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 Amendment
This office action is responsive to the amendment filed on 7/28/2026. As directed by the amendment, the status of the claim(s) are:
Claim(s) 1-3, 12-14, 19-20 has/have been amended;
Claim(s) 4, 17-18 is/are cancelled;
Claim(s) 21-23 is/are new;
Claim(s) 1-3, 5-16, 19-23 is/are presently pending.
The amendment(s) to the claim(s) is sufficient to overcome the 35 U.S.C. 112 rejection(s) from the previous office action.
The amendment(s) to the claim(s) is sufficient to overcome the 35 U.S.C. 101 rejection(s) from the previous office action.
Response to Arguments
The filing of the terminal disclaimers is sufficient to overcome the outstanding double patenting rejection(s).
Applicant argues on p. 9 that Flower does not disclose steps (c) or (d) as recited:
(c) determining at the external system a first correlation between the qualitative measurements and the first quantitative measurements; and
(d) using the first correlation and a current value of the first quantitative measurement to estimate a first value for the qualitative measurement.
After review, this is not persuasive because Flower does teach taking quantitative measurements such as physiological data and/or duration of sleep, taking qualitative measurements such as through patient survey of how well they slept, and then obtaining a correlation between the two and using this correlation to obtain estimate a first value of qualitative measurement in the form of a sleep quality index or score. See [0141] “scores…may be modified by correlation of the subjective data results against the physiological data for the previous sleep session…”; [0143] “if the correlation of the measured data and feedback data shows…the weighting of that parameter in calculation of the sleep quality index may be modified accordingly. Thus, it will be appreciated that in certain example embodiments, the calculation of sleep quality scores may be adjusted over time by varying the relative weightings and/or presence of certain variables”; [0146] “The sleep quality index may be displayed…as a score out of 10 or 100”. See also Flower Fig. 4, annotated with arrows and highlights:
PNG
media_image1.png
1074
817
media_image1.png
Greyscale
Terminal Disclaimer
The terminal disclaimer filed on 7/28/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patents 10994142 and 12083343 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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) 1-3, 5-16, 19-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moffitt (US 20170056642 A1; 3/2/2017; cited in previous office action) in view of Flower (US 20140076318 A1; 3/20/2014; cited in previous office action).
Regarding claim 1, Moffitt teaches a method useable with an external system in communication with a medical device that executes a program to alleviate a symptom of a patient (Fig. 5; Fig. 7; [0065]; [0086]), the method comprising:
(a) receiving at the external system qualitative measurements as a function of time from the patient, wherein the qualitative measurements comprise subjective input from the patient regarding (i) the symptom, and/or (ii) a status of the patient (Fig. 7; [0014]-[0015]; [0065]; [0069]-[0070]);
(b) receiving at the external system first quantitative measurements taken from the patient as a function of time (Fig. 7; [0012]-[0013]; [0065]; [0069]-[0070]).
Moffitt does not teach (c) determining at the external system a first correlation between the qualitative measurements and the first quantitative measurements; and
(d) using the first correlation and a current value of the first quantitative measurement to estimate a first value for the qualitative measurement.
Note that Moffitt teaches correlations exist ([0070]; [0090]-[0091]). However, Flower teaches in the same field of endeavor (Abstract; Fig. 5-6) (c) determining at the external system a first correlation between the qualitative measurements and the first quantitative measurements (Fig. 5-6; [0141] “scores…may be modified by correlation of the subjective data results against the physiological data for the previous sleep session…”); and
(d) using the first correlation and a current value of the first quantitative measurement to estimate a first value for the qualitative measurement ([0141]-[0143] “if the correlation of the measured data and feedback data shows…the weighting of that parameter in calculation of the sleep quality index may be modified accordingly. Thus, it will be appreciated that in certain example embodiments, the calculation of sleep quality scores may be adjusted over time by varying the relative weightings and /or presence of certain variables”).
Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moffitt to include these features as taught by Flower because this enables proper modification/interpretation of the measured data as feedback for treatment (Fig. 5-6; [0141]-[0143]).
The combination of Moffitt and Flower teaches (e) using the estimated first value of the qualitative measurement to adjust the program executed by the medial device (Moffitt Fig. 7; [0062]; [0065]; Flower Fig. 5; [0144]-[0148]).
Regarding claim 2, the combination of Moffitt and Flower teaches determining at the external system a wellness factor for the patient using the estimated first value of the qualitative measurement (Flower Fig. 5; [0144]-[0148]; sleep quality index or score reads on the recited wellness factor, in this case it also reads on the recited “estimated first value of the qualitative measurement”; in other words they can be the same value; see claim 4 below). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moffitt to include these features as taught by Flower because this enables proper modification/interpretation of the measured data as feedback for treatment (Fig. 5-6; [0141]-[0143]).
Regarding claim 3, the combination of Moffitt and Flower teaches wherein using the estimated first value of the qualitative measurement to adjust the program executed by the medical device comprises using the wellness factor to adjust the program executed by the medical device (Moffitt Fig. 7; [0062]; [0065]; Flower Fig. 5; [0144]-[0148]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moffitt to include these features as taught by Flower because this enables proper modification/interpretation of the measured data as feedback for treatment (Fig. 5-6; [0141]-[0143]).
Regarding claim 5, the combination of Moffitt and Flower teaches transmitting the wellness factor to a clinician of the patient (Flower [0145]; [0150]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moffitt to include these features as taught by Flower because this enables proper modification/interpretation of the measured data as feedback for treatment (Fig. 5-6; [0141]-[0143]).
Regarding claim 6, the combination of Moffitt and Flower teaches wherein the first quantitative measurements are affected by the symptom (Moffitt [0012]-[0013]; [0069]; [0082]), and/or wherein the wellness factor is indicative of the severity of the symptom (Flower [0141]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moffitt to include these features as taught by Flower because this enables proper modification/interpretation of the measured data as feedback for treatment (Fig. 5-6; [0141]-[0143]).
Regarding claim 7, in the combination of Moffitt and Flower, Moffitt teaches wherein the external system comprises a graphical user interface to receive the qualitative measurements from the patient ([0082] “graphical user interface”).
Regarding claim 8, in the combination of Moffitt and Flower, Moffitt teaches wherein the first quantitative measurements are received from at least one sensor of the external device ([0012]-[0013]; [0073]; wearable sensors could be part of external device; alternatively this would be an obvious rearrangement of parts; MPEP 2144.04).
Regarding claim 9, in the combination of Moffitt and Flower, Moffitt teaches wherein the first quantitative measurements are received from at least one sensor of the medical device ([0012]-[0013]; [0069]-[0070]).
Regarding claim 10, in the combination of Moffitt and Flower, Moffitt teaches wherein the first quantitative measurements are received from at least one sensor independent from the external device and the medical device ([0012]-[0013]; [0073]; wearable sensors could be independent of external and medical devices; alternatively this would be an obvious rearrangement of parts; MPEP 2144.04).
Regarding claim 11, the combination of Moffitt and Flower teaches further comprising at steps (b)-(d):
(b) receiving at the external system second quantitative measurements taken from the patient as a function of time (Moffitt Fig. 7; [0012]-[0013]; [0065]; [0069]-[0070]);
(c) determining at the external system a second correlation between the qualitative measurements and the second quantitative measurements (Flower Fig. 4-6; [0141]); and
(d) using the second correlation and a current value of the second quantitative measurement to estimate a second value for the qualitative measurement (Flower [0141]-[0143]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moffitt to include these features as taught by Flower because this enables proper modification/interpretation of the measured data as feedback for treatment (Fig. 5-6; [0141]-[0143]).
Alternatively, this would be an obvious repetition of a known procedure. Merely replicating the treatment step one or more additional times would have been obvious to one of ordinary skill in the art, at least until the desired outcome was achieved. For example, in Perfect Web Tech., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328-29, 92 USPQ2d 1849, 1854 (Fed. Cir. 2009), the Federal Circuit held that mere repetition of a known procedure until success is achieved was merely the logical result of common sense application of the maxim "try, try again." (see MPEP 2143).
Regarding claim 12, the combination of Moffitt and Flower teaches further comprising determining at the external system a wellness factor for the patient using the estimated first and second values of the qualitative measurement (Flower [0141]-[0148]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moffitt to include these features as taught by Flower because this enables proper modification/interpretation of the measured data as feedback for treatment (Fig. 5-6; [0141]-[0143]).
Regarding claim 13, the combination of Moffitt and Flower teaches further comprising determining a first correlation coefficient for the first correlation and a second correlation coefficient for the second correlation (Flower Fig. 4; [0141] “scores…may be modified by correlation of the subjective data results against the physiological data for the previous sleep session…”; [0142]; [0143] “if the correlation of the measured data and feedback data shows…the weighting of that parameter in calculation of the sleep quality index may be modified accordingly. Thus, it will be appreciated that in certain example embodiments, the calculation of sleep quality scores may be adjusted over time by varying the relative weightings and /or presence of certain variables”; [0144]-[0148]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moffitt to include these features as taught by Flower because this enables proper modification/interpretation of the measured data as feedback for treatment (Fig. 5-6; [0141]-[0143]).
Alternatively, this would be an obvious repetition of a known procedure. Merely replicating the treatment step one or more additional times would have been obvious to one of ordinary skill in the art, at least until the desired outcome was achieved. For example, in Perfect Web Tech., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328-29, 92 USPQ2d 1849, 1854 (Fed. Cir. 2009), the Federal Circuit held that mere repetition of a known procedure until success is achieved was merely the logical result of common sense application of the maxim "try, try again." (see MPEP 2143).
Regarding claim 14, the combination of Moffitt and Flower teaches wherein the wellness factor is determined by respectively weighting the estimated first and second values of the qualitative measurement by the first and second correlation coefficients (Flower [0141]-[0148]; note that Flower teaches both weights ([0139]) and correlation ([0141]) and that it would be mathematically equivalent to vary either weights, correlation, and/or both to get the same result; e.g. 0.1[weight] X 100[correlation coefficient] X U[qualitative measurement] is equivalent to 10 X U[qualitative measurement]; see specifically [0143] in which sleep quality index is modified according to varying the relative weightings and/or presence of certain variables). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moffitt to include these features as taught by Flower because this enables proper modification/interpretation of the measured data as feedback for treatment (Fig. 5-6; [0141]-[0143]).
Regarding claim 15, in the combination of Moffitt and Flower, Moffitt teaches wherein the external system comprises a patient external controller (Fig. 6; [0065] “remote control device intended for use by the patient”).
Regarding claim 16, in the combination of Moffitt and Flower, Moffitt teaches wherein the medical device comprises an implantable neurostimulator (Fig. 6; Fig. 9; [0080]) or an external trial stimulator.
Regarding claim 19, Moffitt teaches a medical device system, comprising:
an external device for communicating with a medical device that executes a program to alleviate a symptom of a patient (Fig. 5; Fig. 7; [0065]; [0086]), the external device comprising:
a graphical user interface (GUI) ([0082] “graphical user interface”); and
control circuitry configured to:
(a) receive at the GUI qualitative measurements as a function of time from the patient, wherein the qualitative measurements comprise subjective input from the patient regarding (i) the symptom, and/or (ii) a status of the patient (Fig. 7; [0014]-[0015]; [0065]; [0069]-[0070]);
(b) receive first quantitative measurements taken from the patient as a function of time (Fig. 7; [0012]-[0013]; [0065]; [0069]-[0070]).
Moffitt does not teach (c) determine a first correlation between the qualitative measurements and the first quantitative measurements; and
(d) use the first correlation and a current value of the first quantitative measurement to estimate a first value for the qualitative measurement.
Note that Moffitt teaches correlations exist ([0070]; [0090]-[0091]). However, Flower teaches in the same field of endeavor (Abstract; Fig. 5-6) (c) determine a first correlation between the qualitative measurements and the first quantitative measurements (Fig. 5-6; [0141] “scores…may be modified by correlation of the subjective data results against the physiological data for the previous sleep session…”); and
(d) use the first correlation and a current value of the first quantitative measurement to estimate a first value for the qualitative measurement ([0141]-[0143] “if the correlation of the measured data and feedback data shows…the weighting of that parameter in calculation of the sleep quality index may be modified accordingly. Thus, it will be appreciated that in certain example embodiments, the calculation of sleep quality scores may be adjusted over time by varying the relative weightings and /or presence of certain variables”).
Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Moffitt to include these features as taught by Flower because this enables proper modification/interpretation of the measured data as feedback for treatment (Fig. 5-6; [0141]-[0143]).
The combination of Moffitt and Flower teaches (e) use the estimated first value of the qualitative measurement to adjust the program executed by the medial device (Moffitt Fig. 7; [0062]; [0065]; Flower Fig. 5; [0144]-[0148]).
Regarding claim 20, in the combination of Moffitt and Flower, Moffitt teaches wherein the external device comprises a patient external controller (Fig. 6; [0065] “remote control device intended for use by the patient”).
Regarding claim 21, in the combination of Moffitt and Flower, Moffitt teaches further comprising the medical device (Fig. 5-7).
Regarding claim 22, in the combination of Moffitt and Flower, Moffitt teaches wherein the medical device comprises an implantable stimulator device (Fig. 5-7).
Regarding claim 23, the combination of Moffitt and Flower teaches wherein the control circuitry is programmed with an algorithm which when executed is configured to perform steps (a)-(e) (Moffitt Fig. 3-7; see claim 19 above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bardy (US 20120078064 A1; 3/29/2012) teaches in the same field of endeavor (Fig. 1; [0031]; [0050]) determining at the external system a first correlation between the qualitative measurements and the first quantitative measurements ([0009] “objective “hard” physiological measures and subjective “soft” quality of life and symptom measures and correlating the two”; [0010] “Derived measures are extrapolated…the patients may regularly submit subjective, quality of life and symptom measures to the server system to…correlate with objective health care findings”; [0038]; [0061]).
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 Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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, Niketa Patel can be reached at 571-272-4156. 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.
/JONATHAN T KUO/ Primary Examiner, Art Unit 3792
Prosecution Insights