DETAILED ACTION
This action is responsive to the claim amendments and Applicant’s Remarks filed 26 October 2025. The Examiner acknowledges the amendments to claims 49-51, 55-56, 60, 63, 66, and 68. Claims 49-68 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 Objections
Claim(s) 49 and 63 is/are objected to because of the following informalities:
Claim 49 should read “said activity comprising steps taken by the subject” [lines 3-4]. Claim 63 is rejected for similar language [lines 3-4] and a similar suggestion is provided mutatis mutandis.
Appropriate correction is required.
Claim Interpretation
Examiner Notes: The claim interpretations under § 112(f) that were previously presented in the Non-Final Rejection dated 25 July 2025 [p. 2-5] are maintained.
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) 66 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 66 recites the limitation “an increase in the value of the measured activity in an interim period of the period of time” [lines 1-2, emphasis applied], which is considered indefinite, as claim 65 recites “one or more changes in values of the measured activity during one or more interim periods of the period of time” [lines 2-3, emphasis applied], such that it is unclear whether the recitation of “an interim period of the period of time” of claim 66 is meant to refer to a different interim period from the “one or more interim periods of the period of time” as recited in claim 65, or refer to the one or more interim periods of the period of time” as recited in claim 65. For examination purposes, the Examiner has interpreted either identified interpretation to be applicable in light of any art applied under § 102 or § 103.
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) 49-68 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, over a period of time, said activity comprise steps taken by the subject; and
a processing unit configured to determine a pattern of the measured activity, over the period of time; wherein the pattern is indicative of ovulation.
(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 a pattern of the measured activity, over the period of time; wherein the pattern is indicative of ovulation” – may be performed by merely observing previously determined or known values/data and drawing mental conclusions therefrom based on known or derived relationships [Applicant’s Specification p. 9:15-20]
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 a pattern of the measured activity, over the period of time”] 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 of generic computer function(s) and 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 generic computer function(s) and data gathering, or a sufficiently particular form of display or computing architecture/structure).
Dependent claim(s) 50-56, 58-59, 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, 60-62, and 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 of acquiring, storing, performing processing steps on signals, or providing an indication [alert, notification, 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 [generic computers and their functions], 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 computer elements and their 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(s) 60-61 recite “a wearable device” for performing measurements. Such a “wearable device” 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”, and recites the wearable device at a high level of generality [the wearable device may include a smart watch, a smart phone, a step counter, and the like (Applicant’s Specification p. 14:5-6)]. 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].
Zhao (US-20160113569-A1, previously presented) [As would be understood by one of skill in the art, the “smart” wearable user devices may include processing systems, memory systems, communication systems, sensor systems, and/or any other devices or systems known in the art that allow those wearable user devices to collect the user health data and communicate it as discussed below. For example, the “smart” glasses 202 may collect audio data, video data (i.e., from the point of view of the first user 200, of the first user 200 via an eye or face facing camera, etc.), user movement (e.g., head movement) data, brainwave data, temperature data, breathing data, and/or any other user data known in the art that is collectable by “smart” glasses. Similarly, the “smart” watch 204 may collect user movement (e.g., arm and hand movement) data, pulse data, temperature data, and/or any other user data known in the art that is collectable by “smart” watches, the “smart” ring 206 may collect user movement (e.g., arm, hand, and finger movement) data, pulse data, temperature data, and/or any other user data known in the art that is collectable by “smart” rings, and the “smart” shoes 206 may collect user movement (e.g., foot and leg movement such as walking/running movements) data, pulse data, temperature data, and/or any other user data known in the art that is collectable by “smart” shoes (Zhao ¶0027)]
Claim 63 recites “a sensor configured to measure activity of the subject, over a period of time”, wherein claim 64 further defines the measured activity as comprising: “body movement, steps, amount of movement, intensity of movement, length of movement, rate of movement, velocity of movement, repetition of movement, posture changes, or any combination thereof”. Such a “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 “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)]
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 “one or more sensors for measuring one or more physiological parameters of the subject” is/are 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 “one or more sensors for measuring one or more physiological parameters of the subject”, and recites the “one or more sensors” at a high level of generality [Applicant’s Specification p. 14:7-11]. 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 physiological 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 [Arikka Col 2:28-34]
Bartholomew (US-20110288381-A1, previously presented) [providing a user with a substantially standard heart rate strap as a physiologic monitor 102, like that known in the art for detecting an instantaneous heart rate reading (Bartholomew ¶0031)]
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 “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) 49-68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kahn (US-20130072765-A1) in view of Provost (“Differences in Gait Across the Menstrual Cycle and Their Attractiveness to Men”, NPL attached) and Roelofs (“Pedometer readings for estrous detection and as predictor for time of ovulation in dairy cattle”, NPL attached).
Regarding claim 49, Kahn teaches
A non-invasive method for determining or predicting ovulation timing in human subject, the method comprising:
measuring activity of the subject over a period of time, said activity comprise steps taken by the subject [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)].
However, while Kahn discloses processing steps to determine the subject’s ovulation cycle based on pattern analysis [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)], Kahn fails to explicitly disclose determining a pattern in the steps of the subject over the period of time; wherein the pattern is indicative of ovulation.
Provost discloses methods for assessing gait and menstrual cycles, wherein Provost indicates that women exhibit changes in gait depending on the phase of the menstrual cycle [These studies add further evidence to the position that ovulation is unadvertised, not concealed. They demonstrate that there are changes in gait among naturally cycling women across the menstrual cycle, and that men are attuned to differences across the cycle at some level (Provost p. 603)].
Roelofs discloses methods for predicting ovulation, wherein Roelofs discloses that patterns in the steps of mammals, such as cows, are indicative of ovulation [The results of this study show that the increase in the number of steps preceding ovulation can be used to detect estrus and to predict time of ovulation fairly accurate. Ovulation occurred approximately 29 h (ranging from 22 to 39 h) after onset of pedometer estrus (using S.D. 3) (Roelofs p. 1699)].
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 determining a pattern in the steps of the subject over the period of time; wherein the pattern is indicative of ovulation, as this modification would amount to merely applying a known technique [pattern analysis to determine ovulation (Kahn ¶0039); step patterns in mammals being indicative of ovulation (Roelofs p. 1699)] to a known device (method, or product) ready for improvement to yield predictable results [MPEP § 2143(I)(D)], as Provost and Roelofs indicate gait variability based on ovulation cycles in women and mammals, respectively.
Regarding claim 50, Kahn in view of Provost and Roelofs 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 Provost and Roelofs 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].
Regarding claim 52, Kahn in view of Provost and Roelofs teaches
The method according to claim 49, wherein the activity of the subject is measured during waking hours of the subject [Kahn ¶0040].
Regarding claim 53, Kahn in view of Provost and Roelofs teaches
The method according to claim 49, wherein the pattern comprises one or more changes in values of the measured activity during one or more interim periods of the period of time, and/or one or more changes in parameters derived from the values of the measured activity during one or more interim periods of the period of time [Roelofs p. 1699].
Regarding claim 54, Kahn in view of Provost and Roelofs teaches
The method according to claim 53, wherein parameters derived from the values of the measured activity comprises normalized values of said parameters, intraday values of the parameters, trends of said values, or any combination thereof [Roelofs p. 1699].
Regarding claim 55, Kahn in view of Provost and Roelofs teaches
The method according to claim 49, wherein an increase in the measured activity in an interim period of the period of time and/or an increase in parameters derived from the measured activity values are indicative of ovulation time [Roelofs p. 1699].
Regarding claim 56, Kahn in view of Provost and Roelofs 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 [Roelofs p. 1699].
Regarding claim 57, Kahn in view of Provost and Roelofs 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 Provost and Roelofs teaches
The method according to claim 49, wherein the time period is in the length of about 2-45 days [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 modified 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 2-45 days].
Regarding claim 59, Kahn in view of Provost and Roelofs teaches
The method according to claim 49, wherein the pattern is determined over the entire time period, or over and between portions of the time period [Roelofs p. 1699].
Regarding claim 60, Kahn in view of Provost and Roelofs teaches
The method according to claim 49, wherein for the determining, at least one related calculation is performed using a processing unit; and/or wherein one or more of the measurements are performed using a wearable device [Kahn ¶0040].
Regarding claim 61, Kahn in view of Provost and Roelofs teaches
The method according to claim 60, wherein data obtained by the wearable device is processed by the processing unit, and wherein the wearable device and the processing unit are configured to operate in conjunction [Kahn ¶0040].
Regarding claim 62, Kahn in view of Provost and Roelofs 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); wherein based on the § 103 modification above, the ovulation indication is based on the activity pattern].
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, over a period of time, said activity comprise 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)]; and
a processing unit [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).
However, while Kahn discloses processing steps to determine the subject’s ovulation cycle based on pattern analysis [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)], Kahn fails to explicitly disclose wherein the processing unit is configured to determine a pattern of the measured activity, over the period of time; wherein the pattern is indicative of ovulation.
Provost discloses methods for assessing gait and menstrual cycles, wherein Provost indicates that women exhibit changes in gait depending on the phase of the menstrual cycle [These studies add further evidence to the position that ovulation is unadvertised, not concealed. They demonstrate that there are changes in gait among naturally cycling women across the menstrual cycle, and that men are attuned to differences across the cycle at some level (Provost p. 603)].
Roelofs discloses methods for predicting ovulation, wherein Roelofs discloses that patterns in the steps of mammals, such as cows, are indicative of ovulation [The results of this study show that the increase in the number of steps preceding ovulation can be used to detect estrus and to predict time of ovulation fairly accurate. Ovulation occurred approximately 29 h (ranging from 22 to 39 h) after onset of pedometer estrus (using S.D. 3) (Roelofs p. 1699)].
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 determining a pattern in the steps of the subject over the period of time; wherein the pattern is indicative of ovulation, as this modification would amount to merely applying a known technique [pattern analysis to determine ovulation (Kahn ¶0039); step patterns in mammals being indicative of ovulation (Roelofs p. 1699)] to a known device (method, or product) ready for improvement to yield predictable results [MPEP § 2143(I)(D)], as Provost and Roelofs indicate gait variability based on ovulation cycles in women and mammals, respectively.
Regarding claim 64, Kahn in view of Provost and Roelofs 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 Provost and Roelofs teaches
The wearable device according to claim 63, wherein the pattern determined by the processing unit comprises one or more changes in values of the measured activity during one or more interim periods of the period of time, and/or one or more changes in parameters derived from the values of the measured activity during one or more interim periods of the period of time; and/or wherein parameters derived from the values of the measured activity comprises normalized values of said parameters, intraday values of the parameters, trends of said measured values, or any combinations thereof [Roelofs p. 1699].
Regarding claim 66, Kahn in view of Provost and Roelofs teaches
The device according to claim 65, wherein an increase in the value of the measured activity in an interim period of the period of time, as determined by the processing unit, and/or an increase in parameters derived from the measured activity values is indicative of ovulation time [Roelofs p. 1699].
Regarding claim 67, Kahn in view of Provost and Roelofs 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 Provost and Roelofs teaches
The device according to claim 63, further comprising an alert unit configured to issue an indication regarding ovulation occurrence [Kahn ¶0107, wherein based on the § 103 modification above, the ovulation indication is based on the activity pattern].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 5, filed 26 October 2025, with respect to the previously presented claim objections have been fully considered and are persuasive. The claim objections of claims 49 and 68 have been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 6, with respect to the previously applied claim rejections under § 112(b) have been fully considered but they are not entirely persuasive. Please see above for maintained rejections.
Applicant's arguments, see Applicant’s Remarks p. 6-10, with respect to the previously applied claim rejections under § 101 have been fully considered but they are not persuasive.
The Applicant asserts that the claims are not directed to the abstract idea alone but are integrated into a practical, technological application through the unique combination of physical elements and constrained processing at Step 2A Prong 2, including: 1. Non-generic gathering/analysis [collection and processing of a specific type of non-physiological activity data by a wearable device]; 2. Specific technological solution [“determination” limitation(s) identified as the abstract idea cannot be practically performed by the human mind or with pen and paper due to “the volume, frequency, and computational complexity required to continuously measure activity over an extended period (e.g. 2-45 days)”, and further limitations based on the determination thereof]; 3. Improvement in a technical field [improvement in the function of non-invasive health diagnostics and remote patient monitoring; August 4, 2025 memorandum]. However, the Examiner disagrees with the Applicant’s arguments:
1. The collection and processing of a “specific type of non-physiological activity data” is still considered to amount to generic data gathering, as the data gathered is considered to be pre-solution for use in the claimed processes using said data and the “particularity” of the type of data is still considered to be insignificant extra-solution activity based on the MPEP [Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); Determining the level of a biomarker in blood, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring data derived from an ultrasound scan, to be used in a diagnosis) (MPEP § 2106.05(g))];
2. The argued limitations are considered to be able to be performed in the mind or by hand, as the claim language lacks sufficient particularity regarding any amount or complexity to the data gathered and analyzed as argued [it is noted that the features upon which applicant relies (i.e., “the volume, frequency, and computational complexity required to continuously measure activity over an extended period (e.g. 2-45 days)”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993); merely limiting the data gathered to be measured across 2-45 days does not provide any lower or upper boundaries to how much data is actually measured];
3. The argued improvement is considered to be recited in limitations that have been identified as being abstract ideas [determining a pattern in the steps of the of the subject over the period of time; wherein the pattern is indicative of ovulation”] implemented on a generic computer with additional elements that are considered to be well-understood, routine, and conventional. 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. Furthermore, based on the August 4, 2025 memorandum, the Examiner notes that the under the improvements consideration, the claims are still considered to merely claim the idea of a solution/outcome [determine a pattern… wherein the pattern is indicative of ovulation] and lacks particularity in the application of the judicial exception, as opposed to details of how a solution to a problem is accomplished or a particular solution to a problem or a particular way to achieve a desired outcome. The claim further merely purports to improve computer capabilities or improve an existing technology. As such, the additional elements fail to amount to more than a recitation of the words “apply it” [or equivalent] or mere instructions to implement an abstract idea or other exception on a computer.
The Applicant asserts that the specific combination of elements is sufficient to amount to significantly more than the abstract idea at Step 2B: 1. Unconventional combination [ordered combination of a sensor, processor, and alert unit are unconventional in the claimed context due to the type of processed data]; 2. Tie to specific hardware [measuring and determining steps are performed by a wearable device’s sensor(s) and processing unit(s)]. However, the Examiner disagrees with the Applicant’s arguments:
1. The argued combination of elements of a sensor, processor, and alert unit are considered to be recited at a high level of generality, and are further considered to be well-understood, routine, and conventional in the art [see Step 2B analysis, which notes that such elements are WURC], such that implementing the argued elements together is not considered to allow the allow the claims as wholes to amount to significantly more than the judicial exception.
2. The argued “specific” hardware is not considered to be particular, as the argued wearable device, sensor, and processing units are recited at a high level of generality, and are further considered to be well-understood, routine, and conventional in the art [see Step 2B analysis, which notes that such elements are WURC], and the hardware itself is merely used to in an “apply it” methodology for the judicial exception.
Applicant’s arguments, see Applicant’s Remarks p. 10-12, with respect to the rejection(s) of claim(s) 49-68 under § 102 and § 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) in view of Provost (“Differences in Gait Across the Menstrual Cycle and Their Attractiveness to Men”) and Roelofs (“Pedometer readings for estrous detection and as predictor for time of ovulation in dairy cattle”).
The Applicant asserts that Dillen fails to disclose the limitation of determining a pattern in the measured activity [or a specific non-physiological parameter like step rate/variability] that is indicative of ovulation. The Applicant further asserts that Clark does not concern fertility or ovulation prediction and merely observes statistical differences in gait variability during running and is from a non-analogous field. The Applicant also asserts that there is no teaching, suggestion, or motivation to combine Dillen in view of Clark, as Dillen is directed to continuous, long-term RHR monitoring using generalized motion data collected while the subject is at rest, while Clark relates to short-term, specialized gait analysis and injury risk assessment, measuring mediolateral acceleration variability at the tibia during steady-state running. The Applicant also points out that Dillen teaches minimizing motion interference by collecting data during rest, while Clark analyzes data during active motion, which the Applicant notes would be contradictory and lack any rational motivation or expectation of success. Applicant’s arguments with respect to claim(s) 1 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. Kahn (US-20130072765-A1) in view of Provost (“Differences in Gait Across the Menstrual Cycle and Their Attractiveness to Men”) and Roelofs (“Pedometer readings for estrous detection and as predictor for time of ovulation in dairy cattle”) is presently applied to teach the argued subject matter regarding a specific non-physiological parameter like step rate/variability being indicative of ovulation [Roelofs p. 1699].
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.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/S.P.L./Examiner, Art Unit 3791