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 .
Continued Examination Under 37 CFR 1.114
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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 14 April 2026 has been entered. Claims 1, 4, 7-8, 11, 14 and 17-19 are pending, and claims 1, 4, 7-8, 11, 14 and 19 are amended.
Response to Arguments
Applicant's arguments filed 14 April 2026 with respect to the written description rejections under 35 U.S.C. 112 (a) have been fully considered but they are not persuasive.
The claims are amended to remove reference to the “signal quality estimation processor” and “signal analysis processor” in an attempt to overcome the lack of written description. However, these processors, which are not adequately described, are indicated as being required to determine the occurrence of at least one abnormal condition episode. Removing the processors from the claims does no resolve the lack of written description.
While the applicant amended claims 4 and 11 to include specific preset unit times that define a unit signal, these specific preset unit times do no resolve the lack of written description related to determining the occurrence of at least one abnormal condition episode.
Applicant's arguments filed 14 April 2026 with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive.
The applicant argues the analysis under Step 2A prong two is flawed in view of the recent precedential decision Ex parte Dejardins. The applicant argues the instant application integrates the judicial exception into practical application by improving computer functionality or another technology. Specifically, the distortion and overestimation of AF burden caused insufficiently short analysis. The examiner respectfully disagrees. In Dejardins, an artificial intelligence system was improved by addressing catastrophic forgetting which was an improvement in the functioning of the artificial intelligence system. In the instant application, lengthening an analysis is not an improvement in computing or technology but rather the lengthening of an analysis window i.e. the adjustment of a parameter. The analysis may be performed by the mental processing of a human and the generic/undescribed computer structure merely serves to speed the processing.
The applicant argues the Official Notice taken under Step 2B that computer processors and sensors are not well known in the art. The examiner directs the applicant to Braun et al. (US 2021/0369209), of record, which teaches known monitoring methods and products, including processors, based on PPG-dedicated algorithms are configured for distinguishing sinus (normal) rhythm episodes from AF ones [pars. 0003-0004]. Furthermore, the claims merely recite processors and sensors for performing the abstract idea without any further structural limitations.
The Affidavit submitted 14 April 2026 expresses the opinion of Chagnwoo Choi based on three prior art references relating to AF burden analysis but does not demonstrate a technological improvement that would render the claimed subject matter non-abstract.
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 1, 4, 7-8, 11, 14 and 17-19 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.
Regarding claim 1, the limitation “determining, by an episode determination processor, whether at least one abnormal condition episode has occurred and a duration time thereof” lacks sufficient description in the disclosure. In paragraph [23], the specification indicates the episode determination unit determines that an AF episode has occurred when each of biosignals of consecutive unit times of more than a preset minimum number is classified as atrial fibrillation. However, the specification does not identify the minimum number nor describe how this minimum number could be determined. Furthermore, the claim is amended to remove the limitation “based on the signal quality and abnormal signal estimation results” which does not resolve the written description issue. According the original disclose, the signal quality and abnormal signal estimation results (which were previously rejected for lack of written description) are required to perform the method. Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. In the instant application, the skilled artisan is not provided with the steps of episode determination.
Regarding claim 8, the limitation “an episode determination processor configured to determine whether an at least one abnormal condition episode has occurred and a duration time thereof” lacks sufficient description in the disclosure. In paragraph [23], the specification indicates the episode determination unit determines that an AF episode has occurred when each of biosignals of consecutive unit times of more than a preset minimum number is classified as atrial fibrillation. However, the specification does not identify the minimum number nor describe how this minimum number could be determined. Furthermore, the claim is amended to remove the limitation “based on the signal quality and abnormal signal estimation results” which does not resolve the written description issue. According the original disclose, the signal quality and abnormal signal estimation results (which were previously rejected for lack of written description) are required to perform the method. Claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. In the instant application, the skilled artisan is not provided with the steps of episode determination.
All remaining claims are rejected for depending from a claim lacking sufficient written description.
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, 3-5, 7-8, 10-12 and 14-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea, specifically a mental/mathematical process, without significantly more. The claims recite a method and device for analyzing abnormal physiological signals to determine abnormal condition burden. A physician can receive the signals on a display or print out and perform the generic steps of estimating quality, classifying as normal or abnormal, determining when an abnormal condition episode has occurred, and calculating an abnormal condition burden. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Regarding claim 1, the judicial exception is not integrated into a practical application. That is, nothing in the claim precludes the method steps from being performed in the mind. The claim recites two elements: a device for analyzing and a sensor. These elements are recited at a high-level of generality and the specification discloses a processor and a variety of sensors may be used. Thus, the processor is generic computer structure and the sensor represents mere data gathering. 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 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above the recitation of the device for analyzing and sensor for obtaining data is mere data gathering. Therefore, the limitations remain insignificant extra-solution activity, even upon reconsideration, and do not amount to significantly more. The claim is not patent eligible.
Regarding claim 8, the judicial exception is not integrated into a practical application. That is, nothing in the claim precludes the method steps from being performed in the mind. The claim recites addition processing elements: a biosignal collection unit, preprocessing unit, signal quality estimation unit, signal analysis unit, episode determination unit, and abnormal signal burden estimation unit. These elements are recited at a high-level of generality and the specification discloses a processor and a variety of biosignals may be used. Thus, the processor is generic computer structure. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they does not impose any meaningful limits on practicing the abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above the recitation of the various processing units does not add anything significant to the abstract idea, and do not amount to significantly more. The claim is not patent eligible.
Regarding claims 4, 7, 11, 14 and 17-19, the dependent claims do not add any additional elements that can be considered to constitute a practical application or to be significantly more as they merely attempt to further limit the mental process/abstract idea itself. Claim 14 recites an output unit which is a generic device that does not add anything more to the abstract idea.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN J JENNESS whose telephone number is (571)270-5055. The examiner can normally be reached M-F 8:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edward Lefkowitz can be reached at 571-272-2180. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN J JENNESS/Supervisory Patent Examiner, Art Unit 3733 3 June 2026
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