Ex Parte Keefe et alDownload PDFPatent Trial and Appeal BoardMay 19, 201713491492 (P.T.A.B. May. 19, 2017) Copy Citation 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. 13/491,492 06/07/2012 James M. Keefe 1001.3709101 9947 11050 7590 05/23/2017 SEAGER, TUFTE & WICKHEM, LLP 100 South 5th Street Suite 600 Minneapolis, MN 55402 EXAMINER WEHRHEIM, LINDSEY GAIL ART UNIT PAPER NUMBER 3762 NOTIFICATION DATE DELIVERY MODE 05/23/2017 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): BSC.USPTO@stwiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAMES M. KEEFE and RICK SANGHERA1 Appeal 2016-001933 Application 13/491,492 Technology Center 3700 Before JEFFREY N. FREDMAN, TIMOTHY G. MAJORS, and RACHEL H. TOWNSEND, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a method and apparatus for providing cardiac rhythm management (CRM), which have been rejected as anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellants identify the Real Party in Interest as Cameron Health, Inc., a subsidiary of Boston Scientific Corporation. (App. Br. 3.) Appeal 2016-001933 Application 13/491,492 STATEMENT OF THE CASE Appellants’ “invention relates to ventricular tachyarrhythmia management in implantable therapy systems.” (Spec. 12.) According to the Specification, “[a]nti-tachycardia pacing (ATP) is a method of rapid pacing used in an attempt to terminate rapid tachycardias. ... A typical use for ATP is to attempt to terminate ventricular tachyarrhythmia (VT).” {Id. at 114.) The Specification describes a form of VT called “monomorphic VT (MVT) in which a similar beat-to-beat conduction pattern is noted” and is “caused by an electrical loop within the cardiac muscle.” {Id. at 115.) This electrical loop is referred to as the “reentrant circuit.” {Id.) The Specification discloses: Conventional CRM systems utilize electrodes which are placed in or on the heart for sensing and to pace and shock the heart. The most common such system is a transvenous system, which uses a lead that is threaded through the vasculature and into the heart for attachment in a heart chamber or in a blood vessel of the heart itself. Before the advent of transvenous technology, systems were placed epicardially, with electrodes placed on exterior of the heart in an open-chest surgery. {Id. at 13.) As explained in the Specification “[djelivery of a pacing pulse using only subcutaneous electrodes that do not touch the heart has a less localized effect on the heart than prior conventional transvenous or epicardial pacing systems.” {Id. at 120.) Also, “[b]y delivery of pacing with subcutaneous electrodes, a global capture of the cardiac tissue is achieved.” {Id.) According to the Specification, “[t]he inventors have recognized that this global capture can take away the variability inherent in the proximity- 2 Appeal 2016-001933 Application 13/491,492 dependence of the transvenous or epicardial approach to ATP.” (Id.) And, more specifically, “rather than a long pulse train of ATP delivered from transvenous or epicardial electrodes, the present invention . . . breaks a reentrant circuit with just one or two pulses delivered by subcutaneous electrodes. This therapy is referred to herein as single termination pulse (STP) therapy which can be delivered subcutaneously, rather than transvenously or epicardially.” (Id. at 121; see also id. at 134 (“STP and ATP are distinguished from one another by the following rules: . . . delivery of one or more sets of 1-4 pulses separated by assessment of the success of the previous pulses, is considered STP.”).) Claims 1, 2, 4—6, and 8 are on appeal. Claim 1 is illustrative: 1. A method of treating a patient in an implantable cardiac rhythm management device (CRMD) comprising a canister housing circuitry for performing data analysis and therapy delivery, coupled to a lead electrode having electrodes for body implantation suitable for sensing electrical signals, the method comprising: receiving cardiac signals from the patient using one or more of the electrodes on the lead; identifying that a tachycardia is occurring based on the received cardiac signals showing a cardiac rate in excess of a rate threshold; determining that the tachycardia is not supraventricular in nature and declaring a treatable episode of tachycardia; determining that the tachycardia is monomorphic; delivering one to four synchronized pacing pulses to the patient using far-field electrodes in response to the monomorphic tachycardia; calculating the cardiac rate of the patient following the delivery of the one to four synchronized pacing pulses; 3 Appeal 2016-001933 Application 13/491,492 determining that the cardiac rate dropped in response to the one to four synchronized pacing pulses; and terminating the episode. (App. Br. 14 (Claims App’x).) The claims stand rejected as follows: I. Claims 1 and 5 as anticipated under 35 U.S.C. § 102(b) by Adams2 (“Rejection I”). II. Claims 2 and 6 under 35 U.S.C. § 103(a) over Adams and Bardy3 (“Rejection II”). III. Claims 4 and 8 under 35 U.S.C. § 103(a) over Adams (“Rejection III”). I-ANTICIPATION The Examiner rejected claims 1 and 5 as anticipated by Adams. The Examiner finds that Adams discloses, inter alia, delivering one to four synchronized pacing pulses to the patient using far-field electrodes in response to monomorphic tachycardia (col 1, In 60-68, col 8, In 25-32, where Adams clarifies in col 2, In 15-22 that the far-field electrodes as disclosed are also used to provide defibrillation pulses as well as pacing pulses. (Final Act. 3.) The Examiner further finds that Adams teaches “calculating the cardiac rate of the patient following the delivery of one to four synchronized pacing pulses” as required in claim 1 because “Examiner 2 Adams et al., US 5,366,487, issued Nov. 22, 1994. 3 Bardy et al., US 2002/0091414 Al, published July 11, 2002. 4 Appeal 2016-001933 Application 13/491,492 interprets that the system of Adams performs the disclosed procedure on a continuous basis and necessarily recalculates cardiac rate at a time point after delivery of pacing stimulation.” {Id. (citing Adams 8:7—36).) And, according to the Examiner, the “claims as currently worded do not require a specific order of steps, nor require a relationship between pacing pulse delivery and the determined cardiac data.” {Id.) Appellants raise several arguments. Appellants argue “[cjlaim 1 specifically recites the pacing pulses are delivered from far-field electrodes” and this claim element is not disclosed in Adams. (App. Br. 6.) At best, according to Appellants, Adams discloses that one of the defibrillation electrodes may serve as a common electrode to provide pacing or pulse detection, in addition to defibrillation. {Id.) As Appellants explain, “[t]his means the other electrode would still be a near field electrode located in or on the heart” and, thus, not teach that pacing pulses are provided by far-field electrodes {plural) as required by claim 1. {Id. at 6—7.) Appellants also argue “claims 1 and 5 specifically recite rate recalculation must occur in response to the delivery of the pacing therapy” and that this and other claim elements following the delivery of pulses are absent in Adams. (App. Br. 7.) Appellants further argue the claims require not just pacing pulses but “synchronized pacing pulses.” (App. Br. 10.) According to Appellants, the Examiner has, in effect, read the term “synchronized” out of the claim. {Id.; see also Reply Br. 3—4.) For the reasons discussed below and on this record, we conclude that Appellants have the better position. 5 Appeal 2016-001933 Application 13/491,492 Adams does not provide a clear teaching of an apparatus or method using at least two far-field electrodes that deliver one to four synchronized pacing pulses as required in claims 1 and 5. We recognize, but are not persuaded by, the Examiner’s response that Adams suggests the use of additional electrodes and the Examiner’s assertion that Adams’ “system is intended to use electrodes for multiple purposes, including defibrillation and pacing.” (Ans. 4 (citing Adams 3:9-13 and 5:64—66).) As Appellants point out, in context, Adams’ disclosure concerning adding electrodes (e.g., subcutaneous-patch electrodes) appears to provide additional channels for sensing signals — not delivering pacing pulses in the way that is claimed. (Reply Br. 2.) Moreover, although the portion of column 5 cited by the Examiner includes a generic disclosure regarding a potential use of electrodes for multiple purposes, this is a rejection under § 102(b). Net MoneylN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008) (To anticipate “it is not enough that the prior art reference discloses part of the claimed invention, which an ordinary artisan might supplement to make the whole, or that it includes multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.”).4 Whether claims 1 or 5 would have been obvious over Adams is not the issue before us. 4 For anticipation purposes, the “reference must clearly and unequivocally disclose the claimed compound or direct those skilled in the art to the compound without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference. Such picking and choosing may be entirely proper in the making of a 103, obviousness rejection . . . but it has no place in the making of a 102, anticipation rejection.” In reArkley, 455 F.2d 586, 587 (CCPA 1972) (emphasis in original). 6 Appeal 2016-001933 Application 13/491,492 We also disagree with the Examiner’s determination that no order of steps is required by claim 1. For example, the step of “calculating the cardiac rate of the patient following the delivery of the one to four synchronized pacing pulses” logically and literally must follow the prior step of delivering pulses. (App. Br. 7.) The Examiner asserts that “Adams is drawn to a continuous monitoring and treatment by the system.” (Ans. 5.) But the Examiner fails to direct us to any clear and persuasive support in Adams for this assertion. It might well be obvious to repeat Adams’ diagnostic steps after a shock is delivered, but again the rejection is for anticipation, not obviousness. And the present record lacks findings or reasoning of the Examiner supporting a § 103 rejection of claims 1 or 5. Finally, we agree with Appellants that the Examiner’s interpretation of “synchronized” is not reasonable.5 According to the Examiner, the “claim as currently worded does not clarify what the pacing pulse is synchronized to” and thus the Examiner interprets the term to encompass a 5 Appellants also argue that “cardioversion [in Adams] is not pacing” as claimed. (App. Br. 10.) In support, Appellants contend “[cjardioversion is applied at about 1 Joule using transvenous electrodes in Adams, an order of magnitude stronger than pacing as described in Applicants’ specification from a subcutaneous-only system.” {Id. at 9.) Inasmuch as Appellants seek to distinguish cardioversion and the pacing pulses that are claimed based on the amount of energy applied alone, we are not persuaded. We note, for example, that Appellants’ Specification also suggests pacing pulses at higher energies, including above 1 Joule. (See Spec. 130 (“Various amplitudes and signal types may apply instead, for example . . . waveforms delivering a particular amount of energy,from 0.01 Joules to 5 Joules, for example.”) and 134 (“STP therapy is different from defibrillation or cardioversion therapy in that the output is much smaller in energy level {often less than a Joule of energy).”) (emphases added).) 7 Appeal 2016-001933 Application 13/491,492 “shock [that] is synchronized with the identification of the tachycardia” as allegedly disclosed in Adams. (Ans. 6.) Although we give claim terms their broadest reasonable interpretation during prosecution, that does not include an interpretation divorced from the Specification. In re Skvorecz, 580 F.3d 1262, 1267 (Fed. Cir. 2009) (“The protocol of giving claims their broadest reasonable interpretation during examination does not include giving claims a legally incorrect interpretation.”) As Appellants persuasively argued, the meaning of “synchronized” in the claims and Specification means the pacing pulses are synchronized with the heart beat — in particular, a QRS signal. (Reply Br. 4; see also Spec. 136 (“STP therapy may be delivered either synchronized with or offset by a few milliseconds from the peak of a QRS signal”) (emphasis added).)6 So interpreted, the Examiner has not shown that Adams discloses “synchronized pacing pulses” as required in claims 1 and 5. For the above reasons, we conclude the Examiner did not establish by a preponderance of the evidence that Adams anticipates claims 1 or 5. II & III - OBVIOUSNESS The Examiner rejected claims 2 and 6 over Adams and Bardy (Rejection II), and claims 4 and 8 as obvious over Adams (Rejection III). 6 Appellants also persuasively argued that the Examiner’s interpretation would make other claim language redundant because the “delivering one to four synchronized pacing pulses” limitation already requires delivery of the pulses “in response to the monomorphic tachycardia.” (Reply Br. 4.) See Stumbo v. Eastman Outdoors, Inc., 508 F.3d 1358, 1362 (Fed. Cir. 2007) (rejecting construction that makes claim terms superfluous). 8 Appeal 2016-001933 Application 13/491,492 With respect to Rejection II, the Examiner finds that Adams does not disclose “a subcutaneous-only CRMD” and turns to Bardy. (Final Act. 4.) According to the Examiner, “Bardy discloses it was known in the art to implement a subcutaneous-only CRMD for pacing and defibrillation purposes.” (Id.) The Examiner has not, however, shown that Bardy makes up for the deficiencies of Adams noted above with respect to claims 1 and 5, from which claims 2 and 6 depend, respectively. Accordingly, we reverse Rejection II for the reasons provided concerning Rejection I. With respect to Rejection III, the Examiner finds Adams discloses “the rate threshold is in the range of 60-120 beats per minute” but “does not explicitly disclose the range is 120-220 beats per minute” as recited in dependent claims 4 and 8. (Id. at 5.) The Examiner concludes that a modification of the range would have been obvious as a matter of routine optimization or design choice. (Id.) The Examiner did not, however, provide any findings or reasoning that make up for the deficiencies of Adams discussed above concerning claims 1 and 5, from which claims 4 and 8 depend, respectively. Accordingly, we reverse Rejection III for the reasons provided concerning Rejection I. SUMMARY We reverse the rejection of claims 1 and 5 as anticipated under 35 U.S.C. § 102(b) by Adams. We reverse the rejection of claims 2 and 6 as obvious under 35 U.S.C. § 103(a) by Adams and Bardy. 9 Appeal 2016-001933 Application 13/491,492 We reverse the rejection of claims 4 and 8 as obvious under 35 U.S.C. § 103(a) over Adams. REVERSED 10 Copy with citationCopy as parenthetical citation