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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/30/2026 has been entered.
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.
Claim(s) 19, 20, 22-25 and 41, 42 are rejected under 35 U.S.C. 103 as being unpatentable over by Masmanidis (US2009/0177144A1) in view of Corbett (US5515848).
Masmanidis discloses the claimed invention as follows (limitations not disclosed by Masmanidis are crossed out, below):
Claim 19. A micro-molded electrode having a base (601B, Fig. 6) tapering to one or more shafts (601A, Fig. 6), comprising:
an electrode substrate (101, Fig. 4);
multiple individually addressable sensors (202A, 202B in Fig. 4; see the electrodes in Fig. 5(B) and 5(C)) on at least one side of the electrode substrate, each individually addressable sensor comprising a bonding pad (pads visible but not numbered on the base, in Figs. 3A, 6, and 7(B) for example) at the base of the electrode electrically connected to an active site (202A, 202B in Fig. 4) on a single shaft of the one or more shafts of the electrode via an electrically conductive trace (visible but not numbered in Figs. 3 and 5 for example), the electrode having an active site on at least two different sides of the single shaft of the electrode, the two different sides opposite or adjacent each other (see 202A and 202B in Fig. 4); and
a coating (204A, 204B in Fig. 3; see [0036]) covering a first side of the electrode including at least one trace (the coating is patterned to expose the active sites, the traces not being exposed); and wherein
Claim 20. The micro-molded electrode of claim 19,
Claim 22. The micro-molded electrode of claim 19,
Claim 23. The micro-molded electrode of claim 22,
Claim 24. The micro-molded electrode of claim 22,
Claim 25. The micro-molded electrode of claim 19, wherein the one or more shafts are tapered. See Fig. 6.
Claim 41. The micro-molded electrode of claim 19, wherein the electrode substrate comprises glass (see “glass” in [0032] and [0035]), SiO2, silicon carbide, or a combination thereof.
Claim 42. The micro-molded electrode of claim 19,
Masmanidis discloses the claimed invention, except for the limitations crossed out, above.
Corbett discloses a microelectrode having a base tapering to a shaft having a rounded cross-sectional shape along the entire length of the shaft, which is semi-conical near the tip (see Figs. 36 and 37). Active sites 298 are disposed on the electrode substrate 294, and a biologically compatible dielectric coating 308 covers the entire microelectrode, except for the active sites (see col. 12, ln. 42 to col. 13, ln. 9), thereby rounding the two upper edges of the microelectrode shaft. One suitable dielectric is parylene-C (see col. 6, lns. 18-37).
In view of the teachings Corbett, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to form the micro-molded electrodes of Masmanidis to have a curved bottom surface as shown in Figs. 36 and 37 of Corbett, as a matter of selecting from among conventional microelectrodes shapes, with predictable results. The cross-sectional shape is rounded as claimed.
Further, Masmanidis already shows insulation layer 204A and 204B, which appear to have the same function as the Parylene-C layer mentioned by Corbett, but Masmanidis only mentions a polymer layer 204, such as parylene, is deposited over the sensors 202 (see [0036]) and is patterned, but does not clarify whether the entire micro-molded electrode is covered. In view of the teachings of Corbett, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to form the parylene layer 204 of Masmanidis over the entire micro-molded electrode, with predictable results, since such an arrangement is conventional. As a result, sharp edges would be rounded, due to the presence of the polymer layer thereon, relative to exposed substrate edges, thereby providing the shafts with a rounded cross-sectional shape.
Claim(s) 26-35 and 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over by Masmanidis in view of Corbett, further in view of Fang (previously-cited US2011/0125001A1).
Masmanidis discloses the claimed invention as follows (limitations not disclosed by Masmanidis are crossed out, below):
Claim 26. An array of micro-molded electrodes, comprising:
a plurality of micro-molded electrodes, each micro-molded electrode having a base (601B, Fig. 6) tapering to one or more shafts (601A, Fig. 6), comprising:
an electrode substrate (101, Fig. 4);
multiple individually addressable sensors (202A, 202B in Fig. 4; see the electrodes in Fig. 5(B) and 5(C)) on at least one side of the electrode substrate, each individually addressable sensor comprising a bonding pad (pads visible but not numbered on the base, in Figs. 3A, 6, and 7(B) for example) at the base of the electrode electrically connected to an active site (202A, 202B in Fig. 4) on a single shaft of the one or more shafts of the electrode via an electrically conductive trace (visible but not numbered in Figs. 3 and 5 for example), the electrode having an active site on at least two different sides of the single shaft of the electrode, the two different sides opposite or adjacent each other (see 202A and 202B in Fig. 4); and
a coating covering a first side of the electrode including at least one trace; and
Claim 27. The array of micro-molded electrodes of claim 26,
Claim 28. The array of micro-molded electrodes of claim 27,
Claim 29. The array of micro-molded electrodes of claim 27,
Claim 30. The array of micro-molded electrodes of claim 26, wherein: the plurality of micro-molded electrodes comprises a two-dimensional array of individual micro-molded electrodes (see Figs. 6 and 3(A));
Claim 31. The array of micro-molded electrodes of claim 30, wherein: the plurality of micro-molded electrodes comprises a plurality of individual micro-molded electrodes (see Figs. 6 and 3(A));
Claim 32. The array of micro-molded electrodes of claim 26,
Claim 33. The array of micro-molded electrodes of claim 32,
Claim 34. The array of micro-molded electrodes of claim 32,
Claim 35. The array of micro-molded electrodes of claim 34,
Claim 37. The array of micro-molded electrodes of claim 26, wherein the plurality of micro-molded electrodes comprises one or more of: barbed electrodes, flexible electrodes having a flexible substrate, surface electrodes, penetrating electrodes, drug delivering electrodes, light delivering electrodes, and electrical-stimulus delivering electrodes. See [0031].
Claim 38. The array of micro-molded electrodes of claim 26, wherein a length of the micro-molded electrode is: two times greater than its width six times greater than its width; or ten times greater than its width. See [0044]. The length of the shaft can be between 1 and 10 mm, and the width can be between 10-100 µm. For example, when the shaft is 1 mm long and 100 µm wide, the length-to-width ratio is 10.
Claim 39. The array of micro-molded electrodes of claim 26 wherein the one or more shafts are tapered. See Fig. 6.
Claim 40. The array of micro-molded electrodes of claim 26, wherein the plurality of micro-molded electrodes have semi-conical shafts. See Fig. 5.
Masmanidis discloses the claimed invention, except for the limitations crossed out, above.
Regarding the slotted base, Fang shows it is known to form arrays of 3D arrays of microelectrodes by attaching multiple 2D arrays 10 of microelectrodes to a base 40 having a plurality of slots 42, such that a base 11 of one of the 2D arrays is received in the slots, as shown in Figs. 5B and 5C. The slotted base includes conductive connections 43 that are adapted to electrically interact with bonding pads 130 of the micro-molded electrode, effective to allow the slotted base to receive electrical signals from each micro-molded electrode 12 connected to the slotted base. The conductive connections are comprised of silver paste (see [0032]). The slotted base includes insulation barriers (i.e., the insulating material of base 40) between the conductive connections.
In view of the teachings of Fang, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide a slotted base as that of Fang, and to correspondingly shape the end of the base of the microelectrodes, to engage the slots as taught by Fang. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to do so as an alternative to the method of forming 3D arrays taught by Masmanidis. Masmanidis provides a flexible cable (e.g. 63, Fig. 6) for each 2D microelectrode array, and stacks multiple 2D arrays and cables to form a 3D array (see Figs. 6 and 12). Fang teaches an alternative manner of implementing a 3D array of microelectrodes from 2D arrays of microelectrodes. Replacing one conventional manner of implementing a 3D microelectrode array from 2D microelectrode arrays with another conventional manner would have been obvious to one of ordinary skill in the art would have had predictable results.
Regarding the rounded edges and rounded cross-sectional shape, Corbett discloses a microelectrode having a base tapering to a shaft having a rounded cross-sectional shape along the entire length of the shaft, which is semi-conical near the tip (see Figs. 36 and 37). Active sites 298 are disposed on the electrode substrate 294, and a biologically compatible dielectric coating 308 covers the entire microelectrode, except for the active sites (see col. 12, ln. 42 to col. 13, ln. 9), thereby rounding the two upper edges of the microelectrode shaft. One suitable dielectric is parylene-C (see col. 6, lns. 18-37).
In view of the teachings Corbett, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to form the micro-molded electrodes of Masmanidis to have a curved bottom surface as shown in Figs. 36 and 37 of Corbett, as a matter of selecting from among conventional microelectrodes shapes, with predictable results. The cross-sectional shape is rounded as claimed.
Further, Masmanidis already shows insulation layer 204A and 204B, which appear to have the same function as the Parylene-C layer mentioned by Corbett, but Masmanidis only mentions a polymer layer 204, such as parylene, is deposited over the sensors 202 (see [0036]) and is patterned, but does not clarify whether the entire micro-molded electrode is covered. In view of the teachings of Corbett, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to form the parylene layer 204 of Masmanidis over the entire micro-molded electrode, with predictable results, since such an arrangement is conventional. As a result, sharp edges would be rounded, due to the presence of the polymer layer thereon, relative to exposed substrate edges, thereby providing the shafts with a rounded cross-sectional shape.
Regarding claim 35, Fang does not disclose the material of the barriers being as claimed. However, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to encapsulate the base 40 and all electrical traces, pads and connections with a biocompatible material such as Parylene-C, in order to prevent deterioration of components due to contact with body tissue, and to prevent adverse effects on the body due to contact with any materials that may not be biocompatible. As mentioned above, Corbett teaches covering the entire microelectrode with the dielectric material, to protect it. Extending this protection to the slotted base would have been obvious, for the same reason.
Claim(s) 36 is rejected under 35 U.S.C. 103 as being unpatentable over by Masmanidis in view of Corbett, further in view of Fang and further in view of Nishida (US2009/0292336A1).
Masmanidis as modified above renders obvious the claimed invention, except for the limitations of claim 36.
Nishida discloses a neural interface system including a base 22 to which microelectrode arrays 86 are attached (see Fig. 5). In order to implement a wireless data transmission mechanism, the base 22 includes a signal processing chip 52 and a wireless transceiver 54 (see [0029] and Fig. 5). The device also includes a rechargeable battery 24 and an induction coil 26 for recharging the battery, i.e. these constitute a power module.
Although the base and microelectrode arrays are structurally different from those of modified Masmanidis, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to add to the base of modified Masmanidis a wireless transceiver and a battery and coil, in order to allow for wireless use of the implanted 3D microelectrode array, with predictable results. Regarding the processing module, Fang already teaches this limitation (see Fig. 5C and [0032]).
Response to Arguments
Applicant’s arguments with respect to the claims 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.
Conclusion
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/LIVIUS R. CAZAN/Primary Examiner, Art Unit 3729
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