Ex Parte Bolea et alDownload PDFPatent Trial and Appeal BoardMay 30, 201712835984 (P.T.A.B. May. 30, 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. 12/835,984 07/14/2010 Stephen L. Bolea 104292-1305 1268 138270 7590 06/01/2017 FOT FY Rr T ARDNFR T T P EXAMINER 3000 K STREET N.W. HELLER, TAMMIE K SUITE 600 WASHINGTON, DC 20007-5109 ART UNIT PAPER NUMBER 3766 NOTIFICATION DATE DELIVERY MODE 06/01/2017 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): ipdocketing @ foley. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STEPHEN L. BOLEA, THOMAS B. HOEGH, BRUCE J. PERSSON, ROBERT E. ATKINSON, and SCOTT T. MAZAR Appeal 2016-003929 Application 12/835,9841 Technology Center 3700 Before DONALD E. ADAMS, RICHARD J. SMITH, and TIMOTHY G. MAJORS, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims 75—78, 86—90, 95—97, and 99-103 (Br. 4). Examiner entered rejection under 35 U.S.C. § 102(b). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellants identify the real party in interest as “Cyberonics, Inc.” (Br. 2). Appeal 2016-003929 Application 12/835,984 STATEMENT OF THE CASE Appellants disclose “devices[] and associated methods for treating sleeping disorders” (Spec. 12). Claim 86 is representative and reproduced below: 86. A device, comprising: a neurostimulator for generating an electrical stimulus signal; a stimulation lead connected to the neurostimulator, the stimulation lead having a nerve cuff electrode for delivering the electrical stimulus signal to a portion of a hypoglossal nerve; and a respiration sensing lead connected to the neurostimulator for sensing a bioimpedance signal, the respiration sensing lead having at least one bio-impedance electrode defining, at least in part, a bio-impedance vector on an anterior side of a thorax of a patient, wherein the delivery of the electrical stimulus signal is provided as a function of a sensed respiratory signal from the bio-impedance vector, and wherein electrical stimulus signal delivery is initiated before an onset of a future inspiratory phase and continued during the entire future inspiratory phase without identifying the onset of the future inspiratory phase. (Br. 13.) The claims stand rejected as follows: Claims 75—78, 86—90, 95—97, and 99-103 stand rejected under 35 U.S.C. § 102(b) as anticipated by Park.2 2 Park et al., US 2003/0153953 Al, published Aug. 14, 2003. 2 Appeal 2016-003929 Application 12/835,984 ISSUE Does the preponderance of evidence on this record support Examiner’s finding that Park teaches Appellants’ claimed invention? FACTUAL FINDINGS (FF) FF 1. We adopt Examiner’s findings concerning the scope and content of the prior art (Ans. 2—3 and 4—6; see Final Act. 2—3), and provide the following findings for reference purposes. FF 2. Park “relates to techniques for providing therapy to patients who suffer from sleep apnea” (Park 13; see generally Ans. 3). FF 3. Park’s Figure 10 is reproduced below: Park’s “FIG. 10 is a schematic flow chart that illustrates actions of the stimulation device when a pacing therapy fails to terminate sleep apnea, and a more extreme level of intervention is appropriate” (Park 139). 3 Appeal 2016-003929 Application 12/835,984 FF 4. Examiner finds that Park teaches every element of Appellants’ claimed invention (Ans. 2—3 and 4—6; see also Final Act. 2—3), including, with reference to Park’s Fig. 10, a device that “monitors the respiration signal 1006 to determine when the patient begins inspiration in each cycle of a series of respiratory cycles[,] tracks the timing of inspiration onset to predict the time of inspiration onset in subsequent cycles[, and] [w]hen monitoring indicates a reliable respiratory timing 1008, [the device] predicts the next inspiration onset time 1010 and anticipates the predicted inspiration onset time by a predetermined onset interval 1012” (Park 1149; see Ans. 5). FF 5. Park’s device “generates a series of neurostimulation pulses within a single respiratory cycle 1014 beginning the onset interval time prior to the predicted inspiration onset” and “delivers the neurostimulation pulses for a preset number of respiration cycles 1016,” wherein “[n]eurostimulation may be selected for consecutive cycles or with a predetermined number of respiration cycles between a respiration cycle with neurostimulation” (Park 1150; see Ans. 5—6). FF 6. Examiner finds that in Park’s device: respiration is monitored for a predetermined series of respiration cycles, this monitored respiration is used to predict a future inspiratory onset, stimulus delivery is initiated before the onset of this future inspiratory phase, and the stimulus is delivered for a preset number of respiratory cycles before cycling back to monitor respiration if the stimulation does not terminate the apnea. (Ans. 6.) 4 Appeal 2016-003929 Application 12/835,984 ANALYSIS With regard to Appellants’ claim 86, Examiner finds: Park discloses a device, comprising: a neurostimulator 810 for generating an electrical stimulus signal; a stimulation lead 812 connected to the neurostimulator, the stimulation lead having a nerve cuff electrode 814 for delivering the electrical stimulus signal to a portion of a hypoglossal nerve; and a respiration sensing lead 816 connected to the neurostimulator for sensing a bio-impedance signal, the respiration sensing lead having at least one bio-impedance electrode defining, at least in part, a bio-impedance vector on an anterior side of a thorax of a patient; wherein the delivery of the electrical stimulus signal is provided as a function of a sensed respiratory signal from the bio-impedance vector, and wherein electrical stimulus signal delivery is initiated before an onset of a future inspiratory phase and continued during the entire future inspiratory phase without identifying the onset of the future inspiratory phase (see Figures 8-10 and paragraphs [0042], [0044], [0092], [0143], [0144], and [0149]). (Ans. 3.) Appellants contend that “even if the timing of a future inspiration onset is predicted by Park, the actual timing of that future inspiration onset still must be identified so that it can be used to predict even future inspiration onsets” (Br. 10 (emphasis removed)). According to Appellants, “one of ordinary skill in the art would readily understand that the disclosed Park apparatus and method must continuously identify inspiratory onsets of past, current, and future respiratory cycles so as to reliably and continuously ‘predict the next inspiration onset time.’ (Para. [0149].)” (id. (emphasis removed)). Therefore, Appellants’ contend, “[c]lear error thus exists in the rejection because the rejection states that the Park method does not identity the onset of a future inspiratory phase when the text of Park and a figure of Park state the opposite” (id. (emphasis removed)). We are not persuaded. 5 Appeal 2016-003929 Application 12/835,984 Park’s device provides for “[njeurostimulation [that] may be selected for consecutive cycles or with a predetermined number of respiration cycles between a respiration cycle with neurostimulation” (FF 5; see generally Ans. 6). Notwithstanding Appellants’ contention to the contrary, Appellants’ “comprising” claim does not preclude an additional step of “cycling back to monitor respiration if the stimulation does not terminate the apnea” (FF 6; cf Br. 10). Therefore, we are not persuaded by Appellants’ contention that “one of ordinary skill in the art would readily understand that the disclosed Park apparatus and method must continuously identify inspiratory onsets of past, current, and future respiratory cycles so as to reliably and continuously ‘predict the next inspiration onset time.’ (Para. [0149].)” (Br. 10 (emphasis removed)). CONCLUSION OF LAW The preponderance of evidence on this record supports Examiner’s finding that Park teaches Appellants’ claimed invention. The rejection of claim 86 under 35 U.S.C. § 102(b) as being anticipated by Park is affirmed. Claims 75—78, 87—90, 95—97, and 99-103 are not separately argued and fall with claim 86. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 6 Copy with citationCopy as parenthetical citation