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 Amendments
The amendment filed December 17, 2025 has been acknowledged and entered. Claims 31-48 and 50 remain pending in the application.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 41-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Waller (WO 2017143198).
Regarding claim 41, Waller teaches a method (Figure 3) characterizing blood flow in a subject the method comprising illuminating a blood vessel of the subject with light from a light source assembly (LEDs) electrically connected an integrated circuit (processor) (Paragraph [0028]); detecting, by a first light detector (500) of a light detector assembly of the integrated circuit, a first photoplethysmography (PPG) signal indicative of a blood flow event at a first location in the blood vessel based on a first optical signal (Paragraphs [0040]-[0041]); detecting, by a second light detector (502) of the light detector assembly of the integrated circuit, a second PPG signal indicative of a blood flow event at a second location in the blood vessel based on a second optical signal (Paragraphs [0040]-[0041]); based on (i) a time delay indicative of a propagation of the blood pulse event between the first light detector and the second light detector, and (ii) a separation between the first light detector and the second light detector, determining a characteristic of blood flow in the subject. (Paragraphs [0040]-[0041], [0044]-[0046]).
Regarding claim 42, Waller teaches in which determining a characteristic of blood flow in the subject comprises determining a pulse transit time (PTT) of the subject. (Paragraph [0005]).
Regarding claim 43, Waller teaches determining the time delay between the first optical signal and the second optical signal. (Paragraph [0041]).
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.
Claims 31-33 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Hillman (U.S. Patent Pub. No. 20100168586) (previously cited) in view of Waller (WO 2017143198).
Regarding claim 31, Hillman (U.S. Patent Pub. No. 20100168586) (previously cited) teaches (Figure 5) an integrated sensing system for characterizing blood flow in a subject (Paragraph [0013]), the integrated sensing system comprising a light source assembly (lasers 502, 504, 506, 507) comprising a light source configured to emit light of a given wavelength (Paragraph [0107]); and an integrated circuit (560) electrically connected to the light source assembly, the integrated circuit comprising; a light detector assembly (light detector array 544) comprising multiple light detectors, configured to detect the light of the given wavelength (Paragraph [0108]).
However, Hillman does not specifically teach “first and second light detectors” and while Hillman teaches a correlator (546), it does not teach “a correlator operable to correlate a first optical signal detected by the first light detector of the light detector assembly and a second optical signal detected by the second light detector of the light detector assembly, the correlator configured to: identify, by correlating features of the first optical signal and the second optical signal, that the first optical signal and the second optical signal correspond to a same blood pulse event, and determine a time delay between the first and second optical signals based on the correlation, wherein the time delay is indicative of a propagation of the same blood pulse event between the first light detect and the second light detector and is used to determine a characteristic of blood flow in the subject, wherein the first optical signal and the second optical signal are photoplethysmography (PPG) signals.”
Waller, in a related field of endeavor, teaches a blood pressure monitoring system for comprising first and second light detectors (Paragraph [0003] first and second photodiodes), and a correlator (Paragraph [0003] processor) operable to correlate a first optical signal detected by the first light detector of the light detector assembly and a second optical signal detected by the second light detector of the light detector assembly (Paragraph [0037] processor may identify and determine the PPG signal peaks with better precision, which enables the peak detection and cross-correlation algorithms implemented by the processor to be more accurate), the correlator configured to: identify, by correlating features of the first optical signal and the second optical signal, (Paragraph [0004]), that the first optical signal and the second optical signal correspond to a same blood pulse event (Paragraph [0004] The first photodiode detects a pulse wave of the user and generates a first PPG signal, and the second photodiode detects the pulse wave of the user and generates a second PPG signal. A processor coupled to the first and second photodiodes and configured to calculate the physiological characteristic of the user based on the generated first and second PPG signals and the lateral distance between the first and second photodiodes), and determine a time delay between the first and second optical signals based on the correlation, wherein the time delay is indicative of a propagation of the same blood pulse event between the first light detector and the second light detector and is used to determine a characteristic of blood flow in the subject. (Paragraphs [0040]-[0041], [0044]-[0046]).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hillman to provide “first and second light detectors” and “a correlator operable to correlate a first optical signal detected by the first light detector of the light detector assembly and a second optical signal detected by the second light detector of the light detector assembly, the correlator configured to: identify, by correlating features of the first optical signal and the second optical signal, that the first optical signal and the second optical signal correspond to a same blood pulse event, and determine a time delay between the first and second optical signals based on the correlation, wherein the time delay is indicative of a propagation of the same blood pulse event between the first light detect and the second light detector and is used to determine a characteristic of blood flow in the subject, wherein the first optical signal and the second optical signal are photoplethysmography (PPG) signals” as taught by Waller. Doing so enables continuous monitoring of a physiological characteristic of a user.
Regarding claim 32, Hillman teaches an integrated sensing system in which the light source assembly is configured to emit light of multiple wavelengths, wherein the light of the multiple wavelengths comprises the light of the given wavelength. (Paragraph [0105] light sources 502, 504, 506, and 507 emit laser light at different wavelengths).
Regarding claim 33, Hillman teaches an integrated sensing system in which the light detector assembly comprises a spectral sensor configured to detect light of multiple wavelengths, wherein the light of the multiple wavelengths comprises the light of the given wavelength. (Paragraph [0102] two-dimensional detector array, multiple linear detector arrays, or multiple linear detectors, along with a diffraction grating, prism, or other spectrally separating optical element to concurrently image multi-spectral on-axis or off-axis scattered light from a scanning spot to allow depth-resolved optical imaging or spectroscopy.)
Regarding claim 36, Hillman teaches (Figure 5) an integrated module, in which the light source assembly (lasers 502, 504, 506, 507) and the integrated circuit (560) are integrated into the integrated module. (Paragraph [0107]).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Hillman in view of Waller, further in view of Mirov (U.S. Patent Pub. No. 20170055845) (previously cited).
Regarding claim 34, Hillman as modified teaches all of the elements of the claimed invention except the integrated circuit comprising “a multiplexer connected to an output of the spectral sensor”.
Mirov, in a related field of endeavor, teaches device to optically detect hemodynamic properties of a body. (Abstract).
Mirov further teaches a multiplexer connected to an output of the spectral sensor (Paragraph [0003] a multiplexer that is electrically connected to an output of the photodetector, an output of the electrocardiogram sensor).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hillman as modified to provide in which “a multiplexer connected to an output of the spectral sensor” of Mirov. Doing so enables production electrical signals corresponding to two or more detected variables and time periods. (Paragraph [0018]-[0019]).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Hillman in view of Waller, further in view of Higgins (U.S. Patent Pub. No. 20070060810) (previously cited).
Regarding claim 35, Hillman as modified teaches all of the elements of the claimed invention except the integrated circuit comprising “a sequencer configured to control one or more of an operating frequency of the light source assembly and a sampling frequency of the light detector assembly”.
Higgins, in a related field of endeavor, teaches an apparatus for spectroscopically and continuously measuring total hemoglobin of whole blood comprising a light source and photodetector. (Paragraphs [0019]-[0020]).
Higgins further a sequencer configured to control one or more of an operating frequency of the light source assembly and a sampling frequency of the light detector assembly (Paragraph [0054] multiple light sources 18 provide discrete wavelengths that may be time multiplexed by sequencer control logic 19 to individually turn on at different times. The discrete signals are transmitted through a combined optical transmit fiber 24 into the blood 26 and reflected into a receive fiber 28. The receive fiber 28 transmits the discrete reflected signals to a single photodetector of a spectrometer 22).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hillman as modified to provide in which “a sequencer configured to control one or more of an operating frequency of the light source assembly and a sampling frequency of the light detector assembly” of Higgins. Doing so enables signals to be distinguished between the multiple light sources so the special effects of the signals may be measured. (Paragraph [0054]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Hillman in view of Waller, further in view of Kulcke (U.S. Patent Pub. No. 20160022147) (previously cited).
Regarding claim 37, Hillman as modified teaches all of the elements of the claimed invention except an integrated sensing system “in which the light source assembly comprises a light emitting diode (LED) and/or a vertical cavity surface-emitting laser (VCSEL)”.
Kulcke, in a related field of endeavor, teaches device for monitoring vital parameters of a living being, wherein broad-band light is beamed into the tissue of a living being, a spectrum of the beamed-in light is recorded, and absorption is evaluated. (Abstract).
Kulcke teaches (Figure 9) the light source assembly comprises a light emitting diode (LED) (20). (Paragraph [0058]).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hillman as modified to provide in which “the light source assembly comprises a light emitting diode” of Kulcke. Doing so provides the well-known features of energy efficient and long lasting illumination.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Hillman in view of Waller, further in view of Dalene (U.S. Patent Pub. No. 20160143537) (previously cited).
Regarding claim 38, Hillman as modified teaches all of the elements of the claimed invention except an integrated sensing system “in which the light detectors comprise photodiodes”.
Dalene, in a related field of endeavor, teaches near-infrared spectroscopy (NIRS) sensor assembly for measuring a characteristic of a biological tissue which includes a light source, at least one light detector, and a layer disposed within the sensor assembly.
Dalene teaches light detectors (24, 26) that includes one or more light detecting components (e.g., photodiodes). (Paragraph [0052]).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hillman as modified to provide in which “the light detectors comprise photodiodes” of Dalene. Doing so provides a selectively operable way to detect light signals emitted by the light source through an active region and produce and process signals representative of such detected light. (Paragraph [0052]).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Hillman in view of Waller, further in view of Martin (U.S. Patent Pub. No. 20150119654) (cited by Applicant) (previously cited).
Regarding claim 39, Hillman as modified teaches all of the elements of the claimed invention except an integrated sensing system “a mobile computing device comprising the sensing system”.
Martin, in a related field of endeavor, teaches an apparatus for obtaining at least one bodily function measurement comprising a mobile computing device comprising the sensing system. (Abstract).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hillman as modified to provide in which “a mobile computing device comprising the sensing system” of Martin. Doing so provides a device that may fit within a user's pocket or be integrated into another device that the user typically always has with them. (Paragraph [0005]).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Hillman in view of Waller, further in view of Newberry (U.S. Patent Pub. No. 20180116604) (previously cited).
Regarding claim 40, Hillman as modified teaches all of the elements of the claimed invention except “a vehicle comprising the sensing system” of claim 31.
Newberry, in a related field of endeavor, teaches a biosensor configured for integration in a vehicle and includes a PPG circuit configured to emit light at a plurality of wavelengths directed at skin tissue and obtain a plurality of spectral responses around the plurality of wavelengths of light to provide data characterizing blood flow, such as a concentration level of at least one other substance in blood flow. (Paragraphs [0014]-[0016]).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hillman as modified to provide in which “a vehicle comprising the sensing system” of Newberry. Doing so may enable measurement of the blood alcohol level of the user to a vehicle control system. (Paragraph [0015]).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Waller in view of Higgins.
Regarding claim 44, Waller teaches all of the elements of the claimed invention except the integrated circuit comprising “controlling an operating frequency of the light source assembly by a sequencer of the integrated circuit; and/or comprising controlling a sampling frequency of the first and second light detectors by a sequencer of the integrated circuit”.
Higgins teaches controlling an operating frequency of the light source assembly by a sequencer of the integrated circuit and/or comprising controlling a sampling frequency of the first and second light detectors by a sequencer of the integrated circuit. (Paragraph [0054] multiple light sources 18 provide discrete wavelengths that may be time multiplexed by sequencer control logic 19 to individually turn on at different times. The discrete signals are transmitted through a combined optical transmit fiber 24 into the blood 26 and reflected into a receive fiber 28. The receive fiber 28 transmits the discrete reflected signals to a single photodetector of a spectrometer 22).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Lund to provide “controlling an operating frequency of the light source assembly by a sequencer of the integrated circuit; and/or comprising controlling a sampling frequency of the first and second light detectors by a sequencer of the integrated circuit” of Higgins. Doing so enables signals to be distinguished between the multiple light sources so the special effects of the signals may be measured. (Paragraph [0054]).
Claims 45-47 are rejected under 35 U.S.C. 103 as being unpatentable Waller in view of Lee (U.S. Patent Pub. No. 20160313176) (previously cited).
Regarding claim 45, Waller teaches all of the elements of the claimed invention except “in which the light detector assembly comprises a spectral sensor comprising multiple channels of operation, and the method comprising selecting a channel of operation for the spectral sensor.”
Lee, in a related field of endeavor, teaches (Figure 6) a user-wearable device comprising a light detector (110), in which the light detector assembly comprises a spectral sensor (optical sensor 122 comprising photodetector), (Paragraphs [0013], [0017]), comprising multiple channels of operation (Paragraph [0017] optical sensor 122, i.e., photodetector, can be selectively driven to emit light; Paragraph [0046] the light detector 110 can include one or more silicon photodetectors that includes four channels), and the method comprising selecting a channel of operation for the spectral sensor (Paragraphs [0046] the one or more silicon photodetectors are adapted to be responsive to red/green/blue/IR light and thereby produce a signal indicative of red/green/blue/IR light that is incident on the light detector 110).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Waller to provide “in which the light detector assembly comprises a spectral sensor comprising multiple channels of operation, and the method comprising selecting a channel of operation for the spectral sensor” of Lee. Doing so enables detection of physiological characteristics such as heart rate (HR), heart rate variability (HRV), respiratory rate (RR) and/or respiratory sinus arrhythmia (RSA), skin tone, and blood oxygen saturation (SpO2). (Paragraphs [0018]-[0020]).
Regarding claim 46, Waller teaches all of the elements of the claimed invention except “selecting a channel of operation for the spectral sensor based on a physical characteristic of the subject.”
Lee teaches selecting a channel of operation for the spectral sensor (Paragraph [0017] optical sensor 122, i.e., photodetectors, can be selectively driven to emit light; Paragraphs [0046] the one or more silicon photodetectors are adapted to be responsive to red/green/blue/IR light and thereby produce a signal indicative of red/green/blue/IR light that is incident on the light detector 110) based on a physical characteristic of the subject. (Figure 6; Paragraphs [0052]-[0054]).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Waller to provide the steps of “selecting a channel of operation for the spectral sensor based on a physical characteristic of the subject” of Lee. Doing so may help in determining an estimate of the user's present exposure to UV light. (Paragraph [0054]).
Regarding claim 47, Waller teaches all of the elements of the claimed invention except “in which the light detector assembly comprises a spectral sensor comprising multiple channels of operation, and the method comprising detecting, by the spectral sensor, an optical characteristic of ambient light.”
Lee teaches in which the light detector assembly comprises a spectral sensor (photodetector), (Paragraphs [0013], [0017]), comprising multiple channels of operation (Paragraph [0046] the light detector 110 can include one or more silicon photodetectors that includes four channels), and the method comprising detecting, by the spectral sensor, an optical characteristic of ambient light
(Paragraphs [0013], [0047]).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Waller to provide in which the light detector assembly comprises “a spectral sensor comprising multiple channels of operation, and the method comprising detecting, by the spectral sensor, an optical characteristic of ambient light” of Lee. Doing so is useful for detecting whether it is daytime or nighttime. (Paragraph [0013]).
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Hillman (U.S. Patent Pub. No. 20100168586) (previously cited) in view of Kim (KR 102116334).
Regarding claim 48, Hillman teaches a method for determining a physical characteristic of a subject (Paragraph [0090], skin cancer diagnosis), the method comprising: illuminating skin of the subject with light of multiple wavelengths from a light source assembly (different wavelengths of light from the corresponding different lasers 502, 504, 506, and 507) electrically connected to an integrated circuit (560) (Paragraphs [0106]-[0107]; detecting, by a spectral sensor of the integrated circuit, (Paragraph [0102] two-dimensional detector array, multiple linear detector arrays, or multiple linear detectors), a spectrum of light absorption by the skin (examples of some applications of the present systems and methods include spectroscopy of living tissues, such as the skin). (Paragraph [0102]); and determining, by the integrated circuit, a physical characteristic of the subject based on the detected spectrum of light absorption by the skin. (Paragraphs [0143], [0146] laminar optical tomography (LOT) can be used for imaging skin lesions; LOT can be used to measure the depth-resolved absorption properties of melanin, oxyhemoglobin, or deoxyhemoglobin).
However, Hillman does not teach “wherein determining the physical characteristic of the subject comprises determining a skin tone of the subject based on a comparison between the detected spectrum of light absorption by the skin and a reference spectrum, and selecting, by the integrated circuit, one or more channels of operation for a photoplethysmography (PPG) signal based on the determined skin tone.”
Kim, in a related field of endeavor, teaches a mask device capable of enhancing a cosmetic effect through irradiation of light having a wavelength and output power suitable for a user based on user′s skin information and skin tone, (Abstract), wherein determining the physical characteristic of the subject comprises determining a skin tone of the subject, (Page 7, lines 13-14, 20-21), based on a comparison between the detected spectrum of light absorption by the skin and a reference spectrum. (Page 8, lines 32-38, Page 9, lines 1-4, the control unit 400 analyzes the user's skin characteristics and stores the accumulated characteristic data, and compares the user's skin information with the characteristic data to calculate the user's skin condition), and selecting, by the integrated circuit, one or more channels of operation for a photoplethysmography (PPG) signal based on the determined skin tone (Page 9, lines 6-9 output control module 420 may adjust the output power of the irradiation unit 500 according to the skin tone of the user.)
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hillman as modified to teach “wherein determining the physical characteristic of the subject comprises determining a skin tone of the subject based on a comparison between the detected spectrum of light absorption by the skin and a reference spectrum, and selecting, by the integrated circuit, one or more channels of operation for a photoplethysmography (PPG) signal based on the determined skin tone” as taught by Kim. Doing so may help achieve optimal effects in beauty management and cosmetics that is personalized according to different skin tones or skin characteristics for each user. (Abstract; Page 9, lines 19-21).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Hillman in view Kim, further in view of Ermakov (U.S. Patent Pub. 20090306521) (previously cited).
Regarding claim 50, Hillman as modified teaches all of the elements of the claimed invention except “determining a physical characteristic of the subject comprises determining an amount of beta carotene in the skin of the subject.”
Ermakov, in a related field of endeavor, teaches a method for the determination of carotenoid levels in biological tissue such as living skin using reflection spectroscopy. (Abstract, Paragraph [0047]).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hillman as modified to provide “determining a physical characteristic of the subject comprises determining an amount of beta carotene in the skin of the subject” of Ermakov. Doing so may help determine the healthiness of the skin. (Paragraph [0047]).
Response to Arguments
Applicant’s arguments filed 12/17/2025 with respect to the rejection of claims 31-48 and 50 under U.S.C. 103 have been full considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made under 103 for claims 31 and 41 in view of Waller, and a new ground of rejection is made under 103 for claim 48 in view of Kim.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791