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 in combination with amendments, see Remarks and Claims, filed 04/27/2026, with respect to the rejection(s) of claim(s) under 35 USC 102 and 103 have been fully considered but they are not persuasive. The applicant argues that the limitations cannot be performed in mind. This argument is fully considered but is not persuasive. The claim as written does not provide any details requiring the specific time, number of data points, etc. to be assessed. As stated, a PHOSITA could view, identify beats, compare the identified beats with nearby beats, and determine an area between the identified beat and each nearby beat, and mark the nearby beat as representing premature ventricular contraction if a threshold is satisfied. These steps are mere observation, evaluation, judgment, opinion which are concepts performed in the human mind.
The limitation “run detection for premature ventricular contraction and identify one or more beats as representing premature ventricular contraction” similarly falls under observation, evaluation, judgment, opinion which are concepts performed in the human mind.
Applicant’s arguments in combination with amendments, see Remarks and Claims, filed 04/27/2026, with respect to the rejection(s) of claim(s) under 35 USC 102 and 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 Therefore, the rejection has been withdrawn.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 the following. See details below.
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.
Claims 1-7, 9-17, 19-20 are rejected under 35 U.S.C. 101 because of the following analysis:
1 – statutory category: Claims 1-7, 9 recite a system, and therefore, falls under the statutory category of being a thing or products. See MPEP 2106.03. Claims 10-17, 19-20 recite a series of steps and therefore, falls under the statutory category of being a process. See MPEP 2106.03.
2A – Prong 1: The independent claims 1 and 11 recite a judicial exception by reciting the limitations of “:identify beats from the cardiac data; run detection for premature ventricular contractions and identify one or more beats as representing premature ventricular contractions by establishing an average heart rate of the patient by computing all beat times for heart beats over narrow windows of heart beat data, comparing individual heart beats with the average heart rate, and identifying any individual heart beats that occur earlier than the average as premature; compare at least one of the identified beats with each of a plurality of nearby beats by lining up the nearby beat and the identified beat; determine an area between the identified beat and each nearby beat; and mark at least one of the nearby beats as representing premature ventricular contraction when the area between that nearby beat and the identified beat satisfies a threshold level of similarity”. 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. Therefore, an abstract idea is involved.
2A – Prong 2: The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The independent claims 1 and 11 recite the additional limitations of “database”, “a cardiac monitor”, “a mobile application running on a mobile device associated with a patient”, “a server”, “a central processing unit, memory”, etc. The mentioned limitations are recited at a high level of generality and are considered to be data gathering/processing which are mere extra-solution activity. 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.
2B: 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)).
Claims 2-7, 9-10 and 12-17, 19-20 depend on claims 1 and 11. The mentioned 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). For example, the dependent claim recites the limitations “mobile cardiac telemetry”, “cutaneous monitor placed on skin of the patient or an implantable monitor”, “wireless transceiver”, “Bluetooth chip”, “electrocardiography patch, an externally-powered micro- controller, and an electrocardiographic front end circuit”, etc., are recited at a high level of generality and are mere extra-solution activity, and recited as performing generic computer functions. i.e., data processing. 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)).
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.
Thus, claims 1-7, 9-17, 19-20 are directed to an abstract idea and are therefore rejected.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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) 1-5, 7, 9-15, 17, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP4039191A1 to Yun Qiao et al. (hereinafter “Yun” – on IDS) in view of US 20120277609 to Schneider et al. (hereinafter “Schneider” – on IDS).
Regarding claims 1 and 11. Yun discloses a system for beat-based arrhythmia detection (abstract, para 0026, etc. “system”), comprising: a database to store cardiac data (abstract, para 0007, 0019, 0028, fig. 2 “memory”); a cardiac monitor to continuously transmit the cardiac data collected to the database via a mobile application running on a mobile device associated with a patient (para 0019, 0044 “communication link”); and a server comprising a central processing unit, memory, an input port, and an output port, wherein the central processing unit is (para 0019) configured to: identify beats from the cardiac data; run detection for premature ventricular contractions (para 0023) and identify one or more beats as representing premature ventricular contractions (para 0023); compare at least one of the identified beats with each of a plurality of nearby beats by lining up the nearby beat and the identified beat (para 0025 discussing the algorithm maintaining rolling buffer “the pre and post-PVC intervals are excluded from the RRI rolling buffer. The morphology rolling buffer includes electrograms (EGMs) associated with the last three intrinsic beat. In one example, the EGM of each beat is obtained from 20ms before the VS marker to 180ms after the VS marker for a toral duration of 200ms. The intrinsic EGMs stored in the morphology rolling buffer function as templates for comparison”); determine an area between the identified beat and each nearby beat (para 0057 comparing areas of different beats); and mark at least one of the nearby beats as representing premature ventricular contraction when the area between that nearby beat and the identified beat satisfies a threshold level of similarity (fig. 3, para 0054, step 308, para 0063 step 318).
Yun discloses determining a threshold related to the series of beats but fails to explicitly disclose comparing individual heart beats with the average heart rate, and identifying any individual heart beats that occur earlier than the average as premature.
Schneider from a similar field of endeavor teaches determining average, median, nth maximum area or other statistical measure for the N preceeding beats (para 0039) and determining reference RR interval as a running average (para 0043) wherein current RR interval is compared to a prematurity threshold for determining whether a PVC coupling interval is detected (para 0044). ). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Yun with the teachings of Schneider to provide the predictable result of determining prematurity.
Regarding claims 2 and 12. Yun as modified by Schneider renders obvious the system for beat-based arrhythmia detection according to Claim 1, wherein the cardiac data is transmitted from the cardiac monitor using mobile cardiac telemetry (para 0019).
Regarding claims 3 and 13. Yun as modified by Schneider renders obvious the system for beat-based arrhythmia detection according to Claim 1, wherein the cardiac monitor comprises a cutaneous monitor placed on skin of the patient or an implantable monitor (para 0026 “ICM 100 intended for subcutaneous implantation”).
Regarding claims 4 and 14. Yun as modified by Schneider renders obvious the system for beat-based arrhythmia detection according to Claim 1, wherein the cardiac data is transmitted from the cardiac monitor via a wireless transceiver (para 0019, 0026).
Regarding claims 5 and 15. Yun as modified by Schneider renders obvious the system for beat-based arrhythmia detection according to Claim 4, wherein the wireless transceiver comprises a Bluetooth chip (para 0026 “Bluetooth”).
Regarding claims 7 and 17. Yun as modified by Schneider renders obvious the system for beat-based arrhythmia detection according to Claim 1, wherein the nearby beat and the identified beat are lined up based on one of start time and stop time, and shape (para 0025 “device algorithm also accounts for normal fluctuations in heart rate due to activity and circadian rhythm by maintaining an RRI rolling buffer and a morphology rolling buffer consisting of intrinsic beat that are updated in a first-in first-out manner with every beat. The RRI rolling buffer can include three intrinsic RRI values. In other words, the pre and post-PVC intervals are excluded from the RRI rolling buffer. The morphology rolling buffer includes electrograms (EGMs) associated with the last three intrinsic beat. In one example, the EGM of each beat is obtained from 20ms before the VS marker to 180ms after the VS marker for a toral duration of 200ms. The intrinsic EGMs stored in the morphology rolling buffer function as templates for comparison with premature beats.”).
Regarding claims 9 and 19. Yun as modified by Schneider renders obvious the system for beat-based arrhythmia detection according to Claim 1, wherein the central processing unit performs arrhythmia detection on the premature ventricular contraction beats and the cardiac data (para 0028 “arrhythmia detection”).
Regarding claims 10 and 20. Yun as modified by Schneider renders obvious the system for beat-based arrhythmia detection according to Claim 9, wherein the central processing unit flags one or more segments of the cardiac data as representing a cardiac condition based on the arrhythmia detection (para 0009, 00033).
Claim(s) 6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yun as modified by Schneider, and further in view of US Pat Pub No 20190030331 to Ghosh et al. (hereinafter “Ghosh”).
Regarding claims 6 and 16. Yun as modified by Schneider renders obvious the system for beat-based arrhythmia detection according to Claim 1, wherein the cardiac monitor further comprises operable to sense electrocardiographic signals as the cardiac data and an electrocardiographic front end circuit electrically interfaced to the micro- controller (para 0016, 0026 “ECG signals collected by cutaneous electrodes”, fig 2). But fails to disclose electrocardiography patch, an externally-powered micro- controller.
Ghosh, from a similar field of endeavor teaches the electrodes to be part of a patch to be secured to the patient (para 0060). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Yun as modified by Schneider with the teachings of Ghosh to provide the predictable result of securing the electrodes to the patient.
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796
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