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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 21, 2026 has been entered.
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 1-3 & 11-13, specifically independent claims 1 & 13, are rejected under 35 U.S.C 101 because the claimed invention is directed to an abstract idea, judicial exemption, without significantly more. Please see the below 2 step, prong analysis:
Step 1:
Claim 1 is directed to a method, which is a statutory category of invention.
Claim 13 is directed to an apparatus, which is a statutory category of invention.
Step 2A, prong 1:
Claims 1 & 13 recites limitations that are directed to an abstract idea.
Claim 1 recites method steps directed to:
“…determining a maximum slope of the ECG signal…”
“…fixing an end of the QT interval to generate a QT fixed end interval based on performing at least one of…”
“…extrapolating the maximum slope to a zero line…”
“…determining a time position of the ECG signal…”
“…calculating a second derivative of the ECG signal to determine an inflection point…”
“…correcting the QT interval for the heart frequency……to generate a corrected QT interval based on a Fridericia formula…”
Claim 13 recites method (via a processor operable to) steps directed to:
“…determine a maximum slope of the ECG signal…”
“…fixing an end of the QT interval to generate a QT fixed end interval on performing at least one of…”
“…extrapolate the maximum slope to a zero line…”
“…calculate a second derivative of the ECG signal to determine an inflection point…”]
“…correct the QT interval for the heart frequency…to generate a corrected QT interval based on a Fridericia formula…
These limitations, under their broadest reasonable interpretation, fall within the mental processes grouping (fixing, extrapolating, correcting) and mathematic concept grouping (determining, calculating) of abstract ideas. It would be practical, but for the recitation “a processor operable to” to perform the steps in a human's mind, or with pen and paper, to utilize the image and/or biological data.
Step 2A, Prong 2:
The claims as a whole fails to integrate the abstract idea into a practical application. Claim 13 recites the following additional elements, which for the reasons set forth below, do not integrate the abstract idea into a practical application.
“…a processor operable to…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
Therefore, the claims fail to integrate the abstract idea into a practical application. The examiner also notes that the additional elements recited in claim 1 do not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. The claim is silent to providing any treatment at all to a patient.
Step 2B:
The claims as a whole fails to recite an inventive concept. The additional elements, when considered individually and in combination, do not recite significantly more than the abstract idea for the reasons as set forth above in Step 2A, Prong 2. Upon re-evaluating the limitation that was previously identified as insignificant extra-solution activity in Step 2A, Prong 2, the following evidence to show that the limitation is well-understood, routine and conventional:
producing at said computer processor a human-readable output (i.e. processor) of the analysis of the gathered data, this is also WURC, as evidenced by Electric Power Group, LLC v. Alstom S.A., 830F.3d 1350, 119 USPQ2d 1739 (Fed.Cir. 2016), which discusses “conventional computer, network, and display technology” and states that “nothing in the patent contains any suggestion that the displays needed for that purpose are anything but readily available. We have repeatedly held that such invocations of computers and networks that are not even arguably inventive are “insufficient to pass the test of an inventive concept in the application” of an abstract idea”.” Similarly, there is nothing in Applicant’s specification that indicates that the device that is “producing at said computer processor a human-readable output indicating” the findings of the analysis is anything but readily available.
Therefore, claim 1 & claim 13 fails to recite significantly more than the abstract idea and claims 9-28 are rejected under 35 U.S.C 101.
Note: Regarding the dependent claims, i.e. claims 2-3 & 11-12 the limitations define steps of searching for a zero slope, fixing an end of the QT interval, using at least two items, determining a heart frequency from the ECG signal, a computer program having instructions for causing to execute the steps, which further limit claim limitations already indicated above as being directed to an abstract idea. Therefore, claims 2-3 & 11-12 are directed to patient-ineligible subject matter.
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.
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.
Claim(s) 1-3. 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xue et al. (US 5,792,065) in view of Lux et al. (US 2008/0015453) and further in view of Johnson (US 2011/0196246).
Xue et al. teaches a method of determining QT interval markers from an ECG signal, including identifying T-wave markers, determining T-end, and generating heart-rate corrected QT values; (col 4, lines 10-18 & 27-33) & (col 6, lines 27-39)
Specifically, Xue teaches:
“A method for correcting a QT interval of an ECG…”
E.G. via the disclosed determination of critical T-wave marker points and calculating QT values from ECG signals; (col 4, lines 10-18 & 27-33).
“…determining a maximum slope of the ECG signal after a T-wave maximum of the ECG signal…”
E.G. via the location of a T-peak and subsequently determining a maximum slope point (MSP) after the final T-peak, wherein the MSP is used to determine T-end; (col 6, lines 27-30).
“…fixing an end of the QT interval to generate a QT fixed end interval…”
E.G. via the disclosed determining T-end from the intersection of a least-squared fitted line around the maximum slope of reconstructed ECG signals after T-peak and a threshold value; (col 4, lines 27-33). Xue further teaches fitting a least-square line to a region surrounding the MSP and determining an initial T-end from the intersection of the fitted line and a threshold line; (col 6, lines 31-39).
“…extrapolating the maximum slope to a zero line of the ECG signal…”
E.G. via the disclosed extension of a line fitted to the region surrounding the maximum slope point to determine the T-end through intersection with a baseline-related threshold line; (col 6, lines 31-39).
However, Xue et al. does not explicitly disclose:
“…determining a time position after the T-wave maximum at which the slope of the ECG signal is for the first time within a range of 70% to 20%, preferably 66% to 25%, of the maximum slope;
“…calculating a second derivative of the ECG signal to determine an inflection point after the time position of the maximum slope which is closest to the time position of the maximum slope;
“…correcting the QT interval using the QT fixed end interval to generate a corrected QT interval (QTc) based on a Fridericia formula.
Lux et al. teaches:
Determination of ECG waveform characteristics using a second derivative of the waveform; [0035].
Correction of QT intervals for heart rate using the Fridericia formula; [0032]
Johnson teaches:
Identifying ECG feature locations using slope-based criteria;
Locating signal points based on threshold relationships relative to slope values;
Determining signal locations using adaptive threshold comparisons applied to slope measurements; [0015], [0048]-[0050].
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Xue’s T-end determination technique with the derivative-based waveform analysis and Fridericia correction taught by Lux et al. because both references are directed to ECG interval analysis and heart-rate corrected QT measurements and such modification would have predictably improved the accuracy and consistency of ECG marker identification and QT correction.
It further would have been obvious to incorporate Johnson’s slope-threshold analysis techniques into Xue’s maximum-slope-based T-end detection because Johnson teaches using threshold relative to measured slopes to identify ECG waveform locations, which would have been recognized as a predictable technique for refining the selection of points occurring after a maximum slope event.
Regarding the claimed range of 70% to 20%, preferably 66% to 25%, of the maximum slope, the exact percentage values are not disclosed verbatim in the applied references. However, selection of a particular threshold percentages relative to a detected maximum slope would have constituted no more than optimization of a known result-effective variable, Xue et al. already relies upon maximum-slope-based determination of T-wave markers and T-end location (col 6, lines 27-39), and Johnson teaches selecting ECG feature locations using threshold relationships relative to slope values ([0015], [0048]-[0050].
One of ordinary skill in the art would have recognized that varying the percentage threshold relative to the maximum slope would predictably affect the location selected along the waveform and would have arrived at the claimed percentage range through routine optimization to achieve a desired balance between sensitivity and robustness to waveform variability. See KSR Int’l Co. v. Teleflex Inc, 550 U.S. 398, 421 (2007).
According, claim 1 would have been obvious over Xue in view of Lux and Johnson
2.
“…searching for a zero slope after a T-wave maximum…”
E.G. via the disclosed location of the T-peak and subsequently identifying waveform locations after the T-peak using slope analysis and T-wave marker determination; Xue, (col 6, lines 27-39).
“…determining a first zero slope after the T-wave minimum…”
E.G. via the disclosed searching for locations where slope values satisfy threshold criteria approaching zero slope conditions during ECG feature detection; Johnson [0015], [0048]-[0050].
“…fixing QT end based on the determined location…”
E.G. via the disclosed determination T-end after T-peak based upon post-peak slope processing; Xue, (col 6, lines 27-39).
“…QTc = QTFixed end/(RR) 1/3
E.G. via the disclosed Fridericia correction; Lux [0032].
It would have been obvious to utilize Johnson’s slope-threshold detection methodology within Xue’s post T-wave endpoint detection process to identify a zero-slope location for fixing QT end because both references seek reliable ECG fiducial point determination.
3.
“…averaging at least two results obtained when performing the fixing step…”
E.G. via the disclosed determination T-wave markers across multiple information from multiple measurements; Xue (col 4, lines 15-25).
AND
E.G. via the disclosed averaging ECG-derived measurements including RR and QT intervals obtained from multiple beats; Lux [0032]
Averaging multiple QT-end determinations to reduce noise and improve reproducibility would have been an obvious signal-processing technique well known in the ECG analysis art.
11.
“…determining a heart frequency from the ECG signal…”
E.G. via the disclosed calculation of heart-rate corrected QT values from an ECG signal; Xue (col 4, lines 15-18) (col 5, lines 55-60).
AND
E.G. via the disclosed determination of RR intervals and applying Fridericia correction using heart rate; Lux, [0032]
Heart-rate determination is necessarily performed when generating QTc values.
12.
a non-transitory computer readable medium containing instructions causing a computer to execute the method of claim 1.
Claim 12 is rejected for the same reasons as claim 1 because the prior art teaches software-executed ECG processing methods stored and executed by a processor.
13.
“…processor configured to determine maximum slope after T-wave maximum…”
E.G. Xue, (col 6, lines 27-39)
“…processor configured to fix QT end interval…”
E.G. Xue, (col 4, lines 27-33), (col 6, lines 31-39).
“…processor configured to determine slope with 70-20% of maximum slope:
E.G. slope-threshold determination, Johnson, [0015], [0048]-[0050].
AND
E.G. optimization of percentage threshold would have been obvious as a result-effective variable. See KSR.
“…processor configured to calculate a second derivative and determine an inflection…”
E.G. Lux, [0035].
“…processor configured to generate QTc using Fridericia…”
E.G. Lux, [0035].
Response to Arguments
Applicant's arguments filed May 21, 2026 have been fully considered but they are not persuasive.
The applicant argues that the cited reference fails to teach determining a time position at which the slope is within a specified percentage range of a maximum slope, calculating a second derivative to determine an inflection point and correcting a QT interval using the claimed Fridericia formula.
The examiner notes that the rejection does not rely upon Xue et al. alone for these limitations. As explained in the rejection, Johnson teaches slope-threshold based ECG feature detection, )[0015], [0048]-[0050]) while Lux et al. teaches derivative-based ECG waveform analysis and Fridericia QT correction; [0032], [0035]. Xue et al. teaches determining T-wave marker points and QT interval endpoints using post-T-wave slope analysis; (col 6, lines 27-39).
It would have been obvious to incorporate the known ECG processing techniques of Lux et al. and Johnson into the QT interval determination system of Xue et al. to improve, robustness, and reproducibility of QT interval measurements. The proposed combination represents the predictable use of prior art elements according to their established functions and would have yielded predictable results. KSR, 550 U.S. 398 (2007).
In regards to the applicant’s arguments pertaining to the 35 U.S.C. § 101 rejections, the arguments have been considered but are not persuasive. Although the applicant contends that the recited Fridericia correction formula integrates any alleged abstract idea into a practical application, the claims remain directed to mathematical analysis of physiological data, including determining waveform characteristics and applying a mathematical formula to generate a corrected QT interval. Unlike the claims in Vanda, the instant claims do not recite administering or modifying a medical treatment based on the calculated result. Further, the claimed ECG signal acquisition and processor perform their ordinary functions of collecting and processing data and therefore do not integrate the judicial exception into a practical application or amount to significantly more than the exception.
Accordingly the rejection is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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