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.
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, 16, 33 and 35 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:
Debruyne discloses:
The apparatus of claim 1, wherein at least one electrode of the plurality of electrodes (51 and 41) is configured to both apply the electrical stimulation signals to at least the portion of the recipient and apply the electric field to the cell membranes of the recipient (inherent since two electrodes (51 and 41) of the electrodes apply an electric field as indicated in page 24, lines 10-26 would apply an electrical stimulation signal and apply an electric field to the cell membranes).
Regarding claim 7:
Debruyne discloses:
The apparatus of claim 1, wherein none of the electrodes of the plurality of electrodes (51 and 41) are configured to both apply the electrical stimulation signals to at least the portion of the recipient and apply the electric field to the cell membranes of the recipient (41 applies stimulation to auditory system 12 and 51 creates an electrical field (page 24, lines 15-20)).
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).
Regarding claim 33:
The apparatus of claim 1, wherein the plurality of electrodes are configured to be placed into at least two modes of operation comprising:
an electroporation mode of operation during which the plurality of electrodes apply the electric field to the cell membranes (51 creates an electrical field (page 24, lines 15-20)); and
a stimulation mode of operation during which the plurality of electrodes provide stimulation signals to the portion of the recipient (41 applies stimulation to auditory system 12 (page 24, lines 15-20)).
Regarding claim 35:
The apparatus of claim 33, wherein, in the stimulation mode of operation, at least some electrodes of the plurality of electrodes (41 and 51) are in electrical communication with a stimulation signal source (22 or 29).
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, 34 and 36-38 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: claims 17-24 is/are allowed primarily because the prior art of record cannot anticipate Applicant’s claimed invention by a single reference nor render Applicant’s claimed invention obvious by the combination of more than one reference.
Furthermore, the prior art of record does not teach “a second circuit having a second resonant frequency, the second circuit configured to wirelessly receive magnetic induction power from a third device, the second set of electrodes configured to apply the electric field in response to the magnetic induction power from the third device” as within the context of the claimed invention as disclosed and within the context of the other limitations present in claim 17.
Therefore, the prior art of record cannot anticipate Applicant’s claimed invention by a single reference nor render Applicant’s claimed invention obvious by the combination of more than one reference.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 4/30/26 have been fully considered but they are not persuasive.
Regarding the 35 USC 103 of claim 1:
The applicant has argued that the Debruyne reference does not teach the limitation “a second set of electrodes configured to apply an electric field to cell membranes of the recipient, the electric field configured to increase the permeability of the cell membranes to a substance” (see page 8 of the remarks). The applicant argues that the Debruyne discloses the electric field in the rings/electrodes 51 is used to release the drugs from the member 50 and is not for increasing the permeability of the cell membranes (see page 9 of the remarks). The office disagree with this argument for several reasons. First, by releasing the drug from the member 51 increase the permeability of the cell membranes since they absorb more substance than before the drug was released. Second, the function would be inherent since radiating the cell membranes with an electric filed would increase the permeability as well since they are exposed to an electric field. For this reason, the applicant’s arguments are not persuasive and the above rejections are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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