Prosecution Insights
Last updated: October 25, 2026
Application No. 18/029,638

METHODS FOR DETERMINING OVULATION TIME

Final Rejection §101§112
Filed
Mar 30, 2023
Priority
Oct 07, 2020 — provisional 63/088,823 +1 more
Examiner
LOPEZ, SEVERO ANTON P
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Medical Research & Development Fund For Health Services Bnai Zion Medical Center
OA Round
4 (Final)
35%
Grant Probability
At Risk
5-6
OA Rounds
1m
Est. Remaining
75%
With Interview

Examiner Intelligence

Grants only 35% of cases
35%
Career Allowance Rate
59 granted / 169 resolved
-35.1% vs TC avg
Strong +40% interview lift
Without
With
+40.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
58 currently pending
Career history
260
Total Applications
across all art units

Statute-Specific Performance

§101
15.0%
-25.0% vs TC avg
§103
43.9%
+3.9% vs TC avg
§102
18.5%
-21.5% vs TC avg
§112
18.6%
-21.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 169 resolved cases

Office Action

§101 §112
DETAILED ACTION This action is responsive to the “RESPONSE TO NON-FINAL OFFICE ACTION” filed 16 August 2026. The Examiner acknowledges the amendments to claims 49, 56-57 62-63, 65-66, and 68. Claims 49-51, 53-58, and 62-68 are pending. 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 . Claim Interpretation Examiner Notes: currently, NO limitation invokes interpretation under § 112(f). Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claim(s) 63 and those dependent therefrom is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 63 recites the limitation “determine, over and between portions of the time period, one or more changes in values of the normalized daily number of steps and/or the normalized daily rate of steps and/or one or more intraday values or trends derived therefrom” [two instances, lines 13-15 and 20-22], wherein the first instance of the limitation is considered to be indefinite, as the recitations of “the normalized daily number of steps” and “the normalized daily rate of steps” lack antecedent basis, as this step [lines 13-15] is considered to occur prior to the processor function to “normalize the daily number of steps and the daily rate of steps…” [lines 17-19]. The second instance of the cited limitation is further considered unclear, as it is not clear whether the second instance is meant to be an additional determination step of the same parameters or not. For examination purposes, the Examiner has interpreted the first instance [lines 13-15] to be omitted, and only the second instance [lines 20-22] to be present [similar to the order of steps in claim 49]. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claim(s) 49-51, 53-58, and 62-68 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Each claim has been analyzed to determine whether it is directed to any judicial exceptions. Representative claim(s) 63 [representing all independent claims] recite(s): A wearable device for determining or predicting ovulation time in a human subject, the device comprising: a sensor configured to measure activity of the subject, during waking hours, over a time period of about 7-45 days time, said activity comprising steps taken by the subject, wherein the sensor is configured to measure the steps during a plurality of interim time points within each day of the time period, each said interim time point being about 1-120 minutes in length; a processing unit comprised within the wearable device and configured to operate in conjunction with the sensor to: determine, from the steps measured during said plurality of interim time points, a daily number of steps and a daily rate of steps for each day of the time period; determine, over and between portions of the time period, one or more changes in values of the normalized daily number of steps and/or the normalized daily rate of steps and/or one or more intraday values or trends derived therefrom; and normalize the daily number of steps and the daily rate of steps relative to a personalized baseline of the subject determined from baseline measurements of the subject, and set a threshold from the normalized values; determine, over and between portions of the time period, one or more changes in values of the normalized daily number of steps and/or the normalized daily rate of steps and/or one or more intraday values or trends derived therefrom; and determine ovulation timing based on changes in as a peak in the normalized daily number of steps, the normalized daily rate of steps, or both, that exceeds said threshold, during at least one of said portions of the time period; and an alert unit of the wearable device configured to issue a tactile, audible or visual indication to the subject at a predetermined time period prior to the determined ovulation timing. (Emphasis added: abstract idea, additional element) Step 2A Prong 1 Representative claim(s) 63 recites the following abstract ideas, which may be performed in the mind or by hand with the assistance of pen and paper: “determine, from the steps measured during said plurality of interim time points, a daily number of steps and a daily rate of steps for each day of the time period” – may be performed by merely observing known or previously collected data and drawing mental conclusions therefrom, for at least a limited amount of data under no particular time constraints “determine, over and between portions of the time period, one or more changes in values of the normalized daily number of steps and/or the normalized daily rate of steps and/or one or more intraday values or trends derived therefrom” – may be performed by merely observing known or previously collected data and drawing mental conclusions therefrom using known or derived mathematical formulas for determining changes or trends in values, for at least a limited amount of data under no particular time constraints [Applicant’s Specification p. 12:22-32] “normalize the daily number of steps and the daily rate of steps relative to a personalized baseline of the subject determined from baseline measurements of the subject, and set a threshold from the normalized values” – may be performed by applying known or derived mathematical formulas or processes to at least a limited amount of known or previously collected data and drawing mental conclusions therefrom [Applicant’s Specification p. 10:4-19] “determine, over and between portions of the time period, one or more changes in values of the normalized daily number of steps and/or the normalized daily rate of steps and/or one or more intraday values or trends derived therefrom” – may be performed by merely observing known or previously collected data and drawing mental conclusions therefrom, for at least a limited amount of data under no particular time constraints [Applicant’s Specification p. 12:22-32] “determine ovulation timing based on changes in as a peak in the normalized daily number of steps, the normalized daily rate of steps, or both, that exceeds said threshold, during at least one of said portions of the time period” – may be performed by merely observing known or previously collected data and drawing mental conclusions therefrom, for at least a limited amount of data under no particular time constraints If a claim, under BRI, covers performance of the limitations in the mind but for the mere recitation of extra-solutionary activity (and otherwise generic computer elements) then the claim falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Step 2A Prong 1 of the Mayo framework as set forth in the 2019 PEG. No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice. Alternatively or additionally, these steps describe the concept of using implicit mathematical formula(s) [i.e., “normalize the daily number of steps and the daily rate of steps relative to a personalized baseline of the subject determined from baseline measurements of the subject, and set a threshold from the normalized values” (Applicant’s Specification p. 10:4-19, statistics, mathematical transformations); “determine, over and between portions of the time period, one or more changes in values of the normalized daily number of steps and/or the normalized daily rate of steps and/or one or more intraday values or trends derived therefrom” (Applicant’s Specification p. 12:22-32, determining a difference in values)] to derive a conclusion based on input of data, which corresponds to concepts identified as abstract ideas by the courts [Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)]. The concept of the recited limitations identified as mathematical concepts above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas. The dependent claims merely include limitations that either further define the abstract idea [e.g. limitations relating to the data gathered or particular steps which are entirely embodied in the mental process] and amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they are merely incidental or token additions to the claims that do not alter or affect how the process steps are performed. Thus, these concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data [Int. Ventures v. Cap One Financial], collecting information, analyzing it, and displaying certain results of the collection and analysis [Electric Power Group], collection, storage, and recognition of data [Smart Systems Innovations]. Step 2A Prong 2 The judicial exception is not integrated into a practical application. Representative claim 63 only recites additional elements of extra-solutionary activity – in particular, extra-solution activity [generic computer function, pre-solution data gathering as a necessary precursor for mental analyses steps] – without further sufficient detail that would tie the abstract portions of the claim into a specific practical application (2019 PEG p. 55 – the instant claim, for example does not tie into a particular machine, a sufficiently particular form of data or signal collection – via the claimed extra-solution activity, or a sufficiently particular form of display or computing architecture/structure). Dependent claim(s) 50-51, 53-56, 58, and 64-66 merely add detail to the abstract portions of the claim but do not otherwise encompass any additional elements which tie the claim(s) into a particular application/integration [the dependent claim(s) recite generic ‘units’ or ‘steps’ which encompass mere computer instructions to carry out an otherwise wholly abstract idea]. Dependent claim(s) 57, 62, and 67-68 encounter substantially the same issues as the independent claim(s) from which they depend in that they encompass further generic extra-solutionary activity [generic data gathering] and/or generic computer elements [storage, memory per se]. Accordingly, the claim(s) are not integrated into a practical application under Step 2A Prong 2. Step 2B The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Independent claims 49 and 63 as individual wholes fail to amount to significantly more than the judicial exception at Step 2B. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of extra-solutionary activity [i.e., generic computer function, data gathering] and generic computer elements cannot amount to significantly more than an abstract idea [MPEP § 2106.05(f)] and is further considered to merely implement an abstract idea on a generic computer [MPEP § 2106.05(d)(II) establishes computer-based elements which are considered to be well understood, routine, and conventional when recited at a high level of generality]. For the independent claim portions and dependent claims which provide additional elements of extra-solutionary data gathering, MPEP § 2106.05(g) establishes that mere data gathering for determining a result does not amount to significantly more. The extra-solutionary activity of processor steps [acquiring, outputting signals, etc.] as presently recited, cannot provide an inventive concept which amounts to significantly more than the recited abstract idea. For the independent claims as well as the dependent claims merely reciting generic computer elements and functions [processing unit and alert unit, each recited at a high level of generality and functions recited therein], MPEP § 2106.05(d)(II) establishes computer-based elements which are considered to be well understood, routine, and conventional when recited at a high level of generality. Accordingly, the generic processing unit and corresponding functions, as presently limited, cannot provide an inventive concept since they fall under a generic structure and/or function that does not add a meaningful additional feature to the judicial exception(s) of the claim(s). Claim 49 recites “measuring, using a wearable device, worn by the subject, during waking hours of the subject over a time period of about 7-45 days, activity of the subject, said activity comprising steps taken by the subject, wherein the steps are measured during a plurality of interim time points within each day of the time period, each said interim time point being about 1-120 minutes in length”, wherein claim 50 further limits the measured activity of the subject as further comprising “body movement, amount of movement, intensity of movement, length of movement, rate of movement, velocity of movement, repetition of movement, posture changes, or any combination thereof”; and wherein claim 63 recites “A wearable device… comprising: a sensor configured to measure activity of the subject, during waking hours, over a time period of about 7-45 days time, said activity comprising steps taken by the subject, wherein the sensor is configured to measure the steps during a plurality of interim time points within each day of the time period, each said interim time point being about 1-120 minutes in length”, wherein claim 64 depends from claim 63 and further limits the measured activity of the subject similar to claim 50. Such a “wearable device” / “sensor” is considered well-understood, routine, and conventional, as known by at least: Applicant’s disclosure is not particular regarding the particular structure of the generically claimed “wearable device” / “sensor” , and recites the wearable device/sensor at a high level of generality [the wearable device may include a smart watch, a smart phone, a step counter, and the like. In some embodiments, the device may include one or more of: suitable sensor(s) (such as, step counter, thermometer, pulse sensor, movement sensor, accelerometer, gyroscope, pulse oximeter, SpO2 sensor, stress sensor, pressure sensor, light sensor, and the like, or any combination thereof), processing unit, memory, display, speaker, a communication unit, power source, a user interface, and the like, or any combination thereof (Applicant’s Specification p. 14:5-11); The apparatuses may be specially constructed for the desired purposes or may include a general-purpose computer(s) selectively activated or reconfigured by a computer program stored in the computer. Such a computer program may be stored in a computer readable storage medium, such as, but not limited to, any type of disk including floppy disks, optical disks, CD-ROMs, magnetic-optical disks, read-only memories (ROMs), random access memories (RAMs), electrically programmable read-only memories (EPROMs), electrically erasable and programmable read only memories (EEPROMs), magnetic or optical cards, or any other type of media suitable for storing electronic instructions, and capable of being coupled to a computer system bus. The processes and displays presented are not inherently related to any particular computer or other apparatus. Various general-purpose systems may be used with programs in accordance with the teachings herein (Applicant’s Specification p. 17:21-31)]. This lack of disclosure is acceptable under 35 U.S.C. 112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the medical technology arts. Thus, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the subject monitoring. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional element because it describes such an additional element in a manner that indicates that the additional element is sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a) [see Berkheimer memo from April 19, 2018, Page 3, (III)(A)(1), not attached]. Adding hardware that performs “well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible [TLI Communications]. Claim 67 recites “one or more sensors for measuring one or more physiological parameters of the subject, said sensors are selected from: stress sensor, accelerometer, gyroscope, heart rate sensor, temperature sensor, SpO2 sensor, respiration sensor, or any combination thereof”. Such a “sensor… for measuring one or more physiological parameters of the subject” is considered well-understood, routine, and conventional, as known by at least: Applicant’s disclosure is not particular regarding the particular structure of the generically claimed “sensor”, and recites the sensor at a high level of generality [the wearable device may include a smart watch, a smart phone, a step counter, and the like. In some embodiments, the device may include one or more of: suitable sensor(s) (such as, step counter, thermometer, pulse sensor, movement sensor, accelerometer, gyroscope, pulse oximeter, SpO2 sensor, stress sensor, pressure sensor, light sensor, and the like, or any combination thereof), processing unit, memory, display, speaker, a communication unit, power source, a user interface, and the like, or any combination thereof (Applicant’s Specification p. 14:5-11)]. This lack of disclosure is acceptable under 35 U.S.C. 112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the medical technology arts. Thus, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the field of subject monitoring. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional element because it describes such an additional element in a manner that indicates that the additional element is sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a) [see Berkheimer memo from April 19, 2018, Page 3, (III)(A)(1), not attached]. Adding hardware that performs “well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible [TLI Communications]. Arikka (US-5851193-A) [Ambulatory measurement of motion has been performed so that an accelerometer (also called an actometer in this field of application) has been attached to man's limb. A conventional single plane or uniaxial motion transducer has been used as the accelerometer, which registers the motion with varying sensitivity depending on the direction of the motion (Arikka Col 1:28-34)] Examiner’s Note Regarding Particular Treatment or Prophylaxis: Claim(s) 62 and 68 recite subject matter regarding “alerting the subject when ovulation time is occurring or is expected” [claim 62] and “an alert unit configured to issue indication regarding ovulation occurrence” [claim 68], which the Examiner notes is not considered to be a particular treatment or prophylaxis, as none of the identified claims positively recite or include language that is considered to be a particular treatment or prophylaxis as an additional element to integrate the judicial exception into a practical application or allow the identified claims to amount to significantly more than the judicial exception [MPEP § 2106.04(d)(2)]. Accordingly, the claim(s) as whole(s) fail amount to significantly more than the judicial exception under Step 2B. Subject Matter Not Taught By Prior Art The closest prior art of record is Kahn (US-20130072765-A1, previously presented) and Brandao (US-20180325382-A1, previously presented) [see p. 11-14 and 17-20 of the Non-Final Rejection dated 3 June 2026 regarding subject matter considered to be taught by Kahn and Brandao with respect to at least claims 49 and 63, not presently reproduced. However, the Examiner notes that each of Kahn and Brandao fails to explicitly disclose, teach, or suggest, alone or in combination, the subject matter regarding the steps to “normalize the daily number of steps and the daily rate of steps relative to a personalized baseline of the subject determined from baseline measurements of the subject, and set a threshold from the normalized values”, “determine, over and between portions of the time period, one or more changes in values of the normalized daily number of steps and the normalized daily rate of steps and/or one or more intraday values or trends derived therefrom” and wherein the determination of ovulation timing comprises “a peak in the normalized daily number of steps, the normalized daily rate of steps, or both, that exceeds said threshold, during at least one of said portions of the time period”. While Kahn discloses applying statistical analyses to measured step count data [Kahn ¶0045], Kahn does not explicitly disclose normalizing the daily number of steps and the daily rate of steps relative to a personalized baseline of the subject determined from baseline measurements of the subject. The Examiner further notes that while Kahn was not specifically previously relied upon to disclose, teach, or suggest determining ovulation using step count measurements or derivatives thereof, Kahn does disclose determining ovulation timing using body temperature data and sleep pattern data [Kahn ¶0039] instead of step count measurements or derivatives thereof. Furthermore, Brandao fails to sufficiently remedy the deficiencies as noted in Kahn, as while Brandao generally discloses daily step count and/or daily rate of steps to determine ovulation timing in animals [specifically cows] based on changes in values of the daily number of steps and/or daily rate of steps, and further generally notes application of the disclosed method to humans without clearly indicating how certain methods may be specifically applied to humans [Brandao ¶¶0053, 0101, 0105-0108], Brandao fails to explicitly disclose, teach, or suggest performing a normalization on measured daily step count or daily step rate relative to a personalized baseline, wherein the determination of ovulation is based on a peak in the normalized daily number of steps, the normalized daily rate of steps, or both, that exceeds said threshold during at least one of said portions of the time period. As such, it would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified any of Kahn or Brandao, alone or in combination, to employ the limitations identified as not being taught by Kahn or Brandao without the benefit of hindsight. Claims 49, 63, and those dependent therefrom are not taught by any prior art reference. Response to Arguments Applicant’s arguments, see Applicant’s Remarks p. 7-8, filed 16 August 2026, with respect to the previously presented claim objections have been fully considered and are persuasive. The objections to claims 56-57, 63, and 65-66 have been withdrawn. Applicant's arguments, see Applicant’s Remarks p. 8-10, with respect to the previously applied rejections under § 101 have been fully considered but they are not persuasive. The Applicant asserts that claims 49 and 63 have been amended to recite steps [see functionality performed by processing unit (see at least lines 10-21 in claim 49)] as a technological solution to a measurement-accuracy problem in existing non-invasive ovulation detection methods and methods of performing an accurate determination, as presented in the Applicant’s Specification. The Applicant further notes that the claims require issuing a tactile, audible, or visual alert to the subject, such that in combination with the steps considered to embody the Applicant’s asserted improvement define a claim that does not merely say “apply it” on a generic computer and is instead a specific, sensor-derived, temporally structured detection technique that improves the accuracy of non-invasive ovulation determination. However, the Examiner disagrees that the argued improvement is considered to improve other technology or technical field, as the Examiner notes that the argued improvement [steps performed by the processing unit in claims 49 and 63] have been identified as being abstract ideas implemented on a generic computer with additional elements that are considered to be well-understood, routine, and conventional. As such, under MPEP 2106.05(a), "an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology". Specifically, the "improvements" analysis in Step 2A determines whether the claim pertains to an improvement to the functioning of a computer or to another technology without reference to what is well-understood, routine, conventional activity [MPEP § 2106.04(d)(1)]. It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception [MPEP § 2106.05(a)]. It is important to note that in order for a method claim to improve computer functionality, the broadest reasonable interpretation of the claim must be limited to computer implementation. That is, a claim whose entire scope can be performed mentally, cannot be said to improve computer technology. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 120 USPQ2d 1473 (Fed. Cir. 2016) (a method of translating a logic circuit into a hardware component description of a logic circuit was found to be ineligible because the method did not employ a computer and a skilled artisan could perform all the steps mentally) [MPEP § 2106.05(a)(I)]. As such, the claims do not recite additional elements that may integrate the abstract ideas into a practical application of the abstract ideas, and thus the claimed invention is not considered to improve other technology or technical field. The Applicant further asserts that the claims satisfy the “particular machine” consideration under MPEP § 2106.05(b), as claim 63 recites a wearable device comprising a sensor, a processing unit comprised within the wearable device, and an alert unit of the wearable device, which defines an integrated particular machine that is not a general-purpose computer [claim 49 recites similar subject matter mutatis mutandis]. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that the limitations directed towards the argued “particular machine” fail to sufficiently limit the wearable device to define the wearable device beyond a well-understood, routine, and conventional wearable computer [processing unit and alert unit each recited at a high level of generality and corresponding functions therein]. It is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir. 2014). See also TLI Communications LLC v. AV Automotive LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (mere recitation of concrete or tangible components is not an inventive concept); Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (noting that Alappat’s rationale that an otherwise ineligible algorithm or software could be made patent-eligible by merely adding a generic computer to the claim was superseded by the Supreme Court’s Bilski and Alice Corp. decisions). The Applicant also asserts that the Examiner’s Step 2A Prong 2 reasoning is under-inclusive because it treats the sensor and processing unit as the only additional elements and dismisses them as merely limiting the type of data or when the data may have been collected [Non-Final Rejection dated 3 June 2026, p. 9], but the amended claims now specify a particular intraday sampling architecture, a particular transformation of that data against a subject-specific baseline, a threshold derived from the normalized values, and a device-executed alert timed relative to the determined event; wherein the Applicant cites MPEP § 2106.05(a) regarding the evaluation of the claim as an ordered combination and avoiding oversimplification of claims, such that the claims as evaluated as an ordered combination plainly integrate any alleged exception into a practical application. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that Step 2A Prong 2 asks “does the claim recite additional elements that integrate the judicial exception into a practical application” [MPEP § 2106.04(II)(A)]. As such, the argued limitations directed towards “a particular transformation of that data against a subject-specific baseline, a threshold derived from the normalized values”, which have been identified as being directed towards mental processes, are not considered to be additional elements. The “particular intraday sampling architecture” has been analyzed at Step 2A Prong 2 as being directed towards pre-solution data gathering as a necessary precursor for the mental analyses, wherein the “particularity” of the intraday sampling is merely considered to limit when the data gathering is performed, and the ”device-executed alert timed relative to the determined event” has been identified as being directed towards generic computer hardware and functionality [display or speaker for outputting signals], such that each limitation is considered to be extra-solution activity in spite of the argued “ordered combination”. The Applicant asserts that the Examiner’s Berkheimer showing at Step 2B is directed exclusively to the wristband hardware and physiological sensors, relying on the Specification’s description of generic sensor types [Applicant’s Specification p. 14:5-11; Non-Final Rejection dated 3 June 2026, p. 6-7]; however, the Applicant asserts that this evidence does not reach the recited normalization-to-a-personalized-baseline step, the threshold-setting step, the peak-detection step, or the timed-alert step, wherein the Applicant asserts that the ordered combination of the argued steps has not been established as being well-understood, routine, and conventional in the field of human ovulation determination. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that “Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception? Examiners should answer this question by first identifying whether there are any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s), and then evaluating those additional elements individually and in combination to determine whether they contribute an inventive concept (i.e., amount to significantly more than the judicial exception(s))” [MPEP § 2106.05(II)]. As the argued “normalization-to-a-personalized-baseline step, the threshold-setting step, the peak-detection step” are considered to recite mental processes/the concept of using implicit mathematical formula(s), the argued steps are not considered in the Step 2B analysis as an additional element that may allow the claim(s) as a whole to amount to significantly more. With respect to “the timed-alert step”, the Examiner notes that the argued step has been analyzed at Step 2B to merely refer to a generic function of outputting a signal via a generic computer element [display, speaker]. Applicant’s arguments, see Applicant’s Remarks p. 11-14, with respect to the previously applied rejections under § 103 have been fully considered and are persuasive. The rejections of claims 49, 63, and those dependent therefrom under § 103 have been withdrawn. 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 SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 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, Charles Marmor II can be reached at (571) 272-4730. 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. /SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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Prosecution Timeline

Show 2 earlier events
Jul 25, 2025
Non-Final Rejection mailed — §101, §112
Oct 26, 2025
Response Filed
Jan 22, 2026
Final Rejection mailed — §101, §112
Apr 18, 2026
Request for Continued Examination
Apr 22, 2026
Response after Non-Final Action
Jun 03, 2026
Non-Final Rejection mailed — §101, §112
Aug 16, 2026
Response Filed
Oct 13, 2026
Final Rejection mailed — §101, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12728198
MEDICAL DEVICE AND METHODS FOR ASSEMBLING AND DISASSEMBLING THE SAME
7y 2m to grant Granted Sep 08, 2026
Patent 12728238
GUIDE WIRE
3y 3m to grant Granted Sep 08, 2026
Patent 12667345
CORE NEEDLE BIOPSY DEVICE FOR COLLECTING MULTIPLE SAMPLES IN A SINGLE INSERTION
4y 2m to grant Granted Jun 30, 2026
Patent 12661041
Cap With Venting Plug for Biological Fluid Collection Device
5y 8m to grant Granted Jun 23, 2026
Patent 12575781
PORTABLE AND WEARABLE ELECTROMYOGRAPHIC BIOFEEDBACK FOR SPINAL CORD INJURY TO ENHANCE NEUROPLASTICITY
6y 5m to grant Granted Mar 17, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

Strategy Recommendation AI-generated — please review before filing

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Prosecution Projections

5-6
Expected OA Rounds
35%
Grant Probability
75%
With Interview (+40.2%)
3y 8m (~1m remaining)
Median Time to Grant
High
PTA Risk
Based on 169 resolved cases by this examiner. Grant probability derived from career allowance rate.

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