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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 17, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-12 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites “the optical oxygenation sensors each non-invasively obtain information related to in-situ blood oxygenation from within a vein and/or artery of the wearer” (lines 10-13), which encompasses a human organism as part of the claimed invention. In order to overcome this rejection, Examiner suggests amending the claim language to recite “the optical oxygenation sensors are each configured to non-invasively obtain information related to in-situ blood oxygenation from within a vein and/or artery of the wearer”.
Claim 11 recites “the flexible electronic tattoo does not apply any pressure to the location on the skin of the wearer” (lines 1-3), which encompasses a human organism as part of the claimed invention. In order to overcome this rejection, Examiner suggests amending the claim language to recite “the flexible electronic tattoo is not configured to apply any pressure to the location on the skin of the wearer”.
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.
Claims 1-24 are 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.
Claim 1 recites the limitation "the interface" in lines 14-15. There is insufficient antecedent basis for this limitation in the claim. The claim recites that “a communication interface is mounted on the interface”, however it is unclear what element “the interface” is referencing.
Claim 4 recites “modify extracted venous blood oxygenation (SVO2) and arterial blood oxygenation (SaO2)” in lines 4-6. It is unclear if these terms are meant to refer to the SVO2 and SaO2 in claim 1, or if these are different extracted SVO2 and SaO2 values.
Claim 4 is rejected as failing to define the invention in the manner required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. The claim is narrative in form and replete with indefinite language. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claim must be in one sentence form only. As written, claim 4 includes multiple sentences. Additionally, claim 4 includes the language “(special filtering and source separation)” in lines 6-7 and it is unclear how this parenthetical language is meant to be incorporated into the claim. For the purpose of examination, only the first sentence of claim 4 prior to the parenthetical language will be considered as part of the claim.
Claim 6 recites the term “it” in line 5, which renders the claim indefinite, as it is unclear was “it” is referencing. Further clarification is required. For the purpose of examination “it” is intended to mean the oxygenation information.
Claim 13 recites the limitation "the interface" in lines 15-16. There is insufficient antecedent basis for this limitation in the claim. The claim recites that “a communication interface is mounted on the interface”, however it is unclear what element “the interface” is referencing.
Claim 16 recites “modify extracted venous blood oxygenation (SVO2) and arterial blood oxygenation (SaO2)” in lines 4-6. It is unclear if these terms are meant to refer to the SVO2 and SaO2 in claim 13, or if these are different extracted SVO2 and SaO2 values.
Claim 16 is rejected as failing to define the invention in the manner required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. The claim is narrative in form and replete with indefinite language. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claim must be in one sentence form only. As written, claim 16 includes multiple sentences. Additionally, claim 16 includes the language “(special filtering and source separation)” in lines 6-7 and it is unclear how this parenthetical language is meant to be incorporated into the claim. For the purpose of examination, only the first sentence of claim 16 prior to the parenthetical language will be considered as part of the claim.
Claim 18 recites the term “it” in line 5, which renders the claim indefinite, as it is unclear was “it” is referencing. Further clarification is required. For the purpose of examination “it” is intended to mean the oxygenation information.
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.
Claims 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over US 20260026756 A1 (Sen et al.) in view of US 20190183430 A1 (Alphonse et al.).
Regarding claim 1, Sen teaches a pressureless, non-invasive system for simultaneous extraction and measurement of arterial and venous blood oxygenation, comprising:
a flexible conformable substrate, wherein the substrate is configured to conform to and adhere to a location on a skin of a wearer ([0065] “the system may include a shell that attaches to the patient and has a form factor such as a patch”);
a plurality of optical oxygenation sensors mounted on the substrate, wherein the optical oxygenation sensors each non-invasively obtain information related to in-situ blood oxygenation from within a vein and/or artery of the wearer ([0020]; [0074] “an optical sensor that includes a photodiode and a light source (e.g., a light-emitting diode, or LED) in the visible/infrared spectrum. Here, the optical sensor can measure a photoplethysmogram (PPG) from the patient, which is a time-dependent waveform indicating blood flow in an artery or capillary located close to the surface of the infant's skin”; [0108] “the sensor device 300 may be or include a patch that may be configured to adhere or otherwise contact the patient 500. The sensor device 300 may include the electrodes 310A, 310B, 320A, 320B, the electronics (e.g., microcontroller and/or communication module) 390, and an optical sensor 610.”);
a communications interface mounted on the interface, wherein the communications interface is in communication with the plurality of optical oxygenation sensors ([0108] “the electronics (e.g., microcontroller and/or communication module) 390, and an optical sensor 610.”) and
a power source mounted on the flexible conformable substrate ([0100] “the (e.g., inside of the) sensor device 300 may include a printed circuit board 390 including a controller, a battery, and/or wireless communication module”; [0114]); and
one or more processors, wherein the one or more processors receive the information related to the in-situ blood oxygenation from within the vein and/or artery of the wearer through the communications interface and simultaneously extract venous blood oxygenation (SvO2) and arterial blood oxygenation (SaO2) from the information related to the in-situ blood oxygenation from within the vein and/or artery of the wearer ([0020] “The method also includes determining an arterial blood oxygen saturation based at least partially upon the PPG waveform … The method also includes determining a venous blood oxygen saturation based at least partially upon the total blood volume.”; [0081]; [0121]; [0129] “The venous oxygen saturation (SvO.sub.2) may be determined based at least partially upon the oxygen saturation of the venous blood”; [0148] “The processor is configured to process the third signal or a signal derived therefrom with a third algorithm to determine an oxygen saturation in blood or a region of tissue of the patient.”).
Sen does not explicitly teach a flexible electronic tattoo.
However,
Alphonse teaches a flexible electronic tattoo ([0164] “The stretchable/flexible epidermal electronic devices 115, 125 may be utilized for any sport or activity and the flexible wearable devices 115, 125 may be within kinesiology tape, small band aids, electronic tattoos, smart stickers or smart patches”; [0171] “the wearable devices 115, 125 may be electronic tattoo- include flexible tattoo like circuits and flexible sensors.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system comprising a wearable patch taught by Sen to include the patch being an electronic tattoo. One would have been motivated to make this modification because electronic tattoos can be used for oxygen monitoring to provide data to physicians as well as gather oxygen data in hospital settings while naturally moving with the skin, as suggested by Alphonse ([0047], [0171]).
Regarding claim 2, Sen teaches the system of claim 1, wherein the one or more processors make a determination about oxygen saturation of a localized area proximate the location on the skin of the wearer where the electronic tattoo is adhered based on observed optical absorptions ([0020] “The one or more photodiodes are configured to measure the one or more optical signals in response to absorption of the light underneath the skin of the patient … The method also includes determining an arterial blood oxygen saturation based at least partially upon the PPG waveform”; [0086]; [0134] “The patient monitoring system 1700 may include a processor and a display. The patient monitoring system 1700 may include or be connected to a first optical biosensor patch 1702A that may be attached to the patient's abdomen. The first biosensor 1702A may be configured to measure PPG and/or NIRS signals in the abdominal region”; [0140] “The system may filter and/or process the signals to obtain one or more single data points or waveforms from one or more of: arterial oxygen saturation, total hemoglobin content, total blood content, blood oxygen saturation, venous oxygen saturation, or a combination thereof.”).
Regarding claim 3, Sen teaches the system of claim 2, wherein the determination about oxygen saturation comprises a one-dimensional (1D) distribution of absorbance changes, or a two-dimensional (2D) image of absorbance changes of the localized area (Fig. 10 [0112] “absorption spectra of water, melanin, oxyhemoglobin (HbO2), and deoxyhemoglobin (Hb).”; [0113] “The method may also include (at further time stamps) continue to collect digitally-converted data from the sensor module for a predetermined period of time to generate waveforms of the monitored parameters, as at 1120. The method may also include using the digital sensor data and waveform data to determine direct physiological parameters (e.g., HR, RR, SpO2, regSpO2, SV, other) based on predetermined functions, as at 1130.”).
Regarding claim 4, Sen teaches the system of claim 2, wherein the information related to the in-situ blood oxygenation from within the vein and/or artery of the wearer from each of the plurality of optical oxygenation sensors is used to modify extracted venous blood oxygenation (SvO2) and arterial blood oxygenation (SaO2) estimations from nearby sensors (spatial filtering and source separation). This is required because the light diffuses/scatters through a large volume of tissue and the artery and vein are very close to each other, resulting in crosstalk or a mixture of signals ([0134] “two biosensors (e.g., patches including biosensor(s)) attached to the chest and abdomen of the patient 500, according to an embodiment.”; [0140] “the system may be used to monitor a patient and may include a NIRS sensor and a PPG sensor that are each configured to measure optical signals from the patient. The system may filter and/or process the signals to obtain one or more single data points or waveforms from one or more of: arterial oxygen saturation, total hemoglobin content, total blood content, blood oxygen saturation, venous oxygen saturation, or a combination thereof. The data (e.g., data points and/or waveforms) may be used to measure/estimate the A-V (arterial-venous) ratio of the patient”).
Regarding claim 5, Sen teaches the system of claim 2, wherein the localized area comprises the neck, chest, back, stomach, upper arm, upper leg, or lower leg of the wearer ([0109] “the patient 500 wearing one or more sensor device 300A, 300B (e.g., wearable patches on the belly and the chest)”; [0134]).
Regarding claim 6, Sen teaches the system of claim 1, further comprising a peripheral sensor, separate from the flexible electronic tattoo, wherein the peripheral sensor non-invasively obtains oxygenation information related to a peripheral site of the wearer and provides it to the one or more processors, wherein the one or more processors calibrate one or more of the plurality of oxygenation sensors based on the oxygenation information about the peripheral site ([0011] “The monitor can also measure oxygen saturation using a pulse oximeter, generally placed in an area of high vasculature (e.g., fingers, toes). A pulse oximeter has a light source with at least two light sources in the red/infrared range (e.g., 660 nm and 900 nm) and a photodetector used to measure optical changes that correspond to changes in blood oxygen concentration, from which the SpO2 value is derived as a percentage.”; [0020] “A light emitter is configured to emit light toward a skin of the patient. The one or more photodiodes are configured to measure the one or more optical signals in response to absorption of the light underneath the skin of the patient. The method also includes determining a photoplethysmography (PPG) waveform and a near-infrared spectroscopy (NIRS) waveform based at least partially upon the one or more optical signals.”; [0056]; [0135] “The system 1700 may include or be connected to a pulse oximeter 1704 that may be attached to the patient's index finger. The patient monitoring system 1700 may be configured to provide cardiac, vascular, and/or respiratory monitoring of the patient”).
Regarding claim 7, Sen teaches the system of claim 6, wherein the peripheral site comprises a fingertip, earlobe or toe of the wearer ([0011] “The monitor can also measure oxygen saturation using a pulse oximeter, generally placed in an area of high vasculature (e.g., fingers, toes).”; [0056] “FIG. 17B illustrates a schematic view of the patient monitoring system including a biosensor (e.g., a patch including biosensor(s)) attached to the abdomen of the patient and a pulse oximeter sensor attached to the finger of the patient, according to an embodiment.”; [0135]).
Regarding claim 8, Sen teaches the system of claim 6, wherein the one or more processors are not mounted on the flexible electronic tattoo and/or the peripheral sensor ([0070] “a processing component that processes information generated by the first, second, and third sensors; and ii) a computing component configured to avail content determined by the processing component on a network. A software application operating on a remote computer connects to the network and receives and then displays content availed by the computing component, or parameters calculated therefrom”; [0083] “The processing component within the monitoring module may be a computer (e.g., a single-board computer) that operates a collection of algorithms and software programs”).
Regarding claim 9, Sen teaches the system of claim 6, wherein each of the plurality of oxygenation sensors and the peripheral sensor comprise multiple photoplethysmography (PPG) sensors ([0010] “This infant monitor includes a wireless sensory sock that measures photoplethysmography (PPG)”; [0011]; [0120] “PPG sensors”; [0134-0135]).
Regarding claim 10, Sen teaches the system of claim 6, wherein the plurality of oxygenation sensors, and the peripheral sensor communicate wirelessly with the one or more processors ([0065] “The microcontroller within the control module collects digital representations of these signals, and then ports them through a wireless interface for further analysis, as described below.”; [0070] “wireless transmitter configured to receive and wirelessly transmit information from the first, second, and third sensors.”).
Regarding claim 11, Sen teaches the system of claim 1.
Sen does not explicitly teach wherein the flexible electronic tattoo does not apply any pressure to the location on the skin of the wearer.
However,
Alphonse teaches wherein the flexible electronic tattoo does not apply any pressure to the location on the skin of the wearer ([0166] “The wearable tattoo label is befitting of the devices because they adhere to the skin in a way that they do not appear to be a device. The devices may be so flush with the skin they move 1:1 with the skin and appear as if they are an actual tattoo embedded on the user's skin.”)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system comprising a wearable patch taught by Sen to include the patch being a pressureless electronic tattoo. One would have been motivated to make this modification because the electronic tattoo has the ability to move 1:1 with the skin to feel natural while gathering biometric data, as suggested by Alphonse ([0009, 0166]).
Regarding claim 12, Sen teaches the system of claim 1, wherein the information related to the in-situ blood oxygenation from within the vein of the wearer and/or the information related to the in-situ blood oxygenation from within the artery of the wearer comprise venous and arterial pulse waveforms, respectively ([0140] “The system may filter and/or process the signals to obtain one or more single data points or waveforms from one or more of: arterial oxygen saturation, total hemoglobin content, total blood content, blood oxygen saturation, venous oxygen saturation, or a combination thereof. The data (e.g., data points and/or waveforms) may be used to measure/estimate the A-V (arterial-venous) ratio of the patient”).
Regarding claim 13, Sen teaches a method for using a pressureless, non-invasive system for simultaneous extraction and measurement of arterial and venous blood oxygenation, the method comprising:
a flexible conformable substrate, wherein the substrate is configured to conform to and adhere to a location on a skin of a wearer ([0065] “the system may include a shell that attaches to the patient and has a form factor such as a patch”);
a plurality of optical oxygenation sensors mounted on the substrate, wherein the optical oxygenation sensors each non-invasively obtain information related to in-situ blood oxygenation from within a vein and/or artery of the wearer ([0020]; [0074] “an optical sensor that includes a photodiode and a light source (e.g., a light-emitting diode, or LED) in the visible/infrared spectrum. Here, the optical sensor can measure a photoplethysmogram (PPG) from the patient, which is a time-dependent waveform indicating blood flow in an artery or capillary located close to the surface of the infant's skin”; [0108] “the sensor device 300 may be or include a patch that may be configured to adhere or otherwise contact the patient 500. The sensor device 300 may include the electrodes 310A, 310B, 320A, 320B, the electronics (e.g., microcontroller and/or communication module) 390, and an optical sensor 610.”);
a communications interface mounted on the interface, wherein the communications interface is in communication with the plurality of optical oxygenation sensors ([0108] “the electronics (e.g., microcontroller and/or communication module) 390, and an optical sensor 610.”); and
a power source mounted on the flexible conformable substrate ([0100] “the (e.g., inside of the) sensor device 300 may include a printed circuit board 390 including a controller, a battery, and/or wireless communication module”; [0114]); and
receiving, by one or more processors, the information related to the in-situ blood oxygenation from within the vein and/or artery of the wearer through the communications interface ([0065] “The microcontroller within the control module collects digital representations of these signals, and then ports them through a wireless interface for further analysis, as described below”; [0148] “The processor is configured to process the third signal or a signal derived therefrom with a third algorithm to determine an oxygen saturation in blood or a region of tissue of the patient.”); and
simultaneously extracting, by the one or more processors, venous blood oxygenation (SvO2) and arterial blood oxygenation (SaO2) from the information related to the in-situ blood oxygenation from within the vein and/or artery of the wearer ([0020] “The method also includes determining an arterial blood oxygen saturation based at least partially upon the PPG waveform … The method also includes determining a venous blood oxygen saturation based at least partially upon the total blood volume.”; [0081]; [0121]; [0129] “The venous oxygen saturation (SvO.sub.2) may be determined based at least partially upon the oxygen saturation of the venous blood”).
Sen does not explicitly teach attaching flexible electronic tattoo to an epidermis of a wearer, proximate an artery and a vein of the wearer.
However,
Alphonse teaches attaching flexible electronic tattoo to an epidermis of a wearer, proximate an artery and a vein of the wearer ([0007] “the flexible wearable devices allow a user to not only measure what their arms do but also their other body parts, such as, but not limited to, their legs, head, thighs, calves, feet, other various muscle groups and other body parts”; [0048] “The wearable device 115 has the ability to track heart rate, punch and kick acceleration, utilize an internal power source, and be able to process and store the data. Every time blood is pumped from the heart, blood vessels expand due to the change in pressure and a pulse is generated. When blood flows back to the heart, another pulse occurs. This generates what is known as a photoplethysmography (PPG) signal, which is the superposition of both pulses and heart beat information and can be used to determine the heart rate.”; [0164] “the flexible wearable devices 115, 125 may be within kinesiology tape, small band aids, electronic tattoos, smart stickers or smart patches. A heart rate algorithm utilized by the system 100 differs from what is available due to the fact that if the wearable devices 115, 125 can be worn anywhere on the body”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system comprising a wearable patch taught by Sen to include the patch being an electronic tattoo. One would have been motivated to make this modification because electronic tattoos can be used for oxygen monitoring to provide data to physicians as well as gather oxygen data in hospital settings and they move naturally with the user’s skin, as suggested by Alphonse ([0047], [0171]).
Regarding claim 14, Sen teaches the method system of claim 12, wherein the one or more processors make a determination about oxygen saturation of a localized area proximate the location on the skin of the wearer where the electronic tattoo is adhered based on observed optical absorptions ([0020] “The one or more photodiodes are configured to measure the one or more optical signals in response to absorption of the light underneath the skin of the patient … The method also includes determining an arterial blood oxygen saturation based at least partially upon the PPG waveform”; [0086]; [0134] “The patient monitoring system 1700 may include a processor and a display. The patient monitoring system 1700 may include or be connected to a first optical biosensor patch 1702A that may be attached to the patient's abdomen. The first biosensor 1702A may be configured to measure PPG and/or NIRS signals in the abdominal region”; [0140] “The system may filter and/or process the signals to obtain one or more single data points or waveforms from one or more of: arterial oxygen saturation, total hemoglobin content, total blood content, blood oxygen saturation, venous oxygen saturation, or a combination thereof.”).
Regarding claim 15, Sen teaches the method of claim 13, wherein the determination about oxygen saturation comprises a one-dimensional (1D) distribution of absorbance changes, or a two-dimensional (2D) image of absorbance changes of the localized area (Fig. 10 [0112] “absorption spectra of water, melanin, oxyhemoglobin (HbO2), and deoxyhemoglobin (Hb).”; [0113] “The method may also include (at further time stamps) continue to collect digitally-converted data from the sensor module for a predetermined period of time to generate waveforms of the monitored parameters, as at 1120. The method may also include using the digital sensor data and waveform data to determine direct physiological parameters (e.g., HR, RR, SpO2, regSpO2, SV, other) based on predetermined functions, as at 1130.”).
Regarding claim 16, Sen teaches the method of claim 13, wherein the information related to the in-situ blood oxygenation from within the vein and/or artery of the wearer from each of the plurality of optical oxygenation sensors is used to modify extracted venous blood oxygenation (SvO2) and arterial blood oxygenation (SaO2) from nearby sensors (spatial filtering and source separation). This is required because the light diffuses/scatters through a large volume of tissue and the artery and vein are very close to each other, resulting in crosstalk or a mixture of signals ([0134] “two biosensors (e.g., patches including biosensor(s)) attached to the chest and abdomen of the patient 500, according to an embodiment.”; [0140] “the system may be used to monitor a patient and may include a NIRS sensor and a PPG sensor that are each configured to measure optical signals from the patient. The system may filter and/or process the signals to obtain one or more single data points or waveforms from one or more of: arterial oxygen saturation, total hemoglobin content, total blood content, blood oxygen saturation, venous oxygen saturation, or a combination thereof. The data (e.g., data points and/or waveforms) may be used to measure/estimate the A-V (arterial-venous) ratio of the patient”).
Regarding claim 17, Sen teaches the method of claim 13, wherein the localized area comprises the neck, chest, back, stomach, upper arm, upper leg, or lower leg of the wearer ([0109] “the patient 500 wearing one or more sensor device 300A, 300B (e.g., wearable patches on the belly and the chest)”; [0134]).
Regarding claim 18, Sen teaches the method of claim 12, further comprising a peripheral sensor, separate from the flexible electronic tattoo, wherein the peripheral sensor non-invasively obtains oxygenation information related to a peripheral site of the wearer and provides it to the one or more processors, wherein the one or more processors calibrate one or more of the plurality of oxygenation sensors based on the oxygenation information about the peripheral site ([0011] “The monitor can also measure oxygen saturation using a pulse oximeter, generally placed in an area of high vasculature (e.g., fingers, toes). A pulse oximeter has a light source with at least two light sources in the red/infrared range (e.g., 660 nm and 900 nm) and a photodetector used to measure optical changes that correspond to changes in blood oxygen concentration, from which the SpO2 value is derived as a percentage.”; [0020] “A light emitter is configured to emit light toward a skin of the patient. The one or more photodiodes are configured to measure the one or more optical signals in response to absorption of the light underneath the skin of the patient. The method also includes determining a photoplethysmography (PPG) waveform and a near-infrared spectroscopy (NIRS) waveform based at least partially upon the one or more optical signals.”; [0056]; [0135] “The system 1700 may include or be connected to a pulse oximeter 1704 that may be attached to the patient's index finger. The patient monitoring system 1700 may be configured to provide cardiac, vascular, and/or respiratory monitoring of the patient”).
Regarding claim 19, Sen teaches the method of claim 17, wherein the peripheral site comprises a fingertip, earlobe or toe of the wearer ([0011] “The monitor can also measure oxygen saturation using a pulse oximeter, generally placed in an area of high vasculature (e.g., fingers, toes).”; [0056] “FIG. 17B illustrates a schematic view of the patient monitoring system including a biosensor (e.g., a patch including biosensor(s)) attached to the abdomen of the patient and a pulse oximeter sensor attached to the finger of the patient, according to an embodiment.”; [0135]).
Regarding claim 20, Sen teaches the method of claim 17, wherein the one or more processors are not mounted on the flexible electronic tattoo and/or the peripheral sensor ([0070] “a processing component that processes information generated by the first, second, and third sensors; and ii) a computing component configured to avail content determined by the processing component on a network. A software application operating on a remote computer connects to the network and receives and then displays content availed by the computing component, or parameters calculated therefrom”; [0083] “The processing component within the monitoring module may be a computer (e.g., a single-board computer) that operates a collection of algorithms and software programs”).
Regarding claim 21, Sen teaches the method of claim 17, wherein each of the plurality of oxygenation sensors and the peripheral sensor comprise multiple photoplethysmography (PPG) sensors ([0010] “This infant monitor includes a wireless sensory sock that measures photoplethysmography (PPG)”; [0011]; [0120] “PPG sensors”; [0134-0135]).
Regarding claim 22, Sen teaches the method of claim 17, wherein the plurality of oxygenation sensors, and the peripheral sensor communicate wirelessly with the one or more processors ([0065] “The microcontroller within the control module collects digital representations of these signals, and then ports them through a wireless interface for further analysis, as described below.”; [0070] “wireless transmitter configured to receive and wirelessly transmit information from the first, second, and third sensors.”).
Regarding claim 23, Sen teaches the method of claim 12.
Sen does not explicitly teach wherein the flexible electronic tattoo does not apply any pressure to the location on the skin of the wearer.
However,
Alphonse teaches wherein the flexible electronic tattoo does not apply any pressure to the location on the skin of the wearer ([0166] “The wearable tattoo label is befitting of the devices because they adhere to the skin in a way that they do not appear to be a device. The devices may be so flush with the skin they move 1:1 with the skin and appear as if they are an actual tattoo embedded on the user's skin.”)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the system comprising a wearable patch taught by Sen to include the patch being a pressureless electronic tattoo. One would have been motivated to make this modification because the electronic tattoo has the ability to move 1:1 with the skin to feel natural while gathering biometric data, as suggested by Alphonse ([0009, 0166]).
Regarding claim 24, Sen teaches the method of claim 12, wherein the information related to the in-situ blood oxygenation from within the vein of the wearer and/or the information related to the in-situ blood oxygenation from within the artery of the wearer comprise venous and arterial pulse waveforms, respectively ([0140] “The system may filter and/or process the signals to obtain one or more single data points or waveforms from one or more of: arterial oxygen saturation, total hemoglobin content, total blood content, blood oxygen saturation, venous oxygen saturation, or a combination thereof. The data (e.g., data points and/or waveforms) may be used to measure/estimate the A-V (arterial-venous) ratio of the patient”).
Conclusion
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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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