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 .
Claim Status: Claims 1-11 and 13-19 are pending.
Response to Arguments
With respect to 101 rejection, Applicant’s arguments have been considered and found persuasive. Therefore, the 101 rejections have been withdrawn.
Applicant’s arguments with respect to claims 1 and 16 regarding Song reference have been considered but are moot because the new grounds of rejection have been made necessitated by amendments.
Regarding Applicant’s argument about acoustic electrodes, Song discloses using acoustic sensors to measure heart sounds (para. [0035], [0038]). It should be clear to one of ordinary skill in the art how acoustic sensors work to measure sounds.
Applicant's arguments with respect to claims 1 and 16 regarding Bang reference have been fully considered but they are not persuasive.
Applicant made an argument that para. [050] and [064] describe continuous monitoring of a patient but does not teach or suggest how long the device can perform such monitoring. Applicant also argued that while para. [094] of Bang describes how disposable devices may be worn by the user for 3 days or one week, the reference does not provide any teaching or suggestion that the device is actually performing continuous monitoring during this entire time.
These arguments have been considered but are not persuasive.
Bang discloses analysis of trending data and/or pattern recognition over days, months, and/or years of one or more patient vital signs (para. [069]), where the system can analyze heartbeat data that are recorded over days, weeks, months and/or years to identify subtle changes using machine learning and trending analysis (para. [071], [113]). Therefore, the device is used for continuous monitoring for a plurality of days.
Allowable Subject Matter
Claims 6-11 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Amendment
With respect to claim objection, Applicant’s amendment has overcome each and every objection.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bang et al. (WO 2020/243463A1).
Examiner note: These grounds of rejection are given in order to address dependent claim 5 which is not rejected with Song.
Re Claim 1, Bang discloses a method for measuring at least one auscultation data signal from at least one acoustic sensor disposed on a user having a need to measure or monitor the at least one auscultation data signal, the method comprising:
disposing a wearable on a user; and measuring the at least one auscultation data signal of the user with at least one sensor disposed in the wearable (fig. 3, para. [095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal -related auscultation, and/or proximate a joint for orthopedic-related auscultation),
storing the at least one auscultation data signal into memory as stored data (para. [091], [110], Memory 168 can be configured to store data recorded by one or more functional elements and received by processor 165; para. [125], devices 100 and/or 200 are configured to record and store data (e.g. as memory permits) until the patient requests, via user device 300, to download the recorded data from devices 100 and/or 200 to user device 300); and
processing the stored data with an algorithm for detection of one or more medical issues (para. [0050], The diagnostic system can include a phonocardiogram to detect changes in heart sounds (e.g. SI, S2, S3, S4) and/or lung sounds; para. [0051], heart failure; para. [0095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal-related auscultation, and/or proximate a joint for orthopedic-related auscultation, such as to provide data complementary to data provided by implantable device 100 and/or otherwise improve the diagnosis provided by system 10),
wherein the device performs real-time, continuous monitoring for a plurality of days without a need for removal from the user (para. [049], [050], [051], [063], The diagnostic system can monitor these parameters for a continuous period of time (e.g. continuously for up to 5 years). The diagnostic system can be configured to provide continuous and/or long-term monitoring of the patient, such as to aid in providing an accurate diagnosis; para. [112], System 10 can be implemented to conduct a 120-hour continuous Holter monitor-like test (e.g. to measure the heart activity of the patient, such as the rate and rhythm of the heart). In some embodiments, system 10 is configured to analyze a data set of both ECG data and PCG (phonocardiogram) data, such as to produce electromechanical activate time (EMAT) data, such as to diagnose heart failure of the patient; para. [094], External device 200 can comprise a disposable device, such as a device configured to be worn by the patient for a particular period (e.g. 3 days, or one week), and then discarded and replaced. Alternatively or additionally, external device 200 can comprise a replaceable adhesive pad, such that the user can replace the adhesive pad after the first pad’s adhesive properties have sufficiently deteriorated.).
Re Claim 5, Bang discloses that the at least one auscultation data signals include sounds from a joint of the user (para. [095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal -related auscultation, and/or proximate a joint for orthopedic-related auscultation).
Re Claim 16, Bang discloses a method for measuring at least one auscultation data signal from at least one acoustic sensor disposed on a user having a need to measure or monitor the at least one auscultation data signal, the method comprising:
disposing a wearable on a user; and measuring the at least one auscultation data signal of the user with at least one sensor disposed in the wearable (fig. 3, para. [095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal -related auscultation, and/or proximate a joint for orthopedic-related auscultation),
storing the at least one auscultation data signal into memory as stored data (para. [091], [110], Memory 168 can be configured to store data recorded by one or more functional elements and received by processor 165; para. [125], devices 100 and/or 200 are configured to record and store data (e.g. as memory permits) until the patient requests, via user device 300, to download the recorded data from devices 100 and/or 200 to user device 300); and
processing the stored data with an algorithm for detection of one or more medical issues (para. [0050], The diagnostic system can include a phonocardiogram to detect changes in heart sounds (e.g. SI, S2, S3, S4) and/or lung sounds; para. [0051], heart failure; para. [0095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal-related auscultation, and/or proximate a joint for orthopedic-related auscultation, such as to provide data complementary to data provided by implantable device 100 and/or otherwise improve the diagnosis provided by system 10),
wherein the device performs real-time, continuous monitoring for a plurality of days without a need for removal from the user (para. [049], [050], [051], [063], The diagnostic system can monitor these parameters for a continuous period of time (e.g. continuously for up to 5 years). The diagnostic system can be configured to provide continuous and/or long-term monitoring of the patient, such as to aid in providing an accurate diagnosis; para. [112], System 10 can be implemented to conduct a 120-hour continuous Holter monitor-like test (e.g. to measure the heart activity of the patient, such as the rate and rhythm of the heart). In some embodiments, system 10 is configured to analyze a data set of both ECG data and PCG (phonocardiogram) data, such as to produce electromechanical activate time (EMAT) data, such as to diagnose heart failure of the patient; para. [094], External device 200 can comprise a disposable device, such as a device configured to be worn by the patient for a particular period (e.g. 3 days, or one week), and then discarded and replaced. Alternatively or additionally, external device 200 can comprise a replaceable adhesive pad, such that the user can replace the adhesive pad after the first pad’s adhesive properties have sufficiently deteriorated.), and
the at least one auscultation data signals are detected and recorded directly from a surface of the user (para. [094], [095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal -related auscultation, and/or proximate a joint for orthopedic-related auscultation).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-4, 13, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Song (US 2013/0237863 A1) in view of Tran (US 2013/0172691 A1).
Re Claim 1, Song discloses a method for measuring at least one auscultation data signal from at least one acoustic sensor disposed on a user having a need to measure or monitor the at least one auscultation data signal, the method comprising:
disposing a wearable on a user (fig. 1, para. [0038], an external patch 16 with acoustic sensors 18 and 20); and
measuring the at least one auscultation data signal of the user with at least one sensor disposed in the wearable (para. [0038], external patch 16 is placed so that acoustic sensors 18 and 20 are located over spaces between the ribs. This also allows for better capture of the heart sounds),
storing the at least one auscultation data signal into memory as stored data (para. [0053], Processor 44 or signal analyzer 46 may store the heart sound signal parameters and lung sound signal parameters in memory 48.); and
processing the stored data with an algorithm for detection of one or more medical issues (para. [0030]-[0033], correlation between heart and/or lung sounds are used to monitor pulmonary hypertension, including progression and treatment.).
Song further discloses the device performing real-time, continuous monitoring without a need for removal from the user (para. [0030], the use of an external patch may allow for a patient to be monitored continuously or at regular intervals without the need for invasive procedures to determine pulmonary arterial blood pressure).
Song is silent regarding wherein the device performs real-time, continuous monitoring for a plurality of days without a need for removal from the user.
However, Tran discloses real-time monitoring of blood pressure where data are measured several times each day to provide a relatively comprehensive data set compared to that measured during medical appointments separated by several weeks or even months (para. [0020]). Tran also discloses that the patient continuously wears the blood-pressure monitor for a short period of time, e.g. one or two weeks after visiting a medical professional during a typical ‘check up’ or after signing up for a short-term monitoring program through the website (para. [0193]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Song, by configuring the device to perform real-time, continuous monitoring for a plurality of days without a need for removal from the user, as taught by Tran, for the purpose of providing a relatively comprehensive data set compared to that measured during medical appointments separated by several weeks or even months (para. [0020])
Re Claim 2, Song discloses that the collected data is sent to a healthcare provider to assess the user’s control of an illness, to provide suggestions to adjust medication dosage, or to suggest different medication to the user (para. [0093], Programmer 24 may provide an alert to patient 12 indicating the need to check in with his or her physician regarding treatment of pulmonary hypertension. The physician may in turn start patient 12 on medicine to treat the pulmonary hypertension. In some examples, the indication of pulmonary hypertension may be provided to a drug pump. The drug pump may provide a dose of medication to patient 12 based on the level of pulmonary hypertension present; para. [0094], In some examples, the indication of a need for heart failure treatment may be provided to a physician via programmer 24. The physician may manually change one or more treatment parameters.).
Re Claim 3, Song discloses that the at least one auscultation data signal includes sounds from one or more organs (para. [0095], acoustic sensors collect heart signals).
Re Claim 4, Song discloses that the one or more organs includes the heart (para. [0095], acoustic sensors collect heart signals).
Re Claim 13, Song discloses that the at least one auscultation data signals are detected and recorded directly from a surface of the user between a waist and a base of a neck of the user (para. [0038], fig. 1, External patch 16 is placed on patient 12 over sternum 22 so that acoustic sensor 18 over the right side of the heart 14 and acoustic sensor 20 is over the left side of heart 14.).
Re Claim 16, Song discloses a method for measuring at least one auscultation data signal from at least one acoustic sensor disposed on a user having a need to measure or monitor the at least one auscultation data signal, the method comprising:
disposing a wearable on a user (fig. 1, para. [0038], an external patch 16 with acoustic sensors 18 and 20); and
measuring the at least one auscultation data signal of the user with at least one sensor disposed in the wearable (para. [0038], external patch 16 is placed so that acoustic sensors 18 and 20 are located over spaces between the ribs. This also allows for better capture of the heart sounds),
storing the at least one auscultation data signal into memory as stored data (para. [0053], Processor 44 or signal analyzer 46 may store the heart sound signal parameters and lung sound signal parameters in memory 48.); and
processing the stored data with an algorithm for detection of one or more medical issues (para. [0030]-[0033], correlation between heart and/or lung sounds are used to monitor pulmonary hypertension, including progression and treatment.); and
the at least one auscultation data signals are detected and recorded directly from a surface of the user (para. [0038], fig. 1, External patch 16 is placed on patient 12 over sternum 22 so that acoustic sensor 18 over the right side of the heart 14 and acoustic sensor 20 is over the left side of heart 14.).
Song further discloses the device performing real-time, continuous monitoring without a need for removal from the user (para. [0030], the use of an external patch may allow for a patient to be monitored continuously or at regular intervals without the need for invasive procedures to determine pulmonary arterial blood pressure).
Song is silent regarding wherein the device performs real-time, continuous monitoring for a plurality of days without a need for removal from the user.
However, Tran discloses real-time monitoring of blood pressure where data are measured several times each day to provide a relatively comprehensive data set compared to that measured during medical appointments separated by several weeks or even months (para. [0020]). Tran also discloses that the patient continuously wears the blood-pressure monitor for a short period of time, e.g. one or two weeks after visiting a medical professional during a typical ‘check up’ or after signing up for a short-term monitoring program through the website (para. [0193]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Song, by configuring the device to perform real-time, continuous monitoring for a plurality of days without a need for removal from the user, as taught by Tran, for the purpose of providing a relatively comprehensive data set compared to that measured during medical appointments separated by several weeks or even months (para. [0020])
Re Claim 17, Song discloses that the at least one auscultation data signals includes sounds from at least one organ (para. [0095], acoustic sensors collect heart signals).
Re Claim 18, Song discloses that the organ is the heart (para. [0095], acoustic sensors collect heart signals).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Song (US 2013/0237863 A1), as modified by Tran (US 2013/0172691 A1) and further in view of Sullivan (WO 2008/148172).
Re Claim 14, Song as modified by Tran discloses the claimed invention substantially as set forth in claim 1.
Song is silent regarding the at least one acoustic sensor is embedded in a protective layer that facilitates sound transfer through a housing of the device.
Sullivan discloses a sensor automatically provides for auscultation and discloses that the at least one acoustic sensor is embedded in a protective layer that facilitates sound transfer through a housing of the device (page 4, abstract, a sound vibration sensing element in the form of a PVDF membrane. An impedance matching layer on top of the membrane transmits fine breath sounds through to the membrane as the latex does not weaken or attenuate the fine breath sounds but transmits them to the PVDF membrane).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Song as modified by Tran, to configure the at least one acoustic sensor to be embedded in a protective layer that facilitates sound transfer through a housing of the device, as taught by Sullivan, for the purpose of transmitting fine sounds through the sensor without attenuating them significantly (page 4).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Song (US 2013/0237863 A1), as modified by Tran (US 2013/0172691 A1) and further in view of Bang et al. (WO 2020/243463A1)
Re Claim 19, Song as modified by Tran discloses the claimed invention substantially as set forth in claims 16, 17, and 18.
Song is silent regarding wherein the at least one auscultation data signals includes sounds from a joint of the user.
However, Bang discloses disposing a wearable on a user; and measuring the at least one auscultation data signal of the user with at least one sensor disposed in the wearable (fig. 3, para. [095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal -related auscultation, and/or proximate a joint for orthopedic-related auscultation) and discloses that the at least one auscultation data signals includes sounds from a joint of the user (para. [095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal-related auscultation, and/or proximate a joint for orthopedic-related auscultation).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Song as modified by Tran, by configuring the at least one auscultation data signals to include sounds from a joint of the user, as taught by Bang, for the purpose of providing data complementary to heart sound data to improve the diagnosis (para. [0095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal-related auscultation, and/or proximate a joint for orthopedic-related auscultation, such as to provide data complementary to data provided by implantable device 100 and/or otherwise improve the diagnosis provided by system 10; para. [050], The diagnostic system can include a phonocardiogram to detect changes in heart sounds (e.g. SI, S2, S3, S4) and/or lung sounds; para. [0051], heart failure).
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 VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, August 14, 2026Examiner, Art Unit 3792
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