DETAILED ACTION
The Non-Final Office Action is in response to the original filed claims and specification [November 10, 2025].
Claims 1-2, 6, 9-10 are Originals.
Claims 3-5, 7 -8 are Amended.
Claims 1-10 are currently pending and have been considered below.
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 § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “best” in claims 5 and 10 are relative term which renders the claim indefinite. The term “best” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. These parameters “best possible repair approach and best hearing aid component” has been rendered indefinite. Appropriate correction is required.
Regarding claim 5, 6 and 10, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction is required.
Claim Rejections - 35 USC § 101, software per se
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.
Claim(s) 9 and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim(s) 9, as recited, is directed toward a system that has no tangible or physical form ( - a cloud-based database service and hearing aid repair facility computing system), the (physical components or form) are not explicitly disclosed in the specification to properly define the system. The specification merely re-recites the claim language. The drawing also does not remedy the deficiencies and is merely a flow chart.
Claim(s) 10, is dependent on claim 9 and inherits the deficiency therefore both claims are ineligible under 101.
The claims as written are directed to unpatentable subject matter, appropriate correction is required.
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Step 1 (The Statutory Categories): Is the claim to a process, machine, manufacture, or composition of matter? MPEP 2106.03.
Per Step 1, claim(s) 1-8 to a method (i.e., a process); Claims 9 and 10 are directed to a software.
Thus, the claims are directed to statutory categories of invention. However, the claims are rejected under 35 U.S.C. 101 because they are directed to an abstract idea, a judicial exception, without reciting additional elements that integrate the judicial exception into a practical application.
The analysis proceeds to Step 2A Prong One.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon? MPEP 2106.04.
The abstract idea of claim 1 is:
A method of repairing a hearing aid comprising the steps of:
- storing in a cloud-based database service, for each of a plurality of hearing aid users, a data set comprising a complete data image of a hearing aid setting;
- providing in a hearing aid repair facility a novel or refurbished hearing aid;
- granting said hearing aid repair facility access to at least a part of a specific hearing aid user's data set, wherein said part comprises the complete data image of a hearing aid setting for said specific hearing aid user;
- providing a replacement hearing aid by transferring at least said complete data image of the hearing aid setting for the specific hearing aid user to said novel or refurbished hearing aid; and
- delivering said replacement hearing aid from said hearing aid repair facility and to said specific hearing aid user's residence or mailing address.
The abstract idea of claim 9 is:
A hearing aid repair system comprising:
- a cloud-based database service holding for each of a plurality of hearing aid users, a data set comprising a complete data image of a hearing aid setting;
- a hearing aid repair facility computing system configured to:
- - enable access to said cloud-based database service and to retrieve a complete data image for a specific hearing aid user in response to a positive evaluation of access rights, and
- - use said complete data image to program a replacement hearing aid.
The abstract idea steps italicized above are those which could be performed mentally, including with pen and paper. The steps describe, at a high level, storing, providing, granting and delivering hearing aid from a hearing facility. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, including observations, evaluations, judgements, and/or opinions, then it falls within the Mental Processes – Concepts Performed in the Human Mind grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Additionally, and alternatively, the abstract idea steps italicized above relate to providing, granting, delivering replacement hearing aid and enabling access to cloud-based database service and retrieving data image for a specific hearing aid user, these constitutes a process that, under its broadest reasonable interpretation, covers managing personal behavior relationships, interactions between people. This is further supported by Page 2, third sentence of applicant’s specification as filed. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior relationships, interactions between people, including social activities, teaching, and/or following rules or instructions, then it falls within the Certain Methods of Organizing Human Activity – Managing Personal Behavior Relationships, Interactions Between People grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? MPEP 2106.04.
This judicial exception is not integrated into a practical application because the additional elements are merely instructions to apply the abstract idea to a computer, as described in MPEP 2106.05(f) and MPEP 2106.05(h).
Claim 1 recites the following additional elements: Storing in a cloud-based database service, for each of a plurality of hearing aid users, a data set comprising a complete data image of a hearing aid setting; a hearing aid repair facility a novel or refurbished hearing aid; aid repair facility access to at least a part of a specific hearing aid user's data set, wherein said part comprises the complete data image of a hearing aid setting for said specific hearing aid user; hearing aid by transferring at least said complete data image of the hearing aid setting for the specific hearing aid user to said novel or refurbished hearing aid. These elements are merely instructions to apply the abstract idea to a computer, per MPEP 2106.05(f). Applicant has only described generic computing elements in their specification, as seen in [Page number 5, paragraph 5.] of applicant’s specification as filed, for example.
The Examiner interprets “for each of a plurality of hearing aid users, a data set comprising a complete data image of a hearing aid setting” and “granting said hearing aid repair facility access to at least a part of a specific hearing aid user's data set” described in [Page 5, paragraph 5] of applicant’s specification as generally linking to the field of use, per MPEP 2106.05(h).
Claim 9 recites the following additional elements: a cloud-based database service holding for each of a plurality of hearing aid users, a data set comprising a complete data image of a hearing aid setting; a hearing aid repair facility computing system configured to: cloud-based database service and to retrieve a complete data image for a specific hearing aid user use said complete data image to program a replacement hearing aid. These elements are merely instructions to apply the abstract idea to a computer, per MPEP 2106.05(f). Applicant has only described generic computing elements in their specification, as seen in [Page number 7, paragraph 1] of applicant’s specification as filed, for example.
The Examiner interprets “enable access to said cloud-based database service and to retrieve a complete data image for a specific hearing aid user in response to a positive evaluation of access rights” described in [Page 11] of specification as generally linking to the field of use, per MPEP 2106.05(h).
Further, the combination of these elements is nothing more than a generic computing system applied to the tasks of the abstract idea. Because the additional elements are merely instructions to apply the abstract idea to a generic computing system, they do not integrate the abstract idea into a practical application, when viewed in combination. See MPEP 2106.05(f) or Linking to the field of use. See MPEP 2106.05(h).
Therefore, per Step 2A Prong Two, the additional elements, alone and in combination, do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
Step 2B (The Inventive Concept): Does the claim recite additional elements that amount to significantly more than the judicial exception? MPEP 2106.05.
Step 2B involves evaluating the additional elements to determine whether they amount to significantly more than the judicial exception itself.
The examination process involves carrying over identification of the additional element(s) in the claim from Step 2A Prong Two and carrying over conclusions from Step 2A Prong Two pertaining to MPEP 2106.05(f).
The additional elements and their analysis are therefore carried over: applicant has merely recited elements that facilitate the tasks of the abstract idea, as described in MPEP 2106.05(f).
Further, the combination of these elements is nothing more than a generic computing system. When the claim elements above are considered, alone and in combination, they do not amount to significantly more.
Therefore, per Step 2B, the additional elements, alone and in combination, are not significantly more. The claims are not patent eligible.
The analysis takes into consideration all dependent claims as well:
Claims 2 recites additional abstract steps and/or information that narrow the abstract idea: specific hearing aid user and a hearing care professional to grant said hearing aid repair facility access to said at least part of a specific hearing aid user's data set, data image. Simply narrowing the abstract idea does not integrate it into practical application and/or add significantly more. Similar to above, these are steps of administrating care to an individual using generic computing elements that are merely facilitating the tasks of the narrowed abstract idea. Whether viewed alone or in combination with those additional elements highlighted previously, this does not integrate the abstract idea into practical application and/or add significantly more. See MPEP 2106.05(f).
Claims 3, 4, 7 and 8 recites additional abstract steps and/or information that narrow the abstract idea: a cloud-based database service, for each of a plurality of hearing aid users, a data set comprising a complete data image of a hearing aid setting. Simply narrowing the abstract idea does not integrate it into practical application and/or add significantly more. Similar to above, these are steps of administrating care to an individual using generic computing elements that are merely facilitating the tasks of the narrowed abstract idea. Whether viewed alone or in combination with those additional elements highlighted previously, this does not integrate the abstract idea into practical application and/or add significantly more. See MPEP 2106.05(f).
Claims 5, 6 and 10 recites additional abstract steps and/or information that narrow the abstract idea: cloud-based database service, neural network-based prediction model, vectors, a feedforward neural network. These elements are merely instructions to apply the abstract idea to a computer, per MPEP 2106.05(f). Applicant has only described generic computing elements in their specification, as seen in [Page 13-15] of applicant’s specification as filed, for example.
Accordingly, claims 1-10 are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
In conclusion the claims do not provide an inventive concept, because the claims do not recite additional elements or a combination of elements that amount to significantly more than the judicial exception of the claims. Therefore, whether taken individually or as an order combination, the claims are nonetheless rejected under 35 U.S.C. 101 as being directed to non - statutory subject matter.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4 and 7- 9 are rejected under 35 U.S.C. 103 as being unpatentable over Westergaard et al [US 2018/031,0104 A1], hereafter Westergaard; in view of Brumback et al [US 2005/022,2823 A1], hereafter Brumback, in further view of Manchester et al [US 2017/020,1839 A1], hereafter Manchester;
As per claim 1 and 9 (Similar Scope)
Westergaard discloses the automatic storage and retrieval of a personalized settings data for a hearing aid user in a master server; to preserve the settings if the hearing aid is lost, damaged or requires repair. See Westergaard [0052] - [0053]
A method of repairing a hearing aid comprising the steps of:
- storing in a [cloud-based database service], for each of a plurality of hearing aid users, a data set comprising a complete data image of a hearing aid setting;
{See Westergaard [0052] - [0053]}
Westergaard discloses the retrieval of a user’s audiogram from the database and uses it to program a personalized hearing aid setting, then stores the hearing aid unique identifier in the user’s cloud account. See [0058] of Westergaard.
- providing a replacement hearing aid by transferring at least said complete data image of the hearing aid setting for the specific hearing aid user to said novel or refurbished hearing aid; and
{[0058] In step 102, the computer 36 retrieves the audiogram from the user account in the master server 37, and in step 103, the set of hearing aids 1 is configured and personalized settings are programmed based on the audiogram. In step 104, the computer 36 retrieves the hearing aid ID from the hearing aid 1 and stores the Hearing aid ID in the user account in the master server 37. }
Westergaard discloses the system allowing an authorized hearing care professional or service provider to securely access the users data and using the stored user settings to deliver secure personalized services to the user; See paragraph [0046] and [0055];
- delivering said replacement hearing aid from said hearing aid repair facility and to said specific hearing aid user's residence or mailing address.
{[0046] A delivery address data field 52 defines the delivery address for hardware to be delivered to the hearing aid user…. The delivery address is specified by the owner of the account and may be identical to the home address identified in the personal information data field 51, may identify a preferred pick up place (e.g. a medical house) or may identify a preferred pick up place in case the account is linked to a membership in a warehouse club.
[0055] As a part of the programming the test and programming station 41 will retrieve the delivery address from the delivery address data field 52, and print a label based on the delivery address, and the least one personalized hearing aid 1 can be delivered to the address specified by the hearing aid user.}
Westergaard does not explicitly disclose the hearing aid repair facility, however Brumback discloses a centralized manufacturing of hearing aid devices with scanning and dispensing at the satellite offices, along with the methods for repairing or refurbishing existing hearing aid. See Brumback [0036] and [0040].
- providing in a hearing aid repair facility a novel or refurbished hearing aid;
{[0036] Manufacturing at Central Office; Scanning and Dispensing at Satellite Office;
[0040] Methods of Repairing Existing Ear Aid Devices.}
Westergaard discloses the hearing aid user can authorize designated hearing care professional or provider to securely access selected hearing aid data stored in a database, with the user retaining control over the access rights See Westergaard [0044], however does not disclose granting a repair facility an access to an external database; Brumback teaches a process a user ear impression is scanned at a satellite office, electronically transferred to a central office for CAD-based design. See Brumback [0037]
- granting said hearing aid repair facility access to at least a part of a specific hearing aid user's data set, wherein said part comprises the complete data image of a hearing aid setting for said specific hearing aid user;
{See Brumback [0037]}
Motivation: It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine/modify/adjust Westergaard’s System and method for personalizing a hearing aid to include Brumback et al’s centralized manufacturing of hearing aid devices, granting an access by the user and electronically transferring user’s information to the repair facility to enable a repair or refurbishment of the hearing aid. See Brumback [0037].
Westergaard does not explicitly disclose the cloud-based database service, however; Manchester teaches storing in a cloud-based database service; (Manchester discloses that the streaming server stores patient’s identification and patent current attributes setting data, while the conventional database server stores a patient’s historical settings, account information and scheduling details in a cloud; See Manchester [0026] and [0031]).
Motivation: It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine/modify/adjust Westergaard’s System and method for personalizing a hearing aid to include Manchester et al’s cloud-based database service to enable the storage of patient’s data. See Manchester [0026] and [0031].
As per claim 2;
Westergaard discloses a permission-based system where a hearing aid user can grant authorized hearing care professionals or service providers permission to securely access selected hearing-aid data stored in the cloud for providing personalized hearing care; See Westergaard paragraph [0044];
The method according to claim 1, comprising the step of: - enabling at least one of a specific hearing aid user and a hearing care professional to grant said hearing aid repair facility access to said at least part of a specific hearing aid user's data set, wherein said part comprises the complete data image of a hearing aid setting for said specific hearing aid user.
{[0044] Finally, authorized hearing healthcare professional or audiologists may from a computer 44 via an appropriate Internet connection access the master server 37 having user data storage 38 for maintaining and storing hearing aid user accounts. Accessing user data stored on the master server 37 requires that the authorized hearing healthcare professional has the appropriate access rights. The authorized hearing aid professionals have audiological test and fitting equipment 45 for measuring and estimating the hearing loss of the customer, and subsequently fitting a set of hearing aids 1 compensating for the unique hearing loss of the customer. According to one embodiment of the invention, an authorized hearing healthcare professional creates an audiogram based on his audiological tests and uploads the audiogram to the user account maintained by the master server 37, from where it is retrieved by the manufacturer for personalizing the requested set of hearing aids 1.}
As per claim 3;
The combination of Westergaard and Brumback does not explicitly discloses the following, however; Manchester discloses that the streaming server stores patient’s identification and patient current attributes setting data, while the authorized hearing professionals to access and modify the patients’ settings remotely; See Manchester [0016].
The method according to claim l, The method according to claim l wherein said step of storing in a cloud-based database service, for each of a plurality of hearing aid users, a data set comprising a complete data image of a hearing aid setting is carried out as part of the initial hearing aid fitting or is carried out at some point in time after the initial hearing aid fitting at the hearing aid user's discretion.
{[0016] The invention permits any hearing professional, including a newly employed hearing professional, to immediately access the most recent hearing aid settings of the patient and the patient's settings history and to do so with only the permission of the patient but without the necessity of participation by the patient in the transfer of the recent hearing aid settings and the settings history.
Motivation: It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine/modify/adjust the combination of Westergaard and Brumback’s System and method for personalizing a hearing aid to include Manchester et al’s cloud-based database service to enable the storage of patient’s data. See Manchester [0016].
Westergaard discloses the hearing aids are personalized at the manufacturing facility by uploading the users audiogram and performing an initial fitting, allowing skilled technicians using dedicated programming equipment to complete the first fitting step. See Westergaard
[0037] Hereby the hearing aids 1 become personalized prior to leaving the manufacturing facility; and the programming at the manufacturing facility becomes a first fitting step which takes place in a factory environment based on uploading of the audiogram of the and user. This is beneficial as the first fitting step takes place as part of a manufacturing facility environment where technicians in the manufacturing facility are expert in manipulating the hearing aids, and the test and programming jig 41 is dedicated for this sole purpose.
As per claim 4;
The combination of Westergaard and Manchester does not explicitly disclose the following, however; Brumback teaches a process users ear impression is scanned at a satellite office, electronically transferred to a central office for CAD-based design. See Brumback [0037]
The method according to claim l The method according to claim l wherein said step of: granting said hearing aid repair facility access to at least a part of a specific hearing aid user's data set, wherein said part comprises the complete data image of a hearing aid setting for said specific hearing aid user comprises the further steps of: - providing to the hearing aid repair facility a link to the cloud-based database service, and
{See Brumback [0037]}
Motivation: It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine/modify/adjust the combination of Westergaard and Manchester’s System and method for personalizing a hearing aid to include Brumback et al’s centralized manufacturing of hearing aid devices, granting an access by the user and electronically transferring user’s information to the repair facility to enable a repair or refurbishment of the hearing aid. See Brumback [0037].
Westergaard discloses authorized hearing healthcare professional with appropriate access rights upload a patients’ audiogram to a master server, where it is stored and later retrieved by the manufacturer to personalize the patient’s hearing aids; See [0044]
- authorizing the hearing aid repair facility to access said cloud-based database service and retrieve the data set of said specific hearing aid user.
[0044] Accessing user data stored on the master server 37 requires that the authorized hearing healthcare professional has the appropriate access rights. The authorized hearing aid professionals have audiological test and fitting equipment 45 for measuring and estimating the hearing loss of the customer, and subsequently fitting a set of hearing aids 1 compensating for the unique hearing loss of the customer. According to one embodiment of the invention, an authorized hearing healthcare professional creates an audiogram based on his audiological tests and uploads the audiogram to the user account maintained by the master server 37, from where it is retrieved by the manufacturer for personalizing the requested set of hearing aids 1.
The combination of Westergaard and Brumback does not explicitly disclose the following, however; Manchester discloses a communication streamed from the originating source to servers on the cloud. The servers’ stores patient’s data and historical settings.
[0026] Communication over the internet between the hearing professional's mobile device 22 at one location and the patient's hearing aid 12 and mobile device 14 at a second, remote location is not a direct connection through the internet. Instead, communication in both directions between the hearing professional's mobile device 22 at one location and the patient's hearing aid 12 and mobile device 14 at a remote location is streamed from its originating source to servers on the cloud 26 on the internet and streamed from the cloud 26 to its destination….. The conventional database server is a relational database server that stores a patient's historical settings, account information and scheduling details.
Manchester teaches storing in a cloud-based database service; (Manchester discloses that the streaming server stores patient’s identification and patent current attributes setting data, while the conventional database server stores a patient’s historical settings, account information and scheduling details in a cloud; See Manchester [0026] and [0031]).
Motivation: It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine/modify/adjust the combination of Westergaard and Brumback’s System and method for personalizing a hearing aid to include Manchester et al’s cloud-based database service to enable the storage of patient’s data. See Manchester [0016] [0026].
As per claim 7;
Manchester discloses; See paragraph [0042].
The method according to claim l, comprising: - evaluating statistically at least some of said uploaded data to said cloud-based database service in order to enable identification of specific issues related to at least one of a specific hearing aid user, a specific hearing care professional, a specific type of hearing aid, a specific hearing aid component and a specific repair process.
Manchester discloses collecting hearing aid usage statistics for different listening programs, calculating average daily usage over a selected time period and presenting the results to a hearing professional to evaluate the users hearing use. See Manchester, paragraph [0042].
Motivation: It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine/modify/adjust Westergaard’s System and method for personalizing a hearing aid to include Manchester et al’s cloud-based database service to enable the storage of patient’s data. See Manchester [0042].
As per claim 8;
Westergaard discloses, See [0046] [0053] [0055] [0058];
The method according to claim l, wherein the step of delivering said replacement hearing aid to said specific hearing aid user's residence or mailing address comprises the further steps of: - delivering a return box to said specific hearing aid user's residence or mailing address together with the replacement hearing aid, wherein said return box is prepared to enable a malfunctioning hearing aid to be returned to a hearing aid repair facility; wherein said return box comprises a questionnaire directed at determining why the malfunctioning hearing aid is returned, wherein information gathered from said questionnaire is stored in the data set of said specific user, and wherein this information will be available to facilitate a subsequent repairing of a hearing aid belonging to said specific hearing aid user by enabling the hearing aid repair facility to see the repair history of the specific hearing aid user when granted access to at least said part of the specific hearing aid user's data set.
Westergaard discloses, delivering personalized hearing-aid services by allowing authorized professionals to access the user’s stored hearing-aid data and by using that data to configure and provide a replacement hearing aid during repair or replacement. They also describe collecting user feedback, such as questionnaires, to update and improve the user’s hearing-aid settings and ingoing services. See Westergaard [0046] [0053] [0055] [0058].
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Westergaard et al; in view of Brumsback et al; in view of Manchester et al; in view of Giese et al [US 2022/003,6532 A1] hereafter Giese; in further view of Shonibare et al [US 2023/003,9728 A1] hereafter Shonibare.
As per claim 5;
The combination of Westergaard, and Brumsback does not disclose the following, however; Manchester discloses a session where a hearing professional remotely views and changes a patient’s hearing aid settings while the patient is using the hearing aid in real-time. See Manchester [0030]
The method according to claim l The method according to claim l comprising: - uploading, during normal hearing aid operation, the result of at least one type of hearing aid performance test to said cloud-based database service;
{See Manchester [0030]}
Manchester discloses that the streaming server stores patient’s identification and patent current attributes setting data, while the conventional database server stores a patient’s historical settings, account information and scheduling details; See [0026], [0031].
- storing in said cloud-based database service –
{[0026] The cloud 26 comprises a streaming server and a conventional data base server. The streaming server is a data streaming cloud server, such as Firebase, which is programmed to have special qualities that allow for live data streaming and recording of two-way communication between the hearing professional and the patient during an adjustment session so the server stores patient identification and patient current attribute settings data. The conventional database server is a relational database server that stores a patient's historical settings, account information and scheduling details.}
Motivation: It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine/modify/adjust the combination of Westergaard and Brumback’s System and method for personalizing a hearing aid to include Manchester et al’s cloud-based database service and remote access to enable real time setting of the users hearing aid. See Manchester [0026] [0030-0031].
Westergaard discloses;
- additional data comprising at least one of: a hearing care professional responsible for the hearing aid user or the specific over-the-counter procedure used by the hearing aid user, a hearing aid repair facility having repaired a hearing aid worn by the hearing aid user;
Westergaard discloses the hearing care professional responsible for a hearing aid user; {See [0038]- [0044]}
Westergaard and Manchester does not explicitly disclose, a hearing aid repair facility having repaired a hearing aid worn by the hearing aid user, however Brumback discloses see [0010] [0041].
{[0010] A delay of more than a few days for the repair of a hearing instrument, ear mold, or other ear device is not only very inconvenient to the client, but also poses potential psychological, social, and safety risks to the client.
[0041] If a client simply needs a new electronic module for placement in his ear piece shell, then a new electronic module is produced at the ear dispensing location and plugged into the existing shell all within the time period of a few hours. If the patient needs replacement of his existing ear piece shell, he can have a new one produced within three and one-half hours according to the methods described in FIGS. 2 and 4 and use the existing electronic module to plug into the new shell so that the client is provided with a hearing aid device in a matter of hours rather than a matter of days.}
Motivation: It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine/modify/adjust the combination of Westergaard, and Manchester’s System and method for personalizing a hearing aid to include Brumback et al’s repairing a hearing aid by a hearing aid facility to enable a rapid fix to the fault. See Brumback [0010] [0041]
The combination of Westergaard, Brumback and Manchester does not explicitly disclose the following, however; Giese discloses the fault recognition may be initiated manually by the hearing aid use or automatically at a scheduled time or remotely by a specialist through an auxiliary device; See paragraph [0019] and [0036] of Giese.
wherein said hearing aid performance test is initiated by the hearing aid user and/or the hearing aid is adapted to automatically carry out hearing performance tests with regular intervals and/or in response to some specific trigger event; and
{[0019] and [0036] The fault recognition by means of image comparison by the analysis unit is initiated by the user himself or herself or automatically from time to time or at specific points in time or by a specialist, for example, in the scope of remote maintenance, or a combination thereof. For example, the method can be initiated from an app on a smartphone or another auxiliary device by the user or automatically.}
Giese discloses,
wherein said types of hearing aid performance tests are directed at detecting at least one of: a defect or malfunctioning hearing aid component, ear wax clogging of a wax guard or a vent, and an in-the-ear part of the hearing aid not being correctly positioned inside the ear of the hearing aid user;
{Giese discloses, the system compares the captured image with reference image representation known as faultless and faulty conditions to identify specific fault such as clogged microphone openings, See Giese [0019] [0036] [0023- 0025] [0032] and [0038].}
Motivation: It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine/modify/adjust the combination of Westergaard, Brumback and Manchester’s System and method for personalizing a hearing aid to include Giese et al’s manual and automatic real time remote access to enable the specialist administer aid to the patient and for identification of defect. See Giese [0023]- [0025]; [0032] and [0038]
The combination of Westergaard, Brumback, Manchester and Giese does not explicitly disclose the following, however; Shonibare discloses collecting test data and patient information such as the lifestyle, age, preferences, medical history to provide the information need ed for selecting or recommending an appropriate hearing device. See Shonibare [0045] and [0051].
- personal hearing aid user information comprising at least one of: data identifying the specific hearing aid user, the age of the hearing aid user, the sex of the hearing aid user, hearing aid types worn by the hearing aid user, when and for how long each of said worn hearing aids has been worn, repair history for at least one of said worn hearing aids including whether and in the affirmative what type of hearing aid component defect or other type of malfunctioning was identified; and –
[0045] The technique 700 includes an operation 702 to obtain patient information including audiological diagnostic data and patient-specific data of a patient. The patient-specific data may include patient lifestyle, demographic information (e.g., age), hearing aid preference, work environment, cognitive ability, location (e.g., city or state), hearing assistance device history (e.g., previous experience with a hearing assistance device or brand new to hearing assistance devices), medical history data, or the like.
Shonibare discloses the input of a patient data into a trained machine learning model to predict the most suitable hearing assistance device shell, enabling an audiologist to determine whether a custom or standard hearing assistance device is the best fir for a user. See Shonibare [0033 -0035].
- using said data sets, from each of said plurality of hearing aid users, to train a neural network- based prediction model to predict the best possible repair approach, such as the best hearing aid component or hearing aid feature to diagnose first; and - using said trained neural network-based prediction model to predict the best possible repair approach for a given specific hearing aid.
[0033 - 0035] The process 400 illustrates an end-to-end technique for generating a hearing assistance device for a user. Based on the output of a machine learned model, an audiologist may determine whether a custom or a standard hearing assistance device is the best fit for a user. The process 400 includes determining whether the user requires hearing assistance at decision operation 402. When a hearing assistance device is not needed, other treatment or a referral may be provided at operation 404. When a hearing assistance device is needed, information may be gathered (e.g., an audiological test, a questionnaire, etc.) at operation 406. Patient data may be input in a trained model at operation 408, and a predicted hearing assistance device shell may be output via the model at operation 410.
Motivation: It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine/modify/adjust the combination of Westergaard, Brumback, Manchester and Giese’s System and method for personalizing a hearing aid to include Shonibare et al’s collection of test data and patient information such as the lifestyle, age, preferences, medical history, input of a patient data into a trained machine learning model to predict the most suitable hearing assistance device to enable the specialist administer aid to the patient. See Shonibare [0033 -0035] and [0045] and [0051].
Claim(s) 6 are rejected under 35 U.S.C. 103 as being unpatentable over Westergaard et al; in view of Brumback et al; in view of Manchester et al; in view of Giese et al, in view of Shonibare et al, in further view of Casper et al [US 2024/005,6747 A1] hereafter Casper.
As per claim 6;
The combination of Westergaard, Brumback, Manchester and Giese does not explicitly disclose the following, however; Shonibare discloses the use of a trained machine learning model to evaluate how well a patients’ characteristics match different hearing assistance device models. See Shonibare [0047].
The method according to claim 5, wherein said step of training a neural network-based prediction model comprises the steps of: - obtaining, from said cloud-based database service, data representing input and corresponding output of the neural network-based prediction model whereby supervised learning of the neural network-based prediction model is enabled and wherein input feature vectors of said neural network-based prediction model comprises elements representing at least some of: said personal hearing aid user information, said additional data and said results of at least one type of hearing aid performance test;
{[0047] The technique 700 includes an operation 706 to determine a correlation between the input vector and each of a plurality of feature vectors using machine learning, the plurality of feature vectors corresponding to a plurality of hearing assistance device models. Operation 706 may include determining the correlation using the input vector and a plurality of feature vectors as inputs for a machine learning trained model. The machine learning trained model may be trained based on a data set including, for example, audiological diagnostic data and patient-specific data corresponding to returned hearing assistance devices or corresponding to hearing assistance devices that were not returned. In this example, the audiological diagnostic data may include at least one of an audiogram, a speech reception threshold, a word recognition score, a middle ear function testing result, or the like.}
Motivation: It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine/modify/adjust the combination of Westergaard, Brumback, Manchester and Giese’s system and method for personalizing a hearing aid to include Shonibare et al’s input of a patient data into a trained machine learning model to predict the most suitable hearing assistance device to enable the specialist administer aid to the patient. See Shonibare [0047].
The combination of Westergaard, Brumback, Manchester, and Shonibare, does not disclose the following, however; Giese discloses identifying a specific fault and recognizing whether a hearing aid component is faulty by comparing an actual and reference image. See [0023]- [0025] and [0032]
wherein said output of said neural network-based prediction model represents a specific hearing aid component defect or another type of malfunctioning;
{[0032] In conjunction with the recognition of soiling as in the above-described embodiment, an embodiment is advantageous in which the analysis unit, after cleaning of the component by the user, prompts the user to record an actual image of the component so that then the analysis unit effectively checks the correct cleaning of the component by the user in the scope of the fault recognition.}
Motivation: It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine/modify/adjust the combination of Westergaard, Brumback, Manchester and Shonibare’s System and method for personalizing a hearing aid to include Giese et al’s manual and automatic real time remote access to enable the specialist administer aid to the patient and for identification of defect. See Giese [0023]- [0025]; [0032] and [0038]
The combination of Westergaard, Brumback, Manchester, Giese and Shonibare does not explicitly disclose the following, however; Casper discloses a machine-learning framework in which a hearing aid uses a trained neural network to process audio signals and improve hearing performance. The neural network is trained using training data and may employ architectures such as feedforward neural networks before being deployed to the hearing device. Paragraph [0140]- [0158] focuses on training, neural network architecture and operation to enhance audio processing.
- selecting a neural network architecture such as a feedforward neural network;
{See Paragraph [0140] - [0158] of Casper.}
Casper discloses the use of a machine-learning model, such as a neural network, to process audio signals in a hearing aid and support improved performance. See Casper [0140];
{[0140] Backpropagation of errors is a common method used to train neural networks. An input vector is presented to the network for processing. The output of the network is compared to the desired output using a loss function and an error value is calculated for each of the neurons in the output layer.}
Motivation: It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine/modify/adjust the combination of Westergaard, Brumback, Manchester, Giese and Shonibare’s System and method for personalizing a hearing aid to include Casper et al’s machine-learning framework in which a hearing aid uses to enable a trained neural network to process audio signal. See Casper [0023]- [0025]; [0032] and [0038]
Shonibare discloses training a machine learning image classifier using labeled images of hearing aid components and validating its performance to estimate classification accuracy and reduce overfitting before deployment. See Shonibare [0026] and [0027].
- splitting the input feature vectors and the corresponding output into a training set and a validation set and feeding the training set into said neural network-based prediction model and adjust the neural network weights based on backpropagation and;
{[0026-0027] The model may be evaluated at operation 208. The classification accuracy may be estimated from an error rate. To avoid overfitting, out-of-sample testing may be used to validate the model. A round of validation may include splitting the training set into k complementary subsets. The classifier is then trained using k−1 of the subsets, leaving one out for testing at operation 208. This may be repeated for all k subsets. The error rate may be obtained as the average of validation results from each subset.}
Shonibare discloses, See [0028]
- using the validation set to check the performance of said trained neural network-based prediction model in order to avoid overfitting.
{Shonibare discloses that after the machine learning classifier has been trained and validated, it is used to classify images of hearing aid components to determine whether the components are faultless or to identify specific faults. See [0028]}
Motivation: It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine/modify/adjust the combination of Westergaard, Brumback, Manchester, Giese and Casper’s System and method for personalizing a hearing aid to include Shonibare et al’s machine learning image classifier to enable the specialist administer aid to the patient. See Shonibare [0026] and [0027].
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Westergaard et al; in view of Brumback et al; in view of Manchester et al; in further view of Shonibare et al [US 2023/003,9728 A1] hereafter Shonibare.
As per claim 10;
The combination of Westergaard, Brumback, and Manchester does not explicitly disclose the following, however; Shonibare discloses the patient data is input into a trained machine learning model to predict the most suitable hearing assistance device shell, enabling an audiologist to determine whether a custom or standard hearing assistance device is the best fir for a user. See Shonibare [0033 -0035].
The hearing aid repair system according to claim 9, further comprising a neural network-based prediction model trained to predict the best possible repair approach, such as the best hearing aid component or hearing aid feature to diagnose first.
{[0033 - 0035] The process 400 illustrates an end-to-end technique for generating a hearing assistance device for a user. Based on the output of a machine learned model, an audiologist may determine whether a custom or a standard hearing assistance device is the best fit for a user. The process 400 includes determining whether the user requires hearing assistance at decision operation 402. When a hearing assistance device is not needed, other treatment or a referral may be provided at operation 404. When a hearing assistance device is needed, information may be gathered (e.g., an audiological test, a questionnaire, etc.) at operation 406. Patient data may be input in a trained model at operation 408, and a predicted hearing assistance device shell may be output via the model at operation 410.}
Motivation: It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine/modify/adjust the combination of Westergaard, Brumback and Manchester’s System and method for personalizing a hearing aid to include Shonibare et al’s machine learning image classifier to enable the specialist administer aid to the patient. See Shonibare [0026] and [0027].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Schneider et al; [US 2012/0183166A1], discloses A method for adjusting a second hearing device in dependence of a first hearing device is proposed.
R. Einhorn, "Modern hearing aid technology — A user's critique," 2016 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), Orlando, FL, USA, 2016, pp. 81-84.
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/VICTOR CHIGOZIRIM ESONU/
Examiner, Art Unit 3629
/SARAH M MONFELDT/Supervisory Patent Examiner, Art Unit 3629
