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 .
Drawings
The drawings are objected to because Figures 1-3 use shading, however, this shading reduces legibility. See CFR 1.84(m) which states “Shading. The use of shading in views is encouraged if it aids in understanding the invention and if it does not reduce legibility. Shading is used to indicate the surface or shape of spherical, cylindrical, and conical elements of an object. Flat parts may also be lightly shaded. Such shading is preferred in the case of parts shown in perspective, but not for cross sections. See paragraph (h)(3) of this section. Spaced lines for shading are preferred. These lines must be thin, as few in number as practicable, and they must contrast with the rest of the drawings. As a substitute for shading, heavy lines on the shade side of objects can be used except where they superimpose on each other or obscure reference characters. Light should come from the upper left corner at an angle of 45°. Surface delineations should preferably be shown by proper shading. Solid black shading areas are not permitted, except when used to represent bar graphs or color”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Response to Amendment
In response to the amendment filed on 11/12/2025, Claims 1-14 have been cancelled, and Claims 15-27 are pending.
Amended claim 27 to rectify USC 112 issues has been acknowledged and the rejection has been withdrawn.
Response to Arguments
Applicant’s arguments, see pg. 6-7, filed 11/12/2025, with respect to USC 101 rejection of claim 15 has been fully considered and are persuasive. The rejection of claim 15 has been withdrawn.
Applicant’s arguments, see pg. 7-8, filed 11/12/2025, with respect to the rejection of claim 15 under USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of applicant’s amendments.
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.
Claims 15-17 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over US 20070225787 A1 Simaan et al. (hereinafter Simaan) in view of US 20100114288 A1 Haller et al. (hereinafter Haller).
Regarding claim 15, Simaan discloses a system for automated insertion of a cochlear implant electrode (Fig. 1, 4a, 6, paragraph 23, 46) comprising an insertion tool 410 and insertion progress monitoring equipment (monitor 420 and force feedback and location measurements from input module 410) that is configured to insert a cochlear implant electrode (Fig. 4a, 6, paragraph 35-36, 39, 46-52), wherein the system is configured to: determine a desired insertion state and desired insertion progress plan for the cochlear implant electrode (paragraph 36, 45-46, 61-62); monitor insertion progress through available patient, cochlear implant electrode and instrument data (Fig. 5a-5d, 6 step 604, paragraph 36, 39, 47-52, 55) ; and confirm that the cochlear implant electrode has reached the desired insertion state (Fig. 6 step 608, paragraph 36, 46, 55).
Simaan is silent on wherein the system comprises a feedback loop where insertion trajectory, speed, and orientation can be altered by the system without user input to align insertion progress with the insertion progress plan.
However, Haller teaches an automated system for inserting a cochlear implant (abstract, paragraph 47) wherein the system comprises a feedback loop where insertion trajectory, speed, and orientation can be altered by the system without user input to align insertion progress with an insertion progress plan (paragraph 55, “The automated insertion tool (600) is attached to a controller (700)…the controller (700) could use a variety of algorithms that analyze previous surgical data. By way of example and not limitation, these algorithms could include genetic algorithm, or other learning techniques to assist in providing optimal insertion trajectories based on previous insertion data”; paragraph 74, “When the third force curve (860) makes an unexpected deviation from the average force profile of past surgeries, as shown by the circled area (870), the automated insertion tool may take proactive steps to prevent the applied force from approaching the maximum allowable force profile (810). For example, the automated insertion tool may determine from the data represented by the actual force curve (860) that there is a substantial likelihood that, if the insertion is continued, the maximum applied force profile will be reached. The automated insertion tool can then make adjustments to reduce the amount of applied force required to continue the insertion. For example, the automated insertion tool may adjust the insertion angle or rotate the electrode”; paragraph 79-81, “The operation then begins with the cochlear lead being inserted into the opening and the real time force and position feedback being received by the automated insertion device (step 930). As the insertion proceeds, there is a real time evaluation of the feedback to determine if there is a substantial deviation from the operating parameters (determination 940)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Simaan with the teachings of Haller to have wherein the system comprises a feedback loop where insertion trajectory, speed, and orientation can be altered by the system without user input to align insertion progress with the insertion progress plan, in order to provide optimal insertion trajectories and take proactive steps to make adjustments to continue insertion and optimal electrode placement as disclosed by Haller (paragraph 55, 74-75).
Regarding claim 16, the combination of Simaan and Haller teaches the limitations of claim 15, and Haller further discloses wherein determining the desired insertion state and desired insertion progress plan is based upon population specific data, patient specific data and cochlear implant electrode specific data (paragraph 55, 74-75, 77) and wherein desired insertion progress may be expressed in terms of any of insertion depth, speed, direction, orientation, speed profile and orientation profile (paragraph 55, 74-75, 77) and wherein the desired insertion state may be expressed in terms of any of cochlear implant electrode entry position, cochlear implant electrode orientation, cochlear implant electrode bending, cochlear implant electrode shape, and number of electrode portions inside the cochlea (paragraph 55, 74-75, 77).
Regarding claim 17, the combination of Simaan and Haller teaches the limitations of claim 16, and Haller further discloses wherein population specific data may include anatomical atlas data, statistical cochlear shape data, and genetic data (paragraph 55), and wherein patient specific data may include a given patient's medical image data, audiological data, electrophysiological data and genetic data (paragraph 66), and wherein cochlear implant electrode specific data may include a given cochlear implant electrode's physical dimensions, material properties, electrical properties, chemical properties and tribology profile (paragraph 77).
Regarding claim 23, the combination of Simaan and Haller teaches the limitations of claim 15, and Simaan further discloses wherein confirming that the cochlear implant electrode has reached the desired insertion state includes comparing monitored insertion progress data to the desired insertion state (Fig. 6, paragraph 36, 46, 55).
Regarding claim 24, the combination of Simaan and Haller teaches the limitations of claim 23, and Simaan further discloses wherein confirming that the cochlear implant electrode has reached the desired insertion state may be achieved through the use of any of instrument or insertion tool kinematic data (Fig. 5d, paragraph 51-52, 66-67), stereotactic tracking of the cochlear implant electrode or an instrument (paragraph 36, 60), measuring insertion force (Fig. 5a-c, Fig. 6 step 604, paragraph 36, 47-50), and visualizing or deriving shape of the cochlear implant electrode (paragraph 58, 61).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Simaan in view of Haller as applied to claim 17 above, and further in view of US 20150119966 A1 Richter et al. (hereinafter Richter).
Regarding claim 18, the combination of Simaan and Haller teaches the limitations of claim 17.
The combination is silent on wherein determining desired insertion states and insertion progress plans includes a preferred cochlear implant electrode choice determined by selecting different cochlear implant electrodes in a sequential manner and in which a computer-generated score is computed for each cochlear implant electrode choice and in which the cochlear implant electrode with the highest score most likely provides an optimal insertion state and insertion progress plan for the given patient.
However, Richter teaches an automated system for assigning scores to a surgical implant and the planning of the surgical implant (paragraph 7-8, 34, 36-39, 54-56), the scores assigned allow a physician to choose an implant and planning path that is likely to produce a successful surgical outcome (paragraph 38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Simaan with Haller with the teachings of Richter to have wherein determining desired insertion states and insertion progress plans includes a preferred cochlear implant electrode choice determined by selecting different cochlear implant electrodes in a sequential manner and in which a computer-generated score is computed for each cochlear implant electrode choice and in which the cochlear implant electrode with the highest score most likely provides an optimal insertion state and insertion progress plan for the given patient, in order to allow a physician to choose an implant and planning path that is likely to produce a successful surgical outcome as disclosed by Richter (paragraph 38).
Regarding claim 19, the combination of Simaan, Haller and Richter teaches the limitations of claim 18, and the combination further teaches wherein an ultimate selection of the cochlear implant electrode may be an automated, iterative process using the score computed for each implant choice (Richter: paragraph 36, 61-62), and employing a computerized planning tool incorporating a database of patient and cochlear implant electrode data (Richter: paragraph 27).
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Simaan in view of Haller as applied to claim 15 above, and further in view of US 20180050196 A1 Pawsey et al. (hereinafter Pawsey).
Regarding claim 20, the combination of Simaan and Haller teaches the limitations of claim 15, and Simaan further discloses wherein monitoring insertion progress is performed using instrument or insertion tool kinematic data (Fig. 5d, paragraph 51-52, 66-67, monitoring insertion speed), stereotactic tracking of the cochlear implant electrode by tracking the cochlear implant electrode or an instrument or insertion tool (paragraph 36, 60, tracking motions of markers along electrode array), measuring insertion force as a function of position (Fig. 5a-c, Fig. 6 step 604, paragraph 36, 47-50), and monitoring shape of the cochlear implant electrode (paragraph 58, 61).
The combination is silent on wherein monitoring insertion progress is performed using intraoperative imaging, electrocochleography, and tissue impedance measurements.
However, Pawsey teaches a robotic system for insertion of a cochlear implant (paragraph 7-10), wherein monitoring insertion progress is performed using intraoperative imaging (paragraph 248-249, Sensing unit 432 is configured to scan the head of a recipient and obtain data indicative of spatial locations of internal organs (e.g., mastoid bone 221, middle ear cavity 423 and/or ossicles 106, etc.) In an exemplary embodiment, sensing unit 432 is a unit that is also configured to obtain data indicative of spatial locations of at least some components of the insertion guide and/or other components of the robotic apparatus attached thereto…sensing unit 432 is an MRI system, an X-Ray system, an ultrasound system, a CAT scan system), electrocochleography (paragraph 133, 135-136), and tissue impedance measurements (paragraph 318).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Simaan with Haller with the teachings of Pawsey to achieve wherein monitoring insertion progress is performed using intraoperative imaging, electrocochleography, and tissue impedance measurements in order to more accurately monitor the insertion of the cochlear implant to prevent unnecessary injury to the patient and to facilitate placing the implant in the desired location.
Regarding claim 21, the combination of Simaan, Haller and Pawsey teaches the limitations of claim 20, and Simaan further teaches wherein monitoring the shape of the cochlear implant electrode may be performed by intraoperative imaging or by deriving shape from available position and force data (paragraph 58, 61-67).
Regarding claim 22, the combination of Simaan, Haller and Pawsey teaches the limitations of claim 20, and Simaan further teaches the system comprising comparing monitored insertion progress data to the desired insertion progress state and desired insertion progress plan to assess whether the desired insertion state may have been reached (Fig. 6, paragraph 36, 46, 55).
Claims 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Simaan in view of Haller as applied to claim 15 above, and further in view of US 20130131486 A1 Copf et al. (hereinafter Copf).
Regarding claim 25, the combination of Simaan and Haller teaches the limitations of claim 15, and Simaan further discloses a computerized planning tool capable of collecting insertion progress data and comparing the insertion progress data to a preoperative plan (paragraph 54-55).
The combination is silent on the computerized planning tool incorporating a database of patient and cochlear implant electrode data.
However, Copf teaches a computerized planning tool (paragraph 152) that incorporates a database of patient and implant data (paragraph 26-27, paragraph 64, 66, 152).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Simaan with Haller with the teachings of Copf in order to achieve a computerized planning tool incorporating a database of patient and cochlear implant electrode data in order to improve the accuracy of planning produced by the computer program as disclosed by Copf (paragraph 27).
Regarding claim 26, the combination of Simaan, Haller and Copf teaches the limitations of claim 25, and Simaan further discloses wherein the insertion tool is a teleoperated device that is capable of carrying out kinematic movements with at least three degrees of freedom (paragraph 35, 39, 61).
Regarding claim 27, the combination of Simaan, Haller and Copf teaches the limitations of claim 26, and Simaan further discloses wherein the teleoperated device comprises a computer that is configured to receive insertion progress data, adjust insertion parameters on the basis of received insertion progress data and determine when an insertion end state has been reached (paragraph 54-55).
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 KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KHOA TAN LE/ Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771