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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 19, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on November 27, 2024 are accepted.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1-9 are drawn to a “system” which describes one of the four statutory categories, i.e., a machine.
Claim 10-18 is directed to a “method” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Claims 19-20 are directed to an “device” which describes one of the four statutory categories of patentable subject matter, i.e., a machine.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claims 1, 10 and 19 recite (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), substantially as follows: detect, based on the sensor signal, a stroke event.
In claims 1 and 16, the above recited steps can be practically performed in the human mind, with the aid of a pen and paper. If a person were to visually examine, i.e., perform an observation, the sensor signal, he/she would be able to identify a stroke event based on, for example, the pattern of the sensor signal, or a comparison to a look up table or a reference pattern. There is nothing recited in the claim to suggest an undue level of complexity in how the stroke event is determined based on the sensor signal. Therefore, a person would be able to perform the detection mentally.
Prong Two: Claims 1 and 14 do not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, the claims recites additional steps of (1) a contactless sensor or a Doppler sensor configured to generate a sensor signal indicative of a breathing pattern, (2) processing circuitry configured to receive the sensor signal, (3) processing circuitry configured to generate a notification indicative of the stroke event, and for claim 19: (4) a housing securing the Doppler sensor and the processing circuitry.
The steps in (1) and (2) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (i.e., the contactless sensor or the Doppler sensor, and the processing circuitry).
The step in (3) represents merely notification outputting by a processor as a post-solution activity and is recited at a high level of generality with conventionally used tools (i.e., the processing circuitry).
The step in (4) represents merely a configuration of the tool that is used for data collection, and such a configuration is well-known, routine and conventional (i.e., the housing).
In regard to the processing circuitry, a claim that requires computer may still recite a mental process. MPEP 2106.04(a)(2).III.C.: Performing a mental process on a generic computer, in a computer environment, or using a computer as a tool to perform the steps are considered a mental process.
As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to output a notification based on the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the detected stroke event is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1, 10 and 19 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of (1) a contactless sensor or a Doppler sensor configured to generate a sensor signal indicative of a breathing pattern, (2) processing circuitry configured to receive the sensor signal, (3) processing circuitry configured to generate a notification indicative of the stroke event, and for claim 19: (4) a housing securing the Doppler sensor and the processing circuitry.
These steps represents mere data gathering, data outputting or pre/post/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality. For similar reasons set forth in Step 2A, Prong Two above, the additional elements of the contactless sensor or the Doppler sensor with a housing, and the processing circuitry, that are used to perform these steps do not provide an inventive concept under Step 2B.
Accordingly, these additional steps amount to no more than insignificant conventional extra-solution activity. Mere insignificant conventional extra-solution activity cannot provide an inventive concept. The claims hence are not patent eligible.
Dependent Claims
The following dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons:
Describe further in regard to how the stroke event is detected yet nothing recited in the claim to suggest an undue level of complexity (claims 2-5 and 12-15)
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons:
describing the type of the contactless sensor being a Doppler sensor, its operational principle and its configuration (claim 6-7, 9 and 11, 16) – claims 6 and 9 are addressed in the consideration for claim 19. Claim 11 is addressed in the consideration for claim 1. Claims 7 and 16 recite the operational principle of a Doppler sensor that is well-known as taught in Antonelli, [0032];
describing further extra-solution activity to transmit the notification to a remote system and further describe the types of the remote system, and an output device (claims 8, 17-18 and 20) that is insignificant as taught in Strasser, [0148];
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
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 1-6, 8, 10-15 and 17-18 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 and 10. Tsuji teaches in FIG.1 a system and a method, comprising:
a contactless 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); 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 sensor signal is processed and based on which a stroke event is detected, 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 (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, 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 2-5 and 12-15. Panteleon further teaches
determine, based on the sensor signal, the breathing pattern, and detect, based on the breathing pattern, the stroke event (claims 2 and 12); determine, based on the breathing pattern, an irregular breathing event, and detect, based on the irregular breathing event, the stroke event (claims 3 and 13); 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 9SCR) 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 6 and 16. Tsuji further teaches that
the contactless sensor comprises a Doppler sensor ([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).
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 7, 9, 16 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.
Claims 7 and 16. Tsuji, Panteleon and Strasser combined teaches all the limitations of claims 1 and 10, including the feature of using a Doppler sensor for determining a breathing pattern based on which a stroke event is detected (Tsuji: [0024], [0030], FIG.1, and Panteleon: [0004]).
The claimed feature is the nature of the Doppler effect, for which, in an analogous Doppler sensor field of endeavor, Antonelli teaches
transmit a first energy signal toward the patient, receive a second energy signal generated by a reflection of the first energy signal by the patient, determine, by comparing the first energy signal and the second energy signal, a Doppler shift indicative of the breathing pattern of the patient, and wherein the sensor signal is indicative of the Doppler shift (Abstract: the invention as disclosed is a non-contact method and apparatus for continuously monitoring a physiological event in a human or animal…in combination with a laser tracking system and a signal processor to produce a waveform that is representative of a continuous physiological event such as…respiration in a subject; and [0032]: The reflected laser light beam 34 is modulated by the movement of skin surface 26 by means of a Doppler shift in the optical wavelength, as compared to the original laser beam 32 processed by laser source 14. Detector 18 generates a signal corresponding to the velocity of the pulsatile skin motion as derived from the Doppler shift).
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 features associated with “transmit a first energy signal toward the patient, receive a second energy signal generated by a reflection of the first energy signal by the patient, determine, by comparing the first energy signal and the second energy signal, a Doppler shift indicative of the breathing pattern of the patient, and wherein the sensor signal is indicative of the Doppler shift” as taught in Antonelli for the advantage of providing an explicit teaching of the principle of a Doppler effect.
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 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);
processing circuitry (FIG.2, 14a, 15) configured to
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 sensor signal is received and processed such that based on which a stroke event is detected, 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 9SCR) 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).
Conclusion
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