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 .
The amendment filed on December 9, 2025 has been received and considered. By this amendment, claims 1, 4-7, 9, 13-16, 20-22, 25, 26, 28, 29, 32 and 33 are amended, claims 8, 10, 11, 27, and 30 are cancelled, and claims 1-7, 9, 12-26, 28, 29, and 31-34 are now pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 29 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 29 recites the limitation "at least one of the ECU transmits the collected pulse oximetry data stored in the storage unit to the secondary device via a transmitter" in lines 5-6. The use of the term “at least one” suggests that there will be more than one thing recited after this phrase. However, there is only a single ECU recited and only a single function recited and, thus, it is unknown if there was intended to be more recited in the claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7, 9, 12-20, 22-26, 28, 29, and 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Workman (U.S. 2016/0066827, previously cited) in view of Kimura et al. (U.S. Patent No. 6,608,562, cited by Applicant). Regarding claims 1, Workman discloses a health monitoring system comprising: a finger band comprising an inner surface configured to at least partially surround a finger of a user (see Figures 1-3 and “a sensing module integrated within a wearable finger ring”, paragraph [0009]); one or more sensors including a pulse oximetry sensor disposed at the inner surface of the finger band and configured to collect sensor data including pulse oximetry representative of a heart rate and a blood oxygen level of the user (“The ring device can provide the user with various biometrics (e.g., heart rate, blood oxygen level, skin temperature, etc.)”, paragraph [0008]); an electronic control unit (ECU) disposed at the finger band and connected to the pulse oximetry sensor, the ECU comprising electronic circuitry and associated software, and the electronic circuitry comprising a data processor, a storage unit, and a transmitter (“The sensing module can include a processing unit configured to receive and process health readings received by the sensing module. A wireless transmitter can also be in communication with the processing unit.”, paragraph [0009]); wherein the pulse oximetry sensor collects pulse oximetry data and transmits the collected pulse oximetry data to the ECU during the sleep event (“The ring device can provide the user with various biometrics (e.g., heart rate, blood oxygen level, skin temperature, etc.)”, paragraph [0008]); wherein the ECU, when the finger band is worn by the user during the sleep event, receives the collected pulse oximetry data from the pulse oximetry sensor, processes the collected pulse oximetry data with the data processor, and stores the processed pulse oximetry data in the storage unit at a time interval of every 3 seconds or less (constant monitoring, as discussed at paragraph [0005] would result in storage every 3 seconds or less); and wherein the ECU, responsive to determining the finger band is removed from the user after the sleep event, transmits the processed pulse oximetry data stored in the storage unit to a remote device via the transmitter for monitoring sleep apnea (“A wireless transmitter can also be in communication with the processing unit. The wireless transmitter can be configured to transmit the processed health readings to a base station.”, paragraph [0009]). However, while Workman does disclose detecting abnormal pulse oximetry conditions that may indicate that the sensor has been removed (“abnormal readings can also consist of an absence of a pulse oximeter reading”, paragraph [0046]), Workman fails to disclose wherein the ECU is configured to determine the finger band is worn by the user based on data collected by the one or more sensors, or where the ECU is configured to determine the finger band is removed from the user based on the collected sensor data. Kimura teaches a vital sign detecting apparatus comprising a finger band 1/10 comprising an inner surface configured to at least partially surround a finger 11 of a user (see Figures 1, 5B, and 9-14), one or more sensors 23/901-903 disposed at the inner surface of the finger band configured to collect sensor data (see Figures 1, 5B, and 9-14 and “The photo diode 23 is disposed at the bottom of the inside of the attachable device 1 where it can receive this returning light”, col. 6, ln. 60-62), and an electronic control unit (ECU) 4/31/90 disposed at the finger band and connected to the at least one or more sensors (see Figures 1, 5B, and 9-14), wherein the ECU is configured to determine the finger band is worn by the user based on data collected by the one or more sensors, and wherein the ECU is configured to determine the finger band is removed from the user based on the collected sensor data (“At step 103 the attachment detecting circuit 3 determines whether or not the attachable device 1 is fitted. When it determines that it is fitted (YES), processing proceeds to step 104. When it determines that it is not fitted (NO), processing proceeds to step 106.”, col. 5, ln. 32-36, and “The insertion detection circuit 30 is made up of a microcomputer 31, a switch 32, a planar 33, a spring 34, a plunger case 35 and a resistor 36. It determines whether or not the finger 11 has been inserted into the finger insertion cylinder 10.”, col. 7, ln. 5-9). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the ECU of Workman such that it is configured to determine the finger band is worn by the user based on data collected by the one or more sensors and configured to determine the finger band is removed from the user based on the collected sensor data, as taught by Kimura, in order to conserve battery power and enable monitoring only during sleep periods, and as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 2, Workman discloses that the pulse oximetry sensor comprises a light emitter for directing infrared and red wavelengths of light at the user and a light detector for receiving infrared and red wavelengths of light from the user (“In at least one implementation, using multiple photo diodes and LED lights, it is possible to increase the amount of light received into the processing unit and increase the DC signal to get better and more accurate pulse oximetry readings.”, where the photo diodes and LED lights would be “for directing infrared and red wavelengths of light” and “for receiving infrared and red wavelengths of light”, as these are the intended uses of these elements).
Regarding claim 3, Workman discloses that the light emitter is disposed at a first location at the inner surface of the finger band and when electrically powered, directs a beam of light along radial path, and wherein the light detector is disposed at a second location at the inner surface of the finger band remote from the first location and within the radial path (see annotated Figure below, where the radial path is shown, as it can be seen which elements would be located radially from each other when worn).
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Regarding claim 4, Workman discloses that the pulse oximetry sensor collects the pulse oximetry data at a time interval of every 1 second or less (constant monitoring, as discussed at paragraph [0005] would result in collection every 1 second or less).
Regarding claim 5, it is respectfully submitted that because the pulse oximetry sensor of Workman measures both heart rate and blood oxygen level on an ongoing basis (“For example, digital signal processing of light can be used to determine the heart rate of the individual using a well-known technology called pulse oximetry. Heart rate can be an important measurement in determining health, safety and emotion. Various implementations of sampling for blood oxygen levels can be implemented to reduce battery life such as sampling every 30 seconds versus constant monitoring.”, paragraph [0028]), any blood oxygen collection subsequent to a heart rate collection would be “in response to collecting pulse oximetry data representative of a heartbeat of the user”. As such, it is respectfully submitted that Workman satisfies the claims as currently recited.
Regarding claim 6, it is respectfully submitted that because the pulse oximetry sensor of Workman measures both heart rate and blood oxygen level on an ongoing basis (“For example, digital signal processing of light can be used to determine the heart rate of the individual using a well-known technology called pulse oximetry. Heart rate can be an important measurement in determining health, safety and emotion. Various implementations of sampling for blood oxygen levels can be implemented to reduce battery life such as sampling every 30 seconds versus constant monitoring.”, paragraph [0028]), any blood oxygen collection subsequent to a heart rate collection would be “at a time interval associated with a calculated heart rate of the user”. Furthermore, it is respectfully submitted that the recitation “the ECU is configured to trigger the pulse oximetry sensor to collect the pulse oximetry data at a time interval associated with a calculated heart rate of the user” is of such breadth that it is satisfied by the invention of Workman. It is respectfully submitted that the recitation “associated with” is not limited to a specific association, but would be satisfied by any association, including being satisfied by a continuous monitoring. As such, it is respectfully submitted that Workman satisfies the claims as currently recited. In order to overcome such a rejection, it is recommended that the association be defined to more detail provided as to the association.
Regarding claim 7, it is respectfully submitted that the recitation “the calculated heart rate of the user comprises an average heart rate of the user” further limits the broad limitation of claim 6 and would likewise be satisfied by the invention of Workman.
Regarding claim 9, Workman discloses that the one or more sensors comprises a contact sensor configured to collect contact data and the sensor data includes the contact data (“ Implementations of the ring device may also be able to determine the temperature of a user's skin and the ambient temperature around the ring device using one or more electronic thermometers (e.g., thermistors).”, paragraph [0033]).
Regarding claim 12, Workman discloses an actimetry sensor disposed at the finger band and configured to collect data representative of movement of the user (“Additionally, as disclosed above, in at least one implementation, the ring device can track sleep patterns. In particular, through heart rate and movement algorithms, data can be derived about the amount and the quality of a person's sleep. This can be valuable in helping them understand the best sleep environment and notify caregivers if a patient's sleep is suffering. Good sleep is tied to good health.”, paragraph [0031]).
Regarding claim 13, it is respectfully submitted that the recitation “the actimetry sensor, in response to the ECU determining the finger band is worn by the user, collects data representative of the movement of the user and transmits the collected data to the ECU during the sleep event, wherein the ECU, when the finger band is worn by the user during the sleep event, receives the collected data from the actimetry sensor and the pulse oximetry sensor, processes the collected data with the data processor, and stores the processed data in the storage unit” is directed to the intended use of the sensor and not to any further structural aspect of the sensor and, as such, fails to further define the claimed invention over that of the prior art which would be capable of performing the same use.
Regarding claim 14, it is respectfully submitted that the recitation “the ECU wirelessly transmits the processed pulse oximetry data stored in the storage unit to the remote device” is directed to the intended use of the sensor and not to any further structural aspect of the sensor and, as such, fails to further define the claimed invention over that of the prior art which would be capable of performing the same use.
Regarding claim 15, it is respectfully submitted that the recitation “the pulse oximetry sensor collects pulse oximetry data representative of the blood oxygen saturation at a frequency of greater than 0.50 Hz” is directed to the intended use of the sensor and not to any further structural aspect of the sensor and, as such, fails to further define the claimed invention over that of the prior art which would be capable of performing the same use.
Regarding claim 16, Workman discloses a method for measuring health data, the method comprising: providing a finger band to be worn by a user during a sleep event (see Figures 1-3 and “a sensing module integrated within a wearable finger ring”, paragraph [0009]) and comprising (i) one or more sensors including a pulse oximetry sensor disposed at an inner surface of the finger band (“The ring device can provide the user with various biometrics (e.g., heart rate, blood oxygen level, skin temperature, etc.)”, paragraph [0008]) and (ii) an electronic control unit (ECU) connected to the pulse oximetry sensor (“The sensing module can include a processing unit configured to receive and process health readings received by the sensing module. A wireless transmitter can also be in communication with the processing unit.”, paragraph [0009]); collecting pulse oximetry data representative of a blood oxygen level and a heart rate of the user via the pulse oximetry sensor at a time interval of every 3 seconds or less and transmitting the collected pulse oximetry data to the ECU (“the ring device can track sleep patterns. In particular, through heart rate and movement algorithms, data can be derived about the amount and the quality of a person's sleep.”, paragraph [0031], and constant monitoring, as discussed at paragraph [0005] would result in storage every 3 seconds or less); while the finger band is worn by the user during the sleep event and responsive to receiving the collected pulse oximetry data at the ECU, processing the collected pulse oximetry data via a data processor of the ECU and storing the processed pulse oximetry data at a storage unit of the ECU; and after the finger band is removed from the user following the sleep event, transmitting the processed data stored at the storage unit to a remote device via a transmitter of the ECU (“A wireless transmitter can also be in communication with the processing unit. The wireless transmitter can be configured to transmit the processed health readings to a base station.”, paragraph [0009]). However, while Workman does disclose detecting abnormal pulse oximetry conditions that may indicate that the sensor has been removed (“abnormal readings can also consist of an absence of a pulse oximeter reading”, paragraph [0046]), Workman fails to disclose determining, at the ECU, whether the finger band is worn by the user during the sleep event based on sensor data collected by the one or more sensors, or determining, at the ECU, a conclusion of the sleep event based on the sensor data. Kimura teaches a vital sign detecting apparatus comprising a finger band 1/10 comprising an inner surface configured to at least partially surround a finger 11 of a user (see Figures 1, 5B, and 9-14), one or more sensors 23/901-903 disposed at the inner surface of the finger band configured to collect sensor data (see Figures 1, 5B, and 9-14 and “The photo diode 23 is disposed at the bottom of the inside of the attachable device 1 where it can receive this returning light”, col. 6, ln. 60-62), and an electronic control unit (ECU) 4/31/90 disposed at the finger band and connected to the at least one or more sensors (see Figures 1, 5B, and 9-14), wherein the ECU is configured to determine the finger band is worn by the user based on data collected by the one or more sensors, and wherein the ECU is configured to determine the finger band is removed from the user based on the collected sensor data (“At step 103 the attachment detecting circuit 3 determines whether or not the attachable device 1 is fitted. When it determines that it is fitted (YES), processing proceeds to step 104. When it determines that it is not fitted (NO), processing proceeds to step 106.”, col. 5, ln. 32-36, and “The insertion detection circuit 30 is made up of a microcomputer 31, a switch 32, a planar 33, a spring 34, a plunger case 35 and a resistor 36. It determines whether or not the finger 11 has been inserted into the finger insertion cylinder 10.”, col. 7, ln. 5-9). It is respectfully submitted that in the same way that Applicant’s removal of the finger band is used as a surrogate measure of the conclusion of the sleep event, the removal of the finger band detected by Kimura can likewise be used as a surrogate measure of the conclusion of the sleep event. As such, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Workman to include determining, at the ECU, whether the finger band is worn by the user during the sleep event based on sensor data collected by the one or more sensors and determining, at the ECU, a conclusion of the sleep event based on the sensor data, as taught by Kimura, in order to conserve battery power and enable monitoring only during sleep periods, and as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 17, Workman discloses that the ECU is disposed at the finger band (“The sensing module can include a processing unit configured to receive and process health readings received by the sensing module. A wireless transmitter can also be in communication with the processing unit.”, paragraph [0009]).
Regarding claim 18, Workman discloses that the ECU may be remote from the finger band (“Those skilled in the art will appreciate that the invention may be practiced in network computing environments with many types of computer system configurations, including, personal computers, desktop computers, laptop computers, message processors, hand-held devices, multi-processor systems, microprocessor-based or programmable consumer electronics, network PCs, minicomputers, mainframe computers, mobile telephones, PDAs, tablets, pagers, routers, switches, and the like.”, paragraph [0059]).
Regarding claim 19, Workman discloses that the ECU may be disposed at the remote device (“Those skilled in the art will appreciate that the invention may be practiced in network computing environments with many types of computer system configurations, including, personal computers, desktop computers, laptop computers, message processors, hand-held devices, multi-processor systems, microprocessor-based or programmable consumer electronics, network PCs, minicomputers, mainframe computers, mobile telephones, PDAs, tablets, pagers, routers, switches, and the like.”, paragraph [0059]).
Regarding claim 20, it is respectfully submitted that because the pulse oximetry sensor of Workman measures both heart rate and blood oxygen level on an ongoing basis (“For example, digital signal processing of light can be used to determine the heart rate of the individual using a well-known technology called pulse oximetry. Heart rate can be an important measurement in determining health, safety and emotion. Various implementations of sampling for blood oxygen levels can be implemented to reduce battery life such as sampling every 30 seconds versus constant monitoring.”, paragraph [0028]), any blood oxygen collection subsequent to a heart rate collection would be “at a time interval representative of the heart rate of the user”. Furthermore, it is respectfully submitted that the recitation “the ECU is configured to trigger the pulse oximetry sensor to collect pulse oximetry data representative of the blood oxygen level of the user at a time interval representative of the heart rate of the user” is of such breadth that it is satisfied by the invention of Workman. It is respectfully submitted that the recitation “representative of” is not limited to a specific representation, but would be satisfied by any representation, including being satisfied by a continuous monitoring. As such, it is respectfully submitted that Workman satisfies the claims as currently recited. In order to overcome such a rejection, it is recommended that the representation be defined in more detail provided as to the association.
Regarding claim 22, Workman discloses a health monitoring system comprising: a wearable band device comprising an inner surface configured to at least partially surround an extremity of a user (see Figures 1-3 and “a sensing module integrated within a wearable finger ring”, paragraph [0009]); one or more sensors including a pulse oximetry sensor disposed at the inner surface of the wearable band device (“The ring device can provide the user with various biometrics (e.g., heart rate, blood oxygen level, skin temperature, etc.)”, paragraph [0008]) and comprising a light emitter for transmitting infrared and red wavelengths of light through the extremity of the user and a light detector for receiving the infrared and red wavelengths of light from the user (“In at least one implementation, using multiple photo diodes and LED lights, it is possible to increase the amount of light received into the processing unit and increase the DC signal to get better and more accurate pulse oximetry readings.”, where the photo diodes and LED lights would be “for directing infrared and red wavelengths of light” and “for receiving infrared and red wavelengths of light”, as these are the intended uses of these elements); an electronic control unit (ECU) electrically connected to the pulse oximetry sensor, the ECU comprising electronic circuitry and associated software, and the electronic circuitry comprising a data processor a storage unit (“The sensing module can include a processing unit configured to receive and process health readings received by the sensing module. A wireless transmitter can also be in communication with the processing unit.”, paragraph [0009]); wherein the pulse oximetry sensor, collects pulse oximetry data representative of a heart rate and a blood oxygen level of the user during a sleep event and transmits the collected pulse oximetry data to the ECU during the sleep event (“the ring device can track sleep patterns. In particular, through heart rate and movement algorithms, data can be derived about the amount and the quality of a person's sleep.”, paragraph [0031]); wherein the ECU receives the collected pulse oximetry data from the pulse oximetry sensor, processes the collected pulse oximetry data with the data processor, and stores the processed data in the storage unit at a time interval of every 2 seconds or less (constant monitoring, as discussed at paragraph [0005] would result in storage every 2 seconds or less); and wherein, when the wearable band device is removed from the user after the sleep event, the data stored in the storage unit is processed by at least one of the ECU or a secondary device for detecting, diagnosing, or monitoring sleep apnea (“A wireless transmitter can also be in communication with the processing unit. The wireless transmitter can be configured to transmit the processed health readings to a base station.”, paragraph [0009]). However, while Workman does disclose detecting abnormal pulse oximetry conditions that may indicate that the sensor has been removed (“abnormal readings can also consist of an absence of a pulse oximeter reading”, paragraph [0046]), Workman fails to disclose wherein the ECU is configured to determine the finger band is worn by the user based on data collected by the one or more sensors, or where the ECU is configured to determine the finger band is removed from the user based on the collected sensor data. Kimura teaches a vital sign detecting apparatus comprising a finger band 1/10 comprising an inner surface configured to at least partially surround a finger 11 of a user (see Figures 1, 5B, and 9-14), one or more sensors 23/901-903 disposed at the inner surface of the finger band configured to collect sensor data (see Figures 1, 5B, and 9-14 and “The photo diode 23 is disposed at the bottom of the inside of the attachable device 1 where it can receive this returning light”, col. 6, ln. 60-62), and an electronic control unit (ECU) 4/31/90 disposed at the finger band and connected to the at least one or more sensors (see Figures 1, 5B, and 9-14), wherein the ECU is configured to determine the finger band is worn by the user based on data collected by the one or more sensors, and wherein the ECG is configured to determine the finger band is removed from the user based on the collected sensor data (“At step 103 the attachment detecting circuit 3 determines whether or not the attachable device 1 is fitted. When it determines that it is fitted (YES), processing proceeds to step 104. When it determines that it is not fitted (NO), processing proceeds to step 106.”, col. 5, ln. 32-36, and “The insertion detection circuit 30 is made up of a microcomputer 31, a switch 32, a planar 33, a spring 34, a plunger case 35 and a resistor 36. It determines whether or not the finger 11 has been inserted into the finger insertion cylinder 10.”, col. 7, ln. 5-9). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the ECU of Workman such that it is configured to determine the finger band is worn by the user based on data collected by the one or more sensors and configured to determine the finger band is removed from the user based on the collected sensor data, as taught by Kimura, in order to conserve battery power and enable monitoring only during sleep periods, and as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 23, Workman discloses that the light emitter is disposed at a first location at the inner surface of the wearable band device and when electrically powered, directs a beam of Light along an radial path, and wherein the light detector is disposed at a second location at the inner surface of the wearable band device remote from the first location and within the radial path (see annotated Figure above, where the radial path is shown, as it can be seen which elements would be located radially from each other when worn).
Regarding claim 24, Workman discloses that the pulse oximetry sensor collects pulse oximetry data representative of the heart rate and the blood oxygen level of the user at a time interval of every 1 second or less (constant monitoring, as discussed at paragraph [0005] would result in collection every 1 second or less).
Regarding claim 25, it is respectfully submitted that because the pulse oximetry sensor of Workman measures both heart rate and blood oxygen level on an ongoing basis (“For example, digital signal processing of light can be used to determine the heart rate of the individual using a well-known technology called pulse oximetry. Heart rate can be an important measurement in determining health, safety and emotion. Various implementations of sampling for blood oxygen levels can be implemented to reduce battery life such as sampling every 30 seconds versus constant monitoring.”, paragraph [0028]), any blood oxygen collection subsequent to a heart rate collection would be “at a time interval representative of a calculated heart rate of the user”. Furthermore, it is respectfully submitted that the recitation “the ECU is configured to trigger the pulse oximetry sensor to collect pulse oximetry data representative of the blood oxygen level of the user at a time interval representative of a calculated heart rate of the user” is of such breadth that it is satisfied by the invention of Workman. It is respectfully submitted that the recitation “representative of” is not limited to a specific representation, but would be satisfied by any representation, including being satisfied by a continuous monitoring. As such, it is respectfully submitted that Workman satisfies the claims as currently recited. In order to overcome such a rejection, it is recommended that the representation be defined in more detail provided as to the association.
Regarding claim 26, it is respectfully submitted that the recitation “the pulse oximetry sensor collects pulse oximetry data representative of the blood oxygen saturation at a frequency of approximately 1 Hz” is directed to the intended use of the sensor and not to any further structural aspect of the sensor and, as such, fails to further define the claimed invention over that of the prior art which would be capable of performing the same use.
Regarding claim 28, Workman discloses that the one or more sensors comprises a contact sensor configured to collect contact data and the sensor data includes the contact data (“ Implementations of the ring device may also be able to determine the temperature of a user's skin and the ambient temperature around the ring device using one or more electronic thermometers (e.g., thermistors).”, paragraph [0033]).
Regarding claim 29, it is respectfully submitted that the recitation “in response to determining the wearable band device is removed from the user, at least one of the ECU transmits the collected pulse oximetry data stored in the storage unit to the secondary device via a transmitter” is directed to the intended use of the ECU and not to any further structural aspect of the sensor and, as such, fails to further define the claimed invention over that of the prior art which would be capable of performing the same use.
Regarding claim 30, it is respectfully submitted that the recitation “the sensor comprises the pulse oximetry sensor” further limits an intended use recitation that fails to further define the claimed invention over that of the prior art and, thus, fails to define the claimed invention over that of the prior art.
Regarding claim 31, Workman discloses an actimetry sensor disposed at the wearable band device and configured to collect data representative of movement of the user (“Additionally, as disclosed above, in at least one implementation, the ring device can track sleep patterns. In particular, through heart rate and movement algorithms, data can be derived about the amount and the quality of a person's sleep. This can be valuable in helping them understand the best sleep environment and notify caregivers if a patient's sleep is suffering. Good sleep is tied to good health.”, paragraph [0031]).
Regarding claim 32, it is respectfully submitted that the recitation “the actimetry sensor, in response to the ECG determining the wearable band device is worn by the user, collects data representative of the movement of the user and transmits the collected data to the ECU during the sleep event, wherein the ECU, when the wearable band device is worn by the user during the sleep event, receives the collected data from the actimetry sensor and the pulse oximetry sensor, processes the collected data with the data processor, and stores the processed data in the storage unit” is directed to the intended use of the sensor and not to any further structural aspect of the sensor and, as such, fails to further define the claimed invention over that of the prior art which would be capable of performing the same use.
Regarding claim 33, it is respectfully submitted that the recitation “the ECU wirelessly transmits the collected pulse oximetry data stored in the storage unit to the secondar device” is directed to the intended use of the sensor and not to any further structural aspect of the sensor and, as such, fails to further define the claimed invention over that of the prior art which would be capable of performing the same use.
Regarding claim 34, Workman discloses that the wearable band device is configured to surround the extremity of the user, the extremity comprising a finger, a wrist, a forearm, an upper arm, an ankle, a leg, a foot or a toe (“A biometric sensor can be disposed within a wearable finger ring.”, Abstract).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Workman (U.S. 2016/0066827) in view of Kimura (U.S. Patent No. 6,608,562) as applied to claims 1-7, 9, 12-20, 22-26, 28, 29, and 31-34 above, and further in view of Toth (U.S. 2019/0134396, previously cited). Workman in view of Kimura discloses the invention substantially as claimed, but fails to disclose calculating a hypoxic burden value. Toth teaches a method for monitoring physiologic parameters of a patient, including oxygen saturation and heart rate to detect apnea (“The sensing devices, as discussed above, may be configured to measure a wide variety of physiologic parameters of the subject including but not limited to ECG, EEG and/or EMG for measuring diaphragmatic parameters such as displacement, strength of contraction, EMG measurements, etc., hemoglobin (Hb) saturation, oxygen/carbon dioxide (O.sub.2/CO.sub.2) ratio from respiration, acoustic measurements (e.g., to sense airway obstruction, snoring, etc.), etc.”, paragraph [0108]), and includes calculating a hypoxic burden value (“Thresholds may relate to various physiologic parameters, including but not limited to:… exceeding preset hypoxemic burden (e.g., cumulative percentage of time under 90% saturation)”, paragraph [0124]) in order to accurately detect apneic events that require attention (“the modular physiologic monitoring system may apply stimulus in response to detecting events, where the events are based on certain thresholds meeting the definitions for events.”, paragraph [0124]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Workman in view of Kimura to include calculating a hypoxic burden value, as taught by Toth, in order to accurately detect apneic events that require attention.
Response to Arguments
Applicant’s arguments with respect to the claims 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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796