DETAILED ACTION
The Examiner acknowledges the amendments received 17 February 2026. Claims 1-32, 37, 41-42, 47, 49-50, 52-58 and 63-89 are cancelled; new claims 90-92 are added; claims 33-36, 38-40, 43-46, 48, 51, 59-62 and 90-92 are pending.
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, see “Remarks”, filed 17 February 2026, with respect to the rejection(s) of claim 33 and its dependent claims under Jooste have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Tzvieli.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 92 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The Applicant cited part. 0160 and 0164-0167, as well as Figure 9, as supporting the newly presented limitation of “the system is configured to provide the audible warning upon detecting the at least one allergic reaction trigger as being imminent to the system.” Neither there, nor elsewhere in the Disclosure as originally filed, is there support for the audible warning provided subsequent to detecting an imminent allergic reaction trigger. In every instance where the electroacoustic transducer issues information to the user, it is relevant to “information relating to allergic reactions”, but does not explicitly convey an imminent allergic reaction trigger as claimed.
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.
Claims 33-36, 38-40, 43-46, 48, 51, 59-62 and 90 are rejected under 35 U.S.C. 103 as being unpatentable over Jooste (U.S. 2015/0170504) in view of Tzvieli et al (U.S. 2020/0085311). Jooste discloses (Figures 7A-7B) a first ear-wearable device, the first ear-wearable device comprising a first control circuit (718); a first microphone, wherein the first microphone is in electrical communication with the first control circuit; and a first sensor package, wherein the first sensor package is in electrical communication with the first control circuit; a second ear-wearable device, the second ear-wearable device comprising a second control circuit (“HMD 702 may also include a wireless transceiver for communicating with a remote device, such as a positioning device 300”); a second microphone (“one or more microphones”), wherein the second microphone is in electrical communication with the second control circuit; and a second sensor package (“one or more sensors”), wherein the second sensor package is in electrical communication with the second control circuit; wherein the ear-wearable system is configured to (par. 0074-0078) evaluate at least one of signals from the first microphone, signals from the second microphone, signals from the first sensor package, signals from the second sensor package, signals from an external sensor, and contextual factor data; predict or detect the onset or presence of an allergic reaction (par. 0050) based on the evaluation; and detect at least one allergic reaction trigger based on the evaluation, wherein the at least one allergic reaction trigger comprises an allergen (par. 0025 and 0049).
Jooste discloses the claimed invention except for the ear wearable system is configured to determine whether the allergic reaction trigger falls within a lookback period; and when the allergic reaction trigger falls within the lookback period, classify the allergic reaction trigger as an actual trigger that results in allergic reactions for a device wearer; and when the allergic reaction trigger does not fall within the lookback period, classify the allergic reaction trigger as not being an actual trigger that results in allergic reactions for the device wearer. Tzvieli, however, discloses (par. 0335 right and left in-the-ear earbuds including microphones that (par. 0444-0445) monitor allergic reactions including (par. 0474-0476) a time indicative of when the user was affected by an allergic trigger, including “an effect of a potential trigger is indicative how much the potential trigger influences the extent of the user's allergic reaction, which can range from no influence to a profound influence”.
Jooste and Tzvieli both disclose systems for using ear-worn microphones to sense allergic reaction triggers. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Jooste’s two ear-wearable systems with Tzvieli’s lookback period (“indications include a list of periods of time during which various potential triggers affected the user”) in order to narrow down the actual trigger among many possible triggers.
Regarding claim 34, Jooste discloses (par. 0074-0078) the signals from the first microphone, signals from the second microphone, signals from the first sensor package, signals from the second sensor package and/or signals from the external sensor reflect signals from one or more physiologic sensors and/or one or more non-physiologic sensors.
Regarding claim 35, Jooste discloses (par. 0097-0098) the ear-wearable system is configured to detect the allergic reaction by matching a signal pattern with one or more predetermined patterns indicating the presence of an allergic reaction.
Regarding claim 36, Jooste discloses (par. 0024) the ear-wearable system is configured to detect wheezing or stridor using microphone data.
Regarding claim 38, Jooste discloses (par. 0103) detecting changes in fundamental frequency (F0).
Regarding claim 39, Jooste discloses (par. 0024) the ear-wearable system is configured to detect words or phrases indicative of an allergic reaction.
Regarding claim 40, Tzvieli discloses (par. 0737) the ear-wearable system is configured to detect skin color changes using the camera data.
Regarding claim 43, Jooste discloses (par. 0099-0102) the ear-wearable system is configured to change an allergic reaction detection parameter or threshold following detection of the allergic reaction trigger.
Regarding claim 44, Jooste discloses (par. 0025 and 0049) the ear-wearable system is configured to identify at least one suspected allergen following detection of the allergic reaction trigger.
Regarding claim 45, Jooste discloses (par. 0031-0032) the ear-wearable system is configured to query a device wearer regarding a detected onset or presence of an allergic reaction.
Regarding claim 46, Jooste discloses (par. 0031-0032) the ear-wearable system is configured to query a device wearer regarding a severity of a detected allergic reaction.
Regarding claim 48, Jooste discloses (par. 0025 and 0049) at least detection of local weather data, local pollen data, and environmental data.
Regarding claim 51, Jooste discloses (par. 0020) at least evaluation of respiration rate.
Regarding claim 59, Jooste discloses (par. 0050) the ear-wearable system is configured to classify a detected allergic reaction.
Regarding claim 60, Jooste discloses (par. 0031-0032) the ear-wearable system is configured to deliver a suggestion to a device wearer regarding an action to take.
Regarding claim 61, Jooste discloses (par. 0099-0102) the ear-wearable system is configured to execute a mitigating action when an allergic reaction is detected.
Regarding claim 62, Jooste discloses (par. 0074-0078) the ear-wearable system is configured to output data regarding a predicted or detected onset or presence of an allergic reaction to an external device.
Regarding claim 90, Tzvieli discloses (par. 0482) the lookback period is between about ten seconds and 60 minutes.
Allowable Subject Matter
Claim 91 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached on (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792