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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/17/25 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 2, 4-5, 8-9, 11-14, 23-24, 26-29 and 31-34 have been considered but are moot because of new grounds of rejection as discussed below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 11, 32 and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gibson et al. US 2006/0235500.
Regarding claim 11, Gibson et al. disclofses an apparatus 10 comprising: an elongate carrier 11 (figure 1, paragraph 0134) configured to be implanted proximate a vestibular organ of a recipient (configured to be inserted to the desired location); at least one vestibular electrode 12 coupled to the elongate carrier (figure 1, paragraph 0134); and an optical fiber bundle of one or more optical fibers (paragraph 0020), wherein the optical fiber bundle is coupled to the elongate carrier such that implantation of the elongate carrier can be monitored via the optical fiber bundle (paragraph 0023, one or more optic fibers allow illumination and visualization, or monitoring, at the surgical site) and the optical fiber bundle is removable from the elongate carrier while a stylet is coupled to the elongate carrier such that the optical fiber bundle and the stylet are individually removable from the elongate carrier (paragraph 0049, 0050; optic fibers or stiffening element may be removed from the lumen during or following insertion of the elongate carrier member). Examiner notes that two optic fibers members or stiffening member stylets may be removably inserted within the carrier within a first and second lumen (paragraph 0181), therefore, one optical fiber bundle stylet may be removed while the other “stylet” remains or may be individually removed (for example, paragraph 0150).
Regarding claim 32, Gibson et al. discloses wherein the optical fiber bundle is inserted within a lumen extending within the elongate carrier to couple the optical fiber bundle to the elongate carrier, and the stylet is exterior to the lumen (paragraph 0181; two optic fibers members or stiffening member stylets may be removably inserted or coupled within the carrier within a first and second lumen, therefore, the stylet within one lumen will be exterior to the second lumen holding the second optical fiber bundle stylet).
Regarding claim 33, Gibson et al. discloses wherein the optical fiber bundle 15 extends to a distal end of the elongate carrier (figure 1, distal end 13), the apparatus comprising: a light source disposed at a proximal end of the elongate carrier and configured to deliver light through the optical fiber bundle to direct light out and illuminate an area around the distal end of the elongate carrier to provide a visualization of a position of the elongate carrier during implantation (paragraph 0023, 0054-0057, 109; light source received at a proximal end of optic fiber and directs through to the leading end), and the optical fiber bundle is configured to reflect the visualization to the proximal end (paragraph 0055, 0056, reflected through the optic fibers from an object illuminated); and an image sensor configured to capture the visualization reflected by the optical fiber bundle to help visualize the position of the elongate carrier for monitoring implantation of the elongate carrier via the optical fiber bundle (paragraphs 0054-0057; camera lens detects image and used in real time footage being reviewed during or after the procedure, light illuminates adjacent the distal tip, eyepiece and/or camera receive light reflected from the object illuminated, imaged detected by the camera lens during implantation and reduce trauma).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bendett et al. US 8,632,577 in view of Kuzma US 6968238 in view of Griffin, III et al. US 5888577.
Regarding claims 1 and 34, Bendett et al. discloses a method, comprising: making a vestibular electrode array available for use (column 1, lines 56-67; stimulation of the nerves of the vestibular system for stimulation of nerves of the inner ear or related bodily systems), but fails to disclose guiding, via a stylet pre-formed to have a curved portion proximate to a distal end, the vestibular electrode array to a target vestibular treatment location in a recipient by twisting the stylet about an axis of extension of the stylet within the vestibular electrode array.
Kuzma teaches a stylet 154 being curved (figure 8B, stylet wire 154 curved through with portion 151 of introducer), the electrode array 320 to a target treatment location in a recipient by twisting the stylet about an axis of extension of the stylet within the electrode array (column 15, lines 34-55; tube 152 of tool may be slightly bent and can swivel, or twist, at its base to in facilitate insertions of the electrode array to the target treatment location, thereby twisting the stylet wire 154), wherein the stylet is decoupled from the vestibular electrode array (figure 8A), and the method comprises coupling the stylet to the vestibular electrode array to induce the vestibular electrode array to curl (figure 8A, figure 14, column 16, line 51-56; the electrode array facilitates bending or curling within the desired location once coupled with the insertion stylet), but fails to explicitly disclose the stylet being pre-formed to have a curved portion.
Griffin, III et al. discloses an electrode array comprising a stylet 40 received within the flexible member 12 comprising electrodes 46 and 48 (figure 2), it is possible to utilize a straight or curved stylet as desired, which may be moved into and out of the flexible member or electrode array 12 and rotated to steer the distal end of the electrode array and catheter (column 4, lines 44-59).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bendett et al. with guiding, via a stylet the vestibular electrode array to a target vestibular treatment location in a recipient by twisting the stylet about an axis of extension of the stylet within the vestibular electrode array, as taught by Kuzma, to position the electrode array, and to provide a pre-formed curved stylet wire as known in the art to provide a straight or curved stylet, as taught by Griffin, III et al. for insertion to the desired location by rotating or twisting as required to steer the catheter or electrode array.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bendett et al. US 8,632,577 in view of Kuzma US 6968238 in view of Griffin, III et al. US 5888577, and further in view of XU et al. US 2016/0199638.
Regarding claim 2, Bendett et al. in combination discloses the method essentially as claimed as discussed above, but fails to disclose further comprising: mounting a proximal portion of the stylet to a recipient's skull after guiding the vestibular electrode array to the target vestibular treatment location in the recipient.
XU et al. teaches an electrode array 195 being inserted within an implantable lead 190, the lead
being placed within a recess of the human skull (paragraph 0047) and anchored or mounted with flag extensions (720, 722, 724) to preserve the configuration of the body to allow for some motion between
the processor and the electrode array (paragraph 0047), the flexible body may form anchor points that
may be attached and secured to surrounding tissue or provide an insertion depth marker (paragraph
0056).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective
filing date of the invention to modify Bendett et al. by mounting a proximal portion of the stylet to a
recipient's skull after guiding the vestibular electrode array to the target vestibular treatment location in
the recipient, as taught by XU et al. to allow for the lead or stylet holding the electrode array to attach
and secure to surrounding tissue or provide an insertion depth marker.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bendett et al. US 8,632,577 in view of Kuzma US 6968238 in view of Griffin, III et al. US 5888577 and further in view of Buytaert US 2022/0273952.
Regarding claim 4, Bendett et al. in combination discloses a method as disclosed as discussed above, but fails to explicitly disclose forming an opening in a stapes footplate of the recipient, and wherein guiding, via the stylet, the vestibular electrode array to the target vestibular treatment location in the recipient includes: guiding the vestibular electrode array through the opening in the stapes footplate.
Buytaert teaches a vestibular electrode array (paragraph 0035), and forming an opening in a stapes footplate of the recipient, and guiding the vestibular electrode array through the opening in the stapes footplate (paragraph 0035, inserted through an anterior opening such as a stapedotomy).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bendett et al. by guiding the vestibular electrode array through the opening in the stapes footplate, as taught by Buytaert and known in the art to provide an opening such as a stapedotomy for insertion of the plurality of electrodes into the target location.
Claim(s) 5 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bendett et al. US 8,632,577 in view of Kuzma US 6968238 in view of Griffin, III et al. US 5888577 and further in view of Tortonese et al. US 9211403.
Regarding claim 5, Bendett et al. discloses the method essentially as claimed, but fails to disclose wherein the guiding is performed at least in part by a robotic positioner.
Tortonese et al. teaches wherein the guiding is performed at least in part by a robotic positioner (figure 14, column 13, lines 1-13; system 1400 for automatic insertion of the electrode array, comprising an insertion tool 1430 supported by the articulated arm 1410 and base, or alternatively may be held manually by the surgeon), the system may operate by fully autonomous insertion or semi-autonomous insertion (column 12, lines 44-46).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bendett et al. with guiding being performed at least in part by a robotic positioner, as taught by Tortonese et al. to provide a system that may operate by fully autonomous insertion or semi-autonomous insertion.
Regarding claim 8, Bendett et al. in combination discloses the method essentially as claimed including optical fibers to facilitate the placement process (for example, column 5, lines 44-50) and monitoring a position via an optical fiber bundle of one or more optical fibers (column 5, lines 6-8; detects nerve signals), but fails to explicitly disclose monitoring a position.
Tortonese et al. teaches monitoring position via an optical fiber bundle of one or more optical fibers (column 10, lines 48-65; sensor 1100 including an optical fiber, distances corresponding with wavelengths of light being reflected, column 11, lines 37-50; optical fiber senses and controls the placement of the electrode array, and provide feedback that allows appropriate control of the pull wires during insertion).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify Bendett et al. by monitoring a position via an optical fiber bundle of one or more optical fibers, as taught by Tortonese et al., to sense and control the placement of the electrode array and provide appropriate feedback for insertion.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bendett et al. US 8,632,577 in view of Kuzma US 6968238 in view of Griffin, III et al. US 5888577 in view of Tortonese et al. US 9211403 and further in view of Gibson et al. US 2006/0235500 and Dadd et al. WO 02/28473.
Regarding claim 9, Bendett et al. in combination discloses the method essentially as claimed as discussed above, but fail to explicitly disclose wherein the optical fiber bundle is disposed in a lumen of the vestibular electrode array; and wherein the method further comprises: removing the optical fiber bundle from the lumen to detach the optical fiber bundle from the vestibular electrode array; and sealing an opening of the lumen with a sealant or a plug.
Gibson et al. discloses wherein the optical fiber bundle 15 is disposed in a lumen 14 of the vestibular electrode array (figure 1); and wherein the method further comprises: removing the optical fiber bundle from the lumen to detach the optical fiber bundle from the vestibular electrode array (paragraph 0049, 0050; optic fibers or stiffening element may be removed from the lumen during or following insertion of the elongate carrier member). Examiner notes that two optic fibers members or stiffening member stylets may be inserted within the carrier within a first and second lumen (paragraph 0181), therefore, one optical fiber bundle stylet may be removed while the other “stylet” remains (paragraph 0150).
Dadd et al. teaches a method comprising an assembly 10 comprising an electrode array 15
for insertion and an optical bundle 15, and sealing an opening of the lumen with a sealant or a
plug19 (figure 1, plug 19 to seal lumen 17) to close and seal the opening of the lumen (page 10, lines 12-17).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bendett et al. in combination by removing the optical fiber bundle from the electrode array to detach the optical bundle, as taught by Gibson et al. to allow for the desired positioning at the target location, and plug or seal the opening, as taught by Dadd et al., as known in the art to close the lumen and seal the opening.
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gibson et al. US 2006/0235500 and further in view of Bendett et al. US 8,632,577.
Regarding claims 12 and 13, Gibson et al. discloses an apparatus essentially as claimed as discussed above, but fails to disclose the elongate carrier defines a groove at least partially along a side of the elongate carrier and configured to receive the optical fiber bundle to couple the optical fiber bundle to the elongate carrier, wherein the elongate carrier comprises one or more spans over the groove; and wherein the one or more spans are configured to retain the optical fiber bundle in the groove.
Bendett et al. teaches an apparatus comprising an elongate carrier defining a groove at least partially along a side of the elongate carrier (column 3, line 54-column 4, line 2; optical devices and methods for mounting optical fibers using a silicon V-groove to precisely align and space the optical fibers to improve optical coupling), or in another embodiment wherein the elongate carrier comprises one or more spans over the groove and wherein the one or more spans are configured to retain the optical fiber bundle in the groove (column 7, lines 36-51; optical fiber within a sleeve or elongate carrier spirally wound, providing one or more spans to retain the optical fiber).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gibson et al. US 2006/0235500 and further in view of XU et al. US 2016/0199638.
Regarding claim 14, Gibson et al. discloses the apparatus essentially as claimed as discussed above, but fails to disclose wherein one or more components of the apparatus are radiopaque.
XU et al. teaches an implantable lead 192 including a lead body or elongate carrier 190, and an electrode array 195 (paragraph 0023), the apparatus comprising one or more components being radiopaque to serve as a reference for imaging (paragraph 0039).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Gibson et al. with a radiopaque component, as taught by XU et al. to serve as a reference for imaging.
Claim(s) 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bendett et al. US 8,632,577 in view of Kuzma US 6968238 in view of Griffin, III et al. US 5888577 and in view of Ramos de Miguel, Sr. et al. US 2018/0140829.
Regarding claims 23 and 24, Bendett et al. discloses a method, comprising: making a vestibular electrode array available for use into a recipient (column 1, lines 56-67; stimulation of the nerves of the vestibular system for stimulation of nerves of the inner ear or related bodily systems), but fails to disclose guiding with a stylet pre-formed to have a curved portion while the stylet is separated from the vestibular electrode array, the guiding wherein the guiding includes providing a stimulus using at least one vestibular electrode of the vestibular electrode array; measuring a neural or myogenic response to the provided stimulus; and modifying the position of the vestibular electrode array based on the neural or myogenic response, wherein guiding the vestibular electrode array to the target vestibular treatment
location in the recipient further includes: obtaining a fluoroscopic image showing a location of a
radiopaque marker of the vestibular electrode array relative to the target vestibular treatment location.
Griffin, III et al. discloses an electrode array comprising a stylet 40 received within the flexible member 12 comprising electrodes 46 and 48 (figure 2), it is possible to utilize a straight or curved stylet as desired, which may be moved into and out of the flexible member or electrode array 12 and rotated to steer the distal end of the electrode array and catheter (column 4, lines 44-59), the curved portion engaging with the elongate member or electrode array 12 (figure 2).
Ramos de Miguel, Sr. et al. teaches a method for inserting an electrode array 145 to a treatment
location (paragraph 0008), wherein the guiding includes providing a stimulus using at least one vestibular electrode of the vestibular electrode array; measuring a neural or myogenic response to the
provided stimulus and modifying the position of the vestibular electrode array based on the neural or
myogenic response (paragraph 0164, 0165; some embodiments utilize neural responses to further
provide confirmation of the electrode position and add information about the electrode position, and
may be insertion position may be corrected if necessary), wherein the guiding of the electrode array to
the treatment location includes: obtaining a fluoroscopic image showing a location of a radiopaque
marker of the electrode array relative to the target treatment location (paragraph 0161, determining
the position of the electrode array within the treatment location using radiology imaging methods such
as fluoroscopy).
Therefore, it would have been obvious to one having ordinary skill in the art to modify Bendett et al. with a pre-formed curved stylet wire, as taught by Griffin, III et al. as known in the art to provide a straight or curved stylet for insertion and placement of the elect to the desired location, and measuring a neural or myogenic response to the provided stimulus and modifying the position of the vestibular electrode array based on the neural or myogenic response if correction is required, and with a fluoroscopic image showing a radiopaque marker, as taught by Ramos de Miguel, Sr. et al., to determine a position of the electrode array within the treatment location and properly position as required for the procedure.
Claim(s) 26 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bendett et al. US 8,632,577 in view of Kuzma US 6968238 in view of Griffin, III et al. US 5888577 and in view of Ramos de Miguel, Sr. et al. US 2018/0140829 and further in view of Waldmann US 2005/0131272.
Regarding claims 26 and 27, Bendett et al. in combination discloses the method essentially as
described as discussed above, but fails to disclose monitoring hearing of the recipient using
electrocochleography, or providing a visual indication or an audible indication of the position.
Waldmann teaches a method comprising: guiding an implant to a target treatment location in a
recipient (figure 4, paragraph 0035), and further teaches monitoring hearing of the recipient using
electrocochleography to provide electrophysiological measurements (paragraph 0012), or providing a
visual indication or an audible indication of the position to indicate to a user to indicate an optimal
position has been achieved (paragraph 0016).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective
filing date of the invention to modify Bendett et al. in combination by monitoring hearing of the recipient using electrocochleography, as taught by Waldmann to provide measurements, or providing a visual indication or an audible indication of the position, as taught by Waldmann, to indicate to a user that an optimal position has been achieved.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bendett et al. US 8,632,577 in view of Kuzma US 6968238 in view of Griffin, III et al. US 5888577 and in view of Ramos de Miguel, Sr. et al. US 2018/0140829 in view of Waldmann US 2005/0131272 and further in view of Haller et al. US 2010/0114288.
Regarding claim 28, Bendett et al. in combination discloses the method essentially as disclosed as discussed above, but fails to disclose providing the audible indication of the position via a change in pitch of an audio tone.
Haller et al. teaches a method for inserting an electrode array (paragraph 0020), providing feedback provided by using pitch or amplitude of the sound (paragraph 0057).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bendett et al. in combination by providing a visual indication or an audible indication of the position, as taught by Haller et al., to indicate to a user that an optimal position has been achieved, the audible indication of the position via a pitch of an audio tone, as taught by Haller et al. as is known in the art to provide specific feedback or indications with sound.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bendett et al. US 8,632,577 in view of Kuzma US 6968238 in view of Griffin, III et al. US 5888577 and in view of Ramos de Miguel, Sr. et al. US 2018/0140829, and further in view of Tortonese et al. US 9211403.
Regarding claim 29, Bendett et al. discloses a method essentially as claimed as discussed above, but fails to disclose wherein the guiding is performed at least in part by a robotic positioner.
Tortonese et al. teaches wherein the guiding is performed at least in part by a robotic positioner (figure 14, column 13, lines 1-13; system 1400 for automatic insertion of the electrode array, comprising an insertion tool 1430 supported by the articulated arm 1410 and base, or alternatively may be held manually by the surgeon), the system may operate by fully autonomous insertion or semi-autonomous insertion (column 12, lines 44-46).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bendett et al. with guiding being performed at least in part by a robotic positioner, as taught by Tortonese et al. to provide a system that may operate by fully autonomous insertion or semi-autonomous insertion.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bendett et al. US 8,632,577 in view of Kuzma US 6968238 in view of Griffin, III et al. US 5888577 in view of Tortonese et al. US 9211403 as discussed above, and further in view of Gibson et al. US 2006/0235500.
Regarding claim 31, Bendett et al. discloses a method essentially as claimed, but fails to
disclose transmitting light through the optical fiber bundle to illuminate an area at a distal end of the
vestibular electrode array to provide a visualization of a position of the vestibular electrode array; and
reflecting, via the optical fiber bundle, the visualization to an image sensor to monitor the position via
the optical fiber bundle.
Gibson et al. teaches transmitting light through the optical fiber bundle to illuminate an area at
a distal end of the vestibular electrode array to provide a visualization of a position of the vestibular
electrode array (paragraph 0023); and reflecting, via the optical fiber bundle, the visualization to an
image sensor to monitor the position via the optical fiber bundle (paragraph 0055-0057; light illuminates
adjacent the distal tip, eyepiece and/or camera receive light reflected from the object illuminated,
imaged detected by the camera lens during implantation and reduce trauma).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective
filing date of the invention to modify Bendett et al. with transmitting light through the optical fiber
bundle to illuminate an area at a distal end of the vestibular electrode array to provide a visualization of
a position of the vestibular electrode array, and reflecting, via the optical fiber bundle, the visualization
to an image sensor to monitor the position via the optical fiber bundle, as taught by Gibson et al. to
illuminate the and provide images of the surgical site during implantation to avoid and reduce trauma to
the cochlea walls.
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record or at large fails to disclose "using a stapes footplate of the recipient as a fulcrum to pivot a distal portion of the stylet about the stapes footplate and permit fine control of the distal portion of the stylet".
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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, Darwin Erezo can be reached at (571) 272-4695. 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.
/CHRISTINA C LAUER/Examiner, Art Unit 3771