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 .
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 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or no obviousness.
Claims 1-2, 9-13, and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al., (US 20160070245; hereinafter Lee) in view of Venkatraman et al., (US 20140275854; hereinafter Venkatraman), Colburn et al., (US 4353375; hereinafter Colburn), Loree, IV et al., (US 20120313773; hereinafter Loree), Sun et al., (US 20120203491; hereinafter Sun), and Thomson et al., (US 20150018660; hereinafter Thomson).
Regarding claims 1-2, Lee discloses (Figure 10) a wearable device (1000), ([0081]), [0106]) comprising: a strap configured to be worn over a wrist of a subject, the strap having an outer surface and an inner surface; a sensor (1011) on the inner surface configured to measure a physiologic parameter ([0106], [0107]); wherein the outer surface does not include any buttons or user-operated controls (there is no means for user input); a controller in the strap configured to trigger measuring of the physiologic parameter by the sensor (1011), ([0108]).
Lee fails to disclose an accelerometer configured to detect motion of the wearable device and transmit a signal to the controller when the motion is detected. However, Venkatraman teaches a wearable device for monitoring a patient, including an accelerometer configured to detect motion of the wearable device and transmit a signal to a controller when the motion is detected, ([0045]-[0046]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee to include an accelerometer configured to detect motion of the wearable device and transmit a signal to the controller when the motion is detected, as taught by Venkatraman, because the modification would provide motion detection to infer when the user is substantially active or stationary (Venkatraman, [0016]).
Lee/Venkatraman fails to teach that the controller includes an internal counter storing a counter value and is further configured to increment the counter value in accordance with the signal received from the accelerometer, record how many times the counter value incremented in a particular time period, determine the particular time period to be the low active time period based on how many times the counter value is incremented in the particular time period. However, Colburn teaches a wearable monitoring apparatus comprising a controller which includes an internal counter (18) storing a counter value and is further configured to. increment the counter value in accordance with an activity signal (12), record how many times the counter value incremented in a particular time period, and determine the particular time period to be the low active time period based on how many times the counter value incremented (Col. 2, line 46 – Col. 4, line 50). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee/Venkatraman to include an internal counter storing a counter value, wherein the controller is further configured to increment the counter value in accordance with the signal received from the accelerometer, record how many times the counter value incremented in a particular time period, determine the particular time period to be the low active time period based on how many times the counter value incremented, as taught by Colburn, because the modification would enable activity levels to be accurately recorded in a human patient over a number of time intervals (Colburn; Col. 1, lines 55-58) for a specific representation of patient activity level beyond just rest/motion. Furthermore, the modified device would use the signal received from the accelerometer as the activity signal.
Lee/Venkatraman/Colburn fails to teach that the controller is configured to set a state of the wearable device to a sleep state if the predetermined time period is determined to be neither the low active time period nor an inactive time period in which the counter value is not incremented in the particular period. However, Loree teaches a wearable device ([0009]: personal device) comprising a controller which is configured to set a state of the wearable device (personal device) to a sleep (monitoring mode) state during a time period other than a low active time period or an inactive time period ([0058]-[0059]: the system is in a monitoring/sleep state until the motion sensor relays that the user is inactive/asleep; therefore, the system is in a sleep state when it is neither in the low active time period nor an inactive time period). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee/Venkatraman/Colburn to include that the controller is configured to set a state of the wearable device to a sleep state during a time period other than the low active time period or an inactive time period, as taught by Loree, because the modification would ensure that the system is only active when the user is in a sleep/low active/inactive state (Loree; [0059]).
Lee/Venkatraman/Colburn/Loree fails to teach wherein a measurement of the physiologic parameter is less frequent in the sleep state than in the low active time period or the inactive time period. However, Sun (Figures 1 and 4B) teaches a wearable device, wherein a measurement of a physiologic parameter (ECG signal) is less frequent in a sleep state (active, e.g. walking state) than in a low active time period or the inactive time period (e.g. inactive/sitting or standing period), ([0034]-[0035], [0039]-[0040], [0056], [0063]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee/Venkatraman/Colburn/Loree to include a measurement of the physiologic parameter being less frequent in the sleep state than in the low active time period or the inactive time period, as taught by Sun, because the modification would boost sensor accuracy and optimize energy consumption (Sun; [0034]).
Lee/Venkatraman/Colburn/Loree/Sun fails to teach wherein the wearable device does not include any display. However, Thomson teaches a wearable device which may be configured without a display or output. Instead, the device may rely on communication with a base station such as a mobile telecommunications device to display and/or analyze the signal ([0121]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee/Venkatraman/Colburn/Loree/Sun such that the wearable device does not include any display, as taught by Thomson, because the modification may make the device less bulky, lighter, and less expensive to manufacture and operate (Thomson; [0121]).
Regarding claim 9, the modified device includes the teachings of Venkatraman, which teaches that the motion sensor is configured to transmit a signal to the controller when the motion of the apparatus is detected, and the controller is configured to count a number of signals received from the motion sensor in each of predetermined time periods and trigger the sensing and acquiring of the data only when the counted number of signals is incremented a particular number of times, the particular number being less than a threshold ([0038], [0046]: the motion sensor transmits signals when apparatus motion is detected, and the controller determines when the user is stationary/moving using these signals; the signals are thus used to trigger sensing/acquiring when the user is stationary when the number of signals falls below a threshold of any signals showing movement).
Regarding claim 10, the modified device includes the teachings of Venkatraman, which teaches that the signal is an interruption signal that awakens the controller that is in a sleep state (the signals of the motion sensor inform the controller if the user is stationary/moving; therefore, the signals awaken the controller with these signals).
Regarding claim 11, Lee further discloses (Figures 1 and 10) that the strap (100) has a plurality of holes arranged in a webbing pattern ([0106]-[0108]).
Regarding claims 12-13, Lee/Venkatraman/Colburn/Loree/Sun/Thomson teaches the apparatus of claim 1, but Lee/Colburn/Loree/Sun/Thomson fails to teach a plurality of diodes arranged along and embedded in the strap; and a plurality of pipes connected to the respective diodes in the strap and through which lights are emitted from the diodes toward an outside of the apparatus. However, Venkatraman teaches a wrist-worn heart monitor apparatus for monitoring a patient, including a plurality of diodes (LEDs) arranged along and embedded in the strap; and a plurality of pipes connected to the respective diodes in the strap and through which lights are emitted from the diodes toward an outside of the apparatus ([0124]: pipes carrying lights for emission from the diodes toward the outside are required for the LEDs to function as light sources). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee/Colburn/Loree/Sun/Thomson to include a plurality of diodes arranged along and embedded in the strap, and a plurality of pipes connected to the respective diodes in the strap and through which lights are emitted from the diodes toward an outside of the apparatus, as taught by Venkatraman, because the modification would provide an optical sensor to detect, sense, sample and/or generate data that may be used to determine information representative of, for example, stress (or level thereof), blood pressure, and/or heart rate of a user (Venkatraman; [0124]).
Regarding claim 22, Lee further discloses (Figures 1 and 10) that the physiologic parameter is one of: a heart rate, a respiration rate, and a blood oxygen saturation level ([0018], [0051]).
Regarding claims 23-24, the modified device includes the teachings of Sun, which teaches that the controller is configured to, when the state of the wearable device is set to the sleep state during a measurement of the physiologic parameter, discard the measured physiologic parameter; and that the controller is configured to, after discarding the measured physiologic parameter, wait for another low active time period or another inactive time period before performing another measurement of the physiologic parameter (Sun; [0034]-[0035], [0039]-[0040], [0056], [0063]: while the accelerometer and biosensor are run simultaneously and the accelerometer determines that the device is in a sleep/high active state, the biosensor measurement is discarded and the accelerometer readings are analyzed again to determine when the device is in a low active/inactive time period to perform another actual measurement of the biosensor).
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Lee/Venkatraman/Colburn/Loree/Sun/Thomson, as applied to claim 1 above, and further in view of Braintree Analytics LLC, (WO 2016040253; hereinafter Braintree).
Regarding claim 3, Lee/Venkatraman/Colburn/Loree/Sun/Thomson fails to teach that two or more electrodes are disposed in a region adjacent to a terminus of the strap and an activatable biasing element on the opposite surface of the strap behind the two or more electrodes, wherein the activatable biasing element comprises one of: a mechanical bias, an electromechanical bias, and a magnetic bias. However, Braintree teaches a wrist-worn heart monitor apparatus for monitoring a patient, including an activatable biasing element (pressure actuator) on the opposite surface of the strap behind two or more electrodes (pressure sensors), wherein the activatable biasing element comprises one of: a mechanical bias (fluid bladder), an electromechanical bias (linear actuator), and a magnetic bias (solenoid), ([0122], [0127], [0167]-[0171], [0188]: each pressure actuator may be individually controlled to drive the sensors against the wrist). As shown in Figure 49B, there may be pairs of electrodes ([0214]: the device has at least a first pair of electrodes 976, and therefore may have multiple pairs of electrodes 976) at opposite regions of the strap adjacent to a terminus of the strap. Since each electrode will have a respective pressure actuator associated with it, the pressure actuators of the pair of electrodes on one side of the strap would be located opposite from the region of the apparatus opposite from the region of the strap comprising the other pair of electrodes (on the opposite surface of the strap behind the two or more electrodes). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee/Venkatraman/Colburn/Loree/Sun/Thomson such that two or more electrodes are disposed in a region adjacent to a terminus of the strap and an activatable biasing element on the opposite surface of the strap behind the two or more electrodes, wherein the activatable biasing element comprises one of: a mechanical bias, an electromechanical bias, and a magnetic bias, as taught by Braintree, because the modification would provide constant pressure to urge the sensor against the wrist (Braintree, [0122]) for efficient sensing.
Regarding claim 6, Lee/Venkatraman/Colburn/Loree/Sun/Thomson/Braintree further teaches that the controller is configured to passively activate and inactivate the activatable biasing element to drive the two or more electrodes against the wrist when worn on the wrist and to trigger sensing and acquisition of data by the two or more electrodes. Specifically, the modified device includes the activatable biasing element taught by Braintree, which may be passively activated and inactivated to drive the electrodes against the wrist when worn on the wrist and trigger sensing and acquisition of data by the electrodes (which is accomplished using a controller as in Lee), ([0022]-[0023]).
Claim 25-26 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Lee/Venkatraman/Colburn/Loree/Sun/Thomson, as applied to claim 1 above, and further in view of Matichuk et al., (US 20180301224; hereinafter Matichuk).
Regarding claims 25-26, Lee/Venkatraman/Colburn/Loree/Sun/Thomson fails to teach wherein the wearable device is configured to notify a user of a low battery condition by lighting up; further comprising: one or more LEDs embedded in the strap and illuminated to notify the low battery condition. However, Matichuk (Figures 1 and 3A-3B) teaches a wearable device (100) comprising one or more LEDs (186) embedded in the strap and illuminated to notify a low battery condition, wherein the wearable device is configured to notify a user of a low battery condition by lighting up the LEDs (186), ([0090]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee/Venkatraman/Colburn/Loree/Sun/Thomson to include wearable device comprising one or more LEDs embedded in the strap and illuminated to notify a low battery condition, wherein the wearable device is configured to notify a user of a low battery condition by lighting up the LEDs, as taught by Matichuk, because the modification would easily inform the user regarding the status or states of the device, such as charging/battery condition (Matichuk; [0090]).
Regarding claim 28, Lee further discloses (Figures 1 and 10) wherein the strap includes a top (body) portion and a bottom (strap) portion, the top (body) portion is over-molded with a non-elastic material ([0107]: the top body portion is a rigid/non-elastic body carrying the electronics), and the bottom (strap) portion is made of an elastic material capable of stretching over a fist of the subject ([0107]: rubber material). Lee/Venkatraman/Colburn/Loree/Sun/Thomson fails to teach wherein the top portion includes a rigid flex printed circuit board (PCB) having traces that terminate with the two or more electrodes. However, Matichuk (Figure 1) teaches a wearable device (100) comprising a top portion (106) and a bottom portion (104), wherein the top portion (106) includes a rigid flex PCB (108) having traces that terminate with the sensors (182) of the device ([0129]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee/Venkatraman/Colburn/Loree/Sun/Thomson to include the top portion comprising a rigid flex PCB having traces that terminate with the two or more electrodes (which are the sensors in the modified device), as taught by Matichuk, because the rigid circuit boards would provide sufficient protection to the components thereon and the electronic circuitry, including the PCBs and components thereon, can be made with a small size and/or thickness for easily fitting into a body portion (Matichuk; [0130]).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Lee/Venkatraman/Colburn/Loree/Sun/Thomson, as applied to claim 1 above, and further in view of Weast et al., (US 20130110264; hereinafter Weast).
Regarding claim 27, Lee/Venkatraman/Colburn/Loree/Sun/Thomson fails to teach wherein the controller is configured to: record the counter value over a duration for each day of a week, determine a best time of day to perform the measurement of the physiologic parameter for each day of the week based on the recorded counter values, and trigger the measurement at the computed best time of day. However, Weast teaches (Figure 2) a wearable device (10), wherein a controller is configured to: record activity over a duration for each day of a week, determine a best time of day to perform the measurement of a physiologic parameter for each day of the week based on the recorded counter values, and trigger the measurement at the computed best time of day ([0294]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee/Venkatraman/Colburn/Loree/Sun/Thomson to include the controller being configured to: record the counter value over a duration for each day of a week, determine a best time of day to perform the measurement of the physiologic parameter for each day of the week based on the recorded counter values, and trigger the measurement at the computed best time of day, as taught by Weast, because the modification may aid in determining days for which activity needs to be improved (Weast; [0294]). Furthermore, in the modified device, the activity would be recorded according to the counter values of the wearable device.
Response to Arguments
Applicant’s arguments filed 02/19/2026 have been fully considered.
Applicant’s argument that the cited combination of references fail to teach the newly amended claim limitations of claim 1 is persuasive. Therefore, the rejection(s) of claim 1 has/have been withdrawn. However, a new grounds of rejection is made in view of newly found prior art reference Thomson, which teaches a wearable device which may be configured without a display or output. Instead, the device may rely on communication with a base station such as a mobile telecommunications device to display and/or analyze the signal. In combination with Lee/Venkatraman/Colburn/Loree/Sun, the modified device teaches the invention as claimed in at least the newly amended independent claim 1. Furthermore, in response to Applicant’s argument that Venkatraman teaches away from the claimed measurement policy of claim 1, Examiner notes that Venkatraman is not used to teach the measurement policy of the modified device. Rather, Venkatraman is only used to teach using an accelerometer for the user’s motion detection. Therefore, Examiner maintains that the rejections using the Venkatraman reference remain tenable.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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