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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/27/2024, 04/11/2025 and 07/18/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
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.
Claims 1-5, 7-9, 13-16, and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Zhejun et al (“A Flexible and Stretchable Kirigami-Inspired Implantable Neural Probe with Floating Microsites for Electrophysiology Recordings”) herein referred to as “Zhejun” in view of Tabib-Azar (US20160128589A1) herein referred to as “Tabib-Azar”.
Regarding claim 1, An implantable stretchable flexible neural electrode, ([Abstract] implantable stretchable and flexible neural probe which is seen as a neural electrode) comprising an electrode wire ([page 2: paragraph 2 under “Probe Fabrication”] contains a metal wire which is seen as the electrode wire) and a flexible insulating part wrapping the electrode wire, ([page 2: paragraph 2 under “Probe Fabrication”] an insulation layer, which is made from polyimide, which is seen as being flexible, forms the top layer, which is seen as wrapping the electrode wire) an electrode site and an auxiliary implantation structure are provided (See FIG 1B where the floating electrode points is seen as the electrode site and the hole is seen as an auxiliary implantation structure); the electrode site is electrically connected to the electrode wire and exposed from the flexible insulating part; ([page 2: paragraph 2 under “Probe Fabrication”] the electrode sites are exposed from the insulation layer) and the auxiliary implantation structure is configured to drive the structure to stretch under an action of external force (See FIG 7C where a steel needle which is seen as applying an external force, causes the structure to stretch when being implanted, which is seen as being driven) however, Zhejun does not explicitly disclose the spiral configuration of the structure.
Tabib-Azar discloses: the spiral configuration of the structure (See FIG 1B which discloses a spiral configuration of the electrode structure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the configuration as disclosed in Zhejun to include a spiral configuration as disclosed in Tabib-Azar. The motivation being that having a spiral structure allows for improved implantation (Tabib-Azar [0058])
Regarding claim 2, Zhejun in view of Tabib-Azar discloses: The implantable stretchable flexible neural electrode according to claim 1, wherein the spiral structure is configured to be stretchable in any direction (Zhejun [page 2: under “Tensile characteristics of the probe”] the structure can be stretched to various degrees of freedom in the longitudinal direction, which is seen as being stretchable in any direction).
Regarding claim 3, Zhejun in view of Tabib-Azar discloses: The implantable stretchable flexible neural electrode according to claim 1, wherein the spiral structure comprises a plurality of circles, wherein any two adjacent circles among the plurality of circles are an inner circle and an outer circle, respectively, the outer circle surrounds the inner circle, and a termination end of the outer circle is connected to an initial end of the inner circle (Zhejun [See FIG 1A] where there is a plurality of circles, [See FIG 1B] where there is a hole which is seen as two adjacent circles, having an inner circle and an outer circle where the ends are connected).
Regarding claim 4, Zhejun in view of Tabib-Azar discloses: The implantable stretchable flexible neural electrode according to claim 3, wherein the auxiliary implantation structure is provided at an innermost circle among the plurality of circles (Zhejun [See FIG 1B] where the hole is seen as the auxiliary implantation structure, which is seen as the inner most circle of the hole).
Regarding claim 5, Zhejun in view of Tabib-Azar discloses: The implantable stretchable flexible neural electrode according to claim 4, wherein the flexible insulating part is provided with a protruding part extending beyond the electrode wire, (Zhejun See annotated FIG 1B below showing the protruding part. It does not contain any electrode floating points which is seen as being beyond the electrode wire) and the auxiliary implantation structure is a through hole, a groove or a protrusion provided at the protruding part (Zhejun [See FIG 1B] where the hole which is seen as the auxiliary part is a through hole).
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Regarding claim 7, Zhejun in view of Tabib-Azar discloses: The implantable stretchable flexible neural electrode according to claim 3, wherein each of the plurality of circles comprises a plurality of curved portions connected in sequence (Zhejun See annotated FIG 1A below where the plurality of circles comprises a plurality of curved portions in sequence).
Regarding claim 8, Zhejun discloses: The implantable stretchable flexible neural electrode according to claim 1, further comprising a linear structure of the electrode wire and the flexible insulating part, however, Zhejun does not explicitly disclose: wherein the linear structure is connected to the spiral structure.
Tabib-Azar discloses: wherein the linear structure is connected to the spiral structure (See FIG 1B where the antenna part 160, is seen as the linear structure which is connected to the spiral structure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the structure as disclosed in Zhejun to include a linear structure connected to the spiral structure as disclosed in Tabib-Azar. The motivation being that having a linear structure connected the spiral structure can make implantation of more efficient (Tabib-Azar [0058]).
Regarding claim 9, Zhejun in view of Tabib-Azar discloses: The implantable stretchable flexible neural electrode according to claim 8, wherein the linear structure comprises an auxiliary electrode wire wrapped by the flexible insulating part; and in the linear structure, the auxiliary electrode wire is electrically connected to the electrode wire (Zhejun See FIG 1C where the bonding pad is seen as the auxiliary electrode wire as it is seen to lengthen the electrode therefore providing more flexibility).
Regarding claim 13, Zhejun in view of Tabib-Azar discloses: The implantable stretchable flexible neural electrode according to claim 1, wherein a material of the electrode wire and a material of the electrode site comprise at least one of gold, platinum and iridium; (Zhejun [page 2: paragraph 2 under “probe fabrication”] the floating electrode sites are formed from gold) and a material of the flexible insulating part comprises at least one of polyimide, parylene and SU-8 photoresist (Zhejun [page 1: under “Introduction” paragraph 2] the flexible insulating structure is made from polyimide).
Regarding claim 14, Zhejun in view of Tabib-Azar discloses: The implantable stretchable flexible neural electrode according to claim 1, further comprising an adhesive layer provided between the electrode wire and the flexible insulating part (Zhejun [page 2: paragraph 2 under “probe fabrication”] Chromium, which is seen as the adhesive layer is provided between the flexible insulating part PI and the electrode wire).
Regarding claim 15, Zhejun in view of Tabib-Azar discloses: The implantable stretchable flexible neural electrode according to claim 1, comprising: a plurality of electrode wires wrapped by the flexible insulating part and insulated from each other; (Zhejun [See FIG 2E] where the electrode wires are wrapped in the flexible insulating part and are insulated from each other) and a plurality of electrode sites exposed from the flexible insulating part, electrically connected to the plurality of the electrode wires in one-to-one correspondence, and spatially separated from each other (Zhejun [See FIG 2E] where the floating electrode sites are exposed from the insulating part, and are connected to the plurality of electrical wires which are separated from each other).
Regarding claim 16, Zhejun in view of Tabib-Azar discloses: The implantable stretchable flexible neural electrode according to claim 15, wherein the plurality of electrode wires are located at a same layer; or the plurality of electrode wires are located at a plurality of layers arranged in a stacked manner, and each of the plurality of layers comprises at least one of the plurality of electrode wires (Zhejun [See FIG 2D] where the electrode wires are located on the same layer).
Regarding claim 29, Zhejun in view of Tabib-Azar discloses: A manufacturing method of the implantable stretchable flexible neural electrode according to claim 1, (Zhejun [page 2: under “Probe fabrication”] fabricating the probe is seen as a manufacturing method for the implantable electrode) comprising: providing a base substrate, wherein the base substrate comprises a first region and a second region; (Zhejun [page 2: under “Probe fabrication”] the probe is manufactured having a sandwich structure which is seen as having a base substrate comprising a first region and a second region) forming a first insulating layer on the base substrate; (Zhejun [page 2: under “Probe fabrication”] the PI is seen as the first insulating layer on the base substrate, which is seen as the Al) forming a conductive layer on the first insulating layer and patterning the conductive layer to form the electrode wire and the electrode site in the first region of the base substrate; (Zhejun [page 2: under “Probe fabrication”] the Cr is seen as forming a conductive layer on the first insulating layer and the Au is patterned which is seen as forming the electrode wire and electrode sites) forming a second insulating layer on the electrode wire and the electrode site; (Zhejun [page 2: under “Probe fabrication”] where the photoresist mask which is seen as the second insulating layer is patterned) patterning the first insulating layer and the second insulating layer to form the auxiliary implantation structure and the flexible insulating part wrapping the electrode wire, (Zhejun [FIG 2C] patterning the PI and the photoresist is seen to form the hole which is seen as the auxiliary implantation structure; Zhejun [page 2: paragraph 2 under “Probe fabrication”] a final layer of PI is deposited over the electrode wires which is seen as the flexible insulating part wrapping the electrode wire) and patterning the second insulating layer to expose the electrode site; (Zhejun [page 2: under “Probe fabrication”] The photoresist is patterned to expose the electrode sites) and removing at least a portion of the base substrate located in the first region (Zhejun [See FIG 2B] portion of the base substrate is removed as the slits are formed in the first region).
Regarding claim 30, Zhejun in view of Tabib-Azar discloses: The manufacturing method according to claim 29, further comprising: forming a sacrificial layer at least in the first region of the base substrate before forming the first insulating layer on the base substrate; (Zhejun [page 2: under “Probe fabrication”] a sacrificial layer is formed through Al on the wafer, and PI is deposited which is seen as the first region of the base substrate) and the removing at least a portion of the base substrate located in the first region comprises: removing the sacrificial layer and cutting the base substrate to remove at least a portion of the base substrate located in the first region (Zhejun [page 2: under “Probe fabrication”] the sacrificial layer is removed by evaporation; [FIG 2B] forming slits by cutting the PI is seen as removing portion of the base substrate).
Regarding claim 31, Zhejun in view of Tabib-Azar discloses: The manufacturing method according to claim 29, wherein patterning the conductive layer to form a pad in the second region of the base substrate while forming the electrode wire and the electrode site in the first region of the base substrate, wherein the electrode wire is electrically connected to the pad; (Zhejun [See FIG 2D] where the conductive layer, Cr is patterned to form a pad on the photoresist mask which is seen as the second region and the electrode wire, which is seen as the gold, and the electrode site are in the first region and electrically connected to the pad) and the manufacturing method further comprises: patterning the second insulating layer to expose the pad (Zhejun [See FIG 2C] where the photoresist mask which is seen as the second insulating layer is patterned to expose the Cr which is seen as the pad).
Regarding claim 32, Zhejun in view of Tabib-Azar discloses: An implantation method of the implantable stretchable flexible neural electrode according to claim 1, (Zhejun [page 3: under “Probe implanted in vitro”] a method for implantation of the neural probe) comprising: applying an external force to the auxiliary implantation structure by using an auxiliary implantation instrument to implant at least part of the flexible neural electrode into a target tissue, (Zhejun [page 3: under “Probe implanted in vitro”] the steel needle is seen as the auziliary implantation instrument, which is used to apply a force to the hole, which is seen as the auxiliary implantation structure) and at least partially stretching the spiral structure under a drive of the external force during a process of implanting the at least part of the flexible neural electrode into the target tissue; (Zhejun [See FIG 7C] where the structure is stretched Zhejun [page 3: under “Probe implanted in vitro”] having a speed is seen as having an external force, therefore the structure is driven into the target tissue by an external force) and removing the auxiliary implantation instrument and leaving, in the target issue, the at least part of the flexible neural electrode implanted in the target tissue (Zhejun [page 3: under “Probe implanted in vitro”] the structure is left implanted into the agar, which is seen as the target tissue, and the steel needle which is seen as the auxiliary implantation instrument, is removed).
Claims 10, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhejun in view of Tabib-Azar in further view of Tao et al (CN113616211A) herein referred to as “Tao”
Regarding claim 10, Zhejun in view of Tabib-Azar discloses: The implantable stretchable flexible neural electrode according to claim 1, further comprising an anchoring structure, (See annotated FIG 1B above where the protruding part is seen as an anchoring structure) however, Zhejun in view of Tabib-Azar does not explicitly disclose: wherein an angle is provided between the anchoring structure and the electrode wire, and the anchoring structure is configured to interact with a target tissue after the flexible neural electrode is implanted into the target tissue so as to prevent the flexible neural electrode from moving relative to the target tissue.
Tao discloses: wherein an angle is provided between the anchoring structure and the electrode wire, ([page 5: paragraph 5] the electrode wire is located within the main structure 2, [FIG 4] An angle forms between the anchoring structure which is seen as 3, and the electrode wire which is in the main structure 2) and the anchoring structure is configured to interact with a target tissue after the flexible neural electrode is implanted into the target tissue so as to prevent the flexible neural electrode from moving relative to the target tissue ([page 6: paragraph 17] the anchoring structure unfolds in the tissue which is seen as preventing the electrode from moving).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anchoring structure as disclosed in Zhejun in view of Tabib-Azar to include an angle between the anchoring structure and the electrode wire as disclosed in Tao. The motivation being that having an angle prevents damage to the tissue during the implantation process (Tao [page 6: paragraph 17]).
Regarding claim 11, Zhejun in view of Tabib-Azar discloses: The implantable stretchable flexible neural electrode according to claim 10, however, Zhejun in view of Tabib-Azar does not explicitly disclose: wherein an edge of the anchoring structure extending from the electrode wire in a direction away from the electrode wire is in an arc shape, and the arc shape protrudes towards the auxiliary implantation structure.
Tao discloses: wherein an edge of the anchoring structure extending from the electrode wire in a direction away from the electrode wire is in an arc shape, and the arc shape protrudes towards the auxiliary implantation structure (See FIG 4 where the anchoring structure which is seen as 3, extends away from the electrode wire, which is seen as 2, and forms an arc shape towards the stress structure, 5, which is seen as the auxiliary implantation structure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the neural electrode as disclosed in Zhejun in view of Tabib-Azar to include the anchoring structure extending from the electrode wire in an arc shape as disclosed in Tao. The motivation being that having an arc shape prevents damage to the tissue during the implantation process (Tao [page 6: paragraph 17]).
Regarding claim 12, Zhejun in view of Tabib-Azar discloses: The implantable stretchable flexible neural electrode according to claim 10, however, Zhejun in view of Tabib-Azar does not explicitly disclose: wherein the anchoring structure comprises an anchoring electrode wire covered by the flexible insulating part, and the electrode site is electrically connected to the electrode wire through the anchoring electrode wire.
Tao discloses: wherein the anchoring structure comprises an anchoring electrode wire covered by the flexible insulating part, and the electrode site is electrically connected to the electrode wire through the anchoring electrode wire (See FIG 8 where the anchoring structure which is seen as 5, has an anchoring electrode wire which is seen as 7, which is electrically connected to the electrode site, [page 6: paragraph 4] and covered by a protective layer which is seen as an insulating part).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anchoring structure as disclosed in Zhejun in view of Tabib-Azar to include the electrode site electrically connected to the electrode wire through the anchoring electrode. The motivation being that this can improve detection range (Tao [page 5: paragraph 1]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zhejun in view of Tabib-Azar in further view of Sibary et al (US12397139B1) herein referred to as “Sibary”
Regarding claim 6, Zhejun in view of Tabib-Azar discloses: The implantable stretchable flexible neural electrode according to claim 5, however, Zhejun in view of Tabib-Azar does not explicitly disclose: wherein a position mark is provided on the protruding part.
Sibary discloses: wherein a position mark is provided on the protruding part ([col 12: lines 57-60] the implant electrode contains a marker; See FIG 27 where the marker 2772, is located on the protruding part which is seen as 188).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode as disclosed in Zhejun in view of Tabib-Azar to include a position mark as disclosed in Sibary. The motivation being that this allows the surgeon to ascertain how far the electrode has been inserted (Sibary [col 13: lines 1-4]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M GANAN-SINGH whose telephone number is (571)272-3194. The examiner can normally be reached Monday to Friday 7:30am to 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne M Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.G.S/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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