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 .
Response to Arguments
Applicant's arguments filed 4/29/2026 have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. § 112(a), Applicant states: “that the physiological signal detected by the physiological signal detector can be optimized for the present application, and the physiological signal can be marked for outputting the warning reminder/and/or replaced by the normal signal in the normal period for the optimization process,” apparently stating that the claimed optimization is specifically marking the signal for warning a user or signal replacement. This agrees with the disclosure in ¶¶[0026-0028]. However, although these two “optimization” techniques are acknowledged, they do not appear to properly span the entire breadth of the genus of optimization and therefore are not considered to be a representative number of species sufficient to disclosure the genus.
With respect to the rejections under 35 U.S.C. § 112(b), the amendments and remarks together appear to overcome the rejection, which is therefore withdrawn.
With respect to the rejections under 35 U.S.C. § 103 on p. 10 of the Remarks dated 4/29/2026, Applicant alleges that Ende does not disclose that a compensation step is performed based on analysis of amplitude change and duration of the contact pressure or the physiological parameter.
However, in Ende, the 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).
Applicant interprets “analyze amplitude change and duration of the physiological signal when the pressure value exceeds a predefined pressure threshold and then process…” as a function performed “in response to” the pressure value exceeding the pressure threshold. However, the claims do not require that the analysis of the physiological signal only occurs after a pressure value test, and instead can be met by the analysis and pressure value threshold test performed at the same time as one is occuring “when” the other is also occurring. Additionally, Applicant has claimed no particular causal relationship between the two functions, and neither is interpreted as specifically being performed only in response to the other.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “signal calibration method can determine that the smart wearable device is worn on the wrong finger of the user” and “interacting with the user to relieve stress” and “warning signals relevant to the physiological signal”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
On p. 11 of the Remarks dated, 4/29/2026, Applicant states that “Pushpala does not disclose the signals output by the indicator can be relevant to the …duration of the pressure value” as claimed in claims 7 and 15.
However, in Pushpala, the warning is “relevant” or “pertains” to the duration of the pressure value exceeding the predefined pressure threshold as in ¶[0223] Pushpala discloses “identifying a time period in which sensor dropout is likely to occur or is occurring”.
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 processing a physiological signal for optimization. It’s not clear to the examiner what process or features are described by “optimize” in this claimed context. 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 description of two representative species: marking an affected segment of signal for the purposes of outputting a warning and/or replacement. Although these two “optimization” techniques are acknowledged, they do not appear to properly span the entire breadth of the genus of optimization and therefore are not considered to be a representative number of species sufficient to disclosure the genus.
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 analyzing amplitude change and duration of the physiological signal when the pressure value exceeds a predefined pressure threshold and then process the physiological signal for optimization in response to an analysis result.
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). 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).
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]).
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]).
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 process the physiological signal by marking 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 process the physiological signal by 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.
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 duration of the pressure value exceeding 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 duration of the pressure value exceeding the predefined pressure threshold (¶[0138] output sensor anomaly occurring, and ¶[0221] pressure induced dropout is a sensor anomaly, and the anomaly warning is relevant to duration of the dropout, ¶¶[0222-0223] “identifying a time period in which sensor dropout is likely to occur or is occurring”).
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
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMANDA L STEINBERG/ Examiner, Art Unit 3792
Prosecution Insights