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 Arguments
Applicant's arguments filed 08 December 2026 have been fully considered but they are not persuasive. Applicant argues that Wissenwasser fails to teach obtaining telemetry data indicating an inductive coupling between a test coil assembly inserted into the ear canal of the recipient and the at least one implantable coil. In the cited paragraphs, Wissenwasser teaches that the AIMD system comprises implanted communications coil arrangements. In ¶ 4 of Wissenwasser, it is taught that AIMD systems use an inductive communication coil arrangements. This reads on the claims as presently presented. It is noted that the claim recites “at least one implantable coil configured to be positioned adjacent to an ear canal of the recipient.” The phrase “adjacent to an ear canal” is broad. The coil must just be sized to be capable to be implanted and be near the ear canal to be considered to be adjacent. If the coil is placed on the skin of the patient, it would be considered to be “adjacent to an ear canal of the recipient.”
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.
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.
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.
Claim(s) 1 – 12, 14 – 18, and 41 – 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spearman et al. (US PGPUB 2016/0183018 – in IDS) in view of Hatzilias et al. (US PGPUB 2015/0097935 – in IDS) and Wissenwasser et al. (US PGPUB 2016/0310735 – in IDS).
Regarding claims 1 and 41, Spearman discloses a method and non-transitory computer readable storage media, with instrutions, comprising: obtaining anatomical data (e.g. ¶ 16) and determining, based at least on the data, an optimal placement for the ITE coil in the ear canal for operation with the at least one implantable coil (e.g. ¶ 16 and 57). Spearman does not specifically recite that the anatomical data
obtaining anatomical data associated with an outer ear of a recipient of an implantable auditory prosthesis comprising at least one implantable coil configured to be positioned adjacent to an ear canal of the recipient for operation with an in-the-ear (ITE) coil or obtaining telemetry data indicating an inductive coupling between a test coil assembly inserted into the ear canal of the recipient and the at least one implantable coil.
Hatzilias teaches it is known to obtain anatomical data associated with an outer ear of a recipient of an implantable auditory prosthesis comprising at least one implantable coil configured to be positioned adjacent to an ear canal of the recipient for operation with an in-the-ear (ITE) coil (e.g. ¶ 17). It would have been obvious to one having ordinary skill in the art to modify the anatomical data as taught by Spearman with the anatomical data as taught by Hatzilias to better create three dimensional reconstructions of the ear canal to better customize in-ear devices.
Furthermore, Wissenwasser teaches it is known to obtain telemetry data indicating an inductive coupling between a test coil assembly inserted into the ear canal of the recipient and the at least one implantable coil (e.g. ¶ 8 – 10). It also would have been obvious to one having ordinary skill in the art to modify the invention as taught by Spearman in view of Hatzilias with the telemetry data as taught by Wissenwasser, since the telemetry data may be used to more effectively determine coil arrangement.
Regarding claims 2, 3, 42, and 43, modified Spearman teaches the claimed invention, except for performing a three-dimensional (3D) imaging scan of the outer ear of the recipient and obtaining medical imaging of the outer ear of the recipient.
Hatzilias teaches it is known to perform a three-dimensional (3D) imaging scan of the outer ear of the recipient (e.g. ¶ 17). It would have been obvious to one having ordinary skill in the art to modify the anatomical data as taught by Spearman with the anatomical data as taught by Hatzilias to better create three dimensional reconstructions of the ear canal to better customize in-ear devices.
Regarding claims 4 – 9 and 44, modified Spearman discloses the claimed invention except for performing the RF scans of the ear canal at different orientations.
Wissenwasser describes this process of obtaining the telemetry data (e.g. ¶ 15 – 18). It would have been obvious to one having ordinary skill in the art to modify the invention as taught by Spearman in view of Hatzilias with the telemetry data as taught by Wissenwasser, since the telemetry data may be used to more effectively determine coil arrangement.
Regarding claims 10 and 14, Spearman discloses determining a selected location of the ITE coil in the ear canal and a selected orientation of the ITE coil relative to the at least one implantable coil (e.g. ¶ 16 and 57).
Regarding claims 11, 12, 45, and 46, modified Spearman discloses the claimed invention except for generating at least one of a real-time audible or real-time visible representation of the telemetry data; generating a real-time visible representation of a position of the test coil assembly within the ear canal; and determining the optimal placement based on the at least one of the real-time audible or real-time visible representation of the telemetry data and the real-time visible representation of a position of the test coil assembly within the ear canal.
However, Hatzilias teaches it is known to use a display screen to show real-time constructions of three-dimensional images corresponding to the scanned cavity (e.g. ¶ 27). This would read on this limitation. It would have been obvious to one having ordinary skill in the art to modify the invention of Spearman with the real time display as taught by Hatzilias, since such a modification would provide the predictable results of a modification would provide the predictable results of aiding the operator to effectively align the device.
Regarding claims 15, 16, 47, and 48, Spearman discloses forming an ITE component comprising a body and ITE coil for insertion into the ear canal, wherein the ITE component has an arrangement such that, when the body is inserted into the ear canal, the ITE coil will be situated at the optimal placement and wherein the body comprises an ear mold, and wherein forming the ITE component comprises: forming the ear mold based on the anatomical data and the telemetry data (e.g. ¶ 8 – 11).
Regarding claims 17, 18, and 49, Spearman discloses forming the ear mold based on the anatomical data and the telemetry data comprises: rendering, at a computing device, a three-dimensional (3D) model of the ear mold; and manufacturing the ear mold from the 3D model of the ear mold rendered at the computing device and wherein forming the ITE component comprises: injecting a direct ear impression material into the ear canal around the ITE coil situated at the optimal placement (e.g. ¶ 55 – 56).
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 JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796
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