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 .
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Specification
The disclosure is objected to because of the following informalities: in ¶[0002] there appears to be a typographical error in the phrase “affected by pressured and a smart wearable device.” The examiner suggests “affected by pressure and a smart wearable device”.
Appropriate correction is required.
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some unclear, inexact or verbose terms used in the specification are: optimiz(ing) a physiological signal. It’s not clear to the examiner what process or features are described by “optimize” in this claimed context. There appears to be no further description as to how the signal is affected in an optimization process/step or feature or what the process/step or feature requires. For further examples, what is the signal optimized for? What elements of the signal or signal acquisition are optimized? There appears to be no discussion of signal quality metrics such as signal-to-noise ratio or amplitude, or signal acquisition parameters such as sampling frequency or filtering.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is insufficient disclosure of optimiz(ing) a physiological signal. It’s not clear to the examiner what process or features are described by “optimize” in this claimed context. There appears to be no further description as to how the signal is affected in an optimization process/step or feature or what the process/step or feature requires. For further examples, what is the signal optimized for? What elements of the signal or signal acquisition are optimized? There appears to be no discussion of signal quality metrics such as signal-to-noise ratio or amplitude, or signal acquisition parameters such as sampling frequency or filtering. This optimization appears to be performed by a computer or processor, and is directed to a genus of improving signal acquisition and therefore the specification should include sufficient support to show adequate written description of a representative number of species. Problems satisfying the written description requirement for original claims often occur when claim language is generic or functional, or both. Ariad, 593 F.3d at 1349, 94 USPQ2d at 1171 (“The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant [inventor] has made a generic invention that achieves the claimed result and do so by showing that the applicant [inventor] has invented species sufficient to support a claim to the functionally-defined genus.”). In the instant case there appears to be no description of any representative species whatsoever.
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.
Claims 1-18 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The term “optimize” in claims 1-18 is a relative term which renders the claim indefinite. The term “optimize” 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. For the purposes of examination, any recited improvement in signal acquisition will be considered to meet the requirements of optimizing.
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.
Claim(s) 1-2, 5-6, 8-10, 13-14, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward et al. (U.S. Patent Application Publication No. 2020/0054221) hereinafter referred to as Ward; in view of Van Den Ende et al. (U.S. Patent Application Publication No. 2017/0347957) hereinafter referred to as Ende.
Regarding claim 1, Ward teaches a smart wearable device having a signal calibration function and applied to a finger of a user (¶[0011], finger mountable device, Fig. 2B, ¶[0077] other locations), the smart wearable device comprising:
at least one physiological signal detector adapted to abut against a detection area of the user for detecting a physiological signal (¶[0013] pulse-oximetry sensor positioned to collect PPG derived blood flow data);
at least one pressure detector disposed around the at least one physiological signal detector and adapted to detect a pressure value of the detection area (¶[0013] piezoelectric pressure sensor, Fig. 2B, ¶[0067]); and
an operation processor electrically connected with the at least one physiological signal detector and the at least one pressure detector (¶[0085] wired or wireless, both are considered an electrical connection), the operation processor being adapted to optimize the physiological signal (¶[0019], ¶[0076], ¶[0144]).
Ward does not teach optimizing the physiological signal in response to a pressure value exceeding a predefined pressure threshold.
Attention is brought to the Ende reference, which teaches optimizing a physiological signal in response to a pressure value exceeding a predefined pressure threshold (¶¶[0040-0041] contact pressure exceeds the pressure change threshold, and the sensor pressure actuator is used to optimize the physiological parameter measurement).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the pressure and physiological sensing ring of Ward to include a contact pressure optimization, as taught by Ende, to obtain high quality data even if the subject moves during the measurement process (Ende ¶[0040]).
Regarding claim 2, Ward as modified teaches the smart wearable device of claim 1.
Ward further teaches wherein the at least one pressure detector is disposed adjacent to an outer edge of the at least one physiological signal detector, so that the physiological signal and the pressure value of the detection area are detected by the at least one physiological signal detector and the at least one pressure detector in a respective and simultaneous manner (Fig. 2B, Fig. 14A oximetry sensor components element 1404 and 1408, piezoelectric sensors 1402 are adjacent to the outer edges of the oximetry sensor components).
Regarding claim 5, Ward as modified teaches the smart wearable device of claim 1.
Ende further teaches wherein the operation processor is adapted to further optimize the physiological signal in response to a pressure value exceeding a predefined pressure threshold (¶¶[0040-0041] contact pressure exceeds the pressure change threshold, and the sensor pressure actuator is used to optimize the physiological parameter measurement) and amplitude change of the physiological signal exceeds a predefined physiological threshold (¶[0030], ¶[0064] amplitude change of the physiological signal can identify when the sensor has inappropriately moved and should be compensated for).
Regarding claim 6, Ward as modified teaches the smart wearable device of claim 1.
Ende further teaches wherein the operation processor is adapted to further optimize the physiological signal when the pressure value exceeds the predefined pressure threshold (¶¶[0040-0041] contact pressure exceeds the pressure change threshold, and the sensor pressure actuator is used to optimize the physiological parameter measurement) and duration of amplitude change (¶[0030], ¶[0064] amplitude change of the physiological signal can identify when the sensor has inappropriately moved and should be compensated for) of the physiological signal exceeding a predefined physiological threshold conforms to a predefined period of time (¶[0113] when the amplitude change occurs, the sensor interrupts the light source for a predefined “short period” to detect ambient light exposure before compensating for the change).
Regarding claim 8, Ward as modified teaches the smart wearable device of claim 1.
Ward further teaches wherein the smart wearable device further comprises a plurality of physiological signal detectors and a plurality of pressure detectors, each of the plurality of pressure detectors is disposed adjacent to the outer edge of a corresponding physiological signal detector as a pair, for simultaneously detecting the physiological signal and the pressure value of a corresponding detection area (¶¶[0113-0115], plurality of physiological detectors in multiple types of sensing modalities paired with piezoelectric sensors 1402, Fig. 14A).
Regarding claim 9, Ward as modified teaches the smart wearable device of claim 1.
Ward further teaches wherein the smart wearable device further comprises an acceleration detector electrically connected with the operation processor and adapted to detect an acceleration value of the detection area (¶[0066]), the operation processor is adapted to further optimize the physiological signal when the pressure value exceeds the predefined pressure threshold and the acceleration value exceeds a predefined acceleration threshold (¶[0066] a change in motion, location, orientation triggers optimization in the form of extracting motion artifacts and suppressing or cancelling noise in the raw signal data based on motion data).
Regarding claims 10, 13-14, and 16-18, the claims are directed to substantially the same subject matter as claims 1-2, 5-6, and 8-9 and are rejected under substantially the same sections of Ward and Ende.
Claim(s) 3 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward and Ende as applied to claims 1 and 10 above, and further in view of Pushpala et al. (U.S. Patent Application Publication No. 2021/0321942) hereinafter referred to as Pushpala, and Freeman et al. (U.S. Patent Application Publication No. 2019/0298987) hereinafter referred to as Freeman.
Regarding claims 3 and 11, Ward as modified teaches the smart wearable device/method of claims 1/10.
Ward does not teach wherein the operation processor is adapted to further mark the physiological signal detected in a process of the pressure value exceeding the predefined pressure threshold, and output a warning reminder relevant to the marked physiological signal.
Attention is brought to the Pushpala reference, which teaches wherein the operation processor is adapted to further mark the physiological signal detected in a process of the pressure value exceeding the predefined pressure threshold (¶¶[0222-0223] sensor dropout period identified and/or predicted, in response to conditions indicating “pressure-induced dropout” which is pressure exceeding desired pressure threshold for accurate physiological detection).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the wearable device signal processing of Ward as modified to include marking an inaccurate signal, as taught by Pushpala, to reduce the incidence of erroneous user alerts due to pressure-induced sensor dropout (Pushpala ¶[0223]).
Ward as modified and Pushpala do not teach outputting a warning reminder relevant to the marked physiological signal.
Attention is drawn to the Freeman reference, which teaches outputting a warning reminder relevant to a marked physiological signal (¶[0247] flag signal, and notify user with alert, ¶[0154] alert indicates physiological sensors disengaged therefore relevant to the physiological signal).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the signal processing of Ward as modified to include an output warning reminder, as taught by Freeman, because it reminds the user to remedy any disengaged devices or components (Freeman ¶[0154]).
Claim(s) 4, 7, 12, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ward and Ende as applied to claims 1 and 10 above, and further in view of Pushpala et al. (U.S. Patent Application Publication No. 2021/0321942) hereinafter referred to as Pushpala.
Regarding claims 4 and 12, Ward as modified teaches the smart wearable device/method of claims 1/10.
Ward as modified does not teach wherein the operation processor is adapted to further replace the physiological signal detected in a process of the pressure value exceeding the predefined pressure threshold by the physiological signal detected before the process of the pressure value exceeding the predefined pressure threshold.
Attention is brought to the Pushpala reference, which teaches replacing the physiological signal detected in a process of the pressure value exceeding the predefined pressure threshold by the physiological signal detected before the process of the pressure value exceeding the predefined pressure threshold (¶¶[0222-0223], Figs. 10-12, replacing signal with data predicted from physiological signal detected before the pressure dropout).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the wearable device signal processing of Ward as modified to include marking an inaccurate signal, as taught by Pushpala, to reduce the incidence of erroneous user alerts due to pressure-induced sensor dropout (Pushpala ¶[0223]).
Regarding claims 7 and 15, Ward as modified teaches the smart wearable device/method of claims 1/10.
Ende further teaches wherein the operation processor is adapted to further optimize the physiological signal when the pressure value exceeds the predefined pressure threshold (¶¶[0040-0041] contact pressure exceeds the pressure change threshold, and the sensor pressure actuator is used to optimize the physiological parameter measurement) and duration of amplitude change (¶[0030], ¶[0064] amplitude change of the physiological signal can identify when the sensor has inappropriately moved and should be compensated for) of the physiological signal exceeding a predefined physiological threshold conforms to a predefined period of time (¶[0113] when the amplitude change occurs, the sensor interrupts the light source for a predefined “short period” to detect ambient light exposure before compensating for the change).
Ward as modified does not teach wherein the operation processor is adapted to further output a warning reminder relevant to the predefined pressure threshold.
Attention is brought to the Pushpala reference, which teaches wherein the operation processor is adapted to further mark the physiological signal detected in a process of the pressure value exceeding the predefined pressure threshold (¶¶[0222-0223] sensor dropout period identified and/or predicted, in response to conditions indicating “pressure-induced dropout” which is pressure exceeding desired pressure threshold for accurate physiological detection) and output a warning reminder relevant to the predefined pressure threshold (¶[0138] output sensor anomaly occurring, and ¶[0221] pressure induced dropout is a sensory anomaly).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the wearable device signal processing of Ward as modified to include replacing physiological signal detected during pressure induced dropout sensor anomalies, as taught by Pushpala, to reduce the incidence of erroneous user alerts due to pressure-induced sensor dropout (Pushpala ¶[0223]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2016/0174099 to Goldfain teaches flagging noisy data segments.
U.S. Patent Application Publication No. 2025/0339096 to Robinson teaches optimizing a plurality of sensor parameters based on detecting poor signal quality.
U.S. Patent Application Publication No. 2021/0000347 to Stump teaches using ambient and environmental pressure sensed by a pressure sensor to calibrate and provide context for PPG.
U.S. Patent Application Publication No. 2014/0288390 to Hong et al. teaches optimizing PPG signal acquisition based on acceleration exceeding a threshold.
U.S. Patent Application Publication No. 2020/0337571 to Narasimhan et al. teaches instructing a user to change the sensor environment (finger temperature for a sensing ring) in response to a sensor environment signal exceeding a threshold.
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/AMANDA L STEINBERG/Examiner, Art Unit 3792