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 examiner acknowledges the reply filed on 05/11/2026 in which claims 1-4, 7-18, 20, 21, 23-30, and 33, were amended. Currently, claims 1-33 are pending for examination in this application.
Terminal Disclaimer
The terminal disclaimer filed on 05/11/2026, disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of USPN 10,842,531 and USPN 11,116,963, has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant's arguments, filed 05/11/2026, have been fully considered but they are not persuasive. Applicant’s representative asserts that the prior art of record does not disclose the invention as claimed.
The examiner has fully considered the applicant’s arguments but they are not persuasive. It is the examiner’s position that given a careful reading, the claims do not distinguish over the prior art of record.
With regards to the prior art to Gibson, applicant’s representative asserts the structure taught by Gibson is not “capable of receiving a cochlear electrode array.” The examiner respectfully disagrees. Specifically, applicant’s representative’s argument is based on the prior art not specifically disclosing the functionally recited structure of a “cochlear electrode array.” A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As clearly highlighted in the rejected claims, the “cochlear electrode array” is never positively recited; thus, the “insertion guide” taught by Gibson must only be capable of accommodating said functionally recited cochlear electrode array. (The examiner notes claims 12 and 13 have been indicated as allowable due to the positive recitation of the cochlear electrode array located in the cochlear electrode array tool.) The rejected claims do not provide for any structural limitations of the “insertion guide,” other than that a lumen is provided. It is noted that said lumen is not defined by any specific size, orientation, or functionality, other than “configured to receive a cochlear electrode array.” Furthermore, the claims do not provide for any further functionally described limitations relative to the functionally recited “cochlear electrode array” (i.e. diameter, length, etc.). Additionally, it is noted that applicant’s representative’s arguments (Remarks; page 9) fail to present any specific arguments as to how the claimed invention has a structural difference from the prior art, such that the prior art would be unable to meet the functionally recited limitations. Given this, relative to the rejected claims, the examiner finds applicant’s representative’s arguments unconvincing.
In light of the remarks and standing rejection above, the examiner asserts the prior art of record teaches all elements as claimed and these elements satisfy all structural, functional, operational, and spatial limitations currently in the claims. Therefore, the standing rejections are proper and maintained.
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 3-6 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 3] The claim recites the limitation of “wherein the at least one electrical component is configured to activate to output stimulation in response to receiving electrical current.” The examiner is unable to determine the metes and bounds of the claim, as it is unclear what functionality is intended to be claimed. For purposes of examination, it is interpreted that the claim intends to recite “configured to activate and to output stimulation in response to receiving electrical current.”
[Claim 3] The claim recites the limitation of “wherein the at least one electrical component is configured to activate to output stimulation in response to receiving electrical current comprises.” The examiner is unable to determine the metes and bounds of the claim, since it is unclear if the word “comprises” was intended to be deleted with the most recent amendment, or if the claim was not properly completely. For purposes of examination, it is interpreted that the word “comprises” was intended to be deleted with the most recent amendment.
[Claim 23] The claim recites the limitations of “an electrode array.” The examiner is unable to determine the metes and bounds of the claims, since it is unclear if this limitation is the same or different from the previously recited “cochlear electrode array” of claim 17. For purposes of examination, the limitation is interpreted as “the cochlear electrode array.”
[Claims 4-6] The claims are rejected based upon their dependency from dependent claim 3.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gibson (PGPub 2009/0076581).
[Claim 1] Gibson teaches a cochlear electrode array insertion tool (figures 1 and 2a, items 142/200; paragraph [0029]), comprising:
an insertion guide (“carrier member”) (figures 2a and 5a, items 202/220) configured to receive a cochlear electrode array (the examiner notes the “cochlear electrode array” is only functionally recited and is therefore not a positively recited claim element) for insertion into a recipient (via lumen 224); and
at least one electrical component (figure 2a, items 250/252) disposed in or on (as best seen in figure 2b) the insertion guide (figures 2a and 5a, items 202/220), wherein at least a portion of the at least one electrical component (figure 2a, items 250/252) is fixed relative to (figure 2b) the insertion guide (figures 2a and 5a, items 202/220).
[Claims 2 and 3] Gibson teaches the limitations of claim 1, upon which claims 2 and 3 depend. Gibson further discloses the at least one electrical component (figure 2a, items 250/252) is configured to activate and to output stimulation (see 112b interpretation above) in response to receiving electrical current (paragraphs [0031] and [0032]).
[Claims 4-7] Gibson teaches the limitations of claim 3, upon which claims 4-7 depend. Gibson also teaches the at least one electrical component (figure 2a, item 250/252) comprises a plurality of electrodes (figure 2a, item 250; paragraph [0031]) which are formed into two or more functional groups of electrodes (the examiner notes the claim limitation of a “functional group,” lacking any explicit definition within applicants’ specification or limitations in the claims, is arbitrary; as such, the electrodes taught by the prior art could easily be viewed as multiple “functional groups”), forming a portion of a circuit (paragraph [0006]).
[Claims 8, 14, and 16] Gibson teaches the limitations of claim 1, upon which claims 8, 14, and 16, depend. Gibson further discloses the cochlear electrode array insertion tool (figures 1 and 2a, items 142/200) is configured to hold the electrical component (figure 2a, item 250/252) stationary (the examiner notes electrodes 250 and leads 252 are stationary and fixed to item 202/220) relative to the insertion guide (figures 2a and 5a, items 202/220), while a cochlear electrode array (the examiner notes the additional “electrode array” is only functionally recited as being used with the claimed tool) is being inserted through an empty elongate hollow portion (figure 2b, item 224) of the insertion guide (figures 2a and 5a, items 202/220) into a cochlea (figure 5a, item 115) using the tool (figures 1 and 2a, items 142/200).
[Claims 9-11] Gibson teaches the limitations of claim 1, upon which claims 9-11 depend. In addition, Gibson discloses the cochlear electrode array insertion tool (figures 1 and 2a, items 142/200) comprises an intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) and an extra-cochlear portion (figure 5a; portion proximal to cochleostomy 152), wherein the extra-cochlear portion (figure 5a; portion proximal to cochleostomy 152) facilitates manipulation of the cochlear electrode array insertion tool (figures 1 and 2a, items 142/200) during surgery (paragraph [0042]);
wherein the intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) is configured for insertion through a round window (“cochleostomy”; figure 5a, item 152) of a cochlea (figure 5a, item 115) (figure 5a; paragraph [0042]); and
wherein the insertion guide (figures 2a and 5a, items 202/220) includes a tube (figure 5a, item 224) that extends from (“in one embodiment, lumen 224 extends along electrode assembly 200 from outside cochlea 115 to inside the cochlea when the device is implanted in the cochlea. As such, electrode carrier member 202 may be configured so that opening 404 for lumen 224 is located outside cochlea 115 when the carrier member is implanted in cochlea 115.”) the extra-cochlear portion (figure 5a; portion proximal to cochleostomy 152) to the intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) (paragraphs [0042], [0043]), and wherein the tube (figure 5a, item 224) is configured to permit a cochlear electrode array (the examiner notes the additional “electrode array” is only functionally recited as being used with the claimed tool) to be advanced through the insertion guide (figures 2a and 5a, items 202/220) into a cochlea (figure 5a, item 115).
[Claim 15] Gibson teaches the limitations of claim 1, upon which claim 15 depends. Gibson also teaches the electrical component (figure 2a, items 250/252) is separate from a stimulator (figure 1, item 134) of an implantable portion (figure 1, item 124) of a cochlear implant (figure 1, item 120) that is in wired communication (figure 1; via item 140) with an electrode array (figure 1, item 144) of the cochlear implant (figure 1, item 120) insertable into a cochlea (figure 5a, item 115) using the cochlear electrode array insertion tool (figures 1 and 2a, items 142/200) (the examiner notes the “stimulator,” “cochlear implant,” and “electrode array” are only functionally recited for use with the claimed tool).
[Claims 17 and 22] Gibson teaches an electrode array insertion tool (figures 1 and 2a, items 142/200; paragraph [0029]), comprising:
an electrode array insertion guide (“carrier member”) (figures 2a and 5a, items 202/220); and
at least one electrode (figure 2a, item 250), wherein the electrode array insertion tool (figures 1 and 2a, items 142/200) is configured to hold the at least one electrode (figure 2a, item 250) fixed and stationary (figure 2b) relative to the electrode array insertion guide (figures 2a and 5a, items 202/220) while a cochlear electrode array (the examiner notes the “electrode array” is only functionally recited as being used with the claimed tool) is being moved through (functionally capable via lumen 224) the electrode array insertion guide (figures 2a and 5a, items 202/220).
[Claims 18 and 19] Gibson teaches the limitations of claim 17, upon which claims 18 and 19 depend. In addition, Gibson discloses the at least one electrode (figure 2a, item 250) comprises a plurality of electrodes (figures 2a/5a) mounted on an intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) of the electrode array insertion tool (figures 1 and 2a, items 142/200).
[Claim 20] Gibson teaches the limitations of claim 17, upon which claim 20 depends. Gibson further discloses the at least one electrode (figure 2a, item 250) is mounted on the electrode array insertion tool (figures 1 and 2a, items 142/200) such that the at least one electrode (figure 2a, item 250) is adjacent a lumen (figure 2b, item 224) of the electrode array insertion guide (figures 2a and 5a, items 202/220).
[Claim 21] Gibson teaches the limitations of claim 17, upon which claim 21 depends. Gibson also teaches the at least one electrode (figure 2a, item 250) is operable to provide stimulation to (paragraphs [0026], [0031]-[0033]) a recipient of the cochlear electrode array (figure 1, item 144) inserted by the electrode array insertion tool (figures 1 and 2a, items 142/200) or the cochlear electrode array (figure 1, item 144) inserted by the electrode array insertion tool (figures 1 and 2a, items 142/200) (paragraphs [0026], [0031]-[0033]).
[Claim 23] Gibson teaches the limitations of claim 17, upon which claim 23 depends. In addition, Gibson teaches the electrode array insertion guide (figures 2a and 5a, items 202/220) has an empty elongate hollow portion (figure 2b, item 224) through which an electrode array (see 112b interpretation above) (the examiner notes the “electrode array” is only functionally recited as being used with the claimed tool) is configured to move during insertion into a cochlea (figure 5a, item 115).
[Claim 24] Gibson teaches the limitations of claim 17, upon which claim 24 depends. Gibson also teaches the at least one electrode (figure 2a, item 250) is separate from electrodes of the cochlear electrode array (the examiner notes the “electrodes of an electrode array” is only functionally recited as being used with the claimed tool) insertable into a cochlea (figure 5a, item 115) using the electrode array insertion tool (figures 1 and 2a, items 142/200).
[Claim 25] Gibson teaches a surgical tool (figures 1 and 2a, items 142/200; paragraph [0029]) comprising:
an intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) configured to be inserted into a cochlea (figure 5a, item 115) of a recipient (figure 5a), wherein the intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) comprises an insertion lumen (figure 5a, item 224) configured to receive and to guide a stimulating assembly of an implantable medical device (the examiner notes the “stimulating assembly of an implantable medical device” is only functionally recited as being used with the claimed tool) into position within the cochlea (figure 5a, item 115),
wherein the intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) of the surgical tool (figures 1 and 2a, items 142/200) comprises one or more active electrical components (figure 2a, items 250/252).
[Claims 26 and 27] Gibson teaches the limitations of claim 25, upon which claims 26 and 26 depend. In addition, Gibson teaches the intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) comprises a sheath (figures 2a and 5a, items 202/220), and wherein the one or more active electrical components (figure 2a, items 250/252) form part of the sheath (figures 2a and 5a, items 202/220) (figures 2a/2b); wherein the one or more active electrical components (figure 2a, items 250/252) comprise a portion of a circuit (paragraph [0006]) formed on an outer surface (figures 2a/2b) of the sheath (figures 2a and 5a, items 202/220).
[Claims 28-30] Gibson teaches the limitations of claim 25, upon which claims 28-30 depend. Gibson also teaches the one or more active electrical components (figure 2a, items 250/252) comprises a plurality of electrodes (figure 2a, item 250) that are formed into two or more functional groups of electrodes (the examiner notes the claim limitation of a “functional group,” lacking any explicit definition within applicants’ specification or limitations in the claims, is arbitrary; as such, the electrodes taught by the prior art could easily be viewed as multiple “functional groups”), configured to generate an electric field (paragraph [0032]).
[Claims 31 and 32] Gibson teaches the limitations of claim 25, upon which claims 31 and 32 depend. Gibson further discloses the surgical tool (figures 1 and 2a, items 142/200) has an extra-cochlear portion (figure 5a; portion proximal to cochleostomy 152) that facilitates manipulation of the surgical tool (figures 1 and 2a, items 142/200) during surgery (paragraph [0042]) and wherein the intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) is configured for insertion through a round window (“cochleostomy”; figure 5a, item 152) of the cochlea (figure 5a, item 115) (figure 5a; paragraph [0042]).
[Claim 33] Gibson teaches the limitations of claim 25, upon which claim 33 depends. In addition, Gibson teaches the surgical tool (figures 1 and 2a, items 142/200) has at least one electrical connector (figure 1, via item 140) configured to electrically connect to the one or more active electrical components (figure 2a, items 250/252) (figure 1; paragraph [0026]).
Allowable Subject Matter
Claims 12 and 13 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.
Conclusion
THIS ACTION IS MADE FINAL. 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 JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 07/28/2026
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