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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 26, 2025 has been entered.
Response to Amendment
The amendment filed November 8, 2025 has been entered. Claims 1, 4, 8, 13, 16, 21 and 23 have been amended. Claims 2-3, 9 are canceled. Currently, claims 1, 4-8, 10-23 are pending for examination.
Response to Arguments
Applicant’s arguments, see page 7, filed November 8, 2025, with respect to the 35 U.S.C. 112(b) rejection have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections of claims 4 and 23 have been withdrawn.
Applicant’s arguments, see pages 7-17, filed November 8, 2025, with respect to the rejection(s) of claim(s) 1, 4-8 and 10-23 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sieber et al. (US 2012/0197265).
Claim Objections
Claim 1 is objected to because of the following informalities: line 14 recites, “within apical region” and should state, “within the apical region” to properly refer back to what is recited in line 8. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: lines 2-3 recite, “within apical region” and should state, “within the apical region” to properly refer back to what is recited in claim 1, line 8. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: line 13 recites, “flexible array body, that each include a base end and a tip end” and should state, “flexible array body, and that each include a base end and a tip end”. This amendment would be consistent with the claim language of claim 1.
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 13-19 and 23 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.
Claim 13 recites the limitation, "the projection ends" in line 7. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this limitation is referring to the “base end” or the “tip end” of each of the flexible projections that are introduced in line 4, or if applicant intends for both base ends and tip ends to be referenced (which raises additional indefiniteness issues). For purposes of examination, line 7 will be interpreted as reciting “projection tip ends” to maintain consistency with amended in claims 1 and 21 (“the generation of asymmetric frictional forces between the projection tip ends and cochlear tissue”).
Claims 14-19 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 13.
Claim 23 recites the limitation, “the flexible array body within apical region”. There is insufficient antecedent basis for the limitation “apical region” in the claim. Neither claim 23 nor claim 21 (for which claim 23 directly depends) defines an apical region of any component of the cochlear implant.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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, 5-8, 10-11, 13, 15-17, 19, 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ball et al. (US 2011/0202120) in view of Sieber et al. (US 2012/0197265).
Regarding claim 1, Ball et al. discloses a cochlear implant, comprising: a housing 108; an antenna within the housing (“external signal processing stage 111 into a digital data format… for transmission into a receiver processor in an implant housing 108” [0004]; receipt of the transmission of digital data from 111 by 108 inherently requires an antenna as is well known in the art of cochlear systems); a stimulation processor within the housing ([0004]); an electrode array 110, 401, operably coupled to the stimulation processor ([0004]), including a flexible array body including a basal region and an apical region (fig. 1, 4b), a plurality of electrically conductive contacts 405 on the flexible array body, and a plurality of flexible projections 403 that extend outwardly from the flexible array body and that each include a base end and a tip end (fig. 4b; “the array projections 403 may be small diameter angled pointed barb projections having soft silicone elastomer tips that bend back as the electrode array 401 is inserted into target tissue, as shown for example, in FIG. 4B” [0020]).
Ball et al. does not expressly disclose a handle associated with the basal region, a vibration device that is located within the apical region or is located within the handle, wherein the flexible projections are configured such that vibration of the flexible array body by the vibration device results in the generation of asymmetric frictional forces between the projection tip ends and the cochlear tissue that move the flexible array body in an apical direction. Sieber et al. teaches a handle 120 for associating with a basal region of a flexible array body of an electrode carrier of a cochlear implant 106 (fig. 7), a vibration device 124 that is located within the handle (fig. 2), the vibration of the flexible array body by the vibration device results in the generation of asymmetric frictional forces between the flexible array body and adjacent cochlear tissue (“The frequency and amplitude of the vibrations produced by the vibration generator 124 are preferably chosen such that the oscillations produced in the electrode carrier help to overcome the friction effects and obstacles encountered when inserting the electrode carrier into the cochlea” [0027]) that move the flexible array body in an apical direction (“the instrument 120 may be configured so that the vibrations generated impart an axial motion to the housing 122 (as shown by the double-sided arrow), which may cause the electrode carrier 106 to move forward (as shown by the arrow) with a constant, incremental movement” [0034]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ball et al. to incorporate a handle associated with the basal region, with the vibration device located within the handle, wherein vibration of the flexible array body by the vibration device results in generation of asymmetric frictional forces between the flexible array body and the cochlear tissue that move the flexible array body in an apical direction as taught by Sieber et al. in order to promote “a constant, slow and atraumatic insertion process” ([0034]). Furthermore, the incorporation of the teachings of Sieber et al. into Ball et al. would result in the claimed limitation of, “the generation of asymmetric frictional forces between the projection tip ends and cochlear tissue that move the flexible array body in an apical direction” as one of ordinary skill in the art before the effective filing date of the claimed invention would find it obvious that given the structural relationship of the flexible array body and the flexible projections of Ball et al., the vibrations imparted on the flexible array body would translate through to the projection tip ends, resulting in the same generation of asymmetrical frictional forces between the projection tip ends and the cochlear tissue. One of ordinary skill in the art would also find it obvious that the disclosed structure of the flexible projections having angled pointed barb projections having soft silicone elastomer tips that bend back as the electrode array is inserted into target tissue would also allow for the vibration of the flexible array body by the vibration device resulting in moving in an apical direction and implanting further into the cochlea.
Regarding claim 5, Ball et al. discloses the flexible array body defines a longitudinal axis and an axial direction (fig. 4a-b), and Ball et al. in view of Sieber et al. disclose the vibration device is selected from the group consisting of a rotating out-of-balance mass (“gear having an unbalanced mass” [0010]), a mass that vibrates in the axial direction, and a mass that vibrates in a direction perpendicular to the axial direction.
Regarding claim 6, Ball et al. discloses the flexible array defines a longitudinal axis (fig. 4a-b); and the plurality of flexible projections includes first and second pluralities of flexible projections that are respectively located on opposite sides of the longitudinal axis (fig. 4b-c) and a plurality of flexible projections between the first and second pluralities of flexible projections (fig. 4a, 4d).
Regarding claim 7, Ball et al. discloses at least some of the flexible projections define an acute angle with the flexible array body (fig. 4c).
Regarding claim 8, Ball et al. discloses the flexible array body includes an apical end; the flexible projections each include a base end and a tip end; and at least some of the flexible projections are oriented such that the base end of the flexible projections is closer to the apical end of the flexible array body than the tip end of the flexible projections (fig. 4a-d).
Regarding claim 10, Ball et al. discloses the flexible projections are formed from the same material as the flexible array body (fig. 2).
Regarding claim 11, Ball et al. discloses the flexible projections are formed from different material than the flexible array body (“The array projections may be biologically resorbable over time into surrounding tissue. The array projections may include a lubricant coating, an anti-inflammatory coating, and/or a therapeutic pharmaceutical coating.” [0010]).
Regarding claims 13 and 15, Ball et al. discloses a method comprising: moving a cochlear implant electrode array 110, 401, including a flexible array body, a plurality of electrically conductive contacts 405 on the flexible array body, and a plurality of flexible projections 403, each having a base end and a tip end, that extend outwardly from the flexible array body and the tip ends are in contact with the cochlea (fig. 4b-c), when the electrode array is moved in an apical direction (“as the electrode array 401 is inserted into target tissue” [0020]).
Ball et al. does not expressly disclose the cochlear implant electrode array is moved in the apical direction by vibrating the flexible array body with a vibration device in such a manner that asymmetric frictional forces are created between the projection ends and the cochlea that move the electrode array in the apical direction. Sieber et al. teaches a handle 120 for associating with a basal region of a flexible array body of an electrode carrier of a cochlear implant 106 (fig. 7), a vibration device 124 that is located within the handle (fig. 2), the vibration of the flexible array body by the vibration device results in the generation of asymmetric frictional forces between the flexible array body and adjacent cochlear tissue (“The frequency and amplitude of the vibrations produced by the vibration generator 124 are preferably chosen such that the oscillations produced in the electrode carrier help to overcome the friction effects and obstacles encountered when inserting the electrode carrier into the cochlea” [0027]) that move the flexible array body in an apical direction (“the instrument 120 may be configured so that the vibrations generated impart an axial motion to the housing 122 (as shown by the double-sided arrow), which may cause the electrode carrier 106 to move forward (as shown by the arrow) with a constant, incremental movement” [0034]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ball et al. to incorporate a handle associated with the basal region, with the vibration device located within the handle, wherein vibration of the flexible array body by the vibration device results in generation of asymmetric frictional forces between the flexible array body and the cochlea that move the flexible array body in an apical direction as taught by Sieber et al. in order to promote “a constant, slow and atraumatic insertion process” ([0034]). Furthermore, the incorporation of the teachings of Sieber et al. into Ball et al. would result in the claimed limitation of, “the generation of asymmetric frictional forces between the projection ends and cochlea that move the flexible array body in an apical direction” as one of ordinary skill in the art before the effective filing date of the claimed invention would find it obvious that given the structural relationship of the flexible array body and the flexible projections of Ball et al., the vibrations imparted on the flexible array body would translate through to the projection ends, resulting in the same generation of asymmetrical frictional forces between the projection ends and the cochlea. One of ordinary skill in the art would also find it obvious that the disclosed structure of the flexible projections having angled pointed barb projections having soft silicone elastomer tips that bend back as the electrode array is inserted into target tissue would also allow for the vibration of the flexible array body by the vibration device resulting in moving in an apical direction and implanting further into the cochlea.
Regarding claim 16, Ball et al. in view of Sieber et al. disclose vibrating the flexible array body with the vibration device comprises supplying power 126 to the vibration device (“The power supply 126 supplies energy to the vibration generator 124” [0025]).
Regarding claim 17, Ball et al. in view of Sieber et al. disclose varying the amplitude and/or frequency of the vibrations ([0026-0028]).
Regarding claim 19, Ball et al. in view of Sieber et al. discloses the cochlear implant electrode array is connected to a cochlear implant stimulation assembly ([0004]); and supplying power comprises supplying power with a wired connection between the cochlear implant stimulation assembly and a power supply 126 (“a power supply 126 positioned within the housing 122 and coupled to the vibration generator 124” [0025]; wires, traces, etc. known in the art for connecting power supply to generators).
Regarding claims 21 and 23, Ball et al. discloses a cochlear implant, comprising: a housing 108; an antenna within the housing (“external signal processing stage 111 into a digital data format… for transmission into a receiver processor in an implant housing 108” [0004]; receipt of the transmission of digital data from 111 by 108 inherently requires an antenna as is well known in the art of cochlear systems); a stimulation processor within the housing ([0004]); an electrode array 110, 401, operably coupled to the stimulation processor ([0004]), including a flexible array body including a basal region (fig. 1, 4a-b), a plurality of electrically conductive contacts 405 on the flexible array body, and a plurality of flexible projections 403 that extend outwardly from the flexible array body (fig. 4b), and that each include a base end and a tip end (fig. 4b; “the array projections 403 may be small diameter angled pointed barb projections having soft silicone elastomer tips that bend back as the electrode array 401 is inserted into target tissue, as shown for example, in FIG. 4B” [0020]).
Ball et al. does not expressly disclose a handle associated with the basal region, a vibration device that is located within the handle, wherein the flexible projections are configured such that vibration of the flexible array body by the vibration device results in the generation of asymmetric frictional forces between the projection tip ends and cochlear tissue that move the flexible array body in an apical direction. Sieber et al. teaches a handle 120 for associating with a basal region of a flexible array body of an electrode carrier of a cochlear implant 106 (fig. 7), a vibration device 124 that is located within the handle (fig. 2), the vibration of the flexible array body by the vibration device results in the generation of asymmetric frictional forces between the flexible array body and adjacent cochlear tissue (“The frequency and amplitude of the vibrations produced by the vibration generator 124 are preferably chosen such that the oscillations produced in the electrode carrier help to overcome the friction effects and obstacles encountered when inserting the electrode carrier into the cochlea” [0027]) that move the flexible array body in an apical direction (“the instrument 120 may be configured so that the vibrations generated impart an axial motion to the housing 122 (as shown by the double-sided arrow), which may cause the electrode carrier 106 to move forward (as shown by the arrow) with a constant, incremental movement” [0034]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ball et al. to incorporate a handle associated with the basal region, with the vibration device located within the handle, wherein vibration of the flexible array body by the vibration device results in generation of asymmetric frictional forces between the flexible array body and the cochlear tissue that move the flexible array body in an apical direction as taught by Sieber et al. in order to promote “a constant, slow and atraumatic insertion process” ([0034]). Furthermore, the incorporation of the teachings of Sieber et al. into Ball et al. would result in the claimed limitation of, “the generation of asymmetric frictional forces between the projection tip ends and cochlear tissue that move the flexible array body in an apical direction” as one of ordinary skill in the art before the effective filing date of the claimed invention would find it obvious that given the structural relationship of the flexible array body and the flexible projections of Ball et al., the vibrations imparted on the flexible array body would translate through to the projection tip ends, resulting in the same generation of asymmetrical frictional forces between the projection tip ends and the cochlear tissue. One of ordinary skill in the art would also find it obvious that the disclosed structure of the flexible projections having angled pointed barb projections having soft silicone elastomer tips that bend back as the electrode array is inserted into target tissue would also allow for the vibration of the flexible array body by the vibration device resulting in moving in an apical direction and implanting further into the cochlea.
Regarding claim 22, Ball et al. discloses at least some of the flexible projections define an acute angle with the flexible array body (fig. 4c).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ball et al. (US 2011/0202120) in view of Sieber et al. (US 2012/0197265) and further in view of Parker et al. (US 5,653,742).
Regarding claim 12, Ball et al. does not expressly disclose the contacts are embedded within the flexible array body; and the flexible array body includes a plurality of windows that respectively expose portions of the contacts. Parker et al. teaches a more detailed cross-section of a known cochlear implant flexible array body, where contacts 16 are embedded within a flexible array body 12; and the flexible array body includes a plurality of windows that respectively expose portions of the contacts (fig. 4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ball et al. and try using the contacts-flexible array body structural relationship as taught by Parker et al., where the contacts are embedded within the flexible array body and a plurality of windows within the flexible array body expose portions of the contacts as it is a known structure for providing stimulation to the cochlea, such a modification being reasonably predictable and would not have altered the overall operation of the device.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ball et al. (US 2011/0202120) in view of Sieber et al. (US 2012/0197265) and further in view of Koka (US 2016/0051819).
Regarding claim 18, Ball et al. discloses the cochlear implant electrode array is connected to a cochlear implant stimulation assembly ([0004]) but does not expressly disclose supplying power comprises supplying power with a wireless transcutaneous connection between the cochlear implant stimulation assembly and a power supply. Koka teaches it is known in the art for a cochlear implant electrode array 206 to be connected to a cochlear implant stimulation assembly 106 (fig. 2); and supplying power with a wireless connection 110 between the cochlear implant stimulation assembly and a power supply is known in the art ([0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ball et al. to try using an external power supply to supply power via a wireless connection to a cochlear implant stimulation assembly connected to the cochlear implant electrode array as taught by Koka as it is a known configuration in cochlear implants, such a modification being reasonably predictable and would not alter the overall operation of the device.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ball et al. (US 2011/0202120) in view of Sieber et al. (US 2012/0197265) and further in view of Wallace et al. (US 2010/0268312).
Regarding claim 20, Ball et al. in view of Sieber et al. disclose a wired connection 415 connected to the electrode array and the handle to a controller 425 (fig. 4a; [0035]) but does not expressly disclose a plurality of wires that are respectively connected to the plurality of electrically conductive contacts. Wallace et al. teaches it is known in the art to provide a plurality of wires respectively connected to a plurality of electrically conductive contacts that extend through the array body ([0004], [0034]). It would have been obvious to one of ordinary skill in the art to modify the wired connection 415 of Ball et al. to comprise a plurality of wires, respectively connected to the plurality of electrically conductive contacts, as taught by Wallace et al. in order to allow for independent signals to be delivered between the controller and the contacts.
Allowable Subject Matter
Claim 4 is 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. If claim 4 is rewritten in independent form to include all of the limitations of the base claim, the emphasized limitation, “a vibration device that is located within apical region or is located within the handle” (claim 1, lines 14-15) should be deleted.
The following is a statement of reasons for the indication of allowable subject matter: Claim 4 specifically requires that the vibration device of claim 1 “is located within the flexible array body within [the] apical region and is located between adjacent electrically conductive contacts”. The closest prior art is Sieber et al. (US 2012/0197265) and Huttenbrink et al. (US 2012/0184804). Both references teach a vibration device for implanting a cochlear implant but neither describe the vibration device is located within the flexible array body within the apical region and is located between adjacent electrically conductive contacts of the cochlear implant. At best, Huttenbrink et al. discloses a vibration device adjacent electrically conductive contacts on the flexible array body of the cochlear implant.
Conclusion
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/ERICA S LEE/Primary Examiner, Art Unit 3796