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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 6, 2025 has been entered.
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, 7, 10-13 and 22 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) a mentally performable method (or apparatus as in the case of claims 10, 11 and 22) comprising calculating an amplitude decrease relative value and the absolute value of an amplitude according to the high-frequency QRS waveform data and by means of a first function, so as to form a lead positive index; intercepting exercise-time-period waveform data from the high-frequency QRS waveform data, choosing data at which an RMS voltage value is the largest in the exercise-time-period waveform data as a first reference point, and choosing a point at which the RMS voltage value is the smallest after a time of the first reference point as a second reference point; and calculating a difference between the RMS voltage value of the first reference point and the RMS voltage value of the second reference point by means of the first function to obtain an absolute value of the amplitude, and calculating a ratio of the absolute value of the amplitude to the RMS voltage value of the first reference point to obtain an amplitude decrease relative value, the absolute value of the amplitude and the amplitude decrease relative value constituting a lead positive index; wherein if the absolute value and the amplitude decrease relative value meet a predetermined condition, the lead positive index is indicated as positive; dividing a positive position into a first category or a second category according to a first preset rule; when the high-frequency QRS waveform indicated as positive by the lead positive index is a chest lead, and the high-frequency QRS waveform data output by the chest lead is a plurality of combinations of V1, V2, V3, V4, V5 and V6, dividing the positive position into the first category according to the first preset rule; and when the high-frequency QRS waveform indicated as positive by the lead positive index is a limb lead, and the high-frequency QRS waveform data output by the limb lead is a plurality of combinations of I, II, III, aVL, aVF and aVR, dividing the positive position into the second category according to the first preset rule; calculating a waveform change shape index according to the high-frequency QRS waveform data and by means of a second function, wherein the waveform change shape index is used for indicating a shape category to which a waveform change belongs; and generating an attention level label corresponding to the high-frequency QRS waveform data according to the lead positive index and the waveform change shape index and by means of a second preset rule; acquiring fixed point data that the high-frequency QRS waveform data is located at a peak or a trough, the fixed point data comprising a time value and an RMS voltage value; the fixed point data being coordinates of a fixed point in an electrocardiogram, the fixed point being at a peak or trough position; and inputting the fixed point data into the second function, the second function outputting a waveform change shape index; wherein the waveform change shape index is used for indicating the shape category to which the waveform change belongs, wherein the second function calculates a waveform amplitude according to the amplitude between adjacent fixed points, chooses the largest waveform amplitude calculated according to a single high-frequency QRS waveform data, filters the waveform amplitude smaller than an amplitude threshold calculated according to the largest waveform amplitude, connects the fixed point data corresponding to the retained waveform amplitude according to a time sequence to obtain a shape function, and obtains the waveform change shape index according to the shape function; wherein the waveform change shape index comprises a first shape category, a second shape category and a third shape category; wherein the first shape category comprises at least one of a U-type and an L-type, the second shape category comprises at least one of a W-type, a V- type and an M-type, and the third shape category comprises at least one of a flat-type and an inverted-V-type; generating an attention level label corresponding to the high-frequency QRS waveform data according to the lead positive index and the waveform change shape index, and a divided category of the positive position and by means of a second preset rule; wherein a first attention level to a tenth attention level indicate the different degrees of heart problems by data, used as a reference in a diagnosis process; wherein the first attention level indicates an obstructive coronary lesion and a clinical hospital visit is necessary; wherein a second attention level indicates a coronary microcirculatory disorder and a clinical hospital visit is necessary; wherein third and fourth attention levels indicate an obstructive coronary lesion is likely to occur and further examination and determination are required; wherein fifth and sixth attention levels indicate anon-obstructive coronary lesion is likely to occur and further examination and determination are required; wherein seventh and eighth attention levels require further examination; wherein ninth and tenth attention levels may classify into a sub-health management status, only periodic retests are required.
The above steps can be performed within the mind or with the aid of pen and paper as the steps involve the mentally performable processes of observation, evaluation, judgement and opinion. It should further be noted that the step of acquiring fixed point data (claims 1 and 22) is considered a mental step as it involves observation of the QRS waveform to locate peaks or troughs and the calculation of RMS voltages –evaluation/analysis. Even if such a step were to be considered an additional element, such a step would amount to insignificant data gathering in the same manner describe below in association with the step of acquiring high-frequency ORS waveform data.
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), because the computer device comprising a memory and a processor (see claims 10 and 11), or the various calculation/labeling modules of claim 22, functions 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 analysis and display of QRS complex data – 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 processor and memory 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 display; 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 a particular technological environment of QRS complex analysis, 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 step of acquiring high-frequency QRS waveform data, which is output by means of at least one electrocardiogram lead, represents insignificant extra-solution data gathering activity that would be required in any system attempting to process high frequency QRS complex data. A parallel comment applies to claims 3 and 12 where the high frequency data is further defined as being in an interval of 150 Hz to 250 Hz and acquired by an electrode pad applied to a human body. Such data gathering is only nominally related to the invention and would be required in order to ensure collection of high frequency QRS complex data necessary for the performance of the abstract idea. The collection of cardiac data by electrode pads applied to the human body is well-known.
Claims 7 and 13 contain no new additional elements.
Regarding claim 10’s recitation of a computer device comprising a memory and a processor, such additional elements are generic, function in their usual capacity, and are thus insignificant to the invention as they merely function as a tool upon which the abstract idea is performed. Similar comments apply to claim 11.
Regarding apparatus claim 22, comments similar to those made above regarding the inclusion of a data acquisition module apply here as well. The various calculating and labeling modules recited are insignificant as they merely function as the object upon which the abstract idea is performed. Collectively, the arrangement of modules act as a general purpose computer performing conventional calculation and labeling functions in accordance with the programming required by the judicial exception. As stated in MPEP 2106.05(b), the mere addition of a specially programmed generic computer or generic computer components, is insufficient to integrate the exception into a practical application. The printing of the high-frequency QRS waveform and the attention level to generate a test result is considered insignificant data outputting that would be required in any practice of the judicial exception in order to provide the results of the calculations in human perceivable form to a cardiologist or other physician for review.
The use of an electrocardiogram lead or electrode pad to gather the desired cardiac data is also WURC in the art, as the standard manners of obtaining patient data. Further, the use of a computer device comprising generic memory and a generic processor, or generic modules associated with the processor, is also WURC in the art as such elements and their combination form the basic building blocks of any computerized system. As disclosed by the applicant on page 20 of the present specification, those skilled in the art will appreciate that the structure shown in FIG. 8 is merely a block diagram of a portion of the structure relevant to the present application, and does not constitute a limitation on the computer device to which the present application is applied, and a particular computer device may include more or fewer components than shown in the figure, or combine some components, or have a different arrangement of components. A variety of different well-known memory types is also disclosed as suitable to the practice of the present invention as well (see also page 20).
Response to Arguments
Applicant's arguments filed June 6, 2025 have been fully considered but they are not persuasive.
The applicant’s amendment has overcome the §103 rejections contained within the previous Office Action.
Regarding the rejection under §101, the applicant argues that claims 1, 3, 7, 10-13 and 22 involve mathematical concepts and calculations which fall into the mental processes grouping, but for the lead positive index recitation.
The examiner considers the lead positive index recitation (see claim 1) to be an index that can be created within the mind or with the aid of pen and paper, as it simply requires one to calculate an absolute value, observe an amplitude decrease relative value in the data, and assign a positive index value if the absolute value and the amplitude decrease relative value meet a predetermined condition.
The applicant further argues that the waveform shape change index recites a specific technical process for obtaining a shape function, wherein each waveform shape change corresponds to a different shape category. The process is stated to involve selecting adjacent fixed points, connecting those points to derive a shape function, and matching the resulting shape against a preset value. The process is asserted to require various determinations that involve quantitative analysis and signal processing that cannot be practically performed in the human mind.
This argument is not found to be convincing because it is not adequately explained why a human cannot follow the specific technical process by selecting adjacent fixed points, connecting those points, and matching the resulting shape against a preset value. Such a procedure merely involves observation, evaluation and judgement. The human mind is exceptional at pattern/shape matching (e.g., facial recognition). Children, for example, have long played the game “connect the dots” where adjacent fixed points are connected by drawing lines therebetween to form recognizable shapes/patterns/images.
Regarding the printing step, the applicant argues that such a step involves the generation of a tangible output and is not a process that can be practically performed within the human mind as it requires a physical printing mechanism.
The examiner agrees that the recited printing step is an additional element outside of the abstract idea, but considers the act of printing to constitute insignificant data outputting as discussed in the rejection above. All practices of the judicial exception would require some form of human perceivable output to notify one of the results. The fact that it requires a physical printing mechanism is immaterial to the question of eligibility. As stated in MPEP 2106.05(b), the mere recitation of concrete or tangible components operating in a conventional manner is not an inventive concept (TLI Communications LLC v. AV Automotive LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016)).
The applicant does not consider the claims to recite mathematical concepts per se in accordance with MPEP 2106.04(a)(2) subsection I.
The examiner, however, considers the claims to recite mental processes in accordance with MPEP 2106.04(a)(2) subsection III.
Under Step 2A, Prong Two, the applicant argues that while claim 1, 3, 7, 10-13 and 22 recite a mental process (page 12, par. 3 of the Remarks), the judicial exception is integrated into a practical application by specifically indicating different degrees of heart problems, which presumably improve the technology and technical field related to the diagnosis of heart problems by reducing the subjectivity and time required for doctors to infer disease labels. It is further stated that the invention facilitates application to different treatments.
This is not considered to be convincing because the inventive concept must be furnished by an element or combination of recited elements that is in addition to or beyond the judicial exception (MPEP 2106.05 I.). Here the applicant is instead relying on the judicial exception itself (i.e., the steps identified as mentally performable) to provide any claimed technological improvement. The recited additional elements in the present application (e.g., the step of acquiring high-frequency QRS waveform data from an ECG lead; the processor/modules; the memory or storage media; and the step of printing) function in their usual capacity of collecting data, processing data, storing data, and printing data, much like any conventional general-purpose computer or ECG monitoring device. Claiming improved speed or efficiency inherent with applying the abstract idea on a computer does not integrate the judicial exception into a practical application or provide an inventive concept (MPEP 2106.05(f)(2)). Furthermore, merely facilitating application to different treatments is insufficient because in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition (MPEP 2106.04(d)(2)).
The applicant’s reference to other patents or pre-grant publications in an effort to show claim similarity in the context of §101 is ineffective because each case must stand on its own merits. Furthermore, the ‘340 patent and the patent based on the ‘292 publication were granted well before the 2019 Revised Patent Subject Matter Eligibility Guidelines.
It is further implied that the present claims address particular cardiac ailments and therefore relate to a particular treatment (Remarks, page 13). This is not convincing because the claims fail to effect any particular treatment or prophylaxis as discussed above. The indication of various degrees of heart problems is purely diagnostic.
Regarding application of Step 2B, the applicant argues that claim 1 as a whole is directed to improvements to the technology and technical field of electrocardiography, through the use of a non-invasive processing method by using a lead positive index, positive position and analysis of high-frequency QRS waveform data to generate an attention level label, indicating different degrees of heart problems, thus enhancing diagnostic objectivity and reducing the time for reading ECGs.
The examiner once again responds that the inventive concept must be furnished by an element of the invention outside or beyond the abstract idea (the abstract idea including, among other features, the determination of a lead positive index, positive position and analysis of high-frequency QRS waveform data to generate an attention level label indicating different degrees of heart problems). All uses of the judicial exception require high-frequency data gathering, and therefore the additional element fails to integrate the judicial exception into a practical application. The means used to collect the high-frequency data is further WURC in the art. The applicant discloses that the high-frequency QRS waveform is outputted by means of at least one electrocardiogram chest lead and/or limb lead, and includes standard 12-lead configurations or other known configurations according to need (page 8, lines 19-26). The mere collection of data necessary to perform the abstract idea thus fails to integrate the additional element into a practical application. The printing of the diagnostic result is similarly insignificant as already discussed above. The applicant’s well-understood, routine and conventional elements (e.g., the ECG lead for data collection, the processor/modules, the memory, and printer) function in their usual capacity and are not improved in any way by the execution of the abstract idea. They merely function individually, and in combination, as the tool upon which the abstract idea is contained and run. Considering the claim as a whole, any asserted improvement lies within the abstract idea’s decision to process and manipulate these signals and not in the collection of said signals.
Lacking any integration into a practical application, the rejection under §101 must stand.
The applicant’s extensive amendment was considered sufficient to distinguish over the prior art of record. The rejection under §103 has thus been removed.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 on the 2nd Monday of the biweek and W-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E. Hamaoui can be reached on 571 270 5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
September 19, 2025
Prosecution Insights