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 .
Drawings
The drawings are objected to because they contain handwritten labels. 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 Objections
Claims 4, 5, 7, 8, 10, 12, 13, and 18-20 are objected to because of the following informalities:
In claim 4, line 5, ‘the’ should be inserted before “ECG”.
In claim 5, line 3, the first “a” should be ‘the’.
In claim 7, line 3, the first and second “a” should be ‘the’.
In claim 8, line 3, ‘select’ should be ‘selected’.
In claim 10, line 2, the first ‘a’ should be ‘the’.
In claim 12, line 2, ‘a’ should be ‘the’.
In claim 13, line 2, ‘a’ should be ‘the’. In line 3, the first and second ‘a’ should be ‘the’.
In claim 18, line 2, the first ‘a’ should be ‘the’.
In claim 19, line 2, ‘a’ should be ‘the’.
In claim 20, line 2, ‘a’ should be ‘the’.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitation of claim 13 is already present in claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Halperin et al (US Pub 2015/0164433 -cited by applicant) in view of Yamakawa (US Pub 2020/0268269 -cited by applicant).
Re claims 1, 4, 13: Halperin discloses a system and method for estimating patient condition levels in a test individual [0005, 0121-0125, 0649-0660; see the onset/progression of a condition with a sensor 30 for measurement of data to be used to predict and monitor chronic disease], said method comprising:
using an electrocardiogram, obtaining a dataset of ECG measurements captured from the test individual [0121-0125, 0667; see the electrocardiogram and sensor data analysis used for prediction and monitoring of chronic disease];
using a computer based system/processor that is programmed with computer code converting the dataset of ECG measurements captured from the test individual to a frequency domain [0121-0125, 0667; see the acquiring of motion time domain signals and conversion to frequency domain]; and
using the computer based system/processor, comparing the dataset of ECG measurements in the frequency domain of the test individual with a reference dataset of ECG measurements in the frequency domain of a reference individual in order to estimate a condition level of the test individual [0028-0033, 0650-0660, 0667; see the signal pattern compared to predetermined reference patterns to determine a patient condition wherein an alert is generated if the evaluation indicates treatment is necessary; see the ECG where the system analyzes a motion signal of the subject in the frequency domain and identifies peaks in the frequency domain signal corresponding to respiration rate and heart rate].
Halperin discloses all features except that dementia level is determined. However, Yamakawa teaches estimating dementia level based on ECG measurements (see Abstract, see the ECG for early diagnosis of dementia). It would have been obvious to the skilled artisan to modify Halperin, to add the early diagnosis of dementia as taught by Yamakawa, as it allows use without specialized knowledge and allows detection with improved precision.
Re claims 2, 5, 7, 11, 12, 19, 20: Halperin discloses said comparing being at a plurality of harmonic ranges within the frequency domain, and wherein said comparing comprises scaling a difference in amplitudes in frequency domains to estimate the condition level based upon the difference in amplitudes, including a first domain of 10-20 harmonics, a second domain of 20-30 harmonics, and a third domain of 30-40 harmonics [0650-0660; the peaks in the frequency domain signal corresponding to respiration and heart rate are identified along with their corresponding harmonics, wherein the comparison with a predetermined reference pattern represents a difference in amplitudes]. Halperin discloses all features except that dementia level is determined. However, Yamakawa teaches estimating dementia level based on ECG measurements (see Abstract, see the ECG for early diagnosis of dementia). It would have been obvious to the skilled artisan to modify Halperin, to add the early diagnosis of dementia as taught by Yamakawa, as it allows use without specialized knowledge and allows detection with improved precision.
Re claims 3, 6, 8, 14, 15: Halperin disclsoes the reference individual is an individual that is substantially free of the condition, thereby being least likely to show signals of the condition [0649-0660; see the reference for tracking of pathophysiological deviations from normal patterns]. Halperin discloses all features except that dementia level is determined. However, Yamakawa teaches estimating dementia level based on ECG measurements (see Abstract, see the ECG for early diagnosis of dementia). It would have been obvious to the skilled artisan to modify Halperin, to add the early diagnosis of dementia as taught by Yamakawa, as it allows use without specialized knowledge and allows detection with improved precision.
Re claims 9, 10, 16-18: Halperion discloses the dataset of ECG measurements captured from the test individual comprises a plurality of ECG measurements, and wherein the plurality of ECG measurements is averaged and/or normalized to a common value, and the processor is operable to convert the dataset of ECG measurements captured from the test individual to a frequency domain by performing a frequency analysis using a fast Fourier transform (FFT) [0603; see the computing of the Fourier transform and see the averaging performed on the signal].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797