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 1-8 are currently pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the substrate member" in line four. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Kennedy US Publication 2020/0069207 (hereinafter Kennedy).
Regarding claim 1, Kennedy discloses an electrode array, comprising: a flexible substrate member (110) that includes a dielectric material ([0024] which details polyamide, quartz, silicon, where polyamide is flexible), an elongated lead member that includes the dielectric material and that extends from the base adjacent to a selected one of the first side and the second side, is contiguous with the fan-shaped substrate member (lead 124 includes dielectric material 126 around each of the wires); a plurality of wires that are each embedded in the fan-shaped substrate member and the elongated lead member (wires 124, where the wires are within dielectric material of the ribbon 126 and is within the confines of the cone of 110); and a corresponding plurality of electrodes disposed on the flexible substrate member (122 as per Figure 1, which show the electrode disposed on s dielectric ribbon which is then in turn disposed on the substrate; the phrasing does not detail any version of “directly on”, as in intervening layers can still be present), each of which is electrically coupled to a different one of the plurality of wires and each of which includes an exposed surface (122 which connect to wires 124 as per Figure 1).
Kennedy does not disclose the shape of the flexible substrate. As argued below, the claimed shaping is exclusively designed to roll into a cone shape. Claim 1 recites an intermediate step in an apparatus type claim. Kennedy discloses the final shape (Figure 1), which the Applicant does have criticality for. As Kennedy shows the final shape (cone), and given there are a finite number of ways the skilled artisan could make said shape (including rolling a planar substrate, casting, injection molding, etc.), it would have been obvious to the skilled artisan before the effective filing date to start with the shape (2D/planar) as claimed in order to make the final product of Kennedy given the finite, predictable methods of manufacturing for making a cone.
Claims 2-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kennedy in view of Sugihara et al. US Patent 6,151,519 (hereinafter Sugihara).
Regarding claim 2, Kennedy discloses the use of polyamide as the material choice for the dielectric of 110, they are silent as to using polyimide. Sugihara teaches an implantable neural array that includes a dielectric material made of polyimide over another substrate (flexible substrate 2 made of a dielectric material, column 6 lines 4-6 which details polyimide). Given that it is incredibly well-known to utilize polyimide for implantable insulation of electrodes and wires/traces, it would have been obvious to the skilled artisan before the effective filing date to utilize the polyimide of Sugihara in lieu of the polyamide or in addition to the substrate present already as per Kennedy as predictable results would have ensued (better biocompatibility, greater flexibility, and superior electrical/thermal insulation). Given the broadness of the dielectric layer of the claim and how common polyimide is in implantable neural devices, the skilled artisan could either add the material or simply replace it as an art recognized equivalent depending on which material is chosen from Kennedy from [0024].
Regarding claims 3-4, Kennedy discloses an insulating cone that defines a cavity therein that opens to an open base and an oppose open vortex (Figure 1 at element 110 which can be an insulating cone of glass/quartz), which is dielectric in nature however is silent on another dielectric material placed over it. 110 is read differently than in claim 1 under this new interpretation. Sugihara teaches a flexible substrate member with an insulating layer disposed over it (substrate 4 made of polyimide, over insulating layer 3 which is made of the same materials detailed in Kennedy, glass/quartz), and electrodes disposed on the flexible substrate member (electrodes 8 on substrate 4 which is also disposed on insulating layer 3).Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the polyimide layer of Sugihara in addition to the glass substrate and conical shaping of Kennedy as predictable results would have ensued (using polyimide provides better biocompatibility, greater flexibility, and superior electrical/thermal insulation).
Regarding claim 5, Kennedy discloses utilizing a trophic factor placed inside of the cavity defined by the insulating cone ([0025]).
Regarding claim 6, see contents of rejected claims 1, 3-4 above.
Regarding claim 7, see contents of rejected claim 2 above.
Regarding claim 8, see contents of rejected claims 3-5 above.
Response to Arguments
Applicant's arguments filed 04/30/2026 have been fully considered but they are not persuasive.
The Applicant is again arguing that a product by process type limitation (intermediate step) is to be given greater weight in an apparatus type claim. The “triangular portion with a convexly curved base from which a first side and an opposite second side extend to a truncated apex that includes a concavely curved surface” as is now described regarding the flexible substrate is an intermediate step/shape in order to make the cone described in the arguments, original specification, and claims 3/6. The step of rolling the substrate into a cone is a process type limitation (see MPEP 2113), where so long as the final product is the same, the process in order to arrive at that shape is still considered anticipated. The cone shape can be made by multiple types of methods such as in the present case of rolling a planar substrate into a 3D one, or simply by injection molding the shape all at once (as is likely the case in Kennedy ‘207 above), both create the exact same shape.
Regarding the physical amendments to the claims, the substrate member of Kennedy can also be polyamide which is not only flexible, but also considered elastic, meeting the limitation ([0024]). As for the “disposed on” language with respect to the electrodes on the substrate, this is also unpersuasive. Disposed on does not mean that the two elements have to be in direct contact with each other. Formed on, in direct contact with, etc. are more appropriate and actually mean what the Applicant is arguing.
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.
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
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