DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s amendments merit new grounds for rejection under 35 U.S.C. § 103 in view of Naghavi et al. (U.S. Patent Application Publication No. 2007/0173727). The Naghavi reference teaches determining values comprising performing bidirectional waveform vascular analysis of vascular waveforms to provide vascular function information including data representing vascular condition based on the bidirectional waveform vascular analysis (¶[0088] bidirectional doppler probe located over the radial artery, Fig. 15 element 1902, Fig. 16 doppler vascular waveform data, ¶¶[0088-0089] discusses the vascular condition information that is derived from bidirectional waveform analysis).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the mobile monitoring device of Farringdon as modified to include bidirectional Doppler analysis, as taught by Naghavi, because Naghavi teaches that the Doppler pulse velocity curve can be calibrated to study factors affecting vascular resistance, non-invasively (Naghavi ¶[0089]).
Applicant’s remarks dated 11/20/2025 have been fully considered but are not persuasive as they are directed solely to whether the combination of Farringdon and Castellanos teach the newly amended claim limitations.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim 1-4, and 9-24 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Farringdon et al. (U.S. Patent Application Publication No. 2008/0171943) hereinafter referred to as Farringdon; in view of Castellanos (U.S. Patent Application Publication No. 2006/0229506) hereinafter referred to as Castellanos; in view of Naghavi et al. (U.S. Patent Application Publication No. 2007/0173727) hereinafter referred to as Naghavi.
Regarding claim 1, Farringdon teaches a method comprising:
using one or more sensors (¶[0026]) of a mobile monitoring device (Abstract, wearable), monitoring a user while the user engages in a sedentary activity (p. 19, Table 3, ¶[0135]);
wherein monitoring includes periodically determining values for a plurality of physiologic variables based on the one or more sensors (¶[0026] physiological parameters);
wherein the physiologic variables include at least vascular waveform (¶¶[0103-0105]);
providing the values of the physiologic variables to a computing device (¶[0095]).
Farringdon does teach generally suggesting routines to the user (¶¶[0030-0031]) but does not specify that the report is based on the physiologic variables. Farringdon further does not teach wherein determining values comprises performing bidirectional waveform vascular analysis of the vascular waveforms to provide vascular function information including data representing vascular condition based on the bidirectional waveform vascular analysis.
Attention is drawn to the Castellanos reference, which teaches based on physiology variables, the computing device generating a report that recommends a regimen of one or more actions for the user (¶¶[0057-0058]).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the mobile monitoring device of Farringdon to include recommendations to the user, as taught by Castellanos, because the recommendations improve personal lifestyle choices and habits (Castellanos ¶[0190]).
Farringdon as modified does not teach wherein determining values comprises performing bidirectional waveform vascular analysis of the vascular waveforms to provide vascular function information including data representing vascular condition based on the bidirectional waveform vascular analysis.
Attention is brought to the Naghavi reference, which teaches determining values comprising performing bidirectional waveform vascular analysis of vascular waveforms to provide vascular function information including data representing vascular condition based on the bidirectional waveform vascular analysis (¶[0088] bidirectional doppler probe located over the radial artery, Fig. 15 element 1902, Fig. 16 doppler vascular waveform data, ¶¶[0088-0089] discusses the vascular condition information that is derived from bidirectional waveform analysis).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the mobile monitoring device of Farringdon as modified to include bidirectional Doppler analysis, as taught by Naghavi, because Naghavi teaches that the Doppler pulse velocity curve can be calibrated to study factors affecting vascular resistance, non-invasively (Naghavi ¶[0089]).
Regarding claim 2, Farringdon as modified teaches the method of Claim 1.
Farringdon further teaches wherein the physiologic variables also include metrics indicative of rate of change in heartbeat (¶[0008] heart beat rate, p. 19 Table 2, rise time).
Regarding claim 3, Farringdon as modified teaches the method of Claim 1.
Farringdon further teaches wherein physiologic variables also include metrics indicative of relative condition of endothelium of the user (¶[0104] the tension of the arterial walls, and blood pressure is indicative of relative condition of endothelium of the user).
Regarding claim 4, Farringdon as modified teaches the method of Claim 1.
Farringdon further teaches wherein: the computing device is separate from the mobile monitoring device; the method further includes operatively connecting the mobile monitoring device to the computing device to transfer the values of the physiologic variables to the computer device (¶[0095]).
Regarding claim 9, Farringdon as modified teaches the method of Claim 1.
Farringdon further teaches wherein the physiologic variables further include two or more selected from a group that consists of: blood pressure (¶[0106]), pulse (¶[0105]), respiration (¶[0119]), oxygenation (¶[0105] oximeter), and vascular waveform (¶¶[0103-0105]).
Regarding claim 10, Farringdon teaches a method comprising:
using one or more sensors (¶[0026]) of a mobile monitoring device (Abstract, wearable), monitoring a user while the user engages in a physical activity (p. 19, Table 3, ¶[0135]);
wherein monitoring includes periodically determining measurement values for a plurality of physiologic variables based on the one or more sensors (¶[0026] physiological parameters);
wherein the physiologic variables include at least vascular waveform (¶¶[0103-0105]); and
providing measurement values to a computing device (¶[0095]).
Farringdon does not teach storing goal values, wherein the goal values include a goal value for each of the physiologic variables; providing the measurement values and the goal values to a computing device; based on the measurement values and the goal values, the computing device generating a report that indicates whether goals associated with the goal values have been realized. Farringdon further does not teach wherein determining values comprises performing bidirectional waveform vascular analysis of the vascular waveforms to provide vascular function information including data representing vascular condition based on the bidirectional waveform vascular analysis.
Attention is brought to the Castellanos reference, which teaches storing goal values (¶[0056], ¶[0076], ¶[0085]), wherein the goal values include a goal value for each of the physiologic variables (¶¶[0093-0094] normal vs abnormal physiology including for vascular waveforms); providing the measurement values and the goal values to a computing device (¶[0128]); based on the measurement values and the goal values, the computing device generating a report that indicates whether goals associated with the goal values have been realized (Fig. 2, ¶[0129]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the mobile monitoring device of Farringdon to include goal setting and evaluation, as taught by Castellanos, because Castellanos teaches that goal setting can save time and money in the course of treatment, and increase the skills and effectiveness of the user in reversing or preventing cardiovascular disease (Castellanos ¶[0100]).
Farringdon as modified does not teach wherein determining values comprises performing bidirectional waveform vascular analysis of the vascular waveforms to provide vascular function information including data representing vascular condition based on the bidirectional waveform vascular analysis.
Attention is brought to the Naghavi reference, which teaches determining values comprising performing bidirectional waveform vascular analysis of vascular waveforms to provide vascular function information including data representing vascular condition based on the bidirectional waveform vascular analysis (¶[0088] bidirectional doppler probe located over the radial artery, Fig. 15 element 1902, Fig. 16 doppler vascular waveform data, ¶¶[0088-0089] discusses the vascular condition information that is derived from bidirectional waveform analysis).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the mobile monitoring device of Farringdon as modified to include bidirectional Doppler analysis, as taught by Naghavi, because Naghavi teaches that the Doppler pulse velocity curve can be calibrated to study factors affecting vascular resistance, non-invasively (Naghavi ¶[0089]).
Regarding claim 11, Farringdon as modified teaches the method of Claim 10.
Farringdon further teaches wherein the physiologic variables also include metrics indicative of rate of change in heartbeat (¶[0008] heart beat rate).
Regarding claim 12, Farringdon as modified teaches the method of Claim 10.
Farringdon further teaches wherein physiologic variables also include metrics indicative of relative condition of endothelium of the user (¶[0104] the tension of the arterial walls, and blood pressure is indicative of relative condition of endothelium of the user).
Regarding claim 13, Farringdon as modified teaches the method of Claim 10.
Farringdon further teaches wherein the physiologic variables further include two or more selected from a group that consists of: blood pressure (¶[0106]), pulse (¶[0105]), respiration (¶[0119]), oxygenation (¶[0105] oximeter), and vascular waveform (¶¶[0103-0105]).
Regarding claim 14, Farringdon teaches a method comprising:
using one or more sensors (¶[0026]) of a mobile monitoring device (Abstract, wearable), monitoring a user while the user engages in a physical activity (p. 19, Table 3, ¶[0135]);
wherein monitoring includes periodically determining measurement values for a plurality of physiologic variables based on the one or more sensors (¶[0026] physiological parameters);
wherein the physiologic variables include at least vascular waveform (¶¶[0103-0105]); and
while the user engages in the physical activity (¶[0095] in real time), the mobile monitoring device wirelessly transmitting the measurement values to a computing device (¶[0095]);
based on the measurement values, the computing device generating a report that indicates a state of the person at various points in time during the user's participation in the physical activity (¶[0158]).
Farringdon does not teach the state of the person is a health status of the user. wherein determining values comprises performing bidirectional waveform vascular analysis of the vascular waveforms to provide vascular function information including data representing vascular condition based on the bidirectional waveform vascular analysis.
Attention is brought to the Castellanos reference, which teaches a health status of the user (¶[0058] vascular health analysis).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the mobile monitoring device of Farringdon to include vascular health status of the user, as taught by Castellanos, because it’s useful in achieving stress reduction, addressing weight problems, smoking cessation, and improving personal lifestyle choices and habits (Castellanos ¶[0020]).
Farringdon as modified does not teach wherein determining values comprises performing bidirectional waveform vascular analysis of the vascular waveforms to provide vascular function information including data representing vascular condition based on the bidirectional waveform vascular analysis.
Attention is brought to the Naghavi reference, which teaches determining values comprising performing bidirectional waveform vascular analysis of vascular waveforms to provide vascular function information including data representing vascular condition based on the bidirectional waveform vascular analysis (¶[0088] bidirectional doppler probe located over the radial artery, Fig. 15 element 1902, Fig. 16 doppler vascular waveform data, ¶¶[0088-0089] discusses the vascular condition information that is derived from bidirectional waveform analysis).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the mobile monitoring device of Farringdon as modified to include bidirectional Doppler analysis, as taught by Naghavi, because Naghavi teaches that the Doppler pulse velocity curve can be calibrated to study factors affecting vascular resistance, non-invasively (Naghavi ¶[0089]).
Regarding claim 15, Farringdon as modified teaches the method of Claim 14.
Farringdon further teaches wherein the physiologic variables also include metrics indicative of rate of change in heartbeat (¶[0008] heart beat rate).
Regarding claim 16, Farringdon as modified teaches the method of Claim 14.
Farringdon further teaches wherein physiologic variables also include metrics indicative of relative condition of endothelium of the user (¶[0104] the tension of the arterial walls, and blood pressure is indicative of relative condition of endothelium of the user).
Regarding claim 17, Farringdon as modified teaches the method of Claim 14.
Castellanos further teaches wherein the report includes recommendations of actions that the user may take during the physical activity to improve health status (¶[0058], ¶¶[0101-0102] and ¶¶[0115-0116]).
Regarding claim 18, Farringdon as modified teaches the method of Claim 17.
Castellanos teaches further comprising causing the mobile monitoring device to display the recommendations (¶[0116]).
Regarding claim 19, Farringdon as modified teaches the method of Claim 14.
Farringdon teaches wherein the physiologic variables further include two or more selected from a group that consists of: blood pressure (¶[0106]), pulse (¶[0105]), respiration (¶[0119]), oxygenation (¶[0105] oximeter), and vascular waveform (¶¶[0103-0105]).
Regarding claim 20, Farringdon teaches a method comprising:
using one or more sensors (¶[0026]) of a mobile monitoring device (Abstract, wearable), monitoring a user (p. 19, Table 3, ¶[0135]);
wherein monitoring includes periodically determining measurement values for a plurality of physiologic variables based on the one or more sensors (¶[0026] physiological parameters);
wherein periodically determining measurement values include determining measurement values for at least:
a first time that is prior to admission to a medical facility (¶[0173]); and
a second time that is at or near time of admission to the medical facility (¶[0173], ¶[0177]);
wherein the physiologic variables include at least vascular waveform (¶¶[0103-0105]); and
providing, to a computing device, the measurement values obtained for the first time and the measurement values obtained for the second time (¶[0095], ¶[0174]);
Farringdon teaches a broadly recited diagnosis based on user parameters over time (¶[0174], ¶[0176], ¶[0177]), but does not teach generating a report that includes a diagnosis of an ailment. Farringdon further does not teach wherein determining values comprises performing bidirectional waveform vascular analysis of the vascular waveforms to provide vascular function information including data representing vascular condition based on the bidirectional waveform vascular analysis.
Attention is brought to the Castellanos reference, which teaches generating a report that includes a diagnosis of an ailment (¶¶[0017-0020] evaluating a patient for vascular disease and giving a report with a treatment plan having an indication of vascular disease state).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the mobile monitoring device of Farringdon to include vascular health status of the user, as taught by Castellanos, because it’s useful in achieving stress reduction, addressing weight problems, smoking cessation, and improving personal lifestyle choices and habits (Castellanos ¶[0020]).
Farringdon as modified does not teach wherein determining values comprises performing bidirectional waveform vascular analysis of the vascular waveforms to provide vascular function information including data representing vascular condition based on the bidirectional waveform vascular analysis.
Attention is brought to the Naghavi reference, which teaches determining values comprising performing bidirectional waveform vascular analysis of vascular waveforms to provide vascular function information including data representing vascular condition based on the bidirectional waveform vascular analysis (¶[0088] bidirectional doppler probe located over the radial artery, Fig. 15 element 1902, Fig. 16 doppler vascular waveform data, ¶¶[0088-0089] discusses the vascular condition information that is derived from bidirectional waveform analysis).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the mobile monitoring device of Farringdon as modified to include bidirectional Doppler analysis, as taught by Naghavi, because Naghavi teaches that the Doppler pulse velocity curve can be calibrated to study factors affecting vascular resistance, non-invasively (Naghavi ¶[0089]).
Regarding claim 21, Farringdon as modified teaches the method of Claim 20.
Farringdon further teaches wherein the physiologic variables also include metrics indicative of rate of change in heartbeat (¶[0008] heart beat rate).
Regarding claim 22, Farringdon as modified teaches the method of Claim 20.
Farringdon further teaches wherein physiologic variables also include metrics indicative of relative condition of endothelium of the user (¶[0104] the tension of the arterial walls, and blood pressure is indicative of relative condition of endothelium of the user).
Regarding claim 23, Farringdon as modified teaches the method of Claim 20.
Castellanos further teaches wherein the report further includes a list of one or more proposed actions to treat the ailment (¶[0094]).
Regarding claim 24, Farringdon as modified teaches the method of Claim 20.
Farringdon further teaches wherein the physiologic variables further include two or more selected from a group that consists of: blood pressure (¶[0106]), pulse (¶[0105]), respiration (¶[0119]), oxygenation (¶[0105] oximeter), and vascular waveform (¶¶[0103-0105]).
Claims 5-8 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Farringdon, Castellanos, and Naghavi as applied to claim 1 above, and further in view of Ellis et al. (U.S. Patent Application Publication No. 2004/0102931) hereinafter referred to as Ellis.
Regarding claims 5-8, Farringdon as modified teaches the method of Claim 1.
Farringdon as modified does not teach wherein the one or more actions includes an action that specifies a physical activity and a suggested duration of the physical activity; wherein the one or more actions includes an action that specifies an amount of water to consume; wherein the one or more actions includes an action that specifies an amount of a medication to consume; or wherein the one or more actions includes an action that specifies usage of a medical device.
Attention is drawn to the Ellis reference, which teaches wherein the one or more actions includes an action that specifies a physical activity and a suggested duration of the physical activity (¶[0334]);
wherein the one or more actions includes an action that specifies an amount of water to consume (¶[0064], ¶[0382]);
wherein the one or more actions includes an action that specifies an amount of a medication to consume (¶¶[0400-0401]); and
wherein the one or more actions includes an action that specifies usage of a medical device (¶[0400]).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the mobile monitoring device of Farringdon as modified to include additional recommendations to the user, as taught by Ellis, to improve the convenience of user activities (Ellis ¶[0003]).
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