DETAILED ACTION
This action is pursuant to the claims filed on 06/15/2026. Claims 1-22 are pending. A first action on the merits of claims 1-22 is as follows.
Response to Amendment
Applicant’s amendment to the claims are acknowledged and entered accordingly.
Claim Objections
Claim 21 is/are objected to because of the following informalities:
Claim 21 should be dependent upon claim 20 based on the recitation of “the robotically-assisted surgical system” in claim 21.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 6-8, 11-14, 16-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tortonese (WO 2011/053766).
Regarding claim 1, Tortonese teaches A device comprising: an electrode array (Fig 4A electrode array 195); and a thin-film sensing array comprising one or more sensing elements (Fig 8a and [0059], silicone strain gage 800 with contact pads 805-1 to 805-3), integrated with the electrode array ([0059] silicon strain gage 800 incorporated along steerable stylet 400); and an electrical connection coupled to the sensing array for receiving sensing information from the sensing array (Fig 9 and [0062] disclosing electrical connection of strain gage 800 to steerable stylet 400).
Regarding claim 2, Tortonese teaches wherein the electrode array is a component of a cochlear implant (see Fig 1) and further wherein the electrode array comprises a plurality of electrodes embedded in a substrate (Fig 4A, electrodes 465 in flexible body 475).
Regarding claim 3, Tortonese teaches wherein the plurality of sensing elements are optical or electrical (Fig 8A, strain gage 800 is an electrical element).
Regarding claim 6, Tortonese teaches wherein the one or more sensing elements include strain sensors (Fig 8a strain gage 800).
Regarding claim 7, Tortonese teaches wherein the strain sensors comprise a plurality of interdigitated fingers (Fig 8a, contact pads 805-1, 805-2, 805-3 are interdigitated fingers).
Regarding claim 8, Tortonese teaches wherein each interdigitated finger comprises a stack consisting of a polymer supporting a thin-film conductive layer (Fig 8a-b, stack with silicon substrate 835 supporting thin film conductive layers).
Regarding claim 11, Tortonese teaches wherein the thin-film sensing array is adhered to the electrode array using an adhesive material ([0062] disclosing use of adhesives to secure materials of device).
Regarding claim 12, Tortonese teaches wherein the thin-film sensing array is integrated with the electrode array during a manufacturing process of the electrode array (Figs 4a, 8a, 9, [0059] silicon strain gage 800 is incorporated along steerable stylet 400 strain gage 800 during manufacturing process).
Regarding claim 13, Tortonese teaches A system comprising: an instrumented electrode array (Fig 4A electrode array 195); a readout system, electrically coupled to the electrode array; and a user interface in communication with the readout system ([0076] disclosing actuators and control system to provide functions such as visual or audio output, calibrations, or other functions for semi-autonomous insertion; Fig 15 shows display 1500 during insertion).
Regarding claim 14, Tortonese teaches wherein the electrode array is a component of a cochlear implant comprising a plurality of electrodes embedded in a substrate (Fig 1 and Fig 4A, electrodes 465 in flexible body 475).
Regarding claim 16, Tortonese teaches wherein the readout system comprises: a microcontroller to process and store the data collected from the sensing array; and circuitry required to operate the sensing array ([0076] disclosing controller 1320 and sensor support module; controllers known to store data).
Regarding claim 17, Tortonese teaches wherein the circuitry comprises: one or more of resistive, capacitive, or impedance measurement circuits ([0065] disclosing strain gages require the measurement of resistance); and voltage or current sources for powering the sensing elements (controller and corresponding circuitry necessarily has voltage and current sources for powering the device to function).
Regarding claim 18, Tortonese wherein the user interface comprises: means for providing audible, tactile, or visual feedback to the user regarding positioning of the electrode array during insertion into a cochlea ([0076] disclosing visual or audio feedback; Fig 15 shows display during insertion).
Regarding claim 19, Tortonese further wherein the visual feedback includes a visualization comprising a 3D pose of the electrode array and/or the strain or force distribution along the electrode array (Fig 15 showing force distribution; [0082] disclosing Fig 15 as part of visualization of display 1500).
Regarding claim 20, Tortonese wherein the system is integrated into a robotically-assisted surgical system (see Fig 14).
Regarding claim 21, Tortonese wherein the robotically-assisted surgical system obtains information regarding the electrode array from the electrodes in the electrode array and further wherein the robotically-assisted surgical system uses both the information from the electrodes and information from the sensing array to provide feedback to the user (Fig 14, flowchart of Fig 16 disclosing use of robotic system to use feedback loops from sensor and electrode arrays).
Claim(s) 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walraevens (U.S. PGPub No. 2015/0126900).
Regarding claim 22, Walraevens teaches A device, comprising: an electrode array (Figs 3A-B, electrode array 146 with electrodes 148); and a thin-film sensing array comprising one or more sensing elements (Fig 4A, diaphragms 334 define thin film sensing elements that detect pressure and/or vibration as disclosed in at least [0049], [0064]), wherein the thin-film sensing array is integrated with the electrode array such that the thin-film sensing array remains attached to the electrode array after implantation of the electrode array (Fig 3B and [0045] sensor assembly 350 remains electrically and physically attached to electrode array 148 after implantation); and an electrical connection coupled to the sensing array for receiving sensing information from the sensing array (Fig 5 electrical leads 355 and other electronics for receiving information from receptor 330).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tortonese.
Regarding claims 5 and 15, Tortonese teaches wherein the sensing array comprises sensors of different sensing modalities (Fig 8-10 show strain gage sensing modalities, Fig 11 shows optical sensing modality, Fig 12 discloses pressure sensor; Fig 15-16 discloses force sensors; [0059] disclosing each sensor can be incorporated in the steerable stylet). Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the system of Tortonese to incorporate sensors of different sensing modalities within the thin-film sensing array in order to provide various sensors within the steerable stylet of the cochlear implant as taught by Tortonese to arrive at claims 5 and 15 respectively. Doing so would be obvious to one of ordinary skill in the art as the use of different sensing modalities is well-known in the art to yield predictable results as disclosed by Tortonese ([0059]).
Claim(s) 4 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tortonese in view of Paz (WO 2020/035852).
Regarding claim 4, Tortonese discloses the device of claim 3.
Tortonese fails to teach the sensing array further comprises one or more electrochemical or microfluidic systems integrated into the sensing array.
In related prior art, Paz discloses wherein the sensing array further comprises one or more electrochemical or microfluidic systems integrated into the sensing array (Page 77 lns 19-30). Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Tortonese in view of Paz to provide the electrochemical or microfluidic systems integrated into the sensing array, as taught by Paz, to arrive at claim 4. Doing so would advantageously provide the ability of the array to sense chemical compounds (Page 77, lns 19-30).
Regarding claim 9, Tortonese teaches the device of claim 8 as stated above.
Tortonese fails to explicitly teach wherein each strain sensor further comprises: a first trace electrically-coupled to a first sub-plurality of the fingers; and a second trace electrically-coupled to a second sub-plurality of the fingers; wherein the first and second sub-pluralities are exclusive of each other.
In related prior art, Paz discloses wherein each strain sensor further comprises: a first trace electrically-coupled to a first sub-plurality of the fingers (the integrated circuit includes a patterned diffusion of trace elements including a first trace electrically couple to the substrate of semiconductor silicone material and includes application specific integrated circuits such as the force sensor; page 139, lines 28-34); and a second trace electrically-coupled to a second sub-plurality of the fingers (the integrated circuit includes a patterned diffusion of trace elements including a second trace electrically couple to the substrate of semiconductor silicone material and includes application specific integrated circuits such as the force sensor; page 139, lines 28-34); wherein the first and second sub-pluralities are exclusive of each other (wherein the first and second patterned diffusions of trace elements are related to their own respective integrated circuit element which are exclusive of one another; page 139, lines 28-34). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Tortonese in view of Paz to provide wherein each strain sensor further comprises: a first trace electrically-coupled to a first sub-plurality of the fingers; and a second trace electrically-coupled to a second sub-plurality of the fingers; wherein the first and second sub-pluralities are exclusive of each other, as taught by PAZ, to arrive at claim 9. Doing so would advantageously provide a plurality of integrated circuit components and sensors to yield predictable results therein (page 139, lines 28-34).
Regarding claim 10, in view of the combination of claim 9 above, Tortonese teaches wherein the first and second traces are electrically coupled to the electrical connection (Figs 8a-9, traces are connected to electrical connection of device).
Response to Arguments
Applicant's arguments filed 06/15/2026 have been fully considered but they are not persuasive.
Applicant’s arguments to claim 1 allege that Tortonese fails to teach the thin film sensing array “integrated with the electrode array” on the basis that the thin-film sensing array of Tortonoese is removable from the electrode array. This argument is unpersuasive. The mere fact that the steerable stylet and thin-film sensing array is removable does not preclude the thin-film sensing array from being integrated with the electrode array. The Oxford Learner’s Dictionary definition for integrated reads “in which many different parts are closely connected and work successfully together”. In the instant case, during insertion of the cochlear implant of Tortonose, the thin-film sensing array of the steerable stylet 400 is integrated (i.e., many different parts are closely connected and work successfully together) with the electrode array 195 as shown in at least Figures 4A and 5A.
Regarding claim 13, the applicant alleges that Tortonese fails to teach an “instrumented” electrode array. The electrode array 195 of Tortonose is clearly and explicitly “instrumented” in that the electrode array 195 functions to provide electrical stimulation to the auditory nerve as disclosed in [0031]. These arguments are unpersuasive.
Arguments directed to claims 5, 15, and 4 and 9-10 are unpersuasive for the reasons stated above.
Conclusion
THIS ACTION IS MADE FINAL. 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 Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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