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 .
Specification
The disclosure is objected to because of the following informalities: the status of the ‘357 application listed on page 1 must be updated; the reference to related application 16/646,393 is clearly in error as the title of the ‘393 application does not relate to classifying ECG signals. It appears that the applicant is attempting to refer to application no. 15/646,393.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6-13 and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,071,489. Although the claims at issue are not identical, they are not patentably distinct from each other because the present invention’s claims are merely broader in scope than the patented claims. Once the applicant has received a patent for a species or a more specific embodiment, he is not entitled to a patent for the generic or broader invention (see In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993)).
All features of claim 1 map directly to patented claim 1 (or equivalent patented apparatus claim 11), with the claimed step of eliminating annotations based on a subset of extracted features mapping to the narrower patented step involving the elimination of annotations that have a confidence level below a threshold, and the claimed step of eliminating annotations based on a pair reduction analysis, mapping to the narrower patented step of merging two annotations that arise from a single occurrence as a single annotation. Like comments apply to apparatus claim 10 and method claim 19.
Claims 5 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,071,489 in view of Houben et al. (Pub. No. 2015/0208938).
Regarding claims 5 and 14, while the ‘489 invention does not reference the use of normalized zero mean Gaussian functions for decreasing noise in the unipolar and bipolar derivative signals, Houben discloses a substantially similar system wherein it is taught that derivative functions of ECG complexes enhance high frequency noise (par. 0084). In order to filter the noise, normalized zero mean Gaussian functions are used. Given the known issue of high frequency noise enhancement associated with the derivative of an ECG signal and the common goal in the art to reduce noise, those of ordinary skill would have considered the application of such filters to derivatives of either bipolar and/or unipolar derivative signals to be a matter of obvious signal processing.
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 1-20 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) an abstract idea comprising the mentally performable steps of computing a local unipolar minimum derivative of the unipolar ECG signal at a plurality of times of occurrences of the local unipolar minimum derivative; computing a bipolar derivative of the bipolar ECG signal; evaluating a ratio of the bipolar derivative to the local unipolar minimum derivative at the plurality of times of occurrences of the local unipolar minimum derivative; annotating each time of occurrence as a time of activation of the myocardium at the location in the heart when the ratio is greater than a threshold value; extracting features of the annotations and assigning a confidence level to each feature; eliminating annotations based on a subset of the extracted features resulting in a first plurality of candidate annotations; eliminating annotations from the first plurality of candidate annotations based on a pair reduction analysis, resulting in a second plurality of candidate annotations. Said steps involve observation, evaluation, judgement and opinion.
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 probe with a pair of electrodes, the processor and the implied display operate in their usual capacity to collect, analyze and display data; there is no application or use of a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition – 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 an arrangement of generic components in a conventional manner; 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 ECG 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 steps of receiving a bipolar ECG signal from a location in a heart from a pair of electrodes, where the bipolar ECG signal comprises two unipolar ECG signals and receiving one of the unipolar signals (claims 1, 10 and 19), represents necessary data gathering as it would be required in order to provide the input data to execute the abstract idea. Furthermore, the step of generating a local activation time map using the second plurality of candidate annotations, represents necessary data outputting. Such an additional element is required in order to convey the results of the performance of the abstract idea in human readable form.
Similar comments apply to apparatus claim 10, wherein in addition to the above elements, the probe with a pair of electrodes and the generic processor function as necessary additional elements to gather and process data. They would be required in any ECG signal processing system attempting to execute the abstract idea.
The collection of ECG data using a probe with at least two electrodes to obtain bipolar ECG signals (the bipolar ECG signal inherently comprising two unipolar ECG signals –one for either electrode) is also WURC in the cardiac monitoring art. The applicant further discloses that any type of probe may be used, including those already made commercially available (page 21, pars. 3 and 4). The generation of local activation maps is also WURC in the cardiac monitoring art as discussed by the applicant in the Background of the Invention section. The use of a generic processor is also WURC in any computerized medical system as it is the tool upon which every computer algorithm is run. The combination of an electrode probe to collect ECG data, a processor to analyze and process the data, and an output to display the processed data is also WURC as these elements represent the basic building block of most any cardiac mapping and imaging system.
Regarding claims 2-5 and 10-14, the use of pre-processing to remove signal noise is considered only nominally related to the abstract idea and fails to integrate the abstract idea into a practical application. Such processing using various filters and Gaussian filter functions is WURC in the signal processing art and functions to provide a usable signal free from artifacts and noise (e.g., low frequency baseline wander, high frequency noise, etc.), upon which further analysis may be accurately based.
Claims 6-9, 15-18 and 20 contain no new additional elements outside of the mentally performable abstract idea.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gaeta ‘258 discloses the determination of LATs using bipolar electrodes and the subtraction of unipolar signals from one another to reject far field signals.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E. Hamaoui can be reached at 571 270 5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
April 2, 2026
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