DETAILED ACTION
Response to Amendment
This Office Action is responsive to the Amendment filed 10 December 2025. Claims 1-15 are now pending. The Examiner acknowledges the amendments to claims 1, 2, 9, 11, 12, 15.
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 1, 13 is objected to because of the following informalities:
-Claim 1 recites “an hollow housing” in line 3. Examiner recommends amending to –a hollow housing—
-Claim 13 recites “the liquid” in line 2. Examiner recommends amending to –the liquid material—
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11, and 12-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
-Claim 1 recites “filling and/or to be filled” in line 13. It is unclear if the liquid or gel material is required based off this limitation since it is recited as both “filling” the interior and “to be filled into an interior.” Further clarification should be provided to identify the requirement for filling the housing.
-Claim 2 recites “minimal air space or bubbles” in line 2. It is unclear what encompasses the limitation of minimal air space or bubbles. Further clarification should be provided to define this limitation.
-Claim 11 recites “the liquid material or gel material” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
-Claim 12 recites “the actuator” in line 6. There is insufficient antecedent basis for this limitation in the claim.
-Claim 13 recites “the liquid or gel material in the housing” in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-3, 5-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spitaels (U.S. 8184840) in view of Abel (U.S. 20120197066) and in further view of Neukermans (U.S. 6068589).
Regarding Claim 1, Spitaels teaches a coupler device for transmitting vibration energy to a round window membrane of a cochlea in a mammalian ear, [Col 4, lines 21-29]—reference to a combined set (interpreted to be a coupler device) that transfers energy to and from the inner ear. Comprising an hollow housing formed of an acoustically rigid and biocompatible material and having a first end and a second end, [Fig. 2A, element 6] and [Col 7, lines 55-56; “FIG. 8 shows another embodiment of the combined set according to the present invention and provided with an acoustically coupled sensing and/or stimulating member 23.”] and [Col 9, lines 34-44], wherein the hollow housing is dimensioned and configured to fit into a mammalian middle ear [Col 5, lines 5-12], a plate designed to fit sealingly into a first opening into the hollow housing at the first end and arranged for contact with an actuator that transmits vibration energy; [Col 5, lines 42-45] and [Fig. 2A, elements 9 (piston), 10 (actuator)], a flexible membrane sealed to a second opening into the hollow housing at the second end and arranged to transmit vibrations to the round window membrane when the coupler device is implanted; [Fig. 5G, elements 14 (flexible membrane), and 32 (middle ear).] and [Col 4, lines 21-29]. In this interpretation, it is understood by the statement referenced in Col 4, that when a flexible membrane is included in the embodiment, energy will be transferred by means of the flexible membrane to the round window (also referred to as the middle ear in the referenced patent). Spitaels is silent on and wherein the second end is configured to surround and seal against a bony rim perimeter of the round window membrane in the mammalian ear; and a liquid material or a gel material filling and/or to be filled into an interior of the hollow housing between the flexible membrane and the plate. Abel teaches and wherein the second end is configured to surround and seal against a bony rim perimeter of the round window membrane in the mammalian ear [0149-0150]—reference to the second wider cylindrical second forming a seal around the round window membrane. This interpretation of surrounding and sealing of a structure includes the understanding that another structure being placed around the disclosed anatomical area and that the anatomical area included in the limitation is generally recited. The bony rim perimeter may be referring generally to a perimeter of the round window membrane that involves bone or it could be referring to a specific structure such as the round window niche.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a sealing structure around the round window membrane as taught by Abel to fit within the anatomy of the ear as suggested by Spitaels as Spitaels discusses creating optimal volume displacement through diameter and sizing of the implant [Col 5, lines 5-12] with Abel because Abel teaches further injecting filler materials to surround the tubular members of the structure to securely hold this element in place [0151].
Spitaels and Abel are silent on and a liquid material or a gel material filling and/or to be filled into an interior of the hollow housing between the flexible membrane and the plate. Neukermans and a liquid material or a gel material filling and/or to be filled into an interior of the hollow housing between the flexible membrane and the plate [Fig. 2, elements 52 (liquid), 54 (flexible membrane), and 42/44 (fluid tilled tube that displaces diaphragm).].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a liquid or gel or filler material within the housing as taught by Neukermans to allow for coupling and securing the implant within the anatomy as suggested by Spitaels and Abel, as Spitaels discusses including a liquid filled tube coupling a remote element and vibration actuator [Col 7-8, lines 64-4] and Abel which discloses using a filler material to secure the tubular member in place [0151] with Neukermans because Neukermans teaches the amplification advantages of using a liquid within the hearing aid design [Col 8, lines 34-39].
Regarding Claim 2, Spitaels and Abel are silent on wherein the liquid material or gel material fills the interior of the hollow housing with minimal air space or bubbles.
Neukermans teaches wherein the liquid material or gel material fills the interior of the hollow housing with minimal air space or bubbles [Col 7, lines 58-60; “The liquid 52 must be degassed and free of bubbles so volumetric displacements of the diaphragm 46 are faithfully transmitted to the diaphragm 44.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to degas the liquid or gel or filler material within the housing as taught by Neukermans to prevent leakage and infiltration of the fluids and air in the surrounding areas of implantation as suggested by Spitaels and Abel, as Spitaels discusses inner ear fluid leaking along out walls of the piston in previous inventions [Col 1, lines 36-37] and Abel which discloses using a filler material to secure the tubular member in place [0151] with Neukermans because Neukermans teaches using laser welding to produce a seal without bubbles [Col 7, lines 62-65].
Regarding Claim 3, Spitaels further teaches wherein the device further comprises a soft rubbery material fixed to a perimeter of the second opening into the hollow housing at the second end and arranged to contact and seal against surfaces of bone surrounding the round window membrane [Col 6, lines 59-61; “This membrane 14 is preferably made of titanium, an elastomer like silicone, or another bio-compatible material.”] In this embodiment, the elastomer is interpreted as a soft rubbery material.
Regarding Claim 4, Spitaels and Abel are silent on wherein the hollow housing is filled with the liquid material. Neukermans teaches wherein the hollow housing is filled with the liquid material [Fig. 2, elements 52 (liquid).]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a liquid filler material within the housing as taught by Neukermans to allow for coupling and securing the implant within the anatomy as suggested by Spitaels and Abel, as Spitaels discusses including a liquid filled tube coupling a remote element and vibration actuator [Col 7-8, lines 64-4] and Abel which discloses using a filler material to secure the tubular member in place [0151] with Neukermans because Neukermans teaches the amplification advantages of using a liquid within the hearing aid design [Col 8, lines 34-39].
Regarding Claim 6, Spitaels further teaches wherein the first opening into the hollow housing is a window opening in a wall of the hollow housing, and wherein the window opening is positioned and arranged such that an axis perpendicular to the window opening is at an angle to a central axis of the hollow housing. See annotated Fig. 6 below.
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Regarding Claim 7, Spitaels further teaches wherein the axis perpendicular to the window opening is arranged to be perpendicular to the central axis of the hollow housing. See annotated Fig. 2A below.
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Regarding Claim 8, Spitaels further teaches wherein the hollow housing is tubular [Col 5, lines 38-40; “The segments of the implantable combined set are preferably cylindrically or oval shaped to optimally accommodate the necessary volume in the middle ear.”]
Regarding Claim 9, Spitaels and Abel are silent on wherein a cross-section of the hollow housing is a regular geometric shape. Neukermans teaches wherein a cross-section of the hollow housing is a regular geometric shape [Fig. 2]. In this interpretation the cross sections of the housing are shown to be a rectangular shape.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design the cross section of the housing as a regular geometric shape as taught by Neukermans to allow for adequate energy transfer as suggested by Spitaels and Abel, as Spitaels discusses forming a symmetric cross-section to minimize mass and inertia [Col 5, lines 53-61] and Abel which discloses transferring vibrational energy to the round window membrane [0048] with Neukermans because Neukermans teaches allowing the large force produced by the transducer to transform into larger displacement of the diaphragm.
Regarding Claim 10, Spitaels further teaches wherein the hollow housing has a configuration of a bent tubular structure [Fig. 9, see both elements 26 and 9] and [Col 5, lines 38-40; “The segments of the implantable combined set are preferably cylindrically or oval shaped to optimally accommodate the necessary volume in the middle ear.”] In this interpretation a bent tubular structure is represented in the housing configuration where the housing is shown to be bent at an angle relative to the bone. The element 26, which is a tube, is also shown to be of a bent tubular structure.
Regarding Claim 11, Spitaels further teaches wherein the flexible membrane is configured to balloon out toward and conform to a surrounding area of the round window membrane and round window niche to efficiently couple volume velocity of the liquid material or gel material in the hollow housing to the round window membrane [Col 7, lines 29-34; “Alternatively, as illustrated in FIG. 5G, the membrane 14 is expandable after introduction into an inner ear. The expanded membrane provides a larger functional surface facing the inner ear part where the implantable device is applied. This expanding allows for an increased volume displacement of the inner ear fluid.”] In this interpretation, the described structure would be capable of coupling volume velocity of fluid or gel material in the housing to the RWM and makes a statement towards volume displacement of inner ear fluid.
Regarding Claim 12, Spitaels teaches a method of coupling an actuator force to a round window of the cochlea, the method comprising obtaining a coupler device of claim 1; [Col 4, lines 21-29] and [Col 5, lines 42-45; “vibration actuator 10, is lodged inside the second segment of the frame. The actuator acts on the member 9 in order to transfer the generated vibration energy to the member, which on will transfer it to the inner ear fluid.”] and [Fig. 2A, elements 8 (second segment), 10 (actuator)], contacting the actuator to the plate element at the first end of the rigid hollow housing; [Col 5, lines 24-45] and [Fig. 2A, elements 8 (second segment), 10 (actuator)], implanting the coupler device into the middle ear cavity so that the second end of the rigid hollow housing is adjacent to bone surrounding the round window niche such that the flexible membrane can contact the filler material; [Col 7, lines 29-34] and [Fig. 5G]. In this embodiment, the filler material is considered the inner ear fluid. And mechanically fixing the coupler device within the middle ear cavity to prevent movement of the hollow housing of the coupler device within the middle ear cavity [Col 4, lines 52-57; “Moreover, as the slidably movable member is mounted inside the frame, there is no direct contact between the slidably movable member and the bone, thereby avoiding that the movement of the member would cause any bone wear or that a tissue or bone growth could come to hinder the movement of the member.”]
Spitaels and Abel are silent on inserting a filler material against the round window membrane to fill a round window niche. Neukermans teaches inserting a filler material against the round window membrane to fill a round window niche; [Fig. 2, elements 52 (liquid), 54 (flexible membrane), and 42/44 (fluid tilled tube that displaces diaphragm).].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a filler material to secure the coupling apparatus to the round window niche as taught by Neukermans to transfer energy to the inner ear as suggested by Spitaels, as Spitaels connecting between the apparatus and the round window niche to transfer energy towards and away from the ear [Col 4, lines 21-29] with Neukermans because Neukermans discloses the amplification advantages of using a liquid within the hearing aid design [Col 8, lines 34-39].
Regarding Claim 13, Spitaels and Abel are silent on further comprising transmitting vibrations with the actuator to cause the liquid or gel material within the hollow housing to transmit the vibrations to the round window membrane.
Neukermans teaches further comprising transmitting vibrations with the actuator to cause the liquid or gel material within the hollow housing to transmit the vibrations to the round window membrane [Col 8, lines 32-39; “The arrangement of the diaphragms 44 and 46 depicted FIG. 2 provides a mechanical impedance match for the transducer 54 The displacement amplification provided by the liquid 52 acts as the impedance transformer, and does so all the way into the audio range frequency. Consequently, the microactuator 32 depicted in FIG. 1 matches the characteristics of the transducer 54 to the characteristics desired for the hearing aid 10.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a liquid filler material within the housing as taught by Neukermans to transmit vibrations as suggested by Spitaels and Abel, as Spitaels discusses transferring energy to and from the inner ear [Col 4, lines 25-29] and Abel which discloses amplifying vibrational stimulus to the inner ear [0009] with Neukermans because Neukermans teaches generating vibrational energy across the perilymph fluid of the inner ear by means of the microactuator [Col 7, lines 10-13].
Regarding Claim 14, Spitaels further teaches further comprising sealing a soft rubbery material fixed to a perimeter of the second opening into the hollow housing at the second end against surfaces of bone surrounding the round window membrane [Col 6, lines 59-61]. In this embodiment, the elastomer is interpreted as a soft rubbery material.
Regarding Claim 15, Spitaels and Abel are silent on wherein the hollow housing is filled with the liquid material or the gel material within the interior of the hollow housing between the plate and the flexible membrane before the coupler device is implanted.
Neukermans further teaches wherein the hollow housing is filled with the liquid material or the gel material within the interior of the hollow housing between the plate and the flexible membrane before the coupler device is implanted [Col 4, lines 4-6 and 12-13; “The present invention includes in a second aspect a fully implantable hearing aid system having an improved microactuator.” And “An incompressible liquid fills the hermetically sealed body.”] and [Fig. 2] and [Col 4, lines 49-53].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a liquid filler material within the housing between the plate and the flexible membrane as taught by Neukermans to transmit vibrations as suggested by Spitaels and Abel, as Spitaels discusses use of membranes to displace volumes to deform the structure [Col 3, lines 45-57] and Abel which discloses displacement of alternative structures [0115] with Neukermans because Neukermans teaches displacement of the second diaphragm coupled by the liquid within the body to the first flexible diaphragm through application of electric signal [Col 4, lines 56-60].
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spitaels (U.S. 8184840) in view of Abel (U.S. 20120197066) and in further view of Neukermans (U.S. 6068589) and in even further view of Gilman (U.S. 5318502).
Regarding Claim 5, Spitaels, Abel and Neukermans are silent on wherein the hollow housing is filled with the gel material.
Gilman teaches wherein the hollow housing is filled with the gel material [Col 2, lines 59-61; “The present invention is directed to a gel or paste transmission means for transmitting acoustical energy to the cochlea.”] In this embodiment, the tube is interpreted as the hollow housing.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a gel filler material within the housing as taught by Gilman to transmit acoustic and vibrational energy as suggested by Spitaels Abel, and Neukermans, as Spitaels discusses transfer high frequency acoustical signals [Col 8, lines 37-42] and Abel which discloses effectively conducting vibrational energy across the middle ear cavity [0008] and Neukermans which discusses matching acoustic impedance to that of tissues of the body [Col 12, lines 1-4] with Gilman because Gilman teach using gel to closely match the acoustic impedance of the transmission line to that of the cochlea [Cols 2-3, lines 64-2].
Response to Arguments
Applicant's arguments filed 10 December 2025 with respect to the drawing and specification objections have been fully considered and are persuasive in light of the
amendments.
Applicant's arguments filed 10 December 2025 with respect to the claim objections have been fully considered and are persuasive in light of the amendments.
Applicant's arguments filed 10 December 2025 with respect to 35 U.S.C. 112(b)
rejections have been fully considered however; new rejections are presented for claims 1-15. Applicant presents an argument for claim 1 in regards to the requirement of the liquid material or gel material. The examiner maintains the rejection due to the language including “and/or” and “to be filled.” “To be filled” implies that the material is not necessarily required because it is stated in a passive voice construction. Therefore the rejection is maintained. Applicant also presents an argument in reference to claim 2 “minimal air space or bubbles.” The examiner maintains that it is not clear to one of ordinary skill in the art what “minimal” constitutes in terms of air space or bubbles. This is especially true given that the specification does not provide further details on whether this includes no air space/bubbles, a specified amount of air space/bubbles, or a separate embodiment. Therefore, the rejection is maintained.
Applicant’s arguments filed 10 December 2025 with respect to the rejection of
claims 1-15 under 35 U.S.C.103 have been fully considered and are persuasive,
however, new rejections are presented above in light of the amendments for claims 1-15. In regards to the rejection of claim 1 under 35 U.S.C. 103, applicant argues that Spitaels fails to disclose a liquid material or gel material filling and/or to be filled into the interior of the hollow housing as well as “the second end is configured to surround and seal against a bony rim perimeter of the round window membrane in the mammalian ear.” The examiner maintains that Spitaels teaches a coupler device that is referred to as a combination set coupled with a sensing and/or stimulating member as referenced in the rejection. In regards to the added limitation, a new grounds of rejection is presented in light of the amendment including “surround and seal against.” An interpretation of the prior art used to rejection this claim is included in the body of the rejection.
In regards to claim 5, applicant argues that no combination of Spitaels, Neukermans and Gilman teaches every feature of claim 1. New grounds of rejection are presented in light of the amendments.
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 BROOKE NICOLE KOHUTKA whose telephone number is (571)272-5583. The examiner can normally be reached Monday-Friday 7:30am-5:00pm EST.
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791