Ex Parte Fendelander et al

Patent Trial and Appeal BoardApr 27, 2016

12630735 (P.T.A.B. Apr. 27, 2016)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 12/630,735 12/03/2009 Lahn Fendelander 06541-0034001 1313 7590 04/27/2016 Cambridge Heart, Inc. 46 Jonspin Road Wilmington, MA 01887 EXAMINER LEVICKY, WILLIAM J ART UNIT PAPER NUMBER 3762 MAIL DATE DELIVERY MODE 04/27/2016 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte LAHN FENDELANDER, ALI HAGHIGHI-MOOD, and RICHARD J. COHEN ____________ Appeal 2014-002550 Application 12/630,7351 Technology Center 3700 ____________ Before JOHN C. KERINS, STEFAN STAICOVICI, and LEE L. STEPINA, Administrative Patent Judges. STAICOVICI, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Lahn Fendelander et al. (Appellants) seek our review under 35 U.S.C. § 134 of the Examiner’s final decision rejecting claims 1, 3–22, 24–33, and 35–482. We have jurisdiction under 35 U.S.C. § 6(b). SUMMARY OF DECISION We AFFIRM. 1 According to Appellants, the real party in interest is Cambridge Heart, Inc. Appeal Br. 1 (filed Sept. 3, 2013). 2 Claims 2, 23, and 34 have been canceled. Appeal Br. Claims App’x. Appeal 2014-002550 Application 12/630,735 2 INVENTION Appellants’ invention is “directed to the measurement of alternans in conjunction with testing for coronary artery disease and cardiac ischemia.” Spec. 1, ll. 7–8. Claims 1, 22, 33, and 40 are independent. Claims 1 and 40 are illustrative of the claimed invention and read as follows: 1. A method for detecting cardiac ischemia, the method comprising: receiving one or more electrocardiographic signals from a subject, a portion of the electrocardiographic signals comprising an electrocardiogram waveform; detecting, using at least one processor, the occurrence of alternans in the electrocardiographic signals; determining one or more characteristics of detected alternans, the characteristics including a location of detected alternans within the electrocardiogram waveform; and analyzing the determined characteristics of the detected alternans to determine whether cardiac ischemia is present, the analyzing including analyzing the determined location of the detected alternans to determine whether the cardiac ischemia is present. 40. A method for detecting cardiac ischemia, the method comprising: receiving first cardiac signal data generated from measured heart beats of a subject from one or more electrodes on the skin of the subject; determining, using an electronic processor, characteristics of alternans occurring in the first cardiac signal data; receiving second cardiac signal data generated from measured heart beats of the subject from the one or more electrodes on the skin the subject after the subject has undergone a change relating to cardiac stress; determining characteristics of alternans occurring in the second cardiac signal data; Appeal 2014-002550 Application 12/630,735 3 analyzing a difference between the characteristics of alternans occurring in the first cardiac signal data and the characteristics of alternans occurring in the second cardiac signal data; and providing an indication related to cardiac ischemia based on the analyzed difference between the characteristics of alternans. THE REJECTIONS The following rejections are before us for review: I. The Examiner rejected claims 1, 3–12, 15–22, 24–26, 29–33, 35–43, and 45–48 under 35 U.S.C. § 103(a) as being unpatentable over Zhou (US 2006/0116596 A1, pub. June 1, 2006) and Chow (US 2009/0048529 A1, pub. Feb. 19, 2009). II. The Examiner rejected claims 13 and 14 under 35 U.S.C. § 103(a) as being unpatentable over Zhou, Chow, and Rowlandson (US 2005/0234355 A1, pub. Oct. 20, 2005). III. The Examiner rejected claims 27, 28, and 44 under 35 U.S.C. § 103(a) as being unpatentable over Zhou, Chow, and Brockway (US 2007/0244402 A1, pub. Oct. 18, 2007). ANALYSIS Rejection I Claims 1, 3–12, 15–22, 24–26, 29–33, and 35–39 Appellants have not presented arguments for the patentability of claims 3–12, 15–22, 24–26, 29–33, and 35–39 apart from claim 1. Appeal Br. 3–6. Therefore, in accordance with 37 C.F.R. § 41.37(c)(1)(iv), we select claim 1 as the representative claim to decide the appeal of the Appeal 2014-002550 Application 12/630,735 4 rejection of these claims, with claims 3–12, 15–22, 24–26, 29–33, and 35–39 standing or falling with claim 1. The Examiner finds that Zhou discloses a method/system for detecting a cardiac condition including, inter alia, receiving one or more electrocardiographic signals from the patient, detecting the presence of alternans in the electrocardiographic signals, and “determining one or more characteristics of detected alternans.” Final Act. 4 (citing Zhou, ¶¶ 14, 15, and 25). The Examiner relies on Chow for disclosing monitoring detected alternans for changes, i.e., “determines a location,” and using “alternans measurements . . . to facilitate the diagnosis of ischemia . . . [and] to provide better patient care by alerting patients/physicians to cardiac anomalies.” Id. at 4–5 (citing Chow, ¶¶ 28 and 35). The Examiner thus concludes that “[i]t would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system/method as taught by Zhou,” according to Chow, because, “such a modification would provide the predictable results of providing better patient care by alerting patients/physicians to cardiac anomalies and providing faster diagnosis of possible cardiac conditions.” Id. at 5. Appellants assert that because “Chow looks for the presence of T- wave alternans by looking at the T-wave portions of the EGM signals,” “[d]etecting change in the level of T-wave alternans is in no way synonymous with determining a location of detected alternans within an electrocardiogram waveform.” Appeal Br. 4–5. Appellants argue that “Chow looks at the level of T-wave alternans at different heart rates, and, like Zhou, Chow does not determine the location of alternans within an electrocardiogram waveform, or use such a determined location to determine Appeal 2014-002550 Application 12/630,735 5 whether cardiac ischemia is present.” Id. at 5. Appellants assert that “the fact that Chow is determining TWA (i.e., T-wave alternans), necessarily means that Chow is assessing the T-wave portion.” Reply Br. 2. We are not persuaded by Appellants’ arguments because, as the Examiner correctly notes, Zhou looks at various locations of alternans within an electrocardiogram waveform, namely, T-wave and R-wave segments (see Ans. 2 (citing Zhou, ¶ 41); see also Zhou, ¶¶ 53 and 76 for QRS alternans). Similarly, Chow also looks at various locations of alternans within an electrocardiogram waveform, that is, alternans that are located within the T- wave segment or the ST segment of the recorded ECG data. See Ans. 3; see also Chow, ¶ 28. The Examiner relies on Chow because Zhou broadly teaches using alternans as a factor in predicting cardiac events (see Zhou, ¶ 15), whereas Chow specifically teaches that the presence of alternans in either the T-wave segment (T-wave alternans or TWA) or the ST segment locations is a factor in determining whether ischemia is present and thus facilitates the diagnosis of cardiac ischemia (see Chow, ¶¶ 4, 35). Although we appreciate Appellants’ position that Chow detects changes in alternans “at the T-wave portions of the EGM signals” (see Appeal Br. 4), we note that Chow’s method is not limited to just this. “[A] prior art reference is relevant for all that it teaches to those of ordinary skill in the art.” In re Fritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992). Chow chooses to focus on TWA location, because “changes in ischemic burden may cause changes in TWA, which in some cases may be more sensitive than conventional ST segment monitoring.” Chow, ¶ 35 (emphasis added). In other words, although Chow preferably analyzes the alternans detected in the T-wave segment location, this is because such a location is more sensitive than the Appeal 2014-002550 Application 12/630,735 6 ST segment location for diagnosing ischemia in some cases, and is not, contrary to Appellants’ contention, because it is the only location that Chow analyzes alternans for indicating cardiac ischemia. Accordingly, in Chow the location of alternans in either the T-wave segment (T-wave alternans or TWA) or the ST segment is a factor in determining whether ischemia is present and thus can be used to facilitate diagnosing cardiac ischemia. Therefore, as Chow determines a location of alternans in discerning that such alternans are within the T-wave segment, as opposed to another location, Chow discloses determining a location of alternans within an electrocardiogram waveform, as called for by claim 1. See Chow, ¶ 35. Furthermore, because Chow uses the data associated with the T-wave alternans, in addition to heart rate, for analyzing whether cardiac ischemia is present Chow discloses analyzing the location of alternans to determine whether ischemia is present. See Ans. 3 (citing Chow, ¶ 12). Appellants also argue that “the rejection does not include a well- reasoned rationale for combining the teaching[s] of Zhou and Chow,” and rather, the Examiner has “relied upon an impermissible hindsight reconstruction of the invention.” Appeal Br. 5–6. We are not persuaded by Appellants’ argument, because the Examiner has provided a reasoning with rational underpinnings, namely, “to provide better patient care by alerting patients/physicians to cardiac anomalies and providing faster diagnosis of possible cardiac conditions.” Final Act. 5; see also In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds [require] some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”) (cited with approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). The Appeal 2014-002550 Application 12/630,735 7 Examiner’s reasoning is based on Chow’s capability to alert patients/physicians to cardiac anomalies and provide faster diagnosis of possible cardiac conditions. See id. at 4–5 (citing Chow, ¶ 28). As such, we are not persuaded that the Examiner’s determination of obviousness is based on impermissible hindsight reconstruction. In conclusion, for the foregoing reasons, we sustain the rejection under 35 U.S.C. § 103(a) of claim 1, and claims 3–12, 15–22, 24–26, 29–33, and 35–39 falling with claim 1, as unpatentable over the combined teachings of Zhou and Chow. Claims 40–43 and 45–48 Appellants have not presented arguments for the patentability of claims 41–43 and 45–48 apart from claim 40. Appeal Br. 7. Therefore, we select claim 40 as the representative claim to decide the appeal of the rejection of these claims, with claims 41–43 and 45–48 standing or falling with claim 40. The Examiner finds that Zhou discloses most of the limitations of claim 40, including “providing an indication related to cardiac events based on the analyzed difference between the characteristics of alternans.” Final Act. 11 (citing Zhou, ¶ 67). The Examiner relies on Chow as teaching that “it is known to use changes in alternans to facilitate the diagnosis of ischemia as set forth in Paragraph [0035] and to use internal or external ECG electrodes to receive cardiac signals as set forth in Paragraph [0028] to provide . . . faster and more dynamic diagnosis of cardiac conditions.” Id. at 11–12. The Examiner concludes that “[i]t would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Appeal 2014-002550 Application 12/630,735 8 the method as taught by Zhou,” by “providing an indication related to cardiac ischemia based on the changes in alternans with one or more electrode on the skin as taught by Chow,” because “such a modification would provide the predictable results of providing faster and more dynamic diagnosis of cardiac conditions.” Id. Appellants assert that Chow does not suggest “detecting characteristics of alternans occurring in cardiac signal data generated using electrodes on the skin of a subject, or analyzing the detected characteristics in the manner recited in claim 40.” Appeal Br. 6–7. Appellants argue that “although Chow appears to disclose that external ECG electrode techniques may be used, Chow uses the external ECG electrode techniques to reprogram the safe heart rate (see Chow at ¶ 0028), not to determine characteristics of alternans.” Id. at 7. Appellants’ arguments are not persuasive, because Chow “reprograms the safe heart rate zone only when the surface ECG electrode test confirms that the patient has significant T wave alternans within the current safe heart rate zone.” Chow, ¶ 10. Thus, as the Examiner correctly notes “diagnosis of the (heart rate) HR threshold for TWA or ischemia still requires external testing using [external] ECG electrodes.” Ans. 5 (citing Chow, ¶ 28). Because the characteristics of the alternans are determined using an implantable device (see Chow at ¶¶ 11, 12 and 31) such retesting (confirmation) using an external electrode would also determine the characteristics of the alternans. Moreover, Appellants’ arguments are not commensurate with the Examiner’s rejection, because the Examiner does not solely rely on Chow for analyzing the location of alternans. Specifically, the Examiner finds that Zhou teaches “providing an indication related to cardiac Appeal 2014-002550 Application 12/630,735 9 events based on the analyzed difference between the characteristics of alternans,” and that Chow teaches that ischemia constitutes a cardiac event. See Final Act. 11–12 (citing Zhou, ¶ 67 and Chow, ¶¶ 28 and 35). Because Appellants provide no persuasive evidence or technical explanation as to why the combined teachings of the references as proposed by the Examiner do not meet the claims, we are not apprised of Examiner error. Appellants also argue that “Zhou is specifically directed towards an implanted device,” and that “Zhou distinguishes his technique from techniques that rely on ‘surface ECG recordings.’” Appeal Br. 7 (citing Zhou, ¶¶ 3, 14; Abstract). Based on this, Appellants argue that “one of ordinary skill would not have been led to modify Zhou to include at least one sensor that attached to a subject’s skin because doing so would result in Zhou’s system no longer being an implanted medical device.” Id. We do not find Appellants’ arguments persuasive because as the Examiner correctly finds, “Zhou sets forth that TWA is observable on surface electrocardiogram (ECG) recordings and has been assessed in the past using surface ECG recordings.” Ans. 4 (citing Zhou, ¶¶ 2 and 3). As the Examiner correctly explains, Zhou’s disclosure of a less efficient alternative does not constitute a teaching away from this alternative, as such disclosure does not “criticize, discredit, or otherwise discourage” the Examiner’s modification. See id. at 4–5 (citing In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)). “A known or obvious [product] does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554 (Fed. Cir. 1994). “The fact that the motivating benefit comes at the expense of another benefit … should not nullify its use as a basis to modify the Appeal 2014-002550 Application 12/630,735 10 disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another.” Winner Int'l Royalty Corp. v. Wang, 202 F.3d at 1349 n.8 (Fed. Cir. 2000). Moreover, given that Chow also discloses both internal and external sensors (see Chow, ¶ 28), the Examiner has a solid basis for concluding that “it would have been obvious to use surface electrode recordings which [are] used to observe TWA and to use these observations to provide indication of cardiac ischemia.” Ans. 5. Hence, the Examiner is on solid ground in using the external electrodes of Chow as an alternative to the internal electrodes of Zhou in order to “provide the predictable results of providing faster and more dynamic diagnosis of cardiac conditions.” See Final Act. 12. In conclusion, for the foregoing reasons, we sustain the rejection under 35 U.S.C. § 103(a) of claim 40 as unpatentable over Zhou and Chow. Claims 41–43 and 45–48 fall with claim 40. Rejections II and III Appellants do not set forth any separate substantive arguments with respect to Rejections II and III. See Appeal Br. 7; Reply Br. 3. We thus, sustain the rejections under 35 U.S.C. § 103(a) of claims 13 and 14 as unpatentable over Zhou, Chow, and Rowlandson; and of claims 27, 28, and 44 as unpatentable over Zhou, Chow, and Brockway. SUMMARY We affirm the Examiner’s decision to reject claims 1, 3–22, 24–33, and 35–48. Appeal 2014-002550 Application 12/630,735 11 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED