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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21-40 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 21, 33 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The term “a sensor array in contact with or proximate to tissue” is directed to or encompassing a human organism.
Claims 22-32, 34-40 are rejected for the same reasons because they depend on claims 21 and 33.
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.
Claim(s) 21-24, 26, 28-40 are rejected under 35 U.S.C. 103 as being unpatentable over Brockway et al (Pub. No.: US 2013/0289424) in view of Lisogurski et al (Pub, No.: US 2015/0157269).
Regarding claims 21, 33, Brockway et al disclose a system for determining correct photoplethysmography device positioning on a user, the system comprising:
a photoplethysmography device having a sensor array (one or more physiological signals via sensors 201) in contact with or proximate to tissue of the user [see 0072, 0076];
configured to receive energy reflected by or transmitted through the tissue of the user [see 0072];
one or more processors in communication with the photoplethysmography device
and configured to implement a signal validity classification system to use a validity threshold [see 0061-0061, 0115] to determine:
(i) validity of one or more signals received by the sensor array [see 0061-0063];
wherein the validity threshold is based on a weight, a height, or a particular health condition of (arrhythmia event) the user [see 0061-0064, 0079-0080, 0115] by disclosing a confidence value is computed as a function of the SNR, and the detected cardiac event is classified as valid in response to said confidence signal exceeding a predetermined first threshold. Such confidence values may, for example, make up part of a confidence signal that includes one or more such values. In addition, the confidence value may be computed based upon the SNR, morphology of the signal and a pattern of feature points in the signal [see 0061].
a communication circuit to confirm that the electrodes (photoplethysmography device) have been placed on the subject properly and the device is acquiring data appropriately [see 0196];
control operation of the photoplethysmography device depending on the determination as to whether or not the photoplethysmography device (sensing electrodes) is correctly positioned on the user [see 0196-0197].
Brockway et al don’t disclose whether or not the photoplethysmography device is correctly positioned on the user to measure medical signs of the user based on the validity threshold,
Nonetheless, Lisogurski et al disclose whether or not the photoplethysmography device is correctly positioned on the user to measure medical signs of the user based on the validity threshold [see 0178-0179; fig 10] by disclosing a calibration routine can be performed which establishes measurement thresholds (validity threshold) to indicate when probe 1610 is placed on tissue 1640 or off of tissue 1640 and measurement equipment can detect when probe 1610 has fallen off or been removed from tissue 1640 and alert monitoring personnel accordingly [see 0178-0179].
Lisogurski et al disclose measurement parameters can be modified based on the body location and placement, such as loading correct calculation coefficients based on the placement or body location [see 0123].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Brockway et al and Lisogurski et al by determining whether or not the photoplethysmography device is correctly positioned on the user to measure medical signs of the user based on the validity threshold; to enhance physiological measurements [see 0164, Lisogurski et al]
Regarding claims 22, 34, Brockway et al disclose wherein the signal validity classification system is configured to determine the validity of the one or more signals received by the sensor array by
calculating a validity score (validity metric/value or confidence values) for the received one or more signals [see 0097] by disclosing a value of dSNR is computed for a window of two to ten cardiac cycles and this value is used in calculating a validity metric for all cardiac cycles within the window [see 0097].
Regarding claims 23, 35, Brockway et al disclose wherein the validity threshold is further based on one or more signals received from photoplethysmography devices worn by users having at least a
shared one of the weight, the height, or the particular health condition (arrhythmia event) of the user [see 0061-0064, 0079-0080] by disclosing a confidence value is computed as a function of the SNR, and the detected cardiac event is classified as valid in response to said confidence signal exceeding a predetermined first threshold. Such confidence values may, for example, make up part of a confidence signal that includes one or more such values. In addition, the confidence value may be computed based upon the SNR, morphology of the signal and a pattern of feature points in the signal [see 0061].
Regarding claim 24, Brockway et al disclose wherein the signal validity classification system is
configured to compare the validity score (confidence value) to the validity threshold (confidence threshold) to determine whether the one or more signals are valid [see 0061-0062, 0157, 0115];
Brockway et al don’t disclose subsequently whether the photoplethysmography device is correctly positioned on the user.
Nonetheless, Lisogurski et al disclose whether the photoplethysmography device is correctly positioned on the user [see 0178-0179] by disclosing a calibration routine can be performed which establishes measurement thresholds (validity threshold) to indicate when probe 1610 is placed on tissue 1640 or off of tissue 1640 and measurement equipment can detect when probe 1610 has fallen off or been removed from tissue 1640 and alert monitoring personnel accordingly [see 0178-0179].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Brockway et al and Lisogurski et al by determining whether the photoplethysmography device is correctly positioned on the user; to enhance physiological measurements [see 0164, Lisogurski et al]
Regarding claim 26, Brockway et al disclose wherein the validity threshold is further based on one or a combination of:
a device type of the photoplethysmography device,
medical signs (e.g., blood pressure, flow, or ECG) being measured by the photoplethysmography device [see 0124, 0197];
or
a desired rate of achieving true positive results.
Regarding claims 28, 37, Brockway et al don’t disclose wherein the sensor array comprises a plurality of transmitters and receivers.
Nonetheless, Lisogurski et al disclose wherein the sensor array comprises a plurality of transmitters and receivers [see 0113, fig 3].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Brockway et al and Lisogurski et al by using a plurality of transmitters and receivers; so that measurements can be taken at different location if desired.
Regarding claims 29, 38, Brockway et al don’t disclose wherein the signal validity classification system is configured to, at a remote location from the photoplethysmography device,
at least one of:
receive a signal generated at the photoplethysmography device, determine whether the one or more signals received by the photoplethysmography device are valid, allow for remote control of operation of the photoplethysmography device,
or
deactivate parts of the photoplethysmography device.
Nonetheless, Lisogurski et al disclose deactivate parts of the photoplethysmography device [see 0118, fig 10] by disclosing measurement system can turn off optical emitter elements of optical sensor 1010, such as removing power from a laser diode or LED portion of optical sensor 1010 that emits optical signal 1031. By turning off the power to the emitter portion of optical sensor 1010, the measurement system can save power and allow associated equipment to operate in a low power mode, or a battery-save mode [see 0118].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Brockway et al and Lisogurski et al by deactivate parts of the photoplethysmography device; the measurement system can save power and allow associated equipment to operate in a low power mode, or a battery-save mode [see 0118].
Regarding claims 30, 39, Brockway et al don’t disclose wherein the photoplethysmography device is a wrist-worn device and an energy transmitter configured to project energy toward a wrist of the user.
Nonetheless, Lisogurski et al disclose the photoplethysmography device is a wrist-worn device [see 0084].
an energy transmitter (optical emitter) configured to project energy toward a wrist of the user [see 0122, 0167] by disclosing Optical sensor 1010 is configured to emit and detect optical signal 1030 in finger 1020 to determine a PPG waveform [see 0113].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Brockway et al and Lisogurski et al by using a wrist-worn device and an energy transmitter configured to project energy toward a wrist of the user; to provide a compact device.
Regarding claim 31, Brockway et al don’t disclose wherein the energy transmitter is configured to project the energy toward the wrist of the user at a set of wavelengths at least one of:
sequentially
or
periodically during a predetermined time period.
Nonetheless, Lisogurski et al disclose wherein the energy transmitter is configured to project the energy toward the wrist [see 0084, 0122] of the user at a set of wavelengths sequentially [see 0043, 0097, 0167] by disclosing one or more optical wavelengths can be used by optical node 180 to measure tissue 140, and the one or more optical wavelengths can be selected based on various physiological factors such as 660 nm and 808 nm [see 0043] and further disclose a sequential measurement [see 0077].
Optical sensor 1010 is configured to emit and detect optical signal 1030 in finger 1020 to determine a PPG waveform [see 0113].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Brockway et al and Lisogurski et al by projecting the energy toward the wrist of the user at a set of wavelengths sequentially; the accuracy of vital sign monitoring can be improved. This is crucial for long-term monitoring, as the quality of the signals can fluctuate over time.
Regarding claims 32, 40, Brockway et al don’t disclose deactivate one or more components of the photoplethysmography device responsive to determining that the one or more signals are invalid.
Nonetheless, Lisogurski et al disclose deactivate one or more components of the photoplethysmography device responsive to determining that the one or more signals are invalid [see 0118, fig 10, 0122] by disclosing measurement system can turn off optical emitter elements of optical sensor 1010, such as removing power from a laser diode or LED portion of optical sensor 1010 that emits optical signal 1031. By turning off the power to the emitter portion of optical sensor 1010, the measurement system can save power and allow associated equipment to operate in a low power mode, or a battery-save mode [see 0118].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Brockway et al and Lisogurski et al by deactivating parts of the photoplethysmography deactivate one or more components of the photoplethysmography device responsive to determining that the one or more signals are invalid; the measurement system can save power and allow associated equipment to operate in a low power mode, or a battery-save mode [see 0118].
Claim(s) 25, 27 are rejected under 35 U.S.C. 103 as being unpatentable over Brockway et al (Pub. No.: US 2013/0289424) in view of Lisogurski et al (Pub, No.: US 2015/0157269) and applied to claims 21, 33 above and further in view of Burg et al (Pub. No.: US 2015/0313484).
Regarding claims 25, 27, Brockway et al disclose wherein the validity threshold is pre-set based on a
specific number of true positive results for determining signal validity and wherein the validity threshold is set to achieve a true positive result determination rate of 99%.
Nonetheless, Burg et al disclose wherein the validity threshold is pre-set based on a specific number of true positive results for determining signal validity and wherein the validity threshold is set to achieve a true positive result determination rate of 99% [see 0092].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Brockway et al, Lisogurski et al and Burg et al by having validity threshold set to achieve a true positive result determination rate of 99%; to perform a more precise determination and validate the overall result.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/Primary Examiner, Art Unit 3797
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