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 Claims 1-34 are currently pending, with claim 34 being previously withdrawn. The previous claim objections and 112 rejections have been withdrawn.
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 1-5, 7-11, 13, 15-17, 21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Williams et al. US Publication 2010/0130844 (hereinafter Williams) in view of Wyatt et al. US Patent 6,368,349 (hereinafter Wyatt).
Regarding claim 1, Williams discloses an implantable electrical/electronic biomedical device (Figure 1) comprising at least one electrode structure deployable by eversion (Figures 3-4 and [0028]), said electrode structure comprising an elastic polymeric support (at elements 26, 28 which are detailed as being made of polymers, see also 32a-f in Figures 3-4 showing the elastic movement) and at least one conductive track disposed on a surface of said elastic polymeric support (track 57 which is on one of the surfaces of 28 which is an overall inner surface).
Williams details that the overall eversion can be accomplished by other methods ([0027]), but does not go into any greater detail. Wyatt teaches an inflatable neural array that includes a reservoir with an inlet and mechanical support on opposing ends (see annotated Figure 2 below). Wyatt additionally teaches an elastic polymeric support (14 can be made of polyimide) and is operatively connected to the reservoir’s inlet through a first end of the support (the microchannels 18 are operatively connected to the inlet in order to function) while the mechanical support shown (near 22, below) is also “operatively connected” in that if one were to move the other element would as well (where the ends 18 and near the central connector 24 are on opposing ends of the polymeric structure). “Operatively connected” being as broad as it is also is met in that fluid/air passes through both the inlet, the mechanical support, as well as both ends of the electrode structure. The claim does not require that the mechanical support has to be in physical contact with the polymeric support of the electrode structure.
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Therefore, it would have been obvious to the skilled artisan before the effective filing date, given the suggestion by Williams to try other methods of deployment, to utilize the reservoir/inlet as taught by Wyatt as predictable results would have ensued (utilizing other known means of array deployment in the brain as is suggested by Williams).
Regarding claim 2, Williams discloses that at least one conductive track is compliant (57).
Regarding claim 3, Williams discloses that a plurality of electrode structures deployable by eversion (each of the spokes 32 is considered an individual electrode structure, see Figures 3-4).
Regarding claim 4, Williams discloses that at least one conductive track is a microelectrode array (the conductive tracks 57 includes multiple electrodes 44, see Figure 5).
Regarding claim 5, Williams discloses that at least one electrode structure is intended to be deployed through a burr hole of a predetermined diameter (Figures 1-2 which shows the structure being deployed through such a hole in the skull) and to cover a predetermined length (d1) in a direction of deployment (dp) when deployed (Figure 1), wherein a ratio of said predetermined length (d1) and said hole diameter (d) is greater than ten (the exact ratio is not detailed, however at least one electrode structure can include electrode structures 32 on opposing sides of the array as shown in Figure 4, where that general combined length is closer to 5 times the size of the opening given what the Figures 1-2 suggest). Given the lack of criticality however, the skilled artisan before the effective filing date would have found it obvious to optimize the sizing to include a slightly larger array (electrode structure) to afford more sensing or to simply reach additional tissue further from the burr hole.
Regarding claim 7, Williams as modified by Wyatt teaches that the reservoir includes a fluid (Wyatt as per column 3 lines 50-56) and the at least one electrode structure includes an opposite surface (the electrode structure of both Williams Figures 3-4, top surface), opposed to said surface, faced to the fluid (the combination of the two references would have a design akin more to what is shown in Wyatt in Figure 2 where the top surfaces faces where the fluid comes into the reservoir closer to the inlet). Initial motivation to combine Williams and Wyatt, see above.
Regarding claim 8, Williams is silent on the fluid/reservoir for deploying the electrode structure. Wyatt teaches that the fluid is a liquid (column 3 lines 50-56 which mentions both air as well as another fluid which is reasonably being considered some type of fluid). Though liquid is never actually mentioned, the skilled artisan before the effective filing date would have reasonably known that the larger class of fluids would encompass liquids. Though fluids include a variety of types, Newtonian, non-Newtonian, ideal/real, ideal plastics, and incompressible/compressible, the skilled artisan before the effective filing date would have limited that list to air or likely saline given the biocompatibility and compressibility requirements. Further, the Applicant does not have any criticality of utilizing a liquid over any other type of fluid and by extension would have been a simple matter of design choice over the “other” fluids disclosed by Wyatt for the same purpose of inflation/deployment of the arrays.
Regarding claim 9, Williams discloses that a direction of deployment of the electrode structure is curved or straight (each of the arms extends outward in a straight direction, Figures 3-4).
Regarding claim 10, Williams discloses that direction of deployment (dp) lays on a plane perpendicular to a direction (di-0) between the inlet and the mechanical support (Figure 4 of Williams shows that the tube 56 extending downward is perpendicularly aligned to the direction of the fully deployed electrode structure).
Regarding claim 11, Williams discloses that the surface on which the conductive track is arranged is not faced to the fluid (the track 57 is on an inner surface and does not face the fluid).
Regarding claim 13, Williams discloses that a width of the inlet of the reservoir and a width of the mechanical support in a direction of deployment (dp) is unchanged by deployment (the widths of none of the elements from either reference in the above combination changes during use).
Regarding claims 15-17, Williams discloses that the electrode structure includes at least three folding lines before deployment (Figure 3 includes a curled shape and as line is technically imaginary and not described as a structural element the pre and post deployment final products must only be the same or cap[able of being shaped in the same fashion, which [0027] points out that an electroactive polymer is used for the eversion step which is fully capable of being shaped as desired with no additional structural modifications). The deployed shaping can be flat as suggested in Figure 4 or could have another shape to conform to tissue, as the material choice allows for this.
Regarding claim 21, Williams discloses that the elastic polymeric support includes carbon nanotube particles, gold particles, platinum particles, diamond particle or a combination thereof (the material choice is never explicitly listed for element 44, which is an electrode located in the claimed area on the elastic polymeric support, however Official Notice is being taken that electrodes on implantable medical devices were well-known to be made of platinum, carbon, and gold, art can be provided as evidence upon request).
Regarding claim 24, Williams discloses that at least some of the conductive tracks or a portion of the electrode structure or a portion of the elastic polymeric support or the mechanical support is operatively connected with at least one sensor configured to measure, detect or analyze at least one parameter (44 which is an electrode designed to sense EEG signals).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Wyatt, and in further view of in view of He et al. US Publication 2006/0173263 (hereinafter He).
Regarding claim 6, Williams though teaches a device that is to be located in the same part of the brain for the same general purpose, the sizing is never disclosed. He teaches a neural sensing device that includes at least one electrode structure has a thickness lower than 300 microns (Figure 5C which shows a size of about 210 microns). Given the lack of criticality for the claimed sizing it would have been obvious to the skilled artisan to optimize the sizing of the electrode structure as taught by He with the device of Williams as a matter of design choice.
Claims 22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Wyatt, and in further view of Bao et al. US Publication 2020/0401042 (hereinafter Bao).
Regarding claim 22, Williams teaches the use of an electroactive polymer which is flexible and biocompatible, but does not explicitly mention it is stretchable (reversibly stretchable). Bao teaches an electroactive polymeric material can also be reversibly stretchable (PEDOT:PSS is biocompatible, electroactive, and stretchable, see abstract, and [0036][00037]). Bao goes on to mention these materials are useful in applications such as implantable medical devices ([0038]). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the material choice as taught by Bao with the device of Williams as predictable results would have ensued (utilizing known materials for their known purpose).
Regarding claim 25, Williams discloses that the elastic polymeric support includes at least two planar membranes stacked one to the other (26 and 28 of Figure 6, though no mention of them being elastomeric is disclosed), wherein a first one of the at least two planar elastomeric membranes supports the conductive tracks and defines the surface of the elastic polymeric support (29 as per Figure 6), and a second one of the at least two planar elastomeric membranes defines an opposite surface of the elastic polymeric support arranged to be faced to a fluid in the reservoir, for deployment (26 is the top portion better shown in Figure 4 which is closer to the inlet of the tube 56 which is where any fluid could come into the system as rendered obvious via Wyatt). Bao teaches materials in similar devices can be elastomeric ([0038] which details a stretchable electroactive polymer). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the material choice as taught by Bao with the device of Williams as predictable results would have ensued (utilizing known materials for their known purpose).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Wyatt, and in further view of in view of Seymour et al. US Publication 2013/0030353 (hereinafter Seymour)
Regarding claim 23, Williams discloses the conductive tracks as mentioned above but is silent on the lighting elements. Seymour teaches an EEG sensing/stimulating device that includes lighting elements (160 which is an LED). It would have been obvious to the skilled artisan before the effective filing date to utilize the lighting elements as taught by Seymour with the device of Williams in order to allow for additional stimulation.
Claims 26-33 are rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Wyatt and Bao, as applied to claim 24, and in further view of in view of He.
Regarding claim 26, Williams discloses that the elastic polymeric support includes two layers but is silent on a third. He teaches that though two layers are shown ([0100]) additional layers such as a third planar elastomeric membrane arranged between the first and the second planar elastomeric membranes can be utilized ([0100]), the third planar elastomeric membrane supports the at least one sensor (all three layers technically “support” the sensor). Given the lack of criticality for the third layer, it would have been obvious to the skilled artisan before the effective filing date to utilize the additional layer as taught by He with the device of Williams as a simple duplication of parts producing predictable results (additional insulation).
Regarding claim 27, Williams disclose that the two layers (26, 28) already surround the conductive track (57), with the sensor at 44, 46 in Figure 6, the additional layer rendered obvious above via He can be found at one of two locations when combined with Williams, either between 26, 28 or on top above 26. In either instance a third layer would still meet the presently claimed limitation. The layers have a thickness and given they are stacked; the third planar membrane and sensor is considered a projection over the first. For motivation to combine He, see above.
Regarding claim 28, Williams discloses a plurality of legs (Figures 3-4 which shows six legs), each leg of the first planar elastomeric membrane includes conductive tracks (57), each leg of the third planar elastomeric membrane includes at least one sensor (third layer rendered obvious above via He at [0100], however the sensor is listed at 44 in Figures 5-6), the at least one sensor on the leg of the third planar elastomeric membrane is arranged so as a projection thereof on the first elastomeric membrane surrounds the conductive tracks of the leg of the first planar elastomeric membrane stacked (see rejected claim 27 above). For motivation to combine He, see above.
Regarding claim 29, Williams discloses that the legs are straight or curved (Figures 3-4 which shows legs that extend outward in a straight fashion, but are curved before full deployment).
Regarding claim 30, Williams discloses that the following parameters are defined for each leg: a leg width w, a thickness h on a straight single leg, a radius of curvature RC on curved legs (Figures 3-4 shows that the legs have a curvature, a thickness, and a width). Wyatt teaches legs that are tapered (Figure 1). It would have been obvious to utilize a change in shape as taught by Wyatt with the device of Williams as predictable results would have ensued (to afford better strain relief and minimize tissue damage).
Regarding claims 31-33, Williams as modified by Wyatt teaches the legs as mentioned above, but is silent to the exact dimensions. Given that the dimensions lack any criticality and that they devices of the prior art of record and the present application are to be utilized in the same area of the brain, it would have been obvious to the skilled artisan before the effective filing date to simply optimize the sizing of the legs as a matter of design choice. Minor variances in sizing would have been predictable in that optimizing the legs to have enough flexibility to not break when deployed while allowing for maximum sensing/stimulating is a common feature in non-Michigan/Utah type arrays (rigid spikes).
Allowable Subject Matter
Claims 12, 14, and 18-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 12, 14, and 18 include additional structure/orientation that the prior art of record (above) is neither capable of nor would be reasonably modified to meet the claim limitation without the use of the Applicant’s original disclosure as a blueprint for doing so. Claims 19-20 depend from claim 18 and fall under the same objection.
Response to Arguments
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive with respect to Williams. The 102 rejection has however been withdrawn.
Williams still meets the limitation regarding the elastic polymeric support due to the “operatively connected” language. Operatively connected has very little required structure or meaning. If the Applicant were to more positively claim that the polymeric support on one end is structurally connected to the reservoir’s inlet and is also structurally connected to the mechanical support on the other, the claim would be allowable. There are several ways to phrase that concept that would be accepted. The structural relationship between these elements is still incredibly broad, but again, if adjusted in small amounts the claims would very likely be allowed without having to incorporate the previously indicated allowable subject matter.
The free end argument would be persuasive if the mechanical support actually had to contact the polymeric support’s second end while the opposing end was in actual contact with the reservoir’s inlet. Based on the combination of record the fluid/air would of Wyatt would have to pass through the one end of the polymeric support (to enter it), then would make it to the other (second) end of the support in order to finish inflating and unfurling the electrode structure. But those ends are fluidically connected to each other and the claimed mechanical support and reservoir inlet, which falls within the larger genus of “operatively connected”. The structural relationship between those three above mentioned elements, if given more detail, would overcome Williams in view of Wyatt.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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