10861747 (B.P.A.I. Jul. 13, 2010)

Ex Parte Farazi

Board of Patent Appeals and InterferencesJul 13, 2010

10861747 (B.P.A.I. Jul. 13, 2010)

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. 10/861,747 06/04/2004 Taraneh Ghaffari Farazi A04P3012-US1 1504 24473 7590 07/14/2010 STEVEN M MITCHELL PACESETTER INC 701 EAST EVELYN AVENUE SUNNYVALE, CA 94086 EXAMINER GEDEON, BRIAN T ART UNIT PAPER NUMBER 3766 MAIL DATE DELIVERY MODE 07/14/2010 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 BOARD OF PATENT APPEALS AND INTERFERENCES ____________ Ex parte TARANEH GHAFFARI FARAZI ____________ Appeal 2009-005655 Application 10/861,747 Technology Center 3700 ____________ Before JOHN C. KERINS, STEVEN D.A. McCARTHY and MICHAEL W. O’NEILL, Administrative Patent Judges. McCARTHY, Administrative Patent Judge. DECISION ON APPEAL1 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2009-005655 Application 10/861,747 2 The Appellant appeals under 35 U.S.C. § 134 from the Examiner’s 1 final decision rejecting claims 1-39 under 35 U.S.C. § 103(a) as being 2 unpatentable over Burnes (US 7,079,887 B2, issued Jul. 18, 2006) and 3 Schwartz (US 5,330,507, issued Jul. 19, 1994). An oral hearing was held on 4 June 23, 2010. We have jurisdiction over the appeal under 35 U.S.C. § 6(b). 5 We REVERSE. 6 Claims 1, 14, 27 and 34 are independent. Claim 1 is illustrative: 7 1. A method of assessing a patient’s risk 8 of sudden cardiac death (SCD), comprising: 9 stimulating the patient’s vagus nerve to 10 induce a drop in arterial blood pressure; and 11 measuring a degree of oscillatory behavior 12 in sinus rhythm following said stimulation, said 13 degree of oscillatory behavior being indicative of 14 the risk of SCD. 15 Burnes discloses a process for gauging the hemodynamic status of a 16 patient. (Burnes, col. 6, l. 64 – col. 7, l. 4). Burnes teaches that heart rate 17 and blood pressure turbulence resulting from premature ventricular 18 contractions (“PVCs”), premature atrial contractions and other abnormal 19 heartbeats may indicate hemodynamic status and overall cardiac health. 20 (Burnes, col. 2, ll. 32-37). In particular, Burnes teaches that a PVC or other 21 perturbation results in reduced arterial blood pressure and blood flow. The 22 reduced arterial blood pressure and blood flow results in heart rate 23 turbulence (“HRT”). (Burnes, col. 2, ll. 37-41). Burnes also teaches that 24 measuring HRT following a heart rate perturbation may help identify a 25 patient’s risk for SCD. (Burnes, col. 2, ll. 58-62). 26 Burnes’ process includes inducing cardiac perturbations such as 27 extrasystolic beats (atrial or ventricular) or PVCs. (Burnes, col. 7, ll. 64-67). 28 Appeal 2009-005655 Application 10/861,747 3 Burnes’ process further includes monitoring the patient’s reaction to the 1 perturbations to determine the rate and magnitude of any resulting HRT. 2 (Burnes, col. 8, ll. 15-19). 3 Schwartz teaches triggering stimulation of the vagal nerves in 4 response to elevation of the ST segment level above a threshold level 5 indicative of acute myocardial ischemia (insufficient oxygen supply to the 6 heart tissue). (Schwartz, col. 5, ll. 3-6). Schwartz states that: 7 The stimulation of the vagal nerves under these 8 circumstances acts indirectly on the carotid sinus 9 nerves and reduces both blood pressure level as 10 well as heart rate. This decreases myocardial 11 workload and so reduces anginal pain. Vagal 12 stimulation has a vasodilator effect, which 13 contributes to lower blood pressure. 14 (Schwartz, col. 5, ll. 6-12). 15 The Examiner reasons that: 16 Stimulation of the vagus nerve is a recognized 17 technique for inducing a change in the 18 hemodynamics of a patient, and is explicitly taught 19 to do so by Schwartz. In view of the teachings of 20 Schwartz, the Examiner considers . . . vagus nerve 21 stimulation to be an effective artificial perturbation 22 to cause a change in a patient’s hemodynamics as 23 required by Burnes et al., as well as required by 24 Appellant’s invention as claimed. One of ordinary 25 skill in the art would find it obvious to utilize 26 vagus nerve stimulation to create an oscillatory, 27 behavior such as HRT, because Burnes et al. teach 28 that HRT . . . results from the body’s attempt to 29 restore low blood pressure, wherein blood pressure 30 can be lowered by vagus nerve stimulation as 31 taught by Schwartz. 32 (Ans. 8). 33 Appeal 2009-005655 Application 10/861,747 4 As the Appellant points out (see Br. 17), Burnes and Schwartz do not 1 function in the same manner. Burnes teaches inducing an arrhythmia to 2 permit monitoring of the resulting HRT. Schwartz teaches vagal stimulation 3 to interrupt an arrhythmia or to reduce anginal pain. 4 The Examiner provides a scenario by which one practicing in the field 5 might have discovered how to stimulate HRT and detect susceptibility to 6 SCD by vagal stimulation. Nevertheless, the Examiner fails to provide 7 sufficient reasoning to show that this use of vagal stimulation would have 8 been obvious. The Examiner fails to provide a persuasive rational 9 underpinning for the conclusion that one of ordinary skill in the art would 10 have recognized that vagal stimulation, by lowering blood pressure, would 11 induce HRT. 12 It follows that there has been an insufficient showing that one of 13 ordinary skill in the art would have had reason to measure a degree of HRT 14 or oscillatory behavior in sinus rhythm following stimulation of the vagal 15 nerves. Neither has there been a sufficient showing that one of ordinary skill 16 in the art would have had reason to combine means for stimulating the 17 patient’s vagus nerve with means for processing the sinus rhythm response 18 to measure a degree of oscillatory behavior. The evidence and technical 19 reasoning underlying the rejections of claims 1, 14, 27 and 34 do not 20 adequately support the conclusion that the subject matter of those claims 21 would have been obvious. We do not sustain the rejections of independent 22 claims 1, 14, 27 and 34, or the rejections of the claims which depend from 23 them. 24 Appeal 2009-005655 Application 10/861,747 5 DECISION 1 We REVERSE the Examiner’s decision rejecting claims 1-39. 2 3 REVERSED 4 5 6 7 8 9 10 11 12 13 14 15 16 17 mls 18 19 20 21 STEVEN M MITCHELL 22 PACESETTER INC 23 701 EAST EVELYN AVENUE 24 SUNNYVALE, CA 94086 25