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 8-24 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) the mentally performable idea of detecting a feature point derived from an RS wave from a sampling data sequence of an electrocardiogram signal of a subject; searching for two sampling points from sampling data within a predetermined range of the feature point, wherein a product of adjacent pieces of sampling data to the two sampling points is zero or less; estimating a time at which the electrocardiogram signal becomes zero using the two sampling points; calculating an RRI based on time-series data of the time at which the electrocardiogram signal becomes zero; calculating the product of the adjacent pieces of sampling data; and comparing the product with zero. The above actions involve observation, analysis, judgement and opinion, and are therefore mentally performable.
This judicial exception is not integrated into a practical application because there are no improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a), as the detection circuit, estimation circuit and calculation circuit function in their usual capacity; there is no application or use of a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition, but only data processing – see Vanda Memo; there is no application of the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b), but only generic components; there is no transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c), but only data manipulation; and there is no application or use of the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to the particular technological environment of electrocardiogram signal processing, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP 2106.05(e) and the Vanda Memo issued in June 2018.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the detection circuit, estimation circuit and calculation circuit are generic in form and operate in their usual capacity, whether individually or in combination. The detection circuit represents insignificant data gathering necessarily required for the execution of the abstract idea. The estimation circuit and calculation circuits are insignificant as they represent mere instructions to apply the abstract idea on a generic computer functioning in a conventional manner and thus do not meaningfully limit the claim.
The detection circuit, estimation circuit and calculation circuit are further well-understood, routine and conventional (WURC) in the art. The applicant states that the system can be implemented by a computer including a non-descript CPU, storage device, interface and a program for control (par. 0085). Said components individually and in combination are WURC as they form the basis for any computerized system.
Claims 9, 10, 12-14, 16 and 18 contain no new additional elements.
Regarding the filtering circuit of claims 11 and 15, said circuit is considered to represent insignificant extra-solution activity. As the applicant states in par. 0085, filtering is not an essential component of the invention and thus not integrated into the abstract idea in any manner other than in a nominal signal processing way. Anti-aliasing and band-pass filters are also WURC in the art of signal processing as a means to limit noise and pass through signals of interest.
Regarding claim 17, the additional element of the non-transitory computer readable storage medium is considered to represent insignificant extra-solution activity as it merely represents a tool upon which the abstract idea is stored, and would be required in any computerized system. The generic storage medium is also WURC in the art. As stated in par. 0085, the storage media can be implemented using a general-purpose computer having standard components.
Regarding new claims 19, 21 and 23, the references to real-time calculations from the sampling data sequence of the electrocardiogram signal of the subject fail to impart eligibility under §101 because the term “real-time” does not impose any limits on the duration of a process itself. Making calculations, for example, in “real-time” does not require that the calculations be performed instantaneously –which no computer can do—or even within a certain time. A human, for instance, can perform calculations in real-time of a duration that may differ from a computer performing the same calculations also in real-time. A cardiologist can, in real-time, review collected data in the form of a visual sampled waveform on a display screen, detect a feature point (e.g., an R peak), search for two sampling points within a predetermined range of the feature point as recited (e.g., look at sample points on either side of the peak that are above or below an isoelectric baseline), estimate a time as recited (judging/extrapolating), calculate an RRI as recited, calculate the product of the adjacent pieces of sampling data (simple math), and compare the product to zero. The processing of signals in real-time only relates to the abstract idea in a nominal way by attempting to invoke generic computer structure in a field of use limitation. Clearly the mere addition of “real-time” to any claim should not render an abstract idea eligible, as §101 analysis must not depend on the claim draftsman’s art (Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984 (warning against a § 101 analysis that turns on "the draftsman’s art")).
Regarding new claims 20, 22 and 24, references to the sampling rate of data collection fail to impart eligibility under §101 because data gathering is considered an insignificant additional element (see discussion above) outside of the mentally performable aspect of the invention. A cardiologist could still review a waveform constructed on a display using a sampling device of the type claimed, and perform the mental steps outlined above. Sampling devices capable of such rates are also WURC in the art as discussed above, and are only nominally related to the abstract idea as a means to gather data in a computerized environment. There are further no restrictions on the overall time of sampling. Even if the cardiologist was instructed to review every single sampling point (as opposed to simply looking for a prominent R-wave and reviewing a limited set of data on either side of the peak), a one or two second interval at, for example, 125 samples/sec would be reasonably performable as such an interval would result in 125 to 250 samples.
Response to Arguments
Applicant's arguments filed October 10, 2025 have been fully considered but they are not persuasive.
The applicant argues that the amendments add specific hardware circuits that are integral to the claimed invention. It is asserted that the use of the term “circuit” denotes physical hardware implementations that perform dedicated signal processing functions in real-time.
This is not convincing because, as stated in MPEP 2106.05(b):
It is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine. Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17, 112 USPQ2d 1750, 1755-56 (Fed. Cir. 2014). See also TLI Communications LLC v. AV Automotive LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (mere recitation of concrete or tangible components is not an inventive concept); Eon Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 623, 114 USPQ2d 1711, 1715 (Fed. Cir. 2015) (noting that Alappat’s rationale that an otherwise ineligible algorithm or software could be made patent-eligible by merely adding a generic computer to the claim was superseded by the Supreme Court’s Bilski and Alice Corp. decisions). If applicant amends a claim to add a generic computer or generic computer components and asserts that the claim recites significantly more because the generic computer is 'specially programmed' (as in Alappat, now considered superseded) or is a 'particular machine' (as in Bilski), the examiner should look at whether the added elements integrate the exception into a practical application or provide significantly more than the judicial exception. Merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 223-24, 110 USPQ2d 1976, 1983-84 (2014). See In re Alappat, 33 F.3d 1526, 1545, 31 USPQ2d 1545, 1558 (Fed. Cir. 1994); In re Bilski, 545 F.3d 943, 88 USPQ2d 1385 (Fed. Cir. 2008)
Therefore, the mere fact that the applicant invokes generic computer circuitry such as an estimation circuit, a calculation circuit, a multiplication circuit, or a comparison circuit to perform the abstract idea is insufficient to convey eligibility because these circuits perform generic computer functions such as searching data, estimating, calculating, multiplying and comparing. They serve merely as the tool upon which the abstract idea is performed. The applicant refers to Fig. 9 as an example of the type of computer configuration that can be used (see “clean copy” specification par. 0086). Figure 9 simply shows a generic block diagram of a computer system including a non-descript CPU, interface device, and storage device, as admitted by the applicant on page 7 of the Remarks.
The applicant has failed to make the case that the multiplication circuit and the comparison circuit are anything other than routine computer circuits functioning in their usual manner to execute an abstract idea in the form of software instructions. The applicant states that this is not a generic mathematical operation performed on arbitrary data, but a specially configured hardware implementation for a particular signal processing task in the ECG measurement field.
In determining eligibility under §101, one must look to the additional elements outside of the abstract idea for the inventive concept. MPEP 2106.05, I. states:
An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016). See also Alice Corp., 573 U.S. at 21-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 78, 101 USPQ2d at 1968 (after determining that a claim is directed to a judicial exception, "we then ask, ‘[w]hat else is there in the claims before us?") (emphasis added)); RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"). Instead, an "inventive concept" is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).
In the instant case, the applicant is relying upon the algorithm (i.e., the mentally performable mathematical calculations using ECG data) and not any additional elements to provide the inventive concept. Again, a generic computer arrangement cannot serve as a basis for eligibility. Reference to ECG data only generally links the use of the judicial exception to the particular technological environment of electrocardiogram signal processing.
The applicant argues that the invention is integrated into a practical application because the sampling rate allows reduced power consumption while maintaining measurement accuracy despite the lower sampling rate by using the multiplication and comparison circuits to identify zero-crossings with sub-sample precision.
This is not convincing because, as stated above, the inventive concept cannot be furnished by the abstract idea itself. The applicant is relying upon the multiplication and comparison circuits –or rather, the functioning thereof—for eligibility. The multiplication and comparison circuits are generic and perform in their usual capacity –to multiply and compare received data in accordance with programming instructions. Any alleged improvement results from execution of the mentally performable abstract idea running on these generic components. Furthermore, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Here the applicant asserts that by using the multiplication and comparison circuitry to perform the abstract idea, one can sample at a lower than usual rate and still retain accuracy. Standard ECG devices, however, typically employ the sampling rates disclosed by the applicant (attention is invited to col. 1, lines 14-26 of the Burton-Krahn et al. ‘654 reference cited herein). Clearly, any asserted advantage lies entirely within the abstract idea as any standard ECG device or human running the algorithm would supposedly gain an accuracy advantage regardless of its sampling rate.
Even if for the sake of argument, one was to agree that there is a practical application, according to MPEP 2106.05(a) the claims must reflect the improvement:
After the examiner has consulted the specification and determined that the disclosed invention improves technology, the claim must be evaluated to ensure the claim itself reflects the disclosed improvement in technology. Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1316, 120 USPQ2d 1353, 1359 (Fed. Cir. 2016) (patent owner argued that the claimed email filtering system improved technology by shrinking the protection gap and mooting the volume problem, but the court disagreed because the claims themselves did not have any limitations that addressed these issues). That is, the claim must include the components or steps of the invention that provide the improvement described in the specification.
Independent claims 8, 12 and 16 contain no limitations directed to the sampling rate. They cannot therefore serve as a basis for eligibility.
The applicant further argues that the claims include significantly more than any judicial exception as they recite specific circuits that do not operate in their usual capacity, but are configured for ECG signal processing and not generic arithmetic operation.
This is not found to be convincing because limitations directed to ECG signal processing merely links the use of the judicial exception to the particular technological environment of electrocardiogram signal processing. Contrary to applicant’s assertions, the multiplication and comparison circuits function in their usual capacity of receiving data (whether it be ECG data, EEG data, EMG data, etc., or any other form of information whether medically related or not) and performing multiplication and comparison operations. The information input does not alter their functioning.
The applicant additionally argues that the examiner has provided no evidence that these “specifically configured circuits for this specific ECG application” are WURC in the art.
The examiner counters that he as indeed provided evidence from the applicant’s own disclosure which states that generic computer components arranged in a conventional configuration (see Fig. 9) can be used to perform the processes described therein (see par. 0085). If the applicant is using unconventional and not well-understood or routine computer components and/or system configurations, then questions regarding the adequacy of disclosure arise under §112(a) because the applicant has provided little detail on supposedly unconventional structure.
The applicant claims that the multiplication and comparison circuits are central to the claimed method of estimating zero-crossing times, but the examiner would argue that the circuits themselves are not essential –just the mentally performable steps associated with these elements. Again, as stated above, the inventive concept must lie within the additional elements beyond the abstract idea. Reciting a multiplication circuit and a comparing circuit for performing a specific function(s) is little different than reciting a generic computer for performing the same multiplication and comparison function(s).
Regarding new claims 19-24, note the comments made above in the rejection of these claims under §101.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The references cited disclose conventional ECG devices incorporating sample rates in the claimed ranges.
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 KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
January 16, 2026