DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment to the claims filed 17 September 2025 has been entered. Claim(s) 1-9 is/are currently amended. New claim(s) 10-16 has/have been added. Claim(s) 1-16 is/are pending.
Rejections Withdrawn
Rejections under 35 U.S.C. 101 and/or 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 13, 16 and claims dependent thereon is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 13, Applicant discloses a single embodiment in which two or more optical receivers are interposed between a substrate and the light guide plate (Fig. 14 and corresponding description thereof). Applicant discloses, in said embodiment, light emitting units, a light guide plate and light receiving units are provided on the same surface of a substrate (Fig. 14; ¶ [0048]). However, claim 10, on which claim 13 depends, requires the optical receivers to be arranged on a second surface, opposite to the first surface on which the light emitting elements are arranged. Accordingly, Applicant fails to disclose an embodiment comprising the arrangement as recited in claim 13.
Regarding claim 16, Applicant discloses, "Therefore, in the biological information acquisition device 100, the modulation unit 110 modulates the biosignals (S1, S2) at a specific frequency. The specific frequency can be selected from a band that is not affected by pulse components and noises such as body movement artifacts in the biosignals (S1, S2)" (¶ [0054]). Claim 16 recites the "specific frequency component," which is a recited in claim 1 as a component of the biosignals, is selected from the recited band. Further, claim 1 does not require a "specific frequency component" based on which the intensity of signals is adjusted to be related in any manner to the "specific frequency" at which the light emitting element(s) is/are dimmed. Accordingly, while Applicant discloses the specific frequency at which a light emitting element(s) is dimmed may be selected "from a band that is not affected by pulse components and noises such as body movement artifacts in the biosignals," Applicant does not appear to disclose "the specific frequency component [of the biosignals] is selected from a frequency band and is predetermined as not being affected by body movement artifacts of the living body," as recited in claim 16.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 8-9 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0306487 A1 (previously cited, "Crowe") in view of US 2012/0253153 A1 ("Trumble"); or alternatively, over Crowe in view of US 2016/0302706 A1 (previously cited, "Richards") and Trumble.
Regarding claims 1, 8-9 and 14, Crowe discloses and/or suggests a biological information acquisition system comprising:
a biometric sensor (reflectance probe 700) comprising a substrate (substrate 701, e.g., PCB as described in ¶ [0144]); one or more, including at least two, light emitting elements (light emitting devices, e.g., LEDs, 602, 702, etc.); two or more optical receivers (photodiode 604, 704, which may be an array of detectors, e.g., ¶ [0142]), wherein the two light emitting elements and the two or more optical receivers are arranged on a surface of the substrate (e.g., Fig. 7; ¶ [0144]); and
a biological information acquisition device comprising a non-transitory recording medium, e.g., a memory, configured to store instructions and at least one processor configured to execute the instructions to perform a biological information acquisition method (¶ [0184] microprocessor comprising and executing a digital signal processing algorithm), said method comprising:
dimming the one or more light emitting elements at a specific frequency (e.g., ¶¶ [0030]-[00365] one or more light sources that are driven by one or more modulators such that the output intensity of each light source varies as a function of a modulation signal at a modulation frequency; ¶ [0145] the light source is excited at a given frequency and amplitude by a modulating carrier from the driver circuit 601; etc.);
receiving biosignals based on light received from the living body by two or more optical receivers (e.g., ¶¶ [0030]-[00365] one or more detectors for receiving light from the target object and generating one or more electrical outputs as a function of the intensity of received light; ¶ [0147] light incident on the photodiode 604 generates an analog current that is converted by current-to-voltage converter 605, e.g., transimpedance amplifier 800; etc.); and
adjusting an intensity of at least one of the biosignals based on a specific frequency component of the at least one of the biosignals (e.g., ¶¶ [0030]-[00365] a plurality of demodulators each for receiving one or more of the electrical outputs and producing a demodulated output representative of the modulation signal of one of the modulated light sources and any sidebands thereof, to thereby produce a plurality of demodulated outputs corresponding to the plurality of light sources and/or plurality of detectors and/or means for generating, from the demodulated outputs, PPG signals indicative of blood volume as a function of time and/or blood composition for each of the demodulator outputs; Fig. 11; ¶¶ [0153]-[0154] each measured value of each modulated signal (i.e., output of the current-to-voltage converter 605, or a filtered version thereof, e.g., ¶¶ [0147]-[0149]), is multiplied with a corresponding-in-time value of the demodulator local oscillator signal that has a frequency equal to the modulating carrier frequency).
Crowe discloses/suggests the specific frequency component is predetermined to not be affected by noise that may be detected by the receivers (e.g., ¶ [0012]), and discloses said specific frequency component is utilized to adjust to intensity of the signal received by the receivers by demodulating said signal based on the modulation frequency, as noted above.
Alternatively/Additionally, the claim does not require the "specific frequency component" to be related in any manner to the "specific frequency" at which the light emitting element(s) is/are dimmed, and Crowe discloses the biosignal output by each detector comprises an AC and DC component (e.g., ¶¶ [0165]-[0166]). Richards discloses/suggests a method comprising, inter alia, receiving biosignals based on light received from a living body by two or more optical receivers (e.g., Abstract, light detector(s) to generate an electrical signal(s) while the light emitter emits light(s), e.g., ¶ [0142] raw PPG signal(s)); and adjusting an intensity of the biosignal acquired from each of the optical receivers based on a specific frequency component for the biosignal (e.g., ¶ [0142] a signal, e.g., DC offset, may be subtracted from the raw PPG signal). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method performed by the system/device of Crowe to comprise adjusting an intensity of the biosignal acquired from each of the optical receivers based on a specific frequency component for the biosignal (e.g., a DC component thereof) as taught and/or suggested by Richards in order to increase the gain or amplification of the PPG signal that contains heart rate (e.g., PPG AC component) (Richards, ¶ [0142]).
Crowe/Crowe as modified does not expressly disclose the biometric sensor is a stick-on biometric sensor configured to be stuck-on to a living body by an adhesive sheet of the stick-on biometric sensor, or across the surface of the substrate, each of the two light emitting elements are between ones of the two or more optical receivers. However, Crowe does disclose the probe operates in a reflection or reflectance mode, allowing measurements to be performed on almost any area of tissue (e.g., ¶ [0008]), and specifically discloses the probe may be placed on, e.g., the forehead (¶¶ [0163]-[0164]).
Trumble discloses a comparable biometric sensor (Figs. 6, 8, etc.; physiological sensor 26, 26A-D, etc.) comprising a substrate (flexible substrate 202); one or more, including at least two, light emitting elements (emitter(s) 30, 30A-C) and two or more optical receivers (photodetector array 32), wherein, across the surface of the substrate, each of the two light emitting elements are between ones of the two or more optical receivers (e.g., Figs. 8-9), and wherein the biometric sensor is a stick-on biometric sensor configured to be stuck on to a living body by an adhesive sheet of the stick-on biometric sensor (¶ [0041], ¶ [0046], etc., where bandage 204 may include an affixation element commonly used by one skilled in the art, such as an adhesive, to affix the sensor to a patient 104),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Crowe with the biometric sensor being a stick-on biometric sensor configured to be stuck on to a living body by an adhesive sheet of the stick-on biometric sensor, wherein each of the two light emitting elements are between ones of the two or more optical receivers across the surface of the substrate, as taught and/or suggested by Trumble in order to facilitate placing/securing the sensor on/to almost any area of tissue of the patient for subsequent monitoring (Crowe, ¶¶ [0163]-[0164]; Trumble, ¶ [0041], ¶ [0046]; etc.), and to ensure the receivers adequate light for the generation of signals (Trumble, ¶ [0048]).
Regarding claim 2, Crowe as modified discloses/suggests the method comprises dimming a plurality of the light emitting elements emitting light at the same wavelength at the same frequency (e.g., ¶ [0107] light source modulated at a selected frequency and amplitude, wherein each light source can consist of one or more optical emitters that emit light at a single, given wavelength).
Regarding claim 3, Crowe as modified discloses/suggests the method comprises dimming a plurality of the light emitting elements emitting light at different wavelengths at different frequencies (e.g., ¶ [0107] plurality of light sources emitting light at two more different wavelengths, wherein each light source is modulated at a selected frequency and amplitude, which may be different for each light source).
Regarding claim 4, Crowe as modified discloses/suggests the method comprises dimming a plurality of the light emitting elements emitting light at the same wavelength at different frequencies (e.g., ¶ [0117] each pixel corresponds to a respective, independently driven, light source, so that different modulation frequencies could be used for each pixel). Paragraph [0117] of Crow is understood to encompass, for each pixel, providing an independently driven light source that emit light at the same wavelength as the remaining light sources. Such an interpretation appears to be consistent with the surrounding disclosure of Crowe, which appears to indicate and/or suggests using multiple wavelength light sources optional, but not necessarily required (e.g., ¶ [0118] producing spatial blood constituent measurements "when more than one wavelength is used").
Alternatively/Additionally, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the device, or method executed by the device, of Crowe with dimming a plurality of light emitting elements that emit light at the same wavelength at different frequencies because Applicant has not disclosed that the light modulation as claimed provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant appears to disclose the different light modulation methods or configurations as recited in each of claims 2-4 as suitable alternatives (e.g., ¶ [0032]). As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the light source modulation method(s) clearly disclosed by Crowe (e.g., ¶ [0107]) because either arrangement permits acquiring bio-signals (e.g., PPG signals) having reduced artifact and/or noise.
Claim(s) 5-7 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crowe in view of Trumble (or Crowe in view of Richards and Trumble) as applied to claim(s) 1 above, and further in view of US 2017/0340257 A1 (previously cited, "Aung").
Regarding claims 5-7 and 15, Crowe as modified discloses/suggests the limitations of claim 1, as discussed above, and further teaches/suggest the method comprises measuring at least one of a heart rate and a blood flow rate of the living body based on the adjusted biosignals (e.g., ¶ [0001], ¶ [0119] measuring/extracting pulse rate; ¶ [0163] pulse rate). Crowe further discloses the adjusted biosignals provide a maximized signal-to-noise ratio, such that parameters can be extracted from the adjusted biosignals with greater reliability (¶ [0182]). Crowe as modified does not expressly teach the method comprises analyzing a mental or physical condition of the living body based on the adjusted biosignals and/or estimating an emotion of the living body based on the adjusted biosignals.
Aung discloses/suggests a method comprising, inter alia, analyzing a mental condition (e.g., emotion) of the living body based on a received biosignal (e.g., bio-signal obtained by signal sensing module 402) (e.g., ¶ [0011]). The examiner notes Applicant additionally acknowledges Aung discloses this feature (e.g., ¶ [0003] where Applicant cites PTL 1, which is a Japanese application in the same patent family as Aung, as an exemplary disclosure of estimating a mental state, e.g., emotion, from a biosignal, such as pulse).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method performed by the device/system of Crowe to comprise analyzing a mental condition of the living body, such as emotion, based on the adjusted biosignals as taught/suggested by Aung, wherein the accuracy of said analysis is increased due to the biosignals being adjusted (Crowe, e.g., ¶ [0182]), in order to enable an individual to be aware of his/her emotional state so that necessary actions may be taken to maintain his/her overall physical and mental well-being (Aung, ¶ [0007]).
Claim(s) 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crowe in view of Trumble (or Crowe in view of Richards and Trumble) as applied to claim(s) 1 above, and further in view of US 2017/0354335 A1 ("Bower").
Regarding claims 10-12, Crowe as modified discloses/suggests the limitations of claim 1, and discloses/suggests the stick-on biometric sensor comprises a substrate and may comprise at least two light emitting elements, as discussed above. Crowe as modified does not disclose the one or more light emitting elements are arranged on a first surface of the stick-on biometric sensor, the two or more optical receivers are arranged on a second surface, opposite to the first surface, of the stick-on biometric sensor, and when the stick-on biometric sensor is stuck-on to the living body, the first surface is facing away from the living body and the second surface is facing towards the living body.
Bower discloses a stick-on biometric sensor (e.g., Fig. 5; layer 6 comprises a skin safe adhesive configured to attach the apparatus 100 to the skin 7 of the user, e.g., Fig. 1) comprising two light emitting elements (at least one light source 2); two or more optical receivers (at least one photodetector 3); a substrate arranged between the two light emitting elements and the two or more optical receivers (substrate 11), wherein the light emitting elements are arranged on a first surface of the stick-on biometric sensor (e.g., of substrate 11) (Fig. 5, where light source(s) 2 is arranged on one surface of substrate 11 when laminate layers are assembled), and the two or more optical receivers are arranged on a second surface, opposite to the first surface, of the stick-on biometric sensor (Fig. 5, where photodetector(s) 3 is arranged on the opposite surface of substrate 11 when laminate layers are assembled), and when the stick-on biometric sensor is stuck-on to the living body, the first surface is facing away from the living body and the second surface is facing towards the living body (Fig. 5, since layer 6 is adapted to contact skin (e.g., Fig. 1), the surface of substrate 11 having light source(s) 2 thereon faces away from the living body); and a light guide plate arranged on the first surface and between the two light emitting elements (first layer 4), wherein the light guide plate is configured to, when the stick-on biometric sensor is stuck-on to the living body, direct scattered light from the two light emitting elements towards the living body (e.g., ¶ [0038] layers 4 and 5 are configured to guide the light from the at least one light source 2 to the blood perfused tissue of the person using the apparatus).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bower with the above-noted stick-on biometric sensor arrangement taught and/or suggested by Bower in order to provide a sensor suitable and/or convenient to be worn for prolonged time periods (Bower, ¶ [0003]) and/or as a simple substitution of one suitable stick-on biometric sensor arrangement for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claim 13, Crowe as modified discloses/suggests the limitations of claim 11, and discloses the stick-on biometric sensor comprises a substrate and a light guide plate as discussed above, but does not disclose the two or more optical receivers are interposed between the substrate and the light guide plate. However, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system, or stick-on biometric sensor thereof, of Crowe with the two or more optical receivers are interposed between the substrate and the light guide plate because Applicant has not disclosed that the light modulation as claimed provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, as discussed with respect to rejections under 35 U.S.C. 112(a) above, Applicant does not appear to disclose the arrangement of claim 13 at all, let alone describe a particular benefit thereof or criticality thereto. As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the stick-on biometric sensor of Crowe as modified above because either arrangement permits guiding light from the light emitting elements to the skin/tissue of the subject.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crowe in view of Trumble and Bower (or Crowe in view of Richards, Trumble and Bower) as applied to claim(s) 10 above, and further in view of US 2005/0049468 A1 ("Carlson").
Regarding claims 5-7 and 15, Crowe as modified discloses/suggests the limitations of claim 10, as discussed above, and further discloses/suggests wherein the specific frequency is selected from a band that is predetermined as not being affected by sources of artifact and/or noise (e.g., ¶ [0012]). Crowe does not expressly disclose the specific frequency is not affected by body movement artifacts of the living body, but does disclose movement artifact is often a serious problem for PPG systems (e.g., ¶ [0118]), thereby at least suggesting movement is another source of artifact and/or noise that may be present in the receiver signal. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method performed by the device/system of Crowe with the specific frequency being selected from within a band that is additional not affected by body movement artifacts in order to minimize the sensitivity of the system to additional interference from body movements (Crowe, ¶ [0011]).
Alternatively/Additionally, Carlson discloses a comparable system, wherein the selected frequency is selected from a frequency band of above ~1 kHz (e.g., ¶ [0069]), which corresponds to the only particular specific frequency value/band disclosed by Applicant (e.g., ¶ [0041]), and therefore, to the best of the examiner's understanding, meets the disclosed parameter of a being suitable specific frequency that is not affected by body movement artifacts. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method performed by the device/system of Crowe with the specific frequency being selected from within the band disclosed by Carlson, e.g., ~1 kHz, as a simple substitution of one suitable specific frequency for another to yield no more than predictable results. See MPEP 2143(I)(B).
Response to Arguments
Applicant's arguments with respect to the prior art rejections have been considered but are moot because the new ground(s) 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.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791