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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 30, 2025 has been entered.
Status of Claims
In the response filed December 30, 2025, no claims were amended. Claims 1-20 are pending in the current application.
Response to Arguments
Applicant's arguments with respect to the rejection under 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant asserts that the claims integrate the judicial exception into an abstract idea because the claims effect an improvement to the technical field of healthcare data and visualization and are analogous to Desjardins . Examiner respectfully disagrees. A claim whose entire scope can be performed mentally, cannot be said to improve computer technology. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 120 USPQ2d 1473 (Fed. Cir. 2016) (a method of translating a logic circuit into a hardware component description of a logic circuit was found to be ineligible because the method did not employ a computer and a skilled artisan could perform all the steps mentally). Similarly, a claimed process covering embodiments that can be performed on a computer, as well as embodiments that can be practiced verbally or with a telephone, cannot improve computer technology (see MPEP 2106.05 (a)(I)). In this case, the ECG monitoring device and computing device in the steps are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component. Unlike Desjardins, which performed an improved way of training a machine learning model that protected the model’s knowledge about previous tasks while allowing it to effectively learn new tasks. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The rejection is maintained.
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 claims are not directed to patent eligible subject matter.
Claims 1-20 do fall within at least one of the four categories of patent eligible subject matter because the claims recite a machine (i.e., system) and process (i.e., a method).
Although claims 1-20 fall under at least one of the four statutory categories, it should be determined whether the claim wholly embraces a judicially recognized exception, which includes laws of nature, physical phenomena, and abstract ideas, or is it a particular practical application of a judicial exception (See MPEP 2106 I and II).
Claims 1-20 are directed to a judicial exception (i.e., a law of nature, natural phenomenon, or abstract idea) without significantly more.
Part I: Step 2A, Prong One: Identify the Abstract Idea
Under step 2A, Prong One of the Alice framework, the claims are analyzed to determine if the claims are directed to a judicial exception. MPEP §2106.04(a). The determination consists of a) identifying the specific limitations in the claim that recite an abstract idea; and b) determining whether the identified limitations fall within at least one of the three subject matter groupings of abstract ideas (i.e., mathematical concepts, mental processes, and certain methods of organizing human activity). See 2019 Revised Patent Subject Matter Eligibility Guidance (“PEG” 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. No. 4, 50-57 (Jan. 7, 2019)).
The identified limitations of independent claim 1 (representative of independent claim 11) recite: an electrocardiogram (ECG) monitoring device to:
measure an ECG of a user to generate ECG data; and
transmit the ECG data;
a cloud analysis platform to:
receive the ECG data;
perform, using a machine learning (ML) model, a QT analysis based on the ECG data to generate QT analysis results, wherein the ML model is trained using:
training data comprising a plurality of ECG measurements and a target QT interval for each ECG measurement; and
a loss function based in part on a QT interval average; and
transmit the QT analysis results; and
a computing device to:
receive the QT analysis results; and
synthesize, based on the QT analysis results, a graphical user interface (GUI) to visualize the ECG data with the QT analysis results integrated therein, wherein the GUI comprises:
a grid on which waveforms corresponding to each lead of the ECG data are displayed adjacent to each other,
an indication of the QT analysis results and a display of additional information based on the QT analysis results;
an icon adjacent to the indication of the QT analysis results, wherein in response to user interaction with the icon, the GUI provides information regarding possible statuses of the indication of the QT analysis results in a popup window;
a grid length/measurement time equivalency;
an indication of a grid length/voltage equivalency;
a feature to request a physician review of the QT analysis results; and
an indication of a current status of the physician review of the QT analysis results.
The identified limitations, under their broadest reasonable interpretation, cover performance of the limitations in the mind (including observation, evaluation, judgement or opinion) but for the recitation of generic computer components. That is, other than reciting a ECG monitoring device and computing device, nothing in the claim elements precludes the steps form practically being performed in the mind. For example, the identified limitations encompasses a healthcare professional conducting QT analysis on ECG data using the Cardiac Ruler or Sequence Method manually or reading the display on a generic ECG monitoring device. The claim limitations fall within the Mental Processes groupings of abstract ideas. Thus, the claimed invention recites a judicial exception.
Part I: Step 2A, prong two: additional elements that integrate the judicial exception into a practical application
Under step 2A, Prong Two of the Alice framework, the claims are analyzed to determine whether the claims recite additional elements that integrate the judicial exception into a practical application. In particular, the claims are evaluated to determine if there are additional elements or a combination of elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claims are more than a drafting effort designed to monopolize the judicial exception (PEG 2019, Pg. 54).
This judicial exception is not integrated into a practical application. The ECG monitoring device and computing device in the steps are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Dependent claims 2-10 and 12-20, when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are not directed to an abstract idea. For instance, the claims recites limitations that can be performed manually using a generic ECG monitoring device.
Regarding claims 2 and 12, wherein the GUI comprises: an indication of an origin of the QT analysis results (mental processes).
Regarding claims 3 and 13, wherein the QT analysis results comprise: a QT value; and a QTcF value (mental processes).
Regarding claims 4 and 14, wherein the GUI further comprises: a feature to request a portable document format version of the visualization of the ECG data and the QT analysis results (mental processes).
Regarding claims 5 and 15, wherein the ECG monitoring device is further to: generate an interpretation of the ECG data; and transmit the interpretation along with the ECG data to the cloud analysis platform (mental processes).
Regarding claims 6 and 16, wherein the cloud analysis platform is further to: add the QT analysis results, patient data, the interpretation, and the ECG data to a patient record (mental processes).
Regarding claims 7 and 17, wherein the GUI further comprises an indication of the interpretation (mental processes).
Regarding claims 8 and 18, wherein the patient data comprises date of birth, height, weight, sex, other health conditions, and previous ECG data (mental processes).
Regarding claim 9, wherein the cloud analysis platform is further to: provide a portal through which patient records can be accessed (mental processes).
Regarding claims 10 and 20, wherein the ECG monitoring device further transmits a patient identifier along with the ECG data to the cloud analysis platform (mental processes).
Regarding claim 19, further comprising: accessing patient records through a portal provided by the cloud analysis platform (mental processes).
Since these claims are directed to an abstract idea, the Office must determine whether the remaining limitations “do significantly more” than describe the abstract idea.
Part II. Determine whether any Element, or Combination, Amounts to“Significantly More” than the Abstract Idea itself
Under Part II, the steps of the claims, when considered individually and as an ordered combination, do not improve another technology or technical field, do not improve the functioning of the computer itself, and are not enough to qualify as "significantly more". For example, the steps require no more than a conventional computer to perform generic computer functions. As stated above in Prong Two, the ECG monitoring device and computing device in the steps are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component. Therefore, based on the two-part Mayo analysis, there are no meaningful limitations in the claim that transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself. Claims 1-20, when considered individually and as an ordered combination, are rejected as ineligible subject matter under 35 U.S.C. 101.
Dependent claims 2-10 and 12-20 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additional claims do no recite significantly more than an abstract idea.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kozmann et al. (US 2020/0282262 A1)
Coudere et al. (US 10,555,702 B1)
The prior art reference teach an electrocardiogram (ECG) monitoring device to: measure an ECG of a user to generate ECG data; and transmit the ECG data; a computing device to: receive the QT analysis results; and provide a graphical user interface (GUI) to visualize the ECG data with the QT analysis results integrated therein. However, the references do not teach or suggest that the QT analysis and interpretation is conducted on a cloud analysis platform as recited in claims 1, 5, 6, 9, 10, 11, 15, 16, 19, and 20 . The references merely states that ECG signal data can be stored in cloud data storage or that QT analysis can be conducted to find the QT interval without the detail (such as the cloud analysis platform and interpreting the ECG results) as recited in the claims.
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/CHINYERE MPAMUGO/Primary Examiner, Art Unit 3685