Ex Parte Rogowski et al

Patent Trial and Appeal BoardDec 7, 2012

11804720 (P.T.A.B. Dec. 7, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte ROBERTA L. ROGOWSKI, SUSAN E. DUBE, and PHILIP JOCHELSON __________ Appeal 2011-012031 Application 11/804,720 Technology Center 1600 __________ Before TONI R. SCHEINER, DONALD E. ADAMS, and MELANIE L. McCOLLUM, Administrative Patent Judges. McCOLLUM, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to methods for reducing early awakenings and for decreasing fragmented sleep in the 8th hour of a sleep period. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE Claims 1-16 and 18-23 are pending and on appeal (App. Br. 2). We will focus on claims 1, 9, and 23, the only independent claims on appeal, Appeal 2011-012031 Application 11/804,720 2 which are set forth in the Claims Appendix to the Appeal Brief (id. at 15- 16). Claim 1 is illustrative and reads as follows: 1. A method for reducing or preventing early awakenings in a patient in need thereof, comprising: identifying a patient having a sleep disorder in which, for a given 8 hour period of desired sleep, the patient experiences a sleep period that terminates during the final 60 minutes of said period; and providing to the patient doxepin or a pharmaceutically acceptable salt thereof in a dosage between about 0.5 and 6 mg that is effective to lengthen the sleep period. Claims 1-16 and 18-23 stand rejected under 35 U.S.C. § 103(a) as obvious Kavey 1 in view of Erman 2 (Ans. 4). The Examiner relies on Kavey for teaching “a method for treating transient, chronic, and non-chronic forms of insomnia comprising administration of doxepin, at a dosage ranging from 0.5 to 20 mg., and particularly exemplifies dosages of about 10 mg. or less; 5 mg.; or 2 mg” (id.). The Examiner finds that “Kavey teaches that doxepin is administered to treat maintenance insomnia and to allow the patient to maintain a normal sleep period” (id. at 4-5). The Examiner relies on Erman for teaching “that transient insomnia is associated with a sleep deficiency such as WASO [wake after sleep onset] . . . and that normal subjects sleep for an 8-hour period” (id. at 5). The Examiner also relies on Erman for teaching “a sleep deprivation study in which subjects were awakened after 7.5 hours” (id.). 1 Kavey, US 6,211,229 B1, Apr. 3, 2001. 2 Erman et al., Comparative efficacy of zolpidem and temazepam in transient insomnia, 16 HUMAN PSYCHOPHARMACOLOGY CLIN. EXP. 169-176 (2001). Appeal 2011-012031 Application 11/804,720 3 The Examiner concludes that, “as normal subjects are taught to sleep for an 8-hour period, it would have been prima facie [obvious] to one of ordinary skill in the art to associate sleep disorders as including sleep which terminates prior to the end of the eighth hour of sleep” (id.). The Examiner also concludes: [I]t would have been prima facie obvious for one of ordinary skill in the art, such as a medical practitioner, to first identify the patient population in need of treatment, prior to providing treatment. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to identify a patient that experiences a sleep period that terminates during the final 60 [minutes] of an 8-hour period of sleep, prior to administration of doxepin. (Id. at 8.) Appellants argue: Kavey does not discuss whether doxepin has any effect during the 8th hour of a sleep period. Treatment of maintenance insomnia, for example, could mean that a patient waking at hour 5 now sleeps into hour 6. Erman tested different drugs, having different mechanisms of action. Neither drug was known to have any 8th hour effect. In fact, Erman terminated his testing at 7.5 hours. Erman’s WASO and sleep efficiency data cover awakenings during the entire 7.5 hour period, so it is impossible to determine what, if any, effect they had during the 8th hour versus the 1st, 2nd, 3rd, etc. Neither reference identifies a patient with a sleep period that terminates during the final 60 minutes of an 8 hour sleep period. Thus, even a combination of the references does not result in the claimed invention. (App. Br. 7.) We conclude that Appellants have the better position. Claims 1 and 23 both require “identifying a patient having a sleep disorder in which, for a given 8 hour period of desired sleep, the patient Appeal 2011-012031 Application 11/804,720 4 experiences a sleep period that terminates during the final 60 minutes of said period” and providing doxepin or its salt to that patient. Similarly, claim 9 requires “identifying a patient suffering from fragmented sleep during the 8th hour of a sleep period” and providing doxepin or its salt to that patient. As noted by the Examiner, Kavey discloses the use of doxepin “for the treatment of . . . maintenance insomnia” (Kavey, col. 2, ll. 39-63). Kavey also discloses that “the point of [its] invention is to induce and maintain normal sleep without exposing the patient to residual effect of medication” (id. at col. 3, ll. 51-54). However, the Examiner acknowledges that “Kavey does not explicitly teach . . . treating patients who experience sleep termination during the final 60 . . . minutes of the 8-hour sleep period” (Ans. 5). Nor does the Examiner find that Kavey discloses treating patients suffering from fragmented sleep during the 8th hour of a sleep period. Erman is directed to a study comparing the hypnotic effects of zolpidem, temazepam, and placebo in healthy adults (Erman, Abstract). Erman discloses that “[s]ubjects were normal sleepers as defined by the following criteria: a customary total sleep time of 7-8 h . . .” (id. at p. 171, col. 1). Thus, Erman includes those who sleep for 7 hours within its definition of “normal sleepers.” We do not agree with the Examiner that Erman suggests that doxepin would be expected to be effective during the 8th hour of a sleep period. Thus, we agree with Appellants that the Examiner has not set forth a prima facie case of obviousness as to claims 1, 9, and 23 or as to claims 2-8, 10-16, Appeal 2011-012031 Application 11/804,720 5 and 18-22, which depend from claims 1 or 9. We therefore reverse the obviousness rejection. REVERSED alw