DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/17/2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/17/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 12 and 20 recites the limitation "the first bend". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the indefinite limitation has been deemed to claim “a first bend”.
The term “sufficient to maintain static positioning” and/or “sufficient to prevent air gaps”, in Claims 1, 3, 12 and 20 are relative terms which renders the claims indefinite. The term “sufficient to maintain static positioning” and/or “sufficient to prevent air gaps” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification defines these force requirements through purely functional outcomes, which shift based on the unique anatomy of individual wearers. The specification fails to provide an objective numerical range, measure, standard, or testing protocol that would allow a person of ordinary skill to determine the specific boundaries of the claimed “sufficient” degree. For purposes of examination the indefinite limitation has been deemed to claim any about of force that is capable of maintaining status positioning and prevent air gaps.
The term “overbuild” in Claims 4, 8, 17 and 24 is a relative term which renders the claim indefinite. The term “overbuild” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the specification sets forth that the “overbuild” is a percentage larger, the specification fails to identify a baseline dimension (e.g., larger than an ear impression larger that the shell, larger than typical). Without a fixed standard, the percentage is mathematically indefinite because a person of ordinary skill could not calculate an “overbuild” without a physical starting boundary. For purposes of examination the indefinite limitation has been deemed to claim any amount of material that is capable of being overbuilt.
The terms “inhibit ambient light/sound” in Claims 6, 7, 15, 16, 22, 23 and 24 are relative term which renders the claim indefinite. The terms “inhibit ambient light/sound” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification defines the inhibition of light and sound as a functional result of the “overbuild”, however, the specification fails to provide an objective measure (e.g., opacity, material properties, density, form, thickness) and not a specific percentage of compression required to achieve such seal. Without a clear definition of material standards, a person of ordinary skill could not determine how to inhibit ambient light and sound. For purposes of examination the indefinite limitation has been deemed to claim any material that is capable of inhibiting light and sound.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200196073 A1 to Nielsen et al. (hereinafter, Nielsen).
Nielsen discloses an ear-wearable electronic device and method comprising inter alia:
a shell (earpiece 1) having an outer surface (earpiece housing 2 including pass-through areas/windows 14, 15 and portion of earpiece housing distal pass-through areas/windows 14, 15) that corresponds to an ear geometry of a wearer of the device ([0043] “…the earpiece housing is a custom housing for a specific user corresponding to a 3D shape of the outer ear and/or the ear canal of the user…”), the shell comprising a window through a proximal portion of the shell (pass-through areas/windows 14, 15) and positioned within an ear canal proximate the first bend of the ear canal when the device is deployed in the wearer’s ear ([0057] “…pass-through areas 14, 15, and can come into contact with the skin surface of the ear canal (not shown) on the user…”),
an optical sensor disposed in the window (secondary sensors 9, 10),
a biasing member having an outer surface (earpiece housing 2 including portion of earpiece housing proximal pass-through areas/windows 14, 15) that corresponds to a geometry of at least a portion of a pinna of the wearer’s ear ([0043] “…the earpiece housing is a custom housing for a specific user corresponding to a 3D shape of the outer ear and/or the ear canal of the user…”), the biasing member configured to generate a biasing force sufficient to maintain static positioning of the optical sensor relative to ear canal issues during wearer body and jaw movement ([0043] “…the earpiece housing is a custom housing for a specific user corresponding to a 3D shape of the outer ear and/or the ear canal of the user…”) ([0043] “The custom housing may be formed or moulded using a 3D model of the ear and the ear canal of the user… the force applied between the superior part of the ear canal and the inferior concha cava is optimal for the specific user. I.e. that the force between these two anatomical parts is applied in an optimum manner, thereby reducing risk that the user will have fatigue in the ear when using the earpiece.”),
where the optical sensor is configured to apply a constant pressure against the ear canal tissue in response to the biasing force generated by the biasing member ([0043] “The custom housing may be formed or moulded using a 3D model of the ear and the ear canal of the user… the force applied between the superior part of the ear canal and the inferior concha cava is optimal for the specific user. I.e. that the force between these two anatomical parts is applied in an optimum manner, thereby reducing risk that the user will have fatigue in the ear when using the earpiece.”),
where the biasing member is configured to generate an apposition force sufficient to prevent air gaps between the optical sensor and the ear canal tissue during wearer body and jaw movement ([0043] “The custom housing may be formed or moulded using a 3D model of the ear and the ear canal of the user… the force applied between the superior part of the ear canal and the inferior concha cava is optimal for the specific user. I.e. that the force between these two anatomical parts is applied in an optimum manner, thereby reducing risk that the user will have fatigue in the ear when using the earpiece.”),
where the window is positioned at a flat region of the ear canal proximal the first bend of the wearer’s ear when the device is deployed in the wearer’s ear (FIGS. 1 and 2), where the optical sensor is configured to produce signals indicative of one of or both of heart rate and blood oxygen saturation, where the optical sensor comprises a PPG sensor ([0045] “…sensor may be a Photoplethysmogram (PPG) sensor.”),
a seal arrangement configured to inhibit ambient light and sound from reaching the optical sensor when the device is deployed in the wearer’s ear ([0064] “In case the pass through area is a transparent element, such as a window, which may e.g. be of a transparent polymer which allows optical signals to pass through the pass-through area, the window may have a thickness that is approximately around 0.2 mm or more.”),
where the biasing member and the seal arrangement are configured to cooperate as a canal lock for retaining the device in the wearer’s ear ([0064] “In case the pass through area is a transparent element, such as a window, which may e.g. be of a transparent polymer which allows optical signals to pass through the pass-through area, the window may have a thickness that is approximately around 0.2 mm or more.”) ([0043] “The custom housing may be formed or moulded using a 3D model of the ear and the ear canal of the user… the force applied between the superior part of the ear canal and the inferior concha cava is optimal for the specific user. I.e. that the force between these two anatomical parts is applied in an optimum manner, thereby reducing risk that the user will have fatigue in the ear when using the earpiece.”),
the optical sensor is capable of being positioned at one of a concha-facing location, an anti-tragus-facing location, and a tragal-notch region when the device is deployed in the wearer’s ear (e.g., when the device is being inserted in the ear, the optical sensors are capable of passing by all of these locations),
producing sensor signals by the optical sensor positioned within the window of the shell of the device and calculating, using a processor of the device, one or both of heart rate and blood oxygen saturation of the wearer using the sensor signals ([0023]-[0024] and [0045]);
wherein the biasing member comprises an overbuild of material covering a portion of the biasing member surface configured to contact one or both of an antitragus and an antihelix of the wearer's ear ([0043] “The provision of a custom housing may ensure that the earpiece fits the user in an optimal manner, where the outer shape of the custom housing may have surfaces that match the surface areas of the outer ear of the user.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791