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 .
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on December 16, 2025 has been entered. By this amendment, claims 1, 9, 14, and 22 are amended and claims 1-9, 11-22, and 24-26 are now pending in the application.
Specification
The amendment filed December 16, 2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the amendments to claims 9 and 22 to add the language “wherein the 10% decline threshold corresponds to a monitoring threshold value associated with patient drug regimens including mavacamten and heart failure treatment drugs”.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The newly-added limitation “wherein the 10% decline threshold corresponds to a monitoring threshold value associated with patient drug regimens including mavacamten and heart failure treatment drugs” is not supported by the originally-filed disclosure. Although mavacamten and heart failure treatment drugs are recited in the original specification at paragraph [0045], there is no disclosure which connects such treatment to the 10% decline threshold or a monitoring threshold value associated with these drug regimens.
Allowable Subject Matter
Claims 1-8, 11-21, and 24-26 are allowed.
The following is an examiner’s statement of reasons for allowance: It is in the opinion of the examiner that the art of record neither anticipates nor renders obvious “receive, by the at least one processor, a training dataset, wherein the training dataset comprises a plurality of example ECG data correlated to a plurality of example LVEF levels; sanitize, by the at least one processor, the training dataset, wherein sanitizing the training dataset comprises: determining, by the at least one processor, that at least one training dataset entry of the training dataset has a signal to noise ratio below a threshold value; and removing, by the at least one processor, the at least one training dataset entry from the training dataset to create a sanitized training dataset; train, by the at least one processor, the LVEF prediction model by :receiving the sanitized training dataset; and training the LVEF prediction model using the sanitized training dataset; retrain, iteratively, by the at least one processor, the LVEF prediction model with feedback from previous iterations of the LVEF prediction model; input, by the at least one processor, the first ECG datum into the retrained LVEF prediction model; and generate, by the at least one processor, a first LVEF prediction comprising a confidence metric using the retrained LVEF prediction model” in combination with the rest of the claimed limitations set forth in the independent claim.
Searching by the Examiner yielded prior art as cited in the previous Office Actions. Based on Applicant’s arguments and the Examiner’s review of the Office Action mailed on January 28, 2025, the subject matter is deemed to be allowable. Further explanation can be reviewed in the Applicant’s arguments filed on April 17, 2025 and December 16, 2025. Therefore, it is concluded by the examiner that claims 1-8, 11-21, and 24-26 of the present invention are allowable.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796