DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims & Election/Restriction
2. This action is responsive to the Preliminary Amendment filed on 10/30/2024, and the “RESPONSE TO RESTRICTION REQUIREMENT” filed 04/28/2026.
3. Applicant’s election without traverse of Group I (claims 1-21) in the Reply filed on 04/28/2026 is acknowledged. Claims 22-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Claims 1-21 have been examined on the merits.
Drawings
4. FIGURE 1 should be designated by a legend such as --PRIOR ART-- because only that which is old is illustrated. See MPEP § 608.02(g).
5. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
Reference character (70) of “measurement circuit 70” as recited at pg. 11, lines 16-17 of the as-filed Specification does not appear in the drawing figures; &
Reference character (80) of stimulation circuit 80” as recited at pg. 11, lines 17-18 of the as-filed Specification does not appear in the drawing figures.
6. 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. 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
7. Claims 7 & 11 are objected to because of the following informalities:
a. In claim 7, lines 1-3, the recitation of “wherein an insulation layer covering the connection part and an insulation layer covering a portion of the electrode part connected to the connection part are the first insulation layer” should instead recite --wherein the first insulation layer covers the connection part and a portion of the electrode part connected to the connection part-- for conciseness.
b. In claim 11, lines 1-3, the recitation of “wherein an additional insulating layer covering the connection part and an additional insulation layer covering a portion of the electrode part connected to the connection part are the first insulation layer” should instead recite --wherein the first insulation layer covers the connection part and a portion of the electrode part connected to the connection part-- for conciseness.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
8. 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.
9. Claims 1-21 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
10. Claim 1 recites the limitation “a terminal” in line 9. This recitation renders the claim indefinite, as it is not clear whether the recited “a terminal” is intended to be the same “a terminal” previously recited in lines 2-3 of the claim, or a separate/additional “terminal.” As such, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
11. Claims 2-21 are rejected as ultimately depending from a claim (claim 1) rejected under 35 U.S.C. 112(b).
12. Claim 2 recites the limitation “a connection part base substrate” in lines 1-2. This recitation renders the claim indefinite, as it is not clear whether the recited “a connection part base substrate” is intended to comprise the “flexible substrate” of the “connection part” previously recited in independent claim 1 (from which claim 2 depends), or a separate/additional substrate of the connection part. As such, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
13. Claim 2 recites the limitation “a wiring” in line 3. This recitation renders the claim indefinite, as it is not clear whether the recited “a wiring” is intended to comprise the “wiring” of the “connection part” previously recited in independent claim 1 (from which claim 2 depends), or a separate/additional wiring of the connection part. As such, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
14. Claim 3 recites the limitation “the connection base substrate” in line 2. There is insufficient antecedent basis for this recitation in the claim.
15. Claim 3 recites the limitation “the one surface” in line 2. There is insufficient antecedent basis for this recitation in the claim.
16. Claim 20 recites the limitation “wherein the spacer layer is disposed on a side opposite to an end to be inserted into the human body between the plurality of electrode parts” in lines 1-3. This recitation renders the claim indefinite, as claim 19 (from which claim 20 depends) recites that “the electrode part comprises a plurality of electrode parts,” while independent claim 1 (from which claim 19 depends) requires that the electrode part is “configured to be inserted into a human body.” As such, it is not clear how the spacer layer can be disposed “between the plurality of electrode parts,” which are configured to be inserted into a human body, yet also be disposed on a side opposite to an end to be inserted into the human body. For this reason, the structure required by the claim (particularly, the location/positioning of the spacer layer) is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
17. Claim 21 is rejected as ultimately depending from a claim (claim 20) rejected under 35 U.S.C. 112(b).
18. Claim 21 recites the limitations “…the spacer layer comprises a first spacer portion… and a second spacer portion,” “the first and second spacer portions are disposed in the spacer layer,” and “the second spacer portion is disposed on an end side to be inserted into the human body” in lines 2-5. This recitation renders the claim indefinite, as it is not clear how the second spacer portion (which is part of the spacer layer) can be “disposed on an end side to be inserted into the human body” when claim 20 (from which claim 21 depends) requires that the spacer layer (which includes the second spacer portion) be “disposed on a side opposite to an end to be inserted into the human body.” For this reason, the structure required by the claim (particularly, the location/positioning of the spacer layer and its second spacer portion) is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
Claim Rejections - 35 USC § 103
19. 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.
20. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
21. Claims 1-4, & 13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2023/0045240 to Park (“Park”) in view of U.S. 2013/0126215 to Cho et al. ("Cho").
22. Regarding claim 1, and with reference to annotated FIG. 2 (provided below), Park teaches a neural probe [e.g., Abstract, ¶[0051]] comprising an electrode part [labelled in annotated FIG. 2 below, comprising electrode sites (120)] configured to be inserted into a human body [e.g., ¶[0042]], and a connection part [labelled in annotated FIG. 2 below, comprising contacts (130) (FIG. 1)] connected to the electrode part [via interconnector (140) - ¶’s [0038], [0046]; FIG. 1] and provided with a terminal [any of contacts (130) - ¶’s [0038], [0044]; FIG. 1] that is electrically connected to electrodes [electrode sites (120) - ¶’s [0038], [0040], [0042]];
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Annotated FIG. 2 of Park
wherein the electrode part and the connection part each comprise a flexible substrate [substrate (110) - ¶’s [0038], [0055]-[0058]; FIG. 1], a wiring [interconnector (140) - ¶’s [0039], [0046], [0047]; FIGS. 1-2] formed on the substrate [(110)] [FIGS. 1-2], and an insulation layer [overlayer (150) - ¶’s [0053], [0057], [0058]; FIGS. 1-2] covering the substrate [(110)] and the wiring [(140)] [clearly shown in FIG. 1];
wherein the electrode part comprises the electrodes [(120)] disposed on one surface [upper surface] of the substrate [(110)] and connected to the wiring [(140)] [e.g., ¶[0046]; FIGS. 1-2]; [and]
wherein the connection part comprises a terminal [any of contacts (130)] formed on one surface [upper surface] of the substrate [(110)] and connected to the wiring [(140)] [e.g., ¶[0046]; FIGS. 1-2].
DUMMY PATTERN
Park does not, however, teach:
wherein the connection part comprises a dummy pattern portion separated from the electrodes or terminal.
Cho, in a similar field of endeavor, teaches a printed circuit board and a method of manufacturing the same [e.g., ¶[0004]], and is concerned with various drawbacks associated with the miniaturization and thinning of circuit patterns formed on a PCB, including electromagnetic waves generated from circuit patterns or electronic components that exert a bad effect on, e.g., a human body [¶[0008]].
More particularly, Cho teaches a printed circuit board (100), which may be single-sided, multi-layer, or double-sided (see ¶[0056]), comprising a substrate (110), a circuit pattern (150), and a dummy pattern (170) formed on the surface of the substrate (110), where the circuit pattern (150) is not formed, by being spaced apart from the circuit pattern (150) by a predetermined interval so as not to be connected to the circuit pattern (150) [¶[0060]].
Cho teaches that the provision of a dummy pattern provides the benefits/advantages of improving heat radiation characteristics and obtaining an effect of shielding electromagnetic waves at the same time by wholly applying the dummy pattern (170) on the remaining region except for the region of the substrate (110) in which an electrical connection terminal or circuit pattern (150) is formed [e.g., ¶[0062]].
Cho additionally teaches that the dummy pattern (170) can act as a stiffener to help ensure structural stability of the substrate (110) [e.g., ¶[0064]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Park such that the substrate, which includes the connection part, comprises a dummy pattern portion separated from the electrodes or terminal since such a modification would provide the benefits/advantages of improving heat radiation characteristics, obtaining an effect of shielding electromagnetic waves that may exert a bad influence on the human body, and/or providing an added measure of structural stability to the substrate, as explicitly taught by Cho.
23. Regarding claim 2, the combination of Park and Cho teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
As best understood [see rejections under § 112(b) above], Park further teaches wherein the connection part [labelled in annotated FIG. 2 above, comprising contacts (130) (FIG. 1)] comprises:
a connection part base substrate [substrate (110) of the connection part - FIGS. 1,2];
the terminal [any of contacts (130) - ¶’s [0038], [0044]; FIG. 1] formed on one surface [upper surface] of the connection part base substrate [(110)] [FIGS. 1, 2]; [and]
a wiring [interconnector (140)] electrically connecting the terminal [(130)] and the electrode part on the one surface [upper surface] of the connection part base substrate [(110)] [e.g., ¶[0046]; FIGS. 1-2].
Park was modified above (in the rejection of claim 1) to include the dummy pattern portion of Cho on the substrate, which includes the connection part base substrate, while being spaced apart from the terminal and the wiring [Cho teaches that the dummy pattern portion is spaced apart from the of region of the substrate (110) in which an electrical connection terminal or circuit pattern (150) is formed (e.g., ¶[0062])].
24. Regarding claim 3, the combination of Park and Cho teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Park was modified above (in the rejection of claim 1) to include the dummy pattern portion of Cho on the substrate.
Park/Cho further teaches wherein the dummy pattern portion is formed on a surface of the connection base substrate different from the one surface of the connection base substrate on which the wiring and the terminal are formed [Cho further teaches that the dummy pattern can be placed on upper and lower surfaces of the substrate - see, e.g., ¶[0057]].
25. Regarding claim 4, the combination of Park and Cho teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Park was modified above (in the rejection of claim 1) to include the dummy pattern portion of Cho on the substrate.
Park/Cho further teaches wherein the dummy pattern portion is formed to have a pattern different from a pattern of the electrodes [broadly, a plate shape or mesh structure - see Cho, ¶[0061]].
26. Regarding claim 13, the combination of Park and Cho teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Park further teaches wherein the insulation layer [overlayer (150)] covers some of the electrodes [(120)] and comprises through holes [openings (151) - ¶[0053]; FIG. 1] so that the electrodes [(120)] have exposed surfaces [¶[0053]; FIG. 1].
27. Claims 5-7 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Park and Cho, and further in view of U.S. 2018/0369572 to Schouenborg et al. ("Schouenborg").
28. Regarding claim 5, the combination of Park and Cho teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
As noted above, Park teaches an insulation layer [overlayer (150) - ¶’s [0053], [0057], [0058]; FIGS. 1-2].
The combination of Park and Cho does not, however, teach:
wherein the insulation layer comprises a first insulation layer, and a second insulation layer having higher flexibility than the first insulating layer.
Schouenborg, in a similar field of endeavor, teaches a microelectrode for implantation into soft tissue, in particular nervous tissue [e.g., ¶[0001]].
Schouenborg further teaches that it was known in the art for a microelectrode to utilize an insulating layer comprising a first insulating material at a proximal section thereof [first insulation layer], and a second, different insulating material at a distal section thereof that is resilient [second insulation layer] [e.g., ¶’s [0022], [0073], claims 7, 10].
Given that Park is concerned with providing a substrate [(110)] and an insulating layer [overlayer (150)] that are mechanically flexible so as to conform to tissue (e.g., such as surfaces of the cerebral cortex) without cracking or splitting [Park, e.g., ¶’s [0056]-[0057]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Park and Cho to utilize a known, art-recognized insulation configuration for an implantable device, including one wherein the insulation layer comprises a first insulation layer, and a second insulation layer having higher flexibility [more resilient] than the first insulating layer, since such a particular known insulation configuration was clearly recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Schouenborg, and one of ordinary skill in the art would have been capable of applying this known insulation configuration to the known device of Park/Cho, and the results [utilizing a flexible/resilient insulation layer at a distal insertion section to effectuate better conformance to tissue] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
29. Regarding claim 6, the combination of Park, Cho, and Schouenborg teaches all of the limitations of claim 5 for the reasons set forth in detail (above) in the Office Action.
The combination of Park, Cho, and Schouenborg further teaches:
wherein part of the insulation layer covering the substrate is the second insulation layer [NOTE: the substrate in Park runs the entire length of the device (see FIGS. 1-2); as such, as modified, the second insulation layer (at the distal section of the device) would also cover the substrate, as broadly as currently claimed].
30. Regarding claim 7, the combination of Park, Cho, and Schouenborg teaches all of the limitations of claim 5 for the reasons set forth in detail (above) in the Office Action.
The combination of Park and Cho was modified above (in the rejection of claim 5) such that the insulating layer comprise a first insulating material [first insulation layer] at a proximal section thereof, and a second, different insulating material [second insulation layer] at a distal section thereof.
As such, the combination of Park, Cho, and Schouenborg further teaches:
wherein an insulation layer covering the connection part and an insulation layer covering a portion of the electrode part connected to the connection part are the first insulation layer [NOTE: the substrate in Park runs the entire length of the device (see FIGS. 1-2); as such, as modified, the first insulation layer (at the proximal section of the device) would therefore cover the connection part as well as a proximal portion of the electrode part connected to the connection part].
31. Regarding claim 14, the combination of Park and Cho teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Park and Cho does not, however, teach:
a protective film covering at least one surface of the electrode part.
Schouenborg, in a similar field of endeavor, teaches a microelectrode for implantation into soft tissue, in particular nervous tissue [e.g., ¶[0001]].
Schouenborg further teaches that it was known in the art to provide, as a protective film, an outer layer of a friction reducing material, which dissolves or disintegrates upon insertion of the microelectrode into nervous tissue [see, e.g., ¶’s [0078], [0095]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Park and Cho to include a protective film covering at least one surface of the electrode part, since all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
32. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Park, Cho, & Schouenborg, as applied to claim 7 above, and further in view of U.S. 2017/0232250 to Kim et al. ("Kim").
33. Regarding claim 8, the combination of Park, Cho, and Schouenborg teaches all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
The combination of Park and Cho was modified above (in the rejection of claim 5) such that the insulating layer comprise a first insulating material [first insulation layer] at a proximal section thereof, and a second, different insulating material [second insulation layer] at a distal section thereof. As further noted in the rejection of claim 7 (above), because the substrate in Park runs the entire length of the device (see FIGS. 1-2), the first insulation layer (at the proximal section of the device) would cover the connection part.
While Park teaches deep brain electrical stimulation [Abstract], and that the connection part includes the contacts (130) that receive signals recorded at the electrode sites (120), and allows the electrode sites (120) to be electrically connected to an external device [see ¶’s [0053], [0054]], the combination of Park, Cho, and Schouenborg does not teach:
wherein a drive circuit connected to the electrodes is mounted at a location corresponding to [being covered by] the first insulation layer [i.e., at/on the connection part].
Kim, in a similar field of endeavor, teaches an electrode array for a neural implant [Abstract], comprising an electrode portion (610), a sealed package portion (630), and a lead wire pattern portion (620) connecting the electrode portion (610) to the sealed package portion (630) [see ¶[0074]; FIG. 6].
Kim further teaches that it was known in the art to mount an electronic component (or module) on the sealed package portion [e.g., ¶’s [0074], [0080]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Park, Cho, and Schouenborg such that a drive circuit connected to the electrodes be mounted at a location corresponding to [being covered by] the first insulation layer [i.e., at/on the connection part], since such a particular known module/component placement configuration was clearly recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Kim, and one of ordinary skill in the art would have been capable of applying this known module/component placement configuration to the known device of Park/Cho/Schouenborg, and the results [placement of a drive circuit on the connection part such that it is mounted at a location corresponding to (being covered by) the first insulation layer] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
34. Claims 9 & 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Park and Cho, and further in view of U.S. 2014/0277317 to Tooker et al. ("Tooker").
35. Regarding claim 9, the combination of Park and Cho teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Claim 9 further requires the limitation “wherein the electrode part and the connection part comprise an additional insulation layer covering the substrate on a remaining surface of the substrate.”
As an initial matter, Park does not teach a second electrode on a remaining surface (e.g., a bottom surface) of the substrate.
However, the provision of electrodes on multiple surfaces of a substrate was well known in the art, before the effective filing date of the claimed invention.
As one non-limiting example, Tooker, in a similar field of endeavor, relates to microelectrode arrays and methods of fabricating microelectrode arrays [e.g., ¶[0004]] for forming a flexible neural interface for implantation in humans [e.g., ¶[0027]].
More particularly, Tooker teaches creating a neural interface with electrodes on the top surface [i.e., one surface] and the bottom surface [i.e., the remaining surface] of a multilayer body [or substrate] [e.g., ¶[0060]; see also, e.g., ¶[0072] and FIGS. 5A-5B, as well as ¶[0073] and FIGS. 6A-6B]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Park and Cho such that a second electrode be disposed on a remaining surface [bottom surface] of the substrate since such a modification would provide the benefit/advantage of enabling the conduction of deep brain stimulation and neural detection at multiple sites/locations [e.g., at a site/location facing the top surface of the probe, and at a site/location facing the bottom surface of the probe] without having to re-position the probe.
As modified such that the remaining surface (bottom surface) of the substrate include one or more additional electrodes, it would have likewise been obvious to further modify the combination of Park, Cho, & Tooker such that the electrode part and the connection part comprise an additional insulation layer covering the substrate on the bottom surface of the substrate to protect the circuitry mounted thereon similar to the manner in which the insulation layer in Park is applied to the top surface thereof to protect the circuitry mounted thereon.
36. Regarding claim 15, the combination of Park and Cho teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Park further teaches wherein the electrodes [(120)] comprise a first electrode [any of electrodes (120)] disposed on one surface [upper surface] of the substrate [(110)] [clearly shown in FIGS. 1-2].
The combination of Park and Cho does not, however, explicitly teach:
a second electrode disposed on a remaining surface thereof.
Tooker, in a similar field of endeavor, relates to microelectrode arrays and methods of fabricating microelectrode arrays [e.g., ¶[0004]] for forming a flexible neural interface for implantation in humans [e.g., ¶[0027]].
More particularly, Tooker teaches creating a neural interface with electrodes on the top surface [i.e., one surface] and the bottom surface [i.e., the remaining surface] of a multilayer body [or substrate] [e.g., ¶[0060]; see also, e.g., ¶[0072] and FIGS. 5A-5B, as well as ¶[0073] and FIGS. 6A-6B]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Park and Cho such that a second electrode be disposed on a remaining surface [bottom surface] of the substrate since such a modification would provide the benefit/advantage of enabling the conduction of deep brain stimulation and neural detection at multiple sites/locations [e.g., at a site/location facing the top surface of the probe, and at a site/location facing the bottom surface of the probe] without having to re-position the probe.
37. Regarding claim 16, the combination of Park, Cho, & Tooker teaches all of the limitations of claim 15 for the reasons set forth in detail (above) in the Office Action.
Park/Cho was modified above (in the rejection of claim 15) to include a second electrode disposed on a remaining surface [bottom surface] of the substrate.
Tooker further teaches wherein the first electrode disposed on the one surface of the substrate and the second electrode disposed on the remaining surface thereof are disposed at locations corresponding to each other [see Tooker - e.g., ¶[0073] (“The top electrodes 604 and the bottom electrodes 606 can be overlaid directly on top of each other (6A) or offset from each other (6B). Both layers of electrodes (top and bottom) can be arranged independently in a variety of ways (i.e. straight lines, grouped together), with different inter-electrode spacings, shapes (i.e. circular, oval, square, rectangular), and sizes. It is possible to create a variety of differently shaped and sized electrodes on a single neural interface”)].
38. Regarding claim 17, the combination of Park, Cho, & Tooker teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Park/Cho was modified above (in the rejection of claim 15) to include a second electrode disposed on a remaining surface [bottom surface] of the substrate.
Tooker further teaches a via or through hole formed through the substrate to connect the first and second electrodes [as broadly as claimed, the space that allows each electrode to connect to an interconnection trace metal (e.g., ¶[0062]) (the current claim language does not require that the first & second electrodes b connected to one another)].
39. Claims 10 & 11 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Park, Cho, & Tooker, as applied to claim 9 above, and further in view of Schouenborg.
40. Regarding claim 10, the combination of Park, Cho, & Tooker teaches all of the limitations of claim 9 for the reasons set forth in detail (above) in the Office Action.
The combination of Park, Cho, & Tooker does not, however, teach:
wherein the additional insulation layer comprises a first insulation layer, and a second insulation layer having higher flexibility than the first insulation layer.
Schouenborg, in a similar field of endeavor, teaches a microelectrode for implantation into soft tissue, in particular nervous tissue [e.g., ¶[0001]].
Schouenborg further teaches that it was known in the art for a microelectrode to utilize an insulating layer comprising a first insulating material at a proximal section thereof [first insulation layer], and a second, different insulating material at a distal section thereof that is resilient [second insulation layer] [e.g., ¶’s [0022], [0073], claims 7, 10].
Given that Park is concerned with providing a substrate [(110)] and an insulating layer [overlayer (150)] that are mechanically flexible so as to conform to tissue (e.g., such as surfaces of the cerebral cortex) without cracking or splitting [Park, e.g., ¶’s [0056]-[0057]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Park, Cho, & Tooker to utilize a known, art-recognized insulation configuration for an implantable device, including one wherein the additional insulation layer comprises a first insulation layer, and a second insulation layer having higher flexibility [more resilient] than the first insulating layer, since such a particular known insulation configuration was clearly recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Schouenborg, and one of ordinary skill in the art would have been capable of applying this known insulation configuration to the known device of Park/Cho/Tooker, and the results [utilizing a flexible/resilient insulation layer at a distal insertion section to effectuate better conformance to tissue] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
41. Regarding claim 11, the combination of Park, Cho, Tooker, & Schouenborg teaches all of the limitations of claim 10 for the reasons set forth in detail (above) in the Office Action.
The combination of Park, Cho, & Tooker was modified above (in the rejection of claim 10) such that the insulating layer comprise a first insulating material [first insulation layer] at a proximal section thereof, and a second, different insulating material [second insulation layer] at a distal section thereof.
As such, the combination of Park, Cho, Tooker, and Schouenborg further teaches:
wherein an additional insulating layer covering the connection part and an additional insulation layer covering a portion of the electrode part connected to the connection part are the first insulation layer [NOTE: the substrate in Park runs the entire length of the device (see FIGS. 1-2); as such, as modified, the first insulation layer (at the proximal section of the device) would therefore cover the connection part as well as a proximal portion of the electrode part connected to the connection part].
42. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Park, Cho, Tooker, & Schouenborg as applied to claim 11 above, and further in view of Kim.
43. Regarding claim 12, the combination of Park, Cho, Tooker, & Schouenborg teaches all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
While Park teaches deep brain electrical stimulation [Abstract], and that the connection part includes the contacts (130) that receive signals recorded at the electrode sites (120), and allows the electrode sites (120) to be electrically connected to an external device [see ¶’s [0053], [0054]], the combination of Park, Cho, Tooker, & Schouenborg does not teach:
wherein a drive circuit connected to the electrodes is mounted at a location corresponding to [being covered by] the first insulation layer [i.e., at/on the connection part].
Kim, in a similar field of endeavor, teaches an electrode array for a neural implant [Abstract], comprising an electrode portion (610), a sealed package portion (630), and a lead wire pattern portion (620) connecting the electrode portion (610) to the sealed package portion (630) [see ¶[0074]; FIG. 6].
Kim further teaches that it was known in the art to mount an electronic component (or module) on the sealed package portion [e.g., ¶’s [0074], [0080]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Park, Cho, Tooker, & Schouenborg such that a drive circuit connected to the electrodes be mounted at a location corresponding to [being covered by] the first insulation layer [i.e., at/on the connection part], since such a particular known module/component placement configuration was clearly recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Kim, and one of ordinary skill in the art would have been capable of applying this known module/component placement configuration to the known device of Park/Cho/Tooker/Schouenborg, and the results [placement of a drive circuit on the connection part such that it is mounted at a location corresponding to (being covered by) the first insulation layer] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
44. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Park and Cho, as applied to claim 1 above, and further in view of U.S. 2010/0100152 to Martens et al. ("Martens").
45. Regarding claim 18, the combination of Park and Cho teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
The combination of Park and Cho does not, however, explicitly teach:
wherein at least some of the electrodes are connected in parallel by the wiring.
Martens, in a similar field of endeavor, relates to an electrode system for deep brain stimulation comprising an elongated probe body with a plurality of stimulation electrodes [e.g., ¶[0001]].
Martens teaches that it was known to connect the electrodes in parallel to the output of just a single pulse-generator so that the shape and position of the volume of neuronal activation (VOA) can be controlled to a high degree of accuracy, which allows shifting of the VOA along the probe axis, as well as to elongate or compress the VOA along the direction of the probe axis [e.g., ¶[0050]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Park and Cho such that at least some of the electrodes are connected in parallel by the wiring for the benefits/advantages explicitly identified in ¶[0050] of Martens (which have been stated above). Still further, such a particular known electrode connection technique was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Marten, and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Park/Cho, and the results would have been predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
46. Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Park and Cho, as applied to claim 1 above, and further in view of U.S. 2014/0288458 to Yoon et al. ("Yoon").
47. Regarding claim 19, the combination of Park and Cho teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Park further teaches wherein the electrode part [comprising electrode sites (120)] comprises a plurality of electrode parts [e.g., ¶[0038]; FIGS. 1-2] connected to the connection part [the part comprising contacts (130)] [¶’s [0038], [0040], 0042]; FIGS. 1-2].
The combination of Park and Cho does not, however, teach:
[wherein] a spacer layer is disposed between the plurality of electrode parts.
Yoon, in a similar field of endeavor, relates generally to biocompatible devices for implantation or insertion into biological tissue and, more specifically, to neural probes [¶[0001]].
More particularly, Yoon teaches a neural probe, including a body, a tip, and a shank extending from the body to the tip. The neural probe includes one or more electrodes supported by the tip for stimulating neurons, recording neural electrical activity, or both [¶[0003]]. Yoon teaches that the one or more electrodes may be located anywhere along the shank and/or tip [¶[0025]].
Yoon additionally teaches that one or more portions of the neural probe may be coated with a biodegradable polymer that temporarily provides certain probe components with a mechanical stiffness that is sufficiently high for insertion into the desired biological tissue. The biodegradable material may begin to degrade after insertion and completely degrade thereafter [¶[0023]]. When applied, Yoon teaches that the coating fills the regions between branches of electrodes [e.g., ¶[0028]]. As such, it is the Examiner’s position that Yoon teaches a spacer layer (comprised of the biodegradable polymer coating) disposed between the plurality of electrode parts.
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Park and Cho to include a spacer layer (comprised of an applied biodegradable polymer coating) disposed between the plurality of electrode parts (disposed in the regions between the electrodes), since such a modification would provide the benefit/advantage of facilitating insertion of the probe by temporarily providing the probe with a mechanical stiffness that is sufficiently high for insertion into the desired biological tissue, as explicitly taught by Yoon.
48. Regarding claim 20, the combination of Park, Cho, & Yoon teaches all of the limitations of claim 19 for the reasons set forth in detail (above) in the Office Action.
The combination of Park & Cho was modified above (in the rejection of claim 19) to include the spacer layer (coating) of Yoon.
As best understood [see rejection under § 112(b) above], Yoon further teaches wherein the spacer layer is disposed on a side opposite to an end to be inserted into the human body between the plurality of electrode parts [Yoon teaches that the coating may be applied to both the tip (the end to be inserted) and the shank (which extends proximally from the tip in the opposite direction) - e.g., ¶[0024]].
49. Regarding claim 21, the combination of Park, Cho, & Yoon teaches all of the limitations of claim 20 for the reasons set forth in detail (above) in the Office Action.
The combination of Park & Cho was modified above (in the rejection of claim 19) to include the spacer layer (coating) of Yoon.
As best understood [see rejection under § 112(b) above], Yoon further teaches wherein at least the spacer layer comprises a first spacer portion made of a bio-insoluble adhesive and a second spacer portion made of a bio-soluble adhesive, and the first and second spacer portions are disposed in the spacer layer, and the second spacer portion is disposed on an end side to be inserted into the human body [broadly, the portions of coating disposed between electrodes may be considered “portions,” and the coating may be comprised of various different materials (¶’s [0028]-[0029]) that degrade at different rates (¶[0033])].
Conclusion
50. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Bradford C. Blaise whose telephone number is (571) 272-5617. The Examiner can normally be reached on Monday - Friday, 8:30 AM - 4:30 PM MST.
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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 telephone number 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADFORD C. BLAISE/Primary Examiner, Art Unit 3794
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