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 Claims 1-2, 4, 6-8, 11-16, 19-22, 26-27, 29, and 32 are currently pending with claim 33 being previously withdrawn.
Election/Restrictions
Applicant’s election of Group I (claims 1-2, 4, 6-8, 11-16, 19-22, 26-27, 29) in the reply filed on 07/14/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4, 6-7, 11-16, 21-22, 26-27, 29, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Xiang et al. US Publication 2016/0331326
(hereinafter Xiang) in view of Rogers et al. US Publication 2019/0090801 (hereinafter Rogers).
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]).
Xiang is silent on the fixing portion being thicker than other parts of the flexible electrode to provide higher mechanical strength. Rogers teaches an implantable neural device that includes suture holes for anchoring the neural device (Figure 50) and teaches that the material around the suture holes should be thicker ([0383]) to avoid the substrate from ripping (before and after shown in Figure 50, see also 51A). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the thicker area around the fixing portion as taught by Rogers with the device of Xiang for the same predictable results above (prevent tearing of the substrate during anchoring).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Xiang in view of Rogers and in further 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 Rogers and in further 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 Rogers and in further 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.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 4 have been considered but are moot in view of the new ground(s) of rejection. The 102 is withdrawn in light of the Applicant’s amendments to the claims, new art has been applied above to remedy any deficiencies in the prior art of record. As the scope of the claims has changed, new art is able to be applied to claim 1 above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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