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 remarks concerning the previous § 103 rejections have been fully considered. While the Examiner generally agrees with Applicant’s summarization of the Goldstein and Honeyager references and agrees that the rejections based only on these two references have been overcome, the Examiner respectfully disagrees with the position that Kirszenblat fails to render obvious the newly added limitations in combination with Goldstein and Honeyager. Applicant does not provide any specific arguments against Kirszenblat or its use in combination with the other references. As noted in the rejections below, the combination of these three references renders obvious claim 1 as amended, in addition to newly added claims 21-22.
Claim Rejections - 35 USC § 103
Claims 1 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0112671 A1 to Goldstein (hereinafter “Goldstein”) in view of US 2003/0220584 A1 to Honeyager et al. (hereinafter “Honeyager”) in view of US 2018/0235540 A1 to Kirszenblat (hereinafter “Kirszenblat”).
Regarding Claims 1 and 21-22, Goldstein teaches a device comprising:
an in-ear fixture configured to seal an ear canal of a user (see e.g. FIGS. 4A-B and Para. 166);
an internal microphone coupled to receive an internal acoustic signal, propagating through the ear canal of the user (see e.g. Para. 81: “the earpiece can use the ear canal microphone to obtain heart rate, heart rate signature, blood pressure and other biometric information such as acoustic signatures from chewing or swallowing or from breathing or breathing patterns”);
a first electrode mounted on the in-ear fixture and configured to receive an electronic signal [specifically an electrocardiogram (ECG) signal] from skin in the ear canal of the user (see e.g. Para. 64: “In some embodiments, the sensors can be embedded or formed on or within an expandable element or balloon that is used to occlude the ear canal. Such sensors can include non-invasive contactless sensors that have electrodes for EEGs, ECGs …”; Para. 72: “the sensors can include electrodes …”; also see Paras. 191-194 discussing other incorporations of electrodes.)
a processor (4; see e.g. FIGS. 1A-B) that is coupled to an augmented reality headset (see e.g. Para. 65: “a pair of virtual reality (VR) or augmented reality (AR) “glasses”), the processor configured to identify a vital sign [specifically a blood pressure value] of the user based on the internal acoustic signal (see e.g. Para. 81: “the earpiece can use the ear canal microphone to obtain heart rate, heart rate signature, blood pressure and other biometric information such as acoustic signatures from chewing or swallowing or from breathing or breathing patterns”).
Goldstein fails to teach classifying portions of the internal acoustic signal as corresponding to different heart sounds indicative of different stages of a heartbeat of the user and identifying one of the classified portions based on spectral content of the internal acoustic signal. However, Honeyager teaches a similar ear-worn device with a sensor (e.g. 114) which measures different heart sounds (see e.g. Para. 11: “heart sounds are obtained by placing a transducer within an ear of a person to detect internally generated body sounds, producing a signal representative of the vibration and/or motion occurring within the ear, and processing said signal to extract heart sound and other physiological information” and Para. 50: “As shown in FIG. 1, the ear sensor device 110 is clearly able to detect the first and second heart sounds, S1 and S2”) for the purpose of then determining other physiological parameters including blood pressure (see e.g. Para. 64: “and a person's blood pressure or blood pressure trend”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Goldstein to also measure heart sounds, as seen in Honeyager, because it would predictably enhance the device by collecting additional useful medical diagnostic information.
Goldstein as modified teaches an in-ear device including both a microphone and an electrode and includes determining blood pressure based on the heart sound(s) (in view of the modification with Honeyager), as discussed above but fails to specifically teach determining the blood pressure based on a time delay between the electronic signal from the electrode and the heart sound identified in the internal acoustic signal from the microphone. However, using delay between these particular signals was a known methodology for obtaining blood pressure. Kirszenblat teaches an analogous in-ear device including at least one electrode and at least one microphone (see e.g. Para. 9: “the proximal signal comprises an electrocardiogram (ECG) pulse signal, and the distal signal comprises one of a phonocardiogram (PCG) signal obtained via a microphone located on the earpiece”) and in which the blood pressure may be calculated based on a delay between the signals from the electrode and microphone (see e.g. Para. 12: “deriving the PTT comprises computing a delay between the proximal and distal signals. According to one example, the method further comprises determining a blood pressure of the user based on the computed delay”; also see Paras. 60, 68-69). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Goldstein to determine a blood pressure based on a time delay between the electronic signal from the electrode and the heart sound identified (i.e. in view of Honeyager) in the internal acoustic signal from the microphone, because this was demonstrated to be a known suitable method for determining the blood pressure, and doing so would yield diagnostically relevant and valuable information. Specifically, while Kirszenblat doesn’t explicitly state that the S1 or S2 heart sound from Honeyager is the component of the PCG signal used in the computed delay, Honeyager demonstrates that the timing of the heart sounds is known to be relevant to the calculation of blood pressure, and thus looking at these two references together, one skilled in the art would have found it obvious to select Honeyager’s heart sound timing (e.g. timing of S2) for the computed delay discussed in Kirszenblat.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Goldstein in view of Honeyager and Kirszenblat as applied to claim 1 above, and further in view of US 2019/0096000 A1 in view of Boesen (hereinafter “Boesen”).
Regarding Claim 4, Goldstein as modified teaches an in-ear device including a microphone which can measure various signals indicative of movement of an internal organ (e.g. heart rate) as discussed above. Goldstein fails to specify if the internal microphone can be a contact microphone. However, the use of a contact microphone in an in-ear device for this purpose was known. Boesen teaches an analogous in-ear device including a contact microphone which can detect various sounds including movements of the heart (see e.g. Para. 64: “A bone conduction microphone 45B may be positioned near the temporal bone of the user's skull in order to receive sounds and vibrations directly from the bone. The sounds received by the bone conduction microphone 45B may include heartbeats, heart palpitations, heart arrhythmias, sounds indicative of a physical activity such as walking, running, jogging, or weightlifting, or other related sounds.”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Goldstein to utilize a contact microphone for detecting heart sounds because (1) this would merely involve using a known suitable sensor type demonstrated in the art to be capable of measuring heart movements, and/or (2) this would amount to a merely simple substitution of one known suitable microphone for another, both of which are known in the art to be suitable for the same purpose of measuring vital sign data including e.g. heart rate.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Goldstein in view of Honeyager and Kirszenblat as applied to claim 1 above, and further in view of US 10,771,888 B1 to Oishi et al. (hereinafter “Oishi”).
Regarding Claim 5, Goldstein as modified teaches an in-ear device including an internal microphone as discussed above. Goldstein also teaches a speaker (e.g. 27) and an external microphone (e.g. 32 and/or 34) and teaches comparing/mixing the signals from both microphones (see e.g. Para. 73: “Through appropriate mixing of the signal from the ear canal microphone and the ambient microphone, such mixing technique can provide for a more intelligible voice substantially free of ambient noise that is more recognizable by voice recognition engines such as SIRI by Apple, Google Now by Google, or Cortana by Microsoft”). However, Goldstein fails to specify that the speaker is provided with an acoustic waveform based on the mixing/comparing/filtering of the two acoustic signals together. Nevertheless, this methodology was known in the art, as seen in at least Oishi who teaches an analogous in-ear device which includes this limitation (see e.g. Col. 5 line 43 through Col. 6 line 9: “The controller 155 may instruct the speaker 150 to present audio content based in part on the sound from the local area detected by the outer acoustic sensor 140 and sound transmitted via tissue conduction, detected by the inner acoustic sensor 145 …” [the cited portion goes on to give several examples of this]). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Goldstein to have the processor filter the external acoustic signal with the internal acoustic signal to form an acoustic waveform to be provided to the speaker, as seen in Oishi, because doing so would advantageously provide enhanced outputs from the speaker.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Cited in prior action(s):
US 2019/0343480 A1 to Shute et al.: see e.g. the abstract and Paras. 67-73 (disclosing an earbud device which measures heart sounds).
US 2018/0049660 A1 to Sato: see e.g. Para. 2: “It is known that the heart sound has strong correlation with the blood pressure, and it is possible to estimate the blood pressure by suitably processing heart sound data using a computer” and Para. 59: “The blood pressure calculator 303 analyzes the noise-removed heart sound data, and outputs the blood pressure data.”
US 2011/0137141 A1: see e.g. Para. 31: “Alternatively, the microphone may be embedded within in-ear portion 210, for instance, a contact microphone that senses physical vibrations from a contact point within the ear canal, or even mounted upon behind-the-ear portion 202.”
US 2021/0360354 A1: see e.g. Para. 11: “The heartbeat detector may e.g. comprise a microphone (e.g. an in-ear-microphone), a movement sensor, or a PPG sensor. The microphone may be a microphone facing the eardrum when the hearing aid is mounted on the user. The microphone may be a bone conduction microphone.”
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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