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 Amendment
The amendment filed on 03/16/2026 has been entered. Claims 1-8 and 10 have been amended. New claims 11-14 have been added. Claims 1-14 remain pending.
The previously raised objections for Claims 1 and 6 are withdrawn because the issues have been properly corrected.
The previously raised rejections under 35 U.S.C. 112(b) for Claims 1-10 are withdrawn because the issues have been properly corrected.
Response to Arguments
On Page 8 of Remarks, Applicant argues that, regarding amended Claim 1, reference Boggett teaches splitting an output signal by computing power spectral density on a band of 20 Hz - 3 kHz and a band of 3 kHz - 15 kHz respectively, but does not teach wherein the high-frequency portion is in a range of 10 kHz - 50 kHz or determine the physiological parameter from the portion (of 10 kHz - 50 kHz). On Pages 8-11 of Remarks, Applicant further argues that the high frequency portion in the range of 10 kHz to 50 kHz is independent of movement artefacts, so would demonstrate a “marked improvement” as compared with reference Boggett. Examiner appreciates Applicant’s detailed explanation of the issue, but respectfully disagrees. First, the high-frequency range claimed by Application and by Boggett, 10 - 50 kHz vs. 3 - 15 kHz, do have overlap in the range of 10 - 15 kHz. Second, while biologic information typically corresponds to higher frequency than movement artefacts, the respective frequency ranges of the two could very possibly overlap by some degree, so selection of a separation frequency point would be a trade-off between including more movement artefact and losing more physiologic information. As Applicant cited from Specification, various movements could output varying frequencies, such as below 10 kHz, below 5 kHz, or below 2 kHz, and all of these numbers seem to be empirical estimates. On the other hand, output signals representing blood cell velocities, as cited by Applicant, also have variable frequency intervals, such as 50 Hz - 50 kHz, 1 kHz - 45 kHz, 10 - 40 kHz, 5 - 20 kHz or the like. In view of the above, Examiner do not think that the differently selected intervals of frequency by Application as compared to the prior art would have significant advantage and thus lead to marked improvement.
On Pages 12-13 of Remarks, Applicant argues that, regarding new Claim 14, the cited art does not teach the high-frequency portion is in a frequency range of 20 kHz – 50 kHz, as required by Claim 14. Examiner respectfully disagrees. Reference Boggett teaches the limitation by showing in its Fig. 4 that the high-frequency portion can be in a range of 3 kHz – 24 kHz. More details can be found in section of 35 USC § 103.
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 the 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 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 9-14 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, the laser configured to emit a first radiation to a surface of the blood perfused 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”; Para 0046; “… self-mixing interferometry sensors may use vertical cavity surface emitting laser (VCSEL) diodes”),
a radiation detector (photodetector 136) configured to detect a second radiation, create output signal(s) (a bias current IPD) related to the detected second radiation (Chen, Para 0060; “A current monitor 134 may measure a bias current IPD of the photodetector 136 …”), and simultaneously detect radiation emitted from the laser to the surface of the blood perfused tissue (a portion of the laser light downwards into the photodetector 136) and radiation reflected from the blood perfused tissue (alterations resulting from a self-mixing interference operation) at a fixed distance from the laser or the blood perfused 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 the 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.”), the controller configured to determine a relative movement between the blood perfused tissue and the laser 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.”),
wherein the system comprises an output splitter, the output splitter configured to split the output signal(s) (Chen, Para 0072; “an FFT and tone extraction circuit 276 … 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).” Here the disclosed “circuit 276” isolates signals that correspond to different events, including a subject’s movement and a speed of a target (e.g. blood flow)).
Chen does not clearly and explicitly disclose wherein
the controller is configured to determine the physiological parameter from high-frequency portion and the relative movement from low-frequency portion of the output signal(s),
the high-frequency portion is related to a Doppler shift and amplitude modulation caused by a velocity of the blood in the blood perfused tissue,
the high-frequency portion is a portion of the output signal(s) in a frequency range of 10 kHz to 50 kHz, and
the low-frequency portion is related to an amplitude modulation caused by the relative movement between the laser and the blood perfused tissue.
Boggett in the same field of endeavor discloses wherein
the controller is configured to determine the physiological parameter from high-frequency portion and the relative movement from low-frequency portion of the output signal(s) (Boggett, Column 3, Lines 53-55; “Spectral analysis of the digitised Doppler signal, blood flow calculation and movement artefact detection and removal are performed”),
the high-frequency portion is related to a Doppler shift and amplitude modulation caused by a velocity of the blood in the blood perfused tissue (Boggett, Column 6, Lines 25-27; “… blood flow increases which mainly changes over higher frequency range …”),
the high-frequency portion is a portion of the output signal(s) in a frequency range of 10 kHz to 50 kHz (Boggett, 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”), and
the low-frequency portion is related to an amplitude modulation caused by the relative movement between the laser and the blood perfused 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 …”).
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 determine physiologic and movement information from high- and low-frequency portions respectively. 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. Chen further discloses a method comprising determining the physiological parameter using the system of Claim 1 (Chen, Abstract; “Methods and systems concerning non-reciprocal sensing paths for a self-mixing interferometry operation are disclosed herein.”; 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.”).
With regard to Claim 4, Chen and Boggett disclose a system of Claim 1. Chen further discloses a wearable (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 …”), 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 the 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 a 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 a form of a patch or a device that can be worn around a 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 the radiation emitted from the laser to the surface of the blood perfused tissue (a portion of the laser light downwards into the photodetector 136) and the radiation received from the blood perfused tissue 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.).
With regard to Claim 11, Chen and Boggett disclose a system according to Claim 1. Chen further discloses wherein the laser is a vertical-cavity surface emitting laser (VCSEL) (Chen, Para 0055; “…a self-mixing interferometry system 100 that uses a VCSEL 102 configured to transmit a beam of light 106 …”).
With regard to Claim 12, Chen and Boggett disclose the system according to Claim 11. Chen further discloses wherein the radiation detector is a photodetector configured to simultaneously detect the radiation emitted to the surface of the blood perfused 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.”) and the radiation received from the blood perfused tissue (Chen, Para 0016; “… a photodetector configured to receive a returned portion of the beam of light”; Para 0056; “… light returned back toward the VCSEL 102 may be referred to as returned light and/or returned beams of light and may include light reflected and/or scattered from the target 110 either as reflections 112 or otherwise”) at a fixed distance from the laser (Chen, Para 0064; “In FIG. 2A, the laser cavity 206 has a fixed length … The transmitted laser light 210 may travel through a feedback cavity 208 and to the target 216.”).
With regard to Claim 13, Chen and Boggett disclose the system according to Claim 12. Chen further discloses wherein the photodetector is integrated with the VCSEL (Chen, Para 0059; “A photodetector 136 may be integrated with the VCSEL 122 …”).
With regard to Claim 14, Chen and Boggett disclose the system according to Claim 1, but do not explicitly and clearly disclose wherein the high-frequency portion is a portion of the output signal(s) in a frequency range of 20 kHz to 50 kHz.
Boggett further discloses wherein the high-frequency portion is a portion of the output signal(s) in a frequency range of 20 kHz to 50 kHz (Boggett, Column 6, Lines 15-22; “FIG. 4 shows the power spectra obtained from skin with (a) and without (b) fibre movement. It can be seen that the effect of fibre movement was mainly confined to the lower part of the beat frequency spectrum associated with the blood flow signal, particularly below 3 KHz, and has less influence on the higher frequency range related to fast blood cells.” In the disclosed discussion of Fig. 4, signals with frequency below 3kHz are attributed to the effect of movement, and the “higher frequency range” corresponds to “fast blood cells”. In Fig. 4, the disclosed “higher frequency range” is shown to be from 3 kHz to 24 kHz (note that the highest frequency along the frequency axis is 24 kHz)). 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 Boggett, in order to use a higher range of frequency for measuring blood flow. One of ordinary skill in the art would have been motivated to make the modification for the benefit of increased range of measurement that covers moving blood cells of higher velocity, so as to achieve more comprehensive assessment of blood velocity profile.
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 a detection or treatment of a condition.
Eggers in the same field of endeavor discloses using the system in a 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 a detection or treatment of a condition.
Eggers in the same field of endeavor discloses using the wearable in a 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/L.Z./ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
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