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 11/14/2025 have been fully considered.
Claims 1-3 and 5-20 are pending for examination. Claim 4 is cancelled.
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 1-3 and 5-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions of abstract idea without significantly more. Claims 1-3 and 5-20 recite a system, a method and a non-transitory machine-executable media, which fall within one of statutory categories (i.e. process/ machine) (Step 1: YES).
Step 2A Prong One analysis: Claims 1 and 19-20 recite “create a first red plethysmograph waveform from a red image; create a second infrared (IR) plethysmograph waveform from an infrared (IR) image; process the first red plethysmograph waveform using wavelet decomposition to obtain a first pulse plethysmograph waveform; process the second IR plethysmograph waveform using wavelet decomposition to obtain a second pulse plethysmograph waveform; calculate an oxygen absorption value using the first pulse plethysmograph waveform and the second pulse plethysmograph waveform; and determine the oxygen saturation value for the patient using a reference calibration curve and the oxygen absorption value”. The claims involve calculation/ determination of parameter(s) constitutes an abstract idea of mathematical relationships/ calculations or mental process), 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: Claim 1 and 20 recite “a processor”, Claims 3 and 20 recites ”a second device”, and claim 5 recites “a remote device”. This judicial exception is not integrated into a practical application because the second device and a remote device is unaffected by how the algorithms/ calculations/ determinations operate. Thus, there is no improvement or change in the function of the system (see at least MPEP 2106.05(a), (f) and (g)). And the generate alert steps/ functions (claims 1 and 19-20) are considered as insignificant extra-solution activity. And/ or the abstract idea (mental process) is directed as being performed 1) on a generic computer, or 2) in a computer environment, or 3) is merely using a computer as a tool to perform the concept (see MPEP 2106.04(a)(2).III.C) “(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 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 (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 data conversion/ calculation/ processing and then using the result to make a correlation for parameter(s) (Step 2B: No). Dependent claims 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 1-3 and 5-20 are ineligible.
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, 5-8, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Verkruijsse et al. (USPGPUB 2017/0014087 – cited in previous action) in view of Li et al. (USPN 7,725,146 – cited in previous action) and further in view of Addison et al. (USPGPUB 20170238805 – applicant cited). In regard to claim 1, Verkruijsse discloses a system for detecting an oxygen saturation level of a patient (Figs. 1-3 and associated descriptions) comprising: a processor (elements 32/34, Figs. 1-2 and associated descriptions; [0045]) to: create a first red plethysmograph waveform from a red image (PPG signals from images, [0045]; 660nm or 750nm, [0046-0047]); create a second infrared (IR) plethysmograph waveform from an infrared (IR) image (PPG signals from images, [0045]; 800nm, [0046]); calculate an oxygen absorption value using the first red plethysmograph waveform and the second infrared (IR) plethysmograph waveform (AC/DCIR / AC/DCR , Figs. 3A and 3C and associated descriptions; ratio of ratios, [0047]); and determine the oxygen saturation value for the patient using a reference calibration curve and the oxygen absorption value (calibration curves for R1-R4, Fig. 3C and associated descriptions; AC/DCIR / AC/DCR , Figs. 3A and 3C and associated descriptions; ratio of ratios, [0047]; SpO2, [0049]).
Verkruijsse discloses all the claimed limitations except process the first red plethysmograph waveform using wavelet decomposition to obtain a first pulse plethysmograph waveform; process the second IR plethysmograph waveform using wavelet decomposition to obtain a second pulse plethysmograph waveform; and perform further calculation using the first pulse plethysmograph waveform and the second pulse plethysmograph waveform.
Li teaches a pulse oximetry system (Figs. 1-2 and associated descriptions) comprises the use of red and infrared lights for oxygen saturation determination (Col 3 line 54 – Col 4 line 33) and oximetry signals (block 40, Fig. 2 and associated descriptions; plethysmographic waveform, Col 4 lines 34-48) is/are processed using wavelet decomposition (blocks 46/48/50/56/58/60 and 62, Fig. 2 and associated descriptions; discrete wavelet transformation, Col 4 line 59 – Col 6 line 45) and perform inverse wavelet transform to output clean waveform for being processed to determine one or more physiological characteristics of interest (blocks 62-64, Fig. 2 and associated descriptions; clean waveform, Col 6 lines 37-45; a clean version of the physiological signal from which some or all of the noise and/or artifacts have been removed, abstract).
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 (Verkruijsse) to incorporate the wavelet decomposition and associated elements/ functions as taught by Li to both the red and infrared plethysmograph waveforms, since both systems are pulse oximetry devices and one of ordinary in the art would have recognized that wavelet decomposition facilitate preprocessing oximetry signals/ waveforms before being utilized for oxygen saturation calculations (see Li). The rationale would have been to obtain more accurate physiological parameters/ oxygen saturation measurements.
Verkruijsse as modified by Li does not specifically disclose generate an alert in response to detecting the oxygen saturation value is below or above a predetermined range, wherein the alert indicates the patient is experiencing a medical event.
Addison teaches a similar contactless image/ video oximetry system (Figs. 2-17 and associated descriptions) comprises generate an alert in response to detecting the oxygen saturation value is below or above a predetermined range, wherein the alert indicates the patient is experiencing a medical event (Fig. 7 and associated descriptions; trigger an alarm when the trend shows that SpO2 is rapidly changing or has crossed an alarm threshold. Clinically relevant patterns (such as repeated desaturations) may also be detected, [0023] and [0125]; trigger alarms based on physiologic limits (for example, high or low heart rate/SpO2 alarms… triggered alarms can be used by clinicians to identify patients in distress, [0117]; identifies acute hypoxia in monitored patients, by identifying episodes of decreased oxygen saturation, [0129]; It is noted that applicant alleged the medical event includes “a seizure, pain, stress, or other conditions based on facial features, body position” in the original Specification Paragraph [0065], see the Remarks filed in 11/14/2025. However, it is improper to import limitations from the specification into the claims (see MPEP 2111.01)).
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 (Verkruijsse as modified by Li) to incorporate the alert generation associated functions/elements/steps as taught by Addison, since one of ordinary skill in the art would have recognized that generating alert when the measured vital signs/ SpO2 crosses an alarm threshold facilitate informing the caregiver that clinical condition(s) of the patient/ user is changing (see Addison). The rationale would have been to better inform the caregiver regarding the change of clinical condition(s) of the patient.
In regard to claim 3, Verkruijsse as modified by Li and Addison discloses the reference calibration curve calibrates the system to a second device with an accuracy above a predetermined threshold (“The contrast for changes in SpO2 (and thus accuracy/sensitivity) is highest when the red wavelength is chosen close to 660 nm”, [0046]; R2 has higher SpO2 contrast as compared to any other devices utilizes R1, R3 and/or R4, Figs. 3A and 3C and associated descriptions of Verkruijsse).
In regard to claim 5, Verkruijsse as modified by Li and Addison discloses the processor is further configured to transmit the alert to a remote device (remote display 222, Fig. 2A and associated descriptions; [0078]; [0122]; [0124] of Addison).
In regard to claim 6, Verkruijsse as modified by Li and Addison discloses the calculating the oxygen absorption value comprises: calculating a first amplitude of pulsations in the first pulse plethysmograph waveform (AC of R, Figs. 3A and 3C and associated descriptions; ratio of ratios, [0047]; SpO2, [0049] of Verkruijsse) and a second amplitude of pulsations in the second pulse plethysmograph waveform (AC of IR, Figs. 3A and 3C and associated descriptions; ratio of ratios, [0047]; SpO2, [0049] of Verkruijsse); calculating a first baseline offset in pulsations in the first pulse plethysmograph waveform (DCR , Figs. 3A and 3C and associated descriptions; ratio of ratios, [0047]; SpO2, [0049] of Verkruijsse) and a second baseline offset in pulsations in the second pulse plethysmograph waveform (DCIR , Figs. 3A and 3C and associated descriptions; ratio of ratios, [0047]; SpO2, [0049] of Verkruijsse); and combining the first amplitude, the second amplitude, the first baseline offset, and the second baseline offset to determine the oxygen absorption value (AC/DCIR / AC/DCR , Figs. 3A and 3C and associated descriptions; ratio of ratios, [0047]; SpO2, [0049] of Verkruijsse).
In regard to claim 7, Verkruijsse as modified by Li and Addison discloses the wavelet decomposition used to obtain the first pulse plethysmograph waveform and the second pulse plethysmograph waveform comprises removing a motion artifact from the red image or the IR image (artifacts and/or noise have been removed or reduced, abstract and Col 3 lines 1-11; patient motion and artifacts removal, Col 3 Col 4 line 9 – Col 6 line 45 of Li).
In regard to claim 8, Verkruijsse as modified by Li and Addison discloses the red image and the IR image comprise imaging data obtained from one or more regions of skin of the patient (Fig. 1 and associated descriptions; [0042] of Verkruijsse).
In regard to claim 19, Verkruijsse as modified by Li and Addison discloses a method for detecting an oxygen saturation level of a patient (referring to claim 1 above) comprising: creating a first red plethysmograph waveform from a red image (referring to claim 1 above); creating a second infrared (IR) plethysmograph waveform from an infrared (IR) image (referring to claim 1 above); processing the first red plethysmograph waveform using wavelet decomposition to obtain a first pulse plethysmograph waveform (referring to claim 1 above); processing the second IR plethysmograph waveform using wavelet decomposition to obtain a second pulse plethysmograph waveform (referring to claim 1 above); calculating an oxygen absorption value using the first pulse plethysmograph waveform and the second pulse plethysmograph waveform (referring to claim 1 above); determining an oxygen saturation value for the patient using a reference calibration curve and the oxygen absorption value (referring to claim 1 above); and generating an alert in response to detecting the oxygen saturation value is below or above a predetermined range, wherein the alert indicates the patient is experiencing a medical event (referring to claim 1 above).
In regard to claim 20, Verkruijsse as modified by Li and Addison discloses a non-transitory machine-executable media, the non-transitory machine-executable media comprising a plurality of instructions that, in response to execution by a processor, cause the processor to: create a first red plethysmograph waveform from a red image (referring to claim 1 above); create a second infrared (IR) plethysmograph waveform from an infrared (IR) image (referring to claim 1 above); process the first red plethysmograph waveform using wavelet decomposition to obtain a first pulse plethysmograph waveform (referring to claim 1 above); process the second IR plethysmograph waveform using wavelet decomposition to obtain a second pulse plethysmograph waveform (referring to claim 1 above); calculate an oxygen absorption value using the first pulse plethysmograph waveform and the second pulse plethysmograph waveform (referring to claim 1 above); determine an oxygen saturation value for the patient using a reference calibration curve and the oxygen absorption value (referring to claim 1 above), wherein the reference calibration curve calibrates the system to a second device with an accuracy above a predetermined threshold (referring to claims 1 and 3 above); and generate an alert in response to detecting the oxygen saturation value is below or above a predetermined range, wherein the alert indicates the patient is experiencing a medical event (referring to claim 1 above).
Claims 2, 9-12 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Verkruijsse and Li and Addison as applied to claims 1, 3, 5-8, and 19-20 above, and further in view of Kaestle (USPGPUB 2017/0319114 – cited in previous action). In regard to claim 2, Verkruijsse as modified by Li and Addison discloses the patient can be a neonate or premature infant, e.g. lying in an incubator ([0041]) but does not specifically disclose the red image is obtained from a red-green-blue (RGB) image of the patient in an infant care station.
Kaestle teaches a contactless oximetry system (Figs. 1-10 and associated descriptions) comprises a RGB image sensor providing red and infrared images of the newborn baby ([0028]; Fig. 1 and associated descriptions).
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 red image and/or camera (Verkruijsse as modified by Li and Addison) with the red image and/or camera as taught by Kaestle to yield predictable results, since one of ordinary skill in the art would have recognized that the RGB image sensor utilized for newborn baby monitoring is an alternative equivalent sensor for generating red images. 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 9-12 and 14, Verkruijsse as modified by Li, Addison and Kaestle discloses the one or more regions of skin includes a forehead ([0042] of Verkruijsse) but does not specifically disclose the one or more regions of skin of the patient comprise at least a peripheral limb and a forehead; the one or more regions of skin of the patient comprise at least a peripheral limb and an abdomen; the one or more regions comprise at least an abdomen and a forehead of the patient; determine the oxygen saturation value from the abdomen of the patient and determine a second oxygen saturation value from the forehead of the patient; compare the oxygen saturation value and the second oxygen saturation value; and determine a relative difference between the oxygen saturation value from the abdomen and the second oxygen saturation value from the forehead, wherein the relative difference indicates a disease state; and obtain the first red plethysmograph waveform from the red image and the second IR plethysmograph waveform from the IR image, wherein the red image and the IR image are captured from one or more regions of the patient; calculate separate oxygen saturation values for each of the one or more regions using the first red plethysmograph waveform and the second IR plethysmograph waveform; and generate a relative value representing a difference between the oxygen saturation values for each of the one or more regions.
Kaestle further teaches to image one or more regions of skin of the patient (Figs. 1-6 and associated descriptions) comprise at least a peripheral limb and a forehead ([0025]; [0073]; [0112]); the one or more regions of skin of the patient comprise at least a peripheral limb and an abdomen ([0073] and [0076]); the one or more regions comprise at least an abdomen ([0073] and [0076]) and a forehead ([0025]; [0112]) of the patient; determine the oxygen saturation value from the abdomen of the patient and determine a second oxygen saturation value from the forehead of the patient; compare the oxygen saturation value and the second oxygen saturation value; and determine a relative difference between the oxygen saturation value from the abdomen and the second oxygen saturation value from the forehead, wherein the relative difference indicates a disease state (CCHD, [0011-0026]; difference of oxygen saturations, [0032-0034]; [0080-0081]; ROI or CCHD, [0073]; Figs. 7-8 and associated descriptions) and obtain the first red plethysmograph waveform from the red image and the second IR plethysmograph waveform from the IR image, wherein the red image and the IR image are captured from one or more regions of the patient; calculate separate oxygen saturation values for each of the one or more regions using the first red plethysmograph waveform and the second IR plethysmograph waveform; and generate a relative value representing a difference between the oxygen saturation values for each of the one or more regions (CCHD, [0011-0026]; difference of oxygen saturations, [0032-0034]; [0080-0081]; ROI or CCHD, [0073]; Figs. 7-8 and associated descriptions).
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 to incorporate the one or more ROIs and associated differences of the vital signs/ oxygen saturations between the ROIs of the newborn baby in order to obtain more health/ congenital heart disease related status(es).
In regard to claims 15 and 16, Verkruijsse as modified by Li, Addison and Kaestle discloses the processor is further configured to: obtain the first red plethysmograph waveform from the red image and the second IR plethysmograph waveform from the IR image, wherein the red image and the IR image are captured from one or more regions of the patient (referring to claims 1, 8-12 and 14 above) but does not specifically disclose calculate separate heart rate values for each of the one or more regions using the first plethysmograph waveform and the second plethysmograph waveform; generate a relative value representing a difference between the heart rate values for each of the one or more regions; and calculate separate respiration rate values for each of the one or more regions using the first plethysmograph waveform and the second plethysmograph waveform; and generate a relative value representing a difference between the respiration rate values for each of the one or more regions. Verkruijsse as modified by Li , Addison and Kaestle discloses compare vital sign(s) obtained from different ROIs (see above) and it is commonly known in the art that PPG can be utilized to calculate heart/ pulse rate and respiration (see at least [0004] of Verkruijsse; Fig. 6A and associated descriptions of Addison). Therefore, 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 to calculate heart values/ respiration rates from detected PPG waveforms and determine differences between the vital signs from different ROIs in order to obtain more physiological/ health related status of the newborn baby.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Verkruijsse and Li and Addison as applied to claims 11, 3, 5-8, and 19-20 above, and further in view of Lovejoy et al. (USPGPUB 2012/0197142 – cited in previous action). In regard to claim 13, Verkruijsse as modified by Li and Addison discloses all the claimed limitations except the processor is further configured to: obtain a transit plethysmography signal from a central location of the patient and a peripheral location of the patient; and determine a differential measurement representing a pulse transit time using the transit plethysmography signal from the central location and the peripheral location.
Lovejoy teaches an oximetry system (Figs. 1-10) comprises obtain a transit plethysmography signal from a central location of the patient and a peripheral location of the patient; and determine a differential measurement representing a pulse transit time using the transit plethysmography signal from the central location and the peripheral location (PPG, difference in signals…physiological responses in different vasculatures, for example, the response in a central vasculature versus a peripheral vasculature, [0026]; central/ peripheral pulse transit time, [0052]).
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 (Verkruijsse as modified by Li and Addison) to incorporate the pulse transit time calculation based on central and peripheral regions as taught by Lovejoy, since both systems are pulse oximetry devices and one of ordinary skill in the art would have recognized that pulse transit time provide additional perfusion/ cardiovascular/physiological information (see Lovejoy). The rationale would have been to obtain additional perfusion/ cardiovascular/physiological information of the patient.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Verkruijsse and Li and Addison as applied to claims 11, 3, 5-8, and 19-20 above, and further in view of Shah et al. (USPGPUB 2019/0159739 - cited in previous action). In regard to claims 17 and 18, Verkruijsse as modified by Li and Addison discloses all the claimed limitations except the processor is further configured to process said first pulse plethysmograph waveform to obtain a peak to peak interval indicating a first heart rate (HR) value and process said second pulse plethysmograph waveform to obtain a peak to peak interval indicating a second heart rate (HR) value and to combine the first HR value and the second HR value to form an average heart rate value.
Shah teaches an oximetry system (Figs. 1-10 and associated descriptions) comprises to process said first pulse plethysmograph waveform to obtain a peak to peak interval indicating a first heart rate (HR) value (red and peak-to-peak distance/ pulse rate, [0065-0068]; Fig. 10 and associated descriptions) and process said second pulse plethysmograph waveform to obtain a peak to peak interval indicating a second heart rate (HR) value (infrared and peak-to-peak distance/ pulse rate, [0065-0068]; Fig. 10 and associated descriptions) and averaging pulse rate data over a period of time may yield more reliable pulse rate readings ([0065]).
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 (Verkruijsse as modified by Li and Addison) to incorporate the peak to peak measurements to both red and infrared plethysmography and average all the pulse rate data as taught by Shah, since both systems are oximetry devices and one of ordinary skill in the art would have recognized that calculating heart rate data from both red and infrared waveforms and averaging the pulse rate data over a period of time would lead to more reliable pulse rate readings (see Shah). The rationale would have been to obtain more reliable pulse rate information.
Response to Arguments
Applicant’s arguments, see page 8 of Remarks, filed on 11/14/2025, with respect to claims 2-3 and 7-11 have been fully considered and are persuasive. The 35 USC 112(b) rejection of claims 2-3 and 7-11 has been withdrawn.
Applicant’s amendment and argument with respect to claims 1, 19 and 20 filed on 11/14/2025 have been fully considered but they are deemed to be moot in views of the new grounds of rejection. It is noted that applicant alleged the medical event includes “a seizure, pain, stress, or other conditions based on facial features, body position” in the original filed Specification Paragraph [0065], see the page 9 of Remarks filed in 11/14/2025. However, it is improper to import limitations from the specification into the claims (see MPEP 2111.01)). According to the descriptions of [0065], “the alerts can also indicate if a patient may be experiencing a seizure, pain, stress, or other conditions based on facial features, body position, and the like”, which is not considered as special definition of the “medical event”. Therefore, “medical event” is rejected according to the BRI of the phrase for the examination.
In regard to the 35 USC 101 rejection, applicant alleged that that the analysis should have ended at step 2A1 and the generating steps/functions was not analyzed in step 2A1 but was in step 2A2. In response, as indicated in steps 2A2 above, “the generate alert steps/ functions (claims 1 and 19-20) are considered as insignificant extra-solution activity. According to MPEP 2106.05(g), “the addition of insignificant extra-solution activity does not amount to an inventive concept”. Furthermore, the generation of alert when monitored physiological information of the user cross a threshold/ predetermined range and the alert itself indicates the current physiological conditions of the user is a common extra-solution activity in the medical /pulse oximetry fields (see at least Addison and Shah). Therefore, the 35 USC 101 rejections are maintained for the reasons of record.
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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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791