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 .
Response to Amendment
The amendment filed on April 20, 2026 was considered by the examiner. Claims 1, 3-11, and 13-21 are pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 17, 2025 and July 28, 2026 were considered by the examiner. The IDS submitted on April 21, 2026 was considered by the examiner, except foreign patent document cite number 12 which was not included in the file wrapper.
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.
Claims 1, 3-11, and 13-21 are 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 1 recites the limitation “the brain” in line 3. There is insufficient antecedent basis for this limitation in the claim. Furthermore, claim 1 recites “a brain” in line 9, which appears to be related the recitation of “the brain” in line 3; however, the usage of the indefinite article “a” suggests that they are not related. Amending the recitation in line 3 to “a brain” and amending the recitation in line 9 to “the brain” would overcome these rejection. The claim is being read as such for the purposes of examination.
Claims 3-10 are rejected by virtue of their dependence from claim 1.
Claim 5 recites “the modules are removably couplable together by aligning a first alignment guide in a preceding module with a second alignment guide in a succeeding module of the plurality of modules” in lines 1-3. The specification only details alignment holes as a modality of alignment guides (see specification ¶[0020] and ¶[0124]). Therefore, it is not clear what additional alignment feature is being recited in claim 5, as alignment holes are recited in claim 1, lines 11-13. This inconsistency renders claim 5 indefinite. For the purposes of examination, the alignment guides of claim 5 are being interpreted as the alignment holes of claim 1.
Claim 11 recites the limitation “the brain” in line 4. There is insufficient antecedent basis for this limitation in the claim. Furthermore, claim 11 recites “a brain” in line 11, which appears to be related the recitation of “the brain” in line 4; however, the usage of the indefinite article “a” suggests that they are not related. Amending the recitation in line 4 to “a brain” and amending the recitation in line 11 to “the brain” would overcome these rejection. The claim is being read as such for the purposes of examination.
Claims 13-21 are rejected by virtue of their dependence from claim 11.
Claim 15 recites “the modules are removably couplable together by aligning a first alignment guide in a preceding module with a second alignment guide in a succeeding module of the plurality of modules” in lines 1-3. The specification only details alignment holes as a modality of alignment guides (see specification ¶[0020] and ¶[0124]). Therefore, it is not clear what additional alignment feature is being recited in claim 15, as alignment holes are recited in claim 11, lines 13-15. This inconsistency renders claim 15 indefinite. For the purposes of examination, the alignment guides of claim 15 are being interpreted as the alignment holes of claim 11.
Claim 20 recites the limitation “the insertion paddle” in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 5-8, 11, and 15-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/148,656 in view of Wijesundara et al. (US Patent Application Publication 2020/0078586 – cited by Applicant), hereinafter Wijesundara. This is a provisional nonstatutory double patenting rejection.
Regarding Claims 1, 5-8, 11, and 15-18, copending claims 1-3 have all of the features of claims 1, 5-8, 11, 15-18 of the present application, except that that the modules are aligned via holes at the proximal and distal regions.
Wijesundara teaches an apparatus for stimulating and/or monitoring a nerve involving a top and bottom substrate layer, with electrodes disposed therebetween (see abstract and 1A-3C), in which a spacing layer 150 may be utilized involving polyimide film and adhesive (see ¶[0039] and ¶[0055]-[0056]; Figs. 1A-2), and that the top and bottom portions may be aligned with guidance markings (holes) 170 (see ¶[0051] and Figs. 4A-4C).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the alignment holes of Wijesundara at the proximal and distal regions of the modules of the copending claims 1-3 because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) the copending claims 1-3 requires that the modules be aligned for attachment to one another and Wijesundara teaches one such modality of alignment; and/or (3) the alignment holes would provide visual confirmation that the modules are properly aligned.
Claims 3-4, 9, 13-14, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/148,656 in view of Wijesundara as applied to claims 1 and 11 above, and in view of Kipke et al. (US Patent Application Publication 2013/0144365 – cited by Applicant), hereinafter Kipke. This is a provisional nonstatutory double patenting rejection.
Regarding Claims 3-4 and 13-14, the modified copending claims 1-3 have all of the features of claims 3-4 and 13-14 of the present application, except that adhesive is utilized on the overlapping region.
Kipke teaches an apparatus comprising a flexible substrate including a modular electrode array (see abstract and Figs. 1-2). Kipke teaches a neural interface for intradural implantation (see abstract, ¶[0002]-[0003], ¶[0020], and ¶[0024] modular electrode array of the neural device is intended for use with the surface of the brain, such as electrocorticography, ECoG), an adhesive is applied to an overlapping region of the proximal holes of the preceding module and the distal holes of the succeeding module of the plurality of modules (see ¶[0030] the modules may be coupled together via epoxy/adhesive at the adjoining surfaces, the adjoining surfaces are the proximal/distal regions joined in the modules, ¶[0032] the adhesive may be cyanoacrylate adhesive; Figs. 1-2 and 4).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the cyanoacrylate adhesive of Kipke with the modules of the modified copending claims 1-3 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the modified copending claims 1-3 require an adhesive, and Kipke teaches one such adhesive.
Regarding Claims 9 and 19, the modified copending claims 1-3 have all of the features of claims 9 and 19 of the present application, except that each of the plurality of modules comprises 1,024 channel arrays.
Kipke teaches an apparatus comprising a flexible substrate including a modular electrode array (see abstract and Figs. 1-2). Kipke teaches a neural interface for intradural implantation (see abstract, ¶[0002]-[0003], and ¶[0024] modular electrode array of the neural device is intended for use with the surface of the brain, such as electrocorticography, ECoG), the neural interface comprising:
a flexible substrate (¶[0015]-[0016] and ¶[0021] the flexible substrate and/or the flexible backing 470; Figs. 1-2 and 4),
wherein the flexible substrate comprises a first bioinert material (¶[0016] the substrate may be a polymer, such as polyimide, since the device is implanted into the brain (i.e., ECoG), it is inherent that the microelectrodes would be bioinert, the present application also indicates that polyimide is bioinert, so the polyimide taught by Kipke would be bioinert; Figs. 1-2 and 4);
a plurality of modules disposed on a second side of the flexible substrate (¶[0015]-[0021] the modular electrode arrays, each array comprising multiple electrodes; Figs. 1-2 and 4), and
a first side of the flexible substrate, wherein the second side opposes the first side (¶[0015]-[0021] the side of the module without the electrodes, the opposite side; Figs. 1-2 and 4),
wherein each of the modules comprises a plurality of microelectrodes (¶[0015]-[0021] the modular electrode arrays, each array comprising multiple electrodes; Figs. 1-2 and 4),
wherein the modules are removably connected together (¶[0030] the modules may be coupled together via epoxy/adhesive at the adjoining surfaces, ¶[0032] the adhesive may be cyanoacrylate adhesive; Figs. 1-2 and 4), and
wherein the microelectrodes do not penetrate a surface of a brain against which the microelectrodes are positioned and comprise a second bioinert material (¶[0018] the electrode modules may include penetrating electrodes in some embodiments, indicating that the standard microelectrodes do not penetrate, since the device is implanted into the brain (i.e., ECoG), it is inherent that the microelectrodes would be bioinert); and
wherein the plurality of microelectrode arrays comprises 1,024 channel arrays (¶[0019]-[0020] various pluralities of microelectrodes are contemplated, comparison of the modules to traditional ECoG at 1024 to 64 electrodes, in similar sized area).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the 1024 channel electrode array of Kipke with the modules of the modified copending claims 1-3 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the modified copending claims 1-3 require a channel amount, and Kipke teaches one such channel amount.
As an alternative interpretation, the plurality of modules may be considered a module itself (i.e., a bigger module could still be combined, it would still be considered a module), thus comprising 1024 channels. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the module (i.e., two modules with 1024 channels each) because this would be a mere duplication of parts that has no patentable significance because there is no new and unexpected result (see MPEP 2144.04(VI)(B)). In this case, the two modules would be able to sample a larger area, which would not be new or unexpected.
Claim 20 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/148,656 in view of Wijesundara as applied to claim 11 above, and in view of Sage (US Patent Application Publication 2013/0331856 – cited by Applicant). This is a provisional nonstatutory double patenting rejection.
Regarding Claim 20, the modified copending claims 1-3 have all of the features of claim 20 of the present application, except that the insertion paddle comprises a rigid material.
Sage teaches a combined dissection tool and blank for implanting a paddle lead including electrodes (see abstract), in which the distal portion 154 of the guide wire 152 (paddle type stylet) may be flattened to achieve specific desired steering movements (see ¶[0057]-[0059] the flattened (paddle) stylet bends easier perpendicular to the flattened surface 162, but to resist bending generally in direction 160 parallel to the flattened surface 162; Figs. 5A-5B).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the rigid material of the flattened (paddle) stylet of Sage with the stylet of the modified copending claims 1-3 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the flattened (paddle) stylet can help to steer in the specific desired steering movement of Sage (see Sage ¶[0057]-[0058]).
Claims 10 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/148,656 in view of Wijesundara as applied to claims 1 and 11 above, and in view of Kipke, and in view of Pianca et al. (US Patent Application Publication 2014/0100586 – cited by Applicant), hereinafter Pianca. This is a provisional nonstatutory double patenting rejection.
Regarding Claims 10 and 21, the modified copending claims 1-3 have all of the features of claims 10 and 21 of the present application, except that the first bioinert material comprises a polyimide and the second bioinert material comprises at least one of titanium or platinum.
Kipke teaches an apparatus comprising a flexible substrate including a modular electrode array (see abstract and Figs. 1-2). Kipke teaches a neural interface for intradural implantation (see abstract, ¶[0002]-[0003], and ¶[0024] modular electrode array of the neural device is intended for use with the surface of the brain, such as electrocorticography, ECoG), the neural interface comprising:
a flexible substrate (¶[0015]-[0016] and ¶[0021] the flexible substrate and/or the flexible backing 470; Figs. 1-2 and 4),
wherein the flexible substrate comprises a first bioinert material (¶[0016] the substrate may be a polymer, such as polyimide, since the device is implanted into the brain (i.e., ECoG), it is inherent that the microelectrodes would be bioinert, the present application also indicates that polyimide is bioinert, so the polyimide taught by Kipke would be bioinert; Figs. 1-2 and 4);
a plurality of modules disposed on a second side of the flexible substrate (¶[0015]-[0021] the modular electrode arrays, each array comprising multiple electrodes; Figs. 1-2 and 4), and
a first side of the flexible substrate, wherein the second side opposes the first side (¶[0015]-[0021] the side of the module without the electrodes, the opposite side; Figs. 1-2 and 4),
wherein each of the modules comprises a plurality of microelectrodes (¶[0015]-[0021] the modular electrode arrays, each array comprising multiple electrodes; Figs. 1-2 and 4),
wherein the modules are removably connected together (¶[0030] the modules may be coupled together via epoxy/adhesive at the adjoining surfaces, ¶[0032] the adhesive may be cyanoacrylate adhesive; Figs. 1-2 and 4), and
wherein the microelectrodes do not penetrate a surface of a brain against which the microelectrodes are positioned and comprise a second bioinert material (¶[0018] the electrode modules may include penetrating electrodes in some embodiments, indicating that the standard microelectrodes do not penetrate, since the device is implanted into the brain (i.e., ECoG), it is inherent that the microelectrodes would be bioinert); and
wherein the plurality of microelectrode arrays comprises 1,024 channel arrays (¶[0019]-[0020] various pluralities of microelectrodes are contemplated, comparison of the modules to traditional ECoG at 1024 to 64 electrodes, in similar sized area).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the polyimide first bioinert material of Kipke as the material for the flexible substrate of the modified copending claims 1-3 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the modified copending claims 1-3 require a flexible substrate material and Kipke teaches one such material.
The modified copending claims 1-3 are silent that the second bioinert material comprises at least one of titanium or platinum.
Pianca teaches various embodiments of an insertion tool for a paddle-style electrode (see abstract), which may utilize a longitudinal ridge 49 opposite the electrode side for receiving an insertion stylet 40 within a lumen 46 and an enclosed distal portion 48 (see ¶[0062] and Figs. 8A-8C), and that the electrode contacts may comprise platinum or platinum-iridium as known in the art (see ¶[0053]),
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the platinum or platinum-iridium electrode contact of Pianca as the material for the electrodes of the modified copending claims 1-3 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the modified copending claims 1-3 require an electrode material and Pianca teaches one such material known in the art.
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 nonobviousness.
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.
Claims 1, 3-6, 8-11, 13-16, and 18-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Kipke et al. (US Patent Application Publication 2013/0144365 – cited by Applicant), hereinafter Kipke, and in view of Pianca et al. (US Patent Application Publication 2014/0100586 – cited by Applicant), hereinafter Pianca, and in view of Wijesundara et al. (US Patent Application Publication 2020/0078586 – cited by Applicant), hereinafter Wijesundara.
Regarding Claim 1, Kipke teaches an apparatus comprising a flexible substrate including a modular electrode array (see abstract and Figs. 1-2). Kipke teaches a neural interface for intradural implantation (see abstract, ¶[0002]-[0003], ¶[0020], and ¶[0024] modular electrode array of the neural device is intended for use with the surface of the brain, such as electrocorticography, ECoG), the neural interface comprising:
a flexible substrate (¶[0015]-[0016] and ¶[0021] the flexible substrate and/or the flexible backing 470; Figs. 1-2 and 4) that resides on a target region of a cortical surface of the brain (see abstract, ¶[0002]-[0003], ¶[0020], and ¶[0024] modular electrode array of the neural device is intended for use with the surface of the brain, ECoG electrodes are intended for use on cortical surfaces),
wherein the flexible substrate comprises a first bioinert material (¶[0016] the substrate may be a polymer, such as polyimide, since the device is implanted into the brain (i.e., ECoG), it is inherent that the microelectrodes would be bioinert, the present application also indicates that polyimide is bioinert, so the polyimide taught by Kipke would be bioinert; Figs. 1-2 and 4);
a plurality of modules disposed on a second side of the flexible substrate (¶[0015]-[0021] the modular electrode arrays, each array comprising multiple electrodes; Figs. 1-2 and 4), and
a first side of the flexible substrate, wherein the second side opposes the first side (¶[0015]-[0021] the side of the module without the electrodes, the opposite side; Figs. 1-2 and 4),
wherein each of the modules comprises a plurality of microelectrodes (¶[0015]-[0021] the modular electrode arrays, each array comprising multiple electrodes; Figs. 1-2 and 4),
wherein the modules are removably connected together (¶[0030] the modules may be coupled together via epoxy/adhesive at the adjoining surfaces, ¶[0032] the adhesive may be cyanoacrylate adhesive; Figs. 1-2 and 4), and
wherein the microelectrodes do not penetrate the cortical surface of a brain against which the microelectrodes are positioned and comprise a second bioinert material (¶[0018] the electrode modules may include penetrating electrodes in some embodiments, indicating that the standard microelectrodes do not penetrate, since the device is implanted into the brain (i.e., ECoG), it is inherent that the microelectrodes would be bioinert);
wherein each of the modules comprises proximal regions and distal regions; and the modules are removably coupled together by aligning the proximal region of a preceding module with the distal region of a succeeding module of the plurality of modules (¶[0030] the modules may be coupled together via epoxy/adhesive at the adjoining surfaces, the adjoining surfaces are the proximal/distal regions joined in the modules, ¶[0032] the adhesive may be cyanoacrylate adhesive; Figs. 1-2 and 4).
Alternatively and/or additionally, Pianca teaches various embodiments of an insertion tool for a paddle-style electrode (see abstract), which may utilize a longitudinal ridge 49 opposite the electrode side for receiving an insertion stylet 40 within a lumen 46 and an enclosed distal portion 48 (see ¶[0062] and Figs. 8A-8C). Pianca further teaches that the electrode contacts may comprise platinum or platinum-iridium as known in the art (see ¶[0053]),
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the platinum or platinum-iridium electrode contact of Pianca as the material for the electrodes of the modified Kipke because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) Kipke requires an electrode material and Pianca teaches one such material known in the art.
The modified Kipke does not specifically teach that the modules are aligned via holes at the proximal and distal regions.
Wijesundara teaches an apparatus for stimulating and/or monitoring a nerve involving a top and bottom substrate layer, with electrodes disposed therebetween (see abstract and 1A-3C), in which a spacing layer 150 may be utilized involving polyimide film and adhesive (see ¶[0039] and ¶[0055]-[0056]; Figs. 1A-2), and that the top and bottom portions may be aligned with guidance markings (holes) 170 (see ¶[0051] and Figs. 4A-4C).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the alignment holes of Wijesundara at the proximal and distal regions of the modules of the modified Kipke because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) Kipke requires that the modules be aligned for attachment to one another and Wijesundara teaches one such modality of alignment; and/or (3) the alignment holes would provide visual confirmation that the modules are properly aligned.
Regarding Claim 3, Kipke in view of Pianca and Wijesundara teaches the device of claim 1 as stated above. The modified Kipke further teaches an adhesive is applied to an overlapping region of the proximal holes of the preceding module and the distal holes of the succeeding module of the plurality of modules (see Kipke ¶[0030] the modules may be coupled together via epoxy/adhesive at the adjoining surfaces, the adjoining surfaces are the proximal/distal regions joined in the modules, ¶[0032] the adhesive may be cyanoacrylate adhesive, Figs. 1-2 and 4; see Wijesundara ¶[0051] the top and bottom portions may be aligned with guidance markings (holes) 170 the top and bottom portions may be aligned with guidance markings (holes) 170, Figs. 4A-4C).
Regarding Claim 4, Kipke in view of Pianca and Wijesundara teaches the device of claim 3 as stated above. Kipke further teaches the adhesive comprises cyanoacrylate (¶[0032] the adhesive may be cyanoacrylate adhesive).
Regarding Claim 5, Kipke in view of Pianca and Wijesundara teaches the device of claim 1 as stated above. The modified Kipke further teaches the modules are removably couplable together by aligning a first alignment guide in a preceding module with a second alignment guide in a succeeding module of the plurality of modules (see Kipke ¶[0030] the modules may be coupled together via epoxy/adhesive at the adjoining surfaces, the adjoining surfaces are the proximal/distal regions joined in the modules, ¶[0032] the adhesive may be cyanoacrylate adhesive, Figs. 1-2 and 4; see Wijesundara ¶[0039] and ¶[0055]-[0056] and Figs. 1A-2, the spacing layer 150 may be utilized involving polyimide film and adhesive, and see ¶[0051] and Figs. 4A-4C, the top and bottom portions may be aligned with guidance markings (holes) 170). The alignment holes are the alignment guides.
Regarding Claim 6, Kipke in view of Pianca and Wijesundara teaches the device of claim 1 as stated above. Kipke further teaches the microelectrodes are distributed evenly in the modules (¶[0017] the microelectrodes may be arranged in a regular pattern, such as an approximately rectangular grid; Figs. 1-3).
Regarding Claim 8, Kipke in view of Pianca and Wijesundara teaches the device of claim 1 as stated above. Kipke further teaches the microelectrodes are configured for at least one of recording or stimulation (¶[0024] the neural device is capable of recording (i.e., the mapping) and/or stimulation).
Regarding Claim 9, Kipke in view of Pianca and Wijesundara teaches the device of claim 1 as stated above. Kipke further teaches of the plurality of modules comprises 1,024 channels (¶[0019]-[0020] the various pluralities of microelectrodes are contemplated, comparison of the modules to traditional ECoG at 1024 to 64 electrodes, in similar sized area).
The modified Kipke does not specifically teach that each module may comprise 1024 channels.
As an alternative interpretation, the plurality of modules may be considered a module itself (i.e., a bigger module could still be combined, it would still be considered a module), thus comprising 1024 channels. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the module (i.e., two modules with 1024 channels each) because this would be a mere duplication of parts that has no patentable significance because there is no new and unexpected result (see MPEP 2144.04(VI)(B)). In this case, the two modules would be able to sample a larger area, which would not be new or unexpected.
Regarding Claim 10, Kipke in view of Pianca and Wijesundara teaches the device of claim 1 as stated above. The modified Kipke further teaches the first bioinert material comprises a polyimide (see Kipke ¶[0016] the substrate may be a polymer, such as polyimide; Figs. 1-2 and 4) and the second bioinert material comprises at least one of titanium or platinum (see Pianca ¶[0053] the electrode contacts may comprise platinum or platinum-iridium as known in the art).
Regarding Claim 11, Kipke teaches an apparatus comprising a flexible substrate including a modular electrode array (see abstract and Figs. 1-2). Kipke teaches a surgical system comprising: a neural interface for intradural implantation (see abstract, ¶[0002]-[0003], and ¶[0024] modular electrode array of the neural device is intended for use with the surface of the brain, such as electrocorticography, ECoG), the neural interface comprising:
a flexible substrate (¶[0015]-[0016] and ¶[0021] the flexible substrate and/or the flexible backing 470; Figs. 1-2 and 4) that resides on a target region of a cortical surface of the brain (see abstract, ¶[0002]-[0003], ¶[0020], and ¶[0024] modular electrode array of the neural device is intended for use with the surface of the brain, ECoG electrodes are intended for use on cortical surfaces),
wherein the flexible substrate comprises a first bioinert material (¶[0016] the substrate may be a polymer, such as polyimide, since the device is implanted into the brain (i.e., ECoG), it is inherent that the microelectrodes would be bioinert, the present application also indicates that polyimide is bioinert, so the polyimide taught by Kipke would be bioinert; Figs. 1-2 and 4); and
a plurality of modules disposed on a second side of the flexible substrate (¶[0015]-[0021] the modular electrode arrays, each array comprising multiple electrodes; Figs. 1-2 and 4), and
a first side of the flexible substrate, wherein the second side opposes the first side (¶[0015]-[0021] the side of the module without the electrodes, the opposite side; Figs. 1-2 and 4),
wherein each of the modules comprises a plurality of microelectrodes (¶[0015]-[0021] the modular electrode arrays, each array comprising multiple electrodes; Figs. 1-2 and 4),
wherein the modules are removably connected together (¶[0030] the modules may be coupled together via epoxy/adhesive at the adjoining surfaces, ¶[0032] the adhesive may be cyanoacrylate adhesive; Figs. 1-2 and 4), and
wherein the microelectrodes do not penetrate the cortical surface of a brain against which the microelectrodes are positioned and comprise a second bioinert material (¶[0018] the electrode modules may include penetrating electrodes in some embodiments, indicating that the standard microelectrodes do not penetrate, since the device is implanted into the brain (i.e., ECoG), it is inherent that the microelectrodes would be bioinert);
wherein each of the modules comprises proximal regions and distal regions; and the modules are removably coupled together by aligning the proximal region of a preceding module with the distal region of a succeeding module of the plurality of modules (¶[0030] the modules may be coupled together via epoxy/adhesive at the adjoining surfaces, the adjoining surfaces are the proximal/distal regions joined in the modules, ¶[0032] the adhesive may be cyanoacrylate adhesive; Figs. 1-2 and 4).
Alternatively and/or additionally, Pianca teaches various embodiments of an insertion tool for a paddle-style electrode (see abstract), which may utilize a longitudinal ridge 49 opposite the electrode side for receiving an insertion stylet 40 within a lumen 46 and an enclosed distal portion 48 (see ¶[0062] and Figs. 8A-8C). Pianca further teaches that the electrode contacts may comprise platinum or platinum-iridium as known in the art (see ¶[0053]),
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the platinum or platinum-iridium electrode contact of Pianca as the material for the electrodes of the modified Kipke because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) Kipke requires an electrode material and Pianca teaches one such material known in the art.
The modified Kipke does not specifically teach that the modules are aligned via holes at the proximal and distal regions.
Wijesundara teaches an apparatus for stimulating and/or monitoring a nerve involving a top and bottom substrate layer, with electrodes disposed therebetween (see abstract and 1A-3C), in which a spacing layer 150 may be utilized involving polyimide film and adhesive (see ¶[0039] and ¶[0055]-[0056]; Figs. 1A-2), and that the top and bottom portions may be aligned with guidance markings (holes) 170 (see ¶[0051] and Figs. 4A-4C).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the alignment holes of Wijesundara at the proximal and distal regions of the modules of the modified Kipke because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) Kipke requires that the modules be aligned for attachment to one another and Wijesundara teaches one such modality of alignment; and/or (3) the alignment holes would provide visual confirmation that the modules are properly aligned.
Regarding Claim 13, Kipke in view of Pianca, and Wijesundara teaches the device of claim 11 as stated above. The modified Kipke further teaches an adhesive is applied to an overlapping region of the proximal holes of the preceding module and the distal holes of the succeeding module of the plurality of modules (see Kipke ¶[0030] the modules may be coupled together via epoxy/adhesive at the adjoining surfaces, the adjoining surfaces are the proximal/distal regions joined in the modules, ¶[0032] the adhesive may be cyanoacrylate adhesive, Figs. 1-2 and 4; see Wijesundara ¶[0051] the top and bottom portions may be aligned with guidance markings (holes) 170 the top and bottom portions may be aligned with guidance markings (holes) 170, Figs. 4A-4C).
Regarding Claim 14, Kipke in view of Pianca, and Wijesundara teaches the device of claim 13 as stated above. Kipke further teaches the adhesive comprises cyanoacrylate (¶[0032] the adhesive may be cyanoacrylate adhesive).
Regarding Claim 15, Kipke in view of Pianca and Wijesundara teaches the device of claim 11 as stated above. The modified Kipke further teaches the modules are removably couplable together by aligning a first alignment guide in a preceding module with a second alignment guide in a succeeding module of the plurality of modules (see Kipke ¶[0030] the modules may be coupled together via epoxy/adhesive at the adjoining surfaces, the adjoining surfaces are the proximal/distal regions joined in the modules, ¶[0032] the adhesive may be cyanoacrylate adhesive, Figs. 1-2 and 4; see Wijesundara ¶[0039] and ¶[0055]-[0056] and Figs. 1A-2, the spacing layer 150 may be utilized involving polyimide film and adhesive, and see ¶[0051] and Figs. 4A-4C, the top and bottom portions may be aligned with guidance markings (holes) 170). The alignment holes are the alignment guides.
Regarding Claim 16, Kipke in view of Pianca and Wijesundara teaches the device of claim 11 as stated above. Kipke further teaches the microelectrodes are distributed evenly in the modules (¶[0017] the microelectrodes may be arranged in a regular pattern, such as an approximately rectangular grid; Figs. 1-3).
Regarding Claim 18, Kipke in view of Pianca and Wijesundara teaches the device of claim 11 as stated above. Kipke further teaches the microelectrodes are configured for at least one of recording or stimulation (¶[0024] the neural device is capable of recording (i.e., the mapping) and/or stimulation).
Regarding Claim 19, Kipke in view of Pianca and Wijesundara teaches the device of claim 11 as stated above. Kipke further teaches of the plurality of modules comprises 1,024 channels (¶[0019]-[0020] various pluralities of microelectrodes are contemplated, comparison of the modules to traditional ECoG at 1024 to 64 electrodes, in similar sized area).
The modified Kipke does not specifically teach that each module may comprise 1024 channels.
As an alternative interpretation, the plurality of modules itself is a module, thus comprising 1024 channels. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the module (i.e., two modules with 1024 channels each) because this would be a mere duplication of parts that has no patentable significance because there is no new and unexpected result (see MPEP 2144.04(VI)(B)). In this case, the two modules would be able to sample a larger area, which would not be new or unexpected.
Regarding Claim 21, Kipke in view of Pianca and Wijesundara teaches the device of claim 11 as stated above. The modified Kipke further teaches the first bioinert material comprises a polyimide (see Kipke ¶[0016] the substrate may be a polymer, such as polyimide; Figs. 1-2 and 4) and the second bioinert material comprises at least one of titanium or platinum (see Pianca ¶[0053] the electrode contacts may comprise platinum or platinum-iridium as known in the art).
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kipke in view of and Wijesundara as applied claims 1 and 11 above, respectively, and in view of Brinkmann et al. (US Patent Application Publication 2019/0150774 – cited by Applicant), hereinafter Brinkmann.
Regarding Claim 7, Kipke in view of Pianca and Wijesundara teaches the device of claim 1 as stated above. The modified Kipke does not specifically teach that the microelectrodes have a diameter of 20–200 µm.
Brinkmann teaches about multiscale brain electrodes and their applications (see abstract) in which the microelectrodes may have a diameter of 10-100 µm with a spacing of 100-1000 µm (see ¶[0056] and ¶[0154]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the small microelectrode diameter of Brinkmann with the microelectrodes of the modified Kipke because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the smaller size would enable higher resolution given a neural device of the same size with an increased number of microelectrodes capable of fitting.
The 10-100 µm range of the modified Kipke suggests the range of the present claim because 20–200 µm overlaps with the range of 10-100 µm. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding Claim 17, Kipke in view of Pianca and Wijesundara teaches the device of claim 11 as stated above. The modified Kipke does not specifically teach that the microelectrodes have a diameter of 20–200 µm.
Brinkmann teaches about multiscale brain electrodes and their applications (see abstract) in which the microelectrodes may have a diameter of 10-100 µm with a spacing of 100-1000 µm (see ¶[0056] and ¶[0154]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the small microelectrode diameter of Brinkmann with the microelectrodes of the modified Kipke because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the smaller size would enable higher resolution given a neural device of the same size with an increased number of microelectrodes capable of fitting.
The 10-100 µm range of the modified Kipke suggests the range of the present claim because 20–200 µm overlaps with the range of 10-100 µm. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kipke in view of and Wijesundara as applied claim 11 above, and in view of Sage (US Patent Application Publication 2013/0331856 – cited by Applicant).
Regarding Claim 20, Kipke in view of Pianca and Wijesundara teaches the device of claim 11 as stated above. The modified Kipke is silent regarding a pocket disposed on the first side of the flexible substrate for an insertion paddle.
Pianca further teaches various embodiments of an insertion tool for a paddle-style electrode (see abstract), which may utilize a longitudinal ridge 49 opposite the electrode side for receiving an insertion stylet 40 within a lumen 46 and an enclosed distal portion 48 (see ¶[0062] and Figs. 8A-8C), in which the insertion stylet 40 may be a flexible metal wire (see ¶[0060]). Here, as the end of the longitudinal ridge is enclosed, it is a pocket.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the pocket and stylet insertion modality of Pianca with the neural device of the modified Kipke because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the modified Kipke requires an implantation/insertion modality for the neural device and Pianca teaches one such modality; and/or (3) the pocket and stylet combination provide steering for the neural device (see Pianca ¶[0062]).
The modified Kipke does not specifically teach that the stylet is a paddle type stylet with a rigid material (see present application specification ¶[0138], the stylet is generic to the specific genus paddle).
Sage teaches a combined dissection tool and blank for implanting a paddle lead including electrodes (see abstract), in which the distal portion 154 of the guide wire 152 (paddle type stylet) may be flattened to achieve specific desired steering movements (see ¶[0057]-[0059] the flattened (paddle) stylet bends easier perpendicular to the flattened surface 162, but to resist bending generally in direction 160 parallel to the flattened surface 162; Figs. 5A-5B).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the flattened (paddle) stylet of Sage with the stylet of the modified Kipke because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the flattened (paddle) stylet can help to steer in the specific desired steering movement of Sage (see Sage ¶[0057]-[0058]).
Response to Arguments
Applicant’s arguments, objections to the specification
Applicant’s arguments, see pg. 8, filed April 20, 2026, with respect to the objections to the specification have been fully considered and are persuasive. Therefore, the objections have been withdrawn.
Applicant’s arguments, objections to the claims
Applicant’s arguments, see pg. 8, filed April 20, 2026, with respect to the objections to claims 6-9 and 16-19 have been fully considered and are persuasive. Therefore, the objections have been withdrawn.
Applicant’s arguments, objections to the drawings
Applicant’s arguments, see pg. 8, filed April 20, 2026, with respect to the objections to the drawings have been fully considered and are persuasive. Therefore, the objections have been withdrawn, except for the objections to Figs. 10B-10C, because they contain aberrational letters and lead lines without reference characters.
Applicant’s arguments, 35 U.S.C. § 112(b)
Applicant’s arguments, see pg. 9, filed April 20, 2026, with respect to the rejections of claims 6, 9, 16, and 19-20 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection are made that were necessitated by Applicant’s amendment filed on April 20, 2026.
Applicant’s arguments, 35 U.S.C. § 103
Applicant’s arguments, see pg. 9-12, filed April 20, 2026, with respect to the rejections of claims 1-21 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection are made in view of Wijesundara et al. (US Patent Application Publication 2020/0078586 – cited by Applicant).
Applicant’s arguments, see pg. 9-11, filed April 20, 2026, with respect to the rejections of claim 1 under 35 U.S.C. § 103 have been fully considered and are NOT persuasive. In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant’s arguments with regard to Pianca are not persuasive as Pianca was not used to teach the flexible substrate element. Applicant’s arguments with regard to Wijesundara are not persuasive as Wijesundara was not used in isolation to teach such claimed elements. Wijesundara teaches that the top and bottom portions may be aligned with guidance markings (holes) 170 (see ¶[0051] and Figs. 4A-4C), that in combination with the other references, teaches the claimed subject matter. Therefore, Applicant’s arguments are not persuasive.
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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/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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