DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/15/2025 has been entered.
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 .
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.
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 an abstract idea without significantly more.
Claim 1 recites a system (machine), which falls into a statutory category. This method includes only one step of programming a processor to perform one or more tasks. The limitation of delivering an electrical therapy signal, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a processor…configured to execute the instructions to…determine, while the differential voltage signal is being recorded, that a signal characteristic of the differential voltage signal changes by at least a threshold amount; and determine, based on the signal characteristic changing by at least the threshold amount, that a distal end of the electrode lead is positioned within a threshold distance of a basal turn of the cochlea,” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “a processor…configured to execute the instructions to” language, “determine” in the context of this claim encompasses the user manually determining that a signal characteristic of the differential voltage signal changes by at least a threshold amount and that a distal end of the electrode lead is positioned within a threshold distance of a basal turn of the cochlea. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the abstract idea – a processor…configured to execute the instructions to…determine, while the differential voltage signal is being recorded, that a signal characteristic of the differential voltage signal changes by at least a threshold amount; and determine, based on the signal characteristic changing by at least the threshold amount, that a distal end of the electrode lead is positioned within a threshold distance of a basal turn of the cochlea. Furthermore, the newly amended limitations “display, within an interface displayed on a display device” are additional elements and are directed to insignificant extrasolution activity since it merely amounts to necessary data gathering and outputting from one device to another. Therefore, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Using a generic computer component to merely perform instructions cannot provide an inventive concept. Therefore, claim 1 is not patent eligible.
Claims 2-12 do not include additional elements that are sufficient to amount to significantly more than the judicial exception explained above. Using a generic computer component to merely perform instructions cannot provide an inventive concept. Therefore, claims 2-12 are not patent eligible.
Similarly, Claim 13 recites a method (process), which falls into a statutory category. This method includes only one step of directing an insertion management system to perform one or more tasks. The limitation of “determining, by the insertion management system while the differential voltage signal is being recorded, that a signal characteristic of the differential voltage signal changes by at least a threshold amount; and determining, by the insertion management system based on the signal characteristic changing by at least the threshold amount, that a distal end of the electrode lead is positioned within a threshold distance of a basal turn of the cochlea,” as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “determining, by the insertion management system,” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “determining, by the insertion management system” language, “determining, by the insertion management system while the differential voltage signal is being recorded, that a signal characteristic of the differential voltage signal changes by at least a threshold amount; and determining, by the insertion management system based on the signal characteristic changing by at least the threshold amount, that a distal end of the electrode lead is positioned within a threshold distance of a basal turn of the cochlea” in the context of this claim encompasses the user manually determining that a signal characteristic of the differential voltage signal changes by at least a threshold amount and determining that a distal end of the electrode lead is positioned within a threshold distance of a basal turn of the cochlea. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the abstract idea – determining, by the insertion management system while the differential voltage signal is being recorded, that a signal characteristic of the differential voltage signal changes by at least a threshold amount; and determining, by the insertion management system based on the signal characteristic changing by at least the threshold amount, that a distal end of the electrode lead is positioned within a threshold distance of a basal turn of the cochlea. Furthermore, the newly amended limitations “display, within an interface displayed on a display device” are additional elements and are directed to insignificant extrasolution activity since it merely amounts to necessary data gathering and outputting from one device to another. Therefore, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Using a generic computer component to merely perform instructions cannot provide an inventive concept. Therefore, claim 13 is not patent eligible.
Claims 14-19 do not include additional elements that are sufficient to amount to significantly more than the judicial exception explained above. Using a generic computer component to merely perform instructions cannot provide an inventive concept. Therefore, claims 14-19 are not patent eligible.
Finally, Claim 20 recites a method (process), which falls into a statutory category. This method includes only one step of programming a sound processor to perform one or more tasks. The limitation “a sound processor configured to…determine, while the differential voltage signal is being recorded, a rate of change associated with an impedance determined based on the differential voltage signal; and determine, when the rate of change decreases by greater than a threshold amount, that a distal end of the electrode lead is positioned within a threshold distance of a basal turn of the cochlea,” as drafted, is a machine that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a sound processor configured to,” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “a sound processor configured to” language, “determine” in the context of this claim encompasses the user manually determining a rate of change associated with an impedance determined based on the differential voltage signal and that a distal end of the electrode lead is positioned within a threshold distance of a basal turn of the cochlea. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the abstract idea – a sound processor configured to…determine, while the differential voltage signal is being recorded, a rate of change associated with an impedance determined based on the differential voltage signal; and determine, when the rate of change decreases by greater than a threshold amount, that a distal end of the electrode lead is positioned within a threshold distance of a basal turn of the cochlea. Furthermore, the newly amended limitations “display, within an interface displayed on a display device” are additional elements and are directed to insignificant extrasolution activity since it merely amounts to necessary data gathering and outputting from one device to another. Therefore, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Using a generic computer component to merely perform instructions cannot provide an inventive concept. Therefore, claim 20 is not patent eligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 5-6, 9-14, 17-18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vanpoucke, (US 8532781).
Regarding claim 1, Vanpoucke (Figures 1-6 and 9-10) discloses a system (400), (Col. 6, lines 15-16), comprising: a memory (510) storing instructions; and a processor (520) communicatively coupled to the memory (510), (Col. 6, lines 48-52), and configured to execute the instructions to: wirelessly transmit, by way of a wireless communication link (inductive link) between a first coil (implantable coil) disposed within a headpiece and a second coil (external coil) physically coupled to a cochlear implant (100), (Col. 4, lines 18-30), stimulation parameters to the cochlear implant (100), the stimulation parameters configured to cause the cochlear implant (100) to apply electrical stimulation by way of a first electrode (a first electrode 150) disposed on an electrode lead (160) while the electrode lead is being inserted into a cochlea (300) of a recipient (Col. 8, lines 8-18); wirelessly transmit, by way of the wireless communication link (Col. 4, lines 18-30: inductive link), a command to the cochlear implant (100) to record, while the electrical stimulation is being applied by way of the first electrode (first electrode 150), a differential voltage signal representative of a differential voltage between only a second electrode (a second electrode 150 different from the first electrode 150) and a third electrode (a third electrode 150 different from the first and second electrodes 150) both disposed on the electrode lead (160), the second and third electrodes different than the first electrode (the three electrodes are separate electrodes on electrode lead 160), (Col. 8, lines 8-18: stimulation is applied to each electrode 150 and differential voltages of all electrodes 150 are measured while the stimulation is applied such that a complete potential profile along the cochlea 300 is obtained); determine, while the differential voltage signal is being recorded, that a signal characteristic of the differential voltage signal changes by at least a threshold amount (Col. 8, lines 42-49: the “slope”/normalized differential voltage value is the impedance, therefore impedance is used as the signal characteristic of the differential voltage signal changes); and determine, based on the signal characteristic changing by at least the threshold amount, that a distal end of the electrode lead (160) is positioned within a threshold distance of a basal turn of the cochlea (Col. 8, line 63 – Col. 9, line 10; Col. 10, line 39 – Col. 11, line 19: changes in the signal characteristic/impedance is compared to the properly functioning map as shown in Figure 9 such that the signal characteristic changing by at least the threshold amount to match Figure 9 would confirm that the electrode lead 160 is positioned within a threshold distance of a basal turn of the cochlea); display, within an interface (560) displayed on the display device (410), a graph (graphical representation) associated with the differential voltage signal in substantially real time as the differential voltage signal is being recorded (Col. 6, lines 15-48; Col. 9, lines 42-50); and display, within the interface (560) displayed on the display device (410) and in response to the determining that the distal end of the electrode lead (160) is positioned within the threshold distance of the basal turn, a graphical notification indicating that the distal end of the electrode lead (160) has reached the basal turn (Col. 8, line 62 – Col. 9, line 10: the proper representation shown in Figure 6 is the graphical notification indicating that the distal end of the electrode lead has reached the basal turn, while the representations shown for example in Figures 7A-7B are graphical notifications of improper positioning).
Regarding claim 2, Vanpoucke (Figures 1-6 and 9-10) further discloses wherein the memory (510) and the processor (520) are implemented by at least one of a sound processor (110) configured to communicate with the cochlear implant or a computing device configured to be communicatively coupled to the sound processor (Col. 6, lines 15-18).
Regarding claim 5, Vanpoucke (Figures 1-6 and 9-10) further discloses wherein the signal characteristic comprises a slope associated with the differential voltage signal (Col. 8, lines 42-49: the “slope”/normalized differential voltage value is the impedance, therefore impedance is used as the signal characteristic of the differential voltage signal changes).
Regarding claim 6, Vanpoucke (Figures 1-6 and 9-10) further discloses wherein: the processor (520) is further configured to execute the instructions to generate an impedance signal based on the differential voltage signal; and the slope corresponds to the impedance signal (Col. 8, lines 42-49: the “slope”/normalized differential voltage value is the impedance, therefore impedance is used as the signal characteristic of the differential voltage signal changes).
Regarding claim 9, Vanpoucke (Figures 1-6 and 9-10) further discloses wherein the processor (520) is further configured to execute the instructions to present, within an interface displayed on a display device (560), a progress indicator indicating a location of the electrode lead (160) within the cochlea based on the signal characteristic (Col. 6, lines 25-31 and 48-52).
Regarding claim 10, Vanpoucke (Figures 1-6 and 9-10) further discloses wherein the processor (520) is further configured to execute the instructions to determine, based on the signal characteristic, a trajectory of insertion of the electrode lead (160) into the cochlea (Col. 7, lines 15-22).
Regarding claim 11, Vanpoucke (Figures 1-6 and 9-10) further discloses wherein the processor (520) is further configured to execute the instructions to determine, based on the signal characteristic changing by at least the threshold amount, a distance between a round window of the recipient and the basal turn (Col. 5, lines 24-38; Col. 8, lines 56-62).
Regarding claim 12, Vanpoucke (Figures 1-6 and 9-10) further discloses wherein the processor (520) is further configured to execute the instructions to: direct, subsequent to determining that the distal end is positioned within the threshold distance of the basal turn, the cochlear implant (100) to apply the electrical stimulation by way of a fourth electrode (a fourth electrode 150 different from first, second, and third electrodes 150) disposed on the electrode lead (160); direct the cochlear implant (100) to record, while the electrical stimulation is being applied by way of the fourth electrode (fourth electrode 150), an additional differential voltage signal representative of a differential voltage between a fifth electrode (a fifth electrode different from the first, second, third, and fourth electrodes) and a sixth electrode (a sixth electrode different from the first, second, third, fourth, and fifth electrodes) both disposed on the electrode lead (160), the fifth and sixth electrodes different than the fourth electrode; determine, while the differential voltage signal between the fifth and sixth electrodes is being recorded, that a signal characteristic of the additional differential voltage signal changes by at least the threshold amount (Col. 8, lines 42-49: the “slope”/normalized differential voltage value is the impedance, therefore impedance is used as the signal characteristic of the differential voltage signal changes); and determine, based on the signal characteristic of the additional differential voltage signal changing by at least the threshold amount, that at least one of the fourth, fifth, and sixth electrodes is positioned within the threshold distance of the basal turn (Col. 8, lines 8-18 and 42-49; Col. 8, line 63 – Col. 9, line 10; Col. 10, line 39 – Col. 11, line 19).
Regarding claim 13, Vanpoucke (Figures 1-6 and 9-10) discloses a method comprising: wirelessly transmitting, by an insertion management system by way of a wireless communication link (inductive link) between a first (implantable) coil disposed within a headpiece and a second (external) coil physically coupled to a cochlear implant (100), (Col. 4, lines 18-30), stimulation parameters to the cochlear implant, the stimulation parameters configured to cause the cochlear implant (100) to apply electrical stimulation by way of a first electrode (a first electrode 150) disposed on an electrode lead (160) while the electrode lead is being inserted into a cochlea (300) of a recipient (Col. 8, lines 8-18); wirelessly transmitting, by the insertion management system by way of the wireless communication link (Col. 4, lines 18-30: inductive link), a command to the cochlear implant (100) to record, while the electrical stimulation is being applied by way of the first electrode, a differential voltage signal representative of a differential voltage between a second electrode (a second electrode different from the first electrode) and a third electrode (a third electrode different from the first and second electrodes) both disposed on the electrode lead (160), the second and third electrodes different than the first electrode (Col. 8, lines 8-18: stimulation is applied to each electrode 150 and differential voltages of all electrodes 150 are measured while the stimulation is applied such that a complete potential profile along the cochlea 300 is obtained); determining, by the insertion management system (410) while the differential voltage signal is being recorded, that a signal characteristic of the differential voltage signal changes by at least a threshold amount (Col. 8, lines 42-49: the “slope”/normalized differential voltage value is the impedance, therefore impedance is used as the signal characteristic of the differential voltage signal changes); and determining, by the insertion management system (410) based on the signal characteristic changing by at least the threshold amount, that a distal end of the electrode lead (160) is positioned within a threshold distance of a basal turn of the cochlea (Col. 8, line 63 – Col. 9, line 10; Col. 10, line 39 – Col. 11, line 19: changes in the signal characteristic/impedance is compared to the properly functioning map as shown in Figure 9 such that the signal characteristic changing by at least the threshold amount to match Figure 9 would confirm that the electrode lead 160 is positioned within a threshold distance of a basal turn of the cochlea); display, within an interface (560) displayed on the display device (410), a graph (graphical representation) associated with the differential voltage signal in substantially real time as the differential voltage signal is being recorded (Col. 6, lines 15-48; Col. 9, lines 42-50); and display, within the interface (560) displayed on the display device (410) and in response to the determining that the distal end of the electrode lead (160) is positioned within the threshold distance of the basal turn, a graphical notification indicating that the distal end of the electrode lead (160) has reached the basal turn (Col. 8, line 62 – Col. 9, line 10: the proper representation shown in Figure 6 is the graphical notification indicating that the distal end of the electrode lead has reached the basal turn, while the representations shown for example in Figures 7A-7B are graphical notifications of improper positioning).
Regarding claim 14, Vanpoucke (Figures 1-6 and 9-10) further discloses wherein the insertion management system (410) is implemented by at least one of a sound processor (110) configured to communicate with the cochlear implant system or a computing device associated with a cochlear implant fitting system (Col. 6, lines 15-18).
Regarding claim 17, Vanpoucke (Figures 1-6 and 9-10) further discloses wherein the signal characteristic comprises a slope associated with the differential voltage signal (Col. 8, lines 42-49: the “slope”/normalized differential voltage value is the impedance, therefore impedance is used as the signal characteristic of the differential voltage signal changes).
Regarding claim 18, Vanpoucke (Figures 1-6 and 9-10) further discloses generating, by the insertion management system, an impedance signal based on the differential voltage signal; wherein the slope corresponds to the impedance signal (Col. 8, lines 42-49: the “slope”/normalized differential voltage value is the impedance, therefore impedance is used as the signal characteristic of the differential voltage signal changes).
Regarding claim 20, Vanpoucke (Figures 1-6 and 9-10) discloses a system (400), (Col. 6, lines 15-31) comprising: a cochlear implant (100) coupled to an electrode lead (160) having a plurality of electrodes (150) positioned laterally along a length of the electrode lead (160), (Col. 3, lines 27-40); a sound processor (110) configured to: wirelessly transmit, by way of a wireless communication link (inductive link) between a first (implantable) coil disposed within a headpiece and a second (external) coil physically coupled to the cochlear implant (100), (Col. 4, lines 18-30), stimulation parameters to the cochlear implant, the stimulation parameters configured to cause the cochlear implant (100) to apply, during an insertion of the electrode lead (160) into a cochlea of a recipient, electrical stimulation by way of a first electrode (a first electrode 150) included in the plurality of electrodes (Col. 8, lines 8-18); wirelessly transmit, by way of the wireless communication link (Col. 4, lines 18-30: inductive link), a command to the cochlear implant to record, while the electrical stimulation is being applied by way of the first electrode, a differential voltage signal representative of a differential voltage between at least two electrodes (two other electrodes 150 different from first electrode 150) included in the plurality of electrodes, the at least two electrodes being different from the first electrode (Col. 8, lines 8-18: stimulation is applied to each electrode 150 and differential voltages of all electrodes 150 are measured while the stimulation is applied such that a complete potential profile along the cochlea 300 is obtained); determine, while the differential voltage signal is being recorded, a rate of change associated with an impedance determined based on the differential voltage signal (Col. 8, lines 42-49: the “rate of change”/normalized differential voltage value is the impedance, therefore impedance is used as the rate of change of the differential voltage signal changes); and determine, when the rate of change decreases by greater than a threshold amount, that a distal end of the electrode lead is positioned within a threshold distance of a basal turn of the cochlea (Col. 8, line 63 – Col. 9, line 10; Col. 10, line 39 – Col. 11, line 19: changes in the rate of change is compared to the properly functioning map as shown in Figure 9 such that the rate of change changing by at least the threshold amount to match Figure 9 would confirm that the electrode lead 160 is positioned within a threshold distance of a basal turn of the cochlea); and a computing device (520) configured to display, within an interface (560) displayed on the display device (410), a graph (graphical representation) associated with the differential voltage signal in substantially real time as the differential voltage signal is being recorded (Col. 6, lines 15-48; Col. 9, lines 42-50); and display, within the interface (560) displayed on the display device (410) and in response to the determining that the distal end of the electrode lead (160) is positioned within the threshold distance of the basal turn, a graphical notification indicating that the distal end of the electrode lead (160) has reached the basal turn (Col. 8, line 62 – Col. 9, line 10: the proper representation shown in Figure 6 is the graphical notification indicating that the distal end of the electrode lead has reached the basal turn, while the representations shown for example in Figures 7A-7B are graphical notifications of improper positioning).
Regarding claim 21, Vanpoucke (Figures 1-6 and 9-10) further discloses wherein the processor (520) is further configured to execute the instructions to transmit, in response to the determining that the distal end of the electrode lead (160) is positioned within the threshold distance of the basal turn, a command to a tool used to perform a lead insertion procedure to release a stylet from the electrode lead (160), (Col. 8, line 62 – Col. 9, line 10: the proper representation shown in Figure 6 is the graphical notification indicating that the distal end of the electrode lead has reached the basal turn, while the representations shown for example in Figures 7A-7B are graphical notifications of improper positioning; therefore, the proper representation shown in Figure 6 is the graphical command to release a stylet from the electrode lead).
Regarding claim 22, Vanpoucke (Figures 1-6 and 9-10) further discloses wherein the processor (520) is further configured to execute the instructions to set, based on the determining that the distal end of the electrode lead (160) is positioned within the threshold distance of the basal turn, one or more stimulation parameters for the cochlear implant (100), (Col. 5, line 54 – Col. 6, line 10).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 3-4 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vanpoucke, as applied to claims 1 and 13 above, and further in view of Carter et al., (US 20180280687; hereinafter Carter).
Regarding claims 3-4, Vanpoucke fails to disclose wherein the directing of the cochlear implant to apply the electrical stimulation comprises directing the cochlear implant to apply a sequence of bipolar stimulation pulses by way of the first electrode and a fourth electrode, further wherein as determined along a length of the electrode lead, the second electrode is positioned closest to a distal end of the electrode lead, and the first electrode and the fourth electrode are positioned adjacent one another in between the second and third electrodes. However, Carter (Figure 15) teaches a cochlear implant insertion system applying a sequence of bipolar stimulation pulses by way of first (A) and fourth (B) electrodes ([0078]). 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 monopolar stimulating system disclosed by Vanpoucke with the bipolar stimulation system taught by Carter, because both stimulating systems perform the same function of providing a stimulation signal for a receiver/stimulator system to acquire information about electrode array position, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B). Furthermore, since the Vanpoucke system measures differential voltage of all electrodes while stimulation is applied, the modified Vanpoucke/Carter system would comprise pairs of electrodes being stimulated and all electrodes being used for differential voltage measurement while the stimulation is applied. Therefore, the modified system would at least at one point include a pair of first and fourth electrodes applying stimulation and second/third electrodes outside the pair of stimulation electrodes used for differential voltage measurement, wherein the second measurement electrode may be positioned closest to a distal end of the electrode lead, and the first+fourth stimulating electrode are positioned adjacent one another in between the second and third measurement electrodes.
Regarding claims 15-16, Vanpoucke fails to disclose wherein the directing of the cochlear implant to apply the electrical stimulation comprises directing the cochlear implant to apply a sequence of bipolar stimulation pulses by way of the first electrode and a fourth electrode, further wherein as determined along a length of the electrode lead, the second electrode is positioned closest to a distal end of the electrode lead, and the first electrode and the fourth electrode are positioned adjacent one another in between the second and third electrodes. However, Carter (Figure 15) teaches a cochlear implant insertion system applying a sequence of bipolar stimulation pulses by way of first (A) and fourth (B) electrodes ([0078]). 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 monopolar stimulating system disclosed by Vanpoucke with the bipolar stimulation system taught by Carter, because both stimulating systems perform the same function of providing a stimulation signal for a receiver/stimulator system to acquire information about electrode array position, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B). Furthermore, since the Vanpoucke system measures differential voltage of all electrodes while stimulation is applied, the modified Vanpoucke/Carter system would comprise pairs of electrodes being stimulated and all electrodes being used for differential voltage measurement while the stimulation is applied. Therefore, the modified system would at least at one point include a pair of first and fourth electrodes applying stimulation and second/third electrodes outside the pair of stimulation electrodes used for differential voltage measurement, wherein the second measurement electrode may be positioned closest to a distal end of the electrode lead, and the first+fourth stimulating electrode are positioned adjacent one another in between the second and third measurement electrodes.
Response to Arguments
Applicant's arguments filed 12/15/2025 have been fully considered.
Applicant’s first argument with regard to the rejections under 35 U.S.C. 101 is not persuasive. The newly amended limitations “display, within an interface displayed on a display device” are additional elements and are directed to insignificant extrasolution activity since it merely amounts to necessary data gathering and outputting from one device to another. Therefore, the claims does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Using a generic computer component to merely perform instructions cannot provide an inventive concept. Therefore, claims 1-20 is not patent eligible.
Applicant’s second argument with regard to the newly amended claim limitations, directed toward the display, are not persuasive. Vanpoucke discloses, in Col. 4, lines 18-30, that the system/method comprises a display device (410), wherein the processor is configured to execute the instructions to display, within an interface displayed on the display device (410), a graph (graphical representation) associated with the differential voltage signal in substantially real time as the differential voltage signal is being recorded (Col. 6, lines 15-48; Col. 9, lines 42-50); and display, within the interface displayed on the display device (410) and in response to the determining that the distal end of the electrode lead is positioned within the threshold distance of the basal turn, a graphical notification indicating that the distal end of the electrode lead has reached the basal turn (Col. 8, line 62 – Col. 9, line 10: the proper representation shown in Figure 6 is the graphical notification indicating that the distal end of the electrode lead has reached the basal turn, while the representations shown for example in Figures 7A-7B are graphical notifications of improper positioning). Therefore, Vanpoucke discloses the invention as claimed in the presently amended set of claims.
Conclusion
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
Prosecution Insights