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 1-7, 9-18, 21, and 22 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 25, 2025 has been entered.
Election/Restrictions
Applicant’s election without traverse of Invention I, claims 1-18 in the reply filed on December 6, 2024 is acknowledged.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 13 have been considered but are moot because the new ground of rejection has been made necessitated by amendments.
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.
Claims 1, 7, 13, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sundaram et al. (US 2018/0247095).
Re Claim 1, Sundaram discloses a hemodynamic monitoring system for wirelessly measuring a hemodynamic parameter from a remote location, comprising:
a wireless reader device; a wireless passive sensor, wherein the wireless reader is configured to communicate with the wireless passive sensor (para. [0036], a wireless sensor with a reader device. To initiate communication, the reader device 10 may be placed in proximity to the sensor 12 and capable of exciting the sensor 12 by transmitting a signal 14 (excitation pulse), such as a radio frequency (“RF”) pulse, at or near the resonant frequency of the sensor 12. Note that as used herein, “excitation” pulse is any signal 14 transmitted from the reader to the sensor, that evinces a response signal 12 from the sensor. For passive sensors with no internal energy storage, the excitation signal 14 may power the sensor 12, enabling it to emit a response signal 16; para. [0040]);
said wireless passive sensor configured to be implanted in a vasculature of a user (para. [0055], a wireless sensor 12 may be implanted into the area of the body where the measurement is to be taken. In an embodiment, the wireless sensor 12 can be a cardiovascular pressure sensor that may be implanted in the body using a delivery catheter 220; para. [0036], In particular, the sensor 12 may be designed to be placed within the cardiovascular system of a human to provide a signal that may be a function of a sensed parameter (such as blood pressure) that is desirable to be identified.);
wherein the wireless reader device communicates with the wireless passive sensor by being placed in proximity to the wireless passive sensor when the wireless passive sensor is implanted into a body of a user to measure at least one hemodynamic parameter of the user (para. [0036], a wireless sensor with a reader device. To initiate communication, the reader device 10 may be placed in proximity to the sensor 12 and capable of exciting the sensor 12 by transmitting a signal 14 (excitation pulse), such as a radio frequency (“RF”) pulse, at or near the resonant frequency of the sensor 12. Note that as used herein, “excitation” pulse is any signal 14 transmitted from the reader to the sensor, that evinces a response signal 12 from the sensor. For passive sensors with no internal energy storage, the excitation signal 14 may power the sensor 12, enabling it to emit a response signal 16. After the excitation pulse 14 is extinguished, the sensor 12 may emit a response signal 16 for a short period of time in response to the signal/excitation pulse 14 from the reader device 10. In particular, the sensor 12 may be designed to be placed within the cardiovascular system of a human to provide a signal that may be a function of a sensed parameter (such as blood pressure) that is desirable to be identified. The reader device 10 may be configured to receive and ascertain the frequency of the response signal 16 via wireless communication with the sensor 12 and extrapolate the sensed parameter. In another embodiment, the excitation signal 14 may be a continuous signal that is not extinguished prior to receiving response signal 16.; para. [0040]; para. [0055], a wireless sensor 12 may be implanted into the area of the body where the measurement is to be taken. In an embodiment, the wireless sensor 12 can be a cardiovascular pressure sensor that may be implanted in the body using a delivery catheter 220);
wherein the wireless reader device is controlled to receive at least one response signal from said wireless passive sensor while the user is experiencing at least one of a set of patient states wherein the at least one response signal is representative of a physiologic parameter of the user (para. [0036], a wireless sensor with a reader device. To initiate communication, the reader device 10 may be placed in proximity to the sensor 12 and capable of exciting the sensor 12 by transmitting a signal 14 (excitation pulse), such as a radio frequency (“RF”) pulse, at or near the resonant frequency of the sensor 12. Note that as used herein, “excitation” pulse is any signal 14 transmitted from the reader to the sensor, that evinces a response signal 12 from the sensor. For passive sensors with no internal energy storage, the excitation signal 14 may power the sensor 12, enabling it to emit a response signal 16. After the excitation pulse 14 is extinguished, the sensor 12 may emit a response signal 16 for a short period of time in response to the signal/excitation pulse 14 from the reader device 10. In particular, the sensor 12 may be designed to be placed within the cardiovascular system of a human to provide a signal that may be a function of a sensed parameter (such as blood pressure) that is desirable to be identified. The reader device 10 may be configured to receive and ascertain the frequency of the response signal 16 via wireless communication with the sensor 12 and extrapolate the sensed parameter. In another embodiment, the excitation signal 14 may be a continuous signal that is not extinguished prior to receiving response signal 16; para. [0040]; para. [0055], a wireless sensor 12 may be implanted into the area of the body where the measurement is to be taken. In an embodiment, the wireless sensor 12 can be a cardiovascular pressure sensor that may be implanted in the body using a delivery catheter 220; para. [0077], The reader device 10 may include a tilt sensor 28 such as an accelerometer or other type of position sensor to allow the reader device 10 to identify if the patient is sitting/standing, or laying down during the reading (See FIG. 2));
wherein said wireless reader device further comprises at least one activity monitoring sensor wherein data from said at least one activity monitoring sensor is used to control the wireless reader device to receive at least one response signal from said wireless passive sensor (para. [0077], The reader device 10 may include a tilt sensor 28 such as an accelerometer or other type of position sensor to allow the reader device 10 to identify if the patient is sitting/standing, or laying down during the reading (See FIG. 2). The tilt sensor 28 may measure a tilt of the reader device 10 along one or more axes normal to the reader surfaces 122 with respect to earth's gravity. The patient's position may affect the sensed parameter, e.g. pulmonary artery pressure (and other pressures inside the body), due to shifting of one's body mass. For embodiments where the tilt sensor 28 is an accelerometer, the accelerometer may also provide an indication that a patient is walking or moving in a vehicle (car or wheelchair) while taking a reading, or whether the patient's hand is shaking while holding the reader device 10. Further, it may be desirable for the patient to be in the same position (upright versus supine) for each reading, to ensure reading consistency. To ensure this, the reader device 10 may issue an A/V/H signal prompting the patient to assume to correct position, if the tilt sensor 28 detects an incorrect position. The reader device 10 may further not take a reading until the position has been corrected).
Re Claim 7, Sundaram discloses that wherein said activity monitoring sensor is selected from among: an accelerometer; a tilt sensor; a geo-locationaldevice; an audio, visual, haptic, touchscreen or pushbutton user interface; a heartrate sensor; a respiration rate sensor; and a body temperature sensor (para. [0077], The reader device 10 may include a tilt sensor 28 such as an accelerometer or other type of position sensor to allow the reader device 10 to identify if the patient is sitting/standing, or laying down during the reading (See FIG. 2).).
Re Claim 13, Sundaram discloses a method for monitoring hemodynamic parameters of a user with a wireless passive sensor located within a body of a user, said method comprising the steps of:
providing a reader device configured to wirelessly transfer energy, data, or commands to and from said wireless passive sensor (para. [0036], a wireless sensor with a reader device. To initiate communication, the reader device 10 may be placed in proximity to the sensor 12 and capable of exciting the sensor 12 by transmitting a signal 14 (excitation pulse), such as a radio frequency (“RF”) pulse, at or near the resonant frequency of the sensor 12. Note that as used herein, “excitation” pulse is any signal 14 transmitted from the reader to the sensor, that evinces a response signal 12 from the sensor. For passive sensors with no internal energy storage, the excitation signal 14 may power the sensor 12, enabling it to emit a response signal 16; para. [0040]);
placing the reader device in proximity to said wireless passive sensor at a target location on the body of the user to measure at least one physiological parameter of the user (para. [0036], a wireless sensor with a reader device. To initiate communication, the reader device 10 may be placed in proximity to the sensor 12 and capable of exciting the sensor 12 by transmitting a signal 14 (excitation pulse), such as a radio frequency (“RF”) pulse, at or near the resonant frequency of the sensor 12. Note that as used herein, “excitation” pulse is any signal 14 transmitted from the reader to the sensor, that evinces a response signal 12 from the sensor. For passive sensors with no internal energy storage, the excitation signal 14 may power the sensor 12, enabling it to emit a response signal 16. After the excitation pulse 14 is extinguished, the sensor 12 may emit a response signal 16 for a short period of time in response to the signal/excitation pulse 14 from the reader device 10. In particular, the sensor 12 may be designed to be placed within the cardiovascular system of a human to provide a signal that may be a function of a sensed parameter (such as blood pressure) that is desirable to be identified. The reader device 10 may be configured to receive and ascertain the frequency of the response signal 16 via wireless communication with the sensor 12 and extrapolate the sensed parameter. In another embodiment, the excitation signal 14 may be a continuous signal that is not extinguished prior to receiving response signal 16.; para. [0040]; para. [0055], a wireless sensor 12 may be implanted into the area of the body where the measurement is to be taken. In an embodiment, the wireless sensor 12 can be a cardiovascular pressure sensor that may be implanted in the body using a delivery catheter 220);
controlling said reader device to receive at least one response signal from said wireless passive sensor while the user is experiencing at least one of a set of patient states wherein the at least one response signal is representative of a hemodynamic parameter of the user (para. [0036], a wireless sensor with a reader device. To initiate communication, the reader device 10 may be placed in proximity to the sensor 12 and capable of exciting the sensor 12 by transmitting a signal 14 (excitation pulse), such as a radio frequency (“RF”) pulse, at or near the resonant frequency of the sensor 12. Note that as used herein, “excitation” pulse is any signal 14 transmitted from the reader to the sensor, that evinces a response signal 12 from the sensor. For passive sensors with no internal energy storage, the excitation signal 14 may power the sensor 12, enabling it to emit a response signal 16. After the excitation pulse 14 is extinguished, the sensor 12 may emit a response signal 16 for a short period of time in response to the signal/excitation pulse 14 from the reader device 10. In particular, the sensor 12 may be designed to be placed within the cardiovascular system of a human to provide a signal that may be a function of a sensed parameter (such as blood pressure) that is desirable to be identified. The reader device 10 may be configured to receive and ascertain the frequency of the response signal 16 via wireless communication with the sensor 12 and extrapolate the sensed parameter. In another embodiment, the excitation signal 14 may be a continuous signal that is not extinguished prior to receiving response signal 16; para. [0040]; para. [0055], a wireless sensor 12 may be implanted into the area of the body where the measurement is to be taken. In an embodiment, the wireless sensor 12 can be a cardiovascular pressure sensor that may be implanted in the body using a delivery catheter 220; para. [0077], The reader device 10 may include a tilt sensor 28 such as an accelerometer or other type of position sensor to allow the reader device 10 to identify if the patient is sitting/standing, or laying down during the reading (See FIG. 2)),
wherein said wireless reader device further comprises at least one activity monitoring sensor; and controlling the wireless reader device to receive at least one response signal from said wireless passive sensor using data from said at least one activity monitoring sensor (para. [0077], The reader device 10 may include a tilt sensor 28 such as an accelerometer or other type of position sensor to allow the reader device 10 to identify if the patient is sitting/standing, or laying down during the reading (See FIG. 2). The tilt sensor 28 may measure a tilt of the reader device 10 along one or more axes normal to the reader surfaces 122 with respect to earth's gravity. The patient's position may affect the sensed parameter, e.g. pulmonary artery pressure (and other pressures inside the body), due to shifting of one's body mass. For embodiments where the tilt sensor 28 is an accelerometer, the accelerometer may also provide an indication that a patient is walking or moving in a vehicle (car or wheelchair) while taking a reading, or whether the patient's hand is shaking while holding the reader device 10. Further, it may be desirable for the patient to be in the same position (upright versus supine) for each reading, to ensure reading consistency. To ensure this, the reader device 10 may issue an A/V/H signal prompting the patient to assume to correct position, if the tilt sensor 28 detects an incorrect position. The reader device 10 may further not take a reading until the position has been corrected).
Re Claim 17, Sundaram discloses that the activity monitoring sensor is selected from among: an accelerometer; a tilt sensor; a geo-locational device; an audio, visual, haptic, touchscreen or pushbutton user interface; a heartrate sensor; a respiration rate sensor; and a body temperature sensor (para. [0077], The reader device 10 may include a tilt sensor 28 such as an accelerometer or other type of position sensor to allow the reader device 10 to identify if the patient is sitting/standing, or laying down during the reading (See FIG. 2).).
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.
Claim 21 rejected under 35 U.S.C. 103 as being unpatentable over Sundaram et al. (US 2018/0247095) in view of Habib et al. (US 6,682,480).
Re Claim 21, Sundaram discloses a hemodynamic monitoring system for wirelessly measuring a hemodynamic parameter from a remote location, comprising:
a wireless reader device; a wireless passive sensor, wherein the wireless reader is configured to communicate with the wireless passive sensor (para. [0036], a wireless sensor with a reader device. To initiate communication, the reader device 10 may be placed in proximity to the sensor 12 and capable of exciting the sensor 12 by transmitting a signal 14 (excitation pulse), such as a radio frequency (“RF”) pulse, at or near the resonant frequency of the sensor 12. Note that as used herein, “excitation” pulse is any signal 14 transmitted from the reader to the sensor, that evinces a response signal 12 from the sensor. For passive sensors with no internal energy storage, the excitation signal 14 may power the sensor 12, enabling it to emit a response signal 16; para. [0040]) and
wherein said wireless passive sensor configured to be implanted in a vasculature of a user (para. [0055], a wireless sensor 12 may be implanted into the area of the body where the measurement is to be taken. In an embodiment, the wireless sensor 12 can be a cardiovascular pressure sensor that may be implanted in the body using a delivery catheter 220; para. [0036], In particular, the sensor 12 may be designed to be placed within the cardiovascular system of a human to provide a signal that may be a function of a sensed parameter (such as blood pressure) that is desirable to be identified.);
wherein the wireless reader device communicates with the wireless passive sensor by being placed in proximity to the wireless passive sensor when the wireless passive sensor is implanted into a body of the user to measure at least one hemodynamic parameter of the user (para. [0036], a wireless sensor with a reader device. To initiate communication, the reader device 10 may be placed in proximity to the sensor 12 and capable of exciting the sensor 12 by transmitting a signal 14 (excitation pulse), such as a radio frequency (“RF”) pulse, at or near the resonant frequency of the sensor 12. Note that as used herein, “excitation” pulse is any signal 14 transmitted from the reader to the sensor, that evinces a response signal 12 from the sensor. For passive sensors with no internal energy storage, the excitation signal 14 may power the sensor 12, enabling it to emit a response signal 16. After the excitation pulse 14 is extinguished, the sensor 12 may emit a response signal 16 for a short period of time in response to the signal/excitation pulse 14 from the reader device 10. In particular, the sensor 12 may be designed to be placed within the cardiovascular system of a human to provide a signal that may be a function of a sensed parameter (such as blood pressure) that is desirable to be identified. The reader device 10 may be configured to receive and ascertain the frequency of the response signal 16 via wireless communication with the sensor 12 and extrapolate the sensed parameter. In another embodiment, the excitation signal 14 may be a continuous signal that is not extinguished prior to receiving response signal 16.; para. [0040]; para. [0055], a wireless sensor 12 may be implanted into the area of the body where the measurement is to be taken. In an embodiment, the wireless sensor 12 can be a cardiovascular pressure sensor that may be implanted in the body using a delivery catheter 220);
wherein the wireless reader device is controlled to receive at least one response signal from said wireless passive sensor while the user is experiencing at least one of a set of patient states wherein the at least one response signal is representative of a physiologic parameter of the user (para. [0036], a wireless sensor with a reader device. To initiate communication, the reader device 10 may be placed in proximity to the sensor 12 and capable of exciting the sensor 12 by transmitting a signal 14 (excitation pulse), such as a radio frequency (“RF”) pulse, at or near the resonant frequency of the sensor 12. Note that as used herein, “excitation” pulse is any signal 14 transmitted from the reader to the sensor, that evinces a response signal 12 from the sensor. For passive sensors with no internal energy storage, the excitation signal 14 may power the sensor 12, enabling it to emit a response signal 16. After the excitation pulse 14 is extinguished, the sensor 12 may emit a response signal 16 for a short period of time in response to the signal/excitation pulse 14 from the reader device 10. In particular, the sensor 12 may be designed to be placed within the cardiovascular system of a human to provide a signal that may be a function of a sensed parameter (such as blood pressure) that is desirable to be identified. The reader device 10 may be configured to receive and ascertain the frequency of the response signal 16 via wireless communication with the sensor 12 and extrapolate the sensed parameter. In another embodiment, the excitation signal 14 may be a continuous signal that is not extinguished prior to receiving response signal 16; para. [0040]; para. [0055], a wireless sensor 12 may be implanted into the area of the body where the measurement is to be taken. In an embodiment, the wireless sensor 12 can be a cardiovascular pressure sensor that may be implanted in the body using a delivery catheter 220; para. [0077], The reader device 10 may include a tilt sensor 28 such as an accelerometer or other type of position sensor to allow the reader device 10 to identify if the patient is sitting/standing, or laying down during the reading (See FIG. 2));
wherein said wireless reader device further comprises at least one activity monitoring sensor wherein data from said at least one activity monitoring sensor is used to control the wireless reader device to receive at least one response signal from said wireless passive sensor; wherein the wireless reader device is further configured to automatically receive at least one response signal from said wireless passive sensor in response to detection of a specific patient state, the detection being based on data from at least one activity monitoring sensor selected from the group consisting of: an accelerometer, a tilt sensor, a geo-locational device, a heartrate sensor, a respiration rate sensor, and a body temperature sensor, and wherein the at least one response signal is representative of a physiologic parameter of the user (para. [0077], The reader device 10 may include a tilt sensor 28 such as an accelerometer or other type of position sensor to allow the reader device 10 to identify if the patient is sitting/standing, or laying down during the reading (See FIG. 2). The tilt sensor 28 may measure a tilt of the reader device 10 along one or more axes normal to the reader surfaces 122 with respect to earth's gravity. The patient's position may affect the sensed parameter, e.g. pulmonary artery pressure (and other pressures inside the body), due to shifting of one's body mass. For embodiments where the tilt sensor 28 is an accelerometer, the accelerometer may also provide an indication that a patient is walking or moving in a vehicle (car or wheelchair) while taking a reading, or whether the patient's hand is shaking while holding the reader device 10. Further, it may be desirable for the patient to be in the same position (upright versus supine) for each reading, to ensure reading consistency. To ensure this, the reader device 10 may issue an A/V/H signal prompting the patient to assume to correct position, if the tilt sensor 28 detects an incorrect position. The reader device 10 may further not take a reading until the position has been corrected).
Sundaram is silent regarding a harness device configured to support and maintain the wireless reader device in a fixed alignment relative to the wireless passive sensor at a target location on the user, the harness device being adjustable to minimize angular misalignment between the wireless reader device and the wireless passive sensor during a plurality of patient states, including during movement and exercise, such that the wireless reader device is operable in a hands-free manner.
However, Habib discloses a chip-sized passive sensor which is adapted (a) to receive and to rectify an electromagnetic signal with a frequency of 1-2 Ghz directed from outside the body towards it and to derive its operating power directly from the electromagnetic signal, and (b) to use its thus obtained operating power to transmit data relating to treatment by wireless telemetry to a receiver external to the body of the human or non-human animal (abstract). Habib teaches a harness device configured to support and maintain the wireless reader device in a fixed alignment relative to the wireless passive sensor at a target location on the user, the harness device being adjustable to minimize angular misalignment between the wireless reader device and the wireless passive sensor during a plurality of patient states, including during movement and exercise, such that the wireless reader device is operable in a hands-free manner (col. 3, line 65 – col. 4, line 13, one or more sensor chips 1 are implanted into the malignant region of a patient's liver. A sensor chip incorporating these components may be no more than 10 mm long, 2 mm wide and 1 mm thick. To activate the sensor chip, a reader/interrogator 6 is used to irradiate the sensor chip(s) with a radio signal which is of sufficient power to enable the rectenna 3 to generate a voltage large enough to cause the electromagnetic component 4 of the sensor to function. The reader unit 6 will normally be located just outside, and close to, the body of the patient; it may for example be hand-held; attached to a belt around the patient's body; or otherwise located in a substantially fixed position relative to the body.).
Examiner notes that the claim language “the harness device being adjustable to minimize angular misalignment between the wireless reader device and the wireless passive sensor during a plurality of patient states, including during movement and exercise, such that the wireless reader device is operable in a hands-free manner” is an intended use, and Habib’s reader that is attached to a belt around the patient’s body is adjustable to perform the claimed function.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Habib, by adding a harness device configured to support and maintain the wireless reader device in a fixed alignment relative to the wireless passive sensor at a target location on the user, the harness device being adjustable to minimize angular misalignment between the wireless reader device and the wireless passive sensor during a plurality of patient states, including during movement and exercise, such that the wireless reader device is operable in a hands-free manner, as taught by Habib, for the purpose of increasing portability and convenience of the user.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Sundaram et al. (US 2018/0247095) as modified by Habib et al. (US 6,682,480), and further in view of Bennett et al. (US 2012/0108984).
Re Claim 22, Sundaram as modified by Habib discloses the claimed invention substantially as set forth in claim 21.
Sundaram and Habib are silent regarding said hemodynamic parameter being pulmonary artery pressure recorded as a continuous waveform measured over a time period.
However, Bennett discloses a hemodynamic monitoring system for wirelessly measuring a hemodynamic parameter from a remote location and teaches a wireless sensor configured to be implanted in the vasculature of a user to measure at least one hemodynamic parameter of the user, wherein said hemodynamic parameter is pulmonary artery pressure recorded as a continuous waveform measured over a time period (para. [0003], implanted sensor that senses at least one physiological parameter, e.g., pulmonary artery pressure; para. [0073], sensor 40 may be an ultrasound sensor implanted on the pulmonary artery to monitor flow and estimate the diastolic and even systolic pressures within the pulmonary artery; para. [0085], wireless pressure sensor 40; para. [0057], Sensor 22 may sense physiological parameters indicative of the condition continuously, periodically, or in response to any event and transmit an indication of the sensed parameters to clinician module 16 or therapy module 18 as required for management of the medical condition (e.g., HF)).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Sundaram as modified by Habib, by configuring said hemodynamic parameter to be pulmonary artery pressure recorded as a continuous waveform measured over a time period, as taught by Bennett, for the purpose of using the pulmonary artery pressure as an indicator of the progression of congestive heart failure of patient (para. [0056]).
Claims 1-6 and 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bennett et al. (US 20120108984) in view of Sundaram et al. (US 2018/0247095).
Examiner notes: These grounds of rejection are given in order to give the best grounds of rejection for dependent claims 2-6, 11-12, and 14-16 which are not rejected with Sundaram.
Re Claim 1, Bennett discloses a hemodynamic monitoring system for wirelessly measuring a hemodynamic parameter from a remote location, comprising:
a wireless reader device configured to communicate with a wireless sensor (para. [0068], Patient module 32 may be substantially similar to patient module 14 (FIG. 1) and may be configured as a component of integrated patient care system 30. Patient module 32 includes patient interface 42 that includes a display to present information to patient 12 and one or more devices that receive input from patient 12. Patient module 32 also includes sensor 40 that is configured to sense right ventricular pressure of patient 12, which may be used to monitor the congestive heart failure of patient 12. Sensor 40 of FIG. 2 includes pressure sensor 48 and data storage 50. In other examples, sensor 40 may include a separate processor or other components used to detect a condition of patient 12, para. [0070]);
said wireless sensor configured to be implanted in the vasculature of a user (para. [0003], implanted sensor that senses at least one physiological parameter, e.g., pulmonary artery pressure; para. [0073], sensor 40 may be an ultrasound sensor implanted on the pulmonary artery to monitor flow and estimate the diastolic and even systolic pressures within the pulmonary artery; para. [0085], wireless pressure sensor 40);
wherein the wireless reader device communicates with the wireless sensor by being placed in proximity to the wireless sensor when the wireless sensor is implanted into the body of a user to measure at least one hemodynamic parameter of the user; wherein the wireless reader device is controlled to receive at least one response signal from said wireless sensor while the user is experiencing at least one of a set of patient states wherein the at least one response signal is representative of a physiologic parameter of the user (fig. 2, para. [0068], [0070], patient module 32 also includes sensor 40 to receive input from patient 12; para. [0085], In examples in which sensor 40 includes a wireless sensor 40, sensor 40 may include a power source, processor, telemetry module, and anything else required for sensor 40 to function. In this manner, programmer 72 may receive sensed pressures, e.g., physiological parameters, from sensor 40; para. [0084], In other examples of FIG. 2, therapy module 36 may use a different technique other than stored therapy instructions 57 to detect conditions and select a therapy regimen based on the detection. For example, in some examples, the physiological parameters, e.g., pulmonary pressure, may be transmitted from sensor 40 and patient module 32 to therapy module 36 via network 38; para. [0076], [0081], condition identifiers (e.g., pressure range or pressure change) should be used to detect the patient conditions).
Bennett is silent regarding a wireless passive sensor, wherein the wireless reader is configured to communicate with the wireless passive sensor, wherein said wireless reader device further comprises at least one activity monitoring sensor wherein data from said at least one activity monitoring sensor is used to control the wireless reader device to receive at least one response signal from said wireless passive sensor.
Sundaram discloses a hemodynamic monitoring system for wirelessly measuring a hemodynamic parameter from a remote location, comprising:
a wireless reader device; a wireless passive sensor, wherein the wireless reader is configured to communicate with the wireless passive sensor (para. [0036], a wireless sensor with a reader device. To initiate communication, the reader device 10 may be placed in proximity to the sensor 12 and capable of exciting the sensor 12 by transmitting a signal 14 (excitation pulse), such as a radio frequency (“RF”) pulse, at or near the resonant frequency of the sensor 12. Note that as used herein, “excitation” pulse is any signal 14 transmitted from the reader to the sensor, that evinces a response signal 12 from the sensor. For passive sensors with no internal energy storage, the excitation signal 14 may power the sensor 12, enabling it to emit a response signal 16; para. [0040]);
said wireless passive sensor configured to be implanted in a vasculature of a user (para. [0055], a wireless sensor 12 may be implanted into the area of the body where the measurement is to be taken. In an embodiment, the wireless sensor 12 can be a cardiovascular pressure sensor that may be implanted in the body using a delivery catheter 220; para. [0036], In particular, the sensor 12 may be designed to be placed within the cardiovascular system of a human to provide a signal that may be a function of a sensed parameter (such as blood pressure) that is desirable to be identified.);
wherein the wireless reader device communicates with the wireless passive sensor by being placed in proximity to the wireless passive sensor when the wireless passive sensor is implanted into a body of a user to measure at least one hemodynamic parameter of the user (para. [0036], a wireless sensor with a reader device. To initiate communication, the reader device 10 may be placed in proximity to the sensor 12 and capable of exciting the sensor 12 by transmitting a signal 14 (excitation pulse), such as a radio frequency (“RF”) pulse, at or near the resonant frequency of the sensor 12. Note that as used herein, “excitation” pulse is any signal 14 transmitted from the reader to the sensor, that evinces a response signal 12 from the sensor. For passive sensors with no internal energy storage, the excitation signal 14 may power the sensor 12, enabling it to emit a response signal 16. After the excitation pulse 14 is extinguished, the sensor 12 may emit a response signal 16 for a short period of time in response to the signal/excitation pulse 14 from the reader device 10. In particular, the sensor 12 may be designed to be placed within the cardiovascular system of a human to provide a signal that may be a function of a sensed parameter (such as blood pressure) that is desirable to be identified. The reader device 10 may be configured to receive and ascertain the frequency of the response signal 16 via wireless communication with the sensor 12 and extrapolate the sensed parameter. In another embodiment, the excitation signal 14 may be a continuous signal that is not extinguished prior to receiving response signal 16.; para. [0040]; para. [0055], a wireless sensor 12 may be implanted into the area of the body where the measurement is to be taken. In an embodiment, the wireless sensor 12 can be a cardiovascular pressure sensor that may be implanted in the body using a delivery catheter 220);
wherein the wireless reader device is controlled to receive at least one response signal from said wireless passive sensor while the user is experiencing at least one of a set of patient states wherein the at least one response signal is representative of a physiologic parameter of the user (para. [0036], a wireless sensor with a reader device. To initiate communication, the reader device 10 may be placed in proximity to the sensor 12 and capable of exciting the sensor 12 by transmitting a signal 14 (excitation pulse), such as a radio frequency (“RF”) pulse, at or near the resonant frequency of the sensor 12. Note that as used herein, “excitation” pulse is any signal 14 transmitted from the reader to the sensor, that evinces a response signal 12 from the sensor. For passive sensors with no internal energy storage, the excitation signal 14 may power the sensor 12, enabling it to emit a response signal 16. After the excitation pulse 14 is extinguished, the sensor 12 may emit a response signal 16 for a short period of time in response to the signal/excitation pulse 14 from the reader device 10. In particular, the sensor 12 may be designed to be placed within the cardiovascular system of a human to provide a signal that may be a function of a sensed parameter (such as blood pressure) that is desirable to be identified. The reader device 10 may be configured to receive and ascertain the frequency of the response signal 16 via wireless communication with the sensor 12 and extrapolate the sensed parameter. In another embodiment, the excitation signal 14 may be a continuous signal that is not extinguished prior to receiving response signal 16; para. [0040]; para. [0055], a wireless sensor 12 may be implanted into the area of the body where the measurement is to be taken. In an embodiment, the wireless sensor 12 can be a cardiovascular pressure sensor that may be implanted in the body using a delivery catheter 220; para. [0077], The reader device 10 may include a tilt sensor 28 such as an accelerometer or other type of position sensor to allow the reader device 10 to identify if the patient is sitting/standing, or laying down during the reading (See FIG. 2));
wherein said wireless reader device further comprises at least one activity monitoring sensor wherein data from said at least one activity monitoring sensor is used to control the wireless reader device to receive at least one response signal from said wireless passive sensor (para. [0077], The reader device 10 may include a tilt sensor 28 such as an accelerometer or other type of position sensor to allow the reader device 10 to identify if the patient is sitting/standing, or laying down during the reading (See FIG. 2). The tilt sensor 28 may measure a tilt of the reader device 10 along one or more axes normal to the reader surfaces 122 with respect to earth's gravity. The patient's position may affect the sensed parameter, e.g. pulmonary artery pressure (and other pressures inside the body), due to shifting of one's body mass. For embodiments where the tilt sensor 28 is an accelerometer, the accelerometer may also provide an indication that a patient is walking or moving in a vehicle (car or wheelchair) while taking a reading, or whether the patient's hand is shaking while holding the reader device 10. Further, it may be desirable for the patient to be in the same position (upright versus supine) for each reading, to ensure reading consistency. To ensure this, the reader device 10 may issue an A/V/H signal prompting the patient to assume to correct position, if the tilt sensor 28 detects an incorrect position. The reader device 10 may further not take a reading until the position has been corrected).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bennett, adding a wireless reader device, a wireless passive sensor, wherein the wireless reader is configured to communicate with the wireless passive sensor, wherein said wireless reader device further comprises at least one activity monitoring sensor wherein data from said at least one activity monitoring sensor is used to control the wireless reader device to receive at least one response signal from said wireless passive sensor, as taught by Sundaram, for the purpose of identifying patient’s body position and activity, prompting the patient to assume to correct position, if the tilt sensor detects an incorrect position, and configuring the reader device not to take a reading until the position has been corrected since the patient's position may affect the sensed parameter, e.g. pulmonary artery pressure (para. [0077]) and for the purpose of lower power consumption, reduced complexity, and cost-effectiveness.
Re Claim 13, Claim 13 is rejected under substantially the same basis as claim 1. Bennett further discloses placing the reader device in proximity to said wireless sensor at a target location on the body of the user to measure at least one physiological parameter of the user (fig. 1, fig. 2, para. [0036], patient module 14 may include a handheld computing device, para. [0038], Sensor 22 of patient module 14 may be any sensor configured to sense a physiological parameter of patient 12 useful for detecting a condition of patient 12 related to the patient's medical condition. In other words, the physiological parameter sensed by sensor 22 may be a specific value or signal generated from sensor 22, and a processor of patient module 14 may use this value or signal to detect conditions of the patient). Sundaram discloses placing the reader device in proximity to said wireless passive sensor at a target location on the body of the user to measure at least one physiological parameter of the user (para. [0036], a wireless sensor with a reader device. To initiate communication, the reader device 10 may be placed in proximity to the sensor 12 and capable of exciting the sensor 12 by transmitting a signal 14 (excitation pulse), such as a radio frequency (“RF”) pulse, at or near the resonant frequency of the sensor 12. Note that as used herein, “excitation” pulse is any signal 14 transmitted from the reader to the sensor, that evinces a response signal 12 from the sensor. For passive sensors with no internal energy storage, the excitation signal 14 may power the sensor 12, enabling it to emit a response signal 16. After the excitation pulse 14 is extinguished, the sensor 12 may emit a response signal 16 for a short period of time in response to the signal/excitation pulse 14 from the reader device 10. In particular, the sensor 12 may be designed to be placed within the cardiovascular system of a human to provide a signal that may be a function of a sensed parameter (such as blood pressure) that is desirable to be identified. The reader device 10 may be configured to receive and ascertain the frequency of the response signal 16 via wireless communication with the sensor 12 and extrapolate the sensed parameter. In another embodiment, the excitation signal 14 may be a continuous signal that is not extinguished prior to receiving response signal 16.; para. [0040]; para. [0055], a wireless sensor 12 may be implanted into the area of the body where the measurement is to be taken. In an embodiment, the wireless sensor 12 can be a cardiovascular pressure sensor that may be implanted in the body using a delivery catheter 220).
Re Claim 2, Bennett discloses that said hemodynamic parameter is pulmonary artery pressure recorded as a continuous waveform measured over a time period (para. [0057], Sensor 22 may sense physiological parameters indicative of the condition continuously, periodically, or in response to any event and transmit an indication of the sensed parameters to clinician module 16 or therapy module 18 as required for management of the medical condition (e.g., HF); para. [0003], implanted sensor that senses at least one physiological parameter, e.g., pulmonary artery pressure; para. [0073], sensor 40 may be an ultrasound sensor implanted on the pulmonary artery to monitor flow and estimate the diastolic and even systolic pressures within the pulmonary artery).
Re Claim 3, Bennett discloses that said set of patient states is a point in time either before, during, or after at least one of: an exercise period, a sleep period, and a period when the user is experiencing symptoms or signs of a medical condition (para. [0084], In other examples of FIG. 2, therapy module 36 may use a different technique other than stored therapy instructions 57 to detect conditions and select a therapy regimen based on the detection. For example, in some examples, the physiological parameters, e.g., pulmonary pressure, may be transmitted from sensor 40 and patient module 32 to therapy module 36 via network 38; para. [0076], [0081], condition identifiers (e.g., pressure range or pressure change) should be used to detect the patient conditions; para. [0056], pulmonary artery pressure may be used as an indicator of the progression of congestive heart failure of patient).
Re Claim 14, Bennett discloses that said set of patient states is a point in time either before, during or after at least one of: an exercise period, a sleep period, and a period when the user is experiencing symptoms or signs of a medical condition (para. [0084], In other examples of FIG. 2, therapy module 36 may use a different technique other than stored therapy instructions 57 to detect conditions and select a therapy regimen based on the detection. For example, in some examples, the physiological parameters, e.g., pulmonary pressure, may be transmitted from sensor 40 and patient module 32 to therapy module 36 via network 38; para. [0076], [0081], condition identifiers (e.g., pressure range or pressure change) should be used to detect the patient conditions; para. [0056], pulmonary artery pressure may be used as an indicator of the progression of congestive heart failure of patient).
Re Claim 4, Bennett discloses that said set of patient states is a point in time either before, during, or after at least one of: a period when the user is in a seated body posture, a period when the user is in a supine body posture, a period when the patient is in a decubitus body posture, a period when the patient is in a prone body posture, a period when the user is in a standing body posture, a period when the user is incapacitated physically or mentally, and a period when the user receives medication or other therapy (para. [0069], In other examples, ancillary data 46 may store information regarding the activity of patient 12, postures of patient 12, or any other data; para. [0071], patient module 32 may detect a posture condition and a pulmonary artery pressure to provide a more complete indication of patient 12 symptoms; para. [0113], These other instructions may be postures that patient 12 should remain in to combat fluid retention, activities to try, or foods to avoid.; para. [0030], Patients afflicted with HF may require daily monitoring to avoid transitioning into acute decompensated heart failure, or decompensation. Decompensation generally refers to exacerbated heart failure and can be characterized by certain signs and symptoms, e.g., shortness of breath and weakness, that may require urgent therapy or hospitalization. In some examples, decompensation may be induced by an intercurrent illness (e.g., pneumonia), myocardial infarction, one or more cardiac arrhythmias, uncontrolled hypertension, or failure of the patient to maintain a fluid restriction, diet, or medication regimen; para. [0056], pulmonary artery pressure may be used as an indicator of the progression of congestive heart failure of patient 12; para. [0056], For example, each condition may relate to a pressure range defined by the therapy instructions (e.g., very low pressure, lo