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 amendment and arguments filed 1/16/2026 have been fully considered but they are not persuasive. Applicant argues that the additional element of “cause a monitor to display a symbol indicating the occurrence of the pacing tachycardia or spontaneous tachycardia base don a result of the determination of the processor” “is not merely an ornamental add-on but rather it is the analyzer’s operational endpoint that encodes and conveys the determined outcome in real time, thereby providing meaningful limitations on the alleged abstract idea”. The Examiner respectfully disagrees. The limitation of displaying a symbol as a result of the processor determination is a form of data output, particularly outputting the result of the determination. This has been help to be insignificant, extra-solution activity (see MPEP §2106.05(g)) and thus would fail to integrate the abstract idea into a practical application. The rejection is therefore 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, 2, 4-6 and 8-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) determining whether detected heartbeats are paced beats and providing a notification when the identified paced beats are indicative of a tachycardia.
Step 1
Claims 1 and 10 are drawn to “a heartbeat analyzer”, i.e. a machine.
Step 2A, Prong 1
Claims 1 and 10 recite an Abstract Idea. Particularly, the claims recite the limitations of determining whether the heartbeats are paced beats; determining the kind of paced beats based on relative detection timings of heartbeats; determining that pacing tachycardia is present based on the occurrence of paced beats and the ratio of occurrence of paced beats; and providing a notification when a paced tachycardia is determined or a spontaneous tachycardia is determined, as drafted, are processes that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, the determining steps in the context of this claim encompasses the user viewing an ECG printout on paper or a screen and making mental determinations/counts of QRS peaks in a limited window (such as seconds or minutes) to determine if tachycardia is present and ultimately indicating via writing on paper, verbal communication, etc. the mentally determined result. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea
Step 2A, Prong 2
The claims do not recite any additional elements that integrate the judicial exception into a practical application. In particular, the steps of detecting heartbeats from a differential electrical signal from a plurality of electrodes placed on a living body and detecting outputs of pacing pulses amount to insignificant pre-solution activity of data gathering. Additionally, the claim only recites the additional elements of a memory, generic processor (and the digital aspect of processor implementation) and potentially a display for notification. The memory, processor (including the digital nature of processors) and display are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of ranking information based on a determined amount of use) such that they amount to no more than mere instructions to apply the exception using a generic computer component. Lastly, the step of “cause a monitor to display a symbol indicating the occurrence of the pacing tachycardia or spontaneous tachycardia base don a result of the determination of the processor” is a form of data output, particularly outputting the result of the determination. This has been help to be insignificant, extra-solution activity (see MPEP §2106.05(g)) and thus would fail to integrate the abstract idea into a practical application. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B
The claims do not recite additional elements that amount to significantly more than the abstract idea itself. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of memory, a processor (and the digital nature of a processor) and a display amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Furthermore, the step of “cause a monitor to display a symbol indicating the occurrence of the pacing tachycardia or spontaneous tachycardia base don a result of the determination of the processor” is a form of data output, particularly outputting the result of the determination. This has been help to be insignificant, extra-solution activity (see MPEP §2106.05(g)) and thus would fail to amount to, alone or in combination with the other features, significantly more than the abstract idea itself. Additionally, the pre-solution steps of obtaining heartbeat electrical activity from differential electrical signals that contain intrinsic and pacing pulses therein is well-understood, routine and conventional activity in heart diagnostic and pacing systems. This is generally the basis for which cardiac electrical diagnostic systems from. See Zhu et al. (2002/0120306), par. [0031]; Levine et al. (2002/0143367), par. [0075]; Koestner et al. (5,300,093), col. 24, lines 35-55; Palreddy et al. (2004/0106957), par. [0013]; Corbucci (2007/0073346), par. [0004]). The Examiner additionally notes that ECG leads, namely bipolar leads I, II and III are defined as differential electrical signals between two electrodes, see Dupre et al., Ch. 15 “Basic ECG Theory, Recordings and Interpretation” from the “Handbook of Cardiac Anatomy, Physiology, and Devices”, pp. 191-201 with particular note to p. 193, “3. Measuring the ECG”. The claim is not patent eligible.
Claims 2, 4-6 and 11-12 are rejected for the same reasons above as well as only including limitations that only relate to the abstract idea identified in Claims 1 and 10.
Claims 13 and 14 introduce a time scale that only further defines the abstract idea. The time values claimed do not pertain to the speed at which a decision is made or the data is processed and instead relates to a timing of a pacing pulse relative to a QRS wave. The assessment of data on this small time scale could still be practically performed in the human mind. Specifically, data could be presented to a user with a small time scale (such as a graph with 0.05 second per grid) and then a clinician could determine whether the beat is within 0.2 seconds of another through easy visual inspection. Fig. 3 is an example of this type of zoomed in graph where pacing pulses P are easily visually distinguishable from spontaneous beats S.
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.
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/ALLEN PORTER/ Primary Examiner, Art Unit 3796