DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 5th, 2026 has been entered.
Claims 1-15 and 17-20 remain pending in the application.
Response to Arguments
Applicant’s arguments and amendments, filed February 5th, 2026, with respect to the claim objections have been fully considered. The claim objections are withdrawn.
Applicant’s arguments, filed February 5th, 2026, with respect to the rejections under 35 U.S.C. 101 have been fully considered but are not persuasive.
At page 11, Applicant argues that claim 1 is not directed to an abstract idea because claim 1 recites specific hardware components and corresponding steps or functions that impose meaningful limitations on the scope of the claims. Examiner respectfully disagrees. In light of Applicant’s specification, the claim encompasses a time series of temperature data. See, for example, [0065-0067]. “The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea.” MPEP 2106.04(a)(2) III. There is no time limit recited for performing the steps. The claimed steps can be performed using the time series of temperature data in the human mind or by using a pen and paper with no time limit. The claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
acquiring, via a set of sensors of a wearable ring device configured to be worn by a user, physiological data associated with the user;
the wearable ring device comprises: a ring-shaped housing having an inner curved surface and an outer curved surface, wherein at least a portion of the inner curved surface is configured to contact a tissue of the user; and the set of sensors configured to acquire the physiological data associated with the user, wherein the set of sensors comprises at least a first sensor at a first radial position within the ring-shaped housing and a second sensor at a second radial position within the ring- shaped housing;
one or more processors disposed at least partially within the ring- shaped housing, the one or more processors electrically coupled with the one or more sensors, the one or more processors configured to generate physiological data associated with the user based at least in part on the light received by the one or more sensors;
a curved battery disposed at least partially within the ring-shaped housing, the curved battery electrically coupled with the one or sensors and the one or more processors;
a communication module electrically coupled with the one or more processors, the communication module configured to transmit the physiological data generated by the one or more processors;
receiving, via the communication module of the wearable ring device, the physiological data associated with the user, the physiological data comprising at least temperature data
The acquiring and receiving steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the acquiring and receiving steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the wearable ring device do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)). Furthermore, it seems as if Applicant is arguing more than what is currently claimed. The claims do not recite a set of PPG sensors, rather the claims recite a set of sensors configured to acquire physiological data, the physiological data comprising at least temperature data.
At page 12, Applicant argues that the claims are not directed to an abstract idea because claim 1 recites specific hardware components and corresponding steps or functions that recites a particular integration of features into a practical application. Examiner respectfully disagrees. Under step 2A, prong two, the addition of “a set of sensors of a wearable ring device … ring-shaped housing having an inner curved surface and an outer curved surface … the set of sensors configured to acquire the physiological data … wherein the set of sensors comprise a first sensor at a first radial position … a second sensor at a second radial position …” does not add meaningful limitations to the method as it merely adds data-gathering to perform the abstract ideas. With or without the claimed abstract idea, the set of sensors gathers data the same. Therefore, it is unclear how there can be an improvement to the technology. Under step 2B, the wearable ring device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited device, set of sensors, battery, processors, and communication module are configured to perform pre-solutional data gathering activity, the and the processor is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. See Mahmud et al., "SensoRing: An Integrated Wearable System for Continuous Measurement of Physiological Biomarkers," 2018 IEEE International Conference on Communications (ICC), Kansas City, MO, USA, 2018, pp. 1-7, doi: 10.1109/ICC.2018.8423001; Maijala et al. Nocturnal finger skin temperature in menstrual cycle tracking: ambulatory pilot study using a wearable Oura ring. BMC Women's Health 19, 150 (2019). https://doi.org/10.1186/s12905-019-0844-9; Shilaih et al., Modern fertility awareness methods: wrist wearables capture the changes in temperature associated with the menstrual cycle. Biosci Rep 21 December 2018; 38 (6): BSR20171279. doi: https://doi.org/10.1042/BSR20171279; Wark Jet al., Basal Temperature Measurement Using a Multi-Sensor Armband in Australian Young Women: A Comparative Observational Study JMIR Mhealth Uhealth 2015;3(4):e94 URL: https://mhealth.jmir.org/2015/4/e94; Rhee et al, "The ring sensor: a new ambulatory wearable sensor for twenty-four hour patient monitoring," Proceedings of the 20th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Hong Kong, China, 1998, pp. 1906-1909 vol.4, doi: 10.1109/IEMBS.1998.746970; Yu et al., "Graphene Fiber-Based Strain-Insensitive Wearable Temperature Sensor," in IEEE Sensors Letters, vol. 4, no. 10, pp. 1-4, Oct. 2020, Art no. 2501304, doi: 10.1109/LSENS.2020.3026671.
Applicant’s arguments, filed February 5th, 2026, with respect to the rejections under 35 U.S.C. 103 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.
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.
Claims 1-15 and 17-20 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 1 line 14, Claim 18 line 18, & Claim 20 line 15 (claims 2-15, 17, and 19 by virtue of dependency) recites the limitation "the light". There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear how light received by sensors is used to generate the physiological data as temperature data. The limitation is suggested to recite “in part based on light received” or “in part based on temperature received”.
Claim Rejections - 35 USC § 101
Claims 1-15 and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claims 1, 18, and 20 follows.
STEP 1
Regarding claims 1, 18, and 20, the claim recites a series of structural elements and/or a series of steps or acts”), including a device. Thus, the claim is directed to a machine and/or a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
determining, by the one or more processors, a time series of a plurality of temperature values taken over a plurality of days based at least in part on the temperature data, wherein the time series comprises a plurality of ovulatory cycles for the user;
identifying, by the one or more processors, the plurality of ovulatory cycles in the time series of the plurality of temperature values based at least in part on one or more positive slopes of the time series of the plurality of temperature values, wherein the one or more positive slopes indicate the plurality of ovulatory cycles;
comparing, by the one or more processors, the plurality of temperature values of the plurality of ovulatory cycles with current values of the plurality of temperature values
identifying, by the one or more processors, an absence of expected temperature values in the current values of the plurality of temperature values as compared from the plurality of temperature values of the plurality of ovulatory cycles;
identifying, by the one or more processors, an indication of one or more anovulatory cycles in the time series of the plurality of temperature values based at least in part on identifying the absence of the expected temperature values in the current values of the plurality of temperature values from the plurality of temperature values of the plurality of ovulatory cycles
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites wearable ring device to acquire and receive physiological data, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The acquiring and receiving does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the physiological data, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
acquiring, via a set of sensors of a wearable ring device configured to be worn by a user, physiological data associated with the user;
the wearable ring device comprises: a ring-shaped housing having an inner curved surface and an outer curved surface, wherein at least a portion of the inner curved surface is configured to contact a tissue of the user; and the set of sensors configured to acquire the physiological data associated with the user, wherein the set of sensors comprises at least a first sensor at a first radial position within the ring-shaped housing and a second sensor at a second radial position within the ring- shaped housing;
one or more processors disposed at least partially within the ring- shaped housing, the one or more processors electrically coupled with the one or more sensors, the one or more processors configured to generate physiological data associated with the user based at least in part on the light received by the one or more sensors;
a curved battery disposed at least partially within the ring-shaped housing, the curved battery electrically coupled with the one or sensors and the one or more processors;
a communication module electrically coupled with the one or more processors, the communication module configured to transmit the physiological data generated by the one or more processors;
receiving, via the communication module of the wearable ring device, the physiological data associated with the user, the physiological data comprising at least temperature data;
generating a message for display on a graphical user interface on [[the]]a user device that indicates the indication of the one or more anovulatory cycles
The acquiring and receiving steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the acquiring, receiving, and generating steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity and extra-solution activity, e.g., mere data gathering and data outputting steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claims 1, 18, and 20, the wearable ring device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited device, having the set of sensors, processors, battery, communication module, are generic sensors/components configured to perform pre-solutional data gathering activity, the graphical user interface is configured to perform insignificant extra-solution activity, and the processor is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
See Mahmud et al., "SensoRing: An Integrated Wearable System for Continuous Measurement of Physiological Biomarkers," 2018 IEEE International Conference on Communications (ICC), Kansas City, MO, USA, 2018, pp. 1-7, doi: 10.1109/ICC.2018.8423001; Maijala et al. Nocturnal finger skin temperature in menstrual cycle tracking: ambulatory pilot study using a wearable Oura ring. BMC Women's Health 19, 150 (2019). https://doi.org/10.1186/s12905-019-0844-9; Shilaih et al., Modern fertility awareness methods: wrist wearables capture the changes in temperature associated with the menstrual cycle. Biosci Rep 21 December 2018; 38 (6): BSR20171279. doi: https://doi.org/10.1042/BSR20171279; Wark Jet al., Basal Temperature Measurement Using a Multi-Sensor Armband in Australian Young Women: A Comparative Observational Study JMIR Mhealth Uhealth 2015;3(4):e94 URL: https://mhealth.jmir.org/2015/4/e94; Rhee et al, "The ring sensor: a new ambulatory wearable sensor for twenty-four hour patient monitoring," Proceedings of the 20th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Hong Kong, China, 1998, pp. 1906-1909 vol.4, doi: 10.1109/IEMBS.1998.746970; Yu et al., "Graphene Fiber-Based Strain-Insensitive Wearable Temperature Sensor," in IEEE Sensors Letters, vol. 4, no. 10, pp. 1-4, Oct. 2020, Art no. 2501304, doi: 10.1109/LSENS.2020.3026671.
The dependent claims also fail to add something more to the abstract independent claims. Claims 2-15, 16-17, and are directed to more abstract ideas, which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 5-8, 10-11, 13-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Stein (US 20200222032 A1 – previously cited) in view of von Badinski (US 10139859 B2), further in view of Pardey (US 20190110692 A1 – previously cited), and further in view of Kodama (US 6937889 B2).
Regarding claim 1, Stein discloses a method (“method”, para. [0001]) comprising: acquiring, via a set of sensors (temperature sensor system 104 having at least one temperature sensor, fig. 1, para. [0045]) of a wearable ring device (wrist wearable device 1/1A, fig. 1) configured to be worn by a user (“worn”, para. [0047]), physiological data associated with the user (“temperature”, para. [0045]), wherein the wearable ring device (1/1A, fig. 1) comprises: a ring-shaped housing (wrist band 11 with the integrated device body 10 comprising housing 15, para. [0042], 1A as seen in fig. 1) having an inner curved surface and an outer curved surface (unlabeled, but as seen in fig. 1), wherein at least a portion of the inner curved surface is configured to contact a tissue of the user (“rear side 150 … contact with the skin”, para. [0047]); and the set of sensors configured to acquire the physiological data associated with the user (“measured temperature”, para. [0045, 0073]), one or more processors (processor 13, fig. 1) disposed at least partially within the ring- shaped housing (as seen in fig. 1, para. [0048]), the one or more processors electrically coupled with the one or more sensors (para. [0048, 0054], fig. 1), the one or more processors configured to generate physiological data associated with the user based at least in part on the light received by the one or more sensors (optical sensors 101 & temperature sensors 104, fig. 1, “measurement values”, para. [0043, 0054, 0058]); and a communication module (communication module 14, fig. 1) electrically coupled with the one or more processors (“connected”, para. [0049]), the communication module configured to transmit the physiological data generated by the one or more processors (“data communication”; “transmitted”, para. [0049, 0057]); receiving, via the communication module of the wearable ring device (communication module 14 & remote computer system 3, fig. 1, “Bluetooth … receive … transmitted”, para. [0049, 0057, 0063]), the physiological data associated with the user (“data communication with an external system 3, 4”; “receive … parameters”; “temperature”, para. [0049, 0057, 0072]), the physiological data comprising at least temperature data (“temperature”, para. [0045, 0072]); determining, by the one or more processors, a time series of a plurality of temperature values taken over a plurality of days based at least in part on the temperature data (as seen in fig. 5, “measurement values … time and date”; “time windows”, para. [0054, 0059]), wherein the time series comprises a plurality of ovulatory cycles for the user(“time windows … ovulation related … plurality n of menstrual cycles”, para. [0059, 0060], “cycle”, as seen in figs. 2, 6, & 14); comparing, by the one or more processors, the plurality of temperature values of the plurality of ovulatory cycles with current values of the plurality of temperature values (“compare … values … current cycle … to values … preceding”; “skin temperature … difference or variance is smaller in the current cycle than the difference or variance values expected for ovulatory cycles”, para. [0070-0074], fig. 11, Table 3); identifying, by the one or more processors, an indication of one or more anovulatory cycles in the time series of the plurality of temperature values (“detect an anovulatory cycle … variance … parameters”, para. [0073-0074], Table 3); and generating a message for display on a graphical user interface on a user device that indicates the indication of the one or more anovulatory cycles (“event … graphical representation … display 16”; “anovulatory cycle is indicated”, para. [0063, 0074]).
Stein does not disclose wherein the set of sensors comprises at least a first sensor at a first radial position within the ring-shaped housing and a second sensor at a second radial position within the ring- shaped housing; and a curved battery disposed at least partially within the ring-shaped housing, the curved battery electrically coupled with the one or sensors and the one or more processors.
However, von Badinski directed to a wearable computing device (WCD) in the form of a ring discloses a ring-shaped housing (housing 412, as seen in fig. 4 & fig. 3B) having an inner curved surface (unlabeled, but as seen in figs. 3B & 4) and an outer curved surface (unlabeled, but as seen in figs. 3B & 4), a set of sensors (as seen in figs. 2 & 3B), a processor (processor 210, fig. 2), and a communication module (communication module 250, fig. 2), wherein the set of sensors (as seen in fig. 3B) comprises at least a first sensor (temperature sensor 320a, as seen in fig. 3B) at a first radial position within the ring-shaped housing (unlabeled, but as seen in fig. 3B) and a second sensor (light sensor 320c, as seen in fig. 3B) at a second radial position within the ring-shaped housing (unlabeled, but as seen in fig. 3B); and a curved battery (battery 480, fig. 4) disposed at least partially within the ring-shaped housing (“480 … fit inside a housing 412”, para. [0187]; claim 1, “curved battery”, fig. 4), the curved battery electrically coupled with the one or sensors and the one or more processors (“processor module 210 … battery module 280 that provides electrical power for the WCD 110”, col. 10 lines 3-21, figs. 2 & 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stein, as modified by Pardey hereinabove, such that the set of sensors comprises at least a first sensor at a first radial position within the ring-shaped housing and a second sensor at a second radial position within the ring- shaped housing; and the wearable ring device comprises a curved battery disposed at least partially within the ring-shaped housing, the curved battery electrically coupled with the one or sensors and the one or more processors, in view of the teachings of von Badinski, as such a modification would have been merely a substitution of the wrist wearable device of Stein for the wearable ring device that can be worn on the finger of von Badinski in order to acquire physiological data.
Stein, as modified by von Badinski hereinabove, does not disclose identifying, by the one or more processors, the plurality of ovulatory cycles in the time series of the plurality of temperature values based at least in part on one or more positive slopes of the time series of the plurality of temperature values, wherein the one or more positive slopes indicate the plurality of ovulatory cycles; identifying, by the one or more processors, an absence of expected temperature values in the current values of the plurality of temperature values as compared from the plurality of temperature values of the plurality of ovulatory cycles; identifying, by the one or more processors, an indication of one or more anovulatory cycles in the time series of the plurality of temperature values based at least in part on identifying the absence of the expected temperature values in the current values of the plurality of temperature values from the plurality of temperature values of the plurality of ovulatory cycles.
However, Pardey directed to providing health information in relation the user's fertility or state of ovulation discloses a time series of a plurality of temperature values taken over a plurality of days, wherein the time series comprises a plurality of ovulatory cycles for the user (“series of representative temperature values for at least two cycles”, para. [0045-0046, 0262-0265]); identifying, by the one or more processors, the plurality of ovulatory cycles in the time series of the plurality of temperature values based at least in part on one or more positive slopes of the time series of the plurality of temperature values (as seen in figs. 6-8, “temperature readings … rise … onset of phase change … gradient above a threshold level … ovulation event”, para. [0600-0604]), wherein the one or more positive slopes indicate the plurality of ovulatory cycles (“rise … ovulation event”, para. [0604], as seen in figs. 7a-7b); comparing, by the one or more processors, the plurality of temperature values of the plurality of ovulatory cycles with current values of the plurality of temperature values (figs. 7a-7b, OPC+3 (onset of phase change) event … comparison … temperature profile, para. [0262-0264, 0609, 0620-0626]); identifying, by the one or more processors, temperature values in the current values of the plurality of temperature values as compared from the plurality of temperature values of the plurality of ovulatory cycles (“none of the algorithm methods … show a temperature rise … gradient of temperature rise is still not sufficient … anovulatory”, para. [0620-0626, 0639, 0668]); identifying, by the one or more processors, an indication of one or more anovulatory cycles in the time series of the plurality of temperature values (“determining … gradient of a change … temperature values corresponds to the gradient of a change … temperatures values during each of a plurality of previous cycles”; “anovulation … no ovulation event”, para. [0262, 0639, 0668]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stein, as modified by von Badinski hereinabove, such that the method further comprises identifying, by the one or more processors, the plurality of ovulatory cycles in the time series of the plurality of temperature values based at least in part on one or more positive slopes of the time series of the plurality of temperature values, wherein the one or more positive slopes indicate the plurality of ovulatory cycles; identifying, by the one or more processors, temperature values in the current values of the plurality of temperature values as compared from the plurality of temperature values of the plurality of ovulatory cycles; identifying, by the one or more processors, an indication of one or more anovulatory cycles in the time series of the plurality of temperature values, in view of the teachings of Pardey, as this would aid in the determination of anovulation with or without menstruation by incorporating the algorithm methods OPC+2, OPC+3 and OPC+6 to determine ovulation and anovulation events.
Stein, as modified by Pardey hereinabove does not disclose identifying, by the one or more processors, an absence of expected temperature values in the current values of the plurality of temperature values as compared from the plurality of temperature values of the plurality of ovulatory cycles; identifying, by the one or more processors, an indication of one or more anovulatory cycles in the time series of the plurality of temperature values based at least in part on identifying the absence of the expected temperature values in the current values of the plurality of temperature values from the plurality of temperature values of the plurality of ovulatory cycles.
However, Kodama directed to a method and apparatus for determining pregnancy possibility discloses identifying an absence of expected temperature values (fig. 1 (a) shows normal body condition (Examiner note: normal body condition is being interpreted as expected temperature values)) in the current values of the plurality of temperature values (fig. 1 (b) shows an anovulation the temperature curve (Examiner note: the anovulation temperature curve is being interpreted as the current values)) as compared from the plurality of temperature values (fig. 1 (a) shows normal body condition) of the plurality of ovulatory cycles (“little or no noticeable variation, or no temperature transition as in the normal curve (a) … time-sequence transition or historical record of the basal body temperature”, col. 1 lines 10-43); identifying an indication of one or more anovulatory cycles in the time series of the plurality of temperature values based at least in part on identifying the absence of the expected temperature values in the current values of the plurality of temperature values from the plurality of temperature values of the plurality of ovulatory cycles (“anovulation”, col. 1 lines 10-43, as seen in fig. 1 (b), as seen in figs. 1(a)-(b)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stein, as modified by von Badinski and Pardey hereinabove, such that the method further comprises identifying, by the one or more processors, an absence of expected temperature values in the current values of the plurality of temperature values as compared from the plurality of temperature values of the plurality of ovulatory cycles; identifying, by the one or more processors, an indication of one or more anovulatory cycles in the time series of the plurality of temperature values based at least in part on identifying the absence of the expected temperature values in the current values of the plurality of temperature values from the plurality of temperature values of the plurality of ovulatory cycles, in view of the teachings of Kodama, as this would aid in determining anovulation based on little or no noticeable variation, or no temperature transition.
Regarding claim 18 Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, teaches the apparatus as the subject matter of claim 18 is analogous to the subject matter of claim 1.
Regarding claim 20 Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, teaches the non-transitory computer-readable medium storing code, the code comprising instruction executable by a processor as the subject matter of claim 18 is analogous to the subject matter of claim 1.
Regarding claims 2 and 19, Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, discloses the method of claim 1/the apparatus of claim 18, further comprising: computing a deviation in the time series of the plurality of temperature values (“variance … physiological parameters”, para. [0074], Table 3), wherein the deviation comprises a decrease in the plurality of temperature values from the plurality of temperature values of the plurality of ovulatory cycles, the absence of the plurality of temperature values following the expected temperature values of the plurality of ovulatory cycles, or both (“temperature … decreases … threshold”; “variance is smaller”; “defined detection and threshold criteria relate to a decrease of the respective physiological parameter”, para. [0070-0074, 0077], Tables 3 & 4), wherein identifying the indication of the one or more anovulatory cycles is based at least in part on computing the deviation (“variance … smaller … identified as an anovulatory cycle”, para. [0073-0074]).
Regarding claim 5, Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, discloses the method of claim 1. Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, does not expressly disclose the method further comprising: identifying one or more positive slopes of the time series of the plurality of temperature values based at least in part on determining the time series, wherein identifying the plurality of ovulatory cycles is based at least in part on identifying the one or more positive slopes.
However, Pardey discloses identifying one or more positive slopes of the time series of the plurality of temperature values based at least in part on determining the time series (as seen in figs. 6-8, “temperature data … days … temperature readings … rise … onset of phase change … gradient above a threshold level”, para. [0600-0604]), wherein identifying the plurality of ovulatory cycles is based at least in part on identifying the one or more positive slopes (as seen in figs. 6-8, “gradient above a threshold level … ovulation event”, para. [0600-0604]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, such that the method further comprises identifying one or more positive slopes of the time series of the plurality of temperature values based at least in part on determining the time series, wherein identifying the plurality of ovulatory cycles is based at least in part on identifying the one or more positive slopes, in view of the teachings of Pardey, as this would aid in determining a date of ovulation for a user based on the temperature variation pattern over several days.
Regarding claim 6, Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, discloses the method of claim 1. Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, does not disclose the method further comprising: determining each temperature value of the plurality of temperature values based at least in part on receiving the temperature data, wherein the temperature data comprises continuous daytime temperature data.
However, Pardey discloses determining each temperature value of the plurality of temperature values based at least in part on receiving the physiological data (“3-day rolling average … representative temperature value”, para. [0348, 0539]), wherein the temperature data comprises continuous daytime temperature data (“continuously”; “day time periods”; “day time windows”, para. [0490, 0539-0540, 0582], “daytime data”, Table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, such that the method further comprises determining each temperature value of the plurality of temperature values based at least in part on receiving the physiological data, wherein the temperature data comprises continuous daytime temperature data, in view of the teachings of Pardey, as this would aid in improving the accuracy and speed of the temperature change detection by obtaining a representative temperature over the day time periods from the continuous temperature readings.
Regarding claim 7, Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, discloses the method of claim 1, wherein the physiological data further comprises heart rate data (“heart rate”, para. [0043, 0071], Table 3, fig. 5), the method further comprising: determining that received heart rate data exceeds a threshold heart rate for the user for at least a portion of the plurality of days (“pulse (heart) rate … value … physiological parameter from the first set… increase above a defined threshold”; “defined detection and threshold criteria relate to an increase of the respective physiological parameter”, para. [0068-0070, 0077]), wherein identifying the indication of the one or more anovulatory cycles in the time series is based at least in part on determining that the heart rate data exceeds the threshold heart rate for the user (“physiological parameters … heart rate … anovulatory cycle … different or variance … compared”, para. [0073-0074]).
Regarding claim 8, Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, discloses the method of claim 1, wherein the physiological data further comprises heart rate variability data (“heart rate variability”, para. [0073-0074], Table 3, fig. 7), the method further comprising: determining that the heart rate variability data falls below a threshold heart rate variability for the user for at least a portion of the plurality of days (“heart rate variability … variance or difference … smaller”; “defined detection and threshold criteria relate to a decrease of the respective physiological parameter”, para. [0073-0074, 0077]), wherein identifying the indication of the anovulatory cycle in the time series is based at least in part on determining that the heart rate variability data falls below the threshold heart rate variability for the user (“heart rate variability… anovulatory cycle … different or variance … compared”, para. [0073-0074]).
Regarding claim 10, Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, discloses the method of claim 1, further comprising identifying the indication of the one or more anovulatory cycles in the time series (“detect an anovulatory cycle … time windows W3 … W3’”, para. [0073-0074], Table 3, figs. 6 & 14). Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, does not expressly disclose the method further comprising: identifying a fertility window based at least in part on identifying the plurality of ovulatory cycles.
However, Pardey discloses identifying a fertility window based at least in part on identifying the plurality of ovulatory cycles (“identify … indication … window of fertility”, para. [0558-0559, 0595-0599], fig. 7b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, such that the method further comprises identifying a fertility window based at least in part on identifying the plurality of ovulatory cycles, in view of the teachings of Pardey, as this would aid in providing a prediction of the dates of the next fertile period for the user.
Regarding claim 11, Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, discloses the method of claim 1, further comprising: transmitting the message that indicates the indication of the one or more anovulatory cycles to the user device (“detected pregnancy related event … transmitted … mobile communication device 4”; “detect an ovulatory cycle”, para. [0063, 0074]), wherein the user device is associated with a clinician (“mobile communication device”; “anovulatory cycle is indicated to … healthcare provider”, para. [0063, 0074]).
Regarding claim 13, Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, discloses the method of claim 1, further comprising: causing the graphical user interface of the user device associated with the user (user interface of the wearable device 1, para. [0063]) to display a message associated with the plurality of ovulatory cycles (“event … graphical representation … display 16”; “anovulatory cycle is indicated to the female user”, para. [0063, 0074]).
Regarding claim 14, Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, discloses the method of claim 13. Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, does not expressly disclose wherein the message further comprises a time interval during which the plurality of ovulatory cycles occurred, a duration between a future ovulatory cycle and a previous ovulatory cycle, a time interval during which an ovulatory cycle is predicted to occur, a request to input symptoms associated with the plurality of ovulatory cycles, educational content associated with the plurality of ovulatory cycles, or a combination thereof.
However, Pardey discloses wherein the message (“message”, para. [0594, 0596]) further comprises a time interval during which the plurality of ovulatory cycles occurred, a duration between a future ovulatory cycle and a previous ovulatory cycle, a time interval during which an ovulatory cycle is predicted to occur, a request to input symptoms associated with the plurality of ovulatory cycles, educational content associated with the plurality of ovulatory cycles, or a combination thereof (“input”; “ovulation date”; “fertile period will be between <date>&<date>”; “ovulation window”, para. [0448, 0594, 0599-0597, 0644], figs. 5 & 7a-7b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, such that the message further comprises a time interval during which the plurality of ovulatory cycles occurred, a duration between a future ovulatory cycle and a previous ovulatory cycle, a time interval during which an ovulatory cycle is predicted to occur, a request to input symptoms associated with the plurality of ovulatory cycles, educational content associated with the plurality of ovulatory cycles, or a combination thereof, in view of the teachings of Pardey, as this would aid in providing the message indicating a prediction of the dates of the next fertile period for the user.
Regarding claim 15, Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, discloses the method of claim 1, further comprising: inputting the physiological data into a machine learning classifier, wherein identifying the indication of the one or more anovulatory cycles is based at least in part on inputting the physiological data into the machine learning classifier (“detection criteria … machine learning …. Classifiers”; “anovulatory cycle … detection criteria”, para. [0064, 0073-0074]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Stein in view of von Badinski, Pardey, and Kodama, as applied to claim 1 above, and further in view of Shoeb (US 10818390 B1).
Regarding claim 3, Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, discloses the method of claim 1, wherein identifying the indication of the one or more anovulatory cycles is based at least in part on determining that the deviation satisfies the threshold (“comparing … values … threshold … deviation or variance … smaller … identified as an anovulatory cycle”, para. [0070-0074]). Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, does not disclose determining that a dissimilarity matrix score satisfies a threshold based at least in part on comparing the plurality of temperature values of the plurality of ovulatory cycles with the current values of the plurality of temperature values, wherein identifying the indication of the one or more anovulatory cycles is based at least in part on determining that the dissimilarity matrix score satisfies the threshold.
However, Shoeb directed to computer-implemented techniques for discovering patterns indicative of similarity between measurements (col. 1 lines 5-10) discloses determining a dissimilarity matrix score satisfies a threshold based at least in part on comparing data (“similarity matrix … least similar … 0-1”; “similarity matrix … identifies at least one outlier data series … statistical rules … outlier threshold, col. 7 lines 37-49 & col. 10 lines 26-51, fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, such that the method further comprises determining that a dissimilarity matrix score satisfies a threshold based at least in part on comparing the plurality of temperature values of the plurality of ovulatory cycles with the current values of the plurality of temperature values, in view of the teachings of Shoeb, as this would aid in determining which data series are least similar and to identify at least one outlier data series for filtering of the data.
Furthermore, Stein, as modified by von Badinski, Pardey, Kodama, and Shoeb hereinabove, discloses wherein identifying the indication of the one or more anovulatory cycles is based at least in part on determining that the dissimilarity matrix score satisfies the threshold (Stein, “comparing … values … threshold … deviation or variance … smaller … identified as an anovulatory cycle”, para. [0070-0074] & Shoeb, col. 7 lines 37-49 & col. 10 lines 26-51).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Stein in view of von Badinski, Pardey, Kodama, as applied to claim 1 above, and further in view of Shinar (US 20160058429 A1) (herein Shinar 8429).
Regarding claim 4, Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, discloses the method of claim 1, and identifying one or more positive slopes, wherein the identified plurality of ovulatory cycles is associated with the one or more positive slopes (Pardey, as seen in figs. 6-8, “rise … onset of phase change … gradient above a threshold level … ovulation event”, para. [0600-0604]). Stein further discloses the physiological parameters include the heart rate variability and heart rate variability ratio and the defined detection and threshold criteria relate to an increase of the respective physiological parameter to indicate upcoming menstruation (para. [0073, 0077]).
Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, does not disclose identifying one or more positive slopes of spectral power for an ultradian frequency range based at least in part on receiving the physiological data, wherein the plurality of ovulatory cycles is associated with the one or more positive slopes of the spectral power.
However, Shinar 8429 discloses identifying spectral power for an ultradian frequency range based at least in part on receiving the physiological data (“days … late follicular phase is identified … power spectrum of the HRV signal … threshold … ratio of power-spectrum amplitudes … Hz component”, para. [0576], fig. 4), wherein the plurality of ovulatory cycles is associated with the spectral power (“identify the late follicular phase in response to a ratio of power-spectrum amplitudes”, para. [0576]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, such that the method further comprises identifying one or more positive slopes of spectral power for an ultradian frequency range based at least in part on receiving the physiological data, wherein the plurality of ovulatory cycles is associated with the one or more positive slopes of the spectral power, in view of the teachings of Shinar 8429, as this would aid in identifying upcoming menstruation and the late follicular phase in response to a ratio of power-spectrum amplitudes.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Stein in view of von Badinski, Pardey, and Kodama, as applied to claim 1 above, and further in view of Shinar (US 20150190087 A1) (herein Shinar 0087).
Regarding claim 9, Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, discloses the method of claim 1, wherein the physiological data further comprises respiratory rate data (breathing rate, para. [0068]), the method further comprising: determining that the respiratory rate data exceeds a threshold respiratory rate for the user for at least a portion of the plurality of days (“value … physiological parameter from the first set … increase above a predefined threshold”, para. [0068-0070]), wherein identifying the indication of the one or more anovulatory cycles in the time series is based at least in part on determining that the respiratory rate data exceeds the threshold respiratory rate for the user (“threshold … conceptive cycle … anovulatory … difference or variance … para. [0070, 0073-0074], Tables 3-4).
Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, does not expressly disclose wherein the physiological data further comprises continuous nighttime respiratory rate data.
However, Shinar 0087 discloses wherein the physiological data further comprises continuous nighttime respiratory rate data (“continuous measurement … respiration rate”; “breathing rate nighttime patterns … clinical event”; “breathing pattern … changes … menstrual cycle”, para. [0261, 0303, 0332], figs. 5-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, such that the physiological data further comprises continuous nighttime respiratory rate data, in view of the teachings of Shinar 0087, in order to detect clinical events based on the comparison of the baseline and breathing rate nighttime patterns.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Stein in view of von Badinski, Pardey, and Kodama, as applied to claim 1 above, and further in view of Lafon (US 20200000441 A1).
Regarding claim 12, Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, discloses the method of claim 1. Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, does not expressly disclose the method further comprising: causing the graphical user interface of the user device associated with the user to display ovulation tracking tags based at least in part on identifying the plurality of ovulatory cycles.
However, Lafon directed to a smart watch having a display screen comprising a user interface discloses causing the graphical user interface of the user device associated with the user to display ovulation tracking tags based at least in part on identifying the plurality of ovulatory cycles (“tag events … symptoms … cramps or water retention … output … graphs … menstrual cycle related symptoms”, para. [0036-0037, 0070], fig. 7). Lafon further discloses the interface enables a user to quickly view information for cycles that may have been atypical, for example, and see how that impacted various symptoms, such as whether an atypical menstrual cycle was associated with more headaches or cramping (para. 0070]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, such that the method further comprises causing the graphical user interface of the user device associated with the user to display ovulation tracking tags based at least in part on identifying the plurality of ovulatory cycles, in view of the teachings of Lafon, as this would aid in enabling a user to quickly view information for cycles that may have been atypical and see how that impacted various symptoms.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Stein in view of von Badinski, Pardey, and Kodama, as applied to claim 1 above, and further in view of Ellis (US 20180242850 A1)
Regarding claim 17, Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, discloses the method of claim 1. Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, does not expressly disclose wherein the wearable ring device collects the physiological data from the user based on arterial blood flow.
However, Ellis directed to a monitoring device discloses wherein the wearable device (“device … couple to an exterior of a user”, Abstract, fig. 3) collects the physiological data from the user based on arterial blood flow (“core body temperature measurements … arterial blood flow”; “temperature associated with arterial and/or venous blood”, para. [0021, 0036], figs. 1A & 3, see also para. [0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stein, as modified by von Badinski, Pardey, and Kodama hereinabove, such that the wearable ring device collects the physiological data from the user based on arterial blood flow, in view of the teachings of Ellis, in order to determine a core body temperature measurement associated with arterial blood and characterize a user condition based on the core body temperature measurement.
Conclusion
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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