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 .
Information Disclosure Statement
The information disclosure statement filed fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. Only the non-patent literature citation No. 4 was submitted.; citation Nos.1, 2, and 3 were not provided.
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, 6, 13 and associated dependent claims 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 pre-AIA the applicant regards as the invention. The term “direct” in claims 2, 6 and 13 is a relative term which renders the claim indefinite. The term “direct” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
As written, the limitation could encompass contact at the skin surface overlying a blood vessel or contact requiring penetration of the skin to physically contact the vessel itself, thereby affecting the scope of the claim.
Claim Rejections - 35 USC § 102
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. (FP 7.08.aia)
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. (FP 7.12.aia)
Claims 1, 4, 7 ,8, 10, and 11 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by “Honore” (U.S Publication No 20180070841 A1).
Regarding claim 1, Honore teaches a device for measuring blood-related parameters, said device comprising (FIG.3D, paragraph 0113, 0116):
a sensor module (FIG.3D, 388) adapted to measure vibrational or acoustic signals from a patient's blood flow;
a data-acquisition unit, communicatively coupled to said sensor module, and adapted to digitize said vibrational or acoustic signals (FIG.3D,304);
a memory unit, communicatively coupled to said data-acquisition unit, and adapted to buffer and save said digitized vibrational or acoustic signals (FIG.3D, 390); and
a data-processing unit, communicatively coupled to said memory unit, and adapted to convert said digitized vibrational or acoustic signals into one or more measured parameters (FIG.3D,304).
With respect to claim 4 Honore discloses that the combination of a three-axis accelerometer with a photoplethysmography(PPG) provides an accurate assessment of blood volume and acceleration, and that said assessment values are processed by the disclosed data-processing system to calculate a blood pressure (0116).
Regarding claims 7 and 8 Honore discloses the use of an acoustic sensor to identify a highest break frequency, which is correlated with a narrower vessel, (paragraph 0137). Honore further teaches a data-processing system including a process and a storage medium configured to utilize the break frequency to estimate an internal diameter of a carotid artery for the patient. Based on the determined break frequency, the system enables a determination as to whether vessel flow is normal or narrowed or obstructed (0171).
Regarding claim 10, Honore is cited as teaching further a sensor module, photoplethysmogram sensor (Fig.3D, 388b, paragraph 0114)).
Regarding claim 11 Honore is cited as teaching the data-processing system adapted to obtain acceleration values from digitized vibrational or acoustic signals, explicitly disclosing components for data-processing, wherein comprising of an accelerometer measuring acceleration, an analog-to-digital converter to digitize vibrational or wave form signals into electrical signals with signal processing capabilities of a processor to perform calculation (paragraph 0048, paragraph 0116).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Honore in view of “Hong” (CN213883186U).
Regarding claim 2, Honore fails to teach a limitation of direct contact with the patient’s blood vessels, broadly interpreting the limitation as “contact at the skin surface overlying a blood vessel”. However, Hong teaches a sensor configured to contact the skin of the radial artery and to detect pulse wave signals for cuff-less blood pressure monitoring. Honore and Hong are both directed to wearable monitoring devices and are therefore considered as analogous art. Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have modified Honore in view of the teaching of Hong to incorporate a sensor configured to contact the skin over the radial artery for blood pressure monitoring (Hong, claim 2). Such a modification would have predictably enhanced the measurement of blood-related parameters, including blood pressure, with improved accuracy.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Honore in view of “Haescher”, “A Study on Measuring Heart and Respiration Rate via Wrist-Worm Accelerometer-based Seismocardiography (SCG) in Comparison to Commonly Applied Technologies”.
Regarding claim 3, Honore fails to teach a limitation of “said module consists of an accelerometer”. However, Haescher teaches only the sole use of an accelerometer for heart rate measurement. Honore and Haeschler are both directed to wearable physiological monitoring devices and therefore, are considered analogous art. Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have modified Honore in view of the teaching of Haeschler to use an accelerometer for heart-related parameters. Such a modification would have predictably allowed the measurement of blood-related parameters with less components.
Claim 5 are rejected under 35 U.S.C. 103 as being unpatentable over Honore in view of “Archdeacon” (US 10786161 B1).
Regarding claim 5, Honore fails to teach a limitation of “said device is integrated on a smart watch” although Honore teaches a wearable device with multimodal diagnostics. However, Archdeacon discloses wearable devices including a watch, a wristband, and fitness tracker. Explicitly, Fig 11A shows a smartwatch connected to sensors (col1, line 20, col 24, line 15). Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have modified Honore in view of the teaching of Archdeacon to incorporate a smartwatch into the wrist-worn blood pressure monitoring device for blood pressure monitoring purpose. Such a modification would have predictably provided physiological information including blood pressure or heart rate to alert the patient remotely.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Honore in view of Archdeacon as applied to claim 5 above, and further in view of Hong.
Regarding claim 6, Honore and Archdeacon fail to teach a limitation of direct contact with the patient’s blood vessels, broadly interpreting the limitation as “contact at the skin surface overlying a blood vessel”. However, Hong teaches a sensor configured to contact the skin of the radial artery and to detect pulse wave signals for cuff-less blood pressure monitoring (claim 2). Honore, Archdeacon and Hong are all directed to wearable monitoring devices and are therefore considered as analogous art. Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have modified Honore and Archdeacon in view of the teaching of Hong to incorporate a sensor configured to contact the skin over the radial artery for blood pressure monitoring. Such a modification would have predictably enhanced the measurement of blood-related parameters, including blood pressure, with improved accuracy.
Claim 9 ais rejected under 35 U.S.C. 103 as being unpatentable over Honore in view of “Wang”, “An Ambulatory Blood Pressure Monitor Mobile Health System for Early Warning for Stroke Risk: Longitudinal Observational Study”.
Regarding Claim 9, Honroe teaches providing alerts or notifications indicating urgency (0030); however, Honroe does not explicitly disclose warnings of stroke or arrhythmia in association with blood pressure monitoring.
Wang developed an early warning system for stroke risk, an Ambulatory Blood Pressure Monitor Mobile Health System, that continuously monitors blood pressure and detect early stroke-risk indicators in real-time (abstract). Wang teaches a warning system (col 24, line 15, col 1, line 20, Fig. 11A) for detecting elevated blood pressure and alerting to a patient of stroke or arrhythmia. Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have modified Honore with the teaching of Wang to incorporate an alert system for detecting potential stroke or arrythmia or elevated blood pressure.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Honore in view of “Marinkovic”, “Reconstructing the Blood Pressure Waveform using a Wearable Photoplethysmograph Sensor and Hydrostatic Pressure Variations Measured by Accelerometers”.
Regarding claim 12, Honore does not expressly teach converting acceleration values into a pressure wave or estimating a pressure waveform from acceleration data. Marinkovic discloses a process configured to reconstruct an arterial pressure waveform using accelerometer-derived hydrostatic pressure variations and signal modeling techniques (pp.37-48). In particular, Marinkovic teaches reconstructing a continuous arterial blood pressure waveform through modeling and inversion of accelerometer-related signals. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Honores in view of Hong and Marinkovic to incorporate processing of accelerometer data to derive or represent a pressure waveform for physiological monitoring. The motivation to combine arises from the relationship between arterial vibration signals and underlying pressure waveforms that may indicate the presence of disease, and from the known use of modeling techniques to reconstruct pressure waveforms from accelerometer-related measurements. Such a modification would have been a predictable use of known signal processing techniques to improve cardiovascular parameter assessment (Marinkovic: 1.2 Motivation).
Claims 13-18 is rejected under 35 U.S.C. 103 as being unpatentable over Honore in view of Hong and Marinovic.
Regarding claim 13, Honore teaches a wearable patch device configured to calculate a patients’ blood pressure using an accelerometer in combination of a PPG sensor. The device is worn over an area of tissue having an arteriovenous access located directly beneath the patch. Honore further discloses data-processing component, including an accelerometer configured to measure acceleration, an analog-to-digital converter configured to digitize vibrational or wave form signals into electrical signals, and a processor configured to perform signal processing and calculations (paragraph 0048, paragraph 0116).
However, Honore does not expressly teach the limitation of contact with the patient’s blood vessels and converting acceleration values into a pressure wave or estimating a pressure waveform from acceleration data.
Hong discloses an acceleration sensor configured to detect pulse wave signals at the artery. Pulse wave signals correspond to pressure-related arterial waveforms generated by blood flow. Hong further teaches a sensor configured to contact the skin overlying the radial artery and to detect pulse wave signals for cuff-less blood pressure monitoring (claim 2).
As discussed above with respect to claim 12, although Hong does not explicitly disclose a transformation process for converting acceleration values into a pressure wave, Marinkovic discloses a process configured to reconstruct an arterial pressure waveform using accelerometer-derived hydrostatic pressure variations and signal modeling techniques. In particular, Marinkovic teaches reconstructing a continuous arterial blood pressure waveform through modeling and inversion of accelerometer-related signals (pp.37-48).
Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Honore in view of Hong and further in view of Marinkovic to incorporate (1) positioning of an accelerometer sensor overlying an artery to detect arterial pulse wave signals and (2) acquisition of acceleration signals, and (3) processing of such acceleration data to represent a pressure waveform. Such a modification would have been a predictable use of known signal processing techniques and signal modeling to improve cardiovascular parameter assessment from a patient’s blood vessels (Marinkovic: 1.2 Motivation).
Regarding claim 14, Honore teaches an accelerometer in combination of a PPG sensor configured to measure vibrational or acoustic signals for blood related parameters [0116].
Regarding Claim 15, Honore further teaches a PPG sensor (Fig 3D, 388b) (paragraph 0114).
Regarding claim 16, Honore teaches the use of a high break frequency correlated with vessel size. Specifically, a higher break frequency is indicative of a narrower vessel and may be used to determine the possible formation of thrombosis (paragraph 0005).
Regarding Claim 17 Honore teaches that the combination of a three-axis accelerometer with a photoplethysmography (PPG) provides an accurate assessment of blood volume and acceleration, and that said assessment values are processed by the disclosed data-processing system to calculate a blood pressure (paragraph 0116).
Regarding Claim 18 Honore further teaches a data-processing system including a process and a storage medium configured to utilize the break frequency to estimate an internal diameter of a carotid artery for the patient. Based on the determined break frequency, the system enables a determination as to whether vessel flow is normal or narrowed or obstructed (paragraph 0171
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Honore in view of Hong and Marinovic as applied to claim 14 above, and further in view of “Wang”, “An Ambulatory Blood Pressure Monitor Mobile Health System for Early Warning for Stroke Risk: Longitudinal Observational Study”.
Regarding claim 19 and 20, Honore discloses estimating vessel narrowing at an increased level of stenosis (0117) and estimating the internal diameter of a carotid artery (0171), both of which are relevant to stroke assessment. Honroe teaches providing alerts or notifications indicating urgency (0030); however, Honroe does not explicitly disclose warnings of stroke or arrhythmia in association with blood pressure monitoring.
Wang developed an early warning system for stroke risk, an Ambulatory Blood Pressure Monitor Mobile Health System, that continuously monitors blood pressure and detect early stroke-risk indicators in real-time (abstract). Wang teaches a warning system (col 24, line 15, col 1, line 20, Fig. 11A) for detecting elevated blood pressure and alerting to a patient of stroke or arrhythmia. Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have modified Honore with the teaching of Wang to incorporate an alert system for detecting potential stroke or arrythmia or elevated blood pressure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MORGAN S SHIM whose telephone number is (571)272-9032. The examiner can normally be reached Mon-Fri 7:30AM-4:30PM.
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/MORGAN SANGJO SHIM/Examiner, Art Unit 3791
/TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791