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 § 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.
Claims 8 and 23 are 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 8 recites the limitation "the vital signal" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the vital signal" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6, 8-11 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Eggers et al [US 2022/0022758] in view of Sarkar et al [US 2020/0121187]
Claim 1. (currently amended): A notification method comprising: detecting a degree of anomaly of a person from electrocardiogram data of the person measured with a wearable device (the wearable cardiac arrest ECG detection and alerting device 10, see Figs. 1-3, para [0059, 0060, 0074]);
determining a level of emergency of an anomaly of the person based on the degree of
anomaly (the selecting, from among response data representing a content of a
response to be notified to the person or to a third party set in advance, the response
data in accordance with the level of emergency (the selection between CPR and/or AED
information among the response over a short time periods according to the level of
intervention for an individual suffering a cardiac arrest has occurred or is imminent
respective to minimum preselected levels indicative of a functioning heart, blood flow
rate level and/or below a specified minimum pressure level and to alert to a family
member, neighbor, nursing staff, doctor and/or emergency services, see Figs. 5-9, para
[0005-0014, 0016, 0021, 0039, 0040, 0060, 0069]); and
providing a notification corresponding to the selected response data (the present
disclosure overcomes the critical need to immediately alert potential first responders
(e.g., family member(s), co-workers, fitness facility staff, neighbor(s), assisted living
facility staff, hotel staff, or any individual with an application on their smart phone or
smart device that informs them of a cardiac arrest event and its location) prior to the
arrival of professional emergency medical services by detecting that a cardiac arrest
has occurred, immediately issuing an audible alarm, and then dialing pre-established
phone numbers to alert potential first responders with [a] the individual's name, [b]
individual's exact location including GPS-derived latitude and longitude coordinates, [c]
time of occurrence of cardiac arrest and, optionally, [d] the location of nearest AED
device(s) in the event the nearest AED device(s) is(are) geocoded into a data base
accessible by a server (see para [0011, 0040, 0043]). But
Eggers et al fails to disclose based on the level of emergency being lower than a
preset criterion, outputting medical interview data representing a content of a
medical interview to the person, and acquiring answer data representing an answer to
the medical interview data input from the person; and determining the level of
emergency based on the answer data. However,
Eggers et al teaches that the system, and method of the present disclosure utilizes a wearable cardiac arrest detection and alerting device that minimizes the probability of a false indication of cardiac arrest (see abstract).
Although widely available CPR training and fully automated AED technology now exists to provide for prompt intervention when an individual suffers a cardiac arrest and becomes unconscious. As a result, even though an AED device may be present in the office and co-workers trained in its use (see para [0010]).
The accessory cellular phone and programmable device 39 includes [a] wireless communication hardware and software (e.g., Bluetooth ultra-high frequency transmitter) to receive heart-rate values from the wearable cardiac arrest detection and alerting device [b] algorithm to continuously analyze measured photon signal data received from the wearable cardiac arrest detection and alerting device to determine whether the measured photon signals are within a predetermined range to confirm that wearable cardiac arrest detection and alerting device is properly functioning and is properly positioned on the individual being monitored and, if measured photon signal levels are within a pre-determined range, continuously derive heart rate value, [c] ultrasound transmitter and receiver to enable Doppler ultrasound-based measurement or laser diode and photodetector to enable laser Doppler-based measurement of blood flow rate, [d] algorithm to continuously analyze measured heart rate values and measured blood flow rate values to determine whether both are below predetermined levels indicative that a cardiac arrest has occurred or is imminent (see Fig. 6, para [0066]).
The requirement that two or more different types of non-invasive heart function measurements must below predetermined levels to represent the occurrence of cardiac arrest significantly reduces the probability of a false indication of the occurrence of a cardiac arrest in the event that the measured heart function by as many as one of two methods (or two of three methods or three of four methods for heart function measurement) result in a measured heart function parameter that is below a predetermined level due, by way of example, to such factors as movement artifact and/or inadequate contact pressure between the measurement apparatus and the subject's body (see para [0014]).
Sarkar et al suggests that the lower resolution diagnostic information may be transmitted from a plurality of IMDs implanted in different patients to healthcare professionals through different methods and different channels. In this manner, for example, the heart failure risk level may help the healthcare professionals to triage patient care and first assist those patients at highest risk for hospitalization. A remote computing device 120A may receive the remotely transmitted lower resolution diagnostic information and present each patient ranked according to the risk levels, e.g., from highest to lowest risk levels (see para [0035]).
The computing device 120A or programmer 24, for example, may be remote computing devices that receive and present lower resolution diagnostic information transmitted from IMDs of multiple patients so that a clinician may prioritize the patients needing treatment immediately. In other words, the clinician may triage patients by analyzing the heart failure risk levels of multiple patients. The computing device may use its communication module to receive the lower resolution diagnostic information (e.g., heart failure risk levels) transmitted from multiple IMDs via network 112. In this manner, each heart failure risk level is representative of one the patients. Although the IMDs may transmit the lower resolution diagnostic information at any time, generally the IMDs may transmit lower resolution diagnostic information on a daily basis or in response to an interrogation request from an external computing device 120A. In other examples, the IMDs may be configured to transmit lower resolution diagnostic information when the risk level becomes critical or there is a medium or high risk of re-hospitalization within a predetermined period. A processor within the remote computing device may then automatically rank each of the patients based on each of the heart failure risk levels and the user interface may present the list of ranked patients to the clinician. Generally, the list will start with the most critical patient, e.g., the highest risk level, at the top (see Fig. 5, para [0143]).
Risk level 144 and patient metrics 142 may be considered lower resolution diagnostic information. This data of screen 130 may be lower resolution because it is transmitted to the user at a low frequency, e.g., once per day or less, or it includes data detected and stored at a low frequency, e.g., once a day or less. In other words, the lower resolution diagnostic information may include a simplified indication of the patient risk than would otherwise be present in the raw data acquired from the patient (see Fig. 6, para [0149]).
If IMD 16 does receive an interrogation request for admitting patient 14 to a hospital ("YES" branch of block 214), IMD 16 transmits the requested patient metrics from memory 82 within IMD 16 (216). In some examples, the patient metrics may be transmitted as higher resolution diagnostic information, e.g., patient metric values over a previous time period. In other examples, IMD 16 may transmit lower resolution diagnostic information, e.g., a heart failure risk level and/or a single recent patient metric value. IMD 16 may transmit lower resolution diagnostic information to emergency personnel not familiar with individual patient metrics, but higher resolution diagnostic information may be transmitted to a clinician that in trained in making a treatment or admission decision based on the patient metrics. If patient 14 is not admitted to the hospital ("NO" branch of block 218), IMD 16 may revert back to the previous monitoring mode (212) (see Fig. 10, para [0176]).
Therefore, it would have been obvious to one skill in the art before the effective filing date of the invention to use or implement the method of the patent IMD 16 may transmit lower resolution diagnostic data information of a heart failure/risk of a patient to the remoting computing device of emergency personnel or trained clinic technician to review the data information and to determine whether there is low/high critical heart risk level, then answering back if that patient is submitting to the hospital or not according to the reviewed of his/her heart risk conditions of Sarkar et al to the accessory cellular phone and programmable device 39 includes [a] wireless communication hardware and software (e.g., Bluetooth ultra-high frequency transmitter) to receive heart-rate values from the wearable cardiac arrest detection and continuous analyze the received data information and to determine of cardiac emergency level of Eggers et al for assuring and preventing of false emergency situation for providing efficiency and reliable of emergency operations to save people life necessary.
Claim 2. (Original): The notification method according to Claim 1, comprising selecting
the response data in accordance with the level of emergency from among the response
data including the response data representing a content of a response by the person
and the response data representing a content of a response by the third party (as cited
in respect to claim 1 above, and wherein the third party such as the skill nurses and/or
professional emergency medical services represent the data information and promptly
commence the CPR and/or AED with respect to that individual under heart arrest levels,
see para [0010, 0011, 0043]).
Claim 3. (Original): The notification method according to Claim 2, comprising selecting
the response data in accordance with the level of emergency from among the response
data including the response data representing a content of a response in which the
person contacts a medical institution and the response data representing a content of a
response in which the medical institution serving as the third party measures an
electrocardiogram of the person (as cited in respect to claims 1 and 2 above, wherein
the third party is the hospital skill nursing staffs and professional emergency medical
services, see Eggars et al, para [0010, 0011]).
Claim 4. (previously presented): The notification method according to Claim 1, comprising determining the level of emergency of the anomaly of the person based on the degree of anomaly and on record data related to a body of the person (the cardiac arrest is different from, but may be caused by, a heart attack, where blood flow to the muscle of the heart is impaired. It is different from congestive heart failure wherein the blood circulation level is below normal, but the heart is still pumping sufficient blood to sustain life. It is known that a number of risk factors can contribute to one of the principal causes of cardiac arrest, viz., a delayed repolarization of the heart following a heart beat, an effect known as the Long QT Syndrome, see Eggars et al, para [0004, 0014, 0016, 0021]).
Claim 5. (previously presented): The notification method according to Claim 1, comprising determining the level of emergency of the anomaly of the person based on a physical condition of the person acquired with the wearable device (reads upon the heart rate and blood flow rate level of a wearer are within normal pre-programmed physiological range to provide data necessary to determine whether cardiac arrest or imminent cardiac arrest has occurred, as seen at arrow 84 and block 86, see Eggars et al, Fig. 7A, para [0085]).
Claim 6. (previously presented): The notification method according to Claim 1, comprising: calculating likelihood of the degree of anomaly detected from the electrocardiogram data; and determining the level of emergency of the anomaly of the person based on the likelihood (as cited in respect to claim 1 above, and including the algorithm and calculated, see Eggars et al, para [0016, 0017, 0060, 0064, 0066, 0069, 0078]);
Claim 7. (canceled).
Claim 8. (currently amended): The notification method according to Claim 7, comprising: outputting the medical interview data with the content of the medical interview changed based on the vital sign data representing a physical condition of the person acquired with the wearable device (as the combination of the interview or review between Eggers et al and Sarkar et al in respect to claim 1 above, and the cardiac emergency alert based on the audible blood flow in a vital pulsatile manner and/or lungs are no longer expanding and contracting inducing air flow associated with vital breathing in the individual wearing the device, see Eggars et al, Figs. 7B, 9, para [0081, 0082).
Claim 9. (Currently Amended): The notification method according to Claim 1, comprising: in a case where the level of emergency is higher than a preset criterion, receiving a consent by the person to provide data related to a body of the person to the third party; and notifying the data related to the body of the person to the third party when receiving the consent (as cited in respect to claims 1-3 above, and reads upon if measured one or more sensor signals are not within range of pre-determined one or more sensor signal levels, then wearable cardiac arrest detection and alerting device issues audible and display cues as well as a vibration (i.e., haptic) alert to individual being monitored indicating that wearable cardiac arrest detection and alerting device 10 is not properly positioned on individual, as seen at arrow 82 and block 83. As a consequence, the individual is alerted to securely position wearable cardiac arrest detection and alerting device 10, as seen at arrow 85 and block 72 and repeat subsequent steps leading to block 80 (see Eggars et al, Fig. 7B, para [0084]).
Claim 11. (Currently Amended): A notification apparatus comprising: at least one
memory storing processing instructions; and at least one processor configured to
execute the processing instructions to: detect a degree of anomaly of a person from
electrocardiogram data of the person measured with a wearable device; determine a
level of emergency of an anomaly of the person based on the degree of anomaly;
based on the level of emergency being lower than a preset criterion, outputting medical interview data representing a content of a medical interview to the person, and acquiring answer data representing an answer to the medical interview data input from the person; and determining the level of emergency based on the answer data: select
from among response data representing a content of a response to be notified to the
person or to a third party set in advance, the response data in accordance with the level
of emergency; and provide a notification corresponding to the selected response data
(as the combination between Eggers et al and Sarkar et al in respect to claims 1-3 above, and including the apps processing and computer instructions, see Eggars et al, para [0019, 0039, 0060, 0065]).
Claims 12-20 (Canceled)
Claim 21. (current amended): A non-transitory computer-readable storage medium in which a program is stored), the program comprising instructions for causing a computer to execute processes to detect a degree of anomaly of a person from electrocardiogram data of the person measured with a wearable device; determine a level of emergency of an anomaly of the person based on the degree of anomaly; based on the level of emergency being lower than a preset criterion, outputting medical interview data representing a content of a medical interview to the person, and acquiring answer data representing an answer to the medical interview data input from the person; and determining the level of emergency based on the answer data; select, from among response data representing a content of a response to be notified to the person or to a third party set in advance, the response data in accordance with the level of emergency; and provide a notification corresponding to the selected response data (as the combination between Eggers et al and Sarkar et al in respect to claims 1-3 above and including the non-transitory storage medium, see Eggars et al, claims 6, 9).
Claim 22. (previous presented): The notification method according to Claim 1, comprising detecting the degree of anomaly of the person using an evaluation model generated through machine learning (as cited in respect to claim 1 above and including the analyze measured, Fourier Analysis, component analysis and/or evaluation using a programmable device and responds to the alert according to a pre-programmed set of computer instructions and a machine, see Eggars et al, para [0016, 0019, 0024, 0060, 0064, 0069]).
Claim 23. (new): The notification method according to Claim 1, comprising selecting the medical interview data that was changed based on the vital signs data representing a physical condition of the person acquired with the wearable device from stored medical interview data, and outputting the medical interview data (as the combination between Eggers et al and Sarkar et al in respect to claim 1 above, and furthermore, Sarkar et al teaches that the risk level 144 and patient metrics 142 may be considered lower resolution diagnostic information. This data of screen 130 may be lower resolution because it is transmitted to the user at a low frequency, e.g., once per day or less, or it includes data detected and stored at a low frequency, e.g., once a day or less. In other words, the lower resolution diagnostic information may include a simplified indication of the patient risk than would otherwise be present in the raw data acquired from the patient (see Fig. 6, para [0149]).
Therefore, it would have been obvious to one skill in the art before the effective filing date of the invention to implement the remote stored detection data of Sarkar et al to the remote server machine and computer software of Eggers et al that waits for an alert via cellular communication from a wearable device and responds to an alert according to a pre-programmed set of computer instructions. The storing of patient cardiac data information is for further studying and as a medical history of that patient under heart attacked.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Eggers et
al [US 2022/0022758] and Sarkar et al [US 2020/0121187] and further in view of Yang et al [CN 107230324 A]
Claim 10. Eggers et al fails to disclose performing a process to unlock a place in which
the person is located in a case where the level of emergency is higher than a preset
criterion. However,
Eggers et al teaches that the look-up table in software to determine whether wearable cardiac arrest detection and alerting device is at any of the pre-programmed locations frequented by the individual being monitored by the wearable cardiac arrest detection and alerting device (e.g., locations, such as, for example, individual's home, another home, office, fitness facility, or the like (see para [0016, 0017, 0060, 0066]).
Yang et al suggests that the safety monitoring, early warning and rescue dispatching
system and a safety monitoring, early warning and rescue dispatching method for the
elderly. The safety monitoring, early warning and rescue dispatching system comprises
a sign monitoring bracelet, an intelligent communication terminal, a safety electronic
door lock, an intelligent navigation ambulance and an emergency call center, wherein
the sign monitoring bracelet is worn on a hand of the elderly, and monitors a heart rate
and six-axis motion data of the elderly; the sign monitoring bracelet is connected with
the intelligent communication terminal in a wireless manner; the intelligent
communication terminal receives data of the sign monitoring bracelet, and transmits the
data to the emergency call center by means of a WiFi or 4G network; and the
emergency call center dispatches the intelligent navigation ambulance to arrive at
the home of the elderly, and unlocks the safety electronic door lock quickly by means of
a safety digital key pre-saved in the emergency call center. The safety monitoring, early
warning and rescue dispatching system and the safety monitoring, early warning and
rescue dispatching method have the danger monitoring, early warning and rescue
dispatching functions, and can avoid the occurrence of tragic events caused by the
situations that the elderly encounter accidental circumstances such as falling or
sudden illness and cannot get timely medical treatment (see abstract).
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 response or rescuer to unlock the door of
an ECG emergency elderly location of Yang et al to the look-up table of Eggers et al
and Sarkar et al for an emergency rescuer or responder quickly and timely to located and opening the door to access to a person under heart arrest or heart attack for saving a life.
Response to Arguments
Applicant’s arguments, see the amendment, filed 04/01/2026, with respect to the rejection(s) of claims 1-11, 21 and 22 under Eggers et al and Mazar et al have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sarkar et al to make the rejection smoother.
Applicant’s arguments:
(A) The combination of Eggers and Mazar (cited for allegedly disclosing the
following features previously claim 7 in pages 7-9 of the Office Action) does not teach or
suggest "based on the level of emergency being lower than a preset criterion, outputting medical interview data representing a content of a medical interview to the person, and acquiring answer data representing an answer to the medical interview data input from the person" and "determining the level of emergency again based on the answer data."
(B) Claims 2-6, 8-10 and 22 depend from claim 1, and therefore these claims are patentable at least by virtue of their dependencies, and because of the additional features recited therein.
Response to the arguments:
(A) It is obvious to combine the method of the patent IMD 16 may transmit lower resolution diagnostic data information of a heart failure/risk of a patient to the remoting computing device of emergency personnel or trained clinic technician to review the data information and to determine whether there is low/high critical heart risk level, then answering back if that patient is submitting to the hospital or not according to the reviewed of his/her heart risk conditions of Sarkar et al to the accessory cellular phone and programmable device 39 includes [a] wireless communication hardware and software (e.g., Bluetooth ultra-high frequency transmitter) to receive heart-rate values from the wearable cardiac arrest detection and continuous analyze the received data information and to determine of cardiac emergency level of Eggers et al for assuring and preventing of false emergency situation for providing efficiency and reliable of emergency operations to save people life necessary.
(B) The dependent claims are rejected by their independent claims respectively, as in (A) above.
Conclusion
Examiner is very regrettable to introduce a new Non-Final rejection based upon the update search and a new reference of is obviously combined to make the rejection smoother.
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. Wang Quan-Zhen can be reached on (571) 272-3114.
Examiner interviews are available via telephone, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only.
For more information about the PAIR system, see http://pair- direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786- 9199 (IN USA OR CANADA) or 571-272-1000.
/VAN T TRIEU/
Primary Examiner, Art Unit 2685
04/27/2026
Prosecution Insights