Ex Parte Napolitano et alDownload PDFPatent Trial and Appeal BoardMay 9, 201712855485 (P.T.A.B. May. 9, 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. 12/855,485 08/12/2010 Lisa A. Napolitano 72230/P944 9996 23363 7590 05/11/2017 T ewis; Rnra Rnthcrerher Phrisitie T T P EXAMINER PO BOX 29001 Glendale, CA 91209-9001 HELM, CARALYNNE E ART UNIT PAPER NUMBER 1615 NOTIFICATION DATE DELIVERY MODE 05/11/2017 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): pto@lrrc.com pair_cph @ firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte LISA A. NAPOLITANO, PHYLLIS VITOLO, MICHAEL V. MONTICELLO, TRAVIS DUONG, and ROY BLANK Appeal 2016-003756 Application 12/855,4851 Technology Center 1600 Before DONALD E. ADAMS, ERIC B. GRIMES, and JOHN G. NEW, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims 1—62 (App. Br. 1). Examiner entered rejections under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. 1 Appellants identify the real party in interest as “Professional Disposables International, Inc.” (App. Br. 1.) Appeal 2016-003756 Application 12/855,485 STATEMENT OF THE CASE Appellants disclose “disinfecting wipe products and compositions” (Spec. 11). Claims 1,11, and 46 are representative and reproduced below: 1. An antimicrobial wipe for use on hard surfaces comprising: (a) an absorbent substrate; and (b) a liquid composition comprising: (i) about 0.01 w/w % to about 1.0 w/w % of C12- Cis alkyl dimethyl benzyl ammonium chloride, C12-C14 alkyl dimethyl ethylbenzyl ammonium chloride, or mixtures thereof; (ii) about 0.05 w/w % to about 6.0 w/w % of a 1,2- alkanediol; (iii) about 0.5 w/w % to about 7.5 w/w % of dipropylene glycol mono-n-butyl ether, dipropylene glycol mono-n-propyl ether, or mixtures thereof; (iv) about 0.01 w/w % to about 3.0 w/w % of an ethoxylated nonionic surfactant; and (v) the balance being water; wherein the substrate is impregnated with the composition at a loading level from about 1.5 xow[2] to about 10 xow; said antimicrobial wipe being effective to treat a hard surface to kill mycobacterium on the hard surface by wiping with the antimicrobial wipe, and said antimicrobial wipe meeting the United States Environmental Protection Agency’s DIS/TSS-6 Efficacy Data Requirements for Supplemental Efficacy Claims with respect to mycobacterium tuberculosis. (App. Br. 31.) 2 Appellants define the acronym “xow” as “times the original weight of the wipe” (Spec. 123). 2 Appeal 2016-003756 Application 12/855,485 11. The antimicrobial wipe of claim 1, wherein the 1,2- alkanediol is 1,2-octanediol. {Id. at 33.) 46. A method of disinfecting a surface having mycobacterium thereon comprising: applying an effective amount of a disinfecting composition onto a hard surface, using an applicator containing the disinfecting composition, said disinfecting composition comprising: about 0.01 w/w % to about 1.0 w/w % of C12-C18 alkyl dimethyl benzyl ammonium chloride, C12-C14 alkyl dimethyl ethylbenzyl ammonium chloride, or mixtures thereof; about 0.05 w/w % to about 6.0 w/w % of a 1,2- alkanediol; about 0.5 w/w % to about 7.5 w/w % of dipropylene glycol mono-n-butyl ether, dipropylene glycol mono-n-propyl ether, or mixtures thereof; about 0.01 w/w % to about 3.0 w/w % of a nonionic surfactant; a pH regulating agent to make the pH of the composition between about 5.0 and about 11.5; and water; wherein said disinfecting composition disinfects the hard surface and kills the mycobacterium thereon, and said disinfecting composition meets the United States Environmental Protection Agency’s DIS/TSS-6 Efficacy Data Requirements for Supplemental Efficacy Claims with respect to mycobacterium tuberculosis. (App. Br. 41^2.) 3 Appeal 2016-003756 Application 12/855,485 The claims stand rejected as follows: Claims 1—14, 17—31, 37, 38, 41—45, 53—56, and 59—62 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Mitra,3 Yao,4 DuPont,5 and Hyamine.6 Claims 1, 12, 13, 21—32, and 53—56 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Mitra, Yao, Michels,7 DuPont, and Hyamine. Claims 46—52, 57, and 58 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Mitra, Yao, DuPont, Hyamine, and McCue.8 Claims 15, 16, 39, and 40 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Mitra, Yao, DuPont, Hyamine, Schmid,9 and Zander.10 Claims 33—36 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Mitra, Yao, Michels, DuPont, Hyamine, Schmid, and Zander. 3 Mitra et al., US 6,951,834 B2, issued Oct. 4, 2005. 4 Yao et al., US 2010/0069861 Al, published Mar. 18, 2010. 5 DuPont™ Spunlace Filtration Media TECHNICAL INFORMATION, www.FiltrationSolutions.dupont.com. 6 Hyamine 3500 80% (Barquat MB-50), http://www.bkwell.com/bkherbwell/cosmetic-raw- materials/Antibacterial/Hyamine-3500-... (last accessed Feb. 25, 2012). 7 Michels et al., US 2007/0037721 Al, published Feb. 15, 2007. 8 McCue et al., US 5,908,854, issued June 1, 1999. 9 Schmid et al., US 2008/0142023 Al, published June 19, 2008. 10 Zander et al., US 4,341,527, issued July 27, 1982. 4 Appeal 2016-003756 Application 12/855,485 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Mitra discloses a “general purpose cleaning wipe which includes a wipe combined with a liquid cleaning composition having a biocide and a biocide release agent” (Mitra 1: 13—16; see id. at 2: 37-40; Final Act.11 3). FF 2. Mitra’s “cleaning composition is typically formulated to clean hard surface counter tops; however, the [] cleaning composition has much broader applications and [can] be used as a clean glass cleaner, appliance cleaner, hard surface cleaner, floor cleaner, dishwashing cleaner, and the like,” wherein “the term ‘hard surface’ includes, but is not limited to . . . appliances . . . utility devices (e.g., telephones . . .)” and “the fields of use [] include, but are not limited to . . . health care (e.g., hospitals, urgent care facilities, clinics, nursing homes, medical/dental office, laboratories)” (Mitra 2: 41—67; see Ans. 4—5). FF 3. Mitra discloses the “[cjommon types of bacteria that are destroyed by [Mitra’s] cleaning composition include, but are not limited to, Staphylococcus aureus (Staph), Kleb, Salmonella choleraesuis {Salmonella), Pseudomonas aeruginosa, Serratia marcescens, Influenza A2, Candida albicans, Fusarium solani, common viruses and/or fungi” (Mitra 24: 4—10 and 48—54). 11 Examiner’s December 24, 2014 Final Office Action. 5 Appeal 2016-003756 Application 12/855,485 FF 4. Examiner finds that Mitra exemplifies a wipe loaded with a composition comprising the ingredients listed in Mitra’s EXAMPLE 23: EXAMPLE 25 BASQUAT 205M 0,15-0,4% &8S-085& Dspsiasaks dDlA IsspKjpsaasl 2,^-4% SssEjaic Li®® Fis^Tssacs si kss? Afessss Wherein “Surfonic LI08 is an ethoxylated nonionic surfactant, BARQUAT 205M is a quaternary ammonium salt, isopropanol is an alcohol, and PnB is propylene glycol mono-n-butyl ether” (Final Act. 3^4; see generally Mitra 31: 11—47.) FF 5. Examiner finds that Mitra’s wipe comprises a substrate loaded with “3.5xow to 4xow” of Mitra’s composition, wherein Mitra’s liquid composition is “absorbe[d] [into the] wipe via soaking, spraying, or impregnating where [] pre-moistened wipes are packaged in a dispenser” (Final Act. 4; citing Mitra 4: 26—34 and 58—66). FF 6. Examiner finds that Mitra discloses the use of “BARQUAT 205 M [] an alkyl benzyl ammonium chloride as well as BARQUAT MB-50 [] a similar cationic biocide that is an alkyl dimethyl benzyl ammonium chloride (Final Act. 4, citing Mitra 9: 48—55). FF 7. Examiner finds that “BARQUAT MB-50 is a mixture of Cn, Cm and Ci6 dimethyl benzyl ammonium chloride” (Final Act. 4, citing Hyamine). 6 Appeal 2016-003756 Application 12/855,485 FF 8. Examiner finds that Mitra’s substrate may be “Dupont™ 8838 [] a nonwoven wood pulp-polyester blend with a basis weight of 51 g/m2” (Final Act. 4, citing Mitra 23: 3—9 and DuPont). FF 9. Examiner finds that Mitra discloses the use of “PnB, as well as DPnB, dipropylene glycol mono-n-butyl ether” (Final Act. 4, citing Mitra 25: 51-53). FF 10. Examiner finds that Mitra discloses “[t]he addition of pH regulating agents [] in order to yield a pH of 7.2 to 10.5” (Final Act. 4, citing Mitra 21: 36-43). FF 11. Examiner finds that Mitra does not exemplify a composition comprising each quaternary ammonium salt or solvent within the scope of Mitra, a composition comprising “1,2-alkanediol, or the precise order for the combination of components in the composition” (Final Act. 5). FF 12. Yao “relates generally to an absorbent article and, in particular, to an absorbent article having antimicrobial properties” (Yao 11; see generally Ans. 5). FF 13. Examiner finds that Yao discloses “that 1, 2-alkanediols [sic],” such as 1,2-octanediol, “act synergistically with antibacterial compounds to increase their efficacy” (Final Act. 5, citing Yao 118). FF 14. Yao discloses that “benzalkonium compounds (e.g., benzalkonium chloride, and a mixture of benzalkonium chloride, silver nitrate)” are “suitable antimicrobial agents for use in the embodiments described” by Yao (Yao 115; see also Final Act. 5 (“Benzalkonium chlorides, [are] another name for the compounds of BARQUAT MB-50”)). 7 Appeal 2016-003756 Application 12/855,485 FF 15. Examiner finds that Yao discloses that antibacterial compositions comprising 0.5% 1,2-alkanediols are useful for “inclus[ion] on absorbent materials” (Final. Act. 5, citing Yao 119). FF 16. Yao discloses that [n]ot all antimicrobial agents can kill or inhibit the growth of all microbes. Rather, any one particular antimicrobial agent generally has a range of microbe types that the antimicrobial agent is effective against. As such, a variety of antimicrobial agents and/or combinations of antimicrobial agents may be applied to [Yao’s] absorbent layer [] to provide protection against a broad range of microbes. (Yao 115.) FF 17. McCue discloses “disinfectant compositions which are effective against Mycobacterium terrae” (McCue 1: 5—8; see Final Act. 8). FF 18. McCue discloses compositions comprising “a germicidal cationic quaternary ammonium compound,” such as “BARQUAT® MB-50” or “BARQUAT® 205M” (McCue 1: 66-2: 8 and 3: 5-18; Final Act. 8). FF 19. Examiner finds that McCue discloses the use of disinfectant compositions for application to hard surfaces, such as those employed in health care (Final Act. 8, citing McCue 4: 51—5: 24). FF 20. Examiner finds that Schmid discloses “antimicrobial compositions that include quaternary ammonium salts as the antimicrobial active [and] Zonyl surfactants as well as Triton X-100, the commercial name for polyethylene glycol p-(l,l,3,3-tetramethylbutyl)phenyl ether, as nonionic surfactants envisioned for inclusion in such compositions” (Final Act. 9—10, citing Schmid ^fl[ 70 and 133 and Zander 5: 8—11). FF 21. Examiner relies on Michels to disclose “moistened wipes for cleaning surfaces,” which comprise “n-alkyl dimethyl benzyl ammonium 8 Appeal 2016-003756 Application 12/855,485 chlorides, a category to which BARQUAT MB-50 belongs” and “dipropylene glycol mono-n-butyl ether as well as dipropylene glycol mono- n-propyl ether” (Final Act. 12, citing Michels Tflf 2, 88, and 174). FF 22. Vitolo declares that based on tests using Mycobacterium bovis-BCG, “a composition including both a quaternary ammonium salt and a 1,2- alkanediol, such as those recited in [Appellants’] claims 1,21, 38, 41, 43, and 46 [], exhibits unexpectedly improved tuberculocidal effects over a composition that does not include both a quaternary ammonium salt and a 1, 2-alkanediol [sic]” (Vitolo Deck1212; see also id. ^fl[ 3—7). ANALYSIS The combination of Mitra, Yao, DuPont, and Hyamine, with or without Michels'. Based on the combination of Mitra, Yao, DuPont, and Hyamine, with or without Michels, Examiner concludes that, at the time Appellants’ invention was made, it would have been prima facie obvious “to exchange BARQUAT MB-50 for the BARQUAT 205M in the composition of [Mitra’s] example 23 as a quaternary ammonium salt of similar structure that is also envisioned for the same purpose in the composition,” “exchange dipropylene glycol mono-n-butyl ether for the propylene glycol mono-n- butyl ether in [Mitra’s] composition as a similarly structured solvent also envisioned for the same purpose,” and “add 1, 2-octanediol [sic] at the percentage taught by Yao [] (interpreted as a wt/wt percentage) to [Mitra’s] composition so as to enhance the antimicrobial activity of the BARQUAT MB-50 based upon the teachings of Yao” (Final Act. 5—6 and 12—13). Examiner recognizes that the combination of Mitra, Yao, DuPont, and 12 Declaration of Phyllis Vitolo, signed January 28, 2013. 9 Appeal 2016-003756 Application 12/855,485 Hyamine is “silent in regard to the ability of the wipe to meet the DIS/TSS-6 efficacy data requirements and kill mycobacterium [as] recited in [Appellants’] claims,” but reasons that “[t]he resulting modified formulation has all the claimed components at the claimed proportions, therefore the recognition that products of the instant invention have a particular type of efficacy is not enough to distinguish the claimed composition from” the composition suggested by the combination of Mitra, Yao, DuPont, and Hyamine (Final Act. 7 and 13—14). Claims 1, 11, 21, 27, 28, 38, 41, and 43: On this record, Examiner finds that the prior art directs a person of ordinary skill in this art to an antimicrobial wipe comprising the same ingredients in the same amounts as are required by Appellants’ claimed invention (Final Act. 7 and 13—14; FF 1—16). Further, Examiner finds that Yao discloses “that 1, 2-alkanediols [sic],” such as 1,2-octanediol, “act synergistically with antibacterial compounds[, such as those disclosed by Mitra,] to increase their efficacy” (FF 6, 7, 13, and 14). “Synergism, in and of itself, is not conclusive of unobviousness in that synergism might be expected.” In re Kollman, 595 F.2d 48, 55 n.6 (CCPA 1979). “To be particularly probative, evidence of unexpected results must establish that there is a difference between the results obtained and those of the closest prior art, and that the difference would not have been expected by one of ordinary skill in the art at the time of the invention.” Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014). Therefore, we are not persuaded by Appellants’ contentions regarding “unexpectedly improved tuberculocidal effect as compared to compositions 10 Appeal 2016-003756 Application 12/855,485 that do not include [Yao’s] 1,2-alkanediol, such as those disclosed in Mitra” (App. Br. 9—21 and 22—27; Reply Br. 1—5; see FF 22; cf. Final Act. 5—6 and 12-13). Claim 32: For the reasons set forth above Appellants’ claim 21 is prima facie obvious over the combination of Mitra, Yao, DuPont, and Hyamine, with or without Michels. Claim 32 stands rejected over the combination of Mitra, Yao, DuPont, Hyamine, and Michels (see Final Act. 9-10). Therefore, consistent with Appellants’ claim grouping, as it relates to the rejections of record, Appellants’ claim 32 falls with claim 21 (see App. Br. 18). The combination of Mitra, Yao, DuPont, Hyamine, Schmid, and Zander, with or without Michels: Based on the combination of Mitra, Yao, DuPont, Hyamine, Schmid, and Zander, Examiner concludes that, at the time Appellants’ invention was made, it would have been prima facie obvious “to include polyethylene glycol p-(l,l,3,3-tetramethylbutyl)phenyl ether in the composition” suggested by the combination of Mitra, Yao, DuPont, and Hyamine, with or without Michels, “instead of Zonyl FSO,” which is exemplified in Mitra’s Example 23 (Final Act. 10 and 15; FF 1—16 and 20). Claims 15, 16, and 33—36: Appellants do not contest the rejection of claims 15, 16, and 33—36. To the contrary, Appellants group: (i) claims 15 and 16 with claim 1 and (ii) claims 33—36 with claim 21. Having found claims 1 and 21 prima facie obvious over the combination of Mitra, Yao, DuPont, and Hyamine, with or 11 Appeal 2016-003756 Application 12/855,485 without Michels, we find no error in Examiner’s undisputed rejection of claims 15 and 33 over the combination of Mitra, Yao, DuPont, Hyamine, Schmid, and Zander, without or with Michels respectively (Final Act. 3—8 and 10-14; FF 1—16, 20, and 21; cf. App. Br. 16 and 18). Claim 39: Appellants contend that “[t]he cited references, either alone or in combination, fail to disclose, teach or suggest the composition recited in claim 39” (App. Br. 22). We are not persuaded. To the contrary, as Examiner explains, the combination of references relied upon by Examiner suggest a composition comprising ingredients, as required by Appellants’ claimed invention, at concentration ranges that “fully lie inside of or overlap those claimed” (Ans. 8). “[Wjhere there is a range disclosed in the prior art, and the claimed invention falls within that range, there is a presumption of obviousness.” Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004); see also In re Geisler, 116 F.3d 1465, 1468 (Fed. Cir. 1997) (Overlapping ranges support a prima facie case of obviousness). Further, “where[, as here,] the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955). In addition, we are not persuaded by Appellants’ assertion that the claimed composition exhibits unexpected properties, because Yao teaches that 1,2-alkanediols, such as 1,2-octanediol, act synergistically with antimicrobial agents to enhance their antimicrobial efffect (FF 13). 12 Appeal 2016-003756 Application 12/855,485 The combination of Mitra, Yao, DuPont, Hyamine, and McCue: Based on the combination of Mitra, Yao, DuPont, Hyamine, and McCue, Examiner concludes that, at the time Appellants’ invention was made, it would have been prima facie obvious to use the wipe suggested by the combination of Mitra, Yao, DuPont, and Hyamine to disinfect “a hard surface with mycobacteria thereon” (Final Act. 8). Claims 50—52: Appellants do not contest the rejection of Appellants’ antimicrobial wipe and composition claims 50-52. To the contrary, Appellants group: (i) claim 50 with claim 1, (ii) claim 51 with claim 21, and (iii) claim 52 with claim 38. Having found claims 1,21, and 38 prima facie obvious over the combination of Mitra, Yao, DuPont, and Hyamine we find no error in Examiner’s undisputed rejection of claims 50, 51, and 52 over the combination of Mitra, Yao, DuPont, Hyamine, and McCue (Final Act. 3—8; FF 1—19; cf. App. Br. 16, 18, and 21). Claims 46—49, 57, and 58: The method of disinfecting a surface having mycobacterium thereon, as set forth in Appellants’ claim 46 requires, inter alia, applying an effective amount of a disinfecting composition onto a hard surface, using an applicator containing the disinfecting composition, . . . wherein [the] disinfecting composition disinfects the hard surface and kills the mycobacterium thereon, and [the] disinfecting composition meets the United States Environmental Protection Agency’s DIS/TSS-6 Efficacy Data Requirements for Supplemental Efficacy Claims with respect to mycobacterium tuberculosis. (App. Br. 41^42.) 13 Appeal 2016-003756 Application 12/855,485 At best, Examiner established that a composition comprising “a germicidal cationic quartemary ammonium compound” is “effective against Mycobacterium terrae” and may be used to disinfect hard surfaces (FF 17— 20). Notwithstanding Examiner’s assertion to the contrary, we are not persuaded that “[i]n light of [McCue’s disclosure relating to Mycobacterium terrae] it would have been obvious to one of ordinary skill in the art to use the wipe of Mitra [] in view of Yao [] to wipe a hard surface with mycobacteria thereon so as to disinfect the surface” in the manner specifically required by Appellants’ claimed invention (Final Act. 8—9). Stated differently, Examiner failed to establish an evidentiary basis on this record to support a conclusion that the combination of Mitra, Yao, DuPont, Hyamine, and McCue makes obvious Appellants’ claimed invention. CONCEUSION OF FAW The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness with respect to claims 1, 11, 15, 21, 27, 28, 33, 38,39,41,43, and 50-52. The rejection of claims 1, 11, 21, 27, 28, 38, 41, and 43 under 35 U.S.C. § 103(a) as unpatentable over the combination of Mitra, Yao, DuPont, and Hyamine is affirmed. Claims 2—10, 12—14, 17—20, 53, and 54 fall with claim 1. Claims 22—26, 55, and 56 fall with claim 21. Claims 28—31 and 37 fall with claim 27. Claim 42 falls with claims 41. Claims 44, 45, 61, and 62 fall with claim 43. Claims 59 and 60 fall with claim 38. The rejection of claims 1,21, 27, and 32 under 35 U.S.C. § 103(a) as unpatentable over the combination of Mitra, Yao, Michels, DuPont, and 14 Appeal 2016-003756 Application 12/855,485 Hyamine is affirmed. Claims 12, 13, 53, and 54 fall with claim 1. Claims 22—26, 55, and 56 fall with claim 21. Claims 28—31 fall with claim 27. The rejection of claims 15 and 39 under 35 U.S.C. § 103(a) as unpatentable over the combination of Mitra, Yao, DuPont, Hyamine, Schmid, and Zander is affirmed. Claim 16 is not separately argued and falls with claim 15. Claim 40 is not separately argued and falls with claim 39. The rejection of claim 33 under 35 U.S.C. § 103(a) as unpatentable over the combination of Mitra, Yao, Michels, DuPont, Hyamine, Schmid, and Zander is affirmed. Claims 34—36 are not separately argued and fall with claim 33. The rejection of claims 50-52 under 35 U.S.C. § 103(a) as unpatentable over the combination of Mitra, Yao, DuPont, Hyamine, and McCue is affirmed. The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness with respect to claims 46-49, 57, and 58. The rejection of claims 46-49, 57, and 58 under 35 U.S.C. § 103(a) as unpatentable over the combination of Mitra, Yao, DuPont, Hyamine, and McCue is reversed. TIME PERIOD FOR RESPONSE 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-IN-PART 15 Copy with citationCopy as parenthetical citation