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 .
Election/Restrictions
Applicant’s election of Group II (claims 13-20) in the reply filed 12/23/2025 is acknowledged. Because the applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claim 14 objected to because of the following informalities: In line 8, there is an extra space and comma between “signals,” and “and”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 13-20 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.
Regarding claim 13, the claim recites, “determining the presence, intensity, duration, or combination thereof, of a hot flash from the measurements determined in step (a).” It is unclear what is considered to be step (a) since it is not defined in the claim. It is recommended by the Examiner that the claim is amended to clearly define step (a). It is interpreted by the Examiner that step (a) includes everything from “determining a measure” to “over a total measurement period.”
Claim 13 recites the limitation "the presence, intensity, duration, or combination thereof…" in lines 1 and 2. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends amending to “a presence, intensity, duration…”.
Regarding claim 14, the claim recites “wherein step (a) comprises…”. It is unclear, based on the language of the claim, if this is the same step (a) from claim 13. If so, the claim has multiple step (a). The claim should be amended for clarity of which step is considered to be step (a).
Claims 15 and 16 are rejected for the same issue as claim 14 (see para. 6 above).
Claim 13 recites the limitation "the skin” in line 4. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends amending to “a skin of a subject.”
Claim 17-19 recite, “…wherein step (b) comprises…”. However, it is not clear what is considered to be step (a), and therefore, it is unclear if step (b) requires step (a) since it is not defined what step (a) is considered to be.
Claims 18 recites, “a decrease in capacitance from 0.Q1 to 0.08nF.” It is unclear what is meant by “0.Q1.” The examiner interprets this to mean “0.01.” Further, for the purpose of clarity, it is recommended to amend the claim as “a decrease within the range of 0.01 to 0.08nF.” Under the assumption that the Applicant meant 0.01, it is interpreted that the claim is within the range. However, if the Applicant means “a decrease from 0.1 to 0.08nF,” then it is unclear if the decrease is in that range or if it is a decrease from a starting value to an end value. For examination purposes, it will be interpreted as 0.01nF.
Claim 20 recites, “wherein step (a) comprises…and wherein step (b) comprises.” Step (a) and step (b) are not clearly defined in claim 13. Further, it is not clear if the measures for step (a) are those of claim 13 or the composite capacitance and skin temperature measurements recited in claim 20. The Examiner recommends clearly defining the steps of claim 13.
Further regarding claim 20, the claim recites “determining a start of a hot flash when the composite capacitance increases at the same time as the skin temperature decreases.” It is unclear, based on the language of the claim, what is defined as “determining a start of a hot flash.” It is ambiguous as to what steps are performed in the action of “determining” a start of a hot flash. It is likely that determining a start of a hot flash is labeling or indicating when a hot flash is occurring. However, this raises concerns as to why the skin temperature is decreasing during a hot flash. For examination purposes, it is interpreted that “determining a start of a hot flash” is synonymous with “identifying the start of a hot flash…” and will be interpreted as such. The Examiner recommends amending the claim for clarity regarding specific details regarding “determining the start of a hot flash.”
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 13-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards an abstract idea without significantly more.
Step 1 – Is the claim to a statutory category of intention?
Claim 13 recites a method. Therefore, the claim is directed to a statutory category of invention.
Step 2A, prong 1 – Does the claim recite a judicial exception?
Claim 13 recites: “determining the presence, intensity, duration, or a combination thereof, of a hot flash from the measures determined in step (a).” The recited limitation is an abstract idea mental process in that one of ordinary skill in the art, such as a physician, would be able to observe the measurements from claim 13 and make a determination of a presence, intensity, duration, or combination of a hot flash.
Step 2A prong 2 – Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claim 13 recites: “…determining a measure of a plurality of impedance, capacitance, AC resistance, phase, DC resistance, and temperature of the skin of a subject using a plurality of electrodes at a plurality of measurement times over a total measurement period.” The recited limitations are merely insignificant extra-solution activity data gathering. Obtaining various measurements from an electrode does not integrate the abstract idea into a practical application.
Step 2B – Do the additional elements add significantly more to the judicial exception?
Claim 13 recites: “…determining a measure of a plurality of impedance, capacitance, AC resistance, phase, DC resistance, and temperature of the skin of a subject using a plurality of electrodes at a plurality of measurement times over a total measurement period.” The recited limitations are merely insignificant extra-solution activity data gathering. Obtaining various measurements from an electrode does not add significantly more to the judicial exception.
Dependent claims
Claim 14 recites a method for proving generic structure for performing the methods of step 13 and does not integrate the abstract idea into a practical application or add significantly more to the abstract idea.
Claim 15 further limits the extra-solution activity data gathering.
Claim 16 recites generic computer activity (applying transitory signals).
Claims 17-19 recites limitations that further limits the abstract idea mental process (“determining the presence”).
Claim 20 further limits extra-solution activity data gathering and limits the abstract idea mental process (determining a start of a hot flash).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 13 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Stivoric (US 20170156594 A1).
Regarding claim 13, Stivoric teaches a method of determining the presence, intensity, duration, or a combination thereof, of a hot flash (para. [0166]: "This application has equal utility for use with menopausal women, in that these temperature readings may be utilized in detecting, characterizing, trending and predicting hot flashes and managing this change in life."), comprising: determining a measure of a plurality of impedance (para. [0139]: "It is to be specifically noted that a number of other types and categories of sensors may be utilized alone or in conjunction with those given above, including but not limited to…bio-impedance sensors."), capacitance (para. [0242]: " A proximity detector of this type utilizes an R/C oscillator constructed around the ambient capacitance of a copper plate. As the environment surrounding the plate changes, such as mounting the device on the human body or moving other objects closer/farther from the device armband, the capacitance of the plate changed leading to a change in the frequency of the oscillator."), AC resistance (para. [0139]: "bioimpedance sensor"; Resistance is related to impedance and could be derived from impedance), phase (para. [0248]: " Instantaneous changes in both the qualitative value and waveform characteristics are noted in the time period immediately subsequent to time T1 in the axillary ambient temperature output 903."; para. [0260]: "It should be noted that the shape of waveform 1003…"; Para. [0248] and [0260] demonstrate that the shape and characteristics of the waveform are taken.”; The shape and characteristics of a waveform are the same as the phase of a signal. The phase determines shape and characteristics.), DC resistance (para. [0139]; The current type doesn't change the fact that resistance would be measured with impedance and could be measured with the bio-impedance sensor), and temperature of the skin of a subject (para. [0033]: " Based on the multiple measurements taken with the Fraden device, the skin temperature of the individual is calculated."; para. [0168]: "A current temperature 350 is shown on the display and is the latest calculated temperature of the individual as determined from the detected measurements of module.") using a plurality of electrodes (para. [0046]: "The adhesive material may further support or contain all or additional sensors or electrodes for detection of the various parameters.") at a plurality of measurement times over a total measurement period (Fig. 23 shows temperature readings over time; Additionally, para. [0197] discloses the division of time periods (e.g. T0, T1)); determining the presence, intensity, duration, or a combination thereof, of a hot flash from the measures determined in step (a). (para. [0166]: "This application has equal utility for use with menopausal women, in that these temperature readings may be utilized in detecting, characterizing, trending and predicting hot flashes and managing this change in life."; para. [0254]: "Temperature sensing, as described above, may also provide information as to whether the wearer is too hot or too cold.").
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 13, 15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Connor (US 20150320588 A1, “Connor A”) in view of Connor (US 20190099009 A1, “Connor B”).
Regarding claim 13, Connor A teaches a method of determining the presence, intensity, duration, or a combination thereof, of a hot flash (Abstract: "…wearable technology with physiological sensors to predict when a person will have a hot flash…"), comprising: determining a measure of a plurality of impedance (para. [0127]: "an electrical conductivity, impedance, or resistance sensor."), AC resistance (para. [0127]: "an electrical conductivity, impedance, or resistance sensor."), phase (para. [0486]: "In an example, a system can analyze repeating electromagnetic patterns by analyzing their frequency of repetition, their frequency band or range of repetition, their recurring amplitude, their wave phase, and/or their waveform."), DC resistance (para. [0127]; The type of current doesn't change the capabilities of the resistance sensor to measure both AC or DC current), and temperature of the skin of a subject (para. [0396]: "wherein this sensor component collects data concerning the person's skin temperature and/or body temperature.") using a plurality of electrodes (a skin conductance sensor (see para. [0034]) would have electrodes since an electrode is defined as a conductor in which electricity enters or leaves. Additionally, there are multiple sensors used in the wearable device of Connor that conduct electricity; Thus, there are a plurality of electrodes.) at a plurality of measurement times (para. [0145]: "The left side of FIG. 1 shows this embodiment at a first point in time and the right side of FIG. 1 shows this embodiment at a second point in time.") over a total measurement period (The total measurement time would be the total time the wearable device is collecting data); determining the presence, intensity, duration, or a combination thereof, of a hot flash from the measures determined in step (a). (Abstract: "This invention is a sleep environment control system which uses wearable technology with physiological sensors to predict when a person will have a hot flash."). However, Connor A does not expressly teach measuring a capacitance.
Connor B, in the same field of endeavor of determining if an individual is experiencing hot flashes, discloses a method for using a wearable sensor to input controls for adjusting a mattress. Connor B discloses where skin capacitance is measured (para. [0558]: “In an example, a biometric sensor can be a wearable capacitance sensor to detect and/or predict a hot flash.”; para. [0559]: " a biometric sensor can collect data concerning changes in skin or other body tissue impedance or capacitance.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Connor A to further include a measurement of skin capacitance. As disclosed by Connor B, skin capacitance can be used to determine if someone is experiencing a hot flash. Since Connor B discloses measuring capacitance as a technique for predicting hot flash, one of ordinary skill in the art would recognize that measuring skin capacitance would yield successful outcomes in detecting the presence of a hot flash. Therefore, it would have been obvious to include measuring skin capacitance, as disclosed by Connor B, in the method of claim 13, as disclosed by Connor A.
Regarding claim 15, Connor A, in combination with Connor B, discloses the method of claim 13 (see above). Connor A further discloses wherein step (a) comprises determining a composite capacitance, a combined phase, or a combination thereof. (para. [0558]: "… a biometric sensor can be a capacitance sensor…"; para. [0559]: "…a biometric sensor can collect data concerning changes in skin or other body tissue impedance or capacitance…).
Regarding claim 20, Connor A, in combination with Connor B, discloses the method of claim 13 (see above). Further, Connor B further discloses determining a composite capacitance (para. [0559]: “In an example, a biometric sensor can collect data concerning changes in skin or other body tissue impedance or capacitance in order to detect and/or predict hot flashes.”) and a skin temperature (para. [0381]: “wherein this sensor component collects data concerning the person's skin temperature and/or body temperature”). The Examiner notes that the step of “determining a start of a hot flash” is interpreted as when a hot flash begins (since the skin temperature is not decreasing during a hot flash). Therefore, including this step in the method does not distinguish the claimed method from the prior art since the method of Connor B discloses using skin capacitance and temperature measurements to determine a hot flash. Further, since the claim is directed towards effects of a hot flash, and Connor A and B both disclose methods of using skin capacitance and temperature to determine a hot flash, Connor A and B would have the same effect of increased capacitance and decreased temperature at the start of a hot flash. Increased capacitance and decreased temperature are characteristics of the start of a hot flash, and labeling a start of a hot flash by identifiable characteristics does not distinguish the claimed invention from the prior art since the hot flash of Connor B would also have this same characteristic.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include the method steps of determining composite capacitance and skin temperature measurements for the determination of a hot flash, as disclosed by Connor B with the method of claim 13, as disclosed by the combination of Connor A and Connor B. Further, one of ordinary skill in the art would recognize that the additional limitation of determining a start of a hot flash when the composite capacitance increases at the same time that skin temperature decreases would have been obvious upon routine experimentation. Connor B discloses using both a skin temperature sensor and skin capacitance sensor to determine a hot flash. One of ordinary skill would recognize, after reading the disclosure of Connor B, that it would have been obvious to experiment with both sensors. One of ordinary skill would be able to determine that hot flashes start when temperature decreases and capacitance increases by comparing data. As interpreted by the Examiner, the step of “determining a start of a hot flash” is merely a definition given to when a hot flash begins (obviously the skin temperature isn’t decreasing during a hot flash).
Claims 14 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Connor (US 20150320588 A1, “Connor A”), Connor (US 20190099009 A1, “Connor B”), and Taylor (US 20220104766 A1, “Taylor”).
Regarding claim 14, the combination of Connor A and Connor B disclose the method of claim 13 (see above). Connor A further discloses wherein step (a) comprises providing an apparatus comprising: a control system configured to apply electrical signals (para. [0180]: "In an example, electromagnetic energy sensor 1002 can measure the conductivity, resistance, and/or impedance of electrical energy flow through tissue in the person's wrist, hand, and/or arm."; Impedance sensors work by applying a relatively low current to the skin of a subject and then recording the signal.) to the interdigitated sensor and collect signals from the interdigitated sensor (para. [0035]: "wherein this wearable sensor collects data concerning the person's current body temperature and/or data used to predict the person's future body temperature."); an analysis system configured to accept signals from the interdigitated sensor (para. [0498] mentions performing analysis from the sensor data: “…multivariate analysis of data from two or more different types of sensors can detect and/or predict hot flashes…”), and to determine the presence, intensity, duration, or a combination thereof, of a hot flash from the interdigitated sensor signals (para. [0498]: "this system can comprise two or more different types of wearable sensors. In an example, multivariate analysis of data from two or more different types of sensors can detect and/or predict hot flashes with a higher level of accuracy than data from only one type of wearable sensor."), and using the apparatus to determine a measure of a plurality of impedance (para. [0127]: "an electrical conductivity, impedance, or resistance sensor."), AC resistance (para. [0127]: "an electrical conductivity, impedance, or resistance sensor."), phase (para. [0486]: "In an example, a system can analyze repeating electromagnetic patterns by analyzing their frequency of repetition, their frequency band or range of repetition, their recurring amplitude, their wave phase, and/or their waveform."), DC resistance (para. [0127]; The type of current doesn't change the capabilities of the resistance sensor to measure both AC or DC current), and temperature of the skin of a subject (para. [0396]: "wherein this sensor component collects data concerning the person's skin temperature and/or body temperature.") using a plurality of electrodes (a skin conductance sensor (see para. [0034]) would have electrodes since an electrode is defined as a conductor in which electricity enters or leaves. Additionally, there are multiple sensors used in the wearable device of Connor that conduct electricity; Thus, there are a plurality of electrodes.) at a plurality of measurement times (para. [0145]: "The left side of FIG. 1 shows this embodiment at a first point in time and the right side of FIG. 1 shows this embodiment at a second point in time.") over a total measurement period (The total measurement time would be the total time the wearable device is collecting data). However, Connor A does not disclose where the method uses an interdigitated sensor, or where capacitance is measured.
Connor B discloses where skin capacitance is measured (para. [0558]: “In an example, a biometric sensor can be a wearable capacitance sensor to detect and/or predict a hot flash.”; para. [0559]: " a biometric sensor can collect data concerning changes in skin or other body tissue impedance or capacitance.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Connor A to further include a measurement of skin capacitance. As disclosed by Connor B, skin capacitance can be used to determine if someone is experiencing a hot flash. Since Connor B discloses measuring capacitance as a technique for predicting hot flash, one of ordinary skill in the art would recognize that measuring skin capacitance would yield successful outcomes in detecting the presence of a hot flash. Therefore, it would have been obvious to include measuring skin capacitance, as disclosed by Connor B, in the method of claim 13, as disclosed by Connor A. However, the combination of Connor A and Connor B does not disclose an interdigitated sensor.
Taylor, in the same field of endeavor of bio-sensors, discloses a device and method for measuring a skin capacitance of an individual. Taylor discloses using an interdigitated sensor for measuring skin capacitance (Fig. 3; para. [0040]: "an interdigitated portion for measuring capacitance of skin of the subject, said interdigitated portion having at least two separate electrical contacts.")
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include an interdigitated sensor, as disclosed by Taylor, as the sensor type used for the method of claim 13, as disclosed by the Connor A and B combination. One of ordinary skill in the art would recognize that, by including interdigitated sensors, the contacts of the sensor would be able to measure skin capacitance, as disclosed by Taylor. One of ordinary skill would expect the interdigitated to successfully measure capacitance. Further, it would be an obvious improvement to include an interdigitated sensor since the interdigitated portion spacing could be varied in contact while in contact with the user’s skin (see para. [0168] of Taylor). This would allow the skin contacts to be optimized for efficient measurement of capacitance, which would be a desirable improvement of the method of claim 13.
Regarding claims 17, 18, and 19, Connor A, in combination with Connor B, discloses the method of claim 13 (see above). Further, Connor B discloses using signals from a capacitance sensor to determine a hot flash (para. [0558]: "In an example, a biometric sensor can be a wearable capacitance sensor to detect and/or predict a hot flash."). However, neither reference discloses using an interdigitated sensor, or a decrease in capacitance within a specific range.
Taylor discloses using an interdigitated sensor for measuring skin capacitance (Fig. 3; para. [0040]: "an interdigitated portion for measuring capacitance of skin of the subject, said interdigitated portion having at least two separate electrical contacts.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include an interdigitated sensor, as disclosed by Taylor, as the sensor type used for the method of claim 13, as disclosed by the Connor A and B combination. One of ordinary skill in the art would recognize that, by including interdigitated sensors, the contacts of the sensor would be able to measure skin capacitance, as disclosed by Taylor. One of ordinary skill would expect the interdigitated to successfully measure capacitance. Further, it would be an obvious improvement to include an interdigitated sensor since the interdigitated portion spacing could be varied in contact while in contact with the user’s skin (see para. [0168] of Taylor). This would allow the skin contacts to be optimized for efficient measurement of capacitance, which would be a desirable improvement of the method of claim 13. Additionally, it would have been an obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include the ranges of decreasing capacitance. One of ordinary skill in the art would recognize that it would have been obvious to arrive at the claimed ranges through routine experimentation/optimization. Citing MPEP 2144.05 (II), In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955): “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." It would have been obvious to try measuring capacitance during hot flashes to arrive at the specific ranges of decreases in capacitance and time durations until reaching an optimal range for determine hot flashes. Therefore, since Connor B discloses using skin capacitance to determine hot flashes, it would have been obvious to include this in the method of claim 13, which is also concerned with predicting hot flashes.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Connor (US 20150320588 A1, “Connor A”), Connor (US 20190099009 A1, “Connor B”), and Bora et al. ("Estimation of skin impedance models with experimental data and a proposed model for human skin impedance"; IET Systems Biology; Published September 15, 2020).
Regarding claim 16, Connor A and B disclose the method of claim 13 (see above). However, neither reference discloses wherein step (a) comprises applying an electrical signal to an interdigitated sensor, wherein the electrical signal comprises an alternating voltage at a frequency from 5kHz to 95kHz.
Bora, in the same field of endeavor of biosensors, discloses experimenting with skin impedance. Bora discloses applying an electrical signal to an interdigitated sensor (2.1.2, Test Procedure: "Literature has mentioned different shape for electrodes for measurement of skin impedance. The most notable shapes are rectangular, circular, spiral, interdigital or a concentric ring."), wherein the electrical signal comprises an alternating voltage (2.1.3., Evaluation method: "When biological tissues are subjected to alternating current, they exhibit frequency‐dependent impedance characteristics.") at a frequency from 5kHz to 95kHz (“2.1.3, Evaluation method: "It is known that most bioimpedance measurement should be done between 100 Hz and 10 MHz [36 ]. However, in this work, the working frequency range has been set in the range of 2–200 kHz.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to further include applying an electrical signal to an interdigitated sensor, as disclosed by Bora, with the method of claim 13. Bora discloses that interdigitated electrodes are known to be used in measurement devices for skin impedance. One of ordinary skill in the art would recognize that using an interdigitated sensor would yield reasonable predictability of success. Additionally, one of ordinary skill would also recognize that it would have been obvious to apply an alternating current to a sensor since there are only two current types, alternating and direct. It would have been obvious to try using both current types to determine which would be most suitable in the method of measuring skin impedance. Lastly, since Bora discloses applying an electrical signal to a skin sensor at alternating frequency ranges (see Bora section 2.1.3), it would have been obvious to arrive at the claimed ranges through routine experimentation/optimization. Citing MPEP 2144.05 (II), In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955): “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." It would have been obvious to try a range frequencies in the workable frequency range, as disclosed by Bora, to arrive at an optimal frequency for measuring skin impedance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OWEN LEWIS MARSH whose telephone number is (571)272-8584. The examiner can normally be reached 7:30am – 5pm (M-Th) and 8am – noon (F).
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/O.L.M./Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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