Ex Parte Healey et alDownload PDFPatent Trial and Appeal BoardJan 10, 201311146745 (P.T.A.B. Jan. 10, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte JENNIFER HEALEY and BETH T. LOGAN __________ Appeal 2011-000368 Application 11/146,745 Technology Center 3700 __________ Before DEMETRA J. MILLS, MELANIE L. McCOLLUM, and JACQUELINE WRIGHT BONILLA, Administrative Patent Judges. BONILLA, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims directed to computer implemented methods, apparatus, and programs for detecting atrial fibrillation in an electrocardiogram (ECG) signal. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2011-000368 Application 11/146,745 2 STATEMENT OF THE CASE The Specification describes a computer implemented method for automatically detecting atrial fibrillation in an ECG signal (Spec. 4). An ECG typically has “a regular sequence of deflections (waves), labeled P, QRS, T and U,” as shown in Figure 2 of the Specification (id. at 2). After computing intervals between successive R peaks in QRS complexes (i.e., R- R intervals), the method computes a variance of normalized intervals over a sliding window in the ECG signal and compares that variance with a threshold to provide an indication of whether atrial fibrillation is present in the window (id. at 4-5). “An indication of whether atrial fibrillation is present in a beat window in the ECG signal may be provided dependent on a number of windows within the beat window in which atrial fibrillation has been detected” (id. at 5). “In one embodiment, the window is 10 seconds, the beat window is 600 beats and the settable threshold is 200” (id.) Claims 1-4, 6-11, and 13-20 are on appeal. Independent claims 1 and 11 are representative and read as follows: (emphasis added): 1. A computer implemented method for automatically detecting atrial fibrillation in an ECG signal comprising: detecting QRS complexes in the ECG signal including computing R-R intervals, wherein detecting QRS complexes is morphology independent; based on the computed R-R intervals in the detected QRS complexes, normalizing the R-R intervals and computing a R-R interval variance of the normalized intervals over a sliding window in the ECG signal; and comparing the computed R-R interval variance with a threshold to provide an indication of whether atrial fibrillation is present in the window. Appeal 2011-000368 Application 11/146,745 3 11. A computer apparatus for automatically detecting atrial fibrillation in an ECG signal comprising: a QRS detector stored in a memory which detects QRS complexes in the ECG signal and computes R-R intervals; and a normalize routine which normalizes the computed R-R intervals and computes a R-R interval variance of the normalized intervals over a sliding window in the ECG signal, the normalize routine comparing computed R-R interval variance with a threshold to provide an indication of whether atrial fibrillation is present in the window; wherein the sliding window is less than or equal to 10 seconds. Other independent claims similarly recite “detecting QRS complexes in the ECG signal including computing R-R intervals, wherein detecting QRS complexes is morphology independent,” and/or “computing a variance of normalized intervals over a sliding window in the ECG signal.” All claims on appeal stand rejected under 35 U.S.C. § 103(a) as obvious over Lohman, 1 including by reference Adams, 2 in view of Zong, 3 and in further view of Greenhut. 4 Analysis The Examiner states that “Lohman discloses the claimed invention except for a morphologically independent QRS detector (claims 1, 4, 6, 7, 8, 11 and 13-20)” (Ans. 5). The Examiner finds that “Zong teaches QRS 1 Lohman et al., US 7,117,031 B2, issued Oct. 3, 2006. 2 Adams et al., US 5,350, 404, issued Sept. 27, 1994. 3 Zong et al., A Robust Open-source Algorithm to Detect Onset and Duration of QRS Complexes, 30 COMPUTERS IN CARDIOLOGY 737-740 (2003). 4 Greenhut et al., US 5,480,413, issued Jan. 2, 1996. Appeal 2011-000368 Application 11/146,745 4 complexes analysis using a robust open-source algorithm that is insensitive to QRS morphology change for the purpose of detecting the onset and duration of the QRS complexes” (id.). According to the Examiner, it would have been obvious to an ordinary artisan to use the open-source algorithm disclosed in Zong in the Lohman system (id.). We agree with Appellants, and the Examiner concedes, that “Zong discloses an algorithm that eliminates R peaks” (App. Br. 22; Ans. 8 (stating that the “examiner also agrees that Zong et al. disclose an algorithm that eliminated R-peaks”); Suppl. Ans. 3). As explained by Appellants, in Zong “a QRS complex visible in the ECG signal (ECG), with Q, R, and S waves labeled, is modified to a QS segment of an LT wave in the length transform (LT) signal” (id. at 23). Thus, Zong‟s algorithm does not involve computing or the use of R-R intervals. The Examiner states that “use of the Zong et al. algorithm to determine the cycle length and replace the less accurate system based on the R-R interval is the precise intent of the combination” of Lohman and Zong, so “that the Lohman et al. system is enhanced with a more precise indication of the QRS complex and in turn the cardiac cycle length” (Ans. 8). Appellants persuade us, however, that “in order to achieve morphological independent when detecting QRS complexes, . . . Zong expressly teaches the elimination of R peaks and consequently any measurement of R-R intervals” (1 st Reply Br. 6). Thus, the cited references do not “teach or suggest the claimed method that achieves both the computing of R-R intervals and, at the same time, morphological independence” (2 nd Reply Br. 9). In other words, even assuming one would Appeal 2011-000368 Application 11/146,745 5 have had reason to use the algorithm of Zong for the reasons stated by the Examiner, a method, apparatus or program code using that algorithm would not have involved “computing R-R intervals,” as required by independent claims 1, 4, 6-8, and 14-16 (and therefore dependent claims 2, 3, 9, and 10). We note that independent claims 11, 13, and 17-20 do not recite “morphology independent” as recited in other claims. Appellants further argue, however, that the cited references do not teach or suggest “a normalize routine which normalizes the computed R-R intervals and computes a R-R interval variance of the normalized [R-R] intervals,” as recited in claims 11 and 13 (App. Br. 29, 24-25), or “computing a variance of normalized intervals,” as recited in claims 17-20 (id. at 30-31, 24-25). In other words, Appellants argue that the cited reference do not teach or suggest the use of normalized R-R intervals, as required in claims 11, 13, and 17-20. The Examiner finds Lohman discloses “a step to sub-band segments of RR-interval, and normalize the data which serves as a smoothing routine for the sub-banded segments (step 214)” (Ans. 4 (citing Lohman, col. 10, ll. 13-19)). The Examiner also states, however, that “modified Lohman [in view of Zong] discloses the claimed invention except for normalizing the R- R intervals (claims 1, 4, 6, 7, 8, 11 and 13-20)” (id. at 5). Thus, the Examiner relies on Greenhut for disclosing normalized R-R intervals (id. at 6; Suppl. Ans. 4). Greenhut discloses a pacemaker that detects and corrects for ventricular rate instability that occurs during atrial fibrillation (Greenhut, Appeal 2011-000368 Application 11/146,745 6 abstract, col. 2, ll. 18-22). As cited in relevant part by the Examiner (Ans. 6), Greenhut states: Ventricular rate stability can be found using a number of different methods. For example the interval between two R waves (standard in the pacemaker field) can be measured and the stability of this parameter may be defined in terms of statistical variance, standard deviation, rate mean squared difference, normalized mean absolute deviation, normalized approximate interquartile range, autocorrelation, Markov chains, coefficient of variation, histograms, using maximum, average, and minimum values stored in a look-up table, or a normalized mean absolute difference, . . . . (Id. at col. 5, ll. 11-20 (emphasis added).) Appellants argue that “Greenhut involves only three normalized measures, namely, „normalized mean absolute deviation,‟ „normalized approximate interquartile range,‟ and „normalized mean absolute difference‟” (App. Br. 25). Thus, according to Appellants, Greenhut “does not disclose or suggest normalizing the R-R intervals themselves, but instead involves normalizing a deviation, a range, or a difference” (id.). In response, the Examiner states: “While it is true Greenhut teaches normalizing in terms of a deviation, a range and a difference, the data normalized is the R-R interval data” (Ans. 9; see also Suppl. Ans. 4). Greenhut teaches, however, that normalized deviation, interquartile range and/or mean absolute difference may provide information about stability of the R-R interval (Greenhut, col. 5, ll. 11-20). Such normalized deviation, range and/or difference are not the same thing as normalized R-R intervals themselves, as the claims require. As indicated in the Specification, the R-R interval is normalized using the equation “RRnorm = RR/RRmean * 100” (Spec. Appeal 2011-000368 Application 11/146,745 7 11). The Examiner does not adequately explain how normalizing deviation, interquartile range and/or mean absolute difference render obvious normalizing R-R intervals or the use of normalized R-R intervals. Thus, Appellants persuade us that “while the deviation, range and difference normalized are related to the R-R interval, they are not, themselves, the R-R interval” (1 st Reply Br. 7). We agree that the Examiner has failed to establish that Greenhut “teaches normalizing the R-R intervals themselves as opposed to normalizing other statistics about the R-R interval as taught by Greenhut” (id. at 8). SUMMARY For the reasons discussed above, we reverse the rejection of claims 1- 4, 6-11, and 13-20 as obvious over Lohman, including by reference Adams, in view of Zong, and in further view of Greenhut. REVERSED cdc Copy with citationCopy as parenthetical citation