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 .
Status of Claims
Claims 1-3, 5-13, 15-18, and 20-30 are currently pending and have been examined.
Claims 1-3, 6-9, 16-18, 21-24 and 29-30 have been amended.
Claims 4, 14, and 19 have been canceled, with claims 4 and 19 being newly canceled in the amendments filed 7/7/2026.
Claims 1-3, 5-13, 15-18, and 20-30 have been rejected.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) of claim 29 are:
means for determining a time series of a plurality of physiological measurements taken over a plurality of days based at least in part on the received physiological data
means for computing a delta between respective physiological measurements, of the plurality of physiological measurements, at different points in the time series based at least in part on determining the time series, wherein the delta is representative of a change in one or more hormone levels throughout the menstrual cycle for the user;
means for identifying that the plurality of physiological measurements deviate from a first set of baseline physiological measurements associated with a previous menstrual cycle for the user, a second set of baseline physiological measurements associated with menstrual cycles for additional users, or both
means for identifying one or more risk metrics associated with relative probabilities that the user is experiencing polycystic ovary syndrome, endometriosis, or both, based at least in part on identifying that the plurality of physiological measurements deviate from the first set of baseline physiological measurements, the second set of baseline physiological measurements, or both;
means for generating a message for display on a graphical user interface on a user device that indicates information associated with the one or more risk metrics
Because these claim limitation(s) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The Examiner has reviewed the current disclosure and identified in para 176 of the Applicant’s specification, “FIG. 10 shows a flowchart illustrating a method 1000 that supports techniques for identifying irregular cycles, PCOS, and endometriosis from wearable- based physiological data in accordance with aspects of the present disclosure. The operations of the method 1000 may be implemented by a user device or its components as described herein. For example, the operations of the method 1000 may be performed by a user device as described with reference to FIGs. 1 through 9. In some examples, a user device may execute a set of instructions to control the functional elements of the user device to perform the described functions,” wherein paragraph 23 of the Applicant’s specification discloses the user device 106 can be a smartphone, laptop, or tablet. In light of paragraph 23 and claim 16, there is support in the specification and claim 16 for the apparatus implementing the method of claim 1.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-3, 5-13 and 15-18, and 20-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to an abstract idea without significantly more. Claims 1-3, 5-13 and 15-18, and 20-30 are directed to a system, method, or product which are one of the statutory categories of invention. (Step 1: YES).
Independent Claim 1 discloses a method comprising: acquiring, via one or more sensors of a wearable ring device configured to be worn by a user, physiological data associated with the user, the physiological data comprising at least temperature data; receiving, via a transceiver of a user device and from the wearable ring device, the physiological data associated with the user, the physiological data collected throughout at least a portion of a menstrual cycle for the user; determining a time series of a plurality of physiological measurements taken over a plurality of days based at least in part on the physiological data; computing a delta between respective physiological measurements, of the plurality of physiological measurements, at different points in the time series based at least in part on determining the time series, wherein the delta is representative of a change in one or more hormone levels throughout the menstrual cycle for the user; identifying that the plurality of physiological measurements deviate from a set of baseline physiological measurements associated with menstrual cycles for additional users based at least in part on the delta, wherein identifying that the plurality of physiological measurements deviate from the set of baseline physiological measurements comprises: identifying that a portion of the physiological data collected during a follicular phase of the menstrual cycle is lower than baseline follicular phase physiological data associated with the menstrual cycles for the additional users, identifying one or more risk metrics associated with relative probabilities that the user is experiencing polycystic ovary syndrome, endometriosis, or both, based at least in part on identifying that the portion of physiological data collected during the follicular phase of the menstrual cycle is lower than the baseline follicular phase physiological data; and generating a message for display on a graphical user interface on the user device that indicates information associated with the one or more risk metrics.
Independent Claim 16 discloses a system comprising: one or more processors; and one or more memories coupled with the one or more processors; and instructions stored in the one or more memories and executable by the one or more processors to: acquire, via one or more sensors of a wearable ring device configured to be worn by a user, physiological data associated with the user, the physiological data comprising at least temperature data; receive, via a transceiver of a user device and from the wearable ring device, the physiological data associated with the user, the physiological data collected throughout at least a portion of a menstrual cycle for the user; determine a time series of a plurality of physiological measurements taken over a plurality of days based at least in part on the physiological data; compute a delta between respective physiological measurements, of the plurality of physiological measurements, at different points in the time series based at least in part on determining the time series, wherein the delta is representative of a change in one or more hormone levels throughout the menstrual cycle for the user; identify that the plurality of physiological measurements deviate from a set of baseline physiological measurements associated with menstrual cycles for additional users based at least in part on the delta, wherein, to identify that the plurality of physiological measurements deviate from the set of baseline physiological measurements, the instructions to are executable by the one or more processors to: identify that a portion of the physiological data collected during a follicular phase of the menstrual cycle is lower than baseline follicular phase physiological data associated with the menstrual cycles for the additional users; identify one or more risk metrics associated with relative probabilities that the user is experiencing polycystic ovary syndrome, endometriosis, or both, based at least in part on identifying that the portion of physiological data collected during the follicular phase of the menstrual cycle is lower than the baseline follicular phase physiological data; and generate a message for display on a graphical user interface on the user device that indicates information associated with the one or more risk metrics.
Independent Claim 29 discloses an apparatus, comprising: means for acquiring, via one or more sensors of a wearable ring device configured to be worn by a user, physiological data associated with the user, the physiological data comprising at least temperature data; means for receiving, via a transceiver of a user device and from the wearable ring device, the physiological data associated with the user, the physiological data collected throughout at least a portion of a menstrual cycle for the user; means for determining a time series of a plurality of physiological measurements taken over a plurality of days based at least in part on the physiological data; means for computing a delta between respective physiological measurements, of the plurality of physiological measurements, at different points in the time series based at least in part on determining the time series, wherein the delta is representative of a change in one or more hormone levels throughout the menstrual cycle for the user; means for identifying that the plurality of physiological measurements deviate from a set of baseline physiological measurements associated with menstrual cycles for additional users based at least in part on the delta, wherein the means for identifying that the plurality of physiological measurements deviate from the set of baseline physiological measurements comprises: means for identifying that a portion of the physiological data collected during a follicular phase of the menstrual cycle is lower than baseline follicular phase physiological data associated with the menstrual cycles for the additional users; means for identifying one or more risk metrics associated with relative probabilities that the user is experiencing polycystic ovary syndrome, endometriosis, or both, based at least in part on identifying that the portion of physiological data collected during the follicular phase of the menstrual cycle is lower than the baseline follicular phase physiological data; and means for generating a message for display on a graphical user interface on the user device that indicates information associated with the one or more risk metrics.
Independent Claim 30 discloses a non-transitory computer-readable medium storing code, the code comprising instructions executable by a processor to: acquire, via one or more sensors of a wearable ring device configured to be worn by a user, physiological data associated with the user, the physiological data comprising at least temperature data; receive, via a transceiver of a user device and from the wearable ring device, the physiological data associated with the user, the physiological data collected throughout at least a portion of a menstrual cycle for the user; determine a time series of a plurality of physiological measurements taken over a plurality of days based at least in part on the physiological data; compute a delta between respective physiological measurements, of the plurality of physiological measurements, at different points in the time series based at least in part on determining the time series, wherein the delta is representative of a change in one or more hormone levels throughout the menstrual cycle for the user; identify that the plurality of physiological measurements deviate from a set of baseline physiological measurements associated with menstrual cycles for additional users based at least in part on the delta, wherein, to identify that the plurality of physiological measurements deviate from the set of baseline physiological measurements, the instructions are executable by the processor to: identify that a portion of the physiological data collected during a follicular phase of the menstrual cycle is lower than baseline follicular phase physiological data the menstrual cycles for the additional users; identify one or more risk metrics associated with relative probabilities that the user is experiencing polycystic ovary syndrome, endometriosis, or both, based at least in part on identifying that the portion of physiological data collected during the follicular phase of the menstrual cycle is lower than the baseline follicular phase physiological data; and generate a message for display on a graphical user interface on the user device that indicates information associated with the one or more risk metrics.
The examiner is interpreting the above bolded limitations as additional elements as further discussed below. The remaining un-bolded limitations are merely directed to identifying a risk metrics of a patient based on physiological data. The series of steps recited above describe managing personal behavior or relationships or interactions between people and thus are grouped as certain methods of organizing human activity which is an abstract idea. (Step 2A- Prong 1: YES. The claims are abstract).
This judicial exception is not integrated into a practical application. Limitations that are not indicative of integration into a practical application include: (1) Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (MPEP 2106.05.f), (2) Adding insignificant extra- solution activity to the judicial exception (MPEP 2106.05.g), (3) Generally linking the use of the judicial exception to a particular technological environment or field of use (MPEP 2106.05.h).
Independent Claims 1 disclose the following additional elements:
acquiring, via one or more sensors of a wearable ring device configured to be worn by a user, physiological data associated with the user;
receiving, via a transceiver of a user device and from the wearable ring device, the physiological data associated with the user
display on a graphical user interface on the user device
Independent Claim 16 discloses the following additional elements:
one or more processor
one or more memories coupled with the one or more processors
instructions stored in the one or more memories and executable by the one or more processors
acquire, via one or more sensors of a wearable ring device configured to be worn by a user, physiological data associated with the user; receive, via a transceiver of a user device and from the wearable ring device, the physiological data associated with the user, the physiological data collected throughout at least a portion of a menstrual cycle for the user
display on a graphical user interface on the user device
Independent Claim 29 discloses the following additional elements;
means for acquiring, via one or more sensors of a wearable ring device configured to be worn by a user, physiological data associated with the user; means for receiving, via a transceiver of a user device and from the wearable ring device, the physiological data associated with the user, the physiological data collected throughout at least a portion of a menstrual cycle for the user
display on a graphical user interface on the user device
Independent Claim 30 discloses the following additional elements:
a non-transitory computer-readable medium storing code, the code comprising instructions executable by a processor
acquire, via one or more sensors of a wearable ring device configured to be worn by a user, physiological data associated with the user; receive, via a transceiver of a user device and from the wearable ring device, the physiological data associated with the user collected via a wearable device, the physiological data collected throughout at least a portion of a menstrual cycle for the user
display on a graphical user interface on the user device
In particular, display[ing] on a graphical user interface on a user device (of claims 1, 16, and 29-30), one or more processors (of claims 16), one or more memories coupled with the one or more processors (of claim 16), instructions stored in the one or more memories and executable by the one or more processors (of claim 16), a non-transitory computer-readable medium storing code, the code comprising instructions executable by a processor (of claim 30) are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea by adding the words ‘apply it’ (or an equivalent) with the judicial exception.
Applicant’s specification para 261 states - user devices 106 may include handheld mobile computing devices, such as smartphones and tablet computing devices. User devices 106 may also include personal computers, such as laptop and desktop computing devices. Other example user devices 106 may include server computing devices that may communicate with other electronic devices (e.g., via the Internet).
Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Additionally, acquiring, via one or more sensors of a wearable ring device configured to be worn by a user, physiological data associated with the user; receiving, via a transceiver of a user device and from the wearable ring device, the physiological data associated with the user, the physiological data collected throughout at least a portion of a menstrual cycle amounts to insignificant extra-solution activity. The additional elements, even in combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Accordingly, claim(s) 1, 16, and 29-30 are directed to an abstract idea(s) without a practical application. (Step 2A-Prong 2: NO: the additional claimed elements are not integrated into a practical application).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of display[ing] on a graphical user interface on a user device (of claims 1, 16, and 29-30), one or more processors (of claims 16), one or more memories coupled with the one or more processors (of claim 16), instructions stored in the one or more memories and executable by the one or more processors (of claim 16), a non-transitory computer-readable medium storing code, the code comprising instructions executable by a processor (of claim 30) amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more’). MPEP2106.05(I)(A) indicates that merely saying "apply it” or equivalent to the abstract idea cannot provide an inventive concept ("significantly more").
Further, acquiring, via one or more sensors of a wearable ring device configured to be worn by a user, physiological data associated with the user; receiving, via a transceiver of a user device and from the wearable ring device, the physiological data associated with the user, the physiological data collected throughout at least a portion of a menstrual cycle (claims 1, 16, and 29-30) were considered insignificant extra-solution activity in Step 2A, Prong 2. Re-evaluating here in step 2B, these are also determined to be well-understood, routine, conventional activity in the field. The Mayo and OIP Techs court decisions cited in MPEP 2106.05(g) indicate that mere data gathering is well-understood, routine, conventional activity in the field.
Accordingly, even in combination, these additional elements do not provide significantly more. As such the independent claims 1, 16, and 29-30 are not patent eligible. (Step 2B: NO. The claims do not provide significantly more).
Dependent claim(s) 2-3, 5-15, 17-18, and 20-28 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Dependent claims 13 and 28 do further disclose the additional element(s) of a machine learning classifier (claims 13 and 28).
In particular, the machine learning classifier (of claims 13 and 28) is recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea by adding the words ‘apply it’ (or an equivalent) with the judicial exception. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Accordingly, this additional element does not integrate the abstract idea into a practical application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of the machine learning classifier (of claims 13 and 28) amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more’). MPEP2106.05(I)(A) indicates that merely saying "apply it” or equivalent to the abstract idea cannot provide an inventive concept ("significantly more"). Accordingly, this additional element does not provide significantly more.
Therefore, the dependent claims are also directed to an abstract idea.
Thus, Claims 1-3, 5-13 and 15-18, and 20-30 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Subject Matter Free of Prior Art
Claims 1-3, 5-13 and 15-18, and 20-30 contain subject matter free of prior art. Below are the most relevant prior art references and an explanation of why the claims contain subject matter free of prior art.
Sano (US PG Pub 2017/0319184 A1) discloses the present invention relates to an information processing technique concerned with obstetrics and gynecology which deal with women's diseases… Besides infertility, the women's diseases include premenstrual syndrome (PMS), menopausal disorder, corpus luteum insufficiency, endometriosis, and the like” (Paras 1-2) and PCOS (Para 308). Further, Para 64-65 disclose the body temperature-menstruation data input unit 21 of the terminal 2 of the user inputs the data of the body temperature and the like from the medical device 3 by communication… the terminal 2 of the user and the medical device 3 may be wearable terminals having the sensor function. In this case, the wearable terminal automatically measures the body temperature and values of other predetermined items concerned with the health state of the user and records the data. Para 94 discloses a disease risk warning function estimates and checks the health state of the user, including the disease and the like, by comprehensive analysis using the above elements such as the user's body temperature, the menstruation, the examination result, the action, the symptom, and the note in combination… Depending on the results, the disease risk warning function outputs a message warning of the possibility and the risk of the disease. Para 100 discloses moreover, when the medical device 3 keeps the body temperature data in time series or in a graph format or has information such as menstruation, height, weight, and body mass index (BMI) besides the body temperature all together, these data may be collectively input into the application 20 of the terminal 2.
Narasimhan (US PG Pub 2018/0206745 A1) Para 26 discloses the blood pressure monitoring device 100, device 100 for short, may be worn or engaged with a digital artery, e.g., a finger, to determine the blood pressure of a user, along with other diagnostic data. In some embodiments, the other diagnostic data may include hear rate (HR), respiratory rate (RR), temperature [thus disclosing temperature data], and blood oxygen saturation (SpO2)… The external reader may record the data, alert the user and/or user's physician to readings outside of designated ranges, or transmit the data to an electronic medical record associated with the user, for example. Para 21 discloses a device that is portable, compact, less intrusive and simple to operate.
Pardey (UK Patent GB2533614) Page 53, lines 1-5 disclose late ovulation is determined for any ovulation event that occurs more than 65% of the way through the cycle e.g. day 20 or more in a 30 day cycle. Late ovulation is likely to occur with PCO and PCOS and is useful for the diagnosis of both. An indication of the timing of ovulation within the cycle is also useful for informing a user of when intercourse is most likely to result in a natural pregnancy… 4. “Anovulation” A determination of anovulation can be made if no ovulation event is detected for 180 days or more, with or without menstruation. This is likely to occur with PCOS only [no ovulation is a risk metric of PCOS] and can be particularly useful information to provide for the diagnosis of PCOS.
Goeckenjan (Continuous Body Temperatures Monitoring to Improve the Diagnosis of Female Infertility). (Abstract Results section discloses statistically significant differences were found in the temperature curves of women with luteal phase deficiency and polycystic ovary syndrome compared to women with normal menstrual cycles [baseline follicular phase physiological data associated with menstrual cycles for additional users]. The analysis of individual cyclofertilograms can be used to detect cycle phases and estimate the date of ovulation… Abstract Conclusion section discloses continuous body temperature monitoring with a vaginal biosensor can improve the standard diagnostic procedures used to determine ovulatory dysfunction, especially if dysfunction is due to luteal phase deficiency and polycystic ovary syndrome. Analysis of the lowest daily body temperature combined with the basal body temperature measurements used in fertility awareness methods may be equieffective to continuous body temperature measurements with OvulaRing… Results Polycystic ovary syndrome (PCOS) section discloses the temperature curves of women with positive Rotterdam criteria were compared with those of women with normal values… women with PCOS-typical ovarian sonomorphology had a significantly: longer total menstrual cycle (p = 0.007), follicular phase (OvulaRing; p = 0.022) and lower temperature phase based on the analysis of lowest daily body temperatures using selected rules on temperature changes (p = 0.01); later ovulation date based on OvulaRing analysis (p = 0.022) and a later temperature shift according to NFP methods of temperature analysis (p = 0.009). Further, that section discloses the temperature curves of women diagnosed with PCOS based on the Rotterdam criteria also showed significant differences compared to the other women in the study. Women with PCOS had: a longer lower temperature phase based on the analysis of lowest daily body temperatures using selected rules on temperature changes (p = 0.004); a later temperature shift based on the analysis of lowest daily body temperatures using selected rules on temperature changes (p = 0.03).)
Shinar (US PG Pub 2015/0327792 A1). Abstract discloses the control unit received an indication of a menstrual cycle of the subject. Taking into account the subject's menstrual cycle, the control unit identifies a baseline value of the clinical parameter, compares the identified clinical parameter to the baseline value, and, in response to the comparing, the control unit (a) determines whether a clinical episode is predicted, (b) determines whether a clinical episode is currently occurring, and/or (c) monitors an occurring clinical episode. The control unit generates an output in response thereto. Para 175 discloses the clinical parameter is selected from the group consisting of: respiratory rate, and heart rate, the control unit being configured to identify the selected clinical parameter. Para 302-303 discloses module 22 compares one or more of the following patterns to respective baseline patterns, and interprets a deviation from baseline as indicative of (a) the onset of an attack, and/or (b) the severity of an attack in progress: interruptions in breathing pattern such as caused by coughs, sleep disturbances, or waking. Module 22 quantifies these events, and determines their relevance to prediction of potential asthma attacks [risk metrics]. Para 357-358 discloses normal breathing patterns in sleep are likely to be subject to slow changes over days, weeks, months and years. Some changes are periodic due to periodic environmental changes like change in seasons, or to a periodic schedule such as a weekly schedule (for example outdoor play every Saturday), or biological cycles such as the menstrual cycle.) In an embodiment of the present invention, system 10 is adapted to monitor parameters of the patient including breathing rate, heart rate, coughing counts, expiration/inspiration ratios, augmented breaths, deep inspirations, tremor, sleep cycle, and restlessness patterns, among other parameters. These parameters are defined herein as “clinical parameters.”.)
Shelton (WO 2022/157694 A1). Para 210 discloses menstrual phase may provide context for various surgical outcomes. The menstrual cycle may provide context for biomarkers, complications, and/ or conditions, including those related to the reproductive system. Para 242 discloses risk of endometriosis may be predicted based on the analyzed menstrual cycle. Para 332 discloses the biomarkers may include, for example, Blood pH, hydration state, oxygen saturation, core body temperature, heart rate, heart rate variability, Sweat rate, Skin conductance, Blood pressure, Tight exposure, Environmental temperature, Respiratory rate, Coughing and sneezing, Gastrointestinal motility, Gastrointestinal tract imaging, Tissue perfusion pressure, Bacteria in respiratory tract, Alcohol consumption, Eactate (sweat), Peripheral temperature, Positivity and optimism, Adrenaline (sweat), Cortisol (sweat), Edema, Mycotoxins, VO2 max, Pre-operative pain, chemicals in the air, Circulating tumor cells, Stress and anxiety, Confusion and delirium, Physical activity, Autonomic tone, Circadian rhythm, Menstrual cycle, Sleep, etc.
Neumann (US Patent 11,170,898 B2) (Column 12, lines 39-45 discloses generating an optimal vector output 136 includes displaying the optimal vector output 136 containing a suspected disease state 140 to a user, receiving a user entry containing a datum of user genetic history, and updating the optimal vector output 136 containing a new suspected disease state 140 as a function of the user entry. Column 13, lines 49-53 discloses optimal vector output 136 may be updated to select and/or eliminate suspected disease state 140 as a function of user entry containing a datum of user genetic history. Column 14, lines 2-5 disclose a datum of user genetic history showing ancestry [family history] that is not of sub-Saharan African ancestry may be utilized to eliminate a suspected disease state 140 that includes sickle-cell anemia. (Column 18, lines 8-22 discloses triage module 148 is configured to generate using a supervised machine-learning processes a disease criticality model that outputs a disease criticality score 164 for each of the plurality of suspected disease state 140 utilizing the selected triage training data 156. Supervised machine-learning processes may include classification algorithms, defined as processes whereby a computing device 104 derives, from training data, a model for sorting inputs into categories or bins of data. Classification may be performed using, without limitation, linear classifiers such as without limitation logistic regression and/or naive Bayes classifiers, nearest neighbor classifiers, support vector machines, decision trees, boosted trees, random forest classifiers, and/or neural network-based classifiers. Column 21, lines 34-37 discloses optimal vector output 136 may be generated by receiving a user entry containing a datum of user genetic history which may be utilized to update a suspected disease state 140 contained within an optimal vector output 136. For instance and without limitation, a datum of user genetic history that contains one copy of the apolipoprotein E gene may be utilized to select between two optimal vector output 136 whereby a first optimal vector output 136 contains a suspected disease state 140 such as coronary artery disease and a second optimal vector output 136 contains a suspected disease state 140 such as anxiety disorder. )
Haney (US PG Pub 2023/0210503 A1) discloses a wearable computing device that can estimate a user’s internal or external temperature to automatically determine some menstrual cycle data for a user. This physiological data is then used alongside biometric data to determine a menstrual cycle group for a user.
Chai (Basal body temperature and endometriosis) Abstract discloses a significant association was found between the presence of pelvic endometriosis (without previous treatment) and the appearance of a late decline in BBT during the early follicular phase of the menstrual cycle.
While the above references read on various limitations of the claims of the instant application and while there are references that indicate endometriosis can be determined by identifying that a portion of physiological data collected during the follicular phase of the menstrual cycle is higher than the baseline follicular phase physiological data [associated with the menstrual cycles for the additional users] as indicated by a late decline in BBT (see Chai above ) and there are references that indicate that PCOS can be determined by identifying that the follicular phase (the low temperature phase) is longer than the follicular phase of a woman without PCOS (see Goeckenjan above), none of the above prior art references, nor any prior art reference, disclose, “identifying that the plurality of physiological measurements [the physiological measurements… based at least in part on the physiological data wherein the physiological data comprises at least temperature data] deviate from a set of baseline physiological measurements associated with menstrual cycles for additional users based at least in part on the delta, wherein identifying that the plurality of physiological measurements deviate from the set of baseline physiological measurements comprises: identifying that a portion of the physiological data collected during a follicular phase of the menstrual cycle is lower than baseline follicular phase physiological data associated with the menstrual cycles for the additional users, identifying one or more risk metrics associated with relative probabilities that the user is experiencing polycystic ovary syndrome, endometriosis, or both, based at least in part on identifying that the portion of physiological data collected during the follicular phase of the menstrual cycle is lower than the baseline follicular phase physiological data” wherein the claim discloses that the “baseline follicular phase physiological data is associated with the menstrual cycles for the additional users.” Therefore, claims 1-3, 5-13, 15-18, and 20-30 contain subject matter free of prior art.
Response to Arguments
Applicant’s arguments filed 7/7/2026 with respect to 35 U.S.C. § 112(a) and 112(b) have been fully considered and are persuasive in light of the amendments filed 7/7/2026 wherein the “first” and “second” language was removed from the baseline limitations. There is now only one set of baseline physiological measurements and there is no longer a first set associated with a second set. Therefore, the previous 35 U.S.C. 112(a) and 112(b) rejections have been removed in light of the amendments.
Applicant’s arguments filed 7/7/2026 with respect to 35 U.S.C. § 101 have been fully considered, but are not persuasive.
The Applicant argues that the amended claims recite an ordered combination of elements that amounts to “significantly more” than any alleged abstract idea under Step 2B. The Applicant then argues that the amended claim now recites the delta limitations wherein “’computing a delta’ is not mere data gathering or insignificant extra-solution activity.” The Examiner notes that the delta limitation was previously disclosed in claims 4 and 19 which, as previously presented, are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Further, the Applicant argues that the data transformation “is a concrete technical operation with a defined input and a defines output, and it imposes meaningful limitations on how the claimed method operates. The Examiner respectfully disagrees. MPEP 2106.05(c) recites, “For data, mere "manipulation of basic mathematical constructs [i.e.,] the paradigmatic ‘abstract idea,’" has not been deemed a transformation. CyberSource v. Retail Decisions, 654 F.3d 1366, 1372 n.2, 99 USPQ2d 1690, 1695 n.2 (Fed. Cir. 2011) (quoting In re Warmerdam, 33 F.3d 1354, 1355, 1360, 31 USPQ2d 1754, 1755, 1759 (Fed. Cir. 1994)),” and further, “it is noted that while the transformation of an article is an important clue, it is not a stand-alone test for eligibility.” The data transformation the Applicant points to similarly does not integrate the abstract idea into a practical application or provide significantly more as the computing of the delta describes a basic manipulation of data and is not a transformation within the meaning of the term “transformation.” Because no transformation is present in Applicant’s claimed invention, a practical application is not present. As such, this argument is not persuasive.
The Applicant then argues the ordered combination (of the instant application) is analogous to the claims found patent-eligible in McRO, Inc, v. Bandai Namco Games Am, Inc. where the Federal Circuit held that claims reciting specific rules applied to specific data inputs in a specific sequence were not directed to an abstract idea because they recited “a specific asserted improvement in computer animation.” The Examiner respectfully disagrees that the claims of the instant application are analogous to those found patent-eligible in McRO, Inc, v. Bandai Namco Games Am, Inc. In McRO, the claims were eligible because they allowed a computer to perform 3-D lip syncing animation using a new morph weight algorithm that allowed the computer to perform animation tasks that only a human could previously perform and thus provided an improvement to a technology. The claims of the instant application do not improve the computer or machine learning algorithm in such a way that it is able to perform a function it was previously unable to perform. Therefore, the claims of the instant application are not analogous to those of McRO, thus, this argument is not persuasive.
Further, the Applicant argues that the Examiner “improperly dissects the claim into individual elements and evaluates each in isolation,” and argues that the Examiner has not addressed how the ordered combination of computing a delta from time-series wearable ring data, comparing the user’s follicular-phase data against a population-level baseline derived from additional users, and using that comparison to generate PCOS/endometriosis risk metrics fails to provide significantly more. The Examiner respectfully disagrees. The limitations regarding the delta were previously presented in claims 4 and 19. As the Examiner previously determined, these limitations further narrowed the abstract idea. The abstract idea cannot provide significantly more than itself or integrate itself into a practical application.
Further, the Examiner previously analyzed the additional elements of the independent and dependent claims individually and in combination and found that the additional elements did not integrate the abstract idea into a practical application or provide significantly more. Further, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually as there is no indication that the combination of elements improves the functioning of a computer or improves any other technology in the claimed invention. As such, this argument is not persuasive.
The Applicant then argues that the Examiner’s Step 2B finding is procedurally deficient under Berkheimer, and states that the Examiner’s evidence addresses only one narrow subset of the additional elements, namely, the data acquisition and transmission steps and argues that the Examiner has not provided evidence that the ordered combination of steps a-c regarding the delta amendments are well-understood, routine, and conventional activities in the field of the invention. The Examiner notes that these limitations were previously disclosed in claims 4 and 19 and were found to further narrow the abstract idea. MPEP 2106.05(I) states: “As made clear by the courts, the novelty of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter (internal quotations omitted, emphasis original).” As such, it is only the additional elements identified by the Examiner to not be part of the abstract idea that are analyzed to determine whether they represent well-understood, routine, conventional activities in the field of the invention. As such, no Berkheimer evidence is required for the elements identified to be a part of the abstract idea. The Examiner notes again that the delta steps were determined to narrow the abstract idea. As such, this argument is not persuasive.
Finally, the Applicant argues that the finding that the claimed combination is novel and non-obvious is strong evidence that the same combination cannot simultaneously be “well-understood, routine, conventional activity in the field.” The Examiner respectfully disagrees. MPEP 2106.05(d) states: “Another consideration when determining whether a claim recites significantly more than a judicial exception is whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry (emphasis added).” Further, MPEP 2106.05(I) states: “As made clear by the courts, the novelty of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter (internal quotations omitted, emphasis original).” As such, it is only the additional elements identified by the Examiner to not be part of the abstract idea that are analyzed to determine whether they represent well-understood, routine, conventional activities in the field of the invention.
In that regard, MPEP 2106.05(d)(I) indicates that in determining whether the additional elements represent well-understood, routine, conventional activities, the Examiner should consider whether the additional elements (1) provide an improvement to the technological environment to which the claim is confined, (2) whether the additional elements are mere instructions to apply the judicial exception, or (3) whether the additional elements represent insignificant extra-solution activity. The additional elements of the claims do not provide significantly more based on this inquiry.
The technological environment to which the claims are confined (a processor coupled with a memory containing instructions) is recited at a high level of generality and has been found by the courts to be insufficient to provide a practical application (see MPEP 2106.05(d)(II); Alice Corp.). The additional elements of “acquiring, via one or more sensors of a wearable ring device configured to be worn by a user, physiological data associated with the user; receiving, via a transceiver of a user device and from the wearable ring device, the physiological data associated with the user, the physiological data collected throughout at least a portion of a menstrual cycle” that were found to represent extra-solution activity were analyzed and determined to represent well-understood, routine, conventional activities in the field. As such, when viewed either individually or as an ordered combination, the additional elements do not provide significantly more to the abstract idea and the claims are not subject matter eligible.
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 SARA J MORICE DE VARGAS whose telephone number is (703)756-4608. The examiner can normally be reached M-F 8:30-5:30 pm.
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/SARA JESSICA MORICE DE VARGAS/Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
