Ex Parte Macinga et alDownload PDFPatent Trial and Appeal BoardDec 2, 201611647952 (P.T.A.B. Dec. 2, 2016) 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. GOJ.P.147 3170 EXAMINER WESTERBERG, NISSA M ART UNIT PAPER NUMBER 1618 MAIL DATE DELIVERY MODE 11/647,952 12/29/2006 David R. Macinga 26360 7590 12/05/2016 Renner Kenner Greive Bobak Taylor & Weber Co., LPA First National Tower, Suite 400 106 South Main Street Akron, OH 44308-1412 12/05/2016 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 PATENT TRIAL AND APPEAL BOARD Ex parte DAVID R. MACINGA, MARCIA SNYDER, and JAMES W. ARBOGAST Appeal 2014-005011 Application 11/647,9521 Technology Center 1600 Before CHRISTOPHER G. PAULRAJ, JACQUELINE T. HARLOW, and DAVID COTTA, Administrative Patent Judges. COTTA, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a method for pre-surgical hand disinfection. The Examiner rejected the claims on appeal as obvious under 35 U.S.C. § 103(a) and on the ground of non- statutory obviousness-type double patenting. We affirm. 1 According to Appellants, the real party in interest is GOJO Industries, Inc. App. Br. 2. Appeal 2014-005011 Application 11/647,952 STATEMENT OF THE CASE Claims 13, 15—17, 31 are on appeal.2 Claim 13 is illustrative and reads as follows: 13. A method for pre-surgical hand disinfection, the method comprising: contacting the skin with an effective amount of a disinfecting composition comprising at least about 50 percent by weight of a Ci_6 alcohol, based upon the total weight of the disinfecting composition; an acid; and a cationic oligomer or polymer, wherein the composition includes less than 0.5 percent by weight of auxiliary antimicrobial agents, and wherein the composition provides a log kill of at least about 3 against resident and transient skin flora in less than about 3 minutes, according to the FDA TFM surgical hand scrub test. Claim Appendix (emphasis added). The claims stand rejected as follows: Claims 13, 15—17, and 31 are rejected under 35 U.S.C. § 103(a) as unpatentable over Modak3 alone or in view of Scholz.4 Claims 13, 15—17, and 31 are provisionally rejected on the ground of non-statutory obviousness-type double patenting over claims 70-72, 75—78, 81, 93—95, and 111—138 of copending Application No. 11/670,114 (“the ‘114 Application”). 2 In the Examiner’s Answer, the Examiner stated that all rejections under 35 U.S.C. § 103(a) for claims 33—35 were withdrawn. Claim 35 was found allowable, claims 33 and 34 were deemed allowable, but depend from a rejected claim. Ans. 3. These claims are thus no longer part of this appeal. 3 Modak et al., US Patent Publication No. 2004/0247685 Al, published Dec. 9, 2004 (“Modak”). 4 Scholz et al., US Patent Publication No. 6,352,701 Bl, issued Mar. 5, 2002 (“Scholz”). 2 Appeal 2014-005011 Application 11/647,952 REJECTION OVER MODAK, ALONE, OR IN VIEW OF SCHOLZ The Examiner found that Modak disclosed a hydroalcoholic antimicrobial scrub and taught potential components including a Ci_6 alcohol, an acid, and a cationic oligomer or polymer. Ans. 3^4. The Examiner further found that additional antimicrobial agents were optional, but that when they were used they could be used in concentrations as low as 0.05% for biguanides and 0.1% for triclosan. Id. at 3. Among the embodiments disclosed in Modak was an embodiment comprising 70% isopropanol (a Ci_6 alcohol) and 0.3% U CARE® JR (polyquatemium-10, a cationic polymer) and an embodiment comprising 62% ethanol (another Ci 6 alcohol) and 0.3% U CARE® JR. Id. The Examiner found that while Modak disclosed each of the claimed components (Ci_6 alcohol, an acid, and a cationic oligomer or polymer) as potential components of an antimicrobial scrub, it did not exemplify a composition containing all three components at the same time. Id. at 4. The Examiner concluded, however, that it would have been obvious to add an acid to disclosed embodiments including isopropanol or ethanol (Ci_6 alcohols) and U CARE® JR (a cationic polymer). Id. With respect to the requirement of claim 13 that the composition not include an auxiliary antimicrobial in excess of 0.5% by weight, the Examiner concluded that antimicrobial agents were “only an optional additional ingredient,” citing claim 6 of Modak as support. Id. at 3. The Examiner noted that the biguanide and triclosan antimicrobials disclosed in Modak were present below the 0.5% limit recited in claim 13. Id. The Examiner found that Scholz taught that “[ajntimicrobials such as chlorhexidine or biguanides can be added to enhance the antimicrobial 3 Appeal 2014-005011 Application 11/647,952 action but are an optional ingredient.” Id. at 6. Based on this disclosure, the Examiner concluded: It would have been obvious to the person of ordinary skill in the art at the time the invention was made to omit the auxiliary antimicrobials from alcoholic skin disinfectant compositions. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Scholz et al. clearly discloses that efficacious antimicrobial action can be achieved with lower alcohols alone without additional antimicrobial agents. Id. at 6. Appellants argue, inter alia, that the Modak does not render the claimed method obvious because Modak requires auxiliary antimicrobial components in excess of the 0.5% limit recited in the claims on appeal. App. Br. 6. Appellants contend that Sholz does not remedy the deficiencies of Modak and, in fact, “teaches the need for secondary antimicrobials, particularly in critical uses such as presurgical hand scrubs or presurgical patient skin scrub replacements.” Id. at 7. We find that Appellants have the better position. The term “auxiliary antimicrobial agent” is broadly defined in the Specification, which states: “Any antimicrobial ingredient other than the combination of alcohol, acid, and a cationic oligomer or polymer may be referred to as an auxiliary antimicrobial agent.” Specification | 53. While octoxyglycerin is an emollient, the Examiner concedes that it is also an antimicrobial. Ans. 3; see also, Modak at 115 (“Octoxyglycerin exhibits antimicrobial activity against a variety of Gram-positive bacteria associated with perspiration odor . . .”). The Examiner does not argue or 4 Appeal 2014-005011 Application 11/647,952 identify any evidence suggesting that octoxyglycerine is a Ci_6 alcohol, an acid, or a cationic oligomer or polymer. Accordingly, we conclude that octoxyglycerin is an “auxiliary antimicrobial agent” as that term is used in claim 13. Modak teaches that its invention is a synergistic combination of octoxyglycerin with at least one additional antimicrobial. In doing so, Modak makes clear that its composition requires the presence of oxtoglycerin. See, Modak 127 (“The present invention relates to antimicrobial compositions comprising synergistic combinations of octoxyglycerin and at least one other antimicrobial agent.”); see also, id. at | 29 (“The present invention relates to combinations of octoxyglycerin with at least one, and preferably at least two, antimicrobial agents.”); and id. at | 88 (“Tables 1 and 2 show that no significant antimicrobial activity against S. aureus was obtained with 2—5 percent Sensiva [octoxyglyerin]; the antimicrobial activity was not significantly different between 2, 3 and 5 percent of Sensiva. Similarly, 0.12 and 0.19 percent BZK exhibited minimal or no antimicrobial activity (Table 2). However, combinations of 1—2 percent Sensiva SC50 and 0.12-0.19 percent BZK showed 5000-33000 fold reduction in colony-forming units compared to control values (Table 2).”) Id. at | 88. Modak teaches that the minimum amount of octoxyglycerin present is 1%. Id. at 131 (“The present invention provides for compositions comprising octoxyglycerin at between 1 and 5 percent, and preferably 1 -3 percent.”). As this exceeds the 0.5% threshold recited in the claims on appeal, one would need to modify the compositions of Modak to meet the requirements of the claims on appeal. 5 Appeal 2014-005011 Application 11/647,952 The Examiner contends that “it would have been obvious to the person of ordinary skill in the art at the time the invention was made to omit the auxiliary antimicrobials” because Scholz teaches that “efficacious antimicrobial action can be achieved with lower alcohols alone without additional antimicrobial agents.” Ans. 6. The relevant passage from Scholz that the Examiner relied upon reads as follows: In addition to the lower alcohols present in the composition of the present invention, other antimicrobials may be added to enhance the antimicrobial action of the compositions of the present invention. This may be particularly desirable in critical uses such as presurgical hand scrubs or presurgical patient skin scrub replacements. Scholz, col. 20,11. 7—12. Even if we were to accept the Examiner’s interpretation that the above passage teaches that “efficacious antimicrobial action can be achieved with lower alcohols alone,” nothing in the above passage provides motivation to eliminate (or reduce the amount of) octoxyglycerine in the compositions of Modak, particularly given Modak’s emphasis on the synergistic combination of octoxyglycerin and another antimicrobial. We thus find that the record as presently constituted does not support the Examiner’s conclusion that a person of ordinary skill in the art would have been motivated to omit or reduce the amount of octoxyglycerin in the composition of Modak. Accordingly, we reverse the Examiner’s rejection of claims 13, 15—17 and 31 as obvious over the combination of Modak alone or in view of Scholz. 6 Appeal 2014-005011 Application 11/647,952 DOUBLE PATENTING REJECTION The Examiner provisionally rejected claims 13, 15—17, and 31 over claims 70-72, 75—78, 81, 93—95, and 111—138 of the ‘114 Application. Claim 70 of the ‘ 114 Application currently reads as follows: 70. A virucidally-enhanced alcoholic composition comprising: greater than 50 wt. % of a Ci_6 alcohol, based upon the total weight of said alcoholic composition; an effective amount of a copper ion or compound; and an efficacy-enhancing amount of an enhancer selected from the group consisting of cationic oligomers and polymers, wherein the amount of acid is less than 0.05 wt.%, based upon the total weight of said alcoholic composition; and wherein said virucidally-enhanced alcoholic composition exhibits an efficacy against nonenveloped viruses that is higher than the efficacy of the same composition but not comprising said enhancer. Claim Appendix, May 11,2015 Appeal Brief filed in connection with the ‘114 Application. Appellants argue that the claimed method is nonobvious over the claims of the ‘144 Application because the ‘144 Application claims “do not recite methods for pre-surgical hand disinfection” and because “claim 70 limits the amount of acid to less than 0.05 wt. %, while claims 111 and 119 are silent as to whether or not the compositions contain any acid.” App Br. 17. We are not persuaded. We agree with the Examiner that given the claimed virucidal properties of the compositions of the ‘144 Application, see claims 70—72, 111, 119, it would have been obvious to apply the compositions to the skin for disinfection. See, Ans. 12. With respect to the acid component, the range recited in the claim 70 of the ‘114 Application, which requires less 7 Appeal 2014-005011 Application 11/647,952 than 0.05% acid, overlaps with the range encompassed by the claims at issue, which do not quantify the amount of acid required. This creates a prima facie case of obviousness that Appellants have not rebutted. See, In re Peterson, 315 F.3d 1325, 1329-30 (Fed. Cir. 2003) (“[T]he existence of overlapping or encompassing ranges shifts the burden to the applicant to show that his invention would not have been obvious.”). Accordingly we affirm the Examiner’s decision to provisionally reject claims 13, 15—17, and 31 on the ground of non-statutory obviousness-type double patenting over claims 70—72, 75—78, 81, 93—95, and 111—138 of the ‘114 Application. SUMMARY For these reasons and those set forth in the Examiner's Answer, the Examiner's final decision to reject claims 13, 15—17, and 31 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)(1). AFFIRMED 8 Copy with citationCopy as parenthetical citation