11841789 (B.P.A.I. May. 25, 2011)

Ex Parte Gale

Board of Patent Appeals and InterferencesMay 25, 2011

11841789 (B.P.A.I. May. 25, 2011)

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. 11/841,789 08/20/2007 Robert M. Gale AR02896USCNT2 2503 84486 7590 05/25/2011 Samuel E.Webb STOEL ROVES LLP 600 University Street Suite 3600 Seattle, WA 98101 EXAMINER GULLEDGE, BRIAN M ART UNIT PAPER NUMBER 1612 MAIL DATE DELIVERY MODE 05/25/2011 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte ROBERT M. GALE __________ Appeal 2010-009513 Application 11/841,789 Technology Center 1600 __________ Before DONALD E. ADAMS, MELANIE L. McCOLLUM, and STEPHEN WALSH, Administrative Patent Judges. Opinion for the Board filed by Administrative Patent Judge McCOLLUM. Opinion Concurring filed by Administrative Patent Judge ADAMS. McCOLLUM, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a transdermal nicotine administration device. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2010-009513 Application 11/841,789 2 STATEMENT OF THE CASE Claims 1, 3, 6, 7, 10, and 13 are pending and on appeal (App. Br. 6). Claim 1 is representative and reads as follows: 1. A device for transdermal administration of nicotine, comprising: a polymeric backing layer comprising a material selected from the group consisting of PET/EVA laminates, HDPE/EAA/nylon/EAA multilaminate and a film comprising a graft copolymer formed from 73-77% acrylonitrile and from 23-27% methyl acrylate copolymerized in the presence of 8-10 parts by weight of butadiene/acrylonitrile copolymers containing 70% by weight of polymer units derived from butadiene, a drug reservoir layer containing nicotine carried by the backing layer, and an adhesive for maintaining the device on the skin, wherein the device provides delivery of nicotine for a period of 18-24 hours and, as applied to the skin, exhibits an Opacity Index of less than 48.6% to permit the skin to which the device is applied to be visible through the device. Claims 1, 3, 6, 7, 10, and 13 stand rejected under 35 U.S.C. § 103(a) as obvious over Drug patches 1 in view of Sumiko 2 (Ans. 3). The Examiner concludes that it would have been obvious to prepare a transdermal delivery patch with a backing to deliver nicotine as taught by the article „Drug patches...‟, and use the polymeric backing layer (the laminate of polyethylene terephthalate/ethylene-vinyl acetate copolymer) as taught by Sumiko et al. in order to take advantage of the desirable properties of flexibility and prevent vaporization of the drug from the device. (Id. at 4.) 1 Drug patches catch on, CHEMBYTES E-ZINE (1997). 2 Sumiko et al., JP 07-165563, Jun. 27, 1995. Appeal 2010-009513 Application 11/841,789 3 ISSUE Does the preponderance of evidence support the Examiner‟s conclusion that it would have been obvious to combine Drug patches with Sumiko to form a transdermal nicotine administration device that provides delivery of nicotine for a period of 18-24 hours and, as applied to the skin, exhibits an Opacity Index of less that 48.6% to permit the skin to which the device is applied to be visible through the device? ANALYSIS There is evidence on this record indicating that it was known in the art that the concentration of nicotine decreases significantly as a result of exposure to as little as 1 hour of UV radiation (Eatough 3 685). It was also known in the art that one way to protect nicotine from UV degradation was to include an opaque backing material in the transdermal device (Ebert, 4 col. 7, ll. 63-65). Given this knowledge in the art, we agree with Appellant that the Examiner has not adequately explained why one of ordinary skill in the art would have selected Sumiko‟s polyethylene terephthalate/ethylene- vinyl acetate copolymer backing material in order to form a transdermal nicotine device exhibiting an Opacity Index of less than 48.6% to permit the skin to be visible through the device with a reasonable expectation that the resulting device would provide delivery of nicotine for a period of 18-24 hours. 3 Delbert J. Eatough et al., Chemical Composition of Environmental Tobacco Smoke. 1. Gas-Phase Acids and Bases, 23 ENVIRON. SCI. TECHNOL. 679-687 (1989). 4 Ebert et al., US 5,626,866, May 6, 1997. Appeal 2010-009513 Application 11/841,789 4 In particular, it is not clear to us that Wang 5 “demonstrates that one of ordinary skill in the art would have expected a poly(ethylene terephthalate)- containing film [to] absorb ultraviolet radiation” (Ans. 8), and thereby protect the nicotine from degradation. On the contrary, Wang teaches that poly(ethylene terephthalate) is itself subject to UV-degradation (Wang, Abstract), which if anything makes us question whether poly(ethylene terephthalate) would be a good choice to protect nicotine from UV- degradation during the 18-24 hour delivery period. CONCLUSION The preponderance of evidence fails to support the Examiner‟s conclusion that it would have been obvious to combine Drug patches with Sumiko to form a transdermal nicotine administration device that provides delivery of nicotine for a period of 18-24 hours and, as applied to the skin, exhibits an Opacity Index of less that 48.6% to permit the skin to which the device is applied to be visible through the device. We therefore reverse the obviousness rejection. REVERSED 5 Wei Wang et al., Surface Nature of UV Deterioration in Properties of Solid Poly(ethylene terephthalate), 67 J. APPLIED POLYMER SCI. 705-714 (1998). Appeal 2010-009513 Application 11/841,789 5 ADAMS, Administrative Patent Judge, concurring. I agree with my colleagues that the preponderance of evidence fails to support the Examiner‟s conclusion of obviousness. Therefore, I concur in the result. alw