DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Claims 25-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/12/25.
Claim Objections
Claim 5 is objected to because of the following informalities: lines 1-2 should be amended to - wherein at least one electrode of the plurality of electrodes is in both the first set and the second set of electrodes-. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: lines 1-2 should be amended to - wherein none of the electrodes of the plurality of electrodes are in both the first set and the second set of electrodes-. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-6 and 17-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 5:
The limitation “wherein at least one electrode of the plurality of electrodes is in both the first set and the second set” in lines 1-2 is unclear. The limitation is unclear because it indicates the first and second set of electrodes share electrodes but this is unclear because they are claimed as separate structures (see lines 5-8 of claim 1 on which this claim depends). In short, it’s unclear if the first and second set of electrodes are separate structure or the same structure. For the sake of examination, the office has assumed these are separate structures.
Claim 6 is rejected due to its dependence on claim 5.
Regarding claim 17:
The claim recites the limitation "the received power" in the final line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 18-24 is rejected due to their dependence on claim 17.
Regarding claim 24:
The claim recites the limitation "the electroporation circuit" in the final line of the claim. There is insufficient antecedent basis for this limitation in the claim.
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) 1-2, 5, 7-8, 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2004050056 A1 to Debruyne et al. (Debruyne) in view of WO 9639932 A1 to Raymond et al. (Raymond).
Regarding claim 1:
Debruyne discloses:
An apparatus (figures 1 and 3) comprising:
a body (20/50) configured to be at least partially implanted on or within a recipient (as shown in figure 1); and
a plurality of electrodes (51 and 41) positioned along the body (20/50), the plurality of electrodes (51 and 41) comprising:
a first set of electrodes (41) configured to apply electrical stimulation signals to at least a portion of the recipient (page 23, lines 35-page 24, line 10); and
a second set of electrodes (51) configured to apply an electric field to cell membranes of the recipient (see the “electrical filed” described in page 24, lines 10-26), the electric field configured to increase the permeability of the cell membranes to a substance (“drug” is released due to the electrical field, page 24, lines 10-26),
Debruyne fails to disclose:
At least one electrode of the first set of electrodes having a first length and at least one electrode of the second set of electrodes having a second length, the second length greater than the first length.
Raymond teaches:
An apparatus (figure 2) for locating a nerve that includes electrodes (36). The reference further teaches the length of the electrodes can be varied in order to better locate nerves (page 13, lines 10-15). Therefore, this reference teaches the length of electrodes is a results effective variable which can be varied to better locate nerves in the body.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Debruyne to vary the first length of the first set of electrodes to less than or greater than the second length of the second set of electrodes as taught by Raymond for the purpose of better locating nerves (page 13, lines 10-15) and since the length of the electrodes are results effective variables.
Regarding claim 2:
Debruyne discloses:
The apparatus of claim 1, wherein the body (20/50) is configured to be at least partially implanted within a cochlea of the recipient (as shown in figure 2), the first set of electrodes (41) are configured to apply the electrical stimulation signals to at least a portion of the cochlea (page 23, lines 35-page 24, line 10), and the second set of electrodes (51) are configured to apply the electric field to cell membranes of the cochlea (page 24, lines 10-26).
Regarding claim 5 (as best understood by the examiner, see the 35 USC 112(b) rejection above for the claim interpretation):
Debruyne discloses:
The apparatus of claim 1, wherein at least one electrode of the plurality of electrodes (51 and 41) is in both the first set and the second set (see the 35 USC 112(b) claim rejection above for the claim interpretation indicating that the first and second set of electrodes include different electrodes (see 51 and 41)).
Regarding claim 7:
Debruyne discloses:
The apparatus of claim 1, wherein none of the electrodes of the plurality of electrodes (51 and 41) are in both the first set and the second set (see figure 3 where the first 41 and second 51 electrodes are different electrodes).
Regarding claim 8:
Debruyne discloses:
The apparatus of claim 7, wherein the electrodes of the second set of electrodes (51) are in electrical communication with one another and are electrically isolated (inherent, the electrodes 51 generate electrical field while the electrodes 41 are for generating electrical stimulation (page 24, lines 10-26)) from the first set of electrodes (41).
Regarding claim 14:
Debruyne discloses:
The apparatus of claim 1, wherein the second set of electrodes (51) comprises an electrically conductive material (electrodes that are electrically active, page 24, lines 10-26) deposited onto an outer surface (as shown in figure 3) of the body (20/50).
Regarding claim 16:
Debruyne discloses:
The apparatus of claim 1, wherein the substance comprises a medicament (“drug”, page 24, lines 10-26) and/or deoxyribonucleic acid (DNA).
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2004050056 A1 to Debruyne et al. (Debruyne) and WO 9639932 A1 to Raymond et al. (Raymond) as applied to claim 2 above, and further in view of US 20120078337 A1 to Darley et al. (Darley).
Regarding claim 3:
Debruyne fails to disclose:
The apparatus of claim 2, further comprising at least one monopolar electrode configured to be implanted outside the cochlea such that an electrical pathway is formed for electrical current to flow between the at least one monopolar electrode and the second set of electrodes.
Darley teaches:
An apparatus/cochlear implant that includes ball monopolar electrodes (¶0006-0007) implanted under a temporalis muscle (¶0007). These implants are used for extra-cochlear electrodes stimulation (¶0005).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Debruyne to further include at least one monopolar electrode implanted under the temporalis muscle as taught by Darley for extra-cochlear electrodes stimulation (¶0005).
Regarding claim 4:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 3 by Debruyne and Darley:
The apparatus of claim 3, wherein the at least one monopolar electrode comprises a ball electrode configured to be placed under a temporalis muscle of the recipient and/or a plate electrode on the body (see the ball electrode implanted under the temporalis muscle (¶0007) of Darley incorporated into Debruyne).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2004050056 A1 to Debruyne et al. (Debruyne) and WO 9639932 A1 to Raymond et al. (Raymond) as applied to claim 5 above, and further in view of US 20090079265 A1 to Seligman et al. (Seligman).
Regarding claim 6:
Debruyne fails to disclose:
The apparatus of claim 5, further comprising multiplexer circuitry configured to multiplex at least some of the electrodes of the first set together.
Seligman teaches:
An apparatus for a cochlea implant (see figure 1) that includes a power supply (200 of figure 2) and controller (216) for the implant. The power supply further includes multiplexer circuitry (500B in figure 5b, ¶0060 and ¶0075) for supplying power to the controller (514). Further, the controller/power supply is connected to electrodes of the cochlea implant (¶0025, 0028, 0029).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Debruyne to further replace the controller and power supply of Debruyne with the controller and power supply (including the multiplexer) as taught by Seligman. This is a simple substitution of one known element (controller and power supply of Debruyne) for another (controller and power supply of Seligman) to obtain predictable results (to control and power the electrodes of the cochlea implant).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2004050056 A1 to Debruyne et al. (Debruyne) and WO 9639932 A1 to Raymond et al. (Raymond) as applied to claim 1 above, and further in view of WO 2010100643 A2 to Moses et al. (Moses).
Regarding claim 9:
Debruyne fails to disclose:
The apparatus of claim 1, wherein the electrodes of the second set of electrodes are configured to generate the electric field in response to a time- dependent magnetic field B(t) at the second set of electrodes, the magnetic field B(t) generated by a source external to the recipient.
Moses teaches:
Using an electrode assembly (¶0020) that generates and electric field (¶0020). Further, the field is generated through use of at least two time dependent magnetic fields (¶0088) generated by an external source (see the coils described in ¶0009).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Debruyne to generate the electric fields in the second set of electrodes with an external source/coils as taught by Moses which would be generated through at least two time dependent magnetic fields. This is a simple substitution of one known element (source for the electric field in Debruyne) for another (coils as taught by Moses) to obtain predictable results (to generate electric fields to disperse the drugs of the apparatus in Debruyne).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2004050056 A1 to Debruyne et al. (Debruyne) and WO 9639932 A1 to Raymond et al. (Raymond) as applied to claim 14 above, and further in view of US 20110087315 A1 to Richardson-Burns et al. (Richardson-Burns).
Regarding claim 15:
Debruyne fails to disclose:
The apparatus of claim 14, wherein the electrically conductive material comprises an electrically conductive hydrogel or polymer configured to dissolve away over a predetermined time period after being implanted within the recipient's body.
Richardson-Burns teaches:
An apparatus (¶figure 1a and 1b) that includes an electrode (“electrode”) to stimulate the brain or cochlear stimulation. The reference further indicates the electrode can be made from conductive polymers that dissolve over time (¶0058).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Debruyne to make the electrode of electrically conductive polymer that will dissolve over time as taught by Richardson-Burns. This is a simple substitution of one known element (conductive material of the electrode in Debruyne) for another (the electrode of electrically conductive polymer that will dissolve over time as taught by Richardson-Burns) to obtain predictable results (111).
Allowable Subject Matter
Claims 10-13 and 17-24 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20100094380-A1
Dadd
See the electrode 148
US-20170368331-A1
Murphy
See the electrode 150
US-20180169399-A1
Housley
See the electrode 400
US-20040225336-A1
Milojevic
See the electrode 80
US-8617097-B2
Dadd
See the electrode 250
US-20170120044-A1
PAWSEY
See the electrode 148
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/WESLEY G HARRIS/Examiner, Art Unit 3783