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/Restriction
Applicant's election with traverse of Group I (claims 1-6, 8-13, 16-19, 27) in the reply filed on 5/26/2026 is acknowledged. The traversal is on the grounds that “the claims to different categories of invention are drawn to the following combinations of categories: a product and a process specially adapted for the manufacture of said product”. This is not found persuasive because the shared technical feature of: a flexible electrode for acupuncture comprising a first insulating layer, a second insulating layer, a wire layer and an electrode site, is not a special technical feature in view of the prior art of Malaney as described in the restriction requirement dated 3/26/2026.
The requirement is still deemed proper and is therefore made FINAL.
Claim 28 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 6, 10-12, 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20180008821 Gonzalez et al. (hereinafter Gonzalez).
Regarding claim 1, Gonzalez discloses a flexible electrode (80, Fig. 1) (200, Fig. 8) for acupuncture (Fig. 2-7, flexible electrode is inserted via acupuncture), an implanted portion (202, Fig. 8) of the flexible electrode (80/200) being able to be implanted into an acupoint for a long or short term (paragraph 42, 68-71 discloses stimulation and the flexible electrode being implanted into an acupoint, the limitation of being implanted into an acupoint for a long or short term is merely intended use and the device of the prior art is capable of performing this intended use), wherein:
the flexible electrode (80/200) comprises a first insulating layer (212, Fig. 8, paragraph 75), a second insulating layer (220, Fig. 8, paragraph 76), and a wire layer (layer of conductive traces 216) located between the first insulating layer (212) and the second insulating layer (220; as seen in Fig. 8);
the implanted portion (202, Fig. 8, 10) comprises a plurality of electrode sites (paragraph 77, Fig. 8, 10, vias 214 of insulating layer 212 defines electrode site with electrode array 208), each electrode site is electrically coupled to one of a plurality of wires in the wire layer (Fig. 8, 10, paragraph 76-77), and is in contact with the acupoint after implantation (as seen in Fig. 7, paragraph 71, 74-77); and
the plurality of wires are configured to respectively apply identical or different electrical stimulations to the acupoint through the plurality of electrode sites after implantation (paragraph 42, 46 discloses stimulation and a power source 90 to deliver electrical stimulations through the conductive traces 216).
Regarding claim 2, Gonzalez discloses the limitations of claim 1, and Gonzalez further discloses wherein the flexible electrode comprises a plurality of wire layers, the plurality of wire layers are separated from each other by an additional insulating layer, and each wire layer comprises a plurality of wires separated from each other (Fig. 28a-b, paragraph 101, “In another implementation, the insulating layer and the layer of conductive traces are part of a multiple-layer series of alternating insulating and conducting layers”, the ‘conducting layer’ corresponds to ‘a layer of conductive traces’ such that each conducting layer has multiple wires separated from each other).
Regarding claim 3, Gonzalez discloses the limitations of claim 1, and further discloses wherein the electrode site is located between the wire layer and at least one layer of the first insulating layer and the second insulating layer, and is exposed via a through-hole in the at least one layer (paragraph 77, Fig. 8, vias 214 of insulating layer 212 defines electrode site with electrode array 208 and filled with conductive material 218 to connect conductive traces 216 in wire layer with electrode array 208).
Regarding claim 6, Gonzalez discloses the limitations of claim 1, and further discloses wherein
the electrode site is located in the wire layer and exposed via a through-hole in at least one layer of the first insulating layer and the second insulating layer (paragraph 77, Fig. 8, vias 214 of insulating layer 212 defines electrode site with electrode array 208 and filled with conductive material 218 to connect conductive traces 216 in wire layer with electrode array 208); or
wherein a shape of the electrode site is provided as needed, a number of the electrode sites is 2 to 2000, a maximum side length or diameter of the electrode site is 1 micron to 2 millimeters, an interval from another electrode site of the electrode site is 10 microns to 10 millimeters, and a thickness of the electrode site is 5nm to 200µm.
Regarding claim 10, Gonzalez discloses the limitations of claim 1, and further discloses further comprising a rear end portion (204, Fig. 8), wherein
the implanted portion extends from the rear end portion (as seen in Fig. 8), and
the rear end portion comprises a rear end site (paragraph 77, Fig 8, vias 214 of insulating layer 212 defines rear end site with connection array 210) coupled to one of the wires in the wire layer and a rear end circuit, to achieve signal transmission between the electrode site electrically coupled to one of the wires and the rear end circuit (Fig. 8, paragraph 74, vias 214 connect wires 216 to connection array 210 to a rear end circuit (power source 90)).
Regarding claim 11, Gonzalez discloses the limitations of claim 10, and further discloses wherein the rear end site is located in the wire layer and is exposed via a through-hole in at least one layer of the first insulating layer and the second insulating layer (paragraph 77, Fig 8, vias 214 of insulating layer 212 defines rear end site with connection array 210 and filled with conductive material 218 to connect conductive traces 216 in wire layer with connection array 210).
Regarding claim 12, Gonzalez discloses the limitations of claim 10, and further discloses wherein the rear end site is located between the wire layer and one layer of the first insulating layer and the second insulating layer, and is exposed via a through-hole in another layer of the first insulating layer and the second insulating layer (paragraph 77, Fig 8, vias 214 of insulating layer 212 defines rear end site with connection array 210 and filled with conductive material 218 to connect conductive traces 216 in wire layer with connection array 210).
Regarding claim 19, Gonzalez discloses the limitations of claim 1, and further discloses wherein a cross-sectional area of the wire is 0.01 square micrometers to 1 square millimeter; or
wherein the first insulating layer and the second insulating layer have a thickness of 0.5 micrometers to 1 millimeter; or
wherein a material of the first insulating layer and the second insulating layer is any one of polyimide (paragraph 51, 56, insulator is made of polyimide), polydimethylsiloxane, parylene, epoxy resin, polyamide imide, SU-8 photoresist, silica gel, silicone rubber, or a combination thereof; or
wherein a material of the wire layer is any one of magnesium, molybdenum and an alloy thereof, or a combination thereof, and a material of the first insulating layer and the second insulating layer is any one of polylactic acid and polylactic acid - glycolic acid copolymer, or a combination thereof, so that the flexible electrode is biodegradable; or
wherein the electrical stimulation is a long-term electrical stimulation or a short-term electrical stimulation; or
wherein the identical or different electrical stimulations include currents or voltages with identical or different polarities; or
wherein the identical or different electrical stimulations include currents or voltages with identical or different amplitudes, wave widths, and frequencies; or
wherein the implanted portion has an installation hole through which an electrode implantation device is attached to the flexible electrode to perform implantation.
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.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez in view of US 20150151107 Schouenborg.
Regarding claim 8, Gonzalez discloses the limitations of claim 1.
Gonzalez is silent on wherein a contact surface of the electrode site for contacting a biological tissue has a surface modification layer for improving an electrochemical property of the electrode site.
In related prior art, Schouenborg teaches a device wherein an electrode site has a surface modification layer to improve the electrochemical properties of the electrode site (paragraph 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gonzalez with the teachings of Schouenborg in order to increase the electrically conducting surface area of the electrodes (paragraph 5).
Regarding claim 9, the combination of Gonzalez and Schouenborg teaches the limitations of claim 8, and Schouenborg teaches wherein any one or more of a conductive polymer and conductive metal particles are used for surface modification, the conductive polymer comprises poly (ethylenedioxythiophene) (paragraph 5, PEDOT is used to roughen surface of electrode), poly (p-styrenesulfonic acid), polypyrrole, and a material of the conductive metal particles comprises iridium, iridium oxide, platinum, and platinum iridium alloy.
Claims 4-5, 13, 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez in view of US 20110077660 Janik et al. (hereinafter Janik).
Regarding claim 4, Gonzalez discloses the limitations of claim 3.
Gonzalez is silent on wherein the electrode site comprises a conductive sub-layer, and a material of the conductive sub-layer is any one of gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, titanium alloy, graphite, carbon nanotubes, PEDOT, or a combination thereof.
In related prior art, Janik teaches a similar electrode device having multiple layers (Fig. 3, paragraph 81) that uses a conductive sub-layer (66) made of gold (paragraph 81) and an adhesive sub-layer (64/68) made of chromium to enhance adhesion between two surfaces (paragraph 81).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gonzalez with the teachings of Janik in order to incorporate the electrode site as multi-layered to enhance adhesion between two surfaces and having a conductive sub-layer made of gold in order to provide a low electrical resistance (paragraph 81).
Regarding claim 5, the combination of Gonzalez and Janik teaches the limitations of claim 4, and the combination teaches wherein the electrode site further comprises an adhesion sub-layer close to the wire layer, the adhesion sub-layer adopts a material capable of enhancing adhesion between the electrode site and the wire layer (paragraph 81, Janik teaches an outer adhesion sub-layer made of chromium to advantageously enhance adhesion between two surfaces; the modification of Gonzalez with Janik of claim 4 above would have the multi-layered electrode site further have an adhesion sub-layer made of chromium close to the wire layer in order yield a better adhesion surface for other materials (paragraph 81)).
Regarding claim 13, Gonzalez discloses the limitations of claim 12.
Gonzalez is silent on wherein the rear end site comprises a conductive sub-layer, and a material of the conductive sub-layer is any one of gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, titanium alloy, graphite, carbon nanotubes, PEDOT, or a combination thereof; or
wherein a thickness of the rear end site is 5 nanometers to 200 micrometers; or
wherein the rear end site further comprises an adhesion sub-layer close to the wire layer, and a material of the adhesion sub-layer is any one of chromium, tantalum, tantalum nitride, titanium, titanium nitride, or a combination thereof.
In related prior art, Janik teaches a similar electrode device having multiple layers (Fig. 3, paragraph 81) that uses a conductive sub-layer (66) made of gold (paragraph 81) and an adhesive sub-layer (64/68) made of chromium to enhance adhesion between two surfaces (paragraph 81).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gonzalez with the teachings of Janik in order to incorporate the rear end site as multi-layered to enhance adhesion between two surfaces and having a conductive sub-layer made of gold in order to provide a low electrical resistance (paragraph 81).
Regarding claim 16, Gonzalez discloses the limitations of claim 1.
Gonzalez is silent on wherein the wire layer comprises a conductive sub-layer, and a material of the conductive sub-layer is any one of gold, platinum, iridium, tungsten, platinum-iridium alloy, titanium alloy, graphite, carbon nanotubes, PEDOT, or a combination thereof.
In related prior art, Janik teaches a similar device wherein the wire layer (conductive trace 38, Fig. 3) is a metal film having multiple layers (Fig. 3, paragraph 81) including a conductive sub-layer (66) formed from gold (paragraph 81).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the single conductive trace taught by Gonzalez with the multiple layered conductive trace as taught by Janik since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; the multiple layered conductive trace of Janik wherein the conductive sub-layer is formed from gold would be sufficient to yield the predictable result of a conductive wire capable of transmitting electrical signals.
Regarding claim 17, the combination of Gonzalez and Janik teaches the limitations of claim 16, and Janik teaches wherein a thickness of the conductive sub-layer is 5 nanometers to 200 micrometers (paragraph 81, the conductive sub-layer 66 has a thickness of 5 microns or less, and in more preferred versions the conductive sub-layer has a thickness of approximately 2 microns, which falls within the claimed range).
Regarding claim 18, Gonzalez discloses the limitations of claim 10.
Gonzalez is silent on wherein the wire layer comprises a conductive sub-layer and an adhesion sub-layer close to any one of the electrode site and the rear end site, and a material of the adhesion sub-layer is any one of chromium, tantalum, tantalum nitride, titanium, titanium nitride, or a combination thereof.
In related prior art, Janik teaches a similar device wherein the wire layer (conductive trace 38, Fig. 3) is a metal film having multiple layers (Fig. 3, paragraph 81) including a conductive sub-layer (66) and an adhesion sub-layer (64/68) and a material of the adhesion sub-layer is any one of chromium, tantalum, tantalum nitride, titanium, titanium nitride, or a combination thereof (paragraph 81, bottom layer 64 and top layer 68 of conductive trace are formed from chromium for better adhesion to insulating layers).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the single conductive trace taught by Gonzalez with the multiple layered conductive trace as taught by Janik since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; the multiple layered conductive trace of Janik having a conductive sub-layer and an adhesive sub-layer (when combined with Gonzalez would have the conductive sub-layer and adhesive sub-layer close to either the electrode site or rear end site of Gonzalez) would be sufficient to yield the predictable result of a conductive wire capable of transmitting electrical signals, and the use of chrome in the adhesive sub-layer provides a better adhesive surface for other materials (paragraph 81).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez in view of CN114469117A Huang et al. (hereinafter Huang) and further in view of US 5211175 Gleason et al. (hereinafter Gleason).
Regarding claim 27, Gonzalez discloses the limitations of claim 10.
Gonzalez is silent on wherein after separating the flexible electrode from a substrate, the rear end portion is connected to the rear end circuit, and the rear end portion and the rear end circuit are packaged together by any one of epoxy resin and polydimethylsiloxane, or a combination thereof.
In related prior art, Huang teaches a similar electrode device having a substrate (auxiliary structure 4, Fig. 1) that is separable from a flexible electrode (2) (pg. 4 of machine translated document) and wherein the rear end portion (proximal portion of flexible electrode 2 that connects to the rear end circuit 1 as seen in Fig. 1) is connected to the rear end circuit (1) (as seen in Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gonzalez with the teachings of Huang in order to hold the flexible electrode in a fixed arrangement during implantation (pg. 4-6 of machine translation document).
Furthermore, in related prior art, Gleason teaches an electro-acupuncture system wherein a rear end portion (17, Fig. 1, 3) of an electrode (12’) is packaged together with a rear end circuit (13’) by an epoxy (Fig. 1-2, col. 4 line 17-20).
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 modification of Gonzalez with Huang with the teachings of Gleason in order to provide insulation and better securement of the electrode rear end portion and rear end circuit (col. 4 line 17-29).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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