Ex Parte Zhou

Patent Trial and Appeal BoardNov 8, 2012

11536946 (P.T.A.B. Nov. 8, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte XIAOHONG ZHOU ____________ Appeal 2010-009798 Application 11/536,946 Technology Center 3700 ____________ Before JOHN C. KERINS, MICHAEL C. ASTORINO, and JEREMY M. PLENZLER, Administrative Patent Judges. PLENZLER, Administrative Patent Judge. DECISION ON APPEAL Appeal 2010-009798 Application 11/536,946 2 STATEMENT OF THE CASE Appellant seeks our review under 35 U.S.C. § 134 of the Examiner’s decision rejecting claims 1-29 under 35 U.S.C. § 103(a) as being unpatentable over Levine (US 6,865,414 B1; iss. Mar. 8, 2005) and Park (US 7,027,867 B2; iss. Apr. 11, 2006). We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. CLAIMED SUBJECT MATTER Appellant’s claimed invention relates to T-wave alternans assessment. “T-wave alternans is beat-to-beat alternation in the morphology, amplitude, and/or polarity of the T-wave, and can be observed on surface electrocardiogram (ECG) recordings.” Spec. 1, para. [03]. Claims 1, 15, and 16 are independent. Claim 1, reproduced below, is illustrative: 1. A method, comprising: identifying a premature contraction in the heart of a patient; sensing a cardiac signal from an implanted electrode subsequent to the premature contraction; measuring a T-wave parameter from the sensed cardiac signal for a plurality of cardiac cycles in response to identifying the premature contraction; and determining a T-wave alternans metric corresponding to the measured T-wave parameter. Appeal 2010-009798 Application 11/536,946 3 OPINION Claim 1 recites a method including “identifying a premature contraction in the heart of a patient,” “sensing a cardiac signal . . . subsequent to the premature contraction,” and “measuring a T-wave parameter from the sensed cardiac signal . . . in response to identifying the premature contraction.” Claim 15 recites a computer-readable medium for storing a set of instructions to “identify a premature contraction in the heart of a patient,” “sense a cardiac signal . . . subsequent to the premature contraction,” and “measure a T-wave parameter from the sensed cardiac signal.” Claim 16 recites a system including “an implanted electrode for sensing cardiac signals” and a “processor identifying a premature contraction in the heart of a patient and measuring a T-wave parameter from the sensed cardiac signals in response to identifying the premature contraction.” The Examiner determined that “Levine et al. discloses a method, computer-readable medium and a system for storing sets of instructions and identifying premature contractions in the heart.” Ans. 3. The Examiner acknowledges that Levine does not disclose measuring T-wave parameters or determining a T-wave metric. Id. Instead, the Examiner relies on Park as disclosing “a morphology detector (62) [that] measures the magnitude of a T-wave characteristic of each T-wave . . . to determine a T-wave alternan pattern.” Ans. 3-4. The Examiner further notes that the “morphology detector [in Park] measures the magnitude of the T-wave characteristic of T- Appeal 2010-009798 Application 11/536,946 4 waves occurring during consecutively paced cardiac cycles.” Ans. 4. The Examiner concludes that it would have been obvious to modify Levine with the T-wave measurement evaluation of Park “for providing the predictable results pertaining to providing precursors for sudden cardiac death by detecting T-wave alternan patterns and delivering a corresponding electrical therapy to a patient’s heart.” Id. Claims 1, 15, and 16 are each rejected on the same grounds. See Ans. 3-4. Appellant explains that “the essence of the invention is the recognition of the correlation between premature ventricular contractions and T-wave alternans, and the nature of the relationship between premature ventricular contractions and T-wave alternans as being predictive of broader cardiac conditions.” Br. 12. Sensing the cardiac signals and assessing the T-waves occur after the premature contraction is identified because the premature contraction is used as an indication of an increased likelihood of a T-wave alternans occurrence. See Br. 8. Appellant asserts that “[t]he Examiner provides no objective teaching in the art why this is an obvious development, [and] instead merely plac[es] two references together and say[s] it would have been obvious to combine them.” Br. 12. Appellant further asserts that: neither Levine et al '414 nor Park et al '867 show, disclose or suggest measuring a T-wave parameter from a sensed cardiac signal in response to identifying a premature contraction and determining a T-wave alternans metric corresponding to the measured T-wave parameter. As such, neither Levine et al '414 Appeal 2010-009798 Application 11/536,946 5 nor Park et al '867, alone or in combination, show, disclose or suggest at least one essential element of claim 1. Id. Although the Examiner articulated a reason to modify Levine in view of Park, namely, for providing predictable results pertaining to providing precursors for sudden cardiac death, the reasoning fails to articulate why one skilled in the art would identify a premature heart contraction, subsequently sense a cardiac signal, and measure a T-wave parameter from the sensed cardiac signal for a plurality of cardiac cycles. Claims 1 and 15 each include sensing “a cardiac signal . . . subsequent to the premature contraction” and measuring “a T-wave parameter from the sensed cardiac signal.” Claim 16 includes “measuring the T-wave parameter for a plurality of cardiac cycles subsequent to the premature contraction.” The Examiner has not cited Levine for any teachings directed to T-wave assessment. Instead, Park is cited as disclosing the claimed T-wave measurement and evaluation. See Br. 3-4. However, Park includes “a timer that activates the [T-wave alternans pattern] detection at spaced apart times” and “[a]lternatively, or in addition, the system may further include an activity detector that detects when the patient is at rest and which enables the detection only when the patient is at rest.” Col. 2, ll. 37-41. Neither Park nor Levine addresses the claimed identification of a premature heart contraction as the basis for initiating a T-wave alternans assessment and the Examiner has failed to articulate reasoning pertaining to why one skilled in the art would identify a premature contraction before assessing T-wave parameters based on the combination of Levine and Park. Appeal 2010-009798 Application 11/536,946 6 Therefore, we cannot find that the Examiner’s conclusion of obviousness is based on rational underpinnings. For this reason, we do not sustain the rejection of claims 1-29 under 35 U.S.C. § 103(a) as being unpatentable over Levine and Park. DECISION We REVERSE the rejection of claims 1-29 under 35 U.S.C. § 103(a) as being unpatentable over Levine and Park. REVERSED mls