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 § 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(s) 1, 3, 5, 6, 11, 18, 19, 41-43, 46, 47, 49-51, 53-55, 61, 63, 65-71 are rejected under 35 U.S.C. 103 as being unpatentable over Pederen et al [US 2018/0077502]
Consider claims 1. (Currently amended) A system to detect a man-down situation (MDS) of a person (the person/man 4 down or has fallen, see Fig. 1a, para [0079]), the system comprising: an earpiece (the hearing aid device 2 in an active ear-protection device, see Fig. 1, para [0019, 0144]) configured to provide hearing protection comprising an inertial measurement unit (IMU), the IMU capturing data about acceleration and rotation speed of the earpiece and comprising a digital gyroscope (the physical active measured movement by the accelerometer and A/D gyroscope 8, see Figs. 1, 10b, para [0029, 0039, 0144, 0273, 0289, 0290]);
a MDS detector (the person/man 4 down in data communication with the IMU, the MDS detector being configured to: segment the acceleration data and the rotation data captured by the IMU into time windows (the person/user’s handheld device 40 or an auxiliary device including an accelerometer, gyroscope and/or GPS to wirelessly communicate with the hearing aid device and to compare the acceleration patterns data there between, see Figs. 1, 10a, para [0079, 0085, 0092, 0154, 0232-0234]);
characterize statistical distribution models of extreme values in the segmented data (reads upon the hearing aid user faces dangerous situations including in the measured activity may also be further labelled, e.g. situations where the user 4′ is laying down, running or driving in a car may automatically be detected by the accelerometer and/or a gyroscope built-in to the hearing aid device 2 and be used as specific inputs for the hearing aid settings adjustment, see para [0162, 0098]);
based on the characterized statistical distribution models, discriminate between intended motions of the person and a fall of the person (the different or discriminate between the person/user 4 or 4’ is laying down, falling down, running or driving in a car situations (see Figs. 2b, 2c, para [0159, 0162]); and
identifying a MDS when detecting occurrences of at least two critical states during in temporal sequence over a predefined period detect the MDS based on the captured data of the IMU (as cited above, wherein the measured a person/user 4 fallen situations that the hearing aid device comprises means for changing the settings with a predefined speed over time 14 based on the different input, including the level of physical activity detected by means of the hearing aid device, such as when free fall is detected, change sample rate from 30 times per second to 1000 times per second and change resolution from +/−2 g to +/−16 g. One possible criterion to determine that the hearing aid device 2 is dropped may be the detection of an acceleration corresponding to the acceleration of the force of gravity for a predefined time period e.g., a time period corresponding to that the hearing aid device 2 is moved more than 50 cm, e.g. more than 100 cm downwards in the vertical direction (this depends on the initial speed of the hearing aid device 2)., see Figs. 1c, 1e, 9, 11a, 11b, para [0043, 0075, 0147, 0157, 0232, 0266-0273]). But
Pederen et al fails to disclose determine a combination of at least two critical states amongst at least a fall state (F), an immobility state (I), and a down position state (D). However, Pederen et al teaches that the in particular for elderly people, is related to accentual falls, e.g. in unattended situations, e.g. at home. The reason for the fall can be several, however the problem is the same. If a person is not able to move after the fall has occurred, the person may not be able to call for help or not able to operate this device either”, see para [0079]). The alarm is triggered by a free fall and/or a hard landing, see para [0243]).
Therefore, it would have been obvious to one skill in the art to recognize that the people or user accentual free fall and hard landing causes unable to call or to operate the device indicates as the claim of two critical states amongst at least a fall state, because the unable to call or operate by a fall person/user is showing of an immobility condition and serious fall.
Claim 2. (Cancelled)
Consider claim 3. (Previously presented) The system of claim 1, the IMU further comprising a digital accelerometer measuring acceleration about 3-axis (the x, y, z axis, see Fig. 11a, para [0031, 0288-0290]).
Claim 4. (Canceled)
Consider claim 5. (Previously presented) The system of claim 3, the measured acceleration being linear acceleration measurements (see Figs. 12b, 12c, para [0018, 0029, 0144, 0293]).
Consider claim 6. (Currently amended) The system of claim 65, the rotational speed measurements being cep we VE if om [os wy ty (reads upon the second way of estimating the angular velocity ω is based on integration of the linear acceleration a.sub.x orthogonal to the radius of the movement as illustrated in FIG. 12a. Angular velocity is defined as
d.Math.Math.ωdt=axr, where r is me radius either determined physically or estimated. Solving for ω gives: ω=1r.Math.∫0t.Math.ax(t).Math.dt,.Math., (see Figs. 11a, 12a, para [0293-0298]).
Claims 7-10. (Cancelled)
Consider claim 11. (Currently amended) The system of claim 1, the system combination of the two detected critical states as combinatorial states, comprising: a combinatorial state F-I being a wearer of the system having fell and remaining inert regardless of the position of the wearer (as cited in respect to claim 1 above, such as the person/user not able to move after the fall has occurred, the person may not be able to call for help or not able to operate this device either “as immobility situation”, see para [0079]);
a combinatorial state F-D being a wearer having fell and remaining lying down on the ground thereafter; and a combinatorial state I-D being the inert wearer lying down on the ground (as cited in respect to claim 1 above, such as the person/user activity situations of person/user 4’ is laying down, see para [0162]).
Claims 12-17. (Cancelled)
Consider claim 18. (Original) The system of claim 1, the system comprising a second earpiece comprising IMU, the IMU capturing data about acceleration and rotation speed of the second earpiece (as cited in respect to claim 1 above, and including two hearing aid devices 2, see Figs. 3b, 12b, 12c, abstract, para [0025, 0056]).
Consider claim 19. (Currently amended) The system of claim 18, the MDS detector being further configured to capture inertial measurement from the second earpiece for the detection of the fall (F), immobility (I) and down on the ground (D) states (as cited in respect to claim 18 above, and the yaw is defined as a rotation of the head around the y-axis. Can be measured by either a single or a pair of hearing aid devices. see Figs. 12a, para [0288, 0291]).
Claims 20-40. (Cancelled)
Consider claim 41. (Currently amended) A man-down detection system, comprising: an earpiece providing hearing protection for an ear of a user comprising one or more sensors configured to capture data about acceleration and rotation speed of the earpiece, a processing unit in data communication with the one or more sensors configured to: segment the acceleration data and the rotation data captured by the sensors into time windows; characterize statistical distribution models of extreme values in the segmented data; based on the characterized statistical distribution models, discriminate between intended motions of the person and a fall of the person; determining a combination of at least two critical states amongst at least a fall state (F), an immobility state (I), and a down position state (D); and compute detection probabilities of occurrences of a man-down situation (MDS) which comprises at least two critical states during in temporal sequence over a predefined period of time (as cited in respect to claim 1 above, and including the detection probability, (see Fig. 10b, para [0075, 0239, 0240, 0274]).
Consider claim 42. (Currently amended) The system of claim 41, the system being further configured to generate a man-down alert when the man down situation is detected (as cited in respect to claim 41 above, and including the automatic alarm/alert, see para [0069, 0079, 0234-0237, 0241-0248]).
Consider claim 43. (Currently amended) The system of claim 41 comprising two earpieces to be worn in both ears of the user, the processor unit being in data communication with the one or more sensors of the two earpieces (as cited in respect to claim 19 above), the processor unit being configured to detected the MDS when the computed detection probabilities of occurrences of the MDS is over a predetermined threshold in the two earpieces (the probability, see Fig. 10b, para [0075, 0239, 0240, 0274]), and the predetermined threshold, see Fig. 1b, para [0144]).
Claims 44, 45. (Cancelled)
Consider claim 46. (Currently amended) The system of claim 41, the sensors being configured to capture data about comprising measuring heart rate, respiration rate, blood oxygenation, or combinations thereof (as cited in respect to claims 1 and 41 above, and including heart rate changes and blood flow, see para [0097, 0106]).
Consider claim 47. (Currently amended) The system of claim 41, wherein one or more sensors includes: an inertial measurement unit (IMU) configured to capture data of the acceleration and rotation speed of the earpiece (as cited in respect to claims 18, 19 above).
Claim 48. (Cancelled)
Consider claim 49. (Currently amended) The system of claim 41, the processor unit being further configured to perform a recalibration to adjust at least one of a predefined threshold angle, a specified time interval of the user remaining motionless, a predefined threshold of the deviation of a physiological parameter (as cited in respect to claims 1, 11, 19, 46 above, and including another calibration, see Fig. 5b, para [0185]).
Consider claim 50. (Previously presented) The system of claim 49, the processing unit being further configured to perform the recalibration at predefined time intervals (the measurement during another calibration routine of the hearing aid device 2, see Fig. 10b, para [0185, 0264]).
Consider claim 51. (Previously presented) The system of claim 49, the processing unit being further configured to perform the recalibration upon detection of anomalous sensor data (reads upon the another calibration during fitting when both hearing aid device 2 is not reliable cue, see Fig. 5b, para [0185]).
Claim 52. (Cancelled)
Consider claim 53. (Currently amended) A method of detecting a man-down situation (MDS) comprising: receiving acceleration data and the rotation orientation data from a sensor of an earpiece worn in an ear of a user; segmenting the acceleration data and the rotation data captured by the sensors into time windows; characterizing statistical distribution models of extreme values in the segmented data; based on the characterized statistical distribution models, discriminating between intended motions of the person and a fall of the person; determining a combination of at least two critical states amongst at least a fall state (F), an immobility state (1), and a down position state (D); and identifying a MDS when at least two critical states during in temporal sequence over a predefined period of time have been determined (as cited in respect to the apparatus claim 1 above).
Consider claim 54. (Currently amended) The method of claim 53 further comprising generating a man-down alert when the computed detection probabilities are over a predetermined threshold (reads upon estimating Shock Level as the shock levels can be very high, it can be too high for the accelerometer to measure. Also the impact will have a very short duration of time (hence, when a free fall is being detected, the sample rate and the measurement range of the accelerometer should preferably be maximized in order to increase the probability of recording the impact). Instead, the accelerometer could estimate the drop height by measuring free fall time and from that estimate the shock level, further the accelerometer data could possible identify the surface hardness for use in the estimation, see para [0273]), wherein the large linear and angular accelerations and velocities indicate a high, low or moderate activity threshold values to define in advance of operation of the hearing aid device 2, see para [0144]).
Consider claim 55. (Currently amended) The method of claim 53, wherein the acceleration data; the rotation data are received by sensors of two earpieces, the MDS being detected when the detection probabilities are computed in the two earpieces (as cited in respect to claims 19, 43 above).
Claims 56-58. (Cancelled)
Consider claim 61. (Previously presented) The method of claim 59, the adjustment of the thresholds being performed upon detection of anomalous sensor data (the adjustment or change of specified of position upon detected of user’s eye gaze or user’s head angular position by the accelerometer or gyroscope sensors, see para [0218]).
Claim 62. (Cancelled)
Consider claim 63. (Currently amended) The method of claim 53 further comprising analyzing extreme values of an average of acceleration norms, average of rotational speed norms and average of tilt angle derivatives (the user’s current average physical activity including motions, position, rotation and/or angular velocity parameters derivative with respect to time, see Figs. 2a, 11, para [0018, 0152, 0289-0292, 0297]).
Claim 64. (Cancelled)
Consider claim 65. (New) The system of claim 1, the digital gyroscope measuring rotational speed about 3-axis, the IMU being configured to correct the rotational speed measurements by evaluating average rotational speed offset while the gyroscope is stationary (as cited in respect to claims 1, 3 and 63 above, see Fig. 11a).
Consider claim 66. (New) The system of claim 41, the processing unit being further configured to extract acceleration norms, rotational speed norms and tilt angle derivatives from the segmented data, the characterization of the statistical distribution models using the extracted acceleration norms, rotational speed norms and tilt angle derivatives (as cited in respect to claims 1, 6 and 63 above, and including rotated or tilted hearing aid device 2, see Figs. 5b, 11a, 11b).
Consider claim 67. (New) The system of claim 41, the processing unit being further configured to compare the characterized models to a pre-trained database comprising inertial data records of fall profiles, to discriminate between intended motions and a fall event (as cited in respect to claims 1, 41 above, and including comparing data with stored reference position, see Figs. 1e, 4, 9b, para [0062, 0068, 0084, 0147, 0219]).
Consider claim 68. (New) The system of claim 41, the processing unit being further configured to fuse the detection probabilities to detect the MDS only when at least two of the critical states occur in temporal sequence over a predefined period (see Fig. 10b, para [0274]).
Consider claim 69. (New) The system of claim 68, the fusing achieving a false positive rate below 1.1% while maintaining at least 99% detection accuracy (read upon it may be an advantage that the hearing aid device contains both an accelerometer and a gyroscope so that both linear and rotational movement of the head of the user or of the hearing aid can be determined with high precision and higher accuracy (see para [0030, 0297]). And the detected of free fall sample rate, see Fig. 10b, para [0075, 0274]).
Consider claim 70. (New) The system of claim 41, the system comprising a second earpiece comprising sensors capturing data about acceleration and rotation speed of the second earpiece (as cited in respect to claims 18, 19 above).
Consider claim 71. (New) The system of claim 70, the processing unit being further configured to calculate rotation movement of the head of the user as a consequence of a fall (the detect all impacts levels, time and numbers to the hearing aid for improved reliability data. Log impact sequence to analyze displacements of receiver/suspension to improve design. Detect all free falls including pitch, yaw and angles of rotation, fall time, aids direction on impact and numbers to the hearing aid for design and reliability improvements, see Figs. 10b, 11a, para [0269-0273, 0287-0291]).
Claims 59, 60 are rejected under 35 U.S.C. 103 as being unpatentable over Pederen et al [US 2018/0077502] in view of Parshionikar [US 2020/0249752]
Consider claim 59. Pederen et al fails to disclose determining whether the received orientation data exceeds a predefined angle threshold over a predetermined period; and adjusting at least one of the predefined threshold angle, the specified time interval of the user remaining motionless. However, Pederen et al discloses the hearing aid device 2 2 comprises a sensor member 8 that is configured to detect motion of the hearing aid device 2 and thus the level of physical activity of the hearing aid user 4. The sensor member 8 comprises an accelerometer or a gyroscope or both. By means of the accelerometer and/or gyroscope the hearing aid device 2 is capable of determining the level of physical activity of the hearing aid user 4. The duration as well as the intensity of activities of the hearing aid user 4 may be determined by means of the sensor member 8 by logging measured data over time. Large linear and angular accelerations and velocities indicate a high level of activity, while low or moderate linear and angular accelerations and velocities indicate a moderate or low level of activity threshold values between large and medium (and e.g. low) for each parameter being e.g. defined in advance of operation of the hearing aid device (see Fig. 1b, para [0144]).
Parshionikar suggests that the user gestures can be used with head worn devices including ear phones, ear buds with inertial orientation sensors such as accelerometers and gyroscopes, see Fig. 1, 22, 23, Tables 6, 7, para [0119, 0120, 0169, 0171, 0181]).
The user is looking at can be monitored against a specified threshold of position change, to determine if a period of No Motion is being encountered with user's eye gaze. The Periods of Limited Activity “POLA” may be defined as the time period when user's head is rotating angular between 30 degrees/sec to 40 degrees/sec in Yaw whereas a period of No Motion may be defined as when the user's head is rotating at less than +/−5 degrees/second. Therefore, it can be seen that periods of No Motion can be POLAs but not all POLAs are periods of No Motion (see Fig. 1, para [0218, 0219, 0538]).
Therefore, it would have been obvious to one skill in the art before the effective filed date of the invention to add or implement the monitoring of user gestures orientation threshold of position angle being adjusted/changed of the periods of no-motion or motionless of Parshionikar to the hearing aid device of Pederen et al for providing a higher accuracy results indicating a person/user fall states or fall situations, since the analogous art is not limit to references in the field of endeavor of the person or user wearing an ear phone, ear bud or hearing aid device built with accelerometer and gyroscope sensors for monitoring and determining if the worn person falling states, that is useful for the invention’s purpose.
Consider claim 60. Pederen et al fails to disclose the adjustment of the thresholds being performed at predefined time intervals (as the combination between Pederen et al and Parshionikar in respect to claim 59 above, and including the change in location or the point (the user is looking at) can be monitored against a specified threshold of position change (see Parshionikar, para [0218]).
Response to Arguments
Applicant’s arguments with respect to claims 1, 41 and 53 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments:
(A) Applicant submits that the new amended independent claims 1, 41 and 53 are inventive over Takahashi in view of Hernandez et al and comply with 35 U.S.C. 103.
Response to the arguments:
(A) Based upon the new amended independent claims 1, 41 and 53, a new reference of Pederen et al is introduce to make the rejections smoother. Dependent claims 59 and 60 are obviously to combine with a reference of Parshionikar since both references are in the field of endeavor of the person or user wearing an ear phone, ear bud or hearing aid device built with accelerometer and gyroscope sensors for monitoring and determining if the worn person falling states, that is useful for the invention’s purpose.
Conclusion
Any inquiry concerning this communication or earlier communications from examiner should be directed to primary examiner craft is Van Trieu whose telephone number is (571) 2722972. The examiner can normally be reached on Mon-Fri from 8:00 AM to 3:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Mr. Kuntz Curtis can be reached on (571) 272-7499.
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/VAN T TRIEU/
Primary Examiner, Art Unit 2687
11/11/2025