DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
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, 8, 10, 13, 14, 16, 19, 23, 25-27, 29, 34, 42, 73, and 118 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shalon (US 20110125063 A1).
For claim(s) 1, 10, 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]
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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]
and discarding signals originating at other points within the body of an ear-worn device wearer. [discarding throughout ¶¶71-77 see at least ¶75]
and distinguish bruxism from mastication based on timing and/or a posture of an ear-worn device wearer. [¶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) 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]
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 44 and 120 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shalon in view of Ashby (US 20170270820 A1).
For claim(s) 44, 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]
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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) 44 and 120, Shalon fails to teach abnormal swallowing events being indicative of unsuccessful / incomplete swallowing.
Ashby teaches a chewing and swallowing evaluation system [abstract] comprising distinguishing abnormal swallowing being indicative of unsuccessful swallowing after repetitive swallowing patterns are identified. [choking warning in ¶65 from eating speed (including thereby a swallowing speed)]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the abnormal swallowing distinction of Shalon to incorporate the choking warning of Ashby in order to aid in ensuring a subject’s safety and health. As motivated by Ashby ¶65.
Response to Arguments
Applicant's 8/3/26 arguments with respect to the prior art for claim(s) 1 and 73 have been fully considered but they are not persuasive.
Applicant argues in remarks p. 8-9 that Shalon fails to teach discarding of signals originating at other points within the body. Examiner respectfully disagrees. Shalon details at length throughout ¶¶71-77 the analysis and contextualization of signals and thus at least a form of discarding unwanted / unused signals at least by the selection of other more pertinent signals for use. Further, Shalon teaches in ¶75 the explicit subtraction of ambient sounds to further classify eating sounds.
Applicant argues in remarks p. 11 that Shalon ¶71 fails to teach distinguishing bruxism from mastication based on a timing. Examiner respectfully disagrees. Shalon ¶71 details how grinding and/or sneezing (a change in posture in each instance) are detected along with chewing and swallowing which are classified and separated from grinding and other head / mouth movement types. Such contextualization of the sound signals in Shalon ¶71 includes at least some form of distinguishing of sound types based on timing and subject posture (i.e., a time of chew vs. swallow and a mouth/head/neck posture determined via a sound signal).
Applicant’s arguments with respect to claim(s) 44 and 120 have been considered but are moot because the arguments do not apply to the new combination of references being used in the current rejection.
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).
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.
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/BENJAMIN S MELHUS/ Primary Examiner, Art Unit 3791
