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(s) filed 03/29/2024 has/have been considered by the Examiner.
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 non-statutory subject matter (abstract ideas) without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Step 1):
Claims 1-17 are directed to systems, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Claims 18-20 are directed to a method, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Step 2a) Prong One:
Independent claim 1 recites:
A system comprising: a memory storing instructions; and a processor configured to execute the instructions to perform a process comprising: measuring electrical statuses for each electrode included in a plurality of electrodes of an implantable stimulator that is implanted within a recipient; designating, based on the electrical statuses, a first set of one or more electrodes included in the plurality of electrodes as stimulating electrodes to be used to deliver electrical stimulation to the recipient; and designating, based on the electrical statuses, a second set of one or more electrodes included in the plurality of electrodes as recording electrodes to be used to record one or more signals representative of one or more evoked responses that occur within the recipient in response to the electrical stimulation.
A cochlear implant system comprising: a cochlear implant including a plurality of electrodes positioned on an electrode lead at least partially within a cochlea of a recipient; and a processing unit communicatively coupled to the cochlear implant and configured to: measure electrical statuses for each electrode included in the plurality of electrodes; designate, based on the electrical statuses, a first set of one or more electrodes included in the plurality of electrodes as stimulating electrodes to be used to deliver electrical stimulation to the recipient; and designate, based on the electrical statuses, a second set of one or more electrodes included in the plurality of electrodes as recording electrodes to be used to record one or more signals representative of one or more evoked responses that occur within the recipient in response to the electrical stimulation.
A method comprising: measuring electrical statuses for each electrode included in a plurality of electrodes of an implantable stimulator that is implanted within a recipient; designating, based on the electrical statuses, a first set of one or more electrodes included in the plurality of electrodes as stimulating electrodes to be used to deliver electrical stimulation to the recipient; and designating, based on the electrical statuses, a second set of one or more electrodes included in the plurality of electrodes as recording electrodes to be used to record one or more signals representative of one or more evoked responses that occur within the recipient in response to the electrical stimulation.
Independent claims 1 and 17-18 are all directed to MENTAL PROCESSES, where nothing in the claim elements precludes the steps from practically being performed in the human mind or by a human using pen and paper. In the instant case, a person could mentally designate by mentally assigning or selecting something in one’s head, or with assistance from pen and paper.
Dependent claims 2-16 and 19-20 contain no additional elements that integrate the abstract ideas into practical application, or amount to significantly more than the abstract idea itself. Specifically, dependent claims 2-16 and 19-20 only further define the abstract ideas (mental processes) in designating stimulating and recording electrodes. Dependent claims 5, 16 are further directed to mental processes (i.e. determining and processing). Accordingly, the dependent claims are also directed to non-statutory subject matter.
Step 2a) Prong Two:
This judicial exception is not integrated into a practical application because mere instruction to implement on a computer, or merely using a computer as a tool to perform the abstract idea, adding insignificant extra solution activity, and/or generally linking the use of the abstract idea to a technological environment or field of use is not considered integration into a practical application. The Court defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
This judicial exception is not integrated into a practical application because claims 1-20 do not disclose using the result of the mental process steps (i.e. designating), for prophylactic treatment of a particular medical condition under MPEP 2106.05(e). In the instant case, there is no specific treatment in the form of stimulation/pacing pulses, drug therapy, radiation therapy, or other forms of treatment that is ultimately used to treat a particular condition as a result of the mental process steps of designating electrodes, but is only directed to the abstract idea (mental processes) itself. Accordingly, claims 1-20 do not disclose using the result of the mental processes steps for prophylactic treatment of a particular medical condition under MPEP 2106.05(e).
This judicial exception is not integrated into a practical application because claims 1-20 do not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Specifically, the claims recite the well-understood, routine and conventional elements of a cochlear implant system comprising electrodes. The claims further recite generic computer elements (memory and processor), but these elements have not been described with sufficient detail to constitute an improvement in the tech field, as such these features merely define the field of use for the current invention by generally linking mental processes to generic computer elements as a tool to execute the abstract ideas (mental processes). By failing to explain how these elements are different from conventional computer elements, it is reasonable that the broadest reasonable interpretation of the additional elements is just a conventional computer performing generic functions (e.g., data analysis). Conventional computer elements performing basic data analysis is directed to the components of a system amounting to merely field of use type limitations and/or extra solution activity to implement the abstract idea as identified above, and merely including instructions to implement abstract ideas on a computer does not integrate the judicial exception into practical application, see MPEP 2106.04(d) Integration of a Judicial Exception into a Practical Application.
Accordingly, dependent claims 2-16 and 19-20 do not recite additional elements which practically integrate the judicial exception(s) of the current invention.
Step 2b)
Step 2B in the analysis requires us to determine whether the claims do significantly more than
simply describe that abstract method. Mayo, 132 S. Ct. at 1297. We must examine the limitations of the
claims to determine whether the claims contain an "inventive concept" to "transform" the claimed
abstract idea into patent-eligible subject matter. Alice, 134 S. Ct. at 2357 (quoting Mayo, 132 S. Ct. at
1294, 1298). The transformation of an abstract idea into patent-eligible subject matter "requires 'more
than simply stat[ing] the [abstract idea] while adding the words 'apply it."' Id. (quoting Mayo, 132 S. Ct.
at 1294) (alterations in original). "A claim that recites an abstract idea must include 'additional features'
to ensure 'that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].'" Id.
(quoting Mayo, 132 S. Ct. at 1297) (alterations in original). Those "additional features" must be more
than "well-understood, routine, conventional activity." Mayo, 132 S. Ct. at 1298.
The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recited cochlear implant system comprising electrodes, as well as the memory and processor is/are recognized as generic computer interfaces and generic computers (or computer components), because the claims do not describe these features as having distinguishing element(s) over their generic counterparts, which are well-understood, routine and conventional activities previously known in the industry, as shown in the reference as taught by Carlyon (US 20120130449 A1), which teaches a cochlear implant system with electrodes (figure 1a, cochlear stimulation device 110 and electrodes 112), and further includes a memory and processor (paragraph 0026).
Additionally, Schwarz (US 20160199642 A1) similarly teaches a cochlear implant system (abstract) with electrodes (paragraph 0004), and further includes a memory (paragraph 0069) and processor (paragraph 0005).
Thus, the present claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. When looked at individually and as a whole, the claim limitations are determined to be an abstract idea without significantly more, and thus claims 1-20 are not patent eligible under 35 USC § 101.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 2, 12 and 17 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim(s) 2, 12 and 17 is/are interpreted to read on a human organism because claims 2, 12 and 17 require the electrodes to be inserted/positioned on and/or within the ear, thereby improperly defining the structure in positive relation/connection with a living being. The claims should define the elements as being “configured to” to avoid the positive recitation.
The system of claim 1, wherein the plurality of electrodes includes at least one electrode located on an electrode lead connected to a cochlear implant and at least partially inserted within a cochlea of the recipient.
The system of claim 1, wherein the first set of one or more electrodes is positioned at a first ear of the recipient and the second set of one or more electrodes is positioned at a second ear of the recipient.
A cochlear implant system comprising: a cochlear implant including a plurality of electrodes positioned on an electrode lead at least partially within a cochlea of a recipient; and a processing unit communicatively coupled to the cochlear implant and configured to: measure electrical statuses for each electrode included in the plurality of electrodes; designate, based on the electrical statuses, a first set of one or more electrodes included in the plurality of electrodes as stimulating electrodes to be used to deliver electrical stimulation to the recipient; and designate, based on the electrical statuses, a second set of one or more electrodes included in the plurality of electrodes as recording electrodes to be used to record one or more signals representative of one or more evoked responses that occur within the recipient in response to the electrical stimulation.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 17-19 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Tarigoppula (US 20220296122 A1).
Re. claim 1, Tarigoppula teaches a system (abstract – “An exemplary insertion management system is configured to direct a cochlear implant to apply electrical stimulation by way of a first electrode disposed on an electrode lead that is being inserted into a cochlea of a recipient”) comprising:
a memory storing instructions (figure 3, storage facility 302 with instructions 306);
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and a processor (figure 3, processing facility 304; paragraph 0033 – “Processing facility 304 may be configured to perform (e.g., execute instructions 306 stored in storage facility 302 to perform) various operations…”) configured to execute the instructions to perform a process comprising:
measuring electrical statuses for each electrode included in a plurality of electrodes of an implantable stimulator that is implanted within a recipient (paragraph 0063 – “In some examples, system 300 may additionally or alternatively determine, based on a signal characteristic of signal 702 changing by at least the threshold amount, a distance between a round window of a recipient and the basal turn of the recipient”);
designating, based on the electrical statuses, a first set of one or more electrodes included in the plurality of electrodes as stimulating electrodes to be used to deliver electrical stimulation to the recipient (paragraph 0064 – “In some examples, once system 300 has determined that distal end 114 of electrode lead 110 has reached basal turn 208, system 300 may switch to a new set of stimulating and recording electrodes in order to ascertain which and/or how many electrodes have passed basal turn 208 during the lead insertion procedure. For example, with references to FIGS. 5A-5C, system 300 may initially designate electrodes 112-2 and 112-3 as stimulating electrodes and electrodes 112-1 and 112-4 as recording electrodes”);
and designating, based on the electrical statuses, a second set of one or more electrodes included in the plurality of electrodes as recording electrodes to be used to record one or more signals representative of one or more evoked responses that occur within the recipient in response to the electrical stimulation (paragraph 0064).
Re. claim 2, Tarigoppula further teaches wherein the plurality of electrodes includes at least one electrode located on an electrode lead connected to a cochlear implant and at least partially inserted within a cochlea of the recipient (figures 5A-5C).
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Re. claim 17, Tarigoppula teaches a cochlear implant system (abstract – “An exemplary insertion management system is configured to direct a cochlear implant to apply electrical stimulation by way of a first electrode disposed on an electrode lead that is being inserted into a cochlea of a recipient”) comprising:
a cochlear implant including a plurality of electrodes positioned on an electrode lead at least partially within a cochlea of a recipient (figure 4);
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and a processing unit (figure 3, processing facility 304; paragraph 0033 – “Processing facility 304 may be configured to perform (e.g., execute instructions 306 stored in storage facility 302 to perform) various operations…”) communicatively coupled to the cochlear implant and configured to:
measure electrical statuses for each electrode included in the plurality of electrodes (paragraph 0063 – “In some examples, system 300 may additionally or alternatively determine, based on a signal characteristic of signal 702 changing by at least the threshold amount, a distance between a round window of a recipient and the basal turn of the recipient”);
designate, based on the electrical statuses, a first set of one or more electrodes included in the plurality of electrodes as stimulating electrodes to be used to deliver electrical stimulation to the recipient (paragraph 0064 – “In some examples, once system 300 has determined that distal end 114 of electrode lead 110 has reached basal turn 208, system 300 may switch to a new set of stimulating and recording electrodes in order to ascertain which and/or how many electrodes have passed basal turn 208 during the lead insertion procedure. For example, with references to FIGS. 5A-5C, system 300 may initially designate electrodes 112-2 and 112-3 as stimulating electrodes and electrodes 112-1 and 112-4 as recording electrodes”);
and designate, based on the electrical statuses, a second set of one or more electrodes included in the plurality of electrodes as recording electrodes to be used to record one or more signals representative of one or more evoked responses that occur within the recipient in response to the electrical stimulation (paragraph 0064).
Re. claim 18, Tarigoppula teaches a method comprising:
measuring electrical statuses for each electrode included in a plurality of electrodes of an implantable stimulator that is implanted within a recipient paragraph 0063 – “In some examples, system 300 may additionally or alternatively determine, based on a signal characteristic of signal 702 changing by at least the threshold amount, a distance between a round window of a recipient and the basal turn of the recipient”);
designating, based on the electrical statuses, a first set of one or more electrodes included in the plurality of electrodes as stimulating electrodes to be used to deliver electrical stimulation to the recipient; (paragraph 0064 – “In some examples, once system 300 has determined that distal end 114 of electrode lead 110 has reached basal turn 208, system 300 may switch to a new set of stimulating and recording electrodes in order to ascertain which and/or how many electrodes have passed basal turn 208 during the lead insertion procedure. For example, with references to FIGS. 5A-5C, system 300 may initially designate electrodes 112-2 and 112-3 as stimulating electrodes and electrodes 112-1 and 112-4 as recording electrodes”);
and designating, based on the electrical statuses, a second set of one or more electrodes included in the plurality of electrodes as recording electrodes to be used to record one or more signals representative of one or more evoked responses that occur within the recipient in response to the electrical stimulation (paragraph 0064).
Re. claim 19, Tarigoppula further teaches wherein the plurality of electrodes includes at least one electrode located on an electrode lead connected to a cochlear implant and at least partially inserted within a cochlea of the recipient (figures 5A-5C).
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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.
Claim(s) 3-5 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tarigoppula (US 20220296122 A1) in view of Koka (US 20200171301 A1 – hereinafter Koka).
Re. claim 3, Tarigoppula teaches the claimed invention of claim 1 as stated above, but does not explicitly teach wherein the measuring the electrical statuses includes measuring impedances for each electrode included in the plurality of electrodes, the measuring the impedances comprising: sequentially applying current by way of each electrode included in the plurality of electrodes; measuring voltages associated with the current at each electrode; and determining, based on the voltages, an impedance value representative of an impedance for each electrode.
Koka teaches a similar cochlear implant system (paragraph 0022; figure 1),
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And further teaches an impedance measurement facility 502 (figure 5; paragraph 0047 – “Impedance measurement facility 502 may include or be implemented by one or more physical computing devices (e.g., including hardware and/or software such as processors, memories, communication interfaces, instructions stored in memory for execution by the processors, etc.) such as computing device 302, computing components included in sound processor 104, and/or other suitable computing devices that perform various operations associated with performing impedance measurements (e.g., excitation spread measurements)…”) which sequentially measures impedance for each stimulating electrode after delivering electrical pulses to each electrode (paragraph 0047 – “As such, impedance measurement facility 502 may be configured to perform one or more excitation spread measurements by, for example, directing a first electrode (e.g., a stimulating electrode included in a plurality of electrodes disposed on an electrode lead included within a cochlear implant system) to generate an electrical pulse, and, in response to the generation of the electrical pulse, detecting a voltage between a second electrode and a reference (e.g., performing the voltage detection using a second electrode included within the plurality of electrodes and a reference such as a ground electrode that are both distinct from the first electrode). Impedance measurement facility 502 may perform excitation spread measurements for one electrode or, in certain examples, sequentially for all the stimulating electrodes included on an electrode lead“).
Therefore, 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 system of Tarigoppula, to incorporate the sequential electrode impedance measuring as taught by Koka, since such modification would predicably result in ensuring accurate measurements are obtained by the electrodes (Koka paragraph 0029).
Re. claim 4, the combined invention of Tarigoppula and Koka further teaches wherein the measuring the voltages includes measuring voltages between each stimulated electrode AND one or more return electrodes, the one or more return electrodes including one or more of a designated ground electrode, a case of the implantable stimulator, OR one or more non-stimulated electrodes included in the plurality of electrodes (Koka paragraph 0022 – “As one example of how an excitation spread measurement may be performed, the electrode locating system may direct a first electrode to generate an electrical pulse and, in response to the generation of the electrical pulse, may detect a voltage between a second electrode (e.g., an electrode that may also be used as a stimulating electrode or a ground electrode) and a reference (e.g., a ground electrode, a case ground of a cochlear implant device, etc.) where both the second electrode and the reference are distinct from the first electrode”).
Re. claim 5, the combined invention of Tarigoppula and Koka further teaches wherein the designating the first set of one or more electrodes and the second set of one or more electrodes is based on determining one or more minimum impedance values (Tarigoppula figure 7 tracks impedance value increases as it travels through the cochlea to provide the minimum impedance needed to designate stimulating and recording electrodes; paragraph 0064 – “…system 300 may initially designate electrodes 112-2 and 112-3 as stimulating electrodes and electrodes 112-1 and 112-4 as recording electrodes. Once, distal end 114 of electrode lead 110 reaches basal turn 208, system 300 may stop using electrodes 112-1 through 112-4 as stimulating and recording electrodes and instead use electrodes 112-6 and 112-7 as stimulating electrodes and electrodes 112-5 and 112-8 as recording electrodes”).
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Re. claim 20, Tarigoppula teaches the claimed invention of claim 18 as stated above, but does not explicitly teach wherein the measuring the electrical statuses includes measuring impedances for each electrode included in the plurality of electrodes, wherein the designating the first set of one or more electrodes and the second set of one or more electrodes includes determining one or more electrodes having lower impedances than another electrode included in the plurality of electrodes.
Koka teaches a similar cochlear implant system (paragraph 0022; figure 1),
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And further teaches an impedance measurement facility 502 (figure 5; paragraph 0047 – “Impedance measurement facility 502 may include or be implemented by one or more physical computing devices (e.g., including hardware and/or software such as processors, memories, communication interfaces, instructions stored in memory for execution by the processors, etc.) such as computing device 302, computing components included in sound processor 104, and/or other suitable computing devices that perform various operations associated with performing impedance measurements (e.g., excitation spread measurements)…”) which measures impedances for each electrode included in the plurality of electrodes (paragraph 0047 – “As such, impedance measurement facility 502 may be configured to perform one or more excitation spread measurements by, for example, directing a first electrode (e.g., a stimulating electrode included in a plurality of electrodes disposed on an electrode lead included within a cochlear implant system) to generate an electrical pulse, and, in response to the generation of the electrical pulse, detecting a voltage between a second electrode and a reference (e.g., performing the voltage detection using a second electrode included within the plurality of electrodes and a reference such as a ground electrode that are both distinct from the first electrode). Impedance measurement facility 502 may perform excitation spread measurements for one electrode or, in certain examples, sequentially for all the stimulating electrodes included on an electrode lead“).
Koka further teaches wherein the designating the first set of one or more electrodes and the second set of one or more electrodes includes determining one or more electrodes having lower impedances than another electrode included in the plurality of electrodes (Impedance measurements for each electrode can be made and stored via impedance data 508 in storage facility 506, shown in figure 6 and detailed in paragraph 0050 – “Impedance data 508 may include data representative of impedance measurements (e.g., excitation spread measurements between different electrodes) that have been made, or data used to make such measurements (e.g., data representative of voltage or current levels for electrical pulses to be generated, data representative of timing information for detecting voltages in response to generated electrical pulses, etc.), or the like”).
Therefore, 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 system of Tarigoppula, to incorporate the electrode impedance measuring as taught by Koka, since such modification would predicably result in ensuring accurate measurements are obtained by the electrodes (Koka paragraph 0029).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tarigoppula (US 20220296122 A1) in view of Saoji (US 20120179223 A1 – hereinafter Saoji).
Re. claim 6, Tarigoppula teaches stimulating and recording electrodes, as well as the assignation of stimulating and recording electrodes as stated above in claim 1, but does not explicitly teach wherein the designating the first set of one or more electrodes and the second set of one or more electrodes is further based on the second set of one or more electrodes being spaced a minimum distance away from the first set of one or more electrodes.
Saoji teaches a similar cochlear implant system (figure 1),
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And teaches that non-adjacent stimulating electrodes can be selected based on minimum distance from one another (paragraph 0061 – “For example, sound processing unit 106 and/or cochlear implant system 110 may select non-adjacent electrodes that are within a predetermined distance (e.g., 4 mm or any other distance) of each other”; paragraph 0087 – “…the non-adjacent electrodes may be selected based on a separation distance that separates them one from another”), thereby designating stimulating electrodes based on distance.
Therefore, 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 designation of stimulation and recording electrodes as taught by Tarigoppula, to incorporate the electrode selection based on distance, as taught by Saoji, since such modification would predictably result in ensuring accurate measurements are obtained by the electrodes.
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tarigoppula (US 20220296122 A1) in view of Qu (US 20160220819 A1 – hereinafter Qu).
Re. claim 7, Tarigopppula teaches the claimed invention of claim 1 as stated above, but does not explicitly teach wherein the measuring the electrical statuses includes measuring stimulation artifacts for combinations of electrodes included in the plurality of electrodes, and wherein the measuring the stimulation artifacts includes directing the combinations of electrodes to sequentially apply electrical stimulation and record one or more signals representative of stimulation artifacts in response to the electrical stimulation.
Qu teaches an electrical stimulation system which measures impedance (paragraph 0043 – impedance measurement circuit 112), and further teaches the known technique of measuring stimulation artifacts for combinations of electrodes included in the plurality of electrodes, wherein the measuring the stimulation artifacts includes directing the combinations of electrodes to sequentially apply electrical stimulation and record one or more signals representative of stimulation artifacts in response to the electrical stimulation (paragraph 0059 – “For measuring pacing artifacts at systole (i.e., as in FIG. 3), at block 710, a pacing pulse is delivered by distal electrode 126.sub.1 during a systolic phase. At block 712, artifact unipolar IEGMs including electrical artifacts are recorded for each of sensing electrodes 126.sub.2, 126.sub.3, and 126.sub.4. At block 714, control unipolar IEGMs (i.e., not including electrical artifacts) are recorded for each of sensing electrodes 126.sub.2, 126.sub.3, and 126.sub.4. At block 716, the amplitude of the electrical, or pacing, artifacts for each sensing electrode 126.sub.2, 126.sub.3, and 126.sub.4 is determined…”).
Therefore, 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 system of Tarigoppula to incorporate the stimulation artifact measurement to each electrode as taught by Qu since such modification would predictably result in ensuring accurate data analysis during stimulation.
Re. claim 9, the combined invention of Tarigoppula and Qu (hereinafter the combined invention) further teaches wherein the measuring the stimulation artifacts includes applying the electrical stimulation with varying stimulation parameters (Tarigoppula paragraph 0023 – “Sound processor 104 may process the audio signal in accordance with a selected sound processing strategy or program to generate appropriate stimulation parameters for controlling cochlear implant 108”; paragraph 0063 – “Data representative of this distance may be used by system 300 to set one or more stimulation parameters for cochlear implant system 100 and/or for any other reason as may serve a particular implementation”).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tarigoppula (US 20220296122 A1) in view of Qu (US 20160220819 A1 – hereinafter Qu), and in further view of Akhoun (US 20170080226 A1 – hereinafter Akhoun).
Re. claim 8, the combined invention of Tarigoppula and Qu (hereinafter the combined invention) teaches the claimed invention of claim 7 as stated above, but does not explicitly teach wherein the measuring the stimulation artifacts includes applying the electrical stimulation below a stimulation threshold at which the one or more evoked responses are evoked.
Akhoun teaches a similar cochlear implant (abstract – “A system includes a cochlear implant (CI) device and a screening device”; figure 2), and further teaches the known technique of stimulating below a stimulation threshold at which the one or more evoked responses are evoked (paragraph 0054 – “In a second step, shown in diagram (2) of FIG. 7, an ECAP measurement is conducted at a second current level X.sub.L which is so low that no valid ECAP level is expected (indicated at “ECAP1” in diagram (2), i.e. at a current level which is below the (roughly) expected ECAP threshold current level (indicated at “first ECAP” in diagram (2))”).
Therefore, 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 combined invention, to incorporate the below ECAP threshold stimulation as taught by Akhoun, since such modification would predictably result in ensuring accurate neural response testing.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tarigoppula (US 20220296122 A1) in view of Qu (US 20160220819 A1 – hereinafter Qu), and in further view of Nogueira (US 20140336725 A1 – hereinafter Nogueira).
Re. claim 10, the combined invention of Tarigoppula and Qu (hereinafter the combined invention) teaches the claimed invention of claim 7 as stated above, but does not explicitly teach wherein the measuring the stimulation artifacts includes applying the electrical stimulation using asymmetric pulses.
Nogueira teaches a similar cochlear implant system (abstract – “An exemplary method of lowering a pitch sensation as perceived by a cochlear implant patient includes…”; cochlear implant 110), and further teaches the known technique of applying electrical stimulation using asymmetric pulses (paragraph 0042 – “By directing cochlear implant 110 to apply one or more asymmetric anode-cathode biphasic stimulation pulses, such as pulse 602, to the most apical electrode, control facility 304 may lower the pitch sensation perceived by some patients even more than that which can be achieved with one or more symmetric anode-cathode biphasic stimulation pulses. It will be recognized, however, that the change in pitch sensation that may result by using asymmetric anode-cathode biphasic stimulation…”).
Therefore, 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 combined invention, to incorporate the asymmetric stimulation pulses, as taught by Nogueira since such modification would predicably result in in ensuring accurate neural response testing and measuring.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tarigoppula (US 20220296122 A1) in view of Qu (US 20160220819 A1 – hereinafter Qu), and in further view of Sawchuk (US 20040088018 A1 – hereinafter Sawchuk).
Re. claim 11, the combined invention of Tarigoppula and Qu (hereinafter the combined invention) teaches the claimed invention of claim 7 as stated above, but does not explicitly teach wherein the designating the first set of one or more electrodes and the second set of one or more electrodes is based on reducing the stimulation artifacts.
Sawchuk teaches an electrical stimulation system (abstract) which assigns sensing and stimulation electrodes, and further teaches the known technique of designating first set of one or more electrodes and second set of one or more electrodes based on reducing the stimulation artifacts (paragraph 0009 – “Selection of separate sensing electrodes for sensing the evoked response, different than the electrode pair used for delivering the pacing pulse, can reduce or eliminate polarization artifact problems”).
Therefore, 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 system of the combined invention, to incorporate the electrode selection techniques as taught by Sawchuk since such modification would predicably result in ensuring accurate neural response testing and measuring.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tarigoppula (US 20220296122 A1) in view of Menzl (US 20150334495 A1 – hereinafter Menzl).
Re. claim 12, Tarigoppula teaches the claimed invention of claim 1 as stated above, but does not explicitly teach wherein the first set of one or more electrodes is positioned at a first ear of the recipient and the second set of one or more electrodes is positioned at a second ear of the recipient.
Menzl teaches a similar cochlear implant system comprising a first set of one or more electrodes positioned at a first ear of the recipient and second set of one or more electrodes positioned at a second ear of the recipient (paragraph 0054 – “FIG. 8 shows an exemplary bilateral auditory prosthesis system 800 that may be fitted to a patient. As shown, bilateral auditory prosthesis system 800 includes a first auditory prosthesis system 802-1 associated with a first ear of the patient and a second auditory prosthesis system 802-2 associated with a second ear of the patient. Each auditory prosthesis system 802-1 and 802-2 may detect an audio signal and provide electrical and/or acoustic stimulation representative of the audio signal to its respective ear”).
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Therefore, 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 cochlear implant system of Tarigoppula, to incorporate the second cochlear implant system to a second ear, as taught by Menzl, since such modification would predictably result in providing independent and controlled bilateral stimulation to a user’s ear.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tarigoppula (US 20220296122 A1) in view of Litvak (US 20160243361 A1 – hereinafter Litvak).
Re. claims 13-14, Tarigoppula teaches the claimed invention of claim 1 as stated above, but does not explicitly teach wherein the second set of one or more electrodes are configured to continuously record the one or more signals during an acquisition window, AND wherein the acquisition window is between 0 seconds and 2 seconds from applying the electrical stimulation.
Litvak teaches a similar cochlear implant system (figure 1), and further teaches the known techniques of continuously recording one or more signals during an acquisition window, and wherein the acquisition window is between 0 seconds and 2 seconds from applying the electrical stimulation (figure 6 shows continuous evoked response 602 recording between 0 to about 2 ms; paragraph 0044 – “FIG. 6 illustrates an exemplary evoked response 602 that may occur in response to a presentation of tone 502 in isolation”).
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Therefore, 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 electrodes of Tarigoppula, to incorporate the continuous evoked response monitoring window as taught by Litvak, since such modification would predictably result in ensuring accurate neural response testing and measuring.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tarigoppula (US 20220296122 A1) in view of Mao (US 20210307656 A1 – hereinafter Mao).
Re. claim 15, Tarigoppula teaches the claimed invention of claim 1 as stated above, but does not explicitly teach wherein the one or more evoked responses include one or more auditory evoked potentials from auditory cortical areas.
Mao teaches a similar cochlear implant system (paragraph 0060 – “Stimulation member 145 may be a speaker, earphone, hearing aid, hearing instrument, implantable auditory prosthesis comprising implantable electrodes, cochlear implant…”) and further teaches the known technique of measuring evoked responses from auditory cortical areas (paragraph 0084 – “Electrodes 180 may be positioned on a scalp 160 of a patient, in a position that allows electrodes 180 to record the cortical auditory evoked potential in response to the stimuli delivered by stimulation member 145”).
Therefore, 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 cochlear implant system of Tarigoppula, to incorporate the measurement of evoked responses from auditory cortical areas, as taught by Mao, since such modification would predicably result in ensuring accurate signal measurements from the auditory cortical areas.
Re. claim 16, Tarigoppula teaches the claimed invention of claim 1 as stated above, but does not explicitly teach wherein the process further comprises processing the one or more signals to determine one or more properties of the one or more evoked responses.
Mao teaches a similar cochlear implant system (paragraph 0060 – “Stimulation member 145 may be a speaker, earphone, hearing aid, hearing instrument, implantable auditory prosthesis comprising implantable electrodes, cochlear implant…”) and further teaches the known technique of processing the one or more signals to determine one or more properties of the one or more evoked responses (response signals can be processed and analyzed, including for peak-to-peak amplitudes 935 as per figure 9A, paragraph 0073 – “According to some embodiments, and as described below with reference to FIGS. 9A and 9B, the method may also or alternatively use other features of the response, such as the peak-to-peak amplitude, root mean square (RMS), or spectral power of the response”).
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Therefore, 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 cochlear implant system of Tarigoppula, to incorporate the measurement and processing of evoked responses for determining its properties, as taught by Mao, since such modification would predicably result in analyzing evoked responses for ensuring accurate signal measurements and efficient stimulation delivery.
Conclusion
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/ANH-KHOA N DINH/Examiner, Art Unit 3796