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
This Action is in response to the Amendment filed April 08, 2026.
In view of the Amendment, the objections to most of the drawing issues and to all of the specification issues, as set forth in the 01/09/2026 Office Action, are withdrawn.
No amendments are made to the claims.
Claims 1-18, 34 and 40 are pending with claims 34 and 40 withdrawn from consideration.
Response to Arguments
Applicant's arguments filed April 8, 2026 have been fully considered but they are not persuasive.
In response to Applicant’s assertion that “Fung does not disclose ‘a measurement unit for measuring coil coupling strength values indicative of a received telemetry coupling strength (“MTEL-RSSI”) when the external transceiver coil and the implant transceiver coil are inductively coupled”, the use of a parenthetical phrase in the claims does not preclude another measuring unit that measures values indicative of telemetry coupling strength. “MTEL” can be short for Massachusetts Tests for Educator Licensure, which does not add information to the claim. While the specification indicates that the received coil telemetry coupling strength is also labeled “MTEL-RSSI hereinafter” (i.e., paragraph [0047] of US 2024/0196137, the instant application’s PG-Pub), it is unclear to what the acronym “MTEL-RSSI” refers in the claim. Moreover, under the BRI, Fung’s measured values are indicative of coupling strength (e.g., Abstract: a wearable component of an implantable medical device is adapted to work with a sensor that detects the strength of the magnetic field emanating from a magnet situated in the implanted portion of the device that can be programmed or adjusted to the required strength; and paragraphs [0021]-[0022]: an active medical implant with an transcutaneous data and/or power link align implanted and external magnets to one another and the internally and externally situated radiofrequency coils where the effectiveness of such an induction link is sensitive to the placement the two coils – a loose magnet connection would have an ineffective induction link; [0055]: sensor 419 measures the field strength of the internal magnet 415 as felt at the recipient’s skin; and [0057]: where the sensor is part of a clinical tool or is integrated into an external portion of the implantable device and the clinical tool receives and processes magnetic field strength readings). That is, Fung’s measured values reflects the quality of the inductive link using a technology discussed in paragraphs [0005]-[0009] of the instant specification, which is the corresponding structure of the “measurement unit” under 35 USC 112(f) (see below) .
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the received coil telemetry coupling strength is a parameter derived from the inductive RF coupling behavior between transceiver coils) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The Examiner further notes that Fung also discloses an analyzing unit that outputs an estimation of a present transcutaneous magnetic coupling strength between the implant attachment magnet device and the external magnet device (e.g., previously cited/applied paragraphs [0057]: computer 441 is the analyzing unit where clinical programming tool 431 receives and processes magnetic field strength readings from the sensor, and the clinical programming tool communicates with a computer 441 that provides electrical signals to the magnetizing coil to adjust the strength of the external magnet; and [0058]: computing device 441 controls the fitting process of the implant).
In addition, US 2020/0215328 to Young et al., previously cited of interest, is directed to system and methods for facilitating optimal alignment of cochlear implant system components where the cochlear implant and sound processor generate a Received Signal Strength Indicator (RSSI) (e.g., abstract and paragraph [0016]). Thus, it was known in the hearing prosthesis art to measure a Received Signal Strength Indicator (RSSI) signal based on the signal strength of the wireless back telemetry signal. Since the claims do not positively recite this feature, it is not necessary to apply this reference at this time.
Priority
Claims 1-18 are deemed to have an effective filing date of April 16, 2021.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: ear hook.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “measurement unit” and “analyzing unit” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. “measurement unit for measuring coil coupling strength value…inductively coupled” in claim 1 and all its dependent claims: For this limitation, specification discloses where it is located (headpiece or sound processor) and what it measures in the Abstract and paragraph [0047] of the PGPub does not discuss the corresponding structure, but discloses prior art that use such measurement units in paragraphs [0005]-[0009].
“analyzing unit configured to control…the external attachment magnetic device.” in claim 1 and all its dependent claims: For this limitation, paragraph [0066] of the PGPub seems to disclose corresponding structure.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 1-3, 11 and 13-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2018/0352349 to Fung et al. (hereinafter referred to as “Fung”).
Regarding claim 1, Fung discloses a hearing prosthesis system (e.g., Abstract: an auditory prosthesis) comprising a hearing implant implantable within a patient and including an implant transceiver coil and an implant attachment magnet device (e.g., paragraphs [0020]-[0022]: audio prostheses rely on a magnetic coupling between an external (wearable) component and an internal component where the internal and external components both include a magnet and radiofrequency coils that provide an induction link and paragraph [0030]); an external component including an external transceiver coil and an external attachment magnet device (e.g., paragraphs [0020]-[0022]: audio prostheses rely on a magnetic coupling between an external (wearable) component and an internal component where the internal and external components both include a magnet and radiofrequency coils that provide an induction link and paragraph [0030]), wherein the external component comprises or is connected to a measurement unit for measuring coil coupling strength values indicative of a received coil telemetry coupling strength (“MTEL-RSSI”) when the external transceiver coil and the implant transceiver coil are inductively coupled (e.g., Abstract: a wearable component of an implantable medical device is adapted to work with a sensor that detects the strength of the magnetic field emanating from a magnet situated in the implanted portion of the device; and paragraphs [0055]: sensor 419 measures the field strength of the internal magnet 415 as felt at the recipient’s skin; and [0057]: where the sensor is part of a clinical tool or is integrated into an external portion of the implantable device); and an analyzing unit configured to control the measurement unit, to receive coil coupling strength values measured by the measurement unit and to analyze the received coil coupling strength values (e.g., paragraphs [0057]: computer 441 is the analyzing unit where clinical programming tool 431 receives and processes magnetic field strength readings from the sensor, and the clinical programming tool communicates with a computer 441 that provides electrical signals to the magnetizing coil to adjust the strength of the external magnet; and [0058]: computing device 441 controls the fitting process of the implant) so as to output at least one of an estimation of a present transcutaneous distance between the implant transceiver coil and the external transceiver coil (e.g., paragraph [0080]: the magnetic field strength of the internal portion is measured by the sensor (and hence the thickness of the skin flap can be estimated) – i.e., an estimation of a present transcutaneous distance between the implant and the external coil can be output), an estimation of a present transcutaneous magnetic coupling strength between the implant attachment magnet device and the external attachment magnet device (e.g., paragraph [0080]: after the external RF coil is coupled to the internal RF coil, the magnetic field strength at external RF coil due to internal magnet is measured and can be output), and a target value of the transcutaneous magnetic coupling strength for adjusting the transcutaneous magnetic coupling strength between the implant attachment magnet device and the external attachment magnet device (e.g., paragraphs [0009], [0058]-[0059]: computing device 441 receives the magnetic field strength felt by the external portion that is attributable to the internal magnet and calculates a desired magnetic field strength, or a range of magnetic field strengths for the external magnet and communicates instructions to adjust the strength of the external magnet).
With respect to claim 2, Fung discloses the system of claim 1, wherein the analyzing unit is configured to cause the measurement unit to measure a series of coil coupling strength values while the external component moves from a magnetically decoupled starting position above the patient's skin towards the hearing implant into a magnetically attached end position on the skin by magnetic coupling forces between the implant attachment magnet device and the external attachment magnet device (e.g., paragraph [0080]: before coupling, a magnetic strength value is measured and after coupling, another magnetic strength value is measured).
As to claim 3, Fung discloses the system of claim 2, wherein the analyzing unit is configured to cause the measurement unit to repeatedly measure a series of coil coupling strength values while the external component moves from a magnetically decoupled starting position above the skin towards the hearing implant into a magnetically attached end position on the skin by magnetic coupling forces between the implant attachment magnet device and the external attachment magnet device, so as to obtain a plurality of series of coil coupling strength values (e.g., paragraphs [0057] and [0080]-[0081]: when the measurement unit is part of the external implantable medical system, a measurement is made while the external component moves from a magnetically decoupled starting position above the skin towards hearing implant where another measurement occurs when external and internal components are coupled).
With respect to claim 11, Fung discloses the system of claim 2, wherein the analyzing unit is configured to provide for an estimation of a transcutaneous magnetic coupling strength between the implant attachment magnet device and the external attachment magnet device by analyzing the measured series of coil coupling strength values, or the measured plurality of series of coil coupling strength values, respectively (e.g., paragraph [0080]; analyzes the measured series of coil coupling strength values).
As to claim 13, Fung discloses the system of claim 11, wherein the analyzing unit is configured to provide for an estimation of a present transcutaneous magnetic coupling strength between the implant attachment magnet device and the external attachment magnet device by using the estimation of the present transcutaneous distance between the implant transceiver coil and the external transceiver coil (e.g., paragraph [0081]: the in-built magnetic field sensor reading is proportional to the separation of the two magnets (distance) and thus, is an indicator of skin-flap thickness).
With respect to claim 14, Fung discloses the system of claim 1, wherein the external component comprises a unit for adjusting a magnetic coupling strength contribution of the external attachment magnet device (e.g., paragraphs [0009]: clinical programming system adjusts the field strength of the external magnet in order to achieve the recommended magnetic strength; [0049]: in some external devices, micro adjustments of the magnet position can be made via a screw to alter the distance between magnets).
As to claim 15, Fung discloses the system of claim 14, wherein the unit for adjusting the magnetic coupling strength contribution of the external attachment magnet device is configured to activate or deactivate one more electropermanent magnets or to move the external attachment magnet device within the external component so as to adjust the transcutaneous distance between the external attachment magnet device and the implant attachment magnet device (e.g., paragraph [0049]).
With respect to claim 16, Fung discloses the system of claim 14, wherein the unit for adjusting the magnetic coupling strength contribution of the external attachment magnet device (clinical programming tool) is configured to be controlled by the target value provided by the analyzing unit (computing device), so as to optimize the magnetic coupling strength between the external attachment magnet device and the implant attachment magnet device when the external component is attached to the patient's skin (e.g., paragraphs [0009], [0059], and [0032]: as described herein, it is possible to optimize the magnetic field strength of the external magnet to achieve better placement).
As to claim 17, Fung discloses the system of claim 1, wherein the analyzing unit is implemented in a device which is separate from the external component and which configured to be communicatively coupled to the external component (e.g., paragraph [0055]-[0057]: analyzing unit is the computing device 441, which communicates with the external component via clinical programming tool 431 and sensor 419 that is separate from the external component but communicates with the external component).
With respect to claim 18, Fung discloses the system of claim 17, wherein the analyzing unit is implemented in at least one of a fitting device, a mobile phone, a tablet computer, or a computing cloud (e.g., Abstract: determination of magnetic strength can now be an automated step in the process of fitting an auditory prosthesis).
Claim Rejections - 35 USC § 103
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.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Fung as applied to claim 3 above, and further in view of US Patent No. 7,450,994 to Mishra et al. (hereinafter referred to as “Mishra”).
Fung discloses the system of claim 3, but does not expressly disclose that the analyzing unit is configured to conduct a statistical analysis over the measured series of coil coupling strength values or over the measured plurality of series of coil coupling strength values, respectively. However, Mishra, in a related art: estimated flap thickness for cochlear implant, teaches that statistical methods (such as a median [or an averaging procedure]) may be used to calculate a value to estimate the flap thickness or distance from the internal component to the external component of the cochlear implant system (e.g., column 8, lines 30-42 of Mishra). Accordingly, one of ordinary skill in the art would have recognized the benefits of conducting a statistical analysis of the measured series of coil coupling strengths in view of the teachings of Mishra. Consequently, one of ordinary skill in the art would have modified the system of Fung so that its analyzing unit conducts an averaging statistical procedure when analyzing the received coil coupling strengths in view of the teachings of Mishra that such was a well-known engineering protocol in the cochlear implant art, and because the combination would have yielded a predictable result.
Claims 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Fung as applied to claim 3 above, and further in view of US Patent Application Publication No. 2007/0100395 to Ibrahim and Mishra.
With respect to claim 6, Fung discloses the system of claim 3, but does not expressly teach that the analyzing unit is configured to fit a model function or a parametric model to the measured series of coil coupling strength values or to an averaged series of coil coupling strength values, so as to determine a slope and/or an amplitude of the model function or parametric model. However, Ibrahim, in a related art: method and apparatus for measurement of transmitter/receiver separation, teaches that a best-fit algorithm or model may be derived from the measured voltage/distance values for use in converting magnetic field strengths to estimated transceiver separation where the magnetic field is proportional to reactive power and stimulation parameters have an effect on the peak amplitude of the magnetic field (e.g., paragraphs [0088], [0093], [0128] of Ibrahim), and Mishra teaches that using coupling strength voltage vs distance graph with a slope and amplitude to determine an estimated separation distance using magnetic coupling voltage values, or vice versa (e.g., column 8, lines 30-42 and Fig. 5 of Mishra). Accordingly, one of ordinary skill in the art would have recognized the benefits of the analyzing unit fitting a model function to the measured series of coil coupling strengths in view of the teachings of Ibrahim, and the benefits of such an analyzing unit where a slope and/or amplitude of the model function is determined in view of the teachings of Mishra. Consequently, one of ordinary skill in the art would have modified the system of Fung so that its analyzing unit is configured to fit a model function so as to determine a slope and/or amplitude of the model function in view of the teachings of Ibrahim and Mishra that such were well-known engineering protocols in the cochlear implant art, and because the combination would have yielded a predictable result.
As to claim 7, Fung in view of Ibrahim and Mishra teaches the system of claim 6, wherein the analyzing unit is configured to provide an estimation of the present transcutaneous distance between the implant transceiver coil and the external transceiver coil by using a predetermined relationship between the coil coupling strength values and the distance between the implant transceiver coil and the external transceiver coil (e.g., Fung paragraphs [0080]: as above; [0025]: a predetermined relationship exists between coil coupling and the distance between the implant coil and the external coil) .
With respect to claim 8, Fung in view of Ibrahim and Mishra teaches the system of claim 7, wherein the analyzing unit is configured to provide an estimation of the present transcutaneous distance between the implant transceiver coil and the external transceiver coil from the amplitude determined from the fitting of the model function or parametric model (e.g., paragraph [0101] of Ibrahim; and column 8, lines 30-42 of Mishra: voltage is plotted with the horizontal lines of the graph and point of intersection of these lines with the calibration line is the estimated flap thickness where the amplitude determined from the fitting determines the distance). Accordingly, one of ordinary skill in the art would have recognized that the amplitudes of the measured and reference signals have a relationship with the separation between transmitter coil and receiver coil in view of the teachings of Ibrahim and Mishra. Consequently, one of ordinary skill in the art would have modified the system of Fung in view of Ibrahim and Mishra so that the analyzing unit is configured to provide an estimation of transcutaneous distance between internal and external coils from the amplitude determined from the fitting of the model function in view of the teachings of Ibrahim and Mishra that such were well-known engineering protocol for determining estimation of distance in the cochlear implant art, and because the combination would have yielded a predictable result.
As to claim 9, Fung in view of Ibrahim and Mishra teaches the system of claim 7, wherein the analyzing unit is configured to provide an estimation of the present transcutaneous distance between the implant transceiver coil and the external transceiver coil from an average of those coil coupling strength values of the measured series which are capable of being constant within a given range (e.g., column 8, lines 30-42 of Mishra).
With respect to claim 10, Fung in view of Ibrahim and Mishra teaches the system of claim 7, wherein the analyzing unit is configured to estimate a thickness of the skin located between the hearing implant and the external component from the estimation of the present transcutaneous distance between the implant transceiver coil and the external transceiver coil (e.g., paragraphs [0080]-[0081] of Fung).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Fung as applied to claim 11 above, and further in view of Mishra.
With respect to claim 12, Fung discloses the system of claim 11, wherein the analyzing unit is configured to provide for an estimation of a transcutaneous magnetic coupling strength between the implant attachment magnet device and the external attachment magnet device, but does not expressly disclose that the estimation is achieved by analyzing at least one of (i) a slope of the coil coupling strength values in the measured series of coil coupling strength values or in the measured plurality of series of coil coupling strength values, (ii) a variance of the coil coupling strength values in the measured series of coil coupling strength values or in the measured plurality of series of coil coupling strength values, and (iii) an amplitude of the coil coupling strength values in the measured series of coil coupling strength values or in the measured plurality of series of coil coupling strength values. However, Mishra teaches that using a coupling strength voltage vs distance graph with a slope and amplitude to determine an estimated separation distance using magnetic coupling voltage values, or vice versa (e.g., column 8, lines 30-42 and Fig. 5 of Mishra). Accordingly, one of ordinary skill in the art would have recognized the benefits of the analyzing unit where a slope and/or amplitude of the coil coupling strength graph determines an estimated coupling strength in view of the teachings of Mishra. Consequently, one of ordinary skill in the art would have modified the system of Fung so that its analyzing unit is configured to analyze a slope and/or amplitude of the magnetic coupling graph to determine a coupling strength estimation in view of the teachings of Mishra that such were well-known engineering protocols in the cochlear implant art, and because the combination would have yielded a predictable result.
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 CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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, Unsu Jung can be reached at 571 272-8506. 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.
/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792
Prosecution Insights