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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 7th, 2026, has been entered.
Response to Amendment
The claims filed on January 7th, 2026, have been entered. Claims 12-19, 25-28, and 30-36 remain pending in the Application. Claim 29 has been canceled by the Applicant. The claim amendments overcome the previous claim objections.
Response to Arguments
Applicant's arguments filed January 7th, 2026, have been fully considered but they are not persuasive.
Applicant argues that Berger (Pub. No. 2008/0255556) in view of Kaufmann et al. (Pub. No. 2025/0235693) does not disclose the controller configured to monitor at least one signal received from the electrically conductive conduit because Kaufmann et al. does not disclose engagement unit 112 is an electrically conductive conduit, and instead discloses 112 as a mechanical coupling of the user control device 120 to the implant position manipulator (IPM) unit 110, citing [0014], [0084], [0095], and FIGS. 2A-5B. Examiner respectfully disagrees. [0080] of Kaufmann et al. discloses that 120 may be an electromagnetic device engaged with IPM unit 110 via the engagement unit 112 to cause movement of the elongate member 141 to deliver implant 140, and that 120 can receive information from sensors on 110 about the implant. For 120 to receive electrical signals from 110 through 112, 112 needs to be a structure which conducts electrical signals, which makes 112 an electrically conductive conduit. Furthermore, the citations to [0014], [0084], and [0095] are directed to other embodiments than the embodiment being cited, as are FIGs. 2A-5B.
Applicant further argues that the user control device 120 of Kaufmann et al. is not disclosed as being configured to monitor at least one signal received from the electrically conductive conduit, the at least one signal indicative of a status of the body portion during insertion of the body portion into the bone portion because 120 is not disclosed as receiving signals from an electrically conductive conduit. Examiner respectfully disagrees. As pointed out above, 112 is conducting electrical signals from 110 to 120, and the signals conducted are regarding properties of the implant such as force, location, speed, electrocochleography, neural response telemetry, cochlear response telemetry, auditory brainstem responses, and other parameters ([0080]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 12-19, 25-28, and 30-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berger (Pub. No. 2008/0255556) in view of Kaufmann et al. (Pub. No. 2025/0235693).
Regarding claim 12, Berger discloses an apparatus ([0050]; FIGs. 1-8) comprising:
an electrically conductive conduit (80; FIG. 13);
a bone screw (20) comprising:
a body portion (26) configured to be rotated about an axial direction to drill into bone tissue outside and adjacent to a vestibular cavity of a recipient ([0031] 20 is a bone screw, and 26 is capable of being drilled into bone tissue by axial rotation);
a head portion (22) configured to be mechanically engaged and rotated about the axial direction to drill the body portion into the bone tissue ([0052] 22 has cutouts 25, which are torque-receiving means of being rotated to drill 26 into bone tissue); and
an electrically conductive connector portion ([0051] 20 can be made out of conductive material with an inner insulated sleeve) configured to be in electrical communication with an electrically conductive conduit ([0058] 20 can have a portion between 22 and 26 that communicates with an external lead 80; FIG. 13) while the bone screw portion and the head portion are rotated about the axial direction ([0058] 20 can be drilled while 80 is touching 20).
Berger does not disclose a controller configured to be in electrical communication with the electrically conductive conduit and configured to monitor at least one signal received from the electrically conductive conduit, the at least one signal indicative of a status of the body portion during insertion.
Kaufmann et al. teaches an apparatus (100; FIG. 1; [0071]) comprising a body screw ([0078] fixation member may be a screw that connects the IPM unit 110 to the body), an electrically conductive conduit (112), and a controller (120) configured to be in electrical communication with the electrically conductive conduit ([0080] engagement unit 112 connects the control device 120 to the IPM unit 110 to move the implant 140 to and from the body based on sensor data received by 110, and 120 provides feedback to allow adjustments to be sent from 120 through 112 to 110 to control the deployment or removal) and configured to monitor at least one signal received from the electrically conductive conduit ([0080] 112 sends the signals from 110 to 120), the at least one signal indicative of a status of the body portion during insertion ([0080] 120 receives electrophysical information in real-time from the implant site, including measurement data related to implant positioning) for the purpose of alerting the surgeon to withhold further implant motion, and then to adjust the implant insertion trajectory or system motion parameters as needed to avoid damaging the body tissue ([0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the apparatus of Berger to have a controller, as taught by Kaufmann et al., for the purpose of alerting the surgeon to withhold further implant motion, and then to adjust the implant insertion trajectory or system motion parameters as needed to avoid damaging the body tissue.
Regarding claim 13, Berger further discloses the connector portion is between the body portion and the head portion (FIG. 13: 80 is between 22 and 26), the connector portion configured to be in rotatable communication with a clip portion of the electrically conductive conduit (FIG. 13: 80 has washer 82 which is in communicable contact with the clip portion 84 of 80).
Regarding claim 14, Berger further discloses the head portion comprises a recess (25) configured to be mechanically engaged and rotated by a portion of a driving system such that the body portion and the head portion are rotated about the axial direction ([0052] 22 has cutouts 25, which are torque-receiving means of being rotated to drill 26 into bone tissue).
Regarding claim 15, Berger further discloses a perimeter of the head portion (FIG. 1: 25 forms the perimeter of 22) is configured to be mechanically engaged and rotated by a portion of a driving system such that the body portion and the head portion are rotated about the axial direction ([0052] 22 has cutouts 25, which are torque-receiving means of being rotated to drill 26 into bone tissue).
Regarding claim 16, Berger further discloses a threaded hole (32; FIG. 3) extending along the axial direction through the head portion and at least partially through the body portion (FIG. 3: 32 extends axially through 22 and part of 26), the apparatus further comprises:
a first component (40; FIG. 4; [0052]) comprising:
a first threaded screw (42) within the threaded hole and configured to be removed from the threaded hole (FIGs. 3-4: 42 fits within 32 and can be removed from 32); and
at least one electrically conductive leaf spring (59) configured to be in electrical communication with a portion of the driving system when the perimeter is mechanically engaged by the portion of the driving system ([0053] 59 communicates with the system that drives 26 into bone); and
a second component ([0053] 40 is a casing for the battery component, which has to be replaced when the battery runs out if rechargeable lithium batteries are not used in the alternative embodiment; therefore, a first 40 could be removed and replaced with a second 40, which would be the second component) comprising:
a second head portion (second 41); and
a second threaded screw (second 42) configured to be screwed into the threaded hole after the first threaded screw is removed from the threaded hole ([0053] after the first 42 is removed, the second 42 would be screwed into 32).
Regarding claim 17, Berger further discloses a third component (82) configured to be sandwiched between the head portion and the second head portion (FIG. 13: 82 is between 22 and 41, which could be the second 41 after replacing the battery) and at least partially encircling the second threaded screw in the threaded hole (FIG. 13: 82 encircles 42).
Regarding claim 18, Berger further discloses a recess (32) extending along the axial direction through the head portion and at least partially through the body portion (FIG. 3: 32 extends axially through 22 and part of 26);
a first component (40; FIG. 4; [0052]) comprising:
a first spring-loaded fitting (58) that is press-fit within the recess and configured to be removed from the recess ([0053] 58 is press-fit by 59 within 32, and can be removed when the battery is replaced; and
at least one electrically conductive leaf spring (59) configured to be in electrical communication with a portion of the driving system when the perimeter is mechanically engaged by the portion of the driving system ([0053] 59 communicates with the system that drives 26 into bone); and
a second component ([0053] 40 is a casing for the battery component, which has to be replaced when the battery runs out if rechargeable lithium batteries are not used in the alternative embodiment; therefore, a first 40 could be removed and replaced with a second 40, which would be the second component) comprising:
a second head portion (second 41); and
a second spring-loaded fitting (second 58) configured to be press-fit into the recess after the first spring-loaded fitting is removed from the recess ([0053] the second 58 would be compressed into 32 when the second 40 is installed).
Regarding claim 19, Berger further discloses an electrically insulating cap (40) configured to electrically insulate at least the head portion from surrounding biological materials ([0053] 40 is insulated to protect the battery and other circuitry from the tissue input).
Regarding claim 25, Berger further discloses the connector portion is between the body portion and the head portion (FIG. 13: 80 is between 22 and 26) and the electrically conductive conduit comprises a clip portion configured to be in rotatable communication with the connector portion (FIG. 13: 80 has washer 82 which is in communicable contact with the clip portion 84 of 80).
Regarding claim 26, Berger as modified by Kaufmann et al. further discloses the controller is further configured to transmit electrical stimulation signals to the electrically conductive conduit after the body portion is inserted into the bone tissue (Kaufmann et al. [0117] the IPM unit 110 can generate electrostimulation impulses to the tissue after implantation; since [0080] 120 controls 110, 120 is configured to cause 110 to transmit electrical stimulation through 112 after implantation).
Regarding claim 27, Berger as modified by Kaufmann et al. further discloses the controller is further configured to generate a signal for stopping the insertion of the bone screw portion in response to receiving at least one feedback signal that is indicative of a predetermined insertion of the bone screw portion (Kaufmann et al. [0106] display and audio feedback are provided to signal the user that the position of the implant has exceeded maximum parameter values; [0080] these feedback signals are controlled by 120).
Regarding claim 28, Berger as modified by Kaufmann et al. further discloses the predetermined insertion corresponds to a predetermined distance between the bone screw portion and an inner wall of the vestibular cavity (Kaufmann et al. [0080] the position readings are based on predetermined values for the procedure, such as within the vestibular cavity to avoid reaching the inner wall).
Regarding claim 30, Berger as modified by Kaufmann et al. further discloses the at least one feedback signal is indicative of an electrical impedance between the apparatus and a predetermined tissue portion of the recipient (Kaufmann et al. [0080] the feedback signals can be based on electrophysical information, such as changes in electrical impedance between the implant 140 and the tissue that 140 is being inserted into).
Regarding claim 31, Berger as modified by Kaufmann et al. further discloses the at least one feedback signal comprises at least one electrophysiological signal indicative of a response by the recipient to electrical stimulation applied to the electrically conductive connector portion (Kaufmann et al. [0080] the feedback signals can be based on electrophysical information, and [0117] this can include responses to electrostimulation conducted by the implant).
Regarding claim 32, Berger further discloses the body portion is configured to not extend into the vestibular cavity when implanted ([0054] 20 is capable of being implanted in bone, where whether 20 extends into the vestibular cavity will depend on implant depth; therefore, 20 is capable of not extending into the vestibular cavity when implanted).
Regarding claim 33, Berger further discloses the body portion is configured to self-drill into the bone tissue ([0018] the bone screw is a self-operating implant).
Regarding claim 34, Berger further discloses the body portion is configured to be implanted sufficiently close to a vestibular nerve of the recipient such that the vestibular nerve are stimulated by a predetermined current applied to the electrically conductive connector portion ([0053] the current provided by 20 is at a preferred value of 20 micro amperes, and is capable of being applied to the vestibular nerve because 20 is an implantable bone screw).
Regarding claim 35, Berger further discloses the bone screw is configured to not extend into the vestibular cavity when implanted ([0054] 20 is capable of being implanted in bone, where whether 20 extends into the vestibular cavity will depend on implant depth; therefore, 20 is capable of not extending into the vestibular cavity when implanted).
Regarding claim 36, Berger as modified by Kaufmann et al. further discloses the electrically conductive conduit is flexible (Berger FIGs. 12-13: 80 is a flexible lead that can be twisted around various parts of 20) and is configured to be in electrical communication with the electrically conductive connector portion (Berger [0058] and FIG. 13: 80 is wrapped around 20 to create an electrical field) and with the controller (Kaufmann et al. [0080] 120 is connected to the implant to receive electrical signals, such as in Berger [0058] variances in the electrical field that indicate position, force, and other factors) during insertion of the body portion into the bone tissue and after the body portion is inserted (Berger [0058] and Kaufmann et al. [0080] the communication between the elements is constant throughout and after insertion).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771