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 .
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 6-20 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Shelton IV et al. (hereinafter ‘Shelton’, U.S. PGPub No. 2022/0237999).
In regards to claim 1, Shelton discloses a system (e.g., without arterial line and pressure cuff) comprising: an elastomeric substrate having a first side configured to be placed in contact with a skin region of a user (e.g., having a size to place to a substantial portion of a sternum) for a period of time of at least one day, the elastomeric substrate formed of one or more layers and having defined a sensor port at a first sensor region ([0346]: "In the case of a sensing system with an ECG-based sensor assembly 20312, a set of electrodes may be placed in contact with skin. The sensing system 20310 may measure voltages across the set of electrodes placed on the skin to determine heart rate."), a flexible photoplethysmographic circuit assembly configured with photodiodes, a photoplethysmographic circuit, and a forcing membrane, the flexible photoplethysmographic circuit assembly being configured to measure photoplethysmographic (PPG), wherein the flexible circuit assembly is positioned on the elastomeric substrate such that the photodiodes are contact-able to the skin region at the sensor port for the sensor region, and wherein the forcing membrane is in mechanical contact (e.g., directly or indirectly over a tuning spring) and positioned over the photodiodes to urge the photodiodes toward the skin region ([0039]: "The one or more sensing systems 20001 may measure the biomarkers 20005 using one or more sensors, for example, photosensors (e.g., photodiodes, photoresistors), mechanical sensors (e.g., motion sensors), acoustic sensors, electrical sensors, electrochemical sensors, thermoelectric sensors, infrared sensors, etc. The one or more sensors may measure the biomarkers 20005 as described herein using one of more of the following sensing technologies: photoplethysmography, electrocardiography, electroencephalography, colorimetry, impedimentary, potentiometry, amperometry, etc.", [0345]: "FIG. 11B is an example of a wristband-type sensing system 20310 comprising a sensor assembly 20312 (e.g., Photoplethysmography (PPG)-based sensor assembly or Electrocardiogram (ECG) based-sensor assembly). For example, in the sensing system 20310, the sensor assembly 20312 may collect and analyze arterial pulse in the wrist."), a stretchable electrode array assembly formed in the elastomeric substrate comprising a stretchable electrode array, configured to contact the skin region of the user at a second sensor region, the stretchable electrode array assembly being configured to measure electrocardiographic (ECG), wherein the electrode array is formed by one or more conformable electrodes having a meandering pattern configured to be in a first meandering configuration when placed on the skin and a second meandering configuration when stretched from the first meandering configuration ([0346]: "In the case of a sensing system with an ECG-based sensor assembly 20312, a set of electrodes may be placed in contact with skin. The sensing system 20310 may measure voltages across the set of electrodes placed on the skin to determine heart rate."), and a controller operatively coupled to the flexible photoplethysmographic circuit assembly and the stretchable electrode array assembly (e.g., directly or through a network), the controller having: a processor ([0267]: "The computer system 20063 may comprise a processor 20102 and a network interface 20100.", [0347]: "The sensing system 20310 may use a signal conditioning unit to filter and amplify the analog PPG signal, a microcontroller to digitize the analog PPG signal, and a wireless (e.g., a Bluetooth) module to transfer the data to a surgical hub or a computing device, for example, as described in FIGS. 7B through 7D."), and a memory having instructions stored thereon, wherein execution of the instructions causes the processor to receive, by the processor, measured ECG and PPG signals ([0345]: "The sensor assembly 20312 may be used to measure one or more biomarkers (e.g., heart rate, heart rate variability (HRV), etc.). In case of a sensing system with a PPG-based sensor assembly 20312, light (e.g., green light) may be passed through the skin."), determine, via a trained Al model, estimated blood pressure for the period of time of at least one day using the measured ECG and PPG signals as input to the trained Al model ([0408]: "The sensor assembly 20312 may be used to measure one or more biomarkers (e.g., heart rate, heart rate variability (HRV), etc.). In case of a sensing system with a PPG-based sensor assembly 20312, light (e.g., green light) may be passed through the skin.", [0404] - [0418]), and determine heart rate parameter, respiration rate parameter, heart rate variability parameter, and blood oxygen saturation parameter, from the measured ECG and/or PPG signals for the period of time of at least one day, wherein the determined heart rate parameter, respiration rate parameter, heart rate variability parameter, blood oxygen saturation parameter, and estimated blood pressure are outputted to provide a prolonged vital sign monitor for the user for the period of time of at least one day ([0235]: "The surgeon sensing systems 20020 may include sensing systems to monitor and detect a set of physical states and/or a set of physiological states of a healthcare provider (HCP). An HCP may be a surgeon or one or more healthcare personnel assisting the surgeon or other healthcare service providers in general. In an example, a sensing system 20020 may measure a set of biomarkers to monitor the heart rate of an HCP.").
In regards to claim 2, Shelton discloses the controller is physically coupled to the electrode array assembly and the flexible photoplethysmographic circuit in a single integrated sensor-controller device ([0281]: "As shown in FIG. 6B, a sensing system 20069 may include a processor 20110. The processor 20110 may be coupled to a radio frequency (RF) interface 20114, storage 20113, memory (e.g., a non-volatile memory) 20112, and I/O interface 20111 via a system bus. The system bus can be any of several types of bus structure(s) including the memory bus or memory controller, a peripheral bus or external bus, and/or a local bus, as described herein. The processor 20110 may be any single-core or multicore processor as described herein.").
In regards to claim 3, Shelton discloses that the controller is implemented in a mobile device (e.g., tablet, smartphone) comprising a network interface configured to communicatively operate with the electrode array assembly and the flexible photoplethysmographic circuit through a network ([0260]: "In examples, the operating theater devices 1a-1n/2a-2m and/or the sensing systems 20069 may communicate to the modular communication hub 20065 via Bluetooth wireless technology standard for exchanging data over short distances (using short-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz) from fixed and mobile devices and building personal area networks (PANs).").
In regards to claim 4, Shelton discloses that the controller is a remote computing device located in a cloud infrastructure comprising a network interface configured to communicatively operate with the electrode array assembly and the flexible photoplethysmographic circuit through a network ([0241]: "One or more of the patient sensing systems 20041-20045 may be send the measured data associated with the patient biomarkers being monitored to the computing device 20047, which in turn may be in communication with a remote server 20009 of the remote cloud computing system 20008.").
In regards to claim 6, Shelton discloses that the one or more conformable electrodes are formed of (i) a serpentine-patterned structure at a first end and (ii) a terminal at a second end ([0346]: "In the case of a sensing system with an ECG-based sensor assembly 20312, a set of electrodes may be placed in contact with skin. The sensing system 20310 may measure voltages across the set of electrodes placed on the skin to determine heart rate. HRV in this case may be measured as the time period variation (e.g., standard deviation) between R peaks in the QRS complex, known as R-R intervals.").
In regards to claim 7, Shelton discloses that each serpentine-patterned structure of the one or more conformable electrodes is formed of a first layer comprising a metal and a second layer comprising a polyimide ([0229]: "Suitable image sensors may include, but are not limited to, Charge-Coupled Device (CCD) sensors and Complementary Metal-Oxide Semiconductor (CMOS) sensors.").
In regards to claim 8, Shelton discloses that the determined heart rate parameter, respiration rate parameter, heart rate variability parameter, blood oxygen saturation parameter, and estimated blood pressure are employed for ambulatory care monitoring ([0241]: "FIG. 2C shows an example of a patient monitoring system (e.g., an uncontrolled patient monitoring system 20004). As illustrated in FIG. 2C, a patient in an uncontrolled environment (e.g., a patient's residence) is being monitored by a plurality of patient sensing systems 20041-20045.").
In regards to claim 9, Shelton discloses that the determined heart rate parameter, respiration rate parameter, heart rate variability parameter, blood oxygen saturation parameter, and estimated blood pressure are employed for health monitoring (e.g., postpartum monitoring) ([0235]: "The surgeon sensing systems 20020 may include sensing systems to monitor and detect a set of physical states and/or a set of physiological states of a healthcare provider (HCP). An HCP may be a surgeon or one or more healthcare personnel assisting the surgeon or other healthcare service providers in general. In an example, a sensing system 20020 may measure a set of biomarkers to monitor the heart rate of an HCP.").
In regards to claim 10, Shelton discloses that the trained AI model comprises a neural network ([0364]: "For example, a neural network (NN) algorithm (e.g., multilayer perceptrons (MLP)) for classification may include a hypothesis function represented by a network of layers of nodes that are assigned with biases and interconnected with weight connections.").
In regards to claim 11, Shelton discloses that the respiration rate parameter is determined from an amplitude modulation operation of R-peaks in the measured ECG signal ([0346]: "HRV in this case may be measured as the time period variation (e.g., standard deviation) between R peaks in the QRS complex, known as R-R intervals.").
In regards to claim 12, Shelton discloses a method comprising: receiving, by a processor, measured ECG and PPG signals from a stretchable electrode array assembly and a flexible photoplethysmographic circuit assembly, respectively ([0345]: "The sensor assembly 20312 may be used to measure one or more biomarkers (e.g., heart rate, heart rate variability (HRV), etc.). In case of a sensing system with a PPG-based sensor assembly 20312, light (e.g., green light) may be passed through the skin."), determining, via a trained AI model, estimated blood pressure for a period of time of at least one day using the measured ECG and PPG signals as input to the trained AI model ([0408]: "The sensor assembly 20312 may be used to measure one or more biomarkers (e.g., heart rate, heart rate variability (HRV), etc.). In case of a sensing system with a PPG-based sensor assembly 20312, light (e.g., green light) may be passed through the skin.", [0404] - [0418]), and determining heart rate parameter, respiration rate parameter, heart rate variability parameter, and blood oxygen saturation parameter, from the measured ECG and/or PPG signals for the period of time of at least one day, wherein the determined heart rate parameter, respiration rate parameter, heart rate variability parameter, blood oxygen saturation parameter, and estimated blood pressure are outputted to provide a prolonged vital sign monitor for a user for the period of time of at least one day ([0235]: "The surgeon sensing systems 20020 may include sensing systems to monitor and detect a set of physical states and/or a set of physiological states of a healthcare provider (HCP). An HCP may be a surgeon or one or more healthcare personnel assisting the surgeon or other healthcare service providers in general. In an example, a sensing system 20020 may measure a set of biomarkers to monitor the heart rate of an HCP.").
In regards to claim 13, Shelton discloses that one or more conformable electrodes of the stretchable electrode array assembly are formed of (i) a serpentine-patterned structure at a first end and (ii) a terminal at a second end ([0346]: "In the case of a sensing system with an ECG-based sensor assembly 20312, a set of electrodes may be placed in contact with skin. The sensing system 20310 may measure voltages across the set of electrodes placed on the skin to determine heart rate. HRV in this case may be measured as the time period variation (e.g., standard deviation) between R peaks in the QRS complex, known as R-R intervals.").
In regards to claim 14, Shelton discloses that each serpentine-patterned structure of the one or more conformable electrodes is formed of a first layer comprising a metal and a second layer comprising a polyimide ([0229]: "Suitable image sensors may include, but are not limited to, Charge-Coupled Device (CCD) sensors and Complementary Metal-Oxide Semiconductor (CMOS) sensors.").
In regards to claim 15, Shelton discloses that the determined heart rate parameter, respiration rate parameter, heart rate variability parameter, blood oxygen saturation parameter, and estimated blood pressure are employed for ambulatory care monitoring ([0241]: "FIG. 2C shows an example of a patient monitoring system (e.g., an uncontrolled patient monitoring system 20004). As illustrated in FIG. 2C, a patient in an uncontrolled environment (e.g., a patient's residence) is being monitored by a plurality of patient sensing systems 20041-20045.").
In regards to claim 16, Shelton discloses that the determined heart rate parameter, respiration rate parameter, heart rate variability parameter, blood oxygen saturation parameter, and estimated blood pressure are employed for health monitoring (e.g., postpartum monitoring) ([0235]: "The surgeon sensing systems 20020 may include sensing systems to monitor and detect a set of physical states and/or a set of physiological states of a healthcare provider (HCP). An HCP may be a surgeon or one or more healthcare personnel assisting the surgeon or other healthcare service providers in general. In an example, a sensing system 20020 may measure a set of biomarkers to monitor the heart rate of an HCP.").
In regards to claim 17, Shelton discloses that the trained AI model comprises a neural network ([0364]: "For example, a neural network (NN) algorithm (e.g., multilayer perceptrons (MLP)) for classification may include a hypothesis function represented by a network of layers of nodes that are assigned with biases and interconnected with weight connections. ").
In regards to claim 18, Shelton discloses that the respiration rate parameter is determined from an amplitude modulation operation of R-peaks in the measured ECG signal ([0346]: "HRV in this case may be measured as the time period variation (e.g., standard deviation) between R peaks in the QRS complex, known as R-R intervals.").
In regards to claim 19, Shelton discloses a non-transitory computer-readable medium having instructions stored thereon, wherein execution of the instructions by a processor causes the processor to:receive, by a processor, measured ECG and PPG signals, measured ECG and PPG signals from a stretchable electrode array assembly and a flexible photoplethysmographic circuit assembly, respectively;determine, via a trained AI model, estimated blood pressure for a period of time of at least one day using the measured ECG and PPG signals as input to the trained AI model ([0345]: "The sensor assembly 20312 may be used to measure one or more biomarkers (e.g., heart rate, heart rate variability (HRV), etc.). In case of a sensing system with a PPG-based sensor assembly 20312, light (e.g., green light) may be passed through the skin."), anddetermine heart rate parameter, respiration rate parameter, heart rate variability parameter, and blood oxygen saturation parameter, from the measured ECG and/or PPG signals for the period of time of at least one day,wherein the determined heart rate parameter, respiration rate parameter, heart rate variability parameter, blood oxygen saturation parameter, and estimated blood pressure are outputted to provide a prolonged vital sign monitor for a user for the period of time of at least one day ([0235]: "The surgeon sensing systems 20020 may include sensing systems to monitor and detect a set of physical states and/or a set of physiological states of a healthcare provider (HCP). An HCP may be a surgeon or one or more healthcare personnel assisting the surgeon or other healthcare service providers in general. In an example, a sensing system 20020 may measure a set of biomarkers to monitor the heart rate of an HCP.", [0408]: "The sensor assembly 20312 may be used to measure one or more biomarkers (e.g., heart rate, heart rate variability (HRV), etc.). In case of a sensing system with a PPG-based sensor assembly 20312, light (e.g., green light) may be passed through the skin.", [0404] - [0418]).
In regards to claim 20, Shelton discloses that one or more conformable electrodes of the stretchable electrode array assembly are formed of (i) a serpentine- patterned structure at a first end and (ii) a terminal at a second end ([0346]: "In the case of a sensing system with an ECG-based sensor assembly 20312, a set of electrodes may be placed in contact with skin. The sensing system 20310 may measure voltages across the set of electrodes placed on the skin to determine heart rate. HRV in this case may be measured as the time period variation (e.g., standard deviation) between R peaks in the QRS complex, known as R-R intervals.").
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of Hyde et al. (hereinafter ‘Hyde’, U.S. PGPub No. 2017/0164876).
In regards to claim 5, Shelton discloses the invention substantially as described in claim 1.
However, Shelton does not disclose using an adhesive on a side of the substrate for the health monitoring system.
Hyde teaches using a substrate in a device for health monitoring that can be affixed to skin via an adhesive material ([0137]: "The substrate 1002 can be positioned in proximity with the skin surface according to various mechanisms including, but not limited to, affixed to the skin via an adhesive material, and held in place by an external pressure, such as pressure provided by a material wrapped around the body portion (e.g., a fabric, a garment, etc.)."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the health monitoring system to use an adhesive on a side of the substrate, as taught by Hyde, as doing so would provide an efficient way for the system to be fixed to the skin of the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN M LEE whose telephone number is (703)756-1789. The examiner can normally be reached 9:00 am - 6:00 pm.
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/B.M.L./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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