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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22-46 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites the limitation “when the sensor is positioned proximate the blood vessel, an aggregate ultrasonic image plane that encompasses a cross section of the blood vessel is scannable by the array of ultrasonic transducers” it is unclear what an aggregate ultrasonic image plane is and how it’s different from a known ultrasonic image plane. The examiner is interpreting the limitation as an ultrasonic image plane that encompasses a cross section of the blood vessel.
Claims 23-46 are rejected based on their dependency.
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.
Claim(s) 22-27 and 34-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rothberg et al. (US 2019/0069842).
Regarding claim 22, Rothberg teaches a system for monitoring a blood vessel of a patient, comprising (para. 0051; an ultrasound-on-a-chip device configured to be worn on a user's wrist):
a sensor including (para. 0052; The ultrasound module 104 includes an ultrasound-on-a-chip device 110 and an ultrasound housing element 128.):
a housing (para. 0052; The ultrasound module 104 includes an ultrasound-on-a-chip device 110 and an ultrasound housing element 128.);
a wireless transmitter (para. 0064; the ultrasound module 104 is configured to communicate with the primary module 102 wirelessly. In such embodiments, the ultrasound module 104 may include wireless communication circuitry configured to communicate wirelessly with the communication circuitry 116 of the primary module 102.);
an array of ultrasonic transducers attached to a first side of the housing (paras. 0053 and 0056; The ultrasound-on-a-chip device 110 includes micromachined ultrasound transducers integrated with a semiconductor die containing integrated ultrasound circuitry. The ultrasound-on-a-chip device 110 is positioned in the ultrasound module 104 such that its longitudinal axis is parallel to the longitudinal axis of the first wristband 106.);
a microcontroller in the housing connected to the array of ultrasonic transducers, wherein the array of ultrasonic transducers is arranged such that, when the sensor is positioned proximate the blood vessel, an aggregate ultrasonic image plane that encompasses a cross section of the blood vessel is scannable by the array of ultrasonic transducers (paras. 0060 and 0065; The ultrasound module 104 may include internal processing circuitry 112, memory circuitry 114, communication circuitry 116, and/or power management circuitry 118. The processing circuitry 112 may be configured to perform any of the functionality described herein. The processing circuitry 112 may include one or more processors (e.g., computer hardware processors) and may be configured to execute one or more processor-executable instructions stored in the memory circuitry 114. The processing circuitry 112 is configured to receive ultrasound data from the ultrasound-on-a-chip device 110 and includes image reconstructions circuitry for reconstructing the ultrasound data into an ultrasound image (which may be two-dimensional images or, when the ultrasound-on-a-chip device 110 includes a two-dimensional array, three-dimensional images). The processing circuitry 112 may also be configured to perform calculations (e.g., anatomical or physiological measurements) based on ultrasound data and/or ultrasound images (which may be two-dimensional images or, when the ultrasound-on-a-chip device 110 includes a two-dimensional array, three-dimensional images).), and
a user electronic device in communication with the wireless transmitter, wherein the user electronic device includes a display with a user interface and is configured to receive data from the sensor (paras. 0062 and 0065; the ultrasound module 104 may include internal processing circuitry 112, memory circuitry 114, communication circuitry 116, and/or power management circuitry 118. Portions of the circuitry may be integrated with the ultrasound-on-a-chip device 110. In such embodiments, the ultrasound module 104 may perform image reconstruction and/or data transmission to an external device using circuitry internal to the ultrasound module 104. The communication circuitry 116 is configured to wirelessly transmit data (e.g., ultrasound data, ultrasound images, calculations based on ultrasound data/images) to an external device, such as external host device, workstation, or server. The communication circuitry 116 may include BLUETOOTH, ZIGBEE, and/or WiFi wireless communication circuitry.).
Regarding claim 23, Rothberg teaches the system of claim 22, wherein the microcontroller includes a module configured to process signals representative of ultrasonic waveforms and convert the signals to image data (para. 0060; The processing circuitry 112 is configured to receive ultrasound data from the ultrasound-on-a-chip device 110 and includes image reconstructions circuitry for reconstructing the ultrasound data into an ultrasound image (which may be two-dimensional images or, when the ultrasound-on-a-chip device 110 includes a two-dimensional array, three-dimensional images). The processing circuitry 112 may also be configured to perform calculations (e.g., anatomical or physiological measurements) based on ultrasound data and/or ultrasound images (which may be two-dimensional images or, when the ultrasound-on-a-chip device 110 includes a two-dimensional array, three-dimensional images).).
Regarding claim 24, Rothberg teaches the system of claim 22, wherein the microcontroller includes a module configured to process signals representative of ultrasonic waveforms and convert the signals to a plurality of dimensional blood vessel parameters (paras. 0060 and 0108; The processing circuitry 112 is configured to receive ultrasound data from the ultrasound-on-a-chip device 110 and includes image reconstructions circuitry for reconstructing the ultrasound data into an ultrasound image (which may be two-dimensional images or, when the ultrasound-on-a-chip device 110 includes a two-dimensional array, three-dimensional images). The processing circuitry 112 may also be configured to perform calculations (e.g., anatomical or physiological measurements) based on ultrasound data and/or ultrasound images (which may be two-dimensional images or, when the ultrasound-on-a-chip device 110 includes a two-dimensional array, three-dimensional images).).
Regarding claim 25, Rothberg teaches the system of claim 23, wherein the module is configured to process the image data to determine a plurality of dimensional blood vessel parameters, the plurality of dimensional blood vessel parameters including a blood vessel diameter and a blood vessel area (paras. 0060, 0108, and 0114; The processing circuitry may perform various anatomical and physiological measurements using the ultrasound image, such as measuring the diameter of a blood vessel displayed in the ultrasound image; measuring the average, minimum, and/or maximum of the diameter over time of a blood vessel displayed in the ultrasound image; measuring blood pressure; measuring velocity of blood flow within a blood vessel displayed in the ultrasound image; producing a map of velocity of blood flow within a blood vessel; producing a time trace of heart rate; and producing a time trace of velocity of blood flow within a blood vessel displayed in the ultrasound image. By performing the transverse ultrasound scan of the blood vessel 1304, the set of ultrasound transducers 1308 may collect ultrasound data from which the diameter of the blood vessel 1304 can be measured. As discussed above, measuring the diameter of the blood vessel 1304 may be useful, for example, for calculating the cross-sectional area of the blood vessel 1304, which in turn can be useful for calculating PWV.).
Regarding claim 26, Rothberg teaches the system of claim 24, wherein the module is configured to determine a change in one or more of the plurality of dimensional blood vessel parameters over time (para. 0108; The processing circuitry may perform various anatomical and physiological measurements using the ultrasound image, such as measuring the diameter of a blood vessel displayed in the ultrasound image; measuring the average, minimum, and/or maximum of the diameter over time of a blood vessel displayed in the ultrasound image).
Regarding claim 27, Rothberg teaches the system of claim 22, wherein the user electronic device is configured to display content based on data received from the sensor (paras. 0062 and 0065; the ultrasound module 104 may include internal processing circuitry 112, memory circuitry 114, communication circuitry 116, and/or power management circuitry 118. Portions of the circuitry may be integrated with the ultrasound-on-a-chip device 110. In such embodiments, the ultrasound module 104 may perform image reconstruction and/or data transmission to an external device using circuitry internal to the ultrasound module 104. The communication circuitry 116 is configured to wirelessly transmit data (e.g., ultrasound data, ultrasound images, calculations based on ultrasound data/images) to an external device, such as external host device, workstation, or server. The communication circuitry 116 may include BLUETOOTH, ZIGBEE, and/or WiFi wireless communication circuitry.).
Regarding claim 34, Rothberg teaches the system of claim 22, wherein the sensor is configured to be attached to the skin of the patient (para. 0051; an ultrasound-on-a-chip device configured to be worn on a user's wrist).
Regarding claim 35, Rothberg teaches the system of claim 22, wherein the array of transducers includes a two dimensional grid of a plurality of transducer elements (para. 0054; he ultrasound transducers may be arranged in a one-dimensional array or a two-dimensional array, and there may be 1024, 2048, 4096, 8192, 16384, or any other suitable number of transducer elements in the array. The transducers may be arranged with a 50 μm, 100 μm, 130 μm, 200 μm, 250 μm, or any other suitable pitch.).
Regarding claim 36, Rothberg teaches the system of claim 34, wherein the housing includes a pad for attaching to skin, a locking plate attached to the pad, and an ultrasound transducer module containing the array of ultrasonic transducers, wherein the locking plate is configured to removably receive the ultrasound transducer module (fig. 1, element 148, paras. 0058-0059; the ultrasound housing element 128 and the first wristband 106 enclose the ultrasound-on-a-chip device 110. The ultrasound housing element 128 has an acoustic lens 146 through which ultrasonic waves can propagate from the ultrasound-on-a-chip device 110 into the user's wrist. In some embodiments, the acoustic lens 146 is a simple opening in the ultrasound housing element 128. When the apparatus 100 is assembled, the ultrasound housing element 128 faces the user's wrist. In some embodiments, the ultrasound housing element 128 is a protrusion from the first wristband 106 that forms a cavity that contains the ultrasound-on-a-chip device 110. The coupling strip 148 is attached to the surface of the acoustic lens 146 that faces the user's wrist. The coupling strip 148 is configured to reduce the air gap between the ultrasound module 104 and the user's wrist and to establish acceptable impedance matching coupling for ultrasound signal transmission and reception. The examiner notes that the locking plate is the ultrasound housing that has the ultrasonic lens and the coupling strip and is configured to receive the ultrasound on a chip device.).
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.
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.
Claim(s) 28-31, 33, and 41-46 are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg et al. (US 2019/0069842) in the view of Deem et al. (WO 2018/031714).
Regarding claim 28, Rothberg teaches the system of claim 24, however, fails to explicitly teach wherein the microcontroller includes an euvolemic module configured to compare a blood vessel diameter value to a range of diameter threshold values and compare a blood vessel area value to a range of threshold area values.
Deem, in the same field of endeavor, teaches a microcontroller includes an euvolemic module configured to compare a blood vessel diameter value to a range of diameter threshold values and compare a blood vessel area value to a range of threshold area values (paras. 0022-0023; a diagnostic approach based on IVC diameter or area measurement across the respiratory and/or cardiac cycles (Ai and A.sub.2), which correlates directly to r C volume and IVC CI (hereinafter "IVC Volume Metrics") provides relatively consistent information on patient fluid state across the full range of states. Using IVC diameter or area measurement as an indicator of patient fluid volume as disclosed herein thus provides an opportunity for earlier response both as a hypovolemic warning and as an earlier hypervolemic warning. With respect to hypovolemia, when using pressure as a monitoring tool, a high pressure threshold can act as a potential sign of congestion, however when pressure is below a pressure threshold (i.e., along the flat part of curve B), it gives no information about the fluid status as the patient approaches hypovolemia. With respect to hypervolemia, IVC diameter or area measurements potentially provide an earlier signal than pressure-based signals due to the fact that IVC diameter or area measurements change a relatively large amount without significant change in pressure. Hence, a threshold set on IVC diameter or area measurements can give an earlier indication of hypervolemia, in advance of a pressure-based signal.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the system of Rothberg to incorporate the teaching of Deem to include a an euvolemic module configured to compare a blood vessel diameter value to a range of diameter threshold values and compare a blood vessel area value to a range of threshold area values. Doing so would help in providing the ability to define early warning zones as such based on IVC diameter or area measurements means that appropriate interventions may be initiated earlier, before the patient reaches higher levels of criticality, and thus also may be controlled more precisely and smoothly to minimize risk of shock from sudden interventions and/or overshoot of therapy targets as disclosed within Deem in paras. 0024.
Regarding claim 29, Rothberg teaches the system of claim 28, however, fails to explicitly teach wherein the euvolemic module is configured to transmit a warning signal to the user electronic device when the blood vessel diameter value and/or the blood vessel area value are determined to be in ranges associated with a hypervolemic state or a hypovolemic state for the patient.
Deem, in the same field of endeavor, teaches wherein the euvolemic module is configured to transmit a warning signal to the user electronic device when the blood vessel diameter value and/or the blood vessel area value are determined to be in ranges associated with a hypervolemic state or a hypovolemic state for the patient (paras. 0022-0023; a diagnostic approach based on IVC diameter or area measurement across the respiratory and/or cardiac cycles (Ai and A.sub.2), which correlates directly to r C volume and IVC CI (hereinafter "IVC Volume Metrics") provides relatively consistent information on patient fluid state across the full range of states. Using IVC diameter or area measurement as an indicator of patient fluid volume as disclosed herein thus provides an opportunity for earlier response both as a hypovolemic warning and as an earlier hypervolemic warning. With respect to hypovolemia, when using pressure as a monitoring tool, a high pressure threshold can act as a potential sign of congestion, however when pressure is below a pressure threshold (i.e., along the flat part of curve B), it gives no information about the fluid status as the patient approaches hypovolemia. With respect to hypervolemia, IVC diameter or area measurements potentially provide an earlier signal than pressure-based signals due to the fact that IVC diameter or area measurements change a relatively large amount without significant change in pressure. Hence, a threshold set on IVC diameter or area measurements can give an earlier indication of hypervolemia, in advance of a pressure-based signal.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the system of Rothberg to incorporate the teaching of Deem to include a an euvolemic module configured to compare a blood vessel diameter value to a range of diameter threshold values and compare a blood vessel area value to a range of threshold area values and transmit a warning signal to the user electronic device. Doing so would help in providing the ability to define early warning zones as such based on IVC diameter or area measurements means that appropriate interventions may be initiated earlier, before the patient reaches higher levels of criticality, and thus also may be controlled more precisely and smoothly to minimize risk of shock from sudden interventions and/or overshoot of therapy targets as disclosed within Deem in paras. 0024.
Regarding claim 30, Rothberg teaches the system of claim 22, however, fails to explicitly teach wherein the sensor is configured to be implanted subcutaneously.
Deem, in the same field of endeavor, teaches wherein the sensor is configured to be implanted subcutaneously (paras. 0060; implant 12a, shown in FIG. 12, is an ultrasound-based device. As shown therein, 12a comprises three major components or assemblies, electronics capsule 120, anchor element 122 and anchor isolation structure 124 connecting the electronics capsule and anchor element. Electronics capsule 120 comprises a sealed housing 126 for containing control, power and other alternative functional modules as elsewhere described herein to provide a self-contained, sealed device. Capsule 120 also provides support for marker element 128, which in the case of implant 12a is a single ultrasound marker element positioned at the inferior end of the device. Such a marker element may utilize one or more ultrasound crystals to measure IVC diameter by emitting an ultrasound pulse, and then detecting the reflection of that pulse from the opposing wall of the IVC.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the ultrasound on chip device of Rothberg to incorporate the teaching of Deem to include an implantable ultrasound wireless sensor. Doing so would provide in insuring proper and consistent positioning of the sensing device relative to the region of interest by implanting and anchoring the sensor relative to the blood vessel for accurate prediction of fluid state. Additionally, the use of implantable devices makes is more practical for use as long term diagnostic tool for regular (e.g. daily) monitoring of patients who are not hospitalized as disclosed within Deem in para. 0006.
Regarding claim 31, Rothberg teaches the system of claim 30, wherein the array of ultrasonic transducers includes a plurality of transducer elements, wherein each of the plurality of transducer elements is attached to the first side of the housing, and wherein the first side of the housing is curved in one plane and, the first side faces the blood vessel (fig. 6A, para. 0058; The ultrasound housing element 128 and the first wristband 106 enclose the ultrasound-on-a-chip device 110. The ultrasound housing element 128 has an acoustic lens 146 through which ultrasonic waves can propagate from the ultrasound-on-a-chip device 110 into the user's wrist. In some embodiments, the acoustic lens 146 is a simple opening in the ultrasound housing element 128.).
However, Rothberg fails to explicitly teach that the sensor is implanted proximate the blood vessel.
Deem, in the same field of endeavor, teaches wherein the sensor is implanted proximate the blood vessel (paras. 0060; implant 12a, shown in FIG. 12, is an ultrasound-based device. As shown therein, 12a comprises three major components or assemblies, electronics capsule 120, anchor element 122 and anchor isolation structure 124 connecting the electronics capsule and anchor element. Electronics capsule 120 comprises a sealed housing 126 for containing control, power and other alternative functional modules as elsewhere described herein to provide a self-contained, sealed device. Capsule 120 also provides support for marker element 128, which in the case of implant 12a is a single ultrasound marker element positioned at the inferior end of the device. Such a marker element may utilize one or more ultrasound crystals to measure IVC diameter by emitting an ultrasound pulse, and then detecting the reflection of that pulse from the opposing wall of the IVC.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the ultrasound on chip device of Rothberg to incorporate the teaching of Deem to include an implantable ultrasound wireless sensor. Doing so would provide in insuring proper and consistent positioning of the sensing device relative to the region of interest by implanting and anchoring the sensor relative to the blood vessel for accurate prediction of fluid state. Additionally, the use of implantable devices makes is more practical for use as long term diagnostic tool for regular (e.g. daily) monitoring of patients who are not hospitalized as disclosed within Deem in para. 0006.
Regarding claim 33, Rothberg teaches the system of claim 30, wherein the array of ultrasonic transducers includes a plurality of transducer elements, wherein each of the plurality of transducer elements is attached to the first side of the housing, wherein each of the plurality of transducer elements is configured to emit a beam profile having a narrowed portion, and wherein the narrowed portion is formed at a distance from the first side of the housing such that the narrowed portion is positioned near a central longitudinal axis of the blood vessel when the device is attached to or implanted in the patient (fig. 13, para. 0114; The blood vessel 1304 has a longitudinal axis 1306. The two-dimensional array of ultrasound transducers 1302 includes a set of ultrasound transducers 1308. In FIG. 13, the set of ultrasound transducers 1308 represents a column of the two-dimensional array of ultrasound transducers 1302. The set of ultrasound transducers 1308 is configured to perform a transverse ultrasound scan of the blood vessel 1304 by producing an ultrasound beam profile 1314 along a plane that is orthogonal to the longitudinal axis 1306 of the blood vessel 1304.).
Regarding claim 39, Rothberg teaches the system of claim 30, however, fails to explicitly teach wherein the sensor includes one or more protuberances extending from the housing and sized and configured to reduce rotation within subcutaneous space.
Deem, in the same field of endeavor, teaches wherein the sensor is implanted proximate the blood vessel (paras. 0009 and 0060; implant 12a, shown in FIG. 12, is an ultrasound-based device. As shown therein, 12a comprises three major components or assemblies, electronics capsule 120, anchor element 122 and anchor isolation structure 124 connecting the electronics capsule and anchor element. Electronics capsule 120 comprises a sealed housing 126 for containing control, power and other alternative functional modules as elsewhere described herein to provide a self-contained, sealed device. Capsule 120 also provides support for marker element 128, which in the case of implant 12a is a single ultrasound marker element positioned at the inferior end of the device. Such a marker element may utilize one or more ultrasound crystals to measure IVC diameter by emitting an ultrasound pulse, and then detecting the reflection of that pulse from the opposing wall of the IVC. the wireless sensing device may comprise an ultrasound transducer and anchor element configured to anchor the ultrasound transducer in the IVC in a fixed position relative to the IVC wall.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the ultrasound on chip device of Rothberg to incorporate the teaching of Deem to include an implantable ultrasound wireless sensor. Doing so would provide in insuring proper and consistent positioning of the sensing device relative to the region of interest by implanting and anchoring the sensor relative to the blood vessel for accurate prediction of fluid state. Additionally, the use of implantable devices makes is more practical for use as long term diagnostic tool for regular (e.g. daily) monitoring of patients who are not hospitalized as disclosed within Deem in para. 0006.
Regarding claim 41, Rothberg teaches the system of claim 25, however, fails to explicitly teach wherein the microcontroller includes a comparison module configured to compare the blood vessel area to a range of threshold area values for the patient and the blood vessel diameter to a range of threshold diameter values for the patient.
Deem, in the same field of endeavor, teaches microcontroller includes a comparison module configured to compare the blood vessel area to a range of threshold area values for the patient and the blood vessel diameter to a range of threshold diameter values for the patient (paras. 0022-0023; a diagnostic approach based on IVC diameter or area measurement across the respiratory and/or cardiac cycles (Ai and A.sub.2), which correlates directly to r C volume and IVC CI (hereinafter "IVC Volume Metrics") provides relatively consistent information on patient fluid state across the full range of states. Using IVC diameter or area measurement as an indicator of patient fluid volume as disclosed herein thus provides an opportunity for earlier response both as a hypovolemic warning and as an earlier hypervolemic warning. With respect to hypovolemia, when using pressure as a monitoring tool, a high pressure threshold can act as a potential sign of congestion, however when pressure is below a pressure threshold (i.e., along the flat part of curve B), it gives no information about the fluid status as the patient approaches hypovolemia. With respect to hypervolemia, IVC diameter or area measurements potentially provide an earlier signal than pressure-based signals due to the fact that IVC diameter or area measurements change a relatively large amount without significant change in pressure. Hence, a threshold set on IVC diameter or area measurements can give an earlier indication of hypervolemia, in advance of a pressure-based signal.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the system of Rothberg to incorporate the teaching of Deem to include a comparison module configured to compare the blood vessel area to a range of threshold area values for the patient and the blood vessel diameter to a range of threshold diameter values for the patient. Doing so would help in providing the ability to define early warning zones as such based on IVC diameter or area measurements means that appropriate interventions may be initiated earlier, before the patient reaches higher levels of criticality, and thus also may be controlled more precisely and smoothly to minimize risk of shock from sudden interventions and/or overshoot of therapy targets as disclosed within Deem in paras. 0024.
Regarding claim 42, Rothberg teaches the system of claim 41, however, fails to explicitly teach wherein the comparison module is configured to send instructions to send a warning to the user electronic device if the area is determined to be within a hypervolemic range of threshold area values, if the diameter is determined to be within a hypervolemic range of threshold diameter values, if the area is determined to be within a hypovolemic range of threshold area values, or if the diameter is determined to be within a hypovolemic range of threshold diameter values.
Deem, in the same field of endeavor, teaches the comparison module is configured to send instructions to send a warning to the user electronic device if the area is determined to be within a hypervolemic range of threshold area values, if the diameter is determined to be within a hypervolemic range of threshold diameter values, if the area is determined to be within a hypovolemic range of threshold area values, or if the diameter is determined to be within a hypovolemic range of threshold diameter values (paras. 0022-0023; a diagnostic approach based on IVC diameter or area measurement across the respiratory and/or cardiac cycles (Ai and A.sub.2), which correlates directly to r C volume and IVC CI (hereinafter "IVC Volume Metrics") provides relatively consistent information on patient fluid state across the full range of states. Using IVC diameter or area measurement as an indicator of patient fluid volume as disclosed herein thus provides an opportunity for earlier response both as a hypovolemic warning and as an earlier hypervolemic warning. With respect to hypovolemia, when using pressure as a monitoring tool, a high pressure threshold can act as a potential sign of congestion, however when pressure is below a pressure threshold (i.e., along the flat part of curve B), it gives no information about the fluid status as the patient approaches hypovolemia. With respect to hypervolemia, IVC diameter or area measurements potentially provide an earlier signal than pressure-based signals due to the fact that IVC diameter or area measurements change a relatively large amount without significant change in pressure. Hence, a threshold set on IVC diameter or area measurements can give an earlier indication of hypervolemia, in advance of a pressure-based signal.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the system of Rothberg to incorporate the teaching of Deem to include a comparison module configured to compare the blood vessel area to a range of threshold area values for the patient and the blood vessel diameter to a range of threshold diameter values for the patient and transmit a warning to the user. Doing so would help in providing the ability to define early warning zones as such based on IVC diameter or area measurements means that appropriate interventions may be initiated earlier, before the patient reaches higher levels of criticality, and thus also may be controlled more precisely and smoothly to minimize risk of shock from sudden interventions and/or overshoot of therapy targets as disclosed within Deem in paras. 0024.
Regarding claim 43, Rothberg teaches the system of claim 42, however, fails to explicitly teach wherein the comparison module is configured to determine whether the patient is in a hypovolemic state, a euvolemic state, or a hypervolemic state based on the area and the diameter.
Deem, in the same field of endeavor, teaches wherein the comparison module is configured to determine whether the patient is in a hypovolemic state, a euvolemic state, or a hypervolemic state based on the area and the diameter (paras. 0022-0023; a diagnostic approach based on IVC diameter or area measurement across the respiratory and/or cardiac cycles (Ai and A.sub.2), which correlates directly to r C volume and IVC CI (hereinafter "IVC Volume Metrics") provides relatively consistent information on patient fluid state across the full range of states. Using IVC diameter or area measurement as an indicator of patient fluid volume as disclosed herein thus provides an opportunity for earlier response both as a hypovolemic warning and as an earlier hypervolemic warning. With respect to hypovolemia, when using pressure as a monitoring tool, a high pressure threshold can act as a potential sign of congestion, however when pressure is below a pressure threshold (i.e., along the flat part of curve B), it gives no information about the fluid status as the patient approaches hypovolemia. With respect to hypervolemia, IVC diameter or area measurements potentially provide an earlier signal than pressure-based signals due to the fact that IVC diameter or area measurements change a relatively large amount without significant change in pressure. Hence, a threshold set on IVC diameter or area measurements can give an earlier indication of hypervolemia, in advance of a pressure-based signal.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the system of Rothberg to incorporate the teaching of Deem to include a wherein the comparison module is configured to determine whether the patient is in a hypovolemic state, a euvolemic state, or a hypervolemic state based on the area and the diameter. Doing so would help in providing the ability to define early warning zones as such based on IVC diameter or area measurements means that appropriate interventions may be initiated earlier, before the patient reaches higher levels of criticality, and thus also may be controlled more precisely and smoothly to minimize risk of shock from sudden interventions and/or overshoot of therapy targets as disclosed within Deem in paras. 0024.
Regarding claim 44, Rothberg teaches the system of claim 42, however, fails to explicitly teach wherein the warning includes a prompt to initiate a treatment or medication change based on whether the patient is determined to be in a hypovolemic state, a euvolemic state, or a hypervolemic state.
Deem, in the same field of endeavor, teaches wherein a prompt to initiate a treatment or medication change based on whether the patient is determined to be in a hypovolemic state, a euvolemic state, or a hypervolemic state (paras. 0036 and 0050; a system employing an implanted IVC diameter/area monitoring device, workflow 70 may include, for example, after device implantation 72, an initial detection algorithm that calls for periodic readings 74 of IVC diameter/area when the patient is at home. Such periodic readings may, for example, be taken weekly, daily or on other appropriate periods as determined by the healthcare provider based on patient parameters. In some embodiments the reading may be taken with the patient lying supine in bed and in proximity to a bedside console. Alternatively, the IVC diameter/area monitoring implant may include on-board memory, in which case it may also monitor IVC diameter or area measurements continuously or every few minutes and record the readings over the course of a day, and transmit once a day. Trend data for the selected period could be developed in this manner. Readings may be transmitted through the communications network as established to the clinical interface 76. Based on IVC metrics, i.e., blood volume as determined in the clinical interface, the treatment algorithm determines necessary interventions if any. When conditions or trends are indicated within predetermined "normal" parameters for the specific patient, no action 82 is indicated and the system resets for the next periodic reading 74. However, if a condition or trend is indicated outside of the predetermined "normal" parameters, a clinical alert 84 may be generated and suggested interventions established by the applicable treatment algorithm employed. For example, in response to clinical alert 84, the healthcare provider directed care 86 or patient self-directed care 88 may be considered as suggested interventions and one or more effected consistent with the patient treatment plan. For patients already in a clinical setting, this may include instructions to other treatment devices connected to or working with the patient (for example, as shown in FIG. 6A with system 10). control modules, which may include treatment algorithms as described herein for determining treatment protocols based on collected IVC diameter or area measurements, and systems for automated remote control of treatment devices based on determined treatment protocols as elsewhere described herein. Examples of such treatment devices include, but are not limited to, dialysis machine 34 and drug delivery devices 36. Examples of treatments include, when measured dimensions fall within the hypovolemic warning zone, administration of fluids or vaso-constricting drugs, and when measured dimensions fall within the hypervolemic warning zone, dialysis or administration of diuretics or vasodilating drugs.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the system of Rothberg to incorporate the teaching of Deem to include a prompt to initiate a treatment or medication change based on whether the patient is determined to be in a hypovolemic state, a euvolemic state, or a hypervolemic state. Doing so would help in providing the ability to define early warning zones as such based on IVC diameter or area measurements means that appropriate interventions may be initiated earlier, before the patient reaches higher levels of criticality, and thus also may be controlled more precisely and smoothly to minimize risk of shock from sudden interventions and/or overshoot of therapy targets as disclosed within Deem in paras. 0024.
Regarding claim 45, Rothberg teaches the system of claim 44, however, fails to explicitly teach wherein, when the patient is determined to be in the hypovolemic state, the treatment or medication change includes a recommendation for administration of fluids or vaso-constricting drugs.
Deem, in the same field of endeavor, teaches the patient is determined to be in the hypovolemic state, the treatment or medication change includes a recommendation for administration of fluids or vaso-constricting drugs (paras. 0036 and 0050; a system employing an implanted IVC diameter/area monitoring device, workflow 70 may include, for example, after device implantation 72, an initial detection algorithm that calls for periodic readings 74 of IVC diameter/area when the patient is at home. Such periodic readings may, for example, be taken weekly, daily or on other appropriate periods as determined by the healthcare provider based on patient parameters. In some embodiments the reading may be taken with the patient lying supine in bed and in proximity to a bedside console. Alternatively, the IVC diameter/area monitoring implant may include on-board memory, in which case it may also monitor IVC diameter or area measurements continuously or every few minutes and record the readings over the course of a day, and transmit once a day. Trend data for the selected period could be developed in this manner. Readings may be transmitted through the communications network as established to the clinical interface 76. Based on IVC metrics, i.e., blood volume as determined in the clinical interface, the treatment algorithm determines necessary interventions if any. When conditions or trends are indicated within predetermined "normal" parameters for the specific patient, no action 82 is indicated and the system resets for the next periodic reading 74. However, if a condition or trend is indicated outside of the predetermined "normal" parameters, a clinical alert 84 may be generated and suggested interventions established by the applicable treatment algorithm employed. For example, in response to clinical alert 84, the healthcare provider directed care 86 or patient self-directed care 88 may be considered as suggested interventions and one or more effected consistent with the patient treatment plan. For patients already in a clinical setting, this may include instructions to other treatment devices connected to or working with the patient (for example, as shown in FIG. 6A with system 10). control modules, which may include treatment algorithms as described herein for determining treatment protocols based on collected IVC diameter or area measurements, and systems for automated remote control of treatment devices based on determined treatment protocols as elsewhere described herein. Examples of such treatment devices include, but are not limited to, dialysis machine 34 and drug delivery devices 36. Examples of treatments include, when measured dimensions fall within the hypovolemic warning zone, administration of fluids or vaso-constricting drugs, and when measured dimensions fall within the hypervolemic warning zone, dialysis or administration of diuretics or vasodilating drugs.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the system of Rothberg to incorporate the teaching of Deem to include a prompt to initiate a treatment or medication change based on whether the patient is determined to be in a hypovolemic state, a euvolemic state, or a hypervolemic state. Doing so would help in providing the ability to define early warning zones as such based on IVC diameter or area measurements means that appropriate interventions may be initiated earlier, before the patient reaches higher levels of criticality, and thus also may be controlled more precisely and smoothly to minimize risk of shock from sudden interventions and/or overshoot of therapy targets as disclosed within Deem in paras. 0024.
Regarding claim 46, Rothberg teaches the system of claim 44, however, fails to explicitly teach wherein, when the patient is determined to be in the hypovolemic state, the treatment or medication change includes a recommendation for dialysis or administration or treatment guidance for diuretics or vasodilating drugs.
Deem, in the same field of endeavor, teaches when the patient is determined to be in the hypovolemic state, the treatment or medication change includes a recommendation for dialysis or administration or treatment guidance for diuretics or vasodilating drugs (paras. 0036 and 0050; a system employing an implanted IVC diameter/area monitoring device, workflow 70 may include, for example, after device implantation 72, an initial detection algorithm that calls for periodic readings 74 of IVC diameter/area when the patient is at home. Such periodic readings may, for example, be taken weekly, daily or on other appropriate periods as determined by the healthcare provider based on patient parameters. In some embodiments the reading may be taken with the patient lying supine in bed and in proximity to a bedside console. Alternatively, the IVC diameter/area monitoring implant may include on-board memory, in which case it may also monitor IVC diameter or area measurements continuously or every few minutes and record the readings over the course of a day, and transmit once a day. Trend data for the selected period could be developed in this manner. Readings may be transmitted through the communications network as established to the clinical interface 76. Based on IVC metrics, i.e., blood volume as determined in the clinical interface, the treatment algorithm determines necessary interventions if any. When conditions or trends are indicated within predetermined "normal" parameters for the specific patient, no action 82 is indicated and the system resets for the next periodic reading 74. However, if a condition or trend is indicated outside of the predetermined "normal" parameters, a clinical alert 84 may be generated and suggested interventions established by the applicable treatment algorithm employed. For example, in response to clinical alert 84, the healthcare provider directed care 86 or patient self-directed care 88 may be considered as suggested interventions and one or more effected consistent with the patient treatment plan. For patients already in a clinical setting, this may include instructions to other treatment devices connected to or working with the patient (for example, as shown in FIG. 6A with system 10). control modules, which may include treatment algorithms as described herein for determining treatment protocols based on collected IVC diameter or area measurements, and systems for automated remote control of treatment devices based on determined treatment protocols as elsewhere described herein. Examples of such treatment devices include, but are not limited to, dialysis machine 34 and drug delivery devices 36. Examples of treatments include, when measured dimensions fall within the hypovolemic warning zone, administration of fluids or vaso-constricting drugs, and when measured dimensions fall within the hypervolemic warning zone, dialysis or administration of diuretics or vasodilating drugs.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the system of Rothberg to incorporate the teaching of Deem to include a prompt to initiate a treatment or medication change based on whether the patient is determined to be in a hypovolemic state, a euvolemic state, or a hypervolemic state. Doing so would help in providing the ability to define early warning zones as such based on IVC diameter or area measurements means that appropriate interventions may be initiated earlier, before the patient reaches higher levels of criticality, and thus also may be controlled more precisely and smoothly to minimize risk of shock from sudden interventions and/or overshoot of therapy targets as disclosed within Deem in paras. 0024.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Rothberg et al. (US 2019/0069842) in the view of Deem et al. (WO 2018/031714) and in further view of Bappoo et al. (WO 2022/221913, however the US version US 2024/0180523 is used for examination purposes).
Regarding claim 32, modified Rothberg teaches the system of claim 30, however, fails to explicitly teach wherein the array of ultrasonic transducers includes a plurality of transducer elements, wherein each of the plurality of transducer elements is attached to the first side of the housing, and wherein one or more of the plurality of transducer elements is positioned at an acute angle with respect to a plane of the first side of the housing, and when the sensor is implanted proximate the blood vessel, the first side faces the blood vessel.
Bappoo, in the same field of endeavor, teaches array of ultrasonic transducers includes a plurality of transducer elements, wherein each of the plurality of transducer elements is attached to the first side of the housing, and wherein one or more of the plurality of transducer elements is positioned at an acute angle with respect to a plane of the first side of the housing (para. 0119; The parallel transducer arrays 300A are angled at an angle of insonation ϕ where 10<ϕ<60, as shown in FIG. 3b. The angled configuration, being fixed, also saves the user from requiring to manually adjust the operating field of view and imaging angles. In this example, parallel transducer arrays 300A are separated by a distance ξ along the horizontal axis 309, chosen to minimize interference and maximize the scanning window 708. ξ may, as described above, be in the range of 5-30 mm. In this embodiment, a 15 mm spacing is provided between each parallel array 300. This would cover a region of interest 45 mm. A spacing above 30 mm would make the portable ultrasound device 109 larger than desirable for use in a cannulation procedure).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the ultrasound on chip device of Rothberg in the view of Deem to incorporate the teaching of Bappoo to include a plurality of transducer elements is positioned at an acute angle with respect to a plane of the first side of the housing. Doing so would eliminate the need to manually adjust the operating field of view and imaging angles as disclosed within Bappoo in para. 0119.
Claims 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg et al. (US 2019/0069842) in the view of Deem et al. (WO 2018/031714) and in further view of Gifford et al. (US 2019/0029639).
Regarding claim 37, modified Rothberg teaches the system of claim 30, however, fails to explicitly disclose wherein the sensor includes a sensing electrode on the housing configured to detect sympathetic nervous signals.
Gifford, in the same field of endeavor, disclose wherein the sensor includes a sensing electrode on the housing configured to detect sympathetic nervous signals (para. 0199; electrodes can be placed on the IVC element itself and/or on the leads leading to the device, in order to monitor, record, and communicate the heart's electrical activity.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the sensor of Rothberg in the view of Deem to incorporate the teaching of Gifford to include a sensing electrode on the housing configured to detect sympathetic nervous signals. Doing so would help in monitoring the patient’s heart electrical activity as disclosed within Gifford in para. 0199.
Regarding claim 38, modified Rothberg teaches the system of claim 30, however, fails to explicitly disclose wherein the sensor includes a pair of electrodes on the housing configured to detect tone by impedance between the pair of electrodes.
Gifford, in the same field of endeavor, disclose wherein the sensor includes a pair of electrodes on the housing configured to detect tone by impedance between the pair of electrodes (para. 0088; In an embodiment where the market elements are comprised of electrodes, it may be most effective to determine which electrodes are positioned most directly on the anterior and posterior walls, and to measure the variation in impedance between those electrodes. Alternatively, the system could measure the impedance from each electrode to each of the others, and to use the variation in impedances to estimate the change in shape. ).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the sensor of Rothberg in the view of Deem to incorporate the teaching of Gifford to include a pair of electrodes on the housing configured to detect tone by impedance between the pair of electrodes. Doing so would help in accurate estimation of change in shape of the vessel as disclosed within Gifford in para. 0088.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Rothberg et al. (US 2019/0069842) in the view of Bappoo et al. (WO 2022/221913, however the US version US 2024/0180523 is used for examination purposes).
Regarding claim 40, Rothberg teaches the system of claim 22, however, fails to explicitly teach wherein the housing contains a digital analog converter, a high voltage transmit amplifier, a multiplexer element, a transmit/receive switch, a time gain compensation amplifier, an analog digital converter, and a data buffer.
Bappoo, in the same field of endeavor, teaches wherein the housing contains a digital analog converter, a high voltage transmit amplifier, a multiplexer element, a transmit/receive switch, a time gain compensation amplifier, an analog digital converter, and a data buffer (paras. 0109-0112; a Field Programmable Gated Array 205, within controller block 250 which acts as a microcontroller for portable ultrasound device 109 and stores and generates pre-programmed digital signals containing ultrasonic oscillation settings, which is in turn converted to an analogue signal using a Digital to Analogue Converter (DAC) 204 and filtered for noise 203. In this embodiment, the filtered signal is sent to an ultrasonic waveform oscillator 201 which generates and transmits a primed signal to a diplexer 200 for frequency-domain multiplexing. It will be understood that FPGA 205 can be replaced with a chip-based controller, such as an ASIC chip based controller and there may be other acceptable alternatives. In this embodiment, the ultrasonic waveform oscillator 201 can be powered by a high-voltage power source 202 which can be toggled on or off using the user interface 105. The array of transducer elements 102 thus transmits and receives ultrasonic signals at the pre-determined frequencies, say in the range 3 to 8 MHz with 7 MHz being selected here (this comparing with the wide frequency range 2 to 18 MHz for typical diagnostic sonographic scanners. Received signals from transducer crystal array 102 are amplified using a low noise amplifier 207, filtered 203 and returned to the FPGA microcontroller 205 as a digital signal using an Analogue Digital Converter (ADC) 206. The received signals are processed onboard the portable ultrasound device 109 by processor block 210 using digital instructions or algorithms described below).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the system of Rothberg to incorporate the teaching of Bappoo to include a digital analog converter, a high voltage transmit amplifier, a multiplexer element, a transmit/receive switch, a time gain compensation amplifier, an analog digital converter, and a data buffer. Doing so would help in controlling and processing transmission and receival of ultrasonic waves from transducer crystal array as disclosed within Bappoo in para. 0108.
Conclusion
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/ZAINAB MOHAMMED ALDARRAJI/ Patent Examiner, Art Unit 3797
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