12887250 (P.T.A.B. Feb. 7, 2017)

Ex Parte Chang et al

Patent Trial and Appeal BoardFeb 7, 2017

12887250 (P.T.A.B. Feb. 7, 2017)

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. 12/887,250 09/21/2010 Yunik Chang 50796-018003 2121 21559 7590 CLARK & ELBING LLP 101 FEDERAL STREET BOSTON, MA 02110 02/09/2017 EXAMINER JAVANMARD, SAHAR ART UNIT PAPER NUMBER 1627 NOTIFICATION DATE DELIVERY MODE 02/09/2017 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): patentadministrator@clarkelbing.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte YUNIK CHANG, ROBERT LATHROP, ERWIN BOHM, IRENE GANDER-MEISTERERNST, REGINA GREGER, JOHANNA HOLLDACK, and ULRICH MOEBIUS1 Appeal 2015-007995 Application 12/887,250 Technology Center 1600 Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and RACHEL H. TOWNSEND, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a pharmaceutical composition, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE “Papilloma viruses (HPV) are DNA viruses which infect the epithelial cells of mammals and thereby induce uncontrolled cell growth. . . [and] cause genital warts.” (Spec. 2.) “Herpes simplex viruses (HSV) are DNA 1 Appellants identify the Real Party in Interest as MediGene AG. (Appeal Br. 2.) Appeal 2015-007995 Application 12/887,250 viruses from the alpha subfamily Herpetoviridae .... [and] penetrate, as a nucleocapsid, into the nerve endings and, using the axonal flow, reach the appurtenant ganglia.” (Spec. 3.) Appellants’ invention relates to a pharmaceutical composition containing two different types of active ingredients that are capable of treating viral skin diseases caused by papilloma virus and herpes virus. (Spec. 14, 17—19.) Claims 1—19 and 26—28 are on appeal.2 Claim 1 is representative and reads as follows: 1. A pharmaceutical composition comprising: (i) a compound having the formula A-B (I), wherein A is a radical having the formula O IS and wherein B is a radical having the formula -O-R2 (III), and wherein Ri is, independent of each other, an unbranched or branched, saturated, singly or multiply unsaturated, optionally substituted C13-C21 alkyl, alkylene, or alkynyl radical, and R2 is, independent of each other, an unbranched or branched Ci-Cg alkyl, alkylene, or alkynyl radical; and (ii) a mixture of catechols comprising 2—20% (w/w) of (-)-epicatechol, 2—20% (w/w) of (-)-epicatechol gallate, (w/w) of (-)-epigallocatechol, 40- 75% (w/w) of (-)-epigallocatechol gallate, 0.05—5% (w/w) of (+)- gallocatechol, and 0.5—20% (w/w) of (-)-gallocatechol gallate; and wherein the pharmaceutical comprises at least 5—50% (w/w) of the compound of formula (I). 2 Claims 20-25 are also pending, but stand withdrawn from consideration. 2 Appeal 2015-007995 Application 12/887,250 (Appeal Br. 8.) The following ground of rejection by the Examiner is before us on review: Claims 1—19 and 26—28 under 35 U.S.C. § 103(a) as unpatentable over Keith,3 Cheng,4 and Femandez-Pol.5 DISCUSSION The Examiner finds that Keith teaches a topical composition of isopropyl myristate and a pharmaceutically active compound, 4-(lower alkyl)-2,6-(bis-tert-butyl)-phenol, for the treatment of herpes. (Final Action 4.) The Examiner finds that the isopropyl myristate is present in amounts of 70 to 95%, but can be present in a lipstick formulation in an amount from 5 to 20% to protect against recurrent herpes infection. (Ans. 6.) The Examiner finds that Cheng teaches a topical composition for treating genital warts that contains tea catechins, such as epicatechin, epicatechin gallate, epigallocatechin gallate, gallocatechin that can be used singly or in combination. (Final Action 4.) The Examiner further finds that Cheng teaches (-)-epigallocatechin gallate at 54.8% is particularly desirable. (Id.) The Examiner finds that Femandez-Pol teaches a topical ointment that is effective in treating sexually transmitted diseases including herpes and genital warts. (Final Action 5.) The Examiner concludes from the 3 Keith, EP 0087161 A2, published Aug. 31, 1983. 4 Cheng et al., EP 0842660 Al, published May 20, 1998. 5 Femandez-Pol, US 6,127,393, issued Oct. 3, 2000. 3 Appeal 2015-007995 Application 12/887,250 foregoing, i.e., that herpes and genital warts are sexually transmitted diseases that can have common treatments, that it would have been obvious to combine the Keith and Cheng compositions together to treat both genital warts and herpes. (Id.) We disagree with the Examiner’s conclusion that the claimed composition would have been obvious. It is true, as the Examiner contends (Final Action 5), that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.” In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980). However, based on the facts of this case, we conclude that treating sexually transmitted diseases is too broad a purpose. As Appellants note, “[wjhile both herpes and genital warts may be sexually transmitted, they are different diseases caused by different infectious agents.” (Appeal Br. 6.) Moreover, the lesions from herpesvirus can manifest in areas that genital warts do not. Furthermore, following a primary infection, herpesvirus can be reactivated by irritation such as radiation. (Spec. 3; Keith 2.) That Femandez-Pol teaches metal chelating materials can treat both genital warts and herpes does not establish that a composition with different chemical structures and different chemistries, such as the active ingredients present in Keith or Cheng, can treat both genital warts and herpes at the concentrations claimed. Claim 1 requires from 5 to 50% isopropyl myristate in combination with a mixture of catechols. As Appellants note, the lipstick formulation of Keith containing from 5 to 20% isopropyl myristate, is for preventing recurrent herpes lesions (Keith 2), i.e., preventing reactivation by 4 Appeal 2015-007995 Application 12/887,250 radiation trauma, that manifest on the lips, not treating them. (Reply Br. 4.) Keith discloses treating herpes blisters, sores, or lesions with a composition that includes from about 70 to 95% isopropyl myristate. (Keith 2.) Thus, one of ordinary skill in the art would not understand that 5 to 20% isopropyl myristate would be able to treat herpes that manifest in the genitalia, where genital warts are also manifest. For the foregoing reasons, we do not agree with the Examiner that one of ordinary skill in the art would have found it obvious to combine the composition of Cheng for treating genital warts with the composition of Keith that includes 5 to 20% isopropyl myristate to also treat herpes. SUMMARY We reverse the rejection of claims 1—19 and 26—28 under 35 U.S.C. § 103(a) as unpatentable over Keith, Cheng, and Femandez-Pol. REVERSED 5