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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/16/26 has been entered.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims are addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 1, 2, 7-10, 13, 14, 16, 19, 23, 25-27, 29, 34, 42-44, 73, and 117-119 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shalon (US 20110125063 A1).
For claim(s) 1, 44, and 73, Shalon teaches
An ear-worn device system [entire disclosure – see at least abstract] comprising:
a first ear-worn device, [Figs. 1 and 15-17] the first ear-worn device comprising a control circuit;
a motion sensor, wherein the motion sensor is in electrical communication with the control circuit; [¶¶62-66]
at least one microphone, wherein the at least one microphone is in electrical communication with the control circuit; [¶¶71-76]
an electroacoustic transducer, wherein the electroacoustic transducer is in electrical communication with the control circuit; [¶75]
and a power supply circuit, wherein the power supply circuit is in electrical communication with the control circuit; [¶¶62-86 esp. ¶86]
a second ear-worn device; [¶¶62-86 in view of ¶451]
PNG
media_image1.png
4
4
media_image1.png
Greyscale
wherein the ear-worn device system is configure
ed to monitor signals from at least one of the motion sensor and the at least one microphone and evaluate the signals to identify oropharyngeal events [¶¶62-86 et seq.]
wherein signal evaluation to identify oropharyngeal events includes evaluating signals from the microphone of the first ear-worn device and signals from a microphone of the second ear- worn device and selecting those signals emanating from a spatial location that is laterally between the first ear-worn device and the second ear-worn device and posterior to the lips of the ear-worn device wearer [¶¶71-77, see at least ¶77 stating ‘Software can be used to select which microphone is given priority for data collection and analysis based on the situation’]
and distinguish normal swallowing events from abnormal swallowing events based on a sequence of identified oropharyngeal events [historic algorithm training in ¶107, ¶116 constitute(s), under BRI, a form of sequential evaluation, see then ¶¶145-164]
and distinguish bruxism from mastication. [¶71, ¶75]
For claim(s) 2, Shalon teaches
wherein the oropharyngeal event is selected from the group consisting of mastication, swallowing, and aspiration. [¶71]
For claim(s) 7-8, Shalon teaches
wherein signal evaluation to identify oropharyngeal events includes evaluating signals from the microphone to identify signals between 0 and 1.5 kHz. [¶62]
For claim(s) 13-14 and 16, Shalon teaches
wherein signal evaluation to identify oropharyngeal events includes evaluating signals from the motion sensor to identify head or jaw movement followed sequentially by evaluating signals from the microphone to identify swallowing based on a cluster of mastic events. [historic algorithm training in ¶107, ¶116 constitute(s), under BRI, a form of sequential evaluation]
For claim(s) 19, Shalon teaches
wherein signal evaluation to identify oropharyngeal events includes binary mastication detection per second. [¶71, ¶175]
For claim(s) 23-26, Shalon teaches
wherein the ear-worn device system is configured to distinguish normal swallowing events from abnormal swallowing events based on a timing of identified oropharyngeal events. [¶71, ¶73, ¶¶206-216]
For claim(s) 27, 29, and 34, Shalon teaches
wherein the ear-worn device system is configured to generate an alert if abnormal oropharyngeal events are detected crossing a threshold value, after an amount of time, or if fluid intake falls below a value. [¶¶145-164]
For claim(s) 42 and 43, Shalon teaches
the at least one microphone comprising an intracanal microphone. [Fig. 9 with sensor 904 in view of ¶451]
For claim(s) 117, Shalon teaches
the system is configured to evaluate signals from the microphone of the first ear-worn device and signals from the microphone of the second ear-worn device, select signals originating at or near a sound origin associated with speech, and discard signals originating at other points within the body of an ear-worn device wearer. [¶¶71-77]
For claim(s) 118, Shalon teaches
the system is configured to identify any of coughing, gagging, aspiration or breathing cessation after detection of mastication as an abnormal swallowing event. [¶71]
For claim(s) 119, Shalon teaches
the system is configured to distinguish bruxism from mastication based on timing and/or a posture of an ear-worn device wearer. [¶71]
Response to Arguments
Applicant's 1/16/26 arguments with respect to the prior art have been fully considered but they are not persuasive.
Applicant argues in remarks p. 8-10 that Shalon fails to teach selecting signals from between the two microphones as Shalon instead only teaches only teaches selecting signals originating from the body (i.e., as opposed between the ear devices). Examiner respectfully disagrees.
Shalon ¶71 states
Acoustic energy generated by chewing, swallowing, biting, sipping, drinking, teeth grinding, teeth clicking, tongue clicking, tongue movement, jaw muscles or jaw bone movement, spitting, clearing of the throat, coughing, sneezing, snoring, breathing rate, breathing depth, nature of the breath, heartbeat, digestion, motility to or through the intestines, tooth brushing, smoking, screaming, user's voice or speech, other user generated sounds, and ambient noises in the user's immediate surroundings can be monitored through one or more sensors (e.g. microphones) positioned in or around the ear area, on the skull, neck, throat, chest, back or abdomen regions. The preferred area allows for such sounds to be analyzed in order to determine the nature of the bolus swallowed (type of food, number of chews, hard versus soft chews, crunchy versus soft food, ingestion of liquid etc.). Microphones in different positions or orientations can be tuned to detect sounds originating within the user's body as opposed to ambient sounds surrounding the user. Software can be used to select which microphone is given priority for data collection and analysis based on the situation. Each microphone can be optimized to receive a specific range of sound frequencies corresponding to the signal to be measured. The sensing element can be designed to be sensitive to a wide range of frequencies of the acoustic energy generated in the head region, ranging from approximately 0.001 hertz up to approximately 100 kilohertz. The sensing element can be sensitive to just a narrow range of frequencies and a multiplicity of sensing elements used to cover a broader range of frequencies. The sensing element can receive the acoustic energy via air transmission, tissue or bone conduction.
(emphasis)
Instead, Shalon teaches in ¶71 both of distinguishing body from ambient sounds as well as determining eating sounds — which would be sounds originating from between a user’s ears — in the selective activation and signal analyses of the array of body-worn microphones.
Applicant argues in remarks p. 10-12 that Shalon fails to teach determining abnormal swallowing events as determining swallow speed / frequency as in Shalon ¶146 is not an identification of abnormal swallowing. Examiner respectfully disagrees. Applicant’s position in remarks p. 10-12 does not take into account the BRI of the term ‘abnormal’. The characterization of swallows throughout Shalon ¶¶145-164 esp. ¶¶142-146 details frequency, intensity, number, rate, and other parameters which, when used for feedback as in Shalon ¶¶47-55, well and reasonably constitutes at least some form of determining abnormal swallowing. Examiner suggests Applicant more specifically limit the type of abnormal swallowing that is determined instead of determining abnormal swallowing per se.
Applicant argues in remarks p. 12-13 that Shalon fails to teach distinguishing grinding from swallowing. Examiner respectfully disagrees. As set forth previously, Shalon teaches in ¶71
‘Acoustic energy generated by…teeth grinding…jaw muscles or jaw bone movement…and ambient noises in the user's immediate surroundings can be monitored through one or more sensors’
And then in ¶71 and ¶75 details distinguishing swallowing events throughout such sounds — accordingly teaching at least some form of distinguishing bruxism from swallowing under BRI. To wit, since Shalon teaches determining swallowing sounds, then Shalon must teach determining swallowing from other sounds (including teeth grinding).
In summary, Applicant’s citations to this application’s specification to show distinctions between the claims and Shalon appear to be inconsistent with the BRI of the claim language. The features upon which applicant relies in the specification passages are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
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, Robert Chen can be reached on 571-272-3672. 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.
/BENJAMIN S MELHUS/Primary Examiner, Art Unit 3791
Prosecution Insights