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 .
DETAILED ACTION
The amendment filed on June 10, 2026 is acknowledged and entered. Claims 1, 10, 14, 16 and 19 are amended. Claims 2-3, 6-7 and 12-13 are canceled. Claims 1, 4-5, 8-11 and 14-20 are pending and under examination in this Office action.
Response to Amendment
The rejection to claims 1-20 under 35 U.S.C. 101 is now withdrawn in view of the claim amendment.
The rejections to the pending claims under 35 U.S.C. 103 are withdrawn in view of the claim amendment. A new ground of rejection is now made to the independent claims using the same prior arts cited previously.
Examiner’s Notes – claim interpretation
In claims 1, 10 and 19, the claims recite “detect a stroke event”. A stroke is a brain injury due to its blood supply interruption. Though the occurrence of a stroke is reflected in many physiological symptoms, such as abnormal breathing pattern, having an abnormal breathing pattern does not necessarily indicate an occurrence of a stroke. As disclosed in the specification and recited in the claim, the sensor is a contactless sensor. A contactless sensor may be capable of detecting abnormal breathing patter, the specification does not disclose that it is capable of identify the actual brain injury. As such, the recited limitation of “detect a stroke event” is interpreted as detecting an event that may be indicative of a stroke. In other words, the “stroke event” recited in the claims is considered an event that may be indicative of a stroke, rather than identifying the brain injury.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4-5, 8, 10-11 and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tsuji et al., US 2018/0322334 A1, hereinafter Tsuji, in view of Panteleon et al., US 2022/0248978 A1, hereinafter Panteleon, further in view of Strasser et al., US 2025/0281116 A1, hereinafter Strasser.
Claims 1, 10, 11 and 16. Tsuji teaches in FIG.1 a system and a method, comprising:
a contactless Doppler sensor configured to generate a sensor signal indicative of a breathing pattern of a patient ([0024]: as shown in FIG.1, a subject observation system MSa includes one or more sensor units SUa (SUa-1 to SUa-4); and [0030]: The SU control processing section 14a obtains a chest motion (i.e., shrinking and bulging motion of a chest) of the subject Ob who is breathing on the basis of the Doppler signal from the Doppler sensor, and judges the chest motion as the abnormally irregular motion when inspecting a disorder in the cycle of the chest motion or an amplitude indicating a predetermined threshold or smaller in the chest motion) by:
transmitting a first energy signal toward the patient; receiving a second energy signal generated by a reflection of the first energy signal by the patient; determining, by comparing the first energy signal and the second energy signal, a Doppler shift between the first energy signal and the second energy signal ([0030]: the Doppler sensor sends a transmission wave, receives a reflection wave of the transmission wave that is reflected from the object, and outputs a Doppler signal of a Doppler frequency component based on the transmission wave and the reflection wave. The frequency of the reflection wave shifts in proportion to a moving speed of the object during movement of the object owing to the Doppler effect, which cases a difference (Doppler frequency component) between the frequency of the transmission wave and the frequency of the reflection wave);
generating the sensor signal indicative of the breathing pattern based on the Doppler shift ([0030]: The SU control processing section 14a obtains a chest motion (i.e., shrinking and bulging motion of a chest) of the subject Ob who is breathing on the basis of the Doppler signal from the Doppler sensor, and judges the chest motion as the abnormally irregular motion when inspecting a disorder in the cycle of the chest motion or an amplitude indicating a predetermined threshold or smaller in the chest motion) – the abnormally irregular chest motion at breathing is considered an indicative of an abnormally irregular breathing pattern;
processing circuitry (FIG.2, 14a, 15) configured to: receive the sensor signal, detect, based on the sensor signal, at least one characteristic of the sensor signal associated with an irregularity in the breathing pattern (claim 1: a hardware processor including an abnormality determination part which determines based on the predetermined movement of the subject detected by the first detector and the specified parameter stored in the parameter information storage whether or not the predetermined movement of the subject indicates the abnormality; and [0030]: The SU control processing section 14a obtains a chest motion (i.e., shrinking and bulging motion of a chest) of the subject Ob who is breathing on the basis of the Doppler signal from the Doppler sensor, and judges the chest motion as the abnormally irregular motion when inspecting a disorder in the cycle of the chest motion or an amplitude indicating a predetermined threshold or smaller in the chest motion) – at least the amplitude or the disorder in the cycle is the “at least one characteristic of the sensor signal” as claimed; and
generate a notification indicative of the breathing pattern being abnormal ([0050]: the stationary terminal device SP…further serves as a user interface (UI) of the subject observation system MSa by inputting the predetermined instruction or data to be given to the administration server SV or the mobile terminal device TA, displaying the abnormality of the subject Ob).
Tsuji does not teach that the irregularity in the beathing pattern is indicative of the stroke event, and the notification is in regard to the indication of the stroke event.
However, in an analogous chest motion based breathing pattern analysis field of endeavor, Panteleon teaches
the irregularity in the beathing pattern is indicative of the stroke event, and the notification is in regard to the indication of the stroke event ([0004]: disordered breathing describes a variety of observable respiration patterns that deviate from abnormal respiration. For example, Cheyne-Stokes respiration (CSR) is clinically observed and declared when a patient has bouts of “rapid” and/or “deep” breathing followed by reductions in breathing or apnea-hypopnea. This abnormal pattern of breathing can be seen in patients with strokes) – a stroke event is interpreted, as indicated in the Examiner’s Notes, as an event that is indicative of a stroke such as an abnormal respiration or an abnormal pattern that may be indicative of a stroke. The rapid and/or deep breathing followed by reductions in breathing is considered the “irregularity in the breathing pattern” as claimed, and
generate a notification indicative of the abnormal event ([0006]: computing device configured with the applications, and computer-implemented methods to provide user interfaces on the mobile computing devices to aid user monitoring of a disordered breathing treatment…The method includes providing, by the application running the user computing device ,a diagnostic report and monitoring screen fo the GUI on the display device…one or more graphical illustrations of respiratory sensing data for the selected patient, one or more graphical illustrations of synchronized respiratory activity data for the selected patient, and graphical representations of periodic breathing data for the patient. In some embodiments, breathing data for the patient can include data from measured signals representing patient snore sounds, patient chest movement, patient O2/desaturation, and so forth).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system, the method and the device of Tsuji employ such features associated with “receive the sensor signal, detect, based on the sensor signal, a stroke event; and generate a notification indicative of the abnormal event” as taught in Panteleon for the advantage of “to aid user monitoring of a disordered breathing treatment”, as suggested in Panteleon, [0006].
Neither Tsuji nor Panteleon teaches that the notification is indicative of the stroke event generated in response to the stroke event.
However, in an analogous Doppler-based stroke even detection field of endeavor, Strasser teaches
generate, in response to the stroke event, a notification indicative of the stroke event ([0148]: a system for stroke detection may include one or more Doppler radar sensors…to detect visual signs of stroke; and [0217]: the device may trigger indicators, information, messages, and/or warnings to be presented to the user of device or to be presented to another device communicably coupled to device 400).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system, the method and the device of Tsuji and Panteleon combined employ such a feature of “generate, in response to the stroke event, a notification indicative of the stroke event” as taught in Strasser for the conventionally-acknowledged advantage of a warning sign for properly signaling the user with critical information.
Claims 4-5 and 14-15. Panteleon further teaches
the breathing pattern is indicative of a Cheyne-Stokes breathing event (claims 4 and 14); and the stroke event comprises a prediction of stroke, an onset of stroke, an ongoing stroke, or a ceased stroke (claims 5 and 15) ([0004]: disordered breathing describes a variety of observable respiration patterns that deviate from abnormal respiration. For example, Cheyne-Stokes respiration (SCR) is clinically observed and declared when a patient has bouts of “rapid” and/or “deep” breathing followed by reductions in breathing or apnea-hypopnea. This abnormal pattern of breathing can be seen in patients with strokes; and [0006]: respiratory sensing data for the selected patient) – “patients with strokes” refers to either the onset of the stroke or the ongoing stroke.
Claims 8 and 17. Strasser further teaches
transmit the notification to a remote system ([0148]: a system for stroke detection may include one or more Doppler radar sensors…to detect visual signs of stroke; and [0217]: the device may trigger indicators, information, messages, and/or warnings to be presented to the user of device or to be presented to another device communicably coupled to device 400; FIG.1B: various devices communicate wirelessly).
Claim 18. Strasser further teaches that
the remote system comprises a computing device, an emergency response system, a first responder system, or a clinical system (FIG.1B: the stroke notification is sent to an operator for calling HCP for EMT and/or RN/PAP/Specialist’s attention).
Claims 9 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tsuji et al., US 2015/0135840 A1, hereinafter Tsuji, in view of Panteleon et al., US 2022/0248978 A1, hereinafter Panteleon, further in view of Strasser et al., US 2025/0281116 A1, hereinafter Strasser, further in view of Antonelli et al., US 2009/0199197 A1, hereinafter Antonelli.
Claim 9. Tsuji, Panteleon and Strasser combined teaches all the limitations of claim 1.
Tsuji in FIG.1 teaches that the contactless sensor is comprised in a housing (FIG.1: the SUa-1 to SUa-4 are illustrated as being enclosed in a housing since the sensing components and circuitry are not illustrated to be exposed).
Alternatively, if Tsuji is considered not providing a sufficient and explicit teaching for the claimed feature of the housing, in an analogous contactless sensor configuration field of endeavor, Antonelli teaches
a housing comprising the contactless sensor ([0040]: all of the components of the laser Doppler vibrometer 12, including the laser source, the lens, and the detector, are preferably built into a single housing).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system and method of Tsuji, Panteleon and Strasser combined employ such a feature of “a housing comprising the contactless sensor” as taught in Antonelli for the advantage of providing an appropriate enclosure for the sensing components to ensure the integrity and the operational safety of the sensor.
Claim 19. Tsuji teaches in FIG.4 a sleep monitoring device comprising:
a contactless Doppler sensor configured to generate a sensor signal indicative of a breathing pattern of a patient based on a Doppler shift ([0024]: as shown in FIG.1, a subject observation system MSa includes one or more sensor units SUa (Sua-1 to Sua-4); and [0030]: the Doppler sensor sends a transmission wave, receives a reflection wave of the transmission wave that is reflected from the object, and outputs a Doppler signal of a Doppler frequency component based on the transmission wave and the reflection wave. The frequency of the reflection wave shifts in proportion to a moving speed of the object during movement of the object owing to the Doppler effect, which cases a difference (Doppler frequency component) between the frequency of the transmission wave and the frequency of the reflection wave…The SU control processing section 14a obtains a chest motion (i.e., shrinking and bulging motion of a chest) of the subject Ob who is breathing on the basis of the Doppler signal from the Doppler sensor, and judges the chest motion as the abnormally irregular motion when inspecting a disorder in the cycle of the chest motion or an amplitude indicating a predetermined threshold or smaller in the chest motion);
processing circuitry (FIG.2, 14a, 15) configured to
receive the sensor signal; detect, based on the sensor signal, at least one characteristic of the sensor signal associated with an irregularity in the beathing pattern (claim 1: a hardware processor including an abnormality determination part which determines based on the predetermined movement of the subject detected by the first detector and the specified parameter stored in the parameter information storage whether or not the predetermined movement of the subject indicates the abnormality; and [0030]: The SU control processing section 14a obtains a chest motion (i.e., shrinking and bulging motion of a chest) of the subject Ob who is breathing on the basis of the Doppler signal from the Doppler sensor, and judges the chest motion as the abnormally irregular motion when inspecting a disorder in the cycle of the chest motion or an amplitude indicating a predetermined threshold or smaller in the chest motion) – the abnormally irregular chest motion at breathing is considered an indicative of an abnormally irregular breathing pattern. At least the amplitude or the disorder in the cycle is the “at least one characteristic of the sensor signal” as claimed); and
generate a notification indicative of the breathing pattern being abnormal ([0050]: the stationary terminal device SP…further serves as a user interface (UI) of the subject observation system MSa by inputting the predetermined instruction or data to be given to the administration server SV or the mobile terminal device TA, displaying the abnormality of the subject Ob); and
a housing securing the Doppler sensor and the processing circuitry (FIG.1: the SUa-1 to SUa-4 are illustrated as being enclosed in a housing since the sensing components and circuitry are not illustrated to be exposed)
Tsuji does not teach that the irregularity in the beathing pattern is indicative of the stroke event, and the notification is in regard to the indication of the stroke event.
However, in an analogous chest motion based breathing pattern analysis field of endeavor, Panteleon teaches
processing circuitry configured to: receive the sensor signal, detect, based on the sensor signal, a stroke event ([0004]: disordered breathing describes a variety of observable respiration patterns that deviate from abnormal respiration. For example, Cheyne-Stokes respiration (SCR) is clinically observed and declared when a patient has bouts of “rapid” and/or “deep” breathing followed by reductions in breathing or apnea-hypopnea. This abnormal pattern of breathing can be seen in patients with strokes), and
generate a notification indicative of the abnormal event ([0006]: computing device configured with the applications, and computer-implemented methods to provide user interfaces on the mobile computing devices to aid user monitoring of a disordered breathing treatment…The method includes providing, by the application running the user computing device ,a diagnostic report and monitoring screen fo the GUI on the display device…one or more graphical illustrations of respiratory sensing data for the selected patient, one or more graphical illustrations of synchronized respiratory activity data for the selected patient, and graphical representations of periodic breathing data for the patient. In some embodiments, breathing data for the patient can include data from measured signals representing patient snore sounds, patient chest movement, patient O2/desaturation, and so forth).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system, the method and the device of Tsuji employ such features associated with “receive the sensor signal, detect, based on the sensor signal, a stroke event; and generate a notification indicative of the abnormal event” as taught in Panteleon for the advantage of “to aid user monitoring of a disordered breathing treatment”, as suggested in Panteleon, [0006].
Neither Tsuji nor Panteleon teaches that the notification is indicative of the stroke event generated in response to the stroke event.
However, in an analogous Doppler-based stroke even detection field of endeavor, Strasser teaches
generate, in response to the stroke event, a notification indicative of the stroke event ([0148]: a system for stroke detection may include one or more Doppler radar sensors…to detect visual signs of stroke; and [0217]: the device may trigger indicators, information, messages, and/or warnings to be presented to the user of device or to be presented to another device communicably coupled to device 400).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system, the method and the device of Tsuji and Panteleon combined employ such a feature of “generate, in response to the stroke event, a notification indicative of the stroke event” as taught in Strasser for the conventionally-acknowledged advantage of a warning sign for properly signaling the user with critical information.
In regard to the housing, alternatively, if Tsuji, Panteleon and Strasser combined is considered not providing a sufficient and explicit teaching for the claimed feature of the housing, in an analogous contactless sensor configuration field of endeavor, Antonelli teaches
a housing comprising the contactless sensor ([0040]: all of the components of the laser Doppler vibrometer 12, including the laser source, the lens, and the detector, are preferably built into a single housing).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system and method of Tsuji, Panteleon and Strasser combined employ such a feature of “a housing comprising the contactless sensor” as taught in Antonelli for the advantage of providing an appropriate enclosure for the sensing components to ensure the integrity and the operational safety of the sensor.
Claim 20. Strasser further teaches
an output device configured to generate an output in response to the notification (FIG.1A: the DATA panel, the App has a display that generates an output).
Response to Arguments
Applicant’s arguments in regard to the rejection under 35 U.S.C. 103 have been fully considered but they are not persuasive.
In view of the claim amendment, it is determined that the amendment has changed the scope of the claim. The previous rejection is therefore withdrawn. A new ground of rejection is now made to the independent claims. In the new ground of rejection, it is determined that the previously cited Tsuji, Panteleon and Strasser combined remains providing appropriate and sufficient teaching to claims 1, 10 and 19, including the amended features, with the additionally cited prior art Antonelli being relied upon for the teaching of the housing feature recited in claim 19.
Examiner’s interpretation in regard to “detect a stroke event” as noted in the Office action before the rejection section still stands.
In the new ground of rejection, Tsuji teaches in [0030] the principle of Doppler shift and the resultant sensor signal being processed to detect a breathing pattern, or more specifically an abnormally irregular breathing pattern. Panteleon is relied upon for the teaching that an abnormally irregular breathing pattern is an indicative of a stroke event.
In regard to the asserted feature of “detect, based on the sensor signal, a stroke event by determining at least one characteristic of the sensor signal associated with an irregularity in the breathing pattern indicative of the stroke event”, Examiner respectfully notes that, in the rejection, Tsuji teaches using a Doppler technique, in particular a Doppler effect or a Doppler shift on the differential frequency components of the transmission wave and the reflection wave, to detect an abnormal or irregular chest motion from breathing based on the amplitude or whether there is a disorder in a respiratory cycle. Panteleon further teaches that “an abnormal pattern of breathing can be seen in patients with strokes”. Hence, the combined teaching of Tsuji and Panteleon is considered appropriate and sufficient to read on the above identified asserted feature.
Applicant has argued in the Remarks, p.10 that “nothing in Panteleon specifically discloses or suggests detecting a stroke event based on a sensor signal,…Panteleon does not disclose or suggest determining at least one characteristic associated with an irregularity in a breathing pattern indicative of a stroke event…Panteleon acknowledges that are a number of conditions, such as traumatic brain injuries and brain tumors, associated with CSR, which are not in themselves indicative of stroke events”; further on p.11: “Panteleon’s assessment of breathing is based on parameters such as “impedance”…which is relevant to neither contactless sensors or stroke”. Further Applicant asserted that Strasser does not teach or suggest the determining feature either.
Examiner respectfully disagrees based on the above considerations. In the new ground of rejection, Tsuji is relied upon for the Doppler shift sensing and the analysis of the signals to determine an abnormal chest movement associated with breathing. Panteleon is relied upon for the teaching of an abnormal breathing patten “can be seen in patient’s with strokes”. This teaching, along with Examiner’s interpretation about “detect a stroke event”, is interpreted to be an indicative of a stroke event. Neither Panteleon nor Strasser is relied upon in the new ground of rejection for the teaching of “determining at least one characteristic of the [Doppler] sensor signal associated with an irregularity in the breathing pattern”.
Based on the above considerations, claims 1, 4-5, 8-11 and 14-20 remain rejected.
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 YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
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