2DETAILED 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/22/2025 has been entered. Accordingly, claims 1-7 and 9, 10, 12-15 remain pending, claims 1-7 and 9 have been amended, claims 8, 11, 16-17 were previously canceled, and claims 10, 12-25 having been previously withdrawn.
Response to Arguments
Preliminary matter
It is noted that in amended claim 4 filed 09/22/2025, applicant appears to have made amendments to the claim that are note indicated with proper marking, i.e., the amended portion of the claim as no underlining, namely, when applicant amended the term “reach” as filed 12/12/2024 to be “reaches” as presently filed 09/22/2025. This has been interpreted as a typographical error and the claim has been examined.
Rejections under 35 USC 112
In light of the claim amendments filed 09/22/2025, the specific rejections of the claims under 112(a) have been rendered moot and have been withdrawn.
Rejections under 35 USC 103
Applicant's arguments filed 09/22/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new grounds of rejection has been presented. Consequently, the arguments do not apply to new references or the new combination of the references being used in the current rejection.
Claim Objections
Claim 2 is objected to because of the following informalities: “the nozzle comprises a speaker…” should be amended to recite “the nozzle further comprises a speaker…”. Appropriate correction is required.
Claim 2 is further objected to because of the following informalities: the preamble recites “An earpiece as claimed in claim 1” should be amended to “The earpiece according to
Claims 3-7 and 9 are also objected to for reciting the same and/or similar preamble outlined above.
Claim 4 is objected to because of the following informalities: “the first emitter and second emitters positioned…” should be amended to recite “the first emitter and the second emitterare configured to be positioned…”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
All dependent claims are also rejected by the nature of their dependency.
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 1-7 and 9 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.
Claim 1 recites “the light sensor being in a cradle made into the surface of the nozzle” in lines 4-5, which renders the claim indefinite because it is unclear if applicant intends for the light sensor to be positioned or arranged in or be configured to be in a cradle, with first reciting a step of making the cradles into the surface of the nozzle. And/or if applicant meant that the nozzle comprises a surface, and a plurality of cradles extending inward from the surface of the nozzle, and the light sensor is configured to be positioned or is configured to be arranged into one cradle of the plurality of cradles of the nozzle. No active steps are recited in the claims for performing these functions. It appears, although it is unclear, that applicant is reciting intended use. Therefore, the limitations outlined in this rejection have been interpreted there as accordingly.
Claims 3-7 are also rejected for reciting the same and/or limitations outlined above.
All dependent claims are also rejected by the nature of their dependency.
Claim 4 is recites the limitation "the two emitters" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. It is unclear if applicant refers to the first emitter or second light emitter or second light emitters that are priorly recited in the present claim, or the light emitter, which is recited in the parent claim 1. Neither the light emitter of parent claim 1 nor the first light emitter, the second light emitter, nor the second light emitters of the present claim are recited as being so arranged that light emitted by the light emitter of parent claim 1 nor the first light emitter, the second light emitter, nor the second light emitters of the present claim is configured to reach the light sensor from different directions.
Further, is unclear what applicant has defined as meaning of “different directions” and how differently the or separately the first light emitter and the second light emitter must be arranged in order for the light to functionally be determined to originating from a “different” direction from one another. E.g., it is unclear if the first light emitter and the second light emitter are each arranged at a separate axial direction with respect to the longitudinal axis of the earpiece or angled when recessed into each respective cradle housing the first light emitter and the second light emitter on the earpiece. In absence of a defined limitation, the limitation has been interpreted under the broadest reasonable interpretation to mean any axial or degree of difference approximated in any unit known in the geometrical arts.
Claim 5 has been amended to recite “an emitter in the cradle to provide an emitter-and-sensor pair” in lines 1, 3, which renders the claim indefinite because it is unclear how a given emitter being placed in a cradle “provides” both functionally and structurally (physically) a “pair” with a given sensor, and it is unclear if the sensor to which any of the prior recited emitters is required to be a specific sensor in order to “pair”. It is unclear if the emitter and the cradle in which the emitter is recited as being “in” present claim 5 are the same emitter and the same cradle recited in parent claim 1, on which claim 5 is dependent, as claim 1 recites that the light emitter and the light-sensor are spaced apart circumferentially.
It is also unclear, to whom or to what structure the “emitter-and-sensor pair” is provided to. Similarly, it is unclear how “the nozzle” is both functionally and structurally (physically) “provided”, and by what structure or mechanism or process, a plurality of other emitter-and-sensor pairs in each a respective cradle.
Claims 6 is also rejected for reciting the same and/or limitations outlined above.
Claim 6 recites the limitations "the two sensors" and "the two groups" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. Claim 6, nor parent claim 1, on which claim 6 depends, prior recite “two sensors” or “groups”.
Further, claim 6 has been amended to recites “…to provide an emitter-and-sensors group”, “the nozzle is provided with a plurality of such a group, each group in a respective cradle” and “any one of the two sensors in a group” in lines 2-7, which renders the claim indefinite because it is unclear how a given emitter being placed in a cradle “provides” both functionally and structurally (physically) a “pair” with a given “another” sensors, and it is unclear what defines a given sensor as being “another” sensor, and how “another” sensor is structurally and functionally paired with another sensor and what also both structurally and functionally defined how a group is formed between these structures.
It is also unclear if the light emitter and the light sensor in parent claimed 1 are included in any of the “emitter-and-sensors” group. It is unclear what applicant meant to recite by reciting that the nozzle is “provided” with a plurality of “such a group”, as the term “provided” is rejected for the similar reasons outlined the paragraph immediately above. It is also appears, although it is unclear, that applicant intends to claim intended use by using the phrase “such a”, as there is no active step recited claiming an active forming or pairing of the elements cited in the claim, and by what mechanism.
It is also unclear if the group applicant recites in which “any one of the two sensors is in”, is the same type of group cited above, or a different type of group or grouping of elements, being structurally and/or functionally. As discussed early in the rejection of claim 6, it is not clear what defines a given group as being “another”, and how “another” group is structurally and functionally different or separate from any of the claimed “groups” or “groupings”.
Claim 9 has been amended to recites “…is absorptive of a frequency of the light which the light sensor detects” in lines 1-3, which renders the claim indefinite because it is unclear if applicant meant to a frequency of light which the light-sensor detects. It is also appearing, although it is unclear, that applicant is reciting intended use as there is no positive recitation of an active step of detection of a frequency of light by the light-sensor. Therefore, the limitation has been interpreted as intended use.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Liao et al. (US20120116231, hereinafter “Liao”), in view of LeBoeuf et al. (US20210393146, hereafter “LeBoeuf”).
Regarding claim 1, Liao discloses an earpiece comprising:
a nozzle configured to be inserted into an ear canal (abstract, [0029], [0032] the earplug 10 includes housing 200 that is inserted into the ear canal);
a light emitter and a light-a sensor ([0045], FIG. 7, including a light source 50 and light receiver 70) spaced apart on the nozzle circumferentially ([0045], FIGS. 1, 7, circumferentially shaped housing 200, see FIG. 1, has light sensors and emitters spaces apart circumferentially as illustrated in FIG. 7);
the light sensor being in a cradle made into the surface of the nozzle ([0045], FIG. 7, see receiver 70 in groove 220 in FIG. 7); but does not explicitly disclose the cradle limiting the field-of-view of the light-sensor.
However, in the same field of endeavor, LeBoeuf teaches the cradle limiting the field-of-view* of the light-sensor ([0094], FIG. 12, the optical emitter 402 and detectors 404 may be isolated by an optical blocking material in respective cradles seen in FIG. 12 to prevent unwanted optical signals from triggering the optical detectors).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the earpiece disclosed by Liao with the cradle limiting the field-of-view of the light-sensor as taught by LeBoeuf in order for the optical energy reaching the optical detector may contain a greater ratio of physiological information with respect to optical scatter ([0078] of LeBoeuf).
*For the purposes of examination, the limitation has been defined as outlined in by the applicant to mean the light sensor in the cradle as the cradle protects the sensor from detecting light which reaches the sensor from a predetermined, undesirable angle (see [0008] of the specification).
It should be noted, that the limitations of “the light sensor being in a cradle made into the surface of the nozzle” is considered a functional limitation of the device; the manner of operating the device does not differentiate an apparatus/device claim from the prior art; See "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, the device of Liao as modified, would be capable of performing all the functions as recited.
Regarding claim 2, Liao substantially discloses all the limitations of the claimed invention, specifically, Liao discloses wherein:
the nozzle comprises a speaker ([0029], FIG. 1, the ear-plug type earphone produces sound using the plug head and front housing 200 is an audio housing, therefore, one of skill in the art of electrical arts, would understand that this earphone would include components known to produce sound).
Regarding claim 3, Liao, in view of LeBoeuf, substantially discloses all the limitations of the claimed invention, specifically, Liao discloses wherein:
the emitter is in a cradle made into the surface of the nozzle ([0045], FIG. 7, see emitter 50 in groove 220 in FIG. 7), and specifically, LeBoeuf discloses the cradle limiting the field of projection of the emitter ([0094], FIG. 12, the optical emitter 402 and detectors 404 may be isolated by an optical blocking material in respective cradles seen in FIG. 12 to prevent unwanted optical signals from triggering the optical detectors).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the earpiece disclosed by Liao with the cradle limiting the field of projection of the emitter as taught by LeBoeuf in order for the optical energy reaching the optical detector may contain a greater ratio of physiological information with respect to optical scatter ([0078] of LeBoeuf).
It should be noted, that the limitations of “the emitter is in a cradle made into the surface of the nozzle” and “the cradle limiting the field of projection of the emitter” are considered functional limitations of the device; the manner of operating the device does not differentiate an apparatus/device claim from the prior art; See "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, the device of Liao as modified, would be capable of performing all the functions as recited.
Regarding claim 7, Liao, in view of LeBoeuf, substantially discloses all the limitations of the claimed invention, specifically, Liao discloses further comprising:
an outer portion of the nozzle ([0030], FIGS. 1, 7, see outer portion of 200 being on the external side, at openings of the cradles 220); and
the outer surface of the sleeve is made of a material having the same refractive index* as the material filling up the sleeve ([0030], FIGS. 1, 7, the nozzle, both inner and outer portions are made of rigid plastic, therefore, they would have the same refractive index); and specifically, LeBoeuf discloses that the outer portion is a sleeve that is over the nozzle ([0010] sensor region of a monitoring apparatus includes a cover/sleeve that is detachably secured to the sensor region).
*The limitation has been interpreted as described in the specification to refer to a transparent material in [0085].
It should be noted, that the limitations of “a sleeve over the nozzle”, “the outer surface of the sleeve is made of a material having the same refractive index”, and “the material filling up the sleeve” are considered functional limitations of the device; the manner of operating the device does not differentiate an apparatus/device claim from the prior art; See "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, the device of Liao as modified, would be capable of performing all the functions as recited.
Claim(s) 4-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Liao, in view of LeBoeuf, as applied to claim 1 above, further in view of Leussler et al. (US20170311887, hereafter “Leussler”).
Regarding claim 4, Liao substantially discloses all the limitations of the claimed invention, specifically, Liao discloses wherein:
the emitter is a first emitter ([0045] see first light emitter 50 of a plurality of emitters 50 in FIG. 7);
the ear piece further comprising a second emitter ([0045] see second light emitter 50 of a plurality of emitters 50 in FIG. 7);
the second emitter and the light sensor spaced apart on the nozzle circumferentially ([[0045], FIGS. 1, 7, circumferentially shaped housing 200, see FIG. 1, has light sensors and emitters, including the second light emitter, spaced apart circumferentially as illustrated in FIG. 7); but does not explicitly disclose the first emitter and second emitters as being positioned such that light emitted by the two emitters reaches the light sensor in from different directions.
However, in the same field of endeavor, Leussler teaches the nozzle is provided the first emitter and second emitters positioned such that ([0089], FIG. 3) light emitted by the two emitters reaches the sensor in from different directions ([0089]-[0091] the optical axis 66 of the optical emitter 64 and an optical axis 70 of the optical sensor 68 intersect in a distance to the integrated unit 74, for emitters and sensors 1-4 as depicted in FIG. 3).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the earpiece disclosed by Liao the nozzle is provided the first emitter and second emitters positioned such that light emitted by the two emitters reaches the sensor in from different directions as taught by Leussler in order to provide output signal is indicative of a physiological parameter of the patient and serves as a basis for determining the physiological parameter of the patient ([0092] of Leussler).
It should be noted, that the limitations of “the second emitter and the light sensor spaced apart on the nozzle circumferentially”, “the first emitter and second emitters as being positioned”, and “such that light emitted by the two emitters reaches the light sensor in from different directions” are considered functional limitations of the device; the manner of operating the device does not differentiate an apparatus/device claim from the prior art; See "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, the device of Liao as modified, would be capable of performing all the functions as recited.
Regarding claim 5, Liao substantially discloses all the limitations of the claimed invention, specifically, Liao discloses further comprising:
an emitter in the cradle to provide an emitter-and-sensor pair (claim 12, the vital signs measurement device comprises a light emitter and a light measuring sensor received in the cradle); and
the nozzle is provided with a plurality of other emitter-and-sensor pairs each in respective cradles (FIG. 7, see plurality of cradles 220 formed toward the central longitudinal axis of the nozzle 200); but does not explicitly disclose the sensor in any one of the emitter-and-sensor pairs is configured to sense light emitted from an emitter in another one of the emitter-and-sensor pairs.
However, in the same field of endeavor, Leussler teaches the sensor in any one of the emitter-and-sensor pairs is configured to sense light emitted from an emitter in another one of the emitter-and-sensor pairs ([0089], FIG. 3, optical axes 70, 66 intersect at receivers 74i).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the earpiece disclosed by Liao with the sensor in any one of the emitter-and-sensor pairs is configured to sense light emitted from an emitter in another one of the emitter-and-sensor pairs as taught by Leussler in order to provide output signal is indicative of a physiological parameter of the patient and serves as a basis for determining the physiological parameter of the patient ([0092] of Leussler).
It should be noted, that the limitations of “an emitter in the cradle to provide an emitter-and-sensor pair” and “the nozzle is provided with a plurality of other emitter-and-sensor pairs each in respective cradles”, are considered functional limitations of the device; the manner of operating the device does not differentiate an apparatus/device claim from the prior art; See "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, the device of Liao as modified, would be capable of performing all the functions as recited.
Regarding claim 6, Liao, in view of Leussler, substantially discloses all the limitations of the claimed invention, specifically, Liao discloses further comprising:
an emitter and another sensor in the cradle of the sensor to provide an emitter- and-sensors group (see 22a, 22b, 22c);
the nozzle is provided with a plurality of such a group, each group in a respective cradle ([0008] each opening/cradle having a light emitter and a light sensor, there being a plurality of cradles each having such an arrangement of light emitter and light sensor); but does not explicitly disclose any one of the two sensors a group is configured to sense light emitted from an emitter in another one of the groups.
However, in the same field of endeavor, Leussler teaches any one of the two sensors a group is configured to sense light emitted from an emitter in another one of the groups ([0089], FIG. 3, optical axes 70, 66 intersect at receivers 74i).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the earpiece disclosed by Liao with any one of the two sensors a group is configured to sense light emitted from an emitter in another one of the groups as taught by Leussler in order to provide output signal is indicative of a physiological parameter of the patient and serves as a basis for determining the physiological parameter of the patient ([0092] of Leussler).
It should be noted, that the limitations of “an emitter and another sensor in the cradle of the sensor to provide an emitter- and-sensors group”, “the nozzle is provided with a plurality of such a group” “each group in a respective cradle”, and “light emitted from an emitter of another one of the groups” are considered functional limitations of the device; the manner of operating the device does not differentiate an apparatus/device claim from the prior art; See "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, the device of Liao as modified, would be capable of performing all the functions as recited.
Regarding claim 9, Liao substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein: a wall of the cradle is absorptive of a frequency of the light which the light sensor detects.
However, in the same field of endeavor, Leussler teaches wherein:
a wall of the cradle is absorptive of a frequency of the light which the light sensor detects ([0095] the head coil and surrounding surfaces are covered with a surface material that is highly absorptive with regard to the electromagnetic radiation [frequency of light] emitted by the optical emitters).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the earpiece disclosed by Liao with the wall of the cradle is absorptive of a frequency of the light which the light sensor detects as taught by Leussler so to not affect the measurement of the optical sensor by reflected patterns ([0095] of Leussler).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SHAFQAT whose telephone number is (571)272-4054. The examiner can normally be reached Monday-Friday 9:30AM-5:30PM MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.S./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798