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 .
Applicant’s amendments and remarks filed on 11/19/2025 have been fully considered.
Claims 1-20 are pending for examination.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 7-12 and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions of abstract idea without significantly more. Claims 1-2, 7-12 and 17-20 recite methods, which fall within one of statutory categories (i.e. process/ machine) (Step 1: YES).
Step 2A Prong One analysis: Claims 1 and 10 recite “transforming the series of images into pseudo photoplethysmography (PPG) signals; assessing the pseudo PPG signals to identify metadata included in the pseudo PPG signals indicative of a quality of the pseudo PPG signals, determine the quality of the pseudo PPG signals based on the metadata included in the pseudo PPG signal; determining whether to provide the pseudo PPG signals to a deep learning model or to discard the pseudo PPG signals based on the determined quality of the pseudo PPG signals; and measuring or determining the disease state or the biomarker based on the pseudo PPG signals provided to the deep learning model” and “transforming the series of images into pseudo photoplethysmography (PPG) signals; assessing the pseudo PPG signals to identify metadata included in the pseudo PPG signals indicative of a quality of the pseudo PPG signal; determining a quality of the pseudo PPG signals based on the metadata included in the pseudo PPG signals; assigning a quality value to the pseudo PPG signals based on the quality of the pseudo PPG signals; providing to a deep learning model the pseudo PPG signals having the quality value exceeding a threshold value; discarding the pseudo PPG signals having the quality value less than the threshold value; and measuring or determining the disease state or biomarker based on the pseudo PPG signals provided to the deep learning model”. The claims involve calculation/ determination of parameter(s) constitutes an abstract idea of mathematical relationships/ calculations, which fall within at least one of the groupings of abstract ideas enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance (Mathematical Concepts) (Step 2A Prong One: YES).
Step 2A Prong Two analysis: Claims 1 and 10 recite “acquiring a series of images of a tissue using an optical sensor”. This judicial exception is not integrated into a practical application because the optical sensor is unaffected by how the algorithms/ calculations/ determinations operate (i.e. data collection). Thus, there is no improvement or change in the function of the optical sensor (see at least MPEP 2106.05(a), (f) and (g)). And the acquiring step associated with the optical sensor is considered as data gathering steps to be insignificant extra-solution activity using commonly known technology (e.g. Newberry, USPGPUB 2018/0214088 – cited in previous action; Sinha et al., USPGPUB 2016/0360980 – cited in previous action; Plans et al., USPGPUB 2015/0093729 – cited in previous action). “(Step 2A Prong Two: YES).
Step 2B: The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional element(s), when considered separately and in combination, are associated with data gathering steps of insignificant extra-solution activity (see MPEP 2106.05(g)) and mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (e.g. inherent property of utilizing a computer for the deep learning model/ processing, see at least paragraph [0047] of the specification of the PGPUB) (see MPEP 2106.05(f)) and do not improve the functioning of a computer, e.g. an improvement in the application of the mathematical relationship in determining the parameter(s), which is, itself, an abstract idea (see MPEP 2106.05(a)). The claims merely cover the collection of data obtained from known and existing technology and then using the data to make a correlation for parameter(s) (Step 2B: No). Dependent claims 2, 7-9, 11-12 and 17-20 do not recite additional elements/ features and do not add significantly more (i.e. an “inventive concept”) to the exception.
For these reasons, there is no inventive concept in the claims, and thus claims 1-2, 7-12 and 17-20 are ineligible.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. In regard to claim 20, “the mobile device” lacks sufficient antecedent basis.
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 1-3, 8-13 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Newberry (USPGPUB 2018/0214088 – cited above) in view of Sinha et al. (USPGPUB 2016/0360980 – cited above). In regard to claims 1 and 10, Newberry discloses a method of measuring or determining a disease state or a biomarker (abstract; Figs. 1-30 and associated descriptions), the method comprising: acquiring a series of images of a tissue using an optical sensor (steps 1702, Figs. 17-19 and associated descriptions; camera, abstract; camera, [0200-0202]; camera, [0214-0222]); transforming the series of images into pseudo photoplethysmography (PPG) signals (pixel intensity in ROI in step 1706, Fig. 17 and associated descriptions); assessing the pseudo PPG signals to identify metadata included in the pseudo PPG signals indicative of a quality of the pseudo PPG signal (average pixel intensity in ROI in step 1708, Fig. 17 and associated descriptions); determine the quality of the pseudo PPG signals based on the metadata included in the pseudo PPG signal (step 1710, Fig. 17 and associated descriptions; [0213]); determining whether to provide the pseudo PPG signals to a further processing or to discard the pseudo PPG signals based on the determined quality (Fig. 17 and associated descriptions; threshold/ ignored, [0213]; further neural network processing, Figs. 20-21 and associated descriptions); and measuring or determining the disease state or the biomarker based on the pseudo PPG signals provided to the further processing (Figs. 20-21 and associated descriptions)(claim 1) and assigning a quality value to the pseudo PPG signals based on the quality of the pseudo PPG signals (Fig. 17 and associated descriptions; weight, [0213]); providing to a further processing of the pseudo PPG signals having the quality value exceeding a threshold value (Fig. 17 and associated descriptions; threshold/ data not being ignored/ height weight, [0213]; further neural network processing, Figs. 20-21 and associated descriptions); discarding the pseudo PPG signals having the quality value less than the threshold value (Fig. 17 and associated descriptions; threshold/ ignored, [0213]) (additional features for claim 10).
Newberry does not specifically disclose the further processing/ neural network processing is a deep learning model.
Sinha teaches a method of acquiring PPG data using an optical sensor/ a camera of a mobile device (abstract; Figs. 1-8 and associated descriptions) and machine learning approaches such as neural networks or deep learning algorithm can be utilized in any suitable step of the method 200 (Figs. 2-4 and associated descriptions; [0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the further PPG processing/ neural network processing (Newberry) with the deep learning algorithm and associated steps/functions as taught by Sinha, since both devices are camera based PPG systems and one of ordinary skill would have recognized that neural network and deep learning algorithm are alternative equivalent machine learning methods for processing PPG signals. The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
In regard to claims 2 and 12, Newberry as modified by Sinha discloses the series of images comprises a video signal (Fig, 17 and associated descriptions; video, [0211-0215] of Newberry).
In regard to claims 3 and 13, Newberry as modified by Sinha discloses controlling a flash and exposure settings of the camera (exposure, [0206]; flash, [0209] of Newberry).
In regard to claims 8 and 18-19, Newberry as modified by Sinha discloses the biomarker comprises measures of blood pressure, heart rate, SpO2, or other health-related quantity (abstract; [0024]; [0061]; [0138]; [0158] of Newberry).
In regard to claims 9 and 20, Newberry as modified by Sinha discloses the optical sensor is included in a mobile device that is a smartphone, wrist-worn wearable such as smartwatch or smart wristband, earbud, or tablet ([0221]; [0263] of Newberry).
In regard to claim 11, Newberry as modified by Sinha discloses transforming the series of images into the pseudo PPG signals (referring to claims 1 and 10 above) but does not specifically disclose applying a second deep learning model to the series of images, wherein an output of the second deep learning model is the pseudo PPG signals. However, Sinha further teaches that machine learning approaches such as deep learning algorithm can be utilized in any suitable step of the method 200, including generating PPG signals/ data from time series of images data (Figs. 2-4 and associated descriptions; [0029]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the method of generating PPG data from images with the deep learning algorithm as taught by Sinha to yield predictable results. The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Newberry and Sinha as applied to claims 1-3, 8-13 and 18-20 above, and further in view of Plans et al. (USPGPUB 2015/0093729 – cited in previous action). In regard to claims 4 and 14, Newberry as modified by Sinha discloses discarding the pseudo PPG signals comprises: not providing the pseudo PPG signals to the deep learning model (ignored, [0213] of Newberry; referring to claims 1 and 10 above) but does not specifically disclose adjusting the flash or the exposure settings of the camera; and initiating additional acquiring of images of the tissue using the adjusted flash or exposure settings.
Plans teaches a camera based PPG devices (Figs. 1-5 and associated descriptions) comprises a camera on a smartphone/cellphone ([0022]; [0037]) for acquiring PPG data from the user ([0112]; [0118]) and adjusting the flash or the exposure settings of the camera; and initiating additional acquiring of images of the tissue using the adjusted flash or exposure settings (different settings/ configurations [0064]).
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 methods (Newberry as modified by Sinha) to incorporate changing the flash and exposure settings/ configurations of the camera and initiating capturing additional image data using the changed settings/ configurations as taught by Plans, since both devices are camera based PPG systems and one of ordinary skill would have recognized that changing the flash and exposure settings/ configurations of the camera and initiating capturing additional image data facilitate obtaining best/ higher quality of images (see Plans). The rationale would have been to obtain best/ higher quality of images for PPG measurements.
Claims 5-6 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Newberry and Sinha as applied to claims 1-3, 8-13 and 18-20 above, and further in view of Ahmed et al. (USPGPUB 2018/0028123 – cited in previous action). In regard to claims 5-6 and 15-16, Newberry as modified by Sinha discloses measuring ambient light reaching the tissue using a photosensor onboard the mobile device (camera/ ambient light, [0209] and [0219] of Newberry) but does not specifically disclose measuring relative motion between the tissue and the camera using an accelerometer onboard the mobile device; and grouping the measured ambient light and the measured relative motion as metadata and the quality of the pseudo PPG signals is based, at least in part, on the metadata.
Ahmed teaches measuring ambient light reaching the tissue using a photosensor onboard the mobile device and measuring relative motion between the tissue and the camera using an accelerometer onboard the mobile device (a wide variety of sensors can be incorporated into mobile devices such as an accelerometer and an ambient light sensor…, [0002], and the mobile device can be a mobile phone, [0030]) and the quality of the PPG signals is related to the combination of movement and ambient light information (the quality of the data provided by the photoplethysmograph may depend on how securely the sensor is engaged with the user, otherwise movement of the sensor with respect to the user may produce erroneous signal components, such as may be attributed to varying amounts of ambient light being recorded, [0002]).
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 methods (Newberry as modified by Sinha) to incorporate the ambient light sensor and the accelerometer into the mobile device and utilize the combination of motion data and ambient light data for PPG quality analysis as taught by Ahmed, since both devices are PPG sensing systems and one of ordinary skill in the art would have recognized that the PPG quality is associated with both motion and ambient light data (see Ahmed). The rationale would have been to obtain additional quality analysis of the obtained PPG data.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Newberry and Sinha as applied to claims 1-3, 8-13 and 18-20 above, and further in view of Al-Ali et al. (USPN 6,334,065 – cited in previous action). In regard to claims 7 and 17, Newberry as modified by Sinha discloses all the claimed limitations except analyzing shapes and features of waveforms of the pseudo PPG signals, wherein the quality of the pseudo PPG signals is additionally based on the shapes and features of the waveforms.
Al-Ali teaches a PPG device (Figs. 1-2. 6 and 14 and associated descriptions) comprises analyzing shapes and features of waveforms of PPG signals, wherein the quality of the PPG signals is based on the shapes and features of the waveforms (elements 630/632/634/1420/1430/1440/1450, Figs. 6 and 14 and associated descriptions; provides an indication of plethysmograph quality and acts as a threshold for determining whether to ignore portions of the input signal, Col 9 line 66 – Col 10 line 34; provides an indication of waveform quality, Col 15 lines 6-48).
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 methods (Newberry as modified by Sinha) to incorporate analyzing shapes and features of waveforms of PPG signals for PPG quality analysis as taught by Al-Ali, since both devices are PPG sensing systems and one of ordinary skill in the art would have recognized that the shapes and features of waveforms of PPG signals can be analyzed for providing PPG quality information (see Al-Ali). The rationale would have been to obtain more PPG quality information from the PPG signals.
Response to Arguments
Applicant's arguments filed on 11/19/2025 have been fully considered but they are not persuasive. In regard to the 35 USC 101 rejections, applicant alleged that the claims specify practical and technological improvements implemented through structured and technical processes, the claims do not merely recite steps that can performed in the human mind and the claims integrate the abstract concept into a specific, practical system. In response, first of all, “if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine that the claim improves technology”, see MPEP 2106.04(d)(1). Secondly, the claims are not rejected based on mental process, e.g. performed in the human mind). Third, the claims do not integrate abstract concept into a specific, practical system since the claims merely recite an optical sensor included in a device for collecting data without any additional or specific element(s)/ structure(s)/ configuration(s). Therefore, the 35 USC 101 rejections are maintained for the reasons of record.
In regard to the art rejections, applicant alleged that the combination of Newberry and Sinha does not teach the amended features. In response, the combination of Newberry and Sinha discloses the amended features (see above).
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 CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791