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 .
Election/Restrictions
Claims 4-10 & 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 6, 2025.
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 & 11-14, 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 at least in part 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…”
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 at least in part based 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
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 § 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)(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(s) 1-3 & 11-14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Xue et al. (US 5,792,065).
Xue et al. discloses;
1.
A method for determining a QT interval of an electrocardiogram (ECG) signal, the method comprising the steps: determining a maximum slope of the ECG signal after a T wave maximum of the ECG signal;
E.G. via the disclosed method for determining QT dispersion in ECG waveforms comprising a means 24 for determining a critical T-wave marker point(s) via a T-wave detection function that corresponds to maximum slopes of the original T-wave [(col 4, lines 6-32) & (col 5, lines 39-50)]., i.e. determining the T-end around the maximum slope after T-peak and a threshold value (col 2, lines 27-37).
fixing an end of the QT interval at least in part based on performing at least one of:
- extrapolating the maximum slope to a zero line of the ECG signal,
- determining a time position of the ECG signal 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.
E.G. via the disclosed step of locating and analyzing the T-peak, the maximum slope point (MSP) and several neighboring points along the MSP, i.e. points prior to the MSP, the MSP and points after the MSP, wherein the least-square method is used to ‘fit’ a straight line between said points in addition to another line drawn with a defined-threshold used in order to calculate the QT dispersions (col 6, lines 28-45), therefore providing the QT interval based on extrapolating the maximum slope to a zero line and/or calculating a second derivative of the ECG signal to determine an inflection point after the time position of the maximum slope (e.g., the disclosed points after the MSP) as is instantly claimed.
Note: The examiner notes that the claim limitation only requires that “at least in part based on performing at least one of,” of the extrapolating, determining, and/or calculating, i.e. as long as the prior art meets at least one of the claimed method steps of extrapolating, determining or calculating then claim limitation is met.
and correcting the QT interval for the heart frequency.
E.G. via the disclosed method of determining QT dispersion, wherein said QT dispersions are calculated and their heart-rate values corrected based on critical markers such as the T-wave peaks (col 4, lines 6-22).
Note: The examiner is interpreting the disclosed calculated and corrected QT dispersion and heart-rate values as providing the method step of ‘correcting the QT interval,’ as is instantly claimed. The examiner also notes that no specific method step is claimed to provide how the ‘correcting’ is accomplished, i.e. there is no mathematical equation and/or specific set of steps for the ‘correcting’, and therefore the disclosed calculated and corrected QT dispersion provides the claimed limitation.
2.
A method for determining a QT interval of an electrocardiogram (ECG) signal, the method comprising the steps: searching for a zero slope of the ECG signal after a T wave maximum of the ECG signal;
E.G. via the disclosed threshold defined in the T-P segment which is baseline plus one standard deviation in the window [(col 6, lines 28-38] & (Fig 7)].
Note: The examiner is interpreting the disclosed baseline as defined by the T-P segment as being the zero slope of the ECG signal since said T-P segment is a flat (horizontal) line which means that it has a slope of zero (col 6, lines 36-38).
and fixing an end of the QT interval of the ECG signal at least in part based on determining a time position of a first zero slope of the ECG signals.
E.G. via the disclosed method of determining the “line” with a threshold defined in the T-P segment based on the points 34-40 along said line [(col 6, lines 28-38] & (Fig 7)].
3.
The method of claim 1, wherein determining the QT interval comprises averaging at least two results obtained when performing the fixing step..
E.G. via the disclosed step of calculating the QT dispersion based on the T-peak and T-end points utilizing a template matching, U matrix equation and finding the maximum slope point after the final T-peak (col 6, lines 1-43).
11.
The method of claim 1, further comprising the step of: determining a heart frequency from the ECG signal.
E.G. via the disclosed use of ‘regional’ centering step that can accommodate for the morphasic and/or biphasic characteristics of the T-wave morphology [(col 5, lines 58-67)-(col 6, lines 1-5)].
12.
A non-transitory computer program product having instructions for causing a computer to execute the steps of the method according claim 1.
E.G. via the disclosed programmed computer that includes means for performing the functions of the disclosed method (col 4, lines 6-32).
13.
An apparatus for monitoring a QT interval of an electrocardiogram (ECG) signal comprising: a processor operable to: determine a maximum slope of the ECG signal after a T wave maximum of the ECG signal;
E.G. via the disclosed processor 14 that is programmed to perform the method/functions for determining QT dispersion in ECG waveforms comprising a means 24 for determining a critical T-wave marker point(s) via a T-wave detection function that corresponds to maximum slopes of the original T-wave [(col 4, lines 6-32) & (col 5, lines 39-50)]., i.e. determining the T-end around the maximum slope after T-peak and a threshold value (col 2, lines 27-37).
fix an end of the QT interval based at least in part on performing at least one of:
- extrapolate the maximum slope to a zero line of the ECG signal for fixing an end of the QT interval:
- determine a time position of the ECG signal after the T wave maximum at which the slope is for the first time within a range of 70% to 20%, preferred 66% to 25% of the maximum slope;
- calculate a second derivative of the ECG signal to determine an inflection point which is closest to the time position of the maximum slope.
and correct the QT interval for the heart frequency.
E.G. via the disclosed step of locating and analyzing the T-peak, the maximum slope point (MSP) and several neighboring points along the MSP, i.e. points prior to the MSP, the MSP and points after the MSP, wherein the least-square method is used to ‘fit’ a straight line between said points in addition to another line drawn with a defined-threshold used in order to calculate the QT dispersions (col 6, lines 28-45), therefore providing the QT interval based on extrapolating the maximum slope to a zero line and/or calculating a second derivative of the ECG signal to determine an inflection point after the time position of the maximum slope (e.g., the disclosed points after the MSP) as is instantly claimed.
Note: The examiner notes that the claim limitation only requires that “at least in part based on performing at least one of,” of the extrapolating, determining, and/or calculating, i.e. as long as the prior art meets at least one of the claimed method steps of extrapolating, determining or calculating then claim limitation is met.
Response to Arguments
Applicant’s arguments, filed December 2, 2025, with respect to the 35 U.S.C. 112 and claim objections have been fully considered and are persuasive and have been withdrawn.
Applicant's arguments filed December 2, 2025 have been fully considered but they are not persuasive. The applicant argues the following point(s) in which the examiner provides a reason(s) as to why the arguments are not persuasive:
Based on the applicant’s claim amendments, “correcting the QT interval for the heart frequency,” the applicant argues that the claims are not directed to an abstract idea because said amendments have integrated the abstract idea into a practical application, i.e. the claim amendment of “correcting the QT interval for the heart frequency,” is an active step based on the calculations stated by the claims to prevent a particular and medical harm, which provides a technological improvement to a monitoring device.
Based on the broadest reasonable interpretation of the claims the examiner disagrees and further points out that the applicant’s arguments that the amendment “correcting the QT interval for the heart frequency,” integrates the judicial exception into a practical application as a technological improvement is not persuasive.
The amended limitation merely refines the mathematical analysis of physiological data and does not impose any meaningful limit of the judicial exception. The claim limitation also does not recite an improvement to the functioning of an additional elements claimed, nor does it effect a transformation beyond the manipulation of data, as is stated in the above 2-Prong test. The amendment states an additional processing step that uses the abstract idea to generate more accurate information, i.e. correction of the QT interval, which is insufficient to integrate the exception into a practical application. Please see the above rejection, and therefore, the claims remain directed to the judicial except without significantly more.
Based on the amendments, i.e. the removal of the limitations, the applicant argues that the primary reference, Xue, fails to disclose or suggest fixing an end of the QT interval based on the one or more a) extrapolating the maximum slope to zero line of the ECG signal for fixing an end of the QT interval; b) determining a time position of the ECG signal after the T-wave maximum at which the slope is for the first time within a range of 70% to 20%, preferred 66% to 25% of the maximum slope; and/or c) calculating a second derivative of the ECG signal to determine an inflection point which is closest to the time position of the maximum slope.
Based on the broadest reasonable interpretation of the claims the examiner disagrees and further points out that Xue discloses the step of locating and analyzing the T-peak, the maximum slope point (MSP) and several neighboring points along the MSP, i.e. points prior to the MSP, the MSP and points after the MSP, wherein the least-square method is used to ‘fit’ a straight line between said points in addition to another line drawn with a defined-threshold used in order to calculate the QT dispersions (col 6, lines 28-45), therefore providing the QT interval based on extrapolating the maximum slope to a zero line and/or calculating a second derivative of the ECG signal to determine an inflection point after the time position of the maximum slope (e.g., the disclosed points after the MSP) as is instantly claimed.
The examiner notes that the claim limitation only requires that “at least in part based on performing at least one of,” of the extrapolating, determining, and/or calculating, i.e. as long as the prior art meets at least one of the claimed method steps of extrapolating, determining or calculating then claim limitation is met.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796