DETAILED ACTION
Response to Arguments
Applicant's arguments filed 6/20/25 have been fully considered but they are not persuasive.
Applicant asserts Polak only discloses a recording electrode on or just under the scalp or forehead, rather than a recording electrode on the ABI electrode sheet itself. Examiner agrees Polak discloses a positive electrode of a recording electrode pair may be positioned on or just under the scalp or forehead of the patient. However, Polak also discloses the negative electrode of the recording electrode pair may be on the ABI electrode array itself (Paragraph 36: “Additionally, one of the electrodes in the electrode array 209 of the imlant…proximate the auditory brainstem…may be used, without limitation, as a negative electrode…The negative electrode may be an already existing electrode in the implant electrode array, such that it is used for stimulation during normal use of the implant, and for recording when measuring eABR.”).
Information Disclosure Statement
The information disclosure statement filed 12/13/21 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
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.
Claim(s) 10, 12, 13, 16, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Polak (US 2012/0029377).
PNG
media_image1.png
524
384
media_image1.png
Greyscale
Regarding claim 10, Polak discloses the same invention as claimed (Figure 2 shown above for example), including an electrophysiological test method for an auditory brainstem implant based on cochlear nucleus action potentials (abstract: response recorded from stimulation array), comprising: implanting an ABI electrode sheet (Paragraph 7); using any one of to-be-tested ABI electrodes on the ABI electrode sheet as a stimulating electrode to emit an electrical stimulation (abstract; Paragraph 37), using any other one of the ABI electrodes on the ABI electrode sheet as a recording electrode of the stimulating electrode, the recording electrode being configured to receive an electrical stimulation signal transmitted by the stimulating electrode and record electrically-evoked cochlear nucleus action potentials(abstract; Paragraph 36); determining whether an electrically-evoked cochlear nucleus action potential target waveform is obtained: if an electrically-evoked cochlear nucleus action potential target waveform is obtained, the stimulating electrode being correctly placed; and if an electrically-evoked cochlear nucleus action potential target waveform is not obtained, the stimulating electrode being incorrectly placed, performing fine-tuning on a position of the stimulating electrode, and performing steps S2 to S4 after the fine-tuning, until the electrically-evoked cochlear nucleus action potential target waveform is obtained (Paragraph 9); and determining whether all of the to-be-tested ABI electrodes on the ABI electrode sheet have been tested: if all of the to-be-tested ABI electrodes on the ABI electrode sheet have been tested, ending an electrophysiological test process; and if not, performing step S2, and testing a next one of the to-be-tested ABI electrodes until all of the to-be-tested ABI electrodes have been tested (Paragraph 9; see also Paragraph 46: testing typically concludes when all electrodes have been tested).
Regarding claims 12-13, Polak discloses standard placement of a standard ABI electrode as recited (Paragraph 9; Figure 2).
Regarding claims 16-17, Polak discloses automatically recognizing an evoked action potential target waveform as recited (Paragraph 9).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Grasso (US 2017/0224980) shows adjusting placement of ABI electrodes.
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 Eugene T Wu whose telephone number is (571)270-5053. The examiner can normally be reached M-F 8am-5pm.
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, Carl Layno can be reached on 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Eugene T Wu/Primary Examiner, Art Unit 3796
Prosecution Insights