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 .
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 4, 36-44, 48-51, 55, 64-67, 70 and 71 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith (US 2010/0198301).
Regarding claim 1, Smith discloses a method of at least partially fitting a hearing prosthesis device to a recipient (cochlear implant (hearing prosthesis device) is fitted to a recipient, Figs. 1-9), comprising: obtaining access to a sensory prosthesis that has been used to evoke a sensory percept using a first stimulation regime for a temporal period corresponding to at least acclimation to the first stimulation regime (cochlear implant system is initially set up with default electrode weights for each stimulation channel (interpreted to meet a first stimulation regime) and executes said stimulation regime for a temporal period, [0041]-[0045], the cochlear implant system is accessed after measurements are taken thus fulfilling “obtaining access to a sensory prosthesis that has been used to evoke a sensory percept using a first stimulation regime for a temporal period corresponding to at least acclimation to the first stimulation regime”); and adjusting a control setting of the prosthesis to increase current to and/or from certain electrode(s) relative to that which is the case with respect to the first stimulation regime, wherein the action of adjusting the control setting includes purposely adjusting the control setting to have stimulation that is effectively more diffuse than a minimum possible diffuseness (after measuring the results of the first stimulation regime, the fitting system 306 adjusts the weights for the probe channel to increase the focus of the channel or to decrease the focus of the channel depending on certain conditions, [0045]-[0052], thus the first stimulation regime is adjusted to have stimulation that is effectively more diffuse than a minimum possible diffuseness (it can be considered that decreasing the focus on the channel at various different weights would be more than a minimum possible diffuseness)).
Regarding claim 4, Smith discloses further comprising: fine tuning threshold and comfort levels for the adjusted control setting (fine tuning threshold and comfort levels for changed parameters set up by audiologist 304, [0037], [0078]).
Regarding claim 36, Smith discloses a system, comprising: a device configured to control stimulation to evoke a sensory percept via tissue stimulation of tissue of a recipient of the system (the fitting system 306 controls tissue stimulation by adjusts the weights for the probe channel to increase the focus of the channel or to decrease the focus of the channel depending on certain conditions, [0045]-[0052] which evokes a sensory percept in a recipient of the cochlear implant system [0041]-[0045]); and a device configured to enable the recipient to adjust the system so that the system stimulates the tissue in a different manner (user interface 930 allows a user to adjust the system so that the system stimulates the tissue in a different manner, Fig. 9, [0076]-[0079]).
Regarding claim 37, Smith discloses wherein: the adjustment adjusts a complexity of tissue stimulation of the system (adjustment adjusts a complexity of tissues stimulation by increasing or decreasing the magnitude of the neighboring electrodes of a tripolar system, [0022], [0056]).
Regarding claim 38, Smith discloses wherein: the adjustment increases and/or decreases a polarity of stimulation applied by the system (adjustment increases or decreases the magnitude of the neighboring electrodes of a tripolar system, which would effectively increase or decrease the polarity of stimulation applied by the system, [0022], [0056]).
Regarding claim 39, Smith discloses wherein: the system is configured to manage a risk of overstimulation of the recipient relative to that which would otherwise be the case (as the system is configured to adjust parameters based on a recipient’s comfort levels, the system is considered to be configured to manage a risk of overstimulation, [0037], [0078]).
Regarding claim 40, Smith discloses wherein: the adjustment is to focusing of the system with respect to tissue stimulation (stimulation adjustment results form focusing the system with respect to tissue stimulation via electrodes, [0065], [0066], [0073], [claim 4]); and the system is configured to enable the recipient to increase focusing in at least five different increments (stimulation weights correspond to the matrix of Fig. 8, which would lead to at least five different weights (increments), [0060]-[0062], with user interface 930 allowing a user to adjust the system so that the system stimulates the tissue in a different manner, Fig. 9, [0076]-[0079]).
Regarding claim 41, Smith discloses wherein: the device configured to control stimulation includes at least one hearing prosthesis map (individualized recipient map data 322, Fig. 3, [0035]); and the system is configured to at least one of operationally adjust the map or operationally replace the map with a new map to adjust focusing of the stimulation of the tissue (system is configured to at least adjust the map to adjust focusing of the stimulation of the tissue, Fig. 3, [0035], [0079], [0080]).
Regarding claim 42, Smith discloses wherein: the system is configured to store one or more previous maps and/or preadjusted maps having a lower level of tissue stimulation focusing relative to the adjusted / replacement maps (system is configured to store map data 322, Fig. 3, [0035], as the system is designed to increase focus, the preadjusted maps would have a lower level of tissue stimulations relative to the adjusted maps, [0065], [0079], [0080]); and the system is configured to enable reversion to the stored one or more previous maps and/or preadjusted maps for at least temporary use and/or testing purposes (system enables reverting to previously stored maps, Fig. 3, [0035], [0080]).
Regarding claim 43, Smith discloses a non-transitory computer-readable media having recorded thereon, a computer program for executing at least a portion of a method of fitting a sensory prosthesis to a recipient (computer readable medium for executing at least a portion of a method of fitting a sensory prosthesis to a recipient, Fig. 3, [0008], [0035], [0081]), the computer program including: code for enabling recipient controlled gradual transitioning from different stimulation modes (user interface 930/932 allows a user to control stimulation modes and code from the system allows gradual transitioning from different stimulation modes via eased in methods of stimulation (monopolar, bipolar, tripolar, and phased-array stimulation with the adjustment of numerous electrodes with weighted adjustment of -0.3 or -0.4 being considered a gradual change, with step size change being configured to be reduceable), [0033], [0034], [0039], [0040], [0056], [0057], [0069]).
Regarding claim 44, Smith discloses wherein: the gradual transitioning is from less focused tripolar stimulation to more focused tripolar stimulation (system can increase focus of tripolar stimulation, [0056], [0057]).
Regarding claim 48, Smith discloses further comprising: code for obtaining data indicative of recipient perceptions for respective stimulation modes (system 306 may obtain data indicative of recipient perceptions of stimulation modes (recipient indicate that they hear the probe channel), [0048], [0074], [0078]).
Regarding claim 49, Smith discloses further comprising: code for limiting transitioning from different stimulation modes based on a quantifiable change resulting from a single change (the stimulation modes have limited transitioning as a result of having quantifiable changes resulting from a single change, [0056], [0057], [0069], [0079], [0080]).
Regarding claim 50, Smith discloses further comprising: code for adjusting stimulation intensity levels based on input from the recipient for given stimulation modes (recipient indicates if they can hear the probe channel, which the audiologist then adjusts the stimulation levels based on the recipient input, [0048], [0074]).
Regarding claim 51, Smith discloses wherein: the sensory prosthesis is a cochlear implant (sensory prosthesis is a cochlear implant, Figs. 1-9, [0025]).
Regarding claim 55, Smith discloses wherein: the stimulation that is effectively more diffuse than the minimum possible diffuseness is less diffuse than that which was the case for the first stimulation regime (after measuring the results of the first stimulation regime, the fitting system 306 adjusts the weights for the probe channel to increase the focus of the channel or to decrease the focus of the channel depending on certain conditions, [0045]-[0052], thus the first stimulation regime is adjusted to have stimulation that is effectively more diffuse than a minimum possible diffuseness (it can be considered that decreasing the focus on the channel at various different weights would be more than a minimum possible diffuseness), since the system can adjust stimulation to increase focus, the stimulation would be less diffuse than that of the first stimulation regime, [0065]).
Regarding claim 64, Smith discloses a method of operating a stimulating medical device, comprising: obtaining access to the medical device, wherein the medical device has been used to stimulate tissue during a first temporal period (cochlear implant system is initially set up with default electrode weights for each stimulation channel (interpreted to meet a first stimulation regime) and executes said stimulation regime for a temporal period, [0041]-[0045], the cochlear implant system is accessed after measurements are taken thus fulfilling “obtaining access to a sensory prosthesis that has been used to evoke a sensory percept using a first stimulation regime for a temporal period corresponding to at least acclimation to the first stimulation regime”); and changing weights of stimulation channels of the medical device from that which was used during the first temporal period, wherein the action of changing the weights includes purposely changing the weights so that resulting stimulation using those weights changes a focusing of the stimulation (after measuring the results during the first temporal period, the fitting system 306 adjusts the weights for the probe channel to increase the focus of the channel or to decrease the focus of the channel depending on certain conditions, [0045]-[0052], [0056], [0057], [0065]).
Regarding claim 65, Smith discloses wherein: the medical device has an electrode array that is used to stimulate tissue (methods of stimulation can include monopolar, bipolar, tripolar, and phased-array stimulation with the adjustment of numerous electrodes with weighted adjustment of -0.3 or -0.4, etc., [0033], [0034], [0039], [0040], [0056], [0057], [0069]); and the resulting change in weights produces an asymmetrical stimulation pattern along the electrode array (since the weights of each electrode can be individually adjusted the resulting change in weights would produce an asymmetrical stimulation pattern along the electrode array, [0033], [0034], [0039], [0040], [0056], [0057], [0069]).
Regarding claim 66, Smith discloses wherein: relative weights of various stimulation channels changed in the action of changing the weights are different (relative weights of various stimulation channels changed in the action of changing the weights are different (electrodes are individually weighted and adjusted, [0033], [0034], [0039], [0040], [0056], [0057], [0069]).
Regarding claim 67, Smith discloses wherein: a weight of a first stimulation channel is higher than a weight of a second stimulation channel (first neighboring electrodes given a weight of -0.3 which is higher than the weight of extra-cochlea electrode (second stimulation channel with a weight of -0.4), [0056]); and a third stimulation channel immediately next to the first stimulation channel and the second stimulation channel vis-a-vis location along the electrode array has a weight that is different from the weight of the first stimulation channel and the weight of the second stimulation channel (central electrode (third stimulation channel) is next to the first and second stimulation channels and has a weight that is different from both of them +1.0, [0056]).
Regarding claim 70, Smith discloses further comprising: fine tuning threshold and comfort levels for the changed weights where the action of fine medical professional (fine tuning threshold and comfort levels for changed parameters set up by audiologist 304, [0037], [0078]).
Regarding claim 71, Smith discloses wherein: the medical device is a cochlear implant having a plurality of intra-cochlear electrodes (medical device is a cochlear implant having a plurality of intra-cochlear electrodes, [0004]); and the method is a method of gradually transitioning to focused multipolar stimulation from more simple stimulation regimes (method of gradually transitioning to focused multipolar stimulation from more simple stimulation regimes (going from monopolar to bipolar to tripolar or to more complex stimulation methods), [0033], [0034], [0039], [0040], [0056], [0057], [0069]).
Claim(s) 56-59 and 63 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lievans et al. (US 2014/0275730) herein Lievans.
Regarding claim 56, Lievans discloses a device (hearing prosthesis system 20, Fig. 1), comprising: an electrical stimulation apparatus configured to electrically stimulate tissue of a recipient of the device (bimodal hearing prosthesis 22 with stimulation electronics 30/32 configured to electrically stimulate tissue of a recipient, [0026], [0028], [0029]); and an apparatus configured to enable the recipient to vary focusing of the device with respect to tissue stimulation (user can adjust one or more electrical stimulation controls to modify the electrical stimulation parameters, [0051], user can be hearing prosthesis recipient, [0022]), wherein the device is a medical device (hearing prosthesis system 20 is a medical device, Fig. 1).
Regarding claim 57, Lievans discloses wherein: the device is an implantable medical device and/or a prosthetic device (hearing prosthesis 22 can be a cochlear implant or other implant, [0009]).
Regarding claim 58, Lievans discloses wherein: the device is a prosthetic device (hearing prosthesis 22 is a prosthetic device, [0009]).
Regarding claim 59, Lievans discloses wherein: the device is configured to evoke a sensory percept in the recipient (device is configured to evoke a sensory percept in the recipient, [0024]).
Regrading claim 63, Lievans discloses wherein: the device is a non-sensory percept evoking device (device 20 could be a computing device 44/220 which is a non-sensory percept evoking device, Figs. 1, 4, [0040], [0053]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 45, 47, and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2010/0198301) in view of Lievans et al. (US 2014/0275730) herein Lievans.
Regarding claim 45, while Smith does not specifically teach wherein: the code for enabling the recipient-controlled transitioning is code for self-fitting of the prosthesis to the recipient; and the code for self-fitting includes code for adjusting stimulation magnitudes of channels after transitioning into a stimulation mode of the different stimulation modes, Smith does teach code for allowing fitting of the prosthesis to the recipient (code for allowing fitting via fitting system 306, Smith: [0008], [0035], [0040], [0041], [0081], [0082]); and the code for fitting includes code for adjusting stimulation magnitudes of channels after transitioning into a stimulation mode of the different stimulation modes (user interface 930/932 allows a user to control stimulation modes and code from the system allows transitioning from different stimulation modes via eased in methods of stimulation (monopolar, bipolar, tripolar, and phased-array stimulation with the adjustment of numerous electrodes with weighted adjustment of -0.3 or -0.4), Smith: [0033], [0034], [0039], [0040], [0056], [0057], [0069]) and it is well known in the art to allow self-fitting by a recipient as demonstrated by Lievans (user can adjust one or more electrical stimulation controls to modify the electrical stimulation parameters, Lievans: [0051], and user can be the hearing prosthesis recipient, [0022]).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the code of Smith to allow self-fitting by a recipient as demonstrated by Lievans in order to give a user more control over their hearing experience.
Regarding claim 47, while Smith does not specifically teach further comprising: code for enabling recipient adjustment of a map and/or recipient development of a new map for respective stimulation mode settings of the prosthesis, Smith does teach code for enabling user adjustment of a map and/or recipient development of a new map for respective stimulation mode settings of the prosthesis (system is configured to at least adjust the map to adjust focusing of the stimulation of the tissue, (user interface 930/932 allows a user to control stimulation modes and mapping, Smith: Fig. 3, [0035], [0079], [0080]), and it is well known in the art to enable a recipient control over prosthesis settings as demonstrated by Lievans (user can adjust one or more electrical stimulation controls to modify the electrical stimulation parameters, Lievans: [0051], and user can be the hearing prosthesis recipient, [0022]).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the code of Smith to allow adjustment by a recipient as demonstrated by Lievans in order to give a user more control over their hearing experience.
Regarding claim 69, while Smith does not specifically teach wherein: the action of changing weights is executed by a recipient of the medical device, it is well known in the art to have a recipient able to change the parameter and weights of their hearing prosthesis as demonstrated by Lievans (user can adjust one or more electrical stimulation controls to modify the electrical stimulation parameters (weights), Lievans: [0051], and user can be the hearing prosthesis recipient, [0022]).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Smith to allow adjustment by a recipient as demonstrated by Lievans in order to give a user more control over their hearing experience.
Claim(s) 61 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Lievans et al. (US 2014/0275730) herein Lievans in view of Smith (US 2010/0198301).
Regarding claim 61, Lievans discloses wherein: the device is configured to enable the recipient to increase tissue stimulation (device has user interface which allows a user to control the stimulation parameters, [0022], [0023], [0024], [0051]), but lacks having focusing in at least twenty different increments.
Nevertheless, having numerous stimulation increments of at least twenty is well known in the art as demonstrated by Smith (Smith teaches the use of 22 electrodes with each being individually controlled, thus there must be at least 22 different increments, Smith: Fig. 8, [0060], [0061]).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Lievans to further allow focusing in at least twenty different increments as demonstrated by Smith in order to provide the user with increased control over the adjustment of tissue stimulation.
Regarding claim 62, while Lievans does not specifically teach wherein: the device is configured to enable the recipient to increase focusing of tripolar stimulation from a lower level of tripolar stimulation focusing to a higher level of such, it is well known in the tissue stimulation art to have an increased focusing of tripolar stimulation from a lower level of tripolar stimulation focusing to a higher level of such as demonstrated by Smith (system can increase focus of tripolar stimulation, Smith: [0056], [0057]).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the recipient controlled device of Lievans to be able to increase focusing of tripolar stimulation from a lower level of tripolar stimulation focusing to a higher level of such as demonstrated by Smith in order to provide a user more control of tissue stimulation utilizing well known stimulation methods.
Allowable Subject Matter
Claims 46, 52-54, 60 and 68 are 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.
Conclusion
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/SEAN H NGUYEN/Primary Examiner, Art Unit 2691