysiological data(A promising alternative are stretchable/flexible electronics that can achieve intimate, conformal integration with tissues and organs with minimal mobility confinement and user discomfort. With robust, intimate and low impedance contact, soft devices can eliminate the ever-changing parasitic capacitance at the electrode-body interface, and thus ensure highly sensitive and accurate measurement of electrophysiological signals[0005]), comprising one or more (A closed-loop wearable device or platform integrates sensors, actuators, and microcontroller on board. The device is applied directly to the skin using stretchable epidermal electronics. It can sense a variety of signals from the human body, thus collecting medically relevant information, and can activate delivery of a therapeutic upon detection of an abnormal condition[abstract]) and/or a combination thereof to move biological ions and/or polar molecules from beneath the skin surface into the outer skin surface to increase conductivity and/or to move the molecules from the one or more electrodes into the outer skin layer of skin surface to reduced impedance between the outer skin layer and electrode, wherein the impedance between the one or more electrodes is matched and/or minimized when the device is worn by the user and the one or more electrodes are in contact with the outer layer of a skin surface(In some embodiments the drug delivery chamber may be used to deliver a drug in accordance with iontophoresis. In an iontophoresis process, a charged substance such as a drug or other agent is driven by a repulsive electromotive force through the skin. A small electric current is applied to the chamber that contains the charged drug and its solvent when the wearable device is placed on the skin. Another electrode carries the return current. The positively charged electrode repels the positively charged chemical species and the negatively charged electrode repels a negatively charged species, driving it into the skin[00065]). Xu fails to disclose configured to hydrate an outer layer of the skin via iontophoresis, reverse iontophoresis.
However, Ref B teaches the hydrogel hydrates the skin and thus protects against inflammation due to electrical stimulation by the hydrogel, while swelling the skin and allowing more efficient transfer of the active component(see translated copy provided, page 15, paragraph 4).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the closed loop wearable device with the hydrogel of the iontophoresis device of Ref B. Doing so would allow for hydration of the skin around the worn electrode to occur to prevent irritation for the user.
Regarding claim 2, Xu in view of Ref B teaches the device of claim 1, wherein the one or more electrodes use iontophoresis or reverse iontophoresis(Xu - In some embodiments the drug delivery chamber may be used to deliver a drug in accordance with iontophoresis. In an iontophoresis process, a charged substance such as a drug or other agent is driven by a repulsive electromotive force through the skin. A small electric current is applied to the chamber that contains the charged drug and its solvent when the wearable device is placed on the skin. Another electrode carries the return current. The positively charged electrode repels the positively charged chemical species and the negatively charged electrode repels a negatively charged species, driving it into the skin[00065]).
Regarding claim 3, Xu in view of Ref B teaches the device of claim 1, but Xu fails to disclose in which the one or more electrodes use iontophoresis and reverse iontophoresis in combination. However, Ref B teaches As a result, the terminals or poles 16a, 16b of the power supply 16 can be reversed. Similarly, the selectivity of the outermost ion selective membranes 38, 80 and the inner ion selective membranes 30, 74 can be reversed. The iontophoresis device 10 further includes an inert molding material 86 adjacent to the exposed surfaces of various other structures that form the working electrode structure 12 and the counter electrode structure 14(See translated copy provided, page 12, paragraphs 7 and 8).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the closed loop wearable device with the reverse aspect of the iontophoresis device of Ref B. Doing so would allow for the user to perform both iontophoresis and reverse iontophoresis with the device to insert and extract ions or substances of the skin based on the needs of the user.
Regarding claim 4, Xu in view of Ref B teaches the device of claim 1, that measures impedance and actively optimizes impedance by iontophoresis, reverse iontophoresis, and/or combination thereof using an optimization algorithm running on a microprocessor of the device or on a computer through a wired or wireless communications path(Xu - Furthermore, when equipped with wireless data transfer components, the system can be integrated with body-area-networks (BAN) to communicate with an externally functionally expansive central processing unit worn or placed on/in the human body to achieve all-around multi-position health monitoring and treatment. FIG. 13 illustrates a more detailed example of the control system shown in FIG. 1. The control system 500 includes a microcontroller 510, a potentiostat 520, a current source 520, a power source 530, a power regulator 540, a multiplexer 560 and contacts 570 for communicating with the sensor module and the actuator module. FIG. 14 shows a high level functional block diagram of the overall control process which includes sensors 580, sensor readout circuitry 582 that receives signals from the sensors 580, which in turn are provided to a microprocessor 584. Microprocessor 584 will analyze the sensors data, make a decision and 586 for drug delivery or drug hold. The rightmost portion of the figure shows the current source 586 signal when the drug delivery chamber is to be in its active state delivering a drug or other agent and when it is to be in its passive state to prevent or minimize drug delivery[0082]).
Regarding claim 5, Xu in view of Ref B teaches the device of claim 1, but Xu fails to disclose comprising one or more electrodes having the ability to absorb biological ions and/or polar molecules and/or release biological ions and/or polar molecules, wherein the one or more electrodes is electrically connected to electronics.
However, Ref B teaches According to one embodiment, an iontophoresis device operable to deliver an active substance to a biological interface of a living body, when in use, is external to the active electrode that should be proximal to the biological interface. An exposed contact surface; a working electrode element operable to apply a first potential; a first active substance reservoir capable of storing a first active substance; and a second active substance. And at least one second active substance reservoir, and an outermost ion selective membrane (first active substance and second active substance) exposed to the outside of the iontophoresis device for forming the biological interface. Is substantially permeable by ions having a first polarity consistent with the polarity of the first and is substantially impermeable by ions having a second polarity opposite to the first polarity, Active substance reservoir and second active substance reservoir Is formed in the outermost ion selective membrane, and the second active substance reservoir is disposed laterally at a distance on a plane substantially parallel to the contact surface from the first active substance reservoir, At least a first active substance reservoir and at least some of the first active substance and the second active substance, respectively, actively transferred from the iontophoresis device to the biological interface in response to the application of the first potential; A second active agent reservoir is disposed with respect to the working electrode element), and a counter electrode element operable to apply a second electric potential, It includes a counter electrode structure laterally spaced from a working electrode structure having a potential different from the first potential(see attached translated copy, page 3, “Tech-Solution”, paragraph 1).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the closed loop wearable device with the biological ions of the iontophoresis device of Ref B. Doing so would allow ions and polar molecules to permeate the skin during the process of iontophoresis so the user is able to obtain the substances required.
Regarding claim 6, Xu in view of Ref B teaches the device of claim 5, but Xu fails to disclose wherein the electronics are untethered, battery- operated, energy harvesting, or wired for power, wired communications or wireless communication. However, Ref B teaches An iontophoresis device typically includes a working electrode structure and a counter electrode structure that are each connected to a power source, such as a chemical battery or an opposite pole or terminal of an external power source(see attached translated copy, page 2, “Background Art”, paragraph 2).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the closed loop wearable device of Xu with the battery of Ref B. Doing so would allow for a power source to be connected to the electrode system to supply a current throughout stimulation.
Regarding claim 7, Xu in view of Ref B teaches the device of claim 1 comprising one or more impedance measuring circuits and/or source/sink electrical current generators, wherein said device has the ability to measure electrophysiological data, optionally selected from the group consisting of electroencephalogram (EEG), electrooculography (EOG), electrocardiogram (ECG), electroatriography (EAG), electroventriculography (EVG), intracardiac electrogram (EGM), electrocorticography (ECoG or iEEG), electromyography (EMG), electroretinography (ERG), electronystagmography (ENG), electroolfactography (EOG), electrocochleography (ECOG or ECochG), electrogastrography (EGG), electrogastroenterography (EGEG), and electromyography (EMG)(Xu - For EOG, the amplifier settings can be identical except that an electrode on the individual's left forearm may act as a ground for the commercial system. Offline, data can be filtered with a band-pass from 0.1 and 30 Hz to remove high frequency muscle activity and low- frequency drifts. The mean voltage of each signal may be subtracted to remove DC offset differences. The data may then be normalized to remove the influence of electrode impedance differences between the commercial and flexible systems[000129]).
Regarding claim 8, Xu in view of Ref B teaches the device of claim 1, but fail to teach wherein the device is operated by an algorithm that rotates electrodes in use and changes polarity of the electrodes to provide impedance conditioning thereby minimizing oxidation of the electrodes. However, the recitation “that is operated by an algorithm that rotates electrode in use and changes polarity of the electrodes to provide impedance conditioning thereby minimizing oxidation of the electrodes” fails to further define the claimed invention over the prior art because it merely recites the intended use of the device rather than further limiting any patentable aspect of the device.
Regarding claim 9, Xu in view of Ref B teaches the device of claim 1 wherein the device is integrated into a headband, earpiece, arm band, leg band, wrist band, ring, nosepiece, chest patch or wearable sensor net or patch(Xu - Disclosed are materials, devices, systems and methods that pertain to a closed- loop wearable platform that integrates sensors, actuators, and microcontroller on board. The system may be applied directly to the skin using stretchable epidermal electronics[00029]).
Regarding claim 10, Xu in view of Ref B teaches the device of claim 1, wherein the one or more electrodes are configured to provide an electrical stimulation selected from transcranial direct current stimulation (tDCS) or electrical muscle stimulation (EMS)(Xu - The high-frequency electromyogram (EMG) activity from the forearm can be acquired, again to compare the commercial and wearable systems. Abi-polar EMG electrode pair can be placed on the proximal left forearm over the flexor carpi radialis muscle. For commercial recording a pair of Ag/AgCl ring electrodes can be used, fixed with an adhesive sticker to the skin along with conductive electrode paste, with a nearby ground. Directly parallel with these the wearable system and electrodes are placed such that the distance between the electrodes and the angle with respect to the muscle is the same[000121]).
Regarding claim 11, Xu in view of Ref B teaches the device of claim 1, wherein the one or more electrodes comprise a flexible biocompatible conductive polymer(Xu - When producing an implantable electronic device biocompatibility should be taken into account. Once implanted into the body, a fibrous, collagen-based membrane can develop around the device. An implanted device should have a package that is biocompatible. The surface properties of the polymer film may be selectively tuned by the incorporation of functionalized elements to meet specific requirements. The coated polymer may be biocompatible with the surrounding cells so as not to induce any toxic side effects. EM Decoupling From Human Body Absorption[000111]).
Regarding claim 12, Xu in view of Ref B teaches the device of claim 1, but Xu fails to disclose wherein the one or more electrodes comprise a hydrogel or a silicone polymer, optionally a polydimethylsiloxane (PDMS) polymer. However, Ref B teaches in some embodiments, the gel matrix can include hydrogels, organogels, and the like. Hydrogel refers to a three-dimensional network of cross-linked hydrophilic polymers composed substantially of water, for example in the form of a gel. The hydrogel may have a net positive charge, a negative charge, or may be neutral(see attached translated copy, page 5, paragraph 4).
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the closed loop wearable device with the hydrogel of the iontophoresis device of Ref B. Doing so would allow for hydration of the skin around the worn electrode to occur to prevent irritation for the user.
Regarding claim 13, Xu in view of Ref B teaches the device of claim 11, wherein the electrodes further comprise conductive particles selected from silver particles, silver threads, carbon particles, carbon nanotubes, graphene, Ag/AgCl and Ag/AgAl(Xu - For EEG, a pair of EEG electrodes may be affixed to the forehead. A pair of Ag/AgCl electrodes are placed along the hairline, with the electrode at roughly position Fpz in the center referenced to the lateral electrode at location AF8[000123]).
Regarding claim 15, Xu in view of Ref B teaches the device of claim 1, but fails to teach wherein the device is controlled by an impedance optimization algorithm. However, the recitation “the device is controlled by an impedance optimization algorithm” fails to further define the claimed invention over that of the prior art because it merely recites the intended use of the device rather that further limiting any patentable aspect of the device.
Regarding claim 16, Xu in view of Ref B a method for using a device of claim 1, wherein the user wears the device; the device electrically stimulates the user and collects electrophysical data from the user(Systems and methods according to present principles focus on integrating electrophysiological sensors, drug releasing components, and a controller on an epidermal platform[00010]. Therefore, additional strategies are needed to keep the wearable platform in contact with the skin when it is to be worn over a long term to e.g., continuously monitor electrophysiological signals on the skin[000103]).
Response to Arguments
Applicant’s arguments, see remarks, filed 9/22/2025, with respect to the 35 U.S.C. 101 rejection have been fully considered and are persuasive due to the amendments. However, the arguments regarding the 35 U.S.C. 103 rejections have been fully considered but they are not persuasive. Regarding the 103 rejections, applicant argues that Xu in view of Ref B fails to disclose “an iontophoresis device”. Ref B teaches “The iontophoresis device includes a working electrode structure and a counter electrode structure”(see attached translation, abstract). Ref B teaches an iontophoresis device with electrodes for delivering current to cause hydration, and therefore teaches an iontophoresis device, (see translated copy provided, page 15, paragraph 4). Therefore the combination of Xu and Ref B teaches the disclosed material and the 103 rejection for all claims stands.
Conclusion
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796