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 .
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 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.
Status of Claims
Claims 1, 2, 4, 5, 7-12, 14-23, 32-39, and 41-44 are pending and under consideration for patentability; claims 5, 8, and 38 have been amended; claims 3, 6, 13, 24-31, and 40 have been cancelled.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 18 June 2021, 25 January 2023, and 16 May 2023 have been acknowledged and considered by the Examiner.
Response to Arguments
Applicant’s arguments with respect to claims 1, 2, 4, 5, 7-12, 14-23, 32-39, and 41-44 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The Examiner notes that this Office Action has been made NON-FINAL.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4, 5, 7, 9, 10, 14, 33, 35-37, 43, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 2014/0100637 A1) in view of Lin et al. (US 2011/0044485 A1).
Regarding claim 1, Zhang describes an apparatus comprising an implantable portion of a medical device ([0007]: “active rejection of MRI gradient signals in an implantable medical device”), wherein the apparatus is configured to at least partially cancel a signal in the implantable portion (Abstract: “active rejection techniques are used to cancel MRI gradient signals in an implantable medical device”), the signal resulting from an external magnetic field generated external to a recipient of the medical device ([0007]: “an active component may be placed in each input channel of an implantable medical device to actively reject MRI gradient signals…a sensing circuit that senses an external MRI gradient signal generates a corresponding control signal that controls each active component”).
Regarding claim 1, although Zhang describes partially cancelling a signal resulting from an external magnetic field as part of an implantable medical device, Zhang does not explicitly disclose wherein the implantable medical device is a hearing prosthesis. However, Lin describes a hearing aid including an implantable portion incorporating external magnetic shielding ([0024]: “a dual-motor hearing aid receiver…may be used in conjunction with external magnetic shielding to allow a telecoil to be placed in close proximity to said receiver”). In addition to the advantage of allowing a telecoil to be placed in close proximity to a receiver ([0024]: “this configuration and combination of elements can permit a design with a telecoil located much closer to the receiver than previous designs that do not use a dual-motor receiver not modified for radiated field cancellation”), Lin further describes that “the proposed configuration allows telecoil placements heretofore not possible using standard dual or single-motor receivers that do not produce intentional field cancellation effects.” As Lin is also directed towards implantable medical devices which act to shield or cancel external effects, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use the steps described by Zhang as part of a hearing prosthesis, similar to that described by Lin, as doing so advantageously allows the magnetic field cancellation effects to be incorporated into a hearing prosthesis, as is a goal of Lin’s device.
Regarding claim 2, Zhang describes wherein the signal is a signal generated by the external magnetic field interacting with an electrical lead extending between a stimulation output device of the prosthesis and a stimulator and/or receiver of the implantable portion ([0024], [0029]).
Regarding claim 4, Zhang describes wherein the implantable portion of the device includes circuitry configured to at least partially cancel the signal ([0023]), the implantable portion of the device is configured with a feedforward and/or feedback circuit that enables the signal to be provided to the circuitry ([0023], for example via the detector circuit), and the circuitry is configured to at least partially cancel the signal using the output of the feed forward and/or feedback circuit ([0023]).
Regarding claim 5, Zhang describes wherein the implantable portion of the device is configured to controllably provide a cancellation signal that at least partially cancels the signal resulting from the external magnetic field ([0025] - [0026]).
Regarding claim 7, although neither Zhang nor Lin explicitly disclose wherein the signal resulting from the external magnetic field is an alternating current that has components having a frequency less than 10 kHz and is less than 100 mV, the Examiner respectfully submits that, as the apparatus suggested by an obvious combination of Zhang and Lin is fully capable of partially cancelling signals resulting from external magnetic fields, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to ensure that the resulting apparatus is capable of partially cancelling the specific frequencies and amplitudes recited by the claim, as doing so would be a matter of optimizing the prior art conditions via routine experimentation.
Regarding claim 9, Zhang describes an apparatus comprising an implantable medical device ([0007]: “active rejection of MRI gradient signals in an implantable medical device”), wherein the implantable medical device is configured to function to reduce and/or eliminate a percept that would be evoked by the device when subjected to an external magnetic field generated external to a recipient of the device in the absence of the functioning (Abstract: “active rejection techniques are used to cancel MRI gradient signals in an implantable medical device”; [0007]: “an active component may be placed in each input channel of an implantable medical device to actively reject MRI gradient signals…a sensing circuit that senses an external MRI gradient signal generates a corresponding control signal that controls each active component”).
Regarding claim 9, although Zhang describes partially cancelling a signal resulting from an external magnetic field as part of an implantable medical device, Zhang does not explicitly disclose wherein the implantable medical device is a hearing prosthesis. However, Lin describes a hearing aid including an implantable portion incorporating external magnetic shielding ([0024]: “a dual-motor hearing aid receiver…may be used in conjunction with external magnetic shielding to allow a telecoil to be placed in close proximity to said receiver”). In addition to the advantage of allowing a telecoil to be placed in close proximity to a receiver ([0024]: “this configuration and combination of elements can permit a design with a telecoil located much closer to the receiver than previous designs that do not use a dual-motor receiver not modified for radiated field cancellation”), Lin further describes that “the proposed configuration allows telecoil placements heretofore not possible using standard dual or single-motor receivers that do not produce intentional field cancellation effects.” As Lin is also directed towards implantable medical devices which act to shield or cancel external effects, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use the steps described by Zhang as part of a hearing prosthesis, similar to that described by Lin, as doing so advantageously allows the magnetic field cancellation effects to be incorporated into a hearing prosthesis, as is a goal of Lin’s device.
Regarding claim 10, Zhang describes wherein the prosthesis includes circuitry configured to at least partially cancel voltage of a signal generated by interaction of the external magnetic field with the prosthesis ([0023]).
Regarding claim 14, Zhang describes wherein the prosthesis is configured to mask an MRI induced voltage to reduce and/or eliminate the hearing percept ([0007]).
Regarding claim 33, Zhang describes wherein the signal is a signal having a frequency and amplitude ([0023], a frequency and an amplitude being inherent characteristics of an electrical signal), wherein the signal is external magnetic field interacting with an electrical lead of the apparatus extending between a stimulation output device of the prosthesis and a stimulator and/or receiver of the implantable portion ([0024], [0029]), wherein the frequency and/or amplitude of the signal is variable relative to a feature of the external magnetic field ([0027]).
Regarding claim 35, Zhang describes wherein the prosthesis is configured to dampen stimulation that results in the hearing percept via functioning of the prosthesis in an MRI mode ([0081]).
Regarding claim 36, Zhang describes wherein the implantable portion of the hearing prosthesis is configured to evoke a hearing percept based on ambient sound while at least partially cancelling the signal resulting from an external magnetic field ([0029], [0042]).
Regarding claim 37, Zhang describes wherein the implantable portion of the device includes circuitry configured to at least partially cancel the signal ([0023]).
Regarding claim 43, Zhang describes wherein the apparatus includes a means for generating a cancellation signal to at least partially cancel the signal in the implantable portion ([0023]).
Regarding claim 44, Zhang describes wherein the implantable portion of the hearing prosthesis includes a stimulation output device ([0081]), and the signal resulting from the external magnetic field originates at a location away from the stimulation output device ([0023], the signal resulting from the external magnetic field originates at an MRI machine, not the stimulation device).
Claims 11, 12, 15, 32, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Lin, further in view of Ball (US 2012/0219166 A1).
Regarding claims 11 and 12, Zhang in view of Lin suggests the apparatus of claim 9, but neither Zhang nor Lin explicitly disclose wherein the prosthesis includes an actuator that is configured to actuate to evoke a hearing percept and the prosthesis is configured to generate a low frequency, high amplitude signal or a high frequency, high amplitude signal so as to reduce and/or eliminate the hearing percept, which signal actuates the actuator of the prosthesis. However, Ball also describes a hearing prosthesis configured to generate interfering magnetic fields ([0009]), including the use of an actuator and electric leads extending from the actuator ([0005], drive coils within the floating mass transducer generate varying magnetic fields which, in turn, vibrate a magnetic mass suspended within the transducer). As Ball is also directed towards hearing prostheses and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate an actuator similar to that described by Ball when using the apparatus described by Zhang and Lin, as doing so advantageously allows the resulting apparatus to respond to the external magnetic field more efficiently. Specifically regarding the generation of a low frequency, high amplitude signal or a high frequency, high amplitude signal, the Examiner respectfully submits that, as the device resulting from an obvious combination of Zhang, Lin, and Ball generates signals in response to an external magnetic field, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to ensure that the resulting apparatus is capable of generating the signals recited by the claims, as doing so would be a matter of optimizing the prior art conditions via routine experimentation.
Regarding claim 15, Ball describes wherein the prosthesis includes an actuator ([0005]) and the prosthesis applies a current to the actuator to urge a moving part of the actuator to and/or towards a given location to reduce and/or eliminate the hearing percept ([0005]).
Regarding claim 32, Ball describes wherein the prosthesis includes an actuator that is configured to actuate to evoke a hearing percept ([0005]) and the prosthesis is configured to generate a signal so as to reduce and/or eliminate the hearing percept, which signal actuates the actuator of the prosthesis ([0005]).
Regarding claim 34, Zhang in view of Lin suggests the apparatus of claim 1, but neither Zhang nor Lin explicitly disclose wherein the implantable portion of the hearing prosthesis includes an actuator and electrical leads extending from the actuator and at least one of (a) the actuator is configured to actuate due to at least some varying magnetic fields in an overall magnetic field that has a value that is greater than at least 1.5T as a result of interaction of the magnetic field with the leads, or (b) the actuator is configured to actuate due to at least some varying magnetic fields having a gradient field value of 20 to 50 mT as a result of interaction of that magnetic field with the leads. However, Ball also describes a hearing prosthesis configured to generate interfering magnetic fields ([0009]), including the use of an actuator and electric leads extending from the actuator ([0005], drive coils within the floating mass transducer generate varying magnetic fields which, in turn, vibrate a magnetic mass suspended within the transducer). As Ball is also directed towards hearing prostheses and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate an actuator similar to that described by Ball when using the apparatus described by Zhang and Lin, as doing so advantageously allows the resulting apparatus to respond to the external magnetic field more efficiently. Specifically regarding the actuator being “configured to actuate due to at least some varying magnetic fields in an overall magnetic field that has a value that is greater than at least 1.5T as a result of interaction of the magnetic field with the leads,” the Examiner respectfully submits that, as it is well known that many MRI machines operate at 1.5T, it would have been obvious to the skilled artisan to ensure that the actuator responds to external magnetic fields at this field strength.
Claims 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Ball.
Regarding claim 17, Zhang describes an implantable prosthesis configured to provide a signal at a different frequency and/or amplitude relative to a phenomenon induced signal induced in the prosthesis that otherwise results in a respective actuation frequency and/or amplitude induced by a phenomenon unrelated to the prosthesis while the phenomenon is present, wherein the signal at the different frequency and/or amplitude at least partially mitigates the effects of the phenomenon induced signal ([0007]). Zhang does not explicitly disclose wherein implantable prosthesis is configured to provide a signal to an actuator of the prosthesis to actuate the actuator. However, Ball also describes an implantable prosthesis, including wherein the implantable prosthesis is configured to provide a signal to an actuator of the prosthesis to actuate the actuator ([0005]). As Ball is also directed towards an implantable prosthesis and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate an actuator similar to that described by Ball when using the apparatus described by Zhang, as doing so advantageously allows the resulting apparatus to respond to the external magnetic field more efficiently.
Regarding claim 18, Zhang describes wherein the phenomenon is a magnetic field of an MRI machine that generates at least a 1 T magnetic field ([0023]) and the prosthesis is configured to operate to accommodate the magnetic field gradient of the MRI field with respect to the influence thereof on the prosthesis, thereby at least partially mitigating the effects of the phenomenon induced signal ([0007]). Ball describes wherein the implantable prosthesis is a middle ear implant ([0009]).
Regarding claims 19 and 20, although neither Zhang nor Ball explicitly disclose the frequency of the actuator or the amplitude of the signal, the Examiner respectfully submits that, as the apparatus resulting from an obvious combination of Zhang and Ball contains an actuator and responds to external magnetic signals, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to ensure that the resulting apparatus is capable of operating at the frequencies recited and responding to the signals recited, as doing so would be a matter of optimizing the prior art conditions via routine experimentation.
Regarding claim 21, Ball describes wherein the implantable prosthesis is configured to provide an alternating signal to the actuator ([0005], the alternating signal being inherent in MRI applications). Zhang describes wherein the implantable prosthesis enables voltages induced via the phenomenon to be superimposed onto the alternating signal, thereby at least partially mitigating the effects of the phenomenon induced signal ([0023] - [0024]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Ball, further in view of Money (US 6,496,734 B1).
Regarding claim 23, Zhang in view of Ball suggests the apparatus of claim 17, but neither Zhang nor Ball explicitly disclose wherein the implantable prosthesis is configured to actuate to purposely trigger a stapedius reflex in a repeatable manner to at least partially mitigate the effects of the phenomenon induced signal. However, Money also describes an implantable prosthesis configured to partially mitigate the effects of a phenomenon induced signal (col 1:7-14), including wherein the implantable prosthesis is configured to actuate to purposely trigger a stapedius reflex in a repeatable manner to at least partially mitigate the effects of the phenomenon induced signal (col 1:66-2:30). As Money is also directed towards partially mitigating signals and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use the stapedius reflex, in a manner similar to that described by Money, when using the apparatus described by Zhang and Ball, as doing so advantageously allows the resulting apparatus to use a known physiological mechanism to assist in the signal mitigation.
Allowable Subject Matter
Claims 8, 16, 22, 38, 39, 41, and 42 are objected to as being dependent upon rejected base claims but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter.
Regarding claim 8, the prior art of record does not disclose or suggest generating the cancellation signal in the absence of the external magnetic field.
Regarding claim 16, the prior art of record does not disclose or suggest wherein the prosthesis is configured to saturate a middle ear of the recipient when functioning to reduce and/or eliminate the hearing percept. The Examiner notes that Applicant describes the saturation technique at least in paragraphs [0125] - [0126] of the published Specification.
Regarding claim 22, the prior art of record does not disclose or suggest dampening the phenomenon induced signal in the absence of external stimulus.
Regarding claim 38, the prior art of record does not disclose or suggest wherein the implantable portion of the hearing prosthesis is configured to stimulate tissue with the output component in the absence of the circuitry.
Claims 39 and 41 depend on claim 38 and contain at least the same allowable subject matter as claim 38.
Regarding claim 42, the prior art of record does not disclose or suggest the use of first, second, and third electrical signals configured as recited in the claim.
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Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel, can be reached by telephone at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796
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