DETAILED ACTION
This office action is responsive to original claims filed on 12/16/2024. Presently, Claims 1 - 10 remain pending.
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 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a communication unit configured for communicating output signal(s) from the laser to the controller” in Claim 4.
A review of the Specification discloses that the corresponding structure for the “communication unit” is formed of “a wired or wireless communication unit. Examples of wireless communication units include units incorporating Bluertooth technology, 3G, 4G, 5G, 6G technology, Wifi technology, Near Field Magnetic Induction, ultrasonic and infrared communication or another wireless technology. Examples of wired communication units may include cable based technology including USB technology” (Page 22, Lines 11-14).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities:
Claim 1, Line 5, recites “emit radiation”, and Line 7, “detect radiation”, which, for purpose of better differentiation, should be changed to “emit a first radiation” and “detect a second radiation”, respectively.
Claim 6, Line 2, recites “around the wrist”, which should be changed to “around a wrist”.
Appropriate correction is required.
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 1-10 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, Line 9, recites “… detect radiation emitted … and radiation received from the tissue …”. It is unclear whether the recited “radiation emitted” is emitted from the “laser” in Line 4 OR from any source, and whether the recited “radiation received from the tissue” is emitted from the “laser” in Line 4 and then reflected at the surface of the tissue OR any radiation received from the tissue. For present purposes of examination, Examiner interprets the recited “radiation emitted” as “radiation emitted from the laser”, and “radiation received from the tissue” as “radiation reflected from the tissue”. The same rejection and interpretation also apply to Claim 10.
Claim 2, Lines 2-3, recites “emit radiation”. It is unclear whether the recited “radiation” refers to the same radiations set forth in Claim 1. For present purposes of examination, Examiner interprets the recited “radiation” to refer to the emitted “radiation” in Line 5 of Claim 1.
Claim 3, Lines 2-3, recites “comprising operating a system in accordance with claim 1 to generate output signal(s)”. Claim 1 does not set forth any limitation on operating or using the system. For present purposes of examination, the recited content is interpreted as “comprising determining the physiological parameter using the system of claim 1”.
Claims 4-9 are also rejected under 35 U.S.C. 112(b) because they inherit the indefiniteness of the claim(s) they respectively depend upon.
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.
Claims 1, 3-6 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (US 20220099431 A1; hereafter Chen), in view of Boggett et al (US 6173197 B1; hereafter Boggett).
With regard to Claim 1, Chen discloses a system (the self-mixing interferometry system 360) for determining a physiological parameter (a user's heart rate; blood oxygenation level; blood pressure) of a body comprising blood perfused tissue (Chen, Para 0094; “In the self-mixing interferometry system 360, a property of sub-surface features underneath the target 370 may be measured. … a user's heart rate; blood oxygenation level; blood pressure; and so on may be determined. … Objects below the target 370 may include blood vessels, tissue, and so on.”), the system comprising:
a housing (Chen, Para 0154; “an electronic watch 800b including … a housing 806b”; further in Para 0155, Chen discloses “Any of the self-mixing interferometry sensors, and associated optics and/or circulators, discussed with reference to FIGS. 1A-7 may be integrated with the mobile phone 800b …”),
a laser provided at or in the housing, configured to emit radiation to a surface of the tissue (Chen, Fig. 8B shows that a self-mixing interferometry sensor 802b is provided at the housing 806b. Further in Para 0156; “self-mixing interferometry sensor 802b may be directed to emit light to a point on a user's skin”),
a radiation detector (photodetector 136) integrated with the laser (Chen, Para 0059; “A photodetector 136 may be integrated with the VCSEL 122 …”), the radiation detector configured to detect radiation and to create output signal(s) (a bias current IPD) related to the detected radiation (Chen, Para 0060; “A current monitor 134 may measure a bias current IPD of the photodetector 136 …”), and configured to simultaneously detect radiation emitted to the surface of the tissue (a portion of the laser light downwards into the photodetector 136) and radiation received from the tissue (alterations resulting from a self-mixing interference operation) at a fixed distance from the laser or the tissue (Chen, Para 0060; “… the VCSEL 122 may emit a portion of the laser light downwards into the photodetector 136 in addition to the transmitted beam of light 126. Any alterations in the light emitted by the VCSEL 122, such as alterations resulting from a self-mixing interference operation, may additionally be input to the photodetector 136.” Here “alterations resulting from a self-mixing interference operation” are caused by reflected light from the tissue so is to detect the radiation received from the tissue.), and
a controller (Chen, Para 0067; “… a system 250 that may implement a self-mixing interferometry operation and associated analyses”) configured to receive output signal(s) from the radiation detector (Chen, Para 0067; “… a signal 262 (e.g., a combination of the triangle-modulated laser bias current 252 and a self-mixing signal). The signal 262 may have been measured by a photodetector …”. Fig. 2B of Chen shows that the signal 262 is received by the system 250.) and to determine the physiological parameter from the output signal(s) (Chen, Para 0094; “a displacement or movement of blood flowing through veins may be measured by self-mixing interferometry operations so that, for example, a user's heart rate; blood oxygenation level; blood pressure; and so on may be determined.”), and configured to determine a relative movement between the tissue and the laser with integrated radiation detector from at least a portion of the output signal(s) (Chen, Para 0072; “The frequency domain analysis may isolate signals corresponding to a change in an operational parameter of the VCSEL 260 and may be used to measure real-world events (e.g., a gesture, a distance between a target and a VCSEL, a speed of the target or the VCSEL, and so on).”) (Chen, Para 0151 shows that the mobile phone 800a, which is based on the self-mixing interferometry sensor, is able to determine both motion of a user and sub-dermal physiologic parameter; “The self-mixing interferometry sensor 802a may utilize sensed self-mixing signals to determine the presence or motion of a part of a user (e.g., a user's finger) … a user may place her finger on top of the self-mixing interferometry sensor 802a where sub-dermal measurements (e.g., a heartbeat measurement) may be collected.”).
Chen does not clearly and explicitly disclose wherein the system comprises an output splitter, configured to split the output signal(s) in a high-frequency portion, related to a Doppler shift and amplitude modulation caused by the velocity of the blood, and a low-frequency portion, related to an amplitude modulation caused by the relative movement between the laser with integrated radiation detector and the tissue, and the controller is configured to determine the physiological parameter from the high-frequency portion and relative movement from the low-frequency portion.
Boggett in the same field of endeavor discloses wherein the system comprises an output splitter (Boggett, Column 3, Lines 53-55; “Spectral analysis of the digitised Doppler signal, blood flow calculation and movement artefact detection and removal are performed”. Specifically, Boggett splits the output signal by computing power spectral density on a low-frequency and a high-frequency range respectively; Column 6, Lines 31-35; "In an example of a noise reduction algorithm illustrated here, two parameters are calculated together with the blood flux. One is the current value of the ω weighted power density (LP) over the low frequency band (e.g. 20 Hz-3 KHz) … "; Column 7, Lines 29-30; "HP is the ω weighted power spectral density for the high frequency band e.g. 3 KHz to 15 KHz."), configured to split the output signal(s) in a high-frequency portion, related to a Doppler shift and amplitude modulation caused by the velocity of the blood (Boggett, Column 6, Lines 25-27; “… blood flow increases which mainly changes over higher frequency range …”), and a low-frequency portion, related to an amplitude modulation caused by the relative movement between the laser with integrated radiation detector and the tissue (Boggett, Column 6, Lines 22-25; “… by calculating the change of the spectral power in a low frequency band (e.g. 20 Hz-3 KHz), it is possible to detect movement artefact which causes a sudden increase in the power density on the lower frequency range …”), and the controller is configured to determine the physiological parameter from the high-frequency portion and relative movement from the low-frequency portion (the combination of disclosures by Chen and Boggett above rejects this limitation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chen, as suggested by Boggett, in order to split the output signal into high- and low-frequency portions. One of ordinary skill in the art would have been motivated to make the modification for the benefit of separating the contributions of blood flow and of body and/or sensor movement thus increasing the estimation accuracy of the blood flow (Boggett, Abstract; “By filtering movement artefact noise, the apparatus enables fast tissue blood perfusion monitoring with enhanced signal quality.”).
With regard to Claim 3, Chen and Boggett disclose a system in accordance with Claim 1 to generate output signal(s).
Chen further discloses a method (Chen, Abstract; “Methods and systems concerning non-reciprocal sensing paths for a self-mixing interferometry operation are disclosed herein.”) for determining a physiological parameter of a body comprising blood perfused tissue (Chen, Para 0094; “… a property of sub-surface features underneath the target 370 may be measured. … a user's heart rate; blood oxygenation level; blood pressure; and so on may be determined. … Objects below the target 370 may include blood vessels, tissue, and so on.”), comprising:
determining from the output signal(s), or a part thereof, a relative movement between the tissue and the laser of the system (Chen, Para 0151; “The self-mixing interferometry sensor 802a may utilize sensed self-mixing signals to determine the presence or motion of a part of a user (e.g., a user's finger).”); and
determining from the output signal(s), or a part thereof, the physiological parameter (Chen, Para 0151; “… a user may place her finger on top of the self-mixing interferometry sensor 802a where sub-dermal measurements (e.g., a heartbeat measurement) may be collected.”).
With regard to Claim 4, Chen and Boggett disclose a system for determining a physiological parameter of a body comprising a blood perfused tissue (Chen, Para 0156; “… the self-mixing interferometry sensor 802b may be focused at a point beneath a user's skin and may be configured to detect, for example, a blood flow and/or a blood oxygenation level.”) in accordance with Claim 1.
Chen further discloses a wearable (Chen, Para 0154; “FIG. 8B depicts an electronic watch 800b including a display 804b, a self-mixing interferometry sensor 802b, a housing 806b …”), comprising
the housing (a housing 806b),
the laser (Chen, Para 0058; “… a self-mixing interferometry system 120 that uses a VCSEL 122 configured to emit a beam of light 126 toward a target 130.”),
the radiation detector (Chen, Para 0059; “A photodetector 136 may be integrated with the VCSEL 122 …”), and
a communication unit configured for communicating output signal(s) from the laser to the controller (Chen, Para 0067; “… a signal 262 (e.g., a combination of the triangle-modulated laser bias current 252 and a self-mixing signal). The signal 262 may have been measured by a photodetector …”. Fig. 2B of Chen shows that the signal 262 is received by the system 250 (corresponds to the controller 6 of the application), inherently by some communication unit.).
With regard to Claim 5, Chen and Boggett disclose a wearable according to Claim 4. Chen further discloses wherein the housing is in the form of a ring or the housing is configured to be provided in an ear canal of a person (Chen, Para 0157; “FIG. 8C depicts an earbud 800c including a housing 806c …”).
With regard to Claim 6, Chen and Boggett disclose a wearable according to Claim 4. Chen further discloses the wearable being in the form of a patch or a device that can be worn around the wrist (Chen, Para 0154; “FIG. 8B depicts an electronic watch 800b …”).
With regard to Claim 9, Chen and Boggett disclose a system according to Claim 1. Chen further discloses wherein the laser is a semiconductor laser (Chen, Para 0046; “self-mixing interferometry sensors may use vertical cavity surface emitting laser (VCSEL) diodes …”. Here VCSEL is a semiconductor laser.).
With regard to Claim 10, Chen and Boggett disclose a system according to Claim 1. Chen further discloses wherein the radiation detector is a photodetector (Chen, Para 0046; “… self-mixing interferometry sensors may use … associated resonance cavity photodetectors (RCPDs), as a non-limiting example of a photodetector.”) configured to simultaneously detect radiation emitted to the surface of the body (a portion of the laser light downwards into the photodetector 136) and radiation received from the body at a fixed distance from the laser (alterations resulting from a self-mixing interference operation) (Chen, Para 0060; “… the VCSEL 122 may emit a portion of the laser light downwards into the photodetector 136 in addition to the transmitted beam of light 126. Any alterations in the light emitted by the VCSEL 122, such as alterations resulting from a self-mixing interference operation, may additionally be input to the photodetector 136.” Here “alterations resulting from a self-mixing interference operation” are caused by reflected light from the tissue, so is for detecting the radiation received from the tissue.).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Chen and Boggett, in view of Watanabe (US 20220142564 A1; hereafter Watanabe).
With regard to Claim 2, Chen and Boggett disclose a system according to Claim 1. Chen further discloses wherein the housing is configured to be provided in an ear canal (Chen, Para 00157; “The earbud 800c may be designed to fit within a user's ear …”). However, Chen and Boggett do not explicitly and clearly disclose wherein the laser is configured to emit radiation to a surface of the ear canal.
Watanabe in the same field of endeavor discloses wherein the laser is configured to emit radiation to a surface of the ear canal (Watanabe, Para 0054; “… the blood flow data may be acquired, for example, at a concha auricula, an ear canal, …”; blood flow is acquired by laser Doppler method, as disclosed in Para 0027; “Information related to the blood flow may be measured, for example, using a blood flow sensor such as a laser Doppler flowmeter …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chen and Boggett, as suggested by Watanabe, in order to emit laser to a surface of the ear canal. One of ordinary skill in the art would have been motivated to make the modification for the benefit of abundant blood supply being underneath of surface of ear canal so that measurement via ear canal is both reliable and convenient.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Chen and Boggett, in view of Eggers et al (US 20220022758 A1; hereafter Eggers).
With regard to Claim 7, Chen and Boggett disclose a system according to Claim 1, but do not explicitly and clearly disclose using the system in the detection or treatment of a condition.
Eggers in the same field of endeavor discloses using the system in the detection or treatment of a condition (Eggers discloses a similar laser-Doppler method for the detection and alerting of first responders in event of cardiac arrest. Para 0077; “… heart function sensing methods incorporated in the wearable cardiac arrest detection and alerting device detect that the measured heart function parameters (e.g., heart rate, blood flow rate, blood pressure, endogenous electrical signals generated by the heart) …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chen and Boggett, as suggested by Eggers, in order to use the system in detecting or treating a condition. One of ordinary skill in the art would have been motivated to make the modification for the benefit of timely detection of an urgent disease such as cardiac arrest so that proper treatment can be provided (Eggers, Para 0011; “The present disclosure overcomes the critical need to immediately alert potential first responders … prior to the arrival of professional emergency medical services by detecting that a cardiac arrest has occurred, …”).
With regard to Claim 8, Chen and Boggett disclose a wearable according to Claim 4, but do not explicitly and clearly disclose using the wearable in the detection or treatment of a condition.
Eggers in the same field of endeavor discloses using the wearable in the detection or treatment of a condition (Eggers discloses a similar laser-Doppler method for the detection and alerting of first responders in event of cardiac arrest. Para 0077; “… heart function sensing methods incorporated in the wearable cardiac arrest detection and alerting device detect that the measured heart function parameters (e.g., heart rate, blood flow rate, blood pressure, endogenous electrical signals generated by the heart) …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Chen and Boggett, as suggested by Eggers, in order to use the wearable in detecting or treating a condition. One of ordinary skill in the art would have been motivated to make the modification for the benefit of timely detection of an urgent disease such as cardiac arrest so that proper treatment can be provided (Eggers, Para 0011; “The present disclosure overcomes the critical need to immediately alert potential first responders … prior to the arrival of professional emergency medical services by detecting that a cardiac arrest has occurred, …”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI ZHANG whose telephone number is (571)272-7172. The examiner can normally be reached Monday-Friday 8am-5pm E.T..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.Z./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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