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 Arguments
Applicant’s arguments, see Remarks, filed 10/17/25, with respect to the rejection(s) of claim(s) 1-22 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rahman et al. (U.S. Pub. 2021/0386318 hereinafter “Rahman”).
Claim Objections
Claim 12 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 3. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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, 11-14, 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”).
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 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 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. 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 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.
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).
Regarding claim 12, 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).
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
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REX R HOLMES/Primary Examiner, Art Unit 3792