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 Objections
Claim 15 is objected to because of the following informalities: the abbreviation of “CPR” should be spelled out. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 –
Claims 6-9, 11, 12, 14-16, 20, 22, 23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tran et al [US 2020/0008299]
Claims 1-5. (Cancelled)
Claim 6. (Currently Amended) A system for pressure ulcer prevention and monitoring (reads upon the BI instruments include a pair of surface electrodes 11, 12 can be used in a variety of clinical applications such as to estimate body composition, to determine total body water, to assess compartmentalization of body fluids, to provide cardiac monitoring, measure blood flow, dehydration, blood pressure, blood loss, wound “or injury” monitoring, ulcer detection and deep vein thrombosis. The sensors are in direct contact with the skin surface, wherein the flexible BI ulcer detector can be integrated into a biocompatible, biodegradable form for hemodynamic monitoring of pressure and blood flow, (see Figs. 1, 5A-5F, para [0286, 0288]). The system determines healing wounds “or injuries” if the impedance and reactance of the wound “or injury” region increases as the skin region becomes dry (see para [0302]). Thus, the BI ulcer detection and monitoring wound on the person’s skin and blood pressure is functionally equivalent to the pressure ulcer, comprising:
a stretchable sensor array system comprising a stretchable substrate and one or more sensor arrays, each sensor array comprising a plurality of sensors deposited on the stretchable substrate (the flexible “stretchable” sensors array can include motion or position sensors, electrical signal sensors, pressure sensors, oxygen sensors, temperature sensor, array of BI sensors, and the like, see Figs. 5B, 5F, 13, para [0049-0058, 0166, 0188, 0284-0289, 0296]);
wherein each sensor comprises a conductive electrode that contains one or more
carbonaceous materials and is configured to respond to a parameter selected from pressure, temperature, humidity, and chemical substances (as cited above, and including the biosensors such as EKG/ECG electrodes, glucose test strips and pads for drug delivery manufactured by using combinations of silver, silver-silver chloride, carbon, and di-electric inks printed on thin film polyester have become the norm, a mercury-coated glassy carbon electrode, and single-walled carbon nanotubes (SWNT) applied as a coating to the working electrode, see Figs. 1, 2, para [0041, 0072, 0096, 0195]), and
wherein each sensor is in signal communication with a computing device or a cloud-
based platform for storing, processing, and analyzing data related to factors associated with pressure ulcer development (the cloud solution 4 including processing, storing and analysis sensed of ulcer data information, see Figs. 2, 5C-5D, para [0040-0043, 0235, 0241]),
wherein the data include pressure data over time, and wherein the computing device or the cloud-based platform is configured to analyze the data to predict pressure points that may lead to pressure ulcers (the various BI analysis methods can be used in a variety of clinical applications such as to estimate body composition, to determine total body water, to assess compartmentalization of body fluids, to provide cardiac monitoring, measure blood flow, dehydration, blood loss, wound monitoring, ulcer detection and deep vein thrombosis. Other uses for the BI sensor include detecting and/or monitoring hypovolemia, hemorrhage or blood loss. The impedance measurements, impedance changing can be made sequentially over a period of in time; and the system can determine whether the subject is externally or internally bleeding based on a change in measured impedance. The watch can also report temperature, heat flux, vasodilation and blood pressure along with the BI information (see para [0288, 0289]);
wherein one or more sensor arrays are affixed to a patient's skin or a device with which
the patient is in a physical contact with (the flexible sensor arrays such as BI sensors applied to a person skin, see Figs. 5C-5D, 5F, para [0098, 0101, 0197, 0286, 0287, 0377]); and
a patient or caregiver notification system operatively connected to the computing device
or the cloud-based platform, wherein the patient or caregiver notification system comprises at least one of an audible alarm, a visual indicator, and a tactile indicator (the tactile touched by a user or patient, see para [0177, 0317, 0340]). The automatically generate an audible and/or visible alert for a carer (e.g. presented on a screen of the user interface 108, see para [0211, 0280]).
Claim 7. (Currently Amended) The system of claim 6, wherein the computing device is a workstation or a handheld device (the user’s cellular phone 2, cloud computer solution 4 and remote user 5, see Fig. 2), and a software program is installed on the computer device for receiving, processing, and/or displaying data (programmable software computer to processing and displaying, see Figs. 1, 2, para [0025, 0036-0039, 0201, 0204, 0234]).
Claim 8. (Currently Amended) The system of claim 6, wherein the computing device or the cloud-based platform is configured to analyze data related to factors associated with pressure ulcer development by analyzing one or more of overall pressure distribution, patient body profiles (as cited in respect to claim 6 above, wherein the BI ulcer sensor inductance thus depends directly on the cross-sectional area being measured, and not indirectly on an area which changes as a result of the factors changing the measured cross-sectional area. Various physiological parameters of medical and research interest may be extracted from repetitive measurements of the areas of various cross-sections of the body. For example, pulmonary function parameters, such as respiration volumes and rates and apneas and their types, may be determined from measurements of, at least, a chest transverse cross-sectional area and also an abdominal transverse cross-sectional area. Cardiac parameters, such central venous pressure, left and right ventricular volumes waveforms, and aortic and carotid artery pressure waveforms, may be extracted from repetitive measurements of transverse cross-sectional areas of the neck and of the chest passing through the heart (see para [0288, 0296, 0307]); and
postures, pressure distribution during patient movements and position changes, time spent in a particular position, humidity levels and temperature levels, to predict pressure points (as cited in respect to claim 6 above, and including the motion or position sensors, electrical signal sensors, pressure sensors, temperature sensor, blood flow and blood velocity can be used to estimate blood pressure, which see para [0049-0058, 0166, 0188, 0284-0289, 0296, 0339]).
Claim 9. (Currently Amended) A method for preventing and monitoring pressure ulcers in a patient using the system of claim 6, comprising the steps of: applying one or more sensor arrays to a patient's skin or a device with which the patient is in a physical contact (as cited in respect to claim 6 above, and the flexible sensor arrays such as BI pressure ulcer sensors applied to a person skin, see Figs. 5C-5D, 5F, para [0098, 0101, 0197, 0286-288, 0302, 0377]);
detecting one or more parameters selected from pressure, temperature, humidity, and
volatile organic compounds (VOC) using the one or more sensor arrays (as cited in respect to claim 1 above, and including the VOC sensor, see para [0259]); and
transmitting sensor data to the computing device or the cloud-based platform (as cited in respect to claim 6 above, wherein the BI array sensors is/are communicating with local user’s handheld device 2, a cloud solution 4 and a remote user 5 for analyzing, processing and storing, see Fig. 2, para [0040, 0197, 0283]); and
analyzing the sensor data to predict pressure points that may lead to pressure ulcers (reads upon the estimate body composition, to determine total body water, to assess compartmentalization of body fluids, to provide cardiac monitoring, measure blood flow, dehydration, blood loss, wound monitoring, ulcer detection and deep vein thrombosis. Other uses for the BI sensors include detecting and/or monitoring hypovolemia, hemorrhage or blood loss. The impedance measurements can be made sequentially over a period of in time; and the system can determine whether the subject is externally or internally bleeding based on a change in measured impedance. The watch can also report temperature, heat flux, vasodilation and blood pressure along with the BI information, see para [0288]).
Claim 11. (Currently Amended) The method of claim 9, wherein the device with which the patient is in contact is selected from the group consisting of a bandage, a garment, a cushion, a mattress, a chair, a wheelchair, and a mattress topper, and the intervention comprises heating, cooling, vibration, massage, or changing a firmness level of the device (the bands and pads on the seat, see Figs. 2, 5C-5D, para [0089, 0091, 0099, 0201, 0270, 0343]).
Claim 12. (Currently Amended) A training simulator, comprising: a stretchable substrate; a sensor array comprising a plurality of pressure sensors deposited on or in the stretchable substrate (the bipolar or tetrapolar electrode systems used in the BI instruments include a pair of surface electrodes 11, 12, are in direct contact with the skin surface, wherein the flexible BI ulcer detector can be integrated into a biocompatible, biodegradable form for hemodynamic monitoring of pressure and blood flow, (see Figs. 5A-5F, para [0173, 0286]);
a computing device or the cloud-based platform operatively connected to the sensor array (the computer system or cloud-based structure 4, see Figs. 1, 2, para [0040, 0211]); and an object that a trainee interacts with during the training scenario, wherein pressure is applied to the object by the trainee, wherein the sensor array is affixed to or embedded in the object (the trained patient, person or user is attached or worn the flexible sensor device 1, the flexible sensor array, see Figs. 1, 2 5A-5F, para [0025, 0079-0084, 0166, 0200, 0212]),
wherein the plurality of pressure sensors are configured to detect pressure applied to the object during the training scenario and to output sensor data reflecting the applied pressure (the pressure sensors and BI instruments attached and applied to a user’s body for monitoring blood flow and blood pressure, see Figs. 1, 2, 5C-5F, para [0188, 0288]), and
wherein the computing device or the cloud-based platform is configured to process the sensor data and display processed data reflecting the pressure applied during the training scenario (as the pressure ulcer sensor or BI sensor indicated in claim 6 above, and the cellular phone, computer, PC, PDA, etc. to display data information to be monitored and observed sensed pressure data information including the movement and/or activities of a customer, patient, person, and/or user, see abstract, Figs. 1, 5D, 5L, para [0036, 0200, 0211, 0279]).
And in paragraph [2012] In yet a further embodiment for performing motor motion analysis, an HMM is used to determine the physical activities of a patient, to monitor overall activity levels and assess compliance with a prescribed exercise regimen and/or efficacy of a treatment program. A physician, clinician, or physical therapist “as a trainer” with access to patient data may remotely monitor compliance with the prescribed program or a standardized test on motor skill. For example, patients can take the Wolf Motor Function test and acceleration data is captured on the following tasks:
[0213] placing the forearm on a table from the side
[0214] moving the forearm from the table to a box on the table from the side
[0215] extending the elbow to the side
[0216] extending the elbow to the side against a light weight
[0217] placing the hand on a table from the front
[0218] moving the hand from table to box
[0219] flexing the elbow to retrieve a light weight
[0220] lifting a can of water
[0221] lifting a pencil, lifting a paper clip
[0222] stacking checkers, flipping cards
[0223] turning a key in a lock
[0224] folding a towel
[0225] lifting a basket from the table to a shelf above the table.
Claim 13. (Cancelled)
Claim 14. (Currently Amended) The training simulator of claim 12, wherein the object is selected from the group consisting of a manikin, a garment, a vest, and a helmet (the user can select to use jacket, vest, eye glasses, head-mounted display, see Figs. 5C-5H, para [0183, 0197, 0270, 0339, 0340]).
Claim 15. (Currently Amended) The training simulator of claim 12, wherein the training scenario selected from simulating surgical procedures, laparoscopy, and wound closure, monitoring pressure in orthopedic maneuvers, assessing pressure during intravenous catheter insertion and phlebotomy, providing feedback on compression depth in CPR training, simulating palpation during physical examination, preventing pressure injuries during patient positioning, simulating wound care, and evaluating pressure during obstetric simulations (as cited in respect to claims 12, 13 above, and including the automatic feedback controlling insulin delivery to a patient, feedback to bi-ventricular cardiac pacing devices, wound monitoring, patient injuries, ulcer detection and deep vein thrombosis, see Figs. 5C-5F, para [0097, 0288, 0299, 0302, 0307, 0336]).
Claim 16. (Currently Amended) A method for palpation simulation using the training simulator of claim 12, comprising: affixing the sensor array to or embedding the sensor array in the object, wherein the object is a manikin and the sensor array comprises a plurality of pressure sensors; performing the palpation training by applying pressure to the object at a location corresponding to the sensor array and causing the sensor array to transmit sensor data to the computing device or the cloud-based platform; and
processing the sensor data and displaying the processed data, wherein the processed data reflects pressure applied during the performance of palpation (as cited in respect to claims 9 and 12 above, wherein the performance of palpation reads upon the pressure sensing by electrode stimulation TENS device, light nanosensor, ulcer detection and deep vein thrombosis or any other suitable device, see Figs. 1, 2, 5A-5F, para [0087, 0172, 0288, 0305]).
Claims 17-19. (Cancelled)
Claim 20. (New) The method of claim 9, wherein analyzing the sensor data comprises analyzing one or more of overall pressure distribution, patient body profiles and postures, pressure distribution during patient movements and position changes, time spent in a particular position, humidity levels and temperature levels, to predict pressure points that may lead to pressure ulcers (as cited in respect to claim 8 above),
Claim 22. (New) The training simulator of claim 12, wherein the computing device or the cloud-based platform comprises software (the cloud-based structure and software, see Figs. 1, 2, para [0201, 0040, 0234]) configured to process data collected in real time (see para [0097, 0306]) and to provide outputs comprising heat maps or pressure-time graphs (reads upon the ECG BI electrode sensors to sense blood pressure and mapped in real-time, see para [0288, 0316, 0317, 0332]).
Claim 23. (New) The training simulator of claim 12, wherein the medical training scenario comprises one or more palpations selected from light palpation, deep palpation, light ballottement, and deep ballottement, and wherein the sensor array is configured to output data representative of the one or more palpations (as cited in respect to claims 12 and 16 above).
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 10, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al [US 2020/0008299]
Claim 10. (Currently Amended) The method of claim 9, wherein the analysis determines a duration of mobility or immobility of the patient, and one or more conditions selected form a temperature at or near a body part of the patient, a humidity at or near a body part of the patient, and VOCs emitted from a body part of the patient (as cited in respect to claim 9 above). But
Tran et al fails to disclose and further comprises the step of notifying the patient and/or a caregiver when the pressure-ulcer risk condition or one of the conditions reaches or exceeds a predetermined threshold value. However,
Tran et al teaches that the user interface may also include a transmitter which sends alerts to communication devices such as pagers or nurse phones carried by carers to indicate that there has been a wetness event, or that one is due to occur, or that physical inspection of the patient is required or due. In addition to the detection of wetness events which are estimated to exceed a threshold amount, these conditions warranting physical inspection may include when exudate is fecal in nature or when sensors detect blood, and the system can determine whether the subject is externally or internally bleeding based on a change in measured impedance. The watch can also report temperature, heat flux, vasodilation and blood pressure along with the BI ulcer information. (see para [0278, 0288]).
Therefore, it would have been obvious to one skill in the art to recognize that the determining and alerting of externally or internally blood bleeding detected by the BI ulcer detection that based on the exceeding a threshold amount, is functionally equivalent to the claim limitation of notifying the patient and/or a caregiver when the pressure-ulcer risk condition or one of the conditions reaches or exceeds a predetermined threshold value.
Claim 21. Tran et al fails to disclose generating an alert or recommendation for patient repositioning, or other interventions to prevent pressure ulcer. However,
Tran et al teaches that the EMG data is used to detect muscle fatigue and to generate a warning to the patient to get to a resting place or a notification to a nurse or caregiver to render timely assistance (see Figs. 5C-5D, para [0197, 0200]).
One embodiment that measures thoracic impedance (a resistive or reactive impedance associated with at least a portion of a thorax of a living organism). The thoracic impedance signal is influenced by the patient's thoracic intravascular fluid tension, heart beat, and breathing (also referred to as “respiration” or “ventilation. Higher frequency components of the thoracic impedance signal are influenced by the patient's breathing (e.g., approximately between 0.05 Hz and 2.0 Hz inclusive) and heartbeat (e.g., approximately between 0.5 Hz and 10 Hz inclusive). A low intravascular fluid tension in the thorax (“thoracic hypotension”) may result from changes in posture. For example, in a person who has been in a recumbent position for some time, approximately ⅓ of the blood volume is in the thorax. When that person then sits upright, approximately ⅓ of the blood that was in the thorax migrates to the lower body. This increases thoracic impedance. Approximately 90% of this fluid shift takes place within 2 to 3 minutes after the person sits upright. Also, the magnitude of impedance change is likely to be much greater for congestive changes than for normal respiratory variation. Thus, the system can detect congestive heart failure (CHF) in early stages and alert a patient to prevent disabling and even lethal episodes of CHF. Early treatment can avert progression of the disorder to a dangerous stage. (see para [0300, 0301]).
Therefore, it would have been obvious to one skill in the art to recognize that the alert a patient and notifying a nurse for assisting or suggesting to change his/her position to upright position, which will lower the patient’s thoracic intravascular fluid tension and breathing, to avoid of dangerous.
Response to Arguments
Applicant's arguments filed on 06/09/2026 have been fully considered but they are not persuasive. Because,
Applicant’s arguments:
(A) Nowhere does Tran mention pressure ulcer, which is defined in the specification as " localized injuries to the skin and/or underlying tissue, typically over bony prominences." Specification, paragraph [0004]. "They are caused by prolonged focused pressure, shear, or friction, and are commonly observed in patients with limited mobility, such as those confined to beds or wheelchairs."
(B) Such sensors have nothing to do with pressure sensors "configured to detect pressure applied to the object during the training scenario and to output sensor data reflecting the applied pressure."
(C) Claim 16 recites "performing the palpation training by applying pressure to
the object at a location corresponding to the sensor array and causing the sensor array to transmit sensor data to the computing device or the cloud-based platform", which is readily distinguishable from "the patient or person training with the EMG/EGK/EEG sensors" in Tran.
Response to the arguments:
(A) Tran et al teaches that the BI sensor can be used in a variety of clinical applications such as to estimate body composition, to measure blood flow, dehydration, blood loss, wound “or injury” monitoring, ulcer detection and deep vein thrombosis (see para [0288]). The system determines healing wounds “or injuries” if the impedance and reactance of the wound “or injury” region increases as the skin region becomes dry (see para [0302]). It is obvious to one skill in the art to recognize that the BI sensor and ulcer detector can be applied onto person’s body, skin or tissue to measure wound or injury, which is equivalent to the claim pressure ulcer as defined in applicant Specification, paragraph [0004]
(B) As the pressure ulcer sensor or BI sensor indicated in (A) above, and furthermore in paragraph [2012] In yet a further embodiment for performing motor motion analysis, an HMM is used to determine the physical activities of a patient, to monitor overall activity levels and assess compliance with a prescribed exercise regimen and/or efficacy of a treatment program. A physician, clinician, or physical therapist with access to patient data may remotely monitor compliance with the prescribed program or a standardized test on motor skill. For example, patients can take the Wolf Motor Function test and acceleration data is captured on the following tasks:
[0213] placing the forearm on a table from the side
[0214] moving the forearm from the table to a box on the table from the side
[0215] extending the elbow to the side
[0216] extending the elbow to the side against a light weight
[0217] placing the hand on a table from the front
[0218] moving the hand from table to box
[0219] flexing the elbow to retrieve a light weight
[0220] lifting a can of water
[0221] lifting a pencil, lifting a paper clip
[0222] stacking checkers, flipping cards
[0223] turning a key in a lock
[0224] folding a towel
[0225] lifting a basket from the table to a shelf above the table.
Therefore, it would have been obvious to one skill in the art to recognize that the physical therapist is working as a trainer to monitor overall activity levels, exercise regiment, test as a training session to train a patient by the Wolf Motor Function test and acceleration data.
(C) As the pressure ulcer cited in respect to claim 6 and in section (A) above, and including the claim performance of palpation reads upon the pressure sensing by electrode stimulation TENS device, light nanosensor, ulcer detection and deep vein thrombosis or any other suitable device, see Figs. 1, 2, 5A-5F, para [0087, 0172, 0288, 0305]).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/VAN T TRIEU/
Primary Examiner, Art Unit 2685
06/19/2026
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