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 .
Claim Objections
Claim 25 is objected to because of the following informalities:
Regarding claim 25, “device” should be between “fluid-filled tube-shaped” and “is secured”.
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.
Claims 1-3, 5, 10-21, 24, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gilman (US 5176620 A).
Regarding claim 1, Gilman teaches a semi-implantable hearing device (hearing aid 100, Fig. 1) comprising:
A replaceable outer ear unit (microphone 122, shown in annotated Fig. 1 below) having an energy transfer device for generating energy responsive to acoustic energy received by the replaceable outer ear unit (“electromechanical means 120 housed in the enclosure 110 converts acoustical energy received by microphone means 112 from the outer environment 64 via skin flap 88 into mechanical motion which is transmitted by the liquid filled tube 142”, Col. 3, lines 48-52; shown in annotated Fig. 1 below), the replaceable outer ear unit being adapted to be located inside a subject’s outer ear canal or behind a subject’s ear (“an alternate position for the microphone adjacent the auditory canal may also be used”, Col. 3, lines 52-54; shown in annotated Fig. 1 below); and
A fluid-filled tube-shaped device (liquid filled tube 142, shown in annotated Fig. 1 below) that is placed in the middle ear or mastoid (“a liquid transmission means 140 in the form of a liquid filled tube 142 is also implanted in the mastoid bone 62”, Col. 3, lines 41-43), the fluid-filled tube-shaped device adapted to receive transferred energy from the replaceable outer ear unit 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 (“a part of this invention is the selection of liquids which are compatible with the liquid (perilymph) in the scala tympani of the human cochlea (inner ear). Such selection can include liquids whose acoustic characteristics are such as to maximize the conduction of sound into the cochlea”, Col. 4, lines 9-14).
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Regarding claim 2, Gilman teaches the fluid-filled tube-shaped device (liquid filled tube 142, Fig. 1) including the fluid enclosed by a closed flexible tube (“proximal end 144 of the liquid filled tube 142 connects through a coupler 112 to the enclosure 110”, Col. 3, lines 44-45, “membrane 148 closes the distal end 146 of the tube 142”, Col. 5, lines 29-30, “tube 142 may be of a biologically inert material such as silicone elastomer”, Col. 5, lines 21-23).
Regarding claims 3 and 5, Gilman teaches the energy being transferred from the replaceable outer ear unit to the fluid-filled tube-shaped device using electromagnetic stimulation and inductive coupling. (“the transducer means 124 may be any of those well known in the art including the constant displacement type where the displacement is proportional to the applied voltage. Examples are piezo-electric, magnetostrictive and capacitive transducers. The microphone means 122, induction coil means 128, and the battery power means 126 may be any of those well known in the art”, Col. 6, lines 47-54).
Regarding claim 10, Gilman teaches the fluid-filled tube-shaped device being secured by attaching the fluid filled tube to the ossicular chain in the subject’s ear (liquid-filled tube device 142 attached to ossicular chain 40 shown in annotated Fig. 1 below).
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Regarding claim 11, Gilman teaches the replaceable outer ear unit being hermetically sealed and implanted in a subject’s body (“hearing aid as defined in claim 32 wherein said sealing means comprises a biologically compatible sealing material arranged to seal said intersection”, claim 34).
Regarding claim 12, Gilman teaches the fluid-filled tube-shaped device being configured to make inner ear contact by contacting the round window membrane (“proximal end 144 of the liquid filled tube 142 connects through a coupler 112 to the enclosure 110 while the distal end 146 is inserted through the middle ear cavity 38 to the round window 52 of the cochlea 46”, Col. 3, lines 44-47; round window 52, Fig. 2).
Regarding claim 13, Gilman teaches the fluid-filled tube-shaped device being configured to make inner ear contact by contacting the oval window or one or more ossicle (“the distal end 146 may be surgically inserted through the stapes 44 and oval window 60 to the position 146f”, Col. 5, lines 16-18).
Regarding claims 14, Gilman 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 (“Figs. 3Q, R, S, T, and U illustrate termination of the liquid filled tube 142, 142’ with the perilymph 82 through an aperture 77 in the vestibule or promontory 78. The aperture is opened in the cochlea by surgical fenestration”, Col. 6, lines 5-9).
Regarding claims 15, Gilman teaches the fluid-filled tube-shaped device being configured to make outer contact with the tympanic membrane (“Figs. 3A, B, C, D, and E shows various terminations of the liquid filled tube 142, 142’ with the round window 52 and the perilymph 82 of the scala tympani 72…membrane 148 closes the distal end 146 of the tube 142 which is filled with a liquid 150”, Col. 5, lines 24-31).
Regarding claim 16, Gilman teaches the fluid-filled tube-shaped device being configured to make outer contact under skin of the subject’s ear canal (liquid filled tube 142 making outer contact under skin of ear canal 34 shown in Fig. 1).
Regarding claim 17, Gilman teaches the fluid-filled tube-shaped device being configured to make outer contact under skin behind or above the ear (liquid filled tube 142 making outer contact under skin behind and above the ear shown in Fig. 1).
Regarding claims 18, 19 and 25, Gilman teaches the fluid-filled tube-shaped device being configured to transmit hearing information with a rigid inner ear contact and a flexible inner ear contact, and is 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).
Regarding claims 20 and 21, Gilman teaches the fluid-filled tube-shaped device is being used for transmitting hearing information where the fluid-filled tube-shaped device can be placed through and traverses the tympanic membrane (“Figs. 3A, B, C, D and E show various terminations of the liquid filled tube 142, 142’ with the round window 52 and the perilymph 82 of the scala tympani 72…membrane 148 closes the distal end 146 of the tube 142 which is filled with a liquid 150”, Col. 5, lines 24-31).
Regarding claim 24, Gilman teaches the fluid-filled tube-shaped device being used for transmitting hearing information where the fluid-filled tube-shaped device is 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).
Claims 1, 4, 6, 7, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Djalilian et al. (US 20150104053 A1).
Regarding claim 1, Djalilian et al. teaches a semi-implantable hearing device (hearing aid device 109, Fig. 3) comprising:
A replaceable outer ear unit (“microphone 112 is located at the end of hearing aid 109”, paragraph [0043]; microphone 112, shown in annotated Fig. 3 and Fig. 9 below) having an energy transfer device for generating energy (“circuit 110 processes the received sound signal”, paragraph [0043]; circuit 110, shown in annotated Fig. 3 below) responsive to acoustic energy received by the replaceable outer ear unit, the replaceable outer ear unit being adapted to be located inside a subject’s outer ear canal (“wearable hearing device 108 may be placed deep in the ear canal so that it cannot be seen…might be acceptable that wearable hearing device 108 is visible…can extend out of ear canal 100”, paragraph [0035]); and
A fluid-filled tube-shaped device (“a fluid filled pouch can be used that interfaces with the tympanic membrane”, paragraph [0055]; shown in annotated Fig. 9 below) that is placed in the middle ear or mastoid (“hearing aid device configured to interface with the tympanic membrane using fluid”, paragraph [0054]) the fluid-filled tube-shaped device adapted to receive transferred energy from the replaceable outer ear unit 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 (“when pressure in produced in fluid 158 by the actuator of hearing aid device 156, the pressure will displace the tympanic membrane and will be perceived as sound by the user”, paragraph [0054], Fig. 9).
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Regarding claim 4, Djalilian et al. teaches energy being transferred from the replaceable outer ear unit to the fluid-filled tube-shaped device via a radiofrequency stimulation (“sounds can also be transmitted by radio, either wired or wirelessly while still maintaining noise cancelling abilities through filtering and occlusion of the ear canal”, paragraph [0086]).
Regarding claim 6, Djalilian et al. teaches the replaceable outer ear unit being configured to transfer energy to the fluid-filled tube-shaped device via a light-based transmission (“energy 144 can be light and device 142 will have a solar cell to convert the light to energy”, paragraph [0050]) and piezoelectric translation (“non-floating actuators include, but are not limited to, piezoelectric actuators”, paragraph [0062]).
Regarding claim 7, Djalilian et al. teaches the replaceable outer ear unit being configured to transfer energy to the fluid-filled tube-shaped device via aligned coils such that a first coil in the replaceable outer ear unit is aligned with a second coil in the fluid-filled tube-shaped device (“ear worn unit 140 is placed in an ear and energy 144 is transferred to hearing aid device 142…energy 144 can be electromagnetic energy that can be picked up by an inductive coil in device 142”, paragraph [0050], “energy may be transferred by electronic, electromagnetic…magnetic”, paragraph [0050]; shown in annotated Fig. 6 below).
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Regarding claim 22, Djalilian et al. teaches the fluid-filled tube-shaped device being used for transmitting hearing information where the fluid-filled tube-shaped device is secured using flanges (“insert 326 is fixed to the tympanic membrane…insert can be placed such that flanges on the inside and outside of the tympanic membrane hold insert 326 onto the tympanic membrane”, paragraph [0081]; Fig. 21A and 21B).
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gilman in view of Hortmann et al. (US 5411467 A).
Regarding claim 8, Gilman teaches all the limitations of claim 1, but does not teach the fluid-filled tube-shaped device including a 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 modify 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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gilman in view of Abel et al. (US 20050163333 A1).
Regarding claim 9, Gilman teaches all the limitations of claim 1, but does not teach an attached photo-responsive device that includes a photostrictive material.
However, Abel et al. 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 modify the fluid-filled tube-shaped device of Gilman with the photo-responsive device of Abel et al. in order to receive a light input and provide sufficient power to produce mechanical vibrations that induce neural impulses and create sounds.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Gilman in view of Johansson (US 20130245363 A1).
Regarding claim 23, Gilman teaches all the limitations of claim 1, but does not teach the fluid-filled tube-shaped device being secured using screw(s).
However, Johansson teaches the fluid-filled tube-shaped device being used for transmitting hearing information where the fluid-filled tube-shaped device is secured using screw(s) (“Fig. 9 discloses how the tube 20 is seated in a holder plate 34. A hole 44 is provided centrally in the plate 34, and the tube 20 pass through the hole 44. The plate 34 may be fastened in the bone tissue2 by means of screws 42 as seen in the left hand side of Fig. 9”, paragraph [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid-filled tube-shaped device of Gilman with the securing means including screws of Johansson, in order to provide removable securing means to the fluid-filled tube-shaped device.
Conclusion
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.
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/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791