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 .
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.
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, specifically independent claims 1, 15 & 20, is directed to an abstract idea without significantly more. Please see the below analysis providing the details as to why the invention is directed towards non-statutory subject matter.
Step 1:
Claim 1 is directed towards a system, which is a product, i.e. a statutory category of invention.
Claim 15 is directed towards a method, i.e. a statutory category of invention.
Claim 20 is directed towards a computer-readable data storage medium comprising software, i.e. a statutory category of invention.
Step 2A, Prong 1:
Claims 1, 15 & 20 recites the method steps of:
“…receive a first electrocardiogram waveform…”
“…identify a feature in the first electrogram waveform…”
“…retrieve one or more second electrocardiogram waveforms…”
“…extract the feature from the one or more second electrocardiogram waveforms…”
“…generate one or more interpretive statements…”
“…display the one or more interpretive statements…”
These limitations, under their broadest interpretation, fall within the mental processes (i.e. receive, identify, retrieve, extract, generate, etc.). It would be practical, but for the recitation “at least one processing device” to perform the steps in a human’s mind, or with a pen and paper, to utilize the claimed signals.
Step 2A, Prong 2:
The claims as a whole fails to integrate the abstract idea into a practical application. Claim 1 recites the following additional elements, which for the reasons set forth below, do not integrate the abstract idea into a practical application.
Claim 1
“…at least one processing device…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
“…a memory device…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
“…on a cardiograph device…” which is directed to data output, 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 does 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 claim 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:
real-time discrete data obtained from a medical device/data previously collected from a medical device (i.e. body surface/unipolar electrodes) Presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93; Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network).
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, the claims fail to recite significantly more than the abstract idea and claims 9-28 are rejected under 35 U.S.C 101.
The limitations of the dependent claims 2-14 & 16-19 further defines steps of identifying the feature of the first electrocardiogram waveform, the executed instructions of the at least one processing device, generating one or more interpretive statements, etc. which further limit claim limitations already indicated above as being directed to an abstract idea. Therefore, the above claims 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) 1-6 & 8-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xue (US 2017/0105683) in view of one having ordinary skill in the art, as evidence by KSR International Co. v. Telefax Inc..
Xue discloses;
1.
a system for interpreting ECGs including a processor and memory storing executable instructions.
E.G., [0021], [0033], (Fig 5).
receiving a first ECG waveform for a patient
E.G. via receiving new ECG waveform 17, [0021].
identifying a feature in the first ECG waveform
E.G. via extracting features 14 including waveform amplitudes, intervals, ST elevation characteristics, etc.; [0021], [0029]-[0030]
retrieving prior ECG waveform datasets for comparison processing
E.G. via the existing ECG databases 3a-3n stored in cluster database 20; [0022], [0027], [0029]-[0030].
extracting features from raw waveform data of the prior ECG waveforms
E.G. [0021]-[0022], [0029]-[0030].
generating interpretive statements based on comparison of extracted ECG waveform features
E.G via the disclosed cluster interpretation outputs 32 and general interpretation outputs 34; [0019], [0021]-[0022], [0025]-[0032]
displaying the interpretive statements on a user interface/device
E.G., [0025].
Xue does not explicitly disclose retrieving prior ECG waveforms previously recorded for the same patient. However, it would have been obvious to one of ordinary skill in the art to modify Xue to retrieve prior ECG waveforms associated with the same patient in order to improve ECG interpretation accuracy using patient-specific baseline comparisons, since such comparisons were well known for accounting for inter-patient physiological variability and improving diagnostic reliability.
Further, the modification merely involves the predictable use of prior art elements according to their established functions to improve similar ECG interpretation systems. KSR Int’l Co. v. Telefax Inc.
2.
Claim 2 is rejected under 35 U.S.C. § 103 over Xue in view of KSR because Xue discloses identifying ECG abnormalities/pathologies based on extracted waveform features and classifications.
E.G. [0021], [0027], [0029].
3.
Claim 2 is rejected under 35 U.S.C. § 103 over Xue in view of KSR because Xue discloses generating confidence values/weighted classifications for interpretation outputs.
E.G. [0027]-[0028].
4.
Claim 4 is rejected under 35 U.S.C. § 103 over Xue in view of KSR because Xue discloses presenting modified or alternative interpretation outputs based on extracted ECG features and clinician feedback
E.G. [0019], [0025]-[0026].
5.
Claim 5 is rejected under 35 U.S.C. § 103 over Xue in view of KSR because it would have been obvious to selectively disregard prior ECG waveform comparisons when the prior ECG waveforms are temporally too remote to provide reliable clinical comparison data, as a predictable optimization of ECG interpretation accuracy.
6.
Claim 6 is rejected under 35 U.S.C. § 103 over Xue in view of KSR because selecting a threshold time period, including five days, constitutes a result-effective variable routinely optimized by one of ordinary skill in the art.
8.
Claim 6 is rejected under 35 U.S.C. § 103 over Xue in view of KSR because Xue discloses identifying ECG features using trained interpretation/classification modules and machine learning processing.
E.G. [0027], [0030], [0032]. It is also noted that saliency mapping represents a known feature-identification technique in machine learning systems.
9.
Claim 9 is rejected under 35 U.S.C. § 103 over Xue in view of KSR because Xue discloses:
identifying abnormalities/pathologies in ECG waveforms
E.G. [0021], [0027], [0029].
comparing extracted features with prior datasets/interpretations
E.G. [0022], [0027]-[0028]
generating different outputs/alerts based on whether corresponding abnormalities are identified
E.G. [0019], [0025]-[0026].
10.
Claim 10 is rejected under 35 U.S.C. § 103 over Xue in view of KSR because Xue discloses increasing confidence values for interpretation outputs based on comparison/training feedback and validated classifications.
E.G. [0027]-[0032].
11.
Claim 11 is rejected under 35 U.S.C. § 103 over Xue in view of KSR because Xue discloses:
determining Q-wave related features from ECG leads/waveforms
E.G. [0021], [0029]
comparing waveform features between ECG datasets
E.G. [0022], [0027]-[0029].
generating interpretation outputs based on detected waveform differences
E.G. [0019], [0025].
12.
Claim 12 is rejected under 35 U.S.C. § 103 over Xue in view of KSR because Xue discloses determining ST elevation features from ECG waveforms and generating interpretation outputs based on differences/comparisons between ECG datasets.
E.G. [0021], [0029], [0032].
13.
Claim 13 is rejected under 35 U.S.C. § 103 over Xue in view of KSR because Xue discloses comparing ECG waveform morphology/features between ECG datasets and generating interpretation outputs based on detected differences.
E.G. [0021]-[0022], [0029]-[0030]
14.
Claim 14 is rejected under 35 U.S.C. § 103 over Xue in view of KSR because Xue discloses machine learning interpretation modules, including neural networks and decision trees, for ECG feature identification and interpretation processing.
E.G. [0027], [0030], [0032].
15.
Claim 15 is rejected under 35 U.S.C. § 103 over Xue in view of KSR for substantially the same reasons set forth with respect to claim 1.
16.
Claim 16 is rejected under 35 U.S.C. § 103 over Xue in view of KSR for substantially the same reasons set forth with respect to claim 3.
17.
Claim 17 is rejected under 35 U.S.C. § 103 over Xue in view of KSR for substantially the same reasons set forth with respect to claim 4.
18.
Claim 18 is rejected under 35 U.S.C. § 103 over Xue in view of KSR for substantially the same reasons set forth with respect to claim 9.
19.
Claim 19 is rejected under 35 U.S.C. § 103 over Xue in view of KSR for substantially the same reasons set forth with respect to claim 10.
20.
Claim 20 is rejected under 35 U.S.C. § 103 over Xue in view of KSR for substantially the same reasons set forth with respect to claim 1.
Response to Arguments
Applicant's arguments filed April 7, 2026 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:
The applicant argues that amended independent claims are directed to a technological improvement involving comparison of patient-specific electrocardiogram waveforms and generation of interpretive statements based upon extracted waveform features from raw waveform data, allegedly improving cardiac interpretation systems.
The examiner disagrees. When considered as a whole, claim 1 is directed to the abstract idea of collecting information, analyzing the information, and presenting the results of the analysis, which recites receiving electrogram waveform data, identifying features, retrieving prior waveform data, extracting features, comparing waveform features…displaying the interpretive statements. Such operations merely recite observations, evaluation, analysis and reporting of medical information, which can practically be performed in the human mind or using pen and paper.
The additional claim elements, including the recited processing device, memory device and cardiograph device, merely constitute generic computer components performing conventional data gathering, processing, storage and display functions. The claims do not recite any improvement to the functioning of a computer itself, nor any particular improvement to ECG acquisition hardware or signal processing technology. Rather, the claims use generic computing components as tools to perform the abstract analysis.
The applicant argues that the claims improve the accuracy of ECG interpretation by using patient-specific prior ECG waveforms.
The examiner notes that improving the quality or relevance of information presented to a user does not constitute an improvement in computer technology or another technical field for purpose of Step 2A, Prong Two. The alleged improvement resides in the abstract idea itself, namely the analysis and comparison of medical information to generate interpretive conclusions.
Additionally, the claims does not recite a specific technological mechanism for improving ECG signal acquisition, waveform extraction or machine operation. The claim merely recites result-orientated functional language directed to comparing waveform features and generating interpretive statements without reciting a particular technological solution for achieving those results.
The applicant argue that the claims are not analogous to merely comparing diagnostic codes because the claims compare extracted waveform features of raw waveform data.
This arguments is not persuasive because the claimed operation still amounts to collecting medical data, analyzing the data according to identified relationships and displaying the results of that analysis. The mere use of waveform-derived information rather than diagnostic codes does not integrate the abstract idea into a practical application.
Under Step 2B, the claims likewise fail to recite significantly more than the abstract idea itself. The additional elements, individually and in combination, amount only to generic and well-understood computer implementation of data analysis functions. The claims do not recite any unconventional hardware arrangement, specialized processing architecture or non-routine technological implementation sufficient to amount to significantly more than the judicial exemption.
Accordingly, the rejection under 35 U.S.C. § 101 is maintained.
The applicant argues that the primary reference, Xue, fails to disclose retrieving “one or more second electrogram waveforms previously recorded for the patient,” and instead merely discloses clustered ECG databases grouped accorded to common features rather than patient identity.
The examiner disagrees and points out that Xue discloses processing existing ECG datasets associated with previously obtained ECG waveforms and corresponding extracted features for comparative interpretation processing, [0021]-[0030]. In particular, Xue discloses retrieving existing ECG datasets 3a-3n from cluster database 20 and comparing extracted features from a current ECG waveform against features extracted from prior ECG datasets in order to generate interpretation outputs, [0022], [0027]-[0029].
Although Xue may not explicitly state that the prior ECG datasets are associated with the identical patient, it would have been obvious to one of ordinary skill in the art at the time the invention to utilize previously recorded ECG waveforms associated with the same patient rather than unrelated patients because patient-specific historical ECG comparison are well-known in the art to improve diagnostic accuracy, baseline comparison reliability and longitudinal cardiac assessment. Modifying Xue to use patient-specific prior ECG records merely constitutes the predictable use of prior art elements according to their established functions. KSR Int’l Co. v. Telefax Inc, 550 U.S. 398, 417 (2007).
The applicant argues that the amended claim 1 requires comparing extracted features from “raw waveform data” of prior ECG waveforms, whereas Xue allegedly only compares cluster interpretation outputs.
This argument is not persuasive because Xue expressly discloses extracting features from ECG waveform data using feature extraction algorithms prior to interpretation processing, [0021]-[0022]. Xue further discloses that extracted waveform features 14 from ECG waveform 17 are processed by cluster interpretation modules to generate interpretation outputs. Therefore, Xue discloses generating interpretation outputs based on extracted waveform features derived from ECG waveform data. The examiner also notes that comparing extracted features from prior ECG waveforms belonging to the same patient would have been obvious for the reasons discussed above, namely improving interpretation relevance and diagnostic consistency through patient-specific historical waveform comparison.
The applicant further argues that amended claim 1 generates interpretive statements based upon comparison between current ECG waveform features from the same patient, allegedly differing from Xue’s clustering-based interpretation approach.
However, the examiner notes that Xue expressly discloses comparing extracted ECG features and generating interpretation outputs based upon those comparisons, [0022], [0027]-[0029]. The mere fact that Xue additionally utilizes clustered interpretation modules does not preclude or teach away from performing patient-specific prior ECG data into Xue’s comparative interpretation system would merely represent the application of a known technique to improve similar devices in the same way.
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.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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