DETAILED ACTION
The office action is in response to original application filed on 11-22-24. Claims 1-4, 6-7, 9, 11-17, 21-25 and 27-28 are pending in the application and have been examined.
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 statements (IDS) submitted filed before the mailing of a first Office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97(b) (3). Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-3, 9, 11-15, 17 and 21 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by US 2013/0109909 to Van Gerwen (“Van”).
Regarding claim 1, Van discloses an external component of a prosthesis (fig. 1A, 101) configured to provide power to an implanted device (175) implanted in a human ([0027]), wherein the external component is configured so that a level of power output ([0036]) to the implanted device is dynamically varied, based on data that is based on a load of the implanted device ([0036], with audio data is received for a predetermined period of time, the internal portion 175 may go in to sound awareness mode), in a digital binary manner ([0037] and [0024], the output of the transducer 102 and may generate coded signals which are provided to the external coil 108).
Regarding claim 2, Van discloses the external component is configured to dynamically vary the level of power output ([0025]) to the implanted device in the digital binary matter ([0037] and [0024], the output of the transducer 102 and may generate coded signals which are provided to the external coil 108) irrespective of the load of the implant (external portion 150 is coupled to the internal portion 175 via an inductive coupling pathway 125).
Regarding claim 3, Van discloses the digital binary manner ([0037] and [0024], the output of the transducer 102 and may generate coded signals which are provided to the external coil 108) comprises a maximum power output and a lowest level power output ([0025]).
Regarding claim 9, Van discloses the device is a cochlear implant (fig. 1, cochlear implant).
Regarding claim 11, Van discloses an external component of a prosthesis (fig. 1A, 101) configured to provide power to an implanted device (175) implanted in a human ([0027]), wherein the external component is configured so that a principal power ([0025], external portion 150 may be able to inductively charge the power source within the internal portion 175. A power source that is part of the external portion 150 is the primary power source for the hearing prosthesis) varying regime is based on varying power output to the implanted device by varying lengths of temporal periods of continuous maximum power output ([0036], For example, during operation of the hearing prosthesis, a "keep alive" signal is transmitted to ensure the internal portion 175 stays powered on).
Regarding claim 12, Van discloses the principal power varying regime further includes varying lengths of temporal periods ([0036], If no "keep alive" is received for a predetermined period of time, the internal portion 175 may go in to sound awareness mode) of minimum power output ([0025], external portion 150 may be able to inductively charge the power source within the internal portion 175. A power source that is part of the external portion 150 is the primary power source for the hearing prosthesis).
Regarding claim 13, Van discloses the principal power varying regime has respective periods of minimum power output interleaved with respective periods of maximum power output ([0036], For example, during operation of the hearing prosthesis, a "keep alive" signal is transmitted to ensure the internal portion 175 stays powered on).
Regarding claim 14, Van discloses the principal power varying regime increases power to the maximum power output in an effectively rampless manner ([0036], For example, during operation of the hearing prosthesis, a "keep alive" signal is transmitted to ensure the internal portion 175 stays powered on).
Regarding claim 15, Van discloses the principal power varying regime varies power output in an effectively rampless manner ([0036], For example, during operation of the hearing prosthesis, a "keep alive" signal is transmitted to ensure the internal portion 175 stays powered on).
Regarding claim 17, Van discloses the external component is configured to vary power output in the principal power regime based on data that is based on power load of the implanted device ([0036], the sensor may sense a signal from the external portion 150 that contains acoustic information).
Regarding claim 21, Van discloses automatically obtaining data ([0036-0041) based on data that is influenced by load on a power consuming (0025], with the implanted internal coil 158 inside the recipient's head. The internal coil 158 receives power and data from the external coil 108) implanted medical device implanted in a human ([0027]); automatically analyzing the obtained data; and transcutaneously providing power to the implanted medical device by increasing power to the implant to a maximum amount from a minimum amount ([0042], level sets the maximal allowable stimulation level for each electrode channel. For a cochlear implant, the comfort level corresponds to the maximum stimulation current level that feels comfortable to the recipient) or decreasing power to the implant to the minimum amount from the maximum amount depending on the result of the analysis.
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.
Claims 4, 6, 22-25 and 27 are rejected under 35 U.S.C. 103 (a) as being unpatentable over US 2013/0109909 to Van Gerwen (“Van”).
Regarding claim 4, Van discloses the digital binary manner ([0037] and [0024], the output of the transducer 102 and may generate coded signals which are provided to the external coil 108), the maximum possible power output being a power output ([0042], The comfort level sets the maximal allowable stimulation level for each electrode channel. For a cochlear implant, the comfort level corresponds to the maximum stimulation current level that feels comfortable to the recipient) obtainable if control componentry of the external component that enable the digital binary mannered ([0037] and [0024], the output of the transducer 102 and may generate coded signals which are provided to the external coil 108) dynamic variation of power output level was eliminated.
Van does not disclose “a first output level which is at or above 80% of a maximum possible power output of the external component and a second output level which is at or below 60% of the maximum possible power output of the external component”. However, Van does disclose the comfort level sets the maximal allowable stimulation level for each electrode channel. For a cochlear implant, the comfort level corresponds to the maximum stimulation current level and the comfort levels may affect how speech sounds to the recipient more than the threshold output levels because most of the acoustic speech signal may generally be mapped onto approximately the top 20% of the threshold output level and comfort level range ([0042]). It has previously been held that “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”. See MPEP 2144.05.I. It has further been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP 2144.05.II.A. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the application to have provided the comfort levels may affect how speech sounds to the recipient more than the threshold output levels because most of the acoustic speech signal may generally be mapped onto approximately the top 20% of the threshold output level and comfort level range, and/or as the mere discovery or optimum or workable ranges by routine experimentation within prior art conditions.
Regarding claim 6, Van discloses all the claim limitation as set forth in the rejection of claims above.
Van does not disclose “the external component is configured to effectively immediately increase an output power level by at least 60% and effectively immediately decrease the output power level by at least 35%”. However, Van does disclose the comfort level sets the maximal allowable stimulation level for each electrode channel. For a cochlear implant, the comfort level corresponds to the maximum stimulation current level and the comfort levels may affect how speech sounds to the recipient more than the threshold output levels because most of the acoustic speech signal may generally be mapped onto approximately the top 20% of the threshold output level and comfort level range ([0042]). It has previously been held that “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”. See MPEP 2144.05.I. It has further been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP 2144.05.II.A. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the application to have provided the comfort levels may affect how speech sounds to the recipient more than the threshold output levels because most of the acoustic speech signal may generally be mapped onto approximately the top 20% of the threshold output level and comfort level range, and/or as the mere discovery or optimum or workable ranges by routine experimentation within prior art conditions.
Regarding claim 22, Van discloses the claimed invention except for “within a period of 1 minute, the actions of automatically obtaining and analyzing are executed ten times, and ten results of the analysis of the obtained data is that an increase in a power level transcutaneously provided to the implanted medical device is needed; and respective increases in the power level transcutaneously provided to the implanted medical device increase by at least 50% within 5 milliseconds.”.
One of ordinary skill in the art prior to the effective filing date would recognize that the particular period of analyzing data to adjust power in a given period of time used would depend on the desired the period to adjust power in a given period of time of the particular system/components used.
Since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 23, Van discloses prior to obtaining data based on data that is influenced by a power load ([0036]- [0042), except for “the implanted medical device experiences a beginning of a load transient that at least quadruples a load within 10 milliseconds, the obtained data being impacted by least a portion of the load transient, wherein the action of transcutaneous providing power provides sufficient power that within 10 milliseconds of the completion of the quadrupling of the load, a voltage of the implanted medical device is returned to a value that is within 5% of the value just before commencement of the load transient”.
One of ordinary skill in the art prior to the effective filing date would recognize that the particular load transient in milliseconds and percentage value of voltage used would depend on the desired load transient period and the required voltage value of the particular system/components used.
Since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 24, Van discloses the claimed invention, except for “within a period of 1 minute, during which the actions of automatically obtaining and analyzing is repeatedly executed, a load of the implanted medical device varies by at least 30% upwards and downwards at least 5 times; and a voltage of the implanted medical device does not deviate more than 25% from the highest voltage during the period of 1 minute”.
One of ordinary skill in the art prior to the effective filing date would recognize that the particular given period of time to analyzing data and percentage value of power requirement used would depend on the time period and the required power value of the particular system/components used.
Since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 25, Van discloses the claimed invention, except for “within a period of 1 minute, during which the actions of automatically obtaining and analyzing is repeatedly executed, a load of the implanted medical device varies by at least 30% upwards and downwards at least 5 times; and a voltage of the implanted medical device does not deviate more than 10% from the highest voltage during the period of 1 minute”.
One of ordinary skill in the art prior to the effective filing date would recognize that the particular given period of time to analyzing data and percentage value of power requirement used would depend on the time period analyzing data and the percentage of required power value of the particular system/components used.
Since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 27, Van discloses prior to obtaining data based on data that is influenced by a power load ([0036]- [0042), except for “the implanted medical device experiences a beginning of a load transient that at least quadruples a load within 10 milliseconds, the obtained data being impacted by least a portion of the load transient, wherein the action of transcutaneous providing power provides sufficient power that during the load transient, a voltage of the implanted medical device is not reduced by any more than 30% from the voltage of the implanted medical device just before the load transient.”.
One of ordinary skill in the art prior to the effective filing date would recognize that the particular given period of time to load transient and percentage value of voltage requirement used would depend on period of time to load transient and the percentage of required voltage value of the particular system/components used.
Since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claims 7 is rejected under 35 U.S.C. 103 (a) as being unpatentable over US 2013/0109909 to van Gerwen (“Van”) in view of US 2022/0257923 to Roe et al.(“Roe”).
Regarding claim 7, Van discloses the external component includes an inductance power transfer coil (fig. 3, 108); and in the digital binary manner ([0037] and [0024], the output of the transducer 102 and may generate coded signals which are provided to the external coil 108).
But, Van does not disclose the external component is configured to digitally dynamically vary a duty cycle of engagement of the coil to dynamically vary the level of power output to the implanted device
However, Roe discloses the external component is configured to digitally dynamically vary a duty cycle (fig. 4, 102, controlling power by adjusting duty cycle) of engagement of the coil to dynamically vary the level of power output to the implanted device
Therefore, it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to modify Van by adding PWM Duty Cycle as part of its configuration as taught by Roe, in order to control the current in thee-coil via a driver such as an H-bridge.
Allowable Subject Matter
Claims 16 and 28 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 16 is objected to as being dependent upon a rejected base claim, 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 an examiner’s statement of reasons for the indication of allowable subject matter: Claim 16 indicated as containing allowable subject matter because prior art fails to teach or suggest, either alone or in combination all of the limitations of claim 16, especially the principal power varying regime varies a ratio of
respective temporal lengths of maximum power output to respective temporal lengths of minimum power output.
Claim 28 is objected to as being dependent upon a rejected base claim, 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 an examiner’s statement of reasons for the indication of allowable subject matter: Claim 28 indicated as containing allowable subject matter because prior art fails to teach or suggest, either alone or in combination all of the limitations of claim 28, especially the power consuming implanted medical device has a voltage operating range that has a lower limit above a reset voltage and an upper limit below a shunt voltage; prior to obtaining data based on data that is influenced by a power load,
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ackland et al. US 2023/0355972 Al- A method for the treatment of a patient suffering or recovering from a critical illness using a device comprising a generator configured to produce an electrical stimulation signal and a controller. The controller is connected to the generator and configured to determine the form of the electrical stimulation signal. The method includes producing an electrical stimulation signal from the generator, and determining the form of the electrical stimulation signal using the controller connected to the generator; and transmitting the electrical stimulation signal to an electrode in contact with a tragus of the patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESAYAS G YESHAW whose telephone number is (571)270-1959. The examiner can normally be reached Mon-Sat 9AM-7PM.
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, Menna Youssef can be reached at 5712703684. 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 (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ESAYAS G YESHAW/Examiner, Art Unit 2836
/Menatoallah Youssef/SPE, Art Unit 2836
Prosecution Insights