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 with traverse of Species Group I, directed to claims 1-11, 13-14, and 16-19 in the reply filed on 03/24/2026 is acknowledged. The traversal is on the ground(s) that the shared technical feature (an active implant and a percutaneous abutment) asserted in the previous office action, mailed on 01/29/2026, is not the shared special technical feature. Applicant states that the prior art does not address “at least one subcutaneous electrical contact and at least one supracutaneous electrical contact”. As discussed below, Andersson in view of Leigh discusses the use of electrical leads comprising conductive rings to achieve electrical connectivity within the apparatus.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12, 15, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/24/2026.
Specification
The use of the term "BLUETOOTH", which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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:
“sound input devices” recited in claim 6; equivalent structure found in para. 0022. Therefore, in light of the specification, “sound input devices” are best understood as microphones, auxiliary inputs, audio input ports, cable ports, telecoils, a wireless transceiver, accelerometers, and equivalents thereof.
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.
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 § 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 5 is 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 5 recites the limitation “the active implant overlaps both the percutaneous abutment and the active implant” in lines 1-2. It is unclear how the active implant is structurally configured to overlap itself. Consistent with the specification (Figure 1), it appears as though the active implant overlaps both the percutaneous abutment and the bone fixture; henceforth, for examination purposes, the claim will be read as such.
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, 7-8, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andersson et al. (US 9,107,013), hereinafter "Andersson et al. 013" in view of Leigh (US 2013/0041428).
Regarding claim 1, Andersson et al. 013 teaches an apparatus (Abstract) comprising:
a bone fixture configured to anchor to bone of a recipient (Fig. 7, bone fixture 702; Col. 14, lines 4-6);
a percutaneous abutment configured to mechanically couple to the bone fixture (Fig. 7, abutment 704; Col. 13, line 57; Col. 14, lines 26-29; see Annotated Figure 7); and
an active implant (Fig. 7, piezoelectric material 710A; Col. 14, lines 32-33, wherein the piezoelectric material deforms in response to electrical signals) configured to be anchored by at least one of the bone fixture (Col. 14, lines 30-34; see Fig. 7 wherein 710A is coupled to the bone fixture 702 which is anchored to the skull) or the percutaneous abutment at a location least partially between the bone fixture and the percutaneous abutment (see Fig. 7, the piezoelectric material 710A is located between the abutment 704 and bone fixture 702).
Andersson et al. 013 further teaches electrical leads extending from the skin-penetrating abutment through the active implant to the bone fixture (Col. 14, lines 59-61). Andersson et al. 013 does not explicitly state electrical contacts, nonetheless, the presence of electrical leads extending through the entire apparatus implies there are electrical contacts disposed therein to facilitate electrical connectivity and signal transmission.
Nevertheless, Leigh teaches an analogous apparatus wherein a lead comprises electrical contacts (Abstract; Fig. 10; paras. 0107 and 0109).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the electrical leads of Andersson et al. 013 with the lead comprising a conductive ring of Leigh. This modification would facilitate the electrically coupling of the extending leads, therein producing a crosslinked transmission signal pathway (Leigh, Abstract; paras. 0096 and 0107).
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Annotated Figure 7
Regarding claim 3, Andersson et al. 013, in view of Leigh, teaches the apparatus according to claim 1 as stated above wherein the active implant is coupled directly to the percutaneous abutment (Andersson et al. 013, as shown in Fig. 7, the piezoelectric material 710A is in direct contact with the abutment 404 and abutment fastener – see Annotated Figure 7 above; Col. 14, lines 26-36 and lines 59-61).
Regarding claim 5, as best understood in light of the rejections under 35 U.S.C. 112(b) above, Andersson et al. 013, in view of Leigh, teaches the apparatus according to claim 1 as stated above wherein the active implant overlaps both the percutaneous abutment and the bone fixture (Andersson et al. 013, Col. 14, lines 30-34; see Annotated Figure 7A).
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Annotated Figure 7A
Regarding claim 7, Andersson et al. 013, in view of Leigh, teaches the apparatus according to claim 1 as stated above further comprising an external device (Andersson et al. 013, Fig. 2, external device 240; Fig. 4, external device 440; Col. 7, lines 44-45; Col. 15, lines 10-19), wherein the external device includes at least one external electrical contact for electrical connection with at least one supracutaneous electrical contact (Leigh, Abstract; Fig. 10; paras. 0107 and 0109).
Regarding claim 8, Andersson et al. 013, in view of Leigh, teaches the apparatus according to claim 7 as stated above wherein the external device is configured to supply power and data to the active implant (Andersson et al. 013, Col. 14, lines 31-33 and Col. 15, lines 10-21; Fig. 2, external device 240, electrical signal 224, and power module 210; Fig. 4, external device 440) via the electrical connection between the at least one supracutaneous electrical contact and the at least one external electrical contact and the electrical connection between the at least one subcutaneous electrical contact and the at least one active implant electrical contact (Leigh, Abstract; Fig. 10; paras. 0107 and 0109).
Regarding claim 16, Andersson et al. 013 teaches an apparatus (Abstract) comprising:
a bone fixture configured to anchor to bone of a recipient (Fig. 7, bone fixture 702; Col. 14, lines 4-6);
a percutaneous abutment coupled to the bone fixture (Fig. 7, abutment 704; Col. 13, line 57; Col. 14, lines 26-29; see Annotated Figure 7); and
an active implant (Fig. 7, piezoelectric material 710A) disposed coaxially with the bone fixture and the percutaneous abutment (see Annotated Figure 7B; Col. 14, lines 26-34).
Andersson et al. 013 further teaches electrical leads extending from the skin-penetrating abutment through the active implant to the bone fixture (Col. 14, lines 59-61). Andersson et al. 013 does not explicitly state electrical contacts, nonetheless, the presence of electrical leads extending through the entire apparatus implies there are electrical contacts disposed therein to facilitate electrical connectivity and signal transmission.
Nevertheless, Leigh teaches an analogous apparatus wherein a lead comprises electrical contacts (Abstract; Fig. 10; paras. 0107 and 0109).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the electrical leads of Andersson et al. 013 with a lead comprising a conductive ring of Leigh. This modification would facilitate the electrically coupling of the extending leads, therein producing a crosslinked transmission signal pathway (Leigh, Abstract; paras. 0096 and 0107).
While the combination of Andersson et al. 013, in the embodiment relied upon above, and Leigh teaches a bone fixture, a percutaneous abutment, electrical contacts, and an active implant disposed coaxially with the bone fixture and the percutaneous abutment, the combination of Andersson et al. 013, in the embodiment relied upon above, and Leigh fails to disclose wherein the active implant comprises a vibratory actuator.
Andersson et al. 013, in a separate embodiment, teaches wherein the active implant comprises a vibratory actuator (Col. 7, lines 49-57; Fig. 4).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the apparatus disclosed in the first embodiment of Andersson et al. 013, in view of Leigh, with the active implant comprising a vibrating actuator disclosed in the second embodiment of Andersson et al. 013. This modification provides the apparatus with an implantable component (actuator) that converts electrical signals into mechanical motion to impart vibrations in the recipient’s skull (Andersson et al. 013, Col. 6, lines 55-60; Col. 7, lines 47-57).
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Claim(s) 2 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andersson et al. 013 in view of Leigh as applied to claim 1 above, further in view of Jinton et al. (US 2015/0146902).
Regarding claim 2, Andersson et al. 013, in view of Leigh, teaches the apparatus according to claim 1 as stated above. Andersson et al. 013 further teaches a fastener coupling the percutaneous abutment to the bone fixture (see Annotated Figure 7),
wherein the active implant, the percutaneous abutment, the fastener, and the bone fixture are coaxial (see Annotated Figure 7B; Col. 14, lines 26-34). Andersson, in view of Leigh, fails to teach a threaded fastener.
Jinton et al. teaches an analogous apparatus further comprising a threaded fastener (para. 0070; Fig. 2B, threaded portion 16 of the connection 12).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the fastener of Andersson et al. 013, in view of Leigh, with the threaded fastener of Jinton et al. Implementing a threaded fastener facilitates the mechanical engagement of an abutment screw with the mated bore of a bone fixture (Jinton et al., para. 0070).
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Regarding claim 10, Andersson et al. 013, in view of Leigh, teaches the apparatus according to claim 1 as stated above. Andersson et al. 013 further teaches wherein the percutaneous abutment comprises a percutaneous abutment fastener configured to mate with a bone fixture aperture to couple the percutaneous abutment to the bone fixture (Col. 14, lines 16-18; see Annotated Figure 7C). Andersson, in view of Leigh, fails to specifically teach a percutaneous abutment thread configured to mate with a bone fixture thread.
Jinton et al. teaches an analogous apparatus wherein the percutaneous abutment comprises a percutaneous abutment thread configured to mate with a bone fixture thread to couple the percutaneous abutment to the bone fixture (para. 0070; Fig. 2B).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the fastener and bone fixture aperture of Andersson et al. 013, in view of Leigh, with the abutment thread and bone fixture thread of Jinton et al. Implementing a threaded fastener facilitates the mechanical engagement of a centrally arranged abutment screw with the mated bore of a bone fixture (Jinton et al., para. 0070).
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Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andersson et al. 013 in view of Leigh, further in view of Meskens (US 2017/0318399).
Regarding claim 4, Andersson et al. 013, in the embodiment relied upon above, in view of Leigh, teaches the apparatus according to claim 1 as stated above. Andersson et al. 013, in the embodiment relied upon above, in view of Leigh, fails to teach wherein the active implant comprises an actuator and one or more processors.
Andersson et al. 013, in a separate embodiment, teaches wherein the active implant comprises a vibratory actuator (Col. 7, lines 49-57; Fig. 4).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the apparatus disclosed in the first embodiment of Andersson et al. 013, in view of Leigh, with the active implant comprising a vibrating actuator disclosed in the second embodiment of Andersson et al. 013. This modification provides the apparatus with an implantable component (actuator) that converts electrical signals into mechanical motion to impart vibrations in the recipient’s skull (Andersson et al. 013, Col. 6, lines 55-60; Col. 7, lines 47-57).
While Andersson et al. 013, in a separate embodiment relied upon above, in view of Leigh, teaches wherein the active implant comprises an actuator, the combination of Andersson et al. 013, in the separate embodiment relied upon above, and Leigh fails to disclose wherein the active implant comprises one or more processors.
Meskens teaches an analogous apparatus wherein the active implant comprises a one or more processors (para. 0006; Fig. 5, vibrating actuator 552; paras. 0050 and 0070-0072; Fig. 12, circuit 1291).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the apparatus of Andersson et al. 013, in view of Leigh, with the active implant comprising an actuator and one or more processors of Meskens. The addition of processors or circuity allows electrical currents to pass from the external components, i.e., external device into the implantable components, therein creating vibrations (Meskens, paras. 0070 and 0073).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andersson et al. 013 in view of Leigh, further in view of Khing et al. (US 2017/0180873).
Regarding claim 6, Andersson et al. 013, in view of Leigh, teaches the apparatus according to claim 1 as stated above. Andersson et al. 013, in view of Leigh, fails to teach wherein the percutaneous abutment comprises one or more sound input devices or one or more antennas.
Khing et al. teaches an analogous apparatus wherein the percutaneous abutment comprises one or more sound input devices or one or more antennas (para. 0013).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the apparatus of Andersson et al. 013, in view of Leigh, with the abutment comprising microphones of Khing et al. Modifying the abutment to include a microphone array may reasonably amplify sound from the front of the recipient and attenuate sound from behind the recipient (Khing et al., para. 0015).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andersson et al. 013 in view of Leigh, further in view of Bergs et al. (US 2015/0117689).
Regarding claim 9, Andersson et al. 013, in view of Leigh, teaches the apparatus according to claim 1 as stated above. Andersson et al. 013, in view of Leigh, fails to teach wherein the percutaneous abutment has a first section having a first degree of stiffness and a second section having a second degree of stiffness different from the first degree of stiffness.
Bergs et al. teaches an analogous apparatus wherein the percutaneous abutment has a first section having a first degree of stiffness and a second section having a second degree of stiffness different from the first degree of stiffness (para. 0083, “connection assembly is the coupling 441 snap coupled to the abutment 620”; para. 0087, “the coupling 441/541 is made out of plastic or a material that is otherwise relatively substantially less hard than the material of the abutment 620 (which in some embodiments is made out of titanium and/or other types of metals)”; see Annotated Figure 6 below).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the apparatus of Andersson et al. 013, in view of Leigh, with the abutment that has a first and second degree of stiffness of Bergs et al. Doing so creates a metallic, rigid abutment reinforced with a deformable, resealable, and exchangeable coupling mechanism, that when used together permits efficient transmission of vibrational energy (Bergs et al., paras. 0032, 0059, and 0087).
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Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andersson et al. 013 in view of Leigh, further in view of Della Santina et al. (US 2007/0208403).
Regarding claim 11, Andersson et al. 013 teaches a system (Abstract) comprising:
a percutaneous abutment (Fig. 7, abutment 704; Col. 13, lines 55-57);
an active implant (Fig. 7, piezoelectric material 710A; Col. 14, lines 30-34); and
an external device (Col. 15, lines 10-21).
Andersson et al. 013 further teaches electrical leads extending from the skin-penetrating abutment through the active implant to the bone fixture (Col. 14, lines 59-61). Andersson et al. 013 does not explicitly state electrical contacts, nonetheless, the presence of electrical leads extending through the entire apparatus implies there are electrical contacts disposed therein to facilitate electrical connectivity and signal transmission.
Nevertheless, Leigh teaches an analogous system wherein a lead comprises electrical contacts (Abstract; Fig. 10; paras. 0107 and 0109).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the electrical leads of Andersson et al. 013 with a lead comprising a conductive ring of Leigh. This modification would facilitate the electrically coupling of the extending leads, therein producing a crosslinked transmission signal pathway (Leigh, Abstract; paras. 0096 and 0107).
While Andersson et al. 013, in view of Leigh teaches the electrical contacts, percutaneous abutment, active implant, and external device, the combination of Andersson et al. 013 and Leigh fails to specifically disclose wherein an active implant comprises an implant power source and wherein the external device is configured to charge the implant power source via electrical coupling.
Della Santina et al. teaches an analogous system wherein an active implant comprises an implant power source (Fig. 1C, “PWR” within the implanted unit 132; para. 0040) and wherein the external device is configured to charge the implant power source (paras. 0045-0047; Fig. 1C).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the active implant and external device of Andersson et al. 013, in view of Leigh, with the active implant comprising an implant power source and the external device configured to charge the implant power source of Della Santina et al. Modifying the active implant with a power source may create a self-sufficient, fully implantable active component that would require only periodic recharging (Della Santina et al., paras. 0006 and 0074). Furthermore, modifying the external device to charge the implant power source (via the electrical coupling of Andersson et al. 013, in view of Leigh) creates a suitable control channel between the implantable component and external device, wherein appropriate commands and power signals may be sent and received (Della Santina et al., paras. 0004 and 0045-0047).
Regarding claim 13, Andersson et al. 013, in view of Leigh, further in view of Della Santina et al. teaches the system according to claim 11 as stated above wherein the external device is configured to supply power and data to the active implant (Andersson et al. 013, Col. 14, lines 31-33 and Col. 15, lines 10-21; Fig. 2, external device 240, electrical signal 224, and power module 210; Fig. 4, external device 440) via the electrical connection between the at least one supracutaneous electrical contact and the at least one external electrical contact and the electrical connection between the at least one subcutaneous electrical contact and the at least one active implant electrical contact (Leigh, Abstract; Fig. 10; paras. 0107 and 0109).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andersson et al. 013 in view of Leigh and Della Santina et al. as applied to claim 11 above, further in view of Asfaw et al. (US 2017/0353784).
Regarding claim 14, Andersson et al. 013, in view of Leigh, further in view of Della Santina et al. teaches the system according to claim 11 as stated above. Andersson et al. 013, in view of Leigh, further in view of Della Santina et al. fails to teach a vibration damper configured to resist transmission of vibrations between the active implant and the external device.
Asfaw et al. teaches an analogous system further comprising a vibration damper configured to resist transmission of vibrations between the active implant (para. 0003, bone duction transducer “BCT”) and the external device (Fig. 2A, wherein the external device may be a wearable device 200; paras. 0027, 0033, 0039, and 0102).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the system of Andersson et al. 013, in view of Leigh, further in view of Della Santina et al. with the vibration damper of Asfaw et al. Incorporating a vibration damper may reduce audio-related buzzing and irritation (Asfaw et al., para. 0006).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andersson et al. 013 in view of Leigh as applied to claim 16 above, further in view of Andersson et al. (US 2012/0302823), hereinafter “Andersson et al. 823”.
Regarding claim 17, Andersson et al. 013, in view of Leigh, teaches the apparatus according to claim 16 as stated above. Andersson et al. 013, in view of Leigh, further teaches:
the external device (Andersson et al. 013, Col. 15, lines 10-15), wherein the external device comprises a microphone, a power source, and a sound processor (Andersson et al. 013, Fig. 2, external device 240, power module 210, sound input element 226, sound processor 227);
wherein the external device is electrically coupled to the active implant via electrical couplings electrical couplings (Andersson et al. 013, Col. 14, lines 59-61) between the at least one supracutaneous electrical contact of the percutaneous abutment and the at least one external device electrical contact of the external device and between the at least one subcutaneous electrical contact of the percutaneous abutment and the at least one active implant electrical contact of the active implant (Leigh, Fig. 10; paras. 0107 and 0109); and
wherein the sound processor is configured to cause the vibratory actuator to actuate (Andersson et al. 013, Col. 5, lines 56-67 and Col. 6, lines 1-23).
Andersson et al. 013, in view of Leigh, fails to teach wherein the external device is mechanically coupled to the percutaneous abutment.
Andersson et al. 823 teaches an analogous apparatus wherein the external device is mechanically coupled to the percutaneous abutment (Fig. 7; para. 0091).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the apparatus of Andersson et al. 013, in view of Leigh, with the mechanically coupled external device of Andersson et al. 823. Doing so allows the external device to be removably coupled to the percutaneous abutment (Andersson et al., paras. 0091-0094).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andersson et al. 013 in view of Leigh as applied to claim 16 above, further in view of Andersson et al. 823, Della Santina et al., and Khing et al.
Regarding claim 18, Andersson et al. 013, in view of Leigh, teaches the apparatus according to claim 16 as stated above. Andersson et al. 013, in view of Leigh, further teaches:
the external device (Andersson et al. 013, Col. 15, lines 10-15), wherein the external device comprises an external device power source (Andersson et al. 013, Fig. 2, external device 240, power module 210);
wherein the external device is configured to electrically couple to the active implant via electrical couplings electrical couplings (Andersson et al. 013, Col. 14, lines 59-61) between the at least one supracutaneous electrical contact of the percutaneous abutment and the at least one external device electrical contact of the external device and between the at least one subcutaneous electrical contact of the percutaneous abutment and the at least one active implant electrical contact of the active implant (Leigh, Fig. 10; paras. 0107 and 0109).
Andersson et al. 013, in view of Leigh, fails to teach wherein the external device is configured to mechanically couple to the percutaneous abutment; wherein the external device is configured to charge an implanted power source of the active implant from the external device power sources; and wherein the percutaneous abutment comprises a supracutaneous microphone configured to supply data to the active implant.
Andersson et al. 823 teaches an analogous apparatus wherein the external device is mechanically coupled to the percutaneous abutment (Fig. 7; para. 0091).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the apparatus of Andersson et al. 013, in view of Leigh, with the mechanically coupled external device of Andersson et al. 823. Doing so allows the external device to be removably coupled to the percutaneous abutment (paras. 0091-0094)
While Andersson et al. 013, in view of Leigh, further in view of Andersson et al. 823 teaches the external device which is configured to mechanically and electrically couple to the percutaneous abutment and active implant, respectively, the combination of Andersson et al. 013, Leigh, and Andersson et al. 823 fails to teach an implanted power source of the active implant and wherein the percutaneous abutment comprises a supracutaneous microphone configured to supply data to the active implant.
Della Santina et al. teaches an analogous apparatus wherein the external device is configured to charge an implanted power source of the active implant from the external device power source (Fig. 1C, “PWR” within the implanted unit 132; para. 0040; paras. 0045-0047; Fig. 1C).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the active implant and external device of Andersson et al. 013, in view of Leigh, further in view of Andersson et al. 823, with the active implant comprising an implant power source and the external device configured to charge the implant power source of Della Santina et al. Modifying the active implant with a power source may create a self-sufficient, fully implantable active component that would require only periodic recharging (Della Santina et al., paras. 0006 and 0074). Furthermore, modifying the external device to charge the implant power source (via the electrical coupling of Andersson et al. 013, in view of Leigh) creates a suitable control channel between the implantable component and external device, wherein appropriate commands and power signals may be sent and received (Della Santina et al., paras. 0004 and 0045-0047).
While Andersson et al. 013, in view of Leigh, further in view of Andersson et al. 823 and Della Santina et al. teaches the external device configured to mechanically and electrically couple to the percutaneous abutment and active implant, respectively, and the active implant’s implanted power source, the combination of Andersson et al. 013, Leigh, Andersson et al. 823, and Della Santina et al. fails to teach wherein the percutaneous abutment comprises a supracutaneous microphone configured to supply data to the active implant.
Khing et al. teaches an analogous apparatus wherein the percutaneous abutment comprises a supracutaneous microphone configured to supply data (paras. 0009 and 0013, and 0044).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the apparatus of Andersson et al. 013, in view of Leigh, further in view of Andersson et al. 823 and Della Santina et al. with the abutment comprising microphones of Khing et al. Modifying the abutment to include a microphone array may satisfactorily amplify sound from the front of the recipient and attenuate sound from behind the recipient (Khing et al., para. 0015). Additionally, because the microphones are able to generate audio signals and send those signals to a sound processor (Khing et al., para. 0044), one of ordinary skill in the art could infer that the microphones are electrically configured to supply data to different components possessing processing hardware.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andersson et al. 013 in view of Leigh as applied to claim 16 above, further in view of Asfaw et al.
Regarding claim 19, Andersson et al. 013, in view of Leigh, teaches the apparatus according to claim 16 as stated above. Andersson et al. 013, in view of Leigh, fails to teach a vibration damper configured to resist transmission of vibrations from the active implant along the percutaneous abutment.
Asfaw et al. teaches an analogous apparatus further comprising a vibration damper configured to resist transmission of vibrations between the active implant (para. 0003, bone duction transducer “BCT”) along the percutaneous abutment (para. 0027; para. 0033, wherein the BCT may be a bone-anchored hearing aid which would include an abutment-like component; paras. 0039, and 0102).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined the apparatus of Andersson et al. 013, in view of Leigh, with the vibration damper of Asfaw et al. Incorporating a vibration damper may reduce audio-related buzzing and irritation (Asfaw et al., para. 0006).
Conclusion
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/BROGAN R LANDEEN/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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