DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 5-29 with respect to the secondary reference of Bhagat have been considered and are moot because the new ground of rejection does not rely on the Bhagat reference applied in the prior rejection.
Applicant’s arguments with respect to claim(s) 1-3, 5-29 have been considered have been fully considered by are not persuasive. As an initial matter, the rejection has been revised in light of Applicant’s claim amendments, Bhagat is no longer relied upon, and the obviousness rejection of independent Claim 1 (and Claims 21, 27 and 30) is now based on Melodia in view of McCombie.
Applicant argues that Melodia’s acoustic communication is used for networking and node localization, not for physiological parameter determination” and “is not used to determine an inter-sensor distance that is then applied to compute a physiological parameter.”
Examiner disagrees and respectfully submits that the arguments are not commensurate in scope with the claimed invention. The claims do not require the acoustic communication to be used for physiological-parameter determination. As recited, the acoustic communication “enables” determination of a distance between the first and second location, while the physiological parameter is determined via the separately recited RF data communication link. Applicant thus argues limitations not claimed. Melodie is relied upon for its disclosure that on-board ultrasonic transducers “enable” acoustic localization and tracking functionalities, because of their low propagation speed of sound which enables determination of the inter-node distance based on acoustic communication; the physiological use of the distance is supplied by McCombie.
To the extent Applicant argues that Melodia does not itself determine the inter-sensor distance, the rejection does not reply on Melodia alone for that limitation. Melodia is relied upon for the acoustic communication and acoustic localization by which such distance is determined (p. 13, ll. 30-33), and McCombie is now relied upon for the express determination and use of the pulse transit distance between two sensors locations. Therefore, the newly combined references teach “determination…of a distance between the first location and the second location” as claimed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5, 6 and 8, 10-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/123069 A1 to Melodia et al. (hereinafter, Melodia) in view of US 20080039731 A1 to McCombie et al. (hereinafter, McCombie).
Regarding Claims 1, 21, 27 and 30, Melodia discloses a synchronized sensor system, method, apparatus (p. 12, ll. 2-4 “A ultrasonic communication system and method are provided to interconnect a network of intra-body implantable devices and wearable devices, provide an Internet of Medical Things (IoMT) capability, and enhance the configurability of the devices.”) and non-transitory computer-readable apparatus comprising a storage medium, the storage medium comprising a plurality of instructions configured to, when executed by one or more processors (see all of 6.3 Access Point Node beginning at p. 50), cause the system, method, apparatus to comprise inter alia:
a first sensor (implantable slave and/or master nodes, page 21, lines 8-16) disposed at a first location of a user (p. 12, ll. 19-21 “… nodes… deployed along the body of the patient.”) obtaining first measurements associated with the user at the first location (p. 12, ll. 18-10 “Each node comprises… one or more sensors…”) (pg. 12, ll. 9-12 “…measuring, storing, and delivering out-the-body vital biological parameters of the patient as measured by a variety of implantable sensors…”); and
a second sensor (gateway node, p. 48, ll. 25 to p. 49, ll. 20) disposed at a second location of the user (p. 12, ll. 19-21 “… nodes… deployed along the body of the patient.”) obtaining second measurements associated with the user at the second location (p.12, ll. 18-10 “Each node comprises… one or more sensors…”) (p. 12, ll. 9-12 “…measuring, storing, and delivering out-the-body vital biological parameters of the patient as measured by a variety of implantable sensors…”), the second sensor (e.g., gateway node) performing acoustic communication with the first sensor (e.g., implantable slave/master nodes) (p. 12, ll. 19-21 “…nodes can communicate through ultrasound with one or more gateway nodes, each comprising an ultrasonic device…”);
where at least a portion of the acoustic communication with the first sensor enables determination, by the second sensor, of a distance between the first location and the second location (p. 30, ll. 30-33 “On-board ultrasonic transducers can also be used to enable acoustic localization and tracking functionalities, which have better accuracy than RF-based systems because of the low propagation speed of sound in air.” e.g., Melodia’s on board ultrasonic transducers “enable determination” of distances between the at least two sensors of the nodes because they are capable of being localized and tracked via their low propagation speed of sound through air);
the second sensor (e.g., gateway node) performing radio frequency (RF) data communication with:
the first sensor (e.g., implantable slave/master nodes) (p. 49, ll. 16-17 “The gateway node also can embed a low-power RF transceiver that enables communication via RF with the… node(s).”) (p. 45, l. 10 “The implantable node can embed a RF transceiver…”) (p. 12, l. 30-32 “…the communications system employs ultrasonic transmissions for communication between implantable and wearable devices… accompanied by radio frequency transmissions.”),
a host device (e.g., access point node) (p. 49, ll. 16-17 “The gateway node also can embed a low-power RF transceiver that enables communication via RF with the access point node.”) (pg. 12, ll. 21-23 “The gateway nodes enable communication from the intra-body network to access point nodes, each comprising an ultrasonic device, through ultrasound … radio frequency-based technologies.”), or
a combination thereof (p. 12, ll. 30-32 “…system employs ultrasonic transmissions for communication between implantable and wearable devices… accompanied by radio frequency transmission.”),
wherein at least a portion of the RF data communication determines, by the second sensor (e.g., gateway node) or the host device (e.g., access point node), of a physiological parameter associated with the user based on the first measurements associated with the user at the first location, the second measurements associated with the user at the second location (The citations above have established that the first sensor (e.g., implantable slave/master nodes), the second sensor (e.g., gateway node), and the host device (e.g., access point node) communicate with one another using both ultrasound and RF communication – this transferred data is the sensor data collected from each node, see p. 48, ll. 20-23 and p. 50, ll. 4-6) (physiological sensing “including cardiac rhythm, heart rate, pulse and blood pressure” p. 45, ll. 303-31);
(Claims 2 and 22) where the first sensor and second sensor (p. 12, ll. 18-10 “Each node comprises… one or more sensors…”) (pg. 12, ll. 9-12 “…measuring, storing, and delivering out-the-body vital biological parameters of the patient as measured by a variety of implantable sensors…”) obtain the first measurements comprising electrical measurements (ECG, p. 25, l. 32), acoustic measurements (ultrasonic networking operations, p. 25, l. 25), inertial measurements (accelerometer, p. 25, l. 32), or a combination thereof at the first and second locations (incorporate several sensors, p. 25, l. 31);
(Claims 3 and 25) wherein the physiological parameter comprises blood pressure of the user (blood pressure sensor, pg. 45, l. 31);
(Claims 5, 28 and 29 – Partial) where the respective sensor/host obtaining or transmitting the first and second measurements over the ultrasound/RF links established for Claims 1/27 above, the second sensor (gateway node) receiving the first measurements from the first sensor (implantable node) via ultrasound (p. 12, ll. 19-21) and performing RF data communication with the host device (access point node) to transmit the collected sensor data (Claim 5), the host device obtaining the data via wireless communication with the first sensor (Claim 28) and the first sensor obtaining the second measurements via wireless communication with the second sensor (p. 48, ll. 20-32; p. 49, ll. 16-17; p. 50, ll. 4-6, 18-24; p. 12, ll. 21-23, 26-27);
(Claim 6) wherein the host device comprises a mobile user device (Apple iPhone smart phone, p. 32, ll. 11),
(Claim 8) wherein the first sensor, the second sensor, or a combination thereof interface with a skin of the user via direct contact (p. 49, ll. 2-3 “…node[s] can be packaged such to offer a slim form factor that can be attached to stick-on skin patches.);
(Claims 10) wherein the acoustic communication comprises ultrasound communication; the first sensor comprises an ultrasound transmitter; and the second sensor comprises an ultrasound receiver receiving ultrasound signals (p. 12, ll. 19-23 “…nodes can communication through ultrasound… each comprising an ultrasonic device, deployed along the body of the patient.”);
(Claim 11) wherein the first sensor performs the acoustic communication with the second sensor via the ultrasound transmitter (p. 12, ll. 19-23 “…nodes can communication through ultrasound… each comprising an ultrasonic device, deployed along the body of the patient.” which implies all sensors have both a ultrasonic device and receiver, since they all communication with one another via ultrasound), and the second sensor performs the RF data communication with the host device (The citations above in Claims 1, 21, 27 and 30 have established that the first sensor (e.g., implantable slave/master nodes), the second sensor (e.g., gateway node), and the host device (e.g., access point node) communicate with one another using both ultrasound and RF communication – this transferred data is the sensor data collected from each node, see p. 48, ll. 20-23 and p. 50, ll. 4-6), at least a portion of the RF data communication with the host device comprising a transmission of one or more timestamps to the host device (p. 19, ll. 16-19 “Fine synchronization is achieved by correlating the received signal with a local copy of the preamble, i.e., a sequence that precedes each packet, which outputs a peak corresponding to the first sample of the packet.”);
(Claims 12 and 26) further comprising a third sensor (implantable slave and/or master nodes, page 21, lines 8-16, meaning multiple nodes are disclosed) disposed at a third location of the user (p. 12, ll. 19-21 “… nodes… deployed along the body of the patient.”) obtaining third measurements associated with the user at the third location (p. 12, ll. 18-10 “Each node comprises… one or more sensors…”) (pg. 12, ll. 9-12 “…measuring, storing, and delivering out-the-body vital biological parameters of the patient as measured by a variety of implantable sensors…”) wherein the ultrasound signals comprise broadband signals modulated using orthogonal frequency-division multiplexing (OFDM) (p. 14, ll. 22-24 “For example, two signaling schemes (GMSK and orthogonal frequency-division multiplexing (OFDM), discussed further below) can be suitably used because of their high spectral efficiency and resilience to multipath.”);
(Claim 13) wherein the second sensor or the host device determines the physiological parameter associated with the user based on the first measurements, the second measurements, and the third measurements (The citations above in Claims 1, 21, 27 and 30, in view of the understanding that there may be multiple nodes, has established that the first sensor and a third sensor (e.g., implantable slave/master nodes), alongside the second sensor (e.g., gateway node), and the host device (e.g., access point node), all communicate with one another using both ultrasound and RF communication – this transferred data is the sensor data collected from each node, see p. 48, ll. 20-23 and p. 50, ll. 4-6);
(Claims 14 and 23) wherein the first sensor and the second sensor each perform the RF data communication with the host device via a Bluetooth protocol (p. 50, ll. 4-5 “The RF chip can implement wireless short range or local area network communication standards, such as Bluetooth…”), at least a portion of the RF data communication comprising a temporal synchronization of a clock of the first sensor and a clock of the second sensor (p. 19, ll. 13-19, also see PN-sequence mode and Chirp-based modes that follow);
(Claim 15) further comprising a control system (e.g., microcontroller), wherein the control system determines the physiological parameter of the user (p. 2, ll. 30-33 “the core unit of one or both of the implantable node and the gateway node comprises a microcontroller unit and a field programmable gate array (FPGA) operative to execute communication, processing and networking tasks.”);
(Claim 16) wherein the control system resides in the second sensor or the host device (p. 2, ll. 30-33 “…the core unit of one or both of the implantable node and the gateway node comprises a microcontroller unit and a field programmable gate array (FPGA) operative to execute communication, processing and networking tasks.”);
(Claim 17 – Partial) further comprising a data interface communicating with a control system (e.g., microcontroller), the control system determining the physiological parameter of the user based on the first measurements, the second measurements (p. 2, ll. 30-33 “the core unit of one or both of the implantable node and the gateway node comprises a microcontroller unit and a field programmable gate array (FPGA) operative to execute communication, processing and networking tasks.”);
(Claim 18 – Partial) further comprising a third sensor (implantable slave and/or master nodes, page 21, lines 8-16, meaning multiple nodes are disclosed) disposed at a third location of the user (p. 12, ll. 19-21 “… nodes… deployed along the body of the patient.”) obtaining third measurements associated with the user at the third location (p. 12, ll. 18-10 “Each node comprises… one or more sensors…”) (pg. 12, ll. 9-12 “…measuring, storing, and delivering out-the-body vital biological parameters of the patient as measured by a variety of implantable sensors…”), the third sensor comprising an ultrasound transmitter (p. 12, ll. 19-23 “…nodes can communication through ultrasound… each comprising an ultrasonic device, deployed along the body of the patient.”); wherein the second sensor performs acoustic communication with the third sensor (p. 12, ll. 19-23 “…nodes can communication through ultrasound… each comprising an ultrasonic device, deployed along the body of the patient.” which implies all sensors have both a ultrasonic device and receiver, since they all communication with one another via ultrasound);
(Claim 19) wherein the second sensor further comprises an ultrasound receiver receiving ultrasound signals (p. 12, ll. 19-23 “…nodes can communication through ultrasound… each comprising an ultrasonic device, deployed along the body of the patient.”), the third sensor performs the acoustic communication with the second sensor via an ultrasound transmitter (p. 12, ll. 19-23 “…nodes can communication through ultrasound… each comprising an ultrasonic device, deployed along the body of the patient.” which implies all sensors have both a ultrasonic device and receiver, since they all communication with one another via ultrasound), and the second sensor performs the RF data communication with the host device (The citations above in Claims 1, 21, 27 and 30 have established that the first sensor (e.g., implantable slave/master nodes), the second sensor (e.g., gateway node), and the host device (e.g., access point node) communicate with one another using both ultrasound and RF communication – this transferred data is the sensor data collected from each node, see p. 48, ll. 20-23 and p. 50, ll. 4-6), at least a portion of the RF data communication with the host device comprising a transmission of one or more timestamps to the host device (p. 19, ll. 16-19 “Fine synchronization is achieved by correlating the received signal with a local copy of the preamble, i.e., a sequence that precedes each packet, which outputs a peak corresponding to the first sample of the packet.”),
(Claim 20) wherein the first sensor, the second sensor, and the third sensor perform the RF data communication with the host device via a Bluetooth protocol (p. 50, ll. 4-5 “The RF chip can implement wireless short range or local area network communication standards, such as Bluetooth…”), at least a portion of the RF data communication comprising a temporal synchronization of a clock of the first sensor, a clock of the second sensor, and a clock of the third sensor (p. 19, ll. 13-19, also see PN-sequence mode and Chirp-based modes that follow),
(Claim 24 – Partial) wherein the acoustic communication comprises transmitting an ultrasound signal between the first sensor and the second sensor (p. 12, ll. 19-21 “…nodes can communicate through ultrasound with one or more gateway nodes, each comprising an ultrasonic device…”) and the transmitting of the ultrasound signal between the first sensor and the second sensor occurs through tissue of the user (p. 49, ll. 12-16 “…node(s) can embed two arrays of miniaturized ultrasonic transducers that offer high integration, as well as focusing and beamforming capabilities that enhance the ultrasonic propagation in body tissues … coupled with the external medium to support communication in… body tissues…”).
Melodia discloses determining the location and the ability to track node location using ultrasonic transducers via acoustic localization and tracking functionalities (p. 13, ll. 30-33) but does not expressly disclose:
(Claims 1, 21, 27 and 29 – Partial) where the physiological parameter is determined based on a pulse wave velocity (PWV) of a blood vessel of the user, the PWV determined based on a pulse transit time (PTT) between the first location and the second location and the distance between the first location and the second location.
(Claims 5, 28 and 29 – Partial) wherein the second sensor further performs RF data communication with the host device to transmit the distance between the first location and the second location to the host device,
(Claim 17 – Partial) wherein the control system determines the physiological parameter of the user based the distance,
(Claim 18 – Partial) at least a portion of the acoustic communication with the third sensor determines, by the second sensor, of a distance between the second location and the third location; and the determination of the physiological parameter associated with the user is further based on the third measurements associated with the user at the third location and the distance between the second location and the third location, and
(Claim 24 – Partial) determining a distance between the first location and the second location based at least on the ultrasound signal.
Melodia discloses the claimed invention except for expressly disclosing and wherein the physiological parameter is determined based on a pulse wave velocity (PWV) of a blood vessel of the user, the PWV determined based on a pulse transit time (PTT) between the first location and the second location and the distance between the first location and the second location.
However, McCombie teaches a wearable, non-invasive arterial blood pressure monitoring device ([0002]). McCombie obtains measurements from two PPG sensors placed at spatially distinct locations along the same peripheral arterial branch ([0050]) and where a physiological parameter is determined based on a pulse wave velocity (PWV) of a blood vessel of the user ([0058] “The ability to utilize pulse wave velocity c to estimate arterial blood pressure P is based on the relationship that both the pulse wave velocity and arterial blood pressure shares with arterial vessel elasticity E.”), the PWV determined based on a pulse transit time (PTT) between the first location and the second location and the distance between the first location and the second location ([0055] “The transit time (Δt) between the two sensors of the propagating pressure wave is determined from the circulatory waveforms captured by the two in-line PPG sensors.”) ([0057] “The estimated peripheral pulse wave velocity c can then be determined from the measurements of pulse transit time Δt and pulse transit distance Δx as shown, according to: c=(Δx)/ Δt). (1)”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the synchronized sensor system of Melodia such that the physiological parameter is determined based on pulse wave velocity computed from pulse transit time between the first and second locations and the distance between the first and second locations, as taught by McCombie, as McCombie teaches this would have provided non-invasive, ambulatory arterial blood-pressure monitoring in a compact wearable form ([0003], [0048]). Melodia already provides the first and second body worn sensors, the acoustic communication that enables localization by which the inter-sensor distance is determined, and the RF link by which sensor data is communicated for physiological-parameter determination; applying McCombie’s known technique of deriving arterial blood pressure from pulse wave velocity (c = Δx/Δt) to Melodia’s system amounts to the use of a known technique to improve a similar devices, yielding the predictable results of a wearable network that reports the user’s blood pressure.
This combination teaches the remaining portions of entirety of Claims 1, 21, 24, 27 and 30.
(Claims 5, 18, 28 and 29) Since it has been previously established above in Claims 1, 21, 27 and 30 that the first sensor (e.g., implantable slave/master nodes), the second sensor (e.g., gateway node), and the host device (e.g., access point node) of Melodia communicate with one another using both ultrasound and RF communication, and Melodia further establishes there can be a multitude of sensors (e.g., more than 3 sensors and respective locations) the transferred RF data would have obviously also included the distance between first, second, and third locations to the host device as taught by Melodia, and has been previously established that McCombie determines the distance, it would have been obvious to include that the determined distance in the data communicated to/obtained by the host, since Melodia’s access point “connects the system to an external network, such as the Internet, enabling… remote monitoring… and cloud storage of data” (p. 12), where the distance-based physiological-parameter determined in is performed.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melodia in view of McCombie, and further in view of “Photoacoustic tomography and sensing in biomedicine” to Li et al. (hereinafter, Li).
Melodia in view of McCombie do not expressly disclose where the sensors are photoacoustic sensors, however, Li teaches in the Abstract that photoacoustic sensors can specifically used in biomedical applications because they provide a higher signal-to-noise ratio and permit direct detection of the distance through time resolve signals (see 2.1 Generation of PA signals), making such combination obvious to one having ordinary skill in the art. Such modification would have been simple substitution of one type of acoustic sensor for another.
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.
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/SEAN P DOUGHERTY/ Primary Examiner, Art Unit 3791
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