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 .
Response to Amendment
The amendment filed April 29, 2026 has been entered. Claims 1, 4, 13, 21 and 23 have been amended. Claims 2-3, 9, 14-15 are canceled. Claim 24 is new. Currently, claims 1, 4-8, 10-13, 16-24 are pending for examination.
Response to Arguments
Applicant's arguments filed April 29, 2026 with respect to the prior art arguments directed to limitations recited in claims 1 and 21 have been fully considered but they are not persuasive. Applicant argues on pages 9-11 that Ball et al. (US 2011/0202120) in view of Sieber et al. (US 2012/0197265) do not disclose or teach projections that “are configured such that vibration of the flexible array body by the vibration device results in generation of asymmetric frictional forces between the projection tip ends and cochlear tissue that move the flexible array body in an apical direction”. Applicant argues Ball et al. only discloses the projections 403 help align the electrode array as it is inserted within the cochlear scala while minimizing the surface area of the electrode array that contacts the cochlear tissue structure, and Ball et al. only discloses the resistance of the projections to withdrawal from the cochleostomy opening to reduce post-surgical trauma and degradation of the implant system. However these recognitions of the advantages of Ball et al.’s projections do not teach away from the projections being configured such that vibration of the flexible array body by the vibration device results in generation of asymmetric frictional forces between the projection tip ends and cochlear tissue that move the flexible array body in an apical direction. In response to applicant's argument that Ball et al.’s projections serve the advantages above, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
As stated in the previous Office action, Sieber et al. teaches the vibration of the flexible array body by a 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]). 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.
Applicant has not provided persuasive arguments against why the structure of the angled projections of Ball et al. would be incapable of moving the flexible array body in an apical direction when there is generation of asymmetric frictional forces between the projection tip ends and cochlear tissue. The projections of Ball et al. are angled and in contact with the cochlear tissue in the same manner as applicant’s claimed projections, and Ball et al. in view of Sieber et al. disclose a vibration device in the same manner as applicant’s claimed cochlear implant. Additionally, applicant’s own specification does not place particular emphasis on the configuration of the projections as providing the ability to move the flexible array body in an apical direction. Instead, para. [0041] states, “In particular, while the projections 108 are in contact with cochlear tissue (e.g., a wall of the scala tympani 14) at the angle θ and there is friction between the projection ends 144 and the cochlear tissue, actuation of the vibration device results in high-frequency whole-body oscillations of the flexible body 124. Asymmetric interactive normal forces are thereby created, which results in the generation of asymmetric frictional forces between the projection ends 144 and cochlear tissue that move the electrode array 106 in the apical direction A.” As emphasized, it appears that applicant’s own specification acknowledges the projection ends and the cochlear tissue have a frictional relationship, and nothing in the structure of the projections move the flexible array body in the apical direction. Instead, it is the vibration device itself that enables movement of the flexible array body in an apical direction through the generation of asymmetric frictional forces between the projection tip ends and the cochlear tissue. As stated above, Sieber et al. teaches a vibration device that results in the generation of asymmetric frictional forces between the flexible array body and adjacent cochlear tissue and moves the flexible array body in an apical direction.
Applicant also argues (p. 11) that Sieber et al. does not suggest adding the vibration generator 124 to any portion of the electrode carrier 106 and instead discloses it is located within the housing 122 of a separate instrument 120 only used during the insertion process. Claim 1 does not require the vibration device must be located within the apical region of the flexible array body. Instead, claim 1 requires the vibration device can be located within the apical region of the flexible array body or is located within the handle, the handle associated with the basal region of the flexible array body. Applicant has failed to acknowledge the previous Office action’s position that, “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”.
The arguments directed to claim 21 (p. 12-13) are unpersuasive for the same reasons as claim 1 above.
Applicant notes in I. Preliminary Remarks that now-canceled dependent claim 14 was not rejected based on prior art and has stated independent claim 13 now calls for the combination previously recited in dependent claim 14. However applicant has not incorporated the limitations of claim 14 in its entirety into claim 13.
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, 16-19 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, line 6 has been amended to recite, “vibrating the flexible array body with a vibration device within the flexible array body”. This limitation is indefinite to because it is not clearly claiming the structural relationship of the vibration device and the flexible array body. This limitation could be interpreted as “vibrating the flexible array body within the flexible array body with a vibration device”. However given the previous language of now-canceled claim 14, it is understood the applicant intended for the vibration device to be located within the flexible array body. It is suggested to amend claim 13 to state, “vibrating the flexible array body with a vibration device located within the flexible array body”.
Claims 16-19 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 13.
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, 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]); and a cochlear lead including 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 the cochlear lead including a handle associated with the basal region of the flexible array body, and a vibration device that is located within the apical region of the flexible array body 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 of the flexible array body onto the cochlear lead, 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 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]); and a cochlear lead including an electrode array 110, 401, operably coupled to the stimulation processor ([0004]) and 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 the electrode array further includes 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 into the cochlear lead, 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) 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
Claims 4 and 24 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. If claim 4 is rewritten into independent form to include all of the limitations of the base claim, the limitation, “or is located within the handle” (claim 1, lines 14-15) should be deleted. If claim 24 is rewritten into independent form to include all the limitations of the base claim, claim 23 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.
Claim 24 specifically requires the vibration device is located within the flexible array body of a cochlear implant. Wallace et al. (US 2010/0268312) discloses an actuator mechanism within a cochlear electrode array but it is not a vibration device. Simaan et al. (US 2012/0109274) discloses a vibration device but it is not located within the flexible array body of a cochlear implant.
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 ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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