Ex Parte Giftakis et alDownload PDFPatent Trial and Appeal BoardJun 23, 201612236316 (P.T.A.B. Jun. 23, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/236,316 09/23/2008 71996 7590 06/27/2016 SHUMAKER & SIEFFERT, P.A 1625 RADIO DRIVE, SUITE 100 WOODBURY, MN 55125 FIRST NAMED INVENTOR Jonathon E. Giftakis 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 1023-738US01/P0030295.0l 7673 EXAMINER NG, JONATHAN K ART UNIT PAPER NUMBER 3686 NOTIFICATION DATE DELIVERY MODE 06/27/2016 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): pairdocketing@ssiplaw.com medtronic _neuro _ docketing@cardinal-ip .com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Exparte JONATHON E. GIFTAKIS, JONATHAN C. WERDER, DAVID C. ULLESTAD, and NINA M. GRAVES Appeal2014-001251 1 Application 12/236,3162 Technology Center 3600 Before BIBHU R. MOHANTY, KENNETH G. SCHOPPER, and MATTHEWS. MEYERS, Administrative Patent Judges. MEYERS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's final rejection of claims 1-5, 8, 10-17, 19-32, 37--45, and 52---63. We have jurisdiction under 35 U.S.C. § 6(b ). We REVERSE. 1. Our decision references Appellants' Appeal Brief ("Appeal Br.," filed July 30, 2013) and Reply Brief ("Reply Br.," filed October 29, 2013), the Examiner's Answer ("Ans.," mailed August 29, 2013), and Final Office Action ("Final Act.," mailed March 1, 2013). 2. Appellants identify Medtronic, Inc. as the real party in interest (Appeal Br. 3). Appeal2014-001251 Application 12/236,316 CLAIMED INVENTION Appellants' claimed invention relates generally "to evaluating one or more therapy programs or groups of programs or adjusting therapy delivered by a medical device based on an indication that a patient event occurred" (Spec. ii 6). Claim 1, reproduced below with added bracketed notations, is illustrative of the subject matter on appeal: 1. A method comprising: [a] receiving, with at least one of a medical device programmer or a medical device, a plurality of indications, each indication of the plurality of indications indicating an occurrence of a patient event, wherein the patient event is related to a condition of the patient; [b] for each indication of the plurality of indications, generating, with at least one of the medical device programmer or the medical device, an event marker based on the respective indication of the occurrence of the patient event; [ c] with at least one of the medical device programmer or the medical device, associating each event marker \'l1ith at least one therapy program of a plurality of stored therapy programs, wherein the medical device is configured to deliver therapy to the patient according to the plurality of therapy programs, and wherein each therapy program of the plurality of stored therapy programs is associated with a respective threshold value, and at least two therapy programs are associated with different threshold values; [ d] determining, with at least one of the medical device programmer or the medical device, an event metric for a therapy program of the plurality of stored therapy programs based on a number of event markers associated with the therapy program; [ e] determining, with at least one of the medical device programmer or the medical device, whether the event metric indicates the therapy program is ineffective for the patient condition, and wherein determining whether the event metric indicates the therapy program is ineffective for the patient 2 Appeal2014-001251 Application 12/236,316 condition comprises comparing the event metric to the threshold value associated with the therapy program; and [ f] with at least one of the medical device programmer or the medical device, adjusting therapy delivered to the patient by the medical device in response to determining the event metric indicates the therapy program is ineffective for the patient condition. REJECTIONS Claims 1-5, 8, 10-17, 19, 20, 22, 24--32, 37-39, 41--45, and 52---63 are rejected under 35 U.S.C. § 103(a) as unpatentable over Snell (US 5,518,001, iss. May 21, 1996), Osorio (US 2004/0158119 Al, pub. Aug. 12, 2004), and Goetz (US 2005/0060007 Al, pub. Mar. 17, 2005). Claims 21and40 are rejected under 35 U.S.C. § 103(a) as unpatentable over Snell, Osorio, Goetz, and Smith (US 200710040692 Al, pub. Feb. 22, 2007). Claim 23 is rejected under 35 U.S.C. § 103(a) as unpatentable over Snell, Osorio, Goetz, and Eiffert (US 2002/0120187 Al, pub. Aug. 29, 2002). ANALYSIS We are persuaded by Appellants' argument that the Examiner erred in rejecting independent claim 1under35 U.S.C. § 103(a) because the combination of Snell, Osorio, and Goetz fails to disclose or suggest "a plurality of stored therapy programs ... , wherein each therapy program of the plurality of stored therapy programs is associated with a respective threshold value, and at least two therapy programs are associated with 3 Appeal2014-001251 Application 12/236,316 different threshold values," as recited by limitation [ c] of independent claim 1 (see Appeal Br. 10-12; see also Reply Br. 7-10). The Examiner maintains that the rejection is proper, and cites paragraphs 48 and 56, as well as Figure 5, of Goetz as disclosing the argued limitations (see Final Act. 2---6; see also Ans. 28-30). More particularly, the Examiner finds that "each therapy program has multiple threshold values and they are different than each other in value" (Ans. 29) and asserts that "under the broadest reasonable interpretation, one can interpret claim 1 to encompass where each therapy program is each associated with different threshold values" (id. at 30). Goetz "is directed to a technique for selection of parameter configurations for a neurostimulatar using decision trees" (Goetz i-f 6). More particularly, Goetz discloses that its "technique may be employed by a programming device to allow a clinician to select parameter configurations, and then program an implantable neurostimulator to deliver therapy using the selected parameter configurations" (id.). Goetz discloses that its programming device utilizes "a parameter configuration search algorithm" which "relies on a decision tree to identify potential optimum parameter configurations" (id. i-f 8). Goetz discloses that the "decision tree is useful in classifying observations in a data set based upon one or more attributes or fields within the data" (id. i-f 9) and "[t]he data set includes parameter configurations matched with observed ratings of efficacy on patients of a similar symptomatic indication" (id. i-f 1 O; see also id. i-f 11 ). In this regard, Goetz discloses partial decision trees of FIGS. 4 and 5 address the problem of selecting the optimum electrode configuration. The partial decision tree of FIG. 4 represents a first level of the decision tree 4 Appeal2014-001251 Application 12/236,316 hierarchy, and is directed to identification of therapy, device, lead and symptomatic indication. Specifically, the decision tree of FIG. 4 is design to identify the type of neurostimulation therapy ( 44) to be applied to the patient, e.g., therapy directed to pain relief (46), gastro disorders (48), movement disorders (50), or other disorders (52), such as sexual dysfunction. (Id. i-f 49). Goetz further discloses "the decision tree of FIG. 5 may start with a root node such as electrode combination LE23 (90), i.e., a combination of second and third electrodes on a left" and "[i]f the combination produces a satisfactory efficacy rating, the process terminates (92)" (id. i-f 56). Goetz also discloses (Id.). FIG. 5 uses a rating scale of 1 to 5, with 5 being best and 1 being worst. In some embodiments, nodes with ratings of less than 3 may be discarded, rather than expanded. If a rating of 5 is not achieved, then the root node 90 may be expanded to explore other combinations. We are not persuaded by the Examiner's analysis because, although Goetz discloses that different electrode combinations may be associated with different thresholds reflecting efficacy and side effects (see e.g., Goetz i-fi-155-58; see also id. at Fig. 5), as Appellants point out [c]laim 1 does not recite that at least two therapy programs are associated with multiple threshold values, as asserted by the Examiner. Rather, claim 1 specifies that each therapy program of the plurality of stored therapy programs is associated with a respective threshold value, and at least two therapy programs are associated with different threshold values. (Reply Br. 8). We also agree with Appellants that "paragraph [0056] of Goetz does not disclose that at least two electrode combinations are associated with different efficacy rating thresholds" (id. at 7); but rather, "Goetz describes 5 Appeal2014-001251 Application 12/236,316 application of the same efficacy rating threshold to expand the nodes of the decision tree, and thereby test additional electrode combinations" (id.). In this regard, we note that Goetz discloses that "ratings of 4 and 3 yield evaluation of additional next-level nodes 94, 96 directed to electrode combinations LE34 and RE34" (Goetz i-f 56; see also id. at Fig. 5). Thus, Goetz presents various treatment options using a sliding scale of likelihood of efficacy, but Goetz does not disclose or suggest "a plurality of stored therapy programs ... , wherein each therapy program of the plurality of stored therapy programs is associated with a respective threshold value, and at least two therapy programs are associated with different threshold values," as recited by limitation [ c] of independent claim 1. The Examiner does not rely on either of Snell or Osorio to address this limitation (see Final Act. 5- 6; see also Ans. 5---6). In view of the foregoing, we reverse the Examiner's rejection of independent claim 1. For the same reasons; we also do not sustain the Examiner's rejection of dependent claims 2-5, 8, 10-17, 19, 20, 22, and 24-- 26. Cf In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992) ("dependent claims are nonobvious if the independent claims from which they depend are nonobvious"). Independent claims 27 and 45, and dependent claims 28-32, 37-39, 41--45, and 52-63 Independent claims 27 and 45 include limitations substantially similar to independent claim 1 's limitations discussed above. Therefore, we do not sustain the Examiner's rejection under 35 U.S.C. § 103(a) of independent claims 27 and 45, and claims 28-32, 37-39, 41--45, and 52---63 that depend 6 Appeal2014-001251 Application 12/236,316 therefrom, for the same reasons set forth above with respect to independent claim 1. Dependent claims 21and40 Claims 21 and 40 depend from independent claims 1 and 27, respectively. The Examiner's rejection of claims 21 and 40 under 35 U.S.C. § 103(a) based on Smith, in combination with Snell, Osorio, and Goetz, does not cure the deficiency in the Examiner's rejection of independent claim 1. Therefore, we do not sustain the Examiner's rejection of claims 21 and 40 under 35 U.S.C. § 103(a) for the same reasons set forth above with respect to the independent claims. Dependent claim 23 Claim 23 depends from independent claim 1. The Examiner's rejection of claim 23 under 35 U.S.C. § 103(a) based on Eiffert, in combination with Snell, Osorio, and Goetz, does not cure the deficiency in the Examiner's rejection of independent claim 1. Therefore, we do not sustain the Examiner's rejection of claim 23 under 35 U.S.C. § 103(a) for the same reasons set forth above with respect to the independent claims. DECISION The Examiner's rejections of claims 1-5, 8, 10-17, 19-32, 37--45, and 52---63 under 35 U.S.C. § 103(a) are reversed. REVERSED 7 Copy with citationCopy as parenthetical citation