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 .
Response to Amendment
The amendment filed May 15, 2026 has been entered. Claims 1-4, 8, 11-14, 17-18 and 21 have been amended. Claim 16 is canceled. Currently, claims 1-15, 17-23 are pending for examination.
Response to Arguments
Applicant's arguments filed May 15, 2026 with respect to the 35 U.S.C. 101 rejections of claims 1 and 17 have been fully considered but they are not persuasive. While the previous Office action did identify dependent claim limitations regarded as improvements to technology, the applicant’s amendments fail to incorporate the entirety what was identified as 35 U.S.C. 101 patent eligible subject matter of these dependent claim limitations in combination with the independent claims for which they depend. For example, claim 2 has deleted automated from the “stopping automated insertion of the stimulating assembly”. Similarly, applicant has deleted claim 18’s automated from “stopping automated insertion of the stimulating assembly”.
Applicant’s arguments, see pages 9-10, filed May 15, 2026, with respect to the double patenting rejection have been fully considered and are persuasive. The double patenting rejection of claims 1-3, 5-6, 8-10 has been withdrawn.
Applicant’s arguments, see page 10, filed May 15, 2026, with respect to the 35 U.S.C. 101 rejection of claims 11-16 have been fully considered and are persuasive. The 35 U.S.C. 101 rejection of claims 11-16 has been withdrawn.
Applicant’s arguments, see pages 10-12, filed May 15, 2026, with respect to the 35 U.S.C. 103 rejection of claims 1-16, 17-23 have been fully considered and are persuasive. The 35 U.S.C. 103 rejection of claims 1-16 and 17-23 has been withdrawn.
Claim Rejections - 35 USC § 101
Claims 1-10, 17-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Claims 1-10 and 17-23 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p. 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019).
Claim 1 is directed to a method and recites the following limitations:
during insertion of a stimulating assembly into a cochlea of a recipient, monitoring, at an intra-operative system, amplitudes of acoustically-evoked inner ear potentials obtained from the cochlea of the recipient;
at the intra-operative system, detecting, based on an increase between amplitudes obtained at a first insertion position of the stimulating assembly in the cochlea and amplitudes obtained at a second insertion position of the stimulating assembly relatively deeper in the cochlea than the first insertion position, a target stop condition associated with a predetermined target stop point, wherein the target stop condition indicates one or more stimulating contacts of the stimulating assembly are located at a tonotopic position corresponding to a pre-operatively defined insertion stop frequency;
responsive to detection of the target stop condition, stopping further insertion of the stimulating assembly into the cochlea
Step 2A – Prong 1: The bolded limitations are drawn to an abstract idea because they are processes that, under their broadest reasonable interpretation, are mere steps that are capable of being performed in the human mind, including observation, evaluation, judgement and opinion. For example, a skilled artisan is capable of observing/monitoring amplitudes of acoustically-evoked inner ear potential data to evaluate whether a target stop condition comprising an increase between amplitudes in the acoustically-evoked inner ear potentials between two insertion positions has been met. The limitation, “responsive to detection of the target stop condition, stopping further insertion of the stimulating assembly into the cochlea” is regarded as a method of organizing human activity. Without linking this limitation to an apparatus performing the task, stopping further insertion of the stimulating assembly is broadly recited enough to be performed by a human, thus regarded as managing personal behavior or following rules or instruction. See MPEP 2106.04(a)(2)(II).
Step 2A – Prong 2: The underlined limitations are drawn to elements beyond the judicial exception but do not integrate the exception into a practical application because they are insignificant extra-solution activity. They are either ancillary to the overall diagnostic focus of the claims (“during insertion of a stimulating assembly into a cochlea of a recipient”) Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 101 USPQ2d 1961 (2012); recited at a high level of generality to perform the abstract idea (“intra-operative system”) MPEP 2106.04(d) and 2106.05(f). The additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limitations on practicing the abstract idea.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. The intra-operative system is regarded as well-understood, routine and conventional, as evidenced by and not limited to Bouchataoui et al. (US 2013/0006328), “Such an interaction map may be used in conjunction with conventional audiometry to determine a suitable cut off frequency” ([0071]). Reciting the steps of performing monitoring during insertion of a stimulating assembly into a cochlea of a recipient is insignificant extra-solution activity. The underlined limitations do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the element taken individually. There is no indication that the limitations improve the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
Claim 2 recites, “initiating a feedback mechanism in response to detection of the target stop condition”. Without any further limitations directed to this feedback mechanism, such as what it is linked with or how it further limits the claim by improving the technology, this feedback mechanism does not further limit the claim to make claim 1 patent eligible under 35 U.S.C. 101 analysis.
Claim 3 recites, “initiating a feedback mechanism to slow insertion of the stimulating assembly into the cochlea”. If this step stated, “initiating a feedback mechanism to slow automated insertion of the stimulating assembly into the cochlea”, it would be regarded as improvements to the technology and would amount to significantly more than the judicial exception itself.
Claims 4, 8-10 recite limitations that further limit the abstract idea (mental process) or adds minimal limitations to the extra-solution activity and adds nothing that is not already present when looking at the elements taken individually.
Claims 5-6 are directed to insignificant pre-solution activity as being ancillary to the overall diagnostic focus of the claims (“during insertion of a stimulating assembly into a cochlea of a recipient”) Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 101 USPQ2d 1961 (2012).
Claim 17 is directed to a method and recites the following limitations:
during insertion of a stimulating assembly into a cochlea of a recipient, monitoring, at an intra-operative system, acoustically-evoked inner ear potentials obtained from the cochlea of the recipient;
at the intra-operative system, detecting, based on the acoustically-evoked inner ear potentials, an increase in magnitude between a first acoustically-evoked inner ear potential associated with a first insertion point of the stimulating assembly in the cochlea and a second acoustically-evoked inner ear potential associated with a second insertion position, deeper than the first insertion position, of the stimulating assembly in the cochlea;
responsive to the increase in magnitude satisfying a predetermined constraint, stopping further insertion of the stimulating assembly in the cochlea
Step 2A – Prong 1: The bolded limitations are drawn to an abstract idea because they are processes that, under their broadest reasonable interpretation, are mere steps that are capable of being performed in the human mind, including observation, evaluation, judgement and opinion. For example, a skilled artisan is capable of observing/monitoring amplitudes of acoustically-evoked inner ear potential data to evaluate whether a predetermined constraint of an increase in magnitude between amplitudes in the acoustically-evoked inner ear potentials between two insertion positions has been met. The limitation, “responsive to the increase in magnitude satisfying a predetermined constraint, stopping further insertion of the stimulating assembly into the cochlea” is regarded as a method of organizing human activity. Without linking this limitation to an apparatus performing the task, stopping further insertion of the stimulating assembly is broadly recited enough to be performed by a human, thus regarded as managing personal behavior or following rules or instruction. See MPEP 2106.04(a)(2)(II).
Step 2A – Prong 2: The underlined limitations are drawn to elements beyond the judicial exception but do not integrate the exception into a practical application because they are insignificant extra-solution activity. They are either ancillary to the overall diagnostic focus of the claims (“during insertion of a stimulating assembly into a cochlea of a recipient”) Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 101 USPQ2d 1961 (2012); recited at a high level of generality to perform the abstract idea (“intra-operative system”) MPEP 2106.04(d) and 2106.05(f). The additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limitations on practicing the abstract idea.
Step 2B: Claim 17 does not recite additional elements that amount to significantly more than the judicial exception itself. The intra-operative system is regarded as well-understood, routine and conventional, as evidenced by and not limited to Bouchataoui et al. (US 2013/0006328), “Such an interaction map may be used in conjunction with conventional audiometry to determine a suitable cut off frequency” ([0071]). Reciting the steps of performing monitoring during insertion of a stimulating assembly into a cochlea of a recipient is insignificant extra-solution activity. The underlined limitations do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the element taken individually. There is no indication that the limitations improve the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
Claim 18 recites, “generating a stop notification for a surgeon”. This does not show an improvement to technology because it is merely displaying the result of analysis of information. TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48.
Claim 19 recites, “initiating a feedback mechanism to slow insertion of the stimulating assembly into the cochlea” If this step stated, “initiating a feedback mechanism to slow automated insertion of the stimulating assembly into the cochlea”, it would be regarded as improvements to the technology and would amount to significantly more than the judicial exception itself.
Claim 20 recites the intra-operative system includes an external component of a cochlear implant. This is regarded as well-understood, routine and conventional, as evidenced by and not limited to Bouchataoui et al. (US 2013/0006328), “Such an interaction map may be used in conjunction with conventional audiometry to determine a suitable cut off frequency” ([0071]).
Claims 21-23 recite limitations that further limit the abstract idea (mental process) or adds minimal limitations to the extra-solution activity and adds nothing that is not already present when looking at the elements taken individually.
Allowable Subject Matter
Claims 11-15 are allowed.
Statement Regarding Prior Art
Koka et al. (US 2019/0030323) regarded as the closest prior art, does not disclose monitoring amplitudes of acoustically-evoked inner ear potentials obtained from the cochlea of a recipient and detecting, based on an increase between amplitudes obtained at a first insertion position of the stimulating assembly in the cochlea and amplitudes obtained at a second insertion position of the stimulating assembly relatively deeper in the cochlea than the first insertion position, a target stop condition associated with a predetermined target stop point; wherein the target stop condition indicates one or more stimulating contacts of the stimulating assembly are located at a tonotopic position corresponding to a pre-operatively defined insertion stop frequency. Koka et al. does not disclose the above limitations for the reasons identified in the Applicant’s arguments filed May 15, 2026. Milojevic et al. (US 2004/0225336) discloses an increase in frictional engagement felt by the surgeon to determine a maximum insertion depth of a cochlear implant ([0097]) but does not disclose the above limitations.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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