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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/18/2024 n is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11, 14-16 and 25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 11, 14-16 and 25 all recite “the sensor unit”; however, no sensor unit is definitively claimed as part of the claimed invention. Claim 1 recites, “a control unit for controlling the vibration generator unit according to input from a user interface and/or input from a sensor unit for sensing the insertion of the electrode lead into the cochlea of the patient”. The limitations of claim 1 recite the sensor as an alternative input option, but does not definitively require the sensor since an alternative input option of a user interface may instead be provided. For the purposes of examination, the recitations of “the sensor unit” in claims 11, 14-16 and 25 are interpreted to recite “a sensor unit” until otherwise amended.
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, 10, 12-13, 18, 20-22 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahl (US 2021/0138236 A1) in view of Smith (US 2015/0119897 A1).
Regarding claim 1, Stahl discloses:
A system for inserting an electrode lead into a cochlea of a patient (see Fig. 13), comprising;
a vibration generator unit (vibrator 50, see Fig. 13) configured to be temporarily attached to the head of the patient (see Fig. 13 and Para. [0069]-[0070]) so as to transduce vibrations into the cochlea during an insertion procedure of the electrode lead into the cochlea for reducing friction of the electrode lead in the cochlea (see Para. [0069] and [0122]).
However, Stahl does not expressly disclose a control unit for controlling the vibration generator unit according to input from a user interface and/or input from a sensor unit for sensing the insertion of the electrode lead into the cochlea of the patient.
In the same field of endeavor, namely systems for inserting an electrode lead into a cochlea of a patient, Smith teaches a system for inserting an electrode into the cochlea of a patient (see Fig. 1A; see also Para. [0019] mentioning wherein the device of Fig. 1A is configured to delivery an implantable electrode assembly into the cochlea of a patient) comprising a vibration generator unit (vibration source 112, see Fig. 1A) and a control unit (controller 702, see Fig. 6B) configured to control the vibration generator unit according to input from a user interface and/or input from a sensor unit for sensing the insertion of the electrode lead into the cochlea of a patient (see Para. [0040]-[0041] mentioning wherein the controller receives input from a user interface 704 and stored vibration data characteristics to modify and manipulate the vibration produced by the vibration source 112).
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 device of Stahl to include a vibration generator unit controller as taught and suggested by Smith to, in this case, provide an interactable controller that allows a user to selectively control and modify the degree/amount of vibration imparted onto and within the ear canal by the vibrator (see Smith Para. [0040]-[0041]).
Regarding claim 10, the combination of Stahl and Smith disclose the invention of claim 1, Stahl, as modified by Smith, further disclose wherein the control unit is external to the vibration generator unit and wherein control und and the vibration generator unit are coupled via a wired or wireless communication interface (see Smith Para. [0040] mentioning wherein the controller 702, as incorporated into the device of Stahl, may be disposed external to the vibration source; due to the separation of the two components, a connection (i.e., either wired or wireless) would be inherent to functionally and operably connect the two components).
Regarding claim 12, the combination of Stahl and Smith disclose all of the limitations of the invention of claim 1.
However, the combination as currently presented does not expressly disclose wherein the control unit is configured to control the vibration generator unit based on predefined vibration profiles, each of which consists of a set of vibration parameters.
Smith further teaches wherein the vibration generator unit controller is configured to generate vibrations in accordance with a user-selected vibration profile (see Para. [0005]-[0006]) which help to maximize the effectiveness of the vibrations transferred to the ear canal which help to minimize insertion forces and as such reduce the risk of trauma (see Para. [0022] and [0037]).
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 vibration generator controller of Smith, as incorporated into the device of Stahl, to allow a user to select a desired pre-set vibration profile to be imparted to the ear canal as further taught and suggested by Smith to, in this case, help to maximize the effectiveness of the vibrations transferred to the ear canal which help to minimize insertion forces and as such reduce the risk of trauma (see Smith Para. [0022] and [0037]).
Regarding claim 13, the combination of Stahl and Smith disclose the invention of claim 12, Stahl, as modified by Smith, further discloses wherein the set of vibration parameters includes at least one of: amplitude, frequency spectrum, vibration orientation, duration, and variation of amplitude, frequency spectrum and/or vibration orientation as a function of time (see Smith Para. [0022] mentioning wherein the pre-set vibration profiles may include pre-set vibrational frequencies and amplitudes).
Regarding claim 20, the combination of Stahl and Smith disclose the invention of claim 1, Stahl, as modified by Smith, further discloses wherein the control unit is configured to control a direction of the vibrations generated by the vibration generator unit (see Stahl Para. [0011] mentioning wherein vibrations produced by the vibrator are imparted onto the temporal bone of a patient; any manipulation of the vibration parameters by the controller of Smith would thus be imparted onto the temporal bone since this is the only site to which vibrations are configured to be applied).
Regarding claim 21, the combination of Stahl and Smith disclose the invention of claim 1, Stahl, as modified by Smith, further disclose wherein the control unit is configured to control an application site of the vibrations generated by the vibration generator unit (see Stahl Para. [0011] mentioning wherein vibrations produced by the vibrator are imparted onto the temporal bone of a patient; since only one intended application site is disclosed, any manipulation of the vibration parameters by the controller of Smith would thus be imparted onto the temporal bone, thereby controlling the site during implantation of the lead to reduce frictional forces per Stahl Para. [0122]).
Regarding claim 22, the combination of Stahl and Smith disclose all of the limitations of the invention of claim 1.
However, Stahl does not expressly disclose an operating frequency range for the vibrator and thus does not expressly disclose wherein the vibration generator unit is configured to generate vibrations at frequencies within a range of up to 100kHz.
Smith further discloses wherein the vibration generator unit is configured to vibrate within a range of between 100 Hz and 200 Hz to perform the function of maximizing the effectiveness of the vibrations transferred by to the ear canal during insertion of an implantable lead so as to minimize the insertion force necessary, and therefore minimize any trauma experienced by the recipient (see Para. [0037]).
Since Stahl does not disclose an express frequency range for the vibrator to achieve the disclosed function of reducing friction during insertion of the implantable lead, one of ordinary skill in the art would have looked to the prior art for a teaching or disclosure of a known frequency range for accomplishing this function. It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the vibrator of Stahl to produce vibratory oscillations of within the frequency range of 100 Hz to 200 Hz as disclosed by Smith, since this frequency range is disclosed to be beneficial in maximizing the effectiveness of the vibrations transferred by to the ear canal during insertion of an implantable lead so as to minimize the insertion force necessary, and therefore minimize any trauma experienced by the recipient (see Smith Para. [0037]).
Regarding claim 27, Stahl discloses:
A method for inserting an electrode lead into a cochlea of a patient, comprising;
temporarily attaching a vibration generator unit (vibrator 50, see Fig. 13) to the head of the patient (see Fig. 13 and Para. [0069]-[0070]);
transducing vibrations from the vibration generator unit into the cochlea during an insertion procedure of the electrode lead into the cochlea for reducing friction of the electrode lead in the cochlea (see Para. [0069] and [0122]).
However, Stahl does not expressly disclose controlling, via a control unit, the vibration generator unit according to input from a user interface and/or input from a sensor unit for sensing the insertion of the electrode lead into the cochlea of the patient.
In the same field of endeavor, namely systems for inserting an electrode lead into a cochlea of a patient, Smith teaches a system for inserting an electrode into the cochlea of a patient (see Fig. 1A; see also Para. [0019] mentioning wherein the device of Fig. 1A is configured to delivery an implantable electrode assembly into the cochlea of a patient) comprising a vibration generator unit (vibration source 112, see Fig. 1A) and a control unit (controller 702, see Fig. 6B) configured to control the vibration generator unit according to input from a user interface and/or input from a sensor unit for sensing the insertion of the electrode lead into the cochlea of a patient (see Para. [0040]-[0041] mentioning wherein the controller receives input from a user interface 704 and stored vibration data characteristics to modify and manipulate the vibration produced by the vibration source 112).
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 device of Stahl to include a vibration generator unit controller as taught and suggested by Smith to, in this case, provide an interactable controller that allows a user to selectively control and modify the degree/amount of vibration imparted onto and within the ear canal by the vibrator (see Smith Para. [0040]-[0041]).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahl (US 2021/0138236 A1) in view of Smith (US 2015/0119897 A1), further in view of Ball (US 2004/0133250 A1).
Regarding claim 2, the combination of Stahl and Smith discloses all of the limitations of the invention of claim 1.
However, while Stahl discloses wherein the vibrator may be placed on the skull to apply mechanical vibration onto a temporal bone of a patient (see Para. [0011] and [0069]-0070]), Stahl does not expressly disclose wherein the vibration generator unit is configured to be temporarily attached the temporal bone or the forehead.
In the same field of endeavor, namely implantable cochlear devices comprising an implantable lead and vibration device, Ball teaches a system for inserting an electrode lead into a cochlea of a patient (see Figs. 2A-2C) comprising a vibration generator unit (transducer recited within Para. [0009]-[0012]) configured to be temporarily attached to the skull of a patient while generating vibrational oscillations within the ear canal (see Para. [0009]-[0012]); wherein the vibration generator unit is attached to a subject’s temporal bone (see Para. [0009]).
Since Stahl does not expressly disclose a precise cranial structure to which the vibrator is attached, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have looked to the prior art for common vibration generator unit placement locations for transmitting vibratory oscillations within an ear canal. Therefore, one of ordinary skill in the art would have found it obvious to have modified the vibrator of Stahl to be placed on a patient’s temporal bone, as disclosed by Ball, as a known location within the art for placing a vibration generator mechanism configured to generate vibrations within a patient’s ear canal.
Regarding claim 3, the combination of Stahl, Smith and Ball disclose the invention of claim 2, Stahl further discloses wherein the vibration generator unit is configured to be temporarily attached to the skull of the patient by screwing, clamping or gluing (see Para. [0070] mentioning wherein the vibrator may be attached to a patient’s skull either via a screw or by a softband which clamps and secures the vibrator to a patient’s skull).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahl (US 2021/0138236 A1) in view of Smith (US 2015/0119897 A1), further in view of Pawsey (US 2018/0050196 A1).
Regarding claim 4, the combination of Stahl and Smith discloses all of the limitations of the invention of claim 1.
However, while Stahl discloses wherein the vibrator may be placed on the skull, on the same side of the head as where the electrode array is to be inserted (see Para. [0069]-0070]), Stahl does not expressly disclose wherein the vibration generator unit is configured to be temporarily attached to the promontory of the patient.
In the same field of endeavor, namely implantable cochlear devices comprising an implantable lead and vibration device, Pawsey teaches a system for inserting an electrode lead into a cochlea of a patient (see Figs. 1 and 2) comprising a vibration generator unit (acoustic signal generator 704, see Fig. 7 and Para. [0094]) configured to be temporarily attached to the skull of a patient while generating vibrational oscillations within the ear canal (see Para. [0094]); wherein the vibration generator unit is attached to a subject’s promontory (see Para. [0094]).
Since Stahl does not expressly disclose a precise cranial structure to which the vibrator is attached, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have looked to the prior art for common vibration generator unit placement locations for transmitting vibratory oscillations within an ear canal. Therefore, one of ordinary skill in the art would have found it obvious to have modified the vibrator of Stahl to be placed on a patient’s promontory, as disclosed by Pawsey, as a known location within the art for placing a vibration generator unit configured to generate vibrations within a patient’s ear canal.
Regarding claim 5, the combination of Stahl, Smith and Pawsey disclose the invention of claim 4, Stahl, as modified by Pawsey, further discloses wherein the vibration generator unit is configured to be temporarily attached to the promontory of the patient by pressing, clamping or gluing (see Pawsey Para. [0094] mentioning wherein the acoustic signal generator 704 is temporarily attached to the promontory, as incorporated into the device configuration of Stahl, by pressing).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahl (US 2021/0138236 A1) in view of Smith (US 2015/0119897 A1), further in view of Bervoets (US 2024/0033507 A1), considered prior art because of a provisional patent application filed Jan. 4, 2021.
Regarding claim 6, the combination of Stahl and Smith disclose all of the limitations of the invention of claim 1.
However, Stahl does not expressly disclose wherein the system comprises a plurality of the vibration generator units.
In the same field of endeavor, namely electrical lead implantation devices, Bervoets teaches an electrical lead implantation device (see Figs. 1-2) comprising an implantable electrode (electrode assembly 118, see Figs. 1-2) and a vibration generator unit (transducer 206, see Fig. 2; see also Para. [0005] and [0037]-[0042]); wherein the vibration generator units are configured to impart and transmit vibrational energy to the ear canal and cochlea (see Para. [0005] and [0037]-[0042]); wherein a vibration generator units may be located on the temporal bone and/or promontory (see Para. [0042]; see also Para. [0070]-[0071] mentioning wherein different implementations/embodiments may be combined with one-another); wherein the vibration generator unit located on the promontory is configured to provide vibrations to stable bone structures of the auditory system on or close to the cochlea; and wherein the vibration generator unit located on the temporal bone is configured to transmit vibrations to the cochlea while circumventing the middle ear portion of the auditory system (see Para. [0042]).
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 device of Stahl to include an additional vibration generator unit located on the promontory (e.g., in addition to the vibrator located on the temporal bone shown in Stahl Fig. 13) as taught and suggested by Bervoets to, in this case, provide an additional vibrator configured to provide targeted vibrations to the inner ear near/at the cochlea, allowing a user to provide more targeted vibrations to the ear canal in the event that the implantable lead becomes stuck.
Regarding claim 7, the combination of Stahl, Smith and Bervoets disclose the invention of claim 6, Stahl, as modified by Bervoets, further discloses wherein each generator unit is configured to be temporarily attached at a different location of the head of the patient (vibrator of Stahl located on the exterior of a skull (see Fig. 13) in combination with the additional vibration generator unit of Bervoets located on the promontory).
Claim(s) 8-9, 11, 14 and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahl (US 2021/0138236 A1) in view of Smith (US 2015/0119897 A1), further in view of Huttenbrink (US 2012/0184804 A1).
Regarding claim 8, the combination of Stahl and Smith disclose all of the limitations of the invention of claim 1.
However, while Stahl discloses wherein the vibration generator unit is configured to transmit acoustic/vibration signals within a patient’s ear canal (see Para. [0122]), Stahl does not expressly disclose wherein the vibration generator unit comprises at least one vibration transducer.
In the same field of endeavor, namely systems for inserting implantable leads into a patient’s ear, Huttenbrink teaches a system for inserting implantable leads into a patient’s ear (see Figs. 1-2 and 8) comprising an implantable lead (electrode carrier 106, see Fig. 1) and an implant delivery device (insertion instrument 120, see Fig. 2; see also Para. [0032]) comprising a vibration generator unit (vibration generator 124, see Fig. 2) configured to produce vibrations during insertion which help to overcome friction effects and obstacles encountered when inserting the electrode carrier into the cochlea, reducing possible insertion trauma (see Para. [0030]), wherein the vibration generator unit may comprise either a floating mass transducer, an electromotor, a pneumatic actuator, a hydraulic actuator and/or a mechanical actuator (see Para. [0013 and] [0032]).
Since Stahl does not disclose an express type of vibrational transducer used within the vibrator, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have looked to the prior art for known transducer/actuator types to convert electrical energy to acoustic/vibrational energy to generate vibrations within an ear canal to aid in guiding an implantable lead therethrough. It would have therefore been obvious to one of ordinary skill in the art to have modified the vibrator of Stahl to utilize either a floating mass transducer, a pneumatic actuator, a hydraulic actuator and/or a mechanical actuator as disclosed to be known alternatives in the art by Huttenbrink to generate the disclosed vibrational oscillations within an ear canal (see Huttenbrink Para. [0013]).
Regarding claim 9, the combination of Stahl, Smith and Huttenbrink disclose the invention of claim 8, Stahl, as modified by Huttenbrink, further disclose wherein the vibration transducer comprises at least one of an electromotor, such as an electromotor linked to an unbalanced mass, a hydraulic actuator, a pneumatic actuator, a mechanical actuator, an electromagnetic actuator, a piezo actuator, and a sonic transducer (see Huttenbrink Para. [0013] mentioning wherein the vibration generator unit may include any of either a floating mass transducer, a pneumatic actuator, a hydraulic actuator and/or a mechanical actuator, as incorporated into the device of Stahl).
Regarding claim 11 (see 112(b) rejection above), the combination of Stahl and Smith disclose all of the limitations of the invention of claim 1.
However, Stahl does not expressly disclose wherein the control unit is configured to control the vibration generator unit based on predefined rules, taking into account the input from the sensor unit.
In the same field of endeavor, namely systems for inserting implantable leads into a patient’s ear, Huttenbrink teaches a system for inserting implantable leads into a patient’s ear (see Figs. 1-2 and 8) comprising an implantable lead (electrode carrier 106, see Fig. 1) and an implant delivery device (insertion instrument 120, see Fig. 2; see also Para. [0032]) comprising a vibration generator unit (vibration generator 124, see Fig. 2) configured to produce vibrations during insertion which help to overcome friction effects and obstacles encountered when inserting the electrode carrier into the cochlea, reducing possible insertion trauma (see Para. [0030]); wherein the housing of the delivery device may include a plurality of sensors at the distal end thereof configured to sense a force applied to the system (see Para. [0010], [0012] and [0029]); wherein the vibration generator unit is configured to control vibration parameters based on the sensed force (see Para. [0010], [0012] and [0029]) which gives a user greater ability to control various vibration parameters, allowing for a more controlled and safe use of the device (see Para. [0029]).
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 device of Stahl to include one or more force sensors along the length of the delivery device as taught and suggested by Huttenbrink to, in this case, sense and monitor the force being applied to the implant system during insertion into the ear canal to be utilized by the vibration generator unit controller to adjust and manipulate the vibrational forces applied within the ear canal, allowing for a greater degree of control and safety during use (see Huttenbrink Para. [0010], [0012] and [0029]).
Regarding claim 14 (see 112(b) rejection above), the combination of Stahl and Smith disclose all of the limitations of the invention of claim 12, Stahl, as modified by Smith, further discloses wherein the control unit is configured to automatically select, one pre-defined vibration profile from the plurality of predefined vibration profiles or blend, taking into account the input from the sensor unit, pre-defined vibration profiles from a plurality of predefined vibration profiles (see Smith Para. [0022], [0037] and [0042] mentioning wherein the vibration generator controller may automatically select a pre-defined vibration profile).
However, none of either Stahl or Smith expressly disclose wherein the vibration generator control unit takes into account inputs from a sensor unit in adjusting the vibrational profile.
In the same field of endeavor, namely systems for inserting implantable leads into a patient’s ear, Huttenbrink teaches a system for inserting implantable leads into a patient’s ear (see Figs. 1-2 and 8) comprising an implantable lead (electrode carrier 106, see Fig. 1) and an implant delivery device (insertion instrument 120, see Fig. 2; see also Para. [0032]) comprising a vibration generator unit (vibration generator 124, see Fig. 2) configured to produce vibrations during insertion which help to overcome friction effects and obstacles encountered when inserting the electrode carrier into the cochlea, reducing possible insertion trauma (see Para. [0030]); wherein the housing of the delivery device may include a plurality of sensors at the distal end thereof configured to sense a force applied to the system (see Para. [0010], [0012] and [0029]); wherein the vibration generator unit is configured to control vibration parameters based on the sensed force (see Para. [0010], [0012] and [0029]) which gives a user greater ability to control various vibration parameters, allowing for a more controlled and safe use of the device (see Para. [0029]).
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 combined device of Stahl and Smith to include one or more force sensors along the length of the device as taught and suggested by Huttenbrink to, in this case, sense and monitor the force being applied to the insertion/delivery system during insertion into the ear canal to be utilized by the vibration generator unit controller of Smith, as incorporated into the device of Stahl, to adjust and manipulate the vibrational forces applied within the ear canal, allowing for a greater degree of control and safety during use (see Huttenbrink Para. [0010], [0012] and [0029]).
Regarding claim 23, the combination of Stahl and Smith disclose all of the limitations of the invention of claim 1.
However, Stahl does not expressly disclose an amplitude of the vibrations generated by the vibrator to perform the function of reducing friction during insertion of the implantable lead and thus does not expressly disclose wherein the vibration generator unit is configured to generate vibrations with amplitudes within a range of up to 1 mm.
In the same field of endeavor, namely systems for inserting implantable leads into a patient’s ear, Huttenbrink teaches a system for inserting implantable leads into a patient’s ear (see Figs. 1-2 and 8) comprising an implantable lead (electrode carrier 106, see Fig. 1) and an implant delivery device (insertion instrument 120, see Fig. 2; see also Para. [0032]) comprising a vibration generator unit (vibration generator 124, see Fig. 2) configured to produce vibrations during insertion which help to overcome friction effects and obstacles encountered when inserting the electrode carrier into the cochlea, reducing possible insertion trauma (see Para. [0030]); wherein the amplitude of the vibrations are within a range of between 0mm and 5mm (see Para. [0031]).
Since Stahl does not expressly disclose an amplitude range for the vibrations generated by the vibrator to achieve the disclosed function of reducing friction during insertion of an implantable lead, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have looked to the prior art for known amplitude ranges that perform this function. It would have therefore been obvious to one of ordinary skill in the art to have modified the amplitude of the vibration wave produced by the vibrator of Stahl to be within a range of between 0mm and 1mm as applicant appears to have placed no criticality on the claimed range (see Specification Pg. 6, Lines 16-20 which provides no express critical function to the amplitude range claimed) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 24, the combination of Stahl and Smith disclose all of the limitations of the invention of claim 1.
However, none of either Stahl or Smith expressly disclose wherein the vibration generator unit is configured to generate vibrations in at least two orthogonal directions.
In the same field of endeavor, namely systems for inserting implantable leads into a patient’s ear, Huttenbrink teaches a system for inserting implantable leads into a patient’s ear (see Figs. 1-2 and 8) comprising an implantable lead (electrode carrier 106, see Fig. 1) and an implant delivery device (insertion instrument 120, see Fig. 2; see also Para. [0032]) comprising a vibration generator unit (vibration generator 124, see Fig. 2) configured to produce vibrations during insertion which help to overcome friction effects and obstacles encountered when inserting the electrode carrier into the cochlea, reducing possible insertion trauma (see Para. [0030]); wherein the vibrations generated by the vibration generator unit may be longitudinal, transverse and/or rotational (see Para. [0010] and [0031]).
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 vibrator of Stahl to be configured to generate vibratory oscillations along both the longitudinal and transverse axes of the implantable lead device as disclosed by Huttenbrink to, in this case, provide for an increased range of available vibration oscillation pattens which would provide more variability in the vibrations produced, resulting in an increased effectiveness in reducing friction based on the orientation of the implantable lead within the ear canal.
Regarding claim 25, the combination of Stahl and Smith disclose all of the limitations of the invention of claim 1.
However, Stahl does not expressly disclose a sensor and thus does not expressly disclose wherein the input from the sensor unit includes at least one of cochlea microphonic signals, impedances measured by the electrodes of the electrode lead, signals of an optical sensor integrated in the electrode lead, signals of an acoustic sensor integrated in the electrode lead, signals of a force sensor integrated in the electrode lead, signals of a strain sensor integrated in the electrode lead and signals from an insertion depth sensor.
In the same field of endeavor, namely systems for inserting implantable leads into a patient’s ear, Huttenbrink teaches a system for inserting implantable leads into a patient’s ear (see Figs. 1-2 and 8) comprising an implantable lead (electrode carrier 106, see Fig. 1) and an implant delivery device (insertion instrument 120, see Fig. 2; see also Para. [0032]) comprising a vibration generator unit (vibration generator 124, see Fig. 2) configured to produce vibrations during insertion which help to overcome friction effects and obstacles encountered when inserting the electrode carrier into the cochlea, reducing possible insertion trauma (see Para. [0030]); wherein the housing of the delivery device may include a plurality of force sensors at the distal end thereof configured to sense a force applied to the system (see Para. [0010], [0012] and [0029]); wherein the vibration generator unit is configured to control vibration parameters based on the sensed force (see Para. [0010], [0012] and [0029]) which gives a user greater ability to control various vibration parameters, allowing for a more controlled and safe use of the device (see Para. [0029]).
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 combined device of Stahl and Smith to include one or more force sensors along the length of the device as taught and suggested by Huttenbrink to, in this case, sense and monitor the force being applied to the insertion/delivery system during insertion into the ear canal to be utilized by the vibration generator unit controller of Smith, as incorporated into the device of Stahl, to adjust and manipulate the vibrational forces applied within the ear canal, allowing for a greater degree of control and safety during use (see Huttenbrink Para. [0010], [0012] and [0029]).
Claim(s) 15-17 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahl (US 2021/0138236 A1) in view of Smith (US 2015/0119897 A1), further in view of Avci (US 2022/0367028 A1).
Regarding claim 15 (see 112(b) rejection above), the combination of Stahl and Smith disclose all of the limitations of the invention of claim 1.
However, none of either Stahl or Smith expressly disclose wherein the control unit is configured to apply a machine learning procedure for periodical classification of the present electrode lead insertion situation based on the input from the sensor unit.
In the same field of endeavor, namely systems for inserting implantable leads into a cochlea, Avci teaches a system for inserting implantable leads into a cochlea (see Fig. 1) comprising an implantable lead (implant 102, see Fig. 1) and a control unit (processing unit 108, see Fig. 1); wherein the control unit is configured to apply a machine learning procedure for periodical classification of the present electrode lead insertion situation based on the input from the sensor unit (see Para. [0017]-[0018], [0056], [0069]-[0070] and [0075]-[0081] mentioning wherein a machine learning model 502 (see Fig. 5) may be incorporated into the insertion system to provide assistance for inserting an electrode lead into a the cochlea of a recipient; wherein the machine learning model receives inputs of geometric data, contextual attributes of a lead insertion procedure, and intraoperative measurements in which data from one or more force/pressure sensors feed real-time data of the forces applied during the insertion procedure to the machine learning model to allow for tracking and monitoring of the insertion procedure. This data may be used in, as an example, detection if the implantable lead is pressing against the wall of the cochlea; wherein the input force/pressure data is used by the machine learning model to make adjustments in real-time to the insertion procedure to ensure alignment of predictive parameters with intraoperative parameters (i.e., adjustment of insertion angle, speed, depth, etc.)).
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 device of Stahl to incorporate a plurality of force/pressure sensors therein to be used to send data/feedback of the forces/pressures applied to the system during insertion of the lead into the ear canal to a machine learning model, in functional communication with the vibration generator unit controller, as taught and suggested by Avci to, in this case, provide the machine learning model with real-time force/pressure data from the lead insertion/implantation procedure to allow the machine learning model to adapt and adjust, via engagement with the vibration generator unit controller, various parameters of the insertion/implantation procedure in real time based on the received input data, ensuring intraoperative measurements align with predicted parameters (i.e., adjustment of insertion angle, speed, depth, etc.) (see Avci Para. [0017]-[0018], [0056], [0069]-[0070] and [0075]-[0081]).
Regarding claim 16 (see 112(b) rejection above), the combination of Stahl and Smith disclose all of the limitations of the invention of claim 1.
However, none of either Stahl or Smith expressly disclose wherein the control unit is configured to continuously adapt vibration parameters according to a machine learning procedure based on the input from the sensor unit.
In the same field of endeavor, namely systems for inserting implantable leads into a cochlea, Avci teaches a system for inserting implantable leads into a cochlea (see Fig. 1) comprising an implantable lead (implant 102, see Fig. 1) and a control unit (processing unit 108, see Fig. 1); wherein the control unit is configured to apply a machine learning procedure for periodical classification of the present electrode lead insertion situation based on the input from the sensor unit (see Para. [0017]-[0018], [0056], [0069]-[0070] and [0075]-[0081] mentioning wherein a machine learning model 502 (see Fig. 5) may be incorporated into the insertion system to provide assistance for inserting an electrode lead into a the cochlea of a recipient; wherein the machine learning model receives inputs of geometric data, contextual attributes of a lead insertion procedure, and intraoperative measurements in which data from one or more force/pressure sensors feed real-time data of the forces applied during the insertion procedure to the machine learning model to allow for tracking and monitoring of the insertion procedure. This data may be used in, as an example, detection if the implantable lead is pressing against the wall of the cochlea; wherein the input force/pressure data is used by the machine learning model to make adjustments in real-time to the insertion procedure to ensure alignment of predictive parameters with intraoperative parameters (i.e., adjustment of insertion angle, speed, depth, etc.)).
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 device of Stahl to incorporate a plurality of force/pressure sensors therein to be used to send data/feedback of the forces/pressures applied to the system during insertion of the lead into the ear canal to a machine learning model, in functional communication with the vibration generator unit controller, as taught and suggested by Avci to, in this case, provide the machine learning model with real-time force/pressure data from the lead insertion/implantation procedure to allow the machine learning model to adapt and adjust, via engagement with the vibration generator unit controller, various parameters of the insertion/implantation procedure in real time based on the received input data, ensuring intraoperative measurements align with predicted parameters (i.e., adjustment of insertion angle, speed, depth, etc.) (see Avci Para. [0017]-[0018], [0056], [0069]-[0070] and [0075]-[0081]).
Regarding claim 17, the combination of Stahl, Smith and Avci disclose the invention of claim 16, Stahl, as modified by Avci, further discloses wherein the machine learning procedure is implemented as a pre-trained artificial neural network (see Avci Para. [0053]-[0054] mentioning wherein the pre-trained machine learning model is implemented as an artificial neural network).
Regarding claim 26, the combination of Stahl and Smith disclose all of the limitations of the invention of claim 1.
However, Stahl does not expressly disclose wherein the control unit is configured to use a predicted virtual cochlea model for controlling the vibrator generator unit obtained from pre-operative images of the cochlea.
In the same field of endeavor, namely systems for inserting implantable leads into a cochlea, Avci teaches a system for inserting implantable leads into a cochlea (see Fig. 1) comprising an implantable lead (implant 102, see Fig. 1) and a control unit (processing unit 108, see Fig. 1); wherein the processor (i.e., computing device) is configured to generate a geometric model based on one or more preoperative images of a recipient’s cochlea to be transmitted to a display and used/interacted with by a user before and during a lead insertion procedure (see Para. [0060]).
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 vibration generator unit controller of Smith, as incorporated into the device of Stahl, to be configured to generate a virtual geometric model of a patient’s cochlea from preoperative images to be utilized during a lead insertion procedure to be output to a display to allow a user to interact with and modify the insertion procedure based on the generated real-time display (see Avci Para. [0060]).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahl (US 2021/0138236 A1) in view of Smith (US 2015/0119897 A1), further in view of Schepis (US 2022/0096822 A1).
Regarding claim 19, the combination of Stahl and Smith disclose all of the limitations of the invention of claim 1, Stahl, as modified by Smith, further discloses wherein the control unit is configured to control the spectral composition of the vibrations generated by the vibration generator unit, in particular, an amplitude as a function of frequency, and a frequency modulation (see Para. [0022] mentioning wherein the vibration generator unit controller of Smith, as incorporated into the device of Stahl, is configured to control an amplitude and frequency of the vibration generator unit).
However, Smith does not expressly disclose wherein the control unit is configured to control a center frequency and a bandwidth.
In the same field of endeavor, namely control systems for manipulating and controlling noise signal generators, Schepis teaches a control system within an implantable lead delivery device (see Fig. 1) comprising an implantable lead (lead 108, see Fig. 1), a noise/vibration generator unit (noise generator 109, see Fig. 1) and a controller therefore (controller 110, see Fig. 1); wherein the controller is configured to control various aspects of the noise/vibration generator including, for example, center frequency, bandwidth and/or power (see Para. [0124]).
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 vibration generator unit controller of Smith, as incorporated into the device of Stahl, to be configured to and capable of modifying the center frequency and bandwidth of vibrations produced by the vibrator as disclosed by Schepis to, in this case, provide increased control over the vibrations produced within the insertion system to ensure more efficient and optimized insertion of the implantable lead device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically US 2016/0037273 A1 to Gustafsson, US 2010/0114288 A1 to Haller, US 2007/0225787 A1 to Simaan all disclose lead delivery systems comprising an insertion system and vibration producing mechanism. Additionally, US 20220160995 A1 to Wetmore, US 20260046572 A1 to Rambault and US 20180264266 A1 to Owen disclose cochlear electrode devices comprising one or more transducers located at different locations along the head/ear canal.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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