DETAILED ACTION
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.
Claims 1, 5, 8-9, 14-15 and 19-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Srinivasan et al., US-PGPUB 2021/0153755 (hereinafter Srinivasan)
Regarding Claims 1 and 5. Srinivasan discloses calibrating a wearable device secured to a user with an elastic strap (Abstract; Paragraph [0005]; Figs. 5-6), by:
placing an optical sensor of the wearable device in a position over a radial artery
of a user while secured with the strap (Paragraph [0060], optical sensor);
positioning a force sensor to measure a contact force between the wearable
device and the user (Paragraph [0009]-[0011], force sensor); and
obtaining calibration data for a blood pressure measurement of the user with the
wearable device by acquiring optical data from the optical sensor and force
measurements from the force sensor while applying a range of forces toward
the user with the wearable device (Paragraphs [0004]-[0005], [0011], [0043]-[0049], [0054]); and
acquiring calibrated blood pressure measurements by: measuring a tension of the elastic strap in the position; while in the position, acquiring pulse data from the optical sensor over an interval, and calculating an instantaneous blood pressure for the user based on the pulse data, the tension of the elastic strap, and the calibration data (Claims 1-7, infer diastolic and systolic blood pressure).
Regarding Claim 8. Srinivasan discloses applying the range of forces includes manually applying a time-varying force to the wearable device while measuring the contact force between the wearable device and the user (Paragraphs [0003]-[0005], [0010], [0034], forces)
Regarding Claim 9. Srinivasan discloses the calibration data includes K values calculated for the optical data while measuring the contact force between the wearable device and the user (Paragraphs [0043]-[0044], [0049])
Regarding Claim 14. Srinivasan discloses the force sensor is removably and replaceably coupled to the wearable device (Claim 12, removable strap force sensor)
Regarding Claim 15. Srinivasan discloses the force sensor is a disposable pressure sensor removably affixed to an exposed surface of the wearable device and accessible to a user when the wearable device is placed for use on the user (Claim 12, removable strap force sensor)
Regarding Claim 19. Srinivasan the wearable device includes a wearable continuous physiological monitor (Paragraphs [0003]-[0004])
Regarding Claim 20. Srinivasan discloses the range of forces includes a range of forces creating pressure on the user from less than 40 mmHg to greater than 150 mmHg (Fig. 3B)
Regarding Claim 21. Srinivasan discloses the range of forces includes a range of forces creating pressure on the user from less than 70 mmHg to greater than 140 mmHg (Fig. 3B)
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.
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.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Srinivasan et al., US-PGPUB 2021/0153755 in view of Gelissen et al., US-PGPUB 2019/0282107 (hereinafter Gelissen)
Regarding Claim 2. Srinivasan discloses a wearable device including an optical sensor, a force sensor, and a strap for securing the wearable device to a user, and one or more processors (Paragraphs [0004]-[0011], [0060], [0068]; Figs. 5, 6), configured to:
to obtain calibration data for calculating a calibrated blood pressure measurement with the wearable device (Paragraphs [0043]-[0049]),
measure a tension of the strap, based on a third set of optical data from the optical sensor, the tension of the strap, and the calibration data, calculating a current blood pressure for the user over an interval and calculate a diastolic blood pressure and a systolic blood pressure for the user based on changes in the current blood pressure over the interval (Paragraph [0061]; Claims 1-7, diastolic and systolic blood pressure determined)
Srinivasan does not disclose guiding the user of the wearable device through a positioning process, based on a first set of optical data from the optical sensor, to locate the optical sensor over a radial artery of the user, guide the user of the wearable device through a calibration process, based on a second act of optical data from the optical sensor and concurrent force data from the force sensor,
Gelissen discloses a wearable device including an optical sensor, a force sensor, and a strap for securing the wearable device to a user (Abstract; Paragraphs [0012]-[0015]; Fig. 8), and one or more processors (Fig. 1, 140, Paragraph [0052], processor), configured to: guide the user of the wearable device through a positioning process, based on a first set of optical data from the optical sensor, to locate the optical sensor over a radial artery of the user, guide the user of the wearable device through a calibration process, based on a second act of optical data from the optical sensor and concurrent force data from the force sensor, to obtain calibration data for calculating a calibrated blood pressure measurement with the wearable device (Paragraph [0050]-[0051], strap; Paragraph [0060], guide through the measurement process, obviously involves the steps claimed; Paragraphs [0019], [0056], [0063], calibration)
measure a tension of the strap (Paragraphs [0050]-[0052]);
based on a third set of optical data from the optical sensor, the tension of the strap,
and the calibration data, calculating a current blood pressure for the user over an
interval (Paragraphs [0018]-[0019])
At the time of the invention filed, it would have been obvious to a person of ordinary skill in the art to use the teaching of Gelissen in Srinivasan and guide the user of the wearable device through a positioning process, based on a first set of optical data from the optical sensor, to locate the optical sensor over a radial artery of the user, guide the user of the wearable device through a calibration process, based on a second act of optical data from the optical sensor and concurrent force data from the force sensor, so as to properly determine the blood pressure.
Regarding Claim 3. Srinivasan discloses a display configured to present the diastolic blood pressure and the systolic blood pressure to the user (Paragraph [0038], display, and obvious to display said pressures, since they are parameters associated with monitoring of blood pressure)
Regarding Claim 4. Srinivasan discloses the force sensor includes a removable and replaceable force sensor (Claim 10 and Claim 12, strap force sensor, where strap is removably attached).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Srinivasan et al., US-PGPUB 2021/0153755 in view of Donehoo et al., US-PGPUB 2013/0158969 (hereinafter Donehoo)
Regarding Claim 6. Srinivasan discloses the calibration data includes an oscillometric derived from the optical data (Paragraph [0062], [0048])
Srinivasan does not explicitly disclose oscillometric envelope derived from the optical data.
Donehoo discloses oscillometric envelope in the blood pressure measurements (Abstract; Paragraphs [0001]-[0006], [0023]; Figs. 1-5)
At the time of the invention filed, it would have been obvious to a person of ordinary skill in the art to use the teaching of Donehoo in Srinivasan and use the calibration data includes an oscillometric envelope derived from the optical data, so as to accurately calibrate and determine the blood pressure.
Regarding Claim 7. Srinivasan discloses the calibration data includes an oscillometric derived from the optical data while applying a range of forces toward the user with the wearable device (Paragraph [0062], [0048])
Srinivasan does not disclose the calibration data includes a transfer function for an oscillometric envelope derived from the optical data acquired.
Donehoo discloses the calibration data includes a transfer function for an oscillometric envelope derived from the optical data acquired (Abstract; Paragraphs [0001]-[0006], [0023], [0029]-[0037]; Figs. 1-5)
At the time of the invention filed, it would have been obvious to a person of ordinary skill in the art to use the teaching of Donehoo in Srinivasan and have the calibration data includes a transfer function for an oscillometric derived from the optical data while applying a range of forces toward the user with the wearable device, so as to accurately calibrate and determine the blood pressure.
7. Claims 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Srinivasan et al., US-PGPUB 2021/0153755 in view of Miller et al., US Pat No. 10,307,101 (hereinafter Miller).
Regarding Claims 10 and 13. Srinivasan discloses light source (Paragraph [0051]) and placing the optical sensor includes positioning the wearable device in the position over the radial artery (Paragraphs [0060], [0068], optical sensors; Fig. 2)
Srinivasan does not disclose a first optical path from an optical source to a first sensor of the optical sensor that passes through the radial artery, and a second optical path from the optical source to a second sensor of the optical sensor that does not pass through the radial artery.
Miller discloses a first optical path from an optical source to a first sensor of the optical sensor that passes through the radial artery, and a second optical path from the optical source to a second sensor of the optical sensor that does not pass through the radial artery (Claim 7), where the level of electrolytes may operate as an indicator of hydration condition and excess sodium can cause increase in the blood pressure of a user (Col. 3, lines 1-58) (regarding Claim 13: the optical sensor includes at least an illumination source, a first photodetector positioned to detect light from the illumination source directed toward a radial artery of the user when the wearable device is placed for use, and a second photodetector positioned to detect light from the illumination source directed away from the radial artery of the user when the wearable device is placed for use (Claim 7)
At the time of the invention filed, it would have been obvious to a person of ordinary skill in the art to use the teaching of Miller in Srinivasan and have a first optical path from an optical source to a first sensor of the optical sensor that passes through the radial artery, and a second optical path from the optical source to a second sensor of the optical sensor that does not pass through the radial artery (claim 13: the optical sensor includes at least an illumination source, a first photodetector positioned to detect light from the illumination source directed toward a radial artery of the user when the wearable device is placed for use, and a second photodetector positioned to detect light from the illumination source directed away from the radial artery of the user when the wearable device is placed for use), so as to accurately determine the blood pressure.
8. Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Srinivasan et al., US-PGPUB 2021/0153755 in views of Presura, US-PGPUB 2020/0093434 (hereinafter Presura) (and alternately in view of Yamada et al., US-PGPUB 2018/0014758 (hereinafter Yamada)), Klaassen, US-PGPUB 2017/0340209 (hereinafter Klaassen) and Gelissen, US-PGPUB 2019/0282107
Regarding Claim 11. Srinivasan discloses the wearable device for positioning over the radial artery (Figs. 5-6) by providing illumination with an optical source (Paragraph [0051]), receiving a first optical signal at a first optical sensor, receiving a second optical signal at a second optical sensor (Paragraph [0068], optical sensors)
Srinivasan does not explicitly disclose the wearable device is guided for positioning over the radial artery, and does not disclose; and guiding a user to move the optical sensor toward the position over the radial artery based on a difference between the first optical signal and the second optical signal.
Presura discloses determining the blood pressure from the first and second optical sensors over the artery (Paragraphs [0030]-[0031]; Abstract; Figs. 1-7; Paragraphs [0001]-[0006]) (and alternately Yamada discloses determining the blood pressure from the first and second optical sensors over the artery (Paragraph [0022], Paragraphs [0024]-[0027], [0035]-[0039], Figs. 1-9)
Klaassen discloses that signals from the sensor assembly further from the radial artery provide weaker signals that are not as meaningful for determining a blood pressure of a user (Paragraphs [0205]-[0206]; [0010], [0131], optical sensor)
Gelissen discloses a wearable device including an optical sensor, a force sensor, and a strap for securing the wearable device to a user (Abstract; Paragraphs [0012]-[0015]; Fig. 8), and one or more processors (Fig. 1, 140, Paragraph [0052], processor), configured to: guide the user of the wearable device through a measurement process (Paragraph [0060])
At the time of the invention filed, it would have been obvious to a person of ordinary skill in the art to use the teachings of Gelissen, Klaassen and Presura (and Yamada) in Srnivasan and guide the wearable device for positioning over the radial artery, and guide a user to move the optical sensor toward the position over the radial artery based on a difference between the first optical signal and the second optical signal, so as to reliably obtain the blood pressure of a user.
Regarding Claim 12. Gellisen discloses obtaining calibration data includes guiding the user through an application of varying pressures to the radial artery while capturing the optical data as a difference signal between the first optical signal and the second optical signal (Paragraph [0060])
9. Claims 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Srinivasan et al., US-PGPUB 2021/0153755 in view of Gelissen, US-PGPUB 2019/0282107
Regarding Claim 16. Srinivasan does not disclose the optical data includes an optical signal from a photoplethysmography heart rate monitor.
Gelissen discloses optical data includes an optical signal from a photoplethysmography heart rate monitor (Paragraphs [0002]-[0004], [0013], [0036])
At the time of the invention filed, it would have been obvious to a person of ordinary skill in the art to use the teaching of Gelissen in Srinivasan and have the optical data includes an optical signal from a photoplethysmography heart rate monitor, and measure the blood pressure, as these monitors are well known.
Regarding Claim 18. Srinivasan does not disclose guiding the user to position the wearable device about a wrist of the user by presenting instructions to the user in a user interface.
Gelissen discloses guiding the user during the measurement process (Paragraph [0060])
At the time of the invention filed, it would have been obvious to a person of ordinary skill in the art to use the teaching of Gelissen in Srinivasan and guide the user to position the wearable device about a wrist of the user by presenting instructions to the user in a user interface, so as to properly measure the blood pressure.
10. Claims 17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Srinivasan et al., US-PGPUB 2021/0153755 in view of Qasem, US-PGPUB 2018/0296104 (hereinafter) and alternately in view of Qasem, US-PGPUB 2021/0212575 (hereinafter Qasem-2)
Regarding Claim 17. Srinivasan discloses the calibration data includes a waveform for the optical data captured over a range of pressures including at least a first pressure corresponding to a diastolic pressure and a second pressure corresponding to a systolic pressure (Figs. 3; Paragraphs [0033], [0061])
Srinivasan does not disclose the calibration data includes a waveform for the optical data captured over a range of pressures including at least a first pressure corresponding to a diastolic pressure for a population of users and a second pressure corresponding to a systolic pressure for the population of users (Regarding Claim 22: wherein the range of forces includes a range selected to create pressures on the user from at least a diastolic pressure for a population to a systolic pressure for the population)
Qasem discloses calibration data includes a waveform captured over a range of pressures including at least a first pressure corresponding to a diastolic pressure for a population of users and a second pressure corresponding to a systolic pressure for the population of users, (Claim 22: wherein the range of forces includes a range selected to create pressures on the user from at least a diastolic pressure for a population to a systolic pressure for the population) (Claims 5-6, Paragraph [0037], [0043]-[0069])
At the time of the invention filed, it would have been obvious to a person of ordinary skill in the art to use the teaching of Qasem in Srinivasan and have calibration data includes a waveform captured over a range of pressures including at least a first pressure corresponding to a diastolic pressure for a population of users and a second pressure corresponding to a systolic pressure for the population of users, (Claim 22: wherein the range of forces includes a range selected to create pressures on the user from at least a diastolic pressure for a population to a systolic pressure for the population), so as to accurately determine the blood pressure.
---------- alternate rejection--------
Qasem-2 discloses calibration data includes a waveform captured over a range of pressures including at least a first pressure corresponding to a diastolic pressure for a population of users and a second pressure corresponding to a systolic pressure for the population of users, (Claim 22: wherein the range of forces includes a range selected to create pressures on the user from at least a diastolic pressure for a population to a systolic pressure for the population) (Claim 23, Paragraph [0047])
At the time of the invention filed, it would have been obvious to a person of ordinary skill in the art to use the teaching of Qasem-2 in Srinivasan and have calibration data includes a waveform captured over a range of pressures including at least a first pressure corresponding to a diastolic pressure for a population of users and a second pressure corresponding to a systolic pressure for the population of users, (Claim 22: wherein the range of forces includes a range selected to create pressures on the user from at least a diastolic pressure for a population to a systolic pressure for the population), so as to accurately determine the blood pressure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wong et al., US-PGPUB 2019/0282105
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/HYUN D PARK/Primary Examiner, Art Unit 2857
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