Ex Parte Johnson et alDownload PDFPatent Trial and Appeal BoardJul 15, 201613355217 (P.T.A.B. Jul. 15, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/355,217 01/20/2012 82893 7590 07118/2016 BFF/Durect Corporation Bozicevic, Field & Francis Durect Corporation - Corporate Headquarters 10260 Bubb Road Cupertino, CA 95014-4166 FIRST NAMED INVENTOR Randolph Johnson 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. DURE-007CON7 5164 EXAMINER GHALI, ISIS AD ART UNIT PAPER NUMBER 1611 MAILDATE DELIVERY MODE 07/18/2016 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte RANDOLPH JOHNSON and FELIX THEEUWES Appeal2014-005994 Application 13/355,217 Technology Center 1600 Before JEFFREY N. FRED MAN, RICHARD J. SMITH, and TA WEN CHANG, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal 1 under 35 U.S.C. § 134 involving claims to a method of inducing systemic analgesia in a subject. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm. 1 Appellants identify the Real Party in Interest as Durect Corporation (see App. Br. 3). Appeal2014-005994 Application 13/355,217 Statement of the Case Background "Opiates have been widely used for anesthesia as well for the treatment of pain, especially where the pain is very severe. In addition to these natural opiates, many synthetic opioids have since been synthesized including methadone, fentanyl and congeners of fentanyl such as sufentanil" (Spec. i-f 8). "Despite its therapeutic advantages and vast experience with the drug, many pain management experts believe that morphine and other opioids are under-prescribed for patients who require long-term pain therapy" (Spec. i-f 8). The Claims Claims 28--44 are on appeal. Independent claim 28 is representative and reads as follows: 28. A method of inducing systemic analgesia in a subject, the method comprising systemically administering sufentanil to the subject at a therapeutically effective rate to provide substantially continuous delivery of sufentanil at from about 0.01 µg/hr to about 200 µg/hr over a period of at least 24 hours, wherein said administering induces systemic analgesia in the subject, and wherein said sufentanil is formulated in a sufentanil formulation comprising at least 50 mg/ml sufentanil. The Issue The Examiner rejected claims 28--44 under 35 U.S.C. § 103(a) as obvious over Wappler, 2 White, 3 Nelson, 4 and Wagemans 5 (Ans. 2-7). 2 Wappler et al., Analgesia and sedation with sufentanil in intensive care medicine, 33 Anasthesiollnesivmed Notfallmed 2 Appeal2014-005994 Application 13/355,217 The Examiner finds that Wappler teaches that "administration of sufentanil is suitable for intensive care patients for systemic sedation and analgesia ... Sufentanil continuous infusion was provided in a dose between 0.075 to 2.5 µg/kg/hr with median of 0.6 µg/kg/hr" (Ans. 3). The Examiner finds that "[ f]or the average person weighing 60 kg, the dose disclosed by Wappler that induces systemic analgesia will ranges from 4.5 µg/hr to 150 µg/hr" (Ans. 3). The Examiner acknowledges that Wappler does not teach "the formulation comprising 50 mg/ml sufentanil" or delivery for "3-10 days" (Ans. 3--4). The Examiner finds that White teaches the "dose can be calculated by using plasma concentrations and pharmacokinetic variables" and that Nelson teaches a "dose sufficient for long period administration, e.g. six month dose, can be calculated ifthe daily dose is known" (Ans. 4). The Examiner finds that W agemans teaches "analgesic is administered by implanted infusion pump for months or years" (Ans. 4). The Examiner finds that the ordinary artisan "would have readily optimized effective dosages and concurrent administration regimens of sufentanil as determined by good medical practice and the clinical condition of the individual patient" (Ans. 10-11 ). Schmerzther 8-26 (1998) (We rely on the English translation with pages numbered sequentially from page 1 ). 3 White et al., Clinical Uses of Intravenous Anesthetic and Analgesic Infusions, 68 Anesth. Analg. 161-171 (1989). 4 Nelson et al., US 5,980,927, issued Nov. 9, 1999. 5 Wagemans et al., Long-Term Spinal Opioid Therapy in Terminally Ill Cancer Pain Patients, 2 The Oncologist 70-75 (1997). 3 Appeal2014-005994 Application 13/355,217 The issue with respect to this rejection is: Does the evidence of record support the Examiner's conclusion that the Wappler, White, Nelson, and Wagemans render the claims obvious? Findings of Fact 1. Wappler teaches that "Sufentanil offers an alternative to the traditional drug strategies for analgesia and sedation .... sufentanil has the highest analgesic potency of the opioids, it offers a better hemodynamic stability than other opioids, and has a shorter distribution and elimination half-life than the frequently used fentanyl" (Wappler 1 ). 2. Wappler teaches that "[p ]atients with controlled respiration conditions needed a sufentanil delivery of 0.075 to 2.5 µg/kg/h with a median of 0.6 µg/kg/h" (Wappler 5). 3. Table 4 of White is reproduced, in part, below: fll!nta~yl {SubUmaz.t-ll) $U~~'1iJ (SufCopy with citationCopy as parenthetical citation