DETAILED ACTION
This Office Action is in response to the communication dated 24 November 2025 concerning Application No. 18/463,096 filed on 07 September 2023.
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 .
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 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.
Status of Claims
Claims 1-20 are pending and currently under consideration for patentability; claims 1, 6, 15, and 18 have been amended; claims 21-60 previously were canceled.
Response to Arguments
Applicant’s arguments filed 24 November 2025 have been fully considered, but they are not persuasive.
Applicant has amended the independent claims to further recite calculating an ensemble of estimated cycle times, each of which is dependent on a particular metric, calculating the probability of accurately estimating cycle times, and using this probability to calculate a cycle time within the hormonal cycle. The Examiner has addressed the amended limitations in the updated text of the rejection below.
Applicant argues that “none of the cited art suggests any corresponding use of physiological metric ensembles to improve evaluation of menstrual cycle timing” (Arguments, p. 7). In support of this, Applicant merely argues that Koch’s teachings, in particular paragraph [0091], are different than the claimed limitations. For example, Applicant argues that Koch’s description of analytically determining how physiological parameters are related to the day of ovulation is different than calculating a cycle time within the hormonal cycle based on a combination of ensemble estimated cycle times and the probability of accurately estimating the cycle time. The Examiner respectfully disagrees and directs Applicant to the cited paragraphs in the updated text of the rejection below. In particular, the Examiner respectfully submits that Koch’s description of calculating cycle phase probabilities based on the probability that a female is in a particular cycle phase ([0059]) is analogous to calculating a cycle time within the hormonal cycle as claimed. Similarly, the Examiner respectfully maintains that determining the time interval of using contraception, which is related to the menstrual cycle of the female, is analogous to calculating or estimating a cycle time. Therefore, the Examiner respectfully maintains that Koch describes the limitations recited by the pending claims.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5-8, 10, and 12-20 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Koch et al. (EP 3785641 A1).
Regarding claims 1, 6, and 18, Koch describes a system, method, and computer program product comprising computer executable code embodied in a non-transitory computer readable medium that, when executing on one or more computing devices ([0009]), performs the steps of
providing a model ([0014]) that characterizes timewise changes during a model hormonal cycle for each of a heart rate variability, a resting heart rate, a body temperature, and a respiration rate ([0012])
acquiring physiological data for a user from a wearable monitor ([0039]), wherein the physiological data includes at least heart rate data and body temperature data ([0040]), and wherein the physiological data is acquired during a hormonal cycle for the user ([0011])
calculating a number of metrics for the user at least daily during the hormonal cycle, the number of metrics including at least the heart rate variability, the resting heart rate, the body temperature, and the respiration rate ([0056])
calculating an ensemble of estimated cycle time for the user relative to the model hormonal cycle, wherein each estimated cycle time in the ensemble of estimated cycle times is based on one of the number of metrics independently ([0059], [0061], sequences of sets of probabilities, each corresponding to a particular interval of time and to one of set of cycle phases of the menstrual cycle)
calculating a probability of accurately estimating a metric-dependent cycle time for each of the number of metrics ([0059], [0079])
calculating a cycle time within the hormonal cycle for the user based on a combination of the ensemble of the estimated cycle times and the probability of accurately estimating the metric-dependent cycle time for each of the number of metrics ([0059], [0063], [0079])
providing coaching information to the user based on the cycle time ([0069])
Regarding claims 2 and 7, Koch describes wherein the hormonal cycle includes a menstrual cycle for the user ([0011]).
Regarding claims 3 and 8, Koch describes wherein the hormonal cycle includes a pregnancy of the user ([0065]).
Regarding claims 5 and 10, Koch describes wherein the ensemble includes a combination of the estimated cycle time for each of the number of metrics based on a probability of accurately estimating the cycle time ([0079]).
Regarding claim 12, Koch describes wherein the ensemble includes an average of at least two of the estimated cycle times ([0059]).
Regarding claim 13, Koch describes wherein the wearable monitor includes a photoplethysmography monitor ([0041]).
Regarding claim 14, Koch describes wherein the two or more physiological metrics include at least one of a heart rate variability, a resting heart rate, and a respiration rate ([0012]).
Regarding claim 15, Koch describes wherein the two or more physiological metrics include a body temperature ([0040]), the wearable monitor includes a temperature sensor ([0040]), the method includes acquiring temperature data from the temperature sensor and calculating the body temperature at least daily for the user ([0040], [0056]).
Regarding claim 16, Koch describes wherein the model hormonal cycle is derived from a population of users ([0014]).
Regarding claim 17, Koch describes wherein the model hormonal cycle is derived from a history of the user ([0060]).
Regarding claim 19, Koch describes wherein the processor executes on a personal computing device of the user ([0048]).
Regarding claim 20, Koch describes wherein the processor executes on a remote server coupled to the wearable monitor through a data network ([0038]).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 4, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Koch in view of Pardey et al. (US 2016/0143630 A1).
Regarding claims 4 and 9, Koch describes the computer program product of claim 1 and the method of claim 6, including using weighting parameters and bias parameters within the layers of a neural network through with the physiological data passes ([0075]). However, Koch does not explicitly disclose wherein the ensemble includes a weighted average of the estimated cycle time for each of the number of metrics. Pardey also describes a system for acquiring physiological data from a user and determining a hormonal cycle for the user ([0005]), including using a weighted average of an estimated cycle time for each of a number of metrics ([0352] - [0353]). As Pardey is also directed towards obtaining physiological data for determining a hormonal cycle and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a weighted averaging step similar to that described by Pardey when using the system described by Koch, as doing so advantageously allows for a more accurate determination of the user’s cycle.
Regarding claim 11, Pardey describes wherein the ensemble includes a Bayesian model average of the estimated cycle times ([0302]).
Statement on Communication via Internet
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Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
THIS ACTION IS MADE FINAL. 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 Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM 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 by telephone 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 at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3792