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 .
Response to Arguments
Applicant's arguments and amendments regarding the 101 rejection filed 10/14/2025 have been fully considered but they are not persuasive. The Applicant argued that there are no abstract ideas since the processing is based on a computer device and cannot be practically performed in the mind. The Examiner respectfully disagrees. To reiterate, the prediction of a cardiac dysfunction is something a doctor can do in the mind by observing and analyzing data followed by making a determination for a diagnosis. The claims recite merely using a generic computer (eg. Applicant’s specification, Para. 18, 58) as a tool to perform the mental process, which does not integrate the abstract idea into a practical application (See MPEP 2106.04(d) and 2106.05(f)). Even if the technological improvement is within the prediction, 36. Genetic Technologies Limited v. Merial LLC (Fed Cir., 2016) tells us that the inventive concept of step 2 of the Alice/Mayo analysis cannot be supplied by the abstract idea. The inventive concept necessary at step two of the Mayo/Alice analysis cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself. That is, under the Mayo/Alice framework, a claim directed to a newly discovered law of nature (or natural phenomenon or abstract idea) cannot rely on the novelty of that discovery for the inventive concept necessary for patent eligibility; instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity.” Mayo, 132 S. Ct. at 1294; see also Myriad, 133 S. Ct. at 2117; Ariosa, 788 F.3d at 1379. The Examiner recommends adding limitations that would improve the technology of the computer. The 101 rejection is maintained below.
Applicant’s arguments and amendments, see pages 10-14, filed 10/14/2025, with respect to the rejection(s) of claim(s) 1, 3-14, 16-17, and 20 under USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Miao (US 2018/0279891 A1) in view of Shadforth (US 2022/0095955 A1).
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 of the following analysis:
Step 1: Do the claims recite one of the statutory categories of matter (i.e. method, apparatus, etc.)? YES, Claims 1-15 recite a method and claims 16-20 recite apparatuses.
Step 2A Prong 1: Is there an abstract idea involved? YES, the claim language recites generating a cardiac dysfunction prediction for the user (analysis/determination). These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper.
Step 2a Prong 2: Do the claims recite additional elements that integrate the exception into a practical application? NO, the claims recite a sensor, a computing device, and an annunciator. The computing device and annunciator (such as a display) are recited at a high level of generality and is recited as performing generic computer functions. i.e., data processing and display. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea. The sensor is generically recited and wouldn’t amount to more than an extrasolution activity of necessary data gathering (MPEP 2106.05(g)).
The dependent claims recite the same abstract idea as the independent claims. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process. The elements are recited at a high level of generality and is recited as performing generic computer functions. i.e., data processing and display. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)).
Step 2B: Do the additional elements amount to “Significantly More” than the judicial exception? NO, the emphasized elements cited above do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in 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 in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. 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)).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3, 5, 7-11, 13-14, 16-17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miao (US 2018/0279891 A1) in view of Shadforth (US 2022/0095955 A1).
Regarding claims 1, 16, and 20, Miao discloses computer-implemented method for detecting a cardiac dysfunction in a user (eg. Abstract, multiple embodiments Para. 29, 33, 52 77-78 using PPG and a combination of PPG and ECG), the method comprising: obtaining, from a sensor, photoplethysmogram (PPG) signals indicative of a cardiac rhythm of the user (eg. Para. 9-10, Fig. 2, sensor 152, Para. 43); processing, in a computing device (eg. Para. 10-11, 42-45, Fig. 2, processor 130), the PPG signals to generate a cardiac dysfunction prediction for the user based, at least in part, on the PPG signals (eg. Abstract, 47, 70-73, claims 1-2, machine learning Abstract, Para. 9-11, 41, 70, 72); and providing, via an annunciator, the cardiac dysfunction prediction for the user as an output (eg. Abstract, Par. 9-10, 36-38, 42, 48-49, Fig. 2, display 180). Miao does not disclose machine learning models to generate LVSD predictions from PPG.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used multiple sensors such as ECG and PPG to improve detection accuracy (eg. Para. 33).
Shadforth teaches a sensor device with a machine learning algorithm (eg. Para. 7, 72, 87, 181) that uses PPG signals (eg. Para. 18) to determine left ventricular function such as left ventricular end-diastolic pressure (eg. Para. 34-35, 74, 87, 114, 181-183) and displays the report on a screen (eg. Para. 20, 36-37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Miao with the machine learning algorithm for detecting LVEDP as taught by Shadforth to provide the predictable result of improving detection of heart failure (eg. Shadforth, Para. 4, 9).
Regarding claims 3 and 17, the combined invention of Miao and Shadforth discloses obtaining, via the computing device, electrocardiogram (ECG) signals indicative of the cardiac rhythm of the user; processing, via the one or more machine-learned models, the PPG signals and the ECG signals to generate the cardiac dysfunction prediction for the user (eg. Para. 33, 52, 77-78, Claim 11).
Regarding claim 5, The combined invention of Miao and Shadforth discloses the one or more machine-learned models are further configured to process demographic data relating to the user to generate the cardiac dysfunction prediction for the user (eg. Para. 70-72).
Regarding claim 7, The combined invention of Miao and Shadforth discloses the one or more machine-learned models comprise a deep learning model (Eg. Para. 70-72, decision tree).
Regarding claim 8, The combined invention of Miao and Shadforth discloses he cardiac dysfunction prediction for the user comprises one or more predicted probabilities that the user is experiencing the cardiac dysfunction (eg. Para. 41, 47, Claims 12-13).
Regarding claim 9, The combined invention of Miao and Shadforth discloses obtaining the PPG signals comprises: obtaining, via one or more biometric sensors of a wearable computing device, PPG signals indicative of the cardiac rhythm of the user (eg. Abstract, Para. 9-10, 36-40, wearable device 100 and 152 PPG sensor provides cardiac rhythm data).
Regarding claim 10, The combined invention of Miao and Shadforth discloses the one or more biometric sensors comprise one or more PPG sensors (eg. Abstract, Para. 9-10, 36-40 PPG sensor 152).
Regarding claim 11, The combined invention of Miao and Shadforth discloses obtaining PPG signals comprises: obtaining, via one or more pulse oximeters, PPG signals indicative of the cardiac rhythm of the user (eg. Abstract, Para. 9-10, 29, 36-40 PPG sensor 152).
Regarding claim 13, The combined invention of Miao and Shadforth discloses surfacing, via the computing device, a notification to the user indicative of the cardiac dysfunction prediction via a user interface of a wearable computing device (eg. Para. 9, 36-42, 48-49 Fig. 1, display 160, Fig. 2, display 180).
Regarding claims 14, The combined invention of Miao and Shadforth discloses surfacing a notification to the user indicative of the cardiac dysfunction prediction further comprises: surfacing, via the computing device, a recommendation to the user to wear an ECG monitor in response to generating the cardiac dysfunction prediction (eg. Shadforth, Para. 20, 36-37).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miao (US 2018/0279891 A1) in view of Shadforth (US 2022/0095955 A1), further in view of Datta (US 2022/0296165 A1).
Regarding claim 4, The combined invention of Miao and Shadforth discloses the invention of claim 1, but does not disclose ECG signals are obtained via a single-lead electrocardiogram.
Datta teaches a wearable sensor monitoring device that uses single lead ECGs (eg. Para. 150-152) and PPG (eg. Para. 53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Miao and Shadforth with the single lead ECG as taught by Datta because single lead ECGs are common types of ECG in the art.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miao (US 2018/0279891 A1) in view of Shadforth (US 2022/0095955 A1), further in view of Stump (US 2021/0000347 A1).
Regarding claim 6, The combined invention of Miao and Shadforth discloses the one or more machine-learned models are trained with PPG data and demographic data (eg. Para. 70-72), but not ECG data.
Stump teaches a patient monitoring device that utilizes machine learning using ECG, PPG, and population correlation data (eg. Para. 160, 170).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Miao and Shadforth to have the machine learning use ECG, PPG, and demographic data as taught by Stump to provide the predictable result of having more accurate diagnoses.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miao (US 2018/0279891 A1) in view of Shadforth (US 2022/0095955 A1), further in view of Peters (US 2023/0200664 A1).
Regarding claim 12, The combined invention of Miao and Shadforth discloses the invention of claim 1, but does not disclose obtaining PPG signals comprises: obtaining, via one or more cameras of a mobile computing device, PPG signals indicative of the cardiac rhythm of the user.
Peters teaches a mobile device that uses a camera for collecting PPG data (eg. Fig. 14, camera sensor 1412, Para. 253, 264, claim 105).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the ppg sensor of Miao and Shadforth to be a camera sensors as taught by Peters because camera sensor PPGs are a known equivalent substitute in the art.
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 MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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/MICHAEL J LAU/Examiner, Art Unit 3796