Ex Parte Dressman et al

Patent Trial and Appeal BoardFeb 13, 2019

14511669 (P.T.A.B. Feb. 13, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 14/511,669 10/10/2014 Marlene Michelle Dressman 23550 7590 02/15/2019 HOFFMAN WARNICK LLC 540 Broadway 4th Floor ALBANY, NY 12207 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. VAND-0126-USl 1434 EXAMINER PODGORSKI, DANIEL MICHAEL ART UNIT PAPER NUMBER 1628 NOTIFICATION DATE DELIVERY MODE 02/15/2019 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): PTOCommunications@hoffmanwarnick.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MARLENE MICHELLE DRESSMAN, MIHEAL H. POLYMEROPOULOS, and PAOLO BAROLDI 1 Appeal 2018-002176 Application 14/511,669 Technology Center 1600 Before ERICA A. FRANKLIN, JOHN G. NEW, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal2 under 35 U.S.C. Â§ 134 from the Examiner's rejections of claims directed to treating sleep disorders as obvious and for 1 Appellants identify the Real Party in Interest as Vanda Pharmaceuticals, Inc. Br. 1. 2 We have considered and herein refer to the Specification of Oct. 10, 2014 ("Spec."); Final Office Action of Feb. 22, 2017 ("Final Act."); Appeal Brief of July 24, 2017 ("Br."); Examiner's Answer of Oct. 25, 2017 ("Ans."); and Reply Brief ("Reply Br.") of Dec. 26, 2017. Appeal 2018-00217 6 Application 14/511,669 non-statutory obviousness-type double patenting. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We REVERSE. STATEMENT OF THE CASE The invention relates to a method for treating circadian rhythm or sleeps disorders using tasimelteon. Abstract. The Specification describes a method whereby tasimelteon is administered under fasting conditions. Spec. 1. Claims 1-3, 5, 6, 9-11, and 13-24 are on appeal. Claim 1 representative and reads as follows: 1. A method of treating a human patient suffering from a circadian rhythm disorder or a sleep disorder that comprises orally administering to the patient an effective dose of tasimelteon without food, wherein the effective dose is 20 mg/ d. The claims stand rejected as follows: Claims 1-3, 5, 9-11, and 13-24 have been rejected under 35 U.S.C. Â§ 103(a) as unpatentable over Rajaratnam3 in view of Guidance. 4 3 Rajaratnam & Polymeropoulos., Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised control multicentre trials, 373 The Lancet 482-93 (2009) ("Rajaratnam"). 4 Ctr. Drug Eval. & Res., Food & Drug Admin., Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies, 1-9 (2002) ("Guidance"). 2 Appeal 2018-00217 6 Application 14/511,669 Claims 6 and 14 have been rejected under 35 U.S.C. Â§ 103(a) as unpatentable over Rajaratnam in view of Guidance in further view of Zisapel. 5 Claims 1-3, 5, 6, 9-11, 13, and 14 have been rejected fornon- statutory obviousness-type double patenting over claim 1 ofUSSN 14/510,321 6 in view of Guidance. Claims 1-3, 5, 6, 9-11, 13, and 14 have been rejected for non- statutory obviousness-type double patenting over claims 67, 70, 71, 75, 78, 81, 84, and 87 ofUSSN 14/374,2577 in view of Guidance. Claims 1-3, 5, 6, 9-11, 13, 14, and 15-24 have been rejected for non- statutory obviousness-type double patenting over claim 1 of Dressman III8 in view of Guidance. DISCUSSION Issue In each of the rejections on appeal, the Examiner relies on the teachings of Guidance to support the conclusion of obviousness or 5 N. Zisapel, Circadian Rhythm Sleep Disorders: Pathophysiology and Potential Approaches to Management, 15 CNS Drugs (4) 311-328 (2001) ("Zisapel"). 6 USSN 14/510,321 issued on Aug. 15, 2017 as US 9,730,910 B2, and lists Dressman et al. as inventors. ("Dressman I"). 7 USSN 14/374,257 issued on Jan. 24, 2017 as US 9,549,913 B2, and lists Dressman et al. as inventors. ("Dressman II"). 8 Dressman et al., US 8,785,492 B2, issued July 22, 2014 ("Dressman III"). We shall refer to Dressman I, II, and III collectively as "the Dressman patents." 3 Appeal 2018-00217 6 Application 14/511,669 obviousness-type double patenting. Final Act. 3--4, 11-12, and 14--15. The issue therefore before us is whether the teachings of Guidance support the Examiner's conclusion that the subject matter of the claims would have been obvious or that the rejected claims are not patently distinct from the Dressman patents. The Examiner finds that Rajaratnam teaches the administration of tasimelteon to treat transient insomnia in circadian rhythm sleep disorders. Final Act. 3. The Examiner also finds that Rajaratnam teaches administering tasimelteon orally in doses of 10, 20, 50, or 100 mg. Id. With respect to the obviousness-type double patenting rejections, the Examiner finds that each of the Dressman patents claim methods for treating patients with a circadian rhythm sleep disorder using a 20 mg dose of tasimelteon. Final Act. 11 and 13. The Examiner finds that Guidance teaches that food can affect the bioavailability of drugs resulting in clinically significant consequences. Final Act. 3, 11, and 13. The Examiner finds that Guidance teaches testing drug formulations under both fasting and fed conditions to determine what effect these states have on bioavailability. Id. The Examiner concludes It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to have administered tasimelteon under fasted conditions (i.e. without food; instant claims 2, 8, 10). One would have been motivated to do so as Guidance teaches that food changes the bioavailability of a drug and has clinically significant consequences, such as altered bioavailability, drug permeability, and systematic availability, and that the magnitude and direction of such effects are impossible to 4 Appeal 2018-00217 6 Application 14/511,669 determine without administration of a drug under fasted or fed conditions. Therefore one of ordinary skill in the art would have had a reasonable expectation of determining the optimal food effects of administration conditions of tasimelteon to treat circadian rhythm sleep disorders by administration of the drug under fasted conditions (i.e. without food). Final Act. 4, 13, and 15. Appellants contend that one skilled in the art reading Guidance would not have been led to administer tasimelteon under fasting conditions. Appeal Br. 3. Appellants argue that Guidance does not teach or suggest that fasting would have any effect on the bioavailability of tasimelteon. Id. Appellants contend that without the study conducted by Appellants, one skilled in the art could not predict what effect, if any, fasting would have on the bioavailability of tasimelteon. Appeal Br. 4. Principles of Law [T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case ofunpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant. After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). The test of obviousness is "whether the teachings of the prior art, taken as a whole, would have made obvious the claimed invention." In re Gorman, 933 F.2d 982, 986 (Fed. Cir. 1991). 5 Appeal 2018-00217 6 Application 14/511,669 "It is well-established that before a conclusion of obviousness may be made based on a combination of references, there must have been a reason, suggestion, or motivation to lead an inventor to combine those references." Pro-Mold & Tool Co. v. Great Lakes Plastics Inc., 75 F.3d 1568, 1573, (Fed. Cir. 1996). "[T]he law of obviousness-type double patenting looks to the law of obviousness generally. As ... explained in Amgen, '[t]his part of the obviousness-type double patenting analysis is analogous to an obviousness analysis under 35 U.S.C. Â§ 103."' AbbVie Inc. v. The Mathilda and Terrence Kennedy Inst. of Rheumatology Trust, 764 F.3d 1366, 1378-79 (Fed. Cir. 2014) (Emphasis in the original). Analysis We have considered the arguments advanced by the Examiner and Appellants and find that Appellants have the better positon. While Guidance suggests administration of a drug while fasting, that teaching is part of a test design to see if food intake has an effect on bioavailability and bioequivalence. Guidance 4--5. The Guidance explains that such test should be carried out in "healthy volunteers drawn from the general population." Id. at 5. The Guidance does not teach or suggest administering the drug while fasting to treat a condition or to patients in need of such treatment. Rather it teaches that the test described in the Guidance should be used to determine if food affects bioavailability and bioequivalence. Id. at 1. Indeed, the results of the test are not measured with respect to any treatment effectiveness. Instead, the Guidance teaches that fluid samples, usually 6 Appeal 2018-00217 6 Application 14/511,669 plasma, should be collected "to permit characterization of the complete shape of the plasma concentration-time profile" for the drug. Id. at 6. Thus, we agree with Appellants that one skilled in the art would not be motivated to combine the teachings of Rajaratnam and the Guidance to administer tasimelteon after fasting to treat a patient suffering from a circadian rhythm or a sleeping disorder, as required by the claims. Appeal Br. 4. We note also that the Examiner has not asserted, nor do we see, that Zisapel supplies such a motivation either. Conclusion of Law We conclude that the Examiner has not established that the subject matter of the claims would have been obvious over Rajaratnam combined with Guidance alone or in further view of Zisapel. We also conclude that the Examiner has not established that the present claims are not patently distinct from the claims of the Dressman patents for the same reasons we have discussed regarding the deficiency in the Examiner's obviousness rejection. SUMMARY We reverse the rejections under 35 U.S.C. Â§ I03(a). We reverse the rejections for non-statutory obviousness-type double patenting. REVERSED 7