Ex Parte CoulterDownload PDFPatent Trial and Appeal BoardJan 4, 201713441780 (P.T.A.B. Jan. 4, 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. 13/441,780 04/06/2012 Ivan Coulter 8365-83989-02 2041 24197 7590 01/06/2017 KLARQUIST SPARKMAN, LLP 121 SW SALMON STREET SUITE 1600 PORTLAND, OR 97204 EXAMINER MAEWALL, SNIGDHA ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 01/06/2017 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): tanya.harding@klarquist.com docketing @klarquist.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte IVAN COULTER Appeal 2015-004451 Application 13/441,780 Technology Center 1600 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35U.S.C. § 134 involving claims to a method for treating celiac disease. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Statement of the Case Background “The invention provides an oral composition comprising minicapsules wherein the minicapsules comprise one or more therapeutic or prophylactic substances in a liquid, semi-solid, or solid core, the minicapsules having release profiles to release the substance in an active form at one or more sites along the gastrointestinal tract” (Spec. 11:22—26). 1 Appellant identifies the Real Party in Interest as Sigmoid Pharma Limited (see App. Br. 1). Appeal 2015-004451 Application 13/441,780 The Claims Claims 1—32 are on appeal. Claim 1 is representative and reads as follows: 1. A method for treating [cjeliac disease, wherein the method is selected from A or B: A. a method comprising administering to a patient in need thereof a composition comprising minicapsules, wherein the minicapsules comprise a steroid in a liquid, semi-solid or solid core, the minicapsules having release profiles to release the steroid in an active form at one or more sites along the gastrointestinal tract, the one or more sites comprising the proximal small intestine beginning at the duodenum and ending at the ileum; and B. a method comprising administering budesonide to a patient in need thereof in a solubilised drug delivery format. The Issue The Examiner rejected claims 1—32 under 35 U.S.C. § 103(a) as obvious over Severin,2 Moodley,3 Patel,4 and Sandbom5 (Ans. 2—6). The Examiner finds Severin teaches “therapy with budesonide (a steroid) in patients with refractory sprue and with celiac disease” and that “[ijnadvertent but also deliberate gluten intake is clearly the commonest cause of apparent unresponsiveness to GFD [gluten free diet] in celiac disease patients” (Ans. 3). 2 Severin Daum et al., Therapy with Budesonide in Patients with Refractory Sprue, 73 Digestion 60—68 (2006) (“Severin”). 3 Moodley et al., US 2006/0018965 Al, published Jan. 26, 2006 (“Moodley”). 4 Patel et al., US 2003/0180352 Al, published Sept. 25, 2003 (“Patel”). 5 Sandbom et al., US 6,166,044, issued Dec. 26, 2000 (“Sandbom”). 2 Appeal 2015-004451 Application 13/441,780 The Examiner acknowledges that Severin “does not disclose use of minicapsules as claimed for delivery of budesonide [for] treating celiac disease” and does “not teach use of steroid in liquid, semi-solid or solid core of minicapsules as claimed in claim 1” (Ans. 3). The Examiner finds Moodley suggests use of a “microcapsule to deliver the drugs such as steroids for the gastrointestinal treatment of disease” (Ans. 3). The Examiner finds Moodley teaches the “dosage form can be further coated to release the microcapsules at predetermined rates and/or site of gastrointestinal sites” (Ans. 4). The Examiner finds Patel teaches “targeted delivery of active ingredients to duodenum, ileum and colon” (Ans. 5). The Examiner finds Sandbom teaches “ileum delivery of nicotine and budesonide wherein the active ingredient is coated with Eudragit L30D” (Ans. 5). The Examiner concludes that it would have been obvious to have utilized the microcapsule of Moodley et al. and administer such microcapsule comprising budesonide to patients with celiac disease with refractory sprue. One of ordinary skill would have been motivated to do so because Moodley teaches . . . the microcapsules can be coated to release the pharmaceutically active ingredient at specific gastrointestinal sites and for pre-determined rates and suggests use of steroids in such microcapsules to be used in delivering the agent to [a] predetermined site in gastrointestinal region. (Ans. 4—5). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that the prior art renders claim 1 obvious? 3 Appeal 2015-004451 Application 13/441,780 Findings of Fact 1. Severin teaches: Refractory sprue (RS) is a malabsorption syndrome defined by persisting villous atrophy, usually with an increase in intraepithdial lymphocytes (IELs) in the small bowel in spite of a strict gluten-free diet (GFD)[.] Persisting vinous atrophy has been found in 5—8% of patients with celiac disease (CD), including patients with persistent gluten intake. (Severin 60, col. 2; citations omitted). 2. Severin teaches “[ljocally acting budesonide could replace systemic corticosteroid therapy and reduce toxicity in patients with RS” (Severin, abstract). 3. Severin teaches a “clinical long-term response (>12 months) was documented in 7 patients (4 of 6 with underlying CD, 3 of 3 without CD) for 21 months (range 14—60) under 6 mg of budesonide” (Severin 62, col. 2). 4. Table 1 of Severin is reproduced, in part, below (Severin 63): Chai^dariftks of paSctiR * , S Kd j ? P< til' Po n't AIE RSI R$ 3 .RSI RS s’ ES l\ RS li CD4 * R S11 rfCL c. 9 3 P mS-ok >a j Copy with citationCopy as parenthetical citation