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 .
Specification
The disclosure is objected to because of the following informalities:
In [0094], line 1, “step 414” should be --step 412-- to be consistent with the drawings.
In [0127], line 9, “a discovery score” should be --a recovery score-- to be consistent with the drawings.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 900 (see [0184]). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
MPEP 2106 outlines a two-part analysis for Subject Matter Eligibility as shown in the chart below.
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Step 1, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101 defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter.
Step 2, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception.
Step 2A is a two-prong inquiry, as shown in the chart below.
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Prong One asks does the claim recite an abstract idea, law of nature, or natural phenomenon? In Prong One examiners evaluate whether the claim recites a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. If the claim recites a judicial exception (i.e., an abstract idea enumerated in MPEP § 2106.04(a), a law of nature, or a natural phenomenon), the claim requires further analysis in Prong Two. If the claim does not recite a judicial exception (a law of nature, natural phenomenon, or abstract idea), then the claim cannot be directed to a judicial exception (Step 2A: NO), and thus the claim is eligible at Pathway B without further analysis. Abstract ideas can be grouped as, e.g., mathematical concepts, certain methods of organizing human activity, and mental processes.
Prong Two asks does the claim recite additional elements that integrate the judicial exception into a practical application? If the additional elements in the claim integrate the recited exception into a practical application of the exception, then the claim is not directed to the judicial exception (Step 2A: NO) and thus is eligible at Pathway B. This concludes the eligibility analysis. If, however, the additional elements do not integrate the exception into a practical application, then the claim is directed to the recited judicial exception (Step 2A: YES), and requires further analysis under Step 2B.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding claim 1, Step 1: Is the claim to a process, machine, manufacture or composition of matter? Yes (apparatus).
Step 2A: Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)? Yes (see analysis below).
Prong one: Whether the claim recites a judicial exception? (Yes). The claim recites:
1. A computer program product for operating a wearable, continuous physiological monitoring system, the computer program product comprising computer executable code embodied in a non-transitory computer readable medium that, when executing on the wearable, continuous physiological monitoring system, performs the steps of:
storing a window of time domain data for a physiological signal, the window including a series of samples of the physiological signal;
detecting a first peak and a second peak in the physiological signal using a time domain process on the series of samples, wherein the time domain process includes a first state machine configured to sequentially process the series of samples and identify the first peak and the second peak in the series of samples;
evaluating a quality of the time domain data in the window indicative of how well a time domain shape associated with a peak shape matches an expected peak shape for the physiological signal, wherein evaluating a quality of the time domain data includes identifying the peak shape by identifying a local minimum located between a first local maximum and a second local maximum with a second state machine;
locally refining a peak position of each of the first peak and the second peak, wherein locally refining the peak position includes interpolating a location of a maximum for a number of sequential samples within the time domain data having similar magnitudes; and
when the quality exceeds a predetermined threshold, conditionally calculating a physiological interval for the window of time domain data wherein the physiological interval is based on a time between the first peak and the second peak and storing a value based on the quality as a quality flag for the window of time domain data.
The claim is directed to an abstract idea because the above bold-faced limitations are directed to mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations; and/or mental processes – concepts performed in the human mind (or with a pen and paper).
Prong two: Whether the claim recites additional elements that integrate the exception into a practical application of that exception? (No). The claim recites additional elements as underlined in the claim above. However, the storing step is recited at a high level of generality to collect the data for the abstract idea, which is an insignificant extra-solution activity. See MPEP 2106.05(g). The computer program product (an apparatus) is to invoke a generic computer for its computing power to facilitate the application of the abstract idea. See MPEP 2106.05(f). The wearable, continuous physiological monitoring system is recited at a high level of generality to indicate the data source or environment, which is a field of use. See MPEP 2106.05(h). Accordingly, the additional elements are insufficient to integrate the abstract idea into a practical application of the abstract idea.
Step 2B: Does the claim recite additional elements (other than the judicial exception) that amount to significantly more than the judicial exception? No (see analysis below).
The claim does not include additional elements that are sufficient to make the claim significantly more than the judicial exception. As discussed with respect to Step 2A Prong Two above, the additional element(s) in the claim are an insignificant extra-solution activity, to invoke a generic computer for its computing power to facilitate the application of the abstract idea, and/or to indicate the data source or environment, which is a field of use. Also, it is routine and conventional to invoke a computer for data processing. See MPEP 2106.05(d). Considered as a whole, the claim does not amount to significantly more than the abstract idea.
Claim 4 is similarly rejected by analogy to claim 1 regarding the abstract idea. Note that the storing step is an insignificant extra-solution activity. The rest of the steps are directed to mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations; and/or mental processes – concepts performed in the human mind (or with a pen and paper).
Claim 13 is similarly rejected by analogy to claims 1 and 4. Note that the claim recites an abstract idea similar to claim 4. The claim recites a wearable housing, one or more sensors in the wearable housing for capturing physiological data; and a processor in the wearable housing, similar to claim 1. They are recited at a high level of generality that they do not sufficiently limit the structure of the housing, the structure of sensors, and the type of sensed data (physiological data is a very broad term that covers so many different types of data).
Dependent claims 2, 3, 5-12 and 14-20 when analyzed as a whole respectively are held to be patent ineligible under 35 U.S.C. 101 because they either extend (or add more details to) the abstract idea or the additional recited limitation(s) (if any) fail(s) to establish that the claim(s) is/are not directed to an abstract idea, as discussed below: there is no additional element(s) in the dependent claims that sufficiently integrates the abstract idea into a practical application of, or makes the claims significantly more than, the judicial exception (abstract idea). The additional element(s) (if any) are mere instructions to apply an except, field of use, and/or insignificant extra-solution activities (applied to Step 2A_Prong Two and Step 2B; see MPEP 2016.05(f)-(h)) and/or well-understood, routine, or conventional (applied to Step 2B; see MPEP 2106.05(d)) to facilitate the application of the abstract idea.
Claim Rejections - 35 USC § 102
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 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.
Claims 4 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by LEE et al. (WO 2010140746 A1; machine translation provided; hereinafter “LEE”).
Regarding claim 4, Lee teaches a method comprising:
storing a window of time domain data for a physiological signal, the window including a series of samples of the physiological signal (i.e., “an electrocardiogram signal is acquired in a portable electrocardiogram device having a low sample rate”; see translation p. 1, lower section; “The experiment time was 5 minutes each”; see translation p. 6, ¶ 4);
detecting a first peak and a second peak in the physiological signal using a time domain process on the series of samples (i.e., “The ECG compensator 120 selects a predetermined number of consecutive QRS sections (ie, R waveforms) from the ECG waveform detected by the ECG detector 110 in a predetermined number (eg, 10)… the ECG compensator 120 checks the R peak of the QRS section using the morphological characteristics of the QRS complex in the ECG waveform as described above”; see translation p. 5, upper section);
locally refining a peak position of each of the first peak and the second peak (i.e., “a calculating step of calculating an interpolated value of relevant R-peaks using the regression curve corresponding to the rising section and the falling section”; see Abstract); and
calculating a physiological interval based on a time between the first peak and the second peak (i.e., “an acquiring step of acquiring an electrocardiogram signal using the interpolated value”; see Abstract; “By acquiring an error-corrected ECG signal (that is, RR interval), it is possible to accurately extract and provide HRV (Heart Rate Variability), PTT (Pulse Transit Time), and the like”; see translation p. 2, lower section).
Regarding claim 9, LEE further teaches
wherein locally refining the peak position includes estimating a value of a maximum at a location for the maximum between two sequential samples within the time domain data (i.e., “a calculating step of calculating an interpolated value of relevant R-peaks using the regression curve corresponding to the rising section and the falling section”; see Abstract).
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 10, 11, 13, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over LEE.
Regarding claim 10, LEE further teaches:
wherein the time domain process includes a state machine configured to (i.e., “measuring a predetermined number of consecutive R waveforms”; see translation p. 3, upper section).
LEE does not explicitly disclose (see only the underlined):
wherein the time domain process includes a state machine configured to sequentially process the series of samples and identify the first peak and the second peak in the series of samples.
However, it is well-known to process data according to their sequences. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify LEE, such that the time domain process includes a state machine configured to sequentially process the series of samples and identify the first peak and the second peak in the series of samples, as claimed. The rationale would be to help orderly detect the R waves.
Regarding claim 11, LEE further teaches: wherein the state machine is further configured to perform the steps of:
identifying a first pulse candidate, wherein the first pulse candidate is a heart rate signal (i.e., “The ECG compensator 120 selects a predetermined number of consecutive QRS sections (ie, R waveforms) from the ECG waveform detected by the ECG detector 110 in a predetermined number (eg, 10)… the ECG compensator 120 checks the R peak of the QRS section using the morphological characteristics of the QRS complex in the ECG waveform as described above”; see translation p. 5, upper section);
conditionally labelling (i.e., selecting) the first pulse candidate as the first peak when the first pulse candidate is determined to be an R-pulse (i.e., “The ECG compensator 120 selects a predetermined number of consecutive QRS sections (ie, R waveforms) from the ECG waveform detected by the ECG detector 110 in a predetermined number (eg, 10)… the ECG compensator 120 checks the R peak of the QRS section using the morphological characteristics of the QRS complex in the ECG waveform as described above”; see translation p. 5, upper section);
identifying a second pulse candidate, wherein the second pulse candidate is a heart rate signal (i.e., “The ECG compensator 120 selects a predetermined number of consecutive QRS sections (ie, R waveforms) from the ECG waveform detected by the ECG detector 110 in a predetermined number (eg, 10)… the ECG compensator 120 checks the R peak of the QRS section using the morphological characteristics of the QRS complex in the ECG waveform as described above”; see translation p. 5, upper section); and
conditionally labelling (i.e., selecting) the second pulse candidate as the second peak when the second pulse candidate is determined to be an R-pulse (i.e., “The ECG compensator 120 selects a predetermined number of consecutive QRS sections (ie, R waveforms) from the ECG waveform detected by the ECG detector 110 in a predetermined number (eg, 10)… the ECG compensator 120 checks the R peak of the QRS section using the morphological characteristics of the QRS complex in the ECG waveform as described above”; see translation p. 5, upper section).
Regarding claim 13, the claim recites the same substantive limitations as claim 4 and is rejected by applying the same teachings, except for the limitations underlined below:
A system comprising:
a wearable housing;
one or more sensors in the wearable housing for capturing physiological data; and
a processor in the wearable housing, the processor configured by computer executable code to perform the steps of storing a window of time domain data for a physiological signal, the window including a series of samples of the physiological signal, detecting a first peak and a second peak in the physiological signal using a time domain process on the series of samples, locally refining a peak position of each of the first peak and the second peak, and calculating a physiological interval based on a time between the first peak and the second peak.
However, LEE further teaches:
a portable electrocardiogram device (see Abstract and translation p. 4, middle section) having a processing (see translation p. 3, ¶ 3) and an electrocardiogram sensor (see translation p. 4, middle section).
It is well-known to design a portable device as a wearable device (see LEE translation p. 4 describing the device being small and portable). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify LEE as a system comprising a wearable housing; one or more sensors in the wearable housing for capturing physiological data; and a processor in the wearable housing, the processor configured by computer executable code to perform the analogous method, as claimed. The rationale would be to allow the device to be portable while operating on a subject or patient.
Regarding claim 17, the claim recites the same substantive further limitations as claim 9 and is rejected by applying the same teachings.
Regarding claim 18, the claim recites the same substantive further limitations as claim 10 and is rejected by applying the same teachings.
Regarding claim 19, the claim recites the same substantive further limitations as claim 11 and is rejected by applying the same teachings.
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over LEE in view of JOHN et al. (US 20210401332 A1; hereinafter “JOHN”).
Regarding claim 5, LEE further teaches:
evaluating a quality of the time domain data in the window indicative of how well a time domain shape associated with a peak shape matches an expected peak shape for the physiological signal (i.e., “The ECG correction unit 120 checks the position of the R waveform from the morphological characteristics of the QRS complex of the EKG waveform”; see translation p. 4, middle section);
conditionally calculating the physiological interval when the quality exceeds a predetermined threshold (i.e., this is inherent or obvious because an R-wave needs to be recognized based on meeting a threshold of the morphological characteristics in order to be used for calculating the RR interval); and
LEE does not explicitly disclose:
storing a value based on the quality as a quality flag for the window.
But JOHN teaches:
providing a signal quality flag (i.e., “This part of the sensor system includes “signal quality flags”, generated via signal processing, to indicate the quality of the biometric data and to inform the program to exclude low quality and erroneous data”; see [0232]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify LEE in view of JOHN by storing a value based on the quality as a quality flag for the window, as claimed. The rationale would be to provide an indication for the quality of the data.
Regarding claim 14, the claim recites the same substantive further limitations as claim 5 and is rejected by applying the same teachings.
Claims 6, 7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over LEE in view of JOHN and Koivisto et al. (US 20180256040 A1; hereinafter “Koivisto”).
Regarding claim 6, the prior art applied to the preceding linking claim(s) teaches the features of the linking claim(s).
LEE does not explicitly disclose:
wherein evaluating a quality of the time domain data includes identifying the peak shape by identifying a local minimum located between a first local maximum and a second local maximum with a state machine.
But Koivisto teaches:
confirming an R-wave by identifying the peak shape by identifying a local minimum (i.e., S wave) located between a first local maximum (a first R wave) and a second local maximum (i.e., a second R wave) with a state machine (i.e., “an S wave is detected on the basis of the third signal and indicated for confirming the R wave detection”; see [0011]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify LEE in view of JOHN, further in view of Koivisto, such that evaluating a quality of the time domain data includes identifying the peak shape by identifying a local minimum located between a first local maximum and a second local maximum with a state machine, as claimed. The rationale would be to help confirming a real R wave.
Regarding claim 7, as a result of modification applied to claim 5 above, LEE in view of JOHN and Koivisto further teaches:
wherein the physiological signal is a heart rate signal (i.e., “electrocardiogram signal”; see LEE Abstract), and wherein evaluating the quality of the time domain data further includes conditionally labelling the quality of the time domain data as low-RR-quality when the difference in amplitudes of the first local maximum and the second local maximum are within a predetermined threshold (see discussion of claim 5 above).
Regarding claim 15, the claim recites the same substantive further limitations as claim 6 and is rejected by applying the same teachings.
Claims 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over LEE in view of Allavatam et al. (US 20140275917 A1; hereinafter “Allavatam”).
Regarding claim 12, the prior art applied to the preceding linking claim(s) teaches the features of the linking claim(s).
LEE does not explicitly disclose:
wherein the state machine is further configured to compare second-order statistics of the first peak and the second peak.
But Allavatam teaches:
comparing second-order statistics of the first peak and the second peak (i.e., “beat-to-beat similarity may be incorporated to generate another score. For example, largest peaks for a number of consecutive detected events can be assessed (using, for example, sum of differences, variance or standard deviation, or maximum to minimum largest peak difference), and a score generated from the measure of beat to beat amplitude variation”; see [0068]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify LEE in view of Allavatam, such that the state machine is further configured to compare second-order statistics of the first peak and the second peak, as claimed. The rationale would be to assess the usefulness of the sequence of samples (see Allavatam, [0068]).
Regarding claim 20, the claim recites the same substantive further limitations as claim 12 and is rejected by applying the same teachings.
Notes
Claims 1 and 8 distinguish over the closest prior art of record as discussed below.
Regarding claim 8, the closest prior art of record fails to teach the features: “wherein locally refining the peak position includes interpolating a location of a maximum for a number of sequential samples within the time domain data having similar magnitudes,” in combination with the rest of the claim limitations as claimed and defined by the Applicant.
LEE’s interpolation is by determining a corrected peak position by using a rising regression cure and a falling regression curve. It is different from the above indicate feature.
NAKAMURA et al. (US 20170303862 A1) teaches processing biological information, involving refining a peak position by interpolation using curve fitting individual peaks.
Keenan et al. (US 20050240087 A1) teaches processing data from ambulatory physiological monitoring signals, involving interpolating a constructed R wave at an expected temporal position of a discarded ectopic R wave.
None of the closest prior art of record, singly or in combination, teaches or suggest the above indicated features at issue.
Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mazomenos et al. ("A Time-Domain Morphology and Gradient based Algorithm for ECG Feature Extraction" ICIT 2012) teaches a time domain Morphology and Gradient based method for extracting PQRST complex from ECG data.
Kaemmerer et al. (US 20230371822 A1) teaches a method of tracking a physiologic signal of a person, involving peak detection, peak validation, and HR calculation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN C KUAN whose telephone number is (571)270-7066. The examiner can normally be reached M-F: 9:00AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Schechter can be reached at (571) 272-2302. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN C KUAN/Primary Examiner, Art Unit 2857