Ex Parte Helton et al

Patent Trial and Appeal BoardApr 5, 2016

13207274 (P.T.A.B. Apr. 5, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/207,274 08/10/2011 94694 7590 LOZA & LOZA LLP Michael Fedrick, Esq. 305 North Second Ave., #127 Upland, CA 91786 04/07/2016 FIRST NAMED INVENTOR David HELTON 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. CELGENE-1002CON 5619 EXAMINER KIM, JENNIFER M ART UNIT PAPER NUMBER 1628 NOTIFICATION DATE DELIVERY MODE 04/07/2016 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): mike-pto@lozaip.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DAVID HELTON, DAVID FICK, and ERNEST PF ADENHAUER 1 Appeal2013-009222 Application 13/207,274 Technology Center 1600 Before MELANIE L. McCOLLUM, ULRIKE W. JENKS, and JACQUELINE T. HARLOW, Administrative Patent Judges. McCOLLUM, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134 involving claims to a method for treating a stress disorder. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. Â§ 6(b). We affirm. STATEMENT OF THE CASE Claims 1-3, 5-7, 9, 10, 12-15, and 17-23 are on appeal (Br. 4). Claims 1 and 13 are representative and read as follows (emphasis added): 1. A method of treating post-traumatic stress disorder and acute stress disorder, comprising the step of administering to a patient in need thereof a 1 Appellants identify the real parties in interest as Abraxis Bioscience, Inc. and, its parent company, Celgene Corporation (Br. 2). Appeal2013-009222 Application 13/207,274 therapeutic dose of between 1.0 mg/kg and 10 mg/kg a pharmaceutical composition comprising a compound having the following formula: where: (a) A2 and A3 are C or N; (b) R3 is hydrogen, alkyl, aralky, heteroaralkyl, alkenyl, aralkenyl, heteroaralkenyl, aryl, heteroaryl, or does not exist when A3 is N; ( c) R6 is hydrogen, alkyl, aralkyl, heteroaralkyl, aryl or heteroaryl; ( d) R6â€¢ is hydrogen unless R6 is alkyl, in which case R6â€¢ is hydrogen or the same alkyl as R6; (e) Lis a straight chain alkyl group of the formula-(CH2)m-, and wherein mis an integer between 2 and 4; and (f) B has the following formula: where: (i) R2 is hydrogen or halo; (ii) R3 is hydrogen, halo, or perfluoroalkyl; and (iv) Riis hydrogen or halo; and pharmaceutically acceptable salts and esters thereof. 13. The method of claim 1, wherein the composition of claim 1 comprises a compound selected from the group consisting of: 1-{2-[ 4-(3-Chlorophenyl)piperazin-1-yl]ethyl }-1,5,6, 7-tetrahydroindol- 4-one; 1-{ 4-[ 4-( 4-Fluorophenyl)piperazin-1-yl]butyl }-1,5,6,7-tetrahydroindol- 4-one; 2 Appeal2013-009222 Application 13/207,274 1-{ 4-[ 4-( 4-Bromophenyl)piperazin-1-yl]butyl }-1,5,6,7-tetrahydroindol- 4-one; 1-{ 4-[ 4-(3-Trifluoromethylphenyl)piperazin-1-yl]butyl }-1,5,6,7-tetra- hydroindol-4-one; 1-{2-[ 4-(3-Trifluoromethylphenyl)piperazin-1-yl]ethyl }-1,5,6,7-tetra- hydroindol-4-one; 1-{3-[ 4-(3-Chlorophenyl)piperazin-1-yl]propyl }-1,5,6,7-tetrahydroindol- 4-one; 1-{3-[ 4-(3-Trifluoromethylphenyl)piperazin-1-yl]propyl }-1,5,6,7-tetra- hydroindol-4-one; 1-{ 4-[ 4-(3, 4-dichlorophenyl)piperazin-1-yl] butyl }-1, 5, 6, 7-tetrahydroindol- 4-one; 1-{ 4-[ 4-(3-Chloro-4-fluorophenyl)piperazin-1-yl]butyl }-1,5,6,7-tetra- hydroindol-4-one; 1-{ 4-[ 4-(2,4-Dichlorophenyl)piperazin-1-yl]butyl }-1,5,6,7-tetrahydroindol- 4-one; and 1-{3-[ 4-(3,4-Dichlorophenyl)piperazin-1-yl]propyl }-1,5,6,7-tetrahydroindol- 4-one. Claims 1-3, 5-7, 9, 10, 12-15, and 17-23 stand rejected under 35 U.S.C. Â§ 103(a) as obvious over Helton et al. (WO 2005/030148 A2, Apr. 7, 2005) in view of Fick et al. (US 6,770,638 B2, Aug. 3, 2004) (Ans. 3). The Examiner relies on Helton for teaching "pharmaceutical compositions comprising tetrahydroindolones derivatives in which the tetrahydroindolone moiety is covalently linked to a substituted arylpiperazine moiety" and "compositions useful in treating anti-psychotic disorders" (Final Act. 5). The Examiner finds: Generally, the composite compounds consist of two moieties, THI moiety and arylpiperazine moiety in which a tetrahydroindolone comprises a moiety THI linked through a linker L to a moiety R3, where R3 is an arylpiperazinyl moiety. The compound provides anti-psychotic actively by interaction with GABA, serotonin and dopamine receptors . . . . The 3 Appeal2013-009222 Application 13/207,274 compos1t10n is useful to treat psychiatric and neurological diseases including post-traumatic stress syndrome. (Id.) The Examiner also finds that Heaton teaches "exemplary dosages of the compounds range from O.OOlmg/kg to 60mg/kg" (id. at 4 (emphasis omitted)). In addition, the Examiner finds that Helton teaches a "specific species of the formula set forth in claims 1 and 13 ( ... compound 27)" (id. at 8). The Examiner relies on Fick for teaching that "compounds set forth in claims 13, 19 and 23 are useful as anti-psychotic activity by interaction with GABA, serotonin and dopamine receptors"; "that these compounds are useful for treatment of psychiatric and neurological disease without cognitive impairment"; and "that the exemplary dosages of the compounds range from O.OOOlmg/kg to 60mg/kg" (id. (emphasis omitted)). The Examiner concludes that it would have been obvious "to employ the Fick et al' s compounds such as compounds set forth in claims 13, 19 and 23 for the treatment of post-traumatic stress disorder" and that "to optimize the therapeutic dosages within the general range well known by Helton et al and Fick et al involve only routine skill in the art" (id. at 8-9). ANALYSIS Helton discloses tetrahydroindolone derivatives, such as 1-{ 4-[ 4-(3,4-Dichlorophenyl)piperazin-l-yl]butyl }-1,5,6,7-tetrahydroindol- 4-one (Helton 4: 1to7: 10 & 8: 25 (compound 27)). In addition, Helton discloses that "[t]hese compounds can be used as anti-psychotic compounds and administered to treat psychiatric disorders such as ... post traumatic stress syndrome" (id. at 15: 24--26). Helton also discloses that "[ e ]xemplary dosages ... for these compounds range from 0.0001 mg/kg to 60 mg/kg" (id. 4 Appeal2013-009222 Application 13/207,274 at 21: 17-18). In view of these disclosures, we conclude that the Examiner has set forth a prima facie case that the methods of claims 1 and 13 would have been obvious. Appellants argue: [T]he present application includes experimental data, in particular in Examples 3 and 4, which demonstrates the efficacy of the presently claimed compounds (those having a halo substituent at the R4 position) in the treatment of PTSD. The data shows that at the particular dosages recited in independent claim 1 (between 1.0 mg/kg and 10 mg/kg), such compounds effectively treat PTSD. Moreover, these compounds do not cause unwanted side effects at such dosages. (Br. 10.) However, we agree with the Examiner that Appellants have not provided sufficient evidence that the claimed invention provides unexpectedly superior results as compared to the prior art (Ans. 4). CONCLUSION The evidence supports the Examiner's conclusion that Helton and Fick suggest the methods of claims 1 and 13. We, therefore, affirm the obviousness rejection of claims 1and13. Claims 2, 3, 5-7, 9, 10, 12, 14, 15, 17, 18, and 20-22 have not been argued separately and therefore fall with claim 1. In addition, claims 19 and 23 are argued and fall with claim 13. 37 C.F.R. Â§ 41.37(c)(l)(iv). TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). AFFIRMED 5