Ex Parte Giftakis et alDownload PDFPatent Trial and Appeal BoardNov 17, 201612432268 (P.T.A.B. Nov. 17, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/432,268 0412912009 71996 7590 11/21/2016 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. 1023-829US01/P0033947.00 6759 EXAMINER CATINA, MICHAEL ANTHONY ART UNIT PAPER NUMBER 3735 NOTIFICATION DATE DELIVERY MODE 11/21/2016 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 ExparteJONATHONE. GIFTAKIS andNATHAN A. TORGERSON Appeal2014-008524 Application 12/432,268 Technology Center 3700 Before JENNIFER D. BAHR, GEORGE R. HOSKINS, and LEE L. STEPINA, Administrative Patent Judges. HOSKINS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Jonathon E. Giftakis and Nathan A. Torgerson ("Appellants") 1 appeal under 35 U.S.C. § 134 from the Examiner's decision rejecting claims 12-14, 17-21, 32-34, 37-39, 42, 44--49, 52-58, 61-66, and 69-71 in this application. The Board has jurisdiction over the appeal under 35 U.S.C. § 6(b ). We REVERSE. 1 The Appeal Brief identifies Medtronic, Inc. as the real party in interest. Appeal Br. 3. Appeal2014-008524 Application 12/432,268 CLAIMED SUBJECT MATTER Claims 12, 32, and 42 are independent. Claim 12 illustrates the claimed subject matter on appeal, and it recites: 12. A method comprising: receiving, with a processor, a first signal indicative of a physiological parameter of a patient; receiving, with the processor, a second signal indicative of a patient parameter of the patient; and adjusting, with the processor, a seizure detection algorithm of a medical device based on the first and second signals, wherein adjusting the seizure detection algorithm comprises: identifying, with the processor, a target seizure based on the second signal; determining, with the processor, whether the medical device, while implementing the seizure detection algorithm, identified the target seizure based on the first signal; in response to determining that the medical device did not identify the target seizure based on the first signal, determining \~1hether a portion of the first signal associated with the target seizure is indicative of a baseline non- seizure state of the patient; and adjusting the seizure detection algorithm if the portion of the first signal associated with the target seizure is not indicative of the baseline non-seizure state of the patient. REJECTIONS ON APPEAL Claims 12-14, 17, 32-34, 42, 44--46, 52, 56, 57, 64, 65, and 69 stand rejected under 35 U.S.C. § 102(e) as anticipated by Leyde (US 2009/0171168 Al, pub. July 2, 2009). Claims 18, 19, 37, 53, 61, and 71 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Leyde and Donoghue (US 2005/0203366 Al, pub. Sept. 15, 2005). 2 Appeal2014-008524 Application 12/432,268 Claims 20, 38, and 47 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Leyde and Giftakis (US 2006/0135877 Al, pub. June 22, 2006). Claims 21, 39, and 48 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Leyde, Giftakis, and Donoghue. Claims 49, 58, and 66 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Leyde and Nathan (US 2012/0053491 Al, pub. Mar. 1, 2012). Claims 54, 62, and 70 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Leyde and Greene (US 2008/0319335 Al, pub. Dec. 25, 2008). Claims 55 and 63 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Leyde and Osorio (US 6,560,486 B 1, iss. May 6, 2003). ANALYSIS A. Anticipation by Leyde Claims 12-14, 17, 56, and 57 In rejecting claim 12, the Examiner finds Leyde discloses the claimed "first signal" as monitored neurological EEG data. Final Act. 3 (citing Leyde i-fi-128, 31 ). The Examiner finds Leyde discloses the claimed "second signal" as monitored clinical manifestation data, for example convulsions or ictal moans, which "identify[] ... a target seizure" occurrence as claimed. Id. (citing Leyde i-fi-128, 33, 40, 97-98); see also Leyde i130 ("ictal state" is "a state in which a neurological event, such as a seizure, is occurring"). The Examiner finds Leyde discloses the claimed "determining ... whether the medical device ... identified the target seizure based on the first signal" 3 Appeal2014-008524 Application 12/432,268 when Leyde compares the clinical manifestation data with the EEG data to determine if the device correctly predicted or determined a seizure state based on the EEG data. Final Act. 3 (citing Leyde i-fi-197-98). The Examiner finds Leyde discloses the claimed "in response to determining that the medical device did not identify the target seizure based on the first signal [i.e. EEG data], determining whether a portion of the first signal [i.e. EEG data] associated with the target seizure is indicative of a baseline non-seizure state of the patient" (with emphasis added to claim language). Id. at 3--4 (citing Leyde i-fi-1 30, 97-98). In particular, the Examiner determines Leyde' s analysis of the EEG data to see if the EEG seizure detection algorithm should be corrected "is equivalent to determining if the [EEG] signal is indicative of a non-seizure state, i.e.[,] the EEG is normal," and "[t]hen the algorithm is corrected, if necessary, for example if the device did not accurately predict or a detect a seizure state" based on the EEG data. Id. at 4 (citing Leyde i198). The Examiner further states the claimed "baseline" state "is arbitrary and does not differentiate ... from a non-seizure state," and "[a]ny non-seizure state or activity would generally be considered a baseline state as normal EEG activity is not ictal or epileptiform activity." Id. at 16. Appellants argue the Examiner errs in finding Leyde discloses both of the determining steps recited in claim 12. Appeal Br. 8-9; Reply Br. 7-8. Appellants also argue the Examiner errs in interpreting "the claimed 'baseline non-seizure state' as equivalent to any non-seizure state." Appeal Br. 11. We agree with these arguments. First, as a matter of claim construction, claim 12 recites "determining .... whether the medical device, while implementing the 4 Appeal2014-008524 Application 12/432,268 seizure detection algorithm, identified the target seizure based on the first signal" (hereafter "first determination"). Appeal Br. 27 (Claims App.). Claim 12 then recites, "in response to" the first determination indicating the device did not identify the target seizure based on the first signal, "determining whether a portion of the first signal associated with the target seizure is indicative of a baseline non-seizure state of the patient" (hereafter "second determination"). Id. (emphasis added). The separateness of these first and second determinations is established by the second determination being made "in response to" a specified result of the first determination. Further, both of the first and second determinations are made with respect to the claimed "first signal," which the Examiner finds to be Leyde's neurological EEG data. Final Act. 3. Thus, to anticipate claim 12, Leyde must disclose firstly determining whether its seizure detection algorithm identified a target seizure based on the EEG neurological data, and then secondly (i.e., in response to determining that the algorithm did not identify the target seizure) determining whether a portion of the EEG neurological data is indicative of a baseline non-seizure state. The Examiner's rejection conflates these two steps in finding both steps are met by the one action of determining whether Ley de' s seizure detection algorithm reports a seizure state or a non-seizure (i.e. normal) state based on the neurological EEG data. See Final Act. 3--4, 16-17; Ans. 16- 17. Further, the Examiner's construction of the claimed "baseline non- seizure state" as encompassing "[a]ny non-seizure state or activity" (Final Act. 16) is unreasonably broad, in light of the language of claim 12 and Appellants' supporting Specification. As to the claim language, claim 12 5 Appeal2014-008524 Application 12/432,268 recites the second determination-that is, the baseline non-seizure state determination-is made "in response to determining that the medical device did not identifj; the target seizure." Appeal Br. 27 (emphases added). Thus, as recited in the claim, the baseline non-seizure state determination is made based on the EEG data only after it has already been determined that the EEG data algorithm did not identify a target seizure state. As claimed, the baseline non-seizure state must be different from another non-seizure state or activity. That is, the word "baseline" specifies a type of non-seizure state. That understanding is consistent with Appellants' Specification, which differentiates the "baseline state" from an "abnormal" state, where both of those states are non-seizure states. Spec. i-fi-f 108-111, 141. The Specification indicates differentiating between those two types of non- seizure states is useful to "confirm" that the identification of a target seizure based on the second signal (e.g., the convulsion I ictal moan activity signal) was not a false positive. Id. A baseline non-seizure state suggests the claimed "identifying ... a target seizure state based on the second signal" may be a false positive, whereas an abnormal non-seizure state suggests the claimed "not identify[ing] the target seizure based on the first signal" may be a false negative. 2 Id. For the foregoing reasons, we do not sustain the rejection of claim 12, and of claims 13, 14, 17, 56, and 57 depending from claim 12, as anticipated byLeyde. 2 The Examiner states "[i]fthe baseline non-seizure state is [considered to be] different than [a] normal brain state without a seizure, ... this ... would raise a 112 issue as the specifics of establishing this baseline state is not recited in the method claim language." Final Act. 16. However, there is no rejection of claim 12 under 35 U.S.C. § 112 for us to review. 6 Appeal2014-008524 Application 12/432,268 Claims 32-34, 42, 44-46, 52, 64, 65, and 69 Independent claim 32 recites a system comprising a processor that adjusts a seizure detection algorithm by, in part, performing the same steps recited in method claim 12 that are discussed above. Appeal Br. 30 (Claims App.). For the reasons provided in connection with claim 12, we do not sustain the rejection of claim 32, and of claims 33, 34, 64, 65, and 69 depending from claim 32, as anticipated by Leyde. Independent claim 42 recites a system comprising means for adjusting a seizure detection algorithm by, in part, performing the same steps recited in method claim 12 that are discussed above. Appeal Br. 32 (Claims App.). For the reasons provided in connection with claim 12, we do not sustain the rejection of claim 42, and of claims 44--46 and 52 depending from claim 42, as anticipated by Leyde. B. Obviousness based on Leyde and one or more of Donoghue, Giftakis, Nathan, Greene, and Osorio The Examiner's additional consideration of dependent claims 18-21, 37-39, 47--49, 53-55, 58, 61-63, 66, 70, and 71 in light of Leyde in combination with one or more of Donoghue, Giftakis, Nathan, Greene, and Osorio, does not cure the deficiency of Leyde in connection with independent claims 12, 32, and 42 noted above. See Final Act. 10-16. Therefore, we do not sustain the various obviousness rejections of these dependent claims. 7 Appeal2014-008524 Application 12/432,268 DECISION The Examiner's decision to reject claims 12-14, 17-21, 32-34, 37- 39, 42, 44--49, 52-58, 61---66, and 69-71 is reversed. REVERSED 8 Copy with citationCopy as parenthetical citation