DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments and amendments filed 12/16/2025 have been fully considered but they are not persuasive.
Regarding the 35 USC 101 rejection, Applicant argues the limitation of “modify the current map based on the quality of stimulation” is “not an observation, evaluation, judgment o opinion that can be performed in the human mind with the assistance of pen and paper. In other words, a human mind cannot modify one or more operating parameters of a medical device based on a quality of stimulation.” The Examiner respectfully disagrees. As noted in the rejection dated 9/30/2025, the steps of “modify[ing] the current map based on the quality of stimulation”; and “determine[ing] a difference between the modified current map and a target map” are mental processes that, given their broadest reasonable interpretation, are evaluation steps performable in the human mind. For instance, these steps could encompass a clinician considering a patient response; making mental modifications to or pen and paper notes regarding changes to a therapy parameter list ; comparing this parameter list to a target list; and, when the difference does not satisfy a criteria, indicate further changes or issue a verbal alert.
Regarding step 2A Prong 2, Applicant argues the limitations of "a medical device configured to provide stimulation to a recipient to cause percepts based on a current map that comprises one or more operating parameters of the medical device," "modify the current map based on the quality of stimulation" and "responsive to the difference failing to satisfy a threshold, generate a clinician event that includes sending a notification to a computing device" reflect the improvement described in paragraph [0037] of the specification, which includes improving the performance of a sensory prosthesis based on fitting the sensory prosthesis and generating one or more clinician events. The Examiner respectfully disagrees. As noted in the rejection dated 9/30/2025, the medical device amounts to generally linking the abstract idea to another technological environment or field of use. The initial provision of stimulation amounts to insignificant extra-solution activity as the therapy is performed in order to gather data for the mental analysis steps (see MPEP §2106.04(d)(2)(c). The processor amount to generic computer structure for generic computer implementation of the abstract idea. Lastly, receiving data form the recipient of stimulation is insignificant extra-solution activity (mere data gathering). The step of “modify the current map based on the quality of stimulation” only requires determining new values for stimulation parameters and does not require any actual application of these values in a subsequent stimulation. These values are never applied and the claim ends with reporting the results of the comparison via some form of alert. Therefore, there aren’t any limitations currently present that would be commensurate in scope with improving performance of a sensory prosthesis as argued because the performance of the prosthesis is never adjusted within the scope of the claim. The Examiner suggests amending the claim to require the actual application of the new parameters to a user in order to overcome the current rejection. As the claims currently stand, the end result of the process is reporting the results of the difference between a modified current map and a target map. This is insignificant extra-solution activity of data display or reporting. The same arguments hold true for the Step 2B analysis when considering the limitations as a whole. The rejection is maintained.
Applicant’s arguments regarding the Li reference have been considered and are not persuasive. Li discloses generating a clinician alert when a change needs to be made (the fit does not meet a threshold criteria). See par. [0057] which illustrates how a clinician is notified of a direction of map change that is needed to satisfy a threshold criteria, “The fitting audiologist and/or the patient may also get an indication in a fitting dialogue about the direction of map change that provides a higher similarity index for the models used. For example, tilting a map −5% towards lower frequency may give a higher similarity index. “
Applicant’s arguments regarding Lineaweaver have been considered and are not persuasive. Lineaweaver discloses providing visual indications to a clinician during the fitting algorithm to show the evolution of the parameters over the process in order to allow the clinician to anticipate more efficient paths to an optimal setting (par. [0123]).
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 11-20, 26-32 and 36-38 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims are drawn to a product (Claims 11-20) and a process (claims 26-35)
Step 2A, Prong 1
Claims 11 and 26 recite “modify[ing] the current map based on the quality of stimulation”; and “determine[ing] a difference between the modified current map and a target map”;. These steps, given their broadest, reasonable interpretation amounts to a clinician considering a patient response; making mental modifications to or pen and paper notes regarding changes to a therapy parameter list ; comparing this parameter list to a target list to see if a threshold is met.
Step 2A, Prong 2
The claims do not include any additional elements that amount to integration of the abstract idea into a practical application.
Claim 11 includes the additional elements of “a medical device configured to provide stimulation to a recipient to cause precepts based on a current map that comprises one or more operating parameters of the medical device”; “one or more processors”; “reciev[ing] and indication from the recipient regarding the quality of stimulation”; and “generate a clinician event that includes sending a notification to a computing device”. The medical device amounts to generally linking the abstract idea to another technological environment or field of use. The initial provision of stimulation amounts to insignificant extra-solution activity as the therapy is performed in order to gather data for the mental analysis steps (see MPEP §2106.04(d)(2)(c). The processor amount to generic computer structure for generic computer implementation of the abstract idea. Receiving data form the recipient of stimulation is insignificant extra-solution activity (mere data gathering). Lastly, the sending of a notification is insignificant extra-solution activity in the form of data display or reporting.
Claim 26 includes the additional elements of “providing, via a medical device, stimulation to a recipient to cause precepts based on a current map”; “receiving and indication from the recipient regarding the quality of stimulation”; and “generating a clinician event that includes sending a notification to a computing device”. The medical device amounts to generally linking the abstract idea to another technological environment or field of use. The initial provision of stimulation amounts to insignificant extra-solution activity as the therapy is performed in order to gather data for the mental analysis steps (see MPEP §2106.04(d)(2)(c). Receiving data form the recipient of stimulation is insignificant extra-solution activity (mere data gathering). Lastly, the sending of a notification is insignificant extra-solution activity in the form of data display or reporting.
Generically linking the abstract idea to another technological environment or field of use; insignificant extra-solution activity and generic computer implementation do not amount to integration of the abstract idea into a practical application.
Step 2B
The claims do not include any additional elements that amount, alone or in combination, to significantly more than the abstract idea itself.
Claim 11 includes the additional elements of “a medical device configured to provide stimulation to a recipient to cause precepts based on a current map”; “one or more processors” “reciev[ing] and indication from the recipient regarding the quality of stimulation”; and “generate a clinician event that includes sending a notification to a computing device”. The medical device amounts to generally linking the abstract idea to another technological environment or field of use. The initial provision of stimulation amounts to insignificant extra-solution activity as the therapy is performed in order to gather data for the mental analysis steps (see MPEP §2106.04(d)(2)(c). The processor amount to generic computer structure for generic computer implementation of the abstract idea. Receiving data form the recipient of stimulation is insignificant extra-solution activity (mere data gathering). Lastly, the sending of a notification is insignificant extra-solution activity in the form of data display or reporting.
Generically linking the abstract idea to another technological environment or field of use; insignificant extra-solution activity and generic computer implementation do not amount, alone or in combination, significantly more than the abstract idea itself.
Claim 26 includes the additional elements of “providing, via a medical device, stimulation to a recipient to cause precepts based on a current map”; “receiving and indication from the recipient regarding the quality of stimulation”; and “generating a clinician event that includes sending a notification to a computing device”. The medical device amounts to generally linking the abstract idea to another technological environment or field of use. The initial provision of stimulation amounts to insignificant extra-solution activity as the therapy is performed in order to gather data for the mental analysis steps (see MPEP §2106.04(d)(2)(c). Receiving data form the recipient of stimulation is insignificant extra-solution activity (mere data gathering). Lastly, the sending of a notification is insignificant extra-solution activity in the form of data display or reporting.
Claims 12, 13, 16, 18, 27, 28, 30, 32 and 36 only further define the abstract idea.
Claims 14, 15, 17, 19, 29 and 31only further defines the data gathering steps and generic computer structure
Claims 20, 37 and 38 only generically link the abstract idea to another technological environment or field of use.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 11, 12, 20, 26 and 36-38 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Li et al. (2019/0151661).
Regarding Claims 11, 20 and 26, Li discloses a cochlear implant for providing electrical stimulation to a patient to cause hearing precepts and generating a preliminary fit map (e.g. a current map), see Abstract and par. [0051]. Li further discloses obtaining subjective feedback from a user (par. [0043, 0055]) regarding quality of stimulation. Li discloses that adjustments to the map can be made to produce a plurality of adjusted maps (par. [0055-0056]). These maps are compare to a target map and the map with the highest correlation to the target is selected. Li discloses generating a clinician alert when a change needs to be made (the fit does not meet a threshold criteria). See par. [0057] which illustrates how a clinician is notified of a direction of map change that is needed to satisfy a threshold criteria, “The fitting audiologist and/or the patient may also get an indication in a fitting dialogue about the direction of map change that provides a higher similarity index for the models used. For example, tilting a map −5% towards lower frequency may give a higher similarity index.”
In regard to Claims 12 and 36, Li discloses that the map can be further adjusted to tilt a map in response to a similarity index not being high enough (quality is too low), see par. [0057]).
Regarding Claims 37 and 38, Li discloses the process can be handled via a remote server or a local device (par. [0058]).
Claims 11-16, 19, 20, 26-30 and 36-38 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Lineaweaver et al. (2010/0152813).
Regarding Claims 11, 20 and 26, Lineaweaver discloses a cochlear implant system configured to provide sound percepts to a user; system having one or more processors 1212 (Fig. 12) that performs an iterative process of generating an initial MAP that defines a set of stimulation parameters and obtaining patient feedback regarding the quality of the MAP (par. [0086]). The MAP can then be adjusted (mutated) and compared to a target MAP (a fitness function). If the comparison fails to satisfy a threshold (such as failing to fall below a diversity limit), a clinician event is generated, such as continuing the fitting process (par. [0098-0099]). Lineaweaver further discloses providing visual indications to a clinician during the fitting algorithm to show the evolution of the parameters over the process in order to allow the clinician to anticipate more efficient paths to an optimal setting (par. [0123]). The process only continues as the fit does not meet a threshold so the visual indications are in response to the fit not meeting a threshold.
In regards to Claims 12, 13, 27, 28 and 36, Lineaweaver discloses that if the MAP is not possible/feasible (thus falling outside of acceptable limits, e.g. floors, ceilings), the MAP is returned to the genetic algorithm, which can be considered a clinician event (par. [0105]).
Regarding Claims 14, 15, 19 and 29, Lineaweaver discloses a user interface 1214 (a recipient computing device) that is coupled to the system (Fig. 12) that allows for querying the recipient regarding stimulation and allowing the recipient to input a response to the querying (par. [0148, 0156]; Fig. 12, 14).
In regard to Claims 16 and 30, Lineaweaver discloses modifying a MAP based on user responses (selecting MAPS used in the mutation process of the genetic algorithm based on user input, see par. [0086]).
Regarding Claims 37 and 38, Lineaweaver discloses utilizing a personal digital assistant or smart phone (which can be interpreted as a local computing device) or a personal computer (which can be considered a remote computing device), see par. [0189].
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.
Claims 17 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Lineaweaver et al. (2010/0152813) in view of Lievens et al. (2014/0275730). Lineaweaver discloses a user interface that allows user control /selection of parameters but fails to discloses loudness indicators on the UI. However, Lievens discloses buttons (physical or on a touch screen) that allow a user to adjust volume (which would be an indication that stimulation is too high or low) for the purpose of allowing fine tune control of a stimulation regimen (par. [0042]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Lineaweaver reference to include buttons indicative of stimulation being too high or too low, as taught and suggested by Lievens, for the purpose of allowing fine tune control of a stimulation regimen.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796