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 .
Response to Amendment
In response to amendments, filed June 28, 2025, claims 1-2, 5-6, 8-16, 20, and 22 have been amended. No claims have been cancelled. No claim have been added. Claims 1-22 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed June 28, 2025, with respect to objection of the specification have been fully considered and are persuasive in view of the amendments. The objection of the specification has been withdrawn.
Applicant's arguments with respect to 35 U.S.C 112 have been fully considered but they are not persuasive. Limitations within claims 5, 7, 9-10, 12-13, 17-19, and 22 fail to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Consistency of terminology and updating “a” to “the” for repeated limitations as appropriate for specificity is needed.
Applicant’s arguments with respect to the prior art have been considered but are moot because the new ground of rejection does not rely on the same reference combination applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A new ground(s) of rejection is made in view of the combinations of Jacquel/Greenspan/Cates/Kirenko/Abbas.
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 5, 7, 9-10, 12-13, 17-19, and 22 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.
Claims 5, 7, 9-10, 12-13, and 22 recite the limitation "the neonatal patient stimulation." There is insufficient antecedent basis for this limitation in the claim. If this limitation is to be in reference to the “vibration of a stimulation device attached to the incubator” in claim 1, updating for consistency of terms is required for antecedent basis.
Claim 17 recites “a critical alarm.” It is unclear whether the limitation refers to the same or different critical alarm recited in claim 16.
Claims 18 and 19 recite the limitation "a breathing event." It is unclear whether the limitations refer to the same or different breathing event first recited in claim 14.
Claims 18 and 19 recite the limitation "a significant desaturation event." It is unclear whether the limitations refer to the same or different significant desaturation event first recited in claim 14.
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) 1-5 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jacquel (US 20200046302 A1) in view of Greenspan (US 20100056879 A1).
Regarding claim 1, Jacquel teaches a video-based neonatal patient monitoring method ([0002] The present technology is generally related to video-based patient monitoring and to detection and monitoring of breathing of patients. [0026] video-based detection and/or monitoring of breathing in other animals and/or in non-patients [e.g., elderly or neonatal individuals within their homes]), comprising: generating depth images from a depth sensing camera having a field of view ([0028] The camera 114 can be a depth sensing camera, … the ROI can be monitored over time, and the changes in depth of regions [e.g., pixels] within the ROI 102 can represent movements of the patient 112 associated with breathing).
However, Jacquel fails to disclose an incubator. Greenspan teaches a method for maintaining homeostasis for a patient in a health care setting includes the steps of monitoring a physiological parameter and comparing the parameter against an expected parameter range. Greenspan discloses exposed to an incubator with a neonatal patient (Fig. 1, monitoring devices 108, controlled environment 106; [0017] In the depicted care setting 100, the patient 104 is located within a controlled environment 106. Such a patient in a controlled environment could, for example, be a neonate located in an incubator of a neonatal intensive care facility.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Jacquel to include an incubator as disclosed in Greenspan to improve health outcomes for infants by maintaining a controlled environment that prevents harsh temperature fluctuations and infection in the health care setting (Greenspan [0024]).
The combination of Jacquel/Greenspan further discloses:
the camera being aligned with the neonatal patient such that at least a portion of the neonatal patient is within the field of view; using changes in the depth images to calculate a neonatal patient breathing parameter (Jacquel: [0027] the video camera 114 of the non-contact detector 110; [0028] The camera 114 can be a depth sensing camera, … the ROI can be monitored over time, and the changes in depth of regions [e.g., pixels] within the ROI 102 can represent movements of the patient 112 associated with breathing … movements, or changes of regions within the ROI 102, can be used to determine various breathing parameters, such as tidal volume, minute volume, respiratory rate, etc; [0032] The captured images/video can be processed or analyzed at the computing device 115 and/or a server to determine a variety of parameters [e.g., tidal volume, minute volume, respiratory rate, etc.] of a patient's breathing.);
monitoring the calculated neonatal patient breathing parameter to identify the occurrence of a breathing event (Jacquel [0025] the systems and/or methods can overlay the assigned visual indicator[s] onto the captured images of the patient to indicate [i] whether the patient is breathing and/or, [ii] whether a patient's breathing is abnormal; [0060] the tidal volume signal 999 can be used to determine one or more abnormalities in the patient's breathing; [examples provided in [0061 and 0062]]);
and in response to the occurrence of the breathing event, initiating vibration of a stimulation device attached to the incubator (Jacquel: [0063] if the system detects a breathing abnormality, the system can trigger an audio and/or visual alarm to alert a user; Greenspan: [0023] For patients suffering from conditions such as sleep apnea, it is common to apply a waking stimulus to the patient as the appropriate corrective measure during an episode. … The apparatus includes a stimulus device 116 preferably located within the controlled environment 106 adjacent the patient 104 as shown and adapted to generate a waking stimulus. The waking stimulus could embody any of a variety of forms including audio, visual (e.g., flashing light), physical (e.g., vibrating bed or pillow), and scent. Fig. 1).
Regarding claim 2, the combination of Jacquel/Greenspan discloses the video-based neonatal patient monitoring method of claim 1 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), wherein the depth sensing camera is installed over the incubator (Jacquel: Fig. 1, depth sensing camera 114; [0028] the ROI can be monitored over time, and the changes in depth of regions [e.g., pixels] within the ROI 102 can represent movements of the patient 112 associated with breathing; Greenspan: Fig. 1, monitoring devices 108, controlled environment 106).
Regarding claim 3, the combination of Jacquel/Greenspan discloses the video-based neonatal patient monitoring method of claim 1 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), wherein the neonatal breathing parameter is respiratory volume (Jacquel: [0060] the tidal volume signal 999 can be used to determine one or more abnormalities in the patient's breathing; [examples provided in [0061 and 0062]]).
Regarding claim 4, the combination of Jacquel/Greenspan discloses the video-based neonatal patient monitoring method of claim 1 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), wherein the breathing event is apnea (Jacquel: [0046] detect a variety of medical conditions, such as apnea, rapid breathing [tachypnea], slow breathing, intermittent or irregular breathing, shallow breathing, and others; Fig. 9; [0088] if a patient's respiratory rate is and/or drops below a predetermined respiratory rate threshold value and/or range, the routine 1100 can determine that the patient is not breathing, that the patient is exhibiting apnea, and/or that the patient's breathing is restricted and/or impaired.).
Regarding claim 5, the combination of Jacquel/Greenspan discloses the video-based neonatal patient monitoring method of claim 1 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), wherein the neonatal patient stimulation further comprises one or more of: an auditory signal, a visual signal, or puffs of air stimulation (Jacquel: [0063] if the system detects a breathing abnormality, the system can trigger an audio and/or visual alarm to alert a user [e.g., the patient, the caregiver, the clinician, etc.]. Greenspan: [0023] The waking stimulus could embody any of a variety of forms including audio, visual (e.g., flashing light), physical (e.g., vibrating bed or pillow), and scent.).
Regarding claim 8, the combination of Jacquel/Greenspan discloses the video-based neonatal patient monitoring method of claim 1 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), further comprising:
tracking a duration of the breathing event; and initiating an alarm in response to the duration exceeding a predetermined amount of time (Jacquel: [0062] As shown, the tidal volume signal 999 in the plot 993 is relatively flat for the past 22.5 seconds, suggesting that the patient 112 has not been breathing for approximately that period of time. [0063] if the system detects a breathing abnormality, the system can trigger an audio and/or visual alarm to alert a user (e.g., the patient, the caregiver, the clinician, etc.). In the embodiment illustrated in FIG. 9, for example, the system has triggered a visual alarm 970 to alert a user that the patient 112 in the generated image 933 is exhibiting signs of apnea.).
Claim(s) 6-7, 9, 11-12, and 14-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jacquel (US 20200046302 A1) in view of Greenspan (US 20100056879 A1), and in further view of Cates (US 20200275882 A1).
Regarding claim 6, the combination of Jacquel/Greenspan discloses the video-based neonatal patient monitoring method of claim 1 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes).
However, the combination of Jacquel/Greenspan fails to explicitly disclose identifying termination of the breathing event. Cates teaches detecting ventilatory depression of a patient, and more specifically to a systems and method for providing patient stimulus when ventilatory depression is detected in a patient.
The combination of Jacquel/Greenspan/Cates discloses further comprising:
subsequent to initiating the vibration, monitoring the calculated neonatal patient breathing parameter to identify termination of the breathing event (Greenspan: [0023] The waking stimulus could embody any of a variety of forms including … physical (e.g., vibrating bed or pillow); Cates: [0070] The system 10 stops prompting the patient when SpO.sub.2 increases more than 4 percentage points from the nadir or above 90% for more than 10 seconds and respiratory rate is greater than 6-10 breaths/min… display module 45 will display the patient's historical and real-time ventilation status and/or conditions, the patient's historical and real-time level of movement, the patient's historical and real-time SpO2 levels and the patient's historical and real-time prompting protocol cycles and status. By providing this information on the display, a care giver can review the patient's breathing history and can see whether the patient has been self ventilating or has required breathing assistance by prompting from the system 40.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Jacquel/Greenspan to include identifying when the breathing event has terminated as disclosed in Cates to prevent delays of necessary patient care for patients in urgent need of help due to alarm fatigue and unnecessary workload for clinicians (Cates [0005]).
Regarding claim 7, the combination of Jacquel/Greenspan/Cates discloses the video-based neonatal patient monitoring method of claim 6 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), further comprising: terminating the neonatal patient stimulation when the breathing event has terminated (Cates: [0070] The system 10 stops prompting the patient when SpO.sub.2 increases more than 4 percentage points from the nadir or above 90% for more than 10 seconds and respiratory rate is greater than 6-10 breaths/min.).
Regarding claim 9, the combination of Jacquel/Greenspan/Cates discloses the video-based neonatal patient monitoring method of claim 6 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), further comprising:
increasing an intensity and/or frequency of the neonatal patient stimulation in response to a duration of the breathing event exceeding a predetermined amount of time (Cates: [0068] the level of vibration and/or electro-stimulation may be increased in each successive prompt to breathe if the patient is unresponsive).
Regarding claim 11, the combination of Jacquel/Greenspan/Cates discloses the video-based neonatal patient monitoring method of claim 6 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), further comprising:
recording data pertaining to each instance of the breathing event, the type of neonatal patient stimulation initiated in response to the breathing event, and whether the breathing event was terminated in response to the initiated stimulation (Cates: [0070] the display module 45 will display the patient's historical and real-time ventilation status and/or conditions, the patient's historical and real-time level of movement, the patient's historical and real-time SpO2 levels and the patient's historical and real-time prompting protocol cycles and status. By providing this information on the display, a care giver can review the patient's breathing history and can see whether the patient has been self ventilating or has required breathing assistance by prompting from the system 40);
identifying an effective type of neonatal patient stimulation based on the recorded data; and for subsequently identified breathing events, adaptively selecting the identified effective type of neonatal patient stimulation (Greenspan: [0023] The waking stimulus could embody any of a variety of forms including audio, visual (e.g., flashing light), physical (e.g., vibrating bed or pillow), and scent. The stimulus device 116 is controlled by a driver 118 in response to a signal from the CPU 110. According to one preferred embodiment, the control of the stimulus device 116 by CPU 110 is an adaptive process in that the CPU 110 stores each signal and integrates the errors so that the gain (proportional, differential and integrative feedback response) of the driver 118 is greater depending on the frequency and magnitude of each subsequent error. In addition, the driver 118 will preferably cascade the other feedback signals (oxygen, motion) to proportionally adapt the driver stimulus in a graded fashion; Cates: [0042] If the patient breathes in response to prompting from the system of the present invention three times in a row, the patient is deemed highly responsive to such prompts and are more likely continue to breathe for a period of time, at least up to 15 minutes, until a caregiver can attend to the patient; [0068] The system 10 also includes a microphone 16 for audio recording, a speaker 18 for providing audio prompts to the patient 20. The system also includes a tactile stimulator 38 that may be attached to the wrist of the patient 20 as shown or on the shoulder or other body location of the patient. The tactile stimulator 38 provides additional stimulation to the patient 20 when attempting to cause the patient to self-rescue if audio prompts alone are not successful. … In addition, the level of vibration and/or electro-stimulation may be increased in each successive prompt to breathe if the patient is unresponsive.).
Regarding claim 12, the combination of Jacquel/Greenspan/Cates discloses the video-based neonatal patient monitoring method of claim 6 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), further comprising:
recording data pertaining to each instance of a breathing event, the type of neonatal patient stimulation initiated in response to the breathing event, and whether the breathing event was terminated in response to the initiated stimulation (Cates: [0070] the display module 45 will display the patient's historical and real-time ventilation status and/or conditions, the patient's historical and real-time level of movement, the patient's historical and real-time SpO2 levels and the patient's historical and real-time prompting protocol cycles and status; [0042] If the patient breathes in response to prompting from the system of the present invention three times in a row, the patient is deemed highly responsive to such prompts and are more likely continue to breathe for a period of time, at least up to 15 minutes, until a caregiver can attend to the patient);
determining that a defined number of breathing events were not terminated by the initiated stimulations; and for subsequently identified breathing events, initiating an alarm in lieu of initiating the neonatal patient stimulation (Cates: [0042] If however, two of the first three prompts provided by the system instructing the patient to breathe are not successful, the system escalates the prompting level to the next higher level. If the highest level of prompting is not successful, the system immediately initiates an alarm condition alerting the care provider that the patient may be experiencing a life-threatening condition; Fig. 8A).
Regarding claim 14, Jacquel teaches a video-based neonatal patient monitoring method (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), comprising: generating depth images from a depth sensing camera having a field of view ([0028] The camera 114 can be a depth sensing camera, … the ROI can be monitored over time, and the changes in depth of regions [e.g., pixels] within the ROI 102 can represent movements of the patient 112 associated with breathing).
However, Jacquel fails to disclose an incubator. Greenspan discloses exposed to an incubator with a neonatal patient (Fig. 1; [0017] In the depicted care setting 100, the patient 104 is located within a controlled environment 106. Such a patient in a controlled environment could, for example, be a neonate located in an incubator of a neonatal intensive care facility.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Jacquel to include an incubator as disclosed in Greenspan to improve health outcomes for infants by maintaining a controlled environment that prevents harsh temperature fluctuations and infection in the health care setting (Greenspan [0024]).
The combination of Jacquel/Greenspan further discloses:
the camera being aligned with the neonatal patient such that at least a portion of the neonatal patient is within the field of view; using changes in the depth images to calculate a neonatal patient breathing parameter (Jacquel: [0027] the video camera 114 of the non-contact detector 110; [0028] The camera 114 can be a depth sensing camera, … the ROI can be monitored over time, and the changes in depth of regions [e.g., pixels] within the ROI 102 can represent movements of the patient 112 associated with breathing … movements, or changes of regions within the ROI 102, can be used to determine various breathing parameters, such as tidal volume, minute volume, respiratory rate, etc; [0032] The captured images/video can be processed or analyzed at the computing device 115 and/or a server to determine a variety of parameters [e.g., tidal volume, minute volume, respiratory rate, etc.] of a patient's breathing.);
monitoring an oxygen saturation level of the neonatal patient to identify the occurrence of a significant desaturation event; monitoring the calculated neonatal patient breathing parameter to identify the occurrence of a breathing event (Greenspan: [0018] respiration parameters (e.g., for apnea) could be monitored by end-tidal CO.sub.2, pulse oximetry and/or thoraco-abdominal motion; [0019] The CPU 110 receives data from the monitoring devices regarding the physiological parameters measured by the devices. The CPU 110 uses the data, preferably through an algorithm, to determine when a condition of the patient 104 requires the application of a corrective measure such a waking stimulus for a patient suffering from sleep apnea. According to one embodiment, the feedback signal of CO.sub.2 from the monitoring devices 108 can be compared to a set point established by a caregiver (i.e., PCO.sub.2=45 mmHg). If the sensed PCO.sub.2 is greater than 40 mmHg (compared to set point) an error signal is sent to the CPU 110. The CPU 110 can then determine the appropriate corrective measure based on the deviation of the monitored parameter from the established set point, for example.).
However, the combination of Jacquel/Greenspan fails to explicitly disclose a response to the simultaneous occurrence of both the breathing event and the significant desaturation event.
The combination of Jacquel/Greenspan/Cates discloses: and in response to the occurrence of both the breathing event and the significant desaturation event, initiating vibration of a stimulation device attached to the incubator (Cates: [0070] If one or more of the ventilation detection module 41, motion detection module, or SpO2 level detection module determine that the patient is not being properly ventilated, the prompting protocol module 44 is triggered… The system 40 is configured to activate the alert module 46 when breath prompting is long lasting or ineffective as determined by the system 40; Fig. 6; Greenspan: [0023] The apparatus includes a stimulus device 116 preferably located within the controlled environment 106 adjacent the patient 104 as shown and adapted to generate a waking stimulus. The waking stimulus could embody any of a variety of forms including audio, visual (e.g., flashing light), physical (e.g., vibrating bed or pillow), and scent. Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Jacquel/Greenspan to include a response to the occurrence of both the breathing event and the significant desaturation event as disclosed in Cates to confirm a life-threatening condition based on low blood-oxygen saturation and lack of motion to cause such patients to self-rescue for a period of time until a care provider can assist the patient (Cates [0039 and 0042]).
Regarding claim 15, the combination of Jacquel/Greenspan/Cates discloses the video-based neonatal patient monitoring method of claim 14 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), further comprising: measuring a duration of the breathing event; and initiating an alarm if the duration of the breathing event exceeds a predetermined length of time (Jacquel: [0062] As shown, the tidal volume signal 999 in the plot 993 is relatively flat for the past 22.5 seconds, suggesting that the patient 112 has not been breathing for approximately that period of time. Cates: [0070] The system 40 is configured to activate the alert module 46 when breath prompting is long lasting or ineffective as determined by the system 40… the display module 45 will display the patient's historical and real-time ventilation status and/or conditions, the patient's historical and real-time level of movement, the patient's historical and real-time SpO2 levels and the patient's historical and real-time prompting protocol cycles and status).
Regarding claim 16, the combination of Jacquel/Greenspan/Cates discloses the video-based neonatal patient monitoring method of claim 14 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), further comprising:
via the depth sensing camera, determining whether the neonatal patient is moving when the breathing event is identified; via the depth sensing camera, determining whether the neonatal patient is moving when the significant desaturation event is identified; initiating a non-critical alarm when patient movement is occurring during either the breathing event or the significant desaturation event (Jacquel: [0028] The camera 114 can be a depth sensing camera, … the ROI can be monitored over time, and the changes in depth of regions [e.g., pixels] within the ROI 102 can represent movements of the patient 112 associated with breathing … movements, or changes of regions within the ROI 102, can be used to determine various breathing parameters, such as tidal volume, minute volume, respiratory rate, etc; Cates: [0070] If one or more of the ventilation detection module 41, motion detection module or SpO2 level detection module determine that the patient is not being properly ventilated, the prompting protocol module 44 is triggered … the prompting protocol module 44 is connected to a speaker to provide audible breathe prompting to the patient and one or more tactile patient stimulation devices to provide tactile stimulation to the patient if audible breath prompting is not sufficient.);
and initiating a critical alarm when patient movement is not occurring during both the breathing event and the significant desaturation event (Cates: [0070] For example, the prompting protocol module will prompt the patient when SpO.sub.2 drops at least 4 percentage points from baseline or below 85% for more than 10 seconds or respiratory rate is less than 6-10 breaths/min. … The system 40 is configured to activate the alert module 46 when breath prompting is long lasting or ineffective as determined by the system 40. Greenspan: [0021] The alarm warning 114 of the present invention has a signature that functions to distinguish the alarm warning 114 from other alarm warnings. In this manner the alarm warning 114 can be adapted to characterize the severity or level of emergency (e.g., yellow, orange, red code levels) and the associated corrective measure that is appropriate to the given level of emergency. For example, the most emergent response, "code red," might be associated with a complete breakdown of respiratory, cardiac and thermal physiological parameters, thus requiring the most immediate and intense response by the caregiver, or in the case of the closed loop system, the maximum system response. ).
Regarding claim 17, the combination of Jacquel/Greenspan/Cates discloses the video-based neonatal patient monitoring method of claim 16 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), wherein the non-critical alarm is changed to a critical alarm when the duration of the significant desaturation event exceeds a predetermined length of time (Cates: [0070] the prompting protocol module 44 is connected to a speaker to provide audible breathe prompting to the patient and one or more tactile patient stimulation devices to provide tactile stimulation to the patient if audible breath prompting is not sufficient. For example, the prompting protocol module will prompt the patient when SpO.sub.2 drops at least 4 percentage points from baseline or below 85% for more than 10 seconds or respiratory rate is less than 6-10 breaths/min. … The system 40 is configured to activate the alert module 46 when breath prompting is long lasting or ineffective as determined by the system 40. Greenspan: [0021] In this manner the alarm warning 114 can be adapted to characterize the severity or level of emergency (e.g., yellow, orange, red code levels) and the associated corrective measure that is appropriate to the given level of emergency.).
Regarding claim 18, the combination of Jacquel/Greenspan/Cates discloses the video-based neonatal patient monitoring method of claim 14 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), wherein monitoring the oxygen saturation level of the neonatal patient to identify the occurrence of a significant desaturation event is performed only after the occurrence of a breathing event has been identified (Cates: Fig. 8A [in the first round of checks at the top of the figure, SpO2 is checked only AFTER the breathing parameter is checked]).
Regarding claim 19, the combination of Jacquel/Greenspan/Cates discloses the video-based neonatal patient monitoring method of claim 14 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), wherein monitoring the calculated neonatal patient breathing parameter to identify the occurrence of a breathing event is performed only after the occurrence of a significant desaturation event has been identified (Cates: Fig. 8A [the breathing parameter of the 2nd round is only checked AFTER the SpO2 check of the 1st round]).
Regarding claim 20, the combination of Jacquel/Greenspan/Cates discloses the video-based neonatal patient monitoring method of claim 14 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), wherein the breathing event comprises apnea (Jacquel: [0046] detect a variety of medical conditions, such as apnea, rapid breathing [tachypnea], slow breathing, intermittent or irregular breathing, shallow breathing, and others; Fig. 9; [0088] if a patient's respiratory rate is and/or drops below a predetermined respiratory rate threshold value and/or range, the routine 1100 can determine that the patient is not breathing, that the patient is exhibiting apnea, and/or that the patient's breathing is restricted and/or impaired).
Regarding claim 21, the combination of Jacquel/Greenspan/Cates discloses the video-based neonatal patient monitoring method of claim 14 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), wherein the oxygen saturation level of the neonatal patient is obtained using a pulse oximeter attached to the neonatal patient (Greenspan: [0018] respiration parameters (e.g., for apnea) could be monitored by end-tidal CO.sub.2, pulse oximetry and/or thoraco-abdominal motion; Cates: [0071] the system 10 further includes a finger pulse oximeter 28; Fig. 1).
Regarding claim 22, the combination of Jacquel/Greenspan/Cates discloses the video-based neonatal patient monitoring method of claim 14 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes), wherein the neonatal patient stimulation further includes one or more of: an auditory signal, a visual signal, or puffs of air stimulation (Jacquel: [0063] if the system detects a breathing abnormality, the system can trigger an audio and/or visual alarm to alert a user [e.g., the patient, the caregiver, the clinician, etc.]. Greenspan: [0023] The waking stimulus could embody any of a variety of forms including audio, visual (e.g., flashing light), physical (e.g., vibrating bed or pillow), and scent.).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jacquel (US 20200046302 A1) in view of Greenspan (US 20100056879 A1), and in further view of Kirenko (US 20170169691 A1).
Regarding claim 10, the combination of Jacquel/Greenspan discloses the video-based neonatal patient monitoring method of claim 1 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes). However, the combination of Jacquel/Greenspan fails to disclose recognizing the presence of a caregiver.
Kirenko teaches a system, method and computer program for detecting a movement and/or a position of a baby to be monitored. Kirenko discloses, further comprising: recognizing a presence of a caregiver in the field of view; and preventing initiation of the neonatal patient stimulation when the caregiver is determined to be in the field of view ([0090] the system is further configured to detect the presence of a caregiver 7 in the vicinity of the person 1 or the laying area 3. And, if a caregiver's presence is detected, the initiation of the alarm routine may be deactivated. [0096] motion of the baby is detected when the area of the lying area 3 obscured by the baby lying thereon changes).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Jacquel/Greenspan to include determining the presence of a caregiver as disclosed in Kirenko to prevent the initiation of the alarm when the alarm is not necessary (Kirenko [0027]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jacquel (US 20200046302 A1) in view of Greenspan (US 20100056879 A1), and in further view of Abbas (US 20200338337 A1).
Regarding claim 13, the combination of Jacquel/Greenspan discloses the video-based neonatal monitoring method of claim 1 (Jacquel: [0026] video-based detection and/or monitoring of breathing in … neonatal individuals within their homes). However, the combination of Jacquel/Greenspan fails to disclose non-periodic stimulation.
Abbas teaches a non-invasive intraoral neurostimulation device and method for treating obstructive sleep apnea. The combination of Jacquel/Greenspan/Abbas discloses wherein the neonatal patient stimulation comprises a non-periodic sequence of vibration (Abbas: [0068] The intraoral neurostimulation device 102 may be configured to regulate the rate of stimulation, such as to stimulate on every inhale, stimulate only during apneic episodes, etc. Greenspan: [0023] The waking stimulus could embody any of a variety of forms including audio, visual (e.g., flashing light), physical (e.g., vibrating bed or pillow), and scent.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Jacquel/Greenspan to include non-periodic stimulation as disclosed in Abbas to reduce the total amount of stimulation time to an estimated 1-4 minutes per night for extreme cases of obstructive sleep apnea (Abbas [0068]).
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 MOLLY HALPRIN whose telephone number is (703)756-1520. The examiner can normally be reached 12PM-8PM ET.
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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