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 December 29, 2026 was considered by the examiner. Claims 1-16 are pending in the application. Claims 5-12 are withdrawn.
Drawings
The drawings are objected to because:
Figs. 10B-10C contain aberrational letters and lead lines without reference characters.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 13 are objected to because of the following informalities:
in claim 1, line 12: “patient’s skull” should be “subject’s skull”; and
in claim 13, line 8: change “polymide” to “polyimide”.
Appropriate correction is required.
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 13-16 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 13 recites the limitation "the brain" in line 4. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to “a brain” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claims 14-16 are rejected by virtue of their dependence from claim 13.
Claim 14 recites the limitation "the brain" in line 4. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to “a brain” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claim 14 recites “the respective pocket” in line 11, but it is not clear if this recitation is referring to the recitation “a pocket” in claim 13, line 3; the recitation “an inner pocket” in claim 13, line 8; or something else. If this recitations is the same as the recitation of claim 13, line 3, the present recitation should be “the pocket”. If this recitations is the same as the recitation of claim 13, line 8, the present recitation should be “the inner pocket”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, this recitation is being interpreted as “the pocket”.
Claim 14 recites “the patient’s skull” in line 13 and “the subject” in line 14. There is insufficient antecedent basis for these limitations in the claim. This limitations appear to be the same/related. Amending the recitation of line 13 to “a subject’s skull” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claims 15-16 are rejected by virtue of their dependence from claim 14.
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 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-17 of copending Application No. 18/380,918 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claims 1-3, copending claims 16-17 have all of the features of claims 1-3 of the present application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 4 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of copending Application No. 18/380,918 (reference application) in view of Brinkmann et al. (US Patent Application Publication 2019/0150774 – cited by Applicant), hereinafter Brinkmann.
This is a provisional nonstatutory double patenting rejection.
Regarding Claim 4, copending claim 11 has all of the features of claim 4 of the present application, except that the intra-electrode spacing of the electrodes is less than 400 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 and spacing of Brinkmann with the microelectrodes of copending claim 11 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 and spacing requirements would enable higher resolution given a neural device of the same size with an increased number of microelectrodes capable of fitting.
The 100-1000 µm range of copending claim 11 suggests the range of the present claim because less than 400 µm overlaps with the range of 100-1000 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)”.
Claims 13-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13, 16-17, and 21 of copending Application No. 18/380,918 (reference application) in view of Renner et al. (US Patent Application Publication 2023/0320417 – cited in prior action), hereinafter Renner.
Regarding Claims 13-16, copending claims 13, 16-17, and 21 have all of the features of claims 13-16 of the present application, except the manufacture of the polyimide pocket.
Renner teaches a vaporizer inhaler device involving a supply channel formed via a vaporizer film (see abstract and Fig. 1), in which the vaporizer film may be a polyimide film (see ¶[0079]) and the supply channel may be formed by laser cutting the film, folding over the film, and securing the film in place (see ¶[0045]-[0052]; Fig. 1).
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 laser manufacture modality of Renner for the pocket manufacture modality of copending claims 13, 16-17, and 21 because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) copending claims 13, 16-17, and 21 require a manufacture modality and Renner teaches one such modality.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Chiang C-H., et al., (“Flexible, high-resolution thin-film electrodes for human and animal neural research,” Journal of Neural Engineering, 17 June 2021, Vol. 18, No. 4, 17 pages – cited by Applicant), hereinafter Chiang.
Regarding Claim 1, Chiang teaches the development, validation, and dissemination of flexible, high-resolution, thin-film (TF) electrodes for recording neural activity in animals and humans (see abstract; Figs. 1 and 7D-7E). Chiang teaches a neural interface for implantation against a surface of a brain of a subject (see abstract; Figs. 1 and 7D-7E), the neural interface comprising:
a flexible substrate (§ 2 Material and methods, § 2.1.1 LCP material, and § 2.1.2. Array design, ¶1-3, the LCP substrate electrodes using FPC, such as with the FPC material polyimide; Figs. 1-2) configured to reside on a target region of a cortical surface of the brain (§2.6.2. Recording system for DBS experiments, the LCP electrode array advanced along the cortical surface; Figs. 7A-7E; see also § 1. Introduction ¶2 and § 2.6.1. Recording system for open craniotomy experiments, the electrodes are designed for usage on a cortical surface; Figs. 6A-6E);
a microelectrode array disposed on the flexible substrate (§ 2.1.2. Array design and (§2.6.2. Recording system for DBS experiments, the 128 channel LCP-TF electrode array; Fig. 7E),
the microelectrode array defining a neural interface surface (§2.6.2. Recording system for DBS experiments, the LCP electrode array advanced along the cortical surface; Figs. 7A-7E; see also § 1. Introduction, ¶2 and § 2.6.1. Recording system for open craniotomy experiments, the electrodes are designed for usage on a cortical surface; Figs. 6A-6E; see further § 4. Discussion, ¶4, the electrodes provide a high resolution neural interface),
wherein the microelectrode array comprises electrodes that do not penetrate the cortical surface of the brain against which the electrodes are positioned (§ 4. Discussion, ¶7, the disclosed platform (i.e., LCP-TF electrode array) may be adapted for patients with sensory and motor deficits treated with penetrating microelectrodes, indicating that the present electrodes are non-penetrating; see also § 2.1.2. Array design and Figs. 2A-2C, the electrode contacts shown are non-penetrating, in which contacts are flush or slightly protruded from the LCP substrate); and
a pocket that receives an insertion paddle and is formed on an opposing side of the neural interface surface (§ 2.6.2. Recording system for DBS experiments, the extra silicone pocket on the opposing side (see the ruler marks, which is on the backside as shown in Fig. 7E, as the same as the pocket as shown in 7D), to hold a malleable brain retractor device (R8960, T. Fukushima Brain Spatulas, Integra), which is flat, so would be considered a paddle; Fig. 7D-7E),
wherein the insertion paddle is configured to enter and guide the flexible substrate through a slit in the patient’s skull and an adjacent dural incision and into a subdural space of the subject to reside on the target region (§ 2.6.2. Recording system for DBS experiments, the malleable brain retractor to guide the LCP-TF electrode array through a burr hole and advanced more than 80 mm away from the burr hole to the target cite along the cortical surface; Figs. 7A-7E).
Here, Chiang teaches that the LCP-TF electrode array is implanted via a burr hole, not specifically a slit. However, as Chiang teaches the structure of the device as required by claim 1, and the burr hole’s and LCP-TF electrode array’s small size, that the LCP-TF electrode array as taught by Chaing would be capable of being implanted through a slit rather than the burr hole. Further, there are no specific sizing or other requirements in the claim positively recited for the slit. Therefore, the requirements of the claim are taught by Chiang.
Regarding Claim 2, Chiang teaches the device of claim 1 as stated above. Chiang further teaches the electrodes have a size of 20–200 µm (§ 2.1.2. Array design, ¶4, the gold wires, used as the electrode contacts, have widths ranging from 30-60 µm; Fig. 2C; see also Fig. 1, contact size of 0.2-0.23 mm).
The 30-60 µm range of Chiang suggests the range of the present claim because 20–200 µm overlaps with the range of 30-60 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 3, Chiang teaches the device of claim 1 as stated above. Chiang further teaches the electrodes of the microelectrode array are distributed uniformly (§ 2.2. Molding, the contact spacing is uniform; see also Figs. 7E and 9C, uniform spacing of electrodes shown).
Regarding Claim 4, Chiang teaches the device of claim 1 as stated above. Chiang further teaches that an intra-electrode spacing of the electrodes is less than 400 µm (§ 2.1.2. Array design, ¶4, the gold wires, used as the electrode contacts, have spacing ranging from 30-40 µm; Fig. 2C).
The 30-40 µm range of Chiang suggests the range of the present claim because less than 400 µm overlaps with the range of 30-40 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 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 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Chiang in view of Wijesundara et al. (US Patent Application Publication 2020/0078586 – cited in prior action), hereinafter Wijesundara, and in view of Renner et al. (US Patent Application Publication 2023/0320417 – cited in prior action), hereinafter Renner.
Regarding Claim 13, Chiang teaches the development, validation, and dissemination of flexible, high-resolution, thin-film (TF) electrodes for recording neural activity in animals and humans (see abstract; Figs. 1 and 7D-7E). Chiang teaches a neural interface for implantation against a surface of a brain of a subject (see abstract; Figs. 1 and 7D-7E), the neural interface comprising:
a flexible substrate (§ 2 Material and methods, § 2.1.1 LCP material, and § 2.1.2. Array design, ¶1-3, the LCP substrate electrodes using FPC, such as with the FPC material polyimide; Figs. 1-2) configured to reside on a target region of a cortical surface of the brain (§2.6.2. Recording system for DBS experiments, the LCP electrode array advanced along the cortical surface; Figs. 7A-7E; see also § 1. Introduction ¶2 and § 2.6.1. Recording system for open craniotomy experiments, the electrodes are designed for usage on a cortical surface; Figs. 6A-6E);
a microelectrode array disposed on the flexible substrate (§ 2.1.2. Array design and (§2.6.2. Recording system for DBS experiments, the 128 channel LCP-TF electrode array; Fig. 7E),
the microelectrode array defining a neural interface surface (§2.6.2. Recording system for DBS experiments, the LCP electrode array advanced along the cortical surface; Figs. 7A-7E; see also § 1. Introduction, ¶2 and § 2.6.1. Recording system for open craniotomy experiments, the electrodes are designed for usage on a cortical surface; Figs. 6A-6E; see further § 4. Discussion, ¶4, the electrodes provide a high resolution neural interface),
wherein the microelectrode array comprises electrodes that do not penetrate the cortical surface of the brain against which the electrodes are positioned (§ 4. Discussion, ¶7, the disclosed platform (i.e., LCP-TF electrode array) may be adapted for patients with sensory and motor deficits treated with penetrating microelectrodes, indicating that the present electrodes are non-penetrating; see also § 2.1.2. Array design and Figs. 2A-2C, the electrode contacts shown are non-penetrating, in which contacts are flush or slightly protruded from the LCP substrate); and
a pocket that receives an insertion paddle and is formed on an opposing side of the neural interface surface (§ 2.6.2. Recording system for DBS experiments, the extra silicone pocket on the opposing side (see the ruler marks, which is on the backside as shown in Fig. 7E, as the same as the pocket as shown in 7D), to hold a malleable brain retractor device (R8960, T. Fukushima Brain Spatulas, Integra), which is flat, so would be considered a paddle; Fig. 7D-7E),
wherein the insertion paddle is configured to enter and guide the flexible substrate through a slit in the patient’s skull and an adjacent dural incision and into a subdural space of the subject to reside on the target region (§ 2.6.2. Recording system for DBS experiments, the malleable brain retractor to guide the LCP-TF electrode array through a burr hole and advanced more than 80 mm away from the burr hole to the target cite along the cortical surface; Figs. 7A-7E).
Chiang teaches that the pocket is silicone molded (see § 2.6.2. Recording system for DBS experiments), but not specifically that the pocket is polyimide attached via adhesive or aligned with alignment holes.
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 polyimide and adhesive of Wijesundara as the material for the pocket and attachment of the pocket 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) polyimide films are generally stable and electrically insulated (for example see UBE Corporation pg. 2-4, “What are polyimides?”, UBE Corporation, accessed on 09/19/2025, accessed at https://www.ube.com/ube/en/contents/chemical/polyimide/polyimide_column.html); and/or (3) Chiang requires a material for the pocket and Wijesundara teaches one such alternative material; and/or (4) adhesive is a cheap and easy to utilize modality for attachment known in the industry; and/or (5) Chiang requires a modality of pocket attachment and Wijesundara teaches one such modality.
The modified Chiang does not specifically teach how the polyimide film pocket is manufactured.
Renner teaches a vaporizer inhaler device involving a supply channel formed via a vaporizer film (see abstract and Fig. 1), in which the vaporizer film may be a polyimide film (see ¶[0079]) and the supply channel may be formed by laser cutting the film, folding over the film, and securing the film in place (see ¶[0045]-[0052]; Fig. 1).
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 laser manufacture modality of Renner for the pocket manufacture modality of the modified Chiang 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 modified Chiang requires a manufacture modality and Renner teaches one such modality.
Regarding Claim 14, Chiang in view of Wijesundara and Renner teaches the method of claim 13 as stated above. Chiang further teaches the neural interface comprises the flexible substrate (§ 2 Material and methods, § 2.1.1 LCP material, and § 2.1.2. Array design, ¶1-3, the LCP substrate electrodes using FPC, such as with the FPC material polyimide; Figs. 1-2) configured to reside on a target region of a cortical surface of the brain (§2.6.2. Recording system for DBS experiments, the LCP electrode array advanced along the cortical surface; Figs. 7A-7E; see also § 1. Introduction ¶2 and § 2.6.1. Recording system for open craniotomy experiments, the electrodes are designed for usage on a cortical surface; Figs. 6A-6E);
the microelectrode array disposed on the flexible substrate (§ 2.1.2. Array design and (§2.6.2. Recording system for DBS experiments, the 128 channel LCP-TF electrode array; Fig. 7E),
the microelectrode array defining a neural interface surface (§2.6.2. Recording system for DBS experiments, the LCP electrode array advanced along the cortical surface; Figs. 7A-7E; see also § 1. Introduction, ¶2 and § 2.6.1. Recording system for open craniotomy experiments, the electrodes are designed for usage on a cortical surface; Figs. 6A-6E; see further § 4. Discussion, ¶4, the electrodes provide a high resolution neural interface),
wherein the microelectrode array comprises electrodes that do not penetrate the cortical surface of the brain against which the electrodes are positioned (§ 4. Discussion, ¶7, the disclosed platform (i.e., LCP-TF electrode array) may be adapted for patients with sensory and motor deficits treated with penetrating microelectrodes, indicating that the present electrodes are non-penetrating; see also § 2.1.2. Array design and Figs. 2A-2C, the electrode contacts shown are non-penetrating, in which contacts are flush or slightly protruded from the LCP substrate); and
the respective pocket that receives an insertion paddle and is formed on an opposing side of the neural interface surface (§ 2.6.2. Recording system for DBS experiments, the extra silicone pocket on the opposing side (see the ruler marks, which is on the backside as shown in Fig. 7E, as the same as the pocket as shown in 7D), to hold a malleable brain retractor device (R8960, T. Fukushima Brain Spatulas, Integra), which is flat, so would be considered a paddle; Fig. 7D-7E),
wherein the insertion paddle is configured to enter and guide the flexible substrate through a slit in the patient’s skull and an adjacent dural incision and into a subdural space of the subject to reside on the target region (§ 2.6.2. Recording system for DBS experiments, the malleable brain retractor to guide the LCP-TF electrode array through a burr hole and advanced more than 80 mm away from the burr hole to the target cite along the cortical surface; Figs. 7A-7E).
Here, the modified Chiang teaches that the LCP-TF electrode array is implanted via a burr hole, not specifically a slit. However, as the modified Chiang teaches the structure of the device as required by claim 14, and the burr hole’s and LCP-TF electrode array’s small size, that the LCP-TF electrode array as taught by the modified Chaing would be capable of being implanted through a slit rather than the burr hole. Further, there are no specific sizing or other requirements in the claim positively recited for the slit. Therefore, the requirements of the claim are taught by the modified Chiang.
Regarding Claim 15, Chiang in view of Wijesundara and Renner teaches the method of claim 14 as stated above. Chiang further teaches the electrodes have a size of 20–200 µm (§ 2.1.2. Array design, ¶4, the gold wires, used as the electrode contacts, have widths ranging from 30-60 µm; Fig. 2C; see also Fig. 1, contact size of 0.2-0.23 mm).
The 30-60 µm range of the modified Chiang suggests the range of the present claim because 20–200 µm overlaps with the range of 30-60 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 16, Chiang in view of Wijesundara and Renner teaches the method of claim 14 as stated above. Chiang further teaches the electrodes of the microelectrode array are distributed uniformly (§ 2.2. Molding, the contact spacing is uniform; see also Figs. 7E and 9C, uniform spacing of electrodes shown).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kipke et al. (US Patent Application Publication 2013/0144362 – cited by Applicant), hereinafter Kipke, in view of Pianca et al. (US Patent Application Publication 2014/0100586 – cited by Applicant), hereinafter Pianca, and in view of Wijesundara, and in view of Renner.
Regarding Claim 13, 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 implantation against a surface of a brain (see abstract, ¶[0002]-[0003], and ¶[0024] modular electrode array of the neural device is intended for use with the surface of the brain), 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);
a microelectrode array disposed on a flexible substrate (¶[0015]-[0021] the electrode arrays, each array comprising multiple electrodes, ¶[0030] the modules may be coupled together via fasteners; Figs. 1-2 and 4),
the microelectrode array defining a neural interface surface (¶[0030] the modules may be coupled together via fasteners; Figs. 1-2 and 4),
the microelectrode array comprises electrodes that do not penetrate the surface of the brain against which the electrodes are positioned (¶[0018] the electrode modules may include penetrating electrodes in some embodiments, indicating that the standard microelectrodes do not penetrate).
Kipke is silent regarding a pocket that receives an insertion stylet and is formed on an opposing side of the neural interface surface.
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). 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 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 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 pocket is polyimide attached via adhesive or aligned with alignment holes.
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 polyimide and adhesive of Wijesundara as the material for the pocket and attachment of the pocket 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) polyimide films are generally stable and electrically insulated (for example see UBE Corporation pg. 2-4, “What are polyimides?”, UBE Corporation, accessed on 09/19/2025, accessed at https://www.ube.com/ube/en/contents/chemical/polyimide/polyimide_column.html); and/or (3) the modified Kipke requires a material for the pocket and Wijesundara teaches one such material; and/or (4) adhesive is a cheap and easy to utilize modality for attachment known in the industry; and/or (5) the modified Kipke requires a modality of pocket attachment and Wijesundara teaches one such modality.
The modified Kipke does not specifically teach how the polyimide film pocket is manufactured.
Renner teaches a vaporizer inhaler device involving a supply channel formed via a vaporizer film (see abstract and Fig. 1), in which the vaporizer film may be a polyimide film (see ¶[0079]) and the supply channel may be formed by laser cutting the film, folding over the film, and securing the film in place (see ¶[0045]-[0052]; Fig. 1).
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 laser manufacture modality of Renner for the pocket manufacture modality 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) the modified Kipke requires a manufacture modality and Renner teaches one such modality.
Response to Arguments
Applicant’s arguments, drawings
Applicant’s arguments, see pg. 8-9, filed December 29, 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, objections
Applicant’s arguments, see pg. 8, filed December 29, 2026, with respect to the objections of claims 3 and 14 have been fully considered and are persuasive. Therefore, the objections have been withdrawn. However, upon further consideration, new objections are made that were necessitated by Applicant’s amendment filed on December 29, 2026.
Applicant’s arguments, 35 U.S.C. § 112(a)
Applicant’s arguments, see pg. 9, filed December 29, 2026, with respect to the rejections of claims 17-18 under 35 U.S.C. § 112(a) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
Applicant’s arguments, 35 U.S.C. § 112(b)
Applicant’s arguments, see pg. 9, filed December 29, 2026, with respect to the rejections of claims 1-4 and 13-18 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 December 29, 2026.
Applicant’s arguments, 35 U.S.C. § 103
Applicant’s arguments, see pg. 10-15, filed December 29, 2026, with respect to the rejections of claims 1-4 and 14-18 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 Chiang C-H., et al., (“Flexible, high-resolution thin-film electrodes for human and animal neural research,” Journal of Neural Engineering, 17 June 2021, Vol. 18, No. 4, 17 pages).
Applicant’s arguments, see pg. 13-14, filed December 29, 2026, with respect to the rejections of claim 13 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).
The Applicant argues that Wijesundara does not teach or suggest anything being lasercut, especially not a pocket area from adhesive-backed polyimide film; moreover, no pockets are formed by folding any components. The examiner respectfully disagrees. Wijesundara was not used to teach such elements. Rather, Renner was used to teach such elements, in combination with the other references. Therefore, Applicant’s arguments are not persuasive.
The Applicant next argues that Wijesundara does not teach aligning the fabricated pocket with one or more alignment holes of the distal end of a microelectrode array of the one or more microelectrode arrays. The examiner respectfully disagrees. 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Negi et al. (US Patent 10,058,263) teaches technology for a neural interface, including an intracranial electrode grid operable to detect neural activity (see abstract and Fig. 1C), in which a single connecting wire (pigtail) may be utilized, thus allowing a reduction in size of the implant incision (see col. 7 ln. 60 – col. 8 ln. 10).
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/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791