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 .
This Office Action is responsive to the Amendment filed 06 January 2026. Claims 1-14, 16, and 17 are currently under consideration. The Office acknowledges the amendments to claims 1, 2, 10, 13, and 16, as well as the cancelation of claim 15.
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 9: “the electrical signals” should apparently read --the plurality of electrical signals--.
In line 14: there should apparently be a semi-colon at the end of the line (following “the signal data”).
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-13, 16, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haeusser et al. (U.S. Pub. No. 2020/0245885 A1; hereinafter known as “Haeusser”).
Regarding claim 1, Haeusser discloses a system (Abstract; Figs. 1, 12) comprising: a body surface device 420 carrying a plurality of electrodes 430 configured to be in contact with a body surface of a subject, the plurality of electrodes configured to cover one or more areas on the body surface, wherein the plurality of electrodes are configured to detect a plurality of electrical signals generated by the heart of the subject, wherein the body surface device is configured to record from an area of less than one half of a torso surface of the subject ([0217]-[0223]; e.g., in Fig. 12(b), only an upper half of the vest is used; the electrodes may be only on the anterior side of the vest; the electrodes do not cover the full surface of the vest; thus, clearly the body surface device records from less than half of the torso surface of the subject); and a computing device 300 configured to receive signal data of the electrical signals generated from the body surface device, the computing device comprising a processor and memory, the memory storing instructions, the instructions, when executed by the processor, causing the processor to perform operations ([0056]; [0080]-[0086]) comprising: determining one or more locations of the heart that are associated with a heart rhythm disorder based on the signal data ([0225]; [0233]); extracting features from the detected electrical signals and the determined one or more locations and inputting the features into a machine learning model that is trained based on population-level outcomes of other patients to specific treatments ([0016]-[0017]; [0232]; [0244]; [0249]-[0256]) and computing, based on the machine learning model, a predicted success score that the subject will benefit from a planned therapy for the heart rhythm disorder ([0265]; [0267]; predict that the patient has a substantial probability of successful treatment with pulmonary vein isolation and/or atrial ablation).
Regarding claim 2, Haeusser discloses that the operations performed by the processor further comprise computing the predicted success score for the planned therapy for eliminating one or more regions that initiate an onset of the heart rhythm disorder or regions that maintain the heart rhythm disorder ([0265]; [0267]; predict that the patient has a substantial probability of successful treatment with pulmonary vein isolation and/or atrial ablation).
Regarding claim 3, Haeusser discloses that the planned therapy targets pulmonary veins ([0265]; [0267]; pulmonary vein isolation).
Regarding claim 4, Haeusser discloses that the planned therapy targets regions are in the left side or right side of the heart ([0265]; [0267]).
Regarding claim 5, Haeusser discloses that the heart rhythm disorder is atrial fibrillation ([0244]).
Regarding claim 6, Haeusser discloses that the operations performed by the processor further comprise guiding a probe towards one of the locations of the heart that are associated with the heart rhythm disorder ([0062]; [0066]; [0225]).
Regarding claim 7, Haeusser discloses that the probe contains sensors for recording ([0062]).
Regarding claim 8, Haeusser discloses that the probe is capable of delivering energy to modify tissue regions related to the heart rhythm disorder ([0071]).
Regarding claim 9, Haeusser discloses that the computing device is a computing server that is geographically remote from the body surface device ([0058]; [0084]; [0227]; [0262]).
Regarding claim 10, Haeusser discloses that the body surface device further comprises a substrate that comprises one or more regions, each region configured to be in contact with one of torso quadrants of the subject, the torso quadrants being a right anterior, a left anterior, a left posterior, and a right posterior (Fig. 12; [0218]-[0223]).
Regarding claim 11, Haeusser discloses that determining the one or more locations of the heart that are associated with the heart rhythm disorder comprises a phase analysis, an analysis of spatial patterns of electrical activation over time, a vectorial analysis, a spectral analysis, and/or signal featurization ([0243]-[0246]; [0256]; [0265]).
Regarding claim 12, Haeusser discloses that determining the one or more locations of the heart that are associated with the heart rhythm disorder comprises determining whether one of the locations is the left atrium, the right atrium, the left ventricle, or the right ventricle of the heart of the subject ([0052]; [0232]-[0233]; [0265]).
Regarding claim 13, Haeusser discloses that determining one or more locations of the heart that are associated with the heart rhythm disorder comprises inputting a version of the signal data to the machine learning model to determine one of the locations, the machine learning model is iteratively trained based on training samples of data associated with known heart rhythm disorders ([0016]-[0017]; [0232]; [0244]; [0249]).
Regarding claim 16, Haeusser discloses that the one or more locations of the heart that are associated with the heart rhythm disorder comprise a location of a beat that initiates onset of a heart rhythm disorder, and/or a location of a source region of the heart rhythm disorder ([0065]; [0232]-[0233]).
Regarding claim 17, Haeusser discloses that the body surface device is wearable during daily activities of the subject ([0217]; wearable vest).
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.
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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Haeusser as applied to claim 13 above, and further in view of Cahan et al. (U.S. Pub. No. 2017/0224279 A1; hereinafter known as “Cahan”). Haeusser discloses the invention as claimed, see rejection supra, but fails to disclose that the operations performed by the processor further comprise calculating a cardiac output, determining if the cardiac output is reduced, and sending an alert that the cardiac output is reduced. Cahan discloses a similar system (Abstract), wherein atrial fibrillation may reduce cardiac output ([0008]), and wherein operations performed include calculating a cardiac output, determining if the cardiac output is reduced, and sending an alert that the cardiac output is reduced, in order to guide diagnosis and treatment ([0027]; [0061]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Haeusser by calculating a cardiac output, determining if the cardiac output is reduced, and sending an alert that the cardiac output is reduced, as taught by Cahan, in order to guide diagnosis and treatment in such a situation as atrial fibrillation.
Response to Arguments
Applicant’s arguments with respect to the claim objections and the rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive in light of the amendments. The objections and rejections have been withdrawn.
Applicant's arguments with respect to the rejections under 35 U.S.C. 102 and 103 have been fully considered but they are not persuasive. Applicant argues that the amended claims are distinguished from the prior art by certain recitations and improvements. However, Applicant does not make any arguments regarding Haeusser (or Cahan). As detailed supra, Haeusser does still anticipate most of the claims, as it recites such a trained machine learning model, as well as making predictions that the patient has a substantial probability of being successfully treated with certain planned therapies.
Conclusion
THIS ACTION IS MADE FINAL. 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 THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M. Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791