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 .
Specification
The disclosure is objected to because of the following informalities: para. [0001] should be updated to reflect U.S. Patent Application No. 17/684,768 is now U.S. Patent No. 12,318,606.
Appropriate correction is required.
Claim Objections
Claims 3 and 19 are objected to because of the following informalities: Claims 3 and 19 recite, “initiating a feedback mechanism” (lines 4-5) and should instead state, “initiating the feedback mechanism” because the feedback mechanism has already been introduced in the independent claim. Appropriate correction is required.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-23 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-23 of prior U.S. Patent No. 10,500,392. This is a statutory double patenting rejection.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5-6, 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-6, 8-10 of U.S. Patent No. 12,318,606. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims recite essentially the same subject matter as the patented claims.
Application claim
Patent claim
Reason
1, 5-6
4
Patent recites method of monitoring acoustically-evoked inner ear potentials, determining a target stop condition (“insertion stop condition”) and responsive to this condition initiating a feedback mechanism indicating interference with basilar membrane and to stop insertion (clm 1). This insertion stop condition is predetermined from a pre-operative audiogram or from inner ear responses of the recipient’s cochlea before insertion (clm 3) and the measured inner ear responses indicate when the electrode is near a tonotopic location of the cochlea corresponding to the insertion stop frequency.
2
4 in view of 5
It would have been obvious for the feedback mechanism to stop automated insertion of the electrode array into the cochlea or generate a stop notification for a surgeon to stop insertion of the stimulating assembly in order to prevent further trauma from occurring.
3
4 in view of 6
It would have been obvious to detect an insertion warning condition and to initiate a feedback mechanism to slow insertion of the stimulating assembly into the cochlea in order to reduce the speed of insertion when nearing a stop condition to prevent trauma with tissue.
8
8
9
9
10
10
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 4 of U.S. Patent No. 11,305,109. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims recite essentially the same subject matter as the patented claims.
Application claim
Patent claim
Reason
1
3, 4
Patent recites method of pre-operatively determining an insertion stop frequency, monitoring intra-operative acoustically-evoked inner ear potentials and initiating a feedback mechanism (clm 1). The feedback mechanism is to stop or a notification to stop insertion of the stimulating assembly (clm 3-4)
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 1-12, 14-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Claims 1-12, 14-23 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, 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, a target stop condition associated with a predetermined target stop point, wherein the target stop condition comprises a relative change in the acoustically-evoked inner ear potentials indicating that 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, initiating, at the intra-operative system, a feedback mechanism indicating that the stimulating assembly has been inserted to a target insertion depth and to stop 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 acoustically-evoked inner ear potential data to evaluate whether a target stop condition comprising a relative change in the acoustically-evoked inner ear potentials has been met.
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); and do not show an improvement to technology because it is merely displaying the result of analysis of information (“initiating a feedback mechanism indicating that the stimulating assembly has been inserted to a target insertion depth and to stop insertion of the stimulating assembly into the cochlea”), TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48. 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 and initiating a feedback mechanism indicating that the stimulating assembly has been inserted to a target insertion depth and to stop insertion of the stimulating assembly into the cochlea are 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.
Claims 2 and 3 recite, “stopping automated insertion of the stimulating assembly” (clm 2) and “initiating a (see claim objection) feedback mechanism to slow insertion of the stimulating assembly into the cochlea” (clm 3). These steps are regarded as improvements to the technology and would amount to significantly more than the judicial exception itself. However since it is recited in an alternative manner and not necessarily required by the claims, these claims are also rejected as being directed to a judicial exception without significantly more.
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 7 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]).
Claim 11 is directed to a system and recites the following limitations:
a receiver configured to receive, from a cochlear implant during insertion of a stimulating assembly of the cochlear implant into a cochlea of a recipient, acoustically-evoked inner ear potentials
a processor configured to detect from the acoustically-evoked inner ear potentials, an occurrence of an insertion stop condition,
wherein the insertion stop condition is selected from a group comprising:
an error stop condition comprising a change in the acoustically-evoked inner ear potentials indicative of a mechanical impedance change of a basilar membrane of the recipient, and
a target stop condition comprising a relative change in the acoustically-evoked inner ear potentials indicating that one or more stimulating contacts of the stimulating assembly are located at a tonotopic position corresponding to a pre-operatively defined insertion stop frequency
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/detecting from acoustically-evoked inner ear potential data an occurrence of the insertion stop conditions of an error stop condition or a target stop condition through a matter of comparison, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 (Fed. Cir. 2011).
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 and do not show an improvement to the technology (“receive acoustically-evoked inner ear potentials”) TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48; or recited at a high level of generality to perform the abstract idea (“receiver”, “processor”) 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 receiver and the processor are generic computer elements and are used as a tool to perform the mental process. MPEP 2106.04(d) and 2106.05(f). 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 element improves 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 12 recites generation of a notification. This limitation does not show an improvement to technology because it is merely displaying the result of analysis of information (“initiating a feedback mechanism indicating that the stimulating assembly has been inserted to a target insertion depth and to stop insertion of the stimulating assembly into the cochlea”), TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48. 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.
Claim 13 recites, “in response to detection of the occurrence of an insertion stop condition, the processor is configured to stop an automated insertion of the stimulating assembly”. These steps are regarded as improvements to the technology and would amount to significantly more than the judicial exception itself and are patent eligible under 35 U.S.C. 101.
Claim 14 recites acoustically stimulate the cochlea of the recipient during insertion of the stimulating assembly so as to evoke inner ear potentials. This is regarded as 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 15 further defines the receiver as an external component and is directed to a generic computer element.
Claim 16 further limit the abstract idea (mental process) and adds nothing that is not already present when looking at the elements taken individually.
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 error stop condition associated with an error stop point, wherein the error stop condition comprises a change in the acoustically-evoked inner ear potentials indicative of a mechanical impedance change of a basilar membrane of the recipient;
responsive to detection of the error stop condition, initiating, at the intra-operative system, a feedback mechanism indicating that the stimulating assembly has interfered with a basilar membrane of the cochlea and to stop 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 acoustically-evoked inner ear potential data to evaluate whether an error stop condition comprising a change in the acoustically-evoked inner ear potentials has been met.
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); and do not show an improvement to technology because it is merely displaying the result of analysis of information (“initiating a feedback mechanism indicating that the stimulating assembly has interfered with a basilar membrane of the cochlea and to stop insertion of the stimulating assembly into the cochlea”), TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48. 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 and initiating a feedback mechanism indicating that the stimulating assembly has interfered with a basilar membrane of the cochlea and to stop insertion of the stimulating assembly into the cochlea are 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.
Claims 18 and 19 recite, “stopping automated insertion of the stimulating assembly” (clm 18) and “initiating a (see claim objection) feedback mechanism to slow insertion of the stimulating assembly into the cochlea” (clm 19). These steps are regarded as improvements to the technology and would amount to significantly more than the judicial exception itself. However since it is recited in an alternative manner and not necessarily required by the claims, these claims are also rejected as being directed to a judicial exception without significantly more.
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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koka et al. (US 2019/0030323; cited by applicant) in view of van Dijk (US 8,086,319) and Jolly et al. (US 2016/0220797).
Regarding claim 1, Koka et al. discloses a method, comprising: during insertion of a stimulating assembly 110 into a cochlea of a recipient, monitoring, at an intra-operative system 106, acoustically-evoked inner ear potentials obtained from the cochlea of the recipient (“monitor evoked responses that occur in response to acoustic stimulation produced at a particular frequency during an insertion procedure in which a lead that is communicatively coupled to a cochlear implant is inserted into a cochlea of a patient” [0042]; “while lead 110 is being inserted into the cochlea and while evoked responses are being monitored” [0057]); at the intra-operative system 602, detecting, based on the acoustically-evoked inner ear potentials, a target stop condition associated with a predetermined target stop point (“predetermined threshold” [0057]), wherein the target stop condition comprises a relative change in the acoustically-evoked inner ear potentials indicating that one or more stimulating contacts of the stimulating assembly are located at a tonotopic position (“Based on the measurements, monitoring system 600 (e.g., including programming system 402 and/or sound processor 104) may determine that a change between the first evoked response and the second evoked response is greater than a predetermined threshold” [0057]); and responsive to detection of the target stop condition, initiating, at the intra-operative system, a feedback mechanism indicating that the stimulating assembly has been inserted to a target insertion depth (“Based on these determinations, monitoring system 600 may notify (e.g., by an audible sound, a visible warning light, a message displayed on a graphical user interface presented by programming system 402, etc.) a user of monitoring system 600 that cochlear trauma has likely occurred at the second insertion depth of the intracochlear electrode within the cochlea.” [0057]).
Koka et al. does not expressly disclose the feedback mechanism indicates to stop insertion of the stimulating assembly into the cochlea. van Dijk teaches when an appropriate insertion depth has been determined intra-operatively, “the insertion is halted, or the electrode may be slightly withdrawn, as the electrode tip has then reached a point where residual hearing exists” cool. 7, lines 25-31). Given Koka et al. discloses the feedback mechanism already indicates when the stimulating assembly has been inserted to a target insertion depth, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further indicate to stop insertion as taught by van Dijk as it would be more effective to the recipient to stop further insertion of the stimulating assembly when it has reached a point where residual hearing exists or when cochlear trauma has likely occurred.
Koka et al. does not expressly disclose the tonotopic position corresponds to a pre-operatively defined insertion stop frequency. Jolly et al. teaches it is known in the art to use a pre-operatively defined test such as an audiogram to determine an insertion stop frequency that assists in defining a tonotopic position in the cochlea to limit insertion depth (“The insertion depth of the electrode 2000 may be controlled and limited to a pre-determined value. The pre-determined insertion depth value may be based on the patient audiogram” [0074]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Koka et al. to identify a tonotopic position with a pre-operatively defined insertion stop frequency selected from an audiogram as taught by Jolly et al. in order to enable the insertion process to be performed with some initial guideline of appropriate insertion depth.
Regarding claim 2, Koka et al. in view of van Dijk discloses generating a stop notification for a surgeon to stop insertion of the stimulating assembly (see claim 1).
Regarding claim 3, Koka et al. discloses at the intra-operative system, detecting, based on the acoustically-evoked inner ear potentials, an insertion warning condition ([0057]).
Regarding claim 4, Koka et al. discloses detecting a peak or near peak in an attribute of the acoustically-evoked inner ear potentials associated with the insertion stop frequency (“change in the amplitude of the second evoked response” [0044]; “monitoring system 600 may determine that the second evoked response is smaller in amplitude than the first evoked response by an amount greater than the predetermined threshold” [0065]; “response amplitude of evoked response curve 902 continues to increase as the cochlear depth of intracochlear electrode 112-1 increases” [0067-0068]).
Regarding claims 5-6, Koka et al. in view of Jolly et al. disclose prior to insertion of the stimulating assembly, performing one or more pre-operative tests on the cochlea; and determining the insertion stop frequency based on the one or more pre-operative tests (see claim 1); wherein performing one or more pre-operative tests on the cochlea comprises performing an audiogram measurement of the cochlea to determine at least one of frequency or frequency range where residual hearing begins in the cochlea ([0074]).
Regarding claim 7, Koka et al. discloses wherein the intra-operative system includes an external component 106 (fig. 1) of a cochlear implant 108 (fig. 1).
Regarding claim 8, Koka et al. discloses generating, during insertion of the stimulating assembly, acoustic signals for acoustic stimulation of the cochlea ([0042]), wherein the acoustic signal includes frequency components corresponding to a pre-operatively defined insertion stop frequency (Jolly et al.); and capturing the acoustically-evoked inner ear potentials in response to delivery of the acoustic signals to the cochlea ([0042]).
Regarding claim 9, Koka et al. discloses the acoustically-evoked inner ear potentials are obtained in response to one or more complex acoustic inputs having a plurality of frequencies each associated with a different tonotopic region of the cochlea ([0030], [0043], [0063]).
Regarding claim 10, Koka et al. discloses the acoustically-evoked inner ear potentials are obtained from a plurality of different contacts of the stimulating assembly ([0052], [0054]).
Claim(s) 11, 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koka et al. (US 2019/0030323; cited by applicant) in view of Jolly et al. (US 2016/0220797).
Regarding claim 11, Koka et al. discloses a system, comprising: a receiver 106 (fig. 1) configured to receive, from a cochlear implant 108 during insertion of a stimulating assembly 110 of the cochlear implant into a cochlea of a recipient, acoustically-evoked inner ear potentials (“monitor evoked responses that occur in response to acoustic stimulation produced at a particular frequency during an insertion procedure in which a lead that is communicatively coupled to a cochlear implant is inserted into a cochlea of a patient” [0042]; “while lead 110 is being inserted into the cochlea and while evoked responses are being monitored” [0057]); and a processor 602 (fig. 6) configured to detect from the acoustically-evoked inner ear potentials, an occurrence of an insertion stop condition comprising: a target stop condition comprising a relative change in the acoustically-evoked inner ear potentials indicating that one or more stimulating contacts of the stimulating assembly are located at a tonotopic position (“Based on the measurements, monitoring system 600 (e.g., including programming system 402 and/or sound processor 104) may determine that a change between the first evoked response and the second evoked response is greater than a predetermined threshold” [0057]).
Koka et al. does not expressly disclose the tonotopic position corresponds to a pre-operatively defined insertion stop frequency. Jolly et al. teaches it is known in the art to use a pre-operatively defined test such as an audiogram to determine an insertion stop frequency that assists in defining a tonotopic position in the cochlea to limit insertion depth (“The insertion depth of the electrode 2000 may be controlled and limited to a pre-determined value. The pre-determined insertion depth value may be based on the patient audiogram” [0074]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Koka et al. to identify a tonotopic position with a pre-operatively defined insertion stop frequency selected from an audiogram as taught by Jolly et al. in order to enable the insertion process to be performed with some initial guideline of appropriate insertion depth.
Regarding claim 14, Koka et al. discloses an acoustic receiver 302 configured to acoustically stimulate the cochlea of the recipient during insertion of the stimulating assembly so as to evoke inner ear potentials ([0033]; [0042]).
Regarding claim 15, Koka et al. discloses an external component of the cochlear implant, and wherein the receiver 106 is part of the external component (fig. 1).
Regarding claim 16, Koka et al. discloses the processor is configured to detect a peak or near peak in an attribute of the acoustically-evoked inner ear potentials associated with the insertion stop frequency (“change in the amplitude of the second evoked response” [0044]; “monitoring system 600 may determine that the second evoked response is smaller in amplitude than the first evoked response by an amount greater than the predetermined threshold” [0065]; “response amplitude of evoked response curve 902 continues to increase as the cochlear depth of intracochlear electrode 112-1 increases” [0067-0068]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koka et al. (US 2019/0030323; cited by applicant) in view of Jolly et al. (US 2016/0220797) and further in view of van Dijk (US 8,086,319).
Regarding claim 12, Koka et al. discloses in response to detection of the occurrence of an insertion stop condition, the processor is configured to generate a notification to a user indicating that the movement of the stimulating assembly should be at least temporarily stopped. van Dijk teaches when an appropriate insertion depth has been determined intra-operatively, “the insertion is halted, or the electrode may be slightly withdrawn, as the electrode tip has then reached a point where residual hearing exists” cool. 7, lines 25-31). Given Koka et al. discloses the feedback mechanism already indicates when the stimulating assembly has been inserted to a target insertion depth (“Based on these determinations, monitoring system 600 may notify (e.g., by an audible sound, a visible warning light, a message displayed on a graphical user interface presented by programming system 402, etc.) a user of monitoring system 600 that cochlear trauma has likely occurred at the second insertion depth of the intracochlear electrode within the cochlea.” [0057]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further indicate to stop insertion as taught by van Dijk as it would be more effective to the recipient to stop further insertion of the stimulating assembly when it has reached a point where residual hearing exists or when cochlear trauma has likely occurred.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koka et al. (US 2019/0030323; cited by applicant) in view of Jolly et al. (US 2016/0220797) and further in view of van Dijk (US 8,086,319) and Pawsey et al. (US 2018/0050196).
Regarding claim 13, Koka et al. does not expressly disclose in response to detection of the occurrence of an insertion stop condition, the processor is configured to stop an automated insertion of the stimulating assembly. van Dijk teaches when an appropriate insertion depth has been determined intra-operatively, “the insertion is halted, or the electrode may be slightly withdrawn, as the electrode tip has then reached a point where residual hearing exists” cool. 7, lines 25-31). Pawsey et al. teaches it is known in the art for an automated insertion of a stimulation assembly into the cochlea of the recipient ([0247], [0250-0251], [0265]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to automate the insertion of the stimulating assembly as taught by Pawsey et al. as it is simply automating a manual process to yield the predictable result of implanting a device. Broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art. In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further stop insertion as taught by van Dijk as it would be more effective to the recipient to stop further insertion of the stimulating assembly when it has reached a point where residual hearing exists or when cochlear trauma has likely occurred.
Claim(s) 17-20, 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koka et al. (US 2019/0030323; cited by applicant) in view of van Dijk (US 8,086,319) and as evidenced by Patrick et al. (US 2014/0350640).
Regarding claim 17, Koka et al. discloses a method comprising: during insertion of a stimulating assembly 110 into a cochlea of a recipient, monitoring, at an intra-operative system 106, acoustically-evoked inner ear potentials obtained from the cochlea of the recipient (“monitor evoked responses that occur in response to acoustic stimulation produced at a particular frequency during an insertion procedure in which a lead that is communicatively coupled to a cochlear implant is inserted into a cochlea of a patient” [0042]; “while lead 110 is being inserted into the cochlea and while evoked responses are being monitored” [0057]); at the intra-operative system 602, detecting, based on the acoustically-evoked inner ear potentials, an error stop condition associated with an error stop point (“cochlear trauma has likely occurred at the second insertion depth of the intracochlear electrode within the cochlea” [0057]), wherein the error stop condition comprises a change in the acoustically-evoked inner ear potentials ([0075], [0077], [0083]); and responsive to detection of the error stop condition, initiating, at the intra-operative system, a feedback mechanism indicating that the stimulating assembly has interfered with a basilar membrane of the cochlea (“As such, if monitoring system 600 detects that the phase changes from the first evoked response to the second evoked response, monitoring system 600 may determine that cochlear trauma has likely occurred at a particular location between first and second insertion depths 812 (e.g., at second insertion depth 812-2) and may notify a user (e.g., a surgeon performing insertion procedure 800) that cochlear trauma has likely occurred at a particular insertion depth between first and second insertion depths 812 (e.g., at second insertion depth 812-2)” [0083]).
Koka et al. does not expressly disclose the feedback mechanism indicates to stop insertion of the stimulating assembly into the cochlea. van Dijk teaches when an appropriate insertion depth has been determined intra-operatively, “the insertion is halted, or the electrode may be slightly withdrawn, as the electrode tip has then reached a point where residual hearing exists” cool. 7, lines 25-31). Given Koka et al. discloses the feedback mechanism already indicates when the stimulating assembly has been inserted to a target insertion depth, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further indicate to stop insertion as taught by van Dijk as it would be more effective to the recipient to stop further insertion of the stimulating assembly when it has reached a point where residual hearing exists or when cochlear trauma has likely occurred.
Koka et al. does not expressly disclose the change in the acoustically-evoked inner ear potentials is indicative of a mechanical impedance change of a basilar membrane of the recipient. Patrick et al. teaches impedance changes occur when there is contact of the tip of the stimulating assembly with the basilar membrane ([0103]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the acoustically-evoked inner ear potentials measured by Koka et al. where an error stop condition such as cochlear trauma occurring would be indicative of a mechanical impedance change of the basilar membrane of the recipient since Patrick et al. teaches there is a correlation between contact with the basilar membrane and impedance.
Regarding claim 18, Koka et al. in view of van Dijk discloses generating a stop notification for a surgeon to stop insertion of the stimulating assembly (see claim 17).
Regarding claim 19, Koka et al. in view of van Dijk discloses detecting, based on the acoustically-evoked inner ear potentials, an insertion warning condition (“cochlear trauma” [0057]); and responsive to detection of an insertion warning condition, initiating a feedback mechanism to slow insertion of the stimulating assembly into the cochlea (see claim 17).
Regarding claim 20, Koka et al. discloses wherein the intra-operative system includes an external component 106 (fig. 1) of a cochlear implant 108 (fig. 1).
Regarding claim 22, Koka et al. discloses the acoustically-evoked inner ear potentials are obtained in response to one or more complex acoustic inputs having a plurality of frequencies each associated with a different tonotopic region of the cochlea ([0030], [0043], [0063]).
Regarding claim 23, Koka et al. discloses the acoustically-evoked inner ear potentials are obtained from a plurality of different contacts of the stimulating assembly ([0052], [0054]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koka et al. (US 2019/0030323; cited by applicant) in view of van Dijk (US 8,086,319) and as evidenced by Patrick et al. (US 2014/0350640) and further in view of Jolly et al. (US 2016/0220797).
Regarding claim 21, Koka et al. discloses generating, during insertion of the stimulating assembly, acoustic signals for acoustic stimulation of the cochlea, wherein the acoustic signal includes frequency components (“acoustic stimulation produced at a particular frequency” [0042]); and capturing the acoustically-evoked inner ear potentials in response to delivery of the acoustic signals to the cochlea ([0042-0043]) but does not expressly disclose the frequency components correspond to a pre-operatively defined insertion stop frequency. Jolly et al. teaches it is known in the art to use a pre-operatively defined test such as an audiogram to determine an insertion stop frequency that assists in defining a tonotopic position in the cochlea to limit insertion depth (“The insertion depth of the electrode 2000 may be controlled and limited to a pre-determined value. The pre-determined insertion depth value may be based on the patient audiogram” [0074]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Koka et al. to use a frequency component in the acoustic signal corresponding to a pre-operatively defined insertion stop frequency selected from an audiogram as taught by Jolly et al. in order to enable the insertion process to be performed with some initial guideline of appropriate insertion depth.
Conclusion
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/ERICA S LEE/Primary Examiner, Art Unit 3796