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 Office Action is responsive to the Amendment filed 27 May 2026. Claims 1-25 are now pending. The Examiner acknowledges the amendments to claims 1 and 25.
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, 2, 10-17, 20, 21 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johansson (US 20130245363 A1).
Regarding claim 1, Johansson teaches a semi-implantable hearing device (“listening device may be magnetically attached…form a hearing aid”, paragraph [0011]) comprising:
A replaceable outer ear unit (“transducer casing 25 is attached by way of the magnetic means”, paragraph [0041]; transducer casing 25 is detachable, shown in annotated Fig. 3 below) having an energy transfer device for generating energy responsive to acoustic energy (“microphone 33 is connected to the transducer through signal transmission…ensure efficient and low loss transmission of the acoustic energy”, paragraph [0045]; microphone 33, Fig. 7) received by the replaceable outer ear unit, the replaceable outer ear unit being adapted to be located inside a subject’s outer ear canal or behind a subject’s ear (“placement of the transmission area behind the outer ear”, paragraph [0045]; transducer casing 25 behind subject’s ear shown in Fig. 7); and
A fluid-filled tube-shaped device (“liquid conduction means is shaped as a tube 20”, paragraph [0037]; liquid filled tube 20, shown in annotated Fig. 3 below), separate from the replaceable outer ear unit (liquid filled tube 20 is separate from the detachable transducer casing 25 in Fig. 3), that is placed in the middle ear (“liquid conducting means 20…situated next to the cochlea 3 within the middle ear”, paragraph [0055]; liquid filled tube 20 shown in middle ear in Fig. 3) or mastoid, the fluid-filled tube-shaped device adapted to receive transferred energy from the replaceable outer ear unit through the tympanic membrane (“sound input path…through the ear canal 10, the tympanic membrane 11, via the middle ear ossicles”, paragraph [0035]; the middle ear is the tympanic membrane where energy is being transferred from the outer ear unit to the tube device) wherein energy received by the fluid-filled tube-shaped device is transferred to a subject’s inner ear via fluid contained in the fluid-filled tube-shaped device (“transmitting said vibrational signal through the skin and through a subcutaneous transition area and into a fluid or semi-fluid conduct…transmitting said sound signal into the cochlear”, claim 14).
PNG
media_image1.png
332
447
media_image1.png
Greyscale
Regarding claim 2, Johansson teaches the fluid-filled tube-shaped device including the fluid enclosed by a closed flexible tube (“medium 21 is a fluid medium, a membrane 24 which acts to separate the medium from the tissue…membrane should ideally be flexible”, paragraph [0038]).
Regarding claim 10, Johansson teaches the fluid-filled tube-shaped device being secured by attaching the fluid filled tube to the ossicular chain in the subject’s ear (“sound input path to the cochlear going through the ear canal 10, the tympanic membrane 11, via the middle ear ossicles 12, 13, 14”, paragraph [0035]; fluid filled tube shown attached to the ossicular chain in annotated Fig. 3 below).
PNG
media_image2.png
329
360
media_image2.png
Greyscale
Regarding claim 11, Johansson teaches the replaceable outer ear unit being hermetically sealed and implanted in a subject’s body (“in order to ensure constant contact between the transducer and the outer skin surface…corresponding implanted magnets, the device may attach to a skin portion of the user”, paragraph [0051]).
Regarding claim 12, Johansson teaches the fluid-filled tube-shaped device being configured to make inner ear contact by contacting the round window membrane (“size of transition area will be around the same size as the oval or round window on the cochlear”, paragraph [0041]; fluid-filled tube-shaped device contacting the round window membrane shown in annotated Fig. 3 below).
PNG
media_image3.png
344
360
media_image3.png
Greyscale
Regarding claim 13, Johansson teaches the fluid-filled tube-shaped device being configured to make inner ear contact by contacting the oval window or one or more ossicle (paragraph [0041], fluid-filled tube-shaped device contacting the round window membrane shown in annotated Fig. 3 above; paragraph [0035], tube-shaped device in contact with one or more ossicle shown in annotated Fig. 3 above).
Regarding claim 14, Johansson teaches the fluid-filled tube-shaped device being configured to make inner ear contact through a surgically or disease-created opening into the inner ear (“first part of the…tube 20…run through…a groove on the outside of the skull bone…could simplify surgery”, paragraph [0044]; liquid filled tube 20 shown surgically run through groove on the outside behind subject’s ear in order to make inner ear contact with the cochlea in Fig. 3).
Regarding claim 15, Johansson teaches the fluid-filled tube-shaped device being configured to make outer contact with the tympanic membrane (liquid filled tube 20 shown passing the tympanic membrane to the cochlea in annotated Fig. 3 below).
PNG
media_image4.png
340
398
media_image4.png
Greyscale
Regarding claim 16, Johansson teaches the fluid-filled tube-shaped device being configured to make outer contact under skin of the subject’s ear canal (liquid filled tube 20 shown making outer contact under skin of the subject’s ear canal in Fig. 3).
Regarding claim 17, Johansson teaches the fluid-filled tube-shaped device being configured to make outer contact under skin behind or above the ear (liquid filled tube 20 shown making outer contact under skin behind and above the ear in Fig. 3).
Regarding claims 20 and 21, Johansson teaches the fluid-filled tube-shaped device being used for transmitting hearing information (“transmitting said vibrational signal through said fluid conduct to the cochlear…transmitting said sound signal into the cochlear”, paragraph [0012]) where the fluid-filled tube-shaped device can be placed through the tympanic membrane and where the fluid-filled tube-shaped device traverses the tympanic membrane (“vibrations will travel through…and reach the cochlear…sound input path to the cochlear going through the ear canal 10, the tympanic membrane 11”, paragraph [0035]).
Regarding claim 23, Johansson teaches the fluid-filled tube-shaped device being used for transmitting hearing information where the fluid-filled tube-shaped device being secured using screws (“tube 20 is seated in a holder plate 34…plate 34 may be fastened in the bone tissue 2 by means of screws 42”, paragraph [0043]; screws 42, Fig. 9).
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.
Claims 3 and 5-8 are rejected under 35 U.S.C. 103 as being obvious over Johansson in view of Hortmann et al. (US 5411467 A) (hereon referred as Hortmann).
Regarding claims 3 and 5, Johansson teaches all the limitations of claim 1, but does not teach the energy being transferred from the replaceable outer ear unit to the fluid-filled tube-shaped device using electromagnetic stimulation.
However, Hortmann teaches a hearing device (“hearing aid for stimulation of the inner ear with a hydromechanical coupling element”, abstract) wherein energy is being transferred from the replaceable outer ear unit to the fluid-filled tube-shaped device using electromagnetic stimulation (“electromechanical converter can be integrated within a housing of an implantable signal processing device and can operate on the basis of…electromagnetic…principles”, Col. 2, lines 18-22) and inductive coupling (“inductive data transmission can be performed by coils 31 and 32”, Col. 3, lines 55-56).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the hearing device of Johansson with the electromagnetic stimulation and inductive coupling of Hortmann in order to receive acoustic energy and process the received signal of the hearing device.
Regarding claim 6, Johansson teaches all the limitations of claim 1, but does not teach the replaceable outer ear unit being configured to transfer energy to the fluid-filled tube-shaped device via a light-based transmission and piezoelectric translation.
However, Hortmann teaches the outer ear unit being configured to transfer energy to the fluid-filled tube-shaped device via a light-based transmission (“a light-dependent infrared link can also be provided for enabling a transcutaneous data transmission”, Col. 3, lines 61-63) and piezoelectric translation (“electromechanical converter…integrated within a housing of an implantable signal processing electronic device…can operate on the basis of…piezoelectric principles”, Col. 2, lines 18-22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the hearing device of Johansson with the light-based transmission and piezoelectric translation of Hortmann in order to transfer energy from the replaceable outer ear unit to the fluid-filled tube-shaped device.
Regarding claim 7, Johansson teaches all the limitations of claim 1, but does not teach the replaceable outer ear unit being configured to transfer energy to the fluid-filled tube-shaped device via aligned coils.
However, Hortmann teaches the outer ear unit being configured to transfer energy to the fluid-filled tube-shaped device via aligned coils (coils 31 and 32) such that a first coil in the outer ear unit (“external control signal transmitter 30…transmitting coil 31 is connected”, Col. 3, lines 51-54) is aligned with a second coil in the fluid-filled tube-shaped device (“receiving coil 32 is placed in housing 12”, Col. 3, lines 54-55, “sound-conducting tube 16 is connected to housing 12”, Col. 5, lines 2-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the hearing device of Johansson with the aligned coils of Hortmann in order to transfer energy to the fluid-filled tube-shaped device to allow the perception of sound in a patient (“the sound is fed to microphone 13 from tympanic cavity 17 by sound-conducting tube 16”, Col. 5, lines 1-2).
Regarding claim 8, Johansson teaches all the limitations of claim 1, but does not teach the fluid-filled tube-shaped device including an attached piezoelectric component.
However, Hortmann et al. teaches the fluid-filled tube-shaped device including an attached piezoelectric component ("the hydromechanical coupling element can simply be a fluid-filled tube that is connected to the electromechanical converter", Col. 2, lines 3-6, "electromechanical converter can be integrated within a housing of an implantable signal processing electronic device and can operate on the basis of electrodynamic, electromagnetic or, preferably, piezoelectric principles", Col. 2, lines 18-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the fluid-filled tube-shaped device of Gilman with the attached piezoelectric component of Hortmann et al., in order to provide a sufficiently small electrodynamic receiver for rapidly converting received acoustic signals from the outer ear unit.
Claim 4 is rejected under 35 U.S.C. 103 as being obvious over Johansson in view of Schumaier (US 7302071 B2).
Regarding claim 4, Johansson teaches all the limitations of claim 1, but does not teach energy being transferred from the replaceable outer ear unit to the fluid-filled tube-shaped device via a radiofrequency stimulation.
However, Schumaier teaches a hearing device (“bone conduction hearing aid”, abstract) wherein energy is being transferred from the replaceable outer ear unit to the fluid-filled tube-shaped device via a radiofrequency stimulation (“a transmitter transmits processed signals to ITE member 14 wirelessly, such as by radio frequency”, Col. 2, lines 49-51; in-the-ear (ITE) member 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the hearing device of Johansson with Schumaier to transfer energy from the replaceable outer ear unit to the fluid-filled tube-shaped device.
Claim 9 is rejected under 35 U.S.C. 103 as being obvious over Johansson in view of Abel et al. (US 20050163333 A1) (hereon referred as Abel).
Regarding claim 9, Johansson teaches all the limitations of claim 1, but does not teach the fluid-filled tube-shaped device including an attached photo-responsive device that includes a photo strictive material.
However, Abel teaches the fluid-filled tube-shaped device including an attached photo- responsive device that includes a photostrictive material ("the photoreceiver/actuator may be a single unit, or the photoreceiver and actuator may be separate and electrically connected by wiring. The photoreceiver may be a photo-sensitive diode, photo voltaic cell or other type of photoreceiver providing it can receive light generated from the light source", paragraph [0019]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the fluid-filled tube-shaped device of Johansson with the photo-responsive device of Abel in order to receive a light input and provide sufficient power to produce mechanical vibrations that induce neural impulses and create sounds.
Claims 18, 19, 24 and 25 are rejected under 35 U.S.C. 103 as being obvious over Johansson in view of Gilman (US 5176620 A).
Regarding claims 18, 19, and 25, Johansson teaches all the limitations of claim 1, but does not teach the fluid-filled tube-shaped device being configured to transmit hearing information with a rigid inner ear contact, a flexible inner ear contact, and the fluid-filled tube-shaped device being secured in place using silicone or metal.
However, Gilman teaches a hearing device (“hearing aid”, abstract) with a fluid-filled tube-shaped device being configured to transmit hearing information with a rigid inner ear contact, a flexible inner ear contact, and the fluid-filled tube-shaped device being secured in place using silicone or metal ("the tube 142 is held in place with a biologically compatible sealing material 92 such as Gelfoam sold by Upjohn, cartilage, perichondrium, mucosal seal, blood clot, fat and (for silicon tubing) tube may be surrounded by materials such as titanium or synthetic bone which are capable of being bonded by natural bone", Col. 5, lines 34-41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the fluid-filled tube-shaped device of Johansson with the device of Gilman and transmit hearing information via a rigid or flexible inner ear contact depending on the ear of the patient and implant the device in place using silicone or metal to ensure the it is securely placed.
Regarding claim 24, Johansson teaches all the limitations of claim 1, but does not teach the fluid-filled tube-shaped device being secured using heat-activated metal arms.
However, Gilman teaches the fluid-filled tube-shaped device being secured using heat-activated metal arms. An example of such heat activated arms can be composed of nickel titanium (“the tube 142 may be surrounded by materials such as titanium”, Col. 5, lines 39-40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the hearing device of Johansson with Gilman and utilize heat-activated metal arms to secure the fluid-filled tube-shaped device in order to ensure that the implant is securely attached to the middle ear structures.
Claim 22 is rejected under 35 U.S.C. 103 as being obvious over Johansson in view of Djalilian et al. (US 20150104053 A1) (hereon referred as Djalilian).
Regarding claim 22, Johansson teaches all the limitations of claim 1, but does not teach the fluid-filled tube-shaped device being secured using flanges.
However, Djalilian teaches a hearing device (“hearing device”, abstract) wherein the fluid-filled tube-shaped device is being secured using flanges (“insert can be placed such that flanges on the side and outside of the tympanic membrane hold insert”, paragraph [0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the hearing device of Johansson with Djalilian and utilize flanges as a way to secure the fluid-filled tube-shaped device in order to ensure that the implant is securely placed within the tympanic membrane and middle ear structures.
Response to Arguments
Applicant’s arguments, see page 6, filed 27 May 2026, with respect to the claim objections have been fully considered and are persuasive in light of the amendments. The claim objections have been withdrawn.
Applicant’s arguments with respect to claims 1-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The rejection of all pending claims 1-25 under 35 U.S.C. § 102(a)(1) and 35 U.S.C. § 103 have been updated accordingly.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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, Alexander Valvis can be reached at 5712724233. 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.
/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights