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 . Claims 1-2, 4, 6-8, 11-16, 19-22, 26-27, 29, and 32 are currently pending with claim 32 being withdrawn (see below).
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-2, 4, 6-8, 11-16, 19-22, 26-27, 29, drawn to a flexible electrode.
Group II, claim 32, drawn to a method of manufacturing a flexible electrode.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Group I and II lack unity of invention because even though the inventions of these groups require the technical feature of a flexible electrode including a fixing portion, an implantable portion with their associated detail, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Xiang (see rejection below). Xiang teaches all of the elements of claim 1 including the special technical feature which is present in both claims 1 and 32.
During a telephone conversation with Lennie Bersh on 01/08/2026 a provisional election was made with traverse to prosecute the invention of Group I, claims 1-2, 4, 6-8, 11-16, 19-22, 26-27, 29. Affirmation of this election must be made by applicant in replying to this Office action. Claim 32 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Claims 1, 4, 6-7, 11-16, 21-22, 26-27, 29, and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xiang et al. US Publication 2016/0331326
(hereinafter Xiang).
Regarding claim 1, Xiang discloses a linear flexible electrode for a peripheral nerve (abstract, Figures 1-5C), the flexible electrode comprising an implantation portion and a fixing portion (Figure 4B with the implantation portion being closer to the electrodes at 120, and the fixing portion being closer to the pad side at 112a-b), wherein at least part of the implantation portion is implantable into a peripheral nerve bundle ([0013] which include microneedles as an extension of the electrodes), and the fixing portion is configured to fix the flexible electrode to the peripheral nerve bundle or other tissues in the a vicinity of the peripheral nerve bundle (portions where 130 is located in the middle of the device in Figure 4B), wherein: the flexible electrode comprises a first insulation layer ([0056][0071] which details two layers of polymer insulation), a second insulation layer and a wire layer between the first insulation layer and the second insulation layer ([0056][0071]); and the implantation portion comprises one or more electrode sites (electrodes 120 within Figures 4A-B), each electrode site is electrically coupled to one of the wires in the wire layer (Figures 4A-B at electrodes 120 which shows being connected to the wires/traces), and in contact with the peripheral nerve after the flexible electrode is implanted into the peripheral nerve bundle to collect electrical signals from the peripheral nerve and transmit the collected electrical signals through the wires (abstract, [0003]-[0015][0071]), or apply received electrical signals through the wires to the peripheral nerve ([0007]-[0010]), wherein the fixing portion comprises a pore in the flexible electrode (130), and a fixing device is capable of passing through the pore and being attached to the peripheral nerve bundle or the other tissues to fix the flexible electrode to the peripheral nerve bundle or the other tissues (sutures are mentioned as per [0009][0010][0044][0046]).
Regarding claim 4, Xiang discloses that the other tissues comprise muscles or bones in the vicinity of the peripheral nerve bundle (the suture holes 130 are fully capable of being attached to other tissue such as muscle or bones in the vicinity of the peripheral nerve given as the structure remains unchanged). The “or” statement renders the rest of the limitations of claim 4 optional.
Regarding claim 6, Xiang discloses that the electrode sites are located on an outer side of at least one layer of the first insulation layer and the second insulation layer (0056]), and electrically coupled to the wires in the wire layer through a via hole in the at least one layer (though a via is not explicitly disclosed it would be required in order for the trace to contact the electrode site 120 and function as intended).
Regarding claim 7, Xiang discloses that the electrode sites comprise a conductive sub-layer, and a material of the conductive sub-layer is any of gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, titanium alloy, graphite, carbon nanotubes and PEDOT or a combination thereof (gold and platinum are mentioned in some order as the electrode site as per [0056]).
Regarding claim 11, Xiang discloses a back end portion implanted hypodermically and fixed by the fixing portion (back end being the end closer to the pads at 112A-B in Figure 4B; the implantation method is a product by process type limitation and given the devices are of a comparable sizing and utilized in the same locations it would have been reasonable to assume the device would have been fully capable of being implanted as claimed), wherein: the back end portion comprises a back end site (pads at 112a-b) coupled to both one of the wires in the wire layer and a back end circuit ([0047] which details connecting to various circuits as is known in the art) to realize bidirectional signal transmission between the electrode sites electrically coupled to one of the wires and the back end circuit ([0047] details that the circuitry can provide stimulation and/or amplifier for sensing which would afford the bidirectional transmission).
Regarding claim 12, Xiang discloses that the flexible electrode comprises a pair of fixing portions located on both sides of the back end portion (Figure 4B there are 6 fixing portions near 130on the end further from the electrodes 120).
Regarding claim 13, Xiang discloses that the flexible electrode further comprises a pair of fixing portions located on both sides of a connection portion of the flexible electrode (same portion of the device as mentioned above at elements 130 of Figure 4B), wherein the connection portion is a part of the flexible electrode located between the implantation portion and the back end portion (Figure 4B at pads 112A-B, where portion is incredibly broad and the back portion includes the entire back half which inherently would force the connection portion to be between one end of the back portion and the implantation portion).
Regarding claim 14, Xiang discloses that the back end site is located in the wire layer and exposed through a via hole in at least one layer of the first insulation layer and the second insulation layer (back end sites at 112A-B), though whether the pads are on top of the insulator and connected to the trace through a conductive via or is just an exposed portion of the trace are incredibly well-known art recognized equivalents of each other and would have produced predictable results of connecting the electrodes to circuitry.
Regarding claim 15, Xiang discloses that the back end site is located between the wire layer and at least one layer of the first insulation layer and the second insulation layer ([0047] which details the back end site can be interior or exterior to the polymeric insulation), and exposed through a via hole in the other layer of the first insulation layer and the second insulation layer (if interior it would have to be exposed with a via, see [00047]).
Regarding claim 16, Xiang discloses that the back end site comprise a conductive sub-layer, and a material of the conductive sub-layer is any of gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, titanium alloy, graphite, carbon nanotubes and PEDOT or a combination thereof (gold and titanium are listed as per [0056] which details these materials can be utilized for the electrodes, traces, and/or the back end sites; as these materials include titanium it is also a known adhesion layer for other metals such as gold).
Regarding claims 21-22, Xiang discloses that the wire layer comprises a conductive sub-layer, and a material of the conductive sub-layer is any of gold, platinum, iridium, tungsten, platinum-iridium alloy, titanium alloy, graphite, carbon nanotubes and PEDOT or a combination thereof ([0056] which details traces can be made of gold and/or titanium) which can include a thickness of 5nm to 200mcrons ([0057] which details 320nm).
Regarding claims 26-27, the flexible separation layer and its associated specifics are considered a product by process type limitation where they are not in the final product of the device (part that is implanted), and as the flexible electrode is the apparatus being claimed, the intermediate steps are given minimal patentably distinguishable weight as they are not in the final product (see MPEP 2113).
Regarding claim 29, Xiang discloses that the implantation portion comprises a mounting hole through which the electrode implantation device is attached to the flexible electrode for implantation (the holes are already claimed at 130, as per Figure 4B and the holes are fully capable of being utilized for implantation as structurally there is no difference between them).
Claim Rejections - 35 USC § 103
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 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Xiang in view of Xie et al. US Publication 2020/0261025 (hereinafter Xie).
Regarding claim 2, Xiang is silent on the use of multiple layers including additional insulation and wire layers. Xie teaches an electrode sensing device that includes a flexible electrode with a plurality of wire layers spaced apart by an additional insulation layer, and each wire layer comprises a plurality of wires spaced apart from each other ([0052]-[0053] which details the use of additional alternating layers of wire and insulation to accommodate additional electrodes). Therefore it would have been obvious to the skilled artisan before the effective filing date to utilize the additional layers of wire/insulation as taught by Xie with the electrode of Xiang in order to allow for more electrodes without creating a dramatically larger cross-sectional area.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Xiang in view of Judy et al. US Publication 2018/0338765 (hereinafter Judy).
Regarding claim 8, Xiang is silent on the adhesion layer though some combination of gold and titanium were mentioned ([0056] where titanium is a known adhesion layer for coupling gold to other metals). Judy teaches a nerve sensing device that includes electrode sites with an adhesion sub-layer close to the wire layer ([0070][0072] which details the use of platinum traces that can be combined with electrode sites of gold/titanium in alternating layers, where titanium is a known adhesive layer), and the adhesion sub-layer is made of a material capable of enhancing the adhesion between the electrode site and the wire layer ([0072] where titanium is mentioned). Therefore it would have been obvious to the skilled artisan before the effective filing date to utilize the adhesion material as taught by Judy with the electrode site of Xiang as the materials are art recognized equivalents of each other and would have produced predictable results of electrically connecting the electrodes to the required circuitry.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Xiang in view of Martens et al. US Publication 2021/0387001 (hereinafter Martens).
Regarding claims 19-20, Xiang teaches the flexible circuit and back end circuit as mentioned above but is silent on the additional encapsulation. Martens teaches a neural implantable medical device that includes a flexible electrode ([0135]) with a back end circuit connected to the back end portion that is encapsulated together by any of epoxy resin and polydimethylsiloxane or a combination thereof with a further coating of a biocompatible adhesive after encapsulation (layer 1300, as well as [0276] which details encapsulating the device in PDMS and silicone which is a biocompatible adhesive in either order). It would have been obvious to the skilled artisan before the effective filing date to utilize the encapsulation layers as taught by Martens with the device of Xiang in order to ensure the circuitry on the back end is sealed from the surrounding tissue preventing damage.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian M Antiskay whose telephone number is (571)270-5179. The examiner can normally be reached M-F 10am-6pm EST.
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/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794