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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-18 in the reply filed on 06/18/2026 is acknowledged.
Claims 19 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/18/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/29/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 3 is objected to because of the following informalities: the phrase “the transmitting the optical signal…” is grammatically incorrect and should be amended to recite “the transmission of the optical signal…”. Appropriate correction is required.
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.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Riis et al. (US 20190321655)(Hereinafter Riis).
Regarding claim 1, Riis teaches A cochlear implant system (Abstract “A cochlear implant hearing aid system”) comprising:
a cochlear implant comprising a first optical element configured to be implanted within a recipient and positioned toward an inner surface of a skin flap of the recipient (Fig. 9B [0061] “where transmitting NIR LEDs are embedded on the back of a CI implant device.” [0063] “a behind the ear (BTE) hearing aid” [0111] “the LED(s) (i.e. near-infrared transmitter) is/are placed below the skin and the detector (i.e. near-infrared receiver) is placed outside the head.” The device is implanted and must be within a user/recipient, and specifically in an inner surface of a skin flap as that is the location opposite of the BTE.); and
a processing unit communicatively coupled with the cochlear implant and configured ([0061] “where transmitting NIR LEDs are embedded on the back of a CI implant device. NIR sensors located at the back of the implant can detect reflected NIR light and the implant processor (e.g. a digital signal processor (DSP)) can process the signals”) to:
cause an optical signal transmission between the first optical element and a second optical element included in an external device and configured to be positioned toward outer surface of the skin flap relative to the first optical element, the optical signal transmission including a transmission of an optical signal through the skin flap between the inner surface and the outer surface of the skin flap (Fig. 9B shows that the LED on the implant can transmit optical signal to the external device. [0011] “The near-infrared transmitter may be an internal near-infrared transmitter provided on said implant part and configured to transmit said near-infrared wave towards a cortex of said user.” [0016] “the external near-infrared receiver may be configured to receive said near-infrared wave directly from said internal near-infrared transmitter.” [0111] “the LED(s) (i.e. near-infrared transmitter) is/are placed below the skin and the detector (i.e. near-infrared receiver) is placed outside the head.” Examiner notes that the claim fails to actively recite the external device with the second optical element.); and
determine, based on the optical signal transmission, one or more properties associated with the skin flap of the recipient ([0100] “The channel properties are fixed after determining the optimal light wavelength and by the thickness [property associated with the flap] of a given skin flap so theoretical calculations of these can be done.” [0049] changes in oxygenated hemoglobin (HbO), which measure an expected increase of concentration due to the augmented blood supply required by the neuronal activation, and [0050] deoxygenated hemoglobin (HbR), which is predicted to decrease due to increased oxygen consumption occurring at the cortical site of activation.”).
Regarding clam 2, Riis teaches wherein one of the first optical element or the second optical element includes an optical emitter configured to transmit the optical signal ([0011] “The near-infrared transmitter may be an internal near-infrared transmitter provided on said implant part and configured to transmit said near-infrared wave towards a cortex of said user.”).
Regarding claim 3, Riis teaches wherein the transmitting the optical signal includes modulating the optical signal ([0102] “All IR-based modulation techniques demonstrated a sufficient bit-rate to meet the 320 kbps required (based on a channel permitting pulse widths of 125 ns which is an IrDA standard pulse width)” The instant specification discloses that modulation may be pulses.).
Regarding claim 4, Riis teaches wherein the optical emitter includes one or more light-emitting diodes (LEDs) ([0061] “where transmitting NIR LEDs are embedded on the back of a CI implant device.”).
Regarding claim 5, Riis teaches wherein the one or more LEDs are multispectral ([0096] “Current technologies for brain imaging (fNIR) have adopted using IR wavelengths. Generally, these wavelengths are 810 or 840 nm in the ‘near’ infra-red spectrum (700-900 nm). The advent of this technology has increased the availability of LEDs and photodiodes that produce and receive these wavelengths for medical applications.”).
Regarding claim 6, Riis teaches wherein the first optical element is positioned at one or both of an antenna or a magnet included in the cochlear implant ([0114] “where the data is return on a high rate light channel, sent on a high rate light channel and only power is delivered on the Magnetic channel.” [0087] “The magnetic link also provides any other required data to be returned from e.g. the implant of a CI to the BTE.” See Fig. 9B where the implanted device includes the magnetic channel with the optical channel.).
Regarding claim 7, Riis teaches wherein one of the first optical element or the second optical element includes an optical sensor configured to attempt to detect the optical signal during the optical signal transmission ([0016] “the external near-infrared receiver may be configured to receive said near-infrared wave directly from said internal near-infrared transmitter.” [0074] “The physical distance between the LED and the photodiode determine the depth of penetration of the NIR signal.” The receiver must be the photodiode to receive the transmitted light from the LED.).
Regarding claim 8, Riis teaches wherein the optical sensor comprises one or more of a camera, a charged-coupled device (CCD), or a photodetector ([0074] “The physical distance between the LED and the photodiode determine the depth of penetration of the NIR signal.”).
Regarding claim 9, Riis teaches wherein the external device includes a headpiece of the cochlear implant system and configured to be worn by the recipient ([0063] “behind the ear (BTE) hearing aid” [0079] “The cochlear implant hearing aid system 10 comprises an external part 11 and an implant part 12.” Examiner notes that the external device must be externally worn because the transfer of light, between an LED and photodiode, must be close to one another to be capable of measuring the skin tissue.).
Regarding claim 10, Riis teaches wherein the second optical element is positioned at one or both of an antenna or a magnet included in the headpiece ([0114] “where the data is return on a high rate light channel, sent on a high rate light channel and only power is delivered on the Magnetic channel.” [0087] “The magnetic link also provides any other required data to be returned from e.g. the implant of a CI to the BTE.” See Fig. 9B where the headpiece includes the magnetic channel with the optical channel.).
Regarding claim 11, Riis teaches wherein the second optical element is aligned with the first optical element when the headpiece is magnetically coupled to the cochlear implant in any rotational position of the headpiece relative to the cochlear implant (Examiner notes that the independent claim does not actively recite the positioning of the second optical element.).
Regarding claim 12, Riis teaches wherein the external device is separate from the cochlear implant system (Fig. 6-7, and 9).
Regarding claim 13, Riis teaches wherein the processing unit is included in a sound processor of the cochlear implant system ([0083] “The external part 11 includes a sound pickup unit 11a configured to pick up sound from the environment and a sound processing unit 11b configured to process said sound.” Examiner notes that the independent claim does not limit the location of the processing unit.).
Regarding claim 14, Riis teaches wherein the one or more properties associated with the skin flap include one or more of a thickness, a blood oxygenation, a pulse rate, a blood vessel size, a blood flow, a blood perfusion, or a blood pressure ([0100] “The channel properties are fixed after determining the optimal light wavelength and by the thickness [property associated with the flap] of a given skin flap so theoretical calculations of these can be done.” [0048] “There are two different useful responses: [0049] changes in oxygenated hemoglobin (HbO), which measure an expected increase of concentration due to the augmented blood supply required by the neuronal activation, and [0050] deoxygenated hemoglobin (HbR), which is predicted to decrease due to increased oxygen consumption occurring at the cortical site of activation.”).
Regarding claim 15, Riis teaches wherein the determining the one or more properties is based on one or more of an absorption of the optical signal or a change of intensity of the optical signal between the inner surface and the outer surface of the skin flap during the optical signal transmission ([0048] “There are two different useful responses: [0049] changes in oxygenated hemoglobin (HbO), which measure an expected increase of concentration due to the augmented blood supply required by the neuronal activation, and [0050] deoxygenated hemoglobin (HbR), which is predicted to decrease due to increased oxygen consumption occurring at the cortical site of activation.” Examiner notes that the capability of measuring the changes in in concentration is due to the absorption of the IR wavelength of oxygenated blood, and absorption of the red wavelength of deoxygenated blood.).
Regarding claim 16, Riis teaches wherein the determining the one or more properties includes determining a change in the one or more properties relative to a baseline associated with the one or more properties ([0048] “There are two different useful responses: [0049] changes in oxygenated hemoglobin (HbO), which measure an expected increase [relative to baseline] of concentration due to the augmented blood supply required by the neuronal activation, and [0050] deoxygenated hemoglobin (HbR), which is predicted to decrease due to increased oxygen consumption occurring at the cortical site of activation.”).
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.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riis et al. (US 20190321655)(Hereinafter Riis) in view of Gibson et al. (US 20230338736)(Hereinafter Gibson).
Regarding claim 17, Riis teaches the invention of claim 1. However, Riis does not teach the providing a notification associated with the change in the one or more properties. Gibson, in the same field of endeavor, teaches an implanted cochlear device with an external device for diagnosing vestibular conditions (Abstract), and further teaches further comprising providing a notification associated with the change in the one or more properties ([0107] “For example, operation 259 can include generating an alert indicating a potential issue with the recipient's vestibular system or the recipient's cochlea based on both the cochlear biological state data 211 and the vestibular biological state data 221.”) to allow a physician to take appropriate action ([0107]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Riis, with the providing a notification associated with the change in the one or more properties of Gibson, because such a modification would allow to allow a physician to take appropriate action.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riis et al. (US 20190321655)(Hereinafter Riis) in view of Gustafsson et al. (US 20180160241)(Hereinafter Gustafsson).
Regarding claim 18, Riis teaches the invention of claim 1. However, Riis does not teach the decreasing of the magnet strength in the cochlear implant system. Gustafsson, in the same field of endeavor, teaches a cochlear implanted hearing aid device with magnets and implanted device ([0036]), and further teaches further comprising decreasing a strength of one or more magnets included in the cochlear implant system ([0061] “Due to variations in skin flap thickness (the distance between a top surface of the magnet implanted in the recipient and the outer surface of the skin), there can be utilitarian value with respect to varying the strength of the magnetic field generated by the magnet(s) of the external component 540.” Examiner notes that this limitation is intended use, and does not disclose what structure is configured to do this function.) to adjust the strength based on the flap thickness ([0061]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Riis, with the decreasing of the magnet strength in the cochlear implant system of Gustafsson, because such a modification would allow to adjust the strength based on the flap thickness.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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