Ex Parte DavidaiDownload PDFPatent Trial and Appeal BoardJun 18, 201311454720 (P.T.A.B. Jun. 18, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte GIORA DAVIDAI __________ Appeal 2012-001350 Application 11/454,720 Technology Center 1600 __________ Before DONALD E. ADAMS, LORA M. GREEN, and MELANIE L. McCOLLUM, Administrative Patent Judges. GREEN, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal 1 under 35 U.S.C. § 134 from the Examiner‟s rejection of claims 1, 6-9, 11, and 23. 2 We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 The Real Party in Interest is Boehringer Ingelheim International GmbH (App. Br. 1). 2 Claims 3-5 and 12-22 are also pending, but stand withdrawn from consideration (App. Br. 1). Appeal 2012-001350 Application 11/454,720 2 STATEMENT OF THE CASE The “invention relates to a method for the prophylaxis of vascular headaches which do not originate from hypertension, especially migraine” (Spec. 1). The Specification further defines the term “„vascular headaches‟” as including “any kind of vascular headaches, like migraine, cluster headache, post-traumatic headache, etc. not due to hypertension (i.e. not originated from hypertension)” (id. at 4). Claim 1 is the only independent claim on appeal, and reads as follows: 1. A method for prophylaxis of vascular headache which does not originate from hypertension, the method comprising co-administering a therapeutically effective amount of telmisartan and a therapeutically effective amount of at least one other drug suitable for the prophylaxis of migraine to a subject in need of such a treatment by oral, rectal, nasal or inhalative administration. The following ground of rejection is before us for review: Claims 1, 6-9, 11, and 23 stand rejected under 35 U.S.C. § 103(a) as being rendered obvious by the combination of Etminan 3 and Silberstein 4 (Ans. 4-5). ANALYSIS The Examiner finds that Etminan teaches “the prevention of headaches and migraines using angiotensin II receptor antagonists (pg. 644, right col. paragraph 1) such as telmisartan (Table)” (Ans. 5). The Examiner 3 Etminan et al., Efficacy of Angiotensin II Recptor Antagonists in Preventing Headache: A Systematic Overview and Meta-analysis, 112 EXCERPTA MEDICA 642-646 (2002). 4 Silberstein et al., US 5,977,145, issued Nov. 2, 1999. Appeal 2012-001350 Application 11/454,720 3 also finds that not all of the patients that were being treated for headache in the studies reviewed by Etminan were being treated for hypertension, and also finds that Etminan does not teach that headaches are the result of hypertension (id. (citing Etminan, 643, col. 2, ¶ 1)). According to the Examiner, “[t]he two disorders were simply both coexistent in the patients” (id.). The Examiner finds that Etminan fails to teach the co-administration of triptan (id.). The Examiner relies on Silberstein for teaching “a method of treating migraines by administering a triptan, such as sumatriptan (col. 1, lines 8- 19)” (id.). The Examiner further finds that “it is obvious to one of ordinary skill in the art to administer the active agents orally, since this is the conventional administration method for treating migraines, such as for aspirin or ibuprofen” (id.). The Examiner concludes that it would have been obvious to co- administer sumatriptan, as taught by Silberstein, with the telmisartan, as taught by Etminan, as they are both used in the treatment of migraines (id. at 6). Appellant argues that Silberstein teaches treating migraine episodes by intravenous or intramuscular injection of droperidol, but does not teach or suggest oral, rectal, nasal, or inhalative administration, as required by the claimed process (App. Br. 4). Specifically, Appellant asserts that “Silberstein specifically requires intravenous or intramuscular injection and there is absolutely no supportable reason given for why one of ordinary skill in the art would modify this requirement of Silberstein” (id. at 7). Appeal 2012-001350 Application 11/454,720 4 The Examiner responds that only the background section of Silberstein was used to demonstrate that it was known to use sumatriptan in the treatment of headaches (Ans. 10-11). According to the Examiner, the claimed route of administration was taught by Etminan, and the use of intravenous or intramuscular injection as taught by Silberstein was limited to droperidol (id. at 11). We conclude that the preponderance of the evidence of record does not support the Examiner‟s finding that the ordinary artisan would have administered sumatriptan by oral, rectal, nasal or inhalative administration. The portion of Silberstein relied upon by the Examiner teaches (emphasis added): The prevalence of migraine is said to be approximately 6% of the male population and 18% of the female population. Treatment for many patients having the occasional migraine usually involves simple analgesics, non-steroidal anti- inflammatory agents, or specific agents such as ergotamines or triptans. Approximately 10% of migraine sufferers have three or more attacks per month and warrant prophylactic treatment. Preventative agents such as beta -blockers, tricyclic antidepressants and divalproex sodium can reduce but not eliminate migraine attacks in some patents. Thus, there remains a need for migraine specific medications such as sumatriptan. In the remaining population of migraine sufferers, and in those with intolerable side-effects from available drugs, there is a lack of conventional pharmaceutical preparations that exhibit therapeutic effect, without severe side-effects. (Silberstein, col. 1, ll. 8-23.) Appeal 2012-001350 Application 11/454,720 5 Thus, while Silberstein teaches that sumatriptan is useful for the treatment of migraines, it does not teach how the agent is administered. Silberstein goes on to teach: In accordance with the present invention droperidol is administered, either intravenously (“I. V.”) or intramuscularly (“I.M.”), to a patient during a migraine attack, in an amount that is effective to treat symptoms of migraine. Droperidol may be used without pretreatment or in conjunction with other migraine therapies. (Id. at col. 1, ll. 40-45.) Thus, although Silberstein does not teach that sumatriptan should be administered either intravenously or intramuscularly, it is evidence that some drugs useful in the treatment of migraine are restricted to those types of administration. Thus, while it may be routine to administer certain drugs by oral, rectal, nasal or inhalative administration, the Examiner has not provided any evidence that it was known at the time of invention that sumatriptan could be administered by the claimed methods and retain its effectiveness in the treatment of migraine. Moreover, we also agree with Appellant that while Etminan concludes that angiotensin II receptor agonists may reduce the occurrence of headaches, Etminan also specifically teaches that the mechanism was unclear and the type of headache for which the occurrence of headache was reduced was not known (App. Br. 2-3). Thus, we agree with Appellant that Etminan cannot be read as a generic teaching that telmisartan may be a useful prophylaxis for any type of headache, and thus does not provide a reasonable expectation of success that telmisartan “would be effective for Appeal 2012-001350 Application 11/454,720 6 prophylaxis of the particular nature of a vascular headache which does not originate from hypertension, such as a migraine headache” (id. at 5). Specifically, Etminan is drawn to a meta-analysis of the efficacy of angiotensin II receptor antagonists in preventing headache (Etminan, Abstract). In performing the analysis, the authors searched various databases using terms such as headache, headache disorders, cluster headaches, tension headaches, and migraine to find those studies that measured headache (id. at 642, col. 2). The studies chosen for the meta-analysis involved the use of an angiotensin II receptor antagonist in the treatment of mild-to-moderate hypertension (id. at 643, col. 1). The authors noted that there was a 31% reduction in the risk of headache associated with angiotensin II receptor antagonists, but as most of the patients were being treated for hypertension, “the headaches that were prevented with angiotensin II receptor antagonists could have been related to etiologies other than migraine” (id. at 643, col. 2). The authors thus noted that the meta-analysis had several limitations, such it was not known what type of headache occurred in the studies, or how the headache was measured (id. at 644, col. 1). That is important as “the pathology of the headache would likely predict the type of pharmacologic intervention needed for prophylaxis” (id.). The authors thus conclude that the results of the analysis “indicate that angiotensin II receptor antagonists reduce the frequency of headache, and that other cardiovascular drugs are effective in migraine prophylaxis” (id. at 644, col. 2 (emphasis added)). Therefore, contrary to the finding of the Examiner, Etminan does not teach “the prevention of headaches and migraines using angiotensin II Appeal 2012-001350 Application 11/454,720 7 receptor antagonists … such as telmisartan” (Ans. 5). Rather, while the reference posits that angiotensin II receptor antagonists may reduce the risk of vascular headache which does not originate from hypertension, such as migraine, it specifically notes that the study could not determine the origin of the headaches that were reduced by the administration of angiotensin II receptor antagonists. Given all of the undefined variables in the studies used in the meta-analysis of Etminan, the reference does not provide a reasonable expectation that the risk of vascular headache which does not originate from hypertension such as migraine could be reduced using angiotensin II receptor antagonists. Thus, the preponderance of the evidence of record does not support the Examiner‟s conclusion of obviousness, and we reverse the rejection. REVERSED dm Copy with citationCopy as parenthetical citation