10381889 (B.P.A.I. Mar. 9, 2011)

Ex Parte Fabo

Board of Patent Appeals and InterferencesMar 9, 2011

10381889 (B.P.A.I. Mar. 9, 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. 10/381,889 07/14/2003 Tomas Fabo 13302.0004U1 9521 23859 7590 03/09/2011 Ballard Spahr LLP SUITE 1000 999 PEACHTREE STREET ATLANTA, GA 30309-3915 EXAMINER EBRAHIM, NABILA G ART UNIT PAPER NUMBER 1618 MAIL DATE DELIVERY MODE 03/09/2011 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 TOMAS FABO __________ Appeal 2010-012537 Application 10/381,889 Technology Center 1600 __________ Before ERIC GRIMES, LORA M. GREEN, and STEPHEN WALSH, Administrative Patent Judges. GREEN, Administrative Patent Judge. DECISION ON APPEAL1 This is a decision on appeal under 35 U.S.C. § 134 from the Examiner’s rejection of claims 34-38. We have jurisdiction under 35 U.S.C. § 6(b). 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2010-012537 Application 10/381,889 2 STATEMENT OF THE CASE Claim 34 is the only independent claim on appeal, and reads as follows: 34. A wound dressing comprising: a dry skin self-adhesive composition comprising a mixture of: i) a substance for lowering the pH of water upon contact with skin moisture when said substance is applied to a wound dressing adhered to skin, wherein said substance is selected from the group consisting of alpha- hydroxyacids and their salts, beta-hydroxyacids and their salts, phosphate buffer, an ampholytic substance, and mixtures thereof, ii) a hydrophilic polymer that swells upon contact with skin moisture to increase the area of contact of said adhesive with skin moisture and wherein said hydrophilic polymer is selected from the group consisting of xanthan gum, pectin, and synthetic hydrogels, and iii) an adhesive selected from the group consisting of a solvent-based acrylate adhesive, water emulsion-based acrylate adhesive, a tacky hot-melt adhesive, a silicone adhesive and mixtures thereof, wherein said dry skin self adhesive does not comprise water and does not need to comprise water in order to be self-adhesive; and a supporting material wherein said supporting material is coated with said composition. The following grounds of rejection are before us for review: I. Claims 34 and 38 stand rejected under 35 U.S.C. § 102(a or e) as being anticipated by Repka.2 II. Claims 34-38 stand rejected under 35 U.S.C. § 103(a) as being rendered obvious by the combination of Repka and Ewall.3 We reverse. 2 Repka, US 6,375,936 B1, issued Apr. 23, 2002. 3 Ewall, US 4,977,892, issued Dec. 18, 1990. Appeal 2010-012537 Application 10/381,889 3 ISSUE Has the Examiner established by a preponderance of the evidence that Repka teaches a mixture containing an adhesive as required by the wound dressing of independent claim 34? FINDINGS OF FACT FF1 According to the Specification, the “present invention relates to a skin-friendly adhesive and to a wound dressing which is provided with such an adhesive” (Spec. 1). FF2 The Specification teaches with respect to the adhesive that the “invention primarily relates to those self-adhering adhesives whose tackiness is not dependent on a particular water content, such as many self-adhesive hydrogels which contain large proportions of water” (id. at 6). FF3 The Specification further defines “self-adhering” as “meaning an adhesive which attaches the dressing/plaster to normal, non-wet skin by means of adhesion and that the dressing does not fall off due to its own weight” (id. at 7). FF4 The Examiner’s statement of the anticipation rejection may be found at pages 3-4 of the Answer. FF5 The Examiner finds that Repka teaches the wound dressing of claim 34 (Ans. 3). FF6 The Examiner finds that Repka teaches that a suitable adhesive would be a silicone adhesive (id. (citing Repka, col. 8, ll. 43-44)). FF7 Citing Example 5 of Repka, the Examiner finds that Repka teaches the same mixture as required by claim 34 (Ans. 3). Appeal 2010-012537 Application 10/381,889 4 FF8 According to the Examiner, the polycarbophil disclosed by Repka “is a polyacrylate which is within the scope of the ‘solvent-based acrylate system’ recited in instant claim 34” (id. at 6). FF9 Repka teaches “a bioadhesive extruded film that is an effective, feasible, and convenient topical or intra-cavity drug delivery system for applying and delivering controlled dosages of therapeutic agents onto the skin or into the body cavities” (Repka, col. 2, ll. 62-66). FF10 Repka teaches that the film may comprise a “water soluble or water- swellable polymer derived from acrylic acid or a pharmaceutically acceptable salt thereof, such as . . . Polycarbophil” (id. at col. 3, ll. 29-34). FF11 Repka teaches further that the “film formulations of the invention will adhere to mucosal surfaces (oral, rectal, vaginal, etc.) and/or skin surfaces when wet” (id. at col. 3, ll. 45-47). FF12 Repka teaches that the films comprise at least one bioadhesive extruded film layer, as well as other layers, such as a drug-matrix layer and backing layer, but that “[i]n some cases the single or multi-layer system may require a suitable adhesive layer (silicones, etc.)” (id. at col. 8, ll. 34-44). FF13 Example 4 is drawn to a monolayer topical wound care patch adhesive film, which “may contain an adhesive layer overlaying and extending 1/8 to 2 inches beyond the patch” (id. at col. 11. l. 59-col. 12, l. 12). Appeal 2010-012537 Application 10/381,889 5 FF14 Repka teaches that the monolayer wound care patch of Example 4 has the following ingredients: (Id.) FF15 Example 5 of Repka is “another illustration of a single layer topical wound care patch” (id. at col. 12, ll. 15-31). It has the following ingredients: PRINCIPLES OF LAW To anticipate, every element and limitation of the claimed invention must be found in a single prior art reference, arranged as in the claim. See Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001). ANALYSIS Appellant argues that Repka “discloses a silicone adhesive as one layer of a multilayer film, not as part of the bioadhesive composition” (App. Br. 7). Appellant further asserts that Example 5 of Repka does not disclose Appeal 2010-012537 Application 10/381,889 6 a mixture comprising “an adhesive selected from the group consisting of a solvent-based acrylate adhesive, water emulsion-based acrylate adhesive, a tacky hot-melt adhesive, a silicone adhesive and mixtures thereof” as required by claim 34 (Claim 34). We agree with Appellant. Repka teaches that “[i]n some cases the single or multi-layer system may require a suitable adhesive layer (silicones, etc.)” (FF12), and provides an Example wherein an adhesive is added as a separate layer (FFs13 and 14). Thus, we find that even though Repka discusses a single-layer system, if a silicone adhesive is added, it is added as a separate layer and not admixed with the other two components of the mixture required instant claim 34. As to the Examiner’s finding that the Polycarbophil disclosed by Repka is a polyacrylate which is within the scope of the solvent-based acrylate system recited in instant claim 34 (FF8), Repka teaches that Polycarbophil is a water soluble or water-swellable polymer (FF10), and the Examiner has not provided any evidence or scientific reasoning that Polycarbophil would meet the properties of the adhesive require by claim 34, other than the fact it is derived from acrylic acid or a pharmaceutically acceptable salt thereof. CONCLUSION OF LAW We conclude that the Examiner has not established by a preponderance of the evidence that Repka teaches a mixture containing an adhesive as required by the wound dressing of independent claim 34. We Appeal 2010-012537 Application 10/381,889 7 are thus compelled to reverse the rejection of claims 34 and 38 under 35 U.S.C. § 102(a or e) as being anticipated by Repka. In addition, as the Examiner did not cite Ewall to remedy the deficiencies of Repka, we reverse the rejection of claims 34-38 under 35 U.S.C. § 103(a) as being rendered obvious by the combination of Repka and Ewall. REVERSED alw BALLARD SPAHR LLP SUITE 1000 999 PEACHTREE STREET ATLANTA, GA 30309-3915