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 1-11 and 13-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) the mental concept of receiving values, conditions, and physiological data to compare the data to first and second conditions to determine onset and termination of an arrhythmia, to further detect an arrhythmia episode based on the duration from onset to termination for outputting the detected episode. This judicial exception is not integrated into a practical application because the combination of additional elements (e.g. detector/processor, and output in claim 1, implantable monitor in claim 11, etc.) fails to integrate the judicial exception into a practical application. The generally recited computer elements (e.g. detector/processor and output, etc.) do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract on a computer. In addition, for claim 11, the implantable monitor is just a housing for the claimed computer and performs no other function and is nothing more than an attempt to generally link the product to a particular technological environment. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered separately and in combination do not add significantly more to the exception. The additional limitations only calculate/determine and output data and these are well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP 2106.05.
The claims are directed to an abstract idea and/or the end result of the system/method, the essence of the whole, is a patent-ineligible concept. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they amount to a general computer performing a calculation. The claims are directed to an abstract idea, i.e. implementing the idea of receiving values, conditions, and physiological data to compare the data to first and second conditions to determine onset and termination of an arrhythmia, to further detect an arrhythmia episode based on the duration from onset to termination for outputting the detected episode, such as may be done by a mental process, critical thinking, and/or paper and pencil, or done by a mathematical equation, with additional generic computer elements, or additional structure (e.g. detector/processor, output, cardiac monitor in claim 11, etc.) recited at a high level of generality that perform generic functions routinely used in the art, and do not add a meaningful limitation to the abstract idea because they would be routine in any computer implementation or in the relevant art. Thus, the recited generic computer components perform no more than their basic computer functions. These additional elements are well‐understood, routine and conventional limitations (see cited document(s)) that amount to mere instructions or elements to implement the abstract idea. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. See the recent decisions by the U.S. Supreme Court, including Alice Corp., Myriad, and Mayo. In addition, the current claims are similar to other recent court decisions dealing with analyzing, comparing, and/or displaying data, such as Electric Power Group, Digitech, Grams, and Classen.
Based on the plain meaning of the words in the claim, the broadest reasonable interpretation of the claims (e.g. claim 1 having an output and detector/processor, and corresponding method claim 13) is a system having a processor, wherein the processor is programmed with executable instructions to perform the calculations/mental process/critical thinking. The claims do not impose any limits on how the physiological information is received by the processor, and thus this step covers any and all possible ways in which this can be done, for instance by typing the information into the system, or by the system obtaining the information from another device. The claim also does not impose any limits on how the computations are accomplished, and thus it can be performed in any way known to those of ordinary skill in the art.
The calculations are simple enough to be practically performed in the human mind or through critical thinking. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. Nor does the recitation of a processor in the claim negate the mental nature of this limitation because the claim here merely uses the processor as a tool to perform the otherwise mental process.
The output and processor are recited so generically (no details whatsoever are provided other than that they are an output and processor) that they represent no more than mere instructions to apply the judicial exception on a computer. These limitations can also be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer. It should be noted that because the courts have made it clear that mere physicality or tangibility of an additional element or elements is not a relevant consideration in the eligibility analysis, the physical nature of these computer components does not affect this analysis. See MPEP 2106.05(I) for more information on this point, including explanations from judicial decisions including Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224-26 (2014).
Although the processor or claim limitations may fall under several exceptions (e.g., a mathematical concept-type abstract idea or a mental process-type abstract idea), there are no bright lines between the types of exceptions. See, e.g., MPEP 2106.04(I). Thus, it is sufficient for the examiner to identify that the limitations align with at least one judicial exception, and to conduct further analysis based on that identification.
The limitations of the claims are carried out by the processor and the output. No element has been set forth to sense the physiological signal, and the only additional element is the output, where the processor performs the necessary software tasks so that the result of the abstract mental process is just data/arrhythmia episode data. The output limitation represents extra-solution activity because it is a mere nominal or tangential addition to the claim. Similarly, for claim 11, the implantable monitor represents just a housing for the processor. See MPEP 2106.05(g), discussing limitations that the Federal Circuit has considered to be insignificant extra-solution activity. Even when viewed in combination, the additional elements in this claim do no more than automate the mental processes (e.g., the mental computation of receiving values, conditions, and physiological data to compare the data to first and second conditions to determine onset and termination of an arrhythmia, to further detect an arrhythmia episode based on the duration from onset to termination for outputting the detected episode, etc.), using the computer components as a tool. While this type of automation may improve the life of a practitioner/physician (by minimizing or eliminating the need for mentally computing metrics), there is no change to the computers and other technology that are recited in the claim as automating the abstract ideas, and thus this claim cannot improve computer functionality or other technology. See, e.g., Trading Technologies Int’l v. IBG, Inc., 921 F.3d 1084, 1093 (Fed. Cir. 2019) (using a computer to provide a trader with more information to facilitate market trades improved the business process of market trading, but not the computer) and the cases discussed in MPEP 2106.05(a)(I), particularly FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1095 (Fed. Cir. 2016) (accelerating a process of analyzing audit log data is not an improvement when the increased speed comes solely from the capabilities of a general-purpose computer) and Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055 (Fed. Cir. 2017) (using a generic computer to automate a process of applying to finance a purchase is not an improvement to the computer’s functionality). Accordingly, the claim as a whole does not integrate the recited judicial exception into a practical application and the claim is directed to the judicial exception.
Allowable Subject Matter
Claims 12 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 9/9/25 have been fully considered but they are not persuasive. The argument that the current claims contain similar limitations to claim 1 of the CardioNet Federal Circuit decision and therefore the 101 rejection should be withdrawn is not persuasive for several reasons.
The claims in the CardioNet case are very different than the current claims. Claim 1 in CardioNet contains 5 different elements that cooperate together—beat detector, ventricular beat detector, variability logic, relevance logic and an event generator. The current claims only contain 2 elements, an arrhythmia detector and an output of the detector.
The arguments, claims, and analysis in CardioNet is different than the current application and therefore while CardioNet’s claims are allowable, that does not mean the current application and claims are allowable, have the same arguments, and/or analysis.
The claimed “arrhythmia detector circuit” is just a general purpose processor/computer with a claimed output –i.e. a port to output results/data. This can be seen in paragraph 81 of the specification “[I]n various examples, portions of the functions of the ventricular beat analyzer circuit 220, the arrhythmia detector circuit 230, and the control circuit 240 may be implemented as a part of a microprocessor circuit. The microprocessor circuit may be a dedicated processor such as a digital signal processor, application specific integrated circuit (ASIC), microprocessor, or other type of processor for processing information including the physiologic signals received from the sensor circuit 210. Alternatively, the microprocessor circuit may be a general-purpose processor that may receive and execute a set of instructions of performing the functions, methods, or techniques described herein”.
Therefore, claim 1 basically is a general purpose computer performing calculations on data to output a result. Note that no element has been set forth to sense the physiological information and nothing is done with the result except outputting it.
The argument that the claims provide an improvement by aggregating multiple short arrhythmia episodes into a single longer episode, reducing memory usage, and lowers the burdens on clinicians who must review detected episodes is not persuasive. The claims do not reflect the asserted improvements. In addition, the judicial exception alone cannot provide the improvement. As set forth, the claims are directed to a “general purpose processor” performing calculations and outputting the result and it is unclear how this general purpose processor provides the argued improvements. It must be noted that almost every patent is an improvement on what has been previously done as it provides a better, cheaper, stronger, faster, etc. improvement.
Conclusion
Applicant's amendment necessitated the updated/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 George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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/George R Evanisko/ Primary Examiner, Art Unit 3792 12/11/25