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 .
Status of Claims
Claims 1-20 are rejected.
Response to Arguments
Claim Rejections - 35 USC § 101
Applicant's arguments filed 6/1/26 have been fully considered but they are not persuasive.
Applicant asserts that claim 1 has been amended to clarify that the multi-lead artifact detection loop relies on a computerized transformation of physiological time-domain signals into a frequency-domain profile to isolate signal spikes at predetermined target frequencies. Applicant further asserts that the functions of converting raw, multi-lead biological voltage streams into a frequency-domain representation (such as an FFT profile) requires intensive computational processing that is fundamentally outside the capability of the human mind. However, the Examiner disagrees. A Fast Fourier Transform (FFT) can be done by hand. The claim also does not specify that it has to be FFT. The amendment is directed to the abstract idea. A medical professional can transform a print out of ECG signals into the frequency domain and identify spikes at predetermined frequencies to detect artifacts.
Applicant asserts that a human observer performing manual evaluation, judgement, or opinion on a periodic basis cannot maintain a parallel transformation loop operating uninterrupted on live streams of data. The Examiner cites Applicant to MPEP 2106.05(f) which states:
Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).
Applicant asserts that the artifact and leadwire reversal detectors can provide feedback to the device user as to whether the ECG currently has substantial artifact or leadwire reversal (See specification ¶141). Applicant further asserts that functionality removes the claimed invention from an abstract idea of a mental process. However, the Examiner disagrees. A medical professional can generate a notification by writing it down. In addition, the notification amounts to post-solution activity.
Applicant asserts that the recited functions are fully integrated into a specific, non-abstract practical application. Applicant asserts that there is an improved analysis of ECG signals. However, the Examiner disagrees. The alleged improvement is directed to the abstract idea. An improvement to the abstract idea is still an abstract idea.
Applicant cites to CardioNet, LLC v. InfoBionic, Inc., 955 F.3d 1358 (Fed. Cir. 2020). However, the judicial exception alone cannot provide the improvement. See MPEP 2106.05(a):
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.
Double Patenting
The double patenting rejection has been withdrawn in view of the Terminal Disclaimer.
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 a judicial exception, specifically an abstract idea.
Step 1
The claimed invention in claims 1-20 are directed to statutory subject matter as the claims recite a method, device, and non-transitory computer-readable medium for analyzing electrocardiogram (ECG) signals.
Step 2A, Prong One
Regarding claims 1, 16, and 19, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsection (III)).
Regarding claims 1, 16, and 19, the limitations of “detecting multiple different artifacts in one or more of the ECG signals by transforming the ECG signals into a frequency domain and identifying spikes at predetermined frequencies; mapping leads of the multiple leads that contain one of the multiple different artifacts into respective groups of leads; for each group of the groups of leads, the ECG device identifying a common electrode contributing to generation of the ECG signals provided by the leads of the group; generating a notification…indicating that the common electrode for each group is sensing an artifact; and performing said detecting, mapping, identifying, and generating continuously as the ECG signals are being received” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing print outs of ECG signals, converting the ECG signals to the frequency domain, detecting multiple different artifacts by identifying spikes at predetermined frequencies, analyzing print outs of lead data and mapping the leads into groups based on the different artifacts, noticing patterns to identify a common electrode, and writing down that the common electrode for each group is sensing an artifact, and performing these steps continuously when the signals are received, which could be every few hours.
Step 2A, Prong Two
For claims 1, 16, and 19, the judicial exception is not integrated into a practical application. In particular, claims 1, 16, and 19 recite “an ECG device, a multi-lead ECG system including multiple electrodes and multiple leads, each lead of the multi-lead ECG system is coupled to more than one of the multiple electrodes, wherein certain electrodes are coupled to more than one lead, and generating a notification.” The multi-lead ECG system including multiple electrodes and multiple leads, each lead of the multi- lead ECG system is coupled to more than one of the multiple electrodes, and wherein certain electrodes are coupled to more than one lead amount to nothing more than pre-solution activity of data gathering. The ECG device is recited at a high-level of generality and amount to nothing more than parts of a generic computer. The step of generating a notification amounts to post-solution activity. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into
a practical application, the additional elements of multi-lead ECG system including multiple electrodes and multiple leads, each lead of the multi- lead ECG system is coupled to more than one of the multiple electrodes, and wherein certain electrodes are coupled to more than one lead amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the multi-lead ECG system including multiple electrodes and multiple leads, each lead of the multi- lead ECG system is coupled to more than one of the multiple electrodes, and wherein certain electrodes are coupled to more than one lead are recited at a high level of generality and are well-understood, routine, and conventional structures as evidenced by US 20110082359 (¶3-in conventional 12-lead ECG, an electrode is placed on each limb and six electrodes are placed at standard locations on the chest. A complete 12-lead ECG therefore includes ten electrodes placed at ten different standard locations on the subject. Twelve electrical lead signals are acquired using various combinations of these ten electrodes), US 20040024328 (¶14-the conventional 12-Lead ECG set employs 10 electrodes including the four limb electrodes LA, RA, LL, RL and six chest electrodes V1, V2, V3, V4, V5, and V6 and these are used to provide 12 conventional ECG lead signals labeled I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, and V6 as known), and US 20140194760 (¶10-conventional 12-lead ECG configuration typically uses 10 electrode positions, which may mean the placement of ten separate electrodes in these positions). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Regarding dependent claims 2-15, 17-18, and 20, the limitations of claims 1, 16, and 19 further define the limitations already indicated as being directed to the abstract idea.
Regarding claim 2, the ECG device is recited at a high-level of generality and amount to nothing more than parts of a generic computer. The multi-lead ECG system amounts to nothing more than pre-solution activity of data gathering as recited above.
Regarding claim 3, the multi-lead ECG system amounts to nothing more than pre-solution activity of data gathering as recited above. The defibrillator is a well-understood, routine, and conventional structure as evidenced by US 20110282162 (¶39-conventional implantable and automatic defibrillator systems), US 20090070054 (¶11-conventional defibrillator/monitors), and US 20030171798 (¶74-conventional defibrillators).
Claims 4, 17, and 20 further define the abstract idea.
Regarding claim 5, the limitation of “wherein determining that the portion of the one or more of the ECG signals is outside of the range of voltage values comprises: determining that an amplitude of the portion of the one or more of the ECG signals is above 5 mV” is a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing a print out of the ECG signals and determining that the portion of the one or more of the ECG signals is outside of the range of voltage values when an amplitude of the portion of the one or more of the ECG signals is above 5 mV.
Regarding claim 6, the limitation of “wherein determining that the portion of the one or more of the ECG signals is outside of the range of voltage values comprises: determining that a slope of the portion of the one or more of the ECG signals is above 1 mV/msec” is a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing a print out of ECG signals and determining that the portion of the one or more of the ECG signals is outside of the range of voltage values when a slope of the portion of the one or more of the ECG signals is above 1 mV/msec.
Regarding claim 7, the limitation of “wherein determining that the portion of the one or more of the ECG signals is outside of the range of voltage values comprises: determining that a number of zero crossing of the portion of the one or more of the ECG signals exceed a threshold over a time period” is a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing a print out of ECG signals and determining that the portion of the one or more of the ECG signals is outside of the range of voltage values when a number of zero crossing of the portion of the one or more of the ECG signals exceed a threshold over a time period.
Regarding claim 8, the limitation of “wherein determining that the portion of the one or more of the ECG signals is outside of the range of voltage values comprises: determining that a number of slope reversals of the portion of the one or more of the ECG signals exceed a threshold over a time period” is a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing a print out of ECG signals and determining that the portion of the one or more of the ECG signals is outside of the range of voltage values when a number of slope reversals of the portion of the one or more of the ECG signals exceed a threshold over a time period.
Claim 9 further defines the abstract idea.
Claims 10 and 18 further define the abstract idea. Additionally, the display is recited at a high-level of generality and amount to nothing more than parts of a generic computer.
Regarding claim 11, the limitations of “identifying a pattern in the ECG signals by comparison of a P wave and a QRS complex in the ECG signals from the multiple leads; and for the leads of the multiple leads in which the pattern is identified, identifying a leadwire reversal” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional analyzing a print out of ECG signals for a pattern by comparing a P wave and a QRS complex in the ECG signals, and for the leads of the multiple leads in which the pattern is identified, identifying a leadwire reversal.
Regarding claim 12, the limitations of “identifying an R wave amplitude change pattern in the ECG signals from a lead of the multiple leads that includes a pattern other than increasing monotonically from a first precordial lead to a fourth precordial lead and then decreasing monotonically; and for the lead of the multiple leads having the R wave amplitude change pattern other than increasing monotonically from the first precordial lead to the fourth precordial lead and then decreasing monotonically, identifying a leadwire reversal” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional identifying an R wave amplitude change in prints outs of ECG signals, and for the lead of the multiple leads having the R wave amplitude change pattern other than increasing monotonically from the first precordial lead to the fourth precordial lead and then decreasing monotonically, identifying a leadwire reversal.
Regarding claim 13, the limitations of “identifying an S wave amplitude change pattern in the ECG signals from a precordial lead of the multiple leads that includes a pattern other than first decreasing and then increasing; and for the precordial lead of the multiple leads having the S wave amplitude change pattern other than first decreasing and then increasing, identifying a leadwire reversal” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional identifying an S wave amplitude change in print outs of ECG signals, and for the precordial lead of the multiple leads having the S wave amplitude change pattern other than first decreasing and then increasing, identifying a leadwire reversal.
Regarding claim 14, the limitation of “generating a second notification…indicating a leadwire reversal” is a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, this limitation is nothing more than a medical professional writing down there is a leadwire reversal.
Regarding claim 15, the ECG device is recited at a high-level of generality and amount to nothing more than parts of a generic computer. The multi-lead ECG system amounts to nothing more than pre-solution activity of data gathering as recited above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
NPL “Electrocardiographic artifacts due to electrode misplacement and their frequency in different clinical settings”: the aim of this study was to detect artifacts due to erroneously switched ECG electrodes and to investigate their frequency in 2 distinct clinical settings (page 174, right col.).
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.
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/L.N.H./Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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