Ex Parte HessDownload PDFPatent Trial and Appeal BoardJan 25, 201713886697 (P.T.A.B. Jan. 25, 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. 13/886,697 05/03/2013 Michael F. Hess P0022823.USV2 1059 27581 7590 Medtronic, Inc. (CRDM) 710 MEDTRONIC PARKWAY NE MS: LC340 Legal Patents MINNEAPOLIS, MN 55432-9924 EXAMINER HENSON, DEVIN B ART UNIT PAPER NUMBER 3736 NOTIFICATION DATE DELIVERY MODE 01/27/2017 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): medtronic_crdm_docketing @ c ardinal-ip .com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MEDTRONIC, INC. and MICHAEL F. HESS1 Appeal 2015-003377 Application 13/886,697 Technology Center 3700 Before DONALD E. ADAMS, ERIC B. GRIMES, and SHERIDAN K. SNEDDEN, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134 involving claims relating to measuring impedance in a patient, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE “Transthoracic impedance measurements give a good indication of the fluid status of patients. . . . Fluid accumulation can occur, for example, when the body’s mechanisms for preventing fluid accumulation are affected 1 Appellants identify the Real Party in Interest as Medtronic, Inc. (Br. 2.) Appeal 2015-003377 Application 13/886,697 by disease, such as heart failure.” (Spec. 1:15—26.) The Specification states that “devices which track impedance changes in a patient over time . . . use[] data collected between 12pm and 5pm each day. This standardization is intended to eliminate postural variability that could confound the trending algorithm.” (Id. at 2:9-13.) Claims 1—16 are on appeal. Claims 1 and 9 are the independent claims and read as follows (emphasis added): 1. A non-transitory computer-readable medium programmed with instructions for performing a method in an implantable medical device, the medium comprising instructions for causing a programmable processor to: measure impedances of a patient in a supine position; measure impedances of the patient in an upright position; and generate a diurnal delta corresponding to impedance differences between the supine and upright positions. 9. A non-transitory computer-readable medium programmed with instructions for performing a method in an implantable medical device, the medium comprising instructions for causing a programmable processor to: measure impedances of a patient in a supine position; measure impedances of the patient in an upright position; and generate a diurnal delta impedance value corresponding to impedance differences between the supine and upright positions. DISCUSSION The Examiner has rejected claims 1,2, 5—10, and 13—16 under 35 U.S.C. § 102(b) as anticipated by Hatlestsad.2 (Ans. 2.) The Examiner has rejected claims 3,4, 11, and 12 under 35 U.S.C. § 103(a) as obvious based 2 U.S. 7,226,422 B2, patented June 5, 2007. 2 Appeal 2015-003377 Application 13/886,697 on Hatlestsad and Siejko.3 (Ans. 5.) The same issue is dispositive for both rejections. The Examiner finds that Hatlestsad discloses an implantable medical device that includes a processor programmed to carry out the functions recited in claims 1 and 9, including “generat[ing] a diurnal delta (see col. 5, lines 38-51 and col. 6, line 62-col. 7, line 2) corresponding to impedance differences between the supine and upright positions (see Figures 3, 4, and 6 and col. 1, lines 54-62, and col. 5, line 38-col. 6, line 28).” (Ans. 3.) Appellant argues that [t]he diurnal deltas of Hatlestad [sic] are not differences (deltas) in impedance as required by the claims. They are differences (changes) in respiration patterns. Yes, the respiration patterns are derived from the measured impedances, but there is never any comparison of measured impedances or any calculation of a difference between measured impedances. (Br. 4.) We agree with Appellant that Hatlestsad does not disclose generating the “diurnal delta” values recited in the claims, as that term would be read in light of the Specification. The Specification states that impedance measurements can be used as an indicator of heart failure (Spec. 1:13—26), but the presently available devices only use impedance data collected between noon and 5:00 pm “to eliminate postural variability that could confound the trending algorithm.” {Id. at 2:9—13.) The Specification states that the invention include [s] an algorithm for processing [impedance] measurements to determine a diurnal delta, e.g., a parallel 3 US 2006/0161070 Al, published July 20, 2006. 3 Appeal 2015-003377 Application 13/886,697 comparison or cross checking of the measurements taken during the night against the measurements taken during the daytime. The diurnal delta may then provide a leading indicator of edema that may be evident only when a patient is in the supine position, which results in superior predictive value for detecting heart failure decompensation. (Id. at 11:23-29.) The Specification also refers to Figure 6 as showing a “delta 706 or difference over time between daytime 702 and nighttime 704 measurements.” (Id. at 12:10—16.4) Figure 6 shows a graph of impedance values over time, where a solid line (702) indicates daytime values, a darker solid line (704) indicates lower nighttime values, and a series of double headed arrows (706) indicates the degree of difference between the two sets of values. Based on these descriptions, we conclude that the broadest reasonable interpretation of “diurnal delta” in light of the Specification is the difference in impedance values measured during the day (when the patient is upright) and those measured during the night (when the patient is lying down). Hatlestsad discloses “detection of congestion by assessing the patient’s respiratory distress . . . based on a comparison of respiration pattern before and after the patient becomes recumbent.” (Hatlestsad 1:45—49.) “[Congestion is indicative of heart failure.” (Id. at 1:19.) “One manner of detecting the respiratory patterns is through monitoring trans-thoracic impedance variation . . . during each individual inhale and exhale cycle.” 4 The Specification actually cites Figure 7, but Figure 7 is a flow chart that does not include the graph discussed on page 12 of the Specification. From the context, it is clear that Figure 6 is intended. 4 Appeal 2015-003377 Application 13/886,697 (Id. at 3:17—20.) Hatlestsad states that its Figure 4 “shows two illustrative hypothetical respiration pattem[s]. . . . The rapid and shallow breathing of the recumbent respiration pattern indicates a patient suffering from orthopnea, or paroxysmal nocturnal dyspnea (‘PND’) that eventually occurs upon lying down. The presence of orthopnea or PND such as shown in FIG. 4 is known to be a sign of congestion.” (Id. at 5:40-53.) Thus, Hatlestsad discloses that impedance measurements can be used to track respiration patterns, and a change in respiration pattern when a patient is lying down can be a sign of heart failure. However, Hatlestsad does not describe tracking impedance itself and determining the difference in impedance measurements taken during the day versus those taken at night; i.e., a “diurnal delta,” as that term would be interpreted based on the Specification. Hatlestsad therefore does not anticipate claims 1 and 9, or dependent claims 2, 5—8, 10, and 13—16. The rejection of claims 3,4, 11, and 12 as obvious based on Hatlestsad and Siejko relies on the Examiner’s finding that Hatlestsad anticipates the independent claims. We therefore reverse the rejection under 35U.S.C. § 103(a) as well. SUMMARY We reverse both of the rejections on appeal. REVERSED 5 Copy with citationCopy as parenthetical citation