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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 April 2026 has been entered.
The Examiner acknowledges the amendments to claims 49, 53-55, 58, 63, and 65-66, and the cancelation of claims 52 and 59-61. Claims 49-51, 53-58, and 62-68 are pending.
Claim Objections
Claim(s) 56-57, 63, and 65-66 is/are objected to because of the following informalities:
Claim 56 should read “time period [line 4] to maintain consistency with claim 49.
Claim 57 should read “time period [line 3] to maintain consistency with claim 49.
The Examiner notes that claims 63 and 65-66 each recite one or the other of “period of time” [line 4 of claim 63] and “time period” [lines 8, 12 of claim 63; lines 5-6 of claim 65; line 2 of claim 66]. Each instance should only recite one or the other of “period of time” or “time period” to maintain consistency.
Lines 7-12 of claim 63 should be tabbed over to the right to indicate functions of the claimed processing unit.
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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 period of time of about 7-45 days, said activity comprising steps taken by the subject; and
a processing unit configured to operate in conjunction with the sensor to:
determine daily number of steps and/or daily rate of steps from the measured steps;
determine, over and between portions of the time period, one or more changes in values of the daily number of steps and/or daily rate of steps and/or one or more intraday values or trends derived therefrom; and
determine ovulation timing based on changes in the daily number of steps, the daily rate of steps, or both, during at least one of said portions of the time period.
(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 daily number of steps and/or daily rate of steps from the measured steps” – 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 daily number of steps and/or 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
“determine ovulation timing based on changes in the daily number of steps, the daily rate of steps, or both, 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., “determine, over and between portions of the time period, one or more changes in values of the daily number of steps and/or daily rate of steps and/or one or more intraday values or trends derived therefrom”] 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, data gathering] – 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 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, 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 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 period of time of about 7-45 days, said activity comprising steps taken by the subject”, 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)]. 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, previously presented) [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.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 49-51, 53-58, and 62-68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahn (US-20130072765-A1, previously presented) in view of Brandao (US-20180325382-A1).
Regarding claim 49, Kahn teaches
A non-invasive method for determining or predicting ovulation timing in a human subject, the method comprising:
measuring, using a wearable device, 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 [The wristband 310 includes a plurality of sensors 320. The sensors 320 may include one or more of an accelerometer/gyroscope 325 (Kahn ¶0031); In one embodiment, the system further includes step counter logic 355. Step counter logic 355, in one embodiment, uses data from accelerometer/gyroscope 325, and optionally other sensors, to count repetitive motions, such as steps (Kahn ¶0040), wherein measuring steps is considered to be defined as being performed during at least waking hours of the subject; In one embodiment, health analysis system may further utilize the user's temperature data and sleep pattern data to determine a woman's ovulation cycle. Ovulation is correlated with morning temperature variations in women. Therefore, by tracking the woman's body temperature throughout the day, band health analysis system 360 can provide fertility awareness. Fertility awareness is useful for conceiving, avoiding conception, and monitoring gynecological health. The analysis, in one embodiment, is based on long-term analysis of temperature data over multiple months (Kahn ¶0039); the user interface 395 also may provide more complex outputs, for example, a user's steps taken over the day or week, comparison or statistics of activity and/or health data, etc. (Kahn ¶0045), wherein as the method of Kahn is directed towards continuous monitoring during a subject’s menstrual cycle, the time period of Kahn is considered to overlap with the claimed time period of 7-45 days]; and
processing data obtained by the wearable device using a processing unit configured to operate in conjunction with the wearable device [wristband 310 may include a low power processor and a higher power processor. In one embodiment, wristband 310 may include low power sensors and higher power sensors… Power management system 370 determines when to activate and inactivate various sensors 320, or calculation systems, such as step counter 355, health analysis system 360, communication logic 379, and user interface 375 (Kahn ¶0041)] to:
determine daily number of steps and/or rate of steps from the measured steps [Kahn ¶0040; the user interface 395 also may provide more complex outputs, for example, a user's steps taken over the day or week, comparison or statistics of activity and/or health data, etc. (Kahn ¶0045)];
determine, over and between portions of the time period, one or more changes in values of the daily number of steps and the daily rate of steps and/or one or more intraday values or trends derived therefrom [Kahn ¶0045]; and
determine ovulation timing [In one embodiment, health analysis system may further utilize the user's temperature data and sleep pattern data to determine a woman's ovulation cycle. Ovulation is correlated with morning temperature variations in women. Therefore, by tracking the woman's body temperature throughout the day, band health analysis system 360 can provide fertility awareness. Fertility awareness is useful for conceiving, avoiding conception, and monitoring gynecological health. The analysis, in one embodiment, is based on long-term analysis of temperature data over multiple months. In one embodiment, this occurs on the computer system 380, rather than on the band 310 (Kahn ¶0039)].
However, Kahn fails to explicitly disclose wherein the determination of ovulation timing is based on changes in the daily number of steps, the daily rate of steps, or both, during at least one of said portions of the timing period.
Brandao discloses systems and methods for analyzing a menstrual cycle of an animal, wherein Brandao explicitly discloses that the disclosed systems and methods are applicable to a human [The systems, methods and devices set forth herein are not so limited, however, as other forms domesticated and wild mammals may be managed using these techniques, including but not limited to wolves, large cats, deer, bison, goats, elephants, etc. Moreover, it will be immediately apparent that the various techniques disclosed herein can be applied to other forms of animals, including humans (Brandao ¶0053)]. Brandao discloses measuring, using a wearable device, during waking hours of a subject, steps taken by the subject; and analyzing changes in the daily number of steps to determine ovulation timing [FIG. 15 shows a functional block representation of various sensor inputs that can be utilized by the tag assembly 102. A central control circuit 240 may be realized by the aforementioned programmable processor or other circuitry of the tag. Sensors include… a multi-axis (e.g., x, y, z) accelerometer 242 (Brandao ¶0101); The activity waveform 260 represents the output from a selected sensor such as the accelerometer 242 to indicate activity by the cow (in this case, number of steps taken by the animal) (Brandao ¶0105); As can be determined from an examination of FIG. 16, the animal experienced a higher than baseline amount of activity beginning in the night of the first day (02-13) and through the daylight hours of the second day (02-14) (Brandao ¶0107); This enhanced physical activity was interpreted as an indication that the cow was ovulating (Brandao ¶0108)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Kahn to employ wherein the determination of ovulation timing is based on changes in the daily number of steps, the daily rate of steps, or both, during at least one of said portions of the timing period, so as to employ an additional and/or alternative indicator of ovulation timing and as this modification would amount to merely applying a known technique [daily step count analysis to determine ovulation timing] to a known device (method, or product) ready for improvement to yield predictable results [use collected data to determine ovulation timing] [MPEP § 2143(I)(D)].
Regarding claim 50, Kahn in view of Brandao teaches
The method according to claim 49, wherein the measured activity of the subject further comprises 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 [Kahn ¶0040].
Regarding claim 51, Kahn in view of Brandao teaches
The method according to claim 49, wherein the measured steps comprise: total number of steps, daily number of steps, number of steps per time unit, average number of steps, rate of steps, average rate of steps, daily rate of steps, length of steps, average length of steps, normalized values thereof, or any combination thereof [Kahn ¶¶0040, 0045].
Regarding claim 53, Kahn in view of Brandao teaches
The method according to claim 49, wherein the processing unit is configured to determine one or more changes in one or more parameters derived from the values of the daily number of steps and/or the daily rate of steps during one or more portions of the time period [See § 103 modification of claim 49 above; Brandao ¶¶0105, 0107-0108].
Regarding claim 54, Kahn in view of Brandao teaches
The method according to claim 53, wherein the parameters comprise normalized values of said parameters, intraday values of the parameters, trends of said values, or any combination thereof [See § 103 modification of claim 49 above; Brandao ¶¶0105, 0107-0108].
Regarding claim 55, Kahn in view of Brandao teaches
The method according to claim 49, wherein an increase in the measured activity during at least one of said portions of the time period and/or an increase in parameters derived from the measured activity values are indicative of ovulation time [See § 103 modification of claim 49 above; Brandao ¶¶0105, 0107-0108].
Regarding claim 56, Kahn in view of Brandao teaches
The method according to claim 49, wherein an increase in the daily number of steps, daily rate of steps, average number of daily steps, average number of steps and/or rate of steps, and/or in parameters derived therefrom, in an interim period of the period of time, is indicative of ovulation time [Brandao ¶¶0105, 0107-0108].
Regarding claim 57, Kahn in view of Brandao teaches
The method according to claim 49, further comprising measuring one or more physiological parameters of the subject and determining a pattern in the physiological parameters over the period of time [The sensors 320 may include one or more of an accelerometer/gyroscope 325, thermometer(s) 330, barometer 335, blood pressure/heart rate sensor 345, blood oxygen sensor 340, pH sensor to determine acidity/alkalinity of the user's body, and other sensors 350 (Kahn ¶0031)].
Regarding claim 58, Kahn in view of Brandao teaches
The method according to claim 49, wherein the time period is in the length of about 14-28 days [See § 103 modification above; wherein as the modified method of Kahn in view of Brandao is directed towards continuous monitoring during a subject’s menstrual cycle, the time period of Kahn is considered to overlap with the claimed time period of 14-28 days].
Regarding claim 62, Kahn in view of Brandao teaches
The method according to claim 49, further comprising alerting the subject when ovulation time is occurring or is expected [If information should be provided to the user, at block 955 the user is notified of her fertility state. The process then returns to block 915. In one embodiment, cumulative/statistical temperature data may be shared with a central database (Kahn ¶0107)].
Regarding claim 63, Kahn teaches
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 period of time of about 7-45 days, said activity comprising steps taken by the subject [The wristband 310 includes a plurality of sensors 320. The sensors 320 may include one or more of an accelerometer/gyroscope 325 (Kahn ¶0031); In one embodiment, the system further includes step counter logic 355. Step counter logic 355, in one embodiment, uses data from accelerometer/gyroscope 325, and optionally other sensors, to count repetitive motions, such as steps (Kahn ¶0040), wherein measuring steps is considered to be defined as being performed during at least waking hours of the subject; In one embodiment, health analysis system may further utilize the user's temperature data and sleep pattern data to determine a woman's ovulation cycle. Ovulation is correlated with morning temperature variations in women. Therefore, by tracking the woman's body temperature throughout the day, band health analysis system 360 can provide fertility awareness. Fertility awareness is useful for conceiving, avoiding conception, and monitoring gynecological health. The analysis, in one embodiment, is based on long-term analysis of temperature data over multiple months (Kahn ¶0039); the user interface 395 also may provide more complex outputs, for example, a user's steps taken over the day or week, comparison or statistics of activity and/or health data, etc. (Kahn ¶0045), wherein as the method of Kahn is directed towards continuous monitoring during a subject’s menstrual cycle, the time period of Kahn is considered to overlap with the claimed time period of 7-45 days]; and
a processing unit configured to operate in conjunction with the sensor [wristband 310 may include a low power processor and a higher power processor. In one embodiment, wristband 310 may include low power sensors and higher power sensors… Power management system 370 determines when to activate and inactivate various sensors 320, or calculation systems, such as step counter 355, health analysis system 360, communication logic 379, and user interface 375 (Kahn ¶0041)] to:
determine daily number of steps and/or daily rate of steps from the measured steps [Kahn ¶0040; the user interface 395 also may provide more complex outputs, for example, a user's steps taken over the day or week, comparison or statistics of activity and/or health data, etc. (Kahn ¶0045)];
determine, over and between portions of the time period, one or more changes in values of the daily number of steps and/or daily rate of steps and/or one or more intraday values or trends derived therefrom [Kahn ¶0045]; and
determine ovulation timing [In one embodiment, health analysis system may further utilize the user's temperature data and sleep pattern data to determine a woman's ovulation cycle. Ovulation is correlated with morning temperature variations in women. Therefore, by tracking the woman's body temperature throughout the day, band health analysis system 360 can provide fertility awareness. Fertility awareness is useful for conceiving, avoiding conception, and monitoring gynecological health. The analysis, in one embodiment, is based on long-term analysis of temperature data over multiple months. In one embodiment, this occurs on the computer system 380, rather than on the band 310 (Kahn ¶0039)].
However, Kahn fails to explicitly disclose wherein the determination of ovulation timing is based on changes in the daily number of steps, the daily rate of steps, or both, during at least one of said portions of the time period.
Brandao discloses systems and methods for analyzing a menstrual cycle of an animal, wherein Brandao explicitly discloses that the disclosed systems and methods are applicable to a human [The systems, methods and devices set forth herein are not so limited, however, as other forms domesticated and wild mammals may be managed using these techniques, including but not limited to wolves, large cats, deer, bison, goats, elephants, etc. Moreover, it will be immediately apparent that the various techniques disclosed herein can be applied to other forms of animals, including humans (Brandao ¶0053)]. Brandao discloses measuring, using a wearable device, during waking hours of a subject, steps taken by the subject; and analyzing changes in the daily number of steps to determine ovulation timing [FIG. 15 shows a functional block representation of various sensor inputs that can be utilized by the tag assembly 102. A central control circuit 240 may be realized by the aforementioned programmable processor or other circuitry of the tag. Sensors include… a multi-axis (e.g., x, y, z) accelerometer 242 (Brandao ¶0101); The activity waveform 260 represents the output from a selected sensor such as the accelerometer 242 to indicate activity by the cow (in this case, number of steps taken by the animal) (Brandao ¶0105); As can be determined from an examination of FIG. 16, the animal experienced a higher than baseline amount of activity beginning in the night of the first day (02-13) and through the daylight hours of the second day (02-14) (Brandao ¶0107); This enhanced physical activity was interpreted as an indication that the cow was ovulating (Brandao ¶0108)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kahn to employ wherein the determination of ovulation timing is based on changes in the daily number of steps, the daily rate of steps, or both, during at least one of said portions of the time period, so as to employ an additional and/or alternative indicator of ovulation timing and as this modification would amount to merely applying a known technique [daily step count analysis to determine ovulation timing] to a known device (method, or product) ready for improvement to yield predictable results [use collected data to determine ovulation timing] [MPEP § 2143(I)(D)].
Regarding claim 64, Kahn in view of Brandao teaches
The wearable device according to claim 63, wherein the measured activity of the subject further comprises 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 [Kahn ¶0040].
Regarding claim 65, Kahn in view of Brandao teaches
The wearable device according to claim 63, wherein the processing unit is configured to determine one or more changes in one or more parameters derived from the values of the measured activity during one or more interim periods of the period of time; wherein the parameters comprise normalized values of said parameters, intraday values of the parameters, trends of said measured values or any combinations thereof [See § 103 modification of claim 63 above; Brandao ¶¶0105, 0107-0108].
Regarding claim 66, Kahn in view of Brandao teaches
The device according to claim 65, wherein an increase in the value of the measured activity in the one or more interim time periods of the period of time, as determined by the processing unit, and/or increase in parameters derived therefrom is indicative of ovulation time [See § 103 modification of claim 63 above; Brandao ¶¶0105, 0107-0108].
Regarding claim 67, Kahn in view of Brandao teaches
The device according to claim 63, further comprising 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 [Kahn ¶0031].
Regarding claim 68, Kahn in view of Brandao teaches
The device according to claim 63, further comprising an alert unit configured to issue an indication regarding ovulation occurrence [Kahn ¶0107].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 7, filed 18 April 2026, with respect to the previously presented claim objections have been fully considered and are persuasive. The objections to claims 49 and 63 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 7, with respect to the previously applied rejections under § 112(b) have been fully considered and are persuasive. The rejection of claim 66 under § 112(b) has been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 7-9, with respect to the previously applied rejections under § 101 have been fully considered but they are not persuasive.
The Applicant asserts that (A) the amended claims are not directed merely to a mental process, as the Applicant notes that the amendments require acquisition of step data by a wearable device during waking hours over a specifically recited multi-day interval, followed by processor-performed determination of daily metrics and derived intraday values or trends over and between portions of that interval, which the Applicant argues is different from a claim that simply states a desired result or a bare correlation and now recites a particular machine-implemented workflow using specified sensor-derived inputs, specified temporal organization of the data, and specified processor-performed determinations. The Examiner acknowledges the amendments to the claims and notes that in the Step 2A Prong 1 analysis of representative claim 63, the claimed wearable device comprising a sensor and processing unit are noted as being additional elements. However, the Examiner notes that the Step 2A Prong 1 analysis is merely to determine whether a claim recites a judicial exception, which based on the analysis above, claim 63 does recite a judicial exception. The above § 101 analysis at Step 2A Prong 2 and Step 2B, as well as the response to arguments B and C below, acknowledge that the amended claims are not directed merely to a mental process, but that the claimed additional elements fail to integrate the mental process into a practical application at Step 2A Prong 2 and fail to allow the claims as a whole to amount to significantly more at Step 2B.
The Applicant asserts that (B) the amended claims integrate any alleged exception into a practical application, as the Applicant notes that the amended claims require real-world collection of measured step data from a human subject using a wearable device and further require coordinated processing of that data, such that the claims do not merely say “apply it” on a generic computer, but instead recite how ovulation timing is determined. However, the Examiner disagrees with the Applicant’s argument, as the argued limitations directed towards the claimed sensor and processing unit are considered to be directed towards extra-solution activity of data gathering and generic computer elements, as the argued “real-world collection of measured step data from a human subject” is considered to refer to pre-solution activity of gathering data for use in the claimed process/determination performed by a processing unit recited at a high level of generality. The argued limitations regarding the processing unit are considered to be additional elements that merely amount to a recitation of the words “apply it” [or equivalent] to an abstract idea on a computer, as the steps performed by the processing unit have been identified as reciting abstract ideas that may be performed in the mind or by hand, as implemented on a generic computer.
The Applicant asserts that (C) the amended claims amount to significantly more than any alleged exception, as the Applicant notes that the ordered combination of elements of a wearable-device step measurement during waking hours, a defined 7-45 day period, processor determination of daily number/rate of steps, processor determination of changes, and determination of ovulation is a concrete, machine-implemented, temporally structure detection technique for non-invasive ovulation determination. However, the Examiner disagrees with the Applicant’s argument, as the step measurement occurring during waking hours and defined 7-45 day period are considered to merely limit the type of data or when the data may have been collected via extra-solution data gathering at Step 2A Prong 2. Furthermore, the additional elements of a wearable device and processing unit are considered to be well-understood, routine, and conventional at Step 2B, such that the wearable device and processing unit fail to allow the claim as a whole to amount to significantly more.
Applicant’s arguments, see Applicant’s Remarks p. 10-13, with respect to the rejection(s) of claim(s) 49, 63, and those dependent therefrom under § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kahn (US-20130072765-A1, previously presented) in view of Brandao (US-20180325382-A1).
The Applicant asserts that the previously applied Kahn reference uses step counter logic for evaluating workout activity of related user information and thus fails to teach the claimed features of determining ovulation timing from changes in step-based activity metrics over time, as well as measuring steps during waking hours over a time period of about 7-45 days and using a processing unit to perform the ovulation timing determination as claimed. The Applicant asserts that the previously applied Provost reference fails to remedy the argued deficiencies of Kahn and is likewise not relevant to the claimed ovulation determination, as Provost is directed towards motion-capture and behavioral study concerning gait differences across the menstrual cycle. The Applicant asserts that the previously applied Roelofs reference fails to remedy any of the deficiencies of Kahn or Provost, as Roelofs is from a different field and context directed towards estrus detection and prediction of ovulation in dairy cattle, which have a different physiological setting, subject population, purpose, and use environment from the claimed invention. The Applicant further asserts that the previously applied combination of references lack a sufficient reasoned basis and reasonable expectation of success, as the subject matter of Kahn [temperature and sleep pattern data for fertility awareness], Provost [motion-capture analysis of gait differences across the menstrual cycle], and Roelofs [pedometer-based estrus detection in dairy cattle] each point in different directions and thus fail to collectively teach the claimed workflow. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 49/63 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Claims 49/63 are presently rejected as being obvious over Kahn (US-20130072765-A1, previously presented) in view of Brandao (US-20180325382-A1), wherein Brandao discloses analyzing a menstrual cycle of an animal, wherein “animal” is considered to include a human [The systems, methods and devices set forth herein are not so limited, however, as other forms domesticated and wild mammals may be managed using these techniques, including but not limited to wolves, large cats, deer, bison, goats, elephants, etc. Moreover, it will be immediately apparent that the various techniques disclosed herein can be applied to other forms of animals, including humans (Brandao ¶0053)]. Brandao further discloses measuring, using a wearable device, during waking hours of a subject, steps taken by the subject; and analyzing changes in the daily number of steps to determine ovulation timing [FIG. 15 shows a functional block representation of various sensor inputs that can be utilized by the tag assembly 102. A central control circuit 240 may be realized by the aforementioned programmable processor or other circuitry of the tag. Sensors include… a multi-axis (e.g., x, y, z) accelerometer 242 (Brandao ¶0101); The activity waveform 260 represents the output from a selected sensor such as the accelerometer 242 to indicate activity by the cow (in this case, number of steps taken by the animal) (Brandao ¶0105); As can be determined from an examination of FIG. 16, the animal experienced a higher than baseline amount of activity beginning in the night of the first day (02-13) and through the daylight hours of the second day (02-14) (Brandao ¶0107); This enhanced physical activity was interpreted as an indication that the cow was ovulating (Brandao ¶0108)].
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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