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 .
Election/Restrictions
Claim 4 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/28/2026.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 and/or 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
There are forty parent applications listed. However, the subject matter of claims 1, 12, and 20 appears for the first time in Application no. 16/516,654, filed 08/26/2019. Therefore, independent claims 1, 12, and 20 are entitled to the priority date of Aug. 26, 2019.
With respect to the dependent claims, it appears that the subject matter of all dependent claims is first presented in the instant Application having the filing date of 01/18/2025. Therefore, claims 2-11 and 13-19 are entitled to the priority date of Jan. 18, 2025.
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.
Claim(s) 1, 3, 5, 7-8, 12, and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Melker et al. (US 2016/0022157 A1, Jan. 28, 2016) (hereinafter “Melker”).
Regarding claim 1: Melker discloses a system, comprising: a frame configured to be worn on a user's head (fig. 3B, PPG sensor 300 having a sensor body that is the support - [0024], [0026]-[0030], where the nose is part of the head); a first photoplethysmography (PPG) device physically coupled to the frame so that it is in contact with a first side of the user's nose, the first PPG device includes a first light source and a first photodetector ([0024], fig. 3B, emitter 320 and detector 350); a second PPG device physically coupled to the frame so that it is in contact with a second side of the user's nose, the second PPG device includes a second light source and a second photodetector ([0024], fig. 3B, emitter 330 and detector 360); and a computer ([0041], [0060]) configured to: obtain, from each of the first and second PPG devices, first and second signals indicative of blood flow in nasal tissue on the first and second sides of the user's nose, respectively ([0024], [0041], [0064]); and calculate, from the first and second signals, a measurement of the user's blood flow ([0041], [0044]-[0045]).
Regarding claim 3: Melker discloses the system of claim 1, wherein the computer is further configured to operate the first and second light sources in non-overlapping time intervals, such that the first light source is activated when the second light source is off, and vice versa, thereby mitigating interference between the first and the second PPG devices ([0046]-[0047]).
Regarding claim 5: Melker discloses the system of claim 1, wherein the computer is further configured to operate the first photodetector, for at least some of its operating time, out of phase with the first light source, such that the first photodetector measures a pass-through signal ([0047] - While Melker does not use the term "pass-through" this is a description of the same operating configuration); whereby the pass-through signal is at least partially attributable to light emitted by the second light source and detected by the first photodetector when the second light source is operating, and wherein the computer further utilizes the pass-through signal to calculate the measurement of the user's blood flow ([0047] - While Melker does not use the term "pass-through" this is a description of the same operating configuration).
Regarding claim 7: Melker discloses the system of claim 1, wherein the computer is further configured to calculate, based on the first and second signals, first and second measurements indicative of blood flow in the first and second sides of the user's nose ([0041], [0044]-[0045] - first and second signal streams).
Regarding claim 8: Melker discloses the system of claim 7, wherein the computer is further configured to calculate a blood pressure value of the user based on a phase difference between the first and second measurements, whereby the phase difference is indicative of timing offsets in blood flow characteristics between the first and second sides of the user's nose ([0044]-[0045], [0054]-[0055]).
Regarding claim 12: Melker discloses a method for measuring blood flow in a user's nasal tissue, comprising: measuring, utilizing a first photoplethysmography (PPG) device, a first signal indicative of blood flow in nasal tissue on a first side of the user's nose ([0024], [0041], [0064]); wherein the first PPG device comprises a first light source and a first photodetector, coupled to a frame configured to be worn on a user's head and contacting the first side of the user's nose (fig. 3B, PPG sensor 300 having a sensor body that is the support - [0024], [0026]-[0030], where the nose is part of the head; [0024], fig. 3B, emitter 320 and detector 350); measuring, utilizing a second PPG device coupled to the frame and contacting a second side of the user's nose, a second signal indicative of blood flow in nasal tissue on the second side ([0024], [0041], [0064]); wherein the second PPG device comprises a second light source and a second photodetector ([0024], fig. 3B, emitter 330 and detector 360); and calculating, utilizing a computer, a measurement of the user's blood flow based on the first signal and the second signal ([0041], [0044]-[0045]).
Regarding claim 14: Melker discloses the method of claim 12, further comprising operating the first and second light sources in non-overlapping time intervals, such that the first light source is activated only when the second light source is off, and vice versa, to mitigate interference between the first and second PPG devices ([0046]-[0047]).
Regarding claim 15: Melker discloses the method of claim 12, further comprising operating the first photodetector, for at least some of its operating time, out of phase with the first light source, such that the first photodetector measures a pass-through signal ([0047] - While Melker does not use the term "pass-through" this is a description of the same operating configuration); whereby the pass-through signal is at least partially attributable to light emitted by the second light source and detected by the first photodetector when the second light source is operating; and utilizing the pass-through signal to calculate the measurement of the user's blood flow ([0047] - While Melker does not use the term "pass-through" this is a description of the same operating configuration).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2, 10, 13, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melker in view of Matsumura et al. (US 2022/0386881 A1, Dec. 8, 2022) (hereinafter “Matsumura”).
Regarding claims 2 and 13: Melker discloses the system of claim 1 and the method of claim 12. Melker further discloses wherein the computer is further configured to: determine a timing offset based on differences in detected arrival times of pulse waves at the first and second PPG devices ([0018], [0045], [0047], [0053]-[0056], [0060]), but is silent on utilizing the determined timing offset to adjust the operation times of the first and second light sources, such that the light sources are activated in accordance with the expected arrival times of pulse waves at each side of the user's nose.
Matsumura, in the same field of endeavor, discloses determining a timing offset based on differences in detected arrival times of pulse waves at the first and second PPG devices ([0061], [0070]-[0071]); and utilizing the determined timing offset to adjust the operation times of the first and second light sources, such that the light sources are activated in accordance with the expected arrival times of pulse waves at each side of the user's nose ([0072]). Matsumura further discloses that PPG sensors use LED illumination which consumes a large amount of power and that it is desirable to reduce power consumption in order to increase battery life without increasing the size of the device ([0005]-[0006]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system and method of Melker by performing the gated activation of the light sources as taught by Matsumura in order to extend battery life and reduce power consumption.
Regarding claims 10 and 18: Melker discloses the system of claim 1 and the method of claim 12. Melker further discloses detecting the arrival of a pulse wave at the first side of the user's nose using the first PPG device ([0044]-[0045]); determining a phase shift between the pulse wave arrival at the first side of the user's nose and the pulse wave arrival at the second side of the user's nose ([0044]-[0045], [0047]); and determining a pulse transit time value from the phase difference ([0018] - PTT is determined from phase difference). Melker is silent on determining when to activate the second light source; or adjusting the sampling frequency of the second photodetector to coincide with the expected arrival of the pulse wave.
Matsumura, in the same field of endeavor, discloses using a pulse transit time (PTT) value to control operating characteristics of the second PPG device, including at least one of: determining when to activate the second light source ([0072]); or adjusting the sampling frequency of the second photodetector to coincide with the expected arrival of the pulse wave ([0072]). Matsumura further discloses that PPG sensors use LED illumination which consumes a large amount of power and that it is desirable to reduce power consumption in order to increase battery life without increasing the size of the device ([0005]-[0006]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system and method of Melker by performing the gated activation of the light sources as taught by Matsumura in order to extend battery life and reduce power consumption.
Claim(s) 6, 9, 16, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melker in view of Lisogurski (US 2016/0278674 A1, Sep. 29, 2016) (hereinafter “Lisogurski”).
Regarding claims 6 and 16: Melker discloses the system of claim 1 and the method of claim 12, but is silent on extracting from the measurement of the user's blood flow at least one of the following parameters: systolic peak, dicrotic notch, diastolic peak, interbeat interval, and systolic-diastolic peak-to-peak time.
Lisogurski, in the same field of endeavor, discloses determining a measure of a user’s blood flow from a PPG sensor ([0017]) and extracting from the measurement of the user's blood flow at least one of the following parameters: systolic peak, dicrotic notch, diastolic peak, interbeat interval, and systolic-diastolic peak-to-peak time in order to determine if the sensor is on the user and that the measurements are valid ([0024], [0034]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system and method of Melker to include extracting from the measurement of the user's blood flow at least one of the following parameters: systolic peak, dicrotic notch, diastolic peak, interbeat interval, and systolic-diastolic peak-to-peak time as taught by Lisogurski in order to determine if the sensor is on the user and that the measurements are valid.
Regarding claims 9 and 17: Melker discloses the system of claim 1 and the method of claim 12, further comprising obtaining a plurality of signals from the first and second PPG devices, and calculating the measurement of the user's blood flow ([0024], [0041], [0044]-[0045], [0064]) but is silent on identifying common pulse wave characteristics across the signals, including the systolic pulse, to consolidate the signals into a single enhanced measurement; compensating for slight phase shifts between the signals caused by physiological or timing differences; and applying signal aggregation techniques, including at least one of: averaging corresponding features of the pulse wave across the signals, weighting the signals based on their respective signal-to-noise ratios, or aligning the signals using a cross-correlation algorithm to maximize consistency in the pulse wave shape.
Lisogurski, in the same field of endeavor, discloses obtaining signals from a two or more PPG sensors ([0021]-[0022]), and calculating the measurement of the user's blood flow by: identifying common pulse wave characteristics across the signals, including the systolic pulse, to consolidate the signals into a single enhanced measurement ([0019], [0032]-[0033]); compensating for slight phase shifts between the signals caused by physiological or timing differences ([0032]-[0033]); and applying signal aggregation techniques, including at least one of: averaging corresponding features of the pulse wave across the signals, weighting the signals based on their respective signal-to-noise ratios, or aligning the signals using a cross-correlation algorithm to maximize consistency in the pulse wave shape ([0032]-[0034]). Lisogurski further discloses that such a procedure is ensemble averaging, which is performed in order to improve the signal-to-noise ratio ([0018]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system and method of Melker by including the ensemble averaging of Lisogurski in order to improve the signal-to-noise ratio of the acquired signals.
Claim(s) 11 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melker in view of Huang (US 2020/0315475 A1, Oct. 8, 2020) (hereinafter “Huang”).
Regarding claims 11 and 19: Melker discloses the system of claim 1 and the method of claim 12, including wherein each of the first and second PPG devices includes at least two light sources configured to emit light at different wavelengths, including at least one of green, red, or infrared wavelengths ([0020], [0025] - multiple wavelengths including red and infrared), but is silent on determining signal-to-noise (S/N) characteristics of the signals obtained from the first and second PPG devices; and selecting, based on the determined S/N characteristics, the wavelength to be emitted by each PPG device to optimize the quality of the signals obtained from the respective sides of the user's nose.
Huang, in the same field of endeavor, discloses a PPG measurement system and method comprising multiple illumination wavelengths including at least one of green, red, or infrared wavelengths ([0047], claims 21 and 31), and further comprising: determining signal-to-noise (S/N) characteristics of the signals obtained from the first and second PPG devices (fig. 5; claims 25, 27, 34, and 36); and selecting, based on the determined S/N characteristics, the wavelength to be emitted by each PPG device to optimize the quality of the signals (fig. 5; claims 26, 28, 35, and 37).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system and method of Melker to include the multiple illumination wavelength selection based on SNR of the first and second PPG devices as taught by Huang in order to improve and optimize the collected signals.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melker et al. (US 2016/0022157 A1, Jan. 28, 2016) (hereinafter “Melker”) in view of Shemesh et al. (US 2017/0020399 A1, Jan. 26, 2017) (hereinafter “Shemesh”).
Regarding claim 20: Melker discloses a head-mounted photoplethysmography system, comprising: a first head-mounted (the face/nose is part of the head) photoplethysmography (PPG) device in physical contact with a first side of a user's nose ([0024], fig. 3B, emitter 320 and detector 350); a second head-mounted PPG device in physical contact with a second side of the user's nose ([0024], fig. 3B, emitter 330 and detector 360); and computer ([0041], [0060]) configured to: operate the first and second light sources in non-overlapping time intervals, such that the first light source is activated when the second light source is off, and vice versa, thereby mitigating interference between the first and second PPG devices ([0046]-[0047]); obtain, from each of the first and second PPG devices, first and second signals indicative of blood flow in nasal tissue on the first and second sides of the user's nose, respectively ([0024], [0041], [0064]); and calculate, from the first and second signals, a measurement of the user's blood flow ([0041], [0044]-[0045]).
Melker is silent on the location of the computer as being head-mounted.
Shemesh in the same field of endeavor, discloses a head-mounted PPG system with two PPG sensors in physical contact with each side of a user’s nose (fig. 8D) having a head-mounted computer for processing the acquired signals ([0073], [0097]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the computer of Melker as head-mounted in order to enable a compact, self-contained device without need of external processing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799
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