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 .
Status of Claims
Claims 1-13 are hereby under examination.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 07/26/2023 has been considered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 105. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because pages 4-7 of the drawings contain the International Search Report. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of the terms “Bluetooth” and “Wi-Fi”, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 7 is objected to because of the following informalities: "any of claims 1 to 6" should be deleted. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: "which forms at least forming part" should read "which forms at least part". Appropriate correction is required.
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.
Claim 2 is 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.
Regarding Claim 2, the claim recites “the electrical impedance”. There is insufficient antecedent basis for this claim limitation. Therefore, claim 2 is rendered indefinite. For the purposes of examination, “the electrical impedance” is herein interpreted to be “an electrical impedance”.
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.
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, 7, and 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (US Patent Pub. No. 20170340393 – cited by Applicant) hereinafter Choi in view of Kokate et al. (US Patent Pub. No. 20030125637 – cited by Applicant) hereinafter Kokate, in view of Shusterman (US Patent Pub. No. 20180020931), in view of Carney et al. (US Patent Pub. No. 20040243022) hereinafter Carney, and further in view of Johnson et al. (US Patent Pub. No 20180235470) hereinafter Johnson.
Regarding Claim 1, Choi discloses a system for predicting an at least partial rupture or a detachment of vascular plaque that could lead to a stroke (The hemodynamic characteristics may be used to predict cardiac events, including plaque rupture [0029]), with said vascular plaque being present on an arterial wall selected from among a carotid wall and a supra-aortic trunk wall (the same system is applicable to creating a patient-specific prediction of rupture risks in other vascular systems beyond the coronary arteries, such as the carotid artery [0028]), said system comprising:
a monitoring device able to be placed in a vicinity of the vascular plaque (obtaining a hemodynamic feature of the patient from a hemodynamic sensor (claim 21)), said monitoring device configured to:
measure movement of the arterial wall and movement of the vascular plaque (Coronary flow simulations with respect to patient physiological information and estimated boundary conditions may then be performed on the model to extract hemodynamic characteristics. The hemodynamic characteristics may be used to predict cardiac events, including plaque rupture and/or myocardial infarction. [0029]; performing flow dynamics and structural mechanics simulations on geometrical features and image features of the model, and extracting hemodynamic and mechanical characteristics (step 206) [0031]; fig 2; Hemodynamic features may be extracted, for instance, by performing computational flow dynamic analysis for various physiologic conditions (e.g., rest, exercise, hyperemia, etc.) and/or computing hemodynamic characteristics associated with lesions (e.g., max/mean/cyclic wall shear stress, traction, turbulent kinetic energy, etc.). Extracting biomechanic al features of vessel wall(s) and plaque may include defining biomechanical properties of vessel wall and plaques based on geometrical and image features (e.g., vessel wall density and elastic properties using linear or nonlinear elasticity model; plaque density and elastic properties using linear or nonlinear elasticity model; and/or ultimate strength of plaque). [0046]; biomechanical material properties of vessel wall and plaque derived from literature data and/or image characteristics (e.g., linear elastic, nonlinear elastic, viscoelastic constitutive models, density, compressible or incompressible material behavior, and/or ultimate strength of material; and biomechanical stress and strain (e.g., max or mean cyclic wall and plaque stress, max or mean cyclic wall and plaque strain, and/or alternating stress and strain) [0065]; obtaining a hemodynamic feature of the patient from a hemodynamic sensor (claim 21)),
said monitoring device comprising: a memory able to store arterial wall movement and vascular plaque movement data (Server systems 106 may include storage devices for storing images and data received from physicians 102 and/or third party providers 104. [0030]; acquire a digital representation (e.g., the memory or digital storage [e.g., hard drive, network drive] of a computational device such as a computer, laptop, DSP, server, etc.) of the following items for each time point [0053]; Acquire: one or more estimates of biophysical hemodynamic characteristic from computational fluid dynamics analysis.[0059]),
a communication interface (connected to an electronic network 100, such as the Internet, through one or more computers, servers, and/or handheld mobile devices [0030]; fig 1),
and a computation unit adapted to communicate with the monitoring device (Server systems 106 may also include processing devices for processing images and data stored in the storage devices. [0030]; fig 1) and configured to analyze measurements of the arterial wall movement and the vascular plaque movement originating from the monitoring device by artificial intelligence trained to detect whether there is a risk of at least partial rupturing or detachment of the vascular plaque (Method 420 may depict the process of a machine-learning algorithm that continually updates and revises its understanding of indications of plaque vulnerability. In other words, method 420 may be a process of training a prediction system using collected features in order to identify indications of acute myocardial infarction (MI) likelihood over time (if sufficiently large MI patient data were used for training) and/or plaque vulnerability or features of vulnerability measured from OCT, IVUS, and near-infrared spectroscopy (if a surrogate plaque vulnerability model was used for training). The trained prediction system (e.g., a machine learning system) may then be used to test a patient to predict the risk of plaque rupture or myocardial infarction by employing method 400, e.g., by obtaining an image of a patient (e.g., CTA), extracting image/hemodynamic/biomechanical features and calculating risk factors, and sending predicted risk factors to users (e.g., physicians). [0050]; fig 4).
Choi fails to disclose the monitoring device comprises at least one vibration sensor configured to measure mechanical waves propagated in said arterial wall, at least one motion sensor for the vascular plaque configured to measure movements of the vascular plaque, at least one temperature sensor configured to measure temperature of the vascular plaque; a memory able to store signals transmitted by one or more of said at least one temperature sensor, said at least one vibration sensor, and said at least one motion sensor; and a power source configured to power the communication interface and one or more of said at least one temperature sensor, said at least one vibration sensor, and said at least one motion sensor; a computation unit configured to analyze measurements of the at least one vibration sensor, of the at least one temperature sensor, and of the at least one motion sensor.
However, Kokate teaches a system for predicting an at least partial rupture or a detachment of vascular plaque that could lead to a stroke, said system comprising a monitoring device able to be placed in a vicinity of the vascular plaque (The signal from each sensor 120 may be displayed and/or recorded using a suitable instrument. Variations in these signals may be noted as catheter 100 is moved proximally and/or distally through blood vessel 20. The variations in the sensor signal may be correlated with the axial position of catheter 100. This information may be used to identify the position of any vulnerable plaque deposits in blood vessel 20. [0035]; fig 1), said monitoring device comprising at least one temperature sensor configured to measure temperature of the vascular plaque (Each sensor 120 may comprise a temperature sensor [0033]; fig 1 For example, sensors 120 which are proximate vulnerable plaque deposits 22 may read higher temperatures than sensors 120 which are not proximate vulnerable plaque deposits. [0012] It has been observed that the inflamed necrotic core of a vulnerable plaque maintains itself at a temperature which may be one or more degrees Celsius higher than the surrounding tissue. [0006]).
Kokate is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective date to have modified the system of Choi such that the monitoring device comprises at least one temperature sensor configured to measure temperature of the vascular plaque, as taught by Kokate, because temperature of vascular plaque is an indication of its vulnerability to rupture or detach and it would improve the prediction of rupture or detachment of the vascular plaque.
Choi in view of Kokate teaches a memory able to store signals transmitted by one or more of said at least one temperature sensor and a computation unit configured to analyze measurements of the at least one temperature sensor.
Choi in view of Kokate fails to teach the monitoring device comprises at least one vibration sensor configured to measure mechanical waves propagated in said arterial wall, at least one motion sensor for the vascular plaque configured to measure movements of the vascular plaque; a memory able to store signals transmitted by one or more of said at least one vibration sensor, and said at least one motion sensor; and a power source configured to power the communication interface and one or more of said at least one temperature sensor, said at least one vibration sensor, and said at least one motion sensor; a computation unit configured to analyze measurements of the at least one vibration sensor, and of the at least one motion sensor.
However, Shusterman teaches a monitoring device is a patch able to be adhered to an external surface of skin of a patient to detect rupture of a vascular plaque (FIGS. 4A-B show an example patch sensor 400, which contains two modular sensors 401. Each modular sensor 401 contains accelerometer-containing circuitry (acquisition component/module) 402 for registering mechanical vibrations (movements, accelerations) indicative of cardiovascular, respiratory, and/or other activity, as well as ECG and/or EMG electrodes 404, which are electrically coupled to the skin surface [0218]; placing the sensor in the vicinity of the abdominal aorta will facilitate the detection of an aortic aneurism and/or atherosclerotic changes (e.g., plaque, stiffening) in the abdominal aorta. [0029]) which comprises at least one vibration sensor configured to measure mechanical waves propagated in an arterial wall (Each modular sensor 401 contains accelerometer-containing circuitry (acquisition component/module) 402 for registering mechanical vibrations (movements, accelerations) indicative of cardiovascular, respiratory, and/or other activity, as well as ECG and/or EMG electrodes 404, which are electrically coupled to the skin surface using a conductive gel and/or adhesive material (e.g., a standard, disposable ECG and/or EMG electrode, such as 3M Red-Dot disposable ECG electrodes), and/or medical tape, to register electrophysiological activity (ECG and/or EMG). [0218]; fig 4A) because it aids in detection of the vascular plaque (Placing the sensor for measuring blood pressure or blood-pressure wave (which is also referred to as the pulse wave or pulse pressure) on the torso eliminates vascular-activity confounders (which are present in the peripheral arteries) and simplifies the detection, separation, and tracking of non-local (systemic) patterns of cardiac forces and/or blood-pressure dynamics, which are primarily associated with changes in cardiac output, heart rate, and systemic vascular activity. In addition, placing the sensor in the vicinity of the central blood vessels also facilitates the detection of changes in those blood vessels. For example, placing the sensor in the vicinity of the abdominal aorta will facilitate the detection of an aortic aneurism and/or atherosclerotic changes (e.g., plaque, stiffening) in the abdominal aorta. [0029]).
Shusterman is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the system of Choi in view of Kokate such that the monitoring device comprises at least one vibration sensor is configured to measure mechanical waves propagated in said arterial wall instead, as taught by Shusterman, of extracting this feature from images because it would allow continuous monitoring of the arterial wall rather than relying on images.
Choi in view of Kokate and further in view of Shusterman teaches a memory able to store signals transmitted by one or more of said at least one vibration sensor and a computation unit configured to analyze measurements of the at least one vibration sensor.
Choi in view of Kokate and further in view of Shusterman fails to teach the monitoring device comprises at least one motion sensor for the vascular plaque configured to measure movements of the vascular plaque; a memory able to store signals transmitted by one or more of said at least one motion sensor; and a power source configured to power the communication interface and one or more of said at least one temperature sensor, said at least one vibration sensor, and said at least one motion sensor; a computation unit configured to analyze measurements of the at least one motion sensor.
However, Carney teaches a system for monitoring a vascular plaque (device 10 for detecting vulnerable plaque [0026]; fig 1A) that comprises at least one motion sensor for the vascular plaque configured to measure movements of the vascular plaque (The electromagnetic radiation emitter 20 and sensor 22 are configured so that electromagnetic radiation emitted by emitter 20 will be reflected from the vascular wall 14 or vulnerable plaque lesion 30 and will be received by sensor 22. [0026]; The movement of the vessel wall and vulnerable plaque lesions that may be present both cause a deflection of the electromagnetic radiation reflected from the vessel wall, but each causes a distinctly different wave-like pattern in the amount of electromagnetic radiation received by the sensor. Because of their fluid nature, the vulnerable plaque lesions are more responsive to the pressure pulses, and produce a more pronounced wave-like pattern than the relatively stable vascular wall. The presence of vulnerable plaque lesions is determined from the extent of the deflection of the electromagnetic radiation reflected from the vascular surface (Block 79). [0042]; fig 1A & 6).
Carney is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the system of Choi in view of Kokate and further in view of Shusterman such that the monitoring device comprises at least one motion sensor for the vascular plaque configured to measure movements of the vascular plaque, as taught by Carney, instead of extracting this feature from images because it would allow continuous monitoring of the vascular plaque rather than relying on images.
Choi in view of Kokate in view of Shusterman, and further in view of Carney teaches a memory able to store signals transmitted by one or more of said at least one motion sensor and a computation unit configured to analyze measurements of the at least one motion sensor.
Choi in view of Kokate in view of Shusterman, and further in view of Carney fails to teach a power source configured to power the communication interface and one or more of said at least one temperature sensor, said at least one vibration sensor, and said at least one motion sensor.
However, Johnson teaches a monitoring device able to be placed in a vicinity of the vascular plaque (CAD detection device 400 [0102]; fig 10), a communication interface (networked or local computer system 106 is configured to store and process data received from data collection device 102 via data portal device 104 [0038]; communications circuitry 614 [0102]), and a power source configured to power the communication interface and one or more sensors (referring to FIG. 10, CAD detection device 400 comprises at least one sensor 606, a power supply 608, a controller 610, a pressure sensor 611, a memory 612, and communications circuitry 614 [0102]).
Johnson is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the system of Choi in view of Kokate in view of Shusterman and further in view of Carney such that it comprises a power source configured to power the communication interface and one or more of said at least one temperature sensor, said at least one vibration sensor, and said at least one motion sensor, as taught by Johnson, because electrical components need a power source to operate.
Regarding Claim 2, Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson teaches the invention as discussed in claim 1 above. Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson fails to teach the monitoring device further comprises at least one electrical sensor configured to measure a parameter related to the electrical impedance of the vascular plaque.
However, Kokate teaches a system for predicting an at least partial rupture or a detachment of vascular plaque that could lead to a stroke, said system comprising a monitoring device able to be placed in a vicinity of the vascular plaque (The signal from each sensor 120 may be displayed and/or recorded using a suitable instrument. Variations in these signals may be noted as catheter 100 is moved proximally and/or distally through blood vessel 20. The variations in the sensor signal may be correlated with the axial position of catheter 100. This information may be used to identify the position of any vulnerable plaque deposits in blood vessel 20. [0035]; fig 1), said monitoring device comprising at least one electrical sensor configured to measure a parameter related to the electrical impedance of the vascular plaque (device 810 does not employ thermal sensing, but rather employs impedance sensing for profiling the wall of a hollow body organ. An electrode 90 at the outside of the dog-leg bend of guidewire 816 is in electrical contact with guidewire 816 and in electrical contact with the inner wall 828 of the hollow body organ 826...A small electrical current is applied via guidewire 816 and electrode 90 to the inner wall 828 at the region of contact therebetween. The impedance of the electrical path through the body, including through the region of interest in the hollow body organ 826, can be measured and recorded.... Any change of impedance along the wall 828 indicates the presence of an anomaly in the wall, such as a plaque 92. [0047]; fig 10).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the system of Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson such that the monitoring device further comprises at least one electrical sensor configured to measure a parameter related to the electrical impedance of the vascular plaque, as taught by Kokate, because impedance is a measure that can be used to detect vascular plaques and it would provide more input information to train the artificial intelligence.
Regarding Claim 3, Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson teaches the invention as discussed in claim 1 above. Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson fails to teach the monitoring device further comprises at least one acoustic wave sensor for measuring the acoustic waves originating from the arterial wall and/or from the vascular plaque.
However, Johnson teaches a monitoring device further comprises at least one acoustic wave sensor for measuring the acoustic waves originating from the arterial wall and/or from the vascular plaque (In the embodiment depicted in FIG. 10, CAD detection device 400 comprises two pressure sensors 606a and 606b. Sensors 606a and 606b can comprise pressure, acoustic, or other sensor modalities [0103]; FIG. 7B depicts a sensor 498 on a catheter 490 configured to measure the thickness of a constriction 4946 on the interior wall of vessel 492... As such, sensor 498 will receive acoustic data reflected at the radially inner portion of constriction 494b, as well as acoustic data reflected at the interface between constriction 494b and the radially interior wall of vessel 492, as well as acoustic data reflected at the radially outer wall of vessel 492. [0086]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the system of Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson such that the monitoring device further comprises at least one acoustic wave sensor for measuring the acoustic waves originating from the arterial wall and/or from the vascular plaque, as taught by Johnson, because it would provide more information regarding the vascular plaque, improving the prediction system.
Regarding Claim 4, Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson teaches the invention as discussed in claim 1 above. Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson fails to teach the monitoring device is a patch able to be adhered to an external surface of skin of a patient.
However, Shusterman teaches a monitoring device is a patch able to be adhered to an external surface of skin of a patient to detect rupture of a vascular plaque (FIGS. 4A-B show an example patch sensor 400, which contains two modular sensors 401. Each modular sensor 401 contains accelerometer-containing circuitry (acquisition component/module) 402 for registering mechanical vibrations (movements, accelerations) indicative of cardiovascular, respiratory, and/or other activity, as well as ECG and/or EMG electrodes 404, which are electrically coupled to the skin surface [0218]; placing the sensor in the vicinity of the abdominal aorta will facilitate the detection of an aortic aneurism and/or atherosclerotic changes (e.g., plaque, stiffening) in the abdominal aorta. [0029]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the system of Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson such that the monitoring device is a patch able to be adhered to an external surface of skin of a patient, as taught by Shusterman, because it is a non-invasive method of anchoring the monitoring device to a patient.
Regarding Claim 7, Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson teaches the invention as discussed in claim 1 above. Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson teaches the at least one vibration sensor comprises an accelerometer (Each modular sensor 401 contains accelerometer-containing circuitry (acquisition component/module) 402 for registering mechanical vibrations (movements, accelerations) indicative of cardiovascular, respiratory, and/or other activity, as well as ECG and/or EMG electrodes 404, which are electrically coupled to the skin surface using a conductive gel and/or adhesive material (e.g., a standard, disposable ECG and/or EMG electrode, such as 3M Red-Dot disposable ECG electrodes), and/or medical tape, to register electrophysiological activity (ECG and/or EMG). [0218]; fig 4A).
Regarding Claim 10, Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson teaches the invention as discussed in claim 1 above. Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson teaches the power source is an induction-rechargeable battery (Power supply 608 can comprise a battery in embodiments, such as a rechargeable battery or a replaceable battery. Rechargeable power supply 608 can be inductance-style, two-pin, charge by computer, and/or charge by AC wall outlet, or some other suitable charging configuration. In embodiments, power supply 608 can be powered or recharged through inductive charging. [0110 of Johnson]; fig 10 of Johnson).
Regarding Claim 11, Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson teaches the invention as discussed in claim 1 above. Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson fails to teach the communication interface is selected from the group consisting of a short-range radio interface and/or a near-field communication interface.
However, Johnson teaches a communication interface is selected from the group consisting of a short-range radio interface and/or a near-field communication interface (data collection device 102 comprises a CAD detection device [0034]; data collection device 102 and data portal device 104 are operably coupled by a communication network and suitable hardware. For example, both data collection device 102 and data portal device 104 can comprise Universal Serial Bus (USB), Firewire, Bluetooth, serial, EEPROM, WI-FI, or any other appropriate hardware, software, and suitable interfaces. [0037]).
While Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson teaches a communication interface, they fail to teach specifics of the communication interface. As such, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the system of Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson such that the communication interface is selected from the group consisting of a short-range radio interface and/or a near-field communication interface, as taught by Johnson, because short-range radio interfaces and/or near-field communication interfaces are types of communication interfaces.
Regarding Claim 12, Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson teaches the invention as discussed in claim 1 above. Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson fails to teach at least one mobile communication appliance adapted to remotely communicate with the monitoring device via said communication interface.
However, Johnson teaches at least one mobile communication appliance adapted to remotely communicate with a monitoring device via a communication interface (User 116 can receive results from data collection device 102 [0042]; In embodiments, a mobile application on, for example, a smartphone, can be configured to receive the streamed data. In embodiments, data collection device 102 can comprise cellular data hardware (4G, LTE, etc.) in order to wirelessly transmit the collected data. [0055]; data collection device 102 comprises a CAD detection device [0034]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the system of Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson such that at least one mobile communication appliance adapted to remotely communicate with the monitoring device via said communication interface, as taught by Johnson, because it would allow a user to stay updated with his/her health.
Regarding Claim 13, Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson teaches the invention as discussed above in claim 3. Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson fails to teach a measurement frequency of one or more of said at least one temperature sensor, said at least one vibration sensor, and said at least one motion sensor is set so as to transmit and/or receive a signal originating from an internal jugular vein.
However, it is noted that Applicant has failed to provide details of criticality or unexpected results in the Specification with regard to the claimed measurement frequency. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine an optimum measurement frequency of one or more of said at least one temperature sensor, said at least one vibration sensor, and said at least one motion sensor.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi (US Patent Pub. No. 20170340393 – cited by Applicant) in view of Kokate (US Patent Pub. No. 20030125637 – cited by Applicant), in view of Shusterman (US Patent Pub. No. 20180020931), in view of Carney (US Patent Pub. No. 20040243022), and further in view of Johnson (US Patent Pub. No 20180235470) as applied to claim 1 above, and further in view of Mitchell et al. (US Patent Pub. No. 20200155003) hereinafter Mitchell.
Regarding Claim 5, Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson teaches the invention as discussed above in claim 1. Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson fails to teach the monitoring device is a subcutaneous implant able to be inserted under skin of a patient.
However, Mitchell teaches a subcutaneous implant device with motion and temperature sensors (The device 100 is configured to be implanted within a human patient H, such as at a subcutaneous location along an upper region of the patient's chest. As shown in FIG. 1, the device 100 may include a sensing element 110 configured to obtain physiological measurements that are used by the system 10 to determine one or more physiological parameters indicative of the patient's health. [0285]; the sensing element(s) 110 and/or controller 112 may identify, monitor, and communicate patient information by electromagnetic, acoustic, motion, optical, thermal, or biochemical sensing elements or means. The sensing element(s) 110 may include, for example, one or more temperature sensing elements (e.g., one or more thermocouples, one or more digital temperature sensors, one or more thermistors or other type of resistance temperature detector, etc.), one or more impedance sensing elements (e.g., one or more electrodes), one or more pressure sensing elements, one or more optical sensing elements, one or more flow sensing elements (e.g., a Doppler velocity sensing element, an ultrasonic flow meter, etc.), one or more ultrasonic sensing elements, one or more pulse oximeters, one or more chemical sensing elements, one or more movement sensing elements (e.g., one or more accelerometers), one or more pH sensing elements, an electrocardiogram (“ECG” or “EKG”) unit, one or more electrochemical sensing elements, one or more hemodynamic sensing elements, and/or other suitable sensing devices. [0301]).
Mitchell is considered analogous art to the present invention because it is reasonably pertinent to a problem faced by the inventors.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the system of Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson such that the monitoring device is a subcutaneous implant able to be inserted under skin of a patient, as taught by Mitchell, because it allows for anchoring the monitoring device close to an area of interest.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi (US Patent Pub. No. 20170340393 – cited by Applicant) in view of Kokate (US Patent Pub. No. 20030125637 – cited by Applicant), in view of Shusterman (US Patent Pub. No. 20180020931), in view of Carney (US Patent Pub. No. 20040243022), and further in view of Johnson (US Patent Pub. No 20180235470) as applied to claim 1 above, and further in view of Castella et al. (US Patent Pub. No. 20080095714) hereinafter Castella.
Regarding Claim 6, Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson teaches the invention as discussed above in claim 1. Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson fails to teach the at least one temperature sensor is configured for detecting thermal waves emitted by the vascular plaque.
However, Castella teaches a temperature sensor configured to detect thermal waves emitted by a vascular plaque (As shown in FIG. 1, the thermal imaging apparatus 10 generally comprises a thermal sensor 30, a laser-heating element 40 coupled to the thermal sensor 30; a reflecting element 42 coupled to the laser heating element 40; and a catheter 20 coupled to the thermal imaging apparatus 10... The thermal imaging apparatus 10 is coupled with nanoparticles 60 by the laser heating element 40 in order measure the increase of the temperature of plaques 70 due to inflammation in a blood vessel 72. [0029]). Castella also teaches that the temperature of vascular plaques is increased compared to normal tissue (Atherosclerotic plaques have an increased endogenous temperature due to inflammatory processes and metabolic congestion, i.e. increase density of macrophages 74. Macrophages selectively uptake nanoparticles 60, such as when they are administered into the bloodstream, and therefore the nanoparticles 60 will selectively accumulate at the site of macrophage concentration, such as in atherosclerotic plaques. Therefore, the temperature differences in the plaques 70 can be artificially increased by the nanoparticles selectively heated by a laser heating element 40, and thus an enhanced thermal image of the macrophages 74 can be produced. [0029]; The thermal imaging apparatus 10 further allows for therapies based on the identification and location of macrophage-laden plaque, such as using the information to place stents (bare metal, drug eluting, covered). Additionally, treatments based on selective nanoparticle uptake could be administered [0030]).
Castella is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the system of Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson such that the at least one temperature sensor is configured for detecting thermal waves emitted by the vascular plaque, as taught by Castella, because temperature is an indicator of the presence of vascular plaques.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi (US Patent Pub. No. 20170340393 – cited by Applicant) in view of Kokate (US Patent Pub. No. 20030125637 – cited by Applicant), in view of Shusterman (US Patent Pub. No. 20180020931), in view of Carney (US Patent Pub. No. 20040243022), and further in view of Johnson (US Patent Pub. No 20180235470) as applied to claim 7 above, and further in view of Washburn, II et al. (US Patent Pub. No. 20170265879) hereinafter Washburn, II.
Regarding Claim 8, Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson teaches the invention as discussed above in claim 7. Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson teaches the vibration sensor comprises an accelerometer and a gyroscope. Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson fails to teach the vibration sensor comprises a 3-axis accelerometer and a 3-axis gyroscope.
However, Washburn, II teaches using a 3-axis accelerometer and a 3-axis gyroscope to provide a full six degree-of-freedom description of a sensor’s motion and position (the rotational orientation image correction system may comprise a 3-axis accelerometer [0147]; in addition to the accelerometer, the visualization device may carry a gyroscope such as a three-axis gyroscope. The output of the gyroscope may be the rate of change of roll angle, pitch angle and yaw angle and rotational rate measurements provided by the gyroscope can be combined with measurements made by the accelerometer to provide a full six degree-of-freedom description of the sensor 1132's motion and position [0148]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the system of Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson such that the vibration sensor comprises a 3-axis accelerometer and a 3-axis gyroscope, as taught by Washburn, II, because it would provide a full six degree-of-freedom description of a sensor’s motion and position.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi (US Patent Pub. No. 20170340393 – cited by Applicant) in view of Kokate (US Patent Pub. No. 20030125637 – cited by Applicant), in view of Shusterman (US Patent Pub. No. 20180020931), in view of Carney (US Patent Pub. No. 20040243022), and further in view of Johnson (US Patent Pub. No 20180235470) as applied to claim 1 above, and further in view of Tupin, JR. et al. et al. (US Patent Pub. No. 20130245436) hereinafter Tupin, JR.
Regarding Claim 9, Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson teaches the invention as discussed in claim 1 above. Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson fails to teach the at least one motion sensor is an ultrasound probe.
However, Tupin, JR. teaches an ultrasound probe detects motion (The transducer uses Doppler ultrasound to detect fetal heart motion).
Tupin, JR. is considered analogous art to the present invention because it is reasonably pertinent to a problem faced by the inventors.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the system of Choi in view of Kokate in view of Shusterman in view of Carney and further in view of Johnson such that the at least one motion sensor is an ultrasound probe, as taught by Tupin, JR. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Conclusion
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/JANKI M BAVA/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791