10443338 (B.P.A.I. Jul. 29, 2010)

Ex Parte Carlson et al

Board of Patent Appeals and InterferencesJul 29, 2010

10443338 (B.P.A.I. Jul. 29, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES ____________ Ex parte GERRARD M. CARLSON, KENNETH L. BAKER, and JEFFREY E. STAHMANN ____________ Appeal 2009-009663 Application 10/443,338 Technology Center 3700 ____________ Before LINDA E. HORNER, JENNIFER D. BAHR and STEVEN D.A. McCARTHY, 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 2009-009663 Application 10/443,338 2 STATEMENT OF THE CASE 1 The Appellants appeal under 35 U.S.C. § 134 from the Examiner’s 2 final decision rejecting claims 1, 2, 5-8, 10 and 12-20 under 35 U.S.C. § 112, 3 first paragraph, for failing to comply with the written description 4 requirement. We have jurisdiction over the appeal under 35 U.S.C. § 6(b). 5 We AFFIRM. 6 The Appellants’ claims relate to a cardiac rhythm management 7 method and system that uses atrial heart rate variability to provide a 8 diagnostic indication of patient well-being that reflects an autonomic balance 9 between the sympathetic and vagal components of the autonomic nervous 10 system. (Spec. 5, ll. 7-10). 11 Claims 1, 6 and 13 are independent. Claim 1 is illustrative: 12 1. A method of using a cardiac rhythm management device 13 including: 14 detecting, over a time period, intrinsic atrial heart contractions; 15 measuring P-P intervals between the intrinsic atrial heart 16 contractions; 17 calculating beat-to-beat P-P time differences between a pair of 18 successive P-P intervals; 19 categorizing each of the P-P time differences using: (1) a 20 magnitude of at least one P-P interval in the pair of successive P-P 21 intervals; and (2) an amount of the P-P time difference; and 22 providing a diagnostic using the categorized P-P time 23 differences when it is determined that at least one of the following 24 conditions exist: 25 (a) the cardiac rhythm management device is 26 operating in a non-atrial-rate-tracking mode; 27 (b) premature ventricular contractions are present; or 28 (c) the cardiac rhythm management device is 29 operating in a ventricular rate smoothing or stabilization mode. 30 Appeal 2009-009663 Application 10/443,338 3 ISSUE 1 The sole issue in this appeal is: 2 Does the written description provide support for 3 providing a diagnostic using the categorized P-P time 4 differences when it is determined that at least one of the 5 following conditions exist: (a) the cardiac rhythm management 6 device is operating in a non-atrial-rate-tracking mode; (b) 7 premature ventricular contractions are present; or (c) the cardiac 8 rhythm management device is operating in a ventricular rate 9 smoothing or stabilization mode? 10 11 FINDINGS OF FACT 12 The record supports the following findings of fact (“FF”) by a 13 preponderance of the evidence. 14 1. We adopt and incorporate by reference the Examiner’s findings 15 at page 7, lines 7-15 and 19-20 of the Examiner’s Answer. 16 2. The Specification states at page 12, lines 5-13, that: 17 Moreover, even when the cardiac rhythm 18 management system is operating in a mode that 19 tracks atrial heart rate, ventricular heart rate 20 variability data requires that R-R intervals 21 associated with premature ventricular contractions 22 (PVCs) be ignored. This reduces the amount of 23 available data upon which a diagnosis is based. By 24 contrast, the present atrial heart rate variability 25 diagnostic techniques can make use of data from 26 all atrial heart contractions, which increases the 27 available data for making the diagnosis, and 28 reduces the complexity of making the diagnosis, 29 since techniques for ignoring PVC's are not 30 needed. 31 Appeal 2009-009663 Application 10/443,338 4 3. The Specification discusses in similar terms the need for a 1 cardiac rhythm management system operating in a mode that tracks atrial 2 heart rate to ignore R-R intervals associated with PVCs at page 4, lines 20-3 25 and page 5, lines 12-15. 4 5 PRINCIPLES OF LAW 6 The Appellants correctly argue that “there is no in haec verba 7 requirement, but newly added claim limitations must be supported in the 8 specification through express, implicit, or inherent disclosure.” (App. Br. 9 10). Nevertheless, in order to comply with the written description 10 requirement, the Specification must convey with reasonable clarity to those 11 skilled in the art that, as of the filing date sought, the Appellant was in 12 possession of the subject matter as now claimed. Ariad Pharm., Inc. v. Eli 13 Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)(citing Vas-Cath, Inc., v. 14 Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991)). 15 16 ANALYSIS 17 The Appellants contend that: 18 the specification as-filed indicates (and one of 19 ordinary skill in the art would understand) that 20 information as to whether conditions [such as 21 conditions (a), (b) and (c) recited in claims 1, 6 and 22 13] exist is readily available in a cardiac rhythm 23 management system controller – and the present 24 patent application more than adequately teaches 25 the particular conditions under which the atrial 26 HRV techniques should be applied. 27 (App. Br. 12) (emphasis added). 28 Appeal 2009-009663 Application 10/443,338 5 Consider, for example, the alternative where a method as recited in 1 claim 1 provides a diagnostic using the categorized P-P time differences 2 when it is determined that (b) premature ventricular contractions are present, 3 alone or in combination with one or both of conditions (a) and (c). The 4 Examiner correctly finds that the sentence at page 12, lines 9-13 of the 5 Specification (see FF 2 at page 3, lines 24-31 supra) contradicts the 6 Applicants’ contention that the passage shows possession of such a method. 7 More specifically, the last sentence of the passage states that techniques for 8 ignoring PVCs are not needed when using the Appellants’ atrial heart rate 9 variability diagnostic techniques. As the Examiner correctly finds, “[t]he 10 system is not concerned with determining anything in regards to the 11 ventricles, least of all providing a diagnostic when a ventricular event 12 occurs.” (Ans. 7, adopted and incorporated by reference in FF 1). This 13 teaching of the Appellants’ Specification would have suggested that the 14 Appellants were not in possession of a method combining a step of 15 providing a diagnostic using the categorized P-P time differences when it is 16 determined that (b) premature ventricular contractions are present, alone or 17 in combination with one or both of conditions (a) and (c), with an atrial heart 18 rate variability diagnostic technique. 19 The Specification teaches that, “even when [a] cardiac rhythm 20 management system is operating in a mode that tracks atrial heart rate, R-R 21 intervals that are associated with [PVCs] must typically be ignored in any 22 determination of sympathetic/parasympathetic balance based on ventricular 23 heart rate variability.” (Spec. 4, ll. 20-25). This passage identifies a 24 problem with the determination of sympathetic/parasympathetic balance 25 based on ventricular heart rate variability but not necessarily a problem with 26 Appeal 2009-009663 Application 10/443,338 6 a method including the steps of detecting, over a time period, intrinsic atrial 1 heart contractions; measuring P-P intervals between the intrinsic atrial heart 2 contractions; calculating beat-to-beat P-P time differences between a pair of 3 successive P-P intervals; and categorizing each of the P-P time differences 4 using: (1) a magnitude of at least one P-P interval in the pair of successive P-5 P intervals; and (2) an amount of the P-P time difference. 6 Even if the Appellants’ written description indicated a problem with a 7 method including these steps, it does not describe solving this problem by 8 combining these steps with a step of providing a diagnostic using the 9 categorized P-P time differences when it is determined that (b) premature 10 ventricular contractions are present, alone or in combination with one or 11 both of conditions (a) and (c). While the disclosure of this problem might 12 have provided one of ordinary skill in the art apparent reason to modify a 13 method or system which used “atrial heart rate variability to provide a 14 diagnostic indication of patient well-being” as described in the Appellants’ 15 Specification (see Spec. 5, ll. 7-10) such that the method also included the 16 step of providing a diagnostic using the categorized P-P time differences 17 when it is determined that (b) premature ventricular contractions are present, 18 alone or in combination with one or both of conditions (a) and (c), merely 19 rendering the claimed subject matter obvious would not have described that 20 subject matter, expressly or implicitly. Lockwood v. Am. Airlines, Inc., 107 21 F.3d 1565, 1571-72 (Fed. Cir. 1997). 22 The lack of support for the step of providing a diagnostic using the 23 categorized P-P time differences when it is determined that (b) premature 24 ventricular contractions are present, alone or in combination with one or 25 both of conditions (a) and (c), supports the Examiner’s finding that the 26 Appeal 2009-009663 Application 10/443,338 7 subject matter of claim 1 was not described in the Specification in such a 1 way as to reasonably convey to one skilled in the relevant art that the 2 Appellants, at the time the application was filed, had possession of the 3 invention as claimed in claim 1. Similar reasoning supports the Examiner’s 4 finding that the subject matter of claims 6 and 13 was not described in the 5 Specification in such a way as to reasonably convey to one skilled in the 6 relevant art that the Appellants, at the time the application was filed, had 7 possession of the invention as claimed in claims 6 and 13. We sustain the 8 rejections of independent claims 1, 6 and 13 under § 112, first paragraph, for 9 failing to comply with the written description requirement. We sustain the 10 rejections of dependent claims 2, 5, 7-8, 10, 12, and 14-20 due to the 11 dependency of each on one of claims 1, 6 and 13. 12 13 DECISION 14 We AFFIRM the Examiner’s decision rejecting claims 1, 2, 5-8, 10 15 and 12-20. 16 No time period for taking any subsequent action in connection with 17 this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. 18 § 1.136(a)(1) (2009). 19 20 AFFIRMED 21 22 23 mls 24 25 26 SCHWEGMAN, LUNDBERG & WOESSNER/BSC-CRM 27 PO BOX 2938 28 MINNEAPOLIS, MN 55402 29