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 .
The current application has the priority of 06/16/2022 to PRO 63352954.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1, line 8 recites “the body of the patient received”, ‘received’ appears to be a typographical error, and should be removed from the claim. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “first signal detector” in claim 1 line, 2; this limitation is further defined as having the structures: “a body” and “a first earbud” in the same claim.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4, 5, 7, 10, 13-15, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barnacka et al. US 2021/0015442 A1 (hereinafter “Barnacka’442”) incorporating Barnacka et al. US 2019/0247010 A1 (hereinafter “Barnacka’010”).
Note: Barnacka has a publication date of 01/21/2021, which is more than one year prior to the effective filing date of 06/16/2022 of the instant application.
Reference Barnacka’442 in [0003-0004] fully incorporates Barnacka’010”. This incorporated reference is applied in the following rejection to teach the structure of an earbud sensor 102/103. All citations are made to Backnacka’442, unless otherwise specified to Backnacka’010.
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Regarding claim 1, Barnacka’442 teaches an auscultation system (Abstract: system and method for heartbeat detection; Fig.1: cardiology system 10), the system comprising:
a first signal detector (in-ear biosensor system 102-1) that is configured to detect biosignals (biosignals 101) including infrasonic and audible signals from a body of a patient ([0098] biosignals including infrasonic signals, also see [0096, 0100] detecting biosignals and acoustic signals in the infrasonic range), wherein the first signal detector (102-1) includes:
a body (see Barnacka’010 Fig.10: earbud cover 801); and
a first earbud ([0098]102-1 includes a left ear bud 103L, alternatively, also see Backnacka’010: Fig. 10 and [0109-0110] earbud 102/103) coupled to the body of the signal detector (Backnacka’010: [0110] the “body” i.e. earbud cover 801 is placed over the ear canal extension 205 of an earbud 102/103), wherein the first earbud (102-1) includes an acoustic sensor ([0143: 2nd sentence] infrasound/vibration sensors 276 are acoustic sensors) that is configured to detect the biosignals (101) from the body of the patient [received] ([0143, 0147-0148] detect biosignals, e.g. sounds and vibrations from cardiovascular component in the infrasonic range), via the body of the first signal detector (Barnacka’010: Figs. 1 and 10, [0110, 0117] the “body”, i.e. earbud 801, is inserted into the ear canal, so that the earbud 102 is able to detect biosignals 101; also see Barnacka’442: Figs. 1 and 9, [0170]); and
a network interface (network interface 176) configured to forward the biosignals from the first signal detector (Figs. 1 and 6, and [0144, 0146] network interface 176 transmits biosignals to an application server 132 via wireless connection 66-2 as shown in Fig. 1).
Regarding claim 4, Barnacka’442 discloses the system of claim 1, further comprising a second earbud (102-1 includes right earbud 103R) that is configured to detect biosignals including infrasonic and audible signals from the body of the patient ([0143, 0147-0148] detect biosignals in the infrasonic range)
Regarding claim 5, Barnacka’442 discloses the system of claim 4, wherein the second earbud (103R) is configured to be placed at an ear canal of the patient and is configured to detect the biosignals from the ear canal (as shown in Fig.1: 103L and 103R both inserted into the ear canal; also see [0111-0112]), and wherein the network interface (controller interface 280) is configured to forward the biosignals from the second earbud ([0145] and Fig. 6, controller 280 transmits detected biosignal data via data connection 106 to user device 107 exemplary as shown in Fig. 1 and [0102-0103]).
Regarding claim 7, Barnacka’442 discloses the system of claim 4, further comprising a second signal detector (earbud 103R and controller board 105, together are taken to encompass “second signal detector” in the claim) that includes a body (Barnacka’010: earbud cover 801; see rationale to claim 1 rejection) and includes the second earbud (103R), wherein the second earbud is coupled to the body of the second signal detector (see rejection to claim 1 above regarding coupling of cover 801 to earbud 102/103), and wherein the body of the second signal detector includes a base (Barnacka’010: the distal tip of cover 801 is taken to encompass “base” in the claim) that is configured to be positioned against the body of the patient (inside the ear canal as shown in Barnacka’442: Figs. 3 and 5; and Barnarcka’010: Fig. 1 and [0050]), and wherein the second signal detector is configured to send the biosignals to the network interface (see Fig. 6, the controller interface 280 transmits biosignals to network interface 176 via earbud connection 106).
Regarding claim 10, Barnacka’442 discloses the system of claim 1, wherein the body of the first signal detector includes a membrane that is configured to enable the coupling of the first earbud to the body (Barnacka’010: [0110] cover 801 comprises rubber material, that is conformable to the ear canal, this is taken to encompass “membrane” in the claim), to provide an acoustic seal between the first earbud and the body (Barnacka’010: [0117] earbud 801 creates a complete seal around the ear canal for occlusion effect), and to enable removeable attachment of the first earbud from the body (the earbud cover 801 is removable to change to different size covers for accommodating different size ear canals; see Barnacka’010: [0108: last sentence]).
Regarding claim 13, Barnacka’442 discloses the system of claim 1, wherein the first earbud (103L) is a wireless earbud (Fig.7: 103L is a wireless version; also see [0107-0108]), and wherein the network interface is a wireless network interface of the first earbud (Fig. 7: wireless link 66-1; [0107-0108]).
Regarding claim 14, Barnacka’442 discloses the system of claim 1, wherein the first earbud (103L) includes at least one motion sensor (Fig. 6: motion sensor 274) that facilitates positioning and orientation of the first signal detector relative to the body of the patient ([0168]: last 2 sentences] “The signals from auxiliary sensors 274 and 279 can also be used to help assess seal level (i.e. occlusion level of the at least one earbud in the ear canal)”; [0173] discusses seal level, representing the proper positioning/fit of the earbud 103).
Regarding claim 15, Barnacka’442 teaches a method for acquiring biosignals (Abstract: system and method for heartbeat detection; Fig.1: cardiology system 10), the method comprising:
providing a first signal detector (in-ear biosensor system 102-1) that detects biosignals (biosignals 101) including infrasonic and audible signals from a body of a patient ([0098] biosignals including infrasonic signals, also see [0096, 0100] detecting biosignals and acoustic signals in the infrasonic range), the first signal detector (102-1) including:
a body (see Barnacka’010 Fig.10: earbud cover 801) including a base (Barnacka’010: the distal tip of cover 801 is taken to encompass “base” in the claim); and
a first earbud ([0098]102-1 includes a left ear bud 103L, alternatively, also see Backnacka’010: Fig. 10 and [0109-0110] earbud 102/103) coupled to the body (Backnacka’010: [0110] the “body” i.e. earbud cover 801 is placed over the ear canal extension 205 of an earbud 102/103), the first earbud (102-1) including an acoustic sensor ([0143: 2nd sentence] infrasound/vibration sensors 276 are acoustic sensors) detecting the biosignals from the body of the patient via the body of the first signal detector (Barnacka’010: Figs. 1 and 10, [0110, 0117] the “body”, i.e. earbud 801, is inserted into the ear canal, so that the earbud 102 is able to detect biosignals 101; also see Barnacka’442: Figs. 1 and 9, [0170]);
positioning the base (distal tip of cover 801) against the body of a patient to receive biosignals (Barnacka’010: Figs. 1 and 10, [0110, 0117] the “body”, i.e. earbud 801, is inserted into the ear canal, so that the earbud 102 is able to detect biosignals 101; also see Barnacka’442: Figs. 1 and 9, [0170]); and
forwarding the received biosignals (101) toward a remote device (application server 132) across a network (network 108) (Figs. 1 and 6, and [0144, 0146] network interface 176 transmits biosignals to an application server 132 via wireless connection 66-2 as shown in Fig. 1).
Regarding claim 18, Barnacka’442 discloses the method of claim 15, further comprising: positioning a second earbud (102-1 includes right earbud 103R) at an ear canal of the patient that detects the biosignals including infrasonic and audible signals from the body of the patent in the ear canal ([0143, 0147-0148] detect biosignals in the infrasonic range); and forwarding the detected biosignals (101) toward the remote device across the network ([0145] and Fig. 6, controller 280 transmits detected biosignal data via data connection 106 to user device 107 exemplary as shown in Fig. 1 and [0102-0103]).
Regarding claim 20, Barnacka’442 discloses the method of claim 18, further comprising:
positioning a base (distal tip of earbud seal 801) of a body (earbud seal 801, see rejection to claim 15) of a second signal detector against the body of the patient to receive biosignals (103R worn in the patient’s ear canal as shown in Fig. 1), the second earbud (103R) being coupled to the body of the second signal detector (Barnacka’010: Fig. 10), the second earbud (103R) detecting biosignals including infrasonic and audible signals from the body of the patient ([0143, 0147-0148] detect biosignals in the infrasonic range); and
forwarding the biosignals (101) sent by the first and the second signal detectors toward the remote device across the network. ([0145] and Fig. 6, controller 280 transmits detected biosignal data via data connection 106 to user device 107 exemplary as shown in Fig. 1 and [0102-0103])
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 11 is rejected under 35 U.S.C. 103 as being unpatentable over Barnacka’442 incorporating Barnacka’010 as applied to claim 1 above, and Lisy et al. US 9,579,060 B1 (hereinafter “Lisy”).
Regarding claim 11, Barnacka’442 discloses the system of claim 1, wherein the first signal detector (102-1) comprises a plurality of sensors, e.g. infrasound sensor 276, motion sensor 274 and pressure sensor 279 (as shown in Fig. 6); the monitoring system further comprising a conventional Halter monitor and/or patch electrode(s) for detecting ECG from a monitored person (Fig.1: 102-2 and [0099]); and wherein the network interface is configured to forward the electrical biosignals from the first signal detector (see [0117-0118] compressed biosignals 101C is forwards to application server 132, also see [0203, 0205] ECG diagnostic system). However, Barnacka’442 and Barnacka’010 do not disclose wherein first signal detector includes at least one ECG sensor that is configured to detect biosignals including electrical biosignals from the body of the patient.
Lisy, a prior art reference in the analogous field of head-worn health monitoring systems, discloses a pair of earbuds (as shown in Figs. 1A-1C) comprising surface sensors 12 and 16, adapted for detecting electric signals when the earbuds are worn inside the ear canal, for detecting ECG (col.47, ll.36-col.48, ll.8). Accordingly, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Barnacka’422’s earbud to further provide surface electrodes for detecting ECG signals, in view of Lisy; the motivation for doing so is this way, it would eliminate the need to provide secondary sensor 102-2 since the earbuds would be able to detect both infrasonic signals and ECG signals for monitoring cardiac conditions simultaneously. (Barnacka’422: [0224-0225] analysis of using both infrasonic signals and ECG signals for cardiac conditions)
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Barnacka’442 incorporating Barnacka’010 as applied to claim 1 above, and in view of Lim et al. US 2017/0318397 A1 (hereinafter “Lim”).
Regarding claim 12, Barnacka’442 discloses the system of claim 1, wherein the first signal detector (102-1) comprises a plurality of sensors, e.g. infrasound sensor 276, motion sensor 274 and pressure sensor 279 (as shown in Fig. 6) wherein the network interface is configured to forward detected plurality of biosignals detected by the first signal detector (see [0117-0118] compressed biosignals 101C is forwards to application server 132); but does not disclose wherein the first signal detector includes at least one ultrasound transducer that is configured to transmit ultrasound into and/or detect ultrasound reflected from the body of the patient.
Lim, a prior art reference in the analogous field of wearable health monitoring system discloses a wearable ultrasound transducer 20 mounted onto an earbud (Fig. 3), that is worn within an ear canal ([0050]). The ultrasound transducer 20 creates ultrasound modulation signals for activating a user’s auditory system ([0060]). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Barnacka’010 in view of Lim to further include the ultrasound transducer; the motivation for doing so is because an ultrasound transducer adapted within an earbud is particularly beneficial to activate an auditory system based on the proximity to cerebrospinal fluids. (Lim: [0060])
Claim Objection/Allowable Subject Matter
Claims 2, 3, 6, 8, 9, 16-17, 19, 21 and 22 are 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.
To objected claims 2, 3, 6, 8, 9, 16-17, 19, 21 and 22, Barnacka’422 and Barnacka’010 disclose a remote device (user device 107) including an application programming interface (API) (Fig.1 and [0102-0103] each user device 107 runs a cardiovascular user application- user app 40, that is in communication with application server 132) configured to receive the biosignals (101R as shown in Fig. 1) forwarded from the network interface (see Figs. 1 and 6, and [0097, 0144-0145] earbud connection 106 between the earbud 102-1 and the remote device 107); and a data analysis system (data analysis system 209) configured to access the biosignals at the API (application server 132; [0097, 0100-0101]); wherein the data analysis system (209) is configured to determine a heartbeat and heart sounds of the patient based upon the biosignals in conjunction with lung sound models ([0095, 0113, 0118] determines heart rhythms from the biosignals, including comparison to known heart condition models, e.g. arrhythmia; also see Fig. 12-flowchart of operation of data analysis system 209 and [0183, 0196, 0225] discusses models used in data analysis of biosignals).
However, neither Barnacka’010 nor Barnacka’442 teach wherein the body (earbud cover 801) of the first signal detector (earbud 102-1) includes a base that is configured to be positioned near a heart, or one or both lungs, or near an artery for detection biosignals. Further, neither Barnacka’010 nor Barnacka’442t each using two earbuds to position on the body in a collinear fashion near a same vessel, or for detecting a heartbeat of a fetus as recited in the current application.
Conclusion
Note to Applicant: The Applicant is invited to schedule an interview with the Examiner to expedite prosecution.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY X JIAN/
Primary Examiner, Art Unit 3792
November 20, 2025