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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/19/2026 has been entered.
Response to Arguments
Applicant’s arguments filed 1/19/2026 have been fully considered but are not persuasive.
Applicant argues, “…claim 1 has been amended to recite "the determining that the second electrode has not yet been inserted into the cochlea comprising determining, based on the voltage detected between the second electrode and the ground contact, that the second electrode does not detect the electrical pulse" (emphasis added). Kabot does not disclose such a determination, nor could it be obvious given the teachings of Kabot to make such a determination. This is at least in part because Kabot only discloses impedance/conductivity measurements in which a same first electrode contact is used for both stimulating and measuring voltage or current and a second contact is used for a ground reference. In contrast, by using a first electrode to generate an electrical pulse and then measuring a voltage between a second electrode and a ground electrode, the inventive system can determine whether the second electrode detected the electrical pulse (i.e., whether there was current spread to the second electrode resulting from the electrical pulse). See, e.g., paragraph 0057 of Applicant's specification.). Kabot does not disclose any such measurement.”
Examiner respectfully disagrees. Kabot teaches that impedance measurements [0027] are made by supplying stimulation to an electrode contact [0027], and teaches measuring conductivity associated with an electrode to determine insertion status (fig. 2; [0025]).
Kabot further teaches that electrodes are to be inserted into cochlear ducts [0025], which are filed with perilymph [0025], a fluid known to have high conductivity [0025]. However, the middle ear [0025], where insertion is carried out [0025], is instead filled with air [0025], which is known to have zero or low conductivity [0025].
Therefore, Examiner asserts that the second electrode being inserted in the middle ear instead of the cochlear ducts would result in low or zero conductivity, which is being interpreted as the electrical pulse not being detected, because there would be no electrical path made with air for the second electrode to detect the electrical pulse. Further, Kabot teaches that measuring conductivity is associated with impedance values [0026-0027], which would be substituted with voltage, as yielded by the proposed combination.
Similarly, Applicant’s specifications disclose a conduction path [0055] being provided when electrodes [0055] are within a cochlea [0055] due to fluid being present [0055], as opposed to air being present in a middle ear [0055], which does not effectively conduct current [0056] and thus prevents the conduction path from allowing a detection of an excitation spread of a generated electrical pulse [0056].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the system yielded by the proposed combination, to provide the determining that the second electrode has not yet been inserted into the cochlea comprising determining, based on the voltage detected between the second electrode and the ground contact, that the second electrode does not detect the electrical pulse, as taught by Kabot, because different parts of the ear will have different conductivities, and the cochlear ducts where the second electrode is to be inserted are known to have high conductivity, which would allow the second electrode to detect the electrical pulse, as opposed to the second electrode being inserted in the middle ear which is filled with air, and would instead prevent a conduction path from forming, resulting in no electrical pulse being detected by the second electrode.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1:
Independent claims 1, 12, and 20 are directed a system, a method, and a system, respectively. Thus, they are directed to statutory categories of invention.
Step 2A, Prong 1:
Claims 1, 12, and 20 recite the following claim limitations which are directed to abstract ideas, specifically mental processes (see MPEP § 2106.04(a)(2)):
In re claim 1: “determining, based on the voltage detected between the second electrode and the ground contact, that the second electrode has not yet been inserted into the cochlea” (mental process – person can evaluate and analyze the detected voltage to determine whether or not the second electrode is inserted)
In re claim 12, see above.
In re claim 20, see above.
These limitations, under their broadest reasonable interpretation, cover concepts that can be practically performed in the human mind.
Therefore, the claim limitations fall within the 'mental processes' grouping of abstract ideas.
Step 2A, Prong 2:
Claims 1, 12 and 20 recite the following additional elements:
In re claim 1,
a memory storing instructions; and
one or more processors communicatively coupled to the memory and configured to execute the instructions to perform a process comprising:
directing, during an insertion procedure to insert an electrode lead into a cochlea of a patient, a first electrode on the electrode lead to generate an electrical pulse after being inserted into the cochlea;
directing, during the insertion procedure and based on the directing of the first electrode to generate the electrical pulse, a voltage to be detected between a second electrode of the electrode lead that has not yet been inserted into the cochlea and a ground contact that is to remain external to the cochlea after the insertion procedure; and
the determining that the second electrode has not yet been inserted into the cochlea comprising determining, based on the voltage detected between the second electrode and the ground contact, that the second electrode does not detect the electrical pulse.
In re claim 12, see above.
In re claim 20, see above and the following limitations:
a distal-most electrode…,
the distal-most electrode nearest of a plurality of electrodes on the electrode lead to a distal end of the electrode lead;
providing, in real time and by way of a user interface provided to a user of the system, information representative of the determination that the additional electrode has not yet been inserted into the cochlea.
The following limitations:
directing, during an insertion procedure to insert an electrode lead into a cochlea of a patient, a first electrode on the electrode lead to generate an electrical pulse after being inserted into the cochlea;
directing, during the insertion procedure and based on the directing of the first electrode to generate the electrical pulse, a voltage to be detected between a second electrode of the electrode lead that has not yet been inserted into the cochlea and a ground contact that is to remain external to the cochlea after the insertion procedure; and
the determining that the second electrode has not yet been inserted into the cochlea comprising determining, based on the voltage detected between the second electrode and the ground contact, that the second electrode does not detect the electrical pulse.
directing, during an insertion procedure to insert an electrode lead into a cochlea of a patient, a distal-most electrode to generate an electrical pulse after being inserted into the cochlea,
the distal-most electrode nearest of a plurality of electrodes on the electrode lead to a distal end of the electrode lead;
are pre-solution activities (see MPEP 2106.05(g)), because they’re used to obtain additional information used to determine that the second electrode has not yet been inserted into the cochlea.
Additionally, the limitation, “providing, in real time and by way of a user interface provided to a user of the system, information representative of the determination that the additional electrode has not yet been inserted into the cochlea”, is directed to additional elements, specifically insignificant post solution activity (see MPEP 2106.05(g)).
The above recited limitations merely process information and then output the results of the above identified abstract ideas. Additionally, the recited “provide” is neither particular enough to meaningfully limit the recited exception nor does it have more than a nominal relationship to the exception. In other words, the breadth of the recited “provide” is such that it substantially encompasses all applications of the recited exception (such as moving information).
There is nothing in the claims which show how providing the above recited limitations integrates the judicial exception into a practical application.
Further, there is no evidence of record that would support the assertion that this step is an improvement to a computer or a technological solution to a technological problem.
Regarding the limitations,
“a memory storing instructions; and
one or more processors communicatively coupled to the memory and configured to execute the instructions to perform a process comprising”,
Examiner asserts that the above recited limitations amount to nothing more than mere instructions to apply the abstract idea using a generic computer (MPEP 2106.05(f), Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983).
Additionally, the above recited claims’ recitation of
“a memory storing instructions; and
one or more processors communicatively coupled to the memory and configured to execute the instructions to perform a process comprising”
are merely reciting the computer components at a high-level of generality. In other words, the computer components are being used as a tool to carry out the system’s functions (See MPEP 2106.05(f)).
Thus, the abstract idea is not integrated into a practical application. The combination of these additional elements is no more than insignificant extra solution activity, and generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than insignificant extra solution activity and generic computer components.
The same analysis applies here in 2B and does not provide an inventive concept.
Therefore, none of the claims 1-20 amount to significantly more than the abstract idea itself. Accordingly, claims 1-20 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
Terminal Disclaimer
The terminal disclaimer filed on 07/15/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,452,866 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8 and 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kabot et al. (US 2015/0314122) in view of a second embodiment of Kabot.
In re claim 1, Kabot discloses a system [0002] comprising:
a memory [0045] storing instructions [0045]; and
one or more processors (fig. 1: 111; [0027, 0044-0045]) communicatively coupled to the memory [0045] and configured to execute the instructions to perform a process [0027, 0044-0045] comprising:
directing, during an insertion procedure [0005] to insert an electrode lead (fig. 1: 110; fig. 3: combination of electrodes E1-E8) into a cochlea of a patient (fig. 1 and fig. 7; [0022, 0027]) a first electrode (fig. 3: any one of electrodes E1-E8) on the electrode lead (fig. 3) to generate an electrical pulse [0027] after being inserted into the cochlea ([0038]: inserted electrode may generate stimulation pulses);
directing, during the insertion procedure and based on the directing of the first electrode to generate the electrical pulse ([0027]: first electrode generates stimulation), an impedance to be detected between a second electrode (fig. 4: any electrode E2 – E8 not yet inserted) of the electrode lead that has not yet been inserted into the cochlea ([0009]: electrode impedance value (EIV) measured between an electrode contact and a remote ground electrode; [0029]: electrode contact may still be outside cochlea) and a ground contact ([0005]: remote ground contact; [0009]) that is to remain external to the cochlea after the insertion procedure ([0005]: remote ground contact is outside cochlea while electrode E1 is inserted); and
determining, based on the impedance detected between the second electrode and the ground contact, that the second electrode has not yet been inserted into the cochlea ([0010: electrode impedance value compared to a threshold; [0029]: EIV for an electrode that’s not yet inserted will be higher; [0008]: insertion status determined based on measured conductivity; [0024-0025]).
Kabot fails to disclose one or more processors…perform a process comprising:
…directing, during the insertion procedure and based on the directing of the first electrode to generate the electrical pulse, a voltage to be detected between a second electrode of the electrode lead that has not yet been inserted into the cochlea and a ground contact that is to remain external to the cochlea after the insertion procedure; and
determining, based on the voltage detected between the second electrode and the ground contact, that the second electrode has not yet been inserted into the cochlea,
the determining that the second electrode has not yet been inserted into the cochlea comprising determining, based on the voltage detected between the second electrode and the ground contact, that the second electrode does not detect the electrical pulse.
Kabot teaches another embodiment ([0018]: voltage measured instead of current) comprising of one or more processors communicatively coupled to the memory and configured to execute the instructions to perform a process comprising (see above):
directing, during an insertion procedure and based on a directing of a first electrode to generate an electrical pulse (see above), a voltage to be detected [0011] between the first electrode of the electrode lead that has been inserted into the cochlea [0011] and a second contact ([0011]: voltage measured between the stimulated electrode contact and another electrode contact)
determining, based on the voltage detected between the second electrode and the ground contact, that the second electrode has been inserted correctly into the cochlea ([0037]: voltage will drop for correctly inserted electrode array).
Kabot further teaches that voltage measurements may be used to detect misplaced electrode arrays [0037-0038], for instance, if incorrectly positioned electrodes may experience a tip fold-over or loop detection [0038], therefore, using voltage to detect misplaced electrode arrays will allow for a surgeon to receive instantaneous feedback that allows for immediate correction [0038].
One of ordinary skill in the art at the time the instant invention was filed would readily appreciate that similarly to how the first embodiment of Kabot detects a insertion depth using impedance, any other parameter capable of changing when the second electrode is inserted or not could also be used to determine the insertion of the second electrode. For instance, the voltage between the second electrode and the reference electrode could be used for the determination since the voltage would change based on the second electrode being inserted or not (for instance if the second electrode was not correctly inserted).
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the system taught by Kabot, to provide directing, during the insertion procedure and based on the directing of the first electrode to generate the electrical pulse, a voltage to be detected between a second electrode of the electrode lead that has not yet been inserted into the cochlea and a ground contact that is to remain external to the cochlea after the insertion procedure; and determining, based on the voltage detected between the second electrode and the ground contact, that the second electrode has not yet been inserted into the cochlea, as similarly taught by the second embodiment of Kabot using voltage to detect proper electrode contact insertion, because doing so will provide another way of determining whether or not an electrode contact was properly inserted into the cochlea of a patient, allowing for a surgeon to receive feedback that allows for immediate correction if the electrode contact is not inserted correctly.
Regarding the limitation, “the determining that the second electrode has not yet been inserted into the cochlea comprising determining, based on the voltage detected between the second electrode and the ground contact, that the second electrode does not detect the electrical pulse”, Kabot teaches that the electrodes are inserted into cochlear ducts [0025], which are filed with perilymph [0025], a fluid known to have high conductivity [0025]. However, the middle ear [0025], where insertion is carried out [0025], is instead filled with air [0025], which is known to have zero or low conductivity [0025]. Therefore, Examiner asserts that the second electrode not being inserted in into the cochlea (i.e. it instead being in the middle ear) would result in low or zero conductivity, which is being interpreted as the electrical pulse not being detected. Further, Kabot teaches that measuring conductivity is associated with impedance values [0026-0027], which would be substituted with voltage, as yielded by the proposed combination above.
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the system yielded by the proposed combination, to provide the determining that the second electrode has not yet been inserted into the cochlea comprising determining, based on the voltage detected between the second electrode and the ground contact, that the second electrode does not detect the electrical pulse, as taught by Kabot, because different parts of the ear will have different conductivities, and the cochlear ducts where the second electrode is to be inserted are known to have high conductivity, which would allow the second electrode to detect the electrical pulse, as opposed to the second electrode being inserted in the middle ear which is filled with air, and would instead prevent a conduction path from forming, resulting in no electrical pulse being detected by the second electrode.
In re claim 2, the proposed combination yields (all mapping directed to the first embodiment of Kabot unless otherwise stated) wherein:
the first electrode is nearest of a plurality of electrodes (fig. 3: plurality of electrodes combination of isE2-E8) on the electrode lead (fig. 3) to a distal end of the electrode lead (fig. 3: first electrode E1 is closest to left side i.e. a distal end of the electrode lead);
the ground contact is a ground electrode [0005] included on a proximal portion of the electrode lead (fig. 3: proximal portion is the right side of the electrode lead) that remains external to the cochlea after the insertion procedure ([0005]: remote ground contact located outside of the cochlea and therefore be on the right side of the electrode lead; fig. 4); and
the determining that the second electrode has not yet been inserted into the cochlea includes determining that the voltage detected between the second electrode and the ground contact satisfies a predetermined threshold ([0029]: EIV compared to predetermined threshold; proposed combination in re claim 1 above would yield voltage being used instead of impedance).
In re claim 3, the proposed combination yields (all mapping directed to the first embodiment of Kabot unless otherwise stated) wherein:
the first electrode is nearest of a plurality of electrodes on the electrode lead to a distal end of the electrode lead (see in re claim 2 above);
the ground contact is a case ground (fig. 3: E8) of a cochlear implant (fig. 1) to which the electrode lead is coupled (fig. 4); and
the determining that the second electrode has not yet been inserted into the cochlea includes determining that the voltage detected between the second electrode and the ground contact satisfies a predetermined threshold (see in re claim 2 above).
In re claim 4, the proposed combination yields (all mapping directed to the first embodiment of Kabot unless otherwise stated) wherein:
the first electrode is not a distal-most electrode (fig. 5: distal-most electrode is E1 since it is closest to the left side of the electrode array) that is nearest of a plurality of electrodes (see in re claim 2 above) on the electrode lead to a distal end of the electrode lead (fig. 5: first electrode can be E2); and
the determining that the second electrode has not yet been inserted into the cochlea includes determining that the voltage detected between the second electrode and the ground contact satisfies a predetermined threshold (see in re claim 2 above).
In re claim 5, the proposed combination yields (all mapping directed to the first embodiment of Kabot unless otherwise stated) wherein:
the electrode lead comprises a plurality of electrodes including a distal-most electrode (fig. 5: distal-most electrode is E1 since its closest to the left side of the electrode array) that is nearest of a plurality of electrodes on the electrode lead to a distal end of the electrode lead (see in re claim 4 above);
the system is configured to repeatedly perform the process during the insertion procedure ([0031]: continuous measurements provided between electrode contacts and remote ground electrode) with
the distal-most electrode as the first electrode in every performance of the process ([0027]: stimulation may be provided to an electrode contact, for instance to E1 which is the distal-most electrode) and
each of the remaining electrodes of the plurality of electrodes as the second electrode during at least one performance of the process ([0031]: continuous measurements provided between each of the electrode contacts and a remote ground electrode; [0039]: one by one, electrode contacts E1-E8 are characterized as being inserted into the cochlea; [0033-0036]); and
the process further comprises:
determining, based on the repeated performances of the process, whether each of the plurality of electrodes is located within the cochlea [0031, 0039], and
determining, based on the determining of whether each of the plurality of electrodes is located within the cochlea, an insertion depth of the electrode lead within the cochlea ([0039]: determines which of the electrodes are inserted within the cochlea; [0031]).
In re claim 6, the proposed combination yields (all mapping directed to the first embodiment of Kabot unless otherwise stated) wherein the process further comprises:
providing a user interface for use by a user of the system [0010]; and
providing, to the user by way of the user interface, information representative of the determined insertion depth of the electrode lead within the cochlea ([0030]: user interface may provide insertion status such as whether electrode contact has been fully inserted; [0014]).
In re claim 7, the proposed combination yields (all mapping directed to the first embodiment of Kabot unless otherwise stated) wherein the process further comprises:
detecting, during the insertion procedure while the electrode lead is at the determined insertion depth within the cochlea (see in re claim 5 above), an occurrence of an event associated with the insertion procedure ([0030]: problem can be detected, such as an electrode tip fold-over, buckling/loop, or an air bubble); and
storing, in a storage facility associated with the system [0044-0045] and in response to the detection of the occurrence of the event,
a record representative of the occurrence of the event ([0030]: user interface provides insertion status which is a record representative of the event) and
the determined insertion depth of the electrode lead within the cochlea ([0030]: the problem would occur at a current contact electrode which provides an insertion depth of the electrode lead i.e. the position on the electrode array where the problem occurred; [0014]).
In re claim 8, the proposed combination yields (all mapping directed to the first embodiment of Kabot unless otherwise stated) wherein the event is a trauma event in which the electrode lead is detected to have caused trauma to the cochlea ([0018]: a tip fold-over or loop would cause a trauma event to the cochlea and detecting the event will allow for immediate correction by a surgeon [0038]).
In re claim 10, the proposed combination yields (all mapping directed to the first embodiment of Kabot unless otherwise stated) wherein the process further comprises:
providing a user interface [0010] for use by a user of the system [0010]; and
providing, to the user by way of the user interface, information representative of the determination that the second electrode has not yet been inserted into the cochlea ([0030]: the user interface provides an insertion status regarding whether the electrode contact was fully inserted or if a problem has arisen i.e. the second electrode has not yet been fully inserted).
In re claim 11, the proposed combination yields (all mapping directed to the first embodiment of Kabot unless otherwise stated) wherein the process is performed in real time during the insertion procedure [0010].
In re claim 12, regarding the limitation, “a method comprising:
directing, during an insertion procedure to insert an electrode lead into a cochlea of a patient,
a first electrode on the electrode lead to generate an electrical pulse after being inserted into the cochlea;
directing, during the insertion procedure and based on the directing of the first electrode to generate the electrical pulse,
a voltage to be detected between a second electrode of the electrode lead that has not yet been inserted into the cochlea and a ground contact that is to remain external to the cochlea after the insertion procedure; and
determining, based on the voltage detected between the second electrode and the ground contact, that the second electrode has not yet been inserted into the cochlea,
the determining that the second electrode has not yet been inserted into the cochlea comprising determining, based on the voltage detected between the second electrode and the ground contact, that the second electrode does not detect the electrical pulse”,
see in re claim 1 above.
In re claim 13, regarding the limitation
“wherein: the first electrode is nearest of a plurality of electrodes on the electrode lead to a distal end of the electrode lead;
the ground contact is a ground electrode included on a proximal portion of the electrode lead that remains external to the cochlea after the insertion procedure; and
the determining that the second electrode has not yet been inserted into the cochlea includes determining that the voltage detected between the second electrode and the ground contact satisfies a predetermined threshold”,
see in re claim 2 above.
In re claim 14, regarding the limitation “wherein:
the first electrode is nearest of a plurality of electrodes on the electrode lead to a distal end of the electrode lead;
the ground contact is a case ground of a cochlear implant to which the electrode lead is coupled; and the determining that the second electrode has not yet been inserted into the cochlea includes determining that the voltage detected between the second electrode and the ground contact satisfies a predetermined threshold”,
see in re claim 3 above.
In re claim 15, regarding the limitation “wherein:
the first electrode is an electrode other than a distal-most electrode that is nearest of a plurality of electrodes on the electrode lead to a distal end of the electrode lead; and
the determining that the second electrode has not yet been inserted into the cochlea includes determining that the voltage detected between the second electrode and the ground contact satisfies a predetermined threshold”,
see in re claim 4 above.
In re claim 16, regarding the limitation “wherein:
the electrode lead comprises a plurality of electrodes including a distal-most electrode that is nearest of a plurality of electrodes on the electrode lead to a distal end of the electrode lead; and
the method further comprises:
repeatedly performing the method during the insertion procedure with the distal-most electrode as the first electrode in every performance of the method and each of the remaining electrodes of the plurality of electrodes as the second electrode during at least one performance of the method,
determining, based on the repeated performances of the method, whether each of the plurality of electrodes is located within the cochlea, and
determining, based on the determining of whether each of the plurality of electrodes is located within the cochlea, an insertion depth of the electrode lead within the cochlea”,
see in re claim 5 above.
In re claim 17, regarding the limitation “wherein the method further comprises:
providing a user interface for use by a user; and
providing, to the user by way of the user interface, information representative of the determined insertion depth of the electrode lead within the cochlea”,
see in re claim 6 above.
In re claim 18, regarding the limitation “further comprising:
providing a user interface for use by a user; and
providing, to the user by way of the user interface, information representative of the determination that the second electrode has not yet been inserted into the cochlea”,
see in re claim 10 above.
In re claim 19, regarding the limitation “performed in real time during the insertion procedure”, see in re claim 11 above.
In re claim 20, regarding the limitations, “a system comprising:
a memory storing instructions; and
one or more processors communicatively coupled to the memory and configured to execute the instructions to perform a process comprising:
directing, during an insertion procedure to insert an electrode lead into a cochlea of a patient,
a…electrode to generate an electrical pulse after being inserted into the cochlea,
directing, during the insertion procedure and based on the directing of the…electrode to generate the electrical pulse, a voltage to be detected between an additional electrode of the plurality of electrodes on the electrode lead that has not yet been inserted into the cochlea and a ground contact that is to remain external to the cochlea after the insertion procedure…
determining, based on the voltage detected between the additional electrode and the ground contact, that the additional electrode has not yet been inserted into the cochlea,
the determining that the additional electrode has not yet been inserted into the cochlea comprising determining, based on the voltage detected between the additional electrode and the ground contact, that the additional electrode does not detect the electrical pulse”,
see the proposed combination yielded in re claim 1 above.
Regarding the limitations
“a distal-most electrode to generate an electrical pulse after being inserted into the cochlea,
the distal-most electrode nearest of a plurality of electrodes on the electrode lead to a distal end of the electrode lead;
directing, during the insertion procedure and based on the directing of the distal-most electrode to generate the electrical pulse, a voltage to be detected between an additional electrode of the plurality of electrodes on the electrode lead that has not yet been inserted into the cochlea and a ground contact that is to remain external to the cochlea after the insertion procedure”,
see the proposed combination yielded in re claim 5 above, where the first electrode is the distal-most electrode.
Regarding the limitation “providing, in real time and by way of a user interface provided to a user of the system, information representative of the determination that the additional electrode has not yet been inserted into the cochlea,” Kabot teaches providing, in real time [0010] and by way of a user interface [0010] provided to a user of the system [0010], information representative of the determination ([0030]: insertion status is information representative of a determination; [0010]) that the additional electrode has not yet been inserted into the cochlea ([0030]: the user interface provides an insertion status regarding whether the electrode contact was fully inserted or if a problem has arisen i.e. the second electrode has not yet been fully inserted; [0018]: the measured voltage or current may be used to determine whether an event causing the problem has occurred such as a tip fold-over, a buckling, or a loop).
Claims 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kabot et al. (US 2015/0314122) in view of a second embodiment of Kabot in view of Ramos de Miguel, Sr. et al (US 2018/0140829).
In re claim 9, the proposed combination yields (all mapping directed to the first embodiment of Kabot unless otherwise stated) wherein the process further comprises providing the stored record representative of the occurrence of the event (see in re claim 7 above).
The proposed combination fails to yield wherein the process further comprises providing …the determined insertion depth of the electrode lead within the cochlea for use in a subsequent insertion procedure of another electrode lead into a cochlea of another patient.
Ramos de Miguel, Sr. teaches a process of determining insertion based on voltage [0035], and teaches wherein a determined insertion depth of an electrode lead (fig. 3A: 145) within a cochlea [0032] is used in a subsequent insertion procedure of another electrode lead into a cochlea of another patient (the determined insertion based on voltage is compared with statistical data i.e. previous insertion depth from an electrode lead insertion of a previous cochlea of another patient; [0203]: database exists of previous cases and resulting performance).
Ramos de Miguel, Sr. further teaches that previously stored data can be used to determine whether a surgeon should attempt to reposition the electrode array [0203], and provides an automated comparison of the voltage measurements [0036].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the process yielded by the proposed combination, to provide wherein the process further comprises providing the determined insertion depth of the electrode lead within the cochlea for use in a subsequent insertion procedure of another electrode lead into a cochlea of another patient, as taught by Ramos de Miguel, Sr., because doing so provides an automated comparison of the voltage measurements and allows a surgeon to determine whether they should attempt to reposition the electrode array.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Heasman et al. (US 2021/0093852) discloses using impedance measurements [0144] to detect insertion of an electrode [0144] into a cochlea [0144].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796