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 .
Claims Accounting
Applicant's arguments, filed 04/27/2026, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 04/27/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 11-12, 15-16, and 18-19 have been amended.
Claims 1-6, 8-16, and 18-20 are the current claims hereby under examination.
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 1-5, 8-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2016/0206247 by Morland et al. – previously cited, hereinafter “Morland”, in view of the Industrial Process Automation Systems, Chapter 17 by Mehta et al. – previously cited, hereinafter “Mehta”, in view of US Patent Publication 2017/0105638 by Kulach – previously cited, hereinafter “Kulach”.
Regarding claim 1, Fig. 8 of Morland teaches a method for hardware noise filtering for a wearable device, comprising: emitting light from a light emitting element (optical emitter 121) of the wearable device (device is placed on either side of tissue 130) based at least in part on a known input signal to the set of light emitting elements (optical emitter 121 converts signals into an optical signal and emits an optical signal into tissue [0027]); measuring, at a photodetector of the wearable device (optical detector 122), an output signal (detected optical signals), wherein the output signal is generated by passing the light emitted from the set of light emitting elements into a material in contact with the wearable device (optical detector detects signals propagated through tissue 130 [0076]); a known environmental noise component of the output signal (reference signal may comprise the physiological parameters of the patient [0064] or an ambient light signal [0077-0080]); and the collection of a plurality of measurements of a physiological phenomenon of a wearer device (Morland, [0073-0074]; sensor elements 820 are configured to monitor various properties of tissue 130 such as pulse rate, respiration rate, and oxygen saturation among other parameters and provide signals indicating these properties. Monitoring comprises a plurality of these measurements over time).
Fig. 8 of Morland does not teach emitting light from a set of light emitting elements and measuring an output signal at a set of photodetectors.
Morland suggests that multiple optical emitters and optical detectors may be used ([0062], [0088]). It would have been obvious to use a set of light emitting elements and a set of photodetectors since it provides more data for observation. Also, the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (See MPEP 2144.04-VI-B).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Morland to emit light from a set of light emitting elements and to measure an output signal at a set of photodetectors, as a plurality of emitting and sensing elements would provide a more comprehensive observation of optical sensing of the material.
Morland does not teach determining a hardware noise component of the output signal based at least in part on a known environmental noise component of the output signal and a comparison of the known input signal to the output signal, wherein the hardware noise component is determined prior to collection of a plurality of measurements of a physiological phenomenon of a wearer of the wearable device; storing the hardware noise component; activating, after storing the hardware noise component, the wearable device to collect the plurality of measurements of the physiological phenomenon of the wearer of the wearable device; and filtering out the hardware noise component from the plurality of measurements based at least in part on previously storing the hardware noise component.
Mehta teaches calibration methods where the calibration error of an instrument may be determined from the difference between the output of the instrument corresponding to its input. Instrument errors can be determined by applying a known signal to the instrument under test and finding the difference between the output indication and the actual value of the measured variable (i.e., known input, Section 17.1.1). Mehta also teaches that the instrument may need to be calibrated for environmental conditions and based on wear or drift from the instrument (i.e., hardware noise) (Section 17.2). Adjustments may then be made to the system by manipulating some part of the input to output relationship (Section 17.5). Calibration to remove errors is important to maintain the credibility of measurements (Section 17.1).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Morland to include determining a hardware noise component of the output signal based at least in part on a known environmental noise component of the output signal and a comparison of the known input signal to the output signal; and storing the hardware noise component to enable a proper calibration and maintain the credibility of measurements, as taught by Mehta (Section 17.1). It would be prima facie obvious to one of ordinary skill in the art to perform the calibration (i.e., determine the hardware noise component) based on the ambient light signal as the ambient light signal is present when the light emitting elements are on or off. Therefore, if the ambient light signal must be present when determining the hardware noise, and any determination of the hardware noise is also based on the ambient light signal. Although the light emitting elements are not on during the determination of the ambient light signal, the light emitting elements must be on during the determination of a calibration signal to compare the known input to the output, as taught by Mehta. It is further noted that the system of Morland uses the adaptive filtering technique to sum a cancellation signal to account for errors. Par. [0077] of Morland describes how the ambient light signal can be used as a reference signal and is collected during “dark” timeframes (i.e., when the optical emitter 121 is not on). Morland also teaches that multiple reference signals (e.g., noise components) can be utilized to filter the optical measurements ([0057, 0088]). Therefore, to use the ambient light signal and any other previously collected reference signals (such as the calibration signals of Mehta) as the reference signal, the ambient light signal (i.e., noise component) must be determined before collection of a plurality of measurements of the physiological phenomenon, and the wearable device must be activated to collect the plurality of measurements of a physiological phenomenon of a wearer of the wearable device after storing the hardware noise component. Further, the method must filter out the hardware noise component from the plurality of measurements of the physiological phenomenon, based at least in part of previously storing the hardware noise component after activating the wearable device to collect the plurality of measurements of the physiological phenomenon of the wearer of the wearable device.
The combination of Morland and Mehta does not teach storing the hardware noise component in a memory on the wearable device for collecting the plurality of measurements of the physiological phenomenon of the wearer of the wearable device.
Kulach teaches a method of using a wearable device equipped with a set of light emitting elements and a set of photodetectors configured to generate a photoplethysmogram signal. Reference values based on the expected noise levels for the device may be determined for the specific device based on its hardware and stored in the memory of the wearable device ([0032]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Morland in view of Mehta to include storing the hardware noise component in a memory on the wearable device for collecting the plurality of measurements of the physiological phenomenon of the wearer of the wearable device, as taught by Kulach. It is noted that the noise component must be collected and stored, as described above, before it is used to filter the PPG signal, and therefore must be stored in the combination of Morland and Mehta. Therefore, the modification of Morland and Mehta in view of Kulach comprises combining prior art elements according to known methods to yield predictable results. See MPEP 2143-I-A.
Regarding claim 2, the combination of Morland, Mehta, and Kulach teaches the method of claim 1, wherein determining the hardware noise component comprises filtering out the known environmental noise component from the output signal. To determine a hardware noise component, the known environmental noise (i.e., ambient light signal) must be subtracted from the known input and known output, as the ambient light signal is a known noise component. Therefore, the contribution of the ambient light signal can be accounted for in determining the hardware noise component.
Regarding claim 3, the combination of Morland, Mehta, and Kulach teaches the method of claim 1, wherein the known environmental noise component comprises ambient light noise (Morland, [0077-0080]; reference signal may comprise an ambient light signal), motion artifact noise (Morland, [0077]; reference signal derived from ambient light signal can be used as a reference signal for motion noise), physiological phenomenon noise (Morland, [0064]; the reference signal can be based on physiological parameters of the patient such as pulse rates, breathing rates, or heart rate parameters), or a combination thereof.
Regarding claim 4, the combination of Morland, Mehta, and Kulach teaches the method of claim 3, wherein the physiological phenomenon noise comprises a heart rate (Morland, [0064]; the reference signal can be based on the heart rate parameters of the patient), an oxygen saturation level, a blood pressure, or a combination thereof.
Regarding claim 5, the combination of Morland, Mehta, and Kulach teaches the method of claim 1, further comprising: determining the known environmental noise component based at least in part on one or more sensor measurements from the wearable device (Morland, [0077]; The ambient light reference signal is based on measurements from the optical detector).
Regarding claim 8, the combination of Morland, Mehta, and Kulach teaches the method of claim 1, further comprising: performing a plurality of measurements using the set of light emitting elements and the set of photodetectors wherein each measurement of the plurality of measurements corresponds to a different measurement parameter configuration (Mehta, Section 17.5; The multiple point test procedure comprises setting a known input to the instrument, determining the actual (or reference) value and reading the output of the instrument. This process is repeated for a series of different input values (i.e., measurement parameter configuration).); and determining one or more hardware noise values for each measurement parameter configuration (Mehta, Section 17.5; each instrument output is a hardware noise value, and one is obtained for each input value (i.e., measurement parameter configuration)).
Regarding claim 9, the combination of Morland, Mehta, and Kulach teaches the method of claim 8, further comprising: sorting the one or more hardware noise values for each measurement configuration (Mehta, Section 17.5, each of the different input values is in a series) to obtain a measurement parameter configuration range satisfying a threshold measurement accuracy value (Mehta, Section 17.5; The multiple point test procedure comprises repeating the calibration for a series of different input values to determine the instrument’s accuracy, and testing the instrument to verify that it is operating within specification (i.e., satisfying a threshold measurement accuracy value) over the defined operating range (i.e., a measurement parameter configuration range)); but does not teach storing the measurement parameter configuration range.
Section 17.5 of Mehta teaches that the calibration verifies the instrument is within specification over the defined operating range (i.e., measurement parameter configuration range). It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by the combination of Morland, Mehta, and Kulach to include storing the measurement parameter configuration range such that the wearable device only operates within the measurement parameter configuration range, as this is the range that the wearable device would be verified for, as taught by Mehta, Section 17.5. It is noted that in the combination of Morland, Mehta, and Kulach, as applied to claim 1, the hardware noise component is stored in a memory component, therefore the measurement parameter configuration range would also be stored in the memory component.
Regarding claim 10, the combination of Morland, Mehta, and Kulach teaches the method of claim 1, wherein the output signal corresponds to a plurality of signal paths associated with the set of light emitting elements and the set of photodetectors. As applied in claim 1, the combination of Morland, Mehta, and Kulach results in a plurality of emitting elements and photodetectors. Any combination of placements of multiple emitting elements and photodetectors will result in a plurality of signal paths from the emitting elements to the photodetectors, as the emitters and the photodetectors cannot be in the same position.
Regarding claim 11, the combination of Morland, Mehta, and Kulach teaches an apparatus for hardware noise filtering for a wearable device (Morland, Fig. 10), comprising:
at least one processor (Morland, Fig. 10; processing circuitry 1021); at least one memory coupled with the at least one processor (Morland, Fig. 10; storage system 1022); and instructions stored in the at least one memory and executable by the at least one processor (Morland, [0086-0088]; Software 1030 is stored in the storage system and can carry out the functions of measurement system 810 (i.e., perform physiological measurements, selectively drive detection sensors and emitters, receive signals representative of optical measurements, processes the received characteristics of optical and reference signals to determine physiological parameters, adaptively filter optical data based on reference signals, spectrally subtract optical and reference signals from each other, and otherwise reduce motion noise in optical measurements using ambient light measurements, among other operations)) to cause the apparatus to:
emit light from a set of light emitting elements of the wearable device based at least in part on a known input signal to the set of light emitting elements (See the rejection of claim 1);
measure, at a set of photodetectors of the wearable device, an output signal, wherein the output signal is generated by passing the light emitted from the set of light emitting elements into a material in contact with the wearable device (See the rejection of claim 1);
determine a hardware noise component of the output signal based at least in part on a known environmental noise component of the output signal and a comparison of the known input signal to the output signal, wherein the hardware noise component is determined prior to collection of a plurality of measurements of a physiological phenomenon of a wearer of the wearable device (See the rejection of claim 1),
store the hardware noise component in a memory component on the wearable device for collecting the plurality of measurements of the physiological phenomenon of the wearer of the wearable device (See the rejection of claim 1);
activate, after storing the hardware noise component, the wearable device to collect the plurality of measurements of the physiological phenomenon of the wearer of the wearable device (See the rejection of claim 1); and
filter out, after activating the wearable device to collect the plurality of measurements of the physiological phenomenon of the wearer of the wearable device, the hardware noise component from the plurality of measurements of the physiological phenomenon based at least in part on previously storing the hardware noise component (See the rejection of claim 1).
Regarding claim 12, the combination of Morland, Mehta, and Kulach teaches the apparatus of claim 11, wherein the instructions to determine the hardware noise component are executable by the at least one processor to cause the apparatus to: filter out the known environmental noise component from the output signal. To determine a hardware noise component, the known environmental noise (i.e., ambient light signal) must be subtracted from the known input and known output, as the ambient light signal is a known noise component. Therefore, the contribution of the ambient light signal can be accounted for in determining the hardware noise component.
Regarding claim 13, the combination of Morland, Mehta, and Kulach teaches the apparatus of claim 11, wherein the known environmental noise component comprises ambient light noise (Morland, [0077-0080]; reference signal may comprise an ambient light signal), motion artifact noise (Morland, [0077]; reference signal derived from ambient light signal can be used as a reference signal for motion noise), physiological phenomenon noise (Morland, [0064]; the reference signal can be based on physiological parameters of the patient such as pulse rates, breathing rates, or heart rate parameters), or a combination thereof.
Regarding claim 14, the combination of Morland, Mehta, and Kulach teaches the apparatus of claim 13, wherein a physiological phenomenon corresponding to the physiological phenomenon noise comprises a heart rate (Morland, [0064]; the reference signal can be based on the heart rate parameters of the patient), an oxygen saturation level, a blood pressure, or a combination thereof.
Regarding claim 15, the combination of Morland, Mehta, and Kulach teaches the apparatus of claim 11, wherein the instructions are further executable by the at least one processor to cause the apparatus to: determine the known environmental noise component based at least in part on one or more sensor measurements from the wearable device (Morland, [0077]; The ambient light reference signal is based on measurements from the optical detector).
Regarding claim 18, the combination of Morland, Mehta, and Kulach teaches the apparatus of claim 11, wherein the instructions are further executable by the at least one processor to cause the apparatus to: perform a plurality of measurements using the set of light emitting elements and the set of photodetectors wherein each measurement of the plurality of measurements corresponds to a different measurement parameter configuration (Mehta, Section 17.5; The multiple point test procedure comprises setting a known input to the instrument, determining the actual (or reference) value and reading the output of the instrument. This process is repeated for a series of different input values (i.e., measurement parameter configuration).); and determine one or more hardware noise values for each measurement parameter configuration (Mehta, Section 17.5; each instrument output is a hardware noise value, and one is obtained for each input value (i.e., measurement parameter configuration)).
Regarding claim 19, the combination of Morland, Mehta, and Kulach teaches the apparatus of claim 18, wherein the instructions are further executable by the at least one processor to cause the apparatus to: sort the one or more hardware noise values for each measurement configuration (Mehta, Section 17.5, each of the different input values is in a series) to obtain a measurement parameter configuration range satisfying a threshold measurement accuracy value (Mehta, Section 17.5; The multiple point test procedure comprises repeating the calibration for a series of different input values to determine the instrument’s accuracy, and testing the instrument to verify that it is operating within specification (i.e., satisfying a threshold measurement accuracy value) over the defined operating range (i.e., a measurement parameter configuration range)); but does not teach storing the measurement parameter configuration range.
Section 17.5 of Mehta teaches that the calibration verifies the instrument is within specification over the defined operating range (i.e., measurement parameter configuration range). It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the apparatus taught by Morland in view of Mehta to include storing the measurement parameter configuration range such that the wearable device only operates within the measurement parameter configuration range, as this is the range that the wearable device would be verified for, as taught by Mehta, Section 17.5. It is noted that in the combination of Morland, Mehta, and Kulach, as applied to claim 1, the hardware noise component is stored in a memory component, therefore the measurement parameter configuration range would also be stored in the memory component.
Regarding claim 20, the combination of Morland, Mehta, and Kulach teaches a non-transitory computer-readable medium storing code (Morland, storage system 1022, storing software 1030) for hardware noise filtering for a wearable device, the code comprising instructions executable by a processor to:
emit light from a set of light emitting elements of the wearable device based at least in part on a known input signal to the set of light emitting elements (See the rejection of claim 1);
measure, at a set of photodetectors of the wearable device, an output signal, wherein the output signal is generated by passing the light emitted from the set of light emitting elements into a material in contact with the wearable device (See the rejection of claim 1);
determine a hardware noise component of the output signal based at least in part on a known environmental noise component of the output signal and a comparison of the known input signal to the output signal, wherein the hardware noise component is determined prior to collection of a plurality of measurements of a physiological phenomenon of a wearer of the wearable device (See the rejection of claim 1),
store the hardware noise component at a memory component at the wearable device (See the rejection of claim 1);
activate, after storing the hardware noise component, the wearable device to collect the plurality of measurements of the physiological phenomenon of the wearer of the wearable device (See the rejection of claim 1); and
filter out the hardware noise component from the plurality of measurements based at least in part on previously storing the hardware noise component (See the rejection of claim 1).
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Morland in view of Mehta in view of Kulach, as applied to claims 1 and 16, in view of US Patent Publication 2004/0082070 by Jones et al. – previously cited, hereinafter “Jones”.
Regarding claim 6, the combination of Morland, Mehta, and Kulach teaches the method of claim 1, further comprising: determining the known environmental noise component based at least in part on an environmentally controlled calibration setup (Morland, [0077]; the environmentally controlled calibration setup includes the control of the emitting elements to account for only ambient light and experimentally controlling of motion to isolate the effects of motion). The combination of Morland, Mehta, and Kulach does not teach wherein the material in contact with the wearable device comprises an artificial material configured to mimic an optical property of human tissue.
Jones teaches an optically similar reference sample (OSRS) used for the calibration of optical systems measuring bodily tissues (Abstract). The OSRS as taught by Jones can be reproducible over time and can be used to capture variation present in the optical system so that measurement performance can be maintained [0004].
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the experimentally controlled setup taught by the combination of Morland, Mehta, and Kulach to include the material in contact with the wearable device to comprise an artificial material configured to mimic an optical property of human tissue to capture variation present in the optical system so that measurement performance can be maintained, as taught by Jones ([0004]).
Regarding claim 16, the combination of Morland, Mehta, and Kulach teaches the apparatus of claim 11, wherein the instructions are further executable by the at least one processor to cause the apparatus to: determine the known environmental noise component based at least in part on an environmentally controlled calibration setup (Morland, [0077]; the environmentally controlled calibration setup includes the control of the emitting elements to account for only ambient light and experimentally controlling of motion to isolate the effects of motion). The combination of Morland, Mehta, and Kulach does not teach wherein the material in contact with the wearable device comprises an artificial material configured to mimic an optical property of human tissue.
Jones teaches an optically similar reference sample (OSRS) used for the calibration of optical systems measuring bodily tissues (Abstract). The OSRS as taught by Jones can be reproducible over time and can be used to capture variation present in the optical system so that measurement performance can be maintained [0004].
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the experimentally controlled setup taught by the combination of Morland, Mehta, and Kulach to include the material in contact with the wearable device to comprise an artificial material configured to mimic an optical property of human tissue to capture variation present in the optical system so that measurement performance can be maintained, as taught by Jones ([0004]).
Response to Arguments
Applicant’s arguments, filed 04/27/2026 have been fully considered.
Applicant’s arguments that Mehta is directed towards calibration processes and that environmental conditions may be a factor for performing re-calibration is not found persuasive. As cited in the prior Office action and reiterated in this Office action, Mehta teaches calibrating equipment for both environmental factors and for wear or drift in the instrumentation. The calibration for wear or drift is interpreted as hardware noise. While Mehta does teach that calibration should be performed for environmental factors, the environmental noise component relied upon in the rejection of claims 1, 11, and 20 is that taught by Morland.
Applicant’s arguments that Mehta does not teach or suggest that the “output signal’ from the “instrument under test” during the calibration process may include both (1) a known environmental noise component, and (2) a hardware noise component is acknowledged. This argument is not found persuasive, as the arguments are directed towards Mehta, and not the combination of Morland, Mehta, and Kulach. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/NELSON ALEXANDER GLOVER/ Examiner, Art Unit 3791
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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