Ex Parte RAADDownload PDFPatent Trial and Appeal BoardJan 26, 201711560300 (P.T.A.B. Jan. 26, 2017) Copy Citation 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. 11/560,300 11/15/2006 ISSAM RAAD UTSC:950US 5538 108197 7590 01/30/2017 Parker Highlander PLLC 1120 South Capital of Texas Highway Bldg. 1, Suite 200 Austin, TX 78746 EXAMINER BOWMAN, ANDREW J ART UNIT PAPER NUMBER 1717 NOTIFICATION DATE DELIVERY MODE 01/30/2017 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): docket @ phiplaw .com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte IS SAM RAAD Appeal 2015-001317 Application 11/560,300 Technology Center 1700 Before TERRY J. OWENS, MARK NAGUMO, and BRIAN D. RANGE, Administrative Patent Judges. OWENS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE The Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’ rejection of claims 2—6, 16, 33—36, 38, 39, 41, 42, 46-49, 51, 52, 58—61 and 68—74. We have jurisdiction under 35 U.S.C. § 6(b). The Invention The Appellant claims a method for coating or impregnating a non-organic surface1 with an antimicrobial agent. Claim 16 is illustrative: 16. A method for coating or impregnating a non-organic surface with an antimicrobial agent, comprising: 1 The Appellant defines “non-organic surface” as “a superficial or external aspect of any object other than a living organism” (Spec. 100012). Appeal 2015-001317 Application 11/560,300 a) contacting the surface with an [sic] composition comprising an antimicrobial agent, comprising chlorhexidine, gentian violet and a solvent; and b) heating the surface at a temperature that is at least 50°C for at least 8 hours, wherein at least some of the solvent that was contacted with the surface is removed, and wherein the antimicrobial agent coats or impregnates the surface. The References Darouiche US 5,624,704 Apr. 29, 1997 Fox EP 0 328 421 A2 Aug. 16, 1989 Raad WO 02/082907 A1 Oct. 24,2002 The Rejections Claims 2-6, 16, 33-36, 38, 39, 41, 42, 46-49, 51, 52, 58-61 and 68- 74 stand rejected under 35 U.S.C. § 103 over Raad in view of Darouiche and Fox.2 OPINION We affirm the rejection. The Appellant argues the claims in two groups: 1) claims 2—6, 16, 33— 36, 41, 42, 46-49, 51, 52, 58—61 and 68—74, and 2) claims 38 and 39 (App. Br. 3—7). We therefore limit our discussion to one claim in each group, i.e., claims 16 and 38.3 The other claim or claims in each group stand or fall with the claim we address. See 37 C.F.R. § 41.37(c)(l)(iv) (2012). 2 Claims 38 and 39 depend from canceled dependent claim 37, and claims 71—74 depend from canceled dependent claim 65. 3 On April 4, 2011 the Appellant changed claim 37’s dependency from claim 36 to claim 16 then, on August 15, 2013, canceled claim 37 but, apparently inadvertently, did not amend its dependent claim 3 8 to depend from claim 16. For purposes of this appeal we consider claim 38 to depend from claim 16. 2 Appeal 2015-001317 Application 11/560,300 Claim 16 Raad coats and impregnates a non-organic surface, which can be the surface of a medical implant, by contacting the surface with an antimicrobial agent composition comprising chlorhexidine, gentian violet and a solvent, and drying the composition to remove the solvent (abstract; p. 1,11. 12—19; p. 3,11. 14—15, 31-33; p. 4,11. 9-14, 2A-30; p. 5,11. 22-24; p. 8,11. 19-20, 28-31; p. 13,11. 1-17). Darouiche impregnates a non-metallic medical implant with an antimicrobial agent (which can be chlorhexidine) by dissolving the antimicrobial agent in an organic solvent to form an antimicrobial solution, adding a penetrating agent to the solution, preferably adding to the solution an alkalizing agent to enhance the reactivity of the material of the implant, heating the solution to about 30 to 70 -C to increase the antimicrobial agent’s adherence to the implant material, applying the solution to at least a portion of the implant such that the antimicrobial agent permeates the material of the implant, removing the impregnated implant from the solution, and allowing the solution to dry (col. 3,11. 24-48, 61—65; col. 4, 11. 53—58; col. 5,11. 16—17).4 In an example, catheters are dipped in an antimicrobial solution for 1 hour at 45 -C, removed from the solution, and dried for at least 8 hours, preferably overnight (col. 8,11. 28-32). Fox coats a medical device with a combination of a silver salt and chlorhexidine or its salts (abstract) to “impart antimicrobial activity to the medical device through a sustained and controlled activity rate over an 4 Darouiche is incorporated by reference into the Appellant’s Specification (100035). 3 Appeal 2015-001317 Application 11/560,300 appreciable period of time, without hampering the biocompatibility of the surface and other intended functions of the device” (p. 2,11. 37—39). “The coated medical device can be dried at room temperature to remove solvent or with the aid of a slightly elevated temperature over an appropriate time period” (p. 12,11. 22—23). The elevated temperature must be “below that which inactivates the antimicrobial agent” (p. 12,11. 5—6). In Example 6 a silver sulfadiazine/chlorhexidine acetate coating is air dried for about one minute and then dried in an oven at 40 °C for 24 hours (p. 17,11. 29-30). Establishing a prima facie case of obviousness requires showing that one of ordinary skill in the art would have had both an apparent reason or suggestion to modify the prior art and predictability or a reasonable expectation of success in doing so. See KSR, 550 U.S. at 418; In re Vaeck, 947 F.2d 488, 493 (Fed. Cir. 1991). Darouiche would have motivated one of ordinary skill in the art to dry Raad’s chlorhexidine/gentian violet/solvent antimicrobial agent composition by heating it preferably overnight at about 30-70 -C to enhance the adhesion of the chlorhexidine/gentian violet to the medical device. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Darouiche’s disclosure that the heating to about 30—70 -C enhances the adherence of chlorhexidine to the medical device (abstract; col. 5,11. 16—17) would have indicated to such a person that Raad’s gentian violet, due to being ionically or covalently chemically bonded to the chlorhexidine (p. 3,11. 14—17, 31—33; p. 4,11. 9-14), would undergo enhanced adherence to the medical device surface along with the chlorhexidine. Darouiche’s temperature range of about 30—70 -C which 4 Appeal 2015-001317 Application 11/560,300 overlaps the Appellant’s range of at least 50 -C would have rendered prima facie obvious, to one of ordinary skill in the art, temperatures within the overlap. See In re Geisler, 116 F.3d 1465, 1469-70 (Fed. Cir. 1997); In re Boesch, 617 F.2d 272, 276 (CCPA 1980); In re Malagari, 499 F.2d 1297, 1303 (CCPA 1974). That conclusion of prima facie obviousness is supported by Fox’s disclosure that drying can be carried out at any temperature “below that which inactivates the antimicrobial agent” (p. 12, 11. 5—6) and Fox’s indication that overnight (24 hours) heating at an elevated temperature (40 -C) within Darouiche’s temperature range (about 30 to 70 -C) is effective for treating a substrate which has been impregnated with an infection-resistant agent/organic solvent solution (Example 6). The Appellant asserts that “the longest time of treatment that is taught by Darouiche is 120 minutes” (App. Br. 4). That is the length of time the implant is dipped in the antimicrobial composition, not the antimicrobial composition-impregnated implant’s drying time, which preferably is overnight (col. 3,11. 48—52; col. 8,11. 33- 35). The Appellant asserts that “the highest temperature taught in the Darouiche examples is 45- C” (App. Br. 4). Darouiche is not limited to its examples. See In re Fracalossi, 681 F.2d 792, 794 n.l (CCPA 1982); In re Mills, 470 F.2d 649, 651 (CCPA 1972). Instead, all disclosures therein must be evaluated for what they would have fairly suggested to one of ordinary skill in the art. See In re Boe, 355 F.2d 961, 965 (CCPA 1966). Darouiche’s disclosed heating 5 Appeal 2015-001317 Application 11/560,300 temperature range wherein the adherence of the antimicrobial agent to the implant material is enhanced is about 30 to 70 -C (col. 3,11. 38^44). The Appellant asserts that the Appellant’s Example 2 shows that overnight heating of catheters at 60 -C has a dramatic effect on the catheter’s antimicrobial efficacy (App. Br. 5), and the Appellant “direct[s] the Examiner’s attention to Figures 5—8 and the accompanying text in Example 1, which demonstrates convincingly that the heat treatment of claim 16 provides a substantially improved coated catheter in terms of bacterial adherence (Fig. 5) and zones of inhibition (Figs. 6-7)” (App. Br. 6). Those assertions do not establish that those benefits would not be achieved by carrying out Darouiche’s overnight heating within the disclosed 30 to 70 °C range at which the adherence of the antimicrobial agent to the implant material is enhanced (col. 3,11. 38-44; col. 8,11. 33—35). Claim 38 Claim 38 requires that “the surface is heated for about 12 hours to about 96 hours.” The Appellant asserts that “even greater antimicrobial action is seen when heated for longer periods of time (claims 38 and 39)” (Reply Br. 3). Darouiche’s overnight heating (col. 8,11. 33—35) is within the Appellant’s claim 38’s required heating period. The Appellant asserts that heating for 1 day or 3 days shows a dramatic microbial killing ability improvement compared to no heating (App. Br. 6—7). That assertion does not establish that carrying out Darouiche’s overnight drying (col. 8,11. 33—35) within the temperature range of about 30 6 Appeal 2015-001317 Application 11/560,300 to 70 °C at which adherence of the antimicrobial agent to the implant material is enhanced (col. 3,11. 48—52) would not have been prima facie obvious to one of ordinary skill in the art. For the above reasons we are not persuaded of reversible error in the rejection. DECISION/ORDER The rejection of claims 2—6, 16, 33—36, 38, 39, 41, 42, 46-49, 51, 52, 58—61 and 68—74 under 35 U.S.C. § 103 over Raad in view of Darouiche and Fox is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 7 Copy with citationCopy as parenthetical citation