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 .
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites the steps determining a time series of a plurality of pulse wave velocity, identifying a baseline value and detecting an indication of one or more conditions of the user.
The limitations of determining a time series of a plurality of pulse wave velocity, identifying a baseline value and detecting an indication of one or more conditions of the user, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “one or more memories”; “one or more processors”; and outputting digital data (all of which include or involve generic computer components), the claims are direct to concepts relating to organizing information in a way that can be performed mentally or analogous to human mental work and nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the processor, memory and output language, “determining” “identifying” and “detecting” in the context of this claim encompasses the user manually calculating pulse wave velocity visually identifying or calculating a baseline value and comparing the trends to detect an indication of a condition. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of an output or graphical user interface. This generically recited element only performs insignificant extra-solutional activity, specifically post-solutional display activity. Additionally, the processor and memories are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Similarly the dependent claims do not include additional elements that amount to significantly more. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept and well-understood, routine and conventional activity is not sufficient to amount to significantly more than the abstract idea itself. The claim is not patent eligible.
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 1-20 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. The claims recite the baseline value associated with a blood pressure, an arterial stiffness or both, of the user. It is unclear if this is reciting a step of associating or just stating that the baseline value is indicative of blood pressure and arterial stiffness. The claim also recites a second variation but does not specify what the variation is. It is assumed it is another variation in the one or more pulse wave velocity values.
Claims 3-7 and 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. It is unclear if the variations are determined to correspond to a blood pressure or arterial stiffness. It is also unclear if a variation could be one corresponding to blood pressure and the other arterial stiffness and how that difference or detection is made.
Claims 9-13 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. It is unclear when the baselines for the other measured parameters are determined or if they are determined and not preset.
Claim 14 is 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. It is unclear how a likelihood is estimated from an indication of the one or more conditions. The specification, at ¶133,169, only repeats this particular limitation with out any specifics of the determination. It is unclear if the likelihood is determined from the pulse wave velocity readings or from the indication/detection of the condition.
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.
Claim(s) 1-11 and 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Euliano et al. US 2021/0161402.
Regarding claims 1 and 18, Euliano discloses a method comprising:
receiving physiological data associated with a user from a wearable device, the physiological data comprising pulse wave velocity data ([¶15] the device has sensors for PPG and ECG which contains pulse wave velocity data);
determining a time series of a plurality of pulse wave velocity values taken over a plurality of days based at least in part on the pulse wave velocity data ([¶42,43] a processor and memory [¶76] pulse transit time is determined. Pulse wave velocity is not specifically disclosed but it would have been obvious to one of ordinary skill in the art to determine pulse wave velocity from the PTT if the distance traveled is known);
identifying a baseline value for the user based at least in part on determining the time series of the plurality of pulse wave velocity values, the baseline value associated with a blood pressure, an arterial stiffness, or both, of the user ([¶76,110,133] changes in PTT are determined and trends are determined so the baselines are the point the trend or change is compared to);
detecting an indication of one or more conditions of the user during a pregnancy of the user based at least in part on a first variation in one or more additional pulse wave velocity values from the baseline value, wherein the indication of the one or more conditions is detected based on a comparison of the first variation with a second variation associated with a current stage of the pregnancy of the user ([¶51,69,133] the variations and trends are used to determine preeclampsia); and
outputting a signal to cause a graphical user interface of a user device to display a message corresponding to the detected indication of the one or more conditions ([¶52] recommendations and treatments are displayed).
Regarding claims 2 and 19, Euliano discloses determining a first time series of a first plurality of pulse wave velocity values taken over a first plurality of days based at least in part on the pulse wave velocity data, the first plurality of days corresponding to a period when the user is not pregnant, wherein identifying the baseline value is based at least in part on determining the first time series ([¶76,110,133] changes in PTT are determined and trends are determined. [¶103] the data can be taken before during and after pregnancy); and
determining a second time series of a second plurality of pulse wave velocity values taken over a second plurality of days based at least in part on the pulse wave velocity data, the second plurality of days corresponding to the current stage of the pregnancy, wherein detecting the indication of the one or more conditions is based at least in part on determining the second time series ([¶76,110,133] changes in PTT are determined and trends are determined. [¶103] the data can be taken before during and after pregnancy).
Regarding claims 3 and 20, Euliano discloses the first variation corresponds to a first decrease in the blood pressure, the arterial stiffness, or both, during at least a portion of the time series that is less than a second decrease in the blood pressure, the arterial stiffness, or both, during at least the portion of the time series, the second decrease corresponding to the second variation ([¶76,110,133] changes in the trends are used to determine the condition including increases and decreases across the monitoring periods).
Regarding claim 4, Euliano discloses the first variation corresponds to an increase in the blood pressure, the arterial stiffness, or both, during at least a portion of the time series, and the second variation corresponds to a decrease in the blood pressure, the arterial stiffness, or both, during at least the portion of the time series ([¶76,110,133] changes in the trends are used to determine the condition including increases and decreases across the monitoring periods).
Regarding claim 5, Euliano discloses the first variation corresponds to a first increase in the blood pressure, the arterial stiffness, or both, during at least a portion of the time series that is less than a second increase in the blood pressure, the arterial stiffness, or both, during at least the portion of the time series, the second increase corresponding to the second variation ([¶76,110,133] changes in the trends are used to determine the condition including increases and decreases across the monitoring periods).
Regarding claim 6, Euliano discloses the current stage of the pregnancy corresponds to a post-partum period ([¶103] the data can be taken before, during and after pregnancy).
Regarding claim 7, Euliano discloses the first variation corresponds to a decrease in the blood pressure, the arterial stiffness, or both, during at least a portion of the time series, and the second variation corresponds to an increase in the blood pressure, the arterial stiffness, or both, during at least the portion of the time series ([¶76,110,133] changes in the trends are used to determine the condition including increases and decreases across the monitoring periods).
Regarding claim 8, Euliano discloses receiving an indication of the current stage of the pregnancy of the user, wherein detecting the indication of the one or more conditions is based at least in part on receiving the indication of the current stage of the pregnancy ([¶150] the device uses an indication of the current state of pregnancy in its determinations).
Regarding claim 9, Euliano discloses determining body temperature data from the physiological data; and determining that the body temperature data deviates from a baseline body temperature for the user for at least a portion of the plurality of days, wherein detecting the indication of the one or more conditions is based at least in part on the body temperature data deviating from the baseline body temperature ([¶137] body temperature changes are analyzed in the determination as well).
Regarding claim 10, Euliano discloses determining heart rate data from the physiological data; and determining that the heart rate data exceeds a baseline heart rate for the user for at least a portion of the plurality of days, wherein detecting the indication of the one or more conditions is based at least in part on the heart rate data exceeding the baseline heart rate ([¶76] heart rate trend data is analyzed in the determinations).
Regarding claim 11, Euliano discloses determining heart rate variability data from the physiological data; and determining that the heart rate variability data is below a baseline heart rate variability for the user for at least a portion of the plurality of days, wherein detecting the indication of the one or more conditions is based at least in part on the heart rate variability data being below the baseline heart rate variability ([¶83,84,127] heart rate variability is monitored and tracked as part of the determination).
Regarding claim 13, Euliano discloses determining blood oxygen saturation data from the physiological data; and determining that the blood oxygen saturation data exceeds a baseline blood oxygen saturation for the user for at least a portion of the plurality of days, wherein detecting the indication of the one or more conditions is based at least in part on the blood oxygen saturation data exceeding the baseline blood oxygen saturation ([¶53,97] oxygen saturation is also analyzed in the determination of preeclampsia).
Regarding claim 14, Euliano discloses estimating a likelihood of the one or more conditions of the user based at least in part on the indication of the one or more conditions, wherein outputting the signal is based at least in part on the likelihood exceeding a threshold value ([¶109,115] the classifier can determine the likelihood of preeclampsia).
Regarding claim 15, Euliano discloses inputting, into a machine learning classifier, the physiological data comprising the pulse wave velocity data, wherein detecting the indication of the one or more conditions of the user during the pregnancy of the user is based at least in part on inputting the physiological data into the machine learning classifier ([¶69,109] machine learning is used to create the classifier that uses all the collected physiologic signals).
Regarding claim 16, Euliano discloses the message displays a time during which the one or more conditions occurred, a time interval during which the one or more conditions are predicted to occur, a request to input symptoms associated with the one or more conditions, educational content associated with the one or more conditions, an adjusted set of sleep targets, an adjusted set of activity targets, recommendations to improve symptoms associated with the one or more conditions, a recommendation to consult a clinician, or a combination thereof ([¶119] the device can output treatment recommendation to improve symptoms and notify when a clinician is needed).
Regarding claim 17, Euliano discloses the one or more conditions comprise preeclampsia, eclampsia, gestational diabetes, hypertension, hypotension, fever, cardiometabolic disorders, infections, or a combination thereof ([¶42,43] the device determines preeclampsia).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Euliano et al. US 2021/0161402 in view of Oura WO 2022/212758.
Regarding claim 12, Euliano does not specifically disclose determining respiratory rate data from the physiological data; and determining that the respiratory rate data exceeds a baseline respiratory rate for the user for at least a portion of the plurality of days, wherein detecting the indication of the one or more conditions is based at least in part on the respiratory rate data exceeding the baseline respiratory rate. Oura teaches a similar physiological monitoring device that track respiration in relation to pregnancy and preeclampsia determinations ([¶109,111]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Euliano with the teachings of Oura in order to provide additional parameters for pregnancy complication tracking and determination ([¶109]).
Conclusion
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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