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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/22/2026 has been entered.
Response to Amendment
3. This action is responsive to the amendments filed 6/22/2026. Claim 1 has been amended. Claim 11 was canceled and claim 19 was newly added.
Response to Arguments
Applicant’s response with respect to art rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL. —The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 19 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, claim 19 recites the limitation of “wherein the cylindrical body of the rod-shaped electrode device is formed by folding a two-dimensional substrate into a cylindrical shape such that opposite ends of the two-dimensional substrate are joined to one another without overlap”. Applicant relies upon on Fig. 1 of the drawings for support. However, as noted in paragraph [0080] of Applicant’s specification, Fig. 1 is merely a perspective view of a schematic embodiment of an electrode module. This limitation does not appear in the originally filed specification, claims, or drawings. In fact, neither the drawings nor the specifications provides support on how the electrode device is made/manufactured. Examiner further notes that the term “folding” does not appear in the specification.
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, 3-7, 9-10, 12, and 16-18 are rejected under 35 U.S.C 103 as being unpatentable over Dirk et al. (US Patent No.: 9,555,583 – Previously Cited) and further in view of Rogers et al. (US Pub.: 2011/0230747 A1 – Previously Cited) and further in view of Litt et al. (US Pub.: 2015/0305625 A1).
Regarding claim 1, Dirk teaches an electrode device for a neurostimulation system (e.g. column 8, lines 23-26, – neural interface both records and stimulate neural activity), comprising a substrate (e.g. Fig. 1B – polymer mat 11; column 8 lines 13-17)
and at least one electrode (e.g. Fig. 1B – electrode site 15; column 8 lines 19-21)
wherein the at least one electrode is arranged within the substrate (e.g. Fig. 1B – polymer mat 11, electrode site 15; column 7 lines 30-34).
However, Dirk does not explicitly teach wherein a portion of the substrate comprises a mesh, and wherein the electrode device is a rod-shaped electrode device comprising a cylindrical body.
Rogers, in a same field of endeavor of implantable medical devices, discloses wherein a portion of the substrate (e.g. Fig. 5B – 100(5)) comprises a mesh (e.g. Fig. 5B – layer 510; paragraphs 0036; 0129).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrode device of Dirk to have a portion of the substrate comprise a mesh, as taught and suggested by Rogers, in order to allow for more efficient handling and administration of the implantable device, while at the same time providing mechanical properties (e.g., flexibility, deformability, bendability, etc.) useful for establishing conformal contact with the target tissue (Rogers, paragraph 0036).
However, Dirk in view of Rogers does not explicitly teach wherein the electrode device is a rod-shaped electrode device comprising a cylindrical body.
Litt, in a same field of endeavor of implantable medical devices, discloses wherein the electrode device is a rod-shaped electrode device comprising a cylindrical body (e.g. paragraph 0080).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Dirk and Rogers to have the electrode device be rod-shaped comprising a cylindrical body, as taught and suggested by Litt, because it allows for the electrode device to be implanted in deeper brain structures and increases the spatial sampling that can be performed by the device (Litt, paragraph 0080).
Regarding claim 3, Dirk in view of Rogers in view of Litt teaches the electrode device according to claim 1 as discussed above, and Rogers further teaches wherein the mesh-like structure of the substrate comprises multiple voids of different sizes (e.g. paragraphs 0129; 0182), of different sizes (e.g. column 5, lines 6-11), wherein the device is configured for nerve stimulation and/or cortical stimulation and/or deep brain stimulation (e.g. paragraph 0045).
Regarding claim 4, Dirk in view of Rogers in view of Litt teaches the electrode device according to claim 3 as discussed above, and Dirk further teaches wherein the voids comprise at least two different sizes of void, wherein each size is within the range of 10 mm to 0.1 µm (e.g. column 4, lines 54-67, column 3, lines 57-58, – the pores can have differing dimensions (e.g. diameter, length, width, etc).
Regarding claim 5, Dirk in view of Rogers in view of Litt teaches the electrode device
according to claim 3 as discussed above, and Rogers further teaches wherein the voids are symmetrically distributed along a cross-section of the substrate, in order to provide isotropic properties of the electrode device (e.g. Fig. 5b; paragraphs 0129-0130).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Dirk, Rogers, and Litt to have the voids symmetrically distributed along a cross-section of the substrate, as taught and suggested by Rogers, in order to provide the predictable results of easier manufacturing of the device as it allows for easier quality control (i.e. visual inspecting that the voids on the substrate are symmetrical). Additionally, it would have been obvious to try the symmetrical distribution choosing from a finite number of identified and predictable void arrangements with a reasonable expectation of success of more uniform electrical stimulation when in use.
Regarding claim 6, Dirk in view of Rogers in view of Litt teaches the electrode device according to claim 3 as discussed above, and Dirk further teaches wherein the voids of the substrate comprise a circular shape, a triangular shape, a hexagonal shape, an octagonal shape, a rectangular shape, a parallelogram shape, and/or a squared shape (e.g. Fig. 1B – neural openings 12, – circular shape; column 8 lines 16-19).
Regarding claim 7, Dirk in view of Rogers in view of Litt teaches the electrode device according to claim 1 as discussed above, and Dirk further teaches wherein the electrode device comprises at least one stimulation electrode and multiple recording electrodes (e.g. column 8, lines 22-25; column 10, lines 20-21).
Regarding claim 9, Dirk in view of Rogers in view of Litt teaches the electrode device according to claim 1 as discussed above, and Dirk further teaches wherein the electrode device comprises multiple conductive connection elements, being positioned in and/or on the substrate for connecting each electrode with the conductive connector (e.g. Fig. 1B – electrical connectors 16; column 7 lines 65-66; column 8, lines 20-23).
Regarding claim 10, Dirk in view of Rogers in view of Litt teaches the electrode device according to claim 9 as discussed above, and Rogers further teaches wherein each of the conductive connection elements are arranged along the voids of the substrate in a straight line between the voids, such that a connection angle between the conductive connection element and the conductive connector is the same for all conductive connection elements of the electrode device (e.g. paragraphs 0126, 0129).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Dirk, Rogers, and Litt to incorporate having each of the conductive connection elements are arranged along the voids of the substrate in a straight line between the voids, such that a connection angle between the conductive connection element and the conductive connector is the same for all conductive connection elements of the electrode device, as taught and suggested by Rogers, for the purpose of improving the flexibility of the device (Rogers, paragraph 0126).
Regarding claim 12, Dirk in view of Rogers in view of Litt teaches the electrode device for a neurostimulation system, comprising a substrate and at least one electrode, wherein the at least one electrode is arranged within the substrate, wherein a portion of the substrate comprises a mesh, and wherein the electrode device is a rod-shaped electrode device comprising a cylindrical body (see rejection of claim 1 above). Additionally, Dirk further teaches an electrode module for a neurostimulation system comprising at least one electrode device (e.g. Fig. 1B; column 8 lines 13-20).
Regarding claim 16, Dirk in view of Rogers in view of Litt teaches the electrode module according to claim 12 as discussed above, and Dirk further teaches wherein the electrode module comprises at least one sensor device being arranged at and/or along a void of the at least one electrode device such that the nervous tissue can be observed via the void by the sensor device (e.g. column 8, lines 19-27).
Regarding claim 17, Dirk in view of Rogers in view of Litt teaches the electrode device for a neurostimulation system, comprising a substrate and at least one electrode, wherein the at least one electrode is arranged within the substrate, wherein a portion of the substrate comprises a mesh, and wherein the electrode device is a rod-shaped electrode device comprising a cylindrical body (see rejection of claim 1 above). Additionally, Dirk further teaches a neurostimulation system for nerve stimulation and/or cortical stimulation and/or deep brain stimulation (e.g. column 8 lines 19-25).
Regarding claim 18, Dirk in view of Rogers in view of Litt teaches the electrode device for a neurostimulation system, comprising a substrate and at least one electrode, wherein the at least one electrode is arranged within the substrate, wherein a portion of the substrate comprises a mesh, and wherein the electrode device is a rod-shaped electrode device comprising a cylindrical body (see rejection of claim 1 above). Additionally, Dirk further teaches a method for manufacturing an electrode device and/or an electrode module and/or a neurostimulation system (e.g. column 10 lines 40-47).
9. Claim 2 is rejected under 35 U.S.C 103 as being unpatentable over Dirk and further in view of Rogers and further in view of Litt and further in view of Lu et al. (NPL reference, “Flexible Neural Electrode Array Based-on Porous Graphene for Cortical Microstimulation and Sensing”, published September, 2016 – Previously Cited).
Regarding claim 2, Dirk in view of Rogers in view of Litt teaches the electrode device according to claim 1 as discussed above. However, Dirk in view of Rogers in view of Litt does not explicitly teach that the at least one electrode comprises graphene. Lu, in a same field of endeavor of electrical stimulation, discloses at least one electrode comprising graphene (e.g. pg. 2).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Dirk, Rogers, and Litt to incorporate at least one electrode comprising graphene, as taught and suggested by Lu, in order to improve/enhance the conductivity, biocompatibility, and flexibility of the electrode (Lu, page 2).
Claim 8 is rejected under 35 U.S.C 103 as being unpatentable over Dirk and further in view of Rogers and further in view of Litt and further in view of Wu et al. (US Pub.: 2022/0225921 A1 – Previously Cited).
Regarding claim 8, Dirk in view of Rogers in view of Litt teaches the electrode device
according to claim 1 as discussed above, and Dirk further teaches wherein the electrode device comprises at least one conductive connector, being situated along at least a part of the outer circumference of the electrode device (e.g. Fig. 1B; column 7 lines 65-66; column 8, lines 20-23).
However, Dirk in view of Rogers in view of Litt does not explicitly teach that at least one conductive connector comprises gold.
Wu, in a same field of endeavor of implantable medical devices, discloses at least one conductive connector comprising gold (e.g. paragraph 0059, – the electrode points, connection lines, and connection points can all comprise gold).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Dirk, Rogers, and Litt to incorporate at least one conductive connector comprising gold, as taught and suggested by Wu, in order to improve/enhance the electrical conductivity, biocompatibility, and corrosion resistance of the electrode device.
11. Claim 13 is rejected under 35 U.S.C 103 as being unpatentable over Dirk and further in view of Rogers and further in view of Litt and further in view of Hauptmann et al. (US Pub.: 2022/0072313 A1 – Previously Cited).
Regarding claim 13, Dirk in view of Rogers in view of Litt teaches the electrode module according to claim 12 as discussed above. However, Dirk in view of Rogers in view of Litt does not explicitly teach wherein multiple electrode devices are arranged side by side, wherein the multiple electrode devices each comprises a conductive connector, wherein the conductive connectors are combined in order to form a conductive connection expanding along and/or between the different electrode devices.
Hauptmann, in a same field of endeavor of electrical stimulation devices, discloses multiple electrode devices arranged side by side, wherein the multiple electrode devices each comprises a conductive connector, wherein the conductive connectors are combined in order to form a conductive connection expanding along and/or between the different electrode devices (e.g. paragraph 0052).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Dirk, Rogers, and Litt to include having multiple electrode devices arranged side by side, wherein the multiple electrode devices each comprises a conductive connector, wherein the conductive connectors are combined in order to form a conductive connection expanding along and/or between the different electrode devices, as taught and suggested by Hauptmann, in order to provide the predictable results of the physician being able to more easily provide electrical stimulation to two different areas/targets of the brain of the brain of the patient simultaneously.
12. Claims 14-15 are rejected under 35 U.S.C 103 as being unpatentable over Dirk and further in view of Rogers and further in view of Litt and further in view of Hauptmann and further in view of Page et al. (US Pub.: 2020/0269046 A1 – Previously Cited).
Regarding claim 14, Dirk in view of Rogers in view of Litt teaches the electrode module according to claim 12 as discussed above. However, Dirk in view of Rogers in view of Litt does not explicitly teach wherein the electrode module comprises at least two electrode devices.
Hauptmann, in a same field of endeavor of electrical stimulation devices, discloses wherein the electrode module comprises at least two electrode devices (e.g. paragraph 0052).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Dirk, Rogers, and Litt to include having at least two electrode devices, as taught and suggested by Hauptmann, in order to provide the predictable results of the physician being able to more easily provide electrical stimulation to two different areas of the brain of the patient simultaneously.
However, Dirk in view of Rogers in view of Litt in view of Hauptmann does not explicitly teach wherein a second electrode device is concentrically arranged at a longitudinal end of a first electrode device such that a multi-layer arrangement of electrode devices is provided.
Page, in a same field endeavor of electrical stimulation devices, discloses wherein a second electrode device is concentrically arranged at a longitudinal end of a first electrode device such that a multi-layer arrangement of electrode devices is provided (e.g. paragraph 0240).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Dirk, Rogers, Litt, and Hauptmann to incorporate a second electrode device being concentrically arranged at a longitudinal end of a first electrode device, as taught and suggested by Page, in order to maximize and direct the electric field and flow of current into the target nervous structure and without unwanted stimulation of nearby tissue (Page, paragraph 0240).
Regarding claim 15, Dirk in view of Rogers in view of Litt in view of Hauptmann in view of Page teaches the electrode module according to claim 14 as discussed above, and Page further teaches wherein the at least one of the second electrode device is concentrically arranged with a void of the mesh-like structure of the first electrode device (Page, paragraph 0240).
Claim 19 is rejected under 35 U.S.C 103 as being unpatentable over Dirk and further in view of Rogers and further in view of Litt and further in view of van der Puije (US Patent No.: 4,762,135, hereafter referred to as “Puije”).
Regarding claim 19, Dirk in view of Rogers in view of Litt teaches the electrode device according to claim 1 as discussed above. With regards to the limitation of wherein the cylindrical body of the rod-shaped electrode device is formed by folding a two-dimensional substrate into a cylindrical shape such that opposite ends of the two-dimensional substrate are joined to one another without overlap, rolling a 2-D planar object to make a cylinder is a known and obvious technique as taught by Puije (see column 9, lines 5-8). It would have been obvious to use a known technique of fabricating a cylindrical object out of a flat sheet, as taught and suggested by Puije. One would manufacture the cylinder without overlapping as to keep the thickness uniform and not waste material. Additionally, the Examiner notes that this a product-by-process limitation and that the patentability of a product does not depend on its method of production (see MPEP 2113).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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