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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 12/22/2025 is acknowledged. The arguments have been found persuasive and Group II will be examined with Group I. The restriction of Group II still stand and claim 33 has been withdrawn.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 8, 11, 12, 15, 18, 20, 21, 25, 26, 28 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al. (2016/0038093) in view of McNamara et al. (2010/0268103).
Regarding Claims 1, 8, 15, 18 and 25, Sharma discloses acquiring at least two vital sign parameters such as a fluid index, heart rate, heart rate variability, activity, etc. (see Fig. 7) wherein the heart rate, HR variability, etc. can be detected from electrical activity of the heart (electrocardiograms, see par. [0037, 0038, 0040, 0085]). Sharma also discloses acquiring information of atrial fibrillation events (see AF duration, AF+RVR in Fig. 7) and discloses displaying this information in a comprehensive view such that trend graphs of each vital sign parameter and AF metrics can be simultaneously displayed (Fig. 7). Sharma additionally discloses that AF burden can be a metric that s tracked and displayed (par. [0076, 0085, 0133]) but does not show a specific example in the drawings of simultaneously displaying the AF burden with the other parameters. Sharma also discloses that specific time windows can be set by a user for analysis (par. [0107, 0116, 0127]) but again fails to disclose any specific example in which AF burden is analyzed with the vital sign parameter trends and AF event trends.
However, McNamara, in the same field of endeavor of cardiac health reporting, discloses creating AF burden trend charts that are aligned with vital sign data such as heart rate trends (Fig. 3) for the purpose of providing a more detailed snapshot of patient health surrounding atrial fibrillation events, thus aiding a clinician in the monitoring and treatment of the patient (par. [0038-0040, 0049, 0051, 0058]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Sharma reference to include displaying AF burden trends with other vital sign parameter trends such as heart rate, as taught and suggested by McNamara, for the purpose of providing a more detailed snapshot of patient health surrounding atrial fibrillation events, thus aiding a clinician in the monitoring and treatment of the patient.
The combination of Sharma and McNamara (the addition of AF burden trends to the metric data being displayed) would result in a simultaneous display of vital sign parameter trends; AF event trends; and AF burden trends on a single display with a common timeline that can be analyzed over user selected time periods to assess cardiac health.
Claims 2 and 26 define intended results of what the simultaneous display of parameters can provide visually. The Examiner notes the Sharma and McNamara references disclose the combined display of data trends of all of the claimed parameters over a common timeline. The display of these trends would then provide visual similarities, difference, correlations, effects, etc. as a natural result of their display.
In regard to Claim 3, Sharma discloses providing markers (peaks, see 154, 156 in Fig. 7) when AF occurs verses a time of no marks or peaks indicative of when no AF event occurs (Fig. 7).
With regard to Claim 4, Sharma and McNamara discloses marking a dot 322 in the HR signal when an AF event is detected (McNamara, Fig. 3, par. [0036]).
Regarding Claim 5, the graphed data of Sharma clearly shows various extrema (max and min values) over time. Sharma also discloses presenting max values such as max fluid values or max contraction rates over a specified time range (par. [0113, 0119]; Fig. 6, 7).
In regard to Claim 6, the trend graphs of Sharma and McNamara using a common time scale would provide visual indications of extrema associated with AF events and extreme not associated with AF events. One could see a peak in a vital signa trend that does not align with an AF event as well as peaks that do align with AF events (see Fig. 7). Sharma also discloses that various markers, colors, etc. can be used to highlight critical values (par. [0126]).
In regard to Claims 11 and 12, Sharma and McNamara disclose providing statistical information for atrial fibrillation, such as proportion of time over a time period a user spent in Afib (McNamara, par. [0039]; Fig. 3).
Regarding Claims 20, 21 and 31, Sharma discloses the various displayed parameters can be a result of user selection of “hotkeys” such as menus, scroll bars, navigation buttons, etc. (the claimed “click operation of a user”, see par. [0044, 0047, 0099, 0115]) and alarm conditions can be displayed (see mark 140 in Fig. 6; par. [0126]).
Regarding Claim 28, Sharma discloses providing markers (peaks, see 154, 156 in Fig. 7) when AF occurs verses a time of no marks or peaks indicative of when no AF event occurs (Fig. 7). Additionally, the graphed data of Sharma clearly shows various extrema (max and min values) over time. Sharma also discloses presenting max values such as max fluid values or max contraction rates over a specified time range (par. [0113, 0119]; Fig. 6, 7). Sharma further discloses the various displayed parameters can be a result of user selection of “hotkeys” such as menus, scroll bars, navigation buttons, etc. (the claimed “click operation of a user”, see par. [0044, 0047, 0099, 0115]) and alarm conditions can be displayed (see mark 140 in Fig. 6; par. [0126]).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma et al. (2016/0038093) in view of McNamara et al. (2010/0268103), further in view of Huang et al. (2014/0067838).
Regarding Claim 9, Sharma discloses including trend data such as blood pressure trend data (par. [0126]) but fails to disclose systolic and diastolic trends having a shared vertical coordinate. However, Huang discloses displaying both diastolic and systolic pressure with heart rate trends (Fig. 5) for the purpose of providing a more complete health picture over time rather than just based on current health information (par. [0003-0010]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Sharma and McNamara combination to include displaying both diastolic and systolic pressure with heart rate trends, as taught and suggested by Huang, for the purpose of providing a more complete health picture over time rather than just based on current health information. The example of Fig. 5 of Huang discloses vertical axes that have a common measurement (mmHg) so in one interpretation, that could be considered a common vertical coordinate. Huang does not disclose, in this example, a common magnitude scale for the mmHg measures. However, Huang, in another embodiment discloses that the diastolic and systolic measures can be plotted on the same coordinate system having the same values of magnitude on the vertical axis, (see Fig. 4a, b). It would have been an obvious matter of design choice to establish a common magnitude of values for a vertical axis in displaying systolic and diastolic pressure in that in either configuration (a common set of values or a lack of a common set of values) would equally provide accurate readings of systolic and diastolic pressure. Scaling a figure or not scaling a figure would not have any bearing on the values displayed.
In regard to Claim 10, Sharma discloses displaying different colors based on the values of the detected parameters (par. [0126]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLEN PORTER whose telephone number is (571)270-5419. The examiner can normally be reached Mon - Fri 9:00-6:00 EST.
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, Carl Layno can be reached at 571-272-4949. 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.
/ALLEN PORTER/Primary Examiner, Art Unit 3796