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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: No. 190. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Paragraph 18, Line 2: The word “sensors” should be singular to agree with the phrase –at least one--.
Paragraph 19, Line 2: The word “a” before “textile-based products” should be deleted.
Paragraph 22, Line 3: The word “a” before “thin,” is not needed to agree with the plural “sensors”.
Paragraph 32, Line 6: The verb “drive” should be changed to –driven--.
Paragraph 37, Line 6: The pump is numbered –185—elsewhere in the specification and in the drawings.
Appropriate correction is required.
Claim Objections
Claims 8 and 22 are objected to because of the following informalities: The word –photoplethysmography—has been misspelled in these two claims. 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 –
(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 1-3, 5, 7, 10, 12, 15, 16, 19, 20-22, 26, 27, and 30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mix et al [US 2014/0039351].
For claim 1, the device for mitigating fall-related injuries (Figs. 9; Paragraph 187: a fall prevention control 120) taught by Mix includes the following claimed subject matter, as noted, 1) the claimed textile substrate is met by the flexible mat (No. 32) configured to abut a body of a living being (Paragraph 140: similar to a conventional fitted sheet that can be placed over a mattress), 2) the claimed at least one sensor is met by the sensor array (No. 22) supported on said textile substrate in a position to register with an intended portion of the body (Paragraph 151: configured to take readings from those sensor cells 110 near the torso of the patient) and operable to capture biometric-related data (Paragraph 23: a patient’s heart rate, a patient’s breathing rate, a patient’s temperature, a patient’s height, a patient body mass index) usable to predict walking movement (Paragraph 170: Sensor array 22 may also be used to issue a bed exit alert), 3) the claimed control module is met by the controller (No. 24) having a sensor controller (No. 28) operable to 4) receive data from said at least one sensor (Paragraph 151: sensor controller 28 will take measurements from each sensor cell 110), 5) determine whether walking movement of the body is imminent as a function of data received from said at least one sensor (Paragraph 159: the sensing is performed by performing one or more algorithms on the pressure data that is gathered from sensor cells; Paragraph 171: In another embodiment, an alert may be issued while the patient is still on patient support 36, but the pressure has changed in such a manner as to indicate that a bed exit action by the patient may be likely), and 6) transmit a control signal if it is determined that walking movement of the body is imminent (Paragraph 171: A bed exit alert may therefore be issued prior to the patient actually exiting the patient support), and 7) the claimed intervention device is met by the tablet (No. 44) having the user interface controller (No. 30) having both wired and wireless communication (Paragraph 116) and operable to provide an intervention responsive to receipt of the control signal (Paragraph 135: If sensing system 20 detects a condition that gives rise to an alert, tablet 44 may communicate this information to network 74…where tablet server 86 may pick up this information and forward it to mobile communication server 88 for wireless forwarding to the appropriate personnel).
For claim 2, the flexible mat (No. 32) of Mix is integrated as a covering of an item of furniture (Paragraph 141: flexible mat 32 is adapted to be releasably coupled to a mattress, or other type of support surface).
For claim 3, the sensor arrays (No. 22) of Mix may be incorporated into fabric that is worn by the patient (Paragraph 230).
For claim 5, the Mix device gathers data related to bodily movement (Paragraph 49: patient movement), heart rate and body temperature (Paragraph 23), and respiratory rate (Paragraph 210: breathing rate).
For claim 7, the controller of Mix may determine a location of the patient’s torso on the sensor array and use the knowledge of the location of the patient’s torso when determining the heart rate of the patient (Paragraph 30).
For claim 10, one of the sensors in the flexible mat of Mix may be an accelerometer (Paragraph 175).
For claim 12, the system of Mix receives movement data from the sensor array (No. 22) to determine whether the body is walking (Paragraph 171: an alert might be issued only when sensor array 22 ceases to detect any patient pressure).
For claim 15, the alert of Mix may be a speaker operable to produce audible feedback in response to receipt of the control signal (Paragraph 176: As with any of the alerts that may be issued by sensing system 20, the alert may be local (audio or visual or both)).
For claim 16, the intervention device of Mix may be a remote computing device operable to provide a notification message in response to receipt of the control signal (Paragraph 135: If sensing system 20 detects a condition that gives rise to an alert, tablet 44 may communicate this information to network 44…and forward it to mobile communication server 88 for wireless forwarding to the appropriate personnel).
For claim 19, the device for mitigating fall-related injuries (Figs. 9; Paragraph 187: a fall prevention control 120) taught by Mix includes the following claimed subject matter, as noted, 1) the claimed bedding structure is met by the flexible mat (No. 32) configured to overlie a mattress (Paragraph 140: similar to a conventional fitted sheet that can be placed over a mattress) to support a body of a living being, 2) the claimed at least one sensor is met by the sensor array (No. 22) supported on said textile substrate in a position to register with an intended portion of the body (Paragraph 151: configured to take readings from those sensor cells 110 near the torso of the patient) and operable to capture biometric-related data (Paragraph 23: a patient’s heart rate, a patient’s breathing rate, a patient’s temperature, a patient’s height, a patient body mass index) usable to predict walking movement (Paragraph 170: Sensor array 22 may also be used to issue a bed exit alert), 3) the claimed control module is met by the controller (No. 24) having a sensor controller (No. 28) operable to 4) receive data from said at least one sensor (Paragraph 151: sensor controller 28 will take measurements from each sensor cell 110), 5) determine whether walking movement of the body is imminent as a function of data received from said at least one sensor (Paragraph 159: the sensing is performed by performing one or more algorithms on the pressure data that is gathered from sensor cells; Paragraph 171: In another embodiment, an alert may be issued while the patient is still on patient support 36, but the pressure has changed in such a manner as to indicate that a bed exit action by the patient may be likely), and 6) transmit a control signal if it is determined that walking movement of the body is imminent (Paragraph 171: A bed exit alert may therefore be issued prior to the patient actually exiting the patient support), and 7) the claimed intervention device is met by the tablet (No. 44) having the user interface controller (No. 30) having both wired and wireless communication (Paragraph 116) and operable to provide an intervention responsive to receipt of the control signal (Paragraph 135: If sensing system 20 detects a condition that gives rise to an alert, tablet 44 may communicate this information to network 74…where tablet server 86 may pick up this information and forward it to mobile communication server 88 for wireless forwarding to the appropriate personnel).
For claim 20, the bedding structure of Mix comprises at least a fitted sheet (Paragraph 140: characteristics similar to a conventional fitted sheet).
For claim 21, the Mix device gathers data related to bodily movement (Paragraph 49: patient movement), heart rate and body temperature (Paragraph 23), and respiratory rate (Paragraph 210: breathing rate).
For claim 22, the sensors taught by Mix may include at least a temperature sensor, heart rate sensor, and accelerometer (Paragraph 23).
For claim 26, the alert of Mix may be a speaker operable to produce audible feedback in response to receipt of the control signal (Paragraph 176: As with any of the alerts that may be issued by sensing system 20, the alert may be local (audio or visual or both)).
For claim 27, the intervention device of Mix may be a remote computing device operable to provide a notification message in response to receipt of the control signal (Paragraph 135: If sensing system 20 detects a condition that gives rise to an alert, tablet 44 may communicate this information to network 44…and forward it to mobile communication server 88 for wireless forwarding to the appropriate personnel).
Claim 30 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Halperin et al [US 2013/0267791].
For claim 30, the device for mitigating fall-related injuries (Paragraph 618: prevent a potential fall by the recipient) taught by Halperin includes the following claimed subject matter, as noted, 1) the claimed wearable consumer electronics device is met by the fitness watch (Paragraph 635: system 10 may interface with a fitness watch) to be worn on a body of a living being, 2) the claimed at least one sensor is met by the sensors (Nos. 30 and 60) supported on the wearable consumer electronics device (Paragraph 435: motion sensor 30 does contact the body of patient 12 or clothes patient 12 is wearing) in a position to register with an intended portion of the body and operable to capture biometric-related data (Paragraph 437: blood oxygen monitor, ECG monitor, weight sensor, temperature sensor) useable to predict walking movement (Paragraph 479: System 10 detects a likelihood of imminent bed exit), 3) the claimed control module is met by the control unit (No. 14) operable to 4) receive data from said at least one sensor (see Fig. 2, sensors input to pattern analysis module No.16), 5) determine whether walking movement is imminent as a function of data received from said at least one sensor (Paragraph 479: system 10 may have a plurality of sensitivity levels for detecting the patient exiting the bed), and 6) transmit a control signal if it is determined that walking movement of the body is imminent (Paragraph 479: if one or more of the above listed criteria is true the system alerts the clinician that the probability of a bed exit is high), and 7) the claimed intervention device is met by the central monitoring system connected to the control module and operable to provide an intervention responsive to receipt of the control signal (Paragraph 537: For example, if the patient is trying to get out of bed without assistance when he is not supposed to, or if the patient has a significant change in heart rate or respiratory rate, system 10 communicates the nature of the alert to the central monitoring system which present that information to the relevant nurse or physician).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Mix et al.
For claim 4, the Mix reference does not specifically mention a hospital gown, robe, kimono, tank top, pants, leggings or undergarments. However, as noted above in the rejection of claim 3, the sensor array of Mix may be incorporated into fabric that is then worn by the patient. Furthermore, the Mix reference is meant to be used in a hospital setting. Hospital gowns are worn by nearly every in-patient and some out-patients and is one obvious garment to incorporate the sensor array of Mix because of its ubiquity in hospitals and clinics. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to install the sensor array of Mix into a hospital gown for the purpose of using a common and well-known garment that is already present in every hospital and will be worn by any patient.
Claims 6, 13, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Mix et al in view of Kantorovich [US 2007/0123778].
For claim 6, there is no mention of an ultrasound sensor in the sensory array of Mix to overlie at least one of a bowel structure or urinary bladder structure of the body.
Sensors have been used in the past to determine the state of bladder size in the body. Furthermore, the measuring device taught by Kantorovich uses ultrasonic frequencies (Paragraph 36) sent into the body of a patient to determine the distance between walls of the bladder (Fig. 1A). Moreover, the system even includes an alarm unit (No. 690) once the bladder becomes greater than a percentage to notify the user or caretaker to take action (Paragraph 215).
The Kantorovich reference presents another possible situation where walking is imminent; that is, having to walk to the bathroom for evacuation. And this situation can happen frequently in a hospital, as the patient would necessarily have to exit the bed to urinate. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an ultrasound or ultrasonic sensor in the sensor array of Mix for the purpose of detecting one obvious reason why someone would have to exit a bed to walk to the bathroom, said action may result in a fall that has to be prevented.
For claim 13, the biometric data gathered by Kantorovich determines whether bladder contents volume is imminent. The combination of this with the Mix reference would result in another reason why a patient would exit a bed and walk to a bathroom.
For claim 24, the biometric data gathered by Kantorovich determines whether bladder contents volume is imminent. The combination of this with the Mix reference would result in another reason why a patient would exit a bed and walk to a bathroom.
Claim 8, 11, 14, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Mix et al in view of Halperin et al.
For claim 8, there is no mention of a photoplethysmography sensor in the system taught by Mix.
The sensors such as heart rate, temperature, and respiration found in Mix are not the only sensors that are available to a user of the system. The Halperin reference includes a plurality of sensors (No. 60) that can sense or detect a number of different variables, including a moisture sensor (No. 85), temperature sensor (No. 80), and a blood oxygen monitor (No. 86), which may be a pulse oximeter or photoplethysmography sensor.
The Halperin reference performs very similar functions as the Mix reference. Both are capable of gathering biometric data in order to predict walking or at least an exit from a bed. And the Halperin reference shows that photoplethysmography may be used as one possible biometric variable in a patient. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the blood oxygen monitor of Halperin into the sensors of Mix for the purpose of detecting a useful value to determine the patient’s condition and well-being.
For claim 11, the Halperin reference uses accelerometers that may overlie a long of a patient’s body (Paragraph 491: this is implemented via an accelerometer worn on the patient’s body, e.g., on the patient’s chest).
For claim 14, the control module (No. 14) of Halperin receives biometric data such as heart rate indicating that walking movement is likely imminent (Paragraph 479: For example, if the patient shows a higher level of restlessness or an increase in heart rate, or a combination of the two, this may be interpreted by the system as indicating that the patient is becoming less restful and the nurse may need to be called as the patient may be close to trying to get out of bed).
For claim 25, the control module (No. 14) of Halperin receives biometric data such as heart rate indicating that walking movement is likely imminent (Paragraph 479: For example, if the patient shows a higher level of restlessness or an increase in heart rate, or a combination of the two, this may be interpreted by the system as indicating that the patient is becoming less restful and the nurse may need to be called as the patient may be close to trying to get out of bed).
Claims 9, 17, 18, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Mix et al in view of Coffey et al [US 2023/0000396].
For claim 9, the Mix reference does mention a temperature sensor. However, it does not mention a thermocouple or a digital thermometer sensor.
The prior art has used thermocouples to detect the temperature of a patient, and they have been used at least as long as the filing date of the current application. The system for detecting movement taught by Coffey relates generally to systems and methods for predicting and preventing impending falls of a resident of a facility such as a hospital (Paragraph 2). Like the Mix reference the system uses a plurality of sensors (No. 250), including a motion sensor (No. 253), a photoplethysmography sensor (No. 261), and a temperature sensor (No. 252). The temperature sensor can be a thermocouple sensor (Paragraph 37). Also, the Coffey reference also detects when a resident attempts to exit a bed (Paragraph 181).
The Coffey reference presents plain evidence that thermocouples have not only been used to measure temperature, they have also been used to determine if a patient is attempting to exit a bed to walk. And the Mix reference also measures temperature as part of its biometric measurements. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a thermocouple such as that found in Coffey in the system of Mix for the purpose of using a proven temperature sensor that can also assist in measuring a patient’s condition.
For claim 17, Figures 6 and 7 of Coffey illustrate an effect of the control system when a patient is positioned near the edge of the bed. Moveable barriers (Nos. 351-354) are raised and lowered depending on which side of the bed the patient is positioned.
For claim 18, as some type of motorized apparatus is needed to move the moveable barriers in the positions between Figures 6 and 7 of Coffey, this is considered one obvious method to move said barriers. Furthermore, the Coffey reference details (Paragraph 67) other actuatable devices that are used in conjunction with the bed, such as inflatable pillow or mattress regions or in conjunction with other devices (e.g., walls, floor, sofas, and railings).
For claim 28, Figures 6 and 7 of Coffey illustrate an effect of the control system when a patient is positioned near the edge of the bed. Moveable barriers (Nos. 351-354) are raised and lowered depending on which side of the bed the patient is positioned.
For claim 29, as some type of motorized apparatus is needed to move the moveable barriers in the positions between Figures 6 and 7 of Coffey, this is considered one obvious method to move said barriers. Furthermore, the Coffey reference details (Paragraph 67) other actuatable devices that are used in conjunction with the bed, such as inflatable pillow or mattress regions or in conjunction with other devices (e.g., walls, floor, sofas, and railings).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Mix et al in view of Proud [U.S. 9,149,189].
For claim 23, the sensor array (No. 22) of Mix does detect movement in that different pressures are indicative of the position of the patient on the mattress, including using accelerometers. However, this data is not used to determine whether the body is in the process of walking.
Patient observation systems need not be confined to a bed or in one location. The patient monitoring method taught by Proud uses telemetry data on user habit information or user monitoring. One or more sensors (No. 14) detects user information selected from a user’s activities, behaviors, and health. The system also includes a method (Fig. 21) for providing alerts if signals reach a certain threshold. One important aspect of the Proud reference is that the sensors can be embedded in clothing or shoes (Col. 18, Lns. 64-67) that enables the system to monitor various functions while the user is walking.
The obvious advantage of the Proud reference is that it does not require the patient to be near a bed or piece of furniture in order to function. This frees the patient to move around while still being monitored by the system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the sensing fabric of Mix into clothing to detect walking for the purpose of providing some sense of freedom and autonomy to the patient.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bartlett et al [U.S. 5,611,096] adjusts pressures of a therapeutic mattress.
Benditt et al [US 2005/0267381] uses photoplethysmography to detect flow change.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A. TWEEL JR whose telephone number is (571)272-2969. The examiner can normally be reached M-F 8-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Davetta W Goins can be reached at 571-272-2957. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JAT
11/5/2025
/JOHN A TWEEL JR/Primary Examiner, Art Unit 2689