DETAILED ACTION
Election/Restrictions
Newly submitted claim 21 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 21.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 21 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
This Office Action is in response to the amendment filed 07/20/2026. Claims 1-19 and 21 are acknowledged as pending with claims 1, 5, 7, 11, and 16 being currently amended, claim 21 being new, and claim 20 being cancelled. Claims 12 and 15 remain withdrawn from consideration. In similar fashion, because claim 21 is drawn to a nonelected species, it is withdrawn from consideration.
The specification objection, the rejection under 35 U.S.C. 112(b), and the rejections under 35 U.S.C. 103 are withdrawn as having been overcome by the amendment. New rejections necessitated by the amendment are presented below.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 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.
Claim Objections
Claims 11 and 18 are objected to because of the following informalities:
In claim 11, lines 7-8, “memory, a processor” should read “memory, and a processor”
In claim 18, line 7, “subcutaneous” should read “supracutaneous”
In claim 18, line 9, “supracutaneous” should read “subcutaneous”
Appropriate correction is required.
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 Mann et al. (WO 2011046586), hereinafter "Mann et al. 586", further in view of Mann et al. (US 8,554,329), hereinafter "Mann et al. 329".
Regarding claim 1, Andersson et al. 013 teaches an apparatus (Abstract) comprising:
a bone fixture (Fig. 7, bone fixture 702; Col. 14, lines 4-6);
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 to bone of a recipient via 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); and
a percutaneous abutment (Fig. 7, abutment 704; Col. 14, lines 26-28).
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 fails to specifically teach wherein the active implant comprises at least one active implant electrical contact; and a percutaneous abutment comprising at least one supracutaneous electrical contact and at least one subcutaneous electrical contact, wherein the percutaneous abutment is configured to be coupled to the active implant to align and place the at least one subcutaneous electrical contact against the at least one active implant electrical contact to establish an electrical connection, and the percutaneous abutment is configured to be decoupled from the active implant to separate the at least one subcutaneous electrical contact from the at least one active implant electrical contact.
In the same field of endeavor, Mann et al. 586 teaches wherein the active implant (Fig. 9, implanted circuit 302) comprises at least one active implant electrical contact (Fig. 13, feedthrough pins 328 and implantable housing 304; paras. 0094, 00111-00112, 00115, and 00118); and a percutaneous abutment (Figs. 5 and 13, percutaneous port 700) comprising at least one supracutaneous electrical contact (paras. 0072, 0079, 0081, and 00112; Fig. 5, wherein the proximal end of the feedthrough pin 714 is being construed as the “supracutaneous electrical contact” because it is not surrounded by body tissue) and at least one subcutaneous electrical contact (paras. 0072, 0079, 0081, 00112, wherein the percutaneous port 700 includes feedthrough pins 714 that establish electrical connectivity between the external devices via the proximal end of the feedthrough pins 714 and the implanted circuits 302 via the distal end of the feedthrough pins 714; the distal end of the feedthrough pins 714 is being construed as the “subcutaneous electrical contact”), wherein the percutaneous abutment is configured to be coupled to the active implant to align (Fig. 13 shows the implanted circuits, within the implantable housing 304, aligned with the percutaneous port 700; para. 00112) and place the at least one subcutaneous electrical contact against the at least one active implant electrical contact to establish an electrical connection (Figs. 5; paras. 0018, 0079, and 0081; para. 0025, “implantable components of the percuport system may attach or be connected to the implanted, or distal, side of the feedthrus”; para. 00112 and Fig. 13, wherein the distal end of the feedthrough pin 714 of percutaneous port 700 connects to the proximal end of the feedthrough pins 328 mounted on the housing 304 of the implanted circuits 302 via a suitable implantable wire 329).
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 with the active implant’s electrical contact and the percutaneous abutment’s electrical contacts of Mann et al. 586. Electrical communication may be established between the external and implanted components through the plurality of feedthrough pins located within the percutaneous port, thereby facilitating the transfer of data signals and power links from the external device to the implanted circuits (Mann et al. 586, Abstract; paras. 0027, 00150, and 00152).
While Andersson et al. 013 in view of Mann et al. 586, teaches wherein the active implant comprises at least one electrical contact and wherein a percutaneous abutment comprises supracutaneous and subcutaneous electrical contacts, wherein the active implant electrical contact and subcutaneous electrical contact establish an electrical connection, the combination of Andersson et al. 013 and Mann et al. 586 fail to teach wherein the percutaneous abutment is configured to be decoupled from the active implant to separate the at least one subcutaneous electrical contact from the at least one active implant electrical contact.
Mann et al. 329 teaches an analogous apparatus wherein electrical connectors comprising feedthrough pins configured to be detachably connected to other electrical connectors (Col. 26, lines 9-15 and lines 49-53; Col. 27, lines 1-4).
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 modified the feedthrough pins of Andersson et al. 013 in view of Mann et al. 586 with the feedthrough pins configured to be detachably coupled of Mann et al. 329. Doing so creates a mating assembly that facilitates the establishment of the desired decoupling electrical connection between the fully implantable and semi-implantable components of the cochlear system (Mann et al. 329, Col. 26, lines 9-59).
Regarding claim 3, Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 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; Col. 14, lines 26-36 and lines 59-61).
PNG
media_image1.png
306
401
media_image1.png
Greyscale
Annotated Figure 7
Regarding claim 4, Andersson et al. 013, in the embodiment relied upon above, in view of Mann et al. 586, further in view of Mann et al. 329 teaches the apparatus according to claim 1 as stated above. Andersson et al. 013, in the embodiment relied upon above, fails to teach wherein the active implant comprises an actuator and one or more processors.
Mann et al. 586 further teaches wherein the active implant (Fig. 9, implanted circuits 302) comprises one or more processors (para. 00109).
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 combined the apparatus of Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 with the active implant comprising processing circuitry of Mann et al. 586. The processing circuitry may be utilized to generate stimulation pulses at suitable times and subsequently deliver these pulses to targeted tissue locations (Mann et al. 586, para. 00109).
While Andersson et al. 013, in the embodiment relied upon above, in view of Mann et al. 586, further in view of Mann et al. 329 teaches wherein the active implant comprises one or more processors, the combination of Andersson et al. 013, in the embodiment relied upon above, Mann et al. 586, and Mann et al. 329 fails to teach wherein the active implant comprises an 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 Mann et al. 586, further in view of Mann et al. 329 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).
Regarding claim 5, Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 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).
PNG
media_image2.png
287
382
media_image2.png
Greyscale
Annotated Figure 7A
Regarding claim 7, Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 teaches the apparatus according to claim 1 as stated above. Andersson et al. 013 further teaches an external device (Fig. 2, external device 240; Fig. 4, external device 440; Col. 7, lines 44-45; Col. 15, lines 10-19); however, Andersson et al. 013 fails to teach wherein the external device includes at least one external electrical contact for electrical connection with the least one supracutaneous electrical contact.
Mann et al. 586 further teaches an external device (Fig. 13, external programming device 250 and plug 238; paras. 0098, 00108, and 00111), wherein the external device includes at least one external electrical contact for electrical connection with the least one supracutaneous electrical contact (Figs. 5 and 13; paras. 0079, 0081, and 00112 wherein the proximal ends of the feedthrough pins 714 connect to the wires/conductors terminated inside the plug 720/238, the wires/conductors terminated inside the plug are being construed as the “external device electrical contact”; see Claim 5).
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 Mann et al. 586, further in view of Mann et al. 329 with the external device of Mann et al. 586. Doing so enables different plugs, which are connected to a myriad of external components, to be removably inserted into the percutaneous port for different diagnostic, programming, or recharging purposes (Mann et al. 586, paras. 0019, 0025, 00102-00109).
Regarding claim 8, Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 teaches the apparatus according to claim 1 as stated above wherein the external device is configured to supply power and data to the active implant 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 (Mann et al. 586, Fig. 13, external programming device 250, external power source 240, and replenishable power source 324; paras. 00106-00112).
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 (Fig. 7, abutment 704; Col. 14, lines 26-28),
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), wherein the percutaneous abutment is configured to couple to the bone fixture to align (Fig. 7, abutment 704; Col. 13, line 57; Col. 14, lines 26-29; see Annotated Figure 7).
Andersson et al. 013, in the embodiment relied upon above, 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, in the embodiment relied upon above, fails to teach wherein the percutaneous abutment comprises at least one subcutaneous electrical contact and at least one supracutaneous electrical contact, and the at least one supracutaneous electrical contact is configured to electrically connect to at least one external device electrical contact of an external device; and wherein the active implant comprises a vibratory actuator and at least one active implant electrical contact, wherein the percutaneous abutment is configured to place the at least one subcutaneous electrical contact against the at least one active implant electrical contact to establish an electrical connection, and the percutaneous abutment is configured to be decoupled from the active implant to separate the at least one subcutaneous electrical contact from the at least one active implant electrical contact.
Anderson et al. 013, in a separate embodiment, teaches wherein the active implant comprises an 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 modified the apparatus disclosed in the first embodiment of Andersson et al. 013 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, teaches wherein the active implant comprises a vibratory actuator, Andersson et al. 013, in the separate embodiment relied upon above, fails to teach wherein the percutaneous abutment comprises at least one subcutaneous electrical contact and at least one supracutaneous electrical contact, and the at least one supracutaneous electrical contact is configured to electrically connect to at least one external device electrical contact of an external device; and wherein the active implant comprises at least one active implant electrical contact, wherein the percutaneous abutment is configured to place the at least one subcutaneous electrical contact against the at least one active implant electrical contact to establish an electrical connection, and the percutaneous abutment is configured to be decoupled from the active implant to separate the at least one subcutaneous electrical contact from the at least one active implant electrical contact.
In the same field of endeavor, Mann et al. 586 teaches wherein the percutaneous abutment (Figs. 5 and 13, percutaneous port 700) comprising at least one supracutaneous electrical contact (paras. 0072, 0079, 0081, and 00112; Fig. 5, wherein the proximal end of the feedthrough pin 714 is being construed as the “supracutaneous electrical contact” because it is not surrounded by body tissue) and at least one subcutaneous electrical contact (paras. 0072, 0079, 0081, and 00112, wherein the percutaneous port 700 includes feedthrough pins 714 that establish electrical connectivity between the external devices via the proximal end of the feedthrough pins 714 and the implanted circuits 302 via the distal end of the feedthrough pins 714; the distal end of the feedthrough pins 714 is being construed as the “subcutaneous electrical contact”), and the at least one supracutaneous electrical contact is configured to electrically connect to at least one external device (Fig. 13, external programming device 250, external power source 240, and plug 238; paras. 00108-00111) electrical contact of an external device (Figs. 5 and 13; paras. 0079, 0081, and 00112 wherein the proximal ends of the feedthrough pins 714 connect to the wires/conductors terminated inside the plug 720/238, the wires/conductors terminated inside the plug are being construed as the “external device electrical contact”; see Claim 5); and wherein the active implant (Fig. 9, implanted circuit 302; Fig. 13, implantable housing 304; para. 00112) comprises at least one active implant electrical contact (Fig. 13, feedthrough pins 328), wherein the percutaneous abutment is configured to place the at least one subcutaneous electrical contact against the at least one active implant electrical contact to establish an electrical connection (Figs. 5; paras. 0018, 0079, and 0081; para. 0025, “implantable components of the percuport system may attach or be connected to the implanted, or distal, side of the feedthrus”; para. 00112 and Fig. 13, wherein the distal end of the feedthrough pin 714 of percutaneous port 700 connects to the proximal end of the feedthrough pins 328 mounted on the housing 304 of the implanted circuits 302 via a suitable implantable wire 329).
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 with the active implant’s electrical contact, the external device’s electrical contacts, and the percutaneous abutment’s electrical contacts of Mann et al. 586. Electrical communication may be established between the external and implanted components through the plurality of feedthrough pins located within the percutaneous port, thereby facilitating the transfer of data signals and power links from the external device via the terminated leads in the plug to the implanted circuits via its feedthrough pins (Mann et al. 586, Abstract; paras. 0027, 00150, and 00152).
While a modified Andersson et al. 013 in view of Mann et al. 586, teaches wherein the percutaneous abutment comprising at least one supracutaneous electrical contact and at least one subcutaneous electrical contact, and the at least one supracutaneous electrical contact is configured to electrically connect to at least one external device electrical contact of an external device; and wherein the active implant comprises at least one active implant electrical contact, wherein the percutaneous abutment is configured to place the at least one subcutaneous electrical contact against the at least one active implant electrical contact to establish an electrical connection, the combination of Andersson et al. 013 and Mann et al. 586 fail to teach wherein the percutaneous abutment is configured to be decoupled from the active implant to separate the at least one subcutaneous electrical contact from the at least one active implant electrical contact.
Mann et al. 329 teaches an analogous apparatus wherein electrical connectors comprising feedthrough pins configured to be detachably connected to other electrical connectors (Col. 26, lines 9-15 and lines 49-53; Col. 27, lines 1-4).
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 modified the feedthrough pins of Andersson et al. 013 in view of Mann et al. 586 with feedthrough pins configured to be detachably coupled of Mann et al. 329. Doing so creates a mating assembly that facilitates the establishment of the desired decoupling electrical connection between the fully implantable and semi-implantable components of the cochlear system (Mann et al. 329, Col. 26, lines 9-59).
PNG
media_image1.png
306
401
media_image1.png
Greyscale
Annotated Figure 7
PNG
media_image3.png
310
591
media_image3.png
Greyscale
Annotated Figure 7B
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 Mann et al. 586 and Mann et al. 329, further in view of Jinton et al. (US 2015/0146902).
Regarding claim 2, Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 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 et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 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 Mann et al. 586, further in view of Mann et al. 329 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).
PNG
media_image1.png
306
401
media_image1.png
Greyscale
Annotated Figure 7
PNG
media_image3.png
310
591
media_image3.png
Greyscale
Annotated Figure 7B
Regarding claim 10, Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 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 et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 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 Mann et al. 586, further in view of Mann et al. 329 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).
PNG
media_image4.png
347
633
media_image4.png
Greyscale
Annotated Figure 7C
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andersson et al. 013 in view of Mann et al. 586 and Mann et al. 329, further in view of Khing et al. (US 2017/0180873).
Regarding claim 6, Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 teaches the apparatus according to claim 1 as stated above. Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 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 Mann et al. 586, further in view of Mann et al. 329 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 Mann et al. 586 and Mann et al. 329, further in view of Bergs et al. (US 2015/0117689).
Regarding claim 9, Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 teaches the apparatus according to claim 1 as stated above. Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 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 Mann et al. 586, further in view of Mann et al. 329 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).
PNG
media_image5.png
252
453
media_image5.png
Greyscale
Annotated Figure 6
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 Mann et al. 586.
Regarding claim 11, Andersson et al. 013 teaches a system (Abstract) comprising:
a bone fixture (Fig. 7, bone fixture 702; Col. 14, lines 4-6);
a percutaneous abutment (Fig. 7, abutment 704; Col. 14, lines 26-28);
an active implant coupled to the bone fixture and the percutaneous abutment (as shown in Fig. 7, the piezoelectric material 710A is in direct contact with the abutment 404, abutment fastener – see Annotated Figure 7, and the bone fixture 702; Col. 14, lines 26-36 and lines 59-61) at least partially between a portion of the percutaneous abutment and the bone fixture (see Fig. 7, wherein the piezoelectric material 710A is located between the abutment 704 and bone fixture 702).
Andersson et al. 013, in the embodiment relied upon above, 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, in the embodiment relied upon above, fails to teach a percutaneous abutment comprising at least one supracutaneous electrical contact and at least one subcutaneous electrical contact; wherein the active implant comprises an implant power source, an actuator, a memory, a processor configured to execute instructions stored on the memory to activate the actuator and transmit a vibration to the bone fixture, and an active implant electrical contact configured to electrically couple to the at least one subcutaneous electrical contact; and an external device comprising at least one external device electrical contact configured to electrically couple to the at least one supracutaneous electrical contact, wherein the external device is configured to charge the implant power source and transmit data to the processor of the active implant via electrical coupling between the at least one supracutaneous electrical contact and the at least one external device electrical contact and between the at least one subcutaneous electrical contact and the active implant electrical contact.
Anderson et al. 013, in a separate embodiment, teaches wherein the active implant comprises an 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 modified the system disclosed in the first embodiment of Andersson et al. 013 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, teaches wherein the active implant comprises an actuator, Andersson et al. 013, in the separate embodiment relied upon above, fails to teach a percutaneous abutment comprising at least one supracutaneous electrical contact and at least one subcutaneous electrical contact; wherein the active implant comprises an implant power source, a memory, and a processor configured to execute instructions stored on the memory to activate the actuator and transmit a vibration to the bone fixture, and an active implant electrical contact configured to electrically couple to the at least one subcutaneous electrical contact; and an external device comprising at least one external device electrical contact configured to electrically couple to the at least one supracutaneous electrical contact, wherein the external device is configured to charge the implant power source and transmit data to the processor of the active implant via electrical coupling between the at least one supracutaneous electrical contact and the at least one external device electrical contact and between the at least one subcutaneous electrical contact and the active implant electrical contact.
In the same field of endeavor, Mann et al. 586 teaches wherein a percutaneous abutment (Figs. 5 and 13, percutaneous port 700) comprising at least one supracutaneous electrical contact (paras. 0072, 0079, 0081, 00112; Fig. 5, wherein the proximal end of the feedthrough pin 714 is being construed as the “supracutaneous electrical contact” because it is not surrounded by body tissue) and at least one subcutaneous electrical contact (paras. 0072, 0079, 0081, 00112, wherein the percutaneous port 700 includes feedthrough pins 714 that establish electrical connectivity between the external devices via the proximal end of the feedthrough pins 714 and the implanted circuits 302 via the distal end of the feedthrough pins 714; the distal end of the feedthrough pins 714 is being construed as the “subcutaneous electrical contact”);
wherein the active implant (Fig. 9, implanted circuit 302; Fig. 13, implantable housing 304; para. 00112) comprises an implant power source (Fig. 13, replenishable power source 324; para. 00108) a memory (para. 00109), and a processor (para. 00109) configured to execute instructions stored on the memory to generate stimulation pulses and deliver stimulation pulses to desired target tissue locations (para. 00109), and an active implant electrical contact (Fig. 13, feedthrough pins 328) configured to electrically couple to the at least one subcutaneous electrical contact (paras. 0081 and 00112, wherein the proximal end of the implantable housing’s feedthrough pins 328 are connected to the distal ends of the percutaneous port’s feedthrough pins 714 via an implantable wire 329); and
an external device (Fig. 13, external programming device 250 and plug 238; para. 00111) comprising at least one external device electrical contact configured to electrically couple to the at least one supracutaneous electrical contact (Figs. 5 and 13; paras. 0079, 0081, and 00112 wherein the proximal ends of the feedthrough pins 714 connect to the wires/conductors terminated inside the plug 720/238, the wires/conductors terminated inside the plug are being construed as the “external device electrical contact”, the wires/conductors terminated inside the plug are being construed as the “external device electrical contact”; see Claim 5),
wherein the external device is configured to charge the implant power source (Fig. 13, replenishable power source 324; para. 00108) and transmit data to the processor of the active implant via electrical coupling between the at least one supracutaneous electrical contact and the at least one external device electrical contact and between the at least one subcutaneous electrical contact and the active implant electrical contact (Fig. 13, external programming device 250 and external power source 240; paras. 00106-00112).
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 system of a modified Andersson et al. 013 with the percutaneous abutment comprising supracutaneous and subcutaneous electrical contact; active implant comprising an implant power source, memory, and processor wherein the active implant comprises an electrical contact; and an external device comprising electrical contact, further configured to charge the implant power source and transmit data to the active implant via their respective electrical contacts of Mann et al. 586. This configuration allows a user to selectively establish direct electrical connectivity between external components and implanted components. Furthermore, the feedthrough pins within the percutaneous port enable a user to program, perform diagnostics and/or recharge the implantable circuits via external devices connected to selective plugs (Mann et al. 586, Fig. 9; paras. 0047 and 00106-00114).
PNG
media_image1.png
306
401
media_image1.png
Greyscale
Annotated Figure 7
Regarding claim 13, a modified Andersson et al. 013 in view of Mann et al. 586 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 via electrical couplings 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 active implant electrical contact of the active implant (Mann et al. 586, Fig. 13, external programming device 250 , external power source 240, replenishable power source 324; paras. 00106-00112).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Andersson et al. 013 in view of Mann et al. 586, further in view of Asfaw et al. (US 2017/0353784).
Regarding claim 14, a modified Andersson et al. 013 in view of Mann et al. 586 teaches the system according to claim 11 as stated above. A modified Andersson et al. 013 in view of Mann et al. 586 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 a modified Andersson et al. 013, in view of Mann et al. 586 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 Mann et al. 586 and Mann et al. 329, 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 Mann et al. 586, further in view of Mann et al. 329 teaches the apparatus according to claim 16 as stated above. Mann et al. 586 further teaches the external device (Fig. 9; Fig. 13, external programming device 250, external power source 240, and plug 238; paras. 00108-00111), wherein the external device comprises a power source (Fig. 13, external power source 240; para. 00110);
wherein the external device is electrically coupled to the active implant (Fig. 9, implanted circuits 302; Fig. 13, implantable housing 304) via electrical couplings (Abstract; para. 0081, wherein the feedthrough pins located in the percutaneous port facilitate electrical connectivity between the implanted circuits and the external components) between the at least one supracutaneous electrical contact (paras. 0072, 0079, 0081, 00112; Fig. 5, wherein the proximal end of the feedthrough pin 714 is being construed as the “supracutaneous electrical contact” because it is not surrounded by body tissue) of the percutaneous abutment (Fig. 13, percutaneous port 700) and the at least one external device electrical contact (Figs. 5 and 13; paras. 0079, 0081, and 00112 wherein the proximal ends of the feedthrough pins 714 connect to the wires/conductors terminated inside the plug 720/238, the wires/conductors terminated inside the plug are being construed as the “external device electrical contact”; see Claim 5) of the external device and between the at least one subcutaneous electrical contact (paras. 0072, 0079, 0081, 00112, wherein the percutaneous port 700 includes feedthrough pins 714 that establish electrical connectivity between the external devices via the proximal end of the feedthrough pins 714 and the implanted circuits 302 via the distal end of the feedthrough pins 714; the distal end of the feedthrough pins 714 is being construed as the “subcutaneous electrical contact”) of the percutaneous abutment and the at least one active implant electrical contact (Fig. 13, feedthrough pins 328) of the active implant (paras. 0081 and 00112, wherein the proximal end of the implantable housing’s feedthrough pins 328 are connected to the distal ends of the percutaneous port’s feedthrough pins 714 via an implantable wire 329).
Mann et al. fails to teach wherein the external device comprises a microphone and sound processor; wherein the external device is mechanically coupled to the percutaneous abutment; and wherein the sound processor is configured to cause the vibratory actuator to actuate.
A modified Andersson et al. 013 further teaches wherein the external device comprises a microphone and sound processor (Fig. 2, external device 240, sound input element 226, sound processor 227); wherein the sound processor is configured to cause the vibratory actuator to actuate (Col. 5, lines 56-67 and Col. 6, lines 1-23).
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 combined the apparatus of Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 with the external device comprising a sound processor and sound input element of Andersson et al. 013. This configuration enables the microphone to convert received sound signals into electrical signals. These electrical signals may then be processed by the sound processor to generate control signals to cause the actuator to vibrate, thereby providing stimulation to the auditory nerve of the recipient (Andersson et al. 013, Col. 5, lines 56-67 and Col. 6, lines 1-15).
While Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 teaches the external device comprising a sound input element and sound processor, wherein the sound processor is configured to cause the vibratory actuator to actuate, the combination of Andersson et al. 013, Mann et al. 586, and Mann et al. 329 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 Mann et al. 586, further in view of Mann et al. 329 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 Mann et al. 586, Mann et al. 329, and Andersson et al. 823, further in view of Khing et al.
Regarding claim 18, Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 teaches the apparatus according to claim 16 as stated above. Mann et al. 586 further teaches the external device, (Fig. 9; Fig. 13, external programming device 250, external power source 240, and plug 238; paras. 00108-00111), wherein the external device comprises a power source (Fig. 13, external power source 240; para. 00110); wherein the external device is configured to electrically couple to the active implant (Fig. 9, implanted circuits 302; Fig. 13, implantable housing 304) via electrical couplings (Abstract; para. 0081, wherein the feedthrough pins located in the percutaneous port facilitate electrical connectivity between the implanted circuits and the external components) between the at least one supracutaneous electrical contact (paras. 0072, 0079, 0081, 00112; Fig. 5, wherein the proximal end of the feedthrough pin 714 is being construed as the “supracutaneous electrical contact” because it is not surrounded by body tissue) of the percutaneous abutment (Fig. 13, percutaneous port 700) and the at least one external device electrical contact (Figs. 5 and 13; paras. 0079, 0081, and 00112 wherein the proximal ends of the feedthrough pins 714 connect to the wires/conductors terminated inside the plug 720/238, the wires/conductors terminated inside the plug are being construed as the “external device electrical contact”; see Claim 5) of the external device and between the at least one subcutaneous electrical contact (paras. 0072, 0079, 0081, 00112, wherein the percutaneous port 700 includes feedthrough pins 714 that establish electrical connectivity between the external devices via the proximal end of the feedthrough pins 714 and the implanted circuits 302 via the distal end of the feedthrough pins 714; the distal end of the feedthrough pins 714 is being construed as the “subcutaneous electrical contact”) of the percutaneous abutment and the at least one active implant electrical contact (Fig. 13, feedthrough pins 328) of the active implant (paras. 0081 and 00112, wherein the proximal end of the implantable housing’s feedthrough pins 328 are connected to the distal ends of the percutaneous port’s feedthrough pins 714 via an implantable wire 329) to charge an implanted power source (Fig. 13, replenishable power source 324; para. 00108) of the active implant from the external device power source (Fig. 13, external power source 240; paras. 00106-00112).
Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 fails to teach wherein the external device is configured to mechanically couple to the percutaneous abutment; 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 configured to mechanically couple 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 Mann et al. 586, further in view of Mann et al. 329 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).
While Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 and Andersson et al. 823 teach wherein the external device is configured to mechanically couple to the percutaneous abutment, the combination of Andersson et al. 013, Mann et al. 586, Mann et al. 329, and Andersson et al. 823 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, 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 Mann et al. 586, further in view of Mann et al. 329 and Andersson et al. 823 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 Mann et al. 586 and Mann et al. 329, further in view of Asfaw et al.
Regarding claim 19, Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 teaches the apparatus according to claim 16 as stated above. Andersson et al. 013, in view of Mann et al. 586, further in view of Mann et al. 329 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 Mann et al. 586, further in view of Mann et al. 329 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
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 BROGAN R LANDEEN whose telephone number is (571)272-1390. The examiner can normally be reached Monday - Friday 8:30am - 6:00pm.
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, Jennifer Robertson can be reached at (571) 272-5001. 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.
/B.R.L./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
Prosecution Insights