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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/30/26 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9, 11 and 13-20 have been considered but are moot because the new ground of rejection.
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, 8, 11, 13-14, 16-17 and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rahman et al. (U.S. Pub. 2021/0386318 hereinafter “Rahman”) in view of Robinson et al. (U.S. Pub. 2020/0288985 hereinafter “Robinson”) and Lee et al. (U.S. Pub. 2017/0014079 hereinafter “Lee”).
Regarding claims 1 and 13, Rahman discloses a system for assessing pulmonary health, the system comprising: a handheld electronic device (HED) (e.g. 100) including a display screen (e.g. ¶78), a processor (e.g. 112), and a software application (e.g. ¶24); a casing (e.g. 200) comprising: a plurality of ECG electrodes placed on an outer surface of the casing (e.g. ¶120); at least one microcontroller (e.g. 112); at least one sound transducer configured to capture pulmonary signals indicative of pulmonary health (e.g. ¶115); at least one Inertial Measurement Unit (IMU) sensor configured to capture seismic and gyroscope signals indicative of the pulmonary health of a user and an orientation of the casing (e.g. ¶¶22, 115); at least one circuit board disposed within the casing and electrically connected with the plurality of ECG electrodes, the at least one microcontroller, the at least one sound transducer, and the at least one IMU sensor (e.g. ¶¶104, 106), wherein the at least one microcontroller is configured to transmit data received from the plurality of ECG electrodes, the at least one sound transducer, and the at least one IMU sensor to at least one of the HED and a computing device, wherein at least one of the HED and a computing device is configured to (e.g. see Fig. 2): receive, data from the at least one IMU sensor, and the at least one sound transducer (e.g. ¶¶ 22, 23, 115); detect features based on sound data from the at least one sound transducer and movement data from the at least one IMU sensor (e.g. ¶¶ 22, 23, 115); identify patterns in the detected features based on at least one of a classification model and a regression model (e.g. ¶153); and using the identified patterns, calculate at least one of a probability of whether the identified patterns correspond to clinically relevant indicators of a pulmonary health condition of the user and an estimate of a progression of the pulmonary health condition (e.g. ¶¶ 46-49 and 73). Rahman discloses the claimed ECG case but fails to disclose the case further containing the ECG electrodes on the surface and an Inertial Measurement Unit and a diaphragm to enhance the microphone signals. However, Robinson discloses a similar device (e.g. ¶78) wherein the device case further includes electrodes on the surface of the housing (e.g. ¶¶242-256), an inertial measurement unit (e.g. ¶248) and a diaphragm to enhance audio signal (e.g. ¶259) to include all of the sensors within the device to monitor physiological and pulmonary health. Robinson further discloses that the system receives data from the sound transducer and IMU sensor when the casing is positioned against the thoracic cavity (e.g. ¶¶242-254; Figure 43). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Rahman, with the multiple sensors and housing configurations as taught by Robinson, since such a modification would provide the predictable results of a device with all of the sensors needed for providing effective health sensing without the need for multiple devices. Rahman in view of Robinson discloses the claimed invention except for explicitly stating that the system senses pulmonary activity when the sound sensor is positioned against the thoracic cavity. However, Lee teaches that it is known to use a stethoscope diaphragm with the microphone to enhance sounds from the microphone when positioned against the thoracic cavity as taught in Figures 1B, 1C, 2B, 2C and Paragraphs 14, 88, 93 and 111 to sense and record pulmonary data. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Rahman in view of Robinson, with the microphone system for sensing pulmonary activity as taught by Lee for sensing all signals from the microphone, since such a modification would provide the system with a diaphragm to enhance the audio quality of the microphone when sensing sounds for analysis of a patients pulmonary activity to assess the health of the patient using a handheld device.
Regarding claim 2, meeting the limitations of claim 1 above, Rahman further discloses a second electronic device wearable by the user, wirelessly connected with the HED, wherein the second electronic device comprises (e.g. ¶30): one or more sensors configured to collect health data from the user (e.g. 114); and a wireless transceiver configured to establish a communication between the second electronic device and the computing device to transmit health data therebetween, wherein the computing device is further configured to (e.g. ¶20): detect, based on the classification model, a presence of the indicators of the pulmonary health condition (e.g. ¶153), and estimate, using the clinically relevant indicators of the pulmonary health condition, based on the regression model, a severity of the pulmonary health condition (e.g. ¶¶47, 48 and 73).
Regarding claims 3 and 14, meeting the limitations of claim 1 above, Rahman further discloses wherein the at least one sound transducer is configured to emit soundwaves into a thoracic region of the user (e.g. ¶86).
Regarding claim 4 and 16, meeting the limitations of claim 1 above, Rahman further discloses wherein the processor is configured to present to the user one or more commands to determine a positioning of the casing on a user's body (e.g. ¶79).
Regarding claims 5 and 17, meeting the limitations of claim 1 above, Rahman further discloses wherein the classification model is trained to classify an unhealthy lung caused by pulmonary congestion (e.g. ¶¶ 22, 49 and 82).
Regarding claims 8 and 20, meeting the limitations of claim 1 above, Rahman further discloses wherein the HED further comprises a battery configured to supply electrical power to the at least one circuit board (e.g. ¶112).
Regarding claim 11, meeting the limitations of claim 1 above, Rahman further discloses wherein the casing has a shape adapted to secure the HED to the casing or the casing is integrated with the HED (e.g. see Fig. 2).
Claim 6 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rahman in view of Robinson as applied to claims 1-5, 8, 11-14, 16-17 and 20 above, and further in view of Ser et al. (U.S. Pub. 2015/0190091 hereinafter “Ser”).
Regarding claims 6 and 18, Rahman in view of Robinson discloses the claimed invention except for the system being trained based on lung fluid levels for classifying lung diseases and congestion. However, Ser teaches that it is known to use multiple handheld devices as set forth in Paragraphs 36, 115-116 and Clam 1 to provide a means for accurately determining lung diseases and congestion. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the training model as taught by Rahman in view of Robinson, with multiple sensors as taught by Ser, since such a modification would provide the predictable results of using multiple sensors in multiple areas to help aid in the early detection of lung diseases and congestion.
Claims 7 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rahman in view of Robinson as applied to claims 1-5, 8, 11-14, 16-17 and 20 above, and further in view of Sieniek (U.S. Pub. 2020/0225811).
Regarding claims 7 and 19, Rahman in view of Robinson discloses the claimed invention except for the model being trained with CT and X-ray data. However, Sieniek teaches that it is known to use CT and X-ray data as set forth in Paragraphs 7, 9 and 23 to provide a means for accurately determining pulmonary cancer and other diseases. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the training model as taught by Rahman in view of Robinson, with a model trained from CT and X-rays as taught by Sieniek, since such a modification would provide the predictable results of training the classification model with multivariate data from CT and X-rays for providing data to help aid in the detection of pulmonary cancer and diseases.
Claims 9 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rahman in view of Robinson as applied to claims 1-5, 8, 11-14, 16-17 and 20 above, and further in view of Varadan et al. (U.S. Pub. 2017/0354372 hereinafter “Varadan”).
Regarding claims 9 and 15, Rahman in view of Robinson discloses the claimed invention except for explicitly stating that the system senses temperature and alerts a healthcare professional if there are any severe health conditions detected. However, Varadan teaches that it is known to use temperature sensors along with wireless message transmission as set forth in Paragraphs 84 and 104 to provide a means for sensing and then alerting clinicians of a deterioration that would otherwise go unnoticed. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Rahman in view of Robinson, with temperature sensors along with wireless message transmission as taught by Varadan, since such a modification would provide the predictable results of sensing temperature and pulmonary data and then alerting clinicians of a deterioration that would otherwise go unnoticed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached on Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/Primary Examiner, Art Unit 3792
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