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 .
Applicant’s election without traverse of Invention I, claims 1-14, in the reply filed on 11/20/2025 is acknowledged.
Claims 1-14 are pending for examination. Claims 15-20 are cancelled.
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 1-2, 6, 9-10, and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mannheimer et al. (USPN 5,218,962, hereinafter Mannheimer ‘962). In regard to claim 1, Mannheimer ‘962 discloses a method for performing calibration of a wearable device (calibration and probes, Figs. 1-9 and associated descriptions), comprising: receiving, from the wearable device, a first measure of oxygen saturation associated with a user based at least in part on a first oxygen saturation measurement (data from elements 118 and/or 134, Figs. 2-3 and associated descriptions), wherein the first oxygen saturation measurement is performed at a first anatomical feature of the user (element 118, Fig. 2 and associated descriptions; one of the tissue areas associated with different probe configurations, Figs. 4 and 6-9 and associated descriptions); receiving, from the wearable device, a second measure of oxygen saturation associated with the user based at least in part on a second oxygen saturation measurement (data from elements 122 and/or 138, Figs. 2-3 and associated descriptions), wherein the second oxygen saturation measurement is performed at a second anatomical feature of the user (element 122, Fig. 2 and associated descriptions; another one of the tissue areas associated with different probe configurations, Figs. 4 and 6-9 and associated descriptions); determining an oxygen saturation calibration based at least in part on comparing the first measure of oxygen saturation and the second measure of oxygen saturation (elements 142/143, Fig. 3 and associated descriptions; a confidence value… differences of two measurements…weighting factor, Col 5 lines 29-59); and calibrating the second measure of oxygen saturation according to the determined oxygen saturation calibration (calibrate the Sat2 to calculate a final saturation value based on the a confidence value/ differences/ weighting factor, Col 5 lines 29-59; Fig. 3 and associated descriptions).
In regard to claim 2, Mannheimer ‘962 discloses causing a graphical user interface of a user device to display an indication of the calibrated second measure of oxygen saturation associated with the user (element 114, Figs. 2-3 and associated descriptions; final oxygen saturation value…display, Col 3 line 22 – Col 4 line 3).
In regard to claim 6, Mannheimer discloses calibrating the second measure of oxygen saturation comprises: filtering the second oxygen saturation measurement based at least in part on a position of the wearable device, an orientation of the wearable device, a pressure applied to the wearable device, or any combination thereof, wherein the second measure of oxygen saturation is based at least in part on the filtering (when Sat1 is measured according to Fig. 6 and Sat2 is measured according to Fig. 7, the Sat2 is rejected when the difference is larger than ẟ, e.g. a position of the wearable device, an orientation of the wearable device, a pressure applied to the wearable device of Fig. 7, Col 5 lines 29-59).
In regard to claim 9, Mannheimer ‘962 discloses determining the oxygen saturation calibration comprises: determining a difference between the first measure of oxygen saturation and the second measure of oxygen saturation, wherein the oxygen saturation calibration is further based at least in part on the difference (Fig. 3 and associated descriptions; a confidence value… differences of two measurements…weighting factor, Col 5 lines 29-59).
In regard to claim 10, Mannheimer ‘962 discloses the oxygen saturation calibration is based at least in part on a pulse rate of the user, a signal interference value for the second oxygen saturation measurement, an environmental factor, accelerometer data, pressure data, or any combination thereof (The confidence value may be a function of the difference between the two measurements, optical signal quality, correlation between the optical pulse rate and a measured ECG signal, or other factors, Col 5 lines 29-37).
In regard to claim 12, Mannheimer ‘962 discloses the first anatomical feature and the second anatomical feature are associated with different localities of a same human body part of the user (under the same probe area, Figs. 4 and 8 and associated descriptions).
In regard to claim 13, Mannheimer ‘962 discloses the first anatomical feature is associated with a first human body part of the user and the second anatomical feature is associated with a second human body part of the user (separate probes, Fig. 9 and associated descriptions).
Claims 1-2, 6, 10, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mannheimer (USPN 5,782,756, hereinafter Mannheimer ‘756). In regard to claim 1, Mannheimer ‘756 discloses a method for performing calibration of a wearable device (Figs. 1 and 4-7 and associated descriptions), comprising: receiving, from the wearable device, a first measure of oxygen saturation associated with a user based at least in part on a first oxygen saturation measurement (Steps A-B and a first pair of wavelengths in Step C, Fig. 6 and associated descriptions), wherein the first oxygen saturation measurement is performed at a first anatomical feature of the user (different wavelengths have different penetration depths, Col 7 lines 20-32; Col 8 line 28 – Col 9 line 25); receiving, from the wearable device, a second measure of oxygen saturation associated with the user based at least in part on a second oxygen saturation measurement (Steps A-B and a second pair of wavelengths in Step D, Fig. 6 and associated descriptions), wherein the second oxygen saturation measurement is performed at a second anatomical feature of the user (different wavelengths have different penetration depths, Col 7 lines 20-32; Col 8 line 28 – Col 9 line 25); determining an oxygen saturation calibration based at least in part on comparing the first measure of oxygen saturation and the second measure of oxygen saturation (difference between the first and second estimates, Step E, Fig. 6 and associated descriptions; equation 7 and associated descriptions in Col 10; equations 11-14 and associated descriptions in Col 11) and calibrating the second measure of oxygen saturation according to the determined oxygen saturation calibration (Step E, Fig. 6 and associated descriptions; equation 8a and associated descriptions in Col 10; equations 11-14 and associated descriptions in Col 11).
In regard to claim 2, Mannheimer ‘756 discloses causing a graphical user interface of a user device to display an indication of the calibrated second measure of oxygen saturation associated with the user (element 30, Fig. 5 and associated descriptions).
In regard to claim 9, Mannheimer ‘756 discloses determining the oxygen saturation calibration comprises: determining a difference between the first measure of oxygen saturation and the second measure of oxygen saturation, wherein the oxygen saturation calibration is further based at least in part on the difference (Step E, Fig. 6 and associated descriptions; equation 8a and associated descriptions in Col 10; equations 11-14 and associated descriptions in Col 11).
In regard to claim 12, Mannheimer ‘756 discloses the first anatomical feature and the second anatomical feature are associated with different localities of a same human body part of the user (Figs 1 and 4 and associated descriptions; different wavelengths have different penetration depths, Col 7 lines 20-32; Col 8 line 28 – Col 9 line 25).
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.
Claims 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Mannheimer ‘962 as applied to claims 1-2, 6, 9-10, and 12-13 above, and further in view of LeBoeuf et al. (USPGPUB 2019/0380655). In regard to claim 11, Mannheimer ‘962 discloses all the claimed limitations except the first oxygen saturation measurement corresponds to a first sampling rate and the second oxygen saturation measurement corresponds to a second sampling rate different from the first sampling rate.
LeBoeuf teaches a pulse oximeter (Figs. 1-9 and associated descriptions; pulse oximetry, [0088]) comprises to change the signal analysis frequency/ sampling rate according to the change of user’s activity (Figs. 6-7A and associated descriptions) or the change in environmental conditions (Figs. 8-9 and associated descriptions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method (Mannheimer ‘962) to incorporate the adjustments of signal analysis frequency/ sampling rate and associated steps/functions/elements as taught by LeBoeuf, since both devices are pulse oximetry systems and one of ordinary skill in the art would have recognized that changing signal analysis frequency/ sampling rate according to activities of the user and/or environmental conditions may allow or finer, more accurate sensor data to be collected during periods of rapid body activity or reducing power usage during inactivity (see LeBoeuf). The rationale would have been to change signal analysis frequency/ sampling rate when activity and/or environmental conditions changed between the first and second oxygen saturation measurements.
In regard to claim 14, Mannheimer ‘962 as modified by LeBoeuf discloses all the claimed limitations except the wearable device comprises a wearable ring device. LeBoeuf further teaches the wearable pulse oximetry sensor can be a wearable ring device (Figs. 3A-3B and associated descriptions). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the probe configuration(s) with the wearable ring configuration to yield predictable results, since one of ordinary skill in the art would have recognized that wearable ring configuration is an alternative equivalent configuration for pulse oximetry measurements. The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
Allowable Subject Matter
Claims 3-5 and 7-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: In regard to claims 3, 5 and 7-8, the prior art of record does not teach or suggest “the first oxygen saturation measurement is performed according to a set of orientations of the wearable device, the method comprising: determining an orientation of the wearable device based at least in part on the second oxygen saturation measurement, wherein the oxygen saturation calibration is in accordance with the orientation of the wearable device”; “the first oxygen saturation measurement is performed according to a set of forces applied to an exterior surface of the wearable device, the set of forces changing a first distance between the wearable device and the first anatomical feature of the user, a second distance between the wearable device and the second anatomical feature of the user, or both, the method comprising: determining a force applied to the exterior surface of the wearable device based at least in part on the second oxygen saturation measurement, wherein the oxygen saturation calibration is in accordance with the force”; “the first measure of oxygen saturation is received at a first time, the method comprising: receiving, from the wearable device, a third measure of oxygen saturation associated with the user based at least in part on a third oxygen saturation measurement performed at a second time, wherein a duration between the first time and the second time satisfies a threshold; determining an updated oxygen saturation calibration based at least in part on comparing the third measure of oxygen saturation and the second measure of oxygen saturation; and calibrating the second measure of oxygen saturation according to the determined updated oxygen saturation calibration”; “and “generating a data structure based at least in part on comparing the first measure of oxygen saturation and the second measure of oxygen saturation, the data structure mapping one or more measures of oxygen saturation to one or more of a position of the wearable device, an orientation of the wearable device, or a pressure applied to the wearable device, wherein determining the oxygen saturation calibration is further based at least in part on the data structure”, in combination with the other claimed elements/ steps.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Clark et al. (USPN 5,111,817) teaches a wearable ring oximetry device (Figs. 1-2B) comprises receiving a first oxygen saturation measurement when a pressure is applied on the tissue (RLOGEP, steps 106-116, Fig. 3A); receiving a second oxygen saturation measurement when the pressure is released/ off on the tissue (RLOGNP, steps 122-132, Fig. 3B); determining an oxygen saturation calibration based at least in part on comparing the first measure of oxygen saturation and the second measure of oxygen saturation (R, step 134, Fig. 3B; equations 3 and 4 in Col 18) and using the oxygen saturation calibration to calibrate a subsequent optical measurements (Steps 136-146, Fig. 3B). Kiani (USPGPUB 2008/0071155) teaches an oximetry system (Figs. 3-6) comprises receiving a first oxygen saturation measurement at a first tissue site (steps 730 and 732, Fig. 7A); receiving a second oxygen saturation measurement at a second tissue site (steps 750 and 755, Fig. 7A); calculating site difference (step 790, Fig. 7B) and determining a congenital heart disease condition cased on the site difference (steps 794 and 796. Fig. 7B; abstract). Hoarau et al. (USPGPUB 2007/0078316) teaches an oximetry sensor/monitor (Figs. 1-6) comprises an emitter and a detector for oximetry measurements (elements 24 and 26, Figs. 1A-1C); force-sensitive sensors (elements 12 and 14, Figs. 1-2); the monitor is configured to receive and display a first oxygen saturation data (steps 74 and 80 when output from step 78 is NO, Fig. 7); receive a second oxygen saturation data (step 74 when output from step 78 is YES, Fig. 7); compare detected pressure data with a threshold (step 78, Fig. 7); and correct the second oxygen saturation data and display (steps 82 and 86, Fig. 7).
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791